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

16 October 2007 | Volume 147 Issue 8 | Pages 573-577

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 3 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. Eighteen items are common to all 3 study designs and 4 are specific for cohort, case–control, or cross-sectional studies. A detailed Explanation and Elaboration document is published separately and is freely available at http://www.annals.org and on the Web sites of PLoS Medicine and Epidemiology. We hope that the STROBE Statement will contribute to improving the quality of reporting of observational studies.

Author and Article Information

From the Institute of Social and Preventive Medicine, University of Bern, Bern, Switzerland; Centre for Statistics in Medicine, University of Oxford, Oxford, United Kingdom; University of Bristol, Bristol, United Kingdom; London School of Hygiene and Tropical Medicine, University of London, London, United Kingdom; Nordic Cochrane Centre, Copenhagen, Denmark; and Leiden University Hospital, Leiden, the Netherlands.

Note: The following individuals have contributed to the content and elaboration of the STROBE Statement: Douglas G. Altman, Maria Blettner, Paolo Boffetta, Hermann Brenner, Geneviève Chêne, Cyrus Cooper, George Davey-Smith, Erik von Elm, Matthias Egger, France Gagnon, Peter C. Gøtzsche, Philip Greenland, Sander Greenland, Claire Infante-Rivard, John Ioannidis, Astrid James, Giselle Jones, Bruno Le-dergerber, Julian Little, Margaret May, David Moher, Hooman Momen, Alfredo Morabia, Hal Morgenstern, Cynthia D. Mulrow, Fred Paccaud, Stuart J. Pocock, Charles Poole, Martin Röösli, Dietrich Rothenbacher, Kenneth Rothman, Caroline Sabin, Willi Sauerbrei, Lale Say, James J. Schlesselman, Jonathan Sterne, Holly Syddall, Jan P. Vandenbroucke, Ian White, Susan Wieland, Hywel Williams, and Guang Yong Zou.

Acknowledgments: The authors thank Gerd Antes, Kay Dickersin, Shah Ebrahim, Richard Lilford, and Drummond Rennie for supporting the STROBE Initiative. They also thank the following institutions that have hosted working meetings of the coordinating group: Institute of Social and Preventive Medicine, University of Bern, Bern, Switzerland; Department of Social Medicine, University of Bristol, Bristol, United Kingdom; London School of Hygiene and Tropical Medicine, London, United Kingdom; Nordic Cochrane Centre, Copenhagen, Denmark; and Centre for Statistics in Medicine, University of Oxford, Oxford, United Kingdom. Finally, they thank the 6 reviewers who provided helpful comments on a previous draft of this paper.

Grant Support: The workshop was funded by the European Science Foundation. Additional funding was received from the Medical Research Council Health Services Research Collaboration and the National Health Services Research & Development Methodology Programme.

Potential Financial Conflicts of Interest: None disclosed.

Requests for Single Reprints: Erik von Elm, MD, Institute of Social and Preventive Medicine, University of Bern, Finkenhubelweg 11, CH-3012 Bern, Switzerland; e-mail, strobe{at}ispm.unibe.ch.

Current Author Addresses: Drs. von Elm and Egger: University of Bern, Institute of Social and Preventive Medicine, Finkenhubelweg 11, CH-3012 Bern, Switzerland.

Dr. Altman: Centre for Statistics in Medicine, Wolfson College Annexe, Linton Road, Oxford OX2 6UD, United Kingdom.

Dr. Pocock: Medical Statistics Unit, London School of Hygiene and Tropical Medicine, Keppel Street, London WC1E 7HT, United Kingdom.

Dr. Gøtzsche: The Nordic Cochrane Centre, Rigshospitalet, Department 7112, Blegdamsvej 9, DK-2100 Copenhagen Ø, Denmark.

Dr. Vandenbroucke: Department of Clinical Epidemiology, Leiden University Medical Center, PO Box 9600, 2300 RC Leiden, The Netherlands.