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

TLDR

Observational biomedical research is common, yet its reporting is often inadequate, limiting assessment of study quality and generalizability. The STROBE Statement aims to improve the quality of reporting in observational studies. The authors defined the scope for cohort, case‑control, and cross‑sectional studies, convened a 2‑day workshop with methodologists, researchers, and editors, and iteratively refined a checklist of items through meetings and email discussions. The resulting 22‑item STROBE Statement checklist covers title, abstract, introduction, methods, results, and discussion, with 18 items common to all designs and four design‑specific items, and an accompanying freely available Explanation and Elaboration document.

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 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.