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MS213900 | ***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 explore potential predictors of self-reported paretic arm use at baseline and after task-specific training ( TST ) in survivors of stroke . Design Data were obtained from a r and omized controlled trial of somatosensory stimulation and upper limb TST in chronic stroke . Setting University laboratory . Participants Chronic ( ≥3mo ) survivors of stroke ( N=33 ; mean age , 62y ; mean stroke duration , 38mo ) . Interventions Participants received 12 sessions of TST preceded by either active ( n=16 ) or sham ( n=17 ) somatosensory stimulation to all 3 peripheral nerves . Main Outcome Measures Demographic and clinical characteristics were entered stepwise into multiple linear regression analyses to determine the factors that best predict baseline Motor Activity Log ( MAL ) amount of use rating and change 3 months after TST . Results The Action Research Arm Test ( ARAT ) score predicted the amount of use at baseline ( R2=.47 , P<.001 ) ; in using this model , an ARAT score of 54 ( maximum of 57 ) is required to score 2.5 on the MAL ( use described as between rarely and sometimes ) . After TST the change in the ARAT score predicted the change in the amount of use ( R2=.31 , P=.001 ) . The predictive power of the model for change at 3 months increased if the Fugl-Meyer Assessment wrist component score was added ( R2=.41 , P=.001 ) . Conclusions Utilization of the paretic upper limb in activities of daily living requires high functional ability . The increase in self-reported arm use after TST is dependent on the change in functional ability . These results provide further guidance for rehabilitation decisions OBJECTIVE To estimate minimal clinical ly important difference ( MCID ) values of several upper-extremity measures early after stroke . DESIGN Data in this report were collected during the Very Early Constraint-induced Therapy for Recovery of Stroke trial , an acute , single-blind r and omized controlled trial of constraint-induced movement therapy . Subjects were tested at the prer and omization baseline assessment ( average days poststroke , 9.5d ) and the first posttreatment assessment ( average days poststroke , 25.9d ) . At each time point , the affected upper extremity was evaluated with a battery of 6 tests . At the second assessment , subjects were also asked to provide a global rating of perceived changes in their affected upper extremity . Anchor-based MCID values were calculated separately for the affected dominant upper extremities and the affected nondominant upper extremities for each of the 6 tests . SETTING Inpatient rehabilitation hospital . PARTICIPANTS Fifty-two people with hemiparesis poststroke . INTERVENTIONS Not applicable . MAIN OUTCOME MEASURES Estimated MCID values for grip strength , composite upper-extremity strength , Action Research Arm Test ( ARAT ) , Wolf Motor Function Test ( WMFT ) , Motor Activity Log ( MAL ) , and duration of upper-extremity use as measured with accelerometry . RESULTS MCID values for grip strength were 5.0 and 6.2 kg for the affected dominant and nondominant sides , respectively . MCID values for the ARAT were 12 and 17 points , for the WMFT function score were 1.0 and 1.2 points , and for the MAL quality of movement score were 1.0 and 1.1 points for the 2 sides , respectively . MCID values were indeterminate for the dominant ( composite strength ) , the nondominant ( WMFT time score ) , and both affected sides ( duration of use ) for the other measures . CONCLUSIONS Our data provide some of the first estimates of MCID values for upper-extremity st and ardized measures early after stroke . Future studies with larger sample sizes are needed to refine these estimates and to determine whether MCID values are modified by time poststroke This study explored relationships between upper-limb ( UL ) functional limitations and self-reported disability in stroke patients with relatively pure motor hemiparesis who were enrolled in an acute rehabilitation treatment trial . All participants were enrolled in the VECTORS ( Very Early Constraint Treatment for Recovery from Stroke ) study . VECTORS is a single-center pilot clinical trial of early application of constraint-induced movement therapy ( CIMT ) . All 39 subjects who completed 90 days of VECTORS were included in this analysis . Trained study personnel who were blinded to the treatment type performed all evaluations . Data in this article examine relationships between assessment s performed 90 days after stroke . Functional limitation measures included the Action Research Arm ( ARA ) test and Wolf Motor Function Test ( WMFT ) , and self-reported disability measures included the Functional Independence Measure ( FIM ) and Motor Activity Log ( MAL ) ( by telephone ) . Mean plus or minus st and ard deviation time from stroke onset to r and omization was 9.4 plus or minus 4.3 days , and median time to follow-up was 99 days ( range 68 - 178 ) . Subjects with perfect or near-perfect scores on the ARA test or WMFT reported residual disability on the FIM and MAL . Quality of movement on the WMFT ( functional ability score ) was not strongly associated with self-reported frequency , and speed of movement on the WMFT ( timed score ) was not associated with self-reported frequency ( MAL amount of use ) . In this early UL intervention trial , we found that perceived disability measures captured information that was not assessed by functional limitation and impairment scales . Our results indicate that excellent motor recovery as measured by functional limitation and impairment scales did not equal restoration of everyday productive UL use and speed of task completion did not translate to actual use . Our results confirm the need for a measurement strategy that is sensitive to change , assesses a broad performance range , and detects meaningful clinical improvements in early rehabilitation intervention trials BACKGROUND AND PURPOSE Of all stroke survivors , 30 % to 66 % are unable to use their affected arm in performing activities of daily living . Although forced use therapy appears to improve arm function in chronic stroke patients , there is no conclusive evidence . This study evaluates the effectiveness of forced use therapy . METHODS In an observer-blinded r and omized clinical trial , 66 chronic stroke patients were allocated to either forced use therapy ( immobilization of the unaffected arm combined with intensive training ) or a reference therapy of equally intensive bimanual training , based on Neuro-Developmental Treatment , for a period of 2 weeks . Outcomes were evaluated on the basis of the Rehabilitation Activities Profile ( activities ) , the Action Research Arm ( ARA ) test ( dexterity ) , the upper extremity section of the Fugl-Meyer Assessment scale , the Motor Activity Log ( MAL ) , and a Problem Score . The minimal clinical ly important difference ( MCID ) was determined at the onset of the study . RESULTS One week after the last treatment session , a significant difference in effectiveness in favor of the forced use group compared with the bimanual group ( corrected for baseline differences ) was found for the ARA score ( 3.0 points ; 95 % CI , 1.3 to 4.8 ; MCID , 5.7 points ) and the MAL amount of use score ( 0.52 points ; 95 % CI , 0.11 to 0.93 ; MCID , 0.50 ) . The other parameters revealed no significant differential effects . One-year follow-up effects were observed only for the ARA . The differences in treatment effect for the ARA and the MAL amount of use scores were clinical ly relevant for patients with sensory disorders and hemineglect , respectively . CONCLUSIONS The present study showed a small but lasting effect of forced use therapy on the dexterity of the affected arm ( ARA ) and a temporary clinical ly relevant effect on the amount of use of the affected arm during activities of daily living ( MAL amount of use ) . The effect of forced use therapy was clinical ly relevant in the subgroups of patients with sensory disorders and hemineglect , respectively Stroke is a leading cause of adult disability and the recovery of motor function is important for independence in activities of daily living . Predicting motor recovery after stroke in individual patients is difficult . Accurate prognosis would enable realistic rehabilitation goal - setting and more efficient allocation of re sources . The aim of this study was to test and refine an algorithm for predicting the potential for recovery of upper limb function after stroke . Forty participants were prospect ively enrolled within 3 days of ischaemic stroke . First , shoulder abduction and finger extension strength were grade d 72 h after stroke onset to compute a shoulder abduction and finger extension score . Secondly , transcranial magnetic stimulation was used to assess the functional integrity of descending motor pathways to the affected upper limb . Third , diffusion-weighted magnetic resonance imaging was used to assess the structural integrity of the posterior limbs of the internal capsules . Finally , these measures were combined in the PREP algorithm for predicting an individual 's potential for upper limb recovery at 12 weeks , measured with the Action Research Arm Test . A cluster analysis was used to independently group patients according to Action Research Arm Test score at 12 weeks , for comparison with predictions from the PREP algorithm . There was excellent correspondence between the cluster analysis of Action Research Arm Test score at 12 weeks and predictions made with the PREP algorithm . The algorithm had positive predictive power of 88 % , negative predictive power of 83 % , specificity of 88 % and sensitivity of 73 % . This study provides preliminary data in support of the PREP algorithm for the prognosis of upper limb recovery in individual patients . PREP may enable tailored planning of rehabilitation and more accurate stratification of patients in clinical trials In this study , we compared the responsiveness and validity of the Box and Block Test ( BBT ) , the Nine-Hole Peg Test ( NHPT ) , and the Action Research Arm Test ( ARAT ) . We r and omized 59 patients with stroke into one of three rehabilitation treatments for 3 weeks . We administered six outcome measures ( BBT , NHPT , ARAT , Fugl-Meyer Assessment [ FMA ] , Motor Activity Log [ MAL ] , and Stroke Impact Scale [ SIS ] h and function domain ) pretreatment and posttreatment . We used the st and ardized response mean ( SRM ) to examine responsiveness and the Spearman rank correlation coefficient ( rho ) to examine concurrent validity . The BBT , NHPT , and ARAT were moderately responsive to change and not significantly different ( SRM = 0.64 - 0.79 ) . The correlations within the BBT , NHPT , and ARAT were moderate to good at pretreatment ( rho = -0.55 to -0.80 ) and posttreatment ( rho = -0.57 to -0.71 ) . The BBT and ARAT showed fair to moderate correlations with the FMA , MAL , and SIS h and function domain at pretreatment and posttreatment ( rho = 0.31 - 0.59 ) , whereas the NHPT demonstrated low to fair correlations with the FMA and MAL ( rho = -0.16 to -0.33 ) and moderate correlations with the SIS h and function domain ( rho = -0.58 to -0.66 ) . Our results indicate that the BBT , NHPT , and ARAT are suitable to detect changes over time . While simultaneously considering the responsiveness and validity attributes , the BBT and ARAT can be considered more appropriate for evaluating dexterous function than the NHPT . Further studies with larger sample s are needed to vali date these findings OBJECTIVES To determine the intra- and interrater reliability of the Action Research Arm ( ARA ) test , to assess its ability to detect a minimal clinical ly important difference ( MCID ) of 5.7 points , and to identify less reliable test items . DESIGN Intrarater reliability of the sum scores and of individual items was assessed by comparing ( 1 ) the ratings of the laboratory measurements of 20 patients with the ratings of the same measurements recorded on videotape by the original rater , and ( 2 ) the repeated ratings of videotaped measurements by the same rater . Interrater reliability was assessed by comparing the ratings of the videotaped measurements of 2 raters . The result ing limits of agreement were compared with the MCID . PATIENTS Stratified sample , based on the intake ARA score , of 20 chronic stroke patients ( median age , 62yr ; median time since stroke onset , 3.6yr ; mean intake ARA score , 29.2 ) . MAIN OUTCOME MEASURES Spearman 's rank-order correlation coefficient ( Spearman 's rho ) ; intraclass correlation coefficient ( ICC ) ; mean difference and limits of agreement , based on ARA sum scores ; and weighted kappa , based on individual items . RESULTS All intra- and interrater Spearman 's rho and ICC values were higher than .98 . The mean difference between ratings was highest for the interrater pair ( .75 ; 95 % confidence interval , .02 - 1.48 ) , suggesting a small systematic difference between raters . Intrarater limits of agreement were -1.66 to 2.26 ; interrater limits of agreement were -2.35 to 3.85 . Median weighted kappas exceeded .92 . CONCLUSION The high intra- and interrater reliability of the ARA test was confirmed , as was its ability to detect a clinical ly relevant difference of 5.7 points To test the clinical counterpart of the learned nonuse theory , 25 chronic hemiplegic stroke and head-injured patients with minimal to moderate upper extremity extensor muscle function were required to keep their uninvolved upper extremities within a h and -enclosed sling during waking hours over a 2-week interval . During this forced use period and for 1 year thereafter , changes in force or time-based measures among 21 functional tasks were compared to values at the sixth baseline session , a preintervention time when relearning had plateaued . Significant ( P less than 0.05 , Friedman 's repeated measures followed by Tukey multiple comparison tests ) changes were seen in 19 of the 21 tasks with most persisting at the 1-year follow-up . There were no apparent differences between right- and left-sided involvement or between stroke versus head injury clients ( Mann-Whitney
Output:
| Best evidence synthesis determined moderate positive evidence for using the ARAT with people without limb spasticity : intra-rater reliability ( ICC 0.71 ( 95 % CI 0.53 - 0.89 ) to 0.99 ( 95 % CI 0.98 , 0.99 ) ) ; responsiveness ( ROC curve 0.72 - 0.88 , SRM 0.89 ) ; and regarding construct validity , it is a valid measure of activity limitation .
Gaps in evidence were found for inter and test-retest reliability , measurement error , content validity , structural validity , floor and ceiling effects .
CONCLUSIONS The ARAT is an appropriate measure of activity limitation post-stroke and should be considered for use with people with TBI ; evidence for people with upper limb spasticity is limited . |
MS213901 | ***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: In traditional Chinese medicine ( TCM ) , the Yiqigubiao pill is commonly used to enhance physical fitness . The current clinical trial was design ed to evaluate the efficacy and safety of the Yiqigubiao pill as an adjuvant therapy for patients with stable chronic obstructive pulmonary disease ( COPD ) . The current trial was a r and omized , double-blind , placebo-controlled superiority trial . The participants were recruited from out patients at the Traditional Chinese Medicine Hospital affiliated with Xinjiang Medical University ( Ürümqi , China ) between February and September 2012 . All participants were patients with stable COPD that were r and omized to the Yiqigubiao pill ( YQGB ; n=84 ) or placebo ( Pb ; n=87 ) groups . The occurrences of acute exacerbation ( AE ) of COPD during the trial were recorded . Lung function value assessment s , scoring of life quality and exercise endurance , arterial blood gas analysis and serum inflammatory cytokines level determination were performed prior to and throughout the study . A total of 139 participants completed the intervention and 132 participants completed the study . The interval between the initial intervention and the first AE COPD was greater in the YQGB group compared with the Pb group ( P<0.01 ) . The incidence rate of AE COPD was lower in the YQGB group than in the Pb group ( P<0.01 ) . Subsequent to the intervention or at the end of the study , the 6-min walking distance difference was longer in the YQGB group compared with the Pb group ( P<0.01 ) . The scores reflecting life quality decline became lower in the YQGB group ( P<0.01 ) . The serum levels of proinflammatory factors were downregulated to a greater extent in the YQGB group compared with the Pb group . Thus , the Yiqigubiao pill is an efficient and safe adjuvant therapy for the treatment of stable patients with COPD Abstract The aim of this study was to determine if components of the COPD Assessment Test ( CAT ) , a vali date d health status impairment instrument , had additional utility in identifying patients at risk for COPD in whom spirometry testing is appropriate . This study was part of the Canadian Obstructive Lung Disease prevalence study . Consenting participants ≥ 40 years of age were identified by r and om digit dialing . Smoking history , 8-item CAT scores , and post-bronchodilator spirometry were recorded for each . Stepwise logistic regression analysis was used to identify variables related to the presence of airway obstruction and a final logistic model was developed which best predicted COPD in this sample . Of the 801 individuals approached , 532 were included : 51 ( 9.6 % ) had COPD , the majority ( 92 % ) of whom fit GOLD I or II severity criteria . Items that correlated significantly with a COPD diagnosis included the CAT total score ( p = 0.01 ) and its breathlessness ( p < 0.0001 ) and phlegm ( p = 0.001 ) components . The final logistic model included : age ( < 55 or ≥55 years ) , smoking status ( current , former , never ) and the CAT breathlessness score ( ordinal scale 0–5 ) . The area under the receiver-operating characteristic curve for this model was 0.77 , sensitivity was 77.6 % , specificity was 64.9 % and the positive likelihood ratio was 2.21 . In summary , the triad of smoking history , age at least 55 years and the presence of exertional breathlessness were key elements of a simple model which had reliable measurement properties when tested in a r and om population . This may help identify patients at risk for COPD for whom spirometry testing is recommended This study aim ed to evaluate the efficacy of comprehensive therapy based on traditional Chinese medicine ( TCM ) patterns on older patients with chronic obstructive pulmonary disease ( COPD ) through a four-center , open-label , r and omized controlled trial . Patients were divided into the trial group treated using conventional western medicine and Bu-Fei Jian-Pi granules , Bu-Fei Yi-Shen granules , and Yi-Qi Zi-Shen granules based on TCM patterns respectively ; and the control group treated using conventional western medicine . A total of 136 patients ⩾ 65 years completed the study , with 63 patients comprising the trial group and 73 comprising the control group . After the six-month treatment and the 12-month follow-up period , significant differences were observed between the trial and control groups in the following aspects : frequency of acute exacerbation ( P ⩽ 0.040 ) , duration of acute exacerbation ( P = 0.034 ) , symptoms ( P ⩽ 0.034 ) , 6-min walking distance ( 6MWD ) ( P ⩽ 0.039 ) , dyspnea scale ( P ⩽ 0.036 ) ; physical domain ( P ⩽ 0.019 ) , psychological domain ( P ⩽ 0.033 ) , social domain ( P ⩽ 0.020 ) , and environmental domain ( P ⩽ 0.044 ) of the WHOQOL-BREF question naire ; and daily living ability domain ( P ⩽ 0.007 ) , social activity domain ( P ⩽ 0.018 ) , depression symptoms domain ( P ⩽ 0.025 ) , and anxiety symptoms domain ( P ⩽ 0.037 ) of the COPD -QOL . No differences were observed between the trial and control groups with regard to FVC , FEV1 , and FEV1 % OBJECTIVE To study the therapeutic effect Bufei granule , which is a traditional Chinese drug that can enhance the immune function of the lung , on patients with stable chronic obstructive pulmonary disease ( COPD ) . METHODS This is a r and omized , double blinded , placebo-controlled , and multicenter clinical study . Three medical centers in Tianjin , China , participated in the trial . A total of 140 patients with stable COPD were enrolled and r and omized into two groups , with 70 patients in each . The treatment group was treated with Bufei granule , while the control group received Bufei placebo . The pharmacological treatment lasted for 12 weeks from the date of enrollment . Then , the indexes of patients were observed . Data were analyzed to study the effect of Bufei granule , with the frequency of acute exacerbation as the primary outcome . Traditional Chinese Medicine syndromes , Modified British Medical Research Council dyspnea scale score , St. George 's respiratory question naire scores , pulmonary function , and serum inflammatory marker levels [ including interleukin-6 ( IL-6 ) , interleukin-8 , tumor necrosis factor-alpha , and transformation growth factor-beta1 ] were the secondary outcomes . RESULTS During the 12-week treatment , treatment and control groups had no adverse reactions . The analysis of the indexes obtained from all patients showed that the therapeutic effect in the treatment group was significantly better than that in the control group because most of the similar probabilities of primary and secondary outcomes were less than 0.05 , except for the level of IL-6 . CONCLUSION Bufei granule can treat patients with stable COPD by lowering the frequency of acute exacerbation , improving the quality of life , and alleviating the severity of inflammation Background : A Chinese herb formula Yufeining ( YFN ) has showed promise in the treatment of stable chronic obstructive pulmonary disease ( COPD ) , less is known that the impact of YFN in combination with st and ard Western treatments on lung inflammation . This study evaluated the safety and efficacy of YFN as a treatment for stable COPD and as an anti-inflammatory agent . Methods : Sixty patients with stable COPD were r and omly assigned to two treatment groups ( YFN treatment , N = 30 ; placebo treatment , N = 30 ) . Both groups received inhaled steroids and bronchodilators during an 8-week intervention , and patient status was assessed at 8 weeks later and 4 months after treatment . The primary outcome included clinical efficacy . The secondary outcomes involved CAT score , mMRC grade , six-minute walking distance ( 6MWD ) . IL-8 , TNF-&agr ; , IL-17A , LTB4 , TGF-&bgr;1 and CRP were also detection in peripheral serum , as well as adverse reaction conditions . Results : The YFN group demonstrated a significant improvement in clinical efficacy ( compare 89.3 % to 63.3 % in the placebo group ; P < 0.05 ) . CAT scores and mMRC grade s significantly decreased ( P < 0.05 , P < 0.01 ) , and 6MWD significantly increased ( P<0.05 ) , after YFN treatment . The levels of IL-8 , TNF-&agr ; , LTB4 and CRP decreased significantly after 8 weeks of treatment compared to baseline levels in both groups . Only in the YFN treatment group , the levels of IL-17A decreased significantly after treatment compared to baseline levels ( P < 0.05 ) . No changes were observed inTGF-&bgr;1 from pre-to post-treatment in either group ( P > 0.05 ) . Serum levels of IL-8 , TNF-&agr ; , IL-17A , LTB4 and CRP decreased significantly after YFN treatment compared to the placebo group ( P < 0.05 ) . Conclusion : A combinatorial treatment approach with YFN , inhaled steroids and bronchodilators produced a clinical ly effective treatment for stable COPD , leading to a significant decrease in circulating inflammatory mediators . The study appeared YFN was safety . Clinical trial registration number : No. ChiCTR-IOR-17013577 Purpose Recurrence of acute exacerbations has a major impact on patients with COPD . Therefore , effective prevention and treatment of exacerbation is crucial in the management of COPD , especially for patients with moderate to severe disease . This study evaluated the effectiveness of YuPingFeng granule administration in preventing exacerbation and improving symptom score , as well as its long-term ( 1 year ) safety profile , in patients with COPD . Patients and methods This was a r and omized , double-blind , parallel , placebo-controlled study of 240 patients from eight centers in China . Participants were eligible if they had mild to severe COPD as defined by Global Initiative for Chronic Obstructive Lung Disease , had a history of at least two COPD exacerbations or one hospitalization within the previous year , and had remained clinical ly stable for over 4 weeks before the study . They were r and omly assigned to receive 5 g of YuPingFeng or placebo , three times per day , for 1 year . The primary end point was the exacerbation rate over 1 year , and the analysis was by intention to treat . Secondary end points included symptom score , which was assessed by COPD assessment test ( CAT ) score and safety profiles . This trial was registered in the Chinese Clinical Trial Registry ( http://www.chictr.org.cn ; registration number : ChiCTR-IPR-15007023 ) . Results The YuPingFeng group had a significantly lower exacerbation rate than the placebo group ( 1.15 vs 1.55 ; risk ratio=0.677 [ 95 % CI 0.531–0.863 ] ; P=0.002 ) and a significantly reduced risk of second exacerbation ( 95 % CI 0.326–0.772 ; P=0.002 ) . After treatment , the mean change in the CAT score in the YuPingFeng group ( −4.41±7.01 ) differed significantly from that in the placebo group ( −2.49±5.31 ; P=0.001 ) . YuPingFeng was well tolerated . Conclusion YuPingFeng granules can be considered as a treatment option for COPD ; this treatment prevents acute exacerbations of COPD and has a good safety profile
Output:
| RESULTS This systematic review and meta- analysis will provide a high- quality comprehensive evaluation of the efficacy and safety based on current literature evidence of CHM intervention for stable COPD .
The conclusion of this study will present the evidence of whether CHM is an effective and safe intervention for stable COPD patients |
MS213902 | ***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 Influenza and its complications are common at all ages , especially in children . Vaccines and anti-influenza drugs aim to prevent it . Preventative approaches with favorable risk profiles should be considered for flu , particularly since the evidence of the efficacy of anti-viral drugs is debated . METHODS This pragmatic clinical trial was conducted in the Brazilian Public Health System in Petrópolis ( BPHSP ) with children aged from 1 to 5 years old . The medications used were mainly selected based on in vitro experiments ( InfluBio ) , and in successful qualitative clinical experiences ( Homeopathic Complex ) . Following informed parental consent , subjects were r and omly distributed , in a blind manner , to three experimental groups : Homeopathic Complex , Placebo , and InfluBio . BPHSP health agents collected flu and acute respiratory infection symptomatic episodes monthly following the established protocol . The number of these episodes was registered in one year ( 2009 - 2010 ) . RESULTS Out of the 600 children recruited , 445 ( 74.17 % ) completed the study ( 149 : Homeopathic complex ; 151 : Placebo ; 145 : InfluBio ) . The number of flu and acute respiratory infection symptomatic episodes detected in this clinical trial was low ; however , it was different between homeopathic groups and placebo ( p < 0.001 ) . In the first year post-intervention , 46/151 ( 30.5 % ) of children in the placebo group developed 3 or more flu and acute respiratory infection episodes , while there was no episode in the group of 149 children who used Homeopathic Complex , and only 1 episode in the group of 145 ( 1 % ) children who received InfluBio . CONCLUSION These results suggested that the use of homeopathic medicines minimized the number of flu and acute respiratory infection symptomatic episodes in children , signalizing that the homeopathic prophylactic potential should be investigated in further studies OBJECTIVE To assess the effectiveness of a homeopathic ear drop for treatment of otalgia in children with acute otitis media ( AOM ) . METHODS Children with AOM were enrolled in the study at the time of diagnosis and r and omized to receive either st and ard therapy alone or st and ard therapy plus a homeopathic ear drop solution that was to be used on as needed basis for up to 5 days . Parents of children in both treatment groups rated the severity of 5 AOM symptoms twice daily for 5 days in a symptom diary . A symptom score was computed for each assessment with lower scores denoting less severe symptoms . Parents of children r and omized to receive ear drops also recorded information regarding symptoms being treated and response to treatment . RESULTS A total of 119 eligible children were enrolled in the study ; symptom diaries were received from 94 ( 79 % ) . Symptom scores tended to be lower in the group of children receiving ear drops than in those receiving st and ard therapy alone ; these differences were significant at the second and third assessment s ( P = 0.04 and P = 0.003 , respectively ) . In addition , the rate of symptom improvement was faster in children in the ear drop group compared with children in st and ard therapy alone group ( P = 0.002 ) . The most common reason for administration of ear drops was ear pain , recorded for 93 doses ; improvement was noted after 78.4 % of doses for this indication . There were no significant side effects related to use of the ear drops . CONCLUSIONS This study suggests that homeopathic ear drops were moderately effective in treating otalgia in children with AOM and may be most effective in the early period after a diagnosis of AOM . Pediatricians and other primary health care providers should consider homeopathic ear drops a useful adjunct to st and ard therapy OBJECTIVE To pilot a model for determining whether homoeopathic treatment of children suffering from glue ear is more effective than st and ard GP care at producing a return to normal hearing ( a hearing loss of less than 20 dB ) within 12 months . DESIGN Non-blind , r and omized controlled trial . SETTING General practice in two locations in southern Engl and . SUBJECTS Thirty-three children aged 18 months to 8 years with otitis media with effusion , hearing loss > 20 dB and an abnormal tympanogram . OUTCOME MEASURES Hearing loss , tympanogram , referrals to specialists and number of courses of antibiotics at 12 month follow-up . RESULTS A higher proportion of children receiving homoeopathic care had a hearing loss less then 20 dB at follow-up ( 64 vs 56 % ) , though this difference did not reach statistical significance ( 95 % confidence interval for the difference between means of -25 and 42 % ) . More homoeopathy patients than controls had a normal tympanogram ( 75 vs 31 % , P = 0.015 ) . Referrals to specialists and antibiotic consumption was lower in the homoeopathy group , though differences between groups did not reach statistical significance . CONCLUSION Further research comparing homoeopathy to st and ard care is warranted . Assuming recovery rates of 50 and 30 % in homoeopathy and st and ard care groups respectively , 270 patients would be needed for a definitive trial Background The present study was initiated to investigate the effectiveness , safety and tolerability of complex homeopathic CalSuli-4 - 02 tablets on prevention of recurrent acute upper respiratory tract infections ( URTIs ) in children , in comparison to another complex homeopathic product . Methods The study was design ed as a prospect i ve , multicenter , r and omized , open , clinical trial with two parallel treatment groups at four outpatient pediatric clinics in Russia . Children aged ≤ 6 years with susceptibility to acute URTIs ( ≥ three occasions during the last 6 months ) were r and omized to receive either CalSuli-4 - 02 or a comparator homeopathic product ( control group ) for 3 weeks . Primary outcome was the frequency of acute URTIs after 3 and 6 months post-treatment follow-up . Secondary endpoints were changes in complaints and symptoms ( total and individual scores ) , treatment satisfaction , antibiotic use , safety and tolerability . Results The intention-to-treat analysis involved 200 children ( CalSuli-4 - 02 : N = 99 , Control : N = 101 ) . In both treatment groups , the median number of acute URTIs was one for 3 months and two , respectively , for the full 6 months post-treatment ( Relative Risk : 0.86 ( 95 % -CI : 0.72–1.03 ) , p = 0.1099 ) . Seasons had no influence on the outcome . At the end of study , CalSuli-4 - 02 had overall higher odds of getting lower complaints severity total score ( Odds ratio : 1.99 ( 95 % -CI : 1.31–3.02 ) , p = 0.0012 ) and showing symptom improvement ( Odds ratio : 1.93 ( 95 % -CI : 1.25–3.00 ) , p = 0.0033 ) . Specifically , the complaint “ appetite disorder ” and the symptom “ child ’s activities ” significantly improved more in the CalSuli-4 - 02 group ( p = 0.0135 and p = 0.0063 , respectively ) . Antibiotic use was decreased in both treatment groups at the study end . Overall assessment for satisfaction with and tolerability of treatment was higher with CalSuli-4 - 02 . A low number of non-serious adverse drug reactions was reported ( CalSuli-4 - 02 : N = 4 , Control : N = 1 ) . Conclusions Both complex homeopathic products led to a comparable reduction of URTIs . In the CalSuli-4 - 02 group , significantly less URTI-related complaints and symptoms and higher treatment satisfaction and tolerability were detected . The observation that the use of antibiotics was reduced upon treatment with the complex homeopathic medications , without the occurrence of complications , is interesting and warrants further investigations on the potential of CalSuli-4 - 02 as an antibiotic sparing option . Clinical trial registration numberRoszdravnadzor : Study No BACKGROUND Acute viral tonsillitis is an upper respiratory tract infection prevalent in school-aged children . Because this condition is self-limiting , conventional treatment options are usually palliative . Homeopathic remedies are a useful alternative to conventional medications in acute uncomplicated upper respiratory tract infections in children , offering earlier symptom resolution , cost-effectiveness , and fewer adverse effects . This study aim ed to determine the efficacy of a homeopathic complex on the symptoms of acute viral tonsillitis in African children in South Africa . METHODS This was a r and omized , double-blind , placebo-controlled , 6-day pilot study . Thirty children , age 6 to 12 years , with acute viral tonsillitis were recruited from a primary school in Gauteng , South Africa . Participants took two tablets of the medication four times daily . The treatment group received lactose tablets medicated with the homeopathic complex ( Atropa belladonna D4 , Calcarea phosphoricum D4 , Hepar sulphuris D4 , Kalium bichromat D4 , Kalium muriaticum D4 , Mercurius protoiodid D10 , and Mercurius biniodid D10 ) . The placebo consisted of the unmedicated vehicle only . The Wong-Baker FACES Pain Rating Scale measured pain intensity , and a Symptom Grading Scale assessed changes in tonsillitis signs and symptoms . RESULTS The treatment group had a statistically significant improvement in the following symptoms compared with the placebo group : pain associated with tonsillitis , pain on swallowing , erythema and inflammation of the pharynx , and tonsil size . CONCLUSION The homeopathic complex used in this study exhibited significant anti-inflammatory and pain-relieving qualities in children with acute viral tonsillitis . No patients reported any adverse effects . These preliminary findings are promising ; however , the sample size was small and therefore a definitive conclusion can not be reached . A larger , more inclusive research study should be undertaken to verify the findings of this study We investigated the clinical effectiveness of a homeopathic add-on therapy in a pediatric sub population with upper respiratory tract infections ( URTI ) in a r and omized , controlled , multinational clinical trial . Patients received either on-dem and symptomatic st and ard treatment ( ST-group ) or the same ST plus a homeopathic medication ( Influcid ; IFC-group ) for 7 days . Outcome assessment was based on symptom and fever resolution and the Wisconsin Upper Respiratory Symptom Survey–21 ( WURSS-21 ) . A total of 261 pediatric ( < 12 years ) patients ( 130 IFC-group ; 131 ST-group ) were recruited in Germany and the Ukraine . The IFC-group used less symptomatic medication , symptoms resolved significantly earlier ( P = .0001 ) , had higher proportions of fever-free children from day 3 onwards , and the WURSS-assessed global disease severity was significantly less ( P < .0001 ) during the entire URTI episode . One adverse event ( vomiting ) was possibly related to IFC . IFC as add-on treatment in pediatric URTI reduced global disease severity , shortened symptom resolution , and was safe in use Cough is a frequent symptom associated to upper respiratory tract infections ( URTIs ) and , although being self-limiting , it might deeply affect the quality of life . Homeopathic products are often employed by patients to treat cough , but the evidence on their efficacy is scarce . Thus , we tested the efficacy of a homeopathic syrup in treating cough arising from URTIs with a r and omized , double blind , placebo controlled clinical trial . Patients were treated with either the homeopathic syrup or a placebo for a week , and recorded cough severity in a diary by means of a verbal category-descriptive score for two weeks . Sputum viscosity was assessed with a viscosimeter before and after 4 days of treatment ; patients were also asked to provide a subjective evaluation of viscosity . Eighty patients were r and omized to receive placebo ( n = 40 ) or the homeopathic syrup ( n = 40 ) . All patients completed the study . In each group cough scores decreased over time , however , after 4 and 7 days of treatment , cough severity was significantly lower in the homeopathic group than in the placebo one ( p < 0.001 and p = 0.023 , respectively ) . Sputum was collected from 53 patients : in both groups its viscosity significantly decreased after 4 days of treatment ( p < 0.001 ) ; however , viscosity was significantly lower in the homeopathic group ( p = 0.018 ) . Instead , the subjective evaluation did not significantly differ between the two groups ( p = 0.059 ) . No adverse events related to any treatment were reported . We concluded that the homeopathic syrup employed in the study was able to effectively reduce cough severity and sputum viscosity , thereby representing a valid remedy for the management of acute cough induced by URTIs BACKGROUND The use of antibiotics in the initial treatment of acute otitis media is currently being question ed . Homeopathy has been used historically to treat this illness , but there have been no method ologically rigorous trials to determine whether there is a positive treatment effect . METHODS A r and omized double blind placebo control pilot study was conducted in a private pediatric practice in Seattle , WA . Seventy-five children ages 18 months to 6 years with middle ear effusion and ear pain and /or fever for no more
Output:
| Pooling of two prevention and two treatment studies did not show any benefit of homeopathic medicinal products compared to placebo on recurrence of ARTI or cure rates in children .
We found no evidence to support the efficacy of homeopathic medicinal products for ARTIs in children . |
MS213903 | ***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 —The congenital long-QT syndrome ( LQTS ) is caused by mutations on several genes , all of which encode cardiac ion channels . The progressive underst and ing of the electrophysiological consequences of these mutations opens unforeseen possibilities for genotype-phenotype correlation studies . Preliminary observations suggested that the conditions ( “ triggers ” ) associated with cardiac events may in large part be gene specific . Methods and Results —We identified 670 LQTS patients of known genotype ( LQT1 , n=371 ; LQT2 , n=234 ; LQT3 , n=65 ) who had symptoms ( syncope , cardiac arrest , sudden death ) and examined whether 3 specific triggers ( exercise , emotion , and sleep/rest without arousal ) differed according to genotype . LQT1 patients experienced the majority of their events ( 62 % ) during exercise , and only 3 % occurred during rest/sleep . These percentages were almost reversed among LQT2 and LQT3 patients , who were less likely to have events during exercise ( 13 % ) and more likely to have events during rest/sleep ( 29 % and 39 % ) . Lethal and nonlethal events followed the same pattern . Corrected QT interval did not differ among LQT1 , LQT2 , and LQT3 patients ( 498 , 497 , and 506 ms , respectively ) . The percent of patients who were free of recurrence with & bgr;-blocker therapy was higher and the death rate was lower among LQT1 patients ( 81 % and 4 % , respectively ) than among LQT2 ( 59 % and 4 % , respectively ) and LQT3 ( 50 % and 17 % , respectively ) patients . Conclusions —Life-threatening arrhythmias in LQTS patients tend to occur under specific circumstances in a gene-specific manner . These data allow new insights into the mechanisms that relate the electrophysiological consequences of mutations on specific genes to clinical manifestations and offer the possibility of complementing traditional therapy with gene-specific approaches BACKGROUND beta-blockers are routinely prescribed in congenital long-QT syndrome ( LQTS ) , but the effectiveness and limitations of beta-blockers in this disorder have not been evaluated . METHODS AND RESULTS The study population comprised 869 LQTS patients treated with beta-blockers . Effectiveness of beta-blockers was analyzed during matched periods before and after starting beta-blocker therapy , and by survivorship methods to determine factors associated with cardiac events while on prescribed beta-blockers . After initiation of beta-blockers , there was a significant ( P<0.001 ) reduction in the rate of cardiac events in prob and s ( 0.97+/-1.42 to 0.31+/-0.86 events per year ) and in affected family members ( 0 . 26+/-0.84 to 0.15+/-0.69 events per year ) during 5-year matched periods . On-therapy survivorship analyses revealed that patients with cardiac symptoms before beta-blockers ( n=598 ) had a hazard ratio of 5.8 ( 95 % CI , 3.7 to 9.1 ) for recurrent cardiac events ( syncope , aborted cardiac arrest , or death ) during beta-blocker therapy compared with asymptomatic patients ; 32 % of these symptomatic patients will have another cardiac event within 5 years while on prescribed beta-blockers . Patients with a history of aborted cardiac arrest before starting beta-blockers ( n=113 ) had a hazard ratio of 12.9 ( 95 % CI , 4.7 to 35.5 ) for aborted cardiac arrest or death while on prescribed beta-blockers compared with asymptomatic patients ; 14 % of these patients will have another arrest ( aborted or fatal ) within 5 years on beta-blockers . CONCLUSIONS beta-blockers are associated with a significant reduction in cardiac events in LQTS patients . However , syncope , aborted cardiac arrest , and LQTS-related death continue to occur while patients are on prescribed beta-blockers , particularly in those who were symptomatic before starting this therapy BACKGROUND Eight r and omized trials have evaluated whether the prophylactic use of an implantable cardioverter-defibrillator ( ICD ) improves survival among patients who are at risk for sudden death due to left ventricular systolic dysfunction but who have not had a life-threatening ventricular arrhythmia . We assessed the cost-effectiveness of the ICD in the population s represented in these primary -prevention trials . METHODS We developed a Markov model of the cost , quality of life , survival , and incremental cost-effectiveness of the prophylactic implantation of an ICD , as compared with control therapy , among patients with survival and mortality rates similar to those in each of the clinical trials . We modeled the efficacy of the ICD as a reduction in the relative risk of death on the basis of the hazard ratios reported in the individual clinical trials . RESULTS Use of the ICD increased lifetime costs in every trial . Two trials -- the Coronary Artery Bypass Graft ( CABG ) Patch Trial and the Defibrillator in Acute Myocardial Infa rct ion Trial (DINAMIT)--found that the prophylactic implantation of an ICD did not reduce the risk of death and thus was both more expensive and less effective than control therapy . For the other six trials -- the Multicenter Automatic Defibrillator Implantation Trial ( MADIT ) I , MADIT II , the Multicenter Unsustained Tachycardia Trial ( MUSTT ) , the Defibrillators in Non-Ischemic Cardiomyopathy Treatment Evaluation ( DEFINITE ) trial , the Comparison of Medical Therapy , Pacing , and Defibrillation in Heart Failure ( COMPANION ) trial , and the Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT)--the use of an ICD was projected to add between 1.01 and 2.99 quality -adjusted life-years ( QALY ) and between 68,300 dollars and 101,500 dollars in cost . Using base-case assumptions , we found that the cost-effectiveness of the ICD as compared with control therapy in these six population s ranged from 34,000 dollars to 70,200 dollars per QALY gained . Sensitivity analyses showed that this cost-effectiveness ratio would remain below 100,000 dollars per QALY as long as the ICD reduced mortality for seven or more years . CONCLUSIONS Prophylactic implantation of an ICD has a cost-effectiveness ratio below 100,000 dollars per QALY gained in population s in which a significant device-related reduction in mortality has been demonstrated INTRODUCTION Implantable cardioverter defibrillators ( ICDs ) are increasingly being used in high-risk long QT syndrome ( LQTS ) patients , but there are limited data regarding clinical experience with this therapeutic modality . The aim of this study is to describe the clinical characteristics of 125 LQTS patients treated with ICDs compared with LQTS patients having similar risk indications who were not treated with ICDs . Among 125 LQTS patients with ICDs , there were 54 cardiac arrest survivors , 19 patients who had ICDs implanted due to recurrent syncope despite beta-blocker therapy , and 52 patients with ICDs implanted due to other reasons , including syncope and LQTS-related sudden death in a close family member . Patients with cardiac arrest and those with recurrent syncope despite beta-blocker therapy ( n = 73 ) were compared to 161 LQTS patients who had similar indications ( 89 cardiac arrest and 72 recurrent syncope despite beta-blocker therapy ) but did not receive ICDs . Total mortality was the endpoint of the analysis . There was 1 ( 1.3 % ) death in 73 ICD patients followed an average of 3 years , whereas there were 26 deaths ( 16 % ) in non-ICD patients during mean 8-year follow-up ( P = 0.07 from log rank test from Kaplan-Meier curves ) . CONCLUSION ICDs provide an important therapeutic option to prevent sudden arrhythmic death in high-risk LQTS patients . A long-term prospect i ve study is needed to determine the benefit of this therapeutic modality in LQTS patients Background The Long QT Syndrome ( LQTS ) is an infrequently occurring familial disorder in which affected individuals have electrocardiographic QT interval prolongation and a propensity to veiltricular tachyarrhythmic syncope and sudden death . We prospect ively investigated the clinical characteristics and the long-term course of 3,343 individuals from 328 families in which one or more members were identified as affected with LQTS ( QTc > 0.44 sec½ ) . Methods and Results The first member of a family to be identified with LQTS , the prob and , was usually brought to medical attention because of a syncopal episode during childhood or teenage years . Prob and s ( n = 328 ) were younger at first contact ( age 21 ± 15 years ) , more likely to be female ( 69%o ) , and had a higher frequency of preenroilment syncope or cardiac arrest with resuscitation ( 80 % ) , congenital deafness ( 7 % ) , a resting heart rate less than 60 beats/min ( 31 % ) , QTc ≥ 0.50 sec½ ( 52 % ) , and a history of ventricular tachyarrhythmia ( 47 % ) than other affected ( n = 688 ) and unaffected ( n = 1,004 ) family members . Arrhythmogenic syncope often occurred in association with acute physical , emotional , or auditory arousal . The syncopal episodes were frequently misinterpreted as a seizure disorder . By age 12 years , 50 % of the prob and s had experienced at least one syncopal episode or death . The rates of postenrollment syncope ( one or more episodes ) and probable LQTS-related death ( before age 50 years ) for prob and s ( n = 235 ; average follow-up 54 months per patient ) were 5.0 % per year and 0.9 % per year , respectively ; these event rates were considerably higher than those observed among affected and unaffected family members . Conclusions Among 232 prob and s and 1,264 family members with prospect i ve follow-up , three factors made significant independent contributions to the risk of subsequent syncope or probable LQTS-related death before age 50 years , whichever occurred first ( Cox hazard ratio ; 95 % confidence limits ) : 1 ) QTc ( 1.052 ; 1.017 , 1.088 ) , 2 ) history of cardiac event ( 3.1 ; 1.3 , 7.2 ) , and 3 ) heart rate ( 1.017 ; 1.004 , 1.031 ) . The findings from this prospect i ve longitudinal study highlight the clinical features , risk factors , and course of LQTS AIMS To evaluate the effect of beta-blockers in children with long QT syndrome ( LQTS ) we review ed the outcome of 122 patients ( pts ) . METHODS LQTS was diagnosed in 24 neonates and in 98 pts aged 0.5 - 15 years . Diagnosis was made because of syncope in 51 pts , bradycardia in 10 neonates and family history in 61 pts . The longest QTc ranged from 400 to 700 ms . Thirteen pts had 2:1 atrioventricular block and /or ventricular arrhythmias . Screening for mutations was performed in 118 pts . All children were treated with beta-blockers , annually checked by exercise testing and /or 24 h ECG monitoring . RESULTS Four pts died . Survivors were followed-up for 1 - 18 years ( 7.5 + /- 5.3 years ) . Five neonates and 3 older pts received a prophylactic pacemaker ( 1 death ) so that only 111/122 pts survived and were followed-up with beta-blockers alone . None of them died and five experienced a non-fatal cardiac event . There was no cardiac event among pts who were diagnosed because of familial history and among symptomatic KCNQ1 pts who were effectively treated with beta-blockers . CONCLUSION The outcome of children with LQTS under effective beta-blockers is favourable . Persisting arrhythmia or symptoms despite beta-blockers should aim at identifying other genotypes than KCNQ1
Output:
| Among them , genetic testing in the early detection of LQTS was cost-effective compared with no testing in symptomatic cases and not cost-effective when compared with watchful waiting in asymptomatic first-degree relatives of patients with established LQTS although it reached cost-effectiveness in higher risk subgroups , whereas ECG testing in neonates was highly cost-effective when compared with any screening strategy .
LQTS profiling and patients ' stratification have the potential to improve the disease management . |
MS213904 | ***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 Fruit and vegetable consumption is traditionally low in Icel and . The results of the Pro Children cross-Europe survey showed that the consumption was lowest among children in Icel and . The aim of this study was to identify determinants of fruit and vegetable intake among 11-year-old schoolchildren in Icel and . Methods A cross-sectional survey was performed in Icel and in the autumn of 2003 as a part of the Pro Children cross-Europe survey . The survey was design ed to provide information on actual consumption levels of vegetables and fruits by 11-year-old school children and to assess potential determinants of consumption patterns . A total of 1235 Icel and ic children ( 89 % ) from 32 r and omly chosen schools participated . Hierarchical regression analyses were performed to determine the explained variance of the children 's fruit and vegetable intake . In these analyses socio-demographic background variables were entered as a first block , perceived physical-environmental variables as a second block , perceived socio-environmental variables as a third block and personal variables as a fourth block . Results 64 % of the children ate fruit less than once a day , and 61 % ate vegetables less than once a day . Respectively , 31 % and 39 % of the variance in children 's fruit and vegetable intake was explained by the determinants studied . About 7 % and 13 % of the variance in fruit and vegetable intake was explained by the perceived physical-environmental determinants , mainly by availability at home . About 18 % and 16 % of the variance in fruit and vegetable intake was explained by the personal determinants . For both fruit and vegetable intake , the significant personal determinants were preferences , liking , knowledge of recommendations and self-efficacy . Conclusion Interventions to increase fruit and vegetable intake among children should aim at both environmental factors such as greater availability of fruit and vegetables , and personal factors as self-efficacy and knowledge levels concerning nutrition Study objective : To examine associations between food and nutrient intake , measured in childhood , and adult cancer in a cohort with over 60 years follow up . Design and setting : The study is based on the Boyd Orr cohort . Intake of fruit and vegetables , energy , vitamins C and E , carotene , and retinol was assessed from seven day household food inventories carried out during a study of family diet and health in 16 rural and urban areas of Engl and and Scotl and in 1937–39 . Participants : 4999 men and women , from largely working class background s , who had been children in the households participating in the pre-war survey . Analyses are based on 3878 traced subjects with full data on diet and social circumstances . Main results : Over the follow up period there were 483 incident malignant neoplasms . Increased childhood fruit intake was associated with reduced risk of incident cancer . In fully adjusted logistic regression models , odds ratios ( 95 % confidence intervals ) with increasing quartiles of fruit consumption were 1.0 ( reference ) , 0.66 ( 0.48 to 0.90 ) , 0.70 ( 0.51 to 0.97 ) , 0.62 ( 0.43 to 0.90 ) ; p value for linear trend=0.02 . The association was weaker for cancer mortality . There was no clear pattern of association between the other dietary factors and total cancer risk . Conclusions : Childhood fruit consumption may have a long term protective effect on cancer risk in adults . Further prospect i ve studies , with individual measures of diet are required to further eluci date these relations OBJECTIVE Guided by theory , this study explored cross-sectional differences in factors influencing adolescent eating behaviour including gender and socio-economic status ( SES ) , and subsequently tested the longitudinal predictive power of the models . DESIGN / SETTING /SUBJECTS Data were collected by question naires in a longitudinal study of adolescents ( age 13 years at baseline ) and their parents from Hordal and County , Norway . Association of personal and environmental variables ( family , friends , school/society ) with the consumption of fruit and vegetables ( FV ) and selected sources of fat and of sugar were assessed at age 15 The final cross-sectional models were subsequently employed in groups stratified by gender/SES and to predict consumption at age 21 RESULTS The model explained more of the variation in the sugar score ( 21 % ) and the FV score ( 13.5 % ) than in the fat score ( 5 % ) . SES was associated with both the sugar and FV scores . The strongest associations with the sugar score and FV were for antisocial behaviour and evaluation of own diet , respectively . The former association was significant in all gender/SES groups , whereas the latter association was only significant in the low SES groups . For all three types of food , the strongest significant predictors in the longitudinal models were frequency of consumption at age 15 . CONCLUSION The model 's ability to explain variation in eating behaviours differed by food type , and possibly by gender/SES , but previous eating behaviour was an important predictor for all three foods . Prospect i ve studies should carefully operationalize theoretical constructs when further investigating the influences of and interrelationships between these factors and gender/SES on the development of eating behaviours Objective : The present study aim ed at investigating the influence of food availability , rules and television viewing habits on eating behaviours in adolescents . Design : Cross-sectional study . Setting : Four r and omly selected middle schools . Subjects : A sample of 534 seventh and eighth grade rs . Interventions : Vali date d question naires were used to measure the family environment and fat , soft drink and fruit consumption . Hierarchical regression analyses on fat , soft drink and fruit consumption , with demographic and psychosocial variables entered as the first and environmental factors as the second block were conducted in boys and girls . Results : Boys with more unhealthy products available at home consumed more fat ( P⩽0.001 , 95 % CI : 8.2–29.4 ) and more soft drinks ( P⩽0.01 , 95 % CI : 0.2–1.4 ) . Boys who reported better television viewing habits ate more fruit ( P⩽0.001 , 95 % CI : −1.7 to −0.5 ) . Girls who reported better television viewing habits consumed less fat ( P⩽0.01 , 95 % CI : 1.4–9.0 ) and more fruit ( P⩽0.05 , 95 % CI : −1.0 to −0.1 ) . Girls who reported higher availability of healthy products at home ( P⩽0.05 , 95 % CI : 0.3–3.1 ) and more food rules ( P⩽0.001 , 95 % CI : −1.8 to −0.5 ) , consumed more fruit . Environmental factors were poor predictors of soft drink consumption among girls . Conclusion : Availability of (un)healthy food products , family food rules and TV viewing habits were related to one or more eating behaviours in boys or girls . Although home environmental factors can play an important role in influencing adolescents ’ eating behaviours , these factors were generally less predictive than demographic and psychosocial variables . Sponsorship : Ghent University and Policy Research Centre Sport , Physical Activity and Health funded by the Flemish Government Background The first aim of the present study was to investigate differences in correlates of vegetable intake between the normal weight and the overweight boys in the Pro Children Cross Sectional Study . The second aim was to explore whether the association between vegetable intake and potential correlates is different in overweight boys compared with normal weight boys . Methods R and om sample s of mainly 11-year old children were recruited in 9 European countries . The total sample size consisted of 3960 boys ( 16.5 % overweight ) . A vali date d self-report question naire was used to measure vegetable intake , and personal , social and environmental factors related to vegetable intake in the classroom . Weight and height were reported by the parents of the children in parents ' question naires . Results Regression analyses explained 23 % to 28 % of the variance in vegetable intake by potential correlates . Liking , self-efficacy and bringing vegetables to school were related to intake in both normal weight and overweight boys ( β's>0.10 ) . Active parental encouragement and availability at home was only related to intake in overweight boys ( β's>0.10 ) , whereas knowledge about recommendations was only related to vegetable consumption in normal weight boys ( β>0.10 ) Conclusion Intervention strategies to increase vegetable intake should focus on increase in liking and preferences , increase in self-efficacy , and increase in bringing vegetables to school in both normal weight and overweight boys . Further research should investigate whether advising parents of overweight boys to encourage their child to eat vegetables every day , to insist as far as possible that their child eats vegetables regularly and to make vegetables easily available at home is effective in changing vegetable intake OBJECTIVE This paper identifies the anthropometric , parental , and psychosocial characteristics and meal practice s ( e.g. , breakfast skipping and number of meals and snacks consumed ) associated with consumption of total energy , percent energy from fat , fruit , 100 % fruit juice , vegetables , sweetened beverages , and water among 8- to 10-year-old African-American girls . RESEARCH METHODS AND PROCEDURES This study included 114 8- to 10-year-old African-American girls and a parent or primary caregiver . Girls and a parent or primary caregiver completed several dietary question naires . Two 24-hour dietary recalls were conducted with each girl . Height and weight were measured . Separate hierarchical regression analyses were conducted for each dependent dietary variable ; potential field center differences were examined . RESULTS The number of meals and snacks consumed was correlated with energy intake . Lower BMI was related to higher vegetable consumption , and the number of snacks consumed was positively related to sweetened beverage consumption . Greater low-fat food preparation practice s reported by parents were related to lower consumption of fat as a percentage of total energy . DISCUSSION Dietary behavior differed across geographic areas . Low-fat food preparation practice s in the home seemed to be an important influence on the percentage of energy consumed from fat . Greater vegetable consumption was associated with lower BMI . Interventions to prevent excessive weight gain in African-American girls should encourage low-fat food preparation in the home and greater consumption of vegetables OBJECTIVE To determine factors associated with the consumption of fruit and vegetables among 11-year-old schoolchildren in Belgium-Fl and ers and the Netherl and s. DESIGN In total , 2468 school children from 98 r and omly selected schools participated in a cross-sectional survey . VARIABLES MEASURED Frequency of fruit and vegetable intake and potential personal , social and environmental correlates were measured by means of self-administered , school-based , written question naires . ANALYSIS Hierarchical multiple regression analyses were conducted to assess potential correlates of schoolchildren 's fruit and vegetable consumption . Separate analyses were conducted for boys and girls . RESULTS Bringing fruit to school , modeling behavior of parents and friends , parents dem and ing that their child eat fruit , knowledge about recommended intake levels , liking fruit , and self-efficacy to eat fruit were the strongest correlates of fruit intake . For vegetables , gender , parental dem and , parents facilitating the consumption of vegetables by cutting them for their child , modeling behavior of parents and friends , and preferences for vegetables emerged as strongest correlates . No substantial differences in significant correlates were found according to gender . The percentage of explained variance was 33.7 % for fruit and 28.4 % for vegetable intake . CONCLUSIONS Interventions need to be focused on personal ( taste preferences ) , social ( parental influences ) , and environmental factors ( availability ) OBJECTIVE To examine socio-demographic correlates of dietary habits at 15 and 18 years . DESIGN First and second sweeps of a longitudinal survey , based on a two-stage stratified clustered r and om sample . SETTING Central Clydeside Conurbation , in the West of Scotl and . SUBJECTS A r and om sample of 1682 households containing 15-year-olds was approached by Strathclyde Regional Council , 70 % of whom agreed to have their names passed on to the MRC . 1009 ( 86 % ) of this target sample were interviewed at baseline . 908 ( 90 % ) were re-interviewed at age 18 . Analyses are restricted to respondents who took part in both data collection sweeps . MEASURES Questions on meal patterns and food choices were included in the interviews : self-complete question naires included a dietary inventory . Social class was measured by reference to the head of household at baseline : information on own labour market position and place of residence was obtained at 18 . RESULTS At 18 there was clear differentiation in food choices and meal patterns according to sex and both parental social class and own current labour market position . Controlling for class , dietary habits at 15 were independently related to future labour market position . Overall changes in eating habits between 15 and 18 were slight , though females were more likely to have increased consumption of foods consistent with current recommendations , while the un/non-employed reduced their consumption of a midday meal . CONCLUSIONS Dietary habits are established in mid-teens and closely associated with lifestyle , facts which need to be taken into consideration in design ing effective nutrition education programmes OBJECTIVES To examine the food patterns and diet quality of elementary schoolchildren in New York State ( outside of New York City ) and to determine sociodemographic characteristics correlated with diet quality . DESIGN A nonquantitative 24-hour recall administered to students and a brief question naire completed by parents . SAMPLE 1,797 second and fifth grade rs ( 51 % of those asked ) in 51 r and omly selected schools ( 46 % of those asked ) in New York State outside of New York City . STATISTICAL ANALYSES Multiple regression analyses , chi 2 , and t tests
Output:
| RESULTS Parental modelling and parental intake were consistently and positively associated with children 's fruit and fruit , juice and vegetable ( FJV ) consumption .
There were also positive associations between home availability , family rules and parental encouragement and children 's fruit and vegetable consumption .
Parental intake was positively associated with adolescents ' fruit and vegetable consumption .
There were also positive associations between parental occupational status and adolescent fruit consumption and between parental education and adolescents ' FJV consumption . |
MS213905 | ***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 investigate the effects of simultaneous explosive-strength and endurance training on physical performance characteristics , 10 experimental ( E ) and 8 control ( C ) endurance athletes trained for 9 wk . The total training volume was kept the same in both groups , but 32 % of training in E and 3 % in C was replaced by explosive-type strength training . A 5-km time trial ( 5 K ) , running economy ( RE ) , maximal 20-m speed ( V20 m ) , and 5-jump ( 5J ) tests were measured on a track . Maximal anaerobic ( MART ) and aerobic treadmill running tests were used to determine maximal velocity in the MART ( VMART ) and maximal oxygen uptake ( VO2 max ) . The 5 K time , RE , and VMART improved ( P < 0.05 ) in E , but no changes were observed in C. V20 m and 5J increased in E ( P < 0.01 ) and decreased in C ( P < 0.05 ) . VO2 max increased in C ( P < 0.05 ) , but no changes were observed in E. In the pooled data , the changes in the 5 K velocity during 9 wk of training correlated ( P < 0.05 ) with the changes in RE [ O2 uptake ( r = -0.54 ) ] and VMART ( r = 0.55 ) . In conclusion , the present simultaneous explosive-strength and endurance training improved the 5 K time in well-trained endurance athletes without changes in their VO2 max . This improvement was due to improved neuromuscular characteristics that were transferred into improved VMART and running economy Fifteen highly trained distance runners ( & OV0312;O2max 71.1 ± 6.0 ml·min−1·kg−1 , mean ± SD ) were r and omly assigned to a plyometric training ( PLY ; n = 7 ) or control ( CON ; n = 8) group . In addition to their normal training , the PLY group undertook 3 × 30 minutes PLY sessions per week for 9 weeks . Running economy ( RE ) was assessed during 3 × 4 minute treadmill runs ( 14 , 16 , and 18 km·h−1 ) , followed by an incremental test to measure & OV0312;O2max . Muscle power characteristics were assessed on a portable , unidirectional ground reaction force plate . Compared with CON , PLY improved RE at 18 km·h−1 ( 4.1 % , p = 0.02 ) , but not at 14 or 16 km·h−1 . This was accompanied by trends for increased average power during a 5-jump plyometric test ( 15 % , p = 0.11 ) , a shorter time to reach maximal dynamic strength during a strength quality assessment test ( 14 % , p = 0.09 ) , and a lower & OV0312;O2-speed slope ( 14 % , p = 0.12 ) after 9 weeks of PLY . There were no significant differences in cardiorespiratory measures or & OV0312;O2max as a result of PLY . In a group of highly-trained distance runners , 9 weeks of PLY improved RE , with likely mechanisms residing in the muscle , or alternatively by improving running mechanics Abstract The purpose of this study was to investigate the effect of concurrent strength and endurance training on strength , endurance , endocrine status and muscle fibre properties . A total of 45 male and female subjects were r and omly assigned to one of four groups ; strength training only ( S ) , endurance training only ( E ) , concurrent strength and endurance training ( SE ) , or a control group ( C ) . Groups S and E trained 3 days a week and the SE group trained 6 days a week for 12 weeks . Tests were made before and after 6 and 12 weeks of training . There was a similar increase in maximal oxygen consumption ( V˙O2max ) in both groups E and SE ( P < 0.05 ) . Leg press and knee extension one repetition maximum ( 1 RM ) was increased in groups S and SE ( P < 0.05 ) but the gains in knee extension 1 RM were greater for group S compared to all other groups ( P < 0.05 ) . Types I and II muscle fibre area increased after 6 and 12 weeks of strength training and after 12 weeks of combined training in type II fibres only ( P < 0.05 ) . Groups SE and E had an increase in succinate dehydrogenase activity and group E had a decrease in adenosine triphosphatase after 12 weeks of training ( P < 0.05 ) . A significant increase in capillary per fibre ratio was noted after 12 weeks of training in group SE . No changes were observed in testosterone , human growth hormone or sex hormone binding globulin concentrations for any group but there was a greater urinary cortisol concentration in the women of group SE and decrease in the men of group E after 12 weeks of training ( P < 0.05 ) . These findings would support the contention that combined strength and endurance training can suppress some of the adaptations to strength training and augment some aspects of capillarization in skeletal muscle The purpose of this study was to investigate effects of concurrent strength and endurance training ( SE ) ( 2 plus 2 days a week ) versus strength training only ( S ) ( 2 days a week ) in men [ SE : n=11 ; 38 ( 5 ) years , S : n=16 ; 37 ( 5 ) years ] over a training period of 21 weeks . The resistance training program addressed both maximal and explosive strength components . EMG , maximal isometric force , 1 RM strength , and rate of force development ( RFD ) of the leg extensors , muscle cross-sectional area ( CSA ) of the quadriceps femoris ( QF ) throughout the lengths of 4/15–12/15 ( Lf ) of the femur , muscle fibre proportion and areas of types I , IIa , and IIb of the vastus lateralis ( VL ) , and maximal oxygen uptake ( V̇O2max ) were evaluated . No changes occurred in strength during the 1-week control period , while after the 21-week training period increases of 21 % ( p<0.001 ) and 22 % ( p<0.001 ) , and of 22 % ( p<0.001 ) and 21 % ( p<0.001 ) took place in the 1RM load and maximal isometric force in S and SE , respectively . Increases of 26 % ( p<0.05 ) and 29 % ( p<0.001 ) occurred in the maximum iEMG of the VL in S and SE , respectively . The CSA of the QF increased throughout the length of the QF ( from 4/15 to 12/15 Lf ) both in S ( p<0.05–0.001 ) and SE ( p<0.01–0.001 ) . The mean fibre areas of types I , IIa and IIb increased after the training both in S ( p<0.05 and 0.01 ) and SE ( p<0.05 and p<0.01 ) . S showed an increase in RFD ( p<0.01 ) , while no change occurred in SE . The average iEMG of the VL during the first 500 ms of the rapid isometric action increased ( p<0.05–0.001 ) only in S. V̇O2max increased by 18.5 % ( p<0.001 ) in SE . The present data do not support the concept of the universal nature of the interference effect in strength development and muscle hypertrophy when strength training is performed concurrently with endurance training , and the training volume is diluted by a longer period of time with a low frequency of training . However , the present results suggest that even the low-frequency concurrent strength and endurance training leads to interference in explosive strength development mediated in part by the limitations of rapid voluntary neural activation of the trained muscles 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 The purpose of this study was to compare the physiologic effects of a program of combined running and weight training ( RUN-CWT ) with a program of circuit weight training ( CWT ) . Thirty-six females ( X age = 35.7 yr ) and 41 males ( X age = 36.1 yr ) were r and omly assigned to RUN-CWT , CWT , and control groups . The training groups participated in 12-wk programs , 3 d . wk-1 . Three circuits of 10 weight-training exercises were completed with 12 - 15 repetitions performed in 30 s at 40 % of one-repetition maximum at each station . The 30-min RUN-CWT program included 30 s of running on an indoor track following each CWT station , whereas the 22.5 min CWT program included a 15-s rest period between stations . The RUN-CWT groups had a significant ( + 17 % ) increase in VO2max ( females 30.5 - 35.7 ml . kg-1 . min-1 and males 39.7 - 46.3 ml . kg-1 . min-1 ) and strength ( females + 24 % and males + 21 % ) , and a significant decrease in body fat percentage ( females -3.2 % and males -4.1 % ) . The CWT groups also increased significantly in VO2max ( + 12 % ) and strength ( + 17 % ) and decreased in body fat ( -3.0 % ) . The controls did not change significantly in any variable . Statistically , one training program was not shown to be superior to the other ; thus , both programs of RUN-CWT and CWT were effective in improving measures of physical fitness PURPOSE It has been suggested that endurance training influences the running economy ( CR ) and the oxygen uptake ( .VO(2 ) ) kinetics in heavy exercise by accelerating the primary phase and attenuating the .VO(2 ) slow component . However , the effects of heavy weight training ( HWT ) in combination with endurance training remain unclear . The purpose of this study was to examine the influence of a concurrent HWT+endurance training on CR and the .VO(2 ) kinetics in endurance athletes . METHODS Fifteen triathletes were assigned to endurance+strength ( ES ) or endurance-only ( E ) training for 14 wk . The training program was similar , except ES performed two HWT sessions a week . Before and after the training period , the subjects performed 1 ) an incremental field running test for determination of .VO(2max ) and the velocity associated ( V(.VO2max ) ) , the second ventilatory threshold ( VT(2 ) ) ; 2 ) a 3000-m run at constant velocity , calculated to require 25 % of the difference between .VO(2max ) and VT(2 ) , to determine CR and the characteristics of the VO(2 ) kinetics ; 3 ) maximal hopping tests to determine maximal mechanical power and lower-limb stiffness ; 4 ) maximal concentric lower-limb strength measurements . RESULTS After the training period , maximal strength were increased ( P < 0.01 ) in ES but remained unchanged in E. Hopping power decreased in E ( P < 0.05 ) . After training , economy ( P < 0.05 ) and hopping power ( P < 0.001 ) were greater in ES than in E. .VO(2max ) , leg hopping stiffness and the .VO(2 ) kinetics were not significantly affected by training either in ES or E. CONCLUSION Additional HWT led to improved maximal strength and running economy with no significant effects on the .VO(2 ) kinetics pattern in heavy exercise The purpose of this research was to determine the effects of high intensity endurance training ( ET ) and resistance training ( RT ) alone and in combination on various military tasks . Thirty-five male soldiers were r and omly assigned to one of four training groups : total body resistance training plus endurance training ( RT + ET ) , upper body resistance training plus endurance training [ UB + ET ) , RT only , and ET only . Training was performed 4 days per week for 12 weeks . Testing occurred before and after the 12-week training regimen . All groups significantly improved push-up performance , whereas only the RT + ET group did not improve sit-up performance . The groups that included ET significantly decreased 2-mile run time , however , only RT + ET and UB + ET showed improved loaded 2-mile run time . Leg power increased for groups that included lower body strengthening exercises ( RT and RT + ET ) . Army Physical Fitness Test performance , loaded running , and leg power responded positively to training , however , it appears there is a high degree of specificity when concurrent training regimens are implemented The aim of this experiment was to examine the effects of maximal strength training with emphasis on neural adaptations on strength- and
Output:
| After critically review ing the literature for the impact of CT on high-level runners , we conclude that resistance training likely has a positive effect on endurance running performance or RE . |
MS213906 | ***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: In the last years pre clinical studies have paved the way for the use of adult muscle derived stem cells for reconstruction of the lower urinary tract . Between September 2002 and October 2004 , 42 women and 21 men suffering from urinary stress incontinence ( age 36 - 84 years ) were recruited and subsequently treated with transurethral ultrasonography-guided injections of autologous myoblasts and fibroblasts obtained from skeletal muscle biopsies . The fibroblasts were injected into the urethral submucosa , while the myoblasts were implanted into the rhabdosphincter . In parallel , 7 men and 21 women ( age 39 - 83 years ) also diagnosed with urinary stress incontinence were treated with st and ard transurethral endoscopic injections of collagen . Patients were r and omly assigned to both groups . After a follow-up of 12 months incontinence was cured in 39 women and 11 men after injection of autologous myoblasts and fibroblasts . Mean quality of life score ( 51.38 preoperatively , 104.06 postoperatively ) , thickness of urethra and rhabdosphincter ( 2.103 mm preoperatively , 3.303 mm postoperatively ) as well as contractility of the rhabdosphincter ( 0.56 mm preoperatively , 1.462 mm postoperatively ) were improved postoperatively . Only in two patients treated with injections of collagen incontinence was cured . The present clinical results demonstrate that , in contrast to injections of collagen , urinary incontinence can be treated effectively with ultrasonography-guided injections of autologous myo- and fibroblasts Purpose : To compare short-term results of autologous pubovaginal sling and synthetic transobturator ( TOT ) SAFYRE sling in the treatment of female stress urinary incontinence ( SUI ) . Methods : Twenty women referred for surgical treatment of SUI were assigned r and omly to autologous pubovaginal sling or synthetic TOT sling . Inclusion criteria were primary treatment of SUI and urodynamic study showing SUI without detrusor overactivity . Pre- and postoperative quantification of the severity of incontinence was done by pad test and a vali date d question naire ( King ’s Health Question naire ) . Results : There were no differences in patients ’ mean age , parity , body mass index , rate of postmenopausal state , pelvic floor defects and mean Valsalva leak point pressure in the preoperative urodynamic study . Mean operating time ( 21.1 ± 3.8 vs. 69.5 ± 23.7 min ; P<0.001 ) and hospital stay ( 28.8 ± 8.4 vs. 44.4 ± 5.8 h ; P<0.001 ) was shorter in the TOT than the autologous group . The postoperative pad test ( 39.4 ± 12.5 vs. 8.4 ± 5.2 g ; P=0.01 ) and the absent in the improvement in the quality of life were significantly higher in the TOT group . Conclusion : Our initial results suggest that the synthetic TOT technique had worse effectiveness for treating female SUI compared to autologous pubovaginal sling OBJECTIVE To assess the feasibility and safety of ultrasound-guided autologous myoblast injections into the external urethral sphincter followed by electrical stimulation ( ES ) as a possible 2-step treatment for stress urinary incontinence ( SUI ) . METHODS Autologous myoblasts isolated from a biceps muscle sample were injected under transurethral ultrasound guidance into the external urethral sphincter of 38 female patients . The patients also underwent ES postoperatively to enhance cell integration . Treatment feasibility , as well as possible intraoperative and postoperative complications , was assessed 6weeks after the injections . Additionally , the effects of the myoblast injections followed by an ES cycle were compared to those of a preoperative ES cycle undergone by the same patients . RESULTS No serious adverse events or complications were noted and the procedure was well tolerated . Compared with the objective and subjective measurements collected after the preoperative ES cycle , the corresponding measurements obtained 6weeks postoperatively , after the completion of a second ES cycle , indicated considerable improvement . The results to the stress test were negative for 29 ( 78.4 % ) of the patients , 5 ( 13.5 % ) considered their SUI cured , and 29 ( 78.4 % ) reported improvement . CONCLUSION Intrasphincteric autologous myoblast injections followed by ES is minimally invasive and feasible , and safely produced promising initial results . EU Clinical Trials EudraCT No. 2009 - 012389 - 30 Clinical Trials.gov identifier : NCT01355133 Introduction and hypothesisCell therapy for stress urinary incontinence ( SUI ) management has been experienced with encouraging results . Methods We conducted an open prospect i ve study on 12 women presenting severe SUI with fixed urethra , after previous failed surgical management . Patients underwent intrasphincteric injections of autologous progenitor muscular cells isolated from a biopsy of deltoid muscle . Primary endpoint focused on safety ( measurement of Qmax variation after 3 months ) . Secondary endpoints assessed side effects and efficacy . Results No variation was diagnosed on Qmax measurements . Efficacy data show that three of 12 patients are dry at 12 months , seven other patients are improved on pad test but not on voiding diary , and two patients were slightly worsened by the procedure . Quality of life was improved in half of patients . Conclusions Cell therapy for severe multioperated cases of SUI is a mini-invasive , feasible , and safe procedure that can improve urinary condition in as a second line therapy Objective . To evaluate long-term effectiveness and safety of conservative and minimally invasive outpatient treatments for female stress urinary incontinence ( SUI ) through a review of the literature . Methods . PubMed was search ed for reports on prospect i ve clinical trials with at least 12-month follow-up of minimally invasive treatments , pelvic floor rehabilitation , or pharmacotherapy in women with SUI . Each report was examined for long-term rates of effectiveness and safety . Results . Thirty-two clinical trial reports were included . Prospect i ve long-term studies of pelvic floor rehabilitation were limited but indicated significant improvements with treatment adherence for at least 12 months . Poor initial tolerability with duloxetine result ed in substantial discontinuation . Most patients receiving transurethral radiofrequency collagen denaturation or urethral bulking agents reported significant long-term improvements , generally good tolerability , and safety . Conclusions . Conservative therapy is an appropriate initial approach for female SUI , but if therapy fails , radiofrequency collagen denaturation or bulking agents may be an attractive intermediate management step or alternative to surgery OBJECTIVE This study was undertaken to compare tension-free vaginal tape ( TVT ) with colposuspension as the primary treatment for stress incontinence . STUDY DESIGN The trial was conducted in gynecology or urology departments in 14 centers in the United Kingdom and Irel and . Three hundred forty-four women with urodynamic stress incontinence were r and omly assigned to groups : 175 to TVT and 169 to colposuspension . Patients were assessed using the Short Form-36 health status question naire , the Bristol Female Lower Urinary Tract Symptoms question naire , clinical examination , and a 1-hour perineal pad test . Unpaired and paired data were analyzed with the Wilcoxon rank sum and matched pairs tests , respectively , and proportions were compared with the Fisher exact test . RESULTS When data were analyzed on an intention-to-treat basis , assuming patients with missing data to be treatment failures , 63 % of the TVT group and 51 % of the colposuspension group were objective ly cured at 2 years ( odds ratio 1.67 , 95 % CI 1.09 - 2.58 ) . CONCLUSION The TVT procedure appears to be as effective as colposuspension for the treatment of urodynamic stress incontinence at 2 years We hereby report a 1-year follow-up on eight women in the first North America trial in which stress urinary incontinence ( SUI ) was treated with muscle-derived stem cell injections . Mean and median follow-up in this group was 16.5 and 17 months ( range 3–24 months ) . Improvement in SUI was seen in five of eight women , with one achieving total continence . Onset of improvement was between 3 and 8 months after injection . Cure or improvement continued at a median of 10 months . No serious adverse events were reported To assess the maintenance of efficacy of duloxetine beyond 3 months , using data from several long‐term , open‐label studies , as the efficacy of duloxetine 40‐mg twice daily for treating women with stress urinary incontinence ( SUI ) for up to 3 months has been established in several r and omized , placebo‐controlled clinical trials
Output:
| Conclusion Data suggest that SC treatment for SUI is safe and effective in the short term . |
MS213907 | ***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 Patient aggression is a common problem in acute psychiatric wards and calls for preventive measures . The timely use of preventive measures presupposes a preceded risk assessment . The Norwegian Brøset-Violence-Checklist ( BVC ) is one of the few instruments suited for short-time prediction of violence of psychiatric in patients in routine care . Aims of our study were to improve the accuracy of the short-term prediction of violence in acute inpatient setting s by combining the Brøset-Violence-Checklist ( BVC ) with an overall subjective clinical risk- assessment and to test the application of the combined measure in daily practice . Method We conducted a prospect i ve cohort study with two sample s of newly admitted psychiatric patients for instrument development ( 219 patients ) and clinical application ( 300 patients ) . Risk of physical attacks was assessed by combining the 6-item BVC and a 6-point score derived from a Visual Analog Scale . Incidents were registered with the Staff Observation of Aggression Scale-Revised SOAS-R. Test accuracy was described as the area under the receiver operating characteristic curve ( AUCROC ) . Results The AUCROC of the new VAS-complemented BVC-version ( BVC-VAS ) was 0.95 in and 0.89 in the derivation and validation study respectively . Conclusion The BVC-VAS is an easy to use and accurate instrument for systematic short-term prediction of violent attacks in acute psychiatric wards . The inclusion of the VAS-derived data did not change the accuracy of the original BVC Positive psychotic symptoms , such as threat/"control-override " delusions or comm and hallucinations , have been related to aggression in patients with schizophrenia . However , retrospective data collection has hampered evaluation of the direct influence of psychopathology on aggressive behavior . In this study , we monitored aggressive behavior and psychopathology prospect ively and in close temporal proximity in 157 treatment-resistant in patients diagnosed with chronic schizophrenia or schizoaffective disorder participating in a 14-week double-blind clinical trial . Aggressive behavior was rated with the overt aggression scale ( OAS ) . Psychopathology was assessed using the positive and negative syndrome scale ( PANSS ) . At baseline , subjects who would be aggressive during the study had higher scores on only two PANSS items : hostility and poor impulse control . During the study PANSS positive subscale scores were significantly higher in aggressive subjects . Total PANSS scores were higher within 3 days of an aggressive incident , as were positive and general psychopathology subscale scores . However , in a smaller sub sample for whom PANSS ratings were available within 3 days before aggressive incidents , only scores on the PANSS positive subscale were significantly higher . These findings in chronic , treatment resistant in patients support the view that positive symptoms may lead to aggression Objective : This study examined the predictive validity of the German translation of the Psychopathy Checklist-Screening Version ( PCL-SV ) for negative events during the course of the prison sentence of German prisoners . Method : Using the PCL-SV , we investigated 145 offenders in a German prison at the start of their sentences . We then compared the extreme groups identified by the PCL-SV — the high and low scorers — using a prospect i ve design with respect to negative events and factors during the course of the sentences . This involved the st and ardized collection of data on both objective records of disciplinary incidents and subjective impressions from prison staff on the basis of operationalized criteria . Results : The high scorers were involved in significantly more disciplinary incidents and were also rated significantly less favourably by prison staff than the low scorers . Conclusion : Until now , the PCL has only been shown to predict recidivism following release from prison . The results of our study show that the PCL also has predictive validity for problems during the course of the sentence . It is therefore recommended that the PCL be used routinely at the start of the prison sentence to estimate the likelihood of subsequent difficulties If clinicians in forensic psychiatry want to reduce risk of reoffending in their patients , they require insight into dynamic risk factors , and evidence that these add predictive power to static risk indicators . Predictors need to be evaluated under clinical ly realistic circumstances . This study aim ed to vali date dynamic and static variables as predictors of reconviction in a naturalistic outcome study . Data on static and dynamic risk factors were collected for 151 patients discharged from Dutch forensic psychiatric hospitals . Community follow-up was prospect i ve , with a 5.5 year minimum . A prediction model was developed using Cox regression analysis . The magnitude of the predictive power of this model was estimated using receiver operating characteristic ( ROC ) analysis . The final prediction model contained four static and no dynamic predictors . The model 's ROC area under the curve was .79 ( 95 % CI .69–.89 ) . Clinical risk ratings were non-predictive . Post hoc analyses exploring the influence of subgroups of patients did not yield better models . It is concluded that a small set of static predictors yielded a good estimate of future reconvictions ; inclusion of dynamic predictors did not add predictive power OBJECTIVE Outward-directed violence and impulsivity in humans and primates has frequently been related to abnormal brain monoaminergic turnover . Self-rated aggression is likely to be clinical ly relevant , and its psychobiological basis needs investigation . SUBJECTS Sixty-six patients ( 40 women and 26 men ) with persistent depressive disorder ( PDD ) were compared with 497 control subjects from the general Swedish population . METHODS We administered the Aggression Question naire - Revised Swedish Version ( AQ-RSV ) to patients and control subjects . In patients , CSF 5-hydroxyindoleacetic acid ( 5-HIAA ) and 3-methoxy-5-hydroxyphenylglycol ( MHPG ) in CSF were analyzed . Total Aggression score and Aggression subfactors ' Physical Aggression','Verbal Aggression','Anger ' , and ' Hostility'were correlated with CSF concentrations of 5-hydroxyindoleacetic acid ( 5-HIAA ) , and 3-methoxy-5-hydroxyphenylglycol ( MHPG ) . RESULTS Overall , Hostility was positively related to CSF MHPG ( t=2.27 , p=0.015 ) . Split by sex , Hostility was related with 5-HIAA in males ( r=0.62,p=0.003 ) , and with MHPG in females ( r=0.38 , p=0.03 ) . Comparing self rated aggression with age- and sex-matched data from the general Swedish population , the most prominent deviation was increased Hostility score among PDD patients . Among patients , all aggression factors were nominally higher in women than in men , with the most pronounced sex difference in Hostility ( t=-1.89 , p=0.04 ) . CONCLUSIONS Results suggest a clinical ly meaningful sex difference in a positive relationship between hostility and serotonergic/noradrenergic turnover in PDD patients BACKGROUND A critical step for improving the prediction of on-ward violence is the identification of variables that are not only consistently associated with an increased risk of aggression but also easily evaluated during the admission interview . The goal of this prospect i ve study was to assess the predictive utility of hostility during admission interview . METHOD The sample consisted of 80 newly admitted male patients with heterogeneous DSM-IV psychiatric diagnoses recruited from the psychiatric ward of an urban public hospital . Psychiatric symptoms at admission were assessed with the Brief Psychiatric Rating Scale ( BPRS ) . Aggressive behavior during the first week of hospitalization was measured with the Modified Overt Aggression Scale . Data were collected between January and June 1998 . RESULTS In a multiple regression model , BPRS items hostility and tension-excitement emerged as significant predictors of verbal aggression , whereas thinking disturbance ( high ) and suspiciousness-uncooperativeness ( low ) emerged as significant predictors of aggression against objects . In contrast , when aggression was treated as a binary dependent variable in a logistic model , hostility during the admission interview had no utility in predicting on-ward aggressive behavior . CONCLUSION This study confirms the importance of distinguishing between different types of aggression to improve the accuracy of predictions of violence . The findings suggest that the question whether hostility is a useful short-term predictor of aggression in psychiatric in patients can not be answered conclusively . The predictive utility of hostility was relatively high for predicting verbal aggression but was negligible for predicting other types of aggressive behavior BACKGROUND Risk assessment of future violent acts is of great importance for both public protection and care planning . Structured clinical assessment s offer a method by which accurate assessment s could be achieved . AIMS To test the efficacy of the Historical , Clinical and Risk Management Scales ( HCR-20 ) structured risk assessment scheme on a large sample of male forensic psychiatric patients discharged from medium secure units in the UK . METHOD In a pseudo- prospect i ve study , 887 male patients were followed for at least 2 years . The HCR-20 was completed using only pre-discharge information , and violent and other offending behaviour post-discharge was obtained from official records . RESULTS The HCR-20 total score was a good predictor of both violent and other offences following discharge . The historical and risk sub-scales were both able to predict offences , but the clinical sub-scale did not produce significant predictions . The predictive efficacy was highest for short periods ( under 1 year ) and showed a modest fall in efficacy over longer periods ( 5 years ) . CONCLUSIONS The results provide a strong evidence base that the HCR-20 is a good predictor of both violent and non-violent offending following release from medium secure units for male forensic psychiatric patients in the UK The author investigated the acute effects of alcohol intoxication on anger experience and expression among 46 maritally violent ( MV ) and 56 maritally nonviolent ( NV ) men r and omly assigned to receive alcohol , placebo , or no alcohol . Participants completed an anger-arousing articulated thoughts in simulated situations ( ATSS ) paradigm and imagined marital conflict scenarios . Anger experience was operationalized as subjective ratings of anger experienced during ATSS , and anger expression was measured as ATSS anger statements and aggression verbalizations . MV men given alcohol articulated significantly more aggressive verbalizations than all other groups , with high trait anger and increased anger experience predicting more aggressive verbalizations . Thus , alcohol may exert proximal effects on abusive behavior among individuals already prone to respond to conflict with increased anger This study evaluated the predictive validity of violence risk assessment s conducted using the HCR-20 , the Psychopathy Checklist : Screening Version ( PCL : SV ) , and by the Violence Screening Checklist ( VSC ) in a sample of 268 involuntarily hospitalized male and female psychiatric patients . Information pertaining to violence and crime was coded from medical charts and correctional records . The HCR-20/PCL : SV evidence d modest non-significant associations in postdictive assessment s of inpatient violence among men . Moderate to strong significant associations were found between the HCR-20/PCL : SV and inpatient violence among women . Pseudo- prospect i ve assessment s using the HCR-20 and PCL : SV result ed in moderate to large relationships with violence and crime in men and women following community discharge . It is concluded that the VSC is a promising tool for assessing acute inpatient violence risk with men . Findings offer preliminary validation of the predictive validity of the HCR-20 and PCL : SV with female civil psychiatric patients Prospect i ve longitudinal studies have shown strong predictions from conduct disorders ( CDs ) in childhood to antisocial personality disorder ( ASPD ) and violence in adults . However , little is known of the childhood antecedents of serious violence nor whether these may vary depending on the context in which the violence occurs . In this study , 54 men aged 21 - 40 years serving prison sentences for violent crime were assessed . St and ardized interviews of ASPD and violence were conducted independently of interviews covering retrospective recall of childhood psychiatric disorders and adverse experiences . Analyses of the predictors of overall violence suggested a pathway involving childhood CD and adult ASPD associated with interparental discord , and an additional pathway associated with experiencing interparental violence in childhood . Different results were however obtained when account was taken of the context of the violence . The CD-ASPD pathway was associated with social violence , but not with partner violence . Partner violence was predicted by retrospective reports of having been exposed to interparental violence during childhood but not by reports of childhood CD or adult ASPD . Thus developmental pathways to serious violence may be different depending on the social domain in which the violence occurs This prospect i ve study explores the predictive value of insight for suicide , violence , hospitalization , and social adjustment for a group of schizophrenic out patients over 1 year . The Schedule of Assessment of Insight ( SAI ) and its exp and ed version ( SAI-E ) were used to provide a baseline insight score for 74 schizophrenic out patients considered to be in remission or to have minimal psychopathology . Subjects were reassessed at the end of the period to determine the predictive value of initial insight rating by comparison . Insight into treatment was associated with less hospitalization and better social adjustment , but insight into mental illness or psychotic experience was not . It was also found that insight could neither predict suicidal behavior or violent tendencies . Therefore , some dimension of insight may predict hospitalization and social adjustment in schizophrenics , although its predictive efficacy for other clinical outcomes and behaviors may be limited BACKGROUND The MacArthur Violence Risk Assessment Study ( MacVRAS ) in the USA provided strong evidence to support an actuarial approach in community violence risk assessment . AIMS To examine the predictive accuracy of the MacVRAS measures , in addition to structured professional judgement , in a UK sample of patients discharged from in-patient care in the north-west of Engl and . METHOD A prospect i ve study of 112 participants assessed pre-discharge and followed up at 24
Output:
| However , there is evidence of some convergence around a small number of high-performing instruments and identification of the components of a high- quality evaluation approach , including AUC analysis .
The upper limits ( AUC ≥ 0.85 ) of instrument-based prediction have probably been achieved and are unlikely to be exceeded using instruments alone . |
MS213908 | ***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 the sensitivity to change of three algofunctional scales for neck pain . METHODS Observational , prospect i ve study . Patients with neck disorders were included . Pain and patients ' perceived h and icap assessed on visual analogue scales ( VAS Pain , VAS H and icap ) , and functional disability measures ( Neck Disability Index , Neck Pain and Disability Scale , Northwick Park Neck Pain Question naire ) were recorded twice , at baseline and at an 11-month follow-up assessment . Sensitivity to change was assessed using the effect size ( ES ) and the st and ardised response mean ( SRM ) , and the non-parametric Spearman 's rank correlation coefficient ( r ) was used to assess the correlation between quantitative variable changes and patients ' overall opinion . Analysis of variance ( ANOVA ) followed by a Tukey-test was performed to determine if the scales distinguished improved , stable , and deteriorated patients . RESULTS Seventy-one patients ( 43 women , mean age 49 years ) were included and evaluated twice at an interval of 11 + /- 2 months . The three scales showed good sensitivity to change . The ANOVA showed a group effect , and individual changes in the scales scores were statistically different in two-by-two comparisons ( improved , stable or deteriorated patients ) . Changes in NPDS scores had the highest correlation with patient 's overall assessment ( r = 0.592 ) . CONCLUSION The three scales can detect changes in patients with neck disorders . Changes in NPDS score had the best correlation with patients ' overall opinion concerning their neck disorder and this question naire should be given preference in clinical trials STUDY DESIGN Prospect i ve , single-group observational design . OBJECTIVES To determine the minimal clinical ly important difference ( MCID ) for the Disabilities of the Arm , Shoulder and H and ( DASH ) outcome measure and its shortened version ( QuickDASH ) in patients with upper-limb musculoskeletal disorders , using a triangulation of distribution- and anchor-based approaches . BACKGROUND Meaningful threshold change values of outcome tools are crucial for the clinical decision-making process . METHODS The DASH and QuickDASH were administered to 255 patients ( mean ± SD age , 49 ± 15 years ; 156 women ) before and after a physical therapy program . The external anchor administered after the program was a 7-point global rating of change scale . RESULTS The test-retest reliability of the DASH and QuickDASH was high ( intraclass correlation coefficient model 2,1 = 0.93 and 0.91 , respectively ; n = 30 ) . The minimum detectable change at the 90 % confidence level was 10.81 points for the DASH and 12.85 points for the QuickDASH . After triangulation of these results with those of the mean-change approach and receiver-operating-characteristic-curve analysis , the following MCID values were selected : 10.83 points for the DASH ( sensitivity , 82 % ; specificity , 74 % ) and 15.91 points for the QuickDASH ( sensitivity , 79 % ; specificity , 75 % ) . After treatment , the MCID threshold was reached/surpassed by 61 % of subjects using the DASH and 57 % using the QuickDASH . CONCLUSION The MCID values from this study for the DASH ( 10.83 points ) and the QuickDASH ( 15.91 points ) could represent the lower boundary for a range of MCID values ( reasonably useful for different population s and context ual characteristics ) . The upper boundary may be represented by the 15 points for the DASH and 20 points for the QuickDASH proposed by the DASH website OBJECTIVE This study compares the sensitivity to change of the Neck Disability Index ( NDI ) and the Neck Bournemouth Question naire ( NBQ ) in patients with chronic uncomplicated neck pain . METHODS This prospect i ve longitudinal study was completed in an outpatient physical therapy clinic . Subjects , with uncomplicated neck pain ( no concurrent shoulder pain or nerve root symptoms ) for more than a 3-month duration , participated in a 4-week course of therapy that included moist heat , neck exercises , and either mobilization or massage . Outcome measures included st and ardized response means ( sensitivity to change ) , Cronbach alpha ( internal consistency ) , and 2-way Spearman correlations between the 2 question naires and between a pain Visual Analog Scale and each question naire ( convergent validity ) . RESULTS Mean ( SD ) score change of the NDI was 6.22 ( 5.12 ) , and of the NBQ , 14.00 ( 11.99 ) . St and ardized response means were 1.21 and 1.17 , respectively . Both question naires were more sensitive to change than the pain Visual Analog Scale ( 0.68 ) . There was moderate correlation between the change scores of all 3 outcome tools ( Spearman 0.46 - 0.57 ) . The NBQ had higher internal consistency than the NDI . CONCLUSIONS The NDI and the NBQ performed comparably in this group of patients with chronic uncomplicated neck pain . Both are sensitive to change and would be efficient outcome tools in studies of chronic neck pain . Both had acceptable internal consistency and are appropriate for use as single- outcome scales Self question naires are an important aspect of the management of neck pain patients . The Bournemouth Question naire ( BQ ) , based on the biopsychosocial model , is design ed to evaluate patients with neck pain . The vali date d English version of this question naire ( BQc-English ) has psychometric properties that range from moderate to excellent . The goal of this study is to translate and vali date a French version of the Bournemouth Question naire for neck pain patients ( BQc-f ) . Its translation and adaptation are performed using the translation back-translation method , generating a consensus among the translators . This validation study was performed on 68 subjects ( mean age 41 years old ) who participated in a r and omized controlled trial regarding the efficiency of manual therapy for neck pain patients . This experimental protocol was design ed to generate data in order to evaluate the construct validity , longitudinal validity , test-retest reliability and responsiveness . The BQc-f psychometric properties of construct validity ( r = 0.67 , 0.61 , 0.42 ) for pre treatment , post treatment and longitudinal validity , respectively ) , test-retest reliability ( r = 0.97 ) and responsiveness ( effect size = 0.56 and mean st and ardized response = 0.61 ) are sufficient to suggest it could be used in the management of patients with neck pain Study Design . Observational prospect i ve study . Objective . Vali date the Spanish version of the Neck Disability Index ( NDI ) . Summary of Background Data . The NDI is the most widely used neck pain scale in the largest number of population s and has been vali date d most often against multiple measurements of function , pain , and clinical signs and symptoms . Methods . The Spanish version of the NDI was administered 2 or 3 times to 175 individuals with neck pain ( including those requesting or not requesting specific healthcare at a given time and those with acute and subacute/chronic nonspecific or post-traumatic neck pain ) . After establishing the factorial structure by extracting the main components , the internal consistency was assessed with the Cronbach alpha method , the test-retest reliability was assessed with the Bl and -Altman plot and the intraclass correlation coefficient methods , and the validity was established by calculating Pearson correlation coefficient with pain visual analogue scale values and with Northwick Park Neck Pain Question naire ( Spanish version ) values . Sensitivity to change was estimated while comparing the mean difference between the first application of the NDI score and the one after the treatment in the patients who improved , felt the same , or worsened . Results . A single factor explained 51.6 % of the variance , the Cronbach alpha score was 0.89 , the intraclass correlation coefficient was 0.98 , the Pearson correlation coefficient with pain visual analogue scale was r = 0.65 and with Northwick Park Neck Pain Question naire was r = 0.89 . In the subgroup of 147 subjects in whom the sensitivity to change was studied , those who reported an improvement in neck pain showed a decrease in the NDI score of 8.20 , those who felt the same showed a decrease of 0.23 , and those who felt worse showed an increase of 5.55 . Conclusion . This first Spanish version of the Neck Disability Index is reliable , valid , and sensitive to change Study Design . A prospect i ve cohort study with a 7‐week follow‐up of 113 patients with chronic neck pain undergoing physiotherapy . Objective . To examine the responsiveness of the Portuguese Version of the Neck Disability Index ( NDI‐PT ) , and to determine the minimal clinical ly important difference ( MCID ) , minimal detectable change ( MDC ) , and floor/ceiling effects . Summary of Background Data . Studies that determine MDC and MCID are needed to provide more accurate outcome evaluation and critically assess potential relevant sources for differences in the minimal important change values for the NDI . Methods . The NDI‐PT was administered twice : at the baseline and after 7 weeks of physiotherapy treatment . A Global Transition Scale was used as an external criterion measure to distinguish between improved and nonimproved patients ’ scores between baseline and follow‐up . The responsiveness of the NDI‐PT was assessed through anchor‐based methods ( correlation coefficient and receiver operating characteristics curves — ROC curves ) . The MCID was estimated by the ROC curve method , and the MDC through the st and ard Error of Measurement ( SEM ) . Results . The NDI‐PT revealed moderate responsiveness when applied to patients with chronic neck pain undergoing physiotherapy ( & rgr ; = 0.328 and area under the curve of 0.595 , 95 % confidence interval : 0.484–0.706 ) . The MDC achieved 12 points , whereas the MCID was found to be 5.5 points . A complementary ROC analysis based on percentage differences in NDI‐PT scores from baseline revealed an optimal cutoff point of 27 % . The optimal cutoff point was found to be dependent of disability baseline scores . Conclusion . The NDI‐PT demonstrated moderate levels of responsiveness . The amount of change in question naire scores perceived by the patient to be meaningful is smaller than the amount of change required to be statistically 95 % confident that score change is not just measurement error . Level of Evidence : PURPOSE Report the test-retest reliability , construct validity , minimum clinical ly important difference ( MCID ) , and minimal detectable change ( MDC ) for the Neck Disability Index ( NDI ) . STUDY DESIGN / SETTING Cohort study of patients presenting to outpatient physical therapy clinics . PATIENT SAMPLE Ninety-one subjects with a primary complaint of neck pain , with or without concomitant upper extremity ( UE ) symptoms , who were participants in a r and omized clinical trial . OUTCOME MEASURES NDI and the 15-point Global Rating of Change ( GRC ) self-report measures . METHODS All subjects completed the NDI at baseline and at a 3-week follow-up . Additionally , subjects completed the GRC scale , which was used to dichotomize patients into improved or stable groups . Changes in the NDI were used to assess test-retest reliability , construct validity , MCID , and MDC . RESULTS Test-retest reliability was moderate for the NDI ( intraclass correlation coefficient , 0.64 ; 95 % confidence interval , 0.19 - 0.84 ) . For the NDI , the MCID was 7.5 points and the MDC was 10.2 points . CONCLUSIONS The NDI appears to demonstrate adequate responsiveness based on statistical reference criteria when used in a sample that approximates the high percentage of patients with neck pain and concomitant UE referred symptoms . Because the MCID is within the bounds of measurement error , a 10-point change ( the MDC ) should be used as the MCID A prospect i ve cohort study with a 1 week follow-up . To examine the reliability and responsiveness of the Dutch version of the Neck Disability Index ( NDI ) in patients with acute neck pain in general practice . An increasing number of studies on treatment options is published in which the NDI is used . Reports of the ability of the NDI to detect change over time , often called responsiveness , however have not yet been published . At baseline 187 patients ( 119 women , 68 men ) were included . They completed a question naire on demographic variables , self-reported cause of their complaints and the NDI . After 1 week , 86 patients were sent the NDI again together with the perceived recovery scale which was used as our external criterion . The scale ranged from 1 ( complete recovery ) to 7 ( complaints are worse than ever ) . Response rate was 93 % . Test – retest scores on reliability were good ( ICC = 0.90 ) . A Bl and and Altman plot and a graph of total sum score differences showed no visible tendency towards unequal spreading of the data . For patients that reported on the perceived recovery scale that they were “ stable ” we found a responsiveness ratio of 1.82 . The st and ard error of measurement ( SEM ) was 0.60 what result ed in a minimal detectable change ( MDC ) of 1.66 . The NDI has shown to be a reliable and responsive instrument in patients with acute neck pain in general practice Study Design . Prospect i ve , single-cohort study . Objective . To assess the minimal clinical ly important change ( MCIC ) on the Neck Disability Index ( NDI ) and the Numerical Rating Scale ( NRS ) for pain in patients with neck pain . Summary of Background Data . Both measurement instruments are frequently used in research and clinical practice , but which changes are clinical ly relevant is still unknown . Methods . The MCIC was estimated with 2 different methods , both integrating an anchor-based and distribution-based approach : the minimal detectable change ( MDC ) and the optimal cutoff point of the ROC curve . The study population consisted of 183 patients with nonspecific neck pain . Results . The results show an MDC of 10.5 points for the NDI ( scale range
Output:
| Conclusions Several patient-reported outcome measures are now available for assessing Italian people with non-specific neck pain .
While the Neck Disability Index is the one most widely used , the Neck Bournemouth Question naire appears the most promising tool from a psychometric point of view |
MS213909 | ***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 Only 15 to 20 percent of patients with chronic hepatitis C have a sustained virologic response to interferon therapy . We compared the efficacy and safety of recombinant interferon alfa-2b alone with those of a combination of interferon alfa-2b and ribavirin for the initial treatment of patients with chronic hepatitis C. METHODS We r and omly assigned 912 patients with chronic hepatitis C to receive st and ard-dose interferon alfa-2b alone or in combination with ribavirin ( 1000 or 1200 mg orally per day , depending on body weight ) for 24 or 48 weeks . Efficacy was assessed by measurements of serum hepatitis C virus ( HCV ) RNA and serum aminotransferases and by liver biopsy . RESULTS The rate of sustained virologic response ( defined as an undetectable serum HCV RNA level 24 weeks after treatment was completed ) was higher among patients who received combination therapy for either 24 weeks ( 70 of 228 patients , 31 percent ) or 48 weeks ( 87 of 228 patients , 38 percent ) than among patients who received interferon alone for either 24 weeks ( 13 of 231 patients , 6 percent ) or 48 weeks ( 29 of 225 patients , 13 percent ) ( P<0.001 for the comparison of interferon alone with both 24 weeks and 48 weeks of combination treatment ) . Among patients with HCV genotype 1 infection , the best response occurred in those who were treated for 48 weeks with interferon and ribavirin . Histologic improvement was more common in patients who were treated with combination therapy for either 24 weeks ( 57 percent ) or 48 weeks ( 61 percent ) than in those who were treated with interferon alone for either 24 weeks ( 44 percent ) or 48 weeks ( 41 percent ) . The drug doses had to be reduced and treatment discontinued more often in patients who were treated with combination therapy . CONCLUSIONS In patients with chronic hepatitis C , initial therapy with interferon and ribavirin was more effective than treatment with interferon alone BACKGROUND / AIMS Interferon-alpha plus ribavirin seem to be more efficacious than interferon monotherapy in chronic hepatitis C. In a multicenter r and omized trial , we evaluated the efficacy of this association for interferon-alpha resistant chronic hepatitis C. METHODS Fifty patients who were non-responders to recombinant or lymphoblastoid interferon-alpha were r and omized to receive either ribavirin ( 800 mg/day ) plus leucocytic interferon-alpha ( 3 mega units thrice weekly ) or the same dose of interferon-alpha alone , for 6 months . Effects of therapy were evaluated by serum aminotransferase and hepatitis C virus RNA levels and control liver biopsies . RESULTS At the end of treatment , aminotransferase levels become normal in 9/26 patients receiving combination therapy ( 35 % [ confidence interval , 16 % to 53 % ] ) and in 2/24 receiving interferon-alpha alone ( 8 % [ confidence interval , -3 % to 19 % ] ) ( p = 0.03 ) . Aminotransferase normalization was never associated with hepatitis C virus RNA clearance . All patients with normal aminotransferase relapsed after discontinuation of therapy . At the end of treatment , mean hepatitis C virus RNA levels significantly decreased only in the group receiving combination therapy , but returned to pretreatment values 6 months thereafter . No histological improvement was observed in either group . CONCLUSIONS There is no indication for treatment with interferon-alpha at the dose of 3 mega units thrice weekly plus 800 mg/day of ribavirin for 6 months in chronic hepatitis C resistant to interferon-alpha 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 BACKGROUND A sustained virological response ( SVR ) rate of 41 % has been achieved with interferon alfa-2b plus ribavirin therapy of chronic hepatitis C. In this r and omised trial , peginterferon alfa-2b plus ribavirin was compared with interferon alfa-2b plus ribavirin . METHODS 1530 patients with chronic hepatitis C were assigned interferon alfa-2b ( 3 MU subcutaneously three times per week ) plus ribavirin 1000 - 1200 mg/day orally , peginterferon alfa-2b 1.5 microg/kg each week plus 800 mg/day ribavirin , or peginterferon alfa-2b 1.5 microg/kg per week for 4 weeks then 0.5 microg/kg per week plus ribavirin 1000 - 1200 mg/day for 48 weeks . The primary endpoint was the SVR rate ( undetectable hepatitis C virus [ HCV ] RNA in serum at 24-week follow-up ) . Analyses were based on patients who received at least one dose of study medication . FINDINGS The SVR rate was significantly higher ( p=0.01 for both comparisons ) in the higher-dose peginterferon group ( 274/511 [ 54 % ] ) than in the lower-dose peginterferon ( 244/514 [ 47 % ] ) or interferon ( 235/505 [ 47 % ] ) groups . Among patients with HCV genotype 1 infection , the corresponding SVR rates were 42 % ( 145/348 ) , 34 % ( 118/349 ) , and 33 % ( 114/343 ) . The rate for patients with genotype 2 and 3 infections was about 80 % for all treatment groups . Secondary analyses identified bodyweight as an important predictor of SVR , prompting comparison of the interferon regimens after adjusting ribavirin for bodyweight ( mg/kg ) . Side-effect profiles were similar between the treatment groups . INTERPRETATION In patients with chronic hepatitis C , the most effective therapy is the combination of peginterferon alfa-2b 1.5 microg/kg per week plus ribavirin . The benefit is mostly achieved in patients with HCV genotype 1 infections BACKGROUND Interferon alfa is the only effective treatment for patients with chronic hepatitis C. Forty percent of patients have an initial response to this therapy , but most subsequently relapse . We compared the effect of interferon alone with that of interferon plus oral ribavirin for relapses of chronic hepatitis C. METHODS We studied 345 patients with chronic hepatitis C who relapsed after interferon treatment . A total of 173 patients were r and omly assigned to receive st and ard-dose recombinant interferon alfa-2b concurrently with ribavirin ( 1000 to 1200 mg orally per day , depending on body weight ) for six months , and 172 patients were assigned to receive interferon and placebo . RESULTS At the completion of treatment , serum levels of hepatitis C virus ( HCV ) RNA were undetectable in 141 of the 173 patients who were treated with interferon and ribavirin and in 80 of the 172 patients who were treated with interferon alone ( 82 percent vs. 47 percent , P<0.001 ) . Serum HCV RNA levels remained undetectable 24 weeks after the end of treatment in 84 patients ( 49 percent ) in the combination-therapy group , but in only 8 patients ( 5 percent ) in the interferon group ( P<0.001 ) . Sustained normalization of serum alanine aminotransferase concentrations and histologic improvement were highly correlated with virologic response . Base-line serum HCV RNA levels of 2 x 10(6 ) copies per milliliter or less were associated with higher rates of response in both treatment groups . Viral genotypes other than type 1 were associated with sustained responses only in the combination-therapy group . Combined therapy caused a predictable fall in hemoglobin concentrations but otherwise had a safety profile similar to that of interferon alone . CONCLUSIONS In patients with chronic hepatitis C who relapse after treatment with interferon , therapy with interferon and oral ribavirin results in higher rates of sustained virologic , biochemical , and histologic response than treatment with interferon alone BACKGROUND Only 15 - 20 % of patients with chronic hepatitis C achieve a sustained virological response with interferon therapy . The aim of this study was to compare the efficacy and safety of interferon alpha2b in combination with oral ribavirin with interferon alone , for treatment of chronic infection with hepatitis C virus ( HCV ) . METHODS 832 patients aged 18 years or more with chronic HCV who had not been treated with interferon or ribavirin , were enrolled and r and omly allocated one of three regimens : 3 mega units ( MU ) interferon alpha2b three times a week plus 1000 - 1200 mg ribavirin per day for 48 weeks ; 3 MU interferon alpha2b three times a week plus 1000 - 1200 mg ribavirin per day for 24 weeks ; or 3 MU interferon alpha2b three times a week and placebo for 48 weeks . All patients were assessed for safety , tolerance , and efficacy at the end of weeks 1 , 2 , 4 , 6 , and 8 , and every 4 weeks during treatment . After treatment was completed patients were followed up on weeks 4 , 8 , 12 , and 24 . The primary endpoint was loss of detectable HCV-RNA ( serum HCV-RNA < 100 copies/mL ) at week 24 after treatment . FINDINGS Sustained virological response at 24 weeks after treatment , was found in 119 ( 43 % ) of the 277 patients treated for 48 weeks with the combination regimen , 97 ( 35 % ) of the 277 patients treated for 24 weeks with the combination regimen ( p = O.055 ) , and 53 ( 19 % ) of the 278 patients treated for 48 weeks with interferon alone ( p<0.001 vs both combination regimens , intention-to-treat analysis ) . Logistic regression identified five independent factors significantly associated with response : genotype 2 or 3 , viral load less than 2 million copies/mL , age 40 years or less , minimal fibrosis stage , and female sex . Among patients with fewer than three of these factors the odds ratio of sustained response was 2.6 ( 95 % Cl 1.4 - 4.8 ; p=0.002 ) for the 48 week combination regimen compared with 24 weeks of the combination regimen . Discontinuation of therapy for adverse events was more frequent with combination ( 19 % ) and monotherapy ( 13 % ) given for 48 weeks than combination therapy given for 24 weeks ( 8 % ) . INTERPRETATION An interferon alpha2b plus ribavirin combination is more effective than 48 weeks of interferon alpha2b monotherapy and has an acceptable safety profile . Patients with few favourable factors benefit more from extending the duration of combination therapy to 48 weeks Methods for combining data from several studies exist and appear to be quite useful . None satisfactorily addresses the question of what studies should be combined . This issue is the most serious method ological limitation . Even studies with statistically significant interaction might still be combined if the effect were in the same direction . Thus , substantial scientific input is required as to what criteria must be met by each potential study . Much can be learned from combining or pooling data but it must
Output:
| Combination therapy also significantly improved liver histologic response .
The effects on quality of life are unclear .
However , combination therapy significantly increased the risk of hematological , dermatological , gastrointestinal , and several other types of adverse events .
In conclusion , the effect of ribavirin plus interferon on viral clearance may lead to reduced mortality and morbidity in patients with chronic hepatitis C infection .
However , combination therapy is associated with increased risk for adverse events |
MS213910 | ***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 the effectiveness of angiotensin converting enzyme inhibition in preventing the development of diabetic nephropathy ( albuminuria greater than 300 mg/24h ) . DESIGN --Open r and omised controlled study of four years ' duration . SETTING --Outpatient diabetic clinic in tertiary referral centre . PATIENTS --44 normotensive ( mean blood pressure 127/78 ( SD 12/10 ) mm Hg ) insulin dependent diabetic patients with persistent microalbuminuria ( 30 - 300 mg/24h ) . INTERVENTIONS --The treatment group ( n = 21 ) was initially given captopril ( 25 mg/24 h ) . The dose was increased to 100 mg/24 h during the first 16 months and thiazide was added after 30 months . The remaining 23 patients were left untreated . MAIN OUTCOME MEASURES --Albuminuria , kidney function , development of diabetic nephropathy ( albuminuria greater than 300 mg/24 h ) , and arterial blood pressure . RESULTS -- Clinical and laboratory variables were comparable at baseline . Urinary excretion of albumin was gradually reduced from 82 ( 66 - 106 ) to 57 ( 39 - 85 ) mg/24 h ( geometric mean ( 95 % confidence interval ) ) in the captopril treated group , whereas an increase from 105(77 - 153 ) to 166 ( 83 - 323 ) mg/24 h occurred in the control group ( p less than 0.05 ) . Seven of the untreated patients progressed to diabetic nephropathy , whereas none of the captopril treated patients developed clinical overt diabetic nephropathy ( p less than 0.05 ) . Systemic blood pressure , glomerular filtration rate , haemoglobin A1c concentration , and urinary excretion of sodium and urea remained practically unchanged in the two groups . CONCLUSIONS --The findings suggest that angiotensin converting enzyme inhibition postpones the development of clinical overt diabetic nephropathy in normotensive insulin dependent diabetic patients with persistent microalbuminuria Abstract This study tested the hypothesis that passive exposure to posters containing essential information on cardiopulmonary resuscitation ( CPR ) displayed on lavatory walls improves theoretical knowledge and the performance of CPR . There was a significant increase in both knowledge and performance of CPR after exposure to the posters . This technique is inexpensive and simple , and it warrants more widespread use as a means of maintaining knowledge and proficiency in CPR Recent studies utilizing converting enzyme inhibitors ( CEI ) in diabetic rats document reductions in both renal hypertrophy and albuminuria . Four separate clinical studies in normotensive patients with diabetes demonstrate reduction of microalbuminuria with CEIs independent of blood pressure reduction . The present pilot study examines the results of reducing an elevated glomerular filtration rate on changes in renal size and microalbuminuria in normotensive , hyperfiltering insulin-dependent diabetic ( IDDM ) patients . Fifteen IDDM patients were r and omized to either placebo or the CEI , lisinopril . Dosage of lisinopril was titrated over 3 months to reduce glomerular filtration rate ( GFR ) to < or = 2.33 mL/sec . Evaluation at 18 months demonstrated the lisinopril group had a marked reduction in renal size ( 16.9 + /- 1.1 , baseline versus 12.8 + /- 0.9 cm , 18 months ; p < 0.05 ) and microalbuminuria ( 92 + /- 11 micrograms/min , baseline versus 23 + /- 26 micrograms/min , 18 months ; p < 0.05 ) . No change in renal size was noted in the placebo group ( 15.4 + /- 0.8 , baseline versus 14.9 + /- 0.7 cm , 18 months ; NS ) and albuminuria increased ( 118 + /- 15 micrograms/min , baseline versus 293 + /- 32 micrograms/min , 18 months ; p < 0.05 ) . Mean arterial pressure at 18 months was significantly lower in the lisinopril group compared to placebo ( 102 + /- 4 , placebo versus 87 + /- 6 mm Hg , CEI , p < 0.05 ) . This study supports previous animal studies that document reductions in both microalbuminuria and renal size by a CEI . The overall impact of these findings on preservation of renal function can not be assessed , however , in this short-term study PURPOSE To determine whether angiotensin-converting enzyme ( ACE ) inhibition with captopril reduces the progression of microalbuminuria to overt proteinuria in normotensive patients with insulin-dependent diabetes mellitus ( IDDM ) . PATIENTS AND METHODS This study was a prospect i ve r and omized , double-blind , placebo-controlled trial involving 26 centers in the United States and Canada . One hundred forty-three subjects , 14 to 57 years of age , with IDDM for 4 to 33 years , blood pressure < 140/90 mm Hg in the absence of antihypertensive therapy , and persistent albumin excretion 20 to 200 micrograms/min were r and omized to double-blind treatment with captopril 50 mg or placebo BID . Albumin excretion rate ( AER ) , blood pressure , and glycohemoglobin were determined every 3 months , and creatinine clearance ( CrCl ) and urea excretion were measured every 6 months . RESULTS Within 24 months , 6.0 % ( 4/67 ) of captopril-treated subjects and 18.6 % ( 13/70 ) of placebo-treated subjects progressed to clinical proteinuria , defined as AER > 200 micrograms/min and at least 30 % above baseline ( risk reduction = 67.8 % , P = 0.037 ) . AER increased at an annual rate of 11.8 % ( 95 % confidence interval [ CI ] -3.3 % to 29.1 % ) in the placebo group , while it declined by 17.9 % ( CI -29.6 % to -4.3 % ) in the captopril group ( P = 0.004 ) . CrCl decreased by 4.9 mL/min per 1.73 m2 per year in the placebo group , while it remained stable in the captopril group ( 0.9 mL/min per 1.73 m2 per year , P = 0.039 between groups ) . Ten subjects required treatment for hypertension ; 8 in the placebo group and 2 in the captopril group . There was little correlation between the 24-month changes in mean arterial blood pressure and AER in either group . Glycohemoglobin and urinary urea excretion did not differ between groups . CONCLUSIONS After 24 months of therapy with captopril , compared with placebo , normotensive subjects with IDDM experienced significantly less progression of microalbuminuria to clinical proteinuria , reduced albumin excretion , and preserved CrCl rate . The ACE inhibitor , captopril , was well tolerated The effect of long term , aggressive antihypertensive treatment on kidney function in diabetic nephropathy was studied prospect ively in 11 insulin dependent diabetics ( mean age 30 ) . During the mean pretreatment period of 32 ( range 23 - 66 ) months the glomerular filtration rate decreased significantly and albuminuria and the arterial blood pressure increased significantly . During the 72 ( range 32 - 91 ) month period of antihypertensive treatment the average arterial blood pressure fell from 143/96 mm Hg to 129/84 mm Hg and albuminuria decreased from 1038 micrograms/min to 504 micrograms/min . The rate of decline in the glomerular filtration rate decreased from 0.89 ( range 0.44 - 1.46 ) ml/min/month before treatment to 0.22 ( range 0.01 - 0.40 ) ml/min/month during treatment . The rate of decline in the glomerular filtration rate was significantly smaller during the second three years compared with the first three years in patients who received long term antihypertensive treatment ( greater than or equal to 6 years ) . One patient died from acute myocardial infa rct ion ( glomerular filtration rate 46 ml/min/1.74 m2 ) . Effective antihypertensive treatment postpones renal insufficiency in diabetic nephropathy The effects of a long term reduction in blood pressure on the kidney function of normotensive diabetic patients who had persistent microalbuminuria ( 30 - 300 mg albumin/24 hours ) were studied in two groups of 10 such patients before and during six months of treatment with either 20 mg enalapril or placebo daily . Treatments were assigned r and omly in a double blind fashion . Before treatment both groups had similar clinical characteristics , weight , diet , total glycosylated haemoglobin , median albumin excretion rate ( enalapril group 124 mg/24 h , placebo group 81 mg/24 h ) , and mean arterial pressure ( enalapril group 100 ( SD 8) mm Hg , placebo group 99 ( 6 ) mm Hg ) . During treatment weight , urinary urea excretion , and total glycosylated haemoglobin remained unchanged . The mean arterial pressure decreased in the enalapril group but not in the placebo group ( enalapril group 90 ( 10 ) mm Hg , placebo group 98 ( 8) mm Hg ) . The median albumin excretion rate also fell in the enalapril group but not in the placebo group ( enalapril group 37 mg/24 h , placebo group 183 mg/24 h. ) The glomerular filtration rate rose in the enalapril group from 130 ( 23 ) ml/min/1.73 m2 to 141 ( 24 ) ml/min/1.73 m2 , and total renal resistances and fractional albumin clearance decreased while fractional albumin clearance increased in the placebo group . These results show that in patients who have diabetes but not hypertension a reduction in blood pressure by inhibition of converting enzyme for six months can reduce persistent microalbuminuria , perhaps by decreasing the intraglomerular pressure OBJECTIVE To study the effect of Captopril on ambulatory blood pressure , renal and cardiac function and extracellular volume in microalbuminuric Type 1 diabetic patients . DESIGN R and omized , double blind placebo controlled study of two years duration . SETTING University clinic . PATIENTS Twenty-two patients without hypertension . INTERVENTION Patients received 50 mg Captopril or placebo twice a day . MEASUREMENTS Ambulatory blood pressure , renal function , extracellular volume , and echocardiographic indices of cardiac function and dimensions were assessed annually . Clinic blood pressure and urinary albumin excretion were measured every 3 months . RESULTS Twenty-four hour mean arterial blood pressure was unchanged in the Captopril group ( mean + /- SD ) ( baseline 93 + /- 4 and follow up 91 + /- 8 mmHg ) and in the placebo group ( 96 + /- 7 and 97 + /- 10 mmHg , NS ) . Night/day ratio of blood pressure was unaffected . Glomerular filtration rate was unchanged and renal plasma flow increased in the Captopril ( 557 + /- 97 and 600 + /- 112 ml min-1 ) versus the placebo group ( 574 + /- 85 and 535 ml min-1 , p = 0.05 ) . Filtration fraction was reduced in the Captopril versus the placebo group ( p < 0.05 ) . Extracellular volume and echocardiographically derived parameters were unaffected . The relative change in day time mean arterial blood pressure in the Captopril group correlated with changes in urinary albumin excretion ( Spearmans r = 0.85 , p < 0.05 ) unlike clinic mean arterial blood pressure ( r = 0.33 , p = 0.35 ) . CONCLUSION Diurnal rhythm of blood pressure was unaffected by long term administration of Captopril . Renal plasma flow was increased and filtration fraction reduced . A significant association between changes in urinary albumin excretion and blood pressure after Captopril was revealed only by the implementation of ambulatory blood pressure measurements Based on animal experiments it has been proposed that antihypertensive agents may differentially influence albuminuria through their divergent effects on glomerular haemodynamics or glomerular sieving properties and may beneficially influence the progression of diabetic nephropathy even without an effect on blood pressure . However , to date this hypothesis has not been tested in normotensive patients with diabetic nephropathy . The main aim of this study was therefore to investigate the effects of the administration of two antihypertensive agents on albuminuria during rest and exercise . The study consisted of 3 x 3 r and omised , cross-over periods with five days double blind administration of enalapril ( E : 2.5 mg bid ) , nitrendipine ( N : 5 mg bid ) and placebo ( P ) on 18 Type 1 normotensive ( blood pressure < 140/90 mmHg ) di
Output:
| Treatment provided a significant reduction in albumin excretion rate in both insulin dependent diabetes mellitus and non insulin dependent diabetes mellitus .
Treatment with either captopril , enalapril or lisinopril reduced albumin excretion rate in comparison with control patients .
A greater lowering of blood pressure was experienced by initially normotensive patients in the angiotensin converting enzyme inhibitor than in the placebo group .
Pooled end-of- study mean blood pressures for the treated group were significantly lower than for the untreated group , although this was not so for all individual studies .
The apparent ( treatment - placebo ) ' effect ' on systolic and diastolic pressures had a larger st and ard error for longer lasting studies .
Average haemoglobin fell a little in the treated patients and rose in the controls but neither this nor the difference in changes in glomerular filtration rate reached statistical significance .
REVIEW ER 'S CONCLUSIONS Inhibition of angiotensin converting enzyme can arrest or reduce the albumin excretion rate in microalbuminuric normotensive diabetics , as well as reduce or prevent an increase in blood pressure .
But , given the drop in blood pressure in patients on angiotensin converting enzyme inhibitors , it is not possible to be certain that the reduction of albumin excretion rate is due to a separate renal effect .
A direct link with postponement of end-stage renal failure has not been demonstrated .
There appear to be no substantial side effects |
MS213911 | ***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 whether clinical errors can be reduced by prospect i ve computer suggestions about the management of simple clinical events , I studied the responses of nine physicians to computer suggestions generated by 390 protocol s in a controlled crossover design . These protocol s dealt primarily with conditions managed ( e.g. , elevated blood pressure ) or caused ( e.g. , liver toxicity ) by drugs . Physicians responded to 51 per cent of 327 events when given , and 22 per cent of 385 events when not given computer suggestions . Neither level of postgraduate training ( first-year postgraduate or third-year post-graduate ) nor the order in which physicians served as study and control subjects had statistically significant overall effect on the results . It appears that the prospect i ve reminders do reduce errors , and that many of these errors are probably due to man 's limitations as a data processor rather than to correctable human deficiencies In an examination of the relationships among plasma aminoglycoside concentrations , the minimal inhibitory concentration ( MIC ) for the infecting organism , and therapeutic outcome , data were analyzed from 236 patients with gram-negative bacterial infections who were participants in four clinical trials of gentamicin , tobramycin , and amikacin . Clinical response to therapy occurred in 188 ( 80 % ) patients . Elevated maximal and mean peak aminoglycoside concentration/MIC ratios were strongly associated with clinical response ( P less than .00001 and P less than .0001 , respectively ) . A grade d dose-response effect was found between an increasing maximal peak concentration/MIC ratio and clinical response . By logistic regression the peak concentration/MIC ratios were associated significantly with clinical response after adjustment for underlying severity of illness and other factors correlated with response . These results demonstrate that a high peak concentration relative to the MIC for the infecting organism is a major determinant of the clinical response to aminoglycoside therapy To determine the association of aminoglycoside plasma levels with therapeutic outcome in gram-negative pneumonia , the case reports of 37 patients from four prospect i ve , r and omized , controlled trials of gentamicin , tobramycin , and amikacin were analyzed . Twenty ( 54 percent ) of these patients had a favorable outcome . Patients with maximal one-hour postinfusion ( peak ) levels of 7 micrograms/ml or greater for gentamicin and tobramycin or 28 micrograms/ml or greater for amikacin more often had successful outcomes ( 14 of 20 , 70 percent ) than those with levels less than this ( six of 19 , 32 percent ) ( p less than 0.006 ) . Patients with overall mean peak levels of 6 micrograms/ml or greater for gentamicin and tobramycin or 24 micrograms/ml or greater for amikacin more often had successful outcomes than those with levels less than this ( six of 17 , 35 percent ) ( p less than 0.04 ) . The initial patient temperature , serum urea nitrogen/creatinine ratio , initial polymorphonuclear leukocyte count , and age were also associated with outcome ; but by multivariate analysis , achieving an adequate peak concentration was the most important discriminating factor . These results suggest the potential importance of achieving adequate aminoglycoside levels in patients with gram-negative pneumonia To determine the association of aminoglycoside levels with mortality from gram-negative bacteremia , we analyzed the case reports of patients from four prospect i ve , r and omized , and controlled clinical trials of gentamicin , tobramycin , and amikacin . Twelve ( 13.5 % ) of 89 patients died . One ( 2.4 % ) death occurred in 41 patients with early ( 1-hr postinfusion ) peak concentrations of greater than 5 micrograms/ml of gentamicin and tobramycin and of greater than 20 micrograms of amikacin/ml ; nine deaths ( 20.9 % ) occurred in 43 patients with lower concentrations . Five ( 8.3 % ) deaths occurred in 60 patients with mean peak concentrations for the entire course of therapy of greater than 5 micrograms/ml of gentamicin and tobramycin and of greater than 20 micrograms of amikacin/ml ; five ( 20.8 % ) deaths occurred in 24 patients with lower concentrations . Stepwise discriminant analysis showed that therapeutic early peak concentration was a significant factor in the presence of three other factors : severity of underlying illness , peak temperature , and initial leukocyte count . The results suggest the importance of achieving adequate early aminoglycoside levels in patients with gram-negative bacteremia
Output:
| MAIN RESULTS Twenty-six comparisons ( 23 articles ) were included ( as compared to fifteen comparisons in the original review ) including a wide range of drugs in inpatient and outpatient setting s. Interventions usually targeted doctors although some studies attempted to influence prescriptions by pharmacists and nurses .
This review suggests that computerized advice for drug dosage has some benefits : it increased the initial dose of drug , increased serum drug concentrations and led to a more rapid therapeutic control .
It also reduced the risk of toxic drug levels and the length of time spent in the hospital .
However , it had no effect on adverse reactions .
In addition , there was no evidence to suggest that some decision support technical features ( such as its integration into a computer physician order entry system ) or aspects of organization of care ( such as the setting ) could optimise the effect of computerised advice |
MS213912 | ***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 recovery of patients undergoing total shoulder arthroplasty ( TSA ) can be adversely affected by a number of complications . Autologous platelet gel ( APG ) , produced by activating platelet-rich plasma ( PRP ) , has been shown to improve hemostasis and wound healing and reduce infections in some surgical procedures . Activated platelet-poor plasma ( PPP ) has also been used as a hemostatic agent . This study examines the effects of APG and PPP treatment on TSA patients postoperatively . After Institutional Review Board ( IRB ) approval , 40 patients undergoing TSA at our institution were prospect ively enrolled in our study . They were r and omized into either a control ( n = 20 ) or study ( n = 20 ) group , with the study group receiving APG and PPP treatment . Preoperative demographic data , pre- and postoperative laboratory data , pain scores , pain medication , complications , pre- and postoperative range of motion measurements , and postoperative lengths of stay were recorded for each group . The preoperative internal rotation index was significantly higher in the control group compared with treatment patients ( 4.64 + /- 4.46 vs. 1.88 + /- 2.44 , p < .05 ) . The percent hemoglobin retained postoperatively was higher in the treatment group at 24 ( 84.54 + /- 5.32 vs. 79.87 + /- 8.73 ) and 72 hours ( 87.46 + /- 16.03 vs. 76.70 vs. 5.96 ) , but neither difference reached statistical significance . The treatment group had significantly lower pain scores ( p = .007 ) and total fentanyl requirements ( p < .05 ) compared with control patients . The internal rotation index improvement factor ( postoperative internal rotation index/preoperative internal rotation index ) was significantly higher in the treatment group vs. the control group ( p < .05 ) . Although it did not reach statistical significance , the treatment group was discharged almost 9 hours earlier than the control group ( 64.44 + /- 15.23 vs. 73.39 + /- 15.37 ) . APG and PPP treatment decreased pain and provided a greater increase in internal rotation measurements postoperatively OBJECTIVES The aim of this study was to evaluate the effects of moderately intensive pool exercise therapy on patients with rheumatoid arthritis ( RA ) . METHODS Forty-six patients with chronic RA were r and omly assigned to a treatment group and a control group . The treatment group ( n = 20 ) exercised in a temperate pool twice a week for 12 weeks . The control group ( n = 23 ) continued with their previous activities . Aerobic capacity , measured by means of a submaximum bicycle test , and the physical component of the SF-36 were chosen as the primary outcome measures . Two tests of muscle endurance were chosen as the secondary outcome measure . Additional functional tests and instruments were included . RESULTS No significant differences between the groups were found for the primary outcome measures . Significant improvements in the following aspects of muscular function ( P < 0.05 ) were found in the treatment group when their performance was compared with that of the control group : isometric shoulder endurance , grip force , dynamic endurance of lower extremities ( chair test ) and muscle function of lower extremities . Significant improvements were also found for vitality ( SF-36 ) compared with the control group . The improvements in the training group were maintained for 3 months . CONCLUSIONS Pool exercise therapy of moderate intensity significantly improved muscle endurance in the upper and lower extremities in patients with RA , while no impact on aerobic capacity was found . However , the study population was small and there is a need for further studies with larger population SUMMARY Objective : To evaluate the efficacy and safety of oxaprozin in comparison with diclofenac in patients with periarthritis pain of the shoulder previously unsuccessfully treated with nonsteroidal anti-inflammatory drugs other than diclofenac and oxaprozin . Methods : In this open , multicentre , r and omised , controlled study , eligible patients with periarthritis of the shoulder were r and omised to receive either oxaprozin 1200 mg once daily ( n = 49 ) or diclofenac 50 mg three times daily ( n = 47 ) . The treatment period was 15 ± 1 days . The study was planned on a hypothesis of equivalence between the two study drugs . The primary study endpoint was the change from baseline at day 15 in the patient-assessed shoulder pain score . Secondary efficacy variables included investigator-assessed shoulder function , patient-assessed quality of life on the Short-Form-36 ( SF-36 ) Acute Health Survey and both patients ’ and investigators ’ overall assessment of efficacy . Results : At day 15 , the mean changes in shoulder pain score from baseline in the oxaprozin and diclofenac groups were –5.85 ± SD 4.62 and –5.54 ± SD 4.41 , respectively . The difference between the two groups was not statistically significant , confirming the hypothesis of the study that oxaprozin is as effective as diclofenac . Investigator-assessed shoulder function improved in both groups but more so in the oxaprozin group ( p = 0.028 at day 15 ) . Quality of life as measured by SF-36 total score was also improved in both treatment groups , with a trend toward greater improvement in the oxaprozin group . Furthermore , a significantly more favourable effect on the SF-36 ‘ mental health ’ item was observed in oxaprozin compared with diclofenac-treated patients at day 15 ( p = 0.0202 ) . As assessed by investigators , the overall efficacy of oxaprozin was superior to that for diclofenac at visit 3 ( 8 ± 1 days ) ( p = 0.0067 ) . Patients also assessed the overall efficacy of oxaprozin as superior to that of diclofenac at visits 3 ( 8 ± 1 days ) ( p = 0.0235 ) and 4 ( 15 ± 1 days ) ( p = 0.0272 ) . Only six adverse events , all of which were mild or moderate in intensity and occurred in four diclofenac recipients , were observed in the study . Conclusions : As expected , once-daily oxaprozin proved to be as effective as diclofenac three times daily in reducing the primary efficacy variable of patient-assessed shoulder pain score in patients with periarthritis of the shoulder refractory to previous treatments with other NSAIDs . Oxaprozin was shown to be superior to diclofenac in improving shoulder function and was considered by investigators and patients to have greater overall efficacy than diclofenac . In addition , oxaprozin showed a trend toward superior results in improving patients ’ quality of life compared with diclofenac . A trend towards better tolerability results for oxaprozin compared with diclofenac was also noted HypothesisArthroscopic acromioclavicular joint ( ACJ ) resection for asymptomatic ACJ arthritis combined with rotator cuff repair leads to more satisfactory pain relief and decrease reoperation rate when inferiorly directed osteophytes present at the undersurface of ACJ . Material s and methods Between January 2006 and May 2008 , a total of 83 patients ( 83 shoulders ) , 40 males and 43 females , who were planned to have arthroscopic repair of a tear measuring 1–3 cm in the anterior-posterior dimension with advanced ACJ arthritis with inferiorly directed osteophytes at the undersurface of the ACJ on MRI were entered into this study . Patients were r and omized into two groups . Group 1 included 31 patients , who underwent arthroscopic distal clavicle resection combined with rotator cuff repair . Group 2 included 52 patients , who underwent isolated rotator cuff repair . Patients were evaluated preoperatively and postoperatively using the University of California Los Angeles ( UCLA ) score and the American Shoulder and Elbow Surgeons ( ASES ) score . Pain , tenderness on ACJ , and cross body adduction test were compared between groups . Results The mean follow-up was 31.7 months ( range 34–38 ) . The UCLA scores and ASES scores were lower in group 1 at week 6 ( p < .05 ) , and week 12 ( p < .05 ) , but higher at the last follow-up at 2 years ( p < .05 ) postoperatively . VAS score was higher in group 1 at week 6 ( p < .05 ) , and at week 12 ( p < .05 ) , but lower in group 2 at the last follow-up ( p < .05 ) . Only in group 2 , two ( 3.8 % ) cases developed ACJ pain during follow-up and one ( 1.9 % ) case underwent reoperation for additional ACJ resection . Conclusions This study shows that distal clavicle resection combined with rotator cuff repair for asymptomatic ACJ arthritis with inferiorly directed osteophytes lower functional scores due to temporary pain in early postoperative periods , but better functional outcomes with satisfactory pain relief and no reoperation rate were observed after 2 years Multiple joint replacement in 1 operative session is frequently performed in the lower extremity but less often in the upper extremity . The purpose of the present study is to determine whether a 1-stage arthroplasty of the ipsilateral shoulder and elbow affects the clinical outcome . Replacement of the ipsilateral shoulder and elbow was performed in 34 rheumatoid patients ( 42 upper extremities ) . In 11 patients ( 13 upper limbs ) , the shoulder and elbow arthroplasty was a 1-stage procedure . The average follow-up of the whole group was 4.5 years ( range , 2 - 12 years ) . The patients were in a prospect i ve study and evaluated clinical ly and radiographically . With a 1-stage procedure , the hospitalization time was shorter . The overall Hospital for Special Surgery shoulder score and its items ( pain , function , and strength ) were similar at follow-up in the 2 groups , and only the motion score showed more improvement in the 1-stage group . The clinical outcome of elbow arthroplasty was similar in both groups , regardless of the sequence of surgery . From this study , it may be concluded that a 1-stage procedure for shoulder and elbow arthroplasty will reduce the hospitalization time and does not adversely affect the clinical outcome BACKGROUND Both total shoulder arthroplasty and hemiarthroplasty have been used commonly to treat severe osteoarthritis of the shoulder ; however , their effect on disease-specific quality -of-life outcome is unknown . The purpose of this study was to compare the quality -of-life outcome following hemiarthroplasty with that following total shoulder arthroplasty in patients with osteoarthritis of the shoulder . METHODS Forty-two patients with a diagnosis of osteoarthritis of the shoulder were r and omized to receive a hemiarthroplasty or a total shoulder arthroplasty . One patient died , and all others were evaluated preoperatively and at six weeks and three , six , twelve , eighteen , and twenty-four months postoperatively with use of a st and ardized format including a disease-specific quality -of-life measurement tool ( Western Ontario Osteoarthritis of the Shoulder [ WOOS ] index ) , general shoulder rating scales ( University of California at Los Angeles [ UCLA ] shoulder scale , Constant score , and American Shoulder and Elbow Surgeons [ ASES ] evaluation form ) , general pain scales ( McGill pain score and visual analogue scale ) , and a global health measure ( Short Form-36 [ SF-36 ] ) . When a patient required revision of a hemiarthroplasty to a total shoulder arthroplasty , the last score before he or she " crossed over " was used for the analysis . RESULTS Significant improvements in disease-specific quality of life were seen two years after both the total shoulder arthroplasties and the hemiarthroplasties . There were no significant differences in quality of life ( WOOS score ) between the group treated with total shoulder arthroplasty and that treated with hemiarthroplasty ( 90.6 + /- 13.2 and 81.5 + /- 24.1 points , respectively ; p = 0.18 ) . The other outcome measures demonstrated similar findings . Two patients in the hemiarthroplasty group crossed over to the other group by undergoing a revision to a total shoulder arthroplasty because of glenoid arthrosis . CONCLUSIONS Both total shoulder arthroplasty and hemiarthroplasty improve disease-specific and general quality -of-life measurements . With the small number of patients in our study , we found no significant differences in these measurements between the two treatment groups . LEVEL OF EVIDENCE Therapeutic Level HYPOTHESIS The correct implantation of the glenoid component is of paramount importance in total shoulder arthroplasty ( TSA ) . We hypothesized that the accuracy of the glenoid positioning in the transverse plane can be improved using intraoperative navigation . MATERIAL S AND METHODS This prospect i ve , r and omized clinical study comprised 2 groups of 10 patients each with osteoarthritis of the shoulder TSA , with or without intraoperative navigation . Glenoid version was measured on axial computed tomography scans preoperatively and 6 weeks postoperatively . RESULTS The operating time was significantly longer in the navigation group ( 169.5 + /- 15.2 vs 138 + /- 18.4 min ) . We found an average change of retroversion from 15.4 degrees + /- 5.8 degrees ( range , 3.0 degrees -24.0 degrees ) preoperatively to 3.7 degrees + /- 6.3 degrees ( range , -8.0 degrees to 15.0 degrees ) postoperatively in the navigation group compared with 14.4 degrees + /- 6.1 degrees ( range , 2.0 degrees -24.0 degrees ) preoperatively to 10.9 degrees + /- 6.8 degrees ( range , 0.
