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MS211400 | ***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 AIM Entecavir is a potent inhibitor of both wild-type and lamivudine-resistant hepatitis B virus ( HBV ) with proven clinical efficacy . We conducted a r and omized , double-blind , multicenter study in Japan ( ETV-052 ) evaluating the efficacy and safety of two doses of entecavir in adult patients with lamivudine-refractory chronic hepatitis B infection . METHODS Eighty-four patients with chronic hepatitis B who were refractory to lamivudine therapy were switched from lamivudine to daily oral doses of 0.5 mg entecavir ( 41 patients ) or 1 mg entecavir ( 43 patients ) for 52 weeks . RESULTS The proportions of patients achieving the primary end-point ( > or=2 log(10 ) reduction in HBV-DNA from baseline by polymerase chain reaction assay or undetectable HBV-DNA levels [ < 400 copies/mL ] at week 48 ) were 90 % and 93 % for entecavir 0.5 mg and 1 mg , respectively , with 33 % of patients in each dosing group achieving < 400 copies/mL. The mean reduction in HBV-DNA from baseline was 3.58 and 3.75 log(10 ) copies/mL for entecavir 0.5 mg and 1 mg , respectively . High proportions of patients achieved alanine aminotransferase normalization at week 48 ( 0.5 mg 86 % , 1 mg 78 % ) . Histological improvement was observed in most patients ( 0.5 mg 52 % , 1 mg 60 % ) . Virological breakthrough ( increase in HBV-DNA of > or=1 log(10 ) copies/mL from nadir ) was observed in one patient but was not associated with selection of entecavir-associated resistance substitutions . Entecavir was well tolerated , with no patients discontinuing study drug due to adverse events . CONCLUSIONS These findings indicate that entecavir is safe and effective for the treatment of Japanese adults with lamivudine-refractory chronic hepatitis BACKGROUND Entecavir is a potent and selective guanosine analogue with significant activity against hepatitis B virus ( HBV ) . METHODS In this phase 3 , double-blind trial , we r and omly assigned 715 patients with hepatitis B e antigen (HBeAg)-positive chronic hepatitis B who had not previously received a nucleoside analogue to receive either 0.5 mg of entecavir or 100 mg of lamivudine once daily for a minimum of 52 weeks . The primary efficacy end point was histologic improvement ( a decrease by at least two points in the Knodell necroinflammatory score , without worsening of fibrosis ) at week 48 . Secondary end points included a reduction in the serum HBV DNA level , HBeAg loss and seroconversion , and normalization of the alanine aminotransferase level . RESULTS Histologic improvement after 48 weeks occurred in 226 of 314 patients in the entecavir group ( 72 percent ) and 195 of 314 patients in the lamivudine group ( 62 percent , P=0.009 ) . More patients in the entecavir group than in the lamivudine group had undetectable serum HBV DNA levels according to a polymerase-chain-reaction assay ( 67 percent vs. 36 percent , P<0.001 ) and normalization of alanine aminotransferase levels ( 68 percent vs. 60 percent , P=0.02 ) . The mean reduction in serum HBV DNA from baseline to week 48 was greater with entecavir than with lamivudine ( 6.9 vs. 5.4 log [ on a base-10 scale ] copies per milliliter , P<0.001 ) . HBeAg seroconversion occurred in 21 percent of entecavir-treated patients and 18 percent of those treated with lamivudine ( P=0.33 ) . No viral resistance to entecavir was detected . Safety was similar in the two groups . CONCLUSIONS Among patients with HBeAg-positive chronic hepatitis B , the rates of histologic , virologic , and biochemical improvement are significantly higher with entecavir than with lamivudine . The safety profile of the two agents is similar , and there is no evidence of viral resistance to entecavir . ( Clinical Trials.gov number , NCT00035633 . ) Background / Aims : The ideal end point of treatment for chronic hepatitis B virus ( HBV ) infection is sustained off-therapy hepatitis B surface antigen ( HBsAg ) loss with or even without seroconversion to anti-HBs . We investigated the role of adding PEGylated interferon ( PEG IFN ) to ongoing tenofovir treatment in chronic HBV patients for achieving HBsAg clearance . Patients and Methods : In this r and omized controlled trial , chronic HBV patients who have been receiving tenofovir for > 6 months with HBV viral load < 2000 IU/ml were r and omized into two groups . One group ( add-on therapy ) was given subcutaneous PEG IFN 180 mcg weekly for 12 months in addition to tenofovir . Patients in the other group received only tenofovir 300 mg orally on a daily basis . Patients in both groups were followed up for a total of two years , and patients in both groups were given tenofovir 300 mg daily indefinitely until they developed HBsAg clearance . Results : Twenty-three patients were allocated to the PEG IFN and tenofovir ( add-on therapy ) group , and another 25 patients were recruited to the tenofovir monotherapy group . Before r and omization , patients had received tenofovir for 1135 mean days ( range203 to 1542 days ) . One patient ( 4.3 % ) in add-on therapy lost HBsAg and seroconverted . Within two years , mean HBsAg decreased significantly with add-on therapy ( from 4753 IU/ml to 2402 ; P= 0.03 ) ; and it decreased from 5957 IU/ml to 4198 ; P= 0.09 in tenofovir monotherapy group . More patients in the add-on group developed serious side effects , with treatment discontinuation , and dose reductions ( P = 0.3 ) . Conclusion : PEG IFN and tenofovir add-on therapy was successful in achieving HBsAg clearance and seroconversion in 4.3 % of the patients . Add-on therapy patients had a significant decrease in HBsAg levels in two years ; and no significant decrease in HBsAg levels with the tenofovir monotherapy . With no significant HBsAg clearance , the utility of this combination regimen is question able Abstract Background Long-term tenofovir disoproxil fumarate ( TDF ) treatment for chronic hepatitis B ( CHB ) is associated with sustained viral suppression and regression of fibrosis and cirrhosis at year 5 ( 240 weeks ) and no TDF resistance through 6 years ( 288 weeks ) . Aim We assessed the efficacy , safety , and resistance of TDF for up to 7 years ( 336 weeks ) in HBeAg-positive and HBeAg-negative CHB patients . Methods Patients who completed 1 year ( 48 weeks ) of r and omized treatment with TDF or adefovir dipivoxil were eligible to receive open-label TDF for a total duration of 8 years ( 384 weeks ) . Results Of 641 patients initially r and omized , 585 ( 91.3 % ) entered the open-label phase ; 437/585 ( 74.7 % ) remained on study at year 7 . For patients on treatment at year 7 , 99.3 % maintained viral suppression ( HBV DNA < 69 IU/mL ) , 80.0 % achieved serum alanine aminotransferase normalization , and in HBeAg-positive patients , 84/154 ( 54.5 % ) and 25/154 ( 11.8 % ) achieved HBeAg and HBsAg loss , respectively . One/375 ( 0.3 % ) HBeAg-negative patients achieved HBsAg loss . No resistance to TDF was detected through 7 years . During the open-label phase , grade 3/4 drug-related adverse events were uncommon ( 1.0 % ) ; ten ( 1.7 % ) patients had elevation of serum creatinine ≥0.5 mg/dL above baseline . No significant change in bone mineral density was observed from year 4 to year 7 ( week 192 to week 336 ) . Conclusions Long-term TDF treatment was associated with sustained virologic , biochemical , and serologic responses , without resistance . TDF treatment was well tolerated , with a low incidence of renal and bone events . These data confirm the safety and efficacy of long-term TDF for CHB BACKGROUND & AIMS We aim ed to compare the viral suppression , safety and rate of drug resistance between besifovir ( a new acyclic nucleotide analogue ) and entecavir . METHODS Treatment-naïve chronic hepatitis B patients receiving besifovir 90 mg ( n=31 ) , 150 mg ( n=28 ) and entecavir 0.5 mg ( n=30 ) were monitored for liver biochemistry , viral serology , HBV DNA levels , development of drug resistance mutations , and adverse events throughout 96 weeks of treatment . RESULTS The mean decline of HBV DNA levels from baseline to week 96 were 5.29 , 5.15 , and 5.67 logs IU/ml for patients receiving besifovir 90 mg , 150 mg and entecavir 0.5 mg , respectively ( p>0.05 ) . Undetectable HBV DNA ( < 20 IU/ml ) were achieved in 80.7 % , 78.6 % , and 80 % ; ALT normalization in 90.3 % , 78.6 % , and 93.3 % ; and loss of HBeAg in 20 % , 21.4 % , and 22.2 % of patients respectively ( all p>0.05 ) . One patient receiving besifovir 90 mg had a virological breakthrough due to drug non-compliance . No patient developed drug resistance mutations . Ten patients had serious adverse events , which were not related to the study medications . The most common side effect related to besifovir was carnitine depletion . Carnitine supplements were prescribed to 83.9 % and 100 % of patients , who had low carnitine level for any one time during follow-up , receiving besifovir 90 mg and 150 mg respectively . No patient had increased creatinine>0.5 mg/dl from baseline . CONCLUSIONS Besifovir had the same antiviral property as compared to entecavir over 96 weeks of treatment for chronic hepatitis B patients . Besifovir was well tolerated and also had a good clinical safety profile BACKGROUND & AIMS Long-term treatment with tenofovir disoproxil fumarate ( TDF ) alone , or in combination with emtricitabine ( FTC ) is associated with sustained viral suppression in patients with lamivudine resistant ( LAM-R ) chronic hepatitis B ( CHB ) . METHODS LAM-R CHB patients were r and omised 1:1 to receive TDF 300 mg or FTC 200 mg and TDF 300 mg once daily in a prospect i ve , double blind , study . The proportion of patients with plasma hepatitis B virus ( HBV ) DNA<69IU/ml ( < 400copies/ml ) at week 96 ( primary efficacy endpoint ) was reported previously . Here we present week 240 follow-up data . RESULTS Overall , 280 patients were r and omised to receive TDF ( n=141 ) or FTC/TDF ( n=139 ) , and 85.4 % completed 240weeks of treatment . At week 240 , 83.0 % of patients in the TDF arm , and 82.7 % of patients in the FTC/TDF treatment arm had HBV DNA<69IU/ml ( p=0.96 ) . Rates of normal alanine aminotransferase ( ALT ) and normalised ALT were similar between groups ( p=0.41 and p=0.97 respectively ) . Hepatitis B e antigen loss and seroconversion at week 240 were similar between groups , ( p=0.41 and p=0.67 respectively ) . Overall , six patients achieved hepatitis B surface antigen ( HBsAg ) loss and one patient ( FTC/TDF arm ) had HBsAg seroconversion by week 240 . No TDF resistance was observed up to week 240 . Treatment was generally well tolerated , and renal events were mild and infrequent ( ∼8.6 % ) . The mean change in bone mineral density at week 240 was -0.98 % and -2.54 % at the spine and hip , respectively . CONCLUSIONS TDF monotherapy was effective and well tolerated in LAM-R CHB patients for up to 240weeks . LAY SUMMARY The goal of oral antiviral treatment for chronic he
Output:
| The most common AEs in all NAs assessed were abdominal pain/discomfort , nasopharyngitis/upper respiratory tract infections , fatigue , and headache .
In conclusion , treatment of CHB with NAs is safe , with a low incidence of AEs .
Despite the general underst and ing TAF being safer than TDF , the number of patients treated with TAF still is too small in comparison to other NAs to consoli date an accurate safety profile . |
MS211401 | ***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 Alzheimer 's disease is characterized by amyloid-beta plaques , neurofibrillary tangles , gliosis , and neuronal loss . Solanezumab , a humanized monoclonal antibody , preferentially binds soluble forms of amyloid and in pre clinical studies promoted its clearance from the brain . METHODS In two phase 3 , double-blind trials ( EXPEDITION 1 and EXPEDITION 2 ) , we r and omly assigned 1012 and 1040 patients , respectively , with mild-to-moderate Alzheimer 's disease to receive placebo or solanezumab ( administered intravenously at a dose of 400 mg ) every 4 weeks for 18 months . The primary outcomes were the changes from baseline to week 80 in scores on the 11-item cognitive subscale of the Alzheimer 's Disease Assessment Scale ( ADAS-cog11 ; range , 0 to 70 , with higher scores indicating greater cognitive impairment ) and the Alzheimer 's Disease Cooperative Study -Activities of Daily Living scale ( ADCS-ADL ; range , 0 to 78 , with lower scores indicating worse functioning ) . After analysis of data from EXPEDITION 1 , the primary outcome for EXPEDITION 2 was revised to the change in scores on the 14-item cognitive subscale of the Alzheimer 's Disease Assessment Scale ( ADAS-cog14 ; range , 0 to 90 , with higher scores indicating greater impairment ) , in patients with mild Alzheimer 's disease . RESULTS Neither study showed significant improvement in the primary outcomes . The modeled difference between groups ( solanezumab group minus placebo group ) in the change from baseline was -0.8 points for the ADAS-cog11 score ( 95 % confidence interval [ CI ] , -2.1 to 0.5 ; P=0.24 ) and -0.4 points for the ADCS-ADL score ( 95 % CI , -2.3 to 1.4 ; P=0.64 ) in EXPEDITION 1 and -1.3 points ( 95 % CI , -2.5 to 0.3 ; P=0.06 ) and 1.6 points ( 95 % CI , -0.2 to 3.3 ; P=0.08 ) , respectively , in EXPEDITION 2 . Between-group differences in the changes in the ADAS-cog14 score were -1.7 points in patients with mild Alzheimer 's disease ( 95 % CI , -3.5 to 0.1 ; P=0.06 ) and -1.5 in patients with moderate Alzheimer 's disease ( 95 % CI , -4.1 to 1.1 ; P=0.26 ) . In the combined safety data set , the incidence of amyloid-related imaging abnormalities with edema or hemorrhage was 0.9 % with solanezumab and 0.4 % with placebo for edema ( P=0.27 ) and 4.9 % and 5.6 % , respectively , for hemorrhage ( P=0.49 ) . CONCLUSIONS Solanezumab , a humanized monoclonal antibody that binds amyloid , failed to improve cognition or functional ability . ( Funded by Eli Lilly ; EXPEDITION 1 and 2 Clinical Trials.gov numbers , NCT00905372 and NCT00904683 . ) There is a great interest in developing cerebrospinal fluid ( CSF ) biomarkers for diagnosis and prognosis of Parkinson 's disease ( PD ) . CSF alpha synuclein ( α-syn ) species , namely total and oligomeric α-syn ( t-α-syn and o-α-syn ) , have shown to be of help for PD diagnosis . Preliminary evidence s show that the combination of CSF t-α-syn and classical Alzheimer 's disease ( AD ) biomarkers — β-amyloid 1–42 ( Aβ42 ) , total tau ( t-tau ) , phosphorylated tau (p-tau)—differentiate PD patients from controls , and that reduced levels of Aβ42 represent a predictive factor for development of cognitive deterioration in PD . In this prospect i ve study carried out in 44 PD patients and 25 neurological controls we wanted to verify whether the combination of CSF α-synuclein species — t-α-syn and o-α-syn— and classical AD biomarkers may help in differentiating PD from neurological controls , and if these biomarkers may predict cognitive decline . The median of follow-up duration was 3 years ( range : 2–6 years ) . Mini Mental State Examination ( MMSE ) and Montreal Cognitive Assessment ( MoCA ) were used for monitoring cognitive changes along time , being administered once a year . Oligo/total α-syn ratio ( o/t-α-syn ratio ) confirmed its diagnostic value , significantly contributing to the discrimination of PD from neurological controls . A greater diagnostic accuracy was reached when combining o/t-α-syn and Aβ42/tau ratios ( Sens = 0.70 , Spec = 0.84 , AUC = 0.82 ; PPV = 0.89 , NPV = 0.62 , LR+ = 4.40 , DOR = 12.52 ) . Low CSF Aβ42 level was associated with a higher rate of MMSE and MoCA decline , confirming its role as independent predictive factor for cognitive decline in PD . None of the other biomarkers assessed ( t-tau , p-tau , t-α-syn and o-α-syn ) showed to have prognostic value . We conclude that combination of CSF o/t-α-syn and Aβ42/tau ratios improve the diagnostic accuracy of PD . PD patients showing low CSF Aβ42 levels at baseline are more prone to develop cognitive decline Neuropsychological ( mostly posterior-cortical ) deficits , quantitative magnetic resonance imaging ( MRI ) atrophy patterns , and low cerebrospinal fluid ( CSF ) levels of amyloid-β have been separately related to worsening cognition in Parkinson 's disease ( PD ) . However , these biomarkers have not been longitudinally assessed in combination as PD-dementia predictors . In this prospect i ve longitudinal study , 27 non-demented PD patients underwent CSF , neuropsychological and 3-T brain-MRI studies at baseline and were re-assessed 18 months later in terms of progression to dementia ( primary outcome ) and longitudinal neuropsychological and cortical thickness changes ( secondary outcomes ) . At follow-up 11 patients ( 41 % ) had progressed to dementia . Lower CSF amyloid-β , worse verbal learning , semantic fluency and visuoperceptual scores , and thinner superior-frontal/anterior cingulate and pre central regions were significant baseline dementia predictors in binary logistic regressions as quantitative and /or dichotomised traits . All participants without baseline biomarker abnormalities remained non-demented whereas all with abnormalities in each biomarker type progressed to dementia , with intermediate risk for those showing abnormalities in a single to two biomarker types ( p = 0.006 ) . Both the dementia- outcome and low baseline CSF amyloid-β were prospect ively associated with limbic and posterior-cortical neuropsychological decline and frontal , limbic and posterior-cortical thinning from baseline to follow-up . These findings suggest that the combination of CSF amyloid-β , neuropsychological and cortical thickness biomarkers might provide a basis for dementia-risk stratification and progression monitoring in PD DATA TOP ( Deprenyl and tocopherol antioxidative therapy of parkinsonism ) is a placebo-controlled clinical trial design ed to test the hypothesis that long-term treatment of patients with early Parkinson 's disease with deprenyl 10 mg/d and /or tocopherol ( vitamin E ) 2000 IU/d will extend the time until disability requires therapy with levodopa ( primary end point ) . At 28 US and Canadian sites , 800 eligible patients in the early stages of untreated Parkinson 's disease were enrolled in DATA TOP and r and omized to ( 1 ) active deprenyl , ( 2 ) active tocopherol , ( 3 ) active deprenyl and tocopherol , or ( 4 ) placebo treatments . Subjects are being evaluated systematic ally at regular intervals over 2 years to determine if and when the primary end point of disability is attained . At baseline evaluation , our cohort represented minimally disabled patients with Parkinson 's disease who did not require symptomatic anti-Parkinson 's disease medications . Despite an almost 2:1 representation of male-female subjects , no selection biases were identified that might confound the primary end-point analysis . This large DATA TOP cohort is expected to provide a high likelihood ( power ) for detecting significant treatment effects , if indeed they exist The prevalence of dementia in Parkinson 's disease ( PD ) is close to 30 % , and its incidence is 4 to 6 times higher than in age-matched general population . PD with dementia ( PDD ) is mainly characterized by a predominant and progressive frontal-subcortical impairment . The Mattis Dementia Rating Scale ( MDRS ) is a commonly used screening test that sensitively measures the degree of frontal-subcortical defects . Although the MDRS has been vali date d as a screening test of cognitive dysfunction in nondemented PD patients ( PD-ND ) , its utility for screening dementia in PD is unknown . In order to vali date the MDRS for diagnosis of PDD it was prospect ively administered to 92 PD patients ( 57 PD-ND , 35 PDD ) fulfilling UK-PDSBB criteria . Dementia was diagnosed according to DSM-IV-TR and a Clinical Dementia Rating ( CDR ) scale score > or=1 . Univariate , logistic regression , and ROC curve analysis were carried out to measure the discriminative power of MDRS in PDD . Regression analysis showed MDRS total scores to independently differentiate PD-ND from PDD ( P < 0.001 ) . Age and education did not predict the presence of dementia . ROC curve analysis showed a cut-off score of < or=123 on the MDRS total scores to yield high sensitivity ( 92.65 % ) , specificity ( 91.4 % ) , positive and negative predictive values ( PPV 83.3 % , NPV 96.4 % ) . A brief version of the MDRS obtained by the addition of the memory , initiation/perseveration , and conceptualization subscores yielded similar discriminant properties . The MDRS has an excellent discriminant ability to diagnose dementia in PD and provides an objective measure to distinguish PD-ND from PDD Objective : To test in vivo the proposal from clinicopathologic studies that β-amyloid ( Aβ ) pathology shortens the time to dementia in Parkinson disease ( PD ) , and to explore the utility of CSF Aβ and related measures as early prognostic biomarkers of dementia in an incident PD cohort . Methods : We assessed a population -based incident cohort of 104 patients with PD who underwent lumbar puncture at diagnosis . We analyzed CSF concentrations of Aβ42 , Aβ40 , and Aβ38 using a multiplexed immunoassay with electrochemiluminescence ( ECL ) detection and levels of Aβ42 , total tau , and phosphorylated tau using ELISA . Patients were followed prospect ively for 5 years . Dementia was diagnosed according to published criteria . Results : CSF levels of Aβ42 were significantly decreased in patients who developed dementia ( n = 20 , 19.2 % ) compared to those who did not ( n = 84 , 80.8 % ) , as measured by ECL ( −33 % , p = 0.006 ) as well as ELISA ( −36 % , p < 0.001 ) . No differences were observed for other markers . Low Aβ42 values predicted a substantially increased risk for subsequent dementia at high sensitivity ( ≥85 % ) , with hazard ratios of 9.9 ( 95 % confidence interval 2.3–43.5 , p = 0.002 ) for Aβ42ECL < 376 pg/mL and 7.6 ( 2.2–26.4 , p = 0.001 ) for Aβ42ELISA < 443 pg/mL , after adjustment for baseline age and PD – mild cognitive impairment ( MCI ) status . Aβ42 reductions tended to precede the onset of PD-MCI that progressed to dementia . Conclusions : These in vivo data support the role of Aβ pathology in the etiology and highlight the potential utility of CSF Aβ42 as an early prognostic biomarker of dementia associated with PD Objective : To investigate whether certain CSF biomarkers at baseline can predict future progression of motor symptoms and cognitive decline in patients with Parkinson disease ( PD ) . Methods : Patients and controls were recruited from hospitals in southern Sweden as part of the prospect i ve and longitudinal Swedish BioFinder Study . In the present study , we included 42 patients with PD and 69 controls who had clinical assessment and lumbar puncture at baseline . Baseline CSF sample s were analyzed for α-synuclein ( αSyn ) , β-amyloid 1–42 ( Aβ42 ) , tau , phosphory
Output:
| Findings from the review suggest a convergence of evidence that a low baseline Aβ42 in the CSF of non-demented PD patients predicts development of cognitive impairment over time .
Conversely , there is limited evidence that CSF levels of tau , either total tau or phosphorylated tau , is a useful predictive biomarker .
There are mixed results for other CSF biomarkers such as α-synuclein , Neurofilament light chain , and Heart fatty acid-binding protein .
Overall the results of this review show that certain CSF biomarkers have better predictive ability to identify PD patients who are at risk for developing cognitive impairment . |
MS211402 | ***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: Asthma self-management programmes have been shown to increase children 's knowledge about asthma and improve their management practice s and health status . However , existing programmes have rarely addressed the unique learning needs of very young children . This study aim ed to develop and assess the effectiveness of a video tape and picture book design ed to teach children about the prevention and management of acute episodes of asthma . The information content of the educational re sources was determined by analysis of relevant medical information and asthma management skills . Social Learning Theory and consideration of the developmental stage of the target population informed the format and style of presentation of the re sources . Eighty children aged between 2 and 5 years who had been diagnosed with asthma by their medical practitioner and who required daily asthma medication participated in a controlled experimental study . The study evaluated the impact of the asthma education re sources on children 's knowledge about asthma , compliance with medication regimens and health status . Children were r and omly allocated to one of three experimental groups . Children in these groups were exposed to either the video tape alone , the book alone or both the video tape and book , or to a control group who viewed material s unrelated to asthma . The results for the three experimental groups were compared with the control group who did not receive exposure to any of the asthma education re sources . The results showed that children in each experimental group had significantly greater gains in asthma-related knowledge than children in the control group and children exposed to both re sources showed the greatest increases in knowledge . Children in each of the three experimental groups also had better compliance and health than children in the control group . These findings indicate that carefully design ed asthma education re sources are useful for providing even the youngest children with information about asthma and its management BACKGROUND Asthma continues to be a substantial cause of morbidity in pediatric population s. New strategies are needed to provide cost-effective educational interventions for children with asthma , particularly those in the inner city . OBJECTIVE To assess the effectiveness of a multimedia educational software program about asthma . SETTING A hospital-based primary care clinic and an affiliated neighborhood health center . DESIGN R and omized , controlled trial . POPULATION Children 3 to 12 years old with physician-diagnosed asthma . INTERVENTION An interactive educational computer program , Asthma Control , design ed to teach children about asthma and its management . Using a graphic display of a child going through simulated daily events , the game emphasizes : 1 ) monitoring ; 2 ) allergen identification ; 3 ) use of medications ; 4 ) use of health services ; and 5 ) maintenance of normal activity . Control group participants review ed printed educational material s with a research assistant . OUTCOMES Acute health care use ( emergency department and outpatient ) was the primary outcome . Secondary outcome measures included maternal report of asthma symptom severity , child functional status and school absences , satisfaction with care , and parental and child knowledge of asthma . RESULTS A total of 137 families were enrolled in the study ( 76 intervention , 61 control ) . Both intervention and control groups showed substantial improvement in all outcomes during the 12-month follow-up period . Aside from improvement in knowledge after use of the computer program , no differences were demonstrated between the 2 groups in primary or secondary outcome measures . Children reported enjoyment of program use . CONCLUSIONS This trial of an educational software program found that it did not produce greater improvement than occurred with review of traditional written material s. Because both groups showed substantial improvement over baseline , computer-based education may be more cost-effective . Alternatively , improvements in illness severity over time may overshadow the effects of such interventions . Rigorous comprehensive evaluations such as this are necessary to assess new interventions intended to improve management and outcomes of asthma Background Childhood obesity has reached epidemic proportions in developed countries . Sedentary screen-based activities such as video gaming are thought to displace active behaviors and are independently associated with obesity . Active video games , where players physically interact with images onscreen , may have utility as a novel intervention to increase physical activity and improve body composition in children . The aim of the Electronic Games to Aid Motivation to Exercise ( eGAME ) study is to determine the effects of an active video game intervention over 6 months on : body mass index ( BMI ) , percent body fat , waist circumference , cardio-respiratory fitness , and physical activity levels in overweight children . Methods / Design Three hundred and thirty participants aged 10–14 years will be r and omized to receive either an active video game up grade package or to a control group ( no intervention ) . Discussion An overview of the eGAME study is presented , providing an example of a large , pragmatic r and omized controlled trial in a community setting . Reflection is offered on key issues encountered during the course of the study . In particular , investigation into the feasibility of the proposed intervention , as well as robust testing of proposed study procedures is a critical step prior to implementation of a large-scale trial . Trial registration Australian New Zeal and Clinical Trials Registry There is a consensus that interventions to prevent and treat childhood obesity should involve the family ; however , the extent of the child 's involvement has received little attention . The goal of the present study was to evaluate the relative efficacy of treating childhood obesity via a family-based health-centred intervention , targeting parents alone v. parents and obese children together . Thirty-two families with obese children of 6 - 11 years of age were r and omised into groups , in which participants were provided for 6 months a comprehensive educational and behavioural programme for a healthy lifestyle . These groups differed in their main agent of change : parents-only v. the parents and the obese child . In both groups , parents were encouraged to foster authoritative parenting styles ( parents are both firm and supportive ; assume a leadership role in the environmental change with appropriate granting of child 's autonomy ) . Only the intervention aim ed at parents-only result ed in a significant reduction in the percentage overweight at the end of the programme ( P=0.02 ) as well as at the 1-year follow-up meeting . The differences between groups at both times were significant ( P<0.05 ) . A greater reduction in food stimuli in the home ( P<0.05 ) was noted in the parents-only group . In both groups , the parents ' weight status did not change . Regression analysis shows that the level of attendance in sessions explained 28 % of the variability in the children 's weight status change , the treatment group explained another 10 % , and the improvement in the obesogenic load explained 11 % of the variability . These results suggest that omitting the obese child from active participation in the health-centred programme may be beneficial for weight loss and for the promotion of a healthy lifestyle among obese children An interactive multimedia computer game to enhance self-management skills and thereby improve asthma outcomes in inner city children with asthma was evaluated . Subjects aged 6 - 17 were recruited from four pediatric practice s and r and omly assigned to the computer intervention condition or to the usual-care comparison . The main character in the game could match the subject on gender and ethnicity . Characteristics of the protagonist 's asthma were tailored to be like those of the subject . Subjects played the computer game as part of regular asthma visits . Time between pre- and post-test varied from 4 to 15.6 months ( mean , 7.6 months ) . Analysis of covariance , with pre-test scores , age , and asthma severity as covariates , found that the intervention was associated with fewer hospitalizations , better symptom scores , increased functional status , greater knowledge of asthma management , and better child self-management behavior for those in the intervention condition . Interactions with covariates were found and discussed in terms of variable efficacy of the intervention Overwhelming evidence shows the quality of reporting of r and omised controlled trials ( RCTs ) is not optimal . Without transparent reporting , readers can not judge the reliability and validity of trial findings nor extract information for systematic review s. Recent method ological analyses indicate that inadequate reporting and design are associated with biased estimates of treatment effects . Such systematic error is seriously damaging to RCTs , which are considered the gold st and ard for evaluating interventions because of their ability to minimise or avoid bias . A group of scientists and editors developed the CONSORT ( Consoli date d St and ards of Reporting Trials ) statement to improve the quality of reporting of RCTs . It was first published in 1996 and up date d in 2001 . The statement consists of a checklist and flow diagram that authors can use for reporting an RCT . Many leading medical journals and major international editorial groups have endorsed the CONSORT statement . The statement facilitates critical appraisal and interpretation of RCTs . During the 2001 CONSORT revision , it became clear that explanation and elaboration of the principles underlying the CONSORT statement would help investigators and others to write or appraise trial reports . A CONSORT explanation and elaboration article was published in 2001 alongside the 2001 version of the CONSORT statement . After an expert meeting in January 2007 , the CONSORT statement has been further revised and is published as the CONSORT 2010 Statement . This up date improves the wording and clarity of the previous checklist and incorporates recommendations related to topics that have only recently received recognition , such as selective outcome reporting bias . This explanatory and elaboration document-intended to enhance the use , underst and ing , and dissemination of the CONSORT statement-has also been extensively revised . It presents the meaning and rationale for each new and up date d checklist item providing examples of good reporting and , where possible , references to relevant empirical studies . Several examples of flow diagrams are included . The CONSORT 2010 Statement , this revised explanatory and elaboration document , and the associated website ( www.consort-statement.org ) should be helpful re sources to improve reporting of r and omised trials BACKGROUND : Interactive Health Communication Applications ( IHCAs ) are computer-based , usually web-based health information packages for patients that combine information with at least one of social support , decision support , or behaviour change support . These are innovations in health care and their effects on health are uncertain . OBJECTIVES : To assess the effects of IHCAs for people with chronic disease . SEARCH STRATEGY : We design ed a four-part search strategy . First , we search ed electronic bibliographic data bases for published work ; second , we search ed the grey literature and third , we search ed for ongoing and recently completed clinical trials in the appropriate data bases . Finally , research ers of included studies were contacted , and reference lists from relevant primary and review articles were followed up . As IHCAs require relatively new technology , the search commenced at 1990 where possible . SELECTION CRITERIA : R and omised controlled trials ( RCTs ) of Interactive Health Communication Applications for adults and children with chronic disease . DATA COLLECTION AND ANALYSIS : One review er screened abstract s. Two review ers screened all c and i date studies to determine eligibility , apply quality criteria , and extract data from included studies . Authors of included RCTs were contacted for missing data . Results of RCTs were pooled using a r and om effects model and st and ardised mean differences ( SMDs ) were calculated to provide net effect sizes . MAIN RESULTS : We screened 24,757 unique citations and retrieved 958 papers for further assessment , yielding 28 RCTs involving 4042 participants . One of these had an inadequate method of concealment of allocation , and sensitivity analyses were performed to determine the effects of including or excluding these data in the meta-analyses . Results in the abstract are from the meta-analyses excluding data from this study .IHCAs were found to have a positive effect on knowledge ( SMD 0.49 ; 95 % confidence interval ( CI ) 0.14 to 0.84 ) and on social support ( SMD 0.47 ; 95 % CI 0.28 to 0.66 ) . IHCAs were found to have no effect on self-efficacy ( SMD 0.15 ; 95 % CI -0.13 to 0.43 ) or behavioural outcomes ( SMD -0.09 ; 95 % CI -0.49 to 0.32 ) . IHCAs had a negative effect on clinical outcomes ( SMD -0.32 ; 95 % CI -0.63 to -0.02 ) . REVIEW ERS ' CONCLUSIONS : The number and range of IHCAs is increasing rapidly ; however there is a shortage of high quality evaluative data . Consumers who wish to increase their knowledge or social support amongst people with a similar problem may find an IHCA helpful . However , consumers whose primary aim is to achieve optimal clinical outcomes should not use an IHCA at present . Further research is needed to determine the reason for this negative effect on clinical outcomes , whether an optimal IHCA can achieve behaviour change and improved health outcomes , and if so , what are the essential features of such an IHCA , and the extent to which they differ according to patient group or condition OBJECTIVE To evaluate Watch , Discover , Think and Act ( WDTA ) , a theory-based application of CD-ROM educational technology for pediatric asthma self-management education . DESIGN A prospect i ve pretest posttest r and omized intervention trial was used to assess the motivational appeal of the computer-assisted instructional program and evaluate the impact of the program in eliciting change in knowledge , self-efficacy , and attributions of children with asthma . Subjects were recruited from large urban asthma clinics , community clinics , and schools . Seventy-six children 9 to 13 years old were recruited for the evaluation . RESULTS Repeated- measures analysis of covariance showed that knowledge scores increased significantly for both groups , but no between-group differences were found ( P : = 0.55 ) ; children using the program scored significantly higher ( P : < 0.01 ) on questions about steps of self-regulation , prevention strategies , and treatment strategies . These children also demonstrated greater self-efficacy ( P : < 0.05 ) and more efficacy building attribution classification of asthma self-management behaviors ( P : < 0.05 ) than those children who did not use the program . CONCLUSION The WDTA is an intrinsically motivating educational program that has the ability to effect determinants of asthma self-management behavior in 9- to 13-year-old children with asthma . This , coupled with
Output:
| In spite of concerns over the quality of some studies and small study population s , MIs were found useful in educating children about their health , and they demonstrated potential to improve children ’s health-related self-efficacy , which could make them more able partners in face-to-face communications with health professionals . |
MS211403 | ***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 Increasing clinical data supports a low α/β ratio for prostate adenocarcinoma , potentially lower than that of surrounding normal tissues . A hypofractionated , weekly radiation therapy ( RT ) schedule should result in improved tumour control , reduced acute toxicity , and similar or decreased late effects . We report the toxicity profile of such treatment . Material s and Methods We conducted a multi-institution phase I/II trial of three-dimensional conformal radiation therapy ( 3D-CRT ) for favourable-risk prostate cancer ( T1a-T2a , Gleason ≤ 6 and PSA < 10 ng/ml ) . RT consisted of 45 Gy in nine 5 Gy fractions , once weekly . Primary end-points were feasibility and late gastrointestinal ( GI ) toxicity ( RTOG scale ) , while secondary end-points included acute GI toxicity , acute and late genitourinary ( GU ) toxicity , biochemical control , and survival . Results Between 2006 and 2008 , 80 patients were treated . No treatment interruptions occurred . The median follow-up is 33 months ( range : 20 - 51 ) . Maximal grade 1 , 2 , and 3 acute ( < 3 months ) GU toxicity was 29 % , 31 % and 5 % respectively ( no grade 4 ) . Acute GI grade 1 toxicity was reported in 30 % while grade 2 occurred in 14 % ( no grade 3 or 4 ) . Crude late grade ≥ 3 toxicity rates at 31 months were 2 % for both GU and GI toxicity . Cumulative late grade ≥ 3 GI toxicity at 3 years was 11 % . Two patients had PSA failure according to the Phoenix definition . The three-year actuarial biochemical control rate is 97 % . Conclusions Weekly RT with 45 Gy in 9 fractions is feasible and results in comparable toxicity . Long term tumour control and survival remain to be assessed BACKGROUND / AIM Based on a radiobiological assumption of a low alpha/beta ( α/β ) ratio for prostate cancer , hypofractionated radiotherapy has increasingly gained traction in the clinical practice and recent guidelines have confirmed the non-inferiority of this approach . Nevertheless , the largest studies that have used hypofractionation so far , employed image-guided radiation therapy/intensity modulated radiation therapy ( IGRT/IMRT ) facilities that might have overcome the radiobiological advantages , which remain to be fully confirmed . The aim of this trial was to evaluate the feasibility of a hypofractionated schedule delivered with 3D-Conformal Radiotherapy to prostate and seminal vesicles in combination with hormonal therapy . PATIENTS AND METHODS The study included 97 consecutive patients with localized prostate cancer ( PCa ) , irrespective of risk class , treated with a schedule of 62 Gy in 20 fractions over 5 weeks ( 4 fractions of 3.1 Gy each per week ) . According to National Comprehensive Cancer Network ( NCCN ) prognostic classification , patients were divided into a favourable group ( 19 % ) , intermediate group ( 41 % ) and unfavourable group ( 40 % ) . Early and late toxicities were scored using the radiation toxicity grading/European Organisation for Research and Treatment of Cancer ( RTOG/EORTC ) criteria . Additionally , the international prostate symptom index ( IPSS ) for benign prostate hypertrophy was used to evaluate obstructive urinary symptoms . Biochemical outcome was reported according to the Phoenix definition for biochemical failure . Hormonal therapy ( HT ) was administrated in 92 % of patients . RESULTS After a median follow-up of 39 months ( range=25 - 52 ) , maximum ≥G2 late genitourinary ( GU ) and gastrointestinal ( GI ) toxicities occurred in 8 % and 11 % patients , respectively . The corresponding figures for acute toxicities were 24 % and 15 % . Patients with higher IPSS score before enrolment had significantly worse urinary function after treatment . Only 2 % of patients died from PCa . Biochemical non- evidence of disease ( bNED ) was 83 % for all patients . CONCLUSION Our study confirms that 3D conformal radiotherapy ( 3DCRT ) remains a safe and effective method to deliver a dose-escalated hypofractionated regimen for PCa patients in all risk classes with acceptable toxicity rates and optimal biochemical control Objective : To report on the design , methodology , and early outcome results of a multi-institutional registry study of prostate cancer radiosurgery . Methods : The Registry for Prostate Cancer Radiosurgery ( RPCR ) was established in 2010 to further evaluate the efficacy and toxicity of prostate radiosurgery ( SBRT ) for the treatment of clinical ly localized prostate cancer . Men with prostate cancer were asked to voluntarily participate in the registry . Demographic , baseline medical , and treatment-related data were collected and stored electronically in a Health Insurance Portability and Accountability Act-compliant data base , maintained by Advertek , Inc. Enrolled men were asked to complete short , multiple choice question naires regarding their bowel , bladder , and sexual function . Patient-reported outcome forms were collected at baseline and at regular intervals ( every 3–6 months ) following treatment . Serial prostate-specific antigen measurements were obtained at each visit and included in the collected data . Results : From July 2010 to July 2013 , nearly 2000 men from 45 participating sites were enrolled in the registry . The majority ( 86 % ) received radiosurgery as monotherapy . At 2 years follow-up , biochemical disease-free survival was 92 % . No Grade 3 late urinary toxicity was reported . One patient developed Grade 3 gastrointestinal toxicity ( rectal bleeding ) . Erectile function was preserved in 80 % of men < 70 years old . Overall compliance with data entry was 64 % . Conclusion : Stereotactic radiosurgery is an alternative option to conventional radiotherapy for the treatment of organ-confined prostate cancer . The RPCR represents the collective experience of multiple institutions , including community-based cancer centers , with outcome results in keeping with published , prospect i ve trials of prostate SBRT Background and purpose For localized prostate cancer , treatment options include external beam radiotherapy ( EBRT ) , radical prostatectomy ( RP ) , and brachytherapy ( BT ) . Erectile dysfunction ( ED ) is a common side-effect . Our aim was to evaluate penile erectile function ( EF ) before and after BT , EBRT , or RP using a vali date d self-administered quality -of-life survey from a prospect i ve registry . Material and methods Analysis included 478 patients undergoing RP ( n = 252 ) , EBRT ( n = 91 ) , and BT ( n = 135 ) with at least 1 year of follow-up and EF documented using IIEF-5 scores at baseline , 6 weeks , 6 months , 1 year , and annually thereafter . Results Differences among treatments were most pronounced among patients with no or mild initial ED ( IIEF-5 ≥ 17 ) . Overall , corrected for baseline EF and age , BT was associated with higher IIEF-5 scores than RP ( + 7.8 IIEF-5 score ) or EBRT ( + 3.1 IIEF-5 score ) . EBRT was associated with better IIEF-5 scores than RP ( + 4.7 IIEF-5 score ) . In patients undergoing EBRT or RP with bilateral nerve sparing ( NS ) , recovery of EF was observed and during follow-up , the differences to BT were not statistically significant . Overall age had a negative impact on EF preservation ( corrected for baseline IIEF ) . Conclusion In our series , EF was adversely affected by each treatment modality . Considered overall , BT provided the best EF preservation in comparison to EBRT or RP.ZusammenfassungHintergrund und ZielDie externe Radiotherapie ( EBRT ) , die radikale Prostatektomie ( RP ) sowie die Brachytherapie ( BT ) stellen Beh and lungsoptionen für das lokalisierte Prostatakarzinom dar . Die erektile Dysfunktion ( ED ) ist eine häufige Nebenwirkung dieser Therapien . Unser Ziel war es , die penile erektile Funktion ( EF ) vor und nach BT , EBRT und RP mit Hilfe eines validierten , vom Patienten ausgefüllten Lebensqualitätsfragebogens aus einer prospektiven Date nbank zu beurteilen . Material und Method enMit einer minimalen Nachbeobachtungszeit von einem Jahr wurden 478 Patienten analysiert , die eine RP ( n = 252 ) , EBRT ( n = 91 ) oder BT ( n = 135 ) erhalten hatten und deren EF mit dem IIEF-5-Score vor Therapie sowie nach 6 Wochen , 6 Monaten , nach einem Jahr und danach jährlich ermittelt worden sind . ErgebnisDie größten therapiebedingten Unterschiede wurden bei Patienten ohne oder nur mit milder initialer ED beobachtet ( IIEF-5 ≥ 17 ) . Korrigiert für die EF und das Alter bei Therapie , war die BT mit höherem IIEF-5-Score assoziiert als die RP ( + 7,8 IIEF-5-Score ) oder die EBRT ( + 3,1 IIEF-5-Score ) . Die EBRT war mit einem besseren IIEF-5-Score assoziiert als die RP ( + 4,7 IIEF-5-Score ) . Bei Patienten mit bilateraler nervenschonender RP oder einer EBRT wurde eine Erholung der EF beobachtet ; i m Verlauf war der Unterschied zur BT nicht mehr statistisch signifikant . Insgesamt hatte ein höheres Alter einen negativen Einfluss auf die Erhaltung der EF ( korrigiert für Ausgangs-EF).SchlussfolgerungIn unserer Serie verschlechterte sich die EF durch alle Therapieformen . Insgesamt bot die BT die beste EF-Erhaltung verglichen mit der EBRT oder RP PURPOSE To compare the toxicity between hypofractionation vs. conventional fractionation schedules in patients with high-risk prostate cancer . METHODS AND MATERIAL S Between January 2003 and December 2007 , 168 patients were r and omized to receive either hypofractionated ( 62 Gy in 20 fractions within 5 weeks , 4 fractions/wk ) or conventionally fractionated ( 80 Gy in 40 fractions within 8 weeks ) three-dimensional conformal radiotherapy to the prostate and seminal vesicles . All patients had undergone a 9-month course of total and rogen deprivation , with radiotherapy starting 2 months after initiation of the total and rogen deprivation . RESULTS The median follow-up was 32 and 35 months in the hypofractionation and conventional fractionation arms , respectively . For the patients developing acute toxicity , no difference between the two fractionation groups was found in either severity or duration of gastrointestinal or genitourinary toxicity . Also , no difference was found in the incidence and severity of late gastrointestinal and genitourinary toxicity between the two treatment schedules , with a 3-year rate of Grade 2 or greater toxicity of 17 % and 16 % for the hypofractionation arm and 14 % and 11 % for the conventional fractionation arm , respectively . A statistically significant correlation between acute and late gastrointestinal toxicity was found only in the conventional fractionation group . CONCLUSION Our findings suggest that the hypofractionation regimen used in our study is safe , with only a slight , nonsignificant increase in tolerable and temporary acute toxicity compared with the conventional fractionation schedule . The severity and frequency of late complications was equivalent between the two treatment groups PURPOSE To compare the toxicity and efficacy of hypofractionated ( 62 Gy/20 fractions/5 weeks , 4 fractions per week ) vs. conventional fractionation radiotherapy ( 80 Gy/40 fractions/8 weeks ) in patients with high-risk prostate cancer . METHODS AND MATERIAL S From January 2003 to December 2007 , 168 patients were r and omized to receive either hypofractionated or conventional fractionated schedules of three-dimensional conformal radiotherapy to the prostate and seminal vesicles . All patients received a 9-month course of total and rogen deprivation ( TAD ) , and radiotherapy started 2 months thereafter . RESULTS The median ( range ) follow-up was 32 ( 8 - 66 ) and 35 ( 7 - 64 ) months in the hypofractionation and conventional fractionation arms , respectively . No difference was found for late toxicity between the two treatment groups , with 3-year Grade 2 rates of 17 % and 16 % for gastrointestinal and 14 % and 11 % for genitourinary in the hypofractionation and conventional fractionation groups , respectively . The 3-year freedom from biochemical failure ( FFBF ) rates were 87 % and 79 % in the hypofractionation and conventional fractionation groups , respectively ( p = 0.035 ) . The 3-year FFBF rates in patients at a very high risk ( i.e. , pretreatment prostate-specific antigen ( iPSA ) > 20 ng/mL , Gleason score > or=8 , or T > or=2c ) , were 88 % and 76 % ( p = 0.014 ) in the former and latter arm , respectively . The multivariate Cox analysis confirmed fractionation , iPSA , and Gleason score as significant prognostic factors . CONCLUSIONS Our findings suggest that late toxicity is equivalent between the two treatment groups and that the hypofractionated schedule used in this trial is superior to the conventional fractionation in terms of FFBF BACKGROUND Studies have reported a low α/β ratio
Output:
| Results Several large-scale trials on moderate hypofractionation with single doses from 2.4–3.4 Gy have recently finished recruiting or have published first results suggestive of equivalent outcomes although there might be a trend for increased short-term and possibly even long-term toxicity . |
MS211404 | ***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 Attention is currently focused on family care of stroke survivors , but the effectiveness of support services is unclear . We did a single-blind , r and omised , controlled trial to assess the impact of family support on stroke patients and their carers . METHODS Patients with acute stroke admitted to hospitals in Oxford , UK , were assigned family support or normal care within 6 weeks of stroke . After 6 months , we assessed , for carers , knowledge about stroke , Frenchay activities index , general health question naire-28 scores , caregiver strain index , Dartmouth co-op charts , short form 36 ( SF-36 ) , and satisfaction scores , and , for patients , knowledge about stroke and use of services , Barthel index , Rivermead mobility index , Frenchay activities index , London h and icap scale , hospital anxiety and depression scales , Dartmouth co-op charts , and satisfaction . FINDINGS 323 patients and 267 carers were followed up . Carers in the intervention group had significantly better Frenchay activities indices ( p=0.03 ) , SF-36 scores ( energy p=0.02 , mental health p=0.004 , pain p=0.03 , physical function p=0.025 , and general health perception p=0.02 ) , quality of life on the Dartmouth co-op chart ( p=0.01 ) , and satisfaction with underst and ing of stroke ( 82 vs 71 % , p=0.04 ) than those in the control group . Patients ' knowledge about stroke , disability , h and icap , quality of life , and satisfaction with services and underst and ing of stroke did not differ between groups . Fewer patients in the intervention group than in the control group saw a physiotherapist after discharge ( 44 vs 56 % , p=0.04 ) , but use of other services was similar . INTERPRETATION Family support significantly increased social activities and improved quality of life for carers , with no significant effects on patients Purpose . We hypothesised that carers of stroke survivors who participate in the Web-based intervention , Caring∼Web © , would have higher well-being than non-Web users . We also postulated that those survivors whose carers participated in Caring∼Web would use fewer healthcare services . Method . A r and omised , two-group , repeated measures design was used . Subjects were recruited from four rehabilitation centres from which first-time stroke survivors were discharged to home in two Midwestern states . Of 144 carers screened , 103 carers of these survivors who were novice Internet users were assigned to a Web or non-Web user group . Seventy-three subjects completed the study . Intervention . Caring∼Web was a Web-based intervention of education and support provided to the Web user group for 1 year . A bi-monthly telephone survey collected data on all carers well-being ( perceived depression , life satisfaction ) and survivors healthcare service use ( self-reported provider and emergency department visits , hospital re-admissions , nursing home placement ) . Results . No statistical differences were found between the groups in carers well-being or in the number of provider visits for survivors . There were significant differences in emergency department visits ( p = 0.001 ) and hospital re-admissions ( p = 0.0005 ) related to the health of survivors . Conclusions . This Web-based intervention helped new carers make informed decisions about healthcare needs of stroke survivors , thus reducing service use Abstract Background Depression occurs in up to 50 % of patients after stroke and limits rehabilitation and recovery . Mood disorders are also highly prevalent in carers ; their mental health intertwined with the physical and mental wellbeing of the person they are caring for . We argue that working with families , rather than patients alone may improve the treatment of depression in both patients and their carers enhancing the mental wellbeing and quality of life of both . Methods A single blind cluster r and omised controlled trial to evaluate whether families after stroke who are treated with the Depression Recognition and Treatment package ( DepReT-Stroke ) in addition to treatment as usual ( TAU ) show improved mental well being compared to those families who receive only TAU . We aim to recruit one hundred and twenty-six families ( 63 in each group ) . The DepReT-Stroke intervention will help families to consider the various treatment options for depression , make choices about which are likely to fit best with their lives and support them in the use of self-help therapies ( e.g. computerised Cognitive Behavioural Therapy or exercise ) . An essential component of the DepReT-Stroke package will be to help people adhere to their chosen treatment(s ) . The primary outcome will be the Mental Component Subscale of the SF-36 assessed at baseline and again six months post intervention . Effectiveness of the intervention will be determined using analysis of co-variance ; comparing the mean change in MCS scores from baseline to six months follow-up adjusting for the clustering effects of baseline scores and family . An economic evaluation of the intervention will help us determine whether the intervention represents a cost-effective use of re sources . Discussion Depression both for patients and their carers is common after stroke . Our Dep ression Re cognition and T reatment package ( DepReT-stroke ) may help clinicians be more effective at detecting and managing a common co-morbidity that limits rehabilitation and recovery . Trial Registration IS RCT N : IS RCT N32451749 Research Ethics Committee Reference Number : 10/H0310/23Grant Reference Number : ( NIHR ) PB-PG-0808 - Background More than 60 % of new strokes each year are " mild " in severity and this proportion is expected to rise in the years to come . Within our current health care system those with " mild " stroke are typically discharged home within days , without further referral to health or rehabilitation services other than advice to see their family physician . Those with mild stroke often have limited access to support from health professionals with stroke-specific knowledge who would typically provide critical information on topics such as secondary stroke prevention , community reintegration , medication counselling and problem solving with regard to specific concerns that arise . Isolation and lack of knowledge may lead to a worsening of health problems including stroke recurrence and unnecessary and costly health care utilization . The purpose of this study is to assess the effectiveness , for individuals who experience a first " mild " stroke , of a sustainable , low cost , multimodal support intervention ( comprising information , education and telephone support ) - " WE CALL " compared to a passive intervention ( providing the name and phone number of a re source person available if they feel the need to ) - " YOU CALL " , on two primary outcomes : unplanned-use of health services for negative events and quality of life . Method / Design We will recruit 384 adults who meet inclusion criteria for a first mild stroke across six Canadian sites . Baseline measures will be taken within the first month after stroke onset . Participants will be stratified according to comorbidity level and r and omised to one of two groups : YOU CALL or WE CALL . Both interventions will be offered over a six months period . Primary outcomes include unplanned use of heath services for negative event ( frequency calendar ) and quality of life ( EQ-5D and Quality of Life Index ) . Secondary outcomes include participation level ( LIFE-H ) , depression ( Beck Depression Inventory II ) and use of health services for health promotion or prevention ( frequency calendar ) . Blind assessors will gather data at mid-intervention , end of intervention and one year follow up . Discussion If effective , this multimodal intervention could be delivered in both urban and rural environments . For example , existing infrastructure such as regional stroke centers and existing secondary stroke prevention clinics , make this intervention , if effective , deliverable and sustainable . Trial Registration IS RCT BACKGROUND national policy recommends routine re- assessment of disabled patients and their carers at 6 months after stroke onset . The clinical and re source outcomes of this policy were investigated . DESIGN prospect i ve , single-blind , r and omised controlled trial in two centres . PARTICIPANTS a total of 265 patients with a disabling stroke and their carers . INTERVENTIONS a structured re- assessment system for patients and their carers at 6 months post-stroke or existing care . OUTCOME MEASURES primary : patient independence ( Frenchay activities index ) and carer stress ( general health question naire 28 ) . Secondary : activities of daily living , mood state , satisfaction with services , carer strain index , health and social service re source use and costs . RESULTS independence at 12 months post-stroke was similar in both groups ( Frenchay activities index , adjusted mean difference 0.64 ; 95 % confidence interval -0.74 - 2.02 ) . Emotional distress in carers was similar in both groups ( general health question naire 28 , mean difference 0.02 ; 95 % confidence interval -0.95 - 1.00 ) . Results for the secondary outcome measures and total mean costs were similar for both groups . The intervention group patients used 301 fewer hospital bed days and 1,631 fewer care home bed days . CONCLUSIONS the structured , systematic re- assessment for patients and their carers was not associated with any clinical ly significant evidence of benefit at 12 months . Health and social care re source use and mean cost per patient were broadly similar in both groups . TRIAL REGISTRATION International St and ard R and omised Controlled Trial Register ; number : IS RCT N55412871 Objective : To investigate an intensified transition concept between neurological inpatient rehabilitation and home care for long-term effects on the care situation two and a half years after stroke patients ' discharge . Design : Controlled clinical trial allocating patients to intervention group ( intensified transition on ward II ) or control group ( st and ard transition on ward I ) ; patients were allocated to whichever ward had a vacancy . The last follow-up assessment was carried out on average 31 months after discharge . Intervention : The intensified transition concept consisted of therapeutic weekend care , bedside teaching and structured information for relatives during the second phase of the rehabilitation . Subjects : Seventy-one patients and their family carers were included , of which one case dropped out . Therefore 70 family carers - 35 individuals in each group - were available for assessment at long-term follow-up . Data collection : Family carers were asked via telephone whether the patient was still alive and if so , where he or she is living - at home or in a nursing home . Statistical methods : Binary logistic regression analysis with the care situation ( home care versus institutionalized care or deceased ) as dependent variable . Results : Two and a half years after discharge ( T3 ) in the intervention group significantly fewer patients were institutionalized ( 2 versus 5 ) or deceased ( 4 versus 11 ) ( P = 0.010 ) . Multivariate analysis showed that besides a higher functional life quality at discharge and lower patient 's age , the participation in the intensified transition programme is the third significant predictor for home care at T3 . Conclusion : Effects of an intensified transition programme can persist over a long-term period . They can sustain home care by reducing institutionalization and mortality Abstract Background Training care givers reduces their burden and improves psychosocial outcomes in care givers and patients at one year . However , the cost effectiveness of this approach has not been investigated . Objective To evaluate the cost effectiveness of caregiver training by examining health and social care costs , informal care costs , and quality adjusted life years in care givers . Design A single , blind , r and omised controlled trial . Setting Stroke rehabilitation unit . Subjects 300 stroke patients and their care givers . Interventions Caregiver training in basic nursing and facilitation of personal care techniques compared with no caregiver training . Main outcome measures Health and social care costs , informal care costs , and quality adjusted life years in care givers over one year after stroke . Results Total health and social care costs over one year for patients whose care givers received training were significantly lower ( mean difference -£4043 ( $ 7249 ; € , 95 % confidence interval -£6544 to -£1595 ) . Inclusion of informal care costs , which were similar between the two groups , did not alter this conclusion . The cost difference was largely due to differences in length of hospital stay . The EQ-5D did not detect changes in quality adjusted life years in care givers . Conclusion Compared with no training , caregiver training during rehabilitation of patients reduced costs of care while improving overall quality of life in care givers at one year Background Stroke is one of the major causes of loss of independence , decreased quality of life and mortality among elderly people . About half of the elderly stroke patients discharged after rehabilitation in a nursing home still experience serious impairments in daily functioning one year post stroke , which can lead to difficulties in picking up and managing their social life . The aim of this study is to evaluate the effectiveness and feasibility of a new multidisciplinary transmural rehabilitation programme for older stroke patients . Methods A two group multicentre r and omised controlled trial is used to evaluate the effects of the rehabilitation programme . The programme consists of three care modules : 1 ) neurorehabilitation treatment for elderly stroke patients ; 2 ) empowerment training for patient and informal caregiver ; and 3 ) stroke education for patient and informal caregiver . The total programme has a duration of between two and six months , depending on the individual problems of the patient and informal caregiver . The control group receives usual care in the nursing home and after discharge . Patients aged 65 years and over are eligible for study participation when they are admitted to a geriatric rehabilitation unit in a nursing home due to a recent stroke and are expected to be able to return to their original home environment after discharge . Data are gathered by face-to-face interviews , self-administered question naires , focus groups and registration forms . Primary outcomes for patients are activity level after stroke , functional dependence , perceived quality of life and social participation . Outcomes for informal caregivers are perceived care burden , objective care burden , quality of life and perceived health . Outcome measures of the process evaluation are implementation fidelity , programme deliverance and the opinion of the stroke professionals , patients and informal caregivers about the programme . Outcome measures of the economic evaluation are the healthcare utilisation
Output:
| Conclusion : There is some limited evidence that interventions for family carers of stroke patients are effective and cost effective .
However , due to variation in the types of interventions examined , little can be concluded regarding implication s for clinical practice |
MS211405 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
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Input: 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 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 The effects of soft laser ( low reactive level laser ) on reduction of pain while undergoing orthodontic treatment was examined in this study . These patients were r and omly separated into 3 groups : non-treated control group ( CG ) , blind irradiation group ( BG ) , and laser irradiated group ( LG ) . The effect of laser irradiation on reduction in pain was analyzed by a question naire given to patients who had been wired with an edgewise appliance of a multi-bracket system for orthodontic therapy . Just after application of the initial wire , LG patients were irradiated with the soft laser from the labial and lingual sites for a total of one minute . Reduction in pain was found in some patients who had been irradiated . In particularly , delay in the pain appearance was noted as compared to the other two control groups
Output:
| We had highlighted in the conclusion that although the heterogeneity and risk of bias of the trial results called for caution , LLLTseemed to be effective in delaying the pain onset , shortening the pain duration , and reducing the average pain intensity . |
MS211406 | ***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 purpose of the present study was to examine the effects of active warm-up duration on the diurnal fluctuations in anaerobic performances . Twelve physical education students performed a medical stress test ( progressive test up to exhaustion ) and four Wingate tests ( measurement of peak power [ Ppeak ] , mean power [ Pmean ] , and fatigue index during an all-out 30 s cycling exercise ) . The tests were performed in separate sessions ( minimum interval = 36 h ) in a balanced and r and omized design at 08:00 and 18:00 h , either after a 5 min ( 5-AWU ) or a 15 min active warm-up ( 15-AWU ) . AWU consisted of pedaling at 50 % of the power output at the last stage of the stress exhausting test . Rectal temperature was collected throughout the sessions . A two-way ANOVA ( warm-up × time of day ) revealed a significant interaction for Ppeak ( F(1.11 ) = 6.48 , p < 0.05 ) and Pmean ( F(1.11 ) = 5.84 , p < 0.05 ) : the time-of-day effect was significant ( p < 0.001 ) in contrast with the effect of warm-up duration ( p > 0.05 ) . Ppeak and Pmean improved significantly from morning to afternoon after both 5-AWU and 15-AWU , but the effect of warm-up duration was significant in the morning only . Indeed , the values of Ppeak or Pmean were the same after both warm-up protocol s in the afternoon . For rectal temperature , there was no interaction between time-of-day and warm-up duration . Rectal temperature before and after both the warm-up protocol s was higher in the afternoon , and the effect of warm-up duration on temperature was similar at 08:00 and 18:00 h. In conclusion , the interpretation of the results of the anaerobic performance tests should take into account time-of-day and warm-up procedures . Longer warm-up protocol s are recommended in the morning to minimize the diurnal fluctuations of anaerobic performances . ( Author correspondence : [email protected] This investigation was conducted to determine the effect of high- and low-intensity warm-ups on physiological responses , lactate accumulation , and high-intensity freestyle and tethered swimming performance . Ten male collegiate swimmers were tested for maximal oxygen uptake ( VO2 max ) followed by two series of three warm-up protocol s performed in a r and omized order at least 2 days apart . The warm-up protocol s were : ( 1 ) no warm-up ( NWU ) , ( 2 ) a 366-m swim at 70 % VO2 max ( LWU ) and ( 3 ) four 46-m swims at 1-min intervals at a speed corresponding to 110 % VO2 max ( HWU ) . Five minutes after each warm-up in the first series , the swimmers swam a 183-m st and ardized freestyle swim at a velocity corresponding to 110 % VO2 max , and 5 min after each warm-up in the second series the swimmers completed a tethered swim to exhaustion with a weight attached to the tether to elicit fatigue at about 2 min . Three minutes after each warm-up and 3 min after each st and ardized and tethered swim , a finger-prick blood sample for lactate measurement was obtained . Heart rate and VO2 were also measured during the warm-up and the st and ardized and tethered swims . The performance times in the tethered swim were not significantly different between the three conditions ( 116.8 + /- 46.8 , 137 + /- 53.3 and 122.94 + /- 37.2 s for the NWU , LWU and HWU , respectively ) . ( ABSTRACT TRUNCATED AT 250 WORDS The purpose of this study was to determine the effect of different static and dynamic stretch protocol s on 20-m sprint performance . The 97 male rugby union players were assigned r and omly to 4 groups : passive static stretch ( PSS ; n = 28 ) , active dynamic stretch ( ADS ; n = 22 ) , active static stretch ( ASST ; n = 24 ) , and static dynamic stretch ( SDS ; n = 23 ) . All groups performed a st and ard 10-minute jog warm-up , followed by two 20-m sprints . The 20-m sprints were then repeated after subjects had performed different stretch protocol s. The PSS and ASST groups had a significant increase in sprint time ( p ≤ 0.05 ) , while the ADS group had a significant decrease in sprint time ( p ≤ 0.05 ) . The decrease in sprint time , observed in the SDS group , was found to be nonsignificant ( p ≥ 0.05 ) . The decrease in performance for the 2 static stretch groups was attributed to an increase in the musculotendinous unit ( MTU ) compliance , leading to a decrease in the MTU ability to store elastic energy in its eccentric phase . The reason why the ADS group improved performance is less clear , but could be linked to the rehearsal of specific movement patterns , which may help increase coordination of subsequent movement . It was concluded that static stretching as part of a warm-up may decrease short sprint performance , whereas active dynamic stretching seems to increase 20-m sprint performance PURPOSE The purpose of the present study was to determine the effect of three different warm-up regimes on cycling work output during a 7-min performance trial . METHODS After habituation to the experimental methods , 12 well-trained cyclists completed a series of 7-min performance trials , involving 2 min of constant-work rate exercise at approximately 90 % VO2max and a further 5 min during which subjects attempted to maximize power output . This trial was performed without prior intervention and 10 min after bouts of moderate , heavy , or sprint exercise in a r and om order . Pulmonary gas exchange was measured breath by breath during all performance trials . RESULTS At the onset of the performance trial , baseline blood [ lactate ] was significantly elevated after heavy and sprint but not moderate exercise ( mean + /- SD : control , 1.0 + /- 0.3 mM ; moderate , 1.0 + /- 0.2 mM ; heavy , 3.0 + /- 1.1 mM ; sprint , 5.9 + /- 1.5 mM ) . All three interventions significantly increased the amplitude of the primary VO2 response ( control , 2.59 + /- 0.28 L x min(-1 ) ; moderate , 2.69 + /- 0.27 L x min(-1 ) ; heavy , 2.78 + /- 0.26 L x min(-1 ) ; sprint , 2.78 + /- 0.30 L x min(-1 ) ) . Mean power output was significantly increased by prior moderate and heavy exercise but not significantly reduced after sprint exercise ( control , 330 + /- 42 W ; moderate , 338 + /- 39 W ; heavy , 339 + /- 42 W ; sprint , 324 + /- 45 W ) . CONCLUSIONS These data indicate that priming exercise performed in the moderate- and heavy-intensity domains can improve severe-intensity cycling performance by ~2 - 3 % , the latter condition doing so despite a mild lactacidosis being present at exercise onset Warm-up and stretching are widely used as techniques in preparation for intense physical activity , yet there is little information available to compare their effectiveness in relation to athletic performance . Fourteen elite Under-19 year old rugby league footballers undertook each of four preparation protocol s ( no preparation , stretching only , warm-up only , warm-up and stretching ) in four successive testing sessions . Protocol s were r and omly allocated to players in a counterbalanced design so that each type of preparation occurred equally on each day of testing . During each session , athletes performed three solo sprint trials at maximum speed . Sprints were of 40-m distance and were electronically timed with wind speed and direction recorded . Preparation involving warm-up result ed in significantly faster sprint times compared to preparations having no warm-up , with a diminishing effect over the three trials . On the first trial , warm-up result ed in a mean advantage of 0.97 m over 40 m. Stretching result ed in a mean disadvantage of 0.18 m on the first trial , and no significant effect overall despite significant wind assistance . Warm-up was effective at improving immediate sprint performance , whereas an equivalent duration of lower limb stretching had no effect Curry , BS , Chengkalath , D , Crouch , GJ , Romance , M , and Manns , PJ . Acute effects of dynamic stretching , static stretching and light aerobic activity on muscular performance in women . J Strength Cond Res 23(6 ) : 1811 - 1819 , 2009-The purpose of this study was to compare three warm-up protocol s-static stretching , dynamic stretching , and light aerobic activity-on selected measures of range of motion and power in untrained females and to investigate the sustained effects at 5 and 30 minutes after warm-up . A total of 24 healthy females ( ages 23 - 29 years ) attended one familiarization session and three test sessions on nonconsecutive days within 2 weeks . A within-subject design protocol with the testing investigators blinded to the subjects ' warm-up was followed . Each session started with 5 minutes of light aerobic cycling followed by pretest baseline measures . Another 5 minutes of light aerobic cycling was completed and followed by one of the three r and omly selected warm-up interventions ( static stretching , dynamic stretching , or light aerobic activity ) . The following posttest outcome measures were collected 5 and 30 minutes following the intervention : modified Thomas test , countermovement jump , and isometric time to peak force knee extension measured by dynamometer . Analysis of the data revealed significant time effects on range of motion and countermovement jump changes . No significant differences ( p > 0.05 ) were found between the warm-up conditions on any of the variables . The variation in responses to warm-up conditions emphasizes the unique nature of individual reactions to different warm-ups ; however , there was a tendency for warm-ups with an active component to have beneficial effects . The data suggests dynamic stretching has greater applicability to enhance performance on power outcomes compared to static stretching Herman , SL and Smith , DT . Four-week dynamic stretching warm-up intervention elicits longer term performance benefits . J Strength Cond Res 22 : 1286 - 1297 , 2008-The purpose of this study was to determine whether a dynamic-stretching warm-up ( DWU ) intervention performed daily over 4 weeks positively influenced power , speed , agility , endurance , flexibility , and strength performance measures in collegiate wrestlers when compared to a static-stretching warm-up ( SWU ) intervention . Twenty-four male National Collegiate Athletic Association Division I wrestlers were r and omly assigned to complete either a 4-week treatment condition ( DWU ) ( n = 11 ) or an active control condition ( SWU ) ( n = 13 ) prior to their daily preseason practice s. Anthropometric and performance measures were conducted before and after the 4-week experimental period ( i.e. , DWU or SWU ) . Measures included peak torque of the quadriceps and hamstrings , medicine ball underh and throw , 300-yd shuttle , pull-ups , push-ups , sit-ups , broad jump , 600-m run , sit- and -reach test , and trunk extension test . Wrestlers completing the 4-week DWU intervention had several performance improvements , including increases in quadriceps peak torque ( 11 % ) , broad jump ( 4 % ) , underh and medicine ball throw ( 4 % ) , sit-ups ( 11 % ) , and push-ups ( 3 % ) . A decrease in the average time to completion of the 300-yd shuttle ( -2 % ) and the 600-m run ( -2.4 % ) was suggestive of enhanced muscular strength , endurance , agility , and anaerobic capacity in the DWU group . In contrast to the DWU intervention , there was no observed improvement in the SWU group for peak torque of the quadriceps , broad jump , 300-yd shuttle run , medicine ball underh and throw for distance , sit-ups , push-ups , or 600-m run , and decrements in some performance measures occurred . The findings suggest that incorporation of this specific 4-week DWU intervention into the daily preseason training regimen of wrestlers produced longer-term or sustained power , strength , muscular endurance , anaerobic capacity , and agility performance enhancements This study aim ed to examine whether athletes are able to self-select their optimal warm up and to propose a method ological approach in investigating the effects of warm up on performance . Nine male subjects underwent a free field warm up ( FWU ) at a self-selected intensity and duration during which heart rate ( HR ) and rectal temperature ( Tre ) were monitored . The intensity of this warm up was subsequently estimated from the HR obtained during an incremental test to determine maximal power ( Pmax ) . Performance ( cycle time to exhaustion at Pmax ) , HR and Tre , were then examined following either : NWU ( no warm up ) ; RWU ( reference warm up based on FWU ) ; RWU-10 ( warm up intensity diminished by 10 % compared to RWU ) ; and RWU+10 ( warm up intensity increased by 10 % compared to RWU ) . Results showed no significant difference in HR ( P = 0.37 ) and Tre increase ( P= 0.77 ) between FWU and RWU . Performance improvement after warm up conditions gave RWU ( 56 % ; ie , 5/9 subjects ) > RWU-10 ( 33 % ; ie , 3/9 ) > RWU+10 ( 11 % ; ie , 1/9 ) > NWU with significant differences between RW
Output:
| Cardiovascular warm-ups increased sprint/running time , but dynamic stretching and dynamic warm-ups had the most positive outcome for the various exercise tests examined .
Systematic ally , static stretching had no beneficial or detrimental effect on exercise performance but did improve range of movement exercises .
CONCLUSIONS Selected warm-up exercise may increase PFT and possibly CFT scores . |
MS211407 | ***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: Recently , there has been interest in whether intakes of specific types of fat are associated with breast cancer risk independently of other types of fat , but results have been inconsistent . We identified 8 prospect i ve studies that met predefined criteria and analyzed their primary data using a st and ardized approach . Holding total energy intake constant , we calculated relative risks for increments of 5 % of energy for each type of fat compared with an equivalent amount of energy from carbohydrates or from other types of fat . We combined study -specific relative risks using a r and om effects model . In the pooled data base , 7,329 incident invasive breast cancer cases occurred among 351,821 women . The pooled relative risks ( 95 % confidence intervals [ CI ] ) for an increment of 5 % of energy were 1.09 ( 1.00 - 1.19 ) for saturated , 0.93 ( 0.84 - 1.03 ) for monounsaturated and 1.05 ( 0.96 - 1.16 ) for polyunsaturated fat compared with equivalent energy intake from carbohydrates . For a 5 % of energy increment , the relative risks were 1.18 ( 95 % CI 0.99 - 1.42 ) for substituting saturated for monounsaturated fat , 0.98 ( 95 % CI 0.85 - 1.12 ) for substituting saturated for polyunsaturated fat and 0.87 ( 95 % CI 0.73 - 1.02 ) for substituting monounsaturated for polyunsaturated fat . No associations were observed for animal or vegetable fat intakes . These associations were not modified by menopausal status . These data are suggestive of only a weak positive association with substitution of saturated fat for carbohydrate consumption ; none of the other types of fat examined was significantly associated with breast cancer risk relative to an equivalent reduction in carbohydrate consumption BACKGROUND We tested the hypothesis that dietary intervention can inhibit the development of recurrent colorectal adenomas , which are precursors of most large-bowel cancers . METHODS We r and omly assigned 2079 men and women who were 35 years of age or older and who had had one or more histologically confirmed colorectal adenomas removed within six months before r and omization to one of two groups : an intervention group given intensive counseling and assigned to follow a diet that was low in fat ( 20 percent of total calories ) and high in fiber ( 18 g of dietary fiber per 1000 kcal ) and fruits and vegetables ( 3.5 servings per 1000 kcal ) , and a control group given a st and ard brochure on healthy eating and assigned to follow their usual diet . Subjects entered the study after undergoing complete colonoscopy and removal of adenomatous polyps ; they remained in the study for approximately four years , undergoing colonoscopy one and four years after r and omization . RESULTS A total of 1905 of the r and omized subjects ( 91.6 percent ) completed the study . Of the 958 subjects in the intervention group and the 947 in the control group who completed the study , 39.7 percent and 39.5 percent , respectively , had at least one recurrent adenoma ; the unadjusted risk ratio was 1.00 ( 95 percent confidence interval , 0.90 to 1.12 ) . Among subjects with recurrent adenomas , the mean ( + /-SE ) number of such lesions was 1.85+/-0.08 in the intervention group and 1.84+/-0.07 in the control group . The rate of recurrence of large adenomas ( with a maximal diameter of at least 1 cm ) and advanced adenomas ( defined as lesions that had a maximal diameter of at least 1 cm or at least 25 percent villous elements or evidence of high- grade dysplasia , including carcinoma ) did not differ significantly between the two groups . CONCLUSIONS Adopting a diet that is low in fat and high in fiber , fruits , and vegetables does not influence the risk of recurrence of colorectal adenomas BACKGROUND Epidemiologic studies have suggested that vitamin E and beta-carotene may each influence the development of prostate cancer . In the Alpha-Tocopherol , Beta-Carotene Cancer Prevention Study , a controlled trial , we studied the effect of alpha-tocopherol ( a form of vitamin E ) and beta-carotene supplementation , separately or together , on prostate cancer in male smokers . METHODS A total of 29133 male smokers aged 50 - 69 years from southwestern Finl and were r and omly assigned to receive alpha-tocopherol ( 50 mg ) , beta-carotene ( 20 mg ) , both agents , or placebo daily for 5 - 8 years ( median , 6.1 years ) . The supplementation effects were estimated by a proportional hazards model , and two-sided P values were calculated . RESULTS We found 246 new cases of and 62 deaths from prostate cancer during the follow-up period . A 32 % decrease ( 95 % confidence interval [ CI ] = -47 % to -12 % ) in the incidence of prostate cancer was observed among the subjects receiving alpha-tocopherol ( n = 14564 ) compared with those not receiving it ( n = 14569 ) . The reduction was evident in clinical prostate cancer but not in latent cancer . Mortality from prostate cancer was 41 % lower ( 95 % CI = -65 % to -1 % ) among men receiving alpha-tocopherol . Among subjects receiving beta-carotene ( n = 14560 ) , prostate cancer incidence was 23 % higher ( 95 % CI = -4%-59 % ) and mortality was 15 % higher ( 95 % CI = -30%-89 % ) compared with those not receiving it ( n = 14573 ) . Neither agent had any effect on the time interval between diagnosis and death . CONCLUSIONS Long-term supplementation with alpha-tocopherol substantially reduced prostate cancer incidence and mortality in male smokers . Other controlled trials are required to confirm the findings The association between vegetable and fruit consumption and stomach cancer risk was investigated in the Netherl and s Cohort Study among 120,852 men and women aged 55 - 69 years at the start in September 1986 . Analyses were based on 282 incident stomach cancer cases after 6.3 years of follow-up . Age- and sex-adjusted rate ratios of stomach cancer in increasing quintiles of combined vegetable and fruit consumption were 1.00 , 0.70 , 0.65 , 0.76 , and 0.64 ( p trend = 0.04 ) . Multivariate analysis result ed in rate ratios that were somewhat closer to one ( p trend = 0.14 ) . Furthermore , inverse associations for total vegetables , pulses , raw leafy vegetables , total fruit , citrus fruit , and apples and pears that were observed in crude analyses became weaker or disappeared in multivariate analyses . Total vegetable , but not fruit , consumption was significantly lower in cases diagnosed in the first follow-up year . In analyses limited to first year cases ( resembling a case-control study ) , rate ratios for increasing tertiles of total vegetable consumption were 1.00 , 0.17 , and 0.18 ( p trend = 0.0001 ) , which may indicate the presence of information bias in case-control studies . This prospect i ve study suggests that vegetable and fruit consumption was not clearly associated with stomach cancer risk in the Dutch population . The findings of this study are comparable with findings of other cohort studies , but they do not support the findings of case-control studies BACKGROUND Previous epidemiologic studies of fruit and vegetable intake and bladder cancer risk have yielded inconsistent results , especially with regard to the types of fruits and vegetables consumed . We examined total fruit and vegetable intake , as well as intakes of subtypes of fruits and vegetables , in relation to bladder cancer risk in a large male prospect i ve cohort study . METHODS Two hundred fifty-two cases of incident bladder cancer were diagnosed from 1986 through January 31 , 1996 , among 47,909 men enrolled in the Health Professionals Follow-up Study . Each participant in this cohort completed a 131-item food-frequency question naire in 1986 and subsequently in 1990 and 1994 . We used logistic regression analyses to examine fruit and vegetable intake in relation to bladder cancer risk , after adjusting for age , history of cigarette smoking , current smoking status , geographic region , total fluid intake , and caloric intake . RESULTS We observed a weak , inverse association that was not statistically significant between total fruit and vegetable intake and bladder cancer risk . Intake of cruciferous vegetables was inversely associated with risk ( relative risk = 0.49 ; 95 % confidence interval = 0.32 - 0.75 , for the highest category of cruciferous vegetable intake compared with the lowest ) , but intakes of yellow or green leafy vegetables or carotenoid-rich vegetables were not associated with risk . Individual cruciferous vegetables , except for coleslaw , were all inversely related to bladder cancer risk , but only the associations for broccoli and cabbage were statistically significant . CONCLUSIONS Data from this study indicate that high cruciferous vegetable consumption may reduce bladder cancer risk , but other vegetables and fruits may not confer appreciable benefits against this cancer BACKGROUND Several recent large prospect i ve cohort studies have failed to demonstrate the presumed protective effect of fruit , vegetable , and dietary fiber consumption on colorectal cancer risk . To further explore this issue , we have examined these associations in a population that consumes relatively low amounts of fruit and vegetables and high amounts of cereals . METHODS We examined data obtained from a food-frequency question naire used in a population -based prospect i ve mammography screening study of women in central Sweden . Women with colorectal cancer diagnosed through December 31 , 1998 , were identified by linkage to regional cancer registries . Cox proportional hazards models were used to estimate relative risks . All statistical tests were two-sided . RESULTS During an average 9.6 years of follow-up of 61 463 women , we observed 460 incident cases of colorectal cancer ( 291 colon cancers , 159 rectal cancers , and 10 cancers at both sites ) . In the entire study population , total fruit and vegetable consumption was inversely associated with colorectal cancer risk . Subanalyses showed that this association was due largely to fruit consumption . The association was stronger , however , and the dose-response effect was more evident among individuals who consumed the lowest amounts of fruit and vegetables . Individuals who consumed less than 1.5 servings of fruit and vegetables per day had a relative risk for developing colorectal cancer of 1.65 ( 95 % confidence interval = 1.23 to 2.20 ; P(trend ) = .001 ) compared with individuals who consumed more than 2.5 servings . We observed no association between colorectal cancer risk and the consumption of cereal fiber , even at amounts substantially greater than previously examined , or of non-cereal fiber . CONCLUSIONS Individuals who consume very low amounts of fruit and vegetables have the greatest risk of colorectal cancer . Relatively high consumption of cereal fiber does not appear to lower the risk of colorectal cancer BACKGROUND Observational studies suggest that people who consume more fruits and vegetables containing beta carotene have somewhat lower risks of cancer and cardiovascular disease , and earlier basic research suggested plausible mechanisms . Because large r and omized trials of long duration were necessary to test this hypothesis directly , we conducted a trial of beta carotene supplementation . METHODS In a r and omized , double-blind , placebo-controlled trial of beta carotene ( 50 mg on alternate days ) , we enrolled 22,071 male physicians , 40 to 84 years of age , in the United States ; 11 percent were current smokers and 39 percent were former smokers at the beginning of the study in 1982 . By December 31 , 1995 , the scheduled end of the study , fewer than 1 percent had been lost to follow-up , and compliance was 78 percent in the group that received beta carotene . RESULTS Among 11,036 physicians r and omly assigned to receive beta carotene and 11,035 assigned to receive placebo , there were virtually no early or late differences in the overall incidence of malignant neoplasms or cardiovascular disease , or in overall mortality . In the beta carotene group , 1273 men had any malignant neoplasm ( except nonmelanoma skin cancer ) , as compared with 1293 in the placebo group ( relative risk , 0.98 ; 95 percent confidence interval , 0.91 to 1.06 ) . There were also no significant differences in the number of cases of lung cancer ( 82 in the beta carotene group vs. 88 in the placebo group ) ; the number of deaths from cancer ( 386 vs. 380 ) , deaths from any cause ( 979 vs. 968 ) , or deaths from cardiovascular disease ( 338 vs. 313 ) ; the number of men with myocardial infa rct ion ( 468 vs. 489 ) ; the number with stroke ( 367 vs. 382 ) ; or the number with any one of the previous three end points ( 967 vs. 972 ) . Among current and former smokers , there were also no significant early or
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| AND RECOMMENDATIONS Overweight/obesity increases the risk for cancers of the oesophagus ( adenocarcinoma ) , colorectum , breast ( postmenopausal ) , endometrium and kidney ; body weight should be maintained in the body mass index range of 18.5 - 25 kg/m(2 ) , and weight gain in adulthood avoided .
Alcohol causes cancers of the oral cavity , pharynx , oesophagus and liver , and a small increase in the risk for breast cancer ; if consumed , alcohol intake should not exceed 2 units/d .
Aflatoxin in foods causes liver cancer , although its importance in the absence of hepatitis virus infections is not clear ; exposure to aflatoxin in foods should be minimised .
Chinese-style salted fish increases the risk for nasopharyngeal cancer , particularly if eaten during childhood , and should be eaten only in moderation .
Fruits and vegetables probably reduce the risk for cancers of the oral cavity , oesophagus , stomach and colorectum , and diets should include at least 400 g/d of total fruits and vegetables .
Preserved meat and red meat probably increase the risk for colorectal cancer ; if eaten , consumption of these foods should be moderate .
Salt preserved foods and high salt intake probably increase the risk for stomach cancer ; overall consumption of salt preserved foods and salt should be moderate .
Very hot drinks and foods probably increase the risk for cancers of the oral cavity , pharynx and oesophagus ; drinks and foods should not be consumed when they are scalding hot . |
MS211408 | ***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: Mendelian r and omization ( MR ) permits causal inference between exposures and a disease . It can be compared with r and omized controlled trials . Whereas in a r and omized controlled trial the r and omization occurs at entry into the trial , in MR the r and omization occurs during gamete formation and conception . Several factors , including time since conception and sampling variation , are relevant to the interpretation of an MR test . Particularly important is consideration of the “ missingness ” of genotypes that can be originated by chance , genotyping errors , or clinical ascertainment . Testing for Hardy-Weinberg equilibrium ( HWE ) is a genetic approach that permits evaluation of missingness . In this paper , the authors demonstrate evidence of nonconformity with HWE in real data . They also perform simulations to characterize the sensitivity of HWE tests to missingness . Unresolved missingness could lead to a false rejection of causality in an MR investigation of trait-disease association . These results indicate that large-scale studies , very high quality genotyping data , and detailed knowledge of the life-course genetics of the alleles/genotypes studied will largely mitigate this risk . The authors also present a Web program ( http://www.oege.org/software/hwe-mr-calc.shtml ) for estimating possible missingness and an approach to evaluating missingness under different genetic models OBJECTIVE Inflammation-induced articular cartilage degradation is a major problem in rheumatoid arthritis ( RA ) . Type 1 T cell activity ( characterized by interferon-gamma/interleukin-2 [ IL-2 ] production ) , and consequently , the production of the proinflammatory cytokines IL-1 and tumor necrosis factor alpha ( TNF alpha ) , have been reported to play a major role in cartilage damage . IL-10 and IL-4 , both produced by type 2 T cells , are cytokines with the capacity to down-regulate proinflammatory responses . The present study was undertaken to investigate the way in which these cytokines affect activated mononuclear cells ( MNC ) of RA patients in relation to human articular cartilage degradation in vitro . METHODS MNC from synovial fluid and peripheral blood of RA patients were stimulated with bacterial antigen and treated with IL-10 and /or IL-4 . Bacterial antigen is known to activate type 1 T cells and to induce proinflammatory IL-1/TNF alpha-dependent cartilage damage . Cytokine production and effects of conditioned media , as well as effects of IL-10 and IL-4 on proteoglycan ( PG ) turnover ( as a measure for cartilage damage ) , were determined . RESULTS IL-10 and IL-4 inhibited proinflammatory cytokine production of stimulated RA MNC and completely reversed inhibition of cartilage PG synthesis induced by these stimulated RA MNC . IL-10 was more potent than IL-4 in this respect , and the combination of IL-10 and IL-4 had an additive effect . In addition , IL-10 directly stimulated cartilage PG synthesis . CONCLUSION IL-10 reverses the cartilage degradation induced by antigen-stimulated MNC , and IL-4 has an additive effect on this process . Furthermore , IL-10 has a direct stimulatory effect on PG synthesis , and IL-4 , as a growth factor for type 2 T cells , can reduce the ratio of type 1 to type 2 T cell activity . These results provide evidence in favor of the use of a combination of the two cytokines in the treatment of RA
Output:
| Conclusions These results suggest that the IL-10 - 1082 G/A polymorphism confers susceptibility to JIA |
MS211409 | ***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 Amplification of the human epidermal growth factor receptor type 2 ( HER2 , also called HER2/neu ) gene and overexpression of its product in breast-cancer cells may be associated with responsiveness to anthracycline-containing chemotherapy regimens . METHODS In the r and omized , controlled Mammary.5 trial , we studied 639 formalin-fixed paraffin-embedded specimens obtained from 710 premenopausal women with node-positive breast cancer who had received either cyclophosphamide , epirubicin , and fluorouracil ( CEF ) or cyclophosphamide , methotrexate , and fluorouracil ( CMF ) as adjuvant chemotherapy . HER2 amplification or overexpression was evaluated with the use of fluorescence in situ hybridization , immunohistochemical analysis , and polymerase-chain-reaction analysis . RESULTS Amplification of HER2 was associated with a poor prognosis regardless of the type of treatment . In patients whose tumors showed amplification of HER2 , CEF was superior to CMF when assessed on the basis of relapse-free survival ( hazard ratio , 0.52 ; 95 percent confidence interval , 0.34 to 0.80 ; P=0.003 ) and overall survival ( hazard ratio , 0.65 ; 95 percent confidence interval , 0.42 to 1.02 ; P=0.06 ) . For women whose tumors lacked amplification of HER2 , CEF did not improve relapse-free survival ( hazard ratio for relapse , 0.91 ; 95 percent confidence interval , 0.71 to 1.18 ; P=0.49 ) or overall survival ( hazard ratio for death , 1.06 ; 95 percent confidence interval , 0.83 to 1.44 ; P=0.68 ) . The adjusted hazard ratio for the interaction between treatment and HER2 amplification was 1.96 for relapse-free survival ( 95 percent confidence interval , 1.15 to 3.36 ; P=0.01 ) and 2.04 for overall survival ( 95 percent confidence interval , 1.14 to 3.65 ; P=0.02 ) . CONCLUSIONS Amplification of HER2 in breast-cancer cells is associated with clinical responsiveness to anthracycline-containing chemotherapy . ( cancer.gov number , NCI-V90 - 0027 . ) Purpose : To critically assess the accuracy and reproducibility of human epidermal growth factor receptor type 2 ( HER-2 ) testing in outside/local community-based hospitals versus two central ized reference laboratories and its effect on selection of women for trastuzumab (Herceptin)–based clinical trials . Experimental Design : Breast cancer specimens from 2,600 women were prospect ively evaluated by fluorescence in situ hybridization ( FISH ) for entry into Breast Cancer International Research Group ( BCIRG ) clinical trials for HER-2-directed therapies . Results : HER-2 gene amplification by FISH was observed in 657 of the 2,502 ( 26 % ) breast cancers successfully analyzed . Among 2,243 breast cancers with central laboratory immunohistochemistry ( 10H8-IHC ) analysis , 504 ( 22.54 % ) showed overexpression ( 2 + or 3 + ) . Outside/local laboratories assessed HER-2 status by immunohistochemistry in 1,536 of these cases and by FISH in 131 cases . Overall , the HER-2 alteration status determined by outside/local immunohistochemistry showed a 79 % agreement rate [ κ statistic , 0.56 ; 95 % confidence interval ( 95 % CI ) , 0.52 - 0.60 ] , with FISH done by the central laboratories . The agreement rate comparing BCIRG central laboratory 10H8-IHC and outside/local laboratory immunohistochemistry was 77.5 % ( κ statistic , 0.51 ; 95 % CI , 0.46 - 0.55 ) . Finally , HER-2 status , determined by unspecified FISH assay methods at outside/local laboratories , showed a 92 % agreement rate ( κ statistic , 0.83 ; 95 % CI , 0.73 - 0.93 ) , with FISH done at the BCIRG central laboratories . Conclusions : Compared with the HER-2 status determined at central ized BCIRG reference laboratories , these results indicate superiority of FISH to accurately and reproducibly assess tumors for the HER-2 alteration at outside/local laboratories for entry to clinical trials BACKGROUND We present the combined results of two trials that compared adjuvant chemotherapy with or without concurrent trastuzumab in women with surgically removed HER2-positive breast cancer . METHODS The National Surgical Adjuvant Breast and Bowel Project trial B-31 compared doxorubicin and cyclophosphamide followed by paclitaxel every 3 weeks ( group 1 ) with the same regimen plus 52 weeks of trastuzumab beginning with the first dose of paclitaxel ( group 2 ) . The North Central Cancer Treatment Group trial N9831 compared three regimens : doxorubicin and cyclophosphamide followed by weekly paclitaxel ( group A ) , the same regimen followed by 52 weeks of trastuzumab after paclitaxel ( group B ) , and the same regimen plus 52 weeks of trastuzumab initiated concomitantly with paclitaxel ( group C ) . The studies were amended to include a joint analysis comparing groups 1 and A ( the control group ) with groups 2 and C ( the trastuzumab group ) . Group B was excluded because trastuzumab was not given concurrently with paclitaxel . RESULTS By March 15 , 2005 , 394 events ( recurrent , second primary cancer , or death before recurrence ) had been reported , triggering the first scheduled interim analysis . Of these , 133 were in the trastuzumab group and 261 in the control group ( hazard ratio , 0.48 ; P<0.0001 ) . This result crossed the early stopping boundary . The absolute difference in disease-free survival between the trastuzumab group and the control group was 12 percent at three years . Trastuzumab therapy was associated with a 33 percent reduction in the risk of death ( P=0.015 ) . The three-year cumulative incidence of class III or IV congestive heart failure or death from cardiac causes in the trastuzumab group was 4.1 percent in trial B-31 and 2.9 percent in trial N9831 . CONCLUSIONS Trastuzumab combined with paclitaxel after doxorubicin and cyclophosphamide improves outcomes among women with surgically removed HER2-positive breast cancer . ( Clinical Trials.gov numbers , NCT00004067 and NCT00005970 . BACKGROUND Women with HER2-overexpressing breast cancer have an unfavorable prognosis . Trastuzumab improves survival when combined with chemotherapy in the first-line treatment of patients with HER2-overexpressing metastatic breast cancer and decreases the rate of disease relapse by 52 % and the rate of death by 33 % in women with HER2-overexpressing early-stage breast cancer . HER2 testing can be performed using immunohistochemistry ( IHC ) or fluorescence in situ hybridization ( FISH ) and can be performed at local pathology laboratories or at central /reference laboratories . Because of the significant benefit seen with trastuzumab , it is critical to accurately identify women most likely to benefit . The method and the location of HER2 testing contribute to the accuracy of test results . PATIENTS AND METHODS HER-First , a prospect i ve , community-based , phase IV study of first-line trastuzumab/taxane therapy , enrolled patients with HER2-overexpressing metastatic breast cancer . Retesting of all tumor specimens by HER2 IHC and FISH at a high-volume , experienced laboratory was required . RESULTS Concordance between local and central laboratory HER2 IHC testing was highest for local IHC 3 + sample s ( n = 377 ; 77 % ) and lowest for IHC 2 + sample s ( n = 184 ; 26 % ) . Thirty-three percent of sample s testing IHC 2 + at a local laboratory tested FISH-positive at the central laboratory . Concordance between HER2 IHC and FISH results was higher when both tests were performed at the central laboratory . CONCLUSION Accurate HER2 test results are critical to identify patients who are appropriate c and i date s for trastuzumab , a therapy with significant clinical benefits in HER2-overexpressing breast cancer . These data show that HER2 testing is most accurate when performed at a high-volume reference laboratory BACKGROUND We have previously reported that high expression of the erbB-2 gene ( also known as HER-2/neu and ERBB2 ) in breast cancer is associated with patient response to dose-intensive treatment with cyclophosphamide , doxorubicin ( Adriamycin ) , and 5-flurouracil ( CAF ) on the basis of short-term follow-up of 397 patients ( set A ) with axillary lymph node-positive tumors who were enrolled in Cancer and Leukemia Group B ( CALGB ) protocol 8541 . METHODS To vali date those findings , we conducted immunohistochemical analyses of erbB-2 and p53 protein expression in an additional cohort of 595 patients ( set B ) from CALGB 8541 , as well as a molecular analysis of erbB-2 gene amplification in tumors from all patients ( sets A and B ) . Marker data were compared with clinical , histologic , treatment , and outcome data . RESULTS Up date d analyses of data from set A ( median follow-up , 10.4 years ) showed an even stronger interaction between erbB-2 expression and CAF dose , by use of either immunohistochemical or molecular data . A similar interaction between erbB-2 expression and CAF dose was observed in all 992 patients , analyzed as a single group . However , for set B alone ( median follow-up , 8.2 years ) , results varied with the method of statistical analysis . By use of a proportional hazards model , the erbB-2 expression-CAF dose interaction was not significant for all patients . However , in the subgroups of patients r and omly assigned to the high- or the moderate-dose arms , significance was achieved . When patient data were adjusted for differences by use of a prognostic index ( to balance an apparent failure of r and omization in the low-dose arm ) , the erbB-2 expression-CAF dose interaction was significant in all patients from the validation set B as well . An interaction was also observed between p53 immunopositivity and CAF dose . CONCLUSIONS The hypothesis that patients whose breast tumors exhibit high erbB-2 expression benefit from dose-intensive CAF should be further vali date d before clinical implementation . Interactions between erbB-2 expression , p53 expression , and CAF dose underscore the complexities of predictive markers where multiple interactions may confound the outcome PURPOSE There is considerable interest in biologic markers able to predict the response of cancer patients to therapy . HER2 overexpression is a potential indicator of responsiveness to doxorubicin and paclitaxel and of unresponsiveness to tamoxifen in breast carcinoma patients . However , the significance of HER2 overexpression in responsiveness to cyclophosphamide , methotrexate , and fluorouracil ( CMF ) has remained unclear . In this study , we investigated this issue in the 386 breast cancer patients in the first CMF controlled clinical trial with a 20-year follow-up . PATIENTS AND METHODS Node-positive breast carcinoma patients were r and omly assigned to receive either no further treatment after radical mastectomy ( 179 women ) or 12 monthly cycles of adjuvant CMF chemotherapy ( 207 women ) . Overexpression of HER2 and the status of other tumor variables was assessed by immunohistochemistry in at least 324 ( 84 % ) of the 386 patients . Statistical analyses were performed to assess the efficacy of CMF treatment for the subgroups defined by HER2 and the status of other variables using a Bayesian approach . The end points considered were relapse-free survival ( RFS ) and cause-specific survival ( CSS ) . RESULTS Bayesian analysis of the treatment effect for HER2 and other variables indicated a clinical benefit from CMF treatment in all subgroups defined according to variables status . In particular regarding HER2 status , Bayesian estimates of RFS hazard ratios were equal to 0.484 and 0.641 and estimates of CSS hazard ratios were equal to 0.495 and 0.730 for HER2-positive and -negative tumors , respectively . CONCLUSION CMF treatment showed a clinical benefit in the considered subgroups , defined according to HER2 and other tumor variables status . Patients with HER2-positive or HER2-negative tumors benefit from CMF treatment , and the poor prognosis associated with the HER2 overexpression in the untreated group could be completely overcome by the chemotherapy treatment 510 Background : CALGB 9344 showed 4 cycles of paclitaxel ( T ) after 4 cycles of doxorubicin/cyclophosphamide ( AC ) improved disease-free ( DFS )
Output:
| When carefully vali date d testing is performed , available data do not clearly demonstrate the superiority of either immunohistochemistry ( IHC ) or in situ hybridization ( ISH ) as a predictor of benefit from anti-HER2 therapy . |
MS211410 | ***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 use of a gonodotropin-releasing hormone ( Gn-RH ) agonist in an in vitro fertilization ( IVF ) program raises the question of any influence on the physical , neurologic , and mental development of the children . We compared the development of children born after long-acting Gn-RH agonist treatment with that of children born after spontaneous pregnancies . Children from singleton pregnancies and > or = 28 months of age were examined by a pediatric neurologist and a psychologist who did not know to which group the children belonged . The General Cognitive Index test was used . Each group included 30 children . Five children cooperated only partly . Physical and neurologic findings were normal in all children , except that one in the group born after in vitro fertilization had diffuse hypotonia , attention-deficit hyperactivity disorder , and hyperactivity . The General Cognitive Index for the 26 children in the study group and the 29 children in the control group who fully cooperated were 102 + /- 13.3 and 106 + /- 13.5 , respectively ( p = 0.37 ) . The verbal perception , motor , and memory indexes were not significantly different . We conclude that the long-acting Gn-RH agonist had no clinical ly identifiable influence on the development of these children OBJECTIVE To determine the growth and physical outcome at 2 years of age for children born after assisted reproductive techniques in the state of Victoria . DESIGN Using a case-matched control study between January 1991 and July 1993 , 314 children ( 196 singletons , 47 sets of twins , 8 sets of triplets ) conceived after in vitro fertilization ( IVF ) and related techniques at the Monash IVF and Royal Women 's Hospital Reproductive Biology Unit and 150 control children ( 113 singletons , 17 sets of twins , 1 set of triplets ) r and omly selected from the general population using the Victorian Perinatal Data Collection Unit records were enrolled to be examined for minor dysmorphic and major organ abnormalities . Singleton and twin cases were matched for plurality and gestation and date of birth . Triplets were not matched . RESULTS IVF status was not a significant independent factor for physical outcomes , including malformation rates , nor for days of hospitalization postdischarge and operations . There was no significant interaction between IVF status and mean percentiles for weight and head circumference . The IVF group had a greater mean length percentile . Twins in both groups had significantly poorer physical outcomes than singletons on some measures . CONCLUSION This study did not demonstrate an independent IVF effect on the growth and physical outcome of children at 2 years of age when matched for plurality and gestation . The poor outcomes where noted were related to the effects of multiple births . These findings must be viewed in context of the response rates and therefore representativeness of the data . The need for longitudinal studies is demonstrated OBJECTIVE To measure the use of infertility treatments in the general population and their association with neonatal health . DESIGN Cross-sectional , population -based study . SETTING Canton of Vaud , Switzerl and ; Etude du Developpement des Nouveau-nés ( EDEN ) , a prospect i ve study of chronic childhood conditions . PATIENT(S ) Six thous and four hundred seventy-seven live newborns ( 6,379 pregnancies ) delivered of residents of Vaud in the 19 maternity hospitals between 1993 and 1994 . MAIN OUTCOME MEASURE(S ) Neonatal morbidity , multiplicity , low birth weight , prematurity , intrauterine growth retardation , transfer to intensive care , and length of hospital stay . RESULT ( S ) Infertility treatments were reported for 2.1 % of pregnancies ( 129 women , 148 newborns ) and were associated significantly with adverse outcomes . Population -attributable risks varied from 3%-20 % . The outcomes of twins did not differ regardless of whether their mother was treated for infertility . Among singletons , only low birth weight was significantly more frequent when infertility treatments were used . Unadjusted odds ratios for neonatal morbidity were significant only for multiple births ( 2.56 ; 95 % confidence interval 1.21 - 5.42 ) . This association was not influenced by maternal characteristics and it disappeared after controlling for sex , gestational age , and birth weight . CONCLUSIONS ( S ) An independent effect of infertility treatments on neonatal morbidity can not be ruled out , but most of their impact appeared to be mediated by multiplicity and prematurity . Reducing the number of medically induced multiple pregnancies is the most effective prevention of neonatal morbidity related to infertility treatments . Follow-up studies are needed OBJECTIVE To describe the characteristics of pregnancies and children at birth result ing from IVF-ET and to assess whether they differ from those after natural conception . DESIGN Prospect i ve multicenter survey . SETTING A national registry , representing 80 % of all French IVF-ET activity for the period 1986 to 1990 . PATIENTS Data on 7,024 pregnancies , 5,371 deliveries , and 6,879 newborn infants . INTERVENTIONS A form is completed for every clinical pregnancy . MAIN OUTCOME MEASURES Spontaneous abortion , ectopic pregnancy , multiple pregnancy , prematurity , hypotrophy , perinatal and neonatal mortality , and congenital malformations rates . RESULTS The spontaneous abortion and ectopic pregnancy rates were , respectively , 17.6 % and 5.8 % . More than a quarter ( 26.8 % ) of the deliveries were multiple births . The preterm birth rate ( 29.3 % ) , the low birth weight rate ( 36.2 % ) , and the perinatal and neonatal mortality rates were higher than the national average . The rate of malformations ( 2.8 % ) was comparable with the general population ( 2.1 % ) . CONCLUSION Assisted conception frequently results in multiple pregnancy , and this is the main determinant of pregnancy outcome . Nevertheless , it is not the only risk factor for prematurity , which is also more frequent among IVF singleton newborn . The prevalence of congenital malformations is not higher than after natural conception There is an ongoing discussion regarding conflicting data on malformation rate in children born after intracytoplasmic sperm injection ( ICSI ) . A prospect i ve , multicentric , control cohort study was done in Germany . Fifty-nine centres prospect ively recruited pregnancies before the 16th week of gestation , which were included in the study if they were ongoing beyond this time . Children were examined according to a st and ardized procedure . A control cohort of children conceived spontaneously was taken from a prospect i ve birth registry ( Mainzer Modell ) , where children were examined according to the exact same criteria as the ICSI cohort . Major malformation rate was calculated , based on data of all liveborn and stillborn children , as well as on all spontaneous and induced abortions , beginning with the 16th week of gestation . In the ICSI cohort , 8.6 % of infants ( 291/3372 ) , and in the control cohort 6.9 % of infants ( 2140/30940 ) , had a major malformation . This result ed in a crude relative risk ( RR ) of 1.25 ( 95 % confidence interval 1.11 - 1.40 ) . There was no influence of sperm origin on major malformation rate in children born after ICSI . There is an increased risk for a child born after ICSI to have a major malformation compared with a child that has been spontaneously conceived . Based on knowledge of the early developmental steps following ICSI , as well as on data of conventional IVF in general , it is assumed that this increased risk is due to parental factors causing the infertility , which has led to ICSI in the first place A prospect i ve series of 90 consecutive pregnancies ( 70 singleton , 16 twin and 4 triplet pregnancies ) result ing in births of 114 infants after in vitro fertilisation ( IVF ) at Rigshospitalet were compared to a control group of pregnancies and deliveries in 70 non‐IVF infertility patients with singleton pregnancies and 20 women with normal fertility with twin ( n=16 ) or triplet ( n=4 ) pregnancies . No differences in the incidence of third trimester pregnancy complications , abnormal fetal karyotypes or malformations were found . The number of women with spontaneous onset of labor and the gestational age at delivery were similar in the IVF and control groups . In singleton deliveries , the birth weight was lower ( p<0.025 ) in the IVF group ( median 3145 g , range 8904300 g ) than in the control group ( 3399 g , 2592–4850 g ) , whereas in multiple gestation similar birth weights were found in the IVF and control groups . We conclude that the birth weight in singleton deliveries after IVF is lower than the birth weight in infertility patients treated differently . The cause of this difference remains obscure To assess the physical and mental development of infants born after in vitro fertilization ( IVF ) , we performed a general physical and developmental examination ( Bayley and Stanford-Binet scales ) on a cohort of 116 IVF children , conceived and born at our institution between February 1985 and March 1989 , and on 116 non-IVF matched controls . Study and control groups were each composed of 66 singletons , 19 pairs of twins and 4 sets of triplets , whose age at examination ranged from 12 to 45 months . The developmental indices of IVF infants were within the normal range and did not differ from those of their matched controls . The indices were positively correlated to gestational age , birth weight , head circumference at birth and at examination , and mother 's education . Mean birth weight , gestational age , and birth weight percentile of IVF infants were lower than the mean of the healthy population . Mean percentiles of weight and length at examination ( mean age 22.4 months ) were equally low but did not differ from those of the matched controls . However , mean percentiles of head circumference at birth and at examination compare well with the normal mean , both in IVF and control groups . Twins and triplets ( IVF and controls ) had significantly lower physical and mental indices as compared to singletons Health outcomes during the first year for 95 infants born following in-vitro fertilization ( IVF ) were compared with those of 79 naturally conceived controls whose mothers were of identical parity and similar age . Primigravid women were enrolled prospect ively at 30 weeks gestation , perinatal and neonatal data were collected during pregnancy and following birth , and details of health care re source use were obtained from mothers at 4 and 12 months . Median ( range ) number of medical problems during the first year tended to be less for IVF infants , 4 ( 0 - 41 ) versus 5 ( 0 - 12 ) ( P = 0.07 ) , whilst total number of visits to health care workers was similar for IVF and control infants , 19 ( 2 - 47 ) versus 19 ( 1 - 47 ) . IVF infants were more likely to have an excessive number of visits to Early Childhood Health Care Centres [ odds ratio ( OR ; 95 % confidence interval , CI ) = 2.44 ( 1.11 - 5.56 ) ] , but less likely to have an excessive number of visits to general medical practitioners [ OR = 0.45 ( 0.22 - 0.93 ) ] and other health care workers [ OR = 0.48 ( 0.23 - 0.99 ) ] . These data provide some degree of reassurance about medium-term health outcomes for children conceived using IVF . Although they are more likely to utilize the re sources of neonatal intensive care units , IVF infants do not appear to have an increased number of medical problems or to over-utilize health care re sources during the remainder of their first year of life OBJECTIVE To assess the somatic , psychomotor , and intellectual development of children conceived through intracytoplasmic single sperm injection ( ICSI ) over the whole preschool period . DESIGN Prospect i ve , controlled , cohort study . SETTING Fertility clinic in Brussels , Belgium . PATIENT(S ) Sixty-six ICSI-conceived children prospect ively compared with 52 IVF-conceived and 59 spontaneously conceived children . All children were full-term singletons . INTERVENTION(S ) Home visits by a trained psychologist . St and ardized interviews . Assessment s using the revised Brunet-Lézine scale and the revised Wechsler preschool and primary scale of intelligence . MAIN OUTCOME MEASURE(S ) Physical growth and general health . Formal developmental and intellectual assessment s. RESULT ( S ) Children conceived by ICSI were healthy : no significant differences appeared in the incidence of combined congenital malformations ( 11.3 % ) , health problems ( 44.1 % ) , surgical interventions ( 18.6 % ) , and hospitalizations ( 6.8 % ) , nor for the developmental assessment s ( mean developmental quotient at 9 months : 93.9 ; at 18 months : 102.0 ) . For the intellectual assessment s , the between-group differences disappeared when adjusted for levels of parental education ( mean intelligence quotient at 3 years : 97.0 ; at 5 years : 103.3 ) . CONCLUSION ( S ) This pilot study shows that throughout the preschool period , ICSI-conceived children have psychomotor and intellectual development similar to that of IVF-conceived and spontaneously conceived children . These conclusions need to be confirmed by multicenter studies BACKGROUND Intracytoplasmic sperm injection ( ICSI ) was introduced
Output:
| Pooled results from all suitable published studies suggest that children born following ART are at increased risk of birth defects compared with spontaneous conceptions . |
MS211411 | ***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 eluci date the potential mechanisms involved in the physiopathology of endometriosis . We analyzed the differential gene expression profiles of eutopic and ectopic tissues from women with endometriosis . DESIGN Prospect i ve laboratory study . SETTING University hospital . PATIENT(S ) Seventeen patients in whom endometriosis was diagnosed and 11 healthy fertile women . INTERVENTION(S ) Endometrial biopsy specimens from the endometrium of healthy women without endometriosis and from the eutopic and ectopic endometrium tissues of patients with endometriosis were obtained in the early proliferative phase of the menstrual cycle . MAIN OUTCOME MEASURE(S ) Six paired sample s of eutopic and ectopic tissue were analyzed by subtractive hybridization . To evaluate the expression of genes found by rapid subtraction hybridization methods , we measured CTGF , SPARC , MYC , MMP , and IGFBP1 genes by real-time polymerase chain reaction in all sample s. RESULT ( S ) This study identified 291 deregulated genes in the endometriotic lesions . Significant expression differences were obtained for SPARC , MYC , and IGFBP1 in the peritoneal lesions and for MMP3 in the ovarian endometriomas . Additionally , significant differences were obtained for SPARC and IGFBP1 between the peritoneal and ovarian lesions . No significant differences were found for the studied genes between the control and the eutopic endometrium . CONCLUSION ( S ) This study identified 291 genes with differential expression in endometriotic lesions . The deregulation of the SPARC , MYC , MMP3 , and IGFBPI genes may be responsible for the loss of cellular homeostasis in endometriotic lesions BACKGROUND Little is known about the precise nature of the relationship between dysmenorrhoea ( DM ) and endometriosis . Our aim was to evaluate the relationship between the severity of DM in women with posterior deep infiltrating endometriosis ( DIE ) and indicators of the extent of their disease . METHODS Various indicators of the extent of DIE were recorded during surgery in 209 women . The severity of their DM was assessed with a pain scale . The scale was retrospective for 155 women and prospect i ve for 54 . Correlations were sought with an ordinal logistic regression model with cumulative odds . RESULTS On univariate analysis the following variables were related to the severity of DM : number of previous surgical procedures for endometriosis ; revised American Fertility society classification ; extensiveness of adnexal adhesion ; Douglas obliteration ; size of the posterior DIE implant ; extent of the sub-peritoneal infiltration by the posterior DIE ( rectal , vaginal or both versus sub-peritoneal only ) . Current infertility was associated with less severe DM . After multiple regression analysis , presence of a rectal or vaginal infiltration by the posterior DIE and extensiveness of adnexal adhesion were the only factors that remained related to DM severity . CONCLUSIONS The concept of ' very deep infiltrating endometriosis ' , defined as implants invading the wall of the pelvic organ , should be tested in future classification systems specifically addressed to the prediction of endometriosis-related pain OBJECTIVE To evaluate the expression of biomarkers of implantation , glycodelin A ( GdA ) , osteopontin ( OPN ) , lysophosphatidic acid receptor 3 ( LPA3 ) , and HOXA10 , in eutopic endometrium of women with and without endometriosis . DESIGN Prospect i ve observational study . SETTING Clinical research center . PATIENT(S ) Twenty-four women with endometriosis and 23 healthy volunteers of similar age . INTERVENTION(S ) Secretory phase endometrial biopsy . MAIN OUTCOME MEASURE(S ) Expression of immunohistochemical staining intensity and localization of GdA , OPN , LPA3 , and HOXA10 in eutopic endometrium . RESULT ( S ) Endometrial GdA expression was significantly reduced in patients after cycle day 22 . The endometrium from women with endometriosis also showed decreased expression of OPN in the late secretory phase and LPA3 and HOXA10 expression in the midsecretory and late secretory phases . CONCLUSION ( S ) The decreased expression of these four biomarkers of implantation may indicate impaired endometrial receptivity in patients with endometriosis , providing one explanation for the subfertility observed even in women with few pelvic implants . Because many of these markers are P dependent , these findings suggest the possibility of reduced endometrial P action in this population To determine the value of leukemia inhibitory factor ( LIF ) assessment for predicting the reproductive outcome Purpose To determine if endometrial gene expression is different in women with endometriosis-related infertility and fertile women . Methods Prospect i ve study of mid-follicular phase endometrium in 47 subjects in two phases : microarray study of 10 infertile women with endometriosis and five fertile controls , and a quantitative real-time PCR ( qRT-PCR ) study of 27 infertile women with endometriosis and 15 fertile controls . Gene expression was determined by DNA microarray , and qRT-PCR used for 12 “ promising ” genes based on the microarray analysis . Results Compared to fertile controls , women with stage I – II endometriosis had 23 , and women with stage III – IV had 35 genes that were significantly up- or down-regulated by microarray . However , using qRT-PCR , only chemokine lig and ( CXCL ) 13 was significantly down-regulated and somatostatin was significantly up-regulated with early endometriosis , and only CXCL 14 was significantly down-regulated with advanced endometriosis compared to fertile controls . Conclusions Our findings indicate that the pattern of gene expression in proliferative-phase endometrium is different when comparing tissue from patients with endometriosis versus fertile controls . Recognition of these endometrial alterations could be helpful to diagnose and stage endometriosis , and may provide insight to explain why conception rates are low in women with endometriosis OBJECTIVE To examine the expression of gremlin-1 ( GREM1 ) on the levels of messenger RNA ( mRNA ) and protein in eutopic endometrium and its serum level in patients with endometriosis . DESIGN Prospect i ve , experimental study using reverse-transcription polymerase chain reaction , Western blot , immunofluorescence , and ELISA . SETTING Gynecological oncology laboratory in a department of obstetrics and gynecology in a medical college in China . PATIENT(S ) Thirty-five patients with endometriosis and 23 healthy control women . INTERVENTION(S ) During surgery , the eutopic endometria and peripheral serum were obtained from the patients with endometriosis and the control women . MAIN OUTCOME MEASURE(S ) The cellular compartment location of GREM1 expression was examined by using immunofluorescent double staining . The expression levels of mRNA and protein for GREM1 were determined by reverse-transcription polymerase chain reaction and Western blot , respectively . The serum level of GREM1 was measured by indirect ELISA . RESULT ( S ) The expression of GREM1 was defined within endometrial blood vessel endothelium exclusively , with the concomitant expressions of GREM1 and CD146 . The expression of GREM1 on the levels of mRNA and protein was significantly higher in eutopic endometria of patients with endometriosis than in those from healthy control women . According to the ELISA established in our laboratory , the concentration of GREM1 in peripheral serum that was collected during the follicular menstrual phase of patients with endometriosis was significantly higher than that in serum from healthy control women . CONCLUSION ( S ) Gremlin-1 plays a role to some extent in the aberrant angiogenesis of eutopic endometrium in patients with endometriosis . It is possible that the peripheral serum level of GREM1 is a prospect i ve serum biomarker of endometriosis OBJECTIVE To analyze the expression of the glycodelin gene to better underst and the molecular environment of endometriotic lesions and to eluci date the potential mechanisms that underlie the complex physiopathology of endometriosis . DESIGN Prospect i ve laboratory study . SETTING University hospital . PATIENT(S ) Eleven healthy fertile women and 17 patients with endometriosis in the early proliferative phase of the menstrual cycle . INTERVENTION(S ) Endometrial biopsy specimens were obtained from the endometrium of healthy women without endometriosis ( controls ) and from eutopic and ectopic endometrium tissues ( pelvic and ovarian endometriotic implants ) of endometriosis patients . MAIN OUTCOME MEASURE(S ) The glycodelin relative expression level by real-time polymerase chain reaction ( PCR ) analysis . RESULT ( S ) The glycodelin down-regulation found in the endometriotic lesions was 332.26 and 123.17-fold lower , respectively , when compared with the eutopic tissue and the control endometrium . CONCLUSION ( S ) Glycodelin may be one of the molecules that contributes to the loss of cellular homeostasis in endometriotic lesions OBJECTIVE To develop a clinical tool that predicts pregnancy rates ( PRs ) in patients with surgically documented endometriosis who attempt non-IVF conception . DESIGN Prospect i ve data collection on 579 patients and comprehensive statistical analysis to derive a new staging system -- the endometriosis fertility index (EFI)--from data rather than a priori assumptions , followed by testing the EFI prospect ively on 222 additional patients for correlation of predicted and actual outcomes . SETTING Private reproductive endocrinology practice . PATIENT(S ) A total of 801 consecutively diagnosed and treated infertile patients with endometriosis . INTERVENTION(S ) Surgical diagnosis and treatment followed by non-IVF fertility management . MAIN OUTCOME MEASURE(S ) The EFI and life table PRs . RESULT ( S ) A statistically significant variable used to create the EFI was the least function score ( i.e. , the sum of those scores determined intraoperatively after surgical intervention that describe the function of the tube , fimbria , and ovary on both sides ) . Sensitivity analysis showed that the EFI varies little , even with variation in the assignment of functional scores , and predicted PRs . CONCLUSION ( S ) The EFI is a simple , robust , and vali date d clinical tool that predicts PRs after endometriosis surgical staging . Its use provides reassurance to those patients with good prognoses and avoids wasted time and treatment for those with poor prognoses Background The role of estrogen receptor beta ( ERβ ) in pathogenesis of endometriosis remains to be eluci date d. In this study , we have examined the expression of the four main ERβ transcript isoforms in human endometrial tissue in women with or without endometriosis . Methods Total RNA was isolated from native endometrial tissue and transcript levels of ERα , β1 , β2 , β4 , β5 were analyzed by means of RT-PCR . We compared the results with regard to menstrual cycle phase as well as to presence or absence of endometriosis . We prospect ively harvested the endometrium of ten women without endometriosis ( five for each cycle phase ) and eight patients with endometriosis ( five in the proliferative phase , three in the secretory phase ) . Results ERα , β1 , β2 , and β5 transcripts were detected in both cycle phases . During the proliferative phase , healthy women had a significantly higher ERα/ERβ1-ratio than patients with endometriosis . Irrespective of the cycle phase , ERα-mRNA level was significantly higher than transcript levels of ERβ isoforms . Conclusions ERα , β1 , β2 , and β5 are expressed in human endometrium . The individual receptors differed in terms of expression strength but there was no relevant change during the cycle . The decreased ERα/ERβ1-ratio in proliferative endometrium of endometriosis patients suggest that ERβ1 might be involved in the pathogenesis of endometriosis . Further studies should be undertaken to substantiate the role of ERβ in endometrial pathology BACKGROUND The aim of our study was to test the hypothesis that multiple-sensory small-diameter nerve fibres are present in a higher density in endometrium from patients with endometriosis when compared with women with a normal pelvis , enabling the development of a semi-invasive diagnostic test for minimal-mild endometriosis . METHODS Secretory phase endometrium sample s ( n = 40 ) , obtained from women with laparoscopically/histologically confirmed minimal-mild endometriosis ( n = 20 ) and from women with a normal pelvis ( n = 20 ) were selected from the biobank at the Leuven University Fertility Centre . Immunohistochemistry was performed to localize neural markers for sensory C , Adelta , adrenergic and cholinergic nerve fibres in the functional layer of the endometrium . Sections were immunostained with anti-human protein gene product 9.5 ( PGP9.5 ) , anti-neurofilament protein , anti-substance P ( SP ) , anti-vasoactive intestinal peptide ( VIP ) , anti-neuropeptide Y and anti-calcitonine gene-related polypeptide . Statistical analysis was done using the Mann-Whitney U-test , receiver operator characteristic analysis , stepwise logistic regression and least-squares support vector machines . RESULTS The density of small nerve fibres was approximately 14 times higher in endometrium from patients with minimal-mild end
Output:
| Although PGP 9.5 met the criteria for a replacement test , it demonstrated considerable inter study heterogeneity in diagnostic estimates , the source of which could not be determined .
Several endometrial biomarkers , such as endometrial proteome , 17βHSD2 , IL-1R2 , caldesmon and other neural markers ( VIP , CGRP , SP , NPY and combination of VIP , PGP 9.5 and SP ) showed promising evidence of diagnostic accuracy , but there was insufficient or poor quality evidence for any clinical recommendations .
We have also identified a number of biomarkers that demonstrated no diagnostic value for endometriosis . |
MS211412 | ***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 .We tested the hypothesis that a monitoring display proposed by Blike et al. improves the performance of anesthesiologists . We measured the performance of anesthesiologists using the new display and compared it to their performance with at raditional display . We studied three different displays on how they affected recognition and differentiation of five etiologies ofshock – anaphylaxis , bradycardia , hypovolemia , ischemia and pulmonary embolus . Methods .The participants monitored heartrate , systemic arterial and pulmonary blood pressure , central venous pressure , and cardiac output during five shock states and five non-shock states . The result ing 10 data sets made up ten decision screens , which we presented r and omly on a computer monitor to the subjects in one of three different formats ( a Single Sensor Single Indicator (SSSI)Numericdisplay ; anObjectdisplay ; and an Object Minus Shapesdisplay ) . Subjects used soft-buttons on a computer touch-screen monitor to : a ) advance to the next display ; b ) differentiate a non-shock state from a shock state ; and , c ) select the etiology of shock state represented by the display ( Figure 4 ) . The internal clock and memory of the computer made the collection of data automatic . Results .The subjects recognized a problem more rapidly with the help of a graphical “ pointer on a referencescale ” in both Objectdisplays , but their accuracy had not improved in comparison to the SSSI Numericdisplay . The shape of the Objectdisplay improved performance of etiology determination compared to the Object Minus Shapesdisplay and SSSI Numericdisplay . Testing ( 10 trials ) was completed in less than 45 minutes . Conclusions .The new display with“emergent features ” can improve the diagnostic performance of clinicians The aim of this study was to quantify the impact of ProCCESs AWARE , Ambient Clinical Analytics , Rochester , MN , a novel acute care electronic medical record interface , on a range of care process and patient health outcome metrics in intensive care units ( ICUs ) . ProCCESs AWARE is a novel acute care EMR interface that contains built-in tools for error prevention , practice surveillance , decision support and reporting . We compared outcomes before and after AWARE implementation using a prospect i ve cohort and a historical control . The study population included all critically ill adult patients ( over 18 years old ) admitted to four ICUs at Mayo Clinic , Rochester , MN , who stayed in hospital at least 24 h. The pre-AWARE cohort included 983 patients from 2010 , and the post-AWARE cohort included 856 patients from 2014 . We analyzed patient health outcomes , care process quality , and hospital charges . After adjusting for patient acuity and baseline demographics , overall in-hospital and ICU mortality odds ratios associated with AWARE intervention were 0.45 ( 95 % confidence interval 0.30 to 0.70 ) and 0.38 ( 0.22 , 0.66 ) . ICU length of stay decreased by about 50 % , hospital length of stay by 37 % , and total charges for hospital stay by 30 % in post AWARE cohort ( by $ 43,745 after adjusting for patient acuity and demographics ) . Better organization of information in the ICU with systems like AWARE has the potential to improve important patient outcomes , such as mortality and length of stay , result ing in reductions in costs of care Family-centered care is becoming the new st and ard for Neonatal Intensive Care Unit ( NICU ) patients . In support of this , we developed the Physician PArent Decision Support System ( PPADS ) , which provides clinical up date s and predictions of clinical outcomes for infants in the NICU to the neonatologists , and provides an aid to parents for making difficult decisions on the direction of care of their infant with the health care team . The tool may lead to earlier intervention , better allocation of re sources , and reduction of the negative outcomes . The tool underwent a usability study with 8 parents whose infant survived the NICU stay and 5 neonatologists . Both parents and physicians thought the tool was easy to use , useful , and would help improve team communication . The next usability study will be with parents whose infant died while in the NICU , and then conduct a r and omized prospect i ve study with parents who have a sick infant admitted to the NICU BACKGROUND A novel monitoring system ( integrated monitor of anaesthesia , IMA ) which integrates three components of general anaesthesia on one single display was developed . The focus of this study was to evaluate the performance and user-friendliness of four different display design s. METHODS Four interface displays of the IMA were developed , including one numerical , one numerical and graphical ( mixed numerical-graphical ) , one only graphical , and one an advanced two-dimensional graphical display . Each of the four displays was evaluated in a r and om order by 10 staff anaesthetists and 10 residents/fellows using a set of five scenarios . Scenarios involved one or more abnormal variables that participants had to verbally phrase . For each interface test , reaction time , response accuracy , and NASA-Task Load Index were measured and compared . RESULTS The numerical , graphical , and advanced-graphical interfaces yielded similar median reaction times , respectively , 7.99 s ( 5.15 - 10.79 ) , 8.21 s ( 6.20 - 11.88 ) , and 9.43 s ( 6.19 - 13.3 ) . Reaction times were significantly shorter ( P<0.006 ) with the mixed numerical-graphical interface : 6.26 s ( 4.52 - 8.32 ) . The correct response rate was significantly lower in the graphical interface . The three others presented no statistical difference when compared among each other . The mixed numerical-graphical interface yielded a significantly lower NASA-TLX than the numerical and the advanced-graphical interfaces ( 19/100 vs 34/100 , P<0.003 ) . CONCLUSIONS A mixed numerical-graphical display design appears to present the best results in terms of user reaction times , response accuracy , and performance index when detecting abnormal critical events BACKGROUND Nurses ' ability to rapidly detect decreases in cerebral perfusion pressure ( CPP ) , which may contribute to secondary brain injury , may be limited by poor visibility of CPP displays . OBJECTIVE To evaluate the impact of a highly visible CPP display on the functional outcome in individuals with cerebral aneurysms . METHODS Patients with cerebral aneurysms ( n = 100 ) who underwent continuous CPP monitoring were enrolled and r and omized to beds with or without the additional CPP display . Six-month outcome was assessed . RESULTS Functional outcome was not significantly different between control and intervention groups after controlling for initial neurologic condition ( odds ratio .904 , 95 % confidence interval 0.317 to 2.573 ) . However , greater time below CPP thresholds ( 55 to 70 mm Hg ) was significantly associated with poorer outcome ( P = .005 to .010 ) . CONCLUSIONS Although the enhanced CPP display was not associated with significantly better outcome , longer periods of CPP below set levels were associated with poorer outcome This research evaluated physicians ' agreement about patients ' diagnoses and nurses ' ability to detect patient change using traditional charts ( TC ) and a work domain analysis -based paper prototype ( PP ) and also sought to determine whether differences persisted when the PP was represented as an electronic prototype ( EP ) . Nurses ' change detection improved using the PP and EP compared to TC ( PP vs TC , t((df=6))=1.94 , p<0.03 ; EP vs TC , t((df=6))=3.14 , p<0.01 ) and detection was better using the EP compared with the PP ( t((df=6))=5.96 , p<0.001 ) . Physicians were more likely to agree about failed physiological systems using the EP compared with the PP ( t((df=10))=3.14 , p<0.01 ) , but agreement about patient diagnoses was higher using the PP compared with the EP ( t((df=10))=2.23 ; p<0.02 ) . These results are attributed to information grouping around physiological functions and the direct association of cause- and -effect relations in clinical information design BACKGROUND Goal -directed therapy has a secure place in perioperative care . Algorithms are based on Starling 's law of the heart , notwithst and ing that this does not numerically define volume or heart performance variables . These have been developed based on a Guytonian view of the circulation and are implemented in a computerized decision support system ( Navigator ™ ) . We studied the feasibility and performance of the graphical display of the system in an intervention and a control group of patients undergoing major abdominal surgery . METHODS Patients were r and omized to either graphically ( intervention ) or numerically ( control ) guided administration of therapy . Goals were set and treatments and concordance with guidance noted , where applicable . Anaesthesia was provided by one of three experienced anaesthetists well acquainted with Navigator ™ . The primary objective was to determine whether the use of graphical display decision support more efficiently enables the achievement of oxygen delivery targets . This was quantitated as percentage time in the target zone and averaged st and ardized distance from the target centre . RESULTS The mean percentage time in the target zone was 36.7 % for control and 36.5 % for intervention . The averaged st and ardized difference was 1.5 in control and 1.6 in intervention . There was no significant difference in fluid balances . There was a high level of concordance between decision support recommendation and anaesthetist action ( 84.3 % ) . CONCLUSIONS In experienced h and s , the addition of a graphical display for haemodynamic guidance result ed in a similar time in target and averaged st and ardized difference . The haemodynamic guidance system should be explored in a comparative study to anaesthesia management without guidance Objective .Comprehensive monitoring of the patient state and subsequent decision making is an essential part of the task of ananaesthetist . The physicians ' decision making process is based upon aconcept of partly abstract physiologic parameters such as depth of anaesthesiaor contractility . This concept is derived from the measured parameters givenon todays ' trend displays in addition to context information availablefor the anaesthetist . We investigated two alternative approaches of display design for hemodynamic monitoring : 1 ) integrated displays based on ecologicalinterface design , and 2 ) profilogram displays based on intelligent alarms . Method .To evaluate differences in decision making , the two displays and a trend display were compared in an experimental set-up with computersimulated vital parameter curves . From a start state with r and om parameterdeviations from the ideal state , subjects had to achieve the ideal circulatoryperformance as fast as possible by manipulating vasomotor tone , heart rate , blood volume and contractility . To analyse subjects ' decision makingprocess , eye-tracking , event-logging , and the method of think aloud protocol swere used . Twenty anaesthesiologists performed 113 experiments ( approximately2 with each display ) . Results .The anaesthetists failed to achieve thetask in 37 % using the trend display , in 19 % using the profilogram display , and in 13 % using the ecological interface . Hence , a safer task solution waspossible with the ecological interface and the profilogram display but at theexpense of various performance parameters such as higher trial time , moreinteractions with the simulated system , and more frequent eye movements . Incontrast to the trend display and the profilogram display , where anaesthetistswere mainly focussed on controlling the left atrial pressure , such anbehaviour was less observed with the ecological interface . Conclusion .Our results have shown that subjects came to more effective solutions withthe traditional trend display . The main reason for this result may be theiryears of experience with this kind of display type . Regarding safe and goal -intended decision finding , the results are encouraging for furtherexperiments with re design ed ecological displays . But these displays ought tohave smoother changes with respect to the traditional trend displays . Furthermore , new experiments have to be performed under real or fairly real(e.g . together with an anaesthesia simulator ) conditions to underline thepositive results for ecological interfaces OBJECTIVES AWARE ( Ambient Warning and Response Evaluation ) is a novel electronic medical record ( EMR ) dashboard design ed by clinicians to support bedside clinical information management in the ICU . AWARE sits on top of pre-existing , comprehensive EMR systems . The purpose of the study was to test the acceptance and impact of AWARE on data management in live clinical ICU setting s. The primary outcome measure was observed efficiency of data utilization as determined by time spent in data gathering before morning rounds . DESIGN Step wedge cluster r and omization trial . SETTING Four ICUs ( surgical , medical , and mixed ) at an academic referral center . SUBJECTS All members of the critical care team participating in morning ICU rounds . INTERVENTION Pilot implementation of a novel EMR interface with direct observation and survey . MEASUREMENTS AND MAIN RESULTS The study took place between April and July 2012 . A total of 80 and 63 direct observations were made in the pre- and post-implementation study periods respectively . The time spent on pre-round data gathering per patient decreased from 12 ( 10 - 15 ) to 9 ( 7.3 - 11 ) min for pre- and post-implementation phases respectively ( p=0.03 ) . Compared to the existing EMR , information management ( data presentation format , efficiency of data access ) was reported to be better after AWARE implementation . AWARE made the task of gathering data for rounds significantly less difficult and mentally dem and ing . CONCLUSIONS The introduction of a novel , patient-centered EMR viewer for the ICU was associated with improved efficiency and ease of clinical data management compared to the st and ard EMR Anaesthesia involves processing large amounts of information over time . One task of the anaesthetist is to detect substantive changes in physiological variables promptly and reliably . It has been previously demonstrated that a graphical trend display of historical data leads to more rapid detection of such changes . We examined the effect of a graphical indication of the magnitude of Trigg 's Tracking Variable , a simple
Output:
| Implementing user-centered design ( UCD ) processes , especially iterative evaluation and re design , result ed in positive impact in outcomes such as accuracy and efficiency .
