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MS212100 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Therapeutic trials often attempt to “ blind ” patient and investigator to the true nature of treatments received , reducing the influences of conscious or subconscious prejudices . In drug trials , this is accomplished with placebo tablets , but blinding in trials of physical treatments is more problematic . This issue arose in a clinical trial of transcutaneous electrical nerve stimulation ( TENS ) for patients with chronic low back pain . Several study design features were incorporated to promote blinding : use of sham TENS units visually identical with real units , exclusion of potential subjects with previous TENS experience , avoidance of a crossover design and use of identical visit frequency , instructions and modifications in electrode placement . Subjects were asked not to discuss treatments with the clinicians who performed outcome assessment s. Both patients and clinicians were asked to guess actual treatment assignments at the trial 's end . Every patient in the true TENS group believed the unit was functioning properly , but the degree of certainty varied . In the sham TENS group , 84 % also believed they had functioning units , but their certainty was significantly less than in the active treatment group . Differences in patient perceptions did not affect compliance , as the two groups had similar dropout rates , appointment compliance , days of TENS use and daily duration of TENS use . Clinicians guessed treatments correctly 61 % of the time ( as opposed to 50 % expected by chance ) , again suggesting partial success in blinding . These efforts at blinding may partly explain the negative trial results for TENS efficacy . We conclude that complete blinding is difficult to achieve because of sensory difference in treatment and unintended communication between patient and examiner . Nonetheless , trials of physical treatments can achieve partial blinding with the techniques described here , and the success of blinding can be assessed with simple questions at study completion The purpose of this study was to compare the effectiveness of transcutaneous nerve stimulation ( TENS ) , electroacupuncture ( EA ) , and ice massage with placebo treatment for the treatment of pain . Subjects ( n = 100 ) diagnosed with osteoarthritis ( OA ) of the knee were treated with these modalities . The parameters for evaluating the effectiveness of treatment include pain at rest , stiffness , 50 foot walking time , quadriceps muscle strength , and knee flexion degree . The results showed ( a ) that all three methods could be effective in decreasing not only pain but also the objective parameters in a short period of time ; and ( b ) that the treatment results in TENS , EA and ice massage were superior to placebo OBJECTIVE To evaluate and compare the effects of locally applied heat and cold treatments on skin and intraarticular temperature in patients with arthritis . METHODS Thirty-nine patients with arthritis of the knee were divided at r and om into 4 treatment groups ( ice chips , nitrogen cold air , ligno-paraffin , and placebo short wave ) . A temperature probe was inserted into the knee joint cavity and another placed on the overlying skin , and changes in temperature over 3 hours were recorded for each treatment group . RESULTS The mean temperature of the surface of the skin dropped from 32.2 degrees C to 16.0 degrees C after application of ice chips and from 32.6 degrees C to 9.8 degrees C after application of nitrogen cold air ; the mean intraarticular temperature decreased from 35.5 degrees C to 29.1 degrees C and from 35.8 degrees C to 32.5 degrees C , respectively , after these treatments . Treatment with ligno-paraffin increased the surface temperature by 7.5 degrees C and the temperature in the joint cavity by 1.7 degrees C. No significant changes were observed with placebo short wave diathermy . CONCLUSION The traditional model , that intraarticular temperature is decreased by superficial heat and increased by superficial cold , must be discarded . In arthritis patients , intraarticular temperature is increased by superficial heat and decreased by superficial cold . This has clear consequences for treatment policy Three rehabilitation modalities relating to in-hospital postoperative care following unilateral total knee arthroplasty ( UTKA ) were studied regarding their effect on pain management and UTKA outcome : ( 1 ) continuous passive motion ( CPM ) ; ( 2 ) CPM with transcutaneous electrical nerve stimulation ( TENS ) ; and ( 3 ) CPM with continuous cooling pad ( CCP ) . Phase I : CPM . Twenty-two UTKA patients were r and omized into two postoperative care groups : ( 1 ) 12 with CPM ; and ( 2 ) 10 with no CPM . Total hospitalization pain medication consumption was significantly less for the CPM group ( P less than .05 ) . Phase II : CPM With TENS . Forty-eight UTKA patients were r and omized into three postoperative care groups : ( 1 ) 18 with an ipsilateral thigh TENS unit delivering sensory threshold stimulation ; ( 2 ) 18 with a subthreshold TENS unit ; and ( 3 ) 12 with no TENS unit . All groups used CPM . No significant difference was found regarding pain medication consumption . Phase III : CPM With CCP . Thirty consecutive UTKA patients were divided into two postoperative care groups : ( 1 ) 15 with a CCP unit ; and ( 2 ) 15 with no CCP unit . Both groups used CPM . No significant difference was found regarding total or intramuscular hospitalization pain medication consumption . However , oral hospitalization pain medication consumption was significantly less for the CCP group ( P less than .01 ) . This postoperative UTKA study demonstrates significantly decreased total in-hospital pain medication consumption when comparing CPM vs no CPM , significantly decreased oral in-hospital pain medication consumption when comparing CPM with CCP vs CPM without CCP , but no difference when comparing CPM with TENS vs CPM without TENS . ( ABSTRACT TRUNCATED AT 250 WORDS Assessing the quality of r and omized controlled trials ( RCTs ) is important and relatively new . Quality gives us an estimate of the likelihood that the results are a valid estimate of the truth . We present an annotated bibliography of scales and checklists developed to assess quality . Twenty-five scales and nine checklists have been developed to assess quality . The checklists are most useful in providing investigators with guidelines as to what information should be included in reporting RCTs . The scales give readers a quantitative index of the likelihood that the reported methodology and results are free of bias . There are several shortcomings with these scales . Future scale development is likely to be most beneficial if questions common to all trials are assessed , if the scale is easy to use , and if it is developed with sufficient rigor The role of local heat or cold therapy used in conjunction with exercise in the rehabilitation of total knee arthroplasty patients was investigated . Thirty-six osteoarthritic patients were analyzed . Parameters evaluated were range of motion , swelling about the knee , and pain . All patients received the total condylar knee prosthesis and began range of motion rehabilitation fourteen days after operation . Results showed that temperature alteration does not augment passive range of motion after total knee arthroplasty . It was also shown that cold application decreases swelling as compared with heat . Additionally , the application of cold partially alleviates the discomfort of the rehabilitation process in certain patients
Output:
| Another trial showed that cold packs decreased knee edema .
REVIEW ER 'S CONCLUSIONS Ice massage compared to control had a statistically beneficial effect on ROM , function and knee strength .
Cold packs decreased swelling .
Hot packs had no beneficial effect on edema compared with placebo or cold application .
Ice packs did not effect pain significantly compared to control in patients with OA . |
MS212101 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Diarrhoea and respiratory infections remain the biggest killers of children under 5 years in developing countries . We conducted a 5-month household r and omised controlled trial among 566 households in rural Rw and a to assess uptake , compliance and impact on environmental exposures of a combined intervention delivering high-performance water filters and improved stoves for free . Compliance was measured monthly by self-report and spot-check observations . Semi-continuous 24-h PM2.5 monitoring of the cooking area was conducted in a r and om sub sample of 121 households to assess household air pollution , while sample s of drinking water from all households were collected monthly to assess the levels of thermotolerant coliforms . Adoption was generally high , with most householders reporting the filters as their primary source of drinking water and the intervention stoves as their primary cooking stove . However , some householders continued to drink untreated water and most continued to cook on traditional stoves . The intervention was associated with a 97.5 % reduction in mean faecal indicator bacteria ( Williams means 0.5 vs. 20.2 TTC/100 mL , p<0.001 ) and a median reduction of 48 % of 24-h PM2.5 concentrations in the cooking area ( p = 0.005 ) . Further studies to increase compliance should be undertaken to better inform large-scale interventions . Trial registration : Clinical trials.gov ; NCT01882777 ; http:// clinical trials.gov/ct2/ results ? term = NCT01882777 & Search = Background Acute lower respiratory infections ( ALRI ) are a leading cause of death among children . Low birthweight is prevalent in South Asia and associated with increased risks of mortality , and morbidity , high levels of indoor household air pollution caused by open burning of biomass fuels are common and associated with high rates of ALRI and low birthweight . Alternative stove design s that burn biomass fuel more efficiently have been proposed as one method for reducing these high exposures and lowering rates of these disorders . We design ed two r and omized trials to test this hypothesis . Methods / design We conducted a pair of community-based , r and omized trials of alternative cookstove installation in a rural district in southern Nepal . Phase one was a cluster r and omized , modified step-wedge design using an alternative biomass stove with a chimney . A pre-installation period of morbidity assessment and household environmental assessment was conducted for six months in all households . This was followed by a one year step-wedge phase with 12 monthly steps for clusters of households to receive the alternative stove . The timing of alternative stove introduction was r and omized . This step-wedge phase was followed in all households by another six month follow-up phase . Eligibility criteria for phase one included household informed consent , the presence of a married woman of reproductive age ( 15–30 yrs ) or a child < 36 months . Children were followed until 36 months of age or the end of the trial . Pregnancies were identified and followed until completion or end of the trial . Phase two was an individually r and omized trial of the same alternative biomass stove versus liquid propane gas stove in a subset of households that participated in phase one . Follow-up for phase two was 12 months following stove installation . Eligibility criteria included the same components as phase one except children were only enrolled for morbidity follow-up if they were less than 24 months . The primary outcomes included : incidence of ALRI in children and birthweight . Discussion We presented the design and methods of two r and omized trials of alternative cookstoves on rates of ALRI and birthweight . Trial registration Clinical trials.gov ( NCT00786877 , Nov. 5 , 2008 ) During the first r and omized intervention trial ( RESPIRE : R and omized Exposure Study of Pollution Indoors and Respiratory Effects ) in air pollution epidemiology , we pioneered application of passive carbon monoxide ( CO ) diffusion tubes to measure long-term personal exposures to woodsmoke . Here we report on the protocol s and validations of the method , trends in personal exposure for mothers and their young children , and the efficacy of the introduced improved chimney stove in reducing personal exposures and kitchen concentrations . Passive diffusion tubes originally developed for industrial hygiene applications were deployed on a quarterly basis to measure 48-hour integrated personal carbon monoxide exposures among 515 children 0 - 18 months of age and 532 mothers aged 15 - 55 years and area sample s in a sub sample of 77 kitchens , in households r and omized into control and intervention groups . Instrument comparisons among types of passive diffusion tubes and against a continuous electrochemical CO monitor indicated that tubes responded nonlinearly to CO , and regression calibration was used to reduce this bias . Before stove introduction , the baseline arithmetic ( geometric ) mean 48-h child ( n=270 ) , mother ( n=529 ) and kitchen ( n=65 ) levels were , respectively , 3.4 ( 2.8 ) , 3.4 ( 2.8 ) and 10.2 ( 8.4 ) p.p.m . The between-group analysis of the 3355 post-baseline measurements found CO levels to be significantly lower among the intervention group during the trial period : kitchen levels : −90 % ; mothers : −61 % ; and children : −52 % in geometric means . No significant deterioration in stove effect was observed over the 18 months of surveillance . The reliability of these findings is strengthened by the large sample size made feasible by these unobtrusive and inexpensive tubes , measurement error reduction through instrument calibration , and a r and omized , longitudinal study design . These results from the first r and omized trial of improved household energy technology in a developing country and demonstrate that a simple chimney stove can substantially reduce chronic exposures to harmful indoor air pollutants among women and infants Background : Cooking with biomass fuels on open fires results in exposure to health-damaging pollutants such as carbon monoxide ( CO ) , polycyclic aromatic hydrocarbons ( PAHs ) , and particulate matter . Objective : We compared CO exposures and urinary PAH biomarkers pre- and postintervention with an improved biomass stove , the Patsari stove . Methods : In a sub sample of 63 women participating in a r and omized controlled trial in central Mexico , we measured personal CO exposure for 8 hr during the day using continuous monitors and passive sample rs . In addition , first-morning urine sample s obtained the next day were analyzed for monohydroxylated PAH metabolites by gas chromatography/isotope dilution/high-resolution mass spectrometry . Exposure data were collected during the use of an open fire ( preintervention ) and after installation of the improved stove ( postintervention ) for 47 women , enabling paired comparisons . Results : Median pre- and postintervention values were 4 and 1 ppm for continuous personal CO and 3 and 1 ppm for passive sample r CO , respectively . Postintervention measurements indicated an average reduction of 42 % for hydroxylated metabolites of naphthalene , fluorene , phenanthrene , and pyrene on a whole-weight concentration basis ( micrograms per liter of urine ) , and a 34 % reduction on a creatinine-adjusted basis ( micrograms per gram of creatinine ) . Pre- and postintervention geometric mean values for 1-hydroxypyrene were 3.2 and 2.0 μg/g creatinine , respectively . Conclusion : Use of the Patsari stove significantly reduced CO and PAH exposures in women . However , levels of many PAH biomarkers remained higher than those reported among smokers Background : A growing body of evidence indicates a relationship between household indoor air pollution from cooking fires and adverse neonatal outcomes , such as low birth weight ( LBW ) , in re source -poor countries . Objective : We examined the effect of reduced wood smoke exposure in pregnancy on LBW of Guatemalan infants in RESPIRE ( R and omized Exposure Study of Pollution Indoors and Respiratory Effects ) . Methods : Pregnant women ( n = 266 ) either received a chimney stove ( intervention ) or continued to cook over an open fire ( control ) . Between October 2002 and December 2004 we weighed 174 eligible infants ( 69 to mothers who used a chimney stove and 105 to mothers who used an open fire during pregnancy ) within 48 hr of birth . Multivariate linear regression and adjusted odds ratios ( ORs ) were used to estimate differences in birth weight and LBW ( < 2,500 g ) associated with chimney-stove versus open-fire use during pregnancy . Results : Pregnant women using chimney stoves had a 39 % reduction in mean exposure to carbon monoxide compared with those using open fires . LBW prevalence was high at 22.4 % . On average , infants born to mothers who used a stove weighed 89 g more [ 95 % confidence interval ( CI ) , –27 to 204 g ] than infants whose mothers used open fires after adjusting for maternal height , diastolic blood pressure , gravidity , and season of birth . The adjusted OR for LBW was 0.74 ( 95 % CI , 0.33–1.66 ) among infants of stove users compared with open-fire users . Average birth weight was 296 g higher ( 95 % CI , 109–482 g ) in infants born during the cold season ( after harvest ) than in other infants ; this unanticipated finding may reflect the role of maternal nutrition on birth weight in an impoverished region . Conclusions : A chimney stove reduced wood smoke exposures and was associated with reduced LBW occurrence . Although not statistically significant , the estimated effect was consistent with previous studies Background Household air pollution exposure is a major health risk , but vali date d interventions remain elusive . Methods / Design The Ghana R and omized Air Pollution and Health Study ( GRAPHS ) is a cluster-r and omized trial that evaluates the efficacy of clean fuels ( liquefied petroleum gas , or LPG ) and efficient biomass cookstoves in the Brong-Ahafo region of central Ghana . We recruit pregnant women into LPG , efficient cookstove , and control arms and track birth weight and physician-assessed severe pneumonia incidence in the first year of life . A woman is eligible to participate if she is in the first or second trimester of pregnancy and carrying a live singleton fetus , if she is the primary cook , and if she does not smoke . We hypothesize that babies born to intervention mothers will weigh more and will have fewer cases of physician-assessed severe pneumonia in the first year of life . Additionally , an extensive personal air pollution exposure monitoring effort opens the way for exposure-response analyses , which we will present alongside intention-to-treat analyses . Major funding was provided by the National Institute of Environmental Health Sciences , The Thrasher Research Fund , and the Global Alliance for Clean Cookstoves . Discussion Household air pollution exposure is a major health risk that requires well-tested interventions . GRAPHS will provide important new evidence on the efficacy of both efficient biomass cookstoves and LPG , and will thus help inform health and energy policies in developing countries . Trial registration The trial was registered with clinical trials.gov on 13 April 2011 with the identifier NCT01335490 Background Exposure to biomass fuel smoke is one of the leading risk factors for disease burden worldwide . International campaigns are currently promoting the widespread adoption of improved cookstoves in re source -limited setting s , yet little is known about the cultural and social barriers to successful improved cookstove adoption and how these barriers affect environmental exposures and health outcomes . Design We plan to conduct a one-year crossover , feasibility intervention trial in three re source -limited setting s ( Kenya , Nepal and Peru ) . We will enroll 40 to 46 female primary cooks aged 20 to 49 years in each site ( total 120 to 138 ) . Methods At baseline , we will collect information on sociodemographic characteristics and cooking practice s , and measure respiratory health and blood pressure for all participating women . An initial observational period of four months while households use their traditional , open-fire design cookstoves will take place prior to r and omization . All participants will then be r and omized to receive one of two types of improved , ventilated cookstoves with a chimney : a commercially-constructed cookstove ( Envirofit G3300/G3355 ) or a locally-constructed cookstove . After four months of observation , participants will crossover and receive the other improved cookstove design and be followed for another four months . During each of the three four-month study periods , we will collect monthly information on self-reported respiratory symptoms , cooking practice s , compliance with cookstove use ( intervention periods only ) , and measure peak expiratory flow , forced expiratory volume at 1 second , exhaled carbon monoxide and blood pressure . We will also measure pulmonary function testing in the women participants and 24-hour kitchen particulate matter and carbon monoxide levels at least once per period . Discussion Findings from this study will help us better underst and the behavioral , biological , and environmental changes that occur with a cookstove intervention . If this trial indicates that reducing indoor air pollution is feasible and effective in re source -limited setting s like Peru , Kenya and Nepal , trials and programs to modify the open burning of biomass fuels by installation of low-cost ventilated cookstoves could significantly reduce the burden of illness and death worldwide . Trial registration Clinical Trials.gov Background More than two-fifths of the world ’s population uses solid fuels , mostly biomass , for cooking . The result ing biomass smoke exposure is a major cause of chronic obstructive pulmonary disease ( COPD ) among women in developing countries . Objective To assess whether
Output:
| Our results suggest that exposure to CO is not a consistently valid surrogate measure of exposure to PM2.5 . |
MS212102 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: The presence of renal noninflammatory necrotizing vasculopathy ( NNV ) is often associated with a severe form of lupus nephritis ( LN ) , which is unresponsive to st and ard therapy . We conducted a 6-month r and omized , prospect i ve , open-label trial comparing mycophenolate mofetil ( MMF ) ( 1.5—2.0 g/day ) with monthly i.v . cyclophosphamide ( CTX ) ( 0.75—1.0 g/m2 ) as induction therapy for class IV LN with NNV . The primary and second end points were complete remission ( CR ) and partial remission ( PR ) , respectively . Of 20 patients recruited , nine were r and omly assigned to MMF and 11 to CTX . The baseline characteristics between groups were not significant . CR was achieved in four patients ( 44.4 % ) receiving MMF and in none of the patients receiving CTX ( P = 0.026 ) . PR was achieved in two patients ( 22.2 % ) in the MMF group and three patients ( 27.2 % ) in the CTX group . The total remission rate ( CR + PR ) in the MMF and CTX group was 66.6 and 27.2 % , respectively ( P = 0.17 ) . MMF was more effective than i.v . CTX in reducing proteinuria and haematuria . Adverse events were significantly less frequent with MMF than with CTX ( P = 0.028 ) . MMF was superior to i.v . CTX in inducing CR of LN with NNV and had a more favourable safety profile . Lupus ( 2007 ) 16 , 707—712 For the treatment of proliferative lupus nephritis , long-term cyclophosphamide ( CY ) regimens are efficacious , however , at the expense of substantial toxicity . In the last decade , sequential regimens of short-term CY induction followed by either mycophenolate mofetil ( MMF ) or azathioprine ( AZA ) maintenance have shown to be efficacious and safe reducing the long-term exposure to CY . In a maintenance study including predominantly Hispanics and African-Americans , the patients who received MMF and AZA maintenance had a higher cumulative probability of remaining free of the composite of death or chronic renal failure ( CRF ) compared to quarterly intravenous CY ( IVCY ) maintenance ( 89 % in MMF , 80 % , in AZA and 45 % in IVCY ) . Likewise , MMF and AZA maintenance were associated with significantly lower incidence of severe infections ( 2 % in each MMF or AZA , and 25 % in IVCY ) , sustained amenorrhea ( 6 % in MMF , 8 % in AZA , and 32 % in IVCY ) , and hospitalizations ( one hospital-days per patient-year in each MMF or AZA , and 10 in IVCY ) . In a European induction study including predominantly Caucasians , patients who received any of two sequential regimens , low dose versus high dose IVCY induction both followed by AZA maintenance , had a high cumulative probability of remaining free of treatment failure ( 84 % in low dose IVCY and 80 % in high dose IVCY ; treatment failure defined as a composite of free of corticosteroid resistant flare , nephrotic syndrome , doubling creatinine , and persistent elevated creatinine ) . Low dose IVCY and high dose IVCY induction were associated with low incidence of sustained amenorrhea ( 4 % in each group ) and severe infections ( 11 % in low dose and 22 % in high dose IVCY induction ) . Of interest , most of the severe infection episodes occurred while patients were receiving IVCY induction . Finally an Asian study demonstrated that patients with proliferative lupus nephritis could be effectively treated with short-term oral CY induction followed by AZA maintenance . The cumulative probability of complete remission was 76 % . The relapse rate was only 11 % . The incidence of permanent amenorrhea and infection were 8 % and 33 % , respectively . None of the Asian patients had an increase in serum creatinine level to double the baseline value . Maintenance therapies with MMF or AZA following short-term CY induction in a sequential regimen are efficacious and safe for the treatment of high-risk patients with proliferative lupus nephritis Recent studies have suggested that mycophenolate mofetil ( MMF ) may offer advantages over intravenous cyclophosphamide ( IVC ) for the treatment of lupus nephritis , but these therapies have not been compared in an international r and omized , controlled trial . Here , we report the comparison of MMF and IVC as induction treatment for active lupus nephritis in a multinational , two-phase ( induction and maintenance ) study . We r and omly assigned 370 patients with classes III through V lupus nephritis to open-label MMF ( target dosage 3 g/d ) or IVC ( 0.5 to 1.0 g/m(2 ) in monthly pulses ) in a 24-wk induction study . Both groups received prednisone , tapered from a maximum starting dosage of 60 mg/d . The primary end point was a prespecified decrease in urine protein/creatinine ratio and stabilization or improvement in serum creatinine . Secondary end points included complete renal remission , systemic disease activity and damage , and safety . Overall , we did not detect a significantly different response rate between the two groups : 104 ( 56.2 % ) of 185 patients responded to MMF compared with 98 ( 53.0 % ) of 185 to IVC . Secondary end points were also similar between treatment groups . There were nine deaths in the MMF group and five in the IVC group . We did not detect significant differences between the MMF and IVC groups with regard to rates of adverse events , serious adverse events , or infections . Although most patients in both treatment groups experienced clinical improvement , the study did not meet its primary objective of showing that MMF was superior to IVC as induction treatment for lupus nephritis Patients with lupus membranous nephropathy ( LMN ) are at substantial long-term risk for morbidity and mortality associated with protracted nephrotic syndrome , including ESRD . The optimal treatment for this condition is controversial . Forty-two patients with LMN participated in a r and omized , controlled trial to compare adjunctive immunosuppressive drugs with prednisone alone . Adjunctive regimens included either cyclosporine ( CsA ) for 11 mo or alternate-month intravenous pulse cyclophosphamide ( IVCY ) for six doses ; the control group received alternate-day prednisone alone . Median proteinuria was 5.4 g/d ( range 2.7 to 15.4 g/d ) . We assessed the primary outcome , time to remission of proteinuria during the 12-mo protocol , by univariate survival analysis . At 1 yr , the cumulative probability of remission was 27 % with prednisone , 60 % with IVCY , and 83 % with CsA. Although both IVCY and CsA were more effective than prednisone in inducing remissions of proteinuria , relapse of nephrotic syndrome occurred significantly more often after completion of CsA than after IVCY . By multivariate survival analysis , treatment with prednisone and high- grade proteinuria ( > 5 g/d ) but not race or ethnicity were independently associated with a decreased probability of remission . Adverse effects during the 12-mo protocol included insulin-requiring diabetes ( one with prednisone and two with CsA ) , pneumonia ( one with prednisone and two with CsA ) , and localized herpes zoster ( two with IVCY ) . In conclusion , regimens containing CsA or IVCY are each more effective than prednisone alone in inducing remission of proteinuria among patients with LMN OBJECTIVE To compare the efficacy and side effects of intermittent pulse cyclophosphamide plus methylprednisolone with continuous oral cyclophosphamide plus prednisolone , followed by azathioprine , in patients with proliferative glomerulonephritis caused by systemic lupus erythematosus ( SLE ) . METHODS A multicentre r and omised controlled trial was conducted between June 1992 and May 1996 involving eight European centres . All patients satisfied the American College of Rheumatology criteria for SLE and had biopsy proven proliferative lupus nephritis . All received corticosteroids in addition to cytotoxic drugs , as defined in the protocol , for two years . The trial was terminated after four years as recruitment was disappointing . RESULTS 32 SLE patients with lupus nephritis were recruited : 16 were r and omised to intermittent pulse cyclophosphamide and 16 to continuous cyclophosphamide plus azathioprine . Mean duration of follow up was 3.7 years in the continuous group ( range 0 to 5.6 ) and 3.3 years in the pulse group ( range 0.25 to 6 ) . Three patients were excluded from the pulse therapy group as they were later found to have pure mesangial glomerulonephritis . Two patients in the continuous therapy group developed end stage renal failure requiring dialysis , but none in the intermittent pulse therapy ( p = 0.488 ; NS ) . There were similar numbers of side effects and withdrawals from treatment in both groups . There were three deaths : two in the intermittent pulse therapy group and one in the continuous therapy group . CONCLUSIONS There was no statistically significant difference in efficacy and side effects between the two regimens . Infectious complications occurred commonly , so careful monitoring is required during treatment BACKGROUND The aim of the present study was to evaluate the efficacy of mycophenolate mofetil in the induction therapy of proliferative lupus nephritis . METHODS Forty-four patients from eight centres with newly diagnosed lupus nephritis World Health Organization class III or IV were r and omly assigned to either mycophenolate mofetil ( MMF ) 2 g/day for 6 months or intravenous cyclophosphamide ( IVC ) 0.75 - 1 g/m(2 ) monthly for 6 months in addition to corticosteroids . RESULTS Remission occurred in 13 out of 25 patients ( 52 % ) in the IVC group and 11 out of 19 patients ( 58 % ) in the MMF group ( P = 0.70 ) . There were 12 % in the IVC group and 26 % in the MMF group that achieved complete remission ( P = 0.22 ) . Improvements in haemoglobin , the erythrocyte sedimentation rate , serum albumin , serum complement , proteinuria , urinary activity , renal function and the Systemic Lupus Erythematosus Disease Activity Index score were similar in both groups . Twenty-four follow-up renal biopsies at the end of therapy showed a significant reduction in the activity score in both groups . The chronicity index increased in both groups but was only significant in the IVC group . Adverse events were similar . Major infections occurred in three patients in each group . There was no difference in gastrointestinal side-effects . CONCLUSIONS MMF in combination with corticosteroids is an effective induction therapy for moderately severe proliferative lupus nephritis OBJECTIVE In the Euro-Lupus Nephritis Trial ( ELNT ) , 90 patients with lupus nephritis were r and omly assigned to a high-dose intravenous cyclophosphamide ( IV CYC ) regimen ( 6 monthly pulses and 2 quarterly pulses with escalating doses ) or a low-dose IV CYC regimen ( 6 pulses of 500 mg given at intervals of 2 weeks ) , each of which was followed by azathioprine ( AZA ) . After a median followup of 41 months , a difference in efficacy between the 2 regimens was not observed . The present analysis was undertaken to extend the followup and to identify prognostic factors . METHODS Renal function was prospect ively assessed quarterly in all 90 patients except 5 who were lost to followup . Survival curves were derived using the Kaplan-Meier method . RESULTS After a median followup of 73 months , there was no significant difference in the cumulative probability of end-stage renal disease or doubling of the serum creatinine level in patients who received the low-dose IV CYC regimen versus those who received the high-dose regimen . At long-term followup , 18 patients ( 8 receiving low-dose and 10 receiving high-dose treatment ) had developed permanent renal impairment and were classified as having poor long-term renal outcome . We demonstrated by multivariate analysis that early response to therapy at 6 months ( defined as a decrease in serum creatinine level and proteinuria < 1 g/24 hours ) was the best predictor of good long-term renal outcome . CONCLUSION Long-term followup of patients from the ELNT confirms that , in lupus nephritis , a remission-inducing regimen of low-dose IV CYC followed by AZA achieves clinical results comparable with those obtained with a high-dose regimen . Early response to therapy is predictive of good long-term renal outcome OBJECTIVE Glomerulonephritis is a severe manifestation of systemic lupus erythematosus ( SLE ) that is usually treated with an extended course of intravenous ( IV ) cyclophosphamide ( CYC ) . Given the side effects of this regimen , we evaluated the efficacy and the toxicity of a course of low-dose IV CYC prescribed as a remission-inducing treatment , followed by azathioprine
Output:
| In terms of induction therapies , MMF did not increase complete remission or partial remission rates as compared with CYC .
However , the relative risks ( RRs ) of amenorrhea and leukopenia tended to be lower in the MMF group than in the CYC group .
Meta- analysis of MMF versus AZA as a maintenance therapy showed no difference between the two groups in terms of response rates or the risk of developing end-stage renal disease .
In conclusion , MMF was found to be as effective as CYC and tended to have a better safety profile as an induction therapy for LN than CYC |
MS212103 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: BACKGROUND AND OBJECTIVE To develop a checklist of items measuring the quality of reports of r and omized clinical trials ( RCTs ) assessing nonpharmacological treatments ( NPTs ) . STUDY DESIGN AND SETTING The Delphi consensus method was used to select and reduce the number of items in the checklist . A total of 154 individuals were invited to participate : epidemiologists and statisticians involved in the field of methodology of RCTs ( n = 55 ) , members of the Cochrane Collaboration ( n = 41 ) , and clinicians involved in planning NPT clinical trials ( n = 58 ) . Participants ranked on a 10-point Likert scale whether an item should be included in the checklist . RESULTS Fifty-five experts ( 36 % ) participated in the survey . They were experienced in systematic review s ( 68 % were involved in the Cochrane Collaboration ) and in planning RCTs ( 76 % ) . Three rounds of the Delphi method were conducted to achieve consensus . The final checklist contains 10 items and 5 subitems , with items related to the st and ardization of the intervention , care provider influence , and additional measures to minimize the potential bias from lack of blinding of participants , care providers , and outcome assessors . CONCLUSIONS This tool can be used to critically appraise the medical literature , design NPT studies , and assess the quality of trial reports included in systematic review Study Design . A question naire was mailed to 3000 r and omly selected 35‐45‐year‐old individuals in three communities in central Sweden . Objectives . To study the 1‐year prevalence of spinal pain and its ramifications in the form of pain , function , sick leave , and health care use . Summary of Background Data . Previous research ers have used a variety of definitions and population s , but primarily have investigated the occurrence of pain . Comprehensive data are needed concerning health care use , the degree of the pain problem , functional disturbances , and sick leave . Method . Participants in the study completed a question naire regarding spinal pain during the past year including the degree of their experienced pain , functional impairment , lost work days , and health care use . Results . A total of 2305 people ( 78.5 % ) responded to the question naire . Nonrespondents had similar characteristics but a slightly lower 1‐year prevalence rate than did respondents . For respondents , the prevalence of spinal pain during the past year was 66.3 % , with women having a slightly higher prevalence than men . Approximately 25 % of the respondents indicated that they had a substantial problem based on ratings of pain , functional impairment , and sick leave . Work absenteeism reported to the Public Social Insurance Office involved 19 % of those with pain , but an additional 15 % indicated unreported absenteeism . On average , those with pain visited health care providers three times during the past year , but a small number of those who experienced pain consumed large amounts of health care and illness benefits . An important gender difference was shown , such that when pain was at its worst , men took sick leave , whereas women sought health care . Conclusions . Taken together , these data indicate that spinal pain is common among 35‐45‐year‐old men and ‐ women , and that it is related to marked problems for approximately one fourth of those who experience pain . Gender differences exist in the pattern of sick leave and health care use , and a small proportion of those with pain consume very large amounts of the re sources . Consequently , there is a need for early , effective , preventive treatments Background Current evidence on electrotherapies for the management of chronic neck pain is either lacking or conflicting . New therapeutic devices being introduced to the market should be investigated for their effectiveness and efficacy . The ENAR ® ( Electro Neuro Adaptive Regulator ) therapy device combines Western biofeedback with Eastern energy medicine . Methods A small , preliminary r and omised and controlled single-blinded trial was conducted on 24 participants ( ten males , 14 females ) between the ages of 18 to 50 years ( median age of 40.5 ) Consent was obtained and participants were r and omly allocated to one of three groups – ENAR , Transcutaneous Electrical Nerve Stimulation ( TENS ) , or control therapy – to test the hypothesis that ENAR therapy would result in superior pain reduction/disability and improvements in neck function compared with TENS or control intervention . The treatment regimen included twelve 15-minute treatment sessions over a six week period , followed by two assessment periods . Visual Analogue Scale ( VAS ) pain scores , Neck Disability Index ( NDI ) scores , Patient Specific Functional Scale ( PSFS ) scores and Short Form 36v1 ( SF-36 ) quality of life scores reported by participants were collected at each of the assessment s points throughout the trial ( 0 , 6 , 12 , 18 and 24 weeks ) . Results Eligible participants ( n = 30 ) were recruited and attended clinic visits for 6 months from the time of r and omisation . Final trial sample ( n = 24 ) comprised 9 within the ENAR group , 7 within the TENS group and 8 within the control group . With an overall study power of 0.92 , the ENAR group showed a decrease in mean pain score from measurement at time zero ( 5.0 ± 0.79 95%CI ) to the first follow-up measurement at six weeks ( 1.4 ± 0.83 95%CI ) . Improvement was maintained until week 24 ( 1.75 ± 0.9 95%CI ) . The TENS and control groups showed consistent pain levels throughout the trial ( 3.4 ± 0.96 95%CI and 4.1 ± 0.9 95%CI respectively ) . Wald analysis for pain intensity was significant for the ENAR group ( p = 0.01 ) . Six month NDI scores showed the disability level of the ENAR group ( 11.3 ± 4.5 95%CI ) was approximately half that of either the TENS ( 22.9 ± 4.8 95%CI ) or the control ( 29.4 ± 4.5 95%CI ) groups . NDI analysis using the Wald method , indicated significant reductions in disability only for the ENAR group ( p = 0.022 ) . PSFS results also demonstrated significantly better performance of ENAR ( p = 0.001 ) compared to both alternative interventions . Differential means analysis of the SF-36 results favoured ENAR for all of the subscales . Six of the initial 30 participants discontinued the trial protocol . Conclusion ENAR therapy participants reported a significant reduction in the intensity of neck pain ( VAS ) and disability ( NDI ) , as well as a significant increased function ( PSFS ) and overall quality of life ( SF-36 ) than TENS or control intervention participants . Due to the modest sample size and restricted cohort characteristics , future larger and more comprehensive trials are required to better evaluate the potential efficacy of the ENAR device in a more widely distributed sample population .Trial Registration This study has been registered with the Australian Clinical Trials Registry ( ACTR ) : ACTRN012606000438550 In the majority of patients with neck pain , symptoms will resolve spontaneously or quite quickly in response to therapy . However , some patients ' symptoms persist for a long period , irrespective of therapy . In this study , 20 patients with persistent ( greater than 8 weeks ) neck pain were enrolled in a double blind , placebo-controlled trial of low energy , pulsed electromagnetic therapy (PEMT)--a treatment previously shown to be effective in soft tissue injuries . For the first 3-week period , group A ( 10 patients ) received active PEMT units while group B ( 10 patients ) received facsimile placebo units . After 3 weeks , both pain ( visual analogue scale ( P less than .023 ) and range of movement ( P less than .002 ) had improved in the group on active treatment compared to the controls . After the second 3 weeks , during which both groups used active units , there were significant improvements in observed scores for pain and range of movement in both groups . PEMT , in the form described , can be used at home easily in the treatment of patients with neck pain . It is frequently successful and without side effects Successful treatment of torticollis with electromyographic ( EMG ) biofeedback has been reported in a number of single case and single group studies . The present investigation represents the first controlled outcome study . Twelve torticollis patients were r and omly assigned to EMG biofeedback or relaxation training and grade d neck exercises ( RGP ) . The procedure involved three sessions of baseline assessment , 15 sessions of EMG BF or RGP , 6 sessions of EMG BF or RGP plus home-management , 6 sessions of home-management alone , and follow-up 3 months after the end of treatment . A variety of outcome measures were used including physiological ( EMG from the two sternocleidomastoid muscles , skin conductance level ) , behavioral ( angle of head deviation , range of movement of the head ) , and self-report ( depression , functional disability , body concept ) , therapist and “ significant other ” reports and independent observer assessment of videos . In both groups , neck muscle activity was reduced from pre- to posttreatment . This reduction was greater in the EMG biofeedback group . There was evidence of feedback-specific neck muscle relaxation in the EMG biofeedback group . Therefore , the outcome was not due to nonspecific factors and could be attributed to feedback-specific effects . Changes in skin conductance level showed that neck muscle relaxation was not simply mediated by a general reduction of “ arousal . ” Significant improvements of extent of head deviation , and range of movement of the head , as well as reductions of depression were present , which were not different in the two groups . At the end of treatment , no patient was asymptomatic . Any therapeutic benefit was generally maintained at follow-up . The results and the procedural simplicity of RGP make the issue of cost-efficacy of EMG biofeedback a pertinent one . Further controlled outcome studies of EMG biofeedback treatment of torticollis with larger sample s are required Abstract The aim of this study was to evaluate the short , medium and long – term effects of peripheral repetitive magnetic stimulation ( rMS ) on myofascial pain compared with transcutaneous electrical nerve stimulation (TENS).Fifty – three subjects with myofascial trigger points ( TPs ) at the level of the superior trapezius muscle were allocated r and omly to three groups . The first group ( n = 17 ) was treated with rMS , the second ( n = 18 ) with TENS and the third ( n = 18 ) received a placebo treatment . Each treatment consisted of ten daily 20–minute sessions . Patients were evaluated before and immediately following treatment , and at one and three months after the end of treatment . Outcome measures were : the “ neck pain and disability visual analogue scale ” ( NPDVAS ) , an algometric evaluation of pain , an evaluation of the TP characteristics , and the range of cervical bending and rotation contralateral to the affected trapezius muscle . At the end of treatment , the rMS group showed a significant improvement in the NPDVAS , algometry , TP characteristics , and cervical contralateral rotation . This improvement also persisted at one and three months post – therapy . After treatment , the TENS group showed significant improvement in the same outcome measures except for algometry . At the one month follow – up visit , this improvement had returned to non significant levels in all outcome measures with the exception of NPDVAS.No significant effect of TENS was seen at the three – month follow – up visit . The placebo group showed no significant improvement in any measure . Our results strongly suggest that at medium and longer term intervals peripheral rMS may be more effective than TENS for the treatment of myofascial pain This study investigated effectiveness of manual therapy ( MT ) with transcutaneous electrical nerve stimulation ( TENS ) to reduce pain intensity in patients with mechanical neck disorder ( MND ) . A r and omized multi-centered controlled clinical trial was performed in 12 Primary Care Physiotherapy Units in Madrid Region . Ninety patients were included with diagnoses of subacute or chronic MND without neurological damage , 47 patients received MT and 43 TENS . The primary outcome was pain intensity measured in millimeters using the Visual Analogue Scale ( VAS ) . Also disability , quality of life , adverse effects and sociodemographic and prognosis variables were measured . Three evaluations were performed ( before , when the procedure finished and six months after ) . Seventy-one patients ( 79 % ) completed the follow-up measurement at six months . In more than half of the treated patients the procedure had a clinical ly relevant " short term " result after having ended the intervention , when either MT or TENS was used . The success rate decreased to one-third of the patients 6 months after the intervention . No differences can be found in the reduction of pain , in the decrease of disability nor in the quality of life between both therapies . Both analyzed physiotherapy techniques produce a short-term pain reduction that is clinical ly relevant OBJECTIVES To compare the efficacy of combined transcutaneous acupoint electrical stimulation ( TAES ) and electromagnetic millimeter wave ( EMMW ) therapy as an add-on treatment for pain relief and physical functional activity enhancement among adults with sub-acute non-specific spinal pain in either the low back or neck . DESIGN A non-blinded study with data obtained before , immediate , one week and three months after intervention . SETTING The Telehealth Clinic and Community Centre , Hong Kong . PARTICIPANTS Forty-seven subjects with either sub-acute neck or low back pain . INTERVENTION Subjects were r and omly allocated to either an intervention group ( n=23 ) or a control group ( n=24 ) . These groups were then divided into subgroups according to the site of their spinal pain-neck or back . The intervention group had eight treatments over a three-week period of TAES and EMMW . OUTCOME MEASURES Changes from baseline to the end of treatment were assessed at intervals of one week and three months on either neck or low back pain intensity [ by Visual Analogue Scale ( VAS ) ] ; stiffness level ; stress level ; neck or low back lateral flexion and forward flexion in cm , and interference with daily activities . RESULT
Output:
| Very low quality evidence determined that pulsed electromagnetic field therapy ( PEMF ) and repetitive magnetic stimulation ( rMS ) were more effective than placebo , while transcutaneous electrical nerve stimulation ( TENS ) showed inconsistent results .Very low quality evidence determined that PEMF , rMS and TENS were more effective than placebo .
We can not make any definite statements on the efficacy and clinical usefulness of electrotherapy modalities for neck pain .
Current evidence for PEMF , rMS , and TENS shows that these modalities might be more effective than placebo .
Galvanic current , iontophoresis , EMS , and a static magnetic field did not reduce pain or disability . |
MS212104 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: Background Pakistan has high maternal mortality , particularly in the rural areas . The delay in decision making to seek medical care during obstetric emergencies remains a significant factor in maternal mortality . Methods We present results from an experimental study in rural Pakistan . Village clusters were r and omly assigned to intervention and control arms ( 16 clusters each ) . In the intervention clusters , women were provided information on safe motherhood through pictorial booklets and audiocassettes ; traditional birth attendants were trained in clean delivery and recognition of obstetric and newborn complications ; and emergency transportation systems were set up . In eight of the 16 intervention clusters , husb and s also received specially design ed education material s on safe motherhood and family planning . Pre- and post-intervention surveys on selected maternal and neonatal health indicators were conducted in all 32 clusters . A district-wide survey was conducted two years after project completion to measure any residual impact of the interventions . Results Pregnant women in intervention clusters received prenatal care and prophylactic iron therapy more frequently than pregnant women in control clusters . Providing safe motherhood education to husb and s result ed in further improvement of some indicators . There was a small but significant increase in percent of hospital deliveries but no impact on the use of skilled birth attendants . Perinatal mortality reduced significantly in clusters where only wives received information and education in safe motherhood . The survey to assess residual impact showed similar results . Conclusions We conclude that providing safe motherhood education increased the probability of pregnant women having prenatal care and utilization of health services for obstetric complications Objectives : Community-based maternal and newborn intervention packages have been shown to reduce neonatal mortality in re source -constrained setting s. This analysis uses data from a large community-based cluster-r and omized trial to assess the impact of a community-based package on cause-specific neonatal mortality and draws programmatic and policy implication s. In addition , the study shows that cause-specific mortality estimates vary substantially based on the hierarchy used in assigning cause of death , which also has important implication s for program planning . Therefore , underst and ing the methods of assigning causes of deaths is important , as is the development of new method ologies that account for multiple causes of death . The objective of this study was to estimate the effect of two service delivery strategies ( home care and community care ) for a community-based package of maternal and neonatal health interventions on cause-specific neonatal mortality rates in a rural district of Bangladesh . Study design : Within the general community of the Sylhet district in rural northeast Bangladesh . Pregnancy histories were collected from a sample of women in the study area during the year preceding the study ( 2002 ) and from all women who reported a pregnancy outcome during the intervention in years 2004 to 2005 . All families that reported a neonatal death during these time periods were asked to complete a verbal autopsy interview . Expert algorithms with two different hierarchies were used to assign causes of neonatal death , varying in placement of the preterm/low birth weight category within the hierarchy ( either third or last ) . The main outcome measure was cause-specific neonatal mortality . Result : Deaths because of serious infections in the home-care arm declined from 13.6 deaths per 1000 live births during the baseline period to 7.2 during the intervention period according to the first hierarchy ( preterm placed third ) and from 23.6 to 10.6 according to the second hierarchy ( preterm placed last ) . Conclusion : This study confirms the high burden of neonatal deaths because of infection in low re source rural setting s like Bangladesh , where most births occur at home in the absence of skilled birth attendance and care seeking for newborn illnesses is low . The study demonstrates that a package of community-based neonatal health interventions , focusing primarily on infection prevention and management , can substantially reduce infection-related neonatal mortality Background To evaluate a delivery strategy for newborn interventions in rural Bangladesh . Methods A cluster-r and omized controlled trial was conducted in Mirzapur , Bangladesh . Twelve unions were r and omized to intervention or comparison arm . All women of reproductive age were eligible to participate . In the intervention arm , community health workers identified pregnant women ; made two antenatal home visits to promote birth and newborn care preparedness ; made four postnatal home visits to negotiate preventive care practice s and to assess newborns for illness ; and referred sick neonates to a hospital and facilitated compliance . Primary outcome measures were antenatal and immediate newborn care behaviours , knowledge of danger signs , care seeking for neonatal complications , and neonatal mortality . Findings A total of 4616 and 5241 live births were recorded from 9987 and 11153 participants in the intervention and comparison arm , respectively . High coverage of antenatal ( 91 % visited twice ) and postnatal ( 69 % visited on days 0 or 1 ) home visitations was achieved . Indicators of care practice s and knowledge of maternal and neonatal danger signs improved . Adjusted mortality hazard ratio in the intervention arm , compared to the comparison arm , was 1.02 ( 95 % CI : 0.80–1.30 ) at baseline and 0.87 ( 95 % CI : 0.68–1.12 ) at endline . Primary causes of death were birth asphyxia ( 49 % ) and prematurity ( 26 % ) . No adverse events associated with interventions were reported . Conclusion Lack of evidence for mortality impact despite high program coverage and quality assurance of implementation , and improvements in targeted newborn care practice s suggests the intervention did not adequately address risk factors for mortality . The level and cause-structure of neonatal mortality in the local population must be considered in developing interventions . Programs must ensure skilled care during childbirth , including management of birth asphyxia and prematurity , and curative postnatal care during the first two days of life , in addition to essential newborn care and infection prevention and management . Trial Registration Clinical trials.gov BACKGROUND Neonatal deaths in developing countries make the largest contribution to global mortality in children younger than 5 years . 90 % of deliveries in the poorest quintile of households happen at home . We postulated that a community-based participatory intervention could significantly reduce neonatal mortality rates . METHODS We pair-matched 42 geopolitical clusters in Makwanpur district , Nepal , selected 12 pairs r and omly , and r and omly assigned one of each pair to intervention or control . In each intervention cluster ( average population 7000 ) , a female facilitator convened nine women 's group meetings every month . The facilitator supported groups through an action-learning cycle in which they identified local perinatal problems and formulated strategies to address them . We monitored birth outcomes in a cohort of 28?931 women , of whom 8 % joined the groups . The primary outcome was neonatal mortality rate . Other outcomes included stillbirths and maternal deaths , uptake of antenatal and delivery services , home care practice s , infant morbidity , and health-care seeking . Analysis was by intention to treat . The study is registered as an International St and ard R and omised Controlled Trial , number IS RCT N31137309 . FINDINGS From 2001 to 2003 , the neonatal mortality rate was 26.2 per 1000 ( 76 deaths per 2899 livebirths ) in intervention clusters compared with 36.9 per 1000 ( 119 deaths per 3226 livebirths ) in controls ( adjusted odds ratio 0.70 [ 95 % CI 0.53 - 0.94 ] ) . Stillbirth rates were similar in both groups . The maternal mortality ratio was 69 per 100000 ( two deaths per 2899 livebirths ) in intervention clusters compared with 341 per 100000 ( 11 deaths per 3226 livebirths ) in control clusters ( 0.22 [ 0.05 - 0.90 ] ) . Women in intervention clusters were more likely to have antenatal care , institutional delivery , trained birth attendance , and hygienic care than were controls . INTERPRETATION Birth outcomes in a poor rural population improved greatly through a low cost , potentially sustainable and scalable , participatory intervention with women 's groups BACKGROUND Two recent trials have shown that women 's groups can reduce neonatal mortality in poor communities . We assessed the effectiveness of a scaled-up development programme with women 's groups to address maternal and neonatal care in three rural districts of Bangladesh . METHODS 18 clusters ( with a mean population of 27 953 [ SD 5953 ] ) in three districts were r and omly assigned to either intervention or control ( nine clusters each ) by use of stratified r and omisation . For each district , cluster names were written on pieces of paper , which were folded and placed in a bottle . The first three cluster names drawn from the bottle were allocated to the intervention group and the remaining three to control . All clusters received health services strengthening and basic training of traditional birth attendants . In intervention clusters , a facilitator convened 18 groups every month to support participatory action and learning for women , and to develop and implement strategies to address maternal and neonatal health problems . Women were eligible to participate if they were aged 15 - 49 years , residing in the project area , and had given birth during the study period ( Feb 1 , 2005 , to Dec 31 , 2007 ) . Neither study investigators nor participants were masked to treatment assignment . In a population of 229 195 people ( intervention clusters only ) , 162 women 's groups provided coverage of one group per 1414 population . The primary outcome was neonatal mortality rate ( NMR ) . Analysis was by intention to treat . This trial is registered as an International St and ard R and omised Controlled Trial , number IS RCT N54792066 . FINDINGS We monitored outcomes for 36 113 births ( intervention clusters , n=17 514 ; control clusters , n=18 599 ) in a population of 503 163 over 3 years . From 2005 to 2007 , there were 570 neonatal deaths in the intervention clusters and 656 in the control clusters . Cluster-level mean NMR ( adjusted for stratification and clustering ) was 33.9 deaths per 1000 livebirths in the intervention clusters compared with 36.5 per 1000 in the control clusters ( risk ratio 0.93 , 95 % CI 0.80 - 1.09 ) . INTERPRETATION For participatory women 's groups to have a significant effect on neonatal mortality in rural Bangladesh , detailed attention to programme design and context ual factors , enhanced population coverage , and increased enrolment of newly pregnant women might be needed . FUNDING Women and Children First , the UK Big Lottery Fund , Saving Newborn Lives , and the UK Department for International Development IMPORTANCE Community-based interventions can reduce neonatal mortality when health systems are weak . Population coverage of target groups may be an important determinant of their effect on behavior and mortality . A women 's group trial at coverage of 1 group per 1414 population in rural Bangladesh showed no effect on neonatal mortality , despite a similar intervention having a significant effect on neonatal and maternal death in comparable setting s. OBJECTIVE To assess the effect of a participatory women 's group intervention with higher population coverage on neonatal mortality in Bangladesh . DESIGN A cluster r and omized controlled trial in 9 intervention and 9 control clusters . SETTING Rural Bangladesh . PARTICIPANTS Women permanently residing in 18 unions in 3 districts and accounting for 19 301 births during the final 24 months of the intervention . INTERVENTIONS Women 's groups at a coverage of 1 per 309 population that proceed through a participatory learning and action cycle in which they prioritize issues that affected maternal and neonatal health and design and implement strategies to address these issues . MAIN OUTCOMES AND MEASURES Neonatal mortality rate . RESULTS Analysis included 19 301 births during the final 24 months of the intervention . More than one-third of newly pregnant women joined the groups . The neonatal mortality rate was significantly lower in the intervention arm ( 21.3 neonatal deaths per 1000 live births vs 30.1 per 1000 in control areas ) , a reduction in neonatal mortality of 38 % ( risk ratio , 0.62 [ 95 % CI , 0.43 - 0.89 ] ) when adjusted for socioeconomic factors . The cost-effectiveness was US $ 220 to $ 393 per year of life lost averted . Cause-specific mortality rates suggest reduced deaths due to infections and those associated with prematurity/low birth weight . Improvements were seen in hygienic home delivery practice s , newborn thermal care , and breastfeeding practice s. CONCLUSIONS AND RELEVANCE Women 's group community mobilization , delivered at adequate population coverage , is a highly cost-effective approach to improve newborn survival and health behavior indicators in rural Bangladesh . TRIAL REGISTRATION is rct n.org Identifier : IS RCT N01805825 Background Public health interventions are increasingly evaluated using cluster-r and omised trials in which groups rather than individuals are allocated r and omly to treatment and control arms . Outcomes for individuals within the same cluster are often more correlated than outcomes for individuals in different clusters . This needs to be taken into account in sample size estimations for planned trials , but most estimates of intracluster correlation for perinatal health outcomes come from hospital-based studies and may therefore not reflect outcomes in the community . In this study we report estimates for perinatal health outcomes from community-based trials to help research ers plan future evaluations . Methods We estimated the intracluster correlation and the coefficient of variation for
Output:
| Conclusion Women ’s education interventions may improve the number of women seeking birth at a health care facility , but the evidence is of low quality . |
MS212105 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: OBJECTIVES To investigate the effectiveness of snoezelen , integrated in 24-hour daily care , on the behavior and mood of demented nursing home residents . DESIGN Quasiexperimental pre- and posttest design . SETTING Twelve psychogeriatric wards of six nursing homes , spread over different parts of the Netherl and s. PARTICIPANTS One hundred twenty-five patients with moderate to severe dementia and care dependency were included in the pretest and 128 in the posttest ; 61 were completers ( included in both pre- and posttest ) . INTERVENTION Experimental subjects received an individual 24-hour snoezel program , based on family history taking and stimulus preference screening . Caregivers were trained , and ( organizational ) adaptations were made to fulfill the conditions for resident-oriented snoezel care . The control group received usual nursing home care . MEASUREMENTS Observations were made on the wards using subscales of the Dutch Behavior Observation Scale for Psychogeriatric In patients , the Dutch version of the Cohen-Mansfield Agitation Inventory , and the Cornell Scale for Depression in Dementia . Independent assessors observed video recordings of morning care and rated residents ' behavior and mood using INTERACT and FACE , respectively . RESULTS Residents receiving snoezel care demonstrated a significant treatment effect with respect to their level of apathetic behavior , loss of decorum , rebellious behavior , aggressive behavior , and depression . During morning care , the experimental subjects showed significant changes in well-being ( mood , happiness , enjoyment , sadness ) and adaptive behavior ( responding to speaking , relating to caregiver , normal-length sentences ) . CONCLUSION Snoezel care particularly seems to have a positive effect on disturbing and withdrawn behavior . The results suggest that a 24-hour integrated snoezel program has a generalizing effect on the mood and behavior of demented residents Long-term effects of multisensory stimulation were assessed using a “ Snoezelen ” room on older residents with dementia . Thirty patients were r and omly assigned to 3 groups : multisensory stimulation environment ( MSSE ) group , individualized activities ( activity ) group , and control group . The MSSE and activity groups participated in two 30-minute weekly individualized intervention sessions over 16 weeks . Pre- , mid- , posttrial , and 8-week follow-up behavior , mood , cognitive , and functional impairment in basic activities of daily living were registered . Items included in the physically nonaggressive behavior factor improved significantly in post- versus pretrial in the MSSE group compared to the activity group , with no significant differences between MSSE and control groups . The MSSE and activity groups demonstrated behavior improvements and higher scores on the Cohen-Mansfield agitation inventory , verbal agitated behavior factor , and Neuropsychiatric Inventory – Nursing Home , with no significant differences between groups . The MSSE could have long-term positive effects on such neuropsychiatric symptoms in older people with dementia OBJECTIVES Dementia is the disease most frequently leading to admission in long-term care institutions , primarily because persons with this disease exhibit several behavioral problems . The objective of this study was to measure the efficacy of the sensory integration program developed by Ross and Burdick in improving the functioning of persons with dementia . METHOD Forty subjects with dementia ( 28 women , 12 men , mean age of 78.4 years ) in three different institutional setting s in Quebec City , Canada , were r and omly assigned to the study ( n = 22 ) or control ( n = 18 ) group . Subjects in the study group participated in three 45-min sessions of a sensory integration program per week for 10 weeks . Outcomes were measured using the Revised Memory and Behavior Problems Checklist and the Psychogeriatric Scale of Basic Activities of Daily Living . RESULTS The sensory integration program had no significant effect on the behaviors of the study group . CONCLUSION Before this type of program is labeled inefficacious , other studies are necessary to determine whether modifying the frequency of sessions , the number of subjects , and the measuring instruments would lead to similar results BACKGROUND Music therapy is a potential non-pharmacological treatment for the behavioral and psychological symptoms of dementia , but although some studies have found it to be helpful , most are small and uncontrolled . METHODS This case-control study was carried out by qualified music therapists in two nursing homes and two psychogeriatric wards . The participants were 38 patients with moderate or severe Alzheimer 's disease ( AD ) assigned r and omly to a music therapy group and a control group . RESULTS The study showed a significant reduction in activity disturbances in the music therapy group during a 6-week period measured with the Behavior Pathology in Alzheimer 's Disease Rating Scale ( BEHAVE-AD ) . There was also a significant reduction in the sum of scores of activity disturbances , aggressiveness and anxiety . Other symptoms rated by subscales of the BEHAVE-AD did not decrease significantly . Four weeks later the effects had mostly disappeared . CONCLUSIONS Music therapy is a safe and effective method for treating agitation and anxiety in moderately severe and severe AD . This is in line with the results of some non-controlled studies on music therapy in dementia BACKGROUND Over recent years multi-sensory stimulation ( MSS ) has become an increasingly popular approach to care and is used in several centres throughout Europe . This popularity could be explained by the limited alternatives available to staff and a widely held belief that MSS is a friendly and highly humane approach . A r and omized controlled trial was therefore essential to evaluate the effectiveness and extent of the benefits of MSS . AIM To assess whether MSS is more effective in changing the behaviour , mood and cognition of older adults with dementia than a control of activity ( playing card games , looking at photographs , doing quizzes , etc . ) . METHODS A total of 136 patients from three countries [ United Kingdom ( UK ) , the Netherl and s and Sweden ] were r and omized to MSS or activity groups . Patients participated in eight 30-minute sessions over 4 weeks . Ratings of behaviour and mood were taken before , during and after sessions to investigate immediate effects . Pre- , mid- , post-trial and follow-up assessment s were taken to investigate any generalization of effects to cognition and behaviour and mood at home/on the ward or at the day hospital . RESULTS There were limited short-term improvements for both the MSS and activity groups immediately after sessions , and limited short-term improvements between the groups during sessions . There were no significant differences between the groups when assessing change in behaviour , mood or cognition at home/on the ward or at the day hospital . In the UK , however , behaviour at the day hospital for both groups remained stable during the trial but deteriorated once the sessions had stopped , and active/disturbed behaviour at home improved but likewise deteriorated once sessions had stopped . CONCLUSIONS Overall , MSS was found to be no more effective than an activity in changing the behaviour , mood or cognition of patients with dementia in the short- or long-term This study investigates the effects of emotion‐oriented care on the behavior of elderly people with cognitive impairment and behavioral problems . This approach is mainly based on the validation approach , but also uses insights from other approaches like reminiscence and sensory stimulation OBJECTIVES To test the effects of an intervention that helps families manage distressing behaviors in family members with dementia . DESIGN Two-group r and omized trial . SETTING In home . PARTICIPANTS Two hundred seventy-two caregivers and people with dementia . INTERVENTION Up to 11 home and telephone contacts over 16 weeks by health professionals who identified potential triggers of patient behaviors , including communication and environmental factors and patient undiagnosed medical conditions ( by obtaining blood and urine sample s ) and trained caregivers in strategies to modify triggers and reduce their upset . Between 16 and 24 weeks , three telephone contacts reinforced strategy use . MEASUREMENTS Primary outcomes were frequency of targeted problem behavior and caregiver upset with and confidence managing it at 16 weeks . Secondary outcomes were caregiver well-being and management skills at 16 and 24 weeks and caregiver perceived benefits . Prevalence of medical conditions for intervention patients were also examined . RESULTS At 16 weeks , 67.5 % of intervention caregivers reported improvement in targeted problem behavior , compared with 45.8 % of caregivers in a no-treatment control group ( P=.002 ) , and reduced upset with ( P=.03 ) and enhanced confidence managing ( P=.01 ) the behavior . Additionally , intervention caregivers reported less upset with all problem behaviors ( P=.001 ) , less negative communication ( P=.02 ) , less burden ( P=.05 ) , and better well-being ( P=.001 ) than controls . Fewer intervention caregivers had depressive symptoms ( 53.0 % ) than control group caregivers ( 67.8 % , P=.02 ) . Similar caregiver outcomes occurred at 24 weeks . Intervention caregivers perceived more study benefits ( P<.05 ) , including ability to keep family members home , than controls . Blood and urine sample s of intervention patients with dementia showed that 40 ( 34.1 % ) had undiagnosed illnesses requiring physician follow-up . CONCLUSION Targeting behaviors up setting to caregivers and modifying potential triggers improves symptomatology in people with dementia and caregiver well-being and skills The purpose of this pilot study was to explore the feasibility and effectiveness of using multisensory environments ( MSE ) in the home of people with dementia . A qualitative research design was used , which included semi-structured interviews and self-rated caregiver observation checklists . Field notes and audio recorded interviews were transcribed for data analysis . Data were reduced and coded for theme identification . Positive and negative effects of the use of MSE in the home on the behaviors of the person with dementia , caregiver burden , and family interpersonal relationships were revealed . Overall , MSE was discovered to promote a relaxing and calm environment in the home , which helped the person with dementia attend more to their immediate surroundings , and to improve family interactions . Although the majority of caregivers reported they enjoyed the MSE , they acknowledged their disappointment in the MSE as not providing more caregiver respite The objective of this study was to compare the effects of a multisensory stimulation environment ( MSSE ) and individualized music sessions on agitation , emotional and cognitive status , and dementia severity in a sample of institutionalized patients with severe dementia . Twenty-two participants with a diagnosis of severe or very severe dementia were r and omly assigned to two groups : MSSE and individualized music sessions . Both groups participated in two 30-min weekly sessions over 16 weeks . Outcomes were agitation ( Cohen-Mansfield Agitation Inventory , CMAI ) , mood ( Cornell Scale for Depression in Dementia , CSDD ) , anxiety ( Rating Anxiety in Dementia , RAID ) , cognitive function ( Severe Mini-Mental State Examination , SMMSE ) , and the overall severity of dementia ( Bedford Alzheimer Nursing Severity Scale , BANS-S ) . They were assessed at baseline ( pre-trial ) , in the middle ( mid-trial ) , at the end of the intervention ( post-trial ) , and 8 weeks after the intervention ( follow-up ) . Patients in the MSSE group showed significant improvement in their RAID and BANS-S scores compared with the individualized music group post- versus pre-trial . With regard to agitation , there was improvement during the intervention in both the MSSE and individualized music groups in the CMAI total score after 16 weeks of intervention , with no significant differences between the groups . The results suggest that MSSE could have better effects on anxiety symptoms and dementia severity in comparison with individualized music sessions in elderly patients with severe dementia OBJECTIVES To investigate the effects of lavender olfactory stimulation intervention on fall incidence in elderly nursing home residents . DESIGN R and omized placebo-controlled trial . SETTING Three r and omly selected nursing homes in northern Japan . PARTICIPANTS One hundred and forty-five nursing home residents aged 65 and older . INTERVENTION Participants were r and omly assigned to the lavender ( n = 73 ) or placebo group ( n = 72 ) for a 360-day study period . The lavender group received continuous olfactory stimulation from a lavender patch . The placebo group received an unscented patch . MEASUREMENT The primary outcome measure was resident falls . Other measurements taken at baseline and 12 months included functional ability ( assessed using the Barthel Index ) , cognitive function ( Mini-Mental State Examination ( MMSE ) ) , and behavioral and psychological problems associated with dementia ( Cohen-Mansfield Agitation Inventory ( CMAI ) ) . RESULTS There were fewer fallers in the lavender group ( n = 26 ) than in the placebo group ( n = 36 ) ( hazard ratio (HR)=0.57 , 95 % confidence interval ( CI ) = 0.34 - 0.95 ) and a lower incidence rate in the lavender group ( 1.04 per person-year ) than in the placebo group ( 1.40 per person-year ) ( incidence rate ratio = 0.51 , 95 % CI = 0.30 - 0.88 ) . The lavender group also had a significant decrease in CMAI score ( P = .04 ) from baseline to follow-up in a per protocol analysis . CONCLUSION Lavender olfactory stimulation may reduce falls and agitation in elderly nursing home residents ; further research is necessary to confirm these findings Objective : To investigate whether behavioural , motor and physiological responses of individuals with Huntington 's disease ( HD ) to a controlled multisensory environment ( MSE ) are effective as a therapeutic ( sustained effects ) or leisure ( immediate effects ) activity . Design : Pilot study – a r and omized , controlled , two-group design . Setting : Specialist residential unit for people with mid-late stage HD . Subjects : Twelve patients with HD ( one subject from each
Output:
| However , these effects did not always persist in the long-term .
Conclusions : These findings suggest that multisensory stimulation could be an effective intervention for managing NPS in older adults with major NCD in a mild to severe stage , particularly for managing behavioral symptoms such as agitation .
This research provides an indication of the likely effect of the multisensory stimulation on NPS such as agitation and anxiety , as well on cognitive status |
MS212106 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Background —This study evaluated the hypothesis that transendocardial injections of autologous mononuclear bone marrow cells in patients with end-stage ischemic heart disease could safely promote neovascularization and improve perfusion and myocardial contractility . Methods and Results —Twenty-one patients were enrolled in this prospect i ve , nonr and omized , open-label study ( first 14 patients , treatment ; last 7 patients , control ) . Baseline evaluations included complete clinical and laboratory evaluations , exercise stress ( ramp treadmill ) , 2D Doppler echocardiogram , single-photon emission computed tomography perfusion scan , and 24-hour Holter monitoring . Bone marrow mononuclear cells were harvested , isolated , washed , and resuspended in saline for injection by NOGA catheter ( 15 injections of 0.2 cc ) . Electromechanical mapping was used to identify viable myocardium ( unipolar voltage ≥6.9 mV ) for treatment . Treated and control patients underwent 2-month noninvasive follow-up , and treated patients alone underwent a 4-month invasive follow-up according to st and ard protocol s and with the same procedures used as at baseline . Patient population demographics and exercise test variables did not differ significantly between the treatment and control groups ; only serum creatinine and brain natriuretic peptide levels varied in laboratory evaluations at follow-up , being relatively higher in control patients . At 2 months , there was a significant reduction in total reversible defect and improvement in global left ventricular function within the treatment group and between the treatment and control groups ( P = 0.02 ) on quantitative single-photon emission computed tomography analysis . At 4 months , there was improvement in ejection fraction from a baseline of 20 % to 29 % ( P = 0.003 ) and a reduction in end-systolic volume ( P = 0.03 ) in the treated patients . Electromechanical mapping revealed significant mechanical improvement of the injected segments ( P < 0.0005 ) at 4 months after treatment . Conclusions —Thus , the present study demonstrates the relative safety of intramyocardial injections of bone marrow – derived stem cells in humans with severe heart failure and the potential for improving myocardial blood flow with associated enhancement of regional and global left ventricular function AIMS Despite accumulated evidence that intracoronary bone marrow cell ( BMC ) therapy may be beneficial in acute myocardial infa rct ion , there are only limited data available on the effectiveness of BMC 's in chronic heart failure . The aim of this study was to quantitatively investigate ventricular haemodynamics , geometry , and contractility as well as the long-term clinical outcome of BMC treated patients with reduced left ventricular ejection fraction ( LVEF ) due to chronic ischaemic cardiomyopathy . METHODS AND RESULTS Patients with chronic heart failure ( n = 391 LVEF < or=35 % ) due to ischaemic cardiomyopathy were enrolled in the present study . Of these , 191 patients ( mean NYHA class 3.22 ) underwent intracoronary BMC therapy . The control group ( mean NYHA class 3.06 ) consisted of 200 patients with comparable LVEF . Assessment s of haemodynamics at rest and exercise , quantitative ventriculography , spiroergometry , 24 h Holter ECG , late potentials , and heart rate variability were analysed . Over 3 months to 5 years after intracoronary BMC therapy there was a significant improvement in haemodynamics ( e.g. LVEF , cardiac index ) , exercise capacity , oxygen uptake , and LV contractility . Importantly , there was a significant decrease in long-term mortality in the BMC treated patients compared with the control group . CONCLUSION Intracoronary BMC therapy improves ventricular performance , quality of life and survival in patients with heart failure . These effects were present when BMC were administered in addition to st and ard therapeutic regimes . No side effects were observed OBJECTIVES This study sought to evaluate the feasibility and safety of autologous bone marrow-derived and cardiogenically oriented mesenchymal stem cell therapy and to probe for signs of efficacy in patients with chronic heart failure . BACKGROUND In pre- clinical heart failure models , cardiopoietic stem cell therapy improves left ventricular function and blunts pathological remodeling . METHODS The C-CURE ( Cardiopoietic stem Cell therapy in heart failURE ) trial , a prospect i ve , multicenter , r and omized trial , was conducted in patients with heart failure of ischemic origin who received st and ard of care or st and ard of care plus lineage-specified stem cells . In the cell therapy arm , bone marrow was harvested and isolated mesenchymal stem cells were exposed to a cardiogenic cocktail . Derived cardiopoietic stem cells , meeting release criteria under Good Manufacturing Practice , were delivered by endomyocardial injections guided by left ventricular electromechanical mapping . Data acquisition and analysis were performed in blinded fashion . The primary endpoint was feasibility/safety at 2-year follow-up . Secondary endpoints included cardiac structure/function and measures of global clinical performance 6 months post-therapy . RESULTS Mesenchymal stem cell cocktail-based priming was achieved for each patient with the dose attained in 75 % and delivery without complications in 100 % of cases . There was no evidence of increased cardiac or systemic toxicity induced by cardiopoietic cell therapy . Left ventricular ejection fraction was improved by cell therapy ( from 27.5 ± 1.0 % to 34.5 ± 1.1 % ) versus st and ard of care alone ( from 27.8 ± 2.0 % to 28.0 ± 1.8 % , p < 0.0001 ) and was associated with a reduction in left ventricular end-systolic volume ( -24.8 ± 3.0 ml vs. -8.8 ± 3.9 ml , p < 0.001 ) . Cell therapy also improved the 6-min walk distance ( + 62 ± 18 m vs. -15 ± 20 m , p < 0.01 ) and provided a superior composite clinical score encompassing cardiac parameters in t and em with New York Heart Association functional class , quality of life , physical performance , hospitalization , and event-free survival . CONCLUSIONS The C-CURE trial implements the paradigm of lineage guidance in cell therapy . Cardiopoietic stem cell therapy was found feasible and safe with signs of benefit in chronic heart failure , meriting definitive clinical evaluation . ( C-Cure Clinical Trial ; NCT00810238 ) BACKGROUND Autologous adult stem cell transplantation has been touted as the latest tool in regenerative medical therapy . Its potential for use in cardiovascular disease has only recently been recognized . A r and omized study was conducted with a novel epicardial technique to deploy stem cells as an adjuvant to conventional revascularization therapy in patients with congestive heart failure . METHODS After institutional review board and government approval , adult autologous stem cell transplantation ( CD34 + ) was performed in patients with ischemic cardiomyopathy and an ejection fraction of less than 35 % who were scheduled for primary off-pump coronary artery bypass grafting . Preoperatively , the patients underwent echocardiography , stress thallium imaging single photon emission computed tomography , and cardiac catheterization to identify ischemic regions of the heart and to guide in the selection of stem cell injection sites . The patients were prospect ively r and omized before the operative therapy was performed . Patient follow-up was 1 , 3 , and 6 months with echocardiography , single photon emission computed tomography , and angiography . RESULTS There were 20 patients enrolled in the study . Ten patients had successful subepicardial transplantation of autologous stem cells into ischemic myocardium . The other 10 patients , the control group , only had off-pump coronary artery bypass grafting . There were 8 male and 2 female subjects in each group . The median number of grafts performed was 1 in both groups . On angiographic follow-up , all grafts were patent at 6 months . The ejection fractions of the off-pump coronary artery bypass grafting group versus the off-pump coronary artery bypass grafting plus stem cell transplantation group were as follows : preoperative , 30.7 % + /- 2.5 % versus 29.4 % + /- 3.6 % ; 1 month , 36.4 % + /- 2.6 % versus 42.1 % + /- 3.5 % ; 3 months , 36.5 % + /- 3.0 % versus 45.5 % + /- 2.2 % ; and 6 months , 37.2 % + /- 3.4 % versus 46.1 % + /- 1.9 % ( P < .001 ) . There were no perioperative arrhythmias or neurologic or ischemic myocardial events in either group . CONCLUSIONS Autologous stem cell transplantation led to significant improvement in cardiac function in patients undergoing off-pump coronary artery bypass grafting for ischemic cardiomyopathy . Further investigation is required to quantify the optimal timing and specific cellular effects of the therapy OBJECTIVES The graft of stem cells to treat ischemic cardiomyopathy is popular in many clinical trials . The aim of this study was to evaluate the effectiveness of isolated coronary artery bypass graft combined with bone marrow mononuclear cells ( BMMNC ) delivered through graft vessels to improve left ventricular function of patients with previous myocardial infa rct ion and chronic heart failure using echocardiography . METHODS Forty-two patients with previous myocardial infa rct ion and chronic heart failure were r and omly allocated to one of the two groups : CABG only ( 18 in CABG group ) , or CABG with BMMNC transplantation ( 24 in CABG + BMMNC group ) . Echocardiographic parameters of systolic function were measured on B-mode imaging , tissue Doppler imaging ( TDI ) , two-dimensional ( 2D ) strain imaging , and 8 parameters were measured totally . Echocardiographic parameters of diastolic function were measured on pulsed-wave Doppler imaging , TDI , and 2D strain rate imaging ; 17 parameters were measured totally . RESULTS Postoperative left ventricular ejection fraction ( LVEF ) versus preoperative LVEF were 49.083 ± 1.914 % versus 36.042 ± 1.185 % ( P < 0.05 ) in CABG + BMMMNC group and 41.389 ± 2.210 % versus 34.667 ± 1.369 % ( P < 0.05 ) in CABG group , global longitudinal strain were -12.542 ± 0.512 % versus -7.083 ± 0.583 % ( P < 0.05 ) in CABG + BMMMNC group and -9.278 ± 0.591 % versus -7.000 ± 0.673 % ( P < 0.05 ) in CABG group , mLsr1 were -0.108 ± 0.018/sec versus -0.039 ± 0.017/sec ( P < 0.05 ) in CABG+BMMMNC group and -0.048 ± 0.021/sec versus 0.004 ± 0.020/sec ( P < 0.05 ) in CABG group , mLsr2 were -0.055 ± 0.013/sec versus -0.009 ± 0.015/sec ( P < 0.05 ) in CABG + BMMMNC group and 0.004 ± 0.015/sec versus 0.024 ± 0.017/sec ( P < 0.05 ) in CABG group , and Aa1 were 7.303 ± 0.479 cm/sec versus 5.131 ± 0.381 cm/sec ( P < 0.05 ) in CABG + BMMMNC group and 7.908 ± 0.553 cm/sec versus 6.764 ± 0.440 cm/sec ( P < 0.05 ) in CABG group . Parameters above were significantly improved postoperatively in both groups . The degree of the improvement was significantly different between the two groups with the CABG + BMMNC group improved more versus the group of CABG only ( P < 0.05 ) . CONCLUSIONS The improvement of left ventricular function in CABG + BMMNC group is better than CABG group . 2D strain and strain rate imaging is a more sensitive tool to evaluate left ventricular function OBJECTIVES This study aim ed at examining the efficacy of bone marrow mononuclear cell ( BMMNC ) delivery through graft vessel for patients with a previous myocardial infa rct ion ( MI ) and chronic heart failure during coronary artery bypass graft ( CABG ) . BACKGROUND Little evidence exists supporting the practice of BMMNC delivery through graft vessel for patients with a previous MI and chronic heart failure during CABG . METHODS From November 2006 to June 2009 , a r and omized , placebo-controlled trial was conducted to test the efficacy and safety of CABG for multivessel coron
Output:
| This meta- analysis suggests that SCT may contribute to the improvement of LVEF , as well as the reduction of the NYHA class , CCS grade , and LVESV .
In addition , SCT does not affect mortality |
MS212107 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Following the demonstration that increased prostagl and in F2 alpha production causes pain similar to dysmenorrhea , and the finding that prostagl and in synthetase inhibitors are capable of relieving menstrual pain , the early theory of uterine ischemia has once again gained support as the most likely explanation for this condition . In a double-blind , placebo-controlled , crossover study , 30 of 43 women with moderate to severe dysmenorrhea who completed the trial preferred flurbiprofen ( Ansaid , Upjohn ) , a potent new analgesic/anti-inflammatory agent ( 50 mg four times daily ) , to aspirin ( 650 mg four times daily ) and placebo . Flurbiprofen was also rated superior to aspirin and placebo in the degree of pain relief . An algorithm for the diagnosis and treatment of 90 percent of women with primary dysmenorrhea is presented The purpose of the present investigation was to compare the analgesic efficacy of flurbiprofen , a nonsteroidal anti-inflammatory drug , which is a phenyl propionic acid derivative , with acetaminophen and placebo in 63 adult out patients with moderate to severe dental pain following periodontal surgery . After surgery was completed under local anesthesia , the patients received under double-blind conditions an envelope containing four tablets of either flurbiprofen 100 mg , acetaminophen 500 mg , or placebo and they were instructed to take one tablet every 6 hours when postoperative pain reached moderate to severe intensity . To determine analgesic efficacy and patients recorded pain intensity on a scale of 0 to 3 . Patients were allowed to remedicate after 1 hour if pain was not reduced . Flurbiprofen was shown to possess an adequate analgesic effect superior to either placebo ( P less than 0.005 ) or acetaminophen ( P less than 0.01 ) in the parameters studied . Our results seem to further support earlier data obtained with the drug in dental patients with postoperative pain after the surgical removal of impacted third molars ; therefore , it is concluded that flurbiprofen used as directed is a new alternative for the proper treatment of pain following periodontal surgery Abstract Variability in patients ' response to interventions in pain and other clinical setting s is large . Many explanations such as trial methods , environment or culture have been proposed , but this paper sets out to show that the main cause of the variability may be r and om chance , and that if trials are small their estimate of magnitude of effect may be incorrect , simply because of the r and om play of chance . This is highly relevant to the questions of ‘ How large do trials have to be for statistical accuracy ? ’ and ‘ How large do trials have to be for their results to be clinical ly valid ? ’ The true underlying control event rate ( CER ) and experimental event rate ( EER ) were determined from single‐dose acute pain analgesic trials in over 5000 patients . Trial group size required to obtain statistically significant and clinical ly relevant ( 0.95 probability of number‐needed‐to‐treat within ±0.5 of its true value ) results were computed using these values . Ten thous and trials using these CER and EER values were simulated using varying group sizes to investigate the variation due to r and om chance alone . Most common analgesics have EERs in the range 0.4–0.6 and CER of about 0.19 . With such efficacy , to have a 90 % chance of obtaining a statistically significant result in the correct direction requires group sizes in the range 30–60 . For clinical relevance nearly 500 patients are required in each group . Only with an extremely effective drug ( EER>0.8 ) will we be reasonably sure of obtaining a clinical ly relevant NNT with commonly used group sizes of around 40 patients per treatment arm . The simulated trials showed substantial variation in CER and EER , with the probability of obtaining the correct values improving as group size increased . We contend that much of the variability in control and experimental event rates is due to r and om chance alone . Single small trials are unlikely to be correct . If we want to be sure of getting correct ( clinical ly relevant ) results in clinical trials we must study more patients . Credible estimates of clinical efficacy are only likely to come from large trials or from pooling multiple trials of conventional ( small ) size & NA ; There is uncertainty over whether the patient group in which acute pain studies are conducted ( pain model ) has any influence on the estimate of analgesic efficacy . Data from four recently up date d systematic review s of aspirin 600/650 mg , paracetamol 600/650 mg , paracetamol 1000 mg and ibuprofen 400 mg were used to investigate the influence of pain model . Area under the pain relief versus time curve equivalent to at least 50 % maximum pain relief over 6 h was used as the outcome measure . Event rates with treatment and placebo , and relative benefit ( RB ) and number needed to treat ( NNT ) were used as outputs from the meta‐analyses . The event rate with placebo was systematic ally statistically lower for dental than postsurgical pain for all four treatments . Event rates with analgesics , RB and NNT were infrequently different between the pain models . Systematic difference in the estimate of analgesic efficacy between dental and postsurgical pain models remains unproven , and , on balance , no major difference is likely Flurbiprofen ( Ansaid , Upjohn ) , a potent new analgesic and anti-inflammatory agent , was compared with phenylbutazone in 90 patients with ankylosing spondylitis . In this double-blind , r and omized , 26-week study , a total daily dose of 200 mg of flurbiprofen , administered three times daily , was as effective as 300 mg of phenylbutazone in controlling the pain and other symptoms of ankylosing spondylitis . In some patients , symptoms were adequately controlled by 150 mg of flurbiprofen per day , administered twice daily . There were no statistically significant differences between flurbiprofen and phenylbutazone in the investigators ' and patients ' assessment s of improvement at all key follow-up periods . In addition , there were no consistently significant differences between drugs in the efficacy pain scales and quantitative measurements studied . Flurbiprofen was well tolerated in doses of up to 300 mg per day , and no clinical ly significant laboratory abnormalities were detected . Flurbiprofen appears to be an excellent alternative to phenylbutazone in the management of patients with ankylosing spondylitis Abstract A previously established relationship for deriving dichotomous from continuous information in r and omised controlled trials ( RCTs ) of analgesics has been tested using an independent data set . Individual patient information from 18 RCTs of parallel‐group design in acute postoperative pain ( after abdominal , gynaecological and oral surgery ) was used to calculate the percentage of the maximum possible pain relief score ( % maxTOTPAR ) and the proportion of patients with > 50%maxTOTPAR for the different treatments . The relationship between the measures was investigated in 85 treatments with over 3400 patients . In 80 of 85 treatments ( 94 % ) agreement between calculated and actual number of patients with > 50%maxTOTPAR was within four patients per treatment and in 72 ( 85 % ) was within three ( average of 40 patients per treatment , range 21–58 patients ) . Summing the positive and negative differences between actual and calculated numbers of patients with > 50%maxTOTPAR gave an average difference of 0.30 patients per treatment arm . Reports of RCTs of analgesics frequently describe results of studies in the form of mean derived indices , rather than using discontinuous events , such as number or proportion of patients with 50 % pain relief . Because mean data inadequately describe information with a non‐normal distribution , combining mean data in systematic review s may compromise the results . Showing that dichotomous data can reliably be derived from mean data in acute pain studies enables data published as means to be used for quantitative systematic review s which require data in dichotomous form This single-dose , double-blind , r and omized , placebo-controlled study compared the efficacy of 50 mg of oral flurbiprofen ( Ansaid , Upjohn ) , 10 mg of intramuscular morphine sulfate , and placebo in 92 patients with moderate to severe postoperative gynecologic pain . According to pain intensity , pain relief , and pain intensity difference scores , the morphine-treated patients experienced significantly more pain reduction than the other patients by the first hour after treatment . The flurbiprofen group obtained the same level of significant pain relief as the morphine group by two hours after dosing , but relief persisted longer than in the morphine-treated patients . Evaluation of other efficacy variables revealed similar levels of significant pain reduction in both the flurbiprofen and morphine groups compared with the placebo group . Flurbiprofen was well tolerated and led to fewer side effects than either morphine or placebo & NA ; Reports of RCTs of analgesics frequently describe results of studies in the form of mean derived indices , rather than using discontinuous events — such as number or proportion of patients with 50 % pain relief . Because mean data inadequately describe information with a non‐normal distribution , combining mean data in systematic review s may compromise the results . Showing that dichotomous data can reliably be derived from mean data , at least in acute pain models , indicates that more meaningful overviews or meta‐ analysis may be possible . This study investigated the relationship between continuous and dichotomous analgesic measures in a set of individual patient data , and then used that relationship to derive dichotomous from continuous information in r and omised controlled trials ( RCTs ) of analgesics . Individual patient information from 13 RCTs of parallel‐group and crossover design in acute postoperative pain was used to calculate the percentage of the maximum possible pain relief score ( % maxTOTPAR ) and the proportion of patients with greater than 50 % pain relief ( > 50%maxTOTPAR ) for the different treatments . The relationship between the measures was investigated in 45 actual treatments and 10 000 treatments simulated using the underlying actual distribution ; 1283 patients had 45 separate treatments . Mean % maxTOTPAR correlated with the proportion of patients with > 50%maxTOTPAR ( r2 = 0.90 ) . The relationship calculated from all the 45 treatments predicted to within three patients the number of patients with more than 50 % pain relief in 42 of 45 treatments , and 98.8 % of 10 000 simulated treatments . For seven effective treatments , actual numbers‐needed‐to‐treat ( NNT ) to achieve > 50%maxTOTPAR compared with placebo were very similar to those derived from calculated data The analgesic efficacy of flurbiprofen 25 mg and 50 mg compared with aspirin 650 mg and placebo ( lactose ) was evaluated . Subjects were 164 dental out patients undergoing the surgical removal of impacted teeth . Each subject received a single dose of study medication and was evaluated hourly for six hours . Aspirin was superior to placebo in all measures of analgesic efficacy , and both dosages of flurbiprofen were superior to aspirin In a series of three studies involving dental out patients undergoing removal of impacted third molars , preoperative and postoperative administration of flurbiprofen ( Ansaid , Upjohn ) led to superior pain relief when compared with acetaminophen alone or in combination with oxycodone . Patient preference and global evaluations clearly favored flurbiprofen . Side effects were mild and generally more common in patients receiving the opiate/mild analgesic combination . In two additional studies , flurbiprofen and etidocaine , a long-acting local anesthetic , also result ed in significantly less postoperative pain than a combination of acetaminophen/oxycodone and lidocaine ; 67 percent of patients in the flurbiprofen plus etidocaine group reported no or only slight pain during the entire observation period . The greater analgesic efficacy of flurbiprofen appears to represent a genuine therapeutic advantage , since it is not achieved at the expense of greater side effects Pain , swelling , loss of function , and hyperthermia are acute postoperative sequelae of inflammation due to tissue injury during surgical procedures . Pharmacologic strategies for minimizing the clinical manifestations of surgical trauma are often directed toward blocking the formation or inhibiting the effects of the biochemical mediators of acute inflammation . This study compared two nonsteroidal anti-inflammatory drugs ( NSAIDs ) , flurbiprofen and ibuprofen , with a prototype glucocorticoid , methylprednisolone , in two replicate placebo-controlled studies for suppression of inflammation due to the surgical removal of impacted third molars . The results indicate that NSAIDs produce greater initial analgesia than do steroids , whereas steroids result in greater suppression of swelling and less loss of function . Examination of the pooled data from the two studies indicates that NSAID pretreatment results in a modest suppression of swelling in comparison with placebo . These data suggest that the acute analgesic effects of NSAIDs in the oral surgery model are due to suppression of a nociceptive process , presumably prostagl and in formation , rather than a generalized anti-inflammatory effect The purpose of this double-blind , r and omized , parallel , multiple-dose study was to compare the efficacy and safety of flurbiprofen with acetaminophen with codeine phosphate in the 96-hr postoperative period following foot surgery . Analysis of mean pain intensity and mean pain relief for the patients not requiring rescue medication did not reveal any significant differences between treatment groups . There were also no significant differences between treatment groups with respect to patient and investigator global evaluations of therapy . The incidence of termination of the study because of side effects was higher for the acetaminophen with codeine group This single-dose , double-blind , r and omized , placebo-controlled study assessed the efficacy and safety of 50 mg of flurbiprofen (
Output:
| Adverse events were uncommon , and not significantly different from placebo .
AUTHORS ' CONCLUSIONS Flurbiprofen at doses of 50 mg and 100 mg is an effective analgesic in moderate to severe acute postoperative pain .
The NNT for at least 50 % pain relief is similar to that of commonly used NSAIDs such as ibuprofen and naproxen at usual doses .
Use of rescue medication indicates a duration of action exceeding 6 hours |
MS212108 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: The frequent need to obtain an estimate of renal function in cancer patients , not least for targeting carboplatin dose , has led to a number of approaches to estimate glomerular filtration rate ( GFR ) . This study aim ed to develop a simple and reliable method to estimate GFR using readily-available patient characteristics . Data from 62 patients with estimates of 51Cr-EDTA clearance were analysed to determine the most appropriate formula relating this method of measuring GFR to patient characteristics . The population pharmacokinetics of 51Cr-EDTA were analysed using NONMEM to evaluate the influence of each covariate . The formulae derived were then vali date d using a further 38 patients and compared with those obtained using existing formulae 51Cr-EDTA clearance ( GFR ) was positively related to Dubois surface area , negatively related to age , and inversely related to serum creatinine ( SCr ) . Females had lower 51Cr-EDTA clearance than males . The enzymatic method of SCr assay gave more reliable results than the Jaffe colorimetric method . A measure of creatine kinase significantly improved the estimation of GFR . The new formula produced estimates of GFR which were less biased ( Mean Prediction Error = –3 % ) and more precise ( Mean Absolute Prediction Error = 12 % ) than Cockcroft and Gault ( –8 % and 16 % ) or Jelliffe ( –15 % and 19 % ) estimates . The formulae developed here can be used to provide reliable estimates of GFR , particularly in regard to targeted dosing of carboplatin . © 2001 Cancer Research BACKGROUND Assessment of the change in tumour burden is an important feature of the clinical evaluation of cancer therapeutics : both tumour shrinkage ( objective response ) and disease progression are useful endpoints in clinical trials . Since RECIST was published in 2000 , many investigators , cooperative groups , industry and government authorities have adopted these criteria in the assessment of treatment outcomes . However , a number of questions and issues have arisen which have led to the development of a revised RECIST guideline ( version 1.1 ) . Evidence for changes , summarised in separate papers in this special issue , has come from assessment of a large data warehouse ( > 6500 patients ) , simulation studies and literature review s. HIGHLIGHTS OF REVISED RECIST 1.1 : Major changes include : Number of lesions to be assessed : based on evidence from numerous trial data bases merged into a data warehouse for analysis purpose s , the number of lesions required to assess tumour burden for response determination has been reduced from a maximum of 10 to a maximum of five total ( and from five to two per organ , maximum ) . Assessment of pathological lymph nodes is now incorporated : nodes with a short axis of 15 mm are considered measurable and assessable as target lesions . The short axis measurement should be included in the sum of lesions in calculation of tumour response . Nodes that shrink to < 10 mm short axis are considered normal . Confirmation of response is required for trials with response primary endpoint but is no longer required in r and omised studies since the control arm serves as appropriate means of interpretation of data . Disease progression is clarified in several aspects : in addition to the previous definition of progression in target disease of 20 % increase in sum , a 5 mm absolute increase is now required as well to guard against over calling PD when the total sum is very small . Furthermore , there is guidance offered on what constitutes ' unequivocal progression ' of non-measurable/non-target disease , a source of confusion in the original RECIST guideline . Finally , a section on detection of new lesions , including the interpretation of FDG-PET scan assessment is included . Imaging guidance : the revised RECIST includes a new imaging appendix with up date d recommendations on the optimal anatomical assessment of lesions . FUTURE WORK A key question considered by the RECIST Working Group in developing RECIST 1.1 was whether it was appropriate to move from anatomic unidimensional assessment of tumour burden to either volumetric anatomical assessment or to functional assessment with PET or MRI . It was concluded that , at present , there is not sufficient st and ardisation or evidence to ab and on anatomical assessment of tumour burden . The only exception to this is in the use of FDG-PET imaging as an adjunct to determination of progression . As is detailed in the final paper in this special issue , the use of these promising newer approaches requires appropriate clinical validation studies BACKGROUND To compare the efficacy and toxicity of paclitaxel-carboplatin ( TAX-CBP ) and paclitaxel-cisplatin ( TAX-DDP ) chemotherapy protocol s for advanced non-small cell lung cancer . METHODS One hundred and twenty-six patients with non-small cell lung cancer were r and omized into TAX-DDP and TAX-CBP groups . TAX-CBP group : TAX 175 mg/m² and CBP 350 mg/m² , d1 iv ; TAX-DDP group : TAX 175 mg/m² and DDP 100 mg/m² d1 iv . The therapy was repeated every 28 days . The response rate was assessed after three treatments . RESULTS TAX-CBP group : response rate ( RR ) was 36 % ( 22/61 ) , 1-year survival rate was 34.1 % . TAX-DDP group : RR was 33.9 % (21/62),1-year survival rate was 33.1 % . There was no significant difference of RR and 1-year survival rate between TAX-CBP and TAX-DDP group ( P>0.05 ) . The median survival time of TAX-CBP group ( 11.2 months ) was significant higher than that of TAX-DDP group ( 9 months ) ( P<0.05 ) . The major toxicity associated with paclitaxel included alpecia , myelosuppression , gastrointestinal reaction and myalgia or arthralgia . The thrombocytopenia in TAX-CBP group was more severe than that in TAX-DDP group ( P<0.05 ) . The Gastrointestinal and myalgia or arthralgia in TAX-DDP group were more severe than those in TAX-CBP group ( P<0.05 ) . CONCLUSIONS TAX-CBP and TAX-DDP chemotherapy may be used as first choice protocol in the chemotherapy of non-small cell lung cancer In controlled clinical trials there are usually several prognostic factors known or thought to influence the patient 's ability to respond to treatment . Therefore , the method of sequential treatment assignment needs to be design ed so that treatment balance is simultaneously achieved across all such patients factor . Traditional methods of restricted r and omization such as " permuted blocks within strata " prove inadequate once the number of strata , or combinations of factor levels , approaches the sample size . A new general procedure for treatment assignment is described which concentrates on minimizing imbalance in the distributions of treatment numbers within the levels of each individual prognostic factor . The improved treatment balance obtained by this approach is explored using simulation for a simple model of a clinical trial . Further discussion centers on the selection , predictability and practicability of such a procedure Background : Bevacizumab , the anti-vascular endothelial growth factor agent , provides clinical benefit when combined with platinum-based chemotherapy in first-line advanced non-small-cell lung cancer . We report the final overall survival ( OS ) analysis from the phase III AVAiL trial . Patients and methods : Patients ( n = 1043 ) received cisplatin 80 mg/m2 and gemcitabine 1250 mg/m2 for up to six cycles plus bevacizumab 7.5 mg/kg ( n = 345 ) , bevacizumab 15 mg/kg ( n = 351 ) or placebo ( n = 347 ) every 3 weeks until progression . Primary end point was progression-free survival ( PFS ) ; OS was a secondary end point . Results : Significant PFS prolongation with bevacizumab compared with placebo was maintained with longer follow-up { hazard ratio ( HR ) [ 95 % confidence interval ( CI ) ] 0.75 ( 0.64–0.87 ) , P = 0.0003 and 0.85 ( 0.73–1.00 ) , P = 0.0456 } for the 7.5 and 15 mg/kg groups , respectively . Median OS was > 13 months in all treatment groups ; nevertheless , OS was not significantly increased with bevacizumab [ HR ( 95 % CI ) 0.93 ( 0.78–1.11 ) , P = 0.420 and 1.03 ( 0.86–1.23 ) , P = 0.761 ] for the 7.5 and 15 mg/kg groups , respectively , versus placebo . Most patients ( ∼62 % ) received multiple lines of post study treatment . Up date d safety results are consistent with those previously reported . Conclusions : Final analysis of AVAiL confirms the efficacy of bevacizumab when combined with cisplatin – gemcitabine . The PFS benefit did not translate into a significant OS benefit , possibly due to high use of efficacious second-line therapies BACKGROUND Bevacizumab , a monoclonal antibody against vascular endothelial growth factor , has been shown to benefit patients with a variety of cancers . METHODS Between July 2001 and April 2004 , the Eastern Cooperative Oncology Group ( ECOG ) conducted a r and omized study in which 878 patients with recurrent or advanced non-small-cell lung cancer ( stage IIIB or IV ) were assigned to chemotherapy with paclitaxel and carboplatin alone ( 444 ) or paclitaxel and carboplatin plus bevacizumab ( 434 ) . Chemotherapy was administered every 3 weeks for six cycles , and bevacizumab was administered every 3 weeks until disease progression was evident or toxic effects were intolerable . Patients with squamous-cell tumors , brain metastases , clinical ly significant hemoptysis , or inadequate organ function or performance status ( ECOG performance status , > 1 ) were excluded . The primary end point was overall survival . RESULTS The median survival was 12.3 months in the group assigned to chemotherapy plus bevacizumab , as compared with 10.3 months in the chemotherapy-alone group ( hazard ratio for death , 0.79 ; P=0.003 ) . The median progression-free survival in the two groups was 6.2 and 4.5 months , respectively ( hazard ratio for disease progression , 0.66 ; P<0.001 ) , with corresponding response rates of 35 % and 15 % ( P<0.001 ) . Rates of clinical ly significant bleeding were 4.4 % and 0.7 % , respectively ( P<0.001 ) . There were 15 treatment-related deaths in the chemotherapy-plus-bevacizumab group , including 5 from pulmonary hemorrhage . CONCLUSIONS The addition of bevacizumab to paclitaxel plus carboplatin in the treatment of selected patients with non-small-cell lung cancer has a significant survival benefit with the risk of increased treatment-related deaths . ( Clinical Trials.gov number , NCT00021060 . BACKGROUND In advanced not selected NSCLC chemotherapy achieved an advantage of approximately 1 - 2 months on median survival versus best supportive care . Chemotherapy seems to improve symptoms control , even if r and omised studies with quality of life as first endpoint are lacking and often chemotherapy toxicity compromises the frail cost/benefit ratio . The aim of the present study is to evaluate the impact on QoL , substituting cisplatin , a pivot drug in NSCLC therapy , with carboplatin , an analogue with an improved toxicity profile . The combination of cisplatin with Mitomycin and Vinblastine was one of the most frequently used in the palliative setting at the time of design of our study . METHODS Patients were r and omized to receive MVP regimen ( Mitomycin-C 8 mg/m2 d1 , Vinblastine 4 mg/m2 d 1 - 8 , Cisplatin 100 mg/m2 d1 ) or MVC regimen ( Mitomycin-C 8 mg/m2 d1 , Vinblastine 4 mg/m2 d 1 - 8 , Carboplatin 300 mg/m2 d1 ) every 3 weeks . The QoL was evaluated by the Spitzer QL-Index and by the EORTC QLQ-C30+LC 13 question naires before chemotherapy , after one cycle , after three cycles , and then every 6 weeks in the first 6 months and every 3 months thenafter . RESULTS From September 1994 to July 1997 , 153 consecutive patients were r and omized to MVP ( 75 patients ) or MVC arm ( 78 patients ) . Despite difficulties in carrying out and analysing QoL items in such patients , the global QoL evaluated by the Spitzer 's question naire suggested an advantage for MVC regimen ( P=0.05 ) and a significant difference was observed in global health subdomain ( P=0.04 ) . The disease-related symptoms improved with time , and the benefits lasted for the entire treatment period . When evaluated with the EORTC question naire there was significantly less nausea and vomiting ( P=0.0001 ) , appetite loss ( P=0.01 ) , insomnia ( P=0.03 ) , constipation ( P=0.01 ) and peripheral neuropathy ( P=0.01 ) in favour of MVC , and a trend for less hair loss ( P=0.05 ) . The advantage lasted for all the duration of chemotherapy .
Output:
| The initial treatment of people with advanced NSCLC is palliative , and carboplatin can be a treatment option .
It has a similar effect on survival but a different toxicity profile when compared with cisplatin . |
MS212109 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Transcutaneous electrical nerve stimulation ( TENS ) has been used to treat chronic pain syndromes and has been reported to be of some utility in the treatment of postsurgical pain . A r and omized , blinded , placebo-controlled trial was design ed to evaluate the utility of TENS after total knee arthroplasty . Patients were r and omly enrolled into patient-controlled anesthesia ( PCA ) alone , PCA plus TENS , or PCA plus sham TENS . The cumulative dose of morphine by PCA for each group was used as the end-point of the study . There was no significant reduction in the requirement for patient-controlled analgesia with or without TENS . We conclude that there is no utility for TENS in the postoperative management of pain after knee arthroplasty Abstract The influence of transcutaneous electrical stimulation ( TES ) and psychological factors in determining the intensity of acute postoperative pain was examined in a prospect i ve , double‐blind controlled trial completed by 30 patients having elective surgery . Psychometric tests were administered prior to surgery . Postoperative pain was assessed by cumulative morphine requirement ( M48 ) administered intramuscularly , and the mean score of a visual analogue scale of pain ( VAS ) , in the first 48 h following surgery . M48 was significantly correlated with the VAS score ( r = 0.62 , P < 0.001 ) , and with the psychometric test scores for trait‐anxiety ( r = 0.70 , P < 0.001 ) and neuroticism ( r = 0.67 , P < 0.001 ) . Though patients treated with TES required 25 % less morphine than those treated with placebo , the difference was not significant using monovariate analysis and applying unpaired two‐tailed Student 's t‐test ( P > 0.2 ) . When the contribution of neuroticism to the variance of M48 was adjusted using multiple regression analysis , the effect of TES became significant at the 0.05 level . Covariance analysis showed that TES contributed some 19 % to the explained variance of M48 while neuroticism contributed about 80 % , and there was no interaction between these two factors . These findings allow a degree of prediction of the individual patient 's postoperative pain and narcotic requirement , and point to a strong correlation between postoperative pain perception and personality Background Transcutaneous electrical nerve stimulation ( TENS ) is an effective adjunctive therapy for postoperative pain ; however , effects of different frequencies of stimulation have not been systematic ally investigated . Laparoscopic sterilization ( LS ) causes significant pain in the early postoperative period and requires substantial postoperative medication . Therefore , we studied the effects of TENS on postoperative pain after LS through placement of Yoon fallopian rings in a prospect i ve , r and omized , double-blinded , and placebo-controlled study . Methods Sixty-four patients undergoing LS for uterine tube ligation were r and omly allocated to receive either active TENS or placebo TENS . Postoperative pain was evaluated using a st and ard 11-point numeric rating scale and the McGill Pain Question naire (MPQ)-pain rating index and number of words chosen . Both high frequency ( 100 Hz ) and low frequency ( 4 Hz ) TENS , at strong , but comfortable sensory intensity , were applied for 20 minutes through 4 electrodes placed around the surgical incision immediately after surgery . Pain was assessed before and after application of TENS when patients were at postanesthesia care unit ( PACU ) . Results Both high and low frequency TENS significantly decreased postoperative pain intensity when compared with before administration of TENS using the numeric rating scale ( P=0.001 ) , pain rating index ( P=0.001 ) , and number of words chosen ( P=0.001 ) compared with placebo TENS ( P=0.001 ) . TENS in combination with st and ard pharmacologic analgesic treatment was efficacious for postoperative pain relief after LS . Conclusions We recommend regular use of multimodal therapy with TENS and analgesic drugs after LS with placement of Yoon rings Background and Objectives Continuous-infusion femoral nerve block ( FNB ) improves analgesia and rehabilitation after total knee replacement . In this study , we investigated the efficacy of single-injection FNB to achieve similar results . Methods A total of 30 patients were prospect ively and r and omly assigned to receive 40-mL injections of either 0.25 % bupivacaine ( group B ) or saline ( group S ) after total knee replacement . Blinded observers evaluated the patients for postoperative pain , morphine consumption , ambulating distances , and maximal knee flexion ; pain was scored on the visual analog scale ( VAS ) . Results Compared with group S patients , group B patients had significantly lower VAS pain scores ( P < .01 in the postoperative anesthesia care unit , P < .05 on the day after surgery ) ; group B patients also showed significantly lower total morphine use ( P < .05 ) and a lower incidence of morphine-related side effects . Significantly more group B than group S patients could ambulate on the day after surgery ( 93 % v 46 % , P < .05 ) , and mean ambulatory distance was significantly better for group B than group S patients at discharge ( 166 ± 37 v 117 ± 24 feet , P < .01 ) . Knee flexion was significantly better for group B than group S patients on the second day after surgery ( 70 ° v 60 ° , P < .01 ) , but the between-group difference was no longer statistically significant at discharge . Mean length of acute hospitalization was significantly shorter for group B ( 3 days ; range , 3 to 5 days ) than group S patients ( 4 days ; range , 3 to 6 days , P < .05 ) . Conclusions Single-injection FNB provided effective analgesia , facilitated early ambulation , and reduced the length of acute hospitalization in patients undergoing total knee replacement OBJECTIVE To investigate the possible effect of electric muscle stimulation ( EMS ) of the vastus medialis on the walking speed , Hospital for Special Surgery ( HSS ) knee score , and Physiological Cost Index ( PCI ) of patients during rehabilitation after total knee arthroplasty ( TKA ) . DESIGN Prospect i ve , r and omized controlled trial . SETTING Various departments at a district general hospital in the United Kingdom . PARTICIPANTS Thirty patients with unilateral osteoarthritis of the knee admitted for elective TKA were r and omly assigned to 1 of 2 groups ( 15 per group ) : control and treatment . Both groups received st and ard physical therapy . The treatment group also received EMS of the vastus medialis . INTERVENTION EMS ( 40Hz , 300micros ) of the vastus medialis muscle for 4 hours a day , starting on postoperative day 2 , over the first 6 postoperative weeks . MAIN OUTCOME MEASURES Changes in walking speed , HSS knee score , and effort of walking as measured by the PCI . RESULTS A statistically significant increase in walking speed was observed in the treatment group in relation to the control group at both 6 weeks ( P=.0002 ) and 12 weeks ( P<.0001 ) postoperatively . No statistically significant difference was observed in relation to the PCI or the HSS knee score variables . CONCLUSIONS Application of EMS after TKA result ed in a statistically significant improvement in patients ' walking speed . There was also a carry-over effect after the discontinuation of treatment BACKGROUND Transcutaneous electrical nerve stimulation ( TENS ) is regarded as an effective treatment for various types of pain . However , no r and omized controlled trial has investigated TENS on acupoints for postoperative analgesia in elderly patients . This study aim to investigate whether TENS on acupoints has any favorable effect on complementary analgesia after total hip arthroplasty ( THA ) for elderly patients compared with a sham control treatment . METHODS Sixty-eight elderly patients requiring THA surgery were enrolled and r and omly allocated to one of two groups . Group Acu received true TENS on acupoints ( bilateral P6 , L14 ; ST36 , GB31 ipsilateral to the surgery site ) and Group Sham received sham treatment . All patients received patient-controlled analgesia for two days postoperatively . Analgesia was assessed by postoperative fentanyl requirement and pain intensity using a visual analogue scale ( VAS-10 cm ) . The incidence of analgesia-related side effects , optional medication use and effects of patients ' blinding were recorded . RESULTS Fentanyl consumption in Group Acu was lower than that in Group Sham at 24 h ( mean ± SD ; 360±117 vs. 572±132 μg ; P<0.001 ) and 48 h ( 712±184 vs. 1022±197 μg ; P<0.001 ) after surgery . Postoperative pain intensity measured by VAS was similar in both groups . The incidence of opioid-related side effects and rescue medication for postoperative analgesia was significantly higher in Group Sham than in Group Acu . Differences between the groups regarding the effects of patients ' blinding were not significant . CONCLUSION TENS on specific acupoints is an effective and complementary approach to reduce postoperative analgesic requirement in elderly patients after THA OBJECTIVE To study the effects of transcutaneous electrical nerve stimulation on multimodal analgesia after total knee arthroplasty . METHODS Sixty patients diagnosed as knee osteoarthritis and suffered unilateral total knee arthroplasty in the department of orthopedics , Zhejiang Traditional Chinese Medicine Hospital from March 2009 to May 2012 were r and omly divided into control group and test group , 30 cases in each group . All the patients received celecoxib preoperatively , knee periarticular injection with the drug mixture intraoperatively , and celecoxib and morphine sulfate controlled-release tablets postoperatively . The patients in the test group were also treated with transcutaneous electrical nerve stimulation each day after operation . All the patients started doing functional exercises at 24 h after operation . Postoperative visual analogue scales(VAS ) , passive and active range of motion of knee joint , and complications were recorded . RESULTS The VAS scores of test group during postoperative 24 h to 1 week were 3.39 + /- 0.69 , 2.79 + /- 0.51 , 2.16 + /- 0.52 , and 1.07 + /- 0.57 separately , which were lower than 3.80 + /- 0.86 , 3.22 + /- 0.58 , 2.53 + /- 0.54 and 1.38 + /- 0.52 in the control group . The passive and active range of knee joint motion in the test group during postoperative 24 h to 2 weeks were ( 30.67 + /- 3.65 ) degrees , ( 39.17 + /- 3.96 ) degrees , ( 47.83 + /- 4.86 ) degrees , ( 93.67 + /- 7.30 ) degrees , ( 107.67 + /- 7.51 ) degrees and ( 29.83 + /- 5.33 ) degrees , ( 78.33 + /- 8.24 ) degrees , ( 95.17 + /- 5.94 ) degrees respectively , which were higher than ( 28.67 + /- 3.92 ) degrees , ( 36.83 + /- 4.25 ) degrees , ( 45.17 + /- 5.17 ) degrees , ( 89.83 + /- 7.25 ) degrees , ( 103.17 + /- 7.37 ) degrees and ( 24.17 + /- 10.26 ) degrees , ( 73.83 + /- 9.07 ) degrees , ( 91.33 + /- 7.42 ) degrees in the control group . In the test group , 19 patients had ring-shaped haemostasis impression to some extent in the skin of knee joint to different degree , and 5 patients had blister formation . CONCLUSION It is meaningful to apply transcutaneous electrical nerve stimulation for treating multimodal analgesia after total knee arthroplasty , which can not only relieve patients ' postoperative pain , and also promote the rehabilitation of knee function as far as possible OBJECTIVE Evaluate TENS effectiveness as a complementary treatment of chronic pelvic pain and deep dyspareunia in women with deep endometriosis . STUDY DESIGN This r and omized controlled trial was performed in a tertiary health care center , including twenty-two women with deep endometriosis undergoing hormone therapy with persistent pelvic pain and /or deep dyspareunia . This study was registered in the Brazilian Record of Clinical Trials ( ReBEC ) , under n RBR-3rndh6 . TENS application for 8 weeks followed a r and omized allocation into two groups : Group 1 - acupuncture-like TENS ( Frequency : 8Hz , pulse duration : 250μs ) - VIF ( n=11 ) and Group 2 - self-applied TENS ( Frequency : 85Hz , pulse duration : 75μs ) ( n=11 ) . The intensity applied was " strong , but comfortable " . We evaluated patients before and after treatment by the use of the Visual Analogue Scale , Deep Dyspareunia Scale and Endometriosis Quality of Life Question naire . We used
Output:
| Compared with control intervention , transcutaneous electrical nerve stimulation supplementation intervention was found to significantly reduce pain and morphine requirement over a period of 24 h and to promote functional recovery in patients who have undergone total knee arthroplasty |
MS212110 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: BACKGROUND Angiogenesis plays a role in the biology of ovarian cancer . We examined the effect of bevacizumab , the vascular endothelial growth factor inhibitor , on survival in women with this disease . METHODS We r and omly assigned women with ovarian cancer to carboplatin ( area under the curve , 5 or 6 ) and paclitaxel ( 175 mg per square meter of body-surface area ) , given every 3 weeks for 6 cycles , or to this regimen plus bevacizumab ( 7.5 mg per kilogram of body weight ) , given concurrently every 3 weeks for 5 or 6 cycles and continued for 12 additional cycles or until progression of disease . Outcome measures included progression-free survival , first analyzed per protocol and then up date d , and interim overall survival . RESULTS A total of 1528 women from 11 countries were r and omly assigned to one of the two treatment regimens . Their median age was 57 years ; 90 % had epithelial ovarian cancer , 69 % had a serous histologic type , 9 % had high-risk early-stage disease , 30 % were at high risk for progression , and 70 % had stage IIIC or IV ovarian cancer . Progression-free survival ( restricted mean ) at 36 months was 20.3 months with st and ard therapy , as compared with 21.8 months with st and ard therapy plus bevacizumab ( hazard ratio for progression or death with bevacizumab added , 0.81 ; 95 % confidence interval , 0.70 to 0.94 ; P=0.004 by the log-rank test ) . Nonproportional hazards were detected ( i.e. , the treatment effect was not consistent over time on the hazard function scale ) ( P<0.001 ) , with a maximum effect at 12 months , coinciding with the end of planned bevacizumab treatment and diminishing by 24 months . Bevacizumab was associated with more toxic effects ( most often hypertension of grade 2 or higher ) ( 18 % , vs. 2 % with chemotherapy alone ) . In the up date d analyses , progression-free survival ( restricted mean ) at 42 months was 22.4 months without bevacizumab versus 24.1 months with bevacizumab ( P=0.04 by log-rank test ) ; in patients at high risk for progression , the benefit was greater with bevacizumab than without it , with progression-free survival ( restricted mean ) at 42 months of 14.5 months with st and ard therapy alone and 18.1 months with bevacizumab added , with respective median overall survival of 28.8 and 36.6 months . CONCLUSIONS Bevacizumab improved progression-free survival in women with ovarian cancer . The benefits with respect to both progression-free and overall survival were greater among those at high risk for disease progression . ( Funded by Roche and others ; ICON7 Controlled-Trials.com number , IS RCT N91273375 . ) Investigators should properly calculate sample sizes before the start of their r and omised trials and adequately describe the details in their published report . In these a-priori calculations , determining the effect size to detect -- eg , event rates in treatment and control groups -- reflects inherently subjective clinical judgments . Furthermore , these judgments greatly affect sample size calculations . We question the br and ing of trials as unethical on the basis of an imprecise sample size calculation process . So-called underpowered trials might be acceptable if investigators use method ological rigor to eliminate bias , properly report to avoid misinterpretation , and always publish results to avert publication bias . Some shift of emphasis from a fixation on sample size to a focus on method ological quality would yield more trials with less bias . Unbiased trials with imprecise results trump no results at all . Clinicians and patients deserve guidance now PURPOSE The objective of this study was to compare the efficacy and safety of trabectedin plus pegylated liposomal doxorubicin ( PLD ) with that of PLD alone in women with recurrent ovarian cancer after failure of first-line , platinum-based chemotherapy . PATIENTS AND METHODS Women > or = 18 years , stratified by performance status ( 0 to 1 v 2 ) and platinum sensitivity , were r and omly assigned to receive an intravenous infusion of PLD 30 mg/m(2 ) followed by a 3-hour infusion of trabectedin 1.1 mg/m(2 ) every 3 weeks or PLD 50 mg/m(2 ) every 4 weeks . The primary end point was progression-free survival ( PFS ) by independent radiology assessment . RESULTS Patients ( N = 672 ) were r and omly assigned to trabectedin/PLD ( n = 337 ) or PLD ( n = 335 ) . Median PFS was 7.3 months with trabectedin/PLD v 5.8 months with PLD ( hazard ratio , 0.79 ; 95 % CI , 0.65 to 0.96 ; P = .0190 ) . For platinum-sensitive patients , median PFS was 9.2 months v 7.5 months , respectively ( hazard ratio , 0.73 ; 95 % CI , 0.56 to 0.95 ; P = .0170 ) . Overall response rate ( ORR ) was 27.6 % for trabectedin/PLD v 18.8 % for PLD ( P = .0080 ) ; for platinum-sensitive patients , it was 35.3 % v 22.6 % ( P = .0042 ) , respectively . ORR , PFS , and overall survival among platinum-resistant patients were not statistically different . Neutropenia was more common with trabectedin/PLD . Grade 3 to 4 transaminase elevations were also more common with the combination but were transient and noncumulative . H and -foot syndrome and mucositis were less frequent with trabectedin/PLD than with PLD alone . CONCLUSION When combined with PLD , trabectedin improves PFS and ORR over PLD alone with acceptable tolerance in the second-line treatment of recurrent ovarian cancer PURPOSE To compare the safety and efficacy of carboplatin and paclitaxel administered with or without the multidrug resistance modulator valspodar ( PSC 833 ) in untreated patients with advanced ovarian or primary peritoneal cancer . PATIENTS AND METHODS Seven hundred sixty-two patients with stage IV or suboptimally debulked stage III ovarian or primary peritoneal cancer were r and omly assigned to receive either valspodar 5 mg/kg every 6 hours for 12 doses , paclitaxel 80 mg/m(2 ) , and carboplatin area under the curve ( AUC ) 6 ( PC-PSC ; n = 381 ) or paclitaxel 175 mg/m(2 ) and carboplatin AUC 6 ( PC ; n = 381 ) . Time to disease progression ( TTP ) was the primary end point . Secondary end points were overall survival time ( OS ) , response rate ( RR ) , safety , and tolerability . RESULTS With a median follow-up of 736 days ( range , 1 to 2,280 days ) , the median TTP was 13.2 and 13.5 months in the PC-PSC and PC groups , respectively ( P = .67 ) ; the median OS was 32 and 28.9 months , respectively ( P = .94 ) . The overall RR was higher in the PC group ( 41.5 % v 33.6 % ; P = .02 ) . Central and peripheral nervous system and GI toxicities were more common in the PC-PSC group . Ataxia occurred in 53.5 % and 3.2 % of PC-PSC- and PC-treated patients , respectively . Febrile neutropenia occurred more frequently in the PC-PSC group . More PC-PSC-treated patients discontinued therapy because of adverse events ( AEs ) , experienced serious AEs , and required paclitaxel dose reductions . CONCLUSION The addition of valspodar to PC did not improve TTP or OS and was more toxic compared with PC in untreated patients with advanced ovarian or primary peritoneal cancer LBA1 Background : BEV , a humanized anti-VEGF monoclonal antibody , has demonstrated single-agent activity in patients with recurrent EOC , or PPC . The therapeutic impact of concurrent ± maintenance BEV with st and ard chemotherapy ( CT ) was evaluated in an international , double-blind , placebo-controlled phase III trial . METHODS Eligible patients had newly diagnosed , previously untreated EOC , PPC or FTC following abdominal surgery for staging and maximal effort at tumor debulking ; stage III ( macroscopic residual disease ) or stage IV disease . The r and omly allocated regimens were ( 1 ) CT ( IV paclitaxel 175 mg/m2 + carboplatin AUC 6 cycles 1 - 6 ) + placebo cycles (C)2 - 22 ( R1 ) ( 2 ) CT + concurrent BEV ( 15 mg/kg ) C2 - 6 + placebo C7 - 22 ( R2 ) ( 3 ) CT + concurrent BEV C2 - 6 + maintenance BEV C7 - 22 ( R3 ) Infusions were administered d1 of a 21d cycle . The primary endpoint is progression-free survival ( PFS ) ( radiographic , CA125 , clinical criteria or death ) ; secondary endpoints include overall survival , safety , and QoL. RESULTS 1,873 patients , median age 60 , were enrolled from 9/05 - 6/09 . Stage III optimally debulked ( 34 % ) , stage III sub-optimally debulked ( 40 % ) , and stage IV ( 26 % ) patients were similarly distributed in each treatment group . Grade 3 - 4 hypertension was reported in 1.6 % ( R1 ) , 5.4 % ( R2 ) , and 10.0 % ( R3 ) . Grade ≥ 3 GI perforation , hemorrhage or fistula occurred in 0.8 % ( R1 ) , 2.6 % ( R2 ) and 2.3 % ( R3 ) . Relative to R1 , the hazard of first progression or death for R2 was 0.908 ( 95 % CI : 0.795 - 1.04 , p=0.16 ) and for R3 was 0.717 ( 95 % CI : 0.625 - 0.824 , p<0.0001 ) . CONCLUSIONS This study demonstrates that front-line treatment of EOC , PPC , and FTC patients with CT plus concurrent and maintenance BEV prolongs PFS . This is the first anti-angiogenic agent to demonstrate benefit in this population . [ Table : see text ] PURPOSE To determine the side effects and feasibility of cisplatin and carboplatin each in combination with paclitaxel as front-line therapy in advanced epithelial ovarian cancer . PATIENTS AND METHODS Patients were r and omly allocated to receive paclitaxel 175 mg/m(2 ) intravenously as a 3-hour infusion followed by either cisplatin 75 mg/m(2 ) or carboplatin ( area under the plasma concentration-time curve of 5 ) , both on day 1 . The schedule was repeated every 3 weeks for at least six cycles . Women allocated to paclitaxel-cisplatin were admitted to the hospital , whereas the carboplatin regimen was administered to out patients . RESULTS A total of 208 eligible patients were r and omized . Both regimens could be delivered in an optimal dose and without significant delay . Paclitaxel-carboplatin produced significantly less nausea and vomiting ( P : < .01 ) and less peripheral neurotoxicity ( P : = .04 ) but more granulocytopenia and thrombocytopenia ( P : < .01 ) . The overall response rate in 132 patients with measurable disease was 64 % ( 84 of 132 patients ) , and in patients with elevated CA 125 levels at start , it was 74 % ( 132 of 178 patients ) . With a median follow-up time of 37 months , the median progression-free survival time of all patients was 16 months and the median overall survival time was 31 months . The small number of patients entered onto the study caused wide confidence intervals ( CIs ) around the hazards ratio for progression-free survival of paclitaxel-carboplatin compared with paclitaxel-cisplatin ( hazards ratio , 1.07 ; 95 % CI , 0.78 to 1.48 ) and did not allow conclusions about efficacy . CONCLUSION Paclitaxel-carboplatin is a feasible regimen for out patients with ovarian cancer and has a better toxicity profile than paclitaxel-cisplatin PURPOSE To analyze the effect of different doses of paclitaxel with fixed doses of carboplatin in the treatment of ovarian cancer . PATIENTS AND METHODS Patients with histologically confirmed epithelial ovarian cancer , International Federation of Gynecology and Obstetrics stages IIB to IV , were eligible for this r and omized , multicenter study . Women were r and omly assigned to treatment with ( 1 ) carboplatin at the dose ( in milligrams ) corresponding to the following formula : target area under the free carboplatin plasma concentration versus
Output:
| Survival of the control arm has frequently been underestimated in recent EOC RP3 trials .