Output:
| The studies identified were unable to provide a clear indication of best intervention for shoulder arthritis .
Sparse evidence is available for all other interventions , regardless of whether operative or non-operative . |
MS213913 | ***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 Esophagectomy through cervico-thoraco-abdominal approach is a useful surgical technique in treating patients with esophageal cancer . However , the cervical reconstruction is also known to have a high rate of anastomotic leakage , as well as anastomotic stricture , intrathoracic stomach syndrome , reflux esophagitis and other complications , thereby influencing postoperative recovery and quality of life . Aims The objective of this study was to investigate whether tubular stomach is superior to whole stomach in reducing anastomotic leakage for esophageal reconstruction through the cervico-thoraco-abdominal ( 3-field ) approach . Methods A total of 850 patients undergoing the 3-field esophagectomy were retrospectively included in this study and divided into a tubular stomach reconstruction group ( Group A , n = 453 ) and a whole stomach reconstruction group ( Group B , n = 397 ) . All patients underwent esophagectomy through right thorax , left cervical part , abdominal triple incisions and done in esophageal reconstruction by h and -sewn two-layer anastomosis . Results Results revealed that in comparison with whole stomach , esophageal reconstruction with tubular stomach had a lower incidence of anastomotic leakage ( 5.5 vs. 9.3 % , P < 0.05 ) , less manifestation of intrathoracic syndrome ( 3.3 vs. 9.8 % , P < 0.001 ) and less occurence of reflux esophagitis ( 5.1 vs. 11.1 % , P < 0.01 ) . However , for the incidence of anastomotic stricture , there was no significant difference between the two groups ( 9.3 vs. 9.8 % ) . Conclusions This observation study suggests that for esophageal cancer patients undergoing the 3-field esophagectomy tubular stomach is better than whole stomach for esophageal reconstruction as reflected by a reduced postoperative anastomotic leakage , intrathoracic syndrome and reflux esophagitis Purpose The type of anastomosis and its outcome can affect postoperative morbidity , mortality , and quality of life after esophagectomy . We compared the outcomes of cervical h and -sewn anastomosis ( CHS ) and intrathoracic stapled anastomosis ( ITS ) performed after esophagectomy and gastric reconstruction . Methods Thirty-two patients with middle or lower thoracic esophageal cancer were prospect ively r and omized to undergo CHS ( n = 18 ) or ITS ( n = 14 ) after esophagectomy . We compared clinical data , postoperative symptoms , and long-term survival in the two groups . Results The rates of anastomotic leak and stricture in the CHS and ITS groups were 16.7 % versus 7.1 % and 0 % versus 14.2 % , respectively , which do not represent significant differences . The respective rates of recurrent laryngeal nerve palsy were 38.8 % versus 7.1 % ( P < 0.05 ) , and proximal esophageal resection was 15 mm longer ( P < 0.05 ) in the CHS group . There were no significant differences in symptoms 6 months after surgery , or in the overall 5-year survival rates ( 72.2 % and 85.7 % , respectively ) . Conclusions The two methods of anastomosis yielded similar anastomotic outcomes . Although the incidence of recurrent laryngeal nerve injury was higher after CHS , and proximal esophageal resection was longer , this had little impact on postoperative symptoms and long-term survival By radioisotope technique , we studied the emptying function of the vagotomized intrathoracic stomach after esophagectomy for carcinoma of the esophagus in 24 patients , and compared it with the preoperative emptying function . The patients were r and omized into a control group ( no pyloroplasty ) and a study group ( pyloroplasty ) . Gastric emptying was delayed in both groups , postoperatively ; however , the delay was greater in the control group than in the study group . Therefore , vagotomy delays the emptying of the thoracic stomach , and this delay is not completely corrected by pyloroplasty OBJECTIVE For patients undergoing oncologic surgery , the quality of life ( QoL ) is generally accepted as an important outcome parameter in addition to long-term survival , mortality and complication rates . This study focussed on the QoL in patients after oesophagectomy for cancer , comparing the method of reconstruction ( narrow gastric tube vs whole stomach ) . METHODS In a prospect i ve r and omised single-centre study from 2007 to 2008 , 104 patients underwent oesophagectomy for cancer . To assess the QoL , a question naire in reference to the EORTC-QLQ-C30 and the QLQ-OES24 was administered at 3 weeks , 6 months and 1 year after surgery . Clinical data were collected prospect ively , and follow-up was performed regularly . RESULTS There were no significant differences between the narrow gastric tube group ( NGT group , n=52 ) and the whole-stomach group ( WS group , n=52 ) with regard to patient and cancer characteristics , operative procedure , postoperative intensive care unit ( ICU ) hospitalisation , and overall survival at 1 year . Regarding the postoperative complication , there were more cases of postoperative reflux oesophagitis and impairment of pulmonary function in the WS group ( P<0.05 ) . Regarding the QoL investigation , the scores of QoL dropped for all patients at 3 weeks after surgery . Slowly , recovery was found at both 6 months and 1 year in both groups . Patients in the NGT group reported significantly ( P<0.05 ) better scores of QoL at both 6 months and 1 year . CONCLUSIONS Patients who underwent gastric tube reconstruction develop less postoperative digestive tract complications , and have a quicker recovery and a better QoL during the follow-up period . Further investigation and data collection will allow the assessment of this procedure beyond 1 year after operation AIM To assess the influence of the route of conduit transposition after transhiatal oesophagectomy on the postoperative morbidity and mortality and late outcome at 6 months . METHODS Patients with oesophageal carcinoma , undergoing transhiatal oesophagectomy ( gastric conduit ) , were r and omized to either anterior or posterior route of conduit transposition . Patients with advanced tumour , distant metastasis , extensive invasion of the stomach , previous gastric surgery , any anterior mediastinal abnormality detected on preoperative imaging , ASA grade III/IV and poor preoperative pulmonary function were excluded . Intraoperative complications , postoperative morbidity and mortality and late outcomes were compared . RESULTS Of the 49 patients ( 34 men ) , 24 patients were r and omized to the anterior mediastinal route and 25 to the posterior . The mean duration of the operative procedure ( anterior : 235min ; posterior : 225min ) and the mean blood loss ( anterior : 531ml ; posterior : 538ml ) were not statistically different . The most common complications were pulmonary and cardiac and comparable in both groups . Four patients died postoperatively . At 6-month follow-up the incidence of dysphagia , anastomotic stricture , anastomotic recurrence , aspiration and reflux symptoms and weight gain were similar . CONCLUSIONS The route of conduit transposition did not affect the outcome . However , an individualized approach depending upon the operative findings , radicality of the procedure , and perceived need for postoperative adjuvant therapy may be useful Background For patients undergoing oncologic surgery , the quality of life ( QoL ) is generally accepted as an important outcome parameter in addition to long-term survival , mortality , and complication rates . Our study focused on outcome in terms of QoL in patients with esophageal cancer , comparing the sites of anastomosis ( cervical versus thoracic anastomosis ) . Methods In a prospect i ve longitudinal single-center study from 1998 to 2005 , 105 patients underwent surgery for esophageal cancer . To assess QoL the EORTC-QLQ-C-30 and a tumor-specific module were administered before surgery , at discharge , and three , six , 12 , and 24 months after surgery . Clinical data were collected prospect ively and follow-up was performed every six months . Results The histological type was squamous cell carcinoma in 51.4 % of the cases , adenocarcinoma in 41.9 % , and some other type in 6.7 % . There was no significant difference between cervical and thoracic anastomosis with regard to morbidity , mortality , and survival rates ( 30 % five-year survival rate ) , whereas tumor stage was a significant ( p < 0.001 ) prognostic factor . Most QoL scores dropped significantly below baseline in the early postoperative period . Even though they recovered slowly during the follow-up period , they never reached preoperative levels again . There was no statistically significant difference in any of the QoL scales between patients with a cervical or a thoracic anastomosis . Conclusions Esophageal resections are associated with significant deterioration of QoL , which persists during the follow-up period . The surgical technique and position of the esophagogastrostomy did not affect QoL deterioration BACKGROUND We evaluated the impact of the size of gastric tubes on tissue blood flow of the anastomotic site , the frequency of leakage and the postoperative nutritional status . METHODS Forty-four patients were r and omly allocated to either reconstruction using subtotal stomach ( n = 22 ) or to reconstruction using slender gastric tube ( n = 22 ) after esophagectomy . The tissue blood flow at the anastomotic site was measured . The postoperative nutritional status of 17 patients without recurrence was examined . Possible correlations between the type of esophageal substitute and the tendency to leakage as well as postoperative nutritional status were examined . RESULTS There was no significant difference in the tissue blood and the frequency of leakage between the types of gastric tubes . There was no significant difference noted between the two in the postoperative nutritional status at 6 and 12 months after operation . CONCLUSIONS The width of gastric tube has no impact on tissue blood flow , the frequency of leakage , and the postoperative nutritional status after esophagectomy BACKGROUND The optimal management of the pylorus during esophagogastrectomy is unknown . Pyloromyotomy and pyloroplasty cause early edema and risk long-term bile reflux ; however , the lack of pyloric drainage might risk early aspiration . METHODS We performed a retrospective study with a prospect i ve data base on patients with esophageal cancer or high- grade dysplasia who underwent Ivor-Lewis esophagogastrectomy . All had one surgeon and similar stomach tubularization , h and -sewn anastomoses , nasogastric tube duration , and postoperative prokinetic agents . Outcomes of postoperative gastric emptying , aspiration , and swallowing symptoms were compared . RESULTS Between January 1997 and June 2008 , there were 221 patients . Seventy-one patients had a pyloromyotomy , and gastric emptying judged on postoperative day 4 was delayed in 93 % ( 52 % had any morbidity and 14 % had respiratory morbidity ) . Fifty-four patients had no drainage procedure , and gastric emptying was delayed in 96 % ( 59 % had any morbidity and 22 % had respiratory morbidity ) . Twenty-eight patients underwent pyloroplasty , and 96 % had delayed gastric emptying ( 50 % had any morbidity and 32 % had respiratory morbidity ) . Sixty-eight patients had botulinum toxin injection into the pylorus . Gastric emptying was delayed in only 59 % ( P = .002 , 44 % had any morbidity and 13 % had respiratory morbidity ) . Hospital length of stay ( P = .015 ) and operative times ( P = .037 ) were shorter in the botulinum toxin group . Follow-up ( mean , 40 months ) showed symptoms of biliary reflux to be lowest in the botulinum toxin group ( P = .024 ) . CONCLUSION Injection of the pylorus with botulinum toxin at the time of esophagogastrectomy is safe and decreases operative time when compared with pyloroplasty or pyloromyotomy . In addition , it can improve early gastric emptying , decrease respiratory complications , shorten hospital stay , and reduce late bile reflux . A prospect i ve multi-institutional r and omized trial is needed Objective A prospect i ve r and omized trial was performed to compare retrosternal and posterior mediastinal gastric tube reconstruction with regard to postoperative function and quality of life . Methods Twenty-six patients were r and omly allocated to either retrosternal ( n = 14 ) or posterior mediastinal ( n = 12 ) reconstruction after gastric tube formation . Radionuclide transit studies were applied to obtain objective functional data and a st and ardized quality -of-life assessment was performed . Results Retrosternal reconstruction showed an increased morbidity ( 15 vs 13 major complications ) and mortality ( 14.2 vs 8.3 % ) . Radionuclide clearance
Output:
| Most studies showed superior passage of the gastric tube compared with the whole stomach .
Pyloric drainage is not significantly associated with the risk of developing delayed gastric emptying after esophagectomy . |
MS213914 | ***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 ascertain whether local anaesthetic use is of clinical benefit in nasal surgery , a prospect i ve double-blind r and omized controlled trial of topical bupivacaine on post-operative pain in patients packed after bilateral nasal surgery was carried out . Each patient received a bupivacaine-soaked and a saline-soaked Merocel pack , thereby acting as their own control . Power analysis ascertained the number of patients required to enter the trial to detect a statistically significant difference in pain . Fifty-seven patients completed the trial . Visual analogue scales determined the level of post-operative pain at different time points in each nostril . Less pain was demonstrated in nostrils containing bupivacaine-soaked packs compared with saline-soaked packs at two hours ( p < 0.0001 ) , four hours ( p = 0.0183 ) and six hours ( p = 0.0476 ) post-operatively . Although not statistically significant , less pain was noted on pack removal on the local anaesthetic sides . These results provide clinical -based evidence for the use of bupivacaine as a local anaesthetic in reducing pain following nasal surgery with packing Packing of the nasal cavity remains a common routine pre caution ary measure following septal surgery . The nasal pack and its removal 24 h later are often cited by patients as the most painful aspects of septal surgery . We present the results of a r and omized , prospect i ve controlled trial of the use of topical 5 % lignocaine ointment as a method of pain relief following post-operative nasal packing . Post-operative pain as measured using a visual analogue scale at 3 h post-operatively was halved in patients receiving a lignocaine impregnated nasal pack compared with those having a st and ard vaseline gauze pack ( P < 0.05 ) . Pain scores at 6 h post-operatively and at pack removal were also reduced , but these failed to reach significance . No patients suffered reactionary haemorrhage . The use of topical lignocaine ointment is safe and may have a place in the relief of pain due to post-operative nasal packing Background Septorhinoplasty is a traumatic procedure that is associated with epistaxis and postoperative pain . The primary objective of this r and omized double-blind controlled trial was to determine whether intranasal 5 % lidocaine plus naphazoline decreases postoperative pain and lessens the use of rescue analgesics . Methods After induction of general anesthesia and laryngeal topical anesthesia with 5 % lidocaine , 28 adult patients , scheduled to undergo septorhinoplasty , were r and omly assigned to one of two groups , either topical intranasal saline 20 ml ( control group ) or intranasal 5 % lidocaine plus naphazoline solution 0.2 mg ml−1 ( lidocaine group ) . The perioperative dose of sufentanil , the mean end-tidal concentration of isoflurane , and surgeon satisfaction with the operative field were recorded . In the lidocaine group , plasma lidocaine concentrations were sample d 15 , 20 , 25 , 35 , 45 , and 55 min after induction of anesthesia . Visual analogue scale pain scores were recorded 30 , 60 , 90 , and 120 min after the patients arrived in the postanesthesia care unit and 24 h after surgery . Consumption of morphine rescue analgesia and the occurrence of any side effects were recorded at the end of the 24-h study period . Results The intranasal lidocaine-naphazoline application decreased isoflurane requirements [ median values : 0.8 % ( 0.7–1.5 ) vs. 1.2 % ( 0.9–1.8 ) , respectively ; P = 0.04 ] and enhanced surgical conditions . Patients in the lidocaine group experienced less postoperative pain than the control group [ 1 h after surgery : median values of visual analogue scale : 0 ( 0–20 ) vs. 50 ( 30–80 ) , respectively ; P = 0.001 ] , and they required fewer doses of subcutaneous morphine . Total plasma concentrations of lidocaine remained below 4 μg ml−1 throughout the study period . Conclusions Intranasal lidocaine plus naphazoline is a simple and efficient technique for decreasing intra- and postoperative pain and for lessening rescue analgesic requirements in the postoperative period after septorhinoplasty . Toxic plasma concentrations of lidocaine were not reached . Résumé Context eLa rhinoseptoplastie est une procédure traumatisante associée à une épistaxis et des douleurs postopératoires . L’objectif primaire de cette étude r and omisée contrôlée à double insu était de déterminer si une solution intranasale de lidocaïne 5 % plus naphazoline réduisait la douleur postopératoire et diminuait l’utilisation d’analgésiques de sauvetage . MéthodeAprèsl’induction de l’anesthésie générale et une anesthésie laryngée topique avec de la lidocaïne 5 % , 28 patients adultes subissant une rhinoseptoplastie ont été r and omisés en deux groupes : 20 mL de solution saline intranasale topique ( groupe témoin ) ou solution de 5 % lidocaïne intranasale plus naphazoline 0,2 mg·mL−1 ( groupe lidocaïne ) . La dose périopératoire de sufentanil , la concentration d’isoflurane moyenne télo-expiratoire et la satisfaction du chirurgien quant au champ opératoire ont été enregistrés . Dans le groupe lidocaïne , les concentrations plasmatiques de lidocaïne ont été échantillonnées à 15 , 20 , 25 , 35 , 45 et 55 min aprèsl’induction de l’anesthésie . Les scores de douleur sur une échelle visuelle analogique ont été enregistrés 30 , 60 , 90 et 120 minutes aprèsl’arrivée des patients dans l’unité de soins postanesthésiques et 24 h après la chirurgie . La consommation de morphine en analgésie de sauvetage et la survenue d’effets secondaires ont été enregistrées à la fin de la période d’étude de 24 heures . RésultatsL’application de lidocaïne-naphazoline intranasale a diminué les besoins en isoflurane [ valeurs médianes : 0,8 % ( 0,7–1,5 ) vs 1,2 % ( 0,9–1,8 ) , respectivement ; P = 0,04 ] et amélioré les conditions chirurgicales . Les patients du groupe lidocaïne ont souffert de moins de douleurs postopératoires que ceux du groupe témoin [ une heure après la chirurgie : valeurs médianes sur l’échelle visuelle analogique : 0 ( 0–20 ) vs 50 ( 30–80 ) , respectivement ; P = 0,001 ] , et ont nécessité moins de doses de morphine sous-cutanée . Les concentrations plasmatiques totales de lidocaïne sont demeurées au dessous de 4 μg·mL−1 tout au long de la période d’étude . Conclusion La lidocaïne intranasale plus naphazoline est une technique simple et efficace pour diminuer la douleur per- et postopératoire et pour réduire les besoins en analgésiques de sauvetage durant la période postopératoire suivant une rhinoseptoplastie . Un niveau toxique de concentrations plasmatiques de lidocaïne n’a pas été atteint A double-blind investigation has been carried out using three different doses ( 20 , 35 and 50 mg ) of cocaine which were sprayed onto the nasal mucous membranes of forty-five patients for nasal surgery . The cocaine was administered after induction of general anaesthesia in all cases . The 20 mg dose of cocaine dissolved in 2 ml of saline without adrenaline was found to be safe and produced adequate nasal decongestion in the absence of other predominant factors . The efficacy of cocaine and its safety with regard to systemic absorption are assessed We aim ed to investigate the effects of local anesthetics soaked in Merocel nasal packs on hemorrhage and pain after septoplasty . The methodology includes a prospect i ve double-blind study that was conducted in patients undergoing septoplasty because of nasal septal deviation . The study included 143 patients . The patients were divided into four groups . Each group received 1 % lidocaine + 0.000625 % adrenalin , 0.375 % ropivacaine , 0.25 % bupivacaine as study groups or 0.9 % sodium chloride as a control group in their Merocel packs postoperatively . The local anesthetics or sodium chloride were reapplied at the eighth postoperative hour . Each patient was given a question naire where verbal analog score and amount of postoperative hemorrhage was noted . The statistical analysis was performed using two sided t test on each patient group at each time point . The results included the patients in the control group needing rescue drug most often . There was no statistically significant difference between bupivacaine and lidocaine plus adrenalin in the patients who requested rescue drug . The patients in the ropivacaine group requested rescue drug more frequently than the bupivacaine and lidocaine plus adrenalin groups . Bupivacaine group had significantly better pain scores versus control group at all intervals except for the first postoperative hour . The bupivacaine group had better pain scores versus ropivacaine and lidocaine plus adrenalin groups in the 4th , 8th and the 24th hours . The bupivacaine group had better pain scores versus lidocaine plus adrenalin in the 12th , 16th and the 20th hours . The ropivacaine group had significantly better pain scores versus control group in the 8th , 12th , 16th , 20th and 24th postoperative hours . The ropivacaine group scored better than lidocaine plus adrenalin group just in the 16th hour . The lidocaine plus adrenalin group had significantly better pain scores versus control group in 4th and 12th hours . There was no statistically significant difference between the study groups in terms of postoperative hemorrhage . We concluded that bupivacaine use in nasal surgery provides better analgesia at least in the first 8 h period and does not cause more bleeding . Topical bupivacaine application to nasal packs should be considered after septoplasty OBJECTIVES To compare the efficacy of Spiggle and Merocel foam packs following routine nasal surgery . DESIGN Prospect i ve , r and omised , single-blind , paired study . PARTICIPANTS Twenty adult patients undergoing elective nasal surgery . INTERVENTION At the end of nasal surgery patients were r and omised to have a Spiggle pack inserted in one nasal cavity and a Merocel pack in the other . Packs were removed the following morning . MAIN OUTCOME MEASURES The primary outcome measure was pain due to the presence of packs in the nose and pain associated with their removal . This was measured using a visual analogue scale . Secondary outcome measures were bleeding , crusting and adhesion formation . RESULTS Both packs were effective at preventing postoperative haemorrhage . Bleeding following removal was minimal . There were no significant differences between the packs in terms of levels of discomfort experienced 6 hours after surgery or the following morning prior to removal ( p = 0.3 and p = 0.3 respectively ) . However , the Spiggle foam pack caused significantly less pain on removal compared with the Merocel foam pack ( mean difference 1.4 ; 95 % CI 0.4 to 2.4 , p = 0.005 ) . There were no significant differences in terms of crust and adhesion formation . CONCLUSIONS In this study , both the Spiggle and Merocel foam nasal packs were well tolerated while in the nose . Both provided good postoperative haemostasis and were not associated with bleeding on removal . The Spiggle foam pack had the advantage of causing significantly less pain on removal . However , it must be borne in mind that in this study the Spiggle pack was more likely to be positioned in the non-incised nasal cavity , the side that would generally be expected to be associated with less pain BACKGROUND To maintain a high st and ard of patient care , it is essential to provide adequate pain management in patients who undergo nasal surgery . Levobupivacaine and ropivacaine are relatively new long-acting local anesthetics . OBJECTIVE The aim of this study was to compare the analgesic effect and blood loss of preincisional levobupivacaine HCl 0.25 % and ropivacaine HCl 0.375 % in patients undergoing septorhinoplasty . METHODS Sixty American Society of Anesthesiologists ( ASA ) I and II patients ( 18 - 55 years old ) who were scheduled for elective open technique septorhinoplasty under general anesthesia were recruited for this study . The anesthetic technique was st and ardized for both groups . Preoperative and postoperative hemoglobin levels were recorded for all patients . Patients were assigned r and omly to 1 of 2 study groups , and preincisional surgical field infiltration with 5 mL of 0.5 % levobupivacaine plus 5 mL of 0.9 % saline ( group L ; n = 30 ) or 5 mL of 0.75 % ropivacaine plus 5 mL of 0.9 % saline ( group R ; n = 30 ) was performed by the same surgeon . The degree of pain was measured by visual analogue scale ( VAS ) for pain and recorded at multiple time points in all patients after surg
Output:
| AUTHORS ' CONCLUSIONS The addition of local anaesthesia to nasal packs ( if these are being used ) following septal surgery may reduce postoperative pain within the first 12 hours , compared to nasal packing with a placebo added .
Evidence was lacking for other outcomes , including adverse effects .
There is a lack of evidence about the effects of local anaesthesia added to nasal packing compared to no nasal packing .
There is also a lack of evidence about the effects of local anaesthesia given by injection and the effects of sphenopalatine ganglion block |
MS213915 | ***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 Meropenem is a carbapenem antibiotic commonly used in critically ill patients to treat severe infections . The available pharmacokinetic ( PK ) data has been mostly obtained from healthy volunteers as well as from clinical studies addressing selected population s , often excluding the elderly and also patients with renal failure . Our aim was to study PK of meropenem in a broader population of septic critically ill patients . Methods We characterized the PK of meropenem in 15 critically ill patients during the first 36 hrs of therapy . Aditionally , whenever possible , we collected a second set of late plasma sample s after 5 days of therapy to evaluate PK intra-patient variability and its correlation with clinical course . Patients received meropenem ( 1 g every 8 hrs IV ) . Drug plasma profiles were determined by high-performance liquid chromatography . The PK of meropenem was characterized and compared with clinical parameters . Results Fifteen septic critically ill patients ( 8 male , median age 73 yrs ) were included . The geometric mean of the volume of distribution at the steady state (Vss)/weight was 0.20 ( 0.15 - 0.27 ) L/kg . No correlation of Vss/weight with severity or comorbidity scores was found . However the Sequential Organ Failure Assessment score correlated with the Vss/weight of the peripheral compartment ( r2 = 0.55 , p = 0.021 ) . The median meropenem clearance ( Cl ) was 73.3 ( 45–120 ) mL/min correlated with the creatinine ( Cr ) Cl ( r2 = 0.35 , p = 0.033).After 5 days ( N = 7 ) although Vss remained stable , a decrease in the proportion of the peripheral compartment ( Vss2 ) was found , from 61.3 (42.5 - 88.5)% to 51.7 (36.6 - 73.1)% . No drug accumulation was noted . Conclusions In this cohort of septic , unselected , critically ill patients , large meropenem PK heterogeneity was noted , although neither underdosing nor accumulation was found . However , Cr Cl correlated to meropenem Cl and the Vss2 decreased with patient ’s improvement The pharmacokinetics of apalcillin and piperacillin , each administered intravenously as a single 2-g dose , were compared in 10 volunteers in a r and omized study of crossover design using bioassay and high-pressure liquid chromatographic procedures . The concentrations of both penicillins in serum were determined over a period of 12 h and in urine over 24 h. Concentrations of apalcillin and piperacillin at the end of the 15-min infusion were similar ; however , at 8 h , concentrations of piperacillin were below measurable levels , whereas concentrations of apalcillin were still measurable at 10 h. Pharmacokinetic parameters were calculated according to a two-compartment open model . The area under the curve and the half-life for apalcillin were larger than for piperacillin . On the other h and , renal clearance of piperacillin was substantially greater than that of apalcillin . Of the apalcillin excreted via the kidneys , approximately one-fifth was eliminated as two microbiologically inactive penicilloic acid derivatives . The nonrenal clearance of apalcillin was 79 % of total clearance . Binding of apalcillin to serum protein was almost twice that of piperacillin STUDY OBJECTIVE To determine the appropriate compartmental and noncompartmental pharmacokinetic parameters for intravenous piperacillin and tazobactam . DESIGN Sequential selection of patients entered into a r and omized , open-label clinical efficacy trial . SETTING Los Angeles County-University of Southern California Medical Center . PARTICIPANTS Sequential sample of 18 patients admitted for intraabdominal infections and consented into a comparative antibiotic trial . INTERVENTIONS Patients received piperacillin 4 g plus tazobactam 500 mg by intravenous intermittent infusion every 8 hours . MEASUREMENTS AND MAIN RESULTS The estimated noncompartmental pharmacokinetic parameters ( mean + /- SD ) for piperacillin and tazobactam , respectively , were as follows : maximum concentration in plasma 218.7 + /- 48.9 micrograms/ml and 27.8 + /- 9.1 micrograms/ml ; half-life 1.07 + /- 0.22 hours and 1.00 + /- 0.27 hours ; elimination rate constant 0.67 + /- 0.13 hr-1 and 0.73 + /- 0.18 hr-1 ; area under the concentration-time curve from zero hour to infinity 288.5 + /- 71.25 mg.hr/L and 36.3 + /- 9.55 mg.hr/L ; total plasma clearance 14.75 + /- 3.93 L/hour and 14.78 + /- 4.39 L/hour ; renal clearance 5.69 + /- 1.94 L/hour and 7.85 + /- 3.37 L/hour ; volume of distribution at steady state 21.00 + /- 4.18 L and 22.47 + /- 8.27 L ; and mean residence time 1.72 + /- 0.29 hours and 1.79 + /- 0.35 hours . CONCLUSION Our findings were similar to those in other surgical patient models . The two-compartmental model best described piperacillin and tazobactam disposition in our patients . Bayesian analyses of the two-compartment models of piperacillin and tazobactam were able to predict trough , peak , and 2-hour postadministration levels without bias The pharmacokinetics of piperacillin and tazobactam were assessed after single-dose administration to 47 infants and children . Study subjects ranging in age from 2 months to 12 years were r and omized to receive one of two different doses of a piperacillin-tazobactam combination ( 8:1 ) : a low dose ( n = 23 ) of 50 and 6.25 mg of piperacillin and tazobactam per kg of body weight , respectively , or a high dose ( n = 24 ) of 100 and 12.5 mg , respectively . The pharmacokinetic behavior of tazobactam was very similar to that observed for piperacillin , supporting the use of these two agents in a fixed-dose combination . No differences in the pharmacokinetics of piperacillin or tazobactam were observed between the two doses administered . The elimination parameters half-life and total body clearance decreased and increased , respectively , with increasing age , whereas volume parameters ( volume of distribution and steady-state volume of distribution ) remained relatively constant for both compounds . The primary metabolite of tazobactam , metabolite M1 , was measurable in the plasma of 18 of the 47 study subjects ; 17 of these 18 subjects received the high doses . More than 70 % of the administered piperacillin and tazobactam doses were excreted unchanged in the urine over a 6-h collection period . These data combined with the known in vitro susceptibilities of a broad range of pediatric bacterial pathogens indicate that a dose of 100 mg of piperacillin and 12.5 of mg tazobactam per kg of body weight administered as a fixed-dose combination every 6 to 8 h would be appropriate to initiate clinical efficacy studies in infants and children for the treatment of systemic infections arising outside of the central nervous system . ABSTRACT Meropenem is used to manage postneurosurgical meningitis , but its population pharmacokinetics ( PPK ) in plasma and cerebrospinal fluid ( CSF ) in this patient group are not well-known . Our aims were to ( i ) characterize meropenem PPK in plasma and CSF and ( ii ) recommend favorable dosing regimens in postneurosurgical meningitis patients . Eighty-two patients were enrolled to receive meropenem infusions of 2 g every 8 h ( q8h ) , 1 g q8h , or 1 g q6h for at least 3 days . Serial blood and CSF sample s were collected , and concentrations were determined and analyzed via population modeling . Probabilities of target attainment ( PTA ) were predicted via Monte Carlo simulations , using the target of unbound meropenem concentrations above the MICs for at least 40 % of dosing intervals in plasma and at least of 50 % or 100 % of dosing intervals in CSF . A two-compartment model plus another CSF compartment best described the data . The central , inter central /peripheral , and inter central /CSF compartment clearances were 22.2 liters/h , 1.79 liters/h , and 0.01 liter/h , respectively . Distribution volumes of the central and peripheral compartments were 17.9 liters and 3.84 liters , respectively . The CSF compartment volume was fixed at 0.13 liter , with its clearance calculated by the observed drainage amount . The multiplier for the transfer from the central to the CSF compartment was 0.172 . Simulation results show that the PTAs increase as infusion is prolonged and as the daily CSF drainage volume decreases . A 4-hour infusion of 2 g q8h with CSF drainage of less than 150 ml/day , which provides a PTA of > 90 % for MICs of ≤8 mg/liter in blood and of ≤0.5 mg/liter or 0.25 mg/liter in CSF , is recommended . ( This study has been registered at Clinical Trials.gov under identifier NCT02506686 . Objectives To develop population pharmacokinetic ( PK ) models for piperacillin/tazobactam in neonates and infants of less than 2 months of age in order to determine the appropriate dosing regimen and provide a rational basis for the development of preliminary dosing guidelines suitable for this population . Methods A two-stage , open-label study was conducted in neonates and infants less than 2 months of age in the neonatal intensive care unit ( NICU ) . A total of 207 piperacillin and 204 tazobactam concentration – time data sets from 71 patients were analyzed using a nonlinear mixed-effect modeling approach ( NONMEM VII ) . PK models were developed for piperacillin and tazobactam . The final models were evaluated using both bootstrap and visual predictive checks . External model evaluations were made in 20 additional patients . Results For neonates and young infants less than 2 months of age , the median central clearance was 0.133 and 0.149 L/h/kg for piperacillin and tazobactam , respectively . Postmenstrual age ( PMA ) was identified as the most significant covariate on central clearance of piperacillin and tazobactam . However , the combination of current bodyweight ( BW ) and postnatal age proved to be superior to PMA alone . BW was the most important covariate for apparent central volume of distribution . Both internal and external evaluations supported the prediction of the final piperacillin and tazobactam PK models . The dosing strategy 44.44/5.56 mg/kg/dose piperacillin/tazobactam every 8 or 12 h evaluated in this study achieved the pharmacodynamic target ( free piperacillin concentrations > 4 mg/L for more than 50 % of the dosing interval ) in about 67 % of infants . Conclusions Population PK models accurately described the PK profiles of piperacillin/tazobactam in infants less than 2 months of age . The results indicated that higher doses or more frequent dosing regimens may be required for controlling infection in this population in NICU Background : The antibiotic meropenem is commonly administered in patients with severe sepsis and septic shock . We compared the pharmacokinetic , clinical , and bacteriological efficacies of continuous infusion of meropenem versus intermittent administration in such patients . Methods : Patients admitted to the Intensive Care Unit ( ICU ) with severe sepsis or septic shock who received meropenem were r and omly assigned to either the continuous ( n = 25 ) or intermittent groups ( n = 25 ) . The continuous group received a loading dose of 0.5 g of meropenem followed by a continuous infusion of 3 g/day ; the intermittent group received an initial dose of 1.5 g followed by 1 g for every 8 h. Clinical success , microbiological eradication , superinfection , ICU mortality , length of ICU stay , and duration of meropenem treatment were assessed . Serial plasma meropenem concentrations for the first and third dosing periods ( steady state ) were also measured . Results : Clinical success was similar in both the continuous ( 64 % ) and intermittent ( 56 % ) groups ( P = 0.564 ) ; the rates of microbiological eradication and superinfection ( 81.8 % vs. 66.7 % [ P = 0.255 ] and 4 % vs. 16 % [ P = 0.157 ] , respectively ) showed improvement in the continuous group . The duration of meropenem treatment was significantly shorter in the continuous group ( 7.6 vs. 9.4 days ; P = 0.035 ) , where a better steady-state concentration was also achieved . Peak and trough concentrations were significantly different between the continuous and intermitt
Output:
| PK parameters from critically ill population s were reported with wider confidence intervals than those in healthy volunteers , indicating greater PK variability in critical illness .
The st and ard allometric size and sigmoidal maturation model adequately described increasing clearance in neonates , and a sigmoidal model was also used to describe decline in older age .
Changes in volume of distribution were well described by the st and ard allometric model , although amoxicillin data suggested a relatively higher volume of distribution in neonates .
Critical illness is associated with greater PK variability than in healthy volunteers . |
MS213916 | ***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 population -based r and omized intervention trial for the prevention of conduct problems ( i.e. , oppositional defiant disorder and conduct disorder ) is described . The LIFT ( Linking the Interests of Families and Teachers ) intervention was design ed for all first- and fifth- grade elementary school boys and girls and their families living in at-risk neighborhoods characterized by high rates of juvenile delinquency . The 10-week intervention strategy was carefully targeted at proximal and malleable antecedents in three social domains that were identified by a developmental model of conduct problems . From 12 elementary schools , 671 first and fifth grade rs and their families participated either in the theory-based universal preventive intervention or in a control condition . The intervention consisted of parent training , a classroom-based social skills program , a playground behavioral program , and systematic communication between teachers and parents . A multiple measure assessment strategy was used to evaluate participant satisfaction and participation , fidelity of implementation , and the immediate impacts of the program on targeted antecedents This study reports on aggressive outcomes from a cluster r and omized trial of the Promoting Alternative Thinking Strategies ( PATHS ) curriculum . Fourteen elementary schools were r and omly assigned to intervention or control condition and third grade students were followed through the fifth grade . Teacher and self-reports of student aggression , conduct problems , delinquency , acting out problems , and social information processing ( SIP ) variables were collected . Linear change for each of the SIP variables was noted with control students demonstrating increased normative beliefs about aggression , increased aggressive social problem solving , increased hostile attribution bias , and increased aggressive interpersonal negotiation strategies over time while PATHS students remained relatively stable . Teachers reported significant curvilinear change in student aggression , conduct problems , and acting out behavior problems ; all favoring PATHS students OBJECTIVE To report experimental impacts of a universal , integrated school-based intervention in social-emotional learning and literacy development on change over 1 school year in 3rd- grade children 's social-emotional , behavioral , and academic outcomes . METHOD This study employed a school-r and omized , experimental design and included 942 3rd- grade children ( 49 % boys ; 45.6 % Hispanic/Latino , 41.1 % Black/African American , 4.7 % non-Hispanic White , and 8.6 % other racial/ethnic groups , including Asian , Pacific Isl and er , Native American ) in 18 New York City public elementary schools . Data on children 's social-cognitive processes ( e.g. , hostile attribution biases ) , behavioral symptomatology ( e.g. , conduct problems ) , and literacy skills and academic achievement ( e.g. , reading achievement ) were collected in the fall and spring of 1 school year . RESULTS There were main effects of the 4Rs Program after 1 year on only 2 of the 13 outcomes examined . These include children 's self-reports of hostile attributional biases ( Cohen 's d = 0.20 ) and depression ( d = 0.24 ) . As expected based on program and developmental theory , there were impacts of the intervention for those children identified by teachers at baseline with the highest levels of aggression ( d = 0.32 - 0.59 ) on 4 other outcomes : children 's self-reports of aggressive fantasies , teacher reports of academic skills , reading achievement scaled scores , and children 's attendance . CONCLUSIONS This report of effects of the 4Rs intervention on individual children across domains of functioning after 1 school year represents an important first step in establishing a better underst and ing of what is achievable by a schoolwide intervention such as the 4Rs in its earliest stages of unfolding . The first-year impacts , combined with our knowledge of sustained and exp and ed effects after a second year , provide evidence that this intervention may be initiating positive developmental cascades both in the general population of students and among those at highest behavioral risk . ( PsycINFO Data base Record ( c ) 2010 APA , all rights reserved ) The Media Ready Program was design ed as a middle school , media literacy education , preventive intervention program to improve adolescents ' media literacy skills and reduce their intention to use alcohol or tobacco products . In a short-term efficacy trial , schools in North Carolina were r and omly assigned to conditions ( Media Ready : n = 214 ; control : n = 198 ) . Boys in the Media Ready group reported significantly less intention to use alcohol in the future than did boys in the control group . Also , students in the Media Ready group who had used tobacco in the past reported significantly less intention to use tobacco in the future than did students in the control group who had previously used tobacco . Multilevel multiple mediation analyses suggest that the set of logical analysis Message Interpretation Processing variables mediated the program 's effect on students ' intentions to use alcohol or tobacco in the future OBJECTIVE To test the efficacy of 2 programs design ed to reduce high-risk behaviors among inner-city African American youth . DESIGN Cluster r and omized trial . SETTING Twelve metropolitan Chicago , Ill , schools and the communities they serve , 1994 through 1998 . PARTICIPANTS Students in grade s 5 through 8 and their parents and teachers . INTERVENTIONS The social development curriculum ( SDC ) consisted of 16 to 21 lessons per year focusing on social competence skills necessary to manage situations in which high-risk behaviors occur . The school/community intervention ( SCI ) consisted of SDC and school-wide climate and parent and community components . The control group received an attention-placebo health enhancement curriculum ( HEC ) of equal intensity to the SDC focusing on nutrition , physical activity , and general health care . MAIN OUTCOME MEASURES Student self-reports of violence , provocative behavior , school delinquency , substance use , and sexual behaviors ( intercourse and condom use ) . RESULTS For boys , the SDC and SCI significantly reduced the rate of increase in violent behavior ( by 35 % and 47 % compared with HEC , respectively ) , provoking behavior ( 41 % and 59 % ) , school delinquency ( 31 % and 66 % ) , drug use ( 32 % and 34 % ) , and recent sexual intercourse ( 44 % and 65 % ) , and improved the rate of increase in condom use ( 95 % and 165 % ) . The SCI was significantly more effective than the SDC for a combined behavioral measure ( 79 % improvement vs 51 % ) . There were no significant effects for girls . CONCLUSIONS Theoretically derived social-emotional programs that are culturally sensitive , developmentally appropriate , and offered in multiple grade s can reduce multiple risk behaviors for inner-city African American boys in grade s 5 through 8 . The lack of effects for girls deserves further research Six schools were r and omly assigned to a multilevel bullying intervention or a control condition . Children in Grade s 3 - 6 ( N=1,023 ) completed pre- and posttest surveys of behaviors and beliefs and were rated by teachers . Observers coded playground behavior of a r and om sub sample ( n=544 ) . Hierarchical analyses of changes in playground behavior revealed declines in bullying and argumentative behavior among intervention-group children relative to control-group children , increases in agreeable interactions , and a trend toward reduced destructive byst and er behavior . Those in the intervention group reported enhanced byst and er responsibility , greater perceived adult responsiveness , and less acceptance of bullying/aggression than those in the control group . Self-reported aggression did not differ between the groups . Implication s for future research on the development and prevention of bullying are discussed This study examined the effects of the Positive Action ( PA ) programme in Chicago Public Schools on problem behaviours among a cohort of elementary school students from grade three through grade five . Using a matched-pair , r and omised control design with 14 elementary schools , approximately 510 fifth- grade rs self-reported lifetime substance use , serious violence-related behaviour , and current bullying and disruptive behaviours . Three-level ( i.e. students nested within schools within school pairs ) overdispersed Poisson models were used to examine programme effects on the number of items endorsed for each of the four outcomes . Findings indicated that students in the intervention endorsed 31 % fewer substance use behaviours ( incidence rate ratio [ IRR ] = 0.69 ) , 37 % fewer violence-related behaviours ( IRR = 0.63 ) and 41 % fewer bullying behaviours ( IRR = 0.59 ) , respectively , compared to students in the control schools . Reduction in reported disruptive behaviours was of a similar magnitude ( 27 % , IRR = 0.73 ) , but was not statistically significant . These results replicate findings of an earlier r and omised trial of the PA programme and extend evidence of its effectiveness to youth attending large urban school systems Study objective : The aim of this study was to determine the effect of a multilevel school based intervention on adolescents ’ emotional wellbeing and health risk behaviours . Design : School based cluster r and omised controlled trial . Students were surveyed using laptop computers , twice in the first year of intervention and annually thereafter for a further two years . Setting : Secondary schools . Participants : 2678 year 8 students ( 74 % ) participated in the first wave of data collection . Attrition across the waves was less than 3 % , 8 % , and 10 % respectively with no differential response rate between intervention and control groups at the subsequent waves ( 98 % v 96 % ; 92 % v 92 % , and 90 % v 89 % respectively ) . Main results : A comparatively consistent 3 % to 5 % risk difference was found between intervention and control students for any drinking , any and regular smoking , and friends ’ alcohol and tobacco use across the three waves of follow up . The largest effect was a reduction in the reporting of regular smoking by those in the intervention group ( OR 0.57 , 0.62 , and 0.72 at waves 2 , 3 , and 4 respectively ) . There was no significant effect of the intervention on depressive symptoms , and social and school relationships . Conclusions : While further research is required to determine fully the processes of change , this study shows that a focus on general cognitive skills and positive changes to the social environment of the school can have a substantial impact on important health risk behaviours PURPOSE To evaluate the impact of the Second Step : Student Success Through Prevention ( SS-SSTP ) Middle School Program on reducing youth violence including peer aggression , peer victimization , homophobic name calling , and sexual violence perpetration and victimization among middle school sixth- grade students . METHODS The study design was a nested cohort ( sixth grade rs ) longitudinal study . We r and omly assigned 18 matched pairs of 36 middle schools to the SS-SSTP or control condition . Teachers implemented 15 weekly lessons of the sixth- grade curriculum that focused on social emotional learning skills , including empathy , communication , bully prevention , and problem-solving skills . All sixth grade rs ( n = 3,616 ) in intervention and control conditions completed self-report measures assessing verbal/relational bullying , physical aggression , homophobic name calling , and sexual violence victimization and perpetration before and after the implementation of the sixth- grade curriculum . RESULTS Multilevel analyses revealed significant intervention effects with regard to physical aggression . The adjusted odds ratio indicated that the intervention effect was substantial ; individuals in intervention schools were 42 % less likely to self-report physical aggression than students in control schools . We found no significant intervention effects for verbal/relational bully perpetration , peer victimization , homophobic teasing , and sexual violence . CONCLUSIONS Within a 1-year period , we noted significant reductions in self-reported physical aggression in the intervention schools . Results suggest that SS-SSTP holds promise as an efficacious prevention program to reduce physical aggression in adolescent youth We report results from a group-r and omized trial of a prevention program aim ed at preventing bullying and other aggressive behaviors . Fourth grade classrooms at 28 public elementary schools were assigned to receive selected modules of the Youth Matters prevention curriculum or to a no-treatment control condition . Cross-classified multilevel models were fitted to four waves of data collected over 2 years to test the effect of the intervention on self-reported bullying and bully victimization . No systematic change in bullying other students was observed . In a continuous outcome growth model , bully victim scale scores declined over the course of the study and the rate of decline in victimization was significantly higher in experimental schools relative to control schools . But the results from binary outcome growth models indicate no significant treatment effects on bully status or bully victim status over time . Implication s of findings for the implementation of anti-bullying strategies in urban public school setting s are discussed 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
Output:
| Evidence was concentrated in KS2 , with few evaluations in KS3 or KS4 , and evaluations had few consistent effects ; evaluations in KS3 and KS4 did not suggest effectiveness .
Evaluations did not shed light on the value of different approaches to integration |
MS213917 | ***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 effect of a supervised home-based exercise program on the recurrence and severity of gestational diabetes mellitus ( GDM ) together with other aspects of maternal health and obstetric and neonatal outcomes . METHODS : This r and omized controlled trial allocated women with a history of GDM to an exercise intervention ( 14-week supervised home-based stationary cycling program ) or to a control group ( st and ard care ) at 13±1 weeks of gestation . The primary outcome was a diagnosis of GDM . Secondary outcomes included maternal fitness , psychological well-being , and obstetric and neonatal outcomes . A sample size of 180 ( 90 in each group ) was required to attain 80 % power to detect a 40 % reduction in the incidence of GDM . RESULTS : Between June 2011 and July 2014 , 205 women provided written consent and completed baseline assessment s. Of these , 33 ( 16 % ) were subsequently excluded as a result of an elevated baseline oral glucose tolerance test ( OGTT ) , leaving 172 r and omized to exercise ( n=85 ) or control ( n=87 ) . Three women miscarried before the assessment of outcome measures ( control=2 ; exercise=1 ) . All remaining women completed the postintervention OGTT . The recurrence rate of GDM was similar between groups ( control 40 % [ n=34 ] ; exercise 40.5 % [ n=34 ] ; P=.95 ) and the severity of GDM at diagnosis was unaffected by the exercise program with similar glucose and insulin responses to the OGTT ( glucose 2 hours post-OGTT 7.7±1.5 compared with 7.6±1.6 mmol/L ; P>.05 ) . Maternal fitness was improved by the exercise program ( P<.01 ) and psychological distress was reduced ( P=.02 ) . There were no differences in obstetric and neonatal outcomes between groups ( P>.05 ) . CONCLUSION : Supervised home-based exercise started at 14 weeks of gestation did not prevent the recurrence of GDM ; however , it was associated with important benefits for maternal fitness and psychological well-being . CLINICAL TRIAL REGISTRATION : Clinical Trials.gov , https:// clinical trials.gov , NCT01283854 Recent guidelines on exercise for weight loss and weight maintenance include resistance training as part of the exercise prescription . Yet few studies have compared the effects of similar amounts of aerobic and resistance training on body mass and fat mass in overweight adults . STRRIDE AT/RT , a r and omized trial , compared aerobic training , resistance training , and a combination of the two to determine the optimal mode of exercise for obesity reduction . Participants were 119 sedentary , overweight or obese adults who were r and omized to one of three 8-mo exercise protocol s : 1 ) RT : resistance training , 2 ) AT : aerobic training , and 3 ) AT/RT : aerobic and resistance training ( combination of AT and RT ) . Primary outcomes included total body mass , fat mass , and lean body mass . The AT and AT/RT groups reduced total body mass and fat mass more than RT ( P < 0.05 ) , but they were not different from each other . RT and AT/RT increased lean body mass more than AT ( P < 0.05 ) . While requiring double the time commitment , a program of combined AT and RT did not result in significantly more fat mass or body mass reductions over AT alone . Balancing time commitments against health benefits , it appears that AT is the optimal mode of exercise for reducing fat mass and body mass , while a program including RT is needed for increasing lean mass in middle-aged , overweight/obese individuals PURPOSE The purpose of the study was to determine the effect of a home-based cycling program for women with a recent diagnosis of gestational diabetes mellitus ( GDM ) on aerobic fitness , weight gain , self-reported mobility , attitude , and intentions toward maternal exercise , and obstetric and neonatal outcomes . METHODS Forty women ( mean ± SD , 28.8 ± 0.9-wk gestation ) were r and omized to either a supervised , home-based exercise program , combining continuous steady-state and interval cycling at various intensities , in combination with unsupervised moderate intensity aerobic activity and conventional diabetic management ( EX ; n = 20 ) or to conventional management alone ( CON ; n = 20 ) . The program began following diagnosis until week 34 of pregnancy ( mean ± SD duration of training , 6 ± 1 wk ) . RESULTS Mean compliance to the training program was 96 % . Maternal aerobic fitness , and attitude and intentions toward exercise were improved in response to the home-based exercise intervention compared with CON ( P < 0.05 ) . No differences were observed between the groups with respect to maternal weight gain or obstetric and neonatal outcomes ( P > 0.05 ) . CONCLUSION A home-based exercise program of 6 ± 1 wk in duration commenced after diagnosis of GDM can improve aerobic fitness and attitude and intentions toward exercise , with no adverse effect on maternal and neonatal pregnancy outcomes BACKGROUND Exercise may influence glucose metabolism during pregnancy . We examined the effect of exercise intensity and duration on capillary glucose responses in pregnant women at low and high risk for gestational diabetes mellitus ( GDM ) who followed a modified GDM meal plan . METHODS R and omization occurred at study entry ( 16 - 20 weeks ' gestation ) into a low-intensity [ 30 % heart rate reserve , low risk-30%I , n = 12 ; high risk-30%I , n = 11 ] or vigorous-intensity ( 70 % heart rate reserve , low risk-70%I , n = 12 ; R-70%I , n = 11 ) exercise program with similar nutritional control . Exercise consisted of walking three to four times a week , gradually increasing time from 25 to 40 min/session . Free-living capillary glucose concentrations were measured once a week pre-exercise and post-exercise . RESULTS Capillary glucose responses to exercise were strongly influenced by an interaction between GDM risk , exercise duration and exercise intensity ( p = 0.006 ) . Decreases in glucose concentrations were observed after 25 ( 4 ± 13 % ) , 35 ( 21 ± 12 % ) and 40 min ( 15 ± 18 % ) of walking in high risk-30%I women , with the most noticeable decline after 35 and 40 min . In the high risk-70%I , glucose concentrations decreased significantly only after 25 ( 22 ± 14 % ) and 35 min ( 7 ± 23 % ) and increasing the exercise time attenuated glucose concentrations decline . In low risk women , regardless of exercise intensity and duration , decreases in glucose concentrations were significant and similar . CONCLUSION To achieve the best decline in glucose concentrations , pregnant women who follow a modified GDM meal plan should walk for 25 min/session at vigorous intensity or for 35 - 40 min/session at low intensity if they are at risk for GDM and for at least 25 min at either low or vigorous intensity if they are at low risk for GDM Objective To examine the effectiveness of a partially homebased , moderate-intensity aerobic exercise program for women with gestational diabetes . Methods This was a r and omized experimental design . Thirty-three women with gestational diabetes were r and omly assigned to the exercise or the no-exercise group . Subjects underwent hemoglobin A1C assay and submaximal cycle ergometer fitness tests at baseline and at study conclusion . Subjects kept diaries of home fasting and 2-hour postpr and ial blood glucose determinations . Exercise subjects were asked to exercise for 30 minutes three to four times weekly at 70 % of estimated maximal heart rate for the weeks of study participation . Two exercise sessions weekly were supervised by the investigator , and two were unsupervised at home . Control-group subjects were asked to maintain their current activity level . Results Daily fasting and postpr and ial blood glucose levels , hemoglobin A1C , incidence of exogenous insulin therapy , and incidence of newborn hypoglycemia were not different between the groups . There was a training effect in the exercise group ( P = .005 ) but not in the control group ( P = .25 ) . A significant decline in daily grams of carbohydrate consumed was observed in the control group ( P = .03 ) , but not in the exercise group ( P = .97 ) . No complications were found in the subjects who exercised . Conclusions A partially home-based exercise program did not reduce blood glucose levels , but did result in a modest increase in cardiorespiratory fitness . The intervention appeared safe OBJECTIVE Available insulin sensitivity ( IS ) methods based on the oral glucose tolerance test ( OGTT ) are empirical . We used a glucose-insulin model to derive an OGTT-based IS ( oral glucose insulin sensitivity [ OGIS ] ) index , which predicts glucose clearance in a glucose clamp . We vali date d OGIS against clamp data . RESEARCH DESIGN AND METHODS OGIS requires glucose and insulin concentrations from a 75-g OGTT at 0 , 2 , and 3 h ( 3-h OGTT ) or at 0 , 1.5 , and 2 h ( 2-h OGTT ) . The formula includes six constants optimized to match the clamp results . For this purpose , 15 lean nondiabetic subjects ( BMI < 25 kg/m2 ) , 38 obese nondiabetic subjects ( BMI > 25 kg/m2 ) , and 38 subjects with type 2 diabetes r and omly underwent an OGTT and a 120 mU x min(-1 ) x m(-2 ) insulin infusion euglycemic clamp . Glucose clearance ( Cl CLAMP ) , calculated as the ratio of glucose infusion to concentration during the last hour of the clamp , was compared with OGIS . OGIS was also tested on an independent group of 13 subjects with impaired glucose tolerance ( IGT ) . RESULTS OGIS and Cl CLAMP were correlated in the whole group ( R = 0.77 , P < 0.0001 ) , in the subgroups ( lean : R = 0.59 ; obese : R = 0.73 ; type 2 diabetes : R = 0.49 ; P < 0.02 ) , and in the independent IGT group ( R = 0.65 , P < 0.02 ) . Reproducibility of OGIS and Cl CLAMP were similar ( coefficients of variation : OGIS 7.1 % , Cl CLAMP 6.4 % ) . OGIS was as effective as Cl CLAMP in discriminating between groups ( for OGIS , lean vs. obese : 440 + /- 16 vs. 362 + /- 11 ml x min(-1 ) x m(-2 ) , p < 0.001 ; lean vs. type 2 diabetes : 440 + /- 16 vs. 239 + /- 7 , P < 0.0001 ; obese vs. type 2 diabetes : 362 + /- 11 vs. 239 + /- 7 , P < 0.0001 ; results were similar for Cl CLAMP ) . The relationships between IS and BMI , fasting plasma insulin , and insulin secretion ( calculated from the OGTT insulin concentration ) were examined . OGIS yielded results similar to Cl CLAMP and fully consistent with established physiological principles . The performance of the index for the 3-h and 2-h OGTT was similar . CONCLUSIONS OGIS is an index of IS in good agreement with the clamp . Because of its simplicity ( only three blood sample s required ) , this method has potential use for clinical investigation including large-scale epidemiological studies AIM The significant deterioration of insulin sensitivity and glucose tolerance during pregnancy can have serious health implication s for both the pregnant woman and her baby . Although it is well established that regular exercise benefits insulin sensitivity in the nonpregnant population , the effect on glucose tolerance in obese pregnant women is not known . The purpose of this study was to investigate the effect of a supervised 10-week , home-based , exercise programme , beginning at week 18 of gestation , on glucose tolerance and aerobic fitness in previously sedentary obese women . METHODS Twelve sedentary obese women were r and omized into an exercise ( EX ; n=6 ) or control ( CON ; n=6 ) group at 18 weeks of gestation . Those r and omized to EX engaged in 10 weeks of supervised home-based exercise ( three sessions a week of stationary cycling ) , while those in the CON group maintained their usual daily activity . Their glucose and insulin responses to an oral glucose tolerance test ( OGTT ) , as well as their aerobic fitness , were assessed both pre- and postintervention . RESULTS Reduced glucose tolerance in the CON , but not EX , group was indicated by a tendency postintervention towards higher blood glucose levels at 1h of the OGTT ( P=0.072 ) . Furthermore , at 2h of the postintervention OGTT , blood glucose tended to remain elevated from baseline in the CON ( P=0.077 ) . There was also a trend towards increased fitness in the EX ( P=0.064 ) , but not the CON group . CONCLUSION Regular aerobic exercise begun during pre
Output:
| The interventions showed consistently that requirements of insulin therapy , dosage , and latency to administration were improved in the exercise groups .
Less consistent results were observed for capillary blood glucose measurements ; however , both modalities and combination of modalities were effective at improving blood glucose control in already diagnosed patients and pregnant women with obesity .
Conclusion Exercising three times per week for 40 - 60 min at 65 - 75 % age-predicted heart rate maximum using cycling , walking or circuit training as a modality improved glycaemic control in GDM patients and reduced incidence of GDM in pregnant women with obesity . |
MS213918 | ***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 The aim of this exploratory study was to investigate changes in pain , disability , and muscle activation patterns in patients with chronic whiplash-associated disorder ( WAD ) after 4 weeks of myofeedback training . Methods Eleven WAD patients received ambulatory myofeedback training , during which upper trapezius muscle activation and relaxation were continuously recorded and processed for 4 weeks . Feedback was provided when muscle relaxation was insufficient . Pain in neck , shoulders , and upper back ( Visual Analogue Scale ) , disability ( Neck Disability Index ) , and muscle activation patterns during rest , typing , and stress tasks ( surface electromyography ) were assessed before and after the 4 weeks of training . Results Pain intensity decreased after 4 weeks of training . Clinical ly relevant changes were found with regard to pain in the neck and upper back region ( 55 % of the patients ) , right shoulder ( 64 % ) , and left shoulder ( 18 % ) . A trend for decreased disability was found which was clinical ly relevant in 36 % of the patients . A remarkable reduction was found in the Neck Disability Index items concerning headache and lifting weights . Overall , muscle activation was lower and muscle relaxation was higher after the training period with the largest differences during rest . Clinical ly relevant changes in surface electromyography parameters were found in a minority of patients . Conclusion Four weeks of ambulant training may be beneficial in reducing pain and disability levels and normalizing muscle activation patterns in chronic WAD patients . A r and omized-controlled study is recommended to further explore the effects of myofeedback training PURPOSE Although daytime clenching is believed to be one of the oral parafunctions leading to dental problems , a treatment strategy has not yet been devised . Electromyogram ( EMG ) biofeedback training was performed to ascertain its effect on the regulation of daytime clenching behavior . MATERIAL S AND METHODS Twenty subjects ( mean age , 30.9±5.6 years ) who had mild to moderate masticatory muscle pain with daytime clenching behavior were r and omly divided into either a biofeedback group ( BF ) or control group ( CO ) . Subjects were fitted with a hearing-aid-shaped EMG recording and biofeedback apparatus which was used to record EMG data under natural conditions from the temporal muscle , continuously for five hours on four consecutive days . EMG data on Days 1 and 4 were recorded without biofeedback as pre-test and post-test , respectively , and on Days 2 and 3 , subjects in the BF group noticed their clenching behaviors via an alert sound from the EMG biofeedback apparatus . No alert sound was given for the CO group throughout the recording sessions . RESULTS There was no significant difference in the number of clenching events for five hours between the BF group ( 4.6±2.5 ) and CO group ( 4.6±0.9 ) on Day 1 , however a significant decrease was found in the BF group between Day 1 ( 4.6±2.5 ) and Day 4 ( 2.4±1.7 ; P<0.05 ) . CONCLUSION Daytime clenching was reduced in the short-term with the help of an EMG biofeedback system under natural circumstances . Further research is needed to confirm a long-lasting effect There is emerging evidence that feedback techniques based on contingent electrical stimulation ( CES ) have an inhibitory effect on the electromyogram ( EMG ) activity of jaw-closing muscles and therefore could be useful in the management of sleep bruxism . This polysomnographic ( PSG ) study was design ed to investigate the effect of CES on PSG parameters in subjects with self-reported bruxism . Fourteen subjects underwent a full PSG investigation in the laboratory for three consecutive nights - one night of adaptation , one night without CES , and one night with CES - in a r and omized order . During all sessions the EMG activity was recorded by a portable feedback device from the temporalis muscle . An electrical pulse , which was adjusted to a moderate , but non-painful , intensity , was applied to subjects during the session with CES , if jaw-muscle activity was detected . The total sleep time , the number of micro-arousals per hour of sleep , the time spent in sleep stages 3 and 4 and in rapid eye movement ( REM ) sleep , and the number of periodic limb movements , were not influenced by CES . The number of EMG episodes per hour of sleep during the nights with and without CES was not significantly different . The present study suggests that CES at non-painful intensities does not cause major arousal responses in any of the sleep parameters assessed in this study & NA ; Temporom and ibular disorders ( TMD ) represent a group of chronic painful conditions involving the muscles of mastication and the temporom and ibular joint . Several studies have reported that TMD is associated with enhanced sensitivity to experimental pain . Twenty‐three TMD subjects and 24 pain‐free matched control subjects participated in a set of studies which were design ed to evaluate whether the temporal integrative aspects of thermal pain perception are altered in TMD patients compared with control subjects . Specifically , we have examined in both TMD patients and in age‐ and gender‐matched control subjects : ( 1 ) the time‐course and magnitude of perceived pain evoked by the application of sustained 7‐s noxious thermal stimuli ( 45–48 ° C ) to the face and forearm , ( 2 ) the central summation of C‐fiber‐mediated pain produced by applying brief trains of noxious heat pulses to the skin overlying the ventral aspect of the right palm and ( 3 ) the ability to discriminate small increments in noxious heat applied to facial and volar forearm skin . Data collected from these studies indicate that TMD patients show enhanced temporal integration of thermal pain compared with control subjects . TMD patients show greater thermal C‐fiber‐mediated temporal summation than pain‐free subjects and they report a greater magnitude of sustained noxious heat pulses applied to either the face or the forearm than control subjects . In contrast to these findings , TMD and pain‐free subjects are equally able to discriminate and detect small increments of heat applied to noxious adapting temperatures . These findings suggest that the augmented temporal integration of noxious stimuli may result from alterations in central nervous system processes which contribute to the enhanced pain sensitivity observed in TMD patients & NA ; The pathophysiological mechanisms of myofascial temporom and ibular disorders ( TMD ) are still under investigation . The hypothesis that TMD pain is caused by a generalized sensitization of higher order neurons in the nociceptive pathways combined with a decreased efficacy of endogenous inhibitory systems has recently gained support in the literature . This study was design ed to further investigate the somatosensory sensibility within and outside the craniofacial region . Twenty‐two patients fulfilled the research diagnostic criteria for TMD for myofascial pain ( Dworkin and LeResche , J Craniom and ib Disord Facial Oral Pain 6 ( 1992 ) 301 ) and 21 age‐ and sex‐matched subjects served as a control group . The somatosensory sensibility to a deep tonic input was tested by st and ardized infusions of hypertonic saline into the masseter and anterior tibialis muscle . Furthermore , pressure pain thresholds ( PPTs ) and heat pain thresholds ( HPTs ) were assessed with phasic stimuli at the same sites before and following the infusions . Myofascial TMD patients reported infusion of hypertonic saline to be more painful on 10 cm visual analogue scales ( peak pain 8.8±0.4 cm ) than control subjects ( 6.8±0.5 cm , t‐test : P=0.003 ) in the masseter but not in the anterior tibialis ( 7.4±0.5 vs. 6.6±0.5 cm , P=0.181 ) . The perceived area of experimental masseter pain measured on drawings was marginally larger in TMD patients ( 2.6±0.5 arbitrary units ( a.u . ) ) than in control subjects ( 1.4±0.2 a.u . , Mann – Whitney : P=0.048 ) but no differences were observed for the anterior tibialis ( P=0.771 ) . The PPTs were lower in the myofascial TMD patients compared to the control group , both in the masseter ( analysis of variance ( ANOVA ) : P=0.002 ) and in the anterior tibialis ( P=0.005 ) , whereas there were no significant differences in HPT ( ANOVAs : P=0.357 , P=0.101 ) . There were no significant correlations between measures of somatosensory sensibility and measures of clinical pain intensity , pain duration , grade d chronic pain scores or somatization or depression scores ( Pearson : R<0.304 , P>0.172 ) . The present study in a well‐defined group of myofascial TMD patients found that the responsiveness to both tonic and phasic deep stimuli , but not to phasic superficial inputs at the pain threshold level , in the craniofacial region was higher compared with a control group . These findings suggest that myofascial TMD pain is associated with a facilitation of stimulus‐evoked pain primarily , but not exclusively related to the painful region AIMS To determine whether an intervention reduces oromotor activity and masticatory muscle pain in myofascial temporom and ibular disorder ( M/TMD ) patients with high levels of masticatory muscle activity associated with sleep bruxism . METHODS Fourteen women with M/TMD and prior polysomnographic evidence consistent with sleep bruxism participated in a 10-week single-group pre-test/ post-test mechanistic clinical trial . A 2-week period of baseline monitoring of individually biocalibrated electromyographic ( EMG ) events associated with sleep bruxism was followed by 6 weeks of EMG-event-contingent treatment via an innocuous electrical pulse to the skin overlying the temporalis muscle . Treatment was discontinued during 2-week follow-up monitoring . Each night before sleep , subjects recorded their average daily pain . RESULTS Mixed-model analysis of variance showed a reliable reduction of EMG events during contingent stimulation treatment periods , but frequency of EMG events returned to baseline levels during follow-up ( linear term , P = .002 ; quadratic term , P = .001 ) . In contrast , nightly pain reports failed to show any systematic changes during treatment ( linear and quadratic trends , both P > .10 ) . CONCLUSION Spontaneous pain severity and nighttime oromotor activity vary independently over nights , even in M/TMD patients selected for relatively high levels of both characteristics UNLABELLED Several case-control studies have been conducted that examine the association between autonomic variables and persistent pain conditions ; however , there is a surprising dearth of published studies in this area that have focused on temporom and ibular disorders ( TMD ) . The current study presents autonomic findings from the baseline case-control study of the OPPERA ( Orofacial Pain : Prospect i ve Evaluation and Risk Assessment ) cooperative agreement . Measures of arterial blood pressure , heart rate , heart rate variability , and indirect measures of baroreflex sensitivity were assessed at rest and in response to a physical ( orthostatic ) and psychological ( Stroop ) stressors in 1,633 TMD-free controls and 185 TMD cases . In bivariate and demographically adjusted analyses , greater odds of TMD case status were associated with elevated heart rates , reduced heart rate variability , and reduced surrogate measures of baroreflex sensitivity across all experimental procedures . Principal component analysis was undertaken to identify latent constructs revealing 5 components . These findings provide evidence of associations between autonomic factors and TMD . Future prospect i ve analyses in the OPPERA cohort will determine if the presence of these autonomic factors predicts increased risk for developing new onset TMD . PERSPECTIVE This article reports autonomic findings from the OPPERA Study , a large prospect i ve cohort study design ed to discover causal determinants of TMD pain . Findings indicate statistically significant differences between TMD cases and controls across multiple autonomic constructs at rest and during both physical and psychologically challenging conditions . Future analyses will determine whether these autonomic factors increase risk for new onset TMD This study investigated effects of electromyographic ( EMG ) biofeedback ( BFB ) and transcutaneous electrical neuromuscular stimulation ( TENS ) on the EMG activity of the masticatory muscles and skin conductance level ( SCL ) of patients , suffering from myofacial pain syndrome . In the course of the investigation , EMG activity as well as the SCL was measured after a 20 min BFB or , respectively , after a myomonitor session in 20 patients and pre- and post-treatment values were compared . Results showed tendencies of decreased mean-EMG levels for both groups after the treatment sessions , with higher EMG values for the myomonitor group . There was no indication of a significant decrease in mean EMG levels over the sessions . Furthermore , an increase of the SCL during the period of treatment was observed for both groups in session I and II , while session III produced nearly stable values . No existing correlations for changes in SCL and EMG-activity could be established Bruxism contributes to the development of temporom and ibular disorders as well as causes dental problems . Although it is an important issue in clinical dentistry , no treatment approaches have been proven effective . This study aim ed to use electromyogram ( EMG ) biofeedback ( BF ) training to improve awake bruxism ( AB ) and examine its effect on sleep bruxism ( SB ) . Twelve male participants ( mean age , 26·8 ± 2·5 years ) with subjective symptoms of AB or a diagnosis of SB were r and omly divided into BF ( n = 7 ) and control ( CO , n = 5 ) groups to undergo 5-h daytime and night-time EMG measurements for three consecutive weeks . EMG electrodes were placed over the temporalis muscle on the habitual masticatory side . Those in the BF group underwent BF training to remind them of the occurrence of undesirable clenching activity when excessive EMG activity of certain burst duration was generated in week 2 . Then , EMGs were recorded at week 3 as the post-BF test . Those in the CO group underwent EMG measurement without any EM
Output:
| Most of the selected studies showed a significant correlation between biofeedback usage and reduction of masticatory muscle activity .
By analyzing qualified studies , it can be concluded that biofeedback can be an effective tool in masticatory muscle activity management |
MS213919 | ***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 have genotyped 14,436 nonsynonymous SNPs ( nsSNPs ) and 897 major histocompatibility complex ( MHC ) tag SNPs from 1,000 independent cases of ankylosing spondylitis ( AS ) , autoimmune thyroid disease ( AITD ) , multiple sclerosis ( MS ) and breast cancer ( BC ) . Comparing these data against a common control data set derived from 1,500 r and omly selected healthy British individuals , we report initial association and independent replication in a North American sample of two new loci related to ankylosing spondylitis , ARTS1 and IL23R , and confirmation of the previously reported association of AITD with TSHR and FCRL3 . These findings , enabled in part by increased statistical power result ing from the expansion of the control reference group to include individuals from the other disease groups , highlight notable new possibilities for autoimmune regulation and suggest that IL23R may be a common susceptibility factor for the major ' seronegative ' diseases OBJECTIVE To evaluate the efficacy and tolerability of anti-tumour necrosis factor alpha ( TNFalpha ) monoclonal antibody ( infliximab ) in the treatment of spondyloarthropathy ( SpA ) associated with active and inactive Crohn 's disease ( CD ) . METHODS Twenty four patients with SpA associated with active or inactive CD ( 16 active , 8 quiescent ) were treated with anti-TNFalpha monoclonal antibody ( infliximab ) with repeated infusions for a period of 12 - 18 months . The treatment aim ed at ameliorating the general musculoskeletal and spinal pain , controlling peripheral arthritis and enthesitis , decreasing the BASDAI score , modifying acute phase reactants , and reducing CD activity . RESULTS Infliximab improved both gastrointestinal ( p<0.01 ) and overall articular symptoms ( BASDAI , p<0.01 ; general musculoskeletal and spinal pain , p<0.01 ; peripheral arthritis , p<0.01 ) in patients with active CD . Additionally , infliximab effectively controlled not only axial involvement and peripheral arthritis but also enthesitis ( p<0.01 ) and prevented inflammatory bowel disease reactivation in patients with inactive CD and low inflammatory markers . Amelioration of gut and musculoskeletal involvement persisted for up to 12 months . CONCLUSION Infliximab may act on the inflammation of entheses and of periarticular structures , which usually does not cause a change in the haematological markers that are the main indicators of pain and joint ankylosis in SpA. Infliximab induces and maintains remission of CD while at the same time treating active and severe SpA , suggesting that it should be the preferred drug for the treatment of active and severe SpA associated with active or quiescent CD Background The adaptive immune response in rheumatoid arthritis ( RA ) is influenced by an interaction between host genetics and environment , particularly the host microbiome . Association of the gut microbiota with various diseases has been reported , though the specific components of the microbiota that affect the host response leading to disease remain unknown . However , there is limited information on the role of gut microbiota in RA . In this study we aim ed to define a microbial and metabolite profile that could predict disease status . In addition , we aim ed to generate a humanized model of arthritis to confirm the RA-associated microbe . Methods To identify an RA biomarker profile , the 16S ribosomal DNA of fecal sample s from RA patients , first-degree relatives ( to rule out environment/ background as confounding factors ) , and r and om healthy non-RA controls were sequenced . Analysis of metabolites and their association with specific taxa was performed to investigate a potential mechanistic link . The role of an RA-associated microbe was confirmed using a human epithelial cell line and a humanized mouse model of arthritis . Results Patients with RA exhibited decreased gut microbial diversity compared with controls , which correlated with disease duration and autoantibody levels . A taxon-level analysis suggested an expansion of rare taxa , Actinobacteria , with a decrease in abundant taxa in patients with RA compared with controls . Prediction models based on the r and om forests algorithm suggested that three genera , Collinsella , Eggerthella , and Faecalibacterium , segregated with RA . The abundance of Collinsella correlated strongly with high levels of alpha-aminoadipic acid and asparagine as well as production of the proinflammatory cytokine IL-17A . A role for Collinsella in altering gut permeability and disease severity was confirmed in experimental arthritis . Conclusions These observations suggest dysbiosis in RA patients result ing from the abundance of certain rare bacterial lineages . A correlation between the intestinal microbiota and metabolic signatures could determine a predictive profile for disease causation and progression Background Patients with ankylosing spondylitis ( AS ) are at increased risk of developing inflammatory bowel disease ( IBD ) . We aim ed to determine the variation in fecal calprotectin in AS over 5 years in relation to disease activity and medication and also to study the incidence of and predictors for development of IBD . Methods Fecal calprotectin was assessed at baseline ( n = 204 ) and at 5-year follow-up ( n = 164 ) . The patients answered question naires and underwent clinical evaluations . At baseline and at 5-year follow-up , ileocolonoscopy was performed in patients with fecal calprotectin ≥500 mg/kg and ≥200 mg/kg , respectively . The medical records were checked for diagnoses of IBD during the follow-up period . Results Fecal calprotectin > 50 mg/kg was found in two-thirds of the patients at both study visits . In 80 % of the patients , fecal calprotectin changed by < 200 mg/kg between the two measuring points . Baseline fecal calprotectin was positively correlated with Ankylosing Spondylitis Disease Activity Score based on C-reactive protein , Bath Ankylosing Spondylitis Disease Activity Index , Bath Ankylosing Spondylitis Functional Index , C-reactive protein , erythrocyte sedimentation rate , and fecal calprotectin at 5-year follow-up . The use of nonsteroidal anti-inflammatory drugs ( NSAIDs ) was associated with higher fecal calprotectin , and 3-week cessation of NSAIDs result ed in a drop of a median 116 mg/kg in fecal calprotectin . The use of tumor necrosis factor ( TNF ) blockers was associated with lower fecal calprotectin at both visits , but the users of TNF receptor fusion proteins had significantly higher fecal calprotectin than users of anti-TNF antibodies at 5-year follow-up . The 5-year incidence of Crohn ’s disease ( CD ) was 1.5 % and was predicted by high fecal calprotectin . Conclusions Fecal calprotectin was elevated in a majority of the patients and was associated with disease activity and medication at both visits . CD developed in 1.5 % of the patients with AS , and a high fecal calprotectin was the main predictor thereof . The results support a link between inflammation in the gut and the musculoskeletal system in AS . We propose that fecal calprotectin may be a potential biomarker to identify patients with AS at risk of developing IBD.Trial registration Clinical Trials.gov identifier : NCT00858819 . Registered 9 March 2009 . Last up date d 28 May 2015 A semi-quantitative bacteriological method was used to study faecal flora in 42 patients with Crohn 's disease , 37 with ulcerative colitis and 21 healthy controls . Faecal homogenates were plated on primary isolation plates by a technique that allowed the growth of various microbial isolates to be assessed on a visual 1(+)-5 + score . This method was first calibrated against a st and ard quantitative bacteriological technique , which confirmed the reliability and reproducibility of the results obtained by the simpler method . Patients with clinical ly active Crohn 's disease ( 22 ) had significantly higher total aerobe scores than patients with quiescent disease ( 20 ) ( p less than or equal to 0.006 ) or ulcerative colitis ( p less than or equal to 0.04 ) or normal controls ( p less than or equal to 0.02 ) . The scores of Escherichia coli were parallel to those of total aerobes . Lactobacillus and bifidobacteria scores were significantly reduced in patients with Crohn 's disease compared to those with ulcerative colitis and controls . The anaerobic flora in both Crohn 's disease and ulcerative colitis was indistinguishable from that of controls . Bacteroides vulgatus and B. fragilis were the predominant bacteroides in all groups . Patients with ulcerative colitis , regardless of disease activity , harboured faecal flora that did not differ from that of normal controls . The abnormal faecal flora in Crohn 's disease did not correlate with established clinical and laboratory indicators of disease activity Background : Although the role of microbes in disease pathogenesis is well established , data describing the variability of the vast microbiome in children diagnosed with ulcerative colitis ( UC ) are lacking . This study characterizes the gut microbiome in hospitalized children with severe UC and determines the relationship between microbiota and response to steroid therapy . Methods : Fecal sample s were collected from 26 healthy controls and 27 children hospitalized with severe UC as part of a prospect i ve multicenter study . DNA extraction , polymerase chain reaction ( PCR ) amplification of bacterial 16S rRNA , and microarray hybridization were performed . Results were analyzed in GeneSpring GX 11.0 comparing healthy controls with children with UC , and steroid responsive ( n = 17 ) with nonresponsive patients ( n = 10 ) . Results : Bacterial signal strength and distribution showed differences between UC and healthy controls ( adjusted P < 0.05 ) for Phylum , Class , Order , Family , Genus , and Phylospecies levels with reduction in Clostridia and an increase in Gamma‐proteobacteria . The number of microbial phylospecies was reduced in UC ( 266 ± 69 ) vs. controls ( 758 ± 3 , P < 0.001 ) , as was the Shannon Diversity Index ( 6.1 ± 0.23 vs. 6.49 ± 0.04 , respectively ; P < 0.0001 ) . Steroid nonresponders harbored fewer phylospecies than responders ( 142 ± 49 vs. 338 ± 62 , P = 0.013 ) . Conclusions : Richness , evenness , and biodiversity of the gut microbiome were remarkably reduced in children with UC compared with healthy controls . Children who did not respond to steroids harbored a microbiome that was even less rich than steroid responders . This study is the first to characterize the gut microbiome in a large cohort of pediatric patients with severe UC and describes changes in the gut microbiome as a potential prognostic feature . ( Inflamm Bowel Dis 2012 OBJECTIVE To determine whether sulfasalazine ( SSZ ) at a dosage of 2,000 mg/day is effective for the treatment of active psoriatic arthritis ( PsA ) resistant to nonsteroidal antiinflammatory drug therapy . METHODS Two hundred twenty-one patients with PsA were recruited from 15 clinics , r and omized ( double-blind ) to SSZ or placebo treatment , and followed up for 36 weeks . Treatment response was based on joint pain/ tenderness and swelling scores and physician and patient global assessment s. RESULTS Longitudinal analysis revealed a trend favoring SSZ treatment ( P = 0.13 ) . At the end of treatment , response rates were 57.8 % for SSZ compared with 44.6 % for placebo ( P = 0.05 ) . The Westergren erythrocyte sedimentation rate declined more in the PsA patients taking SSZ than in those taking placebo ( P < 0.0001 ) . Adverse reactions were fewer than expected and were mainly due to nonspecific gastrointestinal complaints , including dyspepsia , nausea , vomiting , and diarrhea . CONCLUSION SSZ at a dosage of 2,000 mg/day is well tolerated and may be more effective than placebo in the treatment of patients with Over the past years , mucosal healing has emerged as a major therapeutic goal in clinical trials in inflammatory bowel diseases . Accumulating evidence indicates that mucosal healing may change the natural course of the disease by decreasing the need for surgery and reducing hospitalization rates in both ulcerative colitis and Crohn 's disease . Mucosal healing may also prevent the development of long-term disease complications , such as bowel damage in Crohn 's disease and colorectal cancer in ulcerative colitis . Histologic healing may be the ultimate therapeutic goal in ulcerative colitis , whereas its impact on the course of Crohn 's disease is unknown . Complete mucosal healing may be required before considering drug withdrawal . Targeting early Crohn 's disease is more effective than approaches aim ed at healing mucosa in longst and ing disease . Several questions remain to be answered : should mucosal healing be systematic ally used in clinical practice ? Should we optimize therapies to achieve mucosal healing ? What is the degree of intestinal healing that is required to change the disease course ? Large prospect i ve studies addressing these issues are needed
Output:
| Overall , this systematic review indicates that an increase in Bifidobacterium , Staphylococcus , Enterococcus , Lactobacillus , Pseudomonas , Klebsiella and Proteus genera , as well as a decrease in Faecalibacterium , Roseburia genera and species belonging to Verrucomicrobia and Fusobacteria phyla are common features in IBD and CRD patients , whereas dozens of bacterial species are specific features of CRD and IBD . |
MS213920 | ***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 document , on the diagnosis and treatment of patients with hepatocellular carcinoma ( HCC ) , was commissioned by the British Society of Gastroenterology as part of a wider initiative to develop guidelines for clinicians in several areas of clinical practice . Cancer care has been the subject of increased scrutiny , with the development of care guidelines forming a major part of the strategy to reduce cancer related mortality in the UK . There is a strong suggestion that HCC is a disease which will be seen more frequently over the next few years , mainly as a result of the hepatitis C virus ( HCV ) epidemic . Previously , HCC has been a relatively rare tumour in the UK and much of the data pertaining to its diagnosis and therapy are derived from studies outside of the UK . Because of the lack of screening programmes and the fact that a significant proportion of HCC presents as symptomatic disease in individuals not known to have liver disease , most non-surgical therapies have been used in patients with advanced disease . There are a significant number of variables known to influence prognosis , with stage of underlying liver disease and tumour size at presentation being the most important . Controlling for these variables is difficult and these factors have contributed to a dearth of r and omised controlled trials of treatment for this tumour . There is however a substantial amount of evidence available which can form the basis of a framework for diagnosis and management . Guidelines are not rigid protocol s and they should not be construed as interfering with local clinical judgement . Hence they do not represent a directive of proscribed routes but a basis on which clinicians can consider the options available more clearly . These guidelines cover two areas of clinical practice relating to HCC : firstly , its diagnosis , including surveillance of high risk individuals ; and AIMS We assessed the role of contrast-enhanced ultrasound ( CEUS ) in the differential diagnosis between benign and malignant portal vein thrombosis ( PVT ) in patients who had liver tumors . METHODS Seventeen consecutive patients who had cirrhosis , liver tumors , and PVT were prospect ively studied with CEUS . CEUS was performed at low mechanical index after intravenous administration of a second-generation contrast agent ( SonoVue , Bracco , Milan , Italy ) . Presence or absence of thrombus enhancement on CEUS were considered diagnostic for malignant or benign PVT . Five patients also underwent percutaneous portal vein fine-needle biopsy under US guidance . All patients were followed-up . Shrinkage of the thrombus and /or recanalization of the vessels on CDUS during follow-up were considered definitive evidence of the benign nature of the thrombosis , whereas the enlargement of the thrombus , disruption of the vessel wall , and parenchymal infiltration over follow-up were considered consistent with malignancy . RESULTS Follow-up showed signs of malignant thrombosis in 14 of 17 patients . CEUS showed early arterial enhancement of the PVT in 14 patients of 14 malignant PVT , 1 patient of 3 benign PVT and the absence of thrombus enhancement in 2 patients of 3 benign PVT . FNB confirmed the results for malignant PVT in four of five patients , for benign granulomatous inflammation PVT in one of five patients in which CEUS showed early arterial enhancement of the PVT . The sensitivity , specificity and accuracy is 100 % , 66.7 % and 93.3 % at diagnosis of malignant PVT using CEUS . In one patient with intrahepatic bile duct stone , CEUS were positive for malignant PVT , whereas FNB was negative ( benign granulomatous inflammation PVT ) ; follow-up examination confirmed benign PVT . CONCLUSION CEUS seems to be the pretty sensitive and specific test for diagnosing malignant portal vein thrombosis in patients with cirrhosis and tumors Background We assessed the role of contrast-enhanced ultrasound ( CEUS ) in the differential diagnosis between benign and malignant portal vein thrombosis in patients who had cirrhosis with hepatocellular carcinoma ( HCC ) . Methods Fifty-four consecutive patients who had cirrhosis , biopsy-proved HCC , and thrombosis of the main portal vein and /or left/right portal vein on US were prospect ively studied with color Doppler US ( CDUS ) and CEUS . CEUS was performed at low mechanical index after intravenous administration of a second-generation contrast agent ( SonoVue , Bracco , Milan , Italy ) . Presence or absence of CDUS signals or thrombus enhancement on CEUS were considered diagnostic for malignant or benign portal vein thrombosis . Twenty-eight patients also underwent percutaneous portal vein fine-needle biopsy ( FNB ) under US guidance . All patients were followed-up bimonthly by CDUS . Shrinkage of the thrombus and /or recanalization of the vessels on CDUS during follow-up were considered definitive evidence of the benign nature of the thrombosis , whereas enlargement of the thrombus , disruption of the vessel wall , and parenchymal infiltration over follow-up were considered consistent with malignancy . CDUS , CEUS , and FNB results were compared with those at follow-up . Results Follow-up ( 4 to 21 months ) showed signs of malignant thrombosis in 34 of 54 patients . FNB produced a true-positive result for malignancy in 19 of 25 patients , a false-negative result in six of 25 patients , and a true-negative result in three of three patients . CDUS was positive in seven of 54 patients . CEUS showed enhancement of the thrombus in 30 of 54 patients . No false-positive result was observed at CDUS , CEUS , and FNB . Sensitivities of CDUS , CEUS , and FNB in detecting malignant thrombi were 20 % , 88 % , and 76 % respectively . Three patients showed negative CDUS and CEUS and positive FNB results ; follow-up confirmed malignant thrombosis in these patients . One patient showed negative CDUS , CEUS , and FNB findings . Howewer , follow-up of the thrombus showed US signs of malignancy . Another FNB confirmed HCC infiltration of the portal vein . Conclusion CEUS seems to be the most sensitive and specific test for diagnosing malignant portal vein thrombosis in patients with cirrhosis OBJECTIVES To select an appropriate treatment regimen , it is essential to accurately characterize the nature of a thrombus . This study prospect ively assessed the ability of contrast-enhanced sonography to differentiate between benign and malignant portal vein thrombosis in a population of high-risk patients . METHODS Fifty-five patients ( 43 men and 12 women ; mean age , 66 years ; range , 55 - 83 years ) with thrombi of the portal venous system were examined by power Doppler sonography and contrast-enhanced sonography with the intravenous contrast agent SH U 508A ( Levovist ; Schering AG , Berlin , Germany ) . Of the thrombi , 40 were characterized as malignant and 15 as benign . Pulsatile flow in the thrombus on power Doppler sonography and positive enhancement of the thrombus on contrast-enhanced sonography were judged as indications of a malignant thrombus . The sensitivity and specificity of both methods in differentiating the nature of the thrombus were evaluated . RESULTS The detection of pulsatile flow in a portal vein thrombus as the criterion for diagnosing malignant portal vein thrombus yielded overall sensitivity of 82.5 % and specificity of 100 % , whereas positive enhancement of the portal vein thrombus itself as a criterion for diagnosing malignancy yielded overall sensitivity and specificity of 100 % for each . CONCLUSIONS Contrast-enhanced sonography can be helpful in discriminating between benign and malignant portal vein thrombi OBJECTIVE The objective of our study was to determine if the detection by Doppler sonography of blood flow in portal vein thrombi occurring in patients with cirrhosis could be used to distinguish benign from malignant portal vein thrombi . SUBJECTS AND METHODS Color and duplex Doppler sonographic examinations were performed in 47 patients with proven cirrhosis and portal vein thrombi . The examinations were directed at the detection of continuous or pulsatile flow within the portal vein thrombi . The nature of the portal vein thrombi was proven histologically in 27 patients and by CT findings and clinical history in 20 patients . The frequency , type , and direction of portal vein thrombus flow was evaluated to determine if there was any correlation with the benign or malignant nature of the portal vein thrombi . RESULTS Of the 47 patients , 26 had malignant portal vein thrombi and 21 had benign portal vein thrombi . Blood flow was detected in 22 of the malignant and in 15 of the benign portal vein thrombi . The blood flow was pulsatile in 16 malignant and three benign portal vein thrombi and continuous in six malignant and 12 benign portal vein thrombi . The direction of the pulsatile flow in the malignant portal vein thrombi was predominantly ( 13/16 ) hepatofugal . All continuous flow in both benign and malignant portal vein thrombi was hepatopetal . The detection of pulsatile flow in portal vein thrombi yielded a 62 % sensitivity and 95 % specificity for the diagnosis of malignant portal vein thrombus . CONCLUSION The detection by Doppler sonography of pulsatile flow in portal vein thrombi occurring in patients with cirrhosis is a moderately sensitive but highly specific sign for the diagnosis of malignant portal vein thrombus . However , continuous flow can be detected in benign and malignant portal vein thrombus and is thus not useful in differentiating between the two BACKGROUND AND OBJECTIVE Publication bias and other sample size effects are issues for meta-analyses of test accuracy , as for r and omized trials . We investigate limitations of st and ard funnel plots and tests when applied to meta-analyses of test accuracy and look for improved methods . METHODS Type I and type II error rates for existing and alternative tests of sample size effects were estimated and compared in simulated meta-analyses of test accuracy . RESULTS Type I error rates for the Begg , Egger , and Macaskill tests are inflated for typical diagnostic odds ratios ( DOR ) , when disease prevalence differs from 50 % and when thresholds favor sensitivity over specificity or vice versa . Regression and correlation tests based on functions of effective sample size are valid , if occasionally conservative , tests for sample size effects . Empirical evidence suggests that they have adequate power to be useful tests . When DORs are heterogeneous , however , all tests of funnel plot asymmetry have low power . CONCLUSION Existing tests that use st and ard errors of odds ratios are likely to be seriously misleading if applied to meta-analyses of test accuracy . The effective sample size funnel plot and associated regression test of asymmetry should be used to detect publication bias and other sample size related effects Malignant portal vein thrombosis is a contraindication for liver transplantation . Patients with cirrhosis and early hepatocellular carcinoma ( HCC ) may have either malignant or benign ( fibrin clot ) portal vein thrombosis . The aim of this study was to assess prospect ively whether well-defined diagnostic criteria would enable the nature of portal vein thrombosis to be established in patients with HCC under consideration for liver transplantation . Benign portal vein thrombosis was diagnosed by the application of the following criteria : lack of vascularization of the thrombus on contrast-enhanced ultrasound and on computed tomography or magnetic resonance imaging , absence of mass-forming features of the thrombus , absence of disruption of the walls of veins , and , if uncertainty persisted , biopsy of the thrombus for histological examination . Patients who did not fulfill the criteria for benign thrombosis were not placed on the transplantation list . In this study , all patients evaluated at our center during 2001 - 2007 with a diagnosis of HCC in whom portal vein thrombosis was concurrently or subsequently diagnosed were discussed by a multidisciplinary group to determine their suitability for liver transplantation . The outcomes for 33 patients who met the entry criteria of the study were as follows : in 14 patients who were placed on the transplantation list and underwent liver transplantation , no malignant thrombosis was detected when liver explants were examined histologically ; 5 patients who were placed on the transplantation list either remained on the list or died from causes unrelated to HCC ; in 9 patients , liver transplantation was contraindicated on account of a strong suspicion , or confirmation , of the presence of malignant portal vein thrombosis ; and 5 patients who were initially placed on the transplantation list were subsequently removed from it on account of progression of HCC in the absence of evidence of neoplastic involvement of thrombosis . In conclusion , for a patient with HCC and portal vein thrombosis , appropriate investigations can establish whether the thrombosis is benign ; patients with HCC and benign portal vein thrombosis are c and i date s for liver transplantation BACKGROUND AND AIM We aim ed to vali date the non-invasive criteria for the characterization of portal vein thrombosis ( PVT ) in patients with cirrhosis and hepatocellular carcinoma ( HCC ) . In a prospect i ve study , we examined the impact of arterial hypervascularity , as established by the European Association for the Study of the Liver and the American Association for the Study of Liver Diseases recommendations for the non-invasive diagnosis of HCC , as a criterion for characterizing macroscopic PVT ( EASL/AASLD extension criteria ) . METHODS A total of 96 cases of PVT detected using ultrasonography in patients
Output:
| CEUS is highly efficient in differentiating TIV from PVT and is an alternative or a substitute for CT and /or MRI .
PROSPERO registration number : CRD42019138847 • Characterization of portal vein thrombosis ( PVT ) vs tumor-in-vein ( TIV ) is critical for HCC staging . •
CEUS has an excellent safety profile , provides a real-time analysis without any loss in accuracy compared with CT and MRI . •
This meta- analysis demonstrates that contrast-enhanced ultrasound ( CEUS ) is a suitable method for the detection of PVT and distinction with TIV |
MS213921 | ***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 To investigate the benefit of chemotherapy in patients with symptomatic hormone-resistant prostate cancer using relevant end points of palliation in a r and omized controlled trial . PATIENTS AND METHODS We r and omized 161 hormone-refractory patients with pain to receive mitoxantrone plus prednisone or prednisone alone ( 10 mg daily ) . Nonresponding patients on prednisone could receive mitoxantrone subsequently . The primary end point was a palliative response defined as a 2-point decrease in pain as assessed by a 6-point pain scale completed by patients ( or complete loss of pain if initially 1 + ) without an increase in analgesic medication and maintained for two consecutive evaluations at least 3 weeks apart . Secondary end points were a decrease of > or = 50 % in use of analgesic medication without an increase in pain , duration of response , and survival . Health-related quality of life was evaluated with a series of linear analog self- assessment scales ( LASA and the Prostate Cancer-Specific Quality -of-Life Instrument [ PROSQOLI ] ) , the core question naire of the European Organization for Research and Treatment of Cancer ( EORTC ) , and a disease-specific module . RESULTS Palliative response was observed in 23 of 80 patients ( 29 % ; 95 % confidence interval , 19 % to 40 % ) who received mitoxantrone plus prednisone , and in 10 of 81 patients ( 12 % ; 95 % confidence interval , 6 % to 22 % ) who received prednisone alone ( P = .01 ) . An additional seven patients in each group reduced analgesic medication > or = 50 % without an increase in pain . The duration of palliation was longer in patients who received chemotherapy ( median , 43 and 18 weeks ; P < .0001 , log-rank ) . Eleven of 50 patients r and omized to prednisone treatment responded after addition of mitoxantrone . There was no difference in overall survival . Treatment was well tolerated , except for five episodes of possible cardiac toxicity in 130 patients who received mitoxantrone . Most responding patients had an improvement in quality -of-life scales and a decrease in serum prostate-specific antigen ( PSA ) level . CONCLUSION Chemotherapy with mitoxantrone and prednisone provides palliation for some patients with symptomatic hormone-resistant prostate cancer Sipuleucel‐T is an investigational active cellular immunotherapy product design ed to stimulate an immune response against prostate cancer . The safety and efficacy of sipuleucel‐T was evaluated in 2 identically design ed , r and omized , double‐blind , placebo‐controlled trials ( D9901 and D9902A ) conducted in men with advanced prostate cancer BACKGROUND Mitoxantrone-based chemotherapy palliates pain without extending survival in men with progressive and rogen-independent prostate cancer . We compared docetaxel plus estramustine with mitoxantrone plus prednisone in men with metastatic , hormone-independent prostate cancer . METHODS We r and omly assigned 770 men to one of two treatments , each given in 21-day cycles : 280 mg of estramustine three times daily on days 1 through 5 , 60 mg of docetaxel per square meter of body-surface area on day 2 , and 60 mg of dexamethasone in three divided doses before docetaxel , or 12 mg of mitoxantrone per square meter on day 1 plus 5 mg of prednisone twice daily . The primary end point was overall survival ; secondary end points were progression-free survival , objective response rates , and post-treatment declines of at least 50 percent in serum prostate-specific antigen ( PSA ) levels . RESULTS Of 674 eligible patients , 338 were assigned to receive docetaxel and estramustine and 336 to receive mitoxantrone and prednisone . In an intention-to-treat analysis , the median overall survival was longer in the group given docetaxel and estramustine than in the group given mitoxantrone and prednisone ( 17.5 months vs. 15.6 months , P=0.02 by the log-rank test ) , and the corresponding hazard ratio for death was 0.80 ( 95 percent confidence interval , 0.67 to 0.97 ) . The median time to progression was 6.3 months in the group given docetaxel and estramustine and 3.2 months in the group given mitoxantrone and prednisone ( P<0.001 by the log-rank test ) . PSA declines of at least 50 percent occurred in 50 percent and 27 percent of patients , respectively ( P<0.001 ) , and objective tumor responses were observed in 17 percent and 11 percent of patients with bidimensionally measurable disease , respectively ( P=0.30 ) . Grade 3 or 4 neutropenic fevers ( P=0.01 ) , nausea and vomiting ( P<0.001 ) , and cardiovascular events ( P=0.001 ) were more common among patients receiving docetaxel and estramustine than among those receiving mitoxantrone and prednisone . Pain relief was similar in both groups . CONCLUSIONS The improvement in median survival of nearly two months with docetaxel and estramustine , as compared with mitoxantrone and prednisone , provides support for this approach in men with metastatic , and rogen-independent prostate cancer BACKGROUND The alpha-emitter radium-223 ( (223)Ra ) is a bone-seeking radionuclide studied as a new treatment for patients with bone metastases from hormone-refractory prostate cancer . We aim ed to study mature outcomes from a r and omised , multicentre , phase II study of (223)Ra . METHODS Patients with hormone-refractory prostate cancer and bone pain needing external-beam radiotherapy were assigned to four intravenous injections of (223)Ra ( 50 kBq/kg , 33 patients ) or placebo ( 31 patients ) , given every 4 weeks . Primary endpoints were change in bone-alkaline phosphatase ( ALP ) concentration and time to skeletal-related events ( SREs ) . Secondary endpoints included toxic effects , time to prostate-specific-antigen ( PSA ) progression , and overall survival . All tests were done at a 5 % significance level , based on intention to treat . FINDINGS Median relative change in bone-ALP during treatment was -65.6 % ( 95 % CI -69.5 to -57.7 ) and 9.3 % ( 3.8 - 60.9 ) in the (223)Ra group and placebo groups , respectively ( p<0.0001 , Wilcoxon ranked-sums test ) . Hazard ratio for time to first SRE , adjusted for baseline covariates , was 1.75 ( 0.96 - 3.19 , p=0.065 , Cox regression ) . Haematological toxic effects did not differ significantly between two groups . No patient discontinued (223)Ra because of treatment toxicity . Median time to PSA progression was 26 weeks ( 16 - 39 ) versus 8 weeks ( 4 - 12 ; p=0.048 ) for (223)Ra versus placebo , respectively . Median overall survival was 65.3 weeks ( 48.7-infinity ) for (223)Ra and 46.4 weeks ( 32.1 - 77.4 ) for placebo ( p=0.066 , log rank ) . The hazard ratio for overall survival , adjusted for baseline covariates was 2.12 ( 1.13 - 3.98 , p=0.020 , Cox regression ) . INTERPRETATION (223)Ra was well tolerated with minimum myelotoxicity , and had a significant effect on bone-ALP concentrations . Larger clinical trials are warranted to study (223)Ra on the prevention of SREs and on overall survival in patients with hormone-refractory prostate cancer . Bone-targeting properties of (223)Ra could also potentially be used for treating skeletal metastasis from other primary cancers To compare combination therapy with bicalutamide 80 mg and a luteinizing hormone-releasing hormone agonist ( LHRH-A ) versus LHRH-A alone in Japanese men with untreated advanced prostate cancer . A total of 205 patients with stage C/D prostate cancer were r and omized to either LHRH-A+once-daily oral bicalutamide 80 mg or placebo . Primary study variables have been reported previously . Secondary variables included : time to achieve prostate-specific antigen⩽4 ng/ml , time-to-treatment failure ( TTTF ) , time-to-disease progression ( TTP ) , overall survival ( OS ) , adverse events and adverse drug reactions . Following combination therapy with bicalutamide 80 mg , there were significant ( P<0.001 ) advantages over LHRH-A alone in terms of TTTF and TTP , but the difference in the interim OS was not statistically significant . First-line combination therapy with bicalutamide 80 mg in Japanese patients with advanced prostate cancer offers significant benefits over LHRH-A alone , with respect to TTTF and TTP . Follow-up for OS continues BACKGROUND Sipuleucel-T , an autologous active cellular immunotherapy , has shown evidence of efficacy in reducing the risk of death among men with metastatic castration-resistant prostate cancer . METHODS In this double-blind , placebo-controlled , multicenter phase 3 trial , we r and omly assigned 512 patients in a 2:1 ratio to receive either sipuleucel-T ( 341 patients ) or placebo ( 171 patients ) administered intravenously every 2 weeks , for a total of three infusions . The primary end point was overall survival , analyzed by means of a stratified Cox regression model adjusted for baseline levels of serum prostate-specific antigen ( PSA ) and lactate dehydrogenase . RESULTS In the sipuleucel-T group , there was a relative reduction of 22 % in the risk of death as compared with the placebo group ( hazard ratio , 0.78 ; 95 % confidence interval [ CI ] , 0.61 to 0.98 ; P=0.03 ) . This reduction represented a 4.1-month improvement in median survival ( 25.8 months in the sipuleucel-T group vs. 21.7 months in the placebo group ) . The 36-month survival probability was 31.7 % in the sipuleucel-T group versus 23.0 % in the placebo group . The treatment effect was also observed with the use of an unadjusted Cox model and a log-rank test ( hazard ratio , 0.77 ; 95 % CI , 0.61 to 0.97 ; P=0.02 ) and after adjustment for use of docetaxel after the study therapy ( hazard ratio , 0.78 ; 95 % CI , 0.62 to 0.98 ; P=0.03 ) . The time to objective disease progression was similar in the two study groups . Immune responses to the immunizing antigen were observed in patients who received sipuleucel-T. Adverse events that were more frequently reported in the sipuleucel-T group than in the placebo group included chills , fever , and headache . CONCLUSIONS The use of sipuleucel-T prolonged overall survival among men with metastatic castration-resistant prostate cancer . No effect on the time to disease progression was observed . ( Funded by Dendreon ; Clinical Trials.gov number , NCT00065442 . BACKGROUND Abiraterone and docetaxel are both approved treatments for men with metastatic castration-resistant prostate cancer ( mCRPC ) . Abiraterone pre-docetaxel is currently undergoing evaluation in a phase III study . In vitro studies indicate that taxanes may act by disrupting and rogen receptor signalling . We hypothesised that prior abiraterone exposure would adversely impact docetaxel efficacy . PATIENTS AND METHODS We retrospectively evaluated activity of docetaxel in mCRPC patients previously treated with abiraterone , using Prostate Cancer Working Group and radiological criteria . RESULTS Of the 54 patients treated with abiraterone , 35 subsequently received docetaxel . Docetaxel result ed in a prostate-specific antigen ( PSA ) decline of ≥50 % in nine patients [ 26 % , 95 % confidence interval ( CI ) 13 % to 43 % ] , with a median time to PSA progression of 4.6 months ( 95 % CI 4.2 % to 5.9 % ) . PSA declines ≥30 % were achieved by 13 patients ( 37 % , 95 % CI 22 % to 55 % ) . The median overall survival was 12.5 months ( 95 % CI 10.6 - 19.4 ) . All patients who failed to achieve a PSA fall on abiraterone and were deemed abiraterone-refractory were also docetaxel-refractory ( N = 8) . In the 24 patients with radiologically evaluable disease , partial responses were reported in four patients ( 11 % ) , none of whom were abiraterone-refractory . CONCLUSION The activity of docetaxel post-ab
Output:
| The best evidence was found for abiraterone and enzalutamide for effective prolongation of OS and PFS to treat chemotherapy-naive patients with mCRPC . |
MS213922 | ***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 adrenocorticotropic hormone ( ACTH ) and cortisol responses to apomorphine ( APO ) , a direct acting dopamine ( DA ) agonist , have been reported to be significantly blunted in neuroleptic-free patients with schizophrenia ( SCH ) . This study primarily examined the cortisol , but also the prolactin ( PRL ) and growth hormone ( GH ) , response to APO in patients with SCH compared to normal controls , as well as the relationship between endocrine measures and response to antipsychotic drug treatment . APO , 0.01 mg/kg , or placebo was administered to 51–98 patients with SCH and 15–25 normal controls . Psychopathology was assessed at the baseline and six weeks after drug treatment . The plasma cortisol response to APO was markedly blunted in patients with SCH compared to normal controls . Patients who responded to six weeks of treatment with antipsychotic drugs had a higher cortisol response to APO compared to non-responders . The plasma GH , but not PRL , response to APO was blunted in male patients with SCH . Neither plasma GH nor PRL responses to APO were related to treatment response at six weeks . These results provide further evidence of dopaminergic dysfunction in SCH . Furthermore , the APO-stimulated cortisol response may be predictive of subsequent clinical response to antipsychotic drug treatment Some investigators have speculated that structural brain alterations observed in some psychiatric patients might be related to increased limbic-hypothalamic-pituitary-adrenal axis ( LHPA ) activity . To explore this hypothesis , we prospect ively studied 166 research volunteers ( 19 patients with research diagnostic criteria ( RDC ) major depression , 9 patients with RDC bipolar depression , 45 patients with RDC schizophrenia , and 94 RDC normal controls ) , examining the relationship between magnetic resonance image-determined ventricular-to-brain ratio ( VBR ) and indices of LHPA axis function ( cerebrospinal fluid ( CSF ) corticotropin-releasing factor ( CRF ) , CSF adrenocorticotropic hormone ( ACTH ) , and 24-hour urinary-free cortisol secretion ) . We observed no significant differences in mean VBR among the three patient groups and the normal control volunteers . Of the indices of LHPA activity , only CSF CRF concentrations distinguished the four subject groups , with CSF CRF being significantly elevated in the more severely depressed major depression patients . Indices of LHPA activity were not significantly correlated with VBR in any of the three patient groups or in the normal volunteers . These preliminary results suggest that VBR is not highly associated with alterations in LHPA activity , at least as determined cross-sectionally . Further longitudinal studies with reference to diagnostic subtypes , severity , symptom profiles , and more specific neuroanatomic regions may allow the elucidation of possible relationships between LHPA pathology and structural brain alterations This study examined the prolactin ( PRL ) , adrenocorticotropin ( ACTH ) and cortisol responses to the direct DA receptor agonist apomorphine ( APO ) and the selective 5HT-releasing agent d-fenfluramine ( d-FEN ) in 20 untreated in patients with DSM-IV schizophrenia and without a history of suicide attempt , compared to 23 hospitalized healthy controls . We hypothesized that different patterns of responsiveness of the DA and 5-HT systems might be associated with specific schizophrenic symptom clusters . A positive correlation was observed between pituitary-adrenal response to APO and d-FEN tests ( i.e. deltaACTH and deltacortisol ) in the overall population and in schizophrenic patients . Pituitary-adrenal response to APO was lower in patients than in normal controls . Moreover , lower pituitary-adrenal response to APO and d-FEN was associated with increased severity of BPRS thought disturbance score . Lower pituitary-adrenal responses to APO ( and to a lesser degree to d-FEN ) differentiated paranoid from disorganized schizophrenic patients . Neither PRL suppression to APO , nor PRL stimulation to d-FEN were altered in schizophrenic patients . Our results suggest that decreased hypothalamic DA receptor activity ( possibly secondary to increased presynaptic DA release ) together with relatively decreased 5-HT tone characterize paranoid SCH , while normal hypothalamic DA receptor activity together with relatively increased 5-HT tone characterize the disorganized SCH subtype In an attempt to define potential immunological dysfunctions in schizophrenia , we determined the production of interleukin-2 ( IL-2 ) , interleukin-4 ( IL-4 ) , interferon-γ ( IFN-γ ) , and soluble IL-2 receptor ( sIL-2R ) in a whole-blood assay after stimulation with phytohemagglutinin ( PHA ) as well as the serum concentrations of sIL-2R . Because CD4+CD45RO+T cells are the main producers of IFN-γ , we determined the percentage of these cells , as well as of pan T , CD4+T , and CD8+T cells , by flow cytometry . A whole-blood count was performed in addition . Two groups of patients were examined , paranoid-type and residual-type schizophrenics . The numbers of both monocytes and neutrophils , but not of lymphocytes , were increased significantly in the schizophrenic sample . The IFN-γ production of the schizophrenics as a whole group , and of the paranoid patients , was reduced significantly in comparison with the control group ( p≤0.05 ) . The residual patients produced less IFN-γ than the controls , but more than the paranoid patients . The latter differences did not reach statistical significance . The production of IL-4 , which physiologically antagonizes the production of IFN-γ , was not significantly higher in the patient group . No changes in the lymphocyte sub population s were observed . The production of IL-2 showed a trend toward reduction in paranoid patients , but not in residual schizophrenics . The serum sIL-2R levels were elevated slightly in schizophrenics when compared with controls . In order to rule out a possible effect of cortisol on cytokine production , 20 schizophrenic were compared with 20 age- and gendermatched controls . However , neither elevated cortisol levels were detected in the schizophrenic sample , nor significant intercorrelations between cortisol levels and cytokine production , or levels of sIL-2R , respectively . In summary , our data reinforce the possibility of immune dysfunction in schizophrenia and point to the possible relevance of disease subgroups in this respect OBJECTIVES Higher rates of dexamethasone test ( DST ) nonsuppression in schizophrenia have been attributed to depressive symptoms , suicidality and negative symptoms . No study concerning first-episode schizophrenia has yet been published . DESIGN In patients hospitalised for the first time with first-episode schizophrenia the DST has been performed before , at the end of the acute treatment and after one year . At the same time the clinical evaluation with PANSS was performed . A cortisol value > 5 microgram/dl in either of the postdexamethasone sample s indicated nonsuppression of cortisol . RESULTS A total of 56 males were included . 18 % of pts were DST nonsuppressors at medication-free baseline , 5 % and 16 % after acute treatment and after one year respectively . After 1 year 42/56 of patients fulfilled the criteria of remission . The rate of nonsuppression was 21.4 % , 5 % and 16.4 % in remitters and 7 % , 7 % and 14.3 % in nonremitters . Significant differences in the whole group were found between postdexamethasone cortisolemia at discharge on the one h and and on admission and at the one-year follow-up on the other . Significant correlations were observed between postdexamethasone cortisolemia and negative symptoms at the end of acute treatment . MAIN FINDINGS In first-episode schizophrenia the short-term treatment led to a decrease in cortisolemia and rates of nonsuppression and an increase at a one-year follow-up . CONCLUSIONS Rates of DST nonsuppression in schizophrenia including first-episode schizophrenia are influenced by the stage of illness and medication status . The impairment of feedback regulation of cortisol secretion may be related to different biopathogenetic mechanisms depending on the phase of the illness Psychosocial stress is a potent activator of the hypothalamus-pituitary-adrenal ( HPA ) axis . While the physiological mechanisms of HPA axis responses to stress as well as its short and long-term consequences have been extensively examined , less is known why someone elicits an acute neuroendocrine stress response , i.e. what are the psychological processes involved and how are they related to the acute neuroendocrine stress response . To examine this question , a question naire to assess anticipatory cognitive appraisal processes was developed and administered to 81 male healthy subjects in a st and ardized psychosocial stress situation ( Trier social stress test ) . Cortisol stress responses were assessed with repeated measurement of salivary free cortisol . Hierarchical regression analyses show that anticipatory cognitive appraisal , in contrast to general personality factors and retrospective stress appraisal is an important determinant of the cortisol stress response , explaining up to 35 % of the variance of the salivary cortisol response . The reported results emphasize the importance of psychological stress processing for the underst and ing of psychobiological stress responses . Since stress and its biological consequences have been shown to be associated with the onset and the maintenance of somatic illnesses and psychiatric disorders , psychological processes are prime targets for prevention and intervention Summary Psychotic patients underwent a dexamethasone suppression test ( DST ) , careful diagnostic assessment s at baseline and diagnostic reevaluations after 1 year . The predicted associations between baseline DST results and diagnosis were much clearer after prospect i ve observation Most prospect i ve studies of HPA axis have found that non-suppressors in the dexamethasone suppression test ( DST ) are more likely to commit suicide during the follow-up . Attempted suicide is a strong clinical predictor of suicide . The aim of this study was to assess the predictive value of DST for suicide in a group of depressed in patients with and without an index suicide attempt . Historical cohort of 382 psychiatric in patients with mood disorder admitted to the department of Psychiatry at the Karolinska University Hospital between 1980 and 2000 were su bmi tted to the DST and followed up for causes of death . During the follow-up ( mean 18 years ) , 36 suicides ( 9.4 % ) occurred , 20 of these were non-suppressors and 16 were suppressors . There was no statistically significant difference in suicide risk between the suppressors and non-suppressors for the sample as a whole . An index suicide attempt predicted suicide . In suicide attempters with mood disorder , the non-suppressor status was significantly associated with suicide indicating that HPA axis hyperactivity is a risk factor for suicide in this group . The dexamethasone suppression test may be a useful predictor within this population BACKGROUND Thyrotropin-releasing hormone ( TRH ) test and Dexamethasone Suppression Test ( DST ) are two neuroendocrine tests that have been extensively used in an attempt to predict treatment response and outcome in schizophrenia . The objectives of this study were to investigate ( 1 ) the relationship between TRH test and DST and various psychiatric symptoms and ( 2 ) the potential value of these tests in prediction of short-term outcome in schizophrenic patients . METHODS TRH test and DST were administered to 58 patients with schizophrenia . All patients were evaluated with a battery of rating scales before neuroendocrine test procedures and at regular intervals for 1 year . Patients were divided into two groups as remitted ( RP ; n = 30 ) and nonremitted patients ( NRP ; n = 28 ) . Baseline results of these two groups were compared with each other and 30 healthy controls . RESULTS Basal levels of total T3 ( T3 T ) and free T3 ( T3F ) were higher in RP group than controls . Basal prolactin ( PRL ) level was higher in RP group , but not in NRP , compared to controls . Basal growth hormone ( GH ) and thyroid-stimulating hormone ( TSH ) levels of NRP were significantly higher than those of RP . DST nonsuppression was observed at a significantly higher rate in RP than NRP and control group . Blunted TSH response rate in RP group was higher significantly compared to other two groups . CONCLUSIONS The data implicate that higher basal TSH and GH levels may be associated with a poorer treatment response , whereas higher total and free T3 levels , a blunted TSH response to TRH and nonsuppression on the DST may indicate a better response in schizophrenics Pretreatment measures of hypothalamic-pituitary-adrenocortical ( HYPAC ) function in depressed , manic , and healthy normal subjects showed that nonsuppression on the dexamethasone suppression test ( DST ) had less positive predictive value for major diagnostic category and was more frequent in normals ( 8/77 ) than recently reported , although it was yet more frequent in depressed patients ( 35/111 ) . Nonsuppression was common in manics ( 8/16 ) , was similar in unipolar and bipolar depressed patients ( 35 % and 27 % , respectively ) , and did not segregate with melancholic , endogenous , or psychotic depression subtypes . Patterns of post-DST plasma cortisol concentration other than simple escape or nonescape from suppression were
Output:
| In summary , the evidence suggests people with schizophrenia can experience both hyper- and hypo-function of the HPA axis .
It is likely that this contributes to the pattern of poor physical health and premature mortality suffered by people with schizophrenia , in particular the high rates of cardiovascular and metabolic disturbance |
MS213923 | ***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: We studied the influence of mivacurium on the recovery profile following outpatient laparoscopic tubal ligation in 60 healthy , nonpregnant women . After administration of midazolam 2 mg intravenously ( IV ) , anesthesia was induced with fentanyl , 2 micrograms/kg , and thiopental , 4 mg/kg , IV . When the patient became unresponsive ( loss of eyelid reflex ) , either succinylcholine 1 mg/kg , IV ( Group I ) , or mivacurium 0.2 mg/kg , IV ( Groups II and III ) , was administered to facilitate tracheal intubation . Anesthesia was maintained with isoflurane ( 0.5%-2 % inspired concentration ) in combination with 67 % N2O in oxygen . Muscle relaxation was maintained in all three groups with intermittent bolus doses of mivacurium , 2 - 4 mg , IV . In Group III , residual neuromuscular block was reversed with a combination of neostigmine , 2.5 mg , and glycopyrrolate , 0.5 mg , IV , at the end of the operation . In the postanesthesia care unit ( PACU ) , patients in Group III had a significantly increased incidence of postoperative nausea and vomiting compared to Group II . The use of succinylcholine ( versus mivacurium ) was also associated with more frequent postoperative nausea and vomiting . However , these emetic sequelae did not delay postoperative recovery times . In addition , a comparable number of patients in each treatment group required analgesic medication for postoperative pain . Although patients who received succinylcholine complained of significantly more neck pain during the 24-h period after discharge , nausea , vomiting , and shoulder pain were similar in all three groups during this period . We conclude that neostigmine and glycopyrrolate may contribute to the development of postoperative emesis when used for reversal of residual neuromuscular block . ( ABSTRACT TRUNCATED AT 250 WORDS Intrathecal ( IT ) neostigmine produces analgesia in animals and humans and enhances systemic opioid analgesia . To examine the safety of IT neostigmine for eventual use in obstetrics , we studied 24 healthy , term pregnant patients scheduled to receive elective cesarean section using a combined spinal-epidural anesthetic . Using an open-label , dose-ranging design , patients received either IT placebo or neostigmine 10 , 30 , or 100 microg in a 1-mL solution of 5 % glucose in normal saline followed in 15 min by 2 % epidural lidocaine for cesarean section . Neostigmine did not affect fetal heart rate tracings or Apgar scores . The women received patient-controlled analgesia intravenous morphine postoperatively . Compared with the glucose control , neostigmine produced a dose-independent reduction in postoperative morphine use . Cumulative average 24-h morphine use was 82 + /- 7 mg for women receiving IT placebo and 50 + /- 8 mg for women receiving IT neostigmine ( P < 0.003 ) . Hourly morphine use was significantly reduced in the neostigmine groups for 10 h postoperatively . These data indicate that IT neostigmine can produce 10 h of post-cesarean section analgesia without adverse fetal effects and support cautious further prospect i ve study Thirty-eight patients undergoing elective hip or knee surgery were r and omly allocated to two groups . Neuromuscular blockade in group A was antagonized with neostigmine 2.5 mg and atropine 1.2 mg , while group B received no drugs to facilitate antagonism of blockade . The incidence and severity of postoperative nausea and vomiting were assessed 24 h after operation . Nausea and vomiting were significantly reduced in group B. The incidence of nausea in group A was 68 % , compared with 32 % in group B ( P less than 0.01 ) . The incidence of vomiting was 47 % in group A , compared with 11 % in group B ( P less than 0.02 ) . A significant relationship was shown between postoperative emetic symptoms and the antagonism of neuromuscular blockade by neostigmine and atropine Eighty patients undergoing outpatient surgery under general anaesthesia were allocated r and omly to two groups : in group A residual neuromuscular block was antagonized with a mixture of neostigmine 1.5 mg and atropine 0.5 mg ; in group B spontaneous recovery was allowed . The patients were assessed after operation in hospital and 24 h after discharge . We found a significant difference ( P < 0.05 ) in requirements for antiemetic therapy with a smaller need in the group which received neostigmine ( in group A four of 40 patients received an antiemetic compared with 12 in group B ) . There was no significant difference in frequency of nausea or vomiting between the two groups . The incidence of postoperative nausea was 14 in group A and 18 in group B and the number of patients with postoperative vomiting was 10 in group A and 15 in group The study was design ed to compare the frequency and severity of postoperative vomiting in paediatric out- patients receiving controlled ventilation ( IPPV ) or breathing spontaneously ( SV ) during anaesthesia for strabismus repair . One hundred and twenty unpremedicated children ( ages 2 - 12 years ) were studied in a r and omized fashion . After intravenous induction of anaesthesia and tracheal intubation , patients breathed halothane 1 - 1.5 per cent inspired and N2O 66 per cent in O2 spontaneously ( n = 60 ) , or received IPPV , halothane 0.5 - 1 per cent , N2O 66 per cent , and pancuronium 0.05 mg.kg-1 , which was reversed with neostigmine and atropine ( n = 60 ) . The incidence of vomiting with SV was 50 per cent ( 95 per cent confidence limits : 34.5 - 65.5 per cent ) compared with 40 per cent ( 24.5 - 55.5 per cent ) with IPPV ( p > 0.25 ) . Patients in the SV group experiencing emesis had longer operations than those not vomiting ( mean ± SEM = 1.5 ± 0,1 vs 1.2 ± 0.1 hours , p < 0.005 ) . This was not the case with IPPV . There was no correlation between age , sex , duration of surgery , or number of extraocular muscles repaired , and frequency or severity of vomiting or time to discharge . No significant advantage was afforded by IPPV over SV in the present study .RésuméCette étude était conçue afin de comparer la fréquence et sévérité du vomissement post-opératoire chez les patients pédiatriques externes admis pour correction de strabisme sous anesthésie générale en respiration spontanée ( SV ) ou ventilation contrôlée ( IPPV ) . Cent vingt patients non prémédiqués âgés de 2 à 12 ans ont été étudiés ďune façon r and omisée . Après ľinduction intraveineuse de ľanesthésie et ľintubation trachéale les patients ont reçu de ľhalothane 1 - 1.5 pour cent et protoxyde ďazote 66 pour cent avec O2 soit en respiration spontanée ( n = 60 ) , soit en ventilation contrôlée de ľhalothane 0.5 - 1 pour cent , protoxyde ďazote 66 pour cent et pancuronium 0.05 mg-kg-1 , qui a été antagonisé avec la néostigmine et ľatropine ( n = 60 ) . Ľincidence de vomissement en ventilation spontanée était de 50 pour cent ( 95 pour cent limite de confiance : 34.5 - 65.5 pour cent ) comparé à 40 pour cent ( 24.5 - 55.5 pour cent ) avec IPPV ( p > 0.25 ) . Les patients du groupe SV ayant accusé des vomissements ont subi des opérations de plus longue durée que ceux qui n’en ont pas eus ( movenne ± SEM = 1.5 ± 0.1 versus 1.2 ± 0.1 heures , p < 0.005 ) . Ceci n’était pas le cas avec le groupe IPPV . Il n’y avait aucune corrélation avec ľâge , sexe , durée de la chirurgie ou le nombre de muscles extra-oculaires réparés avec la fréquence ou la sévérité des vomissements ou le temps du congé . Aucun avantage significatif n‘a acquis par la ventilation contrôlée comparativement à la ventilation spontanée dans la présente élude As professionals , we want to use the best treatments ; as patients , we want to be given them . Knowing whether an intervention works ( or does not work ) is fundamental to clinical decision making . However , clinical decision making involves more than simply taking published results of research directly to the bedside . Physicians need to consider how similar their patients are to those in the published studies , to take the values and preferences of their patients into account , and to consider their own experience with a given test or treatment . Evidence from clinical research is becoming increasingly important in medical- practice decisions as more and better evidence is published . But when is the evidence strong enough to justify changing a practice ? Individual studies that involve only small numbers of patients may have results that are distorted by the r and om play of chance and thus lead to less than optimal decisions . As is clear from other papers in this series , systematic review s identify , critically appraise , and review all the relevant studies on a clinical question and are more likely to give a valid answer . They use explicit methods and quality st and ards to reduce bias . Their results are the closest we can come to reaching the truth given our current state of knowledge . The questions about an intervention that a systematic review should answer are the following : 1 . Does it work ? 2 . If it works , how well does it work in general and compared with placebo , no treatment , or other interventions that are currently in use ? 3 . Is it safe ? 4 . Will it be safe and effective for my patients ? Whereas the critical appraisal and qualitative synthesis provided by review articles can be interpreted directly , the numerical products of quantitative review s can be more difficult to underst and and apply in daily clinical practice . This paper provides guidance on how to interpret the numerical and statistical results of systematic review s , translate these results into more underst and able terms , and apply them directly to individual patients . Many of these principles can also be used to interpret the numerical results of individual clinical studies . They are particularly relevant to systematic review s , however , because such review s contain more information than do primary studies and often exert greater influence than do individual studies . Making Sense of the Numerical Results of Clinical Studies Although the results of clinical studies can be expressed in intuitively meaningful ways , such results do not always easily translate into clinical decision making . For example , results are frequently expressed in terms of risk , which is an expression of the frequency of a given outcome . ( Risks are probabilities , which can vary between 0.0 and 1.0 . A probability of 0.0 means that the event will never happen , and a probability of 1.0 means that it always happens . ) Consider a hypothetical study of the recurrence of migraine headaches in a control group receiving placebo and a treatment group receiving a new antimigraine preparation , drug M ( a secondary prevention trial ) . Suppose that at the end of the trial , migraines recurred in 30 % of the control group ( the risk for recurrence was 0.30 ) but in only 5 % of the drug M group ( risk of 0.05 ) ( Table 1 ) . Table 1 . Numerical Expression of Hypothetical Clinical Trial Results The outcomes of the study are clear enough for the two groups when they are examined separately . But clinicians and patients are more interested in the comparative results , that is , the outcome in one group relative to the outcome in the other group . This overall ( comparative ) result can be expressed in various ways . For example , the relative risk , which is the risk in the treatment group relative to that in the control group , is simply the ratio of the risks in the two groups . In other words , relative risk is the risk in the treatment group divided by that in the control group , 0.05 0.30 , or 0.17 . The comparison can also be expressed as the reduction in relative risk , which is the ratio between the decrease in risk ( in the treatment group ) and the risk in the control group , 0.25 0.30 , or 0.83 ( Table 1 ) . ( The relative risk reduction can also be calculated as 1 relative risk ) . Although the clinical meaning of relative risk ( and relative risk reduction ) is reasonably clear , relative risk has the distinct disadvantage that a given value ( for example , 0.17 ) is the same whether the risk with treatment decreases from 0.80 to 0.14 , from 0.30 to 0.05 , from 0.001 to 0.00017 , and so forth . The clinical implication s of these changes clearly differ from one another enormously and depend on the specific disease and intervention . An important alternate expression of comparative results , therefore , is the absolute risk reduction . Absolute risk reduction is determined by subtracting the risk in one group from the risk in the other ( for example , the risk in the treatment group is subtracted from the risk in the placebo group ) . In the case of our migraine study , the absolute risk reduction would be 0.30 0.05 , which equals 0.25 , or 25 percentage points . In contrast , for a study in which the risk decreased from 0.001 to 0.00017 , the absolute risk reduction would be only 0.00083 , or 0.083 percentage points , which is a trivial change in comparison ( Table
Output:
| Omitting neostigmine may have a clinical ly relevant antiemetic effect when high doses are used .
