Many questions in medical research are investigated in observational studies. (1) Much of the research into the cause of diseases relies on cohort, case-control or cross-sectional studies. Observational studies also have a role in research into the benefits and harms of medical interventions. (2) Randomized trials cannot answer all important questions about a given intervention. For example, observational studies are more suitable to detect rare or late adverse effects of treatments, and are more likely to provide an indication of what is achieved in daily medical practice. (3)
Research should be reported transparently so that readers can follow what was planned, what was done, what was found, and what conclusions were drawn. The credibility of research depends on a critical assessment by others of the strengths and weaknesses in study design, conduct and analysis. Transparent reporting is also needed to judge whether and how results can be included in systematic reviews. (4,5) However, in published observational research important information is often missing or unclear. An analysis of epidemiological studies published in general medical and specialist journals found that the rationale behind the choice of potential confounding variables was often not reported. (6) Only few reports of case-control studies in psychiatry explained the methods used to identify cases and controls. (7) In a survey of longitudinal studies in stroke research, 17 of 49 articles (35%) did not specify the eligibility criteria. (8) Others have argued that without sufficient clarity of reporting, the benefits of research might be achieved more slowly, (9) and that there is a need for guidance in reporting observational studies. (10,11)
Recommendations on the reporting of research can improve reporting quality. The Consolidated Standards of Reporting Trials (CONSORT) Statement was developed in 1996 and revised five years later. (12) Many medical journals supported this initiative, (13) which has helped to improve the quality of reports of randomized trials. (14,15) Similar initiatives have followed for other research areas--e.g. for the reporting of meta-analyses of randomized trials (16) or diagnostic studies. (17) We established a network of methodologists, researchers and journal editors to develop recommendations for the reporting of observational research: the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) Statement.
Aims and use of the STROBE Statement
The STROBE Statement is a checklist of items that should be addressed in articles reporting on the three main study designs of analytical epidemiology: cohort, case-control and cross-sectional studies. The intention is solely to provide guidance on how to report observational research well: these recommendations are not prescriptions for designing or conducting studies. Also, while clarity of reporting is a prerequisite to evaluation, the checklist is not an instrument to evaluate the quality of observational research.
Here we present the STROBE Statement and explain how it was developed. In a detailed companion paper, the Explanation and Elaboration article, (18-20) we justify the inclusion of the different checklist items, and give methodological background and published examples of what we consider transparent reporting. We strongly recommend using the STROBE checklist in conjunction with the explanatory article, which is available freely on the web sites of PLoS Medicine (www.plosmedicine.org), Annals of Internal Medicine (www.annals.org) and Epidemiology (www.epidem.com).
Development of the STROBE Statement
We established the STROBE Initiative in 2004, obtained funding for a workshop and set up a web site (www.strobestatement.org). We searched textbooks, bibliographic databases, reference lists and personal files for relevant material, including previous recommendations, empirical studies of reporting and articles describing relevant methodological research. …