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      Reprint—Preferred Reporting Items for Systematic Reviews and Meta-Analyses: The PRISMA Statement

      1 , 2 , 3 , 4 , and the PRISMA Group
      Physical Therapy
      Oxford University Press (OUP)

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          Abstract

          Editor's Note: PTJ's Editorial Board has adopted PRISMA to help PTJ better communicate research to physical therapists. For more, read Chris Maher's editorial starting on page 870.

          Membership of the PRISMA Group is provided in the Acknowledgments.

          This article has been reprinted with permission from the Annals of Internal Medicine from Moher D, Liberati A, Tetzlaff J, Altman DG, The PRISMA Group. Preferred Reporting Items for Systematic Reviews and Meta-Analyses: The PRISMA Statement. Ann Intern Med. Available at: http://www.annals.org/cgi/content/full/151/4/264. The authors jointly hold copyright of this article. This article has also been published in PLoS Medicine, BMJ, Journal of Clinical Epidemiology, and Open Medicine.

          Copyright © 2009 Moher et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

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          Most cited references18

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          Meta-analyses of randomized controlled trials.

          A new type of research, termed meta-analysis, attempts to analyze and combine the results of previous reports. We found 86 meta-analyses of reports of randomized controlled trials in the English-language literature. We evaluated the quality of these meta-analyses, using a scoring method that considered 23 items in six major areas--study design, combinability, control of bias, statistical analysis, sensitivity analysis, and application of results. Only 24 meta-analyses (28 percent) addressed all six areas, 31 (36 percent) addressed five, 25 (29 percent) addressed four, 5 (6 percent) addressed three, and 1 (1 percent) addressed two. Of the 23 individual items, between 1 and 14 were addressed satisfactorily (mean +/- SD, 7.7 +/- 2.7). We conclude that an urgent need exists for improved methods in literature searching, quality evaluation of trials, and synthesizing of the results.
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            Selective serotonin reuptake inhibitors in childhood depression: systematic review of published versus unpublished data.

            Questions concerning the safety of selective serotonin reuptake inhibitors (SSRIs) in the treatment of depression in children led us to compare and contrast published and unpublished data on the risks and benefits of these drugs. We did a meta-analysis of data from randomised controlled trials that evaluated an SSRI versus placebo in participants aged 5-18 years and that were published in a peer-reviewed journal or were unpublished and included in a review by the Committee on Safety of Medicines. The following outcomes were included: remission, response to treatment, depressive symptom scores, serious adverse events, suicide-related behaviours, and discontinuation of treatment because of adverse events. Data for two published trials suggest that fluoxetine has a favourable risk-benefit profile, and unpublished data lend support to this finding. Published results from one trial of paroxetine and two trials of sertraline suggest equivocal or weak positive risk-benefit profiles. However, in both cases, addition of unpublished data indicates that risks outweigh benefits. Data from unpublished trials of citalopram and venlafaxine show unfavourable risk-benefit profiles. Published data suggest a favourable risk-benefit profile for some SSRIs; however, addition of unpublished data indicates that risks could outweigh benefits of these drugs (except fluoxetine) to treat depression in children and young people. Clinical guideline development and clinical decisions about treatment are largely dependent on an evidence base published in peer-reviewed journals. Non-publication of trials, for whatever reason, or the omission of important data from published trials, can lead to erroneous recommendations for treatment. Greater openness and transparency with respect to all intervention studies is needed.
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              Outcome reporting bias in randomized trials funded by the Canadian Institutes of Health Research.

              The reporting of outcomes within published randomized trials has previously been shown to be incomplete, biased and inconsistent with study protocols. We sought to determine whether outcome reporting bias would be present in a cohort of government-funded trials subjected to rigorous peer review. We compared protocols for randomized trials approved for funding by the Canadian Institutes of Health Research (formerly the Medical Research Council of Canada) from 1990 to 1998 with subsequent reports of the trials identified in journal publications. Characteristics of reported and unreported outcomes were recorded from the protocols and publications. Incompletely reported outcomes were defined as those with insufficient data provided in publications for inclusion in meta-analyses. An overall odds ratio measuring the association between completeness of reporting and statistical significance was calculated stratified by trial. Finally, primary outcomes specified in trial protocols were compared with those reported in publications. We identified 48 trials with 68 publications and 1402 outcomes. The median number of participants per trial was 299, and 44% of the trials were published in general medical journals. A median of 31% (10th-90th percentile range 5%-67%) of outcomes measured to assess the efficacy of an intervention (efficacy outcomes) and 59% (0%-100%) of those measured to assess the harm of an intervention (harm outcomes) per trial were incompletely reported. Statistically significant efficacy outcomes had a higher odds than nonsignificant efficacy outcomes of being fully reported (odds ratio 2.7; 95% confidence interval 1.5-5.0). Primary outcomes differed between protocols and publications for 40% of the trials. Selective reporting of outcomes frequently occurs in publications of high-quality government-funded trials.
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                Author and article information

                Journal
                Physical Therapy
                Oxford University Press (OUP)
                0031-9023
                1538-6724
                September 01 2009
                September 01 2009
                : 89
                : 9
                : 873-880
                Affiliations
                [1 ]D. Moher, PhD, Ottawa Methods Centre, Ottawa Hospital Research Institute, The Ottawa Hospital, General Campus, Critical Care Wing (Eye Institute), 6th Floor, 501 Smyth Road, Ottawa, Ontario K1H 8L6, Canada. dmoher@ohri.ca
                [2 ]A. Liberati, MD, DrPH, Università di Modena e Reggio Emilia and Centro Cochrane Italiano, Istituto Ricerche Farmacologiche Mario Negri, Via La Masa 19, 20156 Milan, Italy.
                [3 ]J. Tetzlaff, BSc, Ottawa Methods Centre, Ottawa Hospital Research Institute, The Ottawa Hospital, General Campus, Critical Care Wing (Eye Institute), 6th Floor, 501 Smyth Road, Ottawa, Ontario K1H 8L6, Canada.
                [4 ]D.G. Altman, DSc, Centre for Statistics in Medicine, University of Oxford, Wolfson College Annexe, Linton Road, Oxford OX2 6UD, United Kingdom.
                Article
                10.1093/ptj/89.9.873
                19723669
                d6f6f8e9-7380-4117-8d82-f755d02d37f2
                © 2009
                History

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