Omitting antagonism , however , introduces a non-negligent risk of residual paralysis even with short-acting neuromuscular blocking agents |
MS213924 | ***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 r and omised trials are important for evidence -based medicine , little is known about their overall characteristics . We assessed the epidemiology and reporting of method ological details for all 519 PubMed -indexed r and omised trials published in December , 2000 ( 383 [ 74 % ] parallel-group , 116 [ 22 % ] crossover ) . 482 ( 93 % ) were published in specialty journals . A median of 80 participants ( 10th-90th percentile 25 - 369 ) were recruited for parallel-group trials . 309 ( 60 % ) were blinded . Power calculation , primary outcomes , r and om sequence generation , allocation concealment , and h and ling of attrition were each adequately described in less than half of publications . The small sample sizes are worrying , and poor reporting of method ological characteristics will prevent reliable quality assessment of many published trials Outpatient medication adherence is a major problem , especially for patients repeatedly hospitalized for psychiatric disorders . This study included 39 such patients who were receiving case management services from a community mental health center . Patients were matched and r and omly assigned to receive in a single session either ( 1 ) information regarding medication and its benefits , ( 2 ) guidelines for assuring adherence which encompassed all phases related to pill-taking including filling prescriptions , use of a pill container , transportation , self-reminders , doctor 's appointments and so forth , or ( 3 ) the same guidelines as ( 2 ) above but given in the presence of a family member who was enlisted in support . The results showed that adherence increased to about 94 % after the guidelines were given for both the individual and family guideline procedure , whereas adherence remained unchanged at 73 % after the medication information procedure . These results suggest a practical means for assuring a high level of medication adherence for patients with psychiatric disorders CONTEXT Poor medication adherence diminishes the health benefits of pharmacotherapies . Elderly patients with coronary risk factors frequently require treatment with multiple medications , placing them at increased risk for nonadherence . OBJECTIVE To test the efficacy of a comprehensive pharmacy care program to improve medication adherence and its associated effects on blood pressure ( BP ) and low-density lipoprotein cholesterol ( LDL-C ) . DESIGN , SETTING , AND PATIENTS A multiphase , prospect i ve study with an observational phase and a r and omized controlled trial conducted at the Walter Reed Army Medical Center of 200 community-based patients aged 65 years or older taking at least 4 chronic medications . The study was conducted from June 2004 to August 2006 . INTERVENTION After a 2-month run-in phase ( measurement of baseline adherence , BP , and LDL-C ) , patients entered a 6-month intervention phase ( st and ardized medication education , regular follow-up by pharmacists , and medications dispensed in time-specific packs ) . Following the intervention phase , patients were r and omized to continued pharmacy care vs usual care for an additional 6 months . MAIN OUTCOME MEASURES Primary end point of the observation phase was change in the proportion of pills taken vs baseline ; secondary end points were the associated changes in BP and LDL-C. Primary end point of the r and omization phase was the between-group comparison of medication persistence . RESULTS A total of 200 elderly patients ( 77.1 % men ; mean [ SD ] age , 78 [ 8.3 ] years ) , taking a mean ( SD ) of 9 ( 3 ) chronic medications were enrolled . Coronary risk factors included drug-treated hypertension in 184 patients ( 91.5 % ) and drug-treated hyperlipidemia in 162 ( 80.6 % ) . Mean ( SD ) baseline medication adherence was 61.2 % ( 13.5 % ) . After 6 months of intervention , medication adherence increased to 96.9 % ( 5.2 % ; P<.001 ) and was associated with significant improvements in systolic BP ( 133.2 [ 14.9 ] to 129.9 [ 16.0 ] mm Hg ; P = .02 ) and LDL-C ( 91.7 [ 26.1 ] to 86.8 [ 23.4 ] mg/dL ; P = .001 ) . Six months after r and omization , the persistence of medication adherence decreased to 69.1 % ( 16.4 % ) among those patients assigned to usual care , whereas it was sustained at 95.5 % ( 7.7 % ) in pharmacy care ( P<.001 ) . This was associated with significant reductions in systolic BP in the pharmacy care group ( -6.9 mm Hg ; 95 % CI , -10.7 to -3.1 mm Hg ) vs the usual care group ( -1.0 mm Hg ; 95 % CI , -5.9 to 3.9 mm Hg ; P = .04 ) , but no significant between-group differences in LDL-C levels or reductions . CONCLUSIONS A pharmacy care program led to increases in medication adherence , medication persistence , and clinical ly meaningful reductions in BP , whereas discontinuation of the program was associated with decreased medication adherence and persistence . TRIAL REGISTRATION clinical trials.gov Identifier : Background : Poor adherence to warfarin therapy is a major contributor to subtherapeutic anticoagulation . Objective : To determine whether use of a monthly medication organizer , filled at each clinic visit , improves anticoagulation control among warfarin-treated patients . Methods : Patients who had a history of nonadherence to warfarin and were attending an inner-city anticoagulation clinic were enrolled in this prospect i ve cohort study and provided with a 28-day medication organizer . Patients were instructed to bring their organizers and warfarin tablets to each anticoagulation clinic visit over the following 3 months . At each visit , the international normalized ratio ( INR ) was measured , warfarin adherence was assessed , and the organizer was filled with the prescribed warfarin regimen until the next scheduled visit . Data on warfarin adherence and INR values during the 3 months prior to enrollment were collected from medical records and compared with postenrollment data . Results : Thirteen patients were enrolled and completed at least one postenrollment clinic visit . Adherence to warfarin therapy improved with use of the medication organizer ( mean ± SD preenrollment 55 ± 25 % , postenrollment 67 ± 21 % ; p = 0.06 ) . There was a significant decrease in the proportion of subtherapeutic INR values ( 60 ± 25 % to 35 ± 29 % ; p = 0.04 ) and a significant improvement in the percent of time spent within the therapeutic INR range ( 32 ± 22 % to 56 ± 28 % ; p = 0.03 ) after enrollment . Conclusions : Use of a monthly medication organizer significantly reduced the percent of subtherapeutic INR values and improved the time spent within the therapeutic anticoagulation range among previously nonadherent patients managed in an inner-city anticoagulation clinic A study was design ed for practitioners wishing to provide comprehensive educational services to the elderly . The effectiveness of four methods ( i.e. , oral instructions alone or in combination with written information , a medication reminder calendar , or a medication reminder package ) of changing patient attitudes , drug knowledge , and compliance behavior was measured in 158 ambulatory cardiovascular patients using a r and omized , controlled , single-blind design . The results indicate that drug knowledge will most likely be improved by a strategy that provides small amounts of specific information , thereby reducing the possibility of overwhelming the patient . Noncompliance behavior caused by forgetfulness can be best improved by combining a reminder aid with oral reinforcement . The high levels of motivation present in these patients indicate that improving patient attitudes toward medication taking may be unnecessary An estimated 20 million Americans suffer from diabetes . Patients with non-insulin-dependent diabetes mellitus ( NIDDM ) comprise approximately 90 % of the diabetic population . An estimated 10 - 30 % of patients with NIDDM withdraw from their prescribed regimen within 1 year of diagnosis , and of the remainder , nearly 20 % administer insufficient medication to facilitate an adequate reduction in blood glucose . A r and omized trial was undertaken to discern the effect of pharmacy-based value-added utilities on prescription-refill compliance with sulfonylurea therapy and health service utilization . The subjects were 258 Medicaid beneficiaries from the state of South Carolina , previously untreated for NIDDM , prescribed 5 mg of the second-generation sulfonylurea glyburide twice daily , and monitored with regard to prescription-refill compliance and health service utilization for 1 year . Subjects provided informed consent and were r and omly assigned to one of four experimental groups : ( i ) the control cohort received st and ard pharmaceutical care with each dispensing of glyburide ; ( ii ) the second cohort received st and ard pharmaceutical care and was mailed a medication-refill reminder 10 days prior to each sequential refill date ; ( iii ) the third cohort received st and ard pharmaceutical care and was provided unit-of-use packaging with each prescription-refill request ; ( iv ) the fourth cohort received st and ard pharmaceutical care , mailed medication-refill reminders , and unit-of-use packaging . Analysis of variance ( ANOVA ) procedures revealed that patients receiving mailed prescription-refill reminders , unit-of-use packaging , or a combination of both interventions achieved a significant ( P < or = 0.05 ) increase in the Medication Possession Ratio ( MPR ) for sulfonylurea therapy relative to controls . ( ABSTRACT TRUNCATED AT 250 WORDS Adequate reporting of r and omized , controlled trials ( RCTs ) is necessary to allow accurate critical appraisal of the validity and applicability of the results . The CONSORT ( Consoli date d St and ards of Reporting Trials ) Statement , a 22-item checklist and flow diagram , is intended to address this problem by improving the reporting of RCTs . However , some specific issues that apply to trials of nonpharmacologic treatments ( for example , surgery , technical interventions , devices , rehabilitation , psychotherapy , and behavioral intervention ) are not specifically addressed in the CONSORT Statement . Furthermore , considerable evidence suggests that the reporting of nonpharmacologic trials still needs improvement . Therefore , the CONSORT group developed an extension of the CONSORT Statement for trials assessing nonpharmacologic treatments . A consensus meeting of 33 experts was organized in Paris , France , in February 2006 , to develop an extension of the CONSORT Statement for trials of nonpharmacologic treatments . The participants extended 11 items from the CONSORT Statement , added 1 item , and developed a modified flow diagram . To allow adequate underst and ing and implementation of the CONSORT extension , the CONSORT group developed this elaboration and explanation document from a review of the literature to provide examples of adequate reporting . This extension , in conjunction with the main CONSORT Statement and other CONSORT extensions , should help to improve the reporting of RCTs performed in this field OBJECTIVES To determine whether an enhanced compliance program ( ECP ) improves patient compliance with bismuth subsalicylate , metronidazole , and tetracycline hydrochloride ( BMT ) triple therapy for the treatment of Helicobacter pylori infection and to identify factors that affect compliance with therapy . DESIGN A r and omized controlled trial conducted in 4 staff-model health centers of a health maintenance organization in Massachusetts . PATIENTS AND METHODS A total of 125 patients 18 years of age or older with peptic ulcer disease or dyspepsia whose clinicians prescribed BMT triple therapy for 14 days were r and omized to a control group or to the ECP group . The ECP group received medication counseling ( written and oral ) from a pharmacist , along with a medication calendar and a minipillbox , as well as a follow-up telephone call after initiation of therapy . Compliance was assessed by a pill count , and factors affecting adherence to the regimen were identified by patients ' reports . RESULTS There was no statistically significant difference between the 2 groups in the number of patients taking more than 60 % of the medications ( 89 % of the control group vs 95 % of the ECP group ; P>.30 ) . However , there was a statistically significant difference in the number of patients taking more than 90 % of the medications ( 67 % of the control group vs 89 % of the ECP group ; P<.01 ) . An intention-to-treat analysis confirmed these results . The most frequently reported adverse effect was gastrointestinal intolerance . Other factors reported to affect compliance included the frequency of dosing and the number of pills . CONCLUSIONS These findings suggest that although adverse effects were common , most patients were able to complete 60 % or more of the 2-week regimen . An ECP further improved the percentage of medications taken Background : Similar to patients with other chronic disorders , patients with serious mental illness ( SMI ) are often poorly adherent with prescribed medications . Objective : We conducted a r and omized controlled trial examining the effectiveness of a pharmacy-based intervention ( Meds-Help ) in increasing antipsychotic medication adherence among Department of Veterans Affairs ( VA ) patients with SMI . We also examined the impact of Meds-Help on psychiatric symptoms , quality of life , and satisfaction with care . Methods : We enrolled 118 patients from 4 VA facilities
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| Conclusions Overall , the studies showed a positive effect of drug reminder packaging on adherence and clinical outcomes . |
MS213925 | ***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 determine whether obesity is associated with the frailty phenotype and , if so , whether comorbid conditions or inflammatory markers explain this association . DESIGN Cross-sectional analysis of baseline data from the Women 's Health and Aging Studies I ( 1992 ) and II ( 1994 ) , complementary population -based studies . SETTING Twelve contiguous ZIP code areas in Baltimore , Maryl and . PARTICIPANTS Five hundred ninety-nine community-dwelling women aged 70 to 79 with a body mass index ( BMI ) greater than 18.5 kg/m(2 ) . MEASUREMENTS The dependent variables were the frailty syndrome , including prefrailty , defined as presence of one or two of five frailty indicators ( weakness , slowness , weight loss , low physical activity , exhaustion ) , and frailty , defined as three or more indicators . Independent variables included BMI , categorized using World Health Organization criteria as normal ( 18.5 to < 25 kg/m(2 ) ) , overweight ( 25 to < 30 kg/m(2 ) ) , and obese ( > /=30 kg/m(2 ) ) ; chronic diseases ; C-reactive protein ; and serum carotenoids . RESULTS Being overweight was significantly associated with prefrailty , and obesity was associated with prefrailty and frailty . In all frail women , regardless of BMI group , a similar pattern of three defining frailty indicators was found : slowness , weakness , and low activity ( with the addition of weight loss in the normal weight group . ) In multinomial regression models , obesity was significantly associated with prefrailty ( odds ratio (OR)=2.23 , 95 % confidence interval (CI)=1.29 - 3.84 ) and frailty ( OR=3.52 , 95 % CI=1.34 - 9.13 ) , even when controlling for covariates . CONCLUSION Obesity is associated with the frailty syndrome in older women in cross-sectional data . This association remains significant even when multiple conditions associated with frailty are considered . Prospect i ve studies are needed to confirm this finding Body composition and the components of energy metabolism were examined in 12 men and women , aged 56 - 80 y , before and after 12 wk of resistance training . Subjects were r and omly assigned to groups that consumed diets that providing either 0.8 or 1.6 g protein.kg-1.d-1 and adequate total energy to maintain baseline body weight . Fat mass decreased 1.8 + /- 0.4 kg ( P < 0.001 ) and fat-free mass ( FFM ) increased 1.4 + /- 0.4 kg ( P < 0.01 ) in these weight-stable subjects . The increase in FFM was associated with a 1.6 + /- 0.4 kg increase in total body water ( P < 0.01 ) but no significant change in either protein plus mineral mass or body cell mass . With resistance training , the mean energy intake required for body weight maintenance increased by approximately 15 % . Increased energy expenditure included increased resting metabolic rate ( P < 0.02 ) and the energy cost of resistance exercise . Dietary protein intake did not influence these results . Resistance training is an effective way to increase energy requirements , decrease body-fat mass , and maintain metabolically active tissue mass in healthy older people and may be useful as an adjunct to weight-control programs for older adults Background and aim Physical frailty has been regarded as a precursor state to disability and dependence on others for daily activities . Frail individuals are considered to be the group of patients that presents the most complex and challenging problems to health care professionals . The purpose of this study was to evaluate whether a 12-week functional circuit training program ( FCT ) could reduce self-reported fear of falling and improve health status in a group of physically frail community-dwelling older individuals . Methods Fifty-one individuals ( 31 F , 20 M ) , mean age ( SD ) 84 ( 2.9 ) years old , were considered frail and tested at week 0 and r and omly assigned into two groups ( intervention group , FCT = 26 ; control group , CG = 25 ) . FCT underwent a structured 12-week FCT program , which focused on a combination of functional balance and lower-body strength-based exercises . CG met once a week for health education meetings . Measures of self-reported fear of falling ( Activities-specific Balance Confidence scale ) and health status ( SF-12 ) were assessed at week 0 , 12 and 36 . All longitudinal analyses for continuous variables that were measured at the three time points ( week 0 , 12 and 36 ) were performed using linear mixed modeling . Results FCT participants had greater improvements than those in the CG in fear of falling and self-reported physical function , physical composite score and mental composite score ; these improvements were maintained in the week 36 follow-up , with significant group-by-time interactions by the end of the study . Conclusions These data indicate that a FCT program is effective in improving self-reported measures of fear of falling and health status in a group of physically frail individuals BACKGROUND AND PURPOSE Systematic review s and meta-analyses often include an evaluation of the method ological quality of the individual studies that have been included , and are usually conducted by at least 2 individuals . The objective of this study was to assess the method ological quality and reliability of a series of r and omized controlled trials ( RCTs ) of both pharmacological and nonpharmacological interventions by use of the 10-item Physiotherapy Evidence -Based Data base ( PEDro ) Scale . METHODS Two abstract ors independently review ed 81 RCTs assessing a variety of interventions . The Cohen kappa statistic and the intraclass correlation coefficient ( ICC ) were used to assess agreement between abstract ors . RESULTS The average total PEDro scores were 5.94 ( SD=1.43 ) for all studies combined , 6.88 ( SD=1.2 ) for pharmacological studies , and 5.29 ( SD=1.26 ) for nonpharmacological studies . The median score for pharmacological studies was significantly higher than that for nonpharmacological studies ( 7 versus 5 ) . Pair-wise kappa scores ranged from a low of .452 for concealed allocation among drug trials to perfect agreement ( 1.00 ) for r and omization and reporting of results from between-group comparisons . The ICCs associated with the cumulative PEDro score were .91 ( 95 % confidence interval [CI]=.83-.94 ) for all studies , .89 ( 95 % CI=.78-.95 ) for pharmacological studies , and .91 ( 95 % CI=.84-.952 ) for nonpharmacological studies . DISCUSSION AND CONCLUSION The method ological quality for pharmacological interventions was significantly higher than that for nonpharmacological interventions . There was good agreement between raters at an individual item level and in total PEDro scores . A lack of reporting clarity , poor organization of the report , or the failure to include salient details contributed to less-than-perfect agreement between raters BACKGROUND frail older people have a high risk of falling . OBJECTIVE assess the effect of a frailty intervention on risk factors for falls and fall rates in frail older people . DESIGN r and omised controlled trial . PARTICIPANTS 241 community-dwelling people aged 70 + without severe cognitive impairment who met the Cardiovascular Health Study frailty definition . INTERVENTION multifactorial , interdisciplinary intervention targeting frailty characteristics with an individualised home exercise programme prescribed in 10 home visits from a physiotherapist and interdisciplinary management of medical , psychological and social problems . MEASUREMENTS risk factors for falls were measured using the Physiological Profile Assessment ( PPA ) and mobility measures at 12 months by a blinded assessor . Falls were monitored with calendars . RESULTS participants had a mean ( SD ) age of 83.3 ( 5.9 ) years , 68 % were women and 216 ( 90 % ) completed the study . After 12 months the intervention group had significantly better performance than the control group , after controlling for baseline values , in the PPA components of quadriceps strength ( between-group difference 1.84 kg , 95 % CI 0.17 - 3.51 , P = 0.03 ) and body sway ( -90.63 mm , 95 % CI -168.6 to -12.6 , P = 0.02 ) , short physical performance battery ( 1.58 , 95 % CI 1.02 - 2.14 , P ≤ 0.001 ) and 4 m walk ( 0.06 m/s 95 % CI 0.01 - 0.10 , P = 0.02 ) with a trend toward a better total PPA score ( -0.40 , 95 % CI -0.83 - 0.04 , P = 0.07 ) but no difference in fall rates ( incidence rate ratio 1.12 , 95 % CI 0.78 - 1.63 , P = 0.53 ) . CONCLUSION the intervention improved performance on risk factors for falls but did not reduce the rate of falls . TRIAL REGISTRATION ACTRN12608000250336 OBJECTIVES To determine the effects of moderate intensity group-exercise programs on falls , functional performance , and disability in older adults ; and to investigate the influence of frailty on these effects . DESIGN A 20-week , multicenter r and omized controlled trial , with 52-week follow-up . SETTING Fifteen homes for the elderly . PARTICIPANTS Two hundred seventy-eight men and women ( mean age + /- st and ard deviation , 85+/-6y ) . INTERVENTIONS Two exercise programs were r and omly distributed across 15 homes . The first program , functional walking ( FW ) , consisted of exercises related to daily mobility activities . In the second program , in balance ( IB ) , exercises were inspired by the principles of Tai Chi . Within each home participants were r and omly assigned to an intervention or a control group . Participants in the control groups were asked not to change their usual pattern of activities . The intervention groups followed a 20-week exercise program with 1 meeting a week during the first 4 weeks and 2 meetings a week during the remaining weeks . MAIN OUTCOME MEASURES Falls , Performance Oriented Mobility Assessment ( POMA ) , physical performance score , and the Groningen Activity Restriction Scale ( GARS ) ( measuring self-reported disability ) . RESULTS Fall incidence rate was higher in the FW group ( 3.3 falls/y ) compared with the IB ( 2.4 falls/y ) and control ( 2.5 falls/y ) groups , but this difference was not statistically significant . The risk of becoming a faller in the exercise groups increased significantly in the subgroup of participants who were classified as being frail ( hazard ratio [ HR ] = 2.95 ; 95 % confidence interval [ CI ] , 1.64 - 5.32 ) . For participants who were classified as being pre-frail , the risk of becoming a faller decreased ; this effect became significant after 11 weeks of training ( HR = .39 ; 95 % CI , .18-.88 ) . Participants in both exercise groups showed a small , but significant improvement in their POMA and physical performance scores . In the FW group , this held true for the GARS score as well . Post hoc analyses revealed that only the pre-frail participants improved their POMA and physical performance scores . CONCLUSIONS Fall-preventive moderate intensity group-exercise programs have positive effects on falling and physical performance in pre-frail , but not in frail elderly BACKGROUND Little is known about the natural course of frailty . We performed a prospect i ve study to determine the transition rates between frailty states and to evaluate the effect of the preceding frailty state on subsequent frailty transitions . METHODS We studied 754 community-living persons , aged 70 years or older , who were nondisabled in 4 essential activities of daily living . Frailty , assessed every 18 months for 54 months , was defined on the basis of weight loss , exhaustion , low physical activity , muscle weakness , and slow walking speed . Participants were classified as frail if they met 3 or more of these criteria , as prefrail if they met 1 or 2 of the criteria , and as nonfrail if they met none of the criteria . RESULTS Of the 754 participants , 434 ( 57.6 % ) had at least 1 transition between any 2 of the 3 frailty states during 54 months . The rates were 36.8 % , 21.5 % , and 9.2 % for 1 , 2 , and 3 transitions , respectively . During the 18-month intervals , transitions to states of greater frailty were more common ( rates up to 43.3 % ) than transitions to states of lesser frailty ( rates up to 23.0 % ) , and the probability of transitioning from being frail to nonfrail was very low ( rates , 0%-0.9 % ) , even during an extended period . The likelihood of transitioning between frailty states was highly dependent on one 's preceding frailty state . CONCLUSIONS Frailty among older persons is a dynamic process , characterized by frequent transitions between frailty states over time . Our findings suggest ample opportunity for the prevention and remediation of frailty Low-intensity ( ~50 % of a single repetition maximum—1 RM ) resistance training combined with vascular occlusion results in increases in muscle strength and cross-sectional area [ Takarada et al. ( 2002 ) Eur J Appl Physiol 86:308–331 ] . The mechanisms responsible for this hypertrophy and strength gain remain elusive and no study has assessed the contribution of neuromuscular adaptations to these strength gains . We examined the effect of low-intensity training ( 8
Output:
| Conclusions This systematic review suggested that frail older adults seemed to benefit from exercise interventions , although the optimal program remains unclear . |
MS213926 | ***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 —Cigarette smoking causes endothelial dysfunction , possibly through increased oxidant stress . The enzyme xanthine oxidase produces oxidative free radicals . We tested the hypothesis that xanthine oxidase contributes to endothelial dysfunction in cigarette smokers by administering the inhibitor allopurinol . Methods and Results —Fourteen cigarette smokers ( 31±4 pack years ) and 14 age- and sex-matched healthy non-smoking control subjects participated in a single-blinded , r and omized , 2-phase crossover study . All subjects had no other risk factors for atherosclerosis . Inhibition of xanthine oxidase was achieved by a single oral dose of 600 mg of allopurinol on the day of the study . Stimulated nitric oxide endothelial responses were assessed by forearm blood flow responses to intraarterial administration of acetylcholine and bradykinin 4 to 7 hours later ; basal nitric oxide was assessed using the nitric oxide synthase inhibitor NG-monomethyl-l-arginine ( L-NMMA ) ; and nitroprusside was used to assess sensitivity to nitric oxide . Dilatation produced by acetylcholine was significantly less in smokers ( 254±57 % ) than healthy controls ( 390±55 % ) ( P = 0.009 ) . Allopurinol reversed endothelial dysfunction in smokers ( acetylcholine , 463±78 % , P = 0.001 ) without affecting responses in non-smokers ( 401±80 % ) . Bradykinin responses were also impaired in smokers ( P = 0.003 ) , and improved with allopurinol , though not significantly ( P = 0.06 ) . Responses to nitroprusside and L-NMMA were not significantly different between smokers and controls and were not altered by allopurinol . Conclusions —Smoking-induced endothelial dysfunction of resistance vessels is rapidly reversed with oral allopurinol . These data suggest that xanthine oxidase contributes importantly to endothelial dysfunction caused by cigarette smoking Background —Endothelial function is impaired in coronary artery disease and may contribute to its clinical manifestations . Increased oxidative stress has been linked to impaired endothelial function in atherosclerosis and may play a role in the pathogenesis of cardiovascular events . This study was design ed to determine whether endothelial dysfunction and vascular oxidative stress have prognostic impact on cardiovascular event rates in patients with coronary artery disease . Methods and Results —Endothelium-dependent and -independent vasodilation was determined in 281 patients with documented coronary artery disease by measuring forearm blood flow responses to acetylcholine and sodium nitroprusside using venous occlusion plethysmography . The effect of the coadministration of vitamin C ( 24 mg/min ) was assessed in a subgroup of 179 patients . Cardiovascular events , including death from cardiovascular causes , myocardial infa rct ion , ischemic stroke , coronary angioplasty , and coronary or peripheral bypass operation , were studied during a mean follow-up period of 4.5 years . Patients experiencing cardiovascular events ( n=91 ) had lower vasodilator responses to acetylcholine ( P < 0.001 ) and sodium nitroprusside ( P < 0.05 ) , but greater benefit from vitamin C ( P < 0.01 ) . The Cox proportional regression analysis for conventional risk factors demonstrated that blunted acetylcholine-induced vasodilation ( P = 0.001 ) , the effect of vitamin C ( P = 0.001 ) , and age ( P = 0.016 ) remained independent predictors of cardiovascular events . Conclusions —Endothelial dysfunction and increased vascular oxidative stress predict the risk of cardiovascular events in patients with coronary artery disease . These data support the concept that oxidative stress may contribute not only to endothelial dysfunction but also to coronary artery disease activity Background —Dilated cardiomyopathy is characterized by an imbalance between left ventricular performance and myocardial energy consumption . Experimental models suggest that oxidative stress result ing from increased xanthine oxidase ( XO ) activity contributes to this imbalance . Accordingly , we hypothesized that XO inhibition with intracoronary allopurinol improves left ventricular efficiency in patients with idiopathic dilated cardiomyopathy . Methods and Results — Patients ( n=9 ; ejection fraction , 29±3 % ) were instrumented to assess myocardial oxygen consumption ( M&OV0312;o2 ) , peak rate of rise of left ventricular pressure ( dP/dtmax ) , stroke work ( SW ) , and efficiency ( dP/dtmax/M&OV0312 ; o2 and SW/M&OV0312;o2 ) at baseline and after sequential infusions of intracoronary allopurinol ( 0.5 , 1.0 , and 1.5 mg/min , each for 15 minutes ) . Allopurinol caused a significant decrease in M&OV0312;o2 ( peak effect , −16±5%;P < 0.01 ; n=9 ) with no parallel decrease in dP/dtmax or SW and no change in ventricular load . The net result was a substantial improvement in myocardial efficiency ( peak effects : dP/dtmax/M&OV0312 ; o2 , 22±9 % , n=9 ; SW/M&OV0312 ; o2 , 40±17 % , n=6 ; both P < 0.05 ) . These effects were apparent despite concomitant treatment with st and ard heart failure therapy , including ACE inhibitors and & bgr;-blockers . XO and its parent enzyme xanthine dehydrogenase were more abundant in failing explanted human myocardium on immunoblot . Conclusions —These findings indicate that XO activity may contribute to abnormal energy metabolism in human cardiomyopathy . By reversing the energetic inefficiency of the failing heart , pharmacological XO inhibition represents a potential novel therapeutic strategy for the treatment of human heart failure Background and Purpose — Elevated serum uric acid level is associated with poor outcome and increased risk of recurrent events after stroke . The xanthine oxidase inhibitor allopurinol lowers uric acid but also attenuates expression of inflammatory adhesion molecules in murine models , reduces oxidative stress in the vasculature , and improves endothelial function . We sought to investigate whether allopurinol alters expression of inflammatory markers after acute ischemic stroke . Methods — We performed a r and omized , double-blind , placebo-controlled trial to investigate the safety , tolerability , and effect of 6 weeks ' treatment with high- ( 300 mg once a day ) or low- ( 100 mg once a day ) dose allopurinol on levels of uric acid and circulating inflammatory markers after ischemic stroke . Results — We enrolled 50 patients with acute ischemic stroke ( 17 , 17 , and 16 in the high , low , and placebo groups , respectively ) . Mean ( ±SD ) age was 70 ( ±13 ) years . Groups had similar characteristics at baseline . There were no serious adverse events . Uric acid levels were significantly reduced at both 7 days and 6 weeks in the high-dose group ( by 0.14 mmol/L at 6 weeks , P=0.002 ) . Intercellular adhesion molecule-1 concentration ( ng/mL ) rose by 51.2 in the placebo group , rose slightly ( by 10.6 ) in the low-dose allopurinol group , but fell in the high-dose group ( by 2.6 ; difference between groups P=0.012 , Kruskal-Wallis test ) . Conclusion — Allopurinol treatment is well tolerated and attenuates the rise in intercellular adhesion molecule-1 levels seen after stroke . Uric acid levels were lowered with high doses . These findings support further evaluation of allopurinol as a preventive measure after stroke Increased oxidative stress in obstructive sleep apnoea is thought to contribute to endothelial dysfunction . The objective of this study was to test the hypothesis that inhibition of xanthine oxidase by allopurinol can improve endothelial function in patients with obstructive sleep apnoea . A r and omised double-blind placebo-controlled crossover study was performed on 12 patients with moderate-to-severe obstructive sleep apnoea , comparing 300 mg allopurinol daily for 2 weeks with placebo . Endothelial function was assessed using hyperaemia-induced flow-mediated vasodilation ( FMD ) at baseline and following treatment . Plasma malondialdehyde levels were compared in order to assess significant changes in oxidative stress . Baseline FMD correlated significantly with the severity of sleep apnoea and the time spent with an arterial oxygen saturation of < 90 % . Allopurinol caused a significant increase in FMD compared to placebo ( 10.4±3.2 versus 7.4±2.8 % , respectively ) . Plasma malondialdehyde levels were significantly reduced with allopurinol treatment ( 1.5±0.3 versus 1.2±0.3 μmol·L−1 ) , consistent with reduced oxidative stress . Allopurinol improves endothelial dysfunction in patients with moderate-to-severe obstructive sleep apnoea . These observations suggest that xanthine oxidase contributes significantly to vasodilatory impairment AIMS Allopurinol improves endothelial function in chronic heart failure by reducing oxidative stress . We wished to explore if such an effect would attenuate autonomic dysfunction in CHF in line with many other effective therapies in CHF . METHODS We performed a prospect i ve , r and omized , double-blind cross-over study in 16 patients with NYHA Class II-IV chronic heart failure ( mean age 67 + /- 10 years , 13 male , comparing allopurinol ( 2 months ) at a daily dose of 300 mg ( if creatinine < 150 micromol l-1 ) or 100 mg ( if creatinine > 150 micromol l-1 ) with matched placebo . Mean heart rate and dysrhythmia counts were recorded from 24 h Holter tapes at monthly intervals for 6 months . We assessed autonomic function using st and ard time domain heart rate variability parameters ( HRV ) : SDNN , SDANN , SDNN index , rMSSD and TI . RESULTS Allopurinol had no significant effect on heart rate variability compared with placebo ; the results are expressed as a difference in means + /- s.d . with 95 % confidence interval ( CI ) between allopurinol and placebo : SDNN mean = 6.5 + /- 4.8 ms , P = 0.18 and 95 % CI ( -3.7 , 17 ) ; TI mean = -2.1 + /- 1.4 , P = 0.16 and 95 % CI ( -5.2 , 0.8 ) ; SDANN mean = -2.8 + /- 7 ms , P = 0.68 and 95 % CI ( -18 , 12 ) ; SDNNi mean = 2 + /- 6.6 , P = 0.7 and 95 % CI ( -12 , 16 ) ; RMSSD mean = -0.9 + /- 2 , P = 0.68 and 95 % CI ( -5.6 , 3.7 ) . For mean heart rate the corresponding results were 0.9 + /- 1.4 , P = 0.5 and 95 % CI ( -2 , 3.8 ) . Log 24 h ventricular ectopic counts ( VEC ) were 0.032 + /- 0.37 , P = 0.7 and 95 % CI ( -0.1 , 0.2 ) . Patient compliance with study medication was good since allopurinol showed its expected effect of reducing plasma uric acid ( P < 0.001 ) . CONCLUSIONS Allopurinol at doses , which are known to reduce oxidative stress appear to have no significant effect on resting autonomic tone , as indicated by time domain heart rate variability or on dysrhythmia count in stable heart failure patients Background —In patients with chronic heart failure ( CHF ) , hyperuricemia is a common finding and is associated with reduced vasodilator capacity and impaired peripheral blood flow . It has been suggested that the causal link of this association is increased xanthine oxidase (XO)–derived oxygen free radical production and endothelial dysfunction . We therefore studied the effects of XO inhibition with allopurinol on endothelial function and peripheral blood flow in CHF patients after intra-arterial infusion and after oral administration in 2 independent placebo-controlled studies . Methods and Results —In 10 CHF patients with normal serum uric acid ( UA ) levels ( 315±42 & mgr;mol/L ) and 9 patients with elevated UA ( 535±54 & mgr;mol/L ) , endothelium-dependent ( acetylcholine infusion ) and endothelium-independent ( nitroglycerin infusion ) vasodilation of the radial artery was determined . Coinfusion of allopurinol ( 600 & mgr;g/min )
Output:
| XOI improves endothelial function and circulating markers of oxidative stress in patients with , or at risk of , cardiovascular disease . |
MS213927 | ***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: Fifty-five r and omly selected community pharmacy patrons were surveyed regarding their preferences between four different prescription labels . The variables displayed on the four labels were : ( i ) laser printed , ( ii ) dot-matrix printed , ( iii ) glossy surface , and ( iv ) matt surface . The study population was stratified by age and gender . Statistical analysis of the results indicated a clear preference by all groups for the laser printed labels ( P less than 0.001 ) , and the only other statistically significant finding was the preference for the matt surface ( P less than 0.05 ) of females between the ages of 16 and 39 . The implication s for these differences on label readability are discussed , and recommendations are offered for the use of improved laser technology for computer-generated prescription labels Despite the proven benefits of statins , large numbers of patients meeting guideline criteria for therapy are not receiving these drugs . It has been suggested that over-the-counter ( OTC ) availability of statins would allow more consumers to use statins and achieve cardiovascular risk reduction . However , concerns have been raised as to the consumers ' ability to self-manage hyperlipidemia and use statins safely . The Consumer Use Study of OTC Mevacor ( CUSTOM ) was design ed to define consumer behaviors in the setting of OTC statin availability . The study was conducted in a simulated OTC setting and allowed consumers to purchase once-daily lovastatin 20 mg . The CUSTOM data set includes > 3,300 consumers who evaluated OTC lovastatin for potential purchase at study sites and follow-up information on purchasers for up to 6 months of self-managed therapy . These data have been analyzed to address consumers ' knowledge of their cholesterol concentrations as well as their ability to make OTC use decisions based on their cardiovascular risk , avoid drug-drug interactions , self-manage their cholesterol treatment after deciding to use the OTC product , and maintain interactions with physicians while using lovastatin OTC . The results showed that most study participants appropriately self-selected OTC statin therapy and managed their treatment . Use of OTC statins by consumers needing more intensive statin therapy or facing the risk of potential drug-drug interactions remains an area of concern but occurred infrequently in CUSTOM . These data are important for making an informed risk-benefit decision concerning OTC statin availability Background : Nearly perfect compliance seems to be indispensable to obtain the maximum benefit from highly active antiretroviral therapy ( HAART ) . Interventions to ensure a high level of adherence during a relatively long‐term period of therapy are necessary . Methods : This is a prospect i ve , r and omized , two‐arm controlled study including patients starting their first‐ or second‐line HAART who were r and omized to receive psychoeducative intervention to implement adherence ( experimental group [ EG ] ) or a usual medical follow‐up ( control group [ CG ] ) . We aim ed to study the efficacy of a psychoeducative intervention to ensure long‐term adherence to HAART , its relation with the virologic efficacy of treatment , and to determine the variables related to long‐term adherence . Visits were made at weeks 0 , 4 , 24 , and 48 for data collection . Self‐reported adherence was registered at each visit and its veracity was tested by r and omized blood analyses performed without previous warning to 40 % of patients . Appropriate adherence was defined as the consumption of ≥95 % of medication prescribed . Statistical analyses were performed both by the as treated ( AT ) and the intention to treat missing = failure ( ITT ) methods . Results : In all , 116 patients were included . At week 48 , 94 % of patients in the EG versus 69 % controls achieved adherence ≥95 % ( p = .008 ) ; 89 % of patients in the EG versus 66 % controls had HIV‐1 RNA levels < 400 copies/ml ( p = .026 ) . Overall , 85 % of patients with adherence ≥95 % but only 45 % of those with adherence < 95 % had viral load ( VL ) < 400 copies/ml ( p = .008 ) . In multivariate analysis , variables significantly related to adherence were having received a psychoeducative intervention ( odds ratio [ OR ] , 6.58 ; p = .04 ) , poor effort to take medication ( OR , 5.38 ; p = .03 ) , and high self‐perceived capacity to follow the regimen ( OR , 13.76 ; p = .04 ) . Self‐reported adherence and drug plasma levels coincided in 93 % of cases . However , differences in adherence did not reach statistical significance in the ITT analysis although a clear tendency toward benefit was observed in EG . Conclusions : Specific and maintained psychoeducative interventions based on excellence on clinical practice are useful to keep high levels of adherence as well as high levels of viral suppression . There is a clear relation between high adherence levels and virologic success . Assessment of certain specific variables related to adherence may be helpful to monitor patient 's compliance in the clinical setting OBJECTIVES The authors determined patients ' report of prescription drug counseling activities after withdrawal of the pilot program to require patient package inserts in 1980 and implementation of Omnibus Budget Reconciliation Act of 1990 counseling requirements in 1993 . METHODS Four cross-sectional national telephone surveys were conducted in the fall of 1982 , 1984 , 1992 , and 1994 . Telephone households were chosen by r and om-digit dialing . Subjects had obtained a new prescription for themselves or for a family member at a retail pharmacy during the previous 4 weeks . Verbal counseling rates at physician offices and pharmacies for five information categories and the distribution of written information at those locations were determined . RESULTS Spontaneous verbal counseling at the physician 's office has increased slightly , with the largest increases focused on the delivery of side effect and pre caution ary information . Slightly larger increases in pharmacy-delivered information regarding directions for use and pre caution s have occurred . Patient question ing has remained at single digit levels at both sites . The percentage of patients receiving any written information has increased from 5 % to 15 % at the physician 's office and from 16 % to 59 % at the pharmacy . CONCLUSIONS The data indicate small increases in verbal counseling but larger increases in the delivery of written information provided at the pharmacy . In light of Healthy People : 2000 goals for patient counseling and legislation encouraging private-sector initiatives , these data should help to refocus attention on the continuing need for effective patient education interventions Direct-to-consumer ( DTC ) pharmaceutical ads typically describe drug benefits in qualitative terms ; they rarely provide data on how well the drug works . We describe an evaluation of a " prescription drug benefit box"- data from the main r and omized trials on the chances of various outcomes with and without the drug . Most participants rated the information as " very important " or " important " ; almost all found the data easy to underst and . Perceptions of drug effectiveness were much lower for ads that incorporated the benefit box than for ads that did not . Most people we interviewed want benefit data in drug ads , can underst and these data , and are influenced by them Objective To determine how well patients could correctly recognize and comprehend the various information items on patient information leaflets , and to explore the reasons underlying poor comprehensibility . Methods Leaflets from 30 r and omly selected , commonly prescribed medicines were examined by experts using protocol s to evaluate leaflet layout , language and content . The same leaflets were also evaluated by patients who had their medicines dispensed at 24 r and omly selected Swedish pharmacies . A question naire was used for the patients ’ examination . Results The results showed that most information on the leaflets is sound and is well comprehended by the patients . For two information items regarding ’ risks of interactions ’ and ’ contraindications ’ the patient scores were low , indicating poor comprehensibility . Conclusion Leaflets with low scores on warnings of interactions and contraindications were found to deliver more complex messages to older patients as compared to leaflets with high scores for these items The objective was to determine the influence of medicine labels incorporating pictograms on the underst and ing of instructions and on adherence . Eighty-seven Xhosa participants attending an outpatient clinic who had been prescribed a short course of antibiotics were r and omly allocated to either a control group ( 41 participants given text-only labels ) , or an experimental group ( 46 participants given text + pictogram labels ) . All participants had a maximum of 10 years of formal schooling . Follow-up home visits were conducted after 3 - 5 days to assess underst and ing of instructions and to evaluate adherence . A high adherence of greater than 90 % was found for 54 % of the experimental group , compared with only 2 % of the control group . Average percentages for underst and ing in the control and experimental groups were 70 and 95 % , respectively , and average adherence was 72 and 90 % , respectively . The presence of pictograms was found to contribute positively to both underst and ing of instructions and adherence OBJECTIVE : To design , develop , and evaluate a simple , underst and able medicine label and patient information leaflet ( PIL ) for nystatin suspension , and to assess the effect of incorporating pictograms on underst and ing in low-literate participants . METHODS : Patient information material s were design ed and pretested in a pilot study ( n = 20 ) , and were subjected to the Fry 's readability test . The final evaluation was conducted with 60 low-literate participants who had a maximum of 7 years of formal schooling and for whom English was their second language . Demographic data were collected . Participants were r and omly allocated to a control ( text-only information ) or experimental ( text + pictogram information ) group , shown the medicine label and PIL , and asked to read them . A series of questions was asked about the instructions and an underst and ing level was calculated in each case . A second series of questions assessed patient acceptability of the material s. Differences in underst and ing were determined by χ2 tests . RESULTS : Both sets of these simple written material s were generally well understood . However , the presence of pictograms was shown to improve the comprehension of more complex information , result ing in significantly more participants in the experimental group obtaining a score for underst and ing > 80 % for both the medicine label and PIL . A clear preference for the material s incorporating pictograms was expressed . CONCLUSIONS : The presence of pictograms had a positive effect in the acquisition and comprehension of drug information BACKGROUND Patients ' ability to underst and information about medication is crucial for safety and effectiveness . Rates of illiteracy worldwide indicate that written information alone can not meet many patients ' needs . Medication pictograms are an alternative , but may be culturally sensitive . Previous testing has used large pictograms , which are impractical for conventional drug information formats . OBJECTIVE To compare 2 sets of pictograms for instructions or warnings ( from the US and South Africa ) for underst and ability by adults in the UK and examine the effects of pictogram size and repeat presentation on underst and ability among older adults . METHODS In the first part of the study , 160 adults ( aged 17–83 y ) review ed and interpreted 10 pictograms . In the second , 67 older adults ( aged 65–96 y ) were r and omly assigned to review 10 small or large pictograms . After giving their interpretation , they were informed of the correct meaning . One week later , they were shown the same pictograms and gave their interpretation . RESULTS The pictograms for the 10 different instructions and warnings showed great variation in interpretation rates ( 7.5–90 % ) , with few significant differences between the US and South African versions . Only 3 were understood by ≥85 % of the population . Pictograms performed significantly better if they were larger and at the second presentation . CONCLUSIONS Pictograms have the potential to help patients underst and information on drug therapy . This study shows that some existing pictograms are not easily interpreted and that testing is needed before their implementation . A reduction in their size to allow incorporation into conventional written formats may cause additional problems for patients Three thous and four hundred and ten patients recruited at 254 pharmacies took part in a national postal survey of the effect of prescription information leaflets . The patients had been prescribed penicillins , non-steroidal anti-inflammatory drugs ( NSAIDs ) or β-adrenoceptor antagonists . The 1809 patients who received leaflets knew more about their medicines , especially the side effects and were significantly more satisfied than the 1601 patients who were not given additional written information . The leaflets were found to be effective when issued in the north , in the south and in small , medium and large towns . Patients of both sexes , all age groups and social classes were found to benefit from the leaflets and almost everyone ( 97 % ) thought they were a good idea . These results confirm and extend our previous findings and add further support for the routine use of information leaflets with prescribed medicines One hundred and ninety-six patients over the age of 65 years suffering from joint pain were r and omised to receive one of three patient information leaflets describing a hypothetical pain medication , a st and ard textual patient information leaflet ( PIL ) given out by a pharmaceutical chain , and two alternate-forms depicting information with icons and graphs . The results showed that patients r and omised to the traditional PIL were less likely to consider taking the hypothetical medication OBJECTIVES To characterize the degree of disparity between physicians ' perceptions of older patients ' medication regimen and patients ' perceptions of their regimen . DESIGN Prospect i ve observational . Physicians and patients were blinded at index visit ; after , trained medical students made home visits , collecting information about medications that was compared with physician question naires . SETTING Community family medicine residency program . PARTICIPANTS Patients age 65 and older presenting for routine visit , taking at least four prescription medications , and seen by index physician three or more times in
Output:
| Findings showed that patients request information about a drug 's indication , expected benefits , duration of therapy , and a thorough list of potential adverse effects .
The evidence about label format supports the use of larger fonts , lists , headers , and white space , using simple language and logical organization to improve readability and comprehension .
Evidence was not sufficient to support the use of pictographic icons .
Little evidence linked label design or content to measurable health outcomes , adherence , or safety .
Conclusions : Evidence suggests that specific content and format of prescription drug labels facilitate communication with and comprehension by patients . |
MS213928 | ***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 compare nurse practitioner/physician management of hospital care , multidisciplinary team-based planning , expedited discharge , and assessment after discharge to usual management . Background : In the context of managed care , the goal of academic medical centers is to provide quality care at the lowest cost and minimize length of stay ( LOS ) while not compromising quality . Methods : Comparative , 2-group , quasiexperimental design was used ; 1,207 general medicine patients ( n = 581 in the experimental group and n = 626 in the control group ) were enrolled . The control unit provided usual care . The care management in the experimental unit had 3 different components : an advanced practice nurse who followed the patients during hospitalization and 30 days after discharge , a hospitalist medical director and another hospitalist , and daily multidisciplinary rounds . LOS , hospital costs , mortality , and readmission 4 months after discharge were measured . Results : Average LOS was significantly lower for patients in the experimental group than the control group ( 5 vs. 6 days , P < .0001 ) . The " backfill profit " to the hospital was US$ 1591 per patient in the experimental group ( SE , US$ 639 ) . There were no significant group differences in mortality or readmissions . Conclusions : Collaborative physician/nurse practitioner multidisciplinary care management of hospitalized medical patients reduced LOS and improved hospital profit without altering readmissions or mortality Objective . Hospitals adapt to changing market conditions by exploring new care models that allow them to maintain high quality while containing costs . The authors examined the net cost savings associated with care management by teams of physicians and nurse practitioners , along with daily multidisciplinary rounds and postdischarge patient follow-up . Methods . One thous and two hundred and seven general medicine in patients in an academic medical center were r and omized to the intervention versus usual care . Intervention costs were compared to the difference in nonintervention costs , estimated by comparing changes between preadmission and postadmission in regression-adjusted costs for intervention versus usual care patients . Intervention costs were calculated by assigning hourly costs to the time spent by different providers on the intervention . Patient costs during the index hospital stay were estimated from administrative records and during the 4-month follow-up by weighting selfreported utilization by unit costs . Results . Intervention costs were $ 1187 per patient and associated with a significant $ 3331 reduction in nonintervention costs . About $ 1947 of the savings were realized during the initial hospital stay , with the remainder attributable to reductions in postdischarge service use . After adjustment for possible attrition bias , a reasonable estimate of the cost offset was $ 2165 , for a net cost savings of $ 978 per patient . Because health outcomes were comparable for the 2 groups , the intervention was cost-effective . Conclusions . Wider adoption of multidisciplinary interventions in similar setting s might be considered . The savings previously reported with hospitalist models may also be achievable with other models that focus on efficient inpatient care and appropriate postdischarge care
Output:
| Nurse practitioners and medical practitioners have differing views on the essentials of collaboration and on supervision and autonomous nurse practitioner practice .
Medical practitioners who have a working experience with NPs express more positive attitudes towards collaboration .
Both professional groups report concerns and negative experiences with collaborative practice but also value certain advantages of collaboration .
Conclusions The review shows that working in collaboration is a slow progression .
Exposure to working together helps to overcome professional hurdles , dispel concerns and provide clarity around roles and the meaning of collaboration of NPs and MPs . |
MS213929 | ***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: PET using 18F-FDG has prognostic value when performed at the completion of initial chemotherapy in patients with diffuse large B-cell lymphoma ( DLBCL ) . 18F-FDG PET may also be predictive of outcome when performed during the treatment course of DLBCL , but robust prospect i ve studies and st and ardization of 18F-FDG PET interpretation in this setting are lacking . Methods : In this prospect i ve study , patients with advanced-stage DLBCL were treated with st and ard rituximab , cyclophosphamide , doxorubicin , vincristine , and prednisone chemotherapy , and 18F-FDG PET/CT was performed after cycle 2 or 3 and at the end of therapy . The 18F-FDG PET/CT scans were interpreted according to the International Harmonization Project for Response Criteria in Lymphoma , and the maximum st and ardized uptake value ( SUV ) of the most 18F-FDG – avid lesions was recorded . Results : Fifty patients were enrolled , and all underwent interim 18F-FDG PET/CT . At a median follow-up of 33.9 mo , the positive predictive value ( PPV ) of interim 18F-FDG PET/CT for relapse or progression was 42 % , and the negative predictive value ( NPV ) was 77 % . Interim 18F-FDG PET/CT was significantly associated with event-free survival ( P = 0.017 ) and with progression-free survival ( P = 0.04 ) but not with overall survival ( P = 0.08 ) . End-of-therapy 18F-FDG PET/CT had high PPV and NPV ( 71 % and 80 % , respectively ) and was significantly associated with event-free survival , progression-free survival , and overall survival ( P < 0.001 ) . SUV measurements did not discriminate patients who relapsed or progressed from those who remained in remission . Conclusion : When performed after 2 cycles of immunochemotherapy and interpreted according to International Harmonization Project criteria , early response assessment with PET/CT has a high NPV but low PPV in patients with advanced-stage DLBCL . Prospect i ve trials are required to vali date different criteria for the interpretation of interim 18F-FDG PET/CT and establish the role of interim 18F-FDG PET/CT in the management of patients with DLBCL The International Prognostic Index ( IPI ) is a widely accepted model that is used to predict the prognosis of patients with diffuse large B-cell lymphoma ( DLBCL ) who are treated using chemotherapy . However , the prognostic value of the IPI has been a focal point of debate in the immunochemotherapy era . The aim of this study was to reassess the value of the IPI and revised IPI ( R-IPI ) in a Chinese population . A multicentre retrospective analysis of DLBCL patients who were treated with cyclophosphamide , doxorubicin , vincristine and prednisone (CHOP)-like chemotherapy alone or chemotherapy plus rituximab ( R-CHOP-like ) was performed . The prognostic values of IPI and R-IPI at the time of diagnosis with respect to overall survival ( OS ) and progression-free survival ( PFS ) were evaluated . Among the 438 patients in the study , 241 received a CHOP-like regimen and 197 patients received an R-CHOP-like regimen . Although the IPI remained predictive for the CHOP-like group , it failed to distinguish between the various prognostic categories in the R-CHOP-like group . Notably , redistribution of the IPI factors into R-IPI factors identified three discrete prognostic groups with significantly different outcomes in both the CHOP-like and R-CHOP-like groups . In the R-CHOP-like group , these three risk groups , very good , good and poor , had distinctly different 3-year PFS rates of 96 , 84.3 and 67.5 % ( P=0.001 ) , and 3-year OS rates of 96 , 87.6 and 71.1 % ( P=0.003 ) , respectively . Our study demonstrates the power of the R-IPI as a simplified and more clinical ly relevant predictor of disease outcome than the st and ard IPI in DLBCL population s in the rituximab era . Therefore , the R-IPI merits further study in a larger population -based prospect i ve study The prognostic value of interim positron emission tomography ( PET ) interpreted according to visual criteria is a matter of debate in diffuse large B-cell lymphoma ( DLBCL ) . Maximal st and ardized uptake value reduction ( ΔSUVmax ) may better predict outcome . To compare the prognostic value of both methods , we analyzed PET done at baseline ( PET0 ) and after 2 ( PET2 ) and 4 ( PET4 ) cycles in 85 patients with high-risk DLBCL enrolled on a prospect i ve multicenter trial . All images were central ly review ed and interpreted visually according to the International Harmonization Project criteria and by computing ΔSUVmax between PET0 and PET2 ( ΔSUVmaxPET0 - 2 ) or PET4 ( ΔSUVmaxPET0 - 4 ) . Optimal cutoff to predict progression or death was 66 % for ΔSUVmaxPET0 - 2 and 70 % for ΔSUVmaxPET0 - 4 . Outcomes did not differ significantly whether PET2 and PET4 were visually positive or negative . Inversely , ΔSUVmaxPET0 - 2 analysis ( > 66 % vs ≤ 66 % ) identified patients with significantly different 2-year progression-free survival ( 77 % vs 57 % ; P = .0282 ) and overall survival ( 93 % vs 60 % ; P < .0001 ) . ΔSUVmaxPET0 - 4 analysis ( > 70 % vs ≤ 70 % ) seemed even more predictive for 2-year progression-free survival ( 83 vs 40 % ; P < .0001 ) and overall survival ( 94 % vs 50 % ; P < .0001 ) . ΔSUVmax analysis of sequential interim PET is feasible for high-risk DLBCL and better predicts outcome than visual analysis . The trial was registered at http:// clinical trials.gov as NCT00498043 BACKGROUND Revised response criteria for aggressive lymphomas have been proposed ( Cheson , J Clin Oncol , 2007 ) stressing the role of (18)fluorodeoxyglucose-positron emission tomography ( PET ) in posttreatment evaluation . The value of PET after four cycles compared with the International Workshop Criteria ( IWC ) remains to be established . PATIENTS AND METHODS In all , 103 patients with untreated diffuse large B-cell lymphoma were prospect ively enrolled to evaluate the prognostic impact of PET after two and four cycles . RESULTS Median age was 53 years ( 19 - 79 ) , 68 % male . The International Prognostic Index was low=22 % , low-intermediate=19 % , intermediate-high=33 % and high risk=26 % . Treatment consisted of cyclophosphamide , doxorubicin , vincristine , prednisone ( CHOP ) ( 30 % ) or dose-intensified CHOP ( 70 % ) , with rituximab ( 49 % ) or without ( 51 % ) . Ninety-nine patients were evaluated by PET and IWC at four cycles : 77 ( 78 % ) had a negative PET , while 22 ( 22 % ) remained positive . The 5-year event-free survival ( EFS ) was 36 % for patients with a positive PET versus 80 % with a negative examination , whatever the response [ complete response ( CR ) versus partial response ( PR ) ] according to IWC ( P<0.0001 ) . Positive PET patients had a 5-year EFS of 58 % if in CR/CR unconfirmed by IWC and 0 % if not ( P<0.0001 ) . The same observations could be made in patients treated with and without rituximab . CONCLUSION The integration of PET in treatment evaluation offers a powerful tool to predict outcome PURPOSE (18)F-fluoro-2-dexoy-D-glucose-positron emission tomography (FDG-PET)/computerised tomography ( CT ) has been used for staging and monitoring responses to treatment in patients with diffuse large B cell lymphoma ( DLBCL ) . The sequential interim PET/CT was prospect ively investigated to determine whether it provided additional prognostic information and could be a positive predictable value within patients with the same international prognostic index ( IPI ) after the use of rituximab in DLBCL . METHODS One hundred and sixty-one patients with newly diagnosed DLBCL were enroled ; the assessment of the PET/CT was performed at the time of diagnosis and mid-treatment of rituxibmab , cyclophosphamide , doxorubicin , vincristine and prednisolone ( R-CHOP ) . RESULTS Sixty-seven patients ( 41.6 % ) presented with advanced stage disease and 27 ( 16.8 % ) had bulky lesions . Forty-three patients ( 26.7 % ) continued to have positive metabolic uptakes with a significantly high relapse rate ( 62.8 % ) compared to the patients with a negative interim PET/CT ( 12.1 % ) ( P<0.01 ) . After a median follow-up of 30.8months , the positivity of interim PET/CT was found to be a prognostic factor for both overall survival ( OS ) and progression-free survival ( PFS ) , with a hazard ratio of 4.07 ( 2.62 - 6.32 ) and 5.46 ( 3.49 - 8.52 ) , respectively . In the low-risk IPI group , the 3-year OS and PFS rates were significantly different in the patients with positive ( 53.3 % and 52.5 % ) and negative ( 93.8 % and 88.3 % ) interim PET/CT , respectively ( P<0.01 ) . These significant prognostic differences of interim PET/CT responses were consistent with the results of the patients with high-risk IPI group ( P<0.01 ) . CONCLUSIONS Interim PET/CT scanning had a significant predictive value for disease progression and survival of DLBCL in post-rituximab treatment ; it might be the single most important determinant of clinical outcome in patients with the same IPI risk PURPOSE Our main objective was to prospect ively determine the prognostic value of [(18)F]fluorodeoxyglucose positron emission tomography/computed tomography ( PET/CT ) after two cycles of rituximab plus cyclophosphamide , doxorubicin , vincristine , and prednisone given every 14 days ( R-CHOP-14 ) under st and ardized treatment and PET evaluation criteria . PATIENTS AND METHODS Patients with any stage of diffuse large B-cell lymphoma were treated with six cycles of R-CHOP-14 followed by two cycles of rituximab . PET/CT examinations were performed at baseline , after two cycles ( and after four cycles if the patient was PET-positive after two cycles ) , and at the end of treatment . PET/CT examinations were evaluated locally and by central review . The primary end point was event-free survival at 2 years ( 2-year EFS ) . RESULTS Median age of the 138 evaluable patients was 58.5 years with a WHO performance status of 0 , 1 , or 2 in 56 % , 36 % , or 8 % of the patients , respectively . By local assessment , 83 PET/CT scans ( 60 % ) were reported as positive and 55 ( 40 % ) as negative after two cycles of R-CHOP-14 . Two-year EFS was significantly shorter for PET-positive compared with PET-negative patients ( 48 % v 74 % ; P = .004 ) . Overall survival at 2 years was not significantly different , with 88 % for PET-positive versus 91 % for PET-negative patients ( P = .46 ) . By using central review and the Deauville criteria , 2-year EFS was 41 % versus 76 % ( P < .001 ) for patients who had interim PET/CT scans after two cycles of R-CHOP-14 and 24 % versus 72 % ( P < .001 ) for patients who had PET/CT scans at the end of treatment . CONCLUSION Our results confirmed that an interim PET/CT scan has limited prognostic value in patients with diffuse large B-cell lymphoma homogeneously treated with six cycles of R-CHOP-14 in a large prospect i ve trial . At this point , interim PET/CT scanning is not ready for clinical use to guide treatment decisions in individual patients Positron emission tomography ( PET ) has been found useful in monitoring response to treatment of malignant lymphoma . We investigated the ability of interim PET to monitor response to st and ard dose R-CHOP chemotherapy in chemotherapy-naïve patients with diffuse large B-cell lymphoma ( DLBCL ) . Between March 2004 and April 2009 , 155 DLBCL patients treated with R-CHOP and available for interim and post-treatment PET/CT were identified and included in this analysis . Response ,
Output:
| In subgroup analysis , IHP , Deauville criteria , and having no st and ard interpretation groups were factors able to predict PFS ; IHP and having no st and ard interpretation group were able to predict OS .
No significant difference in OS was observed when patients received 3 or fewer cycles of chemotherapy before PET/CT , though OS was significantly lower in patients receiving more than 3 chemotherapy cycles .
Conclusion IHP and Deauville criteria are commonly used for PET/CT visual evaluation at present .
Interim PET/CT analysis after 3 - 4 chemotherapy cycles is capable of predicting disease prognosis . |
MS213930 | ***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 the present study was to compare the effect of transcutaneous electric nerve stimulation ( TENS ) with the flat occlusal splint in the treatment of temporom and ibular joint ( TMJ ) disk displacement without reduction . Thirty-one patients were included and r and omly selected to be treated 6 weeks with either TENS ( 90 Hz , 30 min , three times/day ) or with a flat occlusal splint ( 24 h/day . Those selected for the TENS group had one electrode placed over the painful TMJ and another electrode over the anterior temporal muscle . The splint group used a conventional flat occlusal splint with cuspid guidance . Both treatment groups visited the clinic once a week . Symptoms and signs were registered before and after treatment . The intensity of pain was recorded with a visual analogue scale ( VAS ) and with an electronic pocket-sized recorder ( Pain-Track ) carried 1 week before and also the last week of treatment for continuous registration of pain . Measured with the VAS , half of the patients treated with splints became pain-free or their TMJ pain improved at least 50 % both at rest and with jaw function compared with only 6 % in the TENS-treated group . With regard to strictly chewing pain , the VAS-registered pain improved in two-thirds of the splint group , compared with 50 % of the TENS group . With the Pain-Track device it was found that in most individuals pain was aggrevated at mealtimes . The conclusion was that flat occlusal splints in several respects are better than TENS in the treatment of symptoms associated with TMJ disk displacement without reduction & NA ; The placebo effect of transcutaneous electrical stimulation was studied in 93 patients in a double‐blind cross‐over trial using a genuine stimulator and a placebo machine . Placebo analgesic effects occurred in 32 % of trials , as compared with 48 % for actual stimulation . The placebo effect of the transcutaneous electrical stimulator is similar to the placebo effect that is noted in other double‐blind studies in which medicationms are used & NA ; The effects of transcutaneous electrical nerve stimulation ( TENS ) on myofascial pain and trigger point sensitivity were assessed . Four modes of TENS and a no‐stimulation control were compared in a double‐blind design . Stimulation , carried out for 10 min on 60 subjects ( 12/group ) , showed significant pain reductions with 100 Hz , 250 msec stimulation followed by 100 Hz , 50 msec and then pain suppressor TENS . No pain reductions were found in the 2 Hz , 250 msec TENS or the control . No significant alteration in myofascial trigger point sensitivity , assessed with the pressure algometer , was found between the groups . The results suggest that high frequency , high intensity TENS is effective in reducing myofascial pain , and that these pain reductions do not reflect changes in local trigger point sensitivity 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 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 Our purpose was to compare the effects of high-intensity transcutaneous electrical nerve stimulation and oral naproxen ( 500 mg ) on intrauterine pressure and menstrual pain . STUDY DESIGN An open , r and omized crossover study was performed on 12 women with primary dysmenorrhea . Intrauterine pressure was recorded with a microtransducer catheter , and the pain score was assessed by a visual analog scale . RESULTS Before treatment all patients displayed signs of uterine hyperactivity as judged by a high resting pressure ( 7.5 + /- 0.4 kPa ) , high active pressure ( 24.0 + /- 0.8 kPa ) , and a high frequency of pressure cycles ( 13.3 + /- 0.5 contractions per 0.5 hour ) . Oral administration of naproxen suppressed ( p < 0.01 ) all uterine activity parameters . Treatment with transcutaneous electrical nerve stimulation induced a prompt onset of pain relief in a strictly segmental manner , but there were no significant changes in uterine activity . The pain score was significantly reduced ( p < 0.001 ) from 30 to 60 minutes after treatment with transcutaneous electrical nerve stimulation and from 19 to 120 minutes after naproxen administration . CONCLUSIONS Treatment with transcutaneous electrical nerve stimulation induced a prompt onset of pain relief without any significant changes in uterine activity . Possible mechanisms for the pain relief , decreased uterine ischemia or decreased activity in the pain transmission system at spinal or supraspinal levels , are discussed The purpose of this investigation was to evaluate the long-term course of non-invasively treated chronic headache . A total of 1015 adult patients with primary diagnosis of vascular/migraine or muscle contraction headache participated in the study investigating symptom frequency and severity over a 36 month period after receiving treatment . Treatment consisted of either : relaxation training ( stepwise relaxation/hypnosis/autogenic training/cognitive behavior therapy ) ; biofeedback ( thermal/photoplethysmograph/EMG ) ; micro-electrical therapy ( TENS/Neurotransmitter Modulation ) or multimodal treatment ( combination of any of the above two treatments ) . Seven hundred and ninety-three patients returned sufficient data to be included in the analysis . Patients were r and omly assigned to treatment groups and received either short term intervention ( 15 or less treatments ) or long term intervention ( greater than 15 treatments ) . Results indicate that all treatment conditions significantly reduced frequency and intensity of cephalalgia . Repeated measure analysis of variance indicated that grouping variables of Biofeedback treatment , symptoms being evidence d less than 2 years and receiving over 15 treatment sessions best predicted successful intervention The analgesic efficacy of various pulse patterns of transcutaneous electrical nerve stimulation ( TENS ) were assessed in 84 normal healthy subjects using the cold pressor pain technique . Burst , modulation , r and om and continuous TENS all significantly elevated ice pain threshold . Continuous ( 80 Hz ) TENS produced the greatest mean elevation in threshold but the response to r and om TENS showed the least inter-subject variation . Ice pain tolerance was increased by all modes of TENS , continuous TENS producing the greatest magnitude of response , although these changes did not reach statistical significance . Increasing the size of electrodes reduced the effect of continuous TENS . The clinical implication s of these findings are discussed Acupuncture is one of the oldest healing methods which is used in traditional medicine . In the modern medicine , we are witnessing a renaissance of this ancient treatment applied mainly in the management of chronic pain . A number of modern technological changes are being applied to replace , or modify , the classical needle treatment . Among many modalities used today is the novel addition in Transcutaneous Electrical Nerve Stimulation ( TENS ) called CODETRON which delivers acupuncture-like stimulation in a r and om order . CODETRON was developed by a Canadian Scientist and had been evaluated in a clinical trial in a multidisciplinary pain clinic on patients who came for acupuncture therapy over a period of two years . Indications , effectiveness and experiences with this form of treatment are presented . In addition , results obtained from a six week double-blind r and omized placebo controlled pilot trial of osteoarthritis of the hip/knee with CODETRON which was conducted later . The results were highly suggestive of the beneficial effect of this nonhabituating mode of therapy and confirmed our initial uncontrolled trial results There is currently no established treatment for intermittent claudication with proven long term benefit . Exercise classes have been shown to improve walking distance . Chronic electromyostimulation ( CEMS ) a method of stimulating skeletal muscle has effects on normal muscle which may also benefit claudicants . We investigated the effects of one month of CEMS on claudicants in a single blind placebo controlled study . Patients were r and omised to either CEMS ( treatment ) or transcutaneous nerve stimulation ( TENS ) placebo . The effects of the two modalities were assessed using the conventional measures of claudicating distance ( CD ) , maximum walking distance ( MWD ) , ankle-brachial pressure index ( ABPI ) and pressure recovery time ( PRT ) . Muscle performance was assessed by the fatigue index ( FI ) a technique determining the decrease in ischaemic muscle response to repeated contraction . After 4 weeks treatment the CEMS group showed significant improvements in their median CD ( 88 to 111 ) and MWD ( 118 to 158 ) ; this was not seen in the control group . Muscle performance also increased significantly during the 4 weeks of treatment in the CEMS group but not in the control group . These changes were not maintained after CEMS was stopped . This pilot study suggests that CEMS may well have a role to play in the treatment of intermittent claudication though a number of further studies need to be undertaken Abstract . in this study we describe the use of high‐frequency transcutaneous electrical nerve stimulation ( TENS ) ( 100 Hz ) and low‐frequency TENS ( lf‐TENS ) ( 2 Hz trains ) as compared with placebo‐TENS ( p‐TENS ) in a group of 21 patients suffering from primary dysmenorrhea . Naloxone , a relatively pure opiate antagonist , was an additional test administered to 6 volunteer patients who had experienced an alleviation of pain with TENS . As will be seen , 14 out of 21 patients receiving high‐frequency TENS ( hf‐TENS ) experienced a pain reduction exceeding 50 % of its original intensity . During lf‐TENS or p‐TENS , only 7 and 5 patients , respectively , obtained pain relief exceeding 50 % . in 4 out of 6 volunteer patients , the relief of pain obtained with lf‐TENS was counteracted by naloxone , whereas the relief experienced with hf‐TENS in the same patients was , in general , unaffected by naloxone We compared the effects of four treatment variables on the pain reduction produced by transcutaneous electrical nerve stimulation and attempted to establish indications for TENS based on patient history and pain evaluation items . Treatment variables were the therapist and the three TENS stimulus characteristics -- pulse width , frequency , and amplitude . We r and omly assigned 192 consecutive adult patients suffering from painful conditions to one of four physical therapists and one of 12 stimulus characteristic combinations . We used a st and ar
Output:
| REVIEW ER 'S CONCLUSIONS The results of this review are inconclusive ; the published trials do not provide information on the stimulation parameters which are most likely to provide optimum pain relief , nor do they answer questions about long-term effectiveness . |
MS213931 | ***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 the process variables involved in a weight loss program for African-American adolescent girls . Several process variables have been identified as affecting success in in vivo weight loss programs for adults and children , including program adherence , self-efficacy , and social support . The current study sought to broaden the underst and ing of these process variables as they pertain to an intervention program that is presented using the Internet . It was hypothesized that variables such as program adherence , dietary self-efficacy , psychological factors , and family environment factors would mediate the effect of the experimental condition on weight loss . RESEARCH METHODS AND PROCEDURES Participants were 57 adolescent African-American girls who joined the program with one obese parent ; family pairs were r and omized to either a behavioral or control condition in an Internet-based weight loss program . Outcome data ( weight loss ) are reported for the first 6 months of the intervention . RESULTS Results partially supported the hypotheses . For weight loss among adolescents , parent variables pertaining to life and family satisfaction were the strongest mediating variables . For parental weight loss , changes in dietary practice s over the course of 6 months were the strongest mediators . DISCUSSION The identification of factors that enhance or impede weight loss for adolescents is an important step in improving weight loss programs for this group . The current findings suggest that family/parental variables exert a strong influence on weight loss efforts for adolescents and should be considered in developing future programs OBJECTIVE To test the feasibility , acceptability , and potential efficacy of after-school dance classes and a family-based intervention to reduce television viewing , thereby reducing weight gain , among African-American girls . DESIGN Twelve-week , 2-arm parallel group , r and omized controlled trial . SETTING Low-income neighborhoods . PARTICIPANTS Sixty-one 8 - 10-year-old African-American girls and their parents/guardians . INTERVENTIONS The treatment intervention consisted of after-school dance classes at 3 community centers , and a 5-lesson intervention , delivered in participants ' homes , and design ed to reduce television , videotape , and video game use . The active control intervention consisted of disseminating newsletters and delivering health education lectures . MAIN OUTCOME MEASURES Implementation and process measures , body mass index , waist circumference , physical activity measured by accelerometry , self-reported media use , and meals eaten with TV . RESULTS Recruitment and retention goals were exceeded . High rates of participation were achieved for assessment s and intervention activities , except where transportation was lacking . All interventions received high satisfaction ratings . At follow up , girls in the treatment group , as compared to the control group , exhibited trends toward lower body mass index ( adjusted difference = -.32 kg/m2 , 95 % confidence interval [ CI ] -.77 , .12 ; Cohen 's d = .38 st and ard deviation units ) and waist circumference ( adjusted difference = -.63 cm , 95 % CI -1.92 , .67 ; d = .25 ) ; increased after-school physical activity ( adjusted difference = 55.1 counts/minute , 95 % CI -115.6 , 225.8 ; d = .21 ) ; and reduced television , videotape , and video game use ( adjusted difference = -4.96 hours/week , 95 % CI -11.41 , 1.49 ; d = .40 ) . The treatment group reported significantly reduced household television viewing ( d = .73 , P = .007 ) and fewer dinners eaten while watching TV ( adjusted difference = -1.60 meals/week , 95 % CI -2.99 , -.21 ; d = .59 ; P = .03 ) . Treatment group girls also reported less concern about weight ( d = .60 ; P = .03 ) , and a trend toward improved school grade s ( d = .51 ; P = .07 ) . CONCLUSIONS This study confirmed the feasibility , acceptability , and potential efficacy of using dance classes and a family-based intervention to reduce television viewing , thereby reducing weight gain , in African-American girls BACKGROUND The prevalence of obesity in the United States is a significant public health problem . Many obesity-related risk factors are more prevalent in minority population s. Given the recalcitrant nature of weight loss interventions for adults , prevention of overweight and obesity has become a high priority . The present study reports baseline data from an obesity prevention intervention developed for minority preschool children . METHODS Hip-Hop to Health Jr. is a 5-year r and omized controlled intervention that targets 3- to 5-year-old minority children enrolled in 24 Head Start programs . Our primary aim is to test the effect of the intervention on change in body mass index . Data were collected on sociodemographic , anthropometric , behavioral , and cognitive variables for the children and parents at baseline . RESULTS Participants included 416 black children , 337 black parents , 362 Latino children , and 309 Latino parents . Using body mass index for age and sex > or = the 95th percentile as the definition of overweight , 15 % of the black children and 28 % of the Latino children were overweight . More than 75 % of the parents were either overweight or obese . DISCUSSION The development of interventions to effectively prevent or control obesity early in life is crucial . These data highlight the escalating problem of weight control in minority population BACKGROUND Effective clinical weight management approaches are needed to reach African-Americans . METHODS African-Americans recruited through outpatient practice s for a culturally-adapted Healthy Eating and Lifestyle Program were offered 10 weekly weight loss classes ( Phase 1 ) with the option of continuing for another 8 - 18 months ( Phase 2 ) in a r and omized comparison of further group counseling or staff-facilitated self-help vs. follow-up clinic visits only . RESULTS Of 237 enrollees ( 91 % women ; mean age 43.5 years ; mean body mass index 38.0 kg/m(2 ) ) , 70 [ corrected ] attended no classes or only the first Phase 1 class , 134 provided Phase 1 follow-up data , 128 were r and omized in Phase 2 , and 87 provided final follow-up data ( " completers " ) . Mean weight changes for completers were : -1.5 ( P < 0.001 ) , + 0.3 ( P = 0.47 ) , and -1.2 ( P = 0.04 ) kg , respectively , for Phase 1 , Phase 2 , and overall ( baseline to final visit ; average 18 months total duration ) , with no Phase 2 treatment effect ( P = 0.55 ) . Final study weight was > or = 5 % below baseline for 25 % of completers and was strongly predicted by Phase 1 weight loss . CONCLUSIONS Weight loss achieved in Phase 1 was maintained even with relatively minimal follow-up contact . Increasing the percent who achieve clinical ly significant weight loss initially would improve long-term results BACKGROUND Type 2 diabetes is up to four times more common in British Asians , but they know little about its management and complications . AIM To design and evaluate a structured pictorial teaching programme for Pakistani Moslem patients in Manchester with type 2 diabetes . METHOD A r and omized controlled trial of pictorial flashcard one-to-one education in 201 patients attending a hospital outpatient clinic or diabetic clinics in ten general practice s in Manchester . Patients ' knowledge , self-caring skills and attitudes to diabetes were measured on four topics before the structured teaching , and compared with results six months later . RESULTS All parameters of knowledge were increased in the study group ; for example , percentage scores for correctly identifying different food values increased from 57 % to 71 % ( Analysis of Variance ( ANOVA ) adjusted difference + 11.8 % ) and knowledge of one diabetic complication from 18 % to 78 % . Self-caring behaviour improved , with 92 % of patients doing regular glucose tests at six months compared with 63 % at the start . Attitudinal views were more resistant to change , with patients still finding it hard to choose suitable foods at social occasions . Haemoglobin A1c control improved by 0.34 % over six months ( ANOVA adjusted difference , 95 % CI -0.8 % to + 0.1 % ) . CONCLUSION It is concluded that this health education programme can empower Asian diabetics to take control of their diets , learn to monitor and interpret glucose results , and underst and the implication s of poor glycaemic control for diabetic complications OBJECTIVE This study tested the efficacy of an 8-week culturally targeted nutrition and physical activity intervention on body composition . METHODS A r and omized , attention-controlled , two-group trial was conducted in a blackowned commercial gym with a sample of 366 predominantly healthy , obese African American women . A free 1-year membership to the study site gym was provided to participants in both groups . Data were collected at baseline , 2 , 6 , and 12 months . RESULTS Sample retention at 1 year was 71 % . Between-group longitudinal analysis including only participants with complete data revealed a trend toward weight stability in the intervention group at 2 months compared with controls ( + 0.05 kg/m(2 ) , p = 0.75 ; + 0.32 kg/m(2 ) , p = 0.08 , respectively ) , disappearing at 12 months ( + 1.37 kg/m(2 ) , p = 0.0001 ; + 1.02 kg/m(2 ) , p = 0.001 , respectively ) . Within-group analysis demonstrated that intervention and control participants ' fitness ( 1-mile run-walk ) improved by 1.9 minutes ( p = 0.0001 ) and 2.3 minutes ( p = 0.0001 ) , respectively , at 12 months . Mixed model regression analyses demonstrated a significant main effect of the intervention on fitness ( p = 0.0185 ) and a marginally significant effect on body mass index ( BMI ) ( p = 0.057 ) , at 2 months , disappearing by 6 months . By 12 months , however , the controls exhibited a significant advantage in waist circumference stability compared with intervention participants ( + 1.1 cm , p = 0.2763 ; + 2.1 cm , p = 0.0002 , respectively ) . CONCLUSIONS The intervention produced modest short-term improvements in body composition , but the economic incentive of a free 1-year gym membership provided to all participants was a more potent intervention than the education and social support intervention tested . However , longer-term fitness enhancement remains elusive and dem and s research and policy attention . These findings have policy implication s in that employer-/insurer-subsidized gym memberships may require interventions targeting other levels of change ( e.g. , physical or social/environmental ) to foster sustainable fitness improvements A continuing challenge in weight loss treatment is attaining maintenance of weight loss . The goal of this study was to develop a counseling method that would assist African American breast cancer survivors with weight loss maintenance . In this pilot study , 31 obese breast cancer survivors were recruited . Individualized , dietitian-led counseling by telephone and free Weight Watchers coupons were provided to all participants for 18 months . At the 6-month time point , women were r and omized to receive spirituality counseling or not in addition to the st and ard program . The spirituality counseling was delivered via telephone using an 8-step framework . Subjects were asked to utilize daily meditation or prayer , daily readings , and the recording of thoughts in a journal . Mean weight loss from baseline to 6 months was a modest 2.0 % of baseline weight . From 6 to 18 months , there was no further weight change in the spirituality arm and a gain of 0.7 % in the dietitian-only arm . Despite little effect on weight loss , it did appear that spirituality counseling positively affected spiritual well-being ( FACIT-Sp ) scores and dietary quality . The spirituality counseling framework therefore may be further refined and useful for other health promotion studies with African American population Abstract Compared to other racial/ethnic groups , African American ( AA ) women are more likely to be obese but less likely to participate in weight loss interventions or to successfully lose weight . Sustained motivation for weight loss may be especially difficult for AA women due to socioeconomic and cultural factors . The purpose of this study was to examine whether the addition of motivational interviewing ( MI ) to a culturally-targeted behavioral weight loss program for AA women improved adherence to the program , diet and physical activity behaviors , and weight loss outcomes . Forty-four obese ( mean BMI = 39.4 , SD = 7.1 ) AA women were r and omized to receive a 16-week behavioral weight loss program plus four MI sessions , or the same behavioral weight loss program plus four health education ( HE ; attention control ) sessions . Results showed that participants in both MI and HE conditions lost a significant amount of weight , reduced their energy intake and percent calories from fat , and increased their fruit and vegetable consumption ( ps < .05 ) . However , adherence to the behavioral weight loss program and changes in diet , physical activity , and weight did not differ across MI and HE conditions . Future research is warranted to determine the sub population s with which MI is most effective BACKGROUND This article provides a descriptive overview of the implementation process of the Heart , Body , and Soul program . The program objective was to test strategies to reduce the prevalence of cigarette smoking among urban African Americans in East Baltimore . METHOD This study constitutes a prospect i ve r and omized trial among inner-city African Americans design ed to improve quit rates among church attenders . A r and om-digit-dialing survey was conducted to establish baseline levels of self-reported cigarette smoking , examine attendant
Output:
| The most consistent evidence of effectiveness was for pharmacological interventions for smoking cessation .
This body of work , however , provided scant evidence on the effectiveness of these interventions for ethnic minority groups .
Lastly , given our focus on three health areas and three population s , we have inevitably excluded many studies of adapted interventions for other health topics and other ethnic minority population s. CONCLUSIONS There is currently a lack of evidence on how best to deliver smoking cessation , physical activity and healthy eating-related health promotion interventions to ethnic minority population s. Although culturally adapting interventions can increase salience , acceptability and uptake , there is as yet insufficient evidence on the clinical effectiveness or cost-effectiveness of these adapted approaches . |
MS213932 | ***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 associations of metformin , serum vitamin B12 , calcium supplements , and cognitive impairment in patients with diabetes . RESEARCH DESIGN AND METHODS Participants were recruited from the Primary Research in Memory ( PRIME ) clinics study , the Australian Imaging , Biomarkers and Lifestyle ( AIBL ) study of aging , and the Barwon region of southeastern Australia . Patients with Alzheimer disease ( AD ) ( n = 480 ) or mild cognitive impairment ( n = 187 ) and those who were cognitively intact ( n = 687 ) were included ; patients with stroke or with neurodegenerative diseases other than AD were excluded . Subgroup analyses were performed for participants who had either type 2 diabetes ( n = 104 ) or impaired glucose tolerance ( n = 22 ) . RESULTS Participants with diabetes ( n = 126 ) had worse cognitive performance than participants who did not have diabetes ( n = 1,228 ; adjusted odds ratio 1.51 [ 95 % CI 1.03–2.21 ] ) . Among participants with diabetes , worse cognitive performance was associated with metformin use ( 2.23 [ 1.05–4.75 ] ) . After adjusting for age , sex , level of education , history of depression , serum vitamin B12 , and metformin use , participants with diabetes who were taking calcium supplements had better cognitive performance ( 0.41 [ 0.19–0.92 ] ) . CONCLUSIONS Metformin use was associated with impaired cognitive performance . Vitamin B12 and calcium supplements may alleviate metformin-induced vitamin B12 deficiency and were associated with better cognitive outcomes . Prospect i ve trials are warranted to assess the beneficial effects of vitamin B12 and calcium use on cognition in older people with diabetes who are taking metformin Epidemiological studies have identified a robust association between type II diabetes mellitus and Alzheimer disease ( AD ) , and neurobiological studies have suggested the presence of central nervous system insulin resistance in individuals with AD . Given this association , we hypothesized that the central nervous system – penetrant insulin-sensitizing medication metformin would be beneficial as a disease-modifying and /or symptomatic therapy for AD , and conducted a placebo-controlled crossover study of its effects on cerebrospinal fluid ( CSF ) , neuroimaging , and cognitive biomarkers . Twenty nondiabetic subjects with mild cognitive impairment or mild dementia due to AD were r and omized to receive metformin then placebo for 8 weeks each or vice versa . CSF and neuroimaging ( Arterial Spin Label MRI ) data were collected for biomarker analyses , and cognitive testing was performed . Metformin was found to be safe , well-tolerated , and measureable in CSF at an average steady-state concentration of 95.6 ng/mL. Metformin was associated with improved executive functioning , and trends suggested improvement in learning/memory and attention . No significant changes in cerebral blood flow were observed , though post hoc completer analyses suggested an increase in orbitofrontal cerebral blood flow with metformin exposure . Further study of these findings is warranted INTRODUCTION Type 2 diabetes ( DM-2 ) increases the risk of developing Alzheimer´s disease ( AD ) , and patients with AD are more likely to develop DM-2 . DM-2 and AD share some pathophysiological features . In AD , amyloid-β ( Aβ ) is accumulated as extracellular plaques in the gray matter of the brain , while in DM-2 islet amyloid polypeptide ( IAPP ) is accumulated in the pancreas . Premature cellular degeneration is seen in both diseases . Glucagon-like peptide-1 ( GLP-1 ) reduces the amount of Aβ and improves cognition in animal studies . The present study tests the hypothesis that treatment with the long-acting GLP-1 receptor agonist liraglutide affects the accumulation of Aβ in patients with AD . MATERIAL AND METHODS This is a r and omized , controlled , double-blinded intervention study with AD patients treated for six months with liraglutide ( n = 20 ) or placebo ( n = 20 ) . The primary outcome is change in deposition of Aβ in the central nervous system ( CNS ) by Pittsburgh compound B positron emission tomography ( PET ) . The secondary outcome is evaluation of cognition using a neuro-psychological test battery , and examination of changes in glucose uptake in the CNS by 18F-fluoro-deoxy-glucose PET . Finally , a perfusion-weighted magnetic resonance imaging with contrast will be performed to evaluate blood flow . CONCLUSION No registered drug affects the deposition of Aβ in the brain of AD patients . Our goal is to find a new therapeutic agent that alters the pathophysiology in AD patients by decreasing the formation of Aβ plaques and thereby presumably improves the cognitive function . FUNDING The trial is investigator-initiated and investigator-driven and is supported by Novo Nordisk Sc and inavia . TRIAL REGISTRATION Clinical Trials.gov : NCT01469351 OBJECTIVE To examine the effects of intranasal insulin administration on cognition , function , cerebral glucose metabolism , and cerebrospinal fluid biomarkers in adults with amnestic mild cognitive impairment or Alzheimer disease ( AD ) . DESIGN R and omized , double-blind , placebo-controlled trial . SETTING Clinical research unit of a Veterans Affairs medical center . PARTICIPANTS The intent-to-treat sample consisted of 104 adults with amnestic mild cognitive impairment ( n = 64 ) or mild to moderate AD ( n = 40 ) . Intervention Participants received placebo ( n = 30 ) , 20 IU of insulin ( n = 36 ) , or 40 IU of insulin ( n = 38 ) for 4 months , administered with a nasal drug delivery device ( Kurve Technology , Bothell , Washington ) . MAIN OUTCOME MEASURES Primary measures consisted of delayed story recall score and the Dementia Severity Rating Scale score , and secondary measures included the Alzheimer Disease 's Assessment Scale-cognitive subscale ( ADAS-cog ) score and the Alzheimer 's Disease Cooperative Study -activities of daily living ( ADCS-ADL ) scale . A subset of participants underwent lumbar puncture ( n = 23 ) and positron emission tomography with fludeoxyglucose F 18 ( n = 40 ) before and after treatment . RESULTS Outcome measures were analyzed using repeated- measures analysis of covariance . Treatment with 20 IU of insulin improved delayed memory ( P < .05 ) , and both doses of insulin ( 20 and 40 IU ) preserved caregiver-rated functional ability ( P < .01 ) . Both insulin doses also preserved general cognition as assessed by the ADAS-cog score for younger participants and functional abilities as assessed by the ADCS-ADL scale for adults with AD ( P < .05 ) . Cerebrospinal fluid biomarkers did not change for insulin-treated participants as a group , but , in exploratory analyses , changes in memory and function were associated with changes in the Aβ42 level and in the tau protein-to-Aβ42 ratio in cerebrospinal fluid . Placebo-assigned participants showed decreased fludeoxyglucose F 18 uptake in the parietotemporal , frontal , precuneus , and cuneus regions and insulin-minimized progression . No treatment-related severe adverse events occurred . CONCLUSIONS These results support longer trials of intranasal insulin therapy for patients with amnestic mild cognitive impairment and patients with AD . Trial Registration clinical trials.gov Identifier : NCT00438568
Output:
| The results of 29 pairwise comparisons indicated that cognition was significantly improved in subjects treated with antidiabetic agents compared with placebo .
Pioglitazone 15 to 30 mg demonstrated the greatest efficacy compared to placebo in network meta- analysis .
No significant differences in acceptability were identified when comparing agents with each other and with placebo .
The current findings indicate a pro-cognitive class effect of antidiabetic agents in AD/MCI . |
MS213933 | ***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 .To provide a practical quantitative tool for appraising the quality of cost-effectiveness ( CE ) studies . Methods .A committee comprised of health economists selected a set of criteria for the instrument from an item pool . Data collected with a conjoint analysis survey on 120 international health economists were used to estimate weights for each criterion with a r and om effects regression model . To vali date the grading system , a survey was sent to 60 individuals with health economics expertise . Participants first rated the quality of three CE studies on a visual analogue scale , and then evaluated each study using the grading system . Spearman rho and Wilcoxon tests were used to detect convergent validity and analysis of covariance ( ANCOVA ) for discriminant validity . Agreement between the global rating by experts and the grading system was also examined . Results .Sixteen criteria were selected . Their coefficient estimates ranged from 1.2 to 8.9 , with a sum of 93.5 on a 100-point scale . The only insignificant criterion was “ use of subgroup analyses . ” Both convergent validity and discriminant validity of the grading system were shown by the results of the Spearman rho ( correlation coefficient = 0.78 , P < 0.0001 ) , Wilcoxon test ( P = 0.53 ) , and ANCOVA ( F3,146 = 5.97 , P = 0.001 ) . The grading system had good agreement with global rating by experts . Conclusions . The instrument appears to be simple , internally consistent , and valid for measuring the perceived quality of CE studies . Applicability for use in clinical and re source allocation decision-making deserves further study UNLABELLED In February 2010 , the Medical Advisory Secretariat ( MAS ) began work on evidence -based review s of the literature surrounding three pharmacogenomic tests . This project came about when Cancer Care Ontario ( CCO ) asked MAS to provide evidence -based analyses on the effectiveness and cost-effectiveness of three oncology pharmacogenomic tests currently in use in Ontario . Evidence -based analyses have been prepared for each of these technologies . These have been completed in conjunction with internal and external stakeholders , including a Provincial Expert Panel on Pharmacogenomics ( PEPP ) . Within the PEPP , subgroup committees were developed for each disease area . For each technology , an economic analysis was also completed by the Toronto Health Economics and Technology Assessment Collaborative ( THETA ) and is summarized within the reports . THE FOLLOWING REPORTS CAN BE PUBLICLY ACCESSED AT THE MAS WEBSITE AT : www.health.gov.on.ca/mas or at www.health.gov.on.ca/english/providers/program/mas/mas_about.htmlGENE EXPRESSION PROFILING FOR GUIDING ADJUVANT CHEMOTHERAPY DECISIONS IN WOMEN WITH EARLY BREAST CANCER : An Evidence -Based and Economic Analysis Epidermal Growth Factor Receptor Mutation ( EGFR ) Testing for Prediction of Response to EGFR-Targeting Tyrosine Kinase Inhibitor ( TKI ) Drugs in Patients with Advanced Non-Small-Cell Lung Cancer : an Evidence -Based and Economic Analysis K-RAS testing in Treatment Decisions for Advanced Colorectal Cancer : an Evidence -Based and Economic Analysis . OBJECTIVE The objective of this systematic review is to determine the predictive value of KRAS testing in the treatment of metastatic colorectal cancer ( mCRC ) with two anti-EGFR agents , cetuximab and panitumumab . Economic analyses are also being conducted to evaluate the cost-effectiveness of KRAS testing . CLINICAL NEED CONDITION AND TARGET POPULATION Metastatic colorectal cancer ( mCRC ) is usually defined as stage IV disease according to the American Joint Committee on Cancer tumour node metastasis ( TNM ) system or stage D in the Duke 's classification system . Patients with advanced colorectal cancer ( mCRC ) either present with metastatic disease or develop it through disease progression . KRAS ( Kristen-RAS , a member of the rat sarcoma virus ( ras ) gene family of oncogenes ) is frequently mutated in epithelial cancers such as colorectal cancer , with mutations occurring in mutational hotspots ( codons 12 and 13 ) of the KRAS protein . Involved in EGFR-mediated signalling of cellular processes such as cell proliferation , resistance to apoptosis , enhanced cell motility and neoangiogenesis , a mutation in the KRAS gene is believed to be involved in cancer pathogenesis . Such a mutation is also hypothesized to be involved in resistance to targeted anti-EGFR ( epidermal growth factor receptor with tyrosine kinase activity ) treatments such as cetuximab and panitumumab , hence , the important in evaluating the evidence on the predictive value of KRAS testing in this context . KRAS MUTATION TESTING IN ADVANCED COLORECTAL CANCER : Both cetuximab and panitumumab are indicated by Health Canada in the treatment of patients with metastatic colorectal cancer whose tumours are WT for the KRAS gene . Cetuximab may be offered as monotherapy in patients intolerant to irinotecan-based chemotherapy or in patients who have failed both irinotecan and oxaliplatin-based regimens and who received a fluoropyrimidine . It can also be administered in combination with irinotecan in patients refractory to other irinotecan-based chemotherapy regimens . Panitumumab is only indicated as a single agent after failure of fluoropyrimidine- , oxaliplatin- , and irinotecan-containing chemotherapy regimens . In Ontario , patients with advanced colorectal cancer who are refractory to chemotherapy may be offered the targeted anti-EGFR treatments cetuximab or panitumumab . Eligibility for these treatments is based on the KRAS status of their tumour , derived from tissue collected from surgical or biopsy specimens . It is believed that KRAS status is not affected by treatments , therefore , for patients for whom surgical tissue is available for KRAS testing , additional biopsies prior to treatment with these targeted agents is not necessary . For patients that have not undergone surgery or for whom surgical tissue is not available , a biopsy of either the primary or metastatic site is required to determine their KRAS status . This is possible as status at the metastatic and primary tumour sites is considered to be similar . RESEARCH QUESTION To determine if there is predictive value of KRAS testing in guiding treatment decisions with anti-EGFR targeted therapies in advanced colorectal cancer patients refractory to chemotherapy . RESEARCH METHODS LITERATURE SEARCH The Medical Advisory Secretariat followed its st and ard procedures and on May 18 , 2010 , search ed the following electronic data bases : Ovid MEDLINE , EMBASE , Ovid MEDLINE In-Process & Other Non-Indexed Citations , Cochrane Central Register of Controlled Trials , Cochrane Data base of Systematic Review s and The International Network of Agencies for Health Technology Assessment data base . The subject headings and keywords search ed included colorectal cancer , cetuximab , panitumumab , and KRAS testing . The search was further restricted to English- language articles published between January 1 , 2009 and May 18 , 2010 result ing in 1335 articles for review . Excluded were case reports , comments , editorials , non systematic review s , and letters . Studies published from January 1 , 2005 to December 31 , 2008 were identified in a health technology assessment conducted by the Agency for Healthcare Research and Quality ( AHRQ ) , published in 2010 . In total , 14 observational studies were identified for inclusion in this EBA : 4 for cetuximab monotherapy , 7 for the cetuximab-irinotecan combination therapy , and 3 to be included in the review for panitumumab monotherapy INCLUSION CRITERIA English- language articles , and English or French- language HTAs published from January 2005 to May 2010 , inclusive . R and omized controlled trials ( RCTs ) or observational studies , including single arm treatment studies that include KRAS testing . Studies with data on main outcomes of interest , overall and progression-free survival . Studies of third line treatment with cetuximab or panitumumab in patients with advanced colorectal cancer refractory to chemotherapy . For the cetuximab-irinotecan evaluation , studies in which at least 70 % of patients in the study received this combination therapy . EXCLUSION CRITERIA Studies whose entire sample was included in subsequent publications which have been included in this EBA . Studies in pediatric population s . Case reports , comments , editorials , or letters . OUTCOMES OF INTEREST Overall survival ( OS ) , medianProgression-free-survival ( PFS ) , median . Response rates . Adverse event rates . Quality of life ( QOL ) . SUMMARY OF FINDINGS OF SYSTEMATIC REVIEW : CETUXIMAB OR PANITUMUMAB MONOTHERAPY : Based on moderate GRADE observational evidence , there is improvement in PFS and OS favouring patients without the KRAS mutation ( KRAS wildtype , or KRAS WT ) compared to those with the mutation . CETUXIMAB-IRINOTECAN COMBINATION THERAPY : There is low GRADE evidence that testing for KRAS may optimize survival benefits in patients without the KRAS mutation ( KRAS wildtype , or KRAS WT ) compared to those with the mutation . However , cetuximab-irinotecan combination treatments based on KRAS status discount any effect of cetuximab in possibly reversing resistance to irinotecan in patients with the mutation , as observed effects were lower than for patients without the mutation . Clinical experts have raised concerns about the biological plausibility of this observation and this conclusion would , therefore , be regarded as hypothesis generating . ECONOMIC ANALYSIS Cost-effectiveness and budget impact analyses were conducted incorporating estimates of effectiveness from this systematic review . Evaluation of relative cost-effectiveness , based on a decision-analytic cost-utility analysis , assessed testing for KRAS genetic mutations versus no testing in the context of treatment with cetuximab monotherapy , panitumumab monotherapy , cetuximab in combination with irinotecan , and best supportive care . Of importance to note is that the cost-effectiveness analysis focused on the impact of testing for KRAS mutations compared to no testing in the context of different treatment options , and does not assess the cost-effectiveness of the drug treatments alone . CONCLUSIONS KRAS status is predictive of outcomes in cetuximab and panitumumab monotherapy , and in cetuximab-irinotecan combination therapy . While KRAS testing is cost-effective for all strategies considered , it is not equally cost-effective for all treatment options
Output:
| Some studies reported that biomarkers were cost-effective , while their corresponding therapies were not cost-effective .
Conclusion Cancer biomarkers for targeted therapies in mCRC were mostly found to be cost-effective ; otherwise , they at least improved the cost-effectiveness of targeted therapies by saving some costs .
However , this did not necessarily make their corresponding therapies cost-effective .
While companion biomarkers reduced therapy costs , the savings were not sufficient to make the corresponding agents cost-effective . |
MS213934 | ***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 Smoking is one of the top preventable causes of mortality in people with psychotic disorders such as schizophrenia . Cessation treatment improves abstinence outcomes , but access is a barrier . Mobile phone apps are one way to increase access to cessation treatment ; however , whether they are usable by people with psychotic disorders , who often have special learning needs , is not known . Objective Research ers review ed 100 r and omly selected apps for smoking cessation to rate them based on US guidelines for nicotine addiction treatment and to categorize them based on app functions . We aim ed to test the usability and usefulness of the top-rated apps in 21 smokers with psychotic disorders . Methods We identified 766 smoking cessation apps and r and omly selected 100 for review . Two independent review ers rated each app with the Adherence Index to US Clinical Practice Guideline for Treating Tobacco Use and Dependence . Then , smokers with psychotic disorders evaluated the top 9 apps within a usability testing protocol . We analyzed quantitative results using descriptive statistics and t tests . Qualitative data were open-coded and analyzed for themes . Results Regarding adherence to practice guidelines , most of the r and omly sample d smoking cessation apps scored poorly—66 % rated lower than 10 out of 100 on the Adherence Index ( Mean 11.47 , SD 11.8 ) . Regarding usability , three common usability problems emerged : text-dense content , abstract symbols on the homepage , and subtle directions to edit features . Conclusions In order for apps to be effective and usable for this population , developers should utilize a balance of text and simple design that facilitate ease of navigation and content comprehension that will help people learn quit smoking skills Background The use of mobile apps for health and well being promotion has grown exponentially in recent years . Yet , there is currently no app- quality assessment tool beyond “ star”-ratings . Objective The objective of this study was to develop a reliable , multidimensional measure for trialling , classifying , and rating the quality of mobile health apps . Methods A literature search was conducted to identify articles containing explicit Web or app quality rating criteria published between January 2000 and January 2013 . Existing criteria for the assessment of app quality were categorized by an expert panel to develop the new Mobile App Rating Scale ( MARS ) subscales , items , descriptors , and anchors . There were sixty well being apps that were r and omly selected using an iTunes search for MARS rating . There were ten that were used to pilot the rating procedure , and the remaining 50 provided data on interrater reliability . Results There were 372 explicit criteria for assessing Web or app quality that were extracted from 25 published papers , conference proceedings , and Internet re sources . There were five broad categories of criteria that were identified including four objective quality scales : engagement , functionality , aesthetics , and information quality ; and one subjective quality scale ; which were refined into the 23-item MARS . The MARS demonstrated excellent internal consistency ( alpha = .90 ) and interrater reliability intraclass correlation coefficient ( ICC = .79 ) . Conclusions The MARS is a simple , objective , and reliable tool for classifying and assessing the quality of mobile health apps . It can also be used to provide a checklist for the design and development of new high quality health apps Background Smartphones are increasingly receiving attention from public health scholars and practitioners as a means to assist individuals ’ health management . A number of smartphone apps for smoking cessation are also available ; however , little effort has been made to evaluate the content and functions of these apps employing a theoretical framework . Objective The present study aims to analyze and evaluate the contents of smoking cessation apps available in South Korea employing the self-determination theory ( SDT ) as a theoretical framework for analysis . This study analyzes the extent to which smoking cessation apps have features that satisfy the basic needs identified in the SDT , which stimulate autonomous motivation . The type of motivational goal content manifested in the apps and how the goal content was framed are also explored . By assessing the features of smoking cessation apps based on the SDT , this study aims to offer direction for improvement for these apps . Methods Out of 309 apps identified from the iTunes store and Google Play ( excluding 27 duplications ) , 175 apps were r and omly drawn and analyzed . The coding scheme was drafted by the authors based on the SDT and gain/loss framing theory and was further finely tuned through the process of coder training and by establishing intercoder reliability . Once the intercoder reliability was established , the coders divided up the rest of the sample and coded them independently . Results The analysis revealed that most apps ( 94.3 % , 165/175 ) had at least one feature that tapped at least 1 of the 3 basic needs . Only 18 of 175 apps ( 10.3 % ) addressed all 3 basic needs . For goal content , money ( 53.7 % , 94/175 ) showed the highest frequency , followed by health ( 32.0 % , 56/175 ) , time ( 7.4 % , 13/175 ) , and appearance ( 1.1 % , 2/175 ) , suggesting that extrinsic goals are more dominantly presented in smoking cessation apps . For the framing of goal content , gain framing appeared more frequently ( 41.7 % , 73/175 ) . Conclusions The results suggest that these smoking cessation apps may not sufficiently stimulate autonomous motivation ; a small number of apps addressed all 3 basic needs suggested by the SDT ( ie , autonomy , competence , and relatedness ) . The apps also tended to present extrinsic goal content ( primarily in terms of money ) over intrinsic ones ( ie , health ) by primarily adopting gain framing . Implication s of these findings for public health practitioners and consumers are discussed Mobile health ( m-health ) apps can bring health prevention and promotion to the general population . The main purpose of this article is to analyze different m-health apps for a broad spectrum of consumers by means of three different experiences . This goal was defined following the strategic documents generated by the main prospect i ve observatories of Information and Communications Technology for health . After a general exploration of the app markets , we analyze the entries of three specific themes focused in this article : type 2 diabetes , obesity , and breast-feeding . The user experiences reported in this study mostly cover the segments of ( 1 ) chronically monitored consumers through a Web mobile app for predicting type 2 diabetes ( Diab_Alert app ) , ( 2 ) information seekers through a mobile app for maternity ( Lactation app ) and partially ( 3 ) the motivated healthy consumers through a mobile app for a dietetic monitoring and assessment ( SapoFit app ) . These apps were developed by the authors of this work Background Regular physical activity is known to help prevent and treat numerous non-communicable diseases . Smartphone applications ( apps ) have been shown to increase physical activity in primary care but little is known regarding the views of patients using such technology or how such technology may change behaviour . Aim To explore patients ’ views and experiences of using smartphones to promote physical activity in primary care . Design and setting This qualitative study was embedded within the SMART MOVE r and omised controlled trial , which used an app ( Accupedo-Pro Pedometer ) to promote physical activity in three primary care centres in the west of Irel and . Method Taped and transcribed semi-structured interviews with a purpose ful sample of 12 participants formed the basis of the investigation . Framework analysis was used to analyse the data . Results Four themes emerged from the analysis : transforming relationships with exercise ; persuasive technology tools ; usability ; and the cascade effect . The app appeared to facilitate a sequential and synergistic process of positive change , which occurred in the relationship between the participants and their exercise behaviour ; the study has termed this the ‘ Know-Check-Move ’ effect . Usability challenges included increased battery consumption and adjusting to carrying the smartphone on their person . There was also evidence of a cascade effect involving the families and communities of participants . Conclusion Notwithst and ing technological challenges , an app has the potential to positively transform , in a unique way , participants ’ relationships with exercise . Such interventions can also have an associated cascade effect within their wider families and communities Objective To carry out a r and omised controlled trial on the effect of a new method of health promotion — email and mobile phone text messages ( short messaging service (SMS))—on young people 's sexual health . Methods 994 people aged 16–29 were recruited at a music festival to a non-blinded r and omised controlled trial . Participants were r and omised to either receive sexual health promotion messages ( n=507 ) or the control group ( n=487 ) . The 12-month intervention included SMS ( catchy sexually transmissible infections prevention slogans ) and emails . Participants completed question naires at the festival at baseline and online after 3 , 6 and 12 months . Outcomes were differences between the control and intervention groups in health-seeking behaviour , condom use with risky partners ( new or casual partners or two or more partners within 12 months ) and STI knowledge . Results 337 ( 34 % ) completed all three follow-up question naires and 387 ( 39 % ) completed the final question naire . At 12 months , STI knowledge was higher in the intervention group for both male ( OR=3.19 95 % CI 1.52 to 6.69 ) and female subjects ( OR=2.36 95 % CI 1.27 to 4.37 ) . Women ( but not men ) in the intervention group were more likely to have had an STI test ( OR=2.51 , 95 % CI 1.11 to 5.69 ) , or discuss sexual health with a clinician ( OR=2.92 , 95 % CI 1.66 to 5.15 ) than their control counterparts . There was no significant impact on condom use . Opinions of the messages were favourable . Conclusion This simple intervention improved STI knowledge in both sexes and STI testing in women , but had no impact on condom use . SMS and email are low cost , popular and convenient , and have considerable potential for health promotion . Clinical trial registration number Australian Clinical Trials Registry - ACTRN12605000760673 OBJECTIVE To evaluate smartphone apps intended for self-management of pain using quality assessment criteria and usability testing with prospect i ve users . DESIGN 1 ) Survey and content analysis of available apps ; and 2 ) individual usability study of two apps . SETTING University of Leeds , United Kingdom . PARTICIPANTS Forty-one participants ( aged 19 - 59 years ) with experience of chronic or recurrent pain episodes . METHODS We undertook a survey , content analysis , and quality appraisal of all currently available mobile phone apps for self-management of pain . Two apps were then selected and assessed with usability testing . RESULTS Twelve apps met the inclusion criteria . The quality assessment revealed wide variation in their clinical content , interface design , and usability to support self-management of pain . Very little user or clinician involvement was identified in the development of the apps . From the usability testing , participants stated a preference for an interface design employing a lighter color scheme and particular text font . Although very few participants were aware of pain-reporting apps prior to participation , many would consider use in the future . CONCLUSIONS Variation in app quality and a lack of user and clinician engagement in development were found across the pain apps in this research . Usability testing identified a range of user preferences . Although useful information was obtained , it would be beneficial to involve users earlier in the process of development , as well as establishing ways to merge end user requirements with evidence -based content , to provide high- quality and usable apps for self-management of pain Many smartphone applications ( apps ) for mental health ( MHapps ) are available to the public . However , few have been the subject of a r and omized controlled trial ( RCT ) , and the change processes that are hypothesized to mediate cl aim ed effects have not been previously studied . This RCT compared the efficacy of three publicly available MHapps to a waitlist control condition in a community sample , in which no MHapp was provided . The three MHapps included cognitive behavioural therapy ( CBT ) toolkit app MoodKit , mood tracking app MoodPrism , and CBT strategy app MoodMission . Participants were r and omly allocated to each condition , completed a baseline assessment , downloaded their allocated MHapp , and completed a second assessment 30 days later , with n = 226 included in final analyses ( 81 % female ; M age = 34 years ) . Compared to the control condition , all MHapp groups experienced increases in mental wellbeing , MoodKit and MoodMission groups experienced decreases in depression , and no groups experienced effects on anxiety . Mediated regressions revealed that increasing coping self-efficacy , rather than emotional self-awareness or mental health literacy , was the underlying process contributing to effects on mental health for all three MHapps . MHapps appear to be an effective solution for improving public mental health , notably by improving users ' confidence in their ability to cope
Output:
| The ABACUS is a reliable tool that can be used to determine the behavior change potential of apps .
This instrument fills a gap by allowing the evaluation of a large number of apps to be st and ardized across a range of health categories |
MS213935 | ***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 Treatments for small-cell lung cancer ( SCLC ) after failure of platinum-based chemotherapy are limited . We assessed safety and activity of nivolumab and nivolumab plus ipilimumab in patients with SCLC who progressed after one or more previous regimens . METHODS The SCLC cohort of this phase 1/2 multicentre , multi-arm , open-label trial was conducted at 23 sites ( academic centres and hospitals ) in six countries . Eligible patients were 18 years of age or older , had limited-stage or extensive-stage SCLC , and had disease progression after at least one previous platinum-containing regimen . Patients received nivolumab ( 3 mg/kg bodyweight intravenously ) every 2 weeks ( given until disease progression or unacceptable toxicity ) , or nivolumab plus ipilimumab ( 1 mg/kg plus 1 mg/kg , 1 mg/kg plus 3 mg/kg , or 3 mg/kg plus 1 mg/kg , intravenously ) every 3 weeks for four cycles , followed by nivolumab 3 mg/kg every 2 weeks . Patients were either assigned to nivolumab monotherapy or assessed in a dose-escalating safety phase for the nivolumab/ipilimumab combination beginning at nivolumab 1 mg/kg plus ipilimumab 1 mg/kg . Depending on tolerability , patients were then assigned to nivolumab 1 mg/kg plus ipilimumab 3 mg/kg or nivolumab 3 mg/kg plus ipilimumab 1 mg/kg . The primary endpoint was objective response by investigator assessment . All analyses included patients who were enrolled at least 90 days before data base lock . This trial is ongoing ; here , we report an interim analysis of the SCLC cohort . This study is registered with Clinical Trials.gov , number NCT01928394 . FINDINGS Between Nov 18 , 2013 , and July 28 , 2015 , 216 patients were enrolled and treated ( 98 with nivolumab 3 mg/kg , three with nivolumab 1 mg/kg plus ipilimumab 1 mg/kg , 61 with nivolumab 1 mg/kg plus ipilimumab 3 mg/kg , and 54 with nivolumab 3 mg/kg plus ipilimumab 1 mg/kg ) . At data base lock on Nov 6 , 2015 , median follow-up for patients continuing in the study ( including those who had died or discontinued treatment ) was 198·5 days ( IQR 163·0 - 464·0 ) for nivolumab 3 mg/kg , 302 days ( IQR not calculable ) for nivolumab 1 mg/kg plus ipilimumab 1 mg/kg , 361·0 days ( 273·0 - 470·0 ) for nivolumab 1 mg/kg plus ipilimumab 3 mg/kg , and 260·5 days ( 248·0 - 288·0 ) for nivolumab 3 mg/kg plus ipilimumab 1 mg/kg . An objective response was achieved in ten ( 10 % ) of 98 patients receiving nivolumab 3 mg/kg , one ( 33 % ) of three patients receiving nivolumab 1 mg/kg plus ipilimumab 1 mg/kg , 14 ( 23 % ) of 61 receiving nivolumab 1 mg/kg plus ipilimumab 3 mg/kg , and ten ( 19 % ) of 54 receiving nivolumab 3 mg/kg plus ipilimumab 1 mg/kg . Grade 3 or 4 treatment-related adverse events occurred in 13 ( 13 % ) patients in the nivolumab 3 mg/kg cohort , 18 ( 30 % ) in the nivolumab 1 mg/kg plus ipilimumab 3 mg/kg cohort , and ten ( 19 % ) in the nivolumab 3 mg/kg plus ipilimumab 1 mg/kg cohort ; the most commonly reported grade 3 or 4 treatment-related adverse events were increased lipase ( none vs 5 [ 8 % ] vs none ) and diarrhoea ( none vs 3 [ 5 % ] vs 1 [ 2 % ] ) . No patients in the nivolumab 1 mg/kg plus ipilimumab 1 mg/kg cohort had a grade 3 or 4 treatment-related adverse event . Six ( 6 % ) patients in the nivolumab 3 mg/kg group , seven ( 11 % ) in the nivolumab 1 mg/kg plus ipilimumab 3 mg/kg group , and four ( 7 % ) in the nivolumab 3 mg/kg plus ipilimumab 1 mg/kg group discontinued treatment due to treatment-related adverse events . Two patients who received nivolumab 1 mg/kg plus ipilimumab 3 mg/kg died from treatment-related adverse events ( myasthenia gravis and worsening of renal failure ) , and one patient who received nivolumab 3 mg/kg plus ipilimumab 1 mg/kg died from treatment-related pneumonitis . INTERPRETATION Nivolumab monotherapy and nivolumab plus ipilimumab showed antitumour activity with durable responses and manageable safety profiles in previously treated patients with SCLC . These data suggest a potential new treatment approach for a population of patients with limited treatment options and support the evaluation of nivolumab and nivolumab plus ipilimumab in phase 3 r and omised controlled trials in SCLC . FUNDING Bristol-Myers Squibb BACKGROUND Ipilimumab is an approved treatment for patients with advanced melanoma . We aim ed to assess ipilimumab as adjuvant therapy for patients with completely resected stage III melanoma at high risk of recurrence . METHODS We did a double-blind , phase 3 trial in patients with stage III cutaneous melanoma ( excluding lymph node metastasis ≤1 mm or in-transit metastasis ) with adequate resection of lymph nodes ( ie , the primary cutaneous melanoma must have been completely excised with adequate surgical margins ) who had not received previous systemic therapy for melanoma from 91 hospitals located in 19 countries . Patients were r and omly assigned ( 1:1 ) , central ly by an interactive voice response system , to receive intravenous infusions of 10 mg/kg ipilimumab or placebo every 3 weeks for four doses , then every 3 months for up to 3 years . Using a minimisation technique , r and omisation was stratified by disease stage and geographical region . The primary endpoint was recurrence-free survival , assessed by an independent review committee , and analysed by intention to treat . Enrollment is complete but the study is ongoing for follow-up for analysis of secondary endpoints . This trial is registered with EudraCT , number 2007 - 001974 - 10 , and Clinical Trials.gov , number NCT00636168 . FINDINGS Between July 10 , 2008 , and Aug 1 , 2011 , 951 patients were r and omly assigned to ipilimumab ( n=475 ) or placebo ( n=476 ) , all of whom were included in the intention-to-treat analyses . At a median follow-up of 2·74 years ( IQR 2·28 - 3·22 ) , there were 528 recurrence-free survival events ( 234 in the ipilimumab group vs 294 in the placebo group ) . Median recurrence-free survival was 26·1 months ( 95 % CI 19·3 - 39·3 ) in the ipilimumab group versus 17·1 months ( 95 % CI 13·4 - 21·6 ) in the placebo group ( hazard ratio 0·75 ; 95 % CI 0·64 - 0·90 ; p=0·0013 ) ; 3-year recurrence-free survival was 46·5 % ( 95 % CI 41·5 - 51·3 ) in the ipilimumab group versus 34·8 % ( 30·1 - 39·5 ) in the placebo group . The most common grade 3 - 4 immune-related adverse events in the ipilimumab group were gastrointestinal ( 75 [ 16 % ] vs four [ < 1 % ] in the placebo group ) , hepatic ( 50 [ 11 % ] vs one [ < 1 % ] ) , and endocrine ( 40 [ 8 % ] vs none ) . Adverse events led to discontinuation of treatment in 245 ( 52 % ) of 471 patients who started ipilimumab ( 182 [ 39 % ] during the initial treatment period of four doses ) . Five patients ( 1 % ) died due to drug-related adverse events . Five ( 1 % ) participants died because of drug-related adverse events in the ipilimumab group ; three patients died because of colitis ( two with gastrointestinal perforation ) , one patient because of myocarditis , and one patient because of multiorgan failure with Guillain-Barré syndrome . INTERPRETATION Adjuvant ipilimumab significantly improved recurrence-free survival for patients with completely resected high-risk stage III melanoma . The adverse event profile was consistent with that observed in advanced melanoma , but at higher incidences in particular for endocrinopathies . The risk-benefit ratio of adjuvant ipilimumab at this dose and schedule requires additional assessment based on distant metastasis-free survival and overall survival endpoints to define its definitive value . FUNDING Bristol-Myers Squibb BACKGROUND Results from phase 2 and 3 trials in patients with advanced melanoma have shown significant improvements in the proportion of patients achieving an objective response and prolonged progression-free survival with the combination of nivolumab ( an anti-PD-1 antibody ) plus ipilimumab ( an anti-CTLA-4 antibody ) compared with ipilimumab alone . We report 2-year overall survival data from a r and omised controlled trial assessing this treatment in previously untreated advanced melanoma . METHODS In this multicentre , double-blind , r and omised , controlled , phase 2 trial ( CheckMate 069 ) we recruited patients from 19 specialist cancer centres in two countries ( France and the USA ) . Eligible patients were aged 18 years or older with previously untreated , unresectable stage III or IV melanoma and an Eastern Cooperative Oncology Group performance status of 0 or 1 . Patients were r and omly assigned 2:1 to receive an intravenous infusion of nivolumab 1 mg/kg plus ipilimumab 3 mg/kg or ipilimumab 3 mg/kg plus placebo , every 3 weeks for four doses . Subsequently , patients assigned to nivolumab plus ipilimumab received nivolumab 3 mg/kg every 2 weeks until disease progression or unacceptable toxicity , whereas patients allocated to ipilimumab alone received placebo every 2 weeks during this phase . R and omisation was done via an interactive voice response system with a permuted block schedule ( block size of six ) and stratification by BRAF mutation status . The study funder , patients , investigators , and study site staff were masked to treatment assignment . The primary endpoint , which has been reported previously , was the proportion of patients with BRAFV600 wild-type melanoma achieving an investigator-assessed objective response . Overall survival was an exploratory endpoint and is reported in this Article . Efficacy analyses were done on the intention-to-treat population , whereas safety was assessed in all treated patients who received at least one dose of study drug . This study is registered with Clinical Trials.gov , number NCT01927419 , and is ongoing but no longer enrolling patients . FINDINGS Between Sept 16 , 2013 , and Feb 6 , 2014 , we screened 179 patients and enrolled 142 , r and omly assigning 95 patients to nivolumab plus ipilimumab and 47 to ipilimumab alone . In each treatment group , one patient no longer met the study criteria following r and omisation and thus did not receive study drug . At a median follow-up of 24·5 months ( IQR 9·1 - 25·7 ) , 2-year overall survival was 63·8 % ( 95 % CI 53·3 - 72·6 ) for those assigned to nivolumab plus ipilimumab and 53·6 % ( 95 % CI 38·1 - 66·8 ) for those assigned to ipilimumab alone ; median overall survival had not been reached in either group ( hazard ratio 0·74 , 95 % CI 0·43 - 1·26 ; p=0·26 ) . Treatment-related grade 3 - 4 adverse events were reported in 51 ( 54 % ) of 94 patients who received nivolumab plus ipilimumab compared with nine ( 20 % ) of 46 patients who received ipilimumab alone . The most common treatment-related grade 3 - 4 adverse events were colitis ( 12 [ 13 % ] of 94 patients ) and increased alanine aminotransferase ( ten [ 11 % ] ) in the combination group and diarrhoea ( five [ 11 % ] of 46 patients ) and hypophysitis ( two [ 4 % ] ) in the ipilimumab alone
Output:
| There was no significant difference in any grade pneumonitis and pneumonia in cytotoxic T lymphocyte-associated protein 4 ( CTLA4 ) inhibitors subgroup .
Conclusions : PD-1/PD-L1 inhibitors treatment could increase the risk of all- grade pneumonitis .
CTLA4 inhibitor ipilimumab treatment alone could not increase the risk of pneumonitis but could augment the risk of pneumonitis in PD-1/PD-L1 inhibitor treated patients .
There was no significant increase in the risk of pneumonia after either PD-1/PDL-1inhibitor or CTLA4 inhibitor treatment alone or in combination |
MS213936 | ***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 explore whether adding a gender and HIV training programme to microfinance initiatives can lead to health and social benefits beyond those achieved by microfinance alone . METHODS Cross-sectional data were derived from three r and omly selected matched clusters in rural South Africa : ( i ) four villages with 2-year exposure to the Intervention with Microfinance for AIDS and Gender Equity ( IMAGE ) , a combined microfinance-health training intervention ; ( ii ) four villages with 2-year exposure to microfinance services alone ; and ( iii ) four control villages not targeted by any intervention . Adjusted risk ratios ( aRRs ) employing village-level summaries compared associations between groups in relation to indicators of economic well-being , empowerment , intimate partner violence ( IPV ) and HIV risk behaviour . The magnitude and consistency of aRRs allowed for an estimate of incremental effects . FINDINGS A total of 1409 participants were enrolled , all female , with a median age of 45 . After 2 years , both the microfinance-only group and the IMAGE group showed economic improvements relative to the control group . However , only the IMAGE group demonstrated consistent associations across all domains with regard to women 's empowerment , intimate partner violence and HIV risk behaviour . CONCLUSION The addition of a training component to group-based microfinance programmes may be critical for achieving broader health benefits . Donor agencies should encourage intersectoral partnerships that can foster synergy and broaden the health and social effects of economic interventions such as microfinance Background Women who engage in sex work are at risk for experiencing violence from numerous perpetrators , including paying partners . Empirical evidence has shown mixed results regarding the impact of participation in microfinance interventions on women ’s experiences of violence , with some studies demonstrating reductions in intimate partner violence ( IPV ) and others showing heightened risk for IPV . The current study reports on the impact of participation in a microsavings intervention on experiences of paying partner violence among women engaged in sex work in Mongolia . Methods Between 2011 and 2013 , we conducted a two-arm , non-blinded r and omized controlled trial ( RCT ) comparing an HIV/STI risk reduction intervention ( HIVSRR ) ( control condition ) to a combined microsavings and HIVSRR intervention ( treatment condition ) . Eligible women ( aged 18 or older , reported having engaged in unprotected sex with paying partner in past 90 days , expressed interest in microsavings intervention ) were invited to participate . One hundred seven were r and omized , including 50 in the control and 57 in the treatment condition . Participants completed assessment s at baseline , immediate post-test following HIVSRR , and at 3-months and 6-months after completion of the treatment group intervention . Outcomes for the current study include any violence ( physical and /or sexual ) , sexual violence , and physical violence from paying partners in the past 90 days . Results An intention-to-treat approach was utilized . Linear growth models revealed significant reductions over time in both conditions for any violence ( β = −0.867 , p < 0.001 ) , physical violence ( β = −0.0923 , p < 0.001 ) , and sexual violence ( β = −1.639 , p = 0.001 ) from paying partners . No significant differences between groups were found for any violence ( β = 0.118 , p = 0.389 ) , physical violence ( β = 0.091 , p = 0.792 ) , or sexual violence ( β = 0.379 , p = 0.114 ) from paying partners . Conclusions Microsavings participation did not significantly impact women ’s risk for paying partner violence . Qualitative research is recommended to underst and the cause for reductions in paying partner violence in both study conditions . Trial registration Evaluating a Microfinance Intervention for High Risk Women in Mongolia ; NCT01861431 ; May 20 , 2013 Intimate partner violence is widespread and represents an obstacle to human freedom and a significant public health concern . Poverty alleviation programs and efforts to economically " empower " women have become popular policy options , but theory and empirical evidence are mixed on the relationship between women 's empowerment and the experience of violence . We study the effects of a successful poverty alleviation program on women 's empowerment and intimate partner relations and violence from 2009 to 2011 . In the first experiment , a cluster-r and omized superiority trial , 15 marginalized people ( 86 % women ) were identified in each of 120 villages ( n = 1800 ) in Gulu and Kitgum districts in Ug and a. Half of villages were r and omly assigned via public lottery to immediate treatment : five days of business training , $ 150 , and supervision and advising . We examine intent-to-treat estimates of program impact and heterogeneity in treatment effects by initial quality of partner relations . 16 months after the initial grants , the program doubled business ownership and incomes ( p < 0.01 ) ; we show that the effect on monthly income , however , is moderated by initial quality of intimate partner relations . We also find small increases in marital control ( p < 0.05 ) , self-reported autonomy ( p < 0.10 ) , and quality of partner relations ( p < 0.01 ) , but essentially no change in intimate partner violence . In a second experiment , we study the impact of a low-cost attempt to include household partners ( often husb and s ) in the process . Participants from the 60 waitlist villages ( n = 904 ) were r and omly assigned to participate in the program as individuals or with a household partner . We observe small , non-significant decreases in abuse and marital control and large increases in the quality of relationships ( p < 0.05 ) , but no effects on women 's attitudes toward gender norms and a non-significant reduction in autonomy . Involving men and changing framing to promote more inclusive programming can improve relationships , but may not change gender attitudes or increase business success . Increasing women 's earnings has no effect on intimate partner violence BACKGROUND HIV infection and intimate-partner violence share a common risk environment in much of southern Africa . The aim of the Intervention with Microfinance for AIDS and Gender Equity ( IMAGE ) study was to assess a structural intervention that combined a microfinance programme with a gender and HIV training curriculum . METHODS Villages in the rural Limpopo province of South Africa were pair-matched and r and omly allocated to receive the intervention at study onset ( intervention group , n=4 ) or 3 years later ( comparison group , n=4 ) . Loans were provided to poor women who enrolled in the intervention group . A participatory learning and action curriculum was integrated into loan meetings , which took place every 2 weeks . Both arms of the trial were divided into three groups : direct programme participants or matched controls ( cohort one ) , r and omly selected 14 - 35-year-old household co-residents ( cohort two ) , and r and omly selected community members ( cohort three ) . Primary outcomes were experience of intimate-partner violence -- either physical or sexual -- in the past 12 months by a spouse or other sexual intimate ( cohort one ) , unprotected sexual intercourse at last occurrence with a non-spousal partner in the past 12 months ( cohorts two and three ) , and HIV incidence ( cohort three ) . Analyses were done on a per- protocol basis . This trial is registered with Clinical Trials.gov , number NCT00242957 . FINDINGS In cohort one , experience of intimate-partner violence was reduced by 55 % ( adjusted risk ratio [ aRR ] 0.45 , 95 % CI 0.23 - 0.91 ; adjusted risk difference -7.3 % , -16.2 to 1.5 ) . The intervention did not affect the rate of unprotected sexual intercourse with a non-spousal partner in cohort two ( aRR 1.02 , 0.85 - 1.23 ) , and there was no effect on the rate of unprotected sexual intercourse at last occurrence with a non-spousal partner ( 0.89 , 0.66 - 1.19 ) or HIV incidence ( 1.06 , 0.66 - 1.69 ) in cohort three . INTERPRETATION A combined microfinance and training intervention can lead to reductions in levels of intimate-partner violence in programme participants . Social and economic development interventions have the potential to alter risk environments for HIV and intimate-partner violence in southern Africa OBJECTIVES We sought to obtain evidence about the scope of women 's empowerment and the mechanisms underlying the significant reduction in intimate partner violence documented by the Intervention With Microfinance for AIDS and Gender Equity ( IMAGE ) cluster-r and omized trial in rural South Africa . METHODS The IMAGE intervention combined a microfinance program with participatory training on underst and ing HIV infection , gender norms , domestic violence , and sexuality . Outcome measures included past year 's experience of intimate partner violence and 9 indicators of women 's empowerment . Qualitative data about changes occurring within intimate relationships , loan groups , and the community were also collected . RESULTS After 2 years , the risk of past-year physical or sexual violence by an intimate partner was reduced by more than half ( adjusted risk ratio=0.45 ; 95 % confidence interval=0.23 , 0.91 ) . Improvements in all 9 indicators of empowerment were observed . Reductions in violence result ed from a range of responses enabling women to challenge the acceptability of violence , expect and receive better treatment from partners , leave abusive relationships , and raise public awareness about intimate partner violence . CONCLUSIONS Our findings , both qualitative and quantitative , indicate that economic and social empowerment of women can contribute to reductions in intimate partner violence BACKGROUND Cash transfers have been proposed as an intervention to reduce HIV-infection risk for young women in sub-Saharan Africa . However , scarce evidence is available about their effect on reducing HIV acquisition . We aim ed to assess the effect of a conditional cash transfer on HIV incidence among young women in rural South Africa . METHODS We did a phase 3 , r and omised controlled trial ( HPTN 068 ) in the rural Bushbuckridge subdistrict in Mpumalanga province , South Africa . We included girls aged 13 - 20 years if they were enrolled in school grade s 8 - 11 , not married or pregnant , able to read , they and their parent or guardian both had the necessary documentation necessary to open a bank account , and were residing in the study area and intending to remain until trial completion . Young women ( and their parents or guardians ) were r and omly assigned ( 1:1 ) , by use of numbered sealed envelopes containing a r and omisation assignment card which were numerically ordered with block r and omisation , to receive a monthly cash transfer conditional on school attendance ( ≥80 % of school days per month ) versus no cash transfer . Participants completed an Audio Computer-Assisted Self-Interview ( ACASI ) , before test HIV counselling , HIV and herpes simplex virus (HSV)-2 testing , and post-test counselling at baseline , then at annual follow-up visits at 12 , 24 , and 36 months . Parents or guardians completed a Computer-Assisted Personal Interview at baseline and each follow-up visit . A stratified proportional hazards model was used in an intention-to-treat analysis of the primary outcome , HIV incidence , to compare the intervention and control groups . This study is registered at Clinical Trials.gov ( NCT01233531 ) . FINDINGS Between March 5 , 2011 , and Dec 17 , 2012 , we recruited 10 134 young women and enrolled 2537 and their parents or guardians to receive a cash transfer programme ( n=1225 ) or not ( control group ; n=1223 ) . At baseline , the median age of girls was 15 years ( IQR 14 - 17 ) and 672 ( 27 % ) had reported to have ever had sex . 107 incident HIV infections were recorded during the study : 59 cases in 3048 person-years in the intervention group and 48 cases in 2830 person-years in the control group . HIV incidence was not significantly different between those who received a cash transfer ( 1·94 % per person-years ) and those who did not ( 1·70 % per person-years ; hazard ratio 1·17 , 95 % CI 0·80 - 1·72 , p=0·42 ) . INTERPRETATION Cash transfers conditional on school attendance did not reduce HIV incidence in young women . School attendance significantly reduced risk of HIV acquisition , irrespective of study group . Keeping girls in school is important to reduce their HIV-infection risk . FUNDING National Institute of Allergy and Infectious Diseases , National Institute of Mental Health of the National Institutes of Health Violence against women is a major health and human rights problem yet there is little rigorous evidence as to how to reduce it . We take advantage of the r and omized roll-out of Ecuador 's cash transfer program to mothers to investigate how an exogenous increase in a woman 's income affects domestic violence . We find that the effect of a cash transfer depends on a woman 's education and on her education relative to her partner 's . Our results show that for women with greater than primary school education a cash transfer significantly decreases psychological violence from her partner . For women with primary school education or less , however , the effect of a cash transfer depends on her education relative to her partner 's . Specifically , the cash transfer significantly increases emotional violence in households where the woman 's education is equal to or more than her partner 's
Output:
| Our results showed that the impact of MP are mixed when it comes to physical and physical/sexual violence .
Even so , the review suggests that the effect of MP on sexual violence is trivial or nonexistent .
Regarding the impact of CTPs , the present study showed that the effects on physical , physical/sexual , psychological , and sexual violence were also heterogeneous .
