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David Moher, MSc; Kenneth F. Schulz, PhD,MBA; Douglas Altman, DSc; for the CONSORT Group

JAMA. 2001;285:1987-1991.

To comprehend the results of a randomized controlled trial (RCT), readers must understand its design, conduct, analysis, and interpretation. That goal can be achieved only through complete transparency from authors. Despite several decades of educational efforts, the reporting of RCTs needs improvement. Investigators and editors developed the original CONSORT (Consolidated Standards of Reporting Trials) statement to help authors improve reporting by using a checklist and flow diagram. The revised CONSORT statement presented in this article incorporates new evidence and addresses some criticisms of the original statement.

The checklist items pertain to the content of the Title, Abstract, Introduction, Methods, Results, and Comment. The revised checklist includes 22 items selected because empirical evidence indicates that not reporting the information is associated with biased estimates of treatment effect or because the information is essential to judge the reliability or relevance of the findings. We intended the flow diagram to depict the passage of participants through an RCT. The revised flow diagram depicts information from 4 stages of a trial (enrollment, intervention allocation, follow-up, and analysis). The diagram explicitly includes the number of participants, according to each intervention group, included in the primary data analysis. Inclusion of these numbers allows the reader to judge whether the authors have performed an intention-to-treat analysis.

In sum, the CONSORT statement is intended to improve the reporting of an RCT, enabling readers to understand a trial's conduct and to assess the validity of its results.

Author Affiliations: University of Ottawa, Thomas C. Chalmers Centre for Systematic Reviews, Ottawa, Ontario (Mr Moher); Family Health International and Department of Obstetrics and Gynecology, School of Medicine, University of North Carolina at Chapel Hill (Dr Schulz); and ICRF Medical Statistics Group and Centre for Statistics in Medicine, Institute of Health Sciences, Oxford, England (Dr Altman).

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