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The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) Statement: Guidelines for Reporting Observational Studies

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      Abstract

      Much biomedical research is observational. The reporting of such research is often inadequate, which hampers the assessment of its strengths and weaknesses and of a study's generalisability. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) Initiative developed recommendations on what should be included in an accurate and complete report of an observational study. We defined the scope of the recommendations to cover three main study designs: cohort, case-control, and cross-sectional studies. We convened a 2-day workshop in September 2004, with methodologists, researchers, and journal editors to draft a checklist of items. This list was subsequently revised during several meetings of the coordinating group and in e-mail discussions with the larger group of STROBE contributors, taking into account empirical evidence and methodological considerations. The workshop and the subsequent iterative process of consultation and revision resulted in a checklist of 22 items (the STROBE Statement) that relate to the title, abstract, introduction, methods, results, and discussion sections of articles. 18 items are common to all three study designs and four are specific for cohort, case-control, or cross-sectional studies. A detailed Explanation and Elaboration document is published separately and is freely available on the Web sites of PLoS Medicine, Annals of Internal Medicine, and Epidemiology. We hope that the STROBE Statement will contribute to improving the quality of reporting of observational studies.

      Abstract

      This paper describes the recommendations of The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) Initiative on what should be included in an accurate and complete report of an observational study.

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      Most cited references 28

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      CONSORT statement: extension to cluster randomised trials.

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

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            Author and article information

            Affiliations
            [1 ] Institute of Social and Preventive Medicine (ISPM), University of Bern, Bern, Switzerland
            [2 ] Centre for Statistics in Medicine, University of Oxford, Oxford, United Kingdom
            [3 ] Department of Social Medicine, University of Bristol, Bristol, United Kingdom
            [4 ] London School of Hygiene and Tropical Medicine, University of London, London, United Kingdom
            [5 ] Nordic Cochrane Centre, Copenhagen, Denmark
            [6 ] Department of Clinical Epidemiology, Leiden University Hospital, Leiden, The Netherlands
            Author notes
            * To whom correspondence should be addressed. E-mail: strobe@ 123456ispm.unibe.ch
            Journal
            PLoS Med
            pmed
            PLoS Medicine
            Public Library of Science (San Francisco, USA )
            1549-1277
            1549-1676
            October 2007
            16 October 2007
            : 4
            : 10
            2020495
            10.1371/journal.pmed.0040296
            07-PLME-RA-0728R1 plme-04-10-04
            17941714
            Copyright: © 2007 von Elm 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. For details on further use, see the STROBE Web site ( http://www.strobe-statement.org/). In order to encourage dissemination of the STROBE Statement, this article will also be published and made freely available by Annals of Internal Medicine, BMJ, Bulletin of the World Health Organization, Epidemiology, The Lancet, and Preventive Medicine.
            Counts
            Pages: 5
            Categories
            Research Article
            Public Health and Epidemiology
            Science Policy
            Epidemiology
            Medical Journals
            Research Methods
            Custom metadata
            von Elm E, Altman DG, Egger M, Pocock SJ, Gøtzsche PC, et al. (2007) The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) Statement: Guidelines for reporting observational studies. PLoS Med 4(10): e296. 10.1371/journal.pmed.0040296

            Medicine

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