Women more empowered and with some autonomy could be at risk . |
MS213937 | ***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 AND OBJECTIVE Nausea and vomiting are major inconveniences for patients undergoing chemotherapy . Despite st and ard preventive treatment , chemotherapy-induced nausea and vomiting ( CINV ) still occurs in approximately 50 % of these patients . In an attempt to optimize this treatment , we evaluated the possible effects of carbamazepine for prevention of CINV . DESIGN AND LOCATION Prospect i ve nonr and omized open-label phase II study carried out at a Brazilian public oncology service . METHODS Patients allocated for their first cycle of highly emetogenic chemotherapy were continuously recruited . In addition to st and ard antiemetic protocol that was made available , they received carbamazepine orally , with staggered doses , from the third day before until the fifth day after chemotherapy . Considering the sparseness of evidence about the efficacy of anticonvulsants for CINV prevention , we used Simon 's two-stage design , in which 43 patients should be included unless overall complete prevention was not achieved in 9 out of the first 15 entries . The Functional Living Index-Emesis question naire was used to measure the impact on quality of life . RESULTS None of the ten patients ( 0 % ) presented overall complete prevention . In three cases , carbamazepine therapy was withdrawn because of somnolence and vomiting before chemotherapy . Seven were able to take the medication for the entire period and none were responsive , so the study was closed . There was no impact on the patients ' quality of life . CONCLUSION Carbamazepine was not effective for prevention of CINV and also had a deleterious side-effect profile in this population BACKGROUND Delayed chemotherapy-induced nausea and vomiting ( CINV ) remains a major adverse effect of cancer chemotherapy . We assessed , under current practice patterns , the occurrence and impact on healthcare re source utilization of CINV in patients receiving emetogenic chemotherapy . An additional aim of this study was to estimate costs imputable to CINV in the German healthcare environment . MATERIAL S AND METHODS This prospect i ve , multi-center , cross-sectional cost-of-illness study was conducted in three hospitals and in three office-based facilities in Germany . Consecutive patients undergoing emetogenic chemotherapy ( levels 4 or 5 according to Hesketh classification of emetogenicity ) were enrolled . Data were obtained from preplanned chart review s and from self-administered patient question naires . Analysis of direct costs was performed from the perspectives of third party payer ( statutory sick fund ) , provider ( hospital ) and patients . Indirect costs were assessed on the basis of paid workdays lost . RESULTS During the 5-day observation period , 134 of 208 chemotherapy cycles observed ( 64.4 % ) were associated with at least one episode of nausea or vomiting . More patients experienced delayed than acute CINV ( 60.7 % versus 32.8 % ) , and more patients reported nausea than vomiting ( 62.5 % versus 26.0 % ) . A total of 68 patients ( 32.6 % ) utilized healthcare re sources due to CINV . The most frequently used re sources were rescue medications and outpatient hospital and office physician visits . Only one patient required hospitalization and only three patients lost workdays due to CINV . Average costs imputable to CINV per patient ( with or without CINV ) per treatment cycle incurred by third party payers and hospital providers were Euro 49 and Euro 48 , respectively . Patient or treatment characteristics that were associated with high costs imputable to CINV were as follows : cisplatin-containing regimen ; experience of emesis ; and presence of delayed CINV . CONCLUSIONS A substantial proportion of patients continue to experience CINV . This entails not only clinical but also economic consequences , and highlights a continuing need for improved utilization of existing antiemetic agents and for new , more efficacious treatments . The greatest improvements in patient care and potential for cost offset may be realized by preventing delayed CINV INTRODUCTION Chemotherapy-induced nausea and vomiting ( CINV ) is one of the most important worries of cancer patients . Although not life-threatening , it has a great negative impact on quality of life ( QOL ) . OBJECTIVE The aim of this study was to determine the impact of CINV ( i.e. , acute and delayed ) on breast cancer patients QOL and to discern opinions related with antiemetic guidelines used dependent on the three main races in Malaysia ( Malay , Chinese , Indian ) . METHODS In this longitudinal prospect i ve observational study , 158 breast cancer patients treated with chemotherapy were interviewed and valid question naires ( MANE and ONEM ) were used to report the impact of CINV on their QOL within the first 24 hours and after 3 to 5 days of chemotherapy treatment . RESULTS The main result was that delayed CINV has an impact on QOL greater than acute CINV . The impact of nausea was reportedly higher than that of vomiting . Also differences in race i.e. , genetic polymorphisms ( pharmacogenomics ) influenced the utility of antiemetic treatments and patients opinions . CONCLUSION Based on the results of our study a new guideline for antiemetic treatment should be used to reduce the impact of CINV on QOL , taking into account variation in genetic polymorphisms among the three races in Malaysia This study compared the efficacy and tolerability of oral ondansetron ( 8 mg twice daily [ BID ] for up to 3 days ) with those of phenothiazine prochlorperazine ( 10 mg BID for up to 3 days ) in 133 cancer patients receiving cyclophosphamide-based chemotherapy . In addition , the study evaluated the impact of these treatments on patients ' health-related quality of life , measured with both the Functional Living Index -- Cancer and the Functional Living Index -- Emesis question naires . The first dose of study drug was administered 30 minutes before initiation of chemotherapy . Patients received a rescue antiemetic at their request or if the investigator deemed it necessary . There was a statistically significant difference in the number of patients with no emetic episodes over the 3-day study period : 60 % in the ondansetron group compared with 21 % in the prochlorperazine group . Twenty-five percent of ondansetron-treated patients compared with 68 % of prochlorperazine-treated patients experienced three or more emetic episodes , rescue medication use , or withdrawal from the study due to adverse events or lack of efficacy of the study drug . Among patients with at least one emetic episode , the mean time to emesis was significantly longer ( 13 hours and 37 minutes ) in the ondansetron group compared with the prochlorperazine group ( 9 hours and 30 minutes ) . Nausea and appetite scores did not differ significantly between groups . The score on the vomiting subscale of the Functional Living Index -- Emesis was significantly more favorable in the ondansetron group compared with the prochlorperazine group , indicating better maintenance of health-related quality of life in ondansetron-treated patients . Both treatments were well tolerated . The most common potentially drug-related adverse event was headache , which occurred in significantly more ( 16 % ) ondansetron-treated patients compared with prochlorperazine-treated patients ( 3 % ) . The results of this study demonstrate that oral ondansetron 8 mg BID for up to 3 days is more effective than prochlorperazine 10 mg BID for up to 3 days in the prevention of emesis associated with moderately emetogenic chemotherapy Objectives Chemotherapy-induced nausea and vomiting ( CINV ) remains a major adverse effect of cancer chemotherapy which may increase morbidity , reduce quality of life and threaten the success of cancer therapy . Aprepitant is effective in preventing CINV , achieving higher complete response ( no emesis and no rescue therapy ) compared to st and ard prevention , in patients receiving either highly ( HEC ) or moderately emetogenic chemotherapy ( MEC ; absolute reduction = 11 and 13 % , respectively ) . We assessed the cost effectiveness of aprepitant-based vs st and ard prevention in these indications in Belgium . Material s and methods A decision analytical model was developed in MS Excel ( Fig. 1 ) . To estimate re source use , two approaches were used . The first is based on the preventive regimens applied in r and omized controlled trials comparing aprepitant-based CINV prevention ( for HEC : aprepitant days 1–3 , ondansetron 32 mg i.v . day 1 , oral placebo twice daily days 2–4 , oral dexamethasone days 1–4 ; for MEC : aprepitant days 1–3 , ondansetron 16 mg p.o . day 1 , placebo on days 2–3 , oral dexamethasone day 1 ) , vs a st and ard regimen ( for HEC : oral placebo days 1–3 , ondansetron 32 mg i.v . day 1 and 16 mg p.o . days 2–4 , oral dexamethasone days 1–4 ; for MEC : oral placebo , ondansetron 16 mg p.o . days 1–3 , dexamethasone day 1 ) The second analysis is based on current real-world re source use in the Belgian setting in the prevention of CINV using a longitudinal Hospital Data base . CINV-specific utility values were used to calculate quality -adjusted life years ( QALYs ) . Drug costs were obtained from official reimbursement listings . Treatment costs for CINV were obtained from a German study and adapted to Belgium . Results The aprepitant-based regimen is associated with 0.003 and 0.014 more QALYs in HEC and MEC , respectively and with per patient savings of € 66.84 ( trial based ) and € 74.62 ( real-life based ) for HEC and € 17.95 ( trial based ) and € 21.70 ( real-life based ) for MEC . Hence , aprepitant is both more effective and less expensive ( = dominant ) . One-way sensitivity analyses were performed on treatment cost of emesis , the clinical benefit of aprepitant and the cost of ondansetron and showed that the results were robust on the first two parameters but sensitive on the decrease in cost of ondansetron for the moderately emetogenic chemotherapy regimens . Conclusions In both approaches , the aprepitant-based strategy is more effective and less expensive compared to st and ard care Purpose Nausea is a troublesome and distressing symptom for patients receiving chemotherapy . While vomiting is well controlled with current antiemetics , nausea is a more difficult symptom to manage . The aim of this study was to assess the impact of nausea on nutritional status , quality of life and psychological distress . Methods This was a prospect i ve observational study over two cycles of chemotherapy . Patients completed the Multinational Association of Supportive Care in Cancer Antiemesis Tool , a measure of nutritional status ( Patient-Generated Subjective Global Assessment ) , the Functional Assessment of Cancer Therapy-General ( FACT-G ) quality of life scale and the Hospital Anxiety and Depression Scale at the end of each chemotherapy cycle ( around day 10 post-chemotherapy ) . Results The sample consisted of 104 patients , primarily female , receiving anthracycline-based chemotherapy . While vomiting was minimal ( 5.2–14.6 % of the patients ) , high levels of nausea were observed ( 55.2–72.9 % ) , and severe nausea ( > 6 on a 0–10 scale ) was reported by 20.5–29.2 % of the participants . Severe nausea had a borderline significant impact in relation to physical functioning ( p = 0.025 ) and a significant impact on nutritional status ( severe acute nausea , p = 0.003 ; severe delayed nausea , p = 0.017 ) . Clinical ly meaningful changes were observed in relation to the FACT-G total score . Conclusion Chemotherapy-induced nausea does have an impact on nutritional status and physical functioning and can impair anxiety and quality of life . As a key symptom associated with other symptoms , it is imperative that greater attention is given to managing treatment-related nausea through innovative non-pharmacological and nutritional interventions Purpose Addition of rolapitant to st and ard antiemetic therapy improved protection against chemotherapy-induced nausea and vomiting ( CINV ) in phase 3 trials of patients receiving highly emetogenic chemotherapy ( HEC ) or moderately emetogenic chemotherapy ( MEC ) . Here , we assessed the impact of CINV on the daily lives of patients receiving HEC or MEC using the Functional Living Index-Emesis ( FLIE ) . Methods In three double-blind phase 3 studies , patients receiving HEC or MEC were r and omized 1:1 to receive oral rolapitant 180 mg or placebo prior to chemotherapy plus 5-hydroxytryptamine type 3 receptor antagonist and dexamethasone therapy . Patients completed the FLIE question naire on day 6 of cycle 1 . Endpoints included FLIE total score , nausea and vomiting domain scores , and the proportion of patients with no impact on daily life ( total score > 108 [ range 18–126 ] ) . We performed a prespecified analysis of the MEC/anthracycline-cyclophosphamide ( AC ) study and a post hoc analysis of two pooled cisplatin-based HEC studies . Results In the pooled HEC studies , rolapitant significantly improved the FLIE total score ( 114.5 vs 109.3 , p < 0.001 ) , nausea score ( 55.3 vs 53.5 , p < 0.05 ) , and vomiting score ( 59.2
Output:
| Despite the availability of numerous treatment options , CINV was found to have a strong impact on HRQoL of patients .
Direct costs are particularly affected , but this result could be due to scarcity of studies assessing indirect costs .
Evidence supports the notion that CINV continues to have a negative impact on HRQoL of patients , even for those receiving moderately emetic chemotherapy . |
MS213938 | ***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: Objectives To evaluate the ability of the Behavioral Indicators of Infant Pain ( BIIP ) scale to discriminate between skin-breaking and nonskin breaking procedures , and to identify sensitized pain responses in preterm infants in the neonatal intensive care unit ( NICU ) . Methods Sixty-nine infants born between 24 and 32 weeks gestational age were assessed at 32 weeks postconceptional age during blood collection on one day ( procedure A ) , and then on another day during blood collection preceded by a diaper change ( procedure B ) . Procedure order was r and omized . Outcome measures were changes in BIIP coded from continuous bedside video recordings and changes in heart rate ( HR ) . Results During blood collection ( procedure A ) , BIIP scores ( P<0.0001 ) and mean HR ( P<0.0001 ) were higher than during the diaper change and higher when the infants had had a preceding diaper change ( procedure B vs. procedure A ) ( P<0.03 ) . HR changed from baseline to the stressors for each procedure . No differences in mean HR were observed during Lance phase between the procedure A and the B blood collection ; however , HR remained elevated significantly during the Recovery phase when blood collection was preceded by the diaper change ( P<0.03 ) . Discussion The BIIP scale is reliable , accurate , and valid assessment for measuring acute pain in preterm infants in the NICU . This assessment combines the relatively most specific , anatomically based , theoretically derived indicators ; and it allows evaluation of behavioral and physiologic pain responses separately OBJECTIVES To examine the construct validity , inter-rater reliability , and feasibility of the Premature Infant Pain Profile-Revised in infants of varying gestational ages , diagnoses , and procedures . METHODS A prospect i ve cross-over study with infants in three gestational age groups ( 26 - 31 , 32 - 36 , and ≥37 weeks ) at three university-affiliated Neonatal Intensive Care Units in Canada . One hundred and ninety five bedside nurses and expert raters rated 202 hospitalized infants ' pain during scheduled procedures using the measure . An expert rater and a nurse independently assessed infants ' pain scores , using the Premature Infant Pain Profile-Revised , during 246 scheduled pairs of painful and non-painful procedures in the 202 infants . Nurses also completed a feasibility survey on using the measure in a clinical setting . To establish construct validity , pain scores were computed during painful and non-painful procedures . Inter-rater reliability between pain experts and nurses was calculated . A 5-point Likert scale was used to measure feasibility in terms of clarity , ease of use , and time to complete . RESULTS Irrespective of gestational age , Premature Infant Pain Profile-Revised scores were significantly higher during painful procedures ( mean 6.7 [ SD 3.0 ] ) compared to non-painful procedures ( mean 4.8 [ SD 2.9 ] ) . There was a high degree of correlation between nurses ' and experts ' ratings for painful ( all R(2)=0.92 , p<0.001 ) and non-painful ( all R(2)=0.87 , p<0.001 ) procedures . Mean scores on all feasibility indicators were equal to or higher than 3.8 . DISCUSSION The Premature Infant Pain Profile Revised has beginning construct validation , inter-rater reliability , and is considered feasible by clinicians . Concurrent validation studies should be considered CONTEXT Effective strategies to improve pain management in neonates require a clear underst and ing of the epidemiology and management of procedural pain . OBJECTIVE To report epidemiological data on neonatal pain collected from a geographically defined region , based on direct bedside observation of neonates . DESIGN , SETTING , AND PATIENTS Between September 2005 and January 2006 , data on all painful and stressful procedures and corresponding analgesic therapy from the first 14 days of admission were prospect ively collected within a 6-week period from 430 neonates admitted to tertiary care centers in the Paris region of France ( 11.3 millions inhabitants ) for the Epidemiology of Procedural Pain in Neonates ( EPIPPAIN ) study . MAIN OUTCOME MEASURE Number of procedures considered painful or stressful by health personnel and corresponding analgesic therapy . RESULTS The mean ( SD ) gestational age and intensive care unit stay were 33.0 ( 4.6 ) weeks and 8.4 ( 4.6 ) calendar days , respectively . Neonates experienced 60,969 first-attempt procedures , with 42,413 ( 69.6 % ) painful and 18,556 ( 30.4 % ) stressful procedures ; 11,546 supplemental attempts were performed during procedures including 10,366 ( 89.8 % ) for painful and 1180 ( 10.2 % ) for stressful procedures . Each neonate experienced a median of 115 ( range , 4 - 613 ) procedures during the study period and 16 ( range , 0 - 62 ) procedures per day of hospitalization . Of these , each neonate experienced a median of 75 ( range , 3 - 364 ) painful procedures during the study period and 10 ( range , 0 - 51 ) painful procedures per day of hospitalization . Of the 42,413 painful procedures , 2.1 % were performed with pharmacological-only therapy ; 18.2 % with nonpharmacological-only interventions , 20.8 % with pharmacological , nonpharmacological , or both types of therapy ; and 79.2 % without specific analgesia , and 34.2 % were performed while the neonate was receiving concurrent analgesic or anesthetic infusions for other reasons . Prematurity , category of procedure , parental presence , surgery , daytime , and day of procedure after the first day of admission were associated with greater use of specific preprocedural analgesia , whereas mechanical ventilation , noninvasive ventilation and administration of nonspecific concurrent analgesia were associated with lower use of specific preprocedural analgesia . CONCLUSION During neonatal intensive care in the Paris region , large numbers of painful and stressful procedures were performed , the majority of which were not accompanied by analgesia BACKGROUND Spinal anesthesia ( SA ) remains the ' gold st and ard ' in neonatal anesthesia for inguinal herniorrhaphy but its short duration impedes its usefulness . We previously demonstrated that clonidine prolongs neonatal SA without immediate side effects . METHODS We conducted a prospect i ve observational study of 124 infants undergoing herniorrhaphy under SA with bupivacaine and clonidine . Two cohorts , term ( n = 57 ) and former preterm ( n = 67 ) infants , were evaluated and compared with regard to episodes of apnea , desaturation , and bradycardia within 24 h of SA . RESULTS In both groups , postoperative desaturation episodes were unchanged after SA , compared with the 12 preoperative hours , despite significantly increased apnea ( P < 0.003 and < 0.011 respectively ) . Transient bradycardias occurred in former preterm infants ( P < 0.014 ) : they spontaneously resolved in all cases . Mean arterial pressure did not vary during the study . Upper sensory level of SA , sedation on entering the postanesthesia care unit ( PACU ) and duration of stay in the PACU were similar in both groups . CONCLUSIONS The clinical significance of short apneas , recovering spontaneously without desaturation , remains debatable . It is concluded that addition of clonidine to neonatal SA results in acceptable side effects . Side effects must be compared with the potential advantages before future recommendations Objectives : To assess the influence of an infusion of clonidine 1 & mgr;g/kg/hr on fentanyl and midazolam requirement in ventilated newborns and infants . Design : Prospect i ve , double-blind , r and omized controlled multicenter trial . Controlled trials.com/IS RCT N77772144 . Setting : Twenty-eight level 3 German PICUs/neonatal ICUs . Patients : Ventilated newborns and infants : stratum I ( 1–28 d ) , stratum II , ( 29–120 d ) , and stratum III ( 121 d to 2 yr ) . Interventions : Patients received clonidine 1 & mgr;g/kg/hr or placebo on day 4 after intubation . Fentanyl and midazolam were adjusted to achieve a defined level of analgesia and sedation according to Hartwig score . Measurements and Main Results : Two hundred nineteen infants were r and omized ; 212 received study medication , 69.7 % were ventilated in the postoperative care and 30.3 % for other reasons . Primary endpoint : consumption of fentanyl and midazolam in the 72 hours following the onset of study medication ( main observation period ) in the overall study population . The confirmatory analysis of the overall population showed no difference in the consumption of fentanyl and midazolam . Explorative age-stratified analysis demonstrated that in stratum I ( n = 112 ) the clonidine group had a significantly lower consumption of fentanyl ( clonidine : 2.1 ± 1.8 & mgr;g/kg/hr , placebo : 3.2 ± 3.1 & mgr;g/kg/hr ; p = 0.032 ) and midazolam ( clonidine : 113.0 ± 100.1 & mgr;g/kg/hr , placebo : 180.2 ± 204.0 & mgr;g/kg/hr ; p = 0.030 ) . Strata II ( n = 43 ) and III ( n = 46 ) showed no statistical difference . Sedation and withdrawal-scores were significantly lower in the clonidine group of stratum I ( p < 0.001 ) . Frequency of severe adverse events did not differ between groups . Conclusions : Clonidine 1 & mgr;g/kg/hr in ventilated newborns reduced fentanyl and midazolam dem and with deeper levels of analgesia and sedation without substantial side effects . This was not demonstrated in older infants , possibly due to lower clonidine serum levels OBJECTIVE Inadequate assessment of pain in premature infants is a persistent clinical problem . The objective of this research was to develop and vali date a measure for assessing pain in premature infants that could be used by both clinicians and research ers . DESIGN The Premature Infant Pain Profile ( PIPP ) was developed and vali date d using a prospect i ve and retrospective design . Indicators of pain were identified from clinical experts and the literature . Indicators were retrospectively tested using four existing data sets . PATIENTS AND SETTING S Infants of varying gestational ages undergoing different painful procedures from three different setting s were utilized to develop and vali date the measure . METHODS AND RESULTS The largest data set ( n = 124 ) was used to develop the PIPP . The development process included determining the factor structure of the data , developing indicators and indicator scales and establishing internal consistency . The remaining three data sets were utilized to establish beginning construct validity . CONCLUSIONS The PIPP is a newly developed pain assessment measure for premature infants with beginning content and construct validity . The practicality and feasibility for using the PIPP in clinical practice will be determined in prospect i ve research in the clinical setting Objective The objectives of this study were to : ( 1 ) evaluate the validity of the Neonatal Facial Coding System ( NFCS ) for assessment of postoperative pain and ( 2 ) explore whether the number of NFCS facial actions could be reduced for assessing postoperative pain . Design Prospect i ve , observational study . Patients Thirty-seven children ( 0–18 months old ) undergoing major abdominal or thoracic surgery . Outcome Measures The outcome measures were the NFCS , COMFORT “ behavior ” scale , and a Visual Analog Scale ( VAS ) , as well as heart rate , blood pressure , and catecholamine and morphine plasma concentrations . At 3-hour intervals during the first 24 hours after surgery , nurses recorded the children 's heart rates and blood pressures and assigned COMFORT “ behavior ” and VAS scores . Simultaneously we videotaped the children 's faces for NFCS coding . Plasma concentrations of catecholamine , morphine , and its metabolite M6 G were determined just after surgery , and at 6 , 12 , and 24 hours postoperatively . Results All 10 NFCS items were combined into a single index of pain . This index was significantly associated with COMFORT “ behavior ” and VAS scores , and with heart rate and blood pressure , but not with catecholamine , morphine , or M6 G plasma concentrations . Multidimensional scaling revealed that brow bulge , eye squeeze , nasolabial furrow , horizontal mouth stretch , and taut tongue could be combined into a reduced measure of pain . The remaining items were not interrelated . This reduced NFCS measure was also significantly associated with COMFORT “ behavior ” and VAS scores , and with heart rate and blood pressure , but not with the catecholamine , morphine , or M6 G plasma concentrations . Conclusion This study demonstrates that the NFCS is a reliable , feasible , and valid tool for assessing postoperative pain . The reduction of the NFCS to 5 items increases the specificity for pain assessment without reducing the sensitivity and validity for detecting changes in pain IMPORTANCE Continuous morphine infusion as st and ard postoperative analgesic therapy in young infants is associated with unwanted adverse effects such as respiratory depression . OBJECTIVE To determine whether intravenous paracetamol ( acetaminophen )
Output:
| We did not find any studies that met our inclusion criteria and hence there is no evidence to recommend or refute the use of clonidine for the prevention or treatment of procedural or postoperative pain , or pain associated with clinical conditions in neonates |
MS213939 | ***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 effect on serum high density lipoprotein subfractions of a low fat diet with a high ratio of polyunsaturated-to-saturated fatty acids was studied in 38 middle-aged volunteers ( 19 men and 19 women ) in North Karelia , Finl and . The mean serum HDL2 cholesterol decreased from 32 + /- 2 mg/dl ( mean + /- SE ) to 28 + /- 2 mg/dl ( p less than 0.001 ) during the experimental diet and returned to 33 + /- 2 mg/dl ( p less than 0.001 ) after a return to the original diet . No changes were observed in the concentration of HDL3 cholesterol . A highly significant decrease was observed in serum apoprotein A-I concentration , but not in apoprotein A-II concentration during the experimental diet . It is concluded that a low-fat , high-P/S ratio diet lowers LDL and HDL2 cholesterol in healthy volunteers , but does not influence the level of HDL3 subfraction The Minnesota Coronary Survey was a 4.5-year , open enrollment , single end-time , double-blind , r and omized clinical trial that was conducted In six Minnesota state mental hospitals and one nursing home . It Involved 4393 Institutionalized men and 4664 Institutionalized women . The trial compared the effects of a 39 % fat control diet ( 18 % saturated fat , 5 % polyunsaturated fat , 16 % monounsaturated fat , 446 mg dietary cholesterol per day ) with a 38 % fat treatment diet ( 9 % saturated fat , 15 % polyunsaturated fat , 14 % monounsaturated fat , 166 mg dietary cholesterol per day ) on serum cholesterol levels and the Incidence of myocardlal Infa rct ions , sudden deaths , and all-cause mortality . The mean duration of time on the diets was 384 days , with 1568 subjects consuming the diet for over 2 years . The mean serum cholesterol level In the pre-admission period was 207 mg/dl , falling to 175 mg/dl in the treatment group and 203 mg/dl In the control group . For the entire study population , no differences between the treatment and control groups were observed for cardiovascular events , cardiovascular deaths , or total mortality . A favorable trend for all these end-points occurred In some younger age groups It has been suggested that alpha-tocopherol , a safe and effective antioxidant , be used in clinical trials to evaluate the ability of antioxidant therapy to inhibit atherosclerosis . Recent reports , however , have raised the possibility that there may be greater enrichment of plasma low density lipoprotein ( LDL ) in alpha-tocopherol result ing from the use of the naturally occurring RRR-alpha-tocopherol isomer compared with the other isomers present in the synthetic racemic form of alpha-tocopherol . Therefore , we fed equal dosages ( 1,600 mg/day ) of the two forms of vitamin E to 16 men and women for 8 weeks and compared the effects of this supplementation on the susceptibility of isolated lipoproteins to oxidation . Neither form of vitamin E had appreciable effects on lipid or lipoprotein levels . alpha-Tocopherol levels in LDL increased at a similar rate in both groups and were nearly twofold higher than baseline levels by the end of the study . The susceptibility of LDL to oxidation was measured by formation of conjugated dienes , lipid peroxides , and thiobarbituric acid-reactive substances , as well as by macrophage degradation of LDL exposed to oxidizing conditions in vitro . The susceptibility of LDL to oxidation was decreased in both vitamin E groups compared with the baseline value , and this reduction occurred to a similar extent in both vitamin E-supplemented groups . alpha-Tocopherol levels in LDL also strongly correlated with all measures of LDL oxidation . This study demonstrates that , at this dosage , supplementation with either the natural or synthetic form of alpha-tocopherol provided equal antioxidant protection to LDL The effects of high oleic acid rapeseed oil compared with polyunsaturated fats on serum lipoprotein levels are largely unknown . Therefore , we fed 30 women and 29 men a baseline diet rich in saturated fat , which was followed by a diet rich in high oleic and low erucic acid rapeseed oil ( total energy content of fat , 38 % ; saturates , 12.4 % ; monounsaturates , 16 % ; n-6 polyunsaturates , 6 % ; and n-3 polyunsaturates , 2 % ) and one rich in sunflower oil ( total energy content of fat , 38 % ; saturates , 12.7 % ; monounsaturates , 10 % ; n-6 polyunsaturates , 13 % ; and n-3 polyunsaturates , 0 % ) . The oils were incorporated into mixed natural diets that were dispensed in a r and om order for 3.5 weeks each in a blinded crossover design . The diet composition was confirmed by analysis of duplicate diets . Both test diets reduced serum total cholesterol ( TC ) and low density lipoprotein ( LDL ) cholesterol levels from baseline , the monounsaturated rapeseed oil diet more than the polyunsaturated sunflower oil diet ( TC : -15 % versus -12 % , p less than 0.01 ; LDL cholesterol : -23 % versus -17 % , p less than 0.01 ) . Very low density lipoprotein ( VLDL ) cholesterol and total , VLDL , and LDL triglyceride levels were lower during the sunflower oil diet compared with the rapeseed oil diet . Total high density lipoprotein ( HDL ) cholesterol levels remained unchanged by both diets . The consumption of rapeseed oil result ed in a more favorable HDL2 to LDL cholesterol ratio ( 0.43 + /- 0.19 versus 0.39 + /- 0.18 , p less than 0.01 ) and an apolipoprotein A-I to B ratio ( 3.0 + /- 1.4 versus 2.4 + /- 1.6 , p less than 0.001 ) than did the sunflower oil . ( ABSTRACT TRUNCATED AT 250 WORDS This report describes the effects of feeding linoleate- or oleate-enriched diets to subjects who were concurrently taking 1200 mg/d of alpha-tocopherol on the susceptibility of low-density lipoprotein ( LDL ) and buoyant and dense LDL subfractions to oxidation . LDL isolated from subjects who consumed linoleate-enriched diets was more susceptible to copper-mediated oxidation , as measured by formation of conjugated dienes and lipid peroxides and loss of unsaturated fatty acids , compared with LDL isolated from subjects who consumed their usual or oleate-enriched diets . In all subjects , buoyant LDL had a higher content of alpha-tocopherol per particle and a lower 18:2 to 18:1 ratio and was considerably more resistant to oxidation than dense LDL . Although dense LDL from all groups had comparable alpha-tocopherol levels , dense LDL from the linoleate group was most susceptible to oxidation , followed by that from the st and ard diet , whereas dense LDL isolated from the oleate diet group was most resistant . In summary , high dosages of alpha-tocopherol did not prevent enhanced susceptibility to oxidation of LDL isolated from subjects fed linoleate-enriched diets . Furthermore , dense LDL was more susceptible to oxidation than was buoyant LDL , and this effect was greatly exaggerated in the dense LDL isolated from subjects fed linoleate-enriched diets . Conversely , dense LDL isolated from subjects fed oleate-enriched diets was the most protected . If oxidation of LDL is important in the pathogenesis of atherosclerosis , then these data suggest that in people with increased amounts of small , dense LDL , dietary enrichment in oleic acid may decrease the susceptibility of their LDL to oxidation Effects of small amounts of sitosterol , sitostanol and sitostanol esters ( < 1 g/day of free sterols ) dissolved in rapeseed oil ( RSO ) were studied on serum lipids and cholesterol metabolism in patients with primary hypercholesterolemia and different apolipoprotein E phenotypes on an RSO diet . One of the four groups was an RSO-fed control . Serum total and LDL cholesterol reductions were small in different plant sterol-fed groups , tended to be highest in the sitostanol ester group ( -7 % ) , but were significantly reduced by about 5 % in the combined plant sterol groups . The reductions were -8 % in the subjects with epsilon 4 allele and insignificant in those with apo E3/3 phenotype . Cholesterol precursor sterols in serum , markers of cholesterol synthesis , were increased only in the subjects with epsilon 4 allele . Cholesterol absorption was reduced by 7 % , being 31 % in the subjects with epsilon 4 allele , and fecal elimination of cholesterol was increased , a finding also indicating increased cholesterol synthesis . The changes in cholesterol absorption were related to those in fecal plant sterols ( change in dietary intake ) and serum total and LDL cholesterol ( P = 0.04 , 0.01 and 0.05 , respectively ) . Thus , small amounts of dietary plant sterols ( < 1 g/day ) , especially sitostanol esters dissolved in dietary fats , decrease serum total and LDL cholesterol by a proportional decrease in cholesterol absorption which , in turn , is associated with a compensatory increase in cholesterol synthesis . The effects are most consistent in subjects with epsilon 4 allele , but for effective hypocholesterolemic treatment dietary amount of sitostanol ester should exceed 1 g/day Background Do the benefits of intensive lipid-lowering therapy seen in symptomatic patients extend to high-risk subjects who have never had symptoms ? Methods and ResulsOf 120 men completing the FATS trial , 91 were symptomatic and 29 asymptomatic . All had apolipoprotein B 2125 mg/dL , a positive family history , and coronary atherosclerosis . All were counseled in diet and r and omized to intensive therapy : colestipol 10 g TID plus either niacin 1 g QID or lovastatin 20 mg BID or to conventional therapy : placebos , or colestipol if low-density lipoprotein cholesterol was elevated . End points included quantitative arteriographic disease change and clinical events over a 2.5-year interval . At baseline , symptomatic and asymptomatic patients had comparable risk profiles , but proximal stenosis severity averaged 36 % for symptomatic and 23 % for asymptomatic patients ( P<.001 ) . Among the 91 symptomatic patients , those in the intensive group experienced definite ( .101%S ) proximal lesion progression less frequently than conventional ( 24 % of intensive versus 48 % of conventional ) and definite regression more frequently ( 36 % of intensive versus 15 % of conventional ) ( P=.009 ) . Similarly , among the 29 asymptomatic patients , 19 % of intensive versus 38 % of conventional had progression and 31 % of intensive versus 0%1 of conventional , regression ( P=.04 ) . Ischemia on baseline exercise tolerance testing was associated with significantly greater proximal disease progression among the asymptomatic patients . Clinical cardiovascular events ( death , infa rct ion , or revascularization ) occurred in 10 of 38 symptomatic patients originally assigned to conventional therapy , compared with 5 of 76 symptomatic patients assigned to intensive ( P<.01 ) ; no asymptomatic patient had an event . ConcluionsAsymptomatic subjects with this high-risk profile have less coronary disease at baseline than comparable symptomatic patients , and they have an excellent short-term clinical prognosis . However , asymptomatic subjects are indistinguishable from symptomatic patients in terms of their arterial disease progression with conventional therapy and their regression with intensive . These findings may justify an active treatment strategy in such subjects , particularly those with provokable ischemia The primary aim of this study was to estimate the relation between cholesterol reduction and total mortality and coronary heart disease ( CHD ) incidence . Secondarily , the clinical issues of whether the efficacy of cholesterol lowering is dependent on the treatment modality , presence of CHD at baseline , or the simultaneous introduction of other interventions was explored . All r and omized clinical intervention trials of cholesterol reduction were used in an overview analysis of total mortality rate and CHD incidence ; analysis was performed with weighted linear regression . The trials include those that used primary and secondary intervention , diet and drugs , and single or multifactor design . Nineteen trials were analyzed for total mortality , and of the 19 , 16 were analyzed for CHD incidence rate . Net difference in cholesterol change between study groups was used as the independent variable , and the three previously mentioned dichotomous design characteristics were used as additional independent variables . For every 1 % reduction in cholesterol , an estimated 2.5 % reduction in CHD incidence is indicated ( 95 % CL : 1.1 , 3.9 ) . With regard to CHD drug trials tended toward better efficiency in cholesterol lowering than did dietary trials .
Output:
| No significant difference was noted for the majority of secondary outcomes for any of the planned comparisons . |
MS213940 | ***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 studied 52 adults undergoing elective craniotomy , allocated r and omly to one of three opioid treatments : alfentanil 50 micrograms kg-1 followed by 0.833 microgram kg-1 min-1 until dural closure ( group Alf . ) ; alfentanil 50 micrograms kg-1 followed by 0.833 microgram kg-1 min-1 for 2 h , then remifentanil 0.25 microgram kg-1 min-1 ( group Alf.-Remi . ) ; or remifentanil 1 microgram kg-1 followed by 0.5 microgram kg-1 min-1 reducing to 0.25 microgram kg-1 min-1 after craniotomy ( group Remi . ) . Anaesthesia was maintained with infusion of propofol and 66 % nitrous oxide in oxygen . Infusions of propofol and remifentanil were stopped at head b and aging . Group Remi . had the least intraoperative haemodynamic responses and group Alf . the most ( P < 0.05 ) . Times to tracheal extubation and obey comm and s were similar in all groups . In all patients in group Alf.-Remi . and group Remi . , the trachea was extubated 27 min from the end of anaesthesia ; three patients in group Alf . were slower to recover . Use of analgesia in the recovery room and time to transfer to the neurosurgical unit were similar in the three groups OBJECTIVE Large bolus-dose remifentanil may be advantageous for use during induction of anesthesia because of its short duration of effect . Currently , there are little data on the use of large bolus-dose remifentanil because of reports of severe bradycardia and hypotension . The purpose of this study is to compare the hemodynamic effects of bolus remifentanil versus fentanyl with glycopyrrolate for induction of anesthesia in patients with heart disease . DESIGN A r and omized , double-blinded study . SETTING A tertiary-care academic medical center . PARTICIPANTS One hundred patients for coronary artery bypass or valvular surgery . INTERVENTION Subjects received either ( 1 ) remifentanil , 5 microg/kg , with glycopyrrolate , 0.2 mg , or ( 2 ) fentanyl , 20 microg/kg , with 0.2 mg of glycopyrrolate , and both groups also received midazolam , 70 microg/kg , for induction of anesthesia . MEASUREMENTS AND MAIN RESULTS Heart rate , mean arterial pressure , systemic vascular resistance , and cardiac output were similar between the 2 groups during induction of anesthesia and tracheal intubation . The incidence of adverse events such as bradycardia ( remifentanil 10 % , fentanyl 10 % ) , hypotension ( remifentanil 16 % , fentanyl 10 % ) , and ischemia ( remifentanil 0 % , fentanyl 2 % ) were also similar . A greater percentage of patients in the remifentanil group lost consciousness within 1 minute of opioid administration ( 86 % v 66 % , p = 0.034 ) . CONCLUSION Remifentanil with glycopyrrolate is associated with rapid and predictable clinical anesthetic effect , cardiac stability , and the ability to blunt the hemodynamic responses to tracheal intubation . Bolus remifentanil may be a feasible alternative to bolus fentanyl for induction of anesthesia in patients with heart disease because of its short duration of action and its ability to blunt the hemodynamic responses to tracheal intubation The purpose of this study was to test the hypothesis that using a 1:4 ratio of remifentanil to alfentanil , a remifentanil infusion would provide better suppression of intraoperative responses and comparable recovery profiles after ambulatory laparoscopic surgery than an alfentanil infusion , as part of total intravenous anesthesia . Two hundred ASA physical status I , II , or III adult patients participated in this multicenter , double-blind , parallel group study . Patients were r and omly assigned 2:1 to either the remifentanil-propofol or alfentanil-propofol regimens . The anesthesia sequence was propofol ( 2 mg/kg intravenously [ IV ] followed by 150 micro g [ centered dot ] kg ( -1 ) [ centered dot ] min-1 ) , and either remifentanil ( 1 micro g/kg IV followed by 0.5 micro g [ centered dot ] kg-1 [ centered dot ] min-1 ) or alfentanil ( 20 micro g/kg IV followed by 2 micro g [ centered dot ] kg-1 [ centered dot ] min ( -1 ) ) , and vecuronium . After trocar insertion , infusion rates were decreased ( propofol to 75 micro g [ centered dot ] kg-1 [ centered dot ] min-1 ; remifentanil to 0.25 micro g [ centered dot ] kg-1 [ centered dot ] min-1 ; alfentanil to 1 micro g [ centered dot ] kg-1 [ centered dot ] min-1 ) . Alfentanil and propofol were discontinued at 10 and 5 min , respectively , before the anticipated end of surgery ( last surgical suture ) ; remifentanil was discontinued at the end of surgery . Recovery times were calculated from the end of surgery . The median duration of surgery was similar between groups ( 39 min for remifentanil versus 34 min for alfentanil ) . A smaller proportion of remifentanil patients than alfentanil patients had any intraoperative responses ( 53 % vs 71 % , P = 0.029 ) , had responses to trocar insertion ( 11 % vs 32 % , P < 0.001 ) , or required dosage adjustments during maintenance ( 24 % vs 41 % , P < 0.05 ) . Early awakening times were similar . Remifentanil patients qualified for Phase 1 discharge later and were given postoperative analgesics sooner than alfentanil patients ( P < 0.05 ) . Actual discharge times from the ambulatory center were similar between groups ( 174 min for remifentanil versus 204 min for alfentanil ) ( P = 0.06 ) . In conclusion , remifentanil can be used for maintenance of anesthesia in a 1:4 ratio compared with alfentanil , for total IV anesthesia in ambulatory surgery . This dose of remifentanil provides more effective suppression of intraoperative responses and does not result in prolonged awakening . ( Anesth Analg 1997;84:515 - 21 INTRODUCTION The aim of this study was to investigate how many patients , after anesthesia with either propofol/remifentanil or propofol/fentanyl/alfentanil , within 20 minutes from the end of surgery could be transferred directly to the general ward . The number of undesired preoperative incidents , the anesthetists ' , the surgeons ' , and the patients ' evaluations of the anesthesia were registered . An evaluation of the economic consequences of the two methods was also intended . MATERIAL AND METHODS The study was clinical ly controlled , r and omised , and partly blinded . A total of 80 patients undergoing eye surgery were recruited . The patients were scored 10 , 15 , and 20 minutes after the end of surgery according to a modified Aldrete score . With sufficient awakening score , the patients were transferred to the general ward . RESULTS Thirty-six patients in each group underwent the examination . In the propofol/remifentanil-group 31 ( 86 % ) could be transferred to the general ward compared to 15 ( 42 % ) in the proponol/fentanyl/alfentanil-group . In the propofol/remifentanil-group there were less reactions to the start of surgery , more episodes with preoperative hypotension and postoperative shivering . Otherwise there were no differences between the groups . It was estimated that the additional expenses for medcine were by far outweighed by the lower costs postoperatively . DISCUSSION With a propofol/remifentanil-anesthesia , the patients had a predictably short awakening time , so they could be transferred directly to the general ward . This may , especially in ambulatory surgery , mean cost savings and perhaps higher patient satisfaction We compared a fentanyl/isoflurane/propofol regimen with a remifentanil/isoflurane/propofol regimen for fast-track cardiac anesthesia in a prospect i ve , r and omized , double-blinded study on patients undergoing elective coronary artery bypass graft surgery . Anesthesia was induced with a 1-min infusion of 0.5 mg/kg propofol followed by 10-mg boluses of propofol every 30 s until loss of consciousness . After 0.2 mg/kg cisatracurium , a blinded continuous infusion of remifentanil at 1 & mgr;g · kg−1 · min−1 or the equivalent volume rate of normal saline was then started . In addition , a blinded bolus syringe of 1 & mgr;g/kg remifentanil or 10 & mgr;g/kg fentanyl , respectively , was given over 3 min . Blinded remifentanil , 1 & mgr;g · kg−1 · min−1 ( or the equivalent volume rate of normal saline ) , together with 0.5 % isoflurane , were used to maintain anesthesia . Significantly more patients ( P < 0.01 ) in the fentanyl regimen experienced hypertension during skin incision and maximum sternal spread compared with patients in the remifentanil regimen . There were no differences between the groups in time until extubation , discharge from the surgical intensive care unit , ST segment and other electrocardiogram changes , catecholamine levels , or cardiac enzymes . The remifentanil-based anesthetic ( consisting of a bolus followed by a continuous infusion ) result ed in significantly less response to surgical stimulation and less need for anesthetic interventions compared with the fentanyl regimen ( consisting of an initial bolus , and followed by subsequent boluses only to treat hemodynamic responses ) with both drug regimens allowing early extubation STUDY OBJECTIVES To compare the intraoperative effects and recovery characteristics of remifentanil hydrochloride and alfentanil when administered as part of balanced anesthesia , and to assess the effects of an additional remifentanil infusion administered as analgesic pretreatment before removal of the uterus . DESIGN Multicenter , double-blind , r and omized , parallel-group study . SETTING Two university hospitals . PATIENTS 35 ASA physical status I , II , and III women scheduled for elective total abdominal hysterectomy with general endotracheal anesthesia . INTERVENTIONS Patients were premedicated with midazolam 0.05 mg/kg intravenously ( i.v . ) . Anesthesia was induced with thiopental 2 mg/kg , vecuronium 0.15 mg/kg , and a single dose of opioid over 60 seconds ( Pump 1 ) : remifentanil 2 micrograms/kg ( Remi/Placebo and Remi/Remi groups ) or alfentanil 50 micrograms/kg ( Alf/Placebo group ) . Anesthesia was maintained with a nitrous oxide/oxygen mixture ( 66:34 ratio ) and a continuous opioid infusion : remifentanil 0.25 microgram/kg/min ( Remi/Placebo and Remi/Remi ) or alfentanil 0.5 microgram/kg/min ( Alf/Placebo ) . At skin incision , a second blinded drug infusion was also initiated ( Pump 2 ) : remifentanil 0.25 microgram/kg/min ( Remi/Remi ) or saline placebo ( Remi/Placebo and Alf/Placebo ) . Intraoperative responses were controlled with single doses of opioid and /or rate titrations via Pump 1 . Pump 2 was terminated on removal of the uterus . Pump 1 was terminated at skin closure . MEASUREMENTS AND MAIN RESULTS The mean ( + /- SD ) opioid infusion rates administered for the duration of Pump 2 to suppress responses to removal of the uterus were 0.49 + /- 0.27 microgram/kg/min , 1.99 + /- 1.34 micrograms/kg/min , and 0.49 + /- 0.07 microgram/kg/min for the Remi/Placebo , Alf/Placebo , and Remi/Remi groups , respectively . At these rates , similar proportions of patients in the Remi/Placebo ( 67 % ) and the Alf/Placebo ( 60 % ) groups had responses . Fewer patients had responses in the Remi/Remi group ( 8 % ) compared with the Remi/Placebo and Alf/Placebo groups ( p < 0.05 ) . The mean total opioid doses used during maintenance were 84.6 micrograms/kg ( Remi/Placebo ) , 393 micrograms/kg ( Alf/Placebo ) , and 68.7 micrograms/kg ( Remi/Remi ) . Awakening times were significantly shorter ( p < 0.05 ) in the remifentanil population compared with the alfentanil population , but discharge times were similar . More patients received naloxone to reverse opioid effects in the alfentanil population ( 60 % ) than in the remifentanil population ( 20 % ) ( p < 0.0
Output:
| Remifentanil does not seem to offer any advantage for lengthy , major interventions , but may be useful for selected patients , e.g. when postoperative respiratory depression is a concern |
MS213941 | ***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 The aim of this study was to investigate the effect of low-level laser therapy ( LLLT ) on reducing post-adjustment orthodontic pain via evaluation of gingival crevicular fluid ( GCF ) composition changes at the level of prostagl and in-E(2 ) ( PGE(2 ) ) and visual analogue scale ( VAS ) . BACKGROUND DATA LLLT has been found to be effective in pain relief . PGE(2 ) has the greatest impact on the process of pain signals and can be detected in GCF in order to investigate the response of dental and periodontal tissues in a biochemical manner . MATERIAL S AND METHODS Nineteen patients ( 11 females and 8 males ; mean age 13.9 years ) were included in this study . Maxillary first molars were b and ed and then a r and omly selected first molar at one side was irradiated ( λ820 nm ; continuous wave ; output power : 50 mW ; focal spot : 0.0314 cm(2 ) ; exposure duration : 5 sec ; power density : 1.59 W/cm(2 ) ; energy dose : 0.25 J ; energy density : 7.96 J/cm(2 ) for each shot ) , while the molar at the other side was served as placebo control . The GCF was collected from the gingival crevice of each molar to evaluate PGE(2 ) levels , before b and placement , 1 and 24 h after laser irradiation . Pain intensity was analyzed at 5 min , 1 h , and 24 h after b and placement by using VAS . RESULTS Although no difference was found in pain perception at 5 min and 1 h , significant reduction was observed with laser treatment 24 h after application ( p<0.05 ) . The mean PGE(2 ) levels were significantly elevated in control group , whereas a gradual decrease occurred in laser group . The difference in PGE(2 ) levels at both 1 and 24 h were statistically significant between two groups ( p<0.05 ) . CONCLUSIONS The significant reductions in both pain intensity and PGE(2 ) levels revealed that LLLT was efficient in reducing orthodontic post-adjustment pain Background : Low level laser therapy ( LLLT ) has gained increasing popularity in the management of tendinopathy and arthritis . Results from in vitro and in vivo studies have suggested that inflammatory modulation is one of several possible biological mechanisms of LLLT action . Objective : To investigate in situ if LLLT has an anti-inflammatory effect on activated tendinitis of the human Achilles tendon . Subjects : Seven patients with bilateral Achilles tendinitis ( 14 tendons ) who had aggravated symptoms produced by pain inducing activity immediately before the study . Method : Infrared ( 904 nm wavelength ) LLLT ( 5.4 J per point , power density 20 mW/cm2 ) and placebo LLLT ( 0 J ) were administered to both Achilles tendons in r and om blinded order . Results : Ultrasonography Doppler measurements at baseline showed minor inflammation through increased intratendinous blood flow in all 14 tendons and measurable resistive index in eight tendons of 0.91 ( 95 % confidence interval 0.87 to 0.95 ) . Prostagl and in E2 concentrations were significantly reduced 75 , 90 , and 105 minutes after active LLLT compared with concentrations before treatment ( p = 0.026 ) and after placebo LLLT ( p = 0.009 ) . Pressure pain threshold had increased significantly ( p = 0.012 ) after active LLLT compared with placebo LLLT : the mean difference in the change between the groups was 0.40 kg/cm2 ( 95 % confidence interval 0.10 to 0.70 ) . Conclusion : LLLT at a dose of 5.4 J per point can reduce inflammation and pain in activated Achilles tendinitis . LLLT may therefore have potential in the management of diseases with an inflammatory component OBJECTIVE To analyze the effect of low-level laser therapy ( LLLT ) on perception of pain after separator placement and compare it with perceptions of control and placebo groups using a frequent irradiation protocol . MATERIAL S AND METHODS Eighty-eight patients were r and omly allocated to a laser group , a light-emitting diode ( LED ) placebo group , or a control group . Elastomeric separators were placed on the first molars . In the laser and LED groups , first molars were irradiated for 30 seconds every 12 hours for 1 week using a portable device . Pain was marked on a visual analog scale at predetermined intervals . Repeated measure analysis of variance was performed for statistical analysis . RESULTS The pain scores of the laser group were significantly lower than those of the control group up to 1 day . The pain scores in the LED group were not significantly different from those of the laser group during the first 6 hours . After that point , the pain scores of the LED group were not significantly different from those of the control . CONCLUSIONS Frequent LLLT decreased the perception of pain to a nonsignificant level throughout the week after separator placement , compared with pain perception in the placebo and control groups . Therefore , LLLT might be an effective method of reducing orthodontic pain INTRODUCTION The purpose of this study was to clinical ly evaluate the effect of low-level laser therapy ( LLLT ) as a method of reducing pain reported by patients after placement of their first orthodontic archwires . METHODS The sample comprised 60 orthodontic patients ( ages , 12 - 18 years ; mean , 15.9 years ) . All patients had fixed orthodontic appliances placed in 1 dental arch ( maxillary or m and ibular ) , received the first archwire , and were then r and omly assigned to the experimental ( laser ) , placebo , or control group . This was a double-blind study . LLLT was started in the experimental group immediately after placement of the first archwire . Each tooth received a dose of 2.5 J per square centimeter on each side ( buccal and lingual ) . The placebo group had the laser probe positioned into the mouth at the same areas overlying the dental root and could hear a sound every 10 seconds . The control group had no laser intervention . All patients received a survey to be filled out at home describing their pain during the next 7 days . RESULTS The patients in the LLLT group had lower mean scores for oral pain and intensity of pain on the most painful day . Also , their pain ended sooner . LLLT did not affect the start of pain perception or alter the most painful day . There was no significant difference in pain symptomatology in the maxillary or m and ibular arches in an evaluated parameter . CONCLUSIONS Based on these findings , we concluded that LLLT efficiently controls pain caused by the first archwire OBJECTIVE To test the hypothesis that there is no difference in the pain associated with orthodontic force application after the application of local CO(2 ) laser irradiation to the teeth involved . MATERIAL S AND METHODS Separation modules were placed at the distal contacts of the maxillary first molars in 90 patients in this single-blinded study . In 60 of these patients ( 42 females and 18 males ; mean age = 19.22 years ) this was immediately followed by laser therapy . The other 30 patients ( 18 females and 12 males ; mean age = 18.8 years ) did not receive active laser irradiation . Patients were then instructed to rate their levels of pain on a visual analog scale over time , and the amount of tooth movement was analyzed . RESULTS Significant pain reductions were observed with laser treatment from immediately after insertion of separators through day 4 , but no differences from the nonirradiated control side were noted thereafter . No significant difference was noted in the amount of tooth movement between the irradiated and nonirradiated group . CONCLUSIONS The hypothesis was rejected . The results suggest that local CO(2 ) laser irradiation will reduce pain associated with orthodontic force application without interfering with the tooth movement The aim of this study was to evaluate the pain sensation that orthodontic patients experience when elastic separators are placed between molars and premolars and to determine the degree of analgesic efficacy of low-level laser therapy ( LLLT ) compared to a placebo treatment . The study was conducted with 20 volunteers who were fitted with elastic separators between the maxillary molars and premolars . One quadrant was r and omly chosen to be irradiated with an 830-nm laser , 100 mW , beam diameter of 7 mm , 250 mW/cm2 applied for 20 s per point ( 5 J/cm2 ) . Three points were irradiated in the buccal face and three were irradiated in the palate . The same procedure was applied in the contralateral quadrant with a placebo light . A visual analogue scale was used to assess pain 5 min , 6 h , 24 h , 48 h , and 72 h after placement of the separators . Maximum pain occurred 6–24 h after placement of the elastic separators . Pain intensity was significantly lower in the laser-treated quadrant ( mean , 7.7 mm ) than in the placebo-treated quadrant ( mean , 14.14 mm ; p = 0.0001 ) . LLLT at these parameters can reduce pain in patients following placement of orthodontic rubber separators Phototherapy with low-level coherent light ( laser ) has been reported as an analgesic and anti-inflammatory as well as having a positive effect in tissue repair in orthodontics . However , there are few clinical studies using low-level LED therapy ( non-coherent light ) . The aim of the present study was to analyze the pain symptoms after orthodontic tooth movement associated with and not associated with coherent and non-coherent phototherapy . Fifty-five volunteers ( mean age = 24.1 ± 8.1 years ) were r and omly divided into four groups : G1 ( control ) , G2 ( placebo ) , G3 ( protocol 1 : laser , InGaAlP , 660 nm , 4 J/cm2 , 0.03 W , 25 s ) , G4 ( protocol 2 : LED , GaAlAs , 640 nm with 40 nm full-b and width at half-maximum , 4 J/cm2 , 0.10 W , 70 s ) . Separators were used to induce orthodontic pain and the volunteers pain levels were scored with the visual analog scale ( VAS ) after the separator placement , after the therapy ( placebo , laser , or LED ) , and after 2 , 24 , 48 , 72 , 96 , and 120 h. The laser group did not have statistically significant results in the reduction of pain level compared to the LED group . The LED group had a significant reduction in pain levels between 2 and 120 h compared to the control and the laser groups . The LED therapy showed a significant reduction in pain sensitivity ( an average of 56 % ) , after the orthodontic tooth movement when compared to the control group OBJECTIVE The purpose of this study was to evaluate the efficacy of GaAlAs laser light to reduce pain induced by post-adjustment orthodontic final archwire , compared with a placebo control group , and also to evaluate if there are differences in pain gradient when conventional brackets or self-ligating brackets are used for orthodontic treatment . BACKGROUND DATA Previous reports indicate that laser therapy is a safe and efficient alternative to alleviate pain caused in the initial stages of treatment , but there are no studies about its efficacy during the last stages of orthodontic treatment . METHODS The initial sample was 60 orthodontic patients from a private practice , treated by straight wire technique , 30 of them with mini brackets Equilibrium ( ® ) ( Dentaurum , Ispringen , Germany ) and 30 with self-ligation In-Ovation C ( ® ) ( GAC/Dentsply , Tokyo , Japan ) slot 0.022 inch brackets . The archwires used in the final stage of orthodontic treatment were stainless steel 0.019 × 0.025 inch , slot 0.022 inch in both groups . In a design of divided mouth , the dental arches were r and omly assigned to receive one dental arch irradiation with 830 nm 100mW therapeutic laser ( Photon Lase II ) , for 22 sec ( 2.2 J , 80 J/cm(2 ) ) along the vestibular surface and 22 sec ( 2.2 J , 80 J/cm(2 ) ) along the palatal surface of the root in the r and omly selected arch . The opposite dental arch received placebo treatment , with the laser light off . Pain was evaluated using a visual analog scale ( VAS ) after 2 , 6 , and 24 h , and 2 , 3 , and 7 days of application . RESULTS The time course of pain showed the same tendency in both groups , reaching a peak 24 h after the archwire activation . The application of laser therapy reduced pain for any period of time up to 7 days ( p<0.00001 ) and for any kind of bracket . CONCLUSIONS Low intensity laser application reduces pain induced by archwires used during the final stage of orthodontic treatment , without any interference regarding the kind of bracket , as reported by patients OBJECTIVE The objective of this study was to evaluate the effectiveness of the use of irradiation with a low-level laser therapy ( LLLT ) , wavelength 830 nm , for treating pain inherent to tooth movement caused by orthodontic devices , simulated by positioning interdental elastomeric separators . METHODS Sixty orthodontic patients were r and omly assigned to two groups : GA ( ages 12 - 25 years ; mean 17.1 years ) was the control , and GB ( ages 12 - 26 years ; mean 17.
Output:
| The selected studies reported promising results for LLLT ; elevated acceleration of tooth movement and lower pain scores , than controls .
With respect to method , there were wide variations in type of laser techniques .
The results highlight the need for high quality research , with consistency in study design , to determine whether LLLT can enhance fixed appliance treatment in children and young adults |
MS213942 | ***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: CONTEXT : Although cognitive aspects of meditation underlie much of its clinical application , very little research has examined meditation 's cognitive consequences . This investigation provides experimental support for the idea that meditation leads to a reduction in habitual responding using r and omly selected subjects , a secular form of meditation , and a full experimental design . OBJECTIVE : To test the hypothesis that meditation leads to a reduction in habitual responding . DESIGN : Studies 1 and 2 each incorporated pre-test and post-test design s with a 20-minute intervening attention task ( meditation , rest , or a cognitive control ) . SETTING : Yale University in New Haven , Conn , and the University of California , Berkeley . PARTICIPANTS : One hundred and twenty and 90 undergraduates participated in Studies 1 and 2 , respectively . MAIN OUTCOME MEASURES : Stroop and Word Production ( category generation and stem-completion ) tasks assessed habitual responding in Study 1 . Galvanic Skin response measured arousal in Study 1 . The category generation task assessed habitual responding in Study 2 . Tellegen 's Absorption Scale ( TAS ) measured attention ability . RESULTS : In Study 1 , meditation participants showed a reduction in habitual responding on the Stroop task as compared to controls . Study 1 revealed no statistically significant effects in the word production task . Stroop task performance was not mediated by arousal reduction . In Study 2 , meditation participants showed a reduction in habitual responding on the category production task . Specifically , when participants generated either typical or atypical items , on average , meditation participants produced more atypical items than controls . Category production performance was not mediated by Tellegen 's Absorption Scale ( TAS ) scores . Overall , high TAS scores were related to atypical responding . CONCLUSION : Across cognitive tasks , when participants understood that the goal was to respond non-habitually , meditation reduced habitual responding BACKGROUND Individuals with a history of recurrent depression have a high risk of repeated depressive relapse or recurrence . Maintenance antidepressants for at least 2 years is the current recommended treatment , but many individuals are interested in alternatives to medication . Mindfulness-based cognitive therapy ( MBCT ) has been shown to reduce risk of relapse or recurrence compared with usual care , but has not yet been compared with maintenance antidepressant treatment in a definitive trial . We aim ed to see whether MBCT with support to taper or discontinue antidepressant treatment ( MBCT-TS ) was superior to maintenance antidepressants for prevention of depressive relapse or recurrence over 24 months . METHODS In this single-blind , parallel , group r and omised controlled trial ( PREVENT ) , we recruited adult patients with three or more previous major depressive episodes and on a therapeutic dose of maintenance antidepressants , from primary care general practice s in urban and rural setting s in the UK . Participants were r and omly assigned to either MBCT-TS or maintenance antidepressants ( in a 1:1 ratio ) with a computer-generated r and om number sequence with stratification by centre and symptomatic status . Participants were aware of treatment allocation and research assessors were masked to treatment allocation . The primary outcome was time to relapse or recurrence of depression , with patients followed up at five separate intervals during the 24-month study period . The primary analysis was based on the principle of intention to treat . The trial is registered with Current Controlled Trials , IS RCT N26666654 . FINDINGS Between March 23 , 2010 , and Oct 21 , 2011 , we assessed 2188 participants for eligibility and recruited 424 patients from 95 general practice s. 212 patients were r and omly assigned to MBCT-TS and 212 to maintenance antidepressants . The time to relapse or recurrence of depression did not differ between MBCT-TS and maintenance antidepressants over 24 months ( hazard ratio 0·89 , 95 % CI 0·67 - 1·18 ; p=0·43 ) , nor did the number of serious adverse events . Five adverse events were reported , including two deaths , in each of the MBCT-TS and maintenance antidepressants groups . No adverse events were attributable to the interventions or the trial . INTERPRETATION We found no evidence that MBCT-TS is superior to maintenance antidepressant treatment for the prevention of depressive relapse in individuals at risk for depressive relapse or recurrence . Both treatments were associated with enduring positive outcomes in terms of relapse or recurrence , residual depressive symptoms , and quality of life . FUNDING National Institute for Health Research ( NIHR ) Health Technology Assessment ( HTA ) programme , and NIHR Collaboration for Leadership in Applied Health Research and Care South West Peninsula Rationale An involvement of 5-HT1A receptors is postulated in the pathophysiology of affective disorders and mechanism of action of antidepressants . Methods for study ing their functional integrity in humans are , however , limited . Preliminary data suggests that activation of somatodendritic 5-HT1A receptors cause a negative shift in the EEG frequency spectrum . Animal research suggests that pindolol is an agonist at these receptors but an antagonist at postsynaptic 5-HT1A receptors . Objective We postulated that while pindolol would antagonise known postsynaptic mediated neuroendocrine responses to the 5-HT1A agonist buspirone , both drugs would have a similar effect on the EEG frequency spectrum . Methods Fourteen healthy men were administered placebo or pindolol ( 20 mg orally ) 90 min before placebo or buspirone ( 30 mg orally ) in a double blind cross-over study . Plasma prolactin and growth hormone were assayed and EEGs recorded before and after drug administration . Results A significant negative shift in the EEG frequency spectrum was found for both buspirone and pindolol , with the combination producing a similar effect to each drug alone . In contrast , the neuroendocrine response to buspirone was significantly attenuated by pindolol . Conclusions The data obtained are consistent with the EEG effects of buspirone and pindolol being mediated by somatodendritic 5-HT1A receptors , in contrast to the neuroendocrine response , which is known to be mediated by postsynaptic receptors . The development of this novel method of assessing somatodendritic 5-HT1A receptors in humans is a potentially important advance which may allow the testing of hypotheses of its involvement in depression and response to antidepressants Meditation-based interventions reduce the relapse risk in recurrently depressed patients . R and omized trials utilizing neurophysiologic outcome measures , however , have yielded inconsistent results with regard to a prophylactic effect . Although frontal brain asymmetry , assessed through electroencephalographic ( EEG ) alpha activity ( 8 - 13 Hz ) , is indicative of approach vs. withdrawal-related response dispositions and represents a vulnerability marker of depression , clinical trials have provided mixed results as to whether meditation has beneficial effects on alpha asymmetry . Inconsistencies might have arisen since such trials relied on resting-state recordings , instead of active paradigms under challenge , as suggested by contemporary notions of alpha asymmetry . We examined two groups of remitted , recurrently depressed females . In a " mindfulness support group " , EEG was recorded during neutral rest , and rest following a negative mood induction . Subsequently , participants received initial meditation instructions . EEG was then obtained during an active period of guided mindfulness meditation and rest following the active period . In a " rumination challenge group " , EEG was obtained during the same resting conditions , whereas in the active period , initial meditation instructions were followed by a rumination challenge . A significant shift in mid-frontal asymmetry , yielding a pattern indicative of approach motivation , was observed in the mindfulness support group , specifically during the meditation period . This indicates that mindfulness meditation may have a transient beneficial effect , which enables patients to take an approach-related motivational stance , particularly under circumstances of risk The human brain spontaneously generates neural oscillations with a large variability in frequency , amplitude , duration , and recurrence . Little , however , is known about the long-term spatiotemporal structure of the complex patterns of ongoing activity . A central unresolved issue is whether fluctuations in oscillatory activity reflect a memory of the dynamics of the system for more than a few seconds . We investigated the temporal correlations of network oscillations in the normal human brain at time scales ranging from a few seconds to several minutes . Ongoing activity during eyes-open and eyes-closed conditions was recorded with simultaneous magnetoencephalography and electroencephalography . Here we show that amplitude fluctuations of 10 and 20 Hz oscillations are correlated over thous and s of oscillation cycles . Our analyses also indicated that these amplitude fluctuations obey power-law scaling behavior . The scaling exponents were highly invariant across subjects . We propose that the large variability , the long-range correlations , and the power-law scaling behavior of spontaneous oscillations find a unifying explanation within the theory of self-organized criticality , which offers a general mechanism for the emergence of correlations and complex dynamics in stochastic multiunit systems . The demonstrated scaling laws pose novel quantitative constraints on computational models of network oscillations . We argue that critical-state dynamics of spontaneous oscillations may lend neural networks capable of quick reorganization during processing dem and OBJECTIVE Selective serotonin reuptake inhibitors ( SSRIs ) are widely used to treat depression , but the rates , timing , and baseline predictors of remission in " real world " patients are not established . The authors ' primary objectives in this study were to evaluate the effectiveness of citalopram , an SSRI , using measurement-based care in actual practice , and to identify predictors of symptom remission in out patients with major depressive disorder . METHOD This clinical study included out patients with major depressive disorder who were treated in 23 psychiatric and 18 primary care " real world " setting s. The patients received flexible doses of citalopram prescribed by clinicians for up to 14 weeks . The clinicians were assisted by a clinical research coordinator in the application of measurement-based care , which included the routine measurement of symptoms and side effects at each treatment visit and the use of a treatment manual that described when and how to modify medication doses based on these measures . Remission was defined as an exit score of < or=7 on the 17-item Hamilton Depression Rating Scale ( HAM-D ) ( primary outcome ) or a score of < or=5 on the 16-item Quick Inventory of Depressive Symptomatology , Self-Report ( QIDS-SR ) ( secondary outcome ) . Response was defined as a reduction of > or=50 % in baseline QIDS-SR score . RESULTS Nearly 80 % of the 2,876 out patients in the analyzed sample had chronic or recurrent major depression ; most also had a number of comorbid general medical and psychiatric conditions . The mean exit citalopram dose was 41.8 mg/day . Remission rates were 28 % ( HAM-D ) and 33 % ( QIDS-SR ) . The response rate was 47 % ( QIDS-SR ) . Patients in primary and psychiatric care setting s did not differ in remission or response rates . A substantial portion of participants who achieved either response or remission at study exit did so at or after 8 weeks of treatment . Participants who were Caucasian , female , employed , or had higher levels of education or income had higher HAM-D remission rates ; longer index episodes , more concurrent psychiatric disorders ( especially anxiety disorders or drug abuse ) , more general medical disorders , and lower baseline function and quality of life were associated with lower HAM-D remission rates . CONCLUSIONS The response and remission rates in this highly generalizable sample with substantial axis I and axis III comorbidity closely resemble those seen in 8-week efficacy trials . The systematic use of easily implemented measurement-based care procedures may have assisted in achieving these results Mindfulness-based stress reduction ( MBSR ) is an established program shown to reduce symptoms of stress , anxiety , and depression . MBSR is believed to alter emotional responding by modifying cognitive-affective processes . Given that social anxiety disorder ( SAD ) is characterized by emotional and attentional biases as well as distorted negative self-beliefs , we examined MBSR-related changes in the brain-behavior indices of emotional reactivity and regulation of negative self-beliefs in patients with SAD . Sixteen patients underwent functional MRI while reacting to negative self-beliefs and while regulating negative emotions using 2 types of attention deployment emotion regulation-breath-focused attention and distraction-focused attention . Post-MBSR , 14 patients completed neuroimaging assessment s. Compared with baseline , MBSR completers showed improvement in anxiety and depression symptoms and self-esteem . During the breath-focused attention task ( but not the distraction-focused attention task ) , they also showed ( a ) decreased negative emotion experience , ( b ) reduced amygdala activity , and ( c ) increased activity in brain regions implicated in attentional deployment . MBSR training in patients with SAD may reduce emotional reactivity while enhancing emotion regulation . These changes might facilitate reduction in SAD-related avoidance behaviors , clinical symptoms , and automatic emotional reactivity to negative self-beliefs in adults with SAD Mindfulness-based cognitive therapy ( MBCT ) effectively prevents relapse/recurrence in major depression . The ability to deploy and maintain attention on a particular focus is considered as a prerequisite for ' mindful ' , ' metacognitive ' awareness , and hence crucial for therapy success . Accordingly , sustained concentration is the skill most extensively taught in MBCT . The goal of the present study was to test whether this ability increases after MBCT , as assumed . The late component of the contingent negative variation ( CNV ) , an event-related brain potential ( ERP ) , known to reflect the allocation of attentional re sources , was used as the measure of concentration ability . In the main phase of the study , 91 recurrently depressed patients in remission were r
Output:
| HIGHLIGHTSThe prefrontal cortex , cingulate cortex , and basal ganglia are modified after MBI in depression .
MBIs have modulatory effects on several brain regions implicated in the pathophysiology of MDD , such as the prefrontal cortex , the basal ganglia , the anterior and posterior cingulate cortices , and the parietal cortex .
These regions have been implicated in self‐awareness , attention and emotion regulation .
Some of these findings were consistent with the effects of MBIs observed in healthy subjects and patients with other psychiatric disorders , especially enhanced activity in the frontal and subcortical regions related to the improved somatosensory awareness . |
MS213943 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
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Input: BACKGROUND Previous , uncontrolled studies have suggested that first-line treatment with gefitinib would be efficacious in selected patients with non-small-cell lung cancer . METHODS In this phase 3 , open-label study , we r and omly assigned previously untreated patients in East Asia who had advanced pulmonary adenocarcinoma and who were nonsmokers or former light smokers to receive gefitinib ( 250 mg per day ) ( 609 patients ) or carboplatin ( at a dose calculated to produce an area under the curve of 5 or 6 mg per milliliter per minute ) plus paclitaxel ( 200 mg per square meter of body-surface area ) ( 608 patients ) . The primary end point was progression-free survival . RESULTS The 12-month rates of progression-free survival were 24.9 % with gefitinib and 6.7 % with carboplatin-paclitaxel . The study met its primary objective of showing the noninferiority of gefitinib and also showed its superiority , as compared with carboplatin-paclitaxel , with respect to progression-free survival in the intention-to-treat population ( hazard ratio for progression or death , 0.74 ; 95 % confidence interval [ CI ] , 0.65 to 0.85 ; P<0.001 ) . In the subgroup of 261 patients who were positive for the epidermal growth factor receptor gene ( EGFR ) mutation , progression-free survival was significantly longer among those who received gefitinib than among those who received carboplatin-paclitaxel ( hazard ratio for progression or death , 0.48 ; 95 % CI , 0.36 to 0.64 ; P<0.001 ) , whereas in the subgroup of 176 patients who were negative for the mutation , progression-free survival was significantly longer among those who received carboplatin-paclitaxel ( hazard ratio for progression or death with gefitinib , 2.85 ; 95 % CI , 2.05 to 3.98 ; P<0.001 ) . The most common adverse events were rash or acne ( in 66.2 % of patients ) and diarrhea ( 46.6 % ) in the gefitinib group and neurotoxic effects ( 69.9 % ) , neutropenia ( 67.1 % ) , and alopecia ( 58.4 % ) in the carboplatin-paclitaxel group . CONCLUSIONS Gefitinib is superior to carboplatin-paclitaxel as an initial treatment for pulmonary adenocarcinoma among nonsmokers or former light smokers in East Asia . The presence in the tumor of a mutation of the EGFR gene is a strong predictor of a better outcome with gefitinib . ( Clinical Trials.gov number , NCT00322452 . PURPOSE Epidermal growth factor receptor ( EGFR ) mutations have been associated with tumor response to treatment with single-agent EGFR inhibitors in patients with relapsed non-small-cell lung cancer ( NSCLC ) . The implication s of EGFR mutations in patients treated with EGFR inhibitors plus first-line chemotherapy are unknown . KRAS is frequently activated in NSCLC . The relationship of KRAS mutations to outcome after EGFR inhibitor treatment has not been described . PATIENTS AND METHODS Previously untreated patients with advanced NSCLC in the phase III TRIBUTE study who were r and omly assigned to carboplatin and paclitaxel with erlotinib or placebo were assessed for survival , response , and time to progression ( TTP ) . EGFR exons 18 through 21 and KRAS exon 2 were sequenced in tumors from 274 patients . Outcomes were correlated with EGFR and KRAS mutations in retrospective subset analyses . RESULTS EGFR mutations were detected in 13 % of tumors and were associated with longer survival , irrespective of treatment ( P < .001 ) . Among erlotinib-treated patients , EGFR mutations were associated with improved response rate ( P < .05 ) and there was a trend toward an erlotinib benefit on TTP ( P = .092 ) , but not improved survival ( P = .96 ) . KRAS mutations ( 21 % of tumors ) were associated with significantly decreased TTP and survival in erlotinib plus chemotherapy-treated patients . CONCLUSION EGFR mutations may be a positive prognostic factor for survival in advanced NSCLC patients treated with chemotherapy with or without erlotinib , and may predict greater likelihood of response . Patients with KRAS-mutant NSCLC showed poorer clinical outcomes when treated with erlotinib and chemotherapy . Further studies are needed to confirm the findings of this retrospective subset analysis PURPOSE This study attempted to determine the prognostic value for survival of various pretreatment characteristics in patients with nonresectable non-small-cell lung cancer in the context of more than 10 years of experience of a European Cooperative Group . PATIENTS AND METHODS We included in the analysis all eligible patients ( N = 1,052 ) with advanced non-small-cell lung cancer registered onto one of seven trials conducted by the European Lung Cancer Working Party ( ELCWP ) during one decade . The patients were treated by chemotherapy regimens based on platinum derivatives . We prospect ively collected 23 variables and analyzed them by univariate and multivariate methods . RESULTS The global estimated median survival time was 29 weeks , with a 95 % confidence interval of 27 to 30 weeks . After univariate analysis , we applied two multivariate statistical techniques . In a Cox regression model , the selected explanatory variables were disease extent , Karnofsky performance status , WBC and neutrophil counts , metastatic involvement of skin , serum calcium level , age , and sex . These results were confirmed by application of recursive partitioning and amalgamation algorithms ( RECPAM ) , which led to classification of the patients into four homogeneous subgroups . CONCLUSION We confirmed by our analysis the role of well-known independent prognostic factors for survival , but also identified the effect of the neutrophil count , rarely studied , with the use of two methods : a classical Cox regression model and a RECPAM analysis . The classification of patients into the four subgroups we obtained needs to be vali date d in other series BACKGROUND This study prospect ively assessed the efficacy of gefitinib and the survival benefit for non-small cell lung cancer ( NSCLC ) patients with epidermal growth factor receptor ( EGFR ) mutations . METHOD Patients with either recurrent disease after undergoing surgery or advanced NSCLC disease ( IIIB or IV ) which demonstrated EGFR mutations were eligible for this study . EGFR mutations in exons 19 - 21 were examined . The patients with EGFR mutations were enrolled in this study after obtaining their informed consent a second time , and they were thereafter treated with gefitinib . RESULTS EGFR mutations were detected in 20 of 48 patients with NSCLC , and 19 patients were enrolled onto this study and treated with gefitinib . Seven patients had an exon 19 deletion , 10 had L858R , 1 had both , and 1 had an exon 19 deletion and G796A . The overall response rate was 63.2 % , and the disease control rate was 89.5 % . In patients with an exon 19 del and L858R , the response rates were 71.4 % and 60.0 % , respectively . The median progression-free survival time was 7.1 months , and the median survival time was 20.0 months . No life-threatening toxicity was observed . Four of five acquired resistant tumors showed an acquired T790 M mutation . CONCLUSIONS EGFR mutations in exons 19 or 21 are considered to be a good predictor of the efficacy of gefitinib
Output:
| The subgroup analysis based on univariate and multivariate analyses in DFS and OS showed no statistically significant difference .
There was also no statistically significant difference in DFS and OS of stage I NSCLC patients .
The systematic review with meta- analysis showed that EGFR mutations were not a prognostic factor in patients with surgically resected non-small cell lung cancer . |
MS213944 | ***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: OBJECTIVES to evaluate the effect of two interventions on reducing antibiotic prescription in pharyngitis . METHODS a prospect i ve , non-r and omized , before-after controlled study was carried out in primary care centres throughout Spain . General practitioners ( GPs ) registered all cases of pharyngitis during a 3 week period before and after two types of intervention in 2008 and 2009 , respectively . Full intervention consisted of discussion sessions of the results of the first registry , courses for GPs , guidelines , patient information leaflets , workshops on rapid tests and the use of rapid antigen detection tests ( RADTs ) in their consulting offices . The physicians in the partial intervention group underwent all the above intervention except for the workshop , and RADTs were not provided . A control group was also included in 2009 . Multilevel logistic regression was performed considering the prescription of antibiotics as the dependent variable . RESULTS a total of 280 GPs registered cases with pharyngitis ( 70 partial intervention and 210 full intervention ) . Fifty-nine new physicians were included as a control group . A total of 6849 episodes of pharyngitis were registered . Antibiotic prescription was significantly lower after intervention for the full intervention group , but not for the partial intervention group . According to the multivariate model , in comparison with the control group , the odds ratio of antibiotic prescription after the intervention was 0.52 [ 95 % confidence interval ( 95 % CI ) 0.23 - 1.18 ] in the partial intervention group and 0.23 ( 95 % CI 0.11 - 0.47 ) in the full intervention group . CONCLUSIONS intervention was beneficial for reducing the prescription of antibiotics , but was only statistically significant when the GPs were provided with RADTs BACKGROUND A multiple intervention targeted to reduce antibiotic prescribing with an educational outreach programme had proven to be effective in a r and omized controlled trial in 12 peer review groups , demonstrating 12 % less prescriptions for respiratory tract infections . OBJECTIVE To assess the effectiveness of a multiple intervention in primary care at a large scale . METHODS A controlled before and after study in 2006 and 2007 was design ed . Participants were from general practice s within a geographically defined area in the middle region of The Netherl and s. Participants were GPs in 141 practice s in 25 peer review groups . A control group of GP practice s from the same region , matched for type of practice and mean volume of antibiotic prescribing . The multiple intervention consisted of the following elements : ( i ) group education meeting and communication training ; ( ii ) monitoring and feedback on prescribing behaviour ; ( iii ) group education for GPs and pharmacists assistants and ( iv ) patient education material . The main outcome measures are as follows : ( i ) number of antibiotic prescriptions per 1000 patients per GP and ( ii ) number of second-choice antibiotics , obtained from cl aims data from the regional health insurance company . The associations between predictors and outcome measurements were assessed by means of a multiple regression analyses . RESULTS At baseline , the number of antibiotic prescriptions per 1000 patients was slightly higher in the intervention group than in the control group ( 184 versus 176 ) . In 2007 , the number of prescriptions had increased to 232 and 227 , respectively , and not differed between intervention and control group . CONCLUSIONS The implementation of an already proven effective multiple intervention strategy at a larger scale showed no reduction of antibiotic prescription rates . The failure might be attributed to a less tight monitoring of intervention and audit . Inserting practical tools in the intervention might be more successful and should be studied OBJECTIVE This study assessed the effect of a h and held computer-based decision support system ( DSS ) on antibiotic use and patient outcomes in a critical care unit . DESIGN A DSS containing four types of evidence ( patient microbiology reports , local antibiotic guidelines , unit-specific antibiotic susceptibility data for common bacterial pathogens , and a clinical pulmonary infection score calculator ) was developed and implemented on a h and held computer for use in the intensive care unit at a tertiary referral hospital . System impact was assessed in a prospect i ve " before/after " cohort trial lasting 12 months . Outcome measures were defined daily doses ( DDDs ) of antibiotics per 1,000 patient-days , patient length of stay , and mortality . RESULTS The number of admissions , APACHE ( Acute Physiology , Age , and Chronic Health Evaluation ) II and SAPS ( Simplified Acute Physiology Score ) II for patients in preintervention , and intervention ( DSS use ) periods were statistically comparable . The mean patient length of stay and the use of antibiotics in the unit during six months of the DSS use decreased from 7.15 to 6.22 bed-days ( p = 0.02 ) and from 1,767 DDD to 1,458 DDD per 1,000 patient-days ( p = 0.04 ) , respectively , with no change in mortality . The DSS was accessed 674 times during 168 days of the trial . Microbiology reports and antibiotic guidelines were the two most commonly used ( 53 % and 22.5 % , respectively ) types of evidence . The greatest reduction was observed in the use of beta-lactamase-resistant penicillins and vancomycin . CONCLUSION H and held computer-based decision support contributed to a significant reduction in patient length of stay and antibiotic prescribing in a critical care unit Background Acute respiratory tract infections ( ARTI ) are among the most frequent reasons for consultations in primary care . Although predominantly viral in origin , ARTI often lead to the prescription of antibiotics for ambulatory patients , mainly because it is difficult to distinguish between viral and bacterial infections . Unnecessary antibiotic use , however , is associated with increased drug expenditure , side effects and antibiotic resistance . A novel approach is to guide antibiotic therapy by procalcitonin ( ProCT ) , since serum levels of ProCT are elevated in bacterial infections but remain lower in viral infections and inflammatory diseases . The aim of this trial is to compare a ProCT-guided antibiotic therapy with a st and ard approach based on evidence -based guidelines for patients with ARTI in primary care . Methods / Design This is a r and omised controlled trial in primary care with an open intervention . Adult patients judged by their general practitioner ( GP ) to need antibiotics for ARTI are r and omised in equal numbers either to st and ard antibiotic therapy or to ProCT-guided antibiotic therapy . Patients are followed-up after 1 week by their GP and after 2 and 4 weeks by phone interviews carried out by medical students blinded to the goal of the trial . Exclusion criteria for patients are antibiotic use in the previous 28 days , psychiatric disorders or inability to give written informed consent , not being fluent in German , severe immunosuppression , intravenous drug use , cystic fibrosis , active tuberculosis , or need for immediate hospitalisation . The primary endpoint is days with restrictions from ARTI within 14 days after r and omisation . Secondary outcomes are antibiotic use in terms of antibiotic prescription rate and duration of antibiotic treatment in days , days off work and days with side-effects from medication within 14 days , and relapse rate from the infection within 28 days after r and omisation . Discussion We aim to include 600 patients from 50 general practice s in the Northwest of Switzerl and . Data from the registry of the Swiss Medical Association suggests that our recruited GPs are representative of all eligible GPs with respect to age , proportion of female physicians , specialisation , years of postgraduate training and years in private practice OBJECTIVE Computerized medical decision support tools have been shown to improve the quality of care and have been cited by the Institute of Medicine as one method to reduce pharmaceutical errors . We evaluated the impact of an antiinfective decision support tool in a pediatric intensive care unit ( PICU ) . METHODS We enhanced an existing adult antiinfective management tool by adding and changing medical logic to make it appropriate for pediatric patients . Process and outcomes measures were monitored prospect ively during a 6-month control and a 6-month intervention period . M and atory use of the decision support tool was initiated for all antiinfective orders in a 26-bed PICU during the intervention period . Clinician opinions of the decision support tool were surveyed via question naire . RESULTS The rate of pharmacy interventions for erroneous drug doses declined by 59 % . The rate of anti-infective subtherapeutic patient days decreased by 36 % , and the rate of excessive-dose days declined by 28 % . The number of orders placed per antiinfective course decreased 11.5 % , and the robust estimate of the antiinfective costs per patient decreased 9 % . The type of anti-infectives ordered and the number of antiinfective doses per patient remained similar , as did the rates of adverse drug events and antibiotic-bacterial susceptibility mismatches . The surveyed clinicians reported that use of the program improved their antiinfective agent choices as well as their awareness of impairments in renal function and reduced the likelihood of adverse drug events . CONCLUSIONS Use of the pediatric antiinfective decision support tool in a PICU was considered beneficial to patient care by the clinicians and reduced the rates of erroneous drug orders , improved therapeutic dosage targets , and was associated with a decreased robust estimate of antiinfective costs per patient . antiinfective agents , decision support systems , drug therapy , medication errors , child , infant BACKGROUND Antibiotic misuse is common and costly and may promote antibiotic resistance . We tested the efficacy of a targeted one-on-one educational program ( " academic detailing " ) design ed to improve the appropriateness of broad-spectrum antibiotic use . METHODS A r and omized controlled trial was conducted in a large US teaching hospital . During an 18-week study period , 17 general medical , oncology , and cardiology services either received academic detailing or did not . The intervention was prompted by an order for either levofloxacin or ceftazidime that led to a computer-based review of data for that patient . Orders for the 2 target antibiotics deemed unnecessary by a priori criteria were included in the study . The primary outcome examined was the number of days that unnecessary levofloxacin or ceftazidime was administered in intervention and control groups . RESULTS Before the trial , intervention and control services had similar prescribing patterns for the target antibiotics ; the drugs were used for similar indications throughout the study period . During the intervention , there was a reduction of 37 % in days of unnecessary levofloxacin or ceftazidime use per 2-week interval on services r and omized to the educational intervention vs control services ( P < .001 ) . In multivariable analyses controlling for baseline prescribing and study interval , the rate of unnecessary use of the 2 target antibiotics was reduced by 41 % on the intervention services compared with controls ( 95 % confidence interval , 44%-78 % ; P < .001 ) . Length of stay , intensive care unit transfers , readmission rates , and in-hospital death rates were similar in both groups ( P > or = .10 for all ) . CONCLUSION Targeted one-on-one education is a practical , effective , and safe method for reducing excessive broad-spectrum antibiotic use From 1998 to 2000 , 13 rural Alaskan villages ( population , 3326 ) were surveyed annually by nasopharyngeal cultures for Streptococcus pneumoniae carriage . Data regarding antibiotic use for the entire population was abstract ed from clinic records . In 1999 , education of medical providers and the community about appropriate antibiotic use began in 4 villages ; this program was exp and ed to include all villages in 2000 . Antibiotic courses per person decreased by 31 % in the initial intervention villages and by 35 % in the remaining villages after education ( P<.01 for each ) . Sample s were obtained for culture from a mean of 31 % of the population each year ; 31 % carried pneumococcus . No sustained decrease in carriage of penicillin-nonsusceptible strains was observed . When linear regression was used , serotype accounted for 81 % of the variance in pneumococcal minimum inhibitory concentrations after the intervention , compared with 7 % for antibiotic use . This suggests that reducing the carriage of serotypes associated with antibiotic resistance by use of pneumococcal conjugate vaccines may have a greater short-term impact than does decreasing antibiotic use Objective The study objective was to evaluate the effectiveness of an operational multidisciplinary antibiotic team , including an infectious disease physician and a clinical pharmacist , in reducing the hospital antimicrobial consumption and costs . Setting The 1800-bed University Hospitals of Nancy ( France ) . Method A cluster controlled ‘ before-after ’ study was performed . The intervention group comprised 11 medical and surgical wards in setting s where the operational antibiotic team was implemented , and the control group comprised 6 wards without this operational team . The ‘ before ’ period ( 2005 ) preceded the implementation of the operational team in the intervention group and ‘ after ’ ( July 2007 to June 2008 ) followed its full implementation . Main outcome measure We compared consumption of antibiotics overall and by therapeutic class ( in defined daily doses per 1,000 patient days ) and cost savings ( in € ) between ‘ before ’ and ‘ after ’ in both groups ( control and intervention ) , using a mixed effect linear model . Results
Output:
| Conclusion The results show that antibiotic use could be improved by educational interventions , being mostly used multifaceted interventions |
MS213945 | ***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: Abstract Objective : To evaluate the use of a computerised support system for decision making for implementing evidence based clinical guidelines for the management of asthma and angina in adults in primary care . Design : A before and after pragmatic cluster r and omised controlled trial utilising a two by two incomplete block design . Setting : 60 general practice s in north east Engl and . Participants : General practitioners and practice nurses in the study practice s and their patients aged 18 or over with angina or asthma . Main outcome measures : Adherence to the guidelines , based on review of case notes and patient reported generic and condition specific outcome measures . Results : The computerised decision support system had no significant effect on consultation rates , process of care measures ( including prescribing ) , or any patient reported outcomes for either condition . Levels of use of the software were low . Conclusions : No effect was found of computerised evidence based guidelines on the management of asthma or angina in adults in primary care . This was probably due to low levels of use of the software , despite the system being optimised as far as was technically possible . Even if the technical problems of producing a system that fully supports the management of chronic disease were solved , there remains the challenge of integrating the systems into clinical encounters where busy practitioners manage patients with complex , multiple conditions UNLABELLED What is already known about this subject . Computerized prompts and reminders have been shown to be effective in changing the behaviour of health professionals in a variety of setting s. There is little literature describing or evaluating electronic decision-support for pharmacists . What this study adds . An electronic prompt in dispensing software for a targeted clinical intervention has a significant effect on pharmacists ' behaviour . A markedly increased rate of recording and performing the targeted clinical intervention was found . The effect of the prompt reduces markedly once the prompt is deactivated . AIM To evaluate the effect of an electronic prompt in dispensing software on the frequency of clinical interventions recorded by community pharmacists . METHOD An electronic decision-support prompt identifying patients for a targeted proactive clinical intervention was developed and implemented . Each time an oral antidiabetic agent was dispensed , a prompt was displayed reminding pharmacists to discuss the suitability of aspirin therapy in eligible patients with diabetes . The prompt was r and omly assigned to 31 of 52 metropolitan pharmacies in Melbourne ( Australia ) for 6 weeks , with the remaining pharmacies as controls . RESULTS One hundred and fifty pharmacists in 52 pharmacies recorded a total of 2396 clinical interventions at an intervention rate of 0.92 interventions per 100 patients [ 95 % confidence interval ( CI ) 0.58 , 1.23 ] . Pharmacists recorded a total of 201 target interventions related to aspirin therapy in diabetes at an intervention rate of 2.55 interventions per 100 diabetic patients ( 95 % CI 0.85 , 4.24 ) . All of the targeted clinical interventions were recorded in the prompt arm ; no targeted interventions were recorded in the control group . The effect of the prompt decreased over the study period and was not maintained after prompt deactivation . CONCLUSION An electronic prompt significantly increased pharmacists ' recording of the targeted clinical intervention in diabetic patients . An electronic decision-support prompt has significant potential to promote community pharmacists ' contribution to the quality use of medicines BACKGROUND Adverse drug-related events are common in the elderly , and inappropriate prescribing is a preventable risk factor . Our objective was to determine whether inappropriate prescribing could be reduced when primary care physicians had computer-based access to information on all prescriptions dispensed and automated alerts for potential prescribing problems . METHODS We r and omly assigned 107 primary care physicians with at least 100 patients aged 66 years and older ( total 12 560 ) to a group receiving computerized decision-making support ( CDS ) or a control group . Physicians in the CDS group had access to information on current and past prescriptions through a dedicated computer link to the provincial seniors ' drug-insurance program . When any of 159 clinical ly relevant prescribing problems were identified by the CDS software , the physician received an alert that identified the nature of the problem , possible consequences and alternative therapy . The rate of initiation and discontinuation of potentially inappropriate prescriptions was assessed over a 13-month period . RESULTS In the 2 months before the study , 31.8 % of the patients in the CDS group and 33.3 % of those in the control group had at least 1 potentially inappropriate prescription . During the study the number of new potentially inappropriate prescriptions per 1000 visits was significantly lower ( 18 % ) in the CDS group than in the control group ( relative rate [ RR ] 0.82 , 95 % confidence interval [ CI ] 0.69 - 0.98 ) , but differences between the groups in the rate of discontinuation of potentially inappropriate prescriptions were significant only for therapeutic duplication by the study physician and another physician ( RR 1.66 , 95 % CI 0.99 - 2.79 ) and drug interactions caused by prescriptions written by the study physician ( RR 2.15 , 95 % CI 0.98 - 4.70 ) . INTERPRETATION Computer-based access to complete drug profiles and alerts about potential prescribing problems reduces the rate of initiation of potentially inappropriate prescriptions but has a more selective effect on the discontinuation of such prescriptions Background — Indirect evidence shows that alerting users with clinical decision support systems seems to change behavior more than requiring users to actively initiate the system . However , r and omized trials comparing these methods in a clinical setting are lacking . We studied the effect of both alerting and on-dem and decision support with respect to screening and treatment of dyslipidemia based on the guidelines of the Dutch College of General Practitioners . Methods and Results — In a clustered r and omized trial design , 38 Dutch general practice s ( 77 physicians ) and 87 886 of their patients ( 39 433 men 18 to 70 years of age and 48 453 women 18 to 75 years of age ) who used the ELIAS electronic health record participated . Each practice was assigned to receive alerts , on-dem and support , or no intervention . We measured the percentage of patients screened and treated after 12 months of follow-up . In the alerting group , 65 % of the patients requiring screening were screened ( relative risk versus control=1.76 ; 95 % confidence interval , 1.41 to 2.20 ) compared with 35 % of patients in the on-dem and group ( relative risk versus control=1.28 ; 95 % confidence interval , 0.98 to 1.68 ) and 25 % of patients in the control group . In the alerting group , 66 % of patients requiring treatment were treated ( relative risk versus control=1.40 ; 95 % confidence interval , 1.15 to 1.70 ) compared with 40 % of patients ( relative risk versus control=1.19 ; 95 % confidence interval , 0.94 to 1.50 ) in the on-dem and group and 36 % of patients in the control group . Conclusion — The alerting version of the clinical decision support systems significantly improved screening and treatment performance for dyslipidemia by general practitioners BACKGROUND A cluster r and omized trial of tailored interventions to support the implementation of guidelines for sore throat and urinary tract infection found little or no change in the main outcomes , which were antibiotic prescriptions , use of laboratory tests and use of telephone consultations . There was great variation between the practice s in the change in these outcomes . OBJECTIVES Our aim was to evaluate how the interventions were received and to underst and why practice s did or did not change . METHODS The trial was conducted in general practice s in Norway . Data for this process evaluation were collected from the 120 practice s that completed the trial . Multiple methods were used : observations , semi-structured telephone interviews , a postal survey and data extracted from electronic medical records . We investigated factors that might explain a lack of change , including : agreement with the guidelines ; communication within each practice ; degree of participation in the project ; taking time to discuss the guidelines and their implementation ; use of the components of the interventions ; and routines for telephone consultations . Possible explanatory factors were explored in relation to variation in change and the overall extent of change in rates of use of antibiotics , laboratory tests and telephone consultations . RESULTS Sixty-three per cent of practice s agreed with the guidelines . Only 35 % reported having regular meetings , and 33 % discussed the project before its start , although 75 % reported agreement about participating within the practice . Only 33 % reported meeting to discuss the guidelines . Use of the components of the interventions ranged from 11 % for the increased fee for telephone consultations to 48 % for the computerized decision support . Forty-four per cent reported problems with telephone routines . No single factor explained the observed variation in the extent of change across practice s. CONCLUSIONS Inadequate time , re sources and support were the most salient factors that might explain a lack of change . Problems with internal communication and telephone routines were important contributing factors in many practice OBJECTIVES To determine whether a computerized tool that alerted pharmacists when patients aged 65 and older were newly prescribed potentially inappropriate medications was effective in decreasing the proportion of patients dispensed these medications . DESIGN Prospect i ve , r and omized trial . SETTING U.S. health maintenance organization . PARTICIPANTS All 59,680 health plan members aged 65 and older were r and omized to intervention ( n=29,840 ) or usual care ( n=29,840 ) . Pharmacists received alerts on all patients r and omized to intervention who were newly prescribed a targeted medication . INTERVENTION Prescription and age information were linked to alert pharmacists when a patient aged 65 and older was newly prescribed one of 11 medications that are potentially inappropriate in older people . MEASUREMENTS Physicians and pharmacists collaborated to develop the targeted medication list , indications for medication use for which an intervention should occur , intervention guidelines and scripts , and to implement the intervention . RESULTS Over the 1-year study , 543 ( 1.8 % ) intervention group patients aged 65 and older were newly dispensed prescriptions for targeted medications , compared with 644 ( 2.2 % ) usual care group patients ( P=.002 ) . For medication use indications in which an intervention should occur , dispensings of amitriptyline ( P<.001 ) and diazepam ( P=.02 ) were reduced . CONCLUSIONS This study demonstrated the effectiveness of a computerized pharmacy alert system plus collaboration between healthcare professionals in decreasing potentially inappropriate medication dispensings in elderly patients . Coupling data available from information systems with the knowledge and skills of physicians and pharmacists can improve prescribing safety in patients aged 65 and older OBJECTIVE To assess the effects on health care re source utilization of a network of microcomputer workstations for writing all inpatient orders . DESIGN R and omized controlled clinical trial . SETTING Inpatient internal medicine service of an urban public hospital . SUBJECTS A total of 5219 internal medicine patients and the 68 teams of house officers , medical students , and faculty internists who cared for them . INTERVENTION Microcomputer workstations , linked to a comprehensive electronic medical record system , for writing all inpatient orders . MAIN OUTCOME MEASURES Total inpatient charges for each admission and charges for specific categories of orders . A time-motion study of selected interns assessed the ordering system 's time consumption . RESULTS Intervention teams generated charges that were $ 887 ( 12.7 % ) lower per admission than did control teams ( P = .02 ) . Significant reductions ( P < .05 ) were demonstrated separately for bed charges , diagnostic test charges , and drug charges . Reductions of similar proportion and statistical significance were found for hospital costs . The mean length of stay was 0.89 day shorter for intervention resident teams ( P = .11 ) . Interns in the intervention group spent an average of 33 minutes longer ( 5.5 minutes per patient ) during a 10-hour observation period writing orders than did interns in the control group ( P < .0001 ) . CONCLUSIONS A network of microcomputer workstations for writing all inpatient orders significantly lowered patient charges and hospital costs . This would amount to savings of more than $ 3 million in charges annually for this hospital 's medicine service and potentially tens of billions of dollars nationwide . However , the system required more physician time than did the paper charts . Research at other sites and system advances to reduce time requirements are warranted Abstract Objective To test the effectiveness of educational interventions in improving detection rates and management of dementia in primary care . Design Unblinded , cluster r and omised , before and after controlled study . Setting General practice s in the United Kingdom ( central Scotl and and London ) between 1999 and 2002 . Interventions Three educational interventions : an electronic tutorial carried on a CD Rom ; decision support software built into the electronic medical record ; and practice based workshops . Participants 36 practice s participated in the study . Eight practice s were r and omly assigned to the electronic tutorial ; eight to decision support software ; 10 to practice based workshops ; and 10 to control . Electronic and manual search es yielded 450 valid and usable medical records . Main outcome measures Rates of detection of dementia and the extent to which medical records showed evidence of improved concordance with guidelines regarding diagnosis and management . Results Decision support software ( P = 0.01 ) and practice based workshops ( P = 0.01 ) both significantly improved rates of detection compared with control . There were no significant differences by intervention in the measures of concordance with guidelines . Conclusions Decision support systems and practice based workshops are effective educational approaches in improving detection rates in dementia
Output:
| Conclusions CCDSSs inconsistently improved process of care measures and seldomly improved patient outcomes .
Lack of clear patient benefit and lack of data on harms and costs preclude a recommendation to adopt CCDSSs for drug therapy management |
MS213946 | ***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 The Providing Assistance to Caregivers in Transition ( PACT ) program offers nursing home discharge planning and case management for individuals in the transitional period following a return to the community . The PACT program targeted individuals newly admitted to nursing homes and worked with a family caregiver to develop and implement a nursing home discharge plan . DESIGN AND METHOD Reported are the results of a r and omized control design evaluating the program 's effectiveness . Those individuals r and omly assigned to the intervention group ( n = 33 ) received PACT case management in addition to their usual medical and nursing home care . The individuals in the control group ( n = 29 ) continued their usual care . RESULT There were no statistical differences in the discharge rate ( 84 % treatment vs 76 % controls ) or in the median length of stay ( 42 days vs 55 days ) between the two groups of individuals . IMPLICATION S Replications or extensions of a PACT-type intervention might consider a broader mix of nursing homes , working directly with the nursing home 's admission Minimum Data Set coordinator in patient selection , or working with Medicare or Medicaid HMO plans The purpose of this pilot study was to test the initial efficacy , feasibility , and safety of a specially design ed postacute care transitional rehabilitation intervention for cardiac patients . Cardiac Transitional Rehabilitation Using Self-Management Techniques ( Cardiac TRUST ) is a family-focused intervention that includes progressive low-intensity walking and education in self-management skills to facilitate recovery following a cardiac event . Using a r and omized two-group design , exercise self-efficacy , steps walked , and participation in an outpatient cardiac rehabilitation ( CR ) program were compared in a sample of 38 older adults ( 17 Cardiac TRUST , 21 usual care ) . At discharge from postacute care , the intervention group trended toward higher levels of self-efficacy for exercise outcomes than the usual care group . During the 6 weeks following discharge , the intervention group had greater attendance in outpatient CR and a trend toward more steps walked during the first week . The feasibility of the intervention was better for the home health care participants than for those in the skilled nursing facility . The provision of CR during postacute care has the potential to bridge the gap in transitional services from hospitalization to outpatient CR for these patients at high risk for future cardiac events . Further evidence of the efficacy of Cardiac TRUST is warranted Context The relationship between factors indicative of personal socioeconomic disadvantage , such as where patients live , and readmission risk is unclear . Contribution The authors linked the ZIP+4 codes for Medicare patients ' residences to census block groups in the 2000 U.S. census . For each census block group ( or neighborhood ) , they calculated an area deprivation index score . Multivariable models assessed the relationship between area deprivation index score rankings and rehospitalization , controlling for patient and hospital characteristics . Caution The study did not assess the quality of care provided by the hospitals . Implication Medicare patients from disadvantaged neighborhoods have an increased risk for rehospitalization . The Editors Thirty-day rehospitalizations affect 1 in 5 hospitalized Medicare patients , cost more than $ 17 billion annually , and result in hospital-based Medicare payment penalties for congestive heart failure , pneumonia , and acute myocardial infa rct ion rehospitalizations ( 1 ) . Most persons believe that all hospitals can prevent at least some rehospitalizations by using a spectrum of programs to better support vulnerable patients during the high-risk period after hospital discharge ( 13 ) . However , the targeting of these programs has proven challenging , potentially because important factors contributing to rehospitalizations , such as socioeconomic disadvantage , are not well-measured ( 4 , 5 ) . Socioeconomic disadvantage is a complex theoretical concept , which describes the state of being challenged by low income , limited education , and subst and ard living conditions for both the person and his or her neighborhood or social network ( 6 , 7 ) . Detailed assessment of an individual patient 's socioeconomic status is a time-consuming and potentially uncomfortable task to add to a clinical encounter , and because such information is rarely available in the patient 's medical record , clinical teams often overlook socioeconomic factors when creating individualized care plans after hospital discharge ( 8) . Measures of neighborhood socioeconomic disadvantage , such as concentration of poverty in the neighborhood surrounding the patient 's residence , could be more easily accessed and assigned as a risk factor at the point of patient admission by using the patient 's address . However , the association between neighborhood disadvantage and rehospitalization risk has not yet been established . It is plausible that neighborhood socioeconomic disadvantage would influence rehospitalization risk because vulnerable patients depend on neighborhood supports for stability generally ( 912 ) , and these needs are likely to be increased in the period after hospital discharge ( 3 ) . Safety-net hospitals in the United States , which serve socioeconomically disadvantaged areas , are more apt to be financially penalized for their rehospitalization rates ( 1316 ) . Living in a socioeconomically disadvantaged neighborhood has been associated with health behaviors ( 17 ) ; access to food ( 18 , 19 ) and safety ( 20 ) ; and outcomes , such as mortality ( 10 , 1217 ) , birthweight ( 21 ) , and rehospitalization risk for heart failure ( 22 ) . In addition , important health indicators improve with moving persons to areas of less concentrated poverty ( 23 , 24 ) . In 2003 , Singh created a composite measure of neighborhood socioeconomic disadvantage for the United States , the area deprivation index ( ADI ) , on the basis of similar measures used in many other countries for re source planning and health policy development ( 2529 ) . The ADI is a factor-based index that uses 17 U.S. census poverty , education , housing , and employment indicators to characterize census-based regions ( 25 , 2729 ) . It has been correlated with many health outcomes , including all-cause , cardiovascular , cancer , and childhood mortality and cervical cancer prevalence ( 25 , 2732 ) . Socioeconomic disadvantage based on neighborhood risk through a ZIP codelinked ADI does not require a potentially lengthy and intrusive discussion with patients and families and could easily be made available to clinical teams and policymakers . Our objective was to determine whether neighborhood socioeconomic disadvantage could be useful to clinical planning by examining its relevance in a population likely to be targeted by clinical improvement activities design ed to reduce readmission risk . We analyzed the association between ADI ( defined at the census block group level ) and 30-day rehospitalizations for patients discharged with congestive heart failure , pneumonia , or acute myocardial infa rct ion , the clinical conditions used for the current calculation of Medicare 's rehospitalization penalties . Methods Data Sources and Study Population We used data from 2004 to 2009 from the Chronic Condition Data Warehouse ( 33 ) , including Medicare cl aims and enrollment files prelinked to annual Medicare provider of service files for a 5 % r and om national sample of Medicare beneficiaries . Beneficiaries who received railroad retirement benefits or were in an HMO were excluded because these groups have incomplete data . We identified 307 827 patients who were older than 65 years hospitalized with congestive heart failure , acute myocardial infa rct ion , or pneumonia using Medicare readmission measure definitions ( 3436 ) . We used the ZIP+4 code listed for the patient 's residence within Medicare data to link to the census block group with the same ZIP+4 area in 2000 U.S. census data for the 50 U.S. states and the District of Columbia . Each census block group covers an area of 600 to 3000 persons , averaging 1500 persons per group ( 37 ) . We excluded 52 083 patients without a ZIP+4 code in their Medicare data ( n = 9741 ) or whose documented ZIP+4 code did not exist in the 2000 census data ( n = 42 342 ) . Patients in this latter category may include those who design ate a post office box as their primary residence or those who reside in new ZIP+4 areas , U.S. territories , or institutions ( such as prisons ) . H and -checking of a small r and om sampling of these patients ' ZIP+4 codes suggests that most were assigned to a post office box . The final sample size was 255 744 patients . These patients originated from 4802 unique hospitals ( mean patients per hospital , 53.3 ; range , 1 to 743 patients ) . The University of Wisconsin Institutional Review Board approved this study . Variables Census Block GroupLevel Variables We calculated ADI scores for each U.S. census block group using the Singh method ( 14 , 1618 ) . This involved summing Singh 's 17 census indicators weighted by Singh 's factor score coefficients for each indicator ( 25 ) ( Table 1 ) . The Appendix contains more detail on constructing the ADI . We examined the distribution of ADI values and sorted neighborhoods into percentiles by increasing ADI . Table 1 . Census Data Block Group Components and Factor Score Coefficients in the Singh ADI Patient-Level Variables We constructed all-cause rehospitalization within 30 days of discharge from Medicare cl aims ( 3436 ) . Other variables drawn from Medicare files included patient age , sex , race , Medicaid status , initial Medicare enrollment due to disability , index hospitalization length of stay , and discharge to a skilled-nursing facility . Race was categorized as white , black , or other based on the beneficiary race code . Each patient 's Centers for Medicare & Medicaid Services hierarchical condition category score , calculated from all outpatient and inpatient cl aims over the 12 months before the index hospitalization , was included as a risk adjustment measure ( 38 ) . Comorbid conditions were identified using Elixhauser methods , incorporating data from the index hospitalization and from all hospitalizations and physician cl aims during the year before the index hospitalization ( 39 ) . Of the comorbid conditions identified using this approach , 17 had frequencies of greater than 5 % in the sample and were included as indicators . Comorbid conditions occurring less often were compiled into an other comorbid condition indicator and included alcohol or drug abuse , rheumatoid arthritis , collagen vascular disease , chronic blood loss anemia , liver disease , lymphoma , metastatic cancer , solid tumor without metastases , paralysis , psychoses , and peptic ulcer disease . We assessed the rurality of each patient 's ZIP code of residence using the U.S. Department of Agriculture 's ruralurban commuting area codes , grouped into categories of urban core areas , suburban areas , large town areas , and small town or isolated rural areas ( 40 , 41 ) . Index hospital characteristics , including Medicare geographic region , for-profit status , and medical school affiliation , were drawn from the Medicare provider of service file corresponding to the patient 's index hospitalization date ( 42 ) . We estimated the annual Medicare discharge volume for each hospital by multiplying the number of cl aims from each hospital in the 5 % national sample by 20 . We then grouped hospitals into low- , middle- , and high-volume tertiles . Approximately 0.1 % of our sample was missing data on race ( n = 291 ) , and less than 0.3 % were missing data on hospital medical school affiliation ( n = 777 ) and for-profit status ( n = 777 ) . There were no missing data for other patient-level variables . Statistical Analysis We examined the unadjusted relationship between ADI percentile and 30-day rehospitalization , overall and by primary disease . On the basis of the empirical ADI data , the most disadvantaged neighborhoods made up the top 15 % of the distribution . To better assess within-group differences , we divided this most disadvantaged 15 % into 3 equally sized 5 % groupings representing the third-most , second-most , and most disadvantaged 5 % of neighborhoods . The remaining neighborhoods ( 85 % ) were grouped into a comparator category . We examined frequencies of patient and index hospital characteristics for each grouping . We used logistic regression to assess the relationship between ADI grouping and 30-day rehospitalization . Next , to assess the full spectrum of ADI effect , we divided STUDY OBJECTIVE To assess the impact of a pilot pharmacist-managed medication reconciliation program on mortality and use of health care services in patients discharged to home from a skilled nursing facility ( SNF ) . DESIGN Quasi-experimental , controlled trial . SETTING Health maintenance organization ( HMO ) . PATIENTS Five hundred twenty-one HMO members . INTERVENTION Patients were assigned to the medication reconciliation program ( 113 patients ) or to the usual care control group ( 408 patients ) after discharge to home from an SNF . Assignment to the medication reconciliation group or to the control group was based on provider su bmi ssion of a discharge summary within 0 - 48 hours of discharge or more than 48 hours after discharge , respectively . MEASUREMENTS AND MAIN RESULTS Integrated electronic medical and pharmacy data and multivariate analyses were used to assess the medication reconciliation program with regard to its impact on postdischarge mortality , rehospitalization , and ambulatory clinic and emergency department visits . Compared with usual care during the 60 days after discharge from the SNF , patients who received the medication reconciliation intervention had an adjusted 78 % reduction in the risk of death ( adjusted hazard ratio 0.22 , 95 % confidence interval [ CI ] 0.06 - 0.88 ) and a trend toward an increased rate of ambulatory care visits ( adjusted incidence risk ratio 1.17 , 95 % CI 0.99 - 1.37 ) . No significant differences were noted in adjusted risks
Output:
| Although the risk for bias was high across studies , the findings suggest that there is promising but limited evidence that transitional care improves clinical outcomes for SNF patients . |
MS213947 | ***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 Radical cystectomy ( RC ) for bladder cancer is frequently associated with delayed gastrointestinal ( GI ) recovery that prolongs hospital length of stay ( LOS ) . OBJECTIVE To assess the efficacy of alvimopan to accelerate GI recovery after RC . DESIGN , SETTING , AND PARTICIPANTS We conducted a r and omized double-blind placebo-controlled trial in patients undergoing RC and receiving postoperative intravenous patient-controlled opioid analgesics . INTERVENTION Oral alvimopan 12 mg ( maximum : 15 inpatient doses ) versus placebo . OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS The two-component primary end point was time to upper ( first tolerance of solid food ) and lower ( first bowel movement ) GI recovery ( GI-2 ) . Time to discharge order written , postoperative LOS , postoperative ileus (POI)-related morbidity , opioid consumption , and adverse events ( AEs ) were evaluated . An independent adjudication of cardiovascular AEs was performed . RESULTS AND LIMITATIONS Patients were r and omized to alvimopan ( n=143 ) or placebo ( n=137 ) ; 277 patients were included in the modified intention-to-treat population . The alvimopan cohort experienced quicker GI-2 recovery ( 5.5 vs 6.8 d ; hazard ratio : 1.8 ; p<0.0001 ) , shorter mean LOS ( 7.4 vs 10.1 d ; p=0.0051 ) , and fewer episodes of POI-related morbidity ( 8.4 % vs 29.1 % ; p<0.001 ) . The incidence of opioid consumption and AEs or serious AEs ( SAEs ) was comparable except for POI , which was lower in the alvimopan group ( AEs : 7 % vs 26 % ; SAEs : 5 % vs 20 % , respectively ) . Cardiovascular AEs occurred in 8.4 % ( alvimopan ) and 15.3 % ( placebo ) of patients ( p=0.09 ) . Generalizability may be limited due to the exclusion of epidural analgesia and the inclusion of mostly high-volume centers utilizing open laparotomy . CONCLUSIONS Alvimopan is a useful addition to a st and ardized care pathway in patients undergoing RC by accelerating GI recovery and shortening LOS , with a safety profile similar to placebo . PATIENT SUMMARY This study examined the effects of alvimopan on bowel recovery in patients undergoing radical cystectomy for bladder cancer . Patients receiving alvimopan experienced quicker bowel recovery and had a shorter hospital stay compared with those who received placebo , with comparable safety . TRIAL REGISTRATION Clinical Trials.gov identifier NCT00708201 BACKGROUND Reporting methodology is highly variable and nonst and ardized , yet surgical outcomes are utilized in clinical trial design and evaluation of healthcare provider performance . OBJECTIVE We sought to define the type , incidence , and severity of early postoperative morbidities following radical cystectomy ( RC ) using a st and ardized reporting methodology . DESIGN , SETTING , AND PARTICIPANTS Between 1995 and 2005 , 1142 consecutive RCs were entered into a prospect i ve complication data base and retrospectively review ed for accuracy . All patients underwent RC/urinary diversion by high-volume fellowship-trained urologic oncologists . MEASUREMENTS All complications within 90 d of surgery were analyzed and grade d according to the Memorial Sloan-Kettering Cancer Center complication grading system . Complications were defined and stratified into 11 specific categories . Univariate and multivariate regression models were used to define predictors of complications . RESULTS AND LIMITATIONS Sixty-four percent ( 735/1142 ) of patients experienced a complication within 90 d of surgery . Among patients experiencing a complication , 67 % experienced a complication during the operative hospital admission and 58 % following discharge . Overall , the highest grade of complication was grade 0 in 36 % ( n=407 ) , grade 1 - 2 in 51 % ( n=582 ) , and grade 3 - 5 in 13 % ( n=153 ) . Gastrointestinal complications were most common ( 29 % ) , followed by infectious complications ( 25 % ) and wound-related complications ( 15 % ) . The 30-d mortality rate was 1.5 % . CONCLUSIONS Surgical morbidity following RC is significant and , when strict reporting guidelines are incorporated , higher than previously published . Accurate reporting of postoperative complications after RC is essential for counseling patients , combined modality treatment planning , clinical trial design , and assessment of surgical success Objective Optimizing peri‐operative care using an enhanced recovery programme improves short‐term outcomes following colonic resection . This study compared a prospect i ve group of patients undergoing resection of colorectal cancer within an enhanced recovery programme , with a prospect ively studied historic cohort receiving conventional care OBJECTIVE To investigate the efficacy and safety of alvimopan , 12 mg , administered orally 30 to 90 minutes preoperatively and twice daily postoperatively in conjunction with a st and ardized accelerated postoperative care pathway for managing postoperative ileus after bowel resection . DESIGN , SETTING , AND PATIENTS This multicenter , r and omized , placebo-controlled , double-blind , phase 3 trial enrolled adult patients undergoing partial bowel resection with primary anastomosis by laparotomy and scheduled to receive intravenous , opioid-based , patient-controlled analgesia . A st and ardized accelerated postoperative care pathway including early ambulation , oral feeding , and postoperative nasogastric tube removal was used to facilitate gastrointestinal ( GI ) tract recovery in all of the patients . MAIN OUTCOME MEASURES The primary end point was time to GI-2 recovery ( toleration of solid food and first bowel movement ) . Secondary end points included time to GI-3 recovery ( toleration of solid food and first flatus or bowel movement ) , hospital discharge order written , and actual hospital discharge . Postoperative length of hospital stay based on calendar day of hospital discharge order written , opioid consumption , and overall postoperative ileus-related morbidity were recorded . RESULTS Alvimopan , 12 mg , was well tolerated and significantly accelerated GI-2 recovery , GI-3 recovery , and actual hospital discharge compared with a st and ardized accelerated postoperative care pathway alone ( hazard ratio = 1.5 , 1.5 , and 1.4 , respectively ; P < .001 for all ) . Time to hospital discharge order written as measured by hazard ratio ( 1.4 ) and by postoperative calendar days ( mean for alvimopan , 5.2 days ; mean for placebo , 6.2 days ) was also accelerated . Opioid consumption was comparable between groups , and alvimopan was associated with reduced postoperative ileus-related morbidity compared with placebo . CONCLUSIONS Alvimopan , 12 mg , administered 30 to 90 minutes before and twice daily after bowel resection is well tolerated , accelerates GI tract recovery , and reduces postoperative ileus-related morbidity without compromising opioid analgesia Postoperative ileus ( POI ) is a transient loss of coordinated peristalsis precipitated by surgery and exacerbated by opioid pain medication . Ileus causes a variety of symptoms including bloating , pain , nausea , and vomiting , but particularly delays tolerance of oral diet and liquids . Thus POI is a primary determinant of hospital stay after surgery . ‘ Fast-track ’ recovery protocol s , opioid sparing analgesia , and laparoscopic surgery reduce but do not eliminate postoperative ileus . Alvimopan is a mu opioid receptor antagonist that blocks the effects of opioids on the intestine , while not interfering with their central ly mediated analgesic effect . Several large r and omized clinical trials have demonstrated that alvimopan accelerates the return of gastrointestinal function after surgery and subsequent hospital discharge by approximately 20 hours after elective open segmental colectomy . However , it has not been tested in patients undergoing laparoscopic surgery and is less effective in patients receiving nonsteroidal anti-inflammatory agents in a narcotic sparing postoperative pain control regimen . Safety concerns seen with chronic low dose administration of alvimopan for opioid bowel dysfunction have not been noted with its acute use for POI Introduction We sought to evaluate the cost effectiveness of perioperative use of alvimopan in cystectomy and urinary diversion . A recent r and omized controlled trial demonstrated the efficacy of alvimopan in reducing postoperative ileus and length of stay in cystectomy ; however , a major limitation was the exclusion of epidural analgesia . Material s and methods Eighty – six cystectomy and urinary diversion procedures performed by seven surgeons were analyzed between January 2008 and April 2012 . The first 50 patients did not receive alvimopan perioperatively , while the subsequent 36 received a single dose of 12 mg preoperatively and then 12 mg every 12 hours for 15 doses or until discharge . Results The groups were equal with respect to age , gender , indication , surgeon , and type of diversion . Patients who received alvimopan experienced a shorter length of stay ( LOS ) versus those in who did not receive alvimopan ( 10.5 vs. 8.6 days , p = 0.005 , 95 % CI 0.6–3.3 ) . Readmission for ileus was low in both alvimopan and control groups ( 0 % and 4.4 % , respectively ) . Costs were significantly lower in the alvimopan group than the control groups ( 2012 USD 32,443 vs. 40,604 p < 0.001 ) . This difference stood up to multivariate analysis with a $ 7,062 difference in hospital stay . Conclusions Use of alvimopan in the routine perioperative care of our cystectomy and urinary diversion patients has decreased LOS by 1.9 days . Additionally , institution of routine perioperative alvimopan has reduced costs by $ 7,062 per admission ( 20 % reduction ) . This demonstrates a real world application of alvimopan at a moderate volume center Background : Laparoscopic colonic surgery has been cl aim ed to hasten recovery and reduce hospital stay compared with open operation . Recently , enforced multimodal rehabilitation ( fast-track surgery ) has improved recovery and reduced hospital stay in both laparoscopic and open colonic surgery . Since no comparative data between laparoscopic and open colonic resection with multimodal rehabilitation are available , the value of laparoscopy per se is unknown . Methods : In a r and omized , observer- and -patient , blinded trial , 60 patients ( median age 75 years ) underwent elective laparoscopic or open colonic resection with fast-track rehabilitation and planned discharge after 48 hours . Functional recovery was assessed in detail during the first postoperative month . Results : Median postoperative hospital stay was 2 days in both groups , with early and similar recovery to normal activities as assessed by hours of mobilization per day , computerized monitoring of motor activity assessed , pulmonary function , cardiovascular response to treadmill exercise , pain , sleep quality , fatigue , and return to normal gastrointestinal function . There were no significant differences in postoperative morbidity , mortality , or readmissions , although 3 patients died in the open versus nil in the laparoscopic group . Conclusion : Functional recovery after colonic resection is rapid with a multimodal rehabilitation regimen and without differences between open and laparoscopic operation . Further large-scale studies are required on potential differences in serious morbidity and mortality INTRODUCTION Radical cystectomy is associated with significant morbidity and cost , with rates of gastrointestinal complications as high as 30 % . Alvimopan is a mu opioid receptor antagonist that has been shown in r and omized-control trials to accelerate gastrointestinal recovery in patients undergoing bowel resection with primary anastamosis . We report our experience with gastrointestinal recovery for patients undergoing cystectomy with urinary diversion treated with alvimopan and cost benefit associated . MATERIAL S AND METHODS Between January 2008 and October 2012 , 80 patients underwent radical cystectomy with urinary diversion at two institutions . Forty-two patients in our study did not receive alvimopan preoperatively . Thirty-eight patients received perioperative alvimopan and were without postoperative nasogastric decompression . Return of bowel function , initiation of diet , and gastrointestinal complications and estimated cost of hospitalization were evaluated . RESULTS Times to first flatus ( 3.1 days versus 4.7 days , p < 0.01 , 95 % CI 0.96 - 2.24 ) and bowel movement ( 3.9 days versus 4.9 days , p < 0.01 , 95 % CI 0.45 - 1.55 ) were significantly shorter in those patients who received alvimopan . Additionally , the initiation of clear liquid diet ( 4.1 days versus 5.5 days , p < 0.01 , 95 % CI 0.70 - 2.10 ) , regular diet ( 5.2 days versus 6.3 days , p < 0.01 , 95 % CI 0.39 - 1.81 ) and hospital discharge ( 6.1 days versus 7
Output:
| This meta- analysis has shown that alvimopan significantly accelerates recovery of gastrointestinal function and reduces the length of stay in patients performed radical cystectomy . |
MS213948 | ***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 efficacy of clodronate to reduce bone loss around uncemented stems after total hip arthroplasty ( THA ) was evaluated . Ninety-one patients operated with uncemented THA were r and omized to receive either intramuscular clodronate at a dose of 100 mg weekly for 12 months or no treatment . Periprosthetic and contralateral bone mineral density ( BMD ) scans were performed and biochemical markers of bone turnover measured at baseline and at 3 , 6 , and 12 months . At month 12 , with the exception of Gruen zones 4 and 5 , patients treated with clodronate showed less bone loss at all zones , reaching statistical significance ( P < 0.05 ) in Gruen zones 2 and 6 ( difference of 6.6 and 5.9 % , respectively ) . Analysis of data according to gender revealed sex-related differences in bone loss and efficacy of treatment . After 12 months , the difference in bone loss between treated and untreated women in five out of seven Gruen zones ranged from 6.2 to 13.3 % ( SS at zones 2 and 6 ) , whereas comparison between treated and untreated men showed no BMD differences in all zones ( P > 0.05 ) . Median percent changes in serum levels of markers of bone metabolism by gender were consistent with BMD changes . A 1-year treatment with intramuscular clodronate determined a significant reduction of bone loss after THA . This was mainly attributed to its greater efficacy in the female population , which is at higher risk for bone loss . This observation suggests the need for the characterization of high-risk subjects as potential c and i date s for prevention strategies Summary Forty-three patients who had undergone cementless THA were r and omly assigned to receive no osteoactive drug or oral risedronate for 6 months . Postoperative decrease of BMD in the risedronate group was significantly lower than that seen in the control group in zones 1 , 2 , 3 , 6 , and 7 . Introduction Proximal bone resorption around the femoral stem often has been observed after total hip arthroplasty ( THA ) , could lead to late stem loosening . We previously reported the efficacy of etidronate on periprosthetic bone resorption after cementless THA . Recently risedronate is suggested to be effective for the prevention and treatment of for osteoporosis . The purpose of the present study was to evaluate the effects of risedronate on periprosthetic bone loss after cementless THA . Methods Forty-three patients who had undergone cementless THA were r and omly assigned to receive no osteoactive drug ( 21 patients ) or oral risedronate 2.5 mg/day ( 22 patients ) for 6 months . Three patients were eliminated from the risedronate group because of dyspepsia . Periprosthetic bone mineral density ( BMD ) in seven regions of interest based on the zones of Gruen et al. was measured with dual energy X-ray absorptiometry at 3 weeks and 6 months postoperatively . Results At 6 months after surgery , postoperative decrease of BMD in the risedronate group was significantly lower than that seen in the control group in zones 1 , 2 , 3 , 6 , and 7 ( p < 0.05 , p < 0.01 , p < 0.01 , p < 0.05 , and p < 0.05 , respectively ) . Conclusion These outcomes suggested that risedronate might reduce the periprosthetic bone resorption after cementless THA Background and Aims : Periprosthetic bone loss , especially in the proximal part of the femur , is common after cemented and uncemented total hip arthroplasty ( THA ) . Short-term studies suggest that bisphosponates can minimize this bone loss related to stress-shielding phenomenon . The aim of the present r and omized study was to investigate whether the positive effect of a 6 months alendronate treatment postoperatively still exists at five-year follow up . Material s and Methods : Sixteen uncemented primary THA patients were r and omized to receive either 10 mg alendronate + 500 mg calcium ( n = 7 ) or 500 mg calcium only ( n = 9 ) daily for 6 months postoperatively . Periprosthetic bone mineral density ( BMD ) was measured with the dual X-ray absorptiometry ( DXA ) postoperatively and at 6 , 12 , 24 , 36 and 60 months follow-up . Results : At the 5-year follow up , the calcium group showed mean BMD decreases of 23.1 % ( SD 14.6 ) in the proximal part of the femur ( prROI ) and 9.6 % ( SD 14.9 ) in total femoral regions of interest ( totROI ) . In the alendronate group the corresponding BMD decreases were 13.6 % ( SD 19.0 ) and 3.9 % ( SD 7.6 ) respectively . The positive effect of alendronate was already demonstrated during the first six months postoperatively . Subsequently the bone loss was equal in both groups , and the 5-year BMD changes were not significantly different between the groups . Conclusions : Alendronate seems to decrease early periprosthetic bone loss after arthroplasty but this pilot study could not provide enough evidence that the positive effect noted in the early postoperative period is still maintained 5 years after the operation BACKGROUND Bone mineral density decreases after total knee arthroplasty and is believed to affect prosthetic fixation . Treatment with alendronate has been shown to improve short-term bone mineral density after total knee arthroplasty ; however , the long-term effects of this therapy are unknown . The purpose of this study was to evaluate the long-term effects of a six-month course of alendronate on bone mineral density after total knee arthroplasty . METHODS Sixty patients were r and omly assigned to receive either oral alendronate at a dosage of 10 mg/day for six months or no alendronate . The bone mineral density in the distal aspect of the femur and the proximal aspect of the tibia was measured preoperatively and at six , twelve , and thirty-six months after total knee arthroplasty . RESULTS Fifty-four patients ( twenty-nine in the alendronate group and twenty-five in the control group ) completed the study . The alendronate group showed significant increases in bone mineral density in the distal aspect of the femur compared with the controls at six months ( + 4.8 % and -14.2 % , respectively ; p < 0.01 ) and twelve months ( + 1.6 % and -11.5 % , respectively ; p < 0.01 ) . No significant difference in bone mineral density was detected between the groups at thirty-six months ( -3.9 % and -12.2 % , respectively ; p = 0.08 ) . Similar trends in bone mineral density changes were also observed in the proximal aspect of the tibia . CONCLUSIONS A six-month course of alendronate initially increased bone mineral density at six and twelve months after total knee arthroplasty , but no difference was noted after thirty-six months . The effect of alendronate on bone mineral density after total knee arthroplasty may be limited after discontinuation of therapy Acute periprosthetic bone loss occurs after total hip arthroplasty . Bone loss undermines the support of the implant and may contribute to prosthetic failure . At present , there is no established prophylaxis for this process . We studied the effect of a single-dose infusion of 90 mg of pamidronate on early periprosthetic bone mineral density ( BMD ) , biochemical markers of bone turnover , radiological , and clinical outcome in a 26-week , prospect i ve , r and omized , double-blinded study of 47 men and women undergoing total hip arthroplasty . Pamidronate therapy led to a significant reduction in bone loss compared with placebo for both the proximal femur and the pelvis ( repeated measures analysis of variance [ ANOVA ] ) ; p = 0.001 and p = 0.01 , respectively ) . Pamidronate therapy was associated with suppression of all biochemical markers of bone turnover compared with placebo ( repeated measures ANOVA ; p < 0.05 for all comparisons ) , with the exception of urinary free deoxypyridinoline . Pamidronate did not interfere with the clinical improvement in symptoms after total hip arthroplasty , or radiological outcome , and was not associated with an increase in adverse events . This study provides clinical data on the efficacy and safety of bisphosphonates for the prevention of bone loss after total hip arthroplasty and supports the establishment of larger-scale clinical trials to determine the long-term clinical efficacy of this intervention using implant failure as the primary endpoint Periprosthetic bone loss after arthroplasty may threaten prosthesis survival . The current study investigated the effect of etidronate therapy on periprosthetic , contralateral hip , and spine bone mineral density ( BMD ) in a one-year , prospect i ve , r and omized , double-blind study on 46 patients after cemented hip arthroplasty . BMD was measured with dual-energy X-ray absorptiometry ( DXA ) . There were no significant differences between mean BMD measurements of the etidronate and placebo groups , with the exception of the mean percent change in the spine at six months and 12 months and in Gruen zone 3 at six months ; in all three cases , the etidronate group had significantly greater mean values . These findings suggest that cyclic etidronate therapy has no significant effect in suppressing periprosthetic bone loss following cemented hip arthroplasty . RésuméLa perte osseuse périprothétique après arthroplastie peut mettre en danger la survie de la prothèse . Nous avons étudié l'effet de l'étidronate sur la densité minérale ( DM ) de l'os en zone périprothétique , au niveau de la hanche opposée et du rachis . L'étude à un an , prospect i ve , r and omisée et en double-aveugle a inclue 46 malades après arthroplastie de la hanche cimentée . La DM était mesurée par absorptiométrie biphotonique ( DXA ) . En général , il n'y avait pas de différence significative entre la DM moyenne du groupe étidronate et du groupe placebo . Les seules exceptions étaient les changements en pourcentage sur le rachis après 6 et 12 mois et en Zone 3 de Gruen après 6 mois ; dans tous ces cas , le groupe étidronate avait des valeurs moyennes significativement plus gr and es . Ces résultats indiquent que la thérapie cyclique par étidronate n'a pas d'effet significatif pour enrayer la perte osseuse périprothétique après arthroplastie cimentée de la hanche Menopause and increasing age are associated with a decrease in calcium absorption that can contribute to the pathogenesis of osteoporosis . We hypothesized that alendronate plus vitamin D(3 ) ( ALN + D ) would increase fractional calcium absorption ( FCA ) . In this r and omized , double-blind , placebo-controlled multicenter clinical trial , 56 postmenopausal women with 25-hydroxyvitamin D [ 25(OH)D ] concentrations of 25 ng/mL or less and low bone mineral density ( BMD ) received 5 weekly doses of placebo or alendronate 70 mg plus vitamin D(3 ) 2800 IU ( ALN + D ) . Calcium intake was stabilized to approximately 1200 mg/d prior to r and omization . FCA was determined using a dual-tracer stable-calcium isotope method . FCA and 25(OH)D were similar between treatment groups at baseline ( 0.31 ± 0.12 ng/mL and 19.8 ± 4.7 ng/mL , respectively ) . After 1 month of treatment , subjects r and omized to ALN + D experienced a significant least squares ( LS ) mean [ 95 % confidence interval ( CI ) ] increase in FCA [ 0.070 ( 0.042 , 0.098 ) ] , whereas FCA did not change significantly in the placebo group [ -0.016 ( -0.044 , 0.012 ) ] . After ALN + D treatment , patients had higher 25(OH)D levels ( LS mean difference 7.3 ng/mL , p < .001 ) . The rise in serum 1,25-dihydroxyvitamin D(3 ) ( p < .02 ) and parathyroid hormone ( p < .001 ) were greater in the ALN + D group than in placebo-treated patients . ALN + D was associated with an increase in FCA of 0.07 . To our knowledge , there is no other trial showing such a marked rise in calcium absorption owing to treatment with a bisphosphonate or owing to a small rise in 25(OH)D. This unique response of ALN + D is important for the treatment of osteoporosis , but the exact mechanism requires further study Undesired bone loss around implants is considered to occur mainly because of a stress-shielding phenomenon . Bone surrounding the total knee arthroplasty ( TKA ) adjusts its mineral density and structure to meet new mechanical dem and s. Immobilization , in combination with local operative trauma to the bone and soft tissues , has an additional impact on bone loss . The clinical survival of TKA is associated with the quality and quantity of the surrounding bone environment . Poor bone quality and quantity may predispose to aseptic implant loosening and periprosthetic fractures . We investigated the
Output:
| The efficacy was more potent for the second and the third generation of BPs than the first generation .