Improved information presentation can facilitate faster information interpretation and more accurate diagnoses and treatment . |
MS211413 | ***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: Introduction : In peritoneal dialysis ( PD ) patients , volume overload is related to cardiac dysfunction and mortality , while intravascular volume depletion is associated with a rapid decline in the residual renal function ( RRF ) . This study sought to determine the clinical usefulness of bioimpedance spectroscopy (BIS)-guided fluid management for preserving RRF and cardiac function in PD patients . Subjects and methods : This is a multicenter , prospect i ve , open-label study that was conducted over a 1-year period ( NCT01887262 ) . Non-anuric ( urine volume > 500 mL/day ) subjects on PD were enrolled . Subjects in the control group received fluid management based on the clinical information alone . Those in the BIS group received BIS-guided fluid management along with clinical information . Results : The subjects ( N = 137 , mean age 51.3 ± 12.8 years , 54 % male ) were r and omly assigned to the BIS group ( n = 67 ) or to the control group ( n = 70 ) . There were no significant differences between the 2 groups with regard to age , sex ratio , cause of kidney failure , duration of PD , baseline comorbidity , RRF , PD method , or peritoneal transport type . At baseline , the 2 groups were not different in terms of RRF ( glomerular filtration rate [ GFR ] , 5.1 ± 2.9 vs 5.5 ± 3.7 mL/min/1.73 m2 ) . After follow-up , changes in the GFR between the 2 groups were not different ( -1.5 ± 2.4 vs -1.3 ± 2.6 mL/min/1.73 m2 , p = 0.593 ) . Over the 1-year study period , both groups maintained stability of various fluid status parameters . Between the 2 groups , there were no differences in the net change of various fluid status parameters such as overhydration ( OH ) and extracellular water/total body water ( ECW/TBW ) . A net change in ECW over 1 year was slightly but significantly higher in the control group ( net increase , 0.57 ± 1.27 vs 0.05 ± 1.63 L , p = 0.047 ) . However , this difference was not translated into an improvement in RRF in the BIS group . There were no differences in echocardiographic parameters or arterial stiffness at the end of follow-up . Conclusion : Routine BIS-guided fluid management in non-anuric PD patients did not provide additional benefit in volume control , RRF preservation , or cardiovascular ( CV ) parameters . However , our study can not be generalized to the whole PD population . Further research is warranted in order to investigate the sub population of PD patients who may benefit from routine BIS-guided fluid management The number of published systematic review s of studies of healthcare interventions has increased rapidly and these are used extensively for clinical and policy decisions . Systematic review s are subject to a range of biases and increasingly include non-r and omised studies of interventions . It is important that users can distinguish high quality review s. Many instruments have been design ed to evaluate different aspects of review s , but there are few comprehensive critical appraisal instruments . AMSTAR was developed to evaluate systematic review s of r and omised trials . In this paper , we report on the updating of AMSTAR and its adaptation to enable more detailed assessment of systematic review s that include r and omised or non-r and omised studies of healthcare interventions , or both . With moves to base more decisions on real world observational evidence we believe that AMSTAR 2 will assist decision makers in the identification of high quality systematic review s , including those based on non-r and omised studies of healthcare interventions Purpose Fluid management with body composition monitor based on bioimpedance spectroscopy ( BCM-BIS ) has been found to be beneficial for dialysis patients . We conducted a study to provide an algorithm for the determination of post-dialysis target weight ( PDTW ) and to evaluate whether this approach could improve clinical outcomes compared to patients who had PDTW decided clinical ly . Methods Two hundred and ninety-eight dialysis patients participated in this 1-year r and omized controlled trial . The outcomes were all-cause hospitalization rate , AFO or CV-related events , hypertension and intra-dialysis morbidities . Results 80 % of post-dialysis weight reached the target set with current algorithm . All-cause hospitalization rate was not different . Incidence of acute fluid overload ( AFO ) or CV-related events was lower in study group . Longitudinal data showed decreased incidence of hypertension , intra-dialysis morbidities and intra-dialysis hypotension . Conclusions Assessment of PDTW by BCM-BIS with an explicit algorithm decreased AFO or CV-related events , hypertension and intra-dialysis morbidities . Further studies were required to demonstrate possible benefits of hospitalization rate BACKGROUND The relationship between blood pressure ( BP ) and mortality in hemodialysis patients has remained controversial . Some studies suggested that a lower pre- or postdialysis BP was associated with excess mortality , while others showed poorer outcome in patients with uncontrolled hypertension . We conducted a multicenter prospect i ve cohort study to evaluate the impact of hemodialysis-associated hypotension on mortality . METHODS We recruited 1244 patients ( 685 males ; mean age , 60 + /- 13 years ) who underwent hemodialysis in 28 units during the two-year study period beginning in December 1999 . Pre- , intra- , and postdialysis BP , and BP upon st and ing soon after hemodialysis , were measured in all patients at entry . Logistic regression analysis was used to assess the effect on mortality of pre- , intra- , and postdialysis BP , a fall in BP during hemodialysis , and a fall in BP upon st and ing soon after hemodialysis . RESULTS During the study period , 149 patients died . Logistic models identified the lowest intradialysis systolic blood pressure ( SBP ) and degree of fall in SBP upon st and ing soon after hemodialysis as significant factors affecting mortality , but not pre- or postdialysis SBP and diastolic BP . The adjusted odds ratio for death was 0.79 ( 95 % CI 0.64 - 0.98 ) when the lowest intradialysis SBP was analyzed in increments of 20 mm Hg , and was 0.82 ( 95 % CI 0.67 - 0.98 ) when the fall in SBP upon st and ing soon after hemodialysis was analyzed in increments of 10 mm Hg . CONCLUSION These results suggest that intradialysis hypotension and orthostatic hypotension after hemodialysis are significant and independent factors affecting mortality in hemodialysis patients BACKGROUND Fluid overload is the main determinant of hypertension and left ventricular hypertrophy in hemodialysis patients . However , assessment of fluid overload can be difficult in clinical practice . We investigated whether objective measurement of fluid overload with bioimpedance spectroscopy is helpful in optimizing fluid status . STUDY DESIGN Prospect i ve , r and omized , and controlled study . SETTING & PARTICIPANTS 156 hemodialysis patients from 2 centers were r and omly assigned to 2 groups . INTERVENTION Dry weight was assessed by routine clinical practice and fluid overload was assessed by bioimpedance spectroscopy in both groups . In the intervention group ( n = 78 ) , fluid overload information was provided to treating physicians and used to adjust fluid removal during dialysis . In the control group ( n = 78 ) , fluid overload information was not provided to treating physicians and fluid removal during dialysis was adjusted according to usual clinical practice . OUTCOMES The primary outcome was regression of left ventricular mass index during a 1-year follow-up . Improvement in blood pressure and left atrial volume were the main secondary outcomes . Changes in arterial stiffness parameters were additional outcomes . MEASUREMENTS Fluid overload was assessed twice monthly in the intervention group and every 3 months in the control group before the mid- or end-week hemodialysis session . Echocardiography , 48-hour ambulatory blood pressure measurement , and pulse wave analysis were performed at baseline and 12 months . RESULTS Baseline fluid overload parameters in the intervention and control groups were 1.45 ± 1.11 ( SD ) and 1.44 ± 1.12 L , respectively ( P = 0.7 ) . Time-averaged fluid overload values significantly decreased in the intervention group ( mean difference , -0.5 ± 0.8 L ) , but not in the control group ( mean difference , 0.1 ± 1.2 L ) , and the mean difference between groups was -0.5 L ( 95 % CI , -0.8 to -0.2 ; P = 0.001 ) . Left ventricular mass index regressed from 131 ± 36 to 116 ± 29 g/m(2 ) ( P < 0.001 ) in the intervention group , but not in the control group ( 121 ± 35 to 120 ± 30 g/m(2 ) ; P = 0.9 ) ; mean difference between groups was -10.2 g/m(2 ) ( 95 % CI , -19.2 to -1.17 g/m(2 ) ; P = 0.04 ) . In addition , values for left atrial volume index , blood pressure , and arterial stiffness parameters decreased in the intervention group , but not in the control group . LIMITATIONS Ambulatory blood pressure data were not available for all patients . CONCLUSIONS Assessment of fluid overload with bioimpedance spectroscopy provides better management of fluid status , leading to regression of left ventricular mass index , decrease in blood pressure , and improvement in arterial stiffness BACKGROUND The use of lung ultrasonography to evaluate extravascular lung water and its consequences has received growing attention in different clinical areas , including , in recent years , end-stage renal disease patients treated by haemodialysis ( HD ) . Lung congestion is a direct consequence of either overall overhydration and /or cardiac dysfunction , but the exact contribution of each of these tests to mortality is unknown . METHODS In this prospect i ve observational study , we enrolled 96 patients from a single HD unit undergoing thrice weekly HD . We used three different methods of evaluation : lung ultrasonography ( pre- and post-dialysis ) , bioimpedance spectroscopy ( pre- and post-dialysis ) and echocardiography ( pre-dialysis ) . The objective of the study was to test for the first time the prognostic value of ultrasound lung comets ( ULC ) combined with bioimpedance-derived data [ total body water ( TBW ) , extravascular water , hydration status-ΔHS ] and several echocardiographic parameters . Mortality was analysed after a median of 405.5-day follow-up . RESULTS Pre-dialysis lung congestion was classified as moderate ( ULC = 16 - 30 ) in 19.8 % of the patients and severe in 12.5 % of patients ( ULC > 30 ) , while only 19.8 % appear to be hyperhydrated ( ΔHS > 15 % ) . The pre-dialysis ultrasound lung congestion score correlated significantly with all of the bioimpedance-derived parameters . In a multivariate Cox model that included ULC score , demographic , ecocardiographic and bioimpedance parameters , the factors that remained significantly associated with survival time were the pre-dialysis ULC score and left ventricular mass index . The pre-HD ULC score has a significant discriminating power for survival , while the bioimpedance-derived hydration status has no discriminatory abilities in terms of survival . CONCLUSIONS To our knowledge , this study is the first one that compares three different strategies to predict mortality in haemodialysed patients . The lung comet score emerged as the best predictor for the relationship hydration status-mortality , independently of bioimpedance-derived parameters in this population Complications related to inadequate volume management are common during hemodialysis . This trial tested the hypothesis that availability of an intradialytic blood volume monitoring ( IBVM ) device improves fluid removal , reducing morbidity . A six-center , r and omized trial with 6 mo of intervention comparing IBVM using Crit-Line versus conventional clinical monitoring was conducted . The average rate of non-access-related hospitalizations was compared across treatment groups using Poisson regression . Mortality analysis used the Kaplan Meier method . A total of 227 patients were r and omized to Crit-Line , and 216 were r and omized to conventional monitoring . Both groups had similar baseline characteristics . During the study , no differences in weight , BP , or number of dialysis-related complications were observed . There were 120 and 81 non-access-related hospitalizations in the Crit-Line and conventional monitoring groups . The adjusted risk ratio for non-access-related and access-related hospitalization was 1.61 ( 95 % confidence interval 1.15 to 2.25 ; P = 0.01 ) and 1.52 ( 95 % confidence interval 1.02 to 2.28 ; P = 0.04 ) for the Crit-Line monitoring group . Mortality was 8.7 % in the Crit-Line monitoring group and 3.3 % in the conventional group ( P = 0.021 ) . St and ardized mortality ratios comparing the Crit-Line and conventional monitoring groups to the prevalent hemodialysis population were 0.77 ( NS ) and 0.26 ( P < 0.001 ) . Hospitalization rates were 1.51 and 1.03 events/yr in the Crit-Line and st and ard monitoring groups , compared
Output:
| Conclusions Among maintenance dialysis recipients , technological adjuncts for fluid management did not improve survival . |
MS211414 | ***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 Expectations congruently influence , or bias , pain perception . Recent social psychological research reveals that individuals differ in the extent to which they believe in expectation biases and that individuals who believe in expectation biases may adjust for this bias in their perceptions and reactions . That is , idiosyncratic beliefs about expectations can moderate the influence of expectations on experience . Purpose Prior research has not examined whether idiosyncratic beliefs about expectations can alter the degree to which one 's expectations influence pain perception . Using a laboratory pain stimulus , we examined the possibility that beliefs about expectation biases alter pain responses following both pain- and placebo-analgesic expectations . Methods Participants ' beliefs about expectation biases were measured . Next , participants were r and omly assigned to receive either a pain expectation or a placebo-analgesia expectation prior to a cold-pressor task . After the task , participants rated their pain . Results Beliefs about expectation biases significantly influenced pain reports . Specifically , pain reports were more influenced by provided expectations the less participants believed in expectation biases ( i.e. , pain expectations result ed in more pain than analgesia expectations ) . Conclusions Beliefs about the expectation bias are an important and under-examined predictor of pain and placebo analgesia The power of placebos has long been recognized for improving numerous medical conditions such as Parkinson 's disease ( PD ) . Little is known , however , about the mechanism underlying the placebo effect . Using the ability of endogenous dopamine to compete for [11C]raclopride binding as measured by positron emission tomography , we provide in vivo evidence for substantial release of endogenous dopamine in the striatum of PD patients in response to placebo . Our findings indicate that the placebo effect in PD is powerful and is mediated through activation of the damaged nigrostriatal dopamine system Rationale In a r and omised placebo-controlled clinical trial it is assumed that psychosocial effects of the treatment , regression to the mean and spontaneous remission are identical in the drug and placebo group . Consequently , any difference between the groups can be ascribed to the pharmacological effects . Previous studies suggest that side effects of drugs can enhance expectancies of treatment effects in the drug group compared to the placebo group , and thereby increase placebo responses in the drug group compared to the placebo group . Objectives The hypothesis that side effects of drugs can enhance expectancies and placebo responses was tested . Method Painful laser stimuli were delivered to 20 healthy subjects before and after administration of a drink with 0 or 4 mg/kg caffeine . The drink was administered either with information that it contained a painkiller or that it was a placebo . Laser-evoked potentials and reports of pain , expectancy , arousal and stress were measured . Results Four milligrammes per kilogramme of caffeine reduced pain . Information that a painkiller was administered increased the analgesic effect of caffeine compared to caffeine administered with no drug information . This effect was mediated by expectancies . Information and expectancies had no effect on pain intensity when 0 mg/kg was administered . Conclusion The analgesic effect of caffeine was increased by information that a painkiller was administered . This was due to an interaction of the pharmacological action of the drug and expectancies . Hence , psychosocial effects accompanying a treatment can differ when an active drug is administered compared to a placebo Applying the self-fulfilling prophecy ( SFP ) approach to combating seasickness , the authors experimentally augmented the self-efficacy of naval cadets by telling them that they were unlikely to experience seasickness and that , if they did , it was unlikely to affect their performance at sea . Naval cadets ( N = 25 ) in the Israel Defense Forces were r and omly assigned to experimental and control conditions . At the end of a 5-day training cruise , experimental cadets reported less seasickness and were rated as better performers by naive training officers than were the control cadets . There was a nonsignificant tendency for the experimental effects to be stronger among cadets of lower initial self-efficacy , suggestive of behavioral plasticity . Reducing seasickness by verbally enhancing self-efficacy is discussed as an application of " verbal placebo . " These findings extend the generalizability of the SFP-at-work model and suggest new arenas for its practical application CONTEXT Placebo and nocebo effects , the therapeutic and adverse effects , respectively , of inert substances or sham procedures , represent serious confounds in the evaluation of therapeutic interventions . They are also an example of cognitive processes , particularly expectations , capable of influencing physiology . OBJECTIVE To examine the contribution of 2 different neurotransmitters , the endogenous opioid and the dopaminergic ( DA ) systems , to the development of placebo and nocebo effects . DESIGN AND SETTING Using a within-subject design , subjects twice underwent a 20-minute st and ardized pain challenge , in the absence and presence of a placebo with expected analgesic properties . Studies were conducted in a university hospital setting . PARTICIPANTS Twenty healthy men and women aged 20 to 30 years recruited by advertisement . MAIN OUTCOME MEASURES Activation of DA and opioid neurotransmission by a pain stressor with and without placebo ( changes in the binding potential of carbon 11 [11C]-labeled raclopride and [ 11C ] carfentanil with positron emission tomography ) and ratings of pain , affective state , and anticipation and perception of analgesia . RESULTS Placebo-induced activation of opioid neurotransmission was detected in the anterior cingulate , orbitofrontal and insular cortices , nucleus accumbens , amygdala , and periaqueductal gray matter . Dopaminergic activation was observed in the ventral basal ganglia , including the nucleus accumbens . Regional DA and opioid activity were associated with the anticipated and subjectively perceived effectiveness of the placebo and reductions in continuous pain ratings . High placebo responses were associated with greater DA and opioid activity in the nucleus accumbens . Nocebo responses were associated with a deactivation of DA and opioid release . Nucleus accumbens DA release accounted for 25 % of the variance in placebo analgesic effects . CONCLUSIONS Placebo and nocebo effects are associated with opposite responses of DA and endogenous opioid neurotransmission in a distributed network of regions . The brain areas involved in these phenomena form part of the circuit typically implicated in reward responses and motivated behavior Placebo analgesia and reward processing share several features . For instance , expectations have a strong influence on the subsequent emotional experience of both . Recent imaging data indicate similarities in the underlying neuronal network . We hypothesized that placebo analgesia is a special case of reward processing and that placebo treatment could modulate emotional perception in the same way as does pain perception . The behavioral part of this study indicates that placebo treatment has an effect on how subjects perceive unpleasant pictures . Furthermore , event-related fMRI demonstrated that the same modulatory network , including the rostral anterior cingulate cortex and the lateral orbitofrontal cortex , is involved in both emotional placebo and placebo analgesia . These effects were correlated with the reported placebo effect and were predicted by the amount of treatment expectation induced on a previous day . Thus , the placebo effect may be considered to be a general process of modulation induced by the subjects ' expectations Identifying patients who are potential placebo responders has major implication s for clinical practice and trial design . Catechol-O-methyltransferase ( COMT ) , an important enzyme in dopamine catabolism plays a key role in processes associated with the placebo effect such as reward , pain , memory and learning . We hypothesized that the COMT functional val158met polymorphism , was a predictor of placebo effects and tested our hypothesis in a subset of 104 patients from a previously reported r and omized controlled trial in irritable bowel syndrome ( IBS ) . The three treatment arms from this study were : no-treatment ( “ waitlist ” ) , placebo treatment alone ( “ limited ” ) and , placebo treatment “ augmented ” with a supportive patient-health care provider interaction . The primary outcome measure was change from baseline in IBS-Symptom Severity Scale ( IBS-SSS ) after three weeks of treatment . In a regression model , the number of methionine alleles in COMT val158met was linearly related to placebo response as measured by changes in IBS-SSS ( p = .035 ) . The strongest placebo response occurred in met/met homozygotes treated in the augmented placebo arm . A smaller met/met associated effect was observed with limited placebo treatment and there was no effect in the waitlist control . These data support our hypothesis that the COMT val158met polymorphism is a potential biomarker of placebo response OBJECTIVE We investigated the effects of pain anxiety and a placebo/nocebo/neutral intervention on ice water-induced pain . DESIGN We divided 72 volunteers into high- and low-anxiety groups before r and omly assigning them to experimental and control subgroups . METHOD Participants completed preimmersion tests of pain anxiety , pain worry , and mood . We scored first immersion pain behavior , experience , and intensity . Each subgroup then received an instruction design ed to elicit a positive ( placebo ) , negative ( nocebo ) , or neutral response . After repeating the pain worry test , we gathered second immersion pain scores , and participants repeated the mood test , completed the treatment credibility measure , and were debriefed . OUTCOME MEASURES We used the Pain Anxiety Symptom Scale ; self-rating Likert-type scales for pain worry , pain intensity , and pain-coping ; the Multiple Affect Adjective Checklist ( mood ) ; timed measurements for pain threshold and pain tolerance ; and a treatment credibility scale . RESULTS Pain anxiety and the placebo interventions significantly altered participants ' pain scores , with best-to-worse scores reported by the low pain-anxiety/placebo , high anxiety/placebo , low anxiety/neutral , low anxiety/nocebo , high anxiety neutral , and high anxiety/nocebo groups . The high pain-anxiety group demonstrated the greatest response to the placebo/nocebo intervention in the expected directions in pain , worry , and anxious mood scores and in decreased self-confidence in managing pain ( this was also negatively affected by the nocebo in each pain-anxiety group ) . CONCLUSION This study demonstrates that the interaction of the personality variable of pain anxiety with the placebo/nocebo response has an impact on pain , worry , and mood OBJECTIVE This experiment tested the hypothesis that differences in subjects ' expectations about the impairing effect of alcohol on cognitive performance predict their responses to alcohol and to a placebo . METHOD Twenty-seven male social drinkers were r and omly assigned to one of three treatment groups : alcohol ( 0.62 g/kg ) , placebo , or no treatment control . All groups practice d a Rapid Information Processing Task that measured cognitive performance by the speed of information processed . After practice , they rated the degree of impairment they expected alcohol to have on their performance , and then performed the task under their different treatments . RESULTS Alcohol slowed ( i.e. , impaired ) information processing compared with placebo and no treatment . In addition , those who expected more impairment performed more poorly under alcohol , and under the placebo when alcohol was expected . When no beverage was received , no expectancy-performance relationship was obtained . CONCLUSIONS The findings call attention to expectancies as an important factor that may contribute to individual differences in cognitive functioning under alcohol and placebo OBJECTIVE Prior investigations have failed to find reliable personality differences in placebo responding . The present study tests the hypothesis that personality and situational variables interact to determine placebo responding . METHODS Optimists and pessimists were r and omly assigned to one of three conditions . In the first condition , the participants were told that they were to ingest a pill that would make them feel unpleasant ( deceptive-expectation group ) . In the second condition , the participants were told that they were to ingest a pill that would make them feel either unpleasant or was an inactive substance ( conditional-expectation group ) . Finally , a third group was told they were to ingest a pill that was inactive ( control group ) . RESULTS Pessimists were more likely than optimists to follow a negative-placebo expectation when given a deceptive expectation , but not when given a conditional expectation . CONCLUSION The personality variable optimism-pessimism relates to placebo responding when individuals are given a deceptive but not a conditional expectation . This suggests that personality and situational variables interact to determine placebo responding & NA ; This study reports how placebo analgesia was produced by conditioning whereby the intensity of electric stimulation was surreptitiously reduced in order to examine the contribution of psychological factors of suggestibility and expectancy on placebo analgesia . This strategy was used in order to manipulate expectancy for pain reduction . The magnitudes of the placebo effects were estimated after a manipulation procedure and during experimental trials in which stimulus intensities were reset to original baseline levels . Individual differences in suggestibility , verbal expectancy for drug efficacy and manipulation procedure for pain reduction were tested as possible mediators of placebo analgesia . The following dependent variables were measured : ( a ) subjective expectancy for drug efficacy in pain relief , ( b ) expected pain intensity and unpleasantness , ( c ) concurrent pain intensity and unpleasantness and ( d ) remembered pain intensity and unpleasantness . Statistically significant placebo effects on sensory and affective measures of pain were obtained independently of the extent of the surreptitious lowering of stimulus strength during manipulation trials . The pairing of placebo administration with painful stimulation was sufficient to produce a generalized placebo analgesic effect . However , verbal expectancy for drug efficacy and individual differences in suggestibility were found to contribute significantly to the magnitude of placebo analgesia . The highest placebo effect was shown by the most pronounced reductions in pain ratings in highly suggestible subjects who received suggestions presumed to elicit high expectancy for drug efficacy . The results also demonstrated that placebo effects established on remembered pain were at least twice as great as those obtained on concurrent placebo effects . This was mainly because baseline pain was remembered as being much more intense than it really was . Moreover , remembered placebo effects , like the concurrent placebo
Output:
| PRs mainly appear to be moderated by expectations of how the symptom might change after treatment , or expectations of how symptom repetition can be coped with . |
MS211415 | ***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 examine the impact of age and cognitive reserve on cognitive functioning in patients with breast cancer who are receiving adjuvant treatments . PATIENTS AND METHODS Patients with breast cancer exposed to chemotherapy ( n = 60 ; mean age , 51.7 years ) were evaluated with a battery of neuropsychological and psychological tests before treatment and at 1 , 6 , and 18 months after treatment . Patients not exposed to chemotherapy ( n = 72 ; mean age , 56.6 years ) and healthy controls ( n = 45 ; mean age , 52.9 years ) were assessed at matched intervals . RESULTS Mixed-effects modeling revealed significant effects for the Processing Speed and Verbal Ability domains . For Processing Speed , a three-way interaction among treatment group , age , and baseline cognitive reserve ( P < .001 ) revealed that older patients with lower baseline cognitive reserve who were exposed to chemotherapy had lower performance on Processing Speed compared with patients not exposed to chemotherapy ( P = .003 ) and controls ( P < .001 ) . A significant group by time interaction for Verbal Ability ( P = .01 ) suggested that the healthy controls and no chemotherapy groups improved over time . The chemotherapy group failed to improve at 1 month after treatment but improved during the last two follow-up assessment s. Exploratory analyses suggested a negative effect of tamoxifen on Processing Speed ( P = .036 ) and Verbal Memory ( P = .05 ) in the no-chemotherapy group . CONCLUSION These data demonstrated that age and pretreatment cognitive reserve were related to post-treatment decline in Processing Speed in women exposed to chemotherapy and that chemotherapy had a short-term impact on Verbal Ability . Exploratory analysis of the impact of tamoxifen suggests that this pattern of results may be due to a combination of chemotherapy and tamoxifen BACKGROUND Owing to its neurotoxicity , allogeneic hematopoietic stem cell transplantation ( HSCT ) carries risks for cognitive impairment . In this multicenter study , we prospect ively evaluated cognitive functioning and its medical and demographic correlates in patients undergoing allogeneic HSCT . METHODS A total of 102 patients were consecutively assessed prior to ( T0 ) , 100 ± 20 days ( T1 ) after , and 12 ± 1 months ( T2 ) after HSCT ( 61 % men , 41 % acute myeloid leukemia ) . A comprehensive neuropsychological test battery was applied to evaluate attention , memory , executive function , and fine motor function , summing up into 14 test scores . RESULTS Before and after HSCT , patients performed below test norms in up to 50 % of the test scores . Patients were mostly impaired on word fluency ( 24 % , T0 ) , fine motor function , and verbal delayed recall ( 19 % each , T2 ) . Impairment on ≥ 1/5 cognitive domains occurred in 47 % ( T0 ) and 41 % ( T2 ) of the patients . Performance ( mean z-scores ) partially improved over time ( i.e. , visual span forward , verbal learning , and word fluency ) . However , from baseline to T2 , 16 % of the patients showed reliable decline on ≥ 3/14 test scores ( reliable change index method ) . For the majority of neuropsychological subtests , no associations with conditioning intensity , total body irradiation , graft-versus-host disease , cyclosporine treatment , and length of hospital stay were found . Age and premorbid intelligence level were consistently associated with cognition . CONCLUSIONS Below average cognitive performance is common in this patient group . In addition , a subgroup shows reliable cognitive decline after allogeneic HSCT . Healthcare professionals should be aware of these treatment-related cognitive side effects PURPOSE Prospect i ve evaluation of chronic radiation effects on the healthy adult brain using neuropsychological testing of intelligence , attention , and memory . METHODS AND MATERIAL S 58 patients ( 43 + /- 10 yr ) undergoing hyperfractionated total body irradiation ( TBI ) ( TBI , 14.4 Gy , 12 x 1.2 Gy in 4 days ) before bone marrow or peripheral blood stem cell transplantation were prospect ively included . Twenty-one recurrence-free long-term survivors were re-examined 6 - 36 months ( median 27 months ) after completion of TBI . Neuropsychological testing included assessment of general intelligence , attention , and memory using normative , st and ardized psychometric tests . Mood status was controlled , as well . Test results are given as IQ scores ( population mean 100 ) or percentiles for attention and memory ( population mean 50 ) . RESULTS The 21 patients showed normal baseline test results of IQ ( 101 + /- 13 ) and attention ( 53 + /- 28 ) , with memory test scores below average ( 35 + /- 21 ) . Test results of IQ ( 98 + /- 17 ) , attention ( 58 + /- 27 ) , and memory ( 43 + /- 28 ) showed no signs of clinical ly measurable radiation damage to higher CNS ( central nervous system ) functions during the follow-up . The mood status was improved . CONCLUSION The investigation of CNS toxicity after hyperfractionated TBI showed no deterioration of test results in adult recurrence-free patients with tumor-free CNS . The median follow-up of 27 months will be extended PURPOSE Research has documented cognitive deficits both before and after high-dose treatment followed by allogeneic hematopoietic cell transplantation ( HCT ) , with partial recovery by 1 year . This study prospect ively examined the trajectory and extent of long-term cognitive dysfunction , with a focus on 1 to 5 years after treatment . PATIENTS AND METHODS Allogeneic HCT recipients completed st and ardized neuropsychological tests including information processing speed ( Trail Making A and Digit Symbol Substitution Test ) , verbal memory ( Hopkins Verbal Learning Test-Revised ) , executive function ( Controlled Oral Word Association Test and Trail Making B ) , and motor dexterity and speed ( Grooved Pegboard ) . Survivors ( n = 92 ) were retested after 80 days and 1 and 5 years after transplantation . Case-matched controls ( n = 66 ) received testing at the 5-year time point . A Global Deficit Score ( GDS ) summarized overall impairment . Response profiles were analyzed using linear mixed effects models . RESULTS Survivors recovered significant cognitive function from post-transplantation ( 80 days ) to 5 years in all tests ( P < .0001 ) except verbal recall ( P > .06 ) . Between 1 and 5 years , verbal fluency improved ( P = .0002 ) , as did executive function ( P < .01 ) , but motor dexterity did not ( P > .15 ) , remaining below controls ( P < .0001 ) and more than 0.5 st and ard deviation below population norms . In GDS , 41.5 % of survivors and 19.7 % of controls had mild or greater deficits ( NcNemar test = 7.04 , P = .007 ) . CONCLUSION Although neurocognitive function improved from 1 to 5 years after HCT , deficits remained for more than 40 % of survivors . Risk factors , mechanisms and rehabilitation strategies need to be identified for these residual deficits Longitudinal data of neurocognitive functions and quality of life ( QOL ) were obtained for a cohort of 25 patients followed before transplant and through the first year after haematopoietic stem cell transplantation ( SCT ) . A battery of neuropsychological tests and two self-report question naires were used to assess neurocognitive functions , QOL and psychological functioning . In comparison to normative data , up to one-fourth of the patients experienced impaired functioning on several cognitive domains before SCT . R and om regression modelling revealed a slight improvement in the mean group scores of memory tasks over time , especially for younger patients . Impairment in neurocognitive functions was positively related to depression and anger at baseline , and to the emotional functioning scale at follow-up . These preliminary results emphasize the significance of a pre-treatment assessment and the need of a large baseline sample in future longitudinal studies to overcome the expected dropout rate of more than 50 % PURPOSE Total body irradiation ( TBI ) in preparation for bone marrow transplantation ( BMT ) is a routine treatment of hematological malignancy . A retrospective and a prospect i ve group study of long-term cerebral side effects was performed , with a special emphasis on neurobehavioral toxicity effects . METHODS AND MATERIAL S Twenty disease-free patients treated with hyperfractionated TBI ( 14.4 Gy , 12 x 1.2 Gy , 4 days ) , 50 mg/kg cyclophosphamide , and autologous BMT ( mean age 38 years , range 17 - 52 years ; age at TBI 35 years , 16 - 50 years ; follow-up time 32 months , 9 - 65 months ) participated in a neuropsychological , neuroradiological , and neurological examination . Data were compared to 14 patients who were investigated prior to TBI . Eleven patients with renal insufficiencies matched for sex and age ( 38 years , 20 - 52 years ) served as controls . In a longitudinal approach , neuropsychological follow-up data were assessed in 12 long-term survivors ( 45 years , 23 - 59 years ; follow-up time 8.8 years , 7 - 10.8 years ; time since diagnosis 10.1 years , 7.5 - 14.2 years ) . RESULTS No evidence of neurological deficits was found in post-TBI patients except one case of peripheral movement disorder of unknown origin . Some patients showed moderate brain atrophy . Neuropsychological assessment showed a subtle reduction of memory performance of about one st and ard deviation . Cognitive decline in individual patients appeared to be associated with pretreatment ( brain irradiation , intrathecal methotrexate ) . Ten-years post disease onset , survivors without pretreatment showed behavioral improvement up to the premorbid level . CONCLUSION The incidence of long-term neurobehavioral toxicity was very low for the present TBI/BMT regimen During bone marrow or haematopoietic stem-cell transplantation ( HSCT ) , potentially neurotoxic treatments are used . Previous studies identified cognitive disturbances in patients treated with HSCT , but prospect i ve studies with longitudinal assessment are sparse . We examined cognitive functions up to 20 months after a first baseline assessment in 101 patients undergoing HSCT and in 82 reference patients with a haematological malignancy treated with non-myeloablative cancer therapies . Baseline findings revealed no between-group differences and demonstrated mild cognitive impairments in both groups . Follow-up analyses showed no significant changes over time , though poorer performance in attention and executive function , and psychomotor function was found in HSCT patients . Our results suggest limited HSCT-related cognitive dysfunctions . Additional follow-up is necessary to assess long-term effects The growing numbers of survivors of innovative cancer treatments , such as hematopoietic stem cell transplantation ( HSCT ) , often report subsequent cognitive difficulties . The objective of this study was to evaluate and compare neurocognitive changes in patients with chronic myelogenous leukemia ( CML ) or primary myelodysplastic syndrome ( MDS ) after allogeneic HSCT or other therapies Objective : To determine the spectrum and frequency of neurologic sequelae after allogeneic bone marrow transplantation ( BMT ) and to define a risk profile of the patients . Methods : A prospect i ve follow-up of 71 allogeneic bone marrow recipients 14 ± 3 months after transplantation . Patients underwent a neurologic examination , a neuropsychological test battery , and cranial MRI before and after BMT . Results : A large proportion of patients ( 65 % ) developed sequelae after BMT . Acute complications of defined etiology occurred in 18 % of the patients and led to death in 9 % of the study population . A total of 47 % of the patients developed new neurologic abnormalities of undefined origin that were mild and subacute and predominantly affected the peripheral nervous system . The cognitive and neuroradiologic outcome was favorable in a majority of these patients , but a small subgroup exhibited cognitive deterioration and white matter lesions . Risk factor analysis identified acute graft-versus-host disease ( GvHD ) and other variables partly related to GvHD such as long-lasting immunosuppression as the main predictors of sequelae after allogeneic BMT . The authors have established an association with various factors but , owing to the observational character of this study , conclusions about the etiology of the findings are unclear . Conclusion : Neurologic complications significantly contribute to the morbidity and mortality of patients receiving allogeneic BMT . Sub clinical abnormalities , cognitive deficits , and white matter lesions detected 1 year after BMT in a subgroup of patients may be related to more extensive CNS changes observed after transplantation in an earlier retrospective study and may be associated with the risk factor chronic GvHD/immunosuppression Although delirium is a common medical comorbidity with altered cognition as its defining feature , few publications have addressed the neuropsychological prodrome , profile , and recovery of patients tested during delirium . We characterize neuropsychological performance in 54 hemapoietic stem cell/bone marrow transplantation ( BMT ) patients shortly before , during , and after delirium and in BMT
Output:
| There was agreement that cognitive impairments are evident for a subset of patients before HCT .
Age , time since transplant and TBI were not associated with changes in cognitive functioning .
Nevertheless , results from the current meta- analysis suggest that cognitive functioning does not significantly change following HCT |
MS211416 | ***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 The aim of the study was to develop a scoring model to evaluate the quality of bioresorbable vascular scaffold ( BVS ) implantation and determine the model 's usefulness in predicting adverse cardiac events . METHODS AND RESULTS The implantation technique and clinical outcomes of 1,736 lesions treated with BVS were analysed using the GHOST-EU registry . Predilation , scaffold sizing , and post-dilation ( PSP ) were scored according to the hazard model derived from the weight of these variables . The primary endpoint was a one-year device-oriented composite endpoint ( DoCE ) composed of cardiac death , target vessel myocardial infa rct ion , and clinical ly driven target lesion revascularisation . Definite/probable scaffold thrombosis was also evaluated as defined by the Academic Research Consortium . The PSP model performance was evaluated by internal validation . Predilation , correct scaffold sizing , and post-dilation with a non-compliant balloon were performed in 95.7 % , 50.2 % , and 26.2 % of the cases and scored 0.63 , 1.96 and 1.93 points , respectively , in the PSP-1 model . PSP-1 was an independent predictor of one-year DoCE ( HR 0.75 , 95 % CI : 0.61 - 0.93 ; p=0.007 ) , but with poor calibration and discrimination ( AUC 0.611 , 95 % CI : 0.545 - 0.677 ) . No patient with a maximum PSP-1 score had scaffold thrombosis , compared to those with a non-maximum PSP-1 score ( 0 % vs. 2.3 % ; p=0.095 ) . CONCLUSIONS At one-year follow-up , the PSP-1 score was an independent predictor of DoCE . External validation and prospect i ve studies are needed to determine the clinical usefulness of this score OBJECTIVES We evaluated clinical results up to 36 months after implantation of Absorb BVS using PSP-technique and compared the outcome of patients with and without diabetes mellitus . BACKGROUND Absorb II demonstrated that interventional treatment of coronary artery disease with bioresorbable vascular scaffolds ( BVS ) without proper PSP-technique ( pre-dilation , proper sizing , and post-dilation ) is associated with an increased thrombotic risk , even in simple lesions . METHODS In this prospect i ve study 319 patients with 420 lesions were enrolled and treated with the Absorb BVS . Pre-dilation was m and atory and post-dilation with a high-pressure balloon was performed in patients with a scaffold length > 12 mm . Patients were clinical ly followed up to 3 years . Primary outcome measure was the device-oriented endpoint ( DoCE ) defined as cardiac death , myocardial infa rct ion not clearly related to a non-target vessel and target lesion revascularization . RESULTS DoCE was 5.0 % , 7.1 % , and 10.0 % after 12 , 24 , and 36 months for the total population . Rate of scaffold thrombosis was 0.5 % , 0.8 % , and 1.4 % after 12 , 24 , and 36 months . Rate of DoCE was higher in the diabetic subgroup with 9.1 % , 12.6 % , and 12.9 % after 12 , 24 , and 36 months compared with 4.0 % ( P = 0.13 ) , 5.6 % ( P = 0.05 ) , and 9.9 % ( P = 0.20 ) in patients without diabetes mellitus . CONCLUSIONS Patients treated with the Absorb BVS using the PSP-technique show good results up to 3 years with a low rate of scaffold thrombosis . Patients suffering from diabetes mellitus have an increased rate of DoCE compared with non-diabetic patients . CLINICAL TRIAL REGISTRATION clinical trials.gov_NCT02162056 BACKGROUND Data from r and omized controlled trials have shown that the ABSORB BVS is non-inferior to Cobalt Chromium everolimus-eluting stents at 2years . METHODS & RESULTS The EVERBIO II trial ( Comparison of Everolimus- and Biolimus-Eluting Coronary Stents with Everolimus-Eluting Bioresorbable Vascular Scaffold ) is a single-center , assessor-blind , r and omized controlled trial enrolling 240 patients with an allocation ration of 1:1:1 conducted at University and Hospital Fribourg , Switzerl and . The studied devices were an everolimus-eluting persistent polymer stent ( EES ) , a biolimus-eluting stent with bioabsorbable polymer ( BES ) and a fully bioresorbable vascular scaffold ( BVS ) . Clinical end points collected at 9months , 12months , and 2years , were academic research consortium defined composites , device thrombosis and target-vessel revascularization . Clinical follow-up at 2years was available in 96 % ( N=77 ) of patients in the EES group , in 100 % ( N=80 ) in the BES and 99 % ( N=77 ) in the BVS group . The device-oriented composite end point of cardiac death , target-vessel myocardial infa rct ion and target-lesion revascularization occurred in 13 ( 16 % ) patients treated with EES , in 7 ( 9 % ) patients treated with BES and in 16 ( 21 % ) patients treated with BVS . There was no significant difference when the metallic stents were compared to the BVS ( p=0.12 ) . There was one late scaffold thrombosis throughout the trial in the BVS group , and no definite stent thrombosis in either EES or BES treated patients . CONCLUSIONS The current analysis shows no significant differences with regard to clinical outcomes at 2years between BVS and the best-in-class metallic DES . Event rates were numerically higher in BVS-treated patients . However , when BVS were compared to BES alone , the occurrence of device related adverse events was significantly increased BACKGROUND In patients with coronary artery disease who receive metallic drug-eluting coronary stents , adverse events such as late target-lesion failure may be related in part to the persistent presence of the metallic stent frame in the coronary-vessel wall . Bioresorbable vascular scaffolds have been developed to attempt to improve long-term outcomes . METHODS In this large , multicenter , r and omized trial , 2008 patients with stable or unstable angina were r and omly assigned in a 2:1 ratio to receive an everolimus-eluting bioresorbable vascular ( Absorb ) scaffold ( 1322 patients ) or an everolimus-eluting cobalt-chromium ( Xience ) stent ( 686 patients ) . The primary end point , which was tested for both noninferiority ( margin , 4.5 percentage points for the risk difference ) and superiority , was target-lesion failure ( cardiac death , target-vessel myocardial infa rct ion , or ischemia-driven target-lesion revascularization ) at 1 year . RESULTS Target-lesion failure at 1 year occurred in 7.8 % of patients in the Absorb group and in 6.1 % of patients in the Xience group ( difference , 1.7 percentage points ; 95 % confidence interval , -0.5 to 3.9 ; P=0.007 for noninferiority and P=0.16 for superiority ) . There was no significant difference between the Absorb group and the Xience group in rates of cardiac death ( 0.6 % and 0.1 % , respectively ; P=0.29 ) , target-vessel myocardial infa rct ion ( 6.0 % and 4.6 % , respectively ; P=0.18 ) , or ischemia-driven target-lesion revascularization ( 3.0 % and 2.5 % , respectively ; P=0.50 ) . Device thrombosis within 1 year occurred in 1.5 % of patients in the Absorb group and in 0.7 % of patients in the Xience group ( P=0.13 ) . CONCLUSIONS In this large-scale , r and omized trial , treatment of noncomplex obstructive coronary artery disease with an everolimus-eluting bioresorbable vascular scaffold , as compared with an everolimus-eluting cobalt-chromium stent , was within the prespecified margin for noninferiority with respect to target-lesion failure at 1 year . ( Funded by Abbott Vascular ; ABSORB III Clinical Trials.gov number , NCT01751906 . ) A previous Task Force of the European Society of Cardiology ( ESC ) and European Association of Percutaneous Cardiovascular Interventions ( EAPCI ) provided a report on recommendations for the non- clinical and clinical evaluation of coronary stents . Following dialogue with the European Commission , the Task Force was asked to prepare an additional report on the class of devices known as bioresorbable scaffolds ( BRS ) . Five BRS have CE-mark approval for use in Europe . Only one device-the Absorb bioresorbable vascular scaffold-has published r and omized clinical trial data and this data show inferior outcomes to conventional drug-eluting stents ( DES ) at 2 - 3 years . For this reason , at present BRS should not be preferred to conventional DES in clinical practice . The Task Force recommends that new BRS devices should undergo systematic non- clinical testing according to st and ardized criteria prior to evaluation in clinical studies . A clinical evaluation plan should include data from a medium sized , r and omized trial against DES powered for a surrogate end point of clinical efficacy . Manufacturers of successful devices receive CE-mark approval for use and must have an approved plan for a large-scale r and omized clinical trial with planned long-term follow-up AIMS The present multicentre prospect i ve study , IT-DISAPPEARS , was design ed with the aim of evaluating early and long-term clinical outcomes of the Absorb BVS in patients with long coronary lesions and /or multivessel coronary artery disease . The aim of this article is to present the one-year clinical results of this study . METHODS AND RESULTS Between November 2014 and January 2016 , we enrolled 1,002 patients undergoing BVS implantation ( long lesion [ ≥ 24 mm ] of a single vessel in 80.4 % , at least two BVS in two or three coronary vessels in 8.6 % and both criteria in 11 % ) . Clinical presentation was an acute coronary syndrome in 59.8 % of patients , including ST-elevation myocardial infa rct ion in 21.8 % . The primary endpoint was the device-oriented composite endpoint ( DOCE ) of cardiac death , target vessel MI , and ischaemia-driven TLR at one year . We implanted 2,040 BVS according to a pre-specified technique . One-year follow-up was available in 956 patients ( 95.4 % ) . The rate of DOCE was 9.9 % ( 95 patients ) . Cardiac death occurred in five patients ( 0.5 % ) , while target vessel MI and TLR each occurred in 45 ( 4.7 % ) patients . The one-year rates of all-cause death , non-fatal MI , and any revascularisation were 1.2 % , 5.4 % , and 10.9 % , respectively . The rate of definite/probable scaffold thrombosis was 0.9 % . CONCLUSIONS This is the first study specifically investigating the Absorb technology in patients with a high atherosclerotic burden and multivessel disease . The m and atory adherence to a pre-specified implantation technique led to minimising the risk of device failure reported by other studies , in particular with respect to the rate of DOCE and scaffold thrombosis AIMS The MeRes-1 trial sought to study the safety and effectiveness of a novel sirolimus-eluting bioresorbable vascular scaffold ( MeRes100 BRS ) in treating de novo native coronary artery lesions by clinical evaluation and using multiple imaging modalities . METHODS AND RESULTS The MeRes-1 first-in-human trial was a single-arm , prospect i ve , multicentre study , which enrolled 108 patients with de novo coronary artery lesions ( 116 scaffolds were deployed to treat 116 lesions in 108 patients ) . At six months , quantitative coronary angiography revealed in-scaffold late lumen loss of 0.15±0.23 mm with 0 % binary restenosis . Optical coherence tomography demonstrated minimum scaffold area ( 6.86±1.73 mm2 ) and percentage neointimal strut coverage ( 99.30 % ) . Quantitative intravascular ultrasound analysis confirmed a 0.14±0.16 mm2 neointimal hyperplasia area . At one year , major adverse cardiac events , a composite of cardiac death , any myocardial infa rct ion and ischaemia-driven target lesion revascularisation , occurred in only one patient ( 0.93 % ) and there was no scaffold thrombosis reported . At one year , computed tomography angiography demonstrated that all scaffolds were patent and in-scaffold mean percentage area stenosis was 11.33±26.57 % . CONCLUSIONS The MeRes-1 trial demonstrated the safety and effectiveness of MeRes100 BRS . The favourable clin
Output:
| At mid-term follow-up , BVS was associated with an increased risk of TLF , MI , TLR and definite/probable device thrombosis , but this did not result in an increased risk of all-cause mortality |
MS211417 | ***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 diagnosis of a meniscal tear may require MRI , which is costly . Ultrasonography has been used to image the meniscus , but there are no reliable data on its accuracy . We performed a prospect i ve study investigating the sensitivity and specificity of ultrasonography in comparison with MRI ; the final outcome was determined at arthroscopy . The study included 35 patients with a mean age of 47 years ( 14 to 73 ) . There was a sensitivity of 86.4 % ( 95 % confidence interval ( CI ) 75 to 97.7 ) , a specificity of 69.2 % ( 95 % CI 53.7 to 84.7 ) , a positive predictive value of 82.6 % ( 95 % CI 70 to 95.2 ) and a negative predictive value of 75 % ( 95 % CI 60.7 to 81.1 ) for ultrasonography . This compared favourably with a sensitivity of 86.4 % ( 95 % CI 75 to 97.7 ) , a specificity of 100.0 % , a positive predictive value of 100.0 % and a negative predictive value of 81.3 % ( 95 % CI 74.7 to 87.9 ) for MRI . Given that the sensitivity matched that of MRI we feel that ultrasonography can reasonably be applied to confirm the clinical diagnosis before undertaking arthroscopy . However , the lower specificity suggests that there is still a need to improve the technique to reduce the number of false-positive diagnoses and thus to avoid unnecessary arthroscopy High resolution ultrasonography was done prospect ively in 51 adult patients with clinical ly suspected meniscal injuries to evaluate the sensitivity and specificity of ultrasonography as a primary diagnostic tool and to see if it was possible to evaluate the site , extent and size of the tear . All cases were confirmed arthroscopically ; ultrasonographic examination revealed inhomogenecity in 45 cases and this was accurate in 40 cases ; in 3 cases ultrasonography gave a false positive result and in 2 cases the wrong meniscus was shown to be torn . The six cases with no findings on ultrasonography were proven to have no meniscal tear . The sensitivity of ultrasonography as a screening test to rule out meniscal injuries was thus 100 % ; on the other h and the specificity ( false positive screening test ) was 54 % . It was no possible to determine the site , size or extent of the tear by the ultrasonographic examination . Even though magnetic resonance imaging is more accurate in giving an exact diagnosis , ultrasonography is an excellent primary diagnostic tool which is inexpensive with no side-effects , is readily available and has very good sensitivity and a reasonable specificity While magnetic resonance imaging ( MRI ) is often considered the " gold st and ard " diagnostic imaging modality for detection of meniscal abnormalities , it is associated with misdiagnosis in as high as 47 % of cases , is costly , and is not readily available to a large number of patients . Ultrasonographic examination of the knee has been reported to be an effective diagnostic tool for this purpose with the potential to overcome many of the shortcomings of MRI . The purpose of this study is to determine the clinical usefulness of ultrasonography for diagnosis of meniscal pathology in patients with acute knee pain and compare its diagnostic accuracy to MRI in a clinical setting . With Institutional Review Board approval , patients ( n = 71 ) with acute knee pain were prospect ively enrolled with informed consent . Preoperative MRI ( 1.5 T ) was performed on each affected knee using the hospital 's st and ard equipment and protocol s and read by faculty radiologists trained in musculoskeletal MRI . Ultrasonographic assessment s of each affected knee were performed by one of two faculty members trained in musculoskeletal ultrasonography using a 10 to 14 MHz linear transducer . Arthroscopic evaluation of affected knees was performed by one of three faculty orthopedic surgeons to assess and record all joint pathology , which served as the reference st and ard for determining presence , type , and severity of meniscal pathology . All evaluators for each diagnostic modality were blinded to all other data . Data were collected and compared by a separate investigator to determine sensitivity ( Sn ) , specificity ( Sp ) , positive predictive value ( PPV ) , negative predictive value ( NPV ) , correct classification rate ( CCR ) , likelihood ratios ( LR[+ ] and LR[- ] ) , and odds ratios . Preoperative ultrasonographic assessment of meniscal pathology was associated with Sn = 91.2 % , Sp = 84.2 % , PPV = 94.5 % , NPV = 76.2 % , CCR = 89.5 % , LR(+ ) = 5.78 , and LR(- ) = 0.10 . Preoperative MRI assessment of meniscal pathology was associated with Sn = 91.7 % , Sp = 66.7 % , PPV = 84.6 % , NPV = 80.0 % , CCR = 81.1 % , LR(+ ) = 2.75 , and LR(- ) = 0.13 . Ultrasonography was two times more likely than MRI to correctly determine presence or absence of meniscal pathology seen arthroscopically in this study . Ultrasonography is a useful tool for diagnosis of meniscal pathology with potential advantages over MRI . Based on these data and available portable equipment , ultrasonography could be considered for use as a point-of-injury diagnostic modality for meniscal injuries PURPOSE The aim of this prospect i ve study was to evaluate preoperative three-dimensional ultrasound scans for the detection of meniscal lesions with a special focus on interobserver reliability . METHODS Forty one patients with clinical signs of meniscal lesions were preoperatively examined by ultrasound using the 3-D technique ( 11.7 MHz linear transducer ) . The 3-D data set was stored and examined by a second orthopaedic surgeon . The second ultrasound examiner was blinded to the results of the first . Any meniscal pathology was confirmed arthroscopically and documented . RESULTS At arthroscopy eight lateral meniscal lesions and 57 medial meniscal lesions were detected at different locations . The sensitivity and specificity of the original ultrasound examination was acceptable whereas the results of the second ultrasound session were not as sensitive . CONCLUSION Three-D-ultrasound with a high resolution transducer , in the h and s of an experienced operator , provides acceptable results in the detection of meniscal lesions , however , analysis of the volume data set from the 3-D ultrasound investigation indicates that it does not offer sufficient accuracy for clinical use Purpose To prospect ively evaluate whether age of patient affects diagnostic accuracy of sonography and magnetic resonance imaging ( MRI ) in the diagnosis of medial meniscal tears . Methods We prospect ively evaluated 74 consecutive patients ( 54 males and 20 females ) , in two different groups [ group A ( 37 patients ≤ 30 years ; mean age : 23.5 ± 5 years ) and group B ( 37 patients > 30 years ; mean age : 43.5 ± 9.35 years ) ] with clinical suspicion of medial meniscal tear . After inclusion , patients underwent ultrasonography and then MRI for signs of tearing . The ultrasonographic and MRI findings were compared with arthroscopic findings , which served as a gold st and ard for accurate detection of meniscal tearing . Results The sensitivity , specificity , positive and negative predictive values and accuracy of ultrasonography in detecting medial meniscal tears in group A were 100 , 88.9 , 96.5 , 100 , 97.3 % and in group B were 83.3 , 71.4 , 92.6 , 50 , 81.1 % , respectively . The sensitivity , specificity , positive and negative predictive values and accuracy of MRI in group A were 100 , 88.9 , 96.5 , 100 , 97.3 % and in group B were 96.7 , 85.7 , 96.7 , 85.7 , 94.6 % , respectively . Conclusions Given the fact that the sensitivity and specificity of the results of knee sonography matched that of MRI in patients who were 30 years old or less , we suggest ultrasonography as an effective initial investigation for tears of medial meniscus in this group of patients . Patients with negative ultrasonographic findings will need no further investigation . Level of evidence Diagnostic studies —investigating a diagnostic test , Level II In a prospect i ve double-blind study we investigated internal knee disorders with ultrasound and compared the results with Magnetic Resonance Imaging ( MRI ) and arthroscopy . The aim was to determine the effectiveness of ultrasound in diagnosing Internal Derangement of the Knee ( IDK ) and to compare the results with MRI . Over an 18-months period , 81 patients were examined . All were male ; they had a mean age of 35 years . For various technical reasons 21 patients were subsequently excluded from the study . After initial clinical examinations , patients had an ultrasound and MRI scan at the same visit . Arthroscopy was performed within a month of this . Different radiologists who were unaware of the clinical findings independently reported on the ultrasound and MRI . The surgeon performing the arthroscopy was made aware only of the MRI findings . Structures accessed were the lateral and medial menisci and the anterior ( ACL ) and posterior ( PCL ) cruciate ligaments . Arthroscopy was taken as the gold st and ard . Ultrasound showed good sensitivity , ranging from 76 % for the ACL to 90 % for the medial meniscus , and excellent specificity , ranging from 92 % for the medial meniscus to 100 % for the ACL . Accuracy ranged from 86 % for the ACL to 98 % for the lateral meniscus . These figures were comparable to the MRI findings . We concluded that ultrasound is a simple , accurate , inexpensive and non-invasive way of assessing internal knee disorders . There is a learning curve , but results are similar to MRI 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 The aim of this prospect i ve study was to assess the accuracy of modern ultrasonography in diagnostic imaging of meniscal tears . One hundred and sixty menisci were evaluated in 80 patients ( 42 females , 38 males , mean age=36.2 years , range=16 - 70 years ) . Inclusion criteria for the study were twofold : clinical suspicion of meniscal injury and clinical indication for arthroscopy . Knee examination was performed with the Voluson 730 Expert ultrasound system ( General Electric ) . After sonographic examination , all patients underwent arthroscopic procedures within 1 - 4 days . The final diagnosis of meniscal tears was taken from surgical reports . The overall sensitivity , specificity , positive predictive value and negative predictive value of sonographic examination in the assessment of meniscal tears amounted to 85.4 % , 85.7 % , 67.3 % and 94.4 % , respectively . The statistical parameters were not statistically different in medial and lateral menisci . Age , sex , body mass index ( BMI ) , weight , physical activity , mechanism on injury , and time lapse from injury did not have a statistically significant impact on the usefulness of ultrasonography . The highest sensitivity ( > 90 % ) was obtained in medial menisci and in patients with a BMI > 25 . The highest specificity ( > 90 % ) was obtained in lateral menisci , in patients after twisting injuries , in sports injuries , and in recent injuries ( time lapse from the injury < 1 month ) . The positive predictive value ( PPV ) of sonographic examination was higher than 90 % only in recent injuries ( < 1 month ) , however , the negative predictive value of ultrasound is high , being less than 90 % in males with lesions of lateral menisci and in sequelae of sports injuries
Output:
| This meta- analysis indicates that 2-dimensional ultrasound is useful , and could be routinely used for estimating meniscal injuries in the human knee joint |
MS211418 | ***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 Mild cognitive impairment encompasses the clinical continuum between physiologic age-related cognitive changes and dementia . A variety of medications , including herbal preparations ( in particular Ginkgo biloba and Panax ginseng ) , have been advocated as treatments for cognitive impairment in the elderly . In this study , we investigated the effect of an already marketed dietary supplement ( Memo ® ) combining 750 mg of lyophilized royal jelly with st and ardized extracts of G. biloba 120 mg and P. ginseng 150 mg on Mini-Mental State Examination ( MMSE ) scores in patients with mild cognitive impairment . Methods Sixty-six subjects presenting with forgetfulness and satisfying the Diagnostic and Statistical Manual of Mental Disorders , 4th Edition , Text Revision ( DSM-IV-TR ) clinical criteria for mild cognitive impairment were r and omly divided into an experimental group treated with one Memo capsule before breakfast daily for 4 weeks and a control group who took placebo . The mean change in MMSE score from baseline and reported adverse effects were compared between the two groups . Results The mean change in MMSE score in the group treated with Memo for 4 weeks was significantly greater than in the control group ( + 2.07 versus + 0.13 , respectively ) by the Student ’s t-test ( t = 6.485 , P < 0.0001 ) . This was also true after adjusting for age as a covariate and educational level as a factor nested within the treatment groups in a general linear model ( analysis of covariance , F = 9.675 [ corrected model ] , P < 0.0001 ) . Conclusion This combined triple formula may be beneficial in treating the cognitive decline that occurs during the aging process as well as in the early phases of pathologic cognitive impairment typical of insidious-onset vascular dementia and in the early stages of Alzheimer ’s disease . Larger-sized studies with longer treatment duration s are needed to confirm this Background To examine the effect of multicomponent exercise program on memory function in older adults with mild cognitive impairment ( MCI ) , and identify biomarkers associated with improvement of cognitive functions . Methodology /Principal Findings Subjects were 100 older adults ( mean age , 75 years ) with MCI . The subjects were classified to an amnestic MCI group ( n = 50 ) with neuroimaging measures , and other MCI group ( n = 50 ) before the r and omization . Subjects in each group were r and omized to either a multicomponent exercise or an education control group using a ratio of 1∶1 . The exercise group exercised for 90 min/d , 2 d/wk , 40 times for 6 months . The exercise program was conducted under multitask conditions to stimulate attention and memory . The control group attended two education classes . A repeated- measures ANOVA revealed that no group × time interactions on the cognitive tests and brain atrophy in MCI patients . A sub- analysis of amnestic MCI patients for group × time interactions revealed that the exercise group exhibited significantly better Mini-Mental State Examination ( p = .04 ) and logical memory scores ( p = .04 ) , and reducing whole brain cortical atrophy ( p<.05 ) compared to the control group . Low total cholesterol levels before the intervention were associated with an improvement of logical memory scores ( p<.05 ) , and a higher level of brain-derived neurotrophic factor was significantly related to improved ADAS-cog scores ( p<.05 ) . Conclusions / Significance The results suggested that an exercise intervention is beneficial for improving logical memory and maintaining general cognitive function and reducing whole brain cortical atrophy in older adults with amnestic MCI . Low total cholesterol and higher brain-derived neurotrophic factor may predict improvement of cognitive functions in older adults with MCI . Further studies are required to determine the positive effects of exercise on cognitive function in older adults with MCI . Trial Registration UMIN-CTR UMIN000003662 ctr.cgi?function = brows&action = brows&type = summary & recptno = R000004436 & language = Objective : To examine the effects of aerobic exercise or vitamin B supplementation on cognitive function in older adults with mild cognitive impairment ( MCI ) . Design : R and omised placebo-controlled trial . Setting : General community . Participants : Community-dwelling adults aged 70–80 with MCI . Interventions : The 152 participants were r and omly assigned to two interventions : ( 1 ) a twice-weekly , group-based , moderate-intensity walking programme ( WP , n = 77 ) or a low-intensity placebo activity programme ( n = 75 ) for one year ; and ( 2 ) daily vitamin pill containing 5 mg folic acid , 0.4 mg vitamin B-12 , 50 mg vitamin B-6 ( FA/B12/B6 , n = 78 ) or placebo pill ( n = 74 ) for one year . Outcome measures : Cognitive function , measured with neuropsychological tests at baseline and after six and 12 months . Results : Median session attendance at the exercise programmes ( 25th–75th percentile ) was 63 % ( 2%–81 % ) and median compliance with taking pills ( 25th–75th percentile ) was 100 % ( 99%–100 % ) . Gender was an effect modifier . Intention-to-treat analysis revealed no main intervention effect for either intervention . In women in the WP , attention ( Stroop combination task ) improved by 0.3 seconds ( p = 0.04 ) and memory ( auditory verbal learning test ) by 0.04 words ( p = 0.06 ) with each percentage increase in session attendance . In men attending at least 75 % of the sessions , the WP improved memory ( β 1.5 ( 95 % CI : 0.1 to 3.0 ) words ) . Conclusion : The walking programme and /or FA/B12/B6 supplementation were not effective in improving cognition within one year . The walking programme , however , was efficacious in improving memory in men and memory and attention in women with better adherence . Trial registration : International St and ard R and omised Controlled Trial Number Register , 19227688 , http://www.controlled-trials.com/is rct OBJECTIVE To assess the effect of rivastigmine in patients with mild cognitive impairment ( MCI ) on the time to clinical diagnosis of Alzheimer 's disease ( AD ) and the rate of cognitive decline . METHODS The study was a double-blind , r and omised , placebo-controlled trial of up to 48 months . All patients had MCI operationally defined by having cognitive symptoms , a global clinical dementia rating stage of 0.5 , a score of less than 9 on the New York University delayed paragraph recall test , and by not meeting the diagnostic criteria for AD . Primary efficacy variables were time to clinical diagnosis of AD , and change in performance on a cognitive test battery . This study is registered with the US National Institutes of Health clinical trials data base ( Clinical Trials.gov ) , number NCT00000174 . FINDINGS Of 1018 study patients enrolled , 508 were r and omly assigned to rivastigmine and 510 to placebo ; 17.3 % of patients on rivastigmine and 21.4 % on placebo progressed to AD ( hazard ratio 0.85 [ 95 % CI 0.64 - 1.12 ] ; p=0.225 ) . There was no significant difference between the rivastigmine and placebo groups on the st and ardised Z score for the cognitive test battery measured as mean change from baseline to endpoint ( -0.10 [ 95 % CI -0.63 to 0.44 ] , p=0.726 ) . Serious adverse events were reported by 141 ( 27.9 % ) rivastigmine-treated patients and 155 ( 30.5 % ) patients on placebo ; adverse events of all types were reported by 483 ( 95.6 % ) rivastigmine-treated patients and 472 ( 92.7 % ) placebo-treated patients . The predominant adverse events were cholinergic : the frequencies of nausea , vomiting , diarrhoea , and dizziness were two to four times higher in the rivastigmine group than in the placebo group . INTERPRETATION There was no significant benefit of rivastigmine on the progression rate to AD or on cognitive function over 4 years . The overall rate of progression from MCI to AD in this r and omised clinical trial was much lower than predicted . Rivastigmine treatment was not associated with any significant safety concerns BACKGROUND Mild cognitive impairment is a transitional state between the cognitive changes of normal aging and early Alzheimer 's disease . METHODS In a double-blind study , we evaluated subjects with the amnestic subtype of mild cognitive impairment . Subjects were r and omly assigned to receive 2000 IU of vitamin E daily , 10 mg of donepezil daily , or placebo for three years . The primary outcome was clinical ly possible or probable Alzheimer 's disease ; secondary outcomes were cognition and function . RESULTS A total of 769 subjects were enrolled , and possible or probable Alzheimer 's disease developed in 212 . The overall rate of progression from mild cognitive impairment to Alzheimer 's disease was 16 percent per year . As compared with the placebo group , there were no significant differences in the probability of progression to Alzheimer 's disease in the vitamin E group ( hazard ratio , 1.02 ; 95 percent confidence interval , 0.74 to 1.41 ; P=0.91 ) or the donepezil group ( hazard ratio , 0.80 ; 95 percent confidence interval , 0.57 to 1.13 ; P=0.42 ) during the three years of treatment . Prespecified analyses of the treatment effects at 6-month intervals showed that as compared with the placebo group , the donepezil group had a reduced likelihood of progression to Alzheimer 's disease during the first 12 months of the study ( P=0.04 ) , a finding supported by the secondary outcome measures . Among carriers of one or more apolipoprotein E epsilon4 alleles , the benefit of donepezil was evident throughout the three-year follow-up . There were no significant differences in the rate of progression to Alzheimer 's disease between the vitamin E and placebo groups at any point , either among all patients or among apolipoprotein E epsilon4 carriers . CONCLUSIONS Vitamin E had no benefit in patients with mild cognitive impairment . Although donepezil therapy was associated with a lower rate of progression to Alzheimer 's disease during the first 12 months of treatment , the rate of progression to Alzheimer 's disease after three years was not lower among patients treated with donepezil than among those given placebo Background To examine the effects of a multicomponent exercise program on the cognitive function of older adults with amnestic mild cognitive impairment ( aMCI ) . Methods Design : Twelve months , r and omized controlled trial ; Setting : Community center in Japan ; Participants : Fifty older adults ( 27 men ) with aMCI ranging in age from 65 to 93 years ( mean age , 75 years ) ; Intervention : Subjects were r and omized into either a multicomponent exercise ( n = 25 ) or an education control group ( n = 25 ) . Subjects in the multicomponent exercise group exercised under the supervision of physiotherapists for 90 min/d , 2 d/wk , for a total of 80 times over 12 months . The exercises included aerobic exercises , muscle strength training , and postural balance retraining , and were conducted using multiple conditions to stimulate cognitive functions . Subjects in the control group attended three education classes regarding health during the 12-month period . Measurements were administered before , after the 6-month , and after the 12-month intervention period ; Measurements : The performance measures included the mini-mental state examination , logical memory subtest of the Wechsler memory scale-revised , digit symbol coding test , letter and categorical verbal fluency test , and the Stroop color word test . Results The mean adherence to the exercise program was 79.2 % . Improvements of cognitive function following multicomponent exercise were superior at treatment end ( group × time interactions for the mini-mental state examination ( P = 0.04 ) , logical memory of immediate recall ( P = 0.03 ) , and letter verbal fluency test ( P = 0.02 ) ) . The logical memory of delayed recall , digit symbol coding , and Stroop color word test showed main effects of time , although there were no group × time interactions . Conclusions This study indicates that exercise improves or supports , at least partly , cognitive performance in older adults with aMCI Rationale Epidemiological studies have suggested a beneficial effect of fish oil supplementation in halting the initial progression of Alzheimer ’s disease . However , it remains unclear whether fish oil affects cognitive function in older people with mild cognitive impairment ( MCI ) . Objectives This study investigated the effects of fish oil supplementation on cognitive function in elderly person with MCI . Methods This was a 12-month , r and omised , double-blind , placebo-controlled study using fish oil supplementation with concentrated docosahexaenoic acid ( DHA ) . Thirty six low-socioeconomic-status elderly subjects with MCI were r and omly assigned to receive either concentrated DHA fish oil ( n = 18 ) or placebo ( n = 18 ) capsules . The changes of memory , psychomotor speed , executive function and attention , and visual-constructive skills were assessed using cognitive
Output:
| INTERPRETATION Treatment of mild cognitive impairment with cholinesterase inhibitors showed no benefit when compared with a control group .
A small cognitive benefit was observed using behavioural therapies when compared with the control group .
However , the clinical significance of this small benefit remains uncertain . |
MS211419 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Abstract Objective : To evaluate the effects of secondary prevention clinics run by nurses in general practice on the health of patients with coronary heart disease . Design : R and omised controlled trial of clinics over one year with assessment by self completed postal question naires and audit of medical records at the start and end of the trial . Setting : R and om sample of 19 general practice s in northeast Scotl and . Subjects : 1173 patients ( 685 men and 488 women ) under 80 years with working diagnoses of coronary heart disease who did not have terminal illness or dementia and were not housebound . Intervention : Clinic staff promoted medical and lifestyle aspects of secondary prevention and offered regular follow up . Main outcome measures : Health status measured by the SF-36 question naire , chest pain by the angina type specification , and anxiety and depression by the hospital anxiety and depression scale . Use of health services before and during the study . Results : There were significant improvements in six of eight health status domains ( all functioning scales , pain , and general health ) among patients attending the clinic . Role limitations attributed to physical problems improved most ( adjusted difference 8.52 , 95 % confidence interval 4.16 to 12.9 ) . Fewer patients reported worsening chest pain ( odds ratio 0.59 , 95 % confidence interval 0.37 to 0.94 ) . There were no significant effects on anxiety or depression . Fewer intervention group patients required hospital admissions ( 0.64 , 0.48 to 0.86 ) , but general practitioner consultation rates did not alter . Conclusions : Within their first year secondary prevention clinics improved patients ' health and reduced hospital admissions . Key messages Nurse led clinics in general practice were used to promote secondary prevention to patients with coronary heart disease Within the first year the health of patients invited to the clinics improved Most benefit was in functional status , but chest pain improved too There was no effects on anxiety or depression There were significant reductions in hospital admissions in the first BACKGROUND Continence services in the UK have developed at different rates within differing care models , result ing in scattered and inconsistent services . Consequently , questions remain about the most cost-effective method of delivering these services . AIM To evaluate the impact of a new service led by a continence nurse practitioner compared with existing primary / secondary care provision for people with urinary incontinence and storage symptoms . DESIGN OF STUDY R and omised controlled trial with a 3- and 6-month follow-up in men and women ( n = 3746 ) aged 40 years and over living in private households ( intervention [ n = 2958 ] ; control [ n = 788 ] ) . SETTING Leicestershire and Rutl and , UK . METHOD The continence nurse practitioner intervention comprised a continence service provided by specially trained nurses delivering evidence -based interventions using predetermined care pathways . They delivered an 8-week primary intervention package that included advice on diet and fluids ; bladder training ; pelvic floor awareness and lifestyle advice . The st and ard care arm comprised access to existing primary care including GP and continence advisory services in the area . Outcome measures were recorded at 3 and 6 months post-r and omisation . RESULTS The percentage of individuals who improved ( with at least one symptom alleviated ) at 3 months was 59 % in the intervention group compared with 48 % in the st and ard care group ( difference of 11 % , 95 % CI = 7 to 16 ; P<0.001 ) The percentage of people reporting no symptoms or ' cured ' was 25 % in the intervention group and 15 % in the st and ard care group ( difference of 10 % , 95 % CI = 6 to 13 , P = 0.001 ) . At 6 months the difference was maintained . There was a significant difference in impact scores between the two groups at 3 and 6 months . CONCLUSIONS The continence nurse practitioner-led intervention reduced the symptoms of incontinence , frequency , urgency and nocturia at 3 and 6 months ; impact was reduced ; and satisfaction with the new service was high AIMS For children with stable asthma , to test non-inferiority of care provided by a hospital-based specialised asthma nurse versus a general practitioner ( GP ) or paediatrician . METHODS R and omised controlled trial evaluating st and ard care by a GP , paediatrician or an asthma nurse , with two-year follow-up . RESULTS 107 children were recruited , 45 from general practice and 62 from hospital . After two years , no significant differences between groups were found for airway responsiveness , FEV1 , asthma control , medication , school absence or parental work absence . In the general practice group there was a significantly lower frequency of regular review visits ( ' regular ' = at least one review per six months ) compared to the paediatrician and specialised asthma nurse group , both after one year [ 45.7 % versus 87.9 % and 94.3 % , respectively , ( p<0.0005 ) ] and after two years [ 26.5 % versus 87.9 % and 75.8 % , respectively , ( p<0.0005 ) ] . We found no significant differences in unplanned visits . In most cases the asthma nurse was able to provide care without consultation with the paediatrician . CONCLUSION The degree of disease control in stable childhood asthma managed by an asthma nurse is not inferior to traditional management by primary or secondary care physicians . The results also suggest that a lower review frequency does not detract from good disease control T h e increasing dem and for health-care services in the United States has been documented in several studies . The obvious solution , more manpower in all disciplines , is somewhat unrealistic . In all probability , the dem and for health services , as presently organized , can not be met at the rate that current education programs in the health professions can be exp and ed or replicated . ’ There is considerable discussion regarding the delegation of certain aspects of medical care to new types of health professionals as a means of increasing the quantity of services available . Another possibility is to define more adequately the roles of existing disciplines , on the assumption that they might work together more efficiently in providing interprofessional care for a larger number of patients . Although the hospital is the focus of medical care , the greatest dem and s for health services are made by vertical , rather than horizontal , patients . Inordinately large dem and s for ambulatory patient care are created by two groups of consumers . During the first few years of life , children must be seen frequently to provide optimal preventive care . At the other end of the life cycle of man , aging patients with chronic diseases accumulate . They too require frequent medical attention . Considering the “ excessive ” medical care needs of these two segments of the population , it is not surprising that they have been the subjects of experimentation in the delivery of services . Projects have been described in which nurses have assumed some of the functions of physicians engaged in the practice of obstetrics and pediatrics.2 - 4 With Objective To evaluate whether nurse run clinics in general practice improve secondary prevention in patients with coronary heart disease . Design R and omised controlled trial . Setting A r and om sample of 19 general practice s in northeast Scotl and . Patients 1173 patients ( 685 men and 488 women ) under 80 years with working diagnoses of coronary heart disease , but without terminal illness or dementia and not housebound . Intervention Nurse run clinics promoted medical and lifestyle aspects of secondary prevention and offered regular follow up . Main outcome measures Components of secondary prevention assessed at baseline and one year were : aspirin use ; blood pressure management ; lipid management ; physical activity ; dietary fat ; and smoking status . A cumulative score was generated by counting the number of appropriate components of secondary prevention for each patient . Results There were significant improvements in aspirin management ( odds ratio 3.22 , 95 % confidence interval 2.15 to 4.80 ) , blood pressure management ( 5.32 , 3.01 to 9.41 ) , lipid management ( 3.19 , 2.39 to 4.26 ) , physical activity ( 1.67 , 1.23 to 2.26 ) and diet ( 1.47 , 1.10 to 1.96 ) . There was no effect on smoking cessation ( 0.78 , 0.47 to 1.28 ) . Of six possible components of secondary prevention , the baseline mean was 3.27 . The adjusted mean improvement attributable to intervention was 0.55 of a component ( 0.44 to 0.67 ) . Improvement was found regardless of practice baseline performance . Conclusions Nurse run clinics proved practical to implement in general practice and effectively increased secondary prevention in coronary heart disease . Most patients gained at least one effective component of secondary prevention and , for them , future cardiovascular events and mortality could be reduced by up to a third Summary Background Robust evidence of the effectiveness of task shifting of antiretroviral therapy ( ART ) from doctors to other health workers is scarce . We aim ed to assess the effects on mortality , viral suppression , and other health outcomes and quality indicators of the Streamlining Tasks and Roles to Exp and Treatment and Care for HIV ( STRETCH ) programme , which provides educational outreach training of nurses to initiate and represcribe ART , and to de central ise care . Methods We undertook a pragmatic , parallel , cluster-r and omised trial in South Africa between Jan 28 , 2008 , and June 30 , 2010 . We r and omly assigned 31 primary -care ART clinics to implement the STRETCH programme ( intervention group ) or to continue with st and ard care ( control group ) . The ratio of r and omisation depended on how many clinics were in each of nine strata . Two cohorts were enrolled : eligible patients in cohort 1 were adults ( aged ≥16 years ) with CD4 counts of 350 cells per μL or less who were not receiving ART ; those in cohort 2 were adults who had already received ART for at least 6 months and were being treated at enrolment . The primary outcome in cohort 1 was time to death ( superiority analysis ) . The primary outcome in cohort 2 was the proportion with undetectable viral loads ( < 400 copies per mL ) 12 months after enrolment ( equivalence analysis , prespecified difference < 6 % ) . Patients and clinicians could not be masked to group assignment . The interim analysis was blind , but data analysts were not masked after the data base was locked for final analysis . Analyses were done by intention to treat . This trial is registered , number IS RCT N46836853 . Findings 5390 patients in cohort 1 and 3029 in cohort 2 were in the intervention group , and 3862 in cohort 1 and 3202 in cohort 2 were in the control group . Median follow-up was 16·3 months ( IQR 12·2–18·0 ) in cohort 1 and 18·0 months ( 18·0–18·0 ) in cohort 2 . In cohort 1 , 997 ( 20 % ) of 4943 patients analysed in the intervention group and 747 ( 19 % ) of 3862 in the control group with known vital status at the end of the trial had died . Time to death did not differ ( hazard ratio [ HR ] 0·94 , 95 % CI 0·76–1·15 ) . In a preplanned subgroup analysis of patients with baseline CD4 counts of 201–350 cells per μL , mortality was slightly lower in the intervention group than in the control group ( 0·73 , 0·54–1.00 ; p=0·052 ) , but it did not differ between groups in patients with baseline CD4 of 200 cells per μL or less ( 0·94 , 0·76–1·15 ; p=0·577 ) . In cohort 2 , viral load suppression 12 months after enrolment was equivalent in intervention ( 2156 [ 71 % ] of 3029 patients ) and control groups ( 2230 [ 70 % ] of 3202 ; risk difference 1·1 % , 95 % CI −2·4 to 4·6 ) . Interpretation Expansion of primary -care nurses ' roles to include ART initiation and represcription can be done safely , and improve health outcomes and quality of care , but might not reduce time to ART or mortality . Funding UK Medical Research Council , Development Cooperation Irel and , and Canadian International Development Agency Background Dyspepsia is a common disorder in the community , with many patients referred for diagnostic gastroscopy by their General Practitioner ( GP ) . The National Institute of Clinical Excellence ( NICE ) recommends follow-up after investigation for cost effective management , including lifestyle advice and drug use . An alternative strategy may be the use of a gastro-intestinal nurse practitioner ( GNP ) instead of the GP . The objective of this study is to compare the effectiveness and costs of systematic GNP led follow-up to usual care by GPs in dyspeptic patients following gastroscopy . Results Direct access adult dyspeptic patients referred for gastroscopy ; without serious pathology , were followed-up in a structured nurse-led outpatient clinic . Outcome measurement used to compare the two study cohorts ( GNP versus GP ) included Glasgow dyspepsia severity ( Gladys ) score , Health Status Short Form 12 ( SF12 ) , ulcer healing drug ( UHD ) use and costs . One hundred and seventy five patients were eligible after gastroscopy , 89 were r and omised to GNP follow-up and 86 to GP follow-up . Follow-up at 6 months was 81/89 ( 91 % ) in the GNP arm and 79/86 ( 92 % ) in the GP arm . On an intention to treat analysis , adjusted mean differences (
Output:
| Despite the method ological limitations and the varying nurses ' roles and competencies across studies , specially trained nurses can provide care that is at least as equivalent to care provided by physicians for the management of chronic diseases , in terms of process of care . |
MS211420 | ***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: Recurrence of hepatitis C after liver transplantation ( LT ) is the main cause of graft loss and retransplantation . Frequent liver biopsies are essential to follow-up hepatitis C virus (HCV)-induced liver damage . However , liver biopsy is an invasive and expensive procedure . We evaluated prospect ively the diagnostic accuracy of noninvasive measurement of liver stiffness ( by transient elastography ) to assess the severity of hepatitis C recurrence after LT . For this purpose , we included 124 HCV-infected liver transplant recipients who underwent 169 liver biopsies and 129 hepatic hemodynamic studies with determination of hepatic venous pressure gradient ( HVPG ) . Simultaneously , patients underwent measurement of liver stiffness . Liver fibrosis was mild ( F0-F1 ) in 96 cases ( 57 % ) and significant ( F2-F4 ) in 73 ( 43 % ) . HVPG was normal ( < 6 mm Hg ) in 69 cases ( 54 % ) and elevated ( > or=6 mm Hg ) in 60 ( 46 % ) . Using a liver stiffness cutoff value of 8.5 kilopascals , the sensitivity , specificity , negative predictive value , and positive predictive value for diagnosis of fibrosis > or = F2 were 90 % , 81 % , 79 % , and 92 % , respectively . The area under the curve ( AUC ) for diagnosis of fibrosis > or = F2 , > or = F3 and F4 were 0.90 , 0.93 , and 0.98 , respectively . There was a close direct correlation between liver stiffness and HVPG ( Pearson coefficient , 0.84 ; P < 0.001 ) and the AUC for diagnosis of portal hypertension ( HVPG > or=6 mm Hg ) was 0.93 . Importantly , none of the individuals with liver stiffness below the cutoff value had either bridging fibrosis ( F3 ) or cirrhosis ( F4 ) or significant portal hypertension ( HVPG > or=10 mm Hg ) . In conclusion , determination of liver stiffness is an extremely valuable tool to assess the severity of HCV recurrence after LT and in reducing the need of follow-up liver biopsies Background : Transient elastography ( FibroScan ) is a new , non-invasive , rapid , and reproducible method allowing evaluation of liver fibrosis by measurement of liver stiffness . In cirrhotic patients , liver stiffness measurements range from 12.5 to 75.5 kPa . However , the clinical relevance of these values is unknown . The aim of this prospect i ve study was to evaluate the accuracy of liver stiffness measurement for the detection of cirrhosis in patients with chronic liver disease . Methods : A total of 711 patients with chronic liver disease were studied . Aetiologies of chronic liver diseases were hepatitis C virus or hepatitis B virus infection , alcohol , non-alcoholic steatohepatitis , other , or a combination of the above aetiologies . Liver fibrosis was evaluated according to the METAVIR score . Results : Stiffness was significantly correlated with fibrosis stage ( r = 0.73 , p<0.0001 ) . Areas under the receiver operating characteristic curve ( 95 % confidence interval ) were 0.80 ( 0.75–0.84 ) for patients with significant fibrosis ( F>2 ) , 0.90 ( 0.86–0.93 ) for patients with severe fibrosis ( F3 ) , and 0.96 ( 0.94–0.98 ) for patients with cirrhosis . Using a cut off value of 17.6 kPa , patients with cirrhosis were detected with a positive predictive value and a negative predictive value ( NPV ) of 90 % . Liver stiffness was significantly correlated with clinical , biological , and morphological parameters of liver disease . With an NPV > 90 % , the cut off values for the presence of oesophageal varices stage 2/3 , cirrhosis Child-Pugh B or C , past history of ascites , hepatocellular carcinoma , and oesophageal bleeding were 27.5 , 37.5 , 49.1 , 53.7 , and 62.7 kPa , respectively . Conclusion : Transient elastography is a promising non-invasive method for detection of cirrhosis in patients with chronic liver disease . Its use for the follow up and management of these patients could be of great interest and should be evaluated further Background This prospect i ve study aim ed to assess the ability of transient elastography to identify histologic parameters , including steatosis , in asymptomatic healthy individuals such as potential liver donors , and to compare these findings with results in liver disease patients . Methods Forty-seven patients with abnormal liver function and /or hepatitis symptoms and 80 living related potential liver donors were consecutively enrolled , and liver biopsy and a Fibroscan test were performed in each subject . Histologic parameters were evaluated according to METAVIR scale by a single pathologist . Results In liver disease patients , stiffness was significantly correlated with fibrosis stage ( Spearman correlation coefficient , 0.700 ; P < 0.001 ) , and the optimal stiffness cutoff values for F ≥ 2 , F ≥ 3 , and F = 4 were 7.35 , 8.85 , and 15.1 kPa respectively . In potential liver donors , however , stiffness was not correlated with fibrosis ( 0.023 ; P = 0.851 ) . In the latter group , the area under the receiver-operating characteristics curve was 0.70 ( 95 % confidence interval , 0.58–0.81 ) , and the optimal stiffness cutoff value was 4.00 for F ≥ 2 , which was lower than that in liver disease patients . Steatosis was not correlated with stiffness ( 0.088 ; P = 0.463 ) in potential liver donors . Conclusions Transient elastography has limited value for detecting steatosis in asymptomatic healthy individuals , and the cutoff value for fibrosis should be reevaluated in these subjects Background The aim of this study was to assess the diagnostic performances of liver stiffness measurement ( LSM ) , ultrasonography ( US ) and their combined use in predicting the extent of hepatic fibrosis . Methods Consecutive patients with chronic hepatitis B ( HBV ) or hepatitis C virus ( HCV ) infections , with indications for liver biopsy , were prospect ively enrolled . LSM was performed on the same day as biopsy . US scores , including assessment of liver surface , liver parenchyma , intrahepatic vessels and spleen index , were used to assess the degree of hepatic fibrosis . The pathological findings were used as a reference st and ard and diagnostic accuracy was assessed and compared . Results Three-hundred and twenty patients , including 199 men and 121 women , with a mean age of 50.8 years , were analyzed . There were 214 ( 66.9 % ) HCV patients , 88 ( 27.5 % ) HBV patients and 18 ( 5.6 % ) patients with both HCV and HBV . LSM correlated significantly with the hepatic fibrosis ( F ) scores , necro-inflammatory activity and US scores in multivariate analysis . The diagnostic accuracy of LSM is significantly superior to US , and equal to combined LSM with US , in the prediction of all HCV-related fibrosis scores . The cut-off value of LSM is 6 kPa for diagnosing F > = 1 , with a positive predictive value of 91 % . Also , the cut-off value is 12 kPa for the prediction of cirrhosis , with a negative predictive value of 94 % . Conclusions LSM is useful for predicting hepatic fibrosis and excluding cirrhosis . A combination of LSM and US does not improve the accuracy in assessing hepatic fibrosis PURPOSE To prospect ively measure liver stiffness with real-time tissue elastography in patients with chronic hepatitis C and to compare the results with those of clinical assessment of fibrosis by using histologic stage as the reference st and ard . MATERIAL S AND METHODS All subjects gave informed consent , and the study was approved by the institutional ethics committee . Seventy hospitalized patients ( 46 men , 24 women ; mean age , 65.5 years ± 11.7 [ st and ard deviation ] ; age range , 33 - 87 years ) with chronic hepatitis C underwent real-time elastography between January 2009 and September 2009 . Elastography was performed at four liver locations by two independent observers . The elastic ratio ( ratio of the value in the intrahepatic venous small vessels divided by the value in the hepatic parenchyma ) was calculated and was compared with histologic fibrosis stage at liver biopsy . The elastic ratio and clinical fibrosis markers were assessed by using receiver operating characteristic ( ROC ) analysis . The differences between body site and observers were assessed with κ statistics and intraclass correlation coefficients ( ICCs ) . RESULTS Real-time tissue elastography cutoff values were 2.73 for F of 2 or greater , 3.25 for F of 3 or greater , and 3.93 for F of 4 . No site differences were observed ( κ = 0.835 , ICC = 0.966 ) , and the elastic ratio measurement was correlated between the two examiners ( r(2 ) = 0.869 , P < .0001 ) . The areas under the ROC curves for elastic ratio , hyaluronic acid , type IV collagen , aspartate aminotransferase-to-platelet ratio index , FibroIndex , Forns score , and Hepascore were 0.95 , 0.32 , 0.73 , 0.76 , 0.76 , 0.87 , and 0.70 , respectively ; the elastic ratio performed better than the serum fibrosis markers and other scores . CONCLUSION Real-time tissue elastography is not invasive and could be used to evaluate liver fibrosis in patients with chronic hepatitis C. SUPPLEMENTAL MATERIAL http://radiology.rsna.org/lookup/suppl/doi:10.1148/radiol.10100319/-/DC1 BACKGROUND & AIMS Both transient elastography ( TE ) and left lobe liver surface ( LLS ) ultrasound may non-invasively detect cirrhosis ( LC ) . We aim ed to examine the diagnostic value of these methods in patients with a suspicion but not a definite diagnosis of cirrhosis . METHODS We enrolled 90 patients with clinical suspicion of cirrhosis and a strong co-existing differential diagnosis requiring further invasive evaluation . They underwent hepatic venous pressure gradient ( HVPG ) measurement+/-transjugular liver biopsy , LLS and TE . Images of LLS were digitally post-processed to obtain a numerical value ( quantitative LLS , qLLS ) . TE<12kPa was considered to exclude LC , 18kPa diagnosed LC , and 12 - 18kPa indeterminate . Technical failures were considered ' indeterminate ' . Diagnosis of cirrhosis was confirmed by histology ( 84 % ) or by clinical data and HVPG10 mm Hg . Diagnostic accuracy was evaluated by positive and negative likelihood ratios ( + LR and -LR ) . RESULTS Cirrhosis was diagnosed in 44 patients . There were 14 technical failures with TE and 1 with LLS ( p=0.001 ) . TE and LLS had similar diagnostic accuracy but gave complementary information : TE was mildly more accurate than LLS to rule out LC ( -LR : 0.08 vs. 0.10 ) , while it was less accurate to rule it in ( + LR 5.05 vs. 11.15 ) . Their combination offered the best diagnostic performance ( + LR 9.15 ; -LR 0.06 ) . CONCLUSIONS LLS is more technically applicable than TE . In patients with clinical suspicion of cirrhosis , LLS is the best non-invasive method to diagnose cirrhosis , while TE is preferable to rule it out . The combination of both holds the best diagnostic accuracy The course of hepatitis C virus ( HCV ) infection carriers with normal/near-normal aminotransferases ( NALT ) is usually mild ; however , in a few , fibrosis progression occurs . We aim ed to verify whether monitoring by liver biopsy might be replaced by noninvasive methods and to identify factors associated with fibrosis progression in patients with persistently normal alanine aminotransferases . We studied 40 untreated HCV-RNA-positive subjects ( 22 male ; median age , 44 years ) , who underwent two liver biopsies , with a median interval of 78.5 months , during which alanine aminotransferase concentrations ( median number of determinations : 12 ) never exceeded 1.2 times the upper normal limit . Within 9 months from the second biopsy , they were tested by the shear elasticity probe ( Fibroscan ) and the artificial intelligence algorithm FibroTest . METAVIR fibrosis scores were analyzed in relationship to demographic , clinical , and viral parameters . Weighted kappa analysis was used to verify whether the results of noninvasive methods agreed with histology . Significant fibrosis ( > or = F2 ) , present at the first biopsy in only one patient ( 2.5 % ) , was observed at the second biopsy in 14 patients ( 35 % ) . At multivariate analysis
Output:
| The model was sensitive to the sensitivity and specificity of TE and the prevalence of fibrosis .
CONCLUSIONS TE is an accurate diagnostic method in patients with moderate fibrosis or cirrhosis .
TE is less effective but less expensive than liver biopsy . |
MS211421 | ***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 present study examined the impact of a brief version of an acceptance-based treatment ( acceptance and commitment therapy ; ACT ) that teaches patients to accept unavoidable private events ; to identify and focus on actions directed toward valued goals ; and to defuse from odd cognition , just noticing thoughts rather than treating them as either true or false . Eighty inpatient participants with positive psychotic symptoms were r and omly assigned to treatment as usual ( TAU ) or to 4 sessions of ACT plus TAU . ACT participants showed significantly higher symptom reporting and lower symptom believability and a rate of rehospitalization half that of TAU participants over a 4-month follow-up period . The same basic pattern of results was seen with all participant subgroups except delusional participants who denied symptoms Existing strategies for coping with food cravings are of unknown efficacy and rely on principles that have been shown to have paradoxical effects . The present study evaluated novel , acceptance-based strategies for coping with craving by r and omly assigning 48 overweight women to either an experimental psychological acceptance-oriented intervention or a st and ard cognitive re appraisal /distraction intervention . Participants were required to carry a box of sweets on their person for 72 h while abstaining from any consumption of sweets . Results suggested that the acceptance-based coping strategies result ed in lower cravings and reduced consumption , particularly for those who demonstrate greater susceptibility to the presence of food and report a tendency to engage in emotional eating OBJECTIVE R and omized comparisons of acceptance-based treatments with traditional cognitive behavioral therapy ( CBT ) for anxiety disorders are lacking . To address this gap , we compared acceptance and commitment therapy ( ACT ) to CBT for heterogeneous anxiety disorders . METHOD One hundred twenty-eight individuals ( 52 % female , mean age = 38 , 33 % minority ) with 1 or more DSM-IV anxiety disorders began treatment following r and omization to CBT or ACT ; both treatments included behavioral exposure . Assessment s at pre-treatment , post-treatment , and 6- and 12-month follow-up measured anxiety-specific ( principal disorder Clinical Severity Ratings [ CSRs ] , Anxiety Sensitivity Index , Penn State Worry Question naire , Fear Question naire avoidance ) and non-anxiety-specific ( Quality of Life Index [ QOLI ] , Acceptance and Action Question naire-16 [ AAQ ] ) outcomes . Treatment adherence , therapist competency ratings , treatment credibility , and co-occurring mood and anxiety disorders were investigated . RESULTS CBT and ACT improved similarly across all outcomes from pre- to post-treatment . During follow-up , ACT showed steeper linear CSR improvements than CBT ( p < .05 , d = 1.26 ) , and at 12-month follow-up , ACT showed lower CSRs than CBT among completers ( p < .05 , d = 1.10 ) . At 12-month follow-up , ACT reported higher AAQ than CBT ( p = .08 , d = 0.42 ; completers : p < .05 , d = 0.56 ) , whereas CBT reported higher QOLI than ACT ( p < .05 , d = 0.42 ) . Attrition and comorbidity improvements were similar ; ACT used more non- study psychotherapy at 6-month follow-up . Therapist adherence and competency were good ; treatment credibility was higher in CBT . CONCLUSIONS Overall improvement was similar between ACT and CBT , indicating that ACT is a highly viable treatment for anxiety disorders Objective To determine whether acceptance-based behavioral treatment ( ABT ) would result in greater weight loss than st and ard behavioral treatment ( SBT ) , and whether treatment effects were moderated by interventionist expertise or participants ’ susceptibility to eating cues . Recent research suggests that poor long-term weight control outcomes are due to lapses in adherence to weight control behaviors , and that adherence might be improved by enhancing SBT with acceptance-based behavioral strategies . Design and Methods Overweight participants ( n = 128 ) were r and omly assigned to 40 weeks of SBT or ABT . Results Both groups produced significant weight loss and , when administered by experts , weight loss was significantly higher in ABT than SBT at post-treatment ( 13.17 % v. 7.54 % ) and 6-month follow-up ( 10.98 % v. 4.83 % ) . Moreover , 64 % of those receiving ABT from experts ( v. 46 % for SBT ) maintained at least a 10 % weight loss by follow-up . Moderation analyses revealed a powerful advantage , at follow-up , of ABT over SBT in those potentially more susceptible to eating cues . For participants with greater baseline depression symptomology , weight loss at follow-up was 11.18 % in ABT vs. 4.63 % in SBT ; other comparisons were 10.51 % vs. 6.00 % ( emotional eating ) , 8.29 % v. 6.35 % ( disinhibition ) and 9.70 % v. 4.46 % ( responsivity to food cues ) . Mediation analyses produced partial support for theorized food-related psychological acceptance as a mechanism of action . Conclusions Results offer strong support for the incorporation of acceptance-based skills into behavioral weight loss treatments , particularly among those with greater levels of depression , responsivity to the food environment , disinhibition and emotional eating , and especially when interventions are provided by weight control experts . Trial Registration clinical trials.gov identifier : Ninety volunteers in a media organization were r and omly allocated to an Acceptance and Commitment Therapy ( ACT , n = 30 ) group that sought to enhance people 's ability to cope with work-related strain , an Innovation Promotion Program ( IPP , n = 30 ) that helped individuals to identify and then innovatively change causes of occupational strain , or a waitlist control group ( n = 30 ) . Both interventions lasted 9 hr , spread over 3 months . Improvements in mental health and work-related variables were found following both interventions . As hypothesized , changes in outcome variables in the ACT condition were mediated only by the acceptance of undesirable thoughts and feelings . In the IPP condition , outcome change was mediated only by attempts to modify stressors . Discussion focused on the importance of underst and ing the mechanisms underpinning change in occupational stress management interventions Patients in a low-income community health center with Type 2 diabetes ( N = 81 ) taking a one-day education workshop as part of their diabetes medical management were r and omly assigned either to education alone or to a combination of education and acceptance and commitment therapy ( ACT ) . Both groups were taught how to manage their diabetes , but those in the ACT condition also learned to apply acceptance and mindfulness skills to difficult diabetes-related thoughts and feelings . Compared with patients who received education alone , after 3 months those in the ACT condition were more likely to use these coping strategies , to report better diabetes self-care , and to have glycated hemoglobin ( HbA-sub(1C ) ) values in the target range . Mediational analyses indicated that changes in acceptance coping and self-management behavior mediated the impact of treatment on changes in HbA-sub(1C ) Cognitive behavior therapy ( CBT ) has been demonstrated in a number of r and omized controlled trials to be efficacious as an adjunctive treatment for psychotic disorders . Emerging evidence suggests the usefulness of CBT interventions that incorporate acceptance/mindfulness-based approaches for this population . The current study extended previous research by Bach and Hayes ( 2002 . The use of Acceptance and Commitment Therapy to prevent the rehospitalization of psychotic patients : A r and omized controlled trial . Journal of Consulting and Clinical Psychology , 70 , 1129 - 1139 ) using Acceptance and Commitment Therapy ( ACT ) in the treatment of psychosis . Psychiatric in patients with psychotic symptoms were r and omly assigned to enhanced treatment as usual ( ETAU ) or ETAU plus individual sessions of ACT . At discharge from the hospital , results suggested short-term advantages in the ACT group in affective symptoms , overall improvement , social impairment , and distress associated with hallucinations . In addition , more participants in the ACT condition reached clinical ly significant symptom improvement at discharge . Although 4-month rehospitalization rates were lower in the ACT group , these differences did not reach statistical significance . Decreases in the believability of hallucinations during treatment were observed only in the ACT condition , and change in believability was strongly associated with change in distress after controlling for change in the frequency of hallucinations . Results are interpreted as largely consistent with the findings of Bach and Hayes and warrant further investigations with larger sample In this comparative intervention study , 107 working individuals with above average levels of distress were r and omly assigned to one of three conditions : acceptance and commitment therapy ( ACT ; n = 37 ) ; stress inoculation training ( SIT ; n = 37 ) ; or a waitlist control group ( n = 33 ) . The interventions were delivered to small groups in the workplace via two half-day training sessions . ACT and SIT were found to be equally effective in reducing psychological distress across a three month assessment period . Mediation analysis indicated that the beneficial impact of ACT on mental health result ed from an increase in psychological flexibility rather than from a change in dysfunctional cognitive content . Contrary to hypothesis , a reduction in dysfunctional cognitions did not mediate change in the SIT condition . Results suggest that the worksite may offer a useful , yet underutilised , arena for testing cognitive-behavioural theories of change Borderline personality disorder ( BPD ) and deliberate self-harm are clinical ly important conditions for which additional economically and clinical ly feasible interventions are needed . Literature on both the emotion regulating and experientially avoidant function of self-harm and the role of emotional dysfunction in BPD provided the rationale for developing a group intervention targeting emotion dysregulation among self-harming women with BPD . This study provides preliminary data on the efficacy of this new , 14-week , emotion regulation group intervention , design ed to teach self-harming women with BPD more adaptive ways of responding to their emotions so as to reduce the frequency of their self-harm behavior . Participants were matched on level of emotion dysregulation and lifetime frequency of self-harm and r and omly assigned to receive this group in addition to their current outpatient therapy ( N = 12 ) , or to continue with their current outpatient therapy alone for 14 weeks ( N = 10 ) . Results indicate that the group intervention had positive effects on self-harm , emotion dysregulation , experiential avoidance , and BPD-specific symptoms , as well as symptoms of depression , anxiety , and stress . Participants in the group treatment condition evidence d significant changes over time on all measures , and reached normative levels of functioning on most . While these preliminary results are promising , the study 's limitations require their replication in a larger-scale r and omized controlled trial OBJECTIVE To examine whether an empirically and theoretically derived treatment combining mindfulness- and acceptance-based strategies with behavioral approaches would improve outcomes in generalized anxiety disorder ( GAD ) over an empirically supported treatment . METHOD This trial r and omized 81 individuals ( 65.4 % female , 80.2 % identified as White , average age 32.92 ) diagnosed with GAD to receive 16 sessions of either an acceptance-based behavior therapy ( ABBT ) or applied relaxation ( AR ) . Assessment s at pretreatment , posttreatment , and 6-month follow-up included the following primary outcome measures : GAD clinician severity rating , Structured Interview Guide for the Hamilton Anxiety Rating Scale , Penn State Worry Question naire , Depression Anxiety Stress Scale , and the State-Trait Anxiety Inventory . Secondary outcomes included the Beck Depression Inventory-II , Quality of Life Inventory , and number of comorbid diagnoses . RESULTS Mixed effect regression models showed significant , large effects for time for all primary outcome measures ( ds = 1.27 to 1.61 ) but nonsignificant , small effects for condition and Condition × Time ( ds = 0.002 to 0.20 ) , indicating that clients in the 2 treatments improved comparably over treatment . For secondary outcomes , time was significant ( ds = 0.74 to 1.38 ) , but condition and Condition × Time effects were not ( ds = 0.004 to 0.31 ) . No significant differences emerged over follow-up ( ds = 0.03 to 0.39 ) , indicating maintenance of gains . Between 63.3 and 80.0 % of clients in ABBT and 60.6 and 78.8 % of clients in AR experienced clinical ly significant change across 5 calculations of change at posttreatment and follow-up . CONCLUSION ABBT is a viable alternative for treating GAD . ( PsycINFO Data base Record ( c ) 2013 APA , all rights reserved ) OBJECTIVE Web-based smoking cessation interventions have high reach , but low effectiveness . To address this problem , we conducted a pilot r and omized controlled trial of the first web-based acceptance and commitment therapy ( ACT ) intervention for smoking cessation . The aims were to determine design feasibility , user receptivity , effect on 30-day point prevalence quit rate at 3 months post-r and omization , and mediation by ACT theory-based processes of acceptance . METHODS Adult participants were recruited nationally into the double-blind r and omized controlled pilot trial ( N = 222 ) , which compared web-based ACT for smoking cessation ( WebQuit.org ) with the National Cancer Institute
Output:
| An evidence -base evaluation showed that ACT is not yet well-established for any disorder .
It is probably efficacious for chronic pain and tinnitus , possibly efficacious for depression , psychotic symptoms , OCD , mixed anxiety , drug abuse , and stress at work , and experimental for the remaining disorders |
MS211422 | ***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 purpose of this study was to investigate the effect of resistance training on resting blood pressure and heart rate variability in elderly postmenopausal women . 29 untrained , non-hypertensive elderly women were r and omly assigned to 2 groups : an intervention group ( n=15 , 65.5±5.0 years , 57.3±6.5 kg , 156.7±5.1 cm ) that underwent a supervised resistance training program ( 8 exercises , 2 sets , 10 - 15 repetitions , 3 times/week ) or a control group ( n=14 , 66.2±4.1 years , 61.1±11.7 kg , 157.5±7.1 cm ) that participated in a supervised stretching program ( 25 - 30 min/session , 2 times/week ) . Resting auscultatory blood pressure , heart rate variability , evaluated from short recordings in a seated position , and maximal dynamic strength ( 1-RM test ) were measured at baseline and after 12 weeks . A group x time ANOVA revealed that muscular strength increased significantly in the resistance training group ( + 10.2 % for bench press and + 12.7 % for leg extension , P<0.05 ) . Systolic blood pressure was reduced significantly in the resistance training group from pre- to post-intervention period ( - 5 mmHg ; P<0.05 ) , while no significant effect was noted for diastolic blood pressure and heart rate variability indexes ( P>0.05 ) . None of these variables changed in the control group throughout the study . In conclusion , a supervised resistance training program improved muscular strength and reduced systolic blood pressure without affecting diastolic blood pressure and heart rate variability in elderly postmenopausal women PURPOSE The aim of the present study was to evaluate the effects of 16 wk of resistance training ( RT ) , endurance training ( ET ) , and concurrent training ( CT ) on inflammatory markers , C-reactive protein ( CRP ) , and functional capacity in sedentary middle-age men . METHODS Healthy subjects were r and omized into RT ( n = 11 ) , ET ( n = 12 ) , CT ( n = 11 ) , and a control group ( n = 13 ) . The subjects performed three weekly sessions lasting about 60 min for 16 wk . Maximal strength was tested in bench press and leg press . The peak oxygen uptake ( VO2peak ) was measured in an incremental exercise test . Plasma tumor necrosis factor-α ( TNF-α ) , interleukin-6 ( IL-6 ) , and CRP levels were determined by an enzyme-linked immunosorbent assay . RESULTS Maximal strength was increased after 16 wk , with no differences between RT and CT . VO2peak increased in ET and CT comparing before and after training . There were no significant differences in TNF-α , IL-6 , and CRP comparing before and after training . CONCLUSIONS Sixteen weeks of RT , ET , or CT in middle-age healthy men has not affected low and moderate IL-6 , TNF-α , and CRP levels . CT performed in the same weekly frequency and session duration of ET and RT was effective in increasing both maximal strength and VO2peak , in addition to improvements in lipid profile Purpose Resistance exercise is promoted in older adults for its ability to improve muscle mass , strength and , hence , in reducing falls . However , its effects on blood lipids and CVD risk are less well established , particularly in this age group . This study aim ed to investigate whether a 1-year resistance exercise program improves lipid profile and chylomicron concentration in older men . Methods Participants were r and omised to either three , 1 h resistance training sessions per week ( RE ) or an active control group [ asked to undertake three 30 min walking sessions per week ( AC ) ] . Fasting blood sample s were collected at 0 , 6 , and 12 months for determination of lipid profile and glycaemic control . Diet , morphological and activity data were also collected at these time points . Results Following 12 months , the RE intervention group had greater improvements in cholesterol profile ; LDL-cholesterol concentration significantly decreased by 0.2 ( 0.2 ) mM [ mean ( SEM ) ] compared to control ( P < 0.05 ) . The RE group also exhibited a significant increase in lean body mass of 0.9 ( 1.3 ) kg after 12 months compared to the AC group ( P < 0.05 ) . There was no treatment or time effect on other anthropometric measures or fasting triacylglycerol , glucose , insulin or chylomicron concentrations . Conclusion The observed improvements in lean body mass and cholesterol profile promote the implementation of a resistance exercise intervention in this population This study aim ed at examined the effect of a 12-week whole body vibration ( WBV ) training program on leg blood flow and body composition in people with type 2 diabetes mellitus ( T2DM ) . Forty participants were r and omly assigned to either a WBV training group ( WBV ; n = 20 ) or usual-care control group ( CON ; n = 20 ) . Body composition [ waist circumference , waist to hip ratio ( WHR ) , weight , height , percentage of body fat and fat-free mass ] , heart rate , and blood flow [ femoral artery diameter , maximum systolic velocity , maximum diastolic velocity ( DV ) , time averaged mean , pulsatility index and resistance index ( RI ) , mean velocity ( Vmed ) , and peak blood velocities ( PBV ) ] were assessed at baseline and after 12 weeks . There were significant increases in the blood flow ( p = 0.046 ) , Vmed ( p = 0.050 ) , and DV ( p = 0.037 ) after WBV compared with CON . Within-group analysis showed significant differences in Vmed , PBV , and DV in the WBV group . Significant decreases after the intervention in weight ( p < 0.001 ) , waist circumference ( p < 0.001 ) , WHR ( p < 0.05 ) , and body fat ( p < 0.05 ) were also found , with significant between-groups decreases in all these outcomes in the WBV group . Significant correlations existed between changes in percent body fat and blood flow [ blood flow ( −0.761 ) , Vmed ( −0.607 ) , PBV ( −0.677 ) , and RI ( 0.0510 ) ] . WBV training can be considered an effective means to increase leg blood flow and to reduce adiposity in patients with T2DM 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 — In coronary artery disease , exercise training ( ET ) is associated with an improvement in endothelial function , but little is known about the relative effect of different types of training . The purpose of this study was to prospect ively evaluate the effect of different types of ET on endothelial function in 209 patients after a first recent acute myocardial infa rct ion . Methods and Results — Endothelial function was evaluated before and after 4 weeks of different types of ET and after 1 month of detraining by measuring flow-mediated dilation and von Willebr and factor levels at baseline and after ET . Patients were r and omized into 4 groups : group 1 , aerobic ET ( n=52 ) ; group 2 , resistance training ( n=54 ) ; group 3 , resistance plus aerobic training ( n=53 ) ; and group 4 , no training ( n=50 ) . At baseline , flow-mediated dilation was 4.5±2.6 % in group 1 , 4.01±1.6 % in group 2 , 4.4±4 % in group 3 , and 4.3±2.3 % in group 4 ( P = NS ) . After ET , flow-mediated dilation increased to 9.9±2.5 % in group 1 , 10.1±2.6 % in group 2 , and 10.8±3 % in group 3 ( P<0.01 versus baseline for all groups ) ; it also increased in group 4 but to a much lesser extent ( to 5.1±2.5 % ; P<0.01 versus trained groups ) . The von Willebr and factor level after ET decreased by 16 % ( P<0.01 ) similarly in groups 1 , 2 , and 3 but remained unchanged in group 4 . Detraining returned flow-mediated dilation to baseline levels ( P<0.01 versus posttraining ) . Conclusion — In patients with recent acute myocardial infa rct ion , ET was associated with improved endothelial function independently of the type of training , but this effect disappeared after 1 month of detraining BACKGROUND We aim ed to evaluate whether reduced cardiovascular fitness has a direct or indirect effect for the development of cardiovascular disease . METHODS We investigated 15,595 men and women who were annually screened in a tertiary medical center . All subjects were free of ischemic heart disease and had completed maximal exercise stress test according to the Bruce protocol at their first visit . Fitness was categorized into age- and sex-specific quintiles ( Q ) according to Bruce protocol treadmill time with Q1 as lowest fitness . Subjects were categorized at baseline into 3 groups : low fitness ( Q1 ) , moderate fitness ( Q2-Q4 ) , and high fitness ( Q5 ) . The primary end point of the current analysis was the development of a first cardiovascular event during follow-up . RESULTS Mean age of study patients was 48 ± 10 years , and 73 % were men . A total of 679 events occurred during 92,092 person-years of follow-up . Kaplan-Meier survival analysis showed that the cumulative probability of cardiovascular events at 6 years was significantly higher among subjects with low fitness ( P < .001 ) . Low fitness was associated with known cardiovascular risk factors , including hypercholesterolemia ( odds ratio [ OR ] 1.58 , 95 % CI 1.31 - 1.89 ) , diabetes mellitus ( OR 2.32 , 95 % CI 1.58 - 3.41 ) , and obesity ( OR 10.46 , 95 % CI 8.43 - 12.98 ) . The effect of low fitness on cardiovascular events was no longer significant when including diabetes mellitus , hypercholesterolemia , and obesity as mediators ( hazard ratio 0.99 , 95 % CI 0.82 - 1.19 ) . CONCLUSIONS The association between cardiovascular fitness and adverse cardiovascular outcomes may be modulated through traditional cardiovascular risk factors . These findings need to be further vali date d in prospect i ve clinical trials Background This pilot study examined long-term pulse wave velocity ( PWV ) and peak oxygen uptake ( VO2peak ) outcomes following a 12-week moderate-intensity aerobic or resistance training programme in kidney transplant recipients . Method Single-blind , bi-centre r and omised controlled parallel trial . 42 out of 60 participants completed a 9-month follow-up assessment ( Aerobic training = 12 , Resistance training = 10 and usual care = 20 ) . Participants completed 12 weeks of twice-weekly supervised aerobic or resistance training . Following the 12-week exercise intervention , participants were transitioned to self-managed community exercise activity using motivational interviewing techniques . Usual care participants received usual encouragement for physical activity during routine clinical appointments in the transplant clinic . PWV , VO2peak , blood pressure and body weight were assessed at 12 weeks and 12 months , and compared to baseline . Results ANCOVA analysis , covarying for baseline values , age , and length of time on dialysis pre-transplantation , revealed a significant mean between-group difference in PWV of -1.30 m/sec ( 95%CI -2.44 to -0.17 , p = 0.03 ) between resistance training and usual care groups . When comparing the aerobic training and usual care groups at 9-month follow-up , there was a mean difference of -1.05 m/sec ( 95%CI -2.11 to 0.017 , p = 0.05 ) . A significant mean between-group difference in relative VO2peak values of 2.2 ml/kg/min ( 95 % CI 0.37 to 4.03 , p = 0.02 ) when comparing aerobic training with usual care was revealed . There was no significant between group differences in body weight or blood pressure . There were no significant adverse effects associated with the interventions . Conclusions Significant between-group differences in 9-month follow-up PWV existed when comparing resistance exercise intervention with usual care . A long-term between-group difference in VO2peak was only evident when comparing aerobic intervention with usual care . This pilot study , with a small sample size , did not aim to eluci date mechanistic mediators related to the exercise interventions . It is however suggested that a motivational interviewing approach , combined with appropriate transition to community training programmes , could maintain the improvements gained from the 12-week exercise interventions and further research in this area is therefore warranted . Trial registration study number : IS RCT N43892586 OBJECTIVE --To determine the effectiveness of group- vs home-based exercise training of higher and lower intensities among healthy , sedentary older adults . DESIGN --Year-long r and omized , controlled trial comparing ( 1 ) higher-intensity group-based exercise training ; ( 2 ) higher-intensity home-based exercise training ; ( 3 ) lower-intensity home-based exercise training ; or ( 4
Output:
| The effects were greater in those with elevated cardiometabolic risk or disease compared with younger healthy adults .
There was limited evidence of adverse events .
CONCLUSIONS RET may be effective for inducing improvements in cardio metabolic health outcomes in healthy adults and those with an adverse cardio metabolic risk profile . |
MS211423 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Therapeutic hypothermia ( TH ) improves the outcomes of cardiac arrest ( CA ) survivors . The aim of this study was to evaluate retrospectively the efficacy and safety of an immediate prehospital cooling procedure implemented just after the return of spontaneous circulation with a prehospital setting . During 30 months , the case records of comatose survivors of out-of-hospital CA presumably due to a cardiac disease were studied . A routine protocol of immediate postresuscitation cooling had been tested by an emergency team , which consisted of an infusion of large-volume , ice-cold intravenous saline . We decided to assess the efficacy and tolerance of this procedure . A total of 99 patients were studied ; 22 were treated with prehospital TH , and 77 consecutive patients treated with prehospital st and ard resuscitation served as controls . For all patients , TH was maintained for 12 to 24 hours . The demographic , clinical , and biological characteristics of the patients were similar in the 2 groups . The rate of patients with a body temperature of less than 35 degrees C upon admission was 41 % in the cooling group and 18 % in the control group . Rapid infusion of fluid was not associated with pulmonary edema . After 1 year of follow-up , 6 ( 27 % ) of 22 patients in the cooling group and 30 ( 39 % ) of 77 patients in the control group had a good outcome . Our preliminary observation suggests that in comatose survivors of CA , prehospital TH with infusion of large-volume , ice-cold intravenous saline is feasible and can be used safely by mobile emergency and intensive care units AIM The aim of this study is to evaluate the extent of myocardial injury by cardiac biomarkers during prolonged targeted temperature management of 24 hours vs 48 hours after out-of-hospital cardiac arrest . METHODS This r and omized Sc and inavian multicenter study compares the extent of myocardial injury quantified by area under the curve ( AUC ) of cardiac biomarkers during prolonged targeted temperature management at 33 ° C ± 1 ° C of 24 hours and 48 hours , respectively . Through a period of 2.5 years , 161 comatose out-of-hospital cardiac arrest patients were r and omized to targeted temperature management for 24 hours ( n = 77 ) or 48 hours ( n = 84 ) . The AUC was calculated using both high-sensitivity cardiac troponin T ( hs-cTnTAUC ) and creatine kinase-myocardial b and ( CK-MBAUC ) that were based upon measurements of these biomarkers every 6 hours upon admission until 96 hours after reaching target temperature . RESULTS The median hs-cTnTAUC of 33,827 ng/L/h ( interquartile range [ IQR ] 11,366 - 117,690 ) of targeted temperature management at 24 hours did not differ significantly from that of 28,973 ng/L/h ( IQR 10,656 - 163,655 ) at 48 hours . In contrast , the median CK-MBAUC of 1829 μg/L/h ( IQR 800 - 6799 ) during targeted temperature management at 24 hours was significantly lower than that of 2428 μg/L/h ( IQR 1163 - 10,906 ) within targeted temperature management at 48 hours , P < .05 . CONCLUSION This study of comatose out-of-hospital cardiac arrest survivors showed no difference between the extents of myocardial injury estimated by hs-cTnTAUC of prolonged targeted temperature management of 48 hours vs 24 hours , although the CK-MBAUC was significantly higher during 48 hours vs 24 hours . Hence , it seems unlikely that the duration of targeted temperature management has a beneficial effect on the extent of myocardial injury after out-of-hospital cardiac arrest , and may even have a worsening effect Objectives : Atrial fibrillation has been associated with increased mortality in the general population and mixed population s of critical ill . Atrial fibrillation can also affect patients during post – cardiac arrest care . We sought to assess the prognostic implication s of atrial fibrillation following out-of-hospital cardiac arrest , including relation to the level of targeted temperature management . Design : A post hoc analysis of a prospect i ve r and omized trial . Setting : Thirty-six ICUs . Patients : We included 897 ( 96 % ) of the 939 comatose out-of-hospital cardiac arrest survivors from the targeted temperature management trial ( year , 2010–2013 ) with data on heart rhythm on day 2 . Interventions : Targeted temperature management at 33 ° C or 36 ° C . Measurements and Main Results : Endpoints included cumulative proportion of atrial fibrillation following out-of-hospital cardiac arrest and 180-day all-cause mortality and specific death causes stratified by atrial fibrillation . Atrial fibrillation on day 2 was used as primary endpoint analyses to exclude effects of short-term atrial fibrillation related to resuscitation and initial management . The cumulative proportions of atrial fibrillation were 15 % and 11 % on days 1 and 2 , respectively . Forty-three percent of patients with initial atrial fibrillation the first day were reported with sinus rhythm on day 2 . No difference was found between the groups treated with targeted temperature management at 33 ° C and 36 ° C . Patients affected by atrial fibrillation had significantly higher 180-day mortality ( atrial fibrillation : 66 % vs no-atrial fibrillation : 43 % ; plogrank < 0.0001 and unadjusted hazard ratio , 1.75 [ 1.35–2.30 ] ; p < 0.0001 ) . The association between atrial fibrillation and higher mortality remained significant ( adjusted hazard ratio , 1.34 [ 1.01–1.79 ] ; p < 0.05 ) adjusted for potential confounders . Atrial fibrillation was independently associated with increased risk of cardiovascular death and multiple-organ failure ( adjusted hazard ratio , 2.07 [ 1.39–3.09 ] ; p < 0.001 ) , whereas no association with higher risk of death from cerebral causes was found . Conclusions : Atrial fibrillation was independently associated with higher mortality , primarily driven by cardiovascular causes and multiple-organ failure , and may thus identify a vulnerable sub population . Whether treatment to prevent atrial fibrillation is associated with an improved prognosis remains to be established BACKGROUND Cardiac arrest with widespread cerebral ischemia frequently leads to severe neurologic impairment . We studied whether mild systemic hypothermia increases the rate of neurologic recovery after resuscitation from cardiac arrest due to ventricular fibrillation . METHODS In this multicenter trial with blinded assessment of the outcome , patients who had been resuscitated after cardiac arrest due to ventricular fibrillation were r and omly assigned to undergo therapeutic hypothermia ( target temperature , 32 degrees C to 34 degrees C , measured in the bladder ) over a period of 24 hours or to receive st and ard treatment with normothermia . The primary end point was a favorable neurologic outcome within six months after cardiac arrest ; secondary end points were mortality within six months and the rate of complications within seven days . RESULTS Seventy-five of the 136 patients in the hypothermia group for whom data were available ( 55 percent ) had a favorable neurologic outcome ( cerebral-performance category , 1 [ good recovery ] or 2 [ moderate disability ] ) , as compared with 54 of 137 ( 39 percent ) in the normothermia group ( risk ratio , 1.40 ; 95 percent confidence interval , 1.08 to 1.81 ) . Mortality at six months was 41 percent in the hypothermia group ( 56 of 137 patients died ) , as compared with 55 percent in the normothermia group ( 76 of 138 patients ; risk ratio , 0.74 ; 95 percent confidence interval , 0.58 to 0.95 ) . The complication rate did not differ significantly between the two groups . CONCLUSIONS In patients who have been successfully resuscitated after cardiac arrest due to ventricular fibrillation , therapeutic mild hypothermia increased the rate of a favorable neurologic outcome and reduced mortality PURPOSE Life threatening arrhythmias are increasingly frequent with lower body temperature . While targeted temperature management ( TTM ) with mild hypothermia following out-of-hospital cardiac arrest ( OHCA ) is generally considered safe and has been suggested as a potential antiarrhythmic add-on therapy , it is unknown whether the level of TTM affects the burden of ventricular ectopic activity . We sought to assess the ventricular ectopic burden between patients treated with TTM at 33 ° C or 36 ° C for 24h . METHODS Continuous 12-lead digital Holter electrocardiograms performed during the intervention were analyzed blinded to treatment allocation in 115 comatose OHCA-survivors from a single center of the TTM-trial . The main study showed no difference with regards to mortality . RESULTS Fifty-eight patients were r and omized to 33 ° C and 57 to 36 ° C . Cardiac arrest characteristics were similar between the groups . The number of isolated ventricular ectopic beats ( VEB ) per hour was similar at the beginning of the maintenance phase of TTM and decreased over time in both groups ( both ptime<0.001 ) . The reduction in VEB per hour was significantly affected by target temperature ( pinteraction<0.0001 ) , with fewer VEB in the 36 ° C-group . The total number of isolated , couplets and number of runs of VEB per hour showed similar results , with less ventricular ectopic activity in the 36 ° C-group ( pinteraction<0.0001 ) . Increasing numbers of pre-hospital defibrillations ( log2 ) were associated with a 46 % increase in ventricular ectopic activity ( p<0.01 ) , adjusted for potential confounders . CONCLUSIONS Ventricular ectopic activity was reduced in comatose OHCA-survivors treated with TTM at 36 ° C compared to 33 ° C . Higher numbers of pre-hospital defibrillations were associated with higher incidence of ventricular ectopic activity Background and Purpose — Cognitive deficits are common in survivors of cardiac arrest ( CA ) . The aim of this study was to examine the effect of therapeutic hypothermia after CA on cognitive functioning and neurophysiological outcome . Methods — A cohort of 70 consecutive adult patients resuscitated from out-of-hospital ventricular fibrillation CA were r and omly assigned to therapeutic hypothermia of 33 ° C for 24 hours accomplished by external cooling or normothermia . Neuropsychological examination was performed to 45 of the 47 conscious survivors of CA ( 27 in hypothermia and 18 in normothermia group ) 3 months after the incident . Quantitative electroencephalography ( Q-EEG ) and auditory P300 event-related potentials were studied on 42 patients at the same time point . Results — There were no differences between the 2 treatment groups in demographic variables , depression , or delays related to the resuscitation . No differences were found in any of the cognitive functions between the 2 groups . 67 % of patients in hypothermia and 44 % patients in normothermia group were cognitively intact or had only very mild impairment . Severe cognitive deficits were found in 15 % and 28 % of patients , respectively . All Q-EEG parameters were better in the hypothermia-treated group , but the differences did not reach statistical significance . The amplitude of P300 potential was significantly higher in hypothermia-reated group . Conclusions — The use of therapeutic hypothermia was not associated with cognitive decline or neurophysiological deficits after out-of-hospital CA AIM Survivors of out-of-hospital cardiac arrest ( OHCA ) may experience psychological distress but the actual prevalence is unknown . The aim of this study was to investigate anxiety and depression within a large cohort of OHCA-survivors . METHODS OHCA-survivors r and omized to targeted temperature of 33 ° C or 36 ° C within the Target Temperature Management trial ( TTM-trial ) attended a follow-up after 6 months that included the question naire Hospital Anxiety and Depression Scale ( HADS ) . A control group with ST-elevation myocardial infa rct ion ( STEMI ) completed the same follow-up . Correlations to variables assumed to be associated with anxiety and depression in OHCA-survivors were tested . RESULTS At follow-up 278 OHCA-survivors and 119 STEMI-controls completed the HADS where 24 % of OHCA-survivors ( 28 % in 33 ° C group/22 % in 36 ° C group , p=0.83 ) and 19 % of the STEMI-controls reported symptoms of anxiety ( OR 1.32 ; 95 % CI ( 0.78 - 2.25 ) , p=0.30 ) . Depressive symptoms were reported by 13 % of OHCA-survivors ( equal in both intervention groups , p=0.96 ) and 8 % of STEMI-controls ( OR 1.76 ; 95 % CI (
Output:
| There is a considerable incidence of side effects attributed to the procedure , e.g. , from life‐threatening ventricular arrhythmias to self‐limited consequences .
Most studies analyzed in this systematic review indicated that the procedure of TH has not caused severe adverse effects leading to significant alterations in the outcomes following resuscitation from OHCA . |
MS211424 | ***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 presence of tibial bone tunnel enlargement after surgical reconstruction of the anterior cruciate ligament using quadruple graft of the flexor tendons and correlate the functional results in their presence . Methods : The studied lasted six months and included 25 patients , with ages ranging from 18 to 43 years old . Assessment was based on radiographs taken immediately postoperatively and at the third and sixth month of follow up in the anterior cruciate ligament reconstruction . Reconstruction of ligaments was performed with tendon grafts of the semitendinosus and gracilis muscle fixated in the femur with transverse metal screw and in the tibia with interference screws . Patients were evaluated objective ly by tests ligament , grade d from zero to four crosses and subjectively by the Lysholm method preoperative and after sixth month follow up . Results : Significant increase in the tunnels diameters were observed , 20.56 % for radiographs in the anteroposterior view , 26.48 % in profile view and 23.22 % in computed tomography . Descriptive statistics showed significant improvement in subjective and objective clinical parameters . Conclusions : The bone tunnel enlargement is a phenomenon found in the first months after surgical reconstruction of the anterior cruciate ligament and it has no implication s on clinical outcomes in the short term . Level of Evidence II , Prospect i ve Study BACKGROUND Bone tunnel enlargement after anterior cruciate ligament ( ACL ) reconstruction is well documented in the literature . The cause of this tunnel enlargement is unclear , but is thought to be multifactorial , with mechanical and biological factors playing a role . AIM The aim of this prospect i ve study was to evaluate how the different techniques may affect the bone tunnel enlargement and clinical outcome . PATIENTS AND METHODS Forty-five consecutive patients undergoing ACL reconstruction with autologous doubled semitendinosus and gracilis tendons entered this study . They were r and omly assigned to enter group A ( In-Out technique , with cortical fixation and Interference screw ) and group B ( Out-In technique , metal cortical fixation on the femour and tibia ) . At a mean follow-up of 10 months , all the patients underwent CT scan exam to evaluate the post-operative diameters of both femoral and they underwent tibial tunnels clinical examination after 24 months . RESULTS The mean femoral tunnel diameter increased significantly from 9.05±0.3 mm to 10.01±2.3 mm in group A and from 9.04±0.8 mm to 9.3±1.12 mm in group B. The mean increase in femoral tunnel diameters observed in group A was significantly higher than that observed in group B ( p < 0.05 ) The mean tibial tunnel diameter increased significantly from 9.03±0.04 mm to 10.68±2.5 mm in group A and from 9.04±0.03 mm to 10.±0.78 mm in group B. The mean increase in tibial tunnel diameters observed in group A was significantly higher than that observed in group B ( p < 0.05 ) . No clinical differences were found between two groups and no correlations between clinical and radiological results were found in any patients of both groups . CONCLUSIONS Results of the study suggest that different mechanical fixation devices could influence tunnel widening . The lower stiffness of the fixation devices is probably responsible of the tunnel widening through the fixation devices 's micromotions in the femoral and tibial tunnels Background Several problems have been reported with use of allogenic grafts in anterior cruciate ligament reconstruction , including local immune response to allograft tendon within the synovial fluid , delayed maturation and ligamentization , and progressive tibial tunnel enlargement . Hypothesis There is a correlation between the use of allograft and tibial tunnel enlargement . Study Design Controlled laboratory study . Methods Twenty healthy adult female goats underwent allograft anterior cruciate ligament reconstruction and were followed with serial radiographs at 6-week intervals . Animals were r and omly chosen for sacrifice between 18 and 36 weeks for histologic assessment . Results Significant radiographic increases in tunnel size were noted within the first 6 weeks of healing and remained up to 36 weeks with no further remodeling noted . Histologic analysis showed progressive ligamentization of the allografts with tendon-to-tunnel wall biologic fixation with dense connective tissue . Remodeling and incorporation of the bone plug was seen in all cases . The allograft tendon underwent early fibrous attachment within the tunnel and remodeled toward ligament histologic structure . Remodeling and incorporation of the bone plug was seen by 18 weeks . Conclusion Tibial tunnel enlargement , consistent with that seen in humans after allograft anterior cruciate ligament reconstruction , did not appear to affect the ultimate incorporation of the allograft on a histologic level BACKGROUND Femoral and tibial tunnel widening ( TW ) after ACL reconstruction is a phenomenon increasing talk in the literature . It is underlying biological and mechanical causes . OBJECTIVE The aim of this study was to evaluate the relationship between bone tunnel enlargement and two different ACL fixation systems . PATIENTS AND METHODS 40 patient underwent ACL reconstruction with hamstring ; r and omly divided into group A with 20 patients treated with stiff systems ( femoral Rigidfix and tibial interference screw ) , and into group B , with 20 patients treated with morel elastic system ( femoral and tibial Tight-rope ) . Evaluated postoperatively with knee MRI at 40 days , 3 months , 6 months to measure bone tunnel diameters widening . RESULTS At 40 days tunnel widening between two groups shows no statistically difference . At 3 months postoperatively , femoral bone tunnel widening amounted on average to 1.84 mm in middle of tunnel and 1 mm at the mouth in joint in group A , and respectively 3.2 mm and 2.5 mm in group B ( p<0.05 ) . Tibial tunnel widening was 1.24 mm at the mouth in joint and 1.3 mm in middle in group A and respectively 2.26 mm and 2.43 mm in group B ( p<0.05 ) . At 6 months femoral tunnel widening amounted on average to 2.45 mm in middle and 1.35 mm at the mouth in joint in group A and respectively 3.5 mm and 2.7 mm in group B ( p<0.01 ) . Tibial tunnel widening amounted on average to 1.27 at mouth in joint and 1 mm in middle of tunnel in group A and respectively 2.6 mm and 2.3 mm in group B ( p<0.01 ) . CONCLUSIONS This study results suggest elastic fixation system increases bone tunnel enlargement after ACL reconstruction with hamstring without correlation with worse clinical performance . LEVEL OF EVIDENCE IV Anatomical observation and biomechanical studies have shown that the anterior cruciate ligament ( ACL ) mainly consists of two distinct bundles , the anteromedial ( AM ) bundle and posterolateral ( PL ) bundle . Conventional single-bundle ACL reconstruction techniques have focused on the restoration of the AM bundle while giving limited attention to the PL bundle . The purpose of this prospect i ve , r and omized clinical study is to compare the outcomes of ACL reconstruction when using either double-bundle or single-bundle technique and bioabsorbable interference screw fixation , and similar rehabilitation with both techniques . Sixty-five patients were r and omized into either double-bundle ( n = 35 ) or single-bundle ( n = 30 ) ACL reconstruction with hamstring tendons and bioabsorbable screw ( Hexalon , Inion Company , Tampere , Finl and ) fixation in both groups . The evaluation methods were clinical examination , KT-1000 arthrometer measurements , radiographic evaluation , as well as International Knee Documentation Committee and Lysholm knee scores . There were no differences between the study groups preoperatively . For an average of 14 months of follow-up ( range 12–20 months ) , 30 patients of the double-bundle group and 29 patients of the single-bundle group were available ( 91 % ) . At the follow-up , the rotational stability , as evaluated by pivot shift test , was significantly better in the double-bundle group than in the single-bundle group . However , in anterior stability of the knee , there was no significant difference between the groups . None of the patients in the double-bundle group had graft failure , while four patients in the single-bundle group had . In addition , knee scores were equal at the follow-up , and all the results were significantly better at the follow-up than preoperatively , in both groups PURPOSE The purpose of this study was to determine the time frame for tibial tunnel expansion in patients undergoing anterior cruciate ligament ( ACL ) reconstruction with hamstring autografts using an endoscopic technique . Does this expansion occur immediately after surgery or over the first 12 weeks of rehabilitation ? TYPE OF STUDY Observational study involving 10 patients . METHODS The single incision technique used a transtibial approach for drilling the femoral tunnel . Femoral fixation was accomplished with a closed-loop EndoButton ( Acufex , Smith & Nephew ; Mansfield , MA ) and tibial fixation with a soft tissue screw and washer augmented by a polylactic acid interference screw . Computed tomography ( CT ) scans were taken in a consistent manner at weeks 1 and 12 after surgery to measure tibial and femoral tunnel expansion . RESULTS The CT scans showed significant widening of the tibial tunnel between 1 and 12 weeks ( mean area of tibial tunnel increased from 82.5 to 112.7 mm2 ; P = .001 ) . Expansion of the femoral tunnel was also seen ; however , this change was not statistically significant ( P = .18 ) . CONCLUSIONS The expansion after surgery occurred over time , not immediately after surgery , and was probably caused by factors other than surgical technique . The significance of tibial tunnel expansion needs to be clinical ly correlated with a long-term study on the effect of tunnel expansion on graft survival Background : A long-term follow-up comparing double-bundle and single-bundle techniques for anterior cruciate ligament ( ACL ) reconstruction has not been reported before . Hypothesis : Double-bundle ACL reconstruction may have fewer graft ruptures , lower rates of osteoarthritis ( OA ) , and better stability than single-bundle reconstruction . Study Design : R and omized controlled trial ; Level of evidence , 2 . Methods : Ninety patients were r and omized for double-bundle ACL reconstruction with bioabsorbable screw fixation ( DB group ; n = 30 ) , single-bundle ACL reconstruction with bioabsorbable screw fixation ( SBB group ; n = 30 ) , and single-bundle ACL reconstruction with metallic screw fixation ( SBM group ; n = 30 ) . Evaluation methods consisted of a clinical examination , KT-1000 arthrometer measurements , International Knee Documentation Committee ( IKDC ) and Lysholm knee scores , and a radiographic examination of both the operated and contralateral knees . Results : Eighty-one patients ( 90 % ) were available at the 10-year follow-up . Eleven patients ( 1 in the DB group , 7 in the SBB group , and 3 in the SBM group ) had a graft failure during the follow-up and went on to undergo revision ACL surgery ( P = .043 ) . In the remaining 70 patients at 10 years , no significant group differences were found in the pivot-shift test findings , KT-1000 arthrometer measurements , or knee scores . The most OA findings were found in the medial compartment of the knee , with 38 % of the patients in the operated knee and 28 % of the patients in the contralateral nonoperated knee . However , no significant group difference was found . The most severe OA changes were in the patients who had the longest delay from the primary injury to ACL reconstruction ( P = .047 ) and in the patients who underwent partial meniscal resection at the time of ACL reconstruction ( P = .024 ) . Conclusion : Double-bundle ACL reconstruction result ed in significantly fewer graft failures than single-bundle ACL reconstruction during the follow-up . Knee stability and OA rates were similar at 10 years . The most severe OA changes were found in the patients who had the longest delay from the primary injury to ACL reconstruction and in the patients who underwent partial meniscal resection at the time of ACL reconstruction PURPOSE The purpose of this study was to determine the amount of tibial and femoral bone tunnel enlargement after double-bundle anterior cruciate ligament ( ACL ) reconstruction . METHODS Twenty-five consecutive patients undergoing primary double-bundle hamstring ACL reconstruction were included in a prospect i ve case series . Femoral fixation was performed by means of 2 EndoButton CL devices ( Smith & Nephew Endoscopy , And over , MA ) , and tibial fixation was done with 2 bioresorbable interference screws . Magnetic resonance imaging ( MRI ) was performed in all patients at a mean of 12.3 months postoperatively . Tunnel enlargement was determined by digitally measuring the widths perpendicular to the long axis of the anteromedial ( AM ) and posterolateral ( PL ) tunnels on an oblique coronal and axial plane . The MRI measurements were compared with the intraoperative drill diameter . RESULTS The mean tibial AM bone tunnel diameter increased from 0.74 to 1.06 cm , and the mean PL diameter increased from 0.60 to 0.89 cm . The mean femoral AM bone tunnel diameter increased from 0.71 to 0.97 cm , and the mean PL diameter increased from 0.58 to 0.85 cm . Bone tunnel enlargement was 43 % ( P = .001 ) for both tibial tunnels and 35 % ( P = .001 ) versus 48 % ( P < .001 ) for the femoral AM
Output:
| Bone – patellar tendon – bone ( BPTB ) allograft had the largest average tunnel widening overall .
BPTB autograft had the lowest average tunnel widening overall .
Double-bundle hamstring graft configuration had a lower average tunnel widening than single-bundle configuration .
Rehabilitation protocol s after ACLR that used a full weight-bearing prescription in rehabilitation showed a greater average femoral tunnel widening than partial weight-bearing , and partial weight-bearing showed a greater average tibial tunnel widening than full weight-bearing .
With respect to graft types , double-bundle hamstring autografts reported lower average femoral and tibial TW than single-bundle hamstring autografts .