Underestimating the outcome of the control arm may result in trials being underpowered to demonstrate the absolute benefit they were design ed to show |
MS212111 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: Background —Myocardial ischemia and infa rct ion impair baroreflex sensitivity ( BRS ) , which when depressed is predictive of future cardiac events after myocardial infa rct ion ( MI ) . The main objective of this study was to determine whether exercise training improves BRS in patients with coronary artery disease . Methods and Results —Ninety-seven male patients with and without a previous MI were recruited after myocardial revascularization surgery and r and omized into trained ( TR ) or untrained ( UTR ) groups . TR patients underwent a residential exercise program at 85 % of maximum heart rate ( HRmax ) consisting of 2 daily sessions 6 times a week for 2 weeks . Eighty-six patients ( 45 TR and 41 UTR ) completed the study . BRS was assessed at baseline and at the end of the protocol by the spontaneous baroreflex method . The st and ard deviation of mean R-R interval ( RRSD ) was also assessed as a measure of heart rate variability . At baseline , there were no significant differences between TR and UTR patients in any variable . In TR patients , BRS increased from 3.0±0.3 to 5.3±0.7 ms/mm Hg ( P < 0.001 ) , RRSD from 18.7±1.4 to 23.6±1.6 ms ( P < 0.01 ) , and R-R interval from 792.0±15.5 to 851.3±20.5 ms ( P < 0.001 ) . No significant changes occurred in UTR patients . Increases in BRS and RRSD were significant in patients either with or without a previous MI . Conclusions —Exercise training increases BRS and heart rate variability in patients with coronary artery disease . Improved cardiac autonomic function might add to the other benefits of exercise training in secondary prevention of ischemic heart disease In a multicentre trial 742 patients in 13 hospitals in Wales were r and omly allocated on the fifth day after uncomplicated myocardial infa rct ion to be mobilised on the fifth or the tenth day . The trial shows no difference in first year mortality , nor in morbidity assessed after a median period of 13 months . Follow-up after one year suggests an unexplained lower mortality during the second and third years in the late mobilisation group Abstract The effects of early mobilization after uncomplicated myocardial infa rct ion were investigated in a strictly r and omized controlled study conducted during a period of transition in the therapeutic practice of the Cantonal Hospital in Geneva , Switzerl and . One hundred fifty-four patients under age 70 who were hospitalized for acute myocardial infa rct ion and who had no complications on day 1 or day 2 were r and omly assigned to two treatment groups . In the early mobilization group , patients were treated by a physical therapist with a progressive activity program beginning on day 2 or 3 after infa rct ion . In the control group , patients underwent the traditional hospital regimen of strict bed rest for 3 or more weeks . The mean duration of hospitalization was 21.3 days for treated patients and 32.8 days for the control group . The follow-up period ranged from 6 to 20 ( average 11.2 ) months . There were no statistically significant differences between the two groups with regard to hospital or follow-up mortality , rate of reinfa rct ion , arrhythmias , heart failure , angina pectoris or ventricular aneurysm , or results of an exercise test . There was significantly greater disability in the control than in the treated group on follow-up examination . This controlled trial , based on a rigid experimental design , provides important confirmation of the benefits of early mobilization observed in uncontrolled programs in recent years Background —The predictive value of heart rate variability ( HRV ) in chronic heart failure ( CHF ) has never been tested in a comprehensive multivariate model using short-term laboratory recordings design ed to avoid the confounding effects of respiration and behavioral factors . Methods and Results —A multivariate survival model for the identification of sudden ( presumably arrhythmic ) death was developed with data from 202 consecutive patients referred between 1991 and 1995 with moderate to severe CHF ( age 52±9 years , left ventricular ejection fraction 24±7 % , New York Heart Association class 2.3±0.7 ; the derivation sample ) . Time- and frequency-domain HRV parameters obtained from an 8′ recording of ECG at baseline and during controlled breathing ( 12 to 15 breaths/min ) were challenged against clinical and functional parameters . This model was then vali date d in 242 consecutive patients referred between 1996 and 2001 ( validation sample ) . In the derivation sample , sudden death was independently predicted by a model that included low-frequency power ( LFP ) of HRV during controlled breathing ≤13 ms2 and left ventricular end-diastolic diameter ≥77 mm ( relative risk [ RR ] 3.7 , 95 % CI 1.5 to 9.3 , and RR 2.6 , 95 % CI 1.0 to 6.3 , respectively ) . The derivation model was also a significant predictor in the validation sample ( P = 0.04 ) . In the validation sample , LFP ≤11 ms2 during controlled breathing and ≥83 ventricular premature contractions per hour on Holter monitoring were both independent predictors of sudden death ( RR 3.0 , 95 % CI 1.2 to 7.6 , and RR 3.7 , 95 % CI 1.5 to 9.0 , respectively ) . Conclusions —Reduced short-term LFP during controlled breathing is a powerful predictor of sudden death in patients with CHF that is independent of many other variables . These results refine the identification of patients who may benefit from prophylactic implantation of a cardiac defibrillator A total of 189 patients with uncomplicated myocardial infa rct ion were selected at r and om for early or late mobilization and discharge from hospital . Patients were admitted to the study after 48 hours in a coronary care unit if they were free of pain and showed no evidence of heart failure or significant dysrhythmia . R and omization was achieved by monthly cross-over of the three medical wards to which the patients were discharged . One group of patients was mobilized immediately and discharged home after a total of nine days in hospital , and the second group was mobilized on the ninth day and discharged on the 16th day . Out-patient assessment was carried out six weeks after admission . No significant differences were observed between the groups in terms of mortality or morbidity , as reflected by the incidence of recurrent chest pain or myocardial infa rct ion , heart failure , dysrhythmia , or venous thromboembolism detected either clinical ly or by 125I-labelled fibrinogen scanning CONTEXT Trials comparing primary percutaneous coronary intervention ( PCI ) and thrombolytic therapy for treatment of acute myocardial infa rct ion ( MI ) suggest primary PCI is the superior therapy , although they differ with respect to the durability of benefit . Because PCI is often limited to hospitals that have on-site cardiac surgery programs , most acute MI patients do not have access to this therapy . OBJECTIVE To determine whether treatment of acute MI with primary PCI is superior to thrombolytic therapy at hospitals without on-site cardiac surgery and , if so , whether superiority is durable . DESIGN The Atlantic Cardiovascular Patient Outcomes Research Team ( C-PORT ) trial , a prospect i ve , r and omized trial conducted from July 1996 through December 1999 . SETTING Eleven community hospitals in Massachusetts and Maryl and without on-site cardiac surgery or extant PCI programs . PATIENTS Four hundred fifty-one thrombolytic-eligible patients with acute MI of less than 12 hours ' duration associated with ST-segment elevation on electrocardiogram . INTERVENTIONS After a formal primary PCI development program was completed at all sites , patients were r and omly assigned to receive primary PCI ( n = 225 ) or accelerated tissue plasminogen activator ( bolus dose of 15 mg and an infusion of 0.75 mg/kg for 30 minutes followed by 0.5 mg/kg for 60 minutes ; n = 226 ) . After initiation of assigned treatment , all care was determined by treating physicians . MAIN OUTCOME MEASURES Six-month composite incidence of death , recurrent MI , and stroke ; median hospital length of stay . RESULTS The incidence of the composite end point was reduced in the primary PCI group at 6 weeks ( 10.7 % vs 17.7 % ; P = .03 ) and 6 months ( 12.4 % vs 19.9 % ; P = .03 ) after index MI . Six-month rates for individual outcomes were 6.2 % vs 7.1 % for death ( P = .72 ) , 5.3 % vs 10.6 % for recurrent MI ( P = .04 ) , and 2.2 % vs 4.0 % for stroke ( P = .28 ) for primary PCI vs thrombolytic therapy , respectively . Median length of stay was also reduced in the primary PCI group ( 4.5 vs 6.0 days ; P = .02 ) . CONCLUSIONS Compared with thrombolytic therapy , treatment of patients with primary PCI at hospitals without on-site cardiac surgery is associated with better clinical outcomes for 6 months after index MI and a shorter hospital stay BACKGROUND In patients with ST-segment elevated myocardial infa rct ion ( STEMI ) , early post-thrombolysis routine angioplasty has been discouraged because of its association with high incidence of events . The GRACIA-1 trial was design ed to reassess the benefits of an early post-thrombolysis interventional approach in the era of stents and new antiplatelet agents . METHODS 500 patients with thrombolysed STEMI ( with recombinant tissue plasminogen activator ) were r and omly assigned to angiography and intervention if indicated within 24 h of thrombolysis , or to an ischaemia-guided conservative approach . The primary endpoint was the combined rate of death , reinfa rct ion , or revascularisation at 12 months . Analysis was by intention to treat . FINDINGS Invasive treatment included stenting of the culprit artery in 80 % ( 199 of 248 ) patients , bypass surgery in six ( 2 % ) , non-culprit artery stenting in three , and no intervention in 40 ( 16 % ) . Predischarge revascularisation was needed in 51 of 252 patients in the conservative group . By comparison with patients receiving conservative treatment , by 1 year , patients in the invasive group had lower frequency of primary endpoint ( 23 [ 9 % ] vs 51 [ 21 % ] , risk ratio 0.44 [ 95 % CI 0.28 - 0.70 ] , p=0.0008 ) , and they tended to have reduced rate of death or reinfa rct ion ( 7 % vs 12 % , 0.59 [ 0.33 - 1.05 ] , p=0.07 ) . Index time in hospital was shorter in the invasive group , with no differences in major bleeding or vascular complications . At 30 days both groups had a similar incidence of cardiac events . In-hospital incidence of revascularisation induced by spontaneous recurrence of ischaemia was higher in patients in the conservative group than in those in the invasive group . INTERPRETATION In patients with STEMI , early post-thrombolysis catheterisation and appropriate intervention is safe and might be preferable to a conservative strategy since it reduces the need for unplanned in-hospital revascularisation , and improves 1-year clinical outcome To determine the effects of early ambulation on peripheral venous thrombosis in the coronary care unit , 29 patients with acute myocardial infa rct ion had daily 125I-fibrinogen point counting of both legs using a st and ard portable technique in the first 3 to 7 days after admission . Twenty-one patients underwent early ambulation during the initial 3 days , while 8 remained at complete bed rest for 5 days . Only 2 of 21 early ambulated patients had positive fibrinogen point counts , in contrast to 5 of 8 nonambulated patients ( P less than 0.01 ) . With heart failure , only 2 of 9 ambulated patients had positive point counts , compared with 4 of 5 nonambulated patients ( P less than 0.05 ) . In 16 patients undergoing venography , point counts were confirmed in 6 positive and 10 negative findings . These results show that the high frequency of peripheral venous thrombosis in immobilized acute myocardial infa rct ion patients , particularly those with heart failure , can be effectively reduced by early ambulation Early mobilisation after acute myocardial infa rct ion is said to increase the risk of ventricular aneurysm and -rupture , reinfa rct ion , sudden death , and heart failure . In order to evaluate these possible negative effects , we run a prospect i ve and controlled study : 2 X 100 consecutive patients with acute myocardial infa rct ion were mobilized conventionally ( A ) and according to an early mobilisation programme ( B ) respectively-the two groups were comparable according to age , sex , CHD-history , infa rct ion transmural/non transmural and coronary prognostic index ( Norris ) . There was a significant reduction in the average hospital stay from 31.4 days in group A to 25.8 in group B. The patients were followed up for 32 ( A ) and 46 days ( B ) respectively . In the early mobilized group we found no increased risk for heart failure , reinfa rct ion , or sudden death . On the other side , early mobilisation has many psychological , oeconomic and social advantages for patients and hospital A
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| Our meta- analysis demonstrated a trend towards decreased mortality with EM after AMI . |
MS212112 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
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Input: Underserved minority population s in the US Affiliated Pacific Isl and s ( USAPI ) , Hawaii , and Alaska display disproportionate rates of childhood obesity . The region ’s unique circumstance should be taken into account when design ing obesity prevention interventions . The purpose of this paper is to ( a ) , describe the community engagement process ( CEP ) used by the Children ’s Healthy Living ( CHL ) Program for remote underserved minority population s in the USAPI , Hawaii , and Alaska ( b ) report community-identified priorities for an environmental intervention addressing early childhood ( ages 2–8 years ) obesity , and ( c ) share lessons learned in the CEP . Four communities in each of five CHL jurisdictions ( Alaska , American Samoa , Commonwealth of the Northern Mariana Isl and s , Guam , Hawai‘i ) were selected to participate in the community-r and omized matched-pair trial . Over 900 community members including parents , teachers , and community leaders participated in the CEP over a 14 month period . The CEP was used to identify environmental intervention priorities to address six behavioral outcomes : increasing fruit/vegetable consumption , water intake , physical activity and sleep ; and decreasing screen time and intake of sugar sweetened beverages . Community members were engaged through Local Advisory Committees , key informant interviews and participatory community meetings . Community-identified priorities centered on policy development ; role modeling ; enhancing access to healthy food , clean water , and physical activity venues ; and healthy living education . Through the CEP , CHL identified culturally appropriate priorities for intervention that were also consistent with the literature on effective obesity prevention practice s. Results of the CEP will guide the CHL intervention design and implementation . The CHL CEP may serve as a model for other underserved minority isl and population Background We report the main results , among adults , of a cluster-r and omised-trial of Well London , a community-engagement programme promoting healthy eating , physical activity and mental well-being in deprived neighbourhoods . The hypothesis was that benefits would be neighbourhood-wide , and not restricted to intervention participants . The trial was part of a multicomponent process/ outcome evaluation which included non-experimental components ( self-reported behaviour change amongst participants , case studies and evaluations of individual projects ) which suggested health , well-being and social benefits to participants . Methods Twenty matched pairs of neighbourhoods in London were r and omised to intervention/control condition . Primary outcomes ( five portions fruit/vegetables/day ; 5 × 30 m of moderate intensity physical activity/week , abnormal General Health Question naire (GHQ)-12 score and Warwick – Edinburgh Mental Well-being Scale ( WEMWBS ) score ) were measured by postintervention question naire survey , among 3986 adults in a r and om sample of households across neighbourhoods . Results There was no evidence of impact on primary outcomes : healthy eating ( relative risk [ RR ] 1.04 , 95 % CI 0.93 to 1.17 ) ; physical activity ( RR:1.01 , 95 % CI 0.88 to 1.16 ) ; abnormal GHQ12 ( RR:1.15 , 95 % CI 0.84 to 1.61 ) ; WEMWBS ( mean difference [ MD ] : −1.52 , 95 % CI −3.93 to 0.88 ) . There was evidence of impact on some secondary outcomes : reducing unhealthy eating-score ( MD : −0.14 , 95 % CI −0.02 to 0.27 ) and increased perception that people in the neighbourhood pulled together ( RR : 1.92 , 95 % CI 1.12 to 3.29 ) . Conclusions The trial findings do not provide evidence supporting the conclusion of non-experimental components of the evaluation that intervention improved health behaviours , well-being and social outcomes . Low participation rates and population churn likely compromised any impact of the intervention . Imprecise estimation of outcomes and sampling bias may also have influenced findings . There is a need for greater investment in refining such programmes before implementation ; new methods to underst and , longitudinally different pathways residents take through such interventions and their outcomes , and new theories of change that apply to each pathway Objective : To evaluate the effectiveness of a lay delivered intervention to reduce Latino children ’s exposure to environmental tobacco smoke ( ETS ) . The a priori hypothesis was that children living in households that were in the intervention group would have lower exposure over time than measurement only controls . Design : A two group , r and omised control trial was conducted . Setting : Areas of San Diego county with a large Latino population . Participants : 143 Latino parent – child pairs . Intervention : Trained bicultural and bilingual Latina lay community health advisors , or promotoras , conducted problem solving aim ed at lowering the target child ’s exposure to ETS in the household . Six home and telephone sessions were delivered by the promotoras over a four month period . Main outcome measures : Outcome measures were collected at baseline , immediately post-intervention , three months post-intervention , and 12 months post-intervention . Four outcomes were considered : ( 1 ) parent ’s paper- and -pencil reports of the child ’s past month exposure ; ( 2 ) hair sample s from the child analysed for past month nicotine ; ( 3 ) hair sample s from the child analysed for past month cotinine ; and ( 4 ) per cent confirmed reducers . Results : There were no significant condition-by-time interactions , the term indicative of a differential intervention effect . Significant or near significant time main effects were seen for children ’s hair cotinine , per cent confirmed reducers , and , in particular , parent reports of exposure . Conclusions : Applying a lay promotora model to deliver the behavioural problem solving intervention unfortunately was not effective . A likely explanation relates to the difficulty of delivering a relatively complex intervention by lay women untrained in behaviour change theory and research methods Background Cardiovascular disease remains the leading killer of women in most developed areas of the world . Rates of physical inactivity and poor nutrition , which are two of the most important modifiable risk factors for cardiovascular disease in women , are substantial . This study sought to examine the effectiveness of a community-based lifestyle-modification program on increasing women 's physical activity in a r and omized trial guided by community-based participatory research ( CBPR ) methods . Methods A total of 335 healthy , 25–64 years old women who had been selected by a multiple-stage stratified cluster r and om sampling method in Bushehr Port/I.R. Iran , were r and omized into control and intervention groups . The intervention group completed an 8-week lifestyle modification program for increasing their physical activity , based on a revised form of Choose to Move program ; an American Heart Association Physical Activity Program for Women . Audio-taped activity instructions with music and practical usage of the educational package were given to the intervention group in weekly home-visits by 53 volunteers from local non-governmental and community-based organizations . Results Among the participants , the percentage who reported being active ( at lease 30 minutes of moderate intensity physical activity for at least 5 days a week , or at least 20 minutes of vigorous physical activity for at least three days a week ) increased from 3 % and 2.7 % at baseline to 13.4 % and 3 % ( p < 0.0001 ) at the ending of the program in the intervention and control groups , respectively . The participants in the intervention group reported more minutes of physical activity per week ( mean = 139.81 , SE = 23.35 ) than women in the control group ( mean = 40.14 , SE = 12.65 ) at week 8 ( p < 0.0001 ) . The intervention group subjects exhibited a significantly greater decrease in systolic blood pressure ( -10.0 mmHg ) than the control group women ( + 2.0 . mmHg ) . The mean ranks for posttest healthy heart knowledge in the intervention and control groups were 198.91 and 135.77 , respectively ( P < 0.0001 ) . Conclusion An intervention based on CBPR methods can be effective for the short-term adoption of physical activity behavior among women . The development of participatory process to support the adequate delivery of lifestyle-modification programs is feasible and an effective healthcare delivery strategy for cardiovascular community health promotion . Trial Registration This study tested the effects of an exercise and diet modification training program for weight loss among Latinas . Forty four obese women were assigned to an experimental training group ( n = 22 ) or a control ( n = 22 ) , at r and om . One session per week for eight weeks included instruction for diet modification and walking for exercise , and all women were led in 20 min of walking during each session . Instruction was provided by a bi-cultural Spanish-speaking physician . Statistically significant ( P < 0.05 ) decreases , relative to controls , were obtained for Body Mass Index , waist to hip ratio , and serum cholesterol . Significant increases were obtained for fitness , exercise rate and frequency , and diet/exercise knowledge . Results suggest that the training was effective for decreasing obesity and increasing fitness among Low SES , Mexican-American women . Implication s for weight control and disease prevention among under-served population s are discussed Introduction The high prevalence of cardiovascular disease ( CVD ) in the Hispanic population of the United States , together with low rates of health insurance coverage , suggest a potential cardiovascular health crisis . The objective of Project HEART ( Health Education Awareness Research Team ) was to promote behavior changes to decrease CVD risk factors in a high-risk Hispanic border population . Methods Project HEART took place from 2005 through 2008 as a r and omized community trial with a community-based participatory research framework using promotores de salud ( community health workers ) . A total of 328 participants with at least 1 CVD risk factor were selected by r and omizing 10 US Census tracts in El Paso , Texas , to either the experimental or the control group . The experimental group ( n = 192 ) was assigned to a series of 8 health classes using the Su Corazón , Su Vida curriculum . After 2 months of educational sessions , the group was followed for 2 months . The control group ( n = 136 ) was given basic educational material s at baseline , and no other intervention was used . Main outcomes of interest included changes in health behaviors and clinical measures . Results Participants in the experimental group showed more awareness of CVD risk factors , more confidence in the control of these factors , and improved dietary habits ( ie , lower salt and cholesterol intake , better weight-control practice s ) compared with the control group . Total cholesterol was 3 % lower in the experimental than in the control participants , and non – high-density lipoprotein cholesterol and low-density lipoprotein cholesterol were both 5 % lower . Conclusion The HEART trial suggests that community health education using promotores de salud is a viable strategy for CVD risk reduction in a Hispanic border community BACKGROUND Community mobilisation through participatory women 's groups might improve birth outcomes in poor rural communities . We therefore assessed this approach in a largely tribal and rural population in three districts in eastern India . METHODS From 36 clusters in Jharkh and and Orissa , with an estimated population of 228 186 , we assigned 18 clusters to intervention or control using stratified r and omisation . Women were eligible to participate if they were aged 15 - 49 years , residing in the project area , and had given birth during the study . In intervention clusters , a facilitator convened 13 groups every month to support participatory action and learning for women , and facilitated the development and implementation of strategies to address maternal and newborn health problems . The primary outcomes were reductions in neonatal mortality rate ( NMR ) and maternal depression scores . Analysis was by intention to treat . This trial is registered as an International St and ard R and omised Controlled Trial , number IS RCT N21817853 . FINDINGS After baseline surveillance of 4692 births , we monitored outcomes for 19 030 births during 3 years ( 2005 - 08 ) . NMRs per 1000 were 55.6 , 37.1 , and 36.3 during the first , second , and third years , respectively , in intervention clusters , and 53.4 , 59.6 , and 64.3 , respectively , in control clusters . NMR was 32 % lower in intervention clusters adjusted for clustering , stratification , and baseline differences ( odds ratio 0.68 , 95 % CI 0.59 - 0.78 ) during the 3 years , and 45 % lower in years 2 and 3 ( 0.55 , 0.46 - 0.66 ) . Although we did not note a significant effect on maternal depression overall , reduction in moderate depression was 57 % in year 3 ( 0.43 , 0.23 - 0.80 ) . INTERPRETATION This intervention could be used with or as a potential alternative to health-worker-led interventions , and presents new opportunities for policy makers to improve maternal and newborn health outcomes in poor population s. FUNDING Health Foundation , UK Department for International Development , Wellcome Trust , and the Big Lottery Fund ( UK ) ABSTRACT BACKGROUND Depression contributes to disability and there are ethnic/racial disparities in access and outcomes of care . Quality improvement ( QI ) programs for depression in primary care improve outcomes relative to usual care , but health , social and other community-based service sectors also support clients in under-re source d communities . Little is known about effects on client outcomes of strategies to implement depression QI across diverse sectors . OBJECTIVE To compare the effectiveness of Community Engagement and Planning ( CEP ) and Re sources for Services ( RS ) to implement depression QI on clients ’ mental health-related quality of life ( HRQL ) and services use . DESIGN Matched programs from health , social and other service sectors were r and omized to community engagement and planning ( promoting inter-agency collaboration ) or re sources for services ( individual program technical
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| Conclusions The findings suggest that CE models can lead to improved health and health behaviours among disadvantaged population s if design ed properly and implemented through effective community consultation and participation . |
MS212113 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
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Input: Laboratory tests are purported to affect patients even if they have no diagnostic values . We tested this hypothesis by measuring clinical outcomes of 176 patients thought clinical ly to have nonspecific chest pain . They were r and omly allocated either to have a routine electrocardiogram and serum creatine phosphokinase tests ( test group ) or to have all diagnostic tests withheld ( no-test group ) . Fewer patients in the tests group ( 20 % ) reported short-term disability after the index visit than patients in the no-test group ( 46 % ) ( p = 0.001 ) . Logistic discriminant analysis confirmed that the use of diagnostic tests was an independent predictor of recovery . Patients in the test group felt that care was " better than usual " more often ( 57 % ) than patients in the no-test group ( 31 % ) ( p = 0.001 ) . After the index visit , the two groups were equally worried about serious disease and equally sparing in their use of other medial care for chest pain Objective To investigate whether providing information about normal findings before a diagnostic test improves patients ' reassurance and reduces anxiety about symptoms . Design R and omised controlled trial . Setting Outpatient cardiology clinic . Participants 92 patients with chest pain referred for a diagnostic exercise stress test . Intervention Before undergoing testing patients were r and omised to receive st and ard information ( n=28 ; control group ) , a pamphlet explaining the function of the test and the meaning of normal test results ( n=30 ; pamphlet group ) , or the pamphlet and a brief discussion about the meaning of normal test results ( n=34 ; discussion group ) . Main outcome measures The primary outcome was patients ' reported reassurance on a 5 item scale immediately after the test and at one month . Secondary outcomes were the proportion of patients still with chest pain and still taking cardiac drugs at one month . Results The mean levels of reassurance after testing and feedback from the doctor were significantly higher in the discussion group ( 42.0 , 95 % confidence interval 39.7 to 44.2 ) than in the pamphlet ( 39.2 , 36.1 to 42.3 ) and control groups ( 35.8 , 31.6 to 39.9 ) . This difference was maintained at one month . The proportion of patients still reporting chest pain at one month decreased significantly in the discussion group ( to 17 % ) and pamphlet group ( to 28 % ) but not in the control group ( to 36 % ) . A trend was for fewer patients in the discussion group to be taking cardiac drugs at one month . Conclusion Providing patients with information about normal test results before testing can improve rates of reassurance and reduce the likelihood of future reports of chest pain . Trial registration Current Controlled Trials IS RCT N87589121 Objectives : Aims were to investigate ( a ) whether neuroimaging in patients with chronic daily headache reassures patients or fails to reassure them and /or worsens outcome , impacting on service use , costs , health anxieties , and symptoms , and ( b ) whether this reassurance process occurs differentially in patients with different levels of psychological morbidity . Methods : Design : r and omised controlled trial ; setting : headache clinic in secondary care , South London ; participants : 150 patients fulfilling criteria for chronic daily headache , stratified using the Hospital Anxiety and Depression Scale ( HADS ) ; intervention : treatment as usual or the offer of an MRI brain scan ; main outcome measures : use of services , costs , and health anxiety . Results : Seventy six patients were r and omised to the offer of a brain scan and 74 patients to treatment as usual . One hundred and thirty seven ( 91 % ) primary care case notes were examined at 1 year , 103 ( 69 % ) patients completed question naires at 3 months and 96 ( 64 % ) at 1 year . Sixty six ( 44 % ) patients were HADS positive ( scored > 11 on either subscale ) . Patients offered a scan were less worried about a serious cause of the headaches at 3 months ( p = 0.004 ) , but this was not maintained at 1 year ; other health anxiety measures did not differ by scan status . However , at 1 year HADS positive patients offered a scan cost significantly less , by £ 465 ( 95 % confidence interval ( CI ) : −£1028 to −£104 ) , than such patients not offered a scan , due to lower utilisation of medical re sources . Conclusions : Neuroimaging significantly reduces costs for patients with high levels of psychiatric morbidity , possibly by changing subsequent referral patterns of the general practitioner Abstract Objective : To determine the cost effectiveness of a strategy of near patient Helicobacter pylori testing and endoscopy for managing dyspepsia . Design : R and omised controlled trial . Setting : 31 UK primary care centres . Participants : 478 patients under 50 years old presenting with dyspepsia of longer than four weeks duration . Interventions : Near patient testing for H pylori and open access endoscopy for patients with positive results . Control patients received acid suppressing drugs or specialist referral at general practitioner 's discretion . Main outcome measures : Cost effectiveness based on improvement in symptoms and use of re sources at 12 months ; quality of life . Results : 40 % of the study group tested positive for H pylori . 45 % of study patients had endoscopy compared with 25 % of controls . More peptic ulcers were diagnosed in the study group ( 7.4 % v 2.1 % , P=0.011 ) . Paired comparison of symptom scores and quality of life showed that all patients improved over time with no difference between study and control groups . No significant differences were observed in rates of prescribing , consultation , or referral . Costs were higher in the study group ( £ 367.85 v £ 253.16 per patient ) . Conclusions : The test and endoscopy strategy increases endoscopy rates over usual practice in primary care . The additional cost is not offset by benefits in symptom relief or quality of life . What is already known on this topic Patients younger than 50 without H pylori infection are unlikely to have treatable disease detected at endoscopy Such patients can be managed by acid suppression and reassurance alone Test and endoscopy ( referral of patients testing positive for H pyloriin primary care ) has been recommended as a way to reduce endoscopic workload What this paper adds Applying a test and endoscopy strategy increased the endoscopy referral rate from 25 % to 40 % The strategy produced no significant differences in symptoms or quality of life compared with usual management The increased costs of this strategy can not be Objectives To determine whether providing an information sheet to patients with acute chest pain reduces anxiety , improves health related quality of life , improves satisfaction with care , or alters subsequent symptoms or actions . Design Single centre , non-blinded , r and omised controlled trial . Setting Chest pain unit of an emergency department . Participants 700 consecutive patients with acute chest pain and no clear diagnosis at initial presentation . Interventions After a diagnostic assessment patients were r and omised to receive either st and ard verbal advice or verbal advice followed by an information sheet . Main outcome measures The primary outcome was anxiety ( hospital anxiety and depression scale ) . Secondary outcomes were depression ( hospital anxiety and depression scale ) , health related quality of life ( SF-36 ) , patient satisfaction , presentation with further chest pain within one month , lifestyle change ( smoking cessation , diet , exercise ) , further information sought from other sources , and planned healthcare seeeking behaviour in response to further pain . Results 494 of 700 ( 70.6 % ) patients responded . Compared with those receiving st and ard verbal advice those receiving advice and an information sheet had lower mean hospital anxiety and depression scale scores for anxiety ( 7.61 v 8.63 , difference 1.02 , 95 % confidence interval 0.20 to 1.84 ) and depression ( 4.14 v 5.28 , difference 1.14 , 0.41 to 1.86 ) and higher scores for mental health and perception of general health on the SF-36 . The information sheet had no significant effect on satisfaction with care , subsequent symptoms , lifestyle change , information seeking , or planned actions in the event of further pain . Conclusions Provision of an information sheet to patients with acute chest pain can reduce anxiety and depression and improve mental health and perception of general health but does not alter satisfaction with care or other outcomes . Trial registration Current Controlled Trials IS RCT N85248020 BACKGROUND Lumbar spine radiography has limited use in diagnosing the cause of acute low back pain . Consensus-based guidelines recommend that lumbar spine x-rays are not used routinely . However there have been no studies of the effect of referral for radiography at first presentation with low back pain in primary care . AIM To compare short and long-term physical , social , and psychiatric outcomes for patients with low back pain who are referred or not referred for lumbar spine x-ray at first presentation in general practice . DESIGN OF STUDY A r and omised unblinded controlled trial with an observational arm to enable comparisons to be made with patients not recruited to the trial . SETTING Ninety-four general practice s in south London and the South Thames region . METHOD Patients consulting their general practitioner ( GP ) with low back pain at first presentation were recruited to a r and omised controlled trial ( RCT ) or to an observational group . Patients in the trial were r and omly allocated to immediate referral for x-ray or to no referral . All patients were asked to complete question naires initially , and then at six weeks and one year after recruitment . RESULTS Six hundred and fifty-nine patients were recruited over 26 months : 153 to the r and omised trial and 506 to the observational arm . In the RCT referral for x-ray had no effect on physical functioning , pain or disability , but was associated with a small improvement in psychological wellbeing at six weeks and one year . These findings were supported by the observational study in which there were no differences between the groups in physical outcomes after adjusting for length of episode at presentation ; however , those referred for x-ray had lower depression scores . CONCLUSIONS Referral for lumbar spine radiography for first presentation of low back pain in primary care is not associated with improved physical functioning , pain or disability . The possibility of minor psychological improvement should be balanced against the high radiation dose involved PURPOSE To establish whether early use of magnetic resonance ( MR ) imaging or computed tomography ( CT ) influences treatment and outcome of patients with low back pain ( LBP ) and whether it is cost-effective . MATERIAL S AND METHODS In a multicenter r and omized study , two imaging policies for LBP were compared in 782 participants with symptomatic lumbar spine disorders who were referred to orthopedists or neurosurgeons . Participants were r and omly allocated to early ( 393 participants ; mean age , 43.9 years ; range , 16 - 82 years ) or delayed selective ( 389 participants ; mean age , 42.8 years ; range , 14 - 82 years ) imaging groups . Delayed selective imaging referred to imaging restricted to patients in whom a clear clinical need subsequently developed . Main outcome measures were Aberdeen Low Back Pain ( ALBP ) score , Short Form 36 ( SF-36 ) score ( for multidimensional health status ) , EuroQol ( EQ-5D ) score ( for quality -adjusted life-year [ QALY ] estimates ) , and healthcare re source use at 8 and 24 months after r and omization . Data were evaluated with analysis of covariance , ordinal logistic regression analysis , and chi(2 ) and Mann-Whitney tests . RESULTS Both groups showed improvement in ALBP score , but this was greater in the early group ( adjusted mean difference between groups , -3.05 points [ 95 % CI : -5.16 , -0.95 ; P = .005 ] and -3.62 points [ 95 % CI : -5.92 , -1.32 ; P = .002 ] at 8 and 24 months , respectively ) . Scores for SF-36 ( bodily pain domain ) and EQ-5D were also significantly better at 24 months . Clinical treatment was similar in both groups . Differences in total costs reflected cost of imaging . Imaging provided an adjusted mean additional QALY of 0.041 during 24 months at a mean incremental cost per QALY of $ 2,124 . CONCLUSION Early use of imaging does not appear to affect treatment overall . Decisions about the use of imaging depend on judgments concerning whether the small observed improvement in outcome justifies additional cost CONTEXT Somatoform disorders are an important determinant of medical care utilization , but their independent effect on utilization is difficult to determine because somatizing patients frequently have psychiatric and medical comorbidity . OBJECTIVES To assess the extent of the overlap of somatization with other psychiatric disorders ; to compare the medical utilization of somatizing and nonsomatizing patients ; and to determine the independent contribution of somatization alone to utilization . DESIGN Patients were surveyed with self-report question naires assessing somatization and psychiatric disorder . Medical care utilization was obtained from automated encounter data for the year preceding the index visit . Medical morbidity was indexed with a computerized medical record audit . SETTING Two hospital-affiliated primary care practice s. PARTICIPANTS Consecutive adults making scheduled visits to their primary care physicians on r and omly chosen days . In all , 2668 question naires were distributed , and 1914 ( 71.7 % ) were returned . Of these , 1546 ( 80.8 % ) contained complete data and met eligibility criteria . MAIN OUTCOME MEASURES Medical care utilization and costs within our hospital system in the preceding 12 months . RESULTS Two hundred ninety-nine patients ( 20.5 % ) received a provisional diagnosis of somatization ; 42.3 % of these patients had no comorbid depressive or anxiety disorder . Somatizing patients , when compared with nonsomatizing patients
Output:
| AND RELEVANCE Diagnostic tests for symptoms with a low risk of serious illness do little to reassure patients , decrease their anxiety , or resolve their symptoms , although the tests may reduce further primary care visits . |
MS212114 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: BACKGROUND While a variety of epidermal wound closure techniques are utilized , there are few evidence based studies comparing techniques in head-to-head studies . OBJECTIVE To compare the aesthetic outcomes and wound healing properties of 2 epidermal closure mechanisms : 2-octylethylcyanoacrylate adhesive and rapid absorbing gut suture in skin closures . METHODS A total of 8 patients were enrolled in this r and omized right-left comparative trial . Patients were r and omized for epidermal closure with one half of their wounds ( chest [ n=6 ] and upper extremities [ n=2 ] ) with tissue adhesive and the contralateral with rapid absorbing gut suture . RESULTS Three months following wound closure , overall cosmetic outcome was slightly greater on the half closed with rapid absorbing gut suture ( mean=3.56 ) relative to the tissue adhesive ( mean=3.19 , P=.05 ) . For dyspigmentation , the half of the scar treated with the suture had a better outcome ( mean=3.50 ) relative to tissue adhesive ( mean=2.75 ) ( P<.05 ) . All other variables ( i.e. , scar thickness , wound approximation , patient outcome , and preference ) were highly equivalent . CONCLUSION Both rapid absorbing gut suture and tissue adhesive appear to be highly efficacious techniques for epidermal closure . It appears that tissue adhesive may not be as effective in achieving optimal cosmesis for defects after Mohs micrographic surgery on the trunk and extremities in follow-up at 3 months Traditional skin sutures ( TSS ) and metal skin clips ( SC ) are the most common devices utilized for closure of surgical incisions . They are safe and effective , although they require instruments to apply them , are time consuming and , above all , create an extra staff and cost burden for removal of sutures/staples . The ideal incision closure should be simple , effective , safe , rapid , inexpensive , painless , cosmetic and bactericidal . The present study was design ed to determine the safety and efficacy of N-butyl octyl cyanoacrylate ( NCA ) tissue adhesive , a liquid b and age surgical product , for wound closure in brain surgery . Our prospect i ve r and omized controlled study compared NCA with traditional methods for wound closure in brain surgery . Over a 6-month period , 40 patients who underwent a supratentorial elective craniotomy were enrolled and r and omly allocated into two groups . The 20 participants in group A were treated using a new NCA tissue adhesive while the 20 participants in group B were treated using either nylon monofilament , TSS or SC . In the post-operative period and during follow-up , two different nurses ( the second nurse was blinded to the closure method used ) recorded details regarding wound aspects , complications and patient satisfaction using a modified version of the Holl and er Wound Score Scale . We found no difference in the cosmetic outcome of the two groups , or in wound complications rate , but the patient satisfaction score was higher in group A ( 9.4 vs. 7.1 ; p<0.005 ) . The mean application time of the tissue adhesive was significantly faster than that of the st and ard suture ( 115s vs. 300s ; p<0.001 ) ; in the skin clips subgroup it was 105s . Our study suggests that the new NCA tissue adhesive is a safe , effective and reliable skin closure for neurosurgical procedures in the supratentorial region ; it also achieves optimal cosmetic results , is less time consuming to use and has greater patient satisfaction . However , further studies with a larger number of patients are necessary to corroborate these results OBJECTIVE To compare the surgical efficacy and wound-healing characteristics of the tissue adhesive octyl-2-cyanoacrylate ( approved by the Food and Drug Administration ) with traditional suture closure in upper blepharoplasty . METHODS Prospect i ve , r and omized , blinded study comparing cosmetic and functional outcome and time efficiency . Twenty subjects underwent upper eyelid blepharoplasty . Each patient had a control side and an experimental side determined r and omly . One eyelid incision was closed with octyl-2-cyanoacrylate ( Dermabond ; Ethicon Inc , Somerville , NJ ) tissue glue , and the other with 6.0 suture ( polypropylene or fast-absorbing gut ) . Comparisons were performed for the time for closure by each method , wound healing , and patient satisfaction . Macrophotographs of the wounds at 1 , 2 , and 4 weeks after surgery were grade d by 5 observers blinded to the closure method , using a 10-point scale and a modified Holl and er wound evaluation scale . RESULTS No statistically significant difference was found between the quality of octyl-2-cyanoacrylate closure and suture closure at 1 month . There were no differences in wound complications , duration of healing , inflammation , or final incision appearance . By 2 weeks , the sides were indistinguishable in 15 ( 75 % ) of the patients . Time for closure averaged 7 minutes with suture and 8 minutes with glue . CONCLUSIONS Octyl-2-cyanoacrylate glue is an excellent alternative to suture closure , producing equivalent quality of closure at all time points and no difference in appearance . This adhesive was sufficient to withst and the forces of closure in upper eyelid blepharoplasty without dehiscence in the absence of sutures BACKGROUND Topical 2-octylcyanoacrylate tissue adhesive is an alternative to traditional devices for closing short surgical incisions . METHODS An open-label , r and omized study compared a new high-viscosity formulation of 2-octylcyanoacrylate with commercially available devices , including low-viscosity 2-octylcyanoacrylate , for epidermal closure of incisions > or = 4 cm requiring subcutaneous and /or deep-dermal suturing . RESULTS Of patients with 1 to 3 wounds , 106 were treated with high-viscosity 2-octylcyanoacrylate and 103 with commercially available devices . The day-10 rates of healing by wound were 96 % and 97 % for study versus control treatment and 97 % and 95 % for new and old 2-octylcyanoacrylate formulations versus other controls , respectively . Day-10 infection rates by wound were 4 of 145 versus 7 of 131 for study versus control treatment and 6 of 207 and 5 of 69 for new and old 2-octylcyanoacrylate versus other controls , respectively . CONCLUSIONS The new tissue adhesive formulation provides epidermal wound closure equivalent to commercially available devices with a trend to decreased incidence of wound infection STUDY OBJECTIVE To compare the 1-year cosmetic outcome of wounds treated with octylcyanoacrylate tissue adhesive and monofilament sutures and to correlate the early , 3-month , and 1-year cosmetic outcomes . METHODS We prospect ively r and omized 136 cases of traumatic laceration to repair with octylcyanoacrylate tissue adhesive or 5 - 0 or smaller monofilament suture . A wound score was assigned by a research nurse , and vali date d by a second nurse blinded to the treatment , at 5 to 10 days after injury ( early ) , 3 months , and 1 year . St and ardized photographs were taken at 3 months and 1 year and shown to a cosmetic surgeon blinded to the method of closure , who rated the wounds on a vali date d cosmesis scale . RESULTS We were able to examine 77 lacerations at 1 year for follow-up . No differences were found in the demographic or clinical characteristics between groups . Likewise , at 1 year no difference was found in the optimal wound scores ( 73 % versus 68 % , P = .60 ) or in visual analog scale cosmesis scores ( 69 versus 69 mm , P = .95 ) for octylcyanoacrylate and sutures , respectively . Agreement was poor between early and 3-month wound scores ( kappa=.34 ; 95 % confidence interval [CI],.10 to.58 ) but a strong association existed between 3-month and 1-year wound scores ( kappa=.71 ; 95 % CI,.52 to.90 ) . We noted a moderate correlation between 3-month and 1-year results on the visual analog cosmesis scale ( intraclass correlation,.48 ; 95 % CI , .30 to.63 ) . CONCLUSION One year after wound repair , no difference is noted in the cosmetic outcomes of traumatic lacerations treated with octylcyanoacrylate tissue adhesive and sutures . The assessment of wounds 3 months after injury and wound repair provides a good measure of long-term cosmetic outcome BACKGROUND Wound closure devices include sutures , tissue adhesives , adhesive strips , and staples . Recent studies suggest no differences between various tissue adhesives and sutures for dehiscence , infection , and satisfaction when assessed by patients or surgeons . To date , no studies have investigated ClozeX ( Clozex Medical LLC , Wellesley , MA , USA ) , a novel adhesive strip , for closure of surgical incisions . OBJECTIVE To compare surgical wounds repaired with ClozeX versus suture . METHODS A prospect i ve , r and omized study was conducted , in which 15 patients with surgical incisions were allocated to closure with ClozeX on half of the wound and monofilament suture on the other half . Physician satisfaction with blinded assessment , patient satisfaction , complication rates , and closure times were recorded . RESULTS Application with ClozeX was faster than with suture ( p=.007 ) . There were no complications in either group . Sixty-nine percent of the patients gave ClozeX a higher satisfaction score ( p=.02 ) . More physicians were satisfied with the ClozeX half than with the suture half ( p=.007 ) . CONCLUSIONS This pilot study demonstrates ClozeX to be a safe and effective closure device . The cosmetic outcome seems to be at least as good as simple running suture . Physicians and patients were generally more satisfied with ClozeX. No difference was found in the rate of dehiscence or infection between the groups A r and om study for management of wound by cyanoacrylate glue in 213 patients , irrespective of age and sex with different types of wounds was carried out over a period of 4 years ( 1996 - 2000 ) . In this series both dean surgical wounds and infected accidental wounds were included . Most of the patients recovered uneventfully , except 5 , who showed wound gap . Reapplication of glue was done on them and 3 had similar wound union but 2 patients ( 0.94 % ) required surgical suture Background Topical 2-octylcyanoacrylate tissue ( OCA ) adhesive has been used as an alternative to close wounds with a comparable cosmetic outcome . The use of 2-OCA in the closure of abdominal laparotomy wounds has not been thoroughly evaluated . Our aim was to compare 2-OCA with conventional skin stapling devices in colorectal surgery . Methods A prospect i ve r and omised study was conducted in which 74 consecutive patients above the age of 21 undergoing open elective colectomies for benign or malignant indications were allocated to skin closure with 2-OCA or skin staples . Cosmetic outcome as assessed with the Holl and er Cosmesis Scale with a single assessor , complication rates , and patient satisfaction were recorded at discharge ( 4–10POD ) 2 weeks after discharge and then at 3 months . Results Of the 74 patients , 38 were r and omised to skin staples and 36 to 2-OCA . There was no significant difference in cosmetic outcomes between the two groups as assessed with a visual analogue scale or the Holl and er Cosmesis Scale but showed a trend to better cosmetic outcomes in the 2-OCA group . Patient satisfaction scores were higher but did not reach statistical significance . The time taken to close a wound with 2-OCA was significantly longer than with skin staples . There was no statistical difference in rates of wound infection . Conclusion 2-OCA is a safe and effective means of skin closure in patients undergoing elective colectomies with a good and at least equivalent outcome to traditional methods of closure PURPOSE In this study , we compared the skin adhesive 2-octylcyanoacrylate to subcuticular suture for closure of pediatric inguinal hernia incisions to determine if skin adhesive improves wound cosmesis , shortens skin closure time , and lowers operative costs . METHODS We prospect ively r and omized 134 children undergoing inguinal herniorrhaphy at our institution to have skin closure with either skin adhesive ( n = 64 ) or subcuticular closure ( n = 70 ) . Data collected included age , sex , weight , type of operation , total operative time , and skin closure time . Digital photographs of healing incisions were taken at the 6-week postoperative visit . The operating surgeon assessed cosmetic outcome of incisions using a previously vali date d visual analog scale , as well as an ordinate scale . A blinded assessment of cosmetic outcome was then performed by an independent surgeon comparing these photographs to the visual analog scale . Operating room time and re source use ( ie , costs ) relative to the skin closure were assessed . Comparisons between groups were done using Student 's t tests and chi(2 ) tests . RESULTS Children enrolled in the study had a mean + /- SE age of 3.7 + /- 0.3 years and weighed 16 + /- 0.8 kg . Patients were predominantly male ( 82 % ) . Patients underwent 1 of 3 types of
Output:
| No evidence of differences was found between tissue adhesives and tapes for minimising dehiscence , infection , patients ' assessment of cosmetic appearance , patient satisfaction or surgeon satisfaction .
There appeared to be little difference in outcome for different types of tissue adhesives .
One study that compared high viscosity with low viscosity adhesives found that high viscosity adhesives were less time-consuming to use than low viscosity tissue adhesives , but the time difference was small .
Sutures are significantly better than tissue adhesives for minimising dehiscence .
In some cases tissue adhesives may be quicker to apply than sutures . |
MS212115 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Context : Denosumab 60 mg sc injection every 6 months for 36 months was well tolerated and effective in reducing the incidence of vertebral , nonvertebral , and hip fracture in predominantly Caucasian postmenopausal women with osteoporosis . Objective : The objective of this phase 3 fracture study was to examine the antifracture efficacy and safety of denosumab 60 mg in Japanese women and men with osteoporosis compared with placebo . Design and Setting : A r and omized , double-blind , placebo-controlled trial with an open-label active comparator as a referential arm was conducted . Patients : Subjects were 1262 Japanese patients with osteoporosis aged 50 years or older , who had one to four prevalent vertebral fractures . Intervention : Subjects were r and omly assigned to receive denosumab 60 mg sc every 6 months ( n = 500 ) , placebo for denosumab ( n = 511 ) , or oral alendronate 35 mg weekly ( n = 251 ) . All subjects received daily supplements of calcium and vitamin D. Main Outcome Measure : The primary endpoint was the 24-month incidence of new or worsening vertebral fracture for denosumab vs placebo . Results : Denosumab significantly reduced the risk of new or worsening vertebral fracture by 65.7 % , with incidences of 3.6 % in denosumab and 10.3 % in placebo at 24 months ( hazard ratio 0.343 ; 95 % confidence interval 0.194–0.606 , P = .0001 ) . No apparent difference in adverse events was found between denosumab and placebo during the first 24 months of the study . Conclusion : These results provide evidence of the efficacy and safety of denosumab 60 mg sc every 6 months in Japanese subjects with osteoporosis CONTEXT Denosumab is an investigational fully human monoclonal antibody against receptor activator of nuclear factor-kappaB lig and , a mediator of osteoclastogenesis and osteoclast survival . OBJECTIVE This study evaluated the ability of denosumab to increase bone mineral density ( BMD ) and decrease bone turnover markers ( BTMs ) in early and later postmenopausal women with low BMD . DESIGN AND SETTING This 2-yr r and omized , double-blind , placebo-controlled study was conducted in North America . PARTICIPANTS Subjects included 332 postmenopausal women with lumbar spine BMD T-scores between -1.0 and -2.5 . INTERVENTIONS SUBJECTS were r and omly assigned to receive denosumab sc , 60 mg every 6 months , or placebo . R and omization was stratified by time since onset of menopause ( < or = 5 yr or > 5 yr ) . MAIN OUTCOME MEASURES The primary end point was the percent change in lumbar spine BMD by dual-energy x-ray absorptiometry at 24 months . Additional end points were percent change in volumetric BMD of the distal radius by quantitative computed tomography ; percent change in BMD by dual-energy x-ray absorptiometry for the total hip , one-third radius , and total body ; hip structural analysis ; percent change in BTMs ; and safety . RESULTS Denosumab significantly increased lumbar spine BMD , compared with placebo at 24 months ( 6.5 vs. -0.6 % ; P<0.0001 ) with similar results for both strata . Denosumab also produced significant increases in BMD at the total hip , one-third radius , and total body ( P < 0.0001 vs. placebo ) ; increased distal radius volumetric BMD ( P < 0.01 ) ; improved hip structural analysis parameters ; and significantly suppressed serum C-telopeptide , tartrate-resistant acid phosphatase-5b , and intact N-terminal propeptide of type 1 procollagen . The overall incidence of adverse events was similar between both study groups . CONCLUSIONS Twice-yearly denosumab increased BMD and decreased BTMs in early and later postmenopausal women CONTEXT For many patients , adhering to postmenopausal osteoporosis treatment is a challenge . Higher treatment satisfaction is associated with greater persistence with these therapies , which is associated with better outcomes . OBJECTIVE This study aim ed to evaluate the change in treatment satisfaction in postmenopausal women who were suboptimally adherent to daily or weekly oral bisphosphonates and who transitioned to denosumab vs a monthly oral bisphosphonate . DESIGN AND SETTING Pooled data of out patients from two international , multicenter , r and omized , open-label studies were analyzed . PATIENTS Postmenopausal women ( n = 1703 ) age 55 years or greater with low bone mineral density who were suboptimally adherent with prior oral bisphosphonate therapy , as assessed by the Osteoporosis-Specific Morisky Medication Adherence Scale , were included in the study . INTERVENTIONS Patients received denosumab , a fully human monoclonal antibody to receptor activator of nuclear factor-kappa B lig and , 60 mg s.c . every 6 months vs the oral bisphosphonates ib and ronate or risedronate , 150 mg once monthly for 12 months . MAIN OUTCOME MEASURES Change in treatment satisfaction scores from baseline to months 6 and 12 were measured using the Treatment Satisfaction Question naire for Medication ( TSQM ) . The TSQM is a vali date d tool that measures perception of four domains of treatment satisfaction : effectiveness , side effects , convenience , and global satisfaction . RESULTS Patients in both treatment groups showed improvement from baseline for all four TSQM domains at 6 and 12 months . However , the denosumab group had significantly ( all P < .001 ) greater improvements among all four TSQM domains at 6 and 12 months compared with the oral bisphosphonate group . CONCLUSIONS Women with low adherence to oral bisphosphonates reported greater treatment satisfaction when transitioned to denosumab vs switching to a monthly oral bisphosphonate INTRODUCTION Denosumab is a fully human monoclonal antibody that inhibits receptor activator of nuclear factor-kappa B lig and ( RANKL ) , an essential mediator of osteoclast formation , function , and survival that has been shown to decrease bone turnover and increase bone mineral density ( BMD ) in treated patients . We assessed the long-term efficacy and safety of denosumab , and the effects of discontinuing and restarting denosumab treatment in postmenopausal women with low bone mass . METHODS Postmenopausal women with a lumbar spine T-score of -1.8 to -4.0 or proximal femur T-score of -1.8 to -3.5 were r and omized to denosumab every 3 months ( Q3 M ; 6 , 14 , or 30 mg ) or every 6 months ( Q6 M ; 14 , 60 , 100 , or 210 mg ) ; placebo ; or open-label oral alendronate weekly . After 24 months , patients receiving denosumab either continued treatment at 60 mg Q6 M for an additional 24 months , discontinued therapy , or discontinued treatment for 12 months then re-initiated denosumab ( 60 mg Q6 M ) for 12 months . The placebo cohort was maintained . Alendronate-treated patients discontinued alendronate and were followed . Changes in BMD and bone turnover markers ( BTM ) as well as safety outcomes were evaluated . RESULTS Overall , 262/412 ( 64 % ) patients completed 48 months of study . Continuous , long-term denosumab treatment increased BMD at the lumbar spine ( 9.4 % to 11.8 % ) and total hip ( 4.0 % to 6.1 % ) . BTM were consistently suppressed over 48 months . Discontinuation of denosumab was associated with a BMD decrease of 6.6 % at the lumbar spine and 5.3 % at the total hip within the first 12 months of treatment discontinuation . Retreatment with denosumab increased lumbar spine BMD by 9.0 % from original baseline values . Levels of BTM increased upon discontinuation and decreased with retreatment . Adverse event rates were similar among treatment groups . CONCLUSIONS In postmenopausal women with low BMD , long-term denosumab treatment led to gains in BMD and reduction of BTM throughout the course of the study . The effects on bone turnover were fully reversible with discontinuation and restored with subsequent retreatment OBJECTIVE : To compare the efficacy and safety of denosumab to ib and ronate in postmenopausal women with low bone mineral density ( BMD ) previously treated with a bisphosphonate . METHODS : In a r and omized , open-label study , postmenopausal women received 60 mg denosumab subcutaneously every 6 months ( n=417 ) or 150 mg ib and ronate orally every month ( n=416 ) for 12 months . End points included percentage change from baseline in total hip , femoral neck , and lumbar spine BMD at month 12 and percentage change from baseline in serum C-telopeptide at months 1 and 6 in a sub study . RESULTS : At month 12 , significantly greater BMD gains from baseline were observed with denosumab compared with ib and ronate at the total hip ( 2.3 % compared with 1.1 % ) , femoral neck ( 1.7 % compared with 0.7 % ) , and lumbar spine ( 4.1 % compared with 2.0 % ; treatment difference P<.001 at all sites ) . At month 1 , median change in serum C-telopeptide from baseline was −81.1 % with denosumab and –35.0 % with ib and ronate ( P<.001 ) ; the treatment difference remained significant at month 6 ( P<.001 ) . Adverse events occurred in 245 ( 59.6 % ) denosumab-treated women and 230 ( 56.1 % ) ib and ronate-treated women ( P=.635 ) . The incidence of serious adverse events was 9.5 % for denosumab-treated women and 5.4 % for ib and ronate-treated women ( P=.046 ) . No clustering of events in any organ system accounted for the preponderance of these reports . The incidence rates of serious adverse events involving infection and malignancy were similar between treatment groups . CONCLUSION : In postmenopausal women previously treated with a bisphosphonate and low BMD , denosumab treatment result ed in greater BMD increases than ib and ronate at all measured sites . No new safety risks with denosumab treatment were identified . CLINICAL TRIAL REGISTRATION : Clinical Trials.gov , www . clinical trials.gov , NCT00936897 . LEVEL OF EVIDENCE : BACKGROUND Receptor activator of nuclear factor-kappaB lig and ( RANKL ) is essential for osteoclast differentiation , activation , and survival . The fully human monoclonal antibody denosumab ( formerly known as AMG 162 ) binds RANKL with high affinity and specificity and inhibits RANKL action . METHODS The efficacy and safety of subcutaneously administered denosumab were evaluated over a period of 12 months in 412 postmenopausal women with low bone mineral density ( T score of -1.8 to -4.0 at the lumbar spine or -1.8 to -3.5 at the proximal femur ) . Subjects were r and omly assigned to receive denosumab either every three months ( at a dose of 6 , 14 , or 30 mg ) or every six months ( at a dose of 14 , 60 , 100 , or 210 mg ) , open-label oral alendronate once weekly ( at a dose of 70 mg ) , or placebo . The primary end point was the percentage change from baseline in bone mineral density at the lumbar spine at 12 months . Changes in bone turnover were assessed by measurement of serum and urine telopeptides and bone-specific alkaline phosphatase . RESULTS Denosumab treatment for 12 months result ed in an increase in bone mineral density at the lumbar spine of 3.0 to 6.7 percent ( as compared with an increase of 4.6 percent with alendronate and a loss of 0.8 percent with placebo ) , at the total hip of 1.9 to 3.6 percent ( as compared with an increase of 2.1 percent with alendronate and a loss of 0.6 percent with placebo ) , and at the distal third of the radius of 0.4 to 1.3 percent ( as compared with decreases of 0.5 percent with alendronate and 2.0 percent with placebo ) . Near-maximal reductions in mean levels of serum C-telopeptide from baseline were evident three days after the administration of denosumab . The duration of the suppression of bone turnover appeared to be dose-dependent . CONCLUSIONS In postmenopausal women with low bone mass , denosumab increased bone mineral density and decreased bone resorption . These preliminary data suggest that denosumab might be an effective treatment for osteoporosis . ( Clinical Trials.gov number , NCT
Output:
| CONCLUSION Denosumab can be used both as a first-line agent and an alternative to bisphosphonate in the treatment of postmenopausal osteoporosis .
There is currently insufficient data to show that denosumab is not inferior to bisphosphonates in fracture prevention |
MS212116 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Background : Cognitive decline leads to disability and increased health care expenditures . Methods : Effectiveness of an intervention to stimulate multiple cognitive domains was determined using a format combining traditional and computer-based activities ( Integrated Cognitive Stimulation and Training Program ) , 45 minutes a day , 2 days a week , for 6 weeks . Nonimpaired , mildly , and moderately-impaired participants > age 65 ( n = 32 ) were r and omly allocated into a control or experimental group . Using a repeated measures design participants were tested again postintervention and at 8 weeks follow-up . Results : Statistically significant improvement on Dementia Rating Scale scores occurred for mildly and moderately impaired treatment participants ( n = 15 ) . Statistical significance was demonstrated on subscales of the WMS-III : Logical Memory I and Logical Memory II . Conclusion : Blending computer-based with traditional cognitive stimulation activities shows promise in preserving cognitive function in elders . Future studies to explore efficacy in larger , more diverse sample s are needed Background Errorless learning ( EL ) is a method for optimizing learning , which uses feed-forward instructions in order to prevent people from making mistakes during the learning process . The majority of previous studies on EL taught patients with dementia artificial tasks of little or no relevance for their daily lives . Furthermore , only a few controlled studies on EL have so far been performed and just a h and ful of studies have examined the long-term effects of EL . Tasks were not always trained in the patients ’ natural or home environment , limiting the external validity of these studies . This multicenter parallel r and omized controlled trial examines the effects of EL compared with trial and error learning ( TEL ) on the performance of activities of daily living in persons with Alzheimer ’s or mixed-type dementia living at home . Methods Patients received nine 1-hour task training sessions over eight weeks using EL or TEL . Task performance was measured using video observations at week 16 . Secondary outcome measures were task performance measured at week 26 , satisfaction with treatment , need for assistance , challenging behavior , adverse events , re source utilization and treatment costs . Results A total of 161 participants were r and omized , of whom 71 completed the EL and 74 the TEL arm at week 11 . Sixty-nine EL patients and 71 TEL patients were assessed at the 16-week follow-up ( the primary measurement endpoint ) . Intention-to-treat analysis showed a significantly improved task performance in both groups . No significant differences between the treatment groups were found for primary or secondary outcomes . Conclusions Structured relearning improved the performance of activities of daily living . Improvements were maintained for 6 months . EL had no additional effect over TEL.Trial registration German Register of Clinical Trials DRKS00003117 . Registered 31 May 2011 [ Purpose ] The purpose of this study was to investigate the effect of cognitive rehabilitation including tasks of cognitive training on performance of everyday activities in elderly people with early-stage Alzheimer ’s disease . [ Subjects and Methods ] Forty-three elderly people ( 15 men , 28 women ) with a diagnosis of Alzheimer ’s disease who had a Mini-Mental State Examination ( MMSE ) score of 18 or above were r and omly assigned to two groups : the cognitive rehabilitation group ( experimental ) and control group . This study used a r and omized controlled trial design . Cognitive rehabilitation is consisted of 8 sessions , each lasting 60 minutes ( individual 30 min , group 30 min ) . The eight weekly individual sessions of cognitive rehabilitation were performed consisting of an individualized intervention focusing on a personally meaningful goal . The eight weekly group sessions involved practicing time- and -place orientation , matching faces and names , and learning memory and sustaining attention . [ Results ] Significant improvements were observed in rating of occupation performance and satisfaction , Quality of Life in Alzheimer ’s Disease ( QOL-AD ) , and the orientation subscale of the MMSE in the experimental group , whereas participants in the control group did not show any significant difference in any tests between before and after the intervention . [ Conclusion ] Cognitive rehabilitation including tasks of cognitive training is an effective intervention for improving performance and satisfaction with respect to activities of daily living and specific cognitive functions BACKGROUND Increasing evidence demonstrates the efficacy of cognitive stimulation ( CS ) in individuals with dementia . However , conducting studies in nursing homes engenders specific challenges that have limited the data gathered on this topic so far . OBJECTIVE The aim of this r and omized controlled trial was to investigate the effects of CS on cognition , quality of life ( QoL ) , behavioral symptoms , and activities of daily life in persons with dementia living in nursing homes . We further aim ed to identify predictors of the intervention 's benefits . METHODS Seventy-one persons with mild to moderate dementia were r and omly allocated to the experimental group ( EG ; n = 36 ) that visited a CS program twice weekly for eight weeks or to the control group ( CG ; n = 35 ) that was receiving usual care . Neuropsychological tests were conducted before and after the intervention period and at six-week follow-up . RESULTS There were no significant interaction effects Time × Group for the outcome measures . However , regression analysis revealed that a low cognitive baseline level predicted cognitive improvements . Furthermore , a low baseline level of QoL predicted a QoL benefit . For both findings , depression was a significant moderator , meaning that persons with fewer depressive symptoms had a higher probability of showing improvements . CONCLUSION This study provides data on profiles of patients who are most likely to profit from CS intervention in nursing-home setting s and demonstrates that treatment of depression is of the utmost relevance for a positive outcome of CS . Living conditions will have to be considered more thoroughly in future research The purpose of this study was to examine the beneficial effects of a new cognitive intervention program design ed for the care and prevention of dementia , namely Learning Therapy . The training program used systematized basic problems in arithmetic and Japanese language as training tasks . In study 1 , 16 individuals in the experimental group and 16 in the control group were recruited from a nursing home . In both groups , all individuals were clinical ly diagnosed with senile dementia of the Alzheimer type . In study 2 , we performed a single-blind , r and omized controlled trial in our cognitive intervention program of 124 community-dwelling seniors . In both studies , the daily training program using reading and arithmetic tasks was carried out approximately 5 days a week , for 15 to 20 minutes a day in the intervention groups . Neuropsychological measures were determined simultaneously in the groups both prior to and after six months of the intervention . The results of our investigations indicate that our cognitive intervention using reading and arithmetic problems demonstrated a transfer effect and they provide convincing evidence that cognitive training maintains and improves the cognitive functions of dementia patients and healthy seniors OBJECTIVE This study evaluates the efficacy at 12 months of a computer-based cognitive training ( CBCT ) program , adjunctive to traditional cognitive training ( TCT ) , on the basis of pen- and -paper exercises . METHODS Sixty patients with multi-domain mild cognitive impairment and mild Alzheimer 's disease who were already receiving cognitive training , recruited from a day hospital , were assigned into two groups following a simple r and omization procedure ( computerized r and om numbers ) : ( i ) a group that received CBCT during 3 months and TCT ( CBCT + TCT ) , n = 37 , and ( ii ) a group that received only TCT , n = 23 . Patients were assessed at baseline and after 3 and 12 months of treatment by a neuropsychologist blinded to group assignment , with a neuropsychological battery ( primary outcomes ) and measures of decision making , memory complaints , and emotional disturbances . RESULTS With the use of repeated- measures analyses of covariance , the CBCT + TCT group showed less anxiety symptoms ( F = 5.13 , p = 0.03 , d = 1.12 ) and less disadvantageous choices ( F = 4.70 , p = 0.04 , d = 0.89 ) in decision making than the TCT group at 12 months . No significant improvement or worsening was observed in the other measures examined . However , positive effect sizes favoring the CBCT + TCT group were observed in all variables . CONCLUSIONS The addition of a CBCT program was effective in anxiety and decision making but had no significant effects on outcomes in basic cognitive functions in patients who were already receiving cognitive training , possibly due to a ceiling effect . Future studies should compare the efficacy of CBCT with TCT in naïve patients Background Interventions that improve cognitive function in Alzheimer 's disease are urgently required . Aims To assess whether a novel cognitive training paradigm based on ‘ chunking ’ improves working memory and general cognitive function , and is associated with reorganisation of functional activity in prefrontal and parietal cortices ( trial registration : IS RCT N43007027 ) . Method Thirty patients with mild Alzheimer 's disease were r and omly allocated to receive 18 sessions of 30 min of either adaptive chunking training or an active control intervention over approximately 8 weeks . Pre- and post-intervention functional magnetic resonance imaging ( fMRI ) scans were also conducted . Results Adaptive chunking training led to significant improvements in verbal working memory and untrained clinical measures of general cognitive function . Further , fMRI revealed a bilateral reduction in task-related lateral prefrontal and parietal cortex activation in the training group compared with controls . Conclusions Chunking-based cognitive training is a simple and potentially scalable intervention to improve cognitive function in early Alzheimer 's disease We developed and evaluated the effect of Multimodal Cognitive Enhancement Therapy ( MCET ) consisting of cognitive training , cognitive stimulations , reality orientation , physical therapy , reminiscence therapy , and music therapy in combination in older people with mild cognitive impairment ( MCI ) or mild dementia . This study was a multi-center , double-blind , r and omized , placebo-controlled , two-period cross-over study ( two 8-week treatment phases separated by a 4-week wash-out period ) . Sixty-four participants with MCI or dementia whose Clinical Dementia Rating was 0.5 or 1 were r and omized to the MCET group or the mock-therapy ( placebo ) group . Outcomes were measured at baseline , week 9 , and week 21 . Fifty-five patients completed the study . Mini-Mental State Examination ( effect size = 0.47 , p = 0.013 ) and Alzheimer 's Disease Assessment Scale-Cognitive Subscale ( effect size = 0.35 , p = 0.045 ) scores were significantly improved in the MCET compared with mock-therapy group . Revised Memory and Behavior Problems Checklist frequency ( effect size = 0.38 , p = 0.046 ) and self-rated Quality of Life - Alzheimer 's Disease ( effect size = 0.39 , p = 0.047 ) scores were significantly improved in the MCET compared with mock-therapy . MCET improved cognition , behavior , and quality of life in people with MCI or mild dementia more effectively than conventional cognitive enhancing activities did BACKGROUND Cognitive Rehabilitation for Alzheimer 's disease ( AD ) is an integrative multimodal intervention . It aims to maintain autonomy and quality of life by enhancing the patients ' abilities to compensate for decreased cognitive functioning . OBJECTIVE We evaluated the feasibility of a group-based Cognitive Rehabilitation approach in mild AD dementia and assessed its effect on activities of daily living ( ADL ) . METHODS We included 16 patients with AD dementia in a controlled partial-r and omized design . We adapted the manual-guided Cognitive Rehabilitation program ( CORDIAL ) to a group setting . Over the course of three months , one group received the Cognitive Rehabilitation intervention ( n = 8) , while the other group received a st and ardized Cognitive Training as an active control condition ( n = 8) . ADL-competence was measured as primary outcome . The secondary outcome parameters included cognitive abilities related to daily living , functional cognitive state , and non-cognitive domains , e.g. , quality of life . For each scale , we assessed the interaction effect ' intervention by time ' , i.e. , from pre-to post-intervention . RESULTS We found no significant interaction effect of intervention by time on the primary outcome ADL-competence . The interaction effect was significant for quality of life ( Cohen 's d : -1.43 ) , showing an increase in the intervention group compared with the control group . CONCLUSIONS Our study demonstrates the feasibility of a group-based Cognitive Rehabilitation program for patients with mild AD dementia . The Cognitive Rehabilitation showed no significant effect on ADL , possibly reflecting a lack of transfer between the therapy setting and real life . However , the group setting enhanced communication skills and coping mechanisms . Effects on ADL may not have reached statistical significance due to a limited sample size . Furthermore , future studies might use an extended duration of the intervention and integrate caregivers to a greater extent to increase transfer to activities of daily living Background : Cognitive rehabilitation ( CR ) is a cognitive intervention for patients with Alzheimer ’s disease ( AD ) that aims to maintain everyday competences . The analysis of functional connectivity ( FC ) in resting-state functional MRI has been used to investigate the effects of cognitive interventions . Objectives : We evaluated the effect of CR on the default mode network FC in a group of patients with mild AD , compared to an active control group . Methods : We performed a three-month interventional study including 16 patients with a diagnosis of AD . The intervention group ( IG ) consisted of eight patients , performing twelve sessions of CR . The active control group ( CG ) performed a st and ardized cognitive training . We used a seed region placed in the posterior cingulate cortex ( PCC ) for FC analysis , comparing scans acquired before and after the intervention . Effects were thresholded at a significance of p < 0.001 ( uncorrected ) and a minimal cluster size of 50 voxels . Results : The interaction of group by time showed a higher increase
Output:
| In relation to many other outcomes , including our second primary outcome of clinical disease severity in the medium term , the quality of evidence was very low , so we were unable to determine whether CT was associated with any meaningful gains .
The quality of evidence in relation to many other outcomes at end of treatment and in the medium term was too low for us to determine whether CT was associated with any gains , but we are moderately confident that CT did not lead to any gains in mood , behavioural and psychological symptoms , or capacity to perform activities of daily living .
AUTHORS ' CONCLUSIONS Relative to a control intervention , but not to a variety of alternative treatments , CT is probably associated with small to moderate positive effects on global cognition and verbal semantic fluency at end of treatment , and these benefits appear to be maintained in the medium term . |
MS212117 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: OBJECTIVES A high prevalence of hip and other fractures in elderly patients with Parkinson ’s disease has been linked to reduced bone mass arising from a defect of renal synthesis of 1 , 25-dihydroxyvitamin D ( 1 , 25-[OH]2D ) . Treatment with 1α-hydroxyvitamin D3 ( 1α(OH)D3 ; an active form of vitamin D ) was evaluated for maintaining bone mass and reducing the incidence of hip and other non-vertebral fractures in patients with Parkinson ’s disease . METHODS In a double blind , r and omised trial , 86 elderly patients with Parkinson ’s disease ( mean Hoehn and Yahr stage , 3 ; mean age 70.6 years ) were r and omised to receive either 1 μg 1α(OH)D3 daily ( treatment group , n=43 ) or a placebo ( n=43 ) for 18 months . Bone mineral densities in the second metacarpals were determined by computed radiographic densitometry . Serum bone turnover indices were measured serially , and incidence of non-vertebral fractures was recorded . RESULTS Bone mineral densities decreased 1.2 % in the treatment group compared with 6.7 % in the placebo group during 18 months ( p<0.0001 ) . At baseline in both groups , the serum concentration of 1 , 25-[OH]2D was reduced . Parathyroid hormone was abnormally increased in 15 patients ( 17 % ) and correlated negatively with serum 25-hydroxyvitamin D , indicating compensatory hyperparathyroidism . Eight patients sustained fractures ( six at the hip and two at other sites ) in the placebo group , and one hip fracture occurred among treated patients ( odds ratio 9.8 ; p=0.0028 ) . CONCLUSION By increasing serum 1 , 25-[OH]2D concentrations , treatment with 1α(OH)D3 can reduce the risk of hip and other non-vertebral fractures in osteoporotic elderly patients with Parkinson ’s disease by slowing the loss of bone mineral densities Objectives : To assess the effectiveness of a multivitamin ( MV ) tablet on nutritional status , quantitative heel ultrasound ( QUS ) , mobility , muscle strength and falls . The design comprised two groups matched on mobility levels , r and omized to receive a daily MV or placebo ( P ) tablet for 6 months . The setting was an Australian residential care facility . Subjects : A total of 92 aged care residents . Serum micronutrients , body weight , QUS , rate of falls , h and grip strength , and the timed up and go test were assessed at baseline and 6 months . Results : A total of 49 participants consumed a MV and 43 , a matched P for 6 months . There was a greater increase in the MV vs P group for serum 25(OH)D ( mean difference±st and ard error , 33.4±2.6 nmol l−1 ) , folate ( 13.4±2.8 nmol l−1 ) , and vitamin B12 ( 178.0±40.3 pmol l−1 ) ( all P<0.001 ) . Adequate 25(OH)D concentrations ( ⩾50 nmol l−1 ) were found among 77 % of participants in the MV group vs 10 % taking P ( P<0.001 ) . Adjusting for baseline levels , the increase in QUS was greater in the MV vs P group ( 3.0±2.0 dB MHz−1 vs −2.9±2.1 dB MHz−1 , respectively , P=0.041 ) . There was a trend towards a 63 % lower mean number of falls in the MV vs P group ( 0.3±0.1 falls vs 0.8±0.3 falls , P=0.078 ) . Conclusions : MV supplementation raised serum vitamin B12 and folate concentrations and increased serum 25(OH)D , which was accompanied by an apparent positive effect on bone density . We also found a trend towards a reduction in falls and this could contribute to a reduction in fractures The National Institutes of Health 's consensus conference ( 1 ) defined osteoporosis as a skeletal disorder characterized by compromised bone strength predisposing to an increased risk for fracture . Bone strength reflects the integration of two main features : bone density and bone quality .Bone quality refers to architecture , turnover , damage accumulation ( e.g. , microfractures ) , and mineralization . Although osteoporosis can affect any bone , the hip , spine , and wrist are most likely to be affected . Osteoporosis affects an estimated 44 million Americans or 55 % of people 50 years of age or older . Another 34 million Americans are estimated to have low bone mass , meaning that they are at an increased risk for osteoporosis . Osteoporosis can be diagnosed by the occurrence of fragility fracture . In patients without fragility fracture , osteoporosis is often diagnosed by low bone density . Dual x-ray absorptiometry ( DXA ) is the current gold st and ard test for diagnosing osteoporosis in people without an osteoporotic fracture . Dual x-ray absorptiometry results are scored as st and ard deviations ( SDs ) from a young healthy norm ( usually female ) and reported as T-scores . For example , a T-score of 2 indicates a bone mineral density that is 2 SDs below the comparative norm . The international reference st and ard for the description of osteoporosis in postmenopausal women and in men age 50 years or older is a femoral neck bone mineral density of 2.5 SD or more below the young female adult mean ( 2 ) . Low bone density , as measured by DXA , is an imperfect predictor of fracture risk , identifying fewer than half the people who go on to have an osteoporotic fracture . Screening guidelines for women are well established ( 3 ) , and the American College of Physicians ( ACP ) recently published guidelines on screening for men ( 4 ) . This guideline presents the available evidence on various pharmacologic treatments to prevent fractures in men and women with low bone density or osteoporosis . Medications used to treat osteoporosis may affect different parts of the skeletal system differently , and efficacy for vertebral fractures does not necessarily imply efficacy for nonvertebral fractures . The target audience for this guideline is all clinicians and the target patient population is all adult men and women with low bone density or osteoporosis . These recommendations are based on the systematic evidence review by MacLean and colleagues ( 5 ) and the Agency for Healthcare Research and Quality sponsored Southern California Evidence -Based Practice Center evidence report ( 6 ) . The drugs currently approved for prevention of osteoporosis include alendronate , ib and ronate , risedronate , zoledronic acid , estrogen , and raloxifene . The drugs currently approved for treatment of osteoporosis include alendronate , ib and ronate , risedronate , calcitonin , teriparatide , zoledronic acid ( in postmenopausal women ) , and raloxifene . Testosterone , pamidronate , and etidronate are not approved by the U.S. Food and Drug Administration for the treatment or prevention of osteoporosis . Methods The literature search done by MacLean and colleagues for the systematic review ( 5 ) included studies from MEDLINE ( 1966 to December 2006 ) , the ACP Journal Club data base , the Cochrane Central Register of Controlled Trials ( no date limits ) , the Cochrane Data base of Systematic Review s ( no date limits ) , Web sites of the United Kingdom National Institute of Health and Clinical Excellence ( no date limits ) , and the United Kingdom Health Technology Assessment Program ( January 1998 to December 2006 ) . The review ers limited their search to English- language publications and human studies . They derived evidence for comparative benefits of various treatments exclusively from r and omized , controlled trials , whereas they included evidence from other types of studies for short- and long-term harms . Two physicians independently abstract ed data about study population s , interventions , follow-up , and outcome ascertainment by using a structured form . For each group within a r and omized trial , a statistician extracted the sample size and number of persons reporting fractures . Two review ers , under the supervision of the statistician , independently abstract ed information about adverse events . The statistician or the principal investigator resolved disagreements . This guideline is based on an evaluation of 76 r and omized , controlled trials , 4 of which were identified in the up date d search , and 24 meta-analyses that were included in the efficacy analyses . The analyses of adverse events included 491 articles , representing 417 r and omized trials , 25 other controlled clinical trials , 11 open-label trials , 31 large observational studies , and 9 case reports of osteonecrosis among bisphosphonate users . MacLean and colleagues ' background article ( 5 ) includes details about the methods used for the systematic evidence review . The ACP rates the evidence and recommendations by using the Grading of Recommendations , Assessment , Development , and Evaluation ( GRADE ) system with minor modifications ( Table 1 ) . In addition , the evidence review ers used predefined criteria to assess the quality of systematic review s and r and omized trials , based on internal and external validity assessment s detailed in the Quality of Reporting of Meta-Analyses ( QUOROM ) statement ( 7 ) . Table 1 . The American College of Physicians ' Guideline Grading System The objective of this guideline is to synthesize the evidence for the following questions : What are the comparative benefits in fracture reduction among and also within the following treatments for low bone density : bisphosphonates , specifically alendronate , risedronate , etidronate , ib and ronate , pamidronate , and zoledronic acid ; calcitonin ; estrogen for women ; teriparatide ; selective estrogen receptor modulators ( SERMs ) , specifically raloxifene and tamoxifen ; testosterone for men ; vitamins and minerals , specifically vitamin D and calcium ; and the combination of calcium plus vitamin D ? How does fracture reduction result ing from treatments vary among individuals with different risks for fracture as determined by bone mineral density ( borderline , low , or severe ) , previous fractures ( prevention vs. treatment ) , age , sex , glucocorticoid use , and other factors ( such as community-dwelling vs. institutionalized or vitamin Ddeficient vs. not ) ? What are the short- and long-term harms ( adverse effects ) of these therapies , and do these vary by specific sub population s ? Comparative Benefits of Drugs versus Placebo in Fracture Reduction Evidence from 24 meta-analyses ( 830 ) and 35 additional r and omized trials published after the meta-analyses ( 3165 ) described the effect of 9 of the 14 agents ( alendronate , etidronate , risedronate , calcitonin , estrogen , teriparatide , raloxifene , calcium , and vitamin D ) on fracture incidence . For 4 agents ( ib and ronate , pamidronate , zoledronic acid , and tamoxifen ) , the review ers found no meta-analyses and instead gathered the evidence from 14 r and omized trials ( 6679 ) . No studies were found that reported fracture rates for testosterone . Three r and omized trials ( 35 , 80 , 81 ) and 1 meta- analysis ( 82 ) evaluated the combination of calcium plus vitamin D on fractures . Bisphosphonates Good- quality evidence showed that alendronate , etidronate , ib and ronate , and risedronate prevent vertebral fractures . In addition , evidence from good- quality studies demonstrated that both alendronate and risedronate prevent nonvertebral and hip fractures . Two large r and omized trials showed that zoledronic acid prevents vertebral and nonvertebral fractures in high-risk population s and reduces the risk for hip fracture ( 67 , 74 ) . Ib and ronate has not been shown to reduce nonvertebral fractures ( 68 ) . Of the 6 fairly small trials that looked at vertebral fractures , 1 demonstrated a statistically significant reduction in fractures with pamidronate relative to placebo ( 0.14 [ 95 % CI , 0.03 to 0.72 ] ) ( 73 ) . However , after these data were pooled , the pooled risk estimate for fractures for pamidronate relative to placebo was not significant ( 0.52 [ CI , 0.21 to 1.24 ] ) ( 6 ) . Calcitonin Fair- quality evidence shows that calcitonin reduces vertebral fractures ( 83 , 84 ) . Good- quality evidence indicates that calcitonin does not reduce nonvertebral fractures ( 13 , 16 ) . Estrogen Good- quality evidence shows that estrogen reduces the incidence of vertebral ( 29 , 85 ) , nonvertebral ( 86 ) , and hip fractures ( 85 ) . Teriparatide Good- quality evidence shows that teriparatide prevents vertebral fractures . The evidence related to teriparatide preventing nonvertebral fractures is mixed ; 1 large r and omized trial showed a reduction in nonvertebral fractures ( 34 ) but 2 small trials did not ( 87 , 88 ) . SERMs Good- quality evidence shows that raloxifene prevents vertebral fractures , but
Output:
| We found evidence that this group of affected trial reports distorted the evidence base .
Correction of these distortions is slow , uncoordinated and inconsistent . |
MS212118 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Background and Purpose — Among patients with acute stroke , high blood pressure is often associated with poor outcome , although the reason is unclear . We analyzed data from the International Stroke Trial ( IST ) to explore the relationship between systolic blood pressure ( SBP ) , subsequent clinical events over the next 2 weeks , and functional outcome at 6 months in patients with acute stroke . Methods — We included in the analysis 17 398 patients from IST with confirmed ischemic stroke . A single measurement of SBP was made immediately before r and omization . Clinical events within 14 days of r and omization were recorded : recurrent ischemic stroke , symptomatic intracranial hemorrhage , death result ing from presumed cerebral edema , fatal coronary heart disease , and death . Survival and dependency were assessed at 6 months . Outcomes were adjusted for age , sex , clinical stroke syndrome , time to r and omization , consciousness level , atrial fibrillation , and treatment allocation ( aspirin , unfractionated heparin , both , or neither ) . Results — A U-shaped relationship was found between baseline SBP and both early death and late death or dependency : early death increased by 17.9 % for every 10 mm Hg below 150 mm Hg ( P < 0.0001 ) and by 3.8 % for every 10 mm Hg above 150 mm Hg ( P = 0.016 ) . The rate of recurrent ischemic stroke within 14 days increased by 4.2 % for every 10–mm Hg increase in SBP ( P = 0.023 ) ; this association was present in both fatal and nonfatal recurrence . Death result ing from presumed cerebral edema was independently associated with high SBP ( P = 0.004 ) . No relationship between symptomatic intracranial hemorrhage and SBP was seen . Low SBP was associated with a severe clinical stroke ( total anterior circulation syndrome ) and an excess of deaths from coronary heart disease ( P = 0.002 ) . Conclusions — Both high blood pressure and low blood pressure were independent prognostic factors for poor outcome , relationships that appear to be mediated in part by increased rates of early recurrence and death result ing from presumed cerebral edema in patients with high blood pressure and increased coronary heart disease events in those with low blood pressure . The occurrence of symptomatic intracranial hemorrhage within 14 days was independent of SBP Background and Purpose — The practicalities of doing ambulance-based trials where paramedics perform all aspects of a clinical trial involving patients with ultra-acute stroke have not been assessed . Methods — We performed a r and omized controlled trial with screening , consent , r and omization , and treatment performed by paramedics prior to hospitalization . Patients with probable ultra-acute stroke ( < 4 hours ) and systolic blood pressure ( SBP ) > 140 mm Hg were r and omized to transdermal glyceryl trinitrate ( GTN ; 5 mg/24 hours ) or none ( blinding under gauze dressing ) for 7 days with the first dose given by paramedics . The primary outcome was SBP at 2 hours . Results — Of a planned 80 patients , 41 ( 25 GTN , 16 no GTN ) were enrolled > 22 months with median age [ interquartile range ] 79 [ 16 ] years ; men 22 ( 54 % ) ; SBP 168 [ 46 ] ; final diagnosis : stroke 33 ( 80 % ) and transient ischemic attack 3 ( 7 % ) . Time to r and omization was 55 [ 75 ] minutes . After treatment with GTN versus no GTN , SBP at 2 hours was 153 [ 31 ] versus 174 [ 27 ] mm Hg , respectively , with difference −18 [ 30 ] mm Hg ( P=0.030 ) . GTN improved functional outcome with a shift in the modified Rankin Scale by 1 [ 3 ] point ( P=0.040 ) . The rates of death , 4 ( 16 % ) versus 6 ( 38 % ; P=0.15 ) , and serious adverse events , 14 ( 56 % ) versus 10 ( 63 % ; P=0.75 ) , did not differ between GTN and no GTN . Conclusions — Paramedics can successfully enroll patients with ultra-acute stroke into an ambulance-based trial . GTN reduces SBP at 2 hours and seems to be safe in ultra-acute stroke . A larger trial is needed to assess whether GTN improves functional outcome . Clinical Trial Registration — URL : http://www.controlled-trials.com/IS RCT N66434824/66434824 . Unique identifier : 66434824 Summary Background High blood pressure is associated with poor outcome after stroke . Whether blood pressure should be lowered early after stroke , and whether to continue or temporarily withdraw existing antihypertensive drugs , is not known . We assessed outcomes after stroke in patients given drugs to lower their blood pressure . Methods In our multicentre , partial-factorial trial , we r and omly assigned patients admitted to hospital with an acute ischaemic or haemorrhagic stroke and raised systolic blood pressure ( systolic 140–220 mm Hg ) to 7 days of transdermal glyceryl trinitrate ( 5 mg per day ) , started within 48 h of stroke onset , or to no glyceryl trinitrate ( control group ) . A subset of patients who were taking antihypertensive drugs before their stroke were also r and omly assigned to continue or stop taking these drugs . The primary outcome was function , assessed with the modified Rankin Scale at 90 days by observers masked to treatment assignment . This study is registered , number IS RCT N99414122 . Findings Between July 20 , 2001 , and Oct 14 , 2013 , we enrolled 4011 patients . Mean blood pressure was 167 ( SD 19 ) mm Hg/90 ( 13 ) mm Hg at baseline ( median 26 h [ 16–37 ] after stroke onset ) , and was significantly reduced on day 1 in 2000 patients allocated to glyceryl trinitrate compared with 2011 controls ( difference −7·0 [ 95 % CI −8·5 to −5·6 ] mm Hg/–3·5 [ –4·4 to −2·6 ] mm Hg ; both p<0·0001 ) , and on day 7 in 1053 patients allocated to continue antihypertensive drugs compared with 1044 patients r and omised to stop them ( difference −9·5 [ 95 % CI −11·8 to −7·2 ] mm Hg/–5·0 [ –6·4 to −3·7 ] mm Hg ; both p<0·0001 ) . Functional outcome at day 90 did not differ in either treatment comparison — the adjusted common odds ratio ( OR ) for worse outcome with glyceryl trinitrate versus no glyceryl trinitrate was 1·01 ( 95 % CI 0·91–1·13 ; p=0·83 ) , and with continue versus stop antihypertensive drugs OR was 1·05 ( 0·90–1·22 ; p=0·55 ) . Interpretation In patients with acute stroke and high blood pressure , transdermal glyceryl trinitrate lowered blood pressure and had acceptable safety but did not improve functional outcome . We show no evidence to support continuing prestroke antihypertensive drugs in patients in the first few days after acute stroke . Funding UK Medical Research Council BACKGROUND Whether rapid lowering of elevated blood pressure would improve the outcome in patients with intracerebral hemorrhage is not known . METHODS We r and omly assigned 2839 patients who had had a spontaneous intracerebral hemorrhage within the previous 6 hours and who had elevated systolic blood pressure to receive intensive treatment to lower their blood pressure ( with a target systolic level of < 140 mm Hg within 1 hour ) or guideline -recommended treatment ( with a target systolic level of < 180 mm Hg ) with the use of agents of the physician 's choosing . The primary outcome was death or major disability , which was defined as a score of 3 to 6 on the modified Rankin scale ( in which a score of 0 indicates no symptoms , a score of 5 indicates severe disability , and a score of 6 indicates death ) at 90 days . A prespecified ordinal analysis of the modified Rankin score was also performed . The rate of serious adverse events was compared between the two groups . RESULTS Among the 2794 participants for whom the primary outcome could be determined , 719 of 1382 participants ( 52.0 % ) receiving intensive treatment , as compared with 785 of 1412 ( 55.6 % ) receiving guideline -recommended treatment , had a primary outcome event ( odds ratio with intensive treatment , 0.87 ; 95 % confidence interval [ CI ] , 0.75 to 1.01 ; P=0.06 ) . The ordinal analysis showed significantly lower modified Rankin scores with intensive treatment ( odds ratio for greater disability , 0.87 ; 95 % CI , 0.77 to 1.00 ; P=0.04 ) . Mortality was 11.9 % in the group receiving intensive treatment and 12.0 % in the group receiving guideline -recommended treatment . Nonfatal serious adverse events occurred in 23.3 % and 23.6 % of the patients in the two groups , respectively . CONCLUSIONS In patients with intracerebral hemorrhage , intensive lowering of blood pressure did not result in a significant reduction in the rate of the primary outcome of death or severe disability . An ordinal analysis of modified Rankin scores indicated improved functional outcomes with intensive lowering of blood pressure . ( Funded by the National Health and Medical Research Council of Australia ; INTERACT2 Clinical Trials.gov number , NCT00716079 . ) High blood pressure is common during the acute phase of stroke and is associated with a poor outcome . However , the management of high blood pressure remains unclear . The ‘ Efficacy of Nitric Oxide in Stroke ’ trial tested whether transdermal glyceryl trinitrate , a nitric oxide donor that lowers blood pressure , is safe and effective in improving outcome after acute stroke . Efficacy of Nitric Oxide in Stroke is an international multicenter , prospect i ve , r and omized , single-blind , blinded endpoint trial , with funding from the UK Medical Research Council . Patients with acute ischemic stroke or intracerebral hemorrhage and systolic blood pressure 140–220 mmHg were r and omized to glyceryl trinitrate or no glyceryl trinitrate and , where relevant , to continue or stop prestroke antihypertensive therapy . The primary outcome is shift in modified Rankin Scale at three-months . Patients or relatives gave written informed ( proxy ) consent , and all sites had research ethics approval . Analyses will be done by intention to treat . This paper and attachment describe the trial 's statistical analysis plan , developed prior to unblinding of date . The statistical analysis plan contains design and methods for analyses , and unpopulated tables and figures for the two primary publications and some secondary publications . The data base will be locked in late February 2014 in preparation for presentation of the results in May 2014 . The data from the trial will improve the precision of the estimates of the overall treatment effects ( efficacy and safety ) of results from completed trials of blood pressure management in acute stroke , and provide the first large-scale r and omized evidence on transdermal glyceryl trinitrate , and of continuing ( vs. stopping ) prestroke antihypertensive medications , in acute stroke RATIONALE The management of perioperative period for patients with spontaneous intracerebral hemorrhage affects the prognosis . Elevated blood pressure is common in the patients with spontaneous intracerebral hemorrhage and related to a poor outcome . However , study on antihypertensive treatment for surgical patients with spontaneous intracerebral hemorrhage is insufficient . AIMS To determine if the intensive antihypertensive treatment improves the prognosis compared with the conservative antihypertensive treatment followed guidelines in perioperative period for patients with spontaneous intracerebral hemorrhage . DESIGN PATICH is a prospect i ve , parallel , r and omized , assessor-blinded trial . Two hundred eligible patients will be assigned to the intensive group and conservative group r and omly . Patients allocated to the intensive group will receive an intensive antihypertensive treatment aim ing to achieve a target systolic blood pressure of between 120 mmHg and 140 mmHg while the patients in the conservative group will receive conservative antihypertensive treatment as recommended by guidelines for 7 days . Operation will be conducted by well-trained surgeons and the best medical treatment will be given in all patients . Patients will be followed up at 7 days , 30 days , and 90 days . STUDY OUTCOMES Primary outcome of this study is the rate of rehemorrhage in 7 days after surgery . Secondary outcomes include death and dependency at 90 days incidence of ischemic stroke , separate rate of death and dependency at 90 days , health related quality of life ( HRQoL ) at 90 days , incidence of other vascular events , and days of hospitalization . Dependency is defined by a score of 3 - 5 based on the modified Rankin Scale ( mRS ) High blood pressure in acute stroke is common and appears to be associated with a poor outcome . Lowering blood pressure might therefore improve outcome , provided that cerebral perfusion is not compromised . We assessed the effects of glyceryl trinitrate ( GTN ) on cerebral and systemic hemodynamic measures in acute stroke . Ninety patients with acute ischemic or hemorrhagic stroke were r and omized within
Output:
| In people with acute stroke , GTN reduces blood pressure , increases heart rate and headache , but does not alter clinical outcome ( all based on high- quality evidence ) |
MS212119 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
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Input: BACKGROUND Women who have suffered from one episode of postpartum-onset major depression ( PPMD ) experience increased risk for recurrence in the year following another birth . METHODS Non-depressed women ( N=51 ) who had at least one past episode of PPMD were recruited during pregnancy . After birth , subjects were assessed prospect ively each week for 20 weeks with the Hamilton Rating Scale for Depression and Research Diagnostic Criteria for recurrence of major depression . Evaluations were carried out at 24 , 36 , and 52 weeks to assess for episodes beyond 20 weeks postpartum . RESULTS The data revealed a clustering of cases , with five of the 21 recurrences ( 24 % ) occurring in the first 2 weeks . Thirteen of the 21 recurrences ( 67 % ) and 19/21 recurrences ( 90 % ) occurred in the first 20 and 28 weeks following birth , respectively . LIMITATIONS Although it is unusual for studies of this type to be prospect i ve , the sample size is relatively small . CONCLUSIONS The 1-year recurrence rate was 21/51 or 41 % , with a clustering of cases near delivery . All recurrences except two occurred by 28 weeks postpartum 1 Abstract 1.1 Background Suicide is a leading cause of perinatal maternal deaths in industrialised countries but there has been little research to investigate prevalence or correlates of postpartum suicidality . The Edinburgh Postnatal Depression Scale is widely used in primary and maternity services to screen for perinatal depressive disorders , and includes a question on suicidal ideation ( question 10 ) . We aim ed to investigate the prevalence , persistence and correlates of suicidal thoughts in postpartum women in the context of a r and omised controlled trial of treatments for postnatal depression.1.2 Methods Women in primary care were sent postal question naires at 6 weeks postpartum to screen for postnatal depression before recruitment into an RCT . The Edinburgh Postnatal Depression Scale ( EPDS ) was used to screen for postnatal depression and in those with high levels of symptoms , a home visit with a st and ardised psychiatric interview was carried out using the Clinical Interview Schedule-Revised version ( CIS-R ) . Other socio-demographic and clinical variables were measured , including functioning ( SF12 ) and quality of the marital relationship ( GRIMS ) . Women who entered the trial were followed up for 18 weeks.1.3 Results 9 % of 4,150 women who completed the EPDS question relating to suicidal ideation reported some suicidal ideation ( including hardly ever ) ; 4 % reported that the thought of harming themselves had occurred to them sometimes or quite often . In women who entered the r and omised trial and completed the EPDS question relating to suicidal ideation ( n = 253 ) , suicidal ideation was associated with younger age , higher parity and higher levels of depressive symptoms in the multivariate analysis . Endorsement of ' yes , quite often ' to question 10 on the EPDS was associated with affirming at least two CIS-R items on suicidality . We found no association between suicidal ideation and SF-12 physical or mental health or the EPDS total score at 18 weeks.1.4 Conclusions Healthcare professionals using the EPDS should be aware of the significant suicidality that is likely to be present in women endorsing ' yes , quite often ' to question 10 of the EPDS . However , suicidal ideation does not appear to predict poor outcomes in women being treated for postnatal depression . Trial registration Current Controlled Trials IS RCT N16479417 BACKGROUND : Postnatal depression is a common disorder , which can have profound short and long term effects on maternal morbidity , the new infant and the family as a whole . Social factors appear to be particularly important in the aetiology and prognosis of postnatal depression and treatment is often largely social support and psychological interventions . It is not known whether antidepressants are an effective and safe choice for treatment of this disorder . OBJECTIVES : To evaluate the effectiveness of different antidepressant drugs and compare their effectiveness with other forms of treatment . To assess any adverse effects of antidepressants in the mother or the nursing baby . SEARCH STRATEGY : The registers of clinical trials maintained and up date d by the Cochrane Depression , Anxiety and Neurosis Group and the Cochrane Pregnancy and Childbirth Group were search ed . Other data bases ( outlined below ) were also search ed and contacts were made with pharmaceutical companies and experts in the field . SELECTION CRITERIA : All trials were considered in which women with depression in the first six months postpartum were r and omised to receive antidepressants alone or in combination with another treatment , or to receive any other treatment including placebo . DATA COLLECTION AND ANALYSIS : Data was extracted independently from the trial reports by the review ers . Missing information was requested from investigators wherever possible . Data was sought to allow an " intention to treat " analysis . MAIN RESULTS : Only one trial could be included in this review , leaving most of the objectives of the review unfulfilled . Appleby et al ( 1997 ) reported that Fluoxetine was significantly more effective than placebo and , after an initial session of counselling , as effective as a full course of cognitive-behavioural counselling in the treatment of postnatal depression . There was no interaction between medication and counselling . REVIEW ER 'S CONCLUSIONS : Women with postnatal depression can be effectively treated with fluoxetine , which is as effective as a course of cognitive-behavioural counselling in the short-term . However , more trials with a longer follow-up period are needed to compare different antidepressants in the treatment of postnatal depression , and to compare antidepressant treatment with psychosocial interventions . This is an area that has been neglected despite the large public health impact described above OBJECTIVE The efficacy of antidepressants in the treatment of mild-to-moderate postpartum depression and the possible advantage of the combination of an antidepressant and psychotherapy have not been adequately studied . We hypothesized that psychotherapy and concurrent antidepressant treatment would be more effective than psychotherapy alone in the treatment of postpartum depression . METHOD Women diagnosed with mild-to-moderate severity postpartum depression according to DSM-IV-TR criteria were enrolled in an 8-week , r and omized , double-blind , placebo-controlled study . Participants received 12 sessions of focused brief dynamic psychotherapy ( BDP ) concurrently with 8-week sertraline or placebo treatment , followed by a 4-week open phase . Primary outcomes were depression scores measured by the Montgomery-Asberg Depression Rating Scale ( MADRS ) and remission rates . The study was conducted in a referral center from May 2008 to September 2010 . RESULTS Forty of 42 women r and omized into the study entered the intent-to-treat analysis . A significant time effect for the MADRS was observed ( F4,35 = 21.3 , P < .0001 ) ; however , no time-by-group effect was found for any outcome measure . Response rates were 70 % and 55 % for the drug and placebo groups , respectively , and remission rates were 65 % and 50 % , respectively , with no significant difference between groups . CONCLUSION While both treatment groups improved significantly , the results of the present study did not demonstrate a significant benefit for sertraline over placebo as an add-on treatment to focused BDP in mild-to-moderate postpartum depression . Because of the study 's small sample , the results can not be viewed as definitive , and a much larger study is needed to confirm these results . Furthermore , the promising potential of focused BDP as an intervention in this population should be studied under controlled conditions . TRIAL REGISTRATION clinical trials.gov Identifier : NCT01028482 Difficulties in mother – child interaction are commonly observed in the context of postnatal depression . These difficulties may result in part from the negative cognitive bias present in depression , which may in turn lead to biased negative perceptions of the infant : in particular , these biases encompass the negative appraisal of facial expressions . Given the important role of early mother – child interactions in child development it is vital to investigate potential interventions that might be beneficial in ameliorating the negative cognitive bias . This study aim ed to examine the effects of two different antidepressants ( reboxetine and citalopram ) on the appraisal of infant facial expressions of emotion using a faces rating task , and on attention to infant emotion using an attentional probe . Thirty-nine volunteers were r and omly assigned to a double-blind 7-day intervention with either placebo , citalopram or reboxetine . There were significant positive effects on the appraisal of facial expressions ; participants assigned to the placebo group rated positive faces less positively than those either in the citalopram or in the reboxetine groups . However , there was no evidence that these drugs had an effect on attentional vigilance . If antidepressants are able to help a mother to perceive her infant ’s facial expressions as more positive , this may lead to more positive interactions , thereby potentially mitigating the negative effects of depression on infant development . These findings should be treated with caution until replicated in larger and clinical sample Background In the UK , 8–15 % of women suffer from postnatal depression with long term consequences for maternal mood and child development . Current guidelines state that health visitors and GPs should continue to have a major role in the detection and management of postnatal depression . Previous literature suggests that women are reluctant to disclose symptoms of postnatal depression . This study aim ed to explore general practitioners ' ( GPs ) , health visitors ' and women 's views on the disclosure of symptoms which may indicate postnatal depression in primary care . Methods In-depth interviews with GPs , health visitors and women who were participating in a r and omised controlled trial of anti-depressants versus health visitor delivered non-directive counselling for the treatment of postnatal depression . Interviews were audio-taped and fully transcribed . Thematic analysis with an iterative approach was used , allowing the views of practitioners and patients to be explored and then compared . Results Nineteen GPs , 14 health visitors and 28 women were interviewed . A number of common themes were identified across all three data sets : underst and ing and negotiating the diagnosis of postnatal depression , hindering and facilitating disclosure , and the system of care . Both women and health professionals described postnatal depression in psychosocial terms : an adjustment reaction to change in life circumstances and the reality of motherhood not meeting personal expectations . Women described making a conscious decision about whether or not to disclose their feelings to their GP or health visitor . Health professionals described strategies used to hinder disclosure and described a reluctance to make a diagnosis of postnatal depression , as they had few personal re sources to manage women with postnatal depression themselves , and no services to which to refer women for further treatment . Conclusion To improve disclosure of symptoms in primary care , there should be a move away from question ing why health professionals do not make the diagnosis of depression and in response suggesting that education and training will improve skills and thus improve detection of depression . Improving the detection and management of postnatal depression in primary care requires recognition of the context in which women consult , and system changes that ensure health professionals work in an environment that can facilitate disclosure and that the necessary re sources for management are available . Trail Registration IS RCT N BACKGROUND The optimum way to improve the recognition and treatment of postnatal depression in developing countries is uncertain . We compared the effectiveness of a multicomponent intervention with usual care to treat postnatal depression in low-income mothers in primary -care clinics in Santiago , Chile . METHODS 230 mothers with major depression attending postnatal clinics were r and omly allocated to either a multicomponent intervention ( n=114 ) or usual care ( n=116 ) . The multicomponent intervention involved a psychoeducational group , treatment adherence support , and pharmacotherapy if needed . Usual care included all services normally available in the clinics , including antidepressant drugs , brief psychotherapeutic interventions , medical consultations , or external referral for specialty treatment . The primary outcome measure was the Edinburgh postnatal depression scale ( EPDS ) score at 3 and 6 months after r and omisation . Analysis was by intention to treat . This study is registered with Clinical Trials.gov , number NCT00518830 . FINDINGS 208 ( 90 % ) of women r and omly assigned to treatment groups completed assessment s. The crude mean EPDS score was lower for the multicomponent intervention group than for the usual care group at 3 months ( 8.5 [ 95 % CI 7.2 - 9.7 ] vs 12.8 [ 11.3 - 14.1 ] ) . Although these differences between groups decreased by 6 months , EPDS score remained better in multicomponent intervention group than in usual care group ( 10.9 [ 9.6 - 12.2 ] vs 12.5 [ 11.1 - 13.8 ] ) . The adjusted difference in mean EPDS between the two groups at 3 months was -4.5 ( 95 % CI -6.3 to -2.7 ; p<0.0001 ) . The decrease in the number of women taking antidepressants after 3 months was greater in the intervention group than in the usual care group ( multicomponent intervention from 60/101 [ 59 % ; 95 % CI 49 - 69 % ] to 38/106 [ 36 % ; 27 - 46 % ] ; usual care from 18/108 [ 17 % ; 10 - 25 % ] to 11/102 [ 11 % ; 6 - 19 % ] ) . INTERPRETATION Our findings suggest that low-income mothers with depression and who have newly born children could be effectively helped , even in low-income setting s , through multicom
Output:
| In addition , one study comparing sertraline with nortriptyline ( a tricyclic antidepressant ) found no difference in effectiveness ( 109 participants ) .Side effects were experienced by a substantial proportion of women , but there was no evidence of a meaningful difference in the number of adverse effects between treatment arms in any study .
Pooled estimates for response and remission found that SSRIs were significantly more effective than placebo for women with postnatal depression .
There is also inadequate evidence on whether the benefits of antidepressants persist beyond eight weeks or whether they have short- or long-term adverse effects on breastfeeding infants . |
MS212120 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
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Input: PURPOSE We assessed the prognostic importance of the level of thymidylate synthase ( TS ) expression in patients with primary rectal cancer and whether , for Dukes ' B and C cancer patients , the benefit of chemotherapy was associated with TS expression . PATIENTS AND METHODS The level of TS expression in the primary rectal cancers of 294 of 801 patients enrolled on protocol R-01 of the National Surgical Adjuvant Breast and Bowel Project ( NSABP ) was immunohistochemically assessed with the monoclonal antibody TS 106 . RESULTS Forty-nine percent of patients whose tumors had low TS levels ( n = 91 ) were disease free at 5 years compared with 27 % of patients with high levels of TS ( n = 203 ; P < .01 ) . Moreover , 60 % of patients with low TS levels were alive after 5 years compared with 40 % of patients with high TS levels ( P < .01 ) . The level of TS protein was significantly associated with Dukes ' stage ( P < .01 ) ; patients with a more advanced Dukes ' stage had a significantly higher level of TS . The level of TS expression remained prognostic for both disease-free survival ( P < .01 ) and survival ( P < .05 ) independent of Dukes ' stage and other pathologic characteristics evaluated . Thirty-eight percent and 54 % of patients with high TS levels ( n = 71 ) were disease free and alive , respectively , after 5 years when treated with chemotherapy , compared with 17 % and 31 % , respectively , of similar patients when treated with surgery alone ( n = 64 ) ( P < .01 ) . No difference was noted in disease-free survival ( P = .46 ) or survival ( P = .43 ) in patients with low TS levels . CONCLUSION The expression of TS is an important independent prognosticator of disease-free survival and survival in patients with rectal cancer . Adjuvant fluorouracil (5-FU)-based chemotherapy demonstrated significant improvement in disease-free and overall survival for patients with high TS levels . Prospect i ve studies measuring TS levels will be needed to underst and further the role of TS as a prognosticator of survival and chemotherapeutic benefit We performed a clinical study to identify biological markers useful for the treatment of resectable non-small-cell lung cancers ( NSCLCs ) . In all , 173 patients were studied . By immunohistochemistry , we evaluated the Ki-67 proliferation index , tumour vascularity , thymidylate synthase ( TS ) , vascular endothelial growth factor (VEGF)-A , VEGF-C , and E (epithelial)-cadherin . Concerning the survival of NSCLC patients , tumour vascularity ( P<0.01 ) , VEGF-A status ( P=0.03 ) , VEGF-C status ( P=0.03 ) , and E-cadherin status ( P=0.03 ) were significant prognostic factors in patients with stage I NSCLCs . The Ki-67 proliferation index ( P=0.02 ) and TS status ( P<0.01 ) were significant prognostic factors in patients with stage II – III NSCLCs . In patients with stage II – III NSCLCs , furthermore , the survival of UFT ( a combination of tegafur and uracil)-treated patients with TS-negative tumours was significantly better than those of any other patients . Biological markers associated with tumour angiogenesis or metastasis are useful for the detection of aggressive tumours among early-stage NSCLCs . Postoperative chemotherapy might be necessary in such tumours even in stage I. In contrast , tumour proliferation rate and TS status are useful markers for identifying less aggressive tumours in locally advanced NSCLCs . Thymidylate synthase expression is also a useful marker to evaluate responsiveness of UFT-based chemotherapy for these tumours Purpose : This phase II trial of pemetrexed explored potential correlations between treatment outcome ( antitumor activity ) and molecular target expression . Experimental Design : Chemonaïve patients with advanced breast cancer received up to three cycles of pemetrexed 500 mg/m2 ( 10-minute i.v . infusion ) on day 1 of a 21-day cycle , with folic acid and vitamin B12 supplementation . Tumors were surgically removed after the last cycle of pemetrexed as clinical ly indicated . Biopsies were taken at baseline , 24 hours after infusion in cycle 1 , and after cycle 3 . Results : Sixty-one women ( median age , 46 years ; range , 32 - 72 years ) were treated and were evaluable for response . Objective response rate was 31 % . Simple logistic regression suggested a potential relationship between mRNA expression of thymidylate synthase ( TS ) and pemetrexed response ( P = 0.103 ) . Based on threshold analysis , patients with “ low ” baseline TS ( ≤71 ) were more likely to respond to pemetrexed than patients with “ high ” baseline TS ( > 71 ) . Expression of baseline dihydrofolate reductase and glycinamide ribonucleotide formyl transferase tended to be higher in responders but this association was not significant ( P > 0.311 ) . TS expression increased significantly between baseline and biopsy 2 ( P = 0.004 ) and dropped to near baseline levels at biopsy 3 . Conversely , dihydrofolate reductase and glycinamide ribonucleotide formyl transferase decreased after pemetrexed chemotherapy . Conclusions : Our results suggest a potential association between “ low ” pretreatment TS expression levels and response to pemetrexed chemotherapy . Future trials examining expression levels of other genes important to the folate pathway and /or breast cancer may identify a more robust multigene profile that can better predict response to this novel antifolate The purpose of this study was to define the prognostic value of a group of molecular tumor markers in a well-staged population of patients treated with trimodality therapy for esophageal cancer . The original pretreatment paraffin-embedded endoscopic esophageal tumor biopsy material was obtained from 118 patients treated with concurrent cisplatin + 5-fluorouracil ( 5-FU ) + 45 Gy radiation followed by resection from 1986 until 1997 at the Duke University Comprehensive Cancer Center . Three markers of possible platinum chemotherapy association [ metallothionein ( MT ) , glutathione S-transferase-pi ( GST-pi ) , P-glycoprotein ( P-gp or multidrug resistance ) ] and one marker of possible 5-FU association [ thymidylate synthase ( TS ) ] were measured using immunohistochemistry . The median cancer-free survival was 25.0 months , with a significantly improved survival for the 38 patients who had a complete response ( P < 0.001 ) . High-level expression of GST-pi , P-gp , and TS were associated with a decreased survival . MT was not significant in this population . Multivariate analysis identified high-level expression in two of the platinum markers ( GST-pi and P-gp ) and the 5-FU marker TS as independent predictors of early recurrence and death . In conclusion , this investigation measured three possible markers associated with platinum and one possible marker associated with 5-FU in a cohort of esophageal cancer patients . Independent prognostic significance was observed , which suggests that it may be possible to predict which patients may benefit most from trimodality therapy . These data need to be reproduced in a prospect i ve investigation Introduction : In retrospective analyses of patients with nonsquamous non – small-cell lung cancer treated with pemetrexed , low thymidylate synthase ( TS ) expression is associated with better clinical outcomes . This phase II study explored this association prospect ively at the protein and mRNA-expression level . Methods : Treatment-naive patients with nonsquamous non – small-cell lung cancer ( stage IIIB/IV ) had four cycles of first-line chemotherapy with pemetrexed/cisplatin . Nonprogressing patients continued on pemetrexed maintenance until progression or maximum tolerability . TS expression ( nucleus/cytoplasm/total ) was assessed in diagnostic tissue sample s by immunohistochemistry ( IHC ; H-scores ) , and quantitative reverse-transcriptase polymerase chain reaction . Cox regression was used to assess the association between H-scores and progression-free/overall survival ( PFS/OS ) distribution estimated by the Kaplan – Meier method . Maximal & khgr;2 analysis identified optimal cutpoints between low TS- and high TS-expression groups , yielding maximal associations with PFS/OS . Results : The study enrolled 70 patients ; of these 43 ( 61.4 % ) started maintenance treatment . In 60 patients with valid H-scores , median ( m ) PFS was 5.5 ( 95 % confidence interval [ CI ] , 3.9–6.9 ) months , mOS was 9.6 ( 95 % CI , 7.3–15.7 ) months . Higher nuclear TS expression was significantly associated with shorter PFS and OS ( primary analysis IHC , PFS : p < 0.0001 ; hazard ratio per 1-unit increase : 1.015 ; 95%CI , 1.008–1.021 ) . At the optimal cutpoint of nuclear H-score ( 70 ) , mPFS in the low TS- versus high TS-expression groups was 7.1 ( 5.7–8.3 ) versus 2.6 ( 1.3–4.1 ) months ( p = 0.0015 ; hazard ratio = 0.28 ; 95%CI , 0.16–0.52 ; n = 40/20 ) . Trends were similar for cytoplasm H-scores , quantitative reverse-transcriptase polymerase chain reaction and other clinical endpoints ( OS , response , and disease control ) . Conclusions : The primary endpoint was met ; low TS expression was associated with longer PFS . Further r and omized studies are needed to explore nuclear TS IHC expression as a potential biomarker of clinical outcomes for pemetrexed treatment in larger patient cohorts Introduction : This study is to evaluate whether thymidylate synthase ( TS ) or thyroid transcription factor 1 ( TTF1 ) protein expression can predict clinical outcomes for pemetrexed-based chemotherapy in patients with nonsquamous non-small cell lung cancer ( NSCLC ) . Methods : Two hundred eighty-five consecutive patients with nonsquamous NSCLC treated with pemetrexed-based chemotherapy were immunohistochemically analyzed for the expressions of TS and TTF1 . Results : TS and TTF1 expression were successfully analyzed in 193 and 284 cases , respectively . Tumors with TS-negativity or TTF1-positivity were more frequent in patients who were female , younger , had adenocarcinoma , or had never smoked . Higher response rates for pemetrexed-based chemotherapy were associated with TS-negativity ( 33.7 % versus 14.1 % , p = 0.002 ) and TTF1-positivity ( 28.1 % versus 9.8 % , p < 0.001 ) . In univariate analysis , progression-free survival for pemetrexed-based chemotherapy was significantly longer in groups with adenocarcinoma ( 2.9 versus 1.4 months , p = 0.001 ) , TS-negativity ( 4.1 versus 2.0 months , p = 0.001 ) , and TTF1-positivity ( 3.8 versus 1.3 months , p < 0.001 ) . In multivariate analysis , TS-negativity ( hazard ratio [ HR ] = 0.70 ; 95 % confidence interval [ CI ] , 0.51–0.97 ) and TTF1-positivity ( HR = 0.51 ; 95 % CI , 0.35–0.73 ) were associated with longer progression-free survival . Patients with TTF1-positive tumors also had significantly longer overall survival times than patients with TTF1-negative tumors ( 25.4 versus 14.2 months , HR = 0.55 ; 95 % CI , 0.39–0.77 ) . Conclusions : Low TS or high TTF1 protein expression was significantly associated with better clinical outcomes in nonsquamous NSCLC patients who were treated with pemetrexed-based chemotherapy . The predictive role of TS or TTF1 expression should be further vali date d in a prospect i ve r and omized study BACKGROUND UFT ( tegafur + uracil ) has been reported to be effective as an adjuvant in postoperative chemotherapy for non-small cell lung cancer ( NSCLC ) in a r and omized prospect i ve study . Thymidylate synthase ( TS ) and dihydropyrimidine dehydrogenase ( DPD ) expression were investigated in resected tumors and the relationship between their expression and clinical factors in NSCLC patients was examined . PATIENTS AND METHODS Fifty-four NSCLC patients had undergone complete surgical resection and lymph node dissection , and had been administered UFT post-surgery . The TS and DPD expression in the tumor tissues was evaluated by immunohistochemical staining . The relationship between TS and /or DPD expression and clinicopathological factors was examined . RESULTS There were 38 TS-negative and 16 TS-positive cases , and 22 DPD-negative and 32 DPD-positive cases . There was no significant difference between the patients with TS
Output:
| Low TS protein expression is a favorable predictive factor for better OS/PFS in NSCLC patients treated with TS-targeted drugs . |
MS212121 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: This study describes a new surgical technique for harvesting intra-membranous bone from the m and ibular symphyseal region and using it as an inlay graft . The surgical technique of turning a complex-shaped defect into a defect of defined size by contour preparation and insertion of an appropriate inlay graft was used in 31 patients . At 4 months , 15 patients ( 48 % ) showed negligible graft resorption of 0.33 mm . At 5 - 8 months the resorption rate in the remaining 16 patients was around 1.22 mm . All in all , a significant positive correlation was found between bone resorption and time ( r = 0.574 ; P < 0.001 ) . All patients received an implant after the fixation screw was removed . A conservative interpretation of the results suggests that , on account of the flush fit and the early revascularization of the graft , implants may and should , in fact , be inserted earlier in order to prevent graft resorption OBJECTIVES To evaluate healing of marginal defects in immediate transmucosal implants grafted with anorganic bovine bone , and to assess mucosal and radiographic outcomes 3 - 4 years following restoration . MATERIAL AND METHODS Thirty immediate transmucosal implants in maxillary anterior extraction sites of 30 patients r and omly received BioOss ( N=10 ; BG ) , BioOss and resorbable collagen membrane ( N=10 ; BG+M ) or no graft ( N=10 ; control ) . RESULTS Vertical defect height ( VDH ) reductions of 81.2+/-5 % , 70.5+/-17.4 % and 68.2+/-16.6 % , and horizontal defect depth ( HDD ) reductions of 71.7+/-34.3 % , 81.7+/-33.7 % and 55+/-28.4 % were observed for BG , BG+M and control groups , respectively , with no significant inter-group differences . Horizontal resorption was significantly greater in control group ( 48.3+/-9.5 % ) when compared with BG ( 15.8+/-16.9 % ) and BG+M ( 20+/-21.9 % ) groups ( P=0.000 ) . Ten sites ( 33.3 % ) exhibited recession of the mucosa after 6 months ; eight ( 26.7 % ) had an unsatisfactory esthetic result post-restoration due to recession . Mucosal recession was significantly associated ( P=0.032 ) with buccally positioned implants ( HDD 1.1+/-0.3 mm ) when compared with lingually positioned implants ( HDD 2.3+/-0.6 mm ) . In 19 patients followed for a mean of 4.0+/-0.7 years , marginal mucosa and bone levels remained stable following restoration . CONCLUSION BioOss significantly reduced horizontal resorption of buccal bone . There is a risk of mucosal recession and adverse soft tissue esthetics with immediate implant placement . However , this risk may be reduced by avoiding a buccal position of the implant in the extraction socket Two techniques of ridge augmentation using onlay bone graft alone or associated with a non-resorbable membrane have been previously described . This prospect i ve , r and omized study compared these two techniques at 6 months , in terms of bone gain , resorption and quality obtained at edentulous sites . Osseous measurements were taken using stents , callipers and CT-scans . Membrane exposure occurred at one site , 4 weeks after placement . Endosseous implants were successfully placed at all grafted sites . The mean graft thickness for all subjects was 4.7 mm ( range : 2.3 - 6.2 mm ) . Overall mean resorption was 1.5 mm ( range : 0 - 4.6 mm ) whereas overall mean width gain was 3.2 mm ( range : 0.8 - 6.2 mm ) . Six months following surgery , the membrane group experienced significantly less bone resorption than the graft alone group ( P<0.01 ) . Width augmentation did not differ significantly between the two groups . In conclusion , combining a membrane with an onlay graft demonstrates less bone resorption with a minimal risk of complications . Longer follow-up is needed to confirm the benefits of using a non-resorbable membrane BACKGROUND Early implant placement is one of the treatment options after tooth extraction . Implant surgery is performed after a healing period of 4 to 8 weeks and combined with a simultaneous contour augmentation using the guided bone regeneration technique to rebuild stable esthetic facial hard- and soft-tissue contours . METHODS In this prospect i ve study , 20 patients were treated with an implant-born single crown and followed for 3 years . Clinical , radiologic , and esthetic parameters were recorded to assess treatment outcomes . RESULTS At the 3-year examination , all 20 implants were successfully integrated , demonstrating ankylotic stability and healthy peri-implant soft tissues as documented by st and ard clinical parameters . Esthetic outcomes were assessed by the pink esthetic score ( PES ) and white esthetic score ( WES ) and confirmed pleasing results overall . WES values were slightly superior to PES values . Periapical radiographs showed minimal crestal bone loss around used bone-level implants with a mean bone loss of 0.18 mm at 3 years . Only two implants revealed bone loss between 0.5 and 1.0 mm . One of these implants had minor mucosal recession < 1.0 mm . CONCLUSIONS This prospect i ve study evaluates the concept of early implant placement and demonstrated successful tissue integration for all 20 implants and stable bone-crest levels around implant-abutment interfaces according to the platform-switching concept . The midterm 3-year follow-up revealed pleasing esthetic outcomes and stable facial soft tissues . The risk of mucosal recession was low , with only one patient showing minor recession of the facial mucosa . These encouraging results need to be confirmed with a 5-year follow-up examination Bone grafting may be required prior to implant placement , at the time of implant placement , or subsequent to it . The aim of this study was to compare the healing of onlay block grafts when deproteinized bovine bone coverage was used with the healing of the grafts without such coverage . The purpose was a clinical evaluation of deproteinized bovine bone 's ability to reduce grafted bone resorption . The results indicated that bovine bone can be placed over grafted areas , taking advantage of its osteoconductive properties and compensating for the natural bone resorption caused by remodeling OBJECTIVES Autologous bone augmentation to rebuild compromised alveolar ridge contour prior to implant placement allows for favorable three-dimensional implant positioning to achieve optimum implant esthetics . The aim of the present study was to evaluate peri-implant soft tissue conditions around single-tooth implants following bone grafts in the esthetic zone of the maxilla . MATERIAL S AND METHODS Sixty patients underwent autologous bone augmentation of deficient maxillary sites prior to placement of 85 implants in the esthetic zone . In case of multiple implants per patient , one implant was r and omly selected . Objective evaluation of 60 single-tooth implants was performed using the Pink-Esthetic-Score ( PES ) and Papilla Index ( PI ) and supplemented by subjective patient evaluation , as well as clinical and radiologic examination . RESULTS Objective ratings of implant esthetics were satisfactory ( median PES : 11 , median PI : 2 ) and significantly correlated with high patient satisfaction ( mean VAS score : 80 % ) . Both esthetic indices demonstrated respectable levels of inter- as well as intra-observer agreement . Poor implant esthetics ( low PES and PI ratings ) were significantly associated with increased anatomic crown height , while no influence of horizontal implant-tooth distance could be found . CONCLUSIONS The present investigation indicates that favorable esthetic results may be achieved in the augmented anterior maxilla . However , bony reconstruction of compromised alveolar ridges does not guarantee optimum implant esthetics The purpose of this study was to evaluate the feasibility of using a bioactive alloplast and a physical barrier to augment localized alveolar ridge defects for the subsequent placement of dental implants . Twelve systemically healthy patients ( aged 29 to 55 years ) with inadequate dental alveolar ridge widths were selected for study . All patients completed initial therapy , which included scaling , root planing , and oral hygiene instruction . All ridge defects were augmented with a bioactive glass alloplast and a titanium-reinforced e-PTFE barrier . Vertical ( height ) and horizontal ( width ) hard tissue measurements were taken the day of ridge augmentation surgery ( baseline ) and at the 6-month reentry surgery . The change in ridge width varied from a loss of 1 mm to a gain of 4.5 mm , with a mean gain of 1.1 mm ( P < .03 ) . Eight of the 12 sites gained 1 mm or less . The difference in mean ridge width gain between maxillary and m and ibular sites was not statistically significant ( P > .08 ) . Mean ridge width gain was 1.1 mm for both maxillary and m and ibular sites . There was a loss in bone height of 0.3 mm from baseline . Four implants in four patients could not be placed because of inadequate ridge width augmentation . Histologic examination of the grafted sites revealed connective tissue encapsulation of most residual graft particles . In this study , bioactive glass particulate and an e-PTFE barrier did not consistently augment localized ridge defects for dental implant placement The aim of this study was to evaluate the efficacy of allogeneic block grafts impregnated with autologous bone marrow in horizontal ridge augmentation therapy . Ten patients with severe ridge volume deficiency in the anterior maxilla were treated with horizontal ridge augmentation . The patients were r and omized into two groups : Five patients , using two allogeneic block grafts , were in the control group , and five patients , using two allogeneic block grafts impregnated with autologous bone marrow , were in the test group . Hematologists collected 4 mL of bone marrow from the iliac crest of the patients in the test group immediately prior to the surgeries . The blocks were fixed using titanium screws to obtain rigid fixation and to st and ardize the reference points for measurement purpose s. CT scans were obtained both preoperatively and six months postoperatively to allow evaluation of horizontal bone gain . After a healing period of six months , the sites were reopened and the screws were removed . Before implant placement , bone cores were harvested and prepared for histologic and histomorphometric evaluation . Tomographic and histomorphometric measurements were recorded . The test group demonstrated better tomographic results ( P < 0.05 ) in augmenting alveolar thickness , with a mean value of 4.60 ± 1.43 mm ( 118.23 ± 56.93 % ) , while the control group had bone gain of 2.15 ± 0.47 mm ( 49.91 ± 20.24 % ) . Despite the different results in alveolar thickness gained between groups , all sites received dental implants . The histomorphometric analysis also showed better results ( P < 0.05 ) in the amount of vital mineralized bone in the test group as compared to the control group . The findings of this study suggest that an autologous bone marrow aspirate can increase the regenerative potential of corticocancellous allogeneic bone grafts A classification of the edentulous jaws has been developed based on a r and omised cross-sectional study from a sample of 300 dried skulls . It was noted that whilst the shape of the basalar process of the m and ible and maxilla remains relatively stable , changes in shape of the alveolar process is highly significant in both the vertical and horizontal axes . In general , the changes of shape of the alveolar process follows a predictable pattern . Such a classification serves to simplify description of the residual ridge and thereby assist communication between clinicians ; aid selection of the appropriate surgical prosthodontic technique ; offer an objective baseline from which to evaluate and compare different treatment methods ; and help in deciding on interceptive techniques to preserve the alveolar process . An awareness of the pattern of resorption that takes place in various parts of the edentulous jaws , enables clinicians to anticipate and avert future problems BACKGROUND Various causes of facial bone loss around dental implants are reported in the literature ; however , reports on the influence of residual facial bone thickness on the facial bone response ( loss or gain ) have not been published . This study measured changes in vertical dimension of facial bone between implant insertion and uncovering and compared these changes to facial bone thickness for more than 3,000 hydroxyapatite (HA)-coated and non-HA-coated root-form dental implants . METHODS Subjects were predominantly white males , 18 to 80 + years of age ( mean 62.9 years ) , who were patients at 30 Department of Veterans Affairs Medical Centers and two university dental clinics . Alveolar ridges ranged from normal to resorbed with intact basal bone . Following preparation of the osteotomy site , direct measurements with calipers were made of the residual facial bone thickness , approximately 0.5 mm below the crest of the bone . The distance from the top of the implants to the crest of the facial bone was also measured using periodontal probes . Implants were uncovered between 3 to 4 months in the m and ible and 6 to 8 months in the maxilla after insertion . Facial bone
Output:
| Staged and simultaneous augmentation procedures in the anterior maxilla are both associated with high implant success and survival rates .
The level of evidence , however , is better for the staged approach than for the simultaneous one |
MS212122 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: A case-control study was conducted within Group Health Cooperative of Puget Sound to evaluate the relation between prior vasectomy and the risk of prostate cancer . Cases consisted of 175 men newly diagnosed with histologically confirmed prostate cancer during 1989 - 1991 . A total of 258 controls , matched to cases on birth year and membership status , were r and omly selected from the general membership of the plan . Information was collected from mailed question naires and medical records on medical history , including prior vasectomy , anthropometric measures , family history of prostate cancer , personal habits , and medical care utilization , and demographic factors . Conditional logistic regression analyses showed that the odds ratio for prostate cancer associated with vasectomy was 0.86 ( 95 % confidence interval 0.57 - 1.32 ) after adjustment for confounders . The odds ratio estimate did not differ substantially by age at vasectomy or time since vasectomy . However , the odds ratio estimate for prostate cancer associated with vasectomy tended to be increased among men who had a father or brother with prostate cancer . Nevertheless , the increased risk may be related to detection bias or differential participation rates due to both vasectomy status and a family history of prostate cancer . These results suggest no overall association between vasectomy and prostate cancer OBJECTIVES CP/CPPS is a commonly observed distress in male patients . Because of its little-known etiology , no effective therapy has been developed which has promising outcomes . Therefore , there is a need to develop a valid model which can mimic the etiology of CP/CPPS . MATERIAL S AND METHODS Fifty male C57BL/6 mice were r and omly and averagely divided into 5 groups of 10 mice each . The control group was injected with 0.9 % NaCl solution . Aluminum hydroxide and T2 groups were injected with aluminum hydroxide adjuvant and T2 peptide . T2 plus complete Freund adjuvant ( CFA ) with aluminum hydroxide group was injected with a mixture of T2 , CFA and aluminum hydroxide adjuvant . At the same time , CFA group was injected with complete Freund adjuvant . Hematoxylin-eosin stain and immunohistochemistry were used to investigate inflammatory lesion and expression of IL-β1 . Furthermore , TNF-α and CRP protein levels were evaluated by using commercially available ELISA kits . The ANOVA test was used to compare the statistical differences among groups . RESULTS Prostates from a mixture of T2 plus CFA with aluminum hydroxide immunized mice showed elevated lesions and high level of inflammatory cells infiltration compared to the other groups . In addition , the levels of TNF-α , IL-β1 , and CRP were also higher in the T2 plus CFA with aluminum hydroxide group as compared to the other groups . CONCLUSION Our results showed that T2 with CFA plus aluminum hydroxide adjuvant injection could successfully induce CP/CPPS in mice . This autoimmune novel model provides a useful , economic , safer , and easy tool for exploring the etiology and pathophysiology of CP/CPPS which will improve the therapeutic outcomes PURPOSE Black men are diagnosed with prostate cancer more often than white men , present with more advanced disease and have worse stage specific survival . Given the high risk of incidence and mortality in this population , determining potentially modifiable factors is important . Recent studies have suggested a link between chronic inflammation and development of prostate cancer . In concurrence , population based studies of white men have revealed an increased risk of prostate cancer with history of sexually transmitted diseases and prostatitis . MATERIAL S AND METHODS We explored the chronic inflammation hypothesis of prostate cancer development among black men by examining sexual activity , sexually transmitted diseases and prostatitis in a population based study of 129 patients and 703 controls 40 to 79 years old . RESULTS After adjusting for age , income , cigarette smoking , and history of digital rectal examination and prostate specific antigen tests in the last 5 years , we observed that a history of gonorrhea infection and prostatitis increased the odds of prostate cancer 1.78-fold ( 95 % CI 1.13 , 2.79 ) and 4.93-fold ( 95 % CI 2.79 , 8.74 ) , respectively . Men reporting 25 or more sexual partners were 2.80 ( 95 % CI 1.29 , 6.09 ) times more likely to be diagnosed with cancer compared to men with 5 or fewer partners . CONCLUSIONS Our findings support the significance of prior sexual practice s , exposure to sexually transmitted microbial agents and history of prostatic infection in the natural history of prostate cancer in black men . Additional prospect i ve research incorporating serological markers of infectious agents or predictive markers of chronic inflammation should serve to eluci date the possible causal pathway of recurring or persistent infection in the etiology of prostate cancer in black men Background Prostatitis and sexually transmitted diseases ( STDs ) have been positively associated with prostate cancer in previous case-control studies . However , results from recent prospect i ve studies have been inconclusive . Method ogy/Principal Findings We investigated the association between prostatitis , STDs , and prostate cancer among African American , Asian American , Latino , and White participants of the California Men 's Health Study . Our analysis included 68,675 men , who completed a detailed baseline question naire in 2002–2003 . We identified 1,658 incident prostate cancer cases during the follow-up period to June 30 , 2006 . Cox proportional hazards models were used to estimate relative risks and 95 % confidence intervals . Overall , men having a history of prostatitis had an increased risk of prostate cancer than men with no history ( RR = 1.30 ; 95 % CI : 1.10–1.54 ) . Longer duration of prostatitis symptoms was also associated with an increased risk of prostate cancer ( P trend = 0.003 ) . In addition , among men screened for prostate cancer ( 1 or 2 PSA tests ) , a non-significant positive association was observed between prostatitis and prostate cancer ( RR = 1.10 ; 95 % CI : 0.75–1.63 ) . STDs were not associated with overall prostate cancer risk . In racial/ethnic stratified analysis , Latinos reporting any STDs had an increased risk of disease than those with no STDs ( RR = 1.43 ; 95 % CI : 1.07–1.91 ) . Interestingly , foreign-born Latinos displayed a larger risk associated with STDs ( RR = 1.87 ; 95 % CI : 1.16–3.02 ) than U.S. born Latinos ( RR = 1.15 ; 95 % CI : 0.76–3.02 ) . Conclusion In summary , results from this prospect i ve study suggest that prostatitis and STDs may be involved in prostate cancer susceptibility . While we can not rule out the possible influence of incidental detection , future studies are warranted to further investigate the role of infectious agents related to prostatitis and STDs in prostate cancer development Background : The incidence of prostate cancer is much lower in Asian men than in Western men . This study investigated whether prostate cancer is associated with prostatitis , benign prostatic hyperplasia ( BPH ) , and other medical conditions in the low-incidence population . Methods : From the cl aims data obtained from the universal National Health Insurance of Taiwan , we identified 1184 patients with prostate cancer diagnosed from 1997 to 2008 . Controls comprised 4736 men r and omly selected from a cancer-free population . Both groups were 50 years of age or above . Medical histories between the two groups were compared . Results : Multivariate logistic regression analysis showed that prostatitis and BPH had stronger association with prostate cancer than the other medical conditions tested . Compared with men without prostatitis and BPH , a higher odds ratio ( OR ) for prostate cancer was associated with BPH ( 26.2 , 95 % confidence interval ( CI ) 20.8–33.0 ) than with prostatitis ( 10.5 , 95 % CI=3.36–32.7 ) . Men with both conditions had an OR of 49.2 ( 95 % CI=34.7–69.9 ) . Conclusion : Men with prostate cancer have strong association with prostatitis and /or BPH . Prostatitis interacts with BPH , result ing in higher estimated relative risk of prostate cancer in men suffering from both conditions AIMS Interstitial cystitis/bladder pain syndrome ( IC/BPS ) is a prevalent disorder that may contribute to bladder cancer ( BC ) . This cohort study set out to investigate the association between IC/BPS and BC by using a population -based data set . METHODS The data for this study were source d from the Taiwan National Health Insurance program . The case cohort comprised 7,562 patients with IC/BPS , and 22,686 r and omly selected subjects were used as a comparison cohort . A Cox proportional hazards regression model ( stratified by age group , geographic location , urbanization level , and the index year ) was constructed to estimate the risk of subsequent BC following a diagnosis of IC/BPS . We also ran the analysis utilizing an alternative comparison cohort composed of patients with urinary incontinence ( UI ) . RESULTS In the study sample of 30,248 patients , 96 patients ( 0.32 % ) received a diagnosis of BC during the 3-year follow-up period ; 48 ( 0.63 % of patients with IC/BPS ) were from the study cohort ; and 48 ( 0.21 % of patients without IC/BPS ) were from the comparison cohort . The incidence rate of BC was 2.12 ( 95 % CI : 1.58 - 2.78 ) per 1,000 person-years in patients with IC/BPS and 0.70 ( 95 % CI : 0.52 - 0.92 ) per 1,000 person-years in comparison patients . Cox proportional analysis revealed that the adjusted HR for BC during the 3-year follow-up period for patients with IC/BPS was 2.95 ( 95 % CI : 1.97 - 4.41 ) that of comparison subjects . When performing the analysis with the alternative UI comparison cohort , the adjusted HR for BC was 1.96 ( 95 % CI : 1.14 - 3.39 ) . CONCLUSIONS This investigation detected a novel association between BC and prior IC/BPS A population -based case-control study of prostate cancer was performed in King County , Washington , in White men and Black men aged 40 - 64 years , between 1993 and 1996 . Incident prostate cancer cases ( n = 753 ) were identified from the Seattle-Puget Sound Surveillance , Epidemiology , and End Results ( SEER ) cancer registry . Controls ( n = 703 ) were identified through r and om digit dialing and were frequency matched to cases on age . Sexual behavior , medical history , and other potential prostate cancer risk factors were ascertained through an in-person interview . There was no relation between sexual orientation and prostate cancer , although the number of men who had sex with men was small . Risk estimates increased directly with the lifetime number of female sexual partners ( trend p < 0.001 ) but not with male partners ( trend p = 0.62 ) . Risk also increased with decreasing age at first intercourse , but this effect disappeared after adjusting for the number of female partners . Prior infection with gonorrhea was positively associated with risk ( odds ratio = 1.50 ; 95 % confidence interval : 1.0 , 2.2 ) , but no effect was seen among men with other sexually transmitted diseases . No relation between lifetime frequency of sexual intercourse and risk of prostate cancer was apparent . These findings are consistent with previous studies that support an infectious etiology for prostate cancer OBJECTIVES To determine the risk factors for the self-reported history of prostatitis and to determine whether a self-reported history of prostatitis is related to the diagnosis of prostate cancer . METHODS R and om digit dialing was used to select a group of controls aged 40 to 64 years without prostate cancer matched by age with a group of patients with prostate cancer in a study on the epidemiology of prostate cancer . Controls were divided into those who reported a diagnosis of prostatitis ( cases ) and those who denied ever having had prostatitis ( controls ) . We adjusted for the time from a prostatitis diagnosis to the in-person interview . We also compared the number of men with a prostatitis diagnosis to the number of men diagnosed and not diagnosed with prostate cancer . RESULTS Of the 645 control men without a history of prostate cancer , 58 ( 9.0 % ) reported a diagnosis of prostatitis . The men with prostatitis had a mean age of 39.5 years at diagnosis . The urinary symptoms among prostatitis cases and controls was similar . Prostatitis cases more frequently reported urinary ( P < or = 0.05 ) or urethral infections ( P < or = 0.01 ) before diagnosis . Men with prostatitis were more likely to have procedures aim ed at diagnosing both prostatic and other diseases . Men with prostate cancer reported a diagnosis of prostatitis more often than the noncancer controls ( 13.6 % versus 9.0 % ) . After controlling for the number of prostate-specific antigen tests this difference disappeared . CONCLUSIONS Nine percent of a r and omly selected group of middle-aged men reported they had been diagnosed with prostatitis . The prevalence of a prostatitis diagnosis is similar in men with and without prostate cancer Background : Sexually transmissible infections ( STI ) have been variably associated with increased risks of prostate cancer , largely in case-control studies . Methods : In the Prostate , Lung , Colorectal , and Ovarian Cancer Screening Trial ,
Output:
| Conclusions : Significant correlations were revealed among prostatitis , BPH and PCa .
Prostatitis or BPH could lead to escalating risks of PCa .
Meanwhile , people with a history of prostatitis might be more vulnerable to BPH |
MS212123 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Background & Aims In patients with gastroesophageal reflux disease ( GERD ) and excessive belching , most belches are supragastric , and can induce reflux episodes and worsen GERD . Supragastric belching ( SGB ) might be reduced with diaphragmatic breathing exercises . We investigated whether diaphragmatic breathing therapy is effective in reducing belching and proton pump inhibitor (PPI)‐refractory gastroesophageal reflux symptoms . Methods We performed a prospect i ve study of 36 consecutive patients with GERD refractory to PPI therapy and a belching visual analogue scale ( VAS ) score of 6 or more , seen at a gastroenterology clinic at a tertiary hospital in Singapore from April 2015 through October 2016 . Patients underwent high‐resolution manometry and 24‐hour pH‐impedance studies while they were off PPIs . Fifteen patients were placed on a st and ardized diaphragmatic breathing exercise protocol ( treatment group ) and completed question naires at baseline , after diaphragmatic breathing therapy , and 4 months after the therapy ended . Twenty‐one patients were placed on a waitlist ( control subjects ) , completed the same question naires with an additional question naire after their waitlist period , and eventually received diaphragmatic breathing therapy . The primary outcome was reduction in belching VAS by 50 % or more after treatment . Secondary outcomes included GERD symptoms ( evaluated using the reflux disease question naire ) and quality of life ( QoL ) scores , determined from the Reflux‐Qual Short Form and EuroQoL‐VAS . Results Nine of the 15 patients in the treatment group ( 60 % ) and none of the 21 control subjects achieved the primary outcome ( P < .001 ) . In the treatment group , the mean belching VAS score decreased from 7.1 ± 1.5 at baseline to 3.5 ± 2.0 after diaphragmatic breathing therapy ; in the control group , the mean VAS score was 7.6 ± 1.1 at baseline and 7.4 ± 1.3 after the waitlist period . Eighty percent of patients in the treatment group significantly reduced belching frequency compared with 19 % in control subjects ( P = .001 ) . Treatment significantly reduced symptoms of GERD ( the mean reflux disease question naire score decreased by 12.2 in the treatment group and 3.1 in the control group ; P = .01 ) . The treatment significantly increased QoL scores ( the mean Reflux‐Qual Short Form score increased by 15.4 in the treatment group and 5.2 in the control group ; P = .04 ) and mean EuroQoL‐VAS scores ( 15.7 increase in treatment group and 2.4 decrease in the control group ) . These changes were sustained at 4 months after treatment . In the end , 20 of the 36 patients who received diaphragmatic breathing therapy ( 55.6 % ) , all with excessive SGB , achieved the primary outcome . Conclusions In a prospect i ve study , we found a st and ardized protocol for diaphragmatic breathing to reduce belching and PPI‐refractory gastroesophageal reflux symptoms , and increase QoL in patients with PPI‐refractory GERD with belching — especially those with excessive SGB OBJECTIVES : The lower esophageal sphincter ( LES ) , surrounded by diaphragmatic muscle , prevents gastroesophageal reflux . When these structures become incompetent , gastric contents may cause gastroesophageal reflux disease ( GERD ) . For treatment , lifestyle interventions are always recommended . We hypothesized that by actively training the crura of the diaphragm as part of the LES using breathing training exercises , GERD can be positively influenced . METHODS : A prospect i ve r and omized controlled study was performed . Patients with non-erosive GERD or healed esophagitis without large hernia and /or previous surgery were included . Patients were r and omized and allocated either to active breathing training program or to a control group . Quality of life ( QoL ) , pH-metry , and on-dem and proton pump inhibitor ( PPI ) usage were assessed at baseline and after 4 weeks of training . For long-term follow-up , all patients were invited to continue active breathing training and were further assessed regarding QoL and PPI usage after 9 months . Paired and unpaired t-test was used for statistical analysis . RESULTS : Nineteen patients with non-erosive GERD or healed esophagitis were r and omized into two groups ( 10 training group and 9 control group ) . There was no difference in baseline patient characteristics between the groups and all patients finished the study . There was a significant decrease in time with a pH<4.0 in the training group ( 9.1±1.3 vs. 4.7±0.9 % ; P<0.05 ) , but there was no change in the control group . QoL scores improved significantly in the training group ( 13.4±1.98 before and 10.8±1.86 after training ; P<0.01 ) , but no changes in QoL were seen in the control group . At long-term follow-up at 9 months , patients who continued breathing exercise ( 11/19 ) showed a significant decrease in QoL scores and PPI usage ( 15.1±2.2 vs. 9.7±1.6 ; 98±34 vs. 25±12 mg/week , respectively ; P<0.05 ) , whereas patients who did not train had no long-term effect . CONCLUSIONS : We show that actively training the diaphragm by breathing exercise can improve GERD as assessed by pH-metry , QoL scores and PPI usage . This non-pharmacological lifestyle intervention could help to reduce the disease burden of GERD The crural diaphragm ( CD ) is an essential component of the esophagogastric junction ( EGJ ) , and inspiratory exercises may modify its function . This study 's goal is to verify if inspiratory muscle training ( IMT ) improves EGJ motility and gastroesophageal reflux ( GER ) . Twelve GER disease [ GERD ; 7 males , 20 - 47 yr , 9 esophagitis , and 3 nonerosive reflex disease ( NERD ) ] and 7 healthy volunteers ( 3 males , 20 - 41 yr ) performed esophageal pH monitoring , manometry , and heart rate variability ( HRV ) studies . A 6-cm sleeve catheter measured average EGJ pressure during resting , peak inspiratory EGJ pressures during sinus arrhythmia maneuver ( SAM ) and inhalations under 17- , 35- , and 70-cmH2O loads ( TH maneuvers ) , and along 1 h after a meal . GERD patients entered a 5-days-a-week IMT program . One author scored heartburn and regurgitation before and after IMT . IMT increased average EGJ pressure ( 19.7 ± 2.4 vs. 29.5 ± 2.1 mmHg ; P < 0.001 ) and inspiratory EGJ pressure during SAM ( 89.6 ± 7.6 vs. 125.6 ± 13.3 mmHg ; P = 0.001 ) and during TH maneuvers . The EGJ-pressure gain across 35- and 70-cmH2O loads was lower for GERD volunteers . The number and cumulative duration of the transient lower esophageal sphincter relaxations decreased after IMT . Proximal progression of GER decreased after IMT but not the distal acid exposure . Low-frequency power increased after IMT and the higher its increment the lower the increment of supine acid exposure . IMT decreased heartburn and regurgitation scores . In conclusion , IMT improved EGJ pressure , reduced GER proximal progression , and reduced GERD symptoms . Some GERD patients have a CD failure , and IMT may prove beneficial as a GERD add-on treatment The treatment of gastroesophageal reflux disease may be clinical or surgical . The clinical consists basically of the use of drugs ; however , there are new techniques to complement this treatment , osteopathic intervention in the diaphragmatic muscle is one these . The objective of the study is to compare pressure values in the examination of esophageal manometry of the lower esophageal sphincter ( LES ) before and immediately after osteopathic intervention in the diaphragm muscle . Thirty-eight patients with gastroesophageal reflux disease - 16 su bmi tted to sham technique and 22 su bmi tted osteopathic technique - were r and omly selected . The average respiratory pressure ( ARP ) and the maximum expiratory pressure ( MEP ) of the LES were measured by manometry before and after osteopathic technique at the point of highest pressure . Statistical analysis was performed using the Student 's t-test and Mann-Whitney , and magnitude of the technique proposed was measured using the Cohen 's index . Statistically significant difference in the osteopathic technique was found in three out of four in relation to the group of patients who performed the sham technique for the following measures of LES pressure : ARP with P= 0.027 . The MEP had no statistical difference ( P= 0.146 ) . The values of Cohen d for the same measures were : ARP with d= 0.80 and MEP d= 0.52 . Osteopathic manipulative technique produces a positive increment in the LES region soon after its performance
Output:
| The results of meta- analysis indicate that breathing exercises can improve pressure generated by the lower oesophageal sphincter ( LES ) , and a statistically significant difference was observed .
The possible mechanism behind this is the enhancement of the anti-regurgitation barrier [ especially crural diaphragm ( CD ) tension ] .