Conclusions The overall moderate evidence from the RCTs confirmed the significantly short-term and middle-term efficacy of BPs on periprosthetic bone loss after joint arthroplasty . |
MS213949 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
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Input: Background The control of soil-transmitted helminth ( STH ) infections currently relies on the large-scale administration of single-dose oral albendazole or mebendazole . However , these treatment regimens have limited efficacy against hookworm and Trichuris trichiura in terms of cure rates ( CR ) , whereas fecal egg reduction rates ( ERR ) are generally high for all common STH species . We compared the efficacy of single-dose versus triple-dose treatment against hookworm and other STHs in a community-based r and omized controlled trial in the People 's Republic of China . Methodology /Principal findings The hookworm CR and fecal ERR were assessed in 314 individuals aged ≥5 years who su bmi tted two stool sample s before and 3–4 weeks after administration of single-dose oral albendazole ( 400 mg ) or mebendazole ( 500 mg ) or triple-dose albendazole ( 3 × 400 mg over 3 consecutive days ) or mebendazole ( 3 × 500 mg over 3 consecutive days ) . Efficacy against T. trichiura , Ascaris lumbricoides , and Taenia spp . was also assessed . Albendazole cured significantly more hookworm infections than mebendazole in both treatment regimens ( single dose : respective CRs 69 % ( 95 % confidence interval [ CI ] : 55–81 % ) and 29 % ( 95 % CI : 20–45 % ) ; triple dose : respective CRs 92 % ( 95 % CI : 81–98 % ) and 54 % ( 95 % CI : 46–71 % ) ) . ERRs followed the same pattern ( single dose : 97 % versus 84 % ; triple dose : 99.7 % versus 96 % ) . Triple-dose regimens outperformed single doses against T. trichiura ; three doses of mebendazole – the most efficacious treatment tested – cured 71 % ( 95 % CI : 57–82 % ) . Both single and triple doses of either drug were highly efficacious against A. lumbricoides ( CR : 93–97 % ; ERR : all > 99.9 % ) . Triple dose regimens cured all Taenia spp . infections , whereas single dose applications cured only half of them . Conclusions / Significance Single-dose oral albendazole is more efficacious against hookworm than mebendazole . To achieve high CRs against both hookworm and T. trichiura , triple-dose regimens are warranted . Trial Registration www.controlled-trials.com IS RCT A r and omized clinical trial was conducted to compare the effectiveness of albendazole alone and albendazole combined with praziquantel in the treatment of Trichuris trichiura infection . The drug regimens consisted of single dose of albendazole 400 mg ( A1 , n=34 ) , 3 days of albendazole 400 mg daily ( A3 , n=34 ) , 5 days of albendazole 400 mg daily ( A5 , n=35 ) , single dose of albendazole 400 mg plus praziquantel 40 mg/kg ( AIP1 , n=34 ) , and 3 days of albendazole 400 mg plus praziquantel 40 mg/kg daily ( A3P3 , n=36 ) . It was found that treatment with 3 or more consecutive days of albendazole with or without praziquantel result ed in a significant reduction in density of Trichuris eggs in stools while a single dose of such drug did not . Praziquantel was not shown to have synergistic or antagonistic effects with albendazole . A regimen of 400 mg of albendazole daily for 3 days was found to be the most suitable therapy for Trichuris infection The comparative efficacy of albendazole and mebendazole in the treatment of intestinal nematode infections were compared 3 weeks after treatment in a r and omized trial among schoolchildren on Pemba Isl and , Tanzania . Egg counts were compared 3 weeks , 4 months and 6 months after treatment of 731 children seen on each occasion . Differences in the efficacies were apparent with some nematodes 21 d after treatment , but these were no longer apparent 4 months after treatment , and by 6 months intensities of infection were similar to pre-treatment levels . These findings suggest that treatment of schoolchildren every 4 months may be necessary in this highly endemic area in order to have an impact on the intensity of intestinal nematode infections sufficient to be likely to reduce morbidity Background To control soil-transmitted helminth ( STH ) infections , the World Health Organization recommends school-based deworming programs with a health hygiene education component . The effect of such health hygiene interventions , however , has not been adequately studied . The objective of the present study was to determine the effectiveness of a health hygiene education intervention on the occurrence of STH re-infection four months post-de-worming . Methodology /Principal Findings An open-label pair-matched cluster-r and omized trial was conducted in Grade 5 schoolchildren of 18 primary schools ( 9 intervention and 9 control ) in the Peruvian Amazon . Baseline assessment included interview with a pre-tested question naire and collection of single stool specimens that were examined using the single Kato-Katz thick smear . All schoolchildren were then treated with single-dose albendazole ( 400 mg ) . Schoolchildren in intervention schools then received 1 ) an initial one hour in-class activity on health hygiene and sanitation and 30-minute refresher activities every two weeks over four months ; and 2 ) a half-day workshop for teachers and principals , while children in control schools did not . Four months later , STH infection was re-assessed in all schools by laboratory technologists blinded to intervention status . From April 21–October 20 , 2010 , a total of 1,089 schoolchildren ( 518 and 571 from intervention and control schools , respectively ) participated in this study . Intervention children scored significantly higher on all aspects of a test of STH-related knowledge compared with control children ( aOR = 18·4 ; 95 % CI : 12·7 to 26·6 ) . The intensity of Ascaris lumbricoides infection at follow-up was statistically significantly lower ( by 58 % ) in children in intervention schools compared with children in control schools ( aIRR = 0·42 ; 95 % CI = 0·21 to 0·85 ) . No significant changes in hookworm or Trichuris trichiura intensity were observed . Conclusions / Significance A school-based health hygiene education intervention was effective in increasing STH knowledge and in reducing Ascaris lumbricoides infection . The benefits of school-based periodic deworming programs are likely to be enhanced when a sustained health hygiene education intervention is integrated into school curricula BACKGROUND Commonly used drugs for preventive chemotherapy against soil-transmitted helminths ( ie , albendazole and mebendazole ) show low efficacy against Trichuris trichiura . Recent studies with oxantel pamoate revealed good cure rates and high egg-reduction rates against T trichiura . We aim ed to assess the nature of the dose-response relation to determine the optimum dose . METHODS We did a parallel , r and omised , placebo-controlled , single-blind trial with oxantel pamoate in school-aged children ( aged 6 - 14 years ) infected with T trichiura on Pemba Isl and , Tanzania . Children were asked to provide two stool sample s and children positive for T trichiura were eligible to participate in the trial . Children were excluded if they suffered from any systematic illness . Children were r and omly assigned to six different oxantel pamoate doses ( 5 - 30 mg/kg ) or a placebo . R and omisation was stratified by baseline infection intensity using r and om block sizes of seven and 14 . The primary endpoints were cure rates and egg-reduction rates against T trichiura , both analysed by available case . Drug safety was assessed 2 h and 24 h after treatment . The trial is registered at www.is rct n.com , number IS RCT N86603231 . FINDINGS Between Oct 14 , and Nov 28 , 2014 , we enrolled 480 participants and r and omly assigned 350 children to the different oxantel pamoate doses or the placebo . 5 mg/kg oxantel pamoate was the minimum effective dose ( 10 of 46 children cured [ cure rate 22 % , 95 % CI 11 - 36 ] ; egg-reduction rate 85·0 % , 64·5 - 92·9 ) . An increased probability of being cured and reduced egg counts with escalating doses was recorded . At 25 mg/kg oxantel pamoate 27 of 45 children were cured ( cure rate 60 % , 95 % CI 44 - 65 ) with an egg-reduction rate of 97·5 % ( 94·4 - 98·9 ) , and at 30 mg/kg 27 of 46 children were cured ( 59 % , 43 - 73 ) with an egg-reduction rate of 98·8 % ( 96·8 - 99·6 ) . Oxantel pamoate was well tolerated across all treatment groups ; only mild adverse events were reported by the participants 2 h ( 27 [ 10 % ] ) and 24 h ( 12 [ 4 % ] ) after treatment . INTERPRETATION Our dose-finding study revealed an excellent tolerability profile of oxantel pamoate in children infected with T trichiura . An optimum therapeutic dose range of 15 - 30 mg/kg oxantel pamoate was defined . With a weight independent dose of 500 mg oxantel pamoate 95 % of children aged 7 - 14 years in sub-Saharan Africa would receive doses of 11·7 - 32·0 mg/kg . Future research should include studies with oxantel pamoate in younger children and on different continents with the ultimate goal to be able to add oxantel pamoate to soil-transmitted helminth control programmes . FUNDING Swiss National Science Foundation Background The currently used anthelmintic drugs , in single oral application , have low efficacy against Trichuris trichiura infection , and hence novel anthelmintic drugs are needed . Nitazoxanide has been suggested as potential drug c and i date . Methodology The efficacy and safety of a single oral dose of nitazoxanide ( 1,000 mg ) , or albendazole ( 400 mg ) , and a nitazoxanide-albendazole combination ( 1,000 mg–400 mg ) , with each drug administered separately on two consecutive days , were assessed in a double-blind , r and omized , placebo-controlled trial in two schools on Pemba , Tanzania . Cure and egg reduction rates were calculated by per- protocol analysis and by available case analysis . Adverse events were assessed and grade d before treatment and four times after treatment . Principal Findings Complete data for the per- protocol analysis were available from 533 T. trichiura-positive children . Cure rates against T. trichiura were low regardless of the treatment ( nitazoxanide-albendazole , 16.0 % ; albendazole , 14.5 % ; and nitazoxanide , 6.6 % ) . Egg reduction rates were 54.9 % for the nitazoxanide-albendazole combination , 45.6 % for single albendazole , and 13.4 % for single nitazoxanide . Similar cure and egg reduction rates were calculated using the available case analysis . Children receiving nitazoxanide had significantly more adverse events compared to placebo recipients . Most of the adverse events were mild and had resolved within 24 hours posttreatment . Conclusions / Significance Nitazoxanide shows no effect on T. trichiura infection . The low efficacy of albendazole against T. trichiura in the current setting characterized by high anthelmintic drug pressure is confirmed . There is a pressing need to develop new anthelmintics against trichuriasis . Trial Registration Controlled-Trials.com IS RCT Vietnam is participating in a global de-worming effort that aims to treat 650 million school children regularly by 2010 . The treatment used in Vietnam is single dose oral mebendazole ( Phardazone ) 500 mg . We tested the efficacy of single dose mebendazole 500 mg in the therapy of hookworm infection in a r and omized double-blind placebo-controlled trial among 271 Vietnamese schoolchildren . The treatment efficacy of single dose mebendazole in children did not differ significantly from placebo , with a reduction in mean eggs per gram of feces relative to placebo of 31 % ( 95 % CI -9 to 56 % , P = 0.1 ) . In light of these findings we then carried out a similar r and omized trial comparing triple dose mebendazole , single dose albendazole , and triple dose albendazole against placebo in 209 adults in the same area . The estimated reduction in mean post-treatment eggs per gram of feces relative to placebo was 63 % ( 95 % CI 30 - 81 % ) for triple mebendazole , 75 % ( 47 - 88 % ) for single albendazole , and 88 % ( 58 - 97 % )
Output:
| Conclusions All four currently recommended drugs show limitations in their efficacy profile .
While only albendazole showed good efficacy against hookworm infection , all drugs had low efficacy against T trichiura . |
MS213950 | ***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 Motivating adolescents to adopt proper nutrition and physical activity behaviors is important in this nation 's fight to prevent obesity and chronic diseases . This study was conducted to determine which health education delivery method would elicit a greater behavior change . METHOD The intervention was conducted in three schools ( control , computer-based , and traditional education ) . RESULTS Students who received the computer-based intervention showed increased knowledge ( p<0.001 ) , physical activity ( p=0.001 ) , self-efficacy ( p<0.001 ) , and social support ( p<0.001 ) , and decreased meals skipped ( p<0.001 ) . CONCLUSION The computer-based group showed more positive behavior changes . However , future programs may be enhanced by including group discussion and individual feedback Background Age‐related endothelial dysfunction and vascular stiffening are associated with increased cardiovascular ( CV ) risk . Many groups have encouraged goals of ≥10 000 steps/day or ≥30 min/day of moderate intensity physical activity ( MPA ) to reduce age‐related CV risk . The impact of MPA on the vasculature of older adults remains unclear . Methods and Results We r and omized 114 sedentary older adults ages ≥50 to 12 weeks of either no intervention ( group 1 ) , a pedometer‐only intervention ( group 2 ) , or a pedometer with an interactive website employing strategies to increase the adoption of habitual physical activity ( PA , group 3 ) . Endothelial function by brachial flow‐mediated dilation ( FMD% ) , vascular stiffness by tonometry , step‐count by pedometer , and PA intensity/distribution by accelerometer were measured . Step‐count increased in groups 2 ( 5136±1554 to 9596±3907 , P<0.001 ) and 3 ( 5474±1512 to 8167±3111 , P<0.001 ) but not in group 1 ( 4931±1667 to 5410±2410 ) . Both groups 2 and 3 increased MPA ≥30 min/day . Only group 3 increased MPA in continuous bouts of ≥10 minutes ( P<0.001 ) and improved FMD% ( P=0.001 ) . Neither achievement of ≥10 000 steps/day nor ≥30 min/day of MPA result ed in improved FMD% . However , achieving ≥20 min/day in MPA bouts result ed in improved FMD% . No changes in vascular stiffness were observed . Conclusions MPA reverses age‐related endothelial dysfunction , but may require MPA to be performed in bouts of ≥10 minutes duration for ≥20 min/day to be effective . Commonly encouraged PA goals do not guarantee improved endothelial function and may not be as effective in reducing CV risk . Clinical Trial Registration URL : Clinical trials.gov . Unique identifier : NCT‐01212978 BACKGROUND Web-based interventions for weight control could promote more-widespread dissemination of weight-loss opportunities ; however , they remain limited in effectiveness . Incorporating weight-control practice s used by individuals with long-term weight-loss success ( " positive deviants " ) may improve the efficacy of web-based weight control interventions . PURPOSE To evaluate the efficacy of AchieveTogether , a web-based weight-loss intervention for adults based on user-generated weight-loss strategies from successful weight losers . DESIGN In 2009 - 2010 , participants were r and omized to either a 12-week web-based intervention , AchieveTogether , or a wait-list control condition . SETTING / PARTICIPANTS 100 overweight or obese adults participated in the study . INTERVENTION AchieveTogether was design ed to help individuals implement weight control practice s used by others who successfully lost and maintained weight . MAIN OUTCOME MEASURES The primary outcome was change in weight . Secondary outcomes included blood pressure , daily caloric intake , quality of life , and use of weight control practice s. ANCOVA , with adjustment for baseline values on outcome measures , was used to assess differences between groups in primary and secondary outcomes . Statistical analyses were conducted in 2010 - 2011 . RESULTS Most participants were women ( 69.7 % ) and white ( 90.8 % ) , with a mean age of 50.3 years and baseline BMI of 33.2 ; 88 % completed post-program assessment s. Mean weight loss among intervention participants was -1.4 kg ( 95 % CI= -2.2 , -0.5 ) , compared with a mean weight gain of 0.6 kg ( 95 % CI= -0.3 , 1.4 ) in control participants ( p<0.01 ) . CONCLUSIONS User-generated weight-loss practice s from " positive deviants " could promote weight control in web-based interventions ; however , further research is needed to improve program efficacy . TRIAL REGISTRATION This study is registered at Clinical Trials.govNCT00709501 BACKGROUND Given the dramatic increase in adolescent overweight and obesity , models are needed for implementing weight management treatment through readily accessible venues . We evaluated the acceptability and efficacy of a school-based intervention consisting of school nurse-delivered counseling and an afterschool exercise program in improving diet , activity , and body mass index ( BMI ) among overweight and obese adolescents . METHODS A pair-matched cluster-r and omized controlled school-based trial was conducted in which 8 public high schools were r and omized to either a 12-session school nurse-delivered cognitive-behavioral counseling intervention plus school-based after school exercise program , or 12-session nurse contact with weight management information ( control ) . Overweight or obese adolescents ( N = 126 ) completed anthropometric and behavioral assessment s at baseline and 8-month follow-up . Main outcome measures included diet , activity , and BMI . Mixed effects regression models were conducted to examine differences at follow-up . RESULTS At follow-up , students in intervention compared with control schools were not different in BMI , percent body fat , and waist circumference . Students reported eating breakfast ( adjusted mean difference 0.81 days ; 95 % confidence interval [ CI ] 0.11 - 1.52 ) on more days/week ; there were no differences in other behaviors targeted by the intervention . CONCLUSIONS While a school-based intervention including counseling and access to an after-school exercise program is theoretically promising with public health potential , it was not effective in reducing BMI or key obesogenic behaviors . Our findings are important in highlighting that interventions targeted at the individual level are not likely to be sufficient in addressing the adolescent obesity epidemic without changes in social norms and the environment Background : Theory-based interventions accessible to large groups of people are needed to induce favorable shifts in health behaviors and body weight . Purpose : The aim was to assess nutrition ; physical activity ; and , secondarily , body weight in the tailored , social cognitive Guide to Health ( GTH ) Internet intervention delivered in churches . Methods : Participants ( N=1,071 ; 33 % male , 23 % African American , 57 % with body mass index ≥25 , 60 % sedentary , Mdn age=53 years ) within 14 Baptist or United Method ist churches were r and omized to the GTH intervention only ( GTH-Only ; 5 churches ) , with church-based supports ( GTH-Plus ; 5 churches ) , or to a waitlist ( control ; 4 churches ) . Verified pedometer step counts , measured body weight , fat , fiber , and fruit and vegetable ( F&V ) servings from food frequency and supermarket receipts were collected at pretest , posttest ( 7 months after pretest ) , and follow-up ( 16 months after pretest ) . Results : Participants in GTH-Only increased F&V at post ( ∼1.50 servings ) compared to control ( ∼0.50 servings ; p=.005 ) and at follow-up ( ∼1.20 vs. ∼0.50 servings ; p=.038 ) and increased fiber at post ( ∼3.00 g ) compared to control ( ∼1.5 g ; p=.006 ) and follow-up ( ∼3.00 g vs. ∼2.00 g ; p=.040 ) . GTH-Plus participants compared to control increased steps at post ( ∼1,500 steps/day vs. ∼400 steps/day ; p=.050 ) and follow-up ( ∼1,000 steps/day vs. ∼−50 steps/day ; p=.010 ) , increased F&V at post ( ∼1.5 servings ; p=.007 ) and follow-up ( ∼1.3 servings ; p=.014 ) , increased fiber at post ( ∼3.00 g ; p=.013 ) , and follow-up ( ∼3.00 ; p=.050 ) and decreased weight at post ( ∼−0.30 kg vs. ∼+0.60 kg ; p=.030 ) . Conclusions : Compared to control , both GTH treatments improved nutrition at posttest , but church supports improved physical activity and nutrition at posttest and follow-up , suggesting environmental supports may improve Internet-based interventions Context : Menopausal-related weight gain and increased waist circumference have major cardiovascular health implication s for older women . The efficacy of a dietary and physical activity lifestyle intervention to prevent weight gain and elevations in cardiovascular disease ( CVD ) risk factors from the peri- to postmenopause is unknown . Objective : To report the 54-month results of a lifestyle dietary and physical activity program on weight , body composition , physical activity , diet , and other CVD risk factors . Design : Data are from a 5-year r and omized clinical trial known as the Women ’s Healthy Lifestyle Project , conducted from 1992 to 1999 . Participants : 535 healthy , premenopausal women ages 44 to 50 at study entry enrolled into the trial . Intervention : Participants were r and omly assigned to either a lifestyle intervention group receiving a 5-year behavioral dietary and physical activity program or to an assessment -only control group . The lifestyle intervention group was given modest weight loss goals ( 5–15 lb , or approximately 2.3–6.8 kg ) to prevent subsequent gain above baseline weight by the end of the trial . To achieve weight loss and lower low-density lipoprotein cholesterol levels , intervention participants followed an eating pattern consisting of 1,300 kcal/day ( 25 % total fat , 7 % saturated fat , 100 mg of dietary cholesterol ) and increased their physical activity expenditure ( 1,000–1,500 kcal/week).Main Outcome Measures : Regarding weight gain prevention , 55 % ( 136/246 ) of intervention participants were at or below baseline weight compared with 26 % ( 68/261 ) of controls after 4.5 years , χ(2 , N = 507 ) = 45.0 , p < .001 . The mean weight change in the intervention group was 0.1 kg below baseline ( SD = 5.2 kg ) compared with an average gain of 2.4 kg ( SD = 4.9 kg ) observed in the control group . Waist circumference also significantly decreased more in the intervention group compared with controls ( M = −2.9 cm , SD = 5.3 vs. M = −0.5 cm , SD = 5.6 , p < .001 ) . Moreover , participants in the lifestyle intervention group were consistently more physically active and reported eating fewer calories and less fat than controls . Long-term adherence to physical activity and a low-fat eating pattern was associated with better weight maintenance . Conclusions : In healthy women , weight gain and increased waist circumference during the peri- to postmenopause can be prevented with a long-term lifestyle dietary and physical activity intervention 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 Importance Strategies to improve the nutritional status of those participating in the Supplemental Nutrition Assistance Program
Output:
| Few areas demonstrated statistically significant effects across studies ; school‐based approaches and health care initiatives reduced energy consumed , education reduced energy consumed and increased energy expended , and social‐group approaches increased energy expenditure .
Conclusions Despite the amount of research on obesity prevention interventions , very few studies have provided relevant information on energy intake and expenditure , two factors determining weight gain . |
MS213951 | ***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 To investigate whether dexmedetomidine infusion could reduce opioid consumption and opioid-related side effects after uterine artery embolization ( UAE ) . MATERIAL S AND METHODS Fifty patients undergoing UAE for symptomatic leiomyomas or adenomyosis were r and omized into two groups . In 25 patients , dexmedetomidine infusion was started at 0.2 μg/kg/h at 30 minutes before the procedure , followed by 0.4 μg/kg/h for 6 hours after the procedure . In another 25 patients ( control group ) , volume-matched normal saline solution was administered . Both groups received fentanyl-based intravenous patient-controlled analgesia ( PCA ; fentanyl 10 μg/h with a bolus dose of 20 μg ) during the 24 hours after the procedure . Nonspherical polyvinyl alcohol particles were used . Pain scores , fentanyl consumption , need for additional analgesics , and side effects were assessed for 24 hours after UAE . RESULTS Compared with the control group , patients in the dexmedetomidine group required 28 % less PCA fentanyl during the 24 hours after UAE ( P = .006 ) . Numeric rating scale scores for pain ( 5.0±2.4 vs 7.0±2.2 ; P = .026 ) and the need for additional analgesics ( two of 25 vs 17 of 25 ; P<.001 ) were lower in the dexmedetomidine group than in the control group during the first 1 hour after UAE . The incidence and severity of nausea and vomiting during the 24 hours after UAE were lower in the dexmedetomidine group than in the control group ( P < .05 ) . CONCLUSIONS The addition of dexmedetomidine infusion to fentanyl PCA provides better analgesia , fentanyl-sparing effect , and less nausea and vomiting , without significant hemodynamic instability PURPOSE To assess the efficacy of the superior hypogastric nerve block ( SHNB ) in permitting uterine artery embolization ( UAE ) to be performed as a routine outpatient procedure . MATERIAL S AND METHODS One hundred thirty-nine patients who underwent UAE in a prospect i ve single-arm clinical trial in an academic institution underwent SHNB from an anterior abdominal approach to control acute postprocedural pain , in addition to conventional conscious sedation . They were discharged and prescribed one of two drug combinations started during the in-hospital recovery period . Regimen A included short-acting morphine tablets and indomethacin rectal suppositories and regimen B included long-acting morphine tablets for baseline pain supplemented with short-acting morphine tablets for breakthrough pain , and naproxen rectal suppositories . All patients were contacted by phone on the third and fifth postprocedural days and their peak pain experience was recorded on a scale of 0 to 10 . RESULTS All patients were able to be discharged the day of the procedure . Seven patients ( 5 % ) returned to the hospital because of pain . One was discharged after undergoing a second SHNB and four were discharged after receiving intravenous analgesics ; two required longer admission for intravenous analgesia . The mean ( + /-SD ) peak pain score in the first 5 days after the procedure for all patients was 4.8 + /- 2.6 . There was a significant difference between regimens A ( mean pain score , 5.7 + /- 2.2 ) and B ( mean pain score , 2.7 + /- 2.5 ; Mann-Whitney , 5.94 ; P < .01 ) . CONCLUSION The addition of SHNB to the more conventional post-UAE pain management methodology enhances pain control , enabling the procedure to be offered with minimum pain on a routine outpatient basis PURPOSE To evaluate whether it is safe to perform uterine artery embolization ( UAE ) as an outpatient procedure . MATERIAL S AND METHODS This retrospective study was approved by the institutional review board and included 234 patients ( age range , 24 - 58 years ; mean age , 40.5 years ) who underwent UAE as an outpatient procedure with polyvinyl alcohol particles between January 2007 and March 2008 . Patients were given acid-suppressing drugs , nonsteroidal anti-inflammatory drugs , anti-histaminic drugs , and laxatives twice on the day before UAE and once on the morning of UAE . Pain score , rated from 0 to 10 , was evaluated by using a numeric pain scale during UAE , after the procedure , at discharge , at the night of discharge , and on the following morning . The outcome of UAE was evaluated at 6 months by means of pelvic magnetic resonance imaging and clinical observation . RESULTS The mean pain score was 0.9 during embolization , 2.5 4 - 8 hours after embolization , 0.9 at discharge , 1.1 the first night after discharge , and 0.7 the next morning . All patients were discharged from the hospital 4 - 8 hours after the procedure , with no overnight hospital admissions . At 6 months , 146 of 158 patients ( 92.4 % ) reported an improvement in menorrhagia , 39 of 44 ( 88.6 % ) reported an improvement in bulk symptoms , and 20 of 25 ( 80 % ) reported an improvement in pain . The volumes of the uterus and the dominant fibroid decreased 33.7 % and 39.3 % , respectively . CONCLUSIONS With acid-suppressing , anti-inflammatory , and anti-histaminic drugs started on the day before UAE , the procedure can be performed safely as an outpatient procedure The purpose of this study was to assess the presence and severity of pain levels during 24 h after uterine fibroid embolization ( UFE ) for symptomatic leiomyomata and compare the effectiveness and adverse effects of morphine patient-controlled analgesia ( PCA ) versus fentanyl PCA . We carried out a prospect i ve , nonr and omized study of 200 consecutive women who received UFE and morphine or fentanyl PCA after UFE . Pain perception levels were obtained on a 0–10 scale for the 24-h period after UFE . Linear regression methods were used to determine pain trends and differences in pain trends between two groups and the association between pain scores and patient covariates . One hundred eighty-five patients ( 92.5 % ) reported greater-than-baseline pain after UFE , and 198 patients ( 99 % ) required IV opioid PCA . One hundred thirty-six patients ( 68.0 % ) developed nausea during the 24-h period . Seventy-two patients ( 36 % ) received morphine PCA and 128 ( 64 % ) received fentanyl PCA , without demographic differences . The mean dose of morphine used was 33.8 ± 26.7 mg , while the mean dose of fentanyl was 698.7 ± 537.4 μg . Using this regimen , patients who received morphine PCA had significantly lower pain levels than those who received fentanyl PCA ( p < 0.0001 ) . We conclude that patients develop pain requiring IV opioid PCA within 24 h after UFE . Morphine PCA is more effective in reducing post – uterine artery embolization pain than fentanyl PCA . Nausea is a significant adverse effect from opioid PCA BACKGROUND Post-procedural pain control after uterine artery embolization ( UAE ) of urethral leiomyomata remains a major problem . METHODS This double-blind , r and omized study tested the possibility to obtain a quicker onset of analgesia by using effect-compartment controlled remifentanil patient-controlled analgesia ( remifentanil TCI-PCA ) than by using i.v . morphine PCA . Both systems were connected to an i.v . catheter . Active drug or matching placebo administration was activated by a single push-button . Pain was assessed using a numerical rating scale ( NRS ) from 0 to 10 . RESULTS NRS values were lower in the remifentanil group ( with a possible difference from two to seven points on the scale ) during the initial 4 h post-embolization . After the fourth hour , the NRS values were identical between the groups . No major respiratory or haemodynamic side-effect was observed . CONCLUSIONS Remifentanil PCA-TCI with a slow and progressive adapted algorithm without any associated premedication or co-medication is feasible in young healthy women undergoing UAE & NA ; Twenty‐six patients with extensive gynecologic , colorectal or genitourinary cancer who suffered uncontrolled , incapacitating pelvic pain were enrolled in this study during a 1‐year period . All the patients receiving oral opioids who developed poor pain response due to the progression of disease or untoward side effects necessitating other modes of therapy were eligible to participate . Bilateral percutaneous neurolytic superior hypogastric plexus blocks with 10 % phenol were performed in every patient , 1 day after receiving successful diagnostic blocks using 0 . 25 % bupivacaine ( BUP ) . All patients reported a visual analog pain score ( VAPS ) of 10 of 10 before the block . Eighteen patients ( 69 % ) had satisfactory pain relief ( VAPS < 4 of 10 ) : 15 ( 57 % ) after 1 block and 3 ( 12 % ) after a second block . The remaining 8 patients ( 31 % ) had moderate pain control ( VAPS 4–7 of 10 ) after 2 blocks and received epidural bupivacaine‐morphine ( BUP‐MS ) therapy with good results . Both groups experienced significant reductions in oral opioid therapy after the neurolytic blocks . No additional blocks were required by patients who had a good response during a follow‐up period of 6 months . No complications related to the block were experienced by any patient . In conclusion , neurolytic superior hypogastric plexus block was both effective in relieving pain in 69 % of the patients studied ( 95 % confidence interval of 48–85 % ) . Additional neurolytic blocks using higher volumes of the neurolytic agent may be needed in patients with extensive retroperitoneal disease , a group in whom moderate or poor results should be expected PURPOSE Uterine artery embolization ( UAE ) is gaining popularity as an alternative to hysterectomy for the treatment of fibroids . Although minimally invasive treatments such as UAE offer the potential of fewer complications , shorter hospital stay , and quicker recovery than surgery , there have been few published data on tolerance and recovery in patients undergoing UAE . MATERIAL S AND METHODS This was a multicenter prospect i ve single-arm clinical treatment trial involving the practice s of 11 interventional radiologists in eight Ontario university-affiliated and community hospitals . Between November 1998 and November 2000 , 555 women underwent UAE for symptomatic uterine fibroids . Follow-up included ultrasound examinations and telephone interviews . UAE was performed under conscious sedation . Polyvinyl alcohol particles ( 355 - 500 micro m ) were the primary embolic agent , and the procedural endpoint involved stasis in the uterine arteries . Pain protocol s included antiinflammatory medications and narcotics and a planned overnight hospital admission . Tolerance and recovery were measured by patient-reported pain intensity ( 10-point numeric rating and five-point descriptor scale ) , hospital length of stay ( LOS ) , and time until return to work . RESULTS Intraprocedural pain was reported by 30 % of patients and postprocedural pain was reported by 92 % of patients ( mean pain rating + /- SD , 7.0 + /- 2.47 ) . The mean hospital LOS was 1.3 nights . Postprocedural pain was the most common indication for an LOS greater than 1 night ( 18 % ) or 2 nights ( 5 % ) . Return visits to the hospital ( 10 % ) and readmissions ( 3 % ) were primarily for pain . The overall postprocedural complication rate was 8.0 % ( 95 % CI : 5.9%-10.6 % ) . Of the 44 complications , 32 ( 73 % ) were pain-related . The mean recovery time after UAE was 13.1 days ( median , 10.0 d ) . CONCLUSION The majority of patients had a 1-night LOS after UAE and recovered within 2 weeks . Postprocedural pain varied considerably and was the major indication for extended hospital stay and recovery Abstract When compared in a uterine artery embolization ( UAE ) animal model , Embospheres ( ES ) ( Biosphere Medical , Rockl and , MA ) were found to induce less uterine ischemia than polyvinyl alcohol ( PVA ) particles . Given this finding , we aim ed to test the hypothesis that ES is associated with less pain after UAE than PVA in human patients . We performed retrospective analysis on data from 72 consecutive UAE patients , collected from a prospect ively acquired data base . Patient-controlled analgesia ( PCA ) pump-delivered morphine sulfate ( MS ) dosages were compared between patients who received ES versus PVA . Subjective pain scores ( SPS ) were also compared between the two groups . Secondary outcome measures , including embolic volume and clinical outcome data , were also collected . Linear regression and t-test statistical analyses were performed . Null hypotheses were rejected at the p < 0.05 level . Mean follow-up period in the PVA population was 178 days ( range 28–426 ) , versus 96 days ( range 24–197 ) in the ES
Output:
| There is no evidence to suggest that there is any superiority of one protocol above another in the published literature .
Appropriate use of opioids ± NSAIDs ± acetaminophen alone appears to be sufficient to control pain post-UFE . |
MS213952 | ***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: In the Sh and ong Intervention Trial , 2 weeks of antibiotic treatment for Helicobacter pylori reduced the prevalence of precancerous gastric lesions , whereas 7.3 years of oral supplementation with garlic extract and oil ( garlic treatment ) or vitamin C , vitamin E , and selenium ( vitamin treatment ) did not . Here we report 14.7-year follow-up for gastric cancer incidence and cause-specific mortality among 3365 r and omly assigned subjects in this masked factorial placebo-controlled trial . Conditional logistic regression was used to estimate the odds of gastric cancer incidence , and the Cox proportional hazards model was used to estimate the relative hazard of cause-specific mortality . All statistical tests were two-sided . Gastric cancer was diagnosed in 3.0 % of subjects who received H pylori treatment and in 4.6 % of those who received placebo ( odds ratio = 0.61 , 95 % confidence interval = 0.38 to 0.96 , P = .032 ) . Gastric cancer deaths occurred among 1.5 % of subjects assigned H pylori treatment and among 2.1 % of those assigned placebo ( hazard ratio [ HR ] of death = 0.67 , 95 % CI = 0.36 to 1.28 ) . Garlic and vitamin treatments were associated with non-statistically significant reductions in gastric cancer incidence and mortality . Vitamin treatment was associated with statistically significantly fewer deaths from gastric or esophageal cancer , a secondary endpoint ( HR = 0.51 , 95 % CI = 0.30 to 0.87 ; P = .014 ) BACKGROUND To reduce cancer mortality , effective screening should be implemented properly . In Japan , the Research Group for Cancer Screening developed screening guidelines ; however , the development process was not well established . METHODS Based on the development processes of other guidelines , an original method , unique to Japan , was established to develop the Japanese cancer screening guidelines . RESULTS The guideline development process involved the following steps : topic selection , development of the analytic framework , systematic literature review , translation to recommendations , consultation and publication . Mortality reduction related to cancer screening was evaluated using both direct and indirect evidence . To select appropriate articles , an analytic framework for cancer screening program with key questions was developed . Direct evidence was defined as a single body of evidence that established the linkage between screening and health outcomes such as mortality and incidence . The use of indirect evidence to determine the level of evidence was limited to situations where test accuracy could be compared with that of a method whose evidence was supported by r and omized , controlled trials . Eight levels of evidence were defined based on the study design and quality . The benefits of each screening modality were determined based on the level of evidence according to the results of the systematic review . Balancing the benefits and harms , five grade s of recommendation were formulated for population -based and opportunistic screening . After organized consultations , three types of guidelines were published . CONCLUSION We developed a unique , st and ardized method for developing cancer screening guidelines in Japan . Based on this process , previously developed cancer screening guidelines have been revised BACKGROUND A causal relationship between Helicobacter pylori infection and gastric cancer has been established . A nonr and omized study has shown eradication of H. pylori after endoscopic resection ( ER ) of early gastric cancer inhibits development of new carcinomas . SUBJECTS AND METHODS Eligible subjects are patients with H. pylori infection who are newly diagnosed with early gastric cancer and plan to have ER or who are in the post-resection follow-up phase after ER time of enrollment . Patients are r and omly allocated to the eradication or the control arms ( no eradication and st and ard of care ) . Patients will be evaluated by endoscopy at 0.5 , 1 , 2 , and 3 years after r and omization . Diagnosis of a new carcinoma at another site of the stomach is defined as primary endpoint , and recurrence of tumors at the resection site as a secondary endpoint . In addition to intention-to-treat and per- protocol analyses using proportional hazards models , time to recurrence will be compared between treatment and control using multiple logistic regression analyses . In the latter two situations , the models will be adjusted for the factors exerting significant influences on the results . RESULTS Five hundred and forty-two subjects have been enrolled into the study and are being followed-up . CONCLUSIONS This study will have the statistical power to demonstrate whether H. pylori eradication therapy exerts any clinical ly relevant inhibitory effects on occurrence or recurrence of gastric cancer . In addition , it will be able to test the hypothesis that H. pylori infection is a promoter in gastric carcinogenesis Objective Helicobacter pylori infection and overexpression of cyclo-oxygenase-2 ( COX-2 ) are associated with gastric cancer and its precursors . To evaluate the effect of a selective COX-2 inhibitor alone and combined with H pylori eradication on the evolution of precancerous gastric lesions , a r and omised , placebo-controlled trial was conducted in Linqu County , Sh and ong Province , China . Methods A total of 1024 participants aged 35–64 years with H pylori infection and advanced gastric lesions were r and omly assigned in a factorial design to two interventions or placebo : anti-H pylori treatment for 7 days , and a COX-2 inhibitor ( celecoxib ) for 24 months . The effects of the interventions were evaluated by the regression or progression of advanced gastric lesions . Results Of the 1024 participants who received anti-H pylori treatment or placebo , 919 completed a subsequent 24-month treatment with celecoxib or placebo . The H pylori eradication rate by per- protocol analysis was 78.2 % . Compared with placebo , the proportions of regression of gastric lesions significantly increased in the celecoxib treatment ( 52.8 % vs 41.2 % ) and anti-H pylori treatment ( 59.3 % vs 41.2 % ) group , and OR by per- protocol analysis was 1.72 ( 95 % CI 1.07 to 2.76 ) for celecoxib and 2.19 ( 95 % CI 1.32 to 3.64 ) for H pylori eradication . No statistically significant effect was found for H pylori eradication followed by celecoxib on the regression of advanced gastric lesions ( OR 1.48 , 95 % CI 0.91 to 2.40 ) . Conclusion This population -based intervention trial revealed that celecoxib treatment or H pylori eradication alone had beneficial effects on the regression of advanced gastric lesions . No favourable effects were seen for H pylori eradication followed by celecoxib treatment . Trial registration HARECCTR0500053 in accordance with WHO ICTRP requirements OBJECTIVES : Helicobacter pylori causes gastric adenocarcinoma . We assessed the success of H. pylori eradication therapy in a medically underserved population in Chiapas , Mexico , that is at high risk for gastric cancer risk . METHODS : Healthy volunteers with both antibodies to CagA and gastrin levels ≥25 ng/ml were r and omly assigned to receive either a combination of omeprazole , amoxicillin , and clarithromycin or matched placebo for 1 wk . Endoscopy with seven biopsies was performed at baseline , at 6 wk , and 1 yr after treatment . Treatment success was defined as loss of H. pylori by histological analysis . Cure was assessed using change in serology based on the st and ardized absorbance of a H. pylori ELISA . RESULTS : H. pylori eradication rates were high ( intent-to-treat analysis : 76.3 % [ 95 % CI = 68.7–84.0 % ] after 6 wk and 76.1 % [ 95 % CI = 67.7–84.6 % ] after 1 yr ; per protocol analysis : 77.8 % [ 95 % CI = 70.1–85.4 % ] after 6 wk and 75.2 % [ 95 % CI = 66.5–84.0 % ] after 1 yr ) . Nine subjects on active treatment and one subject on placebo who were without H. pylori at 6 wk were infected at 1 yr ( recurrence rates 10.7 % and 33.3 % , respectively , p = 0.31 ) . Median changes in st and ardized absorbance at 1 yr were 47 % and 1 % for successfully and unsuccessfully treated patients , respectively . A 10 % decline in st and ardized absorbance after 1 yr had 84 % sensitivity and 100 % specificity for H. pylori eradication . CONCLUSIONS : Even with a short course of treatment against H. pylori , a high rate of eradication rate can be achieved in population s at high risk for stomach cancer . Serum antibodies are useful in assessing efficacy of therapy CONTEXT Although chronic Helicobacter pylori infection is associated with gastric cancer , the effect of H pylori treatment on prevention of gastric cancer development in chronic carriers is unknown . OBJECTIVE To determine whether treatment of H pylori infection reduces the incidence of gastric cancer . DESIGN , SETTING , AND PARTICIPANTS Prospect i ve , r and omized , placebo-controlled , population -based primary prevention study of 1630 healthy carriers of H pylori infection from Fujian Province , China , recruited in July 1994 and followed up until January 2002 . A total of 988 participants did not have precancerous lesions ( gastric atrophy , intestinal metaplasia , or gastric dysplasia ) on study entry . INTERVENTION Patients were r and omly assigned to receive H pylori eradication treatment : a 2-week course of omeprazole , 20 mg , a combination product of amoxicillin and clavulanate potassium , 750 mg , and metronidazole , 400 mg , all twice daily ( n = 817 ) ; or placebo ( n = 813 ) . MAIN OUTCOME MEASURES The primary outcome measure was incidence of gastric cancer during follow-up , compared between H pylori eradication and placebo groups . The secondary outcome measure was incidence of gastric cancer in patients with or without precancerous lesions , compared between the 2 groups . RESULTS Among the 18 new cases of gastric cancers that developed , no overall reduction was observed in participants who received H pylori eradication treatment ( n = 7 ) compared with those who did not ( n = 11 ) ( P = .33 ) . In a subgroup of patients with no precancerous lesions on presentation , no patient developed gastric cancer during a follow-up of 7.5 years after H pylori eradication treatment compared with those who received placebo ( 0 vs 6 ; P = .02 ) . Smoking ( hazard ratio [ HR ] , 6.2 ; 95 % confidence interval [ CI ] , 2.3 - 16.5 ; P<.001 ) and older age ( HR , 1.10 ; 95 % CI , 1.05 - 1.15 ; P<.001 ) were independent risk factors for the development of gastric cancer in this cohort . CONCLUSIONS We found that the incidence of gastric cancer development at the population level was similar between participants receiving H pylori eradication treatment and those receiving placebo during a period of 7.5 years in a high-risk region of China . In the subgroup of H pylori carriers without precancerous lesions , eradication of H pylori significantly decreased the development of gastric cancer . Further studies to investigate the role of H pylori eradication in participants with precancerous lesions are warranted BACKGROUND & AIMS : Helicobacter pylori eradication improves the prognosis of peptic ulcer disease ( PUD ) , dyspepsia , and possibly gastric cancer . H pylori screening tests are accurate and eradication therapy is effective . H pylori population screening seems attractive . The aim of this study was to evaluate the long‐term effect of H pylori population screening and eradication on dyspepsia prevalence and the incidence of PUD , and as secondary outcomes to assess the effect on health care consumption and quality of life . METHODS : At baseline in 1998 to 1999 , 20,011 individuals aged 40 to 65 years were r and omized to H pylori screening and eradication or a control group with no screening . Both groups received a question naire on dyspepsia and quality of life . Register data were obtained for all r and omized individuals . RESULTS : The baseline question naire response rate was 63 % . Of the 5749 individuals screened , 1007 ( 17.5 % ) were H pylori positive . Complete symptom data were obtained for 8658 ( 69 % ) individuals after 13 years . Dyspepsia prevalence decreased in both groups during the follow‐up period , but multivariate analysis showed no effect of H pylori screening and eradication ( adjusted odds ratio , 0.93 ; 95 % confidence interval , 0.82–1.04 ) ; compared with usual care . Intention‐to‐treat and per‐ protocol analyses of register data provided similar results . H pylori screening neither reduced PUD incidence significantly ( adjusted odds ratio , 0.88 ; 95 % confidence interval , 0.70−1
Output:
| There is insufficient evidence to support or refute the effectiveness of eradication therapy in preventing gastric carcinoma in H. pylori-infected , high-risk population s. Rigorously conducted large RCTs of healthy infected adults only would provide evidence of the true efficacy of successful eradication . |
MS213953 | ***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: Even though robotic technology holds great potential for performing spinal surgery and advancing neurosurgical techniques , it is of utmost importance to establish its practicality and to demonstrate better clinical outcomes compared with traditional techniques , especially in the current cost-effective era . Several systems have proved to be safe and reliable in the execution of tasks on a routine basis , are commercially available , and are used for specific indications in spine surgery . However , workflow , usability , interdisciplinary setups , efficacy , and cost-effectiveness have to be proven prospect ively . This article includes a short description of robotic structures and workflow , followed by preliminary results of a r and omized prospect i ve study comparing conventional free-h and techniques with routine spine navigation and robotic-assisted procedures . Additionally , we present cases performed with a spinal robotic device , assessing not only the accuracy of the robotic-assisted procedure but also other factors ( eg , minimal invasiveness , radiation dosage , and learning curves ) . Currently , the use of robotics in spinal surgery greatly enhances the application of minimally invasive procedures by increasing accuracy and reducing radiation exposure for patients and surgeons compared with st and ard procedures . Second-generation hardware and software up grade s of existing devices will enhance workflow and intraoperative setup . As more studies are published in this field , robot-assisted therapies will gain wider acceptance in the near future Study Design . A retrospective chart review was performed for 112 consecutive minimally invasive spinal surgery patients who underwent pedicular screw fixation in a community hospital setting . Objective . To assess the clinical accuracy and deviation in screw positions in robot-assisted pedicle screw placement . Summary of Background Data . Accuracy of pedicle screw placement in in vivo studies varies widely , especially when minimally invasive techniques are used . Robotic guidance was recently introduced to increase screw placement accuracy but still reported accuracies vary . Methods . Reproducibility of the surgeon 's plan using robotic guidance was assessed by fusing individual vertebras from the preoperative computed tomography ( CT ) containing the planning with a postoperative CT . Deviation in entry point and difference in angle of insertion was measured on axial and sagittal planes . Grading of pedicle screw placement was performed on postoperative CTs using the Gertzbein-Robbins classification . Results . CT-to-CT fusion succeeded for 178 screws , but these appeared to be r and om , with no apparent selection bias . Mean deviation in entry point was 2.0 ± 1.2 mm . Mean difference in angle of insertion was 2.2 ° ± 1.7 ° on the axial plane and 2.9 ° ± 2.4 ° on the sagittal plane . Assessment of pedicle screw accuracy showed that 477 of 487 screws ( 97.9 % ) were safely placed ( < 2 mm , category A+B ) , 8 screws in category C and 1 in category D. None of the screws necessitated resurgery for revised placement . Conclusion . Preoperative planning of robotic guidance is reproduced intraoperatively within acceptable deviations . We conclude that robotic guidance allows for highly accurate execution of the preoperative plan , leading to accurate screw placement . Level of Evidence : Study Design : This is a prospect i ve r and omized comparison study between the fluoroscopy-guided and navigation coupled with O-arm – guided pedicle screw placement in the thoracic and lumbosacral spines . Objective : The objective of the study was to evaluate the accuracy and clinical benefits of a navigation coupled with O-arm – guided method in the thoracic and lumbar spines by comparing with a C-arm fluoroscopy-guided method . Methods : Under fluoroscopy guidance , 138 pedicle screws were inserted from T9 to S1 in 20 patients , and 124 pedicle screws were inserted from T9 to S1 in 20 patients using the navigation . The position of the screws within the pedicle was assessed from grade 0 ( no violation cortex ) to grade 3 ( > 4 mm violation ) , and the location of the violated cortex was determined . Preparation time of each equipment setting , time for screwing , and the number of x-ray shots were evaluated . Results : The number of screws observed as grade 0 was 121 ( 87.7 % ) in the fluoroscopy-guided group and 114 ( 91.9 % ) in the navigation-guided group . The lateral cortex was most commonly involved in the fluoroscopy-guided group ( 6 cases , 35.3 % ) , and the medial cortex was most common in the navigation-guided group ( 4 cases , 40 % ) . The mean time required for preparation for screw placement was 3.7 minutes in the fluoroscopy-guided group and 14.2 minutes in the navigation-guided group . Average screwing time was 3.6 minutes in the fluoroscopy-guided group and 4.3 minutes in the navigation-guided group . The mean number of x-ray shots for each screw placement in the fluoroscopy-guided group was 6.5 . Postoperatively , 2 patients with misplacement of a screw under fluoroscopy guidance presented ipsilateral leg paresthesia , possibly related to the screw position . Conclusions : The present prospect i ve study reveals that the pedicle screw placement guided by the navigation coupled with O-arm system was more accurate and safer than that under fluoroscopy guidance Abstract This purpose of this retrospective study is validation of an intraoperative robotic grading classification system for assessing the accuracy of Kirschner-wire ( K-wire ) placements with the postoperative computed tomography (CT)-base classification system for assessing the accuracy of pedicle screw placements . We conducted a retrospective review of prospect ively collected data from 35 consecutive patients who underwent 176 robotic assisted pedicle screws instrumentation at Kaohsiung Medical University Hospital from September 2014 to November 2015 . During the operation , we used a robotic grading classification system for verifying the intraoperative accuracy of K-wire placements . Three months after surgery , we used the common CT-base classification system to assess the postoperative accuracy of pedicle screw placements . The distributions of accuracy between the intraoperative robot-assisted and various postoperative CT-based classification systems were compared using kappa statistics of agreement . The intraoperative accuracies of K-wire placements before and after repositioning were classified as excellent ( 131/176 , 74.4 % and 133/176 , 75.6 % , respectively ) , satisfactory ( 36/176 , 20.5 % and 41/176 , 23.3 % , respectively ) , and malpositioned ( 9/176 , 5.1 % and 2/176 , 1.1 % , respectively)In postoperative CT-base classification systems were evaluated . No screw placements were evaluated as unacceptable under any of these systems . Kappa statistics revealed no significant differences between the proposed system and the aforementioned classification systems ( P < 0.001).Our results revealed no significant differences between the intraoperative robotic grading system and various postoperative CT-based grading systems . The robotic grading classification system is a feasible method for evaluating the accuracy of K-wire placements . Using the intraoperative robot grading system to classify the accuracy of K-wire placements enables predicting the postoperative accuracy of pedicle screw placements OBJECT Minimally invasive transforaminal lumbar interbody fusion ( TLIF ) is an increasingly popular procedure . The technique involves use of fluoroscopy to assist with pedicle screw ( PS ) placement . The potential exists for both the surgeon and the patient to become exposed to significant amounts of radiation . The authors undertook this study to quantify the radiation dose to the surgeon and patient during minimally invasive TLIF . METHODS The authors undertook a prospect i ve study of 24 consecutive patients who underwent minimally invasive TLIF . All surgeries were performed by the senior author ( R.K.B. ) , who used techniques previously described . The surgeon wore a radiation monitor under an apron-style lead shield at waist level , at an unshielded collar location , and as a sterile ring badge containing a thermoluminescent dosimeter on the dominant ( right ) h and ring finger . Dosimeter readings were obtained for each case . A total of 33 spinal levels were treated in 24 patients . All treated levels were between L3 - 4 and L5-S1 . In all cases of 1-level disease , 4 PSs were placed , and in all cases of 2-level disease , 6 screws were placed . RESULTS Mean fluoroscopy time was 1.69 minutes per case ( range 3.73 - 0.82 minutes ) . Mean exposure per case to the surgeon on his dominant h and was 76 mRem , at the waist under a lead apron was 27 mRem , and at an unprotected thyroid level was 32 mRem . Mean exposure to the patient 's skin was 59.5 mGy ( range 8.3 - 252 mGy ) in the posteroanterior plane and 78.8 mGy ( range 6.3 - 269.5 mGy ) in the lateral plane . CONCLUSIONS To the authors ' knowledge , this is the first study of radiation exposure to the surgeon or patient in minimally invasive TLIF . Patient exposures were low and compare favorably with exposures involving other common interventional fluoroscopically guided procedures . Surgeon exposures are limited but require careful monitoring . Annual dose limits could be exceeded if a large number of these and other fluoroscopically guided procedures were performed Study Design . A prospect i ve r and omized clinical trial . Objective . To compare the impact of robotic guidance in a minimally invasive spine surgery ( MIS ) to a fluoroscopy-guided open approach in lumbar fusions . Summary of Background Data . MIS requires a protracted learning curve and excessively exposes the patient and surgical team to harmful radiation . Robotic-guidance has been shown to improve accuracy and radiation in most studies , but there is conflicting prospect i ve data . Methods . Patients indicated to undergo a 1 or 2 level spinal fusion were r and omized between robotic-guided MIS ( RO ) and fluoroscopic-guided open surgery ( FA ) . Patient demographics and outcomes were recorded . Results . Thirty patients were recruited to each arm . Average age was 66.7 years , 71.5 % were females , and average body mass index was 25.2 . Thirty-five levels were instrumented with 130 pedicle screws in RO versus 40 levels with 140 screws in FA , or 4.3 and 4.7 screws per surgery , respectively . Use of fluoroscopy was 3.5 versus 13.3 seconds in the RO and FA respectively ( P < 0.001 ) . C-arm output in mSv was 0.13 versus 0.27 in the RO and FA respectively ( P = 0.015 ) . By thermoluminescent dosimeters , the average per-screw radiation in the RO arm was 37.5 % of that in the FA arm , demonstrating a mean reduction of 62.5 % in use of radiation . There was no difference in the improvement in Visual Analog Scale scores for back and leg or the Oswestry Disability Index . All screws were accurate in RO whereas two screws breached ( > 2 mm and > 4 mm ) in FA ( P = 0.500 ) . One proximal facet violation occurred in the study , it was in FA ( P = 1.000 ) . The average distance from the proximal facets was 5.8 versus 4.6 mm in the RO and FA respectively ( P < 0.001 ) . The average length of stay was 6.8 versus 9.4 days in RO compared with FA ( P = 0.020 ) . Conclusion . MIS using robotic-guidance significantly reduced radiation exposure and length of stay . Patient outcomes were not affected by the surgical technique . Level of Evidence : Bone-mounted robotic guidance for pedicle screw placement has been recently introduced , aim ing at increasing accuracy . The aim of this prospect i ve study was to compare this novel approach with the conventional fluoroscopy assisted freeh and technique ( not the two- or three-dimensional fluoroscopy-based navigation ) . Two groups were compared : 11 patients , constituting the robotical group , were instrumented with 64 pedicle screws ; 23 other patients , constituting the fluoroscopic group , were also instrumented with 64 pedicle screws . Screw position was assessed by two independent observers on postoperative CT-scans using the Rampersaud A to D classification . No neurological complications were noted . Grade A ( totally within pedicle margins ) accounted for 79 % of the screws in the robotically assisted and for 83 % of the screws in the fluoroscopic group respectively ( p = 0.8 ) . Grade C and D screws , considered as misplacements , accounted for 4.7 % of all robotically inserted screws and 7.8 % of the fluoroscopically inserted screws ( p = 0.71 ) . The current study did not allow to state that robotically assisted screw placement supersedes the conventional fluoroscopy assisted technique , although the literature is more optimistic about the former Study Design . Single-center prospect i ve r and omized controlled study . Objective . To evaluate the accuracy of robot-assisted ( RO ) implantation of lumbar/sacral pedicle screws in comparison with the freeh and ( FH ) conventional technique . Summary of Background Data . SpineAssist is a miniature robot for the implantation of thoracic , lumbar , and sacral pedicle screws . The system , studied in cadaver and cohort studies , revealed a high accuracy , so far . A direct comparison of the robot assistance with the FH technique is missing . Methods . Patients requiring mono- or bisegmental lumbar or lumbosacral
Output:
| CONCLUSIONS Robotics in spine surgery is an emerging technology that holds promise for future applications .
Surgical accuracy in instrumentation implanted using robotics appears to be high .
However , the impact of robotics on radiation exposure is not clear and seems to be dependent on technique and robot type |
MS213954 | ***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 paper describes the rationale and design of the vanguard for the Comparison of Depression Interventions after Acute Coronary Syndrome ( CODIACS ) , a multicenter , r and omized , controlled trial of a patient preference-based , stepped care protocol for persistent depressive symptoms after acute coronary syndrome ( ACS ) . The overall aim of the vanguard phase was to determine whether the patient-preference , stepped care protocol , which is based on the intervention used in the recent Coronary Psychosocial Evaluation Studies ( COPES ) trial , was feasible in patients with recent ACS who were recruited from 5 geographically diverse sites . Innovative design features of this trial include r and omization to either initial patient-preference of treatment or to a referred care arm in which the primary care provider decided upon care . Additionally , delivery of psychotherapy was accomplished by telephone , or webcam , depending upon patient preference . The vanguard phase provides estimates of eligibility and screening/enrollment ratios , patient acceptance of screening , and retention . In this report , we describe the innovative features and the baseline results of the vanguard phase of CODIACS . The data from this vanguard study will be used to finalize planning for a large , phase III clinical trial design ed to evaluate the effect of treatment on depressive symptoms , coronary events , and death CONTEXT Depression and low perceived social support ( LPSS ) after myocardial infa rct ion ( MI ) are associated with higher morbidity and mortality , but little is known about whether this excess risk can be reduced through treatment . OBJECTIVE To determine whether mortality and recurrent infa rct ion are reduced by treatment of depression and LPSS with cognitive behavior therapy ( CBT ) , supplemented with a selective serotonin reuptake inhibitor ( SSRI ) antidepressant when indicated , in patients enrolled within 28 days after MI . DESIGN , SETTING , AND PATIENTS R and omized clinical trial conducted from October 1996 to April 2001 in 2481 MI patients ( 1084 women , 1397 men ) enrolled from 8 clinical centers . Major or minor depression was diagnosed by modified Diagnostic and Statistical Manual of Mental Disorders , Fourth Edition criteria and severity by the 17-item Hamilton Rating Scale for Depression ( HRSD ) ; LPSS was determined by the Enhancing Recovery in Coronary Heart Disease Patients ( ENRICHD ) Social Support Instrument ( ESSI ) . R and om allocation was to usual medical care or CBT-based psychosocial intervention . INTERVENTION Cognitive behavior therapy was initiated at a median of 17 days after the index MI for a median of 11 individual sessions throughout 6 months , plus group therapy when feasible , with SSRIs for patients scoring higher than 24 on the HRSD or having a less than 50 % reduction in Beck Depression Inventory scores after 5 weeks . MAIN OUTCOME MEASURES Composite primary end point of death or recurrent MI ; secondary outcomes included change in HRSD ( for depression ) or ESSI scores ( for LPSS ) at 6 months . RESULTS Improvement in psychosocial outcomes at 6 months favored treatment : mean ( SD ) change in HRSD score , -10.1 ( 7.8 ) in the depression and psychosocial intervention group vs -8.4 ( 7.7 ) in the depression and usual care group ( P<.001 ) ; mean ( SD ) change in ESSI score , 5.1 ( 5.9 ) in the LPSS and psychosocial intervention group vs 3.4 ( 6.0 ) in the LPSS and usual care group ( P<.001 ) . After an average follow-up of 29 months , there was no significant difference in event-free survival between usual care ( 75.9 % ) and psychosocial intervention ( 75.8 % ) . There were also no differences in survival between the psychosocial intervention and usual care arms in any of the 3 psychosocial risk groups ( depression , LPSS , and depression and LPSS patients ) . CONCLUSIONS The intervention did not increase event-free survival . The intervention improved depression and social isolation , although the relative improvement in the psychosocial intervention group compared with the usual care group was less than expected due to substantial improvement in usual care patients Background Community studies reveal people with coronary heart disease ( CHD ) are twice as likely to be depressed as the general population and that this co-morbidity negatively affects the course and outcome of both conditions . There is evidence for the efficacy of collaborative care and case management for depression treatment , and whilst NICE guidelines recommend these approaches only where depression has not responded to psychological , pharmacological , or combined treatments , these care approaches may be particularly relevant to the needs of people with CHD and depression in the earlier stages of stepped care in primary care setting s. Methods This pilot r and omised controlled trial will evaluate whether a simple intervention involving a personalised care plan , elements of case management and regular telephone review is a feasible and acceptable intervention that leads to better mental and physical health outcomes for these patients . The comparator group will be usual general practitioner ( GP ) care.81 participants have been recruited from CHD registers of 15 South London general practice s. Eligible participants have probable major depression identified by a score of ≥8 on the Hospital Anxiety and Depression Scale depression subscale ( HADS-D ) together with symptomatic CHD identified using the Modified Rose Angina Question naire . Consenting participants are r and omly allocated to usual care or the personalised care intervention which involves a comprehensive assessment of each participant ’s physical and mental health needs which are documented in a care plan , followed by regular telephone review s by the case manager over a 6-month period . At each review , the intervention participant ’s mood , function and identified problems are review ed and the case manager uses evidence based behaviour change techniques to facilitate achievement of goals specified by the patient with the aim of increasing the patient ’s self efficacy to solve their problems . Depressive symptoms measured by HADS score will be collected at baseline and 1 , 6- and 12 months post r and omisation . Other outcomes include CHD symptoms , quality of life , wellbeing and health service utilisation . Discussion This practical and patient-focused intervention is potentially an effective and accessible approach to the health and social care needs of people with depression and CHD in primary care . Trial registration IS RCT N21615909 Background In the presence of type 2 diabetes ( T2DM ) or coronary heart disease ( CHD ) , depression is under diagnosed and under treated despite being associated with worse clinical outcomes . Our earlier pilot study demonstrated that it was feasible , acceptable and affordable for practice nurses to extend their role to include screening for and monitoring of depression alongside biological and lifestyle risk factors . The current study will compare the clinical outcomes of our model of practice nurse-led collaborative care with usual care for patients with depression and T2DM or CHD . Methods This is a cluster-r and omised intervention trial . Eighteen general practice s from regional and metropolitan areas agreed to join this study , and were allocated r and omly to an intervention or control group . We aim to recruit 50 patients with co-morbid depression and diabetes or heart disease from each of these practice s. In the intervention group , practice nurses ( PNs ) will be trained for their enhanced roles in this nurse-led collaborative care study . Patients will be invited to attend a practice nurse consultation every 3 months prior to seeing their usual general practitioner . The PN will assess psychological , physiological and lifestyle parameters then work with the patient to set management goals . The outcome of this assessment will form the basis of a GP Management Plan document . In the control group , the patients will continue to receive their usual care for the first six months of the study before the PNs undergo the training and switch to the intervention protocol . The primary clinical outcome will be a reduction in the depression score . The study will also measure the impact on physiological measures , quality of life and on patient attitude to health care delivered by practice nurses . Conclusion The strength of this programme is that it provides a sustainable model of chronic disease management with monitoring and self-management assistance for physiological , lifestyle and psychological risk factors for high-risk patients with co-morbid depression , diabetes or heart disease . The study will demonstrate whether nurse-led collaborative care achieves better outcomes than usual care BACKGROUND Patients with depression and poorly controlled diabetes , coronary heart disease , or both have an increased risk of adverse outcomes and high health care costs . We conducted a study to determine whether coordinated care management of multiple conditions improves disease control in these patients . METHODS We conducted a single-blind , r and omized , controlled trial in 14 primary care clinics in an integrated health care system in Washington State , involving 214 participants with poorly controlled diabetes , coronary heart disease , or both and coexisting depression . Patients were r and omly assigned to the usual-care group or to the intervention group , in which a medically supervised nurse , working with each patient 's primary care physician , provided guideline -based , collaborative care management , with the goal of controlling risk factors associated with multiple diseases . The primary outcome was based on simultaneous modeling of glycated hemoglobin , low-density lipoprotein ( LDL ) cholesterol , and systolic blood-pressure levels and Symptom Checklist-20 ( SCL-20 ) depression outcomes at 12 months ; this modeling allowed estimation of a single overall treatment effect . RESULTS As compared with controls , patients in the intervention group had greater overall 12-month improvement across glycated hemoglobin levels ( difference , 0.58 % ) , LDL cholesterol levels ( difference , 6.9 mg per deciliter [ 0.2 mmol per liter ] ) , systolic blood pressure ( difference , 5.1 mm Hg ) , and SCL-20 depression scores ( difference , 0.40 points ) ( P<0.001 ) . Patients in the intervention group also were more likely to have one or more adjustments of insulin ( P=0.006 ) , antihypertensive medications ( P<0.001 ) , and antidepressant medications ( P<0.001 ) , and they had better quality of life ( P<0.001 ) and greater satisfaction with care for diabetes , coronary heart disease , or both ( P<0.001 ) and with care for depression ( P<0.001 ) . CONCLUSIONS As compared with usual care , an intervention involving nurses who provided guideline -based , patient-centered management of depression and chronic disease significantly improved control of medical disease and depression . ( Funded by the National Institute of Mental Health ; Clinical Trials.gov number , NCT00468676 . ) Objectives To determine the effectiveness of collaborative care in reducing depression in primary care patients with diabetes or heart disease using practice nurses as case managers . Design A two-arm open r and omised cluster trial with wait-list control for 6 months . The intervention was followed over 12 months . Setting Eleven Australian general practice s , five r and omly allocated to the intervention and six to the control . Participants 400 primary care patients ( 206 intervention , 194 control ) with depression and type 2 diabetes , coronary heart disease or both . Intervention The practice nurse acted as a case manager identifying depression , review ing pathology results , lifestyle risk factors and patient goals and priorities . Usual care continued in the controls . Main outcome measure A five-point reduction in depression scores for patients with moderate-to-severe depression . Secondary outcome was improvements in physiological measures . Results Mean depression scores after 6 months of intervention for patients with moderate-to-severe depression decreased by 5.7±1.3 compared with 4.3±1.2 in control , a significant ( p=0.012 ) difference . ( The plus – minus is the 95 % confidence range . ) Intervention practice s demonstrated adherence to treatment guidelines and intensification of treatment for depression , where exercise increased by 19 % , referrals to exercise programmes by 16 % , referrals to mental health workers ( MHWs ) by 7 % and visits to MHWs by 17 % . Control- practice exercise did not change , whereas referrals to exercise programmes dropped by 5 % and visits to MHWs by 3 % . Only referrals to MHW increased by 12 % . Intervention improvements were sustained over 12 months , with a significant ( p=0.015 ) decrease in 10-year cardiovascular disease risk from 27.4±3.4 % to 24.8±3.8 % . A review of patients indicated that the study 's safety protocol s were followed . Conclusions TrueBlue participants showed significantly improved depression and treatment intensification , sustained over 12 months of intervention and reduced 10-year cardiovascular disease risk . Collaborative care using practice nurses appears to be an effective primary care intervention . Trial registration ACTRN12609000333213 ( Australia and New Zeal and Clinical Trials Registry ) Objective : To present the design of the Bypassing the Blues ( BtB ) study to examine the impact of a collaborative care strategy for treating depression among patients with cardiac disease . Coronary artery bypass graft ( CABG ) surgery is one of the most common and costly medical procedures performed in the US . Up to half of post-CABG patients report depressive symptoms , and they are more likely to experience poorer health-related quality of life ( HRQoL ) , worse functional status , continued chest pains , and higher risk of cardiovascular morbidity independent of cardiac status , medical comorbidity , and the extent of bypass surgery . Methods : BtB was design ed to enroll 450 post-CABG patients from eight Pittsburgh-area hospitals including : ( 1 ) 300 patients who expressed mood symptoms preceding discharge and at 2 weeks post hospitalization ( Patient Health Question naire ( PHQ-9 ) ≥10 ) ; and ( 2 ) 150 patients who served as
Output:
| CONCLUSIONS Collaborative depression care did not lead to a sustained reduction in the primary MACE end point .
Small effects were observed for depression , depression remission , anxiety and mental QOL . |
MS213955 | ***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: From a review of thirty published papers it is clear that the variety of options for treatment of hepatitis B have led to a large number of small exploratory trials . However , small groups lead to imprecise estimates of seroconversion rates ; for example a result of 4/10 gives an estimate of 40 % with 80 % confidence limits of 20 % and 60 % . A number of possible prognostic factors have been proposed and , whilst their importance is generally unproven , their estimated effects are considerable . Comparison between studies can therefore be misleading ; for example comparing two treatments A and B of identical efficacy in two common population s could give a 1 in 4 chance of declaring B to give double the seroconversion rate of A. Larger , r and omised , controlled trials on homogeneous patient groups are needed to give conclusive evidence of the efficacy or otherwise of various treatment regimes R and omized clinical trials ( RCTs ) provide the most reliable therapeutic information available . Unfortunately , there are no systemic listing of RCTs . We compared a MEDLARS search of 3686 biomedical journals for RCTs with a manual search of the medical literature for the period 1966 - 1982 . For the former search we used subject headings ( 1 ) liver disease or ( 2 ) biliary tract disease and subheadings ( 1 ) drug therapy , ( 2 ) surgery , ( 3 ) radiotherapy , or ( 4 ) therapy , and check tags ( 1 ) comparative study or ( 2 ) clinical research . For the manual search , the contents of 34 arbitrarily selected , gastroenterologic , hepatologic , surgical , or general journals were perused . The MEDLARS search identified 160 RCTs and 29 others were found in the references of the 160 . One hundred fifty-four RCTs were identified by both methods . The manual search identified 208 RCTs and an additional 34 were found in the references of the 208 . The MEDLARS search identified only 107 of 208 RCTs found in the references of the 208 . The MEDLARS search identified only 107 of 208 RCTs found manually in the 36 journals , an efficiency rate of 51 % . We estimate that 330 hepatobiliary RCTs had been published during this 17-year period . Sixty percent of the RCTs found by MEDLARS used the key word " r and omized , " " double blind , " or " controlled " in the title , compared to 36 % in those found by the manual search . In order to retrieve RCTs , it is essential that editors require that RCTs be identified in their titles or key words by specific terms such as " controlled , " " r and omized , " and " double blind , " that papers be so catalogued and indexed , and that search ers be instructed in appropriate search strategies In a double-blind study human leucocyte interferon was given for six weeks to 8 of 16 patients with chronic HBsAg-positive hepatitis . In the first week 12 x 10(6 ) reference units were administered daily , and thereafter the dose was halved every week . During the first two weeks leucopenia was observed in 6 of the 8 interferon-treated patients . Apart from a drop in DNA-polymerase activity in the first week , no effect was found on indices of hepatitis-B-virus infection THE R AND OMIZED controlled trial ( RCT ) , more than any other methodology , can have a powerful and immediate impact on patient care . Ideally , the report of such an evaluation needs to convey to the reader relevant information concerning the design , conduct , analysis , and generalizability of the trial . This information should provide the reader with the ability to make informed judgments regarding the internal and external validity of the trial . Accurate and complete reporting also benefits editors and review ers in their deliberations regarding su bmi tted manuscripts . For RCTs to ultimately benefit patients , the published report should be of the highest possible st and ard A grid devised to evaluate the method ological quality of r and omized therapeutic trials is presented . Fourteen items are analysed : description of the principal criterion of assessment , criteria of inclusion , number of subjects seen and excluded , number of subjects r and omized to each group , number of subjects excluded who are alive or lost to follow-up and reasons for the fall-outs , blind character of the doctors , patients and persons responsible for the assessment criteria , calculation of the number of subjects required before starting the trial , method of r and omization and its blind character , analysis and discussion of covariables , statistical tests used , taking into account of the fall-outs and power of the trials with non-significant results . This grid , used for the analysis of 527 r and omized trials , showed that about one-half of them were of mediocre quality , the most frequent defects encountered being the multiplicity of assessment criteria , the lack of description of the subjects excluded , the absence of calculation of the number of subjects required before starting the trial and the small number of subjects in trials with non-significant results 46 male chronic hepatitis B virus ( HBV ) carriers with active viral replication were r and omised , with stratification for histology and sexual preference , to receive six months ' lymphoblastoid interferon or no therapy . After nine to eighteen months ' follow-up , HBeAg was no longer detectable and anti-HBe was present in 6 of the 23 treated patients . HBsAg was not detectable in 5 of these patients and 3 had anti-HBs . All of the controls remained positive for HBeAg and HBsAg . Seroconversion from HBeAg to anti-HBe was preceded in all cases by a pronounced increase in serum aspartate aminotransferase levels of more than ten times the upper limit of normal at eight to twelve weeks ; this response was exclusively associated with interferon therapy . These results suggest that loss of HBsAg and a hepatitis-like illness in the third month of therapy are direct effects of interferon treatment BACKGROUND & AIMS Long-term ursodeoxycholic acid ( UDCA ) therapy slows the progression of primary biliary cirrhosis . This study examined the effect of UDCA therapy on survival free of liver transplantation in a large group of patients . METHODS Data from three clinical trials were combined in which patients with primary biliary cirrhosis were r and omly assigned to receive UDCA ( n = 273 ) or placebo ( n = 275 ) . After 2 years , patients from French and Canadian studies received UDCA for up to 2 years . Patients from the American study remained on their assigned treatment for up to 4 years . RESULTS Survival free of liver transplantation was significantly improved in the patients treated with UDCA compared with the patients originally assigned to placebo ( P < 0.001 ; relative risk , 1.9 ; 95 % confidence interval , 1.3 - 2.8 ) . Subgroup analyses showed that survival free of liver transplantation was significantly improved in medium- and high-risk groups ( serum bilirubin level , 1.4 to 3.5 or > 3.5 mg/dL ; P < 0.0001 and P < 0.03 , respectively ) and histological stage IV subgroup ( P < 0.01 ) . CONCLUSIONS Long-term UDCA therapy improves survival free of liver transplantation in patients with moderate or severe disease . An effect in patients with mild disease is probably not found because they do not progress to end-stage disease in 4 years Forty-five patients with chronic hepatitis B were entered into a r and omized controlled trial of recombinant human alpha-interferon therapy . All patients had hepatitis B surface antigen in serum for at least 1 yr and had stable serum levels of both hepatitis B virus deoxyribonucleic acid and hepatitis B e antigen . During the 4-mo period of therapy , 10 of 31 ( 32 % ) treated patients and only 1 of 14 ( 7 % ) control patients became negative for serum hepatitis B virus deoxyribonucleic acid and deoxyribonucleic acid polymerase . All 10 patients who became negative for serum hepatitis B virus deoxyribonucleic acid subsequently had a marked improvement in serum aminotransferase activities and lost hepatitis B e antigen from serum , and 9 of them had improvement in liver histology . Comparison of responders to nonresponders indicated that female sex and a high initial level of serum aspartate aminotransferase correlated best with response to interferon therapy . These findings indicate that a 4-mo course of recombinant alpha-interferon can induce a remission in disease in approximately one-third of patients with chronic hepatitis
Output:
| The second hypothesis was that survival of truth should be higher for negative conclusions than for positive conclusions .
A negative conclusion has a better chance of survival because the only way it would not continue to be negative is if it were found to be false .
A positive conclusion risks being found to be false or becoming obsolete .
Conclusions from older research are at greater risk for being refuted or becoming obsolete than are conclusions from more recent studies . |
MS213956 | ***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 effect of 8 wk of progressive bicycle training on the immune system was evaluated in a controlled study on 18 patients with rheumatoid arthritis and moderate disease activity . Maximal O2 uptake increased significantly , whereas heart rate at stage 2 and rate of perceived exertion decreased significantly , in the training group compared with the controls . Resting levels of a number of immune parameters were measured before and after 4 and 8 wk of training . Training did not induce changes in blood mononuclear cell sub population s , proliferative response , or natural killer cell activity . Furthermore the plasma concentrations of interleukin-1 alpha , interleukin-1 beta , and interleukin-6 did not change in response to training . It is concluded that 8 wk of bicycle training does not influence the immune system of patients with rheumatoid arthritis OBJECTIVE To investigate physical fitness and work capacity in women with rheumatoid arthritis ( RA ) . METHODS The 42 subjects were a subset of a prospect i ve trial of conditioning exercise in rheumatic disease . Assignment to an exercise or nonexercise group was determined by proximity to the intervention , a 3-month supervised group exercise program . Physical fitness and work capacity were assessed at baseline , 3 months , and 12 months . RESULTS At baseline , subjects were deconditioned and limited in h and function , lifting ability , and lower extremity mobility . Only the exercise group improved their aerobic capacity and exercise tolerance . There were no significant changes in measured work capacity in either group . Moderate to strong correlations were found between aerobic capacity , mobility , h and function , and work capacity . Grip strength was a strong and consistent correlate of work capacity . CONCLUSION Our findings suggest that physical capacity , particularly h and function , may be important in the complex phenomenon of work disability in RA The objective was to study the long-term effect ( 2 years ) of different training programs in patients with rheumatoid arthritis . The method was a r and omized trial with 75 patients participating . The measured variables included morning stiffness , a pain score , number of swollen joints , a health assessment score , a functional score , ESR , Hb , the cost of medicine , and progression using X-rays of h and s and feet . The results showed no effect of training on the disease activity or on the progression of the disease . The conclusion is that although most patients are in favour of training , the present study does not support that training lessons per se affect the disease activity or the progression of the disease Twenty-six patients with rheumatoid arthritis ( RA ) participated either in a 21 day , community sponsored , in-patient multidisciplinary rehabilitation program ( N = 20 ) or ; received traditional , out-patient physiotherapy design ed by the patient 's rheumatologist ( N = 6 ) . Clinical assessment s were made ( prior to , immediately after , and 6 months after rehabilitation ) to evaluate the response to these two quite different rehabilitative measures that included : functional classification , joint score index , subjective VAS of pain , HAQ , pain disability index , Comprehensible psychopathological rating scale , hemoglobin , and CRP measurements . Economic assessment s included salary , direct and community sponsored costs , for rehabilitation and costs for sick days and production losses . No clear-cut differences between the two rehabilitation modes were detected . Both modes showed improvement in different assessment parameters ; patients with higher education and , therefore , with a less joint-disturbing work profile appeared to profit more from an extensive in-patient rehabilitation program . Patients with less education and a more manually-oriented working profile , did worse and had a higher tendency to seek medical pensioning , in spite of rehabilitative measures . As the total costs for out-patient rehabilitation only add up to 15.8 % of the total costs for in-patient rehabilitation , this study setting cautiously suggests that out-patient rehabilitation might be an acceptable alternative to individualized patient groups that might not compromise clinical and vocational outcome . Larger patient groups are needed , however , to confirm these findings The aim of the study was to evaluate the effects of a dynamic training program versus a muscle relaxation training program as home exercise in patients with inflammatory rheumatic diseases . Fifty-four patients ( mean age 54 years , mean symptom duration 14 years ) were r and omized to one of the two programs . After personal instructions every patient exercised at home for half an hour , 5 days a week during 3 months . Before and after the interventions , all patients were assessed for health-related quality of life , joint tenderness and physical capacities . The dynamic training group had improved in perceived exertion at the walking test ( p < or = 0.05 ) , while the relaxation training group had improved their total Nottingham Health Profile ( p < or = 0.01 ) , its subscale for lack of energy ( p < or = 0.05 ) , Ritchie 's articular index ( p < or = 0.05 ) , muscle function of the lower extremities ( p < or = 0.01 ) , and arm endurance ( p < or = 0.01 ) . Regarding changes in muscle function of the lower extremities during the intervention period , there was a significant difference ( p < or = 0.05 ) between the groups in favour of the relaxation training group . The results of the study thus indicated that progressive muscle relaxation training might improve health related quality of life , reduce joint tenderness and be superior to dynamic muscle training in improving the muscle function of the lower extremities in patients with inflammatory rheumatic diseases . The clinical effects were small and the results have to be interpreted with caution Thirty-nine consecutive patients with recent-onset rheumatoid or psoriatic arthritis were r and omly allotted for six months period either to the experimental progressive dynamic strength training group ( EG , 10 women and 11 men ; 41 + /- 10 yrs ) , or to the control group ( CG , 10 women and 8 men ; 45 + /- 11 yrs ) who just maintained their habitual physical activities . All patients received antirheumatic medication throughout the experimental period . During the study period significant improvements took place in the EG in maximal muscle strength of all examined muscle groups ( 31.5 % for the knee extensors , p < 0.001 ; 14.8 % and 10.7 % for the trunk flexors and extensors , p < 0.01 ; 27.8 % and 20.4 % for grip strength , p < 0.001 ) as well as in erytrocyte sedimentation rate ( p < 0.05 ) . Ritchie 's articular index ( RI ) ( p < 0.001 ) and HAQ ( p < 0.01 ) . In the CG only the decrease in RI was statistically significant ( p < 0.05 ) . Erosive changes in joints increased only slightly and less in the EG than in the CG . The present results suggest that dynamic strength training in early arthritis increases the neuromuscular performance without detrimental effects on disease activity or joint damage The effectiveness of an exercise prescription and unsupervised home exercise programme was tested on 37 subjects with rheumatoid arthritis and 34 with systemic lupus erythematosus . Subjects were r and omly assigned to control or stationary bicycling at home , using loaned bicycles . Exercise subjects ( with bicycles ) did better than controls , but not significantly , on all outcome d measures ( exercise tolerance test , fatigue , depression and helplessness ) at 3 months . Bicycles were recl aim ed at 3 months and all subjects in both groups given instructions for home exercise . Exercise in the second 3 months was predicted primarily by baseline exercise habits and fatigue . It is concluded that although safe , unsupervised home exercise programmes may benefit few patients . Future research should address methods of stimulating and maintaining unsupervised exercise programmes in patients with systemic rheumatic disease OBJECTIVE The aim of this study was to evaluate the therapeutic effects of hydrotherapy which combines elements of warm water immersion and exercise . It was predicted that hydrotherapy would result in a greater therapeutic benefit than either of these components separately . METHODS One hundred thirty-nine patients with chronic rheumatoid arthritis were r and omly assigned to hydrotherapy , seated immersion , l and exercise , or progressive relaxation . Patients attended 30-minute sessions twice weekly for 4 weeks . Physical and psychological measures were completed before and after intervention , and at a 3-month followup . RESULTS All patients improved physically and emotionally , as assessed by the Arthritis Impact Measurement Scales 2 question naire . Belief that pain was controlled by chance happenings decreased , signifying improvement . In addition , hydrotherapy patients showed significantly greater improvement in joint tenderness and in knee range of movement ( women only ) . At followup , hydrotherapy patients maintained the improvement in emotional and psychological state . CONCLUSIONS Although all patients experienced some benefit , hydrotherapy produced the greatest improvements . This study , therefore , provides some justification for the continued use of hydrotherapy OBJECTIVE To determine whether hydrotherapy in a thermomineral institution is superior to the same hydrotherapy in an ordinary hospital exercise-bath . DESIGN Controlled therapeutic trial . SETTING The thermomineral institution at Arcen and the exercise bath at the Maasl and Hospital in Sittard , the Netherl and s. PATIENTS AND METHODS 46 patients with rheumatoid arthritis were treated in a by a skilled physiotherapist , according to a st and ardized exercise-scheme : 27 were treated in the thermomineral institution and 19 ( control-group ) in the hospital exercise-bath . Each patient received 12 treatments in 12 weeks . ENDPOINTS PARAMETERS : Morning stiffness , erythrocyte sedimentation rate , Ritchie index , amount of pain , answers to 11 questions concerning the activities of daily life , and psychosocial aspects of the disease . The various subjective and objective parameters were scored by the same physician . RESULTS Statistically significant improvement was observed in both groups concerning morning stiffness . Other subjective parameters improved , but did not reach significance . Objective parameters did not change significantly . Between-group differences were not found . CONCLUSION Hydrotherapy has a positive effect on some subjective but not on objective parameters in patients with rheumatoid arthritis , whether it is applied in a thermomineral institution or an ordinary hospital exercise bath The importance of pain in the health status and health behavior of patients with chronic rheumatic disease was evaluated . The Arthritis Impact Measurement Scales were used to estimate physical disability , psychological status , and pain in a large set of rheumatic disease patients . Explanatory regression models were built to explore the contribution of pain in physician and patient assessment s of overall health , medication usage , and changes in health status over time . Results confirm that pain makes a highly significant contribution to explaining both physician and patient overall health assessment s ( P less than 0.001 ) . Pain is also the most important of the 3 health status components in explaining medication usage ( P less than 0.001 ) . Finally , using prospect i ve data , it is shown that current pain , rather than current physical or psychological disability , is the best predictor of subsequent pain ( P less than 0.001 ) . Current pain also is most associated with subsequent physical disability ( P less than 0.05 ) . These findings confirm the importance of pain in determining the health status and health behavior of individuals with chronic rheumatic disease , and suggest that doctors and other health professionals should continue to solicit and address the patient 's complaints of pain This study aim ed at evaluating the effects of a dynamic physical training programme on circulating levels of corticotropin-releasing hormone ( CRH ) , beta-lipotropin ( beta-LPH ) , and beta-endorphin ( beta-EP ) after high-intensity training for 6 weeks ( 60 min twice a week ) and after low-intensity training ( home-training ) for another 6 months in patients with rheumatoid arthritis ( RA ) and in healthy subjects . Additionally , differences in neuropeptide levels between the two groups were studied . A total of 30 patients with RA were r and omly allocated to the study , 15 in the training group ( TG ) and 15 in the control group ( CG ) . In addition , 20 healthy subjects ( 10 in TG ; 10 in CG ) participated . In addition to the biochemical analyses , the following variables were assessed for the RA group : pain and disability ( Stanford health assessment question naire ) , joint tenderness ( Ritchie articular index ) , disease activity , muscle function , aerobic capacity , sociodemographic data and attitudes . The results obtained at the start revealed significant differences ( p < 0.05 ) between RA patients and healthy subjects concerning CRH levels , RA patients showing the lower levels ( RA-group Md = 24 pmol/L , healthy group Md = 29 pmol/L ) . No significant differences concerning beta-LPH and beta-EP were found here . After the high-intensity training period , a significant increase of the CRH levels were found for the RA-TG ( pretest Md = 24 pmol/L , after 6 weeks Md = 27 pmol/L , p < 0.05 ) . No such results were found for the healthy-TG or the control groups . Concerning beta-EP , significant differences between the RA-TG and healthy-TG were found after the training . RA patients generally showing higher levels as compared with the healthy ( RA-group Md = 42 pmol/L , healthy group Md = 36 pmol/L , p < 0.05 ) . The same pattern was found for the beta-LPH levels . In conclusion , the effects of physical training on circulating neuropeptides remain still incompletely examined , and there is no definite answer to the question whether increased beta-EP levels are good or bad A group of 120 patients with rheumatoid arthritis or osteoarthritis volunteered to be subjects for this study of aerobic versus nonaerobic exercise . Patients were strat
Output:
| The results suggest that dynamic exercise therapy is effective in increasing aerobic capacity and muscle strength .
No detrimental effects on disease activity and pain were observed .
The effects of dynamic exercise therapy on functional ability and radiological progression are unclear .
It is concluded that dynamic exercise therapy has a positive effect on physical capacity . |
MS213957 | ***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 compare the effectiveness of annual topical application of silver diamine fluoride ( SDF ) solution , semi-annual topical application of SDF solution , and annual application of a flowable high fluoride-releasing glass ionomer in arresting active dentine caries in primary teeth . METHODS A total of 212 children , aged 3 - 4 years , were r and omly allocated to one of three groups for treatment of carious dentine cavities in their primary teeth : Gp1-annual application of SDF , Gp2-semi-annual application of SDF , and Gp3-annual application of glass ionomer . Follow-up examinations were carried out every six months to assess whether the treated caries lesions had become arrested . RESULTS After 24 months , 181 ( 85 % ) children remained in the study . The caries arrest rates were 79 % , 91 % and 82 % for Gp1 , Gp2 and Gp3 , respectively ( p=0.007 ) . In the logistic regression model using GEE to adjust for clustering effect , higher caries arrest rates were found in lesions treated in Gp2 ( OR=2.98 , p=0.007 ) , those in anterior teeth ( OR=5.55 , p<0.001 ) , and those in buccal/lingual smooth surfaces ( OR=15.6 , p=0.004 ) . CONCLUSION Annual application of either SDF solution or high fluoride-releasing glass ionomer can arrest active dentine caries . Increasing the frequency of application to every 6 months can increase the caries arrest rate of SDF application . CLINICAL SIGNIFICANCE Arrest of active dentine caries in primary teeth by topical application of SDF solution can be enhanced by increasing the frequency of application from annually to every 6 months , whereas annual paint-on of a flowable glass ionomer can also arrest active dentine caries and may provide a more aesthetic outcome OBJECTIVE To explore whether dentists ' beliefs and attitudes to providing preventive and restorative dental care for young children can form a barrier to the provision of care . BASIC RESEARCH DESIGN The Barriers to Childhood Caries Treatment ( BaCCT ) Question naire , a st and ardised international measure was developed and applied . PARTICIPANTS Through a research consortium , each site was asked to recruit 100 dentists . The sample participating was not intended to be nationally representative . Dentists were mainly r and omly selected and contacted by mail with one or more mailings depending on site . RESULTS 2,333 dentists in 14 countries and 17 sites participated . Factor analysis identified four factors as potential barriers . Two factors were found to be barriers in many sites . First , in most countries , dentists agreed that young children 's coping skills limit their ability to accept dental care . Secondly , dentists with negative personal feelings , for example , that providing care can be stressful and troublesome and that they feel time constrained . Differences in dentists ' beliefs can be partly explained by their work profile , with those treating children often , and those working under systems where they feel they can provide quality care being least likely to identify barriers to providing care for children . CONCLUSIONS The BaCCT Question naire was determined to be a valid psychometric measure . Separately , it was found that health systems do impact on dentists ' ability to deliver preventive and restorative care for children but that these effects vary across countries and further work is needed to determine how best these should be examined Since there is no consensus on the anticaries effectiveness of low-fluoride ( F ) dentifrice , this r and omized clinical trial evaluated its effect in children at different caries activity status . One hundred and twenty 2- to 4-year-old children , half with and half without active caries lesions , were r and omly divided into 2 groups which used 500- or 1,100-µg F/g ( NaF ) dentifrices during 1 year . Caries progression or regression were evaluated as the number of lesions becoming active/cavities or inactive , respectively . The anticaries effect of the low-F dentifrice was similar to the conventional F dentifrice when used by caries-inactive children . However , in children with active caries lesions the low-F dentifrice was less effective than the 1,100-µg F/g dentifrice in controlling the progression of lesions . The data suggest that the child caries activity may be taken into account to recommend a low-F dentifrice Background Dental caries is a major public health problem in many countries . Since the last territority-wide dental survey of Hong Kong preschool children was conducted in 2001 , a survey to up date the information is necessary . This study aim ed to describe the dental caries experience of preschool children in Hong Kong and factors affecting their dental caries status . Methods A stratified r and om sample of children from seven kindergartens in Hong Kong was surveyed in 2009 . Ethical approval from IRB and parental consent was obtained . Clinical examinations of the children were performed by two calibrated examiners using disposable dental mirrors , an intra-oral LED light and ball-ended periodontal probes . A question naire to investigate possible explanatory factors for caries status was completed by the children ’s parents . Caries experience was recorded using the dmft index . Multifactor-ANOVA was used to study the relationship between dental caries experience , and the background and oral health-related behaviours of the children . Results Seven hundred children ( 53 % boys ) , mean age 5.3 ± 0.7 years were examined . The mean dmft score of the surveyed children was 2.2 and 51 % of them had no caries experience ( dmft = 0 ) . Most ( > 95 % ) of the decayed teeth were untreated . Statistically significant correlations were found between dental caries experience of the children and their oral health-related habits , family income , parental education level and parental dental knowledge . Conclusions Early childhood dental caries was prevalent among the preschool children in Hong Kong . Their caries experience was associated with their oral health-related behaviours , socio-economic background , and parental education and dental knowledge 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 To evaluate the effectiveness of a xylitol pediatric topical oral syrup to reduce the incidence of dental caries among very young children and to evaluate the effect of xylitol in reducing acute otitis media in a subsequent study . DESIGN Double-blind r and omized controlled trial . SETTING Communities in the Republic of the Marshall Isl and s. PARTICIPANTS One hundred eight children aged 9 to 15 months were screened , and 100 were enrolled . Intervention Children were r and omized to receive xylitol topical oral syrup ( administered by their parents ) twice a day ( 2 xylitol [ 4.00-g ] doses and 1 sorbitol dose ) ( Xyl-2 x group ) or thrice per day ( 3 xylitol [ 2.67-g ] doses ) ( Xyl-3x group ) vs a control syrup ( 1 xylitol [ 2.67-g ] dose and 2 sorbitol doses ) ( control group ) . MAIN OUTCOME MEASURES The primary outcome end point of the study was the number of decayed primary teeth . A secondary outcome end point was the incidence of acute otitis media for reporting in a subsequent report . RESULTS Ninety-four children ( mean [ SD ] age , 15.0 [ 2.7 ] months at r and omization ) with at least 1 follow-up examination were included in the intent-to-treat analysis . The mean ( SD ) follow-up period was 10.5 ( 2.2 ) months . Fifteen of 29 of the children in the control group ( 51.7 % ) had tooth decay compared with 13 of 32 children in the Xyl-3x group ( 40.6 % ) and eight of 33 children in the Xyl-2x group ( 24.2 % ) . The mean ( SD ) numbers of decayed teeth were 1.9 ( 2.4 ) in the control group , 1.0 ( 1.4 ) in the Xyl-3x group , and 0.6 ( 1.1 ) in the Xyl-2x group . Compared with the control group , there were significantly fewer decayed teeth in the Xyl-2x group ( relative risk , 0.30 ; 95 % confidence interval , 0.13 - 0.66 ; P = .003 ) and in the Xyl-3x group ( 0.50 ; 0.26 - 0.96 ; P = .04 ) . No statistical difference was noted between the 2 xylitol treatment groups ( P = .22 ) . CONCLUSION Xylitol oral syrup administered topically 2 or 3 times daily at a total daily dose of 8 g was effective in preventing early childhood caries The recording of multiple interval-censored failure times is common in dental research . Modeling multilevel data has been a difficult task . This paper aims to use the Bayesian approach to analyze a set of multilevel clustered interval-censored data from a clinical study to investigate the effectiveness of silver diamine fluoride and sodium fluoride varnish in arresting active dentin caries in Chinese pre-school children . The time to arrest dentin caries on a surface was measured . A three-level r and om-effects Weibull regression model was used . Analysis was performed with WinBUGS . Results revealed a strong positive correlation ( 0.596 ) among the caries lesions ’ arrest times on different surfaces from the same child . The software WinBUGS made the above complicated estimation simple . In conclusion , the annual application of silver diamine fluoride on caries lesions , and caries removal before the application , were found to shorten the arrest time To investigate the effectiveness of topical fluorides in preventing fissure caries , we conducted a r and omized controlled trial with parallel groups . In total , 501 children ( 1,539 molars , 3,078 sites ) , mean age 9.1 years , who had at least one sound permanent first molar with deep fissures or fissures with signs of early caries were recruited . They were r and omly allocated among four groups : ( 1 ) resin sealant , single placement ; ( 2 ) 5 % NaF varnish , semi-annual application ; ( 3 ) 38 % silver diamine fluoride ( SDF ) solution , annual application ; and ( 4 ) placebo control . Follow-up examinations were conducted every 6 months by a masked examiner . After 24 months , 485 children ( 97 % ) were examined . Proportions of pit/fissure sites with dentin caries in the sealant , NaF , SDF , and control groups were 1.6 % , 2.4 % , 2.2 % , and 4.6 % , respectively . A multi-level logistic regression analysis accounting for the effects of data clustering and confounding factors showed that fissures in any of the three treatment groups had significantly lower risks of carious cavity development into dentin than did controls ( p < 0.05 ) . We concluded that placement of resin sealant , semi-annual application of NaF varnish , and annual application of SDF solution are all effective in preventing pit and fissure caries in permanent molars ( Clinical Trials.gov number CT01446107 ) Background There is growing interest in the use of diammine silver fluoride ( DSF ) as a topical agent to treat dentin hypersensitivity and dental caries as gauged by increasing published research from many parts of the world . While DSF has been available in various formulations for many years , most of its pharmacokinetic aspects within the therapeutic concentration range have never been fully characterized . Methods This preliminary study determined the applied doses ( 3 teeth treated ) , maximum serum concentrations , and time to maximum serum concentration for fluoride and silver in 6 adults over 4 h. Fluoride was determined using the indirect diffusion method with a fluoride selective electrode , and silver was determined using inductively coupled plasma-mass spectrometry . The mean amount of DSF solution applied to the 3 teeth was 7.57 mg ( 6.04 μL ) . Results Over the 4 hour observation period , the mean maximum serum concentrations were 1.86 μmol/L for fluoride and 206 nmol/L for silver . These maximums were reached 3.0 h and 2.5 h for fluoride and silver , respectively . Conclusions Fluoride exposure was below the U.S. Environmental Protection Agency ( EPA ) oral reference dose . Silver exposure exceeded the EPA oral reference dose for cumulative daily exposure over a lifetime , but for occasional use was well below concentrations associated with toxicity . This preliminary study suggests that serum concentrations of fluoride and silver after topical application of DSF should pose little toxicity risk when used in adults . Clinical trials registration NCT01664871 This study compared the ability of two sodium fluoride dentifrices , one containing 5,000 ppm fluoride ( Prevident 5000 Plus ) and the other 1,100 ppm fluoride ( Winterfresh Gel ) , to reverse primary root caries lesions ( PRCLs ) . A total of 201 subjects with at least one PRCL each entered the study and were r and omly allocated to use one of the dentifrices . After 6 months , 186 subjects were included in statistical analyses . At baseline and after 3 and 6 months , the lesions were clinical ly assessed and their electrical resistance measured using an electrical caries monitor . After 3 months , 39 ( 38.2 % ) of the 102 subjects in the 5,000 ppm F– group and 9 ( 10.7 %
Output:
| Conclusions There is limited evidence to support the effectiveness of SDF applications or daily toothbrushing with fluoride toothpaste in arresting or slowing down the progression of active dentin caries in primary teeth in preschool children . |
MS213958 | ***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 carried out a prospect i ve , r and omised controlled trial on two groups of 40 patients with painful calcific tendonitis and a mean age of 48.4 years ( 32.5 to 67.3 ) . All were to undergo arthroscopic removal of the calcific deposit within six months after r and omisation . The 40 patients in group I received ultrasound-guided needling followed by high-energy shock-wave therapy and the 40 in group II had shock-wave therapy alone . In both groups one treatment consisting of 2500 impulses of shock waves with an energy flux density of 0.36 mJ/mm(2 ) was applied . The clinical and radiological outcome was assessed using the 100-point Constant shoulder scoring system and st and ardised radiographs . The mean follow-up was 4.1 months and no patient was lost to follow-up . Both groups had significant improvement in their Constant shoulder score . Radiographs showed disappearance of the calcific deposit in 60.0 % of the shoulders in group I and in 32.5 % of group II ( p < 0.05 ) . Significantly better clinical and radiological results were obtained in group I than in group II . Arthroscopic removal of the deposit was avoided in 32 patients of group I and in 22 of group II . No severe side-effects were recorded . Ultrasound-guided needling in combination with high-energy shock-wave therapy is more effective than shock-wave therapy alone in patients with symptomatic calcific tendonitis , giving significantly higher rates of elimination of the calcium deposits , better clinical results and reduction in the need for surgery PURPOSE To evaluate clinical response to treatment of calcified tendinitis of the shoulder by using a modified percutaneous ultrasonography (US)-guided fine-needle technique . MATERIAL S AND METHODS Thirty shoulders of 30 consecutive patients ( 23 women , seven men ; mean age , 47.4 years ) with chronic shoulder pain ( average duration , 43.1 months ) refractory to medical treatment were treated percutaneously by using a fine needle and US guidance . Patients were prospect ively evaluated by using a shoulder pain and disability index consisting of 13 items and divided into two subcategories : pain and disability . The patient completed the question naire before the procedure and during the follow-up visit approximately 1 month later . A diagnostic US examination was also performed at that time . RESULTS There was a statistically significant improvement in the shoulder pain and disability index total score ( 27.0 % ) and the pain ( 30.5 % ) and disability ( 23.9 % ) scores . According to the index , these results indicate a significant clinical response . CONCLUSION This modified US-guided fine-needle technique for calcified tendinitis of the shoulder appears to be an effective therapy and was less aggressive than previously described percutaneous techniques PURPOSE To compare short- and long-term outcomes of patients with rotator cuff calcific tendonitis who did and did not undergo ultrasonographically (US)-guided percutaneous treatment . MATERIAL S AND METHODS Institutional review board approval and informed patient consent were obtained . Of patients referred for US-guided treatment of rotator cuff calcific tendonitis , 219 ( 86 men , 133 women ; mean age , 40.3 years + /- 10.9 [ st and ard deviation ] ) were treated ; 68 ( 31 men , 37 women ; mean age , 40.2 years + /- 11.3 ) patients refused treatment and served as control subjects . After local anesthesia was induced , two 16-gauge needles were inserted into the calcific deposit . Saline solution was injected through one needle , and the dissolved calcium was extracted through the other needle . Shoulder joint function was assessed by using Constant scores , and pain was assessed by using visual analogue scale ( VAS ) scores . Mann-Whitney U and chi(2 ) tests were performed . RESULTS At baseline , no significant difference in age or sex distribution , Constant score , or VAS score was detected between treated and nontreated ( control ) patients . Compared with control subjects , treated patients reported a significant decrease in symptoms at 1 month ( mean Constant score , 73.2 + /- 6.2 vs 57.5 + /- 3.9 ; mean VAS score , 4.8 + /- 0.6 vs 9.1 + /- 0.5 ) , 3 months ( mean Constant score , 90.2 + /- 2.6 vs 62.6 + /- 7.2 ; mean VAS score , 3.3 + /- 0.4 vs 7.3 + /- 1.8 ) , and 1 year ( mean Constant score , 91.7 + /- 3.1 vs 78.4 + /- 9.5 ; mean VAS score , 2.7 + /- 0.5 vs 4.5 + /- 0.9 ) ( P < .001 ) . Symptom scores were not significantly different between the groups at 5 years ( mean Constant score , 90.9 + /- 3.6 vs 90.5 + /- 4.8 ; mean VAS score , 2.6 + /- 0.5 vs 2.8 + /- 0.7 ) ( P > or= .795 ) and 10 years ( mean Constant score , 91.8 + /- 5.0 vs 91.3 + /- 9.6 ; mean VAS score , 2.5 + /- 0.6 vs 2.7 + /- 0.6 ) ( P > or= .413 ) . CONCLUSION US-guided percutaneous treatment facilitated prompt shoulder function recovery and pain relief . Treated patients had better outcomes than did nontreated patients at 1 year . However , 5 and 10 years after the procedure , the nontreated group reported outcomes similar to those of the treated group OBJECTIVE The purpose of our study was to evaluate the short- and long-term effectiveness of sonographically guided percutaneous needle aspiration and lavage in calcific tendinitis of the shoulder and to study the progress of calcifications and symptoms in the first year after treatment . MATERIAL S AND METHODS Symptoms and radiologic findings after percutaneous aspiration of calcific tendinitis were prospect ively evaluated in the short and the long term using a shoulder pain and disability index , evaluation of shoulder motion , and a survey of the self-perception by the patients regarding the progress of their disease . RESULTS Sixty-seven consecutive shoulders were treated . A significant improvement was seen in shoulder motion , pain , and disability in the short term and in the long term ( p < 0.0001 ) . One year after treatment , 91 % of shoulders had substantially or completely improved , 64 % had perfect motion , and calcifications on radiography had resolved completely or nearly completely in 89 % . A transitory recurrence was observed approximately 15 weeks after treatment in 44.3 % of shoulders that improved . CONCLUSION Percutaneous needle aspiration and lavage is effective in the short term and in the long term in calcific tendinitis of the shoulder , with results similar to or better than those published for other techniques , and it is only slightly invasive and painful . Progress after treatment may include a transitory period of recurrence of the pain Objective To determine the effectiveness of ultrasound-guided aspiration and lavage in the treatment of patients with calcific tendinosis of the shoulder . Material s and methods Retrospective chart review result ed in 44 patients who were identified as having received ultrasound-guided aspiration of calcific tendinosis of the shoulder between 2000 and 2003 . Of these , 36 patients were interviewed by telephone for pre- and posttreatment assessment of pain , shoulder function , prior shoulder surgery , injury , and prescribed treatment modalities with a follow-up time of 8 months to 3.1 years ( mean = 22.5 months ) . L’Insalata score , numeric rating scale ( NRS ) , and patient satisfaction score served as outcome measures . Results Our criteria for a successful outcome included ( 1 ) 12-point or greater improvement in the L’Insalata shoulder rating question naire , ( 2 ) 2-point or greater improvement in the NRS , ( 3 ) patient satisfaction rating of “ good ” , “ very good ” , or “ excellent ” , ( 4 ) patients ’ willingness to undergo the procedure again if they experienced recurrent symptoms , and ( 5 ) 1 month or less of analgesic medication use after the aspiration procedure . We determined that ultrasound-guided aspiration of calcific tendinosis of the shoulder result ed in a successful outcome for 75 % ( 27/36 ) of patients with a mean 20.2-point improvement in the L’Insalata shoulder rating question naire score and a mean 6.4-point improvement in the NRS ( p < 0.01 ) . Conclusion : This retrospective study suggests that ultrasound-guided aspiration and lavage of calcific shoulder deposits appears to be an efficacious therapeutic modality for treatment of calcific tendinosis . Further studies involving prospect i ve r and omized controlled trials would be helpful to further assess the long-term efficacy of this procedure as a minimally invasive treatment for calcific tendinosis of the shoulder A self-administered question naire was design ed to assess the severity of symptoms related to and the functional status of the shoulder . It includes domains of global assessment , pain , daily activities , recreational and athletic activities , work , satisfaction , and areas for improvement . Each domain is grade d separately and is weighted to arrive at the total score . The over-all scale and each domain were prospect ively tested for validity , reliability , and responsiveness to clinical change . One hundred patients who were seen for evaluation of the shoulder were enrolled in the study . The validity of the scale was demonstrated by moderate-to-high correlation of the domains and individual questions of the Shoulder Rating Question naire with those of the Arthritis Impact Measurement Scales 2 . Validity was supported further by significant correlation of the scores in each domain with the level of satisfaction in that domain and by significantly lower scores in domains that patients selected as areas important for improvement . The over-all scale and each domain were internally consistent ( Cronbach alpha , 0.71 to 0.90 ) . Reproducibility was evaluated by repeated administration of the question naire after a mean of three days to forty patients whose condition was clinical ly stable . Reproducibility of the over-all question naire and individual domains was excellent ( Spearman-Brown index , 0.94 to 0.98 ) . Individual questions were reproducible , with a weighted kappa value of more than 0.7 for each . Responsiveness was evaluated by comparison of the preoperative and postoperative scores of thirty patients who had a satisfactory result one year after an operation on the shoulder . The over-all Shoulder Rating Question naire and each domain were responsive to clinical change as demonstrated by favorable st and ardized response means ( range , 1.1 to 1.9 ) and indices of responsiveness ( range , 1.1 to 2.0 ) . Similar analysis performed for individual diagnostic groups supported the validity , reliability , and responsiveness of the question naire in each group . The self-administered shoulder question naire was found to be valid , reliable , and responsive to clinical change . These qualities should make it a useful instrument for the prospect i ve assessment of the outcome of treatment of disorders related to the shoulder CONTEXT Extracorporeal shock wave therapy ( ESWT ) has been used to treat calcific tendonitis of the shoulder , but trials of ESWT for this purpose have had method ological deficiencies and thus there is limited evidence for its effectiveness . OBJECTIVE To determine whether fluoroscopy-guided ESWT improves function , reduces pain , and diminishes the size of calcific deposits in patients with chronic calcific tendonitis of the shoulder . DESIGN , SETTING , AND PARTICIPANTS Double-blind , r and omized , placebo-controlled trial conducted between February 1997 and March 2001 among 144 patients ( of 164 screened ) recruited from referring primary care physicians , orthopedic surgeons , and sports physicians in 7 orthopedic departments in Germany and Austria . INTERVENTIONS Either high-energy ESWT , low-energy ESWT , or placebo ( sham treatment ) . The 2 ESWT groups received the same cumulative energy dose . Patients in all 3 groups received 2 treatment sessions approximately 2 weeks apart , followed by physical therapy . MAIN OUTCOME MEASURES The primary end point was the change in the mean Constant and Murley Scale ( CMS ) score from baseline to 6 months after the intervention . Secondary end points were changes in the mean CMS scores at 3 and 12 months , as well as changes in self-rated pain and radiographic change in size of calcific deposits at 3 , 6 , and 12 months . RESULTS Of 144 patients enrolled , all completed treatment as r and omized and 134 completed the 6-month follow-up . Both high-energy and low-energy ESWT result ed in significant improvement in the 6-month mean ( 95 % confidence interval [ CI ] ) CMS score compared with sham treatment ( high-energy ESWT : 31.0 [ 26.7 - 35.3 ] points ; low-energy ESWT : 15.0 [ 10.2 - 19.8 ] points ; sham treatment : 6.6 [ 1.4 - 11.8 ] points ; P<.001 for both comparisons ) . Patients who received high-energy ESWT also had significant 6-month CMS improvements compared with those who received low-energy ESWT ( P<.001 ) . We found similar results for both the 3-month and 12-month CMS comparisons , as well as for self-rated pain and radiographic changes at 3 , 6 , and 12 months . CONCLUSIONS Both high-energy and low-energy ESWT appeared to provide a beneficial effect on shoulder function , as well as on self-rated pain and diminished size of calcifications , compared with placebo . Furthermore , high-energy ESWT appeared to be superior to low-energy ESWT A prospect i ve quasir and omized study was performed to compare the effects of surgical extirpation ( Group I , 29 patients )
Output:
| In all articles review ed , the authors reported a good clinical outcome , with many achieving marked improvement in clinical scores or overall satisfaction with the treatment .
Ultrasound-guided barbotage is a safe technique , with a high success rate and low complication rate . |
MS213959 | ***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 —Carotenoids are hypothesized to explain some of the protective effects of fruit and vegetable intake on risk of cardiovascular disease . The present study assessed the protective effects of the oxygenated carotenoid lutein against early atherosclerosis . Methods and Results —Epidemiology : Progression of intima-media thickness ( IMT ) of the common carotid arteries over 18 months was determined ultrasonographically and was related to plasma lutein among a r and omly sample d cohort of utility employees age 40 to 60 years ( n=480 ) . Coculture : The impact of lutein on monocyte response to artery wall cell modification of LDL was assessed in vitro by quantification of monocyte migration in a coculture model of human intima . Mouse models : The impact of lutein supplementation on atherosclerotic lesion formation was assessed in vivo by assigning apoE-null mice to chow or chow plus lutein ( 0.2 % by weight ) and LDL receptor-null mice to Western diet or Western diet plus lutein . IMT progression declined with increasing quintile of plasma lutein ( P for trend=0.007 , age-adjusted;P = 0.0007 , multivariate ) . Covariate-adjusted IMT progression ( mean±SEM ) was 0.021±0.005 mm in the lowest quintile of plasma lutein , whereas progression was blocked in the highest quintile ( 0.004±0.005 mm;P = 0.01 ) . In the coculture , pretreatment of cells with lutein inhibited LDL-induced migration in a dose-dependent manner ( P < 0.05 ) . Finally , in the mouse models , lutein supplementation reduced lesion size 44 % in apoE-null mice ( P = 0.009 ) and 43 % in LDL receptor-null mice ( P = 0.02 ) . Conclusions —These epidemiological , in vitro , and mouse model findings support the hypothesis that increased dietary intake of lutein is protective against the development of early atherosclerosis BACKGROUND AND AIMS Cardiovascular diseases are the major cause of mortality among diabetic patients . The concentration of malondialdehyde ( MDA ) and homocysteine is believed to play a role in cardiovascular diseases . Omega-3 fatty acid supplementation could be effective in some diabetes complications and in the control of the glycemic index . However , it may increase lipid peroxidation . The objective of this study was to determine the effect of omega-3 fatty acids on the concentration of homocysteine and MDA in diabetic patients . METHODS AND RESULTS A r and omized double-blind , placebo-controlled clinical trial was conducted on 81 patients with type 2 diabetes . The patients were r and omly assigned to either the treatment or control groups . Each subject received three capsules of omega-3 fatty acids or a placebo every day for a period of 2months . The two groups were similar in terms of body mass index and food intake . At the beginning of the study and after 2months of supplementation their levels of HbA(1)c , homocysteine , MDA , C-reactive protein ( CRP ) , total cholesterol , LDL-cholesterol and fasting blood sugar ( FBS ) were determined . Due to omega-3 fatty acid supplementation , homocysteine was changed significantly in both treatment and control groups up to -3.10mumol/L and 0.10mumol/L respectively , and HbA(1)c decreased by 0.75 % in the treatment group and increased by 0.26 % in the control group . However , the changes in fasting blood sugar ( FBS ) , malondialdehyde ( MDA ) , C-reactive protein ( CRP ) , total cholesterol and LDL-cholesterol levels were not significant . CONCLUSION The consumption of omega-3 fatty acid supplements ( 3g/day ) for 2months decreases the levels of homocysteine in diabetic patients with no change in FBS , MDA and CRP levels Background —Some epidemiological studies have shown that increased iron stores are associated with increased cardiovascular events . Redox-active iron may contribute to lipid peroxidation , endothelial cell activation , and generation of reactive oxygen species ( especially hydroxyl radical , via Fenton chemistry ) . Increased oxidative stress is associated with impaired action of endothelium-derived nitric oxide in patients with atherosclerosis . Methods and Results —To test the hypothesis that reducing vascular iron stores would reverse endothelial dysfunction , we examined the effects of the iron chelator deferoxamine ( 500 mg intra-arterially over 1 hour ) on vasomotor function in forearm resistance vessels of patients with coronary artery disease by venous occlusion plethysmography . Patients with coronary artery disease had impaired endothelium-dependent vasodilation in response to methacholine compared with healthy control subjects ( P < 0.001 ) . Deferoxamine infusion decreased serum iron levels ( P < 0.001 ) . Deferoxamine improved the blood flow response to methacholine in patients with coronary artery disease ( P < 0.01 by 2-way repeated- measures ANOVA ) but had no effect on the response to sodium nitroprusside . In normal volunteers , deferoxamine had no effect on the response to methacholine . The nitric oxide synthase inhibitor NG-monomethyl-l-arginine abolished augmentation of the methacholine response associated with deferoxamine . The hydroxyl radical scavenger mannitol had no effect on the methacholine response . Conclusions —Deferoxamine improved nitric oxide – mediated , endothelium-dependent vasodilation in patients with coronary artery disease . These results suggest that iron availability contributes to impaired nitric oxide action in atherosclerosis BACKGROUND Oxidative stress and inflammation are crucial in atherogenesis . alpha-Tocopherol is both an antioxidant and an antiinflammatory agent . OBJECTIVE We evaluated the effect of RRR-alpha-tocopherol supplementation on carotid atherosclerosis in patients with stable coronary artery disease ( CAD ) on drug therapy . DESIGN R and omized , controlled , double-blind trial compared RRR-alpha-tocopherol ( 1200 IU/d for 2 y ) with placebo in 90 patients with CAD . Intimal medial thickness ( IMT ) of both carotid arteries was measured by high-resolution B-mode ultrasonography at 0 , 1 , 1.5 , and 2 y. At 6-mo intervals , plasma alpha-tocopherol concentrations , C-reactive protein ( CRP ) , LDL oxidation , monocyte function ( superoxide anion release , cytokine release , and adhesion to endothelium ) , and urinary F(2)-isoprostanes were measured . RESULTS alpha-Tocopherol concentrations were significantly higher in the alpha-tocopherol group but not in the placebo group . High-sensitivity CRP concentrations were significantly lowered with alpha-tocopherol supplementation than with placebo ( 32 % ; P < 0.001 ) . alpha-Tocopherol supplementation significantly reduced urinary F(2)-isoprostanes ( P < 0.001 ) and monocyte superoxide anion and tumor necrosis factor release compared with baseline and placebo ( P < 0.001 ) . No significant difference was observed in the mean change in total carotid IMT in the placebo and alpha-tocopherol groups . In addition , no significant difference in cardiovascular events was observed ( P = 0.21 ) . CONCLUSIONS High-dose RRR-alpha-tocopherol supplementation in patients with CAD was safe and significantly reduced plasma biomarkers of oxidative stress and inflammation but had no significant effect on carotid IMT during 2 INTRODUCTION Observational studies have suggested a causal relationship between hyperhomocysteinemia and cardiovascular complications such as stroke and ischemic heart disease . The Homocysteine Lowering Trialists ' Collaboration has shown that daily administration of folic acid can significantly decrease homocysteine levels up to 25 % . Aim of this study was to investigate the effect of daily supplementation of folic acid ( 5 mg ) on IMT after 18 months of treatment in patients with at least one cardiovascular risk factor . METHODS We enrolled 103 patients with at least one cardiovascular risk factor who were r and omized to receive either a daily dose of 5 mg folic acid ( group I , n=53 ) or placebo ( group II , n=50 ) for 18 months . RESULTS After 18 months of folic acid supplementation , homocysteine levels were significantly reduced in the active treatment group compared to a non-significant increase in the placebo group . Folic acid levels were markedly increased in the former group and non-significantly reduced in the latter . Significant regression of carotid IMT was observed ( 0.961+/-0.092 to 0.933+/-0.077 mm , p<0.001 ) compared to significant IMT progression in the placebo group ( 0.964+/-0.099 to 0.984+/-0.094 mm ) . CONCLUSION Folic acid supplementation results in significant IMT reduction after 18 months in patients with at least one cardiovascular risk OBJECTIVE Hyperhomocysteinemia is an independent risk factor for atherosclerotic vascular disease in chronic hemodialysis patients . This stratified r and omized controlled trial was design ed to measure the effect of high dose oral vitamin B6 , vitamin B12 , and folic acid on homocysteine levels , and to evaluate the effect on atherosclerosis as measured by Intima-Media Thickness ( IMT ) of carotid arteries . MATERIAL AND METHOD Fifty-four chronic hemodialysis patients with hyperhomocysteinemia were r and omized to receive oral 15 mg folic acid , 50 mg vitamin B6 , and 1 mg vitamin B12 daily ( treatment group ) or oral 5 mg folic acid alone ( control group ) for 6 months . Homocysteine level and IMT were measured in both groups . RESULTS At 6 months , homocysteine levels in the treatment group were significantly reduced from 27.94 + /- 8.54 to 22.71 + /- 3.68 mmol/l ( p = 0.009 ) and were not significantly increased from 26.81 + /- 7.10 to 30.82 + /- 8.76 mmol/l in control group ( p = 0.08 ) . Mean difference between both groups was statistically significant ( p = 0.002 ) . There was no significant difference of IMT of carotid arteries , however , a tendency that the treatment group would have less thickness was observed ( 0.69 + /- 0.29 mm and 0.62 + /- 0.16 mm , p = 0.99 ) . CONCLUSION Treatment of hyperhomocysteinemia in chronic hemodialysis patients with daily oral 15 mg folic acid , 50 mg vitamin B6 , and 1 mg vitamin B12 for 6 months decreases homocysteine levels and tends to reduce IMT of carotid arteries . A long term study for the prevention of atherosclerosis is warranted Abstract —Although a number of epidemiological studies have evaluated the association between & bgr;-carotene and the risk of cardiovascular diseases , there has been little research on the role of lycopene , an acyclic form of & bgr;-carotene , with regard to the risk of cardiovascular disease . We investigated the relationship between plasma concentrations of lycopene and intima-media thickness of the common carotid artery wall ( CCA-IMT ) in 520 middle-aged men and women ( aged 45 to 69 years ) in eastern Finl and . They were examined from 1994 to 1995 at the baseline of the Antioxidant Supplementation in Atherosclerosis Prevention ( ASAP ) study , a r and omized trial concerning the effect of vitamin E and C supplementation on atherosclerotic progression . The subjects were classified into 2 categories according to the median concentration of plasma lycopene ( 0.12 & mgr;mol/L in men and 0.15 & mgr;mol/L in women ) . Mean CCA-IMT of the right and left common carotid arteries was 1.18 mm in men and 0.95 mm in women with plasma lycopene levels lower than the median and 0.97 mm in men ( P < 0.001 for difference ) and 0.89 mm in women ( P = 0.027 for difference ) with higher levels of plasma lycopene . In ANCOVA adjusting for cardiovascular risk factors and intake of nutrients , in men , low levels of plasma lycopene were associated with a 17.8 % increment in CCA-IMT ( P = 0.003 for difference ) . In women , the difference did not remain significant after the adjustments . We conclude that low plasma lycopene concentrations are associated with early atherosclerosis , manifested as increased CCA-IMT , in middle-aged men living in eastern Finl and Background —Activation of the renin-angiotensin-aldosterone system
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| RESULTS Although not all studies found consistent results , the weight of the evidence suggests that high intakes and /or circulatory levels of magnesium , as well as vitamin D and the vitamin B group , may be associated with lower carotid IMT or reduced progression of carotid IMT .
The majority of studies did not find any significant association between vitamin E and C and carotid IMT .
Less evidence was available for associations of retinol , zinc , and iron with carotid IMT .
CONCLUSIONS In general , the current evidence concerning micronutrient intake and carotid IMT is largely inconclusive .
Pragmatic clinical trials are required to determine whether dietary or supplemental intake of specific micronutrients alters carotid IMT , which is a surrogate measure of cardiovascular risk |
MS213960 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
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Input: Study Design Prospect i ve , r and omized , controlled . Level 1 evidence . Objective To report functional outcomes at 48 months follow-up on prospect ively r and omized patients to either the Bryan cervical disc prosthesis or anterior cervical discectomy and fusion ( ACDF ) at a single site . Summary of Background Data Surgical treatment of cervical disc pathology can involve discectomy and fusion ( ACDF ) , the gold st and ard technique . The safety and effectiveness of this procedure has been established and demonstrated in the literature , however , limitations have evolved and alternatives such as disc replacement are being investigated . Intervertebral disc replacement is design ed to preserve motion , both at affected and adjacent levels avoiding limitations of fusion such as adjacent level degeneration . New onset degenerative changes and possible recurring neurologic symptoms may be deferred or eliminated with cervical disc replacement . A recent multicenter trial with 24 months follow-up has shown the Bryan disc to compare favorably with ACDF . Continued follow-up is needed to further evaluate and compare functional outcomes in both these cohorts . Methods A total of 47 patients were enrolled at our site as part of an ongoing multicenter prospect ively r and omized study investigating ACDF versus Bryan cervical disc prosthesis . Functional outcomes are now reported at 48 months follow-up for our cohort of participants . Neck disability index score ( NDI ) , VAS neck and arm and SF-36 both physical and mental as well as complications and reoperations will be reported . Results Functional outcome data collected at routine follow-up for 48-months has favorably demonstrated improved functional outcomes for NDI , neck/arm pain VAS scores , and the SF-36 physical/mental health component scores for the Bryan arthroplasty and ACDF cohorts . The NDI scores for the Bryan arthroplasty preoperatively was 51 and at 48 months 10 . For ACDF preoperative NDI score was also 51 and at 48 months 16.7 . At 48 months NDI success , measured by ≥15 points NDI improvement demonstrated a 93.3 % success for Bryan arthroplasty and an 82.4 % success for ACDF . VAS neck pain scores for the Bryan arthroplasty preoperatively was 76.2 and at 48 months was 13.6 . VAS neck pain scores for ACDF preoperatively was 80.6 and at 48 months was 28.1 . Arm Pain scores were also measured and for the Bryan arthroplasty preoperatively measured 78.8 and at 48 months 10.8 . For ACDF arm pain scores preoperatively measured 77.1 and at 48 months 21.7 . These outcomes have not been associated with any degradation of outcome measures from 2 to 4 years . During the 48 months of follow-up at our institution we also report 6 secondary surgeries in our control group ( ACDF ) and only 1 in our investigational group ( Bryan ) . Of the 6 surgeries in the control group performed , 3 or 12 % to date were for adjacent level degenerative disease and 1 or 4 % for remote level degenerative disc disease . The remaining 2 surgeries were performed on the same patient for a pseudarthrosis . In the investigational group there was only 1 secondary surgery performed to date for adjacent level disease 5 % . Conclusions At 48 months , cervical arthroplasty with the Bryan cervical disc prosthesis continues to compare favorably to ACDF at our institution . There has been no degradation of functional outcomes from 24 to 48 months for NDI , VAS of neck and arm , and SF-36 . There has been a lower incidence of secondary surgeries for the Bryan arthroplasty cohort to date OBJECT Spinal arthroplasty is becoming more widely performed in the treatment of degenerative cervical disc disease . Although this new technology may offer benefits over arthrodesis , it also requires that the surgeon acquire new operative techniques , and new potential complications are introduced . To determine the incidence and distribution of perioperative complications , the authors analyzed their early data obtained in a series of patients treated with the Bryan Cervical Disc prosthesis . METHODS The authors prospect ively recorded operative data , complications , and clinical and radiographic outcome data in all patients treated with Bryan prosthesis-based arthroplasty at two tertiary care centers since 2001 . Patients underwent st and ard anterior cervical discectomy followed by one- to three-level arthroplasty . Ninety-six discs were implanted in 74 patients . The perioperative complication rate was 6.2 % per treated level . In one patient a retropharyngeal hematoma developed , requiring evacuation . Neurological worsening occurred in three patients . Intraoperative migration of the prosthesis was observed in one two-level case , whereas delayed migration occurred in one patient with postoperative segmental kyphosis . In another patient with severe postoperative segmental kyphosis , revision was required with a customized lordotic prosthesis . Heterotopic ossification and spontaneous fusion occurred in two cases ; motion was preserved in the remaining 94 prostheses . Partial dislocation of the prosthesis in extension occurred in one patient with preoperative segmental hypermobility , the first reported failure of a Bryan prosthesis . Twenty-five percent of patients reported neck and shoulder pain during the late follow-up period . There was a trend toward increased kyphosis of the C2 - 7 curvature postoperatively . CONCLUSIONS The Bryan prosthesis was effective in maintaining spinal motion . Major perioperative and device-related complications were infrequent Study Design . R and omized controlled study . Objective . To compare the rates of adverse events associated with disc arthroplasty versus those of anterior cervical discectomy and arthrodesis with allograft and plate . Summary of Background Data . Cervical disc arthroplasty as a substitute for fusion has been developed to maintain motion and , theoretically , prevent adjacent segment degeneration . Currently , cervical arthroplasty devices are undergoing clinical testing for safety and efficacy . The evaluation of safety is performed by critical analysis of all adverse occurrences following surgery to determine if the new device has a beneficial risk profile for the patient . Methods . Adverse events associated with Bryan Disc arthroplasty and arthrodesis were compared in a prospect i ve r and omized study . Four hundred sixty-three ( 463 ) patients having cervical radiculopathy and or myelopathy at a single level were treated at 31 sites . A total of 242 patients received the disc and 221 patients had anterior cervical discectomy and fusion . All patients were evaluated before surgery and at 1.5 , 3 , 6 , 12 , and 24 months after surgery . Adverse events were recorded concurrently and categorized by severity and as medically or surgically related . Results . No differences in overall medical events occurred between groups . Surgically related events occurred more frequently in the investigational group secondary to more complaints of postoperative dysphagia and late medical events occurred more frequently in the investigational patients . However , the more severe World Health Organization Grade 3 and 4 events occurred more frequently in the arthrodesis patients related to treatment of pseudarthrosis and persistent symptoms . Significantly , more cervical spine reoperations occurred in the fusion group . Only one spinal cord injury occurred and it was in the arthrodesis group and no patients had deep infection or death related to either procedure . Conclusion . Bryan cervical disc replacement and anterior cervical fusion are both safe procedures with a low incidence of significant adverse events related to the procedure . Statistically , more serious adverse events and reoperations occurred in the fusion group while a greater number of less serious surgically related events were seen in the investigational group BACKGROUND CONTEXT The Neck Disability Index ( NDI ) , the short form-36 ( SF-36 ) physical component summary ( PCS ) , and pain scales for arm and neck pain are increasingly used to evaluate treatment effectiveness after cervical spine surgery . The minimum clinical ly important difference ( MCID ) is a threshold of improvement that is clinical ly relevant to the patient . However , the true goal is to provide the patient with a substantial clinical benefit ( SCB ) . PURPOSE This study determines the MCID and SCB using common anchor-based methods for NDI , PCS , and pain scales for arm and neck pain in patients undergoing cervical spine fusion for degenerative disorders . STUDY DESIGN / SETTING The study setting is a longitudinal cohort in a multisurgeon spine specialty clinic . PATIENT SAMPLE The sample comprises 505 patients who underwent a cervical fusion for degenerative spine conditions and who have prospect ively collected outcome scores with a minimum 1-year follow-up . OUTCOME MEASURES The outcome measures of the study were NDI , SF-36 , and numeric rating scales for arm and neck pain . METHODS The MCID and SCB values for NDI , PCS , and pain scales for arm and neck pain were determined using receiver operating characteristic ( ROC ) curve analysis with the Health Transition Item of the SF-36 as an anchor . The Health Transition Item asks a patient " Compared to one year ago , how would you rate your health in general now ? " with answers ranging from " Much Better , " " Somewhat Better , " " About the Same , " " Somewhat Worse , " to " Much Worse . " An ROC curve was constructed for each measure . The ROC curve-derived MCID was the change score with equal sensitivity and specificity to distinguish the " Somewhat Better " from the " About the Same " patients . The ROC curve-derived SCB was the change score with equal sensitivity and specificity to distinguish the " Much Better " from the " Somewhat Better " patients . Distribution-based methods including the st and ard error of the mean and the minimum detectable change were also used to calculate MCID . RESULTS The calculated MCID is 7.5 for the NDI , 4.1 for SF-36 PCS , and 2.5 for arm and neck pain . The calculated SCB is 9.5 for the NDI , 6.5 for SF-36 PCS , and 3.5 for arm and neck pain . CONCLUSIONS Patients with an eight-point decrease in NDI , a 4.1-point increase in PCS , and a three-point decrease in arm or neck pain can detect a minimally clinical ly important change . Patients with a 10-point decrease in NDI , a 6.5-point increase in PCS , and a four-point decrease in arm or neck pain can detect an SCB after cervical spine fusion Study Design . Prospect i ve , r and omized , controlled study of patients with lumbar disc herniations , operated either in a full-endoscopic or microsurgical technique . Objective . Comparison of results of lumbar discectomies in full-endoscopic interlaminar and transforaminal technique with the conventional microsurgical technique . Summary of Background Data . Even with good results , conventional disc operations may result in subsequent damage due to trauma . Endoscopic techniques have become the st and ard in many areas because of the advantages they offer intraoperatively and after surgery . With the transforaminal and interlaminar techniques , 2 full-endoscopic procedures are available for lumbar disc operations . Methods . One hundred seventy-eight patients with full-endoscopic or microsurgical discectomy underwent follow-up for 2 years . In addition to general and specific parameters , the following measuring instruments were used : VAS , German version North American Spine Society Instrument , Oswestry Low-Back Pain Disability Question naire . Results . After surgery 82 % of the patients no longer had leg pain , and 14 % had occasional pain . The clinical results were the same in both groups . The recurrence rate was 6.2 % with no difference between the groups . The full-endoscopic techniques brought significant advantages in the following areas : back pain , rehabilitation , complications , and traumatization . Conclusion . The clinical results of the full-endoscopic technique are equal to those of the microsurgical technique . At the same time , there are advantages in the operation technique and reduced traumatization . With the surgical devices and the possibility of selecting an interlaminar or posterolateral to lateral transforaminal procedure , lumbar disc herniations outside and insidethe spinal canal can be sufficiently removed using the full-endoscopic technique , when taking the appropriate criteria into account . Full-endoscopic surgery is a sufficient and safe supplementation and alternative to microsurgical procedures BACKGROUND Although there have been case reports describing the use of cervical disc arthroplasty for the treatment of myelopathy , there is a concern that motion preservation may maintain microtrauma to the spinal cord , negatively affecting the clinical results . As we are not aware of any studies on the use of arthroplasty in this scenario , we performed a cross-sectional analysis of two large , prospect i ve , r and omized multicenter trials to evaluate the efficacy of cervical disc arthroplasty for the treatment of myelopathy . METHODS The patients in the current study were a cohort of patients who were enrolled in the United States Food and Drug Administration Investigational Device Exemption studies of the Prestige ST and Bryan disc replacements ( Medtronic , Memphis , Tennessee ) . The inclusion criteria were myelopathy and spondylosis or disc herniation at a single level from C3 to C7 . Clinical outcome measures were collected preoperatively and at six weeks , three months , six months , twelve months , and twenty-four months postoperatively . RESULTS A total of 199 patients were included in the present study ; 106 patients ( 53 % ) underwent arthroplasty , whereas ninety-three ( 47 % ) underwent arthrodesis . The Neck Disability Index , Short Form-36 scores , and specific arm and neck pain scores improved significantly from baseline at all time points . Patients in all four groups had improvement in the postoperative neurological status and gait function ; at twenty-four months after surgery , 90 % ( 95 % confidence interval , 77.8 % to 96.6 %
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| Patients with PTUCD arthroplasty had also less radiological degenerative changes at the upper adjacent level .