BPTB autografts reported the lowest average TW and BPTB allograft the largest average TW of all the grafts . |
MS211425 | ***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 determine differences in interproximal plaque mass and fluoride retention with different modes of toothbrushing and flossing . MATERIAL S AND METHODS Forty-seven subjects in good health used four treatments in a four-period , r and omized , crossover design : 1 ) manual brushing only ; 2 ) manual brushing and daily flossing ; 3 ) electric brushing using a rotational oscillation toothbrush ; and 4 ) electric brushing using a sonic toothbrush . Subjects used a st and ard sodium fluoride dentifrice during the eight-day experimental periods and a fluoride-free dentifrice during the seven-day washout periods between treatments . Interproximal plaque sample s were taken on Day 1 and on Day 8 , weighed , and analyzed for fluoride content . RESULTS The amount of interproximal plaque was lowest with sonic brushing , which left 43 - 65 % less plaque than all other treatments . Manual brushing and flossing yielded less plaque than manual brushing alone and rotational oscillation brushing . Differences were statistically significant ( p < 0.05 ) for treatment ; there was no time effect on plaque mass . For fluoride retention , at Day 1 sonic brushing gave at least 54 % more fluoride in the interproximal plaque than all other treatments , which was significant . All treatments demonstrated a significant increase in fluoride concentration with time except manual brushing and flossing , which showed a significant decrease . At Day 8 , the fluoride concentration was significantly higher for sonic brushing than for manual brushing or rotational oscillation brushing by over 40 % , and all treatments exhibited significantly greater fluoride than the manual brushing and flossing combination . CONCLUSION The mode of toothbrushing may impact the amount of plaque retained interproximally and its fluoride concentration OBJECTIVE The purpose of this twenty-eight day , r and omized , single-blind clinical trial was to assess the efficacy of the addition of daily oral irrigation to both power and manual tooth brushing , compared to a traditional regimen of manual tooth brushing and flossing , to determine which regimen had the greatest effect on the reduction of gingival bleeding , gingivitis , and supragingival plaque . METHODOLOGY The study was design ed for a total of 105 subjects to participate in a twenty-eight day trial , with 35 subjects r and omly assigned to one of three groups : Group 1-manual toothbrush and floss ; Group 2-manual toothbrush and dental water jet ; and Group 3-sonic toothbrush and dental water jet . All subjects received written and verbal instructions for using their regimens . Subjects were asked to brush for a timed two minutes , twice per day , with the brush and the dentifrice provided , and to refrain from using any additional oral hygiene aids . Subjects using the dental water jet were instructed to use the water jet on a medium setting , irrigating once per day with 500 ml of luke warm water . Subjects using the dental floss were instructed to use the floss once daily . Subjects were examined by two calibrated examiners , and data were collected at baseline ( BSL ) , 14 days ( D14 ) , and 28 days ( D28 ) . Subjects were asked to abstain from any oral hygiene for 12 hours prior to each study visit . Subjects were scored using the Carter and Barnes Bleeding Index , Löe and Silness Gingival Index , and the Proximal/Marginal Plaque Index . Mean scores on the three indices for the three groups were used for statistical analysis at each time point . Additionally , the means were used for comparisons as change from baseline and percent change from baseline at D14 and D28 . The significance of percentage change in each index from baseline to D14 and D28 was evaluated using a one-tailed t-test . Significant differences are reported at alpha < or = 0.05 for these planned group comparisons . RESULTS Thirty-one subjects in Group 1 , 32 subjects in Group 2 , and 32 subjects in Group 3 completed the study . Bleeding Index : Groups 2 and 3 , the irrigation groups , were statistically significantly more effective than Group 1 in reducing the bleeding index at D14 and D28 , whether measured by mean reduction or percentage reduction . Gingival Index : At D14 , both irrigation groups demonstrated a statistically significantly greater reduction in the gingival index compared to brushing and flossing for the facial surfaces . There was no significant difference between groups for the lingual surface at D14 . At D28 there was a significant difference between Groups 1 and 2 for both the facial and lingual surfaces . Plaque Index : There was one significant difference between groups for the plaque index measured on the lingual surfaces . The manual toothbrush and floss were less effective than the sonic toothbrush and irrigation . Group 3 was also significantly better than Group 1 in reducing the plaque index on the facial surfaces at both D14 and D28 . On plaque percentage reduction on the facial surface , Group 2 was significantly better than Group 1 at D14 . There was no statistical difference between Group 1 and Group 2 at D28 . CONCLUSION The results of this clinical trial indicate that when combined with manual or sonic tooth brushing , oral irrigation is an effective alternative to manual tooth brushing and dental floss for reducing bleeding , gingival inflammation , and plaque removal BACKGROUND AND OBJECTIVE Dental calculus occurs as a consequence of supersaturation of saliva with respect to calcium phosphates . This mineralization of dental plaque can be delayed by the presence of crystallization inhibitors , such as pyrophosphate or bisphosphonates . Phytate inhibits brushite and hydroxyapatite crystallization and has the potential to prevent dental calculi formation . The aim of the present study was to examine the effects of phytate and zinc , administered in a mouthwash solution , to prevent the formation of dental calculus . MATERIAL AND METHODS Healthy dental plaque-forming volunteers ( n = 25 ) took part in a r and omized , double-blind , three-period crossover clinical study to assess the efficacy of a phytate-containing mouthwash in relation to control and placebo effects . Subjects rinsed their mouths for 1 min , twice each day , with 20 mL of the test solution , without ingestion . Mouthwash efficacy was assessed through quantification of the amounts of calcium , phosphorus and magnesium present in the residues obtained by dental cleaning , performed by a single trained examiner . RESULTS A good correlation was found among total calcium , magnesium and phosphorus in calcified dental plaque residues , indicating that any of these variables is adequate for evaluating the reduction of plaque crystallization as calcium phosphate . A statistically significant decrease in total calcium , magnesium and phosphorus was found in the phytate-treatment period compared with control and placebo periods , demonstrating the efficacy of the proposed treatment in reducing dental calculus formation . CONCLUSION The high efficacy of phytate in reducing dental calculus formation suggests that this substance may be an effective treatment for preventing the development of calculus deposits The purpose of the present study was to compare in untreated patients suffering from moderate to severe periodontitis the efficacy of dental floss ( DF ) and interdental brushes ( IDB ) in the reduction of plaque , gingival inflammation , and probing depth in a 6-week period prior to subgingival debridement . Twenty-six patients ( 12 female , 14 male ; mean age 37.4 years ; range 27 to 72 years ) were instructed to use DF for one side of the dentition and IDB for the other side as an adjunct to the daily toothbrushing for 6 weeks . Oral hygiene instructions for toothbrushing and the use of the two devices were given at baseline and at week 3 . Measurements were carried out at baseline and at 6 weeks including plaque scores , probing depth , and 2 bleeding scores ( periodontal pocket bleeding index and angulated bleeding index ) . With the IDB , the approximal plaque score at baseline of 3.09 reduced to 2.15 at 6 weeks and with DF from 3.10 to 2.47 , respectively . IDB proved to remove significantly more plaque than DF . Baseline probing depth of 5.84 mm for IDB sites and 5.59 mm for DF sites was reduced to 5.01 mm at 6 weeks for both regimens . Analysis showed that the use of IDB result ed in a greater pocket reduction . Both bleeding indices were slightly reduced with IDB and DF , but no differences between devices were found . In relation to patient acceptance , more problems were observed with DF , and IDB were felt to be more efficacious . In conclusion , the results of the present study indicate that in combination with a manual toothbrush , the use of interdental brushes is more effective in removal of plaque and results in a larger reduction of probing depth than the use of dental floss . Although the differences were small , they indicate , in combination with patient preferences , that interdental brushes are to be considered preferable to floss for interdental plaque removal in patients suffering from moderate to severe periodontitis OBJECTIVE The study was conducted to compare the performance of three interdental products to dental floss in the control and removal of plaque , and in the reduction of gingivitis . METHODOLOGY One-hundred and twenty subjects were screened for the presence of interproximal sites of a size suitable for a GUMO Go-Betweens cleaner , and for being in compliance with inclusion and exclusion criteria . They were then assessed with the Plaque , Gingivitis , and Eastman Interdental Bleeding Indices ( EIBI ) at baseline , given a prophylaxis , r and omly assigned to one of four products ( Glide dental floss , Butler flossers , GUM Go-Betweens cleaners , and GUM Soft-Picks cleaners ) , and given product use instructions . Subjects returned at three weeks for a compliance review and at six weeks for a final visit . Plaque was assessed at the final visit before and after using the assigned products . Plaque , gingivitis , and bleeding scores were evaluated by analysis of covariance using the baseline measurements as the covariate . RESULTS All four interdental products significantly reduced interdental plaque from baseline to before-use at the final visit ( after six weeks ) employing baseline plaque as a covariate . Reductions were 16 % to 24 % . Similarly , use of the products at the final visit result ed in 26 % to 31 % reductions in plaque with the before-use plaque as a covariate . Interdental gingivitis scores showed a reduction both lingually and buccally , with reductions ranging from 27 % to 36 % for the former and 34 % to 53 % for the latter ( baseline was the covariate ) . No statistical differences were found between the products on the lingual interdental sites . The Go-Betweens cleaners showed a statistically greater reduction in the Gingival Index score buccally than the other three products . No differences were noted among the products for the EIBI . CONCLUSION In this study , dental floss , the recognized " gold st and ard " for gingivitis reduction , was matched in performance by flossers and an interdental cleaner with small elastomeric fingers , and surpassed by an interdental brush . All products performed comparably for plaque reduction and removal AIM Regular dental flossing has been widely recommended to prevent periodontal diseases . Nevertheless , compliance is below a desirable level . This study evaluates the effects of a brief behavioural intervention on dental flossing and determines whether the effects of such an intervention are stronger in a specific subgroup of individuals ( those intending to floss regularly = implemental mindset ) . MATERIAL S AND METHOD Behavioural intervention ( planning when , where and how to floss ) trial was conducting with 194 participants assigned to an intervention or a control group by a r and om time schedule ; the primary outcome was vali date d self-report of flossing behaviour . Follow-up data were collected 2 and 8 weeks post-intervention . RESULTS Individuals receiving the planning intervention significantly outperformed those in the control condition at both the 2- and the 8-week follow-up ( 4.24 times flossing/week versus 3.9 at 2 weeks ; 4.02 versus 2.98 at 8 weeks ) . Intervention effects were stronger in individuals in the implemental mindset . Dropout rates were higher for participants who received the planning intervention but were not in the implemental mindset . CONCLUSION Planning interventions are an economic and effective way to change oral self-care behaviour , and are more effective in individuals in an implemental mindset The purpose of the present study was to compare the bleeding tendency as elicited by probing the marginal gingiva ( BOMP ) and probing to the bottom of the pocket ( BOPP ) in smokers and non-smokers in natural gingivitis and during experimental gingivitis . 11 smokers ( sm ) and 14 non-smokers ( nsm ) were recruited . When they had less than 20 % approximal bleeding sites , they entered a 14-day trial period of ' experimental gingivitis ' . Subjects returned 30 days later , after resuming normal oral hygiene procedures , for a final gingival assessment . A split-mouth design was chosen using 2 contra-lateral quadrants for each index ( being either BOMP or BOPP ) . A consistently higher bleeding score of approximately 10 % was observed by probing to the bottom of the pocket . At day 14 with both indices , a significant difference between smokers and non-smokers was detected ( BOMP : sm=15 % , nsm=30 % ; BOPP : sm=27 % , nsm=44 % ) . The increment between gingival health and experimental gingivitis was significantly higher in non-smokers than in smokers but comparable for both indices ( BOMP : sm=8 % , nsm=23 % ; BOPP : sm=9 % , n
Output:
| No studies reported the effectiveness of flossing plus toothbrushing for preventing dental caries |
MS211426 | ***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 Cerebral low- grade gliomas ( LGG ) in adults are mostly composed of astrocytomas , oligodendrogliomas , and mixed oligoastrocytomas . There is at present no consensus in the policy of treatment of these tumors . We sought to determine the efficacy of radiotherapy and the presence of a dose-response relationship for these tumors in two multicentric r and omized trials conducted by the European Organization for Research and Treatment of Cancer ( EORTC ) . The dose-response study is the subject of this article . METHODS AND MATERIAL S For the dose-response trial , 379 adult patients with cerebral LGGs were r and omized central ly at the EORTC Data Center to receive irradiation postoperatively ( or postbiopsy ) with either 45 Gy in 5 weeks or 59.4 Gy in 6.6 weeks with quality -controlled radiation therapy . All known parameters with possible influences on prognosis were prospect ively recorded . Conventional treatment techniques were recommended . RESULTS With 343 ( 91 % ) eligible and evaluable patients followed up for at least 50 months with a median of 74 months , there is no significant difference in terms of survival ( 58 % for the low-dose arm and 59 % for the high-dose arm ) or the progression free survival ( 47 % and 50 % ) between the two arms of the trial . However , this prospect i ve trial has revealed some important facets about the prognostic parameters : The T of the TNM classifications as proposed in the protocol appears to be one of the most important prognostic factors ( p < 0.0001 ) on multivariate analysis . Other prognostic factors , most of which are known , have now been quantified and confirmed in this prospect i ve study . CONCLUSION The EORTC trial 22844 has not revealed the presence of radiotherapeutic dose-response for patients with LGG for the two dose levels investigated with this conventional setup , but objective prognostic parameters are recognized . The tumor size or T parameter as used in this study appears to be a very important factor PURPOSE To compare survival and toxicity in adult patients treated with low-dose ( 50.4 Gy/28 fractions ) versus high-dose ( 64.8 Gy/36 fractions ) localized radiation therapy ( RT ) for supratentorial low- grade astrocytoma , oligodendroglioma , and mixed oligoastrocytoma . PATIENTS AND METHODS From 1986 to 1994 , 203 eligible/analyzable patients were r and omized : 101 to low-dose RT , 102 to high-dose RT . Almost half were younger than 40 years , and 95 % had grade 2 tumors . Histologic subtype was astrocytoma ( or mixed oligo-astrocytoma with astrocytoma dominant ) in 32 % of patients and oligodendroglioma ( or oligoastrocytoma with oligodendroglioma dominant ) in 68 % . Tumor diameter was less than 5 cm in 35 % of patients , and 41 % of tumors showed some degree of contrast enhancement . Extent of resection was gross total in 14 % of patients , subtotal in 35 % , and biopsy only in 51 % . RESULTS At the time of the present analysis , 83 patients ( 41 % ) are dead , and median follow-up is 6.43 years in the 120 who are still alive . Survival at 2 and 5 years is nonsignificantly better with low-dose RT ; survival at 2 and 5 years was 94 % and 72 % , respectively , with low-dose RT and 85 % and 64 % , respectively , with high-dose RT ( log rank P = .48 ) . Multivariate analysis identified histologic subtype , tumor size , and age as the most significant prognostic factors . Survival is significantly better in patients who are younger than 40 years and in patients who have oligodendroglioma or oligo-dominant histology . Grade 3 to 5 radiation neurotoxicity ( necrosis ) was observed in seven patients , with one fatality in each treatment arm . The 2-year actuarial incidence of grade 3 to 5 radiation necrosis was 2.5 % with low-dose RT and 5 % with high-dose RT . CONCLUSION This phase III prospect i ve r and omized trial of low- versus high-dose radiation therapy for adults with supratentorial low- grade astrocytoma , oligodendroglioma , and oligoastrocytoma found somewhat lower survival and slightly higher incidence of radiation necrosis in the high-dose RT arm . The most important prognostic factors for survival are histologic subtype , tumor size , and age . The study design of the ongoing intergroup trial in this population will be discussed We report the prognostic significance of tumor CT contrast enhancement within histological subgroups in 831 consecutive adult glioma patients of high- grade ( n=516 ) and low- grade ( n=315 ) histology . In the present report , a negative prognostic factor is associated with shortened survival . Methods : Survival analysis including Kaplan-Meier plots , log-rank tests , Cox analysis , and Aalen 's linear model as implemented in SPSS and S-PLUS . Results : Sensitivity and specificity of contrast enhancement as a test for high- grade glioma was 0.87 and 0.79 , respectively . Enhancement was a strong negative prognostic factor comparable to high- grade histology in the total patient population . Enhancement was also a negative prognostic factor within the subgroups adult high- grade ( Grade 3–4 ) , anaplastic ( Grade 3 ) , and low- grade ( Grade 1–2 ) gliomas ( p < 0.001 ) . The prognostic implication s of initial enhancement declined in high- grade patients surviving beyond 36 months . Tumor contrast enhancement or calcifications ( in parentheses ) were present in 96 % ( 3.6 % ) of glioblastomas , in 87 % ( 7.4 % ) of high- grade gliomas , in 56.5 % of anaplastic gliomas , and in 21 % ( 16.2 % ) of low- grade gliomas . Calcification was a positive prognostic factor within the high- grade group of patients ( p < 0.0001 ) . Conclusion : Enhancement was a major prognostic factor comparable to high- grade histology in this glioma patient population . Enhancement was a negative prognostic factor within each of the adult subgroups high- grade , anaplastic ( grade 3 ) , and low- grade gliomas . Enhancement was strongly associated with but not pathognomonic for high- grade histology Summary . Background : Patients with radiologically ( MRI and /or CT images ) suspected malignant glioma is referred to radiotherapy after craniotomy and resection of the tumour or after diagnostic biopsy . Patients with poor preoperative status and elderly patients are diagnosed more often by biopsy and treated by radiotherapy rather than by craniotomy and tumour resection . However , based on previous retrospective studies it is not possible to conclude which procedure is better for elderly patients . Thus a prospect i ve study comparing these two procedures with elderly patients was planned . Methods : 30 patients older than 65 years with radiologically ( CT and /or MRI ) obvious malignant glioma were r and omised into two groups : I ) stereotactic biopsy and II ) open craniotomy and resection of the tumour . Nineteen patients were diagnosed to have grade IV glioma and four patients grade III glioma . Seven out of 30 ( 23 % ) were followed in the “ intention-to-treat ” group with diagnosis of stroke ( n=3 ) , metastasis ( n=2 ) , malignant lymphoma ( n=1 ) and one with out histological diagnosis . Patients with histologically verified malignant glioma ( grade III – IV ) were diagnosed by stereotactic biopsy ( n=13 ) or by open craniotomy and resection ( n=10 ) and all the patients were referred to radiotherapy . Survival and time of deterioration were followed . Findings : The overall median survival time was 146 ( 95 % CI 89–175 ) days after the procedure . The estimated median survival time was 171 ( 95 % CI 146–278 ) days after the craniotomy versus 85 ( 95 % CI 55–157 ) days after the biopsy ( p=0.035 ) . The estimated survival time was 2.757 times longer ( 95 % CI 1.004–7.568 , p=0.049 ) after craniotomy . However , there was no significant difference in the time of deterioration between these two treatments ( p=0.057 ) . Amount of radiotherapy given had a significant effect on survival ( p=0.001 ) . Interpretation : Longer survival time is achieved after open craniotomy and resection of tumour . However , overall benefit of open surgery to patient seems to be modest , while time of deterioration did not differ between two treatment groups . Our results support previous studies on the benefit of radiotherapy in the treatment of malignant glioma OBJECTIVE To evaluate diffusion tensor imaging (DTI)-based functional neuronavigation in surgery of cerebral gliomas with pyramidal tract ( PT ) involvement with respect to both perioperative assessment and follow-up outcome . METHODS A prospect i ve , r and omized controlled study was conducted between 2001 and 2005 . A consecutive series of 238 eligible patients with initial imaging diagnosis of cerebral gliomas involving PTs were r and omized into study ( n = 118 ) and control ( n = 120 ) groups . The study cases underwent DTI and three-dimensional magnetic resonance imaging scans . The maps of fractional anisotropy were calculated for PT mapping . Both three-dimensional magnetic resonance imaging data sets and fractional anisotropy maps were integrated by rigid registration , after which the tumor and adjacent PT were segmented and reconstructed for presurgical planning and intraoperative guidance . The control cases were operated on using routine neuronavigation . RESULTS There was a trend for high- grade gliomas ( HGGs ) in the study group to be more likely to achieve gross total resection ( 74.4 versus 33.3 % , P < 0.001 ) . There was no significant difference of low- grade gliomas resection between the two groups . Postoperative motor deterioration occurred in 32.8 % of control cases , whereas it occurred in only 15.3 % of the study cases ( P < 0.001 ) . The 6-month Karnofsky Performance Scale score of study cases was significantly higher than that of control cases ( 86 ± 20 versus 74 ± 28 overall , P < 0.001 ; 93 ± 10 versus 86 ± 17 for low- grade gliomas , P = 0.013 ; and 77 ± 27 versus 53 ± 32 for HGGs , P = 0.001 ) . For 81 HGGs , the median survival of study cases was 21.2 months ( 95 % confidence interval , 14.1–28.3 mo ) compared with 14.0 months ( 95 % confidence interval , 10.2–17.8 mo ) of control cases ( P = 0.048 ) . The estimated hazard ratio for the effect of DTI-based functional neuronavigation was 0.570 , representing a 43.0 % reduction in the risk of death . CONCLUSION DTI-based functional neuronavigation contributes to maximal safe resection of cerebral gliomas with PT involvement , thereby decreasing postoperative motor deficits for both HGGs and low- grade gliomas while increasing high- quality survival for HGGs OBJECTIVE A prospect i ve volumetric analysis of extent of resection ( EOR ) was carried out to assess surgical outcomes in adults diagnosed with hemispheric low grade gliomas ( LGGs ) . MATERIAL S AND METHODS 68 consecutive patients diagnosed with LGGs were enrolled in the study . Pre- and post-operative tumor volumes and EOR were measured based on FLAIR MRI . Dynamic susceptibility contrast perfusion magnetic resonance imaging ( DSC MRI ) was used for the assessment of relative cerebral blood volume ( rCBV ) . Three outcome measures were assessed : overall survival ( OS ) , progression-free survival ( PFS ) , and malignant degeneration-free survival ( MFS ) . RESULTS In 6 ( 9 % ) patients permanent neurologic deficits were observed . No statistically significant dependence between the EOR and the occurrence of permanent deficits was found . The eloquent or close to the eloquent location was statistically connected with lower EOR ( p=0.023 ) . The preoperative volume of tumors treated with gross total resection was significantly smaller than the volume of tumors in subtotal or partial resection groups ( p=0.020 , p<0.001 , respectively ) . OS was predicted by age at diagnosis ( p=0.032 ) , and rCBV ( p=0.002 ) . Progression and malignant transformation occurred in 22 ( 32 % ) and 11 ( 16 % ) out of 68 patients . PFS was predicted by preoperative tumor volume ( p=0.005 ) , postoperative tumor volume ( p=0.008 ) , the EOR ( p=0.001 ) , and by the rCBV ( p=0.033 ) . MFS was predicted by preoperative tumor volume ( p=0.0
Output:
| Some retrospective studies and non-r and omized prospect i ve studies do seem to suggest improved OS and seizure control correlating to higher extent of resection .
Future research could focus on RCTs to determine outcomes benefits for biopsy versus resection |
MS211427 | ***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 scarce information regarding the role of hepatitis C virus ( HCV ) infection in the development of infectious complications after kidney transplantation ( KT ) . Methods . We prospect ively analyzed all KT recipients included in the Spanish Network for the Research of Infection in Transplantation cohort from September 2003 to February 2005 with a posttransplant follow-up of 3 years and compared the incidence of both overall and specific infections according to the pretransplant anti-HCV antibody status . Results . Of 1302 analyzed recipients , 105 ( 8.1 % ) were anti-HCV positive . These patients presented a higher rate of previous transplant ( P<0.001 ) , had a lower donor age ( P=0.055 ) , higher transfusion requirements ( P=0.037 ) , and more frequently received induction therapy with antithymocyte antibodies ( P=0.005 ) . We found no differences between anti-HCV-positive and -negative recipients in the overall incidence rate of infection ( 0.82 vs. 0.74 episodes per 1000 transplant-days , respectively ) . Nevertheless , anti-HCV-positive recipients had a higher cumulative incidence of bloodstream ( P=0.01 ) and upper urinary tract infections ( P=0.037 ) . Anti-HCV status emerged by logistic regression as an independent risk factor only for bloodstream infection ( odds ratio , 3.14 ; 95 % confidence interval , 1.19–8.24 ; P=0.020 ) . Anti-HCV-positive recipients also experimented a higher rate of recurrent acute rejection ( P=0.045 ) and retransplantation ( P=0.017 ) , with no differences in overall mortality . Conclusions . According to the results of the Spanish Network for the Research of Infection in Transplantation cohort , the incidence of some potentially severe posttransplant infections may be increased in anti-HCV-positive KT recipients BACKGROUND Traditional and largely qualitative review s of evidence are now giving way to much more structured systematic overviews that use a quantitative method to calculate the overall effect of treatment . The latter approach is dependent on the quality of primary studies , which may introduce bias if they are of poor method ologic quality . OBJECTIVE To test the hypothesis that the inclusion of poor- quality trials in meta-analyses would bias the conclusions and produce incorrect estimates of treatment effect . METHODS An overview of r and omized trials of antiestrogen therapy in subfertile men with oligospermia was performed to test the hypothesis . Data sources included online search ing of MEDLINE and Science Citation Index data bases between 1966 and 1994 , scanning the bibliography of known primary studies and review articles , and contacting experts in the field . After independent , blind assessment , nine of 149 originally identified studies met the inclusion criteria and were selected . We assessed study quality independently . Outcome data from each study were pooled and statistically summarized . RESULTS There was a marginal improvement in pregnancy rate with antiestrogen treatment ( odds ratio , 1.6 ; 95 % confidence interval , 0.9 to 2.6 ) . Sensitivity analyses on the basis of method ologic quality demonstrated that poor- quality studies produced a positive effect with treatment , whereas no benefit was observed with high- quality studies . CONCLUSION The results of a meta- analysis are influenced by the quality of the primary studies included . Method ologically , poor studies tend to exaggerate the overall estimate of treatment effect and may lead to incorrect inferences Hepatitis C virus ( HCV ) can be transmitted by transplantation of cadaver organs from donors with antibody to HCV ( anti-HCV ) ; therefore , transplantation of organs from anti-HCV positive donors to anti-HCV-negative recipients has been discouraged . We have looked at outcomes in recipients of organs from anti-HCV positive and negative donors to determine whether this advice is well-founded . Stored sera from 716 consecutive cadaver organ donors procured by the New Engl and Organ Bank between 1986 and 1990 were tested for anti-HCV by a first-generation ELISA ( ELISA1 ) ; 13 ( 1.8 % ) were positive . 29 recipients who received organs from these donors were the study group . 37 donors were r and omly selected from 703 ELISA1-negative cadaver organ donors . 74 recipients of organs from these 37 donors were the control group . Clinical records were review ed and recipient sera were tested for anti-HCV with a second-generation ELISA ( ELISA2 ) , and HCV RNA was tested for by polymerase chain reaction . Median post-transplant follow-up was 42 and 49 months for study and control groups . Post-transplantation prevalence of anti-HCV and HCV RNA was 67 % and 96 % among recipients from anti-HCV-positive donors , and 20 % and 18 % among recipients from anti-HCV-negative donors ( p < 0.001 ) . Post-transplantation non-A , non-B hepatitis , graft loss , and death were observed in 55 % , 52 % , and 31 % among recipients of organs from anti-HCV-positive donors , and 16 % , 53 % , and 33 % among recipients from anti-HCV-negative donors . In a proportional hazards model , the relative risks for non-A , non-B hepatitis , graft loss , and death among recipients from anti-HCV-positive donors were 4.37 ( 95 % CI 1.97 - 9.70 ) , 0.93 ( 0.51 - 1.70 ) , and 0.89 ( 0.41 - 1.93 ) . Transmission of HCV infection by organ transplantation increased the risk of liver disease among recipients . However , after 3.5 years , donor HCV infection did not adversely affect patient survival or graft survival Background . Hepatitis C virus ( HCV ) infection is common in kidney transplantation and is known to affect long-term patient and graft survival , as is time in renal-replacement therapy ( RRT ) . The aim of this study was to investigate HCV in relation to time in RRT and its impact on outcome after transplantation . Methods . A follow-up cohort study using Kaplan-Meier analysis and Cox proportional hazards model was performed in 545 kidney and 26 kidney-pancreas transplant recipients receiving transplants between 1989 and 1997 , with last follow-up on December 31 , 2002 . HCV status at transplantation and time in RRT were analyzed . Results . Time in RRT was significantly longer ( P<0.0001 ) , and previous transplantations were more common ( P=0.04 ) in the HCV-positive group . HCV significantly reduced patient ( P=0.0012 ) and graft survival ( P=0.0003 ) after transplantation . Adjustment for age , sex , diabetes , previous transplantations , type of transplant , and time in RRT result ed in a relative risk ( RR ) for death of 2.23 , 1.92 , and 1.07 for HCV , diabetes , and age , respectively . The RR for graft loss was 1.96 and 1.03 for HCV and age . Sex , previous transplants , and time in RRT did not affect HCV as an independent risk factor for patient or graft survival . The leading cause of death was cardiovascular disease in both groups . Conclusions . HCV was , in our series , more important than time in RRT for patient death and graft loss posttransplant . Successful pretransplant antiviral therapy could be more beneficial for HCV-infected patients rather than early transplantation for long-term outcome , but this needs to be studied prospect ively Controversy exists regarding the impact of pre-transplantation HCV infection on the outcome of renal transplantation . We compared the prevalence of post-transplantation liver disease and graft and patient survival among kidney transplant recipients with and without anti-HCV at the time of transplantation . Pre-transplantation sera from 103 r and omly selected recipients of kidneys from anti-HCV-negative donors were tested for anti-HCV using a second generation ELISA . Twenty-three ( 22 % ) were positive for anti-HCV and 80 ( 78 % ) were negative . Anti-HCV-positive recipients had a longer time on dialysis ( P=0.003 ) and had a higher number of previous transplants ( P=0.01 ) . Further , 61 % of anti-HCV-positive patients had a history of liver disease compared with 13 % of anti-HCV-negative patients ( P<0.001 ) . HCV RNA was detected in the pretransplantation serum in 61 % of anti-HCV positive recipients compared with 5 % of anti-HCV-negative recipients ( P<0.001 ) . Clinical follow-up on both anti-HCV-positive and -negative patients was obtained until December , 1993 . Median posttransplantation follow-up among recipients with anti-HCV prior to transplantation ( 45 months ) was shorter ( P=0.05 ) than that for recipients without anti-HCV ( 66 months ) . For recipients with anti-HCV prior to transplantation , the relative risk of posttransplantation liver disease was 5.0 ( 95 % confidence intervals of 2.4 to 10.5 ) ; the relative risk of graft loss was 1.3 ( 95 % confidence intervals of 0.6 to 2.6 ) ; the relative risk of death was 3.3 ( 95 % confidence intervals of 1.4 to 7.9 ) , and the relative risk of death due to sepsis was 9.9 ( 95 % confidence intervals of 2.6 to 38.3 ) . The results of this study demonstrate that pretransplantation HCV infection is associated with an increased risk of liver disease and death after renal transplantation . These results raise the question of whether anti-HCV-positive patients on dialysis should be offered renal transplantation as opposed to continuing dialysis
Output:
| This meta- analysis of observational studies supports the notion that HCV-positive patients after RT have an increased risk of mortality and graft loss . |
MS211428 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: UNLABELLED Despite the high incidence of chronic ankle instability ( CAI ) , the underlying neurophysiologic mechanism is unknown . Evidence suggests that both feed-forward and feedback mechanisms may play a role . However , no investigation has examined both control mechanisms during the same movement task in the same cohort of CAI patients . PURPOSE To determine the neuromuscular and biomechanical control alterations present in CAI patients during planned ( feed-forward ) and unplanned ( feedback ) gait termination . METHODS Twenty subjects with CAI and 20 uninjured controls completed planned and unplanned gait termination protocol s. Both tasks began with subjects walking at a self-selected speed across a 12-m walkway . Unplanned gait termination required subjects to stop during r and omly selected trials on two adjacent force plates when cued . Planned gait termination required purpose ful stopping on the force places . Propulsive and braking force magnitude and the dynamic postural stability index were calculated from the result ing ground reaction forces . In addition , muscle activity from the soleus , tibialis anterior , and gluteus medius was collected bilaterally . RESULTS Both maximum propulsive ( CAI = 99.8 + /- 40.8 N , control = 88.6 + /- 33.6 N ) and braking ( CAI = 207.1 + /- 80.9 N , control = 161.6 + /- 62.2 N ) forces were significantly higher in the CAI group . The dynamic postural stability index revealed higher scores in the CAI group ( 0.24 + /- 0.03 ) compared with the control group ( 0.22 + /- 0.03 ) . Muscle activation of the soleus and tibialis anterior differed during unplanned and planned gait termination between groups ( P < 0.05 ) and between the limbs of the CAI group ( P < 0.05 ) . CONCLUSIONS Altered biomechanical strategies during both planned and unplanned gait termination indicate that patients with CAI have alterations in feed-forward neuromuscular control and suggest the presence of feedback neuromuscular control deficits CONTEXT Assessment tools should identify functional limitations associated with functional ankle instability ( FAI ) by discriminating unstable from stable ankles . OBJECTIVE To identify assessment tools that discriminated FAI from stable ankles and determine the most accurate assessment tool for discriminating between FAI and stable ankles . DESIGN Case-control study . SETTING Research laboratory . PATIENTS OR OTHER PARTICIPANTS Fifteen individuals with FAI and 15 healthy individuals ; participants with unilateral FAI reported " giving-way " sensations and ankle sprains , whereas healthy participants did not . INTERVENTION(S ) Participants answered 12 questions on the Ankle Joint Functional Assessment Tool ( AJFAT ) . They also performed a single-leg jump l and ing , which required them to jump to half their maximum jump height , l and on a single leg , and stabilize quickly on a force plate . MAIN OUTCOME MEASURE(S ) Receiver operating characteristic curves determined cutoff scores for discriminating between ankle groups for AJFAT total score and result ant vector ( RV ) time to stabilization . Accuracy values for discriminating between groups were determined by calculating the area under the receiver operating characteristic curves . RESULTS The cutoff score for discriminating between FAI and stable ankles was > or = 26 ( sensitivity = 1 , specificity = 1 ) and > or = 1.58 seconds ( sensitivity = 0.67 , specificity = 0.73 ) for the AJFAT total score and RV time to stabilization , respectively . The area under the curve for the AJFAT was 1.0 ( asymptotic significance < .05 ) , whereas the RV time to stabilization had an area under the curve of 0.72 ( asymptotic significance < .05 ) . CONCLUSIONS The AJFAT was an excellent assessment tool for discriminating between ankle groups , whereas RV time to stabilization was a fair assessment tool . Although both assessment s discriminated between ankle groups , the AJFAT more accurately discriminated between groups than the RV time to stabilization did . Future research ers should confirm these findings using a prospect i ve research design OBJECTIVE To identify changes in ground reaction force during jump l and ing in subjects with functional instability of the ankle joint . DESIGN Comparison of ground reaction force during jump l and ing between subjects with functional instability and healthy controls . BACKGROUND We have recently demonstrated significantly altered patterns of ankle and knee movement immediately pre- and post-impact in subjects with functional instability compared to healthy controls . We now examine the changes in timing and magnitude of forces sustained by the unstable ankle during jump l and ing . METHODS Fourteen subjects with unstable ankles and 10 age , sex and activity matched controls performed five single leg jumps onto a force platform whilst ground reaction forces were sample d. Timing and magnitudes of forces during the first 150 ms following impact were analysed and compared between groups . RESULTS Lateral and anterior force peaks occurred significantly earlier in subjects with functional instability . Significant differences were seen between groups ' time-averaged vertical , frontal and sagittal components of ground reaction force . These ranged from 5 % ( frontal force ) to 100 % ( vertical force ) of body mass . These changes occur immediately post-impact and too early for reflex correction/modification . CONCLUSIONS The disordered force patterns observed in subjects with functional instability are likely to result in repeated injury due to significant increase in stress on ankle joint structures during jump l and ing . We suggest that they are most likely to result from deficits in feed-forward motor control . RELEVANCE These results identify the potentially injurious nature of the changes in the forces applied to the unstable ankle joint during jump l and ing . The timing of these changes suggests that they are caused by a motor control deficit . Treatment approaches aim ed at retraining feed-forward control of ankle joint movement could succeed in restoring more normal patterns of force absorption and reduce the occurrence of repeated micro-trauma to ankle structures Twenty-seven patients who had a unilateral displaced intra-articular fracture of the calcaneus were managed with a cast instead of with reduction or an operation . The clinical result after a mean of six years ( range , two to ten years ) was excellent in five patients , good in five , fair in seven , and poor in ten . The sixteen patients who were re-examined for this study and for whom the gait was analyzed demonstrated abnormalities in ground-reaction force with regard to vertical force ( F3 ) and temporal force factors ( T2 , T3 , T6 , and T9 ) . Analysis of temporal and distance factors showed a trend toward a decreased proportion of single-limb support on the involved side . Three-dimensional motion analysis of the ankle and hindfoot was performed with electrogoniometers as the subject walked on a level surface , on a 10-degree side-slope , and up and down stairs . Motion was decreased in the sagittal , coronal , and transverse planes during walking on level ground and on a side-sloping surface . Significant decreases in motion in these planes were also seen during walking up and down stairs . Although these patients did not have a subsequent reconstructive operation , most had a residual functional deficit BACKGROUND Chronic ankle instability is a common occurrence after an ankle sprain . Yet , some people ( copers ) possess a mechanism that limits recurrent injury and disability . During gait termination , those with chronic ankle instability exhibit altered feed-forward and feedback control but little is known about alterations in copers . Therefore , the purpose of this investigation was to determine the biomechanical control alterations present in controls , copers , and those with chronic ankle instability during planned and unplanned gait termination . METHODS Twenty subjects with chronic ankle instability , 20 copers , and 20 uninjured controls completed planned and unplanned gait termination tasks . Unplanned gait termination required subjects to stop , when cued , during r and omly selected trials . Planned gait termination required intended stopping . A total of 10 trials were recorded for each condition . Normalized propulsive and braking force magnitudes and dynamic postural stability indices were calculated and compared among the groups . FINDINGS Normalized maximum braking forces were significantly higher in the chronic ankle instability group ( Mean : 2.82 SD : 0.93N/kg ) , relative to copers ( Mean : 2.59 SD : 0.84N/kg ) and controls ( Mean : 2.51 SD : 0.78N/kg ) . Similarly , the antero-posterior postural stability index revealed higher scores in the chronic ankle instability group ( Mean : 0.15 SD : 0.03 ) compared to the coper ( Mean : 0.14 SD : 0.02 ) and control group ( Mean : 0.14 SD : 0.02 ) . Copers did not differ from controls . INTERPRETATION The findings suggest that the ability of copers to terminate gait in a manner similar to uninjured controls may represent part of the underlying mechanism that limits recurrent injury and disability in copers BACKGROUND Functional instability of the ankle joint may interfere with proper execution of quick cutting movements in sports . Previous studies have provided information regarding the ground reaction force characteristics in such movements in healthy players but no research was found in players with ankle instability . The purpose of this study was to evaluate and compare ground reaction forces in functionally unstable ankles with healthy ones during two cutting movements , the v-cut and the defensive shuffle . METHODS Fifteen male basketball players with self reported unilateral functional instability and 17 matched controls , performed three v-cuts and three defensive shuffles on two synchronised force platforms . Both joints were tested and ground reaction forces analysed by an one-way ANOVA for independent groups to test differences between groups , and paired t-test to examine differences within affected players . FINDINGS Unstable ankles , demonstrated significantly greater first vertical force peak , than contralateral unaffected joints ( P < or = 0.05 ) and lower relative time to peak than controls ( P < or = 0.05 ) , during v-cut movement . No significant differences were seen in variables between groups during lateral shuffling . INTERPRETATION Unstable ankles demonstrated altered patterns of ground reaction forces , with a rapid onset of high vertical force during the first millisecond post-impact , while the medial component was unchanged . Although the increased vertical forces are considered predisposing factors to repeated injury , this finding is likely a neuromuscular response making the ankle joint more stable avoiding excessive inversion forces BACKGROUND Little information is available about gait changes in ankle osteoarthritis and total ankle replacement , and also about total ankle replacement patients ' rehabilitation in the first year after surgery . METHODS Thirty subjects were included in this study : 15 unilateral post-traumatic ankle osteoarthritis patients and 15 age-/gender-matched control subjects . Patients were followed prospect ively : preoperatively , at 3 , 6 , 9 , and 12 months after total ankle replacement . The clinical -functional level was assessed by the American Orthopaedic Foot and Ankle Society ankle and the Short-Form-36 health survey score . 3D ankle-hindfoot kinematic-kinetic analysis was performed using a motion analysis and a two-plate force-platform system . Statistics included repeated measures analysis of variances , independent sample and paired Student 's t-tests ( significance alpha=0.05 ) . FINDINGS Compared to normal subjects , ankle osteoarthritis caused significant reduction of the American Orthopaedic Foot and Ankle Society and Short-Form-36 score . In gait analysis , ankle osteoarthritis showed a significant deficiency in six of seven spatiotemporal variables , a decrease of the tri-planar ankle movement , a decrease of the second active maximal vertical and the maximal medial ground reaction force , a reduction of the sagittal and transverse ankle joint moments , a reduction of the ankle joint power . Three months after total ankle replacement surgery patients experienced a worsening of gait . At 12 months follow-up , all spatiotemporal variables were not different from the normal subjects ( full rehabilitation ) ; in six of 11 kinematic and kinetic variables there was a partial rehabilitation . INTERPRETATION This study provides data for the clinical -biomechanical underst and ing of the normal , arthritic , and total ankle replacement treated ankle during walking and the first year of rehabilitation
Output:
| The ' walking ' test showed significant differences in a great variety of pathologies , with the magnitude and timing of the ' second peak vertical force ' as proven relevant parameters .
INTERPRETATION This study provides recommendations concerning the potential of various dynamic tests and force plate parameters as a tool to compare neuromusculoskeletal function between patients with foot and ankle pathology and healthy controls |
MS211429 | ***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 This study evaluated the efficacy and tolerability of tramadol 37.5-mg/acetaminophen 325-mg combination tablets ( tramadoUAPAP ) as add-on therapy in subjects with rheumatoid arthritis ( RA ) pain that was inadequately controlled by NSAIDs and disease-modifying antirheumatic drugs alone . METHODS Subjects in this multicenter , double-blind trial were r and omized in a 3:1 ratio to receive 1 tramadol/ APAP tablet TID or a matching placebo for 1 week . Stable doses of previous medications were continued during the study . The primary efficacy variable was the mean daily pain relief score over 1 week , measured on a 6-point scale ( 4 = complete ; ' = a lot ; 2 = some ; 1 = a little ; 0 = none ; -1 = worse ) . Secondary outcomes included the mean daily pain intensity score , measured on a 100-mm visual analog scale ( VAS ) ( from 0 mm = no pain to 100 mm = extreme pain ) ; pain intensity and pain relief at day 7 ; subjects ' and investigators ' mean overall assessment s of study drug , measured on a Likert scale ( from 2 = very good to -2 = very poor ) ; and subjects ' assessment s of 8 aspects of physical function ( measured on the Health Assessment Question naire ) . RESULTS Of 277 subjects r and omized to treatment , 267 ( 201 tramadol/APAP , 66 placebo ) were included in the intent-to-treat population . Mean ( SD ) daily pain relief scores at the end of 1 week were significantly greater in the tramadol/APAP group compared with the placebo group ( 1.04 [ 0.89 ] vs 0.78 [ 0.80 ] , respectively ; P = 0.037 ) , and mean daily pain intensity scores at the end of 1 week were significantly lower ( 47.23 [ 19.96 ] vs 53.81 [ 16.59 ] ; P = 0.018 ) . Physical function at the end of 1 week did not differ significantly between tramadol/APAP and placebo . Two hundred seventy-two subjects ( 205 tramadol/APAP , 67 placebo ) were evaluable for tolerability . One hundred thirty-three of these subjects had at least 1 adverse event . The incidence of adverse events was significantly higher in the tramadol/APAP group than in the placebo group ( 57.6 % vs 22.4 % ; P < 0.001 ) . Discontinuations due to adverse events occurred in 19.0 % of the tramadol/APAP group and 3.0 % of the placebo group ( P = 0.001 ) . Of 213 treatment-related adverse events in tramadol/APAP subjects , nausea ( 34.1 % ) was the most frequent , followed by dizziness ( 20.0 % ) and vomiting ( 15.6 % ) . One serious adverse event -- chest discomfort , nausea , and vomiting after taking study medication-occurred in a subject receiving tramadol/APAP The symptoms resolved 1 day after discontinuing tramadol/APAP . CONCLUSIONS In this study , tramadol/APAP used as add-on therapy in subjects with symptomatic RA was associated with a significant improvement in pain relief and a significant reduction in pain intensity compared with placebo , with no improvement in physical function . Use of tramadol/APAP may be considered when analgesics are needed in addition to conventional NSAIDs and disease-modifying antirheumatic drugs in subjects with RA Actions on performance of dextropropoxyphene ( DXP ) alone and in combination with amitriptyline ( AMI ) , indomethacin ( IN ) , and placebo were compared in 15 patients with rheumatoid arthritis . The patients were on their prescribed maintenance regimen excluding analgesics . In four r and omized test sessions at two-week intervals , they received double blind and crossover single oral doses of DXP 130 mg , IN 50 mg , DXP 65 mg + AMI 25 mg or placebo , each after two days ' pretreatment with the same drug . Objective and subjective effects were measured at baseline and 2 and 4 hours after drug administration . DXP impaired critical flicker discrimination , symbol copying and body balance without modifying tracking , choice reactions or attention . It rendered the subjects elated , muzzy , mentally slow and calm . Actions of AMI + DXP were about the same . IN impaired body balance and critical flicker recognition . Plasma concentrations of DXP were moderate to high whilst those of IN and AMI were fairly low . We conclude that therapeutic doses of DXP and IN are relatively safe in regard to driving skills . Small doses of AMI may not enhance the mild psychomotor effects of DXP . Earlier single dose studies carried out with healthy volunteers might have overestimated the decremental effects of analgesics on psychomotor performance Severe and chronic pain is a dominant feature in most patients with rheumatoid arthritis . Despite optimum doses of st and ard analgesic and anti-inflammatory drugs , there are many patients who do not obtain adequate pain relief . Until recently , the use of strong analgesics has been strongly contraindicated , as all such available drugs were classified under the Dangerous Drugs Act ( DUdley Hart , 1968 ) . The risk of drug dependence in patients with a chronic disease such as rheumatoid arthritis clearly precludes the use of such drugs except in exceptional circumstances . The development of a new group of narcotic antagonists with a benzomorphan nucleus ( Archer , Albertson , Harris , Pierson , Bird , Keats , Telford , and Papadopoulos , 1962 ) led to the introduction of pentazocine in 1967 . When given by intramuscular or subcutaneous injection , 30 mg . pentazocine is approximately equinanalgesic with 10 mg . morphine ( British Medical Journal , Today 's Drugs , 1970 ) . The W.H.O. Expert Committee on Drug Dependence have passed pentazocine as being safe for use without special controls on three occasions ( W.H.O. Technical Reports , 1966 , 1969 , 1970 ) . It has been widely used for the relief of postoperative pain ( Kantor , Sunshine , Laska , Meisner , and Hopper , 1966 ) in the management of patients with malignant dis-ase ( Beaver , Wallenstein , Houde , and Rogers , 1968 ; Frankendal and Kjellgren , 1971 ) , ischaemic heart ( Scott and Orr , 1969 ) and limb pain ( Taylor , 1971 ) , and in obstetric practice ( Mitchell , 1963 ; Filler and Filler , 1966 ) . In two uncontrolled trials ( Vignon , Chapuy , and Falconnet , 1969 ; DavidChausse and Laporte , 1970 ) , it was suggested that injections of pentazocine in doses ranging from 30 to 120 mg . per day were highly effective in patients with a variety of rheumatic diseases . The marketing of an oral preparation in 1969 made it possible to consider the use of pentazocine as a practical possibility in the long-term management of rheumatoid arthritis , although it was found to be only one-third as effective as the parenteral preparation on clinical assessment ( Beaver , 1968 ) and on monitoring blood levels ( Beckett , Taylor , and Kourounakis , 1970 ) . In considering the use of pentazocine for the treatment of rheumatoid arthritis , it is unlikely that it would be an effective form of therapy on its own . It possesses no anti-inflammatory or antipyretic activity ( Sterling Winthrop Laboratories , Unpublished observations ) . Fremont-Smith and Bayles ( 1965 ) showed that even large doses of pethidine were less effective than salicylates in relieving symptoms in active rheumatoid arthritis , and it is generally accepted that , if adequate analgesia is to be obtained , drugs combining peripheral anti-inflammatory , analgesic , and antipyretic effects must be employed ( Winter , 1966 ; Drug Ther . Bull . , 1966 ) . In this paper , we report the results of a doubleblind cross-over trial in which oral pentazocine and identical placebo tablets were given to patients who were receiving st and ard and stable regimes of nonsteroidal analgesic anti-inflammatory drugs but were obtaining inadequate relief of pain A series of experiments has been carried out with single doses of simple analgesics in patients with rheumatoid arthritis using a consistent polyad design . This method proved to be both valid and useful . Pain relief scores were a better measure of the effectiveness of analgesics than preference . Aspirin , Codis , and Distalgesic were the most effective analgesics tested , with paracetamol , pentazocine , and Ciba 44,328 intermediate between these agents and placebo . Placebo given after an active analgesic was more effective than when given before ; this phenomenon was not abolished by telling the patients that apparently identical tablets were , in fact , different or by making them different in colour . The effectiveness of soluble placebo depended on its colour , red being the most effective
Output:
| There was no difference between opioids and placebo in net efficacy after adjustment for AE .
Based on 11 heterogeneous studies of short duration and high risk of bias , there is weak evidence that opioids are effective analgesics in RA . |
MS211430 | ***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 companion diagnostic assay was codeveloped by Dako for pembrolizumab non – small-cell lung cancer clinical trials to detect PD-L1 expression by immunohistochemistry ( IHC ) . This automated IHC assay has been analytically verified and vali date d using Dako ’s autostainer Link 48 and 22C3 mouse anti-PD-L1 monoclonal antibody to detect the PD-L1 expression in formalin-fixed paraffin-embedded human tumor tissue specimens . The PD-L1 22C3 IHC assay was optimized for high sensitivity and specificity . Repeatability and reproducibility studies were conducted at Dako and at 3 Clinical Laboratory Improvement Amendments certified laboratories during assay development . The studies included : intersite and intrasite , interobserver and intraobserver , interinstrument , interoperator , interday , and interlot , and intraday and intrarun . All precision studies performed at Dako and external laboratories achieved > 85 % point-estimate agreements for all 3 agreement types ( negative , positive , and overall ) . A clinical cutoff ( tumor proportion score ≥50 % ) of PD-L1 expression was determined and evaluated through a phase 1 clinical trial ( KEYNOTE-001 ) for advanced non – small-cell lung cancer patients treated with pembrolizumab . The treatment effect of pembrolizumab in the 61 subjects who had a tumor PD-L1 of tumor proportion score ≥50 % was substantial , with an overall response rate of 41 % ( 95 % confidence interval , 28.6 - 54.3 ) as compared with 20.6 % ( 95 % confidence interval , 15.5 - 26.5 ) observed in the 223 subjects irrespective of PD-L1 status . PD-L1 IHC 22C3 pharmDx is a sensitive , precise , and robust companion diagnostic assay , which will facilitate safe and effective use for pembrolizumab in cancer patients BACKGROUND In the phase 3 KEYNOTE-024 trial , treatment with pembrolizumab conferred longer progression-free survival than did platinum-based therapy in patients with treatment-naive , advanced non-small-cell lung cancer ( NSCLC ) with a programmed cell death-lig and 1 ( PD-L1 ) tumour proportion score of 50 % or greater ( PD-L1-positive ) . Here we report the prespecified exploratory endpoint of pembrolizumab versus chemotherapy on patient-reported outcomes ( PROs ) . METHODS In this multicentre , international , r and omised , open-label , phase 3 trial , we recruited patients with treatment-naive , stage IV NSCLC in 102 sites in 16 countries . Eligible patients had measurable disease ( per RECIST version 1.1 ) and an Eastern Cooperative Oncology Group ( ECOG ) performance status 0 or 1 . Patients were r and omly assigned ( 1:1 ) via an interactive voice response system and integrated web response system to receive either pembrolizumab 200 mg every 3 weeks ( 35 cycles ) or investigator-choice platinum-doublet chemotherapy ( 4 - 6 cycles or until documented disease progression or unacceptable toxicity ) . R and omisation was stratified according to geography , ECOG performance status , and histology . PROs were assessed at day 1 of cycles 1 - 3 , every 9 weeks thereafter , at the treatment discontinuation visit , and at the 30-day safety assessment visit using the European Organisation for the Research and Treatment of Cancer ( EORTC ) Quality of Life Question naire Core 30 items ( QLQ-C30 ) , the EORTC Quality of Life Question naire Lung Cancer 13 items ( QLQ-LC13 ) , and the European Quality of Life 5 Dimensions-3 Level ( EQ-5D-3L ) question naire . The key exploratory PRO endpoints ( analysed for all patients who received at least one dose of study treatment and completed at least one PRO instrument at at least one timepoint ) were baseline-to-week-15 change in the QLQ-C30 global health status (GHS)/ quality -of-life ( QOL ) score and time to deterioration of the composite of cough , chest pain , and dyspnoea in the QLQ-LC13 . This study is registered with Clinical Trials.gov , number NCT02142738 , and is ongoing but no longer enrolling patients . FINDINGS Between Sept 19 , 2014 , and Oct 29 , 2015 , 305 patients were r and omly assigned to pembrolizumab ( n=154 ) or chemotherapy ( n=151 ) . Three patients in each group did not complete any PRO instruments at any timepoints , and so 299 patients were included in the full analysis set . Of these patients , one in each group did not complete any PRO instruments before week 15 , and so were not included in analyses of change from baseline to week 15 . PRO compliance was greater than 90 % at baseline and approximately 80 % at week 15 for both groups . Least-squares mean baseline-to-week-15 change in QLQ-C30 GHS/QOL score was 6·9 ( 95 % CI 3·3 to 10·6 ) for pembrolizumab and -0·9 ( -4·8 to 3·0 ) for chemotherapy , for a difference of 7·8 ( 2·9 to 12·8 ; two-sided nominal p=0·0020 ) . Fewer pembrolizumab-treated patients had deterioration in the QLQ-LC13 composite endpoint than did chemotherapy-treated patients ( 46 [ 31 % ] of 151 patients vs 58 [ 39 % ] of 148 patients ) . Time to deterioration was longer with pembrolizumab than with chemotherapy ( median not reached [ 95 % CI 8·5 to not reached ] vs 5·0 months [ 3·6 to not reached ] ; hazard ratio 0·66 , 95 % CI 0·44 - 0·97 ; two-sided nominal p=0·029 ) . INTERPRETATION Pembrolizumab improves or maintains health-related QOL compared with that for chemotherapy , and might represent a new first-line st and ard of care for PD-L1-expressing , advanced NSCLC . FUNDING Merck & BACKGROUND Limited evidence exists to show that adding a third agent to platinum-doublet chemotherapy improves efficacy in the first-line advanced non-small-cell lung cancer ( NSCLC ) setting . The anti-PD-1 antibody pembrolizumab has shown efficacy as monotherapy in patients with advanced NSCLC and has a non-overlapping toxicity profile with chemotherapy . We assessed whether the addition of pembrolizumab to platinum-doublet chemotherapy improves efficacy in patients with advanced non-squamous NSCLC . METHODS In this r and omised , open-label , phase 2 cohort of a multicohort study ( KEYNOTE-021 ) , patients were enrolled at 26 medical centres in the USA and Taiwan . Patients with chemotherapy-naive , stage IIIB or IV , non-squamous NSCLC without targetable EGFR or ALK genetic aberrations were r and omly assigned ( 1:1 ) in blocks of four stratified by PD-L1 tumour proportion score ( < 1 % vs ≥1 % ) using an interactive voice-response system to 4 cycles of pembrolizumab 200 mg plus carboplatin area under curve 5 mg/mL per min and pemetrexed 500 mg/m2 every 3 weeks followed by pembrolizumab for 24 months and indefinite pemetrexed maintenance therapy or to 4 cycles of carboplatin and pemetrexed alone followed by indefinite pemetrexed maintenance therapy . The primary endpoint was the proportion of patients who achieved an objective response , defined as the percentage of patients with radiologically confirmed complete or partial response according to Response Evaluation Criteria in Solid Tumors version 1.1 assessed by masked , independent central review , in the intention-to-treat population , defined as all patients who were allocated to study treatment . Significance threshold was p<0·025 ( one sided ) . Safety was assessed in the as-treated population , defined as all patients who received at least one dose of the assigned study treatment . This trial , which is closed for enrolment but continuing for follow-up , is registered with Clinical Trials.gov , number NCT02039674 . FINDINGS Between Nov 25 , 2014 , and Jan 25 , 2016 , 123 patients were enrolled ; 60 were r and omly assigned to the pembrolizumab plus chemotherapy group and 63 to the chemotherapy alone group . 33 ( 55 % ; 95 % CI 42 - 68 ) of 60 patients in the pembrolizumab plus chemotherapy group achieved an objective response compared with 18 ( 29 % ; 18 - 41 ) of 63 patients in the chemotherapy alone group ( estimated treatment difference 26 % [ 95 % CI 9 - 42 % ] ; p=0·0016 ) . The incidence of grade 3 or worse treatment-related adverse events was similar between groups ( 23 [ 39 % ] of 59 patients in the pembrolizumab plus chemotherapy group and 16 [ 26 % ] of 62 in the chemotherapy alone group ) . The most common grade 3 or worse treatment-related adverse events in the pembrolizumab plus chemotherapy group were anaemia ( seven [ 12 % ] of 59 ) and decreased neutrophil count ( three [ 5 % ] ) ; an additional six events each occurred in two ( 3 % ) for acute kidney injury , decreased lymphocyte count , fatigue , neutropenia , and sepsis , and thrombocytopenia . In the chemotherapy alone group , the most common grade 3 or worse events were anaemia ( nine [ 15 % ] of 62 ) and decreased neutrophil count , pancytopenia , and thrombocytopenia ( two [ 3 % ] each ) . One ( 2 % ) of 59 patients in the pembrolizumab plus chemotherapy group experienced treatment-related death because of sepsis compared with two ( 3 % ) of 62 patients in the chemotherapy group : one because of sepsis and one because of pancytopenia . INTERPRETATION Combination of pembrolizumab , carboplatin , and pemetrexed could be an effective and tolerable first-line treatment option for patients with advanced non-squamous NSCLC . This finding is being further explored in an ongoing international , r and omised , double-blind , phase 3 study . FUNDING Merck & Purpose Patients with squamous non-small-cell lung cancer ( NSCLC ) have poor prognosis and limited treatment options . This r and omized , double-blind , phase III study investigated the efficacy and safety of first-line ipilimumab or placebo plus paclitaxel and carboplatin in advanced squamous NSCLC . Patients and Methods Patients with stage IV or recurrent chemotherapy-naïve squamous NSCLC were r and omly assigned ( 1:1 ) to receive paclitaxel and carboplatin plus blinded ipilimumab 10 mg/kg or placebo every 3 weeks on a phased induction schedule comprising six chemotherapy cycles , with ipilimumab or placebo from cycles 3 to 6 and then , after induction treatment , ipilimumab or placebo maintenance every 12 weeks for patients with stable disease or better . The primary end point was overall survival ( OS ) in patients receiving at least one dose of blinded study therapy . Results Of 956 r and omly assigned patients , 749 received at least one dose of blinded study therapy ( chemotherapy plus ipilimumab , n = 388 ; chemotherapy plus placebo , n = 361 ) . Median OS was 13.4 months for chemotherapy plus ipilimumab and 12.4 months for chemotherapy plus placebo ( hazard ratio , 0.91 ; 95 % CI , 0.77 to 1.07 ; P = .25 ) . Median progression-free survival was 5.6 months for both groups ( hazard ratio , 0.87 ; 95 % CI , 0.75 to 1.01 ) . Rates of grade 3 or 4 treatment-related adverse events ( TRAEs ) , any- grade serious TRAEs , and TRAEs leading to discontinuation were numerically higher with chemotherapy plus ipilimumab ( 51 % , 33 % , and 28 % , respectively ) than with chemotherapy plus placebo ( 35 % , 10 % , and 7 % , respectively ) . Seven treatment-related deaths occurred with chemotherapy plus ipilimumab , and one occurred with chemotherapy plus placebo . Conclusion The addition of ipilimumab to first-line chemotherapy did not prolong OS compared with chemotherapy alone in patients with advanced squamous NSCLC . The safety profile of chemotherapy plus ipilimumab was consistent with that observed in previous lung and melanoma studies . Ongoing studies are evaluating ipilimumab in combination with nivolumab in this population BACKGROUND Nivolumab plus ipilimumab showed promising efficacy for the treatment of non – small‐cell lung cancer ( NSCLC ) in a phase 1 trial , and tumor mutational burden has emerged as a potential biomarker of benefit . In this part of an open‐label , multipart , phase 3 trial , we examined progression‐free survival with nivolumab plus ipilimumab versus chemotherapy
Output:
| Immunotherapy plus chemotherapy appeared superior to Pembrolizumab alone for PD-L1-high ( i.e. , TPS≥50 % ) NSCLC patients .
BC might also be specifically recommended as an initial first-line treatment for PD-L1-high , non-squamous NSCLC patients , since BC was not inferior to Pembrolizumab alone .
PC and ABC might be preferred for NSCLC patients with intermediate PD-L1 ( 1 % ≤PD-L1 , TPS<50 % ) expression .
BC can also be tentatively recommended specifically for PD-L1-intermediate , non-squamous NSCLC patients .
Combined immunotherapies can all be recommended for PD-L1-negative ( i.e. , TPS<1 % ) NSCLC patients , although especially the ABC combination for non-squamous NSCLC patients , which was superior to PC in regards of PFS .
However , PC performed comparable to ABC in the whole population and in all subgroup save this one . |
MS211431 | ***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 The perception that older cancer patients may be at higher risk than younger patients of toxic effects from cancer therapy but may obtain less clinical benefit from it may be based on the underrepresentation of older patients in clinical trials and the known toxic effects of cytotoxic chemotherapy . It is not known how older patients respond to targeted therapy . Methods This retrospective subgroup analysis of data from the phase 3 , r and omized Treatment Approach in Renal Cancer Global Evaluation Trial examined the safety and efficacy of sorafenib in older ( age ≥70 years , n = 115 ) and younger patients ( age < 70 years , n = 787 ) who received treatment for advanced renal cell carcinoma . Patient demographics and progression-free survival were recorded . Best tumor response , clinical benefit rate ( defined as complete response plus partial response plus stable disease ) , time to self-reported health status deterioration , and toxic effects were assessed by descriptive statistics . Health-related quality of life was assessed with a Cox proportional hazards model . Kaplan – Meier analyses were used to summarize time-to-event data . Results Median progression-free survival was similar in sorafenib-treated younger patients ( 23.9 weeks ; hazard ratio [ HR ] for progression compared with placebo = 0.55 , 95 % confidence interval [ CI ] = 0.47 to 0.66 ) and older patients ( 26.3 weeks ; HR = 0.43 , 95 % CI = 0.26 to 0.69 ) . Clinical benefit rates among younger and older sorafenib-treated patients were also similar ( 83.5 % and 84.3 % , respectively ) and were superior to those of younger and older placebo-treated patients ( 53.8 % and 62.2 % , respectively ) . Adverse events were predictable and manageable regardless of age . Sorafenib treatment delayed the time to self-reported health status deterioration among both older patients ( 121 days with sorafenib vs 85 days with placebo ; HR = 0.66 , 95 % CI = 0.43 to 1.03 ) and younger patients ( 90 days with sorafenib vs 52 days with placebo ; HR = 0.69 , 95 % CI = 0.59 to 0.81 ) and improved quality of life over that time . Conclusions Among patients with advanced renal cell carcinoma receiving sorafenib treatment , outcomes of older ( ≥70 years ) and younger ( < 70 years ) patients were similar PURPOSE The antitumor activity and safety of tivozanib , which is a potent and selective vascular endothelial growth factor receptor-1 , -2 , and -3 inhibitor , was assessed in patients with advanced/metastatic renal cell carcinoma ( RCC ) . PATIENTS AND METHODS In this phase II , r and omized discontinuation trial , 272 patients received open-label tivozanib 1.5 mg/d ( one cycle equaled three treatment weeks followed by a 1-week break ) orally for 16 weeks . Thereafter , 78 patients who demonstrated ≥ 25 % tumor shrinkage continued to take tivozanib , and 118 patients with less than 25 % tumor change were r and omly assigned to receive tivozanib or a placebo in a double-blind manner ; patients with ≥ 25 % tumor growth were discontinued . Primary end points included safety , the objective response rate ( ORR ) at 16 weeks , and the percentage of r and omly assigned patients who remained progression free after 12 weeks of double-blind treatment ; secondary end points included progression-free survival ( PFS ) . RESULTS Of 272 patients enrolled onto the study , 83 % of patients had clear-cell histology , 73 % of patients had undergone nephrectomy , and 54 % of patients were treatment naive . The ORR after 16 weeks of tivozanib treatment was 18 % ( 95 % CI , 14 % to 23 % ) . Of the 118 r and omized patients , significantly more patients who were r and omly assigned to receive double-blind tivozanib remained progression free after 12 weeks versus patients who received the placebo ( 49 % v 21 % ; P = .001 ) . Throughout the study , the ORR was 24 % ( 95 % CI , 19 % to 30 % ) , and the median PFS was 11.7 months ( 95 % CI , 8.3 to 14.3 months ) in the overall study population . The most common grade 3 and 4 treatment-related adverse event was hypertension ( 12 % ) . CONCLUSION Tivozanib was active and well tolerated in patients with advanced RCC . These data support additional development of tivozanib in advanced RCC BACKGROUND The treatment of advanced renal cell carcinoma has been revolutionised by targeted therapy with drugs that block angiogenesis . So far , no phase 3 r and omised trials comparing the effectiveness of one targeted agent against another have been reported . We did a r and omised phase 3 study comparing axitinib , a potent and selective second-generation inhibitor of vascular endothelial growth factor ( VEGF ) receptors , with sorafenib , an approved VEGF receptor inhibitor , as second-line therapy in patients with metastatic renal cell cancer . METHODS We included patients coming from 175 sites ( hospitals and outpatient clinics ) in 22 countries aged 18 years or older with confirmed renal clear-cell carcinoma who progressed despite first-line therapy containing sunitinib , bevacizumab plus interferon-alfa , temsirolimus , or cytokines . Patients were stratified according to Eastern Cooperative Oncology Group performance status and type of previous treatment and then r and omly assigned ( 1:1 ) to either axitinib ( 5 mg twice daily ) or sorafenib ( 400 mg twice daily ) . Axitinib dose increases to 7 mg and then to 10 mg , twice daily , were allowed for those patients without hypertension or adverse reactions above grade 2 . Participants were not masked to study treatment . The primary endpoint was progression-free survival ( PFS ) and was assessed by a masked , independent radiology review and analysed by intention to treat . This trial was registered on Clinical Trials.gov , number NCT00678392 . FINDINGS A total of 723 patients were enrolled and r and omly assigned to receive axitinib ( n=361 ) or sorafenib ( n=362 ) . The median PFS was 6·7 months with axitinib compared to 4·7 months with sorafenib ( hazard ratio 0·665 ; 95 % CI 0·544 - 0·812 ; one-sided p<0·0001 ) . Treatment was discontinued because of toxic effects in 14 ( 4 % ) of 359 patients treated with axitinib and 29 ( 8 % ) of 355 patients treated with sorafenib . The most common adverse events were diarrhoea , hypertension , and fatigue in the axitinib arm , and diarrhoea , palmar-plantar erythrodysaesthesia , and alopecia in the sorafenib arm . INTERPRETATION Axitinib result ed in significantly longer PFS compared with sorafenib . Axitinib is a treatment option for second-line therapy of advanced renal cell carcinoma . FUNDING Pfizer BACKGROUND Cediranib is a highly potent vascular endothelial growth factor ( VEGF ) signalling inhibitor with activity against VEGF receptors 1 , 2 and 3 . This Phase II , r and omised , double-blind , parallel-group study compared the efficacy of cediranib with placebo in patients with metastatic or recurrent clear cell renal cell carcinoma who had not previously received a VEGF signalling inhibitor . METHODS Patients were r and omised ( 3:1 ) to cediranib 45 mg/day or placebo . The primary objective was comparison of change from baseline in tumour size after 12 weeks of therapy . Secondary objectives included response rate and duration , progression-free survival ( PFS ) and safety and tolerability . Patients in the placebo group could cross over to open-label cediranib at 12 weeks or earlier if their disease had progressed . This study has been completed and is registered with Clinical Trials.gov , number NCT00423332 . FINDINGS Patients ( n=71 ) were r and omised to receive cediranib ( n=53 ) or placebo ( n=18 ) . The primary study outcome revealed that , after 12weeks of therapy , there was a significant difference in mean percentage change from baseline in tumour size between the cediranib ( -20 % ) and placebo ( + 20 % ) arms ( p<0.0001 ) . Eighteen patients ( 34 % ) on cediranib achieved a partial response and 25 ( 47 % ) experienced stable disease . Cediranib treatment prolonged PFS significantly compared with placebo ( hazard ratio (HR)=0.45 , 90%confidence interval : 0.26 - 0.76 , p=0.017 ; median PFS 12.1 versus 2.8 months ) . The most common adverse events in patients receiving cediranib were diarrhoea ( 74 % ) , hypertension ( 64 % ) , fatigue ( 58 % ) and dysphonia ( 58 % ) . INTERPRETATION Cediranib monotherapy demonstrated significant evidence of antitumour activity in patients with advanced renal cell carcinoma . The adverse event profile was consistent with previous studies of cediranib 45 mg Background : Since PI3K/AKT/mTOR pathway activation diminishes the effects of hormone therapy , combining aromatase inhibitors ( anatrozole ) with mTOR inhibitors ( everolimus ) was investigated . Patients and Methods : We evaluated anastrozole and everolimus in 55 patients with metastatic estrogen ( ER ) and /or progesterone receptor (PR)-positive breast and gynecologic tumors . Endpoints were safety , antitumor activity and molecular correlates . Results : Full doses of anastrozole ( 1 mg PO daily ) and everolimus ( 10 mg PO daily ) were well tolerated . Twelve of 50 evaluable patients ( 24 % ) ( median = 3 prior therapies ) achieved stable disease ( SD ) ≥ 6 months/partial response (PR)/complete response ( CR ) ( n = 5 ( 10 % ) with PR/CR ) : 9 of 32 ( 28 % ) with breast cancer ( n=5 ( 16 % ) with PR/CR ) ; 2 of 10 ( 20 % ) , ovarian cancer ; and 1 of 6 ( 17 % ) , endometrial cancer . Six of 22 patients ( 27 % ) with molecular alterations in the PI3K/AKT/mTOR pathway achieved SD ≥ 6 months/PR/CR . Six of 8 patients ( 75 % ) with SD ≥ 6 months/PR/CR with molecular testing demonstrated at least one alteration in the PI3K/AKT/mTOR pathway : mutations in PIK3CA ( n=3 ) and AKT1 ( n=1 ) or PTEN loss ( n=3 ) . All three responders ( CR ( n = 1 ) ; PR ( n=2 ) ) who had next generation sequencing demonstrated additional alterations : amplifications in CCNE1 , IRS2 , MCL1 , CCND1 , FGFR1 and MYC and a rearrangement in PRKDC . Conclusions : Combination anastrozole and everolimus is well tolerated at full approved doses , and is active in heavily-pretreated patients with ER and /or PR-positive breast , ovarian and endometrial cancers . Responses were observed in patients with multiple molecular aberrations . Clinical Trails Included : BACKGROUND Combining targeted treatments for renal cell carcinoma has been suggested as a possible method to improve treatment efficacy . We aim ed to assess the potential synergistic or additive effect of the combination of bevacizumab , directed against the VEGF receptor , and temsirolimus , an mTOR inhibitor , in metastatic renal cell carcinoma . METHODS TORAVA was an open-label , multicentre r and omised phase 2 study undertaken in 24 centres in France . Patients aged 18 years or older who had untreated metastatic renal cell carcinoma were r and omly assigned ( 2:1:1 ) to receive the combination of bevacizumab ( 10 mg/kg every 2 weeks ) and temsirolimus ( 25 mg weekly ; group A ) , or one of the st and ard treatments : sunitinib ( 50 mg/day for 4 weeks followed by 2 weeks off ; group B ) , or the combination of interferon alfa ( 9 mIU three times per week ) and bevacizumab ( 10 mg/kg every 2 weeks ; group C ) . R and omisation was done central ly and independently from other study procedures with computer-generated permuted blocks of four and eight patients stratified by participating centre and Eastern Cooperative Oncology Group performance status . The primary endpoint was progression-free survival ( PFS ) at 48 weeks ( four follow-up CT scans ) , which was expected to be above 50 % in group A. Analysis was by intention to treat . The study is ongoing for long-term overall survival . This study is registered with Clinical Trials.gov , number NCT00619268 . FINDINGS Between March 3 , 2008 and May
Output:
| Compared with placebo and IFN-α , single vascular epithelial growth factor ( receptor ) tyrosine kinase inhibitor and mammalian target of rapamycin agent ( VEGF(r)-TKI & mTOR inhibitor ) were associated with improved PFS , improved OS and higher ORR , respectively .
Comparing sorafenib combination vs sorafenib , there was no significant difference with regard to PFS and OS , but with a higher ORR .
Comparing single or combination VEGF(r)-TKI & mTOR inhibitor vs BEV + IFN-α , there was no significant difference with regard to PFS , OS , or ORR .
Our network ITC meta- analysis also indicated a superior PFS of axitinib and everolimus compared to sorafenib .
Our data suggest that targeted therapy with VEGF(r)-TKI & mTOR inhibitor is associated with superior efficacy for treating advanced RCC with improved PFS , OS and higher ORR compared to placebo and IFN-α .
In summary , here we give a comprehensive overview of current targeted therapies of advanced RCC that may provide evidence for the adequate targeted therapy selecting |
MS211432 | ***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: PURPOSE To evaluate the effectiveness of home temperature monitoring to reduce the incidence of foot ulcers in high-risk patients with diabetes . METHODS In this physician-blinded , 18-month r and omized controlled trial , 225 subjects with diabetes at high risk for ulceration were assigned to st and ard therapy ( St and ard Therapy Group ) or dermal thermometry ( Dermal Thermometry Group ) groups . Both groups received therapeutic footwear , diabetic foot education , regular foot care , and performed a structured foot inspection daily . Dermal Thermometry Group subjects used an infrared skin thermometer to measure temperatures on 6 foot sites twice daily . Temperature differences > 4 degrees F between left and right corresponding sites triggered patients to contact the study nurse and reduce activity until temperatures normalized . RESULTS A total of 8.4 % ( n=19 ) subjects ulcerated over the study period . Subjects were one third as likely to ulcerate in the Dermal Thermometry Group compared with the St and ard Therapy Group ( 12.2 % vs 4.7 % , odds ratio 3.0 , 95 % confidence interval , 1.0 to 8.5 , P=.038 ) . Proportional hazards regression analysis suggested that thermometry intervention was associated with a significantly longer time to ulceration ( P=.04 ) , adjusted for elevated foot ulcer classification ( International Working Group Risk Factor 3 ) , age , and minority status . Patients that ulcerated had a temperature difference that was 4.8 times greater at the site of ulceration in the week before ulceration than did a r and om 7 consecutive-day sample of 50 other subjects that did not ulcerate ( 3.50+/-1.0 vs 0.74+/-0.05 , P=.001 ) . CONCLUSIONS High temperature gradients between feet may predict the onset of neuropathic ulceration and self-monitoring may reduce the risk of ulceration Abstract Aims /hypothesisThis observer-blind , r and omised controlled trial was design ed to determine the effect of a foot care education programme in the secondary prevention of foot ulcers . Methods People with newly healed foot ulcers attending one of three specialist clinics were allocated to receive either targeted , one-to-one education or usual care , using a computer-generated r and om allocation sequence that had been prepared in advance but which was concealed from the clinical research er . The primary outcome was ulcer incidence at 12 months . Secondary outcomes were ulcer incidence at 6 months and incidence of amputation , mood ( Hospital Anxiety and Depression Scale ) and quality of life ( Diabetic Foot Ulcer Scale ) at 6 and 12 months . Protective foot care behaviours ( Nottingham Assessment of Functional Footcare ) were assessed at 12 months . Results There were 87 ( mean [ SD ] age 63.5 [ 12.1 ] years ) patients in the intervention group and 85 control patients ( mean [ SD ] age 64.9 [ 10.9 ] years ) . The groups were comparable at baseline . No significant differences ( p > 0.05 ) were observed between groups in ulcer incidence at either 6 months ( intervention 30 % , control 21 % ) or 12 months ( intervention 41 % , control 41 % ) . Recommended foot care behaviours at 12 months were better in the intervention than in the control group ( p = 0.03 ) , but education had no significant ( p > 0.05 ) effect on mood , quality of life or amputations . Conclusions /interpretationEven though the intervention was associated with improved foot care behaviour , there was no evidence that this programme of targeted education was associated with clinical benefit in this population when compared with usual care . The usefulness and optimal delivery of education to such a high-risk group requires further evaluation . Trial registration : Clinical Trials.gov NCT00729456 Funding : Diabetes UK project grant The purpose of this study was to evaluate the effectiveness of the activities of a podiatrist in the outpatient foot care of patients with diabetes . Patients from southwestern Finl and , ages 10 to 80 years , were selected from the national diabetes register . Those without a recent visit to a podiatrist and without any obvious need for foot care ( n=530 ) were r and omized into a podiatric care group ( individual counseling and primary prevention measures , n=267 ) and a control group ( written instructions only , n=263 ) . Knowledge of foot care and self-care habits were evaluated by means of structured interviews , and a podiatric examination was performed at baseline and 1 and 7 years later . Compared with the baseline scores , the knowledge score was higher at the 7-year follow-up in both the podiatric and control group and similarly in men and women . Self-care score increased in men similarly in both treatment groups . The self-care score for women increased more in the podiatric group during the first year and the difference between the groups remained for up to 7 years . There were no significant differences between the groups in the podiatric findings OBJECTIVE —The purpose of this study was to evaluate the effectiveness of a temperature monitoring instrument to reduce the incidence of foot ulcers in individuals with diabetes who have a high risk for lower extremity complications . RESEARCH DESIGN AND METHODS —In this physician-blinded , r and omized , 15-month , multicenter trial , 173 subjects with a previous history of diabetic foot ulceration were assigned to st and ard therapy , structured foot examination , or enhanced therapy groups . Each group received therapeutic footwear , diabetic foot education , and regular foot care . Subjects in the structured foot examination group performed a structured foot inspection daily and recorded their findings in a logbook . If st and ard therapy or structured foot examinations identified any foot abnormalities , subjects were instructed to contact the study nurse immediately . Subjects in the enhanced therapy group used an infrared skin thermometer to measure temperatures on six foot sites each day . Temperature differences > 4 ° F ( > 2.2 ° C ) between left and right corresponding sites triggered patients to contact the study nurse and reduce activity until temperatures normalized . RESULTS —The enhanced therapy group had fewer foot ulcers than the st and ard therapy and structured foot examination groups ( enhanced therapy 8.5 vs. st and ard therapy 29.3 % , P = 0.0046 and enhanced therapy vs. structured foot examination 30.4 % , P = 0.0029 ) . Patients in the st and ard therapy and structured foot examination groups were 4.37 and 4.71 times more likely to develop ulcers than patients in the enhanced therapy group . CONCLUSIONS —Infrared temperature home monitoring , in serving as an “ early warning sign , ” appears to be a simple and useful adjunct in the prevention of diabetic foot ulcerations OBJECTIVE To evaluate the influence of podiatrist activities on the outpatient care of diabetic patients in terms of knowledge of diabetic foot care , self-care , and minor foot problems . RESEARCH DESIGN AND METHODS There were 733 patients , aged 10–79 years , identified from the national diabetes register . Patients without recent visits to a podiatrist and without an obvious need for foot care were r and omized into a podiatric care group ( education and primary prevention measures , n = 267 ) and a control group ( written instructions only , n = 263 ) . The patients were examined by an independent study podiatrist at baseline and after 1 year . RESULTS Patients in the podiatrist group had greater improvement in knowledge of diabetic foot care ( P = 0.004 ) and self-care ( P < 0.001 ) scores compared with control subjects . The prevalence of callosities in regions other than the calcaneal region decreased more ( P = 0.009 ) in the podiatrist group ( from 54.5 to 39.5 % ) than in the control group ( from 51.3 to 48.2 % ) , and the size of the callosities decreased more ( P < 0.001 ) in the podiatrist group than in the control group . Reduction in the prevalence of callosities was associated with younger age ( < 50 years ) . CONCLUSIONS Education and primary preventive measures provided individually by a podiatrist result in significant improvements in knowledge and foot self-care scores and in improvements in the prevalence of some minor foot problems . Long-term studies are needed to evaluate whether the intervention of podiatrists starting at an early phase would lead to a reduction in major foot problems Objective . The objective of this study was to assess the impact of a structured follow-up program on the incidence of diabetic foot ulceration ( DFU ) in high-risk diabetic patients . Research Design and Methods . A total of 1874 diabetic patients referred to the Diabetic Foot Unit of the University of Pisa were ranked based on the ulcerative risk score proposed by the International Consensus on Diabetic Foot . Out of 334 patients ( 17.8 % ) with a score ≥2 , 298 accepted to participate in this prospect i ve trial and were r and omized into 2 groups : group A , which received st and ard treatment , and group B , in which the patients received , as a part of a structured prevention program , custom-made orthesis and shoes . Incidence of new DFUs was observed for no less than 1 year and in a subset of patients after 3 and 5 years , respectively . Incidence of new DFUs and recurrences were considered as primary endpoints to establish the effectiveness of the program ; costs were also compared . Results . Among the patients enrolled in this follow-up analysis , 46 % had neuropathy and deformities , 20 % had previous ulceration , 25 % had previous minor amputation , and 9 % had neuro-osteoarthropathy . During the first 12-month follow-up , 11.5 % of patients in group B developed a DFU compared with 38.6 % in group A ( P < .0001 ) . In the extended follow-up , the cumulative incidence of ulcer in group B compared with group A was 17.6 % versus 61 % ( P < .0001 ) after 3 years and 23.5 % versus 72 % ( P < .0001 ) after 5 years , respectively . The net balance at the end of the follow-up was highly in favor of the prevention program , with a saving of more than € 100 000 per year . Conclusions . The implementation of a structured follow-up with the use of orthesis and shoes can reduce the incidence of DFU in diabetic patients who are at high ulcerative risk and its related costs BACKGROUND AND OBJECTIVE The use of r and omized consent design s has been subject of method ologic and ethical controversy . In most Western countries , research ethics committees make the decision as to whether a r and omized consent design can be applied . The purpose of the study is to assess to what extent a r and omized consent design and a modification of this design is accepted by research ethics committees , in terms of ethics , health law , and methodology . METHODS A postal survey was conducted among members of research ethics committees in the United Kingdom , and in The Netherl and s , with professional competence in ethics , ( health ) law , methodology , or clinical practice . RESULTS In both the UK and in The Netherl and s , the modified r and omized consent design appears to be statistically significantly more acceptable than the r and omized consent design , with respect to ethical and judicial aspects . The overall rejection rate of the r and omized consent design was 66 % in the UK and 59 % in The Netherl and s. However , the modified r and omized consent design was rejected by 47 and 41 % in the two countries , respectively . CONCLUSION the modified r and omized consent design appears to be more acceptable than the r and omized consent design . To increase consistency in the way research ethics committees h and le study protocol s , a discussion about the use of r and omized consent design s appears necessary The Consoli date d St and ards of Reporting Trials ( CONSORT ) statement was developed to improve the reporting of r and omised controlled trials . It was initially published in 1996 and focused on the reporting of parallel group r and omised controlled trials . The statement was revised in 2001 , with a further up date in 2010 . A separate CONSORT statement for the reporting of abstract s was published in 2008 . In earlier papers we considered the implication s of the 2001 version of the CONSORT statement for the reporting of cluster r and omised trial . In this paper we provide up date d and extended guidance , based on the 2010 version of the CONSORT statement and the 2008 CONSORT statement for the reporting of abstract s. Participants who received Pies Sanos , a 15-min intervention design ed to improve diabetes self-efficacy and foot self-care behaviors in adult patients with type 2 diabetes who lived in a predominantly Mexican American community , performed more-complete foot self-care 1 month later in their homes . Recruited when they presented for nonurgent care to the emergency department in two community hospitals near the U.S .— Mexico border , participants were r and omized into one of three groups . At follow-up , there was a significant difference in observed foot self-care behaviors between groups , F(2 , 135 ) = 2.99 , p < .05 , as well as a significant difference within the intervention , t ( 47 ) = −4.32 , p < .01 , and control group , t ( 46 ) = −2.06 , p < .05 , for baseline and follow-up self-reported foot self-care behaviors . Baseline diabetes self-efficacy was significantly and positively correlated with both baseline ( r = .335 , p < .001 ) and follow-up ( r = .174 , p < .05 ) foot self-care behaviors OBJECTIVE To evaluate the influence of regular chiropodist
Output:
| There is no high- quality research evidence evaluating complex interventions for preventing diabetic foot ulceration and insufficient evidence of benefit |
MS211433 | ***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: A prospect i ve r and omized trial evaluated grade d-compression antiembolism stockings for prevention of leg vein thrombosis as assessed by Doppler ultrasound , in patients undergoing total hip replacement . The study was terminated after the evaluation of 18 patients revealed a significantly greater incidence of deep vein thrombosis , documented by phlebography , in patients without stockings ( 5 of 10 ) compared to those with stockings ( none of 8 , p less than 0.03 ) . Three of the patients with thrombosis developed pulmonary emboli . Although the sample size of this study is small , the implication that grade d-compression stockings reduce the incidence of leg vein thrombosis is strong and is supported by the results of other recent trials . These findings are at variance with earlier studies which failed to document efficacy of elastic stockings , which involved products which did not provide grade d limb compression We studied 80 patients who were older than 50 years of age to determine if grade d elastic compression stockings reduced the frequency of postoperative thrombosis in patients undergoing dextran 70 prophylaxis . All of the patients received a total of 2,000 mL of dextran 70 during three days ; according to a r and om table , each of the patients had one leg encased in a grade d compression stocking for one week . Thrombosis development was screened with the fibrinogen I 125 test . Eight patients manifested thrombosis-one in the thigh and seven in the calf -- localized to the unstockinged leg , a frequency significantly greater than the zero frequency in the stockinged leg . No untoward effects of this combination prophylaxis were noted A study of 95 patients determined the incidence of postoperative venous thrombosis and the effectiveness of simple prophylactic measures . In addition , the accuracy of the radioactive fibrinogen technique for the detection of thrombosis was compared to venography . Deep venous thrombosis was detected in six of 44 ( 14 % ) control patients . However , only two of 51 ( 4 % ) patients on whom prophylactic measures were applied developed thrombosis . The ages of the patients with thrombosis occurring postoperatively were significantly higher than the ages of the other patients in this study . There was an excellent correlation of the results obtained by the radioactive method with those of venography . Laboratory tests indicated a deficient endogenous fibrinolytic activity in those patients who developed thrombosis In a prospect i ve , r and omized study on 114 patients undergoing major abdominal surgery , the prophylactic effect of dihydroergotamine ( DHE ) combined with low-dose heparin ( LDH ) against postoperative deep vein thrombosis ( DVT ) was compared with that of peroperative intermittent pneumatic calf compression ( IPCC ) . The additive effect of graduated pressure stockings was also studied , by r and omizing a stocking to the right or left leg in each patient . The 125I-fibrinogen test was used to diagnose DVT . The incidence of postoperative DVT was significantly lower in the DHE-LDH than in the IPCC group ( 4 % v. 19 % ) . In the IPCC group the incidence of postoperative DVT was equal in legs with and without stocking . The study thus indicated that DHE-LDH is more effective than peroperative IPCC in preventing DVT after major abdominal surgery , and that graduated pressure stockings do not enhance the prophylactic effect of peroperative IPCC Totally , 150 patients , subjected to total hip arthroplasty , were r and omly allocated into three prophylactic groups with either conventional dextran alone or with additional grade d compression stockings or with additional preoperative administration of dextran . The overall frequency of deep venous thrombosis ( DVT ) , as studied by radioactive fibrinogen uptake test and ascending phlebography of the operated on thigh was in the conventional dextran group 46 percent , the additional stockinged group 30 percent , and in the additional preoperative dextran group 52 percent . In the stockinged group , there was a lower frequency of DVT in the nonoperated on leg as well as , on an average , about 350 mL less peroperative bleeding as compared with the other two groups . No adverse reaction occurred from dextran administration . Increased and prolonged postoperative administration of dextran decrease the number of femoral DVTs Seventy-eight patients having elective total hip replacement were r and omised into 3 groups A ) control ; B ) low molecular weight heparin : ( enoxaparin 40 mg once daily ) and C ) enoxaparin ( 40 mg once daily ) plus graduated elastic compression ( TEDR stockings ) for 8 - 12 days . All patients had a preoperative perfusion lung scan and chest X-Ray and a postoperative perfusion/ventilation scan together with bilateral ascending venography on days 8 - 12 . A blood sample was taken preoperatively , on the 1st , 3rd and 5th postoperative day and at the end of the study . The control group received placebo injections . The venograms and V/Q scans were reported blindly by an independent panel of three and one radiologists respectively . An independent panel of assessors stopped entry in the control group when a total of 45 patients were admitted according to Ethics Committee directives . The study continued with groups B and C. The incidence of DVT ( including isolated asymptomatic calf thrombi ) was as follows : Group A ( n = 14 ) 93 % ; Group B ( n = 32 ) 38 % ; Group C ( n = 32 ) 25 % ( chi 2 ; p < 0.001 for group A versus B or C ) . The incidence of proximal DVT was : Group A 57 % ; group B 28 % ; group C 13 % ( chi 2 ; p = 0.057 for group A versus B and p < 0.005 for group A versus C ) . The incidence of silent pulmonary embolism ( PE ) ( new defect on V/Q scan ) was 28 % ( 8 out of 29 ) in patients with and 5 % ( 2 out of 43 ) in patients without DVT ( chi 2 ; p < 0.02 ) . The combination of high TAT and low anti-Xa activity on the 1st postoperative day identified a high risk group of patients who had a 56 % incidence of proximal DVT on the 8th to 12th postoperative day . Further studies are needed to confirm the suggested increased efficacy in prophylaxis by the combination of LMWH and GEC as compared with LMWH alone Little is known about the efficacy of graduated compression stockings in preventing venous thromboembolism after hip surgery . We conducted a prospect i ve , r and omised single-blind study to determine whether the addition of compression stockings to fondaparinux conferred any additional benefit . The study included 874 patients , of whom 795 could be evaluated ( 400 in the fondaparinux group and 395 in the fondaparinux plus compression stocking group ) . Fondaparinux was given post-operatively for five to nine days , either alone or combined with wearing stockings , which were worn for a mean 42 days ( 35 to 49 ) . The study outcomes were venous thromboembolism , or sudden death before day 42 . Duplex ultrasonography was scheduled within a week of day 42 . Safety outcomes were bleeding and death from venous thromboembolism . The prevalence of deep-vein thrombosis was similar in the two groups 5.5 % ( 22 of 400 ) in the fondaparinux group and 4.8 ( 19 of 395 ) in the fondaparinux plus stocking group ( odds ratio 0.88 , 95 % confidence interval 0.46 to 1.65 , p = 0.69 ) . Major bleeding occurred in only one patient . The addition of graduated compression stockings to fondaparinux appears to offer no additional benefit over the use of fondaparinux alone Background Nurses on an Acute Care Evidence Based Practice Committee , creating a policy to increase patient compliance with thromboembolic deterrent stockings ( TEDS ) and sequential compression devices ( SCDs ) for deep vein thrombosis prophylaxis , found limited literature on patient preference and response to this treatment . Study Aim The study purpose was to determine whether knee-length or thigh-length TEDS and /or SCDs were more comfortable , correctly applied , and worn by patients , and to assess patient reasons for noncompliance . Method A patient survey and observational data tool was design ed . Six surveyors collected data ( interrater reliability = 93 % ) from 137 r and omly selected patients with orders for TEDS and /or SCDs admitted to acute care medical or surgical nursing units . Results Most patients wore thigh-length SCDs and TEDS . However , only 29.2 % ( n = 40 ) had SCDs on them at the time of survey , and 62.8 % ( n = 86 ) were compliant with TEDS . The most common reasons given for noncompliance with SCDs were that the devices were not reapplied after bathing or ambulating , or were removed because they were hot or itchy . Complaints of discomfort were highest among patients wearing thigh-length SCDs and TEDS . Problems with fit were 50 % higher in those who wore thigh-length TEDS , and involved stockings that created restricting b and s. Most patients understood the purpose of treatment , and older patients were more compliant than younger patients . Implication s for Practice Knee-length TEDS and SCDs are more comfortable for patients , encourage higher levels of compliance with treatment , do not pose a risk for venous stasis to patients by creating restricting b and s , and are less expensive . Patients need ongoing education to resume wearing TEDS and SCDs after activities of daily living , and knee-length stockings and devices would be easier to reapply . The policy in our institution was changed for the use of knee-length compression stockings and SCDs The mechanisms by which graduated compression stockings prevent deep venous thrombosis are not completely understood . In the current study the physiologic effect of low-pressure graduated compression stockings on the venous blood flow in the lower limb and the practical aspects of their use were assessed . Patients having elective orthopaedic surgery at a university orthopaedic department were r and omized into five groups to wear two different types of graduated compression stockings in thigh and knee lengths . Patients in the fifth control group did not wear graduated compression stockings . Venous occlusion strain gauge plethysmography was used to measure venous flow . After 20-minutes bed rest there was a highly significant increase in venous capacitance and venous outflow in patients in all of the four groups wearing stockings . There was no difference in the mean of the percentage change of venous capacitance in patients in the four groups wearing stockings . The knee length Brevet stockings were less efficient in increasing the venous outflow . There was no significant change in the venous capacitance and venous outflow in patients in the control group . Visual assessment of the fit and use of stockings was done , and patients ’ subjective opinion of comfort was sought . The knee length graduated compression stockings wrinkled significantly less , and significantly fewer patients reported discomfort with them . All stockings were reported to be difficult to use . Thigh and knee length stockings have a significant effect on decreasing venous stasis of the lower limb . Knee length graduated compression stockings are similarly efficient in decreasing venous stasis , but they are more comfortable to wear , and they wrinkle less The frequency of deep venous thrombosis ( DVT ) was studied in 98 patients undergoing major abdominal surgery . All the patients received low dose heparin prophylaxis 5000 i.u . every 12 h for 5–7 days . In each patient , a graduated compression stocking was also worn and r and omly allocated to one of the legs and the other leg served as a control . DVT was diagnosed by the 125I‐fibrinogen method . Four patients developed bilateral DVT and 8 patients unilateral DVT , all of whom developed it in the control leg . The difference in unilateral DVT between stockinged and control legs was significant ( P < 0·004 ) . It is concluded that a combination of low dose heparin and graduated compression stockings is more effective than low dose heparin alone in reducing the frequency of postoperative DVT . It is suggested that this combination of prophylaxis might be of value in high risk patients This was a r and omized clinical trial to determine the efficacy and safety of a ‘ blanket ’ protocol of low molecular weight heparin ( LMWH ) and the best length of antiembolism stocking , for every patient requiring surgery under general anaesthesia OBJECTIVE To compare knee-length with thigh-length graduated compression stockings for correct application and rate of compliance when they are prescribed for the prevention of deep-vein thrombosis in surgical patients . METHODOLOGY Patients who were prescribed graduated compression stockings were prospect ively studied in three surgical units at Groote Schuur Hospital from February to June 1997 . Knee-length stockings were prescribed in the colorectal unit , while the thigh-length variety were prescribed in the hepatobiliary and trauma units . Patients were observed for the correct application and size of stockings , and the presence of compression b and s. A total of 72 patients were studied . RESULTS One patient in the knee-length group and 7 patients in the thigh-length group were not wearing their stockings . Twenty-one of 30 patients ( 70 % ) in the knee-length group and 15 of 42 ( 35.7 % ) in the thigh-length group had correctly applied stockings ( P = 0.009 ) . CONCLUSIONS Knee-length are more likely to be correctly applied than thigh-length stockings . Knee-length should replace thigh-length stockings in general surgical patients Two hundred and
Output:
| CONCLUSIONS Thigh length stockings may be more effective than knee length stockings , but results did not reach statistical significance and the evidence base is weak .
While thigh length stockings appear to have superior efficacy , practical issues such as patient acceptability may prevent their wide use in clinical practice . |
MS211434 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
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Input: The US National Institute of Neurological Disorders and Stroke convened major stakeholders in June 2012 to discuss how to improve the method ological reporting of animal studies in grant applications and publications . The main workshop recommendation is that at a minimum studies should report on sample -size estimation , whether and how animals were r and omized , whether investigators were blind to the treatment , and the h and ling of data . We recognize that achieving a meaningful improvement in the quality of reporting will require a concerted effort by investigators , review ers , funding agencies and journal editors . Requiring better reporting of animal studies will raise awareness of the importance of rigorous study design to accelerate scientific progress The localization of substance P in brain regions that coordinate stress responses and receive convergent monoaminergic innervation suggested that substance P antagonists might have psychotherapeutic properties . Like clinical ly used antidepressant and anxiolytic drugs , substance P antagonists suppressed isolation-induced vocalizations in guinea pigs . In a placebo-controlled trial in patients with moderate to severe major depression , robust antidepressant effects of the substance P antagonist MK-869 were consistently observed . In pre clinical studies , substance P antagonists did not interact with monoamine systems in the manner seen with established antidepressant drugs . These findings suggest that substance P may play an important role in psychiatric disorders The pharmacological properties of two NK1 antagonists were studied in comparison with a benzodiazepine during a 7 % CO2 challenge in a population of healthy volunteers selected for a high sensitivity to the challenge . In total , 19 healthy subjects , pre-screened for their responsiveness to the 7 % CO2 test , took part in the r and omised , double-blind , cross-over , incomplete block design study . After receiving treatment or placebo , the volunteers were subjected to three 7 % CO2 challenges each for a time of 20 min . The treatment consisted of the administration of the following three active drugs : a single dose of benzodiazepine alprazolam ( 0.75 mg ) and a single dose of the NK1 antagonists vestipitant ( GW597599 ) ( 15 mg ) and vofopitant ( GR205171 ) ( 25 mg ) . Anxiety during the challenge was evaluated with Visual Analogue Scale-Anxiety ( VAS-A ) and with Panic Symptom List ( PSL III-R ) . Respiratory parameters , heart rate and skin conductance were also recorded . Compared with placebo , vestipitant showed a significant reduction ( p<0.05 ) in anxiety assessed on the VAS-A scale ( ΔVAS-A% ) while alprazolam significantly ( p<0.01 ) attenuated the PSL III-R total score . Vofopitant did not show any anxiolytic effect . In the comparison analysis between placebo and drugs , none of the respiratory and other physiological parameters showed a statistically significant difference The effects of flesinoxan , a potent and selective 5-HT1A agonist , were studied in two pilot studies in panic disorder patients to explore the role of 5-HT1A receptors in the mechanism of action of antipanic agents . This paper reports on the results of these two studies with flesinoxan . In study I , using a single-blind crossover design , five patients were treated for 1 week with placebo , 4 weeks with flesinoxan ( up to 2.4 mg per day ) , and 2 weeks with placebo . In study II , 15 patients were enrolled in a double-blind , three-armed study with placebo and two dosages of flesinoxan . After a single-blind placebo run-in phase of 1 week , patients were treated for 8 weeks with placebo , 0.6 or 1.2 mg/day flesinoxan . In pilot study I patients ’ condition worsened during the 4-week flesinoxan treatment period . Anxiety was frequently reported as an adverse event . Symptoms returned to the pre-treatment level during the 2-week placebo washout period . In pilot study II , no treatment effects in either group were observed . Anxiety as an adverse event was less prominent than in the first pilot study . A lowering of mood was seen in some patients . The sample sizes of these two pilot studies are too small to draw firm conclusions on the efficacy of flesinoxan in panic disorder , but the present data are not encouraging in this respect . The worsening of symptoms seen with the highest dose of flesinoxan is intriguing and might give a clue to the underst and ing of the mechanism underlying similar effects seen with antidepressants in panic disorder patients The neuropeptide substance P and its receptor NK1 have been implicated in emotion , anxiety and stress in pre clinical studies . However , the role of NK1 receptors in human brain function is less clear and there have been inconsistent reports of the value of NK1 receptor antagonists in the treatment of clinical depression . The present study therefore aim ed to investigate effects of NK1 antagonism on the neural processing of emotional information in healthy volunteers . Twenty-four participants were r and omized to receive a single dose of aprepitant ( 125 mg ) or placebo . Approximately 4 h later , neural responses during facial expression processing and an emotional counting Stroop word task were assessed using fMRI . Mood and subjective experience were also measured using self-report scales . As expected a single dose of aprepitant did not affect mood and subjective state in the healthy volunteers . However , NK1 antagonism increased responses specifically during the presentation of happy facial expressions in both the rostral anterior cingulate and the right amygdala . In the emotional counting Stroop task the aprepitant group had increased activation in both the medial orbitofrontal cortex and the precuneus cortex to positive vs. neutral words . These results suggest consistent effects of NK1 antagonism on neural responses to positive affective information in two different paradigms . Such findings confirm animal studies which support a role for NK1 receptors in emotion . Such an approach may be useful in underst and ing the effects of novel drug treatments prior to full-scale clinical trials Background Systematic Review s ( SRs ) of experimental animal studies are not yet common practice , but awareness of the merits of conducting such SRs is steadily increasing . As animal intervention studies differ from r and omized clinical trials ( RCT ) in many aspects , the methodology for SRs of clinical trials needs to be adapted and optimized for animal intervention studies . The Cochrane Collaboration developed a Risk of Bias ( RoB ) tool to establish consistency and avoid discrepancies in assessing the method ological quality of RCTs . A similar initiative is warranted in the field of animal experimentation . Methods We provide an RoB tool for animal intervention studies ( SYRCLE ’s RoB tool ) . This tool is based on the Cochrane RoB tool and has been adjusted for aspects of bias that play a specific role in animal intervention studies . To enhance transparency and applicability , we formulated signalling questions to facilitate judgment . Results The result ing RoB tool for animal studies contains 10 entries . These entries are related to selection bias , performance bias , detection bias , attrition bias , reporting bias and other biases . Half these items are in agreement with the items in the Cochrane RoB tool . Most of the variations between the two tools are due to differences in design between RCTs and animal studies . Shortcomings in , or unfamiliarity with , specific aspects of experimental design of animal studies compared to clinical studies also play a role . Conclusions SYRCLE ’s RoB tool is an adapted version of the Cochrane RoB tool . Widespread adoption and implementation of this tool will facilitate and improve critical appraisal of evidence from animal studies . This may subsequently enhance the efficiency of translating animal research into clinical practice and increase awareness of the necessity of improving the method ological quality of animal studies
Output:
| Meta- analysis showed that the different drug classes in clinical use for the treatment of anxiety disorders , have comparable effects on vocalization behaviour , irrespective of their mechanism of action .
Of the experimental drugs , nociception ( NOP ) receptor agonists proved very effective in this test .
With regard to method ological characteristics , repeated testing of pups as well as selecting pups with moderate or high levels of vocalization were associated with larger treatment effects . |
MS211435 | ***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 Sleep disturbance is highly prevalent among veterans . As an alternative to sleep medications with their undesirable side effects , nonpharmacological mind-body interventions may be beneficial for sleep management in primary care . The aim of this pilot study was to investigate whether a novel mind-body intervention , mind-body bridging ( MBB ) , focusing on sleep , could improve self-reported sleep disturbance and comorbid symptoms in veterans . METHODS This pilot study was a r and omized controlled trial at the Veterans Affairs Salt Lake City Health Care System in which 63 veterans with self-reported sleep disturbance received MBB or an active sleep education control . Both interventions were conducted in two sessions , once per week . Patient-reported outcomes included the following : primary -Medical Outcomes Study ( MOS ) Sleep Survey , MOS Short Form-36V ; secondary -Center for Epidemiological Studies -Depression , PTSD Check List-Military , Five-Factor Mindfulness Question naire . RESULTS At both Week 1 ( 1 week after the first session ) and post-intervention assessment s , while sleep disturbance decreased in both groups , MBB performed significantly better than did the control group . Furthermore , self-reported PTSD symptoms improved in MBB , while they remained unchanged in the control . Overall mindfulness increased in MBB , while it remained unchanged in the control . CONCLUSIONS This study provides preliminary evidence that a brief sleep-focused MBB could be a promising intervention for sleep and potentially other comorbid symptoms ( e.g. , PTSD ) . MBB could help patients develop awareness skills to deal with sleep-related symptoms . Integration of MBB into primary care setting s may enhance care of patients with sleep disturbance and co-morbid symptoms This article describes a second treatment- outcome study of cognitive trauma therapy for battered women with posttraumatic stress disorder ( PTSD ; CTT-BW ) . CTT-BW includes trauma history exploration : PTSD education ; stress management ; exposure to abuse and abuser reminders ; self-monitoring of negative self-talk ; cognitive therapy for guilt ; and modules on self-advocacy , assertiveness , and how to identify perpetrators . One hundred twenty-five ethnically diverse women were r and omly assigned to immediate or delayed CTT-BW . PTSD remitted in 87 % of women who completed CTT-BW , with large reductions in depression and guilt and substantial increases in self-esteem . White and ethnic minority women benefited equally from CTT-BW . Similar treatment outcomes were obtained by male and female therapists and by therapists with different levels of education and training . Gains were maintained at 3- and 6-month follow-ups Abstract This study examined the effect of Emotional Freedom Techniques ( EFT ) , a brief exposure therapy combining cognitive and somatic elements , on posttraumatic stress disorder ( PTSD ) and psychological distress symptoms in veterans receiving mental health services . Veterans meeting the clinical criteria for PTSD were r and omized to EFT ( n = 30 ) or st and ard of care wait list ( SOC/WL ; n = 29 ) . The EFT intervention consisted of 6-hour – long EFT coaching sessions concurrent with st and ard care . The SOC/WL and EFT groups were compared before and after the intervention ( at 1 month for the SOC/WL group and after six sessions for the EFT group ) . The EFT subjects had significantly reduced psychological distress ( p < 0.0012 ) and PTSD symptom levels ( p < 0.0001 ) after the test . In addition , 90 % of the EFT group no longer met PTSD clinical criteria , compared with 4 % in the SOC/WL group . After the wait period , the SOC/WL subjects received EFT . In a within-subjects longitudinal analysis , 60 % no longer met the PTSD clinical criteria after three sessions . This increased to 86 % after six sessions for the 49 subjects who ultimately received EFT and remained at 86 % at 3 months and at 80 % at 6 months . The results are consistent with that of other published reports showing EFT ’s efficacy in treating PTSD and comorbid symptoms and its long-term effects BACKGROUND Little is known about the effect of pharmacotherapy in the prevention of post-traumatic stress disorder ( PTSD ) relapse . AIMS To assess the efficacy and tolerability of fluoxetine in preventing PTSD relapse . METHOD This was a double-blind , r and omised , placebo-controlled study . Following 12 weeks of acute treatment , patients who responded were rer and omised and continued in a 24-week relapse prevention phase with fluoxetine ( n=69 ) or placebo ( n=62 ) . The primary efficacy assessment was the prevention of PTSD relapse , based on the time to relapse . RESULTS Patients in the fluoxetine/fluoxetine group were less likely to relapse than patients in the fluoxetine/placebo group ( P=0.027 ) . There were no clinical ly significant differences in treatment-emergent adverse events between treatment groups . CONCLUSIONS Fluoxetine is effective and well tolerated in the prevention of PTSD relapse for up to 6 months BACKGROUND Unlike civilian post-traumatic stress disorder ( PTSD ) , the efficacy of sertraline for the treatment of combat-related PTSD has not yet been proven . The present study aim ed to evaluate the clinical efficacy of sertraline against combat-related PTSD in a r and omized , double-blind , placebo-controlled trial . METHOD Seventy Iranian veterans of the Iran-Iraq war who met the DSM-IV criteria for diagnosis of PTSD were r and omized to receive either flexibly dosed sertraline ( 50 - 200 mg/day ) ( n=35 , completers=32 ) or placebo ( n=35 , completers=30 ) for 10 weeks . Efficacy was evaluated by the Impact of Event Scale -- Revised ( IES-R ) and the Clinical Global Impression scale -- Severity ( CGI-S ) and Improvement ( CGI-I ) ratings . Responder criteria were defined as a ≥30 % reduction in the IES-R total score plus a CGI-I rating of ' much ' or ' very much ' improved . RESULTS On both intention-to-treat ( ITT ) and per protocol ( completer ) methods of analysis , the mean reductions in the IES-R total and subscale ( re-experiencing/intrusion , avoidance/numbing and hyperarousal ) scores ( p<0.001 ) and also in the CGI-S score ( p<0.01 ) were significantly greater in the sertraline group than in the placebo group . For the CGI-I , the mean endpoint score was significantly lower in the sertraline group than in the placebo group ( p≤0.001 ) . The number of responders in the sertraline group was significantly higher than in the placebo group ( 44 % v. 3 % , p≤0.001 ) . Sertraline was well tolerated , with a 6 % discontinuation rate as a result of adverse reactions . CONCLUSIONS The results of this study suggest that sertraline can be an effective , safe and tolerable treatment for combat-related PTSD in Iranian veterans CONTEXT No large-scale posttraumatic stress disorder drug trials have been conducted to evaluate treatment effects beyond 12 weeks outside of those with selective serotonin reuptake inhibitors . OBJECTIVE To evaluate the efficacy of venlafaxine extended release ( ER ) , a serotonin norepinephrine reuptake inhibitor , in posttraumatic stress disorder . DESIGN 6-month , double-blind , placebo-controlled trial . SETTING International study at 56 sites . Patients Adult out patients ( N = 329 ) with a primary diagnosis of posttraumatic stress disorder as defined in the DSM-IV , symptoms for 6 months or longer , and a 17-item Clinician-Administered Posttraumatic Stress Disorder Scale score of 60 or higher . Intervention Patients r and omly assigned to receive flexible doses of venlafaxine ER ( 37.5 - 300 mg/d ) or placebo for 24 weeks . MAIN OUTCOME MEASURES Primary measure was the change from baseline in the Clinician-Administered Posttraumatic Stress Disorder Scale score . Secondary measures included remission , defined as a Clinician-Administered Posttraumatic Stress Disorder Scale score of 20 or lower , and changes in symptom cluster scores , frequency of remission , and time to remission . Measures of stress vulnerability , resilience , depression , quality of life , functioning , and global illness severity were also taken . RESULTS Mean changes from baseline in Clinician-Administered Posttraumatic Stress Disorder Scale total scores at end point were -51.7 for venlafaxine ER and -43.9 for placebo ( P = .006 ) . Improvement was significantly greater for the venlafaxine ER group than for the placebo group in cluster scores for reexperiencing ( P = .008 ) and avoidance/numbing ( P = .006 ) , but not for hyperarousal . Remission rates were 50.9 % for venlafaxine ER and 37.5 % for placebo ( P = .01 ) . The venlafaxine ER group also showed significantly greater improvement at end point than the placebo group ( P<.05 ) on all other reported outcome measures . The mean maximum daily dose of venlafaxine ER was 221.5 mg/d . Withdrawal rates were similar between groups with no significant difference in dropouts attributable to adverse events . CONCLUSION In this study , venlafaxine ER was effective and well tolerated in short-term and continuation treatment of patients with posttraumatic stress disorder IMPORTANCE Alcohol dependence comorbid with posttraumatic stress disorder ( PTSD ) has been found to be resistant to treatment . In addition , there is a concern that prolonged exposure therapy for PTSD may exacerbate alcohol use . OBJECTIVE To compare the efficacy of an evidence -based treatment for alcohol dependence ( naltrexone ) plus an evidence -based treatment for PTSD ( prolonged exposure therapy ) , their combination , and supportive counseling . DESIGN , SETTING , AND PARTICIPANTS A single-blind , r and omized clinical trial of 165 participants with PTSD and alcohol dependence conducted at the University of Pennsylvania and the Philadelphia Veterans Administration . Participant enrollment began on February 8 , 2001 , and ended on June 25 , 2009 . Data collection was completed on August 12 , 2010 . INTERVENTIONS Participants were r and omly assigned to ( 1 ) prolonged exposure therapy plus naltrexone ( 100 mg/d ) , ( 2 ) prolonged exposure therapy plus pill placebo , ( 3 ) supportive counseling plus naltrexone ( 100 mg/d ) , or ( 4 ) supportive counseling plus pill placebo . Prolonged exposure therapy was composed of 12 weekly 90-minute sessions followed by 6 biweekly sessions . All participants received supportive counseling . MAIN OUTCOMES AND MEASURES The Timeline Follow-Back Interview and the PTSD Symptom Severity Interview were used to assess the percentage of days drinking alcohol and PTSD severity , respectively , and the Penn Alcohol Craving Scale was used to assess alcohol craving . Independent evaluations occurred prior to treatment ( week 0 ) , at posttreatment ( week 24 ) , and at 6 months after treatment discontinuation ( week 52 ) . RESULTS Participants in all 4 treatment groups had large reductions in the percentage of days drinking ( mean change , -63.9 % [ 95 % CI , -73.6 % to -54.2 % ] for prolonged exposure therapy plus naltrexone ; -63.9 % [ 95 % CI , -73.9 % to -53.8 % ] for prolonged exposure therapy plus placebo ; -69.9 % [ 95 % CI , -78.7 % to -61.2 % ] for supportive counseling plus naltrexone ; and -61.0 % [ 95 % CI , -68.9 % to -53.0 % ] for supportive counseling plus placebo ) . However , those who received naltrexone had lower percentages of days drinking than those who received placebo ( mean difference , 7.93 % ; P = .008 ) . There was also a reduction in PTSD symptoms in all 4 groups , but the main effect of prolonged exposure therapy was not statistically significant . Six months after the end of treatment , participants in all 4 groups had increases in percentage of days drinking . However , those in the prolonged exposure therapy plus naltrexone group had the smallest increases . CONCLUSIONS AND RELEVANCE In this study of patients with alcohol dependence and PTSD , naltrexone treatment result ed in a decrease in the percentage of days drinking . Prolonged exposure therapy was not associated with an exacerbation of alcohol use disorder . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00006489 A cognitive-behavioral therapy ( CBT ) program for posttraumatic stress disorder ( PTSD ) was developed to address its high prevalence in persons with severe mental illness receiving treatment at community mental health centers . CBT was compared with treatment as usual ( TAU ) in a r and omized controlled trial with 108 clients with PTSD and either major mood disorder ( 85 % ) or schizophrenia or schizoaffective disorder ( 15 % ) , of whom 25 % also had border
Output:
| The E-TRIP provides a comprehensive assessment of prior PTSD treatments that should prove valuable for research ers study ing TR-PTSD and evaluating the efficacy of new treatments for patients with PTSD . |
MS211436 | ***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: IMPORTANCE Cigarette smoking leads to upregulation of nicotinic acetylcholine receptors ( nAChRs ) in the human brain , including the common α4β2 * nAChR subtype . While subjective aspects of tobacco dependence have been extensively examined as predictors of quitting smoking with treatment , no studies to our knowledge have yet reported the relationship between the extent of pretreatment upregulation of nAChRs and smoking cessation . OBJECTIVE To determine whether the degree of nAChR upregulation in smokers predicts quitting with a st and ard course of treatment . DESIGN , SETTING , AND PARTICIPANTS Eighty-one tobacco-dependent cigarette smokers ( volunteer sample ) underwent positron emission tomographic ( PET ) scanning of the brain with the radiotracer 2-FA followed by 10 weeks of double-blind , placebo-controlled treatment with nicotine patch ( r and om assignment ) . Pretreatment specific binding volume of distribution ( VS/fP ) on PET images ( a value that is proportional to α4β2 * nAChR availability ) was determined for 8 brain regions of interest , and participant-reported ratings of nicotine dependence , craving , and self-efficacy were collected . Relationships between these pretreatment measures , treatment type , and outcome were then determined . The study took place at academic PET and clinical research centers . MAIN OUTCOMES AND MEASURES Posttreatment quit status after treatment , defined as a participant report of 7 or more days of continuous abstinence and an exhaled carbon monoxide level of 3 ppm or less . RESULTS Smokers with lower pretreatment VS/fP values ( a potential marker of less severe nAChR upregulation ) across all brain regions studied were more likely to quit smoking ( multivariate analysis of covariance , F8,69 = 4.5 ; P < .001 ) , regardless of treatment group assignment . Furthermore , pretreatment average VS/fP values provided additional predictive power for likelihood of quitting beyond the self-report measures ( stepwise binary logistic regression , likelihood ratio χ21 = 19.8 ; P < .001 ) . CONCLUSIONS AND RELEVANCE Smokers with less upregulation of available α4β2 * nAChRs have a greater likelihood of quitting with treatment than smokers with more upregulation . In addition , the biological marker studied here provided additional predictive power beyond subjectively rated measures known to be associated with smoking cessation outcome . While the costly , time-consuming PET procedure used here is not likely to be used clinical ly , simpler methods for examining α4β2 * nAChR upregulation could be tested and applied in the future to help determine which smokers need more intensive and /or lengthier treatment . TRIAL REGISTRATION clinical trials.gov Identifier : NCT01526005 INTRODUCTION Ex vivo storage phosphor imaging rat studies reported increased brain dopamine D2/3 receptor ( DRD2/3 ) availability following treatment with varenicline , a nicotinergic drug . However , ex vivo studies can only be performed using cross-sectional design s. Small-animal imaging offers the opportunity to perform serial assessment s. We evaluated whether high-resolution pinhole single photon emission computed tomography ( SPECT ) imaging in rats was able to reproduce previous ex vivo findings . METHODS Rats were imaged for baseline striatal DRD2/3 availability using ultra-high-resolution pinhole SPECT ( U-SPECT-II ) and [123I]IBZM as a radiotracer , and r and omized to varenicline ( n=7 ; 2 mg/kg ) or saline ( n=7 ) . Following 2 weeks of treatment , a second scan was acquired . RESULTS Significantly increased striatal DRD2/3 availability was found following varenicline treatment compared to saline ( time⁎treatment effect ) : posttreatment difference in binding potential between groups corrected for initial baseline differences was 2.039 ( P=.022 ) , indicating a large effect size ( d=1.48 ) . CONCLUSIONS Ultra-high-resolution pinhole SPECT can be used to assess varenicline-induced changes in DRD2/3 availability in small laboratory animals over time . Future small-animal studies should include imaging techniques to enable repeated within-subjects measurements and reduce the amount of animals While the combination therapy of varenicline and sustained release bupropion ( bupropion SR ) for cigarette smoking cessation can increase smoking abstinence rates , it has also been associated with increases in self-reported depressive symptoms . We conducted an analysis of the Beck Depression Inventory , second edition ( BDI-II ) , data completed by 505 patients from a large r and omized clinical trial , evaluating the efficacy of 12 weeks of combination therapy ( varenicline+bupropion SR ) compared to varenicline alone . At medication treatment week 2 ( 1 week after target quit date [ TQD ] ) , increased depressive symptoms were observed in patients receiving combination therapy ( effect estimate=0.61 , 95 % CI [ 0.03 , 1.19 ] , P=.039 ) and those with a history of depression ( effect estimate=0.82 , 95 % CI [ 0.07 , 1.57 ] , P=.033 ) . For treatment weeks 2 to 4 , smokers with a history of depression on combination therapy had a greater decline in depressive symptoms compared to those on varenicline alone ( effect estimate=-1.99 , 95 % CI [ -3.99 , 0.00 ] , P=.050 ) . After treatment week 4 , no significant effects of treatment or depression history on BDI-II scores were observed . A history of depression did not moderate the efficacy of combination therapy for smoking abstinence . Our study suggests that for combination therapy with varenicline and bupropion SR , an increase in depressive symptoms over the first 2 weeks may be observed ; however , the effects on depressive symptoms do not last beyond 4 weeks . We conclude that among smokers without active moderate or severe depression , the decision to use this combination treatment approach should not be based upon a self-reported history of depression IMPORTANCE Combining pharmacotherapies for tobacco-dependence treatment may increase smoking abstinence . OBJECTIVE To determine efficacy and safety of varenicline and bupropion sustained-release ( SR ; combination therapy ) compared with varenicline ( monotherapy ) in cigarette smokers . DESIGN , SETTING , AND PARTICIPANTS R and omized , blinded , placebo-controlled multicenter clinical trial with a 12-week treatment period and follow-up through week 52 conducted between October 2009 and April 2013 at 3 midwestern clinical research sites . Five hundred six adult ( ≥18 years ) cigarette smokers were r and omly assigned and 315 ( 62 % ) completed the study . INTERVENTIONS Twelve weeks of varenicline and bupropion SR or varenicline and placebo . MAIN OUTCOMES AND MEASURES Primary outcome was abstinence rates at week 12 , defined as prolonged ( no smoking from 2 weeks after the target quit date ) abstinence and 7-day point-prevalence ( no smoking past 7 days ) abstinence . Secondary outcomes were prolonged and point-prevalence smoking abstinence rates at weeks 26 and 52 . Outcomes were biochemically confirmed . RESULTS At 12 weeks , 53.0 % of the combination therapy group achieved prolonged smoking abstinence and 56.2 % achieved 7-day point-prevalence smoking abstinence compared with 43.2 % and 48.6 % in varenicline monotherapy ( odds ratio [ OR ] , 1.49 ; 95 % CI , 1.05 - 2.12 ; P = .03 and OR , 1.36 ; 95 % CI , 0.95 - 1.93 ; P = .09 , respectively ) . At 26 weeks , 36.6 % of the combination therapy group achieved prolonged and 38.2 % achieved 7-day point-prevalence smoking abstinence compared with 27.6 % and 31.9 % in varenicline monotherapy ( OR , 1.52 ; 95 % CI , 1.04 - 2.22 ; P = .03 and OR , 1.32 ; 95 % CI , 0.91 - 1.91 ; P = .14 , respectively ) . At 52 weeks , 30.9 % of the combination therapy group achieved prolonged and 36.6 % achieved 7-day point-prevalence smoking abstinence compared with 24.5 % and 29.2 % in varenicline monotherapy ( OR , 1.39 ; 95 % CI , 0.93 - 2.07 ; P = .11 and OR , 1.40 ; 95 % CI , 0.96 - 2.05 ; P = .08 , respectively ) . Participants receiving combination therapy reported more anxiety ( 7.2 % vs 3.1 % ; P = .04 ) and depressive symptoms ( 3.6 % vs 0.8 % ; P = .03 ) . CONCLUSIONS AND RELEVANCE Among cigarette smokers , combined use of varenicline and bupropion , compared with varenicline alone , increased prolonged abstinence but not 7-day point prevalence at 12 and 26 weeks . Neither outcome was significantly different at 52 weeks . Further research is required to determine the role of combination therapy in smoking cessation . TRIAL REGISTRATION clinical trials.gov Identifier : http:// clinical trials.gov/show/NCT00935818 BACKGROUND Sex differences in addictive disorders have been described . Pre clinical studies have implicated the striatal dopamine system in these differences , but human studies have yet to substantiate these findings . METHODS Using positron emission tomography ( PET ) scans with high-specific-activity [ 11C ] raclopride and a reference tissue approach , we compared baseline striatal dopamine binding potential ( BP ) and dopamine release in men and women following amphetamine and placebo challenges . Subjective drug effects and plasma cortisol and growth hormone responses were also examined . RESULTS Although there was no sex difference in baseline BP , men had markedly greater dopamine release than women in the ventral striatum . Secondary analyses indicated that men also had greater dopamine release in three of four additional striatal regions . Paralleling the PET findings , men 's ratings of the positive effects of amphetamine were greater than women 's . We found no sex difference in neuroendocrine hormone responses . CONCLUSIONS We report for the first time a sex difference in dopamine release in humans . The robust dopamine release in men could account for increased vulnerability to stimulant use disorders and methamphetamine toxicity . Our findings indicate that future studies should control for sex and may have implication s for the interpretation of sex differences in other illnesses involving the striatum OBJECTIVE The authors assessed the efficacy and safety of combination treatment with varenicline and sustained-release bupropion for smokers who , based on an assessment of initial smoking reduction prior to the quit date , were deemed unlikely to achieve abstinence using nicotine patch treatment . METHOD In a r and omized , double-blind , parallel-group adaptive treatment trial , the authors identified 222 cigarette smokers who failed to show a reduction of more than 50 % in smoking after 1 week of nicotine patch treatment . Smokers were r and omly assigned to receive 12 weeks of varenicline plus bupropion or varenicline plus placebo . The primary outcome measure was continuous smoking abstinence at weeks 8 - 11 after the target quit date . RESULTS Both treatments were well tolerated . Participants who received the combination treatment had a significantly higher abstinence rate than those who received varenicline plus placebo ( 39.8 % compared with 25.9 % ; odds ratio=1.89 ; 95 % CI=1.07 , 3.35 ) . Combination treatment had a significantly greater effect on abstinence rate in male smokers ( odds ratio=4.26 ; 95 % CI=1.73 , 10.49 ) than in female smokers ( odds ratio=0.94 ; 95 % CI=0.43 , 2.05 ) . It also had a significantly greater effect in highly nicotine-dependent smokers ( odds ratio=3.51 , 95 % CI=1.64 , 7.51 ) than in smokers with lower levels of dependence ( odds ratio=0.71 , 95 % CI=0.28 , 1.80 ) . CONCLUSIONS Among smokers who did not show a sufficient initial response to prequit nicotine patch treatment , combination treatment with varenicline and bupropion proved more efficacious than varenicline alone for male smokers and for smokers with a high degree of nicotine dependence INTRODUCTION Varenicline and bupropion sustained release ( SR ) are both safe and effective for the treatment of tobacco dependence and have different mechanisms of action . Combination pharmacotherapy with these agents may increase long-term smoking abstinence rates above what is observed with single-agent therapy . METHODS We enrolled cigarettes smokers in an open-label , one-arm , Phase II clinical trial to obtain preliminary data on the potential effectiveness and safety of combination therapy with varenicline and bupropion SR for the treatment of tobacco dependence . Eligible subjects received varenicline titrated to 1
Output:
| Subgroup analyses suggest that this combination may be more beneficial in males and patients with higher baseline nicotine dependence .
CONCLUSION To the authors ' knowledge , this is the first review conducted to compile current literature on this novel pharmacotherapy combination for smoking cessation . |
MS211437 | ***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 test the hypothesis that commencing induction of labor in the morning more closely reflects the physiologic timing of onset of labor and is associated with fewer women who remain undelivered 24 hours after cervical ripening and induction begins . METHODS : This was a nested r and omized clinical trial , conducted between April 2001 and December 2004 . Pregnant women at more than 36 + 6 weeks gestation with a cephalic presentation who were scheduled for prostagl and in induction of labor were eligible to participate . Women were r and omly assigned to either admission in the morning ( 0800 hours ) or admission in the evening ( 2000 hours ) . The primary outcome measures were vaginal birth not achieved in 24 hours , uterine hyperstimulation with associated fetal heart rate changes , and cesarean delivery . RESULTS : A total of 620 women were entered in the trial , with 280 women in the morning admission group and 340 women in the evening admission group . There were no statistically significant differences between the timing of admission for induction and the primary trial outcomes . However , women admitted in the morning were less likely to require oxytocin infusion ( morning admission 126 of 280 [ 45.0 % ] compared with evening admission 184 of 340 [ 54.1 % ] ; relative risk 0.83 , 95 % confidence interval 0.70–0.97 ; P=.022 ) . Nulliparous women admitted in the morning were less likely to require operative vaginal birth ( morning admission 10 of 62 [ 16.1 % ] compared with evening admission 28 of 82 [ 34.2 % ] ; relative risk 0.47 , 95 % confidence interval 0.25–0.90 ; P=.015 ) . CONCLUSION : For women who require induction of labor , consideration should be given to admission in the morning rather than admission in the evening . CLINICAL TRIAL REGISTRATION : Australian Clinical Trials Registry , www.actr.org.au , 12606000156583 LEVEL OF EVIDENCE : OBJECTIVE To compare pre-induction ultrasonographic cervical length and Bishop score in predicting risk of caesarean section after labor induction with prostagl and ins . PATIENTS AND METHODS Assessment of the Bishop score and measurement of the cervical length by transvaginal sonography were performed by two operators , blinded to each other 's results among women with singleton pregnancies at between 34(+0 ) - 41(+3 ) weeks of gestation requiring induction of labor with prostagl and ins for medical indications . Fisher 's exact test and regression logistic models were used for statistics analysis . In order to measure the strength of the association between ultrasonographic cervical length or Bishop score on one h and , and the caesarean sections rate ( global or for failed induction or failure to progress ) on the other h and , we computed odds ratios with 95 % confidence interval . RESULTS Among the 266 patients included in the study , multivariate analysis has shown that only Bishop score was predictive for the global caesarean section risk ( OR [ 95 % CI ] 0.63 [ 0.45 - 0.87 ] ; P = 0.005 ) . However , neither Bishop score ( OR [ 95 % CI ] 0.68 [ 0.42 - 1.09 ] ; P = 0.11 ) , nor ultrasonographic cervical length ( OR [ 95 % CI ] 1.01 [ 0.95 - 1.08 ] ; P = 0.59 ) was predictive for failed induction or failure to progress caesarean section risk . DISCUSSION AND CONCLUSION The Bishop score appears to be a better predictor of the global caesarean section risk than ultrasonographic cervical length after induction of labor for medical reasons Objective To compare pre‐induction ultrasonographic cervical length and Bishop score in predicting time to delivery after labour induction with prostagl and ins Background Previous work by us and others had suggested that cervical electrical impedance spectroscopy ( EIS ) may be predictive of the outcome of induced labour . We sought to determine which probe configuration of the EIS device is predictive of the outcome of induced labour and compare this to digital assessment by the Bishop score . Methods In a prospect i ve cohort of 205 women admitted for induction of labour , we used four probes of diameter 3 , 6 , 9 and 12 mm connected to an impedance meter to measure cervical resistivity ( CR ) in Ohm.meters at 14 electrical frequencies and compared their values to digital assessment of the cervix by the Bishop score for the prediction of the outcome of induced labour . We tested the association of labour characteristics and outcomes with CR and Bishop score by stepwise multilinear regression analyses , and the accuracy of prediction of categorical clinical outcomes by analysis of the area under the curves ( AUC ) of derived Receiver Operator Characteristic ( ROC ) curves . Results Of the four CR probe dimensions studied , only the 12 mm probe was predictive of any labour indices . In the frequency range 19 - 156 kHz , CR obtained with this probe was higher in women who delivered by caesarean section ( CS ) than those who delivered vaginally , and in labours lasting > 24 hrs . Cervical resistivity at 78.1 kHz best predicted vaginal delivery [ optimal cut-off < 2.25 Ohm.meter , AUC 0.66 ( 95 % CI 0.59 - 0.72 ) , sensitivity 71.0 % , specificity 56.5 % , LR+ 1.63 , LR- 0.51 , P < 0.01 ] and labour duration > 24 hrs [ optimal cut-off 2.27 Ω.m , AUC 0.65 ( 95 % CI 0.58 , 0.72 ) , sensitivity 71 % , specificity 59 % , LR+ 1.72 , LR- 0.50 , P < 0.05 ] . In contrast digital assessment by the Bishop score neither predicted vaginal delivery nor the duration of labour . However , Bishop score predicted time to onset of labour > 12 hours and induction-delivery interval < 24 hrs [ optimal cut-off ≤ 4 , AUC 0.8 ( 95 % CI 0.75 , 0.86 ) , sensitivity 77 % , specificity 76 % , LR+ 3.3 , LR- 0.3 , P < 0.05 ] whilst CR did not . Conclusion Cervical resistivity appears predictive of labour duration and delivery mode following induced labour . However the low predictive values obtained suggest that its current design proffers no immediate clinical utility OBJECTIVE To compare the effectiveness of prostagl and in E(2 ) intravaginal gel with the intracervical gel in patients with an unfavorable cervix . METHOD In a prospect i ve multicenter trial 470 patients with unfavorable Bishop scores ( 3 - 4 ) were r and omized to receive prostagl and in vaginal gel ( 2 mg ) or intracervical gel ( 0.5 mg ) . RESULTS In patients with unfavorable Bishop scores the intravaginal application route result ed in a better cervical ripening , a shorter induction to delivery interval and a higher cumulative rate of deliveries during 24 h ( P=0.01 ) . CONCLUSION Intravaginal instillation of prostagl and in E(2 ) gel for induction of labor is effective in patients with an unfavorable Bishop score of 3 - 4 OBJECTIVE To compare the efficacy of low dose prostagl and in E2 vaginal tablets with that of high dose in induction of labour . DESIGN A retrospective study . SETTING Abha Maternity Hospital , a teaching hospital in the southern region of Saudia Arabia . PATIENTS The outcome of induction of labour in 73 women induced with 1.5 mg prostagl and in E2 vaginal tablets was compared with those in 168 women induced with 3 mg vaginal tablets . RESULTS There were no statistical significant differences in the success rate , induction-delivery interval , caesarean section rate and Apgar scores between the two groups . There were two incidences of uterine hyperstimulation and two of uterine rupture in the high dose group . These were not statistically significant . Logistic regression analysis showed that the success rate of induction of labour was dependent only on maternal age ( P=0.0025 ) and Bishop score ( P=-0.0403 ) and not on parity , gestational age , birthweight or dose of prostagl and in . CONCLUSION The low dose regimen of 1.5 mg is as efficacious as the high dose regimen of 3 mg prostagl and in E2 vaginal tablets in inducing labour . This implies that using the low dose regimen reduces the cost of induction of labour effectively . Larger prospect i ve r and omized studies are needed to confirm this finding AIM To examine the predictive value of previous obstetric history , Bishop score , and sonographic measurement of cervical length for predicting failed induction of labor in parous women at term . METHODS This prospect i ve observational study enrolled 110 consecutive parous women at term with singleton gestations scheduled for the induction of labor . Transvaginal ultrasound for measurement of cervical length was performed and the Bishop score was assessed using digital examination . Univariate and multivariate analyses were used for statistical analysis . RESULTS Labor induction failed in 15 women ( 14 % ) . In terms of previous obstetric history , women with only previous mid-trimester loss or preterm delivery had a significantly higher risk of failed labor induction than those with at least one previous term delivery . Logistic regression demonstrated that previous obstetric history and the Bishop score , but not cervical length , were found to be significant and independent contributing factors for failed labor induction . In the receiver operating characteristic curves , the best cut-off value of the Bishop score for the prediction of failed labor induction was 3 , with a sensitivity of 73 % and a specificity of 44 % . CONCLUSIONS The previous obstetric history ( i.e. , only previous mid-trimester loss or preterm delivery ) and the Bishop score independently predicted the failure of labor induction in parous women ; however sonographic measurement of the cervical length appeared to have a poor predictive value for the risk of failed induction Objective To evaluate maternal parity , the sonographic measurement of cervical length , and the five components of the Bishop score to determine which factors best predict the length of latent-phase labor in women undergoing labor induction . Methods Cervical position , cervical consistency , cervical effacement , cervical dilation , station of fetal presenting part , maternal parity , and sonographic measurement of cervical length were studied prospect ively in 109 women undergoing labor induction . A multiple regression model was used to determine which factors best predict the length of latent-phase labor . Results A model using these seven factors was predictive in determining the number of hours of latent-phase labor ( F = 32.1 , P < .001 ) . Backward stepwise multiple linear regression indicated that only cervical dilation independently predicted the length of latent-phase labor . There was a significant correlation between the clinical assessment of cervical effacement and the sonographic estimation of cervical length , ( r = −0.523 , P < .001 ) . Conclusion Only cervical dilation appears to predict the length of latent-phase labor . The sonographic evaluation of cervical length and maternal parity do not add significant independent information OBJECTIVE To compare transvaginal ultrasound and digital cervical examination in predicting successful induction in post‐term pregnancy . METHODS Transvaginal ultrasound and digital vaginal examinations were performed on 122 women at 41 or more weeks ' gestation , immediately before labor induction . Ultrasound assessment s of cervical length , dilatation , and presence of funneling were compared with the components of the Bishop score . The primary outcome was the rate of vaginal delivery . Secondary outcomes assessed included the rates of active labor in 12 hours , vaginal delivery in 12 and 24 hours , mean duration of latent phase , and induction to vaginal delivery interval . Linear and multiple logistic regression models were generated to identify factors independently associated with successful induction . RESULTS No ultrasound characteristic predicted primary or secondary outcomes . Bishop score ( odds ratio [ OR ] 2.98 , 95 % confidence interval [ CI ] 1.71 , 5.20 ) , cervical position ( OR 4.35 , 95 % CI 1.41 , 12.50 ) , and maternal age ( OR 1.15 , 95 % CI 1.01 , 1.30 ) independently predicted vaginal delivery . Maternal weight ( OR 0.96 , 95 % CI 0.94 , 0.98 ) , cervical dilatation ( OR 6.08 , 95 % CI 1.70 , 21.68 ) , and effacement ( OR 2.34 , 95 % CI 1.16 , 4.73 ) independently predicted active labor in 12 hours . Independent predictors of vaginal delivery in 12 hours were induction method ( P < .001 ) , cervical dilatation ( OR 11.16 , 95 % CI 3.17 , 39.29 ) , gravidity ( OR 2.06 , 95 % CI 1.13 , 3.77 ) , and maternal weight ( OR 0.96 , 95 % CI 0.93 , 0.99 ) . Cervical effacement ( OR 2.70 , 95 % CI 1.59 , 4.57 ) and parity ( OR 7.10 , 95 % CI 2.22 , 22.72 ) independently predicted vaginal delivery in 24 hours . Maternal weight , cervical position , and cervical dilatation
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| Conclusions Bishop Score seems be a determinant of achieving vaginal delivery and is associated with induction-to-vaginal delivery time interval |
MS211438 | ***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 Whether asthma morbidity in minority groups can be reduced by preventative health care measures delivered in the relevant ethnic dialects requires further evaluation . This study reports clinical outcomes and quality of life from a community based project investigating white European ( W/E ) and Indian subcontinent ( ISC ) ethnic groups with asthma living in deprived inner city areas of Birmingham , UK . METHODS Six hundred and eighty nine asthmatic subjects ( 345 W/E , 344 ISC ) of mean ( SD ) age 34.5 ( 15 ) years ( range 11–59 ) and mean forced expiratory volume in one second ( FEV1 ) of 80 % predicted were interviewed in English , Punjabi , Hindi , or Urdu . Subjects r and omised to the active limb of a prospect i ve , open , r and omised , controlled , parallel group , 12 month follow up study underwent individually based asthma education and optimisation of drug therapy with four monthly follow up ( active intervention ) . Control groups were seen only at the beginning and end of the study . Urgent or emergency interactions with primary and secondary health care ( clinical outcomes ) and both cross sectional and longitudinal data from an Asthma Quality of Life Question naire ( AQLQ ) were analysed . RESULTS Clinical outcomes were available for 593 subjects . Fewer of the active intervention group consulted their GP ( 41.8 % versus 57.8 % , odds ratio ( OR ) 0.52 ( 95 % CI 0.37 to 0.74 ) ) or were prescribed antibiotics ( 34.9 % versus 51.2 % , OR 0.51 ( 95 % CI 0.36 to 0.72 ) ) , but by ethnicity statistically significant changes occurred only in the W/E group with fewer also attending A&E departments and requiring urgent home visits . Active intervention reduced the number of hospital admissions ( 10 versus 30 ) , GP consultations ( 341 versus 476 ) , prescriptions of rescue oral steroids ( 92 versus 177 ) , and antibiotics ( 220 versus 340 ) , but again significant improvements by ethnicity only occurred in the active W/E group . AQLQ scores were negatively skewed to the higher values ; regression analysis showed that lower values were associated with ISC ethnicity . Longitudinal changes ( for 522 subjects ) in the mean AQLQ scores were small but statistically significant for both ethnic groups , with scores improving in the active and worsening in the control groups . CONCLUSIONS Active intervention only improved clinical outcomes in the W/E group . AQLQ scores , although lower in the ISC group , were improved by active intervention in both ethnic groups A prospect i ve r and omised trial was performed to evaluate the effectiveness of an asthma education programme administered by an asthma nurse specialist in an out-patient setting . Sixty asthmatic patients ( mean age 28.5 years ) were enrolled , 30 to a usual care control group and 30 to an education group . The education group underwent an individual education programme lasting at least one hour . The following variables were measured at baseline , one month after the education programme and at one year follow-up : asthma knowledge by MCQ ( 36 point question naire ) , inhaler technique ( 7 point scale ) , peak expiratory flow rate ( PEFR ) and symptomatology by visual analogue score ( 0 to 10 score ) . The education group 's inhaler technique and MCQ score both improved significantly at one month , from 5.4 ( 0.3 ) ( mean [ SEM ] ) to 6.5 ( 0.3 ) , p < 0.001 , and from 7.5 ( 2.4 ) to 22 ( 1.8 ) , p < 0.0001 respectively . Both of these improvements were significantly greater than in the control group , and both were maintained at one year follow-up . The symptom score improved over one year in the education group , from 5.4 ( 0.6 ) to 7.6 ( 0.5 ) , p < 0.05 , and was unchanged in the control group . There was no change in the PEFR in either group . This study shows clear objective benefits to an out-patient asthma education programme conducted by an asthma nurse specialist The purpose was to compare the short-term cost-effectiveness of intensive vs conventional education and supervision for the self-management of mild asthmatic patients . Consecutive newly diagnosed asthmatic patients ( n = 162 ) were r and omized into an intervention group ( IG ) and a control group ( CG ) with 1 yr of treatment and follow-up . Intensive education was given to 77 patients at visits every third month in the outpatient clinic . Eighty CG patients received conventional education and advice at the baseline visit only . All patients received similar inhaled anti-inflammatory treatment . At baseline and at 12 months st and ard clinical lung functions and health-related quality of life ( HRQOL ) were measured , the latter by the disease-specific St George 's Respiratory Question naire and the generic 15D . Furthermore , the use of extra health care services , medication and sickness days were recorded . The IG experienced a significant improvement in all clinical and HRQOL outcome variables . The same applied to the CG except spirometric values . The groups differed significantly only in terms of FEV1 ( P < 0.05 ) in favour of the IG . There was a significant difference between the groups in extra costs . The mean cost was FIM 2351 per patient ( 294 Pounds sterling ) in the CG and FIM 2757 per patient ( 345 Pounds ) in the IG , of which the intervention cost was FIM 1978 per patient ( 247 Pounds ) . In 1 yr follow-up the intensive education programme did not prove to be cost effective but was dominated by the conventional one regardless of what effectiveness measure was used . Also , a purely monetary cost-benefit calculation showed that the intervention result ed in a negative net benefit ( loss ) of FIM 406 per patient ( 51 Pounds ) . A longer follow-up may be needed before definitive conclusions about the cost-effectiveness of this kind of intervention can be drawn The effects on self management of asthma of a specially prepared book and audiocassette tape with similar contents were observed in a controlled study of 177 patients with asthma in general practice . After a run in period of six months patients were r and omly given the book , the tape , both the book and tape , or neither . Patients ' knowledge of the use of drugs , perceptions of their disability , skill in using an inhaler , consumption of drugs , consultations with their general practitioners , morbidity ( from patients ' entries on diary cards ) , and use of the educational material were measured . Knowledge about the use of drugs was significantly increased in the groups who received the material after three months and persisted after 12 months . Patients who had been given the tape or the book and tape increased their scores of knowledge of drugs more than patients given the book alone . Patients in all groups given the material considered that their disability was reduced . There were no other significant changes . Patients given both the book and the tape preferred the book . Patients with asthma can obtain useful information from such material . The paradoxical result whereby patients learnt more from the tape but preferred the book suggests that a distinction can be made between information that patients need , which may be acquired better from an audiocassette , and information that they want , which may be acquired better from a book BACKGROUND Many patients with asthma or chronic obstructive pulmonary disease use their medication inhalers incorrectly . General practitioners , pharmacists and other health care providers do not always have the opportunity to instruct patients in correct inhaler technique . OBJECTIVE To find out whether the inhaler technique and respiratory symptoms of patients can be improved after instruction by practice assistants . METHODS Single blind , r and omized intervention study in which 48 patients who had been using a dry powder inhaler for at least one month took part . Their inhaler technique was videotaped on two visits with a two-week interval between visits . The inhaler technique on the videos was subsequently scored by two experts on nine criteria . At both visits the patients completed a question naire about their respiratory symptoms . After the first video , 25 patients were r and omly chosen to receive instruction from one of six practice assistants who had followed a one evening course about inhaler instruction , and who had been issued an instruction-set . RESULTS The patients who received instruction had a significantly greater reduction in number of mistakes at the second visit than the patients who did not ( P = 0.01 ) . The instructed patients also reported less dyspnoea at the second visit ( P = 0.03 ) . No effect of instruction was found on wheezing , cough and sputum production . CONCLUSION The inhaler technique of patients can be improved significantly by the instruction of patients by trained practice assistants , possibly result ing in less dyspnoea Abstract Objectives : To evaluate the effectiveness of an asthma re source centre in improving treatment and quality of life for asthmatic patients Design : Community based r and omised controlled trial Setting : 41 general practice s in Greenwich with a practice nurse Subjects : All registered patients aged 15 - 50 years Intervention : Nurse specialists in asthma who educated and supported practice nurses , who in turn educated patients in the management of asthma according to the British Thoracic Society 's guidelines Main outcome measures : Quality of life of asthmatic patients , attendance at accident and emergency departments , admissions to local hospitals , and steroid prescribing by general practitioners Results : Of 24 400 patients r and omly selected and surveyed in 1993 , 12 238 replied ; 1621 were asthmatic of whom 1291 were sent a repeat question naire in 1996 and 780 replied . Of 24 400 patients newly surveyed in 1996 , 10 783 ( 1616 asthmatic ) replied . No evidence was found for an improvement in asthma related quality of life among newly surveyed patients in intervention practice s compared with control practice s. Neither was there evidence of an improvement in other measures of the quality of asthma care . Weak evidence was found for an improvement in quality of life in intervention practice s among asthmatics registered with study practice s in 1993 and followed up in 1996 . Neither attendances at accident and emergency departments nor admissions for asthma showed any tendency to diverge in intervention and control practice s over the study period . Steroid prescribing rates rose steadily during the study period . The average annual increase in steroid prescribing was 3 % per year higher in intervention than control practice s ( 95 % confidence interval −1 % to 6 % , P=0.10 ) Conclusions : This model of service delivery is not effective in improving the outcome of asthma in the community . Further development is required if cost effective management of asthma is to be BACKGROUND Despite improved underst and ing of the pathophysiology of asthma , morbidity and mortality continue to rise , with disproportionate increases occurring among urban , indigent minorities . New approaches in the management of asthma are therefore necessary to reverse these dramatic and costly trends . OBJECTIVE To determine if patients who are admitted to the hospital with acute asthma and receive inpatient education will have improved outpatient follow-up and clinical outcome measures compared with those receiving conventional care . METHODS Patients enrolled in the study had a primary admission diagnosis of asthma and were between ages 18 and 45 years . Exclusion criteria included comorbid disease , inability to speak English , absence of a telephone in the primary residence , or pregnancy . Seventy-seven patients admitted from the emergency department with asthma were r and omized to either the inpatient educational program ( IEP ) or routine care ( control group ) . Patients in the IEP received asthma education , bedside spirometry , a telephone call 24 hours after discharge , and scheduled follow-up in an outpatient asthma program within 1 week of discharge . Those individuals r and omized to the routine management group received conventional inpatient asthma care and routine follow-up . RESULTS The patients enrolled in the IEP had a markedly higher follow-up rate compared with outpatient appointments ( 60 % vs. 27 % ; P = .01 ) and significantly fewer emergency department visits ( P = .04 ) and hospitalizations ( P = .04 ) for asthma in the 6 months following IEP intervention , as compared with control patients . This represented a substantial cost savings to the managed care organization . CONCLUSION Our study suggests that an IEP in the treatment of indigent , inner-city patients hospitalized with asthma reduces the need for subsequent emergent care and improves outpatient follow-up in a cost-effective manner A prospect i ve controlled trial of home monitoring of peak expiratory flow rate ( PEFR ) was conducted to determine the usefulness of an objective measure of lung function in association with an education program and a medication self-management plan in reducing morbidity in adult patients with asthma . Thirty-five patients managed themselves , using peak flow readings as the basis for the therapeutic plan coupled with educational intervention , whereas 35 control patients used symptoms and spirometric data for following physicians ' treatment plans . After a 6-mo study period , patients in the experimental group showed statistically significant improvements in morbidity parameters ( days lost from work , acute asthma attacks , days on antibiotic therapy , physician consultations , and emergency room admissions for asthma ) , increases in FVC , FEV1 , and FEV1/FVC , mean PEFR and mean morning PEFR , decrease in percentage of the mean PEFR amplitude , and a reduction in the use of inhaled beta-agonists , oral theophylline , and oral prednisone . Although improvements in some of these parameters were also found in the control group , they did not reach the levels of significance obtained in the experimental group . The personal use of an objective measure of lung function in association with a medication self-management plan leads to improvement in the patient 's condition BACKGROUND Although patient education is
Output:
| Measures of lung function were little changed .
