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      The PRISMA Statement for Reporting Systematic Reviews and Meta-Analyses of Studies That Evaluate Health Care Interventions: Explanation and Elaboration

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          Abstract

          Alessandro Liberati and colleagues present an Explanation and Elaboration of the PRISMA Statement, updated guidelines for the reporting of systematic reviews and meta-analyses.

          Abstract

          Systematic reviews and meta-analyses are essential to summarize evidence relating to efficacy and safety of health care interventions accurately and reliably. The clarity and transparency of these reports, however, is not optimal. Poor reporting of systematic reviews diminishes their value to clinicians, policy makers, and other users.

          Since the development of the QUOROM ( QUality Of Reporting Of Meta-analysis) Statement—a reporting guideline published in 1999—there have been several conceptual, methodological, and practical advances regarding the conduct and reporting of systematic reviews and meta-analyses. Also, reviews of published systematic reviews have found that key information about these studies is often poorly reported. Realizing these issues, an international group that included experienced authors and methodologists developed PRISMA (Preferred Reporting Items for Systematic reviews and Meta-Analyses) as an evolution of the original QUOROM guideline for systematic reviews and meta-analyses of evaluations of health care interventions.

          The PRISMA Statement consists of a 27-item checklist and a four-phase flow diagram. The checklist includes items deemed essential for transparent reporting of a systematic review. In this Explanation and Elaboration document, we explain the meaning and rationale for each checklist item. For each item, we include an example of good reporting and, where possible, references to relevant empirical studies and methodological literature. The PRISMA Statement, this document, and the associated Web site ( http://www.prisma-statement.org/) should be helpful resources to improve reporting of systematic reviews and meta-analyses.

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          Most cited references 160

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          Systematic reviews in health care: Assessing the quality of controlled clinical trials.

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            Pharmaceutical industry sponsorship and research outcome and quality: systematic review.

            To investigate whether funding of drug studies by the pharmaceutical industry is associated with outcomes that are favourable to the funder and whether the methods of trials funded by pharmaceutical companies differ from the methods in trials with other sources of support. Medline (January 1966 to December 2002) and Embase (January 1980 to December 2002) searches were supplemented with material identified in the references and in the authors' personal files. Data were independently abstracted by three of the authors and disagreements were resolved by consensus. 30 studies were included. Research funded by drug companies was less likely to be published than research funded by other sources. Studies sponsored by pharmaceutical companies were more likely to have outcomes favouring the sponsor than were studies with other sponsors (odds ratio 4.05; 95% confidence interval 2.98 to 5.51; 18 comparisons). None of the 13 studies that analysed methods reported that studies funded by industry was of poorer quality. Systematic bias favours products which are made by the company funding the research. Explanations include the selection of an inappropriate comparator to the product being investigated and publication bias.
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              Improving the quality of reports of meta-analyses of randomised controlled trials: the QUOROM statement. Quality of Reporting of Meta-analyses.

              The Quality of Reporting of Meta-analyses (QUOROM) conference was convened to address standards for improving the quality of reporting of meta-analyses of clinical randomised controlled trials (RCTs). The QUOROM group consisted of 30 clinical epidemiologists, clinicians, statisticians, editors, and researchers. In conference, the group was asked to identify items they thought should be included in a checklist of standards. Whenever possible, checklist items were guided by research evidence suggesting that failure to adhere to the item proposed could lead to biased results. A modified Delphi technique was used in assessing candidate items. The conference resulted in the QUOROM statement, a checklist, and a flow diagram. The checklist describes our preferred way to present the abstract, introduction, methods, results, and discussion sections of a report of a meta-analysis. It is organised into 21 headings and subheadings regarding searches, selection, validity assessment, data abstraction, study characteristics, and quantitative data synthesis, and in the results with "trial flow", study characteristics, and quantitative data synthesis; research documentation was identified for eight of the 18 items. The flow diagram provides information about both the numbers of RCTs identified, included, and excluded and the reasons for exclusion of trials. We hope this report will generate further thought about ways to improve the quality of reports of meta-analyses of RCTs and that interested readers, reviewers, researchers, and editors will use the QUOROM statement and generate ideas for its improvement.
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                Author and article information

                Journal
                PLoS Med
                PLoS
                plosmed
                PLoS Medicine
                Public Library of Science (San Francisco, USA )
                1549-1277
                1549-1676
                July 2009
                July 2009
                21 July 2009
                : 6
                : 7
                Affiliations
                [1 ]Università di Modena e Reggio Emilia, Modena, Italy
                [2 ]Centro Cochrane Italiano, Istituto Ricerche Farmacologiche Mario Negri, Milan, Italy
                [3 ]Centre for Statistics in Medicine, University of Oxford, Oxford, United Kingdom
                [4 ]Ottawa Methods Centre, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada
                [5 ]Annals of Internal Medicine, Philadelphia, Pennsylvania, United States of America
                [6 ]The Nordic Cochrane Centre, Copenhagen, Denmark
                [7 ]Department of Hygiene and Epidemiology, University of Ioannina School of Medicine, Ioannina, Greece
                [8 ]UK Cochrane Centre, Oxford, United Kingdom
                [9 ]School of Nursing and Midwifery, Trinity College, Dublin, Ireland
                [10 ]Departments of Medicine, Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada
                [11 ]Kleijnen Systematic Reviews Ltd, York, United Kingdom
                [12 ]School for Public Health and Primary Care (CAPHRI), University of Maastricht, Maastricht, The Netherlands
                [13 ]Department of Epidemiology and Community Medicine, Faculty of Medicine, Ottawa, Ontario, Canada
                Author notes

                ICMJE criteria for authorship read and met: AL DGA JT CM PCG JPAI MC PJD JK DM. Wrote the first draft of the paper: AL DGA JT JPAI DM. Contributed to the writing of the paper: AL DGA JT CM PCG JPAI MC PJD JK DM. Concept and design of the Explanation and Elaboration statement: AL DGA JT DM. Agree with the recommendations: AL DGA JT CM PCG JPAI MC PJD JK DM.

                Article
                08-PLME-GG-3248R2
                10.1371/journal.pmed.1000100
                2707010
                19621070
                Liberati 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.
                Page count
                Pages: 28
                Categories
                Guidelines and Guidance
                Evidence-Based Healthcare

                Medicine

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