Overall adverse events were twice more frequent in patients with ACDF .
The rate of revision surgery including both adjacent and index level was slightly higher in patients with ACDF , showing no statistically significant difference .
Conclusions According to this review , PTUCD arthroplasty showed a global superiority to ACDF in clinical outcomes .
The impact of both surgical techniques on the cervical spine ( radiological spine deterioration and /or complications ) was more severe in patients undergoing ACDF .
However , the rate of revision surgeries at any cervical level was equivalent for ACDF and PTUCD arthroplasty |
MS213961 | ***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 In metastatic colorectal cancer , phase III studies have demonstrated the superiority of fluorouracil ( FU ) with leucovorin ( LV ) in combination with irinotecan or oxaliplatin over FU + LV alone . This phase III study investigated two sequences : folinic acid , FU , and irinotecan ( FOLFIRI ) followed by folinic acid , FU , and oxaliplatin ( FOLFOX6 ; arm A ) , and FOLFOX6 followed by FOLFIRI ( arm B ) . PATIENTS AND METHODS Previously untreated patients with assessable disease were r and omly assigned to receive a 2-hour infusion of l-LV 200 mg/m(2 ) or dl-LV 400 mg/m(2 ) followed by a FU bolus 400 mg/m(2 ) and 46-hour infusion 2,400 to 3,000 mg/m(2 ) every 46 hours every 2 weeks , either with irinotecan 180 mg/m(2 ) or with oxaliplatin 100 mg/m(2 ) as a 2-hour infusion on day 1 . At progression , irinotecan was replaced by oxaliplatin ( arm A ) , or oxaliplatin by irinotecan ( arm B ) . RESULT Median survival was 21.5 months in 109 patients allocated to FOLFIRI then FOLFOX6 versus 20.6 months in 111 patients allocated to FOLFOX6 then FOLFIRI ( P = .99 ) . Median second progression-free survival ( PFS ) was 14.2 months in arm A versus 10.9 in arm B ( P = .64 ) . In first-line therapy , FOLFIRI achieved 56 % response rate ( RR ) and 8.5 months median PFS , versus FOLFOX6 which achieved 54 % RR and 8.0 months median PFS ( P = .26 ) . Second-line FOLFIRI achieved 4 % RR and 2.5 months median PFS , versus FOLFOX6 which achieved 15 % RR and 4.2 months PFS . In first-line therapy , National Cancer Institute Common Toxicity Criteria grade 3/4 mucositis , nausea/vomiting , and grade 2 alopecia were more frequent with FOLFIRI , and grade 3/4 neutropenia and neurosensory toxicity were more frequent with FOLFOX6 . CONCLUSION Both sequences achieved a prolonged survival and similar efficacy . The toxicity profiles were different The present exploratory analysis examined the efficacy , safety , and quality -of-life effects of everolimus ( EVE ) + exemestane ( EXE ) in the subgroup of patients in BOLERO-2 whose last treatment before study entry was in the (neo)adjuvant setting . In BOLERO-2 , patients with hormone-receptor-positive ( HR+ ) , human epidermal growth factor receptor-2-negative ( HER2− ) advanced breast cancer recurring/progressing after a nonsteroidal aromatase inhibitor ( NSAI ) were r and omly assigned ( 2:1 ) to receive EVE ( 10 mg/day ) + EXE ( 25 mg/day ) or placebo ( PBO ) + EXE . The primary endpoint was progression-free survival ( PFS ) by local assessment . Overall , 137 patients received first-line EVE + EXE ( n = 100 ) or PBO + EXE ( n = 37 ) . Median PFS by local investigator assessment nearly tripled to 11.5 months with EVE + EXE from 4.1 months with PBO + EXE ( hazard ratio = 0.39 ; 95 % CI 0.25–0.62 ) , while maintaining quality of life . This was confirmed by central assessment ( 15.2 vs 4.2 months ; hazard ratio = 0.32 ; 95 % CI 0.18–0.57 ) . The marked PFS improvement in patients receiving EVE + EXE as first-line therapy for disease recurrence during or after (neo)adjuvant NSAI therapy supports the efficacy of this combination in the first-line setting . Furthermore , the results highlight the potential benefit of early introduction of EVE + EXE in the management of HR+ , HER2− advanced breast cancer in postmenopausal patients BACKGROUND The BOLERO-2 study previously demonstrated that adding everolimus ( EVE ) to exemestane ( EXE ) significantly improved progression-free survival ( PFS ) by more than twofold in patients with hormone-receptor-positive ( HR(+ ) ) , HER2-negative advanced breast cancer that recurred or progressed during/after treatment with nonsteroidal aromatase inhibitors ( NSAIs ) . The overall survival ( OS ) analysis is presented here . PATIENTS AND METHODS BOLERO-2 is a phase III , double-blind , r and omized international trial comparing EVE 10 mg/day plus EXE 25 mg/day versus placebo ( PBO ) + EXE 25 mg/day in postmenopausal women with HR(+ ) advanced breast cancer with prior exposure to NSAIs . The primary end point was PFS by local investigator assessment ; OS was a key secondary end point . RESULTS At the time of data cutoff ( 3 October 2013 ) , 410 deaths had occurred and 13 patients remained on treatment . Median OS in patients receiving EVE + EXE was 31.0 months [ 95 % confidence interval ( CI ) 28.0 - 34.6 months ] compared with 26.6 months ( 95 % CI 22.6 - 33.1 months ) in patients receiving PBO + EXE ( hazard ratio = 0.89 ; 95 % CI 0.73 - 1.10 ; log-rank P = 0.14 ) . Post study treatments were received by 84 % of patients in the EVE + EXE arm versus 90 % of patients in the PBO + EXE arm . Types of post study therapies were balanced across arms , except for chemotherapy ( 53 % EVE + EXE versus 63 % PBO + EXE ) . No new safety concerns were identified . CONCLUSIONS In BOLERO-2 , adding EVE to EXE did not confer a statistically significant improvement in the secondary end point OS despite producing a clinical ly meaningful and statistically significant improvement in the primary end point , PFS ( 4.6-months prolongation in median PFS ; P < 0.0001 ) . Ongoing translational research should further refine the benefit of mTOR inhibition and related pathways in this treatment setting . TRIAL REGISTRATION NUMBER NCT00863655 Background Few targeted therapies ( TTs ) are registered for sarcoma treatment despite numerous phase II studies and yet there are potential treatment options for patients after st and ard treatment escape . The French Sarcoma Group - Bone Tumor Study Group ( GSF-GETO ) created a national registry to evaluate the outcome of patients treated with off-label TTs . Methods Every consecutive sarcoma-patient receiving an off-label TT outside a clinical trial was included . The objective was to describe this patient efficacy and safety data in routine practice . Results From October 2008 to October 2011 , 249 patients in 24 centers received 278 treatment lines with TTs . Twenty-five histological subtypes were included : most frequent were leiomyosarcoma ( n = 48 , receiving sorafenib in 63 % , and sunitinib in 27 % ) , GIST ( n = 39 , receiving sorafenib in 79 % ) , and angiosarcoma ( n = 18 , receiving sorafenib in 78 % ) . The overall response rate to TTs was 15 % ( 95 % CI [ 10,6 - 20,2 ] ) , the disease control rate at 2 months was 59 % . The median progression-free survival was 4,1 months ( IC 95 % [ 3,2 - 4,8 ] ) . Three complete responses were observed . No toxic death occurred , grade 3 and 4 toxicities were reported in 74 ( 27 % ) and 14 patients ( 5 % ) respectively . Conclusion Off-label TTs can be used for sarcoma patients in routine practice with an acceptable toxicity profile and efficacy similar to that reported in non-r and omized clinical trials 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 ] . ) BACKGROUND Postmenopausal women with hormone receptor-positive ( HR(+ ) ) breast cancer in whom disease progresses or there is recurrence while taking a nonsteroidal aromatase inhibitor ( NSAI ) are usually treated with exemestane ( EXE ) , but no single st and ard of care exists in this setting . The BOLERO-2 trial demonstrated that adding everolimus ( EVE ) to EXE improved progression-free survival ( PFS ) while maintaining quality of life when compared with EXE alone . Because many women with HR(+ ) advanced breast cancer are elderly , the tolerability profile of EVE plus EXE in this population is of interest . PATIENTS AND METHODS BOLERO-2 , a phase III r and omized trial , compared EVE ( 10 mg/d ) and placebo ( PBO ) , both plus EXE ( 25 mg/d ) , in 724 postmenopausal women with HR(+ ) advanced breast cancer recurring/progressing after treatment with NSAIs . Safety and efficacy data in elderly patients are reported at 18-month median follow-up . RESULTS Baseline disease characteristics and treatment histories among the elderly subsets ( ≥ 65 years , n = 275 ; ≥ 70 years , n = 164 ) were generally comparable with younger patients . The addition of EVE to EXE improved PFS regardless of age ( hazard ratio , 0.59 [ ≥ 65 years ] and 0.45 [ ≥ 70 years ] ) . Adverse events ( AEs ) of special interest ( all grade s ) that occurred more frequently with EVE than with PBO included stomatitis , infections , rash , pneumonitis , and hyperglycemia . Elderly EVE-treated patients had similar incidences of these AEs as did younger patients but had more on-treatment deaths . CONCLUSION Adding EVE to EXE offers substantially improved PFS over EXE and was generally well tolerated in elderly patients with HR(+ ) advanced breast cancer . Careful monitoring and appropriate dose reductions or interruptions for AE management are recommended during treatment with EVE in this patient population BACKGROUND Disease progression in patients with HER2-positive breast cancer receiving trastuzumab might be associated with activation of the PI3K/Akt/mTOR intracellular signalling pathway . We aim ed to assess whether the addition of the mTOR inhibitor everolimus to trastuzumab might restore sensitivity to tr
Output:
| In comparison with NCT alone , NCT plus bevacizumab significantly improve ORR and R0 hepatic resection rate but not for hepatic resection rate . |
MS213962 | ***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 whether residents perceived oral , face-to-face feedback about their continuity clinic performance as better than a similar , written version . DESIGN : Single-blind , r and omized controlled trial . SETTING : Two university-based , internal medicine residency clinics . PARTICIPANTS : All 68 internal medicine and combined program ( medicine-pediatrics , medicine-psychiatry , medicine-neurology , and preliminary year ) residents and their clinic preceptors . MEASUREMENTS AND MAIN RESULTS : Residents at each program were separately r and omized to oral or written feedback sessions with their clinic preceptors . The oral and written sessions followed similar , structured formats . Both groups were later sent question naires about aspects of the clinic . Sixty-five ( 96 % ) of the residents completed the question naire . Eight of the 19 questions dealt with aspects of feedback . A feedback scale was developed from the survey responses to those eight questions ( α=.86 ) . There were no significant differences in the responses to individual questions or in scale means ( p>.20 ) between the two feedback groups . When each university was analyzed separately , one had a higher scale mean ( 3.10 vs 3.57 , p=.047 ) , but within each university , there were no differences between the oral and written feedback groups ( p>.20 ) . CONCLUSIONS : No differences were observed between the oral and written feedback groups . In attempting to provide better feedback to their residents , medical educators may better apply their efforts to other aspects , such as the frequency of their feedback , rather than the form of its delivery Second-year medical students performed a head-to-toe screening physical examination on trained patient instructors ( PIs ) as a high-stakes examination before beginning clinical clerkships . PIs completed a 138-item checklist and instructed the students in the proper performance of any incorrectly executed or omitted items . To assess the accuracy of the PI ratings , ' monitor ' PIs watching the encounter by video completed checklists for 11 retests of failed students in 2001 and for 28 r and omly selected encounters in 2002 . Checklist-level discrepancies measured by mean absolute checklist difference were 8 % in 2001 and 9 % in 2002 . Case-level mean difference between raters in 2002 was -2.9 % . The inter-rater reliability for a single rater , estimated by the intra-class correlation coefficient for total encounter scores , was 0.95 . The assessment and feedback were well received by the students . The Head-to-Toe examination provides a reliable assessment of a student 's ability to carry out a complete screening physical examination . Patient instructors can be trained to acceptable accuracy and reliability despite the length and complexity of the exercise , and can provide effective feedback and teaching targeted to individual student deficiencies Learning proper techniques in physical examinations is m and atory for a physician . Although students may examine each other in early training , examination of the female pelvis does not readily conform to this reciprocity . A r and omized study was conducted , comparing teaching methods utilizing professional patients or plastic models . Training on a professional patient significantly increased a student 's chance of palpating one or both ovaries , reduced the student 's anxiety about performing a pelvic examination , and may have improved the student 's gentleness . Costs of the professional patient method were minimal . It is recommended that teaching pelvic examinations with the professional patient replace teaching on the plastic model PURPOSE : To evaluate two smoking-cessation practice exercises , one using st and ardized patients ( SPs ) , the other using role playing by medical students . METHOD : In the spring of 1994 all 120 first-year University of California , San Francisco , School of Medicine Students were given lectures on the health effects of smoking and how physicians can help patients quit . Afterward some of the students were r and omly assigned to two groups in which to practice counseling patients : Group 1 ( n = 35 ) used SPs , Group 2 ( n = 37 ) used role playing . Each of the Group 1 students practice d smoking-cessation techniques with an SP ; the SP evaluated the student on cognitive and communication skills , assigned an overall rating , and provide feedback using a st and ardized form . The Group 2 students ( as well as the 48 students not assigned to a group ) role-played in pairs and used the same form to provide feedback . All the students evaluated their respective practice practice s. Two weeks later 24 Group 1 and 31 Group 2 students participated in a clinic-skills- assessment exercise using SPs . As in the Group 1 practice exercise , each student was evaluated by an SP on cognitive and communication skills and assigned an overall rating . Data were analyzed through a number of statistical methods . The cost of the SP program was determined . RESULTS : The Group 1 students rated their practice exercise much more favorably than did the Group 2 students . However , there was no significant difference between the groups in their ratings by the SPs on the clinical -skills- assessment exercise . The use of SPs cost a great deal more than did the use of role playing . CONCLUSION : Although the students rated the SPs higher than they did the role playing , the two tools produced similar levels of skills attainment . The data suggest that having students practice smoking-cessation techniques through role playing may be as effective as using the more extensive SPs Purpose To compare two methods of teaching physical assessment , a traditional faculty-taught course and a course with components taught by specially trained st and ardized patients ( SPs ) , with respect to students ' performances and costs . Method Medical students in their second year and without preliminary course work in physical assessment were taught by faculty-led small groups . Students in their first year were taught by faculty-led lecture — demonstrations and exercises led by physical examination teaching associates ( PETAs ) . Both groups of students were tested with a performance-based examination that involved six identical stations . The costs of both courses were calculated using faculty and SP salaries . Results There was no difference in students ' performances on two of the stations , those involving the eye and abdominal examinations . The class that had been taught by PETAs , however , demonstrated a statistically significant performance advantage on the remaining four stations . The cost saving from using the PETAs was conservatively estimated at $ 24,155 . Conclusion Specially trained SPs can effectively teach the normal physical examination to medical students and are a less expensive alternative to traditional faculty small-group teaching methods The area of communication skills in adolescent medicine is emerging as a distinct and important part of the undergraduate curriculum . An appropriate level of confidence in dealing with the adolescent population is deemed a necessary educational requirement . Skills in psychosocial communication with adolescents differ from those required for younger patients and adults ; they include discussing confidentiality and adolescent risk-taking activities . Simulated patients can be used effectively in teaching and evaluating of communication skills . However , there is no report of using adolescent simulated patients to teach communication skills . The evidence available is inconclusive regarding the teaching time required to promote retention of communication skills , although a recent review suggests that one day ’s training or less is not effective . Long-term retention of these skills has been supported by only one paper , suggesting a need to follow students over time to ascertain the effect of communication skills training . Our study addressed two questions : ( 1 ) does feedback from a simulated adolescent patient and simulated mother lead to improvements in fourth-year medical students ’ psychosocial interviewing of adolescent patients ? and ( 2 ) does this skill persist following the intervention A class of 100 second-year medical students was r and omly divided into two groups for instruction in the techniques of the gynecologic examination . Each group received a lecture and a demonstration film . The control group then had practical instruction on office or clinic patients . The study group was instructed by specially trained clinical teaching associates who acted both as professional patients and as teachers . After practice in clinics and offices , both groups received a common evaluation by gynecologists and teaching associates . Students who were instructed by clinical teaching associates performed better on subsequent pelvic examinations and demonstrated superior communications skills compared with the control group Two nonphysician mothers were each trained to give a consistent and authentic history of a child 's common medical problem . At the beginning of a Pediatric Clerkship , one half the students were r and omly assigned to interview one of the trained mothers . The interviews were videotaped and then replayed in an evaluative feedback session with each student . At the end of the clerkship these students were rated significantly higher on the process of interviewing than those students who did not have the initial evaluative feedback session OBJECTIVES Facing dramatic reductions of inpatient beds and fewer faculty tutors , the Queen 's University medical school has had to consider alternatives to the traditional inpatient encounter for the early acquisition of clinical skills . The purpose of this study was to investigate the feasibility and impact on students of a model for a first-year clinical skills course , using exclusively st and ardized patients in place of in patients , and using a smaller ratio of faculty to students . DESIGN Twenty volunteers were selected from the first-year class of 75 students to participate as the experimental group . The remaining 55 students formed the control group . SETTING Queen 's University medical school , Ontario , Canada . SUBJECTS First-year medical students . RESULTS In measures of student satisfaction with the amount of performance feedback received during the course , there was a non-significant trend towards greater satisfaction among the experimental group compared to the control group . This occurred despite a tutor to student ratio of 1.5:10 in the experimental group compared to 3:10 in the control group . In the student evaluation of their tutors , mean scores for the two groups were 4.28 for the experimental group and 4 . 06 for the control group ( P = 0.10 ) . The mean OSCE scores for the two groups were 76.4 for the experimental group and 76.5 for the control group ( P = 0.93 ) . There is no practical or statistical difference in either of these two scores . CONCLUSIONS We conclude that this new model is feasible , was well received by the students and that the reduced tutor to student ratio and lack of inpatient encounters did not appear to adversely affect their learning The increasing difficulty in obtaining appropriate hospitalized patients to give enlarging classes of medical students their first exposure to abnormal physical findings has led to the development of an instructor-patient program . Sixteen community residents with relatively stable respiratory , cardiovascular , musculoskeletal , or neurological findings were recruited and trained as instructor- patients to teach the technical elements of the examination of the affected organ system . Evaluation of the technical skills of 46 second-year students trained by instructor- patients and those of 41 r and omly selected students trained in these skills by physician instructors demonstrated that the two have comparable technical skills five to eight weeks after the training sessions . Faculty recruitment , instructor-patient recruitment and training , and evaluation are discussed PURPOSE : This r and omized controlled study compared the interviewing skills of first-year medical students receiving feedback primarily from st and ardized patients ( SPs ) with those of students receiving feedback primarily from faculty . METHOD : All 154 first-year students at the University of Oklahoma College of Medicine in 1993 - 94 were video-taped to assess baseline and post-instruction interviewing skills . All the students , r and omized to one of three study groups , attended two four-hour workshops on interviewing skills . Instruction in the groups was as similar as possible except in the matter of who provided feedback . Two rating systems were used to rate the videotaped interviews for performances of targeted skills . RESULTS : Complete , usable data were available for 120 ( 78 % ) of the students . Skill ratings using the Arizona Clinical Interview Rating Scale were significantly higher for the “ types of questions used ” and “ use of empathy ” items in the SP-led feedback group . No significant difference in ratings was detected among the groups as measured by the Rotor Interactional Analysis System . CONCLUSION : The SPs were at least as effective as the faculty in effecting behavioral changes in the first-year medical students ' interviewing skills
Output:
| Although feedback from the patient 's perspective is generally recommended , most SPs provided feedback on clinical skills and communication skills .
DISCUSSION There appear to be no clear st and ards with regard to effective feedback training for SPs . |
MS213963 | ***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 There is evidence from North American trials that supported employment using the individual placement and support ( IPS ) model is effective in helping individuals with severe mental illness gain competitive employment . There have been few trials in other parts of the world . Aims To investigate the effectiveness and cost-effectiveness of IPS in the UK . Method Individuals with severe mental illness in South London were r and omised to IPS or local traditional vocational services ( treatment as usual ) ( IS RCT N96677673 ) . Results Two hundred and nineteen participants were r and omised , and 90 % assessed 1 year later . There were no significant differences between the treatment as usual and intervention groups in obtaining competitive employment ( 13 % in the intervention group and 7 % in controls ; risk ratio 1.35 , 95 % CI 0.95–1.93 , P = 0.15 ) , nor in secondary outcomes . Conclusions There was no evidence that IPS was of significant benefit in achieving competitive employment for individuals in South London at 1-year follow-up , which may reflect suboptimal implementation . Implementation of IPS can be challenging in the UK context where IPS is not structurally integrated with mental health services , and economic disincentives may lead to lower levels of motivation in individuals with severe mental illness and psychiatric professionals BACKGROUND An international six-centre r and omised controlled trial comparing individual placement and support ( IPS ) with usual vocational rehabilitation for people with serious mental illness found IPS to be more effective for all vocational outcomes . AIMS To determine which patients with severe mental illness do well in vocational services and which process and service factors are associated with better outcomes . METHOD Patient characteristics and early process variables were tested as predictors of employment outcomes . Service characteristics were explored as predictors of the effectiveness of IPS . RESULTS Patients with previous work history , fewer met social needs and better relationships with their vocational workers were more likely to obtain employment and work for longer . Remission and swifter service uptake were associated with working more . Having an IPS service closer to the original IPS model was the only service characteristic associated with greater effectiveness . CONCLUSIONS The IPS service was found to be more effective for all vocational outcomes . In addition , maintaining high IPS fidelity and targeting relational skills would be a valuable focus for all vocational interventions , leading to improved employment outcomes . Motivation to find work may be decreased by satisfaction with current life circumstances This report describes the results of a r and omized controlled feasibility study of the Mindfulness Intervention for Rehabilitation and Recovery in Schizophrenia ( MIRRORS ) . MIRRORS is an adaptation of Mindfulness-Based Stress Reduction design ed to help persons with schizophrenia to persist and perform better at work . Thirty-four participants with schizophrenia or schizoaffective disorder who were engaged in outpatient services were enrolled in a vocational rehabilitation program that included a job placement and then were r and omized to receive MIRRORS ( n = 18 ) or Intensive Support ( n = 16 ) over a period of 16 weeks . The number of hours worked was recorded weekly and job performance was assessed monthly using the Work Behavior Inventory . Results of t-tests revealed that participants in the MIRRORS group worked a significantly greater number of hours and performed significantly better at the end of the 4-month intervention than those in the Intensive Support condition . Repeated- measures analysis of variance revealed that the MIRRORS group worked more hours each week on average and that this difference increased over time as well as having generally better work performance compared with the Intensive Support group . Results suggest a link between MIRRORS and higher levels of work performance and persistence in people with schizophrenia . Further research is indicated to evaluate MIRRORS in a fully powered r and omized controlled trial OBJECTIVE This purpose of this study was to determine whether participation in the Work-Ordered Day program of the Clubhouse model has a positive effect on vocational outcomes . METHOD The longitudinal study followed a group of individuals with severe mental illness who were r and omly assigned either to a Clubhouse program or a Program of Assertive Community Treatment team . Study participants were tracked for 135 weeks . These analyses evaluated the relationship between Work-Ordered Day participation and employment duration for the 43 study participants enrolled in the Clubhouse program who were active throughout the study and competitively employed during the study . RESULTS Participation in the Work-Ordered Day program had a significant positive impact on average duration of employment . On average , a 1-hr increase in participation prior to employment led to an increase of 2.3 weeks in competitive employment . CONCLUSIONS AND IMPLICATION S FOR PRACTICE Participants with more Work-Ordered Day program participation prior to employment had significantly longer average competitive employment duration even when controlling for prior work history . Participation in the Work-Ordered Day program is likely to improve work readiness . Further research is warranted to study which elements of the program may foment employment success . This could lead to increased implementation of the Work-Ordered Day program and its elements as precursors to employment for adults with severe mental illness OBJECTIVES The present study aims to investigate the synergistic effects of cognitive remediation training ( CRT ) on Integrated Supported Employment ( ISE ) . ISE blends individual placement support service with work-related social skills training for Chinese people suffering from schizophrenia or schizoaffective disorder . METHOD Ninety participants with schizophrenia or schizoaffective disorders were recruited from two psychiatric outpatient services in Hong Kong . They were r and omly assigned into the ISE+CRT ( n=45 ) and ISE ( n=45 ) conditions . Blinded assessment s on vocational , clinical , psychological , and neurocognitive outcomes were conducted by independent assessors . The two groups were followed up at 7 and 11months . RESULTS Both groups yielded similar improvements across several outcome domains assessed immediately after the interventions and at 7 and 11month follow-ups , but no significant group differences were found . Significant positive trends over time in vocational , clinical and cognitive outcomes consistently favored the ISE+CRT condition . CONCLUSION While both the ISE+CRT and ISE groups demonstrated improvement in vocational , clinical , psychological , and neurocognitive outcomes , there was no evidence to show that cognitive remediation facilitated further improvement in these domains beyond gains associated with ISE alone . Further investigation is needed to fully exploit the synergistic potential of ISE combined with CRT , and to better underst and which individuals experience a maximal benefit from the specific rehabilitation program components OBJECTIVE Schizophrenia is a mental disorder and characterized by abnormal social behavior and failure to recognize what is real . The current study was to explore the long-term effects of cognitive rehabilitation training on schizophrenia . METHODS Eighty six cases of hospitalized patients with schizophrenia were r and omly divided into study group and control group . The relapse and employment ( attending school ) rates were used as indicators to assess the treatment effect . All patients were followed up by 2 years . Kaplan-Meier survival analysis was conducted with relapse and employment ( attending school ) rates . RESULTS The rates of relapse in the study group and the control group were 18 % and 41 % , and relapse free survival time was 22.22 months and 18.55 months ; the rates of employment ( attending school ) were 64 % and 43 % , and not employment ( attending school ) time were 10.68 months and 15.74 months , respectively . There was significant difference between the two groups ( P<0.05 ) . CONCLUSIONS We found that the cognitive rehabilitation training could significantly reduce schizophrenic relapse rate , prolong the time of patients without relapse , improve the employment ( attending school ) rate , and shorten the discharged time , which is a powerful treatment method to improve social competence in schizophrenia patients Hoffmann H , Jäckel D , Glauser S , Kupper Z. A r and omised controlled trial of the efficacy of supported employment Abstract Background Although the effectiveness of individual placement and support ( IPS ) has been well established , little is known about clients ’ perceptions of the model compared to usual vocational rehabilitation , nor about their experiences of search ing for and returning to work with this kind of support . This qualitative study aim ed to explore clients ’ views of the difficulties of obtaining and maintaining employment , their experiences of the support received from their IPS or Vocational Service workers and the perceived impact of work on clients ’ lives . MethodS emi-structured interviews were conducted with 48 people with psychotic disorders participating in a six-centre international r and omised controlled trial of IPS compared to usual vocational rehabilitation . To assess their experiences of the services and the perceived effects of working , two IPS and two Vocational Service clients at each centre who had found work during the study period were interviewed , along with two IPS and two Vocational Service clients at each centre who had not . Results IPS clients reported having received more help seeking and maintaining employment , whereas Vocational Service clients reported having received more help in finding sheltered employment or placements . Clients who had worked associated this with financial stability , improved social lives , increased self-esteem , integration into society and amelioration of their symptoms , as well as reduced feelings of boredom and isolation , but also reported increased levels of stress . IPS clients as well as Vocational Service ones reported not receiving enough follow-up support , despite this being proposed as a key feature of the model . Conclusion Findings from the in-depth interviews reflect differences in service models that have also been tested quantitatively but further work in disaggregating the IPS model and assessing the impact of each component would be valuable Several studies in schizophrenia found a positive association between cognitive performance and work status , and it has been reported that good cognitive performance at the outset does predict the success of vocational interventions . However little has been done to investigate whether vocational interventions itself benefit cognitive performance . To test this hypothesis we performed a r and omized , placebo-controlled trial to investigate in remitted schizophrenic patients the effect of a 6-months vocational rehabilitation program on cognitive performance . We recruited 112 remitted and clinical ly stable schizophrenic patients who aim ed to enter a vocational rehabilitation program . From these , 57 immediately entered a 6-months vocational rehabilitation program , whereas the remaining 55 were allocated to a waiting-list ; the latter formed our control group , which received during the 6 months out-clinic follow-up treatment . Before and after the 6-months period we assessed changes in cognitive performance through a neuropsychological test battery , as well as changes in the psychopathological status and in quality of life . We found that vocational rehabilitation significantly improved patients ' performance in cognitive measures that assess executive functions ( concept formation , shifting ability , flexibility , inhibitory control , and judgment and critics abilities ) . Moreover , after 6 months the vocational group improved significantly in the negative symptoms and in quality of life , as compared to controls . Together with results from the literature , our findings reinforce the notion that the inclusion of vocational interventions may enhance the effectiveness of therapeutic strategies for schizophrenia patients BACKGROUND Concerns are frequently expressed that working might worsen the mental health of people with severe mental illness ( SMI ) . Several studies of Individual Placement and Support ( IPS ) , however , have found associations between working and better nonvocational outcomes . IPS has been found to double the return to work of people with SMI in 6 European countries . AIMS To explore separately associations between IPS , returning to work , and clinical and social outcomes . METHODS Patients ( n = 312 ) in a r and omized controlled trial of IPS in 6 European centers were followed up for 18 months . RESULTS There were no differences in clinical and social functioning between IPS and control patients at 18 months . Those who worked had better global functioning , fewer symptoms , and less social disability at final follow-up ; greater job tenure was associated with better functioning . Working was associated with concurrently better clinical and social functioning , but this contrast was stronger in the control group , suggesting that IPS was better than the control service at helping more unwell patients into work . Working was associated with having been in remission and out of hospital for the previous 6 months . It was also associated with a slight decrease in depression and with being in remission over the subsequent 6 months . CONCLUSIONS Concerns among clinicians about possible detrimental effects of working and supported employment have been misplaced . Although some of the associations found may have been selection effects , there is sufficient evidence of work having beneficial effects on clinical and social functioning to merit further exploration OBJECTIVE Despite the large number of Latinos living in the United States , little research has evaluated the effectiveness of different vocational rehabilitation programs for individuals with severe mental illness in this rapidly growing minority population . This article presents a secondary analysis of a r and omized , controlled trial comparing supported employment with 2 other vocational rehabilitation programs in 3 ethnic/racial groups of participants with severe mental illness : Latinos , non-Latino African Americans , and non-Latino Whites . METHOD The data were drawn from a previously published r and omized , controlled trial comparing supported employment with st and ard vocational rehabilitation services and a psychosocial clubhouse program in persons with severe mental illness ( Mueser et al. , 2004 ) , including 64 Latinos , 91 non-Latino African Americans , and 43 non-Latino Whites . Comparisons were made between the 3 groups at baseline on demographic characteristics , clinical and psychosocial functioning , and quality of life . Within each ethnic/racial group , competitive employment and all paid employment outcomes were compared between the 3 vocational rehabilitation programs over the 2-year study period . RESULTS At baseline , the Latino participants had lower levels of education and disability income , were less likely to have worked competitively over the previous 5 years , had more severe symptoms , and worse psychosocial functioning than the non-Latino African American or non-Latino White participants . Latinos r and omized to supported employment had better competitive and all-paid work outcomes than those assigned to either st and ard services or the
Output:
| For employment , strong evidence was found for the Individual Placement and Support ( IPS ) model and cognitive interventions .
For education , moderate evidence was found for supported education interventions .
This systematic review supports the role of occupational therapy practitioners in promoting the implementation of IPS , cognitive‐based , and social skills programs to improve vocational and educational outcomes for adults with SMI .
& NA ; Evidence supports the role of occupational therapy practitioners in promoting the implementation of IPS , cognitive‐based , and social skills programs to improve vocational and educational outcomes for adults with SMI |
MS213964 | ***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 . There is controversy regarding whether hypersensitivity to food proteins contributes to colic among breastfed infants . Methods . A r and omized , controlled trial of a low-allergen maternal diet was conducted among exclusively breastfed infants presenting with colic . In the active arm , mothers excluded cow 's milk , eggs , peanuts , tree nuts , wheat , soy , and fish from their diet ; mothers in the control group continued to consume these foods . Outcomes were assessed after 7 days , as the change in cry/fuss duration over 48 hours , with vali date d charts . The primary end point was a reduction in cry/fuss duration of ≥25 % from baseline . Mothers also assessed the responses to diet with categorical and visual analog scales . Results . Of 107 infants , 90 completed the trial ( mean age : 5.7 weeks ; range : 2.9–8.6 weeks ; 54 male infants ) . Infants in both groups presented with significant distress ( geometric mean : low-allergen group : 690 minutes per 48 hours ; control group : 631 minutes per 48 hours ) . In follow-up assessment s on days 8 and 9 , there were significantly more responders in the low-allergen group ( 74 % vs 37 % ) , ie , an absolute risk reduction of 37 % ( 95 % confidence interval : 18–56 % ) . Cry/fuss duration per 48 hours was reduced by a substantially greater amount in the low-allergen group ; the adjusted geometric mean ratio was 0.79 ( 95 % confidence interval : 0.63–0.97 ) , ie , an average reduction of 21 % ( 95 % confidence interval : 3–37 % ) . Mothers ' subjective assessment s of the responses to diet indicated little difference between the groups . Conclusion . Exclusion of allergenic foods from the maternal diet was associated with a reduction in distressed behavior among breastfed infants with colic presenting in the first 6 weeks of life OBJECTIVE To determine the effect of brief early exposure to cows ’ milk on atopy in the first 2 years of life . DESIGN Double blind , placebo controlled , r and omised feeding intervention trial ( Bokaal study ) . SETTING Dutch midwifery practice s. PARTICIPANTS 1533 breast fed neonates . INTERVENTION Exposure to cows ’ milk protein ( n = 758 ) or a protein free placebo ( n = 775 ) during the first 3 days of life . MAIN OUTCOME MEASURES Clinical atopic disease and any positive radioallergosorbent ( RAST ) tests at 1 year of age . RESULTS Atopic disease in the first year was found in 10.0 % ( cows ’ milk)v 9.3 % ( placebo ) of the children , with a relative risk of 1.07 ; in the second year , atopic disease was found in 9.6 % v 10.2 % , respectively , with a relative risk of 0.94 . Per protocol analysis showed similar results . Any RAST positive test was found in 9.4 % ( cows ’ milk)v 7.9 % ( placebo ) of children , with a relative risk of 1.19 . Stratified analysis for high family risk of allergy showed a doubled incidence of atopic disease but no effect from the intervention . CONCLUSION Early and brief exposure to cows ’ milk in breast fed children does not increase the risk of atopic disease in the first 2 years Background : Little is known about the diagnostic accuracy of atopy patch tests ( APT ) in the clinical practice of pediatric gastroenterology . Moreover , APTs containing purified food extracts have recently become available , but their diagnostic accuracy is largely undefined Thirty seven breast fed infants with eczema were studied to see whether changes in their mothers ' diets affected their skin condition . Nineteen mothers and babies took part in a double blind crossover trial of exclusion of egg and cows ' milk , and 18 took part in open exclusion of 11 foods followed by double blind challenge to those mothers whose infants seemed to respond . Babies were examined at the beginning and end of each dietary period , and the extent and severity of the rash were given a numerical score . The eczema improved in six infants when their mothers avoided egg and cows ' milk and worsened again when these were reintroduced . Two infants suffered gastrointestinal reactions after maternal ingestion of egg and cows ' milk , one developing colitis . Maternal dietary exclusion seems to benefit some breast fed babies with eczema A mixture of neutral short-chain galactooligosaccharides ( scGOS ) and long-chain fructooligosaccharides ( lcFOS ) has been shown to reduce the incidence of atopic dermatitis ( AD ) and infectious episodes during the first 6 mo of life . This dual protection occurred through the intervention period . The present study evaluated if these protective effects were lasting beyond the intervention period . In a prospect i ve , r and omized , double-blind , placebo-controlled design , healthy term infants with a parental history of atopy were fed either a prebiotic-supplemented ( 8 g/L scGOS/lcFOS ) or placebo-supplemented ( 8 g/L maltodextrin ) hypoallergenic formula during the first 6 mo of life . Following this intervention period , blind follow-up continued until 2 y of life . Primary endpoints were cumulative incidence of allergic manifestations . Secondary endpoints were number of infectious episodes and growth . Of 152 participants , 134 infants ( 68 in placebo , 66 in intervention group ) completed the follow-up . During this period , infants in the scGOS/lcFOS group had significantly lower incidence of allergic manifestations . Cumulative incidences for AD , recurrent wheezing , and allergic urticaria were higher in the placebo group , ( 27.9 , 20.6 , and 10.3 % , respectively ) than in the intervention group ( 13.6 , 7.6 , and 1.5 % ) ( P < 0.05 ) . Infants in the scGOS/lcFOS group had fewer episodes of physician-diagnosed overall and upper respiratory tract infections ( P < 0.01 ) , fever episodes ( P < 0.00001 ) , and fewer antibiotic prescriptions ( P < 0.05 ) . Growth was normal and similar in both groups . Early dietary intervention with oligosaccharide prebiotics has a protective effect against both allergic manifestations and infections . The observed dual protection lasting beyond the intervention period suggests that an immune modulating effect through the intestinal flora modification may be the principal mechanism of action BACKGROUND Early feeding with cow 's milk ( CM ) may increase the risk of cow 's milk allergy ( CMA ) . OBJECTIVE We sought to examine prospect ively whether supplementary feeding of CM at the maternity hospital would increase the risk when compared with feeding with pasteurized human milk or hydrolyzed formula . METHODS We studied 6209 unselected healthy , full-term infants , of whom 5385 ( 87 % ) required supplementary milk while in the hospital . The infants were r and omly assigned to receive CM formula ( 1789 infants ) , pasteurized human milk ( 1859 infants ) , or whey hydrolysate formula ( 1737 infants ) . The comparison group ( 824 infants ) was composed of infants who were exclusively breast-fed . The infants were followed for 18 to 34 months for symptoms suggestive of CMA . The primary endpoint was a challenge-proven adverse reaction to CM after a successful CM elimination diet . RESULTS The cumulative incidence of CMA in the infants fed CM was 2.4 % compared with 1.7 % in the pasteurized human milk group ( odds ratio [ OR ] , 0.70 ; 95 % confidence interval [ CI ] , 0 . 44 - 1.12 ) and 1.5 % in the whey hydrolysate group ( OR , 0.61 ; 95 % CI , 0 . 38 - 1.00 ) . In the comparison group , CMA developed in 2.1 % of the infants . Among the infants who required supplementary feeding at hospital , both exposure to CM while in the hospital ( OR , 1.54 ; 95 % CI , 1.04 - 2.30 ; P = .03 ) and obvious parental atopy ( OR , 2.32 ; 95 % CI , 1.53 - 3.52 ; P < .001 ) increased the risk of CMA . CONCLUSIONS Our data indicate that feeding of CM at maternity hospitals increases the risk of CMA when compared with feeding of other supplements , but exclusive breast-feeding does not eliminate the risk The aim of this study was to assess the preventive effect of exclusive breast-feeding and early solid food avoidance on atopic dermatitis ( AD ) in infancy . This study is part of a dietary clinical trial in a prospect i ve cohort of healthy term newborns at risk of atopy . It was recommended to breast-feed for at least 4 months and to avoid solid food in the same time-period . Eight hundred and sixty-five infants exclusively breast-fed , and 256 infants partially or exclusively formula-fed , were followed-up until the end of the first year following birth . AD and sensitization to milk and egg were considered as study end-points . The 1-year incidence of AD was compared between the two study groups . Adjusted odds ratios ( OR ) with 95 % confidence intervals ( CI ) were calculated by multiple logistic regression . The incidence of AD was calculated in relation to age at introduction of solid food and amount of food given . In the breast-fed group , the adjusted OR for AD was 0.47 ( 95 % CI 0.30 - 0.74 ) . The strongest risk factor was the occurrence of AD in the subject 's core family . The risk of infants with AD to be sensitized to milk was four times higher , and to egg eight times higher , than in infants without AD . Age at first introduction of solid food and diversity of solid food showed no effect on AD incidence . We conclude that in infants at atopic risk , exclusive breast-feeding for at least 4 months is effective in preventing AD in the first year of life BACKGROUND Recommendations for primary prevention of allergic diseases in high-risk children include feeding with hydrolyzed formulas if breast-feeding is insufficient . OBJECTIVE The primary objective of the German Infant Nutritional Intervention study was to investigate the allergy preventive effect of 3 hydrolyzed formulas compared with cow 's milk formula in the first 3 years of life in a r and omized , double-blind trial . METHODS Between 1995 and 1998 , 2252 newborns with atopic heredity were allocated to a group receiving cow 's milk formula , partially or extensively hydrolyzed whey formula , or extensively hydrolyzed casein formula as a milk substitute for the first 4 months if breast-feeding was insufficient . Main outcome parameters were allergic manifestations , atopic dermatitis ( AD ) , and asthma . RESULTS After 3 years , 396 of 2252 children ( 17.6 % ) had dropped out . Breast-fed infants without formula feeding during the intervention ( n = 889 ) were considered separately . A significant reduction of the incidence of AD was achieved with the extensively hydrolyzed casein formula in the intention-to-treat ( ITT ; n = 1363 ) and per protocol ( PP ; n = 904 ) analyses ( ITT : population odds ratio [ 95 % CI ] , 0.67 [ 0.45 - 0.99 ] ; PP : adjusted odds ratio [ OR(adj ) ] , 0.53 [ 0.32 - 0.88 ] ) , and with the partially hydrolyzed whey formula in the PP analysis ( ITT : population odds ratio , 0.76 [ 0.52 - 1.11 ] ; PP : OR(adj ) , 0.60 [ 0.37 - 0.97 ] ) . None of the formulas reduced the incidence of asthma . CONCLUSION The risk for AD , but not for asthma , can be reduced with certain cow 's milk hydrolyzates in high-risk infants when breast-feeding is insufficient . CLINICAL IMPLICATION S Early nutritional intervention in high-risk children has significant influence on the incidence of AD , but not of asthma A recent increase in the prevalence of atopic disorders and the enormous costs of management of atopic patients have prompted attempts at prevention . We have examined the effect of exclusive breast feeding and of feeding different infant formulas on incidence of atopic disease in a prospect i ve r and omized controlled study . Seventy-two infants were recruited into each of the following groups : cow milk whey hydrolysate formula ( NAN/HA ) conventional cow milk formula ( Similac ) , soy-based formula ( Isomil ) , and exclusive breast feeding for greater than 4 months . The cumulative incidence of atopic eczema , recurrent wheezing , rhinitis , gastrointestinal symptoms , and colic were noted . Skin prick tests and radioallergosorbent tests for IgE antibodies to milk and soy were performed . At 12 and 18 months of age , the incidence of atopic eczema as also that of all atopic symptoms was significantly lower and similar in the breast-fed and whey hydrolysate groups , compared with the cow milk and soy formula groups . IgE antibodies were detected more often in the cow milk and soy formula groups , especially the former . Among symptomatic infants , fewer skin positive prick tests were seen in the soy group compared with the cow milk group . Our observations show that
Output:
| It is unclear if the prevalence of food allergies is increasing .
In high-risk infants , hydrolyzed formulas may prevent cow 's milk allergy but st and ardized definitions of high risk and hydrolyzed formula do not exist .
The evidence for the prevalence and management of food allergy is greatly limited by a lack of uniformity for criteria for making a diagnosis |
MS213965 | ***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 Elevated temperature worsens injury in experimental focal and global ischemia and brain trauma . Fever is common in patients with acute neurologic illness and independently predicts poor outcome . Conventional means of treating fever are not very effective in this population . Objective To study the effectiveness of a catheter-based heat exchange system in reducing elevated temperatures in critically ill neurologic and neurosurgical patients . Design , Intervention , Setting , and Population This was a prospect i ve r and omized , nonblinded trial that compared conventional treatment of fever ( acetaminophen and cooling blankets ) with conventional treatment plus an intravascular catheter-based heat exchange system ( Alsius , Irvine , CA ) . Patients admitted to one of 13 neurologic intensive care units in academic medical centers were eligible if they a ) suffered subarachnoid hemorrhage , intracerebral hemorrhage , ischemic infa rct ion , or traumatic brain injury ; b ) had a temperature > 38 ° C on two occasions or for > 4 continuous hrs ; and c ) required central venous access . Main Outcome MeasureThe fever burden ( area under the curve > 38 ° C ) for 72 hrs was compared in an intention to treat analysis . Safety of the catheter system was monitored . Results A total of 296 patients were enrolled over 20 months . Forty-one percent had subarachnoid hemorrhage , 24 % had traumatic brain injury , 23 % had intracerebral hemorrhage , and 13 % had ischemic stroke . The groups were matched in terms of age , body mass index , sex , and Glasgow Coma Scale score distribution . Fever burden was 7.92 vs. 2.87 ° C-hrs in the conventional group and catheter groups , respectively ( 64 % reduction , p < .01 ) . There was no higher rate of infection or the use of sedatives , narcotics , or antibiotics in the catheter group . The catheter did not significantly increase risk to the patient beyond that of a central catheter . Conclusions The addition of this catheter-based cooling system to conventional management significantly improves fever reduction in neurologic intensive care unit patients BACKGROUND Pyrexia is common after brain injury ; it is generally believed to affect outcome adversely and the usual clinical methods of reducing temperature are not effective . The normal physiological mechanisms of brain cooling are heat loss from the upper airways and through the skull , and these can produce selective brain cooling . METHODS Air at room temperature and humidity was continuously administered to 15 brain-injured , intubated and mechanically ventilated patients via a sponge-tipped oxygen catheter in each nostril at a combined rate of 115 ml kg(-1 ) min(-1 ) . Brain temperature was measured using a pressure-temperature Camino catheter which is design ed to site the thermistor 1 cm into the parenchyma in the frontal lobe . Oesophageal temperature was measured using an oesophageal stethoscope with a thermistor . After establishing baseline for 30 min , patients were r and omized to receive airflow or no airflow for 6 h and then crossed over for a further 6 h. RESULTS Airflow replicating normal resting minute volume did not produce clinical ly relevant or statistically significant reductions in brain temperature [ 0.13 ( SD 0.55 ) degrees C ; 95 % CI , 0.43 - 0.17 degrees C ] . However , we serendipitously found some evidence of selective brain cooling via the skull , but this needs further substantiation . CONCLUSIONS A flow of humidified air at room temperature through the upper respiratory tracts of intubated brain-injured patients did not produce clinical ly relevant or statistically significant reductions in brain temperature measured in the frontal lobe Background Temperature management is used with increased frequency as a tool to mitigate neurological injury . Although frequently used , little is known about the optimal cooling methods for inducing and maintaining controlled normo- and hypothermia in the intensive care unit ( ICU ) . In this study we compared the efficacy of several commercially available cooling devices for temperature management in ICU patients with various types of neurological injury . Methods Fifty adult ICU patients with an indication for controlled mild hypothermia or strict normothermia were prospect ively enrolled . Ten patients in each group were assigned in consecutive order to conventional cooling ( that is , rapid infusion of 30 ml/kg cold fluids , ice and /or coldpacks ) , cooling with water circulating blankets , air circulating blankets , water circulating gel-coated pads and an intravascular heat exchange system . In all patients the speed of cooling ( expressed as ° C/h ) was measured . After the target temperature was reached , we measured the percentage of time the patient 's temperature was 0.2 ° C below or above the target range . Rates of temperature decline over time were analyzed with one-way analysis of variance . Differences between groups were analyzed with one-way analysis of variance , with Bonferroni correction for multiple comparisons . A p < 0.05 was considered statistically significant . Results Temperature decline was significantly higher with the water-circulating blankets ( 1.33 ± 0.63 ° C/h ) , gel-pads ( 1.04 ± 0.14 ° C/h ) and intravascular cooling ( 1.46 ± 0.42 ° C/h ) compared to conventional cooling ( 0.31 ± 0.23 ° C/h ) and the air-circulating blankets ( 0.18 ± 0.2 ° C/h ) ( p < 0.01 ) . After the target temperature was reached , the intravascular cooling device was 11.2 ± 18.7 % of the time out of range , which was significantly less compared to all other methods . Conclusion Cooling with water-circulating blankets , gel-pads and intravascular cooling is more efficient compared to conventional cooling and air-circulating blankets . The intravascular cooling system is most reliable to maintain a stable temperature OBJECT Hypothermia is by far the most potent neuroprotectant . Nevertheless , timely and safe delivery of hypothermia remains a clinical challenge . To maximize neuroprotection yet minimize systemic complications , ultra-early delivery of selective cerebral hypothermia by Emergency Medical Service ( EMS ) personnel in the field would be advantageous . The authors ( W.E. and H.W. ) have developed a cooling helmet by using National Aeronautics and Space Administration spinoff technology . In this study its effectiveness in lowering brain temperature in patients with severe stroke or head injury is examined . METHODS Patients were r and omly assigned to groups receiving either the cooling helmet or no cooling , and brain temperatures ( 0.8 cm below the cortical surface ) were continuously monitored for a mean of 48 to 72 hours with a Neurotrend sensor and then compared with the patients ' core temperatures . There were eight patients in the study group and six in the control group . The mean change in temperature ( brain-body temperature ) calculated from 277 data hours in the study group was -1.6 degrees C compared with a mean change in temperature of + 0.22 degrees C calculated from 309 data hours in the control group . This was statistically significant ( p < 0.0001 ) . On average , 1.84 degrees C of brain temperature reduction ( range 0.9 - 2.4 degrees C ) was observed within 1 hour of helmet application . It took a mean of 3.4 hours ( range 2 - 6 hours ) to achieve a brain temperature lower than 34 degrees C and 6.67 hours ( range 1 - 12 hours ) before systemic hypothermia ( < 36 degrees C ) occurred . Use of the helmet result ed in no significant complications . There was , however , one episode of asymptomatic bradycardia ( heart rate < 40 ) that responded to a 0.5 degrees C body temperature increase . CONCLUSIONS This helmet delivers initial rapid and selective brain cooling and maintains a significant temperature gradient between the core and brain temperatures throughout the hypothermic period to provide sufficient regional hypothermia yet minimize systemic complications . It results in delayed systemic hypothermia , creating a safe window for possible ultra-early delivery of regional hypothermia by EMS personnel in the field BACKGROUND Cerebral hypothermia can improve outcome of experimental perinatal hypoxia-ischaemia . We did a multicentre r and omised controlled trial to find out if delayed head cooling can improve neurodevelopmental outcome in babies with neonatal encephalopathy . METHODS 234 term infants with moderate to severe neonatal encephalopathy and abnormal amplitude integrated electroencephalography ( aEEG ) were r and omly assigned to either head cooling for 72 h , within 6 h of birth , with rectal temperature maintained at 34 - 35 degrees C ( n=116 ) , or conventional care ( n=118 ) . Primary outcome was death or severe disability at 18 months . Analysis was by intention to treat . We examined in two predefined subgroup analyses the effect of hypothermia in babies with the most severe aEEG changes before r and omisation -- ie , severe loss of background amplitude , and seizures-- and those with less severe changes . FINDINGS In 16 babies , follow-up data were not available . Thus in 218 infants ( 93 % ) , 73/110 ( 66 % ) allocated conventional care and 59/108 ( 55 % ) assigned head cooling died or had severe disability at 18 months ( odds ratio 0.61 ; 95 % CI 0.34 - 1.09 , p=0.1 ) . After adjustment for the severity of aEEG changes with a logistic regression model , the odds ratio for hypothermia treatment was 0.57 ( 0.32 - 1.01 , p=0.05 ) . No difference was noted in the frequency of clinical ly important complications . Predefined subgroup analysis suggested that head cooling had no effect in infants with the most severe aEEG changes ( n=46 , 1.8 ; 0.49 - 6.4 , p=0.51 ) , but was beneficial in infants with less severe aEEG changes ( n=172 , 0.42 ; 0.22 - 0.80 , p=0.009 ) . INTERPRETATION These data suggest that although induced head cooling is not protective in a mixed population of infants with neonatal encephalopathy , it could safely improve survival without severe neurodevelopmental disability in infants with less severe aEEG changes Introduction Aim of this r and omized prospect i ve clinical trial is to compare two methods of antipyretics and evaluate their efficacy in controlling fever during the acute phase of brain damage . Methods Twenty-two febrile comatose patients : 12 severe traumatic brain injury and 10 subarachnoid hemorrhage divided in 2 groups : Diclofenac low-dose infusion ( 10 patients ) and extemporaneous boluses of NSAIDs ( CTRL , 12 patients ) . The primary outcome measure was length of time with temperature > 38 ° C . Secondary outcome measures were : 1 ) to assess the effects of each antipyretic strategy on intracranial pressure ( ICP ) , cerebral perfusion pressure ( CPP ) , mean arterial pressure ( MAP ) and heart rate ; 2 ) to monitor adverse effects of each antipyretic strategy . The baseline characteristics in the two treatment groups were similar . Results Primary findings : percentage of time per patient with temperature > 38 ° C was significantly lower ( P < 0.0001 ) in the DCF group , 4 % ( 0–22 % ) , vs. 34 % ( 8–56 % ) in CTRL group . In addition , mean T ° , max T ° were lower in DCF than in CTRL ( P < 0.05 ) . Secondary findings : CPP and MAP were significantly higher in DCF group ( P < 0.05 ) while ICP was not different ( NS ) . However , if ICP pre r and omization was < 25 mmHg , CTRL suffered a worst ICP ( 24 ± 11 vs. 16 ± 7 P = 0.01 ) , MAP ( 89 ± 10 vs. 104 ± 10 P = 0.01 ) and CPP ( 75 ± 10 vs. 94 ± 17 P = 0.01 ) compared to DCF . No differences between the two treatment were recorded when ICP ≥ 25 mmHg before r and omization . There was no gastrointestinal or intracranial bleeding . Conclusions Low dose DCF infusion is a potential useful strategy for a successful control temperature better than intermittent NSAIDs dosing , minimizing potentially brain-damaging effects of fever BACKGROUND Heat loss from the upper airways and through the skull are physiological mechanisms of brain cooling which have not been fully explored clinical ly . METHODS This r and omized , crossover , factorial trial in 12 brain-injured , orally intubated patients investigated the effect of enhanced nasal airflow ( high flow unhumidified air with 20 p.p.m . nitric oxide gas ) and bilateral head fanning on frontal lobe brain temperature and selective brain cooling . After a 30 min baseline , each patient received the four possible combinations of the interventions --airflow , fanning , both together , no intervention -- in r and omized order . Each combination was delivered for 30 min and followed by a 30 min washout , the last 5 min of which provided the baseline for the next intervention . RESULTS The difference in mean brain temperature over the last 5 min of the preceding washout minus the mean over the last 5 min of intervention , was 0.15 degrees C with nasal airflow ( P=0.001 , 95 % CI 0.06 - 0.23 degrees C ) and
Output:
| There is no evidence that interventions aim ed at reducing body temperature to between 35 degrees C and 37.5 degrees C in the first week after TBI improves patient outcomes . |
MS213966 | ***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: Several types of air turbine scalers have recently been introduced as an alternative to ultrasonic equipment in periodontal therapy . The aim of this investigation was to compare clinical , periodontal healing after scaling with the Titan S air turbine scaler and h and instruments . Twelve patients referred to the School of Dental Hygiene , Jönköping , Sweden , for treatment of moderately advanced periodontitis participated in the study . After examination , diagnosis , treatment planning , and information , the teeth of the left and right quadrants were r and omly assigned to Titan S or h and instruments scaling ( " split mouth design ") . The treatment was given by 6 dental hygiene students . Final re-examination was performed 3 months after instrumentation . After treatment , a marked improvement of periodontal conditions , expressed as number of tooth surfaces with plaque , number of sites with probing pocket depth greater than or equal to 4 mm and percentage of sites showing bleeding on probing to the bottom of the pocket , was obtained . No difference in results was observed when comparing Titan S and h and instrumentation . The time required for instrumentation was , however , shorter for Titan S than for h and instruments . Based on the results of this study , it may be concluded that , in patients with moderately advanced periodontitis , periodontal healing after scaling with the Titan S and h and instruments is comparable Several studies have found incomplete calculus removal during periodontal treatment with traditional h and curets , sonic , and ultrasonic instruments . This study evaluated the speed and effectiveness of subgingival calculus removal with new diamond-coated ultrasonic tips on single-rooted teeth . Single session subgingival scaling and root planing was performed on 80 teeth with 5 to 12 mm probing depths in 15 patients . Each patient provided groups of 4 teeth that were r and omly treated with either h and curets ( H AND ) ; st and ard smooth ultrasonic tip ( US ) ; or fine grit ( FINDIAM ) or medium grit ( MEDDIAM ) diamond-coated ultrasonic tips . The time taken to reach the therapeutic endpoint of a clean , smooth root surface in a defined region on each tooth with each instrument by the 3 therapists with differing experience levels was recorded . The teeth were then atraumatically extracted , stored in a surfactant , photographed at 10X , and the percent of calculus present in the area of the pocket or on a comparable control surface calculated by histometric point counting . ANOVA and paired t tests showed that mean percent remaining calculus on treated versus control surfaces was H AND 4.6 + /- 5.3 versus 57.5 + /- 28.2 , US 4.7 + /- 6.4 versus 54.4 + /- 25.9 , FINDIAM 4.3 + /- 5.2 versus 37.5 + /- 22.1 , and MEDDIAM 3.4 + /- 4.2 versus 50.7 + /- 20.1 , respectively ( all P < 0.01 ) . The mean time in seconds to reach the clinical endpoint ranged from H AND 289 + /- 193 , US 194 + /- 67 , FINDIAM 167 + /- 71 , to MEDDIAM 147 + /- 92 . All powered instruments were significantly faster than H AND ( P < 0.05 ) , but did not differ from each other . On a 0 = " smooth " to 3 = " rough " scale , most often H AND result ed in " smooth " surfaces ( 10/20 ) , the powered tips of all types " slight " surface roughness ( 10/20 each ) , and US the most " moderate " roughness ( 7/20 ) . There were no differences in percent calculus remaining , surface roughness , or time spent among the 3 treating clinicians despite their varying experience levels . The results of this study showed that percent calculus remaining was < 5 % with all the instruments given time ad libitum on a given root surface . Root roughness was generally slightly greater with all 3 powered tips . All of the powered instruments took significantly less time than the H AND . Both DIAM tips took less time than US . Diamond-coated ultrasonic tips appeared to be much more efficient than H AND or US in removing calculus in moderate-deep probing depths on single-rooted teeth in vivo As practitioners strive to improve the delivery of patient care , it is increasingly important that they find it easier to identify studies with the highest level of evidence . Once found , there must be some assurance that the studies were carried out satisfactorily and the methodology was sound . To assist in meeting this challenge , the Consoli date d St and ards of Reporting Trials ( CONSORT ) guidelines were developed by a team of dedicated journal editors , epidemiologists , and statisticians . They determined the st and ards for authors reporting the findings of controlled clinical trials . CONSORT comprises a checklist and a flow diagram ( Figs 1 and 2 ) to help improve the quality of reports of r and omized controlled trials ( RCTs ) . It offers a st and ard way for research ers to report their findings . The checklist includes items , based on evidence , that should be addressed in the report ; the flow diagram gives readers a clear picture of the progress of all participants in the trial , from the time they are r and omized until the end of their involvement . The intent is to make the experimental process transparent , flawed or not , so that users of the data can more appropriately evaluate the validity for their purpose s. The key elements start when the research er su bmi ts an article for review and completes the st and ardized forms . The completed checklist should accompany the manuscript through the review process and identify the page on which each item is addressed . The completed flow diagram should appear as a figure in the manuscript . Nearly a year ago , the AJO-DO m and ated a structured abstract with each su bmi ssion ; this is one of the first items on the CONSORT checklist . There are good reasons for this change and for all other requests listed . According to Sharma and Harrison , “ the quality of information provided in journals with structured abstract s is greater than in those with nonstructured abstract s. ” These authors concluded that the quality of information in an abstract improves when a journal changes to a structured format . AIM The aim of this study was to evaluate in vivo the effectiveness of scaling and root planing of a power-driven mechanism compared with h and instruments and ultrasonic insert alone with a split-mouth design after 3 and 6 months . METHODS Healing events after initial periodontal therapy were investigated in 20 patients with moderate-to-severe adult periodontitis . Plaque index ( PlI ) , bleeding on probing ( PBI ) , probing pocket depth ( PPD ) , probing attachment level ( PAL ) and number of moderate and deep pockets ( NMP , NDP ) were recorded at baseline and 3 and 6 months after treatment . Oral hygiene instruction was provided for each patient . R and omly assigned quadrants per patient were scaled and root planed with h and instrumentation ( curettes , hoes and files ) , with reciprocating power-driven instruments , with ultrasonic scaler alone and with the combined use of ultrasonic scaler and power-driven inserts . The Friedman test was applied to test the significance of difference between the various methods of root instrumentation . Repeated measures of analysis of variance ( manova ) were used to analyse the time effect on the different treatments . RESULTS At the 6-month evaluation , all groups in the scaling and root planing treatment presented with an improvement in the measured clinical parameters , as compared with baseline . No statistical differences ( p>0.05 ) were observed in the assessed periodontal indices among the study sites between the four groups for either treatment . CONCLUSIONS Under our experimental conditions , this clinical study demonstrates that mechanized root planing with power-driven instruments , as effective as the usual procedures ( h and and sonic instruments ) , represents a satisfactory and alternative means of nonsurgical root therapy
Output:
| The use of a letter grade scale allowed an objective analysis of the quality of evidence .
A checklist-driven model that assesses and applies evidence to dental practice may substantially improve dentists ' decision making skill |
MS213967 | ***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 : Due to high rates of undiagnosed and untreated HIV infection in Africa , we compared HIV counseling and testing ( VCT ) uptake among household members of patients receiving antiretroviral therapy . Methods : HIV-infected persons attending an AIDS clinic were r and omized to a home-based or clinic-based antiretroviral therapy program including VCT for household members . Clinic arm participants were given free VCT vouchers and encouraged to invite their household members to the clinic for VCT . Home arm participants were visited , and their household members offered VCT using a 3-test rapid finger-stick testing algorithm . VCT uptake and HIV prevalence were compared . Findings : Of 7184 household members , 3974 ( 55.3 % ) were female and 4798 ( 66.8 % ) were in the home arm . Home arm household members were more likely to receive VCT than those from the clinic arm ( 55.8 % vs. 10.9 % , odds ratio : 10.41 , 95 % confidence interval : 7.89 to 13.73 ; P < 0.001 ) , although the proportion of HIV-infected household members was higher in the clinic arm ( 17.3 % vs. 7.1 % , odds ratio : 2.76 , 95 % confidence interval : 1.97 to 3.86 , P < 0.001 ) . HIV prevalence among all household members tested in the home arm was 56 % compared with 27 % in the clinic arm . Of 148 spouses of HIV-infected patients , 69 ( 46.6 % ) were uninfected . Persons aged 15 - 24 were less likely to test than other age groups , and in the home arm , women were more likely to test than men . Conclusions : Home-based VCT for household members of HIV-infected persons was feasible , associated with lower prevalence , higher uptake , and increased identification of HIV-infected persons than clinic-based provision OBJECTIVE Patient satisfaction with HIV screening is crucial for sustainable implementation of the Centers for Disease Control and Prevention ( CDC ) HIV testing recommendations . This investigation assesses patient satisfaction with rapid HIV testing in the emergency department ( ED ) of an urban tertiary academic medical center . METHODS After receiving HIV test results , participants in the Universal Screening for HIV Infection in the Emergency Room ( USHER ) r and omized controlled trial were offered a patient satisfaction survey . Questions concerned overall satisfaction with ED visit , time spent on primary medical problem , time spent on HIV testing , and test provider 's ability to answer HIV-related questions . Responses were reported on a 4-point Likert scale , ranging from very dissatisfied to very satisfied ( defined as optimal satisfaction ) . RESULTS Of 4,860 USHER participants , 2,025 completed testing and were offered the survey : 1,616 ( 79.8 % ) completed the survey . Overall , 1,478 ( 91.5 % ) were very satisfied . Satisfaction was less than optimal for 34.5 % ( 10 of 29 ) of participants with reactive results and for 7.5 % ( 115 of 1,542 ) with nonreactive results . The independent factors associated with less than optimal satisfaction were reactive test result , aged 60 years or older , black race , Hispanic/Latino ethnicity , and testing by ED provider instead of HIV counselor . CONCLUSION Most participants were very satisfied with the ED-based rapid HIV testing program . Identification of independent factors that correlate with patient satisfaction will help guide best practice s as EDs implement CDC recommendations . It is critical to better underst and whether patients with reactive results were negatively affected by their results or truly had concerns about the testing process Background Routine HIV screening in emergency department ( ED ) setting s may require dedicated personnel . We evaluated the outcomes , costs and cost-effectiveness of HIV screening when offered by either a member of the ED staff or by an HIV counselor . Methods We employed a mathematical model to extend data obtained from a r and omized clinical trial of provider- vs. counselor-based HIV screening in the ED . We compared the downstream survival , costs , and cost-effectiveness of three HIV screening modalities : 1 ) no screening program ; 2 ) an ED provider-based program ; and 3 ) an HIV counselor-based program . Trial arm-specific data were used for test offer and acceptance rates ( provider offer 36 % , acceptance 75 % ; counselor offer 80 % , acceptance 71 % ) . Undiagnosed HIV prevalence ( 0.4 % ) and linkage to care rates ( 80 % ) were assumed to be equal between the screening modalities . Personnel costs were derived from trial-based re source utilization data . We examined the generalizability of results by conducting sensitivity analyses on offer and acceptance rates , undetected HIV prevalence , and costs . Results Estimated HIV screening costs in the provider and counselor arms averaged $ 8.10 and $ 31.00 per result received . The Provider strategy ( compared to no screening ) had an incremental cost-effectiveness ratio of $ 58,700/ quality -adjusted life year ( QALY ) and the Counselor strategy ( compared to the Provider strategy ) had an incremental cost-effectiveness ratio of $ 64,500/QALY . Results were sensitive to the relative offer and acceptance rates by strategy and the capacity of providers to target-screen , but were robust to changes in undiagnosed HIV prevalence and programmatic costs . Conclusions The cost-effectiveness of provider-based HIV screening in an emergency department setting compares favorably to other US screening programs . Despite its additional cost , counselor-based screening delivers just as much return on investment as provider based-screening . Investment in dedicated HIV screening personnel is justified in situations where ED staff re sources may be insufficient to provide comprehensive , sustainable screening services Introduction Lack of universal , annual testing for human immunodeficiency virus ( HIV ) in health facilities suggests that expansion of HIV testing and counselling ( HTC ) to non- clinical setting s is critical to the achievement of national goals for prevention , care and treatment . Consideration should be given to the ability of lay counsellors to perform home-based HTC in community setting s. Methods We implemented a community cluster r and omized controlled trial of home-based HTC in Sisonke District , South Africa . Trained lay counsellors conducted door-to-door HIV testing using the same rapid tests used by the local health department at the time of the study ( SD Bioline and Sensa ) . To monitor testing quality and counsellor skill , additional dry blood spots were taken and sent for laboratory-based enzyme-linked immunosorbent assay ( ELISA ) testing . Sensitivity and specificity were calculated using the laboratory result as the gold st and ard . Results and discussion From 3986 sample s , the counsellor and laboratory results matched in all but 23 cases . In 18 cases , the counsellor judged the result as indeterminate , whereas the laboratory judged 10 positive , eight negative and three indeterminate , indicating that the counsellor may have erred on the side of caution . Sensitivity was 98.0 % ( 95 % CI : 96.3–98.9 % ) , and specificity 99.6 % ( 95 % CI : 99.4–99.7 % ) , for the lay counsellor field-based rapid tests . Both measures are high , and the lower confidence bound for specificity meets the international st and ard for assessing HIV rapid tests . Conclusions These findings indicate that adequately trained lay counsellors are capable of safely conducting high- quality rapid HIV tests and interpreting the results as per the kit guidelines . These findings are important given the likely expansion of community and home-based testing models and the shortage of clinical ly trained professional staff Home-based voluntary HIV counselling and testing ( HB-VCT ) has been reported to have a high uptake , but it has not been rigorously evaluated . We design ed a model for HB-VCT appropriate for wider scale-up , and investigated the acceptance of home-based counselling and testing , equity in uptake and negative life events with a cluster-r and omized trial . Thirty six rural clusters in southern Zambia were pair-matched based on baseline data and r and omly assigned to the intervention or the control arm . Both arms had access to st and ard HIV testing services . Adults in the intervention clusters were offered HB-VCT by local lay counsellors . Effects were first analysed among those participating in the baseline and post-intervention surveys and then as intention-to-treat analysis . The study was registered with www.controlled-trials.com , number IS RCT N53353725 . A total of 836 and 858 adults were assigned to the intervention and control clusters , respectively . In the intervention arm , counselling was accepted by 85 % and 66 % were tested ( n = 686 ) . Among counselled respondents who were cohabiting with the partner , 62 % were counselled together with the partner . At follow-up eight months later , the proportion of adults reporting to have been tested the year prior to follow-up was 82 % in the intervention arm and 52 % in the control arm ( Relative Risk ( RR ) 1.6 , 95 % CI 1.4 - 1.8 ) , whereas the RR was 1.7 ( 1.4 - 2.0 ) according to the intention-to-treat analysis . At baseline the likelihood of being tested was higher for women vs. men and for more educated people . At follow-up these differences were found only in the control communities . Measured negative life events following HIV testing were similar in both groups . In conclusion , this HB-VCT model was found to be feasible , with a very high acceptance and to have important equity effects . The high couple counselling acceptance suggests that the home-based approach has a particularly high HIV prevention potential HIV-related stigma continues to be a prominent barrier to testing , treatment and care . However , few studies have investigated changes in stigma over time and the factors contributing to these changes , and there is no evidence of the impact of HIV testing and counselling on stigma . This study was nested within a pair-matched cluster-r and omized trial on the acceptance of home-based voluntary HIV counselling and testing conducted in a rural district in Zambia between 2009 and 2011 , and investigated changes in stigma over time and the impact of HIV testing and counselling on stigma . Data from a baseline survey ( n = 1500 ) and a follow-up survey ( n = 1107 ) were used to evaluate changes in stigma . There was an overall reduction of seven per cent in stigma from baseline to follow-up . This was mainly due to a reduction in individual stigmatizing attitudes but not in perceived stigma . The reduction did not differ between the trial arms ( β = -0.22 , p = 0.423 ) . Being tested for HIV was associated with a reduction in stigma ( β = -0.57 , p = 0.030 ) , and there was a trend towards home-based Voluntary Counselling and Testing having a larger impact on stigma than other testing approaches ( β = -0.78 , p = 0.080 vs. β = -0.37 , p = 0.551 ) , possibly explained by a strong focus on counselling and the safe environment of the home . The reduction observed in both arms may give reason to be optimistic as it may have consequences for disclosure , treatment access and adherence . Yet , the change in stigma may have been affected by social desirability bias , as extensive community mobilization was carried out in both arms . The study underscores the challenges in measuring and monitoring HIV-related stigma . Adjustment for social desirability bias and inclusion of qualitative methods are recommended for further studies on the impact of HIV testing on stigma HIV testing and counselling is a critical gateway to prevention and treatment . Yet , coverage remains insufficient , few couples are tested together and gender differences in access exist . We used an embedded mixed methods approach to investigate possible explanations for the high acceptance of home-based voluntary HIV counselling and testing ( HB-VCT ) in a pair-matched cluster-r and omized trial in Zambia . A baseline survey included 1694 individuals in 36 clusters . Adults in 18 intervention clusters were offered HB-VCT by lay counsellors . St and ard testing services were available in both trial arms . After the completion of the intervention , a follow-up survey was conducted in all trial clusters . In addition , 21 in-depth interviews and one focus group discussion were conducted with home-based VCT clients in the intervention arm . Informants favoured the convenience , confidentiality and credibility of HB-VCT . Counsellors were perceived as trustworthy owing to their closeness and conduct , and the consent process was experienced as convincing . Couple testing was selected by 70 % of cohabiting couples and was experienced as beneficial by both genders . Levels of first-time testing ( 68 % vs. 29 % , p < 0.0001 ) and re-testing ( 94 % vs. 74 % , p < 0.0001 ) were higher in the intervention than in the control arm . Acceptance of HIV testing and counselling is dependent on stigma , trust and gender . The confidentiality of home-based VCT was essential for overcoming stigma-related barriers , and the selection of local counsellors was important to ensure trust in the services . The high level of couple counselling within HB-VCT may contribute to closing the gender gap in HIV testing , and has benefits for both genders and potentially for prevention of HIV transmission . The study demonstrates the feasibility of achieving high test coverage with an opt-in consent approach . The embedded qualitative component confirmed the high satisfaction with HB-VCT reported in the quantitative survey and was crucial to fully under
Output:
| Values and preferences studies generally found support for lay providers conducting HTS , particularly in non-hypothetical scenarios .
Uptake of this recommendation could exp and HIV testing to more people globally |
MS213968 | ***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 effectiveness of youth development in reducing teenage pregnancy , substance use , and other outcomes . Design Prospect i ve matched comparison study . Setting 54 youth service sites in Engl and . Participants Young people ( n=2724 ) aged 13 - 15 years at baseline deemed by professionals as at risk of teenage pregnancy , substance misuse , or school exclusion or to be vulnerable . Intervention Intensive , multicomponent youth development programme including sex and drugs education ( Young People ’s Development Programme ) versus st and ard youth provision . Main outcome measures Various , including pregnancy , weekly cannabis use , and monthly drunkenness at 18 months . Results Young women in the intervention group more commonly reported pregnancy than did those in the comparison group ( 16 % v 6 % ; adjusted odds ratio 3.55 , 95 % confidence interval 1.32 to 9.50 ) . Young women in the intervention group also more commonly reported early heterosexual experience ( 58 % v 33 % ; adjusted odds ratio 2.53 , 1.09 to 5.92 ) and expectation of teenage parenthood ( 34 % v 24 % ; 1.61 , 1.07 to 2.43 ) . Conclusions No evidence was found that the intervention was effective in delaying heterosexual experience or reducing pregnancies , drunkenness , or cannabis use . Some results suggested an adverse effect . Although method ological limitations may at least partly explain these findings , any further implementation of such interventions in the UK should be only within r and omised trials To test the effectiveness of a special health care program for adolescent mothers ( 17 years old or younger ) and their infants , 243 mother-infant pairs were r and omly assigned to one of two groups . All of the mothers were unwed , on Medicaid , and black . The control group received routine well-baby care . The experimental group received routine care and services that included rigorous follow-up , discussion s with the mother about her plans for return to school and use of family planning methods , and extra health teaching . The dropout rate in the experimental group ( 60 % ) was significantly less after 18 months than the control group ( 82 % ) . In spite of the high dropout rate , 91 % of the mothers were located for the 18 month follow-up interview . The repeat pregnancy rate in the experimental group was 12 % after 18 months , and 28 % in the control group . There was no significant difference in the percentage returning to school . After 12 months , the infants in the experimental group were more likely to be fully immunized ( 33 % ) than the infants in the control group ( 18 % ) . Mothers in the special care program who continued to attend clinic used the emergency room less than the mothers who continued to attend in the control group . These results suggest that a comprehensive health care program is one way to bring about better outcomes for both adolescent mothers and their infants OBJECTIVE To examine the long-term effects of the Seattle Social Development Project intervention in promoting positive adult functioning and preventing mental health problems , crime , and substance use ( including tobacco , alcohol , and other drugs ) at 21 years of age . DESIGN This nonr and omized controlled trial followed up participants to 21 years of age , 9 years after the intervention ended . We compared the following 3 intervention conditions : a full 6-year intervention ( grade s 1 through 6 ) ; a late 2-year intervention ( grade s 5 and 6 only ) ; and a no-treatment control condition . SETTING Eighteen public elementary schools serving diverse neighborhoods , including high-crime neighborhoods , of Seattle , Wash. PARTICIPANTS A sex-balanced , multiethnic sample of 605 participants across the 3 conditions who completed interviews at 21 years of age ( 94 % of the original sample in these conditions ) . INTERVENTIONS Teacher training in classroom instruction and management , child social and emotional skill development , and parent training . MAIN OUTCOME MEASURES Self-reports of functioning in school and work , emotional and mental health , and crime and substance use at 21 years of age and official court records . RESULTS Broad significant effects on functioning in school and work and on emotional and mental health were found . Fewer significant effects on crime and substance use were found at 21 years of age . Most outcomes had a consistent dose effect , with the strongest effects in subjects in the full-intervention group and effects in the late-intervention group between those in the full-intervention and control groups . CONCLUSIONS A theory-guided preventive intervention that strengthened teaching and parenting practice s and taught children interpersonal skills during the elementary grade s had wide-ranging beneficial effects on functioning in early adulthood CONTEXT . Rates of rapid second births among low-income black adolescent mothers range from 20 % to 50 % . Most efforts to prevent rapid second births have been unsuccessful . OBJECTIVES . There were 4 objectives : ( 1 ) to examine whether a home-based mentoring intervention was effective in preventing second births within 2 years of the adolescent mother 's first delivery ; ( 2 ) to examine whether greater intervention participation increased the likelihood of preventing a second birth ; ( 3 ) to examine whether second births were better predicted from a risk practice perspective or a family formation perspective , based on information collected at delivery ; and ( 4 ) to examine how risk practice s or family formation over the first 2 years of parenthood were related to a second birth . DESIGN . We conducted a r and omized , controlled trial of a home-based intervention curriculum , based on social cognitive theory , and focused on interpersonal negotiation skills , adolescent development , and parenting . The curriculum was delivered biweekly until the infant 's first birthday by college-educated , black , single mothers who served as mentors , presenting themselves as “ big sisters . ” The control group received usual care . Follow-up evaluations were conducted in the homes 6 , 13 , and 24 months after recruitment . METHODS . Participants were recruited from urban hospitals at delivery and were 181 first time , black adolescent mothers ( < 18 years of age ) ; 82 % ( 149 of 181 ) completed the 24-month evaluation . RESULTS . Intent-to-treat analyses revealed that control mothers were more likely than intervention mothers to have a second infant . The complier average causal effect was used to account for variability in intervention participation . Having ≥2 intervention visits increased the odds of not having a second infant more than threefold . Only 1 mother who completed ≥6 visits had a second infant . At delivery of their first infant , mothers who had a second infant were slightly older ( 16.7 vs 16.2 years ) and were more likely to have been arrested ( 30 % vs 14 % ) . There were no differences in baseline contraceptive use or other measures of risk or family formation . At 24 months , mothers who had a second infant reported high self-esteem , positive life events , and romantic involvement and residence with the first infant 's father . At 24 months , there were no differences in marital rates ( 2 % ) , risk practice s , or contraceptive use between mothers who did and did not have a second infant . Mothers who did not have a second infant were marginally more likely to report no plans for contraception in their next sexual contact compared with mothers who had a second infant ( 22 % vs 8 % , respectively ) . CONCLUSIONS . A home-based intervention founded on a mentorship model and targeted toward adolescent development , including negotiation skills , was effective in preventing rapid repeat births among low-income , black adolescent mothers . The effectiveness of the intervention could be seen after only 2 visits and increased over time . There were no second births among mothers who attended ≥8 sessions . There was no evidence that risk behavior or contraceptive use was related to rapid second births . There was some evidence that rapid second births among adolescent mothers were regarded as desirable and as part of a move toward increasing autonomy and family formation , thereby undermining intervention programs that focus on risk avoidance . Findings suggest the merits of a mentoring program for low-income , black adolescent mothers , based on a relatively brief ( 6–8 sessions ) curriculum targeted toward adolescent development and interpersonal negotiation skills OBJECTIVES To test the hypotheses that ( 1 ) a monetary incentive promotes peer-support group participation ; and ( 2 ) peer-support group participation decreases repeat adolescent pregnancies . DESIGN Two-year , prospect i ve , r and omized controlled trial . SETTING Denver , Colo. PARTICIPANTS A total of 286 primiparous girls younger than 18 years , whose infants were younger than 5 months . INTERVENTION Participants were r and omized to 4 interventions : monetary incentive and peer-support group , peer-support group only , monetary incentive only , or no intervention . MAIN OUTCOME MEASURES Consistency of participation in planned intervention and repeat pregnancy . RESULTS Participation in interventions was generally low . Hypothesis 1 was supported : 58 % of those offered a monetary incentive participated in the peer-support groups , compared with 9 % of those who were not offered the incentive . Hypothesis 2 was rejected : the peer-support group experience failed to prevent repeat pregnancies . The incidence of second pregnancies at 6 months ( 9 % , 22/248 ) , at 12 months ( 20 % , 49/248 ) , at 18 months ( 29 % , 72/248 ) , and at 24 months ( 39 % , 97/248 ) following delivery did not vary significantly in relation to intervention strategy . Background sociodemographic characteristics significantly affected the timing of subsequent conceptions but not intervention participation . CONCLUSION A monetary incentive draws adolescent mothers to sites where they can discuss the costs and benefits of contraception and conception with knowledgeable adults and supportive peers . These discussion s do not prevent repeat pregnancies . Further studies are needed to determine if an intervention that produces substantive changes in the daily living environment will eliminate the sexual practice s that are responsible for the high rate of repeat pregnancy in this population Parent training was provided for 80 low-income , black teenage mothers during their infants ' first six months . Half of the mothers were visited biweekly in their homes to be instructed in caregiving and in sensorimotor and interaction exercises , and half were trained as CETA ( Comprehensive Employment Training ACT)-paid , teacher 's aides in a medical school infant nursery that provided care for their infants and infants of medical faculty . Growth and development during the first two years were superior for the infants whose mothers received training , particularly those who received paid parent training as teacher 's aides in the infant nursery . Repeat pregnancy rates were lower and return to work/school rates were higher for the infant nursery mothers , most of whom subsequently pursued nurse 's aide training
Output:
| The results of some systematic review s show no significant overall effect on repeat pregnancy , whereas others show an overall significant reduction .
Youth development programmes are shown in some cases to lower pregnancy rates but in other cases to have no effect or even to increase them . |
MS213969 | ***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: Critical thinking is essential for professional nursing practice . Promoting critical thinking with teaching strategies has been a focus of nursing education and nursing research . Reading and writing assignments are teaching strategies for fostering critical thinking ability . We developed a course with the emphasis on critical reading and writing . The purpose s of this study were to explore the effect of the course and teaching strategies on promoting critical thinking and to underst and the learning experience and perception of nursing students as part of the course assessment plan . Quasi-experimental design and purposive sampling were used . 170 students of a two-year nursing program were grouped into an experimental and a control group depending on whether or not they took the course . The change in critical thinking ability was evaluated and determined based on performance in an article critique test before and after the course . Data was collected with an assessment tool developed for the purpose s of the research and was analyzed with descriptive statistics , paired t-test , and two-factor analysis of variance with repeated measures and content analysis . The findings were : ( 1 ) The scores on the critique test at the end of the course in both groups were significantly higher than before the course ( p<.001 ) . The improvement in score of the experimental group , however , was significantly higher than that of the control group ( p<.001 ) . ( 2 ) Changes in thinking pattern and learning attitude , as well as a feeling of growth and achievement , were found in content analysis of students ' self-evaluation of their learning experience and perception . Critical thinking skills were applied while learning the course . The results not only provide evidence to support the positive effect of reading and writing assignments on critical thinking ability but also confirm the teaching and learning activity design for the course Faculty in an associate degree nursing program at a community college in New York City noted that nursing students lacked critical analysis , problem-solving , and decision-making skills and the reflective ability essential to applying nursing knowledge in clinical situations . This study reports on the use of problem-based learning as a teaching strategy and its impact on the development of critical thinking and communication skills in nursing students BACKGROUND Educational approaches are thought to have facilitative or hindering effects on students ' critical thinking development . The aim of this study was to compare the effects of problem-based learning ( PBL ) and lecturing approaches on the development of students ' critical thinking . METHODS All 79 Year 1 undergraduate nursing students at a university in Hong Kong were r and omly assigned to 1 of 2 parallel courses delivered by either PBL ( n = 40 ) or lecturing ( n = 39 ) over 1 academic year . The primary outcome measure was students ' critical thinking disposition as measured by the California Critical Thinking Disposition Inventory ( CCTDI ) . Individual interviews were also conducted to elicit the students ' perceptions of their learning experience . Data were collected at 4 timepoints spanning 3 years . RESULTS The overall CCTDI and subscale scores for the PBL group were not significantly different from those of the lecture group at the first timepoint ( pretest ) . Compared with lecture students , PBL students showed significantly greater improvement in overall CCTDI ( P = 0.0048 ) , Truthseeking ( P = 0.0008 ) , Analyticity ( P = 0.0368 ) and Critical Thinking Self-confidence ( P = 0.0342 ) subscale scores from the first to the second timepoints ; in overall CCTDI ( P = 0.0083 ) , Truthseeking ( P = 0.0090 ) and Analyticity ( P = 0.0354 ) subscale scores from the first to the third timepoints ; and in Truthseeking ( P = 0.0173 ) and Systematic ity ( P = 0.0440 ) subscale scores from the first to the fourth timepoints . CONCLUSIONS There were significant differences in the development of students ' critical thinking dispositions between those who undertook the PBL and lecture courses , respectively The aim of this study was to compare the learning effectiveness of peer tutored problem-based learning and conventional teaching of nursing ethics in Taiwan . The study adopted an experimental design . The peer tutored problem-based learning method was applied to an experimental group and the conventional teaching method to a control group . The study sample consisted of 142 senior nursing students who were r and omly assigned to the two groups . All the students were tested for their nursing ethical discrimination ability both before and after the educational intervention . A learning satisfaction survey was also administered to both groups at the end of each course . After the intervention , both groups showed a significant increase in ethical discrimination ability . There was a statistically significant difference between the ethical discrimination scores of the two groups ( P < 0.05 ) , with the experimental group on average scoring higher than the control group . There were significant differences in satisfaction with self-motivated learning and critical thinking between the groups . Peer tutored problem-based learning and lecture-type conventional teaching were both effective for nursing ethics education , but problem-based learning was shown to be more effective . Peer tutored problem-based learning has the potential to enhance the efficacy of teaching nursing ethics in situations in which there are personnel and re source constraints
Output:
| The results of the current meta- analysis indicate that problem-based learning might help nursing students to improve their critical thinking . |
MS213970 | ***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: Twenty-seven patients presenting within 5 days of the onset of crystalline proven acute gout were prospect ively treated with either indomethacin 50 mg tid or triamcinolone acetonide 60 mg intramuscularly . Patients with contraindications to therapy with indomethacin received triamcinolone acetonide . They were followed for 30 days . Resolution of all symptoms occurred at an average of 8 days for the indomethacin patients and 7 days in the triamcinolone patients . No side effects or episodes of rebound gout attacks occurred with the triamcinolone acetonide therapy . It is as safe and effective as indomethacin in the treatment of acute gout , and is particularly useful in patients with contraindications to therapy with nonsteroidal antiinflammatory drugs A double-blind , parallel group study was carried out in 61 patients suffering from acute gouty arthritis to compare the effectiveness of etodolac and naproxen in the relief of symptoms . Patients were allocated at r and om to receive either 300 mg etodolac twice daily ( 31 patients ) or 500 mg naproxen twice daily ( 30 patients ) for 7 days . Both groups were comparable for sex , age and weight of patients , but there was a tendency for patients in the etodolac group to have more severe gout as shown by baseline clinical assessment scores . The variables assessed on entry and on Days 2 , 4 and 7 of treatment were pain intensity , swelling , tenderness , erythema , joint heat , range of motion , and physician 's and patients ' overall evaluation of the condition . The results showed that there was a significant improvement from baseline in all of the variables at each time point in both treatment groups . However , more etodolac-treated patients ( 81 % ) than naproxen-treated patients ( 53 % ) showed overall improvement at Day 2 , and etodolac was significantly better than naproxen on the Day 2 evaluation of joint swelling and at the Day 4 evaluations of joint tenderness , range of motion and the physician 's global assessment . At the final evaluation on Day 7 , 97 % of the etodolac group reported that their condition had improved as compared to 93 % of the naproxen group . Both drugs were well tolerated and only a few mild side-effects were reported A double-blind study was carried out to compare the effects of ketoprofen and phenylbutazone in acute gouty arthritis . Two groups of patients , each consisting of 23 males , received intramuscular injections of either phenylbutazone ( 2 X 300 mg daily ) or ketoprofen ( 2 X 50 mg daily ) for a period of 7 days . The drug effects were assessed both subjectively and objective ly . There was an excellent therapeutic effect in both groups . In general , no statistically-significant differences were detected between the two preparations . However , ketoprofen appears to be slightly better tolerated with respect to the incidence of systemic and local side effects . Thus , the administration of ketoprofen can be recommended in cases of acute gouty arthritis Introduction In phase-3 clinical trials , the interleukin ( IL-1 ) blocker , rilonacept ( IL-1 Trap ) , demonstrated efficacy for gout flare prevention during initiation of urate-lowering therapy . This trial evaluated rilonacept added to a st and ard-of-care , indomethacin , for treatment of acute gout flares . Methods Adults , aged 18 - 70 years , with gout presenting within 48 hours of flare onset and having at least moderate pain as well as swelling and tenderness in the index joint were r and omized to subcutaneous ( SC ) rilonacept 320 mg at baseline plus oral indomethacin 50 mg TID for 3 days followed by 25 mg TID for up to 9 days ( n = 74 ) ; SC placebo at baseline plus oral indomethacin as above ( n = 76 ) ; or SC rilonacept 320 mg at baseline plus oral placebo ( n = 75 ) . The primary efficacy endpoint was change in pain in the index joint ( patient-reported using a Likert scale ( 0 = none ; 4 = extreme ) ) from baseline to the average of values at 24 , 48 and 72 hours ( composite time point ) for rilonacept plus indomethacin versus indomethacin alone . Comparison of rilonacept monotherapy with indomethacin monotherapy was dependent on demonstration of significance for the primary endpoint . Safety evaluation included clinical laboratory and adverse event ( AE ) assessment s. Results Patient characteristics were comparable among the groups ; the population was predominantly male ( 94.1 % ) , white ( 75.7 % ) , with mean ± SD age of 50.3 ± 10.6 years . All treatment groups reported within-group pain reductions from baseline ( P < 0.0001 ) . Although primary endpoint pain reduction was greater with rilonacept plus indomethacin ( -1.55 ± 0.92 ) relative to indomethacin alone ( -1.40 ± 0.96 ) , the difference was not statistically significant ( P = 0.33 ) , so formal comparison between monotherapy groups was not performed . Pain reduction over the 72-hour period with rilonacept alone ( -0.69 ± 0.97 ) was less than that in the other groups , but pain reduction was similar among groups at 72 hours . Treatment with rilonacept was well-tolerated with no reported serious AEs related to rilonacept . Across all groups , the most frequent AEs were headache and dizziness . Conclusions Although generally well-tolerated , rilonacept in combination with indomethacin and rilonacept alone did not provide additional pain relief over 72 hours relative to indomethacin alone in patients with acute gout flare . Trial registration Clinical Trials.gov registration number NCT00855920 A double-blind trial was carried out in 24 patients with acute gout to compare the efficacy and tolerance of feprazone , a non-steroidal anti-inflammatory drug , with that of phenylbutazone . Patients received 800 mg of either drug daily for 2 days and then 600 mg daily for up to 8 days . The results of patient assessment showed there was no significant difference between the two groups in time taken either to significant improvement or to final resolution of the gout attack . No side-effects were reported with either drug ABSTRACT Background and objective : Disease history and clinical features can influence treatment response in patients with acute gout . The purpose of this pooled subgroup analysis was to assess the association of baseline disease and patient characteristics with response to treatment in acute gout using data from two identical studies . Methods : Patients ≥ 18 years of age with onset of acute gout within 48 h associated with moderate , severe , or extreme pain involving less than four joints were eligible for inclusion in the primary studies , and were r and omized to etoricoxib 120 mg once daily ( N = 178 ) or indomethacin 50 mg three times daily ( N = 161 ) . The primary and secondary efficacy endpoints were analyzed using an analysis of covariance model to detect potential differential treatment responses across several subgroups : joint involvement ( mono-articular vs. oligo-articular ) , baseline pain severity ( moderate vs. severe ) , concomitant allopurinol and /or colchicine use ( users vs. nonusers ) , age ( < 45 , 45–55 , and > 55 years ) , gender , and race ( white or other ) . Results : Overall , etoricoxib and indomethacin demonstrated comparable efficacy across all subgroups . Compared with patients with oligo-articular disease , those with mono-articular disease had significantly greater improvements in patient assessment of pain , patient global assessment of response to therapy ( PGART ) , investigator global assessment of response to therapy ( IGART ) , and study joint tenderness ( p < 0.001 for all ) . Greater improvements were seen in patient assessment of pain ( p < 0.001 ) and study joint tenderness ( p < 0.05 ) for severe/extreme baseline pain compared with moderate baseline pain . Concomitant use of colchicine and /or allopurinol was associated with significantly worse IGART ( p < 0.05 ) . Conclusions : This pooled subgroup analysis demonstrated significantly greater response of acute gout to either etoricoxib or indomethacin among those with monoarticular disease , severe/extreme baseline pain , and non-use of colchicine and /or allopurinol . These results should be interpreted in the context of a pooled subgroup analysis with a limited sample size , and with the underst and ing that associations identified in such analyses do not define causation . Despite limitations , the results provide insights into the types of patients more likely to respond better to anti-inflammatory medication , and reiterate the importance of earlier effective control of the disease Objective . To evaluate the analgesic efficacy of high-dose celecoxib in the treatment of moderate to extreme pain and inflammation associated with acute gouty arthritis . Methods . A multinational , r and omized , double-blind , double-dummy , active-controlled trial was done with patients ( aged ≥ 18 years ) with acute gouty monoarthritis or oligoarthritis ( onset of pain ≤ 48 h before enrollment ) . Patients were treated for 8 days with 1 week followup and were r and omized 1:1:1:1 to receive celecoxib 50 mg bid , celecoxib 400 mg ( followed by 200 mg later on Day 1 and then 200 mg bid for 7 days ) , celecoxib 800 mg ( followed by 400 mg later on Day 1 and then 400 mg bid for 7 days ) , or indomethacin 50 mg tid . Results . Of 443 patients screened , 402 were r and omized and 400 received treatment . Baseline demographics were comparable among treatments . Patients receiving high-dose celecoxib ( 800/400 mg ) experienced a significantly greater reduction in pain intensity on Day 2 compared with low-dose celecoxib 50 mg bid [ least squares ( LS ) mean difference −0.46 ; p = 0.0014 ] . For high-dose celecoxib 800/400 mg , the change in pain scores from baseline to Day 2 was comparable with indomethacin 50 mg tid ( LS mean difference 0.11 ; p = 0.4331 ) . There were significant differences in adverse events when the combined celecoxib groups ( 29.5 % ) were compared with patients taking indomethacin ( 43.1 % ; p = 0.0116 ) . There was no change in median serum creatinine levels for any treatment . There were more discontinuations due to adverse events ( 8.8 % vs 3 % ; p = 0.0147 ) with indomethacin than with the combined celecoxib groups . Conclusion . High-dose celecoxib ( 800/400 mg ) was significantly more effective than low-dose celecoxib ( 50 mg bid ) and comparable to indomethacin in the treatment of moderate to extreme pain in patients with acute gouty arthritis . Further , celecoxib was well tolerated Eighteen patients ( 11 men and 7 women ) suffering from primary or secondary gout , were treated with either proquazone or indomethacin for acute attacks in a double-blind study . There were 9 patients in each treatment group . A marked improvement of clinical symptoms appeared in 2 - 3 days . In the proquazone group , complete remission was achieved in 6 patients , a good result in one , and a slight improvement in one patient , whereas one patient did not respond to treatment . The corresponding figures for the indomethacin group were 4 cases with complete remission , 4 with a good result , and one not responding to treatment . A significant decrease in s-uric acid values was noted in the proquazone group . In this group too , mild gastrointestinal symptoms appeared in 2 patients Study objective We compare the analgesic efficacy and adverse effects of oral prednisolone/acetaminophen and oral indomethacin/acetaminophen combination therapy in the treatment of acute goutlike arthritis in patients presenting to an emergency department ( ED ) . Methods This is a double-blind , r and omized , controlled study in a university hospital emergency department ( ED ) in the New Territories of Hong Kong . Patients older than 17 years and presenting between February 1 , 2003 , and June 30 , 2004 , with a clinical diagnosis of goutlike arthritis were r and omized to receive either oral prednisolone/acetaminophen or oral indomethacin/acetaminophen combination therapy . Primary outcome measures were pain scores , time to resolution of symptoms and signs , and adverse effects . Secondary outcome measures were the need for additional acetaminophen and relapse rate . Results There were 90 patients r and omized : 46 patients to the indomethacin group and 44 patients to the prednisolone group . Baseline characteristics , including pain scores , were similar in the 2 groups . Both treatment groups had a similar decrease in pain score in the ED . The mean rate of decrease in pain score with activity for indomethacin was −1.7±1.6 ( SD ) mm per day and for prednisolone was −2.9±2.0 ( SD ) mm per day ( mean difference 1.2 mm/day ; 95 % confidence interval 0.4 to 2.0 mm
Output:
| Moderate- quality evidence based upon four trials ( 974 participants ) indicated that NSAIDs and COXIBs produced similar benefits in terms of pain , swelling and global improvement , but COXIBs were associated with fewer adverse events .
The trials did not measure participant-reported global assessment and health-related quality of life .
Limited evidence supported the use of NSAIDs in the treatment of acute gout .
While these data were insufficient to draw firm conclusions , they did not conflict with clinical guideline recommendations based upon evidence from observational studies , other inflammatory arthritis and expert consensus , which support the use of NSAIDs in acute gout .
Moderate- quality evidence suggested that selective COX-2 inhibitors and non-selective NSAIDs are probably equally beneficial although COX-2 inhibitors are likely to be associated with significantly fewer total and gastrointestinal adverse events .
Moderate- quality evidence indicated that systemic glucocorticoids and NSAIDs were also equally beneficial in terms of pain relief .
There were no withdrawals due to adverse events and total adverse events were similar between groups .
There was low- quality evidence that there was no difference in function . |
MS213971 | ***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: Five experiments are reported showing that the interpretation of personally relevant emotional information can be modified by systematic exposure to congruent exemplars . Participants were induced to interpret ambiguous information in a relatively threatening or a benign way . Comparison with a baseline condition suggested that negative and positive induction had similar but opposing effects . Induction of an interpretative bias did not require active generation of personally relevant meanings , but such active processing was necessary before state anxiety changed in parallel with the induced interpretative bias . These findings provide evidence consistent with a causal link between the deployment of interpretative bias and anxiety and reveal something of the processes underlying this association
Output:
| Interestingly , within these models , interpretational processes may also occur following attentional selection of emotionally relevant stimuli .
This contrasts with the Threat Interpretation Model in which interpretation precedes attention . |
MS213972 | ***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 Trimodality therapy seems to be the best treatment for malignant pleural mesothelioma ( MPM ) . A large experience served to evaluate the efficacy of surgery followed by adjuvant chemo-radiotherapy . Trimodality therapy results have led us to test induction chemotherapy followed by EPP and adjuvant radiotherapy in stages I-III of MPM . The aim of our study was to evaluate the feasibility of this protocol and to estimate survival . METHODS From 2000 to 2003 , 21 patients with MPM ( 14 males and 7 females , median age 59 years ) were enrolled in the prospect i ve study . Induction chemotherapy consisted of Carboplatin ( AUC 5mg/mL/min on Day 1 ) and Gemcitabine ( 1000mg/m(2 ) on Days 1 , 8 , 15 ) for three to four cycles . EPP was performed 3 - 5 weeks after induction therapy , while post-operative RT was given 4 - 6 weeks after operation . RESULTS Ten patients received three cycles of chemotherapy , 10 patients received four cycles and 1 patient had two cycles . Grade s 3 - 4 haematological toxicity occurred in eight ( 38.1 % ) patients . Chemotherapy response rate was : complete 0 % , partial 33.3 % and stable disease 66.7 % . Seventeen ( 80.9 % ) out of 21 patients underwent EPP with no intra or post-operative mortality with an overall major and minor morbidity rate at 52.4 % . Median survival was 25.5 months , with an overall 1 , 3 and 5-year survival rate of 71 , 33 and 19 % , respectively . CONCLUSIONS In MPM , the combined modality approach using the Carboplatin/Gemcitabine combination as induction chemotherapy is feasible , with good results in terms of survival and morbidity . Our results are similar to those of other studies using a heavier modality treatment Summary Background The effects of extra-pleural pneumonectomy ( EPP ) on survival and quality of life in patients with malignant pleural mesothelioma have , to our knowledge , not been assessed in a r and omised trial . We aim ed to assess the clinical outcomes of patients who were r and omly assigned to EPP or no EPP in the context of trimodal therapy in the Mesothelioma and Radical Surgery ( MARS ) feasibility study . Methods MARS was a multicentre r and omised controlled trial in 12 UK hospitals . Patients aged 18 years or older who had pathologically confirmed mesothelioma and were deemed fit enough to undergo trimodal therapy were included . In a prer and omisation registration phase , all patients underwent induction platinum-based chemotherapy followed by clinical review . After further consent , patients were r and omly assigned ( 1:1 ) to EPP followed by postoperative hemithorax irradiation or to no EPP . R and omisation was done central ly with computer-generated permuted blocks stratified by surgical centre . The main endpoints were feasibility of r and omly assigning 50 patients in 1 year ( results detailed in another report ) , proportion r and omised who received treatment , proportion eligible ( registered ) who proceeded to r and omisation , perioperative mortality , and quality of life . Patients and investigators were not masked to treatment allocation . This is the principal report of the MARS study ; all patients have been recruited . Analyses were by intention to treat . This trial is registered , number IS RCT N95583524 . Findings Between Oct 1 , 2005 , and Nov 3 , 2008 , 112 patients were registered and 50 were subsequently r and omly assigned : 24 to EPP and 26 to no EPP . The main reasons for not proceeding to r and omisation were disease progression ( 33 patients ) , inoperability ( five patients ) , and patient choice ( 19 patients ) . EPP was completed satisfactorily in 16 of 24 patients assigned to EPP ; in five patients EPP was not started and in three patients it was ab and oned . Two patients in the EPP group died within 30 days and a further patient died without leaving hospital . One patient in the no EPP group died perioperatively after receiving EPP off trial in a non-MARS centre . The hazard ratio [ HR ] for overall survival between the EPP and no EPP groups was 1·90 ( 95 % CI 0·92–3·93 ; exact p=0·082 ) , and after adjustment for sex , histological subtype , stage , and age at r and omisation the HR was 2·75 ( 1·21–6·26 ; p=0·016 ) . Median survival was 14·4 months ( 5·3–18·7 ) for the EPP group and 19·5 months ( 13·4 to time not yet reached ) for the no EPP group . Of the 49 r and omly assigned patients who consented to quality of life assessment ( EPP n=23 ; no EPP n=26 ) , 12 patients in the EPP group and 19 in the no EPP group completed the quality of life question naires . Although median quality of life scores were lower in the EPP group than the no EPP group , no significant differences between groups were reported in the quality of life analyses . There were ten serious adverse events reported in the EPP group and two in the no EPP group . Interpretation In view of the high morbidity associated with EPP in this trial and in other non-r and omised studies a larger study is not feasible . These data , although limited , suggest that radical surgery in the form of EPP within trimodal therapy offers no benefit and possibly harms patients . Funding Cancer Research UK ( CRUK/04/003 ) , the June Hancock Mesothelioma Research Fund , and Guy 's and St Thomas ' NHS Foundation Trust Malignant pleural mesothelioma ( MPM ) is a rare tumour but with increasing incidence and a poor prognosis . In 2008 , the European Respiratory Society/European Society of Thoracic Surgeons Task Force brought together experts to propose practical and up-to- date d guidelines on the management of MPM . To obtain an earlier and reliable diagnosis of MPM , the experts recommend performing thoracoscopy , except in cases of pre-operative contraindication or pleural symphysis . The st and ard staining procedures are insufficient in ∼10 % of cases . Therefore , we propose using specific immunohistochemistry markers on pleural biopsies . In the absence of a uniform , robust and vali date d staging system , we advice use of the most recent TNM based classification , and propose a three step pre-treatment assessment . Patient 's performance status and histological subtype are currently the only prognostic factors of clinical importance in the management of MPM . Other potential parameters should be recorded at baseline and reported in clinical trials . MPM exhibits a high resistance to chemotherapy and only a few patients are c and i date s for radical surgery . New therapies and strategies have been review ed . Because of limited data on the best combination treatment , we emphasise that patients who are considered c and i date s for a multimodal approach should be included in a prospect i ve trial at a specialised centre The European Organisation for Research and Treatment of Cancer ( EORTC ; protocol 08031 ) phase II trial investigated the feasibility of trimodality therapy consisting of induction chemotherapy followed by extrapleural pneumonectomy and post-operative radiotherapy in patients with malignant pleural mesothelioma ( with a severity of cT3N1M0 or less ) . Induction chemotherapy consisted of three courses of cisplatin 75 mg·m−2 and pemetrexed 500 mg·m−2 . Nonprogressing patients underwent extrapleural pneumonectomy followed by post-operative radiotherapy ( 54 Gy , 30 fractions ) . Our primary end-point was “ success of treatment ” and our secondary end-points were toxicity , and overall and progression-free survival . 59 patients were registered , one of whom was ineligible . Subjects ’ median age was 57 yrs . The subjects ’ TNM scores were as follows : cT1 , T2 and T3 , 36 , 16 and six patients , respectively ; cN0 and N1 , 57 and one patient , respectively . 55 ( 93 % ) patients received three cycles of chemotherapy with only mild toxicity . 46 ( 79 % ) patients received surgery and 42 ( 74 % ) had extrapleural pneumonectomy with a 90-day mortality of 6.5 % . Post-operative radiotherapy was completed in 37 ( 65 % ) patients . Grade 3–4 toxicity persisted after 90 days in three ( 5.3 % ) patients . Median overall survival time was 18.4 months ( 95 % CI 15.6–32.9 ) and median progression-free survival was 13.9 months ( 95 % CI 10.9–17.2 ) . Only 24 ( 42 % ) patients met the definition of success ( one-sided 90 % CI 0.36–1.00 ) . Although feasible , trimodality therapy in patients with mesothelioma was not completed within the strictly defined timelines of this protocol and adjustments are necessary Purpose : MORAb-009 is a chimeric monoclonal antibody that targets mesothelin , a tumor differentiation antigen overexpressed in pancreatic cancer , ovarian cancer , mesothelioma , and other malignancies . We conducted a phase I clinical trial of MORAb-009 in patients with advanced mesothelin-expressing cancers to determine its safety , dose-limiting toxicity ( DLT ) , and maximum tolerated dose ( MTD ) . Methods : Cohorts consisting of 3 to 6 subjects each received MORAb-009 intravenously on days 1 , 8 , 15 , and 22 at progressively increasing doses ranging from 12.5 to 400 mg/m2 . Disease evaluation with computed tomography occurred on day 35 . Subjects with responding or stable disease could receive additional cycles of MORAb-009 . Results : A total of 24 subjects were treated including 13 mesothelioma , 7 pancreatic cancer , and 4 ovarian cancer patients . The median number of MORAb-009 infusions was 4 ( range 1–24 infusions ) . At the 400 mg/m2 dose level , 2 subjects experienced DLT ( grade 4 transaminitis and a grade 3 serum sickness ) . Thus , although there were other contributing causes of these adverse events , 200 mg/m2 was considered the MTD . Other adverse events at least possibly related to MORAb-009 included 7 drug hypersensitivity events ( all grade 1 or 2 ) and a thromboembolic event ( grade 4 ) . Eleven subjects had stable disease . There was a dose-dependent increase in serum MORAb-009 concentration . Conclusion : MORAb-009 is well tolerated and the MTD when administered weekly is conservatively set at 200 mg/m2 . In this group of previously treated patients , 11 subjects had stable disease . Phase II studies of MORAb-009 in different mesothelin-expressing cancers are ongoing PURPOSE Patients with malignant pleural mesothelioma , a rapidly progressing malignancy with a median survival time of 6 to 9 months , have previously responded poorly to chemotherapy . We conducted a phase III trial to determine whether treatment with pemetrexed and cisplatin results in survival time superior to that achieved with cisplatin alone . PATIENTS AND METHODS Chemotherapy-naive patients who were not eligible for curative surgery were r and omly assigned to receive pemetrexed 500 mg/m2 and cisplatin 75 mg/m2 on day 1 , or cisplatin 75 mg/m2 on day 1 . Both regimens were given intravenously every 21 days . RESULTS A total of 456 patients were assigned : 226 received pemetrexed and cisplatin , 222 received cisplatin alone , and eight never received therapy . Median survival time in the pemetrexed/cisplatin arm was 12.1 months versus 9.3 months in the control arm ( P = .020 , two-sided log-rank test ) . The hazard ratio for death of patients in the pemetrexed/cisplatin arm versus those in the control arm was 0.77 . Median time to progression was significantly longer in the pemetrexed/cisplatin arm : 5.7 months versus 3.9 months ( P = .001 ) . Response rates were 41.3 % in the pemetrexed/cisplatin arm versus 16.7 % in the control arm ( P < .0001 ) . After 117 patients had enrolled , folic acid and vitamin B12 were added to reduce toxicity , result ing in a significant reduction in toxicities in the pemetrexed/cisplatin arm . CONCLUSION Treatment with pemetrexed plus cisplatin and vitamin supplementation result ed in superior survival time , time to progression , and response rates compared with treatment with cisplatin alone in patients with malignant pleural mesothelioma . Addition of folic acid and vitamin B12 significantly reduced toxicity without adversely affecting survival time BACKGROUND The aim of this multicenter trial was to prospect ively evaluate neo-adjuvant chemotherapy followed by extrapleural pneumonectomy ( EPP ) and radiotherapy , including quality of life as outcome . PATIENTS AND METHODS Eligible patients had malignant pleural mesothelioma of all histological types , World Health Organization performance status
Output:
| However , a small study assessing the feasibility of conducting a r and omized controlled trial for TMT versus conservative treatment reported poor short- and long-term outcomes for patients who underwent pneumonectomy .
Overall , results of the present systematic review suggest TMT may offer acceptable perioperative outcomes and long-term survival in selected patients treated in specialized centers |
MS213973 | ***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 Porous titanium granules ( PTG ) may have potential as an osteoconductive bone graft substitute to treat peri-implant osseous defects . The aim of this study was to analyze clinical and radiographic outcomes of peri-implant osseous defects after treatment with PTG . MATERIAL S AND METHODS This prospect i ve , r and omized , case-control , clinical 12-month study compared open-flap debridement and surface decontamination with titanium curettes and 24 % ethylenediaminetetraacetic acid gel ( n = 16 ) to the same protocol but with the addition of PTG ( n = 16 ) . One- , two- , and three-wall infrabony defects were included . Patients were given amoxicillin and metronidazole 3 days before surgery and for 7 days afterwards . Implants were submerged and allowed to heal for 6 months . Probing pocket depths , bleeding on probing , implant stability using resonance frequency analysis , and radiographic evaluation were performed at baseline and at 12 months . The threshold for significance was set at .05 . RESULTS Change in radiographic defect height and percent fill of the peri-implant osseous defect significantly favored patients treated with PTG . Both treatment modalities demonstrated significant improvements in probing pocket depth , but significant differences between groups were not observed . The PTG-treated implants showed an increase in implant stability quotient ( ISQ ) of 1.6 units , compared with a decrease of 0.7 ISQ for the control group . No adverse effects were associated with PTG treatment . CONCLUSIONS Reconstruction with PTG result ed in significantly better radiographic peri-implant defect fill compared with controls ; however , the results do not necessarily imply reosseointegration or osseointegration of PTG particles . Improvements in clinical parameters were seen in both groups , but no differences between groups were demonstrated Objectives The aim of the present study is to report on preliminary clinical and radiographic results of using porous titanium granules for treatment of peri-implantitis lesions . Methods A retrospective cohort of 18 implants presenting with peri-implantitis in 16 consecutive patients from two private practice s had been evaluated . Treatment included open flap debridement of the lesion , implant surface decontamination using tetracycline , filling of the defect with porous titanium granules and apically positioning of the flaps . Patients ' demographics , site and implant characteristics , as well as clinical and radiographic evaluation as baseline and time of follow-up were recorded . Results Patients ' age ranged from 44 to 79 years with a mean of 61.3 ± 9.5 years . Follow-up time after treating peri-impantitis lesions ranged from 6 to 15 months ( mean 7.5 ± 3.9 ) . Two out of the 18 implants still presented with bleeding and suppuration at follow-up and thus the treatment was considered as a failure . This result ed in an overall success rate of 88 % for the treatment . Mean bone loss prior to treatment was 4.4 ± 2.1 mm and was reduced following treatment to 2.3 ± 2.1 mm . Conclusion The use of porous titanium granules might be a viable treatment option in cases of peri-implantitis lesions . Further large-scale long-term studies are warranted in order to assess the additional benefit from this treatment option compared to other available alternatives . BACKGROUND Limited evidence exists on the efficacy of regenerative treatment of peri-implantitis . MATERIAL AND METHODS Subjects receiving antibiotics and surgical debridement were r and omly assigned to placement of autogenous bone ( AB ) or bovine-derived xenograft ( BDX ) and with placement of a collagen membrane . The primary outcome was evidence of radiographic bone fill and the secondary outcomes included reductions of probing depth ( PD ) bleeding on probing ( BOP ) and suppuration . RESULTS Twenty-two subjects were included in the AB and 23 subjects in the BDX group . Statistical analysis failed to demonstrate differences for 38/39 variables assessed at baseline . At 12 months , significant better results were obtained in the BDX group for bone levels ( p < 0.001 ) , BOP ( p = 0.004 ) , PI ( p = 0.003 ) and suppuration ( p < 0.01 ) . When adjusting for number of implants treated per subject , a successful treatment outcome PD ≤ 5.0 mm , no pus , no bone loss and BOP at 1/4 or less sites the likelihood of defect fill was higher in the BDX group ( LR : 3.2 , 95 % CI : 1.0 - 10.6 , p < 0.05 ) . CONCLUSIONS Bovine xenograft provided more radiographic bone fill than AB . The success for both surgical regenerative procedures was limited . Decreases in PD , BOP , and suppuration were observed OBJECTIVES To evaluate the extent of bone fill over 3 years following the surgical treatment of peri-implantitis with bone grafting with or without a membrane . MATERIAL AND METHODS In a non-submerged wound-healing mode , 15 subjects with 27 implants were treated with a bone substitute ( Algipore ( ® ) ) alone and 17 subjects with 29 implants were treated with the bone substitute and a resorbable membrane ( Osseoquest ( ® ) ) . Implants with radiographic bone loss ≥1.8 mm following the first year in function and with bleeding and /or pus on probing were included . Following surgery , subjects were given systemic antibiotics ( 10 days ) and rinsed with chlorhexidine . After initial healing , the subjects were enrolled in a strict maintenance programme . RESULTS Statistical analysis failed to demonstrate changes in bone fill between 1 and 3 years both between and within procedure groups . The mean defect fill at 3 years was 1.3 ± ( SD ) 1.3 mm if treated with the bone substitute alone and 1.6 ± ( SD ) 1.2 mm if treated with an adjunct resorbable membrane , ( p=0.40 ) . The plaque index decreased from approximately 40 - 10 % , remaining stable during the following 2 years . CONCLUSION Defect fill using a bone substitute with or without a membrane technique in the treatment of peri-implantitis can be maintained over 3 years OBJECTIVES The aim of the present case series was to evaluate the 2-year results obtained following treatment of peri-implantitis lesions using either a nanocrystalline hydroxyapatite ( NHA ) or a natural bone mineral in combination with a collagen membrane ( NBM+CM ) . MATERIAL AND METHODS Twenty-two patients suffering from moderate peri-implantitis ( n=22 intra-bony defects ) were r and omly treated with ( i ) access flap surgery ( AFS ) and the application of NHA , or with AFS and the application of NBM+CM . Clinical parameters were recorded at baseline and after 12 , 18 , and 24 months of non-submerged healing . RESULTS Two patients from the NHA group were excluded from the study due to severe pus formation at 12 months . At 24 months , both groups revealed clinical ly important probing depth ( PD ) reductions ( NHA : 1.5+/-0.6 mm ; NBM+CM : 2.4+/-0.8 mm ) and clinical attachment level ( CAL ) gains ( NHA : 1.0+/-0.4 mm ; NBM+CM : 2.0+/-0.8 mm ) . However , these clinical improvements seemed to be better in the NBM+CM group ( difference between groups : PD reduction : 0.9+/-0.2 mm ; CAL gain : 1.0+/-0.3 mm ) . CONCLUSION Both treatment procedures have shown efficacy over a period of 24 months , however , the application of NBM+CM may result in an improved outcome of healing The CONSORT ( Consoli date d St and ards of Reporting Trials ) statement is used worldwide to improve the reporting of r and omized , controlled trials . Schulz and colleagues describe the latest version , CONSORT 2010 , which up date s the reporting guideline based on new method ological evidence and accumulating experience . & NA ; Between 1994 and 1999 , 50 patients were treated with either profound parodontopathy ( 30 ) or periimplantitis ( 20 ) . Half of each of the two groups of patients was treated conventionally , and the other half was treated with laser support . Before the operation , microbiological examinations were carried out , in addition to registering the clinical findings and taking x‐rays . These procedures were repeated after the operation , and again after 6 , 12 , 24 , 36 , 48 , and 60 months . The surgical part of therapy for each half of the patient groups included surface decontamination with diode laser light ( 1‐watt output , maximum of 20 seconds ) in addition to conventional procedures . The values of the laser‐supported therapy were lower than those specified in the relevant literature . The relapse rate of the two diseases ( 13 % for the periimplantitis and 23 % for the parodontopathy group ) after 5 years was lower than the comparative values of research ed literature where decontamination was not included in the therapy . We think that integrating diode laser light decontamination in the approved treatment schemes for periimplantitis and parodontitis contributes considerably to the success of this therapy . ( Implant Dent 2000;9:247‐251 AIM The objective of this r and omized , double-blind , placebo-controlled trial was to study the effect of implant surface decontamination with chlorhexidine (CHX)/cetylpyridinium chloride ( CPC ) on microbiological and clinical parameters . MATERIAL & METHODS Thirty patients ( 79 implants ) with peri-implantitis were treated with resective surgical treatment consisting of apically re-positioned flap , bone re-contouring and surface debridement and decontamination . Patients were r and omly allocated to decontamination with 0.12 % CHX + 0.05 % CPC ( test-group ) or a placebo-solution ( without CHX/CPC , placebo-group ) . Microbiological parameters were recorded during surgery ; clinical and radiographical parameters were recorded before ( pre- ) treatment ( baseline ) , and at 3 , 6 and 12 months after treatment . RESULTS Nine implants in two patients in the placebo-group were lost due to severe persisting peri-implantitis . Both decontamination procedures result ed in significant reductions of bacterial load on the implant surface , but the test-group showed a significantly greater reduction than the placebo-group ( log 4.21 ± 1.89 versus log 2.77 ± 2.12 , p = 0.006 ) . Multilevel analysis showed no differences between both groups in the effect of the intervention on bleeding , suppuration , probing pocket depth and radiographical bone loss over time . CONCLUSION Implant surface decontamination with 0.12 % CHX + 0.05 % CPC in resective surgical treatment of peri-implantitis leads to a greater immediate suppression of anaerobic bacteria on the implant surface than a placebo-solution , but does not lead to superior clinical results . The long-term microbiological effect remains unknown OBJECTIVES The study aim ed at investigating the impact of two surface debridement/decontamination ( DD ) methods on the clinical outcomes of combined surgical treatment of peri-implantitis . MATERIAL AND METHODS Thirty-two patients suffering from advanced peri-implantitis ( n=38 combined supra- and intra-bony defects ) were treated with flap surgery , granulation tissue removal , and implantoplasty at buccally and supracrestally exposed implant parts . The intra-bony aspects were r and omly allocated to surface DD using either ( i ) an Er : YAG laser ( ERL ) device , or ( ii ) plastic curets+cotton pellets+sterile saline ( CPS ) . In both groups , the intra-bony component was augmented with a natural bone mineral and covered with a collagen membrane . Clinical and radiographic parameters were recorded at baseline and after 6 months of non-submerged healing . RESULTS Two patients were lost during follow-up . At 6 months , ERL-treated sites failed to reveal higher reductions in mean bleeding on probing ( ERL : 47.8 ± 35.5 versus CPS : 55.0 ± 31.1 % ) and CAL values ( ERL : 1.5 ± 1.4 versus CPS : 2.2 ± 1.4 mm ) when compared with the CPS group . Both groups exhibited a comparable radiographic bone fill at the intra-bony defect component . CONCLUSION The study failed to demonstrate a significant impact of the method of surface DD on the clinical outcome following combined surgical therapy of advanced peri-implantitis lesions OBJECTIVES To investigate the impact of residual defect height ( RDH ) following guided bone regeneration ( GBR ) in dehiscence-type defects on the long-term stability of peri-implant health after a period of 4 years . MATERIAL AND METHODS The RDH values in dehiscence-type defects at titanium implants were clinical ly assessed after 4 months of submerged healing following augmentation using a natural bone mineral ( NBM ) and a r and omized application of either a cross-linked- ( VN ) or a native collagen membrane ( BG ) ( n=12 patients each ) . The RDH values were classified as absent ( 0 mm , control ; n=8 ) , minimal ( 1 mm , test 1 ; n=8 ) , or advanced
Output:
| Within the limitation of this systematic review , the application of grafting material s and barrier membranes result ed in greater PD reduction and RBF , but there is a lack of high- quality comparative studies to support this statement . |
MS213974 | ***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 Urinary tract infections ( UTI ) can cause acute morbidity and may result in severe problems , including hypertension and reduced renal function . Diagnosis of UTI is extremely important since prompt treatment may prevent damage . In the present study we compared the efficacy of oral cefixime to initial intramuscular ceftizoxime followed by cefixime for the treatment of UTI in children . Fifty-four children were studied . They were r and omized to receive either oral cefixime 8 mg/kg/day for 10 days or initial intramuscular ceftizoxime ( Cefızox ) 50 mg/kg twice a day for 2 days followed by oral cefixime for 8 days . Treatment groups were comparable regarding age , sex , clinical , and laboratory findings . Escherichia coli was isolated from 80 % of patients . Repeat urine cultures were sterile within 24 hours in all children . Cure rates were comparable in both groups ( 92 % vs 86 % at the end of treatment ) . No serious adverse effects were observed . We concluded that oral cefixime is a safe and effective alternative treatment Background . The st and ard recommendation for treatment of young , febrile children with urinary tract infection has been hospitalization for intravenous antimicrobials . The availability of potent , oral , third-generation cephalosporins as well as interest in cost containment and avoidance of nosocomial risks prompted evaluation of the safety and efficacy of outpatient therapy . Methods . In a multicenter , r and omized clinical trial , we evaluated the efficacy of oral versus initial intravenous therapy in 306 children 1 to 24 months old with fever and urinary tract infection , in terms of short-term clinical outcomes ( sterilization of the urine and defervescence ) and long-term morbidity ( incidence of reinfection and incidence and extent of renal scarring documented at 6 months by99mTc-dimercaptosuccinic acid renal scans ) . Children received either oral cefixime for 14 days ( double dose on day 1 ) or initial intravenous cefotaxime for 3 days followed by oral cefixime for 11 days . Results . Treatment groups were comparable regarding demographic , clinical , and laboratory characteristics . Bacteremia was present in 3.4 % of children treated orally and 5.3 % of children treated intravenously . Of the short-term outcomes , 1 ) repeat urine cultures were sterile within 24 hours in all children , and 2 ) mean time to defervescence was 25 and 24 hours for children treated orally and intravenously , respectively . Of the long-term outcomes , 1 ) symptomatic reinfections occurred in 4.6 % of children treated orally and 7.2 % of children treated intravenously , 2 ) renal scarring at 6 months was noted in 9.8 % children treated orally versus 7.2 % of children treated intravenously , and 3 ) mean extent of scarring was ∼8 % in both treatment groups . Mean costs were at least twofold higher for children treated intravenously ( $ 3577 vs $ 1473 ) compared with those treated orally . Conclusions . Oral cefixime can be recommended as a safe and effective treatment for children with fever and urinary tract infection . Use of cefixime will result in substantial reductions of health care expenditures Abstract . The aim of this study was to compare , in children with acute pyelonephritis , the efficacy of 7 days ’ ( group A ) and 3 days ’ ( group B ) intravenous antibiotics , both followed by an oral treatment . Children were r and omized after 3 days of intravenous treatment . Technetium-99 m dimercaptosuccinic acid ( DMSA ) scintigraphy was performed within the first days after admission and repeated 6 months later . Total or partial persistence of renal abnormalities on the 6-month DMSA scintigraphy was used as the endpoint of the study . Among the 92 children included in the study , 87 were followed for at least 6 months ( 43 in group A and 44 in group B ) and were eligible for analysis . Late DMSA was abnormal in 9 kidneys of group A and 12 kidneys of group B , representing respectively 24 % and 44 % of kidneys with abnormalities on the initial DMSA ( difference statistically not significant ) . When the patients were stratified according to the delay of treatment , the percentage of patients with sequelae in group A was comparable , whether the delay was less or more than 1 week . In group B , the percentage of patients with sequelae was significantly higher ( P<0.01 ) when the delay was more than 1 week Objective . To undertake population pharmacokinetic modeling and to determine the safety and efficacy of once daily ( OD ) gentamicin dosing in children with severe urinary tract infections ( UTI ) . Methods . An open , r and omized , controlled trial comparing OD with three times daily ( TD ) gentamicin dosing in hospitalized children ages 1 month to 12 years with UTI . Daily doses ( milligrams per kg per day ) of gentamicin in both groups were 7.5 ( < 5 years old ) , 6.0 ( 5 to 10 years old ) and 4.5 ( > 10 years old ) . Results . There were 179 children enrolled ( 90 OD , 89 TD ) . Baseline clinical characteristics and pathogens were similar , except that circulatory compromise and renal cortical scintigraphic defects were more common in the OD group . Median gentamicin treatment duration s were 3.0 ( OD ) and 2.7 ( TD ) days . Mean peak gentamicin concentrations were 17.3 ( OD ) vs. 6.4 ( TD ) mg/l ; 99 % of peak concentrations were > 7 mg/l in the OD group whereas 16 % of peak concentrations were < 5 mg/l in the TD group . Mean trough concentrations were 0.35 ( OD ) vs. 0.55 ( TD ) mg/l . In the OD group 4 % of trough concentrations were ≥2 mg/l , whereas in the TD group only 0.7 % were ≥2 mg/l . Age or prior elevated peak concentrations did not predict high trough concentrations . Population pharmacokinetic modeling of the data fitted a one-compartment model with first order elimination . There were no clinical or bacteriologic failures . The two disease-related complications were confined to the OD group . No nephro- or ototoxicity was identified . Conclusions . With age-appropriate dosing and measurement of serum trough concentrations before the second dose , OD gentamicin is safe and effective for the treatment of UTI requiring parenteral treatment in children aged 1 month to 12 years The efficacy and safety of netilmicin , 5 mg/kg of body weight once daily or 2 mg/kg thrice daily for 10 days , for the treatment of gram-negative pyelonephritis in children were compared in a prospect i ve , r and omized trial . Explicit criteria were used to define the site of infection , treatment outcome , and adverse effects . Netilmicin was given to 74 children once daily and to 70 children three times daily . At 1 week posttreatment , 73 ( 99 % ) of 74 children treated with netilmicin once daily and 70 ( 100 % ) of 70 children treated with netilmicin three times daily were cured . At 4 weeks posttreatment , no relapse was detected and the rate of reinfection was essentially identical in the two treatment groups . Peak serum netilmicin concentrations were higher in patients given the once-daily regimen , whereas a higher trough level was detected in patients given the three-times-daily regimen . Nephrotoxicity , which was defined as an increase in the serum creatinine level of greater than or equal to 0.3 mg/dl over the baseline , was rare ( 3 % ) and reversible and occurred regardless of the treatment regimen . Ototoxicity , which was assessed by pure-tone audiometry ( 250 to 8,000 Hz ) and brain stem-evoked response ( 6,000 Hz ) , occurred in 2 of 32 children who were evaluated . In these two children , who were given the once-daily regimen , wave V was not evokable monolaterally below 25 and 40 dB normal hearing level , respectively . Thus , it may be possible to treat childhood pyelonephritis with netilmicin once daily . However , this new approach needs to be confirmed in other studies Aim : To examine the safety and efficacy of once‐daily ( OD ) gentamicin treatment compared with conventional 8‐hourly dosing ( TDS ) for urinary tract infection ( UTI ) . Methods : This was a prospect i ve , r and omized , controlled trial of children 1 mo to 13 y of age with presumed UTI . Children were r and omly assigned to OD gentamicin 5 mg kg−1 d−1 or TDS gentamicin 6 mg kg−1 d−1 divided 8 hourly . Microbiological efficacy , nephrotoxicity , ototoxicity and renal scarring were assessed at the end of treatment . Results : 210 patients with presumed UTI were recruited , of whom 172 were analysable ( OD 84 , TDS 88 ) . The median age was 7 mo , 50 % were male and 74 % ( n= 127 ) of patients had pyelonephritis . The majority of infections were due to Escherichia coli ( n= 153 , 89 % ) , of which 9 ( 5.2 % ) were bacteraemic . Comparing the two groups , there was no significant difference in age , gender , duration of fever before admission , pyuria , nitrite positivity or initial total white blood cell count . All patients had negative urine cultures after 2–3 d of treatment , demonstrating 100 % microbiological efficacy . There was no difference between the two groups in terms of ototoxicity , nephrotoxicity , duration of gentamicin treatment or time to fever defervescence BACKGROUND Acute pyelonephritis often leaves children with permanent renal scarring . AIMS To compare the prevalence of scarring following initial treatment with antibiotics administered intravenously for 10 or three days . METHODS In a prospect i ve two centre trial , 220 patients aged 3 months to 16 years with positive urine culture and acute renal lesions on initial DMSA scintigraphy , were r and omly assigned to receive intravenous ceftriaxone ( 50 mg/kg once daily ) for 10 or three days , followed by oral cefixime ( 4 mg/kg twice daily ) to complete a 15 day course . After three months , scintigraphy was repeated in order to diagnose renal scars . RESULTS Renal scarring developed in 33 % of the 110 children in the 10 day intravenous group and 36 % of the 110 children in the three day group . Children older than 1 year had more renal scarring than infants ( 42 % ( 54/129 ) and 24 % ( 22/91 ) , respectively ) . After adjustment for age , sex , duration of fever before treatment , degree of inflammation , presence of vesicoureteric reflux , and the patients ' recruitment centres , there was no significant difference between the two treatments on renal scarring . During follow up , 15 children had recurrence of urinary infection with no significant difference between the two treatment groups . CONCLUSION In children with acute pyelonephritis , initial intravenous treatment for 10 days , compared with three days , does not significantly reduce the development of renal scarring Abstract To investigate the attitude of Belgian pediatricians toward the management and treatment of children with suspected acute pyelonephritis , a short letter was sent to all Belgian pediatricians ( 1200 ) . It contained a brief description of a clinical case strongly suggestive of acute pyelonephritis followed by a series of questions centered on complementary examinations to be performed , need of hospitalization and treatment . A total of 583 responses were received ( 49 % ) . In the acute phase , 99 % of pediatricians perform urine cultures , 87 % blood examinations , and 76 % renal ultrasound . Dimercaptosuccinate ( DMSA ) scintigraphy is performed during the acute phase by 37 % and during follow-up by 32 % of all pediatricians . A voiding cystogram is requested by 71 % . Ambulatory treatment is considered by 30 % of responders . Amoxicillin/clavulanic acid ( 44 % ) and trimethoprim/sulfonamide ( 22 % ) are the most frequently used oral antibiotics . Private pediatricians perform fewer examinations and more frequently consider ambulatory treatment of acute pyelonephritis , compared to pediatricians working in hospitals . Among Belgian pediatricians , attitudes toward the diagnosis and treatment of acute pyelonephritis are heterogeneous . This survey underlines the need for properly documented prospect i ve studies for the evaluation of different treatment modalities in childhood acute pyelonephritis Cefetamet pivoxil was investigated in an open , r and omized comparative study involving a total of 37 children with acute pyelonephritis , whose ages ranged from 2 to 14 years . The patients received either 10 mg/kg ( n = 18 ) or 20 mg/kg ( n = 8) cefetamet pivoxil twice daily , or 30–50 mg/kg amoxycillin/clavulanic acid three times daily ( n = 1
Output:
| These results suggest that children with acute pyelonephritis can be treated effectively with oral antibiotics ( cefixime , ceftibuten and amoxycillin/clavulanic acid ) or with short courses ( 2 to 4 days ) of IV therapy followed by oral therapy .