REVIEW ER 'S CONCLUSIONS Education in asthma self-management which involves self-monitoring by either peak expiratory flow or symptoms , coupled with regular medical review and a written action plan improves health outcomes for adults with asthma .
Training programmes that enable people to adjust their medication using a written action plan appear to be more effective than other forms of asthma self-management |
MS211439 | ***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 Pain reduction can be achieved by lowering proinflammatory cytokine levels in the blood . Transcutaneous electrical nerve stimulation ( TENS ) is a non-invasive physiotherapeutic re source for pain management , but evidence on the effectiveness of this device at reducing proinflammatory cytokines in the blood is unclear . This study systematic ally review s the literature on the effect of TENS on proinflammatory cytokines . Methods A systematic review protocol was developed based on search es of articles in six electronic data bases and references of retrieved articles , contact with authors , and repositories of clinical trials . Eligibility criteria : publication in peer- review ed journals , r and omized clinical trials , use of TENS in the experimental group , and pre- and post- measurements of proinflammatory cytokines in the blood . Selection of the studies and extraction of the data will be carried out by two review ers independently . Characteristics of the study , participants , interventions and outcomes were extracted and described . Assessment s were performed on the risk of bias , level of evidence and the size of the intervention effect in the studies , according to GRADE guidelines and the Cochrane H and book for Systematic Review s. Clinical and statistical assessment s compared the effects of the interventions ( meta- analysis ) , taking into consideration any influencing characteristics of the studies ( e.g. , methods and application sites ) . Discussion We anticipate that this review will strengthen evidence -based knowledge of the effect of TENS on proinflammatory cytokines and , as a result , direct new studies to benefit patients with specific pathologies . Systematic review registration PROSPERO , CRD42017060379 Background : Chronic pelvic pain is prevalent in 2 % of women population globally . The etiology is multifactorial . Even in the absence of pelvic pathology , there is a subgroup of women who do not respond to analgesic and anti-inflammatory therapy . Chronic pelvic pain can be inhibited by direct inhibition of impulses in the preganglionic afferent neuron by closing the hypothetical gate in the dorsal horn of the spinal cord . Transcutaneous electrical nerve stimulation ( TENS ) is based on the gate control theory of abolishing the painful stimuli by providing simultaneous inputs in larger myelinated nerve fibers . Aims and Objectives : This study was design ed to assess the effectiveness and safety of TENS in idiopathic chronic pelvic pain . Methods : It is a prospect i ve , experimental study to evaluate the effectiveness of TENS versus placebo in reducing pain severity in chronic pelvic pain ( G1 = 30 , G2 = 32 , G3 = 30 , and G0 = 30 ) . Patients with chronic pelvic pain due to benign lesions of genital tract , gastrointestinal , and renal disorders were excluded from the study after performing an ultrasound study of abdomen and pelvis . Ten treatment sessions ( 5 sessions/week ) of 30 min were conducted . Observations and Results : There was a significant improvement in pain scores in TENS group as compared with control group , and two patients were completely pain free following TENS therapy . Conclusion : In women patients with idiopathic chronic pelvic pain , TENS can be a useful intervention . TENS units are safe , economical , and easily commercially available In the GRADE approach , r and omized trials start as high- quality evidence and observational studies as low- quality evidence , but both can be rated down if most of the relevant evidence comes from studies that suffer from a high risk of bias . Well-established limitations of r and omized trials include failure to conceal allocation , failure to blind , loss to follow-up , and failure to appropriately consider the intention-to-treat principle . More recently recognized limitations include stopping early for apparent benefit and selective reporting of outcomes according to the results . Key limitations of observational studies include use of inappropriate controls and failure to adequately adjust for prognostic imbalance . Risk of bias may vary across outcomes ( e.g. , loss to follow-up may be far less for all-cause mortality than for quality of life ) , a consideration that many systematic review s ignore . In deciding whether to rate down for risk of bias -- whether for r and omized trials or observational studies -- authors should not take an approach that averages across studies . Rather , for any individual outcome , when there are some studies with a high risk , and some with a low risk of bias , they should consider including only the studies with a lower risk of bias OBJECTIVE To observe the effect of transcutaneous acupoint electrical stimulation ( TAES ) on plasma ET , CGRP and serum IL-6 , S100beta during craniotomy . METHODS Fifty patients scheduled for neurosurgery were r and omly divided into TAES group ( n=25 ) and control group ( n=25 ) . TAES ( 2/100 Hz , 8 - 12 mA ) of bilateral Hegu ( LI 4)-Quchi ( LI 11 ) , Zusanli ( ST 36)-Sanyinjiao ( SP 6 ) was administrated for patients of TAES group starting 30 min before anesthesia till the end of the operation . Anesthesia of the patients was maintained with sevoflurane inhalation and intermittent intravenous injection of boluses of sulfenany and vecurnium bromide . Jugular venous blood sample s were taken at preanesthesia ( T0 ) , 1 hour after craniotomy ( T1 ) , closure complete ( T2 ) , 24 hours ( T3 ) and 48 hours ( T4 ) after operation respectively for detecting contents of plasma endothelin ( ET ) , calcitonin gene-related peptide ( CGRP ) and serum interleukin (IL)-6 , S100beta with radioimmunoassay and enzyme linked immunosorbent assay separately . RESULTS Compared with control group , plasma ET at T2 , serum IL-6 at T1 S100beta at T1 and T4 in TAES group all decreased significantly ( P < 0.01 , 0.05 ) , while serum IL-6 at T3 increased remarkably ( P < 0.05 ) . It suggests that after TAES , CGRP/ET was improved , favoring cerebral microcirculation to reduce surgery-induced cerebral injury . There were no significant differences between two groups at different time courses in plasma CGRP concentrations ( P > 0.05 ) . CONCLUSION TAES can regulate plasma CGRP/ET and serum IL-6 , lower serum S100beta level , which may contribute to its effect in relieving craniotomy-induced brain injury Objective To observe the effect of electro-acupuncture ( EA ) on tumor necrosis factor-α ( TNF-α ) and vascular endothelial growth factor ( VEGF ) in peripheral blood and joint synovia in patients with rheumatoid arthritis ( RA ) to verify the clinical efficacy of EA . Methods Adopting r and omized controlled principle , the 63 RA patients enrolled were assigned to two groups , the 32 patients in the EA group were treated with EA , and the 31 patients in the simple needling ( SN ) group treated with simple needling . According to the integral-local combining method , the acupoints were selected mainly from yang-meridian and local Ashi points ( pain-point ) . EA or SN was applied every other day , 10 times as a course , and each patient received a total of 3 courses of treatment . Results Blood and synovial levels of TNF-α and VEGF were reduced significantly after treatment in both groups . The lowering ( absolute value and difference value ) of TNF-α as well as the absolute value of VEGF , either in blood or in synovia , were similar in the two groups ( P>0.05 ) ; but the lowering of VEGF after treatment was more significant in the EA group than that in the SN group ( P<0.05 ) . Conclusion EA could effectively lower the contents of TNF-α and VEGF in peripheral blood and joint synovia to improve the internal environment for genesis and development of RA , so as to enhance the clinical therapeutic effectiveness Background The postoperative period is associated with increased production of proinflammatory cytokines , which are known to augment pain sensitivity , among other effects . In a previous study , the authors found that patients treated with patient-controlled epidural analgesia ( PCEA ) exhibited attenuated proinflammatory cytokine response in the postoperative period . In the present study , the authors examined whether preemptive analgesia continued with PCEA may further attenuate the proinflammatory cytokine response and reduce pain sensitivity in the postoperative period . They compared cytokine production in two groups of patients , one receiving PCEA , the other receiving preemptive epidural analgesia continued by PCEA . Methods Female patients hospitalized for transabdominal hysterectomy were r and omly assigned to one of two pain management techniques : PCEA or preemptive epidural analgesia followed by PCEA ( PA + PCEA ) . Postoperative pain was assessed using the visual analog scale . Blood sample s were collected before , 24 , 48 , and 72 h following surgery . Production of the following cytokines was assessed ex vivo in stimulated peripheral blood mononuclear cells : interleukin (IL)-1&bgr ; , tumor necrosis factor & agr ; , IL-6 , IL-1ra , IL-10 , and IL-2 . Results Patients of the PA + PCEA group exhibited lower pain scores throughout the 72 h postoperatively , compared with patients of the PCEA group . In patients of the PA + PCEA group in the postoperative period , production of IL-1&bgr ; , IL-6 , IL-1ra , and IL-10 was significantly less elevated , while IL-2 production was significantly less suppressed . Conclusions Proinflammatory cytokines are key mediators of illness symptoms , including hyperalgesia . The present results suggest that preemptive epidural analgesia is associated with reduced postoperative pain and attenuated production of proinflammatory cytokines OBJECTIVE To explore the mechanism of electroacupuncture on rheumatoid arthritis ( RA ) . METHODS In a r and omized and controlled trial , sixty-three cases with RA were r and omly divided into an electroacupuncture group ( n = 32 ) and a simple acupuncture group ( n = 31 ) . Baihui ( GV 20 ) , Fengchi ( GB 20 ) , Quchi ( LI 11 ) , Waiguan ( TE 5 ) , Guanyuan ( CV 4 ) and Zusanli ( ST 36 ) were selected by coordination method combined whole and local acupoints . The electroacupuncture group was treated with electroacupuncture at the local acupoints near painful joints , continuous wave , retaining needle for 30 minutes , and then electroacupuncture at Back-shu acupoints , retaining needle for 15 minutes , and the simple acupuncture group was treated with the same acupoints selection and acupuncture manipulation without electroacupuncture apparatus . They were all treated once every other day for 20 days as one course . After 3 courses , changes of interleukins in peripheral blood and joint fluid of patients were observed . RESULTS Both of electroacupuncture and simple acupuncture had significant effect on IL-1 , IL-4 , IL-6 and IL-10 in peripheral blood and joint fluid of patients with RA ( P < 0.01 , P < 0.05 ) . But after electroacupuncture , the absolute value and improvement value of decreasing IL-1 in peripheral blood and joint fluid were super than those of simple acupuncture ( all P < 0.05 ) , and of IL-4 in joint fluid was super than that after simple acupuncture ( P < 0.05 ) , and of IL-6 and the absolute value of decreasing IL-10 were almost the same after both treatment ( all P > 0.05 ) , and after electroacupuncture , the improvement value of IL-10 in peripheral blood and joint fluid were super than those after simple acupuncture ( both P < 0.05 ) . CONCLUSION Electroacupuncture can effectively decrease the proinflammatory cytokine of IL-1 and IL-6 and increase the inhibition cytokine of IL-4 and IL-10 and improve the internal environment of occurrence and progression of RA This study examined the effect of transcutaneous electrical nerve stimulation applied over acupoints ( Acu-TENS ) on forced expiratory volume , in patients with asthma , after exercise . Thirty subjects were r and omly assigned to three groups . Group 1 received Acu-TENS over acupuncture points Lieque and Dingchuan for 45 min prior to a symptom-limited treadmill exercise test . Group 2 had Acu-TENS similarly applied prior to and throughout the exercise test . Group 3 mimicked Group 1 but without any electrical output from the device . Forced expiratory volume in one second ( FEV(1 ) ) and forced vital capacity ( FVC ) were recorded before , immediately after and at 20-min intervals post-exercise for 1h . Immediately after exercise , FEV(1 ) and FVC rose in Group 2 ( p=0.015 ) , but decreased in Group 1 and more so in Group 3 . The differences became even more marked at 20 , 40 and 60 min . Adjunctive Acu-TENS therapy appears to reduce decline of FEV(1 ) following exercise training in patients with asthma OBJECTIVES Transcutaneous electrical nerve stimulation ( TENS ) has been used to control post-thoracotomy pain with contrasting results . We aim ed to assess the efficacy of TENS on post-thoracotomy pain in relation of four criterion measurements as : ( i ) cytokines ; ( ii ) pain ; ( iii ) respiratory function and ( iv ) intake of narcotic medication . METHODS Between January 2008 and October 2010 , 58 patients
Output:
| It was observed through the meta- analysis synthesis measures that there were statistically significant differences following the use of TENS to reduce the general group of cytokines .
When grouped by chronic disease , by postoperative setting s , or by individual studies in the case of IL-6 , it was observed that the significant reduction of cytokines related to the use of TENS was maintained .
The use of TENS reduced the blood levels of proinflammatory cytokines ( we observed a protective factor of TENS in relation to inflammation ) . |
MS211440 | ***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 Although health-related quality of life ( HRQL ) is increasingly assessed in r and omized controlled trials ( RCTs ) , HRQL findings are not always incorporated into clinical decision making . We examined the current perspectives of oncologists on the use of HRQL findings from RCTs , and variation of these perspectives between countries and specialties . Methods A cross-sectional e-survey of oncologist members of the NCIC Clinical Trials Group , the United Kingdom National Cancer Research Institute Clinical Studies Groups , and the Australia/New Zeal and cancer clinical trials network was conducted . Respondents reported their perceptions of the usefulness of RCT HRQL outcomes for informing practice , their use of HRQL findings in practice , barriers/facilitators to this use , and preferences for HRQL data presentation in RCT publications . Chi-square tests compared responses between countries and specialties . Results A total of 396 oncologists participated ( estimated response rate : 30 % ) . The most frequently reported specialties were medical ( 46 % ) and radiation ( 37 % ) oncology . HRQL findings from RCTs were reported as useful ( 73 % ) , but were infrequently used to guide clinical decisions with patients . Perceived barriers were lack of time ( 67 % ) and underst and ing ( 57 % ) , and concerns about generalizability of results ( 68 % ) . Identified facilitators included joint publication of HRQL/ clinical outcomes ( 96 % ) and summary of clinical implication s of HRQL findings in RCT publications ( 76 % ) . Use of HRQL findings , perceived barriers/facilitators , and presentation preferences did not differ by country or specialty . Conclusions Oncologists support HRQL findings from RCTs , but perceive important barriers to their use in clinical decision making , regardless of country or specialty . Combined , clear reporting of HRQL/ clinical data may facilitate their clinical application Background : Limited data describe patient-reported outcomes ( PROs ) of localised oesophageal cancer treated with definitive chemoradiotherapy(CRT ) . The phase 2/3 SCOPE-1 trial assessed the effectiveness of CRT±cetuximab . The trial for the first time provided an opportunity to describe PROs from a multi-centre group of patients treated with CRT that are presented here . Methods : Patients undergoing CRT±cetuximab within the SCOPE-1 trial ( 258 patients from 36 UK centres ) completed generic- , disease- and treatment-specific health-related quality of life ( HRQL ) question naires ( EORTC QLQ-C30 , QLQ-OES18 , Dermatology Life- Quality Index ( DLQI ) ) at baseline and at 7 , 13 , 24 , 52 and 104 weeks . Mean EORTC functional scale scores ( > 15 point change significant ) , DLQI scores ( > 4 point change significant ) and proportions of patients ( > 15 % significant ) with ‘ minimal ’ or ‘ severe ’ symptoms are presented . Results : Question naire response rates were good . At baseline , EORTC functional scores were high ( > 75 % ) and few symptoms were reported except for severe problems with fatigue , insomnia and eating-related symptoms ( e.g. , appetite loss , dysphagia , dry mouth ) in both groups(>15 % ) . Functional aspects of health deteriorated and symptoms increased with treatment and by week 13 global quality of life , physical , role and social function significantly deteriorated and more problems with fatigue , dyspnoea , appetite loss and trouble with taste were reported . Recovery occurred by 6 months ( except severe fatigue and insomnia in > 15 % of patients ) and maintained at follow-up with no differences between groups . Conclusions : CRT for localised oesophageal cancer has a significant detrimental impact on many aspects of HRQL ; however , recovery is achieved by 6 months and maintained with the exception of persisting problems with severe fatigue and insomnia . The data suggest that the HRQL recovery after definitive CRT is quicker , and there is little lasting deficit compared with treatment including surgery . These data need to be compared with HRQL data from studies evaluating treatments including surgery for oesophageal cancer Results for health-related quality of life ( HRQoL ) from clinical trials are increasingly used for clinical decision making as well as comparative eff ectiveness , health policy , and reimbursement decisions . Research suggests that HRQoL information can be used to establish treatment preferences because patients value HRQoL data and can interpret HRQoL fi ndings accurately . Trials that incorporate HRQoL as an outcome should therefore be design ed , analysed , and reported well . We did a systematic review of the literature and identifi ed 18 publications with guidelines or st and ards for reporting of HRQoL in r and omised controlled trials , which draw attention to the need for good quality in both trial design and reporting . With regard to trial design , examples of key quality criteria include : the need to use reliable and valid HRQoL measures that are appropriate for the population of interest and that include core outcomes agreed by clinicians , research ers , and patients ; timing of HRQoL assessment that is relevant to clinical interpretation of results ; minimisation of missing data ( since data are often not missing r and omly , but instead could be linked to other clinical outcomes of interest , with those most unwell not providing data ) ; and use of prespecifi ed statistical analyses to avoid multiple statistical testing and selective reporting of results . Given these and other requirements for quality st and ards in clinical trial design , many authors have recommended st and ards for HRQoL reporting so that readers of trial reports can ascertain whether quality st and ards have been reached . Such st and ard criteria have included , for example , the provision of a clear rationale for the domains of HRQoL assessment ( eg , specifi c symptoms such as pain , or functions such as activity levels ) and the corresponding choice of HRQoL instrument , with cited evidence of the instrument ’s validity and a statement about the timing of HRQoL assessment s used in the trial . Trials should report baseline compliance and the extent of subsequent missing data , since reports that omit details about the amount of missing data , or report substantial missing data , should be interpreted with caution . Type 1 statistical errors , result ing from multiple statistical testing , can be addressed by the requirement that trial protocol s prespecify the principal HRQoL postulated outcomes , and their respective timepoints for analysis and reporting in the fi nal trial publication . Finally , reporting of HRQoL data in a comprehensible , clinical ly applicable format , and in the context of other trial outcomes might better promote the use of HRQoL data in practice . Despite these existing recommendations , a systematic review of 794 r and omised trials undertaken between 2002 and 2008 that reported HRQoL outcomes across a range of medical conditions showed that only 56 % of trials provided a rationale for the selected outcome measure , 50 % provided an HRQoL hypothesis , 28 % provided information about missing data , and 36 % did not discuss the HRQoL fi ndings in the context of the other trial outcomes . The review noted that when HRQoL data 8 Ezzati M , Kammen DM . Indoor air pollution from biomass combustion and acute respiratory infections in Kenya : an exposure-response study . Lancet 2001 ; 358 : 619–24 . 9 Naeher LP , Smith KR , Leaderer BP , Mage D , Grajeda R. Indoor and outdoor PM2.5 and CO in high and low-density Guatemalan villages . J Expo Anal Environ Epidemiol 2000 ; 10 : 544–51 . 10 Barraza-Villarreal A , Sunyer J , Hern and ez-Cadena L , et al. Air pollution , airway infl ammation , and lung function in a cohort study of Mexico City schoolchildren . Environ Health Perspect 2008 ; 116 : 832–38 . 11 Moshammer H , Hoek G , Luttmann-Gibson H , et al. Parental smoking and lung function in children : an international study . Am J Respir Crit Care Med 2006 ; 173 : 1255–63 . 12 Miller RL , Daswani M , Lendor C. Prenatal exposure to air pollution and respiratory outcomes in children . In : Jeorgenson NA , ed . Passive smoking and health research . New York : Nova Science Publishers , 2007 : 283–96 BACKGROUND Patient reported outcomes ( PROs ) have gained a prominent place in clinical research . Previous estimates suggest that PRO measures are used in 14 % of clinical trials . Online registries , such as Clinical Trials.gov , may be useful in evaluating extent of PRO use . PURPOSE To estimate the proportion of clinical trials using at least one PRO measure and to examine associations between trial characteristics and use of PRO measures . METHODS A copy of the Clinical Trials.gov data base was made , containing all data from November 2007 to December 2013 . Content was search ed for use of PRO measures . Multivariable logistic regression was used to investigate possible associations between trial-level characteristics and use of PRO measures . RESULTS Of 96,736 registered trials , 26,337 ( 27 % ) were identified as using one or more PRO measures . Among oncology trials , 29 % ( 3947/13,584 ) were identified as using a PRO measure , compared to 27 % ( 22,390/83,152 ) of non-oncology trials . A greater proportion of trials using PRO measures were more likely to be sponsored by university/ research organizations ( 29 % ) or the US government ( 33 % ) , compared to industry ( 22 % ) ; Phase III ( 35 % ) ; non-r and omized ( 32 % ) ; and evaluating devices ( 30 % ) , procedures ( 31 % ) or behaviors ( 50 % ) , compared to drugs ( 24 % ) . Fewer were FDA -regulated ( 23 % ) . CONCLUSIONS Evidence suggests that between 2007 and 2013 , there has been an increase in the number of trials that use a PRO measure , particularly in oncology trials . With initiatives such as the Patient-Focused Drug Development and FDA PRO Guidance , the trend in the use of PRO measures in clinical research will likely increase further Abstract Background Patient-reported outcomes ( PROs ) are captured within cancer trials to help future patients and their clinicians make more informed treatment decisions . However , variability in st and ards of PRO trial design and reporting threaten the validity of these endpoints for application in clinical practice . Methods We systematic ally investigated a cohort of r and omized controlled cancer trials that included a primary or secondary PRO . For each trial , an evaluation of protocol and reporting quality was undertaken using st and ard checklists . General patterns of reporting where also explored . Results Protocol s ( 101 source d , 44.3 % ) included a mean ( SD ) of 10 ( 4 ) of 33 ( range = 2–19 ) PRO protocol checklist items . Recommended items frequently omitted included the rationale and objectives underpinning PRO collection and approaches to minimize/address missing PRO data . Of 160 trials with published results , 61 ( 38.1 % , 95 % confidence interval = 30.6 % to 45.7 % ) failed to include their PRO findings in any publication ( mean 6.43-year follow-up ) ; these trials included 49 568 participants . Although two-thirds of included trials published PRO findings , reporting st and ards were often inadequate according to international guidelines ( mean [ SD ] inclusion of 3 [ 3 ] of 14 [ range = 0–11 ] ) CONSORT PRO Extension checklist items ) . More than one-half of trials publishing PRO results in a secondary publication ( 12 of 22 , 54.5 % ) took 4 or more years to do so following trial closure , with eight ( 36.4 % ) taking 5–8 years and one trial publishing after 14 years . Conclusions PRO protocol content is frequently inadequate , and nonreporting of PRO findings is widespread , meaning patient-important information may not be available to benefit patients , clinicians , and regulators . Even where PRO data are published , there is often considerable delay and reporting quality is suboptimal . This study presents key recommendations to enhance the likelihood of successful delivery of PROs in the future
Output:
| The included publications identified several barriers and facilitators around PRO trial design , conduct , analysis and report that can hinder or promote the impact of PRO trial data .
Conclusions PRO trial data may potentially lead to a range of benefits for patients and society , which can be measured through appropriate impact metrics .
However , in practice there is relatively limited evidence demonstrating directly attributable and indirect real world PRO-related research impact . |
MS211441 | ***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 Smoking cessation interventions are needed for young adults . Innovative approaches to behavior change for this population should be tested . Formative research and process evaluation of those approaches would result in more effective programs . This paper presents the development process and process evaluation of a web-based smoking cessation program . A description of the stages of development is presented with formative research , development of the web-based intervention , formative evaluation , and process evaluation . The smokers reported high usage of the intervention and satisfaction with the intervention in that it helped to raise their consciousness about quitting , encouraged them to set behavioral goals , provided stages of change feedback , and offered interactivity in presenting information and strategies about quitting . The Internet may be a promising tool for patient education according to the process results Objective : Alcohol consumption has been a growing concern at U.S. colleges , particularly among first-year students , who are at increased risk for problems . This study tested the efficacy of the “ electronic Check-Up to Go ” ( e-CHUG ) , a commercially-available internet program , at reducing drinking among a group of at-risk college freshman . Method : The design was a r and omized controlled trial : 106 freshmen students who reported heavy episodic drinking were r and omly assigned to receive feedback or to assessment only . Assessment measures were completed at baseline , 8 weeks , and 16 weeks . Results : At 8 weeks , the feedback group showed a significant decrease in drinks per week and peak BAC over control . By 16 weeks , the control group also declined to a point where there were no differences between groups . Changes in normative drinking estimates mediated the effect of the intervention . An additional 245 abstainers and light drinkers who were also r and omized to condition did not show any intervention effect . Conclusions : This study provides preliminary support for the efficacy of this intervention at reducing short-term drinking among at-risk students AIMS To test the feasibility of online alcohol screening and brief intervention ( BI ) by comparing ( i ) two approaches to inviting all students to be screened , and ( ii ) a minimal versus a more extensive BI . METHODS Freshmen students at one university were r and omized to receive one of two types of email invitations to an online anonymous : ( i ) general health assessment , or ( ii ) alcohol-specific assessment . All were linked to the same alcohol screening survey . Those with unhealthy alcohol use ( AUDIT > or=8 ) were r and omly assigned to minimal or more extensive online alcohol BI . RESULTS In both invitation groups ( 4008 students ) , 55 % of students completed the online screening . Overall , 37 % of men and 26 % of women had unhealthy alcohol use . Compared to minimal BI , more extensive BI was associated with intention to seek help among men and with a greater increase in readiness to change among women . One month after BI , 75 % of students completed another assessment , 33 % of women and 15 % of men with unhealthy alcohol use at baseline no longer had unhealthy alcohol use . There were no significant differences on drinking measures by BI r and omization group . CONCLUSIONS Over half of an entire freshman class of college students were reached by email and completed alcohol screening and brief intervention . Even an alcohol-specific invitation did not deter students . Although brief interventions that differed had some gender specific effects on readiness to change and intention , in general , unhealthy alcohol use decreased after brief intervention . Web screening and brief intervention show promise for addressing unhealthy alcohol use by college students OBJECTIVES This study aim ed to develop an Internet-assisted smoking cessation program accompanied with auricular acupressure , and compare the quit rate and self-efficacy of youth smokers receiving auricular acupressure with and without the Internet-assisted smoking cessation program . DESIGN A Website was constructed on IBM Websphere 5.0 and DB2 data base using HTML , Javascript , and JSP . A quasiexperimental research design was adopted . Subjects were assigned nonr and omly to two groups . Group 1 received auricular acupressure plus the Internet-assisted smoking cessation program , whereas group 2 received auricular acupressure only . MEASUREMENTS The data of demographic factors , serum cotinine , quitting rate , nicotine dependence , and self-efficacy of subjects were collected before and after a 4-week intervention . RESULTS After intervention , the quit rate was 15.78 % in group 1 and 2.56 % in group 2 . Nicotine dependence was significantly lowered in group 1 , but remained unchanged in group 2 . The improvement of self-efficacy between groups 1 and 2 was significantly different . CONCLUSIONS The combination of auricular acupressure and Internet-assisted smoking cessation program was more efficacious than auricular acupressure alone in terms of quit rate PURPOSE The Internet offers a potential medium for delivering smoking cessation treatment to adolescents . However , few Internet-based cessation programs for adolescents have been evaluated . We describe adolescent use of a home-based Internet intervention to stop smoking ( Stomp Out Smokes [ SOS ] ) and explore baseline characteristics associated with SOS use . METHODS Participants were 70 adolescent smokers aged 12 - 18 years ( 50 % female , 90 % Caucasian ) r and omized to receive the SOS intervention for 24 weeks as part of a larger clinical trial . SOS comprised 40 components , of which eight were primarily interactive ( e.g. , discussion support group , ask an expert , quit plan ) and 32 were primarily informational ( e.g. , managing withdrawal , medications to stop smoking ) . SOS use data were captured electronically , including total logins to the site , and type of SOS components used defined by page hits on the interactive and information components . RESULTS A total of 7,708 SOS website pages ( 6825 interactive and 883 informational ) were accessed over the 24 weeks . The highest proportion of page hits was for the discussion support group ( 35 % ) and quit plan ( 30 % ) . Interactive pages were significantly more likely to be used than informational pages ( median 65 vs. 6 , p < .001 ) . Males accessed fewer interactive pages compared with females ( p = .04 ) . No other baseline characteristics were univariately associated with total logins or use of informational or interactive pages . CONCLUSIONS Adolescent smokers most often used a discussion support group and other interactive Internet-based cessation components . Future studies design ed to increase adolescent use , and efficacy of , Internet-based cessation programs are warranted The authors investigated the efficacy of an interactive Web site , MyStudentBody.com : Alcohol ( MSB : Alcohol ) that offers a brief , tailored intervention to help heavy drinking college students reduce their alcohol use . They conducted a r and omized , controlled clinical trial to compare the intervention with an alcohol education Web site at baseline , postintervention , and 3-month follow-up . Students were assessed on various drinking measures and their readiness to change their drinking habits . The intervention was especially effective for women and persistent binge drinkers . Compared with women who used the control Web site , women who used the intervention significantly reduced their peak and total consumption during special occasions and also reported significantly fewer negative consequences related to drinking . In addition , persistent heavy binge drinkers in the experimental group experienced a more rapid decrease in average consumption and peak consumption compared with those in the control group . The authors judged MSB : Alcohol a useful intervention for reaching important subgroups of college binge drinkers OBJECTIVE A r and omized controlled trial tested the efficacy of an internet-based lifestyle behavior modification program for African-American girls over a 2-year period of intervention . RESEARCH METHODS AND PROCEDURES Fifty-seven overweight ( mean BMI percentile , 98.3 ) African-American girls ( mean age , 13.2 years ) were r and omly assigned to an interactive behavioral internet program or an internet health education program , the control condition . Overweight parents were also participants in the study . Forty adolescent-parent dyads ( 70 % ) completed the 2-year trial . Outcome data including BMI , body weight , body composition , and weight loss behaviors were collected at baseline and at 6-month intervals . A computer server tracked use of the web sites . RESULTS An intention-to-treat statistical approach was used , with the last observation carried forward . In comparison with the control condition , adolescents in the behavioral program lost more mean body fat ( BF ) ( -1.12 + /- 0.47 % vs. 0.43 + /- 0.47 % BF , p < 0.05 ) , and parents in the behavioral program lost significantly more mean body weight ( -2.43 + /- 0.66 vs. -0.35 + /- 0.64 kg , p < 0.05 ) during the first 6 months . This weight loss was regained over the next 18 months . After 2 years , differences in fat for adolescents ( -0.08 + /- 0.71 % vs. 0.84 + /- 0.72 % BF ) and weight for parents ( -1.1 + /- 0.91 vs. -0.60 + /- 0.89 kg ) did not differ between the behavioral and control programs . DISCUSSION An internet-based weight management program for African-American adolescent girls and their parents result ed in weight loss during the first 6 months but did not yield long-term loss due to reduced use of the web site over time The goal of this longitudinal study was to test an innovative approach to smoking cessation that might be particularly attractive to adolescent smokers . The study was a participatory research effort between academic and school partners . The intervention used an Internet-based , virtual reality world combined with motivational interviewing conducted in real-time by a smoking cessation counselor . Participants were 136 adolescent smokers recruited from high schools r and omized to the intervention or a measurement-only control condition . Those who participated in the program were significantly more likely than controls to report at the immediate post-intervention assessment that they had abstained from smoking during the past week ( p < or=.01 ) , smoked fewer days in the past week ( p < or=.001 ) , smoked fewer cigarettes in the past week ( p < or=.01 ) , and considered themselves a former smoke ( p < or=.05 ) . Only the number of times quit was statistically significant at a one-year follow-up assessment ( p < or=.05 ) . The lack of longer-term results is discussed , as are method ological challenges in conducting a cluster-r and omized smoking cessation study Background Published research on the use of Web-based behavior change programs is growing rapidly . One of the observations characterized as problematic in these studies is that participants often make relatively few website visits and spend only a brief time accessing the program . Properly structured websites permit the unobtrusive measurement of the ways in which participants access ( are exposed to ) program content . Research on participant exposure to Web-based programs is not merely of interest to technologists , but represents an important opportunity to better underst and the broader theme of program engagement and to guide the development of more effective interventions . Objectives The current paper seeks to provide working definitions and describe initial patterns of various measures of participant exposure to ChewFree.com , a large r and omized controlled trial of a Web-based program for smokeless tobacco cessation . Methods We examined measures of participant exposure to either an Enhanced condition Web-based program ( interactive , tailored , and rich-media program ) or a Basic condition control website ( static , text-based material ) . Specific measures focused on email prompting , participant visits ( number , duration , and pattern of use over time ) , and Web page viewing ( number of views , types of pages viewed , and Web forum postings ) . Results Participants in the ChewFree.com Enhanced condition made more visits and spent more time accessing their assigned website than did participants assigned to the Basic condition website . In addition , exposure data demonstrated that Basic condition users thoroughly accessed program content , indicating that the condition provided a meaningful , face-valid control to the Enhanced condition . Conclusions We recommend that research ers conducting evaluations of Web-based interventions consider the collection and analysis of exposure measures in the broader context of program engagement in order to assess whether participants obtain sufficient exposure to relevant program content Pilot studies revealed promising results regarding crushing virtual cigarettes to reduce tobacco addiction . In this study , 91 regular smokers were r and omly assigned to two treatment conditions that differ only by the action performed in the virtual environment : crushing virtual cigarettes or grasping virtual balls . All participants also received minimal psychosocial support from nurses during each of 12 visits to the clinic . An affordable virtual reality system was used ( eMagin H
Output:
| Patterns of effective strategies could be observed , such as the combination of tailored communication and the use of reminders and incentives . |
MS211442 | ***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 Normal brain and visual development is thought to require exogenous docosahexaenoic acid ( DHA ; 22:6n-3 ) intake , but the amount needed is debatable . Because the supplementation of breastfeeding mothers with DHA increases the DHA content of their infants ' plasma lipids , we hypothesized that it might also improve brain or visual function in the infants . OBJECTIVE The objective was to determine the effect of DHA supplementation of breastfeeding mothers on neurodevelopmental status and visual function in the recipient infant . DESIGN Breastfeeding women received capsules containing either a high-DHA algal oil ( approximately 200 mg DHA/d ) or a vegetable oil ( no DHA ) for 4 mo after delivery . Outcome variables included the fatty acid pattern of maternal plasma phospholipid and milk lipids 4 mo postpartum , the fatty acid pattern of plasma phospholipids and visual function in infants at 4 and 8 mo of age , and neurodevelopmental indexes of the infants at 12 and 30 mo of age . RESULTS Milk lipid and infant plasma phospholipid DHA contents of the supplemented and control groups were approximately 75 % and approximately 35 % higher , respectively , at 4 mo postpartum . However , neither the neurodevelopmental indexes of the infants at 12 mo of age nor the visual function at 4 or 8 mo of age differed significantly between groups . In contrast , the Bayley Psychomotor Development Index , but not the Mental Development Index , of the supplemented group was higher ( P < 0.01 ) at 30 mo of age . CONCLUSION DHA supplementation of breastfeeding mothers results in higher infant plasma phospholipid DHA contents during supplementation and a higher Bayley Psychomotor Development Index at 30 mo of age but results in no other advantages either at or before this age Abstract n−3 PUFA influence immune functioning and may affect the cytokine phenotype during development . To examine whether maternal fish oil supplementation during lactation could modify later immune responses in children , 122 lactating Danish mothers with a fish intake below the population median were r and omized to groups supplemented for the first 4 mon of lactation with 4.5 g/d of fish oil ( equivalent to 1.5 g/d of n−3 long-chain PUFA ) or olive oil . Fifty-three mothers with a fish intake in the highest quartile of the population were also included . The FA composition of erythrocyte membranes was measured at 4 mon and at 2 1/2 yr . Plasma immunoglobulin E ( IgE ) levels and cytokine production in lipopolysaccharide-stimulated whole-blood cultures were determined at 2 1/2 yr . Erythrocyte n−3 PUFA at 4 mon were higher in infants from the fish oil group compared with the olive oil group ( P<0.001 ) but were no longer different at 2 1/2 yr . The median production of lipopolysaccharide-induced interferon γ(IFN-γ ) in the fish oil group was fourfold higher than that in the olive oil group ( P=0.034 ) , whereas interleukin-10 ( IL-10 ) production was similar . The IFN-γ/IL-10 ratio was twofold higher in the fish oil group ( P=0.019 ) and was positively correlated with 20∶5n−3/20∶4n−6 in erythrocytes at 4 mon ( P=0.050 ) . The percentages of atopic children and plasma IgE were not different in the two groups , but the study was not design ed to look at atopy . Cytokine responses and erythrocyte FA composition in children of mothers with a high fish intake were intermediate in comparison with those in the r and omized groups . Fish oil supplementation during lactation result ed in increased in vitro IFN-γ production in the children 2 yr after the supplementation was given , which may reflect a faster maturation of the immune system OBJECTIVE This study was design ed to assess the relation of exclusive breast-feeding , independent of recognized risk factors , to acute and recurrent otitis media in the first 12 months of life . METHODS Records of 1220 infants who used a health maintenance organization and who were followed during their first year of life as part of the Tucson Children 's Respiratory Study were review ed . Detailed prospect i ve information about the duration and exclusiveness of breast-feeding was obtained , as was information relative to potential risk factors ( socioeconomic status , gender , number of siblings , use of day care , maternal smoking , and family history of allergy ) . Acute otitis media and recurrent otitis media , defined as three or more episodes of acute otitis media in a 6-month period or four episodes in 12 months , were the outcome variables . RESULTS Of the 1013 infants followed for their entire first year , 476 ( 47 % ) had at least one episode of otitis and 169 ( 17 % ) had recurrent otitis media . Infants exclusively breast-fed for 4 or more months had half the mean number of acute otitis media episodes as did those not breastfed at all and 40 % less than those infants whose diets were supplemented with other foods prior to 4 months . The recurrent otitis media rate in infants exclusively breast-fed for 6 months or more was 10 % and was 20.5 % in those infants who breast-fed for less than 4 months . This protection was independent of the risk factors considered . CONCLUSION These findings suggest that exclusive breast-feeding of 4 or more months protected infants from single and recurrent episodes of otitis media Study objective : To investigate the association of having been breast fed with cardiovascular disease risk factors , incidence , and mortality . Design : Prospect i ve cohort study . Setting : Caerphilly , South Wales . Participants : All men aged 45–59 years living in and around the study area . Of 2818 eligible men , 2512 ( 89 % ) were seen . Altogether 1580 men ( 63 % ) obtained details of how they had been fed in infancy ( ever breast fed or only bottle fed ) from their mother or a close female relative . A subset of 1062 subjects reported on whether bottle fed or the duration of breast feeding if breast fed . Main results : Breast feeding was not associated with stature , blood pressure , insulin resistance , total cholesterol , or fibrinogen . In fully adjusted models ( controlling for age , birth order , and social position in childhood and adulthood ) , breast feeding was associated with greater body mass index than bottle feeding ( difference : 0.41 kg/m2 ( 95 % CI : 0.01 to 0.81 ) . There was a positive association between breast feeding and coronary heart disease mortality ( hazard ratio : 1.73 ; 1.17 to 2.55 ) and incidence ( 1.54 ; 1.17 to 2.04 ) ( fully adjusted models ) . There was no evidence of a duration -response effect , which might be expected if an adverse effect of breast feeding was causal . Conclusion : These data provide little evidence of a protective influence of breast feeding on cardiovascular disease risk factors , incidence , or mortality . A possible adverse effect of breast feeding on coronary heart disease incidence was observed but may have a number of explanations , including selection and information bias . In view of these limitations , further long term studies with improved measures of infant feeding are required to confirm or refute these findings Abstract Objective : To investigate the relation of infant feeding practice to childhood respiratory illness , growth , body composition , and blood pressure . Design : Follow up study of a cohort of children ( mean age 7.3 years ) who had detailed infant feeding and demographic data collected prospect ively during the first two years of life . Setting : Dundee . Subjects : 674 infants , of whom 545 ( 81 % ) were available for study . Data on respiratory illness were available for 545 children ( mean age 7.3 ( range 6.1- 9.9 ) years ) ; height for 410 children ; weight and body mass index for 412 children ; body composition for 405 children ; blood pressure for 301 children ( mean age 7.2 ( range 6.9 - 10.0 ) years ) . Main outcome measures : Respiratory illness , weight , height , body mass index , percentage body fat , and blood pressure in relation to duration of breast feeding and timing of introduction of solids . Results : After adjustment for the significant confounding variables the estimated probability of ever having respiratory illness in children who received breast milk exclusively for at least 15 weeks was consistently lower ( 17.0 % ( 95 % confidence interval 15.9 % to 18.1 % ) for exclusive breast feeding , 31.0 % ( 26.8 % to 35.2 % ) for partial breast feeding , and 32.2 % ( 30.7 % to 33.7 % ) for bottle feeding . Solid feeding before 15 weeks was associated with an increased probability of wheeze during childhood ( 21.0 % ( 19.9 % to 22.1 % ) v 9.7 % ( 8.6 % to 10.8 % ) ) . It was also associated with increased percentage body fat and weight in childhood ( mean body fat 18.5 % ( 18.2 % to 18.8 % ) v 16.5 % ( 16.0 % to 17.0 % ) ; weight st and ard deviation score 0.02 ( −0.02 to 0.06 ) v −0.09 ( −0.16 to 0.02 ) . Systolic blood pressure was raised significantly in children who were exclusively bottle fed compared with children who received breast milk ( mean 94.2 ( 93.5 to 94.9 ) mm Hg v 90.7 ( 89.9 to 91.7 ) mm Hg ) . Conclusions : The probability of respiratory illness occurring at any time during childhood is significantly reduced if the child is fed exclusively breast milk for 15 weeks and no solid foods are introduced during this time . Breast feeding and the late introduction of solids may have a beneficial effect on childhood health and subsequent adult disease . Key messages Current guidelines in the United Kingdom recommend that babies are exclusively breast fed for the first 4 months of life , with solids being introduced thereafter This study found that exclusive breast feeding is associated with a significant reduction in childhood respiratory illness The early introduction of solids is associated with increased body fat and weight in childhood Exclusive bottle feeding is associated with higher systolic blood pressure in childhood Breast feeding and delaying the introduction of solids until after 15 weeks may have a beneficial effect on childhood health and subsequent adult The neuropeptide oxytocin is essential for mammalian parturition and lactation . Recent animal studies suggest that oxytocin is also implicated in the central nervous control of behavior including learning and memory . There has been little investigation , however , of the impact of oxytocin on human memory . The purpose of this study was to investigate the effect of a single dose of intranasal oxytocin on implicit and explicit memory in humans . In a placebo-controlled , double-blind study , 38 healthy men were r and omly assigned to receive intranasal oxytocin ( 24 IU ) or placebo 50 min before the study phase ( incidental learning ) . Memory was measured using three different memory tests : an implicit perceptual test ( word stem completion ) , an implicit conceptual test ( category-cued semantic association ) , and an explicit test ( cued recall ) . Due to the reproductive-biological role of oxytocin and the impact of adequate environmental conditions for the stimulation of behavioral effects of oxytocin known from animal research , we used semantic word stimuli with reproduction-related vs. neutral meaning . Oxytocin significantly impaired recall performance as compared with placebo treatment irrespective of the meaning of words in the cued recall test . In the implicit conceptual test , characterized by a deepened information processing , compared with placebo , oxytocin significantly impaired only the overall generation of associated target words with reproduction relevant meaning , whereas no significant difference between oxytocin and placebo was obtained for neutral words . These findings concur with data from animal research suggesting that central oxytocin selectively influences memory performance depending on the kind of memory test used and , more importantly , the psychobiological relevance of stimuli CONTEXT A number of studies suggest a positive association between breastfeeding and cognitive development in early and middle childhood . However , the only previous study that investigated the relationship between breastfeeding and intelligence in adults had several method ological shortcomings . OBJECTIVE To determine the association between duration of infant breastfeeding and intelligence in young adulthood . DESIGN , SETTING , AND PARTICIPANTS Prospect i ve longitudinal birth cohort study conducted in a sample of 973 men and women and a sample of 2280 men , all of whom were born in Copenhagen , Denmark , between October 1959 and December 1961 . The sample s were divided into 5 categories based on duration of breastfeeding , as assessed by physician interview with mothers at a 1-year examination . MAIN OUTCOME MEASURES Intelligence , assessed using the Wechsler Adult Intelligence Scale ( WAIS ) at a mean age of 27.2 years in the mixed-sex sample and the Børge Priens Prøve ( BPP ) test at a mean age of 18.7 years in the all-male sample . Thirteen potential confounders were included as covariates : parental social status and education ; single mother status ; mother 's height , age , and weight gain during pregnancy and cigarette consumption during the third trimester ; number of pregnancies ; estimated gestational age ; birth weight ; birth length ; and indexes of pregnancy and delivery complications . RESULTS Duration of breastfeeding was associated with significantly higher scores on the Verbal , Performance , and Full Scale WAIS IQs . With regression
Output:
| There is also some evidence of lower prevalence of inflammatory bowel diseases , childhood cancers , and type I diabetes in breast-fed infants , suggesting that breast-feeding influences the development of the infant 's own immune system .
One of the most consistent findings of breast-feeding is a positive effect on later intelligence tests with a few test points advantage for breast-fed infants .
There seems to be a small protective effect against later overweight and obesity .
Blood pressure and blood cholesterol seem to be slightly lower in breast-fed infants ; however , the few studies examining breast-feeding and the risk of coronary heart disease in later life did not find an association . |
MS211443 | ***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: INTRODUCTION Pharmacotherapy for upper gastrointestinal bleeding has been difficult to evaluate because clinical end points are infrequent and affected by other factors . AIMS To evaluate whether blood in the stomach at endoscopy reflected severity of bleeding , predicted clinical outcomes , and could be altered by therapeutic agents . METHODS We studied 414 consecutive admissions with suspected upper gastrointestinal bleeding . Patients were r and omised to receive lansoprazole 60 mg followed by 30 mg four times daily , tranexamic acid 2 g followed by 1 g four times daily , both drugs , or placebo for four days , until discharge or a clinical end point occurred . Logistic regression analysis was used to determine predictors of endoscopic changes and clinical outcomes , and to investigate the effects of drug treatments on blood in the stomach . RESULTS Of 414 patients with suspected upper gastrointestinal bleeding , 379 were endoscoped . Upper gastrointestinal bleeding was confirmed in 316 . Sixteen required surgery within 30 days and 16 died on the index admission . Trial treatments were evaluable on a per protocol basis in 228 patients . The amount of blood in the stomach was found to reflect initial risk , with significant associations with high risk categorisation ( odds ratio 3.7 ( 95 % confidence interval 1.5–9.4 ) for more than a trace v none/trace ) , age ( 1.5 ( 1.1–1.9 ) per decade ) , and initial pulse ( 1.02 ( 1.00–1.04 ) per beat ) , and to predict rebleeding ( 9.2 ( 4.6–18.7 ) ) and surgery ( 8.2 ( 2.9–22.9 ) ) . Other stigmata were less significant in these respects . The amount of blood in the stomach at endoscopy was reduced significantly by both lansoprazole ( 0.22 ( 0.07–0.63 ) ) and tranexamic acid ( 0.27 ( 0.09–0.81 ) ) , although there was no evidence of synergy . CONCLUSIONS Blood in the stomach reflects clinical features in patients with acute upper gastrointestinal bleeding and is reduced by treatment with lansoprazole and tranexamic acid The efficacy of antifibrinolytic therapy in the management of acute upper gastrointestinal haemorrhage has been investigated in a double-blind clinical trial . Two-hundred patients were studied using tranexamic acid , a potent antifibrinolytic agent . Of these , 103 were in the treatment group and 97 in the control group . Patients were analysed to determine severity of initial blood loss , transfusion requirements , together with the incidence of recurrent bleeding , surgical intervention , and death . Final diagnosis as to the site of bleeding was arrived at using endoscopy , barium studies , and the findings at operation and necropsy . The groups were well matched as regards severity of initial haemorrhage , age , sex , aetiological diagnosis , and precipitating factors . A significant difference was observed in the requirement for surgical intervention to control continuing or recurrent haemorrhage . Twenty-three of 97 in the control group and seven of 103 in the treatment group required surgery . There appeared to be a reduction in the transfusion rate after the first three days of hospitalization in the treatment group . There were no significant differences in mortality or in side-effects between the two groups We studied the effects of tranexamic acid ( an antifibrinolytic agent ) and cimetidine on acute upper-gastrointestinal-tract bleeding in a double-blind r and omized placebo-controlled trial in 775 patients with hematemesis or melena or both . Mortality was significantly reduced in patients receiving either tranexamic acid ( mortality , 6.3 per cent ) or cimetidine ( 7.7 per cent ) , as compared with patients receiving placebo ( 13.5 per cent ) ( P = 0.0092 for tranexamic acid vs. placebo , P = 0.045 for cimetidine vs. placebo ) . Ninety-nine patients were withdrawn before the code was broken , mainly because their primary illness was considered not to be due to acute upper-gastrointestinal-tract bleeding . Mortality among those withdrawn was high ( 22 per cent ) , and their exclusion reduced death rates to 4 per cent in those given tranexamic acid , 8 per cent in those given cimetidine , and 11 per cent in those given placebo ( P = 0.0072 for tranexamic acid vs. placebo , P greater than 0.50 for cimetidine vs. placebo ) . The reduced mortality associated with tranexamic acid was detectable at both participating hospitals and in most of the main subgroups of patients classified according to site of bleeding . However , treatment with this agent was not associated with any decrease in the rate of rebleeding or the need for operation A prospect i ve r and omised double blind study examined the effect of the antifibrinolytic drug tranexamic acid compared with placebo in 154 patients bleeding from verified benign lesions in the stomach or duodenum or both . Three out of 72 patients receiving tranexamic acid underwent emergency surgery compared with 15 out of 82 given placebo ( p = 0.010 ) . Nineteen patients receiving placebo rebled during their admission as compared with 10 in the active treatment group ( p = 0.097 ) . Blood transfusion requirements were significantly reduced by tranexamic acid ( p = 0.018 ) . Side effects occurred in six patients , of which an uncomplicated deep venous thrombosis was the most severe . Tranexamic acid reduces the blood transfusion requirement and need for emergency surgery in patients bleeding from a benign gastric or duodenal lesion The effect or oral tranexamic acid on massive upper gastrointestinal hemorrhage was evaluated in a r and omized double-blind study . Totally 50 patients entered the trial and seven were excluded , leaving 22 placebo treated and 21 tranexamic acid treated for analysis . The groups were comparable regarding sex , age , diagnosis , and initial laboratory data . Transfusions requirements and operation frequency did not differ . Mortality was slightly reduced and death delayed in tranexamic acid treated patients Abstract In a double-blind trial in patients with bleeding from the upper gastrointestinal tract , those whose source of bleeding was distal to the gastro-œsophageal junction and whose barium-meal examination was negative benefited from oral tranexamic acid ( ' Cyclokapron ' ) ( 1·5 g. , eight-hourly ) . The volume of blood required for retransfusion was less in the treated group , especially in those patients with a negative barium-meal examination . These findings are compatible with the concept of a fibrinolytic component in upper gastrointestinal bleeding , which may be of particular importance when bleeding is due to acute superficial erosions In a double-blind trial of tranexamic acid in massive upper gastrointestinal haemorrhage , 76 patients were treated with the active drug and 73 patients with placebo . The doses were 1 g intravenously six times daily for a maximum of 3 days , followed by 1.5 g orally four times daily for a maximum of 4 days . The treatment group and the placebo group were comparable with respect to mean age , diagnoses and laboratory tests but differed slightly with respect to sex and alcohol consumption . The transfusion requirement in the treatment group was less than in the placebo group during the first days after admission , the difference being significant on the second day after admission . Ten patients in the treatment group and 18 patients in the placebo group were operated on . Eleven patients in the treatment group and 12 patients in the placebo group died . In the tranexamic-acid-treated group fewer operations were performed and significantly less blood was needed . It therefore seems highly likely that tranexamic acid has a beneficial effect , although small
Output:
| The clinical bottom line is that there is insufficient evidence , at the moment , to recommend the use of tranexamic acid in the management of upper gastrointestinal bleeding |
MS211444 | ***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 adherence to screening for hepatocellular carcinoma ( HCC ) is not well known . Our aims were to analyze the adherence to a surveillance program in a prospect i ve cohort of cirrhotic patients and to examine its association with HCC stage at diagnosis . Material s and Methods : A total of 770 patients with cirrhosis were examined semiannually by ultrasound and alpha-fetoprotein at a tertiary center . We collected data on 17 variables at baseline . Suboptimal adherence was defined as failure to complete 2 consecutive screening rounds . Results : Over a median follow-up period of 42.0 months ( interquartile range : 60.0 ) , 125 patients ( 16.2 % ) had suboptimal adherence . Active or previous intravenous drug use [ hazard ratio ( HR ) , 5.33 ; 95 % confidence interval ( CI ) , 3.07 - 9.23 ] , active alcohol consumption ( HR , 3.03 ; 95 % CI , 2.03 - 4.51 ) , absence of liver decompensation before the inclusion in the program ( HR , 1.65 ; 95 % CI , 1.07 - 2.55 ) and aspartate transaminase/alanine transaminase ratio ≥1.6 ( HR , 1.82 ; 95 % CI , 1.23 - 2.70 ) were independent predictors of suboptimal adherence . Compared with those with optimal adherence , patients with suboptimal adherence had a more advanced HCC stage at diagnosis ( P=0.015 ) , they were less frequently treated with curative intention ( P=0.078 ) and survived less ( median : 14.2 mo ; IQR : 36.0 vs. 22.7 mo ; IQR : 47.4 ; P=0.160 ) , although these differences were not significant . Conclusions : The adherence to the process of HCC surveillance can be considered as adequate among cirrhotic patients . Active alcohol consumption and a history of intravenous drug use are the strongest predictors of suboptimal adherence . These patients have a more advanced HCC stage at diagnosis and tend to be less frequently treated with curative intention BACKGROUND & AIMS We performed a prospect i ve study to investigate the effects of a sustained viral response ( SVR ) on outcomes of patients with hepatitis C virus ( HCV ) infection and compensated cirrhosis . METHODS We collected data from 1323 patients included in the prospect i ve Agence Nationale pour la Recherche sur le SIDA et les hépatites virales ( ANRS ) viral cirrhosis ( CirVir ) cohort , recruited from 35 clinical centers in France from 2006 through 2012 . All patients had HCV infection and biopsy-proven cirrhosis , were Child-Pugh class A , and had no prior liver complications . All patients received anti-HCV treatment before or after inclusion ( with interferon then with direct antiviral agents ) and underwent an ultrasound examination every 6 months , as well as endoscopic evaluations . SVR was considered as a time-dependent covariate ; its effect on outcome was assessed by the Cox proportional hazard regression method . We used a propensity score to minimize confounding by indication of treatment and capacity to achieve SVR . RESULTS After a median follow-up period of 58.2 months , 668 patients ( 50.5 % ) achieved SVR . SVR was associated with a decreased incidence of hepatocellular carcinoma ( hazard ratio [ HR ] compared with patients without an SVR , 0.29 ; 95 % confidence interval [ CI ] , 0.19 - 0.43 ; P < .001 ) and hepatic decompensation ( HR , 0.26 ; 95 % CI , 0.17 - 0.39 ; P < .001 ) . Patients with SVRs also had a lower risk of cardiovascular events ( HR , 0.42 ; 95 % CI , 0.25 - 0.69 ; P = .001 ) and bacterial infections ( HR , 0.44 ; 95 % CI , 0.29 - 0.68 ; P < .001 ) . Metabolic features were associated with a higher risk of hepatocellular carcinoma in patients with SVRs , but not in patients with viremia . SVR affected overall mortality ( HR , 0.27 compared with patients without SVR ; 95 % CI , 0.18 - 0.42 ; P < .001 ) and death from liver-related and non-liver-related causes . Similar results were obtained in a propensity score-matched population . CONCLUSIONS We confirmed a reduction in critical events , liver-related or not , in a prospect i ve study of patients with HCV infection and compensated cirrhosis included in the CirVir cohort who achieved an SVR . We found an SVR to reduce overall mortality and risk of death from liver-related and non-liver-related causes . A longer follow-up evaluation is required to accurately describe and assess specific risk factors for complications in this population BACKGROUND Gastrointestinal haemorrhage from ruptured esophageal varices ( EV ) is a significant cause of morbidity and mortality in patients with HCV-related cirrhosis . The risk of developing EV and bleeding is influenced by hepatitis severity , which can be attenuated by successful interferon ( IFN ) therapy . Our aim was to prospect ively assess whether a successful IFN therapy modifies development and /or progression of EV in patients with HCV-related compensated cirrhosis . METHODS Child-Pugh A patients with either no or small ( F1 ) EV underwent surveillance with repeated endoscopy during and after completion of IFN-based therapy . RESULTS A total of 127 patients ( 59 years , 79 males , 65 HCV-1/4 and 17 F1 EV ) received weight-based ribavirin ( RBV ) combined with either IFN-α2b 3 MU three times per week ( n=36 ) , weekly pegylated (PEG)-IFN-α2b 1.5 μg/kg ( n=68 ) or weekly PEG-IFN-α2a 180 μg ( n=23 ) . Patients were followed-up for 18 - 108 months after treatment completion with a median endoscopic follow-up of 68 months for the 62 patients with a sustained virological response ( SVR ) and 57 months for the 65 non-SVR patients ( P=0.3 ) . De novo EV developed in 10 ( 9.1 % ) patients including 2/57 SVR and 8/53 non-SVR ( 3.5 % versus 15.1 % ; P=0.047 ) , whereas EV progressed in size in 3 patients , including 1/5 SVR and 2/12 non-SVR ( P=0.87 ) . Two non-SVR patients bled from EV and one died . CONCLUSIONS A successful IFN therapy prevents or delays the de novo onset of EV in patients with compensated cirrhosis due to HCV , but does not abrogate the need for continued endoscopic surveillance Chronic hepatitis C virus ( HCV ) infection with advanced cirrhosis or post‐liver transplantation recurrence represents a high unmet medical need with no approved therapies effective across all HCV genotypes . The open‐label ALLY‐1 study assessed the safety and efficacy of a 60‐mg once‐daily dosage of daclatasvir ( pan‐genotypic NS5A inhibitor ) in combination with sofosbuvir at 400 mg once daily ( NS5B inhibitor ) and ribavirin at 600 mg/day for 12 weeks with a 24‐week follow‐up in two cohorts of patients with chronic HCV infection of any genotype and either compensated/decompensated cirrhosis or posttransplantation recurrence . Patients with on‐treatment transplantation were eligible to receive 12 additional weeks of treatment immediately after transplantation . The primary efficacy measure was sustained virologic response at posttreatment week 12 ( SVR12 ) in patients with a genotype 1 infection in each cohort . Sixty patients with advanced cirrhosis and 53 with posttransplantation recurrence were enrolled ; HCV genotypes 1 ( 76 % ) , 2 , 3 , 4 , and 6 were represented . Child‐Pugh classifications in the advanced cirrhosis cohort were 20 % A , 53 % B , and 27 % C. In patients with cirrhosis , 82 % ( 95 % confidence interval [ CI ] , 67.9%‐92.0 % ) with genotype 1 infection achieved SVR12 , whereas the corresponding rates in those with genotypes 2 , 3 , and 4 were 80 % , 83 % , and 100 % , respectively ; SVR12 rates were higher in patients with Child‐Pugh class A or B , 93 % , versus class C , 56 % . In transplant recipients , SVR12 was achieved by 95 % ( 95 % CI , 83.5%‐99.4 % ) and 91 % of patients with genotype 1 and 3 infection , respectively . Three patients received peritransplantation treatment with minimal dose interruption and achieved SVR12 . There were no treatment‐related serious adverse events . Conclusion : The pan‐genotypic combination of daclatasvir , sofosbuvir , and ribavirin was safe and well tolerated . High SVR rates across multiple HCV genotypes were achieved by patients with post‐liver transplantation recurrence or advanced cirrhosis . ( Hepatology 2016;63:1493‐1505 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 and Aims : A sustained virological response ( SVR ) decreases the incidence of hepatocellular carcinoma ( HCC ) in patients with hepatitis C. We investigated the long-term outcomes of patients who developed HCC after achieving SVR with interferon therapy . Patients : Of 75 patients who developed HCC after SVR , 40 patients underwent radical therapies ( SVR group ) . From 436 patients undergoing surgical resection for hepatitis C virus-positive HCC , 80 patients were r and omly chosen as a control cohort , after adjusting for age , gender , and extent of hepatic fibrosis ( non-SVR group ) . Patients were observed for a median of 5.08 years . Results : HCC recurrence was found in 16 SVR patients and in 66 non-SVR patients . The respective HCC recurrence rates of SVR and non-SVR patients were 23 and 56 % at 3 years , 42 and 77 % at 5 years , and 53 and 90 % at 10 years ( p = 0.001 ) . The respective overall survival rates in the SVR and non-SVR groups were 93 and 68 % at 5 years , 88 and 34 % at 10 years , and 53 and 21 % at 15 years ( p = 0.001 ) . Conclusion : Although SVR patients had a significantly lower HCC recurrence rate than the non-SVR patients , the cumulative recurrence rate of SVR patients increased to 86 % at 15 years Background Novel direct-acting antivirals ( DAAs ) have completely changed the panorama of hepatitis C due to their high efficacy and optimal safety profile . Unfortunately , an unexpectedly high rate of early recurrence of hepatocellular carcinoma has been reported within weeks of starting treatment , but the mechanism is not known . Methods We monitored the serum level of vascular endothelial growth factor ( VEGF ) and changes in the pattern of circulating interleukins in 103 chronic hepatitis C patients during antiviral treatment with DAA-regimens . VEGF , epidermal growth factor ( EGF ) , and several interleukins were assessed at baseline , during treatment , and after treatment . The biological effect of DAA-treated patient serum on human umbilical vein endothelial cell ( HUVEC ) proliferation was also confirmed . Results After 4 weeks of therapy , VEGF increased approximately 4-fold compared to baseline , remained elevated up to the end of treatment , and returned to the pre-treatment level after the end of therapy . In contrast , interleukin-10 and tumor necrosis factor-alpha significantly decreased during therapy , which was coincident with HCV clearance . The levels of both remained low after treatment . The addition of serum from patients collected during therapy induced HUVEC proliferation ; however , this disappeared after the end of therapy . Conclusions DAA administration induces an early increase in serum VEGF and a change in the inflammatory pattern , coinciding with HCV clearance . This may alter the balance between inflammatory and anti-inflammatory processes and modify the antitumor surveillance of the host . Fortunately , such modifications return reverse to normal after the end of treatment BACKGROUND Interferon-containing regimens for the treatment of hepatitis C virus ( HCV ) infection are associated with increased toxic effects in patients who also have cirrhosis . We evaluated the interferon-free combination of the protease inhibitor ABT-450 with ritonavir ( ABT-450/r ) , the NS5A in
Output:
| There is no evidence for differential HCC occurrence or recurrence risk following SVR from DAA and IFN-based therapy .
There is no evidence that HCC occurrence or recurrence is different between patients receiving DAA or IFN therapy |
MS211445 | ***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 effect of extensive lymphadenectomy on survival in patients with gastric cancer . DESIGN Retrospective analysis SETTING University Hospital , Norway . SUBJECTS 183 patients with stomach cancer resected for cure during the time period 1980 - 90 . INTERVENTIONS 78 patients had an R1- and 105 patients and R2 resection . 124 patients were treated by total gastrectomy , 5 by proximal-- and 54 by distal resection . MAIN OUTCOME MEASURES Morbidity , mortality and long term survival . RESULTS The morbidity was 33 % ( 60/183 ) , of which 39 ( 21 % ) were general complications ( pneumonia , thrombosis , or cardiovascular disease ) . 14 patients died postoperatively ( 8 % ) . By logistic regression analysis we found that splenectomy was the only variable associated with both morbidity and immediate postoperative mortality . Five year survival was 39 % for patients who had undergone curative resections , 30 % for patients who had had an R1 resection , and 47 % for those who had had an R2 resection . By multivariate analysis ( Cox ) we found that N-classification ( TNM ) , tumour diameter of less than 45 mm , type of lymph node dissection ( R2 ) and operation period ( after 1984 ) correlated with improved survival . CONCLUSION Extensive lymph node dissection improves survival without increasing morbidity or postoperative mortality BACKGROUND In Japan the surgical approach to treatment of potentially curable gastric cancer , including extended lymphadenectomy , seems in retrospective surveys to give better results than the less radical procedures favoured in Western countries . There has , however , been no evidence from r and omised trials that extended lymphadenectomy ( D2 gastric resection ) confers a survival advantage . This question was addressed in a trial involving thirty-two surgeons in Europe . METHODS In a prospect i ve r and omised controlled trial , D1 resection ( level 1 lymphadenectomy ) was compared with D2 resection ( levels 1 and 2 lymphadenectomy ) . Central r and omisation ( 200 patients in each arm ) followed a staging laparotomy . FINDINGS The D2 group had greater postoperative hospital mortality ( 13 % vs 6.5 % ; p=0.04 [ 95 % Cl 9 - 18 % for D2 , 4 - 11 % for D1 ] and higher overall postoperative morbidity ( 46 % vs 28 % ; p<0.001 ) ; their postoperative stay was also longer . The excess postoperative morbidity and mortality in the D2 group was accounted for by distal pancreaticosplenectomy and splenectomy . In the whole group ( 400 patients ) , survival beyond three years was 30 % in patients whose gastrectomy included en-bloc pancreatico-splenic resection versus 50 % in the remainder . INTERPRETATION D2 gastric resections are followed by higher morbidity and mortality than D1 resections . These disadvantages are consequent upon additional pancreatectomies and distal splenectomies , and in long-term follow-up the higher mortality when the pancreas and spleen are resected may prove to nullify any survival benefit from D2 procedures A r and omized clinical trial was performed to compare D1 and D2 gastrectomy in specialized Western centres . This paper reports short‐term results The contention that the R2 radical gastrectomy for localized and potentially curable gastric carcinoma may be superior to gastrectomy without lymphadenectomy ( R1 ) was assessed by r and omized trial . Five years after commencement 403 patients have been evaluated at surgery and only 43 ( 11 per cent ) found eligible ( S0–2 , P0 , H0 , N0–1 ) , 22 of whom underwent R1 and 21 R2 gastrectomy . Seven patients had final histological stages in excess of the protocol . The R2 group had a longer operating time ( P<0.005 ) , a greater blood transfusion requirement ( P<0.005 ) , a longer hospital stay ( 0.05>P>0.025 ) and required reoperation in four cases . There were no postoperative deaths . Four patients have died from the disease in the R1 group and five in the R2 group , there being no difference in the probability of survival at a median follow‐up of 3.1 years . The small proportion of patients suitable for radical R2 surgery , the high associated morbidity and the fact that survival advantage has yet to be proven in trial suggest that this procedure should not yet be performed outside of controlled clinical trials Background : Studies have shown that the survival of patients with gastric adenocarcinoma is related to the number of regional lymph nodes with metastases . The probability of identifying node-positive cancers increases with the number of lymph nodes resected and examined . It has been recommended that at least 15 lymph nodes be removed and examined for adequate staging . Prospect i ve r and omized studies have shown the lymph node yield is much greater with the D2 resection than the D1 . This study evaluated the relative contribution of both the number of resected lymph nodes and the extent of gastric resection ( D1/D2 ) on the outcome of patients with proximal gastric cancer . Methods : The medical records of 114 patients with adenocarcinoma of the proximal stomach , who underwent a curative gastric resection , were review ed . Patients were stratified into four groups , i.e. , two groups , D1/D1.5 and D2/D2.5 , based on the extent of resection , and two groups based on the number of lymph nodes removed , fewer than 15 lymph nodes and 15 or more lymph nodes . Survival was determined by the method of Kaplan-Meier and differences compared by the log-rank test . Multivariate analysis was performed by using the Cox model . Results : The number of resected lymph nodes had no effect on the survival of the group as a whole . A significant improvement in survival was noted for patients with a D2 or greater resection . The median survival of patients with 15 or more lymph nodes resected improved from 25 months to 42 months when treated with an extended resection , ( D2 or D2.5 ) . Resection of 15 or more lymph nodes alone , or combined with an extended resection , result ed in a statistically significant improvement in survival for patients in American Joint Committee on Cancer Staging ( AJCC ) stage II . Conclusions : Both resection of 15 or more lymph nodes and extended lymphadenectomy contributed to the survival advantage observed in patients with AJCC stage II gastric cancer . The D2 gastric resection prolonged the median survival time and improved the 5-year survival rate for patients with 15 or more resected lymph nodes BACKGROUND A multicenter , r and omized , clinical trial was initiated to evaluate the possible benefits of extended D2 ( D2 + ) lymphadenectomy after potentially curative resection of gastric cancer . METHODS St and ard D2 lymphadenectomy was defined according to the Japanese Gastric Cancer Association classification . D2 + lymph node dissection additionally included the removal of para-aortic nodes . RESULTS Of 781 patients screened , 275 were r and omized to st and ard D2 ( n = 141 ) or extended D2 + ( n = 134 ) lymphadenectomy . The overall morbidity rates were comparable in D2 ( 27.7 % ; 95 % confidence interval [ CI ] , 20.3 - 35.1 ) and D2 + ( 21.6 % ; 95 % CI , 13.7 - 29.5 ) groups ( P = .248 ) . Pre-existing cardiac disease , splenectomy , and excessive blood loss were identified as risk factors for overall and nonsurgical complications . Postoperative mortality rates were 4.9 % ( 95 % CI , 1.4 - 8.5 ) and 2.2 % ( 95 % CI , 0 - 4.7 ) , respectively ( P = .376 ) . CONCLUSIONS The interim safety analysis failed to show any significant difference with regard to the extent of lymph node dissection . The surgical outcome was not different between the 2 surgeries PURPOSE In the tumor-node-metastasis ( TNM ) staging system , no recommendations are provided on what lymph node retrieval technique is to be used to determine lymph node status , which leads to variability in nodal status assessment and TNM staging . PATIENT AND METHODS Lymph node retrieval was quantitated using data from 237 curatively resected gastric cancer patients , from a prospect i ve , r and omized trial that compared the Western resection with limited ( D1 ) and the Japanese resection with extended lymphadenectomy ( D2 ) , and compared data from the literature . Moreover , the efficacy of different lymph node retrieval techniques was determined . RESULTS The mean yield of lymph nodes was 15 in D1 and 30 in D2 , which is similar to results from German investigators , but substantially lower than results from Japanese investigators ( 60 in D2 ) . Use of a fat-clearance technique significantly increased ( P = .01 ) nodal yields compared with conventional retrieval . Significantly higher yields ( P < .001 ) were obtained by a Japanese surgeon using conventional retrieval directly postoperatively . Experience of surgicopathologic teams with processing resection specimens did not influence nodal yields . Further analysis showed that reference values for nodal yields per anatomically defined station as reported in the literature were contradicted by our results and indicated the ambiguity of such st and ards . CONCLUSION Despite some anatomical variability in the distribution of lymph nodes , advice on the number of nodes to examine per N level , feasible in all patients , should be incorporated into the TNM classification to st and ardize nodal status assessment . Based on our findings , we advocate retrieval of nodes immediately postoperatively by the surgeon PURPOSE Radical gastrectomy with regional lymphadenectomy is the only curative treatment option for gastric cancer . The extent of lymphadenectomy , however , is controversial . The two European r and omized trials only reported an increase in operative morbidity and mortality , but failed to show survival benefit , in the D2 lymphadenectomy group . We conducted a r and omized controlled trial to compare the Japanese st and ard D2 and D2 + para-aortic nodal dissection . PATIENTS AND METHODS Only experienced surgeons in both procedures from 24 Japanese institutions participated in the study . Patients with potentially curable gastric adenocarcinoma ( T2-subserosa , T3 , or T4 ) who were surgically fit were intraoperatively r and omized . Postoperative morbidity and hospital mortality were recorded prospect ively in a fixed format and were compared between the two groups in this study . RESULTS A total of 523 patients were r and omized between July 1995 and April 2001 . Postoperative complications were reported in 24.5 % of all patients . Although the morbidity for the extended surgery group ( 28.1 % ) was slightly higher than the st and ard group ( 20.9 % ) , there was no difference in the incidence of four major complications ( anastomotic leak , pancreatic fistula , abdominal abscess , pneumonia ) between the two groups . Hospital mortality was reported at 0.80 % : one patient in each group died of operative complications , while one from each group died of rapid progressive cancer while inpatient . CONCLUSION Specialized surgeons could safely perform gastrectomy with D2 lymphadenectomy in patients with low operative risks . Para-aortic lymphadenectomy could be added without increasing major surgical complications in this setting It is still unclear whether D2 lymphadenectomy improves the survival of patients with gastric cancer and should therefore be performed routinely or selectively . The aim of this multicentre r and omized trial was to compare D2 and D1 lymphadenectomy in the treatment of gastric cancer BACKGROUND Gastrectomy with D2 lymphadenectomy is the st and ard treatment for curable gastric cancer in eastern Asia . Whether the addition of para-aortic nodal dissection ( P AND ) to D2 lymphadenectomy for stage T2 , T3 , or T4 tumors improves survival is controversial . We conducted a r and omized , controlled trial at 24 hospitals in Japan to compare D2 lymphadenectomy alone with D2 lymphadenectomy plus P AND in patients undergoing gastrectomy for curable gastric cancer . METHODS Between July 1995 and April 2001 , 523 patients with curable stage T2b , T3 , or T4 gastric cancer were r and omly assigned during surgery to D2 lymphadenectomy alone ( 263 patients ) or to D2 lymphadenectomy plus P AND ( 260 patients ) . We did not permit any adjuvant therapy before the recurrence of cancer . The primary end point was overall survival . RESULTS The rates of surgery-related complications among patients assigned to D2 lymphadenectomy alone and those assigned to D2 lymphadenectomy plus P AND were 20.9 % and 28.1 % , respectively ( P=0.07 ) . There were no significant differences between the two groups in the frequencies of anastomotic leakage , pancreatic fistula , abdominal abscess , pneumonia , or death from any cause within 30 days after surgery ( the rate of death was 0.8 % in each group ) . The median operation time was 63 minutes longer and the median blood loss was 230 ml greater in the
Output:
| D2 lymphadenectomy can improve DSS in patients with resectable carcinoma of the stomach , although the increased incidence of postoperative mortality reduces its therapeutic benefit |
MS211446 | ***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 Encouraging office workers to ‘ sit less and move more ’ encompasses two public health priorities . However , there is little evidence on the effectiveness of workplace interventions for reducing sitting , even less about the longer term effects of such interventions and still less on dual-focused interventions . This study assessed the short and mid-term impacts of a workplace web-based intervention ( Walk@WorkSpain , W@WS ; 2010 - 11 ) on self-reported sitting time , step counts and physical risk factors ( waist circumference , BMI , blood pressure ) for chronic disease . Methods Employees at six Spanish university campuses ( n=264 ; 42±10 years ; 171 female ) were r and omly assigned by worksite and campus to an Intervention ( used W@WS ; n=129 ; 87 female ) or a Comparison group ( maintained normal behavior ; n=135 ; 84 female ) . This phased , 19-week program aim ed to decrease occupational sitting time through increased incidental movement and short walks . A linear mixed model assessed changes in outcome measures between the baseline , ramping ( 8 weeks ) , maintenance ( 11 weeks ) and follow-up ( two months ) phases for Intervention versus Comparison groups . Results A significant 2 ( group ) × 2 ( program phases ) interaction was found for self-reported occupational sitting ( F[3]=7.97 , p=0.046 ) , daily step counts ( F[3]=15.68 , p=0.0013 ) and waist circumference ( F[3]=11.67 , p=0.0086 ) . The Intervention group decreased minutes of daily occupational sitting while also increasing step counts from baseline ( 446±126 ; 8,862±2,475 ) through ramping ( + 425±120 ; 9,345±2,435 ) , maintenance ( + 422±123 ; 9,638±3,131 ) and follow-up ( + 414±129 ; 9,786±3,205 ) . In the Comparison group , compared to baseline ( 404±106 ) , sitting time remained unchanged through ramping and maintenance , but decreased at follow-up ( -388±120 ) , while step counts diminished across all phases . The Intervention group significantly reduced waist circumference by 2.1cms from baseline to follow-up while the Comparison group reduced waist circumference by 1.3cms over the same period . Conclusions W@WS is a feasible and effective evidence -based intervention that can be successfully deployed with sedentary employees to elicit sustained changes on “ sitting less and moving more ” Background Excessive sitting time is a risk factor for cardiovascular disease mortality and morbidity independent of physical activity . This aim of this study was to evaluate the impact of a sit-st and workstation on sitting time , and vascular , metabolic and musculoskeletal outcomes in office workers , and to investigate workstation acceptability and feasibility . Methods A two-arm , parallel-group , individually r and omised controlled trial was conducted in one organisation . Participants were asymptomatic full-time office workers aged ≥18 years . Each participant in the intervention arm had a sit-st and workstation installed on their workplace desk for 8 weeks . Participants in the control arm received no intervention . The primary outcome was workplace sitting time , assessed at 0 , 4 and 8 weeks by an ecological momentary assessment diary . Secondary behavioural , cardiometabolic and musculoskeletal outcomes were assessed . Acceptability and feasibility were assessed via question naire and interview . ANCOVA and magnitude-based inferences examined intervention effects relative to controls at 4 and 8 weeks . Participants and research ers were not blind to group allocation . Results Forty-seven participants were r and omised ( intervention n = 26 ; control n = 21 ) . Relative to the control group at 8 weeks , the intervention group had a beneficial decrease in sitting time ( −80.2 min/8-h workday ( 95 % CI = −129.0 , −31.4 ) ; p = 0.002 ) , increase in st and ing time ( 72.9 min/8-h workday ( 21.2 , 124.6 ) ; p = 0.007 ) and decrease in total cholesterol ( −0.40 mmol/L ( −0.79 , −0.003 ) ; p = 0.049 ) . No harmful changes in musculoskeletal discomfort/pain were observed relative to controls , and beneficial changes in flow-mediated dilation and diastolic blood pressure were observed . Most participants self-reported that the workstation was easy to use and their work-related productivity did not decrease when using the device . Factors that negatively influenced workstation use were workstation design , the social environment , work tasks and habits . ConclusionS hort-term use of a feasible sit-st and workstation reduced daily sitting time and led to beneficial improvements in cardiometabolic risk parameters in asymptomatic office workers . These findings imply that if the observed use of the sit-st and workstations continued over a longer duration , sit-st and workstations may have important ramifications for the prevention and reduction of cardiometabolic risk in a large proportion of the working population .Trial registration Clinical Trials.gov NCT02496507 Background Prolonged sitting time has been associated with adverse health outcomes . Interventions at work may contribute to reduced sitting . The objective was to test if a multicomponent work-based intervention can reduce sitting time and the number of prolonged sitting periods ( > 30 min ) , increase the number of sit-to-st and transitions and decrease waist circumference and body fat percentage among office workers . Primary outcomes were : change in sitting time , prolonged sitting periods and sit-to-st and transitions at follow-up 1 month later . Methods At four workplaces , 19 offices ( 317 workers in total ) were cluster r and omized for intervention or control . The intervention included the appointment of local ambassadors , management support , environmental changes , a lecture and a workshop . Sitting time was measured using an ActiGraph GT3X+ fixed on the thigh . Data were processed using Acti4 software providing data on time spent sitting , st and ing and doing other activities . Control participants were instructed to behave as usual . Follow-up measurements were obtained after 1 and 3 months . Results At 1 and 3 months , total sitting time was 71 ( P < 0.001 ) and 48 min ( P < 0.001 ) lower per 8-h workday in the intervention group compared with the control group . At 1 month , the number of prolonged sitting periods was lower ( -0.79/8-h workday , P < 0.001 ) and sit-to-st and transitions were higher ( + 14%/sitting hour , P = 0.001 ) in the intervention compared with the control group . After 3 months , trends persisted . The body fat percentage was lower by 0.61 percentage points ( P = 0.011 ) in the intervention group compared with the control group after 3 months . Conclusions The multicomponent workplace-based intervention was effective in reducing sitting time , prolonged sitting periods and body fat percentage , and in increasing the number of sit-to-st and transitions 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 Objective : To evaluate the effectiveness of a 3-month treadmill desk intervention in eliciting changes in physical activity and sedentary behavior among overweight/obese office workers . Methods : A r and omized controlled trial was conducted among overweight/obese office workers ( n = 41 ; mean age = 40.1 ± 10.1 years ) at a private workplace . Participants were r and omly assigned to a shared-treadmill desk intervention ( n = 21 ) or a usual working condition control group ( n = 20 ) . Accelerometer-determined physical activity and sedentary behavior were measured before and after the intervention . Results : Compared with the control group , the intervention group increased daily steps ( 1622 steps/day ; P = 0.013 ) and light physical activity ( 1.6 minutes/hour ; P = 0.008 ) , and decreased sedentary time ( −3.6 minutes/hour ; P = 0.047 ) during working hours . Conclusions : Shared-treadmill desks in the workplace can be effective at promoting favorable changes in light physical activity ( specifically 40 to 99 steps/minute ) and sedentary behavior among overweight/obese office workers Background Prolonged sitting time is detrimental for health . Individuals with desk-based occupations tend to sit a great deal and sit-st and workstations have been identified as a potential strategy to reduce sitting time . Hence , the objective of the current study was to examine the effects of using sit-st and workstations on office workers ’ sitting time at work and over the whole day . Methods We conducted a r and omized controlled trial pilot with crossover design and waiting list control in Sydney , Australia from September 2011 to July 2012 ( n = 42 ; 86 % female ; mean age 38 ± 11 years ) . Participants used a sit-st and workstation for four weeks in the intervention condition . In the time-matched control condition , participants received nothing and crossed over to the intervention condition after four weeks . The primary outcomes , sitting , st and ing and walking time at work , were assessed before and after using the workstations with ActivPALs and self-report question naires . Secondary outcomes , domain-specific sitting over the whole day , were assessed by self-report . Linear mixed models estimated changes in outcomes adjusting for measurement time , study grouping and covariates . Results Intervention participants significantly reduced objective ly assessed time spent sitting at work by 73 min/workday ( 95 % CI : -106,-39 ) and increased st and ing time at work by 65 min/workday ( 95 % CI : 47 , 83 ) ; these changes were significant relative to controls ( p = 0.004 and p < 0.001 , respectively ) . Total sitting time significantly declined in intervention participants ( -80 min/workday ; 95 % CI : -155 , -4 ) . Conclusions This study shows that introducing sit-st and workstations in the office can reduce desk-based workers ’ sitting time at work in the short term . Larger scale studies on more representative sample s are needed to determine the public health impact of sit-st and workstations . Trial registration Background Interventions design ed to increase workplace physical activity may not automatically reduce high volumes of sitting , a behaviour independently linked to chronic diseases such as obesity and type II diabetes . This study compared the impact two different walking strategies had on step counts and reported sitting times . Methods Participants were white-collar university employees ( n = 179 ; age 41.3 ± 10.1 years ; 141 women ) , who volunteered and undertook a st and ardised ten-week intervention at three sites . Pre-intervention step counts ( Yamax SW-200 ) and self-reported sitting times were measured over five consecutive workdays . Using pre-intervention step counts , employees at each site were r and omly allocated to a control group ( n = 60 ; maintain normal behaviour ) , a route-based walking group ( n = 60 ; at least 10 minutes sustained walking each workday ) or an incidental walking group ( n = 59 ; walking in workday tasks ) . Workday step counts and reported sitting times were re-assessed at the beginning , mid- and endpoint of intervention and group mean± SD steps/day and reported sitting times for pre-intervention and intervention measurement points compared using a mixed factorial ANOVA ; paired sample -t-tests were used for follow-up , simple effect analyses . Results A significant interactive effect ( F = 3.5 ; p < 0.003 ) was found between group and step counts . Daily steps for controls decreased over the intervention period ( -391 steps/day ) and increased for route ( 968 steps/day ; t = 3.9 , p < 0.000 ) and incidental ( 699 steps/day ; t = 2.5 , p < 0.014 ) groups . There were no significant changes for reported sitting times , but average values did decrease relative to the control ( routes group = 7 minutes/day ; incidental group = 15 minutes/day ) . Reductions were most evident for the incidental group in the first week of intervention , where reported sitting decreased by an average of 21 minutes/day ( t = 1.9 ; p < 0.057 ) . Conclusion Compared to controls , both route and incidental walking increased physical activity in white-collar employees . Our data suggests that workplace walking , particularly through incidental movement , also has the potential to decrease employee sitting times , but there is a need for on-going research using concurrent and objective measures of sitting , st and ing and walking Objective : This study was conducted to determine whether installation of sit-st and desks ( SSDs ) could lead to decreased sitting time during the workday among sedentary office workers . Methods : A r and omized cross-over trial was conducted from January to April , 2012 at a business in Minneapolis . 28 ( nine men , 26 full-time ) sedentary office workers took part in a 4 week intervention period which included the use of SSDs to gradually replace 50 % of sitting time with st and ing during the workday . Physical activity was the primary outcome . Mood , energy level , fatigue , appetite , dietary intake , and productivity were explored as secondary outcomes . Results : The intervention reduced sitting time at work by 21 % ( 95 % CI 18%–25 % ) and sedentary time by 4.8 min/work-hr ( 95 % CI 4.1–5.4 min/work-hr ) . For a 40 h work-week ,
Output:
| Furthermore , interventions focusing on sedentary behaviour only and studies using objective measurement tools showed more often positive interventions effects .
Conclusions There are many promising interventions to reduce sitting time at the office workplace .
However , there is insufficient evidence if the effects of these interventions are sustainable in the long term . |
MS211447 | ***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: Two recent sham-controlled studies found that transcranial direct current stimulation ( tDCS ) was an effective treatment for depression . As tDCS is painless , relatively safe and inexpensive , its efficacy in treating depression warrants further investigation . This double-blind , r and omized study tested tDCS at the same stimulation parameters as a previous positive study ( 1 mA current strength , five treatment sessions , active or sham , given on alternate days ) in 40 depressed participants . Anodal stimulation was centred over the left dorsolateral prefrontal cortex , with the cathode placed on the lateral aspect of the contralateral orbit . tDCS was continued up to a total of ten active sessions per participant . Mood outcomes were measured by psychiatrist raters blind to treatment condition using the Montgomery-Asberg and other depression rating scales . Psychomotor speed was assessed immediately before and after a single tDCS session and attention , frontal executive function , working memory and verbal learning were assessed after each group of five sessions . Overall depression scores improved significantly over ten tDCS treatments , but there was no between-group difference in the five-session , sham-controlled phase . tDCS was found to be safe , with no adverse effects on neuropsychological function , and only minor side-effects . It is recommended that the efficacy of tDCS in depression be further evaluated over a longer treatment period , using enhanced stimulation parameters BACKGROUND Transcranial direct current stimulation ( tDCS ) is a non-invasive brain stimulation modality that has been increasingly used for major depressive disorder ( MDD ) treatment . Although studies in healthy volunteers showed that the technique is well-tolerated , tDCS safety and acceptability have not been sufficiently explored in patients with MDD . METHODS We collected individual patient data from 6 r and omized clinical trials that had been previously identified in a systematic review and meta- analysis . Primary outcomes were safety ( rate of adverse events ) and acceptability ( rate of dropouts ) . Secondary outcomes were clinical , demographic and treatment predictors of the primary outcomes . RESULTS Dropout rates between active ( 8.8 % ) and sham ( 12 % ) groups were not significantly different ( OR= 0.7 , p=0.38 ) . Adverse event rates between active ( 73.5 % ) and sham ( 68.3 % ) groups were not significantly different ( OR= 1.4 , p= 0.23 ) . Higher current densities were associated with lower adverse event rates . LIMITATIONS Dropout reasons were not systematic ally reported and adverse events were not collected using question naires st and ardized across studies . CONCLUSIONS Active tDCS is as acceptable and safe as sham tDCS , as found in r and omized clinical trials of MDD Importance More effective , tolerable interventions for bipolar depression treatment are needed . Transcranial direct current stimulation ( tDCS ) is a novel therapeutic modality with few severe adverse events that showed promising results for unipolar depression . Objective To determine the efficacy and safety of tDCS as an add-on treatment for bipolar depression . Design , Setting , and Participants A r and omized , sham-controlled , double-blind trial ( the Bipolar Depression Electrical Treatment Trial [ BETTER ] ) was conducted from July 1 , 2014 , to March 30 , 2016 , at an outpatient , single-center academic setting . Participants included 59 adults with type I or II bipolar disorder in a major depressive episode and receiving a stable pharmacologic regimen with 17-item Hamilton Depression Rating Scale ( HDRS-17 ) scores higher than 17 . Data were analyzed in the intention-to-treat sample . Interventions Ten daily 30-minute , 2-mA , anodal-left and cathodal-right prefrontal sessions of active or sham tDCS on weekdays and then 1 session every fortnight until week 6 . Main Outcomes and Measures Change in HDRS-17 scores at week 6 . Results Fifty-nine patients ( 40 [ 68 % ] women ) , with a mean ( SD ) age of 45.9 ( 12 ) years participated ; 36 ( 61 % ) with bipolar I and 23 ( 39 % ) with bipolar II disorder were r and omized and 52 finished the trial . In the intention-to-treat analysis , patients in the active tDCS condition showed significantly superior improvement compared with those receiving sham ( & bgr;int = −1.68 ; number needed to treat , 5.8 ; 95 % CI , 3.3 - 25.8 ; P = .01 ) . Cumulative response rates were higher in the active vs sham groups ( 67.6 % vs 30.4 % ; number needed to treat , 2.69 ; 95 % CI , 1.84 - 4.99 ; P = .01 ) , but not remission rates ( 37.4 % vs 19.1 % ; number needed to treat , 5.46 ; 95 % CI , 3.38 - 14.2 ; P = .18 ) . Adverse events , including treatment-emergent affective switches , were similar between groups , except for localized skin redness that was higher in the active group ( 54 % vs 19 % ; P = .01 ) . Conclusions and Relevance In this trial , tDCS was an effective , safe , and tolerable add-on intervention for this small bipolar depression sample . Further trials should examine tDCS efficacy in a larger sample . Trial Registration clinical trials.gov Identifier : BACKGROUND Transcranial direct current stimulation ( tDCS ) is a promising new treatment for depression , however , clinical trials to- date indicate variable efficacy , thereby raising the need to identify inter-individual predictors of response . In the current study we aim ed to investigate pre-treatment neurocognitive performance as a predictor of antidepressant response to tDCS . METHODS Data was pooled from five clinical trials , including two r and omised controlled trials ( RCTs ) , which investigated the antidepressant effects of anodal tDCS administered to the prefrontal cortex . Data from 57 patients were included in the analysis . Mood was assessed before and after an acute course of treatment using the Montgomery-Åsberg Depression Rating Scale . The following neurocognitive tests were administered prior to treatment : Simple and choice reaction time , the Symbol Digit Modalities Test ( SDMT ) , Rey Auditory Verbal Memory Task ( RAVLT ) , Digit Span , and the Controlled Oral Word Association Test ( COWAT ) . RESULTS Better pre-treatment letter fluency performance measured using the COWAT predicted antidepressant response to tDCS after controlling for confounds . LIMITATIONS Small sample size and analysis included data from both RCTs and open label studies . CONCLUSION Pre-treatment letter fluency performance , an ability subserved by the left prefrontal cortex , the primary site of stimulation , is a predictor of response for tDCS treatment for depression . This study highlights the importance of inter-individual neurobiological differences in mediating tDCS antidepressant effects Serotonin affects memory formation via modulating long-term potentiation ( LTP ) and depression ( LTD ) . Accordingly , acute selective serotonin reuptake inhibitor ( SSRI ) administration enhanced LTP-like plasticity induced by transcranial direct current stimulation ( tDCS ) in humans . However , it usually takes some time for SSRI to reduce clinical symptoms such as anxiety , negative mood , and related symptoms of depression and anxiety disorders . This might be related to an at least partially different effect of chronic serotonergic enhancement on plasticity , as compared with single-dose medication . Here we explored the impact of chronic application of the SSRI citalopram ( CIT ) on plasticity induced by tDCS in healthy humans in a partially double-blinded , placebo (PLC)-controlled , r and omized crossover study . Furthermore , we explored the dependency of plasticity induction from the glutamatergic system via N-methyl-D-aspartate receptor antagonism . Twelve healthy subjects received PLC medication , combined with anodal or cathodal tDCS of the primary motor cortex . Afterwards , the same subjects took CIT ( 20 mg/day ) consecutively for 35 days . During this period , four additional interventions were performed ( CIT and PLC medication with anodal/cathodal tDCS , CIT and dextromethorphan ( 150 mg ) with anodal/cathodal tDCS ) . Plasticity was monitored by motor-evoked potential amplitudes elicited by transcranial magnetic stimulation . Chronic application of CIT increased and prolonged the LTP-like plasticity induced by anodal tDCS for over 24 h , and converted cathodal tDCS-induced LTD-like plasticity into facilitation . These effects were abolished by dextromethorphan . Chronic serotonergic enhancement results in a strengthening of LTP-like glutamatergic plasticity , which might partially explain the therapeutic impact of SSRIs in depression and other neuropsychiatric diseases BACKGROUND Major depressive disorder ( MDD ) is frequently associated with underactivity of the dorsolateral prefrontal cortex ( DLPFC ) which has led to this brain region being identified as an important target for the development of neurobiological treatments . Transcranial direct current stimulation ( tDCS ) administered to the DLPFC has antidepressant efficacy , however the magnitude of antidepressant outcomes are limited . Concurrent cognitive activity has been shown to enhance tDCS induced stimulation effects . Cognitive control training ( CCT ) is a new cognitive therapy for MDD that aims to enhance DLPFC activity via behavioral methods . HYPOTHESIS We tested the hypothesis that co-administration of DLPFC tDCS and CCT would result in a greater reduction in depressive symptomology than administration of tDCS or CCT alone . METHODS 27 adult participants with MDD were r and omized into a three-arm sham-controlled between-groups pilot study comparing the efficacy of 2 mA tDCS + CCT , sham tDCS + CCT and sham CCT + 2 mA tDCS ( 5 sessions administered on consecutive working days ) . Blinded assessment s of depression severity and cognitive control were conducted at baseline , end of treatment and a three week follow up review . RESULTS All three treatment conditions were associated with a reduction in depression severity at the end of five treatment sessions . However , only administration of tDCS + CCT result ed in sustained antidepressant response at follow up , the magnitude of which was greater than that observed immediately following conclusion of the treatment course . CONCLUSIONS The results provide preliminary evidence that concurrent CCT enhances antidepressant outcomes from tDCS . In the current sample , participants receiving concurrent tDCS and CCT continued to improve following cessation of treatment . The clinical superiority of a combined therapeutic approach was apparent even in a small sample and following a relatively short treatment course BACKGROUND We compared transcranial direct‐current stimulation ( tDCS ) with a selective serotonin‐reuptake inhibitor for the treatment of depression . METHODS In a single‐center , double‐blind , noninferiority trial involving adults with unipolar depression , we r and omly assigned patients to receive tDCS plus oral placebo , sham tDCS plus escitalopram , or sham tDCS plus oral placebo . The tDCS was administered in 30‐minute , 2‐mA prefrontal stimulation sessions for 15 consecutive weekdays , followed by 7 weekly treatments . Escitalopram was given at a dose of 10 mg per day for 3 weeks and 20 mg per day thereafter . The primary outcome measure was the change in the 17‐item Hamilton Depression Rating Scale ( HDRS‐17 ) score ( range , 0 to 52 , with higher scores indicating more depression ) . Noninferiority of tDCS versus escitalopram was defined by a lower boundary of the confidence interval for the difference in the decreased score that was at least 50 % of the difference in the scores with placebo versus escitalopram . RESULTS A total of 245 patients underwent r and omization , with 91 being assigned to escitalopram , 94 to tDCS , and 60 to placebo . In the intention‐to‐treat analysis , the mean ( ±SD ) decrease in the score from baseline was 11.3±6.5 points in the escitalopram group , 9.0±7.1 points in the tDCS group , and 5.8±7.9 points in the placebo group . The lower boundary of the confidence interval for the difference in the decrease for tDCS versus escitalopram ( difference , ‐2.3 points ; 95 % confidence interval [ CI ] , ‐4.3 to ‐0.4 ; P=0.69 ) was lower than the noninferiority margin of ‐2.75 ( 50 % of placebo minus escitalopram ) , so noninferiority could not be cl aim ed . Escitalopram and tDCS were both superior to placebo ( difference vs. placebo , 5.5 points [ 95 % CI , 3.1 to 7.8 ; P<0.001 ] and 3.2 points [ 95 % CI , 0.7 to 5.5 ; P=0.01 ] , respectively ) . Patients receiving tDCS had higher rates of skin redness , tinnitus , and nervousness than did those in the other two groups , and new‐onset mania developed in 2 patients in the tDCS group . Patients receiving escitalopram had more frequent sleepiness and obstipation than did those in the other two groups . CONCLUSIONS In a single‐center trial , tDCS for
Output:
| To conclude , tDCS seems to be safe and devoid of serious adverse effects , although robust efficacy has not been consistently demonstrated in clinical trials assessing an acute treatment course of up to 4 weeks . |
MS211448 | ***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 Many patients with chronic angina experience anginal episodes despite revascularization and antianginal medications . In a previous trial , antianginal monotherapy with ranolazine , a drug believed to partially inhibit fatty acid oxidation , increased treadmill exercise performance ; however , its long-term efficacy and safety have not been studied in combination with beta-blockers or calcium antagonists in a large patient population with severe chronic angina . OBJECTIVES To determine whether , at trough levels , ranolazine improves the total exercise time of patients who have symptoms of chronic angina and who experience angina and ischemia at low workloads despite taking st and ard doses of atenolol , amlodipine , or diltiazem and to determine times to angina onset and to electrocardiographic evidence of myocardial ischemia , effect on angina attacks and nitroglycerin use , and effect on long-term survival in an open-label observational study extension . DESIGN , SETTING , AND PATIENTS A r and omized , 3-group parallel , double-blind , placebo-controlled trial of 823 eligible adults with symptomatic chronic angina who were r and omly assigned to receive placebo or 1 of 2 doses of ranolazine . Patients treated at the 118 participating ambulatory outpatient setting s in several countries were enrolled in the Combination Assessment of Ranolazine In Stable Angina ( CARISA ) trial from July 1999 to August 2001 and followed up through October 31 , 2002 . INTERVENTION Patients received twice-daily placebo or 750 mg or 1000 mg of ranolazine . Treadmill exercise 12 hours ( trough ) and 4 hours ( peak ) after dosing was assessed after 2 , 6 ( trough only ) , and 12 weeks of treatment . MAIN OUTCOME MEASURES Change in exercise duration , time to onset of angina , time to onset of ischemia , nitroglycerin use , and number of angina attacks . RESULTS Trough exercise duration increased by 115.6 seconds from baseline in both ranolazine groups ( pooled ) vs 91.7 seconds in the placebo group ( P = .01 ) . The times to angina and to electrocardiographic ischemia also increased in the ranolazine groups , at peak more than at trough . The increases did not depend on changes in blood pressure , heart rate , or background antianginal therapy and persisted throughout 12 weeks . Ranolazine reduced angina attacks and nitroglycerin use by about 1 per week vs placebo ( P<.02 ) . Survival of 750 patients taking ranolazine during the CARISA trial or its associated long-term open-label study was 98.4 % in the first year and 95.9 % in the second year . CONCLUSION Twice-daily doses of ranolazine increased exercise capacity and provided additional antianginal relief to symptomatic patients with severe chronic angina taking st and ard doses of atenolol , amlodipine , or diltiazem , without evident adverse , long-term survival consequences over 1 to 2 years of therapy BACKGROUND Optimal treatment for patients with both type 2 diabetes mellitus and stable ischemic heart disease has not been established . METHODS We r and omly assigned 2368 patients with both type 2 diabetes and heart disease to undergo either prompt revascularization with intensive medical therapy or intensive medical therapy alone and to undergo either insulin-sensitization or insulin-provision therapy . Primary end points were the rate of death and a composite of death , myocardial infa rct ion , or stroke ( major cardiovascular events ) . R and omization was stratified according to the choice of percutaneous coronary intervention ( PCI ) or coronary-artery bypass grafting ( CABG ) as the more appropriate intervention . RESULTS At 5 years , rates of survival did not differ significantly between the revascularization group ( 88.3 % ) and the medical-therapy group ( 87.8 % , P=0.97 ) or between the insulin-sensitization group ( 88.2 % ) and the insulin-provision group ( 87.9 % , P=0.89 ) . The rates of freedom from major cardiovascular events also did not differ significantly among the groups : 77.2 % in the revascularization group and 75.9 % in the medical-treatment group ( P=0.70 ) and 77.7 % in the insulin-sensitization group and 75.4 % in the insulin-provision group ( P=0.13 ) . In the PCI stratum , there was no significant difference in primary end points between the revascularization group and the medical-therapy group . In the CABG stratum , the rate of major cardiovascular events was significantly lower in the revascularization group ( 22.4 % ) than in the medical-therapy group ( 30.5 % , P=0.01 ; P=0.002 for interaction between stratum and study group ) . Adverse events and serious adverse events were generally similar among the groups , although severe hypoglycemia was more frequent in the insulin-provision group ( 9.2 % ) than in the insulin-sensitization group ( 5.9 % , P=0.003 ) . CONCLUSIONS Overall , there was no significant difference in the rates of death and major cardiovascular events between patients undergoing prompt revascularization and those undergoing medical therapy or between strategies of insulin sensitization and insulin provision . ( Clinical Trials.gov number , NCT00006305 . OBJECTIVES The primary objective of the Monotherapy Assessment of Ranolazine In Stable Angina ( MARISA ) trial was to determine the dose-response relationship of ranolazine , a potentially new anti-anginal compound , on symptom-limited exercise duration . BACKGROUND Fatty acids rise precipitously in response to stress , including acute myocardial ischemia . Ranolazine is believed to partially inhibit fatty acid oxidation , shift metabolism toward carbohydrate oxidation , and increase the efficiency of oxygen use . METHODS Patients ( n = 191 ) with angina-limited exercise discontinued anti-anginal medications and were r and omized into a double-blind four-period crossover study of sustained-release ranolazine 500 , 1,000 , or 1,500 mg , or placebo , each administered twice daily for one week . Exercise testing was performed at the end of each treatment during both trough and peak ranolazine plasma concentrations . RESULTS Exercise duration at trough increased with ranolazine 500 , 1,000 , and 1,500 mg twice daily by 94 , 103 , and 116 s , respectively , all greater ( p < 0.005 ) than the 70-s increase on placebo . Dose-related increases in exercise duration at peak and in times to 1 mm ST-segment depression at trough and peak and to angina at trough and peak were also demonstrated ( all p < 0.005 ) . Ranolazine had negligible effects on heart rate and blood pressure . One year survival rate combining data from the MARISA trial and its open-label follow-on study was 96.3 + /- 1.7 % . CONCLUSIONS In chronic angina patients , ranolazine monotherapy was well tolerated and increased exercise performance throughout its dosing interval at all doses studied without clinical ly meaningful hemodynamic effects . One-year survival was not lower than expected in this high-risk patient population . This metabolic approach to treating myocardial ischemia may offer a new therapeutic option for chronic angina patients OBJECTIVES This study sought to determine whether initial medical therapy ( MT ) only or percutaneous coronary intervention plus medical therapy ( PCI+MT ) is better for patients with low-risk stable coronary artery disease ( CAD ) indicated for intervention in Japan . BACKGROUND Several multicenter studies have suggested that in the above patients , an initial management strategy of PCI+MT does not reduce the long-term risk of cardiovascular events more effectively than initial MT only . METHODS We conducted a r and omized comparative study ( JSAP [ Japanese Stable Angina Pectoris ] study ) in the previously mentioned patients . RESULTS The patients were r and omized to PCI+MT ( n = 192 ) or initial MT only group ( n = 192 ) , and the patient characteristics were very similar in the 2 groups . During the 3.3-year follow-up , there was no significant difference in the cumulative death rate between PCI+MT ( 2.9 % ) and MT ( 3.9 % ) . However , the cumulative risk of death plus acute coronary syndrome was significantly smaller in PCI+MT . CONCLUSIONS In stable low-risk CAD , PCI+MT may improve long-term prognosis more effectively than MT Background Detection of asymptomatic ischemia in patients with coronary artery disease has been associated with increased risk for adverse outcome , but treatment of patients with asymptomatic ischemia remains controversial . Accordingly , the purpose of this study was to determine if treatment reduces adverse outcome in patients with daily life ischemia . Methods and Results A multicenter , r and omized , double-blind , placebo- controlled study of asymptomatic or minimally symptomatic out patients with daily life silent ischemia due to coronary artery disease was conducted . The primary outcome measure was event- free survival at 1 year by Kaplan-Meier analysis . Events were death , resuscitated ventricular tachycardia/ fibrillation , myocardial infa rct ion , hospitalization for unstable angina , aggravation of angina , or revascularization . The secondary outcome was ischemia during ambulatory ECG monitoring at 4 weeks . Three hundred six out patients with mild or no angina ( Canadian Cardiovascular Society class I or II ) , abnormal exercise tests , and ischemia on ambulatory monitoring were r and omized to receive either atenolol ( 100 mg/d ) or placebo . After 4 weeks of treatment , the number ( mean±SD , 3.6±4.2 versus 1.7±4.6 episodes , P<.001 ) and average duration ( 30±3.3 versus 16.4 + 6.7 minutes , P<.001 ) of ischemic episodes per 48 hours of ambulatory monitoring decreased in atenolol- compared with placebo-assigned patients ( 4.4±4.6 to 3.1±6.0 episodes and 36.6±4.1 to 30±5.5 minutes ) . Event-free survival improved in atenolol-treated patients ( P<.0066 ) , who had an increased time to onset of first adverse event ( 120 versus 79 days ) and fewer total first events compared with placebo ( relative risk , 0.44 ; 95 % confidence intervals , 0.26 to 0.75 ; P=.001 ) . There was a nonsignificant trend for fewer serious events ( death , resuscitation from ventricular tachycardia/fibrillation , nonfatal myocardial infa rct ion , or hospitalization for unstable angina ) in atenolol-treated patients ( relative risk , 0.55 ; 95 % confidence intervals , 0.22 to 1.33 ; P=.175 ) . The most powerful univariate and multivariate correlate of event-free survival was absence of ischemia on ambulatory monitoring at 4 weeks . Side effects were mild and generally similar comparing atenolol- and placebo-treated patients , although bradycardia was more frequent with atenolol . Conclusions Atenolol treatment reduced daily life ischemia and was associated with reduced risk for adverse outcome in asymptomatic and mildly symptomatic patients compared with placebo Background —Percutaneous transluminal coronary angioplasty of the infa rct -related artery in stable survivors of acute myocardial infa rct ion is often performed , even in patients without any symptoms or residual ischemia . Despite the lack of r and omized studies , it is widely believed that this intervention will improve the clinical outcome of these patients . Methods and Results —Three hundred patients with single vessel disease of the infa rct vessel and no or minor angina pectoris in the subacute phase ( 1 to 6 weeks ) after an acute myocardial infa rct ion were r and omized to angioplasty ( n=149 ) or medical therapy ( n=151 ) . Primary end point was the survival free of reinfa rct ion , (re)intervention , coronary artery bypass surgery , or readmission for severe angina pectoris at 1 year . The event-free survival at 1 year was 82 % in the medical group and 90 % in the angioplasty group ( P = 0.06 ) . This difference was mainly driven by the difference in the need for ( re ) interventions ( 20 versus 8 , P = 0.03 ) . At long-term follow-up ( mean , 56 months ) , survival was 89 % and 96 % ( P = 0.02 ) . Survival free of reinfa rct ion , (re)intervention , or coronary artery bypass surgery was 66 % and 80 % in the medically and interventionally treated patients , respectively ( P = 0.05 ) . The use of nitrates was significantly lower in the angioplasty group , both at 1 year ( 38 % versus 67 % , P = 0.001 ) and at long-term follow-up ( 36 % versus 55 % , P = 0.006 ) . Conclusions —Percutaneous revascularization of the infa rct -related coronary artery in stable patients with single vessel disease improves clinical outcome at long-term follow-up and reduces
Output:
| The most commonly used antianginal agents ( beta-blockers , nitrates , calcium channel blockers , and ranolazine ) demonstrated equivalent efficacy in improving patient reported ischemic symptoms and quantitative exercise parameters .
With regards to mortality , beta-blockers are beneficial in the setting of depressed left ventricular systolic function .
In contrast , recent evidence points toward the lack of similar benefit of beta-blockers in patients with preserved systolic function , even in the setting of prior myocardial infa rct ion .
No survival benefit has been identified with the use of calcium channel blockers , nitrates , or ranolazine . |
MS211449 | ***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 Testicular sperm extraction ( TESE ) is an effective procedure to retrieve sperm from some men with nonobstructive azoospermia ( NOA ) . To optimize treatment effectiveness , we have review ed our experience with TESE for NOA to better underst and technical factors needed for sperm retrieval and lead to an optimized approach to TESE . METHODS Eighty-one men with confirmed NOA underwent attempted TESE using an open technique under optical magnification . Each testis sample was dispersed and examined in the operating room . Sequential biopsy attempts were made until sperm were visualized or until further biopsies were thought to jeopardize testicular blood flow . In 20 patients , st and ard biopsy and initial mechanical dispersion of the seminiferous tubules were compared with the passage of tissue through a 24-gauge angiocatheter after initial dispersion to quantitate spermatozoal yield . RESULTS Overall , 47 ( 58 % ) of 81 patients who underwent TESE had direct intraoperative visualization of spermatozoa . The average number of biopsy attempts for all patients was 8.9 and for patients with sperm isolated 6.4 ( P = 0.002 ) . Passage of the testicular tissue suspension through a 24-gauge angiocatheter increased sperm retrieval in matched tissue specimens from 83,000 to 390,000 or 470 % over that achieved with st and ard dispersion alone ( P = 0.005 ) . An initial , substantive tissue biopsy revealed sperm in only 23 ( 28 % ) of 81 patients . Using this approach with sequential biopsies under optical magnification , no patient had evidence of testis injury or devascularization . CONCLUSIONS Because multiple TESE procedures can cause transient and permanent alterations in testicular function , it is imperative to perform TESE as safely and as efficiently as possible . We suggest that open TESE with optical magnification provides a safe method of retrieving sperm . A single biopsy for extraction is inadequate to detect spermatozoa for men with NOA . Use of the needle dispersion technique with passage of testicular tissue through an angiocatheter enhances detection of sperm and could potentially reduce the need for subsequent biopsies . An algorithm to minimize biopsies and allow sperm retrieval is presented Testicular sperm extraction ( TESE ) may provide spermatozoa for attempts at fertility with assisted reproduction ; however , the physiological effects of TESE on testicular function are not well understood . In order to evaluate the effects of TESE on the testis , 64 patients were evaluated after TESE for non-obstructive azoospermia with physical examinations , serial scrotal sonography , histological analyses and evaluation of the success of repeated sperm retrieval attempts . At 3 months after TESE , 82 % of evaluated patients had ultrasonographic abnormalities in the testis suggesting resolving inflammation or haematoma at the biopsy site . By 6 months , these acute inflammatory changes typically resolved leaving linear scars or calcifications . Two patients had documented impaired testicular blood flow , with complete devascularization of the testis for one patient after TESE with multiple biopsies . Repeat TESE procedures were far more likely to retrieve spermatozoa if the second TESE attempt was performed > 6 months after the initial TESE procedure ( 80 % ) , relative to those performed within 6 months ( 25 % ) . Transient adverse physiological effects are common in the testis for up to 6 months after TESE . In addition , permanent devascularization of the testis can occur following TESE procedures with multiple biopsies . The risk of this complication may be minimized by using an open biopsy technique with optical magnification to directly identify testicular vessels OBJECTIVE To evaluate the outcomes of microdissection testicular sperm extraction ( micro-TESE ) in patients with high FSH . DESIGN Clinical retrospective study . SETTING Department of urology at a tertiary university hospital . PATIENT(S ) Seven hundred ninety-two men with nonobstructive azoospermia . INTERVENTION(S ) Micro-TESE followed by intracytoplasmic sperm injection was performed . The men were classified into four groups based on serum FSH levels : < 15 , 15 - 30 , 31 - 45 , and > 45 IU/mL. MAIN OUTCOME MEASURE(S ) Sperm retrieval , clinical pregnancy , and live birth rates . RESULT ( S ) Testicular sperm were successfully retrieved in 60 % of the men . Sperm retrieval rates in the groups of men with FSH values 15 - 30 , 31 - 45 , and > 45 IU/mL was 60 % , 67 % , and 60 % respectively ; this was higher than the group of men with FSH < 15 ( 51 % ) . Of those men who had sperm retrieved , clinical pregnancy and live birth rates were similar in the four groups ( 46 % , 50 % , 52 % , 46 % and 38 % , 45 % , 44 % , 36 % , respectively ) . CONCLUSION ( S ) The chances of sperm retrieval using micro-TESE is just as common , if not better for men with elevated FSH levels than for men with lower FSH . Micro-TESE results appear to differ from earlier series that report low retrieval rates with r and om biopsies for men with elevated FSH . High FSH is not a contraindication for micro-TESE In a population of non-obstructive azoospermia patients , the efficacy of microsurgical testicular sperm extraction ( microTESE ) and conventional TESE was evaluated in a r and omized controlled study on 138 testicles , classified and paired in a 48-square table according to the different classes of the following three variables : patient plasma FSH concentration , orchidometry and testicular histology . Sperm retrieval was positive in 21/22 testicles with hypospermatogenesis ( 11/11 , 10/11 ; microTESE , TESE respectively ) , in 12/14 with maturation arrest ( 6/7 , 6/7 ) , in 16/22 with incomplete Sertoli cell-only syndrome ( 8/11 , 8/11 ) , and in 16/80 with complete Sertoli cell-only syndrome ( 11/40 , 5/40 ) . Sperm recovery was positive in 5/24 patients with FSH concentration > or = 3 x maximum value of normal range ( N ) ( 4/12 , 1/12 ) , in 17/40 patients with 2N < or = FSH < 3N ( 9/20 , 8/20 ) , in 30/48 patients with N < FSH < 2N ( 17/24 , 13/24 ) , and in 13/26 patients with FSH = N ( 6/13 , 7/13 ) . Regarding orchidometry , sperm recovery was positive in 11/18 testicles with volume ( V ) > or = 12 ml ( 6/9 , 5/9 ) , in 27/56 testicles with 8 ml < or = V < 12 ml ( 15/28 , 12/28 ) , and in 27/64 testicles with V < 8 ml ( 15/32 , 12/32 ) . FSH value and the surgical procedure were the two variables significantly ( P < 0.05 ) predicting positive sperm retrieval OBJECTIVE To perform conventional and microdissection testicular sperm extraction ( TESE ) at the same session and compare their effectiveness . DESIGN Prospect i ve comparative study . SETTING University hospital setting . PATIENT(S ) The study included 335 patients with nonobstructive azoospermia . INTERVENTION(S ) Microdissection TESE was performed to 77 patient with atrophic testes . An additional 258 patients underwent conventional TESE using three incisions on three quadrants of the testis ( upper , middle , and lower ) . Microdissection TESE was performed by enlarging the middle incision vertically when no spermatozoa could be detected using the conventional technique . MAIN OUTCOME MEASURE(S ) Sperm retrieval , fertilization , clinical pregnancy rate ( PR ) , and live birth rate were evaluated . The relation between sperm retrieval rate and FSH level and testis volume was also investigated . RESULT ( S ) Spermatozoa was detected in 33.7 % of patients using conventional TESE . The spermatozoa detected increased to 50.8 % using microdissection TESE . The increase was statistically significant . In the primary microdissection TESE group , the surgical retrieval rate was 20.8 % . The overall sperm retrieval rate was 43.9 % . There was a significant relation between the sperm retrieval rate and testis volume , whereas there was no relation between sperm retrieval rate and FSH levels . The overall fertilization rate , clinical PR , and live birth rate were 57.1 % , 50.4 % , 36.4 % , respectively . CONCLUSION ( S ) Conventional TESE combined with microdissection TESE can be used in selected patients . Sperm retrieval rate of TESE can be low in patients with atrophic testes The value of testicular sperm extraction ( TESE ) by microdissection was evaluated according to its physiological consequences compared with open , classic surgical biopsy in the same patient . A total of 100 patients with non-obstructive azoospermia and bilateral identical testicular histology underwent bilateral diagnostic TESE via the conventional method on one side and the microsurgical method on the other side . The spermatozoa recovery rate by microdissection TESE was significantly higher than by conventional TESE ( 47 and 30 % respectively ; P < 0.05 ) . In order to assess the safety of this new procedure , 60 patients were followed-up ultrasonographically for 1 , 3 and 6 months . Acute and chronic complications were significantly lower in the microsurgical side compared with the conventional side ( 15 and 58.3 % respectively and 3 and 30 % respectively ; P < 0.05 ) . Segmental devascularization was detected in seven testes operated on conventionally , and in two testes operated on microsurgically . However , permanent devascularization could not be detected in any patient after 6 months . These findings suggest that microdissection TESE is not devoid of complications , but that it is relatively safer than the conventional technique and improves sperm yield significantly in patients with non-obstructive azoospermia
Output:
| Fewer complications were observed on ultrasound examination after microTESE procedure .
Pseudo-r and omized prospect i ve data , however , show more favourable sperm retrieval in NOA for microTESE , especially in histological patterns of patchy spermatogenesis such as Sertoli cell only syndrome .
However , in patients with uniform histological patterns such as maturation arrest outcome of microTESE seems less favourable |
MS211450 | ***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 In non-small-cell lung cancer ( NSCLC ) , clinical and biologic predictors for epidermal growth factor receptor ( EGFR ) tyrosine kinase inhibitor sensitivity have been identified in retrospective studies , and there is urgent need to vali date these results in prospect i ve trials . The ONCOBELL trial is a prospect i ve phase II study evaluating gefitinib sensitivity in NSCLC patients who never smoked or have increased EGFR gene copy number or activation of the antiapoptotic protein Akt . PATIENTS AND METHODS EGFR gene copy number was evaluated using fluorescence in situ hybridization ( FISH ) , and presence of phospho-Akt was evaluated using immunohistochemistry . Additional tests included immunohistochemistry analysis of EGFR , FISH analysis of HER2 , and mutation analysis of EGFR , HER2 , and K-ras . RESULTS From November 2004 to February 2006 , 183 patients were screened , and 42 patients were enrolled onto the trial . We observed one complete and 19 partial responses , for an overall response rate ( RR ) of 47.6 % ( 95 % CI , 32.5 % to 62.7 % ) . Median duration of response was 6.1 months , median time to progression ( TTP ) was 6.4 months , 1-year survival rate was 64.3 % , and median survival time was not reached . EGFR FISH-positive patients , compared with negative patients , had higher RR ( 68.0 % v 9.1 % , respectively ; P < .001 ) , longer TTP ( 7.6 v 2.7 months , respectively ; P = .02 ) , and a trend for longer survival ( median survival not reached v 7.4 months , respectively ; P = .3 ) . Therapy was well tolerated , and there were no drug-related deaths . Median follow-up time was too short for significance tests of differences in survival outcomes . CONCLUSION Gefitinib is active and well tolerated in patients with trial characteristics , and EGFR FISH analysis is an accurate predictor for such therapy PURPOSE To evaluate the efficacy and tolerability of two doses of gefitinib ( Iressa [ ZD1839 ] ; AstraZeneca , Wilmington , DE ) , a novel epidermal growth factor receptor tyrosine kinase inhibitor , in patients with pretreated advanced non-small-cell lung cancer ( NSCLC ) . PATIENTS AND METHODS This was a r and omized , double-blind , parallel-group , multicenter phase II trial . Two hundred ten patients with advanced NSCLC who were previously treated with one or two chemotherapy regimens ( at least one containing platinum ) were r and omly assigned to receive either 250-mg or 500-mg oral doses of gefitinib once daily . RESULTS Efficacy was similar for the 250- and 500-mg/d groups . Objective tumor response rates were 18.4 % ( 95 % confidence interval [ CI ] , 11.5 to 27.3 ) and 19.0 % ( 95 % CI , 12.1 to 27.9 ) ; among evaluable patients , symptom improvement rates were 40.3 % ( 95 % CI , 28.5 to 53.0 ) and 37.0 % ( 95 % CI , 26.0 to 49.1 ) ; median progression-free survival times were 2.7 and 2.8 months ; and median overall survival times were 7.6 and 8.0 months , respectively . Symptom improvements were recorded for 69.2 % ( 250 mg/d ) and 85.7 % ( 500 mg/d ) of patients with a tumor response . Adverse events ( AEs ) at both dose levels were generally mild ( grade 1 or 2 ) and consisted mainly of skin reactions and diarrhea . Drug-related toxicities were more frequent in the higher-dose group . Withdrawal due to drug-related AEs was 1.9 % and 9.4 % for patients receiving gefitinib 250 and 500 mg/d , respectively . CONCLUSION Gefitinib showed clinical ly meaningful antitumor activity and provided symptom relief as second- and third-line treatment in these patients . At 250 mg/d , gefitinib had a favorable AE profile . Gefitinib 250 mg/d is an important , novel treatment option for patients with pretreated advanced NSCLC [ corrected 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 Introduction : Relationships between clinical outcomes and epidermal growth factor receptor (EGFR)-related tumor markers were investigated in patients with advanced non-small cell lung cancer . Methods : Patients with stage IIIB/IV non-small cell lung cancer ( 0–2 prior regimens ) received erlotinib ( 150 mg PO per day ) . Response and survival were evaluated , and tumor sample s were assessed by immunohistochemistry ( EGFR , phosphorylated mitogen-activated protein kinase , and phosphorylated AKT protein expression ) , fluorescence in situ hybridization ( FISH ; EGFR gene copy number ) , and DNA sequencing ( EGFR , KRAS gene mutations ) . Results : Among 311 patients , 8 % had a complete/partial response ; the disease control rate was 66 % . Median Overall survival ( OS ) was 6.1 months ; 1-year survival rate was 27.2 % . Two of 4 patients with EGFR mutations had tumor responses , versus 2/68 with wild-type EGFR ( p = 0.014 ) . Progression-free survival ( PFS ) ( HR = 0.31 ) and OS ( HR = 0.33 ) were significantly prolonged in patients with EGFR mutations . Response rate was significantly higher in patients with EGFR FISH-positive ( 17 % ) than FISH-negative tumors ( 6 % ) , and both PFS ( HR = 0.58 ) and OS ( HR = 0.63 ) significantly favored patients with EGFR FISH-positive tumors ; median OS was 8.6 months in the EGFR FISH-positive group . None of 17 patients with a KRAS mutation had a tumor response , but the impact of KRAS mutation status on survival outcomes was of borderline statistical significance . Neither phosphorylated mitogen-activated protein kinase nor phosphorylated AKT immunohistochemistry status had a significant effect on PFS and OS with erlotinib . Conclusions : The presence of EGFR mutations and EGFR FISH-positive tumors may predispose patients to achieving better outcomes on erlotinib , but may have a beneficial impact on prognosis ( irrespective of treatment ) . Prospect i ve , placebo-controlled studies are needed to determine the predictive value of the putative biomarkers Purpose : To examine potential markers of clinical benefit and the effects of erlotinib on the epidermal growth factor receptor ( EGFR ) signaling pathway in advanced non – small cell lung cancer patients refractory to platinum-based chemotherapy . Experimental Design : Patients were given erlotinib ( 150 mg/d ) . Tumor biopsies were done immediately before treatment and in a subgroup of patients after 6 weeks ' treatment . Results : Of 73 evaluable patients , 7 ( 10 % ) had partial response and 28 ( 38 % ) had stable disease . In 53 patients with baseline tumor sample s , no relationship was observed between pretreatment levels of EGFR , phosphorylated (p)-EGFR , p-AKT , p-mitogen-activated protein kinase ( MAPK ) , or p27 and clinical benefit ( i.e. , response , or stable disease ≥12 weeks ) . Tumors from 15 of 57 patients had high EGFR gene copy number , assessed using fluorescence in situ hybridization ( FISH positive ) , 10 of whom had clinical benefit , compared with 5 of 42 FISH-negative patients . FISH-positive patients had longer median progression-free [ 137 versus 43 days , P = 0.002 ; hazard ratio ( HR ) , 0.37 ] and overall ( 226 versus 106 days , P = 0.267 ; HR , 0.70 ) survival than FISH-negative patients . In paired biopsy sample s from 14 patients , p-EGFR ( P = 0.002 ) , p-MAPK ( P = 0.001 ) , and Ki-67 ( P = 0.025 ) levels were significantly reduced after 6 weeks ' treatment . Apoptosis was significantly increased in patients with clinical benefit ( P = 0.029 ) , and may be a marker of clinical benefit . Conclusion : In this study , EGFR FISH-positive status was associated with improved outcome after erlotinib therapy . Erlotinib led to reduced levels of p-EGFR , p-MAPK , and Ki-67 , and stimulated apoptosis in tumor sample s from patients with clinical benefit A number of different clinical characteristics and molecular markers related to epidermal growth factor receptor ( EGFR ) activation have been reported to singly correlate with therapeutic activity of EGFR tyrosine kinase inhibitors ( TKIs ) in advanced non-small cell lung cancer ( NSCLC ) . This study was design ed to evaluate the predictive value on gefitinib outcomes of a comprehensive panel of molecular parameters in advanced NSCLC patients . EGFR and K-ras mutations were detected by direct sequencing on tumor DNA from paraffin embedded sample s. EGFR and HER2 gene copy number was assessed by FISH . EGFR protein expression was quantified by immunohistochemistry . EGFR gene intron 1 polymorphism was assessed on genomic DNA isolated from venous whole blood sample s. Ninety-one patients were prospect ively enrolled and the overall gefitinib response rate was 18.7 % ( 2 complete and 15 partial responses ) . Sex ( p=0.005 ) , non-smoking status ( p=0.010 ) , skin toxicity ( p=0.020 ) , EGFR gene mutations ( p<0.001 ) and EGFR FISH positivity ( p=0.016 ) were found to be associated with gefitinib response . K-ras mutation was detected in only seven non-responder patients . The median overall survival was of 10 months . Only non-smoking status and EGFR intron 1 polymorphism showed a statistically significant correlation with survival ( p=0.031 and 0.044 , respectively ) . In conclusion , we have confirmed the role of EGFR gene mutation as predictor of response to EGFR TKIs . Moreover , EGFR gene copy number and , potentially , also EGFR intron 1 polymorphism could aid in better prediction of EGFR TKI responsiveness in advanced NSCLC PURPOSE Erlotinib is a highly specific epidermal growth factor receptor ( HER1/EGFR ) tyrosine kinase inhibitor . This phase II study of erlotinib in patients with HER1/EGFR-expressing non-small-cell lung cancer previously treated with platinum-based chemotherapy evaluated tumor response , survival , and symptom improvement . PATIENTS AND METHODS Fifty-seven patients received an oral , continuous daily dose of 150 mg of erlotinib . Assessment s of objective response used WHO and Response Evaluation Criteria in Solid Tumors criteria . The European Organization for Research and Treatment of Cancer Quality of Life Question naire C30 , supplemented with a lung cancer module , Quality of Life Question naire LC13 , was used to measure health-related quality of life . Additional analyses were performed to identify predictors of response and survival . RESULTS The objective response
Output:
| The result of the analysis found that EGFR gene copy number was associated with increased OS and PFS , supporting the idea that EGFR gene copy number is a biomarker for response to EGFR-TKI therapy in patients with advanced NSCLC |
MS211451 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Abstract Objective : To 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 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 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 The effects of the electronic display of guideline -based , patient-specific treatment suggestions on pharmacist work patterns were studied . A total of 28 pharmacists at a hospital-based ambulatory care pharmacy were r and omly assigned to intervention and control groups . The intervention group had access to electronic treatment suggestions for heart failure , ischemic heart disease , reactive airways disease , and uncomplicated hypertension , while the control group did not . Starting 9 and 19 months after the initial display of treatment suggestions , all pharmacists recorded the time they spent on a variety of activities , the purpose of each activity , and persons contacted during the activity ; these observations were recorded in response to a pager-like device that r and omly buzzed four times an hour . A total of 11,102 observations were recorded . Pharmacists in the intervention group spent significantly more of their time discussing information , advising and informing , and solving problems than pharmacists in the control group but significantly less of their time checking and filling prescriptions . Pharmacists in both groups completed a majority of their work alone , but pharmacists in the intervention group worked significantly less by themselves and significantly more with other pharmacy personnel , patients , and physicians and nurses than control-group pharmacists . The delivery of patient-specific information to pharmacists at the time of dispensing had a significant positive impact on pharmacist work patterns OBJECTIVE A research prototype Physician Workstation ( PWS ) incorporating a graphical user interface and a drug ordering module was compared with the existing hospital information system in an academic Veterans Administration General Medical Clinic . Physicians in the intervention group received recommendations for drug substitutions to reduce costs and were alerted to potential drug interactions . The objective was to evaluate the effect of the PWS on user satisfaction , on health-related outcomes , and on costs . DESIGN A one-year , two-period , r and omized controlled trial with 37 subjects . MEASUREMENTS Differences in the reliance on noncomputer sources of information , in user satisfaction , in the cost of prescribed medications , and in the rate of clinical ly relevant drug interactions were assessed . RESULTS The study subjects logged onto the workstation an average of 6.53 times per provider and used it to generate 2.8 % of prescriptions during the intervention period . On a five-point scale ( 5 = very satisfied , 1 = very dissatisfied ) , user satisfaction declined in the PWS group ( 3.44 to 2.98 p = 0.008 ) , and increased in the control group ( 3.23 to 3.72 , p < 0.0001 ) . CONCLUSION The intervention physicians did not use the PWS frequently enough to influence information-seeking behavior , health outcomes , or cost . The study design did not determine whether the poor usage result ed from satisfaction with the control system , problems using the PWS intervention , or the functions provided by the PWS intervention . Evaluative studies should include provisions to improve the chance of successful implementation as well as to yield maximum information if a negative study occurs OBJECTIVE To evaluate whether an electronic reminder integrated into a routine computer system increases the use of antiplatelet drugs for diabetic patients among Italian general practitioners ( GPs ) . RESEARCH DESIGN AND METHODS A r and omized controlled trial was carried out among 300 GPs and their patients selected from the Health Search Data base . Among these , 150 GPs ( intervention group ) received instructions to activate an electronic reminder plus a letter summarizing the beneficial effects of antiplatelet drugs in diabetic patients with at least one additional cardiovascular risk factor ( " high risk " ) , whereas the other 150 GPs ( control group ) received only the letter . The electronic reminder , integrated into a st and ard software system for the management of the daily clinical practice , was displayed when every participating GP opened the medical record of diabetic patients aged > or = 30 years . Only high-risk diabetic patients were included in the analysis . Patients were considered under antiplatelet treatment if they received two or more prescriptions at baseline and during the follow-up . RESULTS We selected 15,343 high-risk diabetic patients , 7,313 belonging to GPs of the control group and 8,030 belonging to GPs of the intervention group . Overall , 1,672 patients ( 22.9 % ) of the control group and 1,886 ( 23.5 % ) patients of the intervention group received antiplatelet drugs at baseline ( P = N.S. ) . At the end of the follow-up , the number of treated patients was significantly increased in the intervention group ( odds ratio 1.99 , 95 % CI 1.79 - 2.22 ) versus the control group . The effect of the electronic reminder was more relevant among those patients with one or more cardiovascular risk factors but without previous cardiovascular diseases ( CVDs ) , compared with those with CVDs . CONCLUSIONS These findings provide evidence for the effect of an electronic reminder in affecting the prescriptive behavior of GPs BACKGROUND Although they are effective in outpatient setting s , computerized reminders have not been proved to increase preventive care in inpatient setting s. METHODS We conducted a r and omized , controlled trial to determine the effects of computerized reminders on the rates at which four preventive therapies were ordered for in patients . During an 18-month study period , a computerized system processed on-line information for all 6371 patients admitted to a general-medicine service ( for a total of 10,065 hospitalizations ) , generating preventive care reminders as appropriate . Physicians who were in the intervention group viewed these reminders when they were using a computerized order-entry system for in patients . RESULTS The reminder system identified 3416 patients ( 53.6 percent ) as eligible for preventive measures that had not been ordered by the admitting physician . For patients with at least one indication , computerized reminders result ed in higher adjusted ordering rates for pneumococcal vaccination ( 35.8 percent of the patients in the intervention group vs. 0.8 percent of those in the control group , P<0.001 ) , influenza vaccination ( 51.4 percent vs. 1.0 percent , P < 0.001 ) , prophylactic heparin ( 32.2 percent vs. 18.9 percent , P<0.001 ) , and prophylactic aspirin at discharge ( 36.4 percent vs. 27.6 percent , P<0.001 ) . CONCLUSIONS A majority of hospitalized patients in this study were eligible for preventive measures , and computerized reminders significantly increased the rate of delivery of such therapies CONTEXT The impact of clinical decision support systems ( CDSS ) on antimicrobial prescribing in ambulatory setting s has not previously been evaluated . OBJECTIVE To measure the added value of CDSS when coupled with a community intervention to reduce inappropriate prescribing of antimicrobial drugs for acute respiratory tract infections . DESIGN , PARTICIPANTS AND SETTING Cluster r and omized trial that included 407,460 inhabitants and 334 primary care clinicians in 12 rural communities in Utah and Idaho ( 6 with 1 shared characteristic and 6 with another ) , and a third group of 6 communities that served as non study controls . The preintervention period was January to December 2001 and the postintervention period was January 2002 to September 2003 . Acute respiratory tract infection diagnoses were classified into groups based on indication for antimicrobial use . Multilevel regression methods were applied to account for the clustered design . INTERVENTION Six communities received a community intervention alone and 6 communities received community intervention plus CDSS that were targeted toward primary care clinicians . The CDSS comprised decision support tools on paper and a h and held computer to guide diagnosis and management of acute respiratory tract infection . MAIN OUTCOME MEASURE Community-wide antimicrobial usage was assessed using retail pharmacy data . Diagnosis-specific antimicrobial use was compared by chart review . RESULTS Within CDSS communities , 71 % of primary care clinicians participated in the use of CDSS . The prescribing rate decreased from 84.1 to 75.3 per 100 person-years in the CDSS arm vs 84.3 to 85.2 in community intervention alone , and remained stable in the other communities ( P = .03 ) . A total of 13,081 acute respiratory tract infection visits were abstract ed . The relative decrease in antimicrobial prescribing for visits in the antibiotics " never-indicated " category during the post-intervention period was 32 % in CDSS communities and 5 % in community intervention-alone communities ( P = .03 ) . Use of macrolides decreased significantly in CDSS communities but not in community intervention-alone communities . CONCLUSION CDSS implemented in rural primary care setting s reduced overall antimicrobial use and improved
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| Descriptive analysis did not confirm any feature to be more prevalent in successful trials relative to unsuccessful ones for implementation , provider behaviour or patient outcomes .