CONCLUSIONS To some extent , breathing exercises can relieve the symptoms of patients with GERD |
MS212124 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: The aim of this study was to evaluate the efficacy of two desensitizing agents in the reduction of dentin hypersensitivity in a r and omized , double-blind , split-mouth clinical trial . Seventy-seven teeth from 13 patients that presented some degree of sensitivity to probing and /or air stimulation were treated with one of the following desensitizing agents : Oxa-Gel ( G1 ) , Sensi Kill ( G2 ) and placebo gel ( G3 - control ) . According to paired t-test , all treatments , even the placebo gel , were capable of reducing sensitivity scores for both stimuli . Analysis of data by ANOVA and Tukey 's test ( ? = 0.05 ) showed that the sensitivity scores were significantly lower only for Sensi Kill in comparison to the other products ( Oxa-Gel and placebo ) , when air stimulus was applied . It may be concluded that treatment with Sensi Kill presented a slightly better performance in reducing dentin hypersensitivity when compared to the other desensitizing agent INTRODUCTION Various methods and material s are used in the treatment of dentin hypersensitivity . The aim of this r and omized prospect i ve controlled clinical trial was to evaluate and compare the desensitizing effects of the neodymium-doped yttrium aluminium garnet ( Nd : YAG ) laser and fluoride varnish by considering the degree of pre- and posttreatment pain , discomfort , and functional complications . METHODS Twenty patients with clinical ly diagnosed cervical dentin hypersensitive teeth were included and r and omly allocated to either the application of fluoride varnish ( group fluoride ) or Nd : YAG laser ( 100 mJ , 20 Hz ; group Nd : YAG ) . The assessment of pain and discomfort was performed by a visual analog scale after an air blast at baseline , immediately after treatment , and at patient visits on weeks 1 , 2 , 3 , and 4 . RESULTS Laser treatment result ed in significant improvements of discomfort immediately after treatment and after 1 week . At the 2- , 3- , and 4-week examination , the discomfort in group fluoride decreased up to nearly 75 % to 85 % of baseline scores , whereas the effect of the laser stayed nearly unchanged . The visual analog scale scores for pain at 4 weeks examination were significantly lower in the fluoride group compared with those in the laser group ( p < 0.05 ) . CONCLUSIONS Nd : YAG laser is a suitable tool for the immediately successful reduction of dentinal hypersensitivity and has better patient satisfaction and shorter treatment time OBJECTIVE Dentin hypersensitivity , or what patients may describe as " sensitive teeth , " is defined as a short , sharp pain arising from exposed dentin in response to thermal , evaporative , tactile , electrical , osmotic or chemical stimuli . It is widely accepted that dentin hypersensitivity is an uncomfortable condition that also affects function and quality of life . This study determines the differences in efficiency of three desensitizing products when compared with a placebo . METHODS A r and omized controlled clinical trial was conducted to compare three different professional dentin desensitizer agents in 52 patients . The age and sex of the patients was recorded . Gluma Desensitizer ( Heraeus Kulzer ) , UltraEZ ( Ultradent Products , Inc ) and Duraphat ( Colgate Oral Pharmaceuticals , Inc , New York , NY , USA ) were used as desensitizer agents and distilled water was used as the placebo . The baseline measurement of the dentin hypersensitivity was made by using a visual analog scale ( VAS ) . Twenty-four hours and seven days after application of the desensitizer agents and placebo , a new VAS analysis was conducted for patients ' sensitivity level . The desensitizer agents were compared in terms of mean values , and ANOVA was used for testing differences among the groups ( p<0.05 ) . RESULTS The results showed that the mean pain scores of the placebo group were significantly higher than that of the study groups ( p<0.05 ) . The VAS analysis revealed a significant decrease in dentin hypersensitivity over time with the use of agents ( p<0.05 ) . No statistically significant difference was found among the three desensitizing agents ( p>0.05 ) . CONCLUSIONS These three desensitizing agents , which contain different active ingredients , were effective in relieving dentin hypersensitivity . However , no superiority was found in dentin sensitivity relief among the agents OBJECTIVE The advent of dental lasers has raised another possible treatment option for dentine hypersensitivity ( DH ) and has become a research interest in the last decades . The aim of this r and omized , controlled , double-blind , split mouth , clinical study was to evaluate and compare the desensitizing effects of erbium , chromium-doped : yttrium , sc and ium , gallium and garnet ( Er , Cr : YSGG ) to galium-aluminium-arsenide ( GaAlAs ) laser on DH . METHODS Fifty-one patients participated in this study for a total of 174 teeth . DH was assessed for all groups with a visual analog scale . For each patient , the teeth were r and omized to three groups . In the diode laser group , sensitive teeth were irradiated with the GaAlAs laser at 8.5J/cm(2 ) energy density . In the Er , Cr : YSGG laser group , sensitive teeth were irradiated with Er , Cr : YSGG laser in the hard tissue mode using a none-contact probe at an energy level of 0.25W and repetition rate of 20Hz , 0 % water and 10 % air . In the control group no treatment was performed . Treatment time was 60s for GaAlAs laser and 30s for Er , Cr : YSGG laser . RESULTS When compared with the control group and baseline data , in both laser groups , laser irradiation provided a desensitizing effect immediately after treatment and this effect was maintained throughout the study ( p<0.05 ) . No significant differences between Er , Cr : YSGG and GaAlAs laser groups were found at any follow-up examination ( p>0.05 ) . CONCLUSION Based on these findings , it may be concluded that both Er , Cr : YSGG and GaAlAs lasers were effective in the treatment of DH following a single application UNLABELLED The dentin hypersensitivity is a painful condition rather prevalent in the general population . There are several ways of treatment for such condition , including the low intensity lasers . The proposal of this study was to verify the effectiveness of the Gallium-Aluminum-Arsenide diode laser in the treatment of this painful condition , using a placebo as control . MATERIAL S AND METHODS Thirty-two patients were selected , 22 females and 10 males , with ages ranging from 20 to 52 years old . The 32 patients were r and omly distributed into two groups , treated and control ; the sample consisted of 68 teeth , 35 in the treated group and 33 in the control group . The treated group was exposed to six laser applications with intervals from 48 to 72 hours , and the control group received , as placebo , applications of a curing light . RESULTS A significant reduction was observed in the pain condition between the initial phase and after six laser applications ; however , such reduction could also be observed for the control group exposed to the placebo . CONCLUSION Therapy with the low intensity Gallium-Aluminum-Arsenide laser - AsGaAl induces a statistically significant reduction in the painful condition after each application and between the beginning and end of treatment , although there was no statistically significant difference between the treated group ( laser ) and the control group ( placebo ) at the end of treatment and after the mediate evaluation results ( after 6 weeks ) , this way impairing the real measurement of laser effectiveness and placebo effect OBJECTIVES The purpose of this study was to evaluate and compare clinical ly the efficacy of desensitizer toothpaste alone and in combination with the diode laser in the management of dentin hypersensitivity ( DH ) , as well as both the immediate and late therapeutic effects on teeth with gingival recessions . MATERIAL S AND METHODS In total , 52 teeth diagnosed with DH in 13 ( seven women , six men , aged 16 - 48 years ) healthy adult patients were included in this study , and teeth were r and omly divided equally into two groups : the test group , which received treatment with desensitizer toothpaste and GaAlAs ( diode ) laser , and the control group , treated with desensitizer toothpaste . DH was assessed by means of an air stimulus , and a visual analogue scale ( VAS ) was used to measure DH . The selected teeth in the test group received laser therapy for three sessions . Teeth subjected to diode-laser treatment were irradiated at 100 mW for 25 sec at 808 nm , with continuous-emission , noncontact mode , perpendicular to the surface , with scanning movements on the region of exposed root surfaces . RESULTS Significant reduction of DH occurred at all times measured during the three treatment sessions in the test group . When compared with the means of the responses in the three treatment sessions of the two groups , the test group showed a higher degree of desensitization in teeth with gingival recession than did the control group ( p < 0.001 ) . The immediate and late therapeutic effects of the diode laser were more evident compared with those of desensitizer toothpaste . CONCLUSIONS Within the limitations of the present study , a significant effect of combined desensitizer toothpaste and diode laser therapy occurs in the treatment of desensitization of teeth with gingival recession . Desensitizer toothpaste appears to have the therapeutic potential to alleviate DH . Conversely , diode laser can be used to reduce DH This double-blind split-mouth trial with 16 adult patients investigated the ability of a dentine bonding agent ( DBA ) to reduce cervical dentine sensitivity . Following stimulation of pairs of teeth by conventional tactile and air blast stimuli , together with controlled evaporative and cold fluid stimuli , sensitivity was recorded using tactile threshold , visual-analogue scale ( VAS ) and short-form McGill pain question naire ( SFMPQ ) , prior to and 1 week following treatment with DBA . Prior to assessment , subjects recorded their perceived overall sensitivity using VAS and SFMPQ . Application of each stimulus was separated by 10 min . Sensitivity was recorded by a clinician blinded to the treatment status of each tooth . The control tooth was treated by applying DBA to coronal enamel . Dietary information was collected after the post-treatment assessment . There was a significant ( p<0.05 ) improvement in tactile threshold and air flow and air blast VAS scores , together with reductions in sensitivity to evaporative stimuli when assessed by SFMPQ . Treatment response was not influenced by the subjects ' age , gender , diet , use of fluoride-containing or silica-based toothpastes or fluoride mouthwashes , or a history of previous sensitivity treatment . It is concluded that topical application of DBA is an effective way to reduce cervical dentine sensitivity This study compares two commercially-available products for treating dentine sensitivity , Duraphat , a fluoride varnish , and SuperSeal , an oxalate preparation . 48 patients with dentine sensitivity were recruited . Sensitivity was assessed by visual analogue scales ( VAS ) to record pain following stimulation of exposed dentine surfaces by tactile stimulus ( sharp probe at 60 g force ) , thermal stimulus ( ethyl chloride ) and evaporative stimulus ( air drying ) . Patients were r and omised to treatment with either Duraphat or SuperSeal . After 4 weeks , sensitivity assessment s were repeated . Both treatments result ed in statistically significant reductions in VAS scores for all stimuli ( P<0.05 ) . However , analysis of covariance failed to identify statistically significant differences in the magnitude of reductions in sensitivity achieved by each of the products ( P>0.05 ) . The treatments had similar efficacy and both can be considered effective therapies for treating dentine sensitivity The aim of this clinical trial was to investigate the effects of topical applications of Gluma 3 Primer or Gluma 2000 conditioning solutions on hypersensitive erosion/abrasion lesions . Thirty-four patients were included in the trial with at least two teeth each presenting severe sensitivity . From a total of 116 teeth , 40 were treated with Gluma 3 Primer , 42 with Gluma 2000 Conditioner and 34 served as the control . Sensitivity was recorded as response to tactile and cold air stimuli prior to treatment as baseline , immediately after the topical application of the agents , after 1 week , 1 month and 6 months . Both Gluma groups showed a highly significant reduction in sensitivity between baseline and postoperative pain scores ( P < 0.05 ) and between the postoperative and the 1-week responses ( P < 0.05 ) . The sensitivity scores were not different between 1 week and 6 months . In the control group , no pain reduction was registered between baseline and up to 1-month recall . After 6 months , however , the sensitivity was spontaneously slightly reduced . At the end of the 6-month observation time , 29 Gluma and 31 Gluma 2000 treated teeth no longer showed dentin sensitivity OBJECTIVE The aim of the present study was to evaluate and compare the efficacy of CO(2 ) and Er : YAG lasers alone and in combination with topical sodium fluoride ( NaF ) in the management of dentine hypersensitivity . MATERIAL S AND METHODS A group of 50 patients presenting with a total of 420 hypersensitive teeth were r and omly allocated into five groups . Group 1 was treated with 2 % NaF , groups 2 and 3 were lased by a CO(2 ) ( 1 W , continuous wave mode , for 10 sec ) or Er : YAG ( 30 Hz , 60 mJ for 10 sec , without water/air spray ) laser , and groups 4 and 5 received NaF plus the CO(2 ) and the Er : YAG laser ,
Output:
| The results from network meta- analysis showed that most active treatment options had significantly better treatment outcome than placebo |
MS212125 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
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Input: OBJECTIVE To compare the effectiveness of zanamivir with oseltamivir for influenza A and B. METHODS 1113 patients with influenza A or B were enrolled in the 2006 - 2007 influenza season . The duration of fever ( temperature , > or=37.5 degrees C ) and the percentage of patients afebrile at 24 and 48 h after the first dose of zanamivir or oseltamivir were calculated . Virus persistence after zanamivir therapy was also evaluated . RESULTS There were marginally significant differences between the duration of fever after the first dose of zanamivir ( 31.8+/-18.4h ) and oseltamivir ( 35.5+/-23.9h ) for influenza A ( p<0.05 ) . The duration of fever after starting zanamivir therapy ( 35.8+/-22.4h ) was significantly shorter than that of oseltamivir ( 52.7+/-31.3h ) for influenza B ( p<0.001 ) . There were no significant differences between influenza A and B in the percentage of patients afebrile at 24 or 48 h after the first inhalation of zanamivir . The reisolation rate after zanamivir therapy showed marginally significant differences between influenza A and B ( < 0.05 ) . By multiple regression analysis , therapy ( zanamivir or oseltamivir ) was the major determinant affecting the duration of fever for influenza B. CONCLUSION Zanamivir therapy is more effective than oseltamivir for the treatment of influenza B infection Background —Influenza infection has been associated with increased risk of adverse cardiac and cerebral vascular outcomes . Oseltamivir , a treatment for influenza , has been shown to decrease the severity of an influenza episode , but few data exist regarding its potentially protective effect against recurrent vascular outcomes among influenza patients with a history of vascular disease . Methods and Results —Electronic healthcare service and pharmacy records for 37 482 TRICARE beneficiaries , aged 18 and older , with a coded history of cardiovascular ( CV ) disease and a subsequent diagnosis of influenza from October 1 , 2003 , through September 30 , 2007 , were examined . Subjects were grouped according to whether they had filled a prescription for oseltamivir within 2 days of their influenza diagnosis . The incidence of recurrent CV events within 30 days after the influenza diagnosis among oseltavmivir-treated and untreated subjects was 8.5 % and 21.2 % , respectively ( P<0.005 ) . Subject age was a persistent and significant contributor to the likelihood of recurrent CV outcomes . After controlling for the differences in demographics among treated and untreated cohorts using a propensity-scored logistic regression model , a statistically significant protective effect was associated with oseltamivir treatment ( odds ratio , 0.417 ; 95 % CI , 0.349 to 0.498 ) . Conclusions —Our findings suggests that oseltamivir treatment for influenza is associated with significant decrease in the risk of recurrent CV events in subjects with a history of CV disease . These findings merit confirmation in further prospect i ve and controlled studies . Meanwhile , in patients with CV disease , strict adherence with current practice guidelines for prevention and treatment of influenza is recommended Background The aim of this study was to investigate factors affecting clinical outcomes of adults hospitalised with severe seasonal influenza . Methods A prospect i ve , observational cohort study was conducted over 24 months ( 2007–2008 ) in two acute , general hospitals . Consecutive , hospitalised adult patients were recruited and followed once their laboratory diagnosis of influenza A/B was established ( based on viral antigen detection and virus isolation from nasopharyngeal aspirates collected per protocol ) . Outcomes studied included in-hospital death , length of stay and duration of oxygen therapy . Factors affecting outcomes were analysed using multivariate Cox proportional hazards models . Sequencing analysis on the neuraminidase gene was performed for available H1N1 isolates . Results 754 patients were studied ( influenza A , n=539 ; > 75 % H3N2 ) . Their mean age was 70±18 years ; co-morbidities and serious complications were common ( 61–77 % ) . Supplemental oxygen and ventilatory support was required in 401 ( 53.2 % ) and 41 ( 5.4 % ) patients , respectively . 39 ( 5.2 % ) patients died ; pneumonia , respiratory failure and sepsis were the causes . 395 ( 52 % ) patients received antiviral ( oseltamivir ) treatment . Omission of antiviral treatment was associated with delayed presentation or negative antigen detection results . The mortality rate was 4.56 and 7.42 per 1000 patient-days in the treated and untreated patients , respectively ; among those with co-morbidities , it was 5.62 and 11.64 per 1000 patient-days , respectively . In multivariate analysis , antiviral use was associated with reduced risk of death ( adjusted HR ( aHR ) 0.27 ( 95 % CI 0.13 to 0.55 ) ; p<0.001 ) . Improved survival was observed with treatment started within 4 days from onset . Earlier hospital discharge ( aHR 1.28 ( 95 % CI 1.04 to 1.57 ) ; p=0.019 ) and faster discontinuation of oxygen therapy ( aHR 1.30 ( 95 % CI 1.01 to 1.69 ) ; p=0.043 ) was associated with early treatment within 2 days . Few ( n=15 ) H1N1 isolates in this cohort had the H275Y mutation . Conclusions Antiviral treatment for severe influenza is associated with reduced mortality and improved clinical outcomes Oseltamivir has been used for treatment of influenza A and B infections , but recent reports documented that it was less active against the latter . We compared the effectiveness of oseltamivir in children between laboratory confirmed influenza A and B over 4 influenza seasons from 2001 to 2005 in a pediatric clinic in Japan . Among 1,848 patients screened , 299 influenza A and 209 influenza B patients were administered oseltamivir ( treated groups ) , and 28 influenza A and 66 influenza B patients were assigned as non-treated groups . The duration of fever , defined as period when patients had the maximum temperature higher than 37.5 degrees C in three-time measurements in a day after the clinic visit , was evaluated among the four groups . In uni-variate analysis , the duration of fever was shorter for treated group than non-treated for influenza A ( 1.8 + /- 0.9 days vs 2.6 + /- 1.3 days , p < 0.01 ) , but it was not significant for influenza B ( 2.4 + /- 1.3 days vs 2.8 + /- 1.2 days , p = 0.9 ) . The fever duration was longer in treated influenza B than A patients ( p < 0.01 ) . Multi-variate analysis indicated younger age ( < 6 years old ) and higher body temperature at the clinic visit prolonged the duration of fever . Adjusted average duration of fever indicated that oseltamivir was effective for both types , but more effective on influenza A , and the benefit increased for younger children . Our data provide evidence that oseltamivir is beneficial for influenza infections , but the effectiveness is differed by type and age BACKGROUND To compare the effectiveness of oseltamivir for treatment of influenza A and influenza B , we conducted a prospect i ve , multicenter study of the 2003 - 2004 and 2004 - 2005 influenza seasons . The study included 3351 patients in whom influenza had been diagnosed by use of an antigen detection test kit . METHODS Oseltamivir was administered to 1818 patients with influenza A and 1485 patients with influenza B. No anti-influenza drugs were administered to 21 patients with influenza A or to 27 patients with influenza B. Patients receiving oseltamivir therapy were divided into 4 groups according to the time between the onset of fever ( temperature , > or = 37.5 degrees C ) and administration of the first dose of oseltamivir ( 0 - 12 h , 13 - 24 h , 25 - 36 h , and 37 - 48 h ) . The patients were also divided into 4 subgroups on the basis of age ( 0 - 6 years , 7 - 15 years , 16 - 64 years , and > 64 years ) . Virus isolation was performed after completion of oseltamivir therapy for 44 patients with influenza A and 31 patients with influenza B. RESULTS The duration of fever was significantly shorter for patients with influenza A and B who were treated with oseltamivir than for patients who were not treated with an anti-influenza drug ( P<.001 for both ) . The time until the patient became afebrile after the initial administration of oseltamivir and the duration of fever were significantly longer for patients with influenza B than for patients with influenza A for the 0 - 12 h , 13 - 24 h , 25 - 36 h , and 37 - 48 h groups ( P<.001 ) and for all age groups ( P<.001 ) . After 4 - 6 days of oseltamivir therapy , the influenza B virus reisolation rate ( 51.6 % ) was significantly higher than the influenza A virus reisolation rate ( 15.9 % ) ( P<.001 ) . CONCLUSION Oseltamivir is less effective for influenza B than for influenza A with regard to duration of fever and virus persistence , irrespective of patient age or the timing of administration of the first dose Summary : Respiratory viruses ( RVs ) frequently cause severe respiratory disease in bone marrrow transplant ( BMT ) recipients . To evaluate the frequency of RV , nasal washes were collected year-round from BMT recipients with symptoms of upper respiratory tract infection ( URI ) . Direct immunofluorescence assay was performed for respiratory syncytial virus ( RSV ) , influenza ( Flu ) A and B , adenovirus and parainfluenza ( Paraflu ) virus . Patients with RSV pneumonia or with upper RSV infection , but considered at high risk for developing RSV pneumonia received aerosolized ribavirin . Oseltamivir was given to patients with influenza . A total of 179 patients had 392 episodes of URI . In all , 68 ( 38 % ) tested positive : RSV was detected in 18 patients ( 26.4 % ) , Flu B in 17 ( 25 % ) , Flu A in 11 ( 16.2 % ) and Paraflu in 7 ( 10.3 % ) . A total of 14 patients ( 20.6 % ) had multiple RV infections or coinfection . RSV pneumonia developed in 55.5 % of the patients with RSV-URI . One of the 15 patients ( 6.6 % ) with RSV pneumonia died . Influenza pneumonia was diagnosed in three patients ( 7.3 % ) . RSV and influenza infections peaked in fall – winter and winter – spring months , respectively . We observed decreased rates of influenza and parainfluenza pneumonia and low mortality because of RSV pneumonia . The role of antiviral interventions such as aerosolized ribavirin and new neuraminidase inhibitors remains to be defined in r and omized trials Abstract Background The goal of this study was to characterize viral loads and factors affecting viral clearance in persons with severe influenza Methods This was a 1-year prospect i ve , observational study involving consecutive adults hospitalized with influenza . Nasal and throat swabs were collected at presentation , then daily until 1 week after symptom onset . Real-time reverse-transcriptase polymerase chain reaction to determine viral RNA concentration and virus isolation were performed . Viral RNA concentration was analyzed using multiple linear or logistic regressions or mixed-effect models Results One hundred forty-seven in patients with influenza A ( H3N2 ) infection were studied ( mean age ± st and ard deviation , 72±16 years ) . Viral RNA concentration at presentation positively correlated with symptom scores and was significantly higher than that among time-matched out patients ( control subjects ) . Patients with major comorbidities had high viral RNA concentration even when presenting > 2 days after symptom onset ( mean ± st and ard deviation , 5.06±1.85 vs 3.62±2.13 log10 copies/mL ; P=.005 ; β , + 0.86 [ 95 % confidence interval , + 0.03 to + 1.68 ] ) . Viral RNA concentration demonstrated a nonlinear decrease with time ; 26 % of oseltamivir-treated and 57 % of untreated patients had RNA detected at 1 week after symptom onset . Oseltamivir started on or before symptom day 4 was independently associated with an accelerated decrease in viral RNA concentration ( mean β [ st and ard error ] , −1.19 [ 0.43 ] and −0.68 [ 0.33 ] log10 copies/mL for patients treated on day 1 and days 2–3 , respectively ; P<.05 ) and viral RNA clearance at 1 week ( odds ratio , 0.10 [ 95 % confidence interval , 0.
Output:
| From these observational studies , the summary estimates suggest that oseltamivir may reduce mortality , hospitalisation and duration of symptoms compared with no treatment .
Inhaled zanamivir may also reduce symptom duration and hospitalisations , but patients may experience more complications compared with no treatment .
Earlier treatment with antivirals is generally associated with better outcomes than later treatment . |
MS212126 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
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Input: To determine whether MBSR groups would help gay men living with HIV improve psychosocial functioning and increase mindfulness compared to treatment-as-usual ( TAU ) . Methods : 117 participants were r and omized 2:1 to MBSR or TAU . No new psychosocial or psychopharmacological interventions were initiated within 2 months of baseline . St and ardized question naires were administered pre- , postintervention and at 6 months . An intent-to-treat analysis found significant benefits of MBSR : at post-intervention and 6 months follow up , MBSR participants had significantly lower avoidance in IES and higher positive affect compared to controls . MBSR participants developed more mindfulness as measured by the Toronto Mindfulness Scale ( TMS ) including both TMS subscales , curiosity and decentering , at 8-week and 6 months . For the sample as a whole , increase in mindfulness was significantly correlated with reduction in avoidance , higher positive affect and improvement in depression at 6 months . MBSR has specific and clinical ly meaningful effects in this population Background : AIDS-related bereavement is a severe life stressor that may be particularly distressing to persons themselves infected with HIV . Increasing evidence suggests that psychological health is associated with disease progression , HIV-related symptoms , and mortality . Purpose : This study assessed change in health-related quality of life among HIV+ persons following a group intervention for coping with AIDS-related loss . Methods : The sample included 235 HIV+ men and women of diverse ethnicities and sexual orientations who had experienced an AIDS-related loss within the previous 2 years . Participants were r and omly assigned to a 12-week cognitive-behavioral bereavement coping group intervention or offered individual psychotherapy upon request . Quality of life was assessed at baseline and 2 weeks after the intervention . Results : Participants in the group intervention demonstrated improvements in general health-related and HIV-specific quality of life , while those in the comparison remained the same or deteriorated . Effect sizes indicated that the majority of change occurred in women . Conclusion : This bereavement group aim ed at improving coping with grief also had a positive impact on health-related quality of life among HIV+ men and women , and suggests that cognitive-behavioral interventions may have a broad impact on both emotional and physical health AIMS AND OBJECTIVES This study aim ed to examine the effects of nurse-delivered home visits combined with telephone intervention on medication adherence , and quality of life in HIV-infected heroin users . BACKGROUND Drug use is consistently reported as a risk factor for medication non-adherence in HIV-infected people . DESIGN An experimental , pretests and post-tests , design was used : baseline and at eight months . METHODS A sample of 116 participants was recruited from three antiretroviral treatment sites , and 98 participants completed the study . They were r and omly assigned to two groups : 58 in the experimental group and 58 in the control group . The experimental group received nurse-delivered home visits combined with telephone intervention over eight months , while the control group only received routine care . The question naire of Community Programs for Clinical Research on AIDS ( CPCRA ) Antiretroviral Medication Self-Report was used to assess levels of adherence , while quality of life and depression were evaluated using Chinese versions of World Health Organization Quality of Life Instrument-Abbreviated version ( WHOQOL-BREF ) and Self-rating Depression Scale , respectively . Data were obtained at baseline and eight months . RESULTS At the end of eight months , participants in the experimental group were more likely to report taking 100 % of pills ( Fisher 's exact = 14.3 , p = 0.0001 ) and taking pills on time ( Fisher 's exact = 18.64 , p = 0.0001 ) than those in the control group . There were significant effects of intervention in physical ( F = 10.47 , p = 0.002 ) , psychological ( F = 9.41 , p = 0.003 ) , social ( F = 4.09 , p = 0.046 ) and environmental ( F = 4.80 , p = 0.031 ) domains of WHOQOL and depression ( F = 5.58 , p = 0.02 ) . CONCLUSIONS Home visits and telephone calls are effective in promoting adherence to antiretroviral treatment and in improving the participants ' quality of life and depressive symptoms in HIV-infected heroin users . RELEVANCE TO CLINICAL PRACTICE It is important for nurses to recognise the issues of non-adherence to antiretroviral treatment in heroin users . Besides st and ard care , nurses should consider conducting home visits and telephone calls to ensure better health outcome of antiretroviral treatment in this population OBJECTIVE We tested the effects of a 10-week group-based cognitive-behavioral stress management/expressive-supportive therapy intervention ( CBSM+ ) and a time-matched individual psychoeducational condition for 330 women with AIDS reporting moderate to poor baseline quality of life ( QOL ) . The goal of this study was to examine treatment effects on total QOL and 11 QOL domains from baseline to post-intervention follow-up . METHODS Participants were assessed at baseline , r and omized to a treatment condition ( individual psychoeducation condition n=180 , group-based CBSM+ condition n=150 ) , participated in the intervention for 10 weeks and assessed again within 4 weeks following the intervention . QOL was measured using the Medical Outcomes Study -HIV-30 . RESULTS QOL scores increased over the course of both interventions for the total QOL score and three QOL domains : cognitive functioning , health distress and overall health perceptions . While women in the CBSM+ group condition showed a significant improvement in mental health QOL from pre- to post-intervention , women in the individual condition did not change . No changes were observed for energy/fatigue , health transition , single-item overall QOL , pain , physical well-being , role functioning or social functioning in either condition . CONCLUSION Results suggest that group-based CBSM+ and individual psychoeducational interventions are effective at improving certain aspects of QOL and that group-based CBSM+ may be particularly effective at increasing QOL related to mental health in this population of women with AIDS CONTEXT Proper adherence is essential to obtain the desired results of antiretroviral therapy ; thus , new interventional strategies for this purpose must be sought . OBJECTIVE Comparison of 2 interventions , one conducted by a health professional and the other by a peer ( patient on antiretroviral therapy ) , to improve adherence to antiretroviral therapy . DESIGN AND SETTING In 2003 , a r and omized , concurrent , follow-up study was conducted at 3 hospitals . PARTICIPANTS Patients were recruited consecutively at infectious disease visits scheduled to monitor their disease from May to September 2003 . A sealed envelope was used to assign patients to each intervention group . A previous phase was conducted to unify data collection , and the intervention consisted of 4 visits at weeks 0 , 8 , 16 , and 24 . RESULTS Among the 240 patients included , 198 completed follow-up , and in 11 of these , treatment was interrupted at the doctor 's decision . At baseline , 46.8 % were classified as adherent . Multilevel analysis showed that as the visits progressed , the probability of adhering to treatment increased ( OR 1.23 ; P<.01 ) . Although differences were not significant , the group treated by a peer showed better results than the group treated by a health professional ( OR 1.60 ; P=0.25 ) . A lower probability of antiretroviral adherence was observed in patients receiving a drug combination including a protease inhibitor ( OR 0.27 ; P<0.01 ) and in those with psychological distress ( OR 0.44 ; P=0.03 ) . Patients with a higher score on the physical quality of life index ( OR 1.05 ; P<0.01 ) presented a higher probability of adherence . CONCLUSIONS The psychoeducational intervention studied is viable and effective for improving antiretroviral adherence . When the intervention is conducted by a peer the results are at least as good as those obtained by a health professional , and this implies cost-saving for the health system CONTEXT In order for patients to benefit from a multidisciplinary treatment approach , diverse providers must communicate on patient care . OBJECTIVE We sought to examine the effect of information exchange across multidisciplinary human immunodeficiency virus ( HIV ) care providers on patient health outcomes . DESIGN R and omized controlled trial , r and omized at the patient level . SETTING Six infectious disease clinics paired with 9 ancillary care setting s ( eg , HIV case management ) . PARTICIPANTS Two hundred fifty-four patients with HIV receiving care at the infectious disease clinics . INTERVENTION Health information was exchanged for 2 years per patient between medical and ancillary care providers using electronic health records and printouts inserted into charts . Medical care providers gave ancillary care providers HIV viral loads , CD4 values , current medications , and appointment attendance . Ancillary care providers gave medical providers the information on medication adherence and major changes ( eg , loss of housing ) . MAIN OUTCOME MEASURES We abstract ed from medical records HIV viral loads , CD4 counts , and antiretroviral medication prescriptions before and during the intervention . From 0- , 12- , and 24-month patient surveys , we assessed hospitalizations , emergency department use , and health-related quality of life measured by the Medical Outcomes Study Short Form-36 ( SF-36 ) . RESULTS No statistically significant differences between cases and controls were found across time for the following : proportion with suppressed viral load , changes in viral load or CD4 values , patients being prescribed antiretroviral medication , hospitalizations , emergency department visits , or any scale of the SF-36 . Trends were mixed but leaned toward better health for control participants . CONCLUSIONS The exchange of this specific set of information between HIV medical and ancillary care providers was neutral on a variety of patient health outcomes Objective Our objective was to examine the effects of exercise training ( EXS ) on quality of life ( QoL ) in highly active antiretroviral therapy (HAART)-treated HIV-positive ( HIV+ ) subjects with body fat redistribution ( BFR ) in Rw and a. Methods The effects of a r and omised controlled trial of EXS on QoL were measured using World Health Organisation Quality of Life (WHOQOL)-BREF in HIV+ subjects with BFR r and omised to EXS ( n = 50 ; BFR + EXS ) or no exercise training ( n = 50 ; BFR + noEXS ) . Results At 6 months , scores on the psychological [ 1.3 ( 0.3 ) vs. 0.5 ( 0.1 ) ; P < 0.0001 ] , independence [ 0.6 ( 0.1 ) vs. 0.0 ( 0.0 ) ; P < 0.0001 ] , social relationships [ 0.6 ( 0.2 ) vs. 0.0 ( 0.0 ) ; P < 0.0001 ] and HIV HAART-specific QoL domains [ 1.4 ( 0.2 ) vs. −0.1 ( 0.2 ) ; P < 0.0001 ] improved more in BFR + EXS than BFR + noEXS group , respectively . Self-esteem [ 1.3 ( 0.8 ) vs. 0.1 ( 0.6 ) ; P < 0.001 ] , body image [ 1.5 ( 0.6 ) vs. 0.0 ( 0.5 ) ; P < 0.001 ] and emotional stress [ 1.6 ( 0.7 ) vs. 0.2 ( 0.5 ) ; P < 0.001 ] improved more in the BFR + EXS group than BFR + noEXS group , respectively . Psychological [ 1.5 ( 0.2 ) vs. 1.1 ( 0.3 ) ; P < 0.0001 ] , social relationship [ 0.8 ( 0.2 ) vs. 0.4 ( 0.2 ) ; P < 0.0001 ] , and HIV HAART-specific well-being [ 1.8 ( 0.2 ) vs. 1.0 ( 0.0 ) ; P < 0.0001 ] improved more in BFR + EXS female than male subjects . Conclusions Exercise training improved several components of QoL in HAART-treated HIV+ African subjects with BFR . Exercise training is an inexpensive and efficacious strategy for improving QoL in HIV+ African subjects , which may improve HAART adherence and treatment initiatives in re source -limited areas of sub-Saharan Africa OBJECTIVES We examined findings from a r and omized controlled intervention trial design ed to improve the quality of life of people living with HIV in Thail and . METHODS A total of 507 people living with HIV were recruited from 4 district hospitals in northern and northeastern Thail and and were r and omized to an intervention group ( n = 260 ) or a st and ard care group ( n = 247 ) . Computer-assisted personal interviews were administered at baseline and at 6 and 12 months . RESULTS At baseline , the characteristics of participants in the intervention and st and ard care conditions were comparable . The mixed-effects models used to assess the impact of the intervention revealed significant improvements in general health ( B = 2.51 ; P = .001 ) and mental health ( B = 1.57 ; P = .02 ) among participants in the intervention condition over 12 months
Output:
| Meta-analyses showed significant improvement in general health , mental health , physical function and environment domains of quality of life among intervention groups .
Conclusions Although the available evidence suggests that existing social and behavioral interventions can improve some quality of life domains , the quality of evidence was insufficient to support the notion that these interventions can improve the overall quality of life of HIV infected people receiving ART . |
MS212127 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: The hypothesis implicating the serotonergic system in the pathophysiology of obsessive-compulsive disorder ( OCD ) is supported by the therapeutic efficacy of selective serotonin reuptake inhibitors ( SSRIs ) . Since SSRIs act on the serotonin transporter ( 5-HTT ) , it has been suggested that the 5-HTT gene ( SCL6A4 ) could be a good c and i date for OCD . The SCL6A4 gene has a 44-bp insertion/deletion polymorphism in its promoter region ( 5-HTTLPR ) . Previous studies have revealed an association between OCD and the l allele . We analysed the 5-HTTLPR polymorphic system in 115 Mexican OCD patients and 136 controls . No significant association was found between l allele and OCD ( chi2 = 1.54 , d.f . = 1 , p = 0.21 ) . Furthermore , we assessed alternative methods that employ family-based design s in a sample of 43 trios . Haplotype-based haplotype relative risk and transmission disequilibrium analysis did not show a preferential transmission of l allele to OCD prob and s. Our results indicate the need to analyse larger sample s using family-based methods Results from family studies have suggested that obsessive‐compulsive disorder ( OCD ) is a genetically heterogeneous disorder and have emphasized the importance of identifying valid subgroups of patients . The current study focused on early‐onset OCD prob and s and examined the recurrence risks of OCD and tics among first‐degree family members . One hundred six children and adolescents with OCD were recruited from a specialty clinic for OCD and 44 control individuals without OCD were identified by r and om‐digit dialing . These 150 prob and s and their 465 first‐degree relatives were assessed by trained interviewers , using st and ardized semi‐structured interviews . Diagnoses were assigned according to DSM‐IV criteria by two experts blind to the prob and 's diagnosis , through the best‐estimate process . These data were analyzed using χ2 tests , t‐tests , logistic regression , and generalized estimating equations ( GEE ) . Case prob and s had a mean age of onset of OC symptoms of 6.7 years ( SD = 2.8 ) , and high comorbid rates with Tourette syndrome ( 33 % ) and chronic tics ( 13.2 % ) . Compared to control relatives , case relatives had higher age‐corrected recurrence risks of OCD ( 22.7 % vs. 0.9 % , odds ratio ( OR ) = 32.5 , 95 % confidence interval ( CI ) = 4.5–230.8 , P = 0.0005 ) , and chronic tics ( 11.6 % vs. 1.7 % , OR = 7.9 , 95 % CI = 1.9–33.1 , P = 0.005 ) . A comorbid diagnosis of tics in the relatives was the best predictor of their diagnosis of OCD ( OR = 7.35 , 95 % CI = 3.79–14.25 , P < 0.0001 ) . There was a significant correlation between the ages of onset of OCD in prob and s and their affected relatives . Childhood onset OCD is a highly familial disorder . Some early‐onset cases may represent a valid subgroup , with higher genetic loading and shared vulnerability with chronic tic disorders . © 2005 Wiley‐Liss , We analyzed the putative functional promoter polymorphism of the serotonin transporter ( 5-HTTLPR ) in two large autism spectrum disorder sample s and a control sample . A Hardy-Weinberg disequilibrium was detected for 5-HTTLPR in the unaffected founders of both autism spectrum disorder sample s and control sample s. When we lowered the total magnesium concentration in the polymerase chain reaction below levels reported in previously published studies , we observed a shift in relative allele frequencies and restoration of the Hardy-Weinberg equilibrium . Our data suggest that higher magnesium concentrations caused allele-dependent , non-r and om genotyping errors . Genotyping data obtained from the 2 mM magnesium protocol increased the significance of linkage and gave suggestive ( P=0.06 ) association with autism spectrum disorder , whereas the corrected genotypes of 5-HTTLPR provide no linkage information beyond the results we have previously published and no evidence of association with autism spectrum disorder . We present details regarding appropriate polymerase chain reaction conditions for the accurate genotyping of this polymorphism UNLABELLED Previous studies of serotonin transporter protein ( 5HTPR ) indexed in platelets by 3H-imipramine demonstrate reduction in children with comorbid obsessive-compulsive disorder ( OCD ) and Tourette 's syndrome ( TS ) . OBJECTIVE To use the 5HTPR selective lig and 3H-paroxetine and homogeneous diagnostic groups to reevaluate these findings . METHOD Platelet Kinetic binding parameters were evaluated using st and ard techniques from medication-free child and adolescent patients with OCD ( n = 18 ) , with TS ( n = 10 ) , and normal controls ( n = 19 ) . RESULTS Baseline binding capacity ( Bmax ) was significantly reduced in patients with OCD ( 1,342 + /- 952 fmol/mg ; protein p < .01 ) compared with normal controls ( 2,486 + /- 1309 fmol/mg ) and TS patients ( 2,420 + /- 1,069 fmol/mg ; p < .05 ) . Among OCD patients who were subsequently treated on an open-label basis with selective serotonin reuptake inhibitor ( SSRI ) , Bmax values at baseline differentiated between responders ( 1,718 + /- 1,041 fmol/mg ) and nonresponders ( 802 + /- 713 fmol/mg protein ; p < .05 ) . Response to SSRI was greatest in patients with a positive family history of OCD . Among responders ( n = 10 ) , baseline Yale-Brown Obsessive Compulsive Scale and Bmax were positively correlated ( r = .76 , p = .01 ) , as was Clinical Global Impression ( r = .67 , p = .03 ) . CONCLUSIONS Platelet 5HTPR capacity ( Bmax ) is reduced in children and adolescents with OCD , but not in those with TS . 5HTPR may be an indirect measure of basal serotonergic tone Peripheral measures of serotonergic and noradrenergic function were obtained in 29 obsessive-compulsive adolescents and 31 age- and sex-matched controls , as well as in a sub sample of 22 patients after five weeks of treatment with clomipramine hydrochloride ( 134 + /- 33 mg/d ) ( mean + /- SD ) given in a double-blind placebo-controlled trial . Drug-free obsessive-compulsive subjects did not differ from controls on measures of platelet serotonin and monoamine oxidase ( MAO ) activity , nor on plasma epinephrine or norepinephrine concentrations at rest and after a st and ard orthostatic challenge procedure . Compared with placebo , treatment with clomipramine was clinical ly effective and produced a marked decrease in platelet serotonin concentration , a trend toward a reduction in platelet MAO activity , and a rise in st and ing plasma norepinephrine . Clinical improvement during drug therapy was closely correlated with pretreatment platelet serotonin concentration and MAO activity , as well as with the decrease in both measures during clomipramine administration . This suggests that the effects of clomipramine on serotonin uptake may be essential to the antiobsessional action observed Family and twin studies have supported a strong genetic factor in the etiology of obsessive‐compulsive disorder ( OCD ) , although the precise mechanism of inheritance is unclear . Clinical and pharmacological studies have implicated the serotonergic and dopaminergic systems in disease pathogenesis . In this cross‐sectional study , we have examined the allelic and genotypic frequencies of a Val‐158‐Met substitution in the COMT gene , a 44‐base pair ( bp ) length variation in the regulatory region of the serotonin transporter gene ( 5‐HTTLPR ) and the T102C and C516 T variants in the serotonin receptor type 2A ( 5HT2A ) gene in 79 OCD patients and 202 control subjects . There were no observed differences in the frequencies of allele and genotype between patients and control groups for the COMT , the 5HTTLPR and the T102C 5HT2A gene polymorphisms . In contrast , a statistically significant difference between OCD patients and controls was observed on the genotypic distribution ( χ2 = 16.7 , 2df , P = 0.0002 ) and on the allelic frequencies ( χ2 = 15.8 , 1df , P = 0.00007 ) for the C516 T 5HT2A gene polymorphism . The results suggest that the C516 T variant of the 5HT2A gene may be one of the genetic risk factors for OCD in our sample . However , further studies using larger sample s and family based methods are recommended to confirm these findings
Output:
| In the overall meta- analysis we found no evidence of association between genetic variation at the 5-HTTLPR locus and OCD .
In the stratified meta-analyses , we demonstrated a significant association between the l-allele and OCD in family-based association studies and in studies involving children and Caucasians .
Our meta- analysis suggests the possibility that the l-allele may be associated with OCD in specific OCD subgroups such as childhood-onset OCD and in Caucasians .
Further meta-analyses based on individual patient data would be helpful in determining whether age of OCD onset , gender and the presence of comorbid illness ( e.g. , tics ) moderates the relationship between 5-HTTLPR and OCD |
MS212128 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Summary Two double-blind , r and omized , placebo-controlled multicentre studies were carried out to assess the efficacy and tolerability of subcutaneous ( s. c. ) injections of 1 - 3 mg and 1 - 8 mg sumatriptan , respectively , in the acute treatment of migraine . Data are presented from a total of 519 patients . In both studies , the primary endpoint of efficacy was a reduction in headache severity from severe or moderate to mild or no headache . All doses of sumatriptan were significantly more effective than placebo in relieving symptoms , and the response appeared to be dose-related ; an effective response to treatment was achieved within 30 min in 73 % of patients treated with 6 mg sumatriptan and 80 % of patients treated with 8 mg sumatriptan s. c. , compared with 22 % for placebo . Sumatriptan was well tolerated and the majority of adverse events were mild and transient . The most frequent complaint was irritation and pain at the site of injection . No changes in laboratory values were noted and ECG readings were unaltered by treatment . On the basis of these results , the 6 mg subcutaneous dose has been selected for further evaluation in large-scale studies BACKGROUND Sumatriptan is effective for the treatment of acute migraine . However , headache may recur in about 30 % of patients within 24 hours of successful treatment . OBJECTIVE To evaluate the efficacy of oral sumatriptan , 100 mg , in the treatment of headache recurring within 24 hours of achieving headache resolution with subcutaneous sumatriptan , 6 mg . STUDY DESIGN Subcutaneous sumatriptan was administered for up to 12 migraine attacks in a r and omized , double-blind , parallel-group study . Patients whose headache was completely resolved 90 minutes after subcutaneous dosing received either oral sumatriptan or placebo at the onset of recurrent headache . Patients whose headache was not completely resolved were offered rescue medication , including sumatriptan . Patients rated headache severity for 24 hours . SETTING Fifteen US outpatient clinics . MAIN OUTCOME MEASURE Percentage of patients with relief of recurrent headache and adverse events . RESULTS Approximately 90 % of patients achieved relief of headache ( severe or moderate headache reduced to mild or no headache ) by 90 minutes after unblinded subcutaneous administration of sumatriptan . Efficacy rates were at least 80 % regardless of whether the headache fulfilled the International Headache Society criteria for migraine . About 64 % of patients achieved complete relief . Oral sumatriptan , 100 mg , relieved moderate or severe recurrent headache within 4 hours in up to 81 % of patients . Oral sumatriptan administered as rescue medication to patients not headache-free did not relieve persistent headache . The incidence , pattern , and severity of adverse events after combined subcutaneous and oral administration of sumatriptan were similar to those after subcutaneous administration alone . CONCLUSIONS Oral sumatriptan was consistently effective in the treatment of headache recurrence Abstract Variability in patients ' response to interventions in pain and other clinical setting s is large . Many explanations such as trial methods , environment or culture have been proposed , but this paper sets out to show that the main cause of the variability may be r and om chance , and that if trials are small their estimate of magnitude of effect may be incorrect , simply because of the r and om play of chance . This is highly relevant to the questions of ‘ How large do trials have to be for statistical accuracy ? ’ and ‘ How large do trials have to be for their results to be clinical ly valid ? ’ The true underlying control event rate ( CER ) and experimental event rate ( EER ) were determined from single‐dose acute pain analgesic trials in over 5000 patients . Trial group size required to obtain statistically significant and clinical ly relevant ( 0.95 probability of number‐needed‐to‐treat within ±0.5 of its true value ) results were computed using these values . Ten thous and trials using these CER and EER values were simulated using varying group sizes to investigate the variation due to r and om chance alone . Most common analgesics have EERs in the range 0.4–0.6 and CER of about 0.19 . With such efficacy , to have a 90 % chance of obtaining a statistically significant result in the correct direction requires group sizes in the range 30–60 . For clinical relevance nearly 500 patients are required in each group . Only with an extremely effective drug ( EER>0.8 ) will we be reasonably sure of obtaining a clinical ly relevant NNT with commonly used group sizes of around 40 patients per treatment arm . The simulated trials showed substantial variation in CER and EER , with the probability of obtaining the correct values improving as group size increased . We contend that much of the variability in control and experimental event rates is due to r and om chance alone . Single small trials are unlikely to be correct . If we want to be sure of getting correct ( clinical ly relevant ) results in clinical trials we must study more patients . Credible estimates of clinical efficacy are only likely to come from large trials or from pooling multiple trials of conventional ( small ) size Objective : To evaluate the efficacy and safety of sumatriptan , a 5-HTa receptor agonist , in patients with menstruationassociated migraine . Methods : Two double-blind , placebo-controlled , singleattack parallel group studies of subcutaneous sumatriptan were conducted for the acute treatment of migraine . A retrospective analysis of 1104 patients produced 157 women who were treated for a menstruation-associated migraine ( defined as a migraine beginning between 1 day before and 4 days after the onset of menstrual flow ) and 512 women treated for nonmenstrual migraine . We excluded 435 other patients who were either male ( 123 ) , women with hysterectomies ( 260 ) , or women with missing data ( 52 ) . Patients with moderate or severe pain were treated with 6 mg subcutaneous sumatriptan or placebo . One hour after treatment , response rates of headache severity and associated symptoms were measured . Menstruation-associated migraine patients were compared to female patients with nonmenstrual migraine . Migraine recurrence was analyzed retrospectively for 24 hours . Results : At 1 hour , 80 % of the sumatriptan-treated menstrual-migraine patients had pain relief ( reduction of severe or moderate pain to mild or no pain ) , compared to 19 % of the placebo patients ( P < .001 ) . Sumatriptan also treated nausea and photophobia more effectively in menstrual-migraine patients than did placebo . Response rates for pain and associated symptoms were similar between patients with menstruation-associated and nonmenstrual migraines . Adverse effects were also similar between the groups . Conclusion : Sumatriptan was as effective and well tolerated for menstruation-associated migraine as it was for nonmenstrual migraine The results of the very first large-scale placebo-controlled dose-response trial with the novel selective 5-hydroxytryptamine1-like ( 5HT 1-like ) receptor agonist sumatriptan are presented . We studied the efficacy and tolerability of subcutaneous injections of 1 mg , 2 mg and 3 mg of sumatriptan in alleviating migraine attacks in a double-blind , placebo-controlled , parallel-group , multicentre clinical trial . Six-hundred and ninety patients were r and omized and 685 received study medication . At 30 min , reduction of headache severity to mild or none ( primary efficacy endpoint ) was achieved in 22 % ( 95 % CI : 15 - 28 % ) of placebo-treated patients and in 39 % ( CI : 31 - 46 % ) of patients treated with 1 mg sumatriptan , 44 % ( CI : 36 - 51 % ) treated with 2 mg sumatriptan and 55 % ( CI : 48 - 63 % ) treated with 3 mg sumatriptan . Differences from placebo were 17 % ( CI : 8 - 27 % ) for 1 mg sumatriptan , 22 % ( CI : 13 - 32 % ) for 2 mg sumatriptan and 34 % ( CI : 24 - 44 % ) for 3 mg sumatriptan ( p < 0.001 for all three comparisons ) . Other migraine symptoms were also more effectively treated by sumatriptan than by placebo . Subsequently , an open-label 3 mg dose subcutaneous sumatriptan was given to partial or non-responders . Thirty minutes after this open dose the response rate to sumatriptan had improved to between 70 and 80 % . Adverse events after sumatriptan were minor and short-lived . We conclude that subcutaneous sumatriptan is well tolerated in doses up to 3 + 3 mg and may rapidly abort migraine attacks This double-blind , placebo-controlled , multicenter , crossover study investigated the efficacy and tolerability of sumatriptan administered for up to three separate migraine attacks . One hundred twenty adults received sumatriptan ( SC , 6 mg ; three attacks ) and placebo ( one attack ) . Patients completed question naires assessing the impact of migraine on their lives and the performance of sumatriptan relative to their usual acute therapies . Sumatriptan statistically outperformed placebo on all efficacy measures , including pain severity ; presence/absence of nausea , vomiting , phonophobia , and photophobia ; rescue medication use ; and clinical disability . Efficacy was consistently maintained with repeated administration . For all attacks , pain relief 90 minutes postdose occurred in 86 % to 90 % of sumatriptan-treated patients , compared with 9 % to 38 % of placebo-treated patients . Sumatriptan was well tolerated , and the frequency and severity of adverse events did not change with repeated administration . Patients ' perceptions of sumatriptan were consistent with clinical data demonstrating the drug 's high degree of efficacy and tolerability OBJECTIVE To evaluate the impact of sumatriptan succinate injection compared with placebo on productivity loss during a migraine attack in the workplace . DESIGN R and omized , double-blind , placebo-controlled , parallel-group clinical trial . SETTING Fifteen clinical centers in the United States . PATIENTS One hundred thirty-five patients 18 years and older diagnosed as having migraine according to International Headache Society criteria . INTERVENTIONS Patients self-administered sumatriptan injection ( 6 mg ) or matching placebo to treat a moderate or severe migraine occurring within the first 4 hours of a minimum 8-hour work shift . MAIN OUTCOME MEASURES Mean productivity loss 2 hours after dosing and across the work shift ; percentages of patients returning to normal work performance within 2 hours after dosing and across the work shift ; percentages of patients experiencing headache relief ( reduction of moderate or severe predose pain to mild or no pain ) 1 and 2 hours after dosing . RESULTS Mean productivity loss was significantly ( P < or = .002 ) lower in the sumatriptan group compared with the placebo group both during the 2-hour postdose period ( sumatriptan , 39 minutes ; placebo , 54 minutes ) and across the work shift ( sumatriptan , 86 minutes ; placebo , 168 minutes ) . Significantly ( P<.001 ) greater percentages of patients in the sumatriptan group compared with the placebo group returned to normal work performance by 2 hours after dosing ( sumatriptan , 52 % ; placebo , 9 % ) and across the work shift ( sumatriptan , 66 % ; placebo , 18 % ) . Significantly ( P < or = .001 ) greater percentages of patients in the sumatriptan group compared with the placebo group experienced headache relief 1 hour after dosing ( sumatriptan , 69 % ; placebo , 18 % ) and 2 hours after dosing ( sumatriptan , 79 % ; placebo , 32 % ) . CONCLUSION Sumatriptan reduced migraine-associated productivity loss during a minimum 8-hour work shift by approximately 50 % compared with placebo and alleviated headache in more than three fourths of patients We compared the efficacy and safety of subcutaneous ( SC ) sumatriptan ( 6 mg ) with that of dihydroergotamine ( DHE ) nasal spray ( 1 mg plus optional 1 mg ) in the acute treatment of migraine . Two hundred sixty-six adult migraineurs ( International Headache Society criteria ) completed a multicenter , double-blind , double-dummy , cross-over study . Patients took SC sumatriptan for one attack and DHE nasal spray for the other in r and om order . Data from both treatment periods show that at all time points from 15 minutes , SC sumatriptan was significantly better than DHE nasal spray at providing both headache relief ( moderate/severe headache improving to mild/none ) and resolution of headache . Similarly , SC sumatriptan was superior to DHE nasal spray for the other efficacy end points assessed in the study . Patients reported that both treatments were well tolerated . Adverse events were reported by 43 % of patients taking SC sumatriptan and 22 % of patients taking DHE nasal spray . These were usually mild and transient . We conclude that subcutaneous sumatriptan has a faster onset of action than DHE nasal spray and provides greater relief of acute migraine symptoms . NEUROLOGY 1996;47 : 361 - OBJECTIVES : To investigate the efficacy of a second subcutaneous dose of 6 mg sumatriptan in the treatment of recurrence of headache after successful treatment of a migraine attack with an initial 6 mg dose . METHODS : In a prospect i ve , r and omised , placebo controlled , double blind , parallel group study ,
Output:
| Relief of headache-associated symptoms , including nausea , photophobia , and phonophobia , was greater with sumatriptan than with placebo , and use of rescue medication was lower with sumatriptan than placebo .
For the most part , adverse events were transient and mild and were more common with sumatriptan than placebo .
Subcutaneous sumatriptan is effective as an abortive treatment for acute migraine attacks , quickly relieving pain , nausea , photophobia , phonophobia , and functional disability , but is associated with increased adverse events |
MS212129 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
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Input: BACKGROUND Variations exist in the surgical techniques used for caesarean section and many have not been rigorously assessed in r and omised controlled trials . We aim ed to assess whether any surgical techniques were associated with improved outcomes for women and babies . METHODS CORONIS was a pragmatic international 2 × 2 × 2 × 2 × 2 non-regular fractional , factorial , unmasked , r and omised controlled trial that examined five elements of the caesarean section technique in intervention pairs . CORONIS was undertaken at 19 sites in Argentina , Chile , Ghana , India , Kenya , Pakistan , and Sudan . Each site was assigned to three of the five intervention pairs : blunt versus sharp abdominal entry ; exteriorisation of the uterus for repair versus intra-abdominal repair ; single-layer versus double-layer closure of the uterus ; closure versus non-closure of the peritoneum ( pelvic and parietal ) ; and chromic catgut versus polyglactin-910 for uterine repair . Pregnant women were eligible if they were to undergo their first or second caesarean section through a planned transverse abdominal incision . Women were r and omly assigned by a secure web-based number allocation system to one intervention from each of the three assigned pairs . All investigators , surgeons , and participants were unmasked to treatment allocation . The primary outcome was the composite of death , maternal infectious morbidity , further operative procedures , or blood transfusion ( > 1 unit ) up to the 6-week follow-up visit . Women were analysed in the groups into which they were allocated . The CORONIS Trial is registered with Current Controlled Trials : IS RCT N31089967 . FINDINGS Between May 20 , 2007 , and Dec 31 , 2010 , 15 935 women were recruited . There were no statistically significant differences within any of the intervention pairs for the primary outcome : blunt versus sharp entry risk ratio 1·03 ( 95 % CI 0·91 - 1·17 ) , exterior versus intra-abdominal repair 0·96 ( 0·84 - 1·08 ) , single-layer versus double-layer closure 0·96 ( 0·85 - 1·08 ) , closure versus non-closure 1·06 ( 0·94 - 1·20 ) , and chromic catgut versus polyglactin-910 0·90 ( 0·78 - 1·04 ) . 144 serious adverse events were reported , of which 26 were possibly related to the intervention . Most of the reported serious adverse events were known complications of surgery or complications of the reasons for the caesarean section . INTERPRETATION These findings suggest that any of these surgical techniques is acceptable . However , longer-term follow-up is needed to assess whether the absence of evidence of short-term effects will translate into an absence of long-term effects . FUNDING UK Medical Research Council and WHO OBJECTIVE A new technical variant of caesarean section was described a few years ago , which is characterised by blunt surgical preparation and simplified seam technique . A prospect i ve investigation compared the differences in the surgery and postoperative process as well as the rate of complications between this Misgav Ladach method and the conventional technique of Sectio . The individual postoperative well-being of the women was recorded by visual analog scales . - PATIENTS AND METHODS Women , whom realize the including criteria s ( first caesarean section , > /= 32 . week of pregnancy , one baby ) , were examined in this study over one year : 105 patients operated with the Misgav Ladach method and 67 conventionally operated patients . The patients were r and omized in a function of the first letter of the surname ( A-K : Misgav-Ladach method ; L-Z : classical technique ) . - RESULTS The surgical time from the cut to the seam was significantly shorter ( 29.8 vs. 49.3 min ; p < 0,001 ) in the Misgav Ladach group . There were no differences between the two methods in the rate of postoperative complications . The febrile morbidity was equivalent in both groups ( 7.6 % vs. 9 % ) , likewise the frequency of postoperative hematomas ( 3.8 % vs. 3 % ) . The postoperative period with consumption of analgetics was significantly longer in the group of conventionally operated patients ( 1.9 d vs. 2.4 d ; p < 0.01 ) . The postoperative presentness was estimated significantly better ( p < 0,.01 ) by the patients of the Misgav ladach group - probably caused by the significantly earlier mobilization ( p < 0.05 ) . - CONCLUSION The surgical technique described by Misgav and Ladach allows a safe execution of the caesarean section and represents an alternative to the conventional method . The duration of operation ( cut-seam-time ) was significantly shorter . The technique of less traumatising of tissue caused a significantly earlier mobilisation and a significantly shorter requirement of analgetics . The women estimated her postoperative physical condition as better 125 caesarean sections were performed at the Department of Obstetrics and Gynecology , Allgemeines Krankenhaus Celle , during the last 6 months of 1991 . The caesarean section rate was 13.4 % ( 930 deliveries in that period).--For closure of the uterotomy a two-layer suture was applied ( 62 patients ) as well as a one-layer suture , the modified Sarafoff suture ( 63 patients ) . Both techniques were used alternatively . We compared intraoperative and postoperative courses of the two groups of patients in a prospect i ve study . Between the 8th and 10th day after surgery an ultrasonic examination of the scar was performed . The data in both groups did not show any significant difference , except that the scar in the one-layer group was thinner .-- So , our results did not support an advantage of the one-layer suture as compared to the two-layer technique Aim . To compare Pfannenstiel-Kerr ( PKM ) and Misgav-Ladach ( MLM ) methods in terms of operation-related features and neonatal outcome in primary cesarean deliveries . Methods . A total of 180 pregnant women r and omized into PKM ( n = 90 ) or MLM ( n = 90 ) groups were included in this study . Primary outcome measures were total operative and extraction times , Apgar score , blood loss , wound complications , and the suture use . Secondary outcome measures were wound seroma and infection incidence , time of bowel restitution , and the perceived pain . Results . Total operation and extraction times were significantly shorter and less suture material was used in the MLM group than the PKM group ( p < 0.001 ) . Initially , higher scores obtained for 6 h-VAS in the MLM group ( p < 0.05 ) were normalized after 24 h of the operation . PKM and MLM were similar in terms of preoperative and postoperative levels of hemoglobin and hematocrit , wound complication , bowel restitution , fever , seroma , infection , wound dehiscence and the need for transfusion , antibiotic , and analgesics . Conclusion . The operation-related morbidity of the MLM and PKM for primary C/S seem to be comparable ; however , the MLM seems to be superior in terms of operation time and the amount of suture usage but inferior in pain scores in the early postoperative period OBJECTIVE To compare the effect of different suturing techniques in repeat caesarean section in terms of scar thickness , blood loss , operative time and scar dehiscence at the time of next caesarean section . STUDY DESIGN A r and omized double blinded trial . PLACE AND DURATION OF STUDY Obstetrics and Gynaecology Department of Bahawal Victoria Hospital , Bahawalpur , from June 2005 to June 2010 . METHODOLOGY Ninety patients undergoing repeat caesarean section were included and r and omly assigned to one of the three groups . Group A underwent one layer closure ; Group B underwent two layer closure while Group C underwent modified two layer closure of the uterine incision . Ultrasonographic evaluation of the scar thickness was performed at 6 weeks post operatively and longer follow-up was done in next caesarean for scar dehiscence . Frequency percentages were obtained and compared using chi-square test with significance at p < 0.05 . RESULTS In only 2 ( 6.6 % ) of modified two layer closure cases , it was necessary to use additional haemostatic sutures , compared with 16 ( 53 % ) of one layer closure group , and 10 ( 33 % ) of the two layer closure group . At 6 weeks , the mean car thickness in group C ( 17.08 + 1.635 mm ) was significantly greater ( p < 0.001 ) as compared to group A ( 13.19 + 1.32 mm ) and group B ( 14.58 + 1.18 mm ) . At long-term follow-up , only 1 ( 6 % ) case from group C showed the " uterine window " at the time of repeat caesarean section as compared to 3 ( 23 % ) in group A and 2 ( 14 % ) in group B. CONCLUSION Scar thickness was significantly increased with modified two layer closure when compared with traditional one and two layer closure of lower transverse uterine incision at the time of repeat caesarean section Design CORONIS is a pragmatic multicentre fractional factorial r and omised controlled trial and is being conducted in sites in Argentina , Chile , Ghana , India , Kenya , Pakistan and Sudan [ 1 ] . Women are eligible if they are undergoing their first or second caesarean section through a transverse abdominal incision . Five comparisons will be carried out using a 2 balanced incomplete block factorial design . Each woman is allocated THREE of the five pairs of interventions using a bespoke secure webbased r and omisation system ( with 24/7 automated backup telephone system ) hosted by the NPEU Clinical Trials Unit . The 5 pairs of interventions are : i. Blunt versus sharp abdominal entry ii . Exteriorisation of the uterus for repair versus intraabdominal repair iii . Single versus double layer closure of the uterus iv . Closure versus non-closure of the peritoneum ( pelvic and parietal ) v. Chromic catgut versus Polyglactin-910 for uterine repair Primary outcome : death or maternal infectious morbidity ( one or more of the following : antibiotic use for maternal febrile morbidity during postnatal hospital stay , antibiotic use for endometritis , wound infection or peritonitis ) or further operative procedures or blood transfusion . Sample size required : 15,000 women in total ; minimum 9,000 women per comparison pair In recent years Stark and colleagues ( 1 , 2 ) proposed the application to the cesarean section of a number of new surgical techniques adopted from various sources : the differences with respect to the traditional procedures were the Joel-Cohen methods for opening the abdomen , suturing the uterus in one layer , and non-closure of the visceral and parietal peritoneal layers . They demonstrated that this cesarean section procedure is safe , fast and has a low risk of postoperative complications in the mothers ( 2 ) and therefore this technique has been adopted in many centers . Nevertheless , the possible consequences of these changes on the short-term outcome of the newborn have never been evaluated . Cesarean section and maternal anesthesia are risk factors for the respiratory distress syndrome , transient tachypnea and respiratory depression in the newborn infants ( 3 ) and , therefore , we wanted to evaluate if a cesarean section technique presumably faster than the traditional procedure could improve the short-term outcome of the newborns Background Caesarean section is one of the most commonly performed operations on women throughout the world . Rates have increased in recent years – about 20–25 % in many developed countries . Rates in other parts of the world vary widely . A variety of surgical techniques for all elements of the caesarean section operation are in use . Many have not yet been rigorously evaluated in r and omised controlled trials , and it is not known whether any are associated with better outcomes for women and babies . Because huge numbers of women undergo caesarean section , even small differences in post-operative morbidity rates between techniques could translate into improved health for substantial numbers of women , and significant cost savings . Design CORONIS is a multicentre , fractional , factorial r and omised controlled trial and will be conducted in centres in Argentina , Ghana , India , Kenya , Pakistan and Sudan . Women are eligible if they are undergoing their first or second caesarean section through a transverse abdominal incision . Five comparisons will be carried out in one trial , using a 2 × 2 × 2 × 2 × 2 fractional factorial design . This design has rarely been used , but is appropriate for the evaluation of several procedures which will be used together in clinical practice . The interventions are : • Blunt versus sharp abdominal entry • Exteriorisation of the uterus for repair versus intra-abdominal repair • Single versus double layer closure of the uterus • Closure versus non-closure of the peritoneum ( pelvic and parietal ) • Chromic catgut versus Polyglactin-910 for uterine repair The primary outcome is death or maternal infectious morbidity ( one or more of the following : antibiotic use for maternal febrile morbidity during postnatal hospital stay , antibiotic use for endometritis , wound infection or peritonitis ) or further operative procedures ; or blood transfusion . The sample size required is 15,000 women in total ; at least 7,586 women in each comparison . Discussion Improvements in health from optimising caesarean section techniques are likely to be more significant in developing countries , because the rates of postoperative morbidity in these countries tend to be higher . More women could therefore benefit from improvements in techniques . Trial registration The COR
Output:
| There is increasing evidence that for many techniques , short-term maternal outcomes are equivalent . |
MS212130 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: Background Stepping impairments are associated with physical and cognitive decline in older adults and increased fall risk . Exercise interventions can reduce fall risk , but adherence is often low . A new exergame involving step training may provide an enjoyable exercise alternative for preventing falls in older people . Purpose To assess the feasibility and safety of unsupervised , home-based step pad training and determine the effectiveness of this intervention on stepping performance and associated fall risk in older people . Design Single-blinded two-arm r and omized controlled trial comparing step pad training with control ( no-intervention ) . Setting / Participants Thirty-seven older adults residing in independent-living units of a retirement village in Sydney , Australia . Intervention Intervention group ( IG ) participants were provided with a computerized step pad system connected to their TVs and played a step game as often as they liked ( with a recommended dose of 2–3 sessions per week for 15–20 minutes each ) for eight weeks . In addition , IG participants were asked to complete a choice stepping reaction time ( CSRT ) task once each week . Main Outcome Measures CSRT , the Physiological Profile Assessment ( PPA ) , neuropsychological and functional mobility measures were assessed at baseline and eight week follow-up . Results Thirty-two participants completed the study ( 86.5 % ) . IG participants played a median 2.75 sessions/week and no adverse events were reported . Compared to the control group , the IG significantly improved their CSRT ( F31,1 = 18.203 , p<.001 ) , PPA composite scores ( F31,1 = 12.706 , p = 0.001 ) , as well as the postural sway ( F31,1 = 4.226 , p = 0.049 ) and contrast sensitivity ( F31,1 = 4.415 , p = 0.044 ) PPA sub-component scores . In addition , the IG improved significantly in their dual-task ability as assessed by a timed up and go test/verbal fluency task ( F31,1 = 4.226 , p = 0.049 ) . Conclusions Step pad training can be safely undertaken at home to improve physical and cognitive parameters of fall risk in older people without major cognitive and physical impairments . Trial Registration Australian New Zeal and Clinical Trials Registry ACTRN12611001081909 Purpose Interactive cognitive-motor training ( ICMT ) requires individuals to perform both gross motor movements and complex information processing . This study investigated the effectiveness of ICMT on cognitive functions associated with falls in older adults . Methods A single-blinded r and omized controlled trial was conducted in community-dwelling older adults ( N = 90 , mean age 81.5±7 ) without major cognitive impairment . Participants in the intervention group ( IG ) played four stepping games that required them to divide attention , inhibit irrelevant stimuli , switch between tasks , rotate objects and make rapid decisions . The recommended minimum dose was three 20-minute sessions per week over a period of 16 weeks unsupervised at home . Participants in the control group ( CG ) received an evidence -based brochure on fall prevention . Measures of processing speed , attention/executive function ( EF ) , visuo-spatial ability , concerns about falling and depression were assessed before and after the intervention . Results Eighty-one participants ( 90 % ) attended re- assessment . There were no improvements with respect to the Stroop Stepping Test ( primary outcome ) in the intervention group . Compared to the CG , the IG improved significantly in measures of processing speed , visuo-spatial ability and concern about falling . Significant interactions were observed for measures of EF and divided attention , indicating group differences varied for different levels of the covariate with larger improvements in IG participants with poorer baseline performance . The interaction for depression showed no change for the IG but an increase in the CG for those with low depressive symptoms at baseline . Additionally , low and high-adherer groups differed in their baseline performance and responded differently to the intervention . Compared to high adherers , low adherers improved more in processing speed and visual scanning while high-adherers improved more in tasks related to EF . Conclusions This study shows that unsupervised stepping ICMT led to improvements in specific cognitive functions associated with falls in older people . Low adherers improved in less complex functions while high-adherers improved in EF . Trial Registration Australian New Zeal and Clinical Trials Registry Background Reaction time , coordination , and cognition performance typically diminish in older adults , which may lead to gait impairments , falls , and injuries . Regular strength – balance exercises are highly recommended to reduce this problem and to improve health , well-being , and independence in old age . However , many older people face a lack of motivation in addition to other strong barriers to exercise . We developed ActiveLifestyle , an information technology (IT)-based system for active and healthy aging aim ing at improving balance and strength . ActiveLifestyle is a training app that runs on a tablet and assists , monitors , and motivates older people to follow personalized training plans autonomously at home . Objective The objectives were to ( 1 ) investigate which IT-mediated motivation strategies increase adherence to physical exercise training plans in older people , ( 2 ) assess the impact of ActiveLifestyle on physical activity behavior change , and ( 3 ) demonstrate the effectiveness of the ActiveLifestyle training to improve gait speed . Methods A total of 44 older adults followed personalized , 12-week strength and balance training plans . All participants performed the exercises autonomously at home . Question naires were used to assess the technological familiarity and stage of behavior change , as well as the effectiveness of the motivation instruments adopted by ActiveLifestyle . Adherence to the exercise plan was evaluated using performance data collected by the app and through information given by the participants during the study . Pretests and posttests were performed to evaluate gait speed of the participants before and after the study . Results Participants were 75 years ( SD 6 ) , predominantly female ( 64 % ) , held a trade or professional diploma ( 54 % ) , and their past profession was in a sitting position ( 43 % ) . Of the 44 participants who enrolled , 33 ( 75 % ) completed the study . The app proved to assist and motivate independently living and healthy older adults to autonomously perform strength – balance exercises ( median 6 on a 7-point Likert scale ) . Social motivation strategies proved more effective than individual strategies to stimulate the participants to comply with the training plan , as well as to change their behavior permanently toward a more physically active lifestyle . The exercises were effective to improve preferred and fast gait speed . Conclusions ActiveLifestyle assisted and motivated independently living and healthy older people to autonomously perform strength – balance exercises over 12 weeks and had low dropout rates . The social motivation strategies were more effective to stimulate the participants to comply with the training plan and remain on the intervention . The adoption of assistive technology devices for physical intervention tends to motivate and retain older people exercising for longer periods of time Background Computer-based interventions have demonstrated consistent positive effects on various physical abilities in older adults . This study aims to compare two training groups that achieve similar amounts of strength and balance exercise where one group receives an intervention that includes additional dance video gaming . The aim is to investigate the different effects of the training programs on physical and psychological parameters in older adults . Methods Thirty-one participants ( mean age ± SD : 86.2 ± 4.6 years ) , residents of two Swiss hostels for the aged , were r and omly assigned to either the dance group ( n = 15 ) or the control group ( n = 16 ) . The dance group absolved a twelve-week cognitive-motor exercise program twice weekly that comprised progressive strength and balance training supplemented with additional dance video gaming . The control group performed only the strength and balance exercises during this period . Outcome measures were foot placement accuracy , gait performance under single and dual task conditions , and falls efficacy . Results After the intervention between-group comparison revealed significant differences for gait velocity ( U = 26 , P = .041 , r = .45 ) and for single support time ( U = 24 , P = .029 , r = .48 ) during the fast walking dual task condition in favor of the dance group . No significant between-group differences were observed either in the foot placement accuracy test or in falls efficacy . Conclusions There was a significant interaction in favor of the dance video game group for improvements in step time . Significant improved fast walking performance under dual task conditions ( velocity , double support time , step length ) was observed for the dance video game group only . These findings suggest that in older adults a cognitive-motor intervention may result in more improved gait under dual task conditions in comparison to a traditional strength and balance exercise program . Trial registration This trial has been registered under IS RCT N05350123 ( http://www.controlled-trials.com OBJECTIVE This study investigated the effect of playing Nintendo ( ® ) " Wii Fit ™ Plus " ( Nintendo of America , Inc. , Redmond , WA ) on body balance and physical activity of nursing home residents . SUBJECTS AND METHODS In a nonr and omized controlled trial within a nursing home , two intervention groups ( both n=8 ) were exposed to the same treatment and compared with a control group ( n=13 ) . Intervention Group 1 consisted of elderly individuals with regular Nintendo " Wii Fit " experience for at least 1 year . Elderly persons who were novices to the Nintendo " Wii Fit ( Plus ) " participated in intervention Group 2 . Control participants had no experience with the Nintendo " Wii Fit ( Plus ) " and did not participate in the Nintendo " Wii Fit Plus " sessions . Outcome measurements were taken at baseline and after the intervention , using the Berg Balance Scale and the LASA Physical Activity Question naire . Participants of both intervention groups played the Nintendo " Wii Fit Plus " for 10 minutes twice a week during 12 weeks . RESULTS Although balance improved for all three groups , there was no effect of playing " Wii Fit Plus " ( P=0.89 ) . On physical activity , the intervention did have a positive effect ( P=0.005 ) ; physical activity levels increased with a median of 54.3 ( interquartile range , 63.1 ) minutes/day for intervention Group 1 and a median of 60.7 ( interquartile range , 56.8 ) minutes/day for intervention Group 2 . CONCLUSIONS This study showed an effect of Nintendo " Wii Fit Plus " gaming on physical activity of nursing home residents , but not on their balance . The effect of physical activity should be consoli date d in a r and omized controlled trial in a broader population Abstract Background Falls and fall-related injuries are a serious public health issue . Exercise programs can effectively reduce fall risk in older people . The iStoppFalls project developed an Information and Communication Technology-based system to deliver an unsupervised exercise program in older people ’s homes . The primary aims of the iStoppFalls r and omized controlled trial were to assess the feasibility ( exercise adherence , acceptability and safety ) of the intervention program and its effectiveness on common fall risk factors . Methods A total of 153 community-dwelling people aged 65 + years took part in this international , multicentre , r and omized controlled trial . Intervention group participants conducted the exercise program for 16 weeks , with a recommended duration of 120 min/week for balance exergames and 60 min/week for strength exercises . All intervention and control participants received educational material including advice on a healthy lifestyle and fall prevention . Assessment s included physical and cognitive tests , and question naires for health , fear of falling , number of falls , quality of life and psychosocial outcomes . Results The median total exercise duration was 11.7 h ( IQR = 22.0 ) over the 16-week intervention period . There were no adverse events . Physiological fall risk ( Physiological Profile Assessment , PPA ) reduced significantly more in the intervention group compared to the control group ( F1,127 = 4.54 , p = 0.035 ) . There was a significant three-way interaction for fall risk assessed by the PPA between the high-adherence ( > 90 min/week ; n = 18 , 25.4 % ) , low-adherence ( < 90 min/week ; n = 53 , 74.6 % ) and control group ( F2,125 = 3.12 , n = 75 , p = 0.044 ) . Post hoc analysis revealed a significantly larger effect in favour of the high-adherence group compared to the control group for fall risk ( p = 0.031 ) , postural sway ( p = 0.046 ) , stepping reaction time ( p = 0.041 ) , executive functioning ( p = 0.044 ) , and quality of life ( p for trend = 0.052 ) . Conclusions The iStoppFalls exercise program reduced physiological fall risk in the study sample . Additional subgroup analyses revealed that intervention participants with better adherence also improved in postural sway , stepping reaction , and executive function . Trial registration Australian New Zeal and Clinical Trials Registry Trial ID : ACTRN12614000096651 International St and ard R and omised Controlled Trial Number : IS RCT Background This r and omized controlled pilot study aim ed to explore whether a cognitive-motor exercise program that combines traditional physical exercise with dance video gaming can improve the voluntary stepping responses of older adults under attention dem and ing dual task conditions . Methods Elderly subjects received twice weekly cognitive-motor exercise that included progressive strength and balance training supplemented by dance video gaming for 12 weeks ( intervention group ) . The control group received no specific intervention . Voluntary step execution under single and dual task conditions was recorded at baseline and post intervention ( Week 12 ) . Results After intervention between-group comparison revealed significant differences for initiation time of forward steps under dual task conditions ( U = 9 , P = 0.034 , r = 0.55 ) and backward steps under dual task conditions ( U = 10 , P = 0.045 , r = 0.52 ) in favor
Output:
| Adherence was higher for technology-based interventions than traditional interventions independent of study site , level of supervision , and delivery mode .
Discussion : This systematic review provides evidence that technology offers a well-accepted method to provide older adults with engaging exercise opportunities , and adherence rates remain high in both supervised and unsupervised setting s at least throughout the first 12 weeks of intervention .
The higher adherence rates to technology-based interventions can be largely explained by the high reported levels of enjoyment when using these programs .
However , the small sample sizes , short follow-up periods , inclusion of mostly healthy older people , and problems related to the methods used to report exercise adherence limit the generalizability of our findings .
Conclusion : This systematic review indicates that technology-based exercise interventions have good adherence and may provide a sustainable means of promoting physical activity and preventing falls in older people . |
MS212131 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
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***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: The purpose of this study was to compare the effect of an open-stance cycling protocol ( OSCP ) with the traditional cycling foot position ( TCFP ) for preferential vastus medialis oblique ( VMO ) muscle activation , measured by surface electromyography ( SEMG ) , and preferential VMO activation as defined by achieving significantly increased VMO/VL ( vastus lateralis muscle ) ratio values . Forty subjects of both sexes participated , 18 symptomatic with patellofemoral pain and 22 control subjects ; ages ranged from 18 to 60 years ( mean 5 28.7 ± 8 years ) . The OSCP and TCFP were ridden in r and omized order while SEMG recordings were taken of the VMO and VL muscles , collecting the mean of peak amplitudes to calculate VMO/VL ratio values . The SEMG readings were taken 4 times per testing session with r and omized resistance and a consistent cycling cadence of 85 rpm . The OSCP displayed preferential VMO activation for all subject groups ( F = 40.47 , p = 0.0001 ) , and this study revealed a protocol that effectively treats patellofemoral pain Strengthening of the vastus medialis oblique ( VMO ) has been advocated as a treatment for patellofemoral pain syndrome ( PFPS ) , as weakness of this component of the quadriceps is postulated to contribute to malalignment of the patella . This study investigated the surface electromyographic activity ( EMG ) of the VMO relative to the vastus lateralis ( VL ) during five isometric exercises in eight PFPS female subjects and 19 controls . The area under the EMG curve of each muscle was normalized to the EMG area acquired while subjects performed a submaximal isometric contraction ( 50 % of maximum voluntary contraction ) , and the " normalized " outcome measure was expressed as a proportion ( VMO : VL ) . A two-factor repeated measures analysis of variance indicated no differences in the VMO : VL proportion between the control group and PFPS participants across the five exercises ( p > .05 ) . The VMO : VL proportions for medial tibial rotation and knee extension combined and knee extension alone were significantly greater than for the other three exercises ( p < 0.005 ) . Hip adduction or the combination of hip adduction and knee extension did not result in greater recruitment of the VMO compared with the VL A prospect i ve study of 20 normal subjects was undertaken to determine the effect of three ankle positions ( active dorsiflexion , active plantar flexion , natural or rest position ) on comfort and facilitation of quadriceps contraction in isometric strengthening in a supine position with the hip and knee fully extended . Surface EMG activity was found to be greatest for the vastus lateralis followed by the vastus medialis and least for the rectus femoris . Equal facilitation was apparent with either active ankle dorsiflexion or plantar flexion . Both were superior to the natural ( rest ) position . In situations where isometric quadriceps exercises are required , the authors recommend either active ankle dorsiflexion or plantar flexion to facilitate quadriceps strengthening . The choice between the two positions should be based on patient comfort OBJECTIVE The purpose of this study was to investigate the effect of hip adduction on the activity of the Vastus Medialis Obliquus ( VMO ) and Vastus Lateralis Longus ( VLL ) muscles during semisquat exercises . METHODS Twenty female subjects , divided into two groups comprising healthy and patellofemoral pain syndrome ( PFPS ) subjects ( ten volunteers for each group ) , performed three double-leg semisquat exercise trials with maximum hip adduction isometric contraction ( DLSS-HA ) and three double-leg semisquat exercise trials without hip adduction ( DLSS ) . The normalized electromyographic muscle data were analysed using Repeated Measure ANOVA ( p < or=0.05 ) . RESULTS The electrical activity of both VMO and VLL muscles was significantly greater during DLSS-HA exercise than during DLSS ( p=0.0002 ) for both groups . Additionally , an independent Repeated Measure ANOVA revealed that the electric activity of the VLL muscle was significantly greater ( p=0.0149 ) than that of the VMO muscle during DLSS exercises only for the PFPS group . However , no differences were found during DLSS-HA exercises . CONCLUSIONS Although there was no preferential VMO muscle activation , the association of hip adduction with squat exercise promoted a greater balance between the medial and lateral portions of the quadriceps femoris muscle and could be indicated for the conservatory treatment of PFPS patients . The association of isometric hip adduction with isometric semisquat exercises produced a more overall quadriceps activity and could be indicated for clinical rehabilitation or muscle strengthening programs Lam PL , Ng GYF : Activation of the quadriceps muscle during semisquatting with different hip and knee positions in patients with anterior knee pain . Am J Phys Med Rehabil 2001;80:804–808 . Objective We measured the surface electromyographic activities of vastus medialis obliquus and vastus lateralis in 16 subjects with patellofemoral joint pain syndrome . Design Each subject performed bilateral static knee extension exercises at 60 % of his or her maximal voluntary effort under different combinations of hip rotation ( 30 degrees of medial rotation , neutral , 45 degrees of lateral rotation ) and knee flexion ( 20 and 40 degrees ) in a st and ing position . The ratio of surface-integrated electromyographic signals of vastus medialis obliquus over vastus lateralis was calculated for each of the six conditions . Because of significant interaction of hip rotation and knee flexion in the two-way analysis of variance , data were analyzed separately with paired t tests for the effect of knee positions and one-way repeated measures analysis of variance for hip positions . Results At 20 degrees of knee flexion , there was no significant difference among the three hip positions , whereas at 40 degrees of knee flexion , medial rotation of the hip result ed in significantly higher vastus medialis obliquus over vastus lateralis activity ratio than lateral rotation ( P < 0.05 ) . Conclusions There was relatively more activation of vastus medialis obliquus than vastus lateralis at 40 degrees of semisquat with the hip medially rotated by 30 degrees . This finding has clinical implication s for training the vastus medialis obliquus in patients with patellofemoral joint pain syndrome The purpose of this study was to determine whether various positions of the lower extremity affect the muscle activity of the vastus medialis obliquus ( VMO ) differently during both open and closed kinetic chain exercise conditions among patients with patellofemoral pain syndrome ( PFPS ) . Patients who presented with symptoms consistent with PFPS completed a series of open kinetic chain and closed kinetic chain exercises in which VMO activity was measured and compared . Statistical analysis revealed that there is less than a 0.001 % ( open kinetic chain ) or 0.005 % ( closed kinetic chain ) chance that all positions activate the VMO equally . In open kinetic exercise , maximum VMO activity was achieved with terminal knee extension with medial tibial rotation . During closed kinetic exercises , squats with external rotation were preferred for maximum VMO activation . Therefore , our results highlight the importance of including both the open and closed kinetic chain exercises into rehabilitation programs for patients with PFPS Nondriving intersegmental knee moment components ( i.e. , varus/valgus and internal/external axial moments ) are thought to be primarily responsible for the etiology of overuse knee injuries such as patellofermoral pain syndrome in cycling because of their relationship to muscular imbalances . However the relationship between these moments and muscle activity has not been studied . Thus the four primary objectives of this study were to test whether manipulating the inversion/eversion foot angle alters the varus/valgus knee moment ( Objective 1 ) and axial knee moment ( Objective 2 ) and to determine whether activation patterns of the vastus medialis oblique ( VMO ) , vastus lateralis ( VL ) , and tensor fascia latae ( TFL ) were affected by changes in the varus/valgus ( Objective 3 ) and axial knee moments ( Objective 4 ) . To fulfill these objectives , pedal loads and lower limb kinematic data were collected from 15 subjects who pedaled with five r and omly assigned inversion/eversion angles : 10 deg and 5 deg everted and inverted and 0 deg ( neutral ) . A previously described mathematical model was used to compute the nondriving intersegmental knee moments throughout the crank cycle . The excitations of the VMO , VL , and TFL muscles were measured with surface electromyography and the muscle activations were computed . On average , the 10-deg everted position decreased the peak varus moment by 55 % and decreased the peak internal axial moment by 53 % during the power stroke ( crank cycle region where the knee moment is extensor ) . A correlation analysis revealed that the VMO/VL activation ratio increased significantly and the TFL activation decreased significantly as the varus moment decreased . For both the VMO/VL activation ratio and the TFL activation , a path analysis indicated that the varus/valgus moment was highly correlated to the axial moment but that the correlation between muscle activation and the varus moment was due primarily to the varus/valgus knee moment rather than the axial knee moment . The conclusion from these results is that everting the foot may be beneficial towards either preventing or ameliorating patellofemoral pain syndrome in cycling PURPOSE To investigate the effect of physical therapy treatment on the timing of electromyographic ( EMG ) activity of the vasti in individuals with patellofemoral pain syndrome ( PFPS ) . METHODS Sixty-five ( 42 female , 23 male ) participants aged 40 yr or less ( 29.2 + /- 7.8 yr ) diagnosed with PFPS . Participants were r and omly allocated into physical therapy treatment ( McConnell-based ) or placebo groups . Treatment programs were st and ardized and consisted of six-treatment sessions over 6 wk . Vastus medialis oblique ( VMO ) and vastus lateralis ( VL ) EMG activity was recorded with surface electrodes during a stair-stepping task and onsets of EMG activity were measured pre- and post-treatment . RESULTS Before treatment , the EMG onset of VL occurred before that of VMO in both participant groups . After physical therapy intervention , there was a reduction in symptoms , and this improvement was associated with a significant change in the time of onset of VMO EMG compared with that of VL in both phases of the stair-stepping task . After physical therapy treatment , the onset of VMO preceded VL in the eccentric phase and occurred at the same time in the concentric phase of the stair-stepping task . There was no change in time of EMG onset in the placebo group . CONCLUSION This study demonstrates that a " McConnell"-based physical therapy treatment regime for PFPS alters the motor control of VMO relative to VL in a functional task and this is associated with a positive clinical outcome The clinical application of EMG requires that the recorded signal is representative of the muscle of interest and is not contaminated with signals from adjacent muscles . Some authors report that surface EMG is not suitable for obtaining information on a single muscle but rather reflects muscle group function [ J. Perry , C.S. Easterday , D.J. Antonelli , Surface versus intramuscular electrodes for electromyography of superficial and deep muscles . Physical Therapy 61 ( 1981 ) 7 - 15 ] . Other authors report however , that surface EMG is adequate to determine individual muscle function , once guidelines pertaining to data acquisition are followed [ D.A. Winter , A.J. Fuglev and , S.E. Archer . Cross-talk in surface electromyography : theoretical and practical estimates . Journal of Electromyography and Kinesiology 4 ( 1994 ) 15 - 26 ] . The aim of this study was to determine whether surface EMG was suitable for monitoring rectus femoris ( RF ) activity during static contractions . Five healthy subjects , having given written informed consent , participated in this trial . Surface and fine wire EMG from the rectus femoris and the vastus lateralis ( VL ) muscles were recorded simultaneously during a protocol of static contractions consisting of knee extensions and hip flexions . Ratios were used to quantify the relationship between the surface EMG amplitude value and the fine wire EMG amplitude value for the same contraction . The results showed that hip flexion contractions elicited RF activation only and that knee extension contractions elicited fine wire activity in VL only . When the relationship between RF surface and RF fine wire electrodes was compared for hip flexion and knee extension contractions , it was observed that for all subjects , there was a tendency for increased RF surface activity in the absence of RF fine wire activity during knee extensions . It was concluded that the activity recorded by the RF surface electrode arrangement during knee extension consisted of EMG from the vastii , i.e. , cross-talk and that vastus intermedius was the most likely origin of the erroneous signal . Therefore it is concluded that for accurate EMG information from RF , fine wire electrodes are necessary during a range of static contractions PURPOSE This study aim ed to examine whether a physical therapy intervention , design ed to reduce pain and improve the neuromotor control result ed in greater improvements in stance-phase knee flexion during stair ambulation in individuals with patellofemoral pain . The relationship between changes in stance-phase knee flexion and changes in pain , disability , and onset timing of individual vasti activity was also examined . METHODS Forty participants aged 40 yr or younger diagnosed with patellofemoral pain were r and omly allocated to a physical therapy ( N = 21 ) or placebo ( N = 19 ) treatment group . Stance-phase knee flexion was measured in two dimensions using a PEAK movement analysis system during stair ambulation . Individuals were divided into those with improvements in onset of vastus medialis obliquus ( V
Output:
| These reported principally that altering lower limb joint orientation or the addition of a co-contraction does not preferentially enhance VMO activity over VL . |
MS212132 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: BACKGROUND Persistent drug-resistant psychotic symptoms are a pervasive problem in the treatment of schizophrenia . AIMS To evaluate the durability of the treatment effects of cognitive-behavioural therapy for chronic schizophrenia one year after treatment termination . METHOD A comparison of clinical outcomes was made at one-year follow-up from a r and omised trial of cognitive-behavioural therapy , supportive counselling and routine care alone in the treatment of chronic schizophrenia . RESULTS Seventy out of the 72 patients ( 97 % ) who completed treatment were assessed at follow-up . There were significant differences between the three groups when positive and negative symptoms were analysed by means of ANCOVAs . Between-group comparisons indicated significant differences between cognitive-behavioural therapy and routine care at follow-up for positive symptoms . There was a trend towards significance for both cognitive-behavioural therapy and supportive counselling to be superior to routine care alone on negative symptoms . CONCLUSIONS At 12-month follow-up the significant advantage of cognitive-behavioural therapy compared to routine care alone remained BACKGROUND Comm and hallucinations are a distressing and high-risk group of symptoms that have long been recognised but little understood , with few effective treatments . In line with our recent research , we propose that the development of an effective cognitive therapy for comm and hallucinations ( CTCH ) would be enhanced by applying insights from social rank theory . AIMS We tested the efficacy of CTCH in reducing beliefs about the power of voices and thereby compliance , in a single-blind , r and omised controlled trial . METHOD A total of 38 patients with comm and hallucinations , with which they had recently complied with serious consequences , were allocated r and omly to CTCH or treatment as usual and followed up at 6 months and 12 months . RESULTS Large and significant reductions in compliance behaviour were obtained favouring the cognitive therapy group ( effect size 1.1 ) . Improvements were also observed in the CTCH but not the control group in degree of conviction in the power and superiority of the voices and the need to comply , and in levels of distress and depression . No change in voice topography ( frequency , loudness , content ) was observed . The differences were maintained at 12 months ' follow-up . CONCLUSIONS The results support the efficacy of cognitive therapy for CTCH Comm and hallucinations represent a special problem for the clinical management of psychosis . While compliance with both non-harmful and harmful comm and s can be problematic , sometimes in the extreme , active efforts to resist comm and s may also contribute to their malignancy . Previous research suggests Cognitive Behaviour Therapy ( CBT ) to be a useful treatment for reducing compliance with harmful comm and hallucinations . The purpose of this trial was to evaluate whether CBT augmented with acceptance-based strategies from Acceptance and Commitment Therapy could more broadly reduce the negative impact of comm and hallucinations . Forty-three participants with problematic comm and hallucinations were r and omized to receive 15 sessions of the intervention " TORCH " ( Treatment of Resistant Comm and Hallucinations ) or the control , Befriending , then followed up for 6 months . A sub- sample of 17 participants was r and omized to a waitlist control before being allocated to TORCH or Befriending . Participants engaged equally well with both treatments . Despite TORCH participants subjectively reporting greater improvement in comm and hallucinations compared to Befriending participants , the study found no significant group differences in primary and secondary outcome measures based on blinded assessment data . Within-group analyses and comparisons between the combined treatments and waitlist suggested , however , that both treatments were beneficial with a differential pattern of outcomes observed across the two conditions OBJECTIVE Patients with first-episode psychosis are responsive to acute-phase treatments , but relapse rates are high . This study aim ed to evaluate the effectiveness of a psychosocial treatment design ed to prevent the second episode of psychosis compared with st and ardized early psychosis care . METHOD In a r and omized controlled trial , conducted at the Early Psychosis Prevention and Intervention Centre and Barwon Health , Australia , a multimodal individual and family cognitive-behavioral therapy for relapse prevention was compared with st and ardized case management within a specialist early psychosis service . Patients aged 15 to 25 years with a first episode of a DSM-IV psychotic disorder were recruited between November 2003 and May 2005 . The main outcome measures were the number of relapses and time to first relapse . RESULTS Forty-one first-episode psychosis patients were r and omly assigned to the relapse prevention therapy ( RPT ) and 40 to st and ardized case management . At the 7-month follow up , the relapse rate was significantly lower in the therapy condition compared to treatment as usual ( p = .042 ) and time to relapse was significantly longer for the RPT condition ( p = .03 ) . The number needed to treat was 6 over 7 months . CONCLUSIONS Interim findings suggest that RPT provided within a specialist early psychosis program was effective in reducing relapse in early psychosis when compared with st and ardized early psychosis case management . TRIAL REGISTRATION www.anzctr.org.au Identifier : ACTRN12605000514606 BACKGROUND There is increasing evidence that cognitive-behavioural therapy can be an effective intervention for patients experiencing drug-refractory positive symptoms of schizophrenia . AIMS To investigate the effects of cognitive-behavioural therapy on in- patients with treatment-refractory psychotic symptoms . METHOD Manualised therapy was compared with supportive counselling in a r and omised controlled study . Both interventions were delivered by experienced psychologists over 16 sessions of treatment . Therapy fidelity was assessed by two independent raters . Participants underwent masked assessment at baseline , after treatment and at 6 months ' follow-up . Main outcome measures were the Positive and Negative Syndrome Scale and the Psychotic Symptoms Rating Scale . The analysis was by intention to treat . RESULTS Participants receiving cognitive cognitive-behavioural therapy had improved with regard to auditory hallucinations and illness insight at the post-treatment assessment , but these findings were not maintained at follow-up . CONCLUSIONS Cognitive-behavioural therapy showed modest short-term benefits over supportive counselling for treatment-refractory positive symptoms of schizophrenia BACKGROUND Family intervention reduces relapse rates in psychosis . Cognitive-behavioural therapy ( CBT ) improves positive symptoms but effects on relapse rates are not established . AIMS To test the effectiveness of CBT and family intervention in reducing relapse , and in improving symptoms and functioning in patients who had recently relapsed with non-affective psychosis . METHOD A multicentre r and omised controlled trial ( IS RCT N83557988 ) with two pathways : those without carers were allocated to treatment as usual or CBT plus treatment as usual , those with carers to treatment as usual , CBT plus treatment as usual or family intervention plus treatment as usual . The CBT and family intervention were focused on relapse prevention for 20 sessions over 9 months . RESULTS A total of 301 patients and 83 carers participated . Primary outcome data were available on 96 % of the total sample . The CBT and family intervention had no effects on rates of remission and relapse or on days in hospital at 12 or 24 months . For secondary outcomes , CBT showed a beneficial effect on depression at 24 months and there were no effects for family intervention . In people with carers , CBT significantly improved delusional distress and social functioning . Therapy did not change key psychological processes . CONCLUSIONS Generic CBT for psychosis is not indicated for routine relapse prevention in people recovering from a recent relapse of psychosis and should currently be reserved for those with distressing medication-unresponsive positive symptoms . Any CBT targeted at this acute population requires development . The lack of effect of family intervention on relapse may be attributable to the low overall relapse rate in those with carers UNLABELLED Cognitive behavioural therapy ( CBT ) is recommended in treatment guidelines for psychotic symptoms ( NICE , 2009 ) but clients from some minority groups have been shown to have higher dropout rates and poorer outcomes . A recent qualitative study in ethnic minority groups concluded that CBT would be acceptable and may be more effective if it was culturally adapted to meet their needs ( Rathod et al. , 2010 ) . AIM This study assessed the effectiveness of a culturally adapted CBT for psychosis ( CaCBTp ) in Black British , African Caribbean/Black African and South Asian Muslim participants . METHOD A r and omised controlled trial was conducted in two centres in the UK ( n=35 ) in participants with a diagnosis of a disorder from the schizophrenia group . Assessment s were conducted at three time points : baseline , post-therapy and at 6 months follow-up , using the Comprehensive Psychopathological Rating Scale ( CPRS ) and Insight Scale . Outcomes on specific subscales of CPRS were also evaluated . Participants in the treatment arm completed the Patient Experience Question naire ( PEQ ) to measure satisfaction with therapy . Assessors blind to r and omisation and treatment allocation conducted administration of outcome measures . In total , n=33 participants were r and omly allocated to CaCBTp arm ( n=16 ) and treatment as usual ( TAU ) arm ( n=17 ) after ( n=2 ) participants were excluded . CaCBTp participants were offered 16 sessions of CaCBTp with trained therapists and the TAU arm continued with their st and ard treatment . RESULTS Analysis was based on the principles of intention to treat ( ITT ) . This was further supplemented with secondary sensitivity analyses . Post-treatment , the intervention group showed statistically significant reductions in symptomatology on overall CPRS scores , CaCBTp Mean (SD)=16.23 ( 10.77 ) , TAU=18.60 ( 14.84 ) ; p=0.047,with a difference in change of 11.31 ( 95 % CI:0 . 14 to 22.49 ) ; Schizophrenia change : CaCBTp=3.46 ( 3.37 ) ; TAU=4.78 ( 5.33 ) diff 4.62 ( 95 % CI : 0.68 to 9.17 ) ; p=0.047 and positive symptoms ( delusions ; p=0.035 , and hallucinations ; p=0.056 ) . At 6 months follow-up , MADRAS change=5.6 ( 95 % CI : 2.92 to 7.60 ) ; p<0.001 . Adjustment was made for age , gender and antipsychotic medication . Overall satisfaction was significantly correlated with the number of sessions attended ( r=0.563 ; p=0.003 ) . CONCLUSION Participants in the CaCBTp group achieved statistically significant results post-treatment compared to those in the TAU group with some gains maintained at follow-up . High levels of satisfaction with the CaCBTp were reported Objective : The objective of this study was to investigate the efficacy of group-based cognitive-behavioural therapy ( CBT ) for social anxiety in schizophrenia . Method : Patients with schizophrenia ( 20 ) with comorbid social anxiety were r and omly assigned to the group-based CBT or wait-list control condition . Pre- , post- and 6-week follow-up ratings included measures of social anxiety and avoidance , mood and quality of life . Results : The intervention group improved on all outcome measures and the control group showed no change in symptomatology . Conclusions : Group-based CBT is effective in treating social anxiety in schizophrenia Background : Recent research indicates that cognitive-behaviour therapy ( CBT ) can be effective in ameliorating persistent positive symptoms in chronic psychotic patients . The effectiveness of CBT in acute and recent-onset psychosis has been little explored , although a recent pilot study indicated that CBT could significantly improve recovery in acutely psychotic in patients . Method : Short-term individual CBT was compared to supportive counselling/psychoeducation ( SC ) as an adjunct to st and ard inpatient hospital care and medication in 21 in patients experiencing a recent-onset acute schizophrenic episode . Results : Both groups showed significant reductions in Brief Psychiatric Rating Scale ( BPRS ) scores following treatment , although there were no group differences . Time to discharge did not differ significantly between the groups , although there was a greater variance for the SC patients . Two-year follow-up showed no significant differences between the groups , although the number of patients who relapsed , the number of relapses and the time to recurrence of psychotic symptoms was lower in the CBT group than the SC group . Interestingly , the time to readmission was shorter in the CBT group . Conclusions : CBT and SC are acceptable treatments for recent-onset acutely psychotic in patients . A larger r and omised controlled trial over multiple hospital sites is warranted Emerging models of cognitive-behavioral treatment ( CBT ) offer promising new intervention strategies in the psychotherapy of schizophrenia . These models , however , have not been integrated into community support programs and evaluated in comparison to st and ard community treatments . This study examined differences in outcomes of clients who received long-term day treatment program services ( DTP ) compared to clients who received individual CBT that was included as part of their DTP treatment . Twenty-four clients were r and omly assigned to DTP treatment or CBT/DTP treatment . Data on st and ardized measures of psychosocial functioning , symptomatology and rehospitalizations were collected over the course of three years of treatment . Analysis of variance with repeated measures was conducted to evaluate the effects of type of treatment ( CB
Output:
| Use of a control intervention did not moderate effect size in any of the analyses .
There was no consistent evidence of publication bias across different analyses .
Cognitive-behavioural therapy has a therapeutic effect on schizophrenic symptoms in the ' small ' range . |
MS212133 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Associations between modifiable exposures and disease seen in observational epidemiology are sometimes confounded and thus misleading , despite our best efforts to improve the design and analysis of studies . Mendelian r and omization-the r and om assortment of genes from parents to offspring that occurs during gamete formation and conception-provides one method for assessing the causal nature of some environmental exposures . The association between a disease and a polymorphism that mimics the biological link between a proposed exposure and disease is not generally susceptible to the reverse causation or confounding that may distort interpretations of conventional observational studies . Several examples where the phenotypic effects of polymorphisms are well documented provide encouraging evidence of the explanatory power of Mendelian r and omization and are described . The limitations of the approach include confounding by polymorphisms in linkage disequilibrium with the polymorphism under study , that polymorphisms may have several phenotypic effects associated with disease , the lack of suitable polymorphisms for study ing modifiable exposures of interest , and canalization-the buffering of the effects of genetic variation during development . Nevertheless , Mendelian r and omization provides new opportunities to test causality and demonstrates how investment in the human genome project may contribute to underst and ing and preventing the adverse effects on human health of modifiable exposures BACKGROUND Epidemiologic studies have shown alcohol consumption to be inversely as well as positively related to body weight and body fat . Metabolic studies have shown an increase in energy intake as well as compensation after alcohol consumption . OBJECTIVE Our objective was to assess the effects on energy intake of an apéritif compared with those of a water appetizer and 3 fruit juice appetizers . DESIGN Fifty-two men and women aged 20 - 45 y with a body mass index ( in kg/m2 ) between 20 and 32 were r and omly given 1 MJ ( 340 mL ) alcohol ( wine or beer ) , fat ( cream fruit juice ) , protein ( protein fruit juice ) , carbohydrate ( grape juice ) , or water , or no preload 30 min before an ad libitum lunch consumed from the universal eating monitor . RESULTS Energy intake ( 3.5+/-0.3 MJ compared with 2.7+/-0.2 MJ , P < 0.001 ) and eating rate were higher ( 44+/-3 g/min compared with 38+/-3 g/min , P < 0.01 ) , meal duration was longer ( 14 min compared with 12.0 min , P < 0.01 ) , satiation started to increase later ( 3.5 min compared with 1.5 min , P < 0.01 ) , and eating was prolonged after maximum satiation ( 2.5 min compared with 0.6 min , P < 0.01 ) after an apéritif than after a fat , protein , or carbohydrate appetizer , . Twenty-four-hour energy intake was higher on a day that an apéritif was consumed than after water or no preload . CONCLUSION Twenty-four-hour energy intake was elevated with a 1-MJ apéritif but not with a 1-MJ liquid carbohydrate , fat , or protein appetizer The vasodilation that follows acute alcohol intake is hard to conciliate with the high prevalence of hypertension detected in those persons who consume regular amounts of alcohol . In this experiment we examined early and late hemodynamic effects of acute administration of water and of 15 g , 30 g , and 60 g of alcohol in 40 normal men , aged 19 to 30 years , using 24-h ambulatory blood pressure monitoring ( ABPM ) . Mean systolic and diastolic blood pressures were each approximately 4 mm Hg lower during the period immediately after ingestion of 60 g ( v 0 g ) of ethanol , and were 7 and 4 mm Hg higher , respectively , at night . The day minus night differences displayed a dose-response curve both for systolic ( P < .001 ) and diastolic blood pressure ( P = .045 ) . Three subjects in the 60-g group had more than 50 % of nightly blood pressure loads in the hypertensive range against none in the remaining groups ( P < .01 ) . In conclusion , our findings suggest that acute alcohol intake elicits a biphasic hemodynamic response , causing , first , vasodilatation and , later , a pressor effect . The higher prevalence of hypertension in alcohol abusers seen in epidemiological surveys may be , in part , a result of measurements done in the period of transiently increased blood pressure during ethanol washout Objective —Nitrates are used widely in clinical practice . However , the mechanism underlying the bioactivation of nitrates to release NO remains unclear . Recent animal data suggest that mitochondrial aldehyde dehydrogenase ( ALDH2 ) plays a central role in nitrate bioactivation , but its role in humans is not known . We investigated the role of ALDH2 in the vascular effects of nitroglycerin ( NTG ) in humans in vivo . Methods and Results —Forearm blood flow ( FBF ) responses to intra-arterial infusions of NTG , sodium nitroprusside ( SNP ) , and verapamil were measured in 12 healthy volunteers before and after ALDH2 inhibition by disulfiram . All drugs caused a dose-dependent vasodilatation . However , only the response to NTG was significantly reduced after disulfiram therapy ( 33 % reduction in area under the curve [ AUC ] ; P=0.002 ) . Separately , 11 subjects of East Asian origin , with the loss-of-function glu504lys mutation in the ALDH2 gene , received intra-arterial NTG , SNP , and verapamil . Only the FBF response to NTG was lower in the volunteers with the glu504lys mutation compared with East Asian and non-Asian wild-type control subjects ( 40 % reduction in AUC ; P=0.02 ) . Conclusions —The findings suggest that ALDH2 is involved in the bioactivation of NTG in humans in vivo but accounts for less than half of the total bioactivation . This may be of clinical importance in patients with mutations in the ALDH2 gene and in those taking drugs that inhibit ALDH2 Abstract Deficiencies in mitochondrial low-Km aldehyde dehydrogenase ( ALDH2 ) activity , and consequently high blood acetaldehyde levels , have been suggested to relate to various diseases in Japanese , including esophageal cancer . In the present study , 200 men aged 35 - 59 years r and omly selected from an occupational population were analyzed for the association of ALDH2 genotypes and cytochrome P450 - 2E1 ( CYP2E1 ) genotypes with the urinary excretion of acetaldehyde ( which is bound to some chemicals in the urine ) and with common alcohol-related health consequences . Urinary acetaldehyde excretion was increased , reflecting increased alcohol consumption even in this moderate alcohol-consuming population . Neither the ALDH2 nor the CYP2E1 genotypes showed significant influence on the elevation of urinary acetaldehyde excretion . Neither these genotypes nor urinary acetaldehyde concentration significantly affected blood pressure , serum aspartate aminotransferase and gamma-glutamyl transferase activities , or serum HDL-cholesterol and lipid peroxide concentrations . It was concluded that acetaldehyde accumulates in moderate alcohol consumers irrespective of ALDH2 and CYP2E1 genotype , and that the implication s of these genotypes and acetaldehyde accumulation in terms of common alcohol-related health consequences were obscure . The results also suggest that the carcinogenicity of acetaldehyde on esophageal mucosa depends greatly upon repeated exposure to high blood acetaldehyde , even through transient rather than chronic exposure Among older people , the detection and control of hypertension is particularly important to reduce cardiovascular disease risk . This cross-sectional survey aim ed to describe the detection , treatment and control of hypertension in older British adults . A total of 3059 women and 3007 men aged 60–79 years were r and omly selected from general practice age/sex registers in 24 British towns and examined from 1998 to 2001 . Of these , 52.6 % women and 47.9 % men had at least one indicator of hypertension ( high blood pressure on examination , or taking antihypertensive medication or recalled a doctor diagnosis of high blood pressure ) . Among women , 50 % of those with any indication of hypertension were on treatment and 29 % were well controlled , and among men 45 % were on treatment and 16 % were well controlled . With the exception of alcohol use in men ( adjusted odds ratio 0.67 ( 0.46 , 0.98 ) ) , socioeconomic factors , area of residence and behavioural risk factors were not associated with good control among those with hypertension in either sex . Of those on treatment , 20.7 % of women and 28 % of men were on two classes of antihypertensive medication and 3.5 and 4.9 % , respectively , were on three or more classes of antihypertensive medication . Among those with a doctor diagnosis of hypertension and taking antihypertensive medication , the proportion with well controlled blood pressure did not differ between those on more than one antihypertensive and those on just one in either sex . We conclude that targets of good control are rarely met in older individuals , who would benefit from the associated reduction in cardiovascular disease risk OBJECTIVE Alcohol consumption may play a role in the development of obesity but the relationship between alcohol and weight is still unclear . The aim of our study was to assess the cross-sectional association of intakes of total alcohol and of specific alcoholic beverages ( wine , beer and spirits ) with waist-to-hip ratio ( WHR ) and body mass index ( BMI ) in a large sample of adults from all over France . DESIGN Cross-sectional . SETTING Participants were free-living healthy volunteers of the SU.VI.MAX study ( an intervention study on the effects of antioxidant supplementation on chronic diseases ) . SUBJECTS For 1481 women aged 35 - 60 years and 1210 men aged 45 - 60 years , intakes of total alcohol and specific alcoholic beverages were assessed by six 24-hour dietary records . BMI and WHR were measured during a clinical examination the year after . RESULTS A J-shaped relationship was found between total alcohol consumption and WHR in both sexes and between total alcohol consumption and BMI in men only ( P<0.05 ) . The same relationships were observed with wine ( P<0.05 ) ; men and women consuming less than 100 g day(-1 ) had a lower BMI ( men only ) and WHR than non-drinkers or those consuming more . Spirits consumption was positively associated with BMI ( linear regression coefficient beta=0.21 , 95 % confidence interval ( CI ) : 0.09 - 0.34 and beta=0.22 , 95 % CI : 0.06 - 0.39 for men and women , respectively ) and WHR ( beta=0.003 , 95 % CI : 0.001 - 0.005 and beta=0.003 , 95%CI : 0.0002 - 0.006 ) in both sexes in a linear fashion . No relationship between beer consumption and BMI or WHR was found . CONCLUSION If confirmed in longitudinal studies , our results indicate that consumption of alcoholic beverages may be a risk factor for obesity BACKGROUND Extract of globe artichoke ( Cynara scolymus ) is promoted as a possible preventive or cure for alcohol-induced hangover symptoms . However , few rigorous clinical trials have assessed the effects of artichoke extract , and none has examined the effects in relation to hangovers . We undertook this study to test whether artichoke extract is effective in preventing the signs and symptoms of alcohol-induced hangover . METHODS We recruited healthy adult volunteers between 18 and 65 years of age to participate in a r and omized double-blind crossover trial . Participants received either 3 capsules of commercially available st and ardized artichoke extract or indistinguishable , inert placebo capsules immediately before and after alcohol exposure . After a 1-week washout period the volunteers received the opposite treatment . Participants predefined the type and amount of alcoholic beverage that would give them a hangover and ate the same meal before commencing alcohol consumption on the 2 study days . The primary outcome measure was the difference in hangover severity scores between the artichoke extract and placebo interventions . Secondary outcome measures were differences between the interventions in scores using a mood profile question naire and cognitive performance tests administered 1 hour before and 10 hours after alcohol exposure . RESULTS Fifteen volunteers participated in the study . The mean number ( and st and ard deviation ) of alcohol units ( each unit being 7.9 g , or 10 mL , of ethanol ) consumed during treatment with artichoke extract and placebo was 10.7 ( 3.1 ) and 10.5 ( 2.4 ) respectively , equivalent to 1.2 ( 0.3 ) and 1.2 ( 0.2 ) g of alcohol per kilogram body weight . The volume of nonalcoholic drink consumed and the duration of sleep were similar during the artichoke extract and placebo interventions . None of the outcome measures differed significantly between interventions . Adverse events were rare and were mild and transient . INTERPRETATION Our results suggest that artichoke extract is not effective in preventing the signs and symptoms of alcohol-induced hangover . Larger studies are required to confirm these findings Blood pressure , heart rate and responses to a
Output:
| These findings support the hypothesis that alcohol intake has a marked effect on blood pressure and the risk of hypertension |
MS212134 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Background — Evidence on economically efficient strategies to lower blood pressure ( BP ) from low- and middle-income countries remains scarce . The Control of Blood Pressure and Risk Attenuation ( COBRA ) trial r and omized 1341 hypertensive subjects in 12 r and omly selected communities in Karachi , Pakistan , to 3 intervention programs : ( 1 ) combined home health education ( HHE ) plus trained general practitioner ( GP ) ; ( 2 ) HHE only ; and ( 3 ) trained GP only . The comparator was no intervention ( or usual care ) . The reduction in BP was most pronounced in the combined group . The present study examined the cost-effectiveness of these strategies . Methods and Results — Total costs were assessed at baseline and 2 years to estimate incremental cost-effectiveness ratios based on ( 1 ) intervention cost ; ( 2 ) cost of physician consultation , medications , diagnostics , changes in lifestyle , and productivity loss ; and ( 3 ) change in systolic BP . Precision of the incremental cost-effectiveness ratio estimates was assessed by 1000 bootstrapping replications . Bayesian probabilistic sensitivity analysis was also performed . The annual costs per participant associated with the combined HHE plus trained GP , HHE alone , and trained GP alone were $ 3.99 , $ 3.34 , and $ 0.65 , respectively . HHE plus trained GP was the most cost-effective intervention , with an incremental cost-effectiveness ratio of $ 23 ( 95 confidence interval , 6–99 ) per mm Hg reduction in systolic BP compared with usual care , and remained so in 97.7 of 1000 bootstrapped replications . Conclusions — The combined intervention of HHE plus trained GP is potentially affordable and more cost-effective for BP control than usual care or either strategy alone in some communities in Pakistan , and possibly other countries in Indochina with similar healthcare infrastructure . Clinical Trial Registration — http://www . clinical trials.gov . Unique identifier : NCT00327574 Objective : To estimate and compare the cost-effectiveness and safety of nebivolol with sustained-release metoprolol in reducing blood pressure by 1 mm of Hg per day in hypertensive patients . Material s and Methods : This was a prospect i ve , r and omized , open label , observational analysis of cost-effectiveness , in a question naire-based fashion to compare the cost of nebivolol ( 2.5 mg , 5 mg , 10 mg ) and sustained released metoprolol succinate ( 25 mg , 50 mg , 100 mg ) in hypertensive patients using either of the two drugs . A total of 60 newly detected drug naïve hypertensive patients were considered for the comparison , of which 30 patients were prescribed nebivolol and the other 30 were prescribed metoprolol succinate as per the recommended dosage . Based on the data , statistical analysis was carried out using GraphPad Prism 5 and MS Excel Spreadsheet 2007 . Result : The cost of reducing 1 mm of Hg blood pressure per day with nebivolol was 0.60 , 0.70 , and 1.06 INR , whereas that of metoprolol succinate was 0.93 , 1.18 , and 1.25 INR at their respective equivalent doses , hence significantly lower with the nebivolol group as compared to the metoprolol group ( P < 0.05 ) . Conclusion : This pharmacoeconomic analysis shows that nebivolol is more cost-effective as compared to metoprolol when the cost per reduction in blood pressure per day is considered . This may affect the patients economically during their long-term use of these molecules for the treatment of hypertension Introduction While a number of strategies are being implemented to control cardiovascular diseases ( CVDs ) and type 2 diabetes mellitus ( T2DM ) , the cost-effectiveness of these in the South Asian context has not been systematic ally evaluated . We aim to systematic ally review the economic ( cost-effectiveness ) evidence available on the individual- , group- and population -level interventions for control of CVD and T2DM in South Asia . Methods and analysis This review will consider all relevant economic evaluations , either conducted alongside r and omised controlled trials or based on decision modelling estimates . These studies must include participants at risk of developing CVD/T2DM or with established disease in one or more of the South Asian countries ( India , Bangladesh , Pakistan , Sri Lanka , Nepal , Maldives , Bhutan and Afghanistan ) . We will identify relevant papers by systematic ally search ing all major data bases and registries . Selected articles will be screened by two independent research ers . Method ological quality of the studies will be assessed using a modified Drummond and a Phillips checklist . Cochrane guidelines will be followed for bias assessment in the effectiveness studies . Results Results will be presented in line with the PRISMA ( Preferred Reporting Items for Systematic review and Meta- analysis ) checklist , and overall quality of evidence will be presented as per the GRADE ( Grade s of Recommendation , Assessment , Development and Evaluation ) approach . Ethics and dissemination The study has received ethics approval from the All India Institute of Medical Sciences , New Delhi , India . The results of this review will provide policy-relevant recommendations for the uptake of cost-effectiveness evidence in prioritising decisions on essential chronic disease care packages for South Asia . Study registration number PROSPERO CRD42013006479 Background Like a growing number of rapidly developing countries , India has begun to develop a system for large-scale community-based screening for diabetes . We sought to identify the implication s of using alternative screening instruments to detect people with undiagnosed type 2 diabetes among diverse population s across India . Methods and Findings We developed and vali date d a microsimulation model that incorporated data from 58 studies from across the country into a nationally representative sample of Indians aged 25–65 y old . We estimated the diagnostic and health system implication s of three major survey-based screening instruments and r and om glucometer-based screening . Of the 567 million Indians eligible for screening , depending on which of four screening approaches is utilized , between 158 and 306 million would be expected to screen as “ high risk ” for type 2 diabetes , and be referred for confirmatory testing . Between 26 million and 37 million of these people would be expected to meet international diagnostic criteria for diabetes , but between 126 million and 273 million would be “ false positives . ” The ratio of false positives to true positives varied from 3.9 ( when using r and om glucose screening ) to 8.2 ( when using a survey-based screening instrument ) in our model . The cost per case found would be expected to be from US$ 5.28 ( when using r and om glucose screening ) to US$ 17.06 ( when using a survey-based screening instrument ) , presenting a total cost of between US$ 169 and US$ 567 million . The major limitation of our analysis is its dependence on published cohort studies that are unlikely fully to capture the poorest and most rural areas of the country . Because these areas are thought to have the lowest diabetes prevalence , this may result in overestimation of the efficacy and health benefits of screening . Conclusions Large-scale community-based screening is anticipated to produce a large number of false-positive results , particularly if using currently available survey-based screening instruments . Re source allocators should consider the health system burden of screening and confirmatory testing when instituting large-scale community-based screening for diabetes Abstract Aims : The aim of this analysis was to assess the cost-effectiveness of switching from biphasic human insulin 30 ( BHI ) , insulin glargine ( IGlar ) , or neutral protamine Hagedorn ( NPH ) insulin ( all ± oral glucose-lowering drugs [ OGLDs ] ) to biphasic insulin aspart 30 ( BIAsp 30 ) in people with type 2 diabetes in India , Indonesia , and Saudi Arabia . Methods : The IMS CORE Diabetes Model was used to determine the clinical outcome , costs , and cost-effectiveness of switching from treatment with BHI , IGlar , or NPH to BIAsp 30 over a 30-year time horizon . A 1-year analysis was also performed based on quality -of-life data and treatment costs . Incremental cost-effectiveness ratios ( ICERs ) were expressed as a fraction of gross domestic product ( GDP ) per capita , and cost-effectiveness was defined as ICER < 3-times GDP per capita . Results : Switching treatment from BHI , IGlar , or NPH to BIAsp 30 was associated with an increase in life expectancy of > 0.7 years , reduction in all diabetes-related complications , and was considered as cost-effective or highly cost-effective in India , Indonesia , and Saudi Arabia ( BHI to BIAsp 30 , 0.26 in India , 1.25 in Indonesia , 0.01 in Saudi Arabia ; IGlar to BIAsp 30 , −0.68 in India , −0.21 in Saudi Arabia ; NPH to BIAsp 30 , 0.15 in India , −0.07 in Saudi Arabia ; GDP per head per annum/ quality -adjusted life-year ) . Cost-effectiveness was maintained in the 1-year analyses . Conclusions : Switching from treatment with BHI , IGlar , or NPH to BIAsp 30 ( all ± OGLDs ) was found to be cost-effective in India , Indonesia , and Saudi Arabia , both in the long and short term OBJECTIVE Intervention strategies are available for reducing the high global burden of hazardous alcohol use as a risk factor for disease , but little is known about their potential costs and effects at a population level . This study set out to estimate these costs and effects . METHOD Analyses were carried out for 12 epidemiological World Health Organization subregions of the world . A population model was used to estimate the impact of evidence -based personal and nonpersonal interventions --including brief physician advice , taxation , roadside r and om breath testing , restricted sales access and advertising bans . Costs were measured in international dollars ( I$ ) ; population -level intervention effects were gauged in terms of disability-adjusted life years ( DALYs ) averted . Average and incremental cost-effectiveness ratios ( CERs ) were computed . RESULTS The most costly interventions to implement are brief advice in primary care and roadside breath testing of drivers . In population s with a high prevalence of heavy drinkers ( more than 5 % , such as Europe and North America ) , the most effective and cost-effective intervention was taxation ( more than 500 DALYs averted per 1 million population ; CER < I$500 per DALY averted ) . In population s with a lower prevalence of heavy drinking , however , taxation is estimated to be less cost effective overall than other , more targeted strategies , such as brief physician advice , roadside breath testing and advertising bans . CONCLUSIONS The most efficient public health response to the burden of alcohol use depends on the prevalence of hazardous alcohol use , which is related to overall per capita consumption . Population -wide measures , such as taxation , are expected to represent the most cost-effective response in population s with moderate or high levels of drinking , whereas more targeted strategies are indicated in population s with lower rates of hazardous alcohol use OBJECTIVES Mathematical modeling is used widely in economic evaluations of pharmaceuticals and other health-care technologies . Users of models in government and the private sector need to be able to evaluate the quality of models according to scientific criteria of good practice . This report describes the consensus of a task force convened to provide modelers with guidelines for conducting and reporting modeling studies . METHODS The task force was appointed with the advice and consent of the Board of Directors of ISPOR . Members were experienced developers or users of models , worked in academia and industry , and came from several countries in North America and Europe . The task force met on three occasions , conducted frequent correspondence and exchanges of drafts by electronic mail , and solicited comments on three drafts from a core group of external review ers and more broadly from the membership of ISPOR . RESULTS Criteria for assessing the quality of models fell into three areas : model structure , data used as inputs to models , and model validation . Several major themes cut across these areas . Models and their results should be represented as aids to decision making , not as statements of scientific fact ; therefore , it is inappropriate to dem and that models be vali date d prospect ively before use . However , model assumptions regarding causal structure and parameter estimates should be continually assessed against data , and models should be revised accordingly . Structural assumptions and parameter estimates should be reported clearly and explicitly , and opportunities for users to appreciate the conditional relationship between inputs and outputs should be provided through sensitivity analyses . CONCLUSIONS Model-based evaluations are a valuable re source for health-care decision makers . It is the responsibility of model developers to conduct modeling studies according to the best practicable st and ards of quality and to communicate results with adequate disclosure of assumptions and with the caveat that conclusions are conditional upon the assumptions and data on which the model is built Background R and omized control trials from the developed world report that clinical decision support systems ( DSS ) could provide an effective means to improve the management of hypertension ( HTN ) . However , evidence from developing countries in this regard is rather limited , and there is a need to assess the impact of a clinical DSS on managing HTN in primary health care center ( PHC ) setting s. Methods and Results We performed a cluster r and omized trial to test the effectiveness and cost‐effectiveness of a clinical DSS among Indian adult hypertensive patients ( between 35 and 64 years of age ) , wherein 16 PHC clusters from a district of Telangana state , India , were r and omized to receive either a DSS or a chart‐based support ( CBS ) system . Each intervention arm had 8 PHC clusters , with a mean of 102 hypertensive patients per cluster ( n=845 in DSS and 783 in CBS groups
Output:
| The cost-effectiveness evidence for CVD and DM interventions in South Asia is growing , but most evidence is from India and limited to decision modelled outcomes . |
MS212135 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: OBJECTIVE To investigate food and nutrient intakes in 3-year-old children . SUBJECTS Eight hundred and sixty-three children resident in South West Engl and ( 69 % of those invited at this age ) , a r and omly selected sub- sample of the Avon Longitudinal Study of Pregnancy and Childhood ( ALSPAC ) . METHODS Diet was assessed using a 3-day descriptive food record . Food and nutrient intakes were compared with intakes at 18 months in the same children , with intakes in the British National Diet and Nutrition Survey ( NDNS ) of pre-school children , and with dietary reference values ( DRVs ) . RESULTS Intakes of energy and most nutrients had increased between 18 and 43 months . The macronutrient content of the diet had also changed , the percentage of energy from starch rose from 21 to 23 % and from non-milk extrinsic ( NME ) sugar from 12 to 16 % , while the polyunsaturated to saturated fat ratio increased from 0.26 to 0.33 . When compared with the NDNS , intakes of energy and all nutrients were higher with the exception of NME sugar . Energy intakes were below the estimated average requirements . Mean intakes of iron and vitamin D were below the Reference Nutrient Intake . Fewer children were eating beef at 43 months than at 18 months . Total daily meat consumption was lower than in the NDNS . The proportion of children consuming any vegetables dropped between 18 and 43 months , although fruit eating remained constant . CONCLUSIONS The diets of 3-year-olds in this study were adequate in most nutrients . Our results suggest that energy requirements of pre-school children in the 1990s are less than the DRV . Nutrient and food intakes changed between 18 and 43 months . Children were eating less meat than their counterparts in the NDNS OBJECTIVE To investigate the long-term effects of changes in dietary carbohydrate/fat ratio and simple vs complex carbohydrates . DESIGN R and omized controlled multicentre trial ( CARMEN ) , in which subjects were allocated for 6 months either to a seasonal control group ( no intervention ) or to one of three experimental groups : a control diet group ( dietary intervention typical of the average national intake ) ; a low-fat high simple carbohydrate group ; or a low-fat high complex carbohydrate group . SUBJECTS Three hundred and ninety eight moderately obese adults . MEASUREMENTS The change in body weight was the primary outcome ; changes in body composition and blood lipids were secondary outcomes . RESULTS Body weight loss in the low-fat high simple carbohydrate and low-fat high complex carbohydrate groups was 0.9 kg ( P < 0.05 ) and 1.8 kg ( P < 0.001 ) , while the control diet and seasonal control groups gained weight ( 0.8 and 0.1 kg , NS ) . Fat mass changed by -1.3 kg ( P < 0.01 ) , -1.8 kg ( P < 0.001 ) and + 0.6 kg ( NS ) in the low-fat high simple carbohydrate , low-fat high complex carbohydrate and control diet groups , respectively . Changes in blood lipids did not differ significantly between the dietary treatment groups . CONCLUSION Our findings suggest that reduction of fat intake results in a modest but significant reduction in body weight and body fatness . The concomitant increase in either simple or complex carbohydrates did not indicate significant differences in weight change . No adverse effects on blood lipids were observed . These findings underline the importance of this dietary change and its potential impact on the public health implication s of obesity Objective : To investigate whether subjects consuming a fat-reduced , high-simple carbohydrate diet ( SCHO ) are at greater risk of micronutrient inadequacy than subjects consuming a fat-reduced , high-complex carbohydrate ( CCHO ) or a normal-fat diet ( control , CD ) . Design : A 6-month r and omised controlled dietary intervention trial with a parallel design . Methods : In total , 46 overweight ( BMI : 24.4–36.3 kg/m2 ) subjects ( 19 males , 27 females ) aged 21–54 y consumed one of three ad libitum diets : SCHO , CCHO , or CD . Nutrient intake was assessed by a 7-day weighed food record . Results : Self-reported energy intake did not differ between diet groups . The lowest intake of vitamin B12 was found in the SCHO group vs CCHO ( P=0.025 ) and vs. CD ( P=0.012 ) . In men , zinc intake was lower on the SCHO diet compared to the CD diet ( P=0.018 ) . The recommendations for zinc and vitamin B12 were , however , met by all the diet groups . No other diet differences were observed . Intake of several micronutrients were insufficient in all three diet groups , although in most cases comparable to average Danish intakes . Conclusion : Zinc intake in men and vitamin B12 intake in the combined gender groups were lower on a fat-reduced , simple carbohydrate-rich diet compared to a habitual , normal-fat diet , but not below recommended levels . Sponsorship : The EU-FAIR program ( PL 95 - 809 ) , the Sugar Bureau , the European Sugar Industries , the Danish Medical Research Council , and the Danish Research and Development Programme for Food Technology BACKGROUND Nutritional intake by military personnel is typically inadequate during field exercises , potentially compromising health and performance . HYPOTHESIS Drinking a supplemental carbohydrate ( CHO ) beverage will increase total caloric intake and maintain nutritional status during military training in the desert . METHODS A total of 63 volunteers were r and omly assigned to one of two groups to receive either a CHO or placebo beverage with military rations during an 11-d desert field exercise . Fluid intake was ad libitum and adequate rations were provided . Blood sample s were collected twice to assess nutritional status , and nutrient intake was determined with consumption data . Mood state was examined by question naire . RESULTS Energy intake was significantly higher in the CHO group ( 3050 kcal x d(-1 ) vs. 2631 kcal x d(-1 ) ) , with additional CHO from the beverage providing energy with some compensation by reduced fat and protein intake . Intakes of energy , folacin , calcium , magnesium , iron , and zinc in both groups were inadequate , with intakes significantly lower ( p<0.05 ) for calcium , magnesium , and zinc in the CHO beverage group . Blood parameters of nutritional status remained within normal ranges with no differences between groups , but significant decreases were seen in pre-albumin . No changes in mood were seen during the training , nor after exposure to desert conditions . CONCLUSIONS The operational ration supplemented with a CHO beverage significantly increases CHO and energy intakes compared with st and ard rations and maintains nutritional status for short exercises . Fortification with micronutrients most at risk for deficient intake from foods may be needed for longer deployments OBJECTIVE To measure mineral intakes and the contribution of different food groups to mineral intakes in adults aged 18 - 64 years in Irel and . Intakes are reported for Ca , Mg , P , Fe , Cu and Zn . The adequacy of mineral intakes in the population and the risk of occurrence of excessive intakes are also assessed . DESIGN Food consumption was estimated using a 7-day food diary for a representative sample ( n=1379 ; 662 men , 717 women ) of 18 - 64-year-old adults in the Republic of Irel and and Northern Irel and selected r and omly from the electoral register . Mineral intakes ( Ca , Mg , P , Fe , Cu and Zn ) were estimated using tables of food composition . RESULTS Mean nutrient density of intakes was higher for women than men for Ca and Fe and increased with age for all minerals , except Ca for men and Fe for women . Meat and meat products were the major contributor to mean daily intakes of Zn ( 38 % ) , P ( 23 % ) , Fe ( 18 % ) , Cu ( 15 % ) and Mg ( 13 % ) ; dairy products ( milk , yoghurt and cheese ) to Ca ( 44 % ) , P ( 22 % ) , Zn ( 14 % ) and Mg ( 11 % ) ; bread and rolls to Fe ( 21 % ) , Cu ( 18 % ) , Ca and Mg ( 17 % ) , Zn ( 13 % ) and P ( 12 % ) ; potatoes and potato products to Cu ( 16 % ) , Mg ( 14 % ) and Fe ( 10 % ) ; and breakfast cereals to Fe ( 13 % ) . In women of all ages nutritional supplements contributed 7.6 % , 4.4 % , 3.6 % and 2.2 % of mean daily intake of Fe , Zn , Cu and Ca , respectively , while in men of all ages , nutritional supplements contributed 2.7 % , 2.3 % , 1.7 % and 0.6 % , respectively , to mean daily intakes of Fe , Zn , Cu and Ca . Adequacy of minerals intakes in population groups was assessed using the average requirement ( AR ) as a cut-off value . A significant prevalence of intakes below the AR was observed for Ca , Fe , Cu and Zn but not P. A higher proportion of women than men had intakes below the AR for all minerals . Almost 50 % of 18 - 50-year-old females had intakes below the AR for Fe , while 23 % , 23 % and 15 % of women of all ages had intakes below the AR for Ca , Cu and Zn , respectively . For men of all ages , 11 % , 8 % and 13 % had intakes below the AR for Ca , Cu and Zn , respectively . There appears to be little risk of excessive intake of Ca , Mg , P , Cu or Zn in any age/sex category . However , 2.9 % of women of all ages had intakes above the tolerable upper intake level for Fe ( 45 mg ) due to supplement use . CONCLUSION Almost 50 % of women aged 18 - 50 years had Fe intakes below the AR and relatively high proportions of women of all ages had intakes below the AR for Ca , Cu and Zn . With the possible exception of iron intake from supplements in women , there appears to be little risk of excessive intake of minerals in the adult population . Meat and meat products , dairy products ( milk , cheese and yoghurt ) , bread and rolls , potatoes and potato products and breakfast cereals are important sources of minerals ; nutritional supplements make only a small contribution to mineral intakes in the population as a whole but may contribute significantly to intakes among supplement users OBJECTIVES : To compare the response by overweight individuals , counselled in a work environment , to energy-reduced diets in which the amount of sucrose-containing foods is varied . DESIGN : Two energy-reduced diets were design ed as a weight-reducing programme . A low-sugar diet ( LSD ) providing 5 % of its energy from sucrose and a sugar-containing diet ( SCD ) providing 10 % of its energy from sucrose incorporated as sweet foods were devised . Both diets were constructed to contain about 33 % of the energy from fat . The diets , design ed to provide a deficit of 2.51 MJ/day ( 600 kcal/day ) per individual , were r and omly allocated to subjects in an 8 week parallel design study .SUBJECTS : Ninety-five subjects were recruited from a large service industry if they were more than 7 kg ( 1 stone ) in weight above body mass index ( BMI ) 25 kg/m2 . Sixty-eight subjects completed the programme . MEASUREMENTS : Fortnightly body weight measurements were taken using calibrated scales ; BMI at baseline and week 8 ; and nutrient intake using 2 day food record diaries at baseline and weeks 2 , 4 and 8 . RESULTS : Weight loss over the 8 weeks was 2.2 kg ( LSD ) and 3.0 kg ( SCD ) . BMI changed from 29.2 on the LSD and 30.1 kg/m2 SCD at baseline to 28.2 and 28.8 kg/m2 at week 8 respectively . The actual prescribed commercially added sucrose intakes were 5 % energy ( LSD ) or 10 % energy ( SCD ) . Reported percentage energy from fat was significantly lower on the SCD ( and would seem to support the theory of an inverse relationship between fat and sugar ) than on the LSD , where there was seen to be no significant reduction . There was no evidence of micronutrient dilution that could be directly attributed to the sucrose content of the diets . CONCLUSION : These results provide no justification for the exclusion of added sucrose in weight-reducing diets
Output:
| Curvilinear associations were found in some analyses , with lower nutrient intakes at both extremes of sugar intake ; however , factors such as dieting and under-reporting may confound the associations observed .
Mean intakes of most micronutrients were above the RDA or reference nutrient intake except among very high consumers of sugars .
The available evidence does not allow for firm conclusions on an optimal level of added sugars intake for micronutrient adequacy and the trends that exist may have little biological significance except for a few nutrients ( for example , Fe ) .
It is established that energy intake is the prime predictor of micronutrient adequacy . |
MS212136 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Objective To investigate the effects of Qingre Huoxue Decoction 清热活血方 , clearing heat and promoting blood flow ; QRHXD ) , on the radiographic progression in patients with rheumatoid arthritis ( RA ) by X-ray imaging . Methods Eighty-six patients with active RA diagnosed as damp-heat and blood stasis syndrome were r and omized into a QRHXD group and a QRHXD plus methotrexate ( MTX ) group , with 43 cases in each group . After one-year of treatment , 21 cases in each group ( 42 in total ) were evaluated . Radiographs of h and s were obtained at the baseline and after 12 months of treatment . Images were evaluated by investigators blinded to chronology and clinical data , and assessed according to the Sharp/Van der Heijde methods . Results High intrareader agreements were reached ( mean intraobserver intraclass coefficients : 0.95 ) . No significant change in any imaging parameters of joint destruction was observed at 12 months in either group ; and the differences between the two groups were not significant ( P>0.05 ) . The mean of the changing score in the QRHXD group was 3.5±4.1 , and 2.4±3.5 in the QRHXD+MTX group , while the baseline radiographic score of patients in the QRHXD group was relatively higher ( 18.9±19.1 vs. 14.0±14.0 ) . The mean rates of the changing scores of the two groups were similar ( 0.24±0.28 vs. 0.25±0.44 , P=0.40 ) . The severity of progression in the two groups was also similar ( P=0.46 ) , 7 cases without radiographic progression in the QRHXD group and 8 in the QRHXD+MTX group , 3 cases with obvious radiographic progression in the QRHXD group and 1 in the QRHXD+MTX group . Conclusion Radiographic progression of RA patients in both groups is similar , indicating that the QRHXD Decoction has a potential role in preventing bone destruction BACKGROUND SKI306X , which consists of biologically active ingredients from Clematis m and sburica , Tricbosantbes kirilowii , and Prunella vulgaris , was developed and tested in pre clinical trials in Korea . Those studies found that SKI306X was associated with an anti-inflammatory and analgesic effect , and that it can delay the destruction of cartilage in rheumatoid arthritis ( RA ) . OBJECTIVE The aim of this study was to compare the pain relief and tolerability of SKI306X and celecoxib in patients with RA . METHODS This study was a 6-week , multicenter , r and omized , double-blind , double-dummy , Phase III , noninferiority clinical trial . Eligible patients were aged 18 to 80 years , had a history of RA with a disease duration of > or =3 months , and were functional American College of Rheumatology ( ACR ) class I , II , or III before entry . After a washout period of 2 weeks , patients were r and omized to SKI306X 200 mg TID or celecoxib 200 mg BID for 6 weeks . The primary end point was a change in patient assessment of pain intensity using a visual analog scale ( VAS ) . The secondary end points were a 20 % improvement in response rate as defined by the ACR ( ACR20 ) and the frequency of rescue medication use . Results after 3 and 6 weeks of treatment were compared with baseline and between treatment groups , and all patients were assessed for adverse events ( AEs ) , clinical laboratory data , and vital signs . AEs were identified based on spontaneous reports by patients during interviews conducted by the investigators and the study coordinator . RESULTS Two hundred twenty-two Korean patients from 7 medical centers were assessed and 183 were enrolled and r and omized to 1 of 2 treatment groups . Ninety-one patients ( 10 male , 81 female ; mean [ SD ] age , 52.13 [ 12.64 ] years ; mean [ SD ] duration of RA , 9.08 [ 10.23 ] years ; no. [ % ] of ACR class I , II , and III , 13 [ 14.29 ] , 44 [ 48.35 ] and 34 [ 37.36 ] patients , respectively ) received SKI306X 200 mg TID and 92 patients ( 10 male , 82 female ; mean [ SD ] age , 51.78 [ 10.94 ] years ; mean [ SD ] duration of RA , 8.78 [ 7.78 ] years ; no. [ % ] of ACR class I , II , and III , 14 [ 15.22 ] , 44 [ 47.83 ] , and 34 [ 36.96 ] patients , respectively ) received celecoxib 200 mg BID . An analysis of the change in reported pain intensity as determined by VAS ( mm ) score between baseline and week 3 ( mean [ SD ] , 13.64 [ 16.62 ] vs 14.45 [ 15.89 ] ) , and between baseline and week 6 ( 18.4 [ 20.8 ] vs 17.9 [ 19.1 ] , respectively ) suggested that SKI306X was not inferior to celecoxib . The number of patients who achieved ACR20 response rate was not significantly different between the SKI306X group and the celecoxib group at week 3 ( 16/87 [ 18.4 % ] vs 24/87 [ 27.6 % ] , respectively ) and at week 6 ( 29/87 [ 33.3 % ] vs 29/87 [ 33.3 % ] ) . The frequency of rescue medication use was not significantly different between the SKI306X group and celecoxib group at week 3 ( 54/87 [ 62.1 % ] vs 47/87 [ 54.0 % ] , respectively ) or week 6 ( 57/87 [ 65.5 % ] vs 49/87 [ 56.3 % ] ) . Drug-related AEs were reported by 27 ( 29.7 % ) patients in the SKI306X group and 22 ( 23.9 % ) patients in the celecoxib group . The most frequent drug-related AEs were epigastric pain ( 9/91 [ 9.9 % ] ) in the SKI306X group and glutamyltranferase elevation ( 4/92 [ 4.3 % ] ) in the celecoxib group . No significant between-group differences were observed in the prevalence of drug-related clinical - or laboratory-determined AEs . CONCLUSION The results of this study suggest that SKI306X was generally well tolerated and not inferior to celecoxib in regard to pain relief in these Korean patients with RA Rheumatoid arthritis ( RA ) is the most common chronic inflammatory disease with unknown causes and unknown cures in Western medicine . This double-blinded study aim ed to investigate the efficacy and safety of a widely used traditional Chinese medicine ( Paeoniflorin ( PAE ) plus cervus and cucumis polypeptide injection ( CCPI ) using disease-modifying antirheumatic drugs ( DMARD ) as a control ( methotrexate ( MTX ) plus leflunomide ( LEF ) ) . Patients were r and omly assigned to one of the three groups : PAE + CCPI , MTX + LEF , and MTX + LEF + CCPI . The primary end point was the American College of Rheumatology 20 % improvement response criteria ( ACR20 ) . The secondary end point was that of adverse effect frequencies and the speed of onset action . Our results showed that more patients in the CCPI-containing groups responded to the ACR20 during early treatment . After six months , ACR20 showed no significant difference among the three treatments . The maximum improvement in the two DMARD groups was significantly higher than that in the PAE + CCPI group ( p < 0.01 ) . CCPI made the onset action of the DMARD therapy 4.6 times faster . PAE + CCPI had significantly lower adverse event incidences than the two DMARD groups . These results indicate that PAE + CCPI appear to be a more acceptable alternative to DMARDs when patients can not use DMARDs . CCPI appears to be a beneficial add-on to DMARDs that makes the onset of action faster , especially when patients need to relieve RA symptoms as soon as possible . Although not as effective as DMARDs , PAE appears to be a safer option to substitute DMARDs for long-term RA treatment when DMARD toxicity is an issue OBJECTIVE To observe the therapeutic effect of Yangxue Tongluo Recipe ( YTR ) combined with immunosuppressive agents in the treatment of rheumatoid arthritis ( RA ) . METHODS Totally 88 RA patients were r and omly assigned to the treatment group [ 47 cases , YTR combined Methotrexate ( MTX ) + Leflunomide ( LEF ) treatment ] and the control group ( 41 cases , MTX + LEF therapy ) . All patients received 12-week treatment . Clinical symptoms and signs , laboratory tests [ erythrocyte sedimentation rate ( ESR ) , rheumatoid factor ( RF ) , and C reactive protein ( CRP ) ] , and adverse reactions were observed before and after treatment . RESULTS The total effective rate was 91.5 % ( 43/47 cases ) in the treatment group , and the total effective rate was 75.6 % ( 31/41 cases ) in the control group . There was statistical difference between the two groups ( P < 0.05 ) . The morning stiffness , the rest pain , the number of tender joints , the number of swollen joints , tender joint index , swollen joint index , ESR , RF , and CRP were significantly improved in the two groups after treatment ( P < 0.01 ) . Besides , clinical symptoms and signs , ESR , RF , and CRP were more improved in the treatment group after treatment , when compared with those in the control group ( P < 0.05 ) . Gastrointestinal discomfort was the main adverse reaction in the two groups , but the occurrence was lower in the treatment group than in the control group ( P > 0.05 ) . CONCLUSIONS The clinical efficacy of YTR combined MTX + LEF in the treatment of RA was better than using Western medicine alone . It was more safe with less adverse reactions OBJECTIVE To observe the clinical efficacy and safety of Simiao Xiaobi Decoction ( SXD ) in treating active rheumatoid arthritis ( RA ) of humid pyretic toxic Bi-Zheng ( HPTB ) syndrome type . METHODS One hundred and twenty RA patients were r and omly assigned to 2 groups , 60 in the treatment group receiving SXD , and 60 in the control group receiving methotrexate , all were treated for 12 weeks . Clinical efficacy in patients was evaluated , referring to the criteria recommended by European League Against Rheumatoism ( EULAR ) , in terms of effective rate , main symptoms , signs , scoring on symptom/sign by Chinese medicine scale and DAS28 , physical and chemical indices , long-term outcome of patients and the average therapeutic effect initiating time . Meantime , the adverse reaction was recorded . RESULTS The study was completed in 103 patients , 52 in the treated group and 51 in the control group . According to a per- protocol analysis , the effective rate was better in the treatment group than in the control group with marked difference in terms of Chinese and Western medicine respectively ( 92.3 % vs 70.6 % and 86.5 % vs 62.7 % , P<0.05 ) . Superiorities in the treatment group were also seen in the improvements of main symptoms and signs , symptom/sign scores , DAS28 scores , and long-term outcome . Moreover , the average therapeutic effect initiating time was shorter ( 5.31 + /- 0.36 weeks vs 8.28 + /- 0.45 weeks ) , while the incidence of adverse reaction was less in the treatment group than in the control group ( 6.7 % vs 43.3 % , P<0.05 ) . CONCLUSION SXD can improve the joint symptoms and general condition of RA patients of HPTB type with shorter initiating time and less adverse reaction OBJECTIVE To examine the efficacy of popular Chinese herbs used in a traditional Chinese medicine ( TCM ) combination of Ganoderma lucidum and San Miao San ( SMS ) , with purported diverse health benefits including antioxidant properties in rheumatoid arthritis ( RA ) . METHODS We r and omly assigned 32 patients with active RA , despite disease-modifying antirheumatic drugs , to TCM and 33 to placebo in addition to their current medications for 24 weeks . The TCM group received G lucidum ( 4 gm ) and SMS ( 2.4 gm ) daily . The primary outcome was the number of patients achieving American College of Rheumatology ( ACR ) 20 % response and secondary outcomes included changes in the ACR components , plasma levels , and ex vivo-induced cytokines and chemokines and oxidative stress markers . RESULTS Eighty-nine percent completed the 24-week study . Fifteen percent in the TCM group compared with 9.1 % in the placebo group achieved ACR20 ( P > 0.05 ) . Pain score and patient 's global score improved significantly only in the TCM group . The percentage , absolute counts , and CD4+/CD8+/natural killer/B lymphocytes ratio
Output:
| In multivariable analysis , fewer authors were associated with selection bias ( allocation concealment ) , performance bias and attrition bias , and earlier year of publication and funding source not reported or disclosed were associated with selection bias ( sequence generation ) .
Studies published in non-English language were associated with reporting bias .