If IV therapy is chosen , single daily dosing with aminoglycosides is safe and effective . |
MS213975 | ***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 prophylactic administration of injectable tilmicosin for pneumonia in weaned beef calves was investigated in 1,806 animals . Comparisons were made among calves receiving an " on-arrival " injection of tilmicosin , calves receiving a single injection of long-acting oxytetracycline , and calves receiving no prophylaxis . Morbidity and mortality attributable to pneumonia , morbidity and mortality attributable to all causes , and case fatality were significantly lower in the group of calves that received tilmicosin , compared with calves that received long-acting oxytetracycline and calves that received no prophylactic antibiotic . Mean time to initial pneumonia treatment was significantly extended in calves that received prophylaxis , compared with those that received no antibiotic on arrival at the feedlot . Calves that received tilmicosin gained significantly more weight than calves that received oxytetracycline . Calves that were not treated for pneumonia during the trial period gained significantly more weight than did those calves that were treated for pneumonia regardless of experimental group . The majority of mortalities were attributable to fibrinous pneumonia ( 31/34 ) . Important bacterial isolates ( Pasteurella spp , Haemophilus somnus , Actinomyces pyogenes ) obtained at necropsy did not have resistance to tilmicosin in association with administration of tilmicosin as prophylaxis for pneumonia . However , bacterial resistance to trimethoprim/sulfonamide and to oxytetracycline were commonly found in these postmortem isolates The objectives of this study were to determine ( i ) whether an association exists between individual pharmacokinetic parameters and treatment outcome when feeder cattle were diagnosed with bovine respiratory disease ( BRD ) and treated with gamithromycin ( Zactran ( ® ) ) at the label dose and ( ii ) whether there was a stronger association between treatment outcome and gamithromycin concentration in plasma or in the pulmonary epithelial lining fluid ( PELF ) effect compartment . The study design was a prospect i ve , blinded , r and omized clinical trial utilizing three groups of 60 ( 362 - 592 lb ) steers/bulls r and omly allocated within origin to sham injection or gamithromycin mass medication . Cattle were evaluated daily for signs of BRD by a veterinarian blinded to treatment . Animals meeting the BRD case definition were enrolled and allocated to a sample collection scheme consisting of sample s for bacterial isolation ( bronchoalveolar lavage fluid and nasopharyngeal swabs ) and gamithromycin concentration determination ( PELF and plasma ) . Gamithromycin susceptibility of M. haemolytica ( n = 287 ) and P. multocida ( n = 257 ) were determined using broth microdilution with frozen panels containing gamithromycin at concentrations from 0.03 to 16 μg/mL. A two-compartment plasma pharmacokinetic model with an additional compartment for gamithromycin in PELF was developed using rich data sets from published and unpublished studies . The sparse data from our study were then fit to this model using nonlinear mixed effects modeling to estimate individual parameter values . The result ing parameter estimates were used to simulate full time-concentration profiles for each animal in this study . These profiles were analyzed using noncompartmental methods so that PK/PD indices ( AUC24 /MIC , AUC∞ /MIC , CMAX /MIC ) could be calculated for plasma and PELF ( also T > MIC ) for each individual . The calculated PK/PD indices were indicative that for both M. haemolytica and P. multocida a higher drug exposure in terms of concentration , and duration of exposure relative to the MIC of the target pathogen , was favorable to a successful case outcome . A significant association was found between treatment success and PELF AUC0 - 24 /MIC for P. multocida . The calves in this study demonstrated an increased clearance and volume of distribution in plasma as compared to the healthy calves in two previously published reports . Ultimately , the findings from this study indicate that higher PK/PD indices were predictive of positive treatment outcomes The conduct of r and omized controlled trials in livestock with production , health , and food-safety outcomes presents unique challenges that may not be adequately reported in trial reports . The objective of this project was to modify the CONSORT ( Consoli date d St and ards of Reporting Trials ) statement to reflect the unique aspects of reporting these livestock trials . A two-day consensus meeting was held on November 18 - 19 , 2008 in Chicago , IL , United States of America , to achieve the objective . Prior to the meeting , a Web-based survey was conducted to identify issues for discussion . The 24 attendees were biostatisticians , epidemiologists , food-safety research ers , livestock-production specialists , journal editors , assistant editors , and associate editors . Prior to the meeting , the attendees completed a Web-based survey indicating which CONSORT statement items may need to be modified to address unique issues for livestock trials . The consensus meeting result ed in the production of the REFLECT ( Reporting Guidelines For R and omized Control Trials ) statement for livestock and food safety ( LFS ) and 22-item checklist . Fourteen items were modified from the CONSORT checklist , and an additional sub-item was proposed to address challenge trials . The REFLECT statement proposes new terminology , more consistent with common usage in livestock production , to describe study subjects . Evidence was not always available to support modification to or inclusion of an item . The use of the REFLECT statement , which addresses issues unique to livestock trials , should improve the quality of reporting and design for trials reporting production , health , and food-safety outcomes Feedlot calves ( n = 3784 ) were systematic ally r and omized and allocated in a 2 × 2 factorial study to receive metaphylactic oxytetracycline ( OTC ) on arrival or no antimicrobial , as well as florfenicol once subcutaneously or twice intramuscularly ( 48 h apart ) if diagnosed with bovine respiratory disease ( BRD ) . Calves of different treatment groups were comingled and followed from placement to re-implantation ( ~100 days ) . Animals receiving OTC had a reduced risk of BRD , an increased risk of arthritis , and no significant differences in average daily gain , BRD relapse , overall mortality , or BRD mortality . There were no significant differences between treatment protocol s. Deep nasal swabs ( n = 233 ) taken at arrival ( n = 122 ) , treatment ( n = 77 ) , and swabs from lungs and joints at postmortem ( n = 34 ) were cultured for Mycoplasma bovis from 61 animals ill or dying of chronic pneumonia and arthritis and from 61 healthy calves . There was significant variation in diversity among isolates ( n = 51 ) between study years and different cattle . Metaphylaxis or antimicrobial treatment did not affect the diversity of isolates . Except for tilmicosin , isolates were largely susceptible to tested antimicrobials The efficacy of tulathromycin in the treatment ( phase 1 ) and prevention ( phase 2 ) of bovine respiratory disease ( BRD ) was evaluated on commercial farms in France , Germany , Italy , and Spain . In phase 1 , commingled cattle with clinical BRD were treated with tulathromycin ( n = 128 ) or florfenicol ( n = 125 ) on day 0 . Similar percentages of animals showed sustained clinical improvement at day 14 ( tulathromycin 83.3 % versus florfenicol 81.0 % ) and had not relapsed by day 60 ( tulathromycin 63.3 % versus florfenicol 58.4 % ) . In phase 2 , healthy in-contact cattle were treated with tulathromycin ( n = 492 ) , tilmicosin ( n = 494 ) , or saline ( n = 265 ) on day 0 . Significantly more ( P = .0001 ) tulathromycin-treated cattle remained healthy to day 14 ( 92.4 % ) than tilmicosin-treated ( 83.7 % ) or saline-treated ( 63.7 % ) cattle , and this was maintained through day 60 ( tulathromycin 85.4 % versus tilmicosin 75.1 % and saline 56.2 % ) . Tulathromycin was highly effective in the treatment and prevention of BRD OBJECTIVE To determine effects of vaccination prior to transit and prophylactic administration of florfenicol at time of arrival at a feedyard on health of cattle and colonization of the nasopharynx by Mannheimia haemolytica ( MH ) . ANIMALS 121 steers from Tennessee and 84 steers from New Mexico . PROCEDURE Half of the steers were vaccinated before transport to a feedyard . Steers from Tennessee were vaccinated with MH bacterin-toxoid , and steers from New Mexico were vaccinated intranasally with modified-live leukotoxin-deficient MH . Half of the vaccinates and nonvaccinates were r and omly selected to receive florfenicol on arrival at the feedyard . Steers were observed daily for respiratory tract disease ( RTD ) . RESULTS Administration of florfenicol at time of arrival reduced the incidence of RTD , delayed the interval before onset of RTD , and reduced the incidence of MH colonization of the nasopharynx for at least 4 days , but vaccination did not have any effect . Vaccination elicited an increase in serum antibody titers to MH . Administration of florfenicol at time of arrival reduced the development of serum antibody titers in intranasally vaccinated steers and both groups of nonvaccinated steers , but intranasal vaccination did not affect colonization by wild-type MH . CONCLUSIONS AND CLINICAL RELEVANCE Administration of florfenicol at time of arrival decreased the incidence of MH organisms in the nasopharynx and delayed the onset of RTD . Prophylactic use of suitable antibiotics is likely to reduce the incidence of acute RTD in calves for several days after arrival at feedyards , which is the period when they are most susceptible to infectious organisms The effectiveness of a feed-additive antimicrobial combination for improving feedlot performance and health was tested using 4325 high-risk feeder calves r and omly allocated to a control group or an experimental group . The experimental group received the conventional ration plus a feed additive containing 700 mg per head/day of chlortetracycline and sulfamethazine from arrival at the feedlot to day 56 of the feeding period . The inclusion of the feed additive to the ration significantly improved average daily gain for days 0 - 28 ( P = 0.0163 ) and 0 - 56 ( P = 0.0001 ) , and the feed conversion for days 0 - 28 ( P = 0.0061 ) and 0 - 56 ( P = 0.0004 ) . Additionally , the use of the feed additive significantly reduced the rate of bovine respiratory disease morbidity for days 0 - 28 ( P = 0.0014 ) and 0 - 56 ( P = 0.0001 ) , the rate of relapses and mortality for days 0 - 56 ( P = 0.0151 and P = 0.0209 , respectively ) , and the rate of animals diagnosed with chronic respiratory disease for days 0 - 28 and 0 - 56 ( P = 0.0009 and P = 0.0002 , respectively ) . Performance and health improvements produced by the use of the feed additive were cost-effective Three trials were conducted to evaluate the use of tilmicosin phosphate ( Micotil ) as a prophylactic medication for newly received , stressed beef cattle . In Trial 1 , 57 beef calves ( average initial BW = 170 kg ) were shipped to the research feedlot from Tennessee and either given no antibiotic at processing or treated with Micotil at 10 mg of tilmicosin phosphate/kg of BW . During a 28-d receiving period , treatment at processing with Micotil did not affect daily gain ( P < .17 ) or DMI ( P < .22 ) compared to control calves . Prophylactic treatment with Micotil decreased ( P < .01 ) the percentage of calves treated for symptoms of bovine respiratory disease from 46.4 to 0 % . In Trial 2 , 117 calves ( average initial BW = 191 kg ) were shipped from Tennessee and allotted r and omly to the same two treatments as in Trial 1 . All calves grazed a 24-ha pasture of irrigated winter wheat during the 28-d receiving period . Treatment of calves with Micotil at the time of arrival processing did not affect ( P > .50 ) daily gain during the trial ; however , as in Trial 1 , mass treatment with Micotil decreased ( P < .01 ) the percentage of calves treated for respiratory disease from 32.8 % to 12.1 % . In Trial 3 , two truckloads of beef calves ( 183 total ; average initial BW = 232 kg ) shipped from Tennessee were allotted r and omly to the same two treatments used in Trials 1 and 2 or to a third treatment that consisted of administration of Micotil at arrival processing if the rectal temperature of the calf was > or = 39.7 degrees C. ( ABSTRACT TRUNCATED AT 250 WORDS The objectives of this study were to 1 ) quantify effects of metaphylactic treatment for bovine respiratory disease ( BRD ) on growth performance ,
Output:
| Antimicrobial prophylaxis and metaphylaxis demonstrated moderate , yet highly variable relative risk reductions in BRD morbidity .
These were dependent on the antimicrobial classes used , dependent on metaphylaxis definition , BRD attack rates and duration of the RCTs .
Best relative risk reductions were from broad‐spectrum critically important antimicrobials , or combinations .
BRD prophylaxis/metaphylaxis represents major antimicrobial consumption for highly variable short‐term gains in absolute risk reduction of morbidity/mortality . |
MS213976 | ***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 We assessed the efficacy and safety of programmed cell death 1 ( PD-1 ) inhibition with pembrolizumab in patients with advanced non-small-cell lung cancer enrolled in a phase 1 study . We also sought to define and vali date an expression level of the PD-1 lig and 1 ( PD-L1 ) that is associated with the likelihood of clinical benefit . METHODS We assigned 495 patients receiving pembrolizumab ( at a dose of either 2 mg or 10 mg per kilogram of body weight every 3 weeks or 10 mg per kilogram every 2 weeks ) to either a training group ( 182 patients ) or a validation group ( 313 patients ) . We assessed PD-L1 expression in tumor sample s using immunohistochemical analysis , with results reported as the percentage of neoplastic cells with staining for membranous PD-L1 ( proportion score ) . Response was assessed every 9 weeks by central review . RESULTS Common side effects that were attributed to pembrolizumab were fatigue , pruritus , and decreased appetite , with no clear difference according to dose or schedule . Among all the patients , the objective response rate was 19.4 % , and the median duration of response was 12.5 months . The median duration of progression-free survival was 3.7 months , and the median duration of overall survival was 12.0 months . PD-L1 expression in at least 50 % of tumor cells was selected as the cutoff from the training group . Among patients with a proportion score of at least 50 % in the validation group , the response rate was 45.2 % . Among all the patients with a proportion score of at least 50 % , median progression-free survival was 6.3 months ; median overall survival was not reached . CONCLUSIONS Pembrolizumab had an acceptable side-effect profile and showed antitumor activity in patients with advanced non-small-cell lung cancer . PD-L1 expression in at least 50 % of tumor cells correlated with improved efficacy of pembrolizumab . ( Funded by Merck ; KEYNOTE-001 Clinical Trials.gov number , NCT01295827 . ) Purpose : Although clinical studies have shown promise for targeting programmed cell death protein-1 ( PD-1 ) and lig and ( PD-L1 ) signaling in non – small cell lung cancer ( NSCLC ) , the factors that predict which subtype patients will be responsive to checkpoint blockade are not fully understood . Experimental Design : We performed an integrated analysis on the multiple-dimensional data types including genomic , transcriptomic , proteomic , and clinical data from cohorts of lung adenocarcinoma public ( discovery set ) and internal ( validation set ) data base and immunotherapeutic patients . Gene set enrichment analysis ( GSEA ) was used to determine potentially relevant gene expression signatures between specific subgroups . Results : We observed that TP53 mutation significantly increased expression of immune checkpoints and activated T-effector and interferon-γ signature . More importantly , the TP53/KRAS comutated subgroup manifested exclusive increased expression of PD-L1 and a highest proportion of PD-L1+/CD8A+ . Meanwhile , TP53- or KRAS-mutated tumors showed prominently increased mutation burden and specifically enriched in the transversion-high ( TH ) cohort . Further analysis focused on the potential molecular mechanism revealed that TP53 or KRAS mutation altered a group of genes involved in cell-cycle regulating , DNA replication and damage repair . Finally , immunotherapeutic analysis from public clinical trial and prospect i ve observation in our center were further confirmed that TP53 or KRAS mutation patients , especially those with co-occurring TP53/KRAS mutations , showed remarkable clinical benefit to PD-1 inhibitors . Conclusions : This work provides evidence that TP53 and KRAS mutation in lung adenocarcinoma may be served as a pair of potential predictive factors in guiding anti – PD-1/PD-L1 immunotherapy . Clin Cancer Res ; 23(12 ) ; 3012–24 . © 2016 AACR BACKGROUND Atezolizumab is a humanised antiprogrammed death-lig and 1 ( PD-L1 ) monoclonal antibody that inhibits PD-L1 and programmed death-1 ( PD-1 ) and PD-L1 and B7 - 1 interactions , reinvigorating anticancer immunity . We assessed its efficacy and safety versus docetaxel in previously treated patients with non-small-cell lung cancer . METHODS We did a r and omised , open-label , phase 3 trial ( OAK ) in 194 academic or community oncology centres in 31 countries . We enrolled patients who had squamous or non-squamous non-small-cell lung cancer , were 18 years or older , had measurable disease per Response Evaluation Criteria in Solid Tumors , and had an Eastern Cooperative Oncology Group performance status of 0 or 1 . Patients had received one to two previous cytotoxic chemotherapy regimens ( one or more platinum based combination therapies ) for stage IIIB or IV non-small-cell lung cancer . Patients with a history of autoimmune disease and those who had received previous treatments with docetaxel , CD137 agonists , anti-CTLA4 , or therapies targeting the PD-L1 and PD-1 pathway were excluded . Patients were r and omly assigned ( 1:1 ) to intravenously receive either atezolizumab 1200 mg or docetaxel 75 mg/m2 every 3 weeks by permuted block r and omisation ( block size of eight ) via an interactive voice or web response system . Co primary endpoints were overall survival in the intention-to-treat ( ITT ) and PD-L1-expression population TC1/2/3 or IC1/2/3 ( ≥1 % PD-L1 on tumour cells or tumour-infiltrating immune cells ) . The primary efficacy analysis was done in the first 850 of 1225 enrolled patients . This study is registered with Clinical Trials.gov , number NCT02008227 . FINDINGS Between March 11 , 2014 , and April 29 , 2015 , 1225 patients were recruited . In the primary population , 425 patients were r and omly assigned to receive atezolizumab and 425 patients were assigned to receive docetaxel . Overall survival was significantly longer with atezolizumab in the ITT and PD-L1-expression population s. In the ITT population , overall survival was improved with atezolizumab compared with docetaxel ( median overall survival was 13·8 months [ 95 % CI 11·8 - 15·7 ] vs 9·6 months [ 8·6 - 11·2 ] ; hazard ratio [ HR ] 0·73 [ 95 % CI 0·62 - 0·87 ] , p=0·0003 ) . Overall survival in the TC1/2/3 or IC1/2/3 population was improved with atezolizumab ( n=241 ) compared with docetaxel ( n=222 ; median overall survival was 15·7 months [ 95 % CI 12·6 - 18·0 ] with atezolizumab vs 10·3 months [ 8·8 - 12·0 ] with docetaxel ; HR 0·74 [ 95 % CI 0·58 - 0·93 ] ; p=0·0102 ) . Patients in the PD-L1 low or undetectable subgroup ( TC0 and IC0 ) also had improved survival with atezolizumab ( median overall survival 12·6 months vs 8·9 months ; HR 0·75 [ 95 % CI 0·59 - 0·96 ] ) . Overall survival improvement was similar in patients with squamous ( HR 0·73 [ 95 % CI 0·54 - 0·98 ] ; n=112 in the atezolizumab group and n=110 in the docetaxel group ) or non-squamous ( 0·73 [ 0·60 - 0·89 ] ; n=313 and n=315 ) histology . Fewer patients had treatment-related grade 3 or 4 adverse events with atezolizumab ( 90 [ 15 % ] of 609 patients ) versus docetaxel ( 247 [ 43 % ] of 578 patients ) . One treatment-related death from a respiratory tract infection was reported in the docetaxel group . INTERPRETATION To our knowledge , OAK is the first r and omised phase 3 study to report results of a PD-L1-targeted therapy , with atezolizumab treatment result ing in a clinical ly relevant improvement of overall survival versus docetaxel in previously treated non-small-cell lung cancer , regardless of PD-L1 expression or histology , with a favourable safety profile . FUNDING F. Hoffmann-La Roche Ltd , Genentech , The development of human cancer is a multistep process characterized by the accumulation of genetic and epigenetic alterations that drive or reflect tumour progression . These changes distinguish cancer cells from their normal counterparts , allowing tumours to be recognized as foreign by the immune system . However , tumours are rarely rejected spontaneously , reflecting their ability to maintain an immunosuppressive microenvironment . Programmed death-lig and 1 ( PD-L1 ; also called B7-H1 or CD274 ) , which is expressed on many cancer and immune cells , plays an important part in blocking the ‘ cancer immunity cycle ’ by binding programmed death-1 ( PD-1 ) and B7.1 ( CD80 ) , both of which are negative regulators of T-lymphocyte activation . Binding of PD-L1 to its receptors suppresses T-cell migration , proliferation and secretion of cytotoxic mediators , and restricts tumour cell killing . The PD-L1–PD-1 axis protects the host from overactive T-effector cells not only in cancer but also during microbial infections . Blocking PD-L1 should therefore enhance anticancer immunity , but little is known about predictive factors of efficacy . This study was design ed to evaluate the safety , activity and biomarkers of PD-L1 inhibition using the engineered humanized antibody MPDL3280A . Here we show that across multiple cancer types , responses ( as evaluated by Response Evaluation Criteria in Solid Tumours , version 1.1 ) were observed in patients with tumours expressing high levels of PD-L1 , especially when PD-L1 was expressed by tumour-infiltrating immune cells . Furthermore , responses were associated with T-helper type 1 ( TH1 ) gene expression , CTLA4 expression and the absence of fractalkine ( CX3CL1 ) in baseline tumour specimens . Together , these data suggest that MPDL3280A is most effective in patients in which pre-existing immunity is suppressed by PD-L1 , and is re-invigorated on antibody treatment 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
Output:
| Conclusion and Relevance Checkpoint inhibitors , compared with docetaxel , are associated with significantly prolong overall survival in second-line therapy in NSCLC . |
MS213977 | ***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: INTRODUCTION Self-ligating orthodontic brackets rely on clips , rather than ligatures , to hold the archwire in place . It is unknown whether replacing ligatures with clips affects the adherence of Streptococcus mutans . The aim of this research was to evaluate whether self-ligating brackets have an advantage over conventional brackets as determined by the adherence of S mutans . METHODS The sample consisted of 50 esthetic brackets , divided into 3 experimental groups and 2 control groups of 10 brackets each . Two experimental groups were active self-ligating brackets ( QuicKlear ; Forestadent , Pforzheim , Germany ; and In-Ovation C ; Dentsply GAC , Bohemia , NY ) ; the other was a passive self-ligating bracket ( Damon 3 ; Ormco , Glendora , Calif ) . The 2 control groups were conventional brackets ( Mystique ; Dentsply GAC ; and Clarity ; 3 M Unitek , Monrovia , Calif ) . The brackets were r and omly bonded to the canines , first and second premolars , and first and second molars in the m and ibular left hemiarch of 10 male participants . Biofilm was collected from the tooth surfaces before bonding and from the brackets on day 21 and placed in Petri dishes containing Mitis salivarius agar . The brackets were removed on day 28 and examined by using scanning electron microscopy . Statistical analysis , analysis of variance , and the Tukey correction with a P value of 0.05 were used . RESULTS The greatest numbers of colonies were found in an active self-ligating bracket group ( In-Ovation C ) , and the fewest colonies were in a conventional bracket group ( Clarity ) . The largest colonies formed on active self-ligating brackets . In the slot , the greatest formation was in a control group ( Mystique ) . CONCLUSIONS Self-ligating esthetic brackets do not promote greater or lesser S mutans colonization when compared with conventional brackets . Differences were found to be related to the material composition of the bracket INTRODUCTION Enamel decalcification is a common problem in orthodontics . The objectives of this r and omized clinical study were to enumerate and compare plaque bacteria surrounding 2 bracket types , self-ligating ( SL ) vs elastomeric ligating ( E ) , and to determine whether adenosine triphosphate (ATP)-driven bioluminescence could be used for rapid assessment of bacterial load in plaque . METHODS Patients ( ages , 11 - 17 years ) were bonded with SL and E brackets in 14 maxillary and 12 m and ibular arches by using a split-mouth design . Recall visits were at 1 and 5 weeks after bonding . Plaque specimens were assayed for oral bacteria and subjected to ATP-driven bioluminescence determinations with a luciferin-based assay . RESULTS In most patients , teeth bonded with SL attachments had fewer bacteria in plaque than did teeth bonded with E brackets . At 1 and 5 weeks after bonding , the means for SL vs E brackets were statistically lower for total bacteria and oral streptococci ( P < 0.05 ) . ATP bioluminescence values were statistically correlated to the total oral bacteria and oral streptococci , with correlation coefficients of 0.895 and 0.843 , respectively . CONCLUSIONS SL appliances promote reduced retention of oral bacteria , and ATP bioluminescence might be a useful tool in the rapid quantification of bacterial load and the assessment of oral hygiene during orthodontic treatment 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 Abstract . Aim : The purpose of the present study was to investigate the composition and to assess the microhardness and structure of asreceived , retrieved , and recycled stainless steel brackets . Material s and Methods : New , used , and recycled br and - , slot size- , and prescription-matched appliances were subjected to scanning electron microscopy ( SEM ) , energy dispersive ( EDS ) electron probe micro analysis , metallographic analysis , and Vickers microhardness testing . Elemental analysis was performed on r and omly selected bulk material base and wing areas . Basic metal content and microhardness results were statistically analyzed using a two-way ANOVA and the Tukey test , with treatment ( asreceived , retrieved , and recycled ) and bracket region ( base , wing ) serving as discriminating variables ( α = 0.05 ) . Results : The results showed that there was no alteration in the bulk composition of the brackets among the three conditions . In contrast , differences were noted between bracket base and wing with respect to elemental composition among all groups , implying that the base and wings were manufactured from different alloys . The metallographic etching identified no difference in grain structure between the bracket base and wing components for all groups , regardless of treatment . Vickers microhardness demonstrated significant differences in hardness between base and wing for all groups and between recycled and retrieved states for the wing component . Zusammenfassung . Ziel : Das Ziel dieser Studie war die Untersuchung der Zusammensetzung und die Bestimmung der Mikrohärte und Struktur von fabrikneuen , gebrauchten und recycelten Stahlbrackets . Material und Method en : Neue , gebrauchte und recycelte Brackets , die von einem Hersteller stammten und in Slotgröße und Vorprogrammierung übereinstimmten , wurden der Rasterelektronenmikroskopie ( SEM ) , der energiedispersiven Röntgenmikroanalyse ( EDS ) , der metallographischen Analyse und dem Vickers-Mikrohärtetest unterzogen . Eine elementare Analyse wurde an zufällig ausgewählten Bracketbasen und -flügeln durchgeführt . Die Ergebnisse der elementaren metallischen Best and teile und der Mikrohärte wurden statistisch mithilfe einer zweifaktoriellen Varianzanalyse ( ANOVA ) und eines Tukey-Tests untersucht , wobei die Vorbeh and lung ( fabrikneu , gebraucht und recycelt ) und die Bracketregion ( Basis , Flügel ) als diskriminierende Variablen dienten ( α = 0,05 ) . Ergebnisse : Die Ergebnisse zeigten , dass i m Bereich der Bracketbasen keine Veränderungen zwischen den drei Gruppen festzustellen waren . Es wurden hingegen Unterschiede zwischen Bracketbasis und -flügel hinsichtlich der elementaren Zusammensetzung in allen Gruppen beobachtet . Dies impliziert , dass Basen und Flügel aus verschiedenen Legierungen hergestellt wurden . Die metallographische Ätzung ergab bei allen Gruppen keinen Unterschied in der Kornstruktur der Bracketbasen und -flügel , ungeachtet ihrer Vorbeh and lung . Die Mikrohärte nach Vickers zeigte bei allen Gruppen signifikante Unterschiede bezüglich der Härte zwischen Basis und Flügel sowie zwischen recycelten und gebrauchten Flügelkomponenten
Output:
| Friction force increased after intraoral aging in most of the studies .
However , there is lack of good quality evidence in this research area .
Conclusions Brackets present increased surface roughness after clinical use , and consequently increased coefficient of friction ( COF ) and Friction Force . |
MS213978 | ***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: Ketoprofen , 25 , 50 , and 100 mg , was compared with 90 mg codeine and placebo for relief of pain due to removal of impacted third molar teeth . Treatment was self-administered as a single oral dose under double-blind conditions in five parallel groups established by a r and om code in healthy young adults . Based on 129 patient evaluations of pain experience and pain relief , ketoprofen was shown to have a more rapid onset and longer duration of action than codeine . In the derived variables of SPID ( Sum of Pain Intensity Differences ) and TOPAR ( Total Pain Relief ) , all three doses of ketoprofen , with no dose-related differences among them , were found to provide statistically superior analgesia to codeine and placebo . All five treatments were associated with some adverse reactions Summary The efficacy and safety of ciramadol ( Cir ) as an analgesic in relieving moderate to severe pain after oral surgery has been studied in 79 patients r and omly assigned to receive single oral doses of Cir 15 , 30 or 60 mg , codeine 60 mg or placebo . During the 6-hour observation period , the three ciramadol-treated groups indicated greater pain relief than the codeine 60 mg or placebo groups . In general , Cir 60 mg was significantly more effective than codeine 60 mg , and all doses of Cir were superior to placebo . The proportion of patients in each Cir group reporting adverse experiences was significantly higher than in either the placebo or codeine groups . The experimental system proved very effective in demonstrating analgesic potency of Cir . The very high incidence of side-effects in the three ciramadol-treated groups makes it unfit for further clinical use in ambulant patients Meclofenamate sodium , a nonsteroidal anti-inflammatory drug with proven analgesic effects , was compared at two dose levels ( 200 mg and 100 mg ) with codeine ( 60 mg ) and placebo in a double-blind , r and omized study of 327 women experiencing episiotomy pain after normal delivery . Meclofenamate sodium at either dose was significantly better than codeine or placebo in reducing pain intensity and increasing pain relief , and it had a longer duration of action . Adverse effects were minimal , and their frequency did not differ significantly among treatment groups . Meclofenamate sodium appears to be as safe as and more effective than codeine for the management of episiotomy pain 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 Tramadol hydrochloride is a novel , central ly acting analgesic with two complementary mechanisms of action : opioid and aminergic . Relative to codeine , tramadol has similar analgesic properties but may have fewer constipating , euphoric , and respiratory depressant effects . A two-center r and omized double-blind controlled clinical trial was performed to assess the analgesic efficacy and reported side effects of tramadol 100 mg , tramadol 50 mg , codeine 60 mg , aspirin ( ASA ) 650 mg with codeine 60 mg , and placebo . Using a third molar extraction pain model , 200 healthy subjects were enrolled in a 6-hour evaluation after a single dose of drug . Of the 200 patients enrolled , seven provided incomplete efficacy data or discontinued prematurely and one was lost to follow-up . Using st and ard measures of analgesia , including total pain relief score ( TOTPAR ) , maximum pain relief score ( MaxPAR ) , sum of pain intensity difference scores ( SPID ) , peak pain intensity difference ( Peak PID ) , remedication , and global evaluations , all active treatments were found to be numerically superior to placebo . ASA/codeine was found to be statistically superior to placebo for all measures of efficacy . Tramadol 100 mg was statistically superior to placebo for TOTPAR , SPID , and time of remedication , whereas tramadol 50 mg was statistically superior to placebo onlyfor remedication time . Codeine was not found to be statistically superior to placebo for any efficacy measure . A greater TOTPAR response compared with all other active measures was seen for ASA/codeine during the first 3 hours of study . The 6-hour TOTPAR scores for the tramadol groups and ASA/ codeine group were not significantly different . Gastrointestinal side effects ( nausea , dysphagia , vomiting ) were reported more frequently with tramadol 100 mg , ASA/ codeine , and codeine 60 mg than with placebo In a double‐blind , r and omized , single‐dose trial the analgesic contribution of acetaminophen , 1000 mg , and codeine , 60 mg , was determined . The study was a 2 × 2 factorial experiment in which 120 patients suffering from pain as a result of oral surgery rated their pain intensity and pain relief for up to 5 hours after a single dose of one of : 1000 mg acetaminophen , 60 mg codeine , 1000 mg acetaminophen plus 60 mg codeine , or placebo . The factorial analysis showed that both 1000 mg acetaminophen and 60 mg codeine made a statistically significant ( P < 0.05 ) contribution to the analgesic effectiveness of the combination on all measures of efficacy ( sum of pain intensity differences , largest pain intensity difference , total pain relief , largest pain relief , and time to remedication ) . The incidence of adverse effects did not appear to differ among the treatments , including placebo & 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 To evaluate the analgesic efficacy of orally administered 50 mg propiram fumarate , 650 mg aspirin , 60 mg codeine phosphate , and placebo in acute post-impaction dental pain , 159 patients with moderate or severe pain were r and omly allocated to the four treatments in this single-dose double-blind , stratified , parallel-group study . A research nurse question ed the patients at 1/2 hour and hourly for 6 hours after medicating . A st and ard format was used to question subjects about their pain intensity and relief from the starting pain . Propiram , 50 mg , produced a level of analgesia approaching that of 650 mg aspirin in peak effect , total effect , and duration of action and was statistically superior to 60 mg codeine and placebo for every measure of analgesic efficacy . Several mild adverse effects were observed ; however , they appeared to be evenly distributed among the active treatments In a double-blind study , 198 out patients with pain after oral surgery were r and omly assigned to treatment with a single oral dose of naproxen sodium 550 mg , codeine sulfate 60 mg , a combination of naproxen sodium 550 mg with codeine sulfate 60 mg , aspirin 650 mg or placebo . Using a self-rating record , subjects rated their pain and its relief hourly for 12 hours after medication . Orthogonal contrasts for the four treatments making up the factorial component showed that the naproxen effect was significant for every measurement of total and peak analgesia ; the codeine effect was significant for total and peak pain relief and patients ' overall evaluation . The naproxen-codeine interaction was not statistically significant for any measure , which suggests that the analgesic effect of the combination represents the additive effect of its constituents . Based on pairwise comparisons , aspirin was significantly superior to placebo for most measures of effect , naproxen was significantly superior to both aspirin and codeine for all measures and the combination was significantly superior to naproxen for patients ' overall evaluation . No more patients experienced adverse effects with aspirin or naproxen than with placebo , but significantly more patients receiving the codeine-containing treatments experienced adverse effects than those receiving aspirin and naproxen 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 The purpose of this study was to evaluate the contribution of endogenous opiates to the analgesic response after treatment with placebo , codeine , and ibuprofen after oral surgery . Eighty-one patients undergoing complicated dental extraction s were pretreated with either a placebo or the narcotic antagonist naltrexone 50 mg , 30 minutes before surgery . After surgery , patients self administered one of three possible postsurgical medications , which included placebo , codeine 60 mg , and ibuprofen 400 mg , when their pain reached a moderate or severe intensity . The study was double-blind with the three postsurgical treatments being r and omly allocated within each presurgical treatment block . Pain intensity , pain relief , pain half gone , and overall evaluations were assessed for up to 6 hours . Ibuprofen was significantly more efficacious ( p < .05 ) than codeine or placebo for most analgesic measures . The administration of naltrexone before surgery reduced the analgesic response to both placebo and codeine . Pretreatment with naltrexone did not diminish the peak analgesic response to ibuprofen , but surprisingly prolonged ( p < .05 ) the duration of its action . The results suggest that a blockade of endogenous opiates by naltrexone diminished the placebo response , but that naltrexone may prolong ibuprofen analgesia by some unknown mechanism & 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
Output:
| More participants experienced adverse events with codeine 60 mg than placebo ; the difference was not significant and none were serious .
Single dose codeine 60 mg provides good analgesia to few individuals , and does not compare favourably with commonly used alternatives such as paracetamol , NSAIDs and their combinations with codeine , especially after dental surgery ; the large difference between dental and other surgery was unexpected . |
MS213979 | ***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: & NA ; The current analysis compares changes in pain with changes in function and health status in individuals with painful diabetic peripheral neuropathy ( DPN ) . The post hoc analysis is based on a 12 week , multinational , placebo‐controlled trial of pregabalin in which 401 patients were r and omized to treatment . Study measures included the Brief Pain Inventory short‐form ( BPI‐sf ) , EQ‐5D and other patient‐reported outcomes . Cutpoints were derived on the BPI‐sf 0–10 average pain numeric rating scale [ NRS ] to classify pain grade s of “ mild ” ( 1–3 ) , moderate ( 4–6 ) and severe ( 7–10 ) , adjusting for geographical regions where data were collected . Two different metrics were used to classify the importance of change in pain severity from baseline to 12 weeks : changes in pain severity grade s ( defined by cutpoint categories ) and percent reduction in the NRS ( categories ranging from 0–9 % to ≥50 % ) . An improvement in one pain grade or a ≥30 % reduction in the NRS served as determinants of a clinical ly important difference . Patients with a one‐ grade reduction in pain severity , either from “ severe‐to‐moderate ” or “ moderate‐to‐mild , ” had a 3‐point improvement the BPI‐sf Pain Interference Index ( PII ; a composite measure of function ) ; a reduction from “ severe‐to‐mild ” pain corresponded to a 6‐point improvement in the PII . Similarly , a reduction in the NRS of ≥30 % and ≥50 % corresponded to a 3‐point and a 5‐point improvement in the PII , respectively . Changes in pain were also associated with changes in health status . Results suggest that patients whose pain is not reduced to a mild level of severity can still experience clinical ly important changes in function and health status OBJECTIVES ( 1 ) To assess the feasibility and tolerability of the therapeutic transdermal fentanyl system ( TTS-fentanyl ) by using a clinical protocol developed for children with cancer pain . ( 2 ) To estimate the pediatric pharmacokinetic parameters of TTS-fentanyl . METHODS The drug was administered in open-label fashion ; and measures of analgesia , side effects , and skin changes were obtained for a minimum of 2 doses ( 6 treatment days ) . Blood specimens were analyzed for plasma fentanyl concentrations . The pharmacokinetics of TTS-fentanyl were estimated by using a mixed effect modeling approach . RESULTS Treatment was well tolerated . Ten of the 11 patients who completed the 2 doses continued treatment with TTS-fentanyl . The duration of treatment ranged from 6 to 275 days . The time to reach peak plasma concentration ranged from 18 hours to > 66 hours in patients receiving the 25 microg/h patch . Compared with published pharmacokinetic data from adults , the mean clearance and volume of distribution of transdermal fentanyl were the same , but the variability was less . CONCLUSIONS Treatment of children with TTS-fentanyl is feasible and well tolerated and yields fentanyl pharmacokinetic parameter estimates similar to those for adults . A larger study is required to confirm these findings and further test the clinical protocol & NA ; Chronic pain is associated with a range of other problems , including disturbed sleep , depression , anxiety , fatigue , reduced quality of life , and an inability to work or socialise . We investigated whether good symptom control of pain ( using definitions of moderate and substantial benefit ) is associated with improvement in other symptoms . Individual patient data from four r and omised trials in fibromyalgia ( 2575 patients ) lasting 8–14 weeks were used to calculate percentage pain reduction for each completing patient ( 1858 ) , divided into one of five groups according to pain reduction , irrespective of treatment : substantial benefit – ≥50 % pain reduction ; moderate – 30 % to < 50 % ; minimal – 15 % to < 30 % ; marginal – 0 % to < 15 % ; worse – < 0 % ( increased pain intensity ) . We then calculated change from baseline to end of trial for measures of fatigue , function , sleep , depression , anxiety , ability to work , general health status , and quality ‐adjusted life year ( QALY ) gain over a 12‐month period . Substantial and moderate pain intensity reductions were associated with statistically significant reduction from baseline by end of trial in all measures , with values by trial end at or approaching normative values . Substantial pain intensity reduction result ed in 0.11 QALYs gained , and moderate pain intensity reduction in 0.07 QALYs gained over a 12‐month period . Substantial and moderate pain intensity reduction predicts broad beneficial outcomes and improved quality of life that do not occur without pain relief . Pain intensity reduction is a simple and effective predictor of which patients should continue treatment , and which should discontinue and try an alternative therapy The World Health Organization ( WHO ) guidelines for the treatment of cancer pain recommend nonopioid analgesics as first-line therapy , so-called " weak " analgesics combined with nonopioid analgesics as second-line therapy , and so-called " strong " opioids ( with nonopioid analgesics ) only as third-line therapy . However , these guidelines can be question ed with regard to the extent of efficacy as well as the rationale for not using strong opioids as first-line treatment , especially in terminal cancer patients . The purpose of this r and omized study was to prospect ively compare the efficacy and tolerability of strong opioids as first-line agents with the recommendations of the WHO in terminal cancer patients . One hundred patients with mild-moderate pain were r and omized to treatment according to WHO guidelines or to treatment with strong opioids . Evaluated outcomes included pain intensity , need for change in therapy , quality of life , Karnofsky Performance Status , general condition of the patient , and adverse events . No between-treatment differences were observed for changes in quality of life or performance status , but patients started on strong opioids had significantly better pain relief than patients treated according to WHO guidelines ( P=0.041 ) . Additionally , patients started on strong opioids required significantly fewer changes in therapy , had greater reduction in pain when a change was initiated , and reported greater satisfaction with treatment than the comparator group ( P=0.041 ) . Strong opioids were safe and well-tolerated , with no development of tolerance or serious adverse events . These data suggest the utility of strong opioids for first-line treatment of pain in patients with terminal cancer
Output:
| No conclusions can be drawn about efficacy or harm in the use of opioids to treat cancer-related pain in children and adolescents .
As a result , there is no RCT evidence to support or refute the use of opioids to treat cancer-related pain in children and adolescents |
MS213980 | ***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 The prevalence and risk factors for recurrent instability and functional impairment following a primary glenohumeral dislocation remain poorly defined in younger patients . We performed a prospect i ve cohort study to evaluate these outcomes . We also aim ed to produce guidelines for the design of future clinical trials , assessing the efficacy of interventions design ed to improve the outcome after a primary dislocation . METHODS We performed a prospect i ve cohort study of 252 patients ranging from fifteen to thirty-five years old who sustained an anterior glenohumeral dislocation and were treated with sling immobilization , followed by a physical therapy program . Patients received regular clinical follow-up to assess whether recurrent instability had developed . Functional assessment s were made and were compared for two subgroups : those who had not had instability develop and those who had received operative stabilization to treat recurrent instability . RESULTS On survival analysis , instability developed in 55.7 % of the shoulders within the first two years after the primary dislocation and increased to 66.8 % by the fifth year . The younger male patients were most at risk of instability , and 86.7 % of all of the patients known to have recurrent instability had this complication develop within the first two years . A small but measurable degree of functional impairment was present at two years after the initial dislocation in most patients . Sample -size calculations revealed that a relatively small number of patients with a primary dislocation would be required in future clinical trials examining the effects of interventions design ed to reduce the prevalence of recurrent instability and improve the functional outcome . CONCLUSIONS Recurrent instability and deficits of shoulder function are common after primary nonoperative treatment of an anterior shoulder dislocation . There is substantial variation in the risk of instability , with younger males having the highest risk and females having a much lower risk . Future clinical trials to evaluate primary interventions should evaluate the prevalence of recurrent instability and functional deficits , with use of an assessment tool specifically for shoulder instability , during the first two years after the initial dislocation There are many measurement tools for assessing patients ’ shoulder symptoms ( pain ) and function ( what patients can do ) , but they do not measure activity ( how often a patient engages in activity ) . This is relevant because activity level can have an important impact on a patient ’s outcome . Our goal was to develop a short , easy to administer measure of shoulder activity which could be used to predict outcome of shoulder disorders . The activity scale was developed using established principles : item generation , item reduction , pretesting , and reliability and validity testing . The activity rating is a numerical sum of scores for five activities rated on a five-point frequency scale from never performed ( 0 points ) to daily ( 4 points ) . Patients were scored on the following criteria : carrying an object 8 lb or heavier by h and , h and ling objects overhead , weight training with arms , swinging motion ( ie , hitting tennis or golf ball ) , and lifting objects 25 lb or heavier . Two additional multiple choice questions provide a score assessing participation in contact and overhead sports . The activity scale showed excellent reliability and construct validity . It can be completed quickly and used in conjunction with patient-based measures of shoulder outcome to define patient population s for cohort studies , and to assess activity level as a prognostic factor in patients with shoulder disorders . Level of Evidence : Prognostic study , Level I. See the Guidelines for Authors for a complete description of levels of evidence BACKGROUND Anterior dislocation of the glenohumeral joint in younger patients is associated with a high risk of recurrence and persistent functional deficits . The aim of this study was to assess the efficacy of a primary arthroscopic Bankart repair , while controlling for the therapeutic effects produced by the arthroscopic intervention and joint lavage . METHODS In a single-center , double-blind clinical trial , eighty-eight adult patients under thirty-five years of age who had sustained a primary anterior glenohumeral dislocation were r and omized to receive either an arthroscopic examination and joint lavage alone or together with an anatomic repair of the Bankart lesion . Assessment of the rate of recurrent instability , functional outcome ( with use of three scores ) , range of movement , patient satisfaction , direct health-service costs , and treatment complications was completed for eighty-four of these patients ( forty-two in each group ) during the subsequent two years . RESULTS In the two years after the primary dislocation , the risk of a further dislocation was reduced by 76 % and the risk of all recurrent instability was reduced by 82 % in the Bankart repair group compared with the group that had arthroscopy and lavage alone . The functional scores were also better ( p < 0.05 ) , the treatment costs were lower ( p = 0.012 ) , and patient satisfaction was higher ( p < 0.001 ) after arthroscopic repair . The improved functional outcome appeared to be mediated through the prevention of instability since the functional outcome in patients with stable shoulders was similar , irrespective of the initial treatment allocation . The patients who had a Bankart repair and played contact sports were also more likely to have returned to their sport at two years ( relative risk = 3.4 , p = 0.007 ) . CONCLUSIONS Following a first-time anterior dislocation of the shoulder , there is a marked treatment benefit from primary arthroscopic repair of a Bankart lesion , which is distinct from the so-called background therapeutic effect of the arthroscopic examination and lavage of the joint . However , primary repair does not appear to confer a functional benefit to patients with a stable shoulder at two years after the dislocation Background Nonoperative treatment of traumatic shoulder dislocations leads to a high rate of recurrent dislocations . Hypothesis Early arthroscopic treatment for shoulder dislocation will result in a lower recurrence rate than nonoperative treatment . Study Design Prospect i ve , r and omized clinical trial . Methods Two groups of patients were studied to compare nonoperative treatment with arthroscopic Bankart repair for acute , traumatic shoulder dislocations in young athletes . Fourteen nonoperatively treated patients underwent 4 weeks of immobilization followed by a supervised rehabilitation program . Ten operatively treated patients underwent arthroscopic Bankart repair with a bioabsorbable tack followed by the same rehabilitation protocol as the nonoperatively treated patients . The average follow-up was 36 months . Results Three patients were lost to follow-up . Twelve nonoperatively treated patients remained for follow-up . Nine of these ( 75 % ) developed recurrent instability . Six of the nine have required subsequent open Bankart repair for recurrent instability . Of the nine operatively treated patients available for follow-up , only one ( 11.1 % ) developed recurrent instability . Conclusions Arthroscopic stabilization of traumatic , first-time anterior shoulder dislocations is an effective and safe treatment that significantly reduces the recurrence rate of shoulder dislocations in young athletes when compared with conventional , nonoperative treatment BACKGROUND An initial anterior dislocation of the shoulder becomes recurrent in 66 % to 94 % of young patients after immobilization of the shoulder in internal rotation . Magnetic resonance imaging and studies of cadavera have shown that coaptation of the Bankart lesion is better with the arm in external rotation than it is with the arm in internal rotation . Our aim was to determine the benefit of immobilization in external rotation in a r and omized controlled trial . METHODS One hundred and ninety-eight patients with an initial anterior dislocation of the shoulder were r and omly assigned to be treated with immobilization in either internal rotation ( ninety-four shoulders ) or external rotation ( 104 shoulders ) for three weeks . The primary outcome measure was a recurrent dislocation or subluxation . The minimum follow-up period was two years . RESULTS The follow-up rate was seventy-four ( 79 % ) of ninety-four in the internal rotation group and eighty-five ( 82 % ) of 104 in the external rotation group . The compliance rate was thirty-nine ( 53 % ) of seventy-four in the internal rotation group and sixty-one ( 72 % ) of eighty-five in the external rotation group ( p = 0.013 ) . The intention-to-treat analysis revealed that the recurrence rate in the external rotation group ( twenty-two of eighty-five ; 26 % ) was significantly lower than that in the internal rotation group ( thirty-one of seventy-four ; 42 % ) ( p = 0.033 ) with a relative risk reduction of 38.2 % . In the subgroup of patients who were thirty years of age or younger , the relative risk reduction was 46.1 % . CONCLUSIONS Immobilization in external rotation after an initial shoulder dislocation reduces the risk of recurrence compared with that associated with the conventional method of immobilization in internal rotation . This treatment method appears to be particularly beneficial for patients who are thirty years of age or younger BACKGROUND During 1978 and 1979 , we initiated a prospect i ve multicenter study to evaluate the results of nonoperative treatment of primary anterior shoulder dislocation . In the current report , we present the outcome after twenty-five years . METHODS Two hundred and fifty-five patients ( 257 shoulders ) with an age of twelve to forty years who had a primary anterior shoulder dislocation were managed with immobilization ( achieved by tying the arm to the torso with use of a b and age ) or without immobilization . All 227 living patients ( 229 shoulders ) completed the follow-up question naire , and 214 patients completed the Disabilities of the Arm , Shoulder and H and ( DASH ) question naire . RESULTS Ninety-nine ( 43 % ) of 229 shoulders had not redislocated , and seventeen ( 7 % ) redislocated once . Thirty-three recurrent dislocations had become stable over time ( 14.4 % ) , and eighteen were considered to be still recurrent ( 7.9 % ) . Sixty-two shoulders ( 27 % ) had undergone surgery for the treatment of recurrent instability . Immobilization after the primary dislocation did not change the prognosis . Only two of twenty-four shoulders with a fracture of the greater tuberosity at the time of the primary dislocation redislocated ( p < 0.001 ) . When shoulders with a fracture of the greater tuberosity were excluded , forty-four ( 38 % ) of 115 shoulders in patients who had been twelve to twenty-five years of age at the time of the original dislocation and sixteen ( 18 % ) of ninety shoulders in patients who had been twenty-six to forty years of age had undergone surgical stabilization . At twenty-five years , fourteen ( 23 % ) of sixty-two shoulders that had undergone surgical stabilization were in patients who subsequently had a contralateral dislocation , compared with seven ( 7 % ) of ninety-nine shoulders in patients in whom the index dislocation had been classified as solitary ( p = 0.01 ) . Gender and athletic activity did not appear to affect the redislocation rate ; however , women had worse DASH scores than men did ( p = 0.006 ) . CONCLUSIONS After twenty-five years , half of the primary anterior shoulder dislocations that had been treated nonoperatively in patients with an age of twelve to twenty-five years had not recurred or had become stable over time PURPOSE To compare the results of arthroscopic repair in acute anterior shoulder traumatic dislocation with those of nonoperative treatment . TYPE OF STUDY A prospect i ve nonr and omized study was performed . METHODS Between August 1989 and April 1997 , 46 patients were seen after a first episode of traumatic anterior shoulder dislocation . The average age was 21 years ( range , 17 to 27 years ) . Most dislocations were in rugby players ( 36 patients ) . There were 18 patients treated by nonoperative methods and 28 patients treated by acute arthroscopic repair ; 22 patients using transglenoid suture and 6 patients with bone anchor suture fixation . RESULTS Of the patients treated nonoperatively , 94.5 % suffered a redislocation between 4 and 18 months ( average , 6 months ) . In the operative group , 96 % of the patients ( 27 ) obtained excellent results according to the Rowe scale . Only 1 patient suffered a redislocation 1 year after surgery . Three different types of lesions were found during surgery : group I , capsular tear with no labrum lesion ( 4 % ) ; group II , capsular tear with partial labrum detachment ( 32 % ) ; and group III , capsular tear and full anterior labrum detachment ( 64 % ) . The average follow-up was 67.4 months ( range , 28 to 120 ) . There were no surgical complications . CONCLUSIONS The operative group obtained 96 % excellent results , but the nonoperative group only obtained 5.5 % excellent results , according to the Rowe scale . The nonoperative group showed a high incidence of redislocation ( 94.5 % ) compared with the operative group ( 4 % ) . Based on the findings of this study , we recommend using an arthroscopic evaluation and repair after an initial anterior traumatic shoulder dislocation in young athletes A prospect i ve study evaluating nonoperative treatment versus arthroscopic Bankart suture repair for acute , ini tial dislocation of the shoulder was undertaken in young athletes . All patients met the following criteria : 1 ) sus tained an acute first-time traumatic anterior dislocation , 2 ) no history of impingement or occult subluxation , 3 ) the dislocation required a manual reduction , and 4 ) no concomitant neurologic injury . Thirty-six athletes ( average age , 20 years ) met the criteria for inclusion . Group I patients were immobilized for 1 month followed by rehabilitation ; they were allowed full activity at 4 months . Group II patients underwent arthroscopic Bankart repair followed by the same protocol as Group I. Group I consisted of 15 athletes . Twelve patients ( 80 % ) developed recurrent instability ; 7 of the 12 have required open Bankart repair for recurrent instability . Group I consisted of 21 patients ; 18 patients ( 86 % ) had no recurrent instability at last followup ( average , 32 months ; range , 15 to 45 ) ( P = 0.001 ) . One patient in Group II has required a subsequent open Bankart repair to treat symptomatic recurrence ( P = 0
Output:
| Arthroscopic stabilization was the preferred strategy after a primary anterior glenohumeral dislocation .
In clinical setting s where the likelihood of recurrent instability is low after nonoperative care or when an informed patient has an aversion to surgery , nonoperative treatment may be the preferred treatment strategy |
MS213981 | ***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 compare the accuracy of transvaginal sonography ( TVS ) and magnetic resonance imaging ( MRI ) in the preoperative staging of endometrial carcinoma . METHODS This was a prospect i ve study in which 74 women consecutively diagnosed with endometrial carcinoma were examined using TVS by physicians trained in gynecological sonography and MRI by radiologists with a special interest in gynecology . All patients underwent surgical-pathological staging after removal of the uterus , adnexa and pelvic lymph nodes . Sensitivity , specificity , and positive and negative predictive values were calculated for each imaging modality with regard to detection of neoplastic invasion of the outer half of the myometrium and cervical involvement . RESULTS TVS and MRI performed equally well in the preoperative staging of endometrial cancer , with no statistically significant differences between the two techniques . The sensitivity , specificity , positive and negative predictive values , and overall diagnostic accuracy for TVS in the evaluation of myometrial infiltration were 84 % , 83 % , 79 % , 88 % and 84 % , respectively . Respective values for MRI were 84 % , 81 % , 77 % , 87 % and 82 % . The corresponding statistics for detection of cervical involvement were 93 % , 92 % , 72 % , 98 % and 92 % for TVS ; and 79 % , 87 % , 58 % , 95 % and 85 % for MRI . CONCLUSIONS When carried out by expert practitioners , TVS shows good accuracy in the local staging of endometrial carcinoma . Because of its high costs , MRI should be offered only to those in whom TVS produces images of poor quality The depth of myometrial infiltration by endometrial cancer is an important prognostic factor . The examination of the depth of infiltration classifies the patients in the low- and high-risk groups , which influences the therapeutic approach . Transvaginal ultrasonography represents a first-choice diagnostic test for the assessment of the depth of myometrial infiltration as the time consumption and financial dem and s of magnetic resonance imaging need to be taken into account . In comparison with the MRI , the diagnostic accuracy of the transvaginal ultrasound depends more on the individual experience and professional potential of the examining physician . This fact can contribute to the heterogeneity of published results of transvaginal ultrasound on the determination of infiltration depth . Having in mind the aim to verify these indicators in our local conditions and environment , we decided to prospect ively study 150 endometrial cancer patients who were examined with the transvaginal ultrasound in the period 1/2009 - 10/ 2011 . Correlated firstly with the preoperative and then secondly with the definitive histopathological examination was the depth-of-infiltration-related data that had been taken from the ultrasound findings . The output being monitored was the exclusion or confirmation of the invasion exceeding half the thickness of myometrium . In our study , the diagnostic accuracy of the method reached 82.67 % , while the other indicators were as follows : sensitivity 92.31 % , specificity 79.28 % , positive predictive value ( PPV ) 61.02 % , negative predictive value ( NPV ) 96.7 % , the likelihood ratio of a positive test 4.455 and the likelihood ratio of a negative test 0.097 . The results of the depth of myometrial infiltration examination and their comparison with the data from similarly oriented clinical studies entitle us to include this examination in the set of st and ard preoperative methods used for the examination of patients with endometrial cancer ( Tab . 3 , Fig. 5 , Ref . 20 ) OBJECTIVE The purpose s of this study were to compare transvaginal sonography ( TVS ) , intraoperative sonography ( IOS ) , and gross visual inspection of the uterus with the histopathologic findings in patients with endometrioid adenocarcinoma , and to compare the accuracies of TVS , IOS , and gross visual inspection in staging of the tumor . SUBJECTS AND METHODS Sixteen patients with endometriod carcinoma were prospect ively evaluated with TVS and IOS . Intraoperative gross visual inspection was also performed . Gray-scale , duplex , and color Doppler findings were used to stage patients . The location and depth of myometrial invasion and the presence of cervical involvement were recorded . At gross visual inspection , only the absence or presence and the depth of myometrial invasion ( < or = 50 % or > 50 % ) were recorded . The data were analyzed three ways . First , in uterine specimens with myometrial invasion , a site-by-site comparison was made among the TVS and IOS findings and the final histologic results regarding location and depth of tumor invasion . Next , to determine tumor stage , myometrial invasion was defined in two ways : ( 1 ) absent , 50 % or less , or greater than 50 % ; and ( 2 ) 50 % or less or greater than 50 % . Then imaging findings , gross visual inspection , and the final histologic results were compared . RESULTS Of the 16 uterine specimens , eight had myometrial invasion , with 13 separate sites of tumor invasion . IOS correctly identified the location and depth ( + /- 10 % of the histologic depth ) of tumor invasion at four ( 31 % ) sites , and TVS at one ( 8 % ) site . TVS and IOS overestimated myometrial invasion due to adenomyosis , bulky intraluminal tumor , and lymphovascular invasion . When myometrial invasion was defined as absent , 50 % or less , or greater than 50 % , TVS was correct in 60 % of cases , IOS in 56 % , and gross visual inspection in 53 % . When myometrial invasion was defined as 50 % or less or greater than 50 % , TVS was correct in 93 % of cases , IOS in 81 % , and gross visual inspection in 80 % . CONCLUSION TVS and IOS are inaccurate in predicting the precise location and depth of myometrial tumor invasion . However , when a less rigorous definition of invasion is used , the accuracies of TVS and IOS are comparable to gross visual inspection in staging of the tumor OBJECTIVES To develop and vali date strategies , using new ultrasound-based mathematical models , for the prediction of high-risk endometrial cancer and compare them with strategies using previously developed models or the use of preoperative grading only . METHODS Women with endometrial cancer were prospect ively examined using two-dimensional ( 2D ) and three-dimensional ( 3D ) gray-scale and color Doppler ultrasound imaging . More than 25 ultrasound , demographic and histological variables were analyzed . Two logistic regression models were developed : one ' objective ' model using mainly objective variables ; and one ' subjective ' model including subjective variables ( i.e. subjective impression of myometrial and cervical invasion , preoperative grade and demographic variables ) . The following strategies were vali date d : a one-step strategy using only preoperative grading and two-step strategies using preoperative grading as the first step and one of the new models , subjective assessment or previously developed models as a second step . RESULTS One-hundred and twenty-five patients were included in the development set and 211 were included in the validation set . The ' objective ' model retained preoperative grade and minimal tumor-free myometrium as variables . The ' subjective ' model retained preoperative grade and subjective assessment of myometrial invasion . On external validation , the performance of the new models was similar to that on the development set . Sensitivity for the two-step strategy with the ' objective ' model was 78 % ( 95 % CI , 69 - 84 % ) at a cut-off of 0.50 , 82 % ( 95 % CI , 74 - 88 % ) for the strategy with the ' subjective ' model and 83 % ( 95 % CI , 75 - 88 % ) for that with subjective assessment . Specificity was 68 % ( 95 % CI , 58 - 77 % ) , 72 % ( 95 % CI , 62 - 80 % ) and 71 % ( 95 % CI , 61 - 79 % ) respectively . The two-step strategies detected up to twice as many high-risk cases as preoperative grading only . The new models had a significantly higher sensitivity than did previously developed models , at the same specificity . CONCLUSION Two-step strategies with ' new ' ultrasound-based models predict high-risk endometrial cancers with good accuracy and do this better than do previously developed models OBJECTIVE A prospect i ve study was design ed to compare transvaginal sonography with contrast-enhanced MR imaging to determine preoperatively the depth of myometrial invasion in patients with early-stage endometrial carcinoma . SUBJECTS AND METHODS In 40 patients , findings on transvaginal sonograms , unenhanced T2-weighted MR images , and contrast-enhanced T1-weighted Mr images were compared with histologic findings . The depth of myometrial invasion was classified as stage E ( tumor limited to endometrium , n = 12 ) , stage S ( superficial invasion : tumor invades up to 50 % of the myometrium , n = 15 ) , or stage D ( deep invasion : tumor invades more than 50 % of the myometrium , n = 13 ) . RESULTS Findings on transvaginal sonograms were accurate in 27 of 40 patients ( accuracy , 68 % ) ; the depth of invasion was overestimated in five patients and underestimated in eight patients . The results of unenhanced T2-weighted MR images were accurate in 27 patients ( accuracy , 68 % ) , with four overestimations and nine underestimations . The results of contrast-enhanced T1-weighted MR images were accurate in 34 patients ( accuracy , 85 % ) , with five underestimations and one overestimation . In the assessment of each stage of myometrial invasion , the sensitivity and specificity of contrast-enhanced T1-weighted imaging were higher than those of T2-weighted MR imaging and transvaginal sonography . The false-positive diagnoses based on transvaginal sonograms and T2-weighted images , respectively , involved polypoid tumors ( n = 4 and 2 ) , distension of the endometrial cavity by pyometra ( n = 2 and 1 ) , the presence of myoma ( n = 2 and 1 ) , atrophy of the myometrium ( n = 1 and 0 ) , and poor tumor/myometrium contrast ( n = 0 and 2 ) . On contrast-enhanced MR images , accuracy was influenced only in a case of polypoid tumor , because tumor , endometrial cavity , and myometrium were clearly distinguished and residual myometrium was clearly visualized . With all imaging techniques , false-negative diagnoses were caused mainly by tumors with superficially spreading growth or microscopic invasion . With transvaginal sonography , infiltrative tumor also tended to be understaged ( n = 3 ) . CONCLUSION Contrast-enhanced MR imaging is significantly superior to transvaginal sonography and unenhanced T2-weighted MR imaging for detecting myometrial invasion In recent years , the incidence of carcinoma of the endometrium has shown an upward trend , such that it is currently the most frequently encountered malignant tumor of the female genital tract . An accurate preoperative diagnosis of the extent and spread of such carcinomas is of crucial importance for the selection of a therapeutic approach appropriate to the stage and infiltration of each particular tumor . In a prospect i ve study of 80 patients with a carcinoma of the endometrium , performed at the Department of Obstetrics and Gynecology of the University of Mainz , we compared the preoperative findings of transvaginal sonography with the postoperative histological results with respect to the following parameters : endometrial thickness , demarcation of the boundary of the endometrium , myometrial infiltration depth and staging . In all of these patients , sonography revealed a distinct increase in the thickness of the endometrium . In all cases , the structure of the endometrium was found to be heterogenous , with an irregular and poorly delineated boundary . Assessment s of the depth of tumor infiltration and the tumor staging obtained by transvaginal sonography were found to correlate with the histological findings in 85 % and 87.5 % of the cases , respectively . Thus , in cases of endometrial carcinoma , transvaginal sonography has an essential role to play in devising an individualized operative treatment program that takes into account the extent , spread and stage of the tumor OBJECTIVE To compare the ability of transvaginal sonography and serum CA 125 levels to predict myometrial invasion in patients with endometrial carcinoma . DESIGN AND METHODS Prospect i ve study in 50 consecutive patients ( mean age 60 years , SD 10.5 , range 29 - 77 years ) diagnosed as having endometrial cancer and scheduled for surgical staging . All patients were evaluated by transvaginal ultrasonography . Endometrial thickness was measured in all cases and myometrial invasion was estimated as < 50 % or > or = 50 % . Serum CA 125 level was determined in each patient . A cut-off level of > or = 35 IU/ml was considered to predict myometrial invasion of > or = 50 % . All patients underwent surgical staging , and definitive histopathological findings regarding myometrial invasion were used as the ' gold st and ard ' . Sensitivity , specificity and positive predictive value ( PPV ) and negative predictive value ( NPV ) were calculated for transvaginal ultrasonography and CA 125 and compared . RESULTS On histopathological analysis
Output:
| Diagnostic performance of TVS for detecting deep myometrial infiltration in women with endometrial cancer is moderate |
MS213982 | ***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 effects of a stabilized 0.454 % stannous fluoride dentifrice , currently marketed as Crest Gum Care , on supragingival plaque , gingivitis , gingival bleeding and oral soft tissue condition were studied in 328 adult male and female subjects who completed a six-month , double blind clinical study . Following initial examinations , subjects presenting with a minimum of five gingival bleeding sites received a thorough dental prophylaxis and were instructed to brush at least twice a day for three months with a commercially available fluoride dentifrice , packaged in such a way as to blind its identity to the study subjects . This constituted the three-month pre-test period . At the end of this period , subjects were again examined , given a second oral prophylaxis , and r and omly assigned to brush with one of the following dentifrices : 1 ) stabilized 0.454 % stannous fluoride , 2 ) 0.243 % sodium fluoride control , or 3 ) one of three experimental dentifrices . Subjects were instructed to brush their teeth as they normally would , at least twice a day for one minute per brushing . Follow-up examinations after three and six months of dentifrice use evaluated supragingival plaque , gingivitis , gingival bleeding , extrinsic tooth stain and oral soft tissue status . After six months , the stabilized stannous fluoride dentifrice significantly reduced gingivitis and gingival bleeding by 20.5 % and 33.4 % compared to the sodium fluoride control group . However , the stabilized stannous fluoride dentifrice group was not significantly different from the control dentifrice group with respect to supragingival plaque scores . As expected , accumulation of extrinsic tooth stain was greater in the stabilized stannous fluoride group than the control group . No unexpected nor clinical ly significant oral soft tissue health effects were associated with the use of the test dentifrices . The results from this clinical study demonstrate that over a six-month period , twice-daily use of a dentifrice containing 0.454 % stabilized stannous fluoride significantly reduced gingivitis and gingival bleeding , relative to a 0.243 % sodium fluoride control dentifrice This double-blind parallel- design clinical study compared the efficacy of a stabilized stannous fluoride dentifrice ( Crest Plus Gum Care ) , baking soda and peroxide ( NaF ) dentifrice ( Mentadent ) , and essential oil mouthrinse ( Listerine ) to a conventional NaF dentifrice ( Crest ) for the control of plaque , gingivitis and gingival bleeding over six months . Following an initial baseline examination and stratification , subjects received a complete oral prophylaxis and were distributed assigned test products . Following three and six months , subjects re-visited the clinic for examinations . Evaluations at baseline and at 3 and 6 months included soft tissue status . Löe-Silness gingivitis/gingival bleeding , Silness-Löe plaque and dental stain . Results subsequent to six months of product use were as follows : At six months , the stabilized stannous fluoride dentifrice was observed to produce statistically significant 17.5 % reductions in gingivitis and 27.5 % reductions in gingival bleeding relative to the NaF dentifrice . The combination of sodium fluoride dentifrice and essential oil mouthrinse produced statistically significant reductions of 7.4 % in gingivitis and 10.8 % in plaque as compared with the NaF dentifrice . The stabilized stannous fluoride dentifrice produced statistically significant reductions in both gingivitis ( 10.8 % ) and gingival bleeding ( 23.0 % ) relative to the combination of sodium fluoride dentifrice and essential oil mouthrinse . The baking soda and peroxide ( NaF ) dentifrice did not provide reductions in gingivitis , plaque or gingival bleeding as compared with the conventional NaF dentifrice . The stabilized stannous fluoride dentifrice provided statistically significant reductions in gingivitis as compared with the baking soda and peroxide dentifrice following six months of use , and both the essential oil mouthrinse and stabilized stannous fluoride dentifrice provided statistically significant reductions in gingivitis as compared with the baking soda and peroxide dentifrice following three months of use . These results support : 1 ) the efficacy of stabilized stannous fluoride dentifrice and the combination of sodium fluoride dentifrice and essential oil mouthrinse for the prevention of gingivitis ; 2 ) the superior activity of stabilized stannous fluoride dentifrice as compared with a combination of sodium fluoride dentifrice and essential oil mouthrinse for the control of gingivitis and gingival bleeding ; and 3 ) the lack of efficacy for baking soda and peroxide dentifrice for the control of plaque , gingivitis and gingival bleeding as compared with conventional fluori date d dentifrice A primary patient motivation for oral hygiene is effective cleaning . Dentifrice serves this function by including ingredients such as abrasives , surfactants , and specialized cleaning ingredients such as anticalculus agents . This introductory article aims to introduce professionals , educators , and research ers on the rationale behind the development of an improved cleaning dentifrice formulation , Crest Multicare Advanced Cleaning . This new dentifrice is based upon the application of an improved tartar control/cleaning ingredient that is a polymeric adjunct of a pyrophosphate anion commonly applied in tartar control and stain control whitening dentifrices . The polypyrophosphate anion , also referred to as sodium hexametaphosphate , produces superior activity and substantivity on oral surfaces as compared to both pyrophosphate and some other commonly used dental cleaning ingredients and cleaning/conditioning adjuncts . The increased activity and substantivity translate into significant improvements in the prevention of dental stains and supragingival calculus and in the non-abrasive removal of dental stains . This article describes the structure of polypyrophosphate as compared to the parent pyrophosphate molecule , the rationale for its improved chemistry , and , in particular , its tartar control chemistry . In addition , the fundamental mechanisms of calculus formation and inhibition are review ed . Lastly , a preliminary clinical study evaluating the improved efficacy of a polypyrophosphate dentifrice is described where the tartar control activity of the polypyrophosphate dentifrice is shown to be superior to that of a clinical ly established and marketed industry st and ard pyrophosphate dentifrice BACKGROUND AND AIMS R and omised , blind , controlled experimental gingivitis and home-use study protocol s are used to evaluate the efficacy of oral hygiene products . The present method ological study combined the two clinical trial design s to compare the preventive and therapeutic potentials of two toothpastes . MATERIAL AND METHODS The study was a parallel group , r and omised , double-blind design , initially involving 73 healthy dentate subjects . A 21-day experimental gingivitis protocol was combined with a 6-week ( 42 days ) home-use protocol . At baseline , modified gingival index ( MGI ) , gingival index ( GI ) and gingival bleeding ( GB ) were recorded . A dental prophylaxis was then performed . Subjects were allocated to either control fluoride or stannous fluoride toothpaste based on gender and GI . During the first 21-day period , subjects applied the allocated toothpaste , for 1 min twice a day , to a group of teeth in a plastic shield and brushed the remaining teeth with the same paste . From day 21 the shield was not placed , and subjects brushed all teeth with the toothpaste for 1 min twice per day up to day 42 . MGI , GB and a plaque index ( PI ) were recorded on days 21 and 42 . RESULTS Sixty-nine and 67 subjects completed to days 21 and 42 , respectively . For shielded teeth , PI , MGI and GB increased to day 21 and then after ceasing the use of the shield decreased to day 42 . At day 21 , PI favoured the stannous fluoride toothpaste , but differences did not achieve statistical significance for any parameter at days 21 or 42 . For unshielded teeth , there were no significant differences between the toothpastes for any parameter at either time point . CONCLUSION : The feasibility of combining two gingivitis clinical trial method ologies appears proven , and data on both the preventive and therapeutic chemical and mechanical efficacy of toothpastes can be obtained through such protocol s. Specifically from the present study and consistent with some other reports , the plaque inhibitory properties of the stannous fluoride product are limited and do not always translate into an antiplaque/antigingivitis effect The effects of stabilized 0.454 % stannous fluoride dentifrices on supragingival plaque , gingival inflammation and gingival bleeding were studied in 549 adult male and female subjects who completed a six-month , double blind clinical study . Following an oral prophylaxis , subjects were r and omly assigned to brush with one of the following dentifrices : 1 ) 0.454 % SnF2 stabilized with 2.08 % sodium gluconate , 2 ) 0.454 % SnF2 stabilized with 4.16 % sodium gluconate , 3 ) an experimental dentifrice , or 4 ) 0.243 % NaF control dentifrice . Follow-up examinations were conducted at 3 and 6 months . Compared to the control dentifrice at 6 months , stannous fluoride dentifrices stabilized with 2.08 % or 4.16 % sodium gluconate significantly reduced gingivitis by 18.8 % and 18.0 % , respectively . There were no statistically significant differences between the two stabilized SnF2 groups with respect to their beneficial effects on gingival health . Gingival bleeding was also reduced , relative to the control dentifrice , for both stabilized SnF2 dentifrices . However , these differences were not statistically significant at p=0.05 . The stabilized SnF2 dentifrices were not significantly different from the control dentifrice in their effects on supragingival plaque . No significant differences in adverse oral soft tissue effects were observed between the test and control groups . As expected , accumulation of extrinsic tooth stain increased in the stabilized SnF2 groups . However , the difficulty in removing accumulated dental stain was similar between the control and stabilized SnF2 dentifrices . Since use of SnF2 dentifrices has been reported to produce tooth stain , gingivitis examinations were done with and without custom-made tooth covers to evaluate the potential for examiner bias . Comparable gingivitis and gingival bleeding benefits were observed when the evaluations were conducted with or without the tooth covers . Results from this study support that 0.454 % stabilized stannous fluoride dentifrices can provide an important adjunct to the prevention and control of gingivitis when used in combination with regular personal oral hygiene procedures and professional care PURPOSE S To compare the oral malodor protection efficacy of a 0.454 % stannous fluoride dentifrice versus a negative control ( 0.243 % sodium fluoride ) using a sulfide monitor ( halimeter ) as the measurement . A secondary objective was to assess the effects of tongue brushing . METHODS This was a four-treatment , five-period , examiner-blinded , crossover , r and omized study . Healthy subjects who met the entrance criteria were enrolled into the study . A 5-day acclimation period , in which subjects brushed twice daily in their customary manner with a st and ard sodium fluoride dentifrice , occurred prior to baseline . After baseline halimeter measurements , subjects were r and omly assigned to one of four treatments ( SnF2 dentifrice groups , with or without tongue brushing ; negative control dentifrice groups , with or without tongue brushing ) based on baseline halimeter scores , age , and gender . Test products were used three times a day . Breath measurements were taken 24 hours after baseline ( after three product uses ) . Subjects then brushed again with the product treatment . Final breath measurements were taken 4 hours later , 28 hours after baseline . A 5-day washout separated each treatment period . RESULTS 33 subjects were enrolled and completed the study . The adjusted mean volatile sulfur compound ( VSC ) levels were significantly lower in the SnF2 groups than the NaF groups , at both 24 ( P < 0.01 ) and 28 ( P < 0.001 ) hours post baseline time points . Tongue brushing did not provide additional statistically significant breath benefits when compared to toothbrushing alone . Both dentifrices were well tolerated This r and omized and controlled , examiner blind , parallel group study was undertaken to evaluate the efficacy of three commercial dentifrices on breath malodor . A total of 384 healthy adult subjects with oral malodor were r and omized to one of four brushing groups , using either an antimicrobial dentifrice containing 0.45 % stannous fluoride , an antitartar dentifrice containing 0.243 % sodium fluoride and 5 % pyrophosphate , an antimicrobial dentifrice containing 0.24 % sodium fluoride and 0.30 % triclosan/copolymer , or bottled distilled water which served as the negative experimental control . Breath quality was evaluated over a five-day period by second-person organoleptic grading and measurement of volatile sulfur levels . Following treatment , adjusted mean organoleptic scores and volatile sulfur levels were lowest for the stannous fluoride dentifrice group , with this group exhibiting superior breath quality compared to the negative control at three hours after a single brushing , and again at all cumulative use time points . While all test dentifrices showed some activity , only stannous fluoride had a second-person breath benefit . Breath effects for the other two dentifrices were limited to reductions in volatile sulfur levels at hours 99 and 104 for the antitartar sodium fluoride pyrophosphate dentifrice , and at hour 99 only for
Output:
| Risk of bias was high for the studies on dental calculus , halitosis , and stain , and varied for the dental plaque and gingivitis studies .
Significant reductions in dental calculus and in halitosis were reported for the SnF2 dentifrice ; no differences in stain reduction were noted .
Conclusions The present review found that stabilized SnF2 toothpaste had a positive effect on the reduction of dental calculus build-up , dental plaque , gingivitis , stain and halitosis .
A tendency towards a more pronounced effect than using toothpastes not containing SnF2 was found .
Clinical relevance Adding a SnF2 toothpaste to the daily oral care routine is an easy strategy that may have multiple oral health benefits |
MS213983 | ***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 Considering formocresol 's toxicity , Ca(OH)(2 ) partial pulpotomy ( PP ) was studied as a treatment alternative . AIM To compare success rates of Ca(OH)(2 ) PP versus formocresol pulpotomy ( FP ) treatment of pulpally exposed lower primary molars . DESIGN A total of 84 lower primary molars , which met study criteria , from 56 child patients were r and omly assigned for each treatment . After treatment , blinded clinical and radiographic evaluation with 96.9 % and 90 % reliability was performed at 6-month intervals to determine treatment success/failure . Chi-squared test was used to compare success rates between the two treatments . RESULTS The success rates from 6 to 36 months for PP ranged from 95.03 % to 75 % , whereas for FP , it was 92.7 - 74.2 % . The success rates for the two treatments at each 6-month interval were not different ( P ≥ 0.05 ) . The most frequent failure was internal resorption , affecting five FP teeth and three PP teeth . The resorption was arrested in five of the teeth and was replaced by a radiopaque calcified tissue in one case . CONCLUSION Considering the favourable clinical and radiographic success rate of PP and the potentially toxic effects of formocresol leads us to recommend the use of PP instead of FP in primary teeth with deep carious lesions Aim To compare the clinical and radiographic success rates of three different pulpotomy agents in primary molars after 18 months . Methods The study was carried out with 51 primary molars of children aged 5–9 years old . The teeth were r and omly assigned to the experimental or control groups . After coronal pulp removal and haemostasis , the remaining pulp tissue was covered with Biodentine ® or mineral trioxide aggregate in the experimental groups . In the control group , formocresol was placed with a cotton pellet over the pulp tissue for 5 min and after removal the pulp tissue was covered with zinc oxide – eugenol ( ZOE ) paste . All teeth were immediately restored with reinforced ZOE base and resin modified glass-ionomer cement , and later with pre-formed metal crowns . Follow-up assessment s were carried out after 3 , 6 , 12 and 18 months . Results Forty-five teeth were available for follow up at the end of 18 months . All of the available teeth for mineral trioxide aggregate and Biodentine ® were clinical ly successful , as were 73.3 % of the FC group . Radiographic success rate for the formocresol group at 18 months follow up was 73.3 , 100 % for mineral trioxide aggregate and 86.6 % for Biodentine ® group . Conclusion Mineral Trioxide aggregate and Biodentine ® showed more favourable results than formocresol PURPOSE The purpose of this study was to investigate the outcomes of vital primary molar pulpotomy when there is no direct contact between eugenol and the vital pulp . Four pulpotomy techniques were compared : ( 1 ) ferric sulfate ( FS ) pulpotomy ; ( 2 ) eugenol-free FS pulpotomy ; ( 3 ) mineral trioxide aggregate ( MTA ) pulpotomy ; and ( 4 ) FS/MTA pulpotomy . METHODS The pulpotomy technique assigned to each molar was determined by r and om selection . Two blinded , disinterested raters classified each molar into 1 of 3 radiographic outcomes : ( 1 ) N = normal molar without pathologic change ; ( 2 ) Po = pathologic change present , follow-up recommended ; ( 3 ) Px = pathologic change present , extract . RESULTS A total of 92 patients with 227 pulpotomy-treated molars returned for at least 1 recall examination . Median follow-up for molars was 24 months ( range=12 - 38 months ) . MTA molars demonstrated significantly fewer Px radiographic outcomes than FS molars ( P=.002 , chi-square test ) . Eugenol-free FS molars demonstrated significantly more Px radiographic outcomes than MTA ( P<.001 , chi-square test ) or FS/MTA ( P=.002 , chi-square test ) molars . Significantly lower survival was demonstrated for eugenol-free FS molars compared to MTA molars ( P=.02 , log-rank test ) over 6 to 38 months . CONCLUSIONS Outcomes for mineral trioxide aggregate pulpotomy were superior to ferric sulfate and eugenol-free ferric sulfate pulpotomy after a median follow-up of 2 years Introduction : This trial was design ed to evaluate the clinical and radiographic success rates of calcium-enriched mixture ( CEM ) cement with and without low level laser therapy ( LLLT ) and compare them to that of formocresol ( FC ) and ferric sulfate ( FS ) in primary molar pulpotomies . Methods and Material s : This r and omized clinical trial was conducted on a total of 160 teeth selected from 40 patients aged 3 - 9 years . Patients with at least four primary molars needing pulpotomy , were included in order to have each tooth assigned r and omly in one of the four following groups ; FC , FS , CEM , and LLLT/CEM . Six- and twelve-month follow-up periods were conducted in order to enable a clinical and radiographic evaluation of the treated teeth . Collected data were analyzed using Cochran Q Tests . Results : The 12-month clinical success rate for each technique was : FC=100 % , FS=95 % , CEM=97.5 % and LLLT/CEM=100 % with no significant differences ( P>0.05 ) . Furthermore , 12-month radiographic success rate for each technique was : FC=100 % , FS=92.5 % , CEM=95 % and LLLT/CEM=100 % with no significant differences ( P>0.05 ) . Conclusion : Favorable outcomes of four treatment techniques in pulpotomy of primary molar teeth were comparable . CEM with/without LLLT may be considered as a safe and successful pulpotomy treatment modality compared to current conventional methods Introduction : Pulpotomy technique is most widely accepted clinical procedure for treating primary teeth with coronal pulp inflammation caused by caries with no involvement of the radicular pulp . Aim and Objective : The aim of the study was to evaluate the success and efficacy of mineral trioxide aggregate ( MTA ) and antioxidant mix as pulpotomy agents both clinical ly and radiographically . Material s and Methods : A total of forty primary molars in children aged between 6 and 9 years , requiring for pulpotomy procedures , were selected . R and om sample s distribution was done , antioxidant mix ( n = 20 ) and MTA ( n = 20 ) both were used as pulpotomy agent . Under rubber dam isolation , pulpotomy procedure was performed in all sample s followed by restoration with stainless steel crowns . Later , the patients were recalled after 6 and 12 months for clinical and radiographic evaluation . The data were evaluated using Fisher 's exact test . Results : Statistically analysis shows no significant difference between the two groups ( P > 0.05 ) with respect to clinical and radiographic success rate , but antioxidant mix showed more efficient result than MTA . Conclusion : Antioxidant mix pulpotomy is more biocompatible and cost effective than any other commercially available medicament Purpose The aim of this study was to compare the effect of white mineral trioxide aggregate ( MTA ) to that of formocresol ( FC ) as pulp dressing agents in pulpotomised primary molars . Methods In this clinical trial study , 60 lower second primary molars of 46 children were treated by a conventional pulpotomy technique . The teeth were r and omly assigned to the MTA ( experimental ) and FC ( control ) groups by r and om numbered table . Following removal of the coronal pulp and haemostasis , the pulp stumps were covered with an MTA paste in the experimental group . In the control group , FC was placed with a cotton pellet over the pulp stumps . The teeth of both groups were restored with stainless steel crowns . Children arrived for clinical and radiographic follow-up evaluation after 6 , 12 and 24 months . Results The treated teeth in FC group ( n = 18 ) were clinical ly and radiographically successful after 24 months . The radiographic follow-up evaluation revealed one failure ( furcation involvement ) in 18 molars treated with MTA after 24 months . The treated teeth in MTA group were clinical ly successful 24 months postoperatively . Pulp canal obliteration was observed in one of the teeth treated with MTA and four of the teeth treated with FC . Conclusion MTA could be used as a safe medicament for pulpotomy in cariously exposed primary molars and could be a substitute for FC The aim of this study was to compare the effect of ferric sulfate ( FS ) to that of dilute formocresol ( DFC ) as pulp dressing agents in pulpotomized primary molars . Ninety-six primary molars in 72 children were treated by a conventional pulpotomy technique . Fifty-eight teeth were treated by a FS solution for 15 sec , rinsed , and covered by zinc oxide-eugenol paste ( ZOE ) . In another 38 teeth , a cotton pellet moistened with 20 % DFC was placed for 5 min , removed , and the pulp stumps were covered by ZOE paste . The teeth of both groups were sealed by a second layer of intermediate restorative material ( IRM ) and restored with a stainless steel crown . This is a report of the clinical and radiographic examination of 55 teeth dressed with FS and 37 teeth fixed with DFC , that have been treated 6 to 34 months previously ( mean 20.5 months ) . Four teeth were excluded from the study due to failure of the patient to present for recall . Success rates of 92.7 % for the FS , and of 83.8 % for the DFC were not significantly different . Four teeth ( 7.2 % ) of the FS group and two ( 5.4 % ) of the DFC group presented internal resorption . Inter-radicular radiolucencies were observed in two teeth of the FS group and three teeth of the DFC group . The latter also presented periapical lesions . Success rates of both groups were similar to those of previous studies utilizing the traditional Buckley 's formocresol OBJECTIVES The aim of the present study was to conduct a clinical and radiographic long-term evaluation of pulpotomy in temporary molars performed with Grey and White Mineral Trioxide Aggregate ( MTA ) and compare the results of Grey and White MTA pulpotomies in a sample of 233 primary molars with a maximum follow-up period of 84 months . METHODS The sample was selected from patients treated at the Department of Pediatric Dentistry , Faculty of Dentistry , Complutense University of Madrid , Spain . This prospect i ve study included first and second primary molars treated with pulpotomy with Grey or White MTA , controlled for a maximum follow-up period of 84 months . Statistical analysis of clinical and radiographic findings was completed using ANOVA ( P<0.05 ) . RESULTS Follow-up evaluations , performed every 6 months , revealed that only 2 molars treated with White MTA presented abscess and pathological mobility . Radiographic examination of the 210 molars revealed unfavourable pulp response in only 6 molars ( internal or furcation root resorption ) , without statistically significant differences between Grey and White MTA . Two radiological findings were noticed : dentine bridge formation and partial or total root canal stenosis . Grey MTA induced a higher percentage of dentine bridges with statistically significant differences ( P<0.05 ) , and a higher percentage of pulp canal stenosis , without a statistically significant difference . CONCLUSIONS Grey and White MTA presented high levels of clinical and radiographic success . Although the present study showed evidence of a very good biologic response with both types of MTA , Grey MTA showed significantly higher number of dentine bridge formation than White MTA AIM To compare the treatment outcomes of calcium-enriched mixture ( CEM ) cement and mineral trioxide aggregate ( MTA ) as pulp dressing bio material s in vital pulpotomy of carious primary molars . STUDY DESIGN split-mouth r and omised clinical trial . MATERIAL S AND METHODS Forty children aged 4 - 8 years with 2 carious teeth requiring pulpotomy were selected and r and omly assigned to MTA ( n = 40 ) or CEM ( n = 40 ) groups . After coronal pulp removal , the remaining radicular pulp was covered with an appropriate bio material ; the teeth were then permanently restored . Clinical /radiographic success/failures were blindly evaluated at 6- , 12- and 24-month follow-ups . STATISTICS the recorded data were analyzed with McNemar test and GEE . RESULTS A total of 36 , 33 and 35 patients were available for 6- , 12- and 24-month follow-ups , respectively . At the 12-month follow-up only one and three teeth in the CEM and MTA groups had pathologic external root resorption , respectively . The resorbed teeth were then missed due to extraction /exfoliation at the 24-month follow-up ; all other treated teeth were sign/symptom-free . Overall , clinical and radiographic outcomes in both MTA/CEM groups were comparable at the three follow-ups without significant differences . Time had no significant effect on the success . CONCLUSION MTA and CEM demonstrated favourable treatment outcomes for pulpotomy of carious primary molars ; CEM may be an effective pulp dressing bio material PURPOSE The objective of this study was to assess the effect of mineral trioxide aggregate ( MTA ) as pulp dressing material following pulpotomy in primary molars with carious pulp exposure and compare them to those of formocresol ( FC ) . METHODS Of 33 children , primary molars treated via a conventional pulpotomy technique were r and omly assigned to the MTA group ( 33 teeth ) or FC group ( 29 teeth ) . Clinical and radiographic
Output:
| Mineral trioxide aggregate ( MTA ) , Biodentine and ferric sulphate yielded good clinical results over time and might be safely used in the pulpotomies of primary molars .
Among agents , MTA seemed to be the material of choice .
On the contrary , calcium hydroxide showed the worst clinical performance .
Although clinical ly successful , formocreosol should be replaced by other material s , due to its potential cytotoxicity and carcinogenicity .
Conclusion : MTA seemed to be the gold st and ard material in the pulpotomy of primary teeth .
Promising results were also provided by calcium silicate-based cements . |
MS213984 | ***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: Fifty patients with clinical suspicion of hip dislocation were investigated prospect ively with a dynamic ultrasound stress test . A posterior force was applied to hips in flexion and any movement between the femoral head and the acetabulum was measured . The results of this test showed that posterior movement ranged from 0 to 13.0 mm . Hips that were clinical ly normal had a mean movement of 1.4 mm , hips with minor clinical instability had a mean movement of 0.6 mm , hips with moderate instability had a mean movement of 4.5 mm , and those with major instability had a mean movement of 5.1 mm . This was statistically significant to a 1 % confidence interval . We propose two groups of ultrasound-detected movement : group A < 5.0 mm representing physiologic laxity , and group B ° 5.0 mm being pathological and requiring treatment Objectives The authors report the results of a selective ultrasound screening programme for congenital dislocation of the hip ( CDH ) over a period of 20 years , with the aim of defining the rate of screening , conservative treatment and late presentation requiring surgery . Methods All neonates born from June 1988 to December 2008 ( inclusive ) were included in the prospect i ve cohort , with a minimum follow-up of 12 months . All underwent an early clinical examination of the hips and those with clinical instability were referred for ultrasound at 2 weeks ; those with risk factors were sonographically examined at 6 weeks . Risk factors were defined as breech presentation , family history or foot deformity . Results 107 440 live births were clinical ly examined , 20 344 ( 18.9 % ) were referred for ultrasound assessment at either 2 weeks ( due to clinical signs ) or 6 weeks ( due to risk factors ) . 774 ( 3.8 % ) were diagnosed with dysplasia with a crude overall treatment rate of 7.2 per 1000 live births . 37 ( 0.34 per 1000 ) presented late , that is , after 12 weeks of age ; none had detectable clinical signs or risk factors . There were no false negatives . Conclusion Elective screening for developmental dysplasia of the hip in association with one stop treatment and monitoring is an effective programme . The number of infants referred increased statistically significantly year on year over the study period and generated more activity . Pavlik harness treatment rates remained acceptable and steady over the period , despite the increase in referrals . The incidence of late presenting cases ranged from 0 to 4 per year , with no secular trend and there were no ultrasound false negatives OBJECTIVE : We conducted a blinded , r and omized , controlled trial to examine whether mildly dysplastic but stable or instable hips would benefit from early treatment , as compared with watchful waiting . PATIENTS AND METHODS : A total of 128 newborns with mild hip dysplasia ( sonographic inclination angle [ α angle ] of 43 ° –49 ° ) and stable or instable but not dislocatable hips were r and omly assigned to receive either 6 weeks of abduction treatment ( immediate-treatment group ) or follow-up alone ( active-sonographic-surveillance group ) . The main outcome measurement was the acetabular inclination angle , measured by radiograph , at 1 year of age . RESULTS : Both groups included 64 newborns , and there was no loss to follow-up . With the exception of a small but statistically significant excess of girls in the active-sonographic-surveillance group , there were no statistically significant differences in baseline characteristics between the 2 groups . The mean inclination angle at 12 months was 24.2 ° for both groups ( difference : 0.1 [ 95 % confidence interval ( CI ) : −0.8 to 0.9 ] ) , and all children had improved and were without treatment . The mean α angle was 59.7 ° in the treatment group and 57.1 ° in the active-surveillance group for a difference of 2.6 ° evaluated after 1.5 and 3 months ( 95 % CI : 1.8 to 3.4 ; P < .001 ) . At 1.5 months of age , the hips had improved in all treated children but not in 5 children under active surveillance ( P = .06 ) . Among the sonographic-surveillance group , 47 % received treatment after the initial surveillance period of 1.5 months . CONCLUSIONS : Active-sonographic-surveillance halved the number of children requiring treatment , did not increase the duration of treatment , and yielded similar results at 1-year follow-up . Given a reported prevalence of 1.3 % for mildly dysplastic but stable hips , a strategy of active surveillance would reduce the overall treatment rate by 0.6 % . Our results may have important implication s for families as well as for health care costs Background : Ultrasound is increasingly being used to complement the clinical examination in assessing neonatal hip instability . The clinical examination , although highly sensitive in detecting hip instability , can lead to considerable overtreatment . Purpose : To compare anterior dynamic ultrasound and clinical examination in the assessment of neonatal hip instability and regarding treatment rates . Material and Methods : 536 newborn infants ( out of a population of 18,031 ) were selected , on the basis of a combination of risk factors , clinical signs of hip instability or ambiguous clinical findings , to undergo an anterior dynamic ultrasound examination of the hip , by a method developed by our group . This examination , performed by one out of seven experienced examiners , was compared with the st and ard clinical hip examination conducted by one of four pediatric orthopedic surgeons . The clinical examination was carried out both prior to and within a few hours after the ultrasound examination . Results : The clinical examination diagnosed 81.7 % of the hips as normal , 14.5 % as unstable , and 3.8 % as dislocatable or dislocated . With the dynamic ultrasound method , the corresponding figures were 87.8 % , 10.4 % , and 1.8 % , respectively . Use of the criteria of the clinical examination result ed in treatment of 147 infants . Using the dynamic ultrasound examination as a criterion meant that 87 infants would receive treatment . The calculated treatment rate was 0.85 % when based on the clinical stress test and 0.49 % when based on the dynamic ultrasound . Conclusion : The dynamic ultrasound results reduced the treatment rate by over 40 % when used as a basis for the decision regarding treatment Objective : To evaluate the quality of the routine examination of the newborn as carried out by senior house officers ( SHOs ) and midwives . Design : R and omised controlled trial set in a district general hospital in Southeast Engl and . Eligible babies were r and omised to a midwife ( 11 ) or an SHO ( 8) who were then video recorded undertaking the routine newborn examination . Main outcome measures : Quality of 62 observed technical and communication components of the newborn examination , as agreed between independent consultant paediatrician and senior midwife raters . Results : Major differences were found in the rated quality of examinations between midwives and SHOs for the examinations of the heart and lungs , for the overall quality of the examination , and in areas of communication skills . Quality of examination of the hips was assessed as poor for both professional groups . Where there were significant differences between examiners , the quality of the midwives ' examinations was higher . Inter-rater agreement between the consultant paediatricians and senior midwives ranged from excellent to poor for different items of the examination with a mean kappa value of 0.42 across all items indicating moderate agreement . Conclusions : The quality of midwife examinations exceeded that of SHOs . All midwives who examine receive formalised training in the examination of the newborn ; SHOs may benefit from similar specific training . Training for both professional groups may need to be review ed , particularly in relation to agreement on ' gold st and ards ' for the screening of developmental dysplasia of the hip The aim of this study was to evaluate whether universal ( all neonates ) or selective ( neonates belonging to the risk groups ) ultrasound screening of the hips should be recommended at birth . We carried out a prospect i ve , r and omised trial between 1988 and 1992 , including all newborn infants at our hospital . A total of 15 529 infants was r and omised to either clinical screening and ultrasound examination of all hips or clinical screening of all hips and ultrasound examination only of those at risk . The effect of the screening was assessed by the rate of late detection of congenital or developmental hip dysplasia in the two groups . During follow-up of between six and 11 years , only one late-detected hip dysplasia was seen in the universal group , compared with five in the subjective group , representing a rate of 0.13 and 0.65 per 1,000 , respectively . The difference in late detection between the two groups was not statistically significant ( p = 0.22 ) . When clinical screening is of high quality , as in our study , the effect of an additional ultrasound examination , measured as late-presenting hip dysplasia , is marginal . Under such circumstances , we consider that universal ultrasound screening is not necessary , but recommend selective ultrasound screening for neonates with abnormal or suspicious clinical findings and those with risk factors for hip dysplasia BACKGROUND Clinical screening aims to identify and treat neonatal hip instability associated with increased risk of hip displacement , but risks failures of diagnosis and treatment ( abduction splinting ) , iatrogenic effects , and costs to parents and health services . Our objectives were to assess clinical effectiveness and net cost of ultrasonography compared with clinical assessment alone , to provide guidance for management of infants with clinical hip instability . METHODS Infants with clinical hip instability were recruited from 33 centres in UK and Irel and and r and omised to either ultrasonographic hip examination ( n=314 ) or clinical assessment alone ( n=315 ) . The primary outcome was appearance on hip radiographs by 2 years . Secondary outcomes included surgical treatment , abduction splinting , level of mobility , re source use , and costs . Analysis was by intention to treat . FINDINGS Protocol compliance was high , and radiographic information was available for 91 % of children by 12 - 14 months and 85 % by 2 years . By age 2 years , subluxation , dislocation , or acetabular dysplasia were identified by radiography on one or both hips of 21 children in each of the groups ( relative risk 1.00 ; 95 % CI 0.56 - 1.80 ) . Fewer children in the ultrasonography group had abduction splinting in the first 2 years than did those in the no-ultrasonography group ( 0.78 ; 0.65 - 0.94 ; p=0.01 ) . Surgical treatment was required by 21 infants in the ultrasonography group ( 6.7 % ) and 25 ( 7.9 % ) in the no-ultrasonography group ( 0.84 ; 0.48 - 1.47 ) . One child from the ultrasonography group and four from the no-ultrasonography group were not walking by 2 years ( 0.25 ; 0.03 - 2.53 ; p=0.37 ) . Infants in the ultrasonography group incurred significantly higher ultrasound costs over the first 2 years ( pound 42 vs pound 23 , mean difference pound 19 , 95 % CI 11 - 27 ) ; total hospital costs were lower for those infants , but the difference was not significant . INTERPRETATION The use of ultrasonography in infants with screen-detected clinical hip instability allows abduction splinting rates to be reduced , and is not associated with an increase in abnormal hip development , higher rates of surgical treatment by 2 years of age , or significantly higher health-service costs We evaluated risk factors for neonatal hip instability ( NHI ) at birth using ultrasonography and assessed the reliability of our ultrasound method by means of an interobserver study . The hips of 4,459 newborns were examined by ultrasound from 1988 to 1990 . The ultrasound evaluation was based mainly on measurement of femoral head coverage ( FHC ) by the bony acetabular roof . The mean FHC was 56 % in boys and 54 % in girls ( a significant difference ) . Fifty-five newborns with unstable hips had a mean FHC of 37 % , which was significantly lower than that of the normal hips . Known risk factors for NHI were confirmed ( breech position , family history of hip dysplasia , increased birth weight ) , but no new risk factors were detected . The interobserver study included 200 hips . The 95 % confidence limit for interobserver variation in FHC ( ±2 SD ) was ±8 % . Because of this moderate interobserver variation , and because the incidence of late-detected hip dysplasia was low ( 0.2 per 1,000 ) , we conclude that our method for ultrasound examination is sufficiently reliable for screening of hips in newborns INTRODUCTION Developmental dysplasia of the hip ( DDH ) can result in chronic pain , gait abnormalities and degenerative arthritis . Infants with a family history , Breech delivery or unstable/"clicking " of the hip on examination are at higher risk . The goal is to detect cases early enough for normal hip development and function by the end of adolescence , but clinical examination alone is ineffective . MATERIAL S AND METHODS All infants born at the West Middlesex University Hospital , Isle-worth , U.K. , between 3/3/2005 and 21/10/2006 underwent prospect i ve clinical screening to reveal risk factors of unstable hip on examination , family history of
Output:
| Early Dynamic Ultrasound ( DUS ) is consistently described as a reliable assessment of NIH .
Conclusions In the context of increased prevalence of DDH in rural Australia , contemporary evidence suggests that introduction of early DUS could provide rural infants with more effective screening than clinical examination alone .
Targeted early advice about posturing and simple removable supports to abduct infant hips could prevent some cases of DDH in rural Australia |
MS213985 | ***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: Eligible smokers ( N = 6,451 ) visiting the American Cancer Society 's Internet site offering cessation assistance were , with informed consent , r and omized to receive access either to a static Internet site with quitting advice or to one of five interactive sites provided by cooperating research partners . Three-month follow-up surveys were conducted via online survey with E-mail prompts , or telephone calls , to assess quitting success ; 54 % of participants provided follow-up data . Results showed no significant overall difference in cessation rates among participants assigned to the interactive or static sites . We found large differences in the utilization of the five interactive sites . When sites were grouped by level of use , a significantly higher reported 3-month cessation rate was observed among participants assigned to the more highly utilized sites than among those assigned to the less utilized sites ( 12.2 % vs. 10.2 % of all r and omized participants , 26.0 % vs. 22.1 % of followed participants ) . These findings show that interactive Internet sites yielding high levels of utilization can increase quitting success among smokers seeking assistance via the Internet Background Web-based and mobile health interventions ( also called “ Internet interventions ” or " eHealth/mHealth interventions ") are tools or treatments , typically behaviorally based , that are operationalized and transformed for delivery via the Internet or mobile platforms . These include electronic tools for patients , informal caregivers , healthy consumers , and health care providers . The Consoli date d St and ards of Reporting Trials ( CONSORT ) statement was developed to improve the suboptimal reporting of r and omized controlled trials ( RCTs ) . While the CONSORT statement can be applied to provide broad guidance on how eHealth and mHealth trials should be reported , RCTs of web-based interventions pose very specific issues and challenges , in particular related to reporting sufficient details of the intervention to allow replication and theory-building . Objective To develop a checklist , dubbed CONSORT-EHEALTH ( Consoli date d St and ards of Reporting Trials of Electronic and Mobile HEalth Applications and onLine TeleHealth ) , as an extension of the CONSORT statement that provides guidance for authors of eHealth and mHealth interventions . Methods A literature review was conducted , followed by a survey among eHealth experts and a workshop . Results A checklist instrument was constructed as an extension of the CONSORT statement . The instrument has been adopted by the Journal of Medical Internet Research ( JMIR ) and authors of eHealth RCTs are required to su bmi t an electronic checklist explaining how they addressed each subitem . Conclusions CONSORT-EHEALTH has the potential to improve reporting and provides a basis for evaluating the validity and applicability of eHealth trials . Subitems describing how the intervention should be reported can also be used for non- RCT evaluation reports . As part of the development process , an evaluation component is essential ; therefore , feedback from authors will be solicited , and a before-after study will evaluate whether reporting has been improved Background Studies suggest that tailored material s are superior to nontailored material s in supporting health behavioral change . Several trials on tailored Internet-based interventions for smoking cessation have shown good effects . There have , however , been few attempts to isolate the effect of the tailoring component of an Internet-based intervention for smoking cessation and to compare it with the effectiveness of the other components . Objective The study aim was to isolate the effect of tailored emails in an Internet-based intervention for smoking cessation by comparing two versions of the intervention , with and without tailored content . Methods We conducted a two-arm , r and omized controlled trial of the open and free Norwegian 12-month follow-up , fully automated Internet-based intervention for smoking cessation , slutta.no . We collected information online on demographics , smoking , self-efficacy , use of the website , and participant evaluation at enrollment and subsequently at 1 , 3 , and 12 months . Altogether , 2298 self-selected participants aged 16 years or older registered at the website between August 15 , 2006 and December 7 , 2007 and were r and omly assigned to either a multicomponent , nontailored Internet-based intervention for smoking cessation ( control ) or a version of the same Internet-based intervention with tailored content delivered on the website and via email . Results Of the r and omly assigned participants , 116 ( of 419 , response rate = 27.7 % ) in the intervention group and 128 ( of 428 , response rate = 29.9 % ) in the control group had participated over the 12 months and responded at the end of follow-up . The 7-day intention-to-treat abstinence rate at 1 month was 15.2 % ( 149/982 ) among those receiving the tailored intervention , compared with 9.4 % ( 94/999 ) among those who received the nontailored intervention ( P < .001 ) . The corresponding figures at 3 months were 13.5 % ( 122/902 ) and 9.4 % ( 84/896 , P = .006 ) and at 12 months were 11.2 % ( 47/419 ) and 11.7 % ( 50/428 , P = .91 ) . Likewise , the intervention group had higher self-efficacy and perceived tailoring at 1 and 3 months . Self-efficacy was found to partially mediate the effect of the intervention . Conclusion Tailoring an Internet-based intervention for smoking cessation seems to increase the success rates in the short term , but not in the long term Background Although many smokers seek Internet-based cessation assistance , few studies have experimentally evaluated long-term cessation rates among cigarette smokers who receive Internet assistance in quitting . Objective The purpose of this study is to describe long-term smoking cessation rates associated with 6 different Internet-based cessation services and the variation among them , to test the hypothesis that interactive and tailored Internet services yield higher long-term quit rates than more static Web-posted assistance , and to explore the possible effects of level of site utilization and a self-reported indicator of depression on long-term cessation rates . Method In 2004 - 05 , a link was placed on the American Cancer Society ( ACS ) website for smokers who wanted help in quitting via the Internet . The link led smokers to the QuitLink study website , where they could answer eligibility questions , provide informed consent , and complete the baseline survey . Enrolled participants were r and omly assigned to receive emailed access to one of five tailored interactive sites provided by cooperating research partners or to a targeted , minimally interactive ACS site with text , photographs , and graphics providing stage-based quitting advice and peer modeling . Results 6451 of the visitors met eligibility requirements and completed consent procedures and the baseline survey . All of these smokers were r and omly assigned to one of the six experimental groups . Follow-up surveys done online and via telephone interviews at approximately 13 months after r and omization yielded 2468 respondents ( 38 % ) and found no significant overall quit rate differences among those assigned to the different websites ( P = .15 ) . At baseline , 1961 participants ( 30 % ) reported an indicator of depression . Post hoc analyses found that this group had significantly lower 13-month quit rates than those who did not report the indicator ( all enrolled , 8 % vs 12 % , P < .001 ; followed only , 25 % vs 31 % , P = .003 ) . When the 4490 participants ( 70 % ) who did not report an indicator of depression at baseline were separated for analysis , the more interactive , tailored sites , as a whole , were associated with higher quitting rates than the less interactive ACS site : 13 % vs 10 % ( P = .04 ) among 4490 enrolled and 32 % vs 26 % ( P = .06 ) among 1798 followed . Conclusions These findings show that Internet assistance is attractive and potentially cost-effective and suggest that tailored , interactive websites may help cigarette smokers who do not report an indicator of depression at baseline to quit and maintain cessation Background Web-based computer-tailored approaches have the potential to be successful in supporting smoking cessation . However , the potential effects of such approaches for relapse prevention and the value of incorporating action planning strategies to effectively prevent smoking relapse have not been fully explored . The Stay Quit for You ( SQ4U ) study compared two Web-based computer-tailored smoking relapse prevention programs with different types of planning strategies versus a control group . Objectives To assess the efficacy of two Web-based computer-tailored programs in preventing smoking relapse compared with a control group . The action planning ( AP ) program provided tailored feedback at baseline and invited respondents to do 6 preparatory and coping planning assignments ( the first 3 assignments prior to quit date and the final 3 assignments after quit date ) . The action planning plus ( AP+ ) program was an extended version of the AP program that also provided tailored feedback at 11 time points after the quit attempt . Respondents in the control group only filled out question naires . The study also assessed possible dose – response relationships between abstinence and adherence to the programs . Methods The study was a r and omized controlled trial with three conditions : the control group , the AP program , and the AP+ program . Respondents were daily smokers ( N = 2031 ) , aged 18 to 65 years , who were motivated and willing to quit smoking within 1 month . The primary outcome was self-reported continued abstinence 12 months after baseline . Logistic regression analyses were conducted using three sample s : ( 1 ) all respondents as r and omly assigned , ( 2 ) a modified sample that excluded respondents who did not make a quit attempt in conformance with the program protocol , and ( 3 ) a minimum dose sample that also excluded respondents who did not adhere to at least one of the intervention elements . Observed case analyses and conservative analyses were conducted . Results In the observed case analysis of the r and omized sample , abstinence rates were 22 % ( 45/202 ) in the control group versus 33 % ( 63/190 ) in the AP program and 31 % ( 53/174 ) in the AP+ program . The AP program ( odds ratio 1.95 , P = .005 ) and the AP+ program ( odds ratio 1.61 , P = .049 ) were significantly more effective than the control condition . Abstinence rates and effects differed per sample . Finally , the results suggest a dose – response relationship between abstinence and the number of program elements completed by the respondents . Conclusion Despite the differences in results caused by the variation in our analysis approaches , we can conclude that Web-based computer-tailored programs combined with planning strategy assignments and feedback after the quit attempt can be effective in preventing relapse 12 months after baseline . However , adherence to the intervention seems critical for effectiveness . Finally , our results also suggest that more research is needed to assess the optimum intervention dose . Trial Registration Dutch Trial Register : NTR1892 ; http://www.trialregister.nl/trialreg/admin/ rct view.asp?TC=1892 ( Archived by WebCite at http://www.webcitation.org/693S6uuPM Background Online computer-tailored smoking cessation programs have not yet been compared directly . Objective To compare the efficacy of two Internet-based , computer-tailored smoking cessation programs . Methods R and omized controlled trial conducted in 2003 - 2004 . Visitors to a smoking cessation website were r and omly assigned to either an original online , interactive smoking cessation program or to a modified program . Both programs consisted of tailored , personalized counseling letters based on participants ' characteristics , followed by monthly email reminders . The original program was based on psychological and addiction theory , and on preliminary research conducted in the same population . The modified program was shorter and contained more information on nicotine replacement therapy and nicotine dependence , and less information on health risks and coping strategies . In both programs , 1 month and 2 months after entering the study , participants were invited by email to answer the same tailoring question naire again in order to receive a second counseling letter . Participants in both programs obtained , on average , 1.2 feedback counseling letters over 2.5 months , and 84 % received only 1 feedback letter . The outcome was self-reported smoking abstinence ( no puff of tobacco in the previous 7 days ) , assessed 2.5 months after entry in the program . We report results from intention-to-treat ( ITT ) analyses , where all non-respondents at follow-up were counted as smokers . Results The baseline question naire was answered by a total of 11969 current ( 74 % ) and former ( 26 % ) smokers , and the follow-up survey by 4237 people ( 35 % ) . In an ITT analysis , abstinence rates in baseline current smokers were respectively 10.9 % and 8.9 % ( odds ratio [OR]=1.24 , 95 % confidence interval [CI]1.08 - 1.43 , P=.003 ) in the original and modified programs , and 25.2 % and 15.7 % ( OR=1.81 , CI 1.51 - 2.16 , P<.001 ) in baseline former smokers . While we found statistically significant differences in quit rates in smokers in the contemplation stage favoring the original program ( OR=1.54 , CI 1.18 - 2.02 , P=.002 ) , no between-group differences in quit rates were observed in smokers in the precontemplation ( OR=1.07 , CI 0.36 - 3.14 , P=.91 ) and preparation ( OR=1.15 , CI 0.97 - 1.37 , P=.10 ) stages of change . Conclusions In smokers in the contemplation stage of change and in former smokers , the original program produced higher smoking abstinence rates than the modified program OBJECT
Output:
| CONCLUSION Internet interventions are superior to other broad reach cessation interventions ( ie , print material s ) , equivalent to other currently recommended treatment modes ( telephone and in-person counseling ) , and they have an important role to play in the arsenal of tobacco-dependence treatments |
MS213986 | ***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 The aim of this study was to evaluate the effect of different surface treatments : s and blasting , liners , and different laser irradiations on shear bond strength ( SBS ) of pre-sintered zirconia to veneer ceramic . BACKGROUND DATA The SBS between veneering porcelain and zirconium oxide ( ZrO2 ) substructure was weak . Various surface treatment methods have been suggested for zirconia to obtain high bond strength to veneering porcelain . There is no study that evaluated the bond strength between veneering porcelain and the different surface treatments on pre-sintered ZrO2 substructure . METHODS Two hundred specimens with 7 mm diameter and 3 mm height pre-sintered zirconia blocks were fabricated . Specimens were r and omly divided into 10 groups ( n=20 ) according to surface treatments applied . Group C , untreated ( Control ) ; Group E , erbium : yttrium-aluminum-garnet ( Er : YAG ) laser irradiated ; Group N , neodymium : yttrium-aluminum-garnet ( Nd : YAG ) laser irradiated ; Group SB , s and blasted ; Group L , liner applied ; Group NL , Nd : YAG laser irradiated+liner applied ; Group EL , Er : YAG laser irradiated+liner applied ; Group SN , s and blasted+Nd : YAG laser irradiated ; Group SE , s and blasted+Er : YAG laser irradiated ; and Group SL , s and blasted+liner applied . The disks were then veneered with veneering porcelain . Before the experiment , specimens were steeped in 37 ° C distilled water for 24 h. All specimens were thermocycled for 5000 cycles between 5 ° C and 55 ° C with a 30 sec dwell time . Shear bond strength test was performed at a crosshead speed of 1 mm/min . The fractured specimens were examined under a stereomicroscope to evaluate the fracture pattern . RESULTS Surface treatments significantly changing the topography of the yttrium-stabilized tetragonal zirconia ( Y-TZP ) ceramic according to scanning electron microscopic ( SEM ) images . The highest mean bond strength value was obtained in Group SE , and the lowest bond strength value was observed in NL group . Bond strength values of the other groups were similar to each other . CONCLUSIONS This study shows that s and blasting+Er : YAG , s and blasting , Er : YAG+liner , s and blasting+Nd : YAG , and Er : YAG laser treatment on pre-sintered ZrO2 substructure increased the bond strength to veneering porcelain , compared with other surface treatments . After different surface treatments , there was no difference in surface roughness of pre-sintered zirconia to compare after sintering ; sintering enhanced the bond strength within the limitations of present study OBJECTIVE This study investigated the mechanism of action at the interface between a commercially available Y-TZP and its veneering ceramic after final firing . Particular attention was paid , from a microstructural point of view , to evaluating the effects of different surface treatments carried out on the zirconia . METHODS In total , 32 specimens of presintered zirconia Y-TZP ( LavaFrame , 3 M ESPE , Germany ) were cut with a low-speed diamond blade . The specimens were divided in two major groups , for testing after fracture or after mirror finishing , and were sintered following the manufacturer 's instructions . Each major group was then r and omly divided into four subgroups , according to using or not using the dedicated framework modifier , with or without a preliminary silica coating ( CoJet , 3 M ESPE ) . A suitable veneering ceramic was used for each group ( Lava Ceram Overlay Porcelain , 3 M ESPE ) . A detailed microstructural study of the interfaces of the zirconia-veneering ceramic was performed using a scanning electron microscope equipped with an energy-dispersive X-ray spectrometer to evaluate chemical variation at the interfaces . RESULTS When the framework modifier was not applied on the Y-TZP surface , microdetachments , porosities , and openings in the ceramic layer were observed at the interlayers . A degree of diffusion of different elements through the interfaces from both the zirconia and veneering layers was detected . CONCLUSIONS Application of the framework modifier can increase the wettability of the zirconia surfaces , allowing a continuous contact with the veneering layer . The micro- analysis performed showed the presence of a reaction area at the interface between the different material s. CLINICAL SIGNIFICANCE the increase of the wettability of the zirconia surface could improve the adhesion at interface with the veneering ceramic and reduce the clinical failure as chipping or delamination OBJECTIVES The aim of this study was to compare the effects of three different surface treatments in enhancing porcelain zirconia bonding . METHODS Totally , 160 densely sintered zirconia specimens were prepared and r and omly divided into four study groups : control ( no treatment , Group C ) , s and blasting ( Group S ) , s and blasting followed by regeneration firing ( Group SH ) , and laser irradiation ( pulse mode ) on a CO₂ laser system ( Group L ) . After surface treatment , porcelain powders were veneered on zirconia surface . Half of the specimens in each group were evaluated without aging ( initial shear bond strength - initial SBS ) , and the other half was tested after being stored in water for one month ( aging SBS ) . X-ray diffractometry ( XRD ) was used to observe any crystallographic transformation at zirconia surface . Results were statistically analyzed using analysis of variance ( ANOVA ) and Turkey test ( = 0.05 ) . RESULTS The initial average SBS values of Group S , Group SH , and Group L were 31.3 ± 5.7 MPa , 29.2 ± 7.0 MPa and 32.1 ± 7.5 MPa , respectively . The differences among these three groups were not significant . The control group had significantly lower value , 24.8 ± 6.7 MPa , than those of Group S and Group L. Furthermore , there was no significant difference between initial and aging values in each group . XRD analysis showed that s and blasting caused tetragonal to monoclinic phase transformation . Regeneration firing reversed such a transformation . However , crystallographic transformation could not be detected in laser treated specimens . SIGNIFICANCE Both s and blasting and laser irradiation increased porcelain zirconia bond strength . The presented new modified laser pre-treatment might be an alternative way to s and blasting for improving zirconia/porcelain integration
Output:
| Surface treatment in Y-TZP improved the values of SBS between the Y-TZP and veneer ceramic .
The associations between two or more treatments also showed positive effect on the bond strength due the cumulative effect of the treatments |
MS213987 | ***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 To perform a r and omized trial comparing 70 and 80 Gy radiotherapy for prostate cancer . PATIENTS AND METHODS A total of 306 patients with localized prostate cancer were r and omized . No and rogen deprivation was allowed . The primary endpoint was biochemical relapse according to the modified 1997-American Society for Therapeutic Radiology and Oncology and Phoenix definitions . Toxicity was grade d using the Radiation Therapy Oncology Group 1991 criteria and the late effects on normal tissues-subjective , objective , management , analytic scales ( LENT-SOMA ) scales . The patients ' quality of life was scored using the European Organization for Research and Treatment of Cancer Quality of Life Question naire 30-item cancer-specific and 25-item prostate-specific modules . RESULTS The median follow-up was 61 months . According to the 1997-American Society for Therapeutic Radiology and Oncology definition , the 5-year biochemical relapse rate was 39 % and 28 % in the 70- and 80-Gy arms , respectively ( p = .036 ) . Using the Phoenix definition , the 5-year biochemical relapse rate was 32 % and 23.5 % , respectively ( p = .09 ) . The subgroup analysis showed a better biochemical outcome for the higher dose group with an initial prostate-specific antigen level > 15 ng/mL. At the last follow-up date , 26 patients had died , 10 of their disease and none of toxicity , with no differences between the two arms . According to the Radiation Therapy Oncology Group scale , the Grade 2 or greater rectal toxicity rate was 14 % and 19.5 % for the 70- and 80-Gy arms ( p = .22 ) , respectively . The Grade 2 or greater urinary toxicity was 10 % at 70 Gy and 17.5 % at 80 Gy ( p = .046 ) . Similar results were observed using the LENT-SOMA scale . Bladder toxicity was more frequent at 80 Gy than at 70 Gy ( p = .039 ) . The quality -of-life question naire results before and 5 years after treatment were available for 103 patients with no differences found between the 70- and 80-Gy arms . CONCLUSION High-dose radiotherapy provided a better 5-year biochemical outcome with slightly greater toxicity Background To evaluate the daily total error shift patterns on post-prostatectomy patients undergoing image guided radiotherapy ( IGRT ) with a diagnostic quality computer tomography ( CT ) on rails system . Methods A total of 17 consecutive post-prostatectomy patients receiving adjuvant or salvage IMRT using CT-on-rails IGRT were analyzed . The prostate bed 's daily total error shifts were evaluated for a total of 661 CT scans . Results In the right-left , cranial-caudal , and posterior-anterior directions , 11.5 % , 9.2 % , and 6.5 % of the 661 scans required no position adjustments ; 75.3 % , 66.1 % , and 56.8 % required a shift of 1 - 5 mm ; 11.5 % , 20.9 % , and 31.2 % required a shift of 6 - 10 mm ; and 1.7 % , 3.8 % , and 5.5 % required a shift of more than 10 mm , respectively . There was evidence of correlation between the x and y , x and z , and y and z axes in 3 , 3 , and 3 of 17 patients , respectively . Univariate ( ANOVA ) analysis showed that the total error pattern was r and om in the x , y , and z axis for 10 , 5 , and 2 of 17 patients , respectively , and systematic for the rest . Multivariate ( MANOVA ) analysis showed that the ( x , y ) , ( x , z ) , ( y , z ) , and ( x , y , z ) total error pattern was r and om in 5 , 1 , 1 , and 1 of 17 patients , respectively , and systematic for the rest . Conclusions The overall daily total error shift pattern for these 17 patients simulated with an empty bladder , and treated with CT on rails IGRT was predominantly systematic . Despite this , the temporal vector trends showed complex behaviors and unpredictable changes in magnitude and direction . These findings highlight the importance of using daily IGRT in post-prostatectomy patients The National Cancer Institute of Canada ( NCIC ) Clinical Trials Group PR.3/Medical Research Council PR07/ Intergroup T94 - 0110 ( 1 ) was a r and omized controlled trial ( RCT ) of radiation therapy ( RT ) and and rogen deprivation therapy ( ADT ) vs. ADT alone , for men with locally advanced prostate cancer . The authors defined locally advanced as : ( I ) T3 - 4 , N0/X , M0 ; or ( II ) T1 - 2 with prostate specific antigen ( PSA ) > 40 ng/mL ; or ( III ) PSA 20 - 40 ng/mL and Gleason 8 - 10 . Men were r and omized to lifelong ADT vs. ADT + RT , 65 - 69 Gy in 1.8 Gy fractions , using 3D conformal RT , to the prostate and pelvis or prostate alone . Of the 1,205 patients treated between 1995 and 2005 , 602 received ADT alone and 603 received ADT + RT . Overall survival ( OS ) was significantly improved in the patients allocated to ADT + RT [ hazard ratio ( HR ) = 0.70 ; 95 % CI , 0.57 - 0.85 ; P<0.001 ] . Prostate cancer specific mortality ( CSM ) was improved in the patients allocated to ADT + RT ( HR = 0.46 ; 95 % CI , 0.34 - 0.61 ; P<0.001 ) . Although patients on ADT + RT arm reported a higher rate of gastrointestinal ( GI ) toxicity , only 2 of 589 patients had grade 3 or greater diarrhea at 24 months after RT Objectives : Freedom from biochemical failure ( FFBF ) is a common primary outcome of r and omized-controlled trials of prostate cancer ( PCa ) . We aim ed to determine how increasing the PCa biologically equivalent dose ( BED ) of external radiation therapy ( RT ) is correlated with FFBF and overall patient outcomes : overall survival ( OS ) , distant metastasis ( DM ) , and cancer-specific mortality ( CSM ) ; as well as genitourinary ( GU ) , and gastrointestinal toxicities . Material s and Methods : We performed a meta- analysis of 6884 PCa patients from 12 r and omized-controlled trials of external beam RT . Mixed effects regression models were used to estimate weighted linear relationships between BED and observed percentages of 5- and 10-year outcomes . For toxicities , a subset analysis of using 3-dimensional conformal RT ( 3D-CRT ) versus intensity-modulated RT ( IMRT ) was performed . Results : Increasing BED correlated with improved FFBF : 10-year absolute improvement of 9.6 % and 7.2 % for low-risk and intermediate-risk patients , respectively ( P<0.05 ) ; but not with improvement of OS , DM , or CSM at either time point . BED escalation was not correlated with increased acute toxicities ; it was correlated with increased late gastrointestinal toxicities in patients treated with 3D-CRT ( 1.5 % increase over BED range , P<0.01 ) . IMRT patients had significantly fewer late toxicities , despite being treated at higher BED . Conclusions : RT BED escalation has result ed in significantly improved PCa FFBF at up to 10 years ; but not with improvement in OS , DM , or CSM . Thus , FFBF is a poor surrogate of overall patient outcomes for trials of RT . Late toxicities were less frequent with IMRT than with 3D-CRT , even at higher BED Objectives : Stereotactic body radiation therapy ( SBRT ) takes advantage of the prostate ’s low α/β ratio to deliver a large radiation dose in few fractions . Initial studies on small groups of low-risk patients support SBRT ’s potential for clinical efficacy while limiting treatment-related morbidity and maintained quality of life . This prospect i ve study exp and s upon prior studies to further evaluate SBRT efficacy for a large patient population with organ confined , low- and intermediate-risk prostate cancer patients . Methods : Four hundred seventy-seven patients with prostate cancer received CyberKnife SBRT . The median age was 68.6 years and the median PSA was 5.3 ng/mL. Three hundred twenty-four patients were low-risk ( PSA < 10 ng/mL and Gleason < 7 ) , 153 were intermediate-risk ( PSA 10–20 ng/mL or Gleason = 7 ) . And rogen deprivation therapy was administered to 51 patients for up to 6 months . One hundred fifty-four patients received 35 Gy delivered in five daily fractions ; the remaining patients received a total dose of 36.25 Gy in five daily fractions . Biochemical failure was assessed using the phoenix criterion . Results : Median follow-up was 72 months . The median PSA at 7 years was 0.11 ng/mL. Biochemical failures occurred for 11 low-risk patients ( 2 locally ) , 14 intermediate-risk patients ( 3 locally ) . The actuarial 7-year freedom from biochemical failure was 95.6 and 89.6 % for low- and intermediate-risk groups , respectively ( p < 0.012 ) . Among patients with intermediate-risk disease , those considered to have low intermediate-risk ( Gleason 6 with PSA > 10 , or Gleason 3 + 4 with PSA < 10 ; n = 106 ) had a significantly higher bDFS than patients with high intermediate-risk ( Gleason 3 + 4 with PSA 10–20 or Gleason 4 + 3 ; n = 47 ) , with bDFS of 93.5 vs. 79.3 % , respectively . For the low-risk and low intermediate-risk groups , there was no difference in median PSA nadir or biochemical disease control between doses of 35 and 36.25 Gy . Conclusion : CyberKnife SBRT produces excellent biochemical control rates . Median PSA levels compare favorably with other radiation modalities and strongly suggest durability of response . These results also strongly suggest that 35 Gy is as effective as 36.25 Gy for low- and intermediate-risk patients PURPOSE Hypofractionated radiotherapy has an intrinsically different normal tissue and tumor radiobiology . The results of a prospect i ve trial of stereotactic body radiotherapy ( SBRT ) for prostate cancer with long-term patient-reported toxicity and tumor control rates are presented . METHODS AND MATERIAL S From 2003 through 2009 , 67 patients with clinical ly localized low-risk prostate cancer were enrolled . Treatment consisted of 36.25 Gy in 5 fractions using SBRT with the CyberKnife as the delivery technology . No patient received hormone therapy . Patient self-reported bladder and rectal toxicities were grade d on the Radiation Therapy Oncology Group scale ( RTOG ) . RESULTS Median follow-up was 2.7 years . There were no grade 4 toxicities . Radiation Therapy Oncology Group Grade 3 , 2 , and 1 bladder toxicities were seen in 3 % ( 2 patients ) , 5 % ( 3 patients ) , and 23 % ( 13 patients ) respectively . Dysuria exacerbated by urologic instrumentation accounted for both patients with Grade 3 toxicity . Urinary incontinence , complete obstruction , or persistent hematuria was not observed . Rectal Grade 3 , 2 , and 1 toxicities were seen in 0 , 2 % ( 1 patient ) , and 12.5 % ( 7 patients ) , respectively . Persistent rectal bleeding was not observed . Low- grade toxicities were substantially less frequent with QOD vs. QD dose regimen ( p = 0.001 for gastrointestinal and p = 0.007 for genitourinary ) . There were two prostate-specific antigen ( PSA ) , biopsy-proven failures with negative metastatic workup . Median PSA at follow-up was 0.5 ± 0.72 ng/mL. The 4-year Kaplan-Meier PSA relapse-free survival was 94 % ( 95 % confidence interval , 85%-102 % ) . CONCLUSION Significant late bladder and rectal toxicities from SBRT for prostate cancer are infrequent . PSA relapse-free survival compares favorably with other definitive treatments . The current evidence supports consideration of stereotactic body radiotherapy among the therapeutic options for localized prostate cancer PURPOSE Report of clinical cancer control outcomes on Radiation Therapy Oncology Group ( RTOG ) 9406 , a three-dimensional conformal radiation therapy ( 3D-CRT ) dose escalation trial for localized adenocarcinoma of the prostate . METHODS AND MATERIAL S RTOG 9406 is a Phase I/II multi-institutional dose escalation study of 3D-CRT for men with localized prostate cancer . Patients were registered on five sequential dose levels : 68.4 Gy , 73.8 Gy , 79.2
Output:
| The data for SBRT show encouraging and comparable results in terms of freedom from biochemical failure ( > 90 % for low and intermediate risk at 5 - 7 years ) and acute and late toxicity ( < 6 % grade 3 - 4 late toxicities ) .
At this time , neither SBRT device is recommended over the other for all patients ; however , gantry-based SBRT machines have the abilities of treating larger volumes with conventional fractionation , shorter treatment time per fraction ( ~15 minutes for gantry vs ~45 minutes for robotic arm ) , and the ability to achieve better plans among obese patients ( since they are able to use energies > 6 MV ) .
