Strengthening the Reporting of Observational Studies in Epidemiology (STROBE): Explanation and Elaboration

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.

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Affiliated Institutions

• University of Bern CH
• Rigshospitalet DK
• Cancer Research UK GB
• London School of Hygiene & Tropical Medicine GB
• The University of Texas Health Science Center at San Antonio US
• University of North Carolina at Chapel Hill US
• Institute of Social and Preventive Medicine CH
• Leiden University Medical Center NL
• Cochrane DK
• University of Bristol GB
• University Medical Center Freiburg DE
• UPMC Hillman Cancer Center US

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