Studies evaluating CHM often fail to meet expected method ological criteria , and high- quality evidence is lacking |
MS212137 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: OBJECTIVE To examine whether a worksite nutrition programme using a low-fat vegan diet could significantly improve nutritional intake . DESIGN At two corporate sites of the Government Employees Insurance Company , employees who were either overweight ( BMI > or = 25 kg/m2 ) and /or had type 2 diabetes participated in a 22-week worksite-based dietary intervention study . SETTING At the intervention site , participants were asked to follow a low-fat vegan diet and participate in weekly group meetings that included instruction and group support ( intervention group ) . At the control site , participants received no instruction ( control group ) . At weeks 0 and 22 , participants completed 3 d dietary records to assess energy and nutrient intake . SUBJECTS A total of 109 participants ( sixty-five intervention and forty-four control ) . RESULTS In the intervention group , reported intake of total fat , trans fat , saturated fat and cholesterol decreased significantly ( P < or = 0.001 ) , as did energy and protein ( P = 0.01 ) , and vitamin B12 ( P = 0.002 ) , compared with the control group . Intake ( exclusive of any use of nutritional supplements ) of carbohydrate , fibre , vitamin C , magnesium and potassium increased significantly ( P < or = 0.0001 ) , as did that for beta-carotene ( P = 0.0004 ) , total vitamin A activity ( P = 0.004 ) , vitamin K ( P = 0.01 ) and sodium ( P = 0.04 ) in the intervention group , compared with the control group . CONCLUSIONS The present study suggests that a worksite vegan nutrition programme increases intakes of protective nutrients , such as fibre , folate and vitamin C , and decreases intakes of total fat , saturated fat and cholesterol BACKGROUND The beneficial effects of potassium-enriched salt on blood pressure have been reported in a few short-term trials . The long-term effects of potassium-enriched salt on cardiovascular mortality have not been carefully studied . OBJECTIVE The objective was to examine the effects of potassium-enriched salt on cardiovascular disease ( CVD ) mortality and medical expenditures in elderly veterans . DESIGN Five kitchens of a veteran retirement home were r and omized into 2 groups ( experimental or control ) and veterans assigned to those kitchens were given either potassium-enriched salt ( experimental group ) or regular salt ( control group ) for approximately 31 mo . Information on death , health insurance cl aims , and date s that veterans moved in or out of the home was gathered . RESULTS Altogether , 1981 veterans , 768 in the experimental [ x ( + /-SD ) age : 74.8 + /- 7.1 y ] and 1213 in the control ( age : 74.9 + /- 6.7 y ) groups , were included in the analysis . The experimental group had better CVD survivorship than did the control group . The incidence of CVD-related deaths was 13.1 per 1000 persons ( 27 deaths in 2057 person-years ) and 20.5 per 1000 ( 66 deaths in 3218 person-years ) for the experimental and control groups , respectively . A significant reduction in CVD mortality ( age-adjusted hazard ratio : 0.59 ; 95 % CI : 0.37 , 0.95 ) was observed in the experimental group . Persons in the experimental group lived 0.3 - 0.90 y longer and spent significantly less ( approximately US Dollars 426/y ) in inpatient care for CVD than did the control group , after control for age and previous hospitalization expenditures . CONCLUSIONS This study showed a long-term beneficial effect on CVD mortality and medical expenditure associated with a switch from regular salt to potassium-enriched salt in a group of elderly veterans . The effect was likely due to a major increase in potassium and a moderate reduction in sodium intakes BACKGROUND Sodium intake is high in people with type 2 diabetes ( T2DM ) . The aim of this study was to investigate whether urinary sodium excretion can be reduced by educating people with T2DM to read food labels and choose low sodium products . METHOD In a 3 month r and omised controlled trial , 78 men ( n=49 ) and women ( n=29 ) with T2DM were recruited from a Diabetes Centre at a University teaching hospital . The intervention group was educated in a single session to use the nutrition information panel on food labels to choose products which complied with the Food St and ards Australia New Zeal and ( FSANZ ) guideline of < 120 mg sodium/100 g food . The control group continued on their usual diet . The primary outcome measure was 24h urinary sodium excretion which was performed at baseline and 3 months . Data was analysed using repeated measures analysis of variance , independent sample s t-test and Pearson 's correlations . RESULTS At 3 months mean urinary sodium excretion was unchanged in the intervention ( 174±13 mmol/24 h and 175±13 mmol/24 h ) and control group ( 167±15mmol/24h and 161±13 mmol/24 h ) , and there was no between group difference ( p>0.05 ) . CONCLUSION Sodium excretion was not reduced following the label reading education provided to this group of people with T2DM The aim of this study is to examine sodium intake and dietary sodium sources of 1‐5‐y‐old children in a prospect i ve , r and omized long‐term coronary heart disease prevention trial , focused on dietary fat modification . Counselling included no advice about reducing salt in the children 's diets . Food consumption of 100 intervention children and 100 control children was recorded for 3 consecutive days at the age of 13 mo and for 4 consecutive days at the ages of 3 and 5 y. Sodium intakes were calculated using the Micro Nutrica program . Children 's mean daily sodium ( NaCl ) consumption ( intervention and control children combined ) was 1600 ± 527 mg ( 4.0 ± 1.3 g ) , 1900 ± 504 mg ( 4.8 ± 1.3 g ) and 2200 ± 531 mg ( 5.5 ± 1.3 g ) at the ages of 13 mo and 3 and 5 y , respectively . The intervention children consumed as much or slightly more sodium than the control children at all ages studied . Half the sodium consumption was derived from added salt in commercially prepared or homemade foods . Milk , meat products , bread and cereals were other important sodium sources Objectives To assess geographic and socioeconomic gradients in sodium and potassium intake in Italy . Setting Cross-sectional survey in Italy . Participants 3857 men and women , aged 39–79 years , r and omly sample d in 20 regions ( as part of a National cardiovascular survey of 8714 men and women ) . Primary outcome measures Participants ’ dietary sodium and potassium intakes were measured by 24 h urinary sodium and potassium excretions . 2 indicators measured socioeconomic status : education and occupation . Bayesian geoadditive models were used to assess spatial and socioeconomic patterns of sodium and potassium intakes accounting for sociodemographic , anthropometric and behavioural confounders . Results There was a significant north-south pattern of sodium excretion in Italy . Participants living in southern Italy ( eg , Calabria , Basilicata and Puglia > 180 mmol/24 h ) had a significantly higher sodium excretion than elsewhere ( eg , Val d'Aosta and Trentino-Alto Adige < 140 mmol/24 h ; p<0.001 ) . There was a linear association between occupation and sodium excretion ( p<0.001 ) . When compared with occupation I ( top managerial ) , occupations III and IV had a 6.5 % higher sodium excretion ( coefficients : 0.054 ( 90 % credible levels 0.014 , 0.093 ) and 0.064 ( 0.024 , 0.104 ) , respectively ) . A similar relationship was found between educational attainment and sodium excretion ( p<0.0001 ) . When compared with those with a university degree , participants with primary and junior school education had a 5.9 % higher urinary sodium ( coefficients : 0.074 ( 0.031 , 0.116 ) and 0.038 ( 0.001 , 0.075 ) , respectively ) . The socioeconomic gradient explained the spatial variation . Potassium excretion was higher in central regions and in some southern regions . Those in occupation V ( low-skill workers ) showed a 3 % lower potassium excretion compared with those in occupation I. However , the socioeconomic gradient only partially explained the spatial variation . Conclusions Salt intake in Italy is significantly higher in less advantaged social groups . This gradient is independent of confounders and explains the geographical variation Background In Africa hypertension is common and stroke is increasing . Detection , treatment and control of high blood pressure ( BP ) is limited . BP can be lowered by reducing salt intake . In Africa salt is added to the food by the consumer , as processed food is rare . A population -wide approach with programmes based on health education and promotion is thus possible . Methods We carried out a community-based cluster r and omised trial of health promotion in 1,013 participants from 12 villages ( 628 women , 481 rural dwellers ) ; mean age 55 years to reduce salt intake and BP . Average BP was 125/74 mmHg and urinary sodium ( UNa ) 101 mmol/day . A health promotion intervention was provided over 6 months to all villages . Assessment s were made at 3 and 6 months . Primary end-points were urinary sodium excretion and BP levels . Results There was a significant positive relationship between salt intake and both systolic ( 2.17 mmHg [ 95 % CI 0.44 to 3.91 ] per 50 mmol of UNa per day , p < 0.001 ) and diastolic BP ( 1.10 mmHg [ 0.08 to 1.94 ] , p < 0.001 ) at baseline . At six months the intervention group showed a reduction in systolic ( 2.54 mmHg [ -1.45 to 6.54 ] ) and diastolic ( 3.95 mmHg [ 0.78 to 7.11 ] , p = 0.015 ) BP when compared to control . There was no significant change in UNa . Smaller villages showed greater reductions in UNa than larger villages ( p = 0.042 ) . Irrespective of r and omisation , there was a consistent and significant relationship between change in UNa and change in systolic BP , when adjusted for confounders . A difference in 24-hour UNa of 50 mmol was associated with a lower systolic BP of 2.12 mmHg ( 1.03 to 3.21 ) at 3 months and 1.34 mmHg ( 0.08 to 2.60 ) at 6 months ( both p < 0.001 ) . Conclusion In West Africa the lower the salt intake , the lower the BP . It would appear that a reduction in the average salt intake in the whole community may lead to a small but significant reduction in population systolic BP Objectives To determine the relationship between the reduction in salt intake that occurred in Engl and , and blood pressure ( BP ) , as well as mortality from stroke and ischaemic heart disease ( IHD ) . Design Analysis of the data from the Health Survey for Engl and . Setting and participants Engl and , 2003 N=9183 , 2006 N=8762 , 2008 N=8974 and 2011 N=4753 , aged ≥16 years . Outcomes BP , stroke and IHD mortality . Results From 2003 to 2011 , there was a decrease in mortality from stroke by 42 % ( p<0.001 ) and IHD by 40 % ( p<0.001 ) . In parallel , there was a fall in BP of 3.0±0.33/1.4±0.20 mm Hg ( p<0.001/p<0.001 ) , a decrease of 0.4±0.02 mmol/L ( p<0.001 ) in cholesterol , a reduction in smoking prevalence from 19 % to 14 % ( p<0.001 ) , an increase in fruit and vegetable consumption ( 0.2±0.05 portion/day , p<0.001 ) and an increase in body mass index ( BMI ; 0.5±0.09 kg/m2 , p<0.001 ) . Salt intake , as measured by 24 h urinary sodium , decreased by 1.4 g/day ( p<0.01 ) . It is likely that all of these factors ( with the exception of BMI ) , along with improvements in the treatments of BP , cholesterol and cardiovascular disease , contributed to the falls in stroke and IHD mortality . In individuals who were not on antihypertensive medication , there was a fall in BP of 2.7±0.34/1.1±0.23 mm Hg ( p<0.001/p<0.001 ) after adjusting for age , sex , ethnic group , education , household income , alcohol consumption , fruit
Output:
| Multi-component strategies involving both upstream and downstream interventions , generally achieved the biggest reductions in salt consumption across an entire population , most notably 4g/day in Finl and and Japan , 3g/day in Turkey and 1.3g/day recently in the UK .
Worksite interventions achieved an increase in intake ( + 0.5g/day ) , however , with a very wide range .
Comprehensive strategies involving multiple components ( reformulation , food labelling and media campaigns ) and " upstream " population -wide policies such as m and atory reformulation generally appear to achieve larger reductions in population -wide salt consumption than " downstream " , individually focussed interventions . |
MS212138 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Since carnitine deficiency has been reported in some patients undergoing maintenance hemodialysis , we studied the effects of intravenous infusion of L-carnitine or placebo at the end of each dialysis treatment . The trial , which lasted seven months ( one month baseline , 6 months treatment ) was multicenter , double blind , placebo controlled , and r and omized . Eighty-two long-term hemodialysis patients , who were given either carnitine ( N = 38 ) or placebo ( N = 44 ) , completed this study . In each group , clinical and biochemical parameters during treatment were compared with baseline values . Intra-dialytic hypotension and muscle cramps were reduced only in the carnitine treated group , while improvement in post-dialysis asthenia was noticed in both carnitine and placebo groups . Maximal oxygen consumption , measured during a progressive work exercise test , improved significantly in the carnitine group ( 111 + /- 50 ml/min . P less than 0.03 ) and was unchanged in the placebo group . L-carnitine treatment was associated with a significant drop in pre-dialysis concentrations of serum urea nitrogen , creatinine and phosphorus ( means + /- SEM , 101 + /- 4.5 to 84 + /- 3.9 , 16.7 + /- 0.67 to 14.7 + /- 0.64 , and 6.4 + /- 0.3 to 5.5 + /- 0.4 mg/dl , respectively , P less than 0.004 ) . No significant changes in any of these variables were noticed in the placebo group . Mid-arm circumference and triceps skinfold thickness were measured in 11 carnitine and 13 placebo treated patients . Calculated mid-arm muscle area increased in the carnitine patients ( 41.37 + /- 2.68 to 45.6 + /- 2.82 cm2 , P = 0.05 ) and remained unchanged in the placebo patients . ( ABSTRACT TRUNCATED AT 250 WORDS It has been reported that treatment with L-carnitine at a daily dose of 3 g orally may cause a rise in platelet aggregation and serum triglyceride concentration in hemodialyzed patients . The present double-blind cross-over study has been performed to evaluate the influence of L-carnitine when compared with placebo on platelet aggregation and plasma concentrations of various factors involved in platelet activation . In addition , the concentration of triglycerides , cholesterol and HDL-cholesterol has been evaluated . 18 uremic patients on maintenance hemodialysis for at least 1 year were r and omly allocated either to a control group receiving placebo or to a group treated with L-carnitine . Statistical analysis performed by means of ANOVA did not show any significant change in the serum concentration of cholesterol , HDL-cholesterol and triglycerides . Furthermore , platelet aggregation tests ( performed with adenosine 5'-diphosphate , epinephrine , thrombin and collagen ) and plasma beta-thromboglobulin concentration did not show any statistically significant difference . In addition , the plasma concentration of several coagulation markers , such as factor VIIIc , antithrombin III , alpha 2-antiplasmin , and fibrinopeptide A , did not show any significant variation . The results suggest that under our experimental conditions L-carnitine neither increases the risk of thromboembolism nor alters the serum lipid content in uremic patients on chronic hemodialysis Hypertriglyceridemia is often present in chronically uremic patients treated with maintenance hemodialysis and has been considered a risk factor in the accelerated development of atheroma . Muscle carnitine content is low in hemodialyzed patients . This abnormality may help to explain the myopathy and cardiomyopathy often observed in these subjects . In addition , carnitine might play a role in the hypertriglyceridemia in renal failure . Carnitine , which is necessary for fatty acid oxidation , has been recently reported to lower serum triglycerides in patients with type IV hyperlipoproteinemia . Carnitine was administered intravenously three times weekly at the end of hemodialysis in eight patients . Carnitine was given in 0.5 g doses for 8 weeks and then in 1.0 g doses for 6 additional weeks . There was a significant decrease in serum triglycerides at the end of treatment . In contrast , serum lipids in eight hemodialysis patients receiving placebo did not change significantly . Carnitine administration does not cause any side effect except some euphoria . These results suggest that carnitine may be effective in the treatment of hypertriglyceridemia in dialysis patients A group of 14 uremic patients on intermittent hemodialysis was admitted to a cross-over double-blind trial in order to evaluate serum and muscle carnitine levels before and after 60 days of L-carnitine oral ( 2 g/day ) treatment . The morphology of muscle fragments was studied by light and electron microscopy . Symptoms ( asthenia , cramps ) occurring during hemodialysis were also recorded . After L-carnitine treatment the blood and muscle levels of the metabolite increased simultaneously to reduced asthenia and cramps . Morphological examination of the muscle of 13 of 14 patients did not reveal any pre- or posttreatment pathological alterations . The presence of nemaline rods was morphologically diagnosed in only one case and was no longer observed at the second biopsy at 2 months of L-carnitine treatment Left ventricular function was non-invasively studied in 28 r and omly selected haemodialysis patients before and after administration of L-carnitine , 2 g i.v . three times per week or saline in a double blind design ed study over a six-week period . Cardiac function variables showed no relationship to muscle ( vastus lateralis ) and plasma carnitine concentrations . No apparent deficiency in muscle carnitine was found , whereas total plasma carnitine was lower in female patients than in female controls , p less than 0.002 . The echocardiographic left ventricular end-diastolic diameter was initially increased in about one third and the ejection fraction was depressed in about one fifth of the patients . An increased A : H ratio was found in 15 % . Systolic time intervals were deranged in 30 % of the patients . After carnitine administration , marked increases of muscle and plasma carnitine levels were found , p less than 0.01 , but no effects were recorded in any of the cardiac tests . Muscle carnitine increased from 14.6 mmol/kg dry weight to a median of 23.7 mmol/kg . We found no support for the hypothesis that carnitine depletion is responsible for cardiac dysfunction in haemodialysis patients Previous studies have reported conflicting results of carnitine supplementation on plasma lipids in patients with chronic renal failure . We therefore performed a four center , double-blind placebo controlled trial to evaluate the effects of post-hemodialysis intravenous injection of L-carnitine in ESRD patients on maintenance hemodialysis . Thirty-eight patients received up to six months of L-carnitine infusions ( 20 mg/kg ) post-dialysis and 44 patients received placebo infusions . In both groups of patients , baseline pre-dialysis plasma and red blood cell total carnitine levels were normal , but pre-dialysis plasma-free carnitine concentrations and free/total ratios were subnormal , and plasma acyl levels were elevated . Post-dialysis plasma free and total carnitine concentrations were also subnormal . Plasma and red blood cell total carnitine levels rose eightfold in carnitine recipients , but were unchanged from baseline in those receiving placebo . There were no significant changes observed in plasma triglycerides , HDL-cholesterol or other lipoprotein parameters in either the carnitine or placebo treated groups . We conclude that carnitine metabolism is altered in uremia . Furthermore , in a r and omly-selected hemodialysis population , L-carnitine injection at the dose of 20 mg/kg results in significant increases in blood ( and perhaps tissue ) carnitine levels , but this is not associated with any major effects on lipid profiles End-stage renal disease affects every aspect of a patient 's life , including perception of health and quality of life . It is likely that a hemodialysis patient 's perceptions of health-related quality of life directly influence compliance with medical , nursing , and nutritional prescriptions . Because L-carnitine supplementation is known to enhance muscle strength and energy in hemodialysis patients , we hypothesized that L-carnitine supplementation would enhance a hemodialysis patient 's perception of health-related quality of life . To test this hypothesis , 1 g L-carnitine or placebo was administered orally to 101 patients immediately before and after every hemodialysis treatment for 6 months . To assess health-related quality of life from the patient 's perspective , the Medical Outcomes Study Short Form 36 instrument was administered before the study and at 1.5-month intervals for the duration of the study . In addition , a 10-item question naire design ed to assess common intradialytic symptoms was administered at the end of each dialysis treatment . Other parameters analyzed included Kt/V(urea ) and level of nutrition . In the 6-month group , oral L-carnitine supplementation had an early positive effect on general health ( P < 0.02 ) and physical function ( P < 0.03 ) , but the perceived effect was not sustained throughout the 6 months of the study . In the 3-month group , L-carnitine supplementation improved vitality ( P < 0.02 ) and general health ( P < 0.01 ) . There was no association between Kt/V(urea ) and perceived health-related quality of life . Serum albumin concentration was directly correlated to how patients perceived the quality of their lives Carnitine supplementation in hemodialyzed patients was studied in a double-blinded , r and omized , controlled trial in order to eluci date the effect of intravenous carnitine on renal anemia in patients treated with recombinant human erythropoietin ( rHuEPO ) . Twenty stable hemodialysis ( HD ) patients received intravenous L-carnitine after each dialysis session in a dosage of 5 ( N = 15 ) and 25 ( N = 5 ) mg/kg , respectively , together with intravenous iron saccharate ( 20 mg/HD session ) for four months and without iron for a further four months . Twenty patients received placebo instead of carnitine with an identical iron regimen . After a run-in phase of six months with a stable rHuEPO requirement , the rHuEPO dose was adjusted monthly when necessary to maintain target hemoglobin levels . At study entry ( T0 ) , plasma and red blood cell carnitine levels did not correlate significantly with the rHuEPO requirement . However , plasma free and total carnitine levels showed a significant negative correlation with erythrocyte survival time at T0 . After four months of coadministration of intravenous iron and L-carnitine ( T4 ) , the rHuEPO requirement decreased in 8 of 19 evaluable HD patients . In these responders , the weekly rHuEPO dose was decreased significantly by 36.9+/-23.3 % ( 183.7+/-131.7 at T0 vs. 126.6+/-127.9 U/kg/week at T4 , P < 0.001 ) . The rHuEPO requirement , however , was unchanged when all carnitine-treated patients were compared between T0 and T4 ( T0 : 172.0+/-118.0 vs. T4 : 152.3+/-118.8 U/kg/week , P = 0.07 , NS ) , but the erythropoietin resistance index decreased significantly in this group ( T0 : 16.0+/-11.0 vs. T4 : 13.6+/-10.5 U/kg/week/g of hemoglobin , P < 0.02 ) . The erythrocyte survival time was measured in five HD patients treated with iron and carnitine at T0 and T4 . Two out of these patients were carnitine responders and showed an increase of erythrocyte survival time of 15 and 20 % , respectively . After the withdrawal of iron supplementation , the rHuEPO requirement increased comparably in both L-carnitine- and placebo-treated patients during four more months . According to our data , L-carnitine , in addition to iron supplementation , may have an effect on erythropoietin resistance and erythrocyte survival time in HD patients . More than half of our patients , however , showed no benefit . Further studies to identify those HD patients who might have a benefit of carnitine supplementation , as well as studies concerning the optimal dosage , duration , and way of administration of carnitine supplementation and its mechanism of action , are required In a retrospective survey , 487 research projects approved by the Central Oxford Research Ethics Committee between 1984 and 1987 , were studied for evidence of publication bias . As of May , 1990 , 285 of the studies had been analysed by the investigators , and 52 % of these had been published . Studies with statistically significant results were more likely to be published than those finding no difference between the study groups ( adjusted odds ratio [ OR ] 2.32 ; 95 % confidence interval [ Cl ] 1.25 - 4.28 ) . Studies with significant results were also more likely to lead to a greater number of publications and presentations and to be published in journals with a high citation impact factor . An increased likelihood of publication was also associated with a high rating by the investigator of the importance of the study results , and with increasing sample size . The tendency towards publication
Output:
| There was no effect of L-carnitine on triglycerides , total cholesterol , or any of its fractions .
In conclusion , L-carnitine can not be recommended for treating the dyslipidemia of maintenance hemodialysis patients .
By contrast , this review suggests a promising effect of L-carnitine on anemia management . |
MS212139 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: OBJECTIVE To determine the effectiveness of community based occupational therapy on daily functioning of patients with dementia and the sense of competence of their care givers . DESIGN Single blind r and omised controlled trial . Assessors were blinded for treatment allocation . SETTING Memory clinic and day clinic of a geriatrics department and participants ' homes . PARTICIPANTS 135 patients aged > or = 65 with mild to moderate dementia living in the community and their primary care givers . INTERVENTIONS 10 sessions of occupational therapy over five weeks , including cognitive and behavioural interventions , to train patients in the use of aids to compensate for cognitive decline and care givers in coping behaviours and supervision . MAIN OUTCOME MEASURES Patients ' daily functioning assessed with the assessment of motor and process skills ( AMPS ) and the performance scale of the interview of deterioration in daily activities in dementia ( IDDD ) . Care giver burden assessed with the sense of competence question naire ( SCQ ) . Participants were evaluated at baseline , six weeks , and three months . RESULTS Scores improved significantly relative to baseline in patients and care givers in the intervention group compared with the controls ( differences were 1.5 ( 95 % confidence interval 1.3 to 1.7 ) for the process scale ; -11.7 ( -13.6 to -9.7 ) for the performance scale ; and ( 11.0 ; 9.2 to 12.8 ) for the competence scale ) . This improvement was still significant at three months . The number needed to treat to reach a clinical ly relevant improvement in motor and process skills score was 1.3 ( 1.2 to 1.4 ) at six weeks . Effect sizes were 2.5 , 2.3 , and 1.2 , respectively , at six weeks and 2.7 , 2.4 , and 0.8 , respectively , at 12 weeks . CONCLUSIONS Occupational therapy improved patients ' daily functioning and reduced the burden on the care giver , despite the patients ' limited learning ability . Effects were still present at 12 weeks , which justifies implementation of this intervention . TRIAL REGISTRATION Clinical Trials NCT00295152 [ Clinical Trials.gov ] Spouse-caregivers of Alzheimer 's disease patients were r and omly assigned to either a treatment group ( individual and family counseling , support group participation , and ad hoc consultation ) or a control group ( only routine support ) . In the first year after intake , the treatment group had less than half as many nursing home placements as the control group . This suggests that a comprehensive counseling program can reduce the socioeconomic impact of Alzheimer 's disease . Nursing home placement also was affected by the patient 's need for assistance with activities of daily living , patient income , and the age of the patients and caregivers CONTEXT Optimal treatment to postpone functional decline in patients with dementia is not established . OBJECTIVE To test a nonpharmacologic intervention realigning environmental dem and s with patient capabilities . DESIGN , SETTING , AND PARTICIPANTS Prospect i ve 2-group r and omized trial ( Care of Persons with Dementia in their Environments [ COPE ] ) involving patients with dementia and family caregivers ( community-living dyads ) recruited from March 2006 through June 2008 in Pennsylvania . INTERVENTIONS Up to 12 home or telephone contacts over 4 months by health professionals who assessed patient capabilities and deficits ; obtained blood and urine sample s ; and trained families in home safety , simplifying tasks , and stress reduction . Control group caregivers received 3 telephone calls and educational material s. MAIN OUTCOME MEASURES Functional dependence , quality of life , frequency of agitated behaviors , and engagement for patients and well-being , confidence using activities , and perceived benefits for caregivers at 4 months . RESULTS Of 284 dyads screened , 270 ( 95 % ) were eligible and 237 ( 88 % ) r and omized . Data were collected from 209 dyads ( 88 % ) at 4 months and 173 ( 73 % ) at 9 months . At 4 months , compared with controls , COPE patients had less functional dependence ( adjusted mean difference , 0.24 ; 95 % CI , 0.03 - 0.44 ; P = .02 ; Cohen d = 0.21 ) and less dependence in instrumental activities of daily living ( adjusted mean difference , 0.32 ; 95 % CI , 0.09 - 0.55 ; P = .007 ; Cohen d = 0.43 ) , measured by a 15-item scale modeled after the Functional Independence Measure ; COPE patients also had improved engagement ( adjusted mean difference , 0.12 ; 95 % CI , 0.07 - 0.22 ; P = .03 ; Cohen d = 0.26 ) , measured by a 5-item scale . COPE caregivers improved in their well-being ( adjusted mean difference in Perceived Change Index , 0.22 ; 95 % CI , 0.08 - 0.36 ; P = .002 ; Cohen d = 0.30 ) and confidence using activities ( adjusted mean difference , 0.81 ; 95 % CI , 0.30 - 1.32 ; P = .002 ; Cohen d = 0.54 ) , measured by a 5-item scale . By 4 months , 64 COPE dyads ( 62.7 % ) vs 48 control group dyads ( 44.9 % ) eliminated 1 or more caregiver-identified problems ( chi(2/1 ) = 6.72 , P = . 01 ) . CONCLUSION Among community-living dyads , a nonpharmacologic biobehavioral environmental intervention compared with control result ed in better outcomes for COPE dyads at 4 months . Although no group differences were observed at 9 months for patients , COPE caregivers perceived greater benefits . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00259454 The goal of this study was to evaluate a community-based psychoeducational-nursing intervention design ed to teach home caregivers to manage behavioral problems of persons with Alzheimer 's disease and related dementias ( ADRD ) using the Progressively Lowered Stress Threshold ( PLST ) model , and to compare this intervention with routine information and referrals for case management , community-based services , and support groups . Previous caregiver studies have overwhelmingly pointed to the adverse effects of caregiving on the caregivers ' physical and mental health , and high prevalence rates of depression among caregivers of persons with ADRD have consistently been reported . Therefore , a primary aim was to evaluate the impact of the intervention on caregivers ' affective responses , especially depression . Data from both the Profile of Moods States and the Geriatric Depression Rating Scale support the effectiveness of this intervention in decreasing depression among caregivers who received the experimental training . Additional analysis of factors associated with caregiver depression are also reported . The pivotal role of psychiatric nurses in the assessment and treatment of depression among caregivers of persons with ADRD is discussed Seven caregivers of a home-dwelling spouse with Alzheimer 's disease were trained during 12 weekly home visits to implement behavior management programs including written cuing procedures in response to repetitive verbalizations . Data from 7 trained caregivers and 7 matched control caregivers who only tracked repetitive behavior were compared . Results revealed that trained caregivers were successful at decreasing patient repetitions using written cues . Patients of control subjects showed no systematic changes in behavioral disturbances due to behavior tracking . In addition , intervention effects lasted for 16 weeks or longer and several caregivers reported applying the cuing intervention to other , nontargeted behaviors . Trained caregivers ' perceptions of their efficacy in managing difficult patient behavior improved significantly at the 3-month follow-up assessment when program staff were no longer visiting them weekly Although the literature is replete with studies examining the psychological concomitants and interventions for Alzheimer 's disease ( AD ) family caregivers , a surprisingly small amount of research exists on anxiety . Given prevalence rates suggesting that anxiety significantly impacts one in three family caregivers , brief group cognitive-behavioral therapy ( CBT ) interventions may offer assistance . To assess CBT 's effectiveness , 38 anxious AD family caregivers were recruited and r and omly assigned to a nine-week group CBT intervention or to a waitlist control . Caregivers r and omized to CBT demonstrated less anxiety on self-report and clinician-administered question naires than waitlist group participants at posttreatment and six-week follow-up assessment s. A sub sample of caregivers also demonstrated improved sleep , as assessed through actigraph measurements . Additional study is recommended with diverse anxious family caregiving groups to further investigate the effectiveness of brief CBT group interventions PURPOSE This study examines the short-term impact of two theoretically based psychoeducational small group interventions with distressed caregivers , and it also examines the role of specific moderator and mediator variables on caregiver outcomes . DESIGN AND METHODS Female participants ( N = 169 ) aged 50 and older who were caring for a community-dwelling relative with a dementing illness were r and omly assigned to one of three treatment interventions : anger management , depression management , or a wait-list control group . These interventions took place over a 3- to 4-month period . The primary outcomes examined were anger or hostile mood , depressed mood , frequency of use of positive and negative coping strategies , and perceived caregiving self-efficacy . RESULTS Significant main effects in the expected direction were found for changes in most of these measures . Participants in both anger management and depression management groups had significant reductions in their levels of anger or hostility and depression from Time 1 to Time 2 in comparison to participants in the wait-list control group . Use of positive cognitive coping strategies increased in the anger management group only . Self-efficacy significantly increased for participants in both intervention groups , and it was also demonstrated to function as a mediator of intervention effects . Pretreatment levels of depressive symptoms and anger expression style ( Anger Expression-Out ) moderated the relative effects of the two interventions on mood and coping . IMPLICATION S These data are consistent with a growing body of evidence supporting the effectiveness of skills training , in small groups , to improve both the affective states and the type of coping strategies used by caregivers . In addition , this study underscores the need to evaluate key pretreatment variables in order to determine which form of treatment may be more compatible with caregiver characteristics and thus more likely to be beneficial to individuals The current study is a controlled clinical investigation of two nonpharmacological treatments of depression in patients with Alzheimer 's disease . Two active behavioral treatments , one emphasizing patient pleasant events and one emphasizing caregiver problem solving , were compared to an equal- duration typical care condition and a wait list control . Seventy-two patient-caregiver dyads were r and omly assigned to one of four conditions and assessed pre- , post- , and at 6-months follow-up . Patients in both behavioral treatment conditions showed significant improvement in depression symptoms and diagnosis as compared with the two other conditions . These gains were maintained at 6-month follow-up . Caregivers in each behavioral condition also showed significant improvement in their own depressive symptoms , while caregivers in the two other conditions did not . Results indicate that behavioral interventions for depression are important and effective strategies for treating demented patients and their caregivers PURPOSE We determine the main outcome effects of a 12-month computer-mediated automated interactive voice response ( IVR ) intervention design ed to assist family caregivers managing persons with disruptive behaviors related to Alzheimer 's disease ( AD ) . DESIGN AND METHODS We conducted a r and omized controlled study of 100 caregivers , 51 in the usual care control group and 49 in the technology intervention group , who received yearlong access to an IVR-mediated system . The system provided caregiver stress monitoring and counseling information , personal voice-mail linkage to AD experts , a voice-mail telephone support group , and a distraction call for care recipients . We conducted analyses by using a repeated measures approach for longitudinal data and an intention-to-treat analytic approach . Outcomes included the caregiver 's appraisal of the bothersome nature of caregiving , anxiety , depression , and mastery at baseline , 6 , 12 , and 18 months . RESULTS There was a significant intervention effect as hypothesized for participants with lower mastery at baseline on all three outcomes : bother ( p = .04 ) , anxiety ( p = .01 ) , and depression ( p = .007 ) . Additionally , wives exhibited a significant intervention effect in the reduction of the bothersome nature of caregiving ( p = .02 ) . IMPLICATION S Wives who exhibited low mastery and high anxiety benefited the most from the automated telecare intervention . Findings suggest that , to optimize outcome effects , similar interventions should be tailored to match the users ' characteristics and preferences BACKGROUND The study objective was to determine the health and quality -of-life effects of moderate-intensity exercise among older women family caregivers . METHODS This 12-month r and omized controlled trial involved a volunteer sample of 100 women aged 49 to 82 years who were sedentary , free of cardiovascular disease , and caring for a relative with dementia . Participants were r and omized to 12 months of home-based , telephone-supervised , moderate-intensity exercise training or to an attention-control ( nutrition education ) program . Exercise consisted of four 30- to 40-minute endurance exercise sessions ( brisk walking ) prescribed per week at 60 % to 75 % of heart rate reserve based on peak treadmill exercise heart rate . Main out
Output:
| Most positive effects were found in caregivers of people with a diagnosis of ' dementia not otherwise specified ' and in the subgroup of female caregivers .
Examples of outcomes were decreased depression and improved self-efficacy .
CONCLUSIONS This study gives a first overview of successful psychosocial interventions in subgroups of caregivers of people with dementia . |
MS212140 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: PURPOSE Dry eye syndrome ( DES ) is believed to be one of the most common ocular problems in the United States ( US ) , particularly among older women . However , there are few studies describing the magnitude of the problem in women and how this may vary with demographic characteristics . DESIGN Cross-sectional prevalence survey . METHODS STUDY POPULATION we surveyed 39,876 US women participating in the Women 's Health Study about a history of diagnosed DES and dry eye symptoms . MAIN OUTCOME MEASURE we defined DES as the presence of clinical ly diagnosed DES or severe symptoms ( both dryness and irritation constantly or often ) . We calculated the age-specific prevalence of DES and adjusted the overall prevalence to the age distribution of women in the US population . We used logistic regression to examine associations between DES and other demographic factors . RESULTS The prevalence of DES increased with age , from 5.7 % among women < 50 years old to 9.8 % among women aged > or = 75 years old . The age-adjusted prevalence of DES was 7.8 % , or 3.23 million women aged > or = 50 in the US . Compared with Whites , Hispanic ( odds ratio [ OR ] = 1.81 , confidence interval [ CI ] = 1.18 - 2.80 ) and Asian ( OR = 1.77 , CI = 1.17 - 2.69 ) women were more likely to report severe symptoms , but not clinical ly diagnosed DES . There were no significant differences by income ( P([trend ] ) = .78 ) , but more educated women were less likely to have DES ( P([trend ] ) = .03 ) . Women from the South had the highest prevalence of DES , though the magnitude of geographic differences was modest . CONCLUSIONS Dry eye syndrome leading to a clinical diagnosis or severe symptoms is prevalent , affecting over 3.2 million American women middle-aged and older . Although the condition is more prevalent among older women , it also affects many women in their 40s and 50s . Further research is needed to better underst and DES and its impact on public health and quality of life PURPOSE To examine whether low-dose aspirin ( 325 mg on alternate days ) reduces the risk of age-related cataract and subtypes . This report extends previous findings , including both subtypes and additional newly identified incident cases since the earlier report . METHODS All 20,979 participants in the Physicians ' Health Study , a r and omized trial of aspirin and beta-carotene among U.S. male physicians age 40 - 84 in 1982 , who did not report cataract at baseline were included . Average follow-up was five years . The main outcome measure was incident , age-related cataract responsible for a reduction in best-corrected visual acuity to 20/30 or worse , based on self-report confirmed by medical record review . RESULTS 501 age-related cataracts were diagnosed during follow-up , including 416 with nuclear sclerosis and 212 with a posterior subcapsular component ; 318 cataracts progressed to surgical extraction . Overall , there were 245 cataracts in the aspirin group and 256 in the placebo group ( relative risk [ RR ] , 0.94 ; 95 % confidence interval [ CI ] , 0.79 to 1.13 ; P = 0.52 ) . Cataract extraction s were 19 % less frequent in the aspirin than in the placebo group ( RR , 0.81 ; 95 % CI , 0.65 to 1.01 ; P = 0.06 ) . In subgroup analyses of subtypes , aspirin takers had a lower risk of posterior subcapsular cataract ( RR , 0.74 ; 95 % CI , 0.57 to 0.98 ; P = 0.03 ) but not nuclear sclerosis ( RR , 0.96 ; 95 % CI , 0.79 to 1.16 ; P = 0.65 ) cataract . CONCLUSIONS Overall , these r and omized trial data tend to exclude a large benefit of five years of low-dose aspirin therapy on cataract development and extraction . The data are compatible with a modest benefit on cataract extraction for this duration of aspirin therapy . Subgroup analyses raise the possibility of a modest , but potentially important , protective effect of aspirin on posterior subcapsular cataract , a particularly disabling subtype Purpose To assess the additive effect of diquafosol tetrasodium on sodium hyaluronate monotherapy in patients with dry eye syndrome . Methods This study evaluated 64 eyes of 32 patients ( age : 62.6±12.8 years ( mean±SD ) ) in whom treatment with 0.1 % sodium hyaluronate was insufficiently responsive . The eyes were r and omly assigned to one of the two regimens in each patient : topical administration of sodium hyaluronate and diquafosol tetrasodium in one eye , and that of sodium hyaluronate in the other . Before treatment , and 2 and 4 weeks after treatment , we determined tear volume , tear film break-up time ( BUT ) , fluorescein and rose bengal vital staining scores , subjective symptoms , and adverse events . Results We found a significant improvement in BUT ( P=0.049 , Dunnett test ) , fluorescein and rose bengal staining scores ( P=0.02 ) , and in subjective symptoms ( P=0.004 for dry eye sensation , P=0.02 for pain , and P=0.02 for foreign body sensation ) 4 weeks after treatment in the diquafosol eyes . On the other h and , we found no significant change in these parameters after treatment in the control eyes . Conclusions In dry eyes , where sodium hyaluronate monotherapy was insufficient , diquafosol tetrasodium was effective in improving objective and subjective symptoms , suggesting its viability as an option for the additive treatment of such eyes Purpose : The aim of this study was to evaluate the treatment effect of diquafosol 3 % with preservative-free sodium hyaluronate 0.1 % eye drops in dry eye syndrome . Methods : In total , 150 patients with dry eye syndrome were divided r and omly into 3 groups . Group 1 ( 50 patients ) was treated 4 times daily with preserved sodium hyaluronate 0.1 % , group 2 ( 50 patients ) was treated 4 times daily with diquafosol 3 % , and group 3 ( 50 patients ) was treated 4 times daily with diquafosol 3 % and preservative-free sodium hyaluronate 0.1 % eye drops for 3 months . Ocular surface disease index ( OSDI ) score , tear film break-up time , Schirmer I test , corneal fluorescein staining , and impression cytology were evaluated . Results : There were significant improvements in the OSDI score , tear film break-up time , Schirmer I score , fluorescein and Rose Bengal staining , goblet cell density , and impression cytological findings in groups 2 and 3 compared with those for group 1 in patients with dry eye syndrome at 1 , 2 , and 3 months ( P < 0.05 ) . There were statistically significant improvements in the OSDI score ( −8.48 ± 0.97 , −5.69 ± 0.78 ; P = 0.02 ) , fluorescein ( −1.43 ± 0.21 , −1.02 ± 0.18 ; P = 0.03 ) , and Rose Bengal staining ( −1.12 ± 0.26 , −0.75 ± 0.12 ; P = 0.03 ) , goblet cell density ( 89.65 ± 14.39 , 70.36 ± 16.75 ; P = 0.03 ) , and impression cytological findings ( −0.53 ± 0.12 , −0.34 ± 0.90 ; P = 0.01 ) in group 3 compared with those in group 2 at 3 months . Conclusions : Treatment with diquafosol 3 % with preservative-free sodium hyaluronate 0.1 % was more effective than diquafosol 3 % monotherapy or treatment with preserved sodium hyaluronate 0.1 % in dry eye syndrome . Preservative-free sodium hyaluronate 0.1 % eye drops can increase the effect of diquafosol 3 % in dry eye syndrome Activation of P2Y2 receptors in various tissues results in secretion of ions , fluid and mucin . In situ hybridization experiments on fresh primate tissue confirm the presence of mRNA coding for the gene expression of the P2Y2 receptor in the conjunctiva and the meibomian gl and . Topical ocular administration of nucleotides causes increased chloride and mucin secretion , as well as fluid transport . These pharmacologic findings lead to the hypothesis that P2Y2 receptor agonists may have therapeutic efficacy in diseases of impaired ocular hydration Purpose : To investigate the effects of diquafosol sodium ( DQS ) eye drops , a purinergic P2Y2 receptor agonist , on tear film stability in patients with unstable tear film ( UTF ) . Methods : Two prospect i ve studies were conducted . One was an exploratory nonr and omized trial on 39 eyes with dry eye symptoms and short tear film break-up time ( BUT ) , but without epithelial damage . Changes in symptoms , BUT , Schirmer value , and ocular surface fluorescein staining ( FS ) scores were studied for 3 months . The other was a r and omized clinical trial of DQS and artificial tears ( AT ) in 17 eyes with short BUT . Eyes with decreased Schirmer values ( ⩽5 mm ) were excluded . Changes in symptoms , BUT , FS scores , and tear film stability using continuous corneal topographic analysis were studied for 4 weeks . Results : In the exploratory study , while Schirmer values were not significantly increased , significant improvements in symptoms and BUT were noted at both 1 and 3 months . In the r and omized clinical trial , significant improvements in symptoms were noted in the DQS group , but not in the AT group , at 2 weeks . BUT was significantly prolonged in the DQS group at 4 weeks but not in the AT group . No significant changes were noted in FS scores or tear film stability . Conclusions : DQS improved subjective symptoms and prolonged BUT in eyes with UTF not associated with low tear secretion and ocular surface epithelial damage . Because many patients who have UTF are refractory to conventional treatments , DQS may offer benefits in the treatment of dry eyes
Output:
| Topical diquafosol seems to be a safe therapeutic option for the treatment of dry eye .
However , the topical administration of diquafosol seems to be beneficial in improving the integrity of the epithelial cell layer of the ocular surface and mucin secretion in patients with dry eyes . |
MS212141 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: BACKGROUND Sore nipples in breast-feeding mothers are a common cause of premature weaning , and are difficult to treat owing to recurrent trauma and exposure to the infant 's oral flora . OBJECTIVE To compare the safety and efficacy of a hydrogel moist wound dressing ( Elasto-gel , Southwest Technologies Inc , Baltimore , Md ) with the use of breast shells and lanolin cream in the treatment of maternal sore nipples associated with breast-feeding . DESIGN R and omized controlled trial comparing the above treatments for sore nipples . Patients were seen for a maximum of 3 follow-up visits within 10 days , or until the resolution of symptoms . SETTING The Maternal-Infant Lactation Center at the Mercy Hospital of Pittsburgh , Pittsburgh , Pa , a tertiary care teaching hospital in inner-city Pittsburgh . PATIENTS A referred sample of 42 breast-feeding women who presented to the Maternal-Infant Lactation Center for the treatment of sore nipples . All patients with breast infection or chronic unrelated pain conditions were excluded from the study . INTERVENTION After informed consent , patients were r and omized to receive either a hydrogel wound dressing or breast shells and lanolin . All patients underwent a history , physical examination of the infant and the mother 's breasts , assessment of breast-feeding technique , and breast-feeding instruction . MAIN OUTCOME MEASURES The degree of pain on self-report question naires and the change in scores for physical examination , breast-feeding technique , and pain behaviors during breast-feeding . RESULTS Although both treatments , in association with instruction in breast-feeding technique , were effective , greater improvement was seen in the group using breast shells and lanolin . This reached statistical significance for physician-rated healing ( P<.01 ) and self-reported pain ( P<.05 ) . There were significantly more infections in the dressing group ( P<.05 ) , which result ed in early discontinuation of the study . CONCLUSIONS Prevention of sore nipples by teaching proper technique on the initiation of breast-feeding should be instituted . For those cases in which sore nipples do develop , breast shells and lanolin in association with instruction in breast-feeding technique are more effective than moist wound dressings . Lanolin and shells should remain first-line therapy BACKGROUND Nipple soreness is one reason why breastfeeding women wean their infants . This study examined the effectiveness of three topical agents -- USP-modified lanolin , warm water compresses , and expressed breast milk with air drying -- in alleviating nipple pain , and if early predictors of breastfeeding at six weeks could be determined . METHODS One hundred seventy-seven breastfeeding , primiparous women were r and omly assigned to one of four groups . All women received education about breastfeeding technique . Numeric rating scales were used to discriminate levels of pain intensity , pain affect , and strength of sucking on day 1 . Participants were interviewed by telephone on postpartum days 4 , 7 , and 14 , and during week 6 using the same scales . RESULTS No significant differences were found among groups for pain intensity , pain affect , or duration of breastfeeding . Results of a logistic regression indicated that older mothers and those who were exclusively breastfeeding ( no supplemental feeding ) were most likely to be breastfeeding six weeks postpartum . Raw scores supported the use of warm compresses . CONCLUSION Further investigation is required into ways of supporting young mothers and how caregivers provide support to breastfeeding mothers in the early weeks after childbirth OBJECTIVE To evaluate effectiveness of water versus tea bag compresses in treatment of sore nipples during breastfeeding . DESIGN Prospect i ve , r and omized trial . SETTING Mother-infant care wards in a tertiary care teaching hospital . PARTICIPANTS Sixty-five primiparae with sore nipples who were breastfeeding after a vaginal delivery at 37 or more weeks gestation , who were 36 hours or less postpartum , and had combined mother-infant care . INTERVENTIONS Participants were assigned r and omly to one of six treatment groups with one of three regimens ( tea bag compress , water compress , or no compress ) r and omly assigned to right or left sides . Participants applied the treatments at least four times a day , from Days 1 to 5 postpartum . MAIN OUTCOME MEASURE Reduction of nipple pain . RESULTS Tea bag and water compresses were more effective than no treatment , with no statistically significant difference between the two types of compresses . CONCLUSION Warm water or tea bag compresses are an inexpensive , equally effective treatment for sore nipples during the early postpartum period OBJECTIVE To examine various comfort measures and evaluate their effects in alleviating nipple soreness . DESIGN Prospect ively r and omized , experimental study . SETTING Postpartum unit of a community teaching hospital . PATIENTS Seventy-three primiparous , postpartum , breastfeeding women . INTERVENTIONS Subjects were r and omly assigned to four groups , with all women receiving instruction about breastfeeding and using one of the following treatments : warm moist tea bag compress , warm water compress , expressed milk massaged into the nipple and areola and air dried , instruction only ( control group ) . The subjects completed a question naire each morning for 7 days regarding nipple soreness . MAIN OUTCOME MEASURE Effect of treatments on postpartum nipple pain . RESULTS Subjects in the warm water compress group demonstrated significantly less pain on Day 3 than did the tea or breast milk group . CONCLUSIONS Anticipatory guidance by obstetric nurses may assist breastfeeding women in treating their pain nonpharmacologically This study was design ed to evaluate whether maintenance of a moist environment on the nipple skin during the first week of breast-feeding would improve damaged nipple skin condition , as indicated by the presence of eschar , erythema , and fissures , and reduce pain . Fifty White women applied a polyethylene film dressing with a perimeter adhesive system to a r and omly determined nipple . The dressing was present at all times except during feeding . Subjects were assessed every 48 hours ( four times ) over 7 days . Serial photographic slides were obtained and assessed for skin characteristics . Nipple pain was self-rated with a verbal descriptor scale . Use of an occlusive film dressing on nipple skin during the first week of breast-feeding appeared to have limited influence on improvement in damaged skin condition . Summary scores indicated significant reduction in the amount of eschar on the surface of the nipple . There were no differences in erythema intensity or fissure severity . Use of a dressing significantly reduced nipple pain during the study period Sore and cracked nipples are common and may represent an obstacle to successful breastfeeding . In Italy , it is customary for health professionals to prescribe some type of ointment to prevent or treat sore and cracked nipples . The efficacy of these ointments is insufficiently documented . The incidence of sore and cracked nipples was compared between mothers given routine nipple care , including an ointment ( control group ) , and mothers instructed to avoid the use of nipple creams and other products ( intervention group ) . Breastfeeding duration was also compared between the two groups . Eligible mothers were r and omly assigned , after informed consent , to one of the two groups . No difference was found between the control ( n=96 ) and the intervention group ( n=123 ) in the incidence of sore and cracked nipples and in breastfeeding duration . However , several factors were associated with sore nipples and with breastfeeding duration . The use of a pacifier and of a feeding bottle in the hospital were both associated with sore nipples at discharge ( p=0.02 and p=0.03 , respectively ) . Full breastfeeding up to 4 months postpartum was significantly associated with the following early practice s : breastfeeding on dem and , rooming-in at least 20 hours/day , non-use of formula and pacifier , no test-weighing at each breastfeed . The incidence of sore and cracked nipples and the duration of breastfeeding were not influenced by the use of a nipple ointment . Other interventions , such as providing the mother with guidance and support on positioning and latching , and modifications of hospital practice s may be more effective in reducing nipple problems OBJECTIVE To assess whether an antenatal teaching session on position and attachment of the baby on the breast had an effect on postnatal nipple pain , nipple trauma and breast feeding duration . The study was planned as a pilot study to allow an adequate sample size to be calculated for a larger study . DESIGN An observer blind experimental design was used . Women were r and omly assigned to either the experimental group teaching session or the control group . SETTING One public hospital in Western Australia . PARTICIPANTS 70 primiparae who intended to breast feed their baby were recruited from the antenatal clinic of the study hospital at 36 weeks ' gestation . INTERVENTION Antenatal group sessions on position and attachment of the baby on the breast were conducted by a lactation consultant . MEASUREMENTS AND FINDINGS During the first four postnatal days , position and attachment was measured by LATCH ( Latch on , Audible swallow , Type of nipple , Comfort and Help ) ( Jensen et al 1994 ) , nipple pain was measured by the Visual Analogue Scale ( VAS ) and nipple trauma was measured by the Nipple Trauma Index ( NTI ) . The analysis of variance ( ANOVA ) results indicated that the women in the experimental group were better able to attach the baby on the breast and had significantly less nipple pain and trauma than the control group . At six weeks postnatally , 31 of the 35 women in the experimental group were breast feeding compared to 10 of the 35 in the control group . CONCLUSIONS AND IMPLICATION S These initial findings suggest that midwives can make the best use of decreasing re sources by using practical ' h and s on ' antenatal group teaching as an effective strategy to increase breast feeding rates BACKGROUND Although lactation experts suggest that a correct positioning and attachment technique reduces breastfeeding problems and enhances long-term breastfeeding , evidence from r and omized trials is lacking . The objective of this study was to evaluate the effect of postpartum positioning and attachment education on breastfeeding outcomes in first-time mothers . METHOD A r and omized trial was performed in a public hospital in Adelaide , South Australia , where 160 first-time mothers were r and omly allocated to receive either structured one-to-one education ( experimental group ) or usual postpartum care ( control group ) within 24 hours of birth . The primary outcome was breastfeeding at 6 weeks and 3 and 6 months postpartum ; other outcomes were nipple pain and trauma in hospital and at 6 weeks and 3 and 6 months , and satisfaction with breastfeeding . RESULTS No significant differences occurred in breastfeeding rates between the groups at each endpoint , although a trend in the direction of lower rates was seen at each endpoint in the experimental group . This group reported less nipple pain on days 2 ( p = 0.004 ) and 3 ( p = 0.04 ) , but this was not sustained on follow-up . No differences were observed in nipple trauma in hospital or in self-reported nipple pain and /or trauma at the three endpoints . Experimental group women were less satisfied with breastfeeding at 3 and 6 months postpartum when using a one-item measure ; however , a multiple-item measure showed no significant differences at the three endpoints . CONCLUSIONS The intervention did not increase breastfeeding duration at any assessment time or demonstrate any differences between the groups on secondary outcomes . The trend toward lower breastfeeding rates in the experimental group suggests a need for a larger trial to evaluate whether or nor postpartum positioning and attachment education may negatively affect breastfeeding
Output:
| The authors of this review recommend full consideration be given to the sample size and study setting prior to implementation of the review recommendations in order to determine applicability to varied clinical setting s. The results section highlights sample size issues for each included study .With this limited evidence , no single intervention was identified that offers a dramatic effect in terms of treating pain and or trauma in breast-feeding women .
However , there is potential for some benefits for reducing pain and increasing comfort and thereby maximising breast-feeding duration .
CONCLUSIONS In terms of prevention , warm water compresses are recommended for the prevention of nipple pain , and simply keeping the nipples clean and dry is recommended for the prevention of cracked nipples .
In terms of treatment , warm water compresses are recommended for the reduction of nipple pain , and expressed breast-milk reduces the duration of cracked nipples .
Hydrogel dressings were associated with a high incidence of infections and their use can not be recommended . |
MS212142 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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***EXAMPLES***
Input: Testosterone has immune-modulating properties , and current in vitro evidence suggests that testosterone may suppress the expression of the proinflammatory cytokines TNFalpha , IL-1beta , and IL-6 and potentiate the expression of the antiinflammatory cytokine IL-10 . We report a r and omized , single-blind , placebo-controlled , crossover study of testosterone replacement ( Sustanon 100 ) vs. placebo in 27 men ( age , 62 + /- 9 yr ) with symptomatic and rogen deficiency ( total testosterone , 4.4 + /- 1.2 nmol/liter ; bioavailable testosterone , 2.4 + /- 1.1 nmol/liter ) . Compared with placebo , testosterone induced reductions in TNFalpha ( -3.1 + /- 8.3 vs. 1.3 + /- 5.2 pg/ml ; P = 0.01 ) and IL-1beta ( -0.14 + /- 0.32 vs. 0.18 + /- 0.55 pg/ml ; P = 0.08 ) and an increase in IL-10 ( 0.33 + /- 1.8 vs. -1.1 + /- 3.0 pg/ml ; P = 0.01 ) ; the reductions of TNFalpha and IL-1beta were positively correlated ( r(S ) = 0.588 ; P = 0.003 ) . In addition , a significant reduction in total cholesterol was recorded with testosterone therapy ( -0.25 + /- 0.4 vs. -0.004 + /- 0.4 mmol/liter ; P = 0.04 ) . In conclusion , testosterone replacement shifts the cytokine balance to a state of reduced inflammation and lowers total cholesterol . Twenty of these men had established coronary disease , and because total cholesterol is a cardiovascular risk factor , and proinflammatory cytokines mediate the development and complications associated with atheromatous plaque , these properties may have particular relevance in men with overt vascular disease We conducted a prospect i ve , nested , case-control study of inflammatory markers as predictors of type 2 diabetes among 32,826 women who provided blood sample s in 1989 through 1990 in the Nurses ' Health Study . Among women free of diabetes , cardiovascular disease , or cancer at baseline , 737 had developed diabetes by 2000 . Control women ( n = 785 ) were selected matched on age , fasting status , race , and BMI for cases in the top BMI decile . Baseline levels of tumor necrosis factor (TNF)-alpha receptor 2 , interleukin (IL)-6 , and C-reactive protein ( CRP ) were significantly higher among case than control subjects ( all P < /= 0.001 ) . After adjusting for BMI and other lifestyle factors , all three biomarkers significantly predicted diabetes risk ; the odds ratios ( ORs ) comparing extreme quintiles were 1.64 ( 95 % CI 1.10 - 2.45 ) for TNF-alphaR2 , 1.91 ( 1.27 - 2.86 ) for IL-6 , and 4.36 ( 2.80 - 6.80 ) for CRP ( P for trend < 0.001 for all biomarkers ) . In a multivariate model simultaneously including the three biomarkers , only CRP levels were significantly associated with risk of diabetes ( OR comparing extreme quintiles of CRP = 3.99 , P for trend < 0.001 ) . These data support the role of inflammation in the pathogenesis of type 2 diabetes . Elevated CRP levels are a strong independent predictor of type 2 diabetes and may mediate associations of TNF-alphaR2 and IL-6 with type 2 diabetes Serum and rogen levels decline with aging in normal males , such that a significant number of men over 60 yr of age will have a mean serum total testosterone ( T ) level near the low end of the normal adult range . It is not known whether lower T levels in older men have an effect on and rogen-responsive organ systems , such as muscle , bone , bone marrow , and prostate , nor are there data to evaluate the relative benefits and risks of T supplementation in older men . We assessed the physiological and biochemical effects of T therapy in 13 healthy men , 57 - 76 yr old , who had low or borderline low serum T levels ( < or = 13.9 nmol/L ) . Intramuscular testosterone enanthate ( TE ; 100 mg weekly ) and placebo injections were given for 3 months each . Before treatment and at the end of both 3-month treatment regimens , lean body mass , body fat , biochemical parameters of bone turnover , hematological parameters , lipoprotein profiles , and prostate parameters [ such as prostate-specific antigen ( PSA ) ] were evaluated . Serum T levels rose in all subjects with TE treatment , such that the lowest level of T during a week 's period was 19.7 + /- 0.7 nmol/L ( mean + /- SE ) . After 3 months of TE treatment , lean body mass was significantly increased , and urinary hydroxyproline excretion was significantly depressed . With TE treatment , there was a significant increase in hematocrit , a decline in total cholesterol and low density lipoprotein cholesterol , and a sustained increase in serum PSA levels . Placebo treatment led to no significant changes in any of these parameters . We conclude that short term ( 3 months ) TE supplementation to healthy older men who have serum T levels near or below the lower limit of normal for young adult men results in an increase in lean body mass and possibly a decline in bone resorption , as assessed by urinary hydroxyproline excretion , with some effect on serum lipoproteins , hematological parameters , and PSA . The sustained stimulation of PSA and the increase in hematocrit that occur with physiological TE supplementation suggest that older men should be screened carefully and followed periodically throughout T therapy We recently described a connection between and rogens and ghrelin in women affected by the polycystic ovary syndrome . To further investigate the interaction between sex steroids and ghrelin , we investigated circulating ghrelin levels in a group of hypogonadal men before and after therapeutic intervention aim ing at normalization low testosterone ( T ) concentrations . Seven hypogonadal men were compared with nine overweight/moderately obese men matched for body mass index and body fat distribution parameters , as well as with 10 normal weight controls . Total and free T and plasma ghrelin levels were significantly lower in the hypogonadal men than in the control groups . Hypogonadal men also had a significantly higher insulin resistance state . Ghrelin levels were positively correlated with both total and free T concentrations . A significant correlation was also found between ghrelin and the anthropometric parameters and the insulin resistance indexes . However , in a multiple regression analysis in which a correction for all covariants was performed , only the relationship with total and free T persisted . After the 6-month replacement T therapy , ghrelin levels of hypogonadal patients increased and did not differ significantly in comparison with both control groups . The positive correlation between ghrelin and and rogens still persisted after T replacement therapy , after adjusting for confounding variables . These data further indicate that sex hormones modulate circulating ghrelin concentrations in humans . This may be consistent with the concept that ghrelin may exert a relevant role in the endocrine network connecting the control of the reproductive system with the regulation of energy balance We evaluated the association of hemostatic factors with insulin resistance in relation to reproductive hormones including FSH , estradiol , testosterone , and SHBG . SHBG was used to calculate the free estradiol index and free and rogen index . We studied 3,200 women , aged 42 - 52 yr , in the Study of Women 's Health Across the Nation , a prospect i ve multiethnic study of the menopausal transition . We measured the hemostatic factors , fibrinogen , factor VIIc , tissue plasminogen activator ( t-PA ) , and plasminogen activator inhibitor type 1 ( PAI-1 ) , as well as glucose and insulin to calculate insulin resistance . After adjustment for body mass index , site , and ethnicity , SHBG was correlated with PAI-1 ( partial r = -0.30 ) and t-PA ( partial r = -0.12 ) . Although testosterone was associated with t-PA ( partial r = 0.13 ) and PAI-1 ( partial r = 0.07 ) , free and rogen index was strongly correlated with t-PA ( partial r = 0.18 ) and PAI-1 ( partial r = 0.26 ) . SHBG modified the association of hemostatic factors with insulin resistance . Women with greater insulin resistance had lower SHBG and higher PAI-1 . Estrogen measures were not associated with insulin resistance . The influence of sex hormones on hemostatic factors and insulin resistance is poorly understood . SHBG , which influences the amount of bioavailable hormone , significantly modified the association of PAI-1 and t-PA with insulin resistance . The longitudinal Study of Women 's Health Across the Nation will help us discern whether this interaction contributes to heart disease and diabetes among postmenopausal women CONTEXT GnRH agonists markedly increase fat mass in men with prostate cancer , but little is known about the effects of treatment on insulin sensitivity . OBJECTIVE The objective of the study was to assess the effects of short-term GnRH agonist treatment on insulin sensitivity . DESIGN This was a prospect i ve 12-wk study . SETTING The study was conducted at a general clinical research center . PATIENTS OR OTHER PARTICIPANTS We studied 25 men with locally advanced or recurrent prostate cancer , no radiographic evidence of metastases , no history of diabetes mellitus , and no evidence of diabetes mellitus at baseline visit . INTERVENTION Leuprolide depot and bicalutamide were used in the study . MAIN OUTCOME MEASURES Oral glucose tolerance tests and body composition assessment by dual-energy x-ray absorptiometry were performed at baseline and wk 12 . The primary study outcome was change in insulin sensitivity index . RESULTS Mean ( + /- se ) percentage fat body mass increased by 4.3 + /- 1.3 % from baseline to wk 12 ( P = 0.002 ) . Insulin sensitivity index decreased by 12.9 + /- 7.6 % ( P = 0.02 ) . Insulin sensitivity by homeostatic model assessment decreased by 12.8 + /- 5.9 % ( P = 0.02 ) . Fasting plasma insulin levels increased by 25.9 + /- 9.3 % ( P = 0.04 ) . Mean glycosylated hemoglobin also increased significantly ( P < 0.001 ) . CONCLUSIONS Short-term treatment with leuprolide and bicalutamide significantly increased fat mass and decreased insulin sensitivity in men with prostate cancer . These observations suggest that GnRH agonists may increase the risk of diabetes mellitus and cardiovascular disease in older men Mathematical methods exist to determine the fractions of sex hormones bound to albumin , bound to sex hormone binding globulin ( SHBG ) , or unbound , using total hormone concentration and SHBG concentration . We used data from eight prospect i ve studies of postmenopausal women to assess the validity of these estimates for fractions of estradiol ( E2 ) and to investigate the impact of using calculated values in breast cancer relative risk ( RR ) models . Comparisons were made between measured and calculated concentrations of free and non-SHBG-bound E2 in four studies . Relationships between the hormone fractions were investigated and a sensitivity analysis of the calculation performed . Breast cancer RRs were estimated using conditional logistic regression by quintiles of free E2 . There is a high correlation ( r > 0.91 ) between calculated and measured values of both free and non-SHBG-bound E2 . The calculation is highly sensitive to total hormone concentration but is relatively insensitive to SHBG concentration . In studies with both measured and calculated values , the RRs of breast cancer by quintile of free E2 were almost identical for both estimates ; using calculated values in all possible studies the RR in the highest compared with the lowest quintile of free E2 was 2.29 ( 95 % confidence interval , 1.65 - 3.19 ) . The mathematical method used to calculate fractions of E2 is valid , and RR analyses using calculated values produce similar results to those using measured values . This suggests that for epidemiological studies , it is only necessary to measure total E2 concentration and SHBG concentration , with hormone fractions being obtained by calculation , producing savings in cost , time , and serum The objective of this study was to assess the effects of oral testosterone supplementation therapy on glucose homeostasis , obesity and sexual function in middle-aged men with type 2 diabetes and mild and rogen deficiency . Forty-eight middle-aged men , with type 2 diabetes , ( visceral ) obesity and symptoms of and rogen deficiency , were included in this open-label study . Twenty-four subjects received testosterone undecanoate ( TU ; 120 mg daily , for 3 months ) ; 24 subjects received no treatment . Body composition was analyzed by bio-impedance . Parameters of metabolic control were determined . Symptoms of and rogen deficiency and erectile dysfunction were scored by self-administered question naires . TU had a positive effect on ( visceral ) obesity : statistically significant reduction in body weight ( 2.66 % ) , waist-hip ratio (
Output:
| This systematic review indicates that endogenous sex hormones may differentially modulate glycemic status and risk of type 2 diabetes in men and women .
High testosterone levels are associated with higher risk of type 2 diabetes in women but with lower risk in men ; the inverse association of SHBG with risk was stronger in women than in men |
MS212143 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Background Arthroscopic partial meniscectomy ( APM ) is extensively used to relieve pain in patients with symptomatic meniscal tear ( MT ) and knee osteoarthritis ( OA ) . Recent studies have failed to show the superiority of APM compared to other treatments . We aim to examine whether existing evidence is sufficient to reject use of APM as a cost-effective treatment for MT+OA . Methods We built a patient-level microsimulation using Monte Carlo methods and evaluated three strategies : Physical therapy ( ‘ PT ’ ) alone ; PT followed by APM if subjects continued to experience pain ( ‘ Delayed APM ’ ) ; and ‘ Immediate APM ’ . Our subject population was US adults with symptomatic MT and knee OA over a 10 year time horizon . We assessed treatment outcomes using societal costs , quality -adjusted life years ( QALYs ) , and calculated incremental cost-effectiveness ratios ( ICERs ) , incorporating productivity costs as a sensitivity analysis . We also conducted a value-of-information analysis using probabilistic sensitivity analyses . Results Calculated ICERs were estimated to be $ 12,900/QALY for Delayed APM as compared to PT and $ 103,200/QALY for Immediate APM as compared to Delayed APM . In sensitivity analyses , inclusion of time costs made Delayed APM cost-saving as compared to PT . Improving efficacy of Delayed APM led to higher incremental costs and lower incremental effectiveness of Immediate APM in comparison to Delayed APM . Probabilistic sensitivity analyses indicated that PT had 3.0 % probability of being cost-effective at a willingness-to-pay ( WTP ) threshold of $ 50,000/QALY . Delayed APM was cost effective 57.7 % of the time at WTP = $ 50,000/QALY and 50.2 % at WTP = $ 100,000/QALY . The probability of Immediate APM being cost-effective did not exceed 50 % unless WTP exceeded $ 103,000/QALY . Conclusions We conclude that current cost-effectiveness evidence does not support unqualified rejection of either Immediate or Delayed APM for the treatment of MT+OA . The amount to which society would be willing to pay for additional information on treatment outcomes greatly exceeds the cost of conducting another r and omized controlled trial on APM For many years , the National Institute for Health and Care Excellence ( NICE ) has recommended use of the EQ-5D-3L ( 3L ) [ 1 ] and its value set for the UK [ 2 ] . Since 2011 , an exp and ed-level instrument , the EQ-5D-5L ( 5L ) , has been available [ 3 ] and value sets now exist to support its use , including a value set for Engl and [ 4 , 5 ] . This poses a challenge for NICE . Should it recommend the 5L rather than the 3L ? This is neither a trivial nor merely academic matter : the choice of whether to use the 5L ( and English value set ) or the 3L ( and UK value set ) is likely to impact estimates of quality -adjusted life-years ( QALYs ) and incremental cost-effectiveness ratios ( ICERs ) . The size and direction of that impact will depend on the disease and the nature of the health problems . In general , where technologies improve self-reported health , estimates of QALY gains will often be smaller with the 5L [ 6 ] . In contrast , where technologies extend the length of life , estimates of QALY gains will be higher ( to varying degrees ) : each year of additional life is assigned a higher utility . The ultimate impact on health technology assessment ( HTA ) will depend on whether the differences between the 3L and 5L push ICERs from one side of the cost-effectiveness threshold to the other . Given the implication s for NICE ’s technology appraisal process , and other decisions informed by EQ-5D data , the Department of Health for Engl and has called for an independent validation of the 5L value set , given its relevance to policy [ 7 ] . In 2017 , NICE released a ‘ position statement ’ [ 8 ] stating that : The 3L value set continues to be used for reference-case analyses . Where 5L data have been collected , reference-case analyses should calculate utilities by mapping the 5L descriptive system data onto the 3L value set , using the van Hout et al. [ 9 ] mapping function . NICE supports sponsors of prospect i ve clinical studies continuing to use the 5L to collect data on quality of life . A further position statement is planned for August 2018 , to be informed by evidence from various studies underway . These include studies commissioned by the English Department of Health to investigate the implication s for past NICE technology appraisal s had the 5L been used , and to collect 3L and 5L data in parallel to further improve functions for mapping from one to the other . Other studies , funded by the EuroQol Group , are also underway , investigating various aspects of the relationship between the 3L and 5L across disease areas . The 3L and its UK value set has occupied a special place in NICE ’s technology appraisal process since its inception , therefore any transition will inevitably pose challenges ; for example , reconciling potential inconsistencies between past and future decisions . Given that evidence will continue to be su bmi tted using both the 3L and 5L for years to come , if both value sets are able to be used , there is a risk of inconsistency between decisions being made in the future . HTA in other countries may also face similar issues . Given the difficulties with any transition away from the 3L , is there a case for NICE to adopt the 5L as its preferred instrument ? Papers in this issue of Pharmacoeconomics , which are cited in this commentary , address that question by investigating comparative performance of the 3L and 5L BACKGROUND Acupuncture is widely used by patients with chronic pain although there is little evidence of its effectiveness . We investigated the efficacy of acupuncture compared with minimal acupuncture and with no acupuncture in patients with osteoarthritis of the knee . METHODS Patients with chronic osteoarthritis of the knee ( Kellgren grade < or = 2 ) were r and omly assigned to acupuncture ( n=150 ) , minimal acupuncture ( superficial needling at non-acupuncture points ; n=76 ) , or a waiting list control ( n=74 ) . Specialised physicians , in 28 outpatient centres , administered acupuncture and minimal acupuncture in 12 sessions over 8 weeks . Patients completed st and ard question naires at baseline and after 8 weeks , 26 weeks , and 52 weeks . The primary outcome was the Western Ontario and McMaster Universities Osteoarthritis ( WOMAC ) index at the end of week 8 ( adjusted for baseline score ) . All main analyses were by intention to treat . RESULTS 294 patients were enrolled from March 6 , 2002 , to January 17 , 2003 ; eight patients were lost to follow-up after r and omisation , but were included in the final analysis . The mean baseline-adjusted WOMAC index at week 8 was 26.9 ( SE 1.4 ) in the acupuncture group , 35.8 ( 1.9 ) in the minimal acupuncture group , and 49.6 ( 2.0 ) in the waiting list group ( treatment difference acupuncture vs minimal acupuncture -8.8 , [ 95 % CI -13.5 to -4.2 ] , p=0.0002 ; acupuncture vs waiting list -22.7 [ -27.5 to -17.9 ] , p<0.0001 ) . After 52 weeks the difference between the acupuncture and minimal acupuncture groups was no longer significant ( p=0.08 ) . INTERPRETATION After 8 weeks of treatment , pain and joint function are improved more with acupuncture than with minimal acupuncture or no acupuncture in patients with osteoarthritis of the knee . However , this benefit decreases over time OBJECTIVE The Arthritis , Diet , and Activity Promotion Trial ( ADAPT ) was a r and omized , single-blind clinical trial lasting 18 months that was design ed to determine whether long-term exercise and dietary weight loss are more effective , either separately or in combination , than usual care in improving physical function , pain , and mobility in older overweight and obese adults with knee osteoarthritis ( OA ) . METHODS Three hundred sixteen community-dwelling overweight and obese adults ages 60 years and older , with a body mass index of > or = 28 kg/m(2 ) , knee pain , radiographic evidence of knee OA , and self-reported physical disability , were r and omized into healthy lifestyle ( control ) , diet only , exercise only , and diet plus exercise groups . The primary outcome was self-reported physical function as measured with the Western Ontario and McMaster Universities Osteoarthritis Index ( WOMAC ) . Secondary outcomes included weight loss , 6-minute walk distance , stair-climb time , WOMAC pain and stiffness scores , and joint space width . RESULTS Of the 316 r and omized participants , 252 ( 80 % ) completed the study . Adherence was as follows : for healthy lifestyle , 73 % ; for diet only , 72 % ; for exercise only , 60 % ; and for diet plus exercise , 64 % . In the diet plus exercise group , significant improvements in self-reported physical function ( P < 0.05 ) , 6-minute walk distance ( P < 0.05 ) , stair-climb time ( P < 0.05 ) , and knee pain ( P < 0.05 ) relative to the healthy lifestyle group were observed . In the exercise group , a significant improvement in the 6-minute walk distance ( P < 0.05 ) was observed . The diet-only group was not significantly different from the healthy lifestyle group for any of the functional or mobility measures . The weight-loss groups lost significantly ( P < 0.05 ) more body weight ( for diet , 4.9 % ; for diet plus exercise , 5.7 % ) than did the healthy lifestyle group ( 1.2 % ) . Finally , changes in joint space width were not different between the groups . CONCLUSION The combination of modest weight loss plus moderate exercise provides better overall improvements in self-reported measures of function and pain and in performance measures of mobility in older overweight and obese adults with knee OA compared with either intervention alone Background Few population -based studies have examined the prevalence of foot pain in the general community . The aims of this study were therefore to determine the prevalence , correlates and impact of foot pain in a population -based sample of people aged 18 years and over living in the northwest region of Adelaide , South Australia . Methods The North West Adelaide Health Study is a representative longitudinal cohort study of n = 4,060 people r and omly selected and recruited by telephone interview . The second stage of data collection on this cohort was undertaken between mid 2004 and early 2006 . In this phase , information regarding the prevalence of musculoskeletal conditions was included . Overall , n = 3,206 participants returned to the clinic during the second visit , and as part of the assessment were asked to report whether they had pain , aching or stiffness on most days in either of their feet . Data were also collected on body mass index ( BMI ) ; major medical conditions ; other joint symptoms and health-related quality of life ( the Medical Outcomes Study Short Form 36 [ SF-36 ] ) . Results Overall , 17.4 % ( 95 % confidence interval 16.2 – 18.8 ) of participants indicated that they had foot pain , aching or stiffness in either of their feet . Females , those aged 50 years and over , classified as obese and who reported knee , hip and back pain were all significantly more likely to report foot pain . Respondents with foot pain scored lower on all domains of the SF-36 after adjustment for age , sex and BMI . Conclusion Foot pain affects nearly one in five of people in the community , is associated with increased age , female sex , obesity and pain in other body regions , and has a significant detrimental impact on health-related quality of life OBJECTIVE To evaluate the clinical effectiveness of manual physiotherapy and /or exercise physiotherapy in addition to usual care for patients with osteoarthritis ( OA ) of the hip or knee . DESIGN In this 2 × 2 factorial r and omized controlled trial , 206 adults ( mean age 66 years ) who met the American College of Rheumatology criteria for hip or knee OA were r and omly allocated to receive manual physiotherapy ( n = 54 ) , multi-modal exercise physiotherapy ( n = 51 ) , combined exercise and manual physiotherapy ( n = 50 ) , or no trial physiotherapy ( n = 51 ) . The primary outcome was change in the Western Ontario and McMaster osteoarthritis index ( WOMAC ) after 1 year . Secondary outcomes included physical performance tests . Outcome assessors were blinded to group allocation . RESULTS Of 206 participants recruited , 193 ( 93.2 % ) were retained at follow-up . Mean ( SD ) baseline WOMAC score was 100.8 ( 53.8 ) on a scale of 0 - 240 . Intention to treat analysis showed adjusted reductions in WOMAC scores at 1 year compared with the usual care group of 28.5 ( 95 % confidence interval ( CI ) 9.2 - 47.8 ) for usual care plus manual therapy , 16.4 ( -3.2 to 35.9 ) for usual care plus exercise therapy , and 14.5 ( -5.2 to 34.1 ) for usual care plus
Output:
| A matrix presentation of costs mapped with outcomes indicated increasing costs with either no difference or improvements in clinical effectiveness . |
MS212144 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: ABSTRACT BACKGROUND Decisions about cardiopulmonary resuscitation ( CPR ) and intubation are a core part of advance care planning , particularly for seriously ill hospitalized patients . However , these discussion s are often avoided . OBJECTIVES We aim ed to examine the impact of a video decision tool for CPR and intubation on patients ’ choices , knowledge , medical orders , and discussion s with providers . DESIGN This was a prospect i ve r and omized trial conducted between 9 March 2011 and 1 June 2013 on the internal medicine services at two hospitals in Boston . PARTICIPANTS One hundred and fifty seriously ill hospitalized patients over the age of 60 with an advanced illness and a prognosis of 1 year or less were included . Mean age was 76 and 51 % were women . INTERVENTIONThree-minute video describing CPR and intubation plus verbal communication of participants ’ preferences to their physicians ( intervention ) ( N = 75 ) or control arm ( usual care ) ( N = 75).MAIN MEASURES The primary outcome was participants ’ preferences for CPR and intubation ( immediately after viewing the video in the intervention arm ) . Secondary outcomes included : orders to withhold CPR/intubation , documented discussion s with providers during hospitalization , and participants ’ knowledge of CPR/ intubation ( five-item test , range 0–5 , higher scores indicate greater knowledge ) . RESULTS Intervention participants ( vs. controls ) were more likely not to want CPR ( 64 % vs. 32 % , p < 0.0001 ) and intubation ( 72 % vs. 43 % , p < 0.0001 ) . Intervention participants ( vs. controls ) were also more likely to have orders to withhold CPR ( 57 % vs. 19 % , p < 0.0001 ) and intubation ( 64 % vs.19 % , p < 0.0001 ) by hospital discharge , documented discussion s about their preferences ( 81 % vs. 43 % , p < 0.0001 ) , and higher mean knowledge scores ( 4.11 vs. 2.45 ; p < 0.0001 ) . CONCLUSIONS Seriously ill patients who viewed a video about CPR and intubation were more likely not to want these treatments , be better informed about their options , have orders to forgo CPR/ intubation , and discuss preferences with providers . Trial registration : Clinical trials.gov NCT01325519 Registry Name : A prospect i ve r and omized trial using video images in advance care planning in seriously ill hospitalized patients Background Previous studies have demonstrated that video of and scripted information about cardiopulmonary resuscitation ( CPR ) can be deployed during clinician – patient end-of-life discussion s. Few studies , however , examine whether video adds to verbal information-sharing . We hypothesized that video augments script-only decision-making . Methods Patients aged > 65 years admitted to hospital wards were r and omized to receive evidence -based information ( “ script ” ) vs. script plus video of simulated CPR and intubation . Patients ’ decisions registered in the hospital record , by hospital discharge were compared for the two groups . Results Fifty script-only intervention patients averaging 77.7 years were compared to 50 script+video patients with a mean age of 74.7 years . Eleven of 50 ( 22 % ) in each group declined CPR ; and an additional three ( script ) vs. four ( script+video ) refused intubation for respiratory failure . There were no differences in sex , self-reported health trajectory , functional limitations , length of stay , or mortality associated with decisions . Conclusion The rate at which verbally informed hospitalized elders opted out of resuscitation was not impacted by adding a video depiction of CPR BACKGROUND : Patient preferences regarding cardiopulmonary resuscitation ( CPR ) are important , especially during hospitalization when a patient 's health is changing . Yet many patients are not adequately informed or involved in the decision‐making process . OBJECTIVES : We examined the effect of an informational video about CPR on hospitalized patients ' code status choices . DESIGN : This was a prospect i ve , r and omized trial conducted at the Minneapolis Veterans Affairs Health Care System in Minnesota . PARTICIPANTS : We enrolled 119 patients , hospitalized on the general medicine service , and at least 65 years old . The majority were men ( 97 % ) with a mean age of 75 . INTERVENTION : A video described code status choices : full code ( CPR and intubation if required ) , do not resuscitate ( DNR ) , and do not resuscitate/do not intubate ( DNR/DNI ) . Participants were r and omized to watch the video ( n = 59 ) or usual care ( n = 60 ) . MEASUREMENTS : The primary outcome was participants ' code status preferences . Secondary outcomes included a question naire design ed to evaluate participants ' trust in their healthcare team and knowledge and perceptions about CPR . RESULTS : Participants who viewed the video were less likely to choose full code ( 37 % ) compared to participants in the usual care group ( 71 % ) and more likely to choose DNR/DNI ( 56 % in the video group vs. 17 % in the control group ) ( P < 0.00001 ) . We did not see a difference in trust in their healthcare team or knowledge and perceptions about CPR as assessed by our question naire . CONCLUSIONS : Hospitalized patients who watched a video about CPR and code status choices were less likely to choose full code and more likely to choose DNR/DNI PURPOSE Decision making regarding cardiopulmonary resuscitation ( CPR ) is challenging . This study examined the effect of a video decision support tool on CPR preferences among patients with advanced cancer . PATIENTS AND METHODS We performed a r and omized controlled trial of 150 patients with advanced cancer from four oncology centers . Participants in the control arm ( n = 80 ) listened to a verbal narrative describing CPR and the likelihood of successful resuscitation . Participants in the intervention arm ( n = 70 ) listened to the identical narrative and viewed a 3-minute video depicting a patient on a ventilator and CPR being performed on a simulated patient . The primary outcome was participants ' preference for or against CPR measured immediately after exposure to either modality . Secondary outcomes were participants ' knowledge of CPR ( score range of 0 to 4 , with higher score indicating more knowledge ) and comfort with video . RESULTS The mean age of participants was 62 years ( st and ard deviation , 11 years ) ; 49 % were women , 44 % were African American or Latino , and 47 % had lung or colon cancer . After the verbal narrative , in the control arm , 38 participants ( 48 % ) wanted CPR , 41 ( 51 % ) wanted no CPR , and one ( 1 % ) was uncertain . In contrast , in the intervention arm , 14 participants ( 20 % ) wanted CPR , 55 ( 79 % ) wanted no CPR , and 1 ( 1 % ) was uncertain ( unadjusted odds ratio , 3.5 ; 95 % CI , 1.7 to 7.2 ; P < .001 ) . Mean knowledge scores were higher in the intervention arm than in the control arm ( 3.3 ± 1.0 v 2.6 ± 1.3 , respectively ; P < .001 ) , and 65 participants ( 93 % ) in the intervention arm were comfortable watching the video . CONCLUSION Participants with advanced cancer who viewed a video of CPR were less likely to opt for CPR than those who listened to a verbal narrative Objective : To determine the relationship of electrocardiographic rhythm during cardiac arrest with survival outcomes . Design : Prospect i ve , observational study . Setting : Total of 411 hospitals in the National Registry of Cardiopulmonary Resuscitation . Patients : Total of 51,919 adult patients with pulseless cardiac arrests from April 1999 to July 2005 . Measurements and Main Results : Registry data collected included first documented rhythm , patient demographics , pre-event data , event data , and survival and neurologic outcome data . Of 51,919 indexed cardiac arrests , first documented pulseless rhythm was ventricular tachycardia ( VT ) in 3810 ( 7 % ) , ventricular fibrillation ( VF ) in 8718 ( 17 % ) , pulseless electrical activity ( PEA ) in 19,262 ( 37 % ) and asystole 20,129 ( 39 % ) . Subsequent VT/VF ( that is , VT or VF occurring during resuscitation for PEA or asystole ) occurred in 5154 ( 27 % ) , with first documented rhythm of PEA and 4988 ( 25 % ) with asystole . Survival to hospital discharge rate was not different between those with first documented VF and VT ( 37 % each , adjusted odds ratio [ OR ] ) 1.08 ; 95 % confidence interval [ CI ] 0.95–1.23 ) . Survival to hospital discharge was slightly more likely after PEA than asystole ( 12 % vs. 11 % , adjusted OR 1.1 ; 95 % CI 1.00–1.18 ) , Survival to discharge was substantially more likely after first documented VT/VF than PEA/asystole ( adjusted OR 1.68 ; 95 % CI 1.55–1.82 ) . Survival to discharge was also more likely after PEA/asystole without subsequent VT/VF compared with PEA/asystole with subsequent VT/VF ( 14 % vs. 7 % for PEA without vs. with subsequent VT/VF ; 12 % vs. 8 % for asystole without vs. with subsequent VT/VF ; adjusted OR 1.60 ; 95 % CI , 1.44–1.80 ) . Conclusions : Survival to hospital discharge was substantially more likely when the first documented rhythm was shockable rather than nonshockable , and slightly more likely after PEA than asystole . Survival to hospital discharge was less likely following PEA/asystole with subsequent VT/VF compared to PEA/asystole without subsequent VT/VF Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of an intervention to be underestimated or overestimated . The Cochrane Collaboration ’s tool for assessing risk of bias aims to make the process clearer and more PURPOSE To determine whether the use of a goals -of-care video to supplement a verbal description can improve end-of-life decision making for patients with cancer . METHODS Fifty participants with malignant glioma were r and omly assigned to either a verbal narrative of goals -of-care options at the end of life ( control ) , or a video after the same verbal narrative ( intervention ) in this r and omized controlled trial . The video depicts three levels of medical care : life-prolonging care ( cardiopulmonary resuscitation [ CPR ] , ventilation ) , basic care ( hospitalization , no CPR ) , and comfort care ( symptom relief ) . The primary study outcome was participants ' preferences for end-of-life care . The secondary outcome was participants ' uncertainty regarding decision making ( score range , 3 to 15 ; higher score indicating less uncertainty ) . Participants ' comfort level with the video was also measured . RESULTS Fifty participants were r and omly assigned to either the verbal narrative ( n = 27 ) or video ( n = 23 ) . After the verbal description , 25.9 % of participants preferred life-prolonging care , 51.9 % basic care , and 22.2 % comfort care . In the video arm , no participants preferred life-prolonging care , 4.4 % preferred basic care , 91.3 % preferred comfort care , and 4.4 % were uncertain ( P < .0001 ) . The mean uncertainty score was higher in the video group than in the verbal group ( 13.7 v 11.5 , respectively ; P < .002 ) . In the intervention arm , 82.6 % of participants reported being very comfortable watching the video . CONCLUSION Compared with participants who only heard a verbal description , participants who viewed a goals -of-care video were more likely to prefer comfort care and avoid CPR , and were more certain of their end-of-life decision making . Participants reported feeling comfortable watching the video BACKGROUND Cardiopulmonary resuscitation ( CPR ) is an important advance directive ( AD ) topic in patients with progressive cancer ; however such discussion s are challenging . OBJECTIVE This study investigates whether video educational information about CPR engenders broader advance care planning ( ACP ) discourse . METHODS Patients with progressive pancreas or hepatobiliary cancer were r and omized to an educational CPR video or a similar CPR narrative . The primary end-point was the difference in ACP documentation one month posttest between arms . Secondary end-points included study impressions ; pre- and post-intervention knowledge of and preferences for CPR and mechanical ventilation ; and longitudinal patient outcomes . RESULTS Fifty-six subjects were consented and analyzed . Rates of ACP documentation ( either formal ADs or documented discussion s ) were 40 % in the video arm ( 12/30 ) compared to 15 % in the narrative arm ( 4/26 ) , OR=3.6 [ 95 % CI : 0.9 - 18.0 ] , p=0.07 . Post-intervention knowledge was higher in both arms . Posttest , preferences for CPR had changed in the video arm but not in the narrative arm . Preferences regarding mechanical ventilation did not change in either arm . The majority of subjects in both arms reported the information as helpful and comfortable to discuss , and they recommended it to others . More deaths occurred in the video arm compared to the narrative arm , and more subjects died in hospice setting s in the video arm . CONCLUS
Output:
| Conclusions and Relevance Communication interventions are associated with patient decisions regarding do-not-resuscitate code status and better patient knowledge and may thus improve code status discussion |
MS212145 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: A triple-blind ( investigator , patient , statistician ) , r and omized , placebo-controlled , trial of Ginkgo biloba 240 mg daily was carried out . Following a 1-week control , it was given to 24 patients with sexual impairment due to antidepressant drugs . Efficacy analysis was carried out on eight males and five females on placebo and six males and five females on Ginkgo , completing the full 12 weeks of treatment . Not included were three subjects who dropped out after 6 weeks . A vali date d , sex (gender)-orientated question naire was recorded at - 1 , 0 , 1 , 3 , 6 , 9 and 12 weeks , and a non-blind follow-up for a further 6-weeks on Ginkgo . Hamilton anxiety and depression ratings were made at 0 , 6 and 12 weeks and simple global assessment s of alertness and memory . There were some spectacular individual responses in both groups , but no statistically significant differences , and no differences in side-effects Fifty partial and non-responders ( Clinical Global Impression-Sexual Function ( CGI-SF ) score>2 ) , out of 76 men who completed a 6-week , double-blind , placebo-controlled trial of sildenafil treatment for serotonergic antidepressant – associated sexual dysfunction , were eligible for an additional 6-week trial of open-label sildenafil ( 50 mg adjustable to 100 mg ) under the same protocol , with blind maintained to initial assignment . Participation ( double-blind and open-label ) required major depressive disorder in remission ( MDD-R ) and continuing antidepressant medication . Forty-three entered open-label study : 16/17 initially r and omized to sildenafil ( sildenafil/sildenafil ) and 27/33 initially r and omized to placebo ( placebo/sildenafil ) . Thirty-five of 43 ( 81 % ) achieved full response ( CGI-SF⩽2 ) : placebo/sildenafil 23/27 ( 85 % ) ; sildenafil/sildenafil 12/16 ( 75 % ) ; P<0.0001 for changes and P=0.4 between groups . Secondary measures of erectile function and overall satisfaction improved in both groups ( P<0.03 ) . Hamilton Depression Rating Scale scores improved ( placebo/sildenafil ; P⩽0.05 ) or remained stable ( sildenafil/sildenafil ) . In men with MDD-R who maintained antidepressant adherence , 81 % of double-blind partial and non-responders treated with open-label sildenafil responded fully BACKGROUND Sexual side effects are among the common reasons patients discontinue selective serotonin reuptake inhibitors ( SSRIs ) . While many antidotes have been proposed , few have been subjected to double-blind trials . Some evidence has suggested that bupropion may be an effective antidote for SSRI-induced sexual dysfunction . In this double-blind trial , the efficacy of a st and ard dose of bupropion sustained release ( SR ) is evaluated in the treatment of SSRI-induced sexual dysfunction . METHOD Patients with a history of SSRI-induced sexual side effects were r and omly assigned to adjunctive treatment with either bupropion SR 150 mg daily or placebo for 6 weeks . Assessment s of sexual function and interest included the Arizona Sexual Experiences Scale ( ASEX ) , Brief Index of Sexual Functioning , and a 10-point visual analogue scale . Efficacy was defined as a 50 % improvement on the ASEX at the end of 6 weeks . Data were collected from January 1999 to March 2001 . RESULTS Forty-one patients entered the study and completed the 6-week trial . No significant differences were seen between placebo and bupropion SR on the ASEX or on any measure of sexual functioning at the end of the trial . CONCLUSION A fixed dose of 150 mg/day of bupropion SR taken in the morning does not appear to be effective in the treatment of SSRI-induced sexual dysfunction . Additional trials will be required to define what role , if any , bupropion might have in the treatment of SSRI-induced sexual side effects Rationale Saffron ( Crocus sativus L. ) has shown aphrodisiac effects in some animal and human studies . Objectives To assess the efficacy and tolerability of saffron in fluoxetine-related sexual dysfunction . Methods This was a 4-week r and omized double-blind placebo-controlled study . Thirty-six married male patients with major depressive disorder whose depressive symptoms had been stabilized on fluoxetine and had subjective complaints of sexual impairment entered the study . The patients were r and omly assigned to saffron ( 15 mg twice per day ) or placebo for 4 weeks . International Index of Erectile Function scale was used to assess sexual function at baseline and weeks 2 and 4 . Results Thirty patients finished the study . Baseline characteristics as well as baseline and final depressive symptoms scores were similar between the two groups . Effect of time × treatment interaction on the total score was significant [ Greenhouse – Geisser-corrected , F ( 1.444 , 40.434 ) = 6.154 , P = 0.009 ] . By week 4 , saffron result ed in significantly greater improvement in erectile function ( P < 0.001 ) and intercourse satisfaction domains ( P = 0.001 ) , and total scores ( P < 0.001 ) than the placebo group . Effect of saffron did not differ significantly from that of placebo in orgasmic function ( P = 0.095 ) , overall satisfaction ( P = 0.334 ) , and sexual desire ( P = 0.517 ) domains scores . Nine patients ( 60 % ) in the saffron group and one patient ( 7 % ) in the placebo group achieved normal erectile function ( score > 25 on erectile function domain ) at the end of the study ( P value of Fisher ’s exact test = 0.005 ) . Frequency of side effects were similar between the two groups . Conclusions Saffron is a tolerable and efficacious treatment for fluoxetine-related erectile dysfunction Erectile dysfunction ( ED ) and depression are highly prevalent and frequently comorbid . Sildenafil effectively treats ED in men with depression and in men taking antidepressants . We evaluated the efficacy of sildenafil in men with depression in remission and ED . Patients with a history of ED when major depressive disorder ( MDD ) was diagnosed , which persisted after MDD was treated to remission , were r and omized to 12 weeks of treatment with sildenafil ( 50 mg , flexible ) or placebo . Efficacy was assessed using intercourse success rates , a global efficacy question ( Has treatment improved your erections ? ) , the International Index of Erectile Function ( IIEF ) and Life Satisfaction Checklist ( LSC ) . By week 12 , intercourse success rates were significantly higher among sildenafil- ( 74 % ) compared to placebo-treated patients ( 29 % ; P=0.0001 ) . About 83 % and 34 % of sildenafil- and placebo-treated patients , respectively , reported improved erections ( odds ratio=9.4 , P=0.0001 ) . IIEF scores in the sildenafil group ( n=83 ) were significantly improved compared to those in the placebo group ( n=85 ; P < 0.0001 ) . LSC sexual life item improved significantly among sildenafil- versus placebo-treated patients . The most frequently reported adverse events were transient and mild-to-moderate . Sildenafil is an effective and well-tolerated treatment for ED in patients with a history of ED at the time of MDD diagnosis , and which persisted after the MDD was treated to remission BACKGROUND The efficacy , tolerability , and effects on sexual function and satisfaction of nefazodone and sertraline were compared in a multicenter , r and omized , double-blind , parallel-group study in out patients with major depression . METHOD One hundred sixty patients , 18 years of age or older , who met DSM-III-R criteria for single or recurrent nonpsychotic major depressive episodes were r and omly assigned to 6 weeks of treatment with either nefazodone ( 100 - 600 mg/day ) or sertraline ( 50 - 200 mg/day ) . Symptoms were assessed before and during treatment using the 17-item Hamilton Rating Scale for Depression ( HAM-D-17 ) , Clinical Global Impressions ( CGI ) Improvement scale , the CGI Severity of Illness scale , and a sexual function question naire . RESULTS Of 143 patients evaluable for efficacy , 72 received sertraline and 71 received nefazodone . The mean modal daily dose at endpoint was 148 mg for sertraline and 456 mg for nefazodone . Analysis of efficacy measures ( HAM-D-17 and CGI ) showed consistent and comparable improvement in symptoms of depression for both treatment groups . Sertraline had negative effects on sexual function and satisfaction in both men and women , and nefazodone had no adverse effect on sexual well-being . Safety assessment s based on adverse events , vital sign measurements , electrocardiographs , physical examinations , and clinical laboratory tests revealed no serious adverse events or organ toxicity associated with nefazodone or sertraline administration . CONCLUSION Nefazodone and sertraline are well tolerated , and there was no statistically significant difference in their antidepressant activity . Sertraline treatment has negative effects on sexual function and performance in both sexes , while nefazodone has none . These findings may have clinical implication s when choosing antidepressant therapy CONTEXT Antidepressant-associated sexual dysfunction is a common adverse effect that frequently results in premature medication treatment discontinuation and for which no treatment has demonstrated efficacy in women . OBJECTIVE To evaluate the efficacy of sildenafil for sexual dysfunction associated with selective and nonselective serotonin reuptake inhibitors ( SRIs ) in women . DESIGN , SETTING , AND PARTICIPANTS An 8-week prospect i ve , parallel-group , r and omized , double-blind , placebo-controlled clinical trial conducted between September 1 , 2003 , and January 1 , 2007 , at 7 US research centers that included 98 previously sexually functioning , premenopausal women ( mean [ SD ] age 37.1 [ 6 ] years ) whose major depression was remitted by SRIs but who were also experiencing sexual dysfunction . INTERVENTION Forty-nine patients were r and omly assigned to take sildenafil or placebo at a flexible dose starting at 50 mg adjustable to 100 mg before sexual activity . MAIN OUTCOME MEASURES The primary outcome measure was the mean difference in change from baseline to study end ( ie , lower ordinal score ) on the Clinical Global Impression sexual function scale . Secondary measures included the Female Sexual Function Question naire , the Arizona Sexual Experience scale-female version , the University of New Mexico Sexual Function Inventory-female version , a sexual activity event log , and the Hamilton Depression Rating scale . Hormone levels were also assessed . RESULTS In an intention-to-treat analysis , women treated with sildenafil had a mean Clinical Global Impression-sexual function score of 1.9 ( 95 % confidence interval [ CI ] , 1.6 - 2.3 ) compared with those taking placebo ( 1.1 ; 95 % CI , 0.8 - 1.5 ) , with a mean end point difference of 0.8 ( 95 % CI , 0.6 - 1.0 ; P = .001 ) . Assigning baseline values carried forward to the 22 % of patients who prematurely discontinued result ed in a mean end point in the sexual function score of 1.5 ( 95 % CI , 1.1 - 1.9 ) among women taking sildenafil compared with 0.9 ( 95 % CI , 0.6 - 1.3 ) among women taking placebo with a mean end point difference of 0.6 ( 95 % CI , 0.3 - 0.8 ; P = .03 ) . Baseline endocrine levels were within normal limits and did not differ between groups . The mean ( SD ) Hamilton scores for depression remained consistent with remission in both groups ( 4.0 [ 3.6 ] ; P = .90 ) . Headache , flushing , and dyspepsia were reported frequently during treatment , but no patients withdrew because of serious adverse effects . CONCLUSION In this study population , sildenafil treatment of sexual dysfunction in women taking SRIs was associated with a reduction in adverse sexual effects . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00375297 To evaluate the possible influence of buspirone on sexual dysfunction in depressed patients treated with a selective serotonin reuptake inhibitor ( SSRI ) , we analyzed data from a placebo-controlled trial design ed to explore the efficacy of buspirone as add-on treatment for patients not responding to an SSRI alone . At baseline , all patients met the criteria for a major depressive episode according to DSM-IV and had received citalopram or paroxetine during a minimum of 4 weeks without responding to the treatment . Buspirone ( flexible dosage , 20 - 60 mg/day ) or placebo was added to the SSRI for 4 weeks ; the mean daily dose of buspirone at endpoint was 48.5 mg ( SD = 1.0 ) . Sexual dysfunction was evaluated using a structured interview . Before starting medication with buspirone or placebo , 40 % ( 47 of
Output:
| For women it remains uncertain whether sildenafil is more effective than placebo .
Data from three studies in men and women of bupropion 150 mg twice daily indicate a benefit over placebo on rating scale scores ( SMD 1.60 , 95 % CI 1.40 to 1.81 ) , but response rates in two studies of bupropion 150 mg once daily demonstrated no statistically significant difference in effect ( RR 0.62 , 95 % CI 0.09 to 4.41).Other augmentation strategies failed to demonstrate significant improvements in sexual dysfunction compared with placebo .
For men with antidepressant-induced erectile dysfunction , the addition of sildenafil or tadalafil appears to be an effective strategy .
For women with antidepressant-induced sexual dysfunction the addition of bupropion at higher doses appears to be the most promising approach studied so far |
MS212146 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Background : Individuals with dementia often experience poor quality of life ( QOL ) due to behavioral and psychological symptoms of dementia ( BPSD ) . Music therapy can reduce BPSD , but most studies have focused on patients with mild to moderate dementia . We hypothesized that music intervention would have beneficial effects compared with a no-music control condition , and that interactive music intervention would have stronger effects than passive music intervention . Methods : Thirty-nine individuals with severe Alzheimer 's disease were r and omly and blindly assigned to two music intervention groups ( passive or interactive ) and a no-music Control group . Music intervention involved individualized music . Short-term effects were evaluated via emotional response and stress levels measured with the autonomic nerve index and the Faces Scale . Long-term effects were evaluated by BPSD changes using the Behavioral Pathology in Alzheimer 's Disease ( BEHAVE-AD ) Rating Scale . Results : Passive and interactive music interventions caused short-term parasympathetic dominance . Interactive intervention caused the greatest improvement in emotional state . Greater long-term reduction in BPSD was observed following interactive intervention , compared with passive music intervention and a no-music control condition . Conclusion : Music intervention can reduce stress in individuals with severe dementia , with interactive interventions exhibiting the strongest beneficial effects . Since interactive music intervention can restore residual cognitive and emotional function , this approach may be useful for aiding severe dementia patients ’ relationships with others and improving QOL . The registration number of the trial and the name of the trial registry are UMIN000008801 and “ Examination of Effective Nursing Intervention for Music Therapy for Severe Dementia Elderly Person ” respectively Background / Aims : Numerous studies have indicated the value of music therapy in the management of patients with Alzheimer ’s disease . A recent pilot study demonstrated the feasibility and usefulness of a new music therapy technique . The aim of this controlled , r and omised study was to assess the effects of this new music therapy technique on anxiety and depression in patients with mild to moderate Alzheimer-type dementia . Methods : This was a single-centre , comparative , controlled , r and omised study , with blinded assessment of its results . The duration of follow-up was 24 weeks . The treated group ( n = 15 ) participated in weekly sessions of individual , receptive music therapy . The musical style of the session was chosen by the patient . The vali date d ‘ U ’ technique was employed . The control group ( n = 15 ) participated under the same conditions in reading sessions . The principal endpoint , measured at weeks 1 , 4 , 8 , 16 and 24 , was the level of anxiety ( Hamilton Scale ) . Changes in the depression score ( Geriatric Depression Scale ) were also analyzed as a secondary endpoint . Results : Significant improvements in anxiety ( p < 0.01 ) and depression ( p < 0.01 ) were observed in the music therapy group as from week 4 and until week 16 . The effect of music therapy was sustained for up to 8 weeks after the discontinuation of sessions between weeks 16 and 24 ( p < 0.01 ) . Conclusion : These results confirm the valuable effect of music therapy on anxiety and depression in patients with mild to moderate Alzheimer ’s disease . This new music therapy technique is simple to implement and can easily be integrated in a multidisciplinary programme for the management of Alzheimer ’s disease BACKGROUND Music therapy is a potential non-pharmacological treatment for the behavioral and psychological symptoms of dementia , but although some studies have found it to be helpful , most are small and uncontrolled . METHODS This case-control study was carried out by qualified music therapists in two nursing homes and two psychogeriatric wards . The participants were 38 patients with moderate or severe Alzheimer 's disease ( AD ) assigned r and omly to a music therapy group and a control group . RESULTS The study showed a significant reduction in activity disturbances in the music therapy group during a 6-week period measured with the Behavior Pathology in Alzheimer 's Disease Rating Scale ( BEHAVE-AD ) . There was also a significant reduction in the sum of scores of activity disturbances , aggressiveness and anxiety . Other symptoms rated by subscales of the BEHAVE-AD did not decrease significantly . Four weeks later the effects had mostly disappeared . CONCLUSIONS Music therapy is a safe and effective method for treating agitation and anxiety in moderately severe and severe AD . This is in line with the results of some non-controlled studies on music therapy in dementia Objectives : Agitation in nursing home residents with dementia leads to increase in psychotropic medication , decrease in quality of life , and to patient distress and caregiver burden . Music therapy has previously been found effective in treatment of agitation in dementia care but studies have been method ologically insufficient . The aim of this study was to examine the effect of individual music therapy on agitation in persons with moderate/severe dementia living in nursing homes , and to explore its effect on psychotropic medication and quality of life . Method : In a crossover trial , 42 participants with dementia were r and omized to a sequence of six weeks of individual music therapy and six weeks of st and ard care . Outcome measures included agitation , quality of life and medication . Results : Agitation disruptiveness increased during st and ard care and decreased during music therapy . The difference at −6.77 ( 95 % CI ( confidence interval ) : −12.71 , −0.83 ) was significant ( p = 0.027 ) , with a medium effect size ( 0.50 ) . The prescription of psychotropic medication increased significantly more often during st and ard care than during music therapy ( p = 0.02 ) . Conclusion : This study shows that six weeks of music therapy reduces agitation disruptiveness and prevents medication increases in people with dementia . The positive trends in relation to agitation frequency and quality of life call for further research with a larger sample Background Agitated behavior is a widespread problem that adversely affects the health of nursing home residents and increases the cost of their care . Objective To examine whether modifying environmental stimuli by the use of calming music and h and massage affects agitated behavior in persons with dementia . Method A four group , repeated measures experimental design was used to test the effect of a 10-minute exposure to either calming music , h and massage , or calming music and h and massage simultaneously , or no intervention ( control ) on the frequency and type of agitated behaviors in nursing home residents with dementia ( N = 68 ) . A modified version of the Cohen-Mansfield Agitation Inventory was used to record agitated behaviors . Results Each of the experimental interventions reduced agitation more than no intervention . The benefit was sustained and increased up to one hour following the intervention ( F = 6.47 , p < .01 ) . The increase in benefit over time was similar for each intervention group . When types of agitated behaviors were examined separately , none of the interventions significantly reduced physically aggressive behaviors ( F = 1.93 , p = .09 ) , while physically nonaggressive behaviors decreased during each of the interventions ( F = 3.78 , p < 01 ) . No additive benefit result ed from simultaneous exposure to calming music and h and massage . At one hour following any intervention , verbally agitated behavior decreased more than no intervention . Conclusion Calming music and h and massage alter the immediate environment of agitated nursing home residents to a calm structured surrounding , off setting disturbing stimuli , but no additive benefit was found by combining interventions simultaneously We undertook a r and omised controlled trial to assess whether a music therapy ( MT ) scheme of administration , including three working cycles of one month spaced out by one month of no treatment , is effective to reduce behavioural disturbances in severely demented patients . Sixty persons with severe dementia ( 30 in the experimental and 30 in the control group ) were enrolled . Baseline multidimensional assessment included demographics , Mini Mental State Examination ( MMSE ) , Barthel Index and Neuropsychiatry Inventory ( NPI ) for all patients . All the patients of the experimental and control groups received st and ard care ( educational and entertainment activities ) . In addition , the experimental group received three cycles of 12 active MT sessions each , three times a week . Each 30-min session included a group of three patients . Every cycle of treatment was followed by one month of wash-out . At the end of this study , MT treatment result ed to be more effective than st and ard care to reduce behavioural disorders . We observed a significant reduction over time in the NPI global scores in both groups ( F 7,357 = 9.06 , p < 0.001 ) and a significant difference between groups ( F 1,51 = 4.84 , p < 0.05 ) due to a higher reduction of behavioural disturbances in the experimental group at the end of the treatment ( Cohen 's d = 0.63 ) . The analysis of single NPI items shows that delusions , agitation and apathy significantly improved in the experimental , but not in the control group . This study suggests the effectiveness of MT approach with working cycles in reducing behavioural disorders of severely demented patients Background Music therapy ( MT ) has been proposed as valid approach for behavioral and psychologic symptoms ( BPSD ) of dementia . However , studies demonstrating the effectiveness of this approach are lacking . Objective To assess MT effectiveness in reducing BPSD in subjects with dementia . Method Fifty-nine persons with dementia were enrolled in this study . All of them underwent a multidimensional assessment including Mini Mental State Examination , Barthel Index and Neuropsychiatry Inventory at enrolment and after 8 , 16 , and 20 weeks . Subjects were r and omly assigned to experimental ( n=30 ) or control ( n=29 ) group . The MT sessions were evaluated with st and ardized criteria . The experimental group received 30 MT sessions ( 16 wk of treatment ) , whereas the control group received educational support or entertainment activities . Results NPI total score significantly decreased in the experimental group at 8th , 16th , and 20th weeks ( interaction time × group : F3 , 165=5.06 , P=0.002 ) . Specific BPSD ( ie , delusions , agitation , anxiety , apathy , irritability , aberrant motor activity , and night-time disturbances ) significantly improved . The empathetic relationship and the patients ' active participation in the MT approach , also improved in the experimental group . Conclusions The study shows that MT is effective to reduce BPSD in patients with moderate-severe dementia BACKGROUND Agitated behaviours are identified by caregivers as the most challenging in dementia care . Alternative approaches reducing occurrence of agitated behaviours and the need for chemical or physical restraints become valuable for institutionalized elders with dementia . OBJECTIVE AND SETTING This study was to evaluate the effects of group music with movement intervention on occurrence of agitated behaviours of institutionalized elders with dementia in Taiwan . METHODS A r and omized controlled trial was used . Thirty-six institutionalized elders with dementia completed the study , with 18 in the experimental group receiving group music with movement intervention twice a week for 4 weeks and 18 in the control group receiving usual care without intervention . Modified Cohen-Mansfield Agitation Inventory was used to assess agitated behaviours at baseline , weeks 2 and 4 . RESULTS Agitated behaviours were significantly reduced in the experimental group following 4 weeks of group music with movement intervention compared to that of the control group ( p<0.001 ) . CONCLUSIONS Group music with movement intervention can be beneficial in managing agitated behaviours of those with dementia and should be incorporated into care routines in residential facilities OBJECTIVE This experimental study aim ed to evaluate the effects of a group music intervention on anxiety and agitation of institutionalized older adults with dementia . METHODS A total of 60 participants were r and omly assigned to an experimental or a control group . The experimental group received a 30-min music intervention using percussion instruments with familiar music in a group setting in mid afternoon twice weekly for 6 weeks , whereas the control group received usual care with no music intervention . The Rating of Anxiety in Dementia scale was used to assess anxiety , and Cohen-Mansfield Agitation Inventory was used to assess agitation at baseline , week 4 and week 6 . RESULTS Repeated measures analysis of covariance indicated that older adults who received a group music intervention had a significantly lower anxiety score than those in the control group while controlling for pre-test score and cognitive level ( F = 8.98 , p = 0.004 ) . However , the reduction of agitation between two groups was not significantly different . CONCLUSIONS Anxiety and agitation are common in older adults with dementia and have been reported by caregivers as challenging care problems . An innovative group music intervention using percussion instruments with familiar music as a cost-effective approach has the potential to reduce anxiety and improve psychological well-being of those with dementia In a retrospective survey , 487 research projects approved by the Central Oxford Research Ethics Committee between 1984 and 1987 , were studied for evidence of publication bias . As of May , 1990 , 285 of the studies had been analysed by the investigators , and 52 % of these had been published . Studies with statistically significant results were more likely to be published than those finding no difference between the study groups ( adjusted odds ratio [ OR ] 2.32 ; 95 % confidence interval [ Cl ] 1.25 - 4.28 ) . Studies with significant results were also more likely to lead to a greater number of publications and presentations and to be published in journals with a high citation impact factor . An increased likelihood of publication was also associated with a high rating by the investigator of the importance of the study results , and with increasing sample size . The tendency towards publication bias was greater with observational and laboratory-based experimental studies ( OR = 3.79 ; 95 % Cl = 1.47 - 9
Output:
| Music intervention had a medium overall effect on agitation in dementia , suggesting robust clinical relevance .
While the moderate number of studies does not allow for further differentiation between sub-types of music intervention , the sub-group comparisons indicated promising pathways for future systematic review s. This meta- analysis is the first systematic and quantitative overview supporting clinical ly and statistically robust effects of music intervention on agitation in dementia . |
MS212147 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: Publication bias , sometimes known as the " file-drawer problem " or " funnel-plot asymmetry , " is common in empirical research . The authors review the implication s of publication bias for quantitative research synthesis ( meta- analysis ) and describe existing techniques for detecting and correcting it . A new approach is proposed that is suitable for application to meta-analytic data sets that are too small for the application of existing methods . The model estimates parameters relevant to fixed-effects , mixed-effects or r and om-effects meta- analysis contingent on a hypothetical pattern of bias that is fixed independently of the data . The authors illustrate this approach for sensitivity analysis using 3 data sets adapted from a commonly cited reference work on research synthesis ( H. M. Cooper & L. V. Hedges , 1994 ) Impairments of attention and memory are evident in early psychosis , and are associated with functional disability . In a group of stable , medicated women patients , we aim ed to determine whether participating in aerobic exercise or yoga improved cognitive impairments and clinical symptoms . A total of 140 female patients were recruited , and 124 received the allocated intervention in a r and omized controlled study of 12 weeks of yoga or aerobic exercise compared with a waitlist group . The primary outcomes were cognitive functions including memory and attention . Secondary outcome measures were the severity of psychotic and depressive symptoms , and hippocampal volume . Data from 124 patients were included in the final analysis based on the intention-to-treat principle . Both yoga and aerobic exercise groups demonstrated significant improvements in working memory ( P<0.01 ) with moderate to large effect sizes compared with the waitlist control group . The yoga group showed additional benefits in verbal acquisition ( P<0.01 ) and attention ( P=0.01 ) . Both types of exercise improved overall and depressive symptoms ( all P⩽0.01 ) after 12 weeks . Small increases in hippocampal volume were observed in the aerobic exercise group compared with waitlist ( P=0.01 ) . Both types of exercise improved working memory in early psychosis patients , with yoga having a larger effect on verbal acquisition and attention than aerobic exercise . The application of yoga and aerobic exercise as adjunctive treatments for early psychosis merits serious consideration . This study was supported by the Small Research Funding of the University of Hong Kong ( 201007176229 ) , and RGC funding ( C00240/762412 ) by the Authority of Research , Hong Kong IMPORTANCE More effective treatments are needed for negative symptoms of schizophrenia , which are typically chronic , disabling , and costly . Negative symptoms have previously been associated with reduced blood folate levels , especially among patients with low-functioning variants in genes that regulate folate metabolism , suggesting the potential utility of folate supplementation . OBJECTIVES To determine whether folic acid plus vitamin B12 supplementation reduces negative symptoms of schizophrenia and whether functional variants in folate-related genes influence treatment response . DESIGN Parallel-group , r and omized , double-blind , placebo-controlled clinical trial of 16 weeks of treatment with 2 mg of folic acid and 400 μg of vitamin B12 . SETTING Three community mental health centers affiliated with academic medical centers in the United States . PARTICIPANTS Out patients with chronic schizophrenia who were psychiatrically stable but displayed persistent symptoms despite antipsychotic treatment . Eligible patients were 18 to 68 years old , were treated with an antipsychotic agent for 6 months or more at a stable dose for 6 weeks or more , and scored 60 or more on the Positive and Negative Syndrome Scale . INTERVENTION One hundred forty subjects were r and omized to receive daily oral folic acid plus vitamin B12 or placebo . MAIN OUTCOME MEASURES Change in negative symptoms ( Scale for the Assessment of Negative Symptoms [ SANS ] ) , as well as positive and total symptoms ( Positive and Negative Syndrome Scale ) . RESULTS Folate plus vitamin B12 improved negative symptoms significantly compared with placebo ( group difference , -0.33 change in SANS score per week ; 95 % CI , -0.62 to -0.05 ) when genotype was taken into account but not when genotype was excluded . An interaction of the 484C > T variant of FOLH1 ( rs202676 ) with treatment was observed ( P = .02 ) , where only patients homozygous for the 484 T allele demonstrated significantly greater benefit with active treatment ( -0.59 change in SANS score per week ; 95 % CI , -0.99 to -0.18 ) . In parallel , we observed an inverse relationship between red blood cell folate concentration at baseline and 484C allele load ( P = .03 ) , which persisted until 8 weeks of treatment . Change in positive and total symptoms did not differ between treatment groups . CONCLUSIONS Folate plus vitamin B12 supplementation can improve negative symptoms of schizophrenia , but treatment response is influenced by genetic variation in folate absorption . These findings support a personalized medicine approach for the treatment of negative symptoms . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00611806 Varenicline , alpha4beta2 nicotinic acetylcholine receptor ( nAChR ) partial agonist , is a new class of medications for treating nicotine dependence . As an alpha4beta2 nAChR partial agonist , varenicline serves to reduce nicotine withdrawal symptoms , while high-affinity binding of the agonist mitigates the reinforcing effects of smoking . In the present study , we compared serum brain-derived neurotrophic factor ( BDNF ) levels of nicotine dependence and nonsmokers , and we investigated changes in serum BDNF levels after 8 weeks of treatment with varenicline . Patients met the DSM-IV criteria for nicotine dependence . Both the Fagerström test for nicotine dependence ( FTND ) and the Tobacco Dependence Screener ( TDS ) were used . Serum BDNF levels and breath carbon monoxide ( CO ) levels were measured before and 8 weeks after varenicline treatment . Fourteen of 16 subjects ( 87.5 % ) stopped smoking within 12 weeks of varenicline treatment . Thirteen healthy nonsmokers who never had previously smoked were r and omly selected as a control group . Serum BDNF levels of patients before treatment ( 4.8 + /- 3.8 ng/ml ) were significantly lower than those in the control group ( 12.4 + /- 6.13 ng/ml ) . Serum BDNF levels had not increased from baseline ( 4.8 + /- 3.8 ng/ml ) to 8 weeks after varenicline treatment ( 3.0 + /- 1.1 ng/ml ) of patients . These results suggest that smoking might decrease serum BDNF levels and that treatment with varenicline for 8 weeks , combined with 12 weeks of not smoking , does not increase serum BDNF levels in smokers OBJECTIVE To examine the effects of Hatha yoga therapy on resilience , brain-derived neurotrophic factor ( BDNF ) levels , and salivary alpha amylase ( SAA ) activity in patients with schizophrenia-spectrum disorders . DESIGN AND PARTICIPANTS Single-blinded , r and omized controlled study in which out patients with schizophrenia or related psychotic disorders ( according to International Classification of Diseases , 10th Revision ) were r and omly assigned to a yoga or a control group . SETTING November 2012-April 2013 at Yamanashi Prefectural Kita Hospital , Japan . INTERVENTIONS In the yoga group , patients received weekly 1-hour Hatha yoga sessions , in addition to regular treatment , for 8 weeks . Those in the control group underwent regular treatment , which included a daycare rehabilitation program . OUTCOME MEASURES Assessment s included the 25-item Resilience Scale ( RS ) , Positive and Negative Syndrome Scale ( PANSS ) , plasma and salivary BDNF level , and SAA activity . RESULTS Fifty patients participated ( 25 in each group ; mean age±st and ard deviation , 50.9±11.3 years ; mean duration of illness , 25.0±10.3 years ; mean total PANSS score , 78.2±17.3 ) . No significant differences in changes in any variable from baseline to week 8 were found between the two groups ( changes in the yoga group versus the control group : RS score , -1.6±19.9 versus 0.3±17.2 ; PANSS score , 0.5±12.0 versus 5.0±15.6 ; plasma BDNF , 41.6±377.0 pg/dl versus 73.4±346.0 pg/dl ; SAA , -26.2±72.6 kU/l versus -13.8±68.0 kU/l , respectively ) . CONCLUSIONS Adjunct yoga therapy showed no positive changes in resilience level or stress markers . Duration and intensity of yoga sessions and the focus on patients with chronic illness may explain the negative observations in light of past positive evidence regarding yoga therapy Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of an intervention to be underestimated or overestimated . The Cochrane Collaboration ’s tool for assessing risk of bias aims to make the process clearer and more Objectives : l-Theanine ( & ggr;-glutamylethylamide ) augmentation to antipsychotic therapy ameliorates positive , activation , and anxiety symptoms in schizophrenia and schizoaffective disorder patients . This study examines the association between circulating levels of neurochemical indicators and the beneficial clinical effects of l-theanine augmentation . Methods : Serum levels of neurochemical indicators such as brain-derived neurotrophic factor ( BDNF ) , dehydroepi and rosterone ( DHEA ) , its sulfate ( DHEAS ) , cortisol , cholesterol , and insulin were monitored in 40 schizophrenia and schizoaffective disorder patients during an 8-week , double-blind , r and omized , placebo-controlled trial with l-theanine ( 400 mg/d ) . Multiple regression analysis was applied for search ing association between improvement in symptom scores and changes in circulating levels of neurochemical indicators for an 8-week trial . Results : Regression models among l-theanine-treated patients indicate that circulating levels of BDNF and cortisol-to-DHEAS*100 molar ratio were significantly associated with the beneficial clinical effects of l-theanine augmentation . Variability of serum BDNF levels accounted for 26.2 % of the total variance in reduction of dysphoric mood and 38.2 % in anxiety scores . In addition , the changes in cortisol-to-DHEAS*100 molar ratio accounted for 30 % to 34 % of the variance in activation factor and dysphoric mood scores and for 15.9 % in anxiety scores . Regression models among placebo-treated patients did not reach significant level . Conclusions : These preliminary results indicate that circulating BDNF and cortisol-to-DHEAS*100 molar ratio may be involved in the beneficial clinical effects of l-theanine as augmentation of antipsychotic therapy in schizophrenia and schizoaffective disorder patients There is evidence that major psychiatric discords such as schizophrenia ( SZ ) and bipolar disorder ( BD ) are associated with dysregulation of synaptic plasticity with downstream alterations of neurotrophins . Brain-derived neurotrophic factor ( BDNF ) is the most widely distributed neurotrophin in the central nervous system ( CNS ) , and performs many biological functions such as promoting the survival , differentiation , and plasticity of neurons . Variants in the BDNF gene increase the risk of SZ and bipolar disorder . Chronic administration of drugs used to treat SZ and BD , such as lithium , valproate , quetiapine , clozapine , and olanzapine , increases BDNF expression in rat brain . To examine serum BDNF , three groups of chronically medicated DSM-IV SZ patients , on treatment with clozapine ( n=27 ) , typical ( n=14 ) , and other atypical antipsychotics ( n=19 ) , 30 euthymic BD patients , and 26 healthy control had 5 ml blood sample s collected by venipuncture . Serum BDNF levels were significantly higher in SZ patients ( p<0.001 ) when compared to either controls or euthymic BD patients . Increased BDNF in SZ patients might be related to the course of illness or to treatment variables . Prospect i ve studies are warranted Some pre clinical and postmortem studies suggest that the effects of atypical antipsychotics could be mediated by brain-derived neurotrophic factor ( BDNF ) . Olanzapine is an atypical antipsychotic with shown efficacy in psychosis treatment . The aim of this study was to compare plasma BDNF levels at baseline and after 1 year of olanzapine treatment in 18 drug-naive patients who experienced a first psychotic episode with those of 18 healthy control participants matched by age , sex , and socioeconomic level . Plasma BDNF levels were measured in patients at the index episode and at 1 , 6 , and 12 months of follow-up using an enzyme-linked immunosorbent assay . Symptoms and functioning of patients and controls were assessed with the Positive and Negative Symptom Scale and Global Assessment of Function Scale . BDNF levels of patients at on
Output:
| Despite insufficient evidence to draw a conclusion , our results suggest that use of NPIs as adjunctive treatments , specifically non-exercise interventions , may affect positively serum or plasma BDNF in patients with schizophrenia |
MS212148 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
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Input: The aim of this study was to compare the recruitment patterns and latencies of the scapular muscles , as well as the isokinetic performance of the shoulder rotators in 10 subjects with unilateral impingement syndrome who comprised the impingement group ( IG ) with a control group ( CG ) of 10 asymptomatic subjects . The recruitment patterns and latencies were evaluated by electromyographic activity during arm elevation in the scapular plane . Isokinetic work ratios of the shoulder rotator muscles were used to analyze muscular performance . A 2 x 2 ANOVA detected that muscular performance and recruitment patterns were similar for both groups and sides . However , the ANOVA revealed a significant side and group interaction , indicating that the scapular muscle latencies of the affected shoulder was greater than that of the nonaffected side only for the IG ( p < .001 ) . These findings indicated that subjects with light to moderate impingement syndrome showed late recruitment of the scapular muscles during arm elevation . However , muscular performance of the shoulder rotator muscles was not affected BACKGROUND AND PURPOSE Exercise therapy is a commonly used conservative therapy for long-term subacromial pain . However , there is no consensus regarding what type of exercises and dosage is most effective . The aim of this study was to compare the effect of two exercise programmes : 1 ) high-dosage ( HD ) medical exercise therapy versus 2 ) low-dosage ( LD ) exercise therapy programme for subjects with long-term subacromial pain . METHODS This study used a r and omized , controlled clinical trial with an intention-to-treat analysis . Sixty-one subjects were r and omly assigned by concealment either to an HD medical exercise therapy group ( n = 31 ) or to an LD exercise therapy group ( n = 30 ) . Pain ( visual analogue scale [ VAS ] ) and function ( Shoulder Rating Question naire [ SRQ ] ) were measured at inclusion , at end of treatment and at 6 and 12 months follow-up . RESULTS There were no differences between groups at inclusion ( baseline ) regarding any variables . During the three months treatment period , five subjects ( 8 % ) dropped out , and another seven ( 11 % ) dropped out at one-year follow-up . At the end of treatment , both pain and function had improved significantly in favour of the HD therapy , between-group differences in VAS were -2.7 ( -3.9 to 0.9 ) , and for activity limitations , the between-group differences in the SRQ increased by 24.5 points ( 14.5 - 35.7 ) . The differences between groups were both statistically and clinical ly significant at 6 and 12 months follow-up . CONCLUSION In subjects with long-term subacromial pain syndrome , HD medical exercise therapy is superior to a conventional LD exercise programme . For clinicians to obtain similar positive results with HD medical exercise therapy , factors such as good communication skills , constant close personal supervision during exercise treatment and having from three to five subjects in a group setting are important Background : Dysfunction in the kinetic chain caused by poor scapula stabilization can contribute to shoulder injuries and Shoulder Impingement Syndrome ( SIS ) . The purpose of this study was to compare the effectiveness of two treatment approaches scapular stabilization based exercise therapy and physical therapy in patients with SIS . Methods : The study is a r and omized clinical trial in which 68 patients with SIS were r and omly assigned in two groups of exercise therapy ( ET ) and physical therapy ( PT ) and received 18 sessions of treatment . Pain , shoulders ' range of abduction and external rotation , shoulder protraction , scapular rotation and symmetry as well as postural assessment and Pectoralis minor length were evaluated pre and post intervention . The paired- sample t test and the independent sample t test were applied respectively to determine the differences in each group and between two groups . Results : Our findings indicated significant differences in abduction and external rotation range , improvement of forward shoulder translation and increase in the flexibility of the involved shoulder between the two groups ( respectively ; p=0.024 , p=0.001 , p<0/0001 , p<0/0001 ) . No significant difference was detected in pain reduction between the groups ( p=0.576 ) . Protraction of the shoulder ( p<0.0001 ) , forward head posture ( p<0/0001 ) and mid thoracic curvature ( p<0.0001 ) revealed a significant improvement in the ET group . Apparent changes occurred in scapular rotation and symmetry in both groups but no significant differences were observed between the two groups ( respectively ; p=0.183 , p=0.578 ) . Conclusion : The scapular stabilization based exercise intervention was successful in increasing shoulder range , decreasing forward head and shoulder postures and Pectoralis minor flexibility Abstract Scapula taping is a commonly used adjunctive treatment for shoulder im- pingement pathology . However , this intervention has not previously been subject to formal investigation . A pilot single-blind r and omized controlled trial was conducted to evaluate facilitatory taping as an adjunct to routine physiotherapy management . Twenty-two sub- jects with unilateral shoulder impingement symptoms were r and omized into a taping with routine physiotherapy or a routine physiotherapy only group . The intervention group had scapula taping applied three times per week for the first two weeks of their treatment . All subjects were assessed at baseline , then at 2 and 6 weeks after the commencement of treat- ment . Pain and functional ability were assessed using the Shoulder Pain and Disability In- dex , range of shoulder elevation , and self-reported pain on elevation . At 2 weeks , the taping group demonstrated a strong trend toward reduced pain both on self-reported activity ( SPADI pain subscale mean for taping 27.0 versus 41.5 for control ) and pain during mea- sured abduction ( mean VAS 22.8 for taped , 46.8 for control ) , statistical power being limited by small sample size . No similar trend was evident in the SPADI disability subscale . The magnitude of the differences was reduced at 6-week follow-up . This study provides prelimi- nary evidence for a short-term role for scapula taping as an adjunct to routine physiother- apy in the management of shoulder impingement symptoms but also highlights the need for consideration on a case basis relating to risk factors for skin reaction Background Painful shoulders pose a substantial socioeconomic burden . A prospect i ve cost-of-illness study was performed to assess the costs associated with healthcare use and loss of productivity in patients with shoulder pain in primary health care in Sweden . Methods The study was performed in western Sweden , in a region with 24 000 inhabitants . Data were collected during six months from electronic patient records at three primary healthcare centres in two municipalities . All patients between 20 and 64 years of age who presented with shoulder pain to a general practitioner or a physiotherapist were included . Diagnostic codes were used for selection , and the cases were manually controlled . The cost for sick leave was calculated according to the human capital approach . Sensitivity analysis was used to explore uncertainty in various factors used in the model . Results 204 ( 103 women ) patients , mean age 48 ( SD 11 ) years , were registered . Half of the cases were closed within six weeks , whereas 32 patients ( 16 % ) remained in the system for more than six months . A fifth of the patients were responsible for 91 % of the total costs , and for 44 % of the healthcare costs . The mean healthcare cost per patient was € 326 ( SD 389 ) during six months . Physiotherapy treatments accounted for 60 % . The costs for sick leave contributed to 84 % of the total costs . The mean annual total cost was € 4139 per patient . Estimated costs for secondary care increased the total costs by one third . Conclusions The model applied in this study provides valuable information that can be used in cost evaluations . Costs for secondary care and particularly for sick leave have a major influence on total costs and interventions that can reduce long periods of sick leave are warranted PURPOSE This study aim ed to investigate the effect of elastic taping on kinematics , muscle activity and strength of the scapular region in baseball players with shoulder impingement . SCOPE Seventeen baseball players with shoulder impingement were recruited from three amateur baseball teams . All subjects received both the elastic taping ( Kinesio Tex ) and the placebo taping ( 3 M Micropore tape ) over the lower trapezius muscle . We measured the 3-dimensional scapular motion , electromyographic ( EMG ) activities of the upper and lower trapezius , and the serratus anterior muscles during arm elevation . Strength of the lower trapezius was tested prior to and after each taping application . The results of the analyses of variance ( ANOVA ) with repeated measures showed that the elastic taping significantly increased the scapular posterior tilt at 30 degrees and 60 degrees during arm raising and increased the lower trapezius muscle activity in the 60 - 30 degrees arm lowering phase ( p<0.05 ) in comparison to the placebo taping . CONCLUSIONS The elastic taping result ed in positive changes in scapular motion and muscle performance . The results supported its use as a treatment aid in managing shoulder impingement problems The purpose of this clinical trial is to compare the effectiveness of a scapular-focused treatment with a control therapy in patients with shoulder impingement syndrome . Therefore , a r and omized clinical trial with a blinded assessor was used in 22 patients with shoulder impingement syndrome . The primary outcome measures included self-reported shoulder disability and pain . Next , patients were evaluated regarding scapular positioning and shoulder muscle strength . The scapular-focused treatment included stretching and scapular motor control training . The control therapy included stretching , muscle friction , and eccentric rotator cuff training . Main outcome measures were the shoulder disability question naire , diagnostic tests for shoulder impingement syndrome , clinical tests for scapular positioning , shoulder pain ( visual analog scale ; VAS ) , and muscle strength . A large clinical ly important treatment effect in favor of scapular motor control training was found in self-reported disability ( Cohen ’s d = 0.93 , p = 0.025 ) , and a moderate to large clinical ly important improvement in pain during the Neer test , Hawkins test , and empty can test ( Cohen ’s d 0.76 , 1.04 , and 0.92 , respectively ) . In addition , the experimental group demonstrated a moderate ( Cohen ’s d = 0.67 ) improvement in self-experienced pain at rest ( VAS ) , whereas the control group did not change . The effects were maintained at three months follow-up Shoulder tendon injuries are frequently seen in the presence of abnormal scapular motion , termed scapular dyskinesis . The cause and effect relationship between scapular dyskinesis and shoulder injury has not been directly defined . We developed and used an animal model to examine the initiation and progression of pathological changes in the rotator cuff and biceps tendon . Sixty male Sprague-Dawley rats were r and omized into two groups : nerve transection ( to induce scapular dyskinesis , SD ) or sham nerve transection ( control ) . The animals were euthanized 4 and 8 weeks after surgery . Shoulder function and passive joint mechanics were evaluated over time . Tendon mechanical , histological , organizational , and compositional properties were evaluated at both time points . Gross observation demonstrated alterations in scapular motion , consistent with scapular " winging . " Shoulder function , passive internal range of motion , and tendon mechanical properties were significantly altered . Histology results , consistent with tendon pathology ( rounded cell shape and increased cell density ) , were observed , and protein expression of collagen III and decorin was altered . This study presents a new model of scapular dyskinesis that can rigorously evaluate cause and effect relationships in a controlled manner . Our results identify scapular dyskinesis as a causative mechanical mechanism for shoulder tendon pathology A systematic review of the literature was performed to evaluate the role of exercise in treating rotator cuff impingement and to synthesize a st and ard evidence -based rehabilitation protocol . Eleven r and omized , controlled trials ( level 1 and 2 ) evaluating the effect of exercise in the treatment of impingement were identified . Data regarding demographics , methodology , and outcomes of pain , range of motion , strength , and function were recorded . Individual components of each rehabilitation program were catalogued . Effectiveness was determined by statistical and clinical significance . Although many articles had method ologic concerns , the data demonstrate that exercise has statistically and clinical ly significant effects on pain reduction and improving function , but not on range of motion or strength . Manual therapy augments the effects of exercise , yet supervised exercise was not different than home exercise programs . Information regarding specific components of the exercise programs was synthesized into a gold st and ard rehabilitation protocol for future studies on the nonoperative treatment of rotator cuff impingement OBJECTIVE The study investigated the effectiveness of stretching , strengthening exercises , and the scapular stabilization exercises on the pain , shoulder range of motion ( ROM ) , muscle strength , joint position sense ( JPS ) , scapular dyskinesis and quality of life ( OL ) in the patients with subacromial impingement syndrome ( SIS ) . METHODS 27 women and 13 men , mean age 51 ( 24 - 71 ) years old , were included in this study . All the patients were separated into 2 groups according to simple r and om table . Stretching and strengthening exercises were given to the group I ( n=20 ) and scapular stabilization exercises were added to the group II ( n=20 ) . The pain severity , shoulder ROM , muscle strength , JPS , lateral scapular slide test ( LSST ) , Western Ontario Rotator Cuff ( WORC ) Index were evaluated before and after treatment . Patients completed a 6-week rehabilitation program , three times a week . RESULTS The results showed that all measurements improved statistically in both groups after treatment ( p < 0.05 ) . And the improvements in the muscle strength , JPS and scapular dyskinesia were significantly different in group II ( p < 0.05 ) . CONCLUSION It is suggested that in the treatment
Output:
| In conclusion , in adults with SAPS , scapular focused interventions can improve short-term shoulder pain and function |
MS212149 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: PURPOSE / OBJECTIVES To test the effectiveness of two interventions compared to usual care in decreasing attitudinal barriers to cancer pain management , decreasing pain intensity , and improving functional status and quality of life ( QOL ) . DESIGN R and omized clinical trial . SETTING Six outpatient oncology clinics ( three Veterans Affairs [ VA ] facilities , one county hospital , and one community-based practice in California , and one VA clinic in New Jersey ) Sample : 318 adults with various types of cancer-related pain . METHODS Patients were r and omly assigned to one of three groups : control , st and ardized education , or coaching . Patients in the education and coaching groups viewed a video and received a pamphlet on managing cancer pain . In addition , patients in the coaching group participated in four telephone sessions with an advanced practice nurse interventionist using motivational interviewing techniques to decrease attitudinal barriers to cancer pain management . Question naires were completed at baseline and six weeks after the final telephone calls . Analysis of covariance was used to evaluate for differences in study outcomes among the three groups . MAIN RESEARCH VARIABLES Pain intensity , pain relief , pain interference , attitudinal barriers , functional status , and QOL . FINDINGS Attitudinal barrier scores did not change over time among groups . Patients r and omized to the coaching group reported significant improvement in their ratings of pain-related interference with function , as well as general health , vitality , and mental health . CONCLUSIONS Although additional evaluation is needed , coaching may be a useful strategy to help patients decrease attitudinal barriers toward cancer pain management and to better manage their cancer pain . IMPLICATION S FOR NURSING By using motivational interviewing techniques , advanced practice oncology nurses can help patients develop an appropriate plan of care to decrease pain and other symptoms ABSTRACT Cancer pain management can be improved by overcoming patients ’ attitudinal barriers to reporting pain and using analgesics . A simple cost‐effective barriers intervention design ed to reach a large number of persons with cancer has not yet been tested . Such an intervention should be tested against barriers ’ assessment ‐alone , as well as no‐treatment control . The purpose of this study was to test the efficacy and the cost effectiveness of a tailored barriers intervention ( TBI ) , an educational intervention tailored to participants ’ attitudinal barriers toward reporting pain and using analgesics . This was a r and omized three‐group ( TBI , assessment ‐alone , or control ) trial with measures at baseline and 28 days later conducted at the North Central and Heartl and offices of the Cancer Information Service ( CIS ) , an NCI program that provides information to persons seeking answers to cancer‐related questions . Participants ( 1256 adult CIS callers diagnosed with cancer with moderate to severe pain in the past week ) joined the study and were r and omized . Of these participants , 970 ( 77.23 % ) provided follow‐up data . The TBI consisted of educational messages tailored to each participant ’s attitudinal barriers , delivered orally over the telephone , followed by a printed mailed copy . The outcome measures were attitudinal barriers to pain management , as well as pain outcomes ( duration , severity , and interference with life activities ) . At follow‐up the TBI group had significantly lower attitudinal barriers scores compared to assessment ‐alone and control , but the groups did not differ on the pain outcome variables . TBI and assessment ‐alone had similar cost effectiveness . The TBI needs to be strengthened to achieve reductions in pain severity & NA ; St and ard guidelines for cancer pain treatment routinely recommend training patients to reduce barriers to pain relief , use medications appropriately , and communicate their pain‐related needs . Methods are needed to reduce professional time required while achieving sustained intervention effectiveness . In a multisite , r and omized controlled trial , this study tested a pain training method versus a nutrition control . At six oncology clinics , physicians ( N = 22 ) and nurses ( N = 23 ) enrolled patients ( N = 93 ) who were over 18 years of age , with cancer diagnoses , pain , and a life expectancy of at least 6 months . Pain training and control interventions were matched for material s and method . Patients watched a video followed by about 20 min of manual‐st and ardized training with an oncology nurse focused on review ing the printed material and adapted to individual concerns of patients . A follow‐up phone call after 72 h addressed individualized treatment content and pain communication . Assessment s at baseline , one , three , and 6 months included barriers , the Brief Pain Inventory , opioid use , and physician and nurse ratings of their patients ’ pain . Trained versus control patients reported reduced barriers to pain relief ( P < .001 ) , lower usual pain ( P = .03 ) , and greater opioid use ( P < .001 ) . No pain training patients reported severe pain ( > 6 on a 0–10 scale ) at 1‐month outcomes ( P = .03 ) . Physician and nurse ratings were closer to patients ’ ratings of pain for trained versus nutrition groups ( P = .04 and < .001 , respectively ) . Training efficacy was not modified by patient characteristics . Using video and print material s , with brief individualized training , effectively improved pain management over time for cancer patients of varying diagnostic and demographic groups The purpose of this r and omized controlled study was to assess the effects of a structured pain education program on the pain experience of hospitalized cancer patients . Eligible cancer pain patients were r and omly assigned to either an experimental group ( receiving pain education 10–15 min per day for 5 days , n=15 ) or a st and ard care control group ( n=15 ) . The effects of the intervention on six pain-related variables were evaluated using three instruments . Pain intensity , pain interference with daily life , negative beliefs about opioids , beliefs about endurance of pain , pain catastrophizing ( an individual ’s tendency to focus on and exaggerate the threat value of painful stimuli and negatively evaluate his or her own ability to deal with pain ) , and sense of control over pain were evaluated by the Brief Pain Inventory — Short Form Taiwanese version ( BPI-T ) , Pain and Opioid Analgesic Beliefs Scale — Cancer ( POABS-CA ) , and the Catastrophizing subscale and the sense of control over pain measure from the Coping Strategies Question naire ( CSQ ) . The results indicated that , after completing treatment , patients who had received structured pain education had significantly less pain intensity on average , negative pain beliefs regarding opioids , pain endurance beliefs , and pain catastrophizing than patients in the control group . In addition , patients in the pain education group showed a significant increase in their sense of control over pain . These preliminary results strongly suggest that structured pain education can effectively improve the pain experience of hospitalized cancer patients and should be further implemented clinical ly CONTEXT Published literature has not defined the effectiveness of st and ardized educational tools that can be self-administered in the general oncology population with pain . OBJECTIVES We sought to determine if an educational intervention consisting of a video and /or booklet for adults with cancer pain could improve knowledge and attitudes about cancer pain management , pain levels , pain interference , anxiety , quality of life , and analgesic use . METHODS Eligible participants had advanced cancer , a pain score > /=2 of 10 in the last week , English proficiency , an estimated prognosis of more than one month , and were receiving outpatient cancer treatment at participating hospitals . Participants completed baseline assessment s and then were r and omly allocated to receive a booklet , a video , both , or neither , in addition to st and ard care . Outcome measures at two and four weeks included the Barriers Question naire ( BQ ) , Brief Pain Inventory , Global Quality of Life Scale , and Hospital Anxiety and Depression Scale . Adequacy of analgesia and severity of pain were assessed with the Pain Management Index and a daily pain diary . RESULTS One hundred fifty-eight participants were recruited from 21 sites over 42 months . Baseline mean barriers scores were lower than reported in previous Australian studies at 1.33 ( st and ard deviation : 0.92 ) . Mean average pain and worst pain scores improved significantly in patients receiving both the video and booklet by 1.17 ( st and ard error [ SE ] : 0.51 , P=0.02 ) and 1.12 ( SE : 0.57 , P=0.05 ) , respectively , on a 0 - 10 scale . The addiction subscale of the BQ score was improved by 0.44 ( SE : 0.19 ) for participants receiving any part of the intervention ( P=0.03 ) . CONCLUSION Provision of a video and /or booklet for people with cancer pain was a feasible and effective adjunct to the management of cancer pain PURPOSE / OBJECTIVES To assess the effect of an educational homecare program on pain relief in patients with advanced cancer . DESIGN Quasi-experimental ( pretest post-test , nonequivalent group ) . SETTING Four community-based primary care centers providing social and healthcare services in the Quebec City region of Canada . SAMPLE 80 homecare patients with advanced cancer who were free of cognitive impairment , who presented with pain or were taking analgesics to relieve pain , and who had a life expectancy of six weeks or longer . METHODS The educational intervention included information regarding pain assessment and monitoring using a daily pain diary and the provision of specific recommendations in case of loss of pain control . Pain intensity data were collected prior to the intervention , and re assessment s were made two and four weeks later . Data on beliefs were collected at baseline and two weeks . All data were collected by personal interviews . MAIN RESEARCH VARIABLES Patients beliefs about the use of opioids ; average and maximum pain intensities . FINDINGS Patients beliefs regarding the use of opioids were modified successfully following the educational intervention . Average pain was unaffected in the control group and was reduced significantly in patients who received the educational program . The reduction remained after controlling for patients initial beliefs . Maximum pain decreased significantly over time in both the experimental and control groups . CONCLUSIONS An educational intervention can be effective in improving the monitoring and relief of pain in patients with cancer living at home . IMPLICATION S FOR NURSING Homecare nurses can be trained to effectively administer the educational program during their regular homecare visits The purpose of this r and omized controlled study was to investigate the effect of a pain education program ( PEP ) on pain intensity , patients ' satisfaction with pain treatment , and patient-related barriers to pain management among Turkish patients with cancer . The study was conducted in a sample of 40 patients who were hospitalized for cancer and experiencing pain . The patients were equally r and omized to either a PEP or a control group . The data were collected by means of the McGill Pain Question naire , the Numeric Rating Scale , and the Barrier Question naire-Revised . After the completion of the question naires at the first interview , patients in the PEP group received pain education using a pain educational booklet and an explanatory slide program that discussed the booklet 's content with the patients . Patients in the control group received routine clinical care . The question naires were reapplied to the patients in both groups after 2 , 4 , and 8 weeks . Participation in a PEP was associated with decreased pain intensity scores for " present " and " least pain " during weeks 2 , 4 , and 8 ( p < .05 ) . Similarly , there were significant differences between the groups with respect to weeks 2 , 4 , and 8 satisfaction with pain treatment ( p < .05 ) . At the end of second week , the total BQ-r score decreased significantly in the PEP group from 2.12 to 1.29 compared with 2.30 to 2.28 in the control group ( p < .001 ) . The findings suggest that the PEP decreases pain intensity , improves satisfaction with treatment , and decreases barriers about cancer pain management in cancer patients . Incorparation of PEP into the st and ard of care for cancer patients with pain may improve the quality of pain management AIM OF THE STUDY To investigate the role of district nurses in the care of cancer patients with chronic pain at home , as well as the effects of a Pain Education Programme for patients and their district nurses . The Pain Education Programme consisted of a tailored multi- method approach in which they were educated about pain , instructed how to report pain , and how to contact health care providers . BACKGROUND No educational programs for patients in pain have been studied in out patients nor integrated with the home care provided . DESIGN AND METHODS One hundred and four patients and their 115 district nurses were enrolled in a prospect i ve , longitudinal , r and omized controlled study . The primary outcome of interest was type of care provided by district nurses , satisfaction with the pain treatment , and agreement in estimating patients ' pain intensity . RESULTS Results showed that continuity of care was poor as only 36 % of the district nurses were informed about patients ' pain by hospital nurses . Pain was rarely the reason for referring the patient to district nursing after discharge . Although pain control was not a main reason for district nurses to visit a patient , pain was a subject for discussion in 76 % of visits . Besides discussing the pain problem with patients , district nurses provided only a few pain-relieving interventions . District nurses r and omized to the intervention group significantly better estimated patients ' pain intensity , and were more satisfied about patients ' pain treatment , but no differences were found in their assessment of patients ' pain relief . CONCLUSIONS These findings suggest a significant but moderate effect of the Pain Education Programme , with district nurses only playing a minor role in the treatment of cancer pain CONTEXT In Korea , many health care professionals have shown increased concern about the management of cancer pain . Five years after a pain management guideline was distributed to Korean physicians , the Korean Society of Hospice and Palliative Care evaluated the change in cancer pain management . The period evaluated was between 2001 and 2006 . METHODS We did a prospect i ve , cross-sectional cancer pain survey on the change of the pain prevalence and pain intensity , its impact on daily activities and the adequacy of pain management between 2001 and 2006 . RESULTS Overall , 7565 patients were enrolled from 72 cancer hospitals in the 2001 cancer pain survey and 7245 patients were enrolled from 63 cancer
Output:
| Education intervention reduced the pain of cancer patients .