Finally , SBRT ( particularly on a gantry ) may also be more cost-effective than conventionally fractionated external-beam radiation therapy . |
MS213988 | ***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 Chemoimmunotherapy with fludarabine , cyclophosphamide , and rituximab is the st and ard therapy for physically fit patients with advanced chronic lymphocytic leukaemia . This international phase 3 study compared the efficacy and tolerance of the st and ard therapy with a potentially less toxic combination consisting of bendamustine and rituximab . METHODS Treatment-naive fit patients with chronic lymphocytic leukaemia ( aged 33 - 81 years ) without del(17p ) were enrolled after undergoing a central screening process . Patients were r and omly assigned ( 1:1 ) with a computer-generated r and omisation list using r and omly permuted blocks with a block size of eight and were stratified according to participating country and Binet stage . Patients were allocated to receive six cycles of intravenous fludarabine ( 25 mg/m(2 ) per day ) and cyclophosphamide ( 250 mg/m(2 ) per day ) for the first 3 days or to intravenous bendamustine ( 90 mg/m(2 ) per day ) for the first 2 days of each cycle . Rituximab 375 mg/m(2 ) was given intravenously in both groups on day 0 of cycle 1 and subsequently was given at 500 mg/m(2 ) during the next five cycles on day 1 . The primary endpoint was progression-free survival with the objective to assess non-inferiority of bendamustine and rituximab to the st and ard therapy . We aim ed to show that the 2-year progression-free survival with bendamustine and rituximab was not 67·5 % or less with a corresponding non-inferiority margin of 1·388 for the hazard ratio ( HR ) based on the 90·4 % CI . The final analysis was done by intention to treat . The study is registered with Clinical Trials.gov , number NCT%2000769522 . FINDINGS 688 patients were recruited between Oct 2 , 2008 , and July 11 , 2011 , of which 564 patients who met inclusion criteria were r and omly assigned . 561 patients were included in the intention-to-treat population : 282 patients in the fludarabine , cyclophosphamide , and rituximab group and 279 in the bendamustine and rituximab group . After a median observation time of 37·1 months ( IQR 31·0 - 45·5 ) median progression-free survival was 41·7 months ( 95 % CI 34·9 - 45·3 ) with bendamustine and rituximab and 55·2 months ( 95 % CI not evaluable ) with fludarabine , cyclophosphamide , and rituximab ( HR 1·643 , 90·4 % CI 1·308 - 2·064 ) . As the upper limit of the 90·4 % CI was greater than 1·388 the null hypothesis for the corresponding non-inferiority hypothesis was not rejected . Severe neutropenia and infections were more frequently observed with fludarabine , cyclophosphamide , and rituximab ( 235 [ 84 % ] of 279 vs 164 [ 59 % ] of 278 , and 109 [ 39 % ] vs 69 [ 25 % ] , respectively ) during the study . The increased frequency of infectious complications with fludarabine , cyclophosphamide , and rituximab was more pronounced in patients older than 65 years . INTERPRETATION The combination of fludarabine , cyclophosphamide , and rituximab remains the st and ard front-line therapy in fit patients with chronic lymphocytic leukaemia , but bendamustine and rituximab is associated with less toxic effects . FUNDING Roche Pharma AG , Mundipharma , German Federal Ministry of Education and Research Summary Background Uncontrolled studies comparing pentostatin ( P ) , cyclophosphamide ( C ) , and rituximab ( R ) ( PCR ) to fludarabine plus C+R ( FCR ) suggest similar efficacy with fewer infectious complications with PCR . We compared FCR and PCR in previously-untreated or minimally-treated B-cell chronic lymphocytic leukemia ( CLL ) . Treatment FCR ( F 20 mg/m2 Days 1–5 , C 600 mg/m2 Day 1 , R 375 mg/m2 Day 1 ) ( 28-day cycles ) or PCR ( P 4 mg/m2 Day 1 , C 600 mg/m2 Day 1 , R 375 mg/m2 Day 1 ) ( 21-day cycles ) . Dose 1 of R : 100 mg/m2 was given on Day 8 Cycle 1 and the remainder on Day 9 ; in subsequent cycles the entire dose was given on Day 1 . Results Ninety-two patients were r and omly assigned to each group ( N = 184 ) . Groups were balanced ; ~20 % had received prior chemotherapy . The infection rate ( FCR/PCR ) was 31%/36 % , the infective event rate was 38%/45 % ; 30 (35%)/37 ( 44 % ) patients were hospitalized ; total hospitalization days was 271/404 . 12 (14%)/6 ( 7 % ) patients achieved complete remissions ( CR ) ; the overall response rate ( ORR ) including CR+nodular PR (nPR)+PR was 59%/49 % . Grade 3–4 treatment related AEs : neutropenia ( 69%/57 % ) , leukopenia ( 34%/17 % ) , thrombocytopenia ( 13%/6 % ) . Grade 3–4 infections : febrile neutropenia ( 8%/6 % ) , fever ( 2%/6 % ) , infection ( 1%/3 % ) , urinary tract infection ( 1%/0 % ) , pneumonia ( 3%/1 % ) , and sepsis ( 1%/2 % ) ; 5 deaths ( 1 FCR/4 PCR ) were treatment-related . Conclusions PCR and FCR have significant activity in CLL and can be given safely in the community setting despite significant toxicity . ORRs were lower than expected ; the CR rate was higher ( NS ) with FCR . This trial did not demonstrate a lower infection rate with PCR The high complete remission rate with first-line combined fludarabine , cyclophosphamide , and rituximab ( FCR ) begs the question of the value of minimal residual disease (MRD)-negative status as a treatment end point . We report on 237 patients with chronic lymphocytic leukemia who received first-line FCR . MRD was prospect ively assessed by 4-color flow cytometry in bone marrow after course 3 and at final response assessment . After course 3 and at final response assessment , 17 % and 43 % of patients were MRD negative in bone marrow , respectively . A mutated immunoglobulin heavy chain variable gene and trisomy 12 were independently associated with MRD-negative status both after 3 courses of FCR and at final response assessment in multivariable analyses ( MVAs ) . MRD-negative status was independently associated with significantly longer progression-free survival ( PFS ) and overall survival ( OS ) in MVA ( P = .03 and .02 , respectively ) . This association was confirmed also on l and mark MVA at the time of MRD assessment ( P = .04 and .05 , respectively ) . MRD-negative patients had comparable PFS and OS , independent of the number of courses received or interim staging . Early MRD eradication may be a desirable goal , prompting consideration of early discontinuation of treatment . This trial was registered at www . clinical trials.gov as # NCT00759798 BACKGROUND Chronic lymphocytic leukemia ( CLL ) primarily affects older persons who often have coexisting conditions in addition to disease-related immunosuppression and myelosuppression . We conducted an international , open-label , r and omized phase 3 trial to compare two oral agents , ibrutinib and chlorambucil , in previously untreated older patients with CLL or small lymphocytic lymphoma . METHODS We r and omly assigned 269 previously untreated patients who were 65 years of age or older and had CLL or small lymphocytic lymphoma to receive ibrutinib or chlorambucil . The primary end point was progression-free survival as assessed by an independent review committee . RESULTS The median age of the patients was 73 years . During a median follow-up period of 18.4 months , ibrutinib result ed in significantly longer progression-free survival than did chlorambucil ( median , not reached vs. 18.9 months ) , with a risk of progression or death that was 84 % lower with ibrutinib than that with chlorambucil ( hazard ratio , 0.16 ; P<0.001 ) . Ibrutinib significantly prolonged overall survival ; the estimated survival rate at 24 months was 98 % with ibrutinib versus 85 % with chlorambucil , with a relative risk of death that was 84 % lower in the ibrutinib group than in the chlorambucil group ( hazard ratio , 0.16 ; P=0.001 ) . The overall response rate was higher with ibrutinib than with chlorambucil ( 86 % vs. 35 % , P<0.001 ) . The rates of sustained increases from baseline values in the hemoglobin and platelet levels were higher with ibrutinib . Adverse events of any grade that occurred in at least 20 % of the patients receiving ibrutinib included diarrhea , fatigue , cough , and nausea ; adverse events occurring in at least 20 % of those receiving chlorambucil included nausea , fatigue , neutropenia , anemia , and vomiting . In the ibrutinib group , four patients had a grade 3 hemorrhage and one had a grade 4 hemorrhage . A total of 87 % of the patients in the ibrutinib group are continuing to take ibrutinib . CONCLUSIONS Ibrutinib was superior to chlorambucil in previously untreated patients with CLL or small lymphocytic lymphoma , as assessed by progression-free survival , overall survival , response rate , and improvement in hematologic variables . ( Funded by Pharmacyclics and others ; RESONATE-2 Clinical Trials.gov number , NCT01722487 . ) Despite promising results with targeted drugs , chemoimmunotherapy with fludarabine , cyclophosphamide ( FC ) , and rituximab ( R ) remains the st and ard therapy for fit patients with untreated chronic lymphocytic leukemia ( CLL ) . Herein , we present the long-term follow-up of the r and omized CLL8 trial reporting safety and efficacy of FC and FCR treatment of 817 treatment-naïve patients with CLL . The primary end point was progression-free survival ( PFS ) . With a median follow-up of 5.9 years , median PFS were 56.8 and 32.9 months for the FCR and FC group ( hazard ratio [ HR ] , 0.59 ; 95 % confidence interval [ CI ] , 0.50 - 0.69 , P < .001 ) . Median overall survival ( OS ) was not reached for the FCR group and was 86.0 months for the FC group ( HR , 0.68 ; 95 % CI , 0.54 - 0.89 , P = .001 ) . In patients with mutated IGHV ( IGHV MUT ) , FCR improved PFS and OS compared with FC ( PFS : HR , 0.47 ; 95 % CI , 0.33 - 0.68 , P < .001 ; OS : HR , 0.62 ; 95 % CI , 0.34 - 1.11 , P = .1 ) . This improvement remained applicable for all cytogenetic subgroups other than del(17p ) . Long-term safety analyses showed that FCR had a higher rate of prolonged neutropenia during the first year after treatment ( 16.6 % vs 8.8 % ; P = .007 ) . Secondary malignancies including Richter 's transformation occurred in 13.1 % in the FCR group and in 17.4 % in the FC group ( P = .1 ) . First-line chemoimmunotherapy with FCR induces long-term remissions and highly relevant improvement in OS in specific genetic subgroups of fit patients with CLL , in particular those with IGHV MUT . This trial was registered at www . clinical trials.gov as # NCT00281918 Background The results of R and omized Controlled Trials ( RCTs ) on time-to-event outcomes that are usually reported are median time to events and Cox Hazard Ratio . These do not constitute the sufficient statistics required for meta- analysis or cost-effectiveness analysis , and their use in secondary analyses requires strong assumptions that may not have been adequately tested . In order to enhance the quality of secondary data analyses , we propose a method which derives from the published Kaplan Meier survival curves a close approximation to the original individual patient time-to-event data from which they were generated . Methods We develop an algorithm that maps from digitised curves back to KM data by finding numerical solutions to the inverted KM equations , using where available information on number of
Output:
| FCR improved complete remission , PFS and overall survival vs the comparator ; median PFS was not reached in the subgroup of CLL patients with mutated IGHV |
MS213989 | ***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: & NA ; Physical therapists seeking to use evidence to guide their practice may have limited time to read research reports . One way to reduce the time required to identify and read about the research that is relevant to a particular clinical question is to read a systematic review that summarizes multiple studies . This paper explains the process that is used to conduct systematic review s , which includes the establishment of a protocol , comprehensive search ing , appraisal of the quality of the included studies , data extraction and meta analysis , and consideration of the clinical and research implication s of the findings . We also consider how the reader of a systematic review can determine whether the review is likely to provide an unbiased ( believable ) estimate of the treatment effect . A systematic review of r and omized trials of a cardiopulmonary physical therapy intervention is used as an example . The issue of appraisal of quality is then discussed further , with a demonstration of how one vali date d tool for quality appraisal ‐‐the PEDro scale‐‐can be used to evaluate a r and omized trial in cardiopulmonary physical therapy Rheumatoid arthritis ( RA ) is a systemic inflammatory and chronic disease of joints , which may result in irreversible deformities . To evaluate the effects of an exercise programme aim ed at improving the h and strength in individuals with h and deformities result ing from RA and to analyse the impact these exercises have on functionality . Twenty women with RA h and deformities participated in the study . They were r and omly divided into two groups as follows : Group 1 ( n = 13 ) had women participating in the exercise programme aim ed at improving h and grip ( HS ) and pinch strengths ( PS ) as well as the motor coordination of the h and ; Group 2 ( n = 7 ) had women with RA who received no treatment for their h and s ( control ) . The treatment programme for h and s consisted of 20 sessions , twice a week and at-home exercises . Both groups were su bmi tted to Health Assessment Question naire ( HAQ ) and evaluation of HS and PS by means of dynamometry . Re-evaluations were performed after 10 and 20 sessions in Group 1 and after 2 months in Group 2 . After 20 sessions of physiotherapy , Group 1 had a significant gain in HS and PS ( p < 0.05 ) in addition to the improvement of functionality as assessed by HAQ ( p = 0.016 ) . For Group 2 , no difference was found between the variables analysed ( p > 0.05 ) . The strengthening exercises for individuals with RA h and deformity are beneficial to improve h and grip and pinch strengths as well as functionality OBJECTIVE To investigate the effect of long term high intensity weightbearing exercises on radiological damage of the joints of the h and s and feet in patients with rheumatoid arthritis ( RA ) . METHODS Data of the 281 completers of a 2 year r and omised controlled trial comparing the effects of usual care physical therapy ( UC ) with high intensity weightbearing exercises were analysed for the rate of radiological joint damage ( Larsen score ) of the h and s and feet . Potential determinants of outcome were defined : disease activity , use of drugs , change in physical capacity and in bone mineral density , and attendance rate at exercise sessions . RESULTS After 2 years , the 136 participants in high intensity weightbearing exercises developed significantly less radiological damage than the 145 participants in UC . The mean ( SD ) increase in damage was 3.5 ( 7.9 ) in the exercise group and 5.7 ( 10.2 ) in the UC group , p = 0.045 . Separate analysis of the damage to the h and s and feet suggests that this difference in rate of increase of damage is more pronounced in the joints of the feet than in the h and s. The rate of damage was independently associated with less disease activity , less frequent use of glucocorticoids , and with an improvement in aerobic fitness . CONCLUSION The progression of radiological joint damage of the h and s and feet in patients with RA is not increased by long term high intensity weightbearing exercises . These exercises may have a protective effect on the joints of the feet OBJECTIVE To investigate the effects of a 21-week concurrent strength and endurance training protocol on physical fitness profile in women with early or longst and ing rheumatoid arthritis ( RA ) compared with healthy subjects . METHODS Twenty-three female patients with RA volunteered for the study . Twelve had early RA and eleven had longst and ing RA . Twelve healthy women served as controls . Maximal strength of different muscle groups was measured by dynamometers , walking speed with light cells , and vertical squat jump on the force platform to mirror explosive force . Maximal oxygen uptake was measured by gas analyzer . Six training sessions ( 3 strength training and 3 endurance training ) were carried out in a 2-week period for 21 weeks . RESULTS The training led to large gains in maximal strength both in women with RA and in healthy women ( P < 0.043 - 0.001 ) . The strength gains were accompanied by increases in walking speed ( P < 0.034 - 0.001 ) and vertical squat jump ( P < 0.034 - 0.001 ) . Significant improvements also occurred in maximal aerobic capacity in all groups ( P < 0.023 - 0.014 ) . CONCLUSIONS Both early and longst and ing RA patients with stable disease can safely improve all characteristics of their physical fitness profile using a progressive concurrent strength and endurance training protocol OBJECTIVE To evaluate the effectiveness of three different physiotherapeutic approaches in the management of the rheumatoid h and . METHODS In a r and omized controlled trial , participants with rheumatoid arthritis ( RA ) recruited from a rheumatology department in Mid-Staffordshire , UK ( February 1999 to January 2001 ) were r and omized to three groups . All received joint protection ( JP ) information delivered by a therapist at baseline . Group 1 participants received a set of additional h and -strengthening and mobilizing home exercises , group 2 a different set of additional h and -stretching exercises and group 3 the JP information alone . The primary outcome was the Arthritis Impact Measurement Scales II ( AIMS II ) ( upper limb ; h and and finger function subscales ) . Outcomes were assessed at baseline and 1 , 3 and 6 months . Analysis was by intention to treat . RESULTS Sixty-seven participants ( mean age 59.6 yr ) were recruited : group 1 n = 21 , group 2 n = 24 and group 3 n = 22 . A 78 % follow-up was achieved at 6 months . There was a mean fall ( SD ) in AIMS II upper limb function 0 - 6 month change scores in group 1 of 1.00 ( 1.07 ) . In groups 2 and 3 there was a mean increase in AIMS II scores of 0.18 ( 1.54 ) and 0.30 ( 1.22 ) , respectively . The differences in AIMS change scores between group 1 and groups 2 and 3 were statistically significant ( P = 0.007 ) and remained so after adjustment for multiple testing ( P = 0.012 ) . CONCLUSION Statistically significant improvements in arm function have been demonstrated following a programme of home-strengthening h and exercises in RA patients compared with simple stretches or advice alone BACKGROUND AND PURPOSE Assessment of the quality of r and omized controlled trials ( RCTs ) is common practice in systematic review s. However , the reliability of data obtained with most quality assessment scales has not been established . This report describes 2 studies design ed to investigate the reliability of data obtained with the Physiotherapy Evidence Data base ( PEDro ) scale developed to rate the quality of RCTs evaluating physical therapist interventions . METHOD In the first study , 11 raters independently rated 25 RCTs r and omly selected from the PEDro data base . In the second study , 2 raters rated 120 RCTs r and omly selected from the PEDro data base , and disagreements were resolved by a third rater ; this generated a set of individual rater and consensus ratings . The process was repeated by independent raters to create a second set of individual and consensus ratings . Reliability of ratings of PEDro scale items was calculated using multirater kappas , and reliability of the total ( summed ) score was calculated using intraclass correlation coefficients ( ICC [ 1,1 ] ) . RESULTS The kappa value for each of the 11 items ranged from.36 to.80 for individual assessors and from.50 to.79 for consensus ratings generated by groups of 2 or 3 raters . The ICC for the total score was.56 ( 95 % confidence interval=.47-.65 ) for ratings by individuals , and the ICC for consensus ratings was.68 ( 95 % confidence interval=.57-.76 ) . DISCUSSION AND CONCLUSION The reliability of ratings of PEDro scale items varied from " fair " to " substantial , " and the reliability of the total PEDro score was " fair " to " good . A series of experiments showed that , on exercise of the inflamed human knee , intra-articular pressure rises above synovial capillary perfusion pressure , causing intra-articular hypoxia ; and that , on cessation of exercise , there is oxidative damage to lipids and IgG within the joint . These findings are consistent with the hypothesis that persistence of synovial inflammation can be due to exercise-induced hypoxic-reperfusion injury mediated by reactive oxygen species The primary objective of our study was to evaluate the effect of 6-week-long isotonic and isometric h and exercises on pain , h and functions , dexterity and quality of life in women diagnosed as rheumatoid arthritis ( RA ) . Our secondary objective was to assess the changes in h and grip strength and disease activity . This r and omized , parallel , single-blinded 6-week intervention study enrolled 52 female patients between 40 and 70 years of age , who were diagnosed with RA according to American College of Rheumatology criteria , had disease duration of at least 1 year and had a stage 1–3 disease according to Steinbrocker ’s functional evaluation scale . Patients were r and omized into isotonics and isometrics groups . Exercises were performed on sixth week . All patients were applied wax therapy in the first 2 weeks . Their pain was assessed with visual analog scale ( VAS ) , their h and functions with Duruöz H and Index ( DHI ) , dexterity with nine hole peg test ( NHPT ) and quality of life with Rheumatoid Arthritis Quality of Life question naire ( RAQoL ) . Dominant and non-dominant h and grip strengths ( HS ) were measured . Disease activity was determined by disease activity score ( DAS 28 ) . We evaluated the difference in the above parameters between baseline and 6 weeks by Wilcoxon paired t test . The study was completed with 47 patients ( isotonics n = 23 ; isometrics n = 24 ) . VAS , DHI , NHPT , and RAQoL scores significantly improved in both groups by the end of 6th week compared to the baseline scores of the study ( for isotonics p = 0.036 , p = 0.002 ; p = 0.0001 , p = 0.003 ; for isometrics p = 0.021 , p = 0.002 , p = 0.005 , p = 0.01 , respectively ) . DAS 28 scores decreased in both exercise groups ( p = 0.002 ; p = 0.0001 , respectively ) , while isometrics showed a significant increase in dominant HS ( p = 0.029 ) , and isotonics showed a significant increase in non-dominant HS ( p = 0.013 ) . This study showed that isometric and isotonic h and exercises decrease pain and disease activity and improve h and functions , dexterity and quality of life as well as mildly increasing muscle strength in patients diagnosed as RA OBJECTIVE To study the short-term effects of physical therapy ( ice massage or wax packs , thermal baths , and faradic h and baths ) and exercise therapy on the rheumatoid h and . METHODS The effect of individual physical therapy and exercise therapy programs was evaluated in 50 r and omly selected rheumatoid arthritis in patients ( 38 women and 12 men ) . Mean patient age ( + /- SD ) was 47.94 + /- 11.22 years , and mean disease duration was 5.04 + /- 4.80 years . The control group consisted of 50 r and omly selected rheumatoid arthritis out patients ( 37 women and 13 men ; mean age 48.46 + /- 10.65 years , mean duration of disease 5.23 + /- 4.89 years ) who at the time of the investigation were not receiving any physical or exercise therapy . The clinical indices used for evaluation of inflammation included erythrocyte sedimentation rate ( ESR ) , pain intensity , proximal interphalangeal ( PIP ) joint size , and Ritchie articular index . H and grip strength , palmar tip-to-tip and key pinch finger strength , finger range of motion , and activities of daily living ( ADL ) were the parameters used to assess the functional h and status . The study was single-blinded and of 3 weeks duration . RESULTS In the physical therapy treated group , there was an improvement for most of the observed indices from baseline parameters that achieved statistical significance ( P < 0.01 and P < 0.005 ) after the 3-week study period . ESR and PIP joint size improved clinical ly but failed to reach statistical significance . Patients had a more significant improvement in h and pain , joint tenderness , and ADL score ( P < 0.005 ) than in
Output:
| Grip strength in various grip types ( power grip , key pinch , precision pinch and tripod pinch ) was found to improve by h and exercise therapy without having adverse effects on pain or disease activity .
Adaptations in the range of motion in response to h and exercise therapy were less pronounced .
There appears to be some transfer from the improvements on the body functioning level to the level of daily functioning , with the largest improvements found on grip ability .
With regard to the intervention content , there was some evidence in favour of a longer therapy duration and a higher therapy intensity .
No conclusions could be drawn on the effectiveness of the different types of exercises . |
MS213990 | ***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: on admission to hospital and a further 22 % subsequently developed them at some time during their stay . The average length of time the patients suffered from sores was three-fifths of their total length of stay and ranged from one day to more than six months . Contrary to popular opinion , they were not always a terminal event ( 31 % of these patients were eventually discharged ) , but even in those patients who died the average duration of the sores before death was 3.1 weeks . In a small work study conducted in the geriatric wards ( to be published ) the average nursing-time per patient was shown to be increased by 50 % in patients with pressure sores compared with that of equally ill patients without sores . A large amount of this STUDY OBJECTIVES We hypothesized that continuous , automatic turning utilizing a patient-friendly , low air loss surface would reduce the incidence of early ICU pneumonia in selected groups of critically ill medical patients . DESIGN Prospect i ve , r and omized , controlled clinical trial . SETTING Medical ICU of a large community teaching hospital . PATIENTS One hundred twenty-four critically ill new admissions to the medical ICU at Charity Hospital in New Orleans . INTERVENTIONS Patients were prospect ively r and omized within one of five diagnosis-related groups (DRG)--sepsis ( SEPSIS ) , obstructive airways disease ( OAD ) , metabolic coma , drug overdose , and stroke -- to either routine turning on a st and ard ICU bed or to continuous turning on an oscillating air-flotation bed for a total of five days . MEASUREMENTS AND RESULTS Patients were monitored daily during the treatment period for the development of pneumonia . The incidence of pneumonia during the first five ICU days was 22 percent in patients r and omized to the st and ard ICU bed vs 9 percent for the oscillating bed ( p = 0.05 ) . This treatment effect was greatest in the SEPSIS DRG ( 23 percent vs 3 percent , p = 0.04 ) . Continuous automatic oscillation did not significantly change the number of days of required mechanical ventilation , ICU stay , hospital stay , or hospital mortality overall or within any of the DRGs . CONCLUSIONS We conclude that air-supported automated turning during the first five ICU days reduces the incidence of early ICU pneumonia in selected DRGs ; however , this form of automated turning does not reduce other measured clinical outcome parameters A comparison of pressure reducing properties of alternating air , static air , and water mattress overlays was conducted with 57 patients in a surgical intensive care unit . Sacral and heel pressures in both recumbent and semi-Fowler 's positions were tested for each surface using a repeated measures design . Mean pressures for the alternating air mattress were significantly higher than pressures with other surfaces , regardless of position or site . There were significant main effects for position and site , with higher pressures in the semi-Fowler 's position and at the sacral site . A significant interaction between surface , site , and position was found . Pressure sores developed in eight patients , but the incidence was not significantly different across groups . A pressure measuring device constructed from available clinical material s proved to be both sensitive and reliable . The findings suggest alternating air overlays should be avoided , and that positioning and periodic position change to reduce sacral pressures for patients requiring prolonged upper body elevation is important OBJECTIVE To estimate the effectiveness of a new high-performance Australian medical sheepskin ( meeting Australian St and ard 4480.1 - 1998 ) in preventing pressure ulcers in a general hospital population at low to moderate risk of these ulcers . DESIGN Open-label r and omised controlled clinical trial . SETTING A large metropolitan teaching hospital in Melbourne , Victoria , in 2000 . PARTICIPANTS 441 patients aged over 18 years admitted between 12 June and 30 November 2000 , with expected length of stay over 2 days and assessed as at low to moderate risk of developing pressure ulcers . INTERVENTION Patients were r and omly allocated to receive a sheepskin mattress overlay for the duration of their hospital stay ( 218 patients ) or usual treatment , as determined by ward staff ( referent group , 223 patients ) . MAIN OUTCOME MEASURES Incidence rate and cumulative incidence of pressure ulcers , assessed daily throughout hospital stay . RESULTS 58 patients developed pressure ulcers ( sheepskin group , 21 ; referent group , 37 ) . Cumulative incidence risk was 9.6 % in the sheepskin group ( 95 % CI , 6.1%-14.3 % ) versus 16.6 % in the referent group ( 95 % CI , 12.0%-22.1 % ) . Patients in the sheepskin group developed new pressure ulcers at a rate less than half that of referent patients ( rate ratio , 0.42 ; 95 % CI , 0.26 - 0.67 ) . CONCLUSIONS The Australian Medical Sheepskin is effective in reducing the incidence of pressure ulcers in general hospital in patients at low to moderate risk of these ulcers There is limited research related to pressure ulcers in the ICU patient population and even less has focused on patients who have undergone cardiovascular surgery and IABP support . The objective of this article was to determine the incidence of pressure ulcers in the postoperative CVS patient with IABP support and to determine if LAL therapy was more effective in the prevention of pressure ulcers in this patient population . In a quasiexperimental design , a convenience sample of 36 adults was used . Patients who were placed on IABP support the day of surgery were enrolled into the study within 24 hours of admission to the cardiovascular recovery room . Data collection was daily for 4 days and continued if the patient developed a pressure ulcer . Final measurements were obtained on the day of hospital discharge . Instruments used were demographic data form , APACHE II , Patient Identification for Rotation Therapy , and the Braden Scale . The most common surgical patient in this pilot underwent aortocoronary bypass with IABP support . Pressure ulcers developed in 9 of 36 ( 25 % ) patients for a total of 17 ulcers . Patients who developed pressure ulcers were generally older , had a history of cerebrovascular disease , renal insufficiency , a higher APACHE II score , and Braden score of 9 on POD 1 . In addition , these patients generally had a lower hemoglobin level , higher serum creatinine level , and an altered level of consciousness on POD 1 . The results suggest that LAL therapy does make a difference in the prevention of pressure ulcers in the aortocoronary bypass patient with IABP support Intensive care wards have a high incidence of pressure sores . This trial , in an eight-bed unit , aim ed to compare the cost-effectiveness of constant-low-pressure and alternating-pressure support systems for preventing pressure sores . Patients without sores with a Norton risk score of < 13 were allocated to either alternating- or constant-low-pressure supports according to their hospital number . The cheapest supports were used initially , and changed for more sophisticated types if the patient 's pressure areas deteriorated . None of the 23 patients using low-cost alternating-pressure supports developed open sores and only one had to be transferred to a more sophisticated mattress because of persistent erythema . Eleven out of 20 patients on constant-low-pressure mattresses or overlays developed either persistent erythema ( three ) or sores ( eight ) . Ten were transferred to more expensive support systems . The mean cost of supports per patient in the alternating-pressure group was 44.50 pounds and in the constant-low-pressure group 86.20 pounds Pressure sores are a problem , especially in elderly patients . Our study was design ed to determine the effectiveness in pressure-sore prevention of a new interface-pressure decreasing mattress . In a prospect i ve r and omised controlled clinical trial we tested the Comfortex DeCube mattress ( Comfortex , Winona , USA ) against our st and ard hospital mattress in 44 patients with femoral-neck fracture and concomitant high pressure-sore risk score . In addition both groups were treated according to the Dutch consensus protocol for the prevention of pressure sores . On admission and 1 and 2 weeks after admission , pressure sores were grade d. The two groups were similar in patient characteristics and pressure-sore risk factors . At 1 week , 25 % of the patients nursed on the DeCube mattress and 64 % of the patients nursed on the st and ard mattress had clinical ly relevant pressure sores ( grade 2 or more ) . At 2 weeks the figures were 24 % and 68 % , respectively . The maximum score over the several body regions of the pressure-sore grading , measured on a 5-point sale , was significantly different in favour of the DeCube mattress at 1 week ( p = 0.0043 ) and 2 weeks ( p = 0.0067 ) postoperatively . We show that the occurrence of pressure sores and their severity can be significantly reduced when patients at risk are nursed on an interface-pressure decreasing mattress This study had three aims : to investigate if visco-elastic foam mattresses are more effective than st and ard hospital mattresses in reducing the incidence of pressure ulcers in patients with hip fractures ; to compare pressure ulcer grade and location and documented nursing prevention and treatment interventions in patients using the two types of mattresses ; to identify possible predictors of pressure ulcer development . Using a prospect i ve r and omised controlled trial design 101 patients ( mean age : 84 years ) were r and omly allocated either a visco-elastic foam mattress or a st and ard mattress . There was no significant difference in the incidence of pressure ulcers between the two groups , but patients on st and ard mattresses tended to develop more severe pressure ulcers . Furthermore , according to the documentation , patients with grade I pressure ulcers who were allocated a st and ard mattress received more preventive interventions , which may have reduced the differences in outcomes between the two groups . The research ers concluded that the results support the use of the test mattress . Significant predictors of pressure ulcer development were long waiting times for surgery and low haemoglobin levels at hospital admission The Pegasus Airwave mattress has been used for many years in the Eastbourne NHS Trust and has proven its efficiency in the prevention of pressure sores . Pegasus has now produced a new , improved , model : the Cairwave Therapy System . This article looks at criteria that may be used to determine whether the new model is suitable for patient care . The evaluation took the form of a r and omized controlled study in which 12 mattresses were r and omly allocated to patients --six Airwave mattresses and six Cairwave Therapy Systems -- over a 4-month period . The results of the evaluation showed that patients found the mattress comfortable . An encompassing cover reduced the risk of cross-infection , rehabilitation was supported by the firm edges of the bed and patient movement was easier due to the soft cover . During the trial all patients remained free from pressure sores & NA ; In a r and omized clinical trial , 187 adult patients with chronic neurologic conditions who were at a high risk of developing pressure sores were assigned for 3 months to either an alternating air ( AA ) mattress overlay or a silicore ( S ) mattress overlay . Costs associated with each overlay were calculated and compared by adding depreciation and yearly expenses related to maintenance , operation , and repair for 148 patients who completed the trial . Acceptability was measured by question naires and interviews involving 45 of the patients ’ primary nurses and a sample of 40 patients ( 20 from each overlay group ) . The annual cost of the AA overlay was 54 % more than that of the S overlay . Although most nurses ( more than 74 % ) believed that both overlays helped prevent pressure sores and deter their progression , many ( more than 56 % ) would not recommend either type to other facilities or to patients at home due to specific negative features . Implication s for manufacturers , investigators , clinicians , and administrators are identified Specialised beds which are design ed to prevent unacceptably high levels of pressure loads on skin surfaces are frequently used in the management of patients with , or at risk of developing , pressure sores . This study compares the intersurface pressure on ' at risk ' body sites of six subjects on a new design of water bed with those obtained from resting on a King 's Fund bed . The findings show flotation on the water bed offers more effective support to body tissue than that provided by the King 's Fund bed This experimental study was design ed to identify the etiology of pressure ulcers in a surgical sample and to evaluate a special OR mattress overlay in preventing pressure ulcer development . Surgical patients ( N = 413 ) were r and omized to receive " usual perioperative care " or the new mattress overlay . Over six postoperative days , 89 patients ( 21.5 % ) developed pressure ulcers , primarily stage I. Only 2 % developed stage II or IV ulcers . Patients with ulcers were statistically older , had diabetes , were smaller in body mass , had lower Braden Scale scores on admission , and used the new mattress overlay ( P < .02 ) . Pressure ulcers that presented as " burns " or ecchymosis did not deteriorate to stage III or IV ulcers during the study . The mattress overlay was not effective in preventing pressure ulcer development Abstract Objective To assess the cost effectiveness of alternating pressure mattresses compared with alternating pressure overlays for the prevention of pressure ulcers in patients admitted to hospital . Design Cost effectiveness analysis carried out alongside the pressure relieving support surfaces ( PRESSURE ) trial ; a multicentre UK based pragmatic r and omised controlled trial . Setting 11 hospitals in six UK NHS trusts . Participants Intention to treat population comprising 1971 participants . Main outcome measures Kaplan Meier estimates of restricted mean time to development of pressure ulcers and total costs for treatment in hospital . Results Alternating pressure mattresses were associated with lower overall costs ( £ 283.6 per patient on average , 95 % confidence interval - £ 377.59 to £ 976.79 ) mainly due to reduced length of stay in hospital , and greater benefits ( a delay in time to
Output:
| There is one high quality trial comparing the different alternating pressure devices for pressure ulcer prevention which suggests that alternating pressure mattresses may be more cost effective than alternating pressure overlays .
A study of Accident & Emergency trolley overlays did not identify a reduction in pressure ulcer incidence .
There are tentative indications that foot waffle heel elevators , a particular low air loss hydrotherapy mattress and two types of operating theatre overlays are harmful .
The relative merits of higher-tech constant low pressure and alternating pressure for prevention are unclear but alternating pressure mattresses may be more cost effective than alternating pressure overlays .
Medical grade sheepskins are associated with a decrease in pressure ulcer development . |
MS213991 | ***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 We prospect ively analyzed and compared the functional and clinical results of patients with st and ard open and minimally invasive repair with the Achillon suture system at mid-term followup . MATERIAL S AND METHODS From February 2004 to May 2007 , 40 consecutive patients were operated for the treatment of acute Achilles tendon rupture with two different methods . None of the cases required adjunctive procedures like plantaris , flexor hallucis longus or gastrocnemius augmentation ( Lindholm , Bosworth ) to allow for acceptable end to end apposition . The patients were divided equally into two groups . In Group 1 , only Krakow end-to-end suturing technique and in Group 2 , Minimal invasive repair with Achillon suture system ( Integra Life Sciences Corporation , Plainsboro , NJ ) was used respectively . The average age of the patients was 40 years . Patients in study groups were followed up at mean of 22.4 ( range , 10 to 48 ) months after surgery . At the end of the followup time , functional outcome scores and complications were evaluated . RESULTS The AOFAS hindfoot clinical outcome scores were 98.7 in Group 1 , 96.8 in Group 2 . Although there was a numerical increase in AOFAS Scores in Group 1 , there was no significant difference . The surgical outcome concerning local tenderness , skin adhesions , scar and tendon thickness was better in Group 2 than in Group 1 with statistical significance . CONCLUSION Although functional outcomes of both treatment groups were the same , minimally invasive repair with the Achillon suture system provided safe , reliable and practical treatment with low risk of complications in the treatment of acute Achilles tendon ruptures In a prospect i ve , r and omised , multicentre study , 112 patients ( 99 men and 13 women , aged between 21 and 63 years ) with acute , complete rupture of tendo Achillis were allocated either to surgical treatment followed by early functional rehabilitation , using a brace , or to non-surgical treatment , with plaster splintage for eight weeks . The period of follow-up was for two years . Evaluation was undertaken by independent observers and comprised interviews , clinical measurements , isokinetic muscle performance tests , heel-raise tests and an overall outcome score . The rate of rerupture was 20.8 % after non-surgical and 1.7 % after surgical treatment ( p < 0.001 ) . Surgical and non-surgical treatment produced equally good functional results if complications were avoided . However , the rate of rerupture after non-surgical treatment was unacceptably high BACKGROUND The optimal rehabilitation protocol after surgical repair of an Achilles tendon rupture has not been well defined . The objective of this r and omized study was to compare the effect of early weight-bearing with that of non-weight-bearing on early postoperative recovery following repair of an acutely ruptured Achilles tendon . METHODS Between October 2003 and May 2006 , 110 patients with a surgically repaired Achilles tendon rupture were enrolled from one of two major trauma-care tertiary hospitals . All patients were non-weight-bearing for the first two weeks postoperatively . At the two-week postoperative visit , patients were r and omized to either weight-bearing or non-weight-bearing for an additional four weeks . Compliance was measured with a pressure sensor in the fixed-hinge ankle-foot orthosis given to each patient . Follow-up assessment s were performed at six weeks , three months , and six months postoperatively . The primary outcome was health-related quality of life assessed with use of the R AND 36-Item Health Survey ( R AND -36 ) . Secondary outcomes were activity level , calf strength , ankle range of motion , return to sports and work , and complications . RESULTS Ninety-eight patients ( 89 % ) completed the six-month follow-up . At six weeks , the weight-bearing group had significantly better scores than the non-weight-bearing group in the R AND -36 domains of physical functioning , social functioning , role-emotional , and vitality scores ( p < 0.05 ) . Patients in the weight-bearing group also reported fewer limitations of daily activities at six weeks postoperatively ( p < 0.001 ) . At six months , no significant differences between the groups were seen in any outcome , although both groups had poor endurance of the calf musculature . No rerupture occurred in either group . CONCLUSIONS Early weight-bearing after surgical repair of an acute Achilles tendon rupture improves health-related quality of life in the early postoperative period and has no detrimental effect on recovery We performed two independent , r and omised , controlled trials in order to assess the potential benefits of immediate weight-bearing mobilisation after rupture of the tendo Achillis . The first trial , on operatively-treated patients showed an improved functional outcome for patients mobilised fully weight-bearing after surgical repair . Two cases of re-rupture in the treatment group suggested that careful patient selection is required as patients need to follow a structured rehabilitation regimen . The second trial , on conservatively-treated patients , provided no evidence of a functional benefit from immediate weight-bearing mobilisation . However , the practical advantages of immediate weight-bearing did not predispose the patients to a higher complication rate . In particular , there was no evidence of tendon lengthening or a higher re-rupture rate . We would advocate immediate weight-bearing mobilisation for the rehabilitation of all patients with rupture of the tendo Achillis A prospect i ve r and omized controlled trial comparing open and percutaneous repair of closed ruptured Achilles tendons was performed over a period of 30 months . Sixty-six patients from seven district general hospitals were entered into the study with 33 patients r and omized into each group . A modification of the technique described by Ma and Griffith was used in the percutaneous group and a Kessler suture supplemented with interrupted sutures was used in the open group . Patients were followed up for a minimum of six months . The mean age was 38.5 years ( 26 to 53 years ) . Forty patients were male and 26 female . After the rupturing event but prior to surgery , it was noted that seven patients had paresthesia in the territory of the sural nerve . The mean duration of immobilization was 12.4 weeks ( 10 to 14 ) . The complications in the open group included seven wound infections ( 21 % ) , two adhesions ( 6 % ) and two cases of re-rupture ( 6 % ) . In the percutaneous group there were three cases of wound puckering ( 9 % ) , one re-rupture ( 3 % ) and one case with persistent paresthesia in the sural nerve territory ( 3 % ) . The difference in infective wound complications between the two groups was statistically significant ( Fisher 's exact test P = 0.01 ) . Percutaneous repair is advocated on the basis of the low rate of complications and improved cosmetic appearance BACKGROUND Different regimens of early motion of the ankle after operative treatment of a ruptured Achilles tendon have been suggested since the late 1980s . However , as far as we know , no controlled studies comparing these regimens with conventional immobilization in a cast have been reported . METHODS In a prospect i ve study , seventy-one patients who had an acute rupture of the Achilles tendon were r and omized to either conventional postoperative management with a cast for eight weeks or early restricted motion of the ankle in a below-the-knee brace for six weeks . The brace was modified with an elastic b and on the posterior surface , in a manner similar to the principle of Kleinert traction . Metal markers were placed in the tendon , and the separation between them was measured on serial radiographs during the first twelve weeks postoperatively . The patients were assessed clinical ly when the cast or brace was removed , at twelve weeks postoperatively , and at a median of sixteen months postoperatively . RESULTS The separation between the markers at twelve weeks postoperatively was nearly identical in the two groups , with a median separation of 11.5 millimeters ( range , zero to thirty-three millimeters ) in the patients managed with early motion of the ankle and nine millimeters ( range , one to forty-one millimeters ) in the patients managed with a cast . The separation was primarily correlated with the initial tautness of the repair ( r[S ] = 0.45 ) . No patient had excessive lengthening of the tendon . The patients managed with early motion had a smaller initial loss in the range of motion , and they returned to work and sports activities sooner than those managed with a cast . Furthermore , there were fewer visible adhesions between the repaired tendon and the skin in the patients managed with early motion , and these patients were subjectively more satisfied with the overall result . The patients in both groups recovered a median of 89 percent of strength of plantar flexion compared with that of the noninjured limb , as measured with an isometric strain-gauge at 15 degrees of dorsiflexion . The heel-rise index was similar for both groups : 0.88 for the patients managed with early motion and 0.89 for those managed with a cast . CONCLUSIONS Early restricted motion appears to shorten the time needed for rehabilitation . There were no complications related to early motion in these patients . However , early unloaded exercises did not prevent muscle atrophy Introduction There is a trend towards surgical treatment of acute ruptured Achilles tendon . While classical open surgical procedures have been shown to restore good functional capacity , they are potentially associated with significant complications like wound infection and paresthesia . Modern mini-invasive surgical techniques significantly reduce these complications and are also associated with good functional results so that they can be considered as the surgical treatment of choice . Nevertheless , there is still a need for conservative alternative and recent studies report good results with conservative treatment in rigid casts or braces . Patients / method We report the use of a dynamic ankle brace in the conservative treatment of Achilles tendon rupture in a prospect i ve non-r and omised study of 57 consecutive patients . Patients were evaluated at an average follow-up time of 5 years using the modified Leppilahti Ankle Score , and the first 30 patients additionally underwent a clinical examination and muscular testing with a Cybex isokinetic dynamometer at 6 and 12 months . Results We found good and excellent results in most cases . We observed five complete re-ruptures , almost exclusively in case of poor patient ’s compliance , two partial re-ruptures and one deep venous thrombosis complicated by pulmonary embolism . Conclusion Although prospect i ve comparison with other modern treatment options is still required , the functional outcome after early ankle mobilisation in a dynamic cast is good enough to ethically propose this method as an alternative to surgical treatment We prospect ively analyzed the functional and clinical results of patients who underwent a single end-to-end suture and an augmented tendon repair with plantaris tendon at middle-term follow-up . From January 2003 to May 2005 , 30 consecutive patients were operated on for the treatment of acute Achilles ' tendon rupture by means of 2 different methods . No cases required adjunctive procedures to allow for acceptable end-to-end apposition . All ruptures were acute and repairable . The patients were divided into 2 groups . In group 1 , augmentation with plantaris tendon was performed in addition to the Krakow end-to-end suturing technique in 16 patients , and in group 2 , only the Krakow end-to-end suturing technique was used in 14 patients . The average age of the patients was 40.6 years . Patients in the study groups were followed up at a mean of 17.8 months after surgery . At the end of the follow-up , functional and subjective outcome scores were evaluated . The American Orthopaedic Foot and Ankle Society hindfoot clinical outcome scores were 96.7 in group 1 and 98.8 in group 2 . Although there was a numerical increase in group 2 , no significant difference was determined between the 2 study groups statistically . The surgical outcome concerning local tenderness , skin adhesion scar , and tendon thickness was better in group 2 than in group 1 without a statistical significance . Although functional outcomes of both treatment groups were the same , the end-to-end suturing technique provided a safer and more reliable treatment with a low risk of complications in the treatment of acute Achilles ' tendon ruptures compared with the plantaris tendon augmentation technique Purpose To study the effects of early weightbearing and ankle mobilization after acute repair of ruptured Achilles tendon . Study Design Comparative longitudinal study . Methods Patients in group 1 were postoperatively immobilized with their ankle in gravity equinus , they were encouraged to bear weight on the operated limb as soon as possible to full weightbearing , and they received a single cast change at 2 weeks , with the ankle accommo date d in an anterior splint in a planti grade position , allowing the ankle to be plantar flexed fully but not dorsiflexed above neutral . Patients in group 2 were immobilized with their ankle in full equinus with a cast change at 2 weeks , when the ankle was immobilized in mid equinus , and at 4 weeks , when the ankle was immobilized in a planti grade position , and they were advised to bear weight . Results Patients in group 1 attended fewer outpatient visits , completely discarded their crutches at an average of 2.5 weeks , and more were satisfied with the results of surgery . At ultrasonography , the average thickness of the repaired tendon was 12.1 mm , with no difference in the thickness of the ruptured tendon regardless of postoperative management . There was no significant difference in isometric strength between the two groups . Conclusions Early weightbearing with the ankle planti grade is not detrimental to the outcome of repair after acute rupture of the Achilles tendon and shortens the time needed for rehabilitation . However , strength deficit and muscle atrophy are not prevented A combined open and percutaneous operative technique has been devised for repair of tendo Achillis . This minimises postoperative scarring . We compared
Output:
| The two moderate-strength recommendations include the suggestions for early postoperative protective weight bearing and for the use of protective devices that allow for postoperative mobilization |
MS213992 | ***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 this prospect i ve r and omized double-blind study , we compared the incidence of emesis and 48-h recovery profiles after a single dose of ketorolac vs fentanyl in dexamethasone-pretreated children undergoing ambulatory adenoidectomy and laser-assisted tonsillectomy ( ADLAT ) . We evaluated the hypothesis that avoiding the use of opioids and replacing them with an equianalgesic dose of ketorolac , a nonsteroidal anti-inflammatory drug , would reduce the incidence of postoperative nausea and vomiting ( PONV ) . METHODS Fifty-seven ASA I and II children aged 1.710 years who underwent ADLAT were r and omized to receive either intravenous ketorolac ( 1 mg.kg(-1 ) ) or fentanyl ( 2 microg.kg(-1 ) ) for pain control during a st and ardized general anaesthetic with propofol infusion . The early ( postanaesthesia care unit , day surgical area ) and late postoperative courses were compared between the groups . RESULTS The incidence of PONV was low and equal in both groups . Postoperative pain scores were equal at all stages of followup . Agitation scores in the postanaesthesia care unit were significantly higher in the ketorolac group , but this had no effect on the late variables of behaviour studied . CONCLUSIONS Ketorolac showed no advantage over fentanyl in reducing the incidence of PONV in children undergoing ADLAT Investigators from Bristol described a fentanyl‐ and diclofenac‐based analgesic technique for tonsillectomy with low postoperative nausea and vomiting rates and low pain scores . This study compared the effectiveness of a modified Bristol technique with a codeine‐based regimen with respect to PONV and analgesia . Sixty‐five children , ASA 1‐2 , were r and omly assigned to either the Bristol group ( fentanyl 1–2 μg.kg−1 and diclofenac 1–2 mg.kg−1 ) or codeine group ( codeine 1.5 mg.kg−1 ) . All children received paracetamol 15 mg.kg−1 and dexamethasone 0.1 mg.kg−1 . Postoperative nausea and vomiting and pain scores were recorded hourly , and fitness for discharge was assessed at 4 h. The overall incidence of postoperative nausea and vomiting was 21 % with no difference between groups ( Bristol group 8/30 , codeine group 5/32 , p = 0.29 ) . Children in the Bristol group required analgesia earlier than those in the codeine group ( p < 0.005 ) , but maximum pain scores were not different ( Bristol group median ( IQR [ range ) 4.5 ( 3‐5 [ 0‐5 ] ) , codeine group 4.0 ( 2‐5 [ 1‐5 ] ) , p = 0.15 ) . Twenty‐three per cent of children were assessed as not fit for discharge at 4 h. The codeine‐based regimen may have a small advantage over the Bristol regimen , but neither technique seems ideally suited for a day‐case service without a longer period of observation & NA ; The efficacy of ketorolac , a non‐steroidal anti‐inflammatory drug , in the management of moderate to severe pain in adults , has led us to conduct a trial of this analgesic in children following tonsillectomy . Children were r and omized to receive intramuscular ( i.m . ) ketorolac ( 1 mg/kg , EXP group , n = 45 ) or saline ( CTL group , n = 42 ) at the completion of surgery . Intravenous ( i.v . ) fentanyl ( 0.5 & mgr;g/kg/dose ) was administered in repeated doses postoperatively . Pain intensity was measured using both the Oucher and the Children 's Hospital of Eastern Ontario Pain Scale ( CHEOPS ) to allow for comparison between self‐report and behavioral measures of pain intensity . Severity of postoperative bleeding was measured using a 4‐point rating scale . The EXP group had a significant reduction in total fentanyl dose ( mean : 35.9 & mgr;g ) compared to the CTL group ( mean : 48.3 & mgr;g , t = −2.21 , P < 0.03 ) . There was a statistically significant decrease in pre‐fentanyl CHEOPS scores in the Post‐Anesthesia Care Unit ( PACU ) in the ketorolac group ( F ( 2,30 ) = 5.34 , P < 0.01 ) , but not in the saline group ( F ( 2.24 ) = 2.46 , P > 0.05 ) . In the first hour postoperatively , the CHEOPS demonstrated significant decreases in pain intensity scores in response to opioids , in both groups . In the PACU , children were unable to provide a self‐report of pain intensity potentially due to a variety of factors ( e.g. , emergence delirium , agitation , excitement , sedation , and /or pain ) . However , during the remainder of the postoperative stay , the photographic scale of the Oucher was a more valid measure of pain intensity than the CHEOPS . There were no differences between the 2 groups in the severity of postoperative bleeding . Children in the EXP group were discharged significantly earlier ( i.e. , 30 min , t = −2.22 , P < 0.03 ) . Our data demonstrate that i.m . administration of ketorolac , at the end of surgery , significantly reduces opioid requirements and shortens length of stay without any evidence of increased bleeding . In addition , our data suggest that the patient 's altered level of consciousness and attention span may diminish the utility of self‐report measures of pain intensity in the immediate postoperative period Purpose To compare the incidence of vomiting following codeine or ketorolac for tonsillectomy in children . Methods We had planned to enrol 240 patients , aged 2–12 yr undergoing elective tonsillectomy into a r and omized , single-blind study in University Children ’s Hospital . The study was terminated , after 64 patients because interim analysis of the data by a blinded non- study scientist concluded that the patients were at undue risk of excessive perioperative bleeding . After induction of anaesthesia by inhalation with N2O/halothane or with propofol 2.5−3.5 mg · kg−1 iv , the children were administered 150 μg · kg−1 ondansetron and 50 μg · kg−1 midazolam . Maintenance of anaesthesia was with N2O and halothane in O2 . Subjects were administered either 1.5 mg · kg−1 codeine i m or 1 mg · kg−1 ketorolac iv before the commencement of surgery . Intraoperative blood loss was measured with a Baxter Medi-Vac ® Universal Critical Measurement Unit . Postoperative management of vomiting and pain was st and ardized . Vomiting was recorded for 24 hr after anaesthesia . Data were compared with ANOVA , Chi-Square analysis and Fisher Exact Test . Results Thirty-five subjects received ketorolac . Demographic data were similar . The incidence of vomiting during the postoperative period was 31 % in the codeine-group and 40 % in the ketorolac-group . Intraoperative blood losses was 1.3 ± 0.8 ml · kg−1 after codeine and 2.2 ± 1.9 ml · kg−1 after ketorolac ( mean ± SD ) P < 0.05 . Five ketorolac-treated patients had bleeding which led to unscheduled admission to hospital , P < 0.05 , Exact Test . Conclusion Preoperative ketorolac increases perioperative bleeding among children undergoing tonsillectomy without beneficial effects . RésuméObjectifComparer l’incidence des vomissements après l’analgésie au kétorolac et à la codéine chez les amygdalectomisés . MéthodesLes auteurs prévoyaient inclure 240 patients âgés de 2 à 12 ans programmés pour une amygdalectomie réglée dans cette étude aléatoire en simple aveugle . L’étude a été terminée après 64 patients après qu’une analyse intérimaire des données par un scientifique sans implication dans l’étude eût montré que les patients étaient soumis à un risque excessif de saignement postopératoire . Après l’induction de l’anesthésie à l’halothane/N2O et au propofol 2,5 - 3,5 mg · kg−1 iv , les enfants ont reçu 150 μg · kg−1 d’ondensetron et 50 μg · kg−1 de midazolam . L’anesthésie a été entretenue avec du N2O et de l’halothane en O2 . Les sujets ont ensuite reçu soit de la codéine 1,5 mg·kg−1 i m soit du kétorolac 1 mg · kg−1 iv avant la chirurgie . La perte sanguine peropératoire a été déterminée avec une dispositif de mesure Baxter Medi-Vac ® . Le traitement postopératoire des vomissements et de la douleur a été uniforme . Les vomissements ont été enregistrés pendant 24 heures après l’anesthésie . Les données ont été comparées par ANOVA , l’analyse du Chi2 et le test d’exactitude de Fisher . RésultatsTrente-cinq enfants ont reçu du kétorolac . Les données démographiques étaient identiques . L’incidence des vomissements en postopératoire a été de 31 % dans le groupe codéine et de 40 % dans le groupe kétorolac . Les pertes sanguines peropératoires ont été de 1,3 ± 0,8 ml · kg−1 après la codéine et de 2,2 ± 1,9 ml · kg−1 après le kétorolac ( moyenne ± ET ) , P < 0,05 . Cinq patients traités au kétorolac ont eu des saignements qui ont nécessité une réadmission à l’hôpital , P < 0,05 . Conclusion Le kétorolac administré en préopératoire augmente sans effets bénéfiques les saignements périopératoires chez les enfants amygdalectomisés The efficacy of benzydamine hydrochloride ( Difflam ) spray to relieve pain from postoperative tonsillectomy was assessed , but it was found that it did not relieve the symptoms after operation when compared to matching placebo 127 children scheduled for elective tonsillectomy or adenotonsillectomy were studied . Anaesthesia was induced with propofol and maintained with a volatile agent . At induction the child received either rectal diclofenac 1 mg.kg-1 with or without fentanyl 0.75 microgram.kg-1 i.v . , or intravenous tenoxicam 0.4 mg.kg-1 with or without fentanyl 0.75 microgram.kg-1 i.v . Blood loss was measured peroperatively . Nausea and vomiting scores , sedation scores and pain scores were recorded in the recovery room , at one , two , four and eight h postoperatively and at discharge . There were no significant differences in blood loss between the groups or between nausea and vomiting scores . Pain scores in the tenoxicam without fentanyl group were significantly higher in recovery ( P < 0.05 ) than the diclofenac group without fentanyl and both fentanyl groups . This group required supplemental analgesia earlier although this was not significant . The pain scores in the diclofenac with fentanyl group were significantly lower at one h and four h than the group receiving diclofenac alone ( P = 0.008 and 0.02 respectively ) BACKGROUND We investigated the effect of preincisional rectal diclofenac on pain scores and postoperative morphine requirements of children undergoing tonsillectomy after remifentanil-propofol anaesthesia in a r and omized clinical trial . METHODS Induction and maintenance of anaesthesia were with remifentanil and propofol . Forty children were r and omly assigned into two groups before incision . The diclofenac group ( n=20 ) received diclofenac suppositories ( approximately 1 mg x kg(-1 ) ) and the control group ( n=20 ) received no treatment . Following discontinuation of remifentanil , patient-controlled analgesia ( PCA ) with morphine ( a loading dose 50 micro g x kg(-1 ) , a background infusion 4 micro g x kg(-1 ) x h(-1 ) and a dem and dose 20 micro g x kg(-1 ) with 5-min intervals ) was started . We assessed pain score [ verbal analogue scales ( VAS ) , 0 - 10 ] and sedation level at 5-min intervals and recorded the total morphine consumption of the first hour in the PACU . Patients were discharged to the ward with a new PCA morphine programme ( a dem and dose 20 micro g.kg-1 with a lockout time of 30 min , for 4 h ) , and total morphine consumption was recorded . RESULTS The mean VAS score of the diclofenac group was significantly lower than the control group on arrival in the PACU ( 2.85 + /- 0.77 , 7.60 + /- 0.83 , respectively , P < 0.01 ) and it remained significantly lower in the PACU stay of the children . The mean total morphine consumption of the diclofenac group was less than the control group in the PACU ( 130.33 + /- 11.26 and 169.92 + /- 9
Output:
| There is insufficient evidence to exclude an increased risk of bleeding when NSAIDs are used in paediatric tonsillectomy .
They do however confer the benefit of a reduction in vomiting |
MS213993 | ***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 determine the immediate effects of modified Proprioceptive Neuromuscular Facilitation ( PNF ) stretching ( group I ) versus Myofascial Trigger Point ( MTrP ) therapy plus modified PNF stretching ( group II ) in comparison to a control group receiving no treatment . DESIGN R and omized , assessor-blind , ( 3 x 4 ) mixed-model repeated measures . SETTING University laboratory . PARTICIPANTS Thirty physically active males with tight hamstrings and at least one latent MTrP on muscles innervated by the lumbosacral , sciatic , tibial and common peroneal nerves . MAIN OUTCOME MEASURES Knee range of motion ( ROM ) , stretch perception , pressure pain threshold ( PPT ) and subjective pain intensity . Outcomes were evaluated at baseline , immediately after treatment , at 10 and 30 min . RESULTS Significant changes over time occurred for group II in all outcomes ( p < or = 0.001 ) . Group II also showed lower pain intensity scores than group I immediately post-treatment ( p = 0.045 ) and a strong clinical effect over group I in ROM at all follow-ups ( effect sizes = 0.9 - 1.0 , p < or = 0.05 ) . Other differences were found between both stretching groups as compared to the control group ( p < or = 0.05 ) . CONCLUSION The results indicate immediate pre- to post-treatment benefits from MTrP therapy combined with modified PNF stretching in young and physically active males with latent MTrPs OBJECTIVE To evaluate the effects of an 8-week water physical therapy program on cervical and shoulder pain , pressure sensitivity , and the presence of trigger points ( TrPs ) in breast cancer survivors . DESIGN R and omized , controlled trial . SETTING To date , no study has investigated effects of water therapy in breast cancer . PATIENTS Sixty-six breast cancer survivors were r and omly assigned into two groups : WATER group , who received a water exercise program or CONTROL group who received the usual care treatment for breast cancer . INTERVENTIONS The WATER therapy program consisted of 24 sessions ( 3 times/week over 8 weeks ) of low-intensity exercises in a warm pool ( 32 ° C ) . Each session included 10-minute warm-up period ; 35 minutes of aerobic , low-intensity endurance , and core stability training ; and a 15-minute cool-down period ( stretching and relaxation ) . OUTCOMES Neck and shoulder pain ( visual analog scale , 0 - 100 mm ) , pressure pain thresholds ( PPTs ) over C5-C6 zygapophyseal joints , deltoid muscles , second metacarpal , and tibialis anterior muscles , and the presence of TrPs in cervical-shoulder muscles were assessed at baseline and after the 8-week program by an assessor blinded to treatment allocation . RESULTS The WATER group demonstrated a between-group improvement for neck pain of -31 mm ( 95 % confidence interval [CI]-49 to -22 , P < 0.001 ; effect size 1.1 , 0.81 - 1.75 ) and for shoulder-axillary of -19 mm ( -40 to -04 , P = 0.046 ; effect size 0.70 , 0.14 - 1.40 ) . Improvements were also noted for PPT levels over C5-C6 joints ( between-group differences , affected side : 27.7 kPa , 95 % CI 3.9 - 50.4 ; unaffected : 18.1 kPa , 95 % CI 6.1 - 52.2 ) . No between-group differences for PPT over the remaining points were observed ( P > 0.05 ) . Finally , patients in the WATER program showed a greater reduction of active TrPs as compared with the CONTROL group ( P < 0.05 ) . CONCLUSIONS An 8-week water therapy program was effective for improving neck and shoulder/axillary pain , and reducing the presence of TrPs in breast cancer survivors as compared with usual care ; however , no significant changes in widespread pressure pain hyperalgesia were found Background : High insulin and insulin-like growth factor-I ( IGF-I ) levels may be associated with an increased breast cancer risk and /or death . Given the need to identify modifiable factors that decrease insulin , IGF-I , and breast cancer risk and death , we investigated the effects of a 6-month r and omized controlled aerobic exercise intervention versus usual care on fasting insulin , IGF-I , and its binding protein ( IGFBP-3 ) in postmenopausal breast cancer survivors . Methods : Seventy-five postmenopausal breast cancer survivors were identified from the Yale-New Haven Hospital Tumor Registry and r and omly assigned to an exercise ( n = 37 ) or usual care ( n = 38 ) group . The exercise group participated in 150 minutes per week of moderate-intensity aerobic exercise . The usual care group was instructed to maintain their current physical activity level . A fasting blood sample was collected on each study participant at baseline and 6 months . Blood levels of insulin and IGF were measured with ELISA . Results : On average , exercisers increased aerobic exercise by 129 minutes per week compared with 45 minutes per week among usual care participants ( P < 0.001 ) . Women r and omized to exercise experienced decreases in insulin , IGF-I , and IGFBP-3 , whereas women r and omized to usual care had increases in these hormones . Between-group differences in insulin , IGF-I , and IGFBP-3 were 20.7 % ( P = 0.089 ) , 8.9 % ( P = 0.026 ) , and 7.9 % ( P = 0.006 ) , respectively . Conclusions : Moderate-intensity aerobic exercise , such as brisk walking , decreases IGF-I and IGFBP-3 . The exercise-induced decreases in IGF may mediate the observed association between higher levels of physical activity and improved survival in women diagnosed with breast cancer . ( Cancer Epidemiol Biomarkers Prev 2009;18(1):306–13 The aim of this study was to evaluate the effects of scapular stabilization exercise ( SSE ) on pain intensity , pressure pain threshold ( PPT ) , muscle tension and anxiety in patients with scapulocostal syndrome ( SCS ) . Thirty-six patients were r and omly assigned to receive a 30-minute session of either SSE or control ( relaxed by lying supine quietly ) for 12 sessions over a period of 4 weeks . Pain intensity , PPT , muscle tension and anxiety were assessed before and after a 4-week intervention period and 2 weeks after the intervention period . The adverse effects were evaluated after completion of the intervention period . Results indicated that the SSE group showed a significant improvement in all parameters after the intervention period and at 2 weeks after the intervention period ( p < 0.05 ) . For all outcomes , similar changes were not found in the control group . The adjusted post-test mean values of each assessment time point for pain intensity , muscle tension and anxiety were significantly lower in the SSE group than those of the control group ( p < 0.05 ) . Moreover , the values for PPT were significantly higher in the SSE group ( p > 0.05 ) . There were no reports of adverse effects in either group . We therefore conclude that SSE can improve pain related parameters and could be an effective intervention for SCS 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 Summary Cold pressor pain and exercise causes multisegmental increases in pressure pain thresholds . Exercise is dominated by local manifestations of hypoalgesia , whereas cold pressor pain results generally in remote hypoalgesia . ABSTRACT Pain inhibitory mechanisms are often assessed by paradigms of exercise‐induced hypoalgesia ( EIH ) and conditioned pain modulation ( CPM ) . In this study it was hypothesized that the spatial and temporal manifestations of EIH and CPM were comparable . The participants were 80 healthy subjects ( 40 females ) , between 18 and 65 years of age in this r and omized , repeated‐ measures cross‐over trial that involved data collection on 2 different days . CPM was assessed by 2 different cold pressor tests ( h and and foot ) . EIH was assessed by 2 intensities of aerobic bicycling exercises and 2 intensities of isometric muscle contraction exercises ( arm and leg ) . Pressure pain thresholds ( PPTs ) were recorded before , during , after , and 15 minutes after conditioning/exercise at sites local to and remote from the extremity used for cold pressor stimulation and exercise . PPTs increased at local as well as at remote sites during both cold pressor tests and after all of the exercise conditions except low‐intensity bicycling . EIH after bicycling was higher in women than in men . CPM and the EIH responses after isometric exercises were comparable in men and women and were not affected by age . The EIH response was larger in the exercising body part compared with nonexercising body parts for all exercise conditions . High‐intensity exercise produced greater EIH responses than did low‐intensity exercise . The change in PPTs during cold pressor tests and the change in PPTs after exercises were not correlated . The CPM response was not dominated by local manifestations , and the effect was seen only during the stimulation , whereas exercise had larger local manifestations , and the effects were also found after exercise OBJECTIVE This prospect i ve study examined circulating cytokines in patients with fibromyalgia ( FM ) over 6 months rather than at only one timepoint , and investigated correlations between serum cytokine concentrations and pain intensity in FM patients receiving multidisciplinary pain therapy . METHODS Serum concentrations of proinflammatory cytokines interleukin 6 ( IL-6 ) , IL-8 , and tumor necrosis factor-alpha ( TNF-alpha ) and antiinflammatory cytokines IL-4 and IL-10 were measured ( Bio-Plex system ) in 20 FM patients and 80 healthy subjects on admission and 10 , 21 , and 180 days after initiation of treatment and correlated to pain intensity . RESULTS On admission , serum levels of IL-8 ( p < 0.001 ) and TNF-alpha ( p < 0.001 ) , but not IL-6 , were elevated in patients with FM . No significant difference in IL-4 and IL-10 was found between FM patients and controls . High IL-8 levels remained consistent during the followup , but TNF-alpha was already reduced after 10 days and until 6 months after therapy . After 6 months ' treatment with multidisciplinary pain therapy , IL-8 and TNF-alpha levels were significantly lower than at the beginning ( p < 0.05 for IL-8 , p < 0.001 for TNF-alpha ) . IL-8 but not TNF-alpha serum levels were correlated with pain intensity ( r = -0.782 , p = 0.001 ) in FM patients after 6 months ' multidisciplinary pain therapy . CONCLUSION Our results suggest that proinflammatory cytokines TNF-alpha and IL-8 are involved in FM , but they do not apparently provoke the pain of FM directly . Multidisciplinary pain therapy modified the cytokine profile in patients with FM during the observation period OBJECTIVES The purpose of this study was to investigate the effects of electrotherapy and exercise on pain intensity and mobility of connective tissue in patients with myofascial pain syndrome ( MPS ) in their cervical region . METHODS 60 patients were divided into 3 groups using a r and om allocation programme method . A hotpack was applied , and ultrasound was carried out on the patients
Output:
| Visual analogue scale pain intensity ratings and the number of myofascial trigger points present in the neck and shoulder/axillary area of participants significantly decreased in the exercise group compared to those in the control group .
Pain pressure thresholds significantly increased in muscle areas of the cervical spine in the water exercise group .
Aerobic exercise presents a potential treatment modality for managing myofascial pain . |
MS213994 | ***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: Aims R and omized trials showed non-inferior or superior results of the non-vitamin-K-antagonist oral anticoagulants ( NOACs ) compared with warfarin . The aim of this study was to assess the effectiveness and safety of dabigatran ( direct thrombin inhibitor ) vs. acenocoumarol ( vitamin K antagonist ) in patients with atrial fibrillation ( AF ) in daily clinical practice . Methods and results In this observational study , we evaluated all consecutive patients who started anticoagulation because of AF in our outpatient clinic from 2010 to 2013 . Data were collected from electronic patient charts . Primary outcomes were stroke or systemic embolism and major bleeding . Propensity score matching was applied to address the non-r and omized design . In total , 920 consecutive AF patients were enrolled ( 442 dabigatran , 478 acenocoumarol ) , of which 2 × 383 were available for analysis after propensity score matching . Mean follow-up duration was 1.5 ± 0.56 year . The mean calculated stroke risk according to the CHA2DS2-VASc score was 3.5%/year in dabigatran vs. 3.7%/year acenocoumarol-treated patients . The actual incidence rate of stroke or systemic embolism was 0.8%/year [ 95 % confidence interval ( CI ) : 0.2–2.1 ] vs. 1.0%/year ( 95 % CI : 0.4–2.1 ) , respectively . Multivariable analysis confirmed this lower but non-significant risk in dabigatran vs. acenocoumarol after adjustment for the CHA2DS2-VASc score [ hazard ratio (HR)dabigatran = 0.72 , 95 % CI : 0.20–2.63 , P = 0.61 ] . According to the HAS-BLED score , the mean calculated bleeding risk was 1.7%/year in both groups . Actual incidence rate of major bleeding was 2.1%/year ( 95 % CI : 1.0–3.8 ) in the dabigatran vs. 4.3%/year ( 95 % CI : 2.9–6.2 ) in acenocoumarol . This over 50 % reduction remained significant after adjustment for the HAS-BLED score ( HRdabigatran = 0.45 , 95 % CI : 0.22–0.93 , P = 0.031 ) . Conclusion In ‘ real-world ’ patients with AF , dabigatran appears to be as effective , but significantly safer than acenocoumarol Background — Dabigatran and warfarin have been compared for the treatment of acute venous thromboembolism ( VTE ) in a previous trial . We undertook this study to extend those findings . Methods and Results — In a r and omized , double-blind , double-dummy trial of 2589 patients with acute VTE treated with low-molecular-weight or unfractionated heparin for 5 to 11 days , we compared dabigatran 150 mg twice daily with warfarin . The primary outcome , recurrent symptomatic , objective ly confirmed VTE and related deaths during 6 months of treatment occurred in 30 of the 1279 dabigatran patients ( 2.3 % ) compared with 28 of the 1289 warfarin patients ( 2.2 % ; hazard ratio , 1.08 ; 95 % confidence interval [ CI ] , 0.64–1.80 ; absolute risk difference , 0.2 % ; 95 % CI , −1.0 to 1.3 ; P<0.001 for the prespecified noninferiority margin for both criteria ) . The safety end point , major bleeding , occurred in 15 patients receiving dabigatran ( 1.2 % ) and in 22 receiving warfarin ( 1.7 % ; hazard ratio , 0.69 ; 95 % CI , 0.36–1.32 ) . Any bleeding occurred in 200 dabigatran ( 15.6 % ) and 285 warfarin ( 22.1 % ; hazard ratio , 0.67 ; 95 % CI , 0.56–0.81 ) patients . Deaths , adverse events , and acute coronary syndromes were similar in both groups . Pooled analysis of this study RE-COVER II and the RE-COVER trial gave hazard ratios for recurrent VTE of 1.09 ( 95 % CI , 0.76–1.57 ) , for major bleeding of 0.73 ( 95 % CI , 0.48–1.11 ) , and for any bleeding of 0.70 ( 95 % CI , 0.61–0.79 ) . Conclusion — Dabigatran has similar effects on VTE recurrence and a lower risk of bleeding compared with warfarin for the treatment of acute VTE . Clinical Trial Registration — URL : www . clinical trials.gov . Unique identifiers : NCT00680186 and NCT00291330 Background — The R and omized Evaluation of Long-Term Anticoagulation Therapy ( RE-LY ) trial compared dabigatran 110 mg BID ( D110 ) and 150 mg BID ( D150 ) with warfarin for stroke prevention in 18 113 patients with nonvalvular atrial fibrillation . Methods and Results — Cardioversion on r and omized treatment was permitted . Precardioversion transesophageal echocardiography was encouraged , particularly in dabigatran-assigned patients . Data from before , during , and 30 days after cardioversion were analyzed . A total of 1983 cardioversions were performed in 1270 patients : 647 , 672 , and 664 in the D110 , D150 , and warfarin groups , respectively . For D110 , D150 , and warfarin , transesophageal echocardiography was performed before 25.5 % , 24.1 % , and 13.3 % of cardioversions , of which 1.8 % , 1.2 % , and 1.1 % were positive for left atrial thrombi . Continuous treatment with study drug for ≥3 weeks before cardioversion was lower in D110 ( 76.4 % ) and D150 ( 79.2 % ) compared with warfarin ( 85.5 % ; P<0.01 for both ) . Stroke and systemic embolism rates at 30 days were 0.8 % , 0.3 % , and 0.6 % ( D110 versus warfarin , P=0.71 ; D150 versus warfarin , P=0.40 ) and similar in patients with and without transesophageal echocardiography . Major bleeding rates were 1.7 % , 0.6 % , and 0.6 % ( D110 versus warfarin , P=0.06 ; D150 versus warfarin , P=0.99 ) . Conclusions — This study is the largest cardioversion experience to date and the first to evaluate a novel anticoagulant in this setting . The frequencies of stroke and major bleeding within 30 days of cardioversion on the 2 doses of dabigatran were low and comparable to those on warfarin with or without transesophageal echocardiography guidance . Dabigatran is a reasonable alternative to warfarin in patients requiring cardioversion . Clinical Trial Registration — URL : http://www . Clinical Trials.gov . Unique identifier : NCT00262600 Abstract Aims In patients with atrial fibrillation ( AF ) pharmacological or electrical cardioversion may be performed to restore sinus rhythm . The procedure is associated with an increased risk of thromboembolic events , which can be significantly reduced by adequate anticoagulation ( OAC ) . Our aim was to create a partly prospect i ve , partly retrospective cardioversion registry , particularly focusing on OAC strategies in different European countries , and on emerging choice of OAC over time . Methods From September 2014 to October 2015 , cardioversions due to AF performed in six European city hospitals in five European countries ( Hungary : Budapest-1 and -2 ; Italy : Bari and Pisa ; France : Amiens ; Spain : Madrid ; and Lithuania : Kaunas ) were recorded in the registry . Results A total of 1101 patients ( retrospective/ prospect i ve : 679/422 , male/female : 742/359 , mean age : 67.3 years ± 11.2 ) were registered . Most of the cardioversions were electrical ( 97 % ) . Oral anticoagulants were administered in 87 % of the patient , the usage of non-VKA oral anticoagulants ( NOACs ) vs Vitamin K antagonists ( VKA ) was 31.5 % vs 68.5 % , respectively . Seventy seven percent of the patients were given oral anticoagulants more than 3 weeks prior to the procedure , and 86 % more than 4 weeks after the procedure . When using VKA , international normalized ratio ( INR ) at cardioversion was above 2.0 in 76 % of the cases . A decline in VKA usage ( P = 0.033 ) in elective cardioversion over approximately 1 year was observed . During the observation period , there was an increase in apixaban ( P < 0.001 ) , a slight increase in rivaroxaban ( P = 0.028 ) and no changes in dabigatran ( P = 0.34 ) usage for elective cardioversion . There were differences in use of OAC between the countries : Spain used most VKA ( 89 % ) , while France used least VKA ( 39 % , P < 0.001 ) . Conclusion According to current AF guidelines , NOACs are adequate alternatives to VKA for thromboembolic prevention in AF patients undergoing elective cardioversion . Our results indicate that NOAC use is increasing and there is a significant decrease in VKA use Abstract Aim The primary objective was to compare apixaban to heparin/vitamin K antagonist ( VKA ) in patients with atrial fibrillation ( AF ) and ≤48 h anticoagulation prior to r and omization undergoing cardioversion . Methods One thous and five hundred patients were r and omized . The apixaban dose of 5 mg b.i.d . was reduced to 2.5 mg b.i.d . in patients with two of the following : age ≥ 80 years , weight ≤ 60 kg , or serum creatinine ≥ 133 µmol/L. To expedite cardioversion , at the discretion of the investigator , imaging and /or a loading dose of 10 mg ( down-titrated to 5 mg ) was allowed . The endpoints for efficacy were stroke , systemic embolism ( SE ) , and death . The endpoints for safety were major bleeding and clinical ly relevant non-major ( CRNM ) bleeding . Results There were 1038 active and 300 spontaneous cardioversions ; 162 patients were not cardioverted . Imaging was performed in 855 patients , and 342 received a loading dose of apixaban . Comparing apixaban to heparin/VKA in the full analysis set , there were 0/753 vs. 6/747 strokes [ relative risk ( RR ) 0 ; 95 % confidence interval ( 95 % CI ) 0–0.64 ; nominal P = 0.015 ] , no SE , and 2 vs. 1 deaths ( RR 1.98 ; 95 % CI 0.19–54.00 ; nominal P > 0.999 ) . In the safety population , there were 3/735 vs. 6/721 major ( RR 0.49 ; 95 % CI 0.10–2.07 ; nominal P = 0.338 ) and 11 vs. 13 CRNM bleeding events ( RR 0.83 ; 95 % CI 0.34–1.89 ; nominal P = 0.685 ) . On imaging , 60/61 with thrombi continued r and omized treatment ; all ( 61 ) were without outcome events . Conclusions Rates of strokes , systemic emboli , deaths , and bleeds were low for both apixaban and heparin/VKA treated AF patients undergoing cardioversion . Clinical Trials.gov number 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 Edoxaban is a direct oral factor Xa inhibitor with proven antithrombotic effects . The long-term efficacy and safety of edoxaban as compared with warfarin in patients with atrial fibrillation is not known . METHODS We conducted a r and omized , double-blind , double-dummy trial comparing two once-daily regimens of edoxaban with warfarin in 21,105 patients with moderate-to-high-risk atrial fibrillation ( median follow-up , 2.8 years ) . The primary efficacy end point was stroke or systemic embolism . Each edoxaban regimen was tested for noninferiority to warfarin during the treatment period . The principal safety end point was major bleeding . RESULTS The annualized rate of the primary end point during treatment was 1.50 % with warfarin (
Output:
| Conclusion DOACs peri-cardioversion in patients with AF appears safe from both a bleeding and thromboembolic risk perspective .
Available evidence supports the use of DOACs as st and ard of care peri-cardioversion in patients with AF |
MS213995 | ***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 — Surgical decompression reduces mortality and increases the probability of a favorable functional outcome after space-occupying hemispheric infa rct ion . Its cost-effectiveness is uncertain . Methods — We assessed clinical outcomes , costs , and cost-effectiveness for the first 3 years in patients who were r and omized to surgical decompression or best medical treatment within 48 hours after symptom onset in the Hemicraniectomy After Middle Cerebral Artery Infa rct ion With Life-Threatening Edema Trial ( HAMLET ) . Data on medical consumption were derived from case record files , hospital charts , and general practitioners . We calculated costs per quality -adjusted life year ( QALY ) . Uncertainty was assessed with bootstrapping . A Markov model was constructed to estimate costs and health outcomes after 3 years . Results — Of 39 patients enrolled within 48 hours , 21 were r and omized to surgical decompression . After 3 years , 5 surgical ( 24 % ) and 14 medical patients ( 78 % ) had died . In the first 3 years after enrollment , operated patients had more QALYs than medically treated patients ( mean difference , 1.0 QALY [ 95 % confidence interval , 0.6–1.4 ] ) , but at higher costs ( mean difference , & OV0556;127 000 [ 95 % confidence interval , 73 100–181 000 ] ) , indicating incremental costs of & OV0556;127 000 per QALY gained . Ninety-eight percent of incremental cost-effectiveness ratios replicated by bootstrapping were > & OV0556;80 000 per QALY gained . Markov modeling suggested costs of ≈&OV0556;60 000 per QALY gained for a patient ’s lifetime . Conclusions — Surgical decompression for space-occupying infa rct ion results in an increase in QALYs , but at very high costs . Clinical Trial Registration — URL : http://www.controlled-trials.com . Unique identifier : IS RCT N94237756 PURPOSE To assess the effectiveness and cost-effectiveness of state-of-the-art noninvasive diagnostic imaging strategies in patients with a transient ischemic attack ( TIA ) or minor stroke who are suspected of having carotid artery stenosis ( CAS ) . MATERIAL S AND METHODS All prospect ively evaluated patients provided informed consent , and the local ethics committee approved this study . Diagnostic performance , treatment , long-term events , quality of life , and costs result ing from strategies employing duplex ultrasonography ( US ) , computed tomographic ( CT ) angiography , contrast material -enhanced magnetic resonance ( MR ) angiography , and combinations of these modalities were modeled in a decision tree and Markov model . Data sources included a prospect i ve diagnostic cohort study , a meta- analysis , and a review of the literature . Outcomes were costs , quality -adjusted life-years ( QALYs ) , incremental cost-effectiveness ratios , and net health benefits ( QALY-equivalents ) , with a willingness-to-pay threshold of euro 50,000 per QALY and a societal perspective . The strategy with the highest net health benefit was considered the most cost effective . Extensive one-way , two-way , and probabilistic sensitivity analyses to explore the effect of varying parameter values were performed . The reference case analysis assumed that patients underwent surgery 2 - 4 weeks after the first symptoms , and the effect of earlier intervention was explored . RESULTS The reference case analysis showed that duplex US combined with CT angiography and surgery for 70%-99 % stenoses was the most cost-effective strategy , with a net health benefit of 13.587 and 15.542 QALY-equivalents in men and women , respectively . In men , the CT angiography strategy with a 70%-99 % cutoff yielded slightly more QALYs , at an incremental cost of euro 71,419 per QALY , compared with duplex US combined with CT angiography . In patients with a high-risk profile , in patients with a high prior probability of disease , and when patients could be treated within 2 weeks after the first symptoms , the CT angiography strategy with surgery for 50%-99 % stenoses was the most cost-effective strategy . CONCLUSION In diagnosing CAS , duplex US should be the initial test , and , if its results are positive , CT angiography should be performed ; patients with 70%-99 % stenoses should then undergo carotid endarterectomy . In patients with a high-risk profile , a high probability of CAS , or who can undergo surgery without delay , immediate CT angiography and surgery for 50%-99 % stenoses is indicated BACKGROUND Statins are lipid-lowering drugs that reduce the risk of cardiovascular events in patients with diabetes . OBJECTIVES The objective of this study was to determine whether statin treatment for primary prevention in newly diagnosed type 2 diabetes is cost-effective , taking nonadherence , baseline risk , and age into account . METHODS A cost-effectiveness analysis was performed by using a Markov model with a time horizon of 10 years . The baseline 10-year cardiovascular risk was estimated in a Dutch population of primary prevention patients with newly diagnosed diabetes from the Groningen Initiative to Analyse Type 2 Diabetes Treatment ( GIANTT ) data base , using the United Kingdom Prospect i ve Diabetes Study risk engine . Statin adherence was measured as pill days covered in the IADB.nl pharmacy research data base . Cost-effectiveness was measured in costs per quality -adjusted life-year ( QALY ) from the health care payers ' perspective . RESULTS For an average patient aged 60 years , the base case , statin treatment was highly cost-effective at € 2245 per QALY . Favorable cost-effectiveness was robust in sensitivity analysis . Differences in age and 10-year cardiovascular risk showed large differences in cost-effectiveness from almost € 100,000 per QALY to almost being cost saving . Treating all patients younger than 45 years at diabetes diagnosis was not cost-effective ( weighted cost-effectiveness of almost € 60,000 per QALY ) . CONCLUSIONS Despite the nonadherence levels observed in actual practice , statin treatment is cost-effective for primary prevention in patients newly diagnosed with type 2 diabetes . Because of large differences in cost-effectiveness according to different risk and age groups , the efficiency of the treatment could be increased by targeting patients with relatively higher cardiovascular risk and higher ages Objective : To evaluate the safety and cost-effectiveness of short-stay intensive care ( SSIC ) treatment for low-risk coronary artery bypass patients . Design : R and omized clinical equivalence trial . Setting : University Hospital Maastricht , the Netherl and s. Patients : Low-risk coronary artery bypass patients . Interventions : A total of 600 patients were r and omly assigned to undergo either SSIC treatment ( 8 hrs of intensive care treatment ) or control treatment ( care as usual , overnight intensive care treatment ) . Measurements : The primary outcome measures were intensive care readmissions and total hospital stay . The secondary outcome measures were total hospital costs , quality of life , postoperative morbidity , and mortality . Hospital costs consisted of the cost of hospital admission or admissions and outpatient costs . Main Results : The difference in intensive care readmission between the two groups of 1.13 % was very small and not significantly different ( p = .241 ; 95 % confidence interval , −0.9 % to 2.9 % ) . The total hospital stay ( p = .807 ; 95 % confidence interval , 1.2 to −0.4 ) and postoperative morbidity were comparable between the groups . The SSIC group 's quality of life improved more compared with the control group 's quality of life ( p = .0238 ; 95 % confidence interval , 0.0012 to 0.0464 ) . The total hospital costs for SSIC were significantly lower ( 95 % confidence interval , & U20AC;−1,581 to & U20AC;−174 ) compared with those for the control group ( & U20AC;4,625 and & U20AC;5,441 , respectively ) . The estimated incremental cost-effectiveness ratio ( cost/delta quality -adjusted life months ) thus showed the dominance of SSIC . Bootstrap and sensitivity analyses confirm the robustness of the study findings . Conclusions : Compared with usual care , SSIC is a safe and cost-effective approach . SSIC can be considered as an alternative for conventional postoperative intensive care treatment for low-risk coronary artery bypass graft patients Objective This study aims to systematic ally evaluate available evidence regarding direct medical costs of treating cardiovascular ( CV ) events in Germany after 2003 on an individual patient basis and from a payer perspective . The CV events of interest were myocardial infa rct ion ( MI ) , unstable angina , heart failure ( HF ) , stroke , and peripheral artery disease ( PAD ) . Method A systematic literature search was performed in the following data bases according to Preferred Reporting Items for Systematic Review s and Meta- Analysis ( PRISMA ) guidelines - Medline , Embase , Centre for Review s and Dissemination , TIBORDER , and German dissertation data base from January 2003 to October 2013 . Both observational studies and r and omized clinical trials were considered for the review . All values stated in € are inflation adjusted to 2014 € unless stated otherwise . Result This review included 13 articles . For newly occurred MI patients , the average hospitalization costs during the acute phase were reported to be between € 6790 and € 8918 per admission . In the first year after a MI event , direct medical costs were € 13,838–14,792 per patient . Direct medical costs of chronic HF patients were found to be between € 3417 and 5576 per patient per year . Treatment costs increase with disease progression . The average treatment costs for hospitalized PAD in the acute phase were reported to be € 4963 per admission , € 2535 per patient during month 1–6 after the initial hospitalization , € 1601 in month 7–12 , and € 1390 in month 13–18 . For stroke of all types , total direct medical costs in the 1st year after an event were reported to be € 13,273 per patient . Total direct medical costs during the 1st year after an ischemic stroke event were € 17,399–21,954 per patient , € 6260 in month 13–18 , and € 6496 per year in the subsequent 4 years . Conclusion MI , unstable angina , HF , stroke and PAD have a high financial impact on the German health care system . Treatment costs of these diseases are mostly incurred during the acute phase of events and tend to decrease over time . Hospitalization and rehabilitation costs were two major cost drivers . Medication costs was one of the smallest cost component reported BACKGROUND Despite the growing interest in haemodiafiltration ( HDF ) , there is no information on the costs and cost-utility of this dialysis modality yet . It was therefore our objective to study the cost-utility of HDF versus haemodialysis ( HD ) . METHODS A cost-utility analysis was performed using a Markov model . It included data from the Convective Transport Study ( CONTRAST ) , a r and omized controlled trial that compared online HDF with low-flux HD . Costs were estimated using a societal perspective . Probabilistic sensitivity analyses were performed to study uncertainty . RESULTS Total annual costs for HDF and HD were € 88 622±19,272 and € 86,086±15,945 , respectively ( in 2009 euros ) . When modelled over a 5-year period , the incremental cost per quality -adjusted life year ( QALY ) of HDF versus HD was € 287,679 . Sensitivity analyses revealed that this amount will not fall below € 140,000 , even under the most favourable assumptions like a high-convection volume ( > 20.3 L ) . CONCLUSIONS Based on accepted societal willingness-to-pay thresholds , HDF can not be considered a cost-effective treatment for patients with end-stage renal disease at present . Apparently , minor additional costs of HDF are not counterbalanced by a relevant QALY gain Background Economic evaluation of stroke services indicates that such services may lead to improved quality of life at affordable cost . The present study assesses lifetime health impact and cost consequences of stroke in an integrated service setting . Methods The EDISSE study is a prospect i ve non-r and omized controlled cluster trial that compared stroke services ( n = 151 patients ) to usual care ( n = 187 patients ) . Health status and cost trial- data were entered in multi-dimensional stroke life-tables . The tables distinguish four levels of disability which are defined by the modified Rankin scale . Quality -of-life scores ( EuroQoL-5D ) , transition and survival probabilities are based on concurrent Dutch follow-up studies . Outcomes are quality -adjusted life years lived and lifetime medical cost by disability category . An economic analysis compares outcomes from a successful stroke service to usual care , by bootstrapping individual costs and effects data from patients in each arm . Results Lifetime costs and QALYs after stroke depend on age-of-onset of first-ever stroke . Lifetime QALYs after stroke are 2.42 ( 90 % CI - 0.49 - 2.75 ) for male patients in usual care and 2.75 ( -0.61 ; 6.26 ) for females . Lifetime costs for men in the usual care setting are € 39,335 ( 15,951 ;
Output:
| The most expensive clinical events were related to renal failure , while TIA was the least expensive event .
Generally , there was substantial variation in reported cost estimates for T2DM-related events . |
MS213996 | ***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 was design ed to determine the accuracy of the Ottawa Knee Rule ( OKR ) when applied to patients with acute knee injury in the Iranian population of the Imam Hospital Emergency Department ( ED ) at . Methods This prospect i ve cohort validation study included a convenience sample of all patients with a blunt knee injury sustained in the preceding 7 days presenting to the ED of a tertiary care teaching hospital during the study period . Patients were assessed for the five variables comprising the OKR , and a st and ardised data form was completed for each patient . St and ard knee radiographs were ordered on all patients irrespective of the determination of the rule . The rules were interpreted by the primary investigator on the basis of the data sheet and the final orthopaedist radiograph reading . Outcome measures of this study were : sensitivity , specificity , positive predictive value and negative predictive value of the OKR . Results A total of 283 patients were enrolled in the study . 22 fractures ( 7.77 % ) were detected . The decision rule had a sensitivity of 0.95 ( 95 % CI 0.77 to 0.99 ) , and a specificity of 0.44 ( 95 % CI 0.37 to 0.50 ) . The potential reduction in use of radiography was estimated to be 41 % . The OKR missed only one fracture . Conclusion Prospect i ve validation has shown that the OKR is a highly sensitive tool for detecting knee fractures and has the potential to reduce the number of radiographs in patients with acute knee injuries OBJECTIVE To determine interobserver agreement between triage registered nurses ( RNs ) and emergency physicians ( EPs ) regarding indication for knee radiographs by applying the Ottawa knee rule ( OKR ) and individual components of the rule . METHODS This was a prospect i ve , observational study in a suburban , teaching emergency department . The study enrolled a convenience sample of patients aged > 17 years with traumatic knee injuries less than one week old . Patients with prior knee surgery or distracting conditions were excluded . Before study initiation , the RNs and EPs were in-serviced in the OKR . Nurses and EPs independently examined each patient for OKR criteria , blinded to the other 's assessment . Knee radiographs were ordered at the discretion of the EP and were interpreted by board-certified radiologists . All patients received follow-up with a structured telephone interview to identify any undetected fractures . Kappa was calculated for each component and the overall application of the OKR to assess interobserver agreement . RESULTS Ninety-six patients were enrolled . The mean age was 39.6 + /- 18.7 years ; 50 % were male . Eight patients ( 8 % ) had knee fractures . Interobserver agreements between the RNs and EPs for individual components of the OKR were : age > or = 55 years ( kappa = 0.97 ) ; inability to weight bear ( kappa = 0.51 ) ; inability to bend knee to 90 degrees ( kappa = 0.52 ) ; fibular head tenderness ( kappa = 0.45 ) ; and isolated patellar tenderness ( kappa = 0.40 ) . The EPs and RNs agreed with OKR criteria for x-ray 71 % of the time ( kappa = 0.41 ) . CONCLUSIONS The only criterion that result ed in almost perfect agreement between the RNs and EPs was patient age ; agreement for the other four criteria and the overall decision to order x-rays was moderate OBJECTIVE To vali date a previously derived decision rule for the use of radiography in patients with acute knee injury . DESIGN Prospect ively administered survey . SETTING Emergency departments of two university hospitals serving adults . PATIENTS Convenience sample of 1096 of 1251 eligible adults with acute knee injuries ; 124 patients were examined by two physicians . MAIN OUTCOME MEASURES Attending emergency physicians assessed each patient for st and ardized clinical variables and determined the need for radiography according to the decision rule . Patients who did not have radiography underwent a structured telephone interview at day 14 to determine the possibility of a fracture . The rule was assessed for ability to correctly identify the criterion st and ard , fracture of the knee . An attempt was made to refine the rule by means of univariate and recursive partitioning analyses . RESULTS The decision rule had a sensitivity of 1.0 ( 95 % confidence interval [ CI ] , 0.94 to 1.0 ) for identifying 63 clinical ly important fractures . Physicians correctly interpreted the rule in 96 % of cases , and the k value for interpretation was 0.77 ( 95 % CI , 0.65 to 0.89 ) . The potential relative reduction in use of radiography was estimated to be 28 % . The probability of fracture , if the decision rule were " negative , " is estimated to be 0 % ( 95 % CI , 0 % to 0.4 % ) . Attempts to refine the rule led to a model with improved specificity but with an unacceptable loss of sensitivity . CONCLUSION Prospect i ve validation has shown this decision rule to be 100 % sensitive for identifying fractures of the knee , to be reliable and acceptable , and to have the potential to allow physicians to reduce the use of radiography in patients with acute knee injury Abstract . Our objective was to determine the value of the Ottawa knee rules when applied by users with different levels of clinical training . We used a prospect i ve patient survey by the medical students and surgery residents of a European university trauma centre . The study group consisted of 261 eligible patients who presented with acute knee trauma during a 6-month period . Radiography or follow-up was obtained for each patient . Data were separately analysed according to the degree of qualification of the initial examiner . The Ottawa knee rules had a sensitivity and a negative predictive value of 1.00 . Variable degree of medical competence of the users did not alter the accuracy of the rules . Application of the rules would have reduced knee radiography requests by 25 % . The Ottawa knee rules remain highly sensitive when applied by medical users with different levels of qualification , such as encountered in a teaching setting STUDY OBJECTIVE To derive a highly sensitive decision rule for the selective use of radiography in acute knee injuries . DESIGN Prospect ively administered survey . SETTING Emergency departments of two university hospitals . PARTICIPANTS Convenience sample of 1,047 adults with acute knee injuries . RESULTS Attending emergency physicians assessed each patient for 23 st and ardized clinical findings , which were recorded on data collection forms . A total of 127 patients was examined independently by two physicians to determine interobserver agreement . The outcome measure was fracture of the knee . Any patients who did not have ED radiography underwent a structured telephone interview to determine the possibility of a missed fracture . Those variables found to be both reliable ( highest kappa values ) and strongly associated with a fracture ( highest chi 2 values ) were further analyzed by a recursive-partitioning multivariate technique . The derived decision rule included the following variables : ( 1 ) age 55 years or older , ( 2 ) tenderness at the head of the fibula , ( 3 ) isolated tenderness of the patella , ( 4 ) inability to flex to 90 degrees , and ( 5 ) inability to bear weight both immediately and in the ED ( four steps ) . The presence of one or more of these findings would have identified the 68 fractures in the study population with a sensitivity of 1.0 ( 95 % confidence interval [ Cl ] , .95 to 1.0 ) and a specificity of .54 ( 95 % Cl , .51 to .57 ) . Application of the rule would have led to a 28.0 % relative reduction in the use of radiography from 68.6 % to 49.4 % in the study population . CONCLUSION A practical , highly sensitive , and reliable decision rule for the use of radiography in acute knee injuries has been derived . Clinical application should await prospect i ve validation of the rule OBJECTIVES To study : 1 ) the efficiency of the current use of radiography in acute knee injuries , 2 ) the judgments and attitudes of experienced clinicians in their use of knee radiography , and 3 ) the potential for decision rules to improve efficiency . METHODS This two-stage study of adults with acute knee injuries involved : 1 ) a retrospective review of all 1,967 patients seen over a 12-month period in the EDs of one community and two teaching hospital , and 2 ) a prospect i ve survey of another 1,040 patients seen by attending emergency physicians . The prospect i ve survey assessed each clinician 's estimate of the probability of a knee or patella fracture ; 120 patients were independently assessed by two physicians . RESULTS Of the 1,967 patients seen in the first stage , 74.1 % underwent radiography but only 5.2 % were found to have fractures . Of the 1,727 knee and patella radiographic series ordered , 92.4 % were negative for fracture . In the second stage , experienced physicians predicted the probability of fracture to be 0 or 0.1 for 75.6 % of the patients . The kappa value for this response was 0.51 ( 95 % CI 0.34 to 0.68 ) . The physicians also indicated that they would have been comfortable or very comfortable in not ordering radiography for 55.5 % of the patients . The area under the receiver operating characteristics curve for the physicians ' prediction of fracture was 0.87 ( 95 % CI 0.82 to 0.91 ) , reflecting good discrimination between fracture and nonfracture cases . Likelihood ratios for the physicians ' prediction ranged from 0.09 at the 0 level to 42.9 at the 0.9 - 1.0 level . CONCLUSIONS Emergency physicians order radiography for most patients with acute knee injuries , even though they can accurately discriminate between fracture and nonfracture cases and expect most of the radiographs to be normal . These findings suggest great potential for more efficient use of knee radiography , possibly through the use of a clinical decision rule We design ed a prospect i ve observational study to attempt to vali date two recently described clinical decision rules for knee radiography . Consecutive patients aged > or = 15 yr with acute knee injuries occurring less than 1 wk prior to presentation were included for study . Patients with distracting conditions , open knee injuries , or previous surgery were excluded . Each patient was assessed for 7 historical and 15 physical examination criteria that were recorded on a st and ardized data collection instrument . Radiographs were ordered at the discretion of the attending physician and were read by two board-certified radiologists . When radiographs were not ordered , structured telephone follow-up was performed after 3 wk . The main outcome parameter was the presence or absence of a clinical ly significant fracture . There were 351 patients in the study ; 26 ( 7 % ) had knee fractures . Fractures were significantly associated with an increased prevalence for two of the three criteria in the rule derived by Bauer : inability to weight bear immediately or in the emergency department ( ED ; 76.9 % of patients with a fracture vs. 29.8 % of patients without a fracture ) and effusion ( 53.8 % vs. 28.9 % , respectively ) . Ecchymosis was not significantly associated with fracture ( 19.2 % with fracture vs. 9 % with no fracture ) . Use of the Bauer rule would have led to a radiographic evaluation of 22 of the 26 patients with knee fractures ( sensitivity = 84.6 % , specificity = 48.9 % ) . Fractures were associated with a significantly increased prevalence for three of the five criteria in the decision rule proposed by Stiell : isolated patella tenderness ( 30.8 % with fracture vs. 14.5 % with no fracture ) , inability to flex the knee to 90 degrees ( 42.3 % vs. 19.7 % , respectively ) , and inability to weight bear immediately and in the ED ( 57.7 % vs. 18.8 % , respectively ) . Age > or = 55 yr ( 23.1 % vs. 12.0 % , respectively ) and fibula head tenderness ( 11.5 % vs. 5.5 % , respectively ) were not significantly associated with fracture . Use of the Stiell rule would have led to radiographic evaluation of 22 of the 26 patients with knee fractures ( sensitivity = 84.6 % , specificity = 49.8 % ) . We conclude that neither clinical decision rule is 100 % sensitive . Further refinement will be necessary to identify all patients with knee fractures CONTEXT The Ottawa Knee Rule is a previously vali date d clinical decision rule that was developed to allow physicians to be more selective and efficient in their use of plain radiography for patients with acute knee injuries . OBJECTIVE To assess the impact on clinical practice of implementing the Ottawa Knee Rule . DESIGN Controlled clinical trial with before-after and concurrent controls . SETTING Emergency departments of 2 teaching and 2 community hospitals . PATIENTS All 3907 consecutive eligible adults seen with acute knee injuries during two 12-month periods before and after the intervention . INTERVENTION During the after period in the 2 intervention hospitals , the Ottawa Knee Rule was taught to all house staff and attending physicians who were encouraged to order knee radiography according to the rule . MAIN OUTCOME MEASURES Referral for knee radiography , accuracy and reliability of the rule , mean time in emergency department , and mean charges . RESULTS There was a relative reduction of 2
Output:
| Application of the OKR can rule out knee fracture and thus avoid unnecessary radiography .
These results also translate to improved efficiency , lower medical costs and reduced waiting times .
• The Ottawa Knee Rule helps clinicians to rule out fracture in adults with an acute knee injury .
• The rule allows a reduction in radiography requests , patient waiting time in the emergency department and healthcare costs |
MS213997 | ***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: Animal data suggest that a D1 antagonistic component in neuroleptic drugs counteracts development of dopamine supersensitivity and of tolerance to cataleptic effect . This has led to the hypothesis that neuroleptics with D1 antagonistic activity should cause a better suppression of tardive dyskinesia ( TD ) and less rebound aggravation after withdrawal than pure D2 antagonists . In this study the effect of zuclopenthixol ( mixed D1/D2 antagonist ) and haloperidol ( D2 antagonist ) was evaluated in chronic psychotic patients with TD . Fifteen patients completed a r and omized crossover study with blind evaluation of TD and parkinsonism . The test medications , haloperidol and zuclopenthixol , caused a significant suppression of TD and a significant increase of parkinsonism . No significant differences between haloperidol and zuclopenthixol were observed . No TD aggravation was seen . The lack of differences between the mixed D1/D2 antagonist and a D2 antagonist suggest that tolerance and DA supersensitivity play no or a minor role for development of TD Eleven patients with tardive dyskinesia were treated with lithium carbonate in a placebo-controlled double-blind crossover study . No significant effect of lithium on either tardive dyskinesia or blood prolactin concentrations was demonstrated , but 5 patients developed pseudo-Parkinsonian features In a double-blind , placebo-controlled study , ten chronic schizophrenic patients with pronounced symptoms of tardive dyskinesia ( TD ) were withdrawn from anticholinergic medication . All patients had previously been under long-term treatment with neuroleptics and anticholinergics for at least two years . The rating-scales used were the AIMS , our own TD Scale , and the Simpson-Angus scale for extra-pyramidal side-effects . The severity of TD decreased significantly in nine patients with in two weeks ; this improvement , most pronounced in the oral region ( P less than .001 ) , persisted during a six-week placebo period . There was a slight increase in parkinsonian symptoms ( P less than .05 ) , which was not a prerequisite for improvement in TD . Hence , discontinuation of anticholinergic medication is a possible therapeutic approach in patients with TD A study was conducted to investigate a novel approach to the prophylaxis of schizophrenic relapse . The treatment strategy comprised brief intermittent courses of neuroleptic agents begun as soon as non-psychotic symptoms believed to be early signs of relapse appeared . Fifty four stable , remitted out patients meeting the American Psychiatric Association 's DSM-III criteria for schizophrenia were r and omised double blind to receive brief intermittent treatment with either active or placebo depot neuroleptic injections . Only three patients given placebo injections and two controls were admitted to hospital during one year of follow up . Eight ( 30 % ) of the patients given placebo injections and only 2 ( 7 % ) of the controls , however , had a recurrence of schizophrenic symptoms . Patients given placebo injections experienced fewer extrapyramidal side effects and showed a trend towards a reduction in tardive dyskinesia . Dysphoric and neurotic symptoms were identified before eight out of 11 relapses , and these symptoms were more frequent in patients given placebo depot injections . These results suggest a viable but not necessarily better alternative to continuous oral or depot treatment for less ill , chronic , stabilised schizophrenics based on the early treatment of putative prodromal symptoms of relapse BACKGROUND While the atypical antipsychotics should ultimately reduce the prevalence of tardive dyskinesia , it is likely to remain a significant clinical problem for a long time to come . No strategy has clearly emerged as the treatment of choice for tardive dyskinesia . Atypical antipsychotics have reduced propensities for producing acute extrapyramidal symptoms ( EPS ) and possibly tardive dyskinesia and may be effective in treating patients with established tardive dyskinesia . METHOD This 12-month , r and omized , investigator-blinded study compared the efficacy of quetiapine ( N = 22 ) and haloperidol ( N = 23 ) in treating patients with DSM-IV schizophrenia or schizoaffective disorder and established tardive dyskinesia . Dyskinesia was assessed using the Extrapyramidal Symptom Rating Scale ( ESRS ) dyskinesia subscale scores and the Clinical Global Impression ( CGI ) dyskinesia scores . Other EPS , weight , serum prolactin level , and glycosylated hemoglobin level were also assessed . Subjects were enrolled in the study between April 2000 and March 2002 . RESULTS Mean endpoint doses were 400 mg/day of quetiapine and 8.5 mg/day of haloperidol . Compared with the haloperidol group , the quetiapine group showed significantly greater improvements in ESRS dyskinesia ( 6 and 9 months [ p < or=.01 ] ) and CGI dyskinesia ( from 6 months onward [ p < .05 ] and with repeated- measures analysis [ p = .002 ] ) . Response rate ( > or= 50 % symptom reduction ) was greater with quetiapine than haloperidol ( 64 % [ 9/14 ] and 37 % [ 6/16 ] at 6 months ; 55 % [ 6/11 ] and 28 % [ 4/14 ] at 12 months ) . Other EPS decreased significantly with quetiapine at 3 ( p = .01 ) , 6 ( p = .01 ) , and 9 ( p = .002 ) months . Serum prolactin levels decreased with quetiapine but increased with haloperidol , differing significantly between the groups at endpoint ( p = .005 ) . No significant changes in weight or glucose metabolism were recorded in either group . CONCLUSION Quetiapine effectively reduces the severity of tardive dyskinesia and is well tolerated in patients with established tardive dyskinesia Clozapine has long been considered a useful treatment in patients who have schizophrenia with the neuroleptic-induced delayed-onset side effect tardive dyskinesia . We present data in support of the clinical impression using both an animal model of the disorder and dyskinetic patients themselves . Clozapine produces a lower rate of oral dyskinesia in laboratory rats after 6 months of chronic treatment than does haloperidol ( 8.6 + /- 1.3 vs. 13.6 + /- 1.4 vacuous chewing movements every 5 minutes , respectively ) , suggesting a lower propensity to cause tardive dyskinesia . In the human , when clozapine was compared with haloperidol in the treatment of patients with tardive dyskinesia , clozapine produced significantly greater benefit for motor symptoms after 12 months of treatment than did haloperidol ( p < .001 ) . Moreover , the dyskinesia rebound , which occurred equally in both drug groups at the beginning of the study , was sustained in the haloperidol group but lost in the clozapine-treated patients . These data suggest that dyskinetic patients lose their symptoms of tardive dyskinesia , along with dopaminergic hypersensitivity , with long-term clozapine treatment A comparison of the features of persistent oral dyskinesia and functional oral movements is made . The literature on the drug control of oral dyskinesia is review ed . In a double-blind interrupted cross-over trial in two established cases of oral dyskinesia , thiopropazate dihydrochloride was found to be highly effective An experimental method was utilized to compare the masking effects of two neuroleptic agents -- molindone and haloperidol -- on 18 neuroleptic-treated schizophrenic patients exhibiting operationally defined withdrawal-exacerbated tardive dyskinesia . After a week on one of these two medications at preestablished doses equivalent to that of the pre- study neuroleptic , molindone-masked total AIMS scores by significantly less ( 12 % ) than haloperidol ( 27 % ) . Similarly , during a second week when the dose of these neuroleptics was equivalent to 200 % that of the pre- study dose , molindone masked the total AIMS score significantly less ( 23 % ) as compared to haloperidol ( 53 % ) . Several interpretations of this finding are considered . This study demonstrates the feasibility of a method that may offer a model for underst and ing pharmacological differences among neuroleptic medications The authors estimated components of variance and intraclass correlation coefficients ( ICCs ) to aid in the design of complex surveys and community intervention studies by analyzing data from the Health Survey for Engl and 1994 . This cross-sectional survey of English adults included data on a range of lifestyle risk factors and health outcomes . For the survey , households were sample d in 720 postal code sectors nested within 177 district health authorities and 14 regional health authorities . Study subjects were adults aged 16 years or more . ICCs and components of variance were estimated from a nested r and om-effects analysis of variance . Results are presented at the district health authority , postal code sector , and household levels . Between-cluster variation was evident at each level of clustering . In these data , ICCs were inversely related to cluster size , but design effects could be substantial when the cluster size was large . Most ICCs were below 0.01 at the district health authority level , and they were mostly below 0.05 at the postal code sector level . At the household level , many ICCs were in the range of 0.0 - 0.3 . These data may provide useful information for the design of epidemiologic studies in which the units sample d or allocated range in size from households to large administrative areas Fluperlapine , a new clozapine-like neuroleptic drug with weak affinity for dopamine receptors , was evaluated in a blind , placebo controlled trial in 11 patients with stable hyperkinesia ( ten with tardive dyskinesia ( TD ) and one with spontaneous dyskinesia ) . Drug effects during active treatment ( 200–600 mg/day ) and during pre- and post-treatment placebo periods were determined by scoring r and omly sequenced videotapes of TD and parkinsonian symptoms recorded weekly during st and ardized examinations . TD score was unchanged , while parkinsonism slightly decreased ( P<0.05 ) and eye-blinking rates increased ( P<0.05 ) . Psychiatric symptoms showed no significant changes , although positive psychotic symptoms diminished in four patients . Side effects included dizziness , sedation and constipation . The effects in movement disorders found in this study may imply that fluperlapine is less liable than traditional neuroleptics to induce acute extrapyramidal side effects and tardive dyskinesia and is particularly beneficial in the treatment of patients vulnerable to neurological side-effects We sought to determine whether such state-related factors as neuroleptic treatment and facio-oral tardive dyskinesia ( TD ) influence smooth-pursuit eye movement ( SPEM ) in chronic schizophrenics . The design involved 100 schizophrenics , 64 of whom showed " abnormal " eye tracking . Experimentally drug-withdrawn patients , some of whom were clinical ly relapsed , were compared with control patients who continued taking medication in prewithdrawal and postwithdrawal SPEM tests . All groups showed a slight worsening in eye-tracking performance on two postwithdrawal tests , but significant group-by-test session " interactions " were not demonstrable . We also determined that patients with TD tend to substitute large , nontracking saccades for SPEM to a significantly greater extent than nondyskinetic patients . Our findings strengthen the supposition that impaired SPEM is a trait in many schizophrenics but suggest that patients with TD be excluded in future studies of SPEM addressed to trait issues Clozapine , which has had limited clinical testing in the U.S.A. , was evaluated in 12 chronic schizophrenic patients with tardive dyskinesia . Its antipsychotic activity was again demonstrated and it suppressed the symptoms of tardive dyskinesia with a marked rebound occurring in these symptoms when it was withdrawn ; there was no rigidity or other Parkinsonian symptoms . However , out of a total of 12 patients , neutropenia ( 800 and 1120 ) occurred in two patients , convulsions in one patient , marked withdrawal effects in three patients , and a hypotensive collapse with atrial fibrillation in one patient . If these adverse effects are confirmed in a larger sample size , then despite the novel desirable effects of clozapine it would seem unlikely that it will gain widespread or routine use1 BACKGROUND Amisulpride is a potent substituted benzamide antipsychotic drug cl aim ed to improve the negative symptoms of schizophrenia , particularly at low dosage . METHOD Sixty long-term in- patients with schizophrenia and selected for predominant negative symptoms were r and omised to receive either haloperidol or amisulpride . Over a year there was systematic dose reduction , as symptoms allowed . RESULTS There were no significant differences between the treatment groups in the proportion receiving low-dose treatment , the control of positive symptoms , or ratings of social behaviour , side-effects or tardive dyskinesia . For negative symptoms , there were consistent but non-significant trends in favour of amisulpride . The amisulpride patients required significantly less anticholinergic medication . CONCLUSIONS In chronically-hospitalised in- patients with schizophrenia characterised by persistent negative symptoms , amisulpride was a well-tolerated maintenance antipsychotic medication . The drug had only a limited effect in reducing negative symptoms , which were relatively stable , enduring phenomena in this sample , despite dosage reduction Eleven patients with Huntington 's disease and nine patients with tardive dyskinesia participated in a r and omised double-bl
Output:
| AUTHORS ' CONCLUSIONS Limited data from small studies using neuroleptic reduction or specific neuroleptic drugs as treatments for TD did not provide any convincing evidence of the value of these approaches . |
MS213998 | ***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 acute administration of atorvastatin has been reported to reduce myocardial infa rct size in animal studies . However , this cardioprotective effect is lost with the chronic administration of atorvastatin , although it can be recaptured by administering an acute high-dose of atorvastatin . We hypothesised that pre-treatment with high-dose atorvastatin , on a background of chronic st and ard ‘ statin ’ therapy , would reduce myocardial injury in patients undergoing elective coronary artery bypass graft ( CABG ) surgery . One hundred and one consenting patients undergoing elective CABG surgery at a single tertiary cardiac centre were recruited into two r and omised controlled , single-blinded clinical studies . Study 1 : 45 patients were r and omised to receive either 160 mg of atorvastatin 2 h preoperatively and 24 h following surgery or their st and ard statin therapy . Study 2 : 56 patients were r and omised to receive either 160 mg of atorvastatin 12 h preoperatively and 24 h following surgery or their st and ard statin therapy . Blood sample s for troponin T and creatine kinase were taken prior to surgery and then at 6 , 12 , 24 , 48 and 72 h post-surgery . Cardiac enzyme levels at each time point and the total area-under curve ( AUC ) were calculated . The group characteristics and surgical methods were well matched . High-dose atorvastatin was not associated with any significant side effects . There was no significant difference in serum troponin T or creatine kinase in either study at each time point or over 72 h. Study 1 : AUC , troponin T : atorvastatin 29.6 ± 34.8 μg/L versus control 25.0 ± 22.0 μg/L : P > 0.05 . Creatine kinase : atorvastatin 33,544 ± 20,063 IU/L versus control 30,620 ± 10,776 IU/L : P > 0.05 . Study 2 : AUC , troponin T : atorvastatin 21.8 ± 14.3 μg/L versus control 20.9 ± 8.7 μg/L : P > 0.05 . Creatine kinase : atorvastatin 36,262 ± 28,821 IU/L versus control 33,448 ± 14,984:P > 0.05 . There were no differences in postoperative outcomes . We report that the administration of high-dose atorvastatin to low risk patients undergoing elective CABG surgery , who are already on st and ard dose ‘ statin ’ therapy is safe , but does not further reduce perioperative myocardial injury Purpose Statins , 3-hydroxy-3-methylglutaryl coenzyme A ( HMG-CoA ) reductase inhibitors have the potential to reduce acute kidney injury ( AKI ) after cardiac surgery through their pleiotropic properties . Here we studied the preventive effect of atorvastatin on AKI after valvular heart surgery . Methods Two-hundred statin-naïve patients were r and omly allocated to receive either statin or placebo . Atorvastatin was administered orally to the statin group according to a dosage schedule ( 80 mg single dose on the evening prior to surgery ; 40 mg on the morning of surgery ; three further doses of 40 mg on the evenings of postoperative days 0 , 1 , and 2 ) . AKI incidence was assessed during the first 48 postoperative hours on the basis of Acute Kidney Injury Network criteria . Results The incidence of AKI was similar in the statin and control groups ( 21 vs. 26 % , respectively , p = 0.404 ) . Biomarkers of renal injury including plasma neutrophil gelatinase-associated lipocalin and interleukin-18 were also similar between the groups . The statin group required significantly less norepinephrine and vasopressin during surgery , and fewer patients in the statin group required vasopressin . There were no significant differences in postoperative outcomes . Conclusions Acute perioperative statin treatment was not associated with a lower incidence of AKI or improved clinical outcome in patients undergoing valvular heart surgery . ( Clinical Trials.gov NCT01909739 ) BACKGROUND Neutrophils play a central role in systemic inflammatory reaction after cardiopulmonary bypass . Apoptosis is significantly delayed , and this might exacerbate systemic and myocardial damage . We tested the hypothesis of whether pretreatment with simvastatin increases the apoptotic rate of neutrophils and hence reduces the entity of inflammatory reaction . METHODS Thirty patients undergoing coronary surgery with cardiopulmonary bypass were r and omized to treatment with either simvastatin ( 40 mg/day ) or placebo for 3 weeks before surgery . A group of 15 patients undergoing off-pump coronary surgery served as controls . Blood sample s for detection of serum cytokine levels were obtained before anesthesia , at the end of surgery , and at 4 , 24 , 48 , and 72 hours postoperatively . Apoptosis and indices of activation were assessed in cultured neutrophils . RESULTS Simvastatin significantly reduced the postoperative peak values of interleukin (IL)-6 and IL-8 . The neutrophil apoptotic rate was significantly higher among neutrophils obtained from patients pretreated with simvastatin ( p < 0.05 at both 8 and 24 hours ) compared with placebo . Neutrophils from the statin group had depressed functional activity , as underscored by significantly lower values of CD11b ( p < 0.01 at 24 hours ) and a significantly less percentage of cells positive for nitro-blue tetrazolium ( p < 0.01 at 12 and 24 hours ) compared with placebo . CONCLUSIONS This r and omized , double-blind study indicates that statin therapy before cardiopulmonary bypass is associated with reduction of circulating markers of inflammation and increased neutrophil apoptosis . These data support a routine inclusion of statins as an adjuvant pharmacologic therapy before cardiopulmonary bypass surgery IMPORTANCE Statins affect several mechanisms underlying acute kidney injury ( AKI ) . OBJECTIVE To test the hypothesis that short-term high-dose perioperative atorvastatin would reduce AKI following cardiac surgery . DESIGN , SETTING , AND PARTICIPANTS Double-blinded , placebo-controlled , r and omized clinical trial of adult cardiac surgery patients conducted from November 2009 to October 2014 at V and erbilt University Medical Center . INTERVENTIONS Patients naive to statin treatment ( n = 199 ) were r and omly assigned 80 mg of atorvastatin the day before surgery , 40 mg of atorvastatin the morning of surgery , and 40 mg of atorvastatin daily following surgery ( n = 102 ) or matching placebo ( n = 97 ) . Patients already taking a statin prior to study enrollment ( n = 416 ) continued taking the preenrollment statin until the day of surgery , were r and omly assigned 80 mg of atorvastatin the morning of surgery and 40 mg of atorvastatin the morning after ( n = 206 ) or matching placebo ( n = 210 ) , and resumed taking the previously prescribed statin on postoperative day 2 . MAIN OUTCOMES AND MEASURES Acute kidney injury defined as an increase of 0.3 mg/dL in serum creatinine concentration within 48 hours of surgery ( Acute Kidney Injury Network criteria ) . RESULTS The data and safety monitoring board recommended stopping the group naive to statin treatment due to increased AKI among these participants with chronic kidney disease ( estimated glomerular filtration rate < 60 mL/min/1.73 m2 ) receiving atorvastatin . The board later recommended stopping for futility after 615 participants ( median age , 67 years ; 188 [ 30.6 % ] were women ; 202 [ 32.8 % ] had diabetes ) completed the study . Among all participants ( n = 615 ) , AKI occurred in 64 of 308 ( 20.8 % ) in the atorvastatin group vs 60 of 307 ( 19.5 % ) in the placebo group ( relative risk [ RR ] , 1.06 [ 95 % CI , 0.78 to 1.46 ] ; P = .75 ) . Among patients naive to statin treatment ( n = 199 ) , AKI occurred in 22 of 102 ( 21.6 % ) in the atorvastatin group vs 13 of 97 ( 13.4 % ) in the placebo group ( RR , 1.61 [ 0.86 to 3.01 ] ; P = .15 ) and serum creatinine concentration increased by a median of 0.11 mg/dL ( 10th-90th percentile , -0.11 to 0.56 mg/dL ) in the atorvastatin group vs by a median of 0.05 mg/dL ( 10th-90th percentile , -0.12 to 0.33 mg/dL ) in the placebo group ( mean difference , 0.08 mg/dL [ 95 % CI , 0.01 to 0.15 mg/dL ] ; P = .007 ) . Among patients already taking a statin ( n = 416 ) , AKI occurred in 42 of 206 ( 20.4 % ) in the atorvastatin group vs 47 of 210 ( 22.4 % ) in the placebo group ( RR , 0.91 [ 0.63 to 1.32 ] ; P = .63 ) . CONCLUSIONS AND RELEVANCE Among patients undergoing cardiac surgery , high-dose perioperative atorvastatin treatment compared with placebo did not reduce the risk of AKI overall , among patients naive to treatment with statins , or in patients already taking a statin . These results do not support the initiation of statin therapy to prevent AKI following cardiac surgery . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00791648 BACKGROUND Acute kidney injury ( AKI ) is a serious complication of cardiac operations for which there remains no specific therapy . Animal data and several observational studies suggest that statins prevent AKI , but the results are not conclusive , and many studies are retrospective in nature . METHODS We conducted a multicenter prospect i ve cohort study of 625 adult patients undergoing elective cardiac operations . All patients were taking statins and were grouped according to whether statins were continued or held in the 24 hours before operation . The primary outcome was AKI as defined by a doubling of serum creatinine or dialysis . The secondary outcome was the peak level of several kidney injury biomarkers . The results were adjusted for demographic and clinical factors . RESULTS Continuing ( vs holding ) a statin before operation was not associated with a lower risk of AKI , as defined by a doubling of serum creatinine or dialysis ( adjusted relative risk [ RR ] 1.09 ; 95 % confidence interval [ CI ] 0.44 , 2.70 ) . However , continuing a statin was associated with a lower risk of elevation of the following AKI biomarkers : urine interleukin-18 , urine neutrophil gelatinase-associated lipocalin , urine kidney injury molecule-1 , and plasma neutrophil gelatinase-associated lipocalin ( adjusted RR 0.34 ; 95 % CI 0.18 , 0.62 ) , ( adjusted RR 0.41 ; 95 % CI 0.22 , 0.76 ) , ( adjusted RR 0.37 ; 95 % CI 0.20 , 0.76 ) , ( adjusted RR 0.62 ; 95 % CI 0.39 , 0.98 ) , respectively . CONCLUSIONS Statins may prevent kidney injury after cardiac operations , as evidence d by lower levels of kidney injury biomarkers OBJECTIVE Endothelial dysfunction represents a critical early component of organ injury following cardiopulmonary bypass . Recent studies demonstrate that the treatment with atorvastatin is associated with a significant improvement of endothelial function independently of its efficacy on cholesterol levels . Therefore , we investigated the effects of preoperative atorvastatin treatment on endothelium function after coronary surgery . METHODS Forty patients undergoing coronary surgery were r and omized to treatment with atorvastatin ( 20 mg/die ; N=20 ) or placebo ( N=20 ) 3 weeks before surgery . Twenty normal patients served as control group . The flow-mediated dilations ( FMD ) of the brachial artery after both reactive hyperemia ( endothelium dependent ) and nitroglycerin administration ( endothelium independent ) were evaluated at baseline , at 48 h , and 5 days postoperatively . RESULTS At baseline , the endothelium-dependent FMD was significantly attenuated in coronary versus normal patients ( normal 10.3+/-1.8 % vs coronary 4.1+/-1.6 % , p<0.01 ) . At 48 h postoperatively
Output:
| No difference in postoperative atrial fibrillation , myocardial infa rct ion , stroke , infections , or mortality was present .
On sensitivity analysis , statin therapy was associated with a slight increase in hospital mortality .
Meta- analysis including also trials with high or unclear risk of bias showed no beneficial effects of statin therapy on any postoperative outcomes .
Conclusions There is no evidence that statin therapy in the days prior to cardiac surgery is beneficial for patients ’ outcomes .
Particularly , statins are not protective against postoperative atrial fibrillation , myocardial infa rct ion , stroke , or infections .
Statins are associated with a possible increased risk of acute kidney injury and a detrimental effect on hospital survival could not be excluded . |
MS213999 | ***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 comprehend the results of a r and omised controlled trial ( RCT ) , readers must underst and its design , conduct , analysis , and interpretation . That goal can be achieved only through total transparency from authors . Despite several decades of educational efforts , the reporting of RCTs needs improvement . Investigators and editors developed the original CONSORT ( Consoli date d St and ards of Reporting Trials ) statement to help authors improve reporting by use of a checklist and flow diagram . The revised CONSORT statement presented here incorporates new evidence and addresses some criticisms of the original statement . The checklist items pertain to the content of the Title , Abstract , Introduction , Methods , Results , and Discussion . The revised checklist includes 22 items selected because empirical evidence indicates that not reporting this information is associated with biased estimates of treatment effect , or because the information is essential to judge the reliability or relevance of the findings . We intended the flow diagram to depict the passage of participants through an RCT . The revised flow diagram depicts information from four stages of a trial ( enrolment , intervention allocation , follow- up , and analysis ) . The diagram explicitly shows the number of participants , for each intervention group , included in the primary data analysis . Inclusion of these numbers allows the reader to judge whether the authors have done an intention- to-treat analysis . In sum , the CONSORT statement is intended to improve the reporting of an RCT , enabling readers to underst and a trial 's conduct and to assess the validity of its results Reports of cluster r and omised trials require additional information to allow readers to interpret them accurately The effective reporting of r and omised controlled trials has received useful attention in recent years . Many journals now require that reports conform to the guidelines in the Consoli date d St and ards of Reporting Trials ( CONSORT ) statement , first published in 1996 and revised in 2001 . The statement includes a checklist of items that should be included in the trial report . These items are evidence based whenever possible and are regularly review ed . The statement also recommends including a flow diagram to show the flow of participants from group assignment through to the final analysis . The CONSORT statement focused on reporting parallel group r and omised trials in which individual participants are r and omly assigned to study groups . However , in some situations it is preferable to r and omly assign groups of individuals ( such as families or medical practice s ) rather than individuals . Reasons include the threat of contamination of some interventions ( such as dietary interventions ) if individual r and omisation is used . 5 Also , in certain setting s r and omisation by group may be the only feasible method of conducting a trial . Trials with this design are variously known as field trials , community based trials , place based trials , or ( as in this paper ) cluster r and omised trials . In an earlier discussion paper we considered the implication s of the CONSORT statement for the reporting of cluster r and omised trials . Here we present up date d guidance , based on the 2001 revision of the CONSORT statement BACKGROUND Childhood malnutrition is common in Malawi , and the st and ard treatment , which follows international guidelines , results in poor recovery rates . Higher recovery rates have been seen in pilot studies of home-based therapy with ready-to-use therapeutic food ( RUTF ) . OBJECTIVE The objective was to compare the recovery rates among children with moderate and severe wasting , kwashiorkor , or both receiving either home-based therapy with RUTF or st and ard inpatient therapy . DESIGN A controlled , comparative , clinical effectiveness trial was conducted in southern Malawi with 1178 malnourished children . Children were systematic ally allocated to either st and ard therapy ( 186 children ) or home-based therapy with RUTF ( 992 children ) according to a stepped wedge design to control for bias introduced by the season of the year . Recovery , defined as reaching a weight-for-height z score > -2 , and relapse or death were the primary outcomes . The rate of weight gain and the prevalence of fever , cough , and diarrhea were the secondary outcomes . RESULTS Children who received home-based therapy with RUTF were more likely to achieve a weight-for-height z score > -2 than were those who received st and ard therapy ( 79 % compared with 46 % ; P < 0.001 ) and were less likely to relapse or die ( 8.7 % compared with 16.7 % ; P < 0.001 ) . Children who received home-based therapy with RUTF had greater rates of weight gain ( 3.5 compared with 2.0 g . kg(-1 ) . d(-1 ) ; difference : 1.5 ; 95 % CI : 1.0 , 2.0 g . kg(-1 ) . d(-1 ) ) and a lower prevalence of fever , cough , and diarrhea than did children who received st and ard therapy . CONCLUSION Home-based therapy with RUTF is associated with better outcomes for childhood malnutrition than is st and ard therapy Maintaining greater than 95 % adherence to antiretroviral medication is necessary in order to have the greatest therapeutic impact on HIV infection . Furthermore , evidence suggests that adherence rates of between 70 % and 89 % are significantly associated with viral rebound and the development of drug resistance . Adherence rates at and above the 95 % level are difficult for patients to achieve and maintain . Our aim was to determine if an adherence intervention could improve adherence among patients attending an ambulatory care clinic at a large public hospital . The intervention was delivered by a multidisciplinary team of health care professionals and consisted of education coupled with the provision of devices design ed to assist patient memory and adherence . A crucial component of the intervention consisted of the identification of patient specific barriers to adherence and the development of strategies to circumvent these problems . Adherence was assessed using patient self-report over the past 4 , 7 , and 28 days and by calculation of the Morisky score . The study was conducted as a r and omised controlled trial using the stepped wedge design with a total of 68 subjects r and omised to receive the intervention over a 20-week period . Adherence before and after the intervention formed the analysis . There was a significant decrease in the number of missed doses over the past 4 ( 1.9 to 1.0 , p < 0.001 ) , 7 ( 3.0 to 1.8 , p < 0.001 ) and 28 ( 7.4 to 4.2 , p < 0.001 ) days and a decrease in the Morisky score , indicating an improvement in medication taking behaviour ( 1.3 to 0.5 p < 0.001 ) BACKGROUND A r and omized study of the effect on people 's health of improving their housing is underway in Torbay . The link between poor health , particularly respiratory health , and poor housing conditions has been recognized for a long time , but there have been few intervention studies to demonstrate that improving housing can improve health . In 1994 , South and West Devon Health Authority set up a community development project in a deprived area of Torbay , in response to the concerns of local primary health-care workers . A community development worker helped local residents survey their homes for dampness and record their respiratory symptoms . The survey reported high levels of condensation/dampness and respiratory illness and the Council agreed to direct the majority of their housing improvement funds to the estate over the next 3 years . The Health Authority , University of Plymouth and Torbay Council were successful in obtaining funding to evaluate the housing improvements from the NHS R & D programme . PARTICIPANTS AND METHODS Of 119 houses eligible for the study , 50 were chosen at r and om and improved in the first year . The rest were improved the following year . Question naires screening for health problems were sent to all 580 residents and baseline surveys of the indoor environment were also carried out . More detailed health surveys were completed by community nurses visiting residents in their homes . All adults were asked to complete SF-36 and GHQ 12 question naires , as well as disease-specific question naires if appropriate . PROGRESS All houses in the study have now been improved , including insulation , double-glazing , re-roofing , heating , ventilation and electrical rewiring . Follow-up surveys are underway Our aim was to determine if a comprehensive adherence package improved self reported adherence to antiretroviral therapy . The adherence package included an education programme , individualized planning of regimens , and the opportunity for a patient to choose from a number of adherence aids and reminder devices . A r and omized step wedge design was used . Forty-three individuals were r and omized to begin the intervention over a five-month period . There was a substantial fall in the number of missed doses reported for the last four days ( 0.76 to 0.38 , P = 0.03 ) and last seven days ( 1.5 to 0.74 , P = 0.005 ) but not for the last 28 days ( 2.5 to 2.5 , P = 0.63 ) . There was no statistical difference in the viral load or CD4 lymphocyte count in the period before or after the intervention . The Morisky score during the pre and post intervention periods was significantly different ( P = 0.006 ) , 2.9 ( SD 0.9 ) and 3.3 ( SD 0.8 ) respectively . This adherence package improved self reported adherence during the last four and seven days Objective The purpose of the study was to investigate the effects of introducing a critical care outreach service on in-hospital mortality and length of stay in a general acute hospital . Design A pragmatic ward-r and omised trial design was used , with intervention introduced to all wards in sequence . No blinding was possible . Setting Sixteen adult wards in an 800-bed general hospital in the north of Engl and . Patients and participants All admissions to the 16 surgical , medical and elderly care wards during 32-week study period were included ( 7450 patients in total , of whom 2903 were eligible for the primary comparison ) . Interventions Essential elements of the Critical Care Outreach service introduced during the study were a nurse-led team of nurses and doctors experienced in critical care , a 24-h service , emphasis on education , support and practical help for ward staff . Measurements and results The main outcome measures were in-hospital mortality and length of stay . Outreach intervention reduced in-hospital mortality compared with control ( two-level odds ratio : 0.52 ( 95 % CI 0.32–0.85 ) . A possible increased length of stay associated with outreach was not fully supported by confirmatory and sensitivity analyses . Conclusions The study suggests outreach reduces mortality in general hospital wards . It may also increase length of stay , but our findings on this are equivocal
Output:
| Results The 12 studies included in this review describe evaluations of a wide range of interventions , across different diseases in different setting s. However the stepped wedge design appears to have found a niche for evaluating interventions in developing countries , specifically those concerned with HIV . |
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