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Strengthening the Reporting of Observational Studies in Epidemiology (STROBE): Explanation and Elaboration
- Jan P. Vandenbroucke, MD;
- Erik von Elm, MD;
- Douglas G. Altman, DSc;
- Peter C. Gøtzsche, MD;
- Cynthia D. Mulrow, MD;
- Stuart J. Pocock, PhD;
- Charles Poole, ScD;
- James J. Schlesselman, PhD;
- Matthias Egger, MD; and
- for the STROBE initiative
- From Leiden University Medical Center, Leiden, the Netherlands; Institute of Social and Preventive Medicine, University of Bern, Bern, Switzerland; University Medical Centre, Freiburg, Germany; Cancer Research UK/NHS Centre for Statistics in Medicine, Oxford, United Kingdom; Nordic Cochrane Centre, Rigshospitalet, Copenhagen, Denmark; University of Texas Health Science Center, San Antonio, Texas; London School of Hygiene and Tropical Medicine, London, United Kingdom; University of North Carolina School of Public Health, Chapel Hill, North Carolina; University of Pittsburgh Graduate School of Public Health and University of Pittsburgh Cancer Institute, Pittsburgh, Pennsylvania; and University of Bristol, Bristol, United Kingdom.
Abstract
Much medical research is observational. The reporting of observational studies is often of insufficient quality. Poor reporting hampers the assessment of the strengths and weaknesses of a study and the generalizability of its results. Taking into account empirical evidence and theoretical considerations, a group of methodologists, researchers, and editors developed the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) recommendations to improve the quality of reporting of observational studies.
The STROBE Statement consists of a checklist of 22 items, which relate to the title, abstract, introduction, methods, results, and discussion sections of articles. Eighteen items are common to cohort studies, case–control studies, and cross-sectional studies, and 4 are specific to each of the 3 study designs. The STROBE Statement provides guidance to authors about how to improve the reporting of observational studies and facilitates critical appraisal and interpretation of studies by reviewers, journal editors, and readers.
This explanatory and elaboration document is intended to enhance the use, understanding, and dissemination of the STROBE Statement. The meaning and rationale for each checklist item are presented. For each item, 1 or several published examples and, where possible, references to relevant empirical studies and methodological literature are provided. Examples of useful flow diagrams are also included. The STROBE Statement, this document, and the associated Web site (www.strobe-statement.org) should be helpful resources to improve reporting of observational research.
Article and Author Information
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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 Ledergerber, 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 Sydall, Jan P. Vandenbroucke, Ian White, Susan Wieland, Hywel Williams, and Guang Yong Zou.
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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 & 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 4 anonymous reviewers who provided helpful comments on a previous draft of this paper.
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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. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
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Potential Financial Conflicts of Interest: None disclosed.
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Requests for Single Reprints: Matthias Egger, MD, Institute of Social and Preventive Medicine, Finkenhubelweg 11, CH-3012 Bern, Switzerland; e-mail, strobe{at}ispm.unibe.ch.
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Current Author Addresses: Dr. Vandenbroucke: Department of Clinical Epidemiology, Leiden University Medical Center, PO Box 9600, 2300 RC Leiden, the Netherlands.
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Drs. von Elm and Egger: University of Bern, Institute of Social and Preventive Medicine, Finkenhubelweg 11, CH-3012 Bern, Switzerland.
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Dr. Altman: Centre for Statistics in Medicine, Wolfson College Annexe, Linton Road, Oxford OX2 6UD, United Kingdom.
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Dr. Gøtzsche: The Nordic Cochrane Centre, Rigshospitalet, Department 7112, Blegdamsvej 9, DK-2100 Copenhagen Ø, Denmark.
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Dr. Mulrow: American College of Physicians, 190 N. Independence Mall West, Philadelphia, PA 19106-1572.
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Dr. Pocock: Medical Statistics Unit, London School of Hygiene and Tropical Medicine, Keppel Street, London WC1E 7HT, United Kingdom.
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Dr. Poole: Department of Epidemiology, University of North Carolina School of Public Health, Pittsboro Road, Chapel Hill, NC 27599-7435.
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Dr. Schlesselman: Biostatistics Facility, University of Pittsburgh Cancer Institute, Sterling Plaza, Suite 325, 201 North Craig Street, Pittsburgh, PA 15213.
