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 generalizability. 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.
From the *Institute of Social and Preventive Medicine (ISPM), University of Bern, Bern, Switzerland; †Centre for Statistics in Medicine, University of Oxford, Oxford UK; ‡Department of Social Medicine, University of Bristol, Bristol, UK; §London School of Hygiene and Tropical Medicine, University of London, London, UK; ¶Nordic Cochrane Centre, Copenhagen, Denmark; and ∥Department of Clinical Epidemiology, Leiden University Hospital, Leiden, Netherlands.
The workshop was funded by the European Science Foundation (ESF). Additional funding was received from the Medical Research Council Research and Development Programme and the Medical Research Council Health Services Research Collaboration and the National Health Services Research & Development Methodology Programme.
Editors' note: In order to encourage dissemination of the STROBE Statement, this article is freely accessible on the Web site of Epidemiology (www.epidem.com) and will also be published in Annals of Internal Medicine, BMJ, Bulletin of the World Health Organization, The Lancet, PLoS Medicine, and Preventive Medicine. The authors jointly hold the copyright of this article. For details on further use, see the STROBE website (www.strobe-statement.org). Related articles appear on pages 789, 791, 792, 794, 797, and 805.
Correspondence: Erik von Elm, Institute of Social and Preventive Medicine (ISPM), University of Bern, Finkenhubelweg 11, CH-3012 Bern, Switzerland. E-mail: firstname.lastname@example.org.