Date Published: October 16, 2007
Publisher: Public Library of Science
Author(s): Jan P Vandenbroucke, Erik von Elm, Douglas G Altman, Peter C Gøtzsche, Cynthia D Mulrow, Stuart J Pocock, Charles Poole, James J Schlesselman, Matthias Egger
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 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.
Partial Text: Rational health care practices require knowledge about the aetiology and pathogenesis,
diagnosis, prognosis and treatment of diseases. Randomised trials provide valuable evidence
about treatments and other interventions. However, much of clinical or public health
knowledge comes from observational research . About nine of ten research papers published in
clinical speciality journals describe observational research [2,3].
The STROBE Statement aims to provide helpful recommendations for reporting observational
studies in epidemiology. Good reporting reveals the strengths and weaknesses of a study and
facilitates sound interpretation and application of study results. The STROBE Statement may
also aid in planning observational studies, and guide peer reviewers and editors in their
evaluation of manuscripts.