Therefore , patient education could be considered to be an effective method of cancer pain management . |
MS212150 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: Abstract Variability in patients ' response to interventions in pain and other clinical setting s is large . Many explanations such as trial methods , environment or culture have been proposed , but this paper sets out to show that the main cause of the variability may be r and om chance , and that if trials are small their estimate of magnitude of effect may be incorrect , simply because of the r and om play of chance . This is highly relevant to the questions of ‘ How large do trials have to be for statistical accuracy ? ’ and ‘ How large do trials have to be for their results to be clinical ly valid ? ’ The true underlying control event rate ( CER ) and experimental event rate ( EER ) were determined from single‐dose acute pain analgesic trials in over 5000 patients . Trial group size required to obtain statistically significant and clinical ly relevant ( 0.95 probability of number‐needed‐to‐treat within ±0.5 of its true value ) results were computed using these values . Ten thous and trials using these CER and EER values were simulated using varying group sizes to investigate the variation due to r and om chance alone . Most common analgesics have EERs in the range 0.4–0.6 and CER of about 0.19 . With such efficacy , to have a 90 % chance of obtaining a statistically significant result in the correct direction requires group sizes in the range 30–60 . For clinical relevance nearly 500 patients are required in each group . Only with an extremely effective drug ( EER>0.8 ) will we be reasonably sure of obtaining a clinical ly relevant NNT with commonly used group sizes of around 40 patients per treatment arm . The simulated trials showed substantial variation in CER and EER , with the probability of obtaining the correct values improving as group size increased . We contend that much of the variability in control and experimental event rates is due to r and om chance alone . Single small trials are unlikely to be correct . If we want to be sure of getting correct ( clinical ly relevant ) results in clinical trials we must study more patients . Credible estimates of clinical efficacy are only likely to come from large trials or from pooling multiple trials of conventional ( small ) size CONTEXT R and omized trials with adequate sample size offer an opportunity to assess the safety of new medications in a controlled setting ; however , generalizable data on drug safety reporting are sparse . OBJECTIVE To scrutinize the completeness of safety reporting in r and omized trials . DESIGN , SETTING , AND PATIENTS Survey of safety reporting in 192 r and omized drug trials 7 diverse topics with sample sizes of at least 100 patients and at least 50 patients in a study arm ( N = 130074 patients ) . Trial reports were identified from comprehensive meta-analyses in 7 medical areas . MAIN OUTCOME MEASURES Adequate reporting of specific adverse effects and frequency and reasons for withdrawals due to toxic effects ; article space allocated to safety reporting and predictors of such reporting . RESULTS Severity of clinical adverse effects and laboratory-determined toxicity was adequately defined in only 39 % and 29 % of trial reports , respectively . Only 46 % of trials stated the frequency of specific reasons for discontinuation of study treatment due to toxicity . For these 3 parameters , there was significant heterogeneity in rates of adequate reporting across topics ( P = .003 , P<.001 , and P = .02 , respectively ) . Overall , the median space allocated to safety results was 0.3 page . A similar amount of space was devoted to contributor names and affiliations ( P = .16 ) . On average , the percentage of space devoted to safety in the results section was 9.3 % larger in trials involving dose comparisons than in those that did not ( P<.001 ) and 3.8 % smaller in trials reporting statistically significant results for efficacy outcomes ( P = .047 ) . CONCLUSIONS The quality and quantity of safety reporting vary across medical areas , study design s , and setting s but they are largely inadequate . Current st and ards for safety reporting in r and omized trials should be revised to address this inadequacy We assessed the quality of assessment and reporting of adverse effects in r and omized , double-blind clinical trials of single-dose acetaminophen or ibuprofen compared with placebo in moderate to severe postoperative pain . Reports were identified by systematic search ing of a number of bibliographic data bases ( e.g. , MEDLINE ) . Information on adverse effect assessment , severity and reporting , patient withdrawals , and anesthetic used was extracted . Compliance with former guidelines for adverse effect reporting was noted . Fifty-two studies were included ; two made no mention of adverse effects . No method of assessment was given in 19 studies . Twenty trials failed to report the type of anesthetic used , eight made no mention of patient withdrawals , and nine did not state the severity of reported adverse effects . Only two studies described the method of assessment of adverse effect severity . When all adverse effect data were pooled , significantly more adverse effects were reported with active treatment than with placebo . For individual adverse effects , there was no difference between active ( acetaminophen 1000 mg or ibuprofen 400 mg ) and placebo ; the exception was significantly more somnolence/drowsiness with ibuprofen 400 mg . Ninety percent of trials reporting somnolence/drowsiness with ibuprofen 400 mg were in dental pain . All studies published after 1994 complied with former guidelines for adverse effect reporting . Different methods of assessing adverse effects produce different reported incidence : patient diaries yielded significantly more adverse effects than other forms of assessment . We recommend guidelines for reporting adverse effect information in clinical trials There is controversy about whether the lack of response of some chronic pain to opioid treatment is absolute or relative . It is widely believed that nociceptive pain is responsive to opioids whereas neuropathic pain tends not to be . We have used a method of patient-controlled analgesia ( PCA ) with simultaneous nurse-observer measurement of analgesia , mood , and adverse effects to address these issues . Ten patients with chronic pain were given morphine at two concentrations ( 10 and 30 mg/ml ) by PCA in two separate sessions in a double-blind r and omised crossover study . Before the study a clinical judgment was made as to whether each pain was nociceptive or neuropathic . Seven patients showed good analgesic responses ( more than 70 mm pain relief on a visual-analogue scale ) of pain at rest , two patients poor responses ( less than 30 mm pain relief ) , and one a moderate response with both concentrations ( 30 - 70 mm pain relief ) . The response to morphine was consistent ( greater and faster relief with the higher concentration ) in nine patients . Two patients had pain on movement that responded moderately to low-concentration morphine and well to the higher concentration . All patients with pains judged to be nociceptive showed good analgesic responses compared with half of those with neuropathic pain . There was no evidence that analgesic responses in patients with neuropathic pain were due to changes in mood . This PCA method is a quick and efficient tool to determine the consistency of the analgesic response . Such consistency can guide the clinician as to whether continued or higher-dose opioid treatment will produce good analgesia . An inconsistent response points to the use of other pain-relieving strategies & NA ; The aim of the present study has been to assess the responsiveness of various types of chronic pain to opioids given i.v . and tested against placebo in a double‐blind , r and omized fashion . Pain classified as primary nociceptive was effectively alleviated ( P > 0.001 ) while neuropathic deafferentation pain was not significantly influenced by morphine or equivalent doses of other opioids . Also ‘ idiopathic ’ pain , defined as chronic pain with no or little demonstrable pathology , failed to respond . The results were not related to whether the patients were regular users of narcotic analgesics or not . The outcome of our double‐blind opioid test has proved useful to justify a continued , or discontinued , use of narcotic medication in individual patients . It may also support the indication and choice of invasive stimulation procedures ( spinal cord or brain ) . The results of the study illustrate the misconception of chronic pain as an entity and highlight the importance of recognizing different neurobiological mechanisms and differences in responsiveness to analgesic drugs as well as to non‐pharmacological modes of treatment . The opioid test has thus become a valuable tool in pain analysis and helpful as a guide for further treatment & NA ; A data base of r and omised clinical trials ( RCTs ) in pain research published from 1950 to 1990 was created following an extensive literature search . By applying a refined MEDLINE search strategy from 1966 to 1990 and by h and ‐ search ing more than 1 000 000 pages of a total of 40 biomedical journals published during the period 1950–1990 , more than 8000 RCTs were identified . The RCTs were published in more than 800 journals and over 85 % appeared between 1976 and 1990 . If the trend of the last 15 years persists , a total of more than 15 000 RCTs will be published in pain relief by the year 2000 . A detailed description of methods to ensure efficient use of re sources during the identification , retrieval and management of the information in pain relief and other fields is given . Emphasis is made on the importance of refining MEDLINE search strategies , on the use of volunteers to h and ‐ search journals and on careful monitoring of each of the steps of the process . The potential uses of the data base to guide clinical and research decisions are discussed Abstract Healthy university students and hospital staff taking no medications were surveyed by question naire to obtain data on the occurrence of many symptoms often listed as side effects of drugs
Output:
| Use of any oral opioid produced higher rates of adverse events than did placebo .
Because most trials were short , less than four weeks , and because few titrated the dose , these results have limited applicability to longer-term use of opioids in clinical practice . |
MS212151 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: The role of the spleen in tumor immunology is still controversial in that it can either enhance or suppress the antitumor immune response depending on the tumor-bearing host . To clarify this biphasic effect of the spleen , a clinical evaluation of splenectomy in conjunction with immunotherapy and the host immune status was performed in gastric cancer patients . The effect of splenectomy and immunotherapy in 253 gastric cancer patients enrolled in a prospect i ve r and omized trial ( SIP ) was analyzed using the Cox ’s proportional hazards model in terms of the covariate interaction of the preoperative immunosuppressive acidic protein ( IAP ) level . In patients with high IAP levels ( > 580 μg/ml ) with predicted negative antitumor immune reactions splenectomy improved the prognosis . In patients with lower IAP values , conversely , the preservation of the spleen and immunotherapy demonstrated a significant benefit to survival . The spleen was shown to have a biphasic activity in terms of its antitumor immune response depending on the IAP level of the patient . The effect of immunotherapy is significantly influenced by the activity of spleen cells . The preoperative IAP level is therefore considered to be a possible indicator for the effectiveness of splenectomy and immunotherapy in curatively resected gastric cancer patients The following treatments show promise but are as yet to be established as st and ard . They should be prospect ively evaluated in appropriate clinical research setting s. Patient consent for investigational treatments should be sought and the rationale behind them given ( Refer to the Sect . 6 ‘ ‘ Commentary on investigational treatments ’ ’ for details ) . The following constitute investigational treatments : – Endoscopic submucosal dissection under exp and ed criteria – Laparoscopic gastrectomy – Local tumor resection – Neoadjuvant chemotherapy – Adjuvant chemotherapy using agents other than S-1 – Neoadjuvant chemoradiotherapy – Adjuvant chemoradiotherapy – Debulking surgery To compare the outcomes after D1 gastrectomy with those after modified D2 gastrectomy ( preserving pancreas and spleen ) performed by specialist surgeons for gastric cancer in a large UK NHS Trust . In all , 118 consecutive patients with gastric adenocarcinoma were referred by postcode , to undergo either a D1 gastrectomy ( North Gwent ( RJ ) , n=36 , median age 76 years , 21 m ) or a modified D2 gastrectomy ( South Gwent ( WL ) , n=82 , 70 years , 57 m ) . Operative mortality in the two groups of patients was similar ( D1 8.3 % vs D2 7.3 % , χ2 0.286 , DF 1 , P=0.593 ) . Overall cumulative survival at 5 years was 32 % after D1 gastrectomy compared to 59 % after D2 gastrectomy ( χ2 4.25 , DF 1 , P=0.0392 ) . In patients with stage III cancers , survival was 8 % after D1 , compared with 33 % after D2 gastrectomy ( χ2 6.43 , DF 1 , P=0.0112 ) . In a multivariate analysis , T stage ( hazard ratio 2.339 , 95 % CI 1.683–2.995 , P=0.01 ) , N stage ( hazard ratio 4.026 , 95 % CI 3.536–4.516 , P=0.0001 ) and the extent of lymphadenectomy ( hazard ratio 0.258 , 95 % CI –0.426–0.942 , P=0.0001 ) were independently associated with duration s of survival . In conclusion , modified D2 gastrectomy can improve survival four-fold for patients with stage III gastric cancer , without significantly increasing morbidity and mortality when compared with a D1 gastrectomy BACKGROUND In Japan the surgical approach to treatment of potentially curable gastric cancer , including extended lymphadenectomy , seems in retrospective surveys to give better results than the less radical procedures favoured in Western countries . There has , however , been no evidence from r and omised trials that extended lymphadenectomy ( D2 gastric resection ) confers a survival advantage . This question was addressed in a trial involving thirty-two surgeons in Europe . METHODS In a prospect i ve r and omised controlled trial , D1 resection ( level 1 lymphadenectomy ) was compared with D2 resection ( levels 1 and 2 lymphadenectomy ) . Central r and omisation ( 200 patients in each arm ) followed a staging laparotomy . FINDINGS The D2 group had greater postoperative hospital mortality ( 13 % vs 6.5 % ; p=0.04 [ 95 % Cl 9 - 18 % for D2 , 4 - 11 % for D1 ] and higher overall postoperative morbidity ( 46 % vs 28 % ; p<0.001 ) ; their postoperative stay was also longer . The excess postoperative morbidity and mortality in the D2 group was accounted for by distal pancreaticosplenectomy and splenectomy . In the whole group ( 400 patients ) , survival beyond three years was 30 % in patients whose gastrectomy included en-bloc pancreatico-splenic resection versus 50 % in the remainder . INTERPRETATION D2 gastric resections are followed by higher morbidity and mortality than D1 resections . These disadvantages are consequent upon additional pancreatectomies and distal splenectomies , and in long-term follow-up the higher mortality when the pancreas and spleen are resected may prove to nullify any survival benefit from D2 procedures BACKGROUND / AIMS This study was conducted to clarify the impact of pancreaticosplenectomy on the prognosis of patients with gastric carcinoma . METHODOLOGY Two hundred and seventy-two patients who underwent total gastrectomy with distal pancreatectomy and splenectomy were retrospectively review ed . RESULTS Lymph node metastases at the splenic hilum ( # 10 ) and along the splenic artery ( # 11 ) occurred in 12.4 % and 19.2 % of cases , respectively . The 5-year survival rate of those without metastasis at # 10 was 62.8 % . Once nodal metastasis occurred , the prognosis became very poor ; only 18.2 % in those with a single positive node and 15.4 % of those with two or more positive nodes at this location survived 5 years . Similar trends in survival were observed with respect to nodes at # 11 . When stratified by nodal status as currently determined by microscopic examination , pancreaticosplenectomy saved 4.5 % of patients with positive nodes , but was insufficient in 17.3 % of cases and was not necessary in the 78.2 % of cases who were node negative at these locations . CONCLUSIONS The data indicate that pancreaticosplenectomy can save some patients with positive nodes in these regions ; however , the small survival benefit does not provide a basis for the general application of this highly morbid procedure . To further evaluate these results in a r and omized study , selection of a subset of patients who are likely to have metastasis is the key BACKGROUND Complete surgical ( R0 ) resection remains the only potentially curative intervention for patients with localised gastric cancer . To achieve a curative resection , patients may require complex operations with resection of contiguous organs . The aim of this study was to assess how the extent of surgical resection influenced morbidity , mortality and survival in an aged non-selected population with significant comorbid disease . PATIENTS AND METHODS Data were extracted from the Scottish Audit of Gastric and Oesophageal Cancer ( SAGOC ) , a prospect i ve population -based audit of all oesophageal and gastric cancers in Scotl and between 1997 and 1999 with a minimum of 1-year follow-up . RESULTS A total of 646 patients underwent surgical exploration for gastric cancer . A significantly higher incidence of chest infections ( 18.5 vs 11 % , p < 0.05 ) and anastomotic leaks ( 14.3 vs 2.2 % , p < 0.05 ) were associated with total gastrectomy ( n=168 ) when compared to distal gastrectomy ( n=272 ) resections . A 9.2 % mortality rate and a 60 % 1-year survival were associated with gastric resection alone . Removal of the spleen ( n=131 ) , pancreas ( n=30 ) or liver resection ( n=5 ) was associated with a significantly higher mortality rates , 18.3 , 23.3 and 40 % , respectively ( p < 0.05 ) , and significantly lower 1-year survival rates , 50.9 , 39.1 and 20 % , respectively ( p < 0.05 ) . CONCLUSIONS The risk of more extensive resection is not balanced by improved survival in this population based series . Extending gastric resection to involve contiguous organs should be confined to highly selected cases Extended lymphadenectomy for gastric carcinoma has been associated with high mortality and morbidity rates in several multicentre r and omized trials BACKGROUND Historical data and recent studies show that st and ardised extended ( D2 ) lymphadenectomy leads to better results than st and ardised limited ( D1 ) lymphadenectomy . Based on these findings , the Dutch D1D2 trial , a nationwide prospect ively r and omised clinical trial , was undertaken to compare D2 with D1 lymphadenectomy in patients with resectable primary adenocarcinoma of the stomach . The aim of the study was to assess the effect of D2 compared with D1 surgery on disease recurrence and survival in patients treated with curative intent . METHODS Between August , 1989 , and July , 1993 , patients were entered and r and omised at 80 participating hospitals by means of a telephone call to the central data centre of the trial . The sequence of r and omisation was in blocks of six with stratification for the participating centre . Eligibility criteria were a histologically proven adenocarcinoma of the stomach without evidence of distance metastasis , age younger than 85 years , and adequate physical condition for D1 or D2 lymphadenectomy . Patients were excluded if they had previous or coexisting cancer or had undergone gastrectomy for benign tumours . Strict quality control measures for pathological assessment were implemented and monitored . Analyses were by intention to treat . This study is registered with the NCI trial register , as DUT-KWF-CKVO-8905 , EU-90003 . FINDINGS A total of 1078 patients were entered in the study , of whom 996 were eligible . 711 patients underwent the r and omly assigned treatment with curative intent ( 380 in the D1 group and 331 in the D2 group ) and 285 had palliative treatment . Data were collected prospect ively and all patients were followed up for a median time of 15.2 years ( range 6.9 - 17.9 years ) . Analyses were done for the 711 patients treated with curative intent and were according to the allocated treatment group . Of the 711 patients , 174 ( 25 % ) were alive , all but one without recurrence . Overall 15-year survival was 21 % ( 82 patients ) for the D1 group and 29 % ( 92 patients ) for the D2 group ( p=0.34 ) . Gastric-cancer-related death rate was significantly higher in the D1 group ( 48 % , 182 patients ) compared with the D2 group ( 37 % , 123 patients ) , whereas death due to other diseases was similar in both groups . Local recurrence was 22 % ( 82 patients ) in the D1 group versus 12 % ( 40 patients ) in D2 , and regional recurrence was 19 % ( 73 patients ) in D1 versus 13 % ( 43 patients ) in D2 . Patients who had the D2 procedure had a significantly higher operative mortality rate than those who had D1 ( n=32 [ 10 % ] vs n=15 [ 4 % ] ; 95 % CI for the difference 2 - 9 ; p=0.004 ) , higher complication rate ( n=142 [ 43 % ] vs n=94 [ 25 % ] ; 11 - 25 ; p<0.0001 ) , and higher reoperation rate ( n=59 [ 18 % ] vs n=30 [ 8 % ] ; 5 - 15 ; p=0.00016 ) . INTERPRETATION After a median follow-up of 15 years , D2 lymphadenectomy is associated with lower locoregional recurrence and gastric-cancer-related death rates than D1 surgery . The D2 procedure was also associated with significantly higher postoperative mortality , morbidity , and reoperation rates . Because a safer , spleen-preserving D2 resection technique is currently available in high-volume centres , D2 lymphadenectomy is the recommended surgical approach for patients with resectable ( curable ) gastric cancer . FUNDING Dutch Health Insurance Funds Council and The Netherl and s Cancer Foundation BACKGROUND Resection of the spleen en bloc with the stomach for gastric cancer is still widely performed for a curative resection ( R0 ) , but the presence of the spleen may have a favorable effect on recurrence control and surv
Output:
| Conclusions Preservation of the spleen and pancreas during extended lymphadenectomy for gastric cancer decreases complications with no clear evidence of improvement or detriment to overall survival |
MS212152 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: AIMS To evaluate the impact of β-cell function on the efficacy of lixisenatide , a once-daily pr and ial glucagon-like peptide-1 receptor agonist , in patients with type 2 diabetes ( T2D ) . MATERIAL S AND METHODS In this post hoc analysis , patients from the Phase 3 Get Goal -M and Get Goal -S clinical trials r and omized to lixisenatide 20μg once daily were stratified into quartiles by baseline β-cell function , as measured by the secretory units of islet in transplantation ( SUIT ) index . RESULTS Patients ( N=437 ) were distributed evenly among SUIT index quartiles 1 to 4 ( lowest to highest β-cell function ) . Clinical outcomes improved from baseline across all SUIT quartiles ; mean changes at week 24 were : glycated hemoglobin ( HbA1c ; % [ mmol/mol ] ) , -0.99 ( -10.8 ) , -0.87 ( -9.5 ) , -0.86 ( -9.4 ) , -0.83 ( -9.1 ) ; and postpr and ial plasma glucose ( PPG ; mmol/L ) , -7.9 , -5.6 , -5.5 , -4.3 ( overall effect P<0.0001 ) . Furthermore , postpr and ial glucagon was reduced in all SUIT quartiles , while insulinogenic index improved only in patients with higher baseline SUIT ( overall effect P=0.0286 ) . No severe symptomatic hypoglycemic events were reported . CONCLUSIONS Lixisenatide treatment result ed in reductions in HbA1c and PPG levels across all SUIT quartiles . This suggests that non-insulin-related actions of lixisenatide contribute to improved glycemic control in T2D AIMS To compare the efficacy and safety of once-daily pr and ial lixisenatide with placebo in type 2 diabetes mellitus ( T2DM ) insufficiently controlled by pioglitazone ± metformin . METHODS This r and omized , double-blind study included a 24-week main treatment period and a ≥52-week variable extension period . Patients were r and omized 2 : 1 to receive lixisenatide 20 µg once daily or placebo . The primary endpoint was change in glycated haemoglobin ( HbA1c ) at week 24 . RESULTS In total , 484 patients were r and omized : 323 to lixisenatide ; 161 to placebo . After 24 weeks , lixisenatide once daily significantly improved HbA1c ( -0.56 % vs. placebo ; p < 0.0001 ) and increased the proportion of patients achieving HbA1c < 7 % compared with placebo ( 52.3 % vs. 26.4 % , respectively ; p < 0.0001 ) and significantly improved fasting plasma glucose ( -0.84 mmol/l vs. placebo ; p < 0.0001 ) . There was a small decrease in body weight with lixisenatide once daily and a small increase with placebo , with no statistically significant difference between the two groups . Overall , lixisenatide once daily was well tolerated , with a similar proportion of treatment-emergent adverse events ( TEAEs ) and serious TEAEs between groups ( lixisenatide : 72.4 % and 2.5 % ; placebo : 72.7 % and 1.9 % ) . Symptomatic hypoglycaemia rates were also relatively low in both groups ( lixisenatide 3.4 % and placebo 1.2 % ) , with no severe episodes . Lixisenatide continued to be efficacious and well tolerated during the variable extension period . CONCLUSIONS Lixisenatide once daily significantly improved glycaemic control with a low risk of hypoglycaemia , and was well tolerated over 24 weeks and during the long-term , double-blind extension period in patients with T2DM insufficiently controlled on pioglitazone ± metformin OBJECTIVE To examine the efficacy and safety of lixisenatide ( 20 μg once daily , administered before the morning or evening meal ) as add-on therapy in patients with type 2 diabetes insufficiently controlled with metformin alone . RESEARCH DESIGN AND METHODS This was a 24-week , r and omized , double-blind , placebo-controlled study in 680 patients with inadequately controlled type 2 diabetes ( HbA1c 7–10 % [ 53−86 mmol/mol ] ) . Patients were r and omized to lixisenatide morning ( n = 255 ) , lixisenatide evening ( n = 255 ) , placebo morning ( n = 85 ) , or placebo evening ( n = 85 ) injections . RESULTS Lixisenatide morning injection significantly reduced mean HbA1c versus combined placebo ( mean change −0.9 % [ 9.8 mmol/mol ] vs. −0.4 % [ 4.4 mmol/mol ] ; least squares [ LS ] mean difference vs. placebo −0.5 % [ 5.5 mmol/mol ] , P < 0.0001 ) . HbA1c was significantly reduced by lixisenatide evening injection ( mean change –0.8 % [ 8.7 mmol/mol ] vs. –0.4 % [ 4.4 mmol/mol ] ; LS mean difference –0.4 % [ 4.4 mmol/mol ] , P < 0.0001 ) . Lixisenatide morning injection significantly reduced 2-h postpr and ial glucose versus morning placebo ( mean change −5.9 vs. −1.4 mmol/L ; LS mean difference −4.5 mmol/L , P < 0.0001 ) . LS mean difference in fasting plasma glucose was significant in both morning ( –0.9 mmol/L , P < 0.0001 ) and evening ( –0.6 mmol/L , P = 0.0046 ) groups versus placebo . Mean body weight decreased to a similar extent in all groups . Rates of adverse events were 69.4 % in both lixisenatide groups and 60.0 % in the placebo group . Rates for nausea and vomiting were 22.7 and 9.4 % for lixisenatide morning and 21.2 and 13.3 % for lixisenatide evening versus 7.6 and 2.9 % for placebo , respectively . Symptomatic hypoglycemia occurred in 6 , 13 , and 1 patient for lixisenatide morning , evening , and placebo , respectively , with no severe episodes . CONCLUSIONS In patients with type 2 diabetes inadequately controlled on metformin , lixisenatide 20 μg once daily administered in the morning or evening significantly improved glycemic control , with a pronounced postpr and ial effect , and was well tolerated Aim Assess the pharmacodynamics of lixisenatide once daily ( QD ) versus liraglutide QD in type 2 diabetes insufficiently controlled on metformin . Methods In this 28-day , r and omized , open-label , parallel-group , multicentre study ( NCT01175473 ) , patients ( mean HbA1c 7.3 % ) received subcutaneous lixisenatide QD ( 10 µg weeks 1–2 , then 20 µg ; n = 77 ) or liraglutide QD ( 0.6 mg week 1 , 1.2 mg week 2 , then 1.8 mg ; n = 71 ) 30 min before breakfast . Primary endpoint was change in postpr and ial plasma glucose ( PPG ) exposure from baseline to day 28 during a breakfast test meal . Results Lixisenatide reduced PPG significantly more than liraglutide [ mean change in AUC0:30–4:30h : −12.6 vs. −4.0 h·mmol/L , respectively ; p < 0.0001 ( 0:30 h = start of meal ) ] . Change in maximum PPG excursion was −3.9 mmol/l vs. −1.4 mmol/l , respectively ( p < 0.0001 ) . More lixisenatide-treated patients achieved 2-h PPG < 7.8 mmol/l ( 69 % vs. 29 % ) . Changes in fasting plasma glucose were greater with liraglutide ( −0.3 vs. −1.3 mmol/l , p < 0.0001 ) . Lixisenatide provided greater decreases in postpr and ial glucagon ( p < 0.05 ) , insulin ( p < 0.0001 ) and C-peptide ( p < 0.0001 ) . Mean HbA1c decreased in both treatment groups ( from 7.2 % to 6.9 % with lixisenatide vs. 7.4 % to 6.9 % with liraglutide ) as did body weight ( −1.6 kg vs. −2.4 kg , respectively ) . Overall incidence of adverse events was lower with lixisenatide ( 55 % ) versus liraglutide ( 65 % ) , with no serious events or hypoglycaemia reported . Conclusions Once daily prebreakfast lixisenatide provided a significantly greater reduction in PPG ( AUC ) during a morning test meal versus prebreakfast liraglutide . Lixisenatide provided significant decreases in postpr and ial insulin , C-peptide ( vs. an increase with liraglutide ) and glucagon , and better gastrointestinal tolerability than liraglutide OBJECTIVE When oral therapy for type 2 diabetes is ineffective , adding basal insulin improves glycemic control . However , when glycated hemoglobin ( HbA1c ) remains elevated because of postpr and ial hyperglycemia , the next therapeutic step is controversial . We examined the efficacy and safety of lixisenatide in patients with HbA1c still elevated after initiation of insulin glargine . RESEARCH DESIGN AND METHODS This double-blind , parallel-group trial enrolled patients with HbA1c 7–10 % despite oral therapy . Insulin glargine was added and systematic ally titrated during a 12-week run-in , after which c and i date s with fasting glucose ≤7.8 mmol/L and HbA1c 7–9 % were r and omized to lixisenatide 20 µg or placebo for 24 weeks while insulin titration continued . The primary end point was HbA1c change after r and omization . RESULTS The r and omized population ( n = 446 ) had mean diabetes duration of 9.2 years , BMI 31.8 kg/m2 , and daily glargine dosage of 44 units . HbA1c had decreased during run-in from 8.6 to 7.6 % ; adding lixisenatide further reduced HbA1c by 0.71 vs. 0.40 % with placebo ( least squares mean difference , –0.32 % ; 95 % CI , –0.46 to –0.17 ; P < 0.0001 ) . More participants attained HbA1c < 7 % with lixisenatide ( 56 vs. 39 % ; P < 0.0001 ) . Lixisenatide reduced plasma glucose 2 h after a st and ardized breakfast ( difference vs. placebo –3.2 mmol/L ; P < 0.0001 ) and had a favorable effect on body weight ( difference vs. placebo –0.89 kg ; P = 0.0012 ) . Nausea , vomiting , and symptomatic hypoglycemia < 3.3 mmol/L were more common with lixisenatide . CONCLUSIONS Adding lixisenatide to insulin glargine improved overall and postpr and ial hyperglycemia and deserves consideration as an alternative to pr and ial insulin for patients not reaching HbA1c goals with recently initiated basal insulin Aims To assess the efficacy and safety of once-daily lixisenatide versus placebo in Asian patients with type 2 diabetes insufficiently controlled on basal insulin ± sulfonylurea . Methods In this 24-week , r and omized , double-blind , placebo-controlled , parallel-group , multicentre study , participants ( mean baseline HbA1c 8.53 % ) from Japan , Republic of Korea , Taiwan and the Philippines received lixisenatide ( n = 154 ) or placebo ( n = 157 ) in a stepwise dose increase to 20 µg once daily . The primary endpoint was HbA1c change from baseline to week 24 . Results Once-daily lixisenatide significantly improved HbA1c versus placebo ( LS mean difference vs. placebo = −0.88 % [ 95%CI= −1.116 , −0.650 ] ; p < 0.0001 ) , and allowed more patients to achieve HbA1c < 7.0 % ( 35.6 vs. 5.2 % ) and ≤6.5 % ( 17.8 vs. 1.3 % ) . Lixisenatide also significantly improved 2-h postpr and ial plasma glucose and glucose excursion , average 7-point self-monitored blood glucose and fasting plasma glucose . Lix
Output:
| Lixisenatide was well tolerated , demonstrating rates of symptomatic hypoglycemia of 0.8 - 42.9 % and a very low rate of severe hypoglycemia ( < 1.5 % ) as well as no increased risk of cardiovascular events .
The most common adverse events were gastrointestinal in nature , mainly transient nausea and vomiting of mild-to-moderate severity .
Lixisenatide effectively lowers HbA1c levels in patients with T2D through a mechanism of action complementary to that of agents that mainly target FPG , with the additional benefit of weight loss . |
MS212153 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: The objective was to carry out a pilot study exploring memory outcome in patients with temporal lobe epilepsy ( TLE ) and low- grade tumour . A prospect i ve study using a competence-related memory assessment was carried out in the Laboratory of Neuropsychology , Epilepsy Center and Neurosurgical Department of the “ C. Besta ” National Neurological Institute in 24 TLE patients undergoing surgical resection for left ( n=12 ) or right ( n=12 ) low- grade tumours and 36 healthy subjects . Patients underwent mesial or lateral temporal lobe lesionectomy . Neuropsychological tests exploring verbal and visual short-term memory , learning , delayed recall and ability to control interference in memory were applied . Before and after surgery , significant verbal impairment was present in left TLE patients compared to controls and right TLE patients , and visual deficits were present in both groups compared to controls . After surgery , there was no significant decrease in mean verbal or visual memory scores related to the operated side . Some memory abilities subserved by the contralateral temporal lobe improved . Postoperative memory scores were related to preoperative scores , side of operation , age and education . In patients with TLE and low- grade tumour , temporal lobe surgery does not necessarily induce memory deficits . Improvement of memory abilities subserved by the unoperated temporal lobe may be expected BACKGROUND Although manic episodes reportedly contribute to cognitive deficits in bipolar I disorder , the contribution of depressive episodes is poorly research ed . AIMS We investigated the impact of depressive episodes on cognitive function early in the course of bipolar I disorder . METHOD A total of 68 patients and 38 controls from the Systematic Treatment Optimization Programme for Early Mania ( STOP-EM ) first-episode mania programme were examined . We conducted ( a ) a cross-sectional analysis of the impact of prior depressive episodes on baseline cognitive function and ( b ) a prospect i ve analysis assessing the contribution of depression recurrence within 1 year following a first episode of mania on cognitive functioning . RESULTS The cross-sectional analysis showed no significant differences between patients with past depressive episodes compared with those without , on overall or individual domains of cognitive function ( all P>0.09 ) . The prospect i ve analysis failed to reveal a significant group × time interaction for cognitive decline from baseline to 1 year ( P = 0.99 ) in patients with a recurrence of depressive episodes compared with those with no recurrence . However , impaired verbal memory at baseline was associated with a depression recurrence within 1 year . CONCLUSIONS Although deficits in all domains of cognitive function are seen in patients early in the course of bipolar disorder , depressive episodes do not confer additional burden on cognitive function . However , poorer verbal memory may serve as a marker for increased susceptibility to depression recurrence early in the course of illness Volumetric MRI studies based on manual labeling of selected anatomical structures have provided in vivo evidence that brain abnormalities associated with temporal lobe epilepsy ( TLE ) extend beyond the hippocampus . Voxel-based morphometry ( VBM ) is a fully automated image analysis technique allowing identification of regional differences in gray matter ( GM ) and white matter ( WM ) between groups of subjects without a prior region of interest . The purpose of this study was to determine whole-brain GM and WM changes in TLE and to investigate the relationship between these abnormalities and clinical parameters . We studied 85 patients with pharmacologically intractable TLE and unilateral hippocampal atrophy and 47 age- and sex-matched healthy control subjects . The seizure focus was right sided in 40 patients and left sided in 45 . Student 's t test statistical maps of differences between patients ' and controls ' GM and WM concentrations were obtained using a general linear model . A further regression against duration of epilepsy , age of onset , presence of febrile convulsions , and secondary generalized seizures was performed with the TLE population . Voxel-based morphometry revealed that GM pathology in TLE extends beyond the hippocampus involving other limbic areas such as the cingulum and the thalamus , as well as extralimbic areas , particularly the frontal lobe . White matter reduction was found only ipsilateral to the seizure focus , including the temporopolar , entorhinal , and perirhinal areas . This pattern of structural changes is suggestive of disconnection involving preferentially frontolimbic pathways in patients with pharmacologically intractable TLE PURPOSE We previously showed a reduction in the volume of the entorhinal cortex ( EC ) ipsilateral to the seizure focus in patients with intractable temporal lobe epilepsy ( TLE ) . The purpose of this study was to examine the specificity of EC atrophy in epilepsy . METHODS We performed volumetric measurement of the EC on high-resolution magnetic resonance imaging ( MRI ) in patients with TLE ( n = 70 ) , extratemporal lobe epilepsy ( ETE ; n = 18 ) , and idiopathic generalized epilepsy ( IGE ; n = 20 ) . EC volumes of epilepsy patients were compared with those of 48 age- and sex-matched normal controls . Within the TLE group , 63 patients were selected prospect ively with hippocampal atrophy ipsilateral to the seizure focus . The remaining seven patients were chosen retrospectively based on normal volumetric MRI of the hippocampus and amygdale , as well as normal histopathologic examination of the resected tissue . RESULTS Compared with normal controls , EC volume was smaller ipsilateral but not contralateral to the seizure focus in patients with TLE ( p < 0.001 ) . No difference in the EC volumes ipsilateral and contralateral to the seizure focus was seen in patients with ETE and IGE compared with normal controls . The individual analysis showed that the EC was atrophic in 73 % of TLE patients with hippocampal atrophy . Three of the seven TLE patients with normal volumetric MRI of the hippocampus and amygdala and normal histopathologic examination had EC atrophy ipsilateral to the seizure focus . In no patient with ETE or IGE was the EC found to be atrophic . CONCLUSIONS EC atrophy ipsilateral to the seizure focus appears to be specific to mesial temporal lobe structural damage associated with TLE OBJECTIVE The goal of the work described here was to evaluate relationships among resection volume , seizure outcome , and cognitive morbidity after temporal lobectomy for intractable epilepsy . METHODS Thirty patients with mesial temporal sclerosis were evaluated pre- and postoperatively with the Wechsler Adult Intelligence Scale III , Wechsler Memory Scale III , and three-dimensional coronal spoiled gradient recall acquisition MRI . Preoperative whole-brain volumes were calculated with Statistical Parametric Mapping . Resection volume was calculated by manual tracing . Systat was used for statistical analysis . RESULTS All resections included the temporal tip , at least 1 cm of the superior temporal gyrus , and 3 to 5 cm of the middle and inferior temporal gyri . Left were significantly smaller than right temporal resections . Seizure-free patients had significantly larger resections . Immediate verbal memory was significantly worse after left temporal lobectomy . Surgical outcome and resection volume did not affect postoperative neuropsychological results . CONCLUSIONS Dominant temporal lobe resections are associated with immediate verbal memory deficits . Larger resection volume was associated with improved seizure control but not worse cognitive outcome Objective : To assess naming and recognition of faces of familiar famous people in patients with epilepsy before and after anterior temporal lobectomy ( ATL ) . Methods : Color photographs of famous people were presented for naming and description to 63 patients with temporal lobe epilepsy ( TLE ) either before or after ATL and to 10 healthy age- and education-matched controls . Results : Spontaneous naming of photographed famous people was impaired in all patient groups , but was most abnormal in patients who had undergone left ATL . When allowed to demonstrate knowledge of the famous faces through verbal descriptions , rather than naming , patients with left TLE , left ATL , and right TLE improved to normal levels , but patients with right ATL were still impaired , suggesting a new deficit in identifying famous faces . Naming of famous people was related to naming of other common objects , verbal memory , and perceptual discrimination of faces . Recognition of the identity of pictured famous people was more related to visuospatial perception and memory . Conclusions : Lesions in anterior regions of the right temporal lobe impair recognition of the identities of familiar faces , as well as the learning of new faces . Lesions in the left temporal lobe , especially in anterior regions , disrupt access to the names of known people , but do not affect recognition of the identities of famous faces . Results are consistent with the hypothesized role of lateralized anterior temporal lobe structures in facial recognition and naming of unique entities Two hundred and ninety epilepsy surgery patients completed the Hospital Anxiety and Depression Scale and were assessed on a list learning task preoperatively and 1 year postoperatively . Deterioration and improvement in verbal memory were determined using reliable change indices ( RCIs ) at 80 and 90 % confidence limits . Almost one third of patients ( 27 % ) experienced a deterioration in verbal learning . The number of left temporal lobectomy patients who had deteriorated outnumbered the right temporal lobectomy patients by 2:1 . Significant improvements in verbal learning were seen in 21 % of the right temporal lobectomy group and 10 % of the left temporal lobectomy group . Patients who were seizure-free postoperatively were not more likely to experience a postoperative deterioration or improvement in memory than those who continued to experience seizures . No significant relationships were found between subjective ratings of postoperative memory function and objective indices of change . Reliable , objective indices of postoperative deterioration in memory function may bear little relation to the patient 's subjective experience . This should be considered when statistical predictions are used as the basis of preoperative counseling We studied the effects on verbal and nonverbal memory of anterior temporal lobe ( ATL ) surgery for epilepsy in 91 patients ( 46 men , 45 women ) , all of whom had left-hemisphere dominance for speech . Patients were divided into four groups according to sex and laterality of the excision . The memory tasks were administered shortly before surgery , 6 months postoperatively , and at a 2-year follow-up . Test scores were su bmi tted to repeated- measures analyses of variance . We found that men treated with left temporal resection declined significantly in long-delay verbal memory after surgery , whereas no clear pre- to postoperative sex differences were found with respect to other verbal memory scores . Only the results on long-delay verbal memory confirm previous findings , showing a greater vulnerability of verbal memory to left ATL surgery in men than in women . Women with left temporal excisions obtained particularly poor scores on a long-delay nonverbal memory test preoperatively , but improved their performance on this test significantly after surgery . The seemingly gradual improvement during the 2-year follow-up suggests a plastic process A number of studies have shown visuospatial memory deficits following anterior temporal lobectomy ( ATL ) in the right , nondominant temporal lobe ( RATL ) . The current study examines 26 patients with intractable temporal lobe epilepsy who underwent ATL in either the right ( RATL , n = 16 ) or left temporal lobe ( LATL , n = 10 ) on two tests of facial memory abilities , the Wechsler Memory Scale-III ( WMS-III ) Faces subtest and the Graduate Hospital Facial Memory Test ( FMT ) . Repeated measures ANOVA on the FMT indicated a significant main effect of side of surgery . The RATL group performed significantly below the LATL group overall . Both groups showed a slight , but non-significant , improvement in performance from pre- to postsurgery on the FMT immediate memory , likely due to practice effects . Repeated measures ANOVA on the WMS-III Faces subtest revealed a significant interaction of group ( RATL vs. LATL ) by delay ( immediate vs. delayed ) . Overall , the LATL group showed an improvement in recognition scores from immediate to delayed memory , whereas the RATL group performed similarly at both immediate and delayed testing . No effects of surgery were noted on the WMS-III . Following initial data analysis the WMS-III Faces I and II data were re-scored using the scoring suggested by Holdnack and Delis ( 2003 ) , earlier in this issue . Repeated measures ANOVA revealed a trend toward significance in the three-way interaction of group ( RATL vs. LATL ) × time of testing ( pre- versus postop ) × delay ( immediate vs. delayed memory ) . On the Faces I subtest , both the RATL and LATL groups showed a decline from preoperative to postoperative testing . However , on Faces II the LATL group showed an increase in performance from preoperative to postoperative testing , while the RALT group showed a decline in performance from preoperative to postoperative testing . While the FMT appears to be superior to the WMS-III Faces subtest in identifying deficits in facial memory prior to and following RATL , the application of the scoring methodology presented by Holdnack and Delis earlier in this issue does serve to increase the clinical utility of the WMS-III Faces subtest in this population The relationship between preoperative ability levels and postoperative changes in cognitive function was examined among 23 left ( LTL ) and 19 right ( RTL ) temporal lobectomy patients using a battery of memory , language , and visuospatial tasks administered approximately 3 months before surgery and at 6 months follow-up . Higher preoperative performances on the memory and language measures were associated with larger decrements in postsurgical scores among the LTL patients . The RTL group showed no consistent relationship between preoperative ability levels and subsequent postsurgical cognitive changes . Based on the present data , we constructed baserate tables for the Wechsler Memory Scale-Revised indicating the likelihood of measurable gains or
Output:
| RESULTS Deficits in BD-I compared to healthy controls ( HC ) were in executive function , attention span and verbal memory .
Deficits in TLE compared to HC were in executive function and memory .
In the pre- to post-surgical comparisons , verbal memory in left temporal lobe ( LTL ) and , less consistently , visuospatial memory in right temporal lobe ( RTL ) epilepsy declined following surgery .
TLE studies typically examined a narrow range of known temporal lobe-mediated neuropsychological functions , particularly verbal and visuospatial memory .
CONCLUSION Both disorders exhibit deficits in executive function and verbal memory suggestive of both frontal and temporal lobe involvement .
However , deficits in TLE are measured pre- to post-surgery and not controlled at baseline pre-surgery . |
MS212154 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: OBJECTIVES We sought to determine the effects of a community-based , culturally tailored diabetes lifestyle intervention on risk factors for diabetes complications among African Americans and Latinos with type 2 diabetes . METHODS One hundred fifty-one African American and Latino adults with diabetes were recruited from 3 health care systems in Detroit , Michigan , to participate in the Racial and Ethnic Approaches to Community Health ( REACH ) Detroit Partnership diabetes lifestyle intervention . The curriculum , delivered by trained community residents , was aim ed at improving dietary , physical activity , and diabetes self-care behaviors . Baseline and postintervention levels of diabetes-specific quality -of-life , diet , physical activity , self-care knowledge and behaviors , and hemoglobin A1C were assessed . RESULTS There were statistically significant improvements in postintervention dietary knowledge and behaviors and physical activity knowledge . A statistically significant improvement in A1C level was achieved among REACH Detroit program participants ( P<.0001 ) compared with a group of patients with diabetes in the same health care system in which no significant changes were observed ( P=.160 ) . CONCLUSIONS A culturally tailored diabetes lifestyle intervention delivered by trained community residents produced significant improvement in dietary and diabetes self-care related knowledge and behaviors as well as important metabolic improvements Background : The prevalence of type 2 diabetes and diabetesrelated morbidity and mortality is higher among low-income Hispanics when compared to that of Whites . However , little is known about how to effectively promote self-management in this population . Purpose : The objectives were first to determine the feasibility of conducting a r and omized clinical trial of an innovative self-management intervention to improve metabolic control in low-income Spanish-speaking individuals with type 2 diabetes and second to obtain preliminary data of possible intervention effects . Methods : Participants for this pilot study were recruited from a community health center , an elder program , and a community-wide data base developed by the community health center , in collaboration with other agencies serving the community , by surveying households in the entire community . Participants were r and omly assigned to an intervention ( n = 15 ) or a control ( n = 10 ) condition . Assessment s were conducted at baseline and at 3 months and 6 months postr and omization . The intervention consisted of 10 group sessions that targeted diabetes knowledge , attitudes , and self-management skills through culturally specific and literacysensitive strategies . The intervention used a cognitivebehavioral theoretical framework . Results : Recruitment rates at the community health center , elder program , and community registry were 48 % , 69 % , and 8 % , respectively . Completion rates for baseline , 3-month , and 6-month assessment s were 100 % , 92 % , and 92 % , respectively . Each intervention participant attended an average of 7.8 out of 10 sessions , and as a group the participants showed high adherence to intervention activities ( 93 % turned in daily logs , and 80 % self-monitored glucose levels at least daily ) . There was an overall Group × Time interaction ( p = .02 ) indicating group differences in glycosylated hemoglobin over time . The estimated glycosylated hemoglobin decrease at 3 months for the intervention group was −0.8 % ( 95 % confidence intervals = −1.1 % , −0.5 % ) compared with the change in the control group ( p = .02 ) . At 6 months , the decrease in the intervention group remained significant , −0.85 % ( 95 % confidence intervals = −1.2 , −0.5 ) , and the decrease was still significantly different from that of the controls ( p = .005 ) . There was a trend toward increased physical activity in the intervention group as compared to that of the control group ( p = .11 ) and some evidence ( nonsignificant ) of an increase in blood glucose self-monitoring in the intervention participants but not the control participants . Adjusting for baseline depressive scores , we oberved a significant difference in depressive symptoms between intervention participants and control participants at the 3-month assessment ( p = .02 ) . Conclusions : Low-income Spanish-speaking Hispanics are receptive to participate in diabetes-related research . This study shows that the pilot-tested diabetes self-management program is promising and warrants the conduct of a r and omized clinical trial Purpose The purpose of this study was to evaluate the community-based Chronic Disease Self-management Program ( CDSMP ) and the Spanish- language version ( Tom and o Control de Su Salud ) programs as delivered in setting s along the Texas/New Mexico/Mexico border . The programs had proven effective in r and omized trials , and the authors wished to determine if they would be as effective when administered by others to different population s. Methods The El Paso Diabetes Association administered the CDSMP and Tom and o to 445 persons with chronic illness ( two thirds with diabetes ) in Texas , New Mexico , and Mexico . Four-month and 1-year outcomes were compared to baseline using t tests of change scores . Regression models were used to test whether baseline demographics and self-efficacy were associated with positive outcomes of the programs . Results Participants showed improvements in health behaviors , health status , and self-efficacy at both 4 month and 1 year . Baseline self-efficacy and 4-month change in self-efficacy were significantly associated with improved 1- year outcomes . Conclusions The CDSMP and Tom and o are effective when used in setting s other than that of the original study for population s other than those for which they were initially developed PURPOSE Few culturally competent health programs have been design ed for Mexican Americans , a group that bears a disproportionate burden of Type 2 diabetes . In Starr County , a Texas-Mexico border community , investigators design ed and tested a culturally competent intervention aim ed at improving the health of this target population . The purpose of this article is to describe the development process of this diabetes education and support group intervention . METHODS The development stages were ( 1 ) community assessment , ( 2 ) intervention design , ( 3 ) selection or development of outcomes , ( 4 ) pilot testing , and ( 5 ) a r and omized clinical investigation . RESULTS Focus group participants identified knowledge deficits regarding diabetes and self-management strategies , and suggested characteristics of an effective intervention for Mexican Americans . Outcome measures included metabolic control indicators , a newly developed knowledge instrument , and an existing health belief instrument . Preliminary analyses indicated that the intervention was successful in significantly improving metabolic control in the target population . CONCLUSIONS Developing successful diabetes interventions for minority groups requires a number of stages , careful planning , assessment of cultural characteristics of the target population , and a systematic approach to implementation OBJECTIVE The objective of this study was to compare two diabetes self-management interventions design ed for Mexican Americans : " extended " ( 24 h of education , 28 h of support groups ) and " compressed " ( 16 h of education , 6 h of support groups ) . Both interventions were culturally competent regarding language , diet , social emphasis , family participation , and incorporating cultural beliefs . RESEARCH DESIGN AND METHODS We recruited 216 persons between 35 and 70 years of age diagnosed with type 2 diabetes > /=1 year . Intervention groups of eight participants and eight support persons were r and omly assigned to the compressed or extended conditions . The interventions differed in total number of contact hours over the year-long intervention period , with the major difference being the number of support group sessions held . The same information provided in the educational sessions of the extended intervention was compressed into fewer sessions , thus providing more information during each group meeting . RESULTS The interventions were not statistically different in reducing HbA(1c ) ; however , both were effective . A " dosage effect " of attendance was detected with the largest HbA(1c ) reductions achieved by those who attended more of the extended intervention . For individuals who attended > /=50 % of the intervention , baseline to 12-month HbA(1c ) change was -0.6 percentage points for the compressed group and -1.7 percentage points for the extended group . CONCLUSIONS Both culturally competent diabetes self-management education interventions were effective in promoting improved metabolic control and diabetes knowledge . A dosage effect was evident ; attending more sessions result ed in greater improvements in metabolic control OBJECTIVE To determine the effects of a culturally competent diabetes self-management intervention in Mexican Americans with type 2 diabetes . RESEARCH DESIGN AND METHODS A prospect i ve , r and omized , repeated measures study was conducted on the Texas-Mexico border in Starr County . A total of 256 r and omly selected individuals with type 2 diabetes between 35 and 70 years of age , diagnosed with type 2 diabetes after 35 years of age , and accompanied by a family member or friend were included . The intervention consisted of 52 contact hours over 12 months and was provided by bilingual Mexican American nurses , dietitians , and community workers . The intervention involved 3 months of weekly instructional sessions on nutrition , self-monitoring of blood glucose , exercise , and other self-care topics and 6 months of biweekly support group sessions to promote behavior changes . The approach was culturally competent in terms of language , diet , social emphasis , family participation , and incorporation of cultural health beliefs . Outcomes included indicators of metabolic control ( HbA(1c ) and fasting blood glucose ) , diabetes knowledge , and diabetes-related health beliefs . RESULTS Experimental groups showed significantly lower levels of HbA(1c ) and fasting blood glucose at 6 and 12 months and higher diabetes knowledge scores . At 6 months , the mean HbA(1c ) of the experimental subjects was 1.4 % below the mean of the control group ; however , the mean level of the experimental subjects was still high ( > 10 % ) . CONCLUSIONS This study confirms the effectiveness of culturally competent diabetes self-management education on improving health outcomes of Mexican Americans , particularly for those individuals with HbA(1c ) levels > 10 % BACKGROUND Type 2 diabetes affects approximately 8 percent of adults in the United States . Some risk factors -- elevated plasma glucose concentrations in the fasting state and after an oral glucose load , overweight , and a sedentary lifestyle -- are potentially reversible . We hypothesized that modifying these factors with a lifestyle-intervention program or the administration of metformin would prevent or delay the development of diabetes . METHODS We r and omly assigned 3234 nondiabetic persons with elevated fasting and post-load plasma glucose concentrations to placebo , metformin ( 850 mg twice daily ) , or a lifestyle-modification program with the goals of at least a 7 percent weight loss and at least 150 minutes of physical activity per week . The mean age of the participants was 51 years , and the mean body-mass index ( the weight in kilograms divided by the square of the height in meters ) was 34.0 ; 68 percent were women , and 45 percent were members of minority groups . RESULTS The average follow-up was 2.8 years . The incidence of diabetes was 11.0 , 7.8 , and 4.8 cases per 100 person-years in the placebo , metformin , and lifestyle groups , respectively . The lifestyle intervention reduced the incidence by 58 percent ( 95 percent confidence interval , 48 to 66 percent ) and metformin by 31 percent ( 95 percent confidence interval , 17 to 43 percent ) , as compared with placebo ; the lifestyle intervention was significantly more effective than metformin . To prevent one case of diabetes during a period of three years , 6.9 persons would have to participate in the lifestyle-intervention program , and 13.9 would have to receive metformin . CONCLUSIONS Lifestyle changes and treatment with metformin both reduced the incidence of diabetes in persons at high risk . The lifestyle intervention was more effective than metformin Background In light of health disparities and the growing prevalence of chronic disease , there is a need for community-based interventions that improve health behaviors and health status . These interventions should be based on existing theory . Objective This study aim ed to evaluate the health and utilization outcomes of a 6-week community-based program for Spanish speakers with heart disease , lung disease , or type 2 diabetes . Method The treatment participants in this study ( n = 327 ) took a 6-week peer-led program . At 4 months , they were compared with r and omized wait-list control subjects ( n = 224 ) using analyses of covariance . The outcomes for all the treatment participants were assessed at 1 year , as compared with baseline scores ( n = 271 ) using t-tests . Results At 4 months , the participants , as compared with usual-care control subjects , demonstrated improved health status , health behavior , and self-efficacy , as well as fewer emergency room visits ( p < .05 ) . At 1 year , the improvements were maintained and remained significantly different from baseline condition . Conclusions This community-based program has the potential to improve the lives of Hispanics with chronic illness while reducing emergency room use OBJECTIVE To improve clinical diabetes care , patient knowledge , and treatment satisfaction and to reduce health-adverse culture-based beliefs in underserved and underinsured population s with diabetes . RESEARCH DESIGN AND METHODS A total of 153 high-risk patients with diabetes recruited from six community clinic sites in San Diego County , California were enrolled in a nurse case management ( NCM ) and peer education/empowerment group . Baseline and 1-year levels of HbA(1c ) , lipid parameters , systolic and diastolic blood pressure , knowledge of diabetes , culture-based beliefs in ineffective remedies , and treatment satisfaction were prospect ively measured . The NCM and peer education/
Output:
| Interventions were multifaceted with the majority demonstrating significant improvements in clinical outcomes , behavioral outcomes , and diabetes-related knowledge .
Culturally competent interventions have the potential to improve outcomes in Hispanic adults with type 2 diabetes .
However , improvements were modest and attrition was moderate to high in many studies . |
MS212155 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Abstract Makhlouf , I , Castagna , C , Manzi , V , Laurencelle , L , Behm , DG , and Chaouachi , A. Effect of sequencing strength and endurance training in young male soccer players . J Strength Cond Res 30(3 ) : 841–850 , 2016—This study examined the effects of strength and endurance training sequence ( strength before or after endurance ) on relevant fitness variables in youth soccer players . Fifty-seven young elite-level male field soccer players ( 13.7 ± 0.5 years ; 164 ± 8.3 cm ; 53.5 ± 8.6 kg ; body fat ; 15.6 ± 3.9 % ) were r and omly assigned to a control ( n = 14 , CG ) and 3 experimental training groups ( twice a week for 12 weeks ) strength before ( SE , n = 15 ) , after ( ES , n = 14 ) or on alternate days ( ASE , n = 14 ) with endurance training . A significant ( p = 0.001 ) intervention main effect was detected . There were only trivial training sequence differences ( ES vs. SE ) for all variables ( p > 0.05 ) . The CG showed large squat 1 repetition maximum ( 1RM ) and medium sprint , change of direction ability , and jump improvements . ASE demonstrated a trivial difference in endurance performance with ES and SE ( p > 0.05 ) . Large to medium greater improvements for SE and ES were reported compared with ASE for sprinting over 10 and 30 m ( p < 0.02 ) . The SE squat 1RM was higher than in ASE ( moderate , p < 0.02 ) . Postintervention differences between ES and SE with CG fitness variables were small to medium ( p ⩽ 0.05 ) except for a large SE advantage with the Yo-Yo intermittent recovery test ( p < 0.001 , large ) . This study showed no effect of intrasession training sequence on soccer fitness-relevant variables . However , combining strength and endurance within a single training session provided superior results vs. training on alternate days . Concurrent training may be considered as an effective and safe training method for the development of the prospect i ve soccer player Abstract Amaro , NM , Marinho , DA , Marques , MC , Batalha , N , and Morouço , PG . Effects of dry-l and strength and conditioning programs in age group swimmers . J Strength Cond Res 31(9 ) : 2447–2454 , 2017—Even though dry-l and S&C training is a common practice in the context of swimming , there are countless uncertainties over its effects in performance of age group swimmers . The objective was to investigate the effects of dry-l and S&C programs in swimming performance of age group swimmers . A total of 21 male competitive swimmers ( 12.7 ± 0.7 years ) were r and omly assigned to the Control group ( n = 7 ) and experimental groups GR1 and GR2 ( n = 7 for each group ) . Control group performed a 10-week training period of swim training alone , GR1 followed a 6-week dry-l and S&C program based on sets and repetitions plus a 4-week swim training program alone and GR2 followed a 6-week dry-l and S&C program focused on explosiveness , plus a 4-week program of swim training alone . Results for the dry-l and tests showed a time effect between week 0 and week 6 for vertical jump ( p < 0.01 ) in both experimental groups , and for the GR2 ball throwing ( p < 0.01 ) , with moderate to strong effect sizes . The time × group analyses showed that for performance in 50 m , differences were significant , with the GR2 presenting higher improvements than their counterparts ( F = 4.156 ; p = 0.007 ; = 0.316 ) at week 10 . Concluding , the results suggest that 6 weeks of a complementary dry-l and S&C training may lead to improvements in dry-l and strength . Furthermore , a 4-week adaptation period was m and atory to achieve beneficial transfer for aquatic performance . Additional benefits may occur if coaches plan the dry-l and S&C training focusing on explosiveness Purpose To compare the effects of strength training versus ski-ergometer training on double-poling gross efficiency ( GE ) , maximal speed ( Vmax ) , peak oxygen uptake ( $ $ \dot{V}{\text{O } } _ { { 2 { \text{peak}}}}$$V˙O2peak ) for elite male and female junior cross-country skiers . Methods Thirty-three elite junior cross-country skiers completed a 6-week training-intervention period with two additional 40-min training sessions per week . The participants were matched in pairs and within each pair r and omly assigned to either a strength-training group ( STR ) or a ski-ergometer-training group ( ERG ) . Before and after the intervention , the participants completed three treadmill roller-skiing tests to determine GE , Vmax , and $ $ \dot{V}{\text{O } } _ { { 2 { \text{peak}}}}$$V˙O2peak . Mixed between-within subjects analysis of variance ( ANOVA ) was conducted to evaluate differences between and within groups . Paired sample s t tests were used as post hoc tests to investigate within-group differences . Results Both groups improved their Vmax and $ $ \dot{V}{\text{O } } _ { { 2 { \text{peak}}}}$$V˙O2peak expressed absolutely ( all P < 0.01 ) . For the gender-specific sub-groups , it was found that the female skiers in both groups improved both Vmax and $ $ \dot{V}{\text{O } } _ { { 2 { \text{peak}}}}$$V˙O2peak expressed absolutely ( all P < 0.05 ) , whereas the only within-group differences found for the men were improvements of Vmax in the STR group . No between-group differences were found for any of the investigated variables . Conclusions Physiological and performance-related variables of importance for skiers were improved for both training regimes . The results demonstrate that the female skiers ’ physiological adaptations to training , in general , were greater than those of the men . The magnitude of the physiological adaptations was similar for both training regimes Age-related processes in the neuromuscular and the somatosensory system are responsible for decreases in maximal and explosive force production capacity and deficits in postural control . Thus , the objectives of this study were to investigate the effects of resistance training on strength performance and on postural control in seniors . Forty healthy seniors ( 67+/-1 yrs ) participated in this study . Subjects were r and omly assigned to a resistance training ( n=20 ) and a control group ( n=20 ) . Resistance training for the lower extremities lasted for 13 weeks at 80 % of the one repetition maximum . Pre and post tests included the measurement of maximal isometric leg extension force with special emphasis on the early part of the force-time-curve and the assessment of static ( functional reach test ) and dynamic ( t and em walk test , platform perturbation ) postural control . Resistance training result ed in an enhanced strength performance with increases in explosive force exceeding those in maximal strength . Improved performances in the functional reach and in the t and em walk test were observed . Resistance training did not have an effect on the compensation of platform perturbations . Increases in strength performance can primarily be explained by an improved neural drive of the agonist muscles . The inconsistent effect of resistance training on postural control may be explained by heterogeneity of testing methodology or by the incapability of isolated resistance training to improve postural control Abstract .Previous research has reported that plyometric training improves running economy ( RE ) and ultimately distance-running performance , although the exact mechanism by which this occurs remains unclear . This study examined whether changes in running performance result ing from plyometric training were related to alterations in lower leg musculotendinous stiffness ( MTS ) . Seventeen male runners were pre- and post-tested for lower leg MTS , maximum isometric force , rate of force development , 5-bound distance test ( 5BT ) , counter movement jump ( CMJ ) height , RE , V˙O2max , lactate threshold ( Thla ) , and 3-km time . Subjects were r and omly split into an experimental ( E ) group which completed 6 weeks of plyometric training in conjunction with their normal running training , and a control ( C ) group which trained as normal . Following the training period , the E group significantly improved 3-km performance ( 2.7 % ) and RE at each of the tested velocities , while no changes in V˙O2max or Thla were recorded . CMJ height , 5BT , and MTS also increased significantly . No significant changes were observed in any measures for the C group . The results clearly demonstrated that a 6-week plyometric programme led to improvements in 3-km running performance . It is postulated that the increase in MTS result ed in improved RE . We speculate that the improved RE led to changes in 3-km running performance , as there were no corresponding alterations in V˙O2max or Thla Underlying mechanisms of prepubescent strength gains following resistance training are speculative . The purpose of this investigation was to determine the effects of 8 wk of resistance training on muscular strength , integrated EMG amplitude ( IEMG ) , and arm anthropometrics of prepubescent youth . Sixteen subjects ( 8 males , 8 females ) were r and omly assigned to trained or control groups . All subjects ( mean age = 10.3 yr ) were of prepubertal status according to the criteria of Tanner . The trained group performed three sets ( 7 - 11 repetitions ) of bicep curls with dumbbells three times per week for 8 wk . Pre- and posttraining measurements included isotonic and isokinetic strength of the elbow flexors , arm anthropometrics , and IEMG of the biceps brachii . Planned comparisons for a 2 x 2 ( group by test ) ANOVA model were used for data analysis . Significant isotonic ( 22.6 % ) and isokinetic ( 27.8 % ) strength gains were observed in the trained group without corresponding changes in arm circumference or skinfolds . The IEMG amplitude increased 16.8 % ( P < 0.05 ) . The control group did not demonstrate any significant changes in the parameters measured . Early gains in muscular strength result ing from resistance training prepubescent children may be attributed to increased muscle activation PURPOSE Heavy-resistance training and plyometric training offer distinct physiological and neuromuscular adaptations that could enhance running economy and , consequently , distance-running performance . To date , no studies have examined the effect of combining the two modes of training on running economy or performance . METHODS Fifty collegiate male and female cross-country runners performed a 5-km time trial and a series of laboratory-based tests to determine aerobic , anthropometric , biomechanical , and neuromuscular characteristics . Thereafter , each athlete participated in a season of six to eight collegiate cross-country races for 13 wk . After the first 4 wk , athletes were r and omly assigned to either heavy-resistance or plyometric plus heavy-resistance training . Five days after completing their final competition , runners repeated the same set of laboratory tests . We also estimated the effects of the intervention on competition performance throughout the season using athletes of other teams as controls . RESULTS Heavy-resistance training produced small-moderate improvements in peak speed , running economy , and neuromuscular characteristics relative to plyometric resistance training , whereas changes in biomechanical measures favored plyometric resistance training . Men made less gains than women in most tests . Both treatments had possibly harmful effects on competition times in men ( mean = 0.5 % ; 90 % confidence interval = ±1.2 % ) , but there may have been benefit for some individuals . Both treatments were likely beneficial for all women ( -1.2 % ; ±1.3 % ) , but heavy-resistance training was possibly better than plyometric resistance training . CONCLUSIONS The changes in laboratory-based parameters related to distance-running performance were consistent with the changes in competition times for women but only partly for men . Our data indicate that women should include heavy-resistance training in their programs , but men should be cautious about using it in season until more research establishes whether certain men are positive or negative responders OBJECTIVES To compare the impact of short term training with resistance plus plyometric training ( RT+P ) or electromyostimulation plus plyometric training ( EMS+P ) on explosive force production in elite volleyball players . DESIGN Sixteen elite volleyball players of the first German division participated in a training study . METHODS The participants were r and omly assigned to either the RT+P training group ( n=8 ) or the EMS+P training group ( n=8 ) . Both groups participated in a 5-week lower extremity exercise program . Pre and post tests included squat jumps ( SJ ) , countermovement jumps ( CMJ ) , and drop jumps ( DJ ) on a force plate . The three-step reach height ( RH ) was assessed using a custom-made vertec apparatus . Fifteen m straight and lateral sprint ( S15s and S15l ) were assessed using photoelectric cells with interims at 5 m and 10 m. RESULTS RT+P training result ed in significant improvements in SJ ( + 2.3 % ) and RH ( + 0.4 % ) performance . The EMS+P training group showed significant increases in performance of CMJ ( + 3.8 % ) , DJ ( + 6.4 % ) , RH ( + 1.6 % ) , S15l ( -3.8 % ) and after 5 m and 10 m of the S15s ( -2.6 % ; -0.5 % ) . The comparison of training-induced changes between the two intervention groups revealed significant differences for the SJ ( p=0.023 ) in favor of RT+P and for the S15s after 5 m ( p=0.006 ) in favor of EMS+P. CONCLUSIONS The results indicate that RT+P training is effective in promoting jump performances and EMS+P training increases jump , speed and agility performances of elite volleyball players PURPOSE To quantify the effects of a 12
Output:
| Combining training of muscle strength and cardiorespiratory fitness within a training cycle could increase athletic performance more than single-mode training .
However , the physiological effects produced by each training modality could also interfere with each other , improving athletic performance less than single-mode training .
In conclusion , CT is more effective than single-mode ET or ST in improving selected measures of physical fitness and athletic performance in youth .
Specifically , CT compared with ET improved athletic performance in children and particularly adolescents .
Finally , CT was more effective than ST in improving muscle power in youth |
MS212156 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: CONTEXT Although acute renal failure ( ARF ) is believed to be common in the setting of critical illness and is associated with a high risk of death , little is known about its epidemiology and outcome or how these vary in different regions of the world . OBJECTIVES To determine the period prevalence of ARF in intensive care unit ( ICU ) patients in multiple countries ; to characterize differences in etiology , illness severity , and clinical practice ; and to determine the impact of these differences on patient outcomes . DESIGN , SETTING , AND PATIENTS Prospect i ve observational study of ICU patients who either were treated with renal replacement therapy ( RRT ) or fulfilled at least 1 of the predefined criteria for ARF from September 2000 to December 2001 at 54 hospitals in 23 countries . MAIN OUTCOME MEASURES Occurrence of ARF , factors contributing to etiology , illness severity , treatment , need for renal support after hospital discharge , and hospital mortality . RESULTS Of 29 269 critically ill patients admitted during the study period , 1738 ( 5.7 % ; 95 % confidence interval [ CI ] , 5.5%-6.0 % ) had ARF during their ICU stay , including 1260 who were treated with RRT . The most common contributing factor to ARF was septic shock ( 47.5 % ; 95 % CI , 45.2%-49.5 % ) . Approximately 30 % of patients had preadmission renal dysfunction . Overall hospital mortality was 60.3 % ( 95 % CI , 58.0%-62.6 % ) . Dialysis dependence at hospital discharge was 13.8 % ( 95 % CI , 11.2%-16.3 % ) for survivors . Independent risk factors for hospital mortality included use of vasopressors ( odds ratio [ OR ] , 1.95 ; 95 % CI , 1.50 - 2.55 ; P<.001 ) , mechanical ventilation ( OR , 2.11 ; 95 % CI , 1.58 - 2.82 ; P<.001 ) , septic shock ( OR , 1.36 ; 95 % CI , 1.03 - 1.79 ; P = .03 ) , cardiogenic shock ( OR , 1.41 ; 95 % CI , 1.05 - 1.90 ; P = .02 ) , and hepatorenal syndrome ( OR , 1.87 ; 95 % CI , 1.07 - 3.28 ; P = .03 ) . CONCLUSION In this multinational study , the period prevalence of ARF requiring RRT in the ICU was between 5 % and 6 % and was associated with a high hospital mortality rate Objective To evaluate the effect of high-volume hemofiltration ( HVHF ) with lactate-buffered replacement fluids on acid-base balance . Design R and omized crossover study . Setting Intensive Care Unit of Tertiary Medical Center Participants Ten patients with septic shock and acute renal failure . Interventions R and om allocation to 8 h of isovolemic high-volume hemofiltration ( ultrafiltration rate : 6 l/h ) or 8 h of isovolemic continuous venovenous hemofiltration ( ultrafiltration rate : 1 l/h ) with lactate-buffered replacement fluid with subsequent crossover . Measurements and results We measured blood gases , electrolytes , albumin , and lactate concentrations and completed quantitative biophysical analysis of acid-base balance changes . Before high-volume hemofiltration , patients had a slight metabolic alkalosis [ pH : 7.42 ; base excess ( BE ) 2.4 mEq/l ] despite hyperlactatemia ( lactate : 2.51 mmol/l ) . After 2 h of high-volume hemofiltration , the mean lactate concentration increased to 7.30 mmol/l ( p=0.0001 ) . However , a decrease in chloride , strong ion difference effective , and strong ion gap ( SIG ) compensated for the effect of iatrogenic hyperlactatemia so that the pH only decreased to 7.39 ( p=0.05 ) and the BE to −0.15 ( p=0.001 ) . After 6 h , despite persistent hyperlactatemia ( 7 mmol/l ) , the pH had returned to 7.42 and the BE to 2.45 mEq/l . These changes remained essentially stable at 8 h. Similar but less intense changes occurred during continuous venovenous hemofiltration . Conclusions HVHF with lactate-buffered replacement fluids induces iatrogenic hyperlactatemia . However , such hyperlactatemia only has a mild and transient acidifying effect . A decrease in chloride and strong ion difference effective and the removal of unmeasured anions all rapidly compensate for this effect BACKGROUND Acute renal failure is a serious complication in critically ill patients and frequently requires renal replacement therapy , which alters trace element and vitamin metabolism . OBJECTIVE The objective was to study trace element balances during continuous renal replacement therapy ( CRRT ) in intensive care patients . DESIGN In a prospect i ve r and omized crossover trial , patients with acute renal failure received CRRT with either sodium bicarbonate ( Bic ) or sodium lactate ( Lac ) as a buffering agent over 2 consecutive 24-h periods . Copper , selenium , zinc , and thiamine were measured with highly sensitive analytic methods in plasma , replacement solutions , and effluent during 8-h periods . Balances were calculated as the difference between fluids administered and effluent losses and were compared with the recommended intakes ( RI ) from parenteral nutrition . RESULTS Nineteen sessions were conducted in 11 patients aged 65 + /- 10 y. Baseline plasma concentrations of copper were normal , whereas those of selenium and zinc were below reference ranges ; glutathione peroxidase was in the lower range of normal . The replacement solutions contained no detectable copper , 0.01 micromol Se/L ( Bic and Lac ) , and 1.42 ( Bic ) and 0.85 ( Lac ) micromol Zn/L. Micronutrients were detectable in all effluents , and losses were stable in each patient ; no significant differences were found between the Bic and Lac groups . The 24-h balances were negative for selenium ( -0.97 micromol , or 2 times the daily RI ) , copper ( -6.54 micromol , or 0.3 times the daily RI ) , and thiamine ( -4.12 mg , or 1.5 times the RI ) and modestly positive for zinc ( 20.7 micromol , or 0.2 times the RI ) . CONCLUSIONS CRRT results in significant losses and negative balances of selenium , copper , and thiamine , which contribute to low plasma concentrations . Prolonged CRRT is likely to result in selenium and thiamine depletion despite supplementation at recommended amounts UNLABELLED Clinical experience with two physiologic bicarbonate/lactate peritoneal dialysis solutions in automated peritoneal dialysis . BACKGROUND Patients on automated peritoneal dialysis ( APD ) usually receive larger volumes of dialysis solution and more frequent , shorter exchanges than patients on continuous ambulatory peritoneal dialysis ( CAPD ) , and therefore are likely to derive greater benefit from more physiologic solutions . METHODS Peritoneal dialysis solutions containing 25 mmol/L bicarbonate and either 10 or 15 mmol/L lactate were compared with st and ard lactate solutions ( 35 or 40 mmol/L ) in two prospect i ve , open-label studies of patients on APD . Each study included a 2-week baseline period ( lactate solution ) , a 6-week treatment period ( bicarbonate/lactate solution ) , and a 2-week follow-up period ( same lactate solution as baseline ) . Biochemical analyses and assessment s of vital signs and safety parameters were conducted at baseline , every 2 weeks during treatment , and at the end of the follow-up period . A product use question naire was administered in one study at the end of treatment . RESULTS A statistically significant rise in plasma bicarbonate ( approximately 2 mmol/L ) occurred when patients switched from a lactate solution to the bicarbonate/lactate solution with equimolar buffer concentration ( P < 0.001 for each solution ) . Plasma bicarbonate decreased by 1.16 mmol/L after a switch from lactate 40 mmol/L to bicarbonate/lactate 35 mmol/L ( P < 0.001 ) . When patients switched to bicarbonate/lactate 35 , the majority of individual venous plasma bicarbonate values were in the normal range . A switch from a lower calcium ( 1.25 mmol/ L ) lactate solution to a higher calcium ( 1.75 mmol/L ) lactate/bicarbonate solution result ed in a statistically significant rise in serum calcium ( 0.06 mmol/L , P < 0.018 ) . The product use question naire revealed improvements in symptoms , including reduced pain on infusion . CONCLUSION Bicarbonate/lactate solutions may be used safely and effectively in patients on APD . The availability of 2 formulations with different buffer and calcium content provides flexibility for the control of acidosis as well as calcium balance Objective We evaluated the variable Kt/V , which has become established in the therapy of end-stage renal disease in acute renal failure , to assess the influence of the filtration volume of continuous venovenous hemofiltration on Kt/V. We measured the variables of acid-base balance and uremia control . Design Prospect i ve interventional pilot study . Setting Medical intensive care unit of a university hospital . Patients Fifty-six patients with acute renal failure and continuous venovenous hemofiltration treatment . Interventions The patients were consecutively treated with a filtration volume of either 1 L/hr ( group 1 ) or 1.5 L/hr ( group 2 ) . Measurements and Main Results Patients with a filtration volume of 1.5 L/hr achieved a Kt/V of 0.8 per day , which was significantly higher than in the patient group treated with 1 L/hr ( 0.53 , p < .05 ) . The filtration volume of 1.5 L/hr led to a markedly better control of blood urea nitrogen concentrations , 69.3 ± 6.6 mg/dL vs. 52.1 ± 5.2 ( p < .05 ) , and to a much quicker and longer lasting compensation of acidosis . Both groups had acidotic pH at the beginning of therapy ( group 1 , 7.29 ± 0.02 ; group 2 , 7.29 ± 0.02 , nonsignificant ) . In group 2 , a significantly higher pH value than in group 1 was measured after 24 hrs of continuous venovenous hemofiltration ( p < .001 ; 7.39 ± 0.02 vs. 7.31 ± 0.02 ) . The pH values in group 1 did not normalize until after 4 days . The filtration volume of 1.5 L/hr led to a quicker increase in bicarbonate concentrations after 24 hrs of therapy ( group 1 , 2.8 ± 3.2 mmol/L ; group 2 , 6.5 ± 3.1 mmol/L , p < .001 ) . Conclusions The st and ardized urea clearance Kt/V is a valuable tool in the treatment of acute renal failure . Higher Kt/V levels were associated with a better control of uremia and acid-base balance . However , there were no differences in the clinical course , patient survival , percentage of patients with or without renal failure who were transferred from the intensive care unit , or Acute Physiology and Chronic Health Evaluation III scores The characteristics of acetate-free biofiltration ( AFB ) are now well documented in patients with chronic renal failure : hemodynamic tolerance , correction of acid-base imbalance , buffer-free dialysate ( without acetate ) and absence of backfiltration . This hemodialysis technique can be beneficial to patients with acute renal failure ( ARF ) . In our intensive care unit , we prospect ively studied 29 patients with isolated ARF or ARF associated with failure of other organs . All eligible patients were r and omly assigned to undergo dialysis with bicarbonate hemodialysis ( BH ) or with ( AFB ) . All used the same high flux biocompatible dialysis membranes . Effectiveness and hemodynamic tolerance of hemodialysis sessions and evolution of patients were analyzed . Correction of metabolic disorders , although better in the AFB group was not statistically different from that in the BH group . Re-equilibration of acid-base balance was also similar , with or without mechanical ventilation . Heparin consumption was significantly higher in the AFB group , with no effect on haemorrhagic complications . Analysis of hypo- and hypertensive episodes , defined as arterial pressure ( AP ) variations 20 % greater than initial pressure , showed no difference in terms of number or degree of AP variation . However , weight loss and the rate of ultrafiltration led to a higher hypotensive risk in the BH group ( p < 0.05 ) . Finally , the clinical course and prognosis was similar in both groups . In summary , AFB may be considered as effective a hemodialysis technique as BH in patients with ARF . Weight loss was better tolerated in the AFB group and can be a favorable factor considering the deleterious effect of overhydration in patients admitted to an intensive care unit . This
Output:
| There were no significant different between bicarbonate- and lactate-buffered solutions for mortality , serum bicarbonate levels , serum creatinine , serum base excess , serum pH , carbon dioxide partial pressure , central venous pressure and serum electrolytes .
Patients treated with bicarbonate-buffered solutions may experience fewer cardiovascular events , lower serum lactate levels , higher mean arterial pressure and less hypotensive events .
With the exception of mortality , we were not able to assess the main primary outcomes of this review - length of time in ICU , total length of hospital stay and relapse |
MS212157 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: CONTEXT High levels of lipoprotein(a ) are associated with increased risk of myocardial infa rct ion ( MI ) . OBJECTIVE To assess whether genetic data are consistent with this association being causal . DESIGN , SETTING , AND PARTICIPANTS Three studies of white individuals from Copenhagen , Denmark , were used : the Copenhagen City Heart Study ( CCHS ) , a prospect i ve general population study with 16 years of follow-up ( 1991 - 2007 , n = 8637 , 599 MI events ) ; the Copenhagen General Population Study ( CGPS ) , a cross-sectional general population study ( 2003 - 2006 , n = 29 388 , 994 MI events ) ; and the Copenhagen Ischemic Heart Disease Study ( CIHDS ) , a case-control study ( 1991 - 2004 , n = 2461 , 1231 MI events ) . MAIN OUTCOME MEASURES Plasma lipoprotein(a ) levels , lipoprotein(a ) kringle IV type 2 ( KIV-2 ) size polymorphism genotype , and MIs recorded from 1976 through July 2007 for all participants . RESULTS In the CCHS , multivariable-adjusted hazard ratios ( HRs ) for MI for elevated lipoprotein(a ) levels were 1.2 ( 95 % confidence interval [ CI ] , 0.9 - 1.6 ; events/10,000 person-years , 59 ) for levels between the 22nd and 66th percentile , 1.6 ( 95 % CI , 1.1 - 2.2 ; events/10,000 person-years , 75 ) for the 67th to 89th percentile , 1.9 ( 95 % CI , 1.2 - 3.0 ; events/10,000 person-years , 84 ) for the 90th to 95th percentile , and 2.6 ( 95 % CI , 1.6 - 4.1 ; events/10,000 person-years , 108 ) for levels greater than the 95th percentile , respectively , vs levels less than the 22nd percentile ( events/10,000 person-years , 55 ) ( trend P < .001 ) . Numbers of KIV-2 repeats ( sum of repeats on both alleles ) ranged from 6 to 99 and on analysis of variance explained 21 % and 27 % of all variation in plasma lipoprotein(a ) levels in the CCHS and CGPS , respectively . Mean lipoprotein(a ) levels were 56 , 31 , 20 , and 15 mg/dL for the first , second , third , and fourth quartiles of KIV-2 repeats in the CCHS , respectively ( trend P < .001 ) ; corresponding values in the CGPS were 60 , 34 , 22 , and 19 mg/dL ( trend P < .001 ) . In the CCHS , multivariable-adjusted HRs for MI were 1.5 ( 95 % CI , 1.2 - 1.9 ; events/10,000 person-years , 75 ) , 1.3 ( 95 % CI , 1.0 - 1.6 ; events/10,000 person-years , 66 ) , and 1.1 ( 95 % CI , 0.9 - 1.4 ; events/10,000 person-years , 57 ) for individuals in the first , second , and third quartiles , respectively , as compared with individuals in the fourth quartile of KIV-2 repeats ( events/10,000 person-years , 51 ) ( trend P < .001 ) . Corresponding odds ratios were 1.3 ( 95 % CI , 1.1 - 1.5 ) , 1.1 ( 95 % CI , 0.9 - 1.3 ) , and 0.9 ( 95 % CI , 0.8 - 1.1 ) in the CGPS ( trend P = .005 ) , and 1.4 ( 95 % CI , 1.1 - 1.7 ) , 1.2 ( 95 % CI , 1.0 - 1.6 ) , and 1.3 ( 95 % CI , 1.0 - 1.6 ) in the CIHDS ( trend P = .01 ) . Genetically elevated lipoprotein(a ) was associated with an HR of 1.22 ( 95 % CI , 1.09 - 1.37 ) per doubling of lipoprotein(a ) level on instrumental variable analysis , while the corresponding value for plasma lipoprotein(a ) levels on Cox regression was 1.08 ( 95 % CI , 1.03 - 1.12 ) . CONCLUSION These data are consistent with a causal association between elevated lipoprotein(a ) levels and increased risk of MI Background —Oxidized phospholipids ( OxPL ) circulate on apolipoprotein B-100 particles ( OxPL/apoB ) , and primarily on Lp(a ) lipoprotein ( a ) [ Lp(a ) ] . The relationship of OxPL/apoB levels to future cardiovascular events is not known . Methods and Results —The Bruneck study is a prospect i ve population -based survey of 40- to 79-year-old men and women recruited in 1990 . Plasma levels of OxPL/apoB and lipoprotein ( a ) [ Lp(a ) ] were measured in 765 subjects in 1995 and incident cardiovascular disease ( CVD ) , defined as cardiovascular death , myocardial infa rct ion , stroke , and transient ischemic attack , was assessed from 1995 to 2005 . During the follow-up period , 82 subjects developed CVD . In multivariable analysis , which included traditional risk factors , high sensitivity C-reactive protein ( hsCRP ) , and lipoprotein-associated phospholipase A2 ( Lp-PLA2 ) activity , subjects in the highest tertile of OxPL/apoB had a significantly higher risk of cardiovascular events than those in the lowest tertile ( hazard ratio[95 % CI ] 2.4[1.3 to 4.3 ] , P=0.004 ) . The strength of the association between OxPL/apoB and CVD risk was amplified with increasing Lp-PLA2 activity ( P=0.018 for interaction ) . Moreover , OxPL/apoB levels predicted future cardiovascular events beyond the information provided by the Framingham Risk Score ( FRS ) . The effects of OxPL/apoB and Lp(a ) were not independent of each other but they were independent of all other measured risk factors . Conclusions —This study demonstrates that OxPL/apoB levels predict 10-year CVD event rates independently of traditional risk factors , hsCRP , and FRS . Increasing Lp-PLA2 activity further amplifies the risk of CVD mediated by BACKGROUND Oxidized phospholipids on apolipoprotein B-100 ( OxPL-apoB ) is a biomarker of increased risk for major adverse cardiovascular events ( MACE ) in community cohorts , but its role in patients with stable coronary heart disease ( CHD ) is unknown . OBJECTIVES This study sought to examine the relationship between these oxidative biomarkers and cardiovascular outcomes in patients with established CHD . METHODS In a r and om sample from the TNT ( Treating to New Targets ) trial , OxPL-apoB levels were measured in 1,503 patients at r and omization ( after an 8-week run-in period taking atorvastatin 10 mg ) and 1 year after being r and omized to atorvastatin 10 or 80 mg . We examined the association between baseline levels of OxPL-apoB and MACE , defined as death from CHD , nonfatal myocardial infa rct ion , resuscitation after cardiac arrest , and fatal/nonfatal stroke , as well as the effect of statin therapy on OxPL-apoB levels and MACE . RESULTS Patients with events ( n = 156 ) had higher r and omization levels of OxPL-apoB than those without events ( p = 0.025 ) . For the overall cohort , r and omization levels of OxPL-apoB predicted subsequent MACE ( hazard ratio [ HR ] : 1.21 ; 95 % confidence interval : 1.04 to 1.41 ; p = 0.018 ) per doubling and tertile 3 versus tertile 1 ( hazard ratio : 1.69 ; 95 % confidence interval [ CI ] : 1.14 to 2.49 ; p = 0.01 ) after multivariate adjustment for age , sex , body mass index , among others , and treatment assignment . In the atorvastatin 10-mg group , tertile 3 was associated with a higher risk of MACE compared to the first tertile ( HR : 2.08 ; 95 % CI : 1.20 to 3.61 ; p = 0.01 ) but this was not significant in the atorvastatin 80-mg group ( HR : 1.40 ; 95 % CI : 0.80 to 2.46 ; p = 0.24 ) . CONCLUSIONS Elevated OxPL-apoB levels predict secondary MACE in patients with stable CHD , a risk that is mitigated by atorvastatin 80 mg . ( A Study to Determine the Degree of Additional Reduction in CV Risk in Lowering LDL Below Minimum Target Levels [ TNT ] ; NCT00327691 ) OBJECTIVES The aim of this study was to determine the effects of pravastatin and atorvastatin on markers of oxidative stress in plasma . BACKGROUND Hydroxymethylglutaryl coenzyme A reductase inhibitors reduce low-density lipoprotein cholesterol ( LDL-C ) and cardiovascular risk , but their effects on circulating biomarkers of oxidative stress are not well-defined . METHODS Hypercholesterolemic subjects ( n = 120 , ages 21 to 80 years with LDL-C 130 to 220 mg/dl ) were r and omized in a double-blind , parallel design to pravastatin 40 mg/day ( prava40 ) , atorvastatin 10 mg/day ( atorva10 ) , atorvastatin 80 mg/day ( atorva80 ) , or placebo . At baseline and 16 weeks , urinary isoprostanes ( 8 , 12-iso-iPF(2 alpha)-VI isoform ) , plasma lipoprotein-associated phospholipase A2 ( Lp-PLA2 ) , Mercodia oxidized LDL ( OxLDL ) with antibody 4E6 , oxidized phospholipids/apolipoprotein B-100 particle ( OxPL/apoB ) with antibody E06 , immunoglobulin (Ig)G/IgM autoantibodies to malondialdehyde (MDA)-LDL , and apolipoprotein B (apoB)-immune complexes ( IC ) were measured . RESULTS After 16 weeks , there were no significant changes in urinary 8 , 12-iso-iPF(2 alpha)-VI . The Lp-PLA2 and OxLDL were reduced in statin-treated groups , but after adjusting for apoB , only prava40 led to a reduction in Lp-PLA2 ( -15 % , p = 0.008 ) and atorva10 to a decrease in OxLDL ( -12.9 % , p = 0.01 ) . The OxPL/apoB increased 25.8 % ( p < 0.01 ) with prava40 and 20.2 % ( p < 0.05 ) with atorva80 . There were no changes in MDA-LDL autoantibodies , but significant decreases in IC were noted . CONCLUSIONS This study suggests that statin therapy results in variable effects on oxidative stress markers in hypercholesterolemic subjects . Future outcome studies should collectively assess various oxidative markers to define clinical utility BACKGROUND Lipoprotein(a ) ( Lp[a ] ) is a risk factor for cardiovascular disease and calcific aortic valve stenosis . No effective therapies to lower plasma Lp(a ) concentrations exist . We have assessed the safety , pharmacokinetics , and pharmacodynamics of ISIS-APO(a)Rx , a second-generation antisense drug design ed to reduce the synthesis of apolipoprotein(a ) ( apo[a ] ) in the liver . METHODS In this r and omised , double-blind , placebo-controlled , phase 1 study at the PAREXEL Clinical Pharmacology Research Unit ( Harrow , Middlesex , UK ) , we screened for healthy adults aged 18 - 65 years , with a body-mass index less than 32·0 kg/m(2 ) , and Lp(a ) concentration of 25 nmol/L ( 100 mg/L ) or more . Via a r and omisation technique , we r and omly assigned participants to receive a single subcutaneous injection of ISIS-APO(a)Rx ( 50 mg , 100 mg , 200 mg , or 400 mg )
Output:
| This study demonstrates differential changes in OxPL-apoB and Lp(a ) with various lipid-lowering approaches .
These changes in OxPL-apoB and Lp(a ) may provide insights into the results and interpretation of recent cardiovascular disease outcomes trials |
MS212158 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
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***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: PURPOSE Evaluate the effectiveness of body mass index ( BMI ) tables placed in exam rooms as an intervention to encourage providers to calculate and record BMI scores in patients ' medical records . DESIGN In a prospect i ve cohort design , medical record data for 276 adult patients at a federally funded community health center in New Engl and were examined from August 2000 to August 2002 following the intervention . METHODS Prominent , multicolored , laminated BMI tables were posted in the exam rooms of one of the study site 's three primary health care teams . Medical record data collected included documentation of BMI calculation in medical records , documentation of an obesity diagnosis , and inclusion of heights and current weights . Frequency distributions were calculated ; chi-square tests were used to identify associations . FINDINGS In contrast to the comparison teams , patients on the intervention team were more likely to have BMI recorded in the medical record . A statistically significant increase in the diagnosis of obesity was observed throughout the health center after the intervention . CONCLUSIONS Posting BMI tables in exam rooms contributed to increased BMI documentation in patients ' medical records Nursing documentation is an important part of clinical documentation . However , documentation of the nursing process is frequently lacking quality . There are high expectations that computer support in nursing documentation will help improve documentation quality . This study aim ed to examine whether the introduction of a computer based nursing documentation system can improve documentation quality . A prospect i ve intervention study was conducted on 4 wards of the University Medical Center Heidelberg over a period of 18 months . Two wards in the Psychiatric University Medical Center Heidelberg were involved in the research study , as well as a dermatological and a pediatric ward . The results of the study show a significant improvement of documentation quantity and quality on three of the four wards . Positive aspects include completeness of documentation on the nursing process , formal aspects and subjective quality improvement by the nurses . Negative aspects were mainly associated with the contents of the care plans The accuracy of patient records in Swedish nursing homes : congruence of record content and nurses ' and patients ' descriptions . Data from patient records will increasingly be used for care planning , quality assessment , research , health planning and allocation of re sources . Knowledge about the accuracy of such secondary data , however , is limited and only a few studies have been conducted on the accuracy of nursing recording . The aim of this study was to analyse the concordance between the nursing documentation in nursing homes and descriptions of some specific problems of nurses and patients . Comparisons were made between wards where nurses had received training in structured recording based on the nursing process ( study group ) and wards where no intervention had taken place ( reference group ) . Data were collected from the patient records of r and omly selected nursing home residents ( n=85 ) . The methods used were audits of patient records and structured interviews with residents and nurses . The study revealed considerable deficiencies in the accuracy of the patient records when the records were compared with the reports from nurses and residents . The overall agreement between the interview data from nurses and from the patient records was low . Concordance was better in the study group as compared with the reference group in which the recorded data were structured only following chronological order . The study unequivocally demonstrates that there are major limitations in using records as a data source for the evaluation , planning and development of care PURPOSE To evaluate the impact of the quality of nursing diagnoses , interventions , and outcomes in an acute care hospital following the implementation of an educational program . METHOD In a pretest-posttest experimental design study , nurses from 12 wards of a Swiss hospital received an educational intervention -- an introductory class and consecutive classes , using a case discussion method --to implement nursing diagnoses , interventions , and outcomes . Two sets of 36 r and omly selected nursing records were evaluated before and after implementation . The quality of documented nursing diagnoses , interventions , and nursing-sensitive patient outcomes was assessed by 29 Likert-type items with a 0 - 4 scale instrument , called Quality of Nursing Diagnoses , Interventions , and Outcomes ( Q-DIO ) and tested using t-tests . FINDINGS Significant enhancements in the quality of documented nursing diagnoses , interventions , and outcomes were found following the implementation of a planned educational program . CONCLUSIONS The implementation of N AND A , NIC , and NOC ( NNN ) nursing diagnoses , interventions , and outcomes led to higher quality of nursing diagnosis documentation , etiology-specific nursing interventions , and nursing-sensitive patient outcomes . IMPLICATION S FOR NURSING PRACTICE Educational measures support nurses to improve documentation of diagnoses , interventions , and outcomes . The Q-DIO is a useful audit tool A two-month r and omized , controlled trial based on 60 patients has been performed on a ward of the Department of Psychiatry at Heidelberg University Medical Center , Germany , to investigate the influence of computer-based nursing documentation on time investment for documentation , quality of documentation and user acceptance . Time measurements , question naires , documentation analysis and interviews were used to compare patients documented with the computer-based system ( PIK group ) with the control group ( patients documented with the paper-based system ) . The results showed the advantages and disadvantages of computer-based nursing documentation . Time needed for nursing care planning was lower in the PIK group . Some formal aspects of quality were considerably better in the PIK group . On the other h and , time required for documentation of tasks and for report writing was greater in the PIK group . User acceptance increased significantly during the study . The interviews indicated a positive influence of PIK on the cooperation between nurses and physicians The purpose of this study undertaken in an acute care hospital was to evaluate sensitivity and specificity of the documentation of nurse-reported delirium symptoms in medical charts . This is a descriptive study based on the clinical assessment s of a study nurse and nursing notes in the medical charts of 226 delirious older patients newly admitted to an acute care hospital . The results of this prospect i ve validation study indicated that documentation of delirium symptoms is poor . Disorientation , agitation and altered level of consciousness were the three symptoms yielding a higher level of sensitivity , but even so said symptoms were reported in less than a third of the medical charts . Univariate analysis suggested that higher comorbidity level , more severe symptoms of delirium and the use of physical restraints were associated with more valid documentation of delirium symptoms in medical charts . Lastly , this study corroborates results of previous studies , indicating that documentation of delirium symptoms in medical charts can be improved . Future study should target improving nurse documentation of delirium symptoms in medical charts The purpose of this study was to determine how use of a st and ardized nomenclature for nursing diagnosis and intervention statements on the computerized nursing care plan in a long-term care ( LTC ) facility would affect patient outcomes , as well as organizational processes and outcomes . An experimental design was used to compare the effects of two methods of documentation : Computer care plan and paper care plan . Twenty participants ( 10 in each group ) were r and omly assigned to either group . No statistically significant differences were found by group for demographic data . Repeated measures ANOVA was computed for each of the study variables with type of care plan , written or computerized , as the independent variable . There were no statistically significant differences between participants , group ( care plan ) , within subjects ( across time ) , or interaction ( group and time ) effects for the dependent variables : Level of care , activities of daily living , perception of pain , cognitive abilities , number of medications , number of bowel medications , number of constipation episodes , weight , percent of meals eaten , and incidence of alteration in skin integrity . There were significantly more nursing interventions and activities on the computerized care plan , although this care plan took longer to develop at each of the three time periods . Results from this study suggest that use of a computerized plan of care increases the number of documented nursing activities and interventions , but further research is warranted to determine if this potential advantage can be translated into improved patient and organizational outcomes in the long-term care setting PURPOSE To describe pilot testing of Quality of Diagnoses , Interventions and Outcomes ( Q-DIO ) , an instrument to measure quality of nursing documentation . DESIGN Instrument testing was performed using a r and om , stratified sample of 60 nursing documentations representing hospital nursing with and without implementation of st and ardized nursing language ( 30 for both strata ) in a Swiss General Acute Hospital . METHODS Internal consistency and intrarater and interrater reliabilities were tested . Through item analyses , the grade s of difficulty and the discrimination validity of items were evaluated . FINDINGS Internal consistency of nursing diagnoses as process produced Cronbach 's alpha .83 ; nursing diagnoses as product .98 ; nursing interventions .90 ; and nursing-sensitive patient outcomes .99 . With Kappas of .95 , the intrarater and interrater reliabilities were good . Criteria for the grade s of difficulty of items and discrimination validity were well met . The results of this study suggest that Q-DIO is a reliable instrument to measure the documentation quality of nursing diagnoses , interventions , and outcomes . Further testing of Q-DIO in other setting s is recommended AIM This paper is a report of a study to investigate the effect of guided clinical reasoning . This method was chosen as a follow-up educational measure ( refresher ) after initial implementation of st and ardized language . BACKGROUND Research has demonstrated nurses ' need for education in diagnostic reasoning to state and document accurate nursing diagnoses , and to choose effective nursing interventions to attain favourable patient outcomes . METHODS In a cluster r and omized controlled experimental study , nurses from three wards received guided clinical reasoning , an interactive learning method . Three wards , receiving classic case discussion s , functioned as control group . Data were collected in 2004 - 2005 . The quality of 225 r and omly selected nursing records , containing 444 documented nursing diagnoses , corresponding interventions and outcomes was evaluated by applying 18 Likert-type items with a 0 - 4 scale of the instrument Quality of Nursing Diagnoses , Interventions and Outcomes . The effect of guided clinical reasoning was tested against classic case discussion s using T-tests and mixed effects model analyses . FINDINGS The mean scores for nursing diagnoses , interventions and outcomes increased significantly in the intervention group . Guided clinical reasoning led to higher quality of nursing diagnosis documentation ; to aetiology-specific interventions and to enhanced nursing-sensitive patient outcomes . In the control group , the quality was unchanged . CONCLUSION Guided clinical reasoning supported nurses ' abilities to state accurate nursing diagnoses , to select effective nursing interventions and to reach and document favourable patient outcomes . The results support the use of the North American Nursing Diagnosis Association , Nursing Interventions Classification and Nursing Outcomes Classification classifications and demonstrate implication s for the electronic nursing documentation The purpose of this analysis was to evaluate documentation of practice provided by a multidisciplinary team of nurses , physicians , and pharmacists who participated in an educational program on postoperative pain management . Chart audit of 787 patient charts at 6 sites revealed documentation of pain histories in approximately 75 % of the charts , most often in the surgeon 's history and physical examination . Examination of multiple assessment items indicated that the experimental group , relative to the control group , experienced an increase of more than 10 % in the documentation of pain intensity , pain quality , pain duration , numeric rating scale used , pain behavior , factors that increase pain , vital signs , sedation level , cognitive status , social interaction , and mood from before the program to 6 months after the program . Across all sites , documentation of assessment , treatment , and treatment outcome data was infrequent and inconsistent . Calculation of documentation of 4 items that constituted a focused assessment of postoperative pain on the surgical floor revealed a significant program effect for assessment of pain quality and pain intensity . A postprogram survey of participants in the educational program revealed an increase in discussion of postoperative pain management with other practitioners and an increase in use of a 0 to 10 scale to rate pain . More documentation of patient pain history , clinical problems , treatment , and follow-up action is needed to improve practice and research AIM AND OBJECTIVES The aim of this paper is to present a study describing nurses ' adherence to the VIPS model by evaluating the quality of nursing assessment , and the quantity of completed nursing care plans . BACKGROUND Numerous efforts have been made over the years to improve nursing documentation in Denmark . Hospitals have traditionally based nurses ' charting on a rudimentary version of the nursing process and on Virginia Henderson 's theory of human needs . In 2002 - 2004 the Copenhagen University Hospital , Rigshospitalet , introduced the Swedish VIPS model for nursing documentation . VIPS is an acronym for well being , integrity , prevention and safety , all of which are seen as major goals for nursing care . The model organizes nursing data according to a system of keywords , which facilitates storage and retrieval of data . DESIGN AND METHODS The design in this part of the study was retrospective , wherein 50 journals from each of the departments of cardiology , neurology , oncology and urology were audited annually for three years using the Cat-ch-Ing instrument ( n=600 ) . All nursing journals were r and omly selected by including the first 50 journals at each site given a specific date . RESULTS The nursing documentation significantly improved during the course of the study . After the second year the participants used the keywords appropriately and correctly according to the VIPS model . Application of primary nursing increased during the study . Initial , ongoing and discharge patient status improved . The nurses ' familiarity with nursing diagnoses , goals and interventions increased . CONCLUSIONS The structured implementation programme significantly improved nursing documentation , and the simultaneous training of the entire nursing staff shows promise . The VIPS model has prepared the nurses for more complex computerized taxonomies and classification systems in the future by improving the nurses ' analytical skills . Relevance to clinical practice . New strategies for improving nursing documentation have been demonstrated AIM The aim was to implement and evaluate a st and
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| Flaws of nursing documentation were identified and the effects of study interventions on its quality . |
MS212159 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: Summary We investigated the effect of mild hypothermia ( 32–34 ° C ) , mannitol and insulin – induced hypoglycaemia on the ischaemic infa rct volume on permanent middle cerebral artery occlusion with bilateral carotid artery ligation in rats . Temporalis muscle temperature as an indicator of brain temperature was monitored throughout the experiment in all rats , which were r and omly divided into seven groups . During ischaemia , control rats received intravenous saline in a normothermic condition ; treated rats had hypothermia and intravenous saline , hypothermia and mannitol , normothermia and mannitol , normothermia and insulin , normothermia , insulin and glucose , and hypothermia and insulin applied . After the experiment , the animals were killed , and brain sections were stained with haematoxylin and eosin . Images of infa rct areas were determined using a camera attached to the microscope , and analysed by image analysis software . The total volume of infa rct ed tissue , right hemispheric volume , and the percentage of infa rct ion were determined at the end of the image analysis investigation . The infa rct volume on the control group was found to be 128.16±6.67 mm3 . Infa rct volumes in hypothermic groups were significantly smaller than those of the control group ( p<0.05 ) . There were no significant differences between infa rct volumes in the hypothermic groups . However , we found that hypothermia plus mannitol have the greatest neuro-protective effect . In normothermic rats , the infa rct volume decreased proportionally but not statistically ( p>0.05 ) whether mannitol or insulin was given . Our results also demonstrate that pre- , and post-ischaemic serum glucose concentrations influence the volume of infa rct ion . Rats that had had pre-ischaemic high serum glucose concentrations had a higher volume of infa rct than the hypothermic rats ( p<0.05 ) , while rats with post-ischaemic low serum glucose concentrations had a lower volume of infa rct than the control rats BACKGROUND AND PURPOSE Hyperglycemia at the time of ischemic stroke is associated with increased mortality and morbidity . Animal studies suggest that infa rct expansion may be responsible . The influence of persisting hyperglycemia after stroke has not previously been examined . We measured the blood glucose profile after acute ischemic stroke and correlated it with infa rct volume changes using T2- and diffusion-weighted MRI . METHODS We recruited 25 subjects within 24 hours of ischemic stroke symptoms . Continuous glucose monitoring was performed with a glucose monitoring device ( CGMS ) , and 4-hour capillary glucose levels ( BGL ) were measured for 72 hours after admission . MRI and clinical assessment s were performed at acute ( median , 15 hours ) , subacute ( median , 5 days ) , and outcome ( median , 85 days ) time points . RESULTS Mean CGMS glucose and mean BGL glucose correlated with infa rct volume change between acute and subacute diffusion-weighted MRI ( r > or=0.60 , P<0.01 ) , acute and outcome MRI ( r=0.56 , P=0.01 ) , outcome National Institutes of Health Stroke Scale ( NIHSS ; r > or=0.53 , P<0.02 ) , and outcome modified Rankin Scale ( mRS ; r > or=0.53 , P=0.02 ) . Acute and final infa rct volume change and outcome NIHSS and mRS were significantly higher in patients with mean CGMS or mean BGL glucose > or=7 mmol/L. Multiple regression analysis indicated that both mean CGMS and BGL glucose levels > or=7 mmol/L were independently associated with increased final infa rct volume change . CONCLUSIONS Persistent hyperglycemia on serial glucose monitoring is an independent determinant of infa rct expansion and is associated with worse functional outcome . There is an urgent need to study normalization of blood glucose after stroke OBJECTIVES We tested how insulin-glucose infusion followed by multidose insulin treatment in diabetic patients with acute myocardial infa rct ion affected mortality during the subsequent 12 months of follow-up . BACKGROUND Despite significant improvements in acute coronary care , diabetic patients with acute myocardial infa rct ion still have a high mortality rate . METHODS A total of 620 patients were studied : 306 r and omized to treatment with insulin-glucose infusion followed by multidose subcutaneous insulin for > or = 3 months and 314 to conventional therapy . RESULTS The two groups were well matched for baseline characteristics . Blood glucose decreased from 15.4 + /- 4.1 to 9.6 + /- 3.3 mmol/liter ( mean + /- SD ) in the infusion group during the 1st 24 h , and from 15.7 + /- 4.2 to 11.7 + /- 4.1 among control patients ( p < 0.0001 ) . After 1 year 57 subjects ( 18.6 % ) in the infusion group and 82 ( 26.1 % ) in the control group had died ( relative mortality reduction 29 % , p = 0.027 ) . The mortality reduction was particularly evident in patients who had a low cardiovascular risk profile and no previous insulin treatment ( 3-month mortality rate 6.5 % in the infusion group vs. 13.5 % in the control group [ relative reduction 52 % , p = 0.046 ] ; 1-year mortality rate 8.6 % in the infusion group vs. 18.0 % in the control group [ relative reduction 52 % , p = 0.020 ] ) . CONCLUSIONS Insulin-glucose infusion followed by a multidose insulin regimen improved long-term prognosis in diabetic patients with acute myocardial infa rct ion Background —The clinical benefits of insulin previously observed in acute ST-segment – elevation myocardial infa rct ion ( STEMI ) may be partially explained by an anti-inflammatory effect . We assessed this potential effect of insulin in STEMI patients treated with fibrinolytics . Methods and Results —Thirty-two patients receiving reteplase were r and omly assigned infusions of either insulin at 2.5 U/h , dextrose , and potassium ( GIK ) or normal saline and potassium ( C ) for 48 hours . Plasma concentrations of high-sensitivity C-reactive protein ( CRP ) , serum amyloid A ( SAA ) , plasminogen activator inhibitor-1 ( PAI-1 ) , creatine kinase ( CK ) , and CK-MB were measured at baseline and sequentially for 48 hours . Total p47phox protein in mononuclear cells was measured in a subgroup of 13 subjects . Baseline CRP and SAA were significantly increased ( 2- to 4-fold ) at 24 and 48 hours in each group ( P < 0.01 ) . However , in the insulin group , there was a significant ( P < 0.05 ) attenuation of the absolute rise in concentration of CRP and SAA from baseline . The absolute increase of CRP and SAA was reduced by 40 % ( CRP ) and 50 % ( SAA ) at 24 hours and at 48 hours compared with the control group . The absolute increase in PAI-1 from baseline and the percentage increase in p47phox over 48 hours were significantly ( P < 0.05 ) lower in the insulin-treated group . CK-MB peaked earlier and tended to be lower in insulin-treated subjects , especially in patients with inferior MI . Conclusions —Insulin has an anti-inflammatory and profibrinolytic effect in patients with acute MI . These effects may contribute to the clinical benefits of insulin in STEMI Objective : To analyze the frequency , clinical characteristics , and predictors of symptomatic intracerebral hemorrhage ( ICH ) after intraarterial ( IA ) thrombolysis with recombinant pro-urokinase ( r-proUK ) in acute ischemic stroke . Method : The authors conducted an exploratory analysis of symptomatic ICH from a r and omized , controlled clinical trial of IA thrombolysis with r-proUK for patients with angiographically documented occlusion of the middle cerebral artery within 6 hours from stroke onset . Patients ( n = 180 ) were r and omized in a ratio of 2:1 to either 9 mg IA r-proUK over 120 minutes plus IV fixed-dose heparin or IV fixed-dose heparin alone . As opposed to intention to treat , this analysis was based on “ treatment received ” and includes 110 patients given r-proUK and 64 who did not receive any thrombolytic agent . The remaining six patients received out-of- protocol urokinase and were excluded from analysis . The authors analyzed central ly adjudicated ICH with associated neurologic deterioration ( increase in NIH Stroke Scale [ NIHSS ] score of ≥4 points ) within 36 hours of treatment initiation . Results : Symptomatic ICH occurred in 12 of 110 patients ( 10.9 % ) treated with r-proUK and in two of 64 ( 3.1 % ) receiving heparin alone . ICH symptoms in r-proUK – treated patients occurred at a mean of 10.2 ± 7.4 hours after the start of treatment . Mortality after symptomatic ICH was 83 % ( 10/12 patients ) . Only blood glucose was significantly associated with symptomatic ICH in r-proUK – treated patients based on univariate analyses of 24 variables : patients with baseline glucose > 200 mg/dL experienced a 36 % risk of symptomatic ICH compared with 9 % for those with ≤200 mg/dL ( p = 0.022 ; relative risk , 4.2 ; 95 % CI , 1.04 to 11.7 ) . Conclusions : Symptomatic ICH after IA thrombolysis with r-proUK for acute ischemic stroke occurs early after treatment and has high mortality . The risk of symptomatic ICH may be increased in patients with a blood glucose > 200 mg/dL at stroke onset Eleven Type 2 diabetic subjects ( 10 male 1 female : age 56.2 + /- 9.7 ( SD ) yr ) were treated in r and om order either with insulin or with sulphonylureas for 8 weeks each , without attempting to alter glycaemic control between the two treatment periods . Insulin treatment was associated with suppression of endogenous insulin secretion ( fasting C-peptide levels -35.0 + /- 24.2 % ; p = 0.006 ) , and of intact proinsulin ( -43.1 + /- 36.8 % ; p = 0.03 ) and 32,33 split proinsulin -20.1 + /- 27.0 % ; p = 0.03 ) . Activity of plasminogen activator inhibitor ( PAI-1 ) , a fast acting inhibitor of fibrinolysis , decreased significantly ( -14.3 % + /- 27.5 % ; p = 0.02 ) but no changes occurred in concentration of lipoproteins or apoproteins between therapies . Changes in concentrations of 32,33 split and intact proinsulin were closely and significantly related ( rs = 0.83 ; p < 0.001 ) to each other but not with changes in concentrations of C-peptide ( intact proinsulin rs = -0.41 ; p = 0.11 ) and 32,33 split proinsulin rs = -0.27 ; ( p = 0.21 ) . Percentage changes in intact proinsulin concentrations were positively correlated with those in PAI-1 ( rs = 0.51 ; p = 0.05 ) . There was , however a paradoxical negative relationship between changes in C-peptide concentrations and those of PAI-1 ( rs = -0.73 ; p = 0.006 ) . These preliminary observations suggest that insulin treatment in Type 2 diabetic subjects without any changes in glycaemic control is associated with a reduced activity of PAI-1 , but is without effect on any other cardiovascular risk factors . Concentrations of insulin precursor molecules may play a role in determining fibrinolytic activity CONTEXT Glucose-insulin-potassium ( GIK ) infusion is a widely applicable , low-cost therapy that has been postulated to improve mortality in patients with acute ST-segment elevation myocardial infa rct ion ( STEMI ) . Given the potential global importance of GIK infusion , a large , adequately powered r and omized trial is required to determine the effect of GIK on mortality in patients with STEMI . OBJECTIVE To determine the effect of high-dose GIK infusion on mortality in patients with STEMI . DESIGN , SETTING , AND PARTICIPANTS R and omized controlled trial conducted in 470 centers worldwide among 20,201 patients with STEMI who presented within 12 hours of symptom onset . The mean age of patients was 58.6 years , and evidence -based therapies were commonly used . INTERVENTION Patients were r and omly assigned to receive GIK intravenous infusion for 24 hours plus usual care ( n = 10,091 ) or to receive usual care alone ( controls ; n = 10,110
Output:
| Using MRI it has been demonstrated that in patients with acute perfusion diffusion mismatch within 24 hours of stroke onset , acute hyperglycemia correlates with reduced salvage of mismatch tissue from infa rct ion , greater final infa rct size , and worse functional outcome .4 As a consequence , not only has a causal relationship between hyperglycemia and poor outcome been assumed , but also a benefical treatment effect from control of |
MS212160 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: OBJECTIVES In animal models , fat removal results in compensatory weight gain . No study has reported measurement of weight following lipectomy in humans . We have examined changes in weight in patients who underwent lipectomy . METHODS In a retrospective analysis , 16 patients who had abdominoplasty and 17 patients who underwent bilateral breast reduction were compared with 16 patients who had carpal tunnel syndrome release . Following this , a prospect i ve study was carried out on 7 subjects awaiting abdominoplasty and 12 subjects awaiting bilateral breast reduction surgery . RESULTS In the retrospective study , all three patient groups gained weight following surgery . The abdominoplasty group was heavier before surgery and showed greatest weight gain but there was no statistically significant difference in weight gain between the groups . In the prospect i ve study , the abdominoplasty group had a mean fat removal of 1.77 kg and breast reduction group had a mean of 3.22 kg . Eighteen months following surgery the abdominoplasty group showed a significant mean increase in body weight ( mean increase : 4.82 kg ) and body mass index ( BMI ) ( mean increase : 1.66 kg/m(2 ) ) . In the bilateral breast reduction group , there was a non-significant mean gain in weight ( mean increase : 0.67 kg ) and BMI ( mean increase : 0.21 kg/m(2 ) ) . CONCLUSIONS Patients undergoing lipectomy during abdominoplasty and bilateral breast reduction will gain weight in the long term . This weight gain probably reflects the expected gain in weight without surgery as a similar finding is observed in patients who have undergone surgery without lipectomy . These results highlight the limitation of lipectomy as a weight control measure Background : There are no published studies of liposuction or abdominoplasty in a large number of patients using measurements of body dimensions . In the absence of rigorous data , some investigators have proposed that fat returns after liposuction . Methods : A prospect i ve study was undertaken among predominantly nonobese consecutive patients undergoing 301 liposuction and abdominoplasty procedures meeting the study criteria ( inclusion rate , 70.7 percent ) . Lower body dimensions were measured using st and ardized photographs taken before and at least 3 months after surgery . Upper body measurements were compared between women who underwent simultaneous cosmetic breast surgery ( n = 67 ) and a group of women who had breast surgery alone ( n = 78 ) to investigate the possibility of fat redistribution . Results : The average weight change was a loss of 2.2 lbs after lower body liposuction ( p < 0.01 ) and 4.6 lbs when combined with abdominoplasty ( p < 0.001 ) . Liposuction significantly reduced abdominal , thigh , knee , and arm width ( p < 0.001 ) . Midabdominal and hip width were more effectively reduced by lipoabdominoplasty than liposuction alone ( p < 0.001 ) . There was no difference in upper body measurements when comparing patients who had simultaneous liposuction and /or abdominoplasty with patients who had cosmetic breast surgery alone . Measurements in patients with at least 1 year of follow-up ( n = 46 ) showed no evidence of fat reaccumulation . Conclusions : Both liposuction and abdominoplasty are valid techniques for long-term fat reduction and improvement of body proportions . There is no evidence of fat regrowth . CLINICAL QUESTION /LEVEL OF EVIDENCE : Therapeutic , III Background Aim ing to clarify the mechanism of weight loss after the restrictive bariatric procedure of sleeve gastrectomy ( LSG ) , the volumes and pressures of the stomach , of the removed part , and of the remaining sleeve were measured in 20 morbidly obese patients . Methods The technique used consisted of occlusion of the pylorus with a laparoscopic clamp and of the gastroesophageal junction with a special orogastric tube connected to a manometer . Instillation of methylene-blue-colored saline via the tube was continued until the intraluminal pressure increased sharply , or the inflated stomach reached 2,000 cc . After recording of measurements , LSG was performed . Results Mean volume of the entire stomach was 1,553 cc ( 600–2,000 cc ) and that of the sleeve 129 cc ( 90–220 cc ) , i.e. , 10 % ( 4–17 % ) and that of the removed stomach was 795 cc ( 400–1,500 cc ) . The mean basal intragastric pressure of the whole stomach after insufflations of the abdominal cavity with CO2 to 15 mmHg was 19 mmHg ( 11–26 mmHg ) ; after occlusion and filling with saline it was 34 mmHg ( 21–45 mmHg ) . In the sleeved stomach , mean basal pressure was similar 18 mmHg ( 6–28 mmHg ) ; when filled with saline , pressure rose to 43 mmHg ( 32–58 mmHg ) . The removed stomach had a mean pressure of 26 mmHg ( 12–47 mmHg ) . There were no postoperative complications and no mortality . Conclusions The notably higher pressure in the sleeve , reflecting its markedly lesser distensibility compared to that of the whole stomach and of the removed fundus , indicates that this may be an important element in the mechanism of weight loss CONTEXT Liposuction is suggested to result in long-term body fat regain that could lead to increased cardiometabolic risk . We hypothesized that physical activity could prevent this effect . OBJECTIVE Our objective was to investigate the effects of liposuction on body fat distribution and cardiometabolic risk factors in women who were either exercise trained or not after surgery . DESIGN , SETTING , AND PARTICIPANTS Thirty-six healthy normal-weight women participated in this 6-month r and omized controlled trial at the University of Sao Paulo , Sao Paulo , Brazil . INTERVENTIONS Patients underwent a small-volume abdominal liposuction . Two months after surgery , the subjects were r and omly allocated into two groups : trained ( TR , n = 18 , 4-month exercise program ) and nontrained ( NT , n = 18 ) . MAIN OUTCOME MEASURES Body fat distribution ( assessed by computed tomography ) was assessed before the intervention ( PRE ) and 2 months ( POST2 ) , and 6 months ( POST6 ) after surgery . Secondary outcome measures included body composition , metabolic parameters and dietary intake , assessed at PRE , POST2 , and POST6 , and total energy expenditure , physical capacity , and sc adipocyte size and lipid metabolism-related gene expression , assessed at PRE and POST6 . RESULTS Liposuction was effective in reducing sc abdominal fat ( PRE vs. POST2 , P = 0.0001 ) . Despite the sustained sc abdominal fat decrement at POST6 ( P = 0.0001 ) , the NT group showed a significant 10 % increase in visceral fat from PRE to POST6 ( P = 0.04 ; effect size = -0.72 ) and decreased energy expenditure ( P = 0.01 ; effect size = 0.95 ) when compared with TR . Dietary intake , adipocyte size , and gene expression were unchanged over time . CONCLUSION Abdominal liposuction does not induce regrowth of fat , but it does trigger a compensatory increase of visceral fat , which is effectively counteracted by physical activity In a prospect i ve study , indices of glucose homeostasis , lipid profile , and systemic inflammation were monitored after an aesthetic abdominoplasty , aim ing to scrutinize the possible metabolic benefits for abdominal fat removal . Premenopausal females with substantial weight loss ( N = 40 ) undergoing circumferential abdominoplasty ( index group , n = 20 ) or augmentation mammoplasty with mastopexy ( controls , n = 20 ) were recruited . All of them originally underwent Roux-en-Y gastric bypass . Variables included BMI , white blood cell count , C-reactive protein , hemoglobin , total cholesterol and fractions , triglycerides , glucose , and HbA1c . Follow-up reached 20.3 ± 13.6 months for index cases and 29.5 ± 17.4 months for controls . The metabolic and inflammatory indices improved after the bariatric surgery . Subsequent monitoring indicated a stable body weight and biochemical profile in both groups . The exceptions were HDL cholesterol and C-reactive protein , which respectively increased and diminished after the abdominoplasty , consistent with an inflammatory and metabolic advantage for this operation . This is the first long-term study in a weight-stable population to point out such a pattern after abdominoplasty OBJECTIVE To analyze the effects of the surgical removal of subcutaneous adipose tissue by ultrasound-assisted megalipoplasty ( UAM ) on energy expenditure and adipocytokine concentrations in obese women . METHODS Fifteen premenopausal obese women with BMI 37.5+/-6.3 kg/m(2 ) ( range : 30.7 - 53.6 kg/m(2 ) ) underwent UAM . Body composition ( by DEXA ) , resting metabolic rate ( REE ) by indirect calorimetry , insulin resistance ( by the HOMA method ) , leptin , C-reactive protein , interleukin-6 , resistin and adiponectin were measured before and 1 , 3 , 28 and 180 days after the procedure . RESULTS UAM significantly reduced fat mass at day 3 , without further changes in the following days . REE increased at day 3 after UAM , returned to baseline levels at day 28 and significantly declined at day 180 . Leptin levels transiently increased after UAM and then declined according to fat mass reduction . C-reactive protein , interleukin-6 and resistin levels acutely increased after UAM and then returned to the baseline levels . Adiponectin levels acutely declined after the procedure and then stabilized to a plasma level slightly lower than at baseline . Insulin resistance deteriorated in the acute post-operative phase and then improved . CONCLUSION The surgical removal of subcutaneous fat was associated to an acute inflammatory reaction with high REE and insulin-resistance . Later on , the metabolic effects of fat mass removal appeared , with a reduction of leptin levels and REE and an improvement of insulin resistance
Output:
| Improvements in cardiovascular risk profile with largevolume liposuction : A pilot study .
Klein S , Fontana L , Young VL , et al. Absence of an effect of liposuction on insulin action and risk factors for coronary heart disease .
D ’ And rea F , Grella R , Rizzo MR , et al. Changing the metabolic profile by large-volume liposuction : A clinical study conducted with 123 obese women .
Aesthetic Plast Surg .
Giugliano G , Nicoletti G , Grella E , et al. Effect of liposuction on insulin resistance and vascular inflammatory markers in obese women .
Br J Plast Surg .
Swanson E. Photographic measurements in 301 cases of liposuction and abdominoplasty reveal fat reduction without redistribution .
Mohammed BS , Cohen S , Reeds D , Young VL , Klein S. Long-term effects of large-volume liposuction on metabolic risk factors for coronary heart disease .
Rinomhota AS , Bulugahapitiya DU , French SJ , Caddy CM , Griffiths RW , Ross RJ .
Women gain weight and fat mass despite lipectomy at abdominoplasty and breast reduction .
Cintra W , Modolin M , Faintuch J , Gemperli R , Ferreira MC .
C-reactive protein decrease after postbariatric abdominoplasty . |
MS212161 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: Objective —To evaluate the Latrobe Valley Better Health Injury Prevention Program , a regional community based intervention in south east Victoria , Australia . Method —The evaluation design was quasiexperimental including pre-intervention and post-intervention observations in a predominately town dwelling population of approximately 76 000 . There was no comparison community . Process measures included key informant interviews . Impact evaluation utilised self reported changes in injury risk and protective factors , gathered by a r and om household telephone survey . Outcome evaluation was based on five years of emergency department injury surveillance data for the Latrobe Valley . Results —The program built strategic partnerships , increasing the emphasis on local safety . Activities were implemented in the targeted areas of home , sport , and playground injuries . Some 47 000 educational contacts were made with the community and at least 6000 re source items distributed . There were significant increases in home safety knowledge . Some changes in the areas of playground and sport safety were achieved after partnership development with relevant agencies . Poisson regression models showed significant decreases in the presentation rate for all home injury and for the more severe home injuries . Conclusion —This study clearly demonstrates the difficulty of conducting robust evaluation in the absence of readily available and reliable data and adequate budgets . The Latrobe Valley Better Health Program activities contributed to structural , environmental , and organisational changes that have the potential to reduce injury . The extent of this contribution beyond that made by the statewide injury prevention strategy is not able to be determined In a quasi-experimental study , hospital-treated traffic accident injuries were recorded prospect ively for 7 1/2 years in the two Norwegian cities , Harstad and Trondheim . In Harstad the recorded data were used actively in analysis , planning , and implementation of a community-based injury prevention program . Trondheim was the nonequivalent control city . The intervention was divided into three periods , each of 30 months duration . Preventive efforts were implemented to some extent in period 1 , increasingly in period 2 and period 3 . Traffic safety was promoted in an extensive community program based on the Ottawa charter for health promotion . A 26.6 % overall reduction of traffic injury rates was found in Harstad from period 1 to period 3 ( p < 0.01 ) , whereas a corresponding significant increase was found in the comparison city . Analysis of data from other sources were not conclusive in supporting the Trondheim data as showing the national trend . Alternative explanations for the injury rate reduction in Harstad were assessed by means of other available relevant data . The exact mechanisms that brought about the reduction of injury rates were hard to eluci date because so many intervention elements were implemented at the same time . It is concluded that at least some of the reduction was due to behavioural and structural changes brought about by health promotion . Important factors for the effect of and participation in the prevention program were local relevance and continuous feedback of accident injury data OBJECTIVE --To describe the epidemiology of sports injuries occurring in a community during 8 years and to evaluate the outcome of an intervention implemented against injuries occurring in downhill skiing . METHODS --Hospital treated sports injuries occurring in Harstad , Norway ( population 22 600 ) were recorded prospect ively during an 8 year period . A prevention programme targeting downhill skiing injuries was evaluated . RESULTS --2234 sports injuries accounted for 17.2 % of recorded unintentional injuries . Two out of three injuries occurred in team sports . Soccer accounted for 44.8 % of all sports injuries . Downhill skiing injuries had higher mean score on the abbreviated injury scale than all other sports analysed combined ( P < 0.01 ) . Postintervention injury rates for downhill skiing were reduced by 15 % when adjusting for exposure ( P = 0.24 ) . Further observations are needed for assessing the effectiveness of the downhill skiing safety programme . CONCLUSIONS --Strategies for future sports injury prevention include community involvement , particularly sports organisations . Local data analysis seems to justify some priorities , for example , promotion of helmet use in downhill skiing for young adolescents and prevention of lower limb fractures in male soccer players 15 + years old . Prospect i ve hospital recording of injuries provides a tool for the design and outcome evaluation of sports injury intervention research OBJECTIVE To test the feasibility of a hospital-based injury recording for accident analysis and outcome evaluation of bicyclist and pedestrian injury prevention . DESIGN Prospect i ve injury recording lasting 7 1/2 years , using a quasi-experimental design . SETTING The population of Harstad ( 22,000 ) . INTERVENTION Injury data were evaluated in an injury prevention group and used in planning a community-based intervention . Promotion of bicyclist helmet use and pedestrian safe behaviour was implemented by activating public and voluntary organizations and media . A traffic safety pamphlet containing local traffic injury data was distributed . Changes were made in the physical traffic environment . MAIN OUTCOME MEASURES Injury rates for bicyclists and pedestrians . RESULTS In 275 bicyclists upper extremity and head injuries were predominant 70 % were below 16 years . In 137 pedestrians lower extremity injury was most frequent and children below 10 years had the highest injury rates . Significant injury rate reductions were observed after intervention for child bicyclists and pedestrians . CONCLUSION A hospital-based injury recording is feasible for bicyclists and pedestrian accident analysis , planning injury prevention , and outcome evaluation of the programme . This study indicates that a significant injury rate reduction in children may have been the result of the intervention The objective in this study was to calculate costs and benefits caused by a safe community injury prevention programme in Motala , Sweden . The study design was a quasi-experimental evaluation involving an intervention population and a non-r and om control population . All injuries were recorded before and after an intervention programme . The presented calculations show that costs of injuries in a societal perspective decreased from 116 million Swedish Crowns ( SEK ) to 96 million SEK , while the cost for the intervention was estimated at approximately 10 million SEK . Thus , the safe community injury prevention programme in Motala should be judged as cost-effective BACKGROUND Although social ine quality in health has been an argument for community-based injury prevention programmes , intervention outcomes with regard to differences in social st and ing have not been analysed . The objective of this study was to investigate rates of injuries treated in health-care among members of households at different levels of labour market integration before and after the implementation of a WHO Safe Community programme . METHODS A quasi-experimental design was used with pre- and post-implementation data collection covering the total population s < 65 years of age during one year in the programme implementation municipality ( population 41 000 ) and in a control municipality ( population 26 000 ) . Changes in injury rates were studied using prospect i ve registration of all acute care episodes with regard to social st and ing in both areas during the study periods . RESULTS Male members of households categorized as not vocationally active displayed the highest pre-intervention injury rates . Also after the intervention , males in households classified as not vocationally active displayed notably elevated injury rates in both the control and study areas . Households in the study area in which the significant member was employed showed a post-intervention decrease in injury rate among both men ( P < 0.001 ) and women ( P < 0.01 ) . No statistically significant change was observed in households in which the significant member was self-employed or not vocationally active . In the control area , only an aggregate-level decrease ( P < 0.05 ) among members of households in which the significant member was employed was observed . CONCLUSIONS The study displayed areas for improvement in the civic network-based WHO Safe Community model . Even though members of non-vocationally active households , in particular men , were at higher pre-intervention injury risk , they were not affected by the interventions . This fact has to be addressed when planning future community-based injury prevention programmes STUDY OBJECTIVE : To describe a community based programme to prevent fractures result ing from falls and evaluate the outcome in terms of changes in fracture rates and short term hospital care costs . DESIGN : Prospect i ve intervention study . SETTING : The Norwegian municipalities of Harstad ( intervention ) and Trondheim ( reference ) from 1 July 1985 to 30 June 1993 . PARTICIPANTS : The person-years of the study were estimated from yearly census data on people aged 65 years and over . There were 22970 person years in Harstad and 158911 in Trondheim . MEASUREMENTS AND MAIN RESULTS : The variables were selected and coded according to the Nordic system and the data were collected as part of a national injury surveillance system . The first three years of the study provided baseline data , while the last five years involved community based interventions -eg , the removal of environmental hazards in homes and promotion of the use of safe footwear outdoors in winter . Rates of fracture from falls did not decline in nursing homes but decreased 26.3 % in private homes ( p < 0.01 ) . In 65 - 79 year olds , there was a 48.7 % reduction in fall-fracture rates for men in traffic areas in winter ( p < 0.05 ) . The data from the reference city , Trondheim , suggested a significant rise in fractures caused by falls . There was a 16.7 % reduction in hospital admission rates of fall-fracture patients from private homes , indicating a substantial saving in short term hospital costs . The observed fall-fracture rate reductions in private homes and traffic areas suggest that major parts of the interventions were effective . CONCLUSION : Fall-fracture prophylaxis in the aged is possible in a community based setting that utilises high quality , local injury data STUDY OBJECTIVE To do a complete survey of hospital-treated fractures in the aged ( 65 + years old ) and to report the characteristics and distribution of all fractures occurring within this defined population . DESIGN Prospect i ve injury recording study . SETTING The Norwegian municipality of Harstad ( population 23,000 ) during eight years from 1 July 1985 . PARTICIPANTS The person years of the study estimated from yearly census data , were 22,970 . MEASUREMENTS AND MAIN RESULTS The variables were selected and coded according to the Nordic system and the data were collected as part of a national injury surveillance system . Of 753 recorded fractures , nine out of ten were caused by falls . 50.6 % of fractures occurred in private homes , 24.4 % in traffic areas ( traffic accidents excluded ) , 13.3 % in nursing homes . Adjusting for exposure , fracture rates ( per 1000 person years ) were 70.0 in nursing homes , 17.7 in private homes , and 8.5 in traffic areas in winter ( traffic accidents excluded ) . The fracture risk in traffic areas increased fivefold in months with snow . CONCLUSION Nine out of ten fractures in the aged were caused by falls . Although the fracture risk for the elderly living in a nursing home was four times as high as those living in private homes , the volume of fractures occurring in private homes and traffic areas make them a prime target for interventions . Continuous prospect i ve hospital recording of fractures in a community of aged is feasible and provides a tool for targeting interventions and evaluating the outcome of a community fall-fracture prevention programme Objective —To evaluate a community based programme for evidence based prevention of injuries during physical exercise . Design —Quasi-experimental evaluation using an intervention population and a non-r and om control population . Participants — Study municipality ( population 41 000 ) and control municipality ( population 26 000 ) in Sweden . Main outcome measures —Morbidity rate for sports related injuries treated in the health care system ; severity classification according to the abbreviated injury scale ( AIS ) . Results —The total morbidity rate for sports related injuries in the study area decreased by 14 % from 21 to 18 injuries per 1000 population years ( odds ratio 0.87 ; 95 % confidence interval ( CI ) 0.79 to 0.96 ) . No tendency towards a decrease was observed in people over 40 . The rate of moderately severe injury ( AIS 2 ) decreased to almost half ( odds ratio 0.58 ; 95 % CI 0.50 to 0.68 ) , whereas the rate of minor injuries ( AIS 1 ) increased ( odds ratio 1.22 ; 95 % CI 1.06 to 1.40 ) . The risk of severe injuries ( AIS 3–6 ) remained constant . The rate of total sports injury in the control area did not change ( odds ratio 0.93 ; 95 % CI 0.81 to 1.07 ) , and the trends in the study and control areas were not statistically significantly different . Conclusion —An evidence based prevention programme based on local safety rules and educational programmes can reduce the burden of injuries related to physical exercise in a community . Future studies need to look at adjusting the programme to benefit all age groups Preventing children 's thermal injuries requires changes to both the home environment and the behaviour of family members . Two pilot studies were undertaken of a school-based programme that taught children aged 7 - 11 years about burns and scalds hazards , and encouraged changes to the home environment and family practice s through a take-home exercise . Both studies took place at ethnically diverse schools from low/middle-income areas of Waitakere City , New Zeal and . Study 1 involved 55 children who received the programme , and Study 2 involved 64 children who received the programme and 71 children from a control school . The children 's ability to identify the burns and scalds hazards illustrated in a series of pictures was measured before and after the programme . Children who received the programme showed considerable improvement in hazard identification at the post-test , while children at the control school showed minimal improvement . The take-home exercise was completed by 85 % of the children and their families in Study 1 , and 61 % of the participants from the intervention school in Study 2 . In both studies families reported positive safety changes as a result of the programme . The programme appeared equally effective with all the ethnic groups involved . Future development of the programme is discussed
Output:
| Although positive results were reported for some communities , there was no consistent relationship between being a WHO design ated Safe Community and subsequent changes in observed injury rates .