Conclusion While RxCDSSs have the potential to change health care provider behaviour , very few high quality studies show improvement in patient outcomes .
Furthermore , the features of the RxCDSS associated with success ( or failure ) are poorly described , thus making it difficult for system design and implementation to improve |
MS211452 | ***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: We report the results of a phase II trial in patients with metastatic endocrine tumours from different sites , which aim ed to evaluate the anti-tumour activity and toxicity of a cisplatinum and etoposide regimen administered in combination with the somatostatin agonist lanreotide given in slow release formulation . Between January 1999 and November 2003 , 27 patients with histological diagnoses of endocrine tumours with different degrees of differentiation , excluding well differentiated carcinoid neoplasms , received intravenous ( i.v . ) administration of cisplatinum ( 30 mg m−2 ) and etoposide ( 100 mg m−2 ) on days 1–3 and intramuscular administration of 60 mg lanreotide on day 1 , in a 21-day cycle . All of the patients were evaluable for toxicity and response . The treatment was very well tolerated as no grade 4 toxicity was observed . Four patients achieved a complete response , six a partial response , 12 experienced disease stabilisation and five disease progression . The average time to progression and to survival were 9 and 24 months respectively . These results suggest that this chemo-hormone therapy regimen is well tolerated and active in patients with non-well differentiated endocrine tumours Purpose Pasireotide ( SOM230 ) , a novel multireceptor lig and somatostatin analog ( SSA ) , binds with high affinity to four of the five somatostatin receptor subtypes ( sst1–3 , 5 ) . This study evaluated the safety , tolerability , pharmacokinetics , and pharmacodynamics profiles of pasireotide long-acting release ( LAR ) formulation in patients with advanced gastroenteropancreatic neuroendocrine tumor ( GEP NET ) refractory to other SSAs . Methods In this r and omized , multicenter , open-label , phase II study , patients with biopsy-proven primary or metastatic GEP NET refractory to available SSAs were r and omly assigned 1:1:1 to receive pasireotide LAR by deep intragluteal injection at a dose of 20 , 40 , or 60 mg once every 28 days for 3 months . Results Forty-two patients received pasireotide LAR . Adverse events were reported by 34 ( 81 % ) patients , with the most frequently reported including diarrhea , fatigue , abdominal pain , and nausea . Mean fasting glucose levels were increased compared with baseline at all points throughout the study . After the third injection of pasireotide LAR , the median trough plasma concentrations on day 84 were 4.82 , 12.0 , and 19.7 ng/mL in the 20- , 40- , and 60-mg treatment groups , respectively . Drug accumulation was limited for each dose based on the increase in trough concentrations after the first to third injections ( accumulation ratios were approximately 1 from all dose levels ) . Conclusions This study demonstrated that a new , once-monthly , intramuscular LAR formulation of pasireotide was well tolerated in patients with advanced GEP NET . Steady state levels of plasma pasireotide were achieved after three injections Background Somatostatin analogues ( SSAs ) are indicated to relieve carcinoid syndrome but seem to have antiproliferative effects on neuroendocrine tumours ( NETs ) . This is the first prospect i ve study investigating tumour stabilisation with the long-acting SSA lanreotide Autogel in patients with progressive NETs . Methods This was a multicentre , open-label , phase II trial conducted in 17 Spanish specialist centres . Patients with well-differentiated NETs and radiologically confirmed progression within the previous 6 months received lanreotide Autogel , 120 mg every 28 days over ≤92 weeks . The primary endpoint was progression-free survival ( PFS ) . Secondary endpoints were response rate , tumour biomarkers , symptom control , quality of life ( QoL ) , and safety . Radiographic imaging was assessed by a blinded central radiologist . Results Of 30 patients included in the efficacy and safety analyses , 40 % had midgut tumours and 27 % pancreatic tumours ; 63 % of tumours were functioning . Median PFS time was 12.9 ( 95 % CI : 7.9 , 16.5 ) months , and most patients achieved disease stabilisation ( 89 % ) or partial response ( 4 % ) . No deterioration in QoL was observed . Nineteen patients ( 63 % ) experienced treatment-related adverse events , most frequently diarrhoea and asthenia ; only one treatment-related adverse event ( aerophagia ) was severe . Conclusion Lanreotide Autogel provided effective tumour stabilisation and PFS > 12 months in patients with progressive NETs ineligible for surgery or chemotherapy , with a safety profile consistent with the pharmacology of the class . Trial registration Clinical Trials.gov Identifier NCT00326469 ; EU Clinical Trial Register EudraCT no 2004 - 002871 - 18 PURPOSE Effective systemic therapy for advanced carcinoid is lacking . The combination of bevacizumab ( BEV ) and pegylated ( PEG ) interferon alpha-2b was evaluated among patients with metastatic or unresectable carcinoid tumors . PATIENTS AND METHODS Forty-four patients on stable doses of octreotide were r and omly assigned to 18 weeks of treatment with bevacizumab or PEG interferon alpha-2b . At disease progression ( PD ) or at the end of 18 weeks ( whichever occurred earlier ) , patients received bevacizumab plus PEG interferon until progression . Functional computer tomography ( CT ) scans were performed to measure effect on tumor blood flow . RESULTS In the bevacizumab arm , four patients ( 18 % ) achieved confirmed partial response ( PR ) , 17 patients ( 77 % ) had stable disease ( SD ) , and one patient ( 5 % ) had PD . In the PEG interferon arm , 15 patients ( 68 % ) had SD and six patients ( 27 % ) had PD . Progression-free survival ( PFS ) rates after 18 weeks of monotherapy were 95 % in bevacizumab versus 68 % on the PEG interferon arm . The overall median PFS for all 44 patients is 63 weeks . Compared with paired baseline measurements on functional CT scans , we observed a 49 % ( P < .01 ) and 28 % ( P < .01 ) decrease in tumor blood flow at day 2 and week 18 among patients treated with bevacizumab . No significant changes in tumor blood flow were observed following PEG interferon . PEG interferon alpha-2b treatment was associated with decrease in plasma basic fibroblast growth factor ( bFGF ; P = .04 ) and increase in plasma interleukin-18 ( IL-18 ; P < .01 ) . No significant changes in bFGF or IL-18 following treatment with bevacizumab were observed . CONCLUSION Bevacizumab therapy result ed in objective responses , reduction of tumor blood flow , and longer PFS in patients with carcinoid than PEG interferon treatment We investigated the relationship between the results of the octreotide test and somatostatin receptor ( SSTR ) 2 expression in insulinoma patients , to evaluate the usefulness of this test for predicting SSTR2 expression in insulinomas in Japanese patients . Five females and one male were included in the study . All patients underwent the octreotide test before the surgery carried out to resect the tumor , and histopathological examination of the resected tumor was performed by a single experienced pathologist . SSTR2 expression was evaluated by the SSTR2 immunohistochemistry scoring system . Insulinoma was clinical ly diagnosed and surgically resected in all six patients . In the octreotide test , suppression of insulin secretion was sufficient after loading in patients 1 - 4 and 6 . In patient 5 , however , the suppression of insulin secretion was insufficient , which result ed in severe hypoglycemia with endogenous relative hyperinsulinemia after the octreotide loading . The histopathological findings revealed SSTR2 expression in the insulinomas of patients 1 - 4 and 6 , but not in the insulinoma of patient 5 . In conclusion , improvement of hyperinsulinemic hypoglycemia by octreotide in Japanese insulinoma patients was associated with SSTR2 expression in the tumor . Our results suggest that the octreotide test could be useful for predicting SSTR2 expression in the tumor In the CLARINET study , lanreotide Autogel ( depot in USA ) significantly prolonged progression-free survival ( PFS ) in patients with metastatic pancreatic/intestinal neuroendocrine tumours ( NETs ) . We report long-term safety and additional efficacy data from the open-label extension ( OLE ) . Patients with metastatic grade 1/2 ( Ki-67 ≤10 % ) non-functioning NET and documented baseline tumour-progression status received lanreotide Autogel 120 mg ( n=101 ) or placebo ( n=103 ) for 96 weeks or until death/progressive disease ( PD ) in CLARINET study . Patients with stable disease ( SD ) at core study end ( lanreotide/placebo ) or PD ( placebo only ) continued or switched to lanreotide in the OLE . In total , 88 patients ( previously : lanreotide , n=41 ; placebo , n=47 ) participated : 38 % had pancreatic , 39 % midgut and 23 % other/unknown primary tumours . Patients continuing lanreotide reported fewer adverse events ( AEs ) ( all and treatment-related ) during OLE than core study . Placebo-to-lanreotide switch patients reported similar AE rates in OLE and core studies , except more diarrhoea was considered treatment-related in OLE ( overall diarrhoea unchanged ) . Median lanreotide PFS ( core study r and omisation to PD in core/OLE ; n=101 ) was 32.8 months ( 95 % CI : 30.9 , 68.0 ) . A sensitivity analysis , addressing potential selection bias by assuming that patients with SD on lanreotide in the core study and not entering the OLE ( n=13 ) had PD 24 weeks after last core assessment , found median PFS remaining consistent : 30.8 months ( 95 % CI : 30.0 , 31.3 ) . Median time to further PD after placebo-to-lanreotide switch ( n=32 ) was 14.0 months ( 10.1 ; not reached ) . This OLE study suggests long-term treatment with lanreotide Autogel 120 mg maintained favourable safety/tolerability . CLARINET OLE data also provide new evidence of lanreotide anti-tumour benefits in indolent and progressive pancreatic/intestinal NETs OBJECTIVE High-dose somatostatin analogue treatment has shown an antiproliferative effect in one study including patients with neuroendocrine tumours . To explore this therapeutic strategy further , we have studied the effect of a high-dose formula of octreotide , octreotide pamoate , in midgut carcinoid patients . DESIGN AND METHODS Twelve patients with advanced midgut carcinoid tumours with a median duration of disease of more than 5 years were included . All were in a progressive state despite several previous treatment modalities . Octreotide pamoate ( 160 mg ) was given as an intramuscular injection every 2 weeks for 2 months and then monthly . Radiological and biochemical responses were monitored . RESULTS Tumour size and biochemical markers were stabilised for a median of 12 months in 75 % of the patients . Ten patients had symptomatic improvement of flush and diarrhoea . CONCLUSION In this group of patients with advanced midgut carcinoid tumours and progressive disease , octreotide pamoate managed to improve symptoms , and stabilise hormone production and tumour growth in 75 % of the patients . We believe that high-dose treatment with somatostatin analogues can be an important addition to the therapeutic arsenal for patients with advanced progressive midgut carcinoid tumours BACKGROUND : Somatostatin analogues effectively control flushing and diarrhoea in patients with the carcinoid syndrome . The octapeptide lanreotide is available in slow release form , which could eliminate the necessity of twice a day injections as with octreotide . PATIENTS AND METHODS : 39 patients with carcinoid syndrome were included in a prospect i ve multicentre study . Patients received lanreotide 30 mg intramuscularly every 14 days for six months . The number and intensity of flushing episodes and bowel movements , urinary 5 hydroxy-indolacetic acid ( 5 HIAA ) concentrations , and variations of tumour mass were recorded . RESULTS : After one month of treatment , flushing episodes ( median ( range ) ) decreased significantly ( 3 ( 0.3 - 24 ) episodes per day v 1 ( 0 - 15 ) , p = 0.04 ) and completely resolved in 39 % of the patients . A significant decrease was seen in the number of bowel movements and discomfort related to diarrhoea . Urinary 5 HIAA concentrations were unchanged in 57 % of the patients and decreased in 18 % . After six months of treatment , the actuarial proportions of patients with at least a 50 % decrease in the number of flushing episodes and bowel movements were 54 % and 56 % , respectively . Forty two per cent of the patients who were treated for six months had at
Output:
| Conclusion In this appraisal , we have found some practical aspects that can help to the optimization of somatostatin analog ( SSA ) therapy in patients with well-differentiated GEP-NETs . |
MS211453 | ***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: This study was design ed to investigate the impact of the Entropy Module ® and Bispectral Index ® ( BIS ) monitoring on drug consumption and recovery times compared with st and ard anaesthetic practice in patients undergoing orthopaedic surgery using a combination of regional and general anaesthesia as performed by an experienced anaesthesiologist . We hypothesised that electroencephalogram monitoring would lead to a lower drug consumption as well as shorter recovery times . With institutional review board approval and written informed consent , 90 adult patients undergoing surgery to the upper or lower extremity received regional anaesthesia for post- and intraoperative pain control and were r and omised to receive general anaesthesia by propofol/remifentanil infusion controlled either solely by clinical parameters or by targeting Entropy or BIS values of 50 . Recovery times and drug consumption were recorded . Data from 79 patients were analysed . Compared with st and ard practice , patients with Entropy or BIS monitoring showed a similar propofol consumption ( st and ard practice 101±22 μg/kg/minute , Entropy 106±24 μg/kg/minute , BIS 104±20 μg/kg/minute ) and showed similar Aldrete scores ( 10/10 ) one minute after extubation : 9.1∓0.3 , 9.2±0.6 and 9.3±0.5 , respectively . Time points of extubation were 7.3±2.9 minutes , 9.2∓3.9 minutes and 6.8±2.9 minutes , respectively , demonstrating a significant difference between Entropy and BIS ( P=0.023 ) . Compared with st and ard practice , targeting an Entropy or BIS value of 50 did not result in a reduction of propofol consumption during general anaesthesia combined with regional anaesthesia as performed by an experienced anaesthesiologist in orthopaedic patients This study was performed to investigate the quality of different intravenous sedation techniques , and the correlation between the Bispectral Index ( BIS ) values and the Observer 's Assessment of Alertness/Sedation ( OAA/S ) scores . Eighty patients undergoing sinonasal surgery were r and omly assigned to one of four groups . Group MF received midazolam and fentanyl , group PF received propofol and fentanyl , group MR received midazolam and remifentanil , and group PR received propofol and remifentanil . Heart rate and mean arterial pressuure values were not different among the groups . SpO 2 decreased only after intravenous medication in groups MF and MR ( P<0.017 ) . Emesis was less common with propofol . A positive relationship existed between the BIS values and OAA/S scores during the operation in all groups and the strongest correlation was observed in group PR ( r=0.565 and P<0.001 ) . In conclusion , these four intravenous sedation techniques did not change mean arterial pressure , heart rate or SpO 2 clinical ly and produced a similar level of light sedation . The BIS was useful for monitoring of sedation during sinonasal surgery under local anaesthesia with intravenous sedation BACKGROUND Awareness is an uncommon complication of anaesthesia , affecting 0.1 - 0.2 % of all surgical patients . Bispectral index ( BIS ) monitoring measures the depth of anaesthesia and facilitates anaesthetic titration . In this trial we determined whether BIS-guided anaesthesia reduced the incidence of awareness during surgery in adults . METHODS We did a prospect i ve , r and omised , double-blind , multicentre trial . Adult patients at high risk of awareness were r and omly allocated to BIS-guided anaesthesia or routine care . Patients were assessed by a blinded observer for awareness at 2 - 6 h , 24 - 36 h , and 30 days after surgery . An independent committee , blinded to group identity , assessed every report of awareness . The primary outcome measure was confirmed awareness under anaesthesia at any time . FINDINGS Of 2463 eligible and consenting patients , 1225 were assigned to the BIS group and 1238 to the routine care group . There were two reports of awareness in the BIS-guided group and 11 reports in the routine care group ( p=0.022 ) . BIS-guided anaesthesia reduced the risk of awareness by 82 % ( 95 % CI 17 - 98 % ) . INTERPRETATION BIS-guided anaesthesia reduces the risk of awareness in at-risk adult surgical patients undergoing relaxant general anaesthesia . With a cost of routine BIS monitoring at US16 dollars per use in Australia and a number needed to treat of 138 , the cost of preventing one case of awareness in high-risk patients is about 2200 dollars BACKGROUND We compared the propofol requirements and recovery times when either the bispectral index ( BIS ) monitor or the cerebral state monitor ( CSM ) is used to guide propofol anaesthesia . METHODS Forty patients undergoing laparoscopic cholecystectomy were studied . All patients were monitored with both monitors and were r and omly allocated into two groups according to the monitor used to titrate propofol administration . Propofol was administered to maintain BIS or CSM within 40 and 60 . Propofol consumption and clinical markers of recovery were assessed after surgery . RESULTS In the CSM group , the values of cerebral state index ( CSI ) and BIS were 47 ( 5 ) and 38 ( 6 ) , respectively ( P=0.00054 ) . In the BIS group , the values of CSI and BIS were 47 ( 5 ) and 45 ( 2 ) , respectively ( P=0.15 ) . In the BIS group , the total amount of propofol used was lower [ 109 ( 20 ) microg kg(-1 ) min(-1 ) ] than in the CSM group [ 130 ( 27 ) microg kg(-1 ) min(-1 ) ] ( P=0.018 ) . The time to eye opening was lower in the BIS [ 7.2 ( 3.5 ) min ] than in the CSM group [ 10.7 ( 6.6 ) ] ( P=0.038 ) . There were no differences in fentanyl consumption , or in other clinical markers of recovery . CONCLUSIONS Compared with BIS , propofol anaesthesia guided with CSI result ed in 20 % higher propofol doses . This , however , does not lead to clinical ly relevant differences in recovery times Purpose This study was design ed to investigate the effect of bispectral index ( BIS ) monitoring on the recovery profiles , level of postoperative cognitive dysfunction , and anesthetic drug requirements of elderly patients undergoing elective orthopedic surgery with general anesthesia . Methods Sixty-eight patients over the age of 60 were r and omized into one of two groups . In the st and ard practice ( SP ) group , the anesthesiologists were blinded to the BIS value , and isoflurane was titrated according to st and ard clinical practice . In the BIS group , isoflurane was titrated to maintain a BIS value between 50–60 . Results The total isoflurane usage was 30 % lower in the BIS group compared to the SP group ( 5.6 ± 3 vs 7.7 ± 3 mL , P < 0.05 ) . The time to orientation was faster in the BIS group compared to the SP group ( 9.5 ± 3vs 13.1 ± 4 min , P < 0.001 ) . There were no differences in the postoperative psychometric tests between the two groups . Conclusions There was no difference in the level of postoperative cognitive dysfunction between the two groups . However , titration of isoflurane using the BIS index decreased utilization of isoflurane and contributed to faster emergence of elderly patients undergoing elective knee or hip replacement surgery . RésuméObjectifRechercher l’effet du monitorage par l’index bispectral ( BIS ) sur les profils de récupération , le niveau de déficit cognitif postopératoire et les besoins d’anesthésiques chez des patients âgés qui subissent une intervention orthopédique non urgente avec anesthésie générale . MéthodeSoixante-huit patients de plus de 60 ans ont été répartis au hasard en deux groupes . Pour ceux du groupe de pratique courante ( PC ) , la valeur du BIS n’était pas connue des anesthésiologistes et l’isoflurane a été titré selon les normes de la pratique clinique . Pour les patients du groupe BIS , l’isoflurane a été titré de façon à maintenir un BIS entre 50 et 60.RésultatsL’utilisation totale d’isoflurane a été plus basse de 30 % dans le groupe BIS , comparé au groupe PC ( 5,6 ± 3 vs 7,7 ± 3 mL , P < 0,05 ) . Le retour à la conscience a été plus rapide dans le groupe BIS , comparé au groupe PC ( 9,5 ± 3 vs 13,1 ±4 min , P < 0,001 ) . Les tests psychométriques postopératoires n’ont présenté aucune différence intergroupe . Conclusion Le niveau de déficit cognitif postopératoire n’était pas différent d’un groupe à l’autre . Cependant , le titrage de l’isoflurane à l’aide de l’index BIS a permis de réduire l’utilisation d’isoflurane et a favorisé une récupération plus rapide chez des patients âgés qui subissent la mise en place d’une prothèse totale de hanche Background : Intraoperative awareness with explicit recall occurs in approximately 0.15 % of all surgical cases . Efficacy trials based on the Bispectral Index ® ( BIS ) monitor ( Covidien , Boulder , CO ) and anesthetic concentrations have focused on high-risk patients , but there are no effectiveness data applicable to an unselected surgical population . Methods : We conducted a r and omized controlled trial of unselected surgical patients at three hospitals of a tertiary academic medical center . Surgical cases were r and omized to alerting algorithms based on either BIS values or anesthetic concentrations . The primary outcome was the incidence of definite intraoperative awareness ; prespecified secondary outcomes included postanesthetic recovery variables . Results : The study was terminated because of futility . At interim analysis the incidence of definite awareness was 0.12 % ( 11/9,376 ) ( 95 % CI : 0.07–0.21 % ) in the anesthetic concentration group and 0.08 % ( 8/9,460 ) ( 95 % CI : 0.04–0.16 % ) in the BIS group ( P = 0.48 ) . There was no significant difference between the two groups in terms of meeting criteria for recovery room discharge or incidence of nausea and vomiting . By post hoc secondary analysis , the BIS protocol was associated with a 4.7-fold reduction in definite or possible awareness events compared with a cohort receiving no intervention ( P = 0.001 ; 95 % CI : 1.7–13.1 ) . Conclusion : This negative trial could not detect a difference in the incidence of definite awareness or recovery variables between monitoring protocol s based on either BIS values or anesthetic concentration . By post hoc analysis , a protocol based on BIS monitoring reduced the incidence of definite or possible intraoperative awareness compared with routine care Background : Bispectral Index (BIS)–titrated administration allows a reduction of propofol infusion rates in patients undergoing surgery . Result ing differences in anesthetic depth might affect the stress response to surgery involving neural circuitry not reflected in the electroencephalogram . Methods : Forty patients scheduled to undergo elective coronary artery bypass grafting receiving a background infusion of remifentanil ( 0.3 & mgr;g · kg−1 · min−1 ) were anesthetized with intravenous propofol delivered by target-controlled infusion according to the Marsh pharmacokinetic model under BIS monitoring . In a r and omized , prospect i ve design , 20 patients received propofol at a target concentration of 3 & mgr;g/ml , whereas in 20 patients propofol was titrated to maintain a BIS value of 40–50 . Plasma concentrations of propofol ( by means of gas chromatography – mass spectrometry ) , epinephrine , norepinephrine ( by means of high-pressure liquid chromatography ) , cortisol ( by means of radioimmunoassay ) , and interleukins 6 and 10 ( by means of enzyme-linked immunosorbent assay ) were measured repeatedly throughout surgery . Results : BIS monitoring allowed a 30 % reduction of propofol infusion rates and a similar decrease in plasma propofol concentrations in the BIS group without affecting the stress response to surgery for the group mean . None of the patients reported awareness during a st and ardized interview . Interestingly , propofol – remifentanil anesthesia blunted the release of epinephrine and cortisol to bypass surgery completely even when the propofol infusion rate was reduced according to BIS values . Conclusions : Total intravenous anesthesia using propofol – remifentanil effectively attenuates the neurohumoral stress response to coronary bypass surgery involving cardiopulmonary bypass . Titration of propofol using BIS allows for significant reduction of propofol consumption , with only minor effects on stress response under these conditions BACKGROUND Awareness is a serious complication of general anesthes
Output:
| RESULTS The use of monitoring with the bispectral index has shown benefits reducing time to extubation , orientation in time and place , and discharge from both the operating room and post anesthetic care unit .
Clinical ly , anesthesia monitoring with the BIS can be justified because it allows advantages from reducing the recovery time after waking , mainly by reducing the administration of general anesthetics as well as the risk of adverse events |
MS211454 | ***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 Green tea polyphenols ( GTPs ) have significant antioxidant and antiinflammatory activities , and prior short‐term studies suggest that these compounds may improve photoaging skin . OBJECTIVES To evaluate the long‐term effects of oral GTPs on the clinical and histologic characteristics of photoaging skin . MATERIAL S AND METHODS Double‐blind , placebo‐controlled trial of 56 women aged 25 to 75 r and omized to 250 mg GTPs or placebo twice daily for 2 years . A blinded dermatologist scored the appearance of photodamaged facial skin at 0 , 6 , 12 , and 24 months . A blinded dermatopathologist scored the histologic characteristics of sun‐exposed arm skin at 0 and 24 months . RESULTS Clinical assessment of facial skin revealed that the GTP group had significant improvement in overall solar damage at 6 months ( p=.02 ) and significant improvement in erythema and telangiectasias at 12 months ( p=.02 ) . The placebo group did not have significant improvements in these parameters at 6 months or 12 months . There were no statistically significant differences in other photoaging parameters at 6 , 12 , or 24 months in the GTP or placebo groups . Histopathologic analysis of sunexposed arm skin showed no statistically significant difference in photoaging parameters in the GTP group or the placebo group at 24 months . CONCLUSIONS Long‐term supplementation with oral GTPs was not superior to placebo in improving clinical or histologic photoaging parameters after 24 months of use . Funding and material s for this study were provided by Nu Skin , Provo , Utah . Dale Kern is an employee of Nu Skin International Background Raisins are a significant source of dietary fiber and polyphenols , which may reduce cardiovascular disease ( CVD ) risk by affecting lipoprotein metabolism and inflammation . Walking represents a low intensity exercise intervention that may also reduce CVD risk . The purpose of this study was to determine the effects of consuming raisins , increasing steps walked , or a combination of these interventions on blood pressure , plasma lipids , glucose , insulin and inflammatory cytokines . Results Thirty-four men and postmenopausal women were matched for weight and gender and r and omly assigned to consume 1 cup raisins/d ( RAISIN ) , increase the amount of steps walked/d ( WALK ) or a combination of both interventions ( RAISINS + WALK ) . The subjects completed a 2 wk run-in period , followed by a 6 wk intervention . Systolic blood pressure was reduced for all subjects ( P = 0.008 ) . Plasma total cholesterol was decreased by 9.4 % for all subjects ( P < 0.005 ) , which was explained by a 13.7 % reduction in plasma LDL cholesterol ( LDL-C ) ( P < 0.001 ) . Plasma triglycerides ( TG ) concentrations were decreased by 19.5 % for WALK ( P < 0.05 for group effect ) . Plasma TNF-α was decreased from 3.5 ng/L to 2.1 ng/L for RAISIN ( P < 0.025 for time and group × time effect ) . All subjects had a reduction in plasma sICAM-1 ( P < 0.01 ) . Conclusion This research shows that simple lifestyle modifications such as adding raisins to the diet or increasing steps walked have distinct beneficial effects on CVD risk Epidemiologic studies indicated that tea consumption reduces the risk of cardiovascular disease . We assessed the effect of green or black tea consumption on resistance of low-density lipoprotein ( LDL ) to oxidation ex vivo and on serum lipid concentrations in healthy volunteers . In a 4-wk parallel comparison trial , 45 volunteers consumed 900 mL ( 6 cups ) mineral water , green tea , or black tea/d . Blood sample s drawn while subjects were fasting were obtained before and after the study . The effect on resistance of subsequently isolated LDL to oxidation of adding green or black tea extract to plasma was investigated in an in vitro experiment . Consumption of 900 mL ( 6 cups ) green or black tea/d did not affect serum lipid concentrations , resistance of LDL to oxidation , or markers of oxidative damage to lipids in vivo , although consumption of green tea slightly increased total antioxidant activity of plasma . The in vitro experiment showed that resistance of isolated LDL to oxidation increased only after incubation of plasma with very high amounts of green or black tea . These amounts , when converted to tea catechin concentrations , were much higher than those expected in vivo . We conclude that daily consumption of 900 mL ( 6 cups ) green or black tea/d for 4 wk had no effect on serum lipid concentrations or resistance of LDL to oxidation ex vivo . Future research should focus on mechanisms by which tea flavonoids may reduce the risk of cardiovascular disease other than by increasing the intrinsic antioxidant status of LDL BACKGROUND Patients treated with hemodialysis frequently experience cardiovascular complications attributed , among other causes , to dyslipidemia , increased oxidative stress , and inflammation . OBJECTIVE The aim of the study was to study the effects of dietary supplementation with concentrated red grape juice ( RGJ ) , a source of polyphenols , on lipoprotein profile , antioxidant capacity , LDL oxidation , and inflammatory biomarkers . DESIGN Twenty-six patients receiving hemodialysis and 15 healthy subjects were instructed to drink 100 mL RGJ/d for 14 d. Blood was drawn at baseline , twice during RGJ supplementation , and twice during the 6-mo follow-up period . As a control , 12 other r and omly recruited hemodialysis patients not receiving RGJ were studied . Lipids , apolipoproteins , oxidized LDL , and antioxidant vitamins were measured in plasma . The bioavailability of RGJ polyphenols was assessed in healthy subjects . RESULTS The maximum plasma concentration of quercetin was achieved 3 h after RGJ ingestion , which indicates that supplement-derived polyphenols are rapidly absorbed . In both healthy subjects and hemodialysis patients , RGJ consumption increased the antioxidant capacity of plasma without affecting concentrations of uric acid or ascorbic acid ; reduced the concentration of oxidized LDL ; and increased the concentration of cholesterol-st and ardized alpha-tocopherol . RGJ supplementation also caused a significant decrease in LDL-cholesterol and apolipoprotein B-100 concentrations , while increasing the concentrations of HDL cholesterol and apolipoprotein A-I. In a further study in hemodialysis patients , RGJ supplementation for 3 wk significantly reduced plasma monocyte chemoattractant protein 1 , an inflammatory biomarker associated with cardiovascular disease risk . CONCLUSION Dietary supplementation with concentrated RGJ improves the lipoprotein profile , reduces plasma concentrations of inflammatory biomarkers and oxidized LDL , and may favor a reduction in cardiovascular disease risk BACKGROUND Oxidative damage to lipids in vivo may be involved in the development of atherosclerosis and cancer . Onions and black tea are foods rich in flavonoids , predominantly the flavonoid quercetin , which is a potent in vitro inhibitor of membrane lipid peroxidation and LDL oxidation . OBJECTIVE Our objective was to investigate the effects of consuming a high-flavonoid ( HF ) diet enriched with onions and black tea on indexes of oxidative damage in vivo compared with a low-flavonoid ( LF ) diet . DESIGN Thirty-two healthy humans were studied in a r and omized crossover design . Indexes of oxidative damage used were plasma F2-isoprostanes ( a biomarker of lipid peroxidation in vivo ) and the titer of antibodies to malondialdehyde (MDA)-modified LDL . RESULTS There were no significant differences in the intake of macronutrients or assessed micronutrients , plasma F2-isoprostane concentrations , and MDA-LDL autoantibody titer between the HF and LF dietary treatments . In the men , however , plasma concentrations of the F2-isoprostane 8-epi-prostagl and in F2alpha were slightly higher after the HF treatment phase than after the LF treatment [ 0.31 + /- 0.029 nmol/L ( 111 + /- 10.4 ng/L ) compared with 0.26 + /- 0.022 nmol/L ( 92 + /- 7.8 ng/L ) ; P = 0.041 ] . In all subjects , plasma quercetin concentrations were significantly higher after the HF treatment phase than after the LF treatment : 221.6 + /- 37.4 nmol/L compared with less than the limit of detection of 66.2 nmol/L. CONCLUSION Flavonoid consumption in onions and tea had no significant effect on plasma F2-isoprostane concentrations and MDA-LDL autoantibody titer in this study and thus does not seem to inhibit lipid peroxidation in humans BACKGROUND Tea has been associated with a reduced risk of cardiovascular disease . One proposed mechanism of this risk reduction involves inhibition of lipoprotein oxidation in vivo by antioxidant polyphenolic compounds derived from tea . However , controlled interventions uniformly failed to show that ingestion of tea can inhibit LDL oxidation ex vivo . The absence of effects in previous studies may be due to the isolation of LDL particles from polyphenolic compounds that are present in the aqueous phase of serum . OBJECTIVE The objective of this study was to examine the acute effects of ingestion of black and green tea on ex vivo Cu(2+)-induced lipoprotein oxidation without prior isolation of lipoproteins from serum . DESIGN The acute effects of 4 hot drinks-green tea and black tea ( each at a dose equivalent to 4 st and ard cups ) , water matched to the teas for caffeine content , and water-were assessed in 20 healthy men by using a Latin-square design . The lag time to lipoprotein diene formation , slope of the propagation phase of the oxidation curve , and area under the oxidation curve were calculated . Urinary concentrations of 4-O-methylgallic acid were used as a marker of uptake and metabolism of polyphenolic compounds from tea . RESULTS Significant increases in urinary 4-O-methylgallic acid for black and green tea ( P < 0 . 0001 ) were observed . Caffeine did not significantly influence lipoprotein oxidation . Compared with the water control , there was a greater lag time for black tea ( 5.4 + /- 2.9 min ; P = 0.05 ) that was of borderline significance and a similar trend for green tea ( 4.4 + /- 2.8 min ; P = 0.17 ) . Slope and area under the oxidation curve were not altered . CONCLUSION Black tea has a mild acute effect on ex vivo lipoprotein oxidation in human serum . 2000;71:-7 Prospect i ve studies suggest that tea may protect against cardiovascular disease . A potential mechanism for such an effect involves inhibition of lipid peroxidation by polyphenolic antioxidants derived from tea . Our objective was to determine whether regular ingestion of tea could inhibit in vivo lipid peroxidation . Two controlled intervention studies assessed the effects of regular ingestion of tea on lipid peroxidation determined by measurement of urinary F(2)-isoprostane excretion . Study 1 : The effects of 1000 mL/d of green tea and black tea were compared with hot water containing caffeine in 13 subjects with elevated blood pressure using a r and omized 3-period ( 7 d each ) crossover design . Study 2 : The effects of 1250 mL/d of black tea were compared with hot water in 22 subjects with mildly raised serum total cholesterol concentrations using a r and omized 2-period ( 4 wk each ) crossover design . F(2)-isoprostane excretion was not altered after regular ingestion of green tea ( 273 + /- 48 pmol/mmol creatinine ) or black tea ( 274 + /- 39 pmol/mmol creatinine ) in comparison with hot water ( 263 + /- 47 pmol/mmol creatinine ; Study 1 ) , or by regular ingestion of black tea ( 334 + /- 71 pmol/mmol creatinine ) in comparison with hot water ( 355 + /- 75 pmol/mmol creatinine ; Study 2 ) . These results do not support the suggestion that polyphenolic antioxidants derived from tea inhibit in vivo lipid peroxidation To evaluate the effects of grape polyphenols on plasma lipids , inflammatory cytokines , and oxidative stress , 24 pre- and 20 postmenopausal women were r and omly assigned to consume 36 g of a lyophilized grape powder ( LGP ) or a placebo for 4 wk . The LGP consisted of 92 % carbohydrate and was rich in flavans , anthocyanins , quercetin , myricetin , kaempferol , and resveratrol . After a 3-wk washout period , subjects were assigned to the alternate treatment for an additional 4 wk . The placebo consisted of an equal ratio of fructose and dextrose and was similar in
Output:
| Vitis vinifera L. showed promising results , but other trials should be performed in order to assessing the efficacy .
No studies were found on the leaves of Olea europea L. whereas more human trials are needed to assess the anti-inflammatory effect of olive oil . |
MS211455 | ***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 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 Abstract Pre clinical studies of chemoprevention drugs given in combination at low doses show remarkable efficacy in preventing adenomas with little additional toxicities , suggesting a strategy to improve risk to benefit ratios for preventing recurrent adenomas . Three hundred seventy-five patients with history of resected ( ≥3 mm ) adenomas were r and omly assigned to receive oral difluoromethylornithine ( DFMO ) 500 mg and sulindac 150 mg once daily or matched placebos for 36 months , stratified by use of low-dose aspirin ( 81 mg ) at baseline and clinical site . Follow-up colonoscopy was done 3 years after r and omization or off- study . Colorectal adenoma recurrence was compared among the groups with log-binomial regression . Comparing the outcome in patients receiving placebos to those receiving active intervention , ( a ) the recurrence of one or more adenomas was 41.1 % and 12.3 % ( risk ratio , 0.30 ; 95 % confidence interval , 0.18 - 0.49 ; P < 0.001 ) ; ( b ) 8.5 % had one or more advanced adenomas , compared with 0.7 % of patients ( risk ratio , 0.085 ; 95 % confidence interval , 0.011 - 0.65 ; P < 0.001 ) ; and ( c ) 17 ( 13.2 % ) patients had multiple adenomas ( > 1 ) at the final colonoscopy , compared with 1 ( 0.7 % ; risk ratio , 0.055 ; 0.0074 - 0.41 ; P < 0.001 ) . Serious adverse events ( grade ≥3 ) occurred in 8.2 % of patients in the placebo group , compared with 11 % in the active intervention group ( P = 0.35 ) . There was no significant difference in the proportion of patients reporting hearing changes from baseline . Recurrent adenomatous polyps can be markedly reduced by a combination of low oral doses of DFMO and sulindac and with few side effects 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 & NA ; Reports of RCTs of analgesics frequently describe results of studies in the form of mean derived indices , rather than using discontinuous events — such as number or proportion of patients with 50 % pain relief . Because mean data inadequately describe information with a non‐normal distribution , combining mean data in systematic review s may compromise the results . Showing that dichotomous data can reliably be derived from mean data , at least in acute pain models , indicates that more meaningful overviews or meta‐ analysis may be possible . This study investigated the relationship between continuous and dichotomous analgesic measures in a set of individual patient data , and then used that relationship to derive dichotomous from continuous information in r and omised controlled trials ( RCTs ) of analgesics . Individual patient information from 13 RCTs of parallel‐group and crossover design in acute postoperative pain was used to calculate the percentage of the maximum possible pain relief score ( % maxTOTPAR ) and the proportion of patients with greater than 50 % pain relief ( > 50%maxTOTPAR ) for the different treatments . The relationship between the measures was investigated in 45 actual treatments and 10 000 treatments simulated using the underlying actual distribution ; 1283 patients had 45 separate treatments . Mean % maxTOTPAR correlated with the proportion of patients with > 50%maxTOTPAR ( r2 = 0.90 ) . The relationship calculated from all the 45 treatments predicted to within three patients the number of patients with more than 50 % pain relief in 42 of 45 treatments , and 98.8 % of 10 000 simulated treatments . For seven effective treatments , actual numbers‐needed‐to‐treat ( NNT ) to achieve > 50%maxTOTPAR compared with placebo were very similar to those derived from calculated data OBJECTIVE The purpose of this study was to establish whether nimesulide causes fewer fetal side effects than indomethacin or sulindac after short-term maternal exposure for tocolysis . STUDY DESIGN This was a double-blind , double-dummy prospect i ve r and omized study with three drug treatment groups ( n = 10 per group ) that were comprised of subjects who were at 28 to 32 weeks of gestation with preterm contractions . The subjects were treated in the delivery suites of two busy inner-city teaching hospitals ; the intervention consisted of 48 hours of treatment and with 72 hours of follow-up observation with indomethacin 100 mg ( twice daily ) , sulindac 200 mg ( twice daily ) , or nimesulide 200 mg ( twice daily ) . The amniotic fluid index , hourly fetal urine production , and ductal Doppler pulsatility index observations were monitored before the treatment and at 4 , 24 , 48 , 72 , and 120 hours after the treatment was started . The statistical analysis used repeated measures analysis of variance , Bonferroni test , and Bl and -Altman agreement . Significance assumed when the probability value was < .05 . RESULTS Each drug caused a significant reduction in all three observations over the 48-hour treatment period , which recovered to pretreatment levels by 72 hours after treatment . There were no significant differences among drugs for any of these effects . CONCLUSION Nimesulide causes similar short-term fetal side effects to indomethacin and sulindac ABSTRACT Objective : To evaluate the effects of long-term treatment with sulindac on the progression of diabetic retinopathy ( DR ) . Research design and methods : 40 Japanese patients with type 2 diabetes were enrolled in a r and omized , single-blind controlled trial in which the effects of sulindac ( 200 mg/day , 100 mg twice a day ; n = 16 patients ) on the progression of DR were compared to controls ( 24 patients ) for 3 years . All patients were comparable in their age , gender , duration of disease , body mass index , dipstick proteinuria , insulin therapy , glycemic control , and clinical stages of DR . Outcome was determined by comparing parameters of retinopathy in fundus photographs that were taken at time 0 to those taken 1 , 2 , and 3 years after the initiation of treatment . Results : Patients in the sulindac group did not develop DR during the course of treatment nor was there progression of pathology in those who began the study with mild non-proliferative DR ( NPDR ) . On the other h and , six patients progressed to mild NPDR in the control group – three at year 1 and three at year 3 – and an additional patient progressed to severe NPDR from mild NPDR by year 1 and to proliferative DR by year 2 . The findings at year 3 in the sulindac group were significantly ( p < 0.05 ) different from the control group . None of the patients experienced any adverse effects of treatment . Conclusions : Long-term treatment with sulindac was clinical ly effective in decreasing the progression of mild DR in type 2 diabetic patients in this pilot study & NA ; A data base of r and omised clinical trials ( RCTs ) in pain research published from 1950 to 1990 was created following an extensive literature search . By applying a refined MEDLINE search strategy from 1966 to 1990 and by h and ‐ search ing more than 1 000 000 pages of a total of 40 biomedical journals published during the period 1950–1990 , more than 8000 RCTs were identified . The RCTs were published in more than 800 journals and over 85 % appeared between 1976 and 1990 . If the trend of the last 15 years persists , a total of more than 15 000 RCTs will be published in pain relief by the year 2000 . A detailed description of methods to ensure efficient use of re sources during the identification , retrieval and management of the information in pain relief and other fields is given . Emphasis is made on the importance of refining MEDLINE search strategies , on the use of volunteers to h and ‐ search journals and on careful monitoring of each of the steps of the process . The potential uses of the data base to guide clinical and research decisions are discussed Abstract One way to ensure adequate sensitivity for analgesic trials is to test the intervention on patients who have established pain of moderate to severe intensity . The usual criterion is at least moderate pain on a categorical pain intensity scale . When visual analogue scales ( VAS ) are the only pain measure in trials we need to know what point on a VAS represents moderate pain , so that these trials can be included in meta‐ analysis when baseline pain of at least moderate intensity is an inclusion criterion . To investigate this we used individual patient data from 1080 patients from r and omised controlled trials of various analgesics . Baseline pain was measured using a 4‐point categorical pain intensity scale and a pain intensity VAS under identical conditions . The distribution of the VAS scores was examined for 736 patients reporting moderate pain and for 344 reporting severe pain . The VAS scores corresponding to moderate or severe pain were also examined by gender . Baseline VAS scores recorded by patients reporting moderate pain were significantly different from those of patients reporting severe pain . Of the patients reporting moderate pain 85 % scored over 30 mm on the corresponding VAS , with a mean score of 49 mm . For those reporting severe pain 85 % scored over 54 mm with a mean score of 75 mm . There was no difference between the corresponding VAS scores of men and women . Our results indicate that if a patient records a baseline VAS score in excess of 30 mm they would probably have recorded at least moderate pain on a 4‐point categorical scale The elderly ( age > 65 years ) are more vulnerable to side-effects induced by non-steroidal anti-inflammatory drugs ( NSAIDs ) . We therefore performed a double-blind comparative study of ketoprofen SR and sulindac in patients with active rheumatoid arthritis , 65 years of age or older . Sulindac was chosen because of its possible renal sparing effects , and ketoprofen SR because of its short half life and sustained release delivery system . Eighty patients were entered . More patients withdrew from the study due to side-effects in the sulindac group ; both treatment groups had a high incidence of side-effects during this study and during previous exposure to other NSAIDs , demonstrating that the elderly are susceptible to side-effects from NSAID
Output:
| AUTHORS ' CONCLUSIONS In the absence of evidence of efficacy , at present , for oral sulindac in acute postoperative pain , its use in this indication is not justified . |
MS211456 | ***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 Despite studies that show improvements in both st and ards of care and outcomes with the judicious application of clinical practice guidelines ( CPGs ) , their clinical utilization remains low . This r and omized controlled trial examined the use of a wirelessly networked mobile computer ( MC ) by physicians at the bedside with access to an emergency department information system , decision support tools ( DSTs ) , and other software options . METHODS Each of ten volunteer emergency physicians was r and omized using a matched-pair design to work five shifts in st and ard fashion ( desktop computer [ DC ] access ) and five shifts with a wirelessly networked MC . Work pattern issues and electronic CPG/DST use were compared using end-of-shift satisfaction question naires and review of a CPG/DST data base . Repeated- measures analysis of variance was used to examine between-shift differences . RESULTS A total of 100 eight-hour shifts were evaluated ; 99 % compliance with postshift question naires was achieved . Using a seven-point Likert scale ( MC values first ) , MCs were rated as being as fast ( 5.04 vs. 4.54 ; p=0.13 ) and convenient ( 5.08 vs. 4.14 ; p=0.07 ) as DCs . Overall , physicians rated MCs to be less efficient ( 3.18 vs. 4.30 ; p=0.02 ) but encouraged more frequent use of DSTs ( 4.10 vs. 3.47 ; p=0.03 ) without impacting doctor-patient communication ( 2.78 vs. 2.96 ; p=0.51 ) . During the study period , physician use of an intranet Web application ( eCPG ) was more frequent during shifts assigned to the MC when compared with the DC ( eCPG uses/shift , 3.6 vs. 2.0 ; p=0.033 ) . CONCLUSIONS The MC technology permitted physicians to access information at the bedside and increased the use of CPG/DST tools . According to physicians , patients appeared to accept their use of information technology to assist in decision making . Development of improved computer technology may address the major limitation of MC portability BACKGROUND Physicians have difficulty keeping up with new evidence from medical research . METHODS We developed the McMaster Premium LiteratUre Service ( PLUS ) , an internet-based addition to an existing digital library , which delivered quality - and relevance -rated medical literature to physicians , matched to their clinical disciplines . We evaluated PLUS in a cluster-r and omized trial of 203 participating physicians in Northern Ontario , comparing a Full-Serve version ( that included alerts to new articles and a cumulative data base of alerts ) with a Self-Serve version ( that included a passive guide to evidence -based literature ) . Utilization of the service was the primary trial end-point . RESULTS Mean logins to the library rose by 0.77 logins/month/user ( 95 % CI 0.43 , 1.11 ) in the Full-Serve group compared with the Self-Serve group . The proportion of Full-Serve participants who utilized the service during each month of the study period showed a sustained increase during the intervention period , with a relative increase of 57 % ( 95 % CI 12 , 123 ) compared with the Self-Serve group . There were no differences in these proportions during the baseline period , and following the crossover of the Self-Serve group to Full-Serve , the Self-Serve group 's usage became indistinguishable from that of the Full-Serve group ( relative difference 4.4 ( 95 % CI -23.7 , 43.0 ) . Also during the intervention and crossover periods , measures of self-reported usefulness did not show a difference between the 2 groups . CONCLUSION A quality - and relevance -rated online literature service increased the utilization of evidence -based information from a digital library by practicing physicians OBJECTIVE To identify the most frequent obstacles preventing physicians from answering their patient-care questions and the most requested improvements to clinical information re sources . DESIGN Qualitative analysis of questions asked by 48 r and omly selected generalist physicians during ambulatory care . MEASUREMENTS Frequency of reported obstacles to answering patient-care questions and recommendations from physicians for improving clinical information re sources . RESULTS The physicians asked 1,062 questions but pursued answers to only 585 ( 55 % ) . The most commonly reported obstacle to the pursuit of an answer was the physician 's doubt that an answer existed ( 52 questions , 11 % ) . Among pursued questions , the most common obstacle was the failure of the selected re source to provide an answer ( 153 questions , 26 % ) . During audiotaped interviews , physicians made 80 recommendations for improving clinical information re sources . For example , they requested comprehensive re sources that answer questions likely to occur in practice with emphasis on treatment and bottom-line advice . They asked for help in locating information quickly by using lists , tables , bolded subheadings , and algorithms and by avoiding lengthy , uninterrupted prose . CONCLUSION Physicians do not seek answers to many of their questions , often suspecting a lack of usable information . When they do seek answers , they often can not find the information they need . Clinical re source developers could use the recommendations made by practicing physicians to provide re sources that are more useful for answering clinical questions Background Effective strategies for implementing best practice s in low and middle income countries are needed . RHL is an annually up date d electronic publication containing Cochrane systematic review s , commentaries and practical recommendations on how to implement evidence -based practice s. We are conducting a trial to evaluate the improvement in obstetric practice s using an active dissemination strategy to promote uptake of recommendations in The WHO Reproductive Health Library ( RHL ) . Methods A cluster r and omized trial to improve obstetric practice s in 40 hospitals in Mexico and Thail and is conducted . The trial uses a stratified r and om allocation based on country , size and type of hospitals . The core intervention consists of three interactive workshops delivered over a period of six months . The main outcome measures are changes in clinical practice s that are recommended in RHL measured approximately a year after the first workshop . Results The design and implementation of a complex intervention using a cluster r and omized trial design are presented . Conclusion Design ing the intervention , choosing outcome variables and implementing the protocol in two diverse setting s has been a time-consuming and challenging process . We hope that sharing this experience will help others planning similar projects and improve our ability to implement change Background Previous studies have shown that Norwegian public health physicians do not systematic ally and explicitly use scientific evidence in their practice . They work in an environment that does not encourage the integration of this information in decision-making . In this study we investigate whether a theoretically grounded tailored intervention to diffuse evidence -based public health practice increases the physicians ' use of research information . Methods 148 self-selected public health physicians were r and omised to an intervention group ( n = 73 ) and a control group ( n = 75 ) . The intervention group received a multifaceted intervention while the control group received a letter declaring that they had access to library services . Baseline assessment s before the intervention and post-testing immediately at the end of a 1.5-year intervention period were conducted . The intervention was theoretically based and consisted of a workshop in evidence -based public health , a newsletter , access to a specially design ed information service , to relevant data bases , and to an electronic discussion list . The main outcome measure was behaviour as measured by the use of research in different documents . Results The intervention did not demonstrate any evidence of effects on the objective behaviour outcomes . We found , however , a statistical significant difference between the two groups for both knowledge scores : Mean difference of 0.4 ( 95 % CI : 0.2–0.6 ) in the score for knowledge about EBM-re sources and mean difference of 0.2 ( 95 % CI : 0.0–0.3 ) in the score for conceptual knowledge of importance for critical appraisal . There were no statistical significant differences in attitude- , self-efficacy- , decision-to-adopt- or job-satisfaction scales . There were no significant differences in Cochrane library search ing after controlling for baseline values and characteristics . Conclusion Though demonstrating effect on knowledge the study failed to provide support for the hypothesis that a theory-based multifaceted intervention targeted at identified barriers will change professional behaviour Background Online information retrieval systems have the potential to improve patient care but there are few comparative studies of the impact of online evidence on clinicians ' decision-making behaviour in routine clinical work . Methods / design A r and omized controlled parallel design is employed to assess the effectiveness of an online evidence retrieval system , Quick Clinical ( QC ) in improving clinical decision-making processes in general practice . Eligible clinicians are r and omised either to receive access or not to receive access to QC in their consulting rooms for 12 months . Participants complete pre- and post trial surveys . Two-hundred general practitioners are recruited . Participants must be registered to practice in Australia , have a computer with Internet access in their consulting room and use electronic prescribing . Clinicians planning to retire or move to another practice within 12 months or participating in any other clinical trial involving electronic extraction of prescriptions data are excluded from the study .The primary end-points for the study is clinician acceptance and use of QC and the result ing change in decision-making behaviour . The study will examine prescribing patterns related to frequently prescribed medications where there has been a recent significant shift in recommendations regarding their use based upon new evidence . Secondary outcome measures include self-reported changes in diagnosis , patient education , prescriptions written , investigations and referrals . Discussion A trial under experimental conditions is an effective way of examining the impact of using QC in routine general practice consultations BACKGROUND Despite the availability of an increasing array of empirically vali date d adolescent drug abuse prevention programs , program material s and evaluation findings are poorly disseminated . CD-ROM and the Internet hold promise for disseminating this information to schools and agencies that directly serve youth , and to policy-making bodies that exercise control over funds to support adolescent drug abuse prevention programming . However , data on the relative efficacy of these newer technologies over conventional print means of dissemination are lacking . METHODS Recruited through schools , community agencies , and policy-making bodies , 188 professionals were r and omized to receive prevention program material s via pamphlets ( 55 participants ) , CD-ROM ( 64 participants ) , and the Internet ( 69 participants ) . Participants completed pretest , posttest , and 6-month follow-up measures that assessed their access to prevention program material s ; self-efficacy for identifying , obtaining , and recommending these programs ; and their likelihood of requesting , implementing , and recommending prevention programs to their constituents . RESULTS Participants exposed to dissemination via CD-ROM and the Internet evidence d the greatest short- and long-term gains on accessibility , self-efficacy , and behavioral intention variables . CONCLUSIONS CD-ROM and the Internet are viable means for disseminating adolescent drug abuse prevention programs to schools , community agencies , and policy-making bodies , and should be increasingly used for dissemination purpose BACKGROUND AND OBJECTIVES It is not yet known if personal digital assistant (PDA)-assisted evidence -based medicine ( EBM ) courses in postgraduate training enhance knowledge of common clinical problems . This study 's objective was to determine if PDA-assisted EBM training would improve clinical knowledge . METHODS In a controlled trial , intervention group residents received InfoRetriever on a PDA coupled with an EBM course integrated within clinical rotations in family medicine . The effect of the intervention and the rate of use of InfoRetriever on a written test of knowledge were evaluated after adjusting for baseline knowledge scores . The test measured knowledge of primary care management of hypertension and diabetes as well as estimation of disease probability . RESULTS There was no effect on first posttest knowledge scores of the intervention overall or of the rate with which participants had used InfoRetriever during the intervention . However , when intervention group residents retook the test with access to InfoRetriever while taking the knowledge test , scores increased 7.4 % ( + 2.4 correct test questions ) . Access to InfoRetriever Clinical Prediction Rules on a PDA , however , had an unclear effect on residents ' ability to estimate disease probability . CONCLUSIONS There was no effect of a PDA-assisted EBM course on knowledge test scores , although using the PDA during the test results in higher scores . It is unclear if using PDA Clinical Prediction Rules can improve residents ' estimates of disease probability OBJECTIVE To assess the change in frequency and methods with which a pilot group of rural physicians consulted on-line medical re sources before and after an educational intervention . DESIGN Physicians were r and omly assigned to an educational intervention or control group . Self-administered question naires were completed before and 3 months after the intervention . SETTING Rural practice s in southwestern Ontario . PARTICIPANTS Eighty rural ( defined as a population of 15000 or less ) physicians in southwestern Ontario , with a computer with Internet access . INTERVENTIONS Individualized 3-hour training session on using the World Wide Web to research patient-related questions . MAIN OUTCOME MEASURES Frequency of access and comfort with on-line medical information were compared after intervention with baseline data using the Wilcoxon two- sample test . RESULTS At follow up , the intervention group showed a significant improvement over the control group in their frequency of accessing the World Wide Web to address patient-related questions ( P = .009 ) , in their comfort level in using on-line data bases ( P = .032 ) , and in their frequency of accessing on-line data bases ( P = .044 ) . CONCLUSION Rural physicians ' comfort and competence in using computers to address patient problems can be improved by an individualized 3-hour training session OBJECTIVE The aim of this study was to compare the clinical impact of computerized decision support with and without electronic access to clinical guidelines and laboratory data on antibiotic prescribing decisions . DESIGN A crossover trial was conducted of four levels of computerized decision support-no support , antibiotic guidelines , laboratory reports , and laboratory reports plus a decision support system ( DSS ) , r and omly allocated to eight simulated clinical cases
Output:
| Neither study assessed changes in patient outcomes or the costs of provision of the electronic re source and the implementation of the recommended evidence -based practice s. AUTHORS ' CONCLUSIONS Overall there was insufficient evidence to support or refute the use of electronic retrieval of healthcare information by healthcare providers to improve practice and patient care |
MS211457 | ***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 efficacy of an innovative smoking cessation intervention targeted to a multiethnic , economically disadvantaged HIV-positive population . Design : A two-group r and omized clinical trial compared a smoking cessation intervention delivered by cellular telephone with usual care approach . Methods : Current smokers from a large , inner city HIV/AIDS care center were recruited and r and omized to receive either usual care or a cellular telephone intervention . The usual care group received brief physician advice to quit smoking , targeted self-help written material s and nicotine replacement therapy . The cellular telephone intervention received eight counseling sessions delivered via cellular telephone in addition to the usual care components . Smoking-related outcomes were assessed at a 3-month follow-up . Results : The trial had 95 participants and 77 ( 81.0 % ) completed the 3-month follow-up assessment . Analyses indicated biochemically verified point prevalence smoking abstinence rates of 10.3 % for the usual care group and 36.8 % for the cellular telephone group ; participants who received the cellular telephone intervention were 3.6 times ( 95 % confidence interval , 1.3 - 9.9 ) more likely to quit smoking compared with participants who received usual care ( P = 0.0059 ) . Conclusions : These results suggest that individuals living with HIV/AIDS are receptive to , and can be helped by , smoking cessation treatment . In addition , smoking cessation treatment tailored to the special needs of individuals living with HIV/AIDS , such as counseling delivered by cellular telephone , can significantly increase smoking abstinence rates over that achieved by usual care BACKGROUND Previous research has demonstrated the efficacy of an interactive expert system intervention for smoking cessation for a general population . The intervention provides individualized feedback that guides participants through the stages of change for cessation . Enhancing the expert system by adding proactive telephone counseling or a stimulus control computer design ed to produce nicotine fading could produce preventive programs with greater population impacts . METHODS Four interventions were compared : ( a ) the interactive expert system intervention ; ( b ) the expert system intervention plus counselor calls ; ( c ) the expert system intervention plus the stimulus control computer ; and ( d ) an assessment only condition . A 4 ( intervention ) x 4 ( occasions ) ( 0,6,12 , and 18 months ) design was used . Smokers were contacted at home via telephone or mail . The initial subject pool was the 24,178 members of a managed care company . Screening was completed for 19,236 members ( 79.6 % ) , of whom 4,653 were smokers ; 85.3 % of the smokers were enrolled . RESULTS Thirty-eight percent were in the precontemplation stage , 45 % in the contemplation stage , and only 17 % in the preparation stage . At 18 months , the expert system result ed in 23.2 % point prevalence abstinence , which was 33 % greater than that of assessment only . The counselor enhancement produced increased cessation at 12 months but not at 18 months . The stimulus control computer produced no improvement , result ing in 20 % worse cessation rates than the assessment only condition . CONCLUSIONS The enhanced conditions failed to outperform the expert system alone . The study also demonstrated the ability of the interactive expert system to produce significantly greater cessation in a population of smokers than assessment alone Background Advances in technology allowed the development of a novel smoking cessation program delivered by video messages sent to mobile phones . This social cognitive theory-based intervention ( called “ STUB IT ” ) used observational learning via short video diary messages from role models going through the quitting process to teach behavioral change techniques . Objective The objective of our study was to assess the effectiveness of a multimedia mobile phone intervention for smoking cessation . Methods A r and omized controlled trial was conducted with 6-month follow-up . Participants had to be 16 years of age or over , be current daily smokers , be ready to quit , and have a video message-capable phone . Recruitment targeted younger adults predominantly through radio and online advertising . Registration and data collection were completed online , prompted by text messages . The intervention group received an automated package of video and text messages over 6 months that was tailored to self-selected quit date , role model , and timing of messages . Extra messages were available on dem and to beat cravings and address lapses . The control group also set a quit date and received a general health video message sent to their phone every 2 weeks . Results The target sample size was not achieved due to difficulty recruiting young adult quitters . Of the 226 r and omized participants , 47 % ( 107/226 ) were female and 24 % ( 54/226 ) were Maori ( indigenous population of New Zeal and ) . Their mean age was 27 years ( SD 8.7 ) , and there was a high level of nicotine addiction . Continuous abstinence at 6 months was 26.4 % ( 29/110 ) in the intervention group and 27.6 % ( 32/116 ) in the control group ( P = .8 ) . Feedback from participants indicated that the support provided by the video role models was important and appreciated . Conclusions This study was not able to demonstrate a statistically significant effect of the complex video messaging mobile phone intervention compared with simple general health video messages via mobile phone . However , there was sufficient positive feedback about the ease of use of this novel intervention , and the support obtained by observing the role model video messages , to warrant further investigation . Trial registration Australian New Zeal and Clinical Trials Registry Number : ACTRN12606000476538 ; http://www.anzctr.org.au/trial_view.aspx?ID=81688 ( Archived by WebCite at http://www.webcitation.org/5umMU4sZi Summary We evaluated the effectiveness of a mobile phone text-messaging based smoking cessation intervention package among Chinese adolescent smokers . Students aged 16–19 years were recruited from six vocational high schools located in Shanghai . We assigned the six schools to an intervention group or a control group by cluster r and omization . The 92 participants in the intervention group were given tailored information via mobile phone text-messaging for 12 weeks . The 87 participants in the control group were provided with a self-help pamphlet about smoking cessation instead . After the intervention , attitudes towards the disadvantages of smoking were significantly improved , and the level of nicotine dependence and cigarette dependence significantly decreased in the intervention group . The intervention group had a relatively higher self-reported 7-day abstinence compared to the control group and 30-day abstinence , but the differences were not significant . However , the intervention group had a significantly higher rate of smoking reduction ( 66 % vs. 35 % ) and moving forward in quitting stages ( 52 % vs. 18 % ) compared to the control group . The interactive and tailored assistance provided by the mobile phone text-messaging was effective in smoking behaviour intervention in Chinese adolescent smokers 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 The need for effective , low-cost self-help treatment methods for smokeless tobacco ( ST ) addiction becomes more evident as rates of product use and associated morbidities increase . This study evaluated two self-help methods for ST cessation . One hundred ninety-eight ST users were r and omized into two conditions : half received the LifeSign , a credit card-sized computer design ed for gradual ST cessation , and half received the Enough Snuff self-help manual and a video . Subjects in both conditions received telephone support for their quit effort . The study was conducted entirely through phone and mail , allowing delivery of the intervention to both rural and urban users . Self-reported rates of sustained abstinence ( no tobacco use at two months and six months ) were 24.5 % for the manual/video condition , and 18.4 % , for the LifeSign condition 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 20
Output:
| The magnitude of effect sizes from mHealth smoking cessation interventions was likely to be greater if the trial was conducted in the USA or Europe and when the intervention included individually tailored text messages .
In contrast , high frequency of texts ( daily ) was less effective than weekly texts .
Conclusions There was consistent evidence that web-based and mHealth smoking cessation interventions may increase abstinence moderately . |
MS211458 | ***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: Nutrient composition of the grasshoppers Oxya hyla hyla showed that they are a rich nutrient source containing 687.7 g protein/kg of dry body weight . Their antinutrient values fell within nutritionally acceptable values of the poultry bird Coturnix japonica japonica ( Japanese quail ) . The most required essential amino acids and fatty acids were also present in sufficient amount . For feeding trial nine diets were formulated on an equal crude protein ( 230 g/kg ) basis with grasshopper meal , fish meal , and soybean meal . Three sets of diets with grasshopper meal were prepared with 50 g/kg , 100 g/kg , and 150 g/kg grasshopper of total feed . Similarly , other diet sets were prepared with fish meal and also with soybean meal . Results were compared with another group of Japanese quails fed on a reference diet that was considered as control . Two experiments were conducted with a total number of 600 , seven-day-old , Japanese quails . In experiment 1 for determination of growth performance , quails were r and omly distributed into ten groups of males and ten groups of females containing 30 birds each . In experiment 2 for determination of laying performance , identical ten groups were prepared in ten repetitions ( 2 females and 1 male in each group ) from the six-week-old birds of experiment 1 . Birds of diet set GM2 have gained the highest body weight ( male 4.04 g/bird/day ; female 5.01 g/bird/day ) followed by birds of FM3 diet set ( male 3.72 g/bird/day ; female 4.40 g/bird/day ) , whereas birds of reference diet have gained 3.05 g/bird/day for male and 3.23 g/bird/day for female . Feed conversion ratio ( FCR ) of birds fed with GM2 was the lowest ( male 3.33 ; female 2.97 ) whereas FCR of R group was higher ( male 4.37 ; female 4.65 ) than grasshopper meal and fish meal based diets . Hen day production percentage was higher ( 72.2 ) in GM2 group , followed by FM3 ( 63.5 ) group . R group had lower 1st egg weight ( 9.0 g ) , weight gain ( 8.2 g ) , percentage of hen day production ( 41.8 % ) , higher feed intake ( 33.6 g/day/bird ) , and age at 1st laid egg than the grasshopper meal and fish meal based diets . So growth and laying performance of the birds were significantly better in grasshopper meal and fish meal added diet fed sets than the reference diet fed group ; among all the dietary groups 100 g/kg grasshopper meal added diet mostly gave significantly better results followed by 150 g/kg fish meal added diets . It was ascertained that the O. hyla hyla meal had pronounced positive response on the birds . So , the quails could be easily fed 100 g/kg grasshopper meal added diet as it was the most suitable alternative feedstuff compared to the conventional protein source based diets To investigate the effect of two insect meals ( from Hermetia illucens , HI and Tenebrio molitor , TM larvae ) on productive performance and blood profiles of Barbary partridge , ninety , seven days old partridges were divided into 5 groups ( 6 replicates , 3 partridges/replicate ) . Up to 64d , the groups fed 5 isoproteic and isoenergetic diets : the control fed a corn-soybean meal diet ( SBM group ) ; in TM25 and TM50 groups the 25 and 50 % of SBM proteins were substituted by the protein from TM , respectively ; in HI25 and HI50 groups the 25 and 50 % of SBM were substituted by the protein from HI , respectively . The birds fed TM25 and both the HI levels reached a higher ( P<0.01 ) live weight at 64d than the control . Considering the entire experimental period the TM groups had a more favorable FCR than SBM . The carcass weights of all the insect groups were higher ( P<0.01 ) than the control . The weight of the full digestive tract in SBM group was the highest ( P<0.01 ) . The caecal weight , the intestinal and caecal length were the highest ( P<0.01 ) in the SBM group . The SBM group the highest value of albumin/globulin ( P<0.01 ) and creatinine ( P<0.05 ) . TM seems to be more effective than HI in improving FCR . The reduced albumin/globulin ratio in the insect meal fed groups could be ascribed to the chitin content and this result was not affected by the amount of chitin intake , suggesting that also the lowest values are able to express their potential effects in partridges Abstract This study evaluated the effects of Tenebrio molitor ( TM ) larvae meal inclusion in diets for broilers . A total of 160 male broiler chicks ( Ross 708 ) at one‐day of age were r and omly allotted to four dietary treatments : a control ( C ) group and three TM groups , in which TM meal was included at 50 ( TM5 ) , 100 ( TM10 ) , and 150 ( TM15 ) g/kg , respectively . The experimental diets were isonitrogenous and isoenergetic . Each group consisted of five pens as replicates ( 8 chicks/pen ) . After the evaluation of growth performance and haematochemical parameters , the animals were slaughtered at 53 days and carcass traits were recorded . Morphometric investigations were performed on duodenum , jejunum , and ileum and histopathological alterations were assessed for liver , spleen , thymus , bursa of Fabricius , kidney , and heart . The live weight ( LW ) showed a linear ( 12 and 25 days , P < 0.001 and P < 0.05 , maximum with TM15 and TM10 ) and quadratic ( 53 days , P < 0.05 , maximum with TM5 ) response to dietary TM meal inclusion . A linear ( 1 to 12 and 12 to 25 days , P < 0.001 , maximum with TM15 ) and quadratic ( 12 to 25 days , P = 0.001 , maximum with TM15 ) effect was also observed for the daily feed intake ( DFI ) . The feed conversion ratio ( FCR ) showed a linear response ( 25 to 53 and 1 to 53 days , P = 0.001 and P < 0.05 , maximum with TM15 ) . Haematological and serum biochemical traits , carcass traits and histopathological findings were not affected by dietary TM meal inclusion ( P > 0.05 ) . TM15 birds showed lower villus height ( P < 0.05 ) , higher crypt depth ( P < 0.05 ) , and lower villus height to crypt depth ratio ( P = 0.001 ) compared with C and TM5 . In conclusion , increasing levels of dietary TM meal inclusion in male broiler chickens may improve body weight and feed intake , but negatively affect feed efficiency and intestinal morphology , thus suggesting that low levels may be more suitable . However , no effect on haematochemical parameters , carcass traits , and histological findings were observed in relation to TM meal utilization Insects are currently being considered as a novel protein source for animal feeds , because they contain a large amount of protein . The larvae of Tenebrio molitor ( TM ) have been shown to be an acceptable protein source for broiler chickens in terms of growth performance , but till now , no data on histological or intestinal morphometric features have been reported . This study has had the aim of evaluating the effects of dietary TM inclusion on the performance , welfare , intestinal morphology and histological features of free-range chickens . A total of 140 medium-growing hybrid female chickens were free-range reared and r and omly allotted to two dietary treatments : ( i ) a control group and ( ii ) a TM group , in which TM meal was included at 75 g/kg . Each group consisted of five pens as replicates , with 14 chicks per pen . Growth performance , haematological and serum parameters and welfare indicators were evaluated , and the animals were slaughtered at the age of 97 days . Two birds per pen ( 10 birds/treatment ) were su bmi tted to histological ( liver , spleen , thymus , bursa of Fabricius , kidney , heart , gl and ular stomach and gut ) and morphometric ( duodenum , jejunum and ileum ) investigations . The inclusion of TM did not affect the growth performance , haematological or serum parameters . The morphometric and histological features were not significantly affected either , thus suggesting no influence on nutrient metabolization , performance or animal health . Gl and ular stomach alterations ( chronic flogosis with epithelial squamous metaplasia ) were considered paraphysiological in relation to free-range farming . The observed chronic intestinal flogosis , with concomitant activation of the lymphoid tissue , was probably due to previous parasitic infections , which are very frequently detected in free-range chickens . In conclusion , the findings of this study show that yellow mealworm inclusion does not affect the welfare , productive performances or morphological features of free-range chickens , thus confirming that TM can be used safely in poultry diets Recent studies have suggested the utilization of maggots as a feed supplement forenhanced broiler performance . Maggots , which are a major dietary source of protein , appear during the biodegradation of chicken droppings using house flies . The objective ofthe present study was to investigate the effect of maggot supplementation on the meat quality and growth performance of broiler chickens . A total of 600 one-day-old male commercial broiler chicks ( Ross ) were r and omly assigned into 5 treatment groups consisting of 40 replicates of 3 birds . The birds were fed either a basal diet or the basal diet supplemented with 5.0 , 10.0 , 15.0 and 20.0 % maggots . Overall , broiler chicken performance was influenced by the optimal amino acid profile ; high protein ( 63.99 % ) and essential amino acid content ( 29.46 % ) , or high protein digestibility ( 98.50 % ) of the maggots . Maggot supplementation caused linear increases in live weight gain but not the feed conversion ratio . The diets of 10 and 15 % maggots was the most efficient in terms of average weight gain forthe 4 - 5 week old broiler chickens ( p<0.05 ) . It also significantly increased dressing percentage , breast muscle , and thigh muscle ( p<0.05 ) . No differences were observed forliver abdominalfat , or meat color , and the crude protein contents of breast muscle were constant . However , in the maggot-fed broilers , breast muscle lysine and tryptophan levels increased significantly as compared to the birds fed the basal diet ( p<0.05 ) . These results indicate that feeding diets containing 10 to 15 % maggots in chicken dropping after biodegradation can improve the carcass quality and growth performance of broiler chickens In order to exp and with vali date d scientific data the limited knowledge regarding the potential application of insects as innovative feed ingredients for poultry , the present study tested a partial substitution of soya bean meal and soya bean oil with defatted black soldier fly ( Hermetia illucens ) larvae meal ( H ) in the diet for growing broiler quails ( Coturnix coturnix japonica ) on growth performance , mortality , nutrients apparent digestibility , microbiological composition of excreta , feed choice , carcass and meat traits . With this purpose , a total of 450 10-day-old birds were allocated to 15 cages ( 30 birds/cage ) and received three dietary treatments : a Control diet ( C ) and two diets ( H1 and H2 ) corresponding to 10 % and 15 % H inclusion levels , respectively ( H substituted 28.4 % soya bean oil and 16.1 % soya bean meal for H1 , and 100 % soya bean oil and 24.8 % soya bean meal for H2 , respectively ) . At 28 days of age , quails were slaughtered , carcasses were weighed , breast muscles were then excised from 50 quails/treatment , weighed , and ultimate pH ( pHu ) and L * , a * , b * colour values were measured . Breast muscles were then cooked to assess cooking loss and meat toughness . For the digestibility trial , a total of 15 28-day-old quails were assigned to the three feeding groups . The excreta sample s were subjected to chemical and microbiological analysis . The same 15 quails were then simultaneously provided with C and H2 diets for a 10-day feed choice trial . Productive performance , mortality and carcass traits were in line with commercial st and ards and similar in all experimental groups . With the exception of ether extract digestibility , which was lower in H1 group compared with C and H2 ( P=0.0001 ) , apparent digestibility of dry matter , CP , starch and energy did not differ among treatments . Microbial composition of excreta was also comparable among the three groups . Feed choice trial showed that quails did not express a preference toward C or H2 diets . Breast meat weight and yield did not differ among C , H1 and H2 quails . Differently , the inclusion of H meal reduced meat pHu compared with C. In conclusion , this study demonstrated that H. illucens larvae meal can partially replace conventional soya bean meal and soya bean oil in the diet for
Output:
| With respect to diets without insects , pooled differences in growth performances were statistically not different from the null , but heterogeneity was marked across studies .
Average daily gain decreased with increasing inclusion rates of insects , going below the null for rates of 10 % and more .
Grasshoppers were negatively associated with the average daily gain and positively associated with feed intake .
Overall , our results show insects should substitute only partially conventional protein sources and not be grasshoppers to guarantee the appropriate growth of birds |
MS211459 | ***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: INTRODUCTION We used transcranial magnetic stimulation ( TMS ) to investigate 3 weeks of unilateral leg strength training on ipsilateral motor cortex ( iM1 ) excitability , and short-latency intracortical inhibition ( SICI ) . METHODS Right leg dominant participants ( n = 14 ) were r and omly divided into either a strength training ( ST ) or control group . The ST group completed 9 training sessions ( 4 sets of 6 to 8 repetitions of single right leg squats ) . RESULTS We observed a 41 % increase in right leg strength , and a 35 % increase in strength of the untrained left leg ( P < 0.01 ) . There was a significant increase in motor evoked potential ( MEP ) amplitude recruitment curve for the untrained left leg ( P < 0.01 ) . SICI of the iM1 decreased by 21 % for the untrained left leg ( P < 0.01 ) . CONCLUSIONS The findings provide evidence for corticomotor adaptation for unilateral leg strength training within the iM1 that is modulated by changes in interhemispheric inhibition Trapezius muscle Hoffman ( H ) reflexes were obtained to investigate the neural adaptations induced by a 5-wk strength training regimen , based solely on eccentric contractions of the shoulder muscles . Twenty-nine healthy subjects were r and omized into an eccentric training group ( n = 15 ) and a reference group ( n = 14 ) . The eccentric training program consisted of nine training sessions of eccentric exercise performed over a 5-wk period . H-reflex recruitment curves , the maximal M wave ( Mmax ) , maximal voluntary contraction ( MVC ) force , rate of force development ( RFD ) , and electromyographic ( EMG ) voluntary activity were recorded before and after training . H reflexes were recorded from the middle part of the trapezius muscle by electrical stimulation of the C3/4 cervical nerves ; Mmax was measured by electrical stimulation of the accessory nerve . Eccentric strength training result ed in significant increases in the maximal trapezius muscle H reflex ( Hmax ) ( 21.4 % [ 5.5 - 37.3 ] ; P = 0.01 ) , MVC force ( 26.4 % [ 15.0 - 37.7 ] ; P < 0.01 ) , and RFD ( 24.6 % [ 3.2 - 46.0 ] ; P = 0.025 ) , while no significant changes were observed in the reference group . Mmax remained unchanged in both groups . A significant positive correlation was found between the change in MVC force and the change in EMG voluntary activity in the training group ( r = 0.57 ; P = 0.03 ) . These results indicate that the net excitability of the trapezius muscle H-reflex pathway increased after 5 wk of eccentric training . This is the first study to investigate and document changes in the trapezius muscle H reflex following eccentric strength training Purpose To test whether long-term cortical adaptations occur bilaterally following chronic unilateral training with a simple motor task . Methods Participants ( n = 34 ) were r and omly allocated to a training or control groups . Only the former completed a 4-week maximal-intensity isometric training of the right first dorsal interosseus muscle through key pinching . Maximal strength was assessed bilaterally in four different movements progressively less similar to the training task : key , tip and tripod pinches , and h and grip . Transcranial magnetic stimulation was used to probe , in the left and right primary h and motor cortices , a number of st and ard tests of cortical excitability , including thresholds , intra-cortical inhibition and facilitation , transcallosal inhibition , and sensory-motor integration . Results Training increased strength in the trained h and , but only for the tasks specifically involving the trained muscle ( key + 8.5 % ; p < 0.0005 ; tip + 7.2 % ; p = 0.02 ) . However , the effect size was small and below the cutoff for meaningful change . H and grip and tripod pinch were instead unaffected . There was a similar improvement in strength in the untrained h and , i.e. , a cross-education effect ( key + 6.4 % ; p = 0.02 ; tip + 4.7 % ; p = 0.007 ) . Despite these changes in strength , no significant variation was observed in any of the neurophysiological parameters describing cortico-spinal and intra-cortical excitability , inter-hemispheric inhibition , and cortical sensory-motor integration . Conclusions A 4-week maximal-intensity unilateral training induced bilaterally spatial- and task-specific strength gains , which were not associated to direct or crossed cortical adaptations . The observed long-term stability of neurophysiological parameters might result from homeostatic plasticity phenomena , aim ed at restoring the physiological inter-hemispheric balance of neural activity levels perturbed by the exercise . Trial registration number Clinical Trials.gov identifier NCT02010398 This study employed longitudinal measures of evoked spinal reflex responses ( Hoffman reflex , V wave ) to investigate changes in the activation of muscle and to determine if there are " linked " neural adaptations in the motor pathway following isometric resistance training . Twenty healthy , sedentary males were r and omly assigned to either the trained ( n = 10 ) or control group ( n = 10 ) . The training protocol consisted of 12 sessions of isometric resistance training of the plantar flexor muscles over a 4-wk period . All subjects were tested prior to and after the 4-wk period . To estimate changes in spinal excitability , soleus Hoffman ( H ) reflex and M wave recruitment curves were produced at rest and during submaximal contractions . Recruitment curves were analyzed using the slope method ( Hslp/Mslp ) . Modulation of efferent neural drive was assessed through evoked V wave responses ( V/Mmax ) at 50 , 75 , and 100 % maximal voluntary contraction ( MVC ) . After 4 weeks , MVC torque increased 20.0 + /- 13.9 % ( mean + /- SD ) in the trained group . The increase in MVC was accompanied by significant increases in the rate of torque development ( 42.5 + /- 13.3 % ) , the soleus surface electromyogram ( 60.7 + /- 30.8 % ) , voluntary activation ( 2.8 + /- 0.1 % ) , and the rate of activation ( 48.7 + /- 24.3 % ) . Hslp/Mslp was not altered by training ; however , V/Mmax increased 57.3 + /- 34.2 % during MVC . These results suggest that increases in MVC observed in the first few days of isometric resistance training can be accounted for by an increase in the rate of activation at the onset of muscle contraction . Augmentation of muscle activation may be due to increased volitional drive from supraspinal centers The purpose of this study was to examine the effects of a 5-wk unilateral , isometric strength-training program on plasticity in the spinal Hoffmann ( H- ) reflex in both the trained and untrained legs . Sixteen participants , 22 - 42 yr old , were assigned to either a control ( n = 6 ) or an exercise group ( n = 10 ) . Both groups were tested for plantar flexion maximal voluntary isometric contractions ( MVIC ) and soleus H-reflex amplitude in both limbs , at the beginning and at the end of a 5-wk interval . Participants in the exercise group showed significantly increased MVIC in both legs after training ( P < 0.05 ) , whereas strength was unchanged in the control group for either leg . Subjects in the exercise group displayed increased ( P < 0.05 ) H-reflex amplitudes on the ascending limb of the recruitment curve ( at an equivalent M wave of 5 % of the maximal M wave , H(A ) ) only in the trained leg . Maximal H-reflex and M-wave remained unchanged with training . Increased amplitude of H(A ) in the trained limb concurrent with increased strength suggests that spinal mechanisms may underlie the changes in strength , possibly because of increased alpha-motoneuronal excitability or reduced presynaptic inhibition . Despite a similar increase in strength in the contralateral limb of the exercise group , H(A ) amplitude was unchanged . We conclude that the cross-education effect of strength training may be due to supraspinal to a greater extent than spinal mechanisms The purpose of this study was to investigate whether neural adaptations following functional multiple-joint leg press training can induce neural adaptations to the plantar flexor muscles in a single-joint contraction task . Subjects were r and omised to a maximal strength training ( MST ) ( n = 10 ) or a control group ( n = 9 ) . MST consisted of 24 sessions ( 8 weeks ) of 4 × 4 repetitions of horizontal leg press using maximal intended velocity in the concentric phase with the movement ending in a plantar flexion . Neural adaptations in the soleus and gastrocnemius medialis ( GM ) were assessed by surface electromyographic activity and V-waves during maximum voluntary isometric contraction ( MVIC ) , and also by H-reflexes in the soleus during rest and 20 % MVIC . One repetition maximum leg press increased by 44 ± 14 % ( mean ± SD ; P < 0.01 ) . Plantar flexion MVIC increased by 20 ± 14 % ( P < 0.01 ) , accompanied by 13 ± 19 % ( P < 0.05 ) increase in soleus , but not GM surface electromyography . Soleus V/MSUP increased by 53 ± 66 % and in GM by 59 ± 64 % ( P < 0.05 ) . Normalised soleus H-reflexes remained unchanged by training . No changes occurred in the control group . These results suggest that leg press MST can induce neural adaptations in a single-joint plantar flexion MVIC task Effects of 6 mo of heavy-resistance training combined with explosive exercises on neural activation of the agonist and antagonist leg extensors , muscle cross-sectional area ( CSA ) of the quadriceps femoris , as well as maximal and explosive strength were examined in 10 middle-aged men ( M40 ; 42 + /- 2 yr ) , 11 middle-aged women ( W40 ; 39 + /- 3 yr ) , 11 elderly men ( M70 ; 72 + /- 3 yr ) and 10 elderly women ( W70 ; 67 + /- 3 yr ) . Maximal and explosive strength remained unaltered during a 1-mo control period with no strength training . After the 6 mo of training , maximal isometric and dynamic leg-extension strength increased by 36 + /- 4 and 22 + /- 2 % ( P < 0 . 001 ) in M40 , by 36 + /- 3 and 21 + /- 3 % ( P < 0.001 ) in M70 , by 66 + /- 9 and 34 + /- 4 % ( P < 0.001 ) in W40 , and by 57 + /- 10 and 30 + /- 3 % ( P < 0.001 ) in W70 , respectively . All groups showed large increases ( P < 0.05 - 0.001 ) in the maximum integrated EMGs ( iEMGs ) of the agonist vastus lateralis and medialis . Significant ( P < 0.05 - 0.001 ) increases occurred in the maximal rate of isometric force production and in a squat jump that were accompanied with increased ( P < 0.05 - 0 . 01 ) iEMGs of the leg extensors . The iEMG of the antagonist biceps femoris muscle during the maximal isometric leg extension decreased in both M70 ( from 24 + /- 6 to 21 + /- 6 % ; P < 0.05 ) and in W70 ( from 31 + /- 9 to 24 + /- 4 % ; P < 0.05 ) to the same level as recorded for M40 and W40 . The CSA of the quadriceps femoris increased in M40 by 5 % ( P < 0.05 ) , in W40 by 9 % ( P < 0.01 ) , in W70 by 6 % ( P < 0.05 ) , and in M70 by 2 % ( not significant ) . Great training-induced gains in maximal and explosive strength in both middle-aged and elderly subjects were accompanied by large increases in the voluntary activation of the agonists , with significant reductions in the antagonist coactivation in the elderly subjects . Because the enlargements in the muscle CSAs in both middle-aged and elderly subjects were much smaller in magnitude , neural adaptations seem to play a greater role in explaining strength and power gains during the present strength-training protocol Voluntary activation of muscle is commonly quantified by comparison of the extra force added by motor nerve stimulation during a contraction [ superimposed twitch ( SIT ) ] with that produced at rest by the same stimulus ( resting twitch ) . An inability to achieve 100 % voluntary activation implies that failure to produce maximal force output from the muscle must have occurred at a site at or above the level of the motoneurons . We have used cortical stimulation to quantify voluntary activation . Here , incomplete activation implies a failure at or above the level of motor cortical output . With cortical stimulation , it is inappropriate to compare extra force evoked during a contraction with the twitch evoked in resting muscle because motor cortical and spinal cord excitability both increase with activity . However , an appropriate " resting twitch " can be estimated . We previously estimated its amplitude by extrapolation of the linear relation between SIT amplitude and voluntary torque calculated from 35 contractions of > 50
Output:
| There are subtle neural adaptations following resistance training that involve both cortical and subcortical adaptations that act to increase motoneuron activation , which could underpin the training-related increase in muscle strength |
MS211460 | ***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 determine ( 1 ) the relationship among three common upper-limb tests for patients with chronic obstructive pulmonary disease ( COPD ): unsupported upper limb exercise test ( UULEX ) , 6-minute pegboard and ring test ( 6PBRT ) , and a muscle-strength test using a h and -held dynamometer ; and ( 2 ) the responsiveness of these three tests to changes after pulmonary rehabilitation that included a resistance arm-training programme . METHODS The study was a secondary analysis of a r and omized controlled trial ( RCT ) . The UULEX and the 6PBRT were used to measure peak arm exercise capacity and arm function , respectively . A h and held dynamometer was used to measure elbow and shoulder flexion force . We analyzed baseline data for all participants in the RCT , as well as baseline and post-PR data for those who completed 6-week follow-up testing . RESULTS 36 patients with COPD ( mean forced expiratory volume in 1 second [FEV1]=35 % [ SD 15 % ] predicted ; age 66 [ 9 ] y ) participated , of whom 13 completed an arm-training programme . The correlations among the test results ranged from 0.41 to 0.81 ( p<0.0001 ) . St and ardized response means were 1.0 for muscle force of elbow flexion , 1.2 for shoulder flexion , and 1.8 for the 6PBRT and UULEX . CONCLUSIONS Although the three tests ( UULEX , 6PBRT , and muscle-strength test using a h and -held dynamometer ) are intended to measure different constructs , they were moderately to highly correlated with one another . The 6PBRT , UULEX , and muscle-strength test were demonstrated to be responsive to the resistance arm-training programme BACKGROUND The study aim ed to evaluate the effect of upper extremity resistance training for patients with COPD on dyspnea during activity of daily living ( ADL ) , arm function , arm exercise capacity , muscle strength , and health-related quality of life ( HRQL ) . METHODS Patients were r and omly assigned to an intervention or control group . The intervention group underwent arm resistance training . The control group performed a sham . Both groups exercised three times a week for 6 weeks . Dyspnea during ADL and HRQL were measured using the Chronic Respiratory Disease Question naire ( CRDQ ) . Arm function and exercise capacity were measured using the 6-min pegboard and ring test ( 6PBRT ) and the unsupported upper limb exercise test ( UULEX ) , respectively . Muscle strength for the biceps , triceps , and anterior and middle deltoids was obtained using an isometric dynamometer . RESULTS Thirty-six patients with COPD ( 66 ± 9 years ) participated in the study . Compared with the control group , the magnitude of change in the intervention group was greater for the 6PBRT ( P = .03 ) , UULEX ( P = .01 ) , elbow flexion force ( P = .01 ) , elbow extension force ( P = .02 ) , shoulder flexion force ( P = .029 ) , and shoulder abduction force ( P = .01 ) . There was no between-group difference in dyspnea during ADL , HRQL , or symptoms during the 6PBRT or UULEX ( all P values > .08 ) . CONCLUSIONS Resistance-based arm training improved arm function , arm exercise capacity , and muscle strength in patients with COPD . No improvement in dyspnea during ADL , HRQL , or symptoms was demonstrated STUDY OBJECTIVES We hypothesized that endurance exercise training would reduce the degree of hyperinflation for a given level of exercise and thereby improve submaximal exercise endurance . METHODS Twenty-four patients with COPD ( mean FEV(1 ) , 36.4 + /- 8.5 % of predicted [ + /- SD ] ) undertook a high-intensity cycle ergometer exercise training program for 45 min , three times a week for 7 weeks . Before and after training , the patients performed both an incremental exercise test to maximum and a constant work rate ( CWR ) test on a cycle ergometer at 75 % of the peak work rate obtained in the pretraining incremental test . Ventilatory variables were measured breath-by-breath , and inspiratory capacity ( IC ) was measured every 2 min to assess changes in end-expiratory lung volume . RESULTS After training , the increase in peak oxygen uptake was not statistically significant ; however , the peak work rate increased by 12.9 + /- 10.3 W ( p < 0.01 ) . For the CWR test performed at the same work rate both before and after training , ventilation and breathing frequency ( f ) were lower after training ( average , 1.97 L/min and 3.2 breaths/min , respectively ; p < 0.01 ) and IC was greater ( by an average of 133 mL , p < 0.05 ) , signifying decreased hyperinflation . The increase in IC at the point of termination in the shortest CWR test for each individual ( defined as isotime ) correlated well with both the decreased f ( r = 0.63 , p = 0.001 ) and with the increase in CWR exercise endurance ( average , 13.1 min , r = 0.46 , p = 0.023 ) . CONCLUSIONS Exercise training in patients with severe COPD dramatically improves submaximal exercise endurance . Decreased dynamic hyperinflation may , in part , mediate the improvement in exercise endurance by delaying the attainment of a critically high inspiratory lung volume The effects of endurance training on exercise capacity and health-related quality of life ( HRQL ) in chronic obstructive pulmonary disease ( COPD ) patients have been studied thoroughly , while resistance training has been rarely evaluated . This study investigated the effects of resistance training in comparison with endurance training in patients with moderate to severe COPD and peripheral muscle weakness ( isometric knee extension peak torque < 75 % predicted ) . Forty-eight patients ( age 64±8 yrs , forced expiratory volume in one second 38±17 % pred ) were r and omly assigned to resistance training ( RT , n=24 ) or endurance training ( ET , n=24 ) . The former consisted of dynamic strengthening exercises . The latter consisted of walking , cycling and arm cranking . Respiratory and peripheral muscle force , exercise capacity , and HRQL were re-evaluated in all patients who completed the 12-week rehabilitation ( RT n=14 , ET n=16 ) . Statistically significant increases in knee extension peak torque ( RT 20±21 % , ET 42±21 % ) , maximal knee flexion force ( RT 31±39 % , ET 28±37 % ) , elbow flexion force ( RT 24±19 % , ET 33±25 % ) , 6-min walking distance ( 6MWD ) ( RT 79±74 m , ET 95±57 m ) , maximum workload ( RT 15±16 Watt , ET 14±13 Watt ) and HRQL ( RT 16±25 points , ET 16±15 points ) were observed . No significant differences in changes in HRQL and 6MWD were seen between the two treatments . Resistance training and endurance training have similar effects on peripheral muscle force , exercise capacity and health-related quality of life in chronic obstructive pulmonary disease patients with peripheral muscle weakness Dysfunction of the muscles of ambulation contributes to exercise intolerance in chronic obstructive pulmonary disease ( COPD ) . Men with COPD have high prevalence of low testosterone levels , which may contribute to muscle weakness . We determined effects of testosterone supplementation ( 100 mg of testosterone enanthate injected weekly ) with or without resistance training ( 45 minutes three times weekly ) on body composition and muscle function in 47 men with COPD ( mean FEV(1 ) = 40 % predicted ) and low testosterone levels ( mean = 320 ng/dl ) . Subjects were r and omized to 10 weeks of placebo injections + no training , testosterone injections + no training , placebo injections + resistance training , or testosterone injections + resistance training . Testosterone injections yielded a mean increase of 271 ng/dl in the nadir serum testosterone concentration ( to the middle of the normal range for young men ) . The lean body mass ( by dual-energy X-ray absorptiometry ) increase averaged 2.3 kg with testosterone alone and 3.3 kg with combined testosterone and resistance training ( p < 0.001 ) . Increase in one-repetition maximum leg press strength averaged 17.2 % with testosterone alone , 17.4 % with resistance training alone , and 26.8 % with testosterone + resistance training ( p < 0.001 ) . Interventions were well tolerated with no abnormalities in safety measures . Further studies are required to determine long-term benefits of adding testosterone supplementation and resistance training to rehabilitative programs for carefully screened men with COPD and low testosterone levels PURPOSE A diminished mechanical efficiency ( work/O2 consumed ) accompanies chronic obstructive pulmonary disease ( COPD ) , and increased mechanical efficiency has been attained by maximal strength training ( MST ) with an emphasis on the maximal rate of force mobilization in the concentric phase in healthy subjects . This study combined these observations and evaluated the impact of short-term MST on patients with COPD . METHODS Twelve patients with COPD ( FEV1 = 1.1 + /- 0.1 ) were pretested and then r and omly assigned to either an MST group ( N = 6 ) or a normal activity control group ( N = 6 ) . Within each MST training session ( three times per week for 8 wk ) , patients performed four sets of seated leg presses with a focus on the rate of force development at an intensity that only allowed the performance of five repetitions . RESULTS Patients who performed MST significantly improved their rate of force development ( 105 + /- 22.8 % ) , mechanical efficiency ( 32 + /- 7 % ) , and FEV1 ( 21.5 + /- 6.8 % ) , whereas these variables were unchanged in the controls . Neither group changed either peak oxygen consumption ( VO2peak ) or body mass . CONCLUSION In combination with the observed improvement in FEV1 , these data certainly support the therapeutic role for MST in the treatment of COPD BACKGROUND Training therapy with its manifold effects should be part of a modern and multi modular treatment of the COPD . Because of the specific symptoms ( e. g. muscle atrophy , dyspnea , low testosterone levels ) and the deconditioning of these patients , a resistance training might meet the dem and s of a COPD -exercise-therapy rather than an endurance training . The aim of this research project was to evaluate the efficiency of a hypertrophic maximal strength training on various COPD relevant parameters . METHODS 28 patients with moderate to severe COPD ( m12/f16 ) were r and omized and divided in a treatment and a control group . The patients in the treatment group underwent a resistance training ( hypertrophic maximal strength training ) for 12 weeks , initially two times , then three times a week . RESULTS Considering the results of the daily Peak-Flow-Measurement , there was no significant change in both groups , but a trend towards an improvement could be found in the treatment group . There was no difference in the change of FEV 1 . The performance on the ergo cycle showed a highly significant improvement ( p < 0.001 ) in the treatment group of 18.7 % ( 21.9 Watt ) . The results of the SGRQ showed a significant improvement ( p < 0.05 ) of the HRQL in the treatment group . A change of the HRQL in the control group was not found . CONCLUSIONS These data support the hypotheses that a short term high intensity strength training programme is suitable to improve performance measures of patients with moderate to severe COPD and it might also improve pulmonary function . The conclusion can be drawn , that this kind of resistance training can be prefered as COPD -specific training therapy and offers new treatment perspectives This study investigated the effects of heavy resistance training in elderly males with chronic obstructive pulmonary disease ( COPD ) . 18 Home-dwelling male patients ( age range : 65 - 80 years ) , with a mean forced expiratory volume in the first second ( FEV1 ) of 46 + /- 3.4 % of predicted value , were recruited . Baseline and post-training assessment s included : Cross-sectional area ( CSA ) of quadriceps assessed by MRI , isometric and isokinetic knee extension strength , isometric trunk strength , leg extension power , normal and maximal gait-speed on a 30 m track , stair climbing time , number of chair st and s in 30 s , lung function ( FEV1 ) and self-reported health . Subjects were r and omized to a resistance training group ( RE , n = 9 ) or a control group conducting breathing exercises ( CON , n = 9 ) . RE performed heavy progressive resistance training twice a week for 12 weeks . 6 RE and 7 CON completed the study . In RE the following improved ( P < 0.05 ) : Quadriceps CSA : 4 % , isometric knee extension strength : 14 % , isokinetic knee extension strength at 60 degrees /s . : 18 % , leg extension power : 19 % , maximal gait speed : 14 % , stair climbing time : 17 % , isometric trunk flexion : 5 % and self-reported health . In CON no changes were found . In conclusion , 12 weeks of heavy resistance training twice a week result ed in significant improvements in muscle size , knee extension strength , leg extension power , functional performance and self-reported health in elderly male COPD
Output:
| There were no significant differences in constant work rate endurance test results or in peak oxygen uptake between the two groups .
Resistance training was an effective approach to improve functional exercise capacity , endurance exercise capacity , and peak exercise capacity in COPD patients |
MS211461 | ***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 incidence of posttransplant diabetes mellitus ( PTDM ) was compared in three groups of renal transplant recipients : nondiabetic patients who had been r and omized between 1980 and 1983 to receive antilymphoblast globulin ( ALG ) , azathioprine ( AZA ) , and prednisone ( P ) ( group 1 ) or cyclosporine ( CsA ) plus prednisone ( group 2 ) . Group 3 consisted of a more recent ( 1984 - 85 ) cohort who were given a combination of azathioprine , cyclosporine , and prednisone ( + /- ALG ) . PTDM developed in 20 of 173 previously nondiabetic 18 - 55-year-old patients . Three of 47 patients ( 6.4 % ) in group 1 , 4 of 58 patients ( 6.9 % ) in group 2 , and 13 of 68 patients in group 3 ( 19.1 % ) developed PTDM . Thus in the two groups composing the concurrent prospect i ve r and omized trial ( groups 1 and 2 ) the incidence of PTDM did not differ . The subsequent patients who were given a combination of ALG , azathioprine , cyclosporine , and prednisone developed a significantly greater incidence of PTDM even though the total dose of cyclosporine and prednisone were lower than in groups 1 and 2 . PTDM usually occurred within two months of transplantation , and 11 of 17 patients who initially required insulin are still dependent upon exogenous insulin . The incidence of PTDM was not significantly affected by sex of the recipient , HLA-type , primary renal disease , rejection episodes , primary vs. secondary transplant , or prior splenectomy . The incidence of PTDM is greater in patients older than 45 ( 34.2 % vs. 5.2 % ) , and heavier than 70 kg ( 21.1 % vs. 5.1 % ) ; in recipients of cadaveric allografts ( 15.7 % vs. 4.6 % ) ; and in patients who were hospitalized for infections ( 22.4 % vs. 4.7 % ) . CsA levels tended to be higher in the group 2 and 3 patients who developed PTDM than in those who remained nondiabetic . One-year actuarial patient survival in those with PTDM was 83.3 % vs. 98 % ( P less than .01 ) in the nondiabetic and graft survival was 77.1 % vs. 87.1 % ( NS ) . The combination of Minnesota ALG , azathioprine , cyclosporine , and prednisone appears to predispose older , heavier recipients of cadaver allografts to the development of PTDM . The risk of PTDM must be weighed against the more usual results of improved patient and graft survival using this combination of immunosuppression BACKGROUND The addition of induction therapy with antilymphocytic antibodies to cyclosporine ( CsA ) based immunosuppression , has reduced acute rejection incidence and improved short-term survivals , but has not had well-established effects on long-term renal transplant survival . PATIENTS We analyzed the long-term allograft outcome of patients included in a prospect i ve r and omized clinical study conducted in our center 15 years ago by comparing two strategies : ( A ) horse antilymphoblast globulin ( ALG ) given at 10 mg/kg on alternate days to a maximum of 6 doses with low-dose CsA started at 8 mg/kg per day and prednisone at 0.25 mg/kg per day , versus ( B ) CsA started at 15 mg/kg per day and prednisone at 0.5 mg/kg per day . Diabetic and highly sensitized patients ( PRA > 70 % ) were excluded from the study . RESULTS The characteristics of the 50 patients enrolled in each group were not different . Although patient survival was not different ( 88 % in group A vs 77 % in group B ) , recipients treated with ALG showed a lower incidence of acute rejection episodes ( 20 % vs 44 % , P = .01 ) and better death-censored renal allograft survival ( 57 % vs 41 % , P = .03 ) . Among rejection-free patients , graft survival was 15 % higher in group A ( 60 % vs 45 % , P = .12 ) . Multivariate Cox regression analysis showed that an acute rejection episode ( relative risk [ RR ] : 2.44 , 95 % confidence interval [ CI ] 1.36 - 4.39 ; P = .0029 ) rather than ALG immunosuppression ( RR 0.74 , 95 % CI 0.41 - 1.33 ; P = NS ) was an independent predictor of death-censored graft survival . CONCLUSIONS In summary , we confirmed that concomitant induction therapy with ALG , CsA , and steroids improves long-term renal allograft survival Background . New trends in immunosuppression in clinical transplantation include the use of antibody induction agents in protocol s that emphasize reduction or avoidance of steroids and calcineurin inhibitors . Methods . In a r and omized trial using three different antibody induction agents in 90 first renal transplant recipients from cadaver donors , group A received Thymoglobulin , group B received Alemtuzumab , and group C received Daclizumab . Maintenance immunosuppression included tacrolimus and mycophenolate in all three arms , and methylprednisolone in groups A and C only ( st and ard clinical institutional practice ) . The targeted trough level of tacrolimus was between 8 and 10 ng/mL for groups A and C , respectively , with a targeted mycophenolate dose of 1 g twice daily . However , in group B , the target tacrolimus trough level was 4 to 7 ng/mL to reduce long-term nephrotoxicity , with 500 mg twice-daily doses of mycophenolate , without steroid maintenance . Results . In this 15-month median postoperative interval report , there were no notable differences in demographics and patient and graft survivals . Acute rejection rates at 1 year were equivalent , that is , 5 of 30 in all three groups ( 16.6 % ) . In group B , there was slightly lower renal function at 1 month , but no difference at 1 year . There was also significantly more leukopenia , but a greater percentage of T-regulatory cells and number of Fox-P3 mRNA copies by flow cytometry and semiquantitative polymerase chain reaction analysis , respectively , in group B. Conclusions . This preliminary analysis indicates that 80 % of the patients in group B remained steroid-free 1 year postoperatively , with lower tacrolimus trough levels and no difference in other adverse events Background Prevention of rejection after renal transplantation requires treatment with immunosuppressive drugs . Data on their in vivo effects on T- and B-cell phenotype and function are limited . Methods In a r and omized double-blind placebo-controlled study to prevent renal allograft rejection , patients were treated with tacrolimus , mycophenolate mofetil ( MMF ) , steroids , and a single dose of rituximab or placebo during transplant surgery . In a subset of patients , we analyzed the number and phenotype of peripheral T and B cells by multiparameter flow cytometry before transplantation , and at 3 , 6 , 12 , and 24 months after transplantation . Results In patients treated with tacrolimus/MMF/steroids the proportion of central memory CD4 + and CD8 + T cells was higher at 3 months post-transplant compared to pre-transplant levels . In addition , the ratio between the percentage of central memory CD4 + and CD4 + regulatory T cells was significantly higher up to 24 months post-transplant compared to pre-transplant levels . Interestingly , treatment with tacrolimus/MMF/steroids result ed in a shift toward a more memory-like B-cell phenotype post-transplant . Addition of a single dose of rituximab result ed in a long-lasting B-cell depletion . At 12 months post-transplant , the small fraction of repopulated B cells consisted of a high percentage of transitional B cells . Rituximab treatment had no effect on the T-cell phenotype and function post-transplant . Conclusions Renal transplant recipients treated with tacrolimus/MMF/steroids show an altered memory T and B-cell compartment post-transplant . Additional B-cell depletion by rituximab leads to a relative increase of transitional and memory-like B cells , without affecting T-cell phenotype and function . Trial Registration Clinical Trials.gov In renal transplantation , IL-17 production by T-cells might be dependent on the presence of B-cells . Therefore , the effect of in vivo B-cell depletion on ex-vivo IL-17 production was investigated . Twenty patients undergoing living-donor renal transplantation were recruited from a larger cohort of patients participating in a r and omized , double-blind trial . All patients were allocated to a single intra-operative dose of either placebo or rituximab ( 375 mg/m(2 ) ) added to the st and ard immunosuppressive therapy . Blood was collected at baseline , at one day , and at one month after surgery . The healthy kidney donors also gave blood at baseline . Peripheral blood mononuclear cells were stimulated ex-vivo in different manners ( heat killed C and ida albicans yeast , heat killed Staphylococcus aureus , or αCD3αCD28 coated beads ) , to address the role of B-cells in ex-vivo cytokine responses . The concentration of monocyte- and T-cell-derived cytokines ( IL-1β , IL-6 , TNF-α , IFN-γ , IL-17 and IL-22 ) was measured in supernatants . Of the 20 recruited patients , 13 received treatment with rituximab and 7 received placebo . In all patients , IL-17 was produced by CD4-positive , γδTCR-negative cells . After stimulation , there was no difference between patients and healthy controls in ex-vivo production of IL-17 or other cytokines . In all patients there was a general decrease of monocyte- and T-cell-derived cytokines after transplantation , except for IL-17 . There was no difference between patients who received rituximab and patients who received placebo . A single dose of rituximab treatment added to st and ard immunosuppressive therapy in renal transplant patients did not influence the production of IL-17 or other monocyte- or T-cell derived cytokines after ex-vivo stimulation UNLABELLED The use of the antilymphoblast globulin ( ALG ) or OKT3 associated with cyclosporine ( CyA ) and steroids has been useful in kidney cadaveric transplantation . 101 patients who received their first cadaveric renal transplant were r and omized according to the immunosuppression used . Group A ( n = 53 ) : horse ALG 15 mg/kg just before transplant surgery ; ALG 12 mg/kg on the first day after transplant followed by 4 doses of 10 mg/kg on alternate days ; Cya p.o 8 mg/kg/d ; prednisone 0.25 mg/kg/d . Group B ( n = 48 ) : OKT3 5 mg just before transplant followed by 4 doses of 5 mg/d . ; CyA and prednisone were administered using the same schedule as group A. RESULTS the incidence of rejection during the first 3 months was : group A : 13 percent , group B : 17 percent ( NS ) . The probability of being free of acute rejection ( Kaplan-Meier ) 24 months after transplant was 89 percent in group A and 79 percent in group B ( NS ) . The day of onset of the first acute rejection episode was 25 + /- 20 days after transplant in group A , and 17 + /- 10 day in group B ( NS ) . Incidence of tubular necrosis : group A 21 percent , group B 19 percent ( NS ) Rabbit antithymocyte globulin ( rATG ; Thymoglobulin ( ® ) ) is currently used to prevent acute rejection in kidney transplantation . The dose and regimen of rATG have not been optimized . Moreover , the impact of different treatment regimens on T-cell phenotype reconstitution remains unknown . We conducted a prospect i ve r and omized study of 17 renal transplant patients to determine the pharmacokinetics of total and active ( bound to human cells ) rATG and T-cell phenotype reconstitution after rATG administration . Patients received rATG at a total dose of 6mg/kg , administered either as 1.5mg/kg/day on days 0 - 3 ( Group 1 , n=8 ) or 3mg/kg on days 0 and 3 ( Group 2 , n=9 ) . All patients received tacrolimus , mycophenolate mofetil and steroids . Blood sample s were assayed for total rATG by enzyme linked immunosorbent assay and active rATG by flow cytometry . Maximum concentrations and terminal half-lives were similar between the two groups but at month 3 Group 1 had significantly lower values for total rATG ( concentration was 6.2±1.1μg/mL versus 10.2±2.9μg/mL in Group 2 , p=0.027 ) and total rATG dose-normalized A
Output:
| The effect of alemtuzumab with steroid minimisation on NODAT was uncertain , compared to ATG with steroid maintenance .
Treatment effects were uncertain for NODAT , thrombocytopenia , and malignancy or PTLD.Rituximab had uncertain effects on death , graft loss , acute rejection and all other adverse outcomes compared to placebo .
AUTHORS ' CONCLUSIONS ATG reduces acute rejection but has uncertain effects on death , graft survival , malignancy and NODAT , and increases CMV infection , thrombocytopenia and leucopenia .
Eleven patients would require treatment with alemtuzumab to prevent 1 having rejection , assuming a 21 % rejection risk with ATG.Triple maintenance without induction therapy compared to alemtuzumab combined with ESW had similar rates of acute rejection but adverse effects including NODAT were poorly documented .
Overall , ATG and alemtuzumab decrease acute rejection at a cost of increased CMV disease while patient-centred outcomes ( reduced death or lower toxicity ) do not appear to be improved |
MS211462 | ***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 exp and ed previous NIOSH-IRS research examining the effects of rest breaks and stretching exercises on symptoms and performance in data -entry workers . METHODS All workers spent 4 weeks with conventional breaks ( two 15 min breaks per day ) and 4 weeks with supplementary breaks ( two 15 min breaks plus four 5 min breaks per day ) . One-half were assigned at r and om to a group instructed to perform brief stretching exercises during breaks . The remainder comprised the " no stretching " ( control ) group . RESULTS 51 workers ( stretch group n = 21 ; no stretch group n = 30 ) completed the study symptom question naires . Discomfort and eyestrain were significantly lower with supplementary breaks , and supplementary breaks attenuated accumulation of discomfort and eyestrain during work sessions . Data -entry speed was significantly faster with supplementary breaks so that work output was maintained , despite replacing 20 min of work time with break time . In the stretch group , workers reported stretching during only 25 % of conventional breaks and 39 % of supplementary breaks , and no significant effects of stretching on discomfort or performance were observed . CONCLUSIONS These results provide further converging evidence that supplementary breaks reliably minimize discomfort and eyestrain without impairing productivity . Low compliance in performing stretches prevented valid assessment of stretching effects . Further research on stretching exercises and exercise compliance is warranted Objective : To investigate the effect of two contrasting physical activity worksite interventions versus a reference intervention ( REF ) on various health outcomes . Methods : A 1-year r and omized controlled trial was conducted with specific resistance training ( SRT ) , all-round physical exercise ( APE ) , and REF . Results : SRT and APE compared with REF showed significant reductions in systolic blood pressure ( ∼6 mm Hg ) , body fat percentage ( ∼2.2 body fat% ) , as well as shoulder and back pain ( ∼30 % reduction in duration ) . Muscle strength ( APE and SRT ) and maximal oxygen uptake ( APE ) increased approximately 10 % . Conclusions : Worksite intervention with both SRT as well as APE is recommended , since these activities compared with REF result ed in clinical ly relevant reductions of cardiovascular and metabolic syndrome-related risk factors as well as musculoskeletal pain symptoms , in combination with minor increases in physical capacity INTRODUCTION Office employees are exposed to hazardous levels of sedentary work . Interventions that integrate health promotion and health protection elements are needed to advance the health of sedentary workers . This study tested an integrated intervention on occupational sedentary/physical activity behaviors , cardiometabolic disease biomarkers , musculoskeletal discomfort , and work productivity . DESIGN Two-group , RCT . Data were collected between January and August 2014 . SETTING / PARTICIPANTS Overweight/obese adults working in sedentary desk jobs were r and omized to : ( 1 ) a health protection-only group ( HPO , n=27 ) ; or ( 2 ) an integrated health protection/health promotion group ( HP/HP , n=27 ) . INTERVENTION HPO participants received an ergonomic workstation optimization intervention and three e-mails/week promoting rest breaks and posture variation . HP/HP participants received the HPO intervention plus access to a seated activity permissive workstation . MAIN OUTCOME MEASURES Occupational sedentary and physical activity behaviors ( primary outcomes ) , cardiometabolic health outcomes , musculoskeletal discomfort , and work productivity ( secondary outcomes ) were measured at baseline and post-intervention ( 16 weeks ) . RESULTS The HP/HP group increased occupational light intensity physical activity over the HPO group and used the activity permissive workstations 50 minutes/work day . Significant associations were observed between activity permissive workstation adherence and improvements in several cardiometabolic biomarkers ( weight , total fat mass , resting heart rate , body fat percentage ) and work productivity outcomes ( concentration at work , days missed because of health problems ) . CONCLUSIONS The HP/HP group increased occupational physical activity and greater activity permissive workstation adherence was associated with improved health and work productivity outcomes . These findings are important for employers interested in advancing the well-being of sedentary office workers . TRIAL REGISTRATION This study is registered at www . clinical trials.gov NCT02071420 Objective : To investigate how worksite health interventions involving a 2.5-hour reduction of weekly working hours with ( PE ) or without ( RWH ) m and atory physical exercise affects productivity . Methods : Six workplaces in dental health care were matched and r and omized to three conditions ( PE , RWH and referents ) . Employees ' ( N = 177 ) self-rated productivity and the workplaces ' production levels ( number of patients ) were examined longitudinally . Results : Number of treated patients increased in all conditions during the intervention year . While RWH showed the largest increase in this measure , PE showed significant increases in self-rated productivity , that is , increased quantity of work and work-ability and decreased sickness absence . Conclusions : A reduction in work hours may be used for health promotion activities with sustained or improved production levels , suggesting an increased productivity since the same , or higher , production level can be achieved with lesser re sources OBJECTIVE To provide guidance on how systematic review authors , guideline developers , and health technology assessment practitioners should approach the use of the risk of bias in nonr and omized studies of interventions ( ROBINS-I ) tool as a part of GRADE 's certainty rating process . STUDY DESIGN AND SETTING The study design and setting comprised iterative discussion s , testing in systematic review s , and presentation at GRADE working group meetings with feedback from the GRADE working group . RESULTS We describe where to start the initial assessment of a body of evidence with the use of ROBINS-I and where one would anticipate the final rating would end up . The GRADE accounted for issues that mitigate concerns about confounding and selection bias by introducing the upgrading domains : large effects , dose-effect relations , and when plausible residual confounders or other biases increase certainty . They will need to be considered in an assessment of a body of evidence when using ROBINS-I. CONCLUSIONS The use of ROBINS-I in GRADE assessment s may allow for a better comparison of evidence from r and omized controlled trials ( RCTs ) and nonr and omized studies ( NRSs ) because they are placed on a common metric for risk of bias . Challenges remain , including appropriate presentation of evidence from RCTs and NRSs for decision-making and how to optimally integrate RCTs and NRSs in an evidence assessment The aim was to determine the effect of one weekly hour of specific strength training within working hours , performed with the same total training volume but with different training frequencies and duration s , or with different levels of supervision , on compliance , muscle health and performance , behavior and work performance . In total , 573 office workers were cluster-r and omized to : 1 WS : one 60-min supervised session/week , 3 WS : three 20-min supervised sessions/week , 9 WS : nine 7-min supervised sessions/week , 3 MS : three 20-min sessions/week with minimal supervision , or REF : a reference group without training . Outcomes were diary-based compliance , total training volume , muscle performance and question naire-based health , behavior and work performance . Comparisons were made among the WS training groups and between 3 WS and 3 MS . If no difference , training groups were collapsed ( TG ) and compared with REF . Results demonstrated similar degrees of compliance , mean(range ) of 39(33 - 44)% , and total training volume , 13.266(11.977 - 15.096)kg . Musculoskeletal pain in neck and shoulders were reduced with approx . 50 % in TG , which was significant compared with REF . Only the training groups improved significantly their muscle strength 8(4 - 13)% and endurance 27(12 - 37)% , both being significant compared with REF . No change in workability , productivity or self-rated health was demonstrated . Secondary analysis showed exercise self-efficacy to be a significant predictor of compliance . Regardless of training schedule and supervision , similar degrees of compliance were shown together with reduced musculoskeletal pain and improved muscle performance . These findings provide evidence that a great degree of flexibility is legitimate for companies in planning future implementation of physical exercise programs at the workplace . Clinical Trials.gov , number NCT01027390 Background Imbalance between individual re sources and work dem and s can lead to musculoskeletal disorders and reduced work ability . The purpose of this study was to investigate the effect of workplace- versus home-based physical exercise on work ability among healthcare workers . Methods Two hundred female healthcare workers ( Age : 42.0 , BMI : 24.1 , work ability index [ WAI ] : 43.1 ) from 18 departments at three Danish hospitals participated ( Copenhagen , Denmark , Aug 2013—Jan 2014 ) . Participants were r and omly allocated at the cluster level to 10 weeks of : 1 ) workplace physical exercise ( WORK ) performed during working hours for 5x10 min per week and up to 5 group-based coaching sessions on motivation for regular physical exercise , or 2 ) home-based physical exercise ( HOME ) performed during leisure time for 5x10 min per week . Both groups received ergonomic counseling on patient h and ling and use of lifting aides . The main outcome measure was the change from baseline to 10-week follow-up in WAI . Results Significant group by time interaction was observed for WAI ( p < 0.05 ) . WAI at follow-up was 1.1 ( 0.3 to 1.8 ) higher in WORK compared with HOME corresponding to a small effect size ( Cohens’d = 0.24 ) . Within-group changes indicated that between-group differences were mainly caused by a reduction in WAI in HOME . Of the seven items of WAI , item 2 ( work ability in relation to the dem and s of the job ) and item 5 ( sickness absence during the past year ) were improved in WORK compared with HOME ( P < 0.05 ) . Conclusions Performing physical exercise together with colleagues at the workplace prevents deterioration of work ability among female healthcare workers . Trial registration number Clinical Trials.gov NCT01921764 . Registered 10 August 2013 Non-r and omised studies of the effects of interventions are critical to many areas of healthcare evaluation , but their results may be biased . It is therefore important to underst and and appraise their strengths and weaknesses . We developed ROBINS-I ( “ Risk Of Bias In Non-r and omised Studies - of Interventions ” ) , a new tool for evaluating risk of bias in estimates of the comparative effectiveness ( harm or benefit ) of interventions from studies that did not use r and omisation to allocate units ( individuals or clusters of individuals ) to comparison groups . The tool will be particularly useful to those undertaking systematic review s that include non-r and omised studies Background The workplace has been identified as a priority setting to positively influence individuals ’ dietary behaviours . However , a dearth of evidence exists regarding the costs of implementing and delivering workplace dietary interventions . This study aim ed to conduct a cost- analysis of workplace nutrition education and environmental dietary modification interventions from an employer ’s perspective . Methods Cost data were obtained from a workplace dietary intervention trial , the Food Choice at Work Study . Micro-costing methods estimated costs associated with implementing and delivering the interventions for 1 year in four multinational manufacturing workplaces in Cork , Irel and . The workplaces were allocated to one of the following groups : control , nutrition education alone , environmental dietary modification alone and nutrition education and environmental dietary modification combined . A total of 850 employees were recruited across the four workplaces . For comparison purpose s , total costs were st and ardised for 500 employees per workplace . Results The combined intervention reported the highest total costs of € 31,108 . The nutrition education intervention reported total costs of € 28,529 . Total costs for the environmental dietary modification intervention were € 3689 . Total costs for the control workplace were zero . The average annual cost per employee was ; combined intervention : € 62 , nutrition education : € 57 , environmental modification : € 7 and control : € 0 . Nutritionist ’s time was the main cost contributor across all interventions , ( ranging from 53 to 75 % of total costs ) . Conclusions Within multi-component interventions , the relative cost of implementing and delivering nutrition education elements is high compared to environmental modification strategies . A workplace environmental modification strategy added marginal additional cost , relative to the control . Findings will inform employers and public health policy-makers regarding the economic feasibility of implementing and scaling dietary interventions .Trial registration Current Controlled Trials : IS RCT N35108237 . Date of registration : The trial was retrospectively registered on 02/07/2013 Objective : This study was conducted to determine whether installation of sit-st and desks ( SSDs ) could lead to decreased sitting time during the workday among sedentary office workers . Methods : A r and omized cross-over trial was conducted from January to April , 2012 at a business in Minneapolis . 28 ( nine men , 26 full-time ) sedentary office workers took part in a 4 week intervention period which included the use of SSDs to gradually replace 50 % of sitting time with st and ing during the workday . Physical activity was the primary outcome . Mood , energy level , fatigue , appetite , dietary intake , and productivity were explored as secondary outcomes . Results : The intervention reduced sitting time at work by 21 % ( 95 % CI 18%–25 % ) and sedentary time
Output:
| The scientific evidence shows that it is possible to influence work-related outcomes , especially absenteeism , positively through health promotion efforts that include components aim ed at the workplace ’s physical work environment and organizational structure . |
MS211463 | ***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 Few studies have investigated prognostic factors for patients with sciatica , especially for patients treated without surgery . The aim of this study was to identify factors associated with non-success after 1 and 2 years of follow-up and to test the prognostic value of surgical treatment for sciatica . Methods The study was a prospect i ve multicentre observational study including 466 patients with sciatica and lumbar disc herniation . Potential prognostic factors were sociodemographic characteristics , back pain history , kinesiophobia , emotional distress , pain , comorbidity and clinical examination findings . Study participation did not alter treatment considerations for the patients in the clinics . Patients reported on the question naires if surgery of the disc herniation had been performed . Uni- and multivariate logistic regression analyses were used to evaluate factors associated with non-success , defined as Maine – Seattle Back Question naire score of ≥5 ( 0–12 ) ( primary outcome ) and Sciatica Bothersomeness Index ≥7 ( 0–24 ) ( secondary outcome ) . Results Rates of non-success were at 1 and 2 years 44 % and 39 % for the main outcome and 47 % and 42 % for the secondary outcome . Approximately 1/3 of the patients were treated surgically . For the main outcome variable , in the final multivariate model non-success at 1 year was significantly associated with being male ( OR 1.70 [ 95 % CI ; 1.06 − 2.73 ] ) , smoker ( 2.06 [ 1.31 − 3.25 ] ) , more back pain ( 1.0 [ 1.01 − 1.02 ] ) , more comorbid subjective health complaints ( 1.09 [ 1.03 − 1.15 ] ) , reduced tendon reflex ( 1.62 [ 1.03 − 2.56 ] ) , and not treated surgically ( 2.97 [ 1.75 − 5.04 ] ) . Further , factors significantly associated with non-success at 2 years were duration of back problems > ; 1 year ( 1.92 [ 1.11 − 3.32 ] ) , duration of sciatica > ; 3 months ( 2.30 [ 1.40 − 3.80 ] ) , more comorbid subjective health complaints ( 1.10 [ 1.03 − 1.17 ] ) and kinesiophobia ( 1.04 [ 1.00 − 1.08 ] ) . For the secondary outcome variable , in the final multivariate model , more comorbid subjective health complaints , more back pain , muscular weakness at clinical examination , and not treated surgically , were independent prognostic factors for non-success at both 1 and 2 years . Conclusions The results indicate that the prognosis for sciatica referred to secondary care is not that good and only slightly better after surgery and that comorbidity should be assessed in patients with sciatica . This calls for a broader assessment of patients with sciatica than the traditional clinical assessment in which mainly the physical symptoms and signs are investigated Most common human traits and diseases have a polygenic pattern of inheritance : DNA sequence variants at many genetic loci influence the phenotype . Genome-wide association ( GWA ) studies have identified more than 600 variants associated with human traits , but these typically explain small fractions of phenotypic variation , raising questions about the use of further studies . Here , using 183,727 individuals , we show that hundreds of genetic variants , in at least 180 loci , influence adult height , a highly heritable and classic polygenic trait . The large number of loci reveals patterns with important implication s for genetic studies of common human diseases and traits . First , the 180 loci are not r and om , but instead are enriched for genes that are connected in biological pathways ( P = 0.016 ) and that underlie skeletal growth defects ( P < 0.001 ) . Second , the likely causal gene is often located near the most strongly associated variant : in 13 of 21 loci containing a known skeletal growth gene , that gene was closest to the associated variant . Third , at least 19 loci have multiple independently associated variants , suggesting that allelic heterogeneity is a frequent feature of polygenic traits , that comprehensive explorations of already-discovered loci should discover additional variants and that an appreciable fraction of associated loci may have been identified . Fourth , associated variants are enriched for likely functional effects on genes , being over-represented among variants that alter amino-acid structure of proteins and expression levels of nearby genes . Our data explain approximately 10 % of the phenotypic variation in height , and we estimate that unidentified common variants of similar effect sizes would increase this figure to approximately 16 % of phenotypic variation ( approximately 20 % of heritable variation ) . Although additional approaches are needed to dissect the genetic architecture of polygenic human traits fully , our findings indicate that GWA studies can identify large numbers of loci that implicate biologically relevant genes and pathways The endogenous opioid system is involved in stress responses , in the regulation of the experience of pain , and in the action of analgesic opiate drugs . We examined the function of the opioid system and μ-opioid receptors in the brains of healthy human subjects undergoing sustained pain . Sustained pain induced the regional release of endogenous opioids interacting with μ-opioid receptors in a number of cortical and subcortical brain regions . The activation of the μ-opioid receptor system was associated with reductions in the sensory and affective ratings of the pain experience , with distinct neuroanatomical involvements . These data demonstrate the central role of the μ-opioid receptors and their endogenous lig and s in the regulation of sensory and affective components of the pain experience Study Design . A prospect i ve analysis of patients with lumbar disc herniation ( LDH ) . Objectives . To determine the role of neuropeptides as a biochemical signature of pain states in patients with LDH . Summary of Background Data . Increases in the plasma level of neuropeptides have been reported in patients suffering from a variety of painful conditions . However , there is no such report on patients with LDH . Methods . From a total of 27 patients with a single-level LDH , blood sample s were collected before and 3 weeks after lumbar discectomy . Plasma levels of alpha calcitonin gene-related peptide ( CGRP ) , galanin , neuropeptide Y , and substance P were determined by using enzyme-linked immunosorbent assay . The association or correlation between preoperative concentration of plasma neuropeptides and gender , patients ’ age , and VAS were analyzed statistically . Also , the concentration of plasma neuropeptides was compared before and after lumbar discectomy . Results . Preoperative plasma levels of CGRP were correlated significantly with the extent of sciatica as determined by VAS . In addition , plasma levels of CGRP and galanin significantly decreased after lumbar discectomy in line with the disappearance of pain symptoms . Conclusions . These findings indicate the role of plasma CGRP and possibly galanin as a systemic neurochemical signature of pain states in patients with LDH Background Earlier observations show that development of persistent pain may be associated with the genetic variability in the gene encoding for the μ-opioid receptor 1 , the OPRM1 A118 G ( rs1799971 ) . The aim of this study was to investigate the association between OPRM1 genotype and subjective health complaints in patients with radicular pain and disc herniation . Methods A prospect i ve , 1-year observational study was conducted at a hospital back clinic , including 118 Caucasian patients with lumbar radicular pain and MRI confirmed disc herniation . Single nucleotide polymorphism genotyping regarding the OPRM1 A118 G was performed . The data of individuals with AA versus AG or GG were analysed separately by linear mixed models . The Subjective Health Complaints Inventory ( 0 - 81 ) including 27 common complaints experienced the previous month on a scale from not at all ( 0 ) to severe ( 3 ) was used as outcome . Pain , prior duration of leg pain , age , smoking status , and lumbar disc surgery were considered as covariates . Results In total 23 of 118 patients were carriers of the OPRM1 G-allele . All patients except female carriers of the G-allele reported a decrease in pain from baseline to 1 year . Female carriers of the G-allele reported significantly higher subjective health complaints score during the study time span than male carriers of the G-allele when controlling for pain and pain duration . Conclusion The present data indicate that , when controlling for pain intensity and duration , subjective health complaints are associated with a sex - OPRM1 A118 G polymorphism interaction in patients with radicular pain Study Design . Prospect i ve observational cohort . Objective . Correlate epidural inflammatory cytokines with the clinical response to epidural steroid injection in patients with lumbar nerve root irritation . Summary of Background Data . Some back pain syndromes are thought to be associated with activation of inflammatory pathways and others may be associated with primary mechanical derangements . Human studies providing detailed evidence for the primary inflammatory causation , which may be best treated with anti-inflammatory strategies , are lacking . There are currently no accurate diagnostic tests to predict the response to epidural steroid injection or surgical intervention in back pain and sciatica syndromes . Methods . Forty-seven consecutive patients with lumbar degenerative changes and low back and /or leg pain were prospect ively enrolled . An epidural lavage was performed , followed by injection of marcaine/depo-medrol . Subjects scored their pain before and 3 months after the procedure . The immunoreactivity of an array of cytokines was measured in lavage sample s and compared with clinical response to the therapeutic injection . Ten subjects underwent repeat epidural lavage sampling 3 months after the steroid injection . Results . Interferon gamma ( IFN&ggr ; ) was the most consistently detected cytokine . IFN&ggr;-immunoreactivity also highly correlated with reported reduction of pain 3-months after the epidural steroid injection . In subjects reporting significant pain relief ( > 50 % ) from the injection , mean [ IFN&ggr ; ] was significantly greater compared with patients experiencing no significant relief . The IFN&ggr;-immunoreactivity in repeat lavage sample s decreased to trace residual concentrations in patients who reported pain relief from the steroid injection . Conclusion . The presence of epidural IFN&ggr;-immunoreactivity corresponding to > 10 pg/mL predicted significant pain relief after epidural steroid injection with > 95 % accuracy . These results suggest that IFN&ggr ; may be part of a biochemical cascade triggering pain in sciatica ; IFN&ggr;-immunoreactivity may aid as a biomarker for predicting the response to steroid therapy and /or surgical intervention , and may serve as a future therapeutic target In this prospect i ve longitudinal study with a follow-up of 6 months , the course of serum concentration of C-reactive protein was measured by an ultrasensitive immunoassay in 31 patients with acute lumbosciatic pain and 41 patients with chronic low back pain . High-sensitive CRP ( hsCRP ) , pain and clinical function were assessed at ten fixed time-points during follow-up . The course of hsCRP values was assessed in relation to the course of pain and clinical function adjusting for possible confounding factors . At the beginning of the study , there were no statistically significant differences in mean hsCRP levels in patients with acute lumbosciatic pain ( 1.49mg/l ) compared to the levels obtained in patients with chronic low back pain ( 1.30mg/l ) and those in a control group from the general population ( 1.26mg/l ) . In patients with acute lumbosciatic pain , hsCRP declined significantly in the initial period of 3 weeks with a corresponding decrease in pain and improvement in function and clinical evaluation as assessed with the straight leg raising test ( SLR ) , whereas after this period , the course of the hsCRP did not correspond with the clinical parameters . In patients with chronic low back pain , hsCRP remained approximately constant throughout the whole period with no correlation with pain or function . As a conclusion , according to this study levels of hsCRP do not have a major clinical relevance when evaluating the long-term course of patients with acute lumbosciatic pain and chronic low back pain and therefore should not be taken into primary consideration when decisions on therapy are made AIMS We have shown in a cross-sectional setting that an IL6 haplotype ( GGGA ) is associated with intervertebral disc disease ( IDD ) characterized by sciatica . The aim of this study was to evaluate the prognostic role of the GGGA haplotype in IDD . METHODS DNA from 153 sciatica patients who participated in a r and omized controlled trial of periradicular infiltration was analysed for IL6 variations rs1800797 ( -596A > G ) , rs1800796 ( -572G > C ) , rs1800795 ( -174G > C ) , and rs13306435 ( + 15T > A ) . The patients recorded back and leg pain intensity and duration , disability by Oswestry Index and back-related sickness absence over a three-year follow-up . Repeated measures and univariate analysis of variance with adjustment for age , gender and physical work load were used in statistical analyses for the last two-years of the follow-up . RESULTS The prevalence of the GGGA haplotype was 9 % ( 14/153 ) . Subjects with the GGGA haplotype did not differ from those without the haplotype with respect to pain intensity , or disability score , but days with back and leg pain and days on sick leave were significantly higher among subjects with the IL6 haplotype after adjustment for occupation ( p=0.006 , 0.001 and 0.002
Output:
| Conclusion The present results indicate that several genetic factors and biomarkers may predict slow recovery in LRP . |
MS211464 | ***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: Abstract The effects of the powdered rhizome of Zingiber officinale on the symptoms of motion sickness were compared with those of dimenhydrinate and placebo in 36 undergraduate men and women who reported very high susceptibility to motion sickness . Motion sickness was induced by placing the blindfolded subject in a tilted rotating chair . Measurements of perceived degree of gastrointestinal distress were reported every 15 s for up to 6 minutes by means of psychophysical methods . Z. officinale was superior to dimenhydrinate in reducing motion sickness In a placebo-controlled study the effect of ginger and fenugreek was examined on blood lipids , blood sugar , platelet aggregation , fibrinogen and fibrinolytic activity . The subjects included in this study were healthy individuals , patients with coronary artery disease ( CAD ) , and patients with non-insulin-dependent diabetes mellitus ( NIDDM ) who either had CAD or were without CAD . In patients with CAD powdered ginger administered in a dose of 4 g daily for 3 months did not affect ADP- and epinephrine-induced platelet aggregation . Also , no change in the fibrinolytic activity and fibrinogen level was observed . However , a single dose of 10 g powdered ginger administered to CAD patients produced a significant reduction in platelet aggregation induced by the two agonists . Ginger did not affect the blood lipids and blood sugar . Fenugreek given in a dose of 2.5 g twice daily for 3 months to healthy individuals did not affect the blood lipids and blood sugar ( fasting and post pr and ial ) . However , administered in the same daily dose for the same duration to CAD patients also with NIDDM , fenugreek decreased significantly the blood lipids ( total cholesterol and triglycerides ) without affecting the HDL-c . When administered in the same daily dose to NIDDM ( non-CAD ) patients ( mild cases ) , fenugreek reduced significantly the blood sugar ( fasting and post pr and ial ) . In severe NIDDM cases , blood sugar ( both fasting and post pr and ial ) was only slightly reduced . The changes were not significant . Fenugreek administration did not affect platelet aggregation , fibrinolytic activity and fibrinogen OBJECTIVE Evaluation of the effect of a ginger extract ( Zintona EC ) on patients suffering from gonarthritis . MATERIAL AND METHODS Twenty-nine patients ( 6 men and 23 women ) with symptomatic gonarthritis ( ACR criteria ) , in the age range 42 - 85 years , were included after r and omization in a double blind , placebo controlled , crossover study of 6 months ' duration . The treatment group was given a ginger extract ( 250 mg of Zingiberis Rhizoma per capsule , qid ) , while the placebo group received the same number of identical looking capsules per day . The crossover occurred after 3 months of therapy . Results were evaluated by a 100 mm visual analog scale ( VAS ) of pain on movement and of h and icap . RESULTS Eight patients dropped out because of inefficacy , three from group 1 ( ginger extract first ) and five from group 2 ( placebo first ) . One patient from group 1 and one from group 2 dropped out because of heartburn ( while they were on ginger extract ) . Twenty patients completed the study period of 24 weeks and 19 that of 48 weeks follow-up . By the end of 24 weeks there was a highly statistically significant difference between the VAS of pain and h and icap of the two groups ( P<0.001 ) . However , at crossover both groups showed a statistically significant decrease in VAS of pain on movement and of h and icap , but the differences between the groups did not reach statistical significance . CONCLUSIONS Zintona EC was as effective as placebo during the first 3 months of the study , but at the end of 6 months , 3 months after crossover , the ginger extract group showed a significant superiority over the placebo group Objective To determine the effectiveness of ginger for the treatment of nausea and vomiting of pregnancy . Methods Women with nausea and vomiting of pregnancy , who first attended an antenatal clinic at or before 17 weeks ' gestation , were invited to participate in the study . During a 5-month period , 70 eligible women gave consent and were r and omized in a double-masked design to receive either oral ginger 1 g per day or an identical placebo for 4 days . Subjects grade d the severity of their nausea using visual analog scales and recorded the number of vomiting episodes in the previous 24 hours before treatment , and again during 4 consecutive days while taking treatment . At a follow-up visit 7 days later , five-item Likert scales were used to assess the severity of their symptoms . Results All participants except three in the placebo group remained in the study . The visual analog scores of posttherapy minus baseline nausea decreased significantly in the ginger group ( 2.1 ± 1.9 ) compared with the placebo group ( 0.9 ± 2.2 , P = .014 ) . The number of vomiting episodes also decreased significantly in the ginger group ( 1.4 ± 1.3 ) compared with the placebo group ( 0.3 ± 1.1 , P < .001 ) . Likert scales showed that 28 of 32 in the ginger group had improvement in nausea symptoms compared with 10 of 35 in the placebo group ( P < .001 ) . No adverse effect of ginger on pregnancy outcome was detected . Conclusion Ginger is effective for relieving the severity of nausea and vomiting of pregnancy OBJECTIVE Alternative medicine is used extensively by patients with chronic pain due to e.g. , osteoarthritis . Only few of these drugs have be tested in a controlled setting and the present study was undertaken to examine the effect of ginger extract , one of the most popular herbal medications . DESIGN Ginger extract was compared to placebo and Ibuprofen in patients with osteoarthritis of the hip or knee in a controlled , double blind , double dummy , cross-over study with a wash-out period of one week followed by three treatment periods in a r and omized sequence , each of three weeks duration . Acetaminophen was used as rescue medication throughout the study . The study was conducted in accordance with Good Clinical Practice ( European Guideline for GCP ) . RESULTS A ranking of efficacy of the three treatment periods : Ibuprofen > ginger extract > placebo was found for visual analogue scale of pain ( Friedman test : 24.65 , P < 0.00001 ) and the Lequesne-index ( Friedman test : 20.76 , P < 0.00005 ) . In the cross-over study , no significant difference between placebo and ginger extract could be demonstrated ( Siegel-Castellan test ) , while explorative tests of differences in the first treatment period showed a better effect of both Ibuprofen and ginger extract than placebo ( Chi-square , P < 0.05 ) . There were no serious adverse events reported during the periods with active medications . CONCLUSION In the present study a statistically significant effect of ginger extract could only be demonstrated by explorative statistical methods in the first period of treatment before cross-over , while a significant difference was not observed in the study as a whole Objective : To investigate the effect of a ginger extract ( EV.EXT35 ) on the symptoms of morning sickness Ginger has long been used as an alternative medication to prevent motion sickness . The mechanism of its action , however , is unknown . We hypothesize that ginger ameliorates the nausea associated with motion sickness by preventing the development of gastric dysrhythmias and the elevation of plasma vasopressin . Thirteen volunteers with a history of motion sickness underwent circular vection , during which nausea ( scored 0 - 3 , i.e. , none to severe ) , electrogastrographic recordings , and plasma vasopressin levels were assessed with or without ginger pretreatment in a crossover- design , double-blind , r and omized placebo-controlled study . Circular vection induced a maximal nausea score of 2.5 + /- 0.2 and increased tachygastric activity and plasma vasopressin . Pretreatment with ginger ( 1,000 and 2,000 mg ) reduced the nausea , tachygastria , and plasma vasopressin . Ginger also prolonged the latency before nausea onset and shortened the recovery time after vection cessation . Intravenous vasopressin infusion at 0.1 and 0.2 U/min induced nausea and increased bradygastric activity ; ginger pretreatment ( 2,000 mg ) affected neither . Ginger effectively reduces nausea , tachygastric activity , and vasopressin release induced by circular vection . In this manner , ginger may act as a novel agent in the prevention and treatment of motion sickness Acute hyperglycemia evokes gastric slow wave dysrhythmias via endogenous prostagl and in generation . Ginger exhibits slow wave antiarrhythmic effects in other models , but its actions on hyperglycemia-evoked gastric dysrhythmias are unexplored . We hypothesized that ginger prevents disruption of slow wave rhythm by acute hyperglycemia via inhibition of prostagl and in production but not its actions . Twenty-two healthy humans underwent fasting electrogastrography during hyperglycemic clamping to 250 to 290 mg/dl after double-blind placebo or ginger root ( 1 g ) . Responses were compared with the prostagl and in E1 analog misoprostol ( 400 μg ) . Dominant frequencies ( DF ) and the percentage of recording times in the bradygastric [ 0.5–2 cycles/min ( cpm ) ] , normal ( 2–4 cpm ) , and tachygastric ( 4–9 cpm ) frequency ranges were analyzed . After placebo , hyperglycemia reduced normal 2 to 4 cpm activity from 94.4 ± 2.6 to 66.0 ± 10.4 % , increased the DF from 2.96 ± 0.04 to 4.09 ± 0.45 cpm , and increased tachygastria from 2.0 ± 1.4 to 29.3 ± 10.7 % ( P < 0.05 ) . Hyperglycemia effects on normal activity ( 77.3 ± 8.3 % ) , DF ( 3.46 ± 0.37 cpm ) , and tachygastria ( 15.6 ± 8.6 % ) were significantly reduced by ginger ( P < 0.05 ) . Misoprostol evoked decreases in normal activity from 95.4 ± 2.0 to 81.7 ± 3.0 % and increases in tachygastria from 3.1 ± 1.6 to 11.2 ± 2.4 % ( P < 0.05 ) . However , ginger did not correct these abnormalities versus placebo ( P = N.S. ) . In conclusion , acute hyperglycemia evokes gastric slow wave dysrhythmias that are prevented by ginger root . Conversely , the compound has no effect on dysrhythmias elicited by a prostagl and in E1 analog , indicating that ginger likely acts to blunt production of prostagl and ins rather than inhibiting their action . These findings suggest novel mechanisms for the traditional Chinese herbal remedy ginger The effectiveness of ginger ( Zingiber officinale ) as an antiemetic agent was compared with placebo and metoclopramide in 60 women who had major gynaecological surgery in a double‐blind , r and omised study . There were statistically significantly fewer recorded incidences of nausea in the group that received ginger root compared with placebo ( p < 0.05 ) . The number of incidences of nausea in the groups that received either ginger root or metoclopramide were similar . The administration of antiemetic after operation was significantly greater in the placebo group compared to the other two groups ( p < 0.05 ) OBJECTIVE To compare the efficacy of ginger to vitamin B6 in the treatment of nausea and vomiting of pregnancy . STUDY DESIGN A r and omized double-blind controlled trial . SETTING The Department of Obstetrics and Gynecology , Bangkok Metropolitan Administration Medical College and Vajira Hospital . SUBJECTS Women with nausea and vomiting of pregnancy at or before 16 weeks of gestation , who attended the antenatal care clinic . The subjects requested anti-emetics , had no medical complications , non-hospitalized and were able to attend a one week follow-up visit . From November , 1999 to November 2000 , 138 women participated and gave consent for the study . METHOD The subjects were r and omly allocated into two groups to take either 500 mg of ginger orally or an identical 10 mg of vitamin B6 one capsule three times daily for three days . Subjects grade d the severity of their nausea using visual analogue scales before treatment and recorded the number of vomiting episodes in the previous 24 hours and again during three consecutive days of treatment . MAIN OUTCOME MEASURES The change of nausea scores and the number of vomiting episodes during three days of treatment . RESULTS The 64 subjects in each group remained in the study . The demographic data were comparable in both groups . The ginger and vitamin B6 significantly reduced the nausea scores from 5.0 ( SD , 1.99 ) to 3.6 ( SD , 2.48 ) and 5.3 ( SD , 2.08 ) to 3.3 ( SD , 2.07 ) respectively , with p < 0.001 . The mean score change after treatment with ginger was 1.4 ( 2.21 ) , less than with vitamin B6 , which
Output:
| The observational study retrieved and RCTs ( including follow-up periods ) showed the absence of significant side effects or adverse effects on pregnancy outcomes .
