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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 generalisability 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 four are specific to each of the three 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, one 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 (http://www.strobe-statement.org/) should be helpful resources to improve reporting of observational research.

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 generalisability. 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 websites 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.

Deficiencies in how research studies are reported are both well-documented and widespread across all medical specialties and study designs. Although randomised trials have received the most attention in this regard, similar concerns have been expressed about reporting of other types of research including diagnostic and epidemiological studies. If a journal article describes in enough detail what was done at each stage of a study, readers will have enough information to allow them to decide on the merits of the results for themselves. From this simple idea comes the scientific rationale of developing guidelines on how to report research. Recommended processes to produce reporting guidelines have evolved over several years during the preparation of a sequence of reporting guidelines starting with CONSORT and QUOROM in the 1990s. We describe initiatives to develop reporting guidelines for diagnostic accuracy studies (STARD) and tumour marker prognostic studies (REMARK).

Healthcare research is extremely important, with the clear potential to influence treatment and prevention of disease, possibly on a global scale. Yet deficiencies in how research studies are reported are both well-documented and widespread across all medical specialties, types of interventions and study designs. Although randomised trials have received the most attention in this regard, similar concerns have been expressed about reporting of other types of research including diagnostic and epidemiological studies. If a journal article describes in enough detail what was done at each stage of a study, readers will have enough information to allow them to decide on the merits of the results for themselves. From this simple idea comes the scientific rationale of developing guidelines on how to report research. We consider desirable attributes of such guidelines, emphasising the importance of being evidence-based where possible. We describe recommended processes to produce guidelines that have evolved over several years during the preparation of a sequence of reporting guidelines including CONSORT, QUOROM, STARD and STROBE.

With the publication of the CONSORT statement there is now increased awareness of the need to adequately report the findings of randomised controlled trials. The CONSORT statement includes a checklist of items that should be addressed in the trial report. The original CONSORT statement was developed to ensure the appropriate reporting of parallel group randomised controlled trials in which individual participants are allocated to different intervention groups. In cluster randomised trials, however, groups of participants, rather than individuals, are randomly allocated to study groups. The process of allocating groups of participants raises additional reporting considerations and led to the publication of an extension to the CONSORT statement specifically for cluster randomised trials. In this paper we review the CONSORT extension to cluster randomised trials, outlining the special features of the cluster randomised trial which must be considered.