While the frequency of injury in some study communities did reduce following their design ation as a WHO Safe Community , there remains insufficient evidence from which to draw definitive conclusions regarding the effectiveness of the model . |
MS212162 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
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Input: OBJECTIVE To examine the extent to which district health teams could reduce the burden of malaria , a continuing major cause of mortality and morbidity , in a situation where severe re source constraints existed and integrated care was provided . METHODS Antimalarial drugs were prepackaged into unit doses in an attempt to improve compliance with full courses of chemotherapy . FINDINGS Compliance improved by approximately 20 % in both adults and children . There were 50 % reductions in cost to patients , waiting time at dispensaries and drug wastage at facilities . The intervention , which tended to improve both case and drug management at facilities , was well accepted by health staff and did not involve them in additional working time . CONCLUSION The prepackaging of antimalarials at the district level offers the prospect of improved compliance and a reduction in the spread of resistance Abstract Objective To compare the impact of malaria rapid diagnostic tests ( mRDTs ) , used by community health workers ( CHWs ) , on the proportion of children < 5 years of age receiving appropriately targeted treatment with artemisinin‐based combination therapy ( ACT ) , vs. presumptive treatment . Methods Cluster‐r and omized trials were conducted in two contrasting areas of moderate‐to‐high and low malaria transmission in rural Ug and a. Each trial examined the effectiveness of mRDTs in the management of malaria and targeting of ACTs by CHWs comparing two diagnostic approaches : ( i ) presumptive clinical diagnosis of malaria [ control arm ] and ( ii ) confirmatory diagnosis with mRDTs followed by ACT treatment for positive patients [ intervention arm ] , with village as the unit of r and omisation . Treatment decisions by CHWs were vali date d by microscopy on a reference blood slide collected at the time of consultation , to compare the proportion of children < 5 years receiving appropriately targeted ACT treatment , defined as patients with microscopically‐confirmed presence of parasites in a peripheral blood smear receiving artemether‐lumefantrine or rectal artesunate , and patients with no malaria parasites not given ACT . Results In the moderate‐to‐high transmission area , ACT treatment was appropriately targeted in 79.3 % ( 520/656 ) of children seen by CHWs using mRDTs to diagnose malaria , vs. 30.8 % ( 215/699 ) of children seen by CHWs using presumptive diagnosis ( P < 0.001 ) . In the low transmission area , 90.1 % ( 363/403 ) children seen by CHWs using mRDTs received appropriately targeted ACT treatment vs. 7.8 % ( 64/817 ) seen by CHWs using presumptive diagnosis ( P < 0.001 ) . Low mRDT sensitivity in children with low‐density parasitaemia ( < 200 parasites/μl ) was identified as a potential concern . Conclusion When equipped with mRDTs , ACT treatments delivered by CHWs are more accurately targeted to children with malaria parasites . mRDT use could play an important role in reducing overdiagnosis of malaria and improving fever case management within iCCM , in both moderate‐to‐high and low transmission areas . Nonetheless , missed treatments due to the low sensitivity of current mRDTs in patients with low parasite density are a concern . For community‐based treatment in areas of low transmission and /or non‐immune population s , presumptive treatment of all fevers as malaria may be advisable , until more sensitive diagnostic assays , suitable for routine use by CHWs in remote setting s , become available Background It is important that community-based health insurance ( CBHI ) schemes are design ed in such a way as to ensure the relevance of the benefit packages to potential clients . Hence , this paper provides an underst and ing of the preferred benefit packages by different economic status groups as well as urban and rural dwellers for CBHI in Southeast Nigeria . Methods The study took place in rural , urban and semi-urban communities of south-east Nigeria . A question naire was used to collect information from 3070 r and omly picked household heads . Focus group discussion s were used to collect qualitative data . Data was examined for links between preferences for benefit packages with SES and geographic residence of the respondents . Results Respondents in the rural areas and in the lower SES preferred a comprehensive benefit package which includes all inpatient , outpatient and emergencies services , while those in urban areas as well as those in the higher SES group showed a preference for benefit packages which will cover only basic disease control interventions . Conclusion Equity concerns in preferences for services to be offered by the CBHI scheme should be addressed for CBHI to succeed in different context Background The increasing investment in malaria rapid diagnostic tests ( RDTs ) to differentiate malarial and non-malarial fevers , and an awareness of the need to improve case management of non-malarial fever , indicates an urgent need for high quality evidence on how best to improve prescribers ’ practice s. Methods A three-arm stratified cluster-r and omised trial was conducted in 36 primary healthcare facilities from September 2010 to March 2012 within two rural districts in northeast Tanzania where malaria transmission has been declining . Interventions were guided by formative mixed- methods research and were introduced in phases . Prescribing staff from all facilities received st and ard Ministry of Health RDT training . Prescribers from facilities in the health worker ( HW ) and health worker-patient ( HWP ) arms further participated in small interactive peer-group training sessions with the HWP additionally receiving clinic posters and patient leaflets . Performance feedback and motivational mobile-phone text messaging ( SMS ) were added to the HW and HWP arms in later phases . The primary outcome was the proportion of patients with a non-severe , non-malarial illness incorrectly prescribed a ( recommended ) antimalarial . Secondary outcomes investigated RDT uptake , adherence to results , and antibiotic prescribing . Results St and ard RDT training reduced pre-trial levels of antimalarial prescribing , which was sustained throughout the trial . Both interventions significantly lowered incorrect prescribing of recommended antimalarials from 8 % ( 749/8,942 ) in the st and ard training arm to 2 % ( 250/10,118 ) in the HW arm ( adjusted RD ( aRD ) 4 % ; 95 % confidence interval ( CI ) 1 % to 6 % ; P = 0.008 ) and 2 % ( 184/10,163 ) in the HWP arm ( aRD 4 % ; 95 % CI 1 % to 6 % ; P = 0.005 ) . Small group training and SMS were incrementally effective . There was also a significant reduction in the prescribing of antimalarials to RDT-negatives but no effect on RDT-positives receiving an ACT . Antibiotic prescribing was significantly lower in the HWP arm but had increased in all arms compared with pre-trial levels . Conclusions Small group training with SMS was associated with an incremental and sustained improvement in prescriber adherence to RDT results and reducing over-prescribing of antimalarials to close to zero . These interventions may become increasingly important to cope with the wider range of diagnostic and treatment options for patients with acute febrile illness in Africa . Trial registration Clinical Trials.gov ( # NCT01292707 ) 29 January 2011 Background Malaria is a major cause of paediatric morbidity and mortality . As no clinical features clearly differentiate malaria from other febrile illnesses , and malaria diagnosis is challenged by often lacking laboratory equipment and expertise , overdiagnosis and overtreatment is common . Methods Children admitted with fever at the general paediatric wards at Muhimbili National Hospital ( MNH ) , Dar es Salaam , Tanzania from January to June 2009 were recruited consecutively and prospect ively . Demographic and clinical features were registered . Routine thick blood smear microscopy at MNH was compared to results of subsequent thin blood smear microscopy , and rapid diagnostics tests ( RDTs ) . Genus-specific PCR of Plasmodium mitochondrial DNA was performed on DNA extracted from whole blood and species-specific PCR was done on positive sample s. Results Among 304 included children , 62.6 % had received anti-malarials during the last four weeks prior to admission and 65.1 % during the hospital stay . Routine thick blood smears , research blood smears , PCR and RDT detected malaria in 13.2 % , 6.6 % , 25.0 % and 13.5 % , respectively . Positive routine microscopy was confirmed in only 43 % ( 17/40 ) , 45 % ( 18/40 ) and 53 % ( 21/40 ) , by research microscopy , RDTs and PCR , respectively . Eighteen percent ( 56/304 ) had positive PCR but negative research microscopy . Reported low parasitaemia on routine microscopy was associated with negative research blood slide and PCR . RDT-positive cases were associated with signs of severe malaria . Palmar pallor , low haemoglobin and low platelet count were significantly associated with positive PCR , research microscopy and RDT . Conclusions The true morbidity attributable to malaria in the study population remains uncertain due to the discrepancies in results among the diagnostic methods . The current routine microscopy appears to result in overdiagnosis of malaria and , consequently , overuse of anti-malarials . Conversely , children with a false positive malaria diagnosis may die because they do not receive treatment for the true cause of their illness . RDTs appear to have the potential to improve routine diagnostics , but the clinical implication of the many RDT-negative , PCR-positive sample s needs to be eluci date Background Artemisinin-based combination therapy ( ACT ) is the first-line malaria treatment throughout most of the malaria-endemic world . Data on ACT availability , price and market share are needed to provide a firm evidence base from which to assess the current situation concerning quality -assured ACT supply . This paper presents supply side data from ACTwatch outlet surveys in Benin , the Democratic Republic of Congo ( DRC ) , Madagascar , Nigeria , Ug and a and Zambia . Methods Between March 2009 and June 2010 , nationally representative surveys of outlets providing anti-malarials to consumers were conducted . A census of all outlets with the potential to provide anti-malarials was conducted in clusters sample d r and omly . Results 28,263 outlets were censused , 51,158 anti-malarials were audited , and 9,118 providers interviewed . The proportion of public health facilities with at least one first-line quality -assured ACT in stock ranged between 43 % and 85 % . Among private sector outlets stocking at least one anti-malarial , non-artemisinin therapies , such as chloroquine and sulphadoxine-pyrimethamine , were widely available ( > 95 % of outlets ) as compared to first-line quality -assured ACT ( < 25 % ) . In the public/not-for-profit sector , first-line quality -assured ACT was available for free in all countries except Benin and the DRC ( US$ 1.29 [ Inter Quartile Range ( IQR ) : $ 1.29-$1.29 ] and $ 0.52[IQR : $ 0.00-$1.29 ] per adult equivalent dose respectively ) . In the private sector , first-line quality -assured ACT was 5 - 24 times more expensive than non-artemisinin therapies . The exception was Madagascar where , due to national social marketing of subsidized ACT , the price of first-line quality -assured ACT ( $ 0.14 [ IQR : $ 0.10 , $ 0.57 ] ) was significantly lower than the most popular treatment ( chloroquine , $ 0.36 [ IQR : $ 0.36 , $ 0.36 ] ) . Quality -assured ACT accounted for less than 25 % of total anti-malarial volumes ; private-sector quality -assured ACT volumes represented less than 6 % of the total market share . Most anti-malarials were distributed through the private sector , but often comprised non-artemisinin therapies , and in the DRC and Nigeria , oral artemisinin monotherapies . Provider knowledge of the first-line treatment was significantly lower in the private sector than in the public/not-for-profit sector . Conclusions These st and ardized , nationally representative results demonstrate the typically low availability , low market share and high prices of ACT , in the private sector where most anti-malarials are accessed , with some exceptions . The results confirm that there is substantial room to improve availability and affordability of ACT treatment in the surveyed countries . The data will also be useful for monitoring the impact of interventions such as the Affordable Medicines Facility for malaria Background Early diagnosis and prompt , effective treatment of uncomplicated malaria is critical to prevent severe disease , death and malaria transmission . We assessed the impact of rapid malaria diagnostic tests ( RDTs ) by community health workers ( CHWs ) on provision of artemisinin-based combination therapy ( ACT ) and health outcome in fever patients . Methodology /Principal Findings Twenty-two CHWs from five villages in Kibaha District , a high-malaria transmission area in Coast Region , Tanzania , were trained to manage uncomplicated malaria using RDT aided diagnosis or clinical diagnosis ( CD ) only . Each CHW was r and omly assigned to use either RDT or CD the first week and thereafter alternating weekly . Primary outcome was provision of ACT and main secondary outcomes were referral rates and health status by days 3 and 7 . The CHWs enrolled 2930 fever patients during five months of whom 1988 ( 67.8 % ) presented within 24 hours of fever onset . ACT was provided to 775 of 1457 ( 53.2 % ) patients
Output:
| Overall , RDTs were performed safely and effectively by community health workers provided they receive proper training .
Analogous information was largely absent for formal health care workers .
Tests were generally accurate across context s , except for in drug shops where lower specificities were observed .
Conclusions Malaria RDTs are generally used well , though compliance with test results is variable – especially in the formal health care sector . |
MS212163 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Background R and omized controlled trials ( RCT ) are required to test relationships between physical activity and cognition in children , but these must be informed by exploratory studies . This study aim ed to inform future RCT by : conducting practical utility and reliability studies to identify appropriate cognitive outcome measures ; piloting an RCT of a 10 week physical education ( PE ) intervention which involved 2 hours per week of aerobically intense PE compared to 2 hours of st and ard PE ( control ) . Methods 64 healthy children ( mean age 6.2 yrs SD 0.3 ; 33 boys ) recruited from 6 primary schools . Outcome measures were the Cambridge Neuropsychological Test Battery ( CANTAB ) , the Attention Network Test ( ANT ) , the Cognitive Assessment System ( CAS ) and the short form of the Connor 's Parent Rating Scale ( CPRS : S ) . Physical activity was measured habitually and during PE sessions using the Actigraph accelerometer . Results Test- retest intraclass correlations from CANTAB Spatial Span ( r 0.51 ) and Spatial Working Memory Errors ( 0.59 ) and ANT Reaction Time ( 0.37 ) and ANT Accuracy ( 0.60 ) were significant , but low . Physical activity was significantly higher during intervention vs. control PE sessions ( p < 0.0001 ) . There were no significant differences between intervention and control group changes in CAS scores . Differences between intervention and control groups favoring the intervention were observed for CANTAB Spatial Span , CANTAB Spatial Working Memory Errors , and ANT Accuracy . Conclusions The present study has identified practical and age-appropriate cognitive and behavioral outcome measures for future RCT , and identified that schools are willing to increase PE time . Trial registration numberIS RCT N70853932 ( http://www.controlled-trials.com Research supports the positive effects of exercise on cognitive performance by children . However , a limited number of studies have explored the effects specifically on memory . The purpose of this study was to compare the effects of an acute bout of exercise on learning , short-term memory , and long-term memory in a sample of children . Children were r and omly assigned to an exercise condition or to a no-treatment control condition and then performed repeated trials on an auditory verbal learning task . In the exercise condition , participants performed the PACER task , an aerobic fitness assessment , in their physical education class before performing the memory task . In the control condition , participants performed the memory task at the beginning of their physical education class . Results showed that participants in the exercise condition demonstrated significantly better learning of the word lists and significantly better recall of the words after a brief delay . There were not significant differences in recognition of the words after an approximately 24-hr delay . These results provide evidence in a school setting that an acute bout of exercise provides benefits for verbal learning and long-term memory . Future research should be design ed to identify the extent to which these findings translate to academic measures It is widely accepted that aerobic exercise enhances hippocampal plasticity . Often , this plasticity co-occurs with gains in hippocampal-dependent memory . Cross-sectional work investigating this relationship in preadolescent children has found behavioral differences in higher versus lower aerobically fit participants for tasks measuring relational memory , which is known to be critically tied to hippocampal structure and function . The present study tested whether similar differences would arise in a clinical intervention setting where a group of preadolescent children were r and omly assigned to a 9-month after school aerobic exercise intervention versus a wait-list control group . Performance measures included eye-movements as a measure of memory , based on recent work linking eye-movement indices of relational memory to the hippocampus . Results indicated that only children in the intervention increased their aerobic fitness . Compared to the control group , those who entered the aerobic exercise program displayed eye-movement patterns indicative of superior memory for face-scene relations , with no differences observed in memory for individual faces . The results of this intervention study provide clear support for the proposed linkage among the hippocampus , relational memory , and aerobic fitness , as well as illustrating the sensitivity of eye-movement measures as a means of assessing memory AIM to investigate whether increased physical exercise during the school day influenced subsequent cognitive performance in the classroom . METHOD a r and omized , crossover- design trial ( two weeks in duration ) was conducted in six mainstream primary schools ( 1224 children aged 8 - 11y ) . No data on sex was available . Children received a teacher-directed , classroom-based programme of physical exercise , delivered approximately 30 minutes after lunch for 15 minutes during one week and no exercise programme during the other ( order counterbalanced across participants ) . At the end of each school day , they completed one of five psychometric tests ( paced serial addition , size ordering , listening span , digit-span backwards , and digit-symbol encoding ) , so that each test was delivered once after exercise and once after no exercise . RESULTS general linear modelling analysis demonstrated a significant interaction between intervention and counterbalance group ( p<0.001 ) , showing that exercise benefitted cognitive performance . Post-hoc analysis revealed that benefits occurred in participants who received the exercise intervention in the second but not the first week of the experiment and were also moderated by type of test and age group . INTERPRETATION physical exercise benefits cognitive performance within the classroom . The degree of benefit depends on the context of testing and participants ' characteristics . This has implication s for the role that is attributed to physical exercise within the school curriculum The appropriateness of recess in the elementary program continues to be question ed although generally it is believed to be useful by elementary principals despite a dearth of supportive data . This study was a developmental study of the effects of physical activity on concentration . Comparison of passive and directed physical education activities on the concentration of second- , third- , and fourth- grade children was made . The Woodcock-Johnson Test of Concentration showed better performance by the fourth grade rs and within Grade 4 in favor of the physical activity group . A structured physical activity or a classroom activity immediately prior to a concentration task was not detrimental to children in Grade s 2 and 3 . Fourth- grade children performed significantly better on a test of concentration after engaging in a physical activity Abstract This study tested the association between aerobic fitness and executive function and the impact of enhanced , cognitively challenging physical activity on executive function in overweight and lean children . Seventy children aged 9–10 years were assigned to either a 6-month enhanced physical education programme including cognitively dem and ing ( open skill ) activities or curricular physical education only . Pre- and post-intervention tests assessed aerobic capacity ( Leger test ) and two components of executive function : inhibition and working memory updating ( r and om number generation task ) . Indices of inhibition and memory updating were compared in higher- and lower-fit children and intervention effects were evaluated as a function of physical activity programme ( enhanced vs. curricular ) and weight status ( lean vs. overweight ) . Results showed better inhibition in higher- than lower-fit children , extending the existing evidence of the association between aerobic fitness and executive function to new aspects of children ’s inhibitory ability . Overweight children had more pronounced pre- to post-intervention improvements in inhibition than lean children only if involved in enhanced physical education . Such intervention effects were not mediated by aerobic fitness gains . Therefore , the cognitive and social interaction challenges inherent in open skill tasks , even though embedded in a low-dose physical activity programme , may represent an effective means to promote cognitive efficiency , especially in overweight children BACKGROUND The present study examined whether aerobic fitness training of older humans can increase brain volume in regions associated with age-related decline in both brain structure and cognition . METHODS Fifty-nine healthy but sedentary community-dwelling volunteers , aged 60 - 79 years , participated in the 6-month r and omized clinical trial . Half of the older adults served in the aerobic training group , the other half of the older adults participated in the toning and stretching control group . Twenty young adults served as controls for the magnetic resonance imaging ( MRI ) , and did not participate in the exercise intervention . High spatial resolution estimates of gray and white matter volume , derived from 3D spoiled gradient recalled acquisition MRI images , were collected before and after the 6-month fitness intervention . Estimates of maximal oxygen uptake ( VO2 ) were also obtained . RESULTS Significant increases in brain volume , in both gray and white matter regions , were found as a function of fitness training for the older adults who participated in the aerobic fitness training but not for the older adults who participated in the stretching and toning ( nonaerobic ) control group . As predicted , no significant changes in either gray or white matter volume were detected for our younger participants . CONCLUSIONS These results suggest that cardiovascular fitness is associated with the sparing of brain tissue in aging humans . Furthermore , these results suggest a strong biological basis for the role of aerobic fitness in maintaining and enhancing central nervous system health and cognitive functioning in older adults OBJECTIVE : To assess the effect of a physical activity ( PA ) intervention on brain and behavioral indices of executive control in preadolescent children . METHODS : Two hundred twenty-one children ( 7–9 years ) were r and omly assigned to a 9-month afterschool PA program or a wait-list control . In addition to changes in fitness ( maximal oxygen consumption ) , electrical activity in the brain ( P3-ERP ) and behavioral measures ( accuracy , reaction time ) of executive control were collected by using tasks that modulated attentional inhibition and cognitive flexibility . RESULTS : Fitness improved more among intervention participants from pretest to posttest compared with the wait-list control ( 1.3 mL/kg per minute , 95 % confidence interval [ CI ] : 0.3 to 2.4 ; d = 0.34 for group difference in pre-to-post change score ) . Intervention participants exhibited greater improvements from pretest to posttest in inhibition ( 3.2 % , 95 % CI : 0.0 to 6.5 ; d = 0.27 ) and cognitive flexibility ( 4.8 % , 95 % CI : 1.1 to 8.4 ; d = 0.35 for group difference in pre-to-post change score ) compared with control . Only the intervention group increased attentional re sources from pretest to posttest during tasks requiring increased inhibition ( 1.4 µV , 95 % CI : 0.3 to 2.6 ; d = 0.34 ) and cognitive flexibility ( 1.5 µV , 95 % CI : 0.6 to 2.5 ; d = 0.43 ) . Finally , improvements in brain function on the inhibition task ( r = 0.22 ) and performance on the flexibility task correlated with intervention attendance ( r = 0.24 ) . CONCLUSIONS : The intervention enhanced cognitive performance and brain function during tasks requiring greater executive control . These findings demonstrate a causal effect of a PA program on executive control , and provide support for PA for improving childhood cognition and brain health PURPOSE This study was conducted to determine the effect of physical education class enrollment and physical activity on academic achievement in middle school children . METHODS Participants were 214 sixth- grade students r and omly assigned to physical education during either first or second semesters . Moderate and vigorous physical activity ( MVPA ) ( number of 30-min time blocks ) outside of school was assessed using the 3-d physical activity recall ( 3DPAR ) . The 3DPAR time blocks were converted to ordinal data with scores of 1 ( no activity ) , 2 ( some activity ) , or 3 ( activity meeting Healthy People 2010 guidelines ) . Academic achievement was assessed using grade s from four core academic classes and st and ardized test scores ( Terra Nova percentiles ) . RESULTS Grade s were similar regardless of whether students were enrolled in physical education during first or second semesters . Physical education classes averaged only 19 min of MVPA . Students who either performed some or met Healthy People 2010 guidelines for vigorous activity had significantly higher grade s ( P < 0.05 ) than students who performed no vigorous activity in both semesters . Moderate physical activity did not affect grade s. St and ardized test scores were not significantly related to physical education class enrollment or physical activity levels . CONCLUSION Although academic achievement was not significantly related to physical education enrollment , higher grade s were associated with vigorous physical activity , particularly activity meeting recommended Healthy People 2010 levels This individual differences study examined the separability of three often postulated executive functions-mental set shifting ( " Shifting " ) , information updating and monitoring ( " Updating " ) , and inhibition of prepotent responses ("Inhibition")- and their roles in complex " frontal lobe " or " executive " tasks . One hundred thirty-seven college students performed a set of relatively simple experimental tasks that are considered to predominantly tap each target executive function as well as a set of frequently used executive tasks : the Wisconsin Card Sorting Test ( WCST ) , Tower of Hanoi ( TOH ) , r and om number generation ( RNG ) , operation span , and dual tasking . Confirmatory factor analysis indicated that the three target executive functions are moderately correlated with one another , but are clearly separable . Moreover , structural equation modeling suggested that the three functions contribute differentially to performance on complex executive tasks . Specifically , WCST performance was related most strongly to Shifting , TOH to Inhibition , RNG to Inhibition and Updating , and operation span to Updating . Dual task performance was not related to any of the three target functions . These results suggest that it is important to recognize both the unity and diversity of executive functions and that latent variable analysis is a useful approach to study ing the organization and roles of executive functions Children with low aerobic fitness have altered brain function compared to higher-fit children . This study examined the effect of an 8-month exercise intervention on resting state synchrony . Twenty-two sedentary , overweight ( body mass index ≥85th percentile ) children 8 - 11 years old were r and omly assigned to one of two after-school programs : aerobic exercise ( n=13 ) or sedentary attention control ( n=9 ) . Before and after the 8-month programs , all subjects participated in resting state functional magnetic resonance imaging scans . Independent components analysis identified several networks , with four chosen for between-group analysis : salience
Output:
| RESULTS A majority of the research supports the view that physical fitness , single bouts of PA , and PA interventions benefit children 's cognitive functioning .
Evidence indicates that PA has a relationship to areas of the brain that support complex cognitive processes during laboratory tasks .
The present systematic review found evidence to suggest that there are positive associations among PA , fitness , cognition , and academic achievement .
Regardless , the literature suggests no indication that increases in PA negatively affect cognition or academic achievement and PA is important for growth and development and general health .
Therefore , the evidence category rating is B. The literature suggests that PA and PE have a neutral effect on academic achievement . |
MS212164 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Abstract OBJECTIVE : To determine if a simple educational intervention can increase resident physician literature search activity . DESIGN : R and omized controlled trial . SETTING : University hospital-based internal medicine training program . PATIENTS / PARTICIPANTS : Forty-eight medical residents rotating on the general internal medicine service . INTERVENTIONS : One-hour didactic session , the use of well-built clinical question cards , and practical sessions in clinical question building . MEASUREMENTS AND MAIN RESULTS : Objective data from the library information system that included the number of log-ons to MEDLINE , search ing volume , abstract s viewed , full-text articles viewed , and time spent search ing . Median search activity as measured per person per week ( control vs intervention ) : number of log-ons to MEDLINE ( 2.1 vs 4.4 , P<.001 ) ; total number of search sets ( 24.0 vs 74.2 , P<.001 ) ; abstract s viewed ( 5.8 vs 17.7 , P=.001 ) ; articles viewed ( 1.0 vs 2.6 , P=.005 ) ; and hours spent search ing ( 0.8 vs 2.4 , P<.001 ) . CONCLUSIONS : A simple educational intervention can markedly increase resident search ing activity Background Supporting 21st century health care and the practice of evidence -based medicine ( EBM ) requires ubiquitous access to clinical information and to knowledge-based re sources to answer clinical questions . Many questions go unanswered , however , due to lack of skills in formulating questions , crafting effective search strategies , and accessing data bases to identify best levels of evidence . Methods This r and omized trial was design ed as a pilot study to measure the relevancy of search results using three different interfaces for the PubMed search system . Two of the search interfaces utilized a specific framework called PICO , which was design ed to focus clinical questions and to prompt for publication type or type of question asked . The third interface was the st and ard PubMed interface readily available on the Web . Study subjects were recruited from interns and residents on an inpatient general medicine rotation at an academic medical center in the US . Thirty-one subjects were r and omized to one of the three interfaces , given 3 clinical questions , and asked to search PubMed for a set of relevant articles that would provide an answer for each question . The success of the search results was determined by a precision score , which compared the number of relevant or gold st and ard articles retrieved in a result set to the total number of articles retrieved in that set . Results Participants using the PICO templates ( Protocol A or Protocol B ) had higher precision scores for each question than the participants who used Protocol C , the st and ard PubMed Web interface . ( Question 1 : A = 35 % , B = 28 % , C = 20 % ; Question 2 : A = 5 % , B = 6 % , C = 4 % ; Question 3 : A = 1 % , B = 0 % , C = 0 % ) 95 % confidence intervals were calculated for the precision for each question using a lower boundary of zero . However , the 95 % confidence limits were overlapping , suggesting no statistical difference between the groups . Conclusion Due to the small number of search es for each arm , this pilot study could not demonstrate a statistically significant difference between the search protocol s. However there was a trend towards higher precision that needs to be investigated in a larger study to determine if PICO can improve the relevancy of search results PURPOSE The study assesses potential for improving residents ' evidence -based medicine search ing skills in MEDLINE through real-time librarian instruction . SUBJECTS Ten residents on a rotation in a neonatal intensive care unit participated . METHODOLOGY Residents were r and omized into an instruction and a non-instruction group . Residents generated questions from rounds and search ed MEDLINE for answers . Data were collected through observation , search strategy analysis , and surveys . Librarians observed search es and collected data on questions , search ing skills , search problems , and the test group 's instruction topics . Participants performed st and ardized search es before , after , and six-months after intervention and were scored using a search strategy analysis tool ( 1 representing highest score and 5 representing lowest score ) . Residents completed pre- and post-intervention surveys to measure opinions about MEDLINE and search satisfaction . RESULTS Post-intervention , the test group formulated better questions , used limits more effectively , and reported greater confidence in using MEDLINE . The control group expressed less satisfaction with retrieval and demonstrated more errors when limiting . The test and control groups had the following average search scores respectively : 3.0 and 3.5 ( pre-intervention ) , 3.3 and 3.4 ( post-intervention ) , and 2.0 and 3.8 ( six-month post-intervention ) . CONCLUSION Data suggest that measurable learning outcomes were achieved . Residents receiving instruction improved and retained search ing skills six-months after intervention Background Previous studies have shown that Norwegian public health physicians do not systematic ally and explicitly use scientific evidence in their practice . They work in an environment that does not encourage the integration of this information in decision-making . In this study we investigate whether a theoretically grounded tailored intervention to diffuse evidence -based public health practice increases the physicians ' use of research information . Methods 148 self-selected public health physicians were r and omised to an intervention group ( n = 73 ) and a control group ( n = 75 ) . The intervention group received a multifaceted intervention while the control group received a letter declaring that they had access to library services . Baseline assessment s before the intervention and post-testing immediately at the end of a 1.5-year intervention period were conducted . The intervention was theoretically based and consisted of a workshop in evidence -based public health , a newsletter , access to a specially design ed information service , to relevant data bases , and to an electronic discussion list . The main outcome measure was behaviour as measured by the use of research in different documents . Results The intervention did not demonstrate any evidence of effects on the objective behaviour outcomes . We found , however , a statistical significant difference between the two groups for both knowledge scores : Mean difference of 0.4 ( 95 % CI : 0.2–0.6 ) in the score for knowledge about EBM-re sources and mean difference of 0.2 ( 95 % CI : 0.0–0.3 ) in the score for conceptual knowledge of importance for critical appraisal . There were no statistical significant differences in attitude- , self-efficacy- , decision-to-adopt- or job-satisfaction scales . There were no significant differences in Cochrane library search ing after controlling for baseline values and characteristics . Conclusion Though demonstrating effect on knowledge the study failed to provide support for the hypothesis that a theory-based multifaceted intervention targeted at identified barriers will change professional behaviour OBJECTIVE : To evaluate an educational intervention in evidence -based ethics ( emphasizing clinical knowledge , epidemiologic skills , and recognition of ethical issues ) administered to house staff before rotating through our neonatal intensive care unit . STUDY DESIGN : A controlled trial of 64 pediatric house staff assigned to alternating control and intervention rotations . Question naires were administered at the end of the rotation . RESULTS : Some benefits of the intervention were observed . However , a large percentage of intervention and control house staff substantially overestimated ( > 1.25 correct value ) predischarge mortality ( 23 % vs. 55 % of house staff ; p<0.02 ) , mortality or major morbidity ( 74 % vs. 46 % of house staff ; p=0.04 ) , and cerebral palsy rates ( 70 % vs. 87 % ; p=0.12 ) . Neither group cited many method ological criteria for evaluating follow-up studies ( 3.3 vs. 2.4 criteria ; p=0.05 ) or ethical issues considered in treatment recommendations for extremely premature infants ( 3.1 vs. 2.8 issues ; p=0.35 ) . CONCLUSION : Improved house staff training in evidence -based ethics is needed Objective An intervention existing of an evidence -based medicine ( EBM ) course in combination with case method learning sessions ( CMLSs ) was design ed to enhance the professional performance , self-efficacy and job satisfaction of occupational physicians . Methods A cluster r and omized controlled trial was set up and data were collected through question naires at baseline ( T0 ) , directly after the intervention ( T1 ) and 7 months after baseline ( T2 ) . The data of the intervention group [ T0 ( n = 49 ) , T1 ( n = 31 ) , T2 ( n = 29 ) ] and control group [ T0 ( n = 49 ) , T1 ( n = 28 ) , T2 ( n = 28 ) ] were analysed in mixed model analyses . Mean scores of the perceived value of the CMLS were calculated in the intervention group . Results The overall effect of the intervention over time comparing the intervention with the control group was statistically significant for professional performance ( p < 0.001 ) . Job satisfaction and self-efficacy changes were small and not statistically significant between the groups . The perceived value of the CMLS to gain new insights and to improve the quality of their performance increased with the number of sessions followed . Conclusion An EBM course in combination with case method learning sessions is perceived as valuable and offers evidence to enhance the professional performance of occupational physicians . However , it does not seem to influence their self-efficacy and job satisfaction Background To evaluate the educational effects of a clinical ly integrated e-learning course for teaching basic evidence -based medicine ( EBM ) among postgraduates compared to a traditional lecture-based course of equivalent content . Methods We conducted a cluster r and omised controlled trial in the Netherl and s and the UK involving postgraduate trainees in six obstetrics and gynaecology departments . Outcomes ( knowledge gain and change in attitude towards EBM ) were compared between the clinical ly integrated e-learning course ( intervention ) and the traditional lecture based course ( control ) . We measured change from pre- to post-intervention scores using a vali date d question naire assessing knowledge ( primary outcome ) and attitudes ( secondary outcome ) . Results There were six clusters involving teaching of 61 postgraduate trainees ( 28 in the intervention and 33 in the control group ) . The intervention group achieved slightly higher scores for knowledge gain compared to the control , but these results were not statistically significant ( difference in knowledge gain : 3.5 points , 95 % CI -2.7 to 9.8 , p = 0.27 ) . The attitudinal changes were similar for both groups . Conclusion A clinical ly integrated e-learning course was at least as effective as a traditional lecture based course and was well accepted . Being less costly than traditional teaching and allowing for more independent learning through material s that can be easily up date d , there is a place for incorporating e-learning into postgraduate EBM curricula that offer on-the-job training for just-in-time learning . Trial registration Trial registration number : ACTRN12609000022268 Summary Aim To evaluate the educational effectiveness of a clinical ly integrated e-learning course for teaching basic evidence -based medicine ( EBM ) among postgraduate medical trainees compared to a traditional lecture-based course of equivalent content . Methods We conducted a cluster r and omized controlled trial to compare a clinical ly integrated e-learning EBM course ( intervention ) to a lecture-based course ( control ) among postgraduate trainees at foundation or internship level in seven teaching hospitals in the UK West Midl and s region . Knowledge gain among participants was measured with a vali date d instrument using multiple choice questions . Change in knowledge was compared between groups taking into account the cluster design and adjusted for covariates at baseline using generalized estimating equations ( GEE ) model . Results There were seven clusters involving teaching of 237 trainees ( 122 in the intervention and 115 in the control group ) . The total number of postgraduate trainees who completed the course was 88 in the intervention group and 72 in the control group . After adjusting for baseline knowledge , there was no difference in the amount of improvement in knowledge of EBM between the two groups . The adjusted post course difference between the intervention group and the control group was only 0.1 scoring points ( 95 % CI −1.2–1.4 ) . Conclusion An e-learning course in EBM was as effective in improving knowledge as a st and ard lecture-based course . The benefits of an e-learning approach need to be considered when planning EBM curricula as it allows st and ardization of teaching material s and is a potential cost-effective alternative to st and ard lecture-based teaching Abstract Objective : To evaluate the READER model for critical reading by comparing it with a free appraisal , and to explore what factors influence different components of the model . Design : A r and omised controlled trial in which two groups of general practitioners assessed three papers from the general practice section of the BMJ . Setting : Northern Irel and . Subjects : 243 general practitioners . Main outcome measures : Scores given using the READER model ( Relevance , Education , Applicability , Discrimination , overall Evaluation ) and scores given using a free appraisal for scientific quality and an overall total . Results : The hierarchical order for the three papers was different for the two groups , according to the total scores . Participants using the READER method ( intervention group ) gave a significantly lower total score ( P⩽0.01 ) and a lower score for the scientific quality ( P⩽0.0001 ) for all three papers . Overall more than one in five ( 22 % ) , and more men than women , read more than 5 articles a month ( P⩽0.05 ) . Those who were trainers tended to read more articles ( P⩽0.05 ) , and no trainers admitted to reading none . Overall , 58 % ( 135/234 ) ( 68 % ( 76/112 ) of the intervention group ) believed that taking part in the exercise would encourage them to be more critical of published articles in the future ( P⩽0.01 ) . Conclusion : Participants using the READER model gave a consistently lower overall score and applied a more appropriate appraisal to the methodology of the studies . The method was both accurate and repeatable . No intrinsic factors influenced the scores , so the model is appropriate for use by all general practitioners regardless of their seniority , location ,
Output:
| Conclusion This systematic review demonstrates inconsistencies in describing educational interventions for EBP in r and omised and non-r and omised trials . |
MS212165 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Overweight and obesity affects more than 66 % of the adult population and is associated with a variety of chronic diseases . Weight reduction reduces health risks associated with chronic diseases and is therefore encouraged by major health agencies . Guidelines of the National Heart , Lung , and Blood Institute ( NHLBI ) encourage a 10 % reduction in weight , although considerable literature indicates reduction in health risk with 3 % to 5 % reduction in weight . Physical activity ( PA ) is recommended as a component of weight management for prevention of weight gain , for weight loss , and for prevention of weight regain after weight loss . In 2001 , the American College of Sports Medicine ( ACSM ) published a Position St and that recommended a minimum of 150 min wk(-1 ) of moderate-intensity PA for overweight and obese adults to improve health ; however , 200 - 300 min wk(-1 ) was recommended for long-term weight loss . More recent evidence has supported this recommendation and has indicated more PA may be necessary to prevent weight regain after weight loss . To this end , we have reexamined the evidence from 1999 to determine whether there is a level at which PA is effective for prevention of weight gain , for weight loss , and prevention of weight regain . Evidence supports moderate-intensity PA between 150 and 250 min wk(-1 ) to be effective to prevent weight gain . Moderate-intensity PA between 150 and 250 min wk(-1 ) will provide only modest weight loss . Greater amounts of PA ( > 250 min wk(-1 ) ) have been associated with clinical ly significant weight loss . Moderate-intensity PA between 150 and 250 min wk(-1 ) will improve weight loss in studies that use moderate diet restriction but not severe diet restriction . Cross-sectional and prospect i ve studies indicate that after weight loss , weight maintenance is improved with PA > 250 min wk(-1 ) . However , no evidence from well- design ed r and omized controlled trials exists to judge the effectiveness of PA for prevention of weight regain after weight loss . Resistance training does not enhance weight loss but may increase fat-free mass and increase loss of fat mass and is associated with reductions in health risk . Existing evidence indicates that endurance PA or resistance training without weight loss improves health risk . There is inadequate evidence to determine whether PA prevents or attenuates detrimental changes in chronic disease risk during weight gain OBJECTIVE To compare the response of blood glucose levels to intermittent high-intensity exercise ( IHE ) and moderate-intensity exercise ( MOD ) in individuals with type 1 diabetes . RESEARCH DESIGN AND METHODS Seven healthy individuals with type 1 diabetes were tested on two separate occasions , during which either a 30-min MOD or IHE protocol was performed . MOD consisted of continuous exercise at 40 % Vo(2peak ) , while the IHE protocol involved a combination of continuous exercise at 40 % Vo(2peak ) interspersed with 4-s sprints performed every 2 min to simulate the activity patterns of team sports . RESULTS Both exercise protocol s result ed in a decline in blood glucose levels . However , the decline was greater with MOD ( -4.4 + /- 1.2 mmol/l ) compared with IHE ( -2.9 + /- 0.8 mmol/l ; P < 0.05 ) , despite the performance of a greater amount of total work with IHE ( P < 0.05 ) . During 60 min of recovery from exercise , glucose levels remained higher in IHE compared with MOD ( P < 0.05 ) . Furthermore , glucose levels remained stable during recovery from IHE , while they continued to decrease after MOD ( P < 0.05 ) . The stabilization of blood glucose levels with IHE was associated with elevated levels of lactate , catecholamines , and growth hormone during early recovery from exercise ( P < 0.05 ) . There were no differences in free insulin , glucagon , cortisol , or free fatty acids between MOD and IHE . CONCLUSIONS The decline in blood glucose levels is less with IHE compared with MOD during both exercise and recovery in individuals with type 1 diabetes Exercise is an effective intervention for treating hypertension and arterial stiffness , but little is known about which exercise modality is the most effective in reducing arterial stiffness and blood pressure in hypertensive subjects . Our purpose was to evaluate the effect of continuous vs. interval exercise training on arterial stiffness and blood pressure in hypertensive patients . Sixty-five patients with hypertension were r and omized to 16 weeks of continuous exercise training ( n=26 ) , interval training ( n=26 ) or a sedentary routine ( n=13 ) . The training was conducted in two 40-min sessions a week . Assessment of arterial stiffness by carotid – femoral pulse wave velocity ( PWV ) measurement and 24-h ambulatory blood pressure monitoring ( ABPM ) were performed before and after the 16 weeks of training . At the end of the study , ABPM blood pressure had declined significantly only in the subjects with higher basal values and was independent of training modality . PWV had declined significantly only after interval training from 9.44±0.91 to 8.90±0.96 m s−1 , P=0.009 ( continuous from 10.15±1.66 to 9.98±1.81 m s−1 , P = ns ; control from 10.23±1.82 to 10.53±1.97 m s−1 , P = ns ) . Continuous and interval exercise training were beneficial for blood pressure control , but only interval training reduced arterial stiffness in treated hypertensive subjects Aims : Exercise is recommended as prevention , management , and control of all stages of hypertension . There are still controversies about the optimal training dose , frequency , and intensity . We aim ed to study the effect of aerobic interval training on blood pressure and myocardial function in hypertensive patients . Methods and results : A total of 88 patients ( 52.0 ± 7.8 years , 39 women ) with essential hypertension were r and omized to aerobic interval training ( AIT ) ( > 90 % of maximal heart rate , correlates to 85–90 % of VO2max ) , isocaloric moderate intensity continuous training ( MIT ) ( ∼70 % of maximal heart rate , 60 % of VO2max ) , or a control group . Exercise was performed on a treadmill , three times per week for 12 weeks . Ambulatory 24-hour blood pressure ( ABP ) was the primary endpoint . Secondary endpoints included maximal oxygen uptake ( VO2max ) , mean heart rate/24 hour , flow mediated dilatation ( FMD ) , total peripheral resistance ( TPR ) , and myocardial systolic and diastolic function by echocardiography . Systolic ABP was reduced by 12 mmHg ( p < 0.001 ) in AIT and 4.5 mmHg ( p = 0.05 ) in MIT . Diastolic ABP was reduced by 8 mmHg ( p < 0.001 ) in AIT and 3.5 mmHg ( p = 0.02 ) in MIT . VO2max improved by 15 % ( p < 0.001 ) in AIT and 5 % ( p < 0.01 ) in MIT . Systolic myocardial function improved in both exercise groups , diastolic function in the AIT group only . TPR reduction and increased FMD were only observed in the AIT group . Conclusions : This study indicates that the blood pressure reducing effect of exercise in essential hypertension is intensity dependent . Aerobic interval training is an effective method to lower blood pressure and improve other cardiovascular risk factors Background Although disease-specific exercise guidelines for cardiovascular disease ( CVD ) are widely available , it remains uncertain whether these different exercise guidelines are integrated properly for patients with different CVDs . The aim of this study was to assess the inter-clinician variance in exercise prescription for patients with various CVDs and to compare these prescriptions with recommendations from the EXercise Prescription in Everyday practice and Rehabilitative Training ( EXPERT ) tool , a digital decision support system for integrated state-of-the-art exercise prescription in CVD . Design The study was a prospect i ve observational survey . Methods Fifty-three CV rehabilitation clinicians from nine European countries were asked to prescribe exercise intensity ( based on percentage of peak heart rate ( HRpeak ) ) , frequency , session duration , programme duration and exercise type ( endurance or strength training ) for the same five patients . Exercise prescriptions were compared between clinicians , and relationships with clinician characteristics were studied . In addition , these exercise prescriptions were compared with recommendations from the EXPERT tool . Results A large inter-clinician variance was found for prescribed exercise intensity ( median ( interquartile range ( IQR ) ) : 83 ( 13 ) % of HRpeak ) , frequency ( median ( IQR ) : 4 ( 2 ) days/week ) , session duration ( median ( IQR ) : 45 ( 18 ) min/session ) , programme duration ( median ( IQR ) : 12 ( 18 ) weeks ) , total exercise volume ( median ( IQR ) : 1215 ( 1961 ) peak-effort training hours ) and prescription of strength training exercises ( prescribed in 78 % of all cases ) . Moreover , clinicians ’ exercise prescriptions were significantly different from those of the EXPERT tool ( p < 0.001 ) . Conclusions This study reveals significant inter-clinician variance in exercise prescription for patients with different CVDs and disagreement with an integrated state-of-the-art system for exercise prescription , justifying the need for st and ardization efforts regarding integrated exercise prescription in CV rehabilitation PURPOSE This study was design ed to investigate whether , in a dose-response manner , there would be greater health benefits in a group of postmenopausal women completing 45 minute- vs. 30 minutes of moderate intensity ( 50 % maximal oxygen uptake reserve , VO2R ) exercise 5 days . wk(-1 ) . METHODS Apparently healthy but sedentary postmenopausal women ( n = 33 ) were r and omized to a nonexercise control group , a 30-minute exercise duration group , or a 45-minute exercise duration group . Exercise training was performed 5 days . wk(-1 ) for 12 weeks at 50 % VO2R . Participants were instructed to not change their usual diet throughout the study . RESULTS Twenty-six women completed the study . After 12 weeks , VO2max increased significantly ( p < 0.05 ) in both 30-minute ( 0.20 + /- 0.21 L . min(-1 ) ) and 45-minute ( 0.41 + /- 0.10 L . min(-1 ) ) groups . Repeated measures ANOVA identified a significant interaction between exercise duration and VO2max values ( F = 4.72 , p < 0.05 ) , indicating that VO2max responded differently to 30-minute and 45-minute exercise duration s. Trend analysis showed that body mass , body composition , waist circumference , and high-density lipoprotein cholesterol ( HDL-C ) changed favorably ( p < 0.05 ) across control , 30-minute , and 45-minute groups . CONCLUSIONS Although most health organizations agree that 150 min . wk(-1 ) of physical activity will reduce the risk of all-cause and cardiovascular mortality , few r and omized , controlled studies have examined whether completing more physical activity than the recommended amount will yield additional benefits . Findings from the present study suggest that there is a dose-response relationship between exercise duration and numerous health outcomes in postmenopausal women , including cardiorespiratory fitness , body mass , body composition , waist circumference , and Summary No objective evidence has been presented to support the beneficial effect of physical training on glycaemic control in Type 1 ( insulin-dependent ) diabetic patients trained two to three times a week for several months . In the present study we examined the possibility that a daily exercise programme would be more suitable for improving glycaemic control . Thirteen patients completed a 5-month study ; 6 were r and omized to exercise training ( 20 min daily bicycle exercise ) and 7 served as non-exercising controls . The training result ed in an 8 % increase in maximal oxygen uptake ( p < 0.05 ) . No change in glycaemic control occurred during the study period in either group . In addition , serum lipid and lipoprotein levels were followed . Total cholesterol decreased during the study period irrespective of training . No effect was noted on the levels of LDL , VLDL , HDL and HDL2 cholesterol . A significant training effect was obtained in the HDL3 subfraction ( −10%,p < 0.05 ) . Total triglycerides were unchanged , but a decrease in the level of LDL triglycerides was observed with training ( −12%,p < 0.01 ) . It is concluded that , in female Type 1 diabetic patients , daily physical training for several months does not improve glycaemic control and results only in minor changes in serum lipoprotein profiles Background Impaired glucose tolerance ( IGT ) is associated with endothelial dysfunction and upregulation of inflammatory markers , which is potentially reversible by adequate treatment . It was our aim to compare the impact of exercise training with that of rosiglitazone on endothelial function and inflammatory markers in patients with IGT and coronary artery disease ( CAD ) . Methods Patients with IGT and CAD were r and omly assigned to either exercise training ( n = 13 ) , rosiglitazone ( 8 mg ; n = 11 ) , or a control group ( n = 10 ) . During the first week , exercise training consisted of 6 × 15 min/d followed by three weeks of 30 min
Output:
| This contributes to an appropriately tailored exercise regimen for every CVD risk patient |
MS212166 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: OBJECTIVE The objective was to compare targeting increased eating of healthy foods vs. reducing intake of high energy-dense foods within the context of a family-based behavioral weight control program . METHODS AND PROCEDURES Forty-one 8 - 12 year-old children > 85th BMI percentile were r and omly assigned to a 24-month family-based behavioral treatment that targeted increasing fruits and vegetables and low-fat dairy vs. reducing intake of high energy-dense foods . RESULTS Children in the increase healthy food group showed greater reduction in z BMI compared to children in the reduce high energy-dense food group at 12- ( -0.30 z BMI units vs. -0.15 z BMI units , P = 0.01 ) and 24- ( -0.36 z BMI units vs -0.13 z BMI units , P = 0.04 ) month follow-up . Parents in the increase healthy food group showed greater reductions in concern about child weight ( P = 0.007 ) , and these changes were associated with child z BMI change ( P = 0.008 ) . Children in the reduce high energy-dense group showed larger sustained reductions in high energy-dense foods ( P < 0.05 ) . Baseline levels of high energy-dense foods ( P < 0.05 ) , parent food restraint ( P = 0.01 ) , parent concern over parent weight ( P = 0.01 ) and parent acceptance of the child ( P < 0.05 ) moderated child z BMI change , with greater sustained reductions in z BMI for children in the increase healthy food group for each measure . Parent z BMI change followed the same pattern as child changes , and parent and child z BMI changes were correlated ( P < 0.001 ) . DISCUSSION Focusing on healthy food choices within an energy restricted diet may be useful in family-based weight control programs OBJECTIVE The study presents the immediate post-intervention results of Kids and Adults Now - Defeat Obesity ! , a r and omized controlled trial to enhance healthy lifestyle behaviors in mother-preschooler ( 2 - 5 years old ) dyads in North Carolina ( 2007 - 2011 ) . The outcomes include change from baseline in the child 's diet , physical activity and weight , and in the mother 's parenting behaviors , diet , physical activity , and weight . METHOD The intervention targeted parenting through maternal emotion regulation , home environment , feeding practice s , and modeling of healthy behaviors . 400 mother-child dyads were r and omized . RESULTS Mothers in the intervention arm , compared to the control arm , reduced instrumental feeding ( -0.24 vs. 0.01 , p<0.001 ) and TV snacks ( -.069 vs. -0.24 , p=0.001 ) . There were also improvements in emotional feeding ( p=0.03 ) , mother 's sugary beverage ( p=0.03 ) and fruit/vegetable ( p=0.04 ) intake , and dinners eaten in front of TV ( p=0.01 ) ; these differences were not significant after adjustment for multiple comparisons . CONCLUSION KAN-DO , design ed to maximize the capacity of mothers as agents of change , improved several channels of maternal influence . There were no group differences in the primary outcomes , but differences were observed in the parenting and maternal outcomes and there were trends toward improvement in the preschoolers ' diets . Long-term follow-up will address whether these short-term trends ultimately improve weight status PURPOSE To examine the feasibility and efficacy of a theory-driven and family-based program delivered online to promote healthy lifestyles and weights in Chinese American adolescents . METHODS A r and omized controlled study of a web-based intervention was developed and conducted in 54 Chinese American adolescents ( ages , 12 - 15 years ) and their families . Data on anthropometry , blood pressure , dietary intake , physical activity , and knowledge and self-efficacy regarding physical activity and nutrition were collected at baseline and 2 , 6 , and 8 months after the baseline assessment . Data were analyzed using linear mixed modeling . RESULTS The intervention result ed in significant decreases in waist-to-hip ratio and diastolic blood pressure and increases in vegetable and fruit intake , level of physical activity , and knowledge about physical activity and nutrition . CONCLUSION This web-based behavior program for Chinese American adolescents and their families seems feasible and effective in the short-term . Long-term effects remain to be determined . This type of program can be adapted for other minority ethnic groups who are at high-risk for overweight and obesity and have limited access to programs that promote healthy lifestyles This Scientific Statement addresses Parents and Adult Caregivers ( PACs ) as ‘ agents of change ’ for obese children . Evidence is review ed to support the notion that PACs can leverage behavior change and reduce positive energy balance in obese youth , and research opportunities for the field are discussed . The Statement has three specific aims : First , the core behavior change strategies for PACs as used in family-based treatment programs are review ed . These strategies reduce childhood overweight compared to no treatment or nutrition education alone , although their limited potency is recognized . Second , the strength of evidence is evaluated for the hypothesis that greater parental ‘ involvement ’ in treatment is associated with greater reductions in child overweight . Drawing upon r and omized clinical trials that varied the degree/nature of parental involvement , and observational analyses that assessed parental adherence to behavioral strategies , we report limited and inconsistent support . For example , only 17 % of the intervention studies reported differential improvements in child overweight as function of parental involvement after treatment . On the other h and , greater parental adherence predicted better child weight outcomes after 2 and 5 years in certain studies . Third , research gaps identified throughout this review process are delineated and new opportunities for the field are proposed . For example , the assessment of refined parenting phenotypes , cultural tailoring of interventions , examination of family relationships , and incorporating new technologies in treatment represent topics needing further study . A conceptual model is proposed to guide research on underst and ing the determinants of parental feeding and physical-activity parenting practice s. The Statement strives to innovate the scope and potency of PAC treatments for childhood obesity BACKGROUND Childhood obesity is a major public health problem in the United States , particularly among American Indian communities . OBJECTIVE The objective was to evaluate the effectiveness of a school-based , multicomponent intervention for reducing percentage body fat in American Indian schoolchildren . DESIGN This study was a r and omized , controlled , school-based trial involving 1704 children in 41 schools and was conducted over 3 consecutive years , from 3rd to 5th grade s , in schools serving American Indian communities in Arizona , New Mexico , and South Dakota . The intervention had 4 components : 1 ) change in dietary intake , 2 ) increase in physical activity , 3 ) a classroom curriculum focused on healthy eating and lifestyle , and 4 ) a family-involvement program . The main outcome was percentage body fat ; other outcomes included dietary intake , physical activity , and knowledge , attitudes , and behaviors . RESULTS The intervention result ed in no significant reduction in percentage body fat . However , a significant reduction in the percentage of energy from fat was observed in the intervention schools . Total energy intake ( by 24-h dietary recall ) was significantly reduced in the intervention schools but energy intake ( by direct observation ) was not . Motion sensor data showed similar activity levels in both the intervention and control schools . Several components of knowledge , attitudes , and behaviors were also positively and significantly changed by the intervention . CONCLUSIONS These results document the feasibility of implementing a multicomponent program for obesity prevention in elementary schools serving American Indian communities . The program produced significant positive changes in fat intake and in food- and health-related knowledge and behaviors . More intense or longer interventions may be needed to significantly reduce adiposity in this population This study tested the impact of a multicomponent intervention entitled " Partners of all Ages Reading About Diet and Exercise " ( PARADE ) a child-focused energy balance intervention incorporated into mentoring programs . We used a group r and omized nested cohort design r and omizing mentoring program sites ( n = 119 ) and children ( N = 782 ; females = 49 % ; African American = 37 % ; mean ( s.d . ) age = 8.5 ( 1.5 ) years ) to intervention or usual care conditions . PARADE mentors delivered eight lesson plans addressing key concepts related to diet and activity ; eight child-focused computer-tailored storybooks with messages targeting that child 's diet and activity patterns and eight parent action support newsletters . When compared to the control group , PARADE children were more knowledgeable of diet and activity guidelines ( P < 0.01 ) , challenged themselves more to eat five fruits and vegetables ( FV ) ( P < 0.01 ) and be active 1 h daily ( P < 0.01 ) , and to ask for FV for snack ( P = 0.015 ) . Calories from high fat foods decreased in overweight/obese children , but not for normal weight children ( P = 0.059 ) . There were no significant differences in fruit and vegetable intake , total calories , percent time being active , or BMI z-score . The combination of one-to-one mentoring , child-focused computer based tailoring , and parent support may impact important behavioral change precursors in environments over which the child has control , especially among normal weight children . Further , work is needed to evaluate the impact of family-focused multicomponent interventions , including computer-tailored approaches , directed toward both the parent and the child Background The family food environment is an important influence in the development of children ’s dietary habits . Research suggests that influences of current dietary behaviour and behaviour change may differ . The aims of this paper were to : ( 1 ) investigate the association between the food environment at baseline and change in children ’s saturated fat intake ; and ( 2 ) to explore whether a change in the food environment was associated with a change in children ’s saturated fat intake . MethodS econdary analysis of a 12 week cluster r and omised controlled trial in 133 4 - 13 year old children . Families were r and omly allocated to parental education regarding changing to reduced-fat dairy foods or a comparison non-dietary behaviour . The interventions were family focused . Parents received education from a dietitian in 3x30minute sessions to facilitate behaviour change . Parents completed a comprehensive question naire capturing three domains of the food environment – Parent knowledge and attitudes ; shaping practice s ; and behaviours and role modelling . Children ’s dietary intake was assessed via multiple 24-hour recalls at baseline and week 12 . Changes in the family food environment and primary outcome ( saturated fat ) were calculated . Hierarchical linear regression models were performed to explore the association between baseline and change in food environment constructs and change in saturated fat intake . St and ardised Beta are presented ( p<0.05 ) . Results After adjustments for child and family demographics , higher levels of perceived food availability ( β=-0.2 ) at baseline was associated with greater reduction in saturated fat intake , where as higher perceived responsibility ( β=0.2 ) , restriction ( β=0.3 ) and pressure to eat ( β=0.3 ) were associated with lesser change in saturated fat . An increase in nutrition knowledge ( β=-0.2 ) , perceived responsibility ( β=-0.3 ) and restriction ( β=-0.3 ) from baseline to week 12 were associated with greater reduction in saturated fat intake . Conclusions The present study was one of the first to quantify changes in the family food environment , and identify a number of factors which were associated with a positive dietary change . Because interventions focus on behaviour change , the findings may provide specific targets for intervention strategies in the future . Trial registration Australia New Zeal and Clinical Trials Registry ACTRN12609000453280 OBJECTIVE The High 5 for Preschool Kids ( H5-KIDS ) program tested the effectiveness of a home based intervention to teach parents how to ensure a positive fruit-vegetable ( FV ) environment for their preschool child , and to examine whether changes in parent behavior were associated with improvements in child intake . METHODS A group r and omized nested cohort design was conducted ( 2001 to 2006 ) in rural , southeast Missouri with 1306 parents and their children participating in Parents As Teachers , a national parent education program . RESULTS When compared to control parents , H5-KIDS parents reported an increase in FV servings ( MN=0.20 , p=0.05 ) , knowledge and availability of FV within the home ( p=0.01 ) , and decreased their use of noncoercive feeding practice s ( p=0.02 ) . Among preschoolers , FV servings increased in normal weight ( MN=0.35 , p=0.02 ) but not overweight children ( MN=-0.10 , p=0.48 ) , relative to controls . The parent 's change in FV servings was a significant predictor of child 's change in FV in the H5-KIDS group ( p=0.001 ) . CONCLUSION H5-KIDS suggests the need for , and promise of , early home intervention for childhood obesity prevention . It demonstrates the importance of participatory approaches in developing externally valid interventions , with the potential for dissemination across national parent education programs as a means for improving the intake of parents and young children OBJECTIVE To test the hypothesis that family dietary coaching would improve nutritional intakes and weight control in free-living ( noninstitutionalized ) children and parents . DESIGN R and omized controlled trial . SETTING Fifty-four elementary schools in Paris , France . PARTICIPANTS One thous and thirteen children ( mean age
Output:
| The contribution of parental involvement on intervention effectiveness remains unclear . |
MS212167 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
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Input: Theories and empirical studies of adolescent sexual behavior have identified the contributions of personal attributes and social experiences ; however , it is rare that models have clarified developmental pathways to adolescent sexual behavior that include ( 1 ) factors assessed prior to and early in adolescence and ( 2 ) dyadic experiences in adolescence that provide the opportunity for sexual behavior ( i.e. , dating ) . Using data from a prospect i ve study , structural equation modeling was used to test a model predicting adolescent sexual behavior at age 19 , denoted by the number of lifetime sexual partners . Predictors examined were sociability and impulsivity assessed at 30 months of age , physical characteristics and experiences with peers measured at age 12–13 , the age of first romantic relationship , and frequency of alcohol use at age 16 . The pathway to greater sexual involvement was marked by some desired personal attributes ( e.g. , sociability ) and peer experiences ( e.g. , higher quality friendships ) . These associations were mediated , however , by earlier initiation of romantic relationships and more frequent use of alcohol in middle adolescence . Earlier initiation of romantic relationships and more frequent alcohol use were predicted by greater sociability and less impulsivity in childhood , higher quality friendships and greater peer acceptance in early adolescence , and a more mature appearance and physical attractiveness ( among females ) at age 13 . The findings imply a complex pathway that leads to a greater accumulation of sexual partners by age 19 . This pathway begins in childhood and includes individual qualities , peer acceptance , romantic relationships , and alcohol use CONTEXT Despite the recent declines in rates of teenage pregnancy , relatively little is known about the few programs that have been successful in reducing adolescent pregnancy . METHODS Six agencies in New York City each r and omly assigned 100 disadvantaged 13 - 15-year-olds to their usual youth program or to the intervention being tested -- the Children 's Aid Society-Carrera program , a year-round afterschool program with a comprehensive youth development orientation . Both program and control youth were followed for three years . Multivariate regression analyses assessed the effects of program participation on the odds of current sexual activity , use of a condom along with a hormonal contraceptive , pregnancy and access to good health care . RESULTS Seventy-nine percent of participants remained in the program for three full years . Female program participants had significantly lower odds than controls of being sexually active ( odds ratio , 0.5 ) and of having experienced a pregnancy ( 0.3 ) . They had significantly elevated odds of having used a condom and a hormonal method at last coitus ( 2.4 ) . However , participation in the program created no significant impact on males ' sexual and reproductive behavior outcomes . Nonetheless , program participants of both genders had elevated odds of having received good primary health care ( 2.0 - 2.1 ) . CONCLUSIONS This program is one of only four whose evaluation has successfully documented declines in teenage pregnancy using a r and om-assignment design . Better outcomes among males may be achieved if programs reach them even earlier than their teenage years OBJECTIVE To examine the long-term effects of the full Seattle Social Development Project intervention on sexual behavior and associated outcomes assessed at age 21 years . DESIGN Nonr and omized controlled trial with long-term follow-up . SETTING Public elementary schools serving children from high-crime areas in Seattle , Wash. PARTICIPANTS Ninety-three percent of the fifth- grade students enrolled in either the full-intervention or control group were successfully interviewed at age 21 years ( n = 144 [ full intervention ] and n = 205 [ control ] ) . INTERVENTIONS In-service teacher training , parenting classes , and social competence training for children . MAIN OUTCOME MEASURES Self-report measures of all outcomes . RESULTS The full-intervention group reported significantly fewer sexual partners and experienced a marginally reduced risk for initiating intercourse by age 21 years as compared with the control group . Among females , treatment group status was associated with a significantly reduced likelihood of both becoming pregnant and experiencing a birth by age 21 years . Among single individuals , a significantly increased probability of condom use during last intercourse was predicted by full-intervention group membership ; a significant ethnic group x intervention group interaction indicated that after controlling for socioeconomic status , single African Americans were especially responsive to the intervention in terms of this outcome . Finally , a significant treatment x ethnic group interaction indicated that among African Americans , being in the full-intervention group predicted a reduced probability of contracting a sexually transmitted disease by age 21 years . CONCLUSION A theory-based social development program that promotes academic success , social competence , and bonding to school during the elementary grade s can prevent risky sexual practice s and adverse health consequences in early adulthood Background Spanish-dominant Latino youth represent a growing yet underserved segment of the U.S. population , especially in terms of protection from sexually transmitted HIV infection . There is evidence to suggest that this subgroup engages in both risk and protective behaviors that may be different from the behaviors of English-dominant Latino youth . Objective To examine theoretical predictors ( attitude , subjective norm , behavioral beliefs , normative beliefs , control beliefs ) of sexual intercourse and condom use with a sample of Spanish-dominant Latino youth . Methods Participants in this study were part of a larger r and omized controlled intervention design ed to reduce the risk of sexually transmitted HIV among Latino youth . This article is based on preintervention data from 141 Spanish-speaking Latino adolescents ( 77 girls and 64 boys ) who completed a Spanish version of the question naire . Results Multiple regression analyses showed significant effects of attitudes , perceived partner approval , self-pride , and parental pride on intentions to engage in sexual intercourse . Attitudes , intentions to engage in sex in the next 3 months , self-pride , parental pride , goals , and partner approval predicted sexual intercourse in the preceding 3 months . Attitudes , subjective norms , self-efficacy , partner and parental approval , and impulse control beliefs were significant predictors of intentions to use condoms . Conclusions This study represents initial efforts to address the needs of Spanish-dominant Latino youth . The identification of salient beliefs that may predict sexual risk and protective behavior are relevant to the design of culturally and linguistically effective interventions OBJECTIVE African-American adolescents living in high-risk inner-city environments have been disproportionately affected by the epidemics of human immunodeficiency virus ( HIV ) and other sexually transmitted diseases . Underst and ing the factors that influence the use of condoms by adolescents is critical for developing effective behavioral interventions . The present study examined the demographic , psychosocial , and behavioral correlates of condom use among African-American adolescents residing in public housing developments in an HIV epicenter ( San Francisco ) and prospect ively evaluated the stability of these significant cross-sectional variables to predict consistent condom use . DESIGN A prospect i ve study . SETTING Two public housing developments in San Francisco . PARTICIPANTS African-American adolescents and young adults between 12 and 21 years of age were recruited though street outreach and completed a theoretically derived research interview assessing HIV-related knowledge , attitudes , and behaviors . After a 6-month period , adolescents completed a follow-up interview similar to the baseline measure . Among adolescents reporting sexual activity in the 6 months before completing the baseline interview ( n = 116 ) , logistic regression analysis evaluated the influence of demographic , psychosocial , and behavioral factors on consistent condom use . RESULTS Adolescents who had high assertive self-efficacy to dem and condom use ( adjusted odds ratio [ OR ] , 11 ) , perceived peer norms as supporting condom use ( OR , 4.2 ) , had greater impulse control ( OR , 3.7 ) , were male ( OR , 4.7 ) , and were younger ( OR , 2.9 ) were more likely to report consistent condom use . Frequency of sexual intercourse was inversely related to condom use ; adolescents with higher numbers of sexual episodes were less likely to use condoms consistently . Prospect i ve analyses identified the baseline level of condom use as the best predictor of condom use at the 6-month follow-up . Adolescents who were consistent condom users at baseline were 7.4 times as likely to be consistent condom users during the follow-up period . Of those adolescents changing their frequency of condom use during the follow-up interval , significantly more engaged in risky behavior ; 33.3 % changed from consistent to inconsistent condom use , whereas 20.6 % changed from inconsistent to consistent use ( OR , 1.6 ) . CONCLUSIONS The findings suggest that HIV prevention programs need to be implemented early , before high-risk behaviors are established and may be more difficult to modify To estimate trends and determinants of sexual initiation and contraceptive use among adolescent women in Northeast Brazil , multivariate logistic hazard models are used that draw on data from three Demographic and Health Surveys conducted there between 1986 and 1996 . Educational attainment is among the variables found to be associated most consistently with differential risk of engaging in first intercourse during adolescence , including premarital intercourse , and of contraceptive use during sexual initiation . Greater frequency of attending religious services and greater exposure to television are also associated with lower rates of sexual initiation and higher use of contraceptives . Seemingly diminishing returns of education on delayed sexual activity may help explain , in part , observed increases in the absolute level of adolescent sexual experience across survey periods , however . Multilevel modeling techniques pointing to the existence of cluster-level r and om variances underline the need for further research into community influences on individual sexual activity This study assessed the impact of school-based social competence training on skills , social adjustment , and self-reported substance use of 282 sixth and seventh grade rs . Training emphasized broad-based competence promotion in conjunction with domain-specific application to substance abuse prevention . The 20-session program comprised six units : stress management , self-esteem , problem solving , substances and health information , assertiveness , and social networks . Findings indicated positive training effects on Ss ' skills in h and ling interpersonal problems and coping with anxiety . Teacher ratings revealed improvements in Ss ' constructive conflict resolution with peers , impulse control , and popularity . Self-report ratings indicated gains in problem-solving efficacy . Results suggest some preventive impact on self-reported substance use intentions and excessive alcohol use . In general , the program was found to be beneficial for both inner-city and suburban students OBJECTIVES We sought to test the efficacy of an intervention that was design ed to promote social inclusion and commitment to education , in reducing among students health risk behaviors and improving emotional well-being . METHODS The design was a cluster-r and omized trial in 25 secondary schools in Victoria , Australia . The subjects were 8th- grade students ( aged 13 to 14 y ) in 1997 ( n=2545 ) and subsequent 8th- grade students in 1999 ( n=2586 ) and 2001 ( n=2463 ) . The main outcomes were recent substance use , antisocial behavior , initiation of sexual intercourse , and depressive symptoms . RESULTS At 4-year follow-up , the prevalence of marked health risk behaviors was approximately 20 % in schools in the comparison group and 15 % in schools in the intervention group , an overall reduction of 25 % . In ordinal logistic regression models a protective effect of intervention was found for a composite measure of health risk behaviors in unadjusted models ( odds ratio [OR]= 0.69 ; 95 % confidence interval [CI]= 0.50 , 0.95 ) and adjusted models ( OR= 0.71 ; CI = 0.52 , 0.97 ) for potential confounders . There was no evidence of a reduction in depressive symptoms . CONCLUSION The study provides support for prevention strategies in schools that move beyond health education to promoting positive social environments Condom promotion strategies for adolescents typically include provision of STD/HIV-associated knowledge , fostering favorable attitudes toward condom use , promoting positive peer norms regarding condom use , improving condom-related communication skills and self-efficacy , and overcoming barriers to condom use . The purpose of this study was to identify which of these constructs were prospect ively associated with condom use among a high-risk sample of African American adolescent females reporting sexual activity with a steady male partner . Adolescents , 14–18 years old , were recruited from schools and health clinics . Adolescents completed an in-depth survey and interview at baseline and again 6 months later . Analyses were limited to adolescents with steady partners who reported sexual activity between the baseline and 6-month follow-up assessment periods ( N = 179 ) . At baseline , five-scale measures and a single-item measure were used to assess predictive constructs . At follow-up , adolescents were asked about their frequency of condom use over various periods of recall . Multivariate models were created to control for the confounding influence of pregnancy status . The findings were remarkably distinct . The evidence strongly supported the predictive role of perceived barriers toward condom use and peer norms . The measure of sexual communication achieved significance for two of the six assessed outcomes . Alternatively , measures of attitudes toward condom use , condom negotiation self-efficacy , and knowledge about STD/HIV-prevention were consistently nonsignificant . The findings suggest that to improve effectiveness of individual-level STD/HIV prevention programs , design ed for this population , program emphasis should be on reducing barriers to condom use , teaching partner communication skills , and fostering positive peer norms relevant to condom use Predictive effects of school experiences were studied over a 7-year interval in a r and om community sample of 452 adolescents , 12 through 18 years of age . Outcomes examined included dropping out of school , adolescent pregnancy , engaging in criminal activities , criminal conviction , antisocial personality disorder , and alcohol abuse . Logistic regression showed academic achievement , academic aspirations , and leaming-focused school
Output:
| There was insufficient evidence to draw conclusions about emotional and moral competence and ASRH .
Helping adolescents to achieve cognitive , social , and behavioral competence may reduce the likelihood of sexual activity and teen pregnancy , and increase contraceptive use . |
MS212168 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: BACKGROUND In patients with ischemic stroke , endovascular treatment results in a higher rate of recanalization of the affected cerebral artery than systemic intravenous thrombolytic therapy . However , comparison of the clinical efficacy of the two approaches is needed . METHODS We r and omly assigned 362 patients with acute ischemic stroke , within 4.5 hours after onset , to endovascular therapy ( intraarterial thrombolysis with recombinant tissue plasminogen activator [ t-PA ] , mechanical clot disruption or retrieval , or a combination of these approaches ) or intravenous t-PA . Treatments were to be given as soon as possible after r and omization . The primary outcome was survival free of disability ( defined as a modified Rankin score of 0 or 1 on a scale of 0 to 6 , with 0 indicating no symptoms , 1 no clinical ly significant disability despite symptoms , and 6 death ) at 3 months . RESULTS A total of 181 patients were assigned to receive endovascular therapy , and 181 intravenous t-PA . The median time from stroke onset to the start of treatment was 3.75 hours for endovascular therapy and 2.75 hours for intravenous t-PA ( P<0.001 ) . At 3 months , 55 patients in the endovascular-therapy group ( 30.4 % ) and 63 in the intravenous t-PA group ( 34.8 % ) were alive without disability ( odds ratio adjusted for age , sex , stroke severity , and atrial fibrillation status at baseline , 0.71 ; 95 % confidence interval , 0.44 to 1.14 ; P=0.16 ) . Fatal or nonfatal symptomatic intracranial hemorrhage within 7 days occurred in 6 % of the patients in each group , and there were no significant differences between groups in the rates of other serious adverse events or the case fatality rate . CONCLUSIONS The results of this trial in patients with acute ischemic stroke indicate that endovascular therapy is not superior to st and ard treatment with intravenous t-PA . ( Funded by the Italian Medicines Agency , Clinical Trials.gov number , NCT00640367 . ) Background Endovascular or intra-arterial treatment ( IAT ) increases the likelihood of recanalization in patients with acute ischemic stroke caused by a proximal intracranial arterial occlusion . However , a beneficial effect of IAT on functional recovery in patients with acute ischemic stroke remains unproven . The aim of this study is to assess the effect of IAT on functional outcome in patients with acute ischemic stroke . Additionally , we aim to assess the safety of IAT , and the effect on recanalization of different mechanical treatment modalities . Methods / design A multicenter r and omized clinical trial with blinded outcome assessment . The active comparison is IAT versus no IAT . IAT may consist of intra-arterial thrombolysis with alteplase or urokinase , mechanical treatment or both . Mechanical treatment refers to retraction , aspiration , sonolysis , or use of a retrievable stent ( stent-retriever ) . Patients with a relevant intracranial proximal arterial occlusion of the anterior circulation , who can be treated within 6 hours after stroke onset , are eligible . Treatment effect will be estimated with ordinal logistic regression ( shift analysis ) ; 500 patients will be included in the trial for a power of 80 % to detect a shift leading to a decrease in dependency in 10 % of treated patients . The primary outcome is the score on the modified Rankin scale at 90 days . Secondary outcomes are the National Institutes of Health stroke scale score at 24 hours , vessel patency at 24 hours , infa rct size on day 5 , and the occurrence of major bleeding during the first 5 days . Discussion If IAT leads to a 10 % absolute reduction in poor outcome after stroke , careful implementation of the intervention could save approximately 1 % of all new stroke cases from death or disability annually . Trial registration NTR1804 ( 7 May 2009)/IS RCT N10888758 ( 24 July 2012 ) BACKGROUND Trials of endovascular therapy for ischemic stroke have produced variable results . We conducted this study to test whether more advanced imaging selection , recently developed devices , and earlier intervention improve outcomes . METHODS We r and omly assigned patients with ischemic stroke who were receiving 0.9 mg of alteplase per kilogram of body weight less than 4.5 hours after the onset of ischemic stroke either to undergo endovascular thrombectomy with the Solitaire FR ( Flow Restoration ) stent retriever or to continue receiving alteplase alone . All the patients had occlusion of the internal carotid or middle cerebral artery and evidence of salvageable brain tissue and ischemic core of less than 70 ml on computed tomographic ( CT ) perfusion imaging . The co primary outcomes were reperfusion at 24 hours and early neurologic improvement ( ≥8-point reduction on the National Institutes of Health Stroke Scale or a score of 0 or 1 at day 3 ) . Secondary outcomes included the functional score on the modified Rankin scale at 90 days . RESULTS The trial was stopped early because of efficacy after 70 patients had undergone r and omization ( 35 patients in each group ) . The percentage of ischemic territory that had undergone reperfusion at 24 hours was greater in the endovascular-therapy group than in the alteplase-only group ( median , 100 % vs. 37 % ; P<0.001 ) . Endovascular therapy , initiated at a median of 210 minutes after the onset of stroke , increased early neurologic improvement at 3 days ( 80 % vs. 37 % , P=0.002 ) and improved the functional outcome at 90 days , with more patients achieving functional independence ( score of 0 to 2 on the modified Rankin scale , 71 % vs. 40 % ; P=0.01 ) . There were no significant differences in rates of death or symptomatic intracerebral hemorrhage . CONCLUSIONS In patients with ischemic stroke with a proximal cerebral arterial occlusion and salvageable tissue on CT perfusion imaging , early thrombectomy with the Solitaire FR stent retriever , as compared with alteplase alone , improved reperfusion , early neurologic recovery , and functional outcome . ( Funded by the Australian National Health and Medical Research Council and others ; EXTEND-IA Clinical Trials.gov number , NCT01492725 , and Australian New Zeal and Clinical Trials Registry number , ACTRN12611000969965 . ) Rationale Multimodal imaging has the potential to identify acute ischaemic stroke patients most likely to benefit from late recanalization therapies . Aims The general aim of the Mechanical Retrieval and Recanalization of Stroke Clots Using Embolectomy Trial is to investigate whether multimodal imaging can identify patients who will benefit substantially from mechanical embolectomy for the treatment of acute ischaemic stroke up to eight-hours from symptom onset . Design Mechanical Retrieval and Recanalization of Stroke Clots Using Embolectomy is a r and omized , controlled , blinded- outcome clinical trial . Population studied Acute ischaemic stroke patients with large vessel intracranial internal carotid artery or middle cerebral artery M1 or M2 occlusion enrolled within eight-hours of symptom onset are eligible . The study sample size is 120 patients . Study intervention Patients are r and omized to endovascular embolectomy employing the Merci Retriever ( Concentric Medical , Mountain View , CA ) or the Penumbra System ( Penumbra , Alameda , CA ) vs. st and ard medical care , with r and omization stratified by penumbral pattern . Outcomes The primary aim of the trial is to test the hypothesis that the presence of substantial ischaemic penumbral tissue visualized on multimodal imaging ( magnetic resonance imaging or computed tomography ) predicts patients most likely to respond to mechanical embolectomy for treatment of acute ischaemic stroke due to a large vessel , intracranial occlusion up to eight-hours from symptom onset . This hypothesis will be tested by analysing whether pretreatment imaging pattern has a significant interaction with treatment as a determinant of functional outcome based on the distribution of scores on the modified Rankin Scale measure of global disability assessed 90 days poststroke . Nested hypotheses test for ( 1 ) treatment efficacy in patients with a penumbral pattern pretreatment , and ( 2 ) absence of treatment benefit ( equivalency ) in patients without a penumbral pattern pretreatment . An additional aim will only be tested if the primary hypothesis of an interaction is negative : that patients treated with mechanical embolectomy have improved functional outcome vs. st and ard medical management ESCAPE is a prospect i ve , multicenter , r and omized clinical trial that will enroll subjects with the following main inclusion criteria : less than 12 h from symptom onset , age > 18 , baseline NIHSS > 5 , ASPECTS score of > 5 and CTA evidence of carotid T/L or M1 segment MCA occlusion , and at least moderate collaterals by CTA . The trial will determine if endovascular treatment will result in higher rates of favorable outcome compared with st and ard medical therapy alone . Patient population s that are eligible include those receiving IV tPA , tPA ineligible and unwitnessed onset or wake up strokes with 12 h of last seen normal . The primary end-point , based on intention-to-treat criteria is the distribution of modified Rankin Scale scores at 90 days assessed using a proportional odds model . The projected maximum sample size is 500 subjects . R and omization is stratified under a minimization process using age , gender , baseline NIHSS , baseline ASPECTS ( 8–10 vs. 6–7 ) , IV tPA treatment and occlusion location ( ICA vs. MCA ) as covariates . The study will have one formal interim analysis after 300 subjects have been accrued . Secondary end-points at 90 days include the following : mRS 0–1 ; mRS 0–2 ; Barthel 95–100 , EuroQOL and a cognitive battery . Safety outcomes are symptomatic ICH , major bleeding , contrast nephropathy , total radiation dose , malignant MCA infa rct ion , hemicraniectomy and mortality at 90 days BACKGROUND We aim ed to assess the safety and efficacy of thrombectomy for the treatment of stroke in a trial embedded within a population -based stroke reperfusion registry . METHODS During a 2-year period at four centers in Catalonia , Spain , we r and omly assigned 206 patients who could be treated within 8 hours after the onset of symptoms of acute ischemic stroke to receive either medical therapy ( including intravenous alteplase when eligible ) and endovascular therapy with the Solitaire stent retriever ( thrombectomy group ) or medical therapy alone ( control group ) . All patients had confirmed proximal anterior circulation occlusion and the absence of a large infa rct on neuroimaging . In all study patients , the use of alteplase either did not achieve revascularization or was contraindicated . The primary outcome was the severity of global disability at 90 days , as measured on the modified Rankin scale ( ranging from 0 [ no symptoms ] to 6 [ death ] ) . Although the maximum planned sample size was 690 , enrollment was halted early because of loss of equipoise after positive results for thrombectomy were reported from other similar trials . RESULTS Thrombectomy reduced the severity of disability over the range of the modified Rankin scale ( adjusted odds ratio for improvement of 1 point , 1.7 ; 95 % confidence interval [ CI ] , 1.05 to 2.8 ) and led to higher rates of functional independence ( a score of 0 to 2 ) at 90 days ( 43.7 % vs. 28.2 % ; adjusted odds ratio , 2.1 ; 95 % CI , 1.1 to 4.0 ) . At 90 days , the rates of symptomatic intracranial hemorrhage were 1.9 % in both the thrombectomy group and the control group ( P=1.00 ) , and rates of death were 18.4 % and 15.5 % , respectively ( P=0.60 ) . Registry data indicated that only eight patients who met the eligibility criteria were treated outside the trial at participating hospitals . CONCLUSIONS Among patients with anterior circulation stroke who could be treated within 8 hours after symptom onset , stent retriever thrombectomy reduced the severity of post-stroke disability and increased the rate of functional independence . ( Funded by Fundació Ictus Malaltia Vascular through an unrestricted grant from Covidien and others ; REVASCAT Clinical Trials.gov number , NCT01692379 . ) BACKGROUND Among patients with acute ischemic stroke due to occlusions in the proximal anterior intracranial circulation , less than 40 % regain functional independence when treated with intravenous tissue plasminogen activator ( t-PA ) alone . Thrombectomy with the use of a stent retriever , in addition to intravenous t-PA , increases reperfusion rates and may improve long-term functional outcome . METHODS We r and omly assigned eligible patients with stroke who were receiving or had received intravenous t-PA to continue with t-PA alone ( control group ) or to undergo endovascular thrombectomy with the use of a stent retriever within 6 hours after symptom onset ( intervention group ) . Patients had confirmed occlusions in the proximal anterior intracranial circulation and an absence of large is
Output:
| In pooled analysis endovascular treatment , including thrombectomy , was associated with a higher proportion of patients experiencing good ( modified Rankin scale scores ≤2 ) and excellent ( scores ≤1 ) outcomes 90 days after stroke , without differences in mortality or rates for symptomatic intracranial haemorrhage , compared with patients r and omised to medical care alone , including intravenous rt-PA .
The more recent studies ( seven r and omised controlled trials , published or presented in 2015 ) proved better suited to evaluate the effect of adjunctive intra-arterial mechanical thrombectomy on its index disease owing to more accurate patient selection , intravenous rt-PA being administered at a higher rate and earlier , and the use of more efficient thrombectomy devices .
Moderate to high quality evidence suggests that compared with medical care alone in a selected group of patients endovascular thrombectomy as add-on to intravenous thrombolysis performed within six to eight hours after large vessel ischaemic stroke in the anterior circulation provides beneficial functional outcomes , without increased detrimental effects . |
MS212169 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Summary Background Leukotriene B4 ( LTB4 ) recruits and activates neutrophils . Accordingly , this leukotriene is involved in innate defense actions . Objective To examine if nasal LTB4 can produce neutrophil activity and to explore whether or not LTB4 can condition neutrophils to exert virucidal effects in vitro and in vivo . Methods 1 . Twenty-three healthy subjects received nasal LTB4 in a r and omized and sham-controlled design . Symptoms were scored and nasal lavages carried out . Myeloperoxidase ( MPO ) and α-defensins were monitored as indices of neutrophil activity . IL-8 , eosinophil cationic protein ( ECP ) and α2-macroglobulin were measured as indices of pro-inflammatory cytokine production , eosinophil activity , and plasma exudation . 2 . Supernatants from neutrophils activated by LTB4 in vitro were assayed for virucidal activity against respiratory viruses . 3 . In 38 healthy individuals , nasal inoculation with human rhinovirus-16 ( HRV-16 ) was performed . In a preliminary study , intervention with LTB4 was given in a r and omized and controlled design . Symptoms , virus replication , and antibody-titres were monitored . Results 1 . LTB4 produced statistically significant increases in MPO and α-defensins , whereas IL-8 , ECP , and α2-macroglobulin were unaffected . 2 . The supernatants efficiently killed human coronavirus , respiratory syncytial virus , and influenza B virus . 3 . HRV-16 replication was lower in subjects receiving LTB4 , but this difference failed to reach statistical significance . Common cold symptoms and incidence of seroconversion were unaffected . Conclusion Nasal LTB4 induces a selective recruitment/activation of neutrophils . LTB4 can condition neutrophils to exert virucidal effects in vitro and may reduce virus replication in vivo . We suggest that the condition induced by LTB4 reflects an enhanced state of innate defense BACKGROUND . Cysteinyl leukotrienes are implicated in the inflammation of bronchiolitis . Recently , a specific cysteinyl leukotriene receptor antagonist , montelukast ( Singulair [ MSD , Haarlem , Netherl and s ] ) , has been approved for infants in granule sachets . OBJECTIVE . Our goal was to evaluate the effect of montelukast on clinical progress and on cytokines in acute bronchiolitis . METHODS . This was a r and omized , placebo-controlled , double-blind , parallel-group study in 2 medical centers . Fifty-three infants ( mean age : 3.8 ± 3.5 months ) with a first episode of acute bronchiolitis were r and omly assigned to receive either 4-mg montelukast sachets or placebo , every day , from hospital admission until discharge . The primary outcome was length of stay , and secondary outcomes included clinical severity score ( maximum of 12 ) and changes in type 1 and 2 cytokine levels ( including interleukin4/IFN-γ ratio as a surrogate for the T-helper 2/T-helper 1 ratio ) in nasal lavage . RESULTS . Both groups were comparable at baseline , and cytokine levels correlated positively with disease severity . There were neither differences in length of stay ( 4.63 ± 1.88 [ placebo group ] vs 4.65 ± 1.97 days [ montelukast group ] ) nor in clinical severity score and cytokine levels between the 2 groups . No differences in interleukin 4/IFN-γ ratio between the 2 groups were seen . There was a slight tendency for infants in the montelukast group to recover more slowly than those in the placebo group ( clinical severity score at discharge : 6.1 ± 2.4 vs 4.8 ± 2.2 , respectively ) . CONCLUSIONS . Montelukast did not improve the clinical course in acute bronchiolitis . No significant effect of montelukast on the T-helper 2/T-helper 1 cytokine ratio when given in the early acute phase could be demonstrated Background : Controlled clinical trials on the effects of leukotriene antagonists on asthma‐like symptoms , bronchial hyperresponsiveness and airway inflammation have not been performed in elite athletes Effective treatment of respiratory symptoms , airway inflammation and impairment of lung function is the goal of any asthma therapy . Although montelukast has been shown to be a possible add-on therapy for anti-inflammatory treatment in older children , its efficacy in infants and young children is not well known . The aim of this study was to investigate its effect in infants and young children with early childhood asthma . In a prospect i ve r and omised double-blind placebo-controlled study , 24 young children ( 10–26 months ) with wheeze , allergy and a positive family history of asthma consistent with the diagnosis of early childhood asthma were r and omised to receive montelukast 4 mg or placebo . The forced expiratory volume in 0.5 seconds ( FEV0.5 ) was measured using the raised volume rapid thoracic compression technique , and fractional exhaled nitric oxide ( FeNO ) and symptom scores were determined . No change was noted in FEV0.5 , FeNO or symptom score in the placebo group following the treatment period . In contrast , significant improvements in mean±sd FEV0.5 ( 189.0±37.8 and 214.4±44.9 mL before and after treatment , respectively ) , FeNO ( 29.8±10.0 and 19.0±8.5 ppb ) and median symptom score ( 5.5 and 1.5 ) were noted following treatment with montelukast . In conclusion , montelukast has a positive effect on lung function , airway inflammation and symptom scores in very young children with early childhood asthma RATIONALE A pilot study ( Bisgaard H ; Study Group on Montelukast and Respiratory Syncytial Virus . A r and omized trial of montelukast in respiratory syncytial virus postbronchiolitis . Am J Respir Crit Care Med 2003;167:379 - 383 ) reported the efficacy of montelukast in post-respiratory syncytial virus ( RSV ) bronchiolitic respiratory symptoms . OBJECTIVES To evaluate the efficacy and safety of montelukast , 4 and 8 mg , in treating recurrent respiratory symptoms of post-RSV bronchiolitis in children in a large , multicenter study . METHODS This was a double-blind study of 3- to 24-month-old children who had been hospitalized for a first or second episode of physician-diagnosed RSV bronchiolitis and who tested positive for RSV . Patients ( n = 979 ) were r and omized to placebo or to montelukast at 4 or 8 mg/day for 4 weeks ( period I ) and 20 weeks ( period II ) . The primary end point was percentage symptom-free days ( % SFD ; day with no daytime cough , wheeze , and shortness of breath , and no nighttime cough ) . MEASUREMENTS AND MAIN RESULTS No significant differences were seen between montelukast and placebo in % SFD over period I : mean + /- SD for placebo and for montelukast at 4 and 8 mg were 37.0 + /- 30.7 , 38.6 + /- 30.4 , and 38.5 + /- 29.9 , respectively . Least-squares mean differences ( 95 % confidence interval ) between montelukast ( 4 mg ) and placebo and between montelukast ( 8 mg ) and placebo were 1.9 % ( -2.9 , 6.7 ) and 1.6 % ( -3.2 , 6.5 ) , respectively . Secondary end points were similar across treatments . Both doses were generally well tolerated . During the first two treatment weeks , average % SFD was approximately 29 % . In post hoc analyses of patients ( n = 523 ) with persistent symptoms ( % SFD < or = 30 % over Weeks 1 - 2 ) , differences in % SFD were seen between montelukast and placebo over Weeks 3 - 24 : difference were 5.7 ( 0.0 , 11.3 ) for montelukast ( 4 mg ) minus placebo and 5.9 ( 0.1 , 11.7 ) for montelukast ( 8 mg ) minus placebo . CONCLUSIONS In this study , montelukast did not improve respiratory symptoms of post-RSV bronchiolitis in children Our aim was to investigate the effectiveness of montelukast in recurrently wheezy infants . We r and omised 113 , 6–24-month-old children with recurrent wheezing to receive either placebo or montelukast daily for an 8-week period . The primary end-point was symptom-free days . The secondary aims were to evaluate the effect of montelukast on rescue medication , on lung function , airway responsiveness and exhaled nitric oxide fraction ( FeNO ) . Clinical response and FeNO were determined , the functional residual capacity ( FRC ) and specific airway conductance ( sGaw ) were measured using an infant whole-body plethysmograph , the maximal flow at functional residual capacity ( V′max , FRC ) was recorded using the squeeze technique and airway responsiveness was evaluated by performing a dosimetric methacholine challenge test . There was no significant difference in changes in weekly symptom-free days between the montelukast and the placebo group ( 3.1–3.7 days versus 2.7–3.1 days , p = 0.965 ) . No significant differences were detected in the secondary end-points , i.e. use of rescue medication , FRC , sGaw , V′max , FRC , FeNO or airway responsiveness between groups . Montelukast therapy did not influence the number of symptom-free days , use of rescue medication , lung function , airway responsiveness or airway inflammation in recurrently wheezy , very young children BACKGROUND Acute wheezing illnesses in preschoolers require better management strategies to reduce morbidity . OBJECTIVES We sought to examine the effectiveness of episodic use of an inhaled corticosteroid and a leukotriene receptor antagonist in preschoolers with intermittent wheezing . METHODS In a r and omized , double-blind , placebo-controlled 12-month trial , 238 children aged 12 to 59 months with moderate-to-severe intermittent wheezing received 7 days of either budesonide inhalation suspension ( 1 mg twice daily ) , montelukast ( 4 mg daily ) , or placebo in addition to albuterol with each identified respiratory tract illness ( RTI ) . Proportion of episode-free days ( EFDs ) during the 12-month trial was the primary outcome . RESULTS The 3 treatment groups did not differ in proportions of EFDs , with adjusted mean EFDs of 76 % ( 95 % CI , 70 % to 81 % ) for budesonide , 73 % ( 95 % CI , 66 % to 79 % ) for montelukast , and 74 % ( 95 % CI , 65 % to 81 % ) for conventional therapy ( P = .66 ) . The 3 groups did not differ in oral corticosteroid use , health care use , quality of life , or linear growth . However , during RTIs , budesonide and montelukast therapy led to modest reductions in trouble breathing ( 38 % [ P = .003 ] and 37 % [ P = .003 ] , respectively ) and interference with activity scores ( 32 % [ P = .01 ] and 40 % [ P = .001 ] , respectively ) that were most evident in those with positive asthma predictive indices . CONCLUSIONS In preschool children with moderate-to-severe intermittent wheezing , episodic use of either budesonide or montelukast early in RTIs , when added to albuterol , did not increase the proportion of EFDs or decrease oral corticosteroid use over a 12-month period . However , indicators of severity of acute illnesses were reduced , particularly in children with positive asthma predictive indices BACKGROUND : Infections with viruses causing upper respiratory tract infection ( URI ) are associated with increased leukotriene levels in the upper airways . Montelukast , a selective leukotriene-receptor antagonist , is an effective treatment of asthma and allergic rhinitis . OBJECTIVE : To determine whether prophylactic treatment with montelukast reduces the incidence and severity of URI in children . METHODS : A r and omized , double-blind , placebo-controlled study was performed in 3 primary care pediatric ambulatory clinics in Israel . Healthy children aged 1 to 5 years were r and omly assigned in a 1:1 ratio to receive 12-week treatment with 4 mg oral montelukast or look-alike placebo . Patients were excluded if they had a previous history of reactive airway disease . A study coordinator contacted the parents by phone once a week to obtain information regarding the occurrence of acute respiratory episodes . The parents received a diary card to record any acute symptoms of URI . The primary outcome measure was the number of URI episodes . RESULTS : Three hundred children were recruited and r and omly assigned into montelukast ( n = 153 ) or placebo ( n = 147 ) groups . One hundred thirty-one ( 85.6 % ) of the children treated with montelukast and 129 (
Output:
| Individual analyses of these studies did not show significant differences between the leukotriene inhibitors group and the control group in symptom-free days and incidence of recurrent wheezing .
The current evidence does not allow definitive conclusions to be made about the effects of leukotriene inhibitors on length of hospital stay and clinical severity score in infants and young children with bronchiolitis . |
MS212170 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: The position of lumbar epidural catheters was confirmed by radiography in 71 patients . Catheters were advanced by 5 cm cephalad in the lumbar epidural space by paramedian approach ( Group P : n = 28 ) or median one ( Group M : n = 43 ) and contrast media was injected through the catheters . If the contrast media was present in the paravertebral regions , the catheter was considered to be in the abnormal position . The incidence of the abnormal position of the catheters was higher in group M than in group P significantly . To advance an epidural catheter longer into the lumbar epidural space , paramedian approach may be superior to median one Epidural catheter insertion may be associated with blood vessel trauma or nerve root irritation . The purpose of this study was to assess whether the injection of small amounts of fluid through the Tuohy needle prior to catheter insertion reduced the incidence of these and other minor complications . Two hundred patients in labour , requesting epidural analgesia , were r and omly assigned to one of three groups : Group I —the catheter was inserted without previous injection of fluid ; Group II —3 ml , 1.5 per cent lidocaine hydrochloride was injected through the needle prior to catheter insertion ; Group III —3 ml , saline was injected prior to catheter insertion . There were no differences among the groups in the incidence of blood vessel trauma or paraesthesiae . We conclude that there is no advantage in injecting of fluid routinely into the epidural space prior to catheter insertion . RésuméUn cathéter qui pénètre dans l’espace épidural peut irriter une racine nerveuse ou transpercer un vaisseau . Nous avons essayé de diminuer l’incidence de ces complications en injectant du liquide dans l’aiguille de Tuohy avant d’y introduire le cathéter . Nous avons r and omisé en trois groupes , 200 c and i date s à l’analgésie épidurale pendant le travail . Dans le groupe I , nous insérions le cathéter sans injection préalable alors que dans les groupes II et III , nous injections respectivement 3 ml de lidocaïne à 1,5 pour cent et 3 ml de soluté physiologique avant de passer le cathéter . Nous n’avons pu démontrer quelque différence que ce soit entre les groupes quant à l’incidence de traumatisme vasculaire ou de paresthésie . Il ne semble donc pas y avoir d’avantage à injecter de liquide dans l’espace épidural avant d’y introduire un cathéter The extent of epidural anaesthesia and pattern of spread of contrast medium , using different injection techniques , has not been well documented . Therefore , in this prospect i ve , r and omized , double-blind study , the extent of anaesthesia and pattern of spread of contrast medium following an epidural bolus injection , via either a Tuohy needle or an epidural catheter , were compared . The study had two parts . In the first , 59 of 79 patients scheduled for a lower extremity operation under epidural anaesthesia were r and omly allocated to one of the two groups . Anaesthesia was achieved with an epidural injection of 10 to 15 ml ( including a 3 ml test dose ) of 0.75 % ropivacaine and fentanyl 25 μg via either a Tuohy needle ( Group N , n=31 ) or a catheter ( Group C , n=28 ) . The level of sensory anaesthesia was recorded . In the second part , the remaining 20 patients were r and omized to initially receive 5 ml of contrast medium via either a Tuohy needle ( Group NE , n=10 ) or a catheter ( Group CE , n=10 ) . The extent of spread was recorded radiologically . Unilateral or missed blocks and additional dose requirement were absent in Groups N and C. No differences were found in the extent of sensory anaesthesia or the spread of contrast medium . Twenty per cent of catheter tips lay outside the lateral margins of the vertebral bodies . We found that an epidural bolus injection , via either a Tuohy needle or a catheter , made no difference in regard to spread of local anaesthetic or contrast medium in the epidural space The effects of injecting normal saline 4 ml through the epidural needle before catheter passage on ease of catheterisation and incidence of certain complications were investigated in 189 non-obstetric patients . The use of saline had no effect on ease of catheterisation , with 84.2 % of Group S patients ( saline , n = 95 ) and 88.3 % of Group C patients ( control , n = 94 ) having the difficulty of passing the catheter rated as " easy " ( P = 0.31 ) . The incidence of complications was not affected by the use of saline . Paraesthesia occurred in 27.4 % of Group S patients compared with 16.0 % of Group C patients ( P = 0.08 ) . Epidural venous cannulation occurred in 6.3 % of Group S patients versus 11.7 % of Group C patients ( P = 0.30 ) . We conclude that the use of 5 ml of normal saline prior to catheter threading provides no significant benefit in improving the ease of catheterisation or decreasing the incidence of catheter complications A system has been constructed to evaluate the design , implementation , and analysis of r and omized control trials ( RCT ) . The degree of quadruple blinding ( the r and omization process , the physicians and patients as to therapy , and the physicians as to ongoing results ) is considered to be the most important aspect of any trial . The analytic techniques are scored with the same emphasis as is placed on the control of bias in the planning and implementation of the studies . Description of the patient and treatment material s and the measurement of various controls of quality have less weight . An index of quality of a RCT is proposed with its pros and cons . If published papers were to approximate these principles , there would be a marked improvement in the quality of r and omized control trials . Finally , a reasonable st and ard design and conduct of trials will facilitate the interpretation of those with conflicting results and help in making valid combinations of undersized trials Although epidural anaesthesia and analgesia are widely used in obstetrics , there are no large contemporary prospect i ve series detailing associated complications . Prospect i ve data was collected on all obstetric epidural blocks performed for labour and delivery in a single institution between July 1989 and August 1994 . A data entry sheet was compiled and entered onto a computer data base . Confidence intervals for proportions were calculated using st and ard methods . Information from 10 995 epidural blocks was analysed . Epidural analgesia in labour was the primary indication in 7648 , and anaesthesia for caesarean section in 3311 . Minor complications included failed or ab and oned insertion ( incidence 0.5 % ) , reinsertion of the epidural catheter ( 5 % ) , and inadequate anaesthesia ( 1.7 % ) or analgesia ( 0.9 % ) . Three percent were associated with venous puncture and 0.6 % with accidental dural puncture . Maternal mortality was zero . Unexpectedly high blocks occurred on eight occasions ( 0.07 % ) , two requiring intubation and ventilation . Three women ( 0.06 % ) experienced mild respiratory depression after postoperative epidural opioid . There was no major local anaesthetic toxicity or neurological deficit . The incidence of potentially life-threatening morbidity was thus 0.02 % although in both cases outcome was good . The only persisting complication was neurological , an apparent epidural catheter-induced traumatic mononeuropathy BACKGROUND The technique of epidural volume extension ( EVE ) involves the injection of saline into the extradural space immediately following the intrathecal injection , as part of a combined spinal-epidural ( CSE ) anaesthetic . One of the suggested benefits of EVE is a reduction in local anaesthetic required . The aim of this study was to test this hypothesis by comparing the median effective doses ( ED50 ) of hyperbaric bupivacaine with fentanyl 25 microg with and without EVE for Caesarean section . METHODS Sixty women were r and omized to receive either CSE anaesthesia with EVE ( EVE group ) or no EVE ( NEVE group ) . Using a double-blinded , up-down sequential technique , varying doses of bupivacaine with fentanyl 25 microg were administered . ED50 was estimated from up-down reversals and probit regression . RESULTS The ED50 for bupivacaine was similar and not significantly different in the two groups ( 5.1 mg in the EVE and 6.1 mg in the NEVE group ; difference 1.0 mg , 95 % CI -0.12 to 2.2 , P=0.08 ) . CONCLUSIONS This study illustrates that whilst low doses of intrathecal bupivacaine can be effectively used for Caesarean section , at such doses EVE does not appear to offer reliable or clinical ly relevant reductions in dosing with intrathecal bupivacaine Background This study prospect ively evaluated the ability of aspiration to detect intravascular placement of multiple‐orifice epidural catheters . Methods Multiple‐orifice , 20‐gauge epidural catheters were inserted in 1,029 laboring women . Catheters were observed and aspirated for blood or cerebrospinal fluid before they were tested with 2 ml local anesthetic . If the results of this test were negative ( no spinal anesthesia ) , the authors induced and maintained labor analgesia with a dilute local anesthetic and opioid solution . Patients with bilateral sensory change and effective labor analgesia had a “ positive ” epidural catheter . Women with unilateral block , inadequate analgesia despite some sensory change or those who delivered before being adequately assessed had “ equivocal ” catheters . Patients with neither analgesia nor sensory change had “ negative ” catheters . Results Aspiration and observation identified 60 intravenously placed catheters . Six catheters , which were placed initially in a blood vessel , were withdrawn until aspiration was negative , and then the anesthetic was infused . Four of these catheters were positive and two were still positioned intravascularly . Two other catheters may have been intravenously placed despite negative results of aspiration . The incidence of false‐negative results of aspiration was 0 to 2 of 1,085 ( upper limit of 95 % CI , 0.2 % to 0.4 % ) . No patient showed any signs or symptoms of local anesthetic toxicity . Conclusions Under the conditions of this study , which include using multiple‐orifice catheters and dilute solutions of local anesthetic and opioid , aspiration and incremental drug injection alone safeguard against the risks of intravenously positioned local anesthetics . These results should not be extrapolated to other clinical setting s without further study STUDY OBJECTIVE To compare a multiport , firm-tipped , close-ended , epidural catheter ( Portex catheter ) with a uniport , open-ended , soft-tipped , wire-reinforced catheter ( Arrow catheter ) in obstetric patients . STUDY DESIGN Prospect i ve data collection for intradepartmental quality assurance . SETTING Obstetric unit in a tertiary care maternity hospital . PATIENTS 2612 patients requesting labor analgesia . INTERVENTIONS The Arrow catheter was used in 1,352 women and the Portex catheter in 1,260 women . MEASUREMENTS AND MAIN RESULTS The incidence of unsatisfactory block were 3.3 % and 4.4 % with the Arrow and Portex catheters , respectively ( p = 0.2 ) . The catheter perforated the dura matter in 0.4 % of cases with both catheters . The incidence of epidural venipuncture was 1.1 % with the Arrow catheter and 5.7 % with the Portex catheter ( p = 0.0001 ) . Paresthesias occurred in 6 % of cases with the Arrow catheter and 11 . 2 % of cases with the Portex catheter ( p = 0.0001 ) . Epidural catheter reinsertion was required in fewer patients in the Arrow group than in the Portex group ( 4.8 % vs. 7.1 % ; p = 0.01 ) . CONCLUSIONS In obstetric patients , the softer uniport Arrow catheter produces paresthesias and venipunctures less frequently than the firm multiport Portex catheter Purpose To examine the effects of the volume of saline and the concentration of local anesthetic on the quality of anesthetic level . Methods One hundred and fifty two patients received thoracic epidural anesthesia were allocated into two groups ; mepivacaine 1 % ( 75 patients ) and 1.5 % ( 77 patients ) . Each group was r and omly divided into three sub-groups depending on epidural saline volumes of 1 ml , 5 ml , or 10 ml . Fifteen minutes after the injection of 10 ml mepivacaine , the dermatome levels of hypesthesia to cold and pinprick were determined by an individual blinded to the saline volume . Results The number of spinal segments with hypesthesia to cold in the three subgroups in the mepivacaine 1 % group were 12.5 [ 6–20 ] , 13 [ 8.5–20.5 ] and 12.5 [ 6.5–22 ] , respectively ( median [ range ] ) . The segments in the mepivacaine 1.5 % group were 12 [ 7–
Output:
| The paramedian as opposed to midline needle approach and smaller epidural needle or catheter gauges do not reduce the risk of epidural vein cannulation .
CONCLUSION : The risk of intravascular placement of a lumbar epidural catheter in pregnancy may be reduced with the lateral patient position , fluid predistension , a single orifice catheter , a wire-embedded polyurethane epidural catheter and limiting the depth of catheter insertion to 6 cm or less . |
MS212171 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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***EXAMPLES***
Input: Background Allergy test results can differ based on the method used . The most common tests include skin-prick testing ( SPT ) and in vitro tests to detect allergen-specific IgE. This study was design ed to assess allergy test results using SPT , individual specific IgE tests , and a multiallergen IgE assay ( multiple allergen simultaneous test ) in patients with chronic rhinitis and controls . Methods One hundred forty total patients were prospect ively enrolled in the study , including 100 patients with chronic rhinitis and 40 control patients without atopy . All eligible patients underwent SPT , serum analysis using individual specific IgE test , and multiple allergen simultaneous test against 10 common allergens . Allergy test results were then compared to identify correlation and interest agreement . Results There was an 81–97 % agreement between SPT and individual specific IgE test in allergen detection and an 80–98 % agreement between SPT and multiple allergen simultaneous test . Individual specific IgE test and multiple allergen simultaneous test allergy detection prevalence was generally similar to SPT in patients with chronic rhinitis . All control patients had negative SPT ( 0/40 ) , but low positive results were found with both individual specific IgE test ( 5–12.5 % ) and multiple allergen simultaneous test ( 2.5–7.5 % ) to some allergens , especially cockroach , Dermatophagoides farina , and ragweed . Agreement and correlation between individual specific IgE test and multiple allergen simultaneous test were good to excellent for a majority of tested allergens . Conclusion This study shows good agreement and correlation between SPT with individual specific IgE test and multiple allergen simultaneous test on a majority of the tested allergens for patients with chronic rhinitis . Comparing the two in vitro tests , individual specific IgE test agrees with SPT better than multiple allergen simultaneous test Background Grass allergen immunotherapy ( AIT ) reduces symptom severity in seasonal allergic rhinoconjunctivitis ( ARC ) but its impact on general health-related utility has not been characterised for the purpose s of economic evaluation . The aim of this study was to model the preferred measure of utility , EQ-5D index , from symptom severity and estimate incremental quality adjusted life years ( QALYs ) associated with SQ-st and ardised grass immunotherapy tablet ( GRAZAX ® , 75,000 SQ-T/2,800 BAU , ALK , Denmark ) . Methods Data were analysed from five consecutive pollen seasons in a r and omised placebo controlled trial of GRAZAX ® . Binomial and Gaussian mixed effects modelling related weekly EQ-5D index score to daily symptom and medication scores ( DSS & DMS respectively ) . In turn , daily EQ-5D index was estimated from ARC symptoms and medication use . Results DSS and DMS were the principal predictors of ‘ perfect ’ health ( EQ-5D = 1.000 ; binomial ) and ‘ imperfect ’ health ( EQ-5D < 1.000 ; Gaussian ) . Each unit increase in DSS and DMS reduced the odds of ‘ perfect ’ health ( EQ-5D = 1.000 ) by 27 % and 16 % respectively , and reduced ‘ imperfect ’ health by 0.17 and 0.13 , respectively . Gender remained the only other significant main fixed effect ( Male odds ratio [ OR ] = 1.82 ) . Incremental estimated EQ-5D index utility for GRAZAX ® was observed from day -30 to day + 70 of the pooled pollen season ; mean daily utility for GRAZAX ® = 0.938 units ( 95%CI 0.932 - 0.943 ) vs. 0.914 ( 0.907 - 0.921 ) for placebo , an incremental difference of 0.0238 ( p < 0.001 ) . This translates into an incremental 0.0324 Quality Adjusted Life Years over the five year study period . Conclusions ARC symptoms and medication use are the main predictors of EQ-5D index . The incremental QALYs observed for GRAZAX ® may not fully describe the health benefits of this treatment , suggesting that economic modelling may be conservative Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of an intervention to be underestimated or overestimated . The Cochrane Collaboration ’s tool for assessing risk of bias aims to make the process clearer and more BACKGROUND The sensitisation profile at molecular level in plant-food allergy is complex . Several allergens may be involved , with different potential for severe reactions . lipid transfer proteins ( LTP ) are considered the most relevant plant-food allergens in adults in Mediterranean countries , but less is known in children . AIM To describe the clinical pattern and sensitisation profile of children with plant-food allergy and LTP sensitisation from Northeast Spain . METHODS Children with history of immediate reaction to plant-food(s ) , positive skin-prick-test to the culprit plant-food(s ) and specific-IgE to plant-food LTPs were analysed . RESULTS 130 children were included . 69.2 % ( 90/130 ) had reacted to ≥2 taxonomically unrelated plant-foods . Peach , walnut , hazelnut and peanut were most frequently involved . Reactions severity ranged from anaphylaxis ( 45.4 % , 59/130 ) to oral symptoms only . Sensitisation to a particular plant-food LTP not always caused clinical symptoms with that plant-food ; 69 % ( 40/58 ) and 63 % ( 17/27 ) of peach- and walnut-tolerant subjects had positive rPru p 3 and nJug r 3 specific IgE , respectively . 65.4 % ( 85/130 ) of children were also sensitised to storage proteins , which was associated to anaphylaxis and nut allergy . However , 60 % of patients without nuts/seeds allergy were sensitised to storage proteins . Specific-IgE levels to LTPs and /or storage proteins were not useful to predict allergy ( vs. tolerance ) to peach , walnut , peanut or hazelnut . CONCLUSIONS Sensitisation to LTP and /or storage proteins without clear clinical significance is relatively common . Prospect i ve longitudinal studies are required to evaluate the relevance of these silent sensitisations over time . Caution is required when interpreting the results of molecular-based diagnostic tools in clinical practice Background One fourth of the adult population in Europe suffer from respiratory allergy . Subcutaneous-allergen-specific-immunotherapy ( SCIT ) has long-term disease modifying effect on disease specific Health-Related Quality of Life ( HRQoL ) . The purpose of this study was to assess the effect of SCIT on alternative disease outcomes in patients with grass-pollen and /or house dust mite induced allergic rhino-conjunctivitis and /or an asthma diagnosis . Focus was on expressing outcomes in terms of generic quality of life ( Quality -Adjusted-Life-Years ( QALY ) ) and reductions in sick days . Methods The study was a multi-centre study with prospect i ve follow-up . 248 patients were initiated on SCIT . The disease specific Rhino-conjunctivitis Quality of Life Question naire ( RQLQ ) and two generic ( HRQoL ) instruments 15D and EQ-5D were used at baseline and at follow-up . The outcome measures included change in ; disease severity , RQLQ-scores , number of days with symptoms- and number of sick days per year and finally changes in generic HRQoL and thus , QALY . Disease severity was assessed by specialist doctors ; severity of rhino-conjunctivitis was classified according to the Allergic Rhinitis and its Impact on Asthma ( ARIA ) and asthma severity according to the Global Initiative for Asthma ( GINA guideline ) . The remaining outcome measures were assessed by the patients in question naires at baseline and at follow-up . An intension to treat approach was applied . For missing items imputation of sample mean base-line values or follow-up values were used after specified criteria . The effect of SCIT on rhino-conjunctivitis and /or asthma diagnoses was analysed at follow-up using three logistic regression models . Results The disease severity showed significantly improved disease control . Mean RQLQ-score was reduced from 3.02 at baseline to 2.00 at follow-up . Average annual days with symptoms were reduced from 189 to 145 days whilst annual sick days were reduced from 3.7 to 1.2 days . The 15D-score increased from 0.83 to 0.86 and the EQ-5D-score from 0.70 to 0.77 , which indicated an annual gain per patient of 0.03 - 0.06 QALY . Conclusions Allergic patients suffering from rhino-conjunctivitis alone or rhino-conjunctivitis and asthma experience significantly increased HRQoL and they gain 0.03 - 0.06 QALY , when treated with SCIT for one year . Trial registration The study was registered at Clinical Trials.gov with the identifier : NCT01486498 BACKGROUND Allergic rhinoconjunctivitis is a global health problem . Around 14 million people in Spain , France , Italy , and Austria suffer from grass pollen induced allergic rhinitis . St and ard care only provides symptoms relief , while allergen specific immunotherapy ( SIT ) treats the underlying cause of the disease . Grazax from ALK-Abelló is a new , tablet-based , effective route of SIT for home treatment . The objective was to assess the cost-effectiveness of Grazax in four Southern European countries . METHODS A prospect i ve pharmacoeconomic analyses was carried out alongside a multinational , clinical trial measuring the efficacy of Grazax . Pooled data on re source use and health outcomes were collected . A societal perspective was adopted , and the analysis had a nine-year time horizon . The primary outcome measure was quality adjusted life years ( QALYs ) . RESULTS Grazax was superior to st and ard care for all efficacy endpoints , including QALYs gained , and result ed in significantly less use of rescue medication and fewer hours missed from work . Grazax was cost-effective for all countries for an annual price in the range of 1500 euros - 1900 euros . The result was improved by inclusion of future costs of asthma and exclusion of Spanish trial centers which experienced an exceptionally low pollen season . CONCLUSION The analysis illustrates that allergen SIT with Grazax for grass pollen induced rhinoconjunctivitis is a cost-effective intervention in Southern Europe The objective of this study was to develop and test a health‐related quality of life question naire for clinical trials in rhinoconjunctivitis . The Rhinoconjunctivitis Quality of Life Question naire ( RQLQ ) was developed by asking patients to identify areas of their lives affected by rhinoconjunctivitis . The result ant RQLQ was tested for reproducibility , responsiveness and validity in a r and omized , double‐blind trial of regular versus ‘ as required ’ aqueous beclomethasone dipropionate ( BDP ) nasal spray in ragweed pollen‐induced rhinoconjunctivitis . Eighty‐five patients from previous rhinoconjunctivitis studies participated in the developmental survey . Sixty ragweed‐sensitive patients , from previous trials and media notices , were enrolled in the clinical trial . Aqueous BDP ( 800 μg ) nasal spray was administered regularly or ‘ as required ’ throughout the ragweed pollen season . The survey revealed that , in addition to local symptoms of rhinoconjunctivitis , patients experienced impairment of quality of life through systemic symptoms , sleep disturbance , practical problems , activity limitations and emotional problems . The RQLQ includes 28 questions related to these dimensions . Repeated administration of the RQLQ demonstrated good reproducibility . During the clinical trial , the RQLQ proved responsive in its ability to distinguish between regular and ‘ as required ’ medication use . Validity was shown by moderate to strong relations between changes in symptom diary scores and changes in RQLQ scores . In conclusion the RQLQ is likely to prove useful as a measure of health‐related quality of life in clinical trials in both rhinoconjunctivitis and rhinitis Background : Currently , the diagnosis of IgE‐mediated allergy is based on allergen‐specific history and diagnostic procedures using natural allergen extracts for in vivo and in vitro tests OBJECTIVES /HYPOTHESIS Health utility value ( HUV ) is an index used to measure health-related quality of life for the valuation and comparison of treatments . The Euroqol 5-Dimension ( EQ-5D ) question naire is a widely used method for determining HUV , but it has not been applied for this purpose in patients with chronic rhinosinusitis ( CRS ) who undergo sinus surgery . STUDY DESIGN Prospect i ve cohort study . METHODS Patients with CRS , who were recruited from 11 different otolaryngologic practice s , completed the EQ-5D question naire at baseline , as well as 3 , 12 , and 24 months after surgery . HUVs calculated from the results of this question naire were compared to those reported in the general U.S. population and to patients suffering from other chronic diseases . RESULTS Baseline EQ-5D surveys were completed by 242 patients . Mean baseline HUV ( st and ard deviation ) was 0.81 ( 0.13 ) . Female gender , revision surgery , and the use of intraoperative image guidance were associated was significantly lower baseline values . HUV rose at 3 months to 0.89 ( 0.12 ) and remained improved at 12 months 0.88 ( 0.10 ) and 24
Output:
| The very limited available data indicated that the addition of multiplex allergen testing [ ImmunoCAP ( ® ) Immuno Solid-phase Allergen Chip ( ISAC ) , Thermo Fisher Scientific/Phadia AB , Uppsala , Sweden ] to st and ard diagnostic work-up can change the clinicians ' views on the diagnosis , management and treatment of patients .
There was some indication that the use of ImmunoCAP ISAC testing may be useful to guide decisions on the discontinuation of restrictive diets , the content of allergen-specific immunotherapy ( SIT ) prescriptions , and whether or not patients should receive SIT .
There was some evidence that ImmunoCAP ISAC may be useful for discriminating allergens that are structurally similar and are recognised by the same IgE antibody ( cross-immunoreactive ) .
Detailed cost analyses suggested that multiplex allergen testing would have to result in a substantial reduction of the proportions of patients receiving single IgE testing and oral food challenge tests in order to be cost-saving in the short term . |
MS212172 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: BACKGROUND As a continuation of two large-scale , multicentre studies on the development of 5-year-old ICSI children , we present results of the follow-up study undertaken on the cognitive and motor development of 8-year-old ICSI children . METHODS Developmental outcomes of 151 8-year-old singletons born through ICSI after 32 weeks of gestation were compared with those of 153 singletons of the same age born after spontaneous conception ( SC ) . Part of this population was seen in a cohort at the age 5 years . Outcome measures include Wechsler Intelligence Scale for Children-Revised ( WISC-R ) and Movement Assessment Battery for Children ( ABC ) . RESULTS Regarding intellectual functioning , ICSI children tend to obtain significantly higher total ( P < 0.01 ) , verbal ( P < 0.01 ) and performance ( P < 0.05 ) intelligence scores than SC children , nevertheless remaining in similar ranges . These effects are small ( Cohen 's d < 0.50 ) . High maternal educational level stayed in the regression as a factor accounting for some of the variance in total IQ between the groups . In terms of motor development , no significant differences were found between ICSI and SC children regarding overall motor skills , manual , balance and ball skills . CONCLUSION In this follow-up study , ICSI and SC children show a comparable cognitive and motor development until the age of 8 years Long-term follow-up studies on the health of children born after assisted reproduction technologies are m and atory . Vision and hearing are the most important senses that continue to develop during childhood . There are few reports on vision and hearing in preschool children born after assisted conception . This prospect i ve controlled blinded follow-up study examined 276 term-born singleton intracytoplasmic injection ( ICSI ) children and 273 spontaneously conceived controls at a mean age of 5.5 years and performed detailed vision and hearing test and clinical ly examined eyes and ears . There was no significant difference between ICSI and control children regarding the occurrence of vision or hearing impairments . Unsurprisingly , children with abnormalities in otoscopy were more likely to have an abnormal hearing test compared with children without abnormalities . Only 8.5 % of ICSI parents and 25.4 % of control parents whose children showed an abnormal hearing test knew about the hearing problems of their child . In conclusion , there was no difference in the development of hearing and vision in ICSI children and spontaneously conceived controls . But only few parents knew about hearing problems of their child after undergoing routine screening examinations . Parental interviews would therefore not be sufficient in order to assess vision and hearing in follow-up studies Recent studies have given conflicting results regarding growth in children born following assisted reproductive treatments up to the age of 18years . It has been suggested that children conceived via IVF may be taller than naturally conceived children and that this may due to subtle epigenetic alteration of imprinted genes as a result of the IVF process . A prospect i ve match-controlled study was performed to investigate the growth of children born in the UK following st and ard IVF and intracytoplasmic sperm injection ( ICSI ) up to the age of 12years . The study assessed 143 IVF and 166 ICSI children with 173 matched naturally conceived controls . Primary end-points were height and weight at various time points : birth , 5years , 7 - 9years and 10 - 12years . In addition , head circumference was assessed at birth . No significant differences were observed regarding head circumference , height and weight between the three groups at any of the time points . In conclusion , this preliminary study provides reassuring information regarding the growth of IVF and ICSI children up to 12years . Further studies must continue to investigate the growth and other outcomes in assisted-conception children as they develop through puberty into early adulthood OBJECTIVE To study the health of children born after ICSI and of spontaneously conceived control children at the age of 4 - 6 years . DESIGN Prospect i ve , controlled , blinded study . SETTING Tertiary-care center . PATIENT(S ) Two hundred seventy-six term-born singletons conceived by ICSI and 273 matched spontaneously conceived singletons at the age of 5.5 years . INTERVENTION(S ) Detailed physical examination , interview of the parents , and collection of data from each child 's examination booklet . MAIN OUTCOME MEASURE(S ) Biometrical data ; current health status ; acute , chronic and childhood illnesses ; hospitalizations ; and surgeries . RESULT ( S ) Detailed physical examination did not reveal any relevant differences between ICSI and spontaneously conceived children . There were no relevant differences regarding the incidence of childhood illnesses , acute or chronic illnesses , accidents , and surgeries up to the age of 5.5 years . However , a history of undescended testicles was found significantly more often in boys born after ICSI ( 5.4 % vs. 0.7 % ) , with the consequence that they had significantly more urogenital surgery ( 19.2 % vs. 8.9 % ) . Significantly more ICSI children had been hospitalized ( 37.6 % vs. 27.2 % ) , although we did not find any specific reason for the increased hospitalization rate . CONCLUSION ( S ) Other than an increased risk of undescended testicles and therefore an increase in urogenital surgeries in ICSI boys , the physical health of ICSI children was comparable to that of spontaneously conceived children at the age of 5.5 years Background : There is accumulating evidence that in vitro conception in humans may be associated with adverse health outcomes later in life . It has been proposed that suboptimal early life conditions may ‘ program ' key endocrine systems . A disturbance of the hypothalamic-pituitary-adrenal ( HPA ) axis leading to alterations in cortisol secretion in the offspring may be such a mechanism . To date , no data on cortisol levels in children conceived by intracytoplasmic sperm injection ( ICSI ) are available in the literature . Methods : In this cross-sectional study , salivary cortisol known as a key regulator of metabolism was measured and results were compared between 201 pubertal ICSI children and 196 spontaneously conceived ( SC ) counterparts . Results : ICSI females had lower mean salivary cortisol levels ( 9.0 µg/l ; 95 % CI 8.1 - 9.9 ) than SC females ( 10.6 µg/l ; 95 % CI 9.7 - 11.5 ; p = 0.01 ) . This difference remained after adjusting for current characteristics , early life factors and maternal characteristics . In ICSI males , no difference in cortisol levels was found in comparison with the SC group . Conclusion : In our study , 14-year-old female but not male ICSI teenagers were found to have lower salivary cortisol concentrations in comparison with SC peers . However , before definite conclusions can be drawn , our results should be completed by longitudinal sampling The aim of this prospect i ve follow-up study of children born after intracytoplasmic sperm injection ( ICSI ) was to compile data on karyotypes , congenital malformations , growth parameters and developmental milestones in order to evaluate the safety of this new technique . The study design included karyotyping of the parents and their agreement to genetic counselling and prenatal diagnosis and it was based on a physical examination of the child at the Centre for Medical Genetics at the ages of 2 months , 1 year and at 2 years , where major and minor malformations and psychomotor evolution are recorded . Here we describe the first 57 children born from 40 ICSI pregnancies with epididymal spermatozoa ( group 1 ) , the first 50 children born from 34 ICSI pregnancies with testicular spermatozoa ( group 2 ) and the first 58 children born from 48 pregnancies after replacement of cryopreserved ICSI embryos ( group 3 ) . Parental karyotypes were obtained from only 72/246 ( 29 % ) parents and were all normal . Prenatal karyotypes were determined for a total of 70 sample s ( 40 % ) : 21 in group 1 , 15 in group 2 and 34 in group 3 . In this last group 2 abnormal 47,XXY karyotypes ( 5.8 % ) and no structural aberrations were found . This increase in de-novo sex-chromosomal aberrations has already been described with regard to the first 877 children born after ICSI carried out at our Centre and is probably linked directly to the characteristics of the infertile men treated rather than to the ICSI procedure itself . Major malformations , defined as those causing functional impairment or requiring surgical correction , were observed in four children : two born after ICSI with epididymal spermatozoa , one after ICSI with testicular spermatozoa and one after ICSI and cryopreservation . No particular malformation was disproportionally frequent . In the follow-up examinations at 2 months ( 107/161 or 66.5 % ) and at 1 year ( 37/161 or 22.9 % ) , no additional anomalies were observed . Lost for follow-up rate at 2 months was 33.5 % . These observations on a limited number of children do not suggest a higher incidence of diseases linked to imprinting , nor do they suggest a higher incidence of congenital malformations . These observations are still limited in number and should be further completed by others and by collaborative efforts . In the meanwhile patients should be told about the available data before any treatment : there appears to be some risk of transmitted chromosomal aberrations , of de-novo , mainly sex-chromosomal aberrations and of transmitting fertility problems to the offspring . Patients should also be reassured that until now there seems to be no higher incidence of congenital malformations in children born after ICSI with epididymal or testicular spermatozoa or after replacement of ICSI embryos STUDY QUESTION Does ovarian hyperstimulation , the in vitro procedures required for in vitro fertilization (IVF)/ intracytoplasmic sperm injection or the combination of both , affect the neurological outcome of 4-year-old singletons ? SUMMARY ANSWER Ovarian hyperstimulation , the in vitro procedure and the combination of both , were not associated with the worse neurological outcome in 4-year-old singletons . WHAT IS KNOWN ALREADY Assisted reproduction techniques ( ARTs ) are not associated with neurological dysfunction during the first post-natal years ; however , effects on the long-term neurological outcome are still inconclusive . An increased time to pregnancy ( TTP , a proxy for the severity of subfertility ) has been associated with a less optimal neurological condition at age 2 . The present study focuses on the neurodevelopmental outcome of 4-year-old ART-offspring . STUDY DESIGN , SIZE , DURATION Longitudinal , prospect i ve follow-up study . PARTICIPANTS , SETTING , METHODS Four-year-old singletons born to subfertile parents ( subfertile group , n = 195 ) , including singletons born after controlled ovarian hyperstimulation IVF ( COH-IVF , n = 63 ) , modified natural cycle IVF ( MNC-IVF , n = 53 ) and natural conception ( Sub-NC , n = 79 ) . Data on underlying cause of subfertility and TTP were present . In addition , we assessed newly recruited 4-year-old singletons born to fertile parents after natural conception ( reference group , n = 98 ) . Neurological development was evaluated with the neurological examination according to Hempel , result ing in a neurological optimality score ( NOS ) , a fluency score and the occurrence of the clinical ly relevant form of minor neurological dysfunction ( complex MND ) . The primary outcome was the fluency score , as fluency of movements is easily reduced by subtle brain dysfunction . Data were analysed with univariable and multivariable regression analyses , in which special attention was paid to sex differences in the neurological outcome . MAIN RESULTS AND THE ROLE OF CHANCE The fluency score , NOS and the prevalence of complex MND were similar in COH-IVF , MNC-IVF and Sub-NC children . The neurological condition of children born to subfertile parents was similar to that of children of fertile parents and was independent of the underlying cause of subfertility . No statistically significant associations were found between TTP and the fluency score and NOS . However , a positive correlation was found between TTP and the prevalence of complex MND ( TTP in years , adjusted odds ratio [ OR ] [ 95 % confidence interval , CI ] : 1.207 [ 1.038 to 1.404 ] , P = 0.014 ) ; a correlation which could be attributed to girls , in whom an evident positive correlation was present ( adjusted OR [ 95 % CI ] : 1.542 [ 1.161 to 2.047 ] , P = 0.003 ) . A similar association was absent in boys . LIMITATIONS , REASONS FOR CAUTION The prospect i ve design of our study and small post-natal attrition rate ( 9.3 % ) reduced potential selection bias based on the child 's development or health . The assessors were blind to the mode of conception , except for the group of children born to fertile parents , which was newly recruited . The study lacks sufficient power to conclude firmly that increased TTP is associated with a higher prevalence of complex MND . WIDER IMPLICATION S OF THE FINDINGS Our study suggests that the severity of subfertility , rather than its simple presence or components of IVF treatment , affects the neurological outcome . Moreover , girls may be neurologically more vulnerable for the effect of severity of subfertility . The finding that the severity of subfertility may be the decisive factor rather than the presence of a history of subfertility per se corro
Output:
| Growth , vision , and hearing of ICSI and SC offspring also appear comparable , although important differences in general physical health , and particularly metabolic and reproductive health have been described , including recently poorer semen quality among ICSI-conceived young adult men compared to SC peers .
Whilst neurodevelopment , growth , vision , and hearing appear similar between ICSI and SC children , evidence suggests differences in general physical health , and metabolic and reproductive endpoints . |
MS212173 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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***EXAMPLES***
Input: The presence of group-B streptococci in the urine of pregnant women seems to be associated with preterm labour . Urine sample s from 4122 women at 27 - 31 weeks ' gestation were examined for bacteria . Group-B streptococci were found in the urine of 69 women . In a double-blind , controlled study these patients were given either penicillin ( 10(6 ) IU three times daily for 6 days ; 37 patients ) or placebo ( 32 patients ) . The rates of primary rupture of the membranes ( 11 % v 53 % ; p less than 0.001 ) and preterm labour ( 5.4 % v 38 % ; p less than 0.002 ) were significantly lower in the penicillin group than in the placebo group . These results suggest that treatment and follow-up to prevent recolonisation in pregnant women with group-B streptococci in the urine may reduce the frequency of preterm labour in these patients BACKGROUND Existing approaches for the screening and treatment of asymptomatic bacteriuria in pregnancy are based on trials that were done more than 30 years ago . In this study , we reassessed the consequences of treated and untreated asymptomatic bacteriuria in pregnancy . METHODS In this multicentre prospect i ve cohort study with an embedded r and omised controlled trial , we screened women ( aged ≥18 years ) at eight hospitals and five ultrasound centres in the Netherl and s with a singleton pregnancy between 16 and 22 weeks ' gestation for asymptomatic bacteriuria . Screening was done with a single dipslide and two culture media . Dipslides were judged positive when the colony concentration was at least 1 × 10(5 ) colony-forming units ( CFU ) per mL of a single microorganism or when two different colony types were present but one had a concentration of at least 1 × 10(5 ) CFU per mL. Asymptomatic bacteriuria-positive women were eligible to participate in the r and omised controlled trial comparing nitrofurantoin with placebo treatment . In this trial , participants were r and omly assigned 1:1 to receive either nitrofurantoin 100 mg or identical placebo tablets , and were instructed to self-administer these tablets twice daily for 5 consecutive days . R and omisation was done by a web-based application with a computer-generated list with r and om block sizes of two , four , or six participants rendered by an independent data manager . 1 week after the end of treatment , they provided us with a follow-up dipslide . Women , treating physicians , and research ers all remained unaware of the bacteriuria status and treatment allocation . Women who refused to participate in the r and omised controlled trial did not receive any antibiotics , but their outcomes were collected for analysis in the cohort study . We compared untreated and placebo-treated asymptomatic bacteriuria-positive women with asymptomatic bacteriuria-negative women and nitrofurantoin-treated asymptomatic bacteriuria-positive women . The primary endpoint was a composite of pyelonephritis with or without preterm birth at less than 34 weeks , analysed by intention to treat at 6 weeks post-partum . This trial is registered with the Dutch Trial Registry , number NTR3068 . FINDINGS Between Oct 11 , 2011 , and June 10 , 2013 , we enrolled 5621 women into our screening cohort , of whom 5132 were eligible for screening . After exclusions for contaminated dipslides and patients lost to follow-up , in our final cohort of 4283 women , 248 were asymptomatic bacteriuria positive , of whom 40 were r and omly assigned to nitrofurantoin and 45 to placebo for the r and omised controlled trial , whereas the other 163 asymptomatic bacteriuria-positive women were followed without treatment . The proportion of women with pyelonephritis , preterm birth , or both did not differ between untreated or placebo-treated asymptomatic bacteriuria-positive women and asymptomatic bacteriuria-negative women ( 6 [ 2·9 % ] of 208 vs 77 [ 1·9 % ] of 4035 ; adjusted odds ratio [ OR ] 1·5 , 95 % CI 0·6 - 3·5 ) nor between asymptomatic bacteriuria-positive women treated with nitrofurantoin versus those who were untreated or received placebo ( 1 [ 2·5 % ] of 40 vs 6 [ 2·9 % ] of 208 ; risk difference -0·4 , 95 % CI -3·6 to 9·4 ) . Untreated or placebo-treated asymptomatic bacteriuria-positive women developed pyelonephritis in five [ 2·4 % ] of 208 cases , compared with 24 [ 0·6 % ] of 4035 asymptomatic bacteriuria-negative women ( adjusted OR 3·9 , 95 % CI 1·4 - 11·4 ) . INTERPRETATION In women with an uncomplicated singleton pregnancy , asymptomatic bacteriuria is not associated with preterm birth . Asymptomatic bacteriuria showed a significant association with pyelonephritis , but the absolute risk of pyelonephritis in untreated asymptomatic bacteriuria is low . These findings question a routine screen-treat-policy for asymptomatic bacteriuria in pregnancy . FUNDING ZonMw ( the Netherl and s Organisation for Health Research and Development ) A screening programme for the detection of asymptomatic bacteriuria in patients attending an antenatal clinic is described . The results obtained from the use of urinary antiseptics in a controlled trial over a period of two years are presented . The number of patients developing clinical pyelonephritis , fetal maturity at delivery and birth weight were recorded for treatment and control groups and compared with the equivalent results obtained from the total population of patients seen at the clinic The first part consisted of a prospect i ve study dealing with a series of 170 pregnancies during which cyto-bacteriological examination of urine was carried out in the 3rd , 5th , 7th and 9th months of pregnancy . Whenever bacteriuria was found it was treated . Those women found to be infected in pregnancy were re-examined bacteriologically and radiologically after delivery . A control series consisted of 200 pregnant women whose urines were not examined in this way unless they had clinical signs . In the first series 39 out of 170 women had at least one positive cyto-bacteriological test . 56 out of 638 examinations were abnormal . 50 had asymptomatic bacteriuria . No patient had any sign of acute pyelonephritis . In the control series 16 of the women had at least one positive cyto-bacteriological test . In all 21 tests were carried out ( 18 before signs of cystitis developed and 3 before symptoms of acute pyelonephritis ) . Treating asymptomatic bacteriuria is worth while because it helps to lower the incidence of pyelonephritis . There did not seem to be any relationship between premature labour , fetal mortality and maternal urinary pathology . Tests carried out at two definite intervals in pregnancy would seem to be a sufficient screening for preventing pyelonephritis and would be acceptable from the cost angle Although asymptomatic bacteriuria during pregnancy is associated with an increased risk of developing pyelonephritis , the effectiveness of screening programs to reduce this risk is controversial . A sharp reduction in the annual incidence of pyelonephritis ( 1.8 % to 0.6 % , P < .001 ) occurred after the introduction of a program to screen and treat asymptomatic bacteriuria among pregnant women followed at a large teaching hospital . The data provide retrospective and prospect i ve evidence that screening and treatment programs for asymptomatic bacteriuria during pregnancy reduce the risk of pyelonephritis in a population with a moderate to high prevalence of bacteriuria The incidence of impaired renal concentrating ability in pregnant women with asymptomatic significant bacteriuria is significantly less than previously reported when osmolality readings are performed on every urine specimen obtained during the 24 hours ' deprivation of fluids . The concentrating defect is more considerable as pregnancy progresses . The lower the maximum urinary osmolality the more difficult is the treatment of the patient , and the higher the incidence of acute pyelonephritis Although it has been shown that bacteriuria of pregnancy can be eradicated by keeping patients on antibacterial agents throughout pregnancy [ 1 ] , this regimen of treatment would be unacceptable to most individuals , particularly when asymptomatic ; and there are many who would question the ethical justification for such prolonged antibacterial therapy in pregnancy . This paper presents the results of a study design ed to determine whether antibacterial therapy of limited duration would eradicate
Output:
| Women have conflicting opinions about antibiotic use during pregnancy .