There were no spontaneous or case reports of adverse events during ginger treatment in pregnancy .
: Ginger may be an effective treatment for nausea and vomiting in pregnancy . |
MS211465 | ***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 incremental cost and cost-effectiveness of continuous and discontinuous regimens of bevacizumab ( Avastin ) and ranibizumab ( Lucentis ) for neovascular age-related macular degeneration ( nAMD ) from a UK National Health Service ( NHS ) perspective . Design A within-trial cost-utility analysis with a 2-year time horizon , based on a multicentre factorial , non-inferiority r and omised controlled trial . Setting 23 hospital ophthalmology clinics . Participants 610 patients aged ≥50 years with untreated nAMD in the study eye . Interventions 0.5 mg ranibizumab or 1.25 mg bevacizumab given continuously ( monthly ) or discontinuously ( as-needed ) for 2 years . Main outcome measures Quality -adjusted life-years ( QALYs ) . Results Total 2-year costs ranged from £ 3002/patient ( $ 4700 ; 95 % CI £ 2601 to £ 3403 ) for discontinuous bevacizumab to £ 18 590/patient ( $ 29 106 ; 95 % CI £ 18 258 to £ 18 922 ) for continuous ranibizumab . Ranibizumab was significantly more costly than bevacizumab for both continuous ( + £ 14 989/patient ( $ 23 468 ) ; 95 % CI £ 14 522 to £ 15 456 ; p<0.001 ) and discontinuous treatment ( + £ 8498 ( $ 13 305 ) ; 95 % CI £ 7700 to £ 9295 ; p<0.001 ) , with negligible difference in QALYs . Continuous ranibizumab would only be cost-effective compared with continuous bevacizumab if the NHS were willing to pay £ 3.5 million ( $ 5.5 million ) per additional QALY gained . Patients receiving continuous bevacizumab accrued higher total costs ( + £ 599 ( $ 938 ) ; 95 % CI £ 91 to £ 1107 ; p=0.021 ) than those receiving discontinuous bevacizumab , but also accrued non-significantly more QALYs ( + 0.020 ; 95 % CI −0.032 to 0.071 ; p=0.452 ) . Continuous bevacizumab therefore cost £ 30 220 ( $ 47 316 ) per QALY gained versus discontinuous bevacizumab . However , bootstrapping demonstrated that if the NHS is willing to pay £ 20 000/QALY gained , there is a 37 % chance that continuous bevacizumab is cost-effective versus discontinuous bevacizumab . Conclusions Ranibizumab is not cost-effective compared with bevacizumab , being substantially more costly and producing little or no QALY gain . Discontinuous bevacizumab is likely to be the most cost-effective of the four treatment strategies evaluated in this UK trial , although there is a 37 % chance that continuous bevacizumab is cost-effective . Trial registration number IS RCT N92166560 Background : Due to the high prevalence of overweight and obesity there is a need to identify cost-effective approaches for weight loss in primary care and community setting s. Objective : We evaluated the cost effectiveness of two weight loss programmes of 1-year duration , either st and ard care ( SC ) as defined by national guidelines , or a commercial provider ( Weight Watchers ) ( CP ) . Design : This analysis was based on a r and omised controlled trial of 772 adults ( 87 % female ; age 47.4±12.9 years ; body mass index 31.4±2.6 kg m−2 ) recruited by health professionals in primary care in Australia , United Kingdom and Germany . Both a health sector and societal perspective were adopted to calculate the cost per kilogram of weight loss and the ICER , expressed as the cost per quality adjusted life year ( QALY ) . Results : The cost per kilogram of weight loss was USD122 , 90 and 180 for the CP in Australia , the United Kingdom and Germany , respectively . For SC the cost was USD138 , 151 and 133 , respectively . From a health-sector perspective , the ICER for the CP relative to SC was USD18 266 , 12 100 and 40 933 for Australia , the United Kingdom and Germany , respectively . Corresponding societal ICER figures were USD31 663 , 24 996 and 51 571 . Conclusion : The CP was a cost-effective approach from a health funder and societal perspective . Despite participants in the CP group attending two to three times more meetings than the SC group , the CP was still cost effective even including these added patient travel costs . This study indicates that it is cost effective for general practitioners ( GPs ) to refer overweight and obese patients to a CP , which may be better value than expending public funds on GP visits to manage this problem OBJECTIVE To evaluate the cost-effectiveness of a prize-based intervention as an addition to usual care for stimulant abusers . METHODS This cost-effectiveness analysis is based on a r and omized clinical trial implemented within the National Drug Abuse Treatment Clinical Trials Network . The trial was conducted at eight community-based outpatient psychosocial drug abuse treatment clinics . Four hundred and fifteen stimulant abusers were assigned to usual care ( N=206 ) or usual care plus abstinence-based incentives ( N=209 ) for 12 weeks . Participants r and omized to the incentive condition earned the chance to draw for prizes for su bmi tting substance negative sample s ; the number of draws earned increased with continuous abstinence time . Incremental cost-effectiveness ratios were estimated to compare prize-based incentives relative to usual care . The primary patient outcome was longest duration of confirmed stimulant abstinence ( LDA ) . Unit costs were obtained via surveys administered at the eight participating clinics . Re source utilizations and patient outcomes were obtained from the clinical trial . Acceptability curves are presented to illustrate the uncertainty due to the sample and to provide policy relevant information . RESULTS The incremental cost to lengthen the LDA by 1 week was 258 US dollars ( 95 % confidence interval , 191 - 401 US dollars ) . Sensitivity analyses on several key parameters show that this value ranges from 163 to 269 US dollars . CONCLUSIONS Compared with the usual care group , the incentive group had significantly longer LDAs and significantly higher costs Objectives : To determine whether , from a healthcare perspective , a specific occupational health intervention is cost effective in reducing sickness absence when compared with usual care in occupational health in workers with high risk of sickness absence . Methods : Economic evaluation alongside a r and omised controlled trial . 418 workers with high risk of sickness absence from one corporation were r and omised to intervention ( n = 209 ) or to usual care ( n = 209 ) . The subjects in the intervention group were invited to occupational health service for a consultation . The intervention included , if appropriate , a referral to specialist treatment . Register data of sickness absence were available for 384 subjects and question naire data on healthcare costs from 272 subjects . Missing direct total cost data were imputed using a two-part regression model . Primary outcome measures were sickness absence days and direct healthcare costs up to 12 months after r and omisation . Cost effectiveness ( CE ) was expressed as an incremental CE ratio , CE plane and CE acceptability curve with both available direct total cost data and missing total cost data imputed . Results : After one year , the mean of sickness absence was 30 days in the usual care group ( n = 192 ) and 11 days less ( 95 % CI 1 to 20 days ) in the intervention group ( n = 192 ) . Among the employees with available cost data , the mean days of sickness absence were 22 and 24 , and the mean total cost € 974 and € 1049 in the intervention group ( n = 134 ) and in the usual care group ( n = 138 ) , respectively . The intervention turned out to be dominant — both cost saving and more effective than usual occupational health care . The saving was € 43 per sickness absence day avoided with available direct total cost data , and € 17 with missing total cost data imputed . Conclusions : One year follow-up data show that occupational health intervention for workers with high risk of sickness absence is a cost effective use of healthcare re sources BACKGROUND Little is known about the cost-effectiveness of preventing mental disorders . AIMS To study the cost-effectiveness of care as usual plus minimal contact psychotherapy relative to usual care alone in preventing depressive disorder . METHOD An economic evaluation was conducted alongside a r and omised clinical trial . Primary care patients with sub-threshold depression were assigned to minimal contact psychotherapy plus usual care ( n=107 ) or to usual care alone ( n=109 ) . RESULTS Primary care patients with sub-threshold depression benefited from minimal contact psychotherapy as it reduced the risk of developing a full-blown depressive disorder from 18 % to 12 % . In addition , this intervention had a 70 % probability of being more cost-effective than usual care alone . A sensitivity analysis indicated the robustness of these results . CONCLUSIONS Over 1 year adjunctive minimal contact psychotherapy improved outcomes and generated lower costs . This intervention is therefore superior to usual care alone in terms of cost-effectiveness Purpose of the study : to examine the costs and cost-effectiveness of ‘ second-generation ’ telecare , in addition to st and ard support and care that could include ‘ first-generation ’ forms of telecare , compared with st and ard support and care that could include ‘ first-generation ’ forms of telecare . Design and methods : a pragmatic cluster-r and omised controlled trial with nested economic evaluation . A total of 2,600 people with social care needs participated in a trial of community-based telecare in three English local authority areas . In the Whole Systems Demonstrator Telecare Question naire Study , 550 participants were r and omised to intervention and 639 to control . Participants who were offered the telecare intervention received a package of equipment and monitoring services for 12 months , additional to their st and ard health and social care services . The control group received usual health and social care . Primary outcome measure : incremental cost per quality -adjusted life year ( QALY ) gained . The analyses took a health and social care perspective . Results : cost per additional QALY was £ 297,000 . Cost-effectiveness acceptability curves indicated that the probability of cost-effectiveness at a willingness-to-pay of £ 30,000 per QALY gained was only 16 % . Sensitivity analyses combining variations in equipment price and support cost parameters yielded a cost-effectiveness ratio of £ 161,000 per QALY . Implication s : while QALY gain in the intervention group was similar to that for controls , social and health services costs were higher . Second-generation telecare did not appear to be a cost-effective addition to usual care , assuming a commonly accepted willingness to pay for QALYs . Trial registration number : IS RCT N 43002091 BACKGROUND Uncertainty exists regarding the best management of patients with degenerative tears of the rotator cuff . OBJECTIVE To evaluate the clinical effectiveness and cost-effectiveness of arthroscopic and open rotator cuff repair in patients aged ≥ 50 years with degenerative rotator cuff tendon tears . DESIGN Two parallel-group r and omised controlled trial . SETTING Nineteen teaching and district general hospitals in the UK . PARTICIPANTS Patients ( n = 273 ) aged ≥ 50 years with degenerative rotator cuff tendon tears . INTERVENTIONS Arthroscopic surgery and open rotator cuff repair , with surgeons using their usual and preferred method of arthroscopic or open repair . Follow-up was by telephone question naire at 2 and 8 weeks after surgery and by postal question naire at 8 , 12 and 24 months after r and omisation . MAIN OUTCOME MEASURES The Oxford Shoulder Score ( OSS ) at 24 months was the primary outcome measure . Magnetic resonance imaging evaluation of the shoulder was made at 12 months after surgery to assess the integrity of the repair . RESULTS The mean OSS improved from 26.3 [ st and ard deviation ( SD ) 8.2 ] at baseline to 41.7 ( SD 7.9 ) at 24 months for arthroscopic surgery and from 25.0 ( SD 8.0 ) at baseline to 41.5 ( SD 7.9 ) at 24 months for open surgery . When effect sizes are shown for the intervention , a negative sign indicates that an open procedure is favoured . For the intention-to-treat analysis , there was no statistical difference between the groups , the difference in OSS score at 24 months was -0.76 [ 95 % confidence interval ( CI ) -2.75 to 1.22 ; p = 0.452 ] and the CI excluded the predetermined clinical ly important difference in the OSS of 3 points . There was also no statistical difference when the groups were compared per protocol ( difference in OSS score -0.46 , 95 % CI -5.30 to 4.39 ; p = 0.854 ) . The question naire response rate was > 86 % . At 8 months , 77 % of participants reported that shoulder problems were much or slightly better , and at 24 months this increased to 85 % . There were no significant differences in mean cost between the arthroscopic group and the open repair group for any of the component re source -use categories , nor for
Output:
| Our review shows that missing data in within- RCT CEAs are still often inadequately h and led and the overall level of information provided to support the chosen methods is rarely satisfactory |
MS211466 | ***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: Acupuncture-like transcutaneous electrical nerve stimulation ( ALTENS ) was compared with a placebo treatment in altering acute electrical pain thresholds . Ten pain-free subjects underwent , on different days , an acclimatization session , an ALTENS treatment , and a placebo treatment in a cross-over design . Electrical sensation and pain thresholds were measured from the tip of the index finger bilaterally at 15-minute intervals twice before , once during , and three times after a 30-minute treatment session . The ALTENS treatment was given at 4 Hz at an intensity just below pain threshold delivered to acupuncture points in the h and and wrist . The placebo treatment was similarly delivered , except that the intensity of stimulation was just above sensation threshold . Neither the ALTENS treatment nor the placebo treatment produced a significant change in pain threshold . There was no correlation between initial pain threshold and change in pain threshold . Implication s for the modulation of pain are discussed It is known that stimulation of thin cutaneous nerve fibers can induce long lasting analgesia through both supraspinal and segmental mechanisms , the latter often exhibiting restricted receptive fields . On this basis , we recently developed a new method , termed cutaneous field stimulation ( CFS ) , for localized stimulation of A delta and C fibers in the superficial part of the skin . In the present study , we have evaluated the effects of CFS on non-nociceptive and nociceptive skin senses . We compared the effects of CFS with those of conventional transcutaneous electrical nerve stimulation ( TENS ) , known to preferentially activate coarse myelinated fibers . A battery of sensory tests were made on the right volar forearm of 20 healthy subjects . CFS ( 16 electrodes , 4 Hz per electrode , 1 ms , up to 0.8 mA ) and TENS ( 100 Hz , 0.2 ms , up to 26 mA ) applied either on the right volar forearm ( homotopically ) , or on the lower right leg ( heterotopically ) were used as conditioning stimulation for 25 min . The tactile threshold was not affected by either homo- or heterotopical CFS or TENS . The mean thresholds for detecting warming or cooling of the skin were increased by 0.4 - 0.9 degrees C after homo- but not heterotopical CFS and TENS . Regarding nociceptive skin senses , homo- but not heterotopical CFS , markedly reduced CO2-laser evoked A delta- and C fiber mediated heat pain to 75 and 48 % of control , respectively , and mechanically evoked pain to 73 % of control . Fabric evoked prickle , was not affected by CFS . Neither homo- nor heterotopical TENS induced any marked analgesic effects . It is concluded that different qualities of nociception can be differentially controlled by CFS OBJECTIVE To determine if interferential current ( IFC ) or transcutaneous electric nerve stimulation ( TENS ) alters C and A delta fiber-mediated thermal perception thresholds . DESIGN Single-blind , r and omized controlled trial . SETTING Laboratory . PARTICIPANTS One hundred forty healthy women volunteers ( mean age + /- st and ard deviation , 20.6+/-2.7 y ) . INTERVENTIONS Subjects were r and omly and exclusively assigned to 1 of 7 groups ( n=20 in each ) : 0 , 5 , and 100 Hz of IFC ; 5 and 100 Hz of TENS ; placebo and control stimulation . Stimulation was applied through 2 electrodes placed over the median nerve . Warm sensation , cold sensation , hot pain , and cold pain perception thresholds were measured from the thenar eminence by using a quantitative sensory testing device and a method of limits algorithm . MAIN OUTCOME MEASURES Warm sensation , cold sensation , hot pain , and cold pain thresholds ( degrees C ) before , during , and after stimulation . RESULTS There was a statistically significant effect of time for all 4 thermal perception thresholds ( separate 2-way analyses of variance with repeated measures , all P<.001 ) . There were no statistically significant differences between experimental groups , nor any interaction effects ( all P>.05 ) . CONCLUSIONS Neither IFC nor TENS altered C and A delta fiber-mediated thermal perception thresholds . The results suggest that any analgesic mechanisms with these modalities are likely to be complex 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 OBJECTIVES To evaluate quantitatively the effectiveness and clinical relevance of various parameters of electrical stimulation used to relieve acute and chronic pain and to further knowledge of the mechanisms that may underlie the physiologic response produced by the transcutaneous application of each type of current . DESIGN A nociceptive flexion reflex ( RIII reflex ) elicited in the lower limb by electrical stimulation of the sural nerve at the ankle was studied before , during , and after application of the following conditioning stimuli : ( 1 ) non-noxious transcutaneous electrical nerve stimulation (TENS)--low-intensity ( 2mA ) , short- duration ( 0.1 msec ) , and high-frequency ( 100Hz ) rectangular pulses ( TENS1 ) ; ( 2 ) noxious TENS -- high-intensity ( 20mA ) , long- duration ( 2 msec ) , and low-frequency ( 3Hz ) rectangular pulses ( TENS2 ) ; ( 3 ) noxious piezo-electric current (PEC)--high-voltage , low-charge , low-intensity , and low-frequency rectangular pulses delivered by a piezo-electric ceramic device ( PECs1 ) ; ( 4 ) a sham PEC situation in which the piezo-electric device did not produce any electric current ( Sham PEC ) . Each conditioning stimulus ( TENS1 , TENS2 , PECs1 , Sham PEC ) was applied for a 2-minute period either segmentally on the sural nerve itself or heterotopically on the skin overlying the first interosseous space of the contralateral h and . PARTICIPANTS Twenty-four healthy volunteers ( 14 women , 10 men , 19 to 52 years of age ) , who were briefed and familiarized with the experimental procedure . During the experimental sessions , subjects were prone in bed to ensure muscular relaxation . MEASURES Value of the nociceptive RIII reflex before , during , and after application of conditioning stimuli in the four procedures described above . This reflex was selected because it has been shown to be an objective and physiologic correlate of pain . RESULTS Non-noxious TENS1 stimulation applied segmentally produced inhibitions of the RIII reflex only during the 2-minute conditioning period . When given segmentally , the noxious TENS2 stimulation produced a facilitatory effect during the 2 minutes of application , followed by significant inhibitory after-effects . The administration of TENS2 heterotopically result ed in inhibitions of the RIII reflex both during and after the 2-minute conditioning period . Application of PECs1 , whether segmentally or heterotopically , produced powerful and long-lasting inhibitory after-effects , especially with the heterotopic paradigm . These effects were associated with long-lasting local changes to the skin of the neurogenic inflammation type , which were well tolerated by all subjects . Application of Sham PEC did not result in significant modification of either the RIII reflex or the skin . CONCLUSIONS These data are discussed in terms of possible spinal and supraspinal mechanisms involving inhibitory descending controls and underline the potential clinical use of PECs1 in the treatment of pain OBJECTIVE To investigate to what extent a single 60-minute session of transcutaneous electrical nerve stimulation ( TENS ) would modify chronic clinical pain , acute experimental pain , and the flexion reflex evoked in chronic low back pain patients . STUDY DESIGN Thirty young subjects with chronic low back pain were r and omly allocated to two groups , receiving either TENS or placebo stimulation to the lumbosacral region for 60 minutes . The flexion reflex was elicited by an electrical stimulation applied to the subject 's right sole and recorded electromyographically from the biceps femoris and the tibialis anterior muscles . MAIN OUTCOME MEASURES Subjective sensation of low back pain and the electrically induced pain were measured by two separate visual analog scales , termed VAS(LBP ) and VAS(FR ) , respectively . Data obtained before , during , and 60 minutes after TENS and placebo stimulations were analyzed using repeated measures ANOVA . RESULTS The VAS(LBP ) score was significantly reduced to 63.1 % of the prestimulation value after TENS ( p<.001 ) , but the reduction was negligible after placebo stimulation ( to 96.7 % , p = .786 ) . In contrast , no significant change was found in the VASFR score ( p = .666 ) and the flexion reflex area ( p = .062 ) during and after stimulation within each group and between the two groups ( p = .133 for VASFR and p = .215 for flexion reflex area ) . CONCLUSIONS The same TENS protocol had different degrees of antinociceptive influence on chronic and acute pain in chronic low back pain patients Transcutaneous electrical nerve stimulation ( TENS ) is commonly used for pain relief . However , little robust research exists regarding the combination of parameters required to provide effective doses . This study investigated the hypoalgesic effects of different parameter combinations , applied simultaneously at two sites ( segmental and extrasegmental ) , on pressure pain threshold ( PPT ) in pain‐free humans . Two‐hundred and eight volunteers ( median age 22 years , range 20–26 ) were r and omized to eight groups : six active TENS groups , placebo and control . Parameter combinations were such that frequency always differed at each site ( 110Hz or 4Hz ) , but intensity could be either the same or different levels : high ( to tolerance without pain ) or low ( strong but comfortable ) . TENS was administered to the forearm over the radial nerve and the ipsilateral leg below the fibular head for 30min with monitoring for 30 further minutes . PPT measurements were taken bilaterally from the mid‐point of first dorsal interosseous muscle , by an independent blinded rater , at baseline and at six subsequent 10‐min intervals . Log‐transformed data were analysed using repeated‐ measures analysis of covariance ( baseline values and gender as covariates ) . Those groups using high‐intensity stimulation at the segmental stimulation sites showed significantly greater hypoalgesia than placebo ( p<0.025 in each case ) . The largest hypoalgesic effect was for simultaneous high‐intensity stimulation at segmental and extrasegmental sites , using different frequencies . These results reaffirm that high‐intensity stimulation ( regardless of frequency ) is of fundamental importance in effective dosage & NA ; Transcutaneous electrical nerve stimulation ( TENS ) is a popular form of electrostimulation . Despite an extensive research base , there remains no consensus regarding the parameter selection required to achieve maximal hypoalgesic effects . The aim of this double blind , sham‐controlled study was to investigate the relative hypoalgesic effects of different TENS parameters ( frequency , intensity and stimulation site ) upon experimentally induced mechanical pain . Two hundred and forty participants were recruited in order to provide statistical analysis with 80 % power at & agr;=0.05 . Subjects were r and omised to one of the six TENS groups , a control , and a sham TENS group ( n=30 , 15 males , 15 females , per group ) . TENS groups differed in their combinations of stimulation ; frequency ( 4 or 110 Hz ) , intensity ( ‘ to tolerance ’ or ‘ strong but comfortable ’ ) and stimulation site ( segmental – over the distribution of the radial nerve or , extrasegmental – over acupuncture point ‘ gall bladder 34 ’ , or a combination of both segmental and extrasegmental ) . Pulse duration was fixed at 200 & mgr;s . Stimulation was delivered for 30 min and subjects were then monitored for a further 30 min . Mechanical pain threshold ( MPT ) was measured using a pressure algometer and taken from the first dorsal interosseous muscle of the dominant h and , ipsilateral to the stimulation site . MPT measures were taken , at baseline , and at 10‐min intervals for 60 min . Difference scores were analysed using repeated measures and one‐way ANOVA and relevant post hoc tests . Low frequency , high intensity , extrasegmental stimulation produced a rapid onset hypoalgesic effect , which increased during the stimulation period ( P<0.0005 control and sham ) and was sustained for 30 min post‐stimulation ( P<0.0005control , P=0.024sham ) . Whilst high frequency , ‘ strong but comfortable ’ intensity , segmental stimulation produced comparable hypoalgesic levels during stimulation , this effect was not sustained post‐stimulation . Stimulation at a combination of the two sites did not produce any greater hypoalgesic effects . These results may have implication s for the clinical use of sensory stimulation This study compared the effects of high intensity , low frequency transcutaneous electrical nerve stim
Output:
| Conventional TENS has overall conflicting evidence of efficacy , this is derived from " strong " evidence of efficacy ( generally consistent findings in multiple high- quality RCTs ) on pressure pain but strong evidence of inefficacy on other pain models . "
Limited " evidence ( positive findings from 1 RCT ) of hypoalgesia exists for some novel parameters .
Low-intensity , low-frequency , local TENS has strong evidence of inefficacy .
Inappropriate TENS ( using " barely perceptible " intensities ) has moderate evidence of inefficacy .
DISCUSSION The level of hypoalgesic efficacy of TENS is clearly dependent on TENS parameter combination selection ( defined in terms of intensity , frequency , and stimulation site ) and experimental pain model . |
MS211467 | ***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 purpose was to evaluate low-dose CT colonography without cathartic cleansing in terms of image quality , polyp visualization and patient acceptance . Sixty-one patients scheduled for colonoscopy started a low-fiber diet , lactulose and amidotrizoic-acid for fecal tagging 2 days prior to the CT scan ( st and ard dose , 5.8–8.2 mSv ) . The original raw data of 51 patients were modified and reconstructed at simulated 2.3 and 0.7 mSv levels . Two observers evaluated the st and ard dose scan regarding image quality and polyps . A third evaluated the presence of polyps at all three mSv levels in a blinded prospect i ve way . All observers were blinded to the reference st and ard : colonoscopy . At three times patients were given question naires relating to their experiences and preference . Image quality was sufficient in all patients , but significantly lower in the cecum , sigmoid and rectum . The two observers correctly identified respectively 10/15 ( 67 % ) and 9/15 ( 60 % ) polyps ≥10 mm , with 5 and 8 false-positive lesions ( st and ard dose scan ) . Dose reduction down to 0.7 mSv was not associated with significant changes in diagnostic value ( polyps ≥10 mm ) . Eighty percent of patients preferred CT colonography and 13 % preferred colonoscopy ( P<0.001 ) . CT colonography without cleansing is preferred to colonoscopy and shows sufficient image quality and moderate sensitivity , without impaired diagnostic value at dose-levels as low as 0.7 mSv PURPOSE To prospect ively evaluate the diagnostic performance of magnetic resonance ( MR ) colonography by using limited bowel preparation in patients with polyps of 10 mm or larger in diameter in a population at increased risk for colorectal cancer , with optical colonoscopy as the reference st and ard . MATERIAL S AND METHODS The institutional review boards of all three hospitals approved the study . All patients provided written informed consent . In this multicenter study , patients undergoing colonoscopy because of a personal or family history of colorectal cancer or adenomatous polyps were included . Two blinded observers independently evaluated T1- and T2-weighted MR colonographic images obtained with limited bowel preparation ( bright-lumen fecal tagging ) for the presence of polyps . The limited bowel preparation consisted of a low-fiber diet , with ingestion of lactulose and an oral gadolinium-based contrast agent ( with all three major meals ) starting 48 hours prior to imaging . Results were verified with colonoscopic outcomes . Patient sensitivity , patient specificity , polyp sensitivity , and interobserver agreement for lesions of 10 mm or larger were calculated for both observers individually and combined . RESULTS Two hundred patients ( mean age , 58 years ; 128 male patients ) were included ; 41 patients had coexistent symptoms . At colonoscopy , 12 patients had 22 polyps of 10 mm or larger . Per-patient sensitivity was 58 % ( seven of 12 ) for observer 1 , 67 % ( eight of 12 ) for observer 2 , and 75 % ( nine of 12 ) for both observers combined for polyps of 10 mm or larger . Per-patient specificity was 95 % ( 178 of 188 ) for observer 1 , 97 % ( 183 of 188 ) for observer 2 , and 93 % ( 175 of 188 ) for both observers combined . Per-polyp sensitivity was 55 % ( 12 of 22 ) for observer 1 , 50 % ( 11 of 22 ) for observer 2 , and 77 % ( 17 of 22 ) for both observers combined . Interobserver agreement was 93 % for identification of patients with lesions of 10 mm or larger . CONCLUSION In patients at increased risk for colorectal cancer , specificity of MR colonography by using limited bowel preparation was high , but sensitivity was modest PURPOSE To investigate the sensitivity and specificity of polyp detection and the image quality of computed tomographic ( CT ) colonography at different radiation dose levels and to study effective doses reported in literature on CT colonography . MATERIAL S AND METHODS CT colonography and colonoscopy were performed with 100 mAs in 50 consecutive patients at high risk for colorectal cancer ; 50- and 30-mAs CT colonographic examinations were simulated with controlled addition of noise to raw transmission measurements . One radiologist r and omly evaluated all original and simulated images for the presence of polyps and scored image quality . Differences in image quality were assessed with the Wilcoxon rank test . Scan protocol s from the literature and recent ( unpublished ) up date s were collected . RESULTS In nine of 10 patients with polyps 5 mm in diameter or larger ( sensitivity , 90 % ) and in seven of 17 patients with polyps smaller than 5 mm , polyps were correctly identified with CT colonography at all dose levels . Specificity for patients without polyps 5 mm or larger was 53%-60 % at all dose levels and for patients without any polyps was 26 % ( at 100 and 50 mAs ) and 48 % ( at 30 mAs ) . Image quality decreased significantly as the dose level decreased . The median effective doses ( supine and prone positions ) calculated from protocol s reported in the literature and up date s were 7.8 and 8.8 mSv , respectively . CONCLUSION Although image quality decreases significantly at 30 mAs ( 3.6 mSv ) , polyp detection remains unimpaired . The median dose for CT colonography at institutions that perform CT colonographic research is currently 8.8 mSv The aim of this prospect i ve trial was to evaluate sensitivity and specificity of bright lumen magnetic resonance colonography ( MRC ) in comparison with conventional colonoscopy ( CC ) . A total of 120 consecutive patients with clinical indications for CC were prospect ively examined using MRC ( 1.5 Tesla ) which was then followed by CC . Prior to MRC , the cleansed colon was filled with a gadolinium-water solution . A 3D GRE sequence was performed with the patient in the prone and supine position , each acquired during one breathhold period . After division of the colon into five segments , interactive data analysis was carried out using three-dimensional post-processing , including a virtual intraluminal view . The results of CC served as a reference st and ard . In all patients MRC was performed successfully and no complications occurred . Image quality was diagnostic in 92 % ( 574/620 colonic segments ) . On a per-patient basis , the results of MRC were as follows : sensitivity 84 % ( 95 % CI 71.7 - 92.3 % ) , specificity 97 % ( 95 % CI 89.0 - 99.6 % ) . Five flat adenomas and 6/16 small polyps ( < or = 5 mm ) were not identified by MRC . MRC offers high sensitivity and excellent specificity rates in patients with clinical indications for CC . Improved MRC techniques are needed to detect small polyps and flat adenomas BACKGROUND AND STUDY AIMS The purpose of this study was to evaluate dark-lumen magnetic resonance ( MR ) colonography prospect ively in patients with incomplete conventional colonoscopy . PATIENTS AND METHODS Thirty-two patients with incomplete conventional colonoscopy underwent same-day dark-lumen MR colonography on the basis of a st and ard protocol . The depiction of colorectal diseases was assessed in the following colon segments : cecum , ascending colon , transverse colon , descending colon , sigmoid colon , and rectum . The reasons for incomplete colonoscopy included high- grade stenosis in 26 patients ( four with occlusive cancer , 12 with fibrotic stenosis based on recurrent sigmoid diverticulitis , eight with Crohn's-induced stenosis , and two with nonsteroidal anti-inflammatory drug colonopathy ) , extreme patient intolerance in one patient , and technical challenges associated with an elongated colon in five patients . The results of MR colonography were compared with the findings of the initial conventional colonoscopy , the histopathological outcome , and follow-up colonoscopy when possible . RESULTS All high- grade stenoses were confirmed on MR colonographic data sets . Of the 26 patients with high- grade stenosis , 19 underwent surgery with histopathological confirmation of the initial diagnosis . Follow-up colonoscopy was carried out in 14 patients with surgically treated high- grade stenosis . In six of these 14 patients , nine polyps identified at the initial MR colonography were confirmed and removed during a postoperative conventional colonoscopy . Two polyps ( 5 mm and 8 mm in diameter ) identified on postoperative conventional colonoscopy had not been seen preoperatively at MR colonography . One polyp seen on MR colonography was not identified in the follow-up colonoscopy . CONCLUSION Dark-lumen MR colonography is a feasible and useful method of evaluating the entire colon in patients with incomplete conventional colonoscopy PURPOSE To prove the feasibility of air-distended magnetic resonance colonography ( MRC ) and compare it with water-based distention . MATERIAL S AND METHODS In five volunteers , the colon was imaged twice : once after distending the colon with air and a second time after distending the colon with water . A total of 50 patients , who had been referred to colonoscopy for a suspected colorectal pathology were r and omized into water-distention ( N = 25 ) and air-distention ( N = 25 ) groups . A contrast-enhanced T1-weighted three-dimensional volume interpolated breath-hold ( VIBE ) sequence was collected . Comparative analysis was based on qualitative ratings of image quality and bowel distention , as well as contrast-to-noise ratio ( CNR ) measurements for the colonic wall with respect to the colonic lumen . In addition , patient acceptance was evaluated . RESULTS Inflammatory changes and colorectal masses were correctly identified on MRC in eight patients each . One 4-mm polyp identified at colonoscopy was missed on water-distended MRC . There were no false positive findings . No significant differences were found between air- and water-distention regarding discomfort levels and image quality . The presence of air in the colonic lumen was not associated with susceptibility artifacts . CNR of the contrast-enhanced colonic wall , as well as bowel distention , were superior on air-distended three-dimensional data sets . CONCLUSION MRC can be performed using either water or air for colonic distention . Both techniques permit assessment of the colonic wall and identification of colorectal masses . While discomfort levels are similar for both agents , MRC with air provides higher CNR and better colonic distention Recent improvements in hardware and software , lack of side effects , as well as diagnostic accuracy make magnetic resonance imaging a natural c and i date for preventative imaging . Thus , the purpose of the study was to evaluate the feasibility of a comprehensive 60-min MR-based screening examination in healthy volunteers and a limited number of patients with known target disease . In ten healthy volunteers ( 7 men , 3 women ; mean age , 32.4 years ) and five patients ( 4 men , 1 woman ; mean age , 56.2 years ) with proven target disease we evaluated the performance of a comprehensive MR screening strategy by combining well-established organ-based MR examination components encompassing the brain , the arterial system , the heart , the lungs , and the colon . All ten volunteers and five patients tolerated the comprehensive MR examination well . The mean in-room time was 63 min . In one volunteer , insufficient colonic cleansing on the part of the volunteer diminished the diagnostic reliability of MR colonography . All remaining components of the comprehensive MR examination were considered diagnostic in all volunteers and patients . In the five patients , the examination revealed the known pathologies [ aneurysm of the anterior communicating artery ( n=1 ) , renal artery stenosis ( n=1 ) , myocardial infa rct ( n=1 ) , and colonic polyp ( n=2 ) ] . The outlined MR screening strategy encompassing the brain , the arterial system , the heart , the lung , and the colon is feasible . Further studies have to show that MR-based screening programs are cost-effective in terms of the life-years saved AIM To assess Magnetic resonance colonography with fat enema as a method for detection of colorectal neoplasm . METHODS Consecutive twenty-two patients underwent MR colonography with fat enema before colonoscopy . T1-weighted three-dimensional fast spoiled gradient-echo with inversion recovery sequence was acquired with the patient in the supine position before and 75 s after Gadopentetate Dimelumine administration . Where by , pre and post MR coronal images were obtained with a single breath hold for about 20 s to cover the entire colon . The quality of MR colonographs and patients ' tolerance to fat contrast medium was investigated . Colorectal neoplasms identified by MR colonography were compared with those identified on colonoscopy and sensitivity of detecting the lesions was calculated accordingly . RESULTS MR colonography with fat enema was well tolerated without sedation and analgesia . 120 out of 132 ( 90.9 % ) colonic segments were well distended and only 1 ( 0.8 % ) colonic segment was poor distension . After contrast enhancement scan , mean contrast-to-noise ratio ( CNR ) value between the normal colonic wall and lumen was 18.5 + /- 2.9 while mean CNR value between colorectal neoplasm and lumen was 20.2 + /- 3.1 . By Magnetic resonance colonography , 26 of 35 neoplasms ( sensitivity 74.3 % ) were detected . However , sensitivity of MRC was 95.5 % ( 21 of 22 ) for neoplasm larger than 10 mm and 55.6 % ( 5 of 9 ) for 5 - 10 mm neoplasm
Output:
| Significant heterogeneity was found for overall per patient sensitivity and specificity .
Conclusion MR-colonography can accurately detect colorectal polyps more than 10 mm in |
MS211468 | ***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 human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine was immunogenic , generally well tolerated , and effective against HPV-16 or HPV-18 infections , and associated precancerous lesions in an event-triggered interim analysis of the phase III r and omised , double-blind , controlled PApilloma TRIal against Cancer In young Adults ( PATRICIA ) . We now assess the vaccine efficacy in the final event-driven analysis . METHODS Women ( 15 - 25 years ) were vaccinated at months 0 , 1 , and 6 . Analyses were done in the according-to- protocol cohort for efficacy ( ATP-E ; vaccine , n=8093 ; control , n=8069 ) , total vaccinated cohort ( TVC , included all women receiving at least one vaccine dose , regardless of their baseline HPV status ; represents the general population , including those who are sexually active ; vaccine , n=9319 ; control , n=9325 ) , and TVC-naive ( no evidence of oncogenic HPV infection at baseline ; represents women before sexual debut ; vaccine , n=5822 ; control , n=5819 ) . The primary endpoint was to assess vaccine efficacy against cervical intraepithelial neoplasia 2 + ( CIN2 + ) that was associated with HPV-16 or HPV-18 in women who were seronegative at baseline , and DNA negative at baseline and month 6 for the corresponding type ( ATP-E ) . This trial is registered with Clinical Trials.gov , number NCT00122681 . FINDINGS Mean follow-up was 34.9 months ( SD 6.4 ) after the third dose . Vaccine efficacy against CIN2 + associated with HPV-16/18 was 92.9 % ( 96.1 % CI 79.9 - 98.3 ) in the primary analysis and 98.1 % ( 88.4 - 100 ) in an analysis in which probable causality to HPV type was assigned in lesions infected with multiple oncogenic types ( ATP-E cohort ) . Vaccine efficacy against CIN2 + irrespective of HPV DNA in lesions was 30.4 % ( 16.4 - 42.1 ) in the TVC and 70.2 % ( 54.7 - 80.9 ) in the TVC-naive . Corresponding values against CIN3 + were 33.4 % ( 9.1 - 51.5 ) in the TVC and 87.0 % ( 54.9 - 97.7 ) in the TVC-naive . Vaccine efficacy against CIN2 + associated with 12 non-vaccine oncogenic types was 54.0 % ( 34.0 - 68.4 ; ATP-E ) . Individual cross-protection against CIN2 + associated with HPV-31 , HPV-33 , and HPV-45 was seen in the TVC . INTERPRETATION The HPV-16/18 AS04-adjuvanted vaccine showed high efficacy against CIN2 + associated with HPV-16/18 and non-vaccine oncogenic HPV types and substantial overall effect in cohorts that are relevant to universal mass vaccination and catch-up programmes . FUNDING GlaxoSmithKline Biologicals BACKGROUND This phase III trial was to compare 5-fluorouracil ( 5-FU ) , adriamycin , and polyadenylic-polyuridylic acid ( poly A : U ) against 5-fluorouracil plus adriamycin ( FA ) for operable gastric cancer . PATIENTS AND METHODS From 1984 to 1989 , patients who had D(2 - 3 ) curative resection were r and omly assigned to receive chemotherapy or chemoimmunotherapy . Chemotherapy consisted of 12 mg/kg 5-FU every week for 18 months and 40 mg/m2 adriamycin every 3 weeks for 12 cycles . Chemoimmunotherapy consisted of FA plus 100 mg of poly A : U weekly for six cycles and was followed 6 months later by six weekly 50-mg booster injections . RESULTS A total of 292 patients were enrolled . After excluding 12 ineligible patients , 142 and 138 patients were allocated to each treatment . Patients were balanced with prognostic variables : age , sex , tumor location , differentiation , degree of tumor invasion ( T2-T4a ) , and lymph node status ( N0-N2 ) . During the 15-year follow-up , chemoimmunotherapy significantly prolonged overall ( P = 0.013 ) and recurrence-free ( P = 0.005 ) survivals compared with chemotherapy alone . The survival benefits were prominent in the subset of patients with T3/T4a , N2 , or stage III . Treatments were generally well tolerated in both arms . CONCLUSIONS These results indicate a survival advantage of chemoimmunotherapy with a regimen of FA and poly A : U in curatively resected gastric adenocarcinoma The toll‐like receptor ( TLR ) 7 agonist 852A , a small‐molecule imidazoquinoline , stimulates plasmacytoid dendritic cells to produce multiple cytokines . We conducted a Phase II study of 852A in patients with recurrent hematologic malignancies . The primary objective was assessing the activity of 852A administered subcutaneously twice weekly for 12 weeks . Secondary objectives were assessing the safety of 852A and its ability to activate the immune system with prolonged dosing . Patients with relapsed hematologic malignancies of any age with adequate organ function were eligible . Patients initiated dosing at 0.6 mg/m2 twice weekly and escalated by 0.2 mg/m2 after every two doses as tolerated to a target dose of 1.2 mg/m2 . Patients with responses or stable disease were eligible for additional cycles . Seventeen patients ( 15 males ) entered the study : 6 with AML , 5 ALL , 4 NHL , 1 Hodgkin 's lymphoma , and 1 multiple myeloma . The mean age was 41 years ( 12–71 years ) . The median number of prior chemotherapy regimens was 5 ( range = 1–14 ) . Thirteen patients completed all 24 injections . Grade 3‐4 toxicities included nausea , dyspnea , fever , myalgia , malaise , and cough . Responses included one complete response ( ALL ) , one partial response ( AML ) , two stable disease ( AML and NHL ) , and 9 progressive disease . This is the first in‐human hematologic malignancy trial of a subcutaneously ( SC ) delivered TLR7 agonist using a prolonged dosing schedule . 852A was safely administered up to 1.2 mg/m2 twice weekly with evidence of sustained tolerability and clinical activity in hematologic malignancies . Systemic TLR agonists for the treatment of hematologic malignancies warrant further study . Am . J. Hematol . 2012 . © 2012 Wiley Periodicals ,
Output:
| We show that targeting TLRs in cancer immunotherapy is a promising strategy for cancer therapy , and the specific TLR lig and s , either alone or combination , exhibit antitumor potential |
MS211469 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Summary : We initiated a r and omized study of amifostine ( the organic thiophosphate formerly known as WR-2721 ) given to patients during myeloablative conditioning therapy for allogeneic bone marrow transplantation . Amifostine was given at a dose of 1000 mg/day of conditioning and was well tolerated if attention was given to serum calcium levels , blood pressure and antiemetics . Since August 1998 , 60 patients ( 30 on each arm ) have completed the study . There was no significant difference in the days to neutrophil or platelet engraftment in either arm of the study . Significantly , the duration of grade I – IV mucositis was decreased in the group that received amifostine ( P=0.02 ) . Also grade III or IV infections ( P=0.008 ) , duration of antibiotic therapy ( P=0.03 ) and duration of fever ( P=0.04 ) were significantly reduced with amifostine . However , there were no differences in the incidence of grade III or IV mucositis , liver toxicity or renal toxicity . There were also no differences in early mortality , relapse and long-term survival . We conclude that amifostine , while reducing the duration of mucositis and infections ( possibly through some preservation of gut mucosal integrity ) , has a modest effect in allogeneic bone marrow transplants given the multiplicity of factors influencing organ toxicity and survival in this setting PURPOSE To evaluate chronic xerostomia and tumor control 18 and 24 months after initial treatment with amifostine in a r and omized controlled trial of patients with head- and -neck cancer ; at 12 months after radiotherapy ( RT ) , amifostine had been shown to reduce xerostomia without changing tumor control . METHODS AND MATERIAL S Adults with head- and -neck cancer who underwent once-daily RT for 5 - 7 weeks ( total dose , 50 - 70 Gy ) received either open-label amifostine ( 200 mg/m2 i.v . ) 15 - 30 min before each fraction of radiation ( n = 150 ) or RT alone ( control ; n = 153 ) . RESULTS Amifostine administration was associated with a reduced incidence of Grade > or = 2 xerostomia over 2 years of follow-up ( p = 0.002 ) , an increase in the proportion of patients with meaningful ( > 0.1 g ) unstimulated saliva production at 24 months ( p = 0.011 ) , and reduced mouth dryness scores on a patient benefit question naire at 24 months ( p < 0.001 ) . Locoregional control rate , progression-free survival , and overall survival were not significantly different between the amifostine group and the control group . CONCLUSIONS Amifostine administration during head- and -neck RT reduces the severity and duration of xerostomia 2 years after treatment and does not seem to compromise locoregional control rates , progression-free survival , or overall survival A r and omized phase 2 study was performed to investigate the efficacy/toxicity of combining concomitant boost radiation and weekly carboplatin/paclitaxel with or without amifostine in patients with locally advanced squamous cell carcinoma of the head and neck ( SCCHN ) Concurrent chemotherapy and radiation has improved the outcome for patients presenting with locally advanced squamous cell carcinomas of the head and neck ( SCCHN ) . These improvements have come at a cost of increased treatment-related toxicities . We previously reported the results of a phase II trial examining the role of concurrent carboplatin , paclitaxel , and daily radiotherapy ( RT ) in SCCHN . In an attempt to decrease these side effects , we conducted a prospect i ve phase II trial evaluating the role of amifostine ( Ethyol , MedImmune Oncology , Inc , Gaithersburg , MD ) in patients treated with this concurrent chemoRT scheme . From April 2002 to September 2004 , 19 patients with stage III-IV SCCHN were enrolled on a prospect i ve phase II trial . Treatment consisted of daily RT delivered to 70.2 Gy ( 1.8 Gy/fx ) with amifostine 500 mg IV ( < 1 hour before RT ) , and concurrent weekly carboplatin ( 100 mg/m2 ) and paclitaxel ( 40 mg/m2 ) . Median age was 58.5 years ( range , 48 to 70 years ) ; male to female ratio was , 83%:17 % ; Caucasian versus other was , 61%/39 % . Tumor characteristics based on histology were : primary cancers of the oropharynx ( 55.6 % ) ; supraglottic larynx ( 16.7 % ) ; hypopharynx ( 16.7 % ) ; oral cavity ( 5.6 % ) ; and unknown primaries ( 5.6 % ) . All patients presented with locally advanced , unresectable disease T4 ( 50 % ) , T3 ( 27.8 % ) , and advanced nodal disease ( N2b-N3 ) ( 78 % ) . Toxicities were measured weekly during treatment and at each follow-up visit . Disease response to therapy was determined 2 months after completion of therapy . Seventeen patients are evaluable for response and survival at 2 months following completion of RT . Eighty-four percent completed the prescribed radiation treatment , and 84 % of patients received more than six cycles of chemotherapy . The median number of missed chemotherapy cycles was 1.5 ( range , 0 to 5 cycles ) . Fifty-six percent of patients received more than 90 % of prescribed amifostine doses , with chemoRT-related toxicity being the most common reason for withholding the dose ( 77 % ) . Median doses of missed amifostine were three ( range , 0 to 30 doses ) . Grade 3 toxicities associated with therapy were : mucositis and dysphagia ( 40 % of patients each ) , dehydration ( 27 % ) , xerostomia ( 20 % ) , and dermatitis ( 20 % ) ; 53 % of patients experienced grade 3 leukopenia , while grade 3/4 neutropenia developed in 20%/13 % . No grade 4/5 nonhematologic toxicities were encountered . Forty percent of patients completed RT without unscheduled treatment breaks secondary to treatment-related toxicity . Median treatment-break time was 5 days ( range , 0 to 20 days ) . Clinical complete response at both the primary site of disease and neck was achieved in 75 % of patients 2 months following completion of RT . Weekly carboplatin and paclitaxel administered concurrently with definitive RT and daily amifostine is well tolerated , with over 85 % of patients completing therapy with acceptable toxicity . The addition of amifostine appears to decrease treatment-related toxicity without impacting efficacy This pilot study evaluates the degree of side effects during high-dose chemotherapy ( HD-VIC ) plus autologous bone marrow transplant ( HDCT ) and its possible prevention by the cytoprotective thiol-derivate amifostine . Additionally , the in-patient medical costs of both treatment arms were compared . 40 patients with solid tumours were r and omized to receive HD-VIC chemotherapy with or without amifostine ( 910 mg/m2at day 1–3 ) given as a short infusion prior to carboplatin and ifosfamide . Patients were stratified according to pretreatment . HDCT consisted of an 18 h infusion of carboplatin ( 500 mg/m2/d over 18 h ) , ifosfamide ( 4 g/m2/d over 4 h ) and etoposide ( 500 mg/m2/d ) all given for 3 consecutive days . All patients received prophylactic application of G-CSF ( 5 μg kg−1subcutaneously ) to ameliorate neutropenia after treatment . Patients were monitored for nephrotoxicity , gastrointestinal side effects , haematopoietic recovery , as well as frequency of fever and infections . The median fall of the glomerular filtration rate ( GFR ) was 10 % from baseline in the amifostine group ( 105 to 95 ml min−1 ) and 37 % in the control patient group ( 107 to 67 ml min−1 ) ( P < 0.01 ) . Amifostine-treated patients revealed a less pronounced increase in albumine and low molecular weight protein urinary excretion . Stomatitis grade III/IV occurred in 25 % without versus 0 % of patients with amifostine ( P = 0.01 ) . Acute nausea/vomiting was frequently observed immediately during or after the application of amifostine despite intensive antiemetic prophylaxis consisting of 5-HT3-receptor antagonists/dexamethasone/trifluorpromazine . However , delayed emesis occurred more often in the control patients . Engraftment of neutrophil ( > 500 μl−1 ) and thrombocytes ( > 25 000 μl−1)were observed at days 9 versus 10 and 10 versus 12 , respectively , both slightly in favour of the amifostine arm . In addition , a lower number of days with fever and a shortened duration of hospital stay were observed in the amifostine arm . The reduction of acute toxicity observed in the amifostine arm result ed in 30 % savings in costs for supportive care ( Euro 4396 versus Euro 3153 per patient ) . Taking into account the drug costs of amifostine , calculation of in-patient treatment costs from the start of chemotherapy to discharge revealed additional costs of Euro 540 per patient in the amifostine arm . This r and omized pilot study indicates that both organ and haematotoxicity of HD-VIC chemotherapy can be ameliorated by the use of amifostine . Additionally , a nearly complete preservation of GFR was observed in amifostine-treated patients which may be advantageous if repetitive cycles of HDCT are planned . Larger r and omized trials evaluating amifostine cytoprotection during high-dose chemotherapy are warranted . © 2001 Cancer Research Campaign PURPOSE To evaluate the cytoprotective impact of the interval between amifostine administration and radiotherapy ( RT ) . METHODS AND MATERIAL S In a nonr and omized study , we review ed the records of 177 patients with tumors localized in the pelvis ( prostate , bladder , or gynecologic cancer ) , upper abdomen ( pancreas , stomach , kidney ) , thorax ( lung and breast cancer ) , head and neck ( nasopharynx ) , soft tissue ( sarcomas ) , and central nervous system . The patient records were stratified according to whether the patients had undergone RT either 25 - 40 min ( Group 1 , 96 subjects ) or 10 - 15 min ( Group 2 , 81 subjects ) after i.v . amifostine administration . The mean toxicity score was the mean value of recorded acute radiation toxicity . The mean interruption time was the mean value of the recorded interruption time due to radiation toxicity . RESULTS A significantly reduced severity of symptoms related to oral ( p = 0.023 ) , esophageal ( p = 0.05 ) and rectal ( p = 0.015 ) mucosa was noted in Group 2 . A statistically significant reduction in the mean toxicity score ( p < 0.001 ) and mean interruption time ( p = 0.001 ) was observed in Group 2 vs. Group 1 . In terms of the incidence of radiation-induced dermatitis and alopecia , multivariate logistic analysis revealed only the total dose ( p = 0.018 ) and the amifostine-RT interval ( p = 0.002 ) as independent factors . CONCLUSION A significantly better cytoprotective effect of amifostine against radiation-induced mucositis , dermatitis , and alopecia was noted if RT was administered no later than 15 min after i.v . amifostine infusion . The results presented here need additional investigation with r and omized prospect i ve trials PURPOSE To determine the prophylactic properties of amifostine against acute and late toxicities from radiochemotherapy in patients with head- and -neck cancer . METHODS AND MATERIAL S Fifty patients were r and omized to receive conventional radiotherapy ( RT ) ( 2-Gy fractions , 5 days weekly , to a total of 60 - 74 Gy , depending on the tumor localization and TNM classification ) and carboplatin ( 90 mg/m(2 ) infusion once per week before RT ) . Amifostine ( 300 mg/m(2 ) ) was administered in the study group only 15 - 30 min before RT for 6 - 7.5 weeks . The primary study end point was the grading of acute and late nonhematologic toxicities ( mucositis , dysphagia , xerostomia ) induced by radiochemotherapy . Secondary end points included treatment duration , hematologic toxicity , and clinical outcome . RESULTS The treatment duration was significantly shorter in the amifostine-treated group ( p = 0.013 ) , because treatment interruptions were more frequent in the control group . Acute toxicities ( mucositis and dysphagia ) were less severe in the amifostine-treated group . By Week 3 , all in the control group experienced Grade 2 mucositis compared with only 9 % in the amifostine-treated group
Output:
| No guideline was possible for amifostine in any cancer treatment setting due to inadequate and conflicting evidence .
Conclusion Review of the amifostine studies for the prevention and treatment of oral mucositis has found insufficient evidence to support its use in any cancer treatment setting for this purpose . |
MS211470 | ***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 hypothesis that the adaptive capacity is higher in human upper- than lower-body skeletal muscle was tested . Furthermore , the hypothesis that more pronounced adaptations in upper-body musculature can be achieved by " low-volume high-intensity " compared with " high-volume low-intensity " exercise training was evaluated . A group of sedentary premenopausal women aged 45 ± 6 yr ( ± SD ) with expected high adaptive potential in both upper- and lower-extremity muscle groups participated . After r and om allocation to high-intensity swimming ( HIS , n = 21 ) , moderate-intensity swimming ( MOS , n = 21 ) , soccer ( SOC , n = 21 ) or a nontraining control group ( CON , n = 20 ) , the training groups completed three workouts per week for 15 wk . Resting muscle biopsies were obtained from the vastus lateralis muscle and deltoideus muscle before and after the intervention . After the training intervention , a larger ( P < 0.05 ) increase existed in deltoideus muscle of the HIS group compared with vastus lateralis muscle of the SOC group for citrate synthase maximal activity ( 95 ± 89 vs. 27 ± 34 % ) , citrate synthase protein expression ( 100 ± 29 vs. 31 ± 44 % ) , 3-hydroxyacyl-CoA dehydrogenase maximal activity ( 35 ± 43 vs. 3 ± 25 % ) , muscle glycogen content ( 63 ± 76 vs. 20 ± 51 % ) , and expression of mitochondrial complex II , III , and IV . Additionally , HIS caused higher ( P < 0.05 ) increases than MOS in deltoideus muscle citrate synthase maximal activity , citrate synthase protein expression , and muscle glycogen content . In conclusion , the deltoideus muscle has a higher adaptive potential than the vastus lateralis muscle in sedentary women , and " high-intensity low-volume " training is a more efficient regime than " low-intensity high-volume " training for increasing the aerobic capacity of the deltoideus muscle AIM It has been suggested , that water exercise is less effective than weight-bearing exercise on l and for body fat reduction . METHODS To test this hypothesis 38 middle-aged obese women ( 25 - 47 % body fat ) participated in a 13 week exercise-diet program to compare the effects of aerobic exercise in water versus walking on l and on indices of fat reduction and weight loss changes . Subjects were r and omly assigned to 1 of 3 exercise groups : 1 ) walking on l and ( WL ) , 2 ) swimming ( SW ) at 27 degrees C water temperature and 3 ) walking in 29 degrees C water ( WW ) at the shallow end of a declining pool with the water at navel height . Subjects in the SW group alternated breast- , side- , and backstroke swimming without face immersion . Exercise parameters were kept constant for all three groups . Subjects participated in supervised exercise sessions for 40 min , 4 times a week at 70 % of age-predicted maximum heart rate . Subjects were tested before and after the 13-week experimental period . RESULTS Significant reductions in body weight , ( 5.9 kg ) , percent body fat , ( 3.7 % ) , and skinfold and girth measurements , occurred in all groups . There where no significant differences between groups . CONCLUSIONS The results of this study indicate that there are no differences in the effect of aerobic activities in the water versus weight-bearing aerobic exercise on l and on body composition components as long as similar intensity , duration and frequency are used 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 Objective Swimming is often recommended in the prevention and treatment of hypertension . Few studies have investigated the effect of swimming training on blood pressure ( BP ) . Our objective was to evaluate 6 months of supervised moderate swimming or walking on BP in previously sedentary , normotensive , older women . Design Women aged 50–70 years ( n = 116 ) were r and omly assigned to a supervised 6-month swimming or walking programme . They were further r and omized to receive usual care or a behavioural intervention package . Methods Exercise comprised 3 sessions/week with a warm-up , cool down , and 30-min of moderate intensity walking or swimming . BP was recorded for 20 min supine , and 5 min st and ing . Assessment s were made at 0 and 6 months . Results At baseline , mean supine BP ( ± SD ) was 115.7 ± 1.3/66.8 ± 0.7 mmHg . Swimming improved swim distance by 78.1 m ( 29.3 % ) [ 95 % confidence interval ( CI ) ; 66.7 , 89.4 ] and walk time by 0.58 min ( 3.8 % ) ( 0.41 , 0.74 ) . Walking decreased walk time by 1.0 min ( 6.5 % ) ( 0.81 , 1.19 ) . After adjustment for initial BP , age , hypertension treatment status and change in weight , swimming increased supine and st and ing systolic BP relative to walking by 4.4 mmHg ( 1.2 , 7.5 ) ( P = 0.008 ) and 6.0 mmHg ( 2.6 , 9.5 ) ( P = 0.001 ) , respectively . Supine and st and ing diastolic BP increased by 1.4 mmHg ( −0.14 , 3.0 ) ( P = 0.07 ) and 1.8 mmHg ( −0.02 , 3.5 ) ( P = 0.05 ) , respectively . Conclusion Relative to moderately paced walking , regular swimming significantly elevates BP in previously sedentary , normotensive , older women . This finding may have important implication s for exercise prescription in older subjects OBJECTIVE To investigate the medium-term benefits of a swimming program in schoolchildren and adolescents with moderate persistent atopic asthma ( MPAA ) . METHODS A r and omized , prospect i ve study of children and adolescents ( age 7 - 18 years ) with MPAA was carried out at the Hospital de Clínicas of Universidade Estadual de Campinas ( UNICAMP ) , Campinas , Brazil . After a 1-month run-in period , 61 patients ( 34 female ) were r and omized into two groups , a swimming group ( n = 30 ) and a control group ( n = 31 ) , and followed for 3 months . Both patient groups received inhaled fluticasone ( dry powder , 250 mcg twice a day ) and salbutamol as needed . The swim training program consisted of two weekly classes over a 3-month period for a total of 24 sessions . Both groups underwent spirometric assessment and methacholine challenge test -- provocative concentration of methacholine causing a 20 % fall in FEV1 (PC₂₀)--before and after the study period . Maximal inspiratory pressure ( MIP ) and maximal expiratory pressure ( MEP ) were measured only in the swimming group . RESULTS Significant increases in PC₂₀ ( pre-training , 0.31±0.25 ; post-training , 0.63±0.78 ; p = 0.008 ) , MIP ( pre-training , 67.08±17.13 cm H₂O ; post-training 79.46±18.66 ; p < 0.001 ) , and MEP ( pre-training , 71.69±20.01 cm H₂O ; post-training , 78.92±21.45 cm H₂O ; p < 0.001 ) were found in the swimming group . CONCLUSION Children and adolescents with MPAA subjected to a swim training program experienced a significant decrease in bronchial hyperresponsiveness , as determined by increased PC₂₀ values , when compared with asthmatic controls who did not undergo swim training . Participants in the swimming group also showed improvement in elastic recoil of the chest wall Reduced respiratory muscle strength in individuals with Down syndrome ( DS ) may affect speech respiratory variables such as maximum phonation duration ( MPD ) , initiation volume , and expired mean airflow . Research ers r and omly assigned adolescents with DS ( N = 28 ) to either 12 weeks of swim training ( DS-ST ) or a control group ( DS-NT ) . Repeated measures MANOVA demonstrated a significant increase in MPD for DS-ST participants from pretest to posttest , t(11 ) = -3.44 , p = 0.006 , that was not maintained at follow-up , t(11 ) = 6.680 , p < .001 . No significant change was observed for DS-NT participants across time , F(2 , 11 ) = 4.20 , p = 0.044 . The lack of long-term change in DS-ST participants may be related to the relatively short training period Purpose The present study examined the effects of 15 weeks of soccer training and two different swimming training protocol s on bone turnover in sedentary middle-aged women . Methods Eighty-three premenopausal mildly hypertensive women [ age : 45 ± 6 ( ±SD ) years , height : 165 ± 6 cm , weight : 80.0 ± 14.1 kg , body fat : 42.6 ± 5.7 % , systolic blood pressure/diastolic blood pressure : 138 ± 6/85 ± 3 mmHg ] were r and omized into soccer training ( SOC , n = 21 ) , high-intensity intermittent swimming ( HS , n = 21 ) , moderate-intensity swimming ( MS , n = 21 ) intervention groups , and a control group ( C , n = 20 ) . The training groups completed three sessions per week for 15 weeks . DXA scans were performed and resting blood sample s were drawn pre- and post-intervention . Results In SOC , plasma osteocalcin , procollagen type I N propeptide and C-terminal telopeptide increased ( P < 0.05 ) by 37 ± 15 , 52 ± 23 and 42 ± 18 % , respectively , with no changes in MS , HS and C. The intervention-induced increase in SOC was larger ( P < 0.05 ) than in MS , HS and C. In SOC , leg BMC increased ( P < 0.05 ) by 3.1 ± 4.5 % , with a larger increase in SOC than in C. Femoral shaft and trochanter bone mineral density ( BMD ) increased ( P < 0.05 ) by 1.7 ± 1.9 and 2.4 ± 2.9 % , respectively , in SOC , with a greater ( P < 0.05 ) change in SOC than in MS and C , whereas total body and total leg BMD did not change in any of the groups . Conclusion In conclusion , 15 weeks of soccer training with sedentary middle-aged women caused marked increases in bone turnover markers , with concomitant increases in leg bone mass . No changes in bone formation and resorption markers were seen after prolonged submaximal or high-intensity intermittent swimming training . Thus , soccer training appears to provide a powerful osteogenic stimulus in middle-aged women Purpose We tested the hypothesis that low-volume high-intensity swimming has a larger impact on insulin sensitivity and glucose control than high-volume low-intensity swimming in inactive premenopausal women with mild hypertension . Methods Sixty-two untrained premenopausal women were r and omised to an inactive control ( n = 20 ; CON ) , a high-intensity low-volume ( n = 21 ; HIT ) or a low-intensity high-volume ( n = 21 ; LIT ) training group . During the 15-week intervention period , HIT performed 3 weekly 6–10 × 30-s all-out swimming intervals ( average heart rate ( HR ) = 86 ± 3 % HRmax ) interspersed by 2-min recovery periods and LIT swam continuously for 1 h at low intensity ( average HR = 73 ± 3 % HRmax ) . Fasting blood sample s were taken and an oral glucose tolerance test ( OGTT ) was conducted pre- and post-intervention . Results After HIT , resting plasma [ insulin ] was lowered ( 17 ± 34 % ; P < 0.05 ) but remained similar after LIT and CON . Following HIT , 60-min OGTT plasma [ insulin ] and [ glucose ] was lowered ( 24 ± 30 % and 10 ± 16 % ; P < 0.05 ) but remained similar after LIT and CON . Total area under the curve for plasma [ glucose ] was lower ( P < 0.05 ) after HIT than LIT ( 660 ± 141 vs. 860 ± 325 mmol min L−1 ) . Insulin sensitivity ( HOMA-IR ) had increased ( P < 0.05 ) by 22 ± 34 % after HIT , with no significant change after LIT or CON , respectively . Plasma soluble intracellular cell adhesion molecule 1 was lowered ( P < 0.05 ) by 4 ± 8 and 3 ± 9 % after HIT and CON , respectively , while plasma soluble vascular
Output:
| Conclusions Swimming may offer robust beneficial effects on cardiorespiratory fitness and body composition across multiple population s and effects may be comparable to other exercise modes . |
MS211471 | ***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 PURPOSE To compare the outcome of immediately loaded single implants inserted with medium ( from 25 to 35 Ncm ) or high insertion torques ( > 80 Ncm ) . MATERIAL S AND METHODS Fifty patients received two single non-adjacent implants , each r and omly inserted flapless with a torque between 25 to 35 Ncm or > 80 Ncm according to a split-mouth design . Non-occluding temporary crowns were immediately placed on provisional abutments and definitive crowns were delivered after 6 weeks . Patients were followed for 6 months after initial loading . Outcome measures were crown/implant failures , complications , peri-implant marginal bone level changes , postoperative pain and presence of peri-implant apical radiolucency . RESULTS No drop-out occurred . Seven implants inserted with a torque between 25 to 35 Ncm failed versus none of the implants inserted with a torque > 35 Ncm . With the exception of crown/implant failures ( exact McNemar significance P = 0.0156 , difference in proportions : -0.12 ; 95 % CI -0.21 to -0.02 ) there were no statistically significant differences between groups for the other outcome measures . CONCLUSIONS It is preferable to insert single implants with a high insertion torque ( > 80 Ncm ) , to minimise early implant failures , when loading them immediately OBJECTIVES The aim of the present split-mouth study is to assess the peri-implant conditions around early-loaded s and blasted and acid-etched ( SLA ) implants , 5 years after abutment connection and to compare , in the same patients , the results obtained with a st and ard protocol using identical implants with a TPS surface . MATERIAL AND METHODS Surgical procedure was performed by the same operator and was identical at test ( SLA ) and control ( TPS ) sites , in 32 healthy patients . Abutment connection was carried out at 35 N cm 6 weeks postsurgery for test sites and 12 weeks for the controls . Patients were seen regularly , for control and professional cleaning . At 60 months , clinical measures and radiographic bone changes were recorded by the same operator , blind to the type of surface of the implant , on 27 patients , as five patients were lost to follow-up . RESULTS A total number of 106 implants were examined . No implant was lost . No significant differences were found with respect to the presence of plaque [ modified plaque index ( mPI ) 0.27+/-0.56 vs. 0.32+/-0.54 ] , bleeding on probing ( 29 % vs. 32 % ) , mean pocket depth ( 3.2+/-1 vs. 3.2+/-1 mm ) or mean marginal bone loss ( 0.32+/-1.04 vs. 0.44+/-1.12 mm ) between test and control . Four implants that presented ' spinning ' at the time of abutment connection presented no significant differences from the rest of the test sites . CONCLUSION The results of this prospect i ve study confirm that SLA implants , under defined conditions , are suitable for early loading at 6 weeks in both the m and ible and the maxilla . Limited implant spinning , occasionally found at abutment connection , produces no detrimental effect on the clinical outcome when properly h and led PURPOSE To compare the efficacy of immediate functionally loaded implants placed with a flapless procedure ( test group ) versus implants placed after flap elevation and conventional load-free healing ( control group ) in partially edentulous patients . MATERIAL S AND METHODS Forty patients were r and omized : 20 to the flapless immediately loaded group and 20 to the conventional group . To be immediately loaded , implants had to be inserted with a minimum torque > 45 Ncm . Implants in the immediately loaded group were provided with full acrylic resin temporary restorations the same day . Implants in the conventional group were submerged ( anterior region ) or left unsubmerged ( posterior region ) and were left load-free for 3 months ( m and ibles ) or 4 months ( maxillae ) . Provisional restorations were replaced with definitive single metal-ceramic crowns 1 month postloading . Outcome measures were prosthesis and implant failures , biological and prosthetic complications , postoperative edema , pain , and use of analgesics . Independent sample chi2 tests , Mann-Whitney tests , t tests , and paired t tests were used with a significance level of .05 . RESULTS Fifty-two implants were placed in the flapless group and 56 in the conventionally loaded group . In the flapless group , 1 flap had to be raised to control the direction of the bur and 1 implant did not reach the planned primary stability and was treated as belonging to the conventional group . After 3 years no dropouts or failures occurred . There was no statistically significant difference for complications ; however , patients in the conventional group had significantly more postoperative edema and pain and consumed more analgesics than those in the flapless group . Osstell values were significantly higher at baseline in the flapless group ( P = .033 ) . When comparing baseline data with years 1 , 2 , and 3 within each group , mean Osstell values of the flapless group did not increase , whereas there were statistically significant increases in the Periotest values . CONCLUSIONS Implants can be successfully placed flapless and loaded immediately without compromising success rates ; the procedure decreases treatment time and patient discomfort Purpose : The aim of this study was to evaluate and compare immediate-loaded implant-retained m and ibular overdentures and delayed-loaded implant-retained m and ibular overdentures . Material s : Ten completely edentulous male patients received 40 dental implants . Patients were r and omly divided into 2 equal groups , 5 patients each . Patients of both groups received conventional maxillary complete denture and had stage 1 surgery for placing 4 dental implant fixtures , 2 on each side anterior to the mental foramina . Group A : One-stage surgical procedure and immediate loading . Patients in this group received m and ibular bar-retained overdenture supported by 4 endosseous implants loaded immediately after implant placement . Group B : The original 2-stage concept and delayed loading . Patients in this group received m and ibular bar-retained overdenture supported by 4 endosseous implants that remained submerged for a period of 4 months before loading . The patients were evaluated clinical ly and radiographically immediately after overdenture delivery and after 6 months , 12 months , 18 months , and 24 months . Results : The results of clinical evaluation showed no statistical significant difference between the 2 groups regarding the effect of treatment . The radiographic assessment showed no statistical significant difference in mesial and distal alveolar bone loss at the different intervals of the follow-up period , except at the 12-month period , where immediately loaded implants showed a decrease in the amount of alveolar bone loss mesially and distally compared to delayed loaded implants . Conclusions : The results suggest that immediate-loaded implants provide promising results compared to delayed-loaded implants and can be a possible alternative procedure in implant dentistry This study was design ed to compare the results of immediate and delayed loading of implants with implant-retained m and ibular overdentures . Ten patients ( test group ) received 40 Brånemark System MKII implants ( 4 per patient ) placed in the interforaminal area of the m and ible . St and ard abutments were immediately screwed to the implants , rigidly connected with a bar , and immediately loaded with an overdenture . Ten patients ( control group ) received the same type and number of implants in the same area , but the implants were left to heal submerged . Four to 8 months later , st and ard abutments were screwed to the implants and the same prosthetic procedure was applied . Each implant was evaluated at the time of prosthetic loading and at 6 , 12 , and 24 months after the initial prosthetic load with the following parameters : modified Plaque Index ( MPI ) , modified Bleeding Index ( MBI ) , probing depth ( PD ) , and Periotest . Peri-implant bone resorption was evaluated on panoramic radiographs taken 12 and 24 months after initial prosthetic loading . No significant differences were found between the 2 groups regarding MPI , MBI , Periotest , peri-implant bone resorption , and PD at 6 and 24 months ( P > .05 ) . The only difference was found regarding PD values on the mesial and lingual sites at 12 months ( P < .05 ) . The cumulative success rate of implants was 97.5 % in both groups . Results from this study showed that immediate loading of endosseous implants rigidly connected with a U-shaped bar does not seem to have any detrimental effect on osseointegration . Conversely , this method significantly shortens the duration of treatment with relevant satisfaction for the patients OBJECTIVES The aim of the present study was to evaluate the outcome of immediate functional loading of implants in single-tooth replacement using two different installation procedures . MATERIAL AND METHODS One hundred and fifty-one subjects , who required single-tooth rehabilitation in the area of 15 - 25 and 35 - 45 , were enrolled in eight private clinics in Italy . The implant sites were r and omly allocated to one of the following treatment groups . In the control group , in which a st and ard preparation procedure for implant placement and submerged healing of the implant was used , abutment connection and loading of the implants were performed 3 months after installation . In the test group 1 , a st and ard preparation procedure for the implant placement and immediate functional loading of implant was carried out . In the test 2 group , however , a modified implant installation procedure ( osteotome technique ) was used followed by immediate functional loading of the implant . Clinical and radiographic examinations were performed at 3 and 12 months of follow-up at all sites . RESULTS Three implants ( 5.5 % ) from the test 2 group ( osteotome preparation ) and one ( 2 % ) from the test 1 group ( conventional drill preparation ) failed to integrate and were removed one and three months after implant installation . The mean marginal bone loss assessed at 12 months was 0.31 mm ( test 1 ) , 0.25 mm ( test 2 ) and 0.38 mm ( control ) ( no statistically significant differences were found between the three treatment groups . ) CONCLUSION It is suggested that immediate functional loading of implants that are placed with a conventional installation technique and with sufficient primary stability may be considered as a valid treatment alternative in a single-tooth replacement PURPOSE The primary goal of this stratified r and omized controlled trial ( S RCT ) was to compare the stability of dental implants placed under three different loading regimens during the first 16 weeks of healing following implant placement . Implants were loaded immediately , early ( 6 weeks ) , or with conventional/delayed timing ( 12 weeks ) . Secondary outcomes were to compare marginal bone adaptation for 3 years after placement . MATERIAL S AND METHODS Single posterior implant sites in the maxilla or m and ible were examined . The insertion torque value was the primary determinant of load assignment . Resonance frequency analysis was performed at follow-up appointments for the first 16 weeks ( with results provided as implant stability quotients [ ISQs ] ) . Marginal bone levels were assessed via radiographs . RESULTS Forty patients each received a single 4.0-mm diameter dental implant between 2004 and 2007 . One implant failure occurred in Lekholm and Zarb type 4 bone with insertion torque value ( ITV ) of < 8.1 Ncm ; the cumulative success rate was 97.5 % . All implants , when classified by bone and loading type , increased in stability over time , with a minor reduction of 1.3 ISQ units seen at 4 weeks in the immediate loading group . The mean marginal bone loss over 3 years was 0.22 mm . The mean ITVs at implant placement for bone types 1 and 2 ( grouped together ) , 3 , and 4 were 32 , 17 , and 10 , respectively , and were significantly different ( P < .05 ) . CONCLUSIONS ITV was a good objective measure of bone type . Using an ITV of 20 Ncm as the determinant for immediate loading and an ITV of 10 Ncm or greater as the determinant for early loading provided long-term success for this implant and led to no negative changes in tissue response . All bone type groups and loading groups showed no reduction in stability during the first 4 months of healing OBJECTIVES The aim of this clinical study was to determine the effectiveness of progressive loading procedures on preserving crestal bone height and improving peri-implant bone density around
Output:
| Overall there was no convincing evidence of a clinical ly important difference in prosthesis failure , implant failure , or bone loss associated with different loading times of implants . |
MS211472 | ***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 rogen-deprivation therapy is offered to men with prostate cancer who have a rising prostate-specific antigen after curative therapy ( PSA relapse ) or who are considered not suitable for curative treatment ; however , the optimal timing for its introduction is uncertain . We aim ed to assess whether immediate and rogen-deprivation therapy improves overall survival compared with delayed therapy . METHODS In this r and omised , multicentre , phase 3 , non-blinded trial , we recruited men through 29 oncology centres in Australia , New Zeal and , and Canada . Men with prostate cancer were eligible if they had a PSA relapse after previous attempted curative therapy ( radiotherapy or surgery , with or without postoperative radiotherapy ) or if they were not considered suitable for curative treatment ( because of age , comorbidity , or locally advanced disease ) . We used a data base-embedded , dynamically balanced , r and omisation algorithm , coordinated by the Cancer Council Victoria , to r and omly assign participants ( 1:1 ) to immediate and rogen-deprivation therapy ( immediate therapy arm ) or to delayed and rogen-deprivation therapy ( delayed therapy arm ) with a recommended interval of at least 2 years unless clinical ly contraindicated . R and omisation for participants with PSA relapse was stratified by type of previous therapy , relapse-free interval , and PSA doubling time ; r and omisation for those with non-curative disease was stratified by metastatic status ; and r and omisation in both groups was stratified by planned treatment schedule ( continuous or intermittent ) and treatment centre . Clinicians could prescribe any form and schedule of and rogen-deprivation therapy and group assignment was not masked . The primary outcome was overall survival in the intention-to-treat population . The trial closed to accrual in 2012 after review by the independent data monitoring committee , but data collection continued for 18 months until Feb 26 , 2014 . It is registered with the Australian New Zeal and Clinical Trials Registry ( ACTRN12606000301561 ) and Clinical Trials.gov ( NCT00110162 ) . FINDINGS Between Sept 3 , 2004 , and July 13 , 2012 , we recruited 293 men ( 261 with PSA relapse and 32 with non-curable disease ) . We r and omly assigned 142 men to the immediate therapy arm and 151 to the delayed therapy arm . Median follow-up was 5 years ( IQR 3·3 - 6·2 ) from the date of r and omisation . 16 ( 11 % ) men died in the immediate therapy arm and 30 ( 20 % ) died in the delayed therapy arm . 5-year overall survival was 86·4 % ( 95 % CI 78·5 - 91·5 ) in the delayed therapy arm versus 91·2 % ( 84·2 - 95·2 ) in the immediate therapy arm ( log-rank p=0·047 ) . After Cox regression , the unadjusted HR for overall survival for immediate versus delayed arm assignment was 0·55 ( 95 % CI 0·30 - 1·00 ; p=0·050 ) . 23 patients had grade 3 treatment-related adverse events . 105 ( 36 % ) men had adverse events requiring hospital admission ; none of these events were attributable to treatment or differed between treatment-timing groups . The most common serious adverse events were cardiovascular , which occurred in nine ( 6 % ) patients in the delayed therapy arm and 13 ( 9 % ) in the immediate therapy arm . INTERPRETATION Immediate receipt of and rogen-deprivation therapy significantly improved overall survival compared with delayed intervention in men with PSA-relapsed or non-curable prostate cancer . The results provide benchmark evidence of survival rates and morbidity to discuss with men when considering their treatment options . FUNDING Australian National Health and Medical Research Council and Cancer Councils , The Royal Australian and New Zeal and College of Radiologists , Mayne Pharma Australia BACKGROUND AND PURPOSE The ongoing Early Prostate Cancer ( EPC ) programme is assessing bicalutamide ( ' Casodex ' ) 150 mg , either alone or as adjuvant to treatment of curative intent , in patients with localised or locally advanced prostate cancer ( n=8113 ) . This paper presents an exploratory analysis of the subgroup of the EPC programme who received radiotherapy with curative intent ( n=1370 ) in order to determine the efficacy ( in terms of progression-free survival [ PFS ] ) and tolerability of bicalutamide 150 mg in this setting . PATIENTS AND METHODS 1370 patients with T1 - 4 , MO , any N prostate cancer received bicalutamide 150 mg or placebo adjuvant to radiotherapy of curative intent . This analysis was undertaken at median 5.3 years ' follow-up . RESULTS In patients with locally advanced disease ( n=305 ) , bicalutamide adjuvant to radiotherapy significantly increased PFS by 53 % ( event-time ratio 1.53 ; 95 % confidence intervals [ CI ] 1.16 , 2.02 ) compared with placebo and reduced the risk of disease progression by 42 % ( hazard ration [ HR ] 0.58 ; 95 % CI 0.41 , 0.84 ; P=0.00348 ) . In these patients , objective progression was experienced by 33.5 % of those r and omised to bicalutamide versus 48.6 % for those r and omised to placebo . The between-group difference in patients with localised disease ( n=1065 ) failed to reach statistical significance ( HR 0.80 ; 95 % CI 0.62 , 1.03 ; P=0.088 ) . The most common adverse events were breast pain ( 74.8 % ) and gynaecomastia ( 66.6 % ) , which were mild to moderate in > 90 % of cases . CONCLUSIONS Bicalutamide 150 mg/day given as adjuvant to radiotherapy significantly improved PFS in patients with locally advanced prostate cancer . For patients with localised disease , the results at this stage from the radiotherapy subgroup and the overall EPC programme suggest that adjuvant hormonal therapy is currently not appropriate . There were no unexpected tolerability findings PURPOSE To determine the potential advantage of and rogen ablation following st and ard external-beam radiation therapy in patients with locally advanced ( clinical or pathologic T3 ; clinical or pathologic node positive ) carcinoma of the prostate . METHODS AND MATERIAL S In 1987 the RTOG initiated a Phase III trial of long-term adjuvant goserelin in definitively irradiated patients with carcinoma of the prostate . A total of 977 patients were accrued to the study of which 945 remain analyzable : 477 on the adjuvant hormone arm ( Arm I ) ; and 468 on the radiation only arm ( Arm II ) with hormones initiated at relapse . The initial results were reported in the Journal of Clinical Oncology in 1997 . RESULTS With a median follow up of 5.6 years for all patients and 6.0 years for living patients local failure at 8 years was 23 % for Arm I and 37 % for Arm II ( p < 0.0001 ) . Distant metastasis was likewise favorably impacted with the immediate use of hormonal manipulation with a distant metastasis rate in Arm I of 27 % and 37 % in Arm II ( p < 0.0001 ) . Disease-free survival ( NED survival ) and NED survival with PSA of 1.5 ng/mL ( bNED ) or less were both statistically significant in favor of the immediate hormone arm ( both p < 0.0001 ) . Cause-specific failure was not statistically different with a cause-specific failure of 16 % for Arm I and 21 % in Arm II ( p = 0.23 ) . Overall survival was likewise not statistically different between two arms , with a 49 % overall survival at 8 years in Arm I and 47 % in Arm II ( p = 0.36 ) . Subset analysis of central ly review ed Gleason 8 - 10 patients who did not undergo prostatectomy showed that for patients receiving radiation therapy plus adjuvant hormones there was a statistically significant improvement in both absolute ( p = 0.036 ) and cause-specific survival ( p = 0.019 ) . CONCLUSIONS Use of long-term adjuvant and rogen deprivation in addition to definitive radiation therapy results in a highly significant improvement in regards to local control , freedom from distant metastasis , and biochemical free survival in unfavorable prognosis patients with carcinoma of the prostate PURPOSE We evaluated changes in bone mineral density ( BMD ) , fat-free mass ( FFM ) and serum lipid levels during bicalutamide 150 mg monotherapy compared with medical castration for 2 years . MATERIAL S AND METHODS A total of 103 men with localized or locally advanced prostate cancer ( T1-T4 , Nx , M0 ) for whom immediate and rogen deprivation was indicated were enrolled in this prospect i ve , multicenter , open-label , parallel group study . Patients were r and omized to bicalutamide 150 mg once daily ( 51 ) or medical castration with a luteinizing hormone releasing hormone analogue ( 52 ) for 96 weeks . Primary end points were mean percent change from baseline in lumbar spine BMD , hip BMD and FFM at 96 weeks . Mean changes in lipid parameters with time were also evaluated . RESULTS BMD was maintained during bicalutamide 150 mg monotherapy ( + 2.42 % for lumbar spine BMD and + 1.13 % for hip BMD at week 96 ) , while castration was associated with a progressive loss in BMD ( -5.40 % and -4.39 % at week 96 , respectively , both p < 0.0001 at week 96 ) . There was no significant difference between bicalutamide 150 mg and castration in mean percent change from baseline in FFM ( -1.56 % and -3.86 % , respectively , at week 96 , p = 0.31 ) , although there was a trend for greater progressive loss over time with castration . Mean changes in lipid parameters were small and similar in the 2 groups . CONCLUSIONS Bicalutamide 150 mg monotherapy may offer an important advantage compared to castration in terms of bone loss and body composition for patients who require long-term and rogen deprivation for localized or locally advanced prostate cancer CONTEXT Survival benefit in the management of high- grade clinical ly localized prostate cancer has been shown for 70 Gy radiation therapy combined with 3 years of and rogen suppression therapy ( AST ) , but long-term AST is associated with many adverse events . OBJECTIVE To assess the survival benefit of 3-dimensional conformal radiation therapy ( 3D-CRT ) alone or in combination with 6 months of AST in patients with clinical ly localized prostate cancer . DESIGN , SETTING , AND PATIENTS A prospect i ve r and omized controlled trial of 206 patients with clinical ly localized prostate cancer who were r and omized to receive 70 Gy 3D-CRT alone ( n = 104 ) or in combination with 6 months of AST ( n = 102 ) from December 1 , 1995 , to April 15 , 2001 . Eligible patients included those with a prostate-specific antigen ( PSA ) of at least 10 ng/mL , a Gleason score of at least 7 , or radiographic evidence of extraprostatic disease . MAIN OUTCOME MEASURES Time to PSA failure ( PSA > 1.0 ng/mL and increasing > 0.2 ng/mL on 2 consecutive visits ) and overall survival . RESULTS After a median follow-up of 4.52 years , patients r and omized to receive 3D-CRT plus AST had a significantly higher survival ( P = .04 ) , lower prostate cancer-specific mortality ( P = .02 ) , and higher survival free of salvage AST ( P = .002 ) . Kaplan-Meier estimates of 5-year survival rates were 88 % ( 95 % confidence interval [ CI ] , 80%-95 % ) in the 3D-CRT plus AST group vs 78 % ( 95 % CI , 68%-88 % ) in the 3D-CRT group . Rates of survival free of salvage AST at 5 years were 82 % ( 95 % CI , 73%-90 % ) in the 3D-CRT plus AST group vs 57 % ( 95 % CI , 46%-69 % ) in the 3D-CRT group . CONCLUSION The addition of 6 months of AST to 70 Gy 3D-CRT confers an overall survival benefit for patients with clinical ly localized prostate cancer To assess testosterone and haemoglobin kinetics in the Postoperative Adjuvant And rogen Deprivation ( PAAD ) trial , and correlate these with quality of life ( QoL ) in this prospect i ve r and omized study PURPOSE In a r and omized study we compared the combination of orchiectomy and radiotherapy to radiotherapy alone as treatment for locally advanced prostate cancer . Patients who were treated only with radiotherapy initially underwent castration therapy at clinical progression , providing the opportunity to compare immediate vs deferred endocrine intervention . MATERIAL S AND METHODS
Output:
| Early AST probably extends time to death of any cause and time to death from prostate cancer .
It may slightly decrease the rate of skeletal events .
Rates of serious adverse events and quality of life may be similar .
It may increase fatigue and may increase the risk of heart failure . |
MS211473 | ***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 Saeterbakken , AH and Fiml and , MS . Electromyographic activity and 6RM strength in bench press on stable and unstable surfaces . J Strength Cond Res 27(4 ) : 1101–1107 , 2013—The purpose of the study was to compare 6-repetition maximum ( 6RM ) loads and muscle activity in bench press on 3 surfaces , namely , stable bench , balance cushion , and Swiss ball . Sixteen healthy , resistance-trained men ( age 22.5 ± 2.0 years , stature 1.82 ± 6.6 m , and body mass 82.0 ± 7.8 kg ) volunteered for 3 habituation/strength testing sessions and 1 experimental session . In r and omized order on the 3 surfaces , 6RM strength and electromyographic activity of pectoralis major , deltoid anterior , biceps brachii , triceps brachii , rectus abdominis , oblique external and erector spinae were assessed . Relative to stable bench , the 6RM strength was approximately 93 % for balance cushion ( p ⩽ 0.001 ) and approximately 92 % for Swiss ball ( p = 0.008 ) ; the pectoralis major electromyographic ( EMG ) activity was approximately 90 % using the balance cushion ( p = 0.080 ) and approximately 81 % using Swiss ball ( p = 0.006 ) ; the triceps EMG was approximately 79 % using the balance cushion ( p = 0.028 ) and approximately 69 % using the Swiss ball ( p = 0.002 ) . Relative to balance cushion , the EMG activity in pectoralis , triceps , and erector spinae using Swiss ball was approximately 89 % ( p = 0.016 ) , approximately 88 % ( p = 0.014 ) and approximately 80 % ( p = 0.020 ) , respectively . In rectus abdominis , the EMG activity relative to Swiss ball was approximately 69 % using stable bench ( p = 0.042 ) and approximately 65 % using the balance cushion ( p = 0.046 ) . Similar EMG activities between stable and unstable surfaces were observed for deltoid anterior , biceps brachii , and oblique external . In conclusion , stable bench press had greater 6RM strength and triceps and pectoralis EMG activity compared with the unstable surfaces . These findings have implication s for athletic training and rehabilitation , because they demonstrate an inferior effect of unstable surfaces on muscle activation of prime movers and strength in bench press . If an unstable surface in bench press is desirable , a balance cushion should be chosen instead of a Swiss ball Antagonistic muscle pairs can not be fully activated simultaneously , even with maximal effort , under conditions of voluntary co-contraction , and their muscular activity levels are always below those during agonist contraction with maximal voluntary effort ( MVE ) . Whether the muscular activity level during the task has trainability remains unclear . The present study examined this issue by comparing the muscular activity level during maximal voluntary co-contraction for highly experienced bodybuilders , who frequently perform voluntary co-contraction in their training programs , with that for untrained individuals ( nonathletes ) . The electromyograms ( EMGs ) of biceps brachii and triceps brachii muscles during maximal voluntary co-contraction of elbow flexors and extensors were recorded in 11 male bodybuilders and 10 nonathletes , and normalized to the values obtained during the MVE of agonist contraction for each of the corresponding muscles ( % EMGMVE ) . The involuntary coactivation level in antagonist muscle during the MVE of agonist contraction was also calculated . In both muscles , % EMGMVE values during the co-contraction task for bodybuilders were significantly higher ( P<0.01 ) than those for nonathletes ( biceps brachii : 66±14 % in bodybuilders vs. 46±13 % in nonathletes , triceps brachii : 74±16 % vs. 57±9 % ) . There was a significant positive correlation between a length of bodybuilding experience and muscular activity level during the co-contraction task ( r = 0.653 , P = 0.03 ) . Involuntary antagonist coactivation level during MVE of agonist contraction was not different between the two groups . The current result indicates that long-term participation in voluntary co-contraction training progressively enhances muscular activity during maximal voluntary co-contraction Abstract The purpose of this study was to compare one-repetition maximum ( 1-RM ) and muscle activity in three chest-press exercises with different stability requirements ( Smith machine , barbell , and dumbbells ) . Twelve healthy , resistance-trained males ( age 22.7 ± 1.7 years , body mass 78.6 ± 7.6 kg , stature 1.80 ± 0.06 m ) were tested for 1-RM of the three chest-press exercises in counterbalanced order with 3–5 days of rest between the exercises . One-repetition maximum and electromyographic activity of the pectoralis major , deltoid anterior , biceps , and triceps brachii were recorded in the exercises . The dumbbell load was 14 % less than that for the Smith machine ( P ≤ 0.001 , effect size [ ES ] = 1.05 ) and 17 % less than that for the barbell ( P ≤ 0.001 , ES = 1.11 ) . The barbell load was ∼3 % higher than that for the Smith machine ( P = 0.016 , ES = 0.18 ) . Electrical activity in the pectoralis major and anterior deltoid did not differ during the lifts . Electrical activity in the biceps brachii increased with stability requirements ( i.e. Smith machine < barbell < dumbbells ; P ≤ 0.005 ; ES = 0.57 , 1.46 , and 2.00 , respectively ) , while triceps brachii activity was reduced using dumbbells versus barbell ( P = 0.007 , ES = 0.73 ) and dumbbells versus Smith machine ( P = 0.003 , ES = 0.62 ) . In conclusion , high stability requirements in the chest press ( dumbbells ) result in similar ( pectoralis major and anterior deltoid ) , lower ( triceps brachii ) or higher ( biceps brachii ) muscle activity . These findings have implication s for athletic training and rehabilitation The purpose s of this study were to assess : ( i ) the effects of 8-week training programs with constrained-path and unconstrained-path chest press machines on 1-RM ; ( ii ) the different activity patterns of selected arm and shoulder girdle muscles during push movement performed on the different machines ; ( iii ) the transfer of the training effects from one machine to the other . Twenty healthy , sedentary women ( mean+/-SD age , 24.8+/-1.0yrs ) , r and omized to either the FM or CM strength training protocol s were evaluated before and after the strength training program . Muscular activity signals were recorded by surface electromyography ( sEMG ) from eight muscles while each subject performed the exercise on each machine . Muscle strength was defined by a 1 repetition maximum ( 1-RM ) test for each subject on each machine . Both machines were effective in improving 1-RM , but the 1-RM increased more in the FM than the CM . Adaptive change in the sEMG was observed in all muscles after training on the FM machine , but not within the stabilizers when training on the CM machine . The results suggest that training in an unconstrained condition provides a more effective method for improving inter-muscular coordination via adaptation of the motor strategy aim ed at optimising muscular efforts Abstract Flanagan , SD , Mills , MD , Sterczala , AJ , Mala , J , Comstock , BA , Szivak , TK , DuPont , WH , Looney , DP , McDermott , DM , Hooper , DR , White , MT , Dunn-Lewis , C , Volek , JS , Maresh , CM , and Kraemer , WJ . The relationship between muscle action and repetition maximum on the squat and bench press in men and women . J Strength Cond Res 28(9 ) : 2437–2442 , 2014—The relationship between muscle action and fatigue is not well understood , especially in terms of potential sex-specific differences . The purpose of this investigation was to determine whether a different number of repetitions could be performed on the individual muscle actions of the bench press and squat in men and women . Ten resistance-trained men ( n = 10 ; age , 25.2 ± 1.2 years ; height , 178.6 ± 8.8 cm ; weight , 91.4 ± 18.1 kg ; body fat , 12.7 ± 3.6 % ) and women ( n = 10 ; age , 25.4 ± 2.4 years ; height , 164 ± 4.0 cm ; weight , 58.45 ± 3.3 kg ; body fat , 20.8 ± 1.5 % ) participated in this balanced and r and omized within-group study . Using 85 % of a 1 repetition maximum , over the course of 3 visits , subjects performed 1 eccentric ( ECC ) , concentric ( CON ) , or combined ( COMB ) set to failure on the squat and bench press . Differences in muscle action and sex-specific number of repetitions to failure were compared on the squat and bench press , where significance was p ⩽ 0.05 . Across both exercises and sex , we observed significant differences between each of the 3 muscle actions , where the number of repetitions decreased from ECC to COMB to CON . While no sex-specific differences were observed in the squat , women performed significantly more repetitions on the ECC and CON muscle actions of the bench press . Men performed more combined repetitions , however , indicating a greater reliance on the stretch-shortening cycle . Different muscle actions contribute uniquely to the successful performance of a lift and fatigue . These contributions appear to differ in men and women Clark , RA , Humphries , B , Hohmann , E , and Bryant , AL . The influence of variable range of motion training on neuromuscular performance and control of external loads . J Strength Cond Res 25(3 ) : 704 - 711 , 2011-Resistance training programs that emphasize high force production in different regions of the range of motion ( ROM ) may provide performance benefits . This study examined whether variable ROM ( VROM ) training , which consists of partial ROM training with countermovements performed in a different phase of the ROM for each set , results in improved functional performance . Twenty-two athletes ( age 22.7 ± 2.4 years , height 1.81 ± 0.07 m , and body mass 94.6 ± 14.5 kg ) with extensive resistance training background s performed either a VROM or full ROM control ( CON ) 5-week , concentric work-matched training program . The participants were assigned to a group based on stratified r and omization incorporating their strength levels and performance gains in preceding training microcycles . Testing consisted of assessing the force-ROM relationship during isokinetic and isometric bench press and ballistic bench throws , with normalized electromyography amplitude assessed during the isometric tests . Repeated-measure analyses of variance revealed that the VROM intervention significantly ( p < 0.05 ) increased both full ROM bench throw displacement ( + 15.5 % ) and half ROM bench throw peak force ( + 15.7 % ) , in addition to isokinetic peak force in the terminal ROM ( 13.5 % increase ) . No significant differences were observed in the CON group or between groups for any other outcome measures . Analysis of the force-ROM relationship revealed that that the VROM intervention enhanced performance at shorter muscle lengths . These findings suggest that VROM training improves terminal and midrange performance gains , result ing in the athlete possessing an improved ability to control external loading and produce dynamic force Abstract Calatayud , J , Borreani , S , Colado , JC , Martin , F , Tella , V , and And ersen , LL . Bench press and push-up at comparable levels of muscle activity results in similar strength gains . J Strength Cond Res 29(1 ) : 246–253 , 2015—Electromyography ( EMG ) exercise evaluation is commonly used to measure the intensity of muscle contraction . Although research ers assume that biomechanically comparable resistance exercises with similar high EMG levels will produce similar strength gains over the long term , no studies have actually corroborated this hypothesis . This study evaluated EMG levels during 6 repetition maximum ( 6RM ) bench press and push-up , and subsequently performed a 5-week training period where subjects were r and omly divided into 3 groups ( i.e. , 6RM bench press group , 6RM elastic b and push-up group , or control group ) to evaluate muscle strength gains . Thirty university students with advanced resistance training experience participated in the 2-part study . During the training period , exercises were performed using the same loads and variables that were used during the EMG data collection . At baseline , EMG amplitude showed no significant difference between 6RM bench press and b and push-up . Significant differences among the groups were found for percent change ( & Dgr ; ) between pretest and posttest for 6RM ( p = 0.017 ) and for 1 repetition maximum ( 1RM ) ( p < 0.001 ) . Six repetition maximum bench press group and 6RM elastic b and push-up group improved their 1RM and 6RM ( & Dgr ; ranging from 13.65 to 22.21 ) tests significantly with similar gains , whereas control group remains unchanged . Thus , when the EMG values are comparable and the same conditions are reproduced , the aforementioned exercises can
Output:
| The triceps brachii ( TB ) and pectoralis major ( PM ) muscles were found to have similar activity during the BP , which was significantly higher than the activity of the anterior deltoid .
During the BP movement , muscle activity changes with exercise intensity , velocity of movement , fatigue , mental focus , movement phase and stability conditions , such as bar vibration or unstable surfaces .
Under these circumstances , TB is the most common object of activity change .
PM and TB EMG activity is more dominant and shows greater EMG amplitude than anterior deltoid during the BP .
There are six factors that can influence muscle activity during the BP ; however , the most important factor is exercise intensity , which interacts with all other factors . |
MS211474 | ***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 — The relationship between the dose of recombinant tissue-type plasminogen activator ( r-tPA ) and its safety/efficacy for ischemic stroke has not been well evaluated in the East Asian population . We assessed the safety/efficacy of different doses of r-tPA for acute ischemic stroke in Chinese patients . Methods — A total of 1004 eligible patients were classified according to the dose of r-tPA received for managing acute ischemic stroke : 0.9 mg/kg ( n=422 ) , 0.8 mg/kg ( n=202 ) , 0.7 mg/kg ( n=199 ) , and 0.6 mg/kg ( n=181 ) . The safety outcome was symptomatic intracerebral hemorrhage and death within 3 months . The efficacy outcome was good functional outcome ( modified Rankin Scale ⩽1 ) at 3 months . Results — There was a significant trend for symptomatic intracerebral hemorrhage with age ( P=0.002 ) . With multivariate logistic regression analysis , a dose of 0.9 mg/kg was a predictor of symptomatic intracerebral hemorrhage ( P=0.0109 ) , and a dose ⩽0.65 mg/kg was a predictor of good functional outcome ( P=0.0369 ) . In patients aged 71 to 80 years , there was a significant trend of increasing symptomatic intracerebral hemorrhage ( P=0.0130 ) and less good functional outcome ( P=0.0179 ) with increasing doses of r-tPA . There was also a trend of increasing mortality ( P=0.0971 ) at 3 months in these patients . Conclusions — These results did not support the dose of 0.9 mg/kg of r-tPA being optimal for all patients in the East Asian population . In elderly patients ( 71–80 years ) , a lower dose of 0.6 mg/kg is associated with a better outcome . Confirmation of the results through r and omized trial is required Background and Purpose — The purpose of this study was to evaluate further the efficacy of 0.6 mg/kg intravenous alteplase on vascular and clinical outcomes in patients with middle cerebral artery occlusion in a postmarketing Phase IV trial of prospect i ve cohort study design . Methods — Alteplase was given intravenously at 0.6 mg/kg to patients with ischemic stroke within 3 hours of onset with MR angiography-documented middle cerebral artery occlusion . Vascular outcome was evaluated by MR angiography at 6 and 24 hours after symptom onset based on the modified Mori grade . The primary end points also included a favorable outcome ( modified Rankin Scale 0 to 1 at 3 months after onset ) and incidence of symptomatic intracranial hemorrhage within 36 hours after treatment . The impact of recanalization on clinical outcome was assessed by stepwise logistic regression analysis . Results — Fifty-eight patients were enrolled . Recanalization was noted in 51.7 % on 6-hour MR angiography and 69.0 % on 24-hour MR angiography . A favorable clinical outcome was achieved in 46.6 % . None had symptomatic intracranial hemorrhage . In logistic regression models , recanalization on either 6-hour or 24-hour MR angiography was an independent predictor for clinical outcome as well as the baseline National Institutes of Health Stroke Scale score . Conclusions — Early recanalization of an occluded middle cerebral artery can be provoked by 0.6 mg/kg intravenous alteplase and may induce a favorable clinical outcome . The rates of recanalization and favorable outcome are comparable to that previously reported with the 0.9-mg/kg dose Background —Arterial recanalization precedes clinical improvement or may lead to hemorrhage or reperfusion injury . Speed of clot lysis was not previously measured in human stroke . Methods and Results —Transcranial Doppler ( TCD ) and the National Institutes of Health Stroke Scale ( NIHSS ) were used to monitor consecutive patients receiving intravenous tissue plasminogen activator ( tPA ) , before tPA bolus and at 24 hours . Patients with complete or partial recanalization of the middle cerebral or basilar artery on TCD were studied . Recanalization was classified a priori as sudden ( abrupt appearance of a normal or stenotic low-resistance signal ) , stepwise ( flow improvement over 1 to 29 minutes ) , or slow ( ≥30 minutes ) . Recanalization was documented in 43 tPA-treated patients ( age 68±17 years ; NIHSS score 16.8±6 , median 15 points ) . tPA bolus was given at a mean of 135±61 minutes after symptom onset . Recanalization began at a median of 17 minutes and was completed at 35 minutes after tPA bolus , with mean duration of recanalization of 23±16 minutes . Recanalization was sudden in 5 , stepwise in 23 , and slow in 15 patients . Faster recanalization predicted better short-term improvement ( P = 0.03 ) . At 24 hours , 80 % , 30 % , and 13 % of patients in these respective recanalization groups had NIHSS scores of 0 to 3 . Symptomatic hemorrhage occurred in only 1 patient , who had stepwise recanalization 5.5 hours after stroke onset . Slow or partial recanalization with dampened flow signal was found in 53 % of patients with total NIHSS scores > 10 points at 24 hours ( P = 0.01 ) . Complete recanalization ( n=25 ) occurred faster ( median 10 minutes ) than partial recanalization ( n=18 ; median 30 minutes;P = 0.0001 ) . Conclusions —Rapid arterial recanalization is associated with better short-term improvement , mostly likely because of faster and more complete clot breakup with low resistance of the distal circulatory bed . Slow ( ≥30 minutes ) flow improvement and dampened flow signal are less favorable prognostic signs . These findings may be evaluated to assist with selection of patients for additional pharmacological or interventional treatment OBJECTIVES To assess time management of stroke thrombolysis triage and functional outcomes in patients receiving recombinant tissue plasminogen activator for hyperacute stroke , and identify bottlenecks in delivery of the treatment . DESIGN Prospect i ve study . SETTING A university teaching hospital in Hong Kong . PATIENTS Patients with suspected hyperacute stroke referred to the stroke thrombolysis team during October 2008 to September 2009 . MAIN OUTCOME MEASURES Time performance records including door-to-stroke team , door-to-needle , and onset-to-thrombolysis times . Functional outcomes by modified Rankin Scale score at 3 months , and thrombolysis-related complications including haemorrhagic transformations and mortality . RESULTS During the 12-month period , 95 thrombolysis calls were received ; recombinant tissue plasminogen activator was given intravenously to 17 ( 18 % ) of the patients and intra-arterially to 11 ( 12 % ) . The mean ( st and ard deviation ) door-to-stroke team and the door-to-needle times for intravenous recombinant tissue plasminogen activator patients were 33 ( 25 ) and 80 ( 25 ) minutes , respectively ; both were about 20 minutes longer than that recommended by the National Institute of Neurological Disorders and Stroke . The mean National Institute of Health Stroke Scale score for patients received intravenous recombinant tissue plasminogen activator was 16 ( st and ard deviation , 7 ) . The mean ( st and ard deviation ) onset-to-treatment time was 144 ( 42 ) minutes . Nine ( 53 % ) patients who received intravenous recombinant tissue plasminogen activator achieved favourable outcomes at 3 months , with a modified Rankin Scale score of 0 to 1 . Symptomatic haemorrhage and mortality occurred in one ( 6 % ) patient . CONCLUSION A dedicated stroke triage pathway is essential to ensure efficient and safe delivery of thrombolysis therapy . Improvements in door-to-stroke team time through integration with emergency medicine staff and neuroradiologists may improve thrombolysis eligibility Background and Purpose — In Japan , alteplase at 0.6 mg/kg was approved in October 2005 for use within 3 hours of stroke onset by the Ministry of Health , Labor and Welfare ( MHLW ) . The aim of the Japan post-Marketing Alteplase Registration Study ( J-MARS ) , which was requested by MHLW at the time of approval , was to assess the safety and efficacy of 0.6 mg/kg alteplase in routine clinical practice for the Japanese . Methods — A total of 7492 patients from 942 centers were enrolled in the J-MARS , an open-label , nonr and omized , observational study , from October 2005 to October 2007 . Primary outcome measures were symptomatic intracranial hemorrhage ( a deterioration in NIHSS score ≥4 from baseline ) and favorable outcome ( modified Rankin Scale score , 0–1 ) at 3 months after stroke onset . Results — The proportion of patients with symptomatic intracranial hemorrhage in 7492 patients ( safety analysis ) was 3.5 % ( 95 % confidence interval [ CI ] , 3.1%–3.9 % ) within 36 hours and 4.4 % ( 95 % CI , 3.9%–4.9 % ) at 3 months . The overall mortality rate was 13.1 % ( 95 % CI , 12.4%–13.9 % ) and the proportion of patients with fatal symptomatic intracranial hemorrhage was 0.9 % ( 95 % CI , 0.7%–1.2 % ) . The outcomes at 3 months were available for 4944 patients and the proportion of favorable outcome ( efficacy analysis ) was 33.1 % ( 95 % CI , 31.8%–34.4 % ) . The subgroup analysis in patients between 18 and 80 years with a baseline NIHSS score < 25 demonstrated that favorable outcome at 3 months was 39.0 % ( 95 % CI , 37.4%–40.6 % ) . Conclusions — These data suggest that 0.6 mg/kg intravenous alteplase within 3 hours of stroke onset could be safe and effective in routine clinical practice for the Japanese Background and Purpose — The safety and efficacy of alteplase for ischemic stroke has not been examined in Chinese patients . We assessed the safety and efficacy of alteplase for acute ischemic stroke in daily clinical practice in Taiwan . Methods — A prospect i ve , multicenter , observational study was conducted in Taiwan from December 2004 to July 2008 . Eligible patients ( 241 ) receiving alteplase were recruited and divided into 2 groups : st and ard dose ( 0.90±0.02 mg/kg , n=125 ) and lower dose ( 0.72±0.07 mg/kg , n=116 ) . Primary outcome measures were safety : symptomatic intracerebral hemorrhage and death within 3 months . The secondary outcome measure was efficacy a modified Rankin scale of 0 to 2 after 3 months . Results — The st and ard-dose group had higher rates of symptomatic intracerebral hemorrhage using National Institute of Neurological Diseases and Stroke , European Cooperative Acute Stroke Study , and Safe Implementation of Thrombolysis in Stroke-Monitoring Study definitions ( 10.4 % versus 5.2 % , 8.0 % versus 2.6 % , and 5.6 % versus 1.7 % , respectively ) and mortality within 3 months ( 12.8 % versus 6.9 % ) , twice that of the lower-dose group . This pattern was more prominent in older patients . Significantly higher rates of symptomatic intracerebral hemorrhage per European Cooperative Acute Stroke Study ( 15.4 % versus 3.3 % , P=0.0257 ) and mortality ( 21.1 % versus 5.0 % , P=0.0099 ) and significantly lower independence rate ( 32.6 % versus 53.6 % , P=0.0311 ) were observed among patients ≥70 years old receiving the st and ard dose than those receiving the lower dose . Conclusions — This study suggests that the st and ard dose of 0.9 mg/kg alteplase may not be optimal for treating aged Chinese patients . However , the dose of recombinant tissue plasminogen activator for ischemic stroke in Chinese patients should be based on more broad and convincing evidence s and r and omized trials of lower versus higher doses are needed Background and Purpose — Based on previous studies comparing different recombinant tissue plasminogen activator ( rt-PA ) doses , we performed a clinical trial with 0.6 mg/kg , which is lower than the internationally approved dosage of 0.9 mg/kg , aim ing to assess the efficacy and safety of alteplase in acute ischemic stroke for the Japanese . Methods — Our prospect i ve , multicenter , single-arm , open-label trial was design ed with a target sample size of 100 patients . The primary end points were the proportion of patients with a modified Rankin Scale ( mRS ) score of 0 to 1 at 3 months and the incidence of symptomatic intracranial hemorrhage ( sICH ) within 36 hours . Thresholds
Output:
| The results remained consistent when sensitivity analyses were performed including only low-dose and st and ard-dose rtPA or only Asian studies .
Our review shows small difference between the outcomes or the risk profile in the studies using low-dose and /or st and ard-dose rtPA for AIS .
Low-dose rtPA was not associated with lower risk of death or disability , death alone , or sICH |
MS211475 | ***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 Dexketoprofen trometamol plus tramadol hydrochloride is a new oral combination of two analgesics , which have different mechanisms of action for the treatment of moderate to severe acute pain . Methods R and omised , double-blind , parallel , placebo and active-controlled , single and multiple-dose study to evaluate the analgesic efficacy and safety of dexketoprofen/tramadol 25 mg/75 mg in comparison with the single agents ( dexketoprofen 25 mg and tramadol 100 mg ) in moderate to severe acute pain after abdominal hysterectomy . Patients received seven consecutive doses of study drug within a 3-day period , each dose separated by an 8-hour interval . A placebo arm was included during the single-dose phase to vali date the pain model . Efficacy assessment s included pain intensity , pain relief , patient global evaluation and use of rescue medication . The primary endpoint was the mean sum of pain intensity differences over the first 8 h ( SPID8 ) . Results The efficacy analysis included 606 patients , with a mean age of 48 years ( range 25–73 ) . The study results confirmed the superiority of the combination over the single agents in terms of the primary endpoint ( p < 0.001 ) . Secondary endpoints were generally supportive of the superiority of the combination for both single and multiple doses . Most common adverse drug reactions ( ADRs ) were nausea ( 4.6 % ) and vomiting ( 2.3 % ) . All other ADRs were experienced by less than 2 % of patients . Conclusions The study results provided robust evidence of the superiority of dexketoprofen/tramadol 25 mg/75 mg over the single components in the management of moderate to severe acute pain , as confirmed by the single-dose efficacy , repeated-dose sustained effect and good safety profile observed . Trial registration EU Clinical Trials Register ( EudraCT number 2012 - 004545 - 32 , registered 04 October 2012 ) ; Clinical trials.gov ( NCT01904149 , registered 17 July 2013 ) 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 Background . The aim was to evaluate the analgesic efficacy and safety of the dexketoprofen/tramadol 25 mg/75 mg fixed-dose combination vs dexketoprofen ( 25 mg ) and tramadol ( 100 mg ) in moderate-to-severe acute pain after total hip arthroplasty . Methods . This was a r and omized , double-blind , parallel-group study in patients experiencing pain of at least moderate intensity on the day after surgery , compared with placebo at first administration to vali date the pain model . The study drug was administered orally every 8 h throughout a 5 day period . Rescue medication , metamizole 500 mg , was available during the treatment period . The evaluation of efficacy was based on patient assessment s of pain intensity and pain relief . The primary end point was the mean sum of the pain intensity difference values throughout the first 8 h ( SPID8 ) . Results . Overall , 641 patients , mean age 62 ( range 29–80 ) yr , were analysed ; mean ( sd ) values of SPID8 were 247 ( 157 ) for dexketoprofen/tramadol , 209 ( 155 ) for dexketoprofen , 205 ( 146 ) for tramadol , and 151 ( 159 ) for placebo . The primary analysis confirmed the superiority of the combination over dexketoprofen 25 mg ( P=0.019 ; 95 % confidence interval 6.4–73 ) and tramadol 100 mg ( P=0.012 ; 95 % confidence interval 9.5–76 ) . The single components were superior to placebo ( P<0.05 ) , confirming model sensitivity . Most secondary analyses supported the superiority of the combination . The incidence of adverse drug reactions was low and similar among active treatment groups . Conclusion . The efficacy results confirmed the superiority of dexketoprofen/tramadol over its single components , even at higher doses ( tramadol ) , with a safety profile fully in line with that previously known for these agents in monotherapy . Clinical trial registration . EudraCT 2012 - 004548 - 31 ( https://www . clinical trialsregister.eu/ctr- search / search ? query = eudract_number:2012 - 004548 - 31 ) ; Clinical Trials.gov NCT01902134 ( https://www . clinical trials.gov/ct2/show/NCT01902134?term=NCT01902134&rank=1 ) Background Combination analgesics are effective in acute pain , and a theoretical framework predicts efficacy for combinations . The combination of dexketoprofen and tramadol is untested , but predicted to be highly effective . Methods This was a r and omised , double-blind , double-dummy , parallel-group , placebo-controlled , single-dose trial in patients with moderate or severe pain following third molar extraction . There were ten treatment arms , including dexketoprofen trometamol ( 12.5 mg and 25 mg ) and tramadol hydrochloride ( 37.5 mg and 75 mg ) , given as four different fixed combinations and single components , with ibuprofen 400 mg as active control as well as a placebo control . The study objective was to evaluate the superior analgesic efficacy and safety of each combination and each single agent versus placebo . The primary outcome was the proportion of patients with at least 50 % max TOTPAR over six hours . Results 606 patients were r and omised and provided at least one post-dose assessment . All combinations were significantly better than placebo . The highest percentage of responders ( 72 % ) was achieved in the dexketoprofen trometamol 25 mg plus tramadol hydrochloride 75 mg group ( NNT 1.6 , 95 % confidence interval 1.3 to 2.1 ) . Addition of tramadol to dexketoprofen result ed in greater peak pain relief and greater pain relief over the longer term , particularly at times longer than six hours ( median duration of 8.1 h ) . Adverse events were unremarkable . Conclusions Dexketoprofen trometamol 25 mg combined with tramadol hydrochloride 75 mg provided good analgesia with rapid onset and long duration in a model of moderate to severe pain . The results of the dose finding study are consistent with pre-trial calculations based on empirical formulae . Trial registration EudraCT ( 2010 - 022798 - 32 ) ; Clinical trials.gov ( NCT01307020 ) & 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 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 & NA ; Reports of RCTs of analgesics frequently describe results of studies in the form of mean derived indices , rather than using discontinuous events — such as number or proportion of patients with 50 % pain relief . Because mean data inadequately describe information with a non‐normal distribution , combining mean data in systematic review s may compromise the results . Showing that dichotomous data can reliably be derived from mean data , at least in acute pain models , indicates that more meaningful overviews or meta‐ analysis may be possible . This study investigated the relationship between continuous and dichotomous analgesic measures in a set of individual patient data , and then used that relationship to derive dichotomous from continuous information in r and omised controlled trials ( RCTs ) of analgesics . Individual patient information from 13 RCTs of parallel‐group and crossover design in acute postoperative pain was used to calculate the percentage of the maximum possible pain relief score ( % maxTOTPAR ) and the proportion of patients with greater than 50 % pain relief ( > 50%maxTOTPAR ) for the different treatments . The relationship between the measures was investigated in 45 actual treatments and 10 000 treatments simulated using the underlying actual distribution ; 1283 patients had 45 separate treatments . Mean % maxTOTPAR correlated with the proportion of patients with > 50%maxTOTPAR ( r2 = 0.90 ) . The relationship calculated from all the 45 treatments predicted to within three patients the number of patients with more than 50 % pain relief in 42 of 45 treatments , and 98.8 % of 10 000 simulated treatments . For seven effective treatments , actual numbers‐needed‐to‐treat ( NNT ) to achieve > 50%maxTOTPAR compared with placebo were very similar to those derived from calculated data Abstract One way to ensure adequate sensitivity for analgesic trials is to test the intervention on patients who have established pain of moderate to severe intensity . The usual criterion is at least moderate pain on a categorical pain intensity scale . When visual analogue scales ( VAS ) are the only pain measure in trials we need to know what point on a VAS represents moderate pain , so that these trials can be included in meta‐ analysis when baseline pain of at least moderate intensity is an inclusion criterion . To investigate this we used individual patient data from 1080 patients from r and omised controlled trials of various analgesics . Baseline pain was measured using a 4‐point categorical pain intensity scale and a pain intensity VAS under identical conditions . The distribution of the VAS scores was examined for 736 patients reporting moderate pain and for
Output:
| We down grade d the evidence because it was not possible to estimate the effect exactly in the two multiple dose studies , result ing in imprecision .
Adverse events and serious adverse events were not reported consistently for the single dose phase of the studies .
Rates were lower with placebo and lower doses ( very low quality evidence ) .
Information on multiple dosing over three and five days supported a low event rate with the combination .
Overall , rates were generally low in all treatment arms , as they were for withdrawals for adverse events or other reasons .
A single oral dose of dexketoprofen 25 mg plus tramadol 75 mg provided good levels of pain relief with long duration of action to more people than placebo or the same dose of dexketoprofen or tramadol alone .
The magnitude of the effect was similar to other good analgesics .
Adverse event rates were low .