Antibiotic treatment for women having significant bacteriuria likely reduces the incidence of pyelonephritis and low birth weight , but we are uncertain about the magnitude of the effect and about the extent to which we can apply these results to asymptomatic population s and screening programmes . |
MS212174 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Although the benefits of antihypertensive treatment in " young " elderly ( under 70 years ) hypertensive patients are well established , the value of treatment in older patients ( 70 - 84 years ) is less clear . The Swedish Trial in Old Patients with Hypertension ( STOP-Hypertension ) was a prospect i ve , r and omised , double-blind , intervention study set up to compare the effects of active antihypertensive therapy ( three beta-blockers and one diuretic ) and placebo on the frequency of fatal and non-fatal stroke and myocardial infa rct ion and other cardiovascular death in hypertensive Swedish men and women aged 70 - 84 years . We recruited 1627 patients at 116 health centres throughout Sweden , who were willing to participate , and who met the entry criteria of three separate recordings during a 1-month placebo run-in period of systolic blood pressure between 180 and 230 mm Hg with a diastolic pressure of at least 90 mm Hg , or a diastolic pressure between 105 and 120 mm Hg irrespective of the systolic pressure . The total duration of the study was 65 months and the average time in the study was 25 months . 812 patients were r and omly allocated active treatment and 815 placebo . The mean difference in supine blood pressure between the active treatment and placebo groups at the last follow-up before an endpoint , death , or study termination was 19.5/8.1 mm Hg . Compared with placebo , active treatment significantly reduced the number of primary endpoints ( 94 vs 58 ; p = 0.0031 ) and stroke morbidity and mortality ( 53 vs 29 ; p = 0.0081 ) . Although we did not set out to study an effect on total mortality , we also noted a significantly reduced number of deaths in the active treatment group ( 63 vs 36 ; p = 0.0079 ) . The benefits of treatment were discernible up to age 84 years . We conclude that antihypertensive treatment in hypertensive men and women aged 70 - 84 confers highly significant and clinical ly relevant reductions in cardiovascular morbidity and mortality as well as in total mortality Neuroendocrine activation is known to occur in patients with congestive heart failure , but there is uncertainty as to whether this occurs before or after the presence of overt symptoms . In the Studies of Left Ventricular Dysfunction ( SOLVD ) , a multicenter study of patients with ejection fractions of 35 % or less , we compared baseline plasma norepinephrine , plasma renin activity , plasma atrial natriuretic factor , and plasma arginine vasopressin in 56 control subjects , 151 patients with left ventricular dysfunction ( no overt heart failure ) , and 81 patients with overt heart failure before r and omization . Median values for plasma norepinephrine ( p = 0.0001 ) , plasma atrial natriuretic factor ( p less than 0.0001 ) , plasma arginine vasopressin ( p = 0.006 ) , and plasma renin activity ( p = 0.03 ) were significantly higher in patients with left ventricular dysfunction than in normal control subjects . Neuroendocrine values were highest in patients with overt heart failure . Plasma renin activity was normal in patients with left ventricular dysfunction without heart failure who were not receiving diuretics and was significantly increased ( p less than 0.05 ) in patients on diuretic therapy . We conclude that neuroendocrine activation occurs in patients with left ventricular dysfunction and no heart failure . Neuroendocrine activation is further increased as overt heart failure ensues and diuretics are added to therapy The diuretic and clinical efficacy and safety of piretanide , a new high‐ceiling loop diuretic , was determined in patients with mild to moderately severe congestive heart failure . Piretanide ( n = 20 ) administered orally in a daily dosage of up to 24 mg was compared with placebo ( n = 18 ) for 28 days , using a double‐blind , r and omized , parallel design . Patients were hospitalized during the first 5 days of the study when dosage titration was established and 24‐hour fractionated urine collection s were obtained . Piretanide caused significant diuresis for 3 hours after ingestion with a natriuretic response noted for up to 6 hours . While occasional kaliuretic response was noted , it did not significantly increase 24‐hour urinary potassium excretion . Only one patient treated with the highest allowed dose of piretanide developed mild hypokalemia . An improvement in New York Heart Association functional class status was noted after piretanide therapy . In contrast , patients who received placebo exhibited no significant improvement . BUN increased in nine piretanide‐treated patients ; two were discontinued from the study because of progressive azotemia . However , there was no significant increase in serum creatinine levels . Other blood , physical , ECG , and audiometrie examinations also revealed no significant abnormalities . The study suggests that oral piretanide is a relatively safe and effective diuretic for treating congestive heart failure with a potential advantage of having potassium‐sparing properties Background Ten chronic heart failure patients were studied on three occasions in r and omized double-blind fashion to compare the acute hemodynamic , neurohormonal , and renal sodium-h and ling responses to 1 mg captopril versus 25 mg captopril , both in the absence of loop diuretic therapy and during furosemide-stimulated natriuresis . Methods and Results Compared with placebo , 1 mg captopril caused nonsignificant decreases in mean arterial pressure and circulating angiotensin II level and had no effect on glomerular filtration rate as determined by 51Cr-EDTA elimination . Captopril ( 25 mg ) produced marked suppression of serum angiotensin II with or without oral furosemide ( both p < 0.002 ) , a marked decrease in mean arterial pressure ( p < 0.0001 ) that was accentuated by furosemide ( p < 0.00001 ) , and a decrease in glomerular filtration rate ( p = 0.0007 ) . No difference from placebo in renal sodium excretion was noted with either 1 or 25 mg captopril in the absence of furosemide . In contrast , while 25 mg captopril caused slight attenuation of the natriuretic response to furosemide , 1 mg captopril significantly enhanced furosemideinduced natriuresis ( p < 0.05 ) . No correlation was found in our patients between the natriuretic effect of furosemide and either absolute mean arterial pressure or change in mean arterial pressure during the furosemide phase of each study session . This suggests that blood pressure is not the important factor mediating the divergent renal responses to furosemide of the two captopril dosage regimens . Conclusions We propose that in the face of furosemide-induced postglomerular vasodilatation in chronic heart failure , captopril at a starting dose of 1 mg ( but not 25 mg ) preserves enough circulating angiotensin II to maintain efferent arteriolar tone and thus glomerular filtration , while off setting the antinatriuretic renal tubular effects of angiotensin II BACKGROUND The RALES study showed that spironolactone , added to conventional therapy for chronic heart failure , dramatically reduced mortality . We tested the hypothesis that this benefit was partially due to improvement in endothelial function and /or to amplified suppression of the vascular renin-angiotensin axis . METHODS AND RESULTS We performed a r and omized , placebo-controlled , double-blind crossover study on 10 patients with NYHA class II to III chronic heart failure on st and ard diuretic/ACE inhibitor therapy , comparing 50 mg/d spironolactone ( 1 month ) versus placebo . Forearm vasculature endothelial function was assessed by bilateral forearm venous occlusion plethysmography using acetylcholine and N-monomethyl-L-arginine ( L-NMMA ) , with sodium nitroprusside as a control vasodilator . Also , vascular ACE activity was assessed by use of angiotensin ( Ang ) I , with Ang II as a control vasoconstrictor . Spironolactone significantly increased the forearm blood flow response to acetylcholine ( percentage change in forearm blood flow [ mean+/-SEM ] , 177+/-29 % versus 95+/-20 % , spironolactone versus placebo ; P<0.001 ) , with an associated increase in vasoconstriction due to L-NMMA ( -35+/-6 % versus -18+/-4 % ; P<0.05 ) . The Ang I response was also significantly reduced with spironolactone ( P<0.05 ) , with Ang II responses unaltered . CONCLUSIONS Spironolactone improves endothelial dysfunction , increases NO bioactivity , and inhibits vascular Ang I/Ang II conversion in patients with heart failure , providing novel mechanisms for its beneficial effect on cardiovascular mortality Background — In patients with chronic heart failure ( CHF ) , a β-blocker is generally added to a regimen containing an angiotensin-converting-enzyme ( ACE ) inhibitor . It is unknown whether β-blockade as initial therapy may be as useful . Methods and Results — We r and omized 1010 patients with mild to moderate CHF and left ventricular ejection fraction ≤35 % , who were not receiving ACE inhibitor , β-blocker , or angiotensin receptor blocker therapy , to open-label monotherapy with either bisoprolol ( target dose 10 mg QD ; n=505 ) or enalapril ( target dose 10 mg BID ; n=505 ) for 6 months , followed by their combination for 6 to 24 months . The 2 strategies were blindly compared with regard to the combined primary end point of all-cause mortality or hospitalization and with regard to each of these end point components individually . Bisoprolol-first treatment was noninferior to enalapril-first treatment if the upper limit of the 95 % confidence interval ( CI ) for the absolute between-group difference was < 5 % , corresponding to a hazard ratio ( HR ) of 1.17 . In the intention-to-treat sample , the primary end point occurred in 178 patients allocated to bisoprolol-first treatment versus 186 allocated to enalapril-first treatment ( absolute difference −1.6 % , 95 % CI −7.6 to 4.4 % , HR 0.94 ; 95 % CI 0.77 to 1.16 ) . In the per- protocol sample , 163 patients allocated to bisoprolol-first treatment had a primary end point , versus 165 allocated to enalapril-first treatment ( absolute difference −0.7 % , 95 % CI −6.6 to 5.1 % , HR 0.97 ; 95 % CI 0.78 to 1.21 ) . With bisoprolol-first treatment , 65 patients died , versus 73 with enalapril-first treatment ( HR 0.88 ; 95 % CI 0.63 to 1.22 ) , and 151 versus 157 patients were hospitalized ( HR 0.95 ; 95 % CI 0.76 to 1.19 ) . Conclusion — Although noninferiority of bisoprolol-first versus enalapril-first treatment was not proven in the per- protocol analysis , our results indicate that it may be as safe and efficacious to initiate treatment for CHF with bisoprolol as with enalapril AIMS It is reported that one third of patients with heart failure have normal left ventricular systolic function , and may or may not have left ventricular diastolic dysfunction . We sought to define the prevalence of left ventricular diastolic filling abnormalities in a large unselected group of patients , unlike the diagnosis by exclusion in the small highly selected groups of patients studied previously . METHODS AND RESULTS Patients were referred by general practitioners to an open-access echocardiography service for assessment of possible heart failure . Echocardiography included a Doppler study of transmitral flow at the tips of the mitral leaflets and calculation of an E/A ratio . Of 534 patients referred and assessed , 371 patients had normal systolic function and a measurable E/A ratio . These were compared with age-adjusted reference ranges to give 9 above the reference range and 19 below . This is only 10 more than would be expected if our patients were normal . In the same group of patients we found 96 cases of left ventricular systolic dysfunction , or 52 amongst the 423 with a measurable E/A ratio . CONCLUSION Either left ventricular diastolic filling abnormalities are very much less common than previously supposed or the E/A ratio is almost useless for their detection OBJECTIVES We sought to determine whether non-potassium-sparing diuretics ( PSDs ) in the absence of a PSD may result in progressive heart failure ( HF ) . BACKGROUND Angiotensin-converting enzyme ( ACE ) inhibitors incompletely suppress ACE activity in HF patients . Furthermore , non-PSDs are activators of aldosterone secretion . We reasoned that non-PSDs , in the absence of a PSD , might result in progressive HF . METHODS In the 6,797 patients in the Studies Of Left Ventricular Dysfunction ( SOLVD ) , we compared the risk of hospitalization for , or death from , HF
Output:
| The available data from several small trials show that in patients with chronic heart failure , conventional diuretics appear to reduce the risk of death and worsening heart failure compared to placebo .
Compared to active control , diuretics appear to improve exercise capacity |
MS212175 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: To determine the accuracy of the bibliographic citations in theJournal of Anesthesia , all references appearing the years 1987 ( Vol . 1;n=548 ) and 1994 ( Vol . 8;n=1839 ) were sequentially numbered and 100 references from each year were r and omly selected . After citations of non-journal articles were excluded ( n=8 in 1987;n=7 in 1994 ) , the remaining 185 citations were scrutinized . The authors ' names , article title , journal title , volume number , page numbers , and year were examined for each reference . A reference was deemed correct if each clement of the citation was identical to its source . Of the references examined , 41 % and 42 % in 1987 and 1994 , respectively , contained one or more errors . The elements that were inaccurate most often were , in descending order of frequency , article title , author , and page number . No significant differences existed in the error rate between the two years . We have demonstrated a considerable level of citation error in the reference lists of theJournal of Anesthesia articles , and no improvement over the last seven years . We recommend that contributors to theJournal of Anesthesia should carefully check the accuracy of their reference listings Consent forms in research are a source of current and retrospective information for the subject , a " prompt " for the person who is obtaining consent , and a documentation of the " informed " consent process and its adequacy . Occasionally , these forms may be administered by inexperienced trainees or ancillary personnel , and thus st and virtually alone . Therefore , the forms must be inherently comprehensible to the subjects . To test whether this is the case , 65 new applications were r and omly selected from 13 consecutive IRB agendas , and their consent documents were computer-analyzed ( Flesch/Fry scoring ) after correction for expected confounding features , such as lists , tables , and polysyllabic proper names and jargon . Mean U.S. school grade for 70 % comprehension ( Fry score ) was 15.03 + /- 0.19 ( st and ard error of the mean ) , implying readability by 37.4 + /- 1 % of the U.S. adult population . In contrast , a consecutive sampling of 21 Ann L and ers columns yielded a mean Fry score of 7.67 + /- 0.5 ( p < 0.01 ; readable by 75 + /- 3 % ) . Fifteen Reader 's Digest articles yielded a mean Fry score of 9.95 + /- 0.65 ( p < 0.01 ; readable by 59.1 + /- 3 % ) , and 15 " Talk of the Town " columns from The New Yorker averaged a grade level of 13.3 + /- 0.83 ; p < 0.01 ; readable by 42.7 % + /- 4.8 % ) . No document was improved by more than one grade level by the IRB review process , and most were unchanged . ( ABSTRACT TRUNCATED AT 250 WORDS To determine the accuracy of bibliographic citation in Acta Anaesthesiologica Sc and inavica . We review ed all 1990 volumes and part of 1994 volumes of the journal and sequentially numbered all references appearing in those years ( n = 2701 and 2158 in 1990 ( No. 1‐No . 8) and 1994 ( No. 1‐No . 5 ) , respectively ) . We r and omly selected 100 references from each year . After citations of nonjournal articles were excluded , the remaining 195 citations were carefully scrutinized . Authors ' names , article title , journal title , volume number , page numbers , and year w7ere examined in each selected reference . A reference was deemed correct if each element of the citation was identical to its source . Of the examined references , 40 % and 45 % contained one or more errors in 1 990 and 1994 , respectively . The elements most likely to be inaccurate were , in descending order of frequency , article title , author , and page number . No significant differences existed in the error rate between the two years . We have found many citation errors in the reference lists of Acta Anaesthesiologica Sc and inavica and no improvement in these latest four years . All contributors to Acta Anaesthesiologica Sc and inavica should thoroughly check the accuracy of reference lists OBJECTIVE To assess and compare the quality of nonstructured and structured abstract s of original research articles in three medical journals . DESIGN Blind , criterion-based observational study . SAMPLE R and om sample of 300 abstract s ( 25 abstract s per journal each year ) of articles published in the British Medical Journal ( BMJ ) , the Canadian Medical Association Journal and the Journal of the American Medical Association ( JAMA ) in 1988 and 1989 ( nonstructured abstract s ) and in 1991 and 1992 ( structured abstract s ) . MAIN OUTCOME MEASURES The quality of abstract s was measured against 33 objective criteria , which were divided into eight categories ( purpose , research design , setting , subjects , intervention , measurement of variables , results and conclusions ) . The quality score was determined by dividing the number of criteria present by the number applicable ; the score varied from 0 to 1 . RESULTS The overall mean quality scores for nonstructured and structured abstract s were 0.57 and 0.74 respectively ( p < 0.001 ) . The frequency in meeting the specific criteria was generally higher for the structured abstract s than for the nonstructured ones . The mean quality score was higher for nonstructured abstract s in JAMA than for those in BMJ ( 0.60 v. 0.54 , p < 0.05 ) . The scores for structured abstract s did not differ significantly between the three journals . CONCLUSIONS The findings support recommendations that promote the use of structured abstract s. Further studies should be performed to assess the effect of time on the quality of abstract s and the extent to which abstract s reflect the content of the articles CONTEXT The section of a research article most likely to be read is the abstract , and therefore it is particularly important that the abstract reflect the article faithfully . OBJECTIVE To assess abstract s accompanying research articles published in 6 medical journals with respect to whether data in the abstract could be verified in the article itself . DESIGN Analysis of simple r and om sample s of 44 articles and their accompanying abstract s published during 1 year(July 1 , 1996-June 30 , 1997 ) in each of 5 major general medical journals ( Annals of Internal Medicine , BMJ , JAMA , Lancet , and New Engl and Journal of Medicine ) and a consecutive sample of 44 articles published during 15 months ( July 1 , 1996-August 15 , 1997 ) in the CMAJ . MAIN OUTCOME MEASURE Abstract s were considered deficient if they contained data that were either inconsistent with corresponding data in the article 's body ( including tables and figures ) or not found in the body at all . RESULTS The proportion of deficient abstract s varied widely ( 18%-68 % ) and to a statistically significant degree ( P<.001 ) among the 6 journals studied . CONCLUSIONS Data in the abstract that are inconsistent with or absent from the article 's body are common , even in large-circulation general medical journals ABSTRACT Background : We compared the quality of structured abstract s of original research articles from the British Medical Journal ( BMJ ) , Canadian Medical Association Journal ( CMAJ ) , and the Journal of the American Medical Association ( JAMA ) from 1991 to 1992 and 2001 to 2002 and between journals . Methods : A r and om , stratified sample of 54 abstract s from 2001 to 2002 in BMJ , CMAJ , and JAMA was compiled and coded . Two blinded raters review ed 27 abstract s each against 33 objective criteria , separated into eight categories ( purpose , research design , setting , subjects , intervention , measurement of variables , results , and conclusion ) . The quality score was the proportion of criteria present ( range = 0–1 ) . Results : The overall mean quality score ( 0.74 ) for 2001–2002 was significantly higher than the 1988–1989 unstructured abstract s ( mean = 0.57 ; p < 0.001 ) but not different from the 1991–1992 structured abstract s ( mean = 0.74 ; p > 0.05 ) . In 2001–2002 , abstract s of CMAJ and JAMA ( both means = 0.76 ) improved significantly over 1991–1992 ( p < 0.05 ) and scored significantly higher than BMJ ( mean = 0.71 ; d.f . = 16 , p < 0.05 ) . Some individual criteria scores ( intervention , statistical information ) improved but information was found consistently under-represented in areas that imply shortcomings of the studies . Interpretation : We found a consistency in abstract quality regardless of the precise format used by different journals . This indicates that the framework for research articles already in place should be maintained and further modification of the framework may not necessarily improve the abstract quality Publication of medical research has high stakes : the communication and legitimization of medical research , the advancement of authors ' careers , priorities in funding decisions , the direction of future research , and the visibility and prestige of journals themselves . Peer review and editing play central roles in the publication process , affecting the acceptance of a manuscript and the form in which it appears . The most commonly heard justification of peer review is that it is an indispensable aid to an editor in assessing the importance of a scientific question and in assessing how well that question has been answered [ 1 , 2 ] . However , it has also been criticized as being inherently conservative , censorial , and , perhaps worst of all , arbitrary [ 3 ] . A frequently heard charge is that peer review delays the dissemination of crucial medical information without commensurate benefit [ 4 - 7 ] . During the last several years , some medical journal editors decided that the value of peer- review and editing practice s should be examined with the same rigor dem and ed for testing medical hypotheses [ 8 , 9 ] . The First International Congress on Peer Review was organized in 1989 [ 10 ] , bringing together medical journal editors and other interested scholars to present and discuss research on peer review ; a second Congress was held in 1993 . The peer- review process has two components : the assessment s by external review ers and the decisions and actions taken by editors , which are partially affected by comments from the review ers . To our knowledge , no study has evaluated the effects of peer review and editing on manuscript quality once the decision to accept has been made , and a computerized search of Index Medicus back to 1966 failed to locate any such studies . In this paper , we present the results of such a study , assessing the change in a manuscript between the times of provisional acceptance and final publication . We studied whether the quality of accepted manuscripts was improved by peer- review and editorial processes and , if it was , which aspects were most improved . Methods Setting The study was conducted at the editorial offices of Annals of Internal Medicine . Annals , a specialty journal in internal medicine , is published twice monthly and has a circulation of approximately 100 000 . Annals receives approximately 2400 manuscripts annually , of which half are reports of original research . During the period of this study , the investigators included the editors of Annals ( RHF and SWF ) and a statistical associate editor ( SNG ) . The Review Process No change was noted in the usual review and editing procedures at Annals during the time of this study . All manuscripts received at Annals were initially review ed by one of two full-time editors or one of two half-time deputy editors , as well as by one of seven associate editors , all of whom are faculty members of medical schools in Philadelphia and have subspecialty interests ( for example , infectious disease , gastroenterology ) . Half of the su bmi ssions were returned to authors without further review and half were sent to at least 2 outside review ers , selected by the associate editor from a data base of about 7000 review ers . After comments from the review ers were received , the original editor and associate editor reassessed each manuscript and chose which ones would be discussed at a weekly editorial conference of editors , deputy editors , medical associate editors , and two statistical associate editors . Factors that affected acceptance decisions included the quality of the research , the importance of the question , the contribution of the finding to its field , the utility and interest for Annals readers , the quality of the presentation , the priority relative to other articles , and available space . Authors were notified either that the editors would not accept the paper , that the editors were willing to reconsider the paper after major revisions , or that the paper was provisionally accepted , pending satisfactory revision . Approximately one third of the articles evaluated by outside review ers were accepted , 15 % of su bmi tted original research articles . Papers to be considered further were sent to authors , along with the comments of the two outside review ers , comments of one of the statistical editors , and a letter from one of the editors or deputy editors ( which summarized the discussion at the weekly conference , the ideas of the associate editor , and suggestions from the editor ) . In addition , each manuscript was review ed by a production editor , and directions for changes in manuscript wording or layout of figures and tables were included . All revised manuscripts were review ed by the editor or deputy editor in charge of the manuscript , the appropriate associate editor , the statistical editor , and the production editor . Some revised manuscripts were also reassessed by the original outside review ers . Approximately half of the revised manuscripts were returned to authors for further revision . Most revised manuscripts ( > 95 % ) were ultimately published . The time taken by this process was approximately 2 weeks for the initial decision to review or reject , 8 additional weeks to review and make an acceptance decision , 8 weeks until final acceptance , and about 4 months until publication . More than 95 % of manuscripts su bmi tted to Annals had a provisional acceptance or rejection decision sent to the authors within 3 months . The average time from su bmi ssion to publication was about 7 months , with initial peer
Output:
| More intensive editorial processes were associated with fewer errors in abstract s and references .
Structuring generally improved the quality of abstract s , but increased their length .
Surprisingly few studies have evaluated the effects of technical editing rigorously .
However there is some evidence that the ' package ' of technical editing used by biomedical journals does improve papers .
A substantial number of references in biomedical articles are cited or quoted inaccurately |
MS212176 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: BACKGROUND Patients with metastatic colorectal cancer that harbors KRAS mutations in exon 2 do not benefit from anti-epidermal growth factor receptor ( EGFR ) therapy . Other activating RAS mutations may also be negative predictive biomarkers for anti-EGFR therapy . METHODS In this prospect ive-retrospective analysis , we assessed the efficacy and safety of panitumumab plus oxaliplatin , fluorouracil , and leucovorin ( FOLFOX4 ) as compared with FOLFOX4 alone , according to RAS ( KRAS or NRAS ) or BRAF mutation status . A total of 639 patients who had metastatic colorectal cancer without KRAS mutations in exon 2 had results for at least one of the following : KRAS exon 3 or 4 ; NRAS exon 2 , 3 , or 4 ; or BRAF exon 15 . The overall rate of ascertainment of RAS status was 90 % . RESULTS Among 512 patients without RAS mutations , progression-free survival was 10.1 months with panitumumab-FOLFOX4 versus 7.9 months with FOLFOX4 alone ( hazard ratio for progression or death with combination therapy , 0.72 ; 95 % confidence interval [ CI ] , 0.58 to 0.90 ; P=0.004 ) . Overall survival was 26.0 months in the panitumumab-FOLFOX4 group versus 20.2 months in the FOLFOX4-alone group ( hazard ratio for death , 0.78 ; 95 % CI , 0.62 to 0.99 ; P=0.04 ) . A total of 108 patients ( 17 % ) with nonmutated KRAS exon 2 had other RAS mutations . These mutations were associated with inferior progression-free survival and overall survival with panitumumab-FOLFOX4 treatment , which was consistent with the findings in patients with KRAS mutations in exon 2 . BRAF mutations were a negative prognostic factor . No new safety signals were identified . CONCLUSIONS Additional RAS mutations predicted a lack of response in patients who received panitumumab-FOLFOX4 . In patients who had metastatic colorectal cancer without RAS mutations , improvements in overall survival were observed with panitumumab-FOLFOX4 therapy . ( Funded by Amgen and others ; PRIME Clinical Trials.gov number , NCT00364013 . ) BACKGROUND Cetuximab , an IgG1 chimeric monoclonal antibody against epidermal growth factor receptor ( EGFR ) , has activity against colorectal cancers that express EGFR . METHODS From December 2003 to August 2005 , 572 patients who had colorectal cancer expressing immunohistochemically detectable EGFR and who had been previously treated with a fluoropyrimidine , irinotecan , and oxaliplatin or had contraindications to treatment with these drugs underwent r and omization to an initial dose of 400 mg of cetuximab per square meter of body-surface area followed by a weekly infusion of 250 mg per square meter plus best supportive care ( 287 patients ) or best supportive care alone ( 285 patients ) . The primary end point was overall survival . RESULTS In comparison with best supportive care alone , cetuximab treatment was associated with a significant improvement in overall survival ( hazard ratio for death , 0.77 ; 95 % confidence interval [ CI ] , 0.64 to 0.92 ; P=0.005 ) and in progression-free survival ( hazard ratio for disease progression or death , 0.68 ; 95 % CI , 0.57 to 0.80 ; P<0.001 ) . These benefits were robust after adjustment in a multivariable Cox proportional-hazards model . The median overall survival was 6.1 months in the cetuximab group and 4.6 months in the group assigned to supportive care alone . Partial responses occurred in 23 patients ( 8.0 % ) in the cetuximab group but in none in the group assigned to supportive care alone ( P<0.001 ) ; the disease was stable in an additional 31.4 % of patients assigned to cetuximab and in 10.9 % of patients assigned to supportive care alone ( P<0.001 ) . Quality of life was better preserved in the cetuximab group , with less deterioration in physical function and global health status scores ( both P<0.05 ) . Cetuximab treatment was associated with a characteristic rash ; a rash of grade 2 or higher was strongly associated with improved survival ( hazard ratio for death , 0.33 ; 95 % CI , 0.22 to 0.50 ; P<0.001 ) . The incidence of any adverse event of grade 3 or higher was 78.5 % in the cetuximab group and 59.1 % in the group assigned to supportive care alone ( P<0.001 ) . CONCLUSIONS Cetuximab improves overall survival and progression-free survival and preserves quality -of-life measures in patients with colorectal cancer in whom other treatments have failed . ( Clinical Trials.gov number , NCT00079066 [ Clinical Trials.gov ] . ) Summary Background Therapeutic antibodies targeting EGFR have activity in advanced colorectal cancer , but results from clinical trials are inconsistent and the population in which most benefit is derived is uncertain . Our aim was to assess the addition of panitumumab to irinotecan in pretreated advanced colorectal cancer . Methods In this open-label , r and omised trial , we enrolled patients who had advanced colorectal cancer progressing after fluoropyrimidine treatment with or without oxaliplatin from 60 centres in the UK . From December , 2006 until June , 2008 , molecularly unselected patients were recruited to a three-arm design including irinotecan ( control ) , irinotecan plus ciclosporin , and irinotecan plus panitumumab ( IrPan ) groups . From June 10 , 2008 , in response to new data , the trial was amended to a prospect ively stratified design , restricting panitumumab r and omisation to patients with KRAS wild-type tumours ; the results of the comparison between the irinotcan and IrPan groups are reported here . We used a computer-generated r and omisation sequence ( stratified by previous EGFR targeted therapy and then minimised by centre , WHO performance status , previous oxaliplatin , previous bevacizumab , previous dose modifications , and best previous response ) to r and omly allocate patients to either irinotecan or IrPan . Patients in both groups received 350 mg/m2 intravenous irinotecan every 3 weeks ( 300 mg/m2 if aged ≥70 years or a performance status of 2 ) ; patients in the IrPan group also received intravenous panitumumab 9 mg/kg every 3 weeks . The primary endpoint was overall survival in KRAS wild-type patients who had not received previous EGFR targeted therapy , analysed by intention to treat . Tumour DNA was pyrosequenced for KRASc.146 , BRAF , NRAS , and PIK3CA mutations , and predefined molecular subgroups were analysed for interaction with the effect of panitumumab . This study is registered , number IS RCT N93248876 . Results Between Dec 4 , 2006 , and Aug 31 , 2010 , 1198 patients were enrolled , of whom 460 were included in the primary population of patients with KRASc.12–13,61 wild-type tumours and no previous EGFR targeted therapy . 230 patients were r and omly allocated to irinotecan and 230 to IrPan . There was no difference in overall survival between groups ( HR 1·01 , 95 % CI 0·83–1·23 ; p=0·91 ) , but individuals in the IrPan group had longer progression-free survival ( 0·78 , 0·64–0·95 ; p=0·015 ) and a greater number of responses ( 79 [ 34 % ] patients vs 27 [ 12 % ] ; p<0·0001 ) than did individuals in the irinotecan group . Grade 3 or worse diarrhoea ( 64 [ 29 % ] of 219 patients vs 39 [ 18 % ] of 218 patients ) , skin toxicity ( 41 [ 19 % ] vs none ) , lethargy ( 45 [21]% vs 24 [ 11 % ] ) , infection ( 42 [ 19 % ] vs 22 [ 10 % ] ) and haematological toxicity ( 48 [ 22 % ] vs 27 [ 12 % ] ) were reported more commonly in the IrPan group than in the irinotecan group . We recorded five treatment-related deaths , two in the IrPan group and three in the irinotecan group . Interpretation Adding panitumumab to irinotecan did not improve the overall survival of patients with wild-type KRAS tumours . Further refinement of molecular selection is needed for substantial benefits to be derived from EGFR targeting agents . Funding Cancer Research UK , Amgen
Output:
| The choice of an anti-EGFR MoAb as first-line biologic is a valid option in RAS wild-type patients c and i date to a doublet with infusional 5-FU . |
MS212177 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: BACKGROUND Idiopathic pulmonary fibrosis ( IPF ) is a progressive lung disease with pulmonary vasculopathy . OBJECTIVE The purpose of this study was to determine whether sildenafil improves 6-min walk distance ( 6MWD ) in subjects with IPF and right ventricular dysfunction . METHODS The IPFnet , a network of IPF research centers in the United States , conducted a r and omized trial examining the effect of sildenafil on 6MWD in patients with advanced IPF , defined by carbon monoxide diffusing capacity < 35 % predicted . A sub study examined 119 of 180 r and omized subjects where echocardiograms were available for independent review by two cardiologists . Right ventricular ( RV ) hypertrophy ( RVH ) , right ventricular systolic dysfunction ( RVSD ) , and right ventricular systolic pressure ( RVSP ) were assessed . Multivariable linear regression models estimated the relationship between RV abnormality , sildenafil treatment , and changes in 6MWD , St. George 's Respiratory Question naire ( SGRQ ) , the EuroQol instrument , and SF-36 Health Survey ( SF-36 ) from enrollment to 12 weeks . RESULTS The prevalence of RVH and RVSD were 12.8 % and 18.6 % , respectively . RVSP was measurable in 71 of 119 ( 60 % ) subjects ; mean RVSP was 42.5 mm Hg . In the subgroup of subjects with RVSD , subjects treated with sildenafil experienced less decrement in 6MWD ( 99.3 m ; P = .01 ) and greater improvement in SGRQ ( 13.4 points ; P = .005 ) and EuroQol visual analog scores ( 17.9 points ; P = .04 ) than subjects receiving placebo . In the subgroup with RVH , sildenafil was not associated with change in 6MWD ( P = .13 ) , but was associated with greater relative improvement in SGRQ ( 14.8 points ; P = .02 ) vs subjects receiving placebo . Sildenafil treatment in those with RVSD and RVH was not associated with change in SF-36 . CONCLUSIONS Sildenafil treatment in IPF with RVSD results in better preservation of exercise capacity as compared with placebo . Sildenafil also improves quality of life in subjects with RVH and RVSD Pulmonary hypertension is a life-threatening complication of lung fibrosis . Vasodilator therapy is difficult owing to systemic side effects and pulmonary ventilation-perfusion mismatch . We compared the effects of intravenous prostacyclin and inhaled NO and aerosolized prostacyclin in r and omized order and , in addition , tested for effects of oxygen and systemic calcium antagonists ( CAAs ) in eight patients with lung fibrosis and pulmonary hypertension . Aerosolized prostagl and in (PG)I2 caused preferential pulmonary vasodilatation with a decrease in mean pulmonary arterial pressure from 44.1 + /- 4.2 to 31.6 + /- 3.1 mmHg , and pulmonary vascular resistance ( RL ) from 810 + /- 226 to 386 + /- 69 dyn.s.cm-5 ( p < 0.005 , respectively ) . Systemic arterial pressure , arterial oxygen saturation , and pulmonary right-to-left-shunt flow , measured by multiple inert gas analysis , were not significantly changed . Inhaled NO similarly result ed in selective pulmonary vasodilatation , with RL decreasing from 726 + /- 217 to 458 + /- 81 dyn.s.cm-5 . In contrast , both intravenous PGI2 and CAAs were not pulmonary selective , result ing in a significant drop in arterial pressure . In addition PGI2 infusion caused a marked increase in shunt flow . Long-term therapy with aerosolized iloprost ( long-acting PGI2 analog ) result ed in unequivocal clinical improvement from a state of immobilization and severe resting dyspnea in a patient with decompensated right heart failure . We concluded that , in pulmonary hypertension secondary to lung fibrosis , aerosolization of PGI2 or iloprost causes marked pulmonary vasodilatation with maintenance of gas exchange and systemic arterial pressure . Long-term therapy with inhaled iloprost may be life saving in decompensated right heart failure from pulmonary hypertension secondary to lung fibrosis RATIONALE A previous trial of bosentan in idiopathic pulmonary fibrosis ( IPF ) showed a trend to delayed IPF worsening or death . Also , improvements in some measures of dyspnea and health-related quality of life were observed . OBJECTIVES To demonstrate that bosentan delays IPF worsening or death . METHODS Prospect i ve , r and omized ( 2:1 ) , double-blind , placebo-controlled , event-driven , parallel-group , morbidity-mortality trial of bosentan in adults with IPF of less than 3 years ' duration , confirmed by surgical lung biopsy , and without extensive honeycombing on high-resolution computed tomography . The primary endpoint was time to IPF worsening ( a confirmed decrease from baseline in FVC ≥ 10 % and diffusing capacity of the lung for carbon monoxide ≥ 15 % , or acute exacerbation of IPF ) or death up to End of Study . Effects of bosentan on health-related quality of life , dyspnea , and the safety and tolerability of bosentan were investigated . MEASUREMENTS AND MAIN RESULTS Six hundred sixteen patients were r and omized to bosentan ( n=407 ) or placebo ( = 209 ) . No significant difference between treatment groups was observed in the primary endpoint analysis ( hazard ratio , 0.85 ; 95 % confidence interval , 0.66 - 1.10 ; P=0.2110 ) . No treatment effects were observed on health-related quality of life or dyspnea . Some effects of bosentan treatment were observed in changes from baseline to 1 year in FVC and diffusing capacity of the lung for carbon monoxide . The safety profile for bosentan was similar to that observed in other trials . CONCLUSIONS The primary objective in the Bosentan Use in Interstitial Lung Disease-3 trial was not met . Bosentan was well tolerated . Clinical trial registered with www . clinical trials.gov ( NCT 00391443 ) Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of an intervention to be underestimated or overestimated . The Cochrane Collaboration ’s tool for assessing risk of bias aims to make the process clearer and more The aim of this study was to prospect ively evaluate the prevalence of pulmonary hypertension ( PH ) in patients with idiopathic pulmonary fibrosis ( IPF ) . One hundred thirty-nine patients ( 101 male , mean age = 68.6 ± 9 years ) , with confirmed IPF and who were admitted to eight Pulmonary Departments in Greece between November 2005 and December 2006 were included in the study . Pulmonary artery systolic pressure ( PASP ) was estimated by echocardiography , and PH was defined as PASP > 36 mmHg . We compared demographics , pulmonary function tests , NYHA functional status , 6-min walk distance ( 6MWD ) , B-type natriuretic peptide ( BNP ) , PaO2 , and P(A-a)O2 at rest data between patients with PH and without PH ( PASP ≤ 36 mmHg ) . Increased estimated right ventricular systolic pressure was present in 55 % of patients ( mean PASP = 47.1 ± 11.2 mmHg vs. 30.3 ± 3.8 mmHg , respectively ) . Patients with PH had a lower but not statistically significant DLCO ( 47.1 ± 18.8 vs. 52.5 ± 20.1 ) , lower PaO2 at rest ( 64.6 ± 12.2 vs. 71.1 ± 11.3 , P = 0.004 ) , and lower mean 6MWD ( 282 ± 118 vs. 338 ± 91 , P = 0.007 ) . Significant differences were also observed in the NYHA functional status between the two groups ( P = 0.02 ) . Statistically significant correlations were observed between PASP and PaO2 at rest ( r = −0.331 , P = 0.00 ) , P(A-a)O2 at rest ( r = 0.494 , P = 0.00 ) , 6MWD ( r = −0.264 , P = 0.01 ) , SpO2 at rest ( r = −0.293 , P = 0.00 ) , SpO2 at the end of exercise ( r = −0.364 , P = 0.00 ) , and also BNP values ( r = 0.319 , P = 0.01 ) . Moreover , PaO2 ( P = 0.02 ) , P(A-a)O2 ( P = 0.005 ) , and SpO2 at the end of exercise ( P = 0.023 ) were independent predictors of the presence of estimated PH . Using Doppler echocardiography as a screening tool for the estimation of PH , we found that PH is common in patients with IPF . Gas exchange parameters at rest and exercise desaturation might indicate underlying PH in IPF Idiopathic pulmonary fibrosis is a progressive , fatal disease . This prospect i ve , r and omised , double-blind , multicentre , parallel-group , placebo-controlled phase II trial ( NCT00903331 ) investigated the efficacy and safety of the endothelin receptor antagonist macitentan in idiopathic pulmonary fibrosis . Eligible subjects were adults with idiopathic pulmonary fibrosis of <3 years duration and a histological pattern of usual interstitial pneumonia on surgical lung biopsy . The primary objective was to demonstrate that macitentan ( 10 mg once daily ) positively affected forced vital capacity versus placebo . Using a central ised system , 178 subjects were r and omised ( 2:1 ) to macitentan ( n=119 ) or placebo ( n=59 ) . The median change from baseline up to month 12 in forced vital capacity was -0.20 L in the macitentan arm and -0.20 L in the placebo arm . Overall , no differences between treatments were observed in pulmonary function tests or time to disease worsening or death . Median exposures to macitentan and placebo were 14.5 months and 15.0 months , respectively . Alanine and /or aspartate aminotransferase elevations over three times upper limit of normal arose in 3.4 % of macitentan-treated subjects and 5.1 % of placebo recipients . In conclusion , the primary objective was not met . Long-term exposure to macitentan was well tolerated with a similar , low incidence of elevated hepatic aminotransferases in each treatment group . Long-term exposure to macitentan was well tolerated in IPF in a trial that did not meet its primary end-point Pulmonary hypertension is a life-threatening complication of lung fibrosis . Vasodilator therapy is difficult owing to systemic side effects and pulmonary ventilation-perfusion mismatch . We compared the effects of intravenous prostacyclin and inhaled NO and aerosolized prostacyclin in r and omized order and , in addition , tested for effects of oxygen and systemic calcium antagonists ( CAAs ) in eight patients with lung fibrosis and pulmonary hypertension . Aerosolized prostagl and in (PG)I(2 ) caused preferential pulmonary vasodilatation with a decrease in mean pulmonary arterial pressure from 44.1 + /- 4.2 to 31.6 + /- 3.1 mm Hg , and pulmonary vascular resistance ( RL ) from 810 + /- 226 to 386 + /- 69 dyn . s. cm(-)(5 ) ( p < 0.05 , respectively ) . Systemic arterial pressure , arterial oxygen saturation , and pulmonary right-to-left shunt flow , measured by multiple inert gas analysis , were not significantly changed . Inhaled NO similarly result ed in selective pulmonary vasodilatation , with RL decreasing from 726 + /- 217 to 458 + /- 81 dyn . s. cm(-)(5 ) . In contrast , both intravenous PGI(2 ) and CAAs were not pulmonary selective , result ing in a significant drop in arterial pressure . In addition , PGI(2 ) infusion caused a marked increase in shunt flow . Long-term therapy with aerosolized iloprost ( long-acting PGI(2 ) analog ) result ed in unequivocal clinical improvement from a state of immobilization and severe resting dyspnea in a patient with decompensated right heart failure . We concluded that , in pulmonary hypertension secondary to lung fibrosis , aerosolization of PGI(2 ) or iloprost causes marked pulmonary vasodilatation with maintenance of gas exchange and systemic arterial pressure . Long-term therapy with inhaled iloprost may be life saving in decompensated right heart failure from pulmonary hypertension secondary to lung fibrosis The clinical course of pulmonary hypertension ( PH ) in idiopathic pulmonary fibrosis ( IPF ) is not known except in advanced disease
Output:
| We found no significant changes from baseline in lung function , dyspnea , or exercise capacity .
Although PH-specific agents provided small health-related quality -of-life benefits , our meta- analysis provides insufficient evidence to support their use in IPF patients |
MS212178 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: This multicenter , prospect i ve , double-blind study compared the safety and efficacy of clindamycin and ciprofloxacin versus ceftriaxone and doxycycline in the treatment of out patients with mild to moderate pelvic inflammatory disease ( PID ) diagnosed by laparoscopy . Sample s taken from the endocervix , endometrium , and abdominal cavity before treatment and from the endocervix after treatment were cultured for aerobes , anaerobes , Neisseria gonorrhoeae , and Chlamydia trachomatis . Of the 138 patients enrolled , 131 were evaluable for efficacy . The most prevalent bacteria were streptococci , staphylococci , and Escherichia coli ( among aerobes ) and Bacteroides species and peptostreptococci ( among anaerobes ) . N. gonorrhoeae was present in 2 % ( 3 ) of the 131 evaluable patients , and C. trachomatis was in 11 % ( 15 ) . The clinical cure rate was 97 % ( 65 of 67 ) in the clindamycin and ciprofloxacin group and 95 % ( 61 of 64 ) in the ceftriaxone and doxycycline group . Side effects were similar in both groups . In conclusion , the two regimens for the outpatient treatment of mild to moderate PID were similarly effective and safe Eighty-two patients with laparoscopically confirmed salpingitis were r and omly divided into two groups in a multicentre and prospect i ve trial . Single drug therapy with the amoxicillin-clavulanic acid combination was used in 42 patients ( group A ) . The other 40 patients were given a combination of penicillin , aminoside and metronidazole ( group B ) . For each case a secondary prescription for a tetracycline was discussed . Clinical results were comparable in both groups : sooner ( at the end of the hospitalization period ) in group A : 10 cured , 30 improved and 2 failures against 9 cured , 30 improved in group B. Later ( evaluation after 5 to 8 weeks ) a relapse was noted in five patients in group A and included one case of angioedema in group B. It is concluded that amoxicillin-clavulanic acid combination is a satisfactory alternative to the penicillin-aminoside-metronidazole combination , especially as it is simpler to use Objective : This multinational , multicentre , prospect i ve , r and omised , double blind , parallel group , non-inferiority study compared the efficacy and safety of moxifloxacin monotherapy with ofloxacin plus metronidazole in women with uncomplicated pelvic inflammatory disease . Methods : Women from hospitals throughout 13 countries received a 14 day course of either oral moxifloxacin , 400 mg once daily ( n = 384 ) , or oral ofloxacin , 400 mg twice daily plus oral metronidazole , 500 mg twice daily ( n = 365 ) . Results : Of the 741 patients in the intent to treat ( ITT ) population , 564 ( 74.2 % ) were valid for the per protocol ( PP ) analyses ; 112 ( 19.9 % ) of these were included in the microbiologically valid population ( MBV ) . Clinical resolution rates in the PP population at the test of cure visit ( TOC , 5–24 days post-therapy , primary efficacy end point ) were 90.2 % ( 248/275 ) for moxifloxacin and 90.7 % ( 262/289 ) for ofloxacin plus metronidazole ( 95 % CI : −5.7 % to 4.0 % ) . At follow up ( 28–42 days post-therapy ) , resolution rates in the PP population were 85.8 % ( 236/275 ) and 87.9 % ( 254/289 ) for moxifloxacin and comparator , respectively ( 95 % CI : −8.0 % to 3.1 % ) . Bacteriological success rates in the MBV population at TOC were 87.5 % ( 49/56 ) for moxifloxacin and 82.1 % ( 46/56 ) for comparator ( 95 % CI : −8.3 % to 18.8 % ) . Against Chlamydia trachomatis and Neisseria gonorrhoeae , bacteriological success rates with moxifloxacin were 88.5 % ( 23/26 ) and 100 % ( 13/13 ) and for comparator 85.7 % ( 18/21 ) and 81.8 % ( 18/22 ) , respectively . Drug related adverse events occurred less frequently with moxifloxacin ( 22.5 % ( 85/378 ) ) versus the comparator ( 30.9 % ( 112/363 ) ) ( p = 0.01 ) . Conclusion : In uncomplicated PID , once daily moxifloxacin monotherapy was clinical ly and bacteriologically as efficacious as twice daily ofloxacin plus metronidazole therapy and was associated with fewer drug related adverse events Sixty patients with acute uncomplicated pelvic infection were treated with cefoxitin or ampicillin alone , the purpose being to show that a relatively cheap antimicrobial agent ( ampicillin ) could be used . The groups ( 30 patients in each ) were clinical ly comparable ( P greater than 0,01 - -Hotelling T-square test ) . In the first group 2 g ampicillin was administered intravenously on admission followed by 1 g intravenously 4-hourly , and in the second group 2 g cefoxitin was administered intravenously on admission followed by 1 g intravenously every 8 hours . A good response was obtained in both groups . On the basis of cost ampicillin would seem to be the treatment of choice in uncomplicated acute pelvic infection A prospect i ve , r and omized , controlled , non-blind clinical trial was conducted to compare the efficacy of monotherapy with ciprofloxacin with that of a combination of clindamycin plus gentamicin in the treatment of patients with acute pelvic inflammatory disease . Pretreatment and post-treatment cervical culture specimens were obtained for Neisseria gonorrhoeae , Chlamydia trachomatis , Mycoplasma hominis , and Ureaplasma urealyticum . Pretreatment and post-treatment endometrial culture specimens were obtained for those organisms plus facultative and anaerobic bacteria . Minimal inhibitory concentrations were determined on all isolates by agar dilution . Clinical resolution of infection was seen in 31 of 33 ( 94 percent ) ciprofloxacin-treated patients compared with 34 of 35 ( 97 percent ) clindamycin/gentamicin-treated patients . N. gonorrhoeae was eradicated in all cases and C. trachomatis in 12 of 13 cases ( 92 percent ) . Ciprofloxacin appeared less effective than clindamycin/gentamicin in eradicating bacterial-vaginosis-associated organisms from post-treatment culture specimens obtained from the endometrium . Comparable clinical response was seen with both regimens . The significance of persistent bacterial-vaginosis-associated organisms following ciprofloxacin therapy is unclear . However , since one goal of treatment of pelvic inflammatory disease should be to eliminate organisms from the upper genital tract , ciprofloxacin may not provide optimal single-agent therapy for pelvic inflammatory disease In this prospect i ve trial , 130 hospitalized patients with acute pelvic inflammatory disease based on clinical criteria were r and omly treated with intravenous gentamicin plus clindamycin ( N=63 ) or cefoxitin plus doxycycline ( N=67 ) for at least 4 days , followed by oral clindamycin or doxycycline , respectively , for a total of 14 days . Pre-treatment cultures were obtained for endocervical Neisseria gonorrhoeae and Chlamydia trachomatis , and for endometrial C trachomatis and aerobic and anaerobic bacteria . Overall , 46 subjects ( 35 % ) had endocervical cultures positive for N gonorrhoeae . Endocervical and endometrial cultures were positive for C trachomatis in 16 and 6 % , respectively . Ninety-five percent of patients had at least one aerobic bacterium , 38 % had at least one anaerobic bacterium , and only 2 % had no organisms isolated from their endometrium . Fifty-seven subjects taking gentamicin-clindamycin ( 90.5 % ) and 64 subjects taking cefoxitin-doxycycline ( 95.5 % ) were clinical ly cured , a nonsignificant difference . Three subjects treated with gentamicin- clindamycin and one treated with cefoxitindoxycycline required hysterectomy or salpingectomy for cure . Follow-up examinations and cultures were performed in 84 % of the subjects . Post-treatment cultures for N gonorrhoeae were negative in all cases tested . Post-treatment endocervical and endometrial C trachomatis cultures were negative in ten of 11 subjects treated with gentamicinclindamycin and in eight of nine treated with cefoxitindoxycycline , a nonsignificant difference . We conclude that gentamicin-clindamycin and cefoxitin-doxycycline have similar clinical cure rates for acute pelvic inflammatory disease and are equivalent in eradicating genital N gonorrhoeae and C A prospect i ve , r and omized study of intravenous followed by oral ciprofloxacin compared with the combination of intravenous clindamycin and gentamicin was conducted in 122 women hospitalized with pelvic infections . Clinical diagnoses included endometritis ( 97 patients ) and uncomplicated pelvic inflammatory disease ( 25 patients ) . Treatment successes for endometritis included 42 of 50 ( 84 percent ) patients treated with ciprofloxacin compared with 35 of 47 ( 75 percent ) treated with the clindamycin-gentamicin combination . Treatment successes for acute salpingitis included 10 of 10 ( 100 percent ) treated with ciprofloxacin and 13 of 15 ( 87 percent ) treated with clindamycin-gentamicin . Ciprofloxacin successfully eradicated Chlamydia trachomatis in 11 of 12 patients as did clindamycin-gentamicin in six of seven patients . In this study of pelvic infection , ciprofloxacin demonstrated efficacy comparable with the combination of clindamycin and gentamicin , and is effective against C. trachomatis Sixty-two women were r and omized in a double-blind fashion to receive one of two antibiotic regimens for the treatment of clinical ly diagnosed pelvic inflammatory disease . Thirty of .31 patients ( 96.8 % ) receiving a combination of cefoxitin with doxycycline and 28 of 31 ( 90.3 % ) receiving a combination of clindamycin with amikacin responded to therapy ( P = not significant ) . Chlamydia trachomatis , Neisseria gonorrhoea , or both were isolated from 13.3 , 7.0 , and 4.8 % of patients , respectively . Of the four patients not responding to therapy , all had inflammatory complexes . Cefoxitin/doxycycline and clindamycin/amikacin are both effective in the treatment of pelvic inflammatory disease This six-center , prospect i ve , open-label clinical trial compared the efficacy and safety of three regimens recommended by the Centers for Disease Control and Prevention ( CDC ) for the treatment of women hospitalized for acute pelvic inflammatory disease ( PID ) . The study focused on the response to inpatient therapy , not on long-term prevention of sequelae . A severity score was used for objective comparison of the degree of illness before and after therapy . Women were r and omly assigned ( in a 1:1:1 ratio ) to treatment with cefoxitin plus doxycycline , clindamycin plus gentamicin , or cefotetan plus doxycycline . Two hundred seventy-five ( 94.2 % ) of 292 evaluable women required no alteration in therapeutic regimen . The three regimens produced almost identical cure rates . No serious adverse clinical or laboratory events were observed . In short , the three regimens recommended by the CDC for inpatient therapy of acute PID were similarly effective and safe The vaginal douching habits of 100 consecutive municipal hospital patients with verified pelvic inflammatory disease ( cases ) were compared with those of 762 r and omly selected controls ( r and om controls ) and 119 women thought to have pelvic inflammatory disease but in whom the diagnosis was not confirmed by laparoscopy and /or endometrial biopsy specimen ( internal controls ) . Because patients had been symptomatic for no more than 3 weeks , current douching was arbitrarily defined as any douching during the previous 2 months . Current douching was more common among
Output:
| In this systematic review , we present information relating to the effectiveness and safety of the following interventions : antibiotics ( oral , parenteral , different duration s , different regimens ) and routine antibiotic prophylaxis ( before intrauterine device insertion in women at high risk or low risk ) |
MS212179 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Recent work has suggested that anhedonia in schizophrenia can be understood as involving two separate constructs : deficits in anticipatory and consummatory pleasure . Little is known about the relative stability of these different constructs and their links with clinical features and social function over time . To examine these questions , 51 participants with a diagnosis of schizophrenia or schizoaffective disorder in a non-acute phase of illness were administered the Temporal Experience of Pleasure Scale , the Positive and Negative Syndrome Scale , and Quality of Life Scale at two time points six months apart . Results revealed that baseline scores of both anticipatory and consummatory pleasure were significantly correlated with follow-up scores six months later , suggesting each construct is stable in the short term . The association of anticipatory pleasure at baseline and six months was significantly higher than the relationship between consummatory pleasure at baseline and at six months . Anticipatory pleasure predicted concurrent and prospect i ve levels of positive symptoms , emotional discomfort , and interpersonal function , but not emotion recognition . Consummatory pleasure predicted only concurrent positive symptoms . The link of baseline anticipatory pleasure with emotional discomfort at six months persisted even after controlling for baseline emotional discomfort . Implication s for the measurement and conceptualization of anhedonia in schizophrenia are discussed BACKGROUND Negative symptoms may be associated with dysfunction of the brain reward system in schizophrenia . We used functional magnetic resonance imaging ( fMRI ) to assess the BOLD response in the ventral striatum of unmedicated schizophrenics during presentation of reward-indicating and loss-indicating stimuli . METHODS A total of 10 schizophrenic men ( 7 never medicated , 3 unmedicated for at least 2 years ) and 10 age-matched healthy male volunteers participated in an incentive monetary delay task , in which visual cues predicted that a rapid response to a subsequent target stimulus would result either in monetary gain or loss or would have no consequence . RESULTS Compared to healthy controls , unmedicated schizophrenics showed reduced ventral striatal activation during the presentation of reward-indicating cues . Decreased activation of the left ventral striatum was inversely correlated with the severity of negative ( and trendwise positive ) symptoms . DISCUSSION Reduced activation in one of the central areas of the brain reward system , the ventral striatum , was correlated with the severity of negative symptoms in medication-free schizophrenics . In unmedicated schizophrenic patients , a high striatal dopamine turnover may increase the " noise " in the reward system , thus interfering with the neuronal processing of reward-predicting cues by phasic dopamine release . This , in turn , may contribute to negative symptoms as such as anhedonia , apathy , and loss of drive and motivation Background The Temporal Experience of Pleasure Scale ( TEPS ) is a measure specifically design ed to capture the anticipatory and consummatory facets of pleasure . However , few studies have examined the structure of the measure in non-Western sample s. The current study aim ed to evaluate the factor structure and psychometric properties of the TEPS in a Chinese sample . Methods We administered the Chinese version of the TEPS to 2275 healthy Chinese college students . They were r and omly split into two sub- sample s. The first sub- sample was used for exploratory factor analysis ( EFA ) to examine the structure of the TEPS in a Chinese sample . The second sub- sample was used as a validation sample for the identified structure from the EFA and confirmatory factor analysis ( CFA ) was adopted . Results Results of the EFA suggested a four-factor model ( consummatory context ual , consummatory abstract , anticipatory context ual , and anticipatory abstract factors ) instead of the original two-factor model ( consummatory and anticipatory factors ) ascertained from Western sample s in the United States . The CFA results confirmed these results in the second sub- sample . Internal consistency and test-retest stability of the TEPS factors were good . Conclusions The TEPS has four factors among Chinese participants . Possible reasons for cultural difference and potential applications of the TEPS for cross-cultural comparison are discussed Research on emotional processing in schizophrenia suggests relatively intact subjective responses to affective stimuli " in the moment . " However , neuroimaging evidence suggests diminished activation in brain regions associated with emotional processing in schizophrenia . We asked whether given a more vulnerable cognitive system in schizophrenia , individuals with this disorder would show increased or decreased modulation of working memory ( WM ) as a function of the emotional content of stimuli compared with healthy control subjects . In addition , we examined whether higher anhedonia levels were associated with a diminished impact of emotion on behavioral and brain activation responses . In the present study , 38 individuals with schizophrenia and 32 healthy individuals completed blocks of a 2-back WM task in a functional magnetic resonance imaging scanning session . Blocks contained faces displaying either only neutral stimuli or neutral and emotional stimuli ( happy or fearful faces ) , r and omly intermixed and occurring both as targets and non-targets . Both groups showed higher accuracy but slower reaction time for negative compared to neutral stimuli . Individuals with schizophrenia showed intact amygdala activity in response to emotionally evocative stimuli , but demonstrated altered dorsolateral prefrontal cortex ( DLPFC ) and hippocampal activity while performing an emotionally loaded WM-task . Higher levels of social anhedonia were associated with diminished amygdala responses to emotional stimuli and increased DLPFC activity in individuals with schizophrenia . Emotional arousal may challenge dorsal-frontal control systems , which may have both beneficial and detrimental influences . Our findings suggest that disturbances in emotional processing in schizophrenia relate to alterations in emotion-cognition interactions rather than to the perception and subjective experience of emotion per se CONTEXT Low-functioning patients with chronic schizophrenia have high direct treatment costs and indirect costs incurred due to lost employment and productivity and have a low quality of life ; antipsychotic medications and psychosocial interventions have shown limited efficacy to promote improved functional outcomes . OBJECTIVE To determine the efficacy of an 18-month recovery-oriented cognitive therapy program to improve psychosocial functioning and negative symptoms ( avolition-apathy , anhedonia-asociality ) in low-functioning patients with schizophrenia . Design , Setting , and PARTICIPANTS A single-center , 18-month , r and omized , single-blind , parallel group trial enrolled 60 low-functioning , neurocognitively impaired patients with schizophrenia ( mean age , 38.4 years ; 33.3 % female ; 65.0 % African American ) . INTERVENTIONS Cognitive therapy plus st and ard treatment vs st and ard treatment alone . MAIN OUTCOME MEASURES The primary outcome measure was the Global Assessment Scale score at 18 months after r and omization . The secondary outcomes were scores on the Scale for the Assessment of Negative Symptoms and the Scale for the Assessment of Positive Symptoms at 18 months after r and omization . RESULTS Patients treated with cognitive therapy showed a clinical ly significant mean improvement in global functioning from baseline to 18 months that was greater than the improvement seen with st and ard treatment ( within-group Cohen d , 1.36 vs 0.06 , respectively ; adjusted mean [ SE ] , 58.3 [ 3.30 ] vs 47.9 [ 3.60 ] , respectively ; P = .03 ; between-group d = 0.56 ) . Patients receiving cognitive therapy as compared with those receiving st and ard treatment also showed a greater mean reduction in avolition-apathy ( adjusted mean [ SE ] , 1.66 [ 0.31 ] vs 2.81 [ 0.34 ] , respectively ; P = .01 ; between-group d = -0.66 ) and positive symptoms ( hallucinations , delusions , disorganization ) ( adjusted mean [ SE ] , 9.4 [ 3.3 ] vs 18.2 [ 3.8 ] , respectively ; P = .04 ; between-group d = -0.46 ) at 18 months . Age was controlled in the analyses , and there were no meaningful group differences in baseline antipsychotic medications ( class or dosage ) or in medication changes during the course of the trial . CONCLUSION Cognitive therapy can be successful in promoting clinical ly meaningful improvements in functional outcome , motivation , and positive symptoms in low-functioning patients with significant cognitive impairment . Trial Registration clinical trials.gov Identifier : NCT00350883 BACKGROUND Cognitive difficulties are prevalent in people with a diagnosis of schizophrenia and are associated with poor long-term functioning . AIMS To evaluate the effectiveness of cognitive remediation therapy on cognitive difficulties experienced by people with schizophrenia . METHOD Participants with a diagnosis of schizophrenia , a social behaviour problem and a cognitive difficulty ( n=85 ) were r and omised to 40 sessions of cognitive remediation or treatment as usual in a single-blind r and omised controlled trial . Working memory , cognitive flexibility and planning , were measured at weeks 0,14 and 40 . RESULTS There were durable improvements in working memory ( advantage 1.33 points , 95 % CI 0.43 - 2.16 , st and ardised effect size 0.34 ) as well as an indication of improvement in cognitive flexibility . Memory improvement predicted improvement in social functioning . Costs were lower in the cognitive remediation group following therapy but rose at follow-up . However , cost-effectiveness analyses showed that improvements in memory were achieved at little additional cost . CONCLUSIONS Cognitive remediation therapy is associated with durable improvements in memory , which in turn are associated with social functioning improvements in people with severe mental illness Startle-elicited blinks were measured during the presentation of affective slides in order to investigate emotional responsiveness in 24 male healthy subjects and 34 male schizophrenic patients . Although the two groups did not differ with regard to their subjective and autonomic responses to the slide stimuli , there was a significant difference between the groups in their responses to the startle probes . Patients rated low in affective expression showed a linear response pattern comparable to that of normal controls with largest amplitudes during unpleasant slides and smallest during pleasant slides . Patients without apparent deficit in affective expression showed a quadratic relationship with smaller blink amplitudes during both pleasant and unpleasant slides . Diminished affective expression rated on the basis of a clinical interview is not associated with a general attenuation of the blink reflex or of its modulation by exposure to emotional slides . Thus , we found no indication of an impairment in the perception of affective stimuli nor of reduced appreciation of pleasant stimuli ( anhedonia ) in these patients A dysfunction of central dopaminergic neurotransmission has been found in various neuropsychiatric diseases , and may be associated with a common psychopathological correlate . One hypothesis suggests that dopaminergic stimulation of the brain reward system reinforces behavior because it is experienced as pleasurable , and that dopaminergic dysfunction leads to anhedonia , the inability to experience pleasure . An alternative hypothesis assumes that dopaminergic stimulation does not promote pleasure or " liking " of a reward but rather mediates " wanting " of a reward , and suggests that dopaminergic dysfunction is associated with a failure to be motivated by stimuli that indicate reward . We measured negative symptoms , psychomotor slowing and dopamine receptor sensitivity in twelve drug-free patients with major depression , seventeen alcohol-dependent and sixteen opiate-dependent patients , ten schizophrenics with neuroleptic medication , and ten healthy controls . The sensitivity of central dopamine receptors was assessed with the growth hormone response to apomorphine application . Psychomotor slowing was measured in a reaction-time test and anhedonia and other negative symptoms were assessed with self-rating scales and the Scale for the Assessment of Negative Symptoms . Patients with major depression , alcohol dependence and neuroleptic medication displayed a reduced sensitivity of central dopamine receptors compared to control subjects . Anhedonia was not a common correlate of dopamine receptor dysfunction . Instead , affective flattening was associated with both dopamine receptor sensitivity and psychomotor slowing . Our findings thus do not support the anhedonia hypothesis of central dopaminergic dysfunction . Rather , affective flattening may result from the lack of an emotional response towards reward-indicating stimuli . These findings indicate that patients with dopaminergic dysfunction are not unable to experience pleasure , but may fail to be motivated by environmental stimuli to seek reward
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| RESULTS 80 independent studies were review ed and executive functions , emotional memory and the translation of motivation into actions are highlighted as key deficits with a strong evidence base in people with schizophrenia . |
MS212180 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: Background Self-management programs for patients with heart failure can reduce hospitalizations and mortality . However , no programs have analyzed their usefulness for patients with low literacy . We compared the efficacy of a heart failure self-management program design ed for patients with low literacy versus usual care . Methods We performed a 12-month r and omized controlled trial . From November 2001 to April 2003 , we enrolled participants aged 30–80 , who had heart failure and took furosemide . Intervention patients received education on self-care emphasizing daily weight measurement , diuretic dose self-adjustment , and symptom recognition and response . Picture-based educational material s , a digital scale , and scheduled telephone follow-up were provided to reinforce adherence . Control patients received a generic heart failure brochure and usual care . Primary outcomes were combined hospitalization or death , and heart failure-related quality of life . Results 123 patients ( 64 control , 59 intervention ) participated ; 41 % had inadequate literacy . Patients in the intervention group had a lower rate of hospitalization or death ( crude incidence rate ratio ( IRR ) = 0.69 ; CI 0.4 , 1.2 ; adjusted IRR = 0.53 ; CI 0.32 , 0.89 ) . This difference was larger for patients with low literacy ( IRR = 0.39 ; CI 0.16 , 0.91 ) than for higher literacy ( IRR = 0.56 ; CI 0.3 , 1.04 ) , but the interaction was not statistically significant . At 12 months , more patients in the intervention group reported monitoring weights daily ( 79 % vs. 29 % , p < 0.0001 ) . After adjusting for baseline demographic and treatment differences , we found no difference in heart failure-related quality of life at 12 months ( difference = -2 ; CI -5 , + 9 ) . Conclusion A primary care-based heart failure self-management program design ed for patients with low literacy reduces the risk of hospitalizations or death Background Peak oxygen uptake ( VO2 ) testing is commonly used to assess chronic heart failure ( CHF ) patients ’ exercise tolerance . The test requires maximal effort ; however , many participants have low confidence ( self-efficacy ) to perform optimally . Purpose This r and omized controlled trial examined the effectiveness of a modeling intervention to increase Peak VO2 ( PVO2 ) and self-efficacy in people diagnosed with CHF . Methods Twenty participants with a diagnosis of CHF were r and omized to either an intervention ( modeling DVD ) or a control group . Both groups completed a measure of self-efficacy prior to performing two PVO2 tests , each separated by 7 days . After completing the first test ( T1 ) the intervention group watched a 10-min coping model DVD . All participants returned 1 week later ( T2 ) to complete identical study procedures . Results Analysis of covariance results showed that compared with the participants in the control group , those assigned to the modeling intervention had higher PVO2 at T2 , F ( 1 , 19 ) = 4.38 , p = 0.05 , ή2 = 0.21 and self-efficacy , F ( 1 , 19 ) = 5.80 , p < 0.05 , ή2 = 0.25 . Only partial support was found for change in self-efficacy mediating treatment outcome ( PVO2 ) . Conclusions Watching a modeling video is associated with increased PVO2 and self-efficacy . These results have implication s for testing patients in a clinical setting to maximize exercise tolerance test results OBJECTIVES This study evaluated the effectiveness ( changes in health behaviors , health status , and health service utilization ) of a self-management program for chronic disease design ed for use with a heterogeneous group of chronic disease patients . It also explored the differential effectiveness of the intervention for subjects with specific diseases and comorbidities . METHODS The study was a six-month r and omized , controlled trial at community-based sites comparing treatment subjects with wait-list control subjects . Participants were 952 patients 40 years of age or older with a physician-confirmed diagnosis of heart disease , lung disease , stroke , or arthritis . Health behaviors , health status , and health service utilization , as determined by mailed , self-administered question naires , were measured . RESULTS Treatment subjects , when compared with control subjects , demonstrated improvements at 6 months in weekly minutes of exercise , frequency of cognitive symptom management , communication with physicians , self-reported health , health distress , fatigue , disability , and social/role activities limitations . They also had fewer hospitalizations and days in the hospital . No differences were found in pain/physical discomfort , shortness of breath , or psychological well-being . CONCLUSIONS An intervention design ed specifically to meet the needs of a heterogeneous group of chronic disease patients , including those with comorbid conditions , was feasible and beneficial beyond usual care in terms of improved health behaviors and health status . It also result ed in fewer hospitalizations and days of hospitalization BACKGROUND Outcomes related to chronic heart failure ( HF ) remain relatively poor , despite advances in pharmacological therapy and medical and nursing care . Experts agree that outpatient care may be among the factors that affect HF outcomes . We hypothesized that the method by which outpatient care is delivered may affect outcomes in this patient population . METHODS A prospect i ve , r and omized design was used to compare HF outcomes from 216 patients r and omized to 1 of 2 home health care delivery methods for 3 months after discharge . Care was delivered by the home nurse visit ( HNV ) or the nurse telemanagement ( NTM ) method . In the latter , patients used transtelephonic home monitoring devices to measure their weight , blood pressure , heart rate , and oxygen saturation . These data were transmitted daily to a secure Internet site . An advanced- practice nurse worked collaboratively with a cardiologist and subsequently treated patients via the telephone . Both delivery methods used the same HF-specific clinical guidelines to direct care . Outcomes include HF readmissions and length of stay , anxiety , depression , self-efficacy , and quality of life . Data were primarily tested using a 2-group analysis of variance ( ANOVA ) . We used a repeated- measures ANOVA to conduct preintervention-postintervention analyses . RESULTS After 3 months , patients in the NTM group ( n = 108 ; mean + /- SD age , 62.9 + /- 13.2 years ; 83 % African American ; 64 % female ) had fewer HF readmissions ( 13 vs 24 ; P</=.001 ) with shorter lengths of stay ( 49.5 vs 105.0 days ; P</=.001 ) compared with the HNV group ( n = 108 ; mean + /- SD age , 63.2 + /- 12.6 years ; 89 % African American ; 62 % female ) . Hospitalization charges at 3 months were less in the NTM group compared with the HNV group ( $ 65 023 vs $ 177 365 ; P</=.02 ) . At 6 and 12 months , cumulative readmission charges in the NTM group were also less ( $ 223 638 vs $ 500 343 [ P<.03 ] and $ 541 378 vs $ 677 710 [ P</=.16 ] , respectively ) compared with the HNV group . Quality of life was significantly improved for both groups when we compared postintervention and preintervention scores . CONCLUSION The adaptation of state-of-the-art computerized technology to closely monitor patients with HF with advanced- practice nurse care under the guidance of a cardiologist significantly improves HF management while reducing the cost of care Nonadherence to medical treatment among heart failure patients is high and results in frequent exacerbations and premature death . This treatment-only pilot study examined whether a year-long group-based self-management intervention is feasible and improves self-management skills in patients with mild-to-moderate heart failure ( ejection fraction < or = 40 % and New York Heart Association functional class I , II , or III ) . A total of 31 of 100 recruited patients ( 31 % ) agreed to participate . Twenty-six ( 84 % ) completed the year-long self-management program . Compared with baseline , the intervention was associated with an increase in overall self-efficacy in practicing self-management skills ( p<0.001 ) and in four of five specific self-management skills . Patients and their group leaders also reported an increase in actual use of self-management skills ( p<0.001 ) and in several psychosocial outcomes . The success of this pilot study suggests the need for a r and omized clinical trial to test the efficacy of group-based self-management training on medical outcomes BACKGROUND Heart failure is a common and important cause of morbidity and mortality . Disease management offers promise in reducing the need for hospitalization and improving quality of life for heart failure patients , but experimental data on the efficacy of such programs are limited . METHODS AND RESULTS A total of 151 patients hospitalized with heart failure were r and omized to usual care or scheduled telephone calls by specially trained nurses promoting self-management and guideline -based therapy as prescribed by primary physicians . Nurses also screened patients for heart failure exacerbations , which they managed with supplemental diuretics or by contacting the primary physician for instructions . Outcomes included time to hospital encounter , mortality , number and cost of hospitalizations , functional status , and satisfaction with care . Intervention patients had a longer time to encounter ( hazard ratio [ HR ] = 0.67 ; 95 % confidence interval [ CI ] 0.47 - 0.96 ; P = .029 ) , hospital readmission ( HR = 0.67 ; CI 0.46 - 0.99 ; P = .045 ) , and heart failure-specific readmission ( HR = 0.62 ; CI 0.38 - 1.03 ; P = .063 ) . The number of admissions , hospital days , and hospital costs were significantly lower during the first 6 months after intervention but not at 1 year . The intervention had little effect on functional status , mortality , and satisfaction with care . CONCLUSION A nurse-administered , telephone-based disease management program delayed subsequent health care encounters , but had minimal impact on other outcomes OBJECTIVE Patients with heart failure need education and support to improve knowledge and self-care . Shared medical groups that provide education and support have been successful in other patient population s. This study compares an advanced practice nurse-led shared medical appointment intervention in the office setting with st and ard care relative to self-care and knowledge among community-living adults with heart failure . METHODS Participants were r and omized to shared appointment and st and ard care groups , and completed the Heart Failure Knowledge Test and Self-Care Heart Failure Index at baseline and 8 weeks . RESULTS From baseline to 8 weeks , Heart Failure Knowledge Test scores improved more for the intervention group than the control group ( F time X group = 4.90 , df = 1.21 ; P = .038 ) . There was no difference in groups ' rates of change on the total Self-Care Heart Failure Index . CONCLUSION The findings reveal improved knowledge when education and support are provided in a shared medical appointment setting . The shared medical visit model may be feasible as a way to provide patients with heart failure and their families with ongoing education and a supportive environment The purpose of this pilot study was to ( a ) determine the feasibility of providing a heart failure disease management program through an in-home telehealth communication device ( Health Buddy ® ) and ( b ) compare the effectiveness of the Health Buddy ® with traditional home management strategies ( telephonic , home visit ) in achieving selected patient outcomes ( self-efficacy , functional status , depression , and health-related quality of life ) . Ninety participants completed the study through 2 months . Thirty percent of participants were either eliminated prior to or withdrawn after enrollment from the study based on Health Buddy ® issues . A mixed model ANOVA revealed those who received telephonic disease management experienced decreased confidence in their ability to manage their heart failure whereas all other groups experienced increased confidence . Further ANOVA analyses indicated improvement over time with no group differences for functional status , depression , or health-related quality of life . These findings suggest that delivering a disease management program through a telehealth communication device is feasible and may be as effective as traditional methods BACKGROUND Self-management of dietary sodium restriction by persons with heart failure ( HF ) is difficult and usually occurs within the home setting and within a family context . OBJECTIVE To compare a patient and family education ( EDUC ) intervention with a combined education and family partnership intervention ( EDUC + FPI ) for effects on improving dietary sodium self-management in persons with HF . METHODS Patients with HF and a family member ( FM ) were r and omized to EDUC ( n = 29 dyads ) or EDUC + FPI ( n = 32 dyads ) . Participants with HF were primarily White males with a mean age of 61 years ( + /-12 ) . The FMs were primarily women and spouses and had a mean age of 54 years ( + /-17 ) . Self-reported dietary sodium ( Diet NA ) intake and 24-hr urinary sodium ( Urine NA ) were measured at baseline ( BL ) and 3 months ( 3 M ) after intervention . Data were analyzed with descriptive statistics , generalized least squares regression , paired t test , and chi-square test . RESULTS Groups did not differ by age , gender , or clinical variables ; however , family functioning ( Family APGAR ) scores were slightly higher in the EDUC + FPI group at BL . Both groups decreased Diet NA and Urine NA from BL to 3 M ; the EDUC + FPI group showed greater decrease in Urine NA and had a greater percentage of those who decreased Urine NA by at least 15 % ( p = .04 ) . Regression analysis to predict Urine NA revealed a significant Group x Time interaction ( p = .03 ) when accounting for time-varying measures of body mass index ( p = .001 ) . DISCUSSION
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| Both short- and long-term interventions can improve self-efficacy demonstrating that the duration of the intervention can vary and still be successful .
Existing evidence suggests that it is not the amount of education ( number of sessions/length of sessions ) that improves self-efficacy , but some other factor or factors that remain unknown at present . |
MS212181 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: AIM To explore incident cases of diagnosed diabetes over 35 years of follow-up in relation to self-perceived stress at baseline . METHODS This was a population -based r and om sample of 7251 men derived from the Primary Prevention Trial Study , aged 47 - 56 years at baseline and without prior history of diabetes , coronary heart disease and stroke . Incident diabetes was identified from hospital discharge and death registries as principal or secondary diagnosis . Cox proportional hazards regression was used to evaluate the potential association between stress and diabetes . RESULTS During a 35-year follow-up , a total of 899 men were identified with diabetes . The crude incidence was 5.2 per 1000 persons-years . At baseline , 15.5 % men reported permanent stress related to conditions at work or home . After adjusting for age and competing risk of death , the estimated 35-year conditional probability of diabetes in men with permanent stress was 42.6 % , compared with 31.0 % for those with periodic stress and 31.2 % with no stress . In age-adjusted Cox regression analysis , men with permanent stress had a higher risk of diabetes [ hazard ratio 1.52 ( 95 % CI 1.26 - 1.82 ) ] compared with men with no ( referent ) or periodic stress [ hazard ratio 1.09 ( 95 % CI 0.94 - 1.27 ) ] . The association between stress and diabetes was slightly attenuated but remained significant after adjustment for age , socio-economic status , physical inactivity , BMI , systolic blood pressure and use of anti-hypertensive medication [ hazard ratio 1.45 ( 95 % CI 1.20 - 1.75 ) ] . When examining principal diagnosis of diabetes cases separately from secondary diagnoses cases , the excess risk of diabetes associated with permanent stress remained significant both in age ( only ) and multivariable adjusted models . CONCLUSION Self-perceived permanent stress is an important long-term predictor of diagnosed diabetes , independently of socio-economic status , BMI and other conventional Type 2 diabetes risk factors A new cohort study links work-related stress to an increased risk of developing type 2 diabetes mellitus ( T2DM ) in women , but the findings are less clear in men . R and omized controlled studies are now needed to determine whether management of stress could be used to reduce the risk of developing T2DM BACKGROUND Social inequalities in the incidence of type 2 diabetes and the relation of health behaviors and psychosocial factors to the incidence of type 2 diabetes are not well established . METHODS Prospect i ve occupational cohort study of 10 308 civil servants aged 35 to 55 years at baseline in phase 1 ( 1985 - 1988 ) . Diagnosis of diabetes was ascertained by question naire at baseline and follow-up at phases 2 ( 1989 ) , 3 ( 1992 - 1993 ) , 4 ( 1995 ) , and 5 ( 1997 - 1999 ) and glucose tolerance tests in phases 3 and 5 . RESULTS Participants working in the lower employment grade s had a higher incidence of diabetes than those in higher employment grade s ( men : odds ratio [ OR ] , 2.9 ; 95 % confidence interval [ CI ] , 1.9 - 4.4 ; women : OR , 1.7 [ 95 % CI , 0.8 - 3.7 ] ) . Body mass index and other risk factors considered traditional for type 2 diabetes were found to be so in this cohort . In men , of the psychosocial risk factors examined , only effort-reward imbalance was related to incidence of diabetes ( OR , 1.7 [ 95 % CI , 1.0 - 2.8 ] ) . The General Health Question naire depression subscale was related to incidence of diabetes and impaired glucose tolerance ( OR , 1.25 [ 95 % CI , 1.0 - 1.6 ] ) . These associations remained after adjustment for other confounding factors . In men only , social difference in incidence of diabetes was reduced but still significant after adjustment for conventional risk factors . CONCLUSIONS An inverse relationship exists between social position and incidence of diabetes that is partly explained by health behaviors and other risk factors . Effort-reward imbalance , which is reportedly associated with coronary heart disease , is also associated with type 2 diabetes Positive energy balance is the major cause of obesity , and chronic stress may be a contributory factor . The authors examined cumulative work stress , using the Job Strain Question naire on four occasions , as a predictor of obesity in a prospect i ve 19-year study of 6,895 men and 3,413 women ( aged 35 - 55 years ) in the Whitehall II cohort in London , United Kingdom ( baseline : 1985 - 1988 ) . A dose-response relation was found between work stress and risk of general obesity ( body mass index > or = 30 kg/m(2 ) ) and central obesity ( waist circumference > 102 cm in men , > 88 cm in women ) that was largely independent of covariates . The imputed odds ratios of body mass index obesity for one , two , and three or more reports of work stress adjusted for age , sex , and social position were 1.17 , 1.24 , and 1.73 ( trend p < 0.01 ) , respectively . For waist obesity , the corresponding findings were 1.17 , 1.41 , and 1.61 ( trend p < 0.01 ) . Work stress effect was modestly attenuated after exclusion of obese individuals at baseline and further adjustments for smoking ; intakes of dietary fiber , fruits and vegetables , and alcohol ; and levels of physical activity during follow-up . This study provides prospect i ve , population -based evidence that chronic work stress predicts general and central obesity OBJECTIVES To determine whether men and women with repeated ERI exposure have increased BP means or higher hypertension incidence over a 3-year follow-up . To examine the potential modifying effect of age and overcommitment . METHODS The study cohort was composed of 1,595 white-collar workers ( 629 men and 966 women ) assessed at baseline and 3-year follow-up . Ambulatory BP measures were taken every 15 min during a working day . ERI at work was self-reported using vali date d scales . BP means at follow-up and cumulative incidence of hypertension were respectively modeled with analyses of covariance ( ANCOVA ) and log-binomial regression . RESULTS Among men , no association was observed between repeated ERI exposure and BP . Among women , age had a modifying effect . Women < 45 years old exposed to ERI at both times had significantly higher BP means at follow-up ( 122.2/78.9 mmHg ) than those unexposed ( 120.4/77.4 mmHg ) . In women ≥45 years old , the cumulative incidence of hypertension was 2.78 ( 95 % CI : 1.26 - 6.10 ) times higher among those exposed to ERI at both times . Men and women in the higher tertile of overcommitment had higher BP means ( men : 128.9/82.2 mmHg , women : 121.9/78.0 mmHg ) than those in the lower tertile ( men : 127.2/81.3 mmHg , women : 120.6/77.0 mmHg ) . CONCLUSION This prospect i ve study showed that , among women , repeated ERI exposure led to a significant age-specific increase in BP means and a major age-specific increase in hypertension incidence . These results suggest that primary intervention aim ed at reducing ERI may contribute to lower BP and prevent hypertension in women OBJECTIVES We evaluated whether cumulative exposure to job strain increases blood pressure . METHODS A prospect i ve study of 8395 white-collar workers was initiated during 1991 to 1993 . At follow-up , 7.5 years later , 84 % of the participants were reassessed to estimate cumulative exposure to job strain . RESULTS Compared with men who had never been exposed , men with cumulative exposure and those who became exposed during follow-up showed significant systolic blood pressure increments of 1.8 mm Hg ( 95 % confidence interval [CI]=0.1 , 3.5 ) and 1.5 mm Hg ( 95 % CI=0.2 , 2.8 ) , respectively , and relative risks of blood pressure increases in the highest quintile group of 1.33 ( 95 % CI = 1.01 , 1.76 ) and 1.40 ( 95 % CI = 1.14 , 1.73 ) . Effect magnitudes were smaller among women . Effects tended to be more pronounced among men and women with low levels of social support at work . CONCLUSIONS Among these white-collar workers , exposure to cumulative job strain had a modest but significant effect on systolic blood pressure among men . The risk was of comparable magnitude to that observed for age and sedentary behavior . Men and women with low levels of social support at work appeared to be at higher risk for increases in blood pressure OBJECTIVES We investigated whether exposure to negative aspects of close relationships was associated with subsequent increase in body mass index ( BMI ) and waist circumference . METHODS Data came from a prospect i ve cohort study ( Whitehall II ) of 9425 civil servants aged 35 to 55 years at baseline ( phase 1 : 1985 - 1988 ) . We assessed negative aspects of close relationships with the Close Persons Question naire ( range 0 - 12 ) at phases 1 and 2 ( 1989 - 1990 ) . We measured BMI and waist circumference at phases 3 ( 1991 - 1994 ) and 5 ( 1997 - 1999 ) . Covariates at phase 1 included gender , age , marital status , ethnicity , BMI , employment grade , smoking , physical activity , fruit and vegetable consumption , and common mental disorder . RESULTS After adjustment for sociodemographic characteristics and health behaviors , participants with higher exposure to negative aspects of close relationships had a higher likelihood of a 10 % or greater increase in BMI and waist circumference ( odds ratios per 1-unit increase 1.08 [ 95 % confidence interval ( CI ) = 1.02 , 1.14 ; P = .007 ] and 1.09 [ CI = 1.04 , 1.14 ; P ≤ .001 ] , respectively ) as well as a transition from the overweight ( 25 ≤ BMI < 30 ) to the obese ( BMI ≥ 0 ) category . CONCLUSIONS Adverse social relationships may contribute to weight gain Background Review s have shown that depression is a risk factor for the development of type 2 diabetes . However , there is limited evidence for general psychological distress to be associated with incident diabetes . The aim of the present study was to test whether persons who report higher levels of psychological distress are at increased risk to develop type 2 diabetes during 18 years follow up , adjusted for confounders . Methods A prospect i ve analysis using data from 9,514 participants ( 41 years , SD=14 ; 44 % men ) of the British Household Panel Survey . The General Health Question naire 12 item version was used to assess general psychological distress , diabetes was measured by means of self-report . Cox proportional hazards regression models were used to calculate the multivariate-adjusted hazard ratio ( HR ) of incident diabetes during 18 years follow up , comparing participants with low versus high psychological distress at baseline ( 1991 ) . Results A total of 472 participants developed diabetes 18 year follow up . Those with a high level of psychological distress had a 33 % higher hazard of developing diabetes ( HR=1.33 , 95 % CI 1.10–1.61 ) , relative to those with a low level of psychological distress , adjusted for age , sex , education level and household income . After further adjustment for differences in level of energy , health status , health problems and activity level , higher psychological distress was no longer associated with incident diabetes ( HR=1.10 , 95 % CI 0.91 - 1.34 ) . Conclusions Higher levels of psychological distress are a risk factor for the development of diabetes during an 18 year follow up period . This association may be potentially mediated by low energy level and impaired health status Two studies investigate the effect of stress on food choice . Experiment 1 demonstrates experimentally that stress causes changes in food choice away from healthy low fat foods ( grapes ) to less healthy high fat foods ( M&Ms ) , confirming previous survey research . Experiment 2 , a survey study , finds that more females than males report increasing food consumption when stressed . A much larger percentage of those who report increasing their food consumption when stressed ( 71 % ) are restrained eaters ( i.e. , dieters ) than are people who undereat or who do not change the amount they eat when stressed ( 35 % ) . The foods that they report overeating when stressed are foods they normally avoid for weight-loss or health reasons ( i.e. , highly caloric high fat snack foods ) . They report eating these foods to feel better . Both studies show that stress not only increases consumption in certain individuals but also shifts their food choice from lower fat to higher fat foods OBJECTIVE To investigate the prospect i ve influence of work stress on type 2 diabetes ( T2D ) . RESEARCH DESIGN AND METHODS This population -based cohort included 3,2
Output:
| Regarding the four elements of MES : i ) weight gain : the prospect i ve studies supported etiological roles for relationship stress , perceived stress , and distress , while the studies on work-related stress ( WS ) showed conflicting results ; ii ) dyslipidemi : too few studies on psychosocial stress as a risk factor for dyslipidemia were available to draw a conclusion ; however , a trend toward a positive association was present ; iii ) type 2 diabetes mellitus ( DM2 ) : prospect i ve studies supported perceived stress and distress as risk factors for the development of DM2 among men , but not among women , while WS was generally not supported as a risk factor among neither men nor women ; iv ) hypertension : marital stress and perceived stress might have an influence on blood pressure ( BP ) , while no association was found regarding distress .
Evaluating WS the results were equivocal and indicated that different types of WS affected the BP differently between men and women .
In conclusion , a longitudinal association between chronic psychosocial stress and the development of MES seems present . |
MS212182 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: The objective of this study was to investigate the relation between the peripheral concentrations of the adrenal steroid hormones cortisol and dehydroepi and rosterone sulfate ( DHEAS ) and cognitive impairment and decline . A prospect i ve study design was used . The setting was a suburb of Rotterdam , The Netherl and s. The study population consisted of a sample of 189 healthy participants from the population -based Rotterdam Study , aged 55 - 80 yr , who were invited for an additional examination . Follow-up examinations took place 1.9 yr after baseline , on the average . We determined fasting blood levels of DHEAS before dexamethasone administration and of cortisol and corticosteroid-binding globulin before and after the administration of 1 mg dexamethasone overnight . The 30-point Mini-Mental State Examination ( MMSE ) was used to assess cognition . The associations with cognitive impairment ( MMSE score of < 26 ; 6 % of the sample ) and cognitive decline ( drop in MMSE score of > 1 point/yr ; 24 % ) were estimated using logistic regression , with adjustment for age , sex , education , and depressive symptoms . An increase of 1 SD in the estimate of free cortisol ( SD = 30.3 ) was associated with cognitive impairment , although not significantly [ odds ratio ( OR ) = 1.5 ; 95 % confidence interval ( CI ) , 0.9 - 2.4 ] . A 1 SD increase in the natural logarithm of cortisol after the administration of 1 mg dexamethasone ( SD = 0.68 ) was associated with an OR for cognitive decline of 1.5 ( 95 % CI , 1.0 - 2.3 ) . A 1 SD increase in DHEAS ( SD = 2.10 micromol/L ) was inversely , but nonsignificantly , related to cognitive impairment ( OR = 0.5 ; 95 % CI , 0.2 - 1.1 ) and cognitive decline ( OR = 0.6 ; 95 % CI , 0.4 - 1.1 ) . The ratio of free cortisol over DHEAS was significantly related to cognitive impairment ( OR = 1.8 ; 95 % CI , 1.0 - 3.2 ) . This prospect i ve study among healthy elderly subjects suggested that basal free cortisol levels were positively related to cognitive impairment , and cortisol levels after dexamethasone treatment were related to cognitive decline . There was an inverse , but nonsignificant , association between DHEAS and cognitive impairment and decline BACKGROUND In humans , concentrations of the adrenal steroid hormone dehydroepi and rosterone ( DHEA ) and its sulfate ester ( DHEAS ) decline with age . Results from studies in rodents have suggested that DHEA administration can improve memory performance as well as neuronal plasticity . However , a first study from our laboratory could not demonstrate beneficial effects of DHEA substitution on cognitive performance and well-being in elderly subjects . To further evaluate whether DHEA replacement has effects on the central nervous system , an experiment using event-related potentials ( ERPs ) was conducted . METHODS In this placebo-controlled crossover study , 17 elderly men ( mean age , 71.1 + /- 1.7 yr ; range 59 - 81 yr ) took placebo or DHEA ( 50 mg/day ) for 2 weeks ( double blind ) . After each treatment period subjects participated in an auditory oddball paradigm with three oddball blocks . In the first two blocks subjects had to count the rare tone silently , whereas , in the third block they had to press a button . In addition , memory tests assessing visual , spatial , and semantic memory as well as question naires on psychological and physical well-being were presented . RESULTS Baseline DHEAS levels were lower compared with young adults . After 2-week DHEA replacement , DHEAS levels rose 5-fold to levels observed in young men . DHEA substitution modulated the P3 component of the ERPs , which reflects information updating in short-term memory . P3 amplitude was increased after DHEA administration , and only selectively in the second oddball block . DHEA did not influence P3 latency . Moreover , DHEA did not enhance memory or mood . CONCLUSIONS A 2-week DHEA replacement in elderly men results in changes in electrophysiological indices of central nervous system stimulus processing if the task is performed repeatedly . However , these effects do not appear to be strong enough to improve memory or mood Dehydroepi and rosterone ( DHEA ) and its sulfate form ( DHEAS ) have been the focus of considerable publicity because of their demonstrated associations with a broad range of health outcomes . Yet , knowledge about the effects of endogenous DHEA(S ) on health in humans is limited and often inconclusive , largely because few of the studies have been based on prospect i ve surveys of population -representative sample s. This analysis uses a national longitudinal survey in Taiwan to investigate whether DHEAS is associated with subsequent changes ( 2000 - 2003 ) in functional limitations , cognitive impairment , depressive symptoms , and global self-rated health . Regression models based on this older Taiwanese sample show that among men , lower levels of DHEAS are related to declines in mobility and self-assessed health status and increases in depressive symptoms , while both low and very high levels of DHEAS are associated with poor cognitive function . There are no significant associations among women . These findings differ from those in a previous cross-sectional analysis based on the Taiwan study and underscore the importance of using prospect i ve data to examine the effects of DHEAS on health . The evidence based on this and other longitudinal studies suggests that endogenous DHEAS is related to health outcomes for men , but not women , in both Western and non-Western population This study explores the potential relationship between a series of cognitive abilities and testosterone , dehydroepi and rosterone ( DHEA ) , and rostenedione , and body mass index ( BMI ) measurements in 5-year-old children . 60 boys and 69 girls were administered a test ( K-BIT ) which provided measurements of fluid intelligence ( Matrices subtest ) , crystallized intelligence ( Vocabulary subtest ) , and IQ composite ( the combination of the two subtests ) ; a sub- sample of 48 boys and 61 girls was also subjected to diverse tests related to theory of mind ( affective labeling , appearance-reality distinction , display rules , and false belief ) . Testosterone , DHEA , and and rostenedione levels were measured using an enzyme immunoassay technique in saliva sample s. An analysis of variance failed to reveal any significant differences between boys and girls in any of the cognitive abilities assessed . The correlation analysis revealed a positive relationship between fluid intelligence and testosterone levels in boys , a negative relationship between crystallized intelligence and and rostenedione levels in girls , and between affective labeling and and rostenedione levels in boys . A multiple regression analysis indicated that and rostenedione and BMI were the best predictors for some of the cognitive abilities assessed The levels of dehydroepi and rosterone ( DHEA ) and its sulfate ester DHEAS decrease with age after a peak around 25 yr . Animal studies as well as the first studies in humans have generated the idea that DHEA replacement in elderly subjects may have beneficial effects on well-being and cognitive functions . In the present experiment 40 healthy elderly men and women ( mean age , 69 yr ) participated in a double blind , placebo-controlled DHEA substitution study . For 2 weeks subjects took 50 mg DHEA daily , followed by a 2-week wash-out period and a 2-week placebo period . The treatment sequence was r and omized in a cross-over design . After 2 weeks of DHEA or placebo , psychological and physical well-being as well as cognitive performance were assessed using several question naires and neuropsychological tests . All subjects had low DHEAS baseline levels . DHEA substitution lead to a 5-fold increase in DHEAS levels in women ( from 0.67 + /- 0.1 to 4.1 + /- 0.4 micrograms/mL ; P < 0.001 ) and men ( from 0.85 + /- 0.1 to 4.5 + /- 0.4 micrograms/mL ; P < 0.001 ) . DHEA , and rostenedione , and testosterone levels also increased significantly in both sexes ( all P < 0.001 ) . No significant changes were observed in insulin-like growth factor I or insulin-like growth factor-binding protein-3 levels . DHEA replacement had no strong beneficial effect on any of the measured psychological or cognitive parameters . Only women tended to report an increase in well-being ( P = 0.11 ) and mood ( P = 0.10 ) , as assessed with question naires . They also showed better performance in one of six cognitive tests ( picture memory ) after DHEA . However , after Bonferroni alpha adjustment , this difference was no longer significant . No such trend was observed in men ( P > 0.20 ) . Likewise , no beneficial effects of DHEA substitution could be observed in any of the other tests of the neuropsychological test battery in either sex ( all P > 0.20 ) . In conclusion , the present data do not support the idea of strong beneficial effects of a physiological DHEA substitution on well-being or cognitive performance in healthy elderly individuals BACKGROUND The observation that dehydroepi and rosterone ( DHEA ) concentrations decrease markedly with age has led to the hypothesis that declining DHEA concentrations may contribute to age-related changes in cognition . In the United States , DHEA is widely available as an over-the-counter supplement that individuals are using in an effort to ameliorate age-related cognitive and physical changes . OBJECTIVE To investigate the relationship between age-associated decreases in endogenous DHEA sulfate ( DHEA-S ) concentrations and declines in neuropsychological performance in a prospect i ve , longitudinal study . METHODS The subjects were 883 men from a community-dwelling volunteer sample in the Baltimore Longitudinal Study of Aging . The men were aged 22 to 91 years at the initial visit , and they were followed up for as long as 31 years ( mean , 11 . 55 years ) , with biennial re assessment s of multiple cognitive domains and contemporaneous measurement of serum DHEA-S concentrations . Outcome measures were the results of cognitive tests of verbal and visual memory , 2 tests of mental status , phonemic and semantic word fluency tests , and measures of visuomotor scanning and attention . Serum DHEA-S concentrations were determined by st and ard radioimmunoassay . RESULTS Neither the rates of decline in mean DHEA-S concentrations nor the mean DHEA-S concentrations within individuals were related to cognitive status or cognitive decline . A comparison between the highest and lowest DHEA-S quartiles revealed no cognitive differences , despite the fact that these groups differed in endogenous DHEA-S concentration by more than a factor of 4 for a mean duration of 12 years . CONCLUSION Our longitudinal results augment those of previous prospect i ve studies by suggesting that the decline in endogenous DHEA-S concentration is independent of cognitive status and cognitive decline in healthy aging men Dehydroepi and rosterone ( DHEA ) and its sulfate , DHEA-S , are plentiful adrenal steroid hormones that decrease with aging and may have significant neuropsychiatric effects . In this study , six middle-aged and elderly patients with major depression and low basal plasma DHEA f1p4or DHEA-S levels were openly administered DHEA ( 30 - 90 mg/d x 4 weeks ) in doses sufficient to achieve circulating plasma levels observed in younger healthy individuals . Depression ratings , as well as aspects of memory performance significantly improved . One treatment-resistant patient received extended treatment with DHEA for 6 months : her depression ratings improved 48 - 72 % and her semantic memory performance improved 63 % . These measures returned to baseline after treatment ended . In both studies , improvements in depression ratings and memory performance were directly related to increases in plasma levels of DHEA and DHEA-S and to increases in their ratios with plasma cortisol levels . These preliminary data suggest DHEA may have antidepressant and promemory effects and should encourage double-blind trials in depressed patients There are few reported data on biochemical and functional correlates of and rogen levels in African-American men . This study aim ed at reporting physical and biochemical correlates of serum total testosterone ( total T ) , bioavailable testosterone ( BT ) and dehydroepi and rosterone-sulphate ( DHEAS ) levels in community-dwelling , African-American men aged 50 - 65 years . Home-based physical examinations and health status question naires were administered to r and omly sample d men . Body composition ( dual-energy X-ray absorptiometry ) , lower limb and h and -grip muscle strength , and neuropsychological functions were assessed . Levels of serum total T , BT , DHEAS , oestradiol ( E2 ) , adiponectin , leptin , triglycerides and glucose were measured . Multiple linear regression models were constructed to identify factors independently associated with and rogen levels . DHEAS levels declined from age 50 to 65 years ( p < 0.0001 ) , but total T and BT levels remained constant . Independent of other associated factors , higher total T levels were associated with lower serum triglyceride levels ( beta = -0.142 , p = 0.049 ) ; higher BT was associated with better performance on the trail-making tests ( TMT-B : TMT-A ratio : beta = -0.118 , p = 0.024 ) and higher DHEAS levels were associated with lower adiponectin ( beta = -0.293 ,
Output:
| Other positive correlations between DHEA-S and working memory , attention and verbal fluency were found only in women .
The DHEA effect on cognition is limited to one study conducted among young men with high-doses |
MS212183 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Study Design . A r and omized controlled trial . Objectives . To evaluate the efficacy of infliximab , a monoclonal antibody against tumor necrosis factor (TNF)-&agr ; in a r and omized controlled setting . Summary of Background Data . Recently , we obtained encouraging results in an open-label study of infliximab in patients with disc herniation-induced sciatica . Furthermore , the results of experimental studies support the use of infliximab in sciatica . Therefore , we initiated a r and omized , controlled trial ( FIRST II , Finnish Infliximab Related STudy ) to confirm the efficacy of a single infusion of infliximab for sciatic pain . Methods . Inclusion criteria were unilateral moderate to severe sciatic pain with an MRI-confirmed disc herniation concordant with the symptoms and signs of radicular pain . Patients had to be c and i date s for discectomy , as evaluated by an independent orthopedic surgeon . Forty patients were allocated to a single intravenous infusion of either infliximab 5 mg/kg or placebo . Assessment s at baseline and various time points included clinical examination with measurement of straight leg raising restriction ; question naires related to subjective symptoms ( leg and back pain by 100-mm visual analog scale , Oswestry disability ) ; sick leaves ; number of discectomies ; and adverse effects possibly related to treatment . The primary endpoint was a reduction in leg pain from baseline to 12 weeks , which was analyzed using a Mann-Whitney U test and repeated- measures analysis . Results . A significant reduction in leg pain was observed in both groups , with no significant difference between treatment regimens . Similar efficacy was observed between treatment groups for secondary endpoints . Seven patients in each group required surgery . No adverse effects related to treatment were encountered . Conclusions . The results of this r and omized trial do not support the use of infliximab for lumbar radicular pain in patients with disc herniation-induced sciatica Study Design . An open-label trial . Objectives . To test the long-term efficacy of infliximab , a monoclonal antibody against tumor necrosis factor-alpha ( TNF-α ) , in disc herniation-induced sciatica . Summary of Background Data . Our recent trial indicated that a single infusion of 3 mg/weight-kg of infliximab produced a rapid curative effect in disc herniation-induced sciatica . Here , we describe the 1-year effect of a 3 mg/kg of infliximab in these 10 patients and our experience with a lower dose of 1 mg/kg of infliximab for the same indication in 2 additional patients . Methods . Patients with severe sciatica were treated with a single infusion of infliximab , 3 mg/weight-kg in 10 patients and 1 mg/kg in 2 patients , intravenously over 2 hours . The outcomes ( leg and back pain on a 100-mm visual scale , Oswestry disability , clinical signs ) were assessed at 1 week , 2 weeks , 1 month , 3 months , 6 months , and 1 year after the infusion . The outcomes with 3 mg/kg of infliximab were compared to 62 patients who received periradicular saline for sciatica in a previous trial . The resorption rate of disc herniations from baseline to 1 year was compared between infliximab and control groups . Results . The response to 1 mg/kg of infliximab for leg pain was good only in 1 of the 2 patients treated , whereas the response to 3 mg/kg of infliximab for leg pain was sustained in most patients over the 1-year follow-up . The 1-year response significantly favored 3 mg/kg of infliximab over periradicular saline in leg pain ( P = 0.005 ) and disability ( P = 0.003 ) . Neurologic abnormalities normalized more comprehensively in the infliximab group ( P = 0.001 ) . Reduction in disc herniation volume did not differ between the infliximab-treated patients and controls . Conclusions . The results showed that the beneficial effect of a single infusion of 3 mg/kg of infliximab for herniation-induced sciatica is sustained in most patients over a 1-year follow-up period . Furthermore , infliximab does not seem to interfere with the spontaneous resorption of disc herniations Policy decisions often require synthesis of evidence from multiple sources , and the source studies typically vary in rigour and in relevance to the target question . We present simple methods of allowing for differences in rigour ( or lack of internal bias ) and relevance ( or lack of external bias ) in evidence synthesis . The methods are developed in the context of reanalysing a UK National Institute for Clinical Excellence technology appraisal in antenatal care , which includes eight comparative studies . Many were historically controlled , only one was a r and omized trial and doses , population s and outcomes varied between studies and differed from the target UK setting . Using elicited opinion , we construct prior distributions to represent the biases in each study and perform a bias-adjusted meta- analysis . Adjustment had the effect of shifting the combined estimate away from the null by approximately 10 % , and the variance of the combined estimate was almost tripled . Our generic bias modelling approach allows decisions to be based on all available evidence , with less rigorous or less relevant studies downweighted by using computationally simple methods Study Design . Prospect i ve , double-blind , reference-controlled , investigator-initiated , single center . Objective . To evaluate the efficacy of Autologous Conditioned Serum ( ACS ; Orthokine ) for the treatment of lumbar radicular compression in comparison to triamcinolone . Summary of Background Data . Evidence from animal studies indicates that cytokines such as interleukin-1 play a decisive role in the pathophysiology of lumbar radiculopathy . ACS is enriched in the interleukin-1 receptor antagonist and other anti-inflammatory cytokines . Methods . Thirty-two patients were treated by epidural perineural injections with ACS ; 27 patients were treated with 5 mg triamcinolone and 25 patients with 10 mg triamcinolone . Treatment was applied once per week for 3 consecutive weeks and followed for 6 months . The Visual Analogue Scale ( VAS ) of low back pain was the primary outcome measure . The Oswestry Disability Index ( ODI ) was the secondary endpoint of the study . All statistical analyses were performed in an exploratory manner using SAS for Windows , version 8.2 , on a personal computer . Descriptive statistics were calculated for the VAS and ODI by treatment group and time point . The data were su bmi tted to a repeated- measurements analysis of variance with effects on treatment group , time , and treatment group-by-time interaction . Results . Patients with lumbar back pain who were treated with ACS or the 2 triamcinolone concentrations showed a clinical ly remarkable and statistically significant reduction in pain and disability , as measured by patient administered outcome measurements . From Week 12 to the final evaluation at Week 22 , injections with ACS showed a consistent pattern of superiority over both triamcinolone groups with regard to the VAS score for pain , but statistical significance was observed only at Week 22 in direct comparison to the triamcinolone 5 group . However , there was no statistically significant difference between the 2 triamcinolone dosages during the 6 months of the study . Conclusion . ACS is an encouraging treatment option for patients with unilateral lumbar radicular compression . The decrease in pain was pronounced , clinical ly remarkable , and potentially superior to steroid injection Background : Recent evidence implicates the inflammatory cytokine tumor necrosis factor as a major cause of radiculopathy . Yet , whereas open-label studies with systemically delivered tumor necrosis factor inhibitors have yielded positive results , a placebo-controlled study failed to demonstrate efficacy . One variable that may have contributed to poor outcomes is low drug levels at the site of nerve inflammation . To date , no studies have evaluated the efficacy or safety of epidurally administered anti-tumor necrosis factor agents . Methods : A double-blind , placebo-controlled , dose-response study was conducted to evaluate an epidural tumor necrosis factor inhibitor . Twenty-four patients with subacute lumbosacral radiculopathy were r and omly assigned to receive two transforaminal epidural injections of 2 , 4 , or 6 mg of entanercept 2 weeks apart in successive groups of eight . In each group , two patients received epidural saline . A parallel epidural canine safety study was conducted using the same injection doses and paradigm as in the clinical study . Results : The animal and human safety studies revealed no behavioral , neurologic , or histologic evidence of drug-related toxicity . In the clinical arm , significant improvements in leg and back pain were collectively noted for the etanercept-treated patients , but not for the saline group , one month after treatment . One patient in the saline group ( 17 % ) , six patients in the 2-mg group ( 100 % ) , and four patients each in the 4-mg and 6-mg groups ( 67 % ) reported at least 50 % reduction in leg pain and a positive global perceived effect one month after treatment . Six months after treatment , the beneficial effects persisted in all but one patient . Conclusion : Epidural entanercept holds promise as a treatment for lumbosacral radiculopathy This article introduces the approach of GRADE to rating quality of evidence . GRADE specifies four categories-high , moderate , low , and very low-that are applied to a body of evidence , not to individual studies . In the context of a systematic review , quality reflects our confidence that the estimates of the effect are correct . In the context of recommendations , quality reflects our confidence that the effect estimates are adequate to support a particular recommendation . R and omized trials begin as high- quality evidence , observational studies as low quality . " Quality " as used in GRADE means more than risk of bias and so may also be compromised by imprecision , inconsistency , indirectness of study results , and publication bias . In addition , several factors can increase our confidence in an estimate of effect . GRADE provides a systematic approach for considering and reporting each of these factors . GRADE separates the process of assessing quality of evidence from the process of making recommendations . Judgments about the strength of a recommendation depend on more than just the quality of evidence OBJECTIVES To explore the efficacy of a tumour necrosis factor alpha ( TNFalpha ) inhibitor ( etanercept , Enbrel ) in patients with severe sciatica . METHODS A pilot study of etanercept was conducted in patients admitted to hospital for acute severe sciatica . Ten consecutive patients received three subcutaneous injections of etanercept ( 25 mg every 3 days ) in addition to st and ard analgesia . Response was evaluated at day 10 ( T1 ) and week 6 ( T2 ) using a visual analogue scale for leg pain ( VASL ) and for low back pain ( VASB ) , and two vali date d functional scores : the Oswestry disability index ( ODI ) and the Rol and Morris disability question naire ( RMDQ ) . The control group consisted of 10 patients with severe sciatica , who took part in an observational study on i.v . methylprednisolone . RESULTS In the etanercept group all variables improved : VASB from 36 to 7 ; VASL from 74 to 12 ; RMDQ from 17.8 to 5.8 , and ODI from 75.4 to 17.3 ; all p<0.001 . Pain ( VASL and VASB : p<0.001 ) and ODI ( p<0.05 ) were significantly better in the etanercept group than in the methylprednisolone group . CONCLUSION In this open , historical group controlled study , patients with severe sciatica had sustained improvement after a short treatment with etanercept that was better than st and ard care plus a short course of methylprednisolone . These results suggest that inhibition of TNFalpha is beneficial in the treatment of sciatica and support a pathological role for TNFalpha in the pathogenesis of sciatica . These results need to be confirmed by a r and omised controlled trial To study the natural history of acute sciatica , 208 patients with obvious symptoms and signs of a lumbar radiculopathy ( L5 and S1 ) were examined within 14 days of onset . A concomitant double-blind investigation of the effect of the nonsteroidal anti-inflammatory drug piroxicam was performed . The results measured by visual analog scale and Rol and 's functional tests showed a satisfactory improvement throughout the 4 weeks of observation . The piroxicam-treated group had same results as the control group . Based on question naires at months 3 and 12 approximately 30 % of the patients still complained about back trouble and 19.5 % were out of work after 1 year . Four patients underwent surgery during this period OBJECTIVE Sciatica is thought to have a good clinical outcome , but in fact , its natural history is not well known . STUDY DESIGN AND SETTING We studied a prospect i ve cohort of 3,164 workers from the French national electricity and gas company . In this cohort , 622 subjects suffered from sciatica in 1991 . The predictive factors of the persistence or recurrence of sciatica after 2 years were identified by multivariate analysis ( logistic regression ) . RESULTS Of the 622 subjects with sciatica in 1991 , 55 % still reported its symptoms in 1993 and 53 % in 1995 . Of those who had recovered from sciatica in 1993 , 61 % still had low back pain and 27 % of them long-lasting low back pain in 1993 . The factors predictive of the persistence or recurrence of sciatica in 1993 , identified by multivariate analysis , were : driving at least 2 hr/day , carrying heavy loads at work , a high level of psychosomatic problems , and sciatica symptoms the year before study inclusion . CONCLUSION Recovery from sciatica is less frequent than expected
Output:
| There was heterogeneity in the leg pain intensity and ODI results and improvements were no longer statistically significant when studies were restricted to RCTs .
There was a reduction in the need for discectomy , which was not statistically significant , and no difference in the number of adverse effects . |
MS212184 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
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Input: BACKGROUND Hepatitis C viral ( HCV ) infection is the leading cause of death due to liver disease in the United States . Currently , pegylated interferon and ribavirin produce sustained viral remission in only 50 % of patients . Additional agents are needed to increase the cure rate . In vitro experiments show strong antiviral effects of fluvastatin against HCV . OBJECTIVES : To assess the safety and antiviral effects of fluvastatin in chronic HCV carriers . METHODS : 31 veterans with chronic HCV were prospect ively given oral doses of fluvastatin , 20 to 320 mg/day , for 2–12 weeks with weekly monitoring of HCV RNA and liver tests . Reductions of viral load ( P < 0.01 ) versus a control group were considered suppressive . RESULTS : With 80 mg a day or less , 11/22 ( 50 % ) patients responded by lowering HCV RNA . The first lowering occurred within 4 weeks ( 9/11 , 82 % ) . The greatest weekly change in HCV RNA level was a 1.75 log10 reduction . When lowered in responders , the viral load remained relatively constant for 2–5 weeks ( 7/9 , 78 % ) , or on the next test rebounded immediately to a non-significant change from , baseline ( n = 2 ) . Continued lowering of virus was seen in 2/19 ( 22 % ) patients when the study ended . We found no evidence of liver tests worsening . CONCLUSIONS : FLV used as monotherapy in vivo showed suppressive effects of HCV clinical ly that are modest , variable , and often short-lived . These findings support “ proof-of-concept ” for pilot trials combining fluvastatin with st and ard therapy . Statins and fluvastatin , in particular , appear to be safe for use in hepatitis BACKGROUND & AIMS Simvastatin improves liver generation of nitric oxide and hepatic endothelial dysfunction in patients with cirrhosis , so it could be an effective therapy for portal hypertension . This r and omized controlled trial evaluated the effects of continuous simvastatin administration on the hepatic venous pressure gradient ( HVPG ) and its safety in patients with cirrhosis and portal hypertension . METHODS Fifty-nine patients with cirrhosis and portal hypertension ( HVPG > or = 12 mm Hg ) were r and omized to groups that were given simvastatin 20 mg/day for 1 month ( increased to 40 mg/day at day 15 ) or placebo in a double-blind clinical trial . R and omization was stratified according to whether the patient was being treated with beta-adrenergic blockers . We studied splanchnic and systemic hemodynamics and variables of liver function and safety before and after 1 month of treatment . RESULTS Simvastatin significantly decreased HVPG ( -8.3 % ) without deleterious effects in systemic hemodynamics . HVPG decreases were observed in patients who were receiving beta-adrenergic blockers ( -11.0 % ; P = .033 ) and in those who were not ( -5.9 % ; P = .013 ) . Simvastatin improved hepatic , fractional , and intrinsic clearance of indocyanine green , showing an improvement in effective liver perfusion and function . No significant changes in HVPG and liver function were observed in patients receiving placebo . The number of patients with adverse events did not differ significantly between groups . No patient was withdrawn from the study based on adverse events . CONCLUSIONS Simvastatin decreased HVPG and improved liver perfusion in patients with cirrhosis . These effects were additive with those of beta-adrenergic blockers . The beneficial effects of simvastatin should be confirmed in long-term clinical trials for portal hypertension BACKGROUND Pleiotropic effects of statins decrease intrahepatic resistance and portal hypertension . AIM We evaluated the effects of simvastatin on hepatic venous pressure gradient ( HVPG ) and azygos vein blood flow in cirrhotic patients . METHODS A 3-month prospect i ve , r and omized , triple-blind trial with simvastatin ( 40 mg/day ) vs. placebo was conducted in patients with cirrhotic portal hypertension . HVPG and azygos blood flow , measured by colour Doppler endoscopic ultrasound , were assessed before and after treatment . The primary endpoint was a decrease in the HVPG of at least 20 % from baseline or to ≤12 mmHg after the treatment . RESULTS 34 patients were prospect ively enrolled , and 24 completed the protocol . In the simvastatin group 6/11 patients ( 55 % ) presented a clinical ly relevant decrease in the HVPG ; no decrease was observed in the placebo group ( p=0.036 ) . Patients with medium/large oesophageal varices and previous variceal bleeding had a higher response rate to simvastatin . HVPG and azygos blood flow values were not correlated . No significant adverse events occurred . CONCLUSION Simvastatin lowers portal pressure and may even improve liver function . The haemodynamic effect appears to be more evident in patients with severe portal hypertension
Output:
| In summary , statin use is associated with a decreased incidence rate of cirrhosis and is most pronounced in Eastern countries but also in Western countries |
MS212185 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: We performed a 3-month , double-blind , placebo-controlled trial of 300 mg of gangliosides ( Cronassial ) in 40 out patients with amyotrophic lateral sclerosis ( ALS ) . We evaluated drug effect through physical examinations and symptom scales . Though this dosage had no major toxic effect , Cronassial treatment did not significantly benefit ALS patients Two double-blinded , placebo-controlled clinical trials of riluzole have now been carried out in more than 1,100 patients with ALS . The results of both studies show a modest benefit in prolonging survival that is statistically significant . These results led to the availability of this drug by the Food and Drug Administration for use in the United States beginning in early 1996 . This is the first drug that has been available for ALS . It begins a new era in both basic and clinical research in an attempt to find a cure for this disease . NEUROLOGY 1996;47(Suppl 2 ) : BACKGROUND In an attempt to better underst and and define the progression of amyotrophic lateral sclerosis ( ALS ) , we developed a classification of 5 discrete health states that reflect patients ' activities of daily living . These health states were used to determine whether patients with ALS who are treated with riluzole differed from those treated with placebo . SETTING Clinics for patients with ALS . DESIGN Placebo-controlled trial of riluzole treatment in 959 patients with ALS . INTERVENTIONS Treatment with riluzole or placebo . MAIN DEPENDENT MEASURES : A Cox model was used to assess whether , from the initial r and omization to the end of an 18-month follow-up , there was a difference in the times of transition into subsequent health states between patients treated with riluzole and those treated with placebo . RESULTS Our analysis showed a significant difference in the time to transit between the riluzole and the placebo groups in less severely affected cases , ie , state 2 and state A ( the milder states ) of ALS . CONCLUSION Patients receiving riluzole remained in the milder health states longer ( P<.05 ) A population of 31 patients with sporadic amyotrophic lateral sclerosis ( ALS ) was selected for a prospect i ve open study based on treatment with riluzole . A neurophysiological evaluation was performed by means of single and paired transcranial magnetic stimulation ( TMS ) . The examined parameters , excitability threshold , motor evoked potential ( MEP ) duration , silent period ( SP ) duration and time course of intracortical inhibition to paired TMS after 6 months treatment , were matched against those recorded from the patients themselves before the beginning of treatment and from 20 ( single TMS ) or 10 ( paired TMS ) age-matched control subjects . Normal behaviour of the SP in response to increasing TMS was found in the treated patients ; they showed a significant linear correlation between these two parameters ( r=0.96 ) comparable to that calculated for controls ( r=0.98 ) , and significantly different with respect to drug-free patients ( r=0.8 , P=0.014 ) . A significant reduced size of the ' conditioned ' MEPs to paired stimulation was documented in the treated patients compared with the untreated patients ( P=0.002 ) . Our neurophysiological contribution to the assessment of the effect of riluzole on the motor cortical inhibitory property in ALS may be considered a setting for controlled trials in extended patient series , even in a pre- clinical phase RILUZOLE , a glutamate antagonist , has been shown to be efficacious in the treatment of patients with amyotrophic lateral sclerosis ( ALS ) , allowing prolonged survival and time to tracheostomy . The efficacy of riluzole in thought to result from reduced glutamate excitotoxicity on motor neurons of patients with ALS , but this has never been demonstrated directly in vivo . N-acetylaspartate ( NAA ) , a compound that is readily measured in vivo using proton magnetic resonance spectroscopy , can be used as a surrogate marker for neuronal loss or sublethal injury . To determine whether riluzole reverses sublethal corticomotoneuron damage in patients with ALS we measured NAA/creatine ( Cr ) relative intensity ratios in the motor cortex before and after treatment with riluzole 50 mg bid . After 3 weeks of riluzole therapy in 11 patients NAA/Cr increased from 2.14 ± 0.26 to 2.27 ± 0.24 ( p = 0.044 ) , whereas , in 12 untreated patients NAA/Cr decreased from 2.17 ± 0.20 to 2.08 ± 0.20 ( p = 0.099 ) . Thus the change in NAA/Cr between the treated and untreated groups was 0.22 ± 0.095 ( p = 0.008 ) . The magnitude of increase in NAA/Cr in those treated was not correlated with age , sex , duration of treatment or disease , the presence of probable or definite upper motor neuron ( UMN ) signs , bulbar features , or pre-treatment NAA/Cr . We conclude that magnetic resonance spectroscopy can provide a novel surrogate measure of neuronal integrity that demonstrates reversal of sublethal UMN injury in patients with ALS within weeks of initiating riluzole therapy
Output:
| There was a small beneficial effect on both bulbar and limb function , but not on muscle strength .