There is modest uncertainty about the precision of the point estimate for efficacy , but the NNT of 3 is consistent with other analgesics considered effective and commonly used |
MS211476 | ***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: BASIS Hyperlipidemia associated to nephrotic syndrome has been involved in the deterioration of the renal function in these patients . The reduction in the synthesis of cholesterol with pravastatin , an hydrophilic inhibitor of such synthesis , may improve both the dyslipemia , the renal function and the proteinuria . METHODS We conducted a controlled open r and omized study in 16 patients with proteinuria greater than 2 g/day , creatinine clearance greater than 0.5 ml/s ( 30 ml/min ) and hypercholesterolemia with LDL cholesterol greater than 4.9 mmol/l ( 190 mg/dl ) distributed in two groups . One of these groups received hypolipemiant dietetic treatment and 20 - 40 mg of pravastatin and the other group , only the dietetic treatment . RESULTS The patients receiving pravastatin showed a 27 % decrease in total plasmatic cholesterol , compared to a 6.7 % in the control group ( p < 0.01 ) . This decrease was more evident in the LDL cholesterol fraction ( 44 vs 9 % ; p < 0.01 ) . No significant modifications were observed in the HDL cholesterol fraction , triglycerides , renal function or proteinuria . Neither clinical nor enzymatiz adverse effects from hepatic or muscular origin were observed Background : Little is known about statins in the prevention of dyslipidaemia induced renal function decline . The secondary coronary heart disease ( CHD ) prevention GREACE study suggested that dose titration with atorvastatin ( 10–80 mg/day , mean dose 24 mg/day ) achieves the national cholesterol educational programme treatment goals and significantly reduces morbidity and mortality , compared with usual care . Aims : To report the effect of statin on renal function compared with untreated dyslipidaemia in both treatment groups . Methods / Results : All patients had plasma creatinine values within the reference range < 115 µmol/litre ( 13 mg/litre ) . The on study creatinine clearance ( CrCl ) , as estimated ( for up to 48 months ) by the Cockroft-Gault formula , was compared within and between treatment groups using analysis of variance to assess differences over time . Patients from both groups not treated with statins ( 704 ) showed a 5.2 % decrease in CrCl ( p < 0.0001 ) . Usual care patients on various statins ( 97 ) had a 4.9 % increase in CrCl ( p = 0.003 ) . Structured care patients on atorvastatin ( 783 ) had a 12 % increase in CrCl ( p < 0.0001 ) . This effect was more prominent in the lower two quartiles of baseline CrCl and with higher atorvastatin doses . After adjustment for 25 predictors of all CHD related events , multivariate analysis revealed a hazards ratio of 0.84 ( confidence interval 0.73 to 0.95 ; p = 0.003 ) with every 5 % increase in CrCl . Conclusions : In untreated dyslipidaemic patients with CHD and normal renal function at baseline , CrCl declines over a period of three years . Statin treatment prevents this decline and significantly improves renal function , potentially off setting an additional factor associated with CHD risk Proteinuria is an important risk factor for cardiovascular and renal morbidity and mortality . The effects of 3-hydroxy-3-methyglutaryl coenzyme A reductase inhibitor ( statin ) therapy on proteinuria in normolipidemic patients with well-controlled hypertension have not been studied . A total of 63 normolipidemic ( total cholesterol < 240 mg/dL ) and proteinuric ( 300 to 3000 mg/d ) patients with well-controlled blood pressure ( < 140/90 mm Hg ) were r and omized to receive either placebo ( n=32 ) or pravastatin ( 10 mg/d ; n=31 ) after a 3-month placebo period . Pravastatin lowered proteinuria after 6 months by 54 % ( P < 0.0001 ) . Creatinine clearance was stable throughout the study in the 2 groups . Despite unchanged plasma endothelin-1 levels throughout the study , urinary excretion of the peptide was decreased and significantly correlated with improvement in urinary protein excretion in pravastatin-treated patients ( r = 0.64 , P = 0.001 ) . The urinary excretion of retinol-binding protein decreased after pravastatin administration , probably reflecting an improvement in tubular function . In contrast , the urinary excretion of IgG did not change significantly throughout the study in either group . Multivariate analysis revealed that proteinuria was only significantly correlated with statin use ( P < 0.0001 , R2= 0.66 ) . Linear regression analysis in the statin-treated group did not show any correlation between changes in lipid profiles and proteinuria regression . Thus , in addition to their primary function of antilipidemia , the addition of pravastatin to treatment for well-controlled hypertension may have an additive effect on reducing proteinuria independent of hemodynamics and lipid-lowering effects , possibly through inhibiting renal endothelin-1 synthesis and improving tubular function Background —Microalbuminuria is associated with increased risk of cardiovascular events . We assessed whether therapeutic intervention aim ed at lowering urinary albumin excretion would reduce cardiovascular events in microalbuminuric subjects ( 15 to 300 mg/24 hours ) . Methods and Results —From the Prevention of Renal and Vascular Endstage Disease ( PREVEND ) cohort ( n=8592 ) , 1439 subjects fulfilled the inclusion criteria of the PREVEND Intervention Trial ( PREVEND IT ) . Of these subjects , 864 were r and omized to fosinopril 20 mg or matching placebo and to pravastatin 40 mg or matching placebo . The mean follow-up was 46 months , and the primary end point was cardiovascular mortality and hospitalization for cardiovascular morbidity . Mean age was 51±12 years ; 65 % of subjects were male , and 3.4 % had a previous cardiovascular event . Mean cholesterol level was 5.8±1.0 mmol/L , mean systolic/diastolic blood pressure was 130±18/76±10 mm Hg , and median urinary albumin excretion was 22.8 ( 15.8 to 41.3 ) mg/24 hours . The primary end point occurred in 45 subjects ( 5.2 % ) . Fosinopril reduced urinary albumin excretion by 26 % ( P<0.001 ) . Subjects treated with fosinopril showed a 40 % lower incidence of the primary end point ( hazard ratio 0.60 [ 95 % CI 0.33 to 1.10 ] , P=0.098 , log-rank ) . Pravastatin did not reduce urinary albumin excretion , and subjects treated with pravastatin showed a 13 % lower incidence of the primary end point than subjects in the placebo group ( 0.87 [ 0.49 to 1.57 ] , P=0.649 , log-rank ) . Conclusions —In microalbuminuric subjects , treatment with fosinopril had a significant effect on urinary albumin excretion . In addition , fosinopril treatment was associated with a trend in reducing cardiovascular events . Treatment with pravastatin did not result in a significant reduction in urinary albumin excretion or cardiovascular events Summary The effect of simvastatin ( 10–20 mg/day ) on kidney function , urinary albumin excretion rate and insulin sensitivity was evaluated in 18 Type 2 ( non-insulin-dependent ) diabetic patients with microalbuminuria and moderate hypercholesterolaemia ( total cholesterol ≥5.5 mmol·l−1 ) . In a double-blind , r and omized and placebo-controlled design treatment with simvastatin ( n=8 ) for 36 weeks significantly reduced total cholesterol ( 6.7±0.3 vs 5.1 mmol·l−1 ( p<0.01 ) ) , LDL-cholesterol ( 4.4±0.3 vs 2.9±0.2 mmol·l−1 ( p<0.001 ) ) and apolipoprotein B ( 1.05±0.04 vs 0.77±0.02 mmol·l−1 ( p<0.01 ) ) levels as compared to placebo ( n=10 ) . Both glomerular filtration rate ( mean±SEM ) ( simvastatin : 96.6±8.0 vs 96.0±5.7 ml·min−1·1.73 m−2 , placebo : 97.1±6.7 vs 88.8±6.0 ml·min−1·1.73 m−2 ) ( NS ) and urinary albumin excretion rate ( geometric mean x/÷ antilog SEM ) ( simvastatin : 18.4x/÷1.3vs 16.2 x/÷1.2 μg·min−1 , placebo 33.1 x/÷ 1.3 vs 42.7 x/÷ 1.3 μg·min−1)(NS ) were unchanged during the study . A euglycaemic hyperinsulinaemic clamp was performed at baseline and after 18 weeks in seven simvastatin- and nine placebo-treated patients . Isotopically determined basal and insulin-stimulated glucose disposal was similarly reduced before and during therapy in both the simvastatin ( 2.0±0.1 vs 1.9±0.1 ( NS ) and 3.1±0.6 vs 3.1±0.7 mg·kg−1·min−1 ( NS ) ) and the placebo group ( 1.9±0.1 vs 1.8±0.1 ( NS ) and 4.1±0.6 vs 3.8±0.2 mg·kg−1·min−1 ( NS ) ) . No different was observed in glucose storage or glucose and lipid oxidation before and after treatment . Further , the suppression of hepatic glucose production during hyperinsulinaemia was not influenced by simvastatin ( −0.7±0.8 vs −0.7±0.5 mg·kg−1·min−1 ( NS ) ) . In conclusion , despite marked improvement in the dyslipidaemia simvastatin had no impact on kidney function or urinary albumin excretion rate and did not reduce insulin resistance in these microalbuminuric and moderately hypercholesterolaemic Type 2 diabetic patients BACKGROUND In animal models , HMG-CoA reductase inhibitors were able to improve renal function and endothelium-dependent vascular reactivity . In various experimental renal diseases , including autosomal dominant polycystic kidney disease ( ADPKD ) , HMG-CoA reductase inhibitors improved the rate of decline in renal function . We studied the effect of simvastatin on ADPKD patients . METHODS In a double-blind cross-over study , 10 normocholesterolaemic ADPKD patients were treated in r and om order for 4 weeks with 40 mg simvastatin or placebo daily . After each treatment period , we investigated the effect of simvastatin on renal blood flow and endothelium-dependent vascular reactivity . These periods were separated by a 4-week wash-out period . RESULTS After treatment with simvastatin , glomerular filtration rate ( GFR ) significantly increased from 124+/-4 ml/min to 132+/-6 ml/min ( P<0.05 ) . Simultaneously , effective renal plasma flow ( ERPF ) increased significantly from 494+/-30 ml/min to 619+/-67 ml/min after simvastatin treatment ( P<0.05 ) . These renal effects were accompanied by a significantly enhanced vasodilator response to acetylcholine in the forearm after simvastatin treatment . Total serum cholesterol levels were significantly reduced after treatment with simvastatin , from 4.24+/-0.32 to 3.17+/-0.22 mmol/l ( P<0.001 ) . CONCLUSION We concluded that simvastatin treatment can ameliorate renal function in ADPKD patients , by increasing renal plasma flow , possibly via improvement of endothelial function . Long-term clinical trials with HMG-CoA reductase inhibitors are needed to confirm these results and to establish a chronic inhibiting effect of HMG-CoA reductase inhibitors on the progression towards end-stage renal disease in ADPKD patients BACKGROUND Chronic kidney diseases , particularly if presenting with significant proteinuria , are commonly associated with substantial alteration of serum lipid levels . Experimental evidence suggests that lipid abnormalities may contribute to the progression of kidney disease . However , studies in humans on the subject are scarce . METHODS In a prospect i ve , controlled open-label study , the authors have evaluated the effects of one-year treatment with atorvastatin , a 3-hydroxy-3-methyglutaryl coenzyme A ( HMG-CoA ) reductase inhibitor , versus no treatment on proteinuria and progression of kidney disease in 56 patients with chronic kidney disease . Before r and omization , all patients had already been treated for one year with angiotensin-converting enzyme ( ACE ) inhibitors or angiotensin AT1 receptor antagonists ( ARBs ) and other
Output:
| Statin therapy seems to reduce proteinuria modestly and results in a small reduction in the rate of kidney function loss , especially in population s with cardiovascular disease |
MS211477 | ***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 Malocclusion is a common disease of oral and maxillofacial region . The study was aim ed to investigate levels changes of periodontal pathogens in malocclusion patients before , during and after orthodontic treatments , and to confirm the difference between adults and children . Method One hundred and eight malocclusion patients ( 46 adults and 62 children at the school-age ) were r and omly selected and received orthodontic treatment with fixed orthodontic appliances . Subgingival plaques were Porphyromonas gingivalis ( P.gingivalis ) , Fusobacterium nucleatum ( F. nucleatum ) , Prevotella intermedia ( P. intermedia ) and Tannerella forsythensis ( T. forsythensis ) collected from the observed regions before and after treatment . Clinical indexes , including plaque index ( PLI ) , gingival index ( GI ) , sulcus bleeding index ( SBI ) , probing depth ( PD ) and attachment loss ( AL ) of observed teeth were examined . Results The detection rates of P.gingivalis , F. nucleatum , P. intermedia and T. forsythensis increased from baseline to the third month without significant difference , and then returned to pretreatment levels 12 month after applying fixed orthodontic appliances . Adults ’ percentage contents of P.gingivalis , F. nucleatum , P. intermedia and T. forsythensis were significantly higher than those of children at baseline and the first month , but not obvious at the third month . PLI and SBI were increased from baseline to the first and to the third month both in adults and children groups . Besides , PD were increased from baseline to first month , followed by a downward trend in the third month ; however , all patients were failed to detect with AL . Conclusions Periodontal and microbiological statuses of malocclusion patients may be influenced by fixed orthodontic appliances in both adults and children , more significant in children than in adults . Some microbiological indexes have synchronous trend with the clinical indexes . Long-term efficacy of fixed orthodontic appliances for malocclusion should be confirmed by future research es OBJECTIVE To evaluate the effect of different bracket types on the levels of Streptococcus mutans ( SM ) and Lactobacillus ( LB ) in saliva , in plaque , and on the periodontal condition . MATERIAL S AND METHODS Forty patients aged 14 to 16 years , who had Angle Class I malocclusion with minimal crowding , were nonsmokers , were without systematic disease , and did not use antibiotics or oral mouth rinses during the 3-month period before the study were r and omly selected . The patients were subdivided into two groups with r and om allocation of bracket type : conventional brackets ( CB ; Avex Mx , OPAL orth . ) with steel wire ligature or self-ligating brackets ( SLB ; F1000 , Leone S.p . A. ) . Microbial and periodontal records were obtained before bonding ( T1 ) and 1 month after bonding ( T2 ) . Microbial sample s were collected from the stimulated saliva and the plaque from the labial surfaces of the upper and lower lateral incisors . To estimate the number of colony-forming units of SM and LB , Dentocult SM and LB kits were used . The plaque index ( PI ) , gingival index ( GI ) , and pocket depth ( PD ) values were recorded to evaluate the periodontal condition . Paired t-test and Mann-Whitney U-test were used to compare the groups statistically . RESULTS No significant differences occurred in SM or LB colonization between the groups . In the SLB group , PI , GI , and PD values increased significantly ( P < .05 ) . A greater increase was found in PD value in the SLB group ( 0.98 mm ) compared with the CB group ( 0.04 mm ; P < .05 ) . CONCLUSIONS The F1000 SLB do not have an advantage over Avex Mx CB with respect to periodontal status and colonization of SM and LB The aim of this longitudinal study was to monitor patients ' microbiological and clinical parameters from bracket placement up to 3 months post-treatment . Twenty-four patients ( 10 males and 14 females , aged 14.6 ± 1.0 years ) were included in this investigation . Microbiology ( sub- and supragingival ) , periodontal probing depth ( PPD ) , bleeding on probing ( BOP ) , and gingival crevicular fluid ( GCF ) flow were assessed at baseline ( T1 ) , at bracket removal ( T2 ) , and 3 months post-treatment ( T3 ) . A statistical comparison was made over time and between the b and ed , bonded , and control sites . Repeated measurements on patients were taken into account by modelling the patients as a r and om factor . Except for PPD and BOP , values were log-transformed before analysis . Corrections for simultaneous hypothesis testing were performed via simulation . The results demonstrated that sub- and supragingival colony-forming units ratio ( CFU ratio aerobe/anaerobe ) decreased significantly ( relatively more anaerobes ) at T2 compared with T1 . Between T2 and T3 no significant increase in CFU ratio was seen , result ing in a significantly lower CFU ratio at T3 compared with T1 for subgingival plaque . The difference concerning supragingival plaque between T3 and T1 was not significant . Clinical parameters PPD , POB , and GCF flow showed a significant increase between T1 and T2 . Between T2 and T3 these variables decreased significantly but remained significantly higher than at T1 [ except for BOP values at the bonded sites ( P = 0.0646 ) ] . Placement of fixed orthodontic appliances has an influence both on microbial and clinical periodontal parameters , which were only partly normalized , 3 months following the removal of the appliances The goal of this study was to evaluate the clinical and microbiological factors associated with orthodontic appliances during an episode of gingival inflammation and the impact of appliance removal on periodontal health . This prospect i ve study included 10 patients , aged 12 to 20 years , with clinical signs of gingival inflammation at the final phase of orthodontic treatment ( appliance removal ) . Plaque index , gingival index , and probing depth were evaluated , and microbiological sample s were collected from teeth 16 , 11 , and 26 at 2 times : during the gingival inflammation ( baseline ) and 30 days after the removal of the appliance and professional prophylaxis . Polymerase chain reaction analysis was used to detect Porphyromonas gingivalis , Bacteroides forsythus , Actinobacillus actinomycetemcomitans , Prevotella intermedia , and Prevotella nigrescens . A statistically significant improvement of the plaque and gingival indexes was seen , as well as a reduction in probing depth ( P < .05 ) . Periodontal pathogens were associated with gingival inflammation during orthodontic treatment . The improvement in periodontal health at 30 days was concomitant with a reduction of sites positive for A. actinomycetemcomitans and B. forsythus ( P < .05 ) . Periodontal pathogens associated with gingival inflammation during orthodontic treatment can be significantly reduced by orthodontic appliance removal and professional prophylaxis OBJECTIVES Fixed orthodontic appliances cause plaque accumulation around b and s and brackets . Since the microbiological composition of dental plaque is closely connected to periodontal tissue health , the aim of this study was to determine the effects of fixed orthodontic appliances on subgingival microflora and periodontal status . METHODS This prospect i ve study was carried out on 32 adolescents scheduled for fixed orthodontic treatment . Subgingival dental plaque sample s and periodontal records ( pocket probing depth and clinical attachment level ) were obtained in four recording times : before bonding of fixed appliances ( T0 ) , 1 ( T1 ) , 3 ( T2 ) and 6 ( T3 ) months after the beginning of orthodontic therapy , in order to detect the changes in periodontopathic anaerobe microbial flora and its effects on periodontal status . RESULTS The values of pocket probing depth , total number of microorganisms and number of patients with positive findings of Prevotella intermedia and other periodontopathic anaerobes increased from T0 to the maximum obtained in T2 recording time . Both clinical and microbiological values decreased 6 months after the beginning of orthodontic therapy . CONCLUSIONS The therapy with fixed appliances may transitionally increase the growth of periodontopathogenic bacteria and consequently result in gingival inflammatory response but without destructive effect on deep periodontal tissues OBJECTIVES The aim of this prospect i ve study was to monitor patients ' microbiological and clinical periodontal parameters prior and up to 2 years after orthodontic treatment . MATERIAL AND METHODS Twenty-four adolescents were treated with brackets . Fourteen of them received b and s on upper first molars for extra-oral force application before bonding brackets to the remaining teeth . Microbiology , periodontal probing depth , bleeding on probing ( BOP ) , and gingival crevicular fluid ( GCF ) flow were assessed at baseline ( T1 ) , bracket removal ( T2 ) , and 2 years post-treatment ( T3 ) . A statistical comparison was made over time and between b and s and brackets . RESULTS A significant increase from T1 to T2 and a decrease from T2 to T3 in pathogenicity of plaque were noted . No significant difference was observed concerning supragingival colony-forming units ( CFU ) ratio ( aerobe/anaerobe ) between T3 and T1 . However , the subgingival CFU ratio ( aerobe/anaerobe ) at T3 did significantly differ from the ratio at T1 . Periodontal probing depth , BOP and GCF flow showed a significant increase between T1 and T2 and a reduction between T2 and T3 , result ing in the absence of significant differences between T3 and T1 , except for BOP at b and ed sites . CONCLUSION Placement of fixed appliances has an impact on periodontal parameters . The results showed that not all parameters were normalized at T3 , indicating that the changes are only partially reversible To determine a possible influence of two different hormonal contraceptives on bacterial microflora of gingival sulcus , subgingival plaque sample s of 29 healthy women aged between 20 and 32 years were investigated bacteriologically before subjects took a contraceptive and 10 and 20 days after subjects started the medication . In 14 women , and oral contraceptive containing 0.02 mg ethinyl estradiol and 0.15 mg desogestrel ( preparation A ) was used , and 15 women took a contraceptive containing 0.03 mg ethinyl estradiol and 2.00 mg dienogest ( preparation B ) daily over 21 days . There were no changes in clinical parameters of the teeth investigated during 3 weeks of the study . The periodontopathogenic bacteria Porphyromonas gingivalis and Actinobacillus actinomycetemcomitans were never detected throughout the study . On the other h and , the periodontopathogenic species Prevotella intermedia was found in plaque sample s of 22 women . The content of this microorganism showed only a little change between the pretreatment period and plaque sampling after 10 days of contraceptive treatment , but a striking increase occurred after 20 days of contraceptive treatment , especially in the preparation A group . In this respect , there was a significant difference between preparations A and BACKGROUND The outcome of microbiological diagnostics may depend on the sampling technique . It was the aim of the present study to compare two widely used sampling techniques for subgingival bacteria using quantitative real-time polymerase chain reaction . METHODS Twenty patients with chronic periodontitis were r and omized into two groups . In group A , sample s were taken first with a paper point and then with a curet at the same site ( single-rooted teeth with probing depth > 5 mm ) before scaling and root planing and after 10 weeks . The sampling sequence was reversed in group B. The analysis enabled the quantification of Actinobacillus actinomycetemcomitans , Fusobacterium nucleatum , Porphyromonas gingivalis , Prevotella intermedia , Treponema denticola , and Tannerella forsythensis and total bacterial counts ( TBCs ) . Statistical analysis included t test , kappa , and Spearman correlation . RESULTS Higher TBC was harvested with curets than by paper points ( P = 0.008 ) . The plaque composition with regard to total target pathogens was similar for both sampling techniques . A strong positive correlation was found between curet and paper point sample s for TBC and single target bacteria . CONCLUSIONS Overall , there was a relatively good agreement for the results of paper point and curet sampling . Thus , both techniques seem to be suitable for microbiological diagnostics Abstract Objective . The aim of this prospect i ve longitudinal study was to assess and compare the microbiological and clinical parameters of patients wearing a fixed orthodontic appliance , as opposed to 10 days after the bracket had been removed following treatment . Material s and methods . In total , 122 patients participated in this study ; 61 of the subjects were assessed at baseline ( wearing a fixed orthodontic appliance : T1 ) and 10 days after bracket removal ( T2 ) . The other 61 individuals had never worn an orthodontic appliance before and these subjects served as controls ( CT ) . Subgingival plaque sample s were assessed for bleeding on probing ( GBI ) and plaque index ( VPI ) . PCR of 16s rDNA , followed by reverse species-specific hybridization for Aggregatibacter actinomycetemcomitans , Porphyromonas gingivalis , Prevotella intermedia , Tannerella forsythia and Treponema denticola were performed . A descriptive analysis was conducted ; chi-squared , Student ’s matched and unmatched t-tests , the point biserial correlation coefficient and the McNemar test were used to test for differences between groups ( p <
Output:
| Conclusion The levels of subgingival pathogens presented temporary increases after orthodontic appliance placement , and appeared to return to pretreatment levels several months later .
This indicates that orthodontic treatment might not permanently induce periodontal disease by affecting the level of subgingival periodontal pathogen levels . |
MS211478 | ***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 identify the pyrazinamide MIC above which st and ard combination therapy fails . Methods MICs of pyrazinamide were determined for Mycobacterium tuberculosis isolates , cultured from 58 patients in a previous r and omized clinical trial in Cape Town , South Africa . The MICs were determined using BACTEC MGIT 960 for isolates that were collected before st and ard treatment with isoniazid , rifampicin , pyrazinamide and ethambutol commenced . Weekly sputum collection s were subsequently made for 8 weeks in order to culture M. tuberculosis in Middlebrook broth medium . Classification and regression tree ( CART ) analysis was utilized to identify the pyrazinamide MIC predictive of sputum culture results at the end of pyrazinamide therapy . The machine learning-derived susceptibility breakpoints were then confirmed using st and ard association statistics that took into account confounders of 2 month sputum conversion . Results The pyrazinamide MIC range was 12.5 to > 100 mg/L for the isolates prior to therapy . The epidemiological 95 % cut-off value was > 100 mg/L. The 2 month sputum conversion rate in liquid cultures was 26 % by stringent criteria and 48 % by less stringent criteria . CART analysis identified an MIC breakpoint of 50 mg/L , above which patients had poor sputum conversion rates . The relative risk of poor sputum conversion was 1.5 ( 95 % CI : 1.2–1.8 ) for an MIC > 50 mg/L compared with an MIC ≤50 mg/L. Conclusions We propose a pyrazinamide susceptibility breakpoint of 50 mg/L for clinical decision making and for development of rapid susceptibility assays . This breakpoint is identical to that identified using computer-aided simulations of hollow fibre system output BACKGROUND It is believed that nonadherence is the proximate cause of multidrug-resistant tuberculosis ( MDR-tuberculosis ) emergence . The level of nonadherence associated with emergence of MDR-tuberculosis is unknown . Performance of a r and omized controlled trial in which some patients are r and omized to nonadherence would be unethical ; therefore , other study design s should be utilized . METHODS We performed hollow fiber studies for both bactericidal and sterilizing effect , with inoculum spiked with 0.5 % rifampin- and isoniazid-resistant isogenic strains in some experiments . St and ard therapy was administered daily for 28 - 56 days , with extents of nonadherence varying between 0 % and 100 % . Sizes of drug-resistant population s were compared using analysis of variance . We also explored the effect of pharmacokinetic variability on MDR-tuberculosis emergence using computer-aided clinical trial simulations of 10 000 Cape Town , South Africa , tuberculosis patients . RESULTS Therapy failure was only encountered at extents of nonadherence ≥60 % . Surprisingly , isoniazid- and rifampin-resistant population s did not achieve ≥1 % proportion in any experiment and did not achieve a higher proportion with nonadherence . However , clinical trial simulations demonstrated that approximately 1 % of tuberculosis patients with perfect adherence would still develop MDR-tuberculosis due to pharmacokinetic variability alone . CONCLUSIONS These data , based on a pre clinical model , demonstrate that nonadherence alone is not a sufficient condition for MDR-tuberculosis emergence Possible masking of tuberculosis ( TB ) in treatment of community-acquired respiratory infection by newer fluoroquinolones has not been examined in r and omised controlled trials . We undertook a r and omised , open-label controlled trial involving adults with community-acquired pneumonia or infective exacerbation of bronchiectasis encountered in government chest clinics in Hong Kong . 427 participants were assigned by r and om permutated blocks of 20 to receive either amoxicillin clavulanate ( n = 212 ) or moxifloxacin ( n = 215 ) . Participants were followed for 1 yr for active pulmonary TB . Excluding three participants with positive baseline culture , 13 developed active pulmonary TB : 10 ( 4.8 % ) out of 210 were given amoxicillin clavulanate , and three ( 1.4 % ) out of 214 were given moxifloxacin . The difference was significant by both proportion and time-to-event analysis . Post hoc analysis showed a significant decrease in the proportion with active pulmonary TB from 4.8 % to 2.4 % and 0 % among participants given amoxicillin clavulanate ( n = 210 ) , moxifloxacin for predominantly 5 days ( n = 127 ) and 10 days ( n = 87 ) , respectively . The log rank test for trend also showed a significant difference between the three subgroups . Regression models reaffirmed the linear effect ; the adjusted odds ratio ( 95 % confidence interval ) of active pulmonary TB after moxifloxacin exposure up to predominantly 10 days was 0.3 ( 0.1–0.9 ) . Newer fluoroquinolones appear to mask active pulmonary TB The identification of multidrug resistant ( MDR ) , extensively and totally drug resistant Mycobacterium tuberculosis ( Mtb ) , in vulnerable sites such as Mumbai , is a grave threat to the control of tuberculosis . The current study aim ed at explaining the rapid expression of MDR in Directly Observed Treatment Short Course ( DOTS ) compliant patients , represents the first study comparing global transcriptional profiles of 3 pairs of clinical Mtb isolates , collected longitudinally at initiation and completion of DOTS . While the isolates were drug susceptible ( DS ) at onset and MDR at completion of DOTS , they exhibited identical DNA fingerprints at both points of collection . The whole genome transcriptional analysis was performed using total RNA from H37Rv and 3 locally predominant spoligotypes viz . MANU1 , CAS and Beijing , hybridized on MTBv3 ( BuG@S ) microarray , and yielded 36 , 98 and 45 differentially expressed genes respectively . Genes encoding transcription factors ( sig , rpoB ) , cell wall bio synthesis ( emb genes ) , protein synthesis ( rpl ) and additional central metabolic pathways ( ppdK , pknH , pfkB ) were found to be down regulated in the MDR isolates as compared to the DS isolate of the same genotype . Up regulation of drug efflux pumps , ABC transporters , trans-membrane proteins and stress response transcriptional factors ( whiB ) in the MDR isolates was observed . The data indicated that Mtb , without specific mutations in drug target genes may persist in the host due to additional mechanisms like drug efflux pumps and lowered rate of metabolism . Furthermore this population of Mtb , which also showed reduced DNA repair activity , would result in selection and stabilization of spontaneous mutations in drug target genes , causing selection of a MDR strain in the presence of drug pressures . Efflux pump such as drrA may play a significant role in increasing fitness of low level drug resistant cells and assist in survival of Mtb till acquisition of drug resistant mutations with least fitness cost BACKGROUND Based on a hollow-fiber system model of tuberculosis , we hypothesize that microbiologic failure and acquired drug resistance are primarily driven by low drug concentrations that result from pharmacokinetic variability . METHODS Clinical and pharmacokinetic data were prospect ively collected from 142 tuberculosis patients in Western Cape , South Africa . Compartmental pharmacokinetic parameters of isoniazid , rifampin , and pyrazinamide were identified for each patient . Patients were then followed for up to 2 years . Classification and regression tree analysis was used to identify and rank clinical predictors of poor long-term outcome such as microbiologic failure or death , or relapse . RESULTS Drug concentrations and pharmacokinetics varied widely between patients . Poor long-term outcomes were encountered in 35 ( 25 % ) patients . The 3 top predictors of poor long-term outcome , by rank of importance , were a pyrazinamide 24-hour area under the concentration-time curve ( AUC ) ≤ 363 mg·h/L , rifampin AUC ≤ 13 mg·h/L , and isoniazid AUC ≤ 52 mg·h/L. Poor outcomes were encountered in 32/78 patients with the AUC of at least 1 drug below the identified threshold vs 3/64 without ( odds ratio = 14.14 ; 95 % confidence interval , 4.08 - 49.08 ) . Low rifampin and isoniazid peak and AUC concentrations preceded all cases of acquired drug resistance . CONCLUSIONS Low drug AUCs are predictive of clinical outcomes in tuberculosis patients ABSTRACT Tuberculous meningitis ( TBM ) is the most lethal form of tuberculosis , and new treatments that improve outcomes are required . We r and omly assigned adults with TBM to treatment with st and ard antituberculosis treatment alone or in combination with ciprofloxacin ( 750 mg/12 h ) , levofloxacin ( 500 mg/12 h ) , or gatifloxacin ( 400 mg/24 h ) for the first 60 days of therapy . Fluoroquinolone concentrations were measured with plasma and cerebrospinal fluid ( CSF ) specimens taken at predetermined , r and omly assigned times throughout treatment . We aim ed to describe the pharmacokinetics of each fluoroquinolone during TBM treatment and evaluate the relationship between drug exposure and clinical response over 270 days of therapy ( Controlled Trials number IS RCT N07062956 ) . Sixty-one patients with TBM were r and omly assigned to treatment with no fluoroquinolone ( n = 15 ) , ciprofloxacin ( n = 16 ) , levofloxacin ( n = 15 ) , or gatifloxacin ( n = 15 ) . Cerebrospinal fluid penetration , measured by the ratio of the plasma area under the concentration-time curve from 0 to 24 h ( AUC0–24 ) to the cerebrospinal fluid AUC0–24 , was greater for levofloxacin ( median , 0.74 ; range , 0.58 to 1.03 ) than for gatifloxacin ( median , 0.48 ; range , 0.47 to 0.50 ) or ciprofloxacin ( median , 0.26 ; range , 0.11 to 0.77 ) . Univariable and multivariable analyses of fluoroquinolone exposure against a range of different treatment responses revealed worse outcomes among patients with lower and higher plasma and CSF exposures than for patients with intermediate exposures ( a U-shaped exposure-response ) . TBM patients most likely to benefit from fluoroquinolone therapy were identified , along with exposure-response relationships associated with improved outcomes . Fluoroquinolones add antituberculosis activity to the st and ard treatment regimen , but to improve outcomes of TBM , they must be started early , before the onset of coma Background : Moxifloxacin ( MFX ) is a potent drug for multidrug resistant tuberculosis(TB ) treatment and is also useful if first-line agents are not tolerated . Therapeutic drug monitoring may help to prevent treatment failure . Obtaining a full concentration-time curve of MFX for therapeutic drug monitoring is not feasible in most setting s. Developing a limited-sampling strategy based on population pharmacokinetics ( PK ) may help to overcome this problem . Methods : Steady-state plasma concentrations after the administration of 400 mg of MFX once daily were determined in 21 patients with TB , using a vali date d liquid chromatography-t and em mass spectrometry method . A one-compartment population model was generated and crossvali date d. Monte Carlo data simulation ( n = 1000 ) was used to calculate limited-sampling strategies . The correlation between predicted MFX AUC0 - 24h ( area under the concentration-time curve 0 to 24 hours ) and observed AUC0 - 24h was investigated by Bl and -Altman analysis . Finally , the predictive performance of the final model was tested prospect ively using MFX profiles from patients with TB receiving 400 , 600 , or 800 mg once daily . Results : Median minimum inhibitory concentration of Mycobacterium tuberculosis isolates was 0.25 mg/L ( interquartile range : 0.25 - 0.5 mg/L ) . The geometric mean AUC0 - 24h was 24.5 mg·h/L ( range : 8.5 - 72.2 mg·h/L ) , which result ed in a geometric mean AUC0 - 24h/minimum inhibitory concentration ratio of 72 ( range : 21 - 321 ) . PK analysis , based on PK profiles of 400 mg of MFX once daily , result ed in a crossvali date d population PK model with the following parameters : apparent clearance ( Cl ) 18.5 ± 8.6 L/h per 1.85 m2 , Vd 3.0 ± 0.7 L/kg corrected lean body mass , Ka 1.15 ± 1.16 h−1 , and F was fixed at 1 . After the Monte Carlo simulation , the best predicting strategy for MFX AUC0 - 24h for practical use was based on MFX concentrations 4 and 14
Output:
| The HFS-TB model is highly accurate at forecasting optimal drug exposures , doses , and dosing schedules for use in the clinic |
MS211479 | ***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 Periodontitis and peri-implantitis are linked to the presence of several key pathogens . The treatment of these infectious processes therefore involves the reduction/eradication of bacteria associated with periodontitis . METHODS This prospect i ve , split-mouth , single-blind study followed the colonization of ' pristine ' sulci created in 42 partially edentulous patients during implant surgery ( e.g. abutment connection ) . The hypothesis was that the composition of the maturing subgingival plaque in these ' fresh ' peri-implant pockets would soon ( within 2 weeks ) be comparable to the subgingival microbiota of teeth with similar clinical parameters ( reference sites ) , including the presence of bacteria associated with periodontitis . Per patient , four subgingival plaque sample s were taken from shallow and medium pockets around implants ( test sites ) , and teeth within the same quadrant ( undisturbed microbiota as control sites ) , 1 , 2 , 4 , 13 , 26 and 78 weeks after abutment connection , respectively . The sample s were analysed by either checkerboard DNA-DNA hybridization , or cultural techniques , or real-time polymerase chain reaction ( PCR ) for intra-subject comparisons ( teeth vs. implant , for comparable probing depths ) . RESULTS Checkerboard DNA-DNA hybridization and real-time PCR revealed a complex microbiota ( including several pathogenic species ) in the peri-implant pockets within 2 weeks after abutment connection . After 7 days , the detection frequency for most species ( including the bacteria associated with periodontitis ) was already nearly identical in sample s from the fresh peri-implant pockets ( 5 % and 20 % of the microbiota belonging to red and orange complex , respectively ) when compared with sample s from the reference teeth . Afterwards ( e.g. between weeks 2 and 13 ) , the number of bacteria in peri-implant pockets only slightly increased ( + /-0.1 log value ) , with minor changes in the relative proportions of bacteria associated with periodontitis ( 8 % and 33 % of the microbiota belonging to red and orange complex , respectively ) . Although small differences were seen between teeth and implants at week 2 with cultural techniques , a striking similarity in subgingival microbiota was found with this technique from month 3 on , with nearly identical detection frequencies for bacteria associated with periodontitis for both abutment types . CONCLUSIONS This study indicates that the initial colonization of peri-implant pockets with bacteria associated with periodontitis occurs within 2 weeks BACKGROUND Long-term follow-up studies ( i.e. , over 5 years ) , focusing on prosthetic outcomes and maintenance of implant-supported reconstructions in the edentulous maxilla , are scarce in the literature . PURPOSE The purpose of this study was to evaluate and report 10-year data on outcomes and maintenance of screw-retained implant-supported full-arch casted titanium-resin prostheses in the edentulous maxilla . MATERIAL S AND METHODS In the r and omized control trial cohort of 24 patients , the outcome and maintenance of 23 bridges were registered . RESULTS One patient dropped out of the study prior to the 10-year control . Of the 23 remaining patients , 21 still had their original frameworks ; one framework fractured after 8 years and one was remade after 7 years to create better support for the acrylic . The remaining 23 prostheses showed criteria of success , survival , and failure in 9 , 82 , and 9 % , respectively . Tightening of two assembly screws was necessary in one patient . No detrimental effects were seen because of long cantilever extensions or opposing dentition . A total of 4.7 resin-related complications per prosthesis were observed ; tooth fracture was the most common prosthetic complication . There was an indication of greater prevention in the number of resin-related complications with the use of lingual gold onlay compared with a resilient mouth guard , 0.71 and 1.67 , respectively per bridge . The bridges were removed and reinserted 0.83 times per patient . No abutment or abutment screw fractures were registered . CONCLUSION Fracture or wear of the reconstruction material s were considered predictable risks when using resin-based suprastructure material s. Status of opposing dentition and length of cantilevers did not confer additional risk . The use of a lingual gold onlay indicated prevention of resin-related complications . Future research should focus on the suprastructure material s to predict better overall treatment results of implant-supported full-arch bridges in the edentulous maxilla OBJECTIVE To monitor clinical , microbiological and host-derived alterations occurring around teeth and titanium implants during the development of experimental gingivitis/mucositis and their respective healing sequence in humans . MATERIAL AND METHODS Fifteen subjects with healthy or treated periodontal conditions and restored with dental implants underwent an experimental 3-week period of undisturbed plaque accumulation in the m and ible . Subsequently , a 3-week period with optimal plaque control was instituted . At Days 0 , 7 , 14 , 21 , 28 , 35 and 42 , the presence/absence of plaque deposits around teeth and implants was assessed , ( plaque index [ PlI ] ) and the gingival/mucosal conditions were evaluated ( gingival index[GI ] ) . Subgingival/submucosal plaque sample s and gingival/mucosal crevicular fluid ( CF ) sample s were collected from two pre-determined sites around each experimental unit . CF sample s were analyzed for matrix-metalloproteinase-8 ( MMP-8 ) and interleukin-1beta ( IL-1β ) . Microbial sample s were analyzed using DNA-DNA hybridization for 40 species . RESULTS During 3 weeks of plaque accumulation , the median PlI and GI increased significantly at implants and teeth . Implant sites yielded a greater increase in the median GI compared with tooth sites . Over the 6-week experimental period , the CF levels of MMP-8 were statistically significantly higher at implants compared with teeth ( P<0.05 ) . The CF IL-1β levels did not differ statistically significantly between teeth and implants ( P>0.05 ) . No differences in the total DNA counts between implant and tooth sites were found at any time points . No differences in the detection frequency were found for putative periodontal pathogens between implant and tooth sites . CONCLUSION Peri-implant soft tissues developed a stronger inflammatory response to experimental plaque accumulation when compared with that of their gingival counterparts . Experimental gingivitis and peri-implant mucositis were reversible at the biomarker level . Clinical ly , however , 3 weeks of resumed plaque control did not yield pre-experimental levels of gingival and peri-implant mucosal health indicating that longer healing periods are needed BACKGROUND There have been very few long-term controlled studies ( i.e. , over 5 years duration ) focusing on marginal conditions for implants with a s and blasted , large grit , and acid-etched ( SLA ) surface . PURPOSE To evaluate and report 10-year data on outcomes of implants with an SLA surface placed in the edentulous maxilla . MATERIAL S AND METHODS In a r and omized controlled trial ( RCT ) cohort of 24 patients , the outcomes of implants with an SLA surface were registered . The RCT cohort has previously been reported after 1 year , 3 years , and 5 years of loading . RESULTS One patient dropped out of the study prior to the 10-year control . Of the 23 remaining patients , the implant survival rate was 95.1 % . If implants of unknown status were also considered lost , that is , one drop-out patient with three implants for whom no information could be obtained , the implant survival rate was 93 % . The mean marginal bone loss from baseline ( 139 implants ) to 10 years ( 102 implants ) was 1.07 mm ( st and ard deviation 0.98 ) . One implant out of 102 available for radiographic examination according to the original protocol showed a bone loss exceeding 4 mm . Of the 84 implants available for clinical examination , none showed a Plaque Index or sulcus bleeding index of 3 . The mean implant stability quotient was significantly higher for mesial-distal versus buccal-palatal measurements . CONCLUSION The implant survival was 95.1 % . The mean value of bone loss after 10 years was 1.07 mm . Peri-implantitis were noted at the 5-year follow-up for one patient with a previous history of periodontitis ; this patient did not attend the 10-year follow-up . This study shows that s and blasted and acid-etched implants offers predictable long-term results as support for full-arch maxillary prostheses AIM To determine the incidence of peri-implantitis in individuals with mucositis in a 5-year follow-up study . MATERIAL AND METHODS A sample of 212 partially edentulous individuals , rehabilitated with dental implants , underwent periodontal and peri-implant clinical examinations in 2005 ( baseline ) . Five years later , 80 individuals who had been diagnosed with mucositis in the baseline examination were re-examined . These individuals were divided into two groups : one group with preventive maintenance during the study period ( GTP ; n = 39 ) , and another group without preventive maintenance ( GNTP ; n = 41 ) . The following parameters were clinical ly evaluated : plaque index , bleeding on periodontal and peri-implant probing , periodontal and peri-implant probing depth , suppuration and peri-implant bone loss . The influence of biological and behavioural risk variables associated with the occurrence of peri-implantitis was analysed using univariate and multivariate logistic regression analyses . RESULTS The incidence of peri-implantitis in the global sample was 31.2 % ( GNTP = 43.9 % and GTP = 18.0 % ) . CONCLUSION The absence of preventive maintenance in individuals with pre-existing peri-implant mucositis was associated with a high incidence of peri-implantitis . Clinical parameters , such as bleeding on peri-implant probing , periodontal probing depth and the presence of periodontitis were associated with a higher risk of developing peri-implantitis Eighty-two patients were treated in a split mouth design with coronal scaling ( CS ) , root planing ( RP ) , modified Widman surgery ( MW ) , and flap with osseous surgery ( FO ) which were r and omly assigned to the various quadrants in the dentition . Following phase I and phase II therapy , the patients received supportive periodontal treatment ( SPT ) at 3-month intervals for up to 7 years . Clinical attachment level ( CAL ) was determined initially , post-phase I , post-phase II and prior to each SPT appointment . If a site lost > or = 3 mm of CAL from its baseline , it was classified as a breakdown site . Baselines were the initial exam for sites treated by CS and 10 weeks post-phase II for sites treated by RP , MW , and FO . Data were grouped by probing depth ( PD ) severity at the initial exam and at post-phase II . The breakdown for CS sites was assessed separately from RP , MW , and FO sites because of different baselines and retreatment protocol s. Sites treated by CS had a higher incidence of breakdown than the other therapies through year 1 of SPT . The breakdown incidences/year for RP and MW sites were similar and greater than for FO sites in 1 to 4 mm and 5 to 6 mm PD categories . Breakdown incidence of RP sites was greater than MW sites which was greater than FO sites initially > or = 7 mm . Differences in incidence of breakdown between therapies after recategorizing data by post-phase II PD were the same as above , except no difference was present between RP and MW sites > or = 7 mm . Breakdown incidences were greater in increasing PD severities regardless of when they were categorized . There was no further loss of CAL one year after retreatment in 88 % of sites . Patients with higher breakdown incidences tended to be smokers at the initial exam OBJECTIVES To evaluate clinical ly and radiographically immediate implants 5 years after insertion and to compare them with delayed-placed implants in the same subjects . MATERIAL AND METHODS Twenty-two consecutive patients that needed at least two implants for replacing hopeless teeth , one immediately upon extraction and the other in a delayed fashion ( at least 4 months post- extraction ) were selected in this prospect i ve cohort study . Post- extraction immediate implants ( II ) and delayed implants ( DI ) groups were defined . One and 5 years after implant loading , clinical and radiographical outcome variables were recorded and analysed both at site and at implant level . Intra-group and inter-group comparisons were performed . RESULTS The intergroup comparison did not show significant differences for plaque index , bleeding on probing and suppuration . These parameters worsen in both groups along the study . This trend was stronger for the plaque index in the group II , which increased from 15.6 % at 1 year to 25.9 % at 5 years ( P < 0.04 ) . One year after loading , the sites with probing depth ≥5 mm were higher for the group II compared to DI ( 2.5 % vs. 0 % ; P = 0.049 ) . At the end of the study , no significant statistical differences were found . Radiographically , bone crestal changes did not yield significant differences . During the follow-up period , 25 % of the implants ( 26.4 % in group II and 23.5 % in DI ) showed biological complications : mucositis ( 20 % ) and /or periimplantitis ( 5.8 % ) . No differences between groups were found . CONCLUSIONS Within the same patients , the implants placed with the immediate protocol demonstrated a higher tendency to crestal bone loss and to peri-implantitis , although these
Output:
| Overall , regular diagnosis and implementation of anti-infective therapeutic protocol s were effective in the management of biological complications and prevention of implant loss .
Residual probing depths at the end of active periodontal therapy and development of reinfection during supportive periodontal therapy ( SPT ) represented a significant risk for the onset of peri-implantitis and implant loss .
Comparative studies indicated that implant survival and success rates were lower in periodontally compromised vs noncompromised patients . |
MS211480 | ***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 date , there are no published reports comparing hemodynamically (Hd)-stable and Hd-unstable patients with ruptured abdominal aortic aneurysms ( r-AAAs ) undergoing endovascular aneurysm repair ( EVAR ) . This study evaluates outcomes of EVAR for r-AAA based on patient 's Hd status METHODS From 2002 to 2011 , 136 patients with r-AAAs underwent EVAR and were categorized into two groups based on systolic blood pressure ( SBP ) measurements before EVAR : 92 ( 68 % ) Hd-stable ( SBP ≥ 80 mm Hg ) and 44 ( 32 % ) Hd-unstable ( SBP < 80 mm Hg for > 10 minutes ) . All data were prospect ively entered in a data base and retrospectively analyzed . Outcomes included 30-day mortality , postoperative complications , the need for secondary re interventions , and midterm mortality . The effect of potential predictors on 30-day mortality was assessed by χ(2 ) and logistic regression . RESULTS Of the 136 r-AAA patients with EVAR , the Hd-stable and Hd-unstable groups had similar comorbidities ( coronary artery disease , 63 % vs 59 % ; hypertension , 72 % vs 75 % ; chronic obstructive pulmonary disease , 21 % vs 26 % ; and chronic renal insufficiency , 18 % vs 18 % ) , mean AAA maximum diameter ( 6.6 vs 6.4 cm ) , need for on-the-table conversion to open surgical repair ( 3 % vs 7 % ) , and incidences of nonfatal complications ( 43 % vs 38 % ) and secondary interventions ( 23 % vs 25 % ) . Preoperative computed tomography scan was available in significantly fewer Hd-unstable patients ( 64 % vs 100 % ; P < .05 ) . Compared with Hd-stable patients , the Hd-unstable patients had a significantly higher intraoperative need for aortic occlusion balloon ( 40 % vs 6 % ; P < .05 ) , mean estimated blood loss ( 744 vs 363 mL ; P < .05 ) , incidence of developing abdominal compartment syndrome ( ACS ; 29 % vs 4 % ; P < .01 ) , and death ( 33 % vs 18 % ; P < .05 ) . ACS was a significant predictor of death ; death in all r-EVAR with ACS was significantly higher compared with all r-EVAR without ACS ( 10 of 17 [ 59 % ] vs 22 of 119 [ 18 % ] ; P < .01 ) . CONCLUSIONS EVAR for r-AAA is feasible in Hd-stable and Hd-unstable patients , with a comparable incidence of conversion to open surgical repair , nonfatal complications , and secondary interventions . Hd-stable patients have reduced mortality at 30 days , whereas Hd-unstable patients require intraoperative aortic occlusion balloon more frequently , and have an increased risk for developing ACS and death INTRODUCTION EVAR has the potential to improve outcome after ruptured abdominal aortic aneurysm ( AAA ) . Published series have been based upon selected population s. METHODS An interim analysis of a single centre prospect i ve r and omised controlled trial comparing endovascular aneurysm repair ( EVAR ) with open aneurysm repair ( OAR ) in patients with ruptured AAA was performed . Patients who had a ruptured AAA and who were considered fit for open repair were r and omised to EVAR or OAR after consent had been obtained . Those in the EVAR group had pre-operative spiral computed tomographic angiography ( CTA ) . The primary endpoint was operative ( 30-day ) mortality and secondary endpoints were moderate or severe operative complications , hospital stay and time between diagnosis and operation . A power study calculation required 100 patients to be recruited . RESULTS Between September 2002 and December 2004 , 103 patients were admitted with suspected ruptured AAA . Only 32 patients were recruited to the study . Of these , four patients died before receiving surgical treatment . On an intention to treat basis the 30-day mortality rate was 53 % in the EVAR group and 53 % in the OAR group . Moderate or severe operative complications occurred in 77 % in the EVAR group and in 80 % in the OAR group . Median total hospital stay in the EVAR group was 10 days ( inter-quartile range 6 - 28 ) and 12 days ( 4 - 52 ) in the OAR group . Median time between diagnosis and operation was 75 minutes ( 64 - 126 ) in the EVAR group and 100 minutes ( 48 - 138 ) in the OAR group . CONCLUSIONS Despite the relative high operative mortality in the EVAR group , these preliminary results show that it is possible to recruit patients to a r and omised trial of OAR and EVAR in patients with ruptured AAA . CT scanning does not delay treatment OBJECTIVE Endovascular aneurysm repair ( EVAR ) decreases 30-day mortality for patients with ruptured abdominal aortic aneurysms ( r-AAAs ) compared with open surgical repair ( OSR ) . However , which patients benefit or whether there is any long-term survival advantage is uncertain . METHODS From 2002 to 2011 , 283 patients with r-AAA underwent EVAR ( n = 120 [ 42.4 % ] ) or OSR ( n = 163 [ 57.6 % ] ) at Albany Medical Center . All data were collected prospect ively . Patients were analyzed on an intention-to-treat basis , and outcomes were evaluated by a logistic regression multivariable model . Kaplan-Meier analysis was used to compare long-term survival . RESULTS The EVAR patients had a significantly lower 30-day mortality than did the OSR patients ( 29/120 [ 24.2 % ] vs 72/163 [ 44.2 % ] ; P < .005 ) and better cumulative 5-year survival ( 37 % vs 26 % ; P < .005 ) . Men benefited more from EVAR ( mortality : 20.9 % for EVAR vs 44.3 % for OSR ; P < .001 ) than did women ( mortality : 32.4 % vs 43.9 % ; P = .39 ) . Age ≥80 years was a significant predictor of death for EVAR ( odds ratio [ OR ] , 1.07 ; P = .003 ) but not for OSR ( OR , 1.04 ; P = .056 ) . Preexisting hypertension was a significant predictor of survival for both EVAR ( OR , 0.17 ; P < .001 ) and OSR ( OR , 0.48 ; P = .021 ) . Almost one fourth of EVAR patients ( 21/91 [ 23.1 % ] ) required secondary interventions . Survival advantage was maintained for EVAR patients to 5 years . CONCLUSIONS For r-AAA , EVAR reduces the 30-day mortality and improves long-term survival up to 5 years . However , whereas open survivors require few graft-related interventions , up to 23 % of EVAR patients will require reintervention for endoleaks or graft migration . Close follow-up of all EVAR survivors is m and atory OBJECTIVES Our institution treats about 30 patients per year with ruptured abdominal aortic aneurysms ( rAAA ) . Between 2002 and 2007 , our 30-day mortality averaged 58 % . In July 2007 , we implemented an algorithm to promote endovascular aneurysm repair ( EVAR ) when feasible . This report describes the outcome with this approach . METHODS Data on patients presenting with rAAA between July 1 , 2002 , and June 30 , 2007 , were review ed and used for comparison to prospect ively collected data . Data on patients presenting between July 1 , 2007 , and April 30 , 2009 , were collected on all patients after implementation of a structured protocol . The primary outcome measure was 30-day mortality . Data were analyzed using logistic regression . Kaplan-Meier survival curves and a log-rank test were performed to compare survival times for three groups ( pre- protocol , post- protocol with open surgery , and post- protocol with EVAR ) . RESULTS During the study period , 187 patients with rAAA presented to our institution . Before implementation of the algorithm , 131 patients with rAAA presented and 128 were treated . The 30-day mortality rate was 57.8 % . After implementation of the protocol , 56 patients with rAAA were managed . Twenty-seven patients ( 48 % ) underwent successful EVAR , and 24 patients ( 43 % ) underwent open repair . Five patients ( 9 % ) underwent comfort care only . In the post- protocol period , 5 patients in the EVAR group ( 18.5 % ) and 13 patients in the open group ( 54.2 % ) died during the follow-up period for an overall 30-day mortality rate of 35.3 % ( P = .008 vs 57.8 % pre- protocol ) . After implementation of a structured protocol for managing rAAA , there was a relative risk reduction in 30-day mortality of 35 % compared to the time before implementation of the protocol ( 95 % confidence interval [ CI ] , 14%-51 % ) corresponding to an absolute risk reduction of 22.5 % ( 95 % CI , 6.8%-38.2 % ) and an odds ratio of 0.40 ( 95 % CI , 0.20 - 0.78 ; P = .007 ) . After adjusting for key factors predicting mortality , the odds ratio is 0.25 ( 95 % CI , 0.10 - 0.57 ; P = .001 ) . CONCLUSION Use of an algorithm favoring endovascular repair result ed in a highly significant reduction in rAAA mortality in our urban hospital . Thirty-day mortality for open repair was no different between pre- and post- protocol eras . With modern techniques of resuscitation and surgical management , a majority of patients presenting with rAAA can survive OBJECTIVES The aim of this study was to compare all in-hospital mortality for ruptured abdominal aortic aneurysms ( rAAAs ) before and after the establishment of an emergency EVAR ( eEVAR ) service . DESIGN AND METHODS An eEVAR service was established in January 2006 , since when all patients presenting with rAAAs have been considered for endovascular repair . Data for all rAAAs presenting between January 2006 and December 2007 was prospect ively collected ( Group 1 ) . This patient group was compared to those presenting with rAAA between January 2003 and December 2005 when eEVAR was not offered at our institution ( Group 2 ) . These records had also been collected prospect ively and su bmi tted to the National Vascular Data base ( NVD ) . RESULTS A total of 50 rAAAs ( 17 eEVAR , 29 open repairs , 4 palliated ) presented after the introduction of eEVAR ( Group 1 ) and 71 in the historical Group 2 of which 54 underwent open repair and 17 were palliated . The total in-hospital mortality was significantly lower in Group 1 20 % ( eEVAR ( n=1 ) , 6 % : Open ( n=5 ) , 17 % : palliated ( n=4 ) , 100 % ) when compared to Group 2 54 % ( Open ( n=21 ) , 39 % : palliated ( n=17 ) , 100 % ) ( p=0.000001 ) . Furthermore similar significant differences were seen in 30-day operative mortalities between the two groups 13 % in Group 1 versus 39 % in Group 2 ( p=0.0003 ) . In addition the proportion of patients who were palliated has significantly decreased ( 8 % Group 1 versus 24 % Group 2 , p=0.01 ) . CONCLUSIONS The establishment of an eEVAR service has significantly reduced in-hospital mortality for patients presenting with ruptured abdominal aortic aneurysms AIM Several studies have shown the feasibility of endovascular repair of ruptured abdominal aortic aneurysms ( rEVAR ) . However , the role and value of rEVAR remains controversial due to selection bias and lack of long-term results . In the present study we describe our short- and long-term results of treating patients with rEVAR irrespective of hemodynamic condition and challenging anatomy . METHODS In April 2006 we started the single centre prospect i ve non-r and omised Ruptured Aneurysm Study ( RASA ) . During a four year enrolment period all consecutive patients presenting with infrarenal ruptured AAA ( rAAA , N.=117 ) were assessed for preferential rEVAR treatment . A rAAA was defined as extravasation of blood or hematoma outside the AAA due to transmural tear in the infrarenal abdominal aorta wall documented by preoperative computed tomography ( CT ) angiography examination or during open repair . Patients with challenging anatomy ( infrarenal neck length below 15 mm and neck angulation above 60 degrees ) were included as part of a damage control concept . Complication and mortality rates were studied at 30 days and yearly afterwards . RESULTS Thirty-five patients ( 33 % of all
Output:
| However , after the introduction of EVAR and OPEN protocol s , the overall mortality for RAAA was reduced compared with the only OPEN option , suggesting a beneficial effect of EVAR in selected cases |
MS211481 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: Abstract Objectives : To describe the impact of surgery for stress incontinence on the severity of symptoms , other mental and physical symptoms , and overall health . To describe the incidence of postoperative complications . Design : Prospect i ve cohort study ; question naires completed by patients before and 3 , 6 , and 12 months after surgery . Question naires completed by surgeons both before and after surgery . Setting : 18 hospitals in the North Thames region . Subjects : 442 women treated surgically for stress incontinence between January 1993 and June 1994 . 367 women returned the 3 month question naire ; 364 returned the 6 month question naire ; and 359 returned the 12 month question naire . 49 surgeons provided perioperative information on 285 of the 442 women and postoperative information on 278 . Main outcome measures : Stress incontinence symptom severity index , other urinary symptoms , bowel function , mental health , complications , global measures . Results : Most women ( 288 ; 87 % ) reported an improvement in the severity of their stress incontinence , though only 92 ( 28 % ) were cured ( continent ) . These improvements persisted for at least 12 months . The likelihood of improvement was similar regardless of whether urodynamic pressure studies had been conducted before surgery . Following surgery , women were less likely to suffer from urinary frequency , nocturia , postvoid fullness , dysuria , and urgency . While mental health improved for 194 ( 71 % ) , a quarter of women reported deterioration . Only 37 ( 10 % ) were satisfied with postoperative pain control . A third experienced one or more complications while in hospital , most commonly difficulty urinating . This problem affected 1 in 11 women after discharge . A year after surgery two thirds of women reported feeling better ( 251 ; 72 % ) , that the outcome met or exceeded their expectations ( 230 ; 66 % ) , and that they would recommend the operation to a friend in a similar situation ( 239 ; 68 % ) . Surgeons tended to be more optimistic about the effects of surgery ; they were satisfied with the outcome in 176 ( 85 % ) cases and would again treat 245 ( 94 % ) of the women as they had done previously . Conclusions : Although surgery reduces the severity of stress incontinence it is not as effective as current textbooks suggest . Women considering surgery should be provided with more accurate information on the likelihood of an improvement in symptoms and the occurrence of complications , including postoperative pain . Urgency and urge incontinence should not be considered contraindications to surgery . The need for urodynamic assessment before surgery should be reappraised . Key messages Although surgery improves stress incontinence in most women ( 87 % ) , only 28 % are continent one year later The need for preoperative urodynamic testing should be reappraised Urgency and urge incontinence should not be considered contraindications to surgery Women considering surgery should receive more accurate information on the probability of an improvement in symptoms and possible complications There is a need for a rigorous , pragmatic , r and omised trial of surgery for stress A total of 51 consecutive female patients with genuine stress incontinence who underwent a Burch or Stamey operation were clinical ly and urodynamically evaluated preoperatively at least 8 months postoperatively . Our study group consisted of 27 women who underwent the Burch colposuspension and 24 who had the Stamey endoscopic bladder neck suspension . The urodynamic parameters which were studied pre- and postoperatively were the maximum flow rate ( Qmax ) , the residual urine ( Vres ) , the first sensation ( FS ) , the bladder capacity ( BC ) , the maximum vesical pressure ( Pves max ) , the detrusor pressure at maximum flow ( Pdet/Qmax ) , the functional urethral length ( Lfun ) and the maximum closure pressure ( Pclos max ) . The successful results of the operations were 89 % for Burch and 83 % for the Stamey procedure . As for differing objective urodynamic findings , the Qmax , Pclos max , Vres and Lfun for both groups were the only parameters which showed statistically significant difference after surgery . The statistical comparison of the postoperative urodynamic parameters of the two operative techniques showed that Lfun , Pves max and Pclos max had difference in favor of Burch colposuspension . There were not statistical differences in the other studied parameters . In conclusion , according to the differentiation in the values of Pclos max , Lfun and Pves max , the Burch technique seems to result in a higher increase of patient 's urethral resistance Thirty-nine patients ( from a total of 307 women ) with clinical and urodynamic diagnosis of stress urinary incontinence had cystometric findings consistent with detrusor instability . Detailed multichannel urethrocystometry of these 39 patients revealed that urethral relaxation preceded the bladder contraction by 2 - 5 s. These patients were r and omly allocated to either medical treatment ( n = 21 ) by Ditropan 5 mg t.i.d . for 6 weeks prior to the surgical procedure , or to surgical treatment ( n = 18 ) with no attempt to treat the bladder instability prior to surgery . All patients had repeat clinical and urodynamic evaluation at 3 - 12 months postoperatively . Six of the 39 patients ( 15 % ) still had urethral relaxation and bladder contractions on postoperative urethrocystometry . Four of these 6 patients still had stress urinary incontinence and urethral funneling . These 4 were considered surgical failures . Two of the 39 ( 5 % ) had postoperative detrusor instability in spite of good surgical results . This series suggests that in women with combined stress urinary incontinence and bladder instability , where bladder contraction is preceded by urethral relaxation , there is a more than 90 % chance that bladder instability will disappear after successful operation for stress urinary incontinence One hundred seven consecutive patients with clinical and urodynamic findings of genuine stress incontinence not previously treated were prospect ively allocated in a r and omized manner to one of three surgical procedures : anterior colporrhaphy , revised Pereyra procedure , or Burch retropubic urethropexy . R and omization included the surgical procedure and choice of surgeon ( one of the three authors ) . Clinical and urodynamic evaluations were repeated at 3 months and 1 year after surgery . Differences in cure rates among the three procedures at the 3-month postoperative evaluation were insignificant ( 82 % , 84 % , and 92 % for the anterior colporrhaphy , Pereyra , and Burch respectively ) but became statistically significant at the 1 year postoperative evaluation ( cure rates of 65 % , 72 % , and 91 % for the anterior colporrhaphy , Pereyra , and Burch respectively , p less than 0.05 ) . In our h and s the Burch procedure stabilized the urethrovesical junction and prevented its descent during straining ( evaluated by a postoperative Q-tip test ) more effectively than either the Pereyra or anterior colporrhaphy . No procedure result ed in severe postoperative voiding difficulties . The present prospect i ve r and omized study demonstrates that in our h and s the abdominal retropubic operation for genuine stress incontinence in patients not previously operated on results in a higher cure rate when compared with anterior colporrhaphy or Pereyra procedure OBJECTIVES To measure the effect on voiding pressure and flow rate of three different operations for stress urinary incontinence . METHODS In a previous study of cure rates , 289 women with genuine stress incontinence and genital prolapse were prospect ively allocated in a r and omized manner to one of three procedures : the Burch retropubic urethropexy , anterior repair , or the modified Pereyra procedure . In the current derivative study , we retrospectively evaluated the urodynamic indicators of voiding dysfunction in the original subjects preoperatively and at the 1-year postoperative follow-up visit . RESULTS One hundred thirty-two charts were available for review . One year after surgery , pressure and flow during voiding were altered to more obstructive levels with the suspension procedures ( Burch and modified Pereyra ) . The proportion of patients with obstructive and equivocal voiding patterns after the suspension procedures was significantly greater than after anterior repair . CONCLUSIONS This post hoc comparison of r and omized data shows a difference in postoperative voiding indexes between suspension procedures and anterior colporrhaphy . Successful bladder neck suspension depends on altering the pressure and flow during voiding to more obstructive levels . Suspension procedures alter the voiding pressure and flow toward obstruction to a greater extent than anterior repair OBJECTIVE : To estimate costs for incontinence management , health-related quality of life , and willingness to pay for incontinence improvement in women electing surgery for stress urinary incontinence . METHODS : A total of 655 incontinent women enrolled in the Stress Incontinence Surgical Treatment Efficacy Trial , a r and omized surgical trial . Baseline out-of-pocket costs for incontinence management were calculated by multiplying self-report of re sources used ( supplies , laundry , dry cleaning ) by national re source costs ( $ 2006 ) . Health-related quality of life was estimated with the Health Utilities Index Mark 3 . Participants estimated willingness to pay for 100 % improvement in incontinence . Potential predictors of these outcomes were examined by using multivariable linear regression . RESULTS : Mean age was 52±10 years , and mean number of weekly incontinence episodes was 22±21 . Mean and median ( 25 % , 75 % interquartile range ) estimated personal costs for incontinence management among all women were $ 14±$24 and $ 8 ( interquartile range $ 3 , $ 18 ) per week , and 617 ( 94 % ) women reported any cost . Costs increased significantly with incontinence frequency and mixed compared with stress incontinence . The mean and median Health Utilities Index Mark 3 scores were 0.73±0.25 and 0.84 ( interquartile range 0.63 , 0.92 ) . Women were willing to pay a mean of $ 118±$132 per month for complete resolution of incontinence , and willingness to pay increased significantly with greater expected incontinence improvement , household income , and incontinent episode frequency . CONCLUSION : Urinary incontinence is associated with substantial costs . Women spent nearly $ 750 per year out of pocket for incontinence management , had a significant decrement in quality of life , and were willing to pay nearly $ 1,400 per year for cure . LEVEL OF EVIDENCE : OBJECTIVES Stress urinary incontinence affects between 10 percent and 50 percent of women . Surgery is commonly recommended for troublesome incontinence that does not respond to nonsurgical management . Tension-free vaginal tape ( TVT ) is a newer , minimal access surgical sling procedure , which is being increasingly adopted worldwide . The cost-effectiveness of TVT in comparison with other surgical procedures , particularly open colposuspension , is assessed . METHODS Effectiveness estimates came from a systematic review of TVT compared with other surgical procedures ( open and laparoscopic colposuspension , traditional slings , and injectables ) . Deterministic and probabilistic analyses were used to assess the likelihood of TVT being cost-effective . Sensitivity analyses assessed the impact of changing assumptions about cure rates and costs for TVT , cure rates for retreatment open colposuspension , and proportions of women who choose retreatment . RESULTS Reliable estimates of relative effectiveness were difficult to derive because the few r and omized controlled comparisons had not been optimally analyzed or fully reported . Results of the economic model suggested that TVT dominates open colposuspension ( lower cost and same quality of life years [ QALYs ] ) within 5 years after surgery . Stochastic analysis indicated that the likelihood of TVT being cost-effective was 100 percent if decision-makers are unwilling to pay for additional QALYs . TVT 's dominance depended on the assumption fact that retreatment open colposuspension has lower cure rates than a first colposuspension . CONCLUSIONS Analysis based on current short-term data indicates dominance of TVT over open colposuspension from approximately 5 years . There is a need for longer-term follow-up data from method ologically rigorous r and omized trials to provide a sounder basis for estimating the relative benefits and cost implication Objective To determine the sensitivity and specificity of several urodynamic testing methods in the diagnosis of genuine stress urinary incontinence ( GSI ) . Methods One hundred eight consecutive patients were evaluated prospect ively by history and physical examination , cough stress test , and single and multichannel urodynamics . Sensitivities and specificities in detecting genuine stress incontinence were calculated for : a positive cough stress test with a negative cystometrogram , equalization throughout a cough urethral pressure profile , a positive stress leak-point pressure determination , observed urine loss with cough during multichannel urodynamics , and a pressure transmission ratio of less than 90 % for each third of the urethra . Results Sixty-five patients ( 60 % ) were found to have GSI . Observed urine loss with cough during multichannel studies was 91 % sensitive and 100 % specific . A positive stress leak-point pressure determination had a 78 % sensitivity and was 100 % specific . A positive cough stress test with a negative cystometrogram was 77 % sensitive and 100 % specific . Pressure equalization throughout the length of the urethra during a cough urethral pressure profile was 49 % sensitive and 98 % specific . A pressure transmission ratio of less than 90 % in the distal , middle , and proximal u
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| This effect was seen in both women with primary incontinence and women with recurrent incontinence after failed primary operations .
Needle suspensions may be as effective as anterior vaginal repair ( 50/156 ( 32 % ) failed after needle suspension versus 64/181 ( 35 % ) after anterior repair ; RR 0.86 , 95 % CI 0.64 to 1.16 ) , but there was little information about morbidity .
Bladder neck needle suspension surgery is probably not as good as open abdominal retropubic suspension for the treatment of primary and secondary urodynamic stress incontinence because the cure rates were lower in the trials review ed .
There was not enough information to comment on comparisons with suburethral sling operations .
A Brief Economic Commentary ( BEC ) identified no cost-effectiveness studies comparing bladder neck needle suspension with other surgeries |
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Input: BACKGROUND The Brief Motivational Intervention ( BMI ) is an effective treatment for alcohol misuse but has not been adequately tested for use in helplines for alcoholics . The main objective of this study was to evaluate the efficacy of a telephone-based BMI for Brazilians seeking help with alcohol use cessation . METHODS A r and omized , controlled trial was performed with Brazilian subjects . Participants were r and omly assigned to either the minimal intervention group ( i.e. , given reference material s ) or the BMI group . Alcohol abstinence was evaluated in a 6-month follow-up telephone counseling session . The analysis was based on the intention to treat ( ITT ) . RESULTS Of the 5,896 drug users who called the helpline , 700 ( 12 % ) used alcohol , 637 of whom enrolled in this study . At 6-month follow-up , 70 % of the BMI group had stopped consuming alcohol compared to 41 % in the control group ( odds ratio = 1.5 ; 95 % confidence interval = 1.2 - 1.9 ; p = 0.001 ) . CONCLUSIONS A helpline-based BMI helps alcohol users achieve abstinence Background In 2008 the World Health Organization ( WHO ) reported that South Africa had the highest tuberculosis ( TB ) incidence in the world . This high incidence rate is linked to a number of factors , including HIV co-infection and alcohol use disorders . The diagnosis and treatment package for TB and HIV co-infection is relatively well established in South Africa . However , because alcohol use disorders may present more insidiously , making it difficult to diagnose , those patients with active TB and misusing alcohol are not easily cured from TB . With this in mind , the primary purpose of this cluster r and omized controlled trial is to provide screening for alcohol misuse and to test the efficacy of brief interventions in reducing alcohol intake in those patients with active TB found to be misusing alcohol in primary health care clinics in three provinces in South Africa . Methods / Design Within each of the three selected health districts with the highest TB burden in South Africa , 14 primary health care clinics with the highest TB caseloads will be selected . Those agreeing to participate will be stratified according to TB treatment caseload and the type of facility ( clinic or community health centre ) . Within strata from 14 primary care facilities , 7 will be r and omly selected into intervention and 7 to control study clinics ( 42 clinics , 21 intervention clinics and 21 control clinics ) . At the clinic level systematic sampling will be used to recruit newly diagnosed TB patients . Those consenting will be screened for alcohol misuse using the AUDIT . Patients who screen positive for alcohol misuse over a 6-month period will be given either a brief intervention based on the Information-Motivation-Behavioural Skills ( IMB ) Model or an alcohol use health education leaflet . A total sample size of 520 is expected . Discussion The trial will evaluate the impact of alcohol screening and brief interventions for patients with active TB in primary care setting s in South Africa . The findings will impact public health and will enable the health ministry to formulate policy related to comprehensive treatment for TB and alcohol misuse , which will result in reduction in alcohol use and ultimately improve the TB cure rates . Trial registration numberPACTR : AIMS To assess the effectiveness of brief motivational intervention for alcohol and drug use in young adult primary care patients in a low-income population and country . METHODS A r and omized controlled trial in a public-sector clinic in Delft , a township in the Western Cape , South Africa recruited 403 patients who were r and omized to either single-session , nurse practitioner-delivered Brief Motivational Intervention plus referral list or usual care plus referral list , and followed up at 3 months . RESULTS Although rates of at-risk alcohol use and drug use did not differ by treatment arm at follow-up , patients assigned to the Brief Motivational Intervention had significantly reduced scores on ASSIST ( Alcohol , Smoking and Substance Involvement Screening Test ) for alcohol-the most prevalent substance . CONCLUSION Brief Motivational Intervention may be effective at reducing at-risk alcohol use in the short term among low-income young adult primary care patients ; additional research is needed to examine long-term outcomes Seven hundred and thirty one men admitted to medical wards were interviewed to identify problem drinkers who had not received previous treatment for alcoholism and who had some social support . One hundred and sixty one met the diagnostic criteria ; 156 agreed to a follow up interview and were allocated to one of two groups . One group received a session of counselling about their drinking habits from a nurse while the other received only routine medical care . Both groups reported a reduction in alcohol consumption when interviewed 12 months later , but the counselled group had a significantly better outcome than the control group . It is concluded that systematic screening for alcohol consumption and related problems should become a routine part of medical assessment and that advice on drinking habits is effective if given before irreversible physical or psychosocial problems have developed The aim of this study was to assess the effectiveness of Screening and Brief Intervention ( SBI ) for alcohol problems among university students in South Africa . The study design for this efficacy study is a r and omized controlled trial with 6- and 12-month follow-ups to examine the effects of a brief alcohol intervention to reduce alcohol use by hazardous and harmful drinkers in a university setting . The unit of r and omization is the individual university student identified as a hazardous or harmful drinker attending public recruitment venues in a university campus . University students were screened for alcohol problems , and those identified as hazardous or harmful drinkers were r and omized into an experimental or control group . The experimental group received one brief counseling session on alcohol risk reduction , while the control group received a health education leaflet . Results indicate that of the 722 screened for alcohol and who agreed to participate in the trial 152 ( 21.1 % ) tested positive for the Alcohol Use Disorder Identification Test ( AUDIT ) ( score 8 or more ) . Among the 147 ( 96.7 % ) university students who also attended the 12-month follow-up session , the intervention effect on the AUDIT score was −1.5 , which was statistically significant ( P = 0.009 ) . Further , the depression scores marginally significantly decreased over time across treatment groups , while other substance use ( tobacco and cannabis use ) , self-rated health status and Posttraumatic Stress Disorder ( PTSD ) scores did not change over time across treatment groups . The study provides evidence of effective brief intervention by assistant nurses with hazardous and harmful drinkers in a university setting in South Africa . The short duration of the brief intervention makes it a realistic c and i date for use in a university setting Background High prevalence rates of hazardous and harmful alcohol use have been found in a hospital outpatient setting in South Africa . Hospital setting s are a particularly valuable point of contact for the delivery of brief interventions because of the large access to patient population s each year . With this in mind , the primary purpose of this r and omized controlled trial is to provide screening for alcohol misuse and to test the effectiveness of brief interventions in reducing alcohol intake among hospital out patients in South Africa . Methods The study design for this effectiveness study is a r and omized controlled trial with 6- and 12-month follow-ups to examine the effects of a brief alcohol intervention to reduce alcohol use by hazardous or harmful drinkers in a hospital setting . Out patients were screened for alcohol problems , and those identified as hazardous or harmful drinkers were r and omized into an experimental or control group . The experimental group received one brief counselling session on alcohol risk reduction , while the control group received a health education leaflet . Results Of the 1419 screened for alcohol misuse who agreed to participate in the trial 392 ( 27.6 % ) screened positive for hazardous or harmful use on the Alcohol Use Disorder Identification Test ( AUDIT ) ( score 7/8 - 19 ) and 51 ( 3.6 % ) had an AUDIT score of 20 or more . Among the 282 ( 72 % ) hospital out patients who also attended the 12-month follow-up session , the time effects on the AUDIT scores were significant [ F ( 1,195 = 7.72 ) , P < 0.01 ] but the intervention effect on the AUDIT score was statistically not significant [ F ( 1,194 = 0.06 ) , P < 0.804 ] . Conclusion Given the lack of difference in outcome between control and intervention group , alcohol screening and the provision of an alcohol health education leaflet may in itself cause reduction in drinking . Trial registration At-risk alcohol use is increasing among women and it has been linked to important harm to their health . However , the effectiveness of brief intervention ( BI ) among women is unclear . Research on the most effective components of those interventions in the female population is necessary , especially in low and middle income countries . The aim of this study was to evaluate the impact of a BI , carried out among women in a household community setting , on their alcohol consumption . Participants were enrolled through a household survey , using a probabilistic sample of 905 adult women in the city of Juiz de Fora , Brazil . The 61 ( 6.7 % ) women who screened positive for at-risk drinking ( AUDIT score ≥ 8) were r and omly allocated to one of two groups : the Intervention Group ( n=32 ) , which received one single session of BI carried out in the household setting after screening , or the Control Group ( n=29 ) which did not receive BI . After three months , 46 ( 75.4 % ) participants completed the follow-up interview ( 23 in each group ) . All participants received an informative leaflet , and the Intervention Group received a 15 - 40 minute BI , which provided information on the adverse consequences of alcohol and strategies to help moderate consumption . Participants of both groups decreased their alcohol consumption after three months . The intervention group decreased the mean AUDIT score from 12.4 to 9.4 , while the control group reduced from 10.6 to 7.5 . Preliminary analyzes using general linear modelling indicate that there was no difference between the Intervention Group and the Control Group in relation to the main outcome ( total AUDIT score ) . Although no difference was found between groups , the results of this study are not conclusive and may reflect the small sample size of the trial . More studies are needed to better estimate the effectiveness of BI among women in a household setting Background The leading mental health causes of the global burden of disease are depression in women and alcohol use disorders in men . A major hurdle to the implementation of evidence -based psychological treatments in primary care in developing countries is the non-availability of skilled human re sources . The aim of these trials is to evaluate the effectiveness and cost-effectiveness of two psychological treatments developed for the treatment of depression and alcohol use disorders in primary care in India . Methods / design This study protocol is for parallel group , r and omized controlled trials ( Healthy Activity Program for moderate to severe depression , Counselling for Alcohol Problems for harmful and dependent drinking ) in eight primary health centres in Goa , India . Adult primary care attendees will be screened with the Patient Health Question naire for depression and , in men only , the Alcohol Use Disorders Identification Test for drinking problems . Screen-positive attendees will be invited to participate ; men who screen positive for both disorders will be invited to participate in the Counselling for Alcohol Problems trial . Those who consent will be allocated in a 1:1 ratio to receive either the respective psychological treatment plus enhanced usual care or enhanced usual care only using a computer generated allocation sequence , stratified by primary health centre and , for depression , by sex . The enhanced usual care comprises providing primary health centre doctors with context ualized World Health Organization guidelines and screening results . Psychological treatments will be delivered by lay counsellors , over a maximum period of three months . Primary outcomes are severity of disorder and remission rates at three months post-enrolment and , for the Counselling for Alcohol Problems trial , drinking and the impact of drinking on daily lives . Secondary outcomes include severity of disorder and remission rates at 12 months , disability scores , suicidal behaviour and economic impact , and cost-effectiveness at three and 12 months . 500 participants with depression and 400 participants with harmful drinking will be recruited . Primary analyses will be intention-to-treat . Discussion These trials may offer a new approach for the treatment of moderate-severe depression and drinking problems in primary care that is potentially scalable as it relies on delivery by a single pool of lay counsellors . Trial registration Both trials are registered with the International Society for the Registration of Clinical Trials ( Healthy Activity Programme registration number IS RCT N95149997 ; Counselling for Alcohol Problems registration number IS RCT N76465238 ) Background The aim of this study was to conduct a cluster r and omized control trial to assess the efficacy of screening and brief intervention ( SBI ) for conjoint alcohol and tobacco use among hospital out- patients . Method In all 620 hospital out- patients who screened positive for both tobacco and alcohol moderate risk in four hospitals were r and omized into 2 control and 1 intervention condition using the hospital as a unit of r and omization ( 2 intervention and 2 control hospitals ) to 405 patients in the two control groups ( tobacco only intervention , n = 199 , and alcohol only intervention , n = 206 ) and 215 in the intervention group . The intervention or control consisted of three counselling sessions . Results Results of the interaction ( Group × Time ) effects using GEE indicated that there were statistically significant differences between the three study groups over the 6-month follow-up on the ASSIST tobacco score ( Wald χ2 = 8.43 , P = 0.004 ) , and past week tobacco
Output:
| Conclusion This systematic review of RCTs on alcohol brief intervention conducted in middle-income countries suggests that brief intervention can help reduce self-reported hazardous or harmful alcohol use in primary -care population |
MS211483 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
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Input: Hypertension following coronary artery bypass grafting is not uncommon , especially in patients having good left ventricular function . It is often accompanied by tachycardia . The purpose of this study is to determine the efficacy of esmolol in the treatment of tachycardia and hypertension immediately following cardiopulmonary bypass and to study other haemodynamic effects of esmolol . Thirty patients undergoing elective [ corrected ] coronary artery bypass grafting were included in this prospect i ve study . Morphine-based anaesthetic technique along-with st and ard bypass techniques were used in all the patients . The study was performed in the operating room about 30 - 45 minutes after the termination of cardiopulmonary bypass . Patients having a heart rate of more than 90 bpm and systolic blood pressure of more than 130 mm Hg without any inotropic support were included and r and omly assigned to esmolol or control group . Esmolol was administered in a bolus dose of 500 micrograms/kg followed by infusion of upto 100 micrograms/kg/min . The patients in the control group were administered comparable volumes of normal saline . Baseline haemodynamic measurements were obtained just before the administration of esmolol or normal saline and were repeated after 5 , 10 , 15 , 30 and 45 min . The baseline measurement in both the groups showed that patients were maintaining a state of hyperdynamic circulation with high systolic blood pressure ( esmolol group 148 + /- 15 mm Hg , control group 140 + /- 8 mm Hg ; p = NS ) , heart rate ( esmolol group 128 + /- 17 bpm , control group 127 + /- 17 bpm ; p = NS ) and cardiac index ( esmolol group 3.1 + /- 1 L/min/m2 , control group 3.3 + /- 0.5 L/min/m2 ; p = NS ) . Esmolol decreased systolic blood pressure ( p < 0.001 ) , heart rate ( p < 0.01 ) and cardiac index ( p < 0.05 ) at five minutes . These changes persisted throughout the study period . The left ventricular stroke work index decreased at five minutes ( p < 0.05 ) and remained so till 30 minutes . The maximum fall in heart rate ( 15 % ) and systolic blood pressure ( 16 % ) was observed at 45 minutes . There were no haemodynamic changes in the control group except that cardiac index , stroke volume and left ventricular stroke work index increased at five minutes . We conclude that esmolol lowers the indices of cardiovascular work in patients who demonstrated hyperdynamic circulation . This was achieved by decreasing the heart rate and systolic blood pressure which was accompanied by decrease in cardiac index and left ventricular stroke work index Background Perioperative opioid administration results in postoperative nausea and vomiting ( PONV ) and acute opioid tolerance that manifests in increased postoperative pain . Esmolol is an ultra short acting cardioselective β1-adrenergic receptor antagonist , and it has been successfully used for perioperative sympatholysis and it reduces the opioid requirement during total intravenous anesthesia . We tested the hypothesis that perioperative esmolol administration results in decreased PONV and postoperative pain . Methods Sixty patients undergoing laparoscopic appendectomy were r and omly assigned to two groups ( Group E and Group C ) . The Group E patients were administered 5 - 10 µg/kg/min esmolol with remifentanil that was titrated to the autonomic response . The Group C patients received normal saline that was of the same volume as the esmolol in Group E , and the remifentanil was also titrated to the vital sign . Before intubation and extubation , the Group E patients were administered 1.0 mg/kg esmolol , and the Group C patients were administered normal saline of the same volume . The incidence and severity of PONV , the pain score , the rescue antiemetics and the rescue analgesics were assessed 30 min , 6 h and 24 h after surgery . The mean arterial pressure and heart rate under anesthesia were also recorded . Results PONV and postoperative pain were significantly increased in Group C. These patients needed more antiemetics and analgesics in the first 24 postoperative hours . The mean arterial pressure and heart rate were significantly higher in Group C at the time of intubation and extubation . Conclusions Perioperative esmolol administration contributes to the significant decrease in PONV and postoperative pain , and so this facilitates earlier discharge Objectives : Atrial fibrillation after cardiac surgery is associated with increases in the risk of complications , length of intensive care unit stay , and cost of care . Beta blockers are effective for controlling myocardial ischemia and arrhythmia and suppressing inflammatory cytokines . The purpose of this study was to examine the effect of administrating a short-acting beta-adrenoceptor antagonist , l and iolol , on postoperative atrial fibrillation . Methods : 136 patients undergoing off-pump coronary artery bypass grafting were single-blindly assigned r and omly to l and iolol ( n = 68 ) and non-l and iolol ( control , n = 68 ) groups . In the l and iolol group , the beta blocker was administered from the beginning of the operation until postoperative day 2 . The primary endpoint was the incidence of atrial fibrillation until postoperative day 7 , and the secondary endpoints were the postoperative levels of troponin I , creatine kinase MB-isoenzyme , and C-reactive protein . Results : The incidence of atrial fibrillation was significantly lower in the l and iolol group compared to the control group ( 13/68 , 19 % vs. 25/68 , 37 % , p = 0.02 , logrank test ) . L and iolol also significantly reduced the postoperative peak C-reactive protein level compared to the control group ( 132 ± 55.4 vs. 161 ± 50.9 mgċL−1 , p = 0.004 ) . Conclusion : Low-dose continuous infusion of l and iolol reduced the incidence of postoperative atrial fibrillation , and significantly suppressed inflammation The safety and efficacy of esmolol during high-dose fentanyl anesthesia were studied in 37 patients undergoing coronary artery bypass grafting ( CABG ) . The anesthetic management consisted of fentanyl 75 μg/kg , pancuronium 0.15 mg/kg , and O2 . To assess the safety of esmolol , it was administered in a double-blind manner to 17 anesthetized patients prior to surgical incision . Infusion of the drug was increased in stepwise fashion to obtain administration rates between 100 and 300 μg · kg−1 ' min−1 . Esmolol produced smail but significant increases in pulmonary capillary wedge pressure ( PCWP ) ( 8.3 ± 1.7 to 13.2 ± 2.0 mmHg ) when compared with placebo ( 10.9 ± 1.0 to 12.1 ± 0.6 mmHg ) ( P < 0.05 ) . For the other studied parameters ( heart rate , mean arterial pressure , central venous pressure , cardiac index , stroke index , left ventricular stroke work index , systemic vascular resistance , and peripheral vascular resistance ) , no significant differences were observed between esmolol and placebo . To evaluate the efficacy of esmolol , 20 patients were r and omly assigned to an esmolol group ( n = 11 ) or a placebo group ( n = 9 ) . The study medication was infused from 5 min before induction through initiation of cardiopulmonary bypass . Infusion of esmolol at 200 μg · kg−1 · min−1 prevented tachycardia in response to intubation . In the esmolol group the heart rate increased from 63.4 ± 2.7 to 67.6 ± 2.9 beats/min after intubation , while in the placebo group it increased from 61.4 ± 4.3 to 72.4 ± 3.4 beats/min ( P < 0.05 ) . Furthermore , the increases in mean pulmonary artery pressure and PCWP observed in unstimulated , anesthetized patients were absent during surgical stimulation . Thus , in CABG patients anesthetized with fentanyl , esmolol appears safe and effective in preventing increases in heart rate during stimulation OBJECTIVE To assess the effectiveness of labetalol vs dexmedetomidine for attenuation of hemodynamic stress response to laryngoscopy and endotracheal intubation . DESIGN Prospect i ve , r and omized , controlled , observer-blinded study . SETTING This study was carried out in Tanta University Hospital . PATIENTS Ninety patients of both sexes ; American Society of Anesthesiologists physical status I and II ; age range from 20 to 60 years ; scheduled for elective surgery under general anesthesia . INTERVENTIONS Patients were divided into 3 groups ( 30 each ) . Group A received 1 μg/kg of dexmedetomidine as intravenous ( IV ) infusion , group B received labetalol 0.25mg/kg IV , and group C received 10mL saline IV . MEASUREMENTS The groups were compared for heart rate ( HR ) , mean arterial pressure ( MAP ) , and rate pressure product ( RPP ) . Hemodynamic parameters were recorded during the preinduction ; after induction ; at intubation ; and at 1 , 3 , 5 , 10 , and 15minutes . The primary outcomes were hemodynamic changes ( HR , MBP , and RPP ) , and the secondary outcome was propofol dose requirement for induction of general anaesthesia . RESULTS Significant decrease ( P < .05 ) in HR , MBP , and RPP in groups A and B in comparison with group C and in group A in comparison with group B. Just before intubation , there was a significant decrease ( P < .05 ) in HR , MBP , and RPP in groups A and B in comparison with group C. In group C , there was a significant increase in HR , MBP , and RPP at all points when compared with the baseline . In group A , the mean propofol induction dose ( mg ) was statistically significantly low as compared with that in groups B and C. CONCLUSION Dexmedetomidine attenuates the hemodynamic stress response to laryngoscopy and intubation more effectively compared with labetalol without any deleterious effects . Furthermore , dexmedetomidine decreases dose of propofol for induction of anesthesia as guided by bispectral index OBJECTIVES We previously conducted a prospect i ve study of l and iolol hydrochloride ( INN l and iolol ) , an ultrashort-acting β-blocker , and reported that it could prevent atrial fibrillation after cardiac surgery . This trial was performed to investigate the safety and efficacy of l and iolol hydrochloride in patients with left ventricular dysfunction undergoing cardiac surgery . METHODS Sixty patients with a preoperative left ventricular ejection fraction of less than 35 % were r and omly assigned to 2 groups before cardiac surgery and then received intravenous infusion with l and iolol hydrochloride ( l and iolol group ) or without l and iolol ( control group ) . The primary end point was occurrence of atrial fibrillation as much as 1 week postoperatively . The secondary end points were blood pressure , heart rate , intensive care unit and hospital stays , ventilation time , ejection fraction , biomarkers of ischemia , and brain natriuretic peptide . RESULTS Atrial fibrillation occurred in 3 patients ( 10 % ) in the l and iolol group versus 12 ( 40 % ) in the control group , and its frequency was significantly lower in the l and iolol group ( P = .002 ) . During the early postoperative period , levels of brain natriuretic peptide and ischemic biomarkers were significantly lower in the l and iolol group than the control group . The l and iolol group also had a significantly shorter hospital stay ( P = .019 ) . Intravenous infusion was not discontinued for hypotension or bradycardia in either group . CONCLUSIONS Low-dose infusion of l and iolol hydrochloride prevented atrial fibrillation after cardiac surgery in patients with cardiac dysfunction and was safe , with no effect on blood pressure . This intravenous β-blocker seems useful for perioperative management of cardiac surgical patients with left ventricular dysfunction BACKGROUND Trials of beta blockers in patients undergoing non-cardiac surgery have reported conflicting results . This r and omised controlled trial , done in 190 hospitals in 23 countries , was design ed to investigate the effects of perioperative beta blockers . METHODS We r and omly assigned 8351 patients with , or at risk of , atherosclerotic disease who were undergoing non-cardiac surgery to receive extended-release metoprolol succinate ( n=4174 ) or placebo ( n=4177 ) , by a computerised r and omisation phone service . Study treatment was started 2 - 4 h before surgery and continued for 30 days . Patients , health-care providers , data collectors , and outcome adjudicators were masked to treatment allocation . The primary endpoint was a composite of cardiovascular death , non-fatal myocardial infa rct ion , and non-fatal cardiac arrest . Analyses were by intention to treat . This trial is registered with Clinical Tri
Output:
| We found no evidence of a difference in early all-cause mortality , myocardial infa rct ion , cerebrovascular events , hypotension and bradycardia .
However , there may be a reduction in atrial fibrillation and ventricular arrhythmias when beta-blockers are used . |
MS211484 | ***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 anxiolytic effect of Silexan , a patented active substance with an essential oil produced from Lav and ula angustifolia flowers , was investigated in patients with anxiety-related restlessness and disturbed sleep . 170 out- patients with a diagnosis of restlessness ( ICD-10 R45.1 ) , a Hamilton Anxiety Scale ( HAMA ) total score ≥18 points and ≥2 points for HAMA items ' Tension ' and ' Insomnia ' participated in this r and omized , double-blind trial and received 80 mg Silexan or placebo once daily for 10 weeks . Patients with clinical ly important other psychiatric or neurological disorders potentially interfering with the assessment of treatment efficacy were excluded . Outcome variables were the HAMA as well as the Pittsburgh Sleep Quality Index ( PSQI ) , the Zung Self-rating Anxiety Scale , a State Check inventory and the Clinical Global Impressions question naire . In the Silexan group the HAMA total score decreased from an average of 25.5±6.0 points at baseline to 13.7±7.0 points at treatment end , compared to a decrease from 26.5±6.1 to 16.9±9.8 for placebo , corresponding to decreases of 12.0 and 9.3 points ( marginal means ) , respectively ( group difference : p=0.03 , ANCOVA with factor treatment and baseline value as covariate ) . In all outcome measures the treatment effect of Silexan was more pronounced than with placebo . According to the HAMA , 48.8 % and 33.3 % of the patients were responders ( Silexan , placebo ; reduction ≥50 % ; p=0.04 ) and 31.4 % and 22.6 % achieved remission ( HAMA<10 ; p=0.20 ) . 33.7 % ( Silexan ) and 35.7 % ( placebo ) of the participants reported adverse events . The study confirms the calming and anxiolytic efficacy of Silexan Mixed anxiety and depressive disorder ( MADD ; ICD-10 F41.2 ) is a condition characterized by subsyndromal symptoms of anxiety and depression , neither of which are clearly predominant . Silexan has been demonstrated to be efficacious in subsyndromal and syndromal anxiety disorders and co-morbid depressive symptoms . In this study 318 adult out- patients with MADD according to ICD-10 criteria , a total score ≥18 points on the Hamilton Anxiety Rating Scale ( HAMA ) , and at least moderately severe anxious and depressed mood were r and omized and received 1 × 80 mg Silexan or placebo in double-blind fashion for a scheduled period of 70 days . Primary outcome measures were the HAMA and Montgomery Åsberg Depression Rating Scale ( MADRS ) total score changes between baseline and treatment end . The HAMA total score decreased by 10.8±9.6 points for Silexan and by 8.4±8.9 points for placebo ( treatment group difference : p<0.01 , one-sided ; ANCOVA with factors for treatment and centre and the baseline value as covariate ) , and total score decreases of 9.2±9.9 and 6.1±7.6 points , respectively , were observed for the MADRS ( p<0.001 ) . Compared to placebo , the patients treated with Silexan had a better over-all clinical outcome and showed more pronounced improvements of impaired daily living skills and health related quality of life . Eructation was the only adverse event with a substantially higher incidence under Silexan . The study thus demonstrates that Silexan is efficacious and safe in the treatment of MADD Background : Open heart surgery can cause high levels of anxiety in patients . Nowadays , lavender essential oil is widely used in medical research . This study was conducted with an aim to investigate the effects of lavender essential oil to reduce the anxiety of patients after coronary artery bypass surgery . Material s and Methods : This research is double-blinded r and omized controlled trial on 60 patients who had undergone coronary artery bypass surgery in a 2-day intervention targeting reduction of anxiety . This study was conducted in Ekbatan Therapeutic and Educational Center , Hamadan city , Iran , in 2013 . The patients in the inhalation aromatherapy group inhaled two drops of 2 % lavender essential oil and those in the control group inhaled two drops of distilled water as placebo for 20 min on the 2nd and 3rd days after surgery . The level of anxiety was evaluated by Spielberger 's State Anxiety question naire before and after intervention and the vital signs were documented as well . Data were analyzed using Stata 11 ( Stata Corp. , College Station , TX , USA ) by independent t-test for continuous variables and Chi-square test for categorical variables . Results : The mean score of anxiety in the aromatherapy group was 48.73 ± 5.08 and in the control group was 48 ± 6.98 before the intervention ( P = 0.64 ) , which reduced after the intervention to 42.6 ± 5.44 and 42.73 ± 7.30 , respectively . On the 3rd day after surgery , the mean score of anxiety in the aromatherapy group was 46.76 ± 4.07 and in the control group was 46.53 ± 7.05 before the intervention , which reduced to 41.33 ± 3.65 and 41.56 ± 6.18 , respectively , after the intervention . However , there was no statistically significant difference in the mean scores of anxiety between the aromatherapy and control groups . Conclusions : Lavender essential oil has no significant effect on anxiety in patients after coronary artery bypass surgery , although it decreased the level of anxiety in the patients BACKGROUND Anxiety and pain are recognized as major problems of burn patients ; because pharmaceutical treatments for controlling anxiety and pain symptoms lead to complications and an increase in health costs , nonpharmacological nursing interventions were considered for this group of patients . This led to the present study aim ed at comparing the effect of aromatherapy massage with inhalation aromatherapy for anxiety and pain in burn patients . METHODS This single-blind clinical trial was carried out on 90 patients with burns < 20 % . Patients were r and omly assigned to one of three groups , namely aromatherapy massage , inhalation aromatherapy , and control group . The patients assigned to the aromatherapy massage group received a massage for half an hour using a blend of lavender and almond oils , while a blend of rose and lavender aroma was used for the inhalation aromatherapy group . Spielberger State Anxiety Inventory was used for measuring anxiety and the visual analog scale ( VAS ) scale was used for measuring pain . RESULTS The results showed that three groups were equal in terms of demographics , disease characteristics , and scores of anxiety and pain at the baseline . The mean decreases of anxiety scores were -0.04±5.08 , 6.33±12.55 , and 6.43±10.60 in the control group , aromatherapy massage group , and inhalation group , respectively ( p=0.007 ) . The mean decrease of pain scores were -0.10±0.96 , 1.70±1.84 , and 0.97±1.56 in the control group , aromatherapy massage group , and inhalation group , respectively ( p<0.001 ) . CONCLUSION The study results showed the positive effect of aromatherapy massage and inhalation aromatherapy compared with the control group in reducing both anxiety and pain of burn patients . Therefore , both interventions , which are inexpensive , and noninvasive nursing tasks can be proposed for alleviating anxiety and pain of burn patients Background : Recently , Silexan , a patented active substance comprised of an essential oil produced from Lav and ula angustifolia flowers , has been authorized in Germany as a medicinal product for the treatment of states of restlessness related to anxious mood . Its efficacy has been shown in several forms of anxiety disorders . Findings from pre clinical and clinical studies attribute a major role to the serotonin-1A receptor in the pathogenesis and treatment of anxiety . Methods : To eluci date the effect of Silexan on serotonin-1A receptor binding , 17 healthy men underwent 2 positron emission tomography measurements using the radiolig and [carbonyl-11C]WAY-100635 following the daily intake of 160 mg Silexan or placebo for a minimum of 8 weeks ( r and omized , double-blind , cross-over design ) . Additionally , structural magnetic resonance imaging and voxel-based morphometry analysis was performed to determine potential effects on gray matter microstructure . Results : Serotonin-1A receptor binding potential was shown to be significantly reduced following the intake of Silexan compared with placebo in 2 large clusters encompassing the temporal gyrus , the fusiform gyrus and the hippocampus on one h and as well as the insula and anterior cingulate cortex on the other h and . No effects of Silexan on gray matter volume could be detected in this investigation . Conclusion : This positron emission tomography study proposes an involvement of the serotonin-1A receptor in the anxiolytic effects of Silexan . The study was registered in the International St and ard R and omized Controlled Trial Number Register as IS RCT N30885829 ( http://www.controlled-trials.com/is rct n/ ) Background : Surgery , as a treatment , is a stressful experience . The anxiety is more severe in open-heart surgery patients due to its risk and complications . The present study aim ed to determine the effect of lavender essence on the levels of anxiety and blood cortisol in c and i date s for open-heart surgery . Material s and Methods : This was a single-blind clinical trial , a r and om allocation study with a control group conducted on 90 c and i date s for open-heart surgery in two groups of study and control . The study and control groups inhaled two drops of lavender and distilled water for 20 min , respectively . Spielberger question naire was filled by the patients . A 2 ml blood sample was taken to measure the cortisol level and patients ′ vital signs were recorded before and after intervention . Data were analyzed by chi-square in the form of mean , SD , and frequency distribution , independent t-test , paired t-test , and analysis of covariance ( ANCOVA ) , with a significance level of P = 0.05 to modify the pre-test scores . Results : Results showed a significant reduction in mean anxiety score from 56.73 ( 5.67 ) to 54.73 ( 5.42 ) after intervention in the study group , compared to the control group [ 1.11 ( 1.17 ) ] ( P < 0.001 ) . There was also a higher difference in cortisol level in the study group compared to the control group [ 1.88 ( 0.56 ) vs. 0.42 ( 0.45 ) ] . ANCOVA test showed that the 10.8 % variance in anxiety score and 69.6 % decrease in blood cortisol result ed from inhalation of lavender . Conclusions : Results showed the positive effect of lavender essence on anxiety and blood cortisol level among the patients . Aromatherapy with lavender is suggested to be considered as a nursing intervention in clinical setting Research suggests that patients with cancer , particularly in the palliative care setting , are increasingly using aromatherapy and massage . There is good evidence that these therapies may be helpful for anxiety reduction for short periods , but few studies have looked at the longer term effects . This study was design ed to compare the effects of four-week courses of aromatherapy massage and massage alone on physical and psychological symptoms in patients with advanced cancer . Forty-two patients were r and omly allocated to receive weekly massages with lavender essential oil and an inert carrier oil ( aromatherapy group ) , an inert carrier oil only ( massage group ) or no intervention . Outcome measures included a Visual Analogue Scale ( VAS ) of pain intensity , the Verran and Snyder-Halpern ( VSH ) sleep scale , the Hospital Anxiety and Depression ( HAD ) scale and the Rotterdam Symptom Checklist ( RSCL ) . We were unable to demonstrate any significant long-term benefits of aromatherapy or massage in terms of improving pain control , anxiety or quality of life . However , sleep scores improved significantly in both the massage and the combined massage ( aromatherapy and massage ) groups . There were also statistically significant reductions in depression scores in the massage group . In this study of patients with advanced cancer , the addition of lavender essential oil did not appear to increase the beneficial effects of massage . Our results do suggest , however , that patients with high levels of psychological distress respond best to these therapies Background : Anxiety is an important mental health problem in patients with cardiac disease . Anxiety reduces patients ’ quality of life and increases the risk of different cardiac complications . Objectives : The aim of this study was to investigate the effects of inhalation aromatherapy on anxiety in patients with myocardial infa rct ion . Patients and Methods : This was a r and omized clinical trial conduced on 68 patients with myocardial infa rct ion hospitalized in coronary care units of a large-scale teaching hospital affiliated to Kashan University of Medical Sciences , Kashan , Iran in 2013 . By using the block r and omization technique , patients were r and omly assigned to experimental ( 33 patients receiving inhalation aromatherapy with lavender aroma twice a day for two subsequent days ) and control ( 35 patients receiving routine care of study setting including no aromatherapy ) groups . At the beginning
Output:
| Overall , silexan 160 mg was noticed to be a more efficient treatment giving significant decline in HAMA score across other comparators . |
MS211485 | ***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 psychological response to breast cancer , such as a fighting spirit or an attitude of helplessness and hopelessness toward the disease , has been suggested as a prognostic factor with an influence on survival . We have investigated the effect of psychological response on disease outcome in a large cohort of women with early-stage breast cancer . METHODS 578 women with early-stage breast cancer were enrolled in a prospect i ve survival study . Psychological response was measured by the mental adjustment to cancer ( MAC ) scale , the Courtauld emotional control ( CEC ) scale , and the hospital anxiety and depression ( HAD ) scale 4 - 12 weeks and 12 months after diagnosis . The women were followed up for at least 5 years . Cox 's proportional-hazards regression was used to obtain the hazard ratios for the measures of psychological response , with adjustment for known clinical factors associated with survival . FINDINGS At 5 years , 395 women were alive and without relapse , 50 were alive with relapse , and 133 had died . There was a significantly increased risk of death from all causes by 5 years in women with a high score on the HAD scale category of depression ( hazard ratio 3.59 [ 95 % CI 1.39 - 9.24 ] ) . There was a significantly increased risk of relapse or death at 5 years in women with high scores on the helplessness and hopelessness category of the MAC scale compared with those with a low score in this category ( 1.55 [ 1.07 - 2.25 ] ) . There were no significant results found for the category of " fighting spirit " . INTERPRETATION For 5-year event-free survival a high helplessness/hopelessness score has a moderate but detrimental effect . A high score for depression is linked to a significantly reduced chance of survival ; however , this result is based on a small number of patients and should be interpreted with caution PURPOSE Evidence that psychosocial status and health-related quality of life ( HRQOL ) are associated with breast cancer ( BC ) outcomes is weak and inconsistent . We examined prognostic effects of these factors in a prospect i ve cohort study . PATIENTS AND METHODS Three hundred ninety-seven women with surgically resected T1 to T3 , N0/N1 , M0 BC completed the European Organization for Research and Treatment of Cancer Quality of Life Question naire ( Core 30 items ) , Profile of Mood States , Psychosocial Adjustment to Illness Scale , Impact of Events Scale , Mental Adjustment to Cancer Scale , and the Courtauld Emotional Control Scale 2 months after diagnosis and 1 year later . Data on tumor-related factors , treatment , and outcomes were obtained prospect ively from medical records , and Cox survival analyses were performed . RESULTS Mean age was 52.0 + /- 9.9 years . Two hundred twenty-five women had T1 , 136 women had T2 , 16 women had T3 , and 20 women had TX tumors ; 127 were N1 . One hundred thirteen women received adjuvant chemotherapy , 130 received hormone therapy , 45 received both , and 109 received neither . We investigated 140 prognostic associations ; four were found to be statistically significant at a P value of < /= .05 ( three fewer than expected by chance ) . Two were in the hypothesized direction of effect , and two were in the opposite direction . All arose from measurements 1 year after diagnosis , which were most susceptible to confounding by treatment . There was no evidence of consistency of associations across outcomes or question naires . These results are in keeping with chance as the explanation for our statistically significant findings . CONCLUSION HRQOL and psychosocial status at diagnosis and 1 year later are not associated with medical outcome in women with early-stage BC The current study assessed main effects and moderators ( including emotional expressiveness , emotional processing , and ambivalence over emotional expression ) of the effects of expressive writing in a sample of healthy adults . Young adult participants ( N=116 ) were r and omly assigned to write for 20 minutes on four occasions about deepest thoughts and feelings regarding their most stressful/traumatic event in the past five years ( expressive writing ) or about a control topic ( control ) . Dependent variables were indicators of anxiety , depression , and physical symptoms . No significant effects of writing condition were evident on anxiety , depressive symptoms , or physical symptoms . Emotional expressiveness emerged as a significant moderator of anxiety outcomes , however . Within the expressive writing group , participants high in expressiveness evidence d a significant reduction in anxiety at three-month follow-up , and participants low in expressiveness showed a significant increase in anxiety . Expressiveness did not predict change in anxiety in the control group . These findings on anxiety are consistent with the matching hypothesis , which suggests that matching a person 's naturally elected coping approach with an assigned intervention is beneficial . These findings also suggest that expressive writing about a stressful event may be contraindicated for individuals who do not typically express emotions This investigation examined relationships between breast cancer patients ' psychosocial characteristics ( impact of the illness , traumatic stress symptoms , emotional self-efficacy , and social support ) and problems they perceived in their medical interactions and their satisfaction with their physicians . Participants were 352 women enrolled in a multicenter trial of the effects of group therapy for women with recently diagnosed primary breast cancer . The findings reported here are from a cross-sectional analysis of baseline data gathered prior to r and omization . Problems interacting with physicians and nurses were associated with greater levels of cancer-related traumatic stress ( p < 0.01 ) , less emotional self-efficacy for cancer ( p < 0.05 ) , less satisfaction with informational support from family , friends , and spouse , and a tendency to perceive those sources of support as more aversive ( p < 0.05 ) . Women who were less satisfied with emotional support from their family , friends and spouse were less likely to feel satisfied with their physicians ( p < 0.05 ) . These patient characteristics identify women with primary breast cancer who are likely to experience difficulty in their interactions with nurses and physicians and to be less satisfied with their physicians OBJECTIVE The purpose was to examine whether social-cognitive variables would moderate the efficacy of a couple-focused group intervention ( CG ) for women diagnosed with early stage breast cancer . DESIGN Participants ( N = 238 ) were r and omly assigned to 6 sessions of a couple-focused group versus usual care . Intent to treat growth curve modeling analyses indicated that emotional expression and emotional processing moderated CG effects on depression . MAIN OUTCOME MEASURES The primary outcome measures for this study were psychological distress and psychological well-being . RESULTS Treatment attrition analyses separating out participants assigned to but not attending CG indicated that emotional expression , emotional processing , and protective buffering moderated the effects of CG among those who attended CG with the most consistent effects noted for emotional processing on indicators of distress and well-being . CONCLUSION The CG intervention may be more effective for patients who begin the group experience using emotional approach coping strategies to deal with cancer Abstract This study aim ed to investigate the psychophysiological outcomes of different psychosocial interventions for breast cancer patients . Participants were r and omly assigned into 3 intervention groups , namely , Body-Mind-Spirit ( BMS ) , Supportive-Expressive ( SE ) , and Social Support Self-Help ( SS ) groups ; a no-intervention group was used as control . Salivary cortisol was used as the physiological stress marker . Distress level , mental adjustment , emotional control , and social support were measured . Data were collected at baseline , 4 month , and 8 month . Preliminary results indicated that BMS intervention produced the greatest and the most sustained effects . It enhanced positive social support , reduced psychological distress , emotional control , and negative mental adjustment . Total salivary cortisol was lowered after 8 months . Most participants in SE groups indicated the treatment helpful , but changes in psychophysiological outcomes were not statistically significant . Participants in SS groups seemed less likely to benefit from the intervention . The no intervention control group indicated a reduction in social support . These outcomes suggest that active professional intervention is more likely to yield therapeutic effects . In particular , psychosocial intervention attending to the spiritual dimension contributes to positive outcomes Women with breast cancer express the greatest need for counseling at the time of diagnosis and report that the intervention they want is to be able to speak with someone who has the same cancer , but has lived through the crisis of treatment and is leading a ' normal ' life . We conducted an observational study of a 6-month peer-counseling intervention testing outcomes for both newly diagnosed women ( Sojourners ) and peer counselors ( Navigators ) as a first step toward the goal of validating a peer navigator program . Significant improvement in the Sojourners was observed in trauma symptoms , emotional well-being , cancer self-efficacy , and desire for information on breast cancer re sources . Navigators maintained baseline levels of the outcome variables , but increased in dissatisfaction with their interactions with their medical team and increased emotional suppression . Our findings indicate that peer navigation may halt a decline in quality of life that is commonly found in the first year following breast cancer diagnosis . In addition , Navigators were not adversely affected by their experience ; however , careful training and supervision of Navigators is crucial to overall success . R and omized clinical trials are needed to demonstrate the efficacy of peer navigator programs Purpose . To testthe relative effectiveness of a mindfulness-based stress reduction program ( MBSR ) compared with a nutrition education intervention ( NEP ) and usual care ( UC ) in women with newly diagnosed early-stage breast cancer (BrCA)undergoing radiotherapy . Methods . Data were available from a r and omized controlled trialof 172 women , 20 to 65 years old , with stage I or II BrCA . Data from women completing the 8-week MBSR program plus 3 additional sessions focuses on special needs associated with BrCA were compared to women receiving attention control NEP and UC . Follow-up was performed at 3 post-intervention points : 4 months , and 1 and 2 years . St and ardized , vali date d self-administered question naires were used to assess psychosocial variables . Descriptive analyses compared women by r and omization assignment . Regression analyses , incorporating both intention-to-treat and post hoc multivariable approaches , were used to control for potential confounding variables . Results . A subset of 120 women underwent radiotherapy ; 77 completed treatment prior to the study , and 40 had radiotherapy during the MBSR intervention . Women who actively received radiotherapy ( art ) while participating in the MBSR intervention ( MBSR-art ) experienced a significant ( P < .05 ) improvement in 16 psychosocial variables compared with the NEP-art , UC-art , or both at 4 months . These included health-related , BrCA-specific quality of life and psychosocial coping , which were the primary outcomes , and secondary measures , including meaningfulness , helplessness , cognitive avoidance , depression , paranoid ideation , hostility , anxiety , global severity , anxious preoccupation , and emotional control . Conclusions . MBSR appears to facilitate psychosocial adjustment in BrCA patients receiving radiotherapy , suggesting applicability for MBSR as adjunctive therapy in oncological practice A r and omized trial ( n = 60 ; A. L. Stanton , S. Danoff-Burg , L. A. Sworowski , et al. , 2002 ) revealed that 4 sessions of written expressive disclosure or benefit finding produced lower physical symptom reports and medical appointments for cancer-related morbidities at 3-month follow-up among breast cancer patients relative to a fact-control condition . The goal of this article is to investigate mechanisms underlying these effects . Within-session heart rate habituation mediated effects of expressive disclosure on physical symptoms , and greater use of negative emotion words in essays predicted a decline in physical symptoms . Postwriting mood and use of positive emotion and cognitive mechanism words in essays were not significant mediators , although greater cognitive mechanism word use was related to greater heart rate habituation and negative emotion word use Background : Previous studies of cancer patients investigated the effect of psychological treatment on basal endocrine and immune values . Using a r and omized experiment , we explored the effect of a 13-week experiential-existential group psychotherapy ( EEGP ) program on the reactivity to a speech task in breast cancer patients . We explored whether changes in cardiovascular and immune reactivity to a speech task over the 3-month period correlated with changes in psychological distress and emotional expression . Methods : Patients who had been treated for early-stage breast cancer and who were diagnosed as having either positive axillary lymph nodes or distant metastases were r and omly assigned to either EEGP or a waiting list control ( WLC ) condition . We continuously recorded heart rate ( HR ) , diastolic ( DBP ) and systolic blood pressure ( SBP ) in response to the speech task before and after treatment . We also measured lymphocyte proliferation to pokeweed ( PWM ) and phytohemagglutinin ( PHA ) , and natural killer cell activity ( NKCA ) as well as peripheral blood lymphocyte distributions in blood sample s that were drawn before , during and after the speech task . Results : Patients in EEGP had smaller increases in natural killer ( NK ) cells induced by the speech task after treatment versus task-induced values observed at study entry and greater than pre-/posttreatment changes seen in patients r and omized to the WLC . A similar pattern emerged with respect to NKCA over the intervention period , which was independent of the changes in NK cells . There were no differences between patients assigned to EEGP and WLC in HR , DBP and SBP responses as well as in changes in PWM- and PHA-induced lymphocyte proliferation in response to the speech task measured before and after the 3-month intervention period . Individual differences in pre-/posttreatment increases in emotional expression but not in psychological distress were significantly associated with smaller changes in the number and function of NK cells over the 3-month period . Conclusions : These
Output:
| The most frequently employed instrument was the Courtauld Emotional Control Scale . |
MS211486 | ***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: Pomegranate has been shown to prolong PSA doubling time in early prostate cancer , but no data from a placebo controlled trial has been published yet . The objective of this study was to prospect ively evaluate the impact of pomegranate juice in patients with prostate cancer . We conducted a phase IIb , double blinded , r and omized placebo controlled trial in patients with histologically confirmed prostate cancer . Only patients with a PSA value ≥ 5ng/ml were included . The subjects consumed 500 ml of pomegranate juice or 500 ml of placebo beverage every day for a 4 week period . Thereafter , all patients received 250 ml of the pomegranate juice daily for another 4 weeks . PSA values were taken at baseline , day 14 , 28 and on day 56 . The primary endpoint was the detection of a significant difference in PSA serum levels between the groups after one month of treatment . Pain scores and adherence to intervention were recorded using patient diaries . 102 patients were enrolled . The majority of patients had castration resistant prostate cancer ( 68 % ) . 98 received either pomegranate juice or placebo between October 2008 and May 2011 . Adherence to protocol was good , with 94 patients ( 96 % ) completing the first period and 87 patients ( 89 % ) completing both periods . No grade 3 or higher toxicities occurred within the study . No differences were detected between the two groups with regard to PSA kinetics and pain scores . Consumption of pomegranate juice as an adjunct intervention in men with advanced prostate cancer does not result in significant PSA declines compared to placebo BACKGROUND Findings from early observational studies have suggested that the intake of dietary fat might be a contributing factor in the etiology of prostate cancer . However , the results from more recent prospect i ve studies do not support this hypothesis , and the possible association between different food sources of fat and prostate cancer risk also remains unclear . OBJECTIVE The objectives were to assess whether intakes of dietary fat , subtypes of fat , and fat from animal products were associated with prostate cancer risk . DESIGN This was a multicenter prospect i ve study of 142,520 men in the European Prospect i ve Investigation into Cancer and Nutrition ( EPIC ) . Dietary fat intake was estimated with the use of country-specific vali date d food question naires . The association between dietary fat and risk of prostate cancer was assessed by using Cox regression , stratified by recruitment center and adjusted for height , weight , smoking , education , marital status , and energy intake . RESULTS After a median follow-up time of 8.7 y , prostate cancer was diagnosed in 2727 men . There was no significant association between dietary fat ( total , saturated , monounsaturated , and polyunsaturated fat and the ratio of polyunsaturated to saturated fat ) and risk of prostate cancer . The hazard ratio for prostate cancer for the highest versus the lowest quintile of total fat intake was 0.96 ( 95 % CI : 0.84 , 1.09 ; P for trend = 0.155 ) . There were no significant associations between prostate cancer risk and fat from red meat , dairy products , and fish . CONCLUSION The results from this large multicenter study suggest that there is no association between dietary fat and prostate cancer risk Plasma fatty acid composition reflects dietary fatty acids . Whether the total fat content of the diet alters the fatty acid composition of plasma phospholipid , cholesteryl ester , triacylglycerol and free fatty acids is unknown . To evaluate the effects of low versus high fat diets on plasma fatty acids , a 12-wk , r and omized , crossover , controlled feeding trial was conducted in healthy men and women with isoenergic low fat ( 20 % energy ) and high fat ( 45 % energy ) diets containing constant proportions of fatty acids . Ten subjects consumed one experimental diet for 28 d , their usual diet for 4 wk and the alternate experimental diet for 28 d. Endpoint measures of plasma fatty acids were determined at the end of each experimental period . The effects of the two diets were compared within subjects by analysis of variance . Plasma fatty acids ( % ) varied in response to total dietary fat with significantly greater total polyunsaturated fat , ( n-6 ) and 18:2(n-6 ) levels in phospholipids and cholesteryl esters after high fat dietary consumption . The low fat diet was associated with significantly greater total ( n-3 ) fatty acids , 20:5(n-3 ) and 22:6(n-3 ) levels in plasma phospholipid fatty acids and cholesteryl esters . Consumption of a low fat diet alters fatty acid patterns in a manner similar to that observed with feeding of ( n-3 ) long-chain fatty acids . This change is likely related to decreased competition for the enzymes of elongation and desaturation , with reduced total intake of 18:2(n-6 ) favoring elongation and desaturation of available ( n-3 ) fatty acids The threat of prostate cancer and the significant and often negative impact of its treatment underscore the importance of prevention . High- grade prostatic intraepithelial neoplasia ( HGPIN ) has been identified as a potential premalignant lesion marking an increased risk of prostate cancer and substantial evidence suggests that men with HGPIN are in need of prostate cancer prevention . In vitro , in vivo , epidemiologic , and clinical trial evidence that selenium supplementation protects against prostate cancer motivated the study we report here : a double-blind , r and omized , placebo-controlled trial of selenium 200 ( μg/d ) as selenomethionine in men with HGPIN . The primary endpoint was progression of HGPIN to prostate cancer over a 3-year period . This National Cancer Institute Intergroup trial was coordinated by the Southwest Oncology Group ( SWOG ) . Of 619 enrolled patients , 423 r and omized men with HGPIN ( 212 selenium and 211 placebo ) were eligible ( by central pathology review ) and included in the primary analysis . Three-year cancer rates were 36.6 % ( placebo ) versus 35.6 % ( selenium ; P = 0.73 , adjusted ) . The majority of patients who developed cancer on trial ( 70.8 % , selenium and 75.5 % , placebo ) had a Gleason score of 6 or less than 6 ; there were no differences in Gleason scores between the two arms . Subset analyses included the finding of a nonsignificantly reduced prostate cancer risk ( relative risk = 0.82 ; 95 % CI : 0.40–1.69 ) in selenium versus placebo patients in the lowest quartile of baseline plasma selenium level ( < 106 ng/mL ) . Overall , and in all other subsets defined by baseline blood selenium levels , selenium supplementation had no effect on prostate cancer risk . The 36 % prostate cancer rate in men with HGPIN indicates the association of this lesion with an elevated prostate cancer risk . Future study in this setting should focus on selenium-deficient population s and selenium pharmacogenetics . Cancer Prev Res ; 4(11 ) ; 1761–9 . © 2011 AACR Previous studies have associated higher milk intake with greater prostate cancer ( PCa ) incidence , but little data are available concerning milk types and the relation between milk intake and risk of fatal PCa . We investigated the association between intake of dairy products and the incidence and survival of PCa during a 28-y follow-up . We conducted a cohort study in the Physicians ' Health Study ( n = 21,660 ) and a survival analysis among the incident PCa cases ( n = 2806 ) . Information on dairy product consumption was collected at baseline . PCa cases and deaths ( n = 305 ) were confirmed during follow-up . The intake of total dairy products was associated with increased PCa incidence [ HR = 1.12 ( 95 % CI : 0.93 , 1.35 ) ; > 2.5 servings/d vs. ≤0.5 servings/d ] . Skim/low-fat milk intake was positively associated with risk of low- grade , early stage , and screen-detected cancers , whereas whole milk intake was associated only with fatal PCa [ HR = 1.49 ( 95 % CI : 0.97 , 2.28 ) ; ≥237 mL/d ( 1 serving/d ) vs. rarely consumed ] . In the survival analysis , whole milk intake remained associated with risk of progression to fatal disease after diagnosis [ HR = 2.17 ( 95 % CI : 1.34 , 3.51 ) ] . In this prospect i ve cohort , higher intake of skim/low-fat milk was associated with a greater risk of nonaggressive PCa . Most importantly , only whole milk was consistently associated with higher incidence of fatal PCa in the entire cohort and higher PCa-specific mortality among cases . These findings add further evidence to suggest the potential role of dairy products in the development and prognosis of PCa Purpose : Phytochemicals in plants may have cancer preventive benefits through antioxidation and via gene-nutrient interactions . We sought to determine the effects of pomegranate juice ( a major source of antioxidants ) consumption on prostate-specific antigen ( PSA ) progression in men with a rising PSA following primary therapy . Experimental Design : A phase II , Simon two-stage clinical trial for men with rising PSA after surgery or radiotherapy was conducted . Eligible patients had a detectable PSA > 0.2 and < 5 ng/mL and Gleason score ≤7 . Patients were treated with 8 ounces of pomegranate juice daily ( Wonderful variety , 570 mg total polyphenol gallic acid equivalents ) until disease progression . Clinical end points included safety and effect on serum PSA , serum-induced proliferation and apoptosis of LNCaP cells , serum lipid peroxidation , and serum nitric oxide levels . Results : The study was fully accrued after efficacy criteria were met . There were no serious adverse events reported and the treatment was well tolerated . Mean PSA doubling time significantly increased with treatment from a mean of 15 months at baseline to 54 months posttreatment ( P < 0.001 ) . In vitro assays comparing pretreatment and posttreatment patient serum on the growth of LNCaP showed a 12 % decrease in cell proliferation and a 17 % increase in apoptosis ( P = 0.0048 and 0.0004 , respectively ) , a 23 % increase in serum nitric oxide ( P = 0.0085 ) , and significant ( P < 0.02 ) reductions in oxidative state and sensitivity to oxidation of serum lipids after versus before pomegranate juice consumption . Conclusions : We report the first clinical trial of pomegranate juice in patients with prostate cancer . The statistically significant prolongation of PSA doubling time , coupled with corresponding laboratory effects on prostate cancer in vitro cell proliferation and apoptosis as well as oxidative stress , warrant further testing in a placebo-controlled study BACKGROUND Epidemiologic studies have suggested that vitamin E and beta-carotene may each influence the development of prostate cancer . In the Alpha-Tocopherol , Beta-Carotene Cancer Prevention Study , a controlled trial , we studied the effect of alpha-tocopherol ( a form of vitamin E ) and beta-carotene supplementation , separately or together , on prostate cancer in male smokers . METHODS A total of 29133 male smokers aged 50 - 69 years from southwestern Finl and were r and omly assigned to receive alpha-tocopherol ( 50 mg ) , beta-carotene ( 20 mg ) , both agents , or placebo daily for 5 - 8 years ( median , 6.1 years ) . The supplementation effects were estimated by a proportional hazards model , and two-sided P values were calculated . RESULTS We found 246 new cases of and 62 deaths from prostate cancer during the follow-up period . A 32 % decrease ( 95 % confidence interval [ CI ] = -47 % to -12 % ) in the incidence of prostate cancer was observed among the subjects receiving alpha-tocopherol ( n = 14564 ) compared with those not receiving it ( n = 14569 ) . The reduction was evident in clinical prostate cancer but not in latent cancer . Mortality from prostate cancer was 41 % lower ( 95 % CI = -65 % to -1 % ) among men receiving alpha-tocopherol . Among subjects receiving beta-carotene ( n = 14560 ) , prostate cancer incidence was 23 % higher ( 95 % CI = -4%-59 % ) and mortality was 15 % higher ( 95 % CI = -30%-89 % ) compared with those not receiving it ( n = 14573 ) . Neither agent had any effect on the time interval between diagnosis and death . CONCLUSIONS Long-term supplementation with alpha-tocopherol substantially reduced prostate cancer incidence and mortality in male smokers . Other controlled trials are required to confirm the findings CONTEXT Secondary analyses of 2 r and omized controlled trials and supportive epidemiologic and pre clinical data indicated the potential of selenium and vitamin E for preventing prostate cancer . OBJECTIVE To determine whether selenium , vitamin E , or both could prevent prostate cancer and other diseases with little or no toxicity in relatively healthy men . DESIGN , SETTING , AND PARTICIPANTS A r and omized , placebo-controlled trial ( Selenium and Vitamin E Cancer Prevention Trial [ SELECT ] ) of 35
Output:
| Results Red meat , dietary fat and milk intake should be minimised as they appear to increase the risk of prostate cancer .
Selenium and vitamin supplements can not be advocated for the prevention of prostate cancer and indeed higher doses may be associated with a worse prognosis .
There is no specific evidence regarding benefits of probiotics or prebiotics in prostate cancer . |
MS211487 | ***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 effect of hydroxychloroquine ( HCQ ) on dry eye has not been fully determined . This study aim ed to compare the 12-week efficacy of HCQ medication with that of a placebo in the management of dry eye in primary Sjögren 's syndrome ( pSS ) . A double-blind , r and omized control study was conducted in 39 pSS subjects from May 2011 through August 2013 . pSS was diagnosed based on the classification criteria of the American-European Consensus Group . Subjects received 300 mg of HCQ or placebo once daily for 12 weeks and were evaluated at baseline , 6 , and 12 weeks , with a re-visit at 16 weeks after drug discontinuance . The fluorescein staining score , Schirmer test score , tear film break-up time ( TBUT ) , and ocular surface disease index ( OSDI ) were measured , and tears and blood were collected for ESR , IL-6 , IL-17 , B-cell activating factor ( BAFF ) , and Th17 cell analysis . Color testing was performed and the fundus was examined to monitor HCQ complications . Twenty-six subjects completed the follow-up . The fluorescein staining score and Schirmer test score did not differ significantly . The OSDI improved with medication in the HCQ group but was not significantly different between the groups . TBUT , serum IL-6 , ESR , serum and tear BAFF , and the proportion of Th17 cells did not change in either group . HCQ at 300 mg daily for 12 weeks has no apparent clinical benefit for dry eye and systemic inflammation in pSS ( Clinical Trials.gov . NCT01601028 ) OBJECTIVE To define the clinical manifestations , autoantibody associations , optimal treatment , and prognosis of hypergammaglobulinemic purpura associated with systemic autoimmune rheumatic diseases . METHODS Of 303 consecutive patients with systemic autoimmune rheumatic diseases evaluated over 5 years , 17 French Canadian patients with hypergammaglobulinemic purpura with systemic lupus erythematosus ( SLE ) ( n = 12 ) or another systemic autoimmune rheumatic disease ( n = 5 ) were identified and followed prospect ively . Mild secondary Sjörgren 's syndrome developed in 9 ( 53 % ) patients . RESULTS Sixteen ( 94.1 % ) patients were women . Attacks of hypergammaglobulinemic purpura occurred in the pretibial ( 76.5 % ) or perimalleolar ( 70.5 % ) areas or the dorsal aspect of the feet ( 52.9 % ) . Triggering factors included walking , prolonged st and ing , and alcohol intake . The mean duration of attacks was 6.1 days . Systemic manifestations consistent with a flare of the underlying systemic autoimmune rheumatic diseases accompanied hypergammaglobulinemic purpura attacks in 15 ( 88 % ) patients . Arthralgias ( n = 13 , 86.6 % ) , arthritis ( n = 9 , 69.2 % ) , and periarthritis were characterstically localized adjacent to the purpura . Anti-Ro antibodies were expressed in all ( 100 % ) patients with hypergammaglobulinemic purpura with SLE , but in only 11 ( 28.9 % ) of 38 consecutive patients with SLE without hypergammaglobulinemic purpura ( P < 0.000001 , odds ratio 84 , 95 % confidence interval 4.6 , 1525 ) . The positive predictive values for hypergammaglobulinemic purpura in SLE were : anti-Ro plus anti-La 73 % , anti-La 57 % , and anti-Ro 52 % . The negative predictive value of anti-Ro was 100 % . Although 11 ( 92 % ) patients with SLE with anti-Ro expressed anti-52 kDa Ro [ 4 ( 36.3 % ) of whom also expressed anti-60 kDa Ro ] , this frequency was not greater than in anti-Ro positive patients with SLE without hypergammaglobulinemic purpura . The effects of indomethacin or hydroxychloroquine were assessed over 6 months in 8 patients with recurrent incapacitating hypergammaglobulinemic purpura . Complete ( n = 4 ) or partial ( n = 4 ) remission of hypergammaglobulinemic purpura occurred . In 5 additional patients with severe hypergammaglobulinemic purpura , attacks stopped with prednisone 25 to 60 mg daily . The mean duration of hypergammaglobulinemic purpura followup was 5.4 years ( range 1 - 6 years ) . At last followup , hypergammaglobulinemic purpura had resolved in 11 ( 64.7 % ) patients despite persistently abnormal serology . CONCLUSION In the absence of anti-Ro antibodies , a presumptive diagnosis of hypergammaglobulinemic purpura secondary to SLE should be question ed . Prednisone should be used only in severe hypergammaglobulinemic purpura . Indomethacin and hydroxychloroquine are of value in the treatment of milder hypergammaglobulinemic purpura Objectives To analyze the clinical and immunological characteristics at enrollment in a large prospect i ve cohort of patients with primary Sjögren 's syndrome ( pSS ) and to investigate the association between serum BAFF , beta2-microglobulin and free light chains of immunoglobulins and systemic disease activity at enrollment . Methods Three hundred and ninety five patients with pSS according to American-European Consensus Criteria were included from fifteen centers of Rheumatology and Internal Medicine in the “ Assessment of Systemic Signs and Evolution of Sjögren 's Syndrome ” ( ASSESS ) 5-year prospect i ve cohort . At enrollment , serum markers were assessed as well as activity of the disease measured with the EULAR Sjögren 's Syndrome Disease Activity Index ( ESSDAI ) . Results Patient median age was 58 ( 25th–75th : 51–67 ) and median disease duration was 5 ( 2–9 ) years . Median ESSDAI at enrollment was 2 ( 0–7 ) with 30.9 % of patients having features of systemic involvement . Patients with elevated BAFF , beta2-microglobulin and kappa , lambda FLCS had higher ESSDAI scores at enrollment ( 4 [2]–[11 ] vs 2 [ 0–7 ] , P = 0.03 ; 4 [1]–[11 ] vs 2 [ 0–7 ] , P < 0.0001 ) ; 4 [2]–[10 ] vs 2 [ 0–6.6 ] , P < 0.0001 and 4 [ 2–8.2 ] vs 2 [ 0–7.0 ] , P = 0.02 , respectively ) . In multivariate analysis , increased beta2-microglobulin , kappa and lambda FLCs were associated with a higher ESSDAI score . Median BAFF and beta2-microglobulin were higher in the 16 patients with history of lymphoma ( 1173.3(873.1–3665.5 ) vs 898.9 ( 715.9–1187.2 ) pg/ml , P = 0.01 and 2.6 ( 2.2–2.9 ) vs 2.1 ( 1.8–2.6 ) mg/l , P = 0.04 , respectively ) . Conclusion In pSS , higher levels of beta2-microglobulin and free light chains of immunoglobulins are associated with increased systemic disease activity OBJECTIVES --In 1985 and 1988 a positive effect of treatment of primary Sjögren 's syndrome with hydroxychloroquine was reported in two small open studies . To investigate further the clinical and laboratory effects of hydroxychloroquine in primary Sjögren 's syndrome a two year study was performed . METHODS --The design of the study included a prospect i ve , placebo controlled , two year double blind crossover trial in 19 patients . RESULTS --A significant decrease in IgG and IgM and a tendency for a decrease in the erythrocyte sedimentation rate ( ESR ) during treatment with hydroxychloroquine compared with treatment with placebo were found . No beneficial clinical effect of the use of hydroxychloroquine as expressed in preference for treatment with hydroxychloroquine or placebo with regard to symptoms and signs of primary Sjögren 's syndrome could be shown , however , nor any relevant change in tear gl and activity and sequelae of peripheral tear function deficiency , nor salivary gl and scintigraphy . CONCLUSIONS --The use of hydroxychloroquine at a dose of 400 mg daily taken over a 12 month period does not have a worthwhile clinical benefit in patients with primary Sjögren 's syndrome despite an improvement of hyperglobulinaemia and slight changes in the ESR and The dysregulated cytokine network in Sjögren 's Syndrome ( SS ) is reflected by local and systemic overexpression of pro-inflammatory cytokines and absent or low levels of anti-inflammatory cytokines . To date , the use of cytokine based therapies in SS has been disappointing . Oral administration of low dose interferon ( IFN ) α showed inconsistent efficacy in various studies and failed to achieve the primary endpoint in a pivotal r and omised controlled trial . Similarly , neither of the two tumour necrosis factor (TNF)-α blockers tested ( etanercept and infliximab ) showed efficacy in placebo controlled trials . Although the rationale for low dose oral IFN treatment has not been firmly established , TNF blockade was based on solid pre clinical data . Therefore , the reason for the lack of efficacy is unclear , but recent data suggest that unexpected biological effects of TNF antagonists may have contributed to this . Cytokines , given their central role in the pathogenesis of SS , remain attractive targets for future treatments , despite the disappointing early results . Inflammatory cytokines are obvious c and i date s , and agents against several of them are available or under development for other autoimmune diseases similar to SS . New c and i date cytokines such as IL-17 and IL-12 and /or IL-23 may provide promising targets for SS . Additionally , as an alternative to systemic treatment , which has the risk of potentially severe side effects , the use of local cytokine directed therapy should be explored OBJECTIVE To evaluate the effect of hydroxychloroquine treatment on interleukin 6 ( IL6 ) , hyaluronic acid ( HA ) , and soluble interleukin 2 receptor ( sIL2R ) concentrations in the saliva and serum of patients with primary Sjögren ’s syndrome ( SS ) . METHODS Fourteen SS patients treated with hydroxychloroquine 200 mg/day for 12 months were investigated in an open prospect i ve study . Clinical parameters of efficacy and routine biochemical and haematological data to assess drug safety and tolerability were determined every three months . Salivary and serum IL6 , sIL2R , and HA values were determined at study entry , 6 and 12 months , using ELISA and radiometric assays . RESULTS After hydroxychloroquine treatment , salivary IL6 concentrations decreased from 13.2 ( 1.2 ) to 7.3 ( 1.1 ) pg/ml ( mean ( SEM ) ) ( p < 0.0001 ) . Similarly , salivary HA concentrations were also reduced from 577.8 ( 120 ) to 200 ( 34 ) ng/ml ( mean ( SEM ) ( p < 0.003 ) . Serum IL6 concentrations decreased from 5.4 ( 0.6 ) to 2.9 ( 0.2 ) pg/ml ( mean ( SEM ) ( p < 0.001 ) , while serum HA concentrations remained unchanged . No change has been detected in salivary or serum sIL2R concentrations after 12 months of treatment with hydroxychloroquine . Treatment also result ed in significant reduction in erythrocyte sedimentation rate , serum γ globulin , and C reactive protein values while only partial clinical improvement was noted in some patients . A more pronounced decrease of salivary IL6 and HA levels was found in the two patients in whom a reduction in the swelling of the parotid gl and was noted . CONCLUSION In this open label study of hydroxychloroquine treatment for SS a significant reduction of some salivary inflammatory markers was seen at the end of 12 months . Although during the treatment period only a partial clinical effect could be noted , the findings suggest that a double blind controlled study of hydroxychloroquine in SS is indicated 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
Output:
| For dry mouth and dry eyes , the effectiveness of HCQ treatment was essentially the same as placebo treatment .
For fatigue , the effectiveness of HCQ was lower than placebo .
The efficacy of HCQ in treating pain associated with pSS was superior to that of the placebo .
There was no significant difference between HCQ-treated groups and controls in terms of Schirmer test results , but HCQ could reduce the erythrocyte sedimentation rate compare with placebo .
A descriptive safety assessment showed that gastrointestinal adverse effects were the most common adverse effects associated with HCQ .
Conclusions This systematic review showed that there is no significant difference between HCQ and placebo in the treatment of dry mouth and dry eye in pSS . |
MS211488 | ***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: & NA ; A multicenter , prospect i ve study ( n = 103 ) examined the psychological implication s of women 's decisions for or against breast reconstruction . Recognized measures of anxiety , depression , body image , and quality of life were completed before the operation , and 6 and 12 months later . A reduction in psychological distress over the year following the operation was evident in each surgical group ( mastectomy alone or immediate or delayed reconstruction ) . indicating that reconstructive surgery can offer psychological benefits to some women : however , others report improved psychological functioning without this surgical procedure . In contrast to existing retrospective research , the prospect i ve design enabled the process of adjustment during the first year after the operation to be examined . The results indicate that breast reconstruction is not a universal panacea for the emotional and psychological consequences of mastectomy . Women still reported feeling conscious of altered body image 1 year postoperatively , regardless of whether or not they had elected breast reconstruction . Health professionals should be careful of assuming that breast reconstruction necessarily confers psychological benefits compared with mastectomy alone As weil as the medical outcomes of two distinct operations , namely total mastectomy and breast-conserving therapy , their impact on the psychic structureing of the patient may differ . A group of 40 woman with who had undergone mastectomy were therefore compared with another 40 with who had received breast-conserving therapy , with regard to the variables of body image , self-esteem and social support . The women who underwent breast-conserving therapy had a more positive body image ( P<0.001 ) . The two groups showed a negligble difference with respect to self-esteem and social support ( P>0.05 ) . A negative correlation was found between body image and social support ( P<0.05 ) . Patients with total mastectomy therefore do have a more negative body image than patients receiving breast-conserving therapy . Self-esteem and social support in the postoperative period in two groups are comparable BACKGROUND During the last decade , survival rates for breast cancer have increased as a result of earlier detection and increased use of adjuvant therapy . Limited data exist on the psychosocial aspects of the transitional period between the end of primary treatment and survivorship . We investigated the baseline psychosocial status of women enrolled in a r and omized trial testing two psychosocial interventions for women at the end of primary treatment . METHODS Participants , identified within 1 month after surgery ( registration ) , provided demographic information and limited measures of quality of life . They were followed until they finished primary treatment ( enrollment ) , at which time they completed a mailed baseline survey that included st and ardized measures of quality of life ( including st and ardized scales of physical and emotional functioning ) , mood , symptoms , and sexual functioning . A total of 558 patients ( mean age = 56.9 years ) were enrolled in the study between July 1 , 1999 , and June 30 , 2002 . Health outcomes were examined according to treatment received : mastectomy with and without chemotherapy , and lumpectomy with and without chemotherapy . All statistical tests were two-sided . RESULTS Among all treatment groups , patients who had a mastectomy had the poorest physical functioning at registration ( P<.001 ) and at enrollment ( P=.05 ) . At enrollment , mood and emotional functioning were similar among all patients , with no differences by type of treatment received . At enrollment , symptoms , including muscle stiffness , breast sensitivity , aches and pains , tendency to take naps , and difficulty concentrating , were common among patients in all groups and were statistically significantly associated with poor physical functioning and emotional well-being . Sexual functioning was worse for women who received chemotherapy than for those who did not , regardless of type of surgery ( P<.001 ) . CONCLUSIONS At the end of primary treatment for breast cancer , women in all treatment groups report good emotional functioning but report decreased physical functioning , particularly among women who have a mastectomy or receive chemotherapy . Clinical interventions to address common symptoms associated with treatment should be considered to improve physical and emotional functioning at the end of primary treatment for breast cancer In the past decade , changing attitudes toward breast reconstruction among both patients and providers have led a growing number of women to seek breast reconstruction after mastectomy . Although investigators have documented the psychological , social , emotional , and functional benefits of breast reconstruction , little research has evaluated the effects of procedure choice on these outcomes . The current study prospect ively evaluated and compared psychosocial outcomes for three common options for mastectomy reconstruction : tissue exp and er/implant , pedicle TRAM , and free TRAM techniques . In a prospect i ve cohort design , patients undergoing postmastectomy reconstruction for the first time with exp and er/implant , pedicle TRAM , or free TRAM procedures were recruited from 12 centers and 23 plastic surgeons in the United States and Canada . Before reconstruction and at 1 year after reconstruction , patients were evaluated by a battery of question naires consisting of both generic and condition-specific surveys . Outcomes assessed included emotional well-being , vitality , general mental health , social functioning , functional well-being , social well-being , and body image . Baseline ( preoperative ) scores and the change in scores ( the difference between postoperative and preoperative scores ) were compared across procedure types using t tests and analysis of covariance . Preoperative and 1-year postoperative surveys were obtained from 273 patients . Procedure type was reported in 250 patients , of whom 56 received implant reconstructions , 128 pedicle TRAM flaps , and 66 free TRAM flaps . A total of 161 immediate and 89 delayed reconstructions were performed . Among women receiving immediate reconstruction , significant improvements were observed in all psychosocial variables except body image . However , no significant effects of procedure type on these changes over time existed . Similarly , delayed reconstruction patients had significant increases in emotional well-being , vitality , general mental health , functional well-being , and body image . Although the choice of reconstructive technique did not significantly impact most of these outcomes , significant differences existed among procedure types for three psychosocial subscales . Patients undergoing delayed exp and er/implant reconstructions reported greater improvements in vitality and social well-being relative to women receiving delayed TRAM procedures . By contrast , delayed TRAM patients noted significantly greater gains in body image compared with women choosing delayed exp and er-implant reconstruction . The authors conclude that both immediate and delayed breast reconstructions provide substantial psychosocial benefits for mastectomy patients . Although the choice of reconstructive procedure does not seem to significantly affect improvements in psychosocial status with immediate reconstruction , our data suggest that procedure type does have a significant effect on gains in vitality and body image for women undergoing delayed reconstruction Purpose To compare the quality -of-life ( QoL ) and psycho-social changes in a group of patients with early breast cancer who underwent conservative surgery ( BCS ) or modified radical mastectomy ( MRM ) . Methods Self-administered question naire assessing body image perception , social habits , sexual attraction and self-consciousness with relatives/friends , was r and omly assigned to 125 patients ( 61 BCS , 64 MRM ; aged 53±8 and 50±9 years , respectively , p = NS ) . Results MRM patients reported a significantly higher frequency of changes in body image perception and other related social behaviour such as avoiding going to the beach or using low-cut clothes , and reticence with friends . Conversely , no differences were found regarding sexuality , denial of the disease by the husb and /partner , or concealing the disease from family members . Also , no significant differences were found between patients above and below the age of 50 years , for all variables studied after adjustment for surgical procedure . Conclusions Modified radical mastectomy has a negative effect on body image perception and in social behaviour patterns of patients and with a concomitant decrease in QoL. The sexuality of the patient is not significantly affected Background The various surgical procedures for early-stage breast cancer are equivalent in terms of survival . Therefore , other factors , such as the procedures ’ effect on psychosocial adjustment and quality of life ( QOL ) , take on great importance . The aim of the current study was to prospect ively examine the short- and long-term effects of mastectomy with reconstruction , mastectomy without reconstruction , and breast conservation therapy on aspects of psychosocial adjustment and QOL in a sample of 258 women with breast cancer . Methods Participants completed question naires before surgery and then again 1 , 6 , 12 , and 24 months after surgery . Question naires assessed depressive symptoms , anxiety , body image , sexual functioning , and QOL . Results Adjustment patterns differed throughout the 2-year period after surgery . Some short-term changes in adjustment ( less anxiety , less overall body satisfaction ) were similar across surgery groups , whereas others ( satisfaction with chest appearance , QOL in physical health domain ) were higher for women who had breast conservation therapy . However , women who had mastectomy with reconstruction reported greater satisfaction with their abdominal area . During the long-term follow-up period ( 6 months to 2 years after surgery ) , women in all three groups experienced marked improvements in psychosocial adjustment ( depressive symptoms , satisfaction with chest appearance , sexual functioning ) and QOL in physical and mental health domains . In fact , the level for most variables returned to baseline levels or higher . Conclusions Overall , the general patterns of psychosocial adjustment and QOL are similar among the three surgery groups Psychiatric disorders such as depression and anxiety are common among cancer patients . If left untreated , these disorders can lead to poor treatment compliance , prolonged hospital stay and reduced life quality . In this prospect i ve study , we aim ed determine anxiety and depression levels and related factors among female breast cancer patients presenting to a breast surgery clinic in Istanbul and who met the inclusion criteria . Data were collected using a question naire and the Hospital Anxiety and Depression Scale ( HAD ) . The mean age was 48.2 years and the mean post-operative period was 17.9 months . It was found that 46.3 % of the patients had stage I , and 53.7 % stage II , 59.3 % of them undergoing breast conserving surgery and 40.7 % mastectomy . When evaluated according to the HAD Scale , it was found that anxiety scores of 35.1 % of the patients and depression scores of 17.1 % of the patients were higher than their cut-off points . With regard to the affecting factors , depression scores of those with no family history of breast cancer were significantly higher than those with no family history of breast cancer ( t= 1.53 ; p= 0.03 ) ; that the depression scores of the patients who underwent mastectomy were significantly higher than those who underwent breast conserving surgery ( t= 1.75 ; p= 0.04 ) . Additionally , it was found that low income was an important risk factor for anxiety ; whereas a history of breast cancer in the family and mastectomy was an important risk factor for depression . These results indicate the importance of determining psychiatric problems and appropriate approaches in addition to medical treatment in breast cancer patients BACKGROUND In 1976 , we initiated a r and omized trial to determine whether lumpectomy with or without radiation therapy was as effective as total mastectomy for the treatment of invasive breast cancer . METHODS A total of 1851 women for whom follow-up data were available and nodal status was known underwent r and omly assigned treatment consisting of total mastectomy , lumpectomy alone , or lumpectomy and breast irradiation . Kaplan-Meier and cumulative-incidence estimates of the outcome were obtained . RESULTS The cumulative incidence of recurrent tumor in the ipsilateral breast was 14.3 percent in the women who underwent lumpectomy and breast irradiation , as compared with 39.2 percent in the women who underwent lumpectomy without irradiation ( P<0.001 ) . No significant differences were observed among the three groups of women with respect to disease-free survival , distant-disease-free survival , or overall survival . The hazard ratio for death among the women who underwent lumpectomy alone , as compared with those who underwent total mastectomy , was 1.05 ( 95 percent confidence interval , 0.90 to 1.23 ; P=0.51 ) . The hazard ratio for death among the women who underwent lumpectomy followed by breast irradiation , as compared with those who underwent total mastectomy , was 0.97 ( 95 percent confidence interval , 0.83 to 1.14 ; P=0.74 ) . Among the lumpectomy-treated women whose surgical specimens had tumor-free margins , the hazard ratio for death among the women who underwent postoperative breast irradiation , as compared with those who did not , was 0.91 ( 95 percent confidence interval , 0.77 to 1.06 ; P=0.23 ) . Radiation therapy was associated with a marginally significant decrease in deaths due to breast cancer . This decrease was partially offset by an increase in deaths from other causes . CONCLUSIONS Lumpectomy followed by breast irradiation continues to be appropriate therapy for women with breast cancer , provided that the margins of resected specimens are free of tumor and an acceptable cosmetic result can be obtained BACKGROUND Depression is common in breast cancer patients . The aim of this paper was to make a systematic review of its prevalence and associated factors oin breast cancer survivors . MATERIAL S AND METHODS An extensive systematic electronic review ( PUBMED , CINAHL , PsyINFO and Ovid ) and h and search were carried out to retrieve published articles up to November 2012 , using Depression OR Dysthymia AND ( Cancer OR Tumor OR Neoplasms as the keywords . Information about the design of the studies , measuring scale , characteristics of the participants , prevalence of depression and its associated factors from the included studies were extracted and summarized . RESULTS We identified 32 eligible studies that recruited 10,826 breast cancer survivors . Most were cross-sectional or prospect i ve design ed . The most frequent instrument used to screen depression was the Center for Epidemiological Studies for Depression
Output:
| Conclusions Our study showed that there were no statistically significant differences concerning the occurrence of depressive symptoms in breast cancer patients as a consequence of TM , BCS or BR at mean time more than 1-year term postoperatively |
MS211489 | ***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 This in vitro study was performed to correlate the presence of discoloration on occlusal surfaces with its histological depth and assess its influence on Diagnodent measurements in a group of permanent and primary teeth . METHODS Ninty-five primary and 95 permanent third molars were r and omly selected from a pool of macroscopically intact teeth . One site of the fissure on each occlusal surface was selected and categorized according to its discoloration . Each site was measured 3 times with Diagnodent . The teeth were prepared histologically and evaluated according to their caries extent under a microscope ( final magnification x 12.8 ) . RESULTS In the group of permanent teeth with dark brown or black discoloration ( N=23 ) , 13 % showed dentinal caries , 57 % were sound or had an initial enamel lesion , and 30 % had a deep enamel lesion . In the group of primary teeth with dark brown and black discoloration ( N=19 ) , 42 % presented dentinal caries , 42 % showed deep enamel caries , and 16 % had an initial enamel lesion . The difference between permanent and primary teeth was statistically significant ( P<.05 ) . Discolored fissures showed higher Diagnodent values than nondiscolored or opaque fissures in both groups ( independent of their caries status ) . CONCLUSIONS The presence of brown or dark spots on fissures were not useful for the prediction of dentinal caries for permanent teeth . In primary teeth , however , a higher correlation between fissure discoloration and dentinal lesions was found . Diagnodent tends to overscore discolored surfaces Diagnosis is a critical component of health care , and clinicians , policymakers , and patients routinely face a range of questions regarding diagnostic tests . They want to know whether testing improves outcome ; what test to use , purchase , or recommend in practice guidelines ; and how to interpret test results . Well- design ed diagnostic test accuracy studies can help in making these decisions , provided that they transparently and fully report their participants , tests , methods , and results as facilitated , for example , by the STARD ( St and ards for Reporting of Diagnostic Accuracy ) statement ( 1 ) . That 25-item checklist was published in many journals and is now adopted by more than 200 scientific journals worldwide . As in other areas of science , systematic review s and meta- analysis of accuracy studies can be used to obtain more precise estimates when small studies addressing the same test and patients in the same setting are available . Review s can also be useful to establish whether and how scientific findings vary by particular subgroups , and may provide summary estimates with a stronger generalizability than estimates from a single study . Systematic review s may help identify the risk for bias that may be present in the original studies and can be used to address questions that were not directly considered in the primary studies , such as comparisons between tests . The Cochrane Collaboration is the largest international organization preparing , maintaining , and promoting systematic review s to help people make well-informed decisions about health care ( 2 ) . The Collaboration decided in 2003 to make preparations for including systematic review s of diagnostic test accuracy in their Cochrane Data base of Systematic Review s. To enable this , a working group ( Appendix ) . was formed to develop methodology , software , and a h and book The first diagnostic test accuracy review was published in the Cochrane Data base in October 2008 . In this paper , we review recent method ological developments concerning problem formulation , location of literature , quality assessment , and meta- analysis of diagnostic accuracy studies by using our experience from the work on the Cochrane H and book . The information presented here is based on the recent literature and up date s previously published guidelines by Irwig and colleagues ( 3 ) . Definition of the Objectives of the Review Diagnostic test accuracy refers to the ability of a test to distinguish between patients with disease ( or more generally , a specified target condition ) and those without . In a study of test accuracy , the results of the test under evaluation , the index test , are compared with those of the reference st and ard determined in the same patients . The reference st and ard is an agreed-on and accurate method for identifying patients who have the target condition . Test results are typically categorized as positive or negative for the target condition . By using such binary test outcomes , the accuracy is most often expressed as the test 's sensitivity ( the proportion of patients with positive results on the reference st and ard that are also positive on the index test ) and specificity ( the proportion of patients with negative results on the reference st and ard that are also negative on the index test ) . Other measures have been proposed and are in use ( 46 ) . It has long been recognized that test accuracy is not a fixed property of a test . It can vary between patient subgroups , with their spectrum of disease , with the clinical setting , or with the test interpreters and may depend on the results of previous testing . For this reason , inclusion of these elements in the study question is essential . In order to make a policy decision to promote use of a new index test , evidence is required that using the new test increases test accuracy over other testing options , including current practice , or that the new test has equivalent accuracy but offers other advantages ( 79 ) . As with the evaluation of interventions , systematic review s need to include comparative analyses between alternative testing strategies and should not focus solely on evaluating the performance of a test in isolation . In relation to the existing situation , 3 possible roles for a new test can be defined : replacement , triage , and add-on ( 7 ) . If a new test is to replace an existing test , then comparing the accuracy of both tests on the same population and with the same reference st and ard provides the most direct evidence . In triage , the new test is used before the existing test or testing pathway , and only patients with a particular result on the triage test continue the testing pathway . When a test is needed to rule out disease in patients who then need no further testing , a test that gives a minimal proportion of falsenegative results and thus a relatively high sensitivity should be used . Triage tests may be less accurate than existing ones , but they have other advantages , such as simplicity or low cost . A third possible role of a new test is add-on . The new test is then positioned after the existing testing pathway to identify false-positive or false-negative results after the existing pathway . The review should provide data to assess the incremental change in accuracy made by adding the new test . An example of a replacement question can be found in a systematic review of the diagnostic accuracy of urinary markers for primary bladder cancer ( 10 ) . Clinicians may use cytology to triage patients before they undergo invasive cystoscopy , the reference st and ard for bladder cancer . Because cytology combines high specificity with low sensitivity ( 11 ) , the goal of the review was to identify a tumor marker with sufficient accuracy to either replace cytology or be used in addition to cytology . For a marker to replace cytology , it has to achieve equally high specificity with improved sensitivity . New markers that are sensitive but not specific may have roles as adjuncts to conventional testing . The review included studies in which the test under evaluation ( several different tumor markers and cytology ) was evaluated against cystoscopy or histopathology . Included studies compared 1 or more of the markers , cytology only , or a combination of markers and cytology . Although information on accuracy can help clinicians make decisions about tests , good diagnostic accuracy is a desirable but not sufficient condition for the effectiveness of a test ( 8) . To demonstrate that using a new test does more good than harm to patients tested , r and omized trials of test- and -treatment strategies and review s of such trials may be necessary . However , with the possible exception of screening , in most cases , such r and omized trials are not available and systematic review s of test accuracy may provide the most useful evidence available to guide clinical and health policy decision making and use as input for decision and cost-effectiveness analysis ( 12 ) . Identification and Selection of Studies Identifying test accuracy studies is more difficult than search ing for r and omized trials ( 13 ) . There is not a clear , unequivocal keyword or indexing term for an accuracy study in literature data bases comparable with the term r and omized , controlled trial . The Medical Subject Heading sensitivity and specificity may look suitable but is inconsistently applied in most electronic bibliographic data bases . Furthermore , data on diagnostic test accuracy may be hidden in studies that did not have test accuracy estimation as their primary objective . This complicates the efficient identification of diagnostic test accuracy studies in electronic data bases , such as MEDLINE . Until indexing systems properly code studies of test accuracy , search ing for them will remain challenging and may require additional manual search es , such as screening reference lists . In the development of a comprehensive search strategy , review authors can use search strings that refer to the test(s ) under evaluation , the target condition , and the patient description or a subset of these . For tests with a clear name that are used for a single purpose , search ing for publications in which those tests are mentioned may suffice . For other review s , adding the patient description may be necessary , although this is also often poorly indexed . A search strategy in MEDLINE should contain both Medical Subject Headings and free text words . A search strategy for articles about tests for bladder cancer , for example , should include as many synonyms for bladder cancer as possible in the search strategy , including neoplasm , carcinoma , transitional cell , and hematuria . Several method ological electronic search filters for diagnostic test accuracy studies have been developed , each attempting to restrict the search to articles that are most likely to be test accuracy studies ( 1316 ) . These filters rely on indexing terms for research methodology and text words used in reporting results , but they often miss relevant studies and are unlikely to decrease the number of articles one needs to screen . Therefore , they are not recommended for systematic review s ( 17 , 18 ) . The incremental value of search ing in language s other than English and in the gray literature has not yet been fully investigated . In systematic review s of intervention studies , publication bias is an important and well-studied form of bias in which the decision to report and publish studies is linked to their findings . For clinical trials , the magnitude and determinants of publication bias have been identified by tracing the publication history of cohorts of trials review ed by ethics committees and research boards ( 19 ) . A consistent observation has been that studies with significant results are more likely to be published than studies with nonsignificant findings ( 19 ) . Investigating publication bias for diagnostic tests is problematic , because many studies are done without ethical review or study registration ; therefore , identification of cohorts of studies from registration to final publication status OBJECTIVE The objective of this study was to assess trends in dental caries prevalence and severity in 1- to 4 year-old children living in Diadema , Brazil , over a 11-year period , from 1997 to 2008 . METHODS In 2008 an epidemiological oral health survey was carried out and the results on caries were compared with five cross-sectional studies carried out using the same methods and criteria in 1997 , 1999 , 2002 , 2004 , and 2006 in the same city . In all surveys , children were r and omly selected from those attending a National Day of Children 's Vaccination . Calibrated dentists carried out the clinical examination using WHO criteria . Caries trends were assessed by time-lag analysis . In total , 5348 children were examined in the six surveys over the 11-year period . RESULTS Time-lag analysis showed a marked and statistically significant decline in the prevalence ( chi(2 ) for trends : P < 0.001 ) and severity ( Kruskal-Wallis : P < 0.001 ) of dental caries between 1997 and 2008 . CONCLUSION In conclusion , the last cohort of preschool children in Diadema had much better dental caries status than those in 1997 The aim of this in vitro study was to investigate the intra- and interdevice reproducibility of the DIAGNOdent 2095 ( DD2095 ) and the new DIAGNOdent Pen ( DDPen ) on non-cavitated occlusal caries sites . Altogether , 241 sites on 90 molars were inspected twice with both devices and by four examiners . The intra/interdevice reproducibilities were assessed by means of the intraclass correlation coefficient ( ICC ) as well as by the range of the 95 % limits of agreement of Bl and & Altman . Additionally , a linear mixed-effects model was fitted with fixed effects for the visual scores and the devices used and r and om effects for occlusal sites and examiners within each measurement site . In result , the following values were determined for the intradevice reproducibility : DD2095 : ICC 0.89 , range 42.3 ; and DDPen : ICC 0.88 , range 49.3 . The interdevice reproducibility was found to be in the same order of magnitude ( ICC 0.82 , range 53.7 ) . The comparison between both devices indicated significantly lower mean values for the DDPen . The estimates of the linear model show that there is a high variation between the sites that can not be explained by the fixed effects . In conclusion , both devices showed an imperfect reproducibility , which indicate the usage as adjunct tool only in clinical practice Children and adolescents must be examined often for occlusal caries . Diagnosis of fissure caries is difficult especially when the tooth surface appears seemingly intact . It has been shown that using traditional clinical methods , as little as 20 % of teeth with fissure caries under intact surfaces were correctly recognised as such . Therefore , new methods for increasing the accuracy of diagnosis have been sought for years . Recently , a new device , based on fluorescence measurements , was introduced . The purpose of this study was to test the device under in vivo conditions in order to provide recommendations for its use in the dental office . Seven general dental practitioners examined a total of 332 occlusal surfaces in 240 patients . Caries extent was determined for each site after operative intervention ( = ' gold st and ard ' ) . Clinical inspection and analysis of bitewing radiographs exhibited statistically significant lower sensitivities ( 31 - 63 % ) than did the DIAGNOdent device ( sensitivity > or = 92 % ) . It is recommended that the laser device is used in the decision-making process in relation to the diagnosis of occlusal caries as a second opinion in cases of doubt after visual inspection
Output:
| In general , the analysis demonstrated that the fluorescence-based method tend to have similar accuracy for all types of teeth , dental surfaces or setting s. There was a trend of better performance of fluorescence methods in detecting more advanced caries lesions .
CONCLUSIONS Fluorescence-based devices have similar overall performance ; however , better accuracy in detecting more advanced caries lesions has been observed |
MS211490 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
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Input: OBJECTIVE To determine the effectiveness of brief strategic family therapy ( BSFT ; an evidence -based family therapy ) compared to treatment as usual ( TAU ) as provided in community-based adolescent outpatient drug abuse programs . METHOD A r and omized effectiveness trial in the National Drug Abuse Treatment Clinical Trials Network compared BSFT to TAU with a multiethnic sample of adolescents ( 213 Hispanic , 148 White , and 110 Black ) referred for drug abuse treatment at 8 community treatment agencies nationwide . R and omization encompassed both adolescents ' families ( n = 480 ) and the agency therapists ( n = 49 ) who provided either TAU or BSFT services . The primary outcome was adolescent drug use , assessed monthly via adolescent self-report and urinalysis for up to 1 year post r and omization . Secondary outcomes included treatment engagement ( ≥2 sessions ) , retention ( ≥8 sessions ) , and participants ' reports of family functioning 4 , 8 , and 12 months following r and omization . RESULTS No overall differences between conditions were observed in the trajectories of self-reports of adolescent drug use . However , the median number of days of self-reported drug use was significantly higher , χ2(1 ) = 5.40 , p < .02 , in TAU ( Mdn = 3.5 , interquartile range [ IQR ] = 11 ) than BSFT ( Mdn = 2 , IQR = 9 ) at the final observation point . BSFT was significantly more effective than TAU in engaging , χ2(1 ) = 11.33 , p < .001 , and retaining , χ2(1 ) = 5.66 , p < .02 , family members in treatment and in improving parent reports of family functioning , χ2(2 ) = 9.10 , p < .011 . CONCLUSIONS We discuss challenges in treatment implementation in community setting s and provide recommendations for further research This study is a 2-year follow-up of girls with serious and chronic delinquency who were enrolled in a r and omized clinical trial conducted from 1997 to 2002 comparing multidimensional treatment foster care ( MTFC ) and group care ( N = 81 ) . Girls were referred by juvenile court judges and had an average of over 11 criminal referrals when they entered the study . A latent variable analysis of covariance model controlling for initial status demonstrated maintenance of effects for MTFC in preventing delinquency at the 2-year assessment , as measured by days in locked setting s , number of criminal referrals , and self-reported delinquency . A latent variable growth model focusing on variance in individual trajectories across the course of the study also demonstrated the efficacy of MTFC . Older girls exhibited less delinquency over time relative to younger girls in both conditions . Implication s for gender-sensitive programming for youths referred from juvenile justice are discussed OBJECTIVE We used growth mixture modeling to examine heterogeneity in treatment response in a secondary analysis of 2 r and omized controlled trials testing multidimensional family therapy ( MDFT ) , an established evidence -based therapy for adolescent drug abuse and delinquency . METHOD The first study compared 2 evidence -based adolescent substance abuse treatments : individually focused cognitive-behavioral therapy and MDFT in a sample of 224 urban , low-income , ethnic minority youths ( average age = 15 years , 81 % male , 72 % African American ) . The second compared a cross-systems version of MDFT ( MDFT-detention to community ) with enhanced services as usual for 154 youths , also primarily urban and ethnic minority ( average age = 15 years , 83 % male , 61 % African American , 22 % Latino ) , who were incarcerated in detention facilities . RESULTS In both studies , the analyses supported the distinctiveness of 2 classes of substance use severity , characterized primarily by adolescents with higher and lower initial severity ; the higher severity class also had greater psychiatric comorbidity . In each study , the 2 treatments showed similar effects in the classes with lower severity/frequency of substance use and fewer comorbid diagnoses . Further , in both studies , MDFT was more effective for the classes with greater overall substance use severity and frequency and more comorbid diagnoses . CONCLUSIONS Results indicate that for youths with more severe drug use and greater psychiatric comorbidity , MDFT produced superior treatment outcomes OBJECTIVE Knowledge of treatment response for alcohol and drug problems among adults is mounting ; less is known about long-term outcome for adolescents who receive treatment for alcohol and drug problems . The current study examined youth substance involvement over 4 years ( using five waves of data collection ) following treatment for alcohol and drug abuse . METHOD A cohort of youth ( N = 162 , 60 % male ) treated during adolescence ( mean age = 16 years ) was followed into young adulthood , a period associated with stabilization of alcohol use patterns and elevated risk for life problems secondary to both alcohol and drug use . Participants ( 14 - 18 years old ) were consecutive admissions to inpatient adolescent alcohol and drug treatment centers in San Diego that were abstinence focused and based on the 12-step approach . RESULTS Alcohol and other drug use were reduced during the 4 years posttreatment , with the exception of nicotine . The greatest prevalence reduction occurred for stimulants ; modest changes were evident in alcohol and marijuana use . Nicotine was the most commonly used substance throughout the 4 years after treatment . Several distinct substance involvement trajectories were evident during the 4 years following treatment . CONCLUSIONS Alcohol and drug use patterns during the 4 years following treatment highlight both changes and diversity in substance involvement as youth make the transitions from middle to late adolescence and into young adulthood . Findings demonstrate the importance of identifying transitional periods and the need for alternative intervention strategies that may help the progression of this population into young adulthood We report the results of a growth model analysis of the impact of a Family Empowerment Intervention ( FEI ) on the heavy drinking over a 36-month follow-up period among youths processed at the Hillsborough County Juvenile Assessment Center . Families involved in the project were r and omly assigned to either receive an Extended Services Intervention ( ESI ) or the FEI . Families in the ESI group received monthly phone contacts and , if indicated , referral information ; FEI families received three one-hour , home-based meetings per week for approximately 10 weeks from a clinician-trained paraprofessional . By seeking to improve family functioning by empowering parents , it was hypothesized that target youths ' behavior and psychosocial functioning would improve . Although the difference between FEI and ESI was not significant , the reported frequency of getting very high or drunk on alcohol declined more over time for FEI completers than FEI noncompleters . The results provide support for the impact of the FEI services This study evaluated the effectiveness and cost-effectiveness of two types of outpatient treatment with and without Assertive Continuing Care ( ACC ) for 320 adolescents with substance use disorders . Study participants were r and omly assigned to one of four conditions : ( a ) Chestnut 's Bloomington Outpatient Treatment ( CBOP ) without ACC ; ( b ) CBOP with ACC ; ( c ) Motivational Enhancement Therapy/Cognitive Behavior Therapy-7 session model ( MET/CBT7 ) without ACC ; and ( d ) MET/CBT7 with ACC . All study conditions attained high rates of participant engagement and retention . Follow-up interviews were completed with over 90 % of the adolescents at three , six , nine , and 12 months after treatment admission . There was a significant time by condition effect over 12 months , with CBOP having a slight advantage for average percentage of days abstinent . Unlike previous findings that ACC provided incremental effectiveness following residential treatment , there were no statistically significant findings with regard to the incremental effectiveness of ACC following outpatient treatment . Analysis of the costs of each intervention combined with its outcomes revealed that the most cost-effective condition was MET/CBT7 without ACC Evaluated the effectiveness of juvenile drug court for 161 juvenile offenders meeting diagnostic criteria for substance abuse or dependence and determined whether the integration of evidence -based practice s enhanced the outcomes of juvenile drug court . Over a 1-year period , a four-condition r and omized design evaluated outcomes for family court with usual community services , drug court with usual community services , drug court with multisystemic therapy , and drug court with multisystemic therapy enhanced with contingency management for adolescent substance use , criminal behavior , symptomatology , and days in out-of-home placement . In general , findings supported the view that drug court was more effective than family court services in decreasing rates of adolescent substance use and criminal behavior . Possibly due to the greatly increased surveillance of youths in drug court , however , these relative reductions in antisocial behavior did not translate to corresponding decreases in rearrest or incarceration . In addition , findings supported the view that the use of evidence -based treatments within the drug court context improved youth substance-related outcomes . Clinical and policy implication s of these findings are discussed Youth substance abuse relapse prevention was examined as a function of patients ' situational self-efficacy ( SE ) , their confidence to abstain from substance use in high-risk situations . An increase in SE has been shown to be enhanced by cognitive behavioral therapy ( CBT ) in adults . Eighty-eight adolescent substance abusers were r and omly assigned to either CBT or psycho-education ( PET ) group therapy . Substance use and SE were assessed at end of treatment , 3- and 9-months after the end of planned treatment . Increased SE predicted subsequent abstinence independently from drug urinalysis and treatment condition only during treatment , while previous substance use predicted subsequent self-efficacy . CBT was not differentially effective than PET in promoting SE . It is recommended that potential mediators and moderators of SE in the treatment of adolescent substance abuse should be further explored OBJECTIVE To describe the development and initial evaluation of the Coping Course , a cognitive-behavioral group intervention design ed to enhance general coping and problem-solving skills among incarcerated youth . METHOD Between 2001 and 2002 , 76 male adolescents incarcerated at a youth correctional facility were assessed by question naire and r and omly assigned to either the Coping Course ( n = 46 ) or usual care ( n = 30 ) . Participants repeated the question naire after completion of the intervention . A second correctional facility served as an additional source of control group data ( n = 62 ) . RESULTS Significant condition x time effects were present for seven of the examined measures : Youth Self-Report externalizing scores , three measures from the Life Attitudes Scale , self-esteem , one measure of social adjustment , and cognitive-behavioral therapy knowledge . Age and race/ethnicity did not moderate effects . Comparing control group participants with youth at a separate correctional facility who did not receive the Coping Course indicated that change was uniquely associated with participation in the intervention . CONCLUSIONS Our goal was to take an efficacious adolescent depression group intervention and modify it for use with youth in correctional facilities . Preliminary findings are promising and provide evidence for future research of cognitive-behavioral group treatments with incarcerated youth OBJECTIVE A r and omized trial assessed the effectiveness of a 2-level strategy for implementing evidence -based mental health treatments for delinquent youth . METHOD A 2 x 2 design encompassing 14 rural Appalachian counties included 2 factors : ( a ) the r and om assignment of delinquent youth within each county to a multisystemic therapy ( MST ) program or usual services and ( b ) the r and om assignment of counties to the ARC ( for availability , responsiveness , and continuity ) organizational intervention for implementing effective community-based mental health services . The design created 4 treatment conditions ( MST plus ARC , MST only , ARC only , control ) . Outcome measures for 615 youth who were 69 % male , 91 % Caucasian , and aged 9 - 17 years included the Child Behavior Checklist and out-of-home placements . RESULTS A multilevel , mixed-effects , regression analysis of 6-month treatment outcomes found that youth total problem behavior in the MST plus ARC condition was at a non clinical level and significantly lower than in other conditions . Total problem behavior was equivalent and at non clinical levels in all conditions by the 18-month follow-up , but youth in the MST plus ARC condition entered out-of-home placements at a significantly lower rate ( 16 % ) than youth in the control condition ( 34 % ) . CONCLUSIONS Two-level strategies that combine an organizational intervention such as ARC and an evidence -based treatment such as MST are promising approaches to implementing effective community-based mental health services . More research is needed to underst and how such strategies can be used effectively in a variety of organizational context s and with other types of evidence -based treatments The objective of this study was to compare the efficacy of cognitive behavioral therapy ( CBT ) versus psychoeducational therapy ( PET ) for adolescent substance abusers . Eighty-eight consecutively referred predominantly dually diagnosed adolescents were r and omized to one of two eight-week , outpatient group psychotherapy conditions . Drug urinalysis and the Teen-Addiction Severity Index ( T-ASI ) were used as outcome measurements . Treatment completion rate was 86 % , follow-up location rate was 95 % , and rates of posttreatment at 3- and 9-month follow-up evaluation were 80 % and 65 % , respectively . Comorbid conduct disorder was significantly associated with treatment noncompletion and reduced follow-up rate
Output:
| Conclusions The systematic review identified instruments from the clinical field suitable to evaluate systemic family interventions in a health economic framework .
None of them had preference-weights available . |
MS211491 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
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Input: PURPOSE Single-variable analyses have associated physical activity , diet , and obesity with survival after breast cancer . This report investigates interactions among these variables . PATIENTS AND METHODS A prospect i ve study was performed of 1,490 women diagnosed and treated for early-stage breast cancer between 1991 and 2000 . Enrollment was an average of 2 years postdiagnosis . Only seven women were lost to follow-up through December 2005 . RESULTS In univariate analysis , reduced mortality was weakly associated with higher vegetable-fruit consumption , increased physical activity , and a body mass index that was neither low weight nor obese . In a multivariate Cox model , only the combination of consuming five or more daily servings of vegetables-fruits , and accumulating 540 + metabolic equivalent tasks-min/wk ( equivalent to walking 30 minutes 6 d/wk ) , was associated with a significant survival advantage ( hazard ratio , 0.56 ; 95 % CI , 0.31 to 0.98 ) . The approximate 50 % reduction in risk associated with these healthy lifestyle behaviors was observed in both obese and nonobese women , although fewer obese women were physically active with a healthy dietary pattern ( 16 % v 30 % ) . Among those who adhered to this healthy lifestyle , there was no apparent effect of obesity on survival . The effect was stronger in women who had hormone receptor-positive cancers . CONCLUSION A minority of breast cancer survivors follow a healthy lifestyle that includes both recommended intakes of vegetables-fruits and moderate levels of physical activity . The strong protective effect observed suggests a need for additional investigation of the effect of the combined influence of diet and physical activity on breast cancer survival Objective We examined the association between body mass index ( BMI ) around the time of diagnosis , weight change post-diagnosis , and breast cancer prognosis in a prospect i ve cohort study of 1,692 breast cancer survivors . Methods Pre-diagnosis weight , weight at study entry , and height was obtained from mailed question naires and then weight change and BMI were calculated . After approximately seven years of follow-up , 207 recurrences , 99 deaths due to breast cancer , and 162 deaths due to any cause were reported . Delayed entry Cox proportional hazard models were used to estimate hazard ratios ( HR ) and 95 % confidence intervals ( CI ) , controlling for treatment and known prognostic factors . Results Being obese one year before diagnosis was associated with an increased risk of death from any cause ( HR = 1.6 ; 95 % CI : 1.1–2.3 ) and a suggestion of increased risk of death from breast cancer ( HR = 1.6 ; 95 % CI : 0.9–2.7 ) . However , weight gain up to four years after a breast cancer diagnosis was not associated with an increased risk of recurrence or death from any cause nor did moderate weight loss ( 5–10 % ) decrease risk of these outcomes . There was some evidence that women who had larger weight losses ( ≥10 % ) between pre-diagnosis and study entry had an increased risk of recurrence ( HR = 1.7 ; 95 % CI 1.0–2.6 ) and death due to any cause ( HR = 2.1 ; 95 % CI 1.3–3.4 ) compared to being weight stable . This elevated risk was more pronounced among women who were obese before diagnosis ( BMI ≥ 30 kg/m2 ) or who had ER− or PR− tumors . Conclusion We found that being obese before breast cancer diagnosis was associated with increased risk of recurrence and poorer survival , corroborating results from previous studies . However , weight gain after diagnosis did not confer additional risk . Body weight pre-diagnosis appears to be the strongest predictor of an adverse breast cancer prognosis The association between anthropometric indices and the risk of breast cancer was analyzed using pooled data from seven prospect i ve cohort studies . Together , these cohorts comprise 337,819 women and 4,385 incident invasive breast cancer cases . In multivariate analyses controlling for reproductive , dietary , and other risk factors , the pooled relative risk ( RR ) of breast cancer per height increment of 5 cm was 1.02 ( 95 % confidence interval ( CI ) : 0.96 , 1.10 ) in premenopausal women and 1.07 ( 95 % CI : 1.03 , 1.12 ) in postmenopausal women . Body mass index ( BMI ) showed significant inverse and positive associations with breast cancer among pre- and postmenopausal women , respectively ; these associations were nonlinear . Compared with premenopausal women with a BMI of less than 21 kg/m2 , women with a BMI exceeding 31 kg/m2 had an RR of 0.54 ( 95 % CI : 0.34 , 0.85 ) . In postmenopausal women , the RRs did not increase further when BMI exceeded 28 kg/m2 ; the RR for these women was 1.26 ( 95 % CI : 1.09 , 1.46 ) . The authors found little evidence for interaction with other breast cancer risk factors . Their data indicate that height is an independent risk factor for postmenopausal breast cancer ; in premenopausal women , this relation is less clear . The association between BMI and breast cancer varies by menopausal status . Weight control may reduce the risk among postmenopausal women Purpose : The purpose of this retrospective study was to determine the association and prognostic value of body mass index ( BMI ) at the time of initial diagnosis in patients with locally advanced breast cancer ( LABC ) . The analysis includes the subsets of inflammatory ( IBC ) and noninflammatory ( non-IBC LABC ) breast cancer . Experimental Design : We identified 602 patients who had LABC treated on prospect i ve clinical trials . BMI was divided into three groups : ( a ) ≤24.9 ( normal/underweight ) , ( b ) 25.0 to 29.9 ( overweight ) , and ( c ) ≥30 ( obese ) . Kaplan-Meier product limit method was used to estimate survival outcomes . Cox proportional hazards were used to determine associations between survival and BMI and to test for an interaction between BMI and breast cancer type . Results : Eighty-two percent had non-IBC LABC and 18 % had IBC . Obese patients tended to have a higher incidence of IBC compared with overweight and normal/underweight groups ( P = 0.01 ) . Median follow up was 6 years for all patients . Median overall survival ( OS ) and recurrence-free survival ( RFS ) were 8.8 and 5.9 years , respectively . Patients with LABC who were obese or overweight had a significantly worse OS and RFS ( P = 0.001 ) and a higher incidence of visceral recurrence compared with normal/underweight patients . In a multivariable model , BMI remained significantly associated with both OS and RFS for the entire cohort . The interactions between BMI and LABC subsets and between BMI and menopausal status were not statistically significant . Conclusion : Patients with LABC and high BMI have a worse prognosis . Evaluation of the biological factors associated with this observation can provide tools for additional therapeutic interventions Substantial observational epidemiological evidence exists that physical activity and weight control are associated with decreased risk of postmenopausal breast cancer . Uncertainty remains regarding several aspects of these associations , including the effect of possible confounding factors on these associations . We present the rationale and design for two r and omized controlled trials that can help resolve this uncertainty . In a 5-year prevention trial conducted among women at high risk of breast cancer , the primary endpoint would be breast cancer incidence . For a comparable survivorship trial , the primary endpoint would be the disease-free interval and secondary endpoints would be breast cancer recurrence-free interval , second primary breast cancer , and total invasive plus in situ breast cancer . A set of inclusion and exclusion criteria is proposed for both trials . Intervention goals are the same for both trials . Goals for the weight control intervention would be , for women whose body mass index ( BMI ) is greater than 25 kg/m(2 ) , to lose 10 % of body weight and , for women whose BMI is less than or equal to 25 kg/m(2 ) , to avoid weight gain . The goal for the physical activity intervention would be to achieve and maintain regular participation in a moderate-intensity physical activity program for a total of 150 - 225 minutes over at least 5 days per week . Sample size calculations are based on alternative assumptions about hazard ratio , adherence , follow-up duration , and power and are presented for the primary prevention and survivorship trials . Although both studies could enhance our underst and ing of breast cancer etiology and benefit public health , practical considerations , including smaller sample size , ease of recruitment , and reduced likelihood of early termination , favor the survivorship trial at this time A historical prospect i ve study was conducted at the Mercy Hospital of Pittsburgh , Pennsylvania ( USA ) , to study the role of post-menopausal obesity in the recurrence and survival of breast cancer . Records from 301 post-menopausal women diagnosed with breast cancer from 1977 to 1985 were followed for at least 5 years from data supplied by the Tumor Registry and medical records . Data collected included age , height , weight , race , hormone receptor status , stage and size of tumour , number of positive nodes , site of distant metastasis , first course of treatment , and 5 year recurrence and survival . Forty-five per cent of patients were obese ( n = 136 ) , while 55 % were non-obese ( n = 165 ) . Obesity was defined by the Quetelet index ( patients with values > 27 were considered obese ) . The recurrence rates for the obese and non-obese groups were 40 % and 39 % respectively , and were not significantly different . Univariate and multivariate analyses showed that there was no significant association between obesity in post-menopausal women and likelihood of recurrence of or death from breast cancer Background : Obesity has been shown to be an indicator of poor prognosis for patients with primary breast cancer ( BC ) regardless of the use of adjuvant systemic therapy . Patients and methods : This is a retrospective analysis of 2,887 node-positive BC patients enrolled in the BIG 02 - 98 adjuvant study , a r and omised phase III trial whose primary objective was to evaluate disease-free survival ( DFS ) by adding docetaxel to doxorubicin-based chemotherapy . In the current analysis , the effect of body mass index ( BMI ) on DFS and overall survival ( OS ) was assessed . BMI was obtained before the first cycle of chemotherapy . Obesity was defined as a BMI ≥ 30 kg/m² . Results : In total , 547 ( 19 % ) patients were obese at baseline , while 2,340 ( 81 % ) patients were non-obese . Estimated 5-year OS was 87.5 % for non-obese and 82.9 % for obese patients ( HR 1.34 ; P = 0.013 ) . Estimated 5-years DFS was 75.9 % for non-obese and 70.0 % for obese patients ( HR 1.20 ; P = 0.041 ) . In a multivariate model , obesity remained an independent prognostic factor for OS and DFS . Conclusions : In this study , obesity was associated with poorer outcome in node-positive BC patients . Given the increasing prevalence of obesity worldwide , more research on improving the treatment of obese BC patients is needed Background Breast cancer and obesity represent important public health issues in most western countries . A number of studies found a negative prognosis effect of obesity or excess of weight in woman breast cancer . However , to date , this issue remains controversial . The objectives of this study were to confirm the prognosis role of obesity on a large cohort of patients and to investigate a potential independent effect . Material s and methods We constituted a cohort of 14,709 patients who were recruited and treated at the Curie Institute ( Paris ) from 1981 to 1999 . These patients were followed prospect ively for a first unilateral invasive breast cancer without distant metastasis . Obesity was defined by a Body Mass Index ( BMI ) above 30 kg/m2 according to the World Health Organization recommendations . Results Obese patients ( 8 % ) presented more extended tumors at diagnosis time suggesting a delayed breast cancer diagnosis . However , obesity appeared as a negative prognosis factor for several events in respectively univariate and multivariate survival analysis : metastasis recurrence ( HR = 1.32[1.19–1.48 ] ; HR = 1.12[1.00–1.26 ] ) , disease free interval ( 1.20[1.08–1.32 ] ; 1.10[0.99–1.22 ] ) , overall survival ( 1.43[1.28–1.60 ] ; 1.12[0.99–1.25 ] ) and second primary cancer outcome ( 1.57[1.19–2.07 ] ; 1.43[1.09–1.89 ] ) . Even if obese patients presented more advanced tumors at diagnosis time , multivariate analysis showed that there was a relevant independent effect . Other BMI codings , distinguishing overweight patients or using BMI as a continuous variable , showed a consistent correlation between BMI ’s value and prognosis effect . Interaction analysis revealed a more important obesity effect in the presence of tumor estrogen receptors and among limited extent tumors . Conclusions This survey confirms the prognosis role of obesity on one of the largest cohort by investigating several prognosis events . While independent obesity effect linked to hormonal disorders appeared consistent as obesity ’s mechanism , we stress that obesity prognosis effect was also related to
Output:
| Women with breast cancer , who are obese , have poorer survival than women with breast cancer , who are not obese .
However , no study has eluci date d the causal mechanism and there is currently no evidence that weight loss after diagnosis improves survival .
Consequently , there is currently no reason to place the additional burden of weight loss on women already burdened with a diagnosis of cancer . |
MS211492 | ***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 Eckerson , JM , Bull , AJ , Baechle , TR , Fischer , CA , O’Brien , DC , Moore , GA , Yee , JC , and Pulverenti , TS . Acute ingestion of sugar-free red bull energy drink has no effect on upper body strength and muscular endurance in resistance trained men . J Strength Cond Res 27(8 ) : 2248–2254 , 2013—Consumption of energy drinks by both recreational and competitive athletes has increased dramatically in recent years . The primary ingredients in many energy drinks include caffeine ( CAF ) in various forms and taurine . The purpose of this r and omized , double-blind , crossover study was to examine the effect of sugar-free ( SF ) Red Bull ( RB ) containing CAF and taurine to a CAF only drink and a SF CAF-free placebo ( PL ) on 1 repetition maximum ( 1RM ) bench press ( BP ) and the volume load ( VL ; repetitions × kg at 70 % 1RM ) during one BP set to failure in experienced lifters . Seventeen college-age men r and omly received the following : ( A ) 500 mL of SF-RB containing CAF ( 160 mg ) and taurine ( 2000 mg ) ; ( B ) 500 mL of a SF drink containing CAF only ( 160 mg ) ; or ( C ) a SF CAF-free 500 mL PL drink 60 minutes before testing on 3 separate occasions . After a st and ard warm-up , the 1RM was determined for each subject and , after 5 minutes rest , they completed repetitions to failure at 70 % of their 1RM to assess VL . Differences between trials for 1RM BP and the VL were identified using repeated measures analysis of variance ( p < 0.05 ) . The results indicated that neither SF-RB nor the CAF drink had any effect on 1RM BP ( 115.13 ± 16.19 kg and 114.87 ± 16.16 kg , respectively ) or VL ( 1173.08 ± 170.66 kg and 1164.14 ± 147.03 kg , respectively ) compared with PL ( 1RM = 114.07 ± 16.09 kg ; VL = 1141.46 ± 193.41 kg ) . Although the CAF content in the energy drinks used in the present study was low ( ∼2.0 mg/kg ) , the finding of no effect of the CAF containing energy drinks for 1RM BP are in agreement with previous studies using intakes up to 6.0 mg/kg . These findings suggest that SF-RB has no effect on upper body 1RM strength or VL in resistance trained men PURPOSE The objective of this study is to determine the effects of a caffeine-containing energy drink on female volleyball players ' performance . METHODS Thirteen elite female volleyball players ingested 3 mg·kg of caffeine with an energy drink or the same drink without caffeine ( placebo drink ) in a double-blind and r and omized study . Then , participants performed the following : st and ing spike , jumping spike , spike jump , blocking jump , squat jump , countermovement jump , manual dynamometry , and the agility t-test . A simulated volleyball game was played , videotaped , and notated afterward . RESULTS In comparison to the placebo drink , the ingestion of the caffeinated energy drink increased the ball velocity in the st and ing spike ( 19.2 ± 2.1 vs 19.7 ± 1.9 m·s , P = 0.023 ) and in the jumping spike ( 17.9 ± 2.2 vs 18.8 ± 2.2 m·s , P = 0.038 ) and the jump height in the squat jump ( 28.1 ± 3.2 vs 29.4 ± 3.6 cm , P = 0.028 ) , countermovement jump ( 32.0 ± 4.6 vs 33.1 ± 4.5 cm , P = 0.018 ) , spike jump ( 43.3 ± 4.7 vs 44.4 ± 5.0 cm , P = 0.025 ) , and block jump ( 35.2 ± 5.1 vs 36.1 ± 5.1 cm , P = 0.044 ) . Furthermore , the caffeinated energy drink decreased the time needed to complete the agility t-test ( 11.1 ± 0.5 vs 10.9 ± 0.3 s , P = 0.036 ) . During the game , the volleyball actions categorized as successful were more frequent with the caffeinated energy drink ( 34 % ± 9 % vs 45 % ± 9 % , P < 0.001 ) , whereas imprecise actions decreased ( 28 % ± 7 % vs 14 % ± 9 % , P < 0.001 ) when compared with the placebo drink . CONCLUSION Commercially available energy drinks can significantly improve physical performance in female volleyball players . Increased physical performance led to improved accuracy during an actual volleyball match Background The consumption of beverages containing caffeine and taurine before exercising has been associated with increased physical and psychological performances and has been promoted to support the emotional state and provide vitality to consumers . However , there are contradictory results on these issues , it is not clear the effect of every major compound in relation to the whole effect of the beverages and there is a lack in knowledge about their degree of safety for consumption . Methods This study used a double-blind , placebo controlled , r and omized , crossover design . Fourteen male volunteer soldiers from the Colombian army performed different tests to measure their cardiorespiratory fitness ( VO2max and maximum heart rate ) , time to exhaustion , strength ( isometric strength ) , power ( vertical jump ) , concentration ( Grid test ) and memory ( Digits test ) after drinking 250íml of one of the following beverages : one with 80ímg caffeine , one with 1000ímg taurine , one with 80ímg caffeine plus 1000ímg taurine , a commercial energy drink ( Red Bullí ) or a placebo drink . Subjects were caffeine-consumers that avoided caffeine during the day of evaluation . All beverages were matched in flavor and other organoleptic properties to the commercial one , were bottled in dark plastic bottles and were administered in identical conditions to the participants . Differences between treatments were assessed using repeated measures and analysis of variance . Results The mean í SD values of VO2max , maximum heart rate , time to exhaustion , right h and grip strength , left h and grip strength , vertical jump , Grid test and Digits test were 61.3 í 6.2íml/kg.min , 196 í 6.8 beats per min , 17 í 1.2ímin , 56.8 í 6.6íkgf , 53.1 í 5.9íkgf , 41.1 í 3.8ícm , 19.9 í 5.9 observed digits and 10.9 í 3.1 remembered digits after drinking a placebo drink . Comparisons among the commercial drink , caffeine , taurine , caffeine plus taurine and placebo treatments did not show statistically differences in the results of the performed tests . No adverse effects were reported by the participants . Conclusion The consumption of caffeine ( 80ímg ) and taurine ( 1000ímg ) or their combination does not increase the physical and cognitive ability in young adults during exercise Abstract Phillips , MD , Rola , KS , Christensen , KV , Ross , JW , and Mitchell , JB . Preexercise energy drink consumption does not improve endurance cycling performance but increases lactate , monocyte , and interleukin-6 response . J Strength Cond Res 28(5 ) : 1443–1453 , 2014—The purpose of this study was to investigate the influence of an energy drink ( ED ) on cycling performance and immune-related variables . Eleven trained male cyclists ( 33.4 ± 8.9 years ; 81 ± 7.6 kg ; maximal V[Combining Dot Above]O2 , 52 ± 3.4 ml·kg−1·min−1 ) consumed 500 ml of ( a ) ED ( 2.0 g taurine , 1.2 g glucuronolactone , 160 mg caffeine , 56 g carbohydrate [ CHO ] , and B vitamins ) , ( b ) cola matched for caffeine and CHO ( CC ) , or ( c ) flavored placebo ( PL : sparking water and flavoring ) 50 minutes before racing in a r and omized , crossover design . Performance was measured as time to complete ( TTC ) a 25-mile simulated road race . Blood was collected at baseline , 30 minutes after drink consumption , during exercise at miles 5 ( M5 ) , 15 ( M15 ) , and immediately ( POEX ) and 30 minutes ( 30minPO ) after exercise . TTC was not different ( p > 0.05 ) among trials ( ED , 68.6 ± 2.7 ; CC , 68.9 ± 3.8 ; PL , 69.6 ± 3.8 minutes ) . Consumption of CC and ED elicited a mild hypoglycemia elicited a mild hypoglycemia during cycling . POEX interleukin-6 ( IL-6 ) was greatest after ED , whereas CC IL-6 was greater than PL ( 10.2 ± 1.6 , 6.7 ± 0.6 , and 4.8 ± 0.7 pg·ml−1 , respectively ; p < 0.001 ) . Cycling increased leukocyte number in all conditions with ED leukocyte number greater than that of PL at M15 ( 9.8 ± 0.6 , 8.5 ± 0.3 × 106 cells·mL−1 ) . Energy drink induced an earlier recruitment of monocytes to the blood stream than CC . Mean fat oxidation was greater in PL compared with CC ( 0.43 ± 0.06 and 0.28 ± 0.04 g·min−1 ; p = 0.033 ) but did not differ between ED ( 0.32 ± 0.06 ) and PL . Lactate was higher in ED compared with CC and PL at M5 and M15 ( p = 0.003 ) , but there was no significant influence of either ED or CC on performance . Carbohydrate and caffeine consumption before endurance cycling significantly increased the IL-6 release and leukocytosis , and the additional ingredients in ED seem to have further augmented these responses Background The purpose of this study was to examine the effect of a pre-exercise high energy drink on reaction time and anaerobic power in competitive strength/power athletes . In addition , the effect of the pre-exercise drink on subjective feelings of energy , fatigue , alertness and focus was also explored . Methods Twelve male strength/power athletes ( 21.1 ± 1.3 y ; 179.8 ± 7.1 cm ; 88.6 ± 12.1 kg ; 17.6 ± 3.3 % body fat ) underwent two testing sessions administered in a r and omized and double-blind fashion . During each session , subjects reported to the Human Performance Laboratory and were provided with either 120 ml of a high energy drink ( SUP ) , commercially marketed as Redline Extreme ® or 120 ml of a placebo ( PL ) that was similar in taste and appearance but contained no active ingredients . Following consumption of the supplement or placebo subjects rested quietly for 10-minutes prior to completing a survey and commencing exercise . The survey consisted of 4 questions asking each subject to describe their feelings of energy , fatigue , alertness and focus for that moment . Following the completion of the question naire subjects performed a 2-minute quickness and reaction test on the Makoto testing device ( Makoto USA , Centennial CO ) and a 20-second Wingate Anaerobic Power test . Following a 10-minute rest subjects repeated the testing sequence and after a similar rest period a third and final testing sequence was performed . The Makoto testing device consisted of subjects reacting to both a visual and auditory stimulus and striking one out of 30 potential targets on three towers . Results Significant difference in reaction performance was seen between SUP and PL in both average number of targets struck ( 55.8 ± 7.4 versus 51.9 ± 7.4 , respectively ) and percent of targets struck ( 71.9 ± 10.5 % versus 66.8 ± 10.9 % , respectively ) . No significant differences between trials were seen in any anaerobic power measure . Subjective feelings of energy ( 3.5 ± 0.5 versus 3.1 ± 0.5 ) and focus ( 3.8 ± 0.5 versus 3.3 ± 0.7 ) were significantly higher during SUP compared to PL , respectively . In addition , a trend towards an increase in average alertness ( p = 0.06 ) was seen in SUP compared to P. Conclusion Results indicate a significant increase in reaction performance , with no effect on anaerobic power performance . In addition , ingestion of this supplement significantly improves subjective feelings of focus and energy in male strength/power athletes Background Currently , there are few studies on the cardiovascular and fatigue effects of commercially available energy drinks . This study investigated the effects of Monster energy drink ( Monster Beverage Corporation , Corona , California ) , on resting heart rate ( HR ) , heart rate variability ( HRV )
Output:
| Conclusion ED ingestion improved performance in muscle strength and endurance , endurance exercise tests , jumping and sport-specific actions .
However , the improvement in performance was associated with taurine dosage |
MS211493 | ***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 A new generation of ITI implants , including a hollow cylinder , a hollow screw , and a solid screw , was described in 1988 . Currently , the solid screw is the main alternative . PURPOSE The aim of this study was to gain further clinical documentation of ITI solid-screw implants used in the edentulous upper jaw . This is a report 1 year after loading . MATERIAL S AND METHODS Twenty-eight patients with edentulous upper jaws ( mean age , 57 yr ) were supplied with four to eight ITI solid-screw implants in the upper jaw . In total , 167 implants ( 3.3 and 4.1 mm in diameter ) were inserted . The implants were loaded about 7 months postoperatively . All patients were supplied with fixed screw-retained bridges . RESULTS Twelve implants failed : 10 prior to loading and 2 after . Overall implant survival rate was 92.8 % . Three of the five patients with implant loss were smokers . Signs of peri-implantitis were found in seven patients , affecting 12 implants . Mean marginal bone level at the loading of the implants ( 7 months after insertion ) was situated 4.7 mm from the reference point of the implant . There was no significant change between loading and the 1-year examination . However , at several implants , the bone level at baseline was situated far apical of the reference point , indicating a bone loss before loading . CONCLUSIONS The ITI screw implants , used in the edentulous upper jaw , had a survival rate of 92.8 % . Mean bone loss between loading and the 1-year examination was 0.1 mm . Some implants had a bone level indicating a significant bone loss before loading . Peri-implantitis was found at about 7.2 % of the implants inserted and at 25 % of the failing implants BACKGROUND Brånemark fixtures were originally placed in two stages , whereas titanium plasma-sprayed ( TPS ) solid-screws are placed in one stage . Long-term survival rates for both types of implants are excellent . Excellent survival rates have also been reported for machined screw-shaped ( MS ) titanium implants placed in one stage . A small number of studies have compared different implant systems and methods of implant placement . PURPOSE The purpose of this study is to report clinical outcomes from a prospect i ve longitudinal , multicenter study comparing Brånemark MS fixtures ( Nobel Biocare , Yorba Linda , California , USA ) placed in either one or two stages with a one-stage TPS system ( ITI Straumann , Waldenburg , Switzerl and ) . METHODS A protocol was design ed to compare implant survival rates , changes in crestal bone for titanium MS fixtures placed in one and two stages , and plasma-sprayed solid-screw fixtures placed in one surgical stage . Twenty-nine patients ranging in age from 24 to 82 years received MS fixtures in one stage . The average age for males was 58 years ( n = 11 ) , whereas the ages for females ( n = 18 ) ranged from 15 to 84 years ( average 58 years ) . Twenty-nine patients received machined titanium fixtures placed in two stages . There were 20 females ranging in age from 23 to 74 years ( average 54 years ) and 9 females ranging from 24 to 74 years ( average 46 years ) . Twenty-five patients received TPS fixtures . There were 15 males , ranging in age from 57 to 79 ( average 70 ) , and 10 females , ranging in age from 40 to 83 years ( average 62 years ) . Bone quality and quantity were determined from radiographs and during site preparation . Patient age , sex , location of implant placement according to jaw , length of fixtures , and number of lost fixtures were entered onto computer code sheets and continuously entered into a locked computer system . For one- and two-stage MS fixtures , nonst and ardized periapical radiographs were taken at abutment connection and follow-up . Solid screws were x-rayed at prostheses connection and follow-up . The average time between implant restoration and radiographic follow-up was 15 months . The x-rays were scanned into a computer , and a program design ed to measure radiographs was used to determine changes in crestal bone . Measurements for one- and two-stage MS fixtures were made from the top of the implant shoulder to the first bone to implant contact mesial and distally . Plasma-sprayed screws were measured from the bottom of the implant to the coronal most bone to implant contacts mesial and distally . Mesial-distal radiographic measurements were averaged and changes were compared using the t-test for related sample s. RESULTS This report presents data from the 2- to 3-year follow-up examinations . Twenty-nine patients received 80 one-stage MS fixtures . Between 0 and 1 year , two fixtures were lost , result ing in a 97.5 % cumulative survival rate ( CSR ) . The CSR remained unchanged through the 2- to 3-year follow-up . Twenty-eight patients received 78 two-stage MS fixtures . One implant was lost prior to loading and two were lost between 0- and 1-year follow-up , yielding a 96.2 % CSR at the end of 1 year . The CSR remained unchanged through the 2- to 3-year follow-up . Twenty-three patients received 78 solid-screw plasma-sprayed screws . One implant was lost prior to loading and one between the 0- to 1-year follow-up , accounting for a 97.4 % CSR at the 2- to 3-year follow-up . Changes in bone crest measurements for one-stage titanium threaded fixtures were insignificant ( -0.11 mm , p = .08 , maxillary ; 0.07 mm , p = .42 , m and ibular ) . For two-stage MS fixtures , crestal bone loss was insignificant in maxillae ( -0.16 mm , p = .92 ) and significant in m and ibles ( -0.43 mm , p = .000 ) . There was significant bone loss for TPS implants in maxillae and m and ibles ( maxillae , 1.31 mm , p = .04 ; m and ibles , 0.98 mm , p = .000 ) . CONCLUSIONS Cumulative survival rates for MS fixtures placed in one and two stages as well as one-stage TPS screws up to the 2- to 3-year follow-up examination were similar , indicating excellent clinical results . Radiographic measurements for changes in crestal bone loss were clinical ly insignificant for fixtures placed in one stage . For two-stage fixtures , maxillary changes were insignificant , whereas m and ibular bone loss was statistically significant but clinical ly insignificant . Changes in crestal bone loss for TPS implants were statistically significant BACKGROUND A major reason for the success of modern dental implant systems has been the development of implant design s that enhance direct bone-implant interface . Surface roughness has been a factor in this success and different systems have utilized very different implant surface roughness . The major purpose of this study was to evaluate 2 similar implants with different surface roughness characteristics . METHODS Two similarly design ed , screw-type , commercially pure titanium implants , one dual acid-etched ( DAE ) and the other machined-surfaced ( MS ) , were compared in this prospect i ve , r and omized-controlled , multi-center study , in which a total of 97 patients were enrolled at a private dental practice or a university dental clinic . Both implant types were placed in each patient using a 2-stage approach with a conventional 4- to 6-month healing period . Implants supported fixed prostheses , hybrid prostheses , and overdentures as dictated by the individual patient 's need . All of the cases were followed using clinical and radiographic examinations . Criteria of success were the absence of peri-implant radiolucency , mobility , and persistent signs or symptoms of pain or infection . RESULTS Of the 432 implants ( 247 dual acid-etched , 185 machined-surfaced ) , 36 implants ( 12 dual acid-etched and 24 machined-surfaced ) have failed . The pre-loading integration success rate of the dual acid-etched implants ( 95.0 % ) was statistically higher ( P < 0.01 ) than the success rate of the machined-surfaced implants ( 86.7 % ) . At 36 months , the cumulative success rates ( CSR ) are 95.0 % for the dual acid-etched implants and 86.7 % for the machined-surfaced implants . CONCLUSIONS The difference in success rates is most likely attributed to the acid-etched surface characteristics . The greatest performance difference is observed in the conditions of poor quality or soft bone where the 3-year post-loading CSR are 96.8 % ( dual acid-etched ) and 84.8 % ( machined-surfaced ) PURPOSE This investigation was conducted to obtain preliminary roughness data on a microtextured implant surface and to determine its ability to sustain a 1-stage surgical procedure and early full occlusal loading of single-tooth restorations in humans . MATERIAL S AND METHODS Three-dimensional ( 3D ) vertical scanning interferometry was conducted on sample s of the test surface ( MTX ) and 2 control surfaces ( Osseotite and s and blasted/acid-etched [ SLA ] ) . Test implants were also placed in vivo , restored with fully occluding single-tooth restorations ( n = 27 ) after 2 months of nonsubmerged healing , and clinical ly monitored for 48 months of follow-up . RESULTS Microtexture was relatively uniform on the test surface and more r and om and irregular on the control surfaces . MTX and Osseotite were similar in some roughness parameters , but the MTX surface had a greater number of micropits that were spaced closer together ( Stylus Y lambda q ) and with higher slope values ( Stylus Y delta q ) . Cumulative life table results were 100 % for all MTX implants placed in maxillary and m and ibular jaw locations , and no discernible marginal bone changes were observed . Overall implant success was 100 % after 4 years of clinical functioning . DISCUSSION The findings of this study appear promising but should be considered preliminary , because of the limitations in the number of locations measured on each product sample and the small number of implants clinical ly studied . CONCLUSION Within the scope of the present study , MTX implants exhibited a uniform micropitted surface , as well as 100 % survival and 100 % clinical success after nonsubmerged placement , early loading with single-tooth restorations at 2 months , and 48 months of clinical functioning . ( More than 50 references . PURPOSE To evaluate the bone contact percentage around a proprietary high-temperature dual-etched ( DE ) implant surface ( Osseotite ) versus implants with machined , hydroxyapatite ( HA ) , and titanium plasma-sprayed ( TPS ) surfaces . MATERIAL S AND METHODS Each implant type was placed in rabbit tibiae of the same animal and assessed at 1 to 8 weeks . Histologic sections were prepared and analyzed histomorphometrically . RESULTS The DE implant surface achieved higher levels of bone contact percentage than the other surfaces . This enhanced contact level was apparent by 3 weeks and seen at all time intervals except 2 weeks , at which machined exceeded the DE mean . In evaluating which surface outscored the others in each individual rabbit , there was a statistically significant confidence for the DE surface ( P < .001 ) . The other 3 surfaces failed to show significance , although the numeric scores for the TPS surfaces were below r and om expectations and the machined scores were slightly above . There was no correlation between degree of roughness and bone contact percentage . DISCUSSION Arbitrarily roughening the implant surface may not result in a large change in bone conductivity . The specific texture of the DE process yielded more contact , possibly as the result of better fibrin clot retention and growth factor enhancement . CONCLUSIONS There was no advantage demonstrated in this model to an HA surface over titanium . The bone contact to the rough HA surface scored similarly to that for the TPS surface of similar roughness , and well below that for the DE titanium surface . The DE surface appeared to have an advantage in bone contact percentage , particularly in early healing in a rabbit tibia model The aim of this study was to evaluate the influence of implant microstructure on the osseointegration of immediate implants placed into infected sites . During 12 weeks , periodontitis was induced in six dogs in the areas of the first to fourth m and ibular premolars of both sides . The teeth were extracted and the implants were placed immediately . Implant placement was r and omly assigned so that for each side in the m and ible a different implant surface , a new grit-blasted/acid-etched group 1 or titanium plasma spray surface group 2 was used , totaling 36 implants in the experiment . The animals were killed 12 weeks after implant placement . Two histomorphometric analyses were performed : percentage of bone/implant contact ( BIC ) and analyses of the bone density in adjacent and distant areas from the implant surface . The results showed that the percentages of BIC were 52.7 % and 42.7 % for groups 1 and 2 , respectively . The bone density analysis revealed that the percentages of bone in the adjacent areas were 66.6 % and 58.8 % , and in the distant areas from the implants were 58.7 % and 55.8 % for groups 1 and 2 , respectively . The mean differences of BIC were verified through the Mann
Output:
| RESULTS AND DISCUSSION A huge number of the experimental investigations have demonstrated that the bone response was influenced by the implant surface topography ; smooth ( S(a)<0.5 microm ) and minimally rough ( S(a ) 0.5 - 1 mum ) surfaces showed less strong bone responses than rougher surfaces .
* Surface topography influences bone response at the micrometre level . *
Some indications exist that surface topography influences bone response at the nanometre level . * |
MS211494 | ***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 Breathlessness is a distressing symptom in advanced disease . Underst and ing its patterns , burden , and palliative care ( PC ) needs over time is important to improve patients ' quality of life . OBJECTIVES To describe and compare the courses of refractory breathlessness , functional status , distress , and PC needs in patients with advanced chronic obstructive pulmonary disease ( COPD ) or lung cancer ( LC ) over time . METHODS This was a cohort study of patients with COPD ( Stage III/IV ) or LC . Data were assessed monthly with up to 12 telephone interviews , using the modified Borg Scale , Karnofsky Performance Status Scale , Distress Thermometer , and Palliative care Outcome Scale as outcomes measures . Descriptive analysis compared all outcomes between COPD and LC at baseline and over time ( forward from study entry and backward from death ) . RESULTS A total of 82 patients ( 50 COPD and 32 LC ) , mean ( SD ) age of 67.2 ( 7.8 ) , and 36 % female were included ( 8 COPD and 23 LC deceased ) . The patients with COPD perceived higher levels of breathlessness and distress at lower functional status steadily over time . The LC patients ' breathlessness , distress , and PC needs increased , whereas functional status decreased toward death . The PC needs were similar between disease groups . Breathlessness was negatively correlated with functional status ( COPD = mean r=-0.20 , P=0.012 ; LC = mean r=-0.277 , P=0.029 ) and positively correlated with PC needs in COPD patients ( mean r=0.343 , P<0.001 ) . Death was significantly predicted by diagnosis ( LC : hazard ratio=7.84 , P<0.001 ) and functional status ( 10 % decline : hazard ratio=1.52 , P=0.001 ) . CONCLUSION The PC needs of patients with advanced COPD are comparable with LC patients , and breathlessness severity and distress are even higher . The care for COPD patients requires further improvement to address symptom burden and PC needs Background Many HIV/AIDS patients experience pain often due to advanced HIV/AIDS infection and side effects of treatment . In sub-Saharan Africa , pain management for people with HIV/AIDS is suboptimal . With survival extended as a direct consequence of improved access to antiretroviral therapy , the prevalence of HIV/AIDS related pain is increasing . As most care is provided at home , the management of pain requires patient and family involvement . Pain education is an important aspect in the management of pain in HIV/AIDS patients . Studies of the effectiveness of pain education interventions for people with HIV/AIDS have been conducted almost exclusively in western countries . Methods / design A r and omised controlled trial is being conducted at the HIV and palliative care clinics of two public hospitals in Malawi . To be eligible , patient participants must have a diagnosis of HIV/AIDS ( stage III or IV ) . Carer participants must be the individual most involved in the patient ’s unpaid care . Eligible participants are r and omised to either : ( 1 ) a 30-minute face-to-face educational intervention covering pain assessment and management , augmented by a leaflet and follow-up telephone call at two weeks ; or ( 2 ) usual care . Those allocated to the usual care group receive the educational intervention after follow-up assessment s have been conducted ( wait-list control group ) . The primary outcome is pain severity measured by the Brief Pain Inventory . Secondary outcomes are pain interference , patient knowledge of pain management , patient quality of life , carer knowledge of pain management , caregiver motivation and carer quality of life . Follow-up assessment s are conducted eight weeks after r and omisation by palliative care nurses blind to allocation . Discussion This r and omised controlled trial conducted in sub-Saharan Africa among people living with HIV/AIDS and their carers will assess whether a pain education intervention is effective in reducing pain and improving pain management , quality of life and carer motivation . Trial registration Current Controlled Trials IS RCT N72861423 A high burden of pain , symptoms and other multidimensional problems persist alongside HIV treatment . WHO policy indicates palliative care as essential throughout the disease course . This study aim ed to determine whether palliative care delivered from within an existing HIV outpatient setting improves control of pain and symptoms compared to st and ard care . A prospect i ve , longitudinal controlled design compared patient outcomes at an outpatient facility that introduced palliative care training to clinicians and stocked essential palliative care drugs , to outcomes of a cohort of patients at a similar HIV care facility with no palliative care , in Tanzania . Inclusion criteria were clinical ly significant pain or symptoms . Patients were followed from baseline fortnightly until week 10 using vali date d self-report outcome measures . For the primary pain outcome , the required sample size of 120 patients was recruited . Odds of reporting pain reduced significantly more at intervention site ( OR=0.60 , 95 % CI 0.50–0.72 ) than at control ( OR=0.85 , 95 % CI 0.80–0.90 ) , p=0.001 . For secondary outcomes , longitudinal analysis revealed significant difference in slope between intervention and control , respectively : Medical Outcomes Study -HIV ( MOS-HIV ) physical score 1.46 vs. 0.54 , p=0.002 ; MOS-HIV mental health 1.13 vs. 0.26 , p=0.006 ; and POS total score 0.84 vs. 0.18 , p=0.001 . Neither baseline CD4 nor antiretroviral therapy ( ART ) use was associated with outcome scores . These data are the first to report outcomes evaluating integrated HIV outpatient palliative care in the presence of ART . The data offer substantive evidence to underpin the existing WHO clinical guidance that states an essential role for palliative care alongside HIV treatment , regardless of prognosis Background SAIATU is a program of specially trained in-home social assistance and companionship which , since February 2011 , has provided support to end-of-life patients , enabling the delivery of better clinical care by healthcare professionals in Osakidetza ( Basque Health Service ) , in Guipúzcoa ( Autonomous Community of the Basque Country).In January 2012 , a retrospective observational study was carried out , with the aim of describing the characteristics of the service and determining if the new social service and the associated socio-health co-ordination had produced any effect on the use of healthcare re sources by end-of-life patients .The results of a comparison of a cohort of cases and controls demonstrated evidence that the program could reduce the use of hospital re sources and promote the continuation of living at home , increasing the home-based activity of primary care professionals . The objective of this study is to analyse whether a program of social intervention in palliative care ( SAIATU ) results in a reduction in the consumption of healthcare re sources and cost by end-of-life patients and promotes a shift towards a more community-based model of care . Method / design Comparative prospect i ve cohort study , with r and omised selection of patients , which will systematic ally measure patient characteristics and their consumption of re sources in the last 30 days of life , with and without the intervention of a social support team trained to provide in-home end-of-life care . For a sample of approximately 150 patients , data regarding the consumption of public healthcare re sources , SAIATU activity , home hospitalisation teams , and palliative care will be recorded . Such data will also include information dealing with the socio-demographic and clinical characteristics of the patients and attending carers , as well as particular characteristics of patient outcomes ( Karnofsky Index ) , and of the outcomes of palliative care received ( Palliative Outcome Scale).Ethical approval for the study was given by the Clinical Research Ethics Committee of Euskadi ( CREC-C ) on 10 Dec 2012 . Discussion The results of this prospect i ve study will assist in verifying or disproving the hypothesis that the in-home social care offered by SAIATU improves the efficiency of healthcare re source usage by these patients ( quality of life , symptom control).This project represents a dramatic advance with respect to other studies conducted to date , and demonstrates how , through the provision of personnel trained to provide social care for patients in the advanced stages of illness , and through strengthening the co-ordination of such social services with existing healthcare system re sources , the result ing holistic structure obtains cost savings within the health system and improves the efficiency of the system as a whole Background Patients with HIV/AIDS on Antiretroviral Therapy ( ART ) suffer from physical , psychological and spiritual problems . Despite international policy explicitly stating that a multidimensional approach such as palliative care should be delivered throughout the disease trajectory and alongside treatment , the effectiveness of this approach has not been tested in ART-experienced population s. Methods / design This mixed methods study uses a R and omised Controlled Trial ( RCT ) to test the null hypothesis that receipt of palliative care in addition to st and ard HIV care does not affect pain compared to st and ard care alone . An additional qualitative component will explore the mechanism of action and participant experience . The sample size is design ed to detect a statistically significant decrease in reported pain , determined by a two tailed test and a p value of ≤0.05 . Recruited patients will be adults on ART for more than one month , who report significant pain or symptoms which have lasted for more than two weeks ( as measured by the African Palliative Care Association ( APCA ) African Palliative Outcome Scale ( POS ) ) . The intervention under trial is palliative care delivered by an existing HIV facility nurse trained to a set st and ard . Following an initial pilot the study will be delivered in two African countries , using two parallel independent Phase III clinical RCTs . Qualitative data will be collected from semi structured interviews and documentation from clinical encounters , to explore the experience of receiving palliative care in this context . Discussion The data provided by this study will provide evidence to inform the improvement of outcomes for people living with HIV and on ART in Africa . Clinical Trials.gov Identifier : Background : Although communicating effectively with patients receiving palliative care can be difficult , it may contribute to maintaining or enhancing patients ’ quality of life . Little is known about the effect of training general practitioners in palliative care – specific communication . We hypothesized that palliative care patients of general practitioners exposed to the ‘ Availability , Current issues and Anticipation ’ communication training programme would report better outcomes than patients of control general practitioners . Aim : To evaluate the effectiveness of the Availability , Current issues and Anticipation training programme for general practitioners on patient-reported outcomes . Design : In a controlled trial , general practitioners followed the Availability , Current issues and Anticipation programme or were part of the control group . Patients receiving palliative care of participating general practitioners completed the Palliative Care Outcome Scale , the European Organisation for Research and Treatment of Cancer Quality of Life Question naire Core 15 Palliative , the Rest & Peace Scale , the Patient Satisfaction Question naire – III and the Availability , Current issues and Anticipation Scale , at baseline and 12 months follow-up . We analysed differences between groups using linear mixed models . Trial registration : IS RCT N56722368 . Setting / participants : General practitioners who attended a 2-year Palliative Care Training Course in the Netherl and s. Results : Question naire data were available for 145 patients ( 89 in intervention and 56 in control group ) . We found no significant differences over time between the intervention and control groups in any of the five outcome measures . Ceiling effects were observed for the Rest & Peace Scale , Patient Satisfaction Question naire – III and Availability , Current issues and Anticipation Scale . Conclusion : General practitioner participation in the Availability , Current issues and Anticipation training programme did not have a measurable effect on any of the outcomes investigated . Patients reported high levels of satisfaction with general practitioner care , regardless of group assignment . Future research might focus on general practitioners without special interest in palliative care CONTEXT Most patient-reported outcome measurement tools in multiple sclerosis ( MS ) are geared toward less severely affected patients . Palliative care outcome measures have not been vali date d in patients with MS . OBJECTIVES To assess the psychometric properties of the Core-Palliative Care Outcome Scale ( Core-POS ) and POS-MS-Symptoms ( POS-MS-S ) in patients severely affected by MS . METHODS Secondary analyses were conducted on data from a Phase II trial of palliative care in MS . Patients completed assessment s using the following five scales : Core-POS , POS-MS-S , the Multiple Sclerosis Impact Scale , the United Kingdom Neurological Disability Scale , and the Exp and ed Disability Status Scale . Data quality , scaling assumptions , acceptability , internal consistency , and construct validity of the Core-POS and POS-MS-S were determined using st and ard psychometric methods . RESULTS The 46 participants had a mean ±SD age of 52.8 ±10.6 years . The mean Exp and ed Disability Status Scale score was 7.9 ± 1.2 . Missing data were low ( 0 and 0.2 % for the Core-POS and POS-MS-S , respectively ) , and floor and ceiling effects were absent . Internal consistency was good ( Cronbach 's alpha for the Core-POS and POS-MS-S were 0.72 [ 95 % CI 0.56 - 0.84 ] and 0.81 [ 95 % CI 0.72 - 0.89 ] , respectively ) . Construct validity was consistent with a priori hypotheses 17 of 20 times . CONCLUSION Psychometric analyses confirm that the Core-POS and POS-MS-S are acceptable , reliable , and valid in patients severely affected by MS OBJECTIVES In Germany since 2007 patients with advanced life-limiting
Output:
| There has been increasing use of these measures within non-cancer patient groups .
CONCLUSION The POS and STAS are now used in a wide variety of setting s and countries . |
MS211495 | ***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 —Hypertension is a leading mortality risk factor yet inadequately controlled in most affected subjects . Effective programs to address this problem are lacking . We hypothesized that an information technology – supported management program could help improve blood pressure ( BP ) control . Methods and Results —This r and omized controlled trial included 223 primary care hypertensive subjects with mean 24-hour BP > 130/80 and daytime BP > 135/85 mm Hg measured with ambulatory monitoring ( ABPM ) . Intervention subjects received a BP monitor and access to an information technology – supported adherence and BP monitoring system providing nurses , pharmacists , and physicians with monthly reports . Control subjects received usual care . The mean ( ±SD ) follow-up was 348 ( ±78 ) and 349 ( ±84 ) days in the intervention and control group , respectively . The primary end point of the change in the mean 24-hour ambulatory BP was consistently greater in intervention subjects for both systolic ( −11.9 versus −7.1 mm Hg ; P<0.001 ) and diastolic BP ( −6.6 versus −4.5 mm Hg ; P=0.007 ) . The proportion of subjects that achieved Canadian Guideline target BP ( 46.0 % versus 28.6 % ) was also greater in the intervention group ( P=0.006 ) . We observed similar BP declines for ABPM and self-recorded home BP suggesting the latter could be an alternative for confirming BP control . The intervention was associated with more physician-driven antihypertensive dose adjustments or changes in agents ( P=0.03 ) , more antihypertensive classes at study end ( P=0.007 ) , and a trend toward improved adherence measured by prescription refills ( P=0.07 ) . Conclusions —This multidisciplinary information technology – supported program that provided feedback to patients and healthcare providers significantly improved blood pressure levels in a primary care setting BACKGROUND St and ard office-based approaches to controlling hypertension show limited success . Such suboptimal hypertension control reflects in part the absence of both an infrastructure for patient education and frequent , regular blood pressure ( BP ) monitoring . We tested the efficacy of a physician-directed , nurse-managed , home-based system for hypertension management with st and ardized algorithms to modulate drug therapy , based on patients ' reports of home BP . METHODS We r and omized out patients requiring drug therapy for hypertension according to the Joint National Committee on Prevention , Detection , Evaluation , and Treatment of High Blood Pressure ( JNC VI ) criteria to receive usual medical care only ( UC , n = 76 ) or usual care plus nurse care management intervention ( INT , n = 74 ) over a 6-month period . RESULTS Patients receiving INT achieved greater reductions in office BP values at 6 months than those receiving UC : 14.2 + /- 18.1 versus 5.7 + /- 18.7 mm Hg systolic ( P < .01 ) and 6.5 + /- 10.0 versus 3.4 + /- 7.9 mm Hg diastolic , respectively ( P < .05 ) . At 6 months , we observed one or more changes in drug therapy in 97 % of INT patients versus 43 % of UC patients , and 70 % of INT patients received two or more drugs versus 46 % of UC . Average daily adherence to medication , measured by electronic drug event monitors , was superior among INT subjects ( mean + /- SD , 80.5 % + /- 23.0 % ) than among UC subjects ( 69.2 + /- 31.1 % ; t(113 ) = 2.199 , P = .03 ) . There were no significant adverse drug reactions in either group . CONCLUSIONS Telephone-mediated nurse management can successfully address many of the systems-related and patient-related issues that limit pharmacotherapeutic effectiveness for hypertension BACKGROUND Although beta-blockers and angiotensin-converting enzyme ( ACE ) inhibitors are often used together , there is a lack of quantitative evidence for the efficacy of this combination in reducing blood pressure ( BP ) . OBJECTIVE The aim of this r and omized , double-blind , placebo-controlled , crossover study was to quantify the combined effect of a beta-blocker ( atenolol ) and an ACE inhibitor ( lisinopril ) in lowering BP . METHODS Participants who were > or = 40 years of age and enrolled in the hypertension or anticoagulation clinics at St. Bartholomew 's Hospital , London , United Kingdom , were r and omized to 3 consecutive 4-week treatments consisting of atenolol 25 mg plus placebo , lisinopril 5 mg plus placebo , and atenolol 25 mg plus lisinopril 5 mg , plus a period of 2 placebos . At the end of each period , seated BP was measured in the right arm using electronic monitors . RESULTS The mean placebo-adjusted peak BP reductions among the 47 participants ( mean age , 62 [ range 42 - 82 ] years ; 75 % male ; 70 % white/30 % Asian ; mean baseline BP , 145/82 mm Hg ) who completed all 4 periods were significantly greater with the combination of both drugs than with either drug alone ( P < 0.001 ) . The systolic reductions were 22.9 mm Hg with combination treatment , 16.1 mm Hg with atenolol treatment , and 12.5 mm Hg with lisinopril treatment , and the diastolic reductions were 13.9 , 9.8 , and 6.8 mm Hg , respectively . The BP-lowering effect of the 2 drugs together was similar to that expected from the sum of each alone , allowing for the reduced effect of 1 drug given the lower pretreatment BP due to the other . The incremental systolic BP reduction from the 2 drugs together compared with 1 alone was 79 % ( 95 % CI , 54%-126 % ) of the expected additive effect , 88 % ( 95 % CI , 58%-130 % ) for diastolic BP , and 84 % ( 95 % CI , 65%-118 % ) for the mean of systolic and diastolic BP . CONCLUSIONS The combination of the beta-blocker atenolol 25 mg plus the ACE inhibitor lisinopril 5 mg was associated with a significantly greater decrease in BP compared with either alone . The BP reduction with the combination treatment was similar to and statistically consistent with the 2 drugs having additive effects . Clinical Trials Identification Number : IS RCT N97280940 Background —Hypertension is a leading risk factor for cardiovascular disease . Although control rates have improved over time , racial/ethnic disparities in hypertension control persist . Self-blood pressure monitoring , by itself , has been shown to be an effective tool in predominantly white population s , but less studied in minority , urban communities . These types of minimally intensive approaches are important to test in all population s , especially those experiencing related health disparities , for broad implementation with limited re sources . Methods and Results —The New York City Health Department in partnership with community clinic networks implemented a r and omized clinical trial ( n=900 , 450 per arm ) to investigate the effectiveness of self-blood pressure monitoring in medically underserved and largely black and Hispanic participants . Intervention participants received a home blood pressure monitor and training on use , whereas control participants received usual care . After 9 months , systolic blood pressure decreased ( intervention , 14.7 mm Hg ; control , 14.1 mm Hg ; P=0.70 ) . Similar results were observed when incorporating longitudinal data and calculating a mean slope over time . Control was achieved in 38.9 % of intervention and 39.1 % of control participants at the end of follow-up ; the time-to-event experience of achieving blood pressure control in the intervention versus control groups were not different from each other ( logrank P value = 0.91 ) . Conclusions —Self-blood pressure monitoring was not shown to improve control over usual care in this largely minority , urban population . The patient population in this study , which included a high proportion of Hispanics and uninsured persons , is understudied . Results indicate these groups may have additional meaningful barriers to achieving blood pressure control beyond access to the monitor itself . Clinical Trial Registration : http:// clinical trials.gov . Unique Identifier : BACKGROUND Out-of-office blood pressure ( BP ) measurement using home BP ( HBP ) or ambulatory BP ( ABP ) monitoring is often necessary for the accurate evaluation of hypertension . These methods have several similarities but also have major differences . Therefore , they are regarded as complementary , and there is uncertainty on how they should be applied in clinical practice . This study compared hypertension management based on clinic and ABP measurements or on HBP measurements alone . METHODS Untreated subjects with elevated BP were r and omized to treatment initiation and titration based on clinic and ABP measurements or on HBP measurements alone . Target organ damage was assessed at baseline and after 1 year of treatment with echocardiographic left ventricular mass index ( primary endpoint ) , pulse wave velocity , and urinary albumin excretion . RESULTS A total of 145 subjects were r and omized , and 116 completed the study ( mean age = 50.7±10.5 years ; 69 men ( 59 % ) ; mean follow-up = 13.4±1.4 months ) . There was no difference between the 2 arms in treatment-induced change in left ventricular mass index ( mean difference = 0.50±1.11 g/m2 ; 95 % confidence interval ( CI ) = -1.70 to 2.70 ) . Moreover , there was no difference between the 2 arms in treatment-induced changes in pulse wave velocity ( mean difference = -0.16±0.42 m/s ; 95 % CI = -0.99 to 0.66 ) , urinary albumin excretion ( mean difference = -0.85±4.28 mg/dl ; 95 % CI = -9.37 to 7.66 ) , HBP and ABP levels , and hypertension control rates . CONCLUSIONS These data suggest that HBP monitoring alone is as reliable as combined clinic and ABP measurements in monitoring the effects of antihypertensive drug treatment on BP and pre clinical target organ damage IMPORTANCE Only about half of patients with high blood pressure ( BP ) in the United States have their BP controlled . Practical , robust , and sustainable models are needed to improve BP control in patients with uncontrolled hypertension . OBJECTIVES To determine whether an intervention combining home BP telemonitoring with pharmacist case management improves BP control compared with usual care and to determine whether BP control is maintained after the intervention is stopped . DESIGN , SETTING , AND PATIENTS A cluster r and omized clinical trial of 450 adults with uncontrolled BP recruited from 14,692 patients with electronic medical records across 16 primary care clinics in an integrated health system in Minneapolis-St Paul , Minnesota , with 12 months of intervention and 6 months of postintervention follow-up . INTERVENTIONS Eight clinics were r and omized to provide usual care to patients ( n = 222 ) and 8 clinics were r and omized to provide a telemonitoring intervention ( n = 228 ) . Intervention patients received home BP telemonitors and transmitted BP data to pharmacists who adjusted antihypertensive therapy accordingly . MAIN OUTCOMES AND MEASURES Control of systolic BP to less than 140 mm Hg and diastolic BP to less than 90 mm Hg ( < 130/80 mm Hg in patients with diabetes or chronic kidney disease ) at 6 and 12 months . Secondary outcomes were change in BP , patient satisfaction , and BP control at 18 months ( 6 months after intervention stopped ) . RESULTS At baseline , enrollees were 45 % women , 82 % white , mean ( SD ) age was 61.1 ( 12.0 ) years , and mean systolic BP was 148 mm Hg and diastolic BP was 85 mm Hg . Blood pressure was controlled at both 6 and 12 months in 57.2 % ( 95 % CI , 44.8 % to 68.7 % ) of patients in the telemonitoring intervention group vs 30.0 % ( 95 % CI , 23.2 % to 37.8 % ) of patients in the usual care group ( P = .001 ) . At 18 months ( 6 months of postintervention follow-up ) , BP was controlled in 71.8 % ( 95 % CI , 65.0 % to 77.8 % ) of patients in the telemonitoring intervention group vs 57.1 % ( 95 % CI , 51.5 % to 62.6 % ) of patients in the usual care group ( P = .003 ) . Compared with the usual care group , systolic BP decreased more from baseline among patients in the telemonitoring intervention group at 6 months ( -10.7 mm Hg [ 95 % CI , -14.3 to -7.3 mm Hg ] ; P<.001 ) , at 12 months ( -9.7 mm Hg [ 95 % CI , -13.4 to -6.0 mm Hg ] ; P<.001 ) , and at 18 months ( -6.6 mm Hg [ 95 % CI , -10.7 to -2.5 mm Hg ] ; P = .004 ) . Compared with the usual
Output:
| Self-monitoring was most effective in those with fewer antihypertensive medications and higher baseline sBP up to 170 mmHg .
No differences in efficacy were seen by sex or by most comorbidities .
Self-monitoring alone is not associated with lower BP or better control , but in conjunction with co- interventions ( including systematic medication titration by doctors , pharmacists , or patients ; education ; or lifestyle counselling ) leads to clinical ly significant BP reduction which persists for at least 12 months . |
MS211496 | ***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 photopigment in the human eye that transduces light for circadian and neuroendocrine regulation , is unknown . The aim of this study was to establish an action spectrum for light-induced melatonin suppression that could help eluci date the ocular photoreceptor system for regulating the human pineal gl and . Subjects ( 37 females , 35 males , mean age of 24.5 ± 0.3 years ) were healthy and had normal color vision . Full-field , monochromatic light exposures took place between 2:00 and 3:30 A.M. while subjects ' pupils were dilated . Blood sample s collected before and after light exposures were quantified for melatonin . Each subject was tested with at least seven different irradiances of one wavelength with a minimum of 1 week between each nighttime exposure . Nighttime melatonin suppression tests ( n = 627 ) were completed with wavelengths from 420 to 600 nm . The data were fit to eight univariant , sigmoidal fluence – response curves ( R2 = 0.81–0.95 ) . The action spectrum constructed from these data fit an opsin template ( R2 = 0.91 ) , which identifies 446–477 nm as the most potent wavelength region providing circadian input for regulating melatonin secretion . The results suggest that , in humans , a single photopigment may be primarily responsible for melatonin suppression , and its peak absorbance appears to be distinct from that of rod and cone cell photopigments for vision . The data also suggest that this new photopigment is retinaldehyde based . These findings suggest that there is a novel opsin photopigment in the human eye that mediates circadian photoreception The circadian pacemaker is differentially sensitive to the re setting effects of retinal light exposure , depending upon the circadian phase at which the light exposure occurs . Previously reported human phase response curves ( PRCs ) to single bright light exposures have employed small sample sizes , and were often based on relatively imprecise estimates of circadian phase and phase re setting . In the present study , 21 healthy , entrained subjects underwent pre- and post-stimulus constant routines ( CRs ) in dim light ( approximately 2 - 7 lx ) with maintained wakefulness in a semi-recumbent posture . The 6.7 h bright light exposure stimulus consisted of alternating 6 min fixed gaze ( approximately 10 000 lx ) and free gaze ( approximately 5000 - 9000 lx ) exposures . Light exposures were scheduled across the circadian cycle in different subjects so as to derive a PRC . Plasma melatonin was used to determine the phase of the onset , offset , and midpoint of the melatonin profiles during the CRs . Phase shifts were calculated as the difference in phase between the pre- and post-stimulus CRs . The result ant PRC of the midpoint of the melatonin rhythm revealed a characteristic type 1 PRC with a significant peak-to-trough amplitude of 5.02 h. Phase delays occurred when the light stimulus was centred prior to the critical phase at the core body temperature minimum , phase advances occurred when the light stimulus was centred after the critical phase , and no phase shift occurred at the critical phase . During the subjective day , no prolonged ' dead zone ' of photic insensitivity was apparent . Phase shifts derived using the melatonin onsets showed larger magnitudes than those derived from the melatonin offsets . These data provide a comprehensive characterization of the human PRC under highly controlled laboratory conditions Light strongly influences the circadian timing system in humans via non-image-forming photoreceptors in the retinal ganglion cells . Their spectral sensitivity is highest in the short-wavelength range of the visible light spectrum as demonstrated by melatonin suppression , circadian phase shifting , acute physiological responses , and subjective alertness . We tested the impact of short wavelength light ( 460 nm ) on sleep EEG power spectra and sleep architecture . We hypothesized that its acute action on sleep is similar in magnitude to reported effects for polychromatic light at higher intensities and stronger than longer wavelength light ( 550 nm ) . The sleep EEGs of eight young men were analyzed after 2-h evening exposure to blue ( 460 nm ) and green ( 550 nm ) light of equal photon densities ( 2.8 x 10(13 ) photons x cm(-2 ) x s(-1 ) ) and to dark ( 0 lux ) under constant posture conditions . The time course of EEG slow-wave activity ( SWA ; 0.75 - 4.5 Hz ) across sleep cycles after blue light at 460 nm was changed such that SWA was slightly reduced in the first and significantly increased during the third sleep cycle in parietal and occipital brain regions . Moreover , blue light significantly shortened rapid eye movement ( REM ) sleep duration during these two sleep cycles . Thus the light effects on the dynamics of SWA and REM sleep duration s were blue shifted relative to the three-cone visual photopic system probably mediated by the circadian , non-image-forming visual system . Our results can be interpreted in terms of an induction of a circadian phase delay and /or repercussions of a stronger alerting effect after blue light , persisting into the sleep episode OBJECTIVE We examined the effects of an advanced sleep/wake schedule and morning short wavelength ( blue ) light in 25 adults ( mean age±SD=21.8±3 years ; 13 women ) with late sleep schedules and sub clinical features of delayed sleep phase disorder ( DSPD ) . METHODS After a baseline week , participants kept individualized , fixed , advanced 7.5-h sleep schedules for 6days . Participants were r and omly assigned to groups to receive " blue " ( 470 nm , ∼225lux , n=12 ) or " dim " ( < 1lux , n=13 ) light for 1h after waking each day . Head-worn " Daysimeters " measured light exposure ; actigraphs and sleep diaries confirmed schedule compliance . Salivary dim light melatonin onset ( DLMO ) , self-reported sleep , and mood were examined with 2 × 2 ANOVA . RESULTS After 6days , both groups showed significant circadian phase advances , but morning blue light was not associated with larger phase shifts than dim-light exposure . The average DLMO advances ( mean±SD ) were 1.5±1.1h in the dim light group and 1.4±0.7h in the blue light group . CONCLUSIONS Adherence to a fixed advanced sleep/wake schedule result ed in significant circadian phase shifts in young adults with sub clinical DSPD with or without morning blue light exposure . Light/dark exposures associated with fixed early sleep schedules are sufficient to advance circadian phase in young adults Ocular exposure to early morning room light can significantly advance the timing of the human circadian pacemaker . The re setting response to such light has a non-linear relationship to illuminance . The dose-response relationship of the human circadian pacemaker to late evening light of dim to moderate intensity has not been well established . Twenty-three healthy young male and female volunteers took part in a 9 day protocol in which a single experimental light exposure6.5 h in duration was given in the early biological night . The effects of the light exposure on the endogenous circadian phase of the melatonin rhythm and the acute effects of the light exposure on plasma melatonin concentration were calculated . We demonstrate that humans are highly responsive to the phase-delaying effects of light during the early biological night and that both the phase re setting response to light and the acute suppressive effects of light on plasma melatonin follow a logistic dose-response curve , as do many circadian responses to light in mammals . Contrary to expectations , we found that half of the maximal phase-delaying response achieved in response to a single episode of evening bright light ( approximately 9000 lux ( lx ) ) can be obtained with just over 1 % of this light ( dim room light of approximately 100 lx ) . The same held true for the acute suppressive effects of light on plasma melatonin concentrations . This indicates that even small changes in ordinary light exposure during the late evening hours can significantly affect both plasma melatonin concentrations and the entrained phase of the human circadian pacemaker The study investigated the effect of bright blue-enriched versus blue-suppressed indoor light on sleep and wellbeing of healthy participants over 65 years . Twenty-nine participants in 20 private houses in a uniform settlement in Copenhagen were exposed to two light epochs of 3 weeks with blue-enriched ( 280 lux ) and 3 weeks blue-suppressed ( 240 lux ) indoor light or vice versa from 8 to 13 pm in a r and omized cross-over design . The first light epoch was in October , the second in November and the two light epochs were separated by one week . Participants were examined at baseline and at the end of each light epoch . The experimental indoor light was well tolerated by the majority of the participants . Sleep duration was 7.44 ( 95 % CI 7.14–7.74 ) hours during blue-enriched conditions and 7.31 ( 95 % CI 7.01–7.62 ) hours during blue-suppressed conditions ( p = 0.289 ) . Neither rest hours , chromatic pupillometry , nor saliva melatonin profile showed significant changes between blue-enriched and blue-suppressed epochs . Baseline Pittsburgh Sleep Quality Index ( PSQI ) was significantly worse in females ; 7.62 ( 95 % CI 5.13–10.0 ) versus 4.06 ( 95 % CI 2.64–5.49 ) in males , p = 0.009 . For females , PSQI improved significantly during blue-enriched light exposure ( p = 0.007 ) ; no significant changes were found for males . The subjective grading of indoor light quality doubled from participants habitual indoor light to the bright experimental light , while it was stable between light epochs , although there were clear differences between blue-enriched and blue-suppressed electrical light conditions imposed . Even though the study was carried out in the late autumn at northern latitude , the only significant difference in Actiwatch-measured total blue light exposure was from 8 to 9 am , because contributions from blue-enriched , bright indoor light were superseded by contributions from daylight Significance The use of light-emitting electronic devices for reading , communication , and entertainment has greatly increased recently . We found that the use of these devices before bedtime prolongs the time it takes to fall asleep , delays the circadian clock , suppresses levels of the sleep-promoting hormone melatonin , reduces the amount and delays the timing of REM sleep , and reduces alertness the following morning . Use of light-emitting devices immediately before bedtime also increases alertness at that time , which may lead users to delay bedtime at home . Overall , we found that the use of portable light-emitting devices immediately before bedtime has biological effects that may perpetuate sleep deficiency and disrupt circadian rhythms , both of which can have adverse impacts on performance , health , and safety . In the past 50 y , there has been a decline in average sleep duration and quality , with adverse consequences on general health . A representative survey of 1,508 American adults recently revealed that 90 % of Americans used some type of electronics at least a few nights per week within 1 h before bedtime . Mounting evidence from countries around the world shows the negative impact of such technology use on sleep . This negative impact on sleep may be due to the short-wavelength – enriched light emitted by these electronic devices , given that artificial-light exposure has been shown experimentally to produce alerting effects , suppress melatonin , and phase-shift the biological clock . A few reports have shown that these devices suppress melatonin levels , but little is known about the effects on circadian phase or the following sleep episode , exposing a substantial gap in our knowledge of how this increasingly popular technology affects sleep . Here we compare the biological effects of reading an electronic book on a light-emitting device ( LE-eBook ) with reading a printed book in the hours before bedtime . Participants reading an LE-eBook took longer to fall asleep and had reduced evening sleepiness , reduced melatonin secretion , later timing of their circadian clock , and reduced next-morning alertness than when reading a printed book . These results demonstrate that evening exposure to an LE-eBook phase-delays the circadian clock , acutely suppresses melatonin , and has important implication s for underst and ing the impact of such technologies on sleep , performance , health , and safety Background Light exposure can cascade numerous effects on the human circadian process via the non-imaging forming system , whose spectral relevance is highest in the short-wavelength range . Here we investigated if commercially available compact fluorescent lamps with different colour temperatures can impact on alertness and cognitive performance . Methods Sixteen healthy young men were studied in a balanced cross-over design with light exposure of 3 different light setting s ( compact fluorescent lamps with light of 40 lux at 6500 K and at 2500 K and inc and escent lamps of 40 lux at 3000 K ) during 2 h in the evening . Results Exposure to light at 6500 K induced greater melatonin suppression , together with enhanced subjective alertness , well-being and visual comfort . With respect to cognitive performance , light at 6500 K led to significantly faster reaction times in tasks associated with sustained attention ( Psychomotor Vigilance and GO/NOGO Task ) , but not in tasks associated with executive function ( Paced Visual Serial Addition Task ) . This cognitive improvement was strongly related with attenuated salivary melatonin levels , particularly for the light condition at 6500 K . Conclusions Our findings suggest that the sensitivity of the human alerting and cognitive response to polychromatic light at levels as low as 40 lux , is blue-shifted relative to the three-cone visual photopic system . Thus , the selection of commercially available compact fluorescent lights with different colour temperatures significantly impacts on circadian physiology and cognitive performance at home and in the workplace Light in the short wavelength range
Output:
| The melatonin concentration recovered rather rapidly , within 15 min from cessation of the exposure , suggesting a short-term or simultaneous impact of light exposure on the melatonin secretion .
Melatonin secretion and suppression were reduced with age , but the light-induced circadian phase advance was not impaired with age .
Light exposure in the evening , at night and in the morning affected the circadian phase of melatonin levels .
In addition , even the longest wavelengths ( 631 nm , red ) and intermittent light exposures induced circadian re setting responses , and exposure to low light levels ( 5 - 10 lux ) at night when sleeping with eyes closed induced a circadian response . |
MS211497 | ***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 research and development costs of 68 r and omly selected new drugs were obtained from a survey of 10 pharmaceutical firms . These data were used to estimate the average pre-tax cost of new drug development . The costs of compounds ab and oned during testing were linked to the costs of compounds that obtained marketing approval . The estimated average out-of-pocket cost per new drug is 403 million US dollars ( 2000 dollars ) . Capitalizing out-of-pocket costs to the point of marketing approval at a real discount rate of 11 % yields a total pre-approval cost estimate of 802 million US dollars ( 2000 dollars ) . When compared to the results of an earlier study with a similar methodology , total capitalized costs were shown to have increased at an annual rate of 7.4 % above general price inflation Background . Acupuncture might have effectiveness in relieving the symptoms of chronic urticaria . There are currently no systematic review s of acupuncture for chronic urticaria published in English . Objective . We conducted a systematic review to assess the effectiveness and safety of acupuncture for chronic urticaria . Methods . A systematic review and meta- analysis of r and omized , controlled trials were performed . The primary outcome was global symptom improvement . Results . We included 6 studies with 406 participants . Three trials showed significant difference between acupuncture and drugs in global symptom improvement ( relative risk 1.37 ; 95 % CI 1.11–1.70 ; P = 0.003 ) . As an adjuvant to medication , acupuncture was also beneficial for global symptom improvement ( relative risk 1.77 ; 95 % CI 1.41–2.22 ; P < 0.01 ) . There were no severe adverse events related to acupuncture . Limitations . Some method ological limitations were observed . The overall risk of bias in the 6 included trials was high and all included RCTs were conducted in China and published in Chinese . Besides , the lack of proper control groups and the use of different rating methods and cut-offs in the included trials also made the evidence of this review limited . Conclusions . Acupuncture might be effective and safe for chronic urticaria in relieving symptoms , based on a low level of evidence . To draw a reliable conclusion , more high quality trials are needed in the future . This trial is registered with PROSPERO CRD42015015702 OBJECTIVE Our purpose was to measure the agreement , reliability , construct validity , and feasibility of a measurement tool to assess systematic review s ( AMSTAR ) . STUDY DESIGN AND SETTING We r and omly selected 30 systematic review s from a data base . Each was assessed by two review ers using : ( 1 ) the enhanced quality assessment question naire ( Overview of Quality Assessment Question naire [ OQAQ ] ) ; ( 2 ) Sacks ' instrument ; and ( 3 ) our newly developed measurement tool ( AMSTAR ) . We report on reliability ( interobserver kappas of the 11 AMSTAR items ) , intraclass correlation coefficients ( ICCs ) of the sum scores , construct validity ( ICCs of the sum scores of AMSTAR compared with those of other instruments ) , and completion times . RESULTS The interrater agreement of the individual items of AMSTAR was substantial with a mean kappa of 0.70 ( 95 % confidence interval [ CI ] : 0.57 , 0.83 ) ( range : 0.38 - 1.0 ) . Kappas recorded for the other instruments were 0.63 ( 95 % CI : 0.38 , 0.78 ) for enhanced OQAQ and 0.40 ( 95 % CI : 0.29 , 0.50 ) for the Sacks ' instrument . The ICC of the total score for AMSTAR was 0.84 ( 95 % CI : 0.65 , 0.92 ) compared with 0.91 ( 95 % CI : 0.82 , 0.96 ) for OQAQ and 0.86 ( 95 % CI : 0.71 , 0.94 ) for the Sacks ' instrument . AMSTAR proved easy to apply , each review taking about 15 minutes to complete . CONCLUSIONS AMSTAR has good agreement , reliability , construct validity , and feasibility . These findings need confirmation by a broader range of assessors and a more diverse range of review Objectives To examine the evidence derived from r and omized controlled clinical trials on the efficacy and safety of omalizumab compared to placebo in controlling symptoms of chronic idiopathic urticaria/chronic spontaneous urticaria ( CIU/CSU ) . Data source The electronic data bases PubMed , Medline , EMBASE , Biomed Central , The Cochrane Central Register of Controlled Trials ( CENTRAL ) , Wiley , OVID , and HighwirePress were review ed . The date limit was set to May 31th , but it was extended to September 30th of 2014 due to a new publication . No language restriction was used . The articles included were r and omized trials controlled with placebo in individuals older than 12 years diagnosed with CIU/CSU refractory to conventional treatment , the intervention being , omalizumab at different doses , and the comparison , placebo . The primary outcome was symptom improvement according to the weekly score of urticaria severity ( UAS7 ) , the itch severity score ( ISS ) , the weekly score of number of urticarial lesions , the dermatology life quality index , and the chronic urticaria quality of life question naire ( CU-QoL ) . Data bases were search ed using the following Mesh or EMTREE key words including as intervention “ omalizumab ” or “ humanized monoclonal antibody , ” compared to placebo and the disease of interest “ urticaria ” or “ angioedema ” . The title , abstract and article were review ed by two independent investigators , according to the selection criteria in each of the data bases . An assessment of the quality of the articles was performed according to the bias tool from the studies of the Cochrane Collaboration . Information such as author data , date of study , number of participants , interventions , dose and frequency of administration , comparison , time of follow-up , measurements of weekly score of urticaria activity , pruritus severity score , weekly urticarial lesions , percentage of angioedema and post-treatment change were extracted . Frequency of adverse events and the ones suspected to be caused by the intervention drug were included . Results 770 records were identified in all data bases described . 720 were eliminated for failing to meet the inclusion criteria in the first review or for duplicate records . 24 articles were review ed by abstract , 18 additional articles were further removed , leaving 6 records for inclusion . An experimental study was excluded because it was n’t r and omized . Five studies were finally included , with 1117 patients , of these 831 received a dose of omalizumab of 75 mg ( 183 patients , 16.38 % ) , 150 mg ( 163 patients , 14.59 % ) , 300 mg ( 437 patients , 39.12 % ) or 600 mg ( 21 patients , 1.8 % ) , as a single dose , or every 4 weeks until 24 weeks maximum . The average age was 42.07 years , predominantly female gender and white ethnicity . It was observed that the use of omalizumab 300 mg lowered the weekly scores of urticarial activity in 19.9 vs. 6.9 on placebo ( p < 0.01 ) , 19 vs 8.5 and 20.7 vs 8.01 in three studies , the weekly ISS ( −9.2 vs. - 3.5 , p < 0.001 , −9.8 vs −5.1 p < 0.01 , −8.6 vs −4.0 and −9.4 vs −3.63 p < 0.001 in four studies ) , and the percentage of angioedema-free days ( omalizumab 95.5 % vs. placebo 89.2 % p < 0.001 , and 91.95 % vs. 88.1 % p < 0.001 in two of the studies respectively ) . Limitations The different doses used throughout the study , time of administration and follow-up periods ranged from single dose to monthly dose for 24 weeks . Therefore no meta- analysis of the review was conducted . Conclusions and implication s of the main findings Despite the limitations , it is considered that omalizumab 300 mg is effective in treating chronic idiopathic urticaria refractory to H1 antihistamines . Further studies are required to determine the duration of effective treatment . Registration number of the systematic review http://www.crd.york.ac.uk/ PROSPERO /display_record.asp?ID = CRD42014010029#.VJDr1vl5PpM ( PROSPERO . International Prospect i ve Register of Systematic Review s ) Aims : With the increase in the number of systematic review s available , a logical next step to provide decision makers in healthcare with the evidence they require has been the conduct of review s of existing systematic review s. Syntheses of existing systematic review s are referred to by many different names , one of which is an umbrella review . An umbrella review allows the findings of review s relevant to a review question to be compared and contrasted . An umbrella review 's most characteristic feature is that this type of evidence synthesis only considers for inclusion the highest level of evidence , namely other systematic review s and meta-analyses . A methodology working group was formed by the Joanna Briggs Institute to develop method ological guidance for the conduct of an umbrella review , including diverse types of evidence , both quantitative and qualitative . The aim of this study is to describe the development and guidance for the conduct of an umbrella review . Methods : Discussion and testing of the elements of methods for the conduct of an umbrella review were held over a 6-month period by members of a methodology working group . The working group comprised six participants who corresponded via teleconference , e-mail and face-to-face meeting during this development period . In October 2013 , the methodology was presented in a workshop at the Joanna Briggs Institute Convention . Workshop participants , review authors and method ologists provided further testing , critique and feedback on the proposed methodology . Results : This study describes the methodology and methods developed for the conduct of an umbrella review that includes published systematic review s and meta-analyses as the analytical unit of the review . Details are provided regarding the essential elements of an umbrella review , including presentation of the review question in a Population , Intervention , Comparator , Outcome format , nuances of the inclusion criteria and search strategy . A critical appraisal tool with 10 questions to help assess risk of bias in systematic review s and meta-analyses was also developed and tested . Relevant details to extract from included review s and how to best present the findings of both quantitative and qualitative systematic review s in a reader friendly format are provided . Conclusions : Umbrella review s provide a ready means for decision makers in healthcare to gain a clear underst and ing of a broad topic area . The umbrella review methodology described here is the first to consider review s that report other than quantitative evidence derived from r and omized controlled trials . The methodology includes an easy to use and informative summary of evidence table to readily provide decision makers with the available , highest level of evidence relevant to the question posed The effect of 60 mg twice-daily fexofenadine HCl on health-related quality of life and productivity at work , in the classroom , and during daily activities in patients with moderate to severe chronic idiopathic urticaria symptoms was studied in two identical , 4-week , placebo-controlled , multicenter clinical trials . Patients self-administered the Dermatology Life Quality Index ( score , 0 - 30 ) and the Work Productivity and Activity Impairment instrument ( 0%-100 % ) . In both trials , improvements in Dermatology Life Quality Index scores in fexofenadine-treated patients ( N = 169 ) were statistically significant compared with placebo ( P < or = .0002 ) . Similarly , improvements in productivity scores with fexofenadine 60 mg twice daily were statistically superior to placebo at work ( n = 120 , P < or = .0152 ) and in performance of daily activities ( n = 166 , P < or = .0002 ) . There was a trend toward improved classroom productivity ( n = 26 ) with fexofenadine . We conclude fexofenadine 60 mg twice daily improves health-related quality of life , increases work productivity , and improves performance of daily activities in patients with moderate to severe chronic idiopathic urticaria INTRODUCTION Chronic Urticaria is a difficult to define condition from the nosographic st and point , with complex pharmacological management , that heavily impacts the life of the patient . Some forms show not to be responsive to anti H1 anti-histaminic and require other treatments . One of these can be the treatment with Cyclosporine A ( CsA ) . MATERIAL S AND METHODS This study , open and sequential , reports the results of short-term treatment over a sample of adults ( 21 patients ) of both sexes , all suffering from chronic urticaria with IgE levels higher than 200 mU/ml treated with 4 mg/kg/die of CsA. RESULTS The results obtained show a reduction in the levels of total IgE and a significant improvement in symptoms ; there were no adverse effects . CONCLUSIONS Cyclosporine is an excellent treatment for chronic urticaria because it reduces the activity of T lymphocytes and reduction of the histamine release from the mast cells and basophils Background : Omalizumab , a recombinant anti‐IgE antibody , effectively treats chronic spontaneous urticaria . Evidence is lacking in patients with chronic inducible urticarias ( CInd
Output:
| There is some evidence to support a variety of interventions for CU .
Moreover , there remained little information on the relative effectiveness of one intervention compared with another . |
MS211498 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
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Input: OBJECTIVES To conduct a r and omized controlled trial to evaluate the cost effectiveness of a lay health worker-administered cervical cancer screening intervention for Vietnamese-American women . METHODS The study group included 234 Vietnamese women in the Seattle , Washington area who had not received a Pap test in the last three years . Experimental group participants received a lay health worker home visit . The travel distance and time spent at each visit were recorded . Our trial end-point was Pap smear receipt within six months of r and omization . Pap testing completion was ascertained through medical record review s. RESULTS For all Vietnamese women , regardless of their prior history of screening , the cost per intervention was $ 104.0 ( 95 % CI : $ 89.6-$118.4 ) . The change in quality -adjusted life days per intervention was 1.26 ( 95 % CI : -5.43 - 7.96 ) , result ing in an incremental cost-effectiveness ratio ( ICER ) of $ 30,015 per quality -adjusted life year . The probability that the ICER exceeds $ 100,000 is 9.1 % . CONCLUSIONS The degree of cost effectiveness of such interventions is sensitive to the assumed duration of behavioral change and the participants ' prior history of screening Abstract BACKGROUND : R and omized controlled trials have demonstrated that fecal occult blood testing ( FOBT ) reduces colorectal cancer ( CRC ) mortality . However , patient compliance with FOBT is low and this is one of the major barriers to CRC screening . OBJECTIVE : To determine whether intensive patient education increases FOBT card return rates . DESIGN : R and omized controlled trial . SETTING : Department of Veterans Affairs primary care clinic . PARTICIPANTS : Seven hundred eighty-eight patients who were referred for FOBT . INTERVENTIONS : Patients were r and omly allocated to receive either intensive ( n=396 ) or st and ard ( n=392 ) patient education . Patients in the intensive education group received a one-on-one educational session by primary care nurses on the importance of CRC screening , were instructed on how to properly collect stool specimens for FOBT , and were given a 2-page h and out on CRC screening . Patients in the st and ard education group only received the FOBT cards and written instructions from the manufacturer on how to properly collect stool specimens for FOBT . RESULTS : Patients in the intensive education group were more likely to return the FOBT cards ( 65.9 % vs 51.3 % ; P<.001 ) and called the clinic with additional questions less often ( 1.5 % vs 5.9 % ; P=.001 ) than the st and ard education group . The median time to return the FOBT cards was significantly shorter in the intensive education group ( 36 vs 143 days ; P<.001 by log-rank test ) . However , the proportion of patients who had a positive FOBT did not differ in the two groups ( 4.6 % vs 6.0 % ; P=.51 ) . CONCLUSIONS : Intensive patient education significantly improved patient compliance with FOBT . Future studies to evaluate additional educational strategies to further improve patient compliance with CRC screening are warranted Objectives Screening for colorectal cancer is considered cost effective , but is underutilized in the U.S. Information on the efficiency of " tailored interventions " to promote colorectal cancer screening in primary care setting s is limited . The paper reports the results of a cost effectiveness analysis that compared a survey-only control group to a Centers for Disease Control ( CDC ) web-based intervention ( screen for life ) and to a tailored interactive computer-based intervention . Methods A r and omized controlled trial of people 50 and over , was conducted to test the interventions . The sample was 1224 partcipants 50 - 70 years of age , recruited from Kelsey-Seybold Clinic , a large multi-specialty clinic in Houston , Texas . Screening status was obtained by medical chart review after a 12-month follow-up period . An " intention to treat " analysis and micro costing from the patient and provider perspectives were used to estimate the costs and effects . Analysis of statistical uncertainty was conducted using nonparametric bootstrapping . Results The estimated cost of implementing the web-based intervention was $ 40 per person and the cost of the tailored intervention was $ 45 per person . The additional cost per person screened for the web-based intervention compared to no intervention was $ 2602 and the tailored intervention was no more effective than the web-based strategy . Conclusions The tailored intervention was less cost-effective than the web-based intervention for colorectal cancer screening promotion . The web-based intervention was less cost-effective than previous studies of in-reach colorectal cancer screening promotion . Research ers need to continue developing and evaluating the effectiveness and cost-effectiveness of interventions to increase colorectal cancer screening Background . Colorectal cancer is the second leading cause of cancer-related death in the United States . Despite universal screening recommendations , screening rates in the United States remain suboptimal , especially among the poor , the uninsured , recent immigrants , and Hispanics . This article describes the development of a large community-based colorectal cancer screening program design ed to address these disparities . Method . The Against Colorectal Cancer in our Neighborhoods program is a bilingual , evidence -based , theory-guided , multicomponent community screening intervention , targeting the uninsured and developed using a systematic planning process . It combines community health worker – led outreach , bilingual and culturally tailored community education , and no-cost screening with provision of the fecal immunochemical test or colonoscopy and navigation services . A detailed process and outcome evaluation is planned . Program development cost calculated prospect ively ( in 2011 dollars ) using a societal perspective and micro-costing methods was $ 243,278 , of which $ 180,344 was direct cost . Discussion . The detailed description of the development processes and costs of this health promotion program targeting low-income Hispanics will inform health program decision makers about the re source requirements for planning and developing new programs to reduce disease burden in communities Background Sending faecal occult blood tests ( FOBT ) by mail has been proposed both as a method to increase participation and a way to reduce staff costs in colorectal cancer screening . Methods Two multicentre r and omized controlled trials ( IS RCT N10351276 ) were performed : one r and omly assigned 3196 individuals who had previously participated in colorectal screening to receive a FOBT kit at home or a st and ard invitation ; in the second , 4219 people aged 50–69 years who did not respond to a screening invitation were either sent a FOBT or a st and ard recall letter . The cost per returned kit was calculated in each arm . Results Participation was higher with direct FOBT mailing in both trials : relative risk 1.11 ( 95 % CI 1.06–1.17 ) and 1.36 ( 95 % CI 1.16–1.60 ) for previous responders and non-responders , respectively . The cost per returned kit for previous responders ranged from 4.24 € to 16.10 € , and from 3.29 € to 7.36 € with FOBT mailing and st and ard invitation , respectively , not including staff costs ; for non-responders it ranged from 17.13 € to 46.80 € , and from 7.36 € to 18.30 € with FOBT mailing and st and ard recall , respectively . Conclusions The FOBT mailing strategy modestly increased participation . This method can be used on a population of previous responders to reduce personnel costs and workload . When used as a reminder to non-responders , this method increases costs PURPOSE Colorectal cancer screening is underused , particularly in the Veterans Affairs ( VA ) population . In a r and omized controlled trial , a health care provider-directed intervention that offered quarterly feedback to physicians on their patients ' colorectal cancer screening rates led to a 9 % increase in colorectal cancer screening rates among veterans . The objective of this secondary analysis was to assess the cost effectiveness of the colorectal cancer screening promotion intervention . METHODS Providers in the intervention arm attended an educational workshop on colorectal cancer screening and received confidential feedback on individual and group-specific colorectal cancer screening rates . The primary end point was completion of colorectal cancer screening tests . Sensitivity analyses investigated cost-effectiveness estimates varying the data collection methods , costs of labor and technology , and the effectiveness of the intervention . RESULTS Rates of colorectal cancer screening for the intervention versus control arms were 41.3 % v 32.4 % , respectively ( P < .05 ) . The incremental cost-effectiveness ratio was dollar 978 per additional veteran screened based on feedback reports generated from manual review of records . However , if feedback reports could be generated from information technology systems , sensitivity analyses indicate that the cost-effectiveness estimate would decrease to dollar 196 per additional veteran screened . CONCLUSION An intervention based on quarterly feedback reports to physicians improved colorectal cancer screening rates at a VA medical center . This intervention would be cost effective if relevant data could be generated by existing information technology systems . Our findings may have broad applicability because a 2005 Medicare initiative will provide the VA electronic medical record system as a free benefit to all US physicians Purpose : Low-cost interventions to improve cancer screening among primary care patients are needed . The comparative effectiveness of personalized letters , automated telephone calls , and both on breast cancer ( BC ) and colorectal cancer ( CRC ) screening is not known . Methods : A pragmatic , r and omized , controlled trial was conducted in 2011 to 2012 . Eligible primary care patients were women ages 50 to 74 years who were past due for mammography and men or women who were past due for mammography or CRC screening of any kind ( > 12 months since last fecal occult blood test , > 5 years since last sigmoidoscopy/double-contrast barium enema , or > 10 years since last colonoscopy ) , respectively . Participants were r and omized to 1 of 3 interventions : personalized mailed letters , automated telephone calls , or both . The primary outcome was medical record documentation of a completed mammogram or CRC screening within 36 weeks of r and omization . We estimated the costs of each intervention and calculated the marginal cost-effectiveness per person screened . Results : The crude screening rates for BC were 19 % , 22 % , and 37 % and for CRC were 17 % , 14 % , and 24 % for the letter , automated call , and combined ( letter/automated call ) groups , respectively . The combined intervention group had a statistically higher screening rate ( P < .05 ) compared with either of the single intervention groups ( letter only or automated call ) for both BC and CRC in both the crude and adjusted analyses . The combined intervention costs $ 5.11 per additional person screened for BC and $ 13.14 per additional person screened for CRC . Conclusion : In a primary care practice , letters plus automated telephone calls are better than either alone in increasing cancer screening rates among patients who are overdue for screening . These findings suggest the promise of a relatively inexpensive intervention to improve cancer screening Background Colorectal cancer ( CRC ) screening rates are low in many areas and cost-effective interventions to promote CRC screening are needed . Recently in a r and omized controlled trial , a mailed educational reminder increased CRC screening rates by 16.2 % among U.S. Veterans . The aim of our study was to assess the costs and cost-effectiveness of a mailed educational reminder on fecal occult blood test ( FOBT ) adherence . Methods In a blinded , r and omized , controlled trial , 769 patients were r and omly assigned to the usual care group ( FOBT alone , n = 382 ) or the intervention group ( FOBT plus a mailed reminder , n = 387 ) . Ten days after picking up the FOBT cards , a 1-page reminder with information related to CRC screening was mailed to the intervention group . Primary outcome was number of returned FOBT cards after 6 months . The costs and incremental cost-effectiveness ratio ( ICER ) of the intervention were assessed and calculated respectively . Sensitivity analyses were based on varying costs of labor and supplies . Results At 6 months after card distribution , 64.6 % patients in the intervention group returned FOBT cards compared with 48.4 % in the control group ( P < 0.001 ) . The total cost of the intervention was $ 962 or $ 2.49 per patient , and the ICER was $ 15 per additional person screened for CRC . Sensitivity analysis based on a 10 % cost variation was $ 13.50 to $ 16.50 per additional patient screened for CRC . Conclusions A simple mailed educational reminder increases FOBT card return rate at a cost many health care systems can afford . Compared to other patient-directed interventions ( telephone , letters from physicians , mailed reminders ) for CRC screening , our intervention was more effective and cost-effective Purpose The purpose of this study was to evaluate the cost effectiveness of colorectal cancer screening interventions with their effects on health disparity being considered . Material s and Methods Markov cohort simulation was conducted with the cycle/ duration of 1/40 year(s ) . Data came from the results of r and omized trials and others . Participants were hypothetical cohorts aged 50 years as of year 2013 in 16 Korean provinces . The interventions until the age of 80 were annual organized fecal occult blood test ( FOBT ) ( st and ard screening ) , annual FOBT with basic reminders for provinces with higher mortalities than the national average ( targeted reminder )
Output:
| Multicomponent interventions to increase cervical and colorectal cancer screening were cost effective based on a very conservative threshold .
Additionally , multicomponent interventions for colorectal cancer screening demonstrated net cost savings . |
MS211499 | ***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 Trigger points have been shown to be active in many myofascial pain syndromes . Treatment of trigger point pain and dysfunction may be explained through the mechanisms of central and peripheral paradigms . This study aim ed to investigate whether the mind/body treatment of Neuro Emotional Technique ( NET ) could significantly relieve pain sensitivity of trigger points presenting in a cohort of chronic neck pain sufferers . Methods Sixty participants presenting to a private chiropractic clinic with chronic cervical pain as their primary complaint were sequentially allocated into treatment and control groups . Participants in the treatment group received a short course of Neuro Emotional Technique that consists of muscle testing , general semantics and Traditional Chinese Medicine . The control group received a sham NET protocol . Outcome measurements included pain assessment utilizing a visual analog scale and a pressure gauge algometer . Pain sensitivity was measured at four trigger point locations : suboccipital region ( S ) ; levator scapulae region ( LS ) ; sternocleidomastoid region ( SCM ) and temporom and ibular region ( TMJ ) . For each outcome measurement and each trigger point , we calculated the change in measurement between pre- and post- treatment . We then examined the relationships between these measurement changes and six independent variables ( i.e. treatment group and the above five additional participant variables ) using forward stepwise General Linear Model . Results The visual analog scale ( 0 to 10 ) had an improvement of 7.6 at S , 7.2 at LS , 7.5 at SCM and 7.1 at the TMJ in the treatment group compared with no improvement of at S , and an improvement of 0.04 at LS , 0.1 at SCM and 0.1 at the TMJ point in the control group , ( P < 0.001 ) . Conclusion After a short course of NET treatment , measurements of visual analog scale and pressure algometer recordings of four trigger point locations in a cohort of chronic neck pain sufferers were significantly improved when compared to a control group which received a sham protocol of NET . Chronic neck pain sufferers may benefit from NET treatment in the relief of trigger point sensitivity . Further research including long-term r and omised controlled trials for the effect of NET on chronic neck pain , and other chronic pain syndromes are recommended . Trial Registration This trial has been registered and allocated the Australian Clinical Trials Registry ( ACTR ) number ACTRN012607000358448 . The ACTR has met the requirements of the ICMJE 's trials registration policy and is an ICMJE acceptable registry Background This pilot r and omized controlled trial evaluated the feasibility of conducting a full scale study and compared the efficacy of exercise , spinal manipulation , and a mind-body therapy called Neuro Emotional Technique for the treatment of pregnancy-related low back pain , a common morbidity of pregnancy . Methods Healthy pregnant women with low back pain of insidious onset were eligible to enroll in the study at any point in their pregnancy . Once enrolled , they remained in the study until they had their babies . Women were r and omly allocated into one of three treatment groups using opaque envelopes . The treatment schedule paralleled the prenatal care schedule and women received individualized intervention . Our null hypothesis was that spinal manipulation and Neuro Emotional Technique would perform no better than exercise in enhancing function and decreasing pain . Our primary outcome measure was the Rol and Morris Disability Question naire and our secondary outcome measure was the Numeric Pain Rating Scale . Intention to treat analysis was conducted . For the primary analysis , regression was conducted to compare groups on the outcome measure scores . In a secondary responder analysis , difference in proportions of participants in attaining 30 % and 50 % improvement were calculated . Feasibility factors for conducting a future larger trial were also evaluated such as recruitment , compliance to study protocol s , cost , and adverse events . Results Fifty-seven participants were r and omized into the exercise ( n = 22 ) , spinal manipulation ( n = 15 ) , and Neuro Emotional Technique ( n = 20 ) treatment arms . At least 50 % of participants in each treatment group experienced clinical ly meaningful improvement in symptoms for the Rol and Morris Disability Question naire . At least 50 % of the exercise and spinal manipulation participants also experienced clinical ly meaningful improvement for the Numeric Pain Rating Scale . There were no clinical ly meaningful or statistically significant differences between groups in any analysis . Conclusions This pilot study demonstrated feasibility for recruitment , compliance , safety , and affordability for conducting a larger study in the future . Spinal manipulation and exercise generally performed slightly better than did Neuro Emotional Technique for improving function and decreasing pain , but the study was not powered to detect the between-group differences as statistically significant . Trial registration Clinical Trials.gov ( Identifier : NCT00937365 ) OBJECTIVE Pregnancy-related lumbopelvic pain is a major problem for the majority of pregnant women . Complementary medicine has been used to alleviate pain , and yoga is one of the most commonly chosen alternative methods . The objective of this study was to assess the effectiveness of Hatha yoga in the reduction of lumbopelvic pain in pregnancy . METHODS A r and omized controlled trial with 60 pregnant women ( age range , 14 - 40 years ) who reported lumbopelvic pain at 12 to 32 weeks of gestation was conducted from June 2009 to June 2011 . Pregnant women who had twin pregnancies , had medical restrictions for exercise , used analgesics , and participated in physical therapy were excluded from the study . Pregnant women were divided into two groups : the yoga group , practicing exercises guided by this method , and the postural orientation group , performing st and ardized posture orientation according to instructions provided in a pamphlet . Treatment in each group lasted 10 weeks . A visual analog scale ( VAS ) was used to measure pain intensity . Lumbar pain and posterior pelvic pain provocation tests were used to confirm the presence of pain . Statistical analysis included the Mann-Whitney test , the McNemar test , a paired Wilcoxon test , and analysis of covariance . RESULTS The median pain score was lower in the yoga group ( p<.0058 ) than the postural orientation group . Lumbar pain provocation tests showed a decreased response in relation to posterior pelvic pain provocation tests and a gradual reduction in pain intensity during 10 yoga sessions ( p<.024 ) . CONCLUSIONS The yoga method was more effective at reducing lumbopelvic pain intensity compared with postural orientation Background Both maternal pre-pregnancy obesity and excessive gestational weight gain are increasing in prevalence and associated with a number of adverse pregnancy outcomes for both mother and child . Observational studies regarding physical activity in pregnancy have found reduced weight gain in active mothers , as well as reduced risk of adverse pregnancy outcomes . There is however a lack of high quality , r and omized controlled trials on the effects of regular exercise training in pregnancy , especially those with a pre-pregnancy body mass index ( BMI ) at or above 30 kg/m2 . Methods We are conducting a r and omised , controlled trial in Norway with two parallel arms ; one intervention group and one control group . We will enroll 150 previously sedentary , pregnant women with a pre-pregnancy BMI at or above 30 kg/m2 . The intervention group will meet for organized exercise training three times per week , starting in gestation week 14 ( range 12 - 16 ) . The control group will get st and ard antenatal care . The main outcome measure will be weight gain from baseline to delivery . Among the secondary outcome measures are changes in exercise capacity , endothelial function , physical activity level , body composition , serum markers of cardiovascular risk , incontinence , lumbopelvic pain and cardiac function from baseline to gestation week 37 ( range 36 - 38 ) . Offspring outcome measures include anthropometric variables at birth , Apgar score , as well as serum markers of inflammation and metabolism in cord blood . Discussion The results of this trial will provide knowledge about effects of regular exercise training in previously sedentary , obese pregnant women . If the program proves effective in reducing gestational weight gain and adverse pregnancy outcomes , such programs should be considered as part of routine pregnancy care for obese women . Trial Registration Clinical Trials.gov : Background Previous publications indicate that acupuncture is efficient for the treatment of pelvic girdle pain , PGP , in pregnant women . However , the use of acupuncture for PGP is rare due to insufficient documentation of adverse effects of this treatment in this specific condition . The aim of the present work was to assess adverse effects of acupuncture on the pregnancy , mother , delivery and the fetus/neonate in comparison with women that received stabilising exercises as adjunct to st and ard treatment or st and ard treatment alone . Methods In all , 386 women with PGP entered this controlled , single-blind trial . They were r and omly assigned to st and ard treatment plus acupuncture ( n = 125 ) , st and ard treatment plus specific stabilising exercises ( n = 131 ) or to st and ard treatment alone ( n = 130 ) for 6 weeks . Acupuncture that may be considered strong was used and treatment was started as early as in the second trimester of pregnancy . Adverse effects were recorded during treatment and throughout the pregnancy . Influence on the fetus was measured with cardiotocography ( CTG ) before-during and after 43 acupuncture sessions in 43 women . A st and ardised computerized method to analyze the CTG reading numerically ( Oxford 8000 , Oxford , Engl and ) was used . After treatment , the women rated their overall experience of the treatment and listed adverse events if any in a question naire . Data of analgesia and oxytocin augmentation during labour , duration of labour , frequency of preterm birth , operative delivery , Apgar score , cord-blood gas/acid base balance and birth weight were also recorded . Results There were no serious adverse events after any of the treatments . Minor adverse events were common in the acupuncture group but women rated acupuncture favourably even despite this . The computerized or visually assessed CTG analyses of antenatal recordings in connection with acupuncture were all normal . Conclusion This study shows that acupuncture administered with a stimulation that may be considered strong led to minor adverse complaints from the mothers but had no observable severe adverse influences on the pregnancy , mother , delivery or the fetus/neonate Background : To compare the efficiency of transcutaneous electrical nerve stimulation ( TENS ) with those of exercise and acetaminophen for the treatment of pregnancy-related low back pain ( LBP ) during the third trimester of pregnancy . Methods : This prospect i ve study included 79 subjects ( ≥32 gestational weeks ) with visual analog scale ( VAS ) pain scores ≥5 . Participants were divided r and omly into a control group ( n = 21 ) and three treatment groups [ exercise ( n = 19 ) ; acetaminophen ( n = 19 ) ; TENS ( n = 20 ) ] . The VAS and the Rol and -Morris disability question naire ( RMDQ ) were completed before and 3 weeks after treatment to assess the impact of pain on daily activities . Results : During the study period , pain intensity increased in 57 % of participants in the control group , whereas pain decreased in 95 % of participants in the exercise group and in all participants in the acetaminophen and TENS groups . Post-treatment VAS and RMDQ values were significantly lower in the treatment groups ( p < 0.001 ) . VAS and RMDQ scores indicated a significantly greater degree of pain relief in the TENS group than in the exercise and acetaminophen groups ( p < 0.001 ) . No adverse effect of TENS application on pregnant women was observed during the study . Conclusion : TENS is an effective and safe treatment modality for LBP during pregnancy . TENS improved LBP more effectively than did exercise and acetaminophen Background . Low back and pelvic pain is common in pregnancy and postpartum , but there is no well documented effect of treatment in pregnancy . The aim of the study was to assess whether a group intervention program for pregnant women with pelvic girdle pain has any effect on pain and daily function postpartum . Methods . Pregnant women with pelvic pain between the 18th and 32nd week of gestation were invited to participate in a r and omized clinical study . Among 958 examined women , 569 ( 59 % ) fulfilled the inclusion criteria . Women r and omized to the intervention group ( n = 275 ) participated in an education program that consisted of information , ergonomics , exercises , pain management , advice for daily life movement , pelvic belt/crutches , and information about delivery . Women r and omized to the control group ( n = 285 ) were not offered any treatment , but were free to seek advice or other treatment . Clinical measures and self‐evaluated utility of the intervention were measured by a visual analogue scale 0–10 . Results . Mean debut of pelvic girdle pain in pregnancy was at week 15 . Altogether 42 % of the women reported problems with low back pain earlier , and 34 % reported a family history of pelvic girdle pain in pregnancy . Median visual analogue scale score for all activities at inclusion was 6 both in the control group and the intervention group . At 6 and 12 months postpartum the score was reduced to 1.7/1.6 and 1.1/0.9 . In the intervention group , 75 % marked a self‐evaluated utility visual analogue scale score > 7 . In the control group , 60 % had search ed for alternative treatment . Conclusions . Postpartum pelvic girdle pain improved with time both in the intervention group and the control group , but there were no statistically significant differences between the groups . Self‐evaluated utility of the intervention was , however , high in the intervention group OBJECTIVE To investigate the effect of an exercise program , including specific stabilizing exercises , on pain intensity and functional ability in women with pregnancy-related low back pain . MET
Output:
| Evidence from individual studies was largely of low quality ( study design limitations , imprecision ) , and suggested that pain and functional disability , but not sick leave , were significantly reduced following a multi-modal intervention ( manual therapy , exercise and education ) for low-back and pelvic pain .
Evidence from single studies suggests that acupuncture or craniosacral therapy improves pregnancy-related pelvic pain , and osteomanipulative therapy or a multi-modal intervention ( manual therapy , exercise and education ) may also be of benefit . |
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