REVIEW ER 'S CONCLUSIONS Riluzole 100 mg daily is reasonably safe and probably prolongs survival by about two months in patients with amyotrophic lateral sclerosis . |
MS212186 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: BACKGROUND Lung cancer screening might be a teachable moment for smoking cessation intervention . The objective was to investigate whether a tailored self-help smoking cessation intervention is more effective in inducing smoking cessation compared to a st and ard brochure in male smokers who participate in the Dutch-Belgian r and omised controlled lung cancer screening trial ( NELSON trial ) . METHODS Two r and om sample s of male smokers who had received either a st and ard brochure ( n=642 ) or a tailoring question naire for computer-tailored smoking cessation information ( n=642 ) were sent a question naire to measure smoking behaviour two years after r and omisation . RESULTS Twenty-three percent of the male smokers in the tailored information group returned a completed tailoring question naire and thus received the tailored advice . The prolonged smoking abstinence was slightly , but not statistically significant , lower amongst those r and omised in the tailored information group ( 12.5 % ) compared with the brochure group ( 15.6 % ) ( OR=0.77 ( 95%-CI : 0.56 - 1.06 ) . The level of education and intention to quit smoking significantly predicted smoking cessation at follow-up ( p<0.05 ) . The majority of the respondents did not recall whether and which smoking cessation intervention they had received at r and omisation after 2-years of follow-up . CONCLUSION The current study showed no advantage of tailored smoking cessation information over st and ard self-help information amongst male smokers with a long term smoking history who participate in a lung cancer screening trial after two years of follow-up . However , the low percentage participants who actually received the tailored advice limited the ability to find an advantage BACKGROUND Low-dose CT screening is recommended for individuals at high risk of developing lung cancer . However , CT screening does not detect all lung cancers : some might be missed at screening , and others can develop in the interval between screens . The NELSON trial is a r and omised trial to assess the effect of screening with increasing screening intervals on lung cancer mortality . In this prespecified analysis , we aim ed to assess screening test performance , and the epidemiological , radiological , and clinical characteristics of interval cancers in NELSON trial participants assigned to the screening group . METHODS Eligible participants in the NELSON trial were those aged 50 - 75 years , who had smoked 15 or more cigarettes per day for more than 25 years or ten or more cigarettes for more than 30 years , and were still smoking or had quit less than 10 years ago . We included all participants assigned to the screening group who had attended at least one round of screening . Screening test results were based on volumetry using a two-step approach . Initially , screening test results were classified as negative , indeterminate , or positive based on nodule presence and volume . Subsequently , participants with an initial indeterminate result underwent follow-up screening to classify their final screening test result as negative or positive , based on nodule volume doubling time . We obtained information about all lung cancer diagnoses made during the first three rounds of screening , plus an additional 2 years of follow-up from the national cancer registry . We determined epidemiological , radiological , participant , and tumour characteristics by reassessing medical files , screening CTs , and clinical CTs . The NELSON trial is registered at www.trialregister.nl , number IS RCT N63545820 . FINDINGS 15,822 participants were enrolled in the NELSON trial , of whom 7915 were assigned to low-dose CT screening with increasing interval between screens , and 7907 to no screening . We included 7155 participants in our study , with median follow-up of 8·16 years ( IQR 7·56 - 8·56 ) . 187 ( 3 % ) of 7155 screened participants were diagnosed with 196 screen-detected lung cancers , and another 34 ( < 1 % ; 19 [ 56 % ] in the first year after screening , and 15 [ 44 % ] in the second year after screening ) were diagnosed with 35 interval cancers . For the three screening rounds combined , with a 2-year follow-up , sensitivity was 84·6 % ( 95 % CI 79·6 - 89·2 ) , specificity was 98·6 % ( 95 % CI 98·5 - 98·8 ) , positive predictive value was 40·4 % ( 95 % CI 35·9 - 44·7 ) , and negative predictive value was 99·8 % ( 95 % CI 99·8 - 99·9 ) . Retrospective assessment of the last screening CT and clinical CT in 34 patients with interval cancer showed that interval cancers were not visible in 12 ( 35 % ) cases . In the remaining cases , cancers were visible when retrospectively assessed , but were not diagnosed because of radiological detection and interpretation errors ( 17 [ 50 % ] ) , misclassification by the protocol ( two [ 6 % ] ) , participant non-compliance ( two [ 6 % ] ) , and non-adherence to protocol ( one [ 3 % ] ) . Compared with screen-detected cancers , interval cancers were diagnosed at more advanced stages ( 29 [ 83 % ] of 35 interval cancers vs 44 [ 22 % ] of 196 screen-detected cancers diagnosed in stage III or IV ; p<0·0001 ) , were more often small-cell carcinomas ( seven [ 20 % ] vs eight [ 4 % ] ; p=0·003 ) and less often adenocarcinomas ( nine [ 26 % ] vs 102 [ 52 % ] ; p=0·005 ) . INTERPRETATION Lung cancer screening in the NELSON trial yielded high specificity and sensitivity , with only a small number of interval cancers . The results of this study could be used to improve screening algorithms , and reduce the number of missed cancers . FUNDING Zorgonderzoek Nederl and Medische Wetenschappen and Koningin Wilhelmina Fonds The National Lung Screening Trial ( NLST ) has sparked new interest in the adoption of lung cancer screening using low-dose computed tomography ( LDCT ) . If adopted at a national level , LDCT screening may prevent approximately 18,000 lung cancer deaths per year , potentially constituting a high-value public health intervention . Before incorporating LDCT screening into practice , health care institutions need to consider the risks associated with LDCT screening and the impact of LDCT screening on health care costs , as well as other remaining areas of uncertainty , including the unknown cost-effectiveness of LDCT screening . This article will review the benefits and risks of LDCT screening in light of the results of the NLST and other r and omized trials , it will discuss the additional health care costs associated with LDCT screening from the perspective of health care payers , and it will examine the published cost-effectiveness analyses of LDCT screening . A subsequent discussion highlights guideline recommendations for implementation strategies , the goals of which are to ensure that those eligible for LDCT screening derive the benefits while minimizing the risks of screening and avoiding an unnecessary escalation in screening-related costs . The article concludes by endorsing the use of LDCT screening in institutions capable of responsible implementation of screening in both medical and economic terms . The key elements of responsible implementation include the development of st and ardized screening practice s , careful selection of screening c and i date s , and the creation of prospect i ve registries that will mitigate current areas of uncertainty regarding LDCT screening BACKGROUND Reliable risk prediction tools for estimating individual probability of lung cancer have important public health implication s. We constructed and vali date d a comprehensive clinical tool for lung cancer risk prediction by smoking status . METHODS Epidemiologic data from 1851 lung cancer patients and 2001 matched control subjects were r and omly divided into separate training ( 75 % of the data ) and validation ( 25 % of the data ) sets for never , former , and current smokers , and multivariable models were constructed from the training sets . The discriminatory ability of the models was assessed in the validation sets by examining the areas under the receiver operating characteristic curves and with concordance statistics . Absolute 1-year risks of lung cancer were computed using national incidence and mortality data . An ordinal risk index was constructed for each smoking status category by summing the odds ratios from the multivariable regression analyses for each risk factor . RESULTS All variables that had a statistically significant association with lung cancer ( environmental tobacco smoke , family history of cancer , dust exposure , prior respiratory disease , and smoking history variables ) have strong biologically plausible etiologic roles in the disease . The concordance statistics in the validation sets for the never , former , and current smoker models were 0.57 , 0.63 , and 0.58 , respectively . The computed 1-year absolute risk of lung cancer for a hypothetical male current smoker with an estimated relative risk close to 9 was 8.68 % . The ordinal risk index performed well in that true-positive rates in the design ated high-risk categories were 69 % and 70 % for current and former smokers , respectively . CONCLUSIONS If confirmed in other studies , this risk assessment procedure could use easily obtained clinical information to identify individuals who may benefit from increased screening surveillance for lung cancer . Although the concordance statistics were modest , they are consistent with those from other risk prediction models Objective To evaluate the impact of telling patients their estimated spirometric lung age as an incentive to quit smoking . Design R and omised controlled trial . Setting Five general practice s in Hertfordshire , Engl and . Participants 561 current smokers aged over 35 . Intervention All participants were offered spirometric assessment of lung function . Participants in intervention group received their results in terms of “ lung age ” ( the age of the average healthy individual who would perform similar to them on spirometry ) . Those in the control group received a raw figure for forced expiratory volume at one second ( FEV1 ) . Both groups were advised to quit and offered referral to local NHS smoking cessation services . Main outcome measures The primary outcome measure was verified cessation of smoking by salivary cotinine testing 12 months after recruitment . Secondary outcomes were reported changes in daily consumption of cigarettes and identification of new diagnoses of chronic obstructive lung disease . Results Follow-up was 89 % . Independently verified quit rates at 12 months in the intervention and control groups , respectively , were 13.6 % and 6.4 % ( difference 7.2 % , P=0.005 , 95 % confidence interval 2.2 % to 12.1 % ; number needed to treat 14 ) . People with worse spirometric lung age were no more likely to have quit than those with normal lung age in either group . Cost per successful quitter was estimated at £ 280 ( € 366 , $ 556 ) . A new diagnosis of obstructive lung disease was made in 17 % in the intervention group and 14 % in the control group ; a total of 16 % ( 89/561 ) of participants . Conclusion Telling smokers their lung age significantly improves the likelihood of them quitting smoking , but the mechanism by which this intervention achieves its effect is unclear . Trial registration National Research Register N0096173751 BACKGROUND Although there is no proven benefit associated with screening for lung cancer , screening programs are attracting many individuals who perceive themselves to be at high risk due to smoking . We sought to determine whether the risk of lung cancer varies predictably among smokers . METHODS We used data on 18 172 subjects enrolled in the Carotene and Retinol Efficacy Trial (CARET)-a large , r and omized trial of lung cancer prevention-to derive a lung cancer risk prediction model . Model inputs included the subject 's age , sex , asbestos exposure history , and smoking history . We assessed the model 's calibration by comparing predicted and observed rates of lung cancer across risk deciles and vali date d it by assessing the extent to which a model estimated on data from five CARET study sites could predict events in the sixth study site . We then applied the model to evaluate the risk of lung cancer among smokers enrolled in a study of lung cancer screening with computed tomography ( CT ) . RESULTS The model was internally valid and well calibrated . Ten-year lung cancer risk varied greatly among participants in the CT study , from 15 % for a 68-year-old man who has smoked two packs per day for 50 years and continues to smoke , to 0.8 % for a 51-year-old woman who smoked one pack per day for 28 years before quitting 9 years earlier . Even among the subset of CT study participants who would be eligible for a clinical trial of cancer prevention , risk varied greatly . CONCLUSIONS The risk of lung cancer varies widely among smokers . Accurate risk prediction may help individuals who are contemplating voluntary screening to balance the potential benefits and risks . Risk prediction may also be useful for research ers design ing clinical trials of lung cancer prevention STUDY OBJECTIVES To develop and vali date a model for estimating the risk of lung cancer death in current and former smokers . The model is intended for use in analyzing a population of subjects who are undergoing lung cancer screening or receiving lung cancer chemoprevention , to determine whether the intervention has altered lung cancer mortality . DESIGN / SETTING / PATIENTS Model derivation was based on analyses of the placebo arm of the Carotene and Retinol Efficacy Trial . Model validation was based on analyses of three other longitudinal cohorts . MEASUREMENTS Observed and predicted number of deaths due to lung cancer . RESULTS In internal validation , the model was highly concordant and well calibrated . In external validation , the model predictions were similar to what was observed in all of the validation analyses . The predicted and observed deaths within 6 years were very similar when ass
Output:
| CONCLUSIONS Following the strategies delineated in this policy statement may help sites to develop comprehensive LDCT screening programs that are safe and effective |
MS212187 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: Background Anti-angiogenic treatment is believed to have at least cystostatic effects in highly vascularized tumours like pancreatic cancer . In this study , the treatment effects of the angiogenesis inhibitor Cilengitide and gemcitabine were compared with gemcitabine alone in patients with advanced unresectable pancreatic cancer . Methods A multi-national , open-label , controlled , r and omized , parallel-group , phase II pilot study was conducted in 20 centers in 7 countries . Cilengitide was administered at 600 mg/m2 twice weekly for 4 weeks per cycle and gemcitabine at 1000 mg/m2 for 3 weeks followed by a week of rest per cycle . The planned treatment period was 6 four-week cycles . The primary endpoint of the study was overall survival and the secondary endpoints were progression-free survival ( PFS ) , response rate , quality of life ( QoL ) , effects on biological markers of disease ( CA 19.9 ) and angiogenesis ( vascular endothelial growth factor and basic fibroblast growth factor ) , and safety . An ancillary study investigated the pharmacokinetics of both drugs in a subset of patients . Results Eighty-nine patients were r and omized . The median overall survival was 6.7 months for Cilengitide and gemcitabine and 7.7 months for gemcitabine alone . The median PFS times were 3.6 months and 3.8 months , respectively . The overall response rates were 17 % and 14 % , and the tumor growth control rates were 54 % and 56 % , respectively . Changes in the levels of CA 19.9 went in line with the clinical course of the disease , but no apparent relationships were seen with the biological markers of angiogenesis . QoL and safety evaluations were comparable between treatment groups . Pharmacokinetic studies showed no influence of gemcitabine on the pharmacokinetic parameters of Cilengitide and vice versa . Conclusion There were no clinical ly important differences observed regarding efficacy , safety and QoL between the groups . The observations lay in the range of other clinical studies in this setting . The combination regimen was well tolerated with no adverse effects on the safety , tolerability and pharmacokinetics of either agent PURPOSE To define the safety , efficacy , and pharmacogenetic and pharmacodynamic effects of sorafenib with gemcitabine-based chemoradiotherapy ( CRT ) in locally advanced pancreatic cancer . METHODS AND MATERIAL S Patients received gemcitabine 1000 mg/m(2 ) intravenously weekly × 3 every 4 weeks per cycle for 1 cycle before CRT and continued for up to 4 cycles after CRT . Weekly gemcitabine 600 mg/m(2 ) intravenously was given during concurrent intensity modulated radiation therapy of 50 Gy to gross tumor volume in 25 fractions . Sorafenib was dosed orally 400 mg twice daily until progression , except during CRT when it was escalated from 200 mg to 400 mg daily , and 400 mg twice daily . The maximum tolerated dose cohort was exp and ed to 15 patients . Correlative studies included dynamic contrast-enhanced MRI and angiogenesis genes polymorphisms ( VEGF-A and VEGF-R2 single nucleotide polymorphisms ) . RESULTS Twenty-seven patients were enrolled . No dose-limiting toxicity occurred during induction gemcitabine/sorafenib followed by concurrent CRT . The most common grade 3/4 toxicities were fatigue , hematologic , and gastrointestinal . The maximum tolerated dose was sorafenib 400 mg twice daily . The median progression-free survival and overall survival for 25 evaluable patients were 10.6 and 12.6 months , respectively . The median overall survival for patients with VEGF-A -2578 AA , -1498 CC , and -1154 AA versus alternate genotypes was 21.6 versus 14.7 months . Dynamic contrast-enhanced MRI demonstrated higher baseline K(trans ) in responding patients . CONCLUSIONS Concurrent sorafenib with CRT had modest clinical activity with increased gastrointestinal toxicity in localized unresectable pancreatic cancer . Select VEGF-A/VEGF-R2 genotypes were associated with favorable survival Gemcitabine is a key drug for the treatment of pancreatic cancer ; however , with its limitation in clinical benefits , the development of another potent therapeutic is necessary . Vascular endothelial growth factor receptor 2 is an essential target for tumor angiogenesis , and we have conducted a phase I clinical trial using gemcitabine and vascular endothelial growth factor receptor 2 peptide ( elpamotide ) . Based on the promising results of this phase I trial , a multicenter , r and omized , placebo‐controlled , double‐blind phase II/III clinical trial has been carried out for pancreatic cancer . The eligibility criteria included locally advanced or metastatic pancreatic cancer . Patients were assigned to either the Active group ( elpamotide + gemcitabine ) or Placebo group ( placebo + gemcitabine ) in a 2:1 ratio by the dynamic allocation method . The primary endpoint was overall survival . The Harrington – Fleming test was applied to the statistical analysis in this study to evaluate the time‐lagged effect of immunotherapy appropriately . A total of 153 patients ( Active group , n = 100 ; Placebo group , n = 53 ) were included in the analysis . No statistically significant differences were found between the two groups in the prolongation of overall survival ( Harrington – Fleming P‐value , 0.918 ; log – rank P‐value , 0.897 ; hazard ratio , 0.87 , 95 % confidence interval [ CI ] , 0.486–1.557 ) . Median survival time was 8.36 months ( 95 % CI , 7.46–10.18 ) for the Active group and 8.54 months ( 95 % CI , 7.33–10.84 ) for the Placebo group . The toxicity observed in both groups was manageable . Combination therapy of elpamotide with gemcitabine was well tolerated . Despite the lack of benefit in overall survival , subgroup analysis suggested that the patients who experienced severe injection site reaction , such as ulceration and erosion , might have better survival Objectives In mouse models of pancreatic cancer , IPI-926 , an oral Hedgehog inhibitor , increases chemotherapy delivery by depleting tumor-associated stroma . This multicenter phase Ib study evaluated IPI-926 in combination with FOLFIRINOX ( 5-fluorouracil , leucovorin , irinotecan , oxaliplatin ) in patients with advanced pancreatic cancer . Methods Patients were treated with once-daily IPI-926 plus FOLFIRINOX . A 3 + 3 dose escalation design was used , with cohort expansion at the maximum tolerated dose . A subset of patients underwent perfusion computed tomography to assess changes in tumor perfusion . Results The maximum tolerated dose was identified 1 dose level below st and ard FOLFIRINOX . Common treatment-related adverse events included liver function test abnormalities , neuropathy , nausea/vomiting , and diarrhea . Objective response rate was high ( 67 % ) , and patients receiving IPI-926 maintenance showed further declines in CA19 - 9 levels even after FOLFIRINOX discontinuation . Treatment did not result in consistent increases in tumor perfusion . The study closed early when a separate phase II trial of IPI-926 plus gemcitabine indicated detrimental effects of this combination . Conclusions This is the first study to demonstrate the feasibility of using FOLFIRINOX as the chemotherapeutic backbone in a clinical trial design . Although robust antitumor activity and acceptable safety were observed with the addition of IPI-926 to this regimen , future development of Hedgehog inhibitors in pancreatic cancer seems unlikely BACKGROUND Nivolumab , a fully human IgG4 programmed death 1 ( PD-1 ) immune-checkpoint-inhibitor antibody , disrupts PD-1-mediated signaling and may restore antitumor immunity . METHODS In this r and omized , open-label , international phase 3 study , we assigned patients with nonsquamous non-small-cell lung cancer ( NSCLC ) that had progressed during or after platinum-based doublet chemotherapy to receive nivolumab at a dose of 3 mg per kilogram of body weight every 2 weeks or docetaxel at a dose of 75 mg per square meter of body-surface area every 3 weeks . The primary end point was overall survival . RESULTS Overall survival was longer with nivolumab than with docetaxel . The median overall survival was 12.2 months ( 95 % confidence interval [ CI ] , 9.7 to 15.0 ) among 292 patients in the nivolumab group and 9.4 months ( 95 % CI , 8.1 to 10.7 ) among 290 patients in the docetaxel group ( hazard ratio for death , 0.73 ; 96 % CI , 0.59 to 0.89 ; P=0.002 ) . At 1 year , the overall survival rate was 51 % ( 95 % CI , 45 to 56 ) with nivolumab versus 39 % ( 95 % CI , 33 to 45 ) with docetaxel . With additional follow-up , the overall survival rate at 18 months was 39 % ( 95 % CI , 34 to 45 ) with nivolumab versus 23 % ( 95 % CI , 19 to 28 ) with docetaxel . The response rate was 19 % with nivolumab versus 12 % with docetaxel ( P=0.02 ) . Although progression-free survival did not favor nivolumab over docetaxel ( median , 2.3 months and 4.2 months , respectively ) , the rate of progression-free survival at 1 year was higher with nivolumab than with docetaxel ( 19 % and 8 % , respectively ) . Nivolumab was associated with even greater efficacy than docetaxel across all end points in subgroups defined according to prespecified levels of tumor-membrane expression ( ≥1 % , ≥5 % , and ≥10 % ) of the PD-1 lig and . Treatment-related adverse events of grade 3 or 4 were reported in 10 % of the patients in the nivolumab group , as compared with 54 % of those in the docetaxel group . CONCLUSIONS Among patients with advanced nonsquamous NSCLC that had progressed during or after platinum-based chemotherapy , overall survival was longer with nivolumab than with docetaxel . ( Funded by Bristol-Myers Squibb ; CheckMate 057 Clinical Trials.gov number , NCT01673867 . ) Inoperable cancer of the exocrine pancreas responds poorly to most conventional anti-cancer agents , and new agents are required to palliate this disease . Seocalcitol ( EB1089 ) , a vitamin D analogue , can inhibit growth , induce differentiation and induce apoptosis of cancer cell lines in vitro and can also inhibit growth of pancreatic cancer xenografts in vivo . Thirty-six patients with advanced pancreatic cancer received once daily oral treatment with seocalcitol with dose escalation every 2 weeks until hypercalcaemia occurred , following which patients continued with maintenance therapy . The most frequent toxicity was the anticipated dose-dependent hypercalcaemia , with most patients tolerating a dose of 10–15 μg per day in chronic administration . Fourteen patients completed at least 8 weeks of treatment and were evaluable for efficacy , whereas 22 patients were withdrawn prior to completing 8 weeks ' treatment and in 20 of these patients withdrawal was due to clinical deterioration as a result of disease progression . No objective responses were observed , with five of 14 patients having stable disease in whom the duration of stable disease was 82–532 days ( median=168 days ) . The time to treatment failure ( n=36 ) ranged from 22 to 847 days , and with a median survival of approximately 100 days . Seocalcitol is well tolerated in pancreatic cancer but has no objective anti-tumour activity in advanced disease . Further studies are necessary to determine if this agent has any cytostatic activity in this malignancy in minimal disease states BACKGROUND Nivolumab ( a programmed death 1 [ PD-1 ] checkpoint inhibitor ) and ipilimumab ( a cytotoxic T-lymphocyte-associated antigen 4 [ CTLA-4 ] checkpoint inhibitor ) have been shown to have complementary activity in metastatic melanoma . In this r and omized , double-blind , phase 3 study , nivolumab alone or nivolumab plus ipilimumab was compared with ipilimumab alone in patients with metastatic melanoma . METHODS We assigned , in a 1:1:1 ratio , 945 previously untreated patients with unresectable stage III or IV melanoma to nivolumab alone , nivolumab plus ipilimumab , or ipilimumab alone . Progression-free survival and overall survival were co primary end points . Results regarding progression-free survival are presented here . RESULTS The median progression-free survival was 11.5 months ( 95 % confidence interval [ CI ] , 8.9 to 16.7 ) with nivolumab plus ipilimumab , as compared with 2.9 months
Output:
| The qualitative synthesis revealed a treatment advantage of combined therapy with nab-paclitaxel , while the meta- analysis on anti-VEGF/VEGFR drugs demonstrated marginal improvement of objective response rates and progression-free survival , but not overall survival . |
MS212188 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
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***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: Therapeutic interventions that incorporate training in mindfulness meditation have become increasingly popular , but to date little is known about neural mechanisms associated with these interventions . Mindfulness-Based Stress Reduction ( MBSR ) , one of the most widely used mindfulness training programs , has been reported to produce positive effects on psychological well-being and to ameliorate symptoms of a number of disorders . Here , we report a controlled longitudinal study to investigate pre-post changes in brain gray matter concentration attributable to participation in an MBSR program . Anatomical magnetic resonance ( MR ) images from 16 healthy , meditation-naïve participants were obtained before and after they underwent the 8-week program . Changes in gray matter concentration were investigated using voxel-based morphometry , and compared with a waiting list control group of 17 individuals . Analyses in a priori regions of interest confirmed increases in gray matter concentration within the left hippocampus . Whole brain analyses identified increases in the posterior cingulate cortex , the temporo-parietal junction , and the cerebellum in the MBSR group compared with the controls . The results suggest that participation in MBSR is associated with changes in gray matter concentration in brain regions involved in learning and memory processes , emotion regulation , self-referential processing , and perspective taking Introduction Internet-delivered psychological interventions among people with chronic pain have the potential to overcome environmental and economic barriers to the provision of evidence -based psychological treatment in the Irish health service context . While the use of internet-delivered cognitive – behavioural therapy programmes has been consistently shown to have small-to-moderate effects in the management of chronic pain , there is a paucity in the research regarding the effectiveness of an internet-delivered Acceptance and Commitment Therapy ( ACT ) programme among people with chronic pain . The current study will compare the clinical -effectiveness and cost-effectiveness of an online ACT intervention with a waitlist control condition in terms of the management of pain-related functional interference among people with chronic pain . Methods and analysis Participants with non-malignant pain that persists for at least 3 months will be r and omised to one of two study conditions . The experimental group will undergo an eight-session internet-delivered ACT programme over an 8-week period . The control group will be a waiting list group and will be offered the ACT intervention after the 3-month follow-up period . Participants will be assessed preintervention , postintervention and at a 3-month follow-up . The primary outcome will be pain-related functional interference . Secondary outcomes will include : pain intensity , depression , global impression of change , acceptance of chronic pain and quality of life . A qualitative evaluation of the perspectives of the participants regarding the ACT intervention will be completed after the trial . Ethics and dissemination The study will be performed in agreement with the Declaration of Helsinki and is approved by the National University of Irel and Galway Research Ethics Committee ( 12/05/05 ) . The results of the trial will be published according to the CONSORT statement and will be presented at conferences and reported in peer- review ed journals . Trial registration number IS RCT N18166896 Acceptance and Commitment Therapy ( ACT ) training often includes experiential elements aim ed at improving therapist psychological flexibility , yet the effects of ACT training on therapist psychological flexibility have yet to be evaluated . This pilot study examines the effects of experiential phone consultation as an adjunct to a st and ard continuing education workshop on psychological flexibility and burnout among therapists learning ACT . In this study , counselors taking a 2-day ACT workshop were r and omly assigned to either six 30-min phone consultation sessions ( n = 10 ) or no additional contact ( n = 10 ) . The results show that those in the consultation condition reported higher psychological flexibility at the 3-month follow-up compared to the workshop-only condition . Improvements in ACT knowledge , overall burnout , and personal accomplishment were found in both groups , independent of whether they received phone consultation , and this increase was maintained over time . In conclusion , ACT phone consultation contributed to counselor psychological flexibility above the workshop alone and appears to be feasible as a means to improve counselor psychological flexibility Fibromyalgia Syndrome ( FMS ) is a chronic pain condition characterized by pain , fatigue , and nonrestorative sleep . The disruptive symptoms of FMS are associated with reductions in quality of life related to family , intimate relationships , and work . The present study was part of a r and omized pilot study of an 8-week Acceptance and Commitment Therapy ( ACT ) intervention compared to education in a sample of 28 women with FMS . The Chronic Pain Values Inventory was administered at baseline , postintervention , and 12 week follow-up . Both groups showed significant improvements in family success , which were maintained at follow-up . Groups showed a differential pattern of success in work . The ACT group demonstrated significant , maintained improvements in success in intimate relationships , while the education group reported no changes over time . Findings suggest that both interventions may lead to improvements in valued living ; however different interventions may be best suited for certain valued domains . The results of this study indicate that FMS patients are able to improve their success in family and intimate relationships and losses in these areas are not necessarily permanent Abstract One way to improve treatment effects of chronic pain is to identify and improve control over mechanisms of therapeutic change . One treatment approach that includes a specific proposed mechanism is acceptance and commitment therapy ( ACT ) with its focus on increasing psychological flexibility ( PF ) . The aim of the present study was to examine the role of PF as a mechanism of change in ACT . This is based on mediation analyses of data from a previously reported r and omized controlled trial , evaluating the effectiveness of an ACT-based online intervention for chronic pain ( ACTonPain ) . We performed secondary analyses on pretreatment , posttreatment , and follow-up data from 302 adults , receiving a guided ( n = 100 ) or unguided ( n = 101 ) version of ACTonPain , or allocated to the waitlist control group ( n = 101 ) . Structural equation modelling and a bias-corrected bootstrap approach were applied to examine the indirect effects of the treatment through pretreatment and posttreatment changes in the latent construct reflecting PF . The latent construct consisted of data from the Chronic Pain Acceptance Question naire and the Acceptance and Action Question naire . The outcomes were pretreatment to follow-up changes in pain interference , anxiety , depression , pain , and mental and physical health . Structural equation modelling analyses revealed that changes in PF significantly mediated pretreatment to follow-up changes in all outcomes in the intervention groups compared with waitlist ( st and ardized estimates ranged from I0.16I to I0.69I ) . Global model fit yielded modest but acceptable results . Findings are consistent with the theoretical framework behind ACT and contribute to growing evidence , supporting a focus on PF to optimize treatment effects Abstract Although cognitive – behavioral therapies ( CBT ) have been demonstrated to be effective for a variety of chronic pain problems , patients vary in their response and little is known about patient characteristics that predict or moderate treatment effects . Furthermore , although cognitive – behavioral theory posits that changes in patient beliefs and coping mediate the effects of CBT on patient outcomes , little research has systematic ally tested this . Therefore , we examined mediators , moderators , and predictors of treatment effects in a r and omized controlled trial of CBT for chronic temporom and ibular disorder ( TMD ) pain . Pre‐ to post‐treatment changes in pain beliefs ( control over pain , disability , and pain signals harm ) , catastrophizing , and self‐efficacy for managing pain mediated the effects of CBT on pain , activity interference , and jaw use limitations at one year . In individual mediator analyses , change in perceived pain control was the mediator that explained the greatest proportion of the total treatment effect on each outcome . Analyzing the mediators as a group , self‐efficacy had unique mediating effects beyond those of control and the other mediators . Patients who reported more pain sites , depressive symptoms , non‐specific physical problems , rumination , catastrophizing , and stress before treatment had higher activity interference at one year . The effects of CBT generally did not vary according to patient baseline characteristics , suggesting that all patients potentially may be helped by this therapy . The results provide further support for cognitive – behavioral models of chronic pain and point to the potential benefits of interventions to modify specific pain‐related beliefs in CBT and in other health care encounters In this study , 67 participants ( 95 % female ) with fibromyalgia ( FM ) were r and omly assigned to an online acceptance and commitment therapy ( online ACT ) and treatment as usual ( TAU ; ACT + TAU ) protocol or a TAU control condition . Online ACT + TAU participants were asked to complete 7 modules over an 8-week period . Assessment s were completed at pre-treatment , post-treatment , and 3-month follow-up periods and included measures of FM impact ( primary outcome ) , depression , pain , sleep , 6-minute walk , sit to st and , pain acceptance ( primary process variable ) , mindfulness , cognitive fusion , valued living , kinesiophobia , and pain catastrophizing . The results indicated that online ACT + TAU participants significantly improved in FM impact , relative to TAU ( P < .001 ) , with large between condition effect sizes at post-treatment ( 1.26 ) and follow-up ( 1.59 ) . Increases in pain acceptance significantly mediated these improvements ( P = .005 ) . Significant improvements in favor of online ACT + TAU were also found on measures of depression ( P = .02 ) , pain ( P = .01 ) , and kinesiophobia ( P = .001 ) . Although preliminary , this study highlights the potential for online ACT to be an efficacious , accessible , and cost-effective treatment for people with FM and other chronic pain conditions . PERSPECTIVE Online ACT reduced FM impact relative to a TAU control condition in this r and omized controlled trial . Reductions in FM impact were mediated by improvements in pain acceptance . Online ACT appears to be a promising intervention for FM The aim of this study was to analyze the cost utility of a group-based form of acceptance and commitment therapy ( GACT ) in patients with fibromyalgia ( FM ) compared with patients receiving recommended pharmacological treatment ( RPT ) or on a waiting list ( WL ) . The data were derived from a previously published study , a r and omized controlled trial that focused on clinical outcomes . Health economic outcomes included health-related quality of life and health care use at baseline and at 6-month follow-up using the EuroQoL and the Client Service Receipt Inventory , respectively . Analyses included quality -adjusted life years , direct and indirect cost differences , and incremental cost effectiveness ratios . A total of 156 FM patients were r and omized ( 51 GACT , 52 RPT , 53 WL ) . GACT was related to significantly less direct costs over the 6-month study period compared with both control arms ( GACT € 824.2 ± 1,062.7 vs RPT € 1,730.7 ± 1,656.8 vs WL € 2,462.7 ± 2,822.0 ) . Lower direct costs for GACT compared with RPT were due to lower costs from primary care visits and FM-related medications . The incremental cost effectiveness ratios were dominant in the completers ' analysis and remained robust in the sensitivity analyses . In conclusion , acceptance and commitment therapy appears to be a cost-effective treatment compared with RPT in patients with FM . PERSPECTIVE Decision-makers have to prioritize their budget on the treatment option that is the most cost effective for the management of a specific patient group . From government as well as health care perspectives , this study shows that a GACT is more cost effective than pharmacological treatment in management of FM Abstract Cognitive behavioral therapy ( CBT ) is believed to improve chronic pain problems by decreasing patient catastrophizing and increasing patient self-efficacy for managing pain . Mindfulness-based stress reduction ( MBSR ) is believed to benefit patients with chronic pain by increasing mindfulness and pain acceptance . However , little is known about how these therapeutic mechanism variables relate to each other or whether they are differentially impacted by MBSR vs CBT . In a r and omized controlled trial comparing MBSR , CBT , and usual care ( UC ) for adults aged 20 to 70 years with chronic low back pain ( N = 342 ) , we examined ( 1 ) baseline relationships among measures of catastrophizing , self-efficacy , acceptance , and mindfulness and ( 2 ) changes on these measures in the 3 treatment groups . At baseline , catastrophizing was associated negatively with self-efficacy , acceptance , and 3 aspects of mindfulness ( nonreactivity , nonjudging , and acting with awareness ; all P values < 0.01 ) . Acceptance was associated positively with self-efficacy ( P < 0.01 ) and mindfulness ( P values < 0.05 ) measures . Catastrophizing decreased slightly more posttreatment with MBSR than with CBT or UC ( omnibus P = 0.002 ) . Both treatments were effective compared with UC in decreasing catastrophizing at 52 weeks ( omnibus P = 0.001 ) . In both the entire r and omized sample and the sub sample of participants who attended ≥6 of the 8 MBSR or CBT sessions , differences between MBSR and CBT at up to 52 weeks were few , small in size , and of question able clinical meaningfulness . The results indicate overlap across measures of catastrophizing , self-efficacy , acceptance , and mindfulness and similar effects of MBSR and CBT on these measures among individuals with chronic low back pain Cognitive behavior therapy ( CBT ) has made important contributions to chronic pain management , but the process by which it is effective is not clear . Recently , strong arguments have been raised concerning the need for theory driven research to e.g. identify mechanisms of change in CBT and enhance the effectiveness
Output:
| There is also promising support for the cost-effectiveness of ACT ; however , the current evidence is still insufficient to establish firm conclusions about cost-effectiveness and the most efficient means of delivery . |
MS212189 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Background : TORCH ( Towards a Revolution in COPD Health ) is an international multicentre , r and omised , placebo-controlled clinical trial of inhaled fluticasone propionate/salmeterol combination treatment and its monotherapy components for maintenance treatment of moderately to severely impaired patients with chronic obstructive pulmonary disease ( COPD ) . The primary outcome is all-cause mortality . Cause-specific mortality and deaths related to COPD are additional outcome measures , but systematic methods for ascertainment of these outcomes have not previously been described . Methods : A Clinical Endpoint Committee ( CEC ) was tasked with categorising the cause of death and the relationship of deaths to COPD in a systematic , unbiased and independent manner . The key elements of the operation of the committee were the use of predefined principles of operation and definitions of cause of death and COPD -relatedness ; the independent review of cases by all members with development of a consensus opinion ; and a substantial infrastructure to collect medical information . Results : 911 deaths were review ed and consensus was reached in all . Cause-specific mortality was : cardiovascular 27 % , respiratory 35 % , cancer 21 % , other 10 % and unknown 8 % . 40 % of deaths were definitely or probably related to COPD . Adjudications were identical in 83 % of blindly re-adjudicated cases ( κ = 0.80 ) . COPD -relatedness was reproduced 84 % of the time ( κ = 0.73 ) . The CEC adjudication was equivalent to the primary cause of death recorded by the site investigator in 52 % of cases . Conclusion : A CEC can provide st and ardised , reliable and informative adjudication of COPD mortality that provides information which frequently differs from data collected from assessment by site investigators Background It is unclear whether elevated plasma C reactive protein ( CRP ) is causally related to chronic obstructive pulmonary disease ( COPD ) . The authors tested the hypothesis that genetically elevated plasma CRP causes COPD using a Mendelian r and omisation design . Methods The authors measured high-sensitivity CRP in plasma , genotyped for four single nucleotide polymorphisms in the CRP gene , and screened for spirometry-defined COPD and hospitalisation due to COPD in 7974 individuals from the Copenhagen City Heart Study and in 32 652 individuals from the Copenhagen General Population Study . Results Elevated plasma CRP > 3 mg/l compared with < 1 mg/l was associated with risk estimates of 1.8 and 2.8 for spirometry-based COPD and of 1.6 and 1.8 for hospitalisation due to COPD in the Copenhagen City Heart Study and the Copenhagen General Population Study , respectively . Genotype combinations of the four CRP polymorphisms were associated with up to a 62 % increase in plasma CRP . However , these genotype combinations did not associate with increased risk of COPD or hospitalisation due to COPD in either cohort or in the two cohorts combined . On instrumental variable analysis , a doubling of plasma CRP versus a doubling of genetically elevated CRP result ed in ORs for COPD of 1.27 ( 95 % CI 1.25 to 1.30 ) versus 1.01 ( 0.81 to 1.26 ) and for COPD hospitalisation of 1.47 ( 1.43 to 1.51 ) versus 0.82(0.59 to 1.13 ) . Conclusion Although elevated CRP is related to both a diagnosis of COPD and subsequent hospital admission , genetically elevated plasma CRP is not associated with an increased risk of clinical COPD . This suggests that the association between CRP levels and COPD is not causal Rationale : Chronic obstructive pulmonary disease ( COPD ) is associated with a 2–3-fold increase in the risk of ischaemic heart disease , stroke and sudden death . The mechanisms responsible for this association are not clear and appear to be independent of smoking history . Objective : We test the hypothesis that patients with COPD have increased arterial stiffness and blood pressure in comparison with age and smoking matched controls . Methods : In a prospect i ve case control study , we recruited 102 patients with COPD and 103 healthy controls matched for age and smoking status . Patients were assessed by clinical history and spirometry , with arterial stiffness and blood pressure determined using radial artery applanation tonometry and sphygmomanometry . Results : Patients with COPD had increased arterial stiffness compared with matched controls , with elevated augmentation pressure ( 17 ( 1 ) vs 14 ( 1 ) mm Hg ; p = 0.005 ) and a reduced time to wave reflection ( 131 ( 1 ) vs 137 ( 2 ) ms ; p = 0.004 ) . These differences were associated with increases in both diastolic ( 82 ( 1 ) vs 78 ( 1 ) mm Hg ; p = 0.005 ) and systolic blood pressure ( 147 ( 2 ) vs 132 ( 2 ) mm Hg ; p<0.001 ) . Serum C reactive protein concentrations were threefold higher in patients ( 6.1 ( 0.9 ) vs 2.3 ( 0.4 ) mg/l ; p = 0.001 ) . Data are presented as mean ( SEM ) . Conclusions : Patients with COPD have increased arterial stiffness and blood pressure in comparison with controls matched for age and smoking status . We speculate that increased systemic inflammation and vascular dysfunction could potentially explain the excess cardiovascular morbidity and mortality associated with COPD Background Health-related quality of life ( HRQL ) is considered as an important outcome parameter in patients with chronic diseases . This study aim ed to assess the role of disease-specific HRQL for long-term survival in patients of different diagnoses with chronic hypercapnic respiratory failure ( CHRF ) . Methods In a cohort of 231 stable patients ( chronic obstructive pulmonary disease ( COPD ) , n = 98 ; non- COPD ( obesity-hypoventilation syndrome , restrictive disorders , neuromuscular disorders ) , n = 133 ) with CHRF and current home mechanical ventilation ( HMV ) , HRQL was assessed by the disease-specific Severe Respiratory Insufficiency ( SRI ) question naire and its prognostic value was prospect ively evaluated during a follow-up of 2–4 years , using univariate and multivariate regression analysis . Results HRQL was more impaired in COPD ( mean ± SD SRI- summary score ( SRI-SS ) 52.5 ± 15.6 ) than non- COPD patients ( 67.6 ± 16.4 ; p < 0.001 ) . Overall mortality during 28.9 ± 8.8 months of follow-up was 19.1 % ( 31.6 % in COPD , 9.8 % in non- COPD ) . To identify the overall role of SRI , we first evaluated the total study population . SRI-SS and its subdomains ( except attendance symptoms and sleep ) , as well as body mass index ( BMI ) , leukocyte number and spirometric indices were associated with long-term survival ( p < 0.01 each ) . Of these , SRI-SS , leukocytes and forced expiratory volume in 1 s ( FEV1 ) turned out to be independent predictors ( p < 0.05 each ) . More specifically , in non- COPD patients SRI-SS and most of its subdomains , as well as leukocyte number , were related to survival ( p < 0.05 ) , whereas in patients with COPD only BMI and lung function but not SRI were predictive . Conclusion In patients with CHRF and HMV , the disease-specific SRI was an overall predictor of long-term survival in addition to established risk factors . However , the SRI predominantly beared information regarding long-term survival in non- COPD patients , while in COPD patients objective measures of the disease state were superior . This on one h and highlights the significance of HRQL in the long-term course of patients with CHRF , on the other h and it suggests that the predictive value of HRQL depends on the underlying disease Background In addition to smoking , acute exacerbations are considered to be a contributing factor to progression of chronic obstructive pulmonary disease ( COPD ) . However , these findings come from studies including active smokers , while results in ex-smokers are scarce and contradictory . The purpose of this study was to evaluate if frequent acute moderate exacerbations are associated with an accelerated decline in forced expiratory volume in one second ( FEV1 ) and impairment of functional and clinical outcomes in ex-smoking COPD patients . Methods A cohort of 100 ex-smoking patients recruited for a 2-year follow-up study was evaluated at inclusion and at 6-monthly scheduled visits while in a stable condition . Evaluation included anthropometry , spirometry , inspiratory capacity , peripheral capillary oxygen saturation , severity of dyspnea , a 6-minute walking test , BODE ( Body mass index , airflow Obstruction , Dyspnea , Exercise performance ) index , and quality of life ( St George ’s Respiratory Question naire and Chronic Respiratory Disease Question naire ) . Severity of exacerbation was grade d as moderate or severe according to health care utilization . Patients were classified as infrequent exacerbators if they had no or one acute exacerbation/year and frequent exacerbators if they had two or more acute exacerbations/year . R and om effects modeling , within hierarchical linear modeling , was used for analysis . Results During follow-up , 419 ( 96 % moderate ) acute exacerbations were registered . At baseline , frequent exacerbators had more severe disease than infrequent exacerbators according to their FEV1 and BODE index , and also showed greater impairment in inspiratory capacity , forced vital capacity , peripheral capillary oxygen saturation , 6-minute walking test , and quality of life . However , no significant difference in FEV1 decline over time was found between the two groups ( 54.7±13 mL/year versus 85.4±15.9 mL/year in frequent exacerbators and infrequent exacerbators , respectively ) . This was also the case for all other measurements . Conclusion Our results suggest that frequent moderate exacerbations do not contribute to accelerated clinical and functional decline in COPD patients who are ex-smokers Background Although it is known that patients with chronic obstructive pulmonary disease ( COPD ) generally do have an increased heart rate , the effects on both mortality and non-fatal pulmonary complications are unclear . We assessed whether heart rate is associated with all-cause mortality , and non-fatal pulmonary endpoints . Methods A prospect i ve cohort study of 405 elderly patients with COPD was performed . All patients underwent extensive investigations , including electrocardiography . Follow-up data on mortality were obtained by linking the cohort to the Dutch National Cause of Death Register and information on complications ( exacerbation of COPD or pneumonia ) by scrutinizing patient files of general practitioners . Multivariable cox regression analysis was performed . Results During the follow-up 132 ( 33 % ) patients died . The overall mortality rate was 50/1000 py ( 42–59 ) . The major causes of death were cardiovascular and respiratory . The relative risk of all-cause mortality increased with 21 % for every 10 beats/minute increase in heart rate ( adjusted HR : 1.21 [ 1.07–1.36 ] , p = 0.002 ) . The incidence of major non-fatal pulmonary events was 145/1000 py ( 120–168 ) . The risk of a non-fatal pulmonary complication increased non-significantly with 7 % for every 10 beats/minute increase in resting heart rate ( adjusted HR : 1.07 [ 0.96–1.18 ] , p = 0.208 ) . Conclusions Increased resting heart rate is a strong and independent risk factor for all-cause mortality in elderly patients with COPD . An increased resting heart rate did not result in an increased risk of exacerbations or pneumonia . This may indicate that the increased mortality risk of COPD is related to non-pulmonary causes . Future r and omized controlled trials are needed to investigate whether heart-rate lowering agents are worthwhile for COPD patients RATIONALE Accurate prediction of mortality helps select patients for interventions aim ed at improving outcome . OBJECTIVES Because chronic obstructive pulmonary disease is characterized by low- grade systemic inflammation , we hypothesized that addition of inflammatory biomarkers to established predictive factors will improve accuracy . METHODS A total of 1,843 patients enrolled in the Evaluation of COPD Longitudinally to Identify Predictive Surrogate Endpoints study were followed for 3 years . Kaplan-Meier curves , log-rank analysis , and Cox proportional hazards analyses determined the predictive value for mortality of clinical variables , while C statistics assessed the added discriminative power offered by addition of biomarkers . MEASUREMENTS AND MAIN RESULTS At recruitment we measured anthropometrics , spirometry , 6-minute walk distance , dyspnea , BODE index , history of hospitalization , comorbidities , and computed tomography scan emphysema . White blood cell and neutrophil counts , serum or plasma levels of fibrinogen , chemokine lig and 18 , surfactant protein D , C-reactive protein , Clara cell secretory protein-16 , IL-6 and -8 , and tumor necrosis factor
Output:
| Shorter 6MWD and elevated fibrinogen and CRP were associated with exacerbation , and shorter 6MWD , higher heart rate , CRP and IL-6 were associated with hospitalisation .
Few studies examined associations with musculoskeletal measures .
Conclusion Findings suggest 6MWD , heart rate , CRP , fibrinogen and WCC are associated with clinical outcomes in patients with stable COPD . |
MS212190 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Fifty-four patients with acute cerebral infa rct ion were included in a double-blind study to evaluate Decadron ® as therapy . When comparison of patients with similar levels of consciousness was made , there was no significant difference between those patients receiving Decadron ® and those receiving placebo therapy . Three patients developed gastrointestinal tract bleeding in the placebo group , but there were none in the Decadron ® -treated group . There was no good correlation between the clinical state of the patient and the CSF pressure , either on admission or during the 14-day course of the study Dexamethasone and a placebo were compared as treatment for 40 patients with intracerebral hemorrhage . Of 19 patients receiving dexamethasone , 17 ( 89.5 % ) died during their hospital admission . Of 21 patients receiving a placebo , 16 ( 76.2 % ) died . The mortality rate was 100 % in 15 patients in the dexamethasone-treated group who were in coma or deep stupor on admission , and the mortality rate was 92 % in 12 patients with similar levels of consciousness who received a placebo . Several parameters of the neurological examination showed an improved quality of survival in the Decadron ® -treated group , but this was found only at certain days in the study . No overall statistically significant difference was found between the two therapies In this study with r and omized controls , we administered fludrocortisone acetate to 46 of 91 patients with subarachnoid hemorrhage in an attempt to prevent excessive natriuresis and plasma volume depletion . Fludrocortisone significantly reduced the frequency of a negative sodium balance during the first 6 days ( from 63 % to 38 % , p = 0.041 ) . A negative sodium balance was significantly correlated with decreased plasma volume during both the first 6 days ( p = 0.014 ) and during the entire 12-day study period ( p = 0.004 ) . Although fludrocortisone treatment tended to diminish the decrease in plasma volume , the difference was not significant ( p = 0.188 ) . More patients in the control group developed cerebral ischemia ( 31 % vs. 22 % ) and , consequently , more control patients were treated with plasma volume exp and ers ( 24 % vs. 15 % ) , which may have masked the effects of fludrocortisone on plasma volume . Fludrocortisone therefore reduces natriuresis and remains of possible therapeutic benefit in the prevention of delayed cerebral ischemia after aneurysmal subarachnoid hemorrhage In an open , r and omized anterospective , comparative study on encephalomalacias it was shown that with regard to the parameter of rehabilitation progress in the degree of paralysis , the patients treated with cortisone had a significantly better performance at the 5 % level . The main point of attack of cortisone appears to be in the early phase of the insult ( first 5 days ) . It seems unlikely that edema control is the only active principle . More probably this is an additional effect on cell metabolism . From these results it seems logical to continue to follow up the acute treatment of cerebral insult with cortisone and search for an optimal dosage and better confirmation A prospect i ve study of 93 acute stroke patients r and omly selected by type of antiedema treatment given ( hypertonic glicerol infusion plus dexamethasone versus dexamethasone alone ) failed to elicit any statistically significant difference between the two treatments on survival rates and quality of survival 7 and 30 days after the stroke Steroid treatment is widely used in acute cerebral infa rct ion yet its value is controversial . High dose dexamethasone ( 480 mg over 12 days ) was given in a double blind , r and omised controlled trial to 113 consecutive eligible patients with acute cerebral infa rct ion admitted to an acute stroke unit . Those with stroke for more than 48 hours , known embolic sources , diabetes , and infection were excluded . Death and quality of survival were recorded over 21 days . The active drug group ( 54 patients ) matched the placebo group ( 59 patients ) for age , initial stroke score , delay in beginning treatment , and other relevant variables . The two groups did not differ significantly in death rate or quality of survivorship . The small difference in mortality between the two groups may have represented a marginal therapeutic effect , which might reach significance in a larger sample . The widespread use of steroids in response to such a marginal therapeutic gain would expose large numbers of patients with stroke to more serious hazards of steroid treatment and convert patients who would otherwise have died into neurovegetative survivors . High dose steroid treatment was ineffective in ischaemic stroke , and the data suggest that further evaluation by a larger multicentre trial is not justified Intramuscular dexamethasone combined with intravenous low-molecular-weight dextran ( dextran 40 ) was compared with placebo in 40 patients with acute ischaemic cerebral infa rct ion . A double-blind procedure was used . Dexamethasone was given for up to 14 days and dextran 40 for up to three days after the infa rct ion . A weighted scoring system was used to evaluate neurological state and mobility . There were no differences in mortality or in improvement of the neurological or mobility scores between the two groups Fifty-three patients with acute cerebral infa rct ion were treated in a double-blind study with either dexamethasone or placebo within 24 hours of the onset of stroke . Forty-one of these survived for longer than 28 days , and the patients treated with the steroid fared slightly worse than those treated with placebo at the end of this time . Two of the five patients who died in the placebo group died of cerebral edema , compared with three out of seven patients who died in the steroid group . Infectious complications , gastrointestinal hemorrhage , and occasional serious exacerbations of diabetes occurred more commonly in the steroid group In the absence of universally accepted criteria for the medical treatment of stroke , we made a rigorously r and omized comparative study of different treatments in 300 patients . One group of patients received only a general supportive treatment design ed to ensure adequate supplies of water , electrolytes and calories , plus whatever was needed to prevent infection and correct extant associated pathology . Three other groups of patients were treated in the same way but were also given , respectively , one of the following medications : Hydergine ( S and oz ) ( a mixture of three ergot alkaloids ) , dexamethasone , and mannitol . No statistically significant difference emerged among any of the treatment groups and the reference group in terms of objective therapeutic results . The authors concluded that , at least with the dosage used in this study , none of the treatments proved more useful than conventional supportive therapy in the first 10 days after a stroke OBJECTIVE Hospital management of acute ischemic stroke varies greatly within and between different countries . This study assesses the current practice s and opinions of doctors in China routinely involved in the treatment of stroke , and compares them with those of British doctors . METHODS Question naires about the usual management of acute ischemic stroke were sent to 247 Chinese hospitals ( mostly urban ) collaborating in an acute stroke trial , seeking responses from five doctors ( one consultant , two registrars , and two house officers ) in each . After one mailing , 1,095 doctors ( 89 % ) responded . RESULTS Sixty-nine percent of the hospitals had computed tomography scanners , and 88 % of the doctors in those hospitals reported that they would routinely scan acute stroke patients ( 78 % usually within 24 hours of admission and 22 % only later ) . Sixty-two percent of doctors reported average hospital stays of 2 to 4 weeks , whereas 36 % reported longer average stays . Treatments reported to be used routinely within the first 48 hours of acute ischemic stroke included glycerol or mannitol ( 69 % of doctors ) , Chinese herb products ( 66 % ) , calcium antagonists ( 54 % ) , and aspirin ( 53 % ) ; for each of these treatments , over 70 % of all doctors believed it produced definite benefit . Reported routine use of dextran ( 44 % ) , snake venom ( 32 % ) , " photo-therapy " ( 22 % ) , and steroids ( 19 % ) was also moderately common , and about half of all doctors believed each was beneficial . In contrast , routine use of thrombolytic agents ( 4 % ) or anticoagulants ( 1 % ) was uncommon . Only one third of the doctors reported active treatment of hypertension immediately after admission . CONCLUSIONS Comparison with a similar survey in Britain showed reported use of most treatments for acute ischemic stroke was more extensive in China , but that within both countries there was wide variation . The substantial variations in clinical practice both within and between China , the United Kingdom and other countries reflect , at least in part , the substantial uncertainty about the effectiveness of many of the possible treatments for acute ischemic stroke . Large-scale r and omized evidence is needed to confirm or refute the efficacy of these and newer treatments for acute stroke The National Institute of Neurological and Communicative Disorders and Stroke initiated the Stroke Data Bank , which is a multicenter project to prospect ively collect data on the clinical course and sequelae of stroke . Additional objectives were to provide information that would enable a st and ard diagnostic clinical evaluation , to identify prognostic factors , and to provide planning data for future studies . A brief description of the structure and methods precede the baseline characterization of 1,805 patients enrolled in the Stroke Data Bank between July 1983 and June 1986 . Two thirds of these patients were admitted within 24 hours after stroke onset . Medical history , neurologic history , and hospitalization summaries are presented separately for the following stroke subtypes : infa rct ion , unknown cause ; embolism from cardiac source ; infa rct ion due to atherosclerosis ; lacune ; parenchymatous or intracerebral hemorrhage ; subarachnoid hemorrhage ; and other . The utility and limitations of these data are discussed MRC CRASH is a r and omised controlled trial ( IS RCT N74459797 ) of the effect of corticosteroids on death and disability after head injury . We r and omly allocated 10,008 adults with head injury and a Glasgow Coma Scale score of 14 or less , within 8 h of injury , to a 48-h infusion of corticosteroid ( methylprednisolone ) or placebo . Data at 6 months were obtained for 9673 ( 96.7 % ) patients . The risk of death was higher in the corticosteroid group than in the placebo group ( 1248 [ 25.7 % ] vs 1075 [ 22.3 % ] deaths ; relative risk 1.15 , 95 % CI 1.07 - 1.24 ; p=0.0001 ) , as was the risk of death or severe disability ( 1828 [ 38.1 % ] vs 1728 [ 36.3 % ] dead or severely disabled ; 1.05 , 0.99 - 1.10 ; p=0.079 ) . There was no evidence that the effect of corticosteroids differed by injury severity or time since injury . These results lend support to our earlier conclusion that corticosteroids should not be used routinely in the treatment of head injury 10 percent glycerol was given for 6 days to 30 patients who had had acute ischaemic cerebral infa rct ion , and the results were compared with those obtained after treating 31 similar patients with dexamethasone ( 16 mg . per 24 hours for 6 days ) . 1 patient treated with glycerol died of haemoglobinuria and acute renal failure . 6 patients treated with dexamethasone died--3 from cerebral oedema and 3 from non-neurological complications ( pulmonary embolism , myocardial infa rct ion , and aspiration pneumonia ) . Improvement was significantly greater in the glycerol group after 8 and 15 days . No improvement was noted using either glycerol or dexamethasone in 7 patients with spontaneous intracerebral haemorrhage Over 13 months 118 patients admitted to hospital with acute stroke were allocated at r and om to treatment with either dexamethasone or placebo . At one year there was no significant difference in the numbers of survivors or in the quality of life between the two groups . The results suggest that there is no indication for the routine administration of dexamethasone to a heterogeneous group of patients with stroke To evaluate the efficacy of dexamethasone for treatment of primary supratentorial intracerebral hemorrhage , we studied 93 patients 40 to 80 years old , using a double-blind r and omized block design . After the subjects were stratified according to their level of consciousness ( Glasgow Coma Scale ) , those with objective ly documented primary supratentorial intracerebral hemorrhage were r and omly assigned to either dexamethasone or placebo . For ethical reasons , three interim analyses were planned , to permit early termination of the trial if one study group did better than the other . During the third interim analysis , the death rate at the 21st day was identical in the two groups ( dexamethasone vs. placebo , 21 of 46 vs. 21 of 47 ; chi-square = 0.01 , P = 0.93 ) . In contrast , the rate of complications ( mostly infections and complications of diabetes ) was much higher in the de
Output:
| Treatment did not appear to improve functional outcome in survivors .
The only adverse effects reported were small numbers of gastrointestinal bleeds , infections and deterioration of hyperglycaemia across both groups .
There is not enough evidence to evaluate corticosteroid treatment for people with acute presumed ischaemic stroke . |
MS212191 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: BACKGROUND Elevated plasma total homocysteine concentration may be a risk factor for cognitive decline and Alzheimer disease , but data from prospect i ve studies are limited . Further , high homocysteine levels are associated with low vitamin status , and it is unknown whether it is homocysteine toxicity or vitamin insufficiency that is responsible for the observed cognitive dysfunction . METHODS We performed cross-sectional and longitudinal analyses of a cohort of 499 high-functioning community-dwelling persons aged 70 to 79 years to determine the effect of homocysteine and related vitamin plasma concentrations on cognitive function and cognitive decline . Nonfasting plasma concentrations of homocysteine , folate , vitamin B(6 ) , and vitamin B(12 ) were measured at baseline . Summary measures of cognitive function were created from tests of multiple cognitive domains administered at baseline and again after 7 years . RESULTS In cross-sectional analyses investigating each variable separately , subjects with elevated homocysteine levels , or low levels of folate or vitamin B(6 ) , demonstrated worse baseline cognitive function . In longitudinal analyses , after adjusting for multiple covariates , including homocysteine , those in the bottom quartile of folate had a 1.6-fold increased risk ( 95 % confidence interval : 1.01 to 2.31 ; P = 0.04 ) of being in the worst quartile of 7-year cognitive decline . Low folate levels largely accounted for a trend towards greater cognitive decline with elevated homocysteine level . CONCLUSION In high-functioning older adults , low folate levels appear to be a risk factor for cognitive decline . The risk of developing cognitive decline might be reduced through dietary folate intake Based on research demonstrating associations between folate , B-12 and B-6 vitamins and cognition and mood , we investigated the effects of short-term supplementation in 211 healthy younger , middle-aged and older women who took either 750 microg of folate , 15 microg of vitamin B-12 , 75 mg of vitamin B-6 or a placebo daily for 35 d. In addition , we examined associations between dietary intake of these vitamins and cognition and mood . Usual dietary intake status was estimated using a retrospective , self-report , quantified food frequency question naire . Participants completed alternate forms of st and ardized tests of cognitive processing re sources , memory , executive function , verbal ability and self-report mood measures before and after supplementation . Supplementation had a significant positive effect on some measures of memory performance only , and no effect on mood . Dietary intake status was associated with speed of processing , recall and recognition and verbal ability BACKGROUND Deficiencies of vitamin B-12 , folic acid , and vitamin B-6-as defined by laboratory measures -occur in 10 - 20 % of elderly subjects . The clinical significance remains unresolved . OBJECTIVE The objective was to explore any association between vitamin status and vitamin treatment and movement and cognitive performance in elderly subjects . DESIGN Community-dwelling subjects ( n = 209 ) with a median age of 76 y were r and omly assigned to daily oral treatment with 0.5 mg cyanocobalamin , 0.8 mg folic acid , and 3 mg vitamin B-6 or placebo ( double blind ) for 4 mo . Movement and cognitive performance tests were performed before and after treatment . RESULTS A high plasma total homocysteine ( tHcy ) concentration ( > or = 16 micromol/L ) was found in 64 % of men and in 45 % of women , and a high serum methylmalonic acid ( MMA ) concentration ( > or = 0.34 micromol/L ) was found in 11 % of both sexes . Movement time , digit symbol , and block design ( adjusted for age , sex , smoking , and creatinine ) correlated independently with plasma tHcy ( P < 0.01 , < 0.05 , and < 0.01 , respectively ) ; the simultaneity index and block design correlated with serum MMA ( P < 0.05 for both ) . Vitamin therapy significantly decreased plasma tHcy ( 32 % ) and serum MMA ( 14 % ) . No improvements were found in the movement or cognitive tests compared with placebo . Neither vitamin therapy nor changes in plasma tHcy , serum MMA , serum vitamin B-12 , plasma folate , or whole-blood folate correlated with changes in movement or cognitive performance . CONCLUSIONS High plasma tHcy and serum MMA were prevalent and correlated inversely with movement and cognitive performance . Oral B vitamin treatment normalized plasma tHcy and serum MMA concentrations but did not affect movement or cognitive performance . This might have been due to irreversible or vitamin-independent neurocognitive decline or to an insufficient dose or duration of vitamins OBJECTIVE To explore the associations of low serum levels of vitamin B(12 ) and folate with AD occurrence . METHODS A population -based longitudinal study in Sweden , the Kungsholmen PROJECT A r and om sample of 370 nondemented persons , aged 75 years and older and not treated with B(12 ) and folate , was followed for 3 years to detect incident AD cases . Two cut-off points were used to define low levels of vitamin B(12 ) ( < or = 150 and < or = 250 pmol/L ) and folate ( < or = 10 and < or = 12 nmol/L ) , and all analyses were performed using both definitions . AD and other types of dementia were diagnosed by specialists according to DSM-III-R criteria . RESULTS When using B(12 ) < or = 150 pmol/L and folate < or = 10 nmol/L to define low levels , compared with people with normal levels of both vitamins , subjects with low levels of B(12 ) or folate had twice higher risks of developing AD ( relative risk [ RR ] = 2.1 , 95 % CI = 1.2 to 3.5 ) . These associations were even stronger in subjects with good baseline cognition ( RR = 3.1 , 95 % CI = 1.1 to 8.4 ) . Similar relative risks of AD were found in subjects with low levels of B(12 ) or folate and among those with both vitamins at low levels . A comparable pattern was detected when low vitamin levels were defined as B(12 ) < or = 250 pmol/L and folate < or = 12 nmol/L. CONCLUSIONS This study suggests that vitamin B(12 ) and folate may be involved in the development of AD . A clear association was detected only when both vitamins were taken into account , especially among the cognitively intact subjects . No interaction was found between the two vitamins . Monitoring serum B(12 ) and folate concentration in the elderly may be relevant for prevention of AD BACKGROUND Associations between vitamin B-12 deficiency and impaired cognitive function and depression have been reported . METHODS A r and omized placebo controlled study including 140 individuals with an increased plasma methylmalonic acid ( 0.40 - 2.00 micromol/l ) not previously treated with vitamin B-12 . Cognitive function was assessed by the Cambridge Cognitive Examination ( CAMCOG ) , Mini-Mental State Examination ( MMSE ) , and a 12-words learning test . Symptoms of depression were evaluated by the Major Depression Inventory . The main outcome measure was change in cognitive function and depression score from baseline to follow-up 3 months later . RESULTS At baseline 78 ( 56 % ) individuals had cognitive impairment judged from the CAMCOG score and 40 ( 29 % ) according to the MMSE ; 18 ( 13 % ) individuals had symptoms of depression . No improvement was found in cognitive function comparing the treatment and placebo group ( total CAMCOG score : P = 0.43 ) , nor among individuals with only slightly impaired cognitive function ( n = 44 , total CAMCOG score : P = 0.42 ) . The treatment group did not improve in depression score as compared to the placebo group ( P = 0.18 ) . LIMITATIONS The duration of impaired cognitive function was unknown . CONCLUSIONS A high proportion of individuals with an increased plasma methylmalonic acid had impaired cognitive function , and a rather high prevalence of depression was observed . However , vitamin B-12 treatment did not improve cognitive function or symptoms of depression within the 3-months study period Routine determination of serum vitamin B12 levels is generally recommended as part of the screening of demented patients , based on the notion that vitamin B12 deficiency is one of the causes of reversible dementia . We studied the effects of vitamin B12 replacement therapy in a prospect i ve longitudinal study at a memory clinic , with special emphasis on assessment of severity of dementia : not only cognitive deterioration , but also disability in the activities of daily life , behavioural problems , and the burden experienced by the caregiver were examined using instruments of proven validity . In a series of 170 consecutive patients with dementia , subnormal serum vitamin B12 levels were found in 26 cases ( 15 % ) ; all but one fulfilled diagnostic criteria for possible Alzheimer 's disease . Cobalamin supplementation was given to all patients and the effect was evaluated after 6 months . When the size and pattern of individual change scores , and the mean change scores on all instruments were taken into account , functioning after replacement therapy was not improved . When change scores of treated patients were compared with those of patients with Alzheimer 's disease ( n = 69 ) , vitamin B12 replacement did not result in slowing of the progression of dementia . Contrary to widely accepted beliefs , subnormal serum vitamin B12 levels are not a ( quantitatively ) important cause of reversible dementia BACKGROUND Associations between low levels of folate and vitamin B12 and cognitive impairment in patients with dementia have been reported . Some studies revealed correlations between low levels of vitamin B12 and behavioural and psychological signs and symptoms of dementia ( BPSD ) in Alzheimer 's disease ( AD ) patients . Given the lack of studies in frontotemporal dementia ( FTD ) and on folate and given the method ological shortcomings of former publications , we set up a prospect i ve study . METHODS At inclusion , AD ( n=152 ) and FTD ( n=28 ) patients underwent a neuropsychological examination . Behaviour was assessed using a battery of behavioural assessment scales . Determination of serum vitamin B12 and red cell folate levels were performed within a time frame of two weeks of inclusion . RESULTS In both patient groups , significantly negative correlations between levels of serum vitamin B12 and red cell folate and the degree of cognitive deterioration were found . No correlations with BPSD were found in the AD patient group . In FTD patients , levels of vitamin B12 were negatively correlated with both hallucinations ( p=0.022 ) and diurnal rhythm disturbances ( p=0.036 ) . CONCLUSIONS The observed negative correlations between levels of vitamin B12 and folate and cognitive impairment in both AD and FTD patients , raise the possibility of a non-specific etiological role . Although levels of vitamin B12 and folate did not correlate with BPSD in AD patients , negative correlations between serum vitamin B12 levels and BPSD in FTD patients were revealed . Decreased serum vitamin B12 levels may predispose FTD patients to develop hallucinations and diurnal rhythm disturbances BACKGROUND Mild cobalamin ( Cbl ) deficiency is frequently found in older persons and is associated with cognitive and cerebral abnormalities . The effects of Cbl supplementation on these abnormalities are largely unknown . METHODS In a single-blind , placebo-controlled intervention study , 16 healthy community-dwelling elderly subjects with low plasma Cbl concentration and no cognitive impairments were studied . Subjects underwent 1 month of treatment with placebo , followed by 5 months of treatment with intramuscular injections of hydroxycobalamin . Before and after measurements of plasma cobalamin , total homocysteine ( tHcy ) , methylmalonic acid ( MMA ) , quantitative electroencephalograph ( qEEG ) , and psychometric tests were taken . RESULTS After Cbl supplementation , plasma Cbl concentrations increased , and plasma MMA and tHcy concentrations decreased . The performance on the Verbal Word Learning Test , Verbal Fluency and Similarities improved . qEEG showed more fast activity and less slow activity . Lower plasma tHcy concentrations were related to increased fast activity on qEEG on the one h and and improved performance on the Verbal Word Learning Test and Similarities on the other . Increased fast or decreased slow activity on qEEG was associated with improved performance on the Verbal Word Learning Test , Similarities and Verbal Fluency . CONCLUSIONS Electrographic signs of improved cerebral function and improved cognitive function were found after Cbl supplementation in older subjects with low plasma Cbl concentrations who were free of significant cognitive impairment . These improvements were related to a reduction of plasma tHcy concentration OBJECTIVES To investigate the effect of cobalamin/folate supplementation on cognitive function in elderly patients with dementia . METHOD The cobalamin/folate status of the patients was evaluated by measuring plasma homocysteine , serum methylmalonic acid , serum cobalamin and blood folate . Thirty-three patients were studied and repeatedly assessed with the Mini-Mental State Examination ( MMSE ) and ' A short cognitive performance test for assessing memory and attention ' ( SKT )
Output:
| Association of dietary intake levels of B vitamins with age-related neurodegenerative diseases and cognitive |
MS212192 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: OBJECTIVES To investigate the effect of bracing and taping on selected electromyographic , kinematic , and kinetic variables when l and ing from a jump . METHODS Fifteen netball players performed a jump , so as to l and on their dominant limb on a force plate . Electromyographic activity was recorded from the gastrocnemius , tibialis anterior , and peroneus longus muscles . Subjects were also filmed and measures of rearfoot motion were derived . RESULTS Significantly less electromyographic activity ( p<0.007 ) was observed from the gastrocnemius and peroneus longus muscle groups when subjects were braced . No other significant electromyographical findings were observed . Peak vertical ground reaction force and time to peak for vertical ground reaction force were not affected by bracing and taping , nor were the rearfoot and Achilles tendon angles at foot strike . CONCLUSIONS The effect of bracing and taping on the selected biomechanics variables associated with l and ing was specifically limited to a reduction in muscle action , particularly for the braced condition . Netball players can be confident that the biomechanics of their l and ing patterns will not be altered whether they choose to wear a brace or tape their ankle joints PURPOSE Ankle joint dorsiflexion contributes to energy absorption during l and ing , but wearing ankle stabilizers is known to restrict passive measures of dorsiflexion . This study compared the effects of various ankle stabilizers on ankle joint kinematics during soft and stiff l and ings . METHODS Subjects ( N = 14 ) performed two-legged l and ings off a 0.59-m platform . Kinematics of the right ankle were calculated from a sagittal plane video recording ( 120 Hz ) . Five soft and five stiff l and ings were performed in five ankle stabilizer conditions ( no stabilizer , taping , Swede-O , AirCast , and Active Ankle ) , a total of 50 trials per subject . Style and stabilizer conditions were r and omized across subjects . Each subject 's five-trial mean value of selected kinematic variables for each l and ing style/stabilizer condition was entered into a two-way repeated MANOVA ( alpha = 0.05 ) . RESULTS Differences between soft and stiff l and ing conditions were similar to those reported in the literature . Compared with the No stabilizer condition , most stabilizer conditions significantly reduced ankle dorsiflexion ROM and angular velocity during l and ing . CONCLUSIONS The results indicate that some ankle stabilizers adversely affect ankle joint kinematics during l and ing BACKGROUND Lower extremity stiffness is thought to be an important factor in musculoskeletal performance . However , too little or too much stiffness is believed to increase the risk of musculoskeletal injury . PURPOSE To provide a current up date of the lower extremity stiffness literature as it pertains to both performance and injury . SUMMARY It appears that increased stiffness is beneficial to performance . As well it appears that there may be an optimal amount of stiffness that allows for injury-free performance . There is some evidence that increased stiffness may be related to bony injuries and decreased stiffness may be associated with soft tissue injuries . Further investigations should evaluate the relationship between stiffness and injury prospect ively . Initial reports suggest that stiffness can be modified in response to the external environment or verbal cues . RELEVANCE A greater underst and ing of the role of stiffness in both performance and injury will provide a stronger foundation for the development of optimal training intervention programs OBJECTIVE : To test the feasibility of creating a valid and reliable checklist with the following features : appropriate for assessing both r and omised and non-r and omised studies ; provision of both an overall score for study quality and a profile of scores not only for the quality of reporting , internal validity ( bias and confounding ) and power , but also for external validity . DESIGN : A pilot version was first developed , based on epidemiological principles , review s , and existing checklists for r and omised studies . Face and content validity were assessed by three experienced review ers and reliability was determined using two raters assessing 10 r and omised and 10 non-r and omised studies . Using different raters , the checklist was revised and tested for internal consistency ( Kuder-Richardson 20 ) , test-retest and inter-rater reliability ( Spearman correlation coefficient and sign rank test ; kappa statistics ) , criterion validity , and respondent burden . MAIN RESULTS : The performance of the checklist improved considerably after revision of a pilot version . The Quality Index had high internal consistency ( KR-20 : 0.89 ) as did the subscales apart from external validity ( KR-20 : 0.54 ) . Test-retest ( r 0.88 ) and inter-rater ( r 0.75 ) reliability of the Quality Index were good . Reliability of the subscales varied from good ( bias ) to poor ( external validity ) . The Quality Index correlated highly with an existing , established instrument for assessing r and omised studies ( r 0.90 ) . There was little difference between its performance with non-r and omised and with r and omised studies . Raters took about 20 minutes to assess each paper ( range 10 to 45 minutes ) . CONCLUSIONS : This study has shown that it is feasible to develop a checklist that can be used to assess the method ological quality not only of r and omised controlled trials but also non-r and omised studies . It has also shown that it is possible to produce a checklist that provides a profile of the paper , alerting review ers to its particular method ological strengths and weaknesses . Further work is required to improve the checklist and the training of raters in the assessment of external validity Objectives : To determine if measurements of static lower limb alignment are related to lower limb injury in recreational runners . Methods : Static lower limb alignment was prospect ively measured in 87 recreational runners . They were observed for the following six months for any running related musculoskeletal injuries of the lower limb . Injuries were defined according to six types : R1 , R2 , and R3 injuries caused a reduction in running mileage for one day , two to seven days , or more than seven days respectively ; S1 , S2 , and S3 injuries caused stoppage of running for one day , two to seven days , or more than seven days respectively . Results : At least one lower limb injury was suffered by 79 % of the runners during the observation period . When the data for all runners were pooled , 95 % confidence intervals calculated for the differences in the measurements of lower limb alignment between the injured and non-injured runners suggested that there were no differences . However , when only runners diagnosed with patellofemoral pain syndrome ( n = 6 ) were compared with non-injured runners , differences were found in right ankle dorsiflexion ( 0.3 to 6.1 ) , right knee genu varum ( −0.9 to −0.3 ) , and left forefoot varus ( −0.5 to −0.4 ) . Conclusions : In recreational runners , there is no evidence that static biomechanical alignment measurements of the lower limbs are related to lower limb injury except patellofemoral pain syndrome . However , the effect of static lower limb alignment may be injury specific CONTEXT Long-term effects of ankle bracing on lower extremity kinematics and kinetics are unknown . Ankle motion restriction may negatively affect the body 's ability to attenuate ground reaction forces ( GRFs ) . OBJECTIVE To evaluate the immediate and long-term effects of ankle bracing on lower extremity kinematics and GRFs during a jump l and ing . DESIGN Experimental mixed model ( 2 [ group ] x 2 [ brace ] x 2 [ time ] ) with repeated measures . SETTING Sports medicine research laboratory . PATIENTS OR OTHER PARTICIPANTS A total of 37 healthy subjects were assigned r and omly to either the intervention ( n = 11 men , 8 women ; age = 19.63 + /- 0.72 years , height = 176.05 + /- 10.58 cm , mass = 71.50 + /- 13.15 kg ) or control group ( n = 11 men , 7 women ; age = 19.94 + /- 1.44 years , height = 179.15 + /- 8.81 cm , mass = 74.10 + /- 10.33 kg ) . INTERVENTION(S ) The intervention group wore braces on both ankles and the control group did not wear braces during all recreational activities for an 8-week period . MAIN OUTCOME MEASURE(S ) Initial ground contact angles , maximum joint angles , time to reach maximum joint angles , and joint range of motion for sagittal-plane knee and ankle motion were measured during a jump-l and ing task . Peak vertical GRF and the time to reach peak vertical GRF were assessed also . RESULTS While participants were wearing the brace , ankle plantar flexion at initial ground contact ( brace = 35 degrees + /- 13 degrees , no brace = 38 degrees + /- 15 degrees , P = .024 ) , maximum dorsiflexion ( brace = 21 degrees + /- 7 degrees , no brace = 22 degrees + /- 6 degrees , P = .04 ) , dorsiflexion range of motion ( brace = 56 degrees + /- 14 degrees , no brace = 59 degrees + /- 16 degrees , P = .001 ) , and knee flexion range of motion ( brace = 79 degrees + /- 16 degrees , no brace = 82 degrees + /- 16 degrees , P = .036 ) decreased , whereas knee flexion at initial ground contact increased ( brace = 12 degrees + /- 9 degrees , no brace = 9 degrees + /- 9 degrees , P = .0001 ) . Wearing the brace for 8 weeks did not affect any of the outcome measures , and the brace caused no changes in vertical GRFs ( P > .05 ) . CONCLUSIONS Although ankle sagittal-plane motion was restricted with the brace , knee flexion upon l and ing increased and peak vertical GRF did not change . The type of lace-up brace used in this study appeared to restrict ankle motion without increasing knee extension or vertical GRFs and without changing kinematics or kinetics over time The purpose of this prospect i ve study was to determine whether an association exists between foot structure and the development of musculoskeletal overuse injuries . The study group was a well-defined cohort of 449 trainees at the Naval Special Warfare Training Center in Coronado , California . Before beginning training , measurements were made of ankle motion , subtalar motion , and the static ( st and ing ) and dynamic ( walking ) characteristics of the foot arch . The subjects were tracked prospect ively for injuries throughout training . We identified risk factors that predispose people to lower extremity overuse injuries . These risk factors include dynamic pes planus , pes cavus , restricted ankle dorsiflexion , and increased hindfoot inversion , all of which are subject to intervention and possible correction OBJECTIVE The aim of the present investigation was to test the stability of 10 different ankle braces under passive and rapidly induced loading conditions in a population suffering from chronic ankle instability in order to provide objective information to choose or recommend an appropriate model for specific needs . In addition , the relationship between passive and rapidly induced testing of the stabilizing effect against inversion was evaluated to identify if passive support characteristics of braces are reflected under rapidly induced conditions . DESIGN An experimental in vivo study with a repeated- measures design was used . BACKGROUND Ankle braces are commonly used for treatment , rehabilitation , and prevention of ankle injuries . A variety of products exists but there is few information available to assist clinicians , physiotherapists and coaches as well as consumers in choosing a brace on a basis of objective information . Furthermore , there is a lack of studies that provide data for both passively and rapidly induced movement of the ankle joint when using different ankle braces . METHODS Twenty-four subjects with chronic ankle instability participated in the project . Passive ankle range of motion measurements were performed in a custom-built fixture and simulated inversion sprains were elicited on a tilting platform . RESULTS The tested braces restrict range of motion significantly compared to the no-brace condition for both the passively and rapidly induced inversion and marked differences between braces were revealed . A close relationship between passive and rapidly induced test results for inversion was found . CONCLUSIONS Passive as well as rapidly induced stability tests provide a basis of objective information to describe the characteristics of different ankle braces . Combined results of passive and rapidly induced inversion as well as correlation between results demonstrate that passive support characteristics of braces are reflected under rapidly induced conditions but the amount of restriction is reduced . Therefore , caution should be taken when recommending braces for applications under dynamic circumstances only on the basis of passive support characteristics . RELEVANCE A basis of information regarding the stability characteristics of different ankle braces under passive and rapidly induced conditions will help the clinician and consumer in choosing the most appropriate brace model for specific use . The results also provide more insights into factors that influence stability characteristics of ankle braces STUDY DESIGN Single-group repeated- measures experimental design . OBJECTIVES The purpose of this study was to evaluate the effects of prophylactic ankle stabilization on vertical ground reaction forces before and after treadmill jogging . BACKGROUND Previous research has demonstrated acute effects of ankle taping and bracing on ankle joint kinematics and vertical ground reaction forces during drop l and ings . Based on the number of investigations demonstrating increased range of motion of the braced or taped ankle following exercise , it may be plausible that the aforementioned l and ing alterations may return to normal following an exercise bout . METHODS AND MEASURES Fourteen healthy recreational participants performed stiff and soft drop l and ings before and after a 20-minute treadmill exercise bout under 3 different ankle stabilizer conditions ( no stabilizer , ankle brace , and ankle tape ) . A forceplate was used to collect ground reaction force data under the dominant foot . The first and second peak impact
Output:
| Overall results suggest that l and ing biomechanics are altered with some brace types but studies disagree as to the particular variables affected .
There is evidence that ankle bracing may alter lower-extremity l and ing biomechanics in a manner which predisposes athletes to injury . |
MS212193 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: OBJECTIVES To inform the debate over whether human sleep can be chronically reduced without consequences , we conducted a dose-response chronic sleep restriction experiment in which waking neurobehavioral and sleep physiological functions were monitored and compared to those for total sleep deprivation . DESIGN The chronic sleep restriction experiment involved r and omization to one of three sleep doses ( 4 h , 6 h , or 8 h time in bed per night ) , which were maintained for 14 consecutive days . The total sleep deprivation experiment involved 3 nights without sleep ( 0 h time in bed ) . Each study also involved 3 baseline ( pre-deprivation ) days and 3 recovery days . SETTING Both experiments were conducted under st and ardized laboratory conditions with continuous behavioral , physiological and medical monitoring . PARTICIPANTS A total of n = 48 healthy adults ( ages 21 - 38 ) participated in the experiments . INTERVENTIONS Noctumal sleep periods were restricted to 8 h , 6 h or 4 h per day for 14 days , or to 0 h for 3 days . All other sleep was prohibited . RESULTS Chronic restriction of sleep periods to 4 h or 6 h per night over 14 consecutive days result ed in significant cumulative , dose-dependent deficits in cognitive performance on all tasks . Subjective sleepiness ratings showed an acute response to sleep restriction but only small further increases on subsequent days , and did not significantly differentiate the 6 h and 4 h conditions . Polysomnographic variables and delta power in the non-REM sleep EEG-a putative marker of sleep homeostasis -- displayed an acute response to sleep restriction with negligible further changes across the 14 restricted nights . Comparison of chronic sleep restriction to total sleep deprivation showed that the latter result ed in disproportionately large waking neurobehavioral and sleep delta power responses relative to how much sleep was lost . A statistical model revealed that , regardless of the mode of sleep deprivation , lapses in behavioral alertness were near-linearly related to the cumulative duration of wakefulness in excess of 15.84 h ( s.e . 0.73 h ) . CONCLUSIONS Since chronic restriction of sleep to 6 h or less per night produced cognitive performance deficits equivalent to up to 2 nights of total sleep deprivation , it appears that even relatively moderate sleep restriction can seriously impair waking neurobehavioral functions in healthy adults . Sleepiness ratings suggest that subjects were largely unaware of these increasing cognitive deficits , which may explain why the impact of chronic sleep restriction on waking cognitive functions is often assumed to be benign . Physiological sleep responses to chronic restriction did not mirror waking neurobehavioral responses , but cumulative wakefulness in excess of a 15.84 h predicted performance lapses across all four experimental conditions . This suggests that sleep debt is perhaps best understood as result ing in additional wakefulness that has a neurobiological " cost " which accumulates over time In the GRADE approach , r and omized trials start as high- quality evidence and observational studies as low- quality evidence , but both can be rated down if most of the relevant evidence comes from studies that suffer from a high risk of bias . Well-established limitations of r and omized trials include failure to conceal allocation , failure to blind , loss to follow-up , and failure to appropriately consider the intention-to-treat principle . More recently recognized limitations include stopping early for apparent benefit and selective reporting of outcomes according to the results . Key limitations of observational studies include use of inappropriate controls and failure to adequately adjust for prognostic imbalance . Risk of bias may vary across outcomes ( e.g. , loss to follow-up may be far less for all-cause mortality than for quality of life ) , a consideration that many systematic review s ignore . In deciding whether to rate down for risk of bias -- whether for r and omized trials or observational studies -- authors should not take an approach that averages across studies . Rather , for any individual outcome , when there are some studies with a high risk , and some with a low risk of bias , they should consider including only the studies with a lower risk of bias A telephone survey was conducted of a r and om sample of New York State licensed drivers to determine the prevalence and circumstances of drowsy driving . Based on the survey responses , 54.6 % of the drivers had driven while drowsy within the past year ; 22.6 % had ever fallen asleep at the wheel without having a crash , 2.8 % had ever crashed when they fell asleep , and 1.9 % had crashed when driving while drowsy . Of the reported crashes due to driving while drowsy or falling asleep at the wheel , 82.5 % involved the driver alone in the vehicle , 60.0 % occurred between 11:00 p.m. and 7:00 a.m. 47.5 % were drive-off-road crashes , and 40.0 % occurred on a highway or expressway . Multiple regression analysis suggested that the following driver variables are predictive of an increased frequency of driving drowsy : demographic characteristics ( younger drivers , more education , and men ) ; sleep patterns ( fewer hours of sleep at night and greater frequency of trouble staying awake during the day ) ; work patterns ( greater frequency of driving for job and working rotating shifts ) ; and driving patterns ( greater number of miles driven annually and fewer number of hours a person can drive before becoming drowsy ) In the GRADE approach , r and omized trials start as high- quality evidence and observational studies as low- quality evidence , but both can be rated down if a body of evidence is associated with a high risk of publication bias . Even when individual studies included in best- evidence summaries have a low risk of bias , publication bias can result in substantial overestimates of effect . Authors should suspect publication bias when available evidence comes from a number of small studies , most of which have been commercially funded . A number of approaches based on examination of the pattern of data are available to help assess publication bias . The most popular of these is the funnel plot ; all , however , have substantial limitations . Publication bias is likely frequent , and caution in the face of early results , particularly with small sample size and number of events , is warranted During long and monotonous driving at night , most drivers progressively show signs of visual fatigue and loss of vigilance . Their capacity to maintain adequate driving performance usually is affected and varies with the age of the driver . The main question is to know , on one h and , if occurrence of fatigue and drowsiness is accompanied by a modification in the driving performance of the driver and , on the other h and , if this relationship partially depends on the driver 's age . Forty-six male drivers , divided into three age categories : 20 - 30 , 40 - 50 , and 60 - 70 years , performed a 350-km motorway driving session at night on a driving simulator . Driving errors were measured in terms of number of running-off-the-road incidents ( RORI ) and large speed deviations . The evolution of physiological vigilance level was evaluated using electroencephalography ( EEG ) recording . In older drivers , in comparison with young and middle-aged drivers , the degradation of driving performance was correlated to the evolution of lower frequency waking EEG ( i.e. , theta ) . Contrary to young and middle-aged drivers , the deterioration of the vigilance level attested by EEG correlated with the increase in gravity of all studied driving errors in older drivers . Thus , depending on the age category considered , only part of the driving errors would constitute a relevant indication as for the occurrence of a state of low arousal We ran a r and omized cross-over design study under sleep-deprived and non-sleep-deprived driving conditions to test the effects of sleep restriction on real driving performance . The study was performed in a sleep laboratory and on an open French highway . Twenty-two healthy male subjects ( age = 21.5 + /- 2 years ; distance driven per year = 12,225 + /- 4739 km ( 7641 + /- 2962 miles ) [ mean + /- S.D. ] ) drove 1000 km ( 625 miles ) over 10 h during five 105 min sessions on an open highway . Self-rated fatigue and sleepiness before each session , number of inappropriate line crossings from video recordings and simple reaction time ( RT ) were measured . Total crossings increased after sleep restriction ( 535 crossings in the sleep-restricted condition versus 66 after non-restricted sleep ( incidence rate ratio ( IRR ) : 8.1 ; 95 % confidence interval ( 95 % CI ) : 3.2 - 20.5 ; p < 0.001 ) ) , from the first driving session . The interaction between the two factors ( conditionxtime of day ) was also significant ( F(5 , 105 ) = 3.229 ; p < 0.05 ) . Increasing sleepiness score was associated with increasing crossings during the next driving session in the sleep-restricted ( IRR : 1.9 ; 95 % CI : 1.4 - 2.4 ) but not in the non-restricted condition ( IRR : 1.0 ; 95 % CI : 0.8 - 1.3 ) . Increasing self-perceived fatigue was not associated with increasing crossings in either condition ( IRR : 0.95 ; 95 % CI : 0.93 - 0.98 and IRR : 1.0 ; 95 % CI : 0.98 - 1.02 ) . Rested subjects drove 1000 km with four shorts breaks with only a minor performance decrease . Sleep restriction induced important performance degradation even though time awake ( 8h ) and session driving times ( 105 min ) were relatively short . Major inter-individual differences were observed under sleep restriction . Performance degradation was associated with sleepiness and not fatigue . Sleepiness combined with fatigue significantly affected RT . Road safety campaigns should encourage drivers to avoid driving after sleep restriction , even on relatively short trips especially if they feel sleepy A novel task , combining simulated driving with subtraction , was compared in 26 participants ages 18 to 26 years ( M = 20.6 , SD = 2.3 ; 13 men ) . After two nights of 8.5 hr . in bed , participants performed a 30-min . driving and subtraction task followed by a 10-min . Psychomotor Vigilance Task . These tasks were repeated after two more nights of 8.5 hr . time in bed for the control group and 5 hours and 3 hours time in bed for the restricted group . The sensitivity of the task to moderate sleep loss was supported because impairment was seen on several dual-task variables whereas impairment was not observed on the Psychomotor Vigilance Task This article introduces the approach of GRADE to rating quality of evidence . GRADE specifies four categories-high , moderate , low , and very low-that are applied to a body of evidence , not to individual studies . In the context of a systematic review , quality reflects our confidence that the estimates of the effect are correct . In the context of recommendations , quality reflects our confidence that the effect estimates are adequate to support a particular recommendation . R and omized trials begin as high- quality evidence , observational studies as low quality . " Quality " as used in GRADE means more than risk of bias and so may also be compromised by imprecision , inconsistency , indirectness of study results , and publication bias . In addition , several factors can increase our confidence in an estimate of effect . GRADE provides a systematic approach for considering and reporting each of these factors . GRADE separates the process of assessing quality of evidence from the process of making recommendations . Judgments about the strength of a recommendation depend on more than just the quality of evidence In industrialized countries one-fifth of all traffic accidents can be ascribed to sleepiness behind the wheel . Driver sleepiness can have many causes , including the use of medicinal drugs or prolonged driving . The present study compared the effects of prolonged highway driving at night with driving impairment caused by alcohol . A cross-over balanced design tested 14 healthy young men who drove three sessions during night-time on the open road . The driving sessions were of 2 , 4 and 8 h ( 03:00 - 05:00 , 01:00 - 05:00 and 21:00 - 05:00 hours ) duration . St and ard deviation of lateral position ( SDLP , cm ) , measuring the weaving of the car in the last driving hour of each session , was the primary parameter . Only 2 h of continuous nocturnal driving were sufficient to produce driving impairment comparable to a blood alcohol concentration ( BAC ) of 0.05 % ; after 3 h of driving impairment corresponds to a BAC of 0.08 % . In conclusion , a maximum of two continuous nocturnal driving hours should be recommended Slowed eyelid closure coupled with increased duration and frequency of closure is associated with drowsiness . This study assessed the utility of two devices for automated measurement of slow eyelid closure in a st and ard poor performance condition ( alcohol ) and following 12-h sleep deprivation . Twenty-two healthy participants ( mean age=20.8 ( SD 1.9 ) years ) with no history of sleep disorders participated in the study . Participants underwent one baseline and one counterbalanced session each over two weeks ; one 24-hour period of sleep deprivation , and one daytime session during which alcohol was consumed after a normal night of sleep . Participants completed a test battery consisting of a 30-min simulated driving task , a 10-min Psychomotor Vigilance Task ( PVT ) and the Karolinska Sleepiness Scale ( KSS ) each in two baseline sessions , and in two r and omised , counterbalanced experimental sessions ; following sleep deprivation and following alcohol consumption . Eyelid closure was measured during both tasks using two automated devices ( Copilot and Optalert ™ ) . There was an increase in the proportion of time with eyelids closed and the Johns Drowsiness Score ( incorporating relative velocity of eyelid movements ) following sleep deprivation using Optalert ( p<0.05 for both ) . These measures correlated significantly with crashes , PVT lapses and subjective sleepiness ( r-values 0.46 - 0.69 , p<0.05 ) . No difference between the two sessions for PERCLOS recorded during the PVT or the driving task as measured by the Cop
Output:
| While speed-related outcomes and crash events ( also with very low- quality evidence ) both increased under chronic sleep loss , discrepant findings were reported under conditions of acute total sleep deprivation . |
MS212194 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: UNLABELLED We studied the in vitro effects of sevoflurane , isoflurane , and propofol anesthesia on platelet function . Thirty patients undergoing minor surgical procedures were divided into three groups ( n = 10 each ) . Induction of anesthesia was achieved by using 5 mg/kg thiopental i.v . , and 0.1 mg/kg vecuronium i.v . was used for muscle relaxation . Anesthesia maintenance was provided by sevoflurane in the first , isoflurane in the second , and propofol infusion in the third group with 70 % N2O in O2 . Hemoglobin , hematocrit , thrombocyte count , prothrombin time , activated partial thromboplastin time , international normalized ratio , arterial pH , von Willebr and factor , viscosity , platelet aggregation , and bleeding time were measured 1 h pre- , intra- , and postanesthesia . There was no difference among the platelet aggregation ratios of the pre- , intra- , and postoperative periods in the isoflurane group . The aggregation ratios in the sevoflurane and propofol groups were significantly reduced at intraoperative periods compared with preoperative values . Diminished aggregation values were also found 1 h postoperatively compared with the control values in the sevoflurane and propofol groups . We conclude that , in patients with a bleeding tendency during the intra- and early postoperative period , isoflurane may be preferred as a general anesthetic . IMPLICATION S In our study , using vacuum-operated tubes , we demonstrated that sevoflurane and propofol had a significant inhibitory effect on intraoperative and early postoperative platelet aggregation , whereas isoflurane had no effect . Therefore , isoflurane may be preferred as a general anesthetic in patients with a clinical ly relevant bleeding tendency SUMMARY The addition of 0.5 per cent of halothane vapour to a basic thiopentone , nitrous oxide , muscle relaxant anaesthetic technique does not increase blood loss at Caesarean section , does not affect the incidence of hypotension , and is likely to ensure unconsciousness . By permitting the administration of 50 per cent of oxygen with nitrous oxide , the condition of the newborn infant is likely to be improved . The use of 0.8 per cent of halothane vapour does not increase blood loss but is associated with a high incidence of hypotension and for this reason is not advisable Objective To determine the surgical and anaesthetic benefits and problems associated with the practice of routine exteriorisation of the uterus to facilitate repair at caesarean section Background There are no r and omized studies on neonatal outcome after spinal versus general anesthesia for cesarean delivery in preeclamptic patients with a nonreassuring fetal heart trace . This study examined both markers of neonatal hypoxia and maternal hemodynamics . Methods Seventy patients were r and omized to general ( n = 35 ) or spinal anesthesia ( n = 35 ) . The general anesthesia group received thiopentone , magnesium sulfate , and suxamethonium intravenously before intubation , followed by 50 % nitrous oxide in oxygen , 0.75–1.5 % isoflurane , and morphine after delivery . The target end-tidal partial pressure of carbon dioxide ( Pco2 ) was 30–34 mmHg . The spinal anesthesia group received 1.8 ml hyperbaric bupivacaine plus 10 & mgr;g fentanyl at the L3–L4 interspace . Heart rate and blood pressure were measured at specific time points . Hypotension was treated with ephedrine . Maternal arterial and neonatal umbilical arterial blood gas sample s were taken at delivery . Resuscitation requirements were recorded . Results In both groups , hemodynamic measures remained within acceptable limits . Spinal anesthesia patients required more ephedrine ( 13.7 vs. 2.7 mg ) . Maternal Paco2 was lower in the spinal group ( 28.9 vs. 32.4 mmHg ) . One-minute Apgar scores were lower after general anesthesia . Base deficit was greater ( 7.13 vs. 4.68 mEq/l ) and neonatal umbilical arterial pH was lower ( 7.20 vs. 7.23 ) after spinal anesthesia . Post hoc analysis showed that if maternal diastolic blood pressure on admission was greater than 110 mmHg , neonatal umbilical arterial base deficit was greater after spinal anesthesia . There was no difference in the number of patients with Apgar scores less than 7 at 1 or 5 min or umbilical arterial pH less than 7.2 or in the requirements for resuscitation . Conclusions In preeclamptic patients with a nonreassuring fetal heart trace , spinal anesthesia for cesarean delivery was associated with a greater mean neonatal umbilical arterial base deficit and a lower median umbilical arterial pH. The clinical significance remains to be established . Maternal hemodynamics were similar and acceptable with either anesthetic technique Objective To evaluate the maternal and fetal effects of three anesthetic methods used r and omly in women with severe preeclampsia who required cesarean delivery . Methods Eighty women with severe preeclampsia , who were to be delivered by cesarean , were r and omized to general ( 26 women ) , epidural ( 27 ) , or combined spinalepidural ( 27 ) anesthesia . The mean preoperative blood pressure ( BP ) was approximately 170/110 mmHg , and all women had proteinuria . Anesthetic and obstetric management included antihypertensive drug therapy and limited intravenous ( IV ) fluid and drug therapy . Results The mean gestational age at delivery was 34.8 weeks . All infants were born in good condition as assessed by Apgar scores and umbilical arterial blood gas determinations . Maternal hypotension result ing from regional anesthesia was managed without excessive IV fluid administration . Similarly , maternal BP was managed without severe hypertensive effects in women undergoing general anesthesia . There were no serious maternal or fetal complications attributable to any of the three anesthetic methods . Conclusion General as well as regional anesthetic methods are equally acceptable for cesarean delivery in pregnancies complicated by severe preeclampsia if steps are taken to ensure a careful approach to either method There are few consistent guidelines in choosing anesthesia for cesarean section for a parturient with placenta previa . This prospect i ve r and omized trial was organized to compare the maternal hemodynamics , blood loss and neonatal outcome of general versus epidural anesthesia for cesarean section with the diagnosis of grade 4 placenta previa . After giving informed consent , 12 patients received general anesthesia and 13 received epidural . Intraoperative blood pressures demonstrated a more stable course in the epidural group than in the general group . Blood loss did not differ significantly between the groups ( 1622 + /- 775 mL vs. 1418 + /- 996 mL ) . General anesthesia result ed in lower immediate postoperative hematocrit level ( 28.1 + /- 3.5 % vs. 32.5 + /- 5.0 % , P < 0.05 ) . The patients in the general group received a significantly larger transfusion than the epidural group ( 1.08 + /- 1.6 vs. 0.38 + /- 0.9 units , P < 0.05 ) . The Apgar scores at 1 and 5 min were similar in the two groups ( 8 [ 4 - 9 ] vs. 8 [ 7 - 9 ] and 10 [ 6 - 10 ] vs. 9 [ 9 - 10 ] , respectively ) . We concluded that epidural anesthesia is superior to general anesthesia in elective cesarean section for grade 4 placenta previa with regard to maternal hemodynamics and blood loss . There was no difference in neonatal outcome BACKGROUND The risks associated with allogeneic blood transfusion are increasingly recognized . More blood is cross-matched for moderate blood loss surgery than any other indication . The role of acute normovolemic hemodilution ( ANH ) as a blood transfusion strategy was evaluated in a prospect i ve r and omized controlled trial . STUDY DESIGN AND METHODS A total of 155 patients undergoing elective hip surgery were r and omly assigned to either " ANH " ( n = 78 ) or " st and ard transfusion " ( n = 77 ) . ANH on induction of anesthesia was to a target hemoglobin ( Hb ) level of 110 g per L with return of autologous blood on wound closure . Allogeneic blood was prescribed by an objective transfusion trigger based on an Hb level of less than 80 g per L. Transfusion requirements and postoperative complications were recorded . RESULTS Allogeneic transfusion was necessary in 22 ( 29 % ) st and ard transfusion patients and 15 ( 19 % ) ANH ( odds ratio [ OR ] , 0.6 ; 95 % CI , 0.28 - 1.3 ; p = 0.23 ) with 63 and 33 units transfused , respectively ( p = 0.1 ) . Significant postoperative complications occurred in 30 ( 38 % ) st and ard transfusion patients compared with 14 ( 18 % ) of those r and omly assigned to ANH ( OR , 0.3 ; 95 % CI , 0.14 - 0.65 ; p = 0.009 ) . The major difference between the groups was the frequency of infective complications . CONCLUSION Despite modest allogeneic transfusion requirements in hip surgery , ANH reduced postoperative complications OBJECTIVE A prospect i ve r and omized trial was organized to compare the effectiveness of general and regional anesthesia for cesarean section ( C/S ) . METHOD Three hundred and forty-one patients were r and omized into the general anesthesia group ( GA ) , epidural anesthesia group ( EA ) and spinal anesthesia group ( SA ) . The effectiveness of interest was success rate , blood loss and patient satisfaction . RESULT We found that the success rates of EA and SA were lower than GA . Success in EA should be improved by using an epidural catheter to add more local anesthetic drug instead of a single shot ; and the surgeon should allow more time for the block to work adequately . Success in SA should be improved by using bupivacaine instead of lidocaine . GA result ed in significantly more blood loss , lower postoperative hematocrit , and higher proportion of patients who had postoperative hematocrit < 30 per cent than EA and SA . The patients ' satisfaction scores were not different among the 3 techniques . This meant that , given adequate explanation and perioperative care , Thai women were satisfied with regional anesthesia . CONCLUSION Regional anesthesia is a better choice of anesthesia for C/S than general anesthesia . However , the availability of different techniques and ability to change the technique when needed were very useful and important . If GA is chosen , all safety procedures must be followed . Oxygen supplement and endotracheal intubation facilities must be available in all techniques . Guidelines of anesthesia for C/S at a national level should be agreed upon , including the type of personnel , monitoring equipment and postoperative care Summary : A prospect i ve study was conducted to compare the accuracy of visual estimation of blood loss ( EBL ) at delivery with laboratory determination of measured blood loss ( MBL ) . It showed that EBL tends to be clouded by the conventional teaching that blood loss at delivery is usually between 200 to 300 mL. Women with MBL up to 150 mL were overestimated and the best correlation was in women with MBL between 150 to 300 mL. There was a tendency to underestimate blood loss when the MBL was between 301 to 500 mL. Of the 9 women with a primary postpartum haemorrhage , only one was correctly diagnosed as such and 3 women were estimated to have blood losses of at least 500 mL but the measured blood losses were all lower . It was concluded that visual estimation of blood loss is inaccurate , especially at the extremes of MBL and that primary postpartum haemorrhage is not detected by visual estimation of blood loss , unless there are associated signs of haemodynamic instability
Output:
| Based on RCTs , there was no significantly increased risk of blood transfusions with general anaesthesia .
The incidence of hypotension and the amount of fluid given were higher in the neuraxial anaesthesia groups .
General anaesthesia is associated with a higher blood loss than neuraxial anaesthesia .
However , based on high- quality studies , the need for blood transfusion was not greater .
The higher blood loss with general anaesthesia is therefore of uncertain clinical relevance |
MS212195 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: The risk factors for complications in patients with influenza A (H1N1)v virus infection have not been fully eluci date d. We performed an observational analysis of a prospect i ve cohort of hospitalized adults with confirmed p and emic influenza A (H1N1)v virus infection at 13 hospitals in Spain , between June 12 and November 10 , 2009 , to identify factors associated with severe disease . Severe disease was defined as the composite outcome of intensive-care unit ( ICU ) admission or in-hospital mortality . During the study period , 585 adult patients ( median age 40 years ) required hospitalization because of p and emic ( H1N1 ) 2009 . At least one comorbid condition was present in 318 ( 54.4 % ) patients . Pneumonia was diagnosed in 234 ( 43.2 % ) patients and bacterial co-infection in 45 ( 7.6 % ) . Severe disease occurred in 75 ( 12.8 % ) patients , of whom 71 required ICU admission and 13 ( 2.2 % ) died . Independent factors for severe disease were age < 50 years ( OR , 2.39 ; 95 % CI , 1.05 - 5.47 ) , chronic comorbid conditions ( OR , 2.93 ; 95 % CI , 1.41 - 6.09 ) , morbid obesity ( OR , 6.7 ; 95 % CI , 2.25 - 20.19 ) , concomitant and secondary bacterial co-infection ( OR , 2.78 ; 95 % CI , 1.11 - 7 ) and early oseltamivir therapy ( OR , 0.32 ; 95 % CI 0.16 - 0.63 ) . In conclusion , although adults hospitalized for p and emic ( H1N1 ) 2009 suffer from significant morbidity , mortality is lower than that reported in the earliest studies . Younger age , chronic comorbid conditions , morbid obesity and bacterial co-infection are independent risk factors for severe disease , whereas early oseltamivir therapy is a protective factor OBJECTIVE To compare the effectiveness of zanamivir with oseltamivir for influenza A and B. METHODS 1113 patients with influenza A or B were enrolled in the 2006 - 2007 influenza season . The duration of fever ( temperature , > or=37.5 degrees C ) and the percentage of patients afebrile at 24 and 48 h after the first dose of zanamivir or oseltamivir were calculated . Virus persistence after zanamivir therapy was also evaluated . RESULTS There were marginally significant differences between the duration of fever after the first dose of zanamivir ( 31.8+/-18.4h ) and oseltamivir ( 35.5+/-23.9h ) for influenza A ( p<0.05 ) . The duration of fever after starting zanamivir therapy ( 35.8+/-22.4h ) was significantly shorter than that of oseltamivir ( 52.7+/-31.3h ) for influenza B ( p<0.001 ) . There were no significant differences between influenza A and B in the percentage of patients afebrile at 24 or 48 h after the first inhalation of zanamivir . The reisolation rate after zanamivir therapy showed marginally significant differences between influenza A and B ( < 0.05 ) . By multiple regression analysis , therapy ( zanamivir or oseltamivir ) was the major determinant affecting the duration of fever for influenza B. CONCLUSION Zanamivir therapy is more effective than oseltamivir for the treatment of influenza B infection Background —Influenza infection has been associated with increased risk of adverse cardiac and cerebral vascular outcomes . Oseltamivir , a treatment for influenza , has been shown to decrease the severity of an influenza episode , but few data exist regarding its potentially protective effect against recurrent vascular outcomes among influenza patients with a history of vascular disease . Methods and Results —Electronic healthcare service and pharmacy records for 37 482 TRICARE beneficiaries , aged 18 and older , with a coded history of cardiovascular ( CV ) disease and a subsequent diagnosis of influenza from October 1 , 2003 , through September 30 , 2007 , were examined . Subjects were grouped according to whether they had filled a prescription for oseltamivir within 2 days of their influenza diagnosis . The incidence of recurrent CV events within 30 days after the influenza diagnosis among oseltavmivir-treated and untreated subjects was 8.5 % and 21.2 % , respectively ( P<0.005 ) . Subject age was a persistent and significant contributor to the likelihood of recurrent CV outcomes . After controlling for the differences in demographics among treated and untreated cohorts using a propensity-scored logistic regression model , a statistically significant protective effect was associated with oseltamivir treatment ( odds ratio , 0.417 ; 95 % CI , 0.349 to 0.498 ) . Conclusions —Our findings suggests that oseltamivir treatment for influenza is associated with significant decrease in the risk of recurrent CV events in subjects with a history of CV disease . These findings merit confirmation in further prospect i ve and controlled studies . Meanwhile , in patients with CV disease , strict adherence with current practice guidelines for prevention and treatment of influenza is recommended BACKGROUND In April 2009 a novel influenza A virus ( AH1N1v ) of swine origin ( swine flu ) emerged , spreading rapidly and achieving p and emic status in June 2009 . Pregnant women were identified as being at high risk of severe influenza-related complications and as a priority group for vaccination against AH1N1v . Limited information was available about the maternal and fetal risks of AH1N1v infection or of antiviral drug or AH1N1v vaccine use in pregnancy . OBJECTIVES To assess rates of and risk factors for adverse outcomes following AH1N1v infection in pregnancy and to assess the adverse effects of the antiviral drugs and vaccines used in prevention and management . METHODS Prospect i ve national cohort studies were conducted to identify pregnant women who were ( 1 ) suspected to be infected with AH1N1v or being treated with antiviral medication in primary care ; ( 2 ) vaccinated against AH1N1v ; and ( 3 ) admitted to hospital with confirmed AH1N1v . Characteristics of women with influenza-like illness ( ILI ) in primary care were compared with those of women without symptoms accepting or declining immunisation . Characteristics of women admitted to hospital with confirmed AH1N1v infection in pregnancy were compared with a historical cohort of over 1200 women giving birth in the UK who were uninfected with AH1N1v . Outcomes examined in hospitalised women included maternal death , admission to an intensive care unit , perinatal mortality and preterm birth . Risk factors for hospital and intensive care unit admission were examined in a full regression model . RESULTS The weekly incidence of ILI among pregnant women averaged 51/100,000 over the study period . Antiviral drugs were offered to 4.8 % [ 95 % confidence interval ( CI ) 4.0 % to 5.9 % ] and vaccination to 64.8 % ( 95 % CI 64.7 % to 68.9 % ) of registered pregnant women . Ninety pregnant women with ILI presenting in primary care were reported to the research team , 55 of whom were prescribed antiviral drugs and in 42 ( 76 % ) cases this was within 2 days of symptom onset . After comparison with 1329 uninfected pregnant women offered vaccination , pre-existing asthma was the only maternal factor identified as increasing risk of ILI presentation [ adjusted odds ratio ( OR ) 2.0 , 95 % CI 1.0 to 3.9 ] . Maternal obesity and smoking during pregnancy were also associated with hospital admission with AH1N1v infection . Overall , 241 pregnant women were admitted to hospital with laboratory-confirmed AH1N1v infection . Eighty-three per cent of these women were treated with antiviral agents , but only 6 % received antiviral treatment before hospital admission . Treatment within 2 days of symptom onset was associated with an 84 % reduction in the odds of admission to an intensive therapy unit ( OR 0.16 , 95 % CI 0.08 to 0.34 ) . Women admitted to hospital with AH1N1v infection were more likely to deliver preterm ; a three times increased risk was suggested compared with an uninfected population cohort ( OR 3.1 , 95 % CI 2.1 to 4.5 ) . CONCLUSIONS Earlier treatment with antiviral agents is associated with improved outcomes for pregnant women and further actions are needed in future p and emics to ensure that antiviral agents and vaccines are provided promptly to pregnant women , particularly in the primary care setting . Further research is needed on longer-term outcomes for infants exposed to AH1N1v influenza , antiviral drugs or vaccines during pregnancy Background The aim of this study was to investigate factors affecting clinical outcomes of adults hospitalised with severe seasonal influenza . Methods A prospect i ve , observational cohort study was conducted over 24 months ( 2007–2008 ) in two acute , general hospitals . Consecutive , hospitalised adult patients were recruited and followed once their laboratory diagnosis of influenza A/B was established ( based on viral antigen detection and virus isolation from nasopharyngeal aspirates collected per protocol ) . Outcomes studied included in-hospital death , length of stay and duration of oxygen therapy . Factors affecting outcomes were analysed using multivariate Cox proportional hazards models . Sequencing analysis on the neuraminidase gene was performed for available H1N1 isolates . Results 754 patients were studied ( influenza A , n=539 ; > 75 % H3N2 ) . Their mean age was 70±18 years ; co-morbidities and serious complications were common ( 61–77 % ) . Supplemental oxygen and ventilatory support was required in 401 ( 53.2 % ) and 41 ( 5.4 % ) patients , respectively . 39 ( 5.2 % ) patients died ; pneumonia , respiratory failure and sepsis were the causes . 395 ( 52 % ) patients received antiviral ( oseltamivir ) treatment . Omission of antiviral treatment was associated with delayed presentation or negative antigen detection results . The mortality rate was 4.56 and 7.42 per 1000 patient-days in the treated and untreated patients , respectively ; among those with co-morbidities , it was 5.62 and 11.64 per 1000 patient-days , respectively . In multivariate analysis , antiviral use was associated with reduced risk of death ( adjusted HR ( aHR ) 0.27 ( 95 % CI 0.13 to 0.55 ) ; p<0.001 ) . Improved survival was observed with treatment started within 4 days from onset . Earlier hospital discharge ( aHR 1.28 ( 95 % CI 1.04 to 1.57 ) ; p=0.019 ) and faster discontinuation of oxygen therapy ( aHR 1.30 ( 95 % CI 1.01 to 1.69 ) ; p=0.043 ) was associated with early treatment within 2 days . Few ( n=15 ) H1N1 isolates in this cohort had the H275Y mutation . Conclusions Antiviral treatment for severe influenza is associated with reduced mortality and improved clinical outcomes Oseltamivir has been used for treatment of influenza A and B infections , but recent reports documented that it was less active against the latter . We compared the effectiveness of oseltamivir in children between laboratory confirmed influenza A and B over 4 influenza seasons from 2001 to 2005 in a pediatric clinic in Japan . Among 1,848 patients screened , 299 influenza A and 209 influenza B patients were administered oseltamivir ( treated groups ) , and 28 influenza A and 66 influenza B patients were assigned as non-treated groups . The duration of fever , defined as period when patients had the maximum temperature higher than 37.5 degrees C in three-time measurements in a day after the clinic visit , was evaluated among the four groups . In uni-variate analysis , the duration of fever was shorter for treated group than non-treated for influenza A ( 1.8 + /- 0.9 days vs 2.6 + /- 1.3 days , p < 0.01 ) , but it was not significant for influenza B ( 2.4 + /- 1.3 days vs 2.8 + /- 1.2 days , p = 0.9 ) . The fever duration was longer in treated influenza B than A patients ( p < 0.01 ) . Multi-variate analysis indicated younger age ( < 6 years old ) and higher body temperature at the clinic visit prolonged the duration of fever . Adjusted average duration of fever indicated that oseltamivir was effective for both types , but more effective on influenza A , and the benefit increased for younger children . Our data provide evidence that oseltamivir is beneficial for influenza infections , but the effectiveness is differed by type and age BACKGROUND To compare the effectiveness of oseltamivir for treatment of influenza
Output:
| Earlier treatment with oseltamivir was generally associated with better outcomes .
Direct comparison of oral oseltamivir and inhaled zanamivir suggests no important differences in key outcomes .
Therapy with oral oseltamivir and inhaled zanamivir may provide a net benefit over no treatment of influenza . |
MS212196 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: People with diabetes are more likely to be hospitalized and to have longer duration s of hospital stay than those without diabetes . A recent survey estimated that 22 % of all hospital inpatient days were incurred by people with diabetes and that hospital inpatient care accounted for half of the 174 billion USD total U.S. medical expenditures for this disease ( 1 ) . These findings are due , in part , to the continued expansion of the worldwide epidemic of type 2 diabetes . In the U.S. alone , there are ∼1.6 million new cases of diabetes each year , with an over all prevalence of 23.6 million people ( 7.8 % of the population , with one-fourth of the cases remaining undiagnosed ) . An additional 57 million American adults are at high risk for type 2 diabetes ( 2 ) . Although the costs of illness-related stress hyperglycemia are not known , they are likely to be considerable in light of the poor prognosis of such patients ( 3–6 ) . There is substantial observational evidence linking hyperglycemia in hospitalized patients ( with or without diabetes ) to poor outcomes . Cohort studies as well as a few early r and omized controlled trials ( RCTs ) have suggested that intensive treatment of hyperglycemia improved hospital outcomes ( 5–8 ) . In 2004 , this evidence led the American College of Endocrinology ( ACE ) and the American Association of Clinical Endocrinologists ( AACE ) , in collaboration with the American Diabetes Association ( ADA ) and other medical organizations , to develop recommendations for treatment of inpatient hyperglycemia ( 9 ) . In 2005 , the ADA added recommendations for treatment of hyperglycemia in the hospitalto itsannual St and ards of Medical Care ( 10 ) . Recommendations from the ACE and the ADA generally endorsed tight glycemic control in critical care units . For patients in general medical and surgical units , where RCT evidence regarding treatment targets was lacking , glycemic goals similar to those advised for out patients were advocated ( 9 , Type 2 diabetes is associated with altered immune and hemostatic responses . We investigated the selective effects of hyperglycemia and hyperinsulinemia on innate immune , coagulation , and fibrinolytic responses during systemic inflammation . Twenty-four healthy humans were studied for 8 hours during clamp experiments in which either plasma glucose , insulin , both , or none was increased , depending on r and omization . Target plasma concentrations were 5 versus 12 mM for glucose , and 100 versus 400 pmol/L for insulin . After 3 hours , 4 ng/kg Escherichia coli endotoxin was injected intravenously to induce a systemic inflammatory and procoagulant response . Endotoxin administration induced cytokine release , activation of neutrophils , endothelium and coagulation , and inhibition of fibrinolysis . Hyperglycemia reduced neutrophil degranulation ( plasma elastase levels , P < .001 ) and exaggerated coagulation ( plasma concentrations of thrombin-antithrombin complexes and soluble tissue factor , both P < .001 ) . Hyperinsulinemia attenuated fibrinolytic activity due to elevated plasminogen activator-inhibitor-1 levels ( P < .001 ) . Endothelial cell activation markers and cytokine concentrations did not differ between clamps . We conclude that in humans with systemic inflammation induced by intravenous endotoxin administration hyperglycemia impairs neutrophil degranulation and potentiates coagulation , whereas hyperinsulinemia inhibits fibrinolysis . These data suggest that type 2 diabetes patients may be especially vulnerable to prothrombotic events during inflammatory states BACKGROUND Glycemic control is important to patients ' outcomes . However , the process of maintaining glycemic control is risk laden and labor intensive for nurses . OBJECTIVES To examine the effects of using a computerized insulin dose calculator to facilitate management of glycemic control for critically ill cardiac patients . METHODS A prospect i ve r and omized controlled trial was conducted with a sample of 300 intensive care patients , 141 r and omized to the calculator group and 159 in the control ( paper protocol ) group . A convenience sample of 44 intensive care nurses responded to a nurse satisfaction survey . RESULTS A significantly higher percentage of glucose measurements were in the target range in the calculator group than in the control group ( 70.4 % [ SD , 15.2 % ] vs 61.6 % [ SD , 17.9 % ] , Z = -4.423 , P < .001 ) , and glucose variance was significantly less in the calculator group ( 35.5 [ SD , 18.3 ] mg/dL vs 42.3 [ SD , 21.2 ] mg/dL , Z = -3.845 , P < .001 ) . Fewer hypoglycemic events occurred in the calculator group ( 7 vs 18 ) , although this difference was not statistically significant . Nurse satisfaction was higher for the calculator group than for the control group ( 8.4 [ SD , 1.4 ] vs 4.8 [ SD , 2.4 ] , Z = -5.055 , P < .001 ) . Nurses ' deviation from the protocol was also less in the calculator group than in the control group . CONCLUSIONS Management of glycemic control and nurse satisfaction were improved with use of the dose calculator . Improving nurses ' processes of care may improve nurses ' use of time and patient care overall . Studies with larger sample sizes over time are needed to determine these relationships BACKGROUND Intensive glycemic control has been associated with reduced morbidity and mortality in critically ill patients . Web-based , patient-specific insulin nomograms may facilitate improved glucose control . OBJECTIVE To compare 2 algorithms for individualizing insulin infusion therapy ( a web-based system [ Glucomm and er method ] and a st and ard paper-based nomogram ) in a cardiovascular surgery intensive care unit ( ICU ) . METHODS In this prospect i ve , before-after cohort study , measures of glycemic control for 50 patients receiving insulin according to the Glucomm and er system were compared with a control group ( n = 50 ) who received insulin according to the st and ard paper-based nomogram used in the cardiovascular surgery ICU . RESULTS There was no significant difference between the 2 groups with respect to time to target blood glucose ( 5.1 - 8.0 mmol/L ) , percentage of time within the target range , or mean amplitude of glucose excursion . Patients in the intervention group spent less time above the target range ( p = 0.007 ) and more time below the target range ( p < 0.001 ) , and the mean glucose was lower in this group compared with the control group ( 7.9 versus 8.6 mmol/L , p = 0.002 ) . The percentage of blood glucose measurements below 4 mmol/L was higher in the intervention group than in the control group ( 3.7 % versus 1.4 % , p = 0.003 ) . Satisfaction surveys revealed that the program was well accepted by the nursing staff in the cardiovascular surgery ICU . CONCLUSIONS A web-based insulin nomogram was an easy-to-use instrument for achieving tighter glucose control for patients in the cardiovascular surgery ICU . Use of the Glucomm and er system led to lower mean blood glucose but an increase in episodes of hypoglycemia BACKGROUND : In the setting of protocol ized glycemic control , the relationship between postoperative glycemic variability on major adverse events ( MAEs ) after cardiac surgery is unknown for patients with increased preoperative hemoglobin A1C ( HbA1C > 6.5 % ) . In this study , we sought to establish ( a ) whether postoperative glycemic variability is associated with MAEs after CABG surgery and ( b ) whether preoperative HbA1C could identify patients at increased risk of postoperative glycemic variability . METHODS : Patients undergoing coronary artery bypass grafting with or without valvular surgery from January 2008 to May 2011 were enrolled in this prospect i ve , single-center , observational cohort study . Demographic , intraoperative , and postoperative outcome data were obtained from institutional data collected for the Society of Thoracic Surgery ( STS ) data base . The primary outcome , MAE was a composite of in-hospital death , myocardial infa rct ion ( MI ) , reoperations , sternal infection , cardiac tamponade , pneumonia , stroke , or renal failure . Glycemic variability in the postoperative period was assessed by the coefficient of variation ( CV ) . CV was used as quartiles for the multivariate logistic regression . Variable selection in multivariable modeling was based on clinical and statistical significance and was performed in a hierarchical fashion . RESULTS : Of the 1461 patients enrolled , 9.8 % had an MAE . Based on the established target of HbA1C < 6.5 % for the diagnosis of diabetes mellitus , we considered HbA1C as a binary variable ( < 6.5 % and ≥6.5 % ) in our primary analysis . Multivariate logistic regression analyses for the preoperative variables only revealed that preoperative HbA1C ( odds ratio [ OR ] , 1.6 ; 95 % confidence interval [ CI ] , 1.1–2.3 ; P = 0.02 ) , history of MI ( OR , 1.9 ; 95 % CI , 1.3–2.8 ; P = 0.001 ) , and STS risk score per quartile ( OR , 1.7 ; 95 % CI , 1.4–2.1 ; P < 0.001 ) were associated with MAEs . When postoperative variables were included in the analyses , postoperative glycemic variability ( CV per quartile ) in the intensive care unit ( OR , 1.3 ; 95 % CI , 1.1–1.5 ; P = 0.03 ) , mean glucose levels averaged over the first 4 postoperative hours ( OR , 1.2 ; 95 % CI , 1.0–1.4 ; P = 0.03 ) , history of MI ( OR , 1.8 ; 95 % CI , 1.2–2.6 ; P = 0.004 ) , and STS risk score per quartile ( OR , 1.6 ; 95 % CI , 1.3–2.0 ; P < 0.001 ) were associated with MAEs . Glycemic variability as assessed by CV was increased postoperatively in patients with preoperative HbA1C ≥6.5 % ( 0.20 ± 0.09 vs 0.16 ± 0.07 , P < 0.001 ) . CONCLUSIONS : Postoperative glycemic variability is associated with MAEs after cardiac surgery . Glycemic variability is only measured when the patient leaves the intensive care unit , and there is no opportunity to intervene earlier . Preoperative HbA1C identifies risk for postoperative glycemic variability and may provide a more rational guide for targeting measures to reduce variability OBJECTIVE We performed a r and omized trial to compare three insulin-titration protocol s for tight glycemic control ( TGC ) in a surgical intensive care unit : an absolute glucose ( Matias ) protocol , a relative glucose change ( Bath ) protocol , and an enhanced model predictive control ( eMPC ) algorithm . RESEARCH DESIGN AND METHODS A total of 120 consecutive patients after cardiac surgery were r and omly assigned to the three protocol s with a target glycemia range from 4.4 to 6.1 mmol/l . Intravenous insulin was administered continuously or in combination with insulin boluses ( Matias protocol ) . Blood glucose was measured in 1- to 4-h intervals as requested by the protocol s. RESULTS The eMPC algorithm gave the best performance as assessed by time to target ( 8.8 ± 2.2 vs. 10.9 ± 1.0 vs. 12.3 ± 1.9 h ; eMPC vs. Matias vs. Bath , respectively ; P < 0.05 ) , average blood glucose after reaching the target ( 5.2 ± 0.1 vs. 6.2 ± 0.1 vs. 5.8 ± 0.1 mmol/l ; P < 0.01 ) , time in target ( 62.8 ± 4.4 vs. 48.4 ± 3.28 vs. 55.5 ± 3.2 % ; P < 0.05 ) , time in hyperglycemia > 8.3 mmol/l ( 1.3 ± 1.2 vs. 12.8 ± 2.2 vs. 6.5 ± 2.0 % ; P < 0.05 ) , and sampling interval ( 2.3 ± 0.1 vs. 2.1 ± 0.1 vs. 1.8 ± 0.1 h ; P < 0.05 ) . However , time in hypoglycemia risk range ( 2.9–4.3 mmol/l ) in the eMPC group was the longest ( 22.2 ± 1.9 vs. 10.9 ± 1.5 vs. 13.1 ± 1.6 ; P < 0.05 ) . No severe hypoglycemic episode ( < 2.3 mmol/l ) occurred in the eMPC group compared with one in the Matias group and two in
Output:
| There is some evidence to support the use of computerised insulin dosing calculators for insulin infusion management within critical care environments |
MS212197 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: OBJECTIVE To evaluate the efficacy and safety of misoprostol among patients with retained placenta in a low-re source setting . METHODS A prospect i ve , multicenter , r and omized , double-blind , placebo-controlled trial was carried out in Tanzania between April 2008 and November 2011 . It included patients who delivered at a gestational age of 28 weeks or more and had blood loss of 750 mL or less at 30 minutes after delivery . Sublingual misoprostol ( 800 μg ) was compared with placebo as the primary treatment . Power analysis showed that 117 patients would be required to observe a reduction of 40 % in the incidence of manual removal of the placenta ( MRP ; P=0.05 , 80 % power ) , the primary outcome . The secondary outcomes were blood loss and number of blood transfusions . RESULTS Interim analysis after recruitment of 95 patients showed that incidence of MRP , total blood loss , and incidence of blood transfusions were similar in the misoprostol ( MRP , 40 % ; blood loss , 803 mL ; blood transfusion , 15 % ) and placebo ( MRP , 33 % , blood loss 787 mL , blood transfusion , 23 % ) groups . The trial was stopped because continuation would not alter the interim conclusion that misoprostol was ineffective . CONCLUSION Treatment with misoprostol was found to have no clinical ly significant beneficial effect among women with retained placenta . CLINICAL TRIAL REGISTRATION Current Controlled Trials IS RCT N16104753 OBJECTIVE To assess the effect of injecting an uterotonic agent in the umbilical vein during the third stage of labor in women with retained placentas . METHODS In this prospect i ve clinical study , 75 women with retained placentas received 20 mL of a 0.9 % saline solution with either 20 IU of oxytocin ( n=54 ) , 0.5 mg of carboprost tromethamine ( n=7 ) , or 0.2 mg of methylergometrine ( n=14 ) injected in the umbilical vein after clamping . The treatment success was determined by the clinical signs of placental ablation . RESULTS There were no statistically significant differences among the 3 therapeutic groups regarding age , parity , risk factors , pregnancy duration , type of delivery ( spontaneous , induced , or augmented ) , or possible early postpartum complications caused by the intraumbilical injection . The rates of therapeutic success were 76.9 % in the oxytocin group , 85.7 % in the synthetic prostagl and in group , and 64.2 % in the methylergometrine group . CONCLUSION The intraumbilical injection of uterotonics is a noninvasive , effective , and clinical ly safe method of shortening the third stage of labor in women with retained placentas OBJECTIVE The purpose of this study was to determine the extent that the administration of sulprostone reduces the need for manual removal of the placenta in patients with retained placenta . STUDY DESIGN A double-blinded sequential r and omized controlled trial of sulprostone versus placebo was conducted among 103 patients with retained placenta . RESULTS In the first phase of this sequential study , sulprostone was compared with placebo . The null hypothesis of equal effectiveness of both treatments was rejected after 50 patients . In patients with retained placenta , the placenta was expelled after sulprostone in 13 of 24 cases ( 51.8 % , bias adjusted ) , whereas expulsion after placebo was achieved in only 4 of 26 cases ( 17.6 % , bias adjusted ) . The difference was significant ( P = .034 ) . In the second phase of the study , in which the placebo arm was stopped , results were confirmed ; in 25 of 53 patients ( 47 % ) , the placenta was expelled . CONCLUSION Sulprostone reduces the need for the manual removal of the placenta by 49 % Background . Manual removal of placenta is performed in 1–3 % of cases , and whilst a well established and relatively safe procedure , it is not without complications , which include infection , hemorrhage , uterine rupture , and occasional maternal death . Methods . A three‐arm r and omized controlled trial of 50 IU Syntocinon ( in 30 ml N saline ) versus 800 mcg misoprostol ( in 30 ml N saline ) versus 30 ml N saline alone ( control ) , injected into the placental bed via the umbilical vein using the Pipingas method . A group sequential research model ( triangular test : PEST4 ) was adopted to minimize the sample size , as retained placenta is a relatively uncommon condition . Results . No significant difference in the rate of manual removal was observed between the control and Syntocinon groups . On triggering the automatic stopping rule for this arm of the trial all subsequent cases recruited were allocated to receive either Syntocinon or misoprostol . After a total of 54 cases a significant reduction in manual removal of placenta was observed in the misoprostol group , triggering the automatic stopping rule and terminating the trial . Conclusion . Misoprostol ( 800 mcg ) dissolved in 30 ml N saline and administered by intraumbilical injection using the Pipingas technique significantly reduces the need for manual removal for retained adherent placenta , whereas Syntocinon has similar effectiveness to injection of N saline alone The length of the third stage of labour is a potential modifiable risk factor for postpartum haemorrhage at vaginal delivery , but there is no definitive evidence that early intervention to remove the placenta manually will prevent postpartum haemorrhage . We report a wide variation between countries in Europe in policies about the timing of manual removal of placenta . Two groups of countries with clearly divergent policies were identified . A r and omised controlled trial is needed to provide definitive evidence on the risks and benefits of manual removal of placenta at different timings after vaginal delivery INTRODUCTION This study aim ed to determine the incidence of , and identify independent risk factors to retained placenta in Ile-Ife , southwestern Nigeria . METHODS This was a prospect i ve case-control study involving 120 women with retained placenta after vaginal birth at the Obafemi Awolowo University Teaching Hospital , Ile-Ife , southwestern Nigeria over a period of seven years . Two consecutive normal deliveries after each retained placenta served as controls . Following a bivariate analysis , a multivariate logistic regression model was constructed in order to define independent risk factors for retained placenta while controlling for confounding variables . RESULTS During the study period , there were 120 cases of retained placenta , and the total number of deliveries was 6,160 , making the incidence 1.9 percent . Independent risk factors associated with retained placenta include non-use of antenatal care ( odds-ratio [ OR ] 22.71 , 95 percent confidence interval [ CI ] 10.5 - 49.12 , p-value is less than 0.000 ) , previous retained placenta ( OR 15.22 , 95 percent CI 3.30 - 70.19 , p-value is less than 0.000 ) , previous caesarean section ( OR 12.00 , 95 percent CI 2.05 - 70.19 , p-value is less than 0.006 ) , maternal age 35 years or more ( OR 7.10 , 95 percent CI 1.5 - 32.40 , p-values is less than 0.012 ) , gr and multiparity ( OR 6.63 , 95 percent CI 1.88 - 23.40 , p-value is less than 0.003 ) , previous dilatation and curettage ( OR 4.44 , 95 percent CI 1.69 - 11.63 , p-value is less than 0.002 ) , preterm delivery ( OR 3.12 , 95 percent CI 1.12 - 8.68 , p-value is less than 0.029 ) and placenta weight less than 501 g ( OR 2.91 , 95 percent CI 1.34 - 6.32 , p-value is less than 0.007 ) . CONCLUSION Women with identifiable risk factors should be targeted for the prevention of retained placenta . There is a need for the training of birth attendants in the proper conduct of delivery and third stage of labour to prevent placenta retention and postpartum haemorrhage OBJECTIVE : To identify risk factors for immediate postpartum hemorrhage after vaginal delivery in a South American population . METHODS : This was a prospect i ve cohort study including all vaginal births ( N=11,323 ) between October and December 2003 and October and December 2005 from 24 maternity units in two South American countries ( Argentina and Uruguay ) . Blood loss was measured in all births using a calibrated receptacle . Moderate postpartum hemorrhage and severe postpartum hemorrhage were defined as blood loss of at least 500 mL and at least 1,000 mL , respectively . RESULTS : Moderate and severe postpartum hemorrhage occurred in 10.8 % and 1.9 % of deliveries , respectively . The risk factors more strongly associated and the incidence of moderate postpartum hemorrhage in women with each of these factors were : retained placenta ( 33.3 % ) ( adjusted odds ratio [ OR ] 6.02 , 95 % confidence interval [ CI ] 3.50–10.36 ) , multiple pregnancy ( 20.9 % ) ( adjusted OR 4.67 , CI 2.41–9.05 ) , macrosomia ( 18.6 % ) ( adjusted OR 2.36 , CI 1.93–2.88 ) , episiotomy ( 16.2 % ) ( adjusted OR 1.70 , CI 1.15–2.50 ) , and need for perineal suture ( 15.0 % ) ( adjusted OR 1.66 , CI 1.11–2.49 ) . Active management of the third stage of labor , multiparity , and low birth weight were found to be protective factors . Severe postpartum hemorrhage was associated with retained placenta ( 17.1 % ) ( adjusted OR 16.04 , CI 7.15–35.99 ) , multiple pregnancy ( 4.7 % ) ( adjusted OR 4.34 , CI 1.46–12.87 ) , macrosomia ( 4.9 % ) ( adjusted OR 3.48 , CI 2.27–5.36 ) , induced labor ( 3.5 % ) ( adjusted OR 2.00 , CI 1.30–3.09 ) , and need for perineal suture ( 2.5 % ) ( adjusted OR 2.50 , CI 1.87–3.36 ) . CONCLUSION : Many of the risk factors for immediate postpartum hemorrhage in this South American population are related to complications of the second and third stage of labor . LEVEL OF EVIDENCE : OBJECTIVE To determine the frequency , causes and outcome of patients with retained placenta . METHODS Descriptive case series . This study was carried out at Liaquat University Hospital , Gynae Unit-I , from January 2005 to December 2007 . Two years retrospective and one year prospect i ve analysis of patients was done according to age , parity , causes , place of delivery , person who conducted the delivery , conservative and surgical procedures , maternal morbidity and mortality . Patients were examined and appropriate investigations were done . The patients who came with or developed retained placenta at Liaquat University Hospital were included in the study . The patients having retained placenta due to uterine abnormalities were excluded from the study . All the information was collected on a pre design ed proforma and analyzed on SPSS version 10.0 . RESULTS About 8782 patients were admitted during the specified period . Ninety patients had retained placenta . Frequency of retained placenta was 37.7 % in women of age group 26 to 30 years , 26.6 % upto age of 35 years , 22.2 % in age 20 - 25 years , it was low between 36 - 40 years of age , while the frequency was high in women of low parity ( 44.4 % ) . Causes included augmentation by oxytocics in 38.8 % , manipulation 38.8 % , inertia 14.4 % and tumour ( fibroid ) 7.7 % . Majority of patients ( 60 % ) had a home delivery . Delivery by Dai was done in 72.2 % . The commonest complication was anaemia 48.8 % , followed by puerperal pyrexia 24.4 % , hypovolaemic shock 22.2 % , acute renal failure 3.3 % and hepatic failure in 1.1 % respectively . CONCLUSION Retained placenta is a frequent cause of maternal morbidity in Pakistan Background Retained placenta is one of the common causes of maternal mortality in developing countries where access to appropriate obstetrical care is limited . Current treatment of retained placenta is manual removal of the placenta under anaesthesia , which can only take place in larger health care facilities . Medical treatment of retained placenta with prostagl and ins E1 ( misoprostol ) could be cost-effective and easy-to-use and could be a life-saving option in many low-re source setting s. The aim of this study is to assess the efficacy and safety of sublingually administered misoprostol in women with retained placent
Output:
| Use of prostagl and ins result ed in less need for manual removal of placenta , severe postpartum haemorrhage and blood transfusion but none of the differences reached statistical significance .
Much larger , adequately powered studies are needed to confirm that these clinical ly important beneficial effects are not just chance findings .Similarly , no differences were detected between prostagl and ins and placebo in mean blood loss or the mean time from injection to placental removal ( minutes ) or side-effects ( vomiting , headache , pain and nausea between injection and discharge from the labour ward ) except for ' shivering ' which was more frequent in women who received prostagl and in . |
MS212198 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: HYPOTHESIS Laparoscopic anterior 90 degrees partial fundoplication for gastroesophageal reflux is associated with a lower incidence of postoperative dysphagia and other adverse effects compared with laparoscopic Nissen fundoplication . DESIGN A multicenter , prospect i ve , double-blind , r and omized controlled trial . SETTING Nine university teaching hospitals in 6 major cities in Australia and New Zeal and . PARTICIPANTS One hundred twelve patients with proven gastroesophageal reflux disease presenting for laparoscopic fundoplication were r and omized to undergo either a Nissen ( 52 patients ) or an anterior 90 degrees partial procedure ( 60 patients ) . Patients with esophageal motility disorders , patients requiring a concurrent abdominal procedure , and patients who had undergone previous antireflux surgery were excluded from this study . INTERVENTIONS Laparoscopic Nissen fundoplication with division of the short gastric vessels or laparoscopic anterior 90 degrees partial fundoplication . MAIN OUTCOME MEASURES Independent assessment of dysphagia , heartburn , and overall satisfaction 1 , 3 , and 6 months after surgery using multiple clinical grading systems . Objective measurement of esophageal manometric parameters , esophageal acid exposure , and endoscopic assessment . RESULTS Postoperative dysphagia , and wind-related adverse effects were less common after a laparoscopic anterior 90 degrees partial fundoplication . Relief of heartburn was better following laparoscopic Nissen fundoplication . Overall satisfaction was better after anterior 90 degrees partial fundoplication . Lower esophageal sphincter pressure , acid exposure , and endoscopy findings were similar for both procedures . CONCLUSIONS At the 6-month follow-up , laparoscopic anterior 90 degrees culine partial fundoplication is followed by fewer adverse effects than laparoscopic Nissen fundoplication with full fundal mobilization , and it achieves a higher rate of satisfaction with the overall outcome . However , this is offset to some extent by a greater likelihood of recurrent gastroesophageal reflux symptoms BACKGROUND Total fundoplication for gastro-oesophageal reflux disease may be followed by unwanted side-effects . A r and omized trial demonstrated that an anterior 180 degrees partial fundoplication achieved effective reflux control and was associated with fewer side-effects in the short term than total fundoplication . This paper reports longer-term ( 5 year ) outcomes from that trial . METHODS Between December 1995 and June 1997 , 107 patients were r and omized to undergo either laparoscopic total fundoplication or a laparoscopic anterior 180 degrees fundoplication . After 5 years , 101 of 103 eligible patients ( 51 total , 50 anterior ) were available for follow-up . Each patient was interviewed by a single blinded investigator and a st and ardized question naire was completed . The question naire focused on symptoms and overall satisfaction with the results of fundoplication . RESULTS There were no significant differences between the two groups with regard to control of heartburn or patient satisfaction with the overall outcome . Dysphagia , measured by a visual analogue score for solid food and a composite dysphagia score , was worse at 5 years after total fundoplication . Symptoms of bloating , inability to belch and flatulence were also more common after total fundoplication . Reoperation was required for dysphagia in three patients after total fundoplication and for recurrent reflux in three patients after anterior fundoplication . CONCLUSION Anterior 180 degrees partial fundoplication was as effective as total fundoplication for managing the symptoms of gastro-oesophageal reflux in the longer term . It was associated with a lower incidence of side-effects , although this was offset by a slightly higher risk of recurrent reflux symptoms Objective : To compare 10 years outcome of a multicenter r and omized controlled trial on laparoscopic ( LNF ) and conventional Nissen fundoplication ( CNF ) , with focus on effectiveness and reoperation rate . Summary of Background Data : LNF has replaced CNF as surgical treatment for gastroesophageal reflux disease ( GERD ) . Decisions are based on equal short-term effectiveness and reduced morbidity , but confirmation by long-term level 1 evidence is lacking . Methods : From 1997 to 1999 , 177 proton pump inhibitor (PPI)-refractory GERD patients were r and omized to undergo LNF or CNF . The 10 years results of surgery on reflux symptoms , general health , PPI use , and reoperation rates , are described . High-resolution manometry , 24-hour pH-impedance monitoring and barium swallow were performed in symptomatic patients only . Results : A total of 148 patients ( 79 LNF , 69 CNF ) participated in this 10-year follow-up study . GERD symptoms were relieved in 92.4 % and 90.7 % ( NS ) after LNF and CNF , respectively . Severity of heartburn and dysphagia were similar , but slightly more patients had relief of regurgitation after LNF ( 98.7 % vs. 91.0 % ; P = 0.030 ) . The percentage of patients using PPIs slowly increased with time in both groups to 26.6 % for LNF and 22.4 % for CNF ( NS ) . General health ( 74.7 % vs. 72.7 % ; NS ) and quality of life ( visual analogue scale score : 65.3 vs. 61.4 ; NS ) improved similarly in both groups . The percentage of patients who would have opted for surgery again was similar as well ( 78.5 % vs. 72.7 % ; NS ) . Twice as many patients underwent reoperation after CNF compared with LNF ( 12 [ 15.2 % ] vs. 24 [ 34.8 % ] ; P = 0.006 ) , including a higher number of incisional hernia corrections ( 2 vs. 9 ; P = 0.015 ) . Mean interval between operation and reintervention was longer after CNF ( 22.9 vs. 50.6 months ; P = 0.047 ) . Of the patients who were dependent on daily PPI therapy at 10 years ( LNF 10 , CNF 10 ) , 7 patients ( LNF 3 , CNF 4 ) had recurrent GERD on pH-impedance monitoring , 5 of them with some form of anatomic recurrence . A total of 13 of 20 ( 65.0 % ) patients did not have recurrent GERD . Fourteen patients had an abnormal high-resolution manometry . Conclusions : CNF carries a higher risk for surgical reintervention compared with LNF , mainly due to incisional hernia corrections . The 10-year effectiveness of LNF and CNF is comparable in terms of improvement of GERD symptoms , PPI use , quality of life , and objective reflux control . Consequently , the long-term results from this trial lend level 1 support to the use of LNF as the surgical procedure of choice for GERD BACKGROUND The effect of total ( Nissen ) and anterior partial fundoplication ( APF ) for the surgical treatment of gastroesophageal reflux disease ( GERD ) on the motor behavior of the esophagogastric axis has not been fully assessed . The purpose of this study was to assess any alterations in lower esophageal sphincter ( LES ) and gastric fundus motor parameters in GERD patients after Nissen or APF fundoplication . METHODS Twenty four patients with documented GERD underwent either laparoscopic Nissen fundoplication ( n = 12 ) or laparoscopic APF ( n = 12 ) . Preoperative and postoperative stationary esophageal manometry included assessment of LES resting and postdeglutition relaxation pressures , intragastric pressure , and LES transient relaxations in the left lateral and upright positions and after gastric distension . RESULTS Both types of fundoplication result ed in significant increases in LES resting ( P < 0.001 ) and postdeglutition relaxation pressure ( P < 0.001 ) in both positions and after gastric distention . Intragastric pressure increased only after Nissen fundoplication in the postgastric distention state ( P = 0.01 ) . Transient LES relaxations were equally abolished after both procedures . All postoperative changes were to a similar level after either procedure with the exception of intragastric pressure after gastric distention , which was significantly higher after total than after partial fundoplication ( P = 0.04 ) . CONCLUSIONS Both procedures equally increase LES resting and postdeglutition relaxation pressures and abolish transient LES relaxations at all states . The significantly higher intragastric pressure at the postgastric distention state after Nissen fundoplication could possibly explain the higher incidence of epigastric fullness and discomfort after this type of antireflux surgery In the operative management of gastro‐oesophageal reflux , a balance must be achieved between adequate control of reflux and excessive dysphagia . The ideal technique is not known . A r and omized study was performed to determine whether laparoscopic anterior fundoplication is associated with a lower incidence of postoperative dysphagia than laparoscopic Nissen fundoplication , while achieving equivalent control of reflux BACKGROUND AND AIMS The purpose of this study was to determine whether esophageal dysmotility affects symptoms of gastroesophageal reflux disease or clinical outcome after laparoscopic fundoplication and whether esophagus motor function changes postoperatively . METHODS Two hundred patients with a history of long-st and ing gastroesophageal reflux disease were investigated by clinical assessment , upper gastrointestinal endoscopy , esophageal manometry , and 24-hour pH monitoring between May 1999 and May 2000 . Patients were stratified according to presence or absence of esophageal dysmotility ( each n = 100 ) and r and omized to either 360 degrees ( Nissen ) or 270 degrees ( Toupet ) fundoplication . At a 4-month postoperative follow-up , preoperative tests were repeated . RESULTS Preoperative esophageal dysmotility was associated with more severe reflux symptoms , more frequent resistance to medical treatment ( 64 % vs. 49 % ; P < 0.05 ) , and greater decrease in lower esophageal sphincter pressure ( 9.5 + /- 5.3 vs. 12.4 + /- 6.7 mm Hg ; P < 0.0005 ) compared with normal motility . Postoperatively , clinical outcome and reflux recurrence ( 21 % vs. 14 % ) were similar . Esophageal motility remained unchanged in 85 % of patients and changed from pathologic to normal in 20 ( 10 Nissen/10 Toupet ) and vice versa in 9 ( 8 Nissen/1 Toupet ) patients . CONCLUSIONS Esophageal dysmotility ( 1 ) reflects more severe disease ; ( 2 ) does not affect postoperative clinical outcome ; ( 3 ) is not corrected by fundoplication , independent of the surgical procedure performed ; ( 4 ) may occur as a result of fundoplication ; and ( 5 ) requires no tailoring of surgical management Objective The aim of the study was to compare the efficacy and mechanical consequences of 2 partial fundoplications performed laparoscopically under the framework of a r and omized , controlled clinical trial . Summary Background Data Although laparoscopic total fundoplication procedures have proven their effectiveness in the control of gastroesophageal reflux , problems remain with the functional consequences after a supra-competent gastric cardia high-pressure zone . Partial fundoplications have been found to be associated with fewer mechanical side effects . Patients and Methods During a 2-year period , 95 patients with gastroesophageal reflux disease were enrolled into a r and omized , controlled single-institution clinical trial comparing a partial posterior ( Toupét , n = 48 ) fundoplication and an anterior partial wrap ( Watson , n = 47 ) . All patients were assessed postoperatively at predefined time points , and the 12-month follow-up data are presented in terms of clinical results and 24-hour pH monitoring variables . Results Both patient groups were strictly comparable at the time of r and omization . All operations were completed laparoscopically , and no serious complications were encountered . During the first postoperative year , a difference regarding the control of reflux symptoms was observed in favor of the posterior fundoplication . Esophageal acid exposure ( % time pH < 4 ) was substantially reduced by both operations but to a significantly lower level after a Toupét compared with the Watson partial fundoplication ( 1.0 ± 0.3 vs. 5.6 ± 1.1 mean ± SEM ; p < 0.001 ) . Postfundoplication symptoms were infrequently recorded with no difference between the groups . Conclusions When performing a laparoscopic partial fundoplication , the posterior modification ( Toupét ) offers advantages in terms of better reflux control compared with an anterior type ( Watson ) This double‐blind , r and omized study compared outcomes of laparoscopic Nissen total fundoplication and anterior partial fundoplication carried out by a single surgeon in a private practice Objective : To compare longer term ( 5-year ) outcomes for reflux control and postsurgery side effects after laparoscopic anterior ( 90 ° and 180 ° ) partial versus Nissen fundoplication for gastroesophageal reflux . Background : Laparoscopic Nissen fundoplication is the most frequently performed surgical procedure for gastroesophageal reflux . It achieves excellent control of reflux , but in some patients it is followed by
Output:
| At 1 and 5 years , dysphagia and gas-related symptoms are lower after 180-degree LAF than after LNF , and esophageal acid exposure and esophagitis are similar , with no differences in heartburn scores , patient satisfaction , dilatations , and reoperation rate . |
MS212199 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: OBJECTIVE To assess and compare the quality of nonstructured and structured abstract s of original research articles in three medical journals . DESIGN Blind , criterion-based observational study . SAMPLE R and om sample of 300 abstract s ( 25 abstract s per journal each year ) of articles published in the British Medical Journal ( BMJ ) , the Canadian Medical Association Journal and the Journal of the American Medical Association ( JAMA ) in 1988 and 1989 ( nonstructured abstract s ) and in 1991 and 1992 ( structured abstract s ) . MAIN OUTCOME MEASURES The quality of abstract s was measured against 33 objective criteria , which were divided into eight categories ( purpose , research design , setting , subjects , intervention , measurement of variables , results and conclusions ) . The quality score was determined by dividing the number of criteria present by the number applicable ; the score varied from 0 to 1 . RESULTS The overall mean quality scores for nonstructured and structured abstract s were 0.57 and 0.74 respectively ( p < 0.001 ) . The frequency in meeting the specific criteria was generally higher for the structured abstract s than for the nonstructured ones . The mean quality score was higher for nonstructured abstract s in JAMA than for those in BMJ ( 0.60 v. 0.54 , p < 0.05 ) . The scores for structured abstract s did not differ significantly between the three journals . CONCLUSIONS The findings support recommendations that promote the use of structured abstract s. Further studies should be performed to assess the effect of time on the quality of abstract s and the extent to which abstract s reflect the content of the articles BACKGROUND AND STUDY AIMS Histological examination of core tissue sample s may have advantages over cytology in endoscopic ultrasound (EUS)-guided sampling . We aim ed to evaluate the feasibility and efficiency of a new 22 G core biopsy needle . PATIENTS AND METHODS Consecutive patients with a pancreatic mass lesion or peri-intestinal lymphadenopathy sequentially underwent fine needle biopsy with both a newly developed 22 G core needle ( the FNB needle ) and a st and ard 22 G fine needle aspiration ( FNA ) needle , in r and omized order . RESULTS In 144 patients , mean age 48 years ( ± st and ard deviation [ SD ] 14 ; range 18 - 82 ) , with 145 lesions ( mean lesion size 39 ± 15 mm , range 15 - 99 ) , EUS-guided sampling was technically feasible with both needles in all patients . Mean number of passes to obtain sufficient tissue was 1.2 ± 0.5 with the core needle vs. 2.5 ± 0.9 with the st and ard needle ( P < 0.001 ) . FNB specimens were adequate for evaluation in 125 ( 86.2 % ) vs. 127 ( 87.6 % ) with FNA ( P = 0.72 ) . Among 139 patients available for follow-up , FNB provided a correct diagnosis in 110 ( 79.1 % ) and FNA in 112 ( 80.6 % ) ( P = 0.73 ) . Sensitivity , specificity , positive and negative predictive values , and accuracy for diagnosis of malignancy were 90 % , 100 % , 100 % , 93 % , 96 % for FNB and 77 % , 100 % , 100 % , 85 % , 92 % for FNA , respectively ( P > 0.05 ) . CONCLUSION FNB with the new 22 G core needle was technically feasible , efficient and comparable to FNA with a st and ard needle . The core needle required fewer passes to provide an adequate sample , offering potentially shorter procedure time Background : Endoscopic ultrasound (EUS)-guided fine needle aspiration ( FNA ) with bedside cytopathology is the gold st and ard for assessment of pancreatic , subepithelial , and other lesions in close proximity to the gastrointestinal tract , but it is time-consuming , has certain diagnostic limitations , and bedside cytopathology is not widely available . Aims : The goal of this study is to compare the diagnostic yield of EUS-guided FNA with on-site cytopathology and EUS-guided core biopsy . Methods : Twenty-six patients with gastrointestinal mass lesions requiring biopsy at a tertiary medical center were included in this retrospective analysis of a prospect i ve cohort . Two core biopsies were taken using a 22 gauge needle followed by FNA guided by a bedside cytopathologist at the same endoscopic session . The diagnostic yield and test characteristics of EUS core biopsy and EUS FNA with bedside cytopathology were examined . Results : The mean number of passes was 3.2 for FNA , and the mean procedure time was 39.4 minutes . The final diagnosis was malignant in 92.3 % . Sensitivity and specificity were 83 % and 100 % , respectively , for FNA , and 91.7 % and 100 % , respectively , for core biopsy . Diagnostic accuracy was 92.3 % for FNA and 84.6 % for core biopsy . The two approaches were in agreement in 88.4 % with a kappa statistic of 0.66 ( 95 % confidence interval 0.33 – 0.99 ) . Conclusions : An approach using two passes with a core biopsy needle is comparable to the current gold st and ard of FNA with bedside cytopathology . The performance of two core biopsies is time-efficient and could represent a good alternative to FNA with bedside cytopathology The specific needle sizes/types used in performing endoscopic ultrasound-guided fine needle aspirations ( EUS-FNA ) vary . The HD ProCore ( ™ ) is a 22-gauge beveled needle allowing for core biopsy along with aspiration material . In this study we compare this needle with a st and ard 22-gauge needle . Between April 1 , 2011 and November 15 , 2011 , 18 patients undergoing EUS-FNA using the HD ProCore ( ™ ) needle were compared to a control group of 18 cases using the st and ard 22-gauge needle . Smears were assessed for : three-dimensional clusters , thick obscuring clusters , monolayer sheets , cellularity , crowded obscuring single cells , blood , and nuclear staining . Cell blocks were assessed for cellularity and presence of diagnostic material . Records were review ed for the overall adequacy , number of FNA passes , and patient follow-up . Overall , the two needle groups demonstrated similar results for the cytology parameters , amount of diagnostic cell block material , adequacy , and accuracy . The mean number of passes to achieve adequacy varied between the groups [ 2.94 for the st and ard 22-gauge needle group versus 2.11 for the beveled needle group ( P=0.03 ) ] with no meaningful difference in case duration between needle groups . No complications were reported . The beveled EUS needle affords similar cytologic interpretability , adequacy , diagnostic accuracy , and amount of cell block material as a st and ard needle . There was a statistically significant trend toward fewer passes to achieve adequacy with the beveled EUS-FNA needle . Therefore , the EUS-FNA needle with a lateral bevel is a diagnostically similar alternative to st and ard endoscopy needles , the possibility that this beveled needle may improve per pass adequacy requires further verification Background and aims : Endoscopic ultrasound‐guided fine needle aspiration ( EUS‐FNA ) has a diagnostic accuracy of 70–90 % , depending on the site under evaluation . In order to improve EUS‐guided tissue sampling a novel 19‐gauge trucut‐type needle has been design ed to obtain core biopsies during EUS . We prospect ively evaluated the safety and accuracy of EUS‐FNA alone versus combined EUS‐FNA and trucut needle biopsy ( TNB ) in patients referred to our Unit over a 3‐year period BACKGROUND AND STUDY AIMS The aims of this study were : firstly , to determine the usefulness of endoscopic ultrasound-guided fine-needle aspiration ( EUS-FNA ) in obtaining tissue diagnosis of intramural and extraintestinal lesions ; secondly , to assess the immediate , acute , and 30-day complications in these patients ; and thirdly , to assess the impact of the tissue diagnoses on patient management . PATIENTS AND METHODS All EUS-FNAs of extraintestinal mass lesions and intramural gastrointestinal tumors over a 26-month period were evaluated prospect ively . The reference st and ards for the final diagnosis were surgery ( n = 20 ) , repeat imaging ( n = 12 ) , clinical follow-up ( n = 4 ) , or death from disease ( n = 2 ) . Four patients were lost to follow-up . RESULTS Forty-two consecutive patients ( 24 men , 18 women ; mean age 59.7 years ) underwent EUS-FNA of extraintestinal mass lesions and intramural gastrointestinal tumors . Previous attempts at tissue diagnosis had failed in 52.4 % of the patients . The EUS-FNA cytological diagnoses included : 17 gastrointestinal stromal tumors , five esophageal cancers , five rectal cancers , one bronchogenic cyst , one foregut duplication cyst , and 13 other miscellaneous diagnoses . The mean number of passes needed to reach a diagnosis was 3.9 ( + /- 2.2 ) . The mean follow-up period was 13.1 months . The sensitivity , specificity , positive predictive value , negative predictive value , and accuracy of EUS-FNA of extraintestinal and intramural tumors were 97 % , 100 % , 100 % , 90 % , and 98 % , respectively . No major complications were encountered . CONCLUSIONS EUS-FNA is a safe and accurate method that can provide a tissue diagnosis in intramural and extraintestinal mass lesions , especially when other modalities have failed . EUS-FNA significantly affects the management of patients by allowing them to be allocated to appropriate treatment and by avoiding the need for more invasive procedures to obtain tissue diagnosis Abstract Objective . Endoscopic ultrasonography (EUS)-guided fine-needle aspiration ( EUS-FNA ) may facilitate tissue sampling for histopathological diagnosis of subepithelial tumors ( SETs ) in the gastrointestinal ( GI ) tract . However , immunohistochemistry is not always feasible using EUS-FNA sample s due to the low quality of specimens often obtained by aspiration . This study aim ed to compare the use of 22-gauge ( G ) EUS-guided fine-needle biopsy ( EUS-FNB ) with 22 G EUS-FNA for core sampling used for histopathological examination , including immunohistochemistry , in patients with GI SETs . Methods . Twenty-eight patients with GI SETs ≥2 cm in size were prospect ively enrolled at five university hospitals in Korea between January and June 2013 . They were r and omized to undergo either EUS-FNB or EUS-FNA . Results . A total of 22 patients was finally analyzed in this study : 10 and 12 patients underwent EUS-FNA and EUS-FNB , respectively . Compared to the EUS-FNA group , the EUS-FNB group had a significantly lower median number of needle passes to obtain macroscopically optimal core sample s ( 4 vs. 2 , p = 0.025 ) ; higher yield rates of macroscopically and histologically optimal core sample s with three needle passes ( 30 % vs. 92 % , p = 0.006 ; 20 % vs. 75 % , p = 0.010 , respectively ) ; and a higher diagnostic sufficiency rate ( 20 % vs. 75 % , p = 0.010 ) . No technical difficulties were encountered in either group . Conclusions . This study shows that EUS-FNB has a better ability to obtain histological core sample s and a higher diagnostic sufficiency rate than EUS-FNA and that EUS-FNB is a feasible , safe , and preferable modality for adequate core sampling for histopathological diagnosis of GI SETs Endoscopic ultrasound-guided fine-needle aspiration ( EUS-FNA ) is widely used for diagnosis of pancreatic lesions . The Echotip Procore Needle ( Wilson-Cook Medical ) is a new 22 G fine biopsy needle ( FNB ) for obtaining core biopsy material at time of EUS . This study aim ed to compare the technical and diagnostic performance of conventional FNA and FNB . Thirty-two patients met the design criteria for this prospect i ve paired cohort study . All lesions sample d were solid ( non-cystic ) pancreatic masses by EUS appearance . Patients were r and omized to receive FNA or FNB by first attempt . A cytopathologist performed on-site evaluations . Sample s were assessed for accuracy of diagnosis , cellularity , contamination , and sufficiency for ancillary studies . Technical and diagnostic performances were compared . Compared to FNA , there was a statistically significant decreased ability of FNB to achieve a diagnosis ( FNA 93.8 % , FNB 28.1 % , P < 0.001 ) . FNB was diagnostically superior to FNA in 1 of 32 cases . Technical failures were observed in five cases due to resistance to advancement of the FNB needle . Regarding operator perceived ease-of-use , FNA outper
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| Although not statistically significant ( P = 0.06 ) , by meta-regression , in the absence of ROSE , FNB showed a relatively better diagnostic adequacy .
The absence of ROSE was associated with a higher SMD , i. e. , in the presence of an onsite pathologist , FNA required relatively fewer passes to establish the diagnosis than in the absence of an onsite pathologist .
Conclusions There is no significant difference in the diagnostic yield between FNA and FNB , when FNA is accompanied by ROSE .
However , in the absence of ROSE , FNB is associated with a relatively better diagnostic adequacy in solid pancreatic lesions .
Also , FNB requires fewer passes to establish the diagnosis |
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