The CONSORT Statement: Revised Recommendations for Improving the Quality of Reports of Parallel-Group Randomized Trials
Top Cited Papers
- 18 April 2001
- journal article
- review article
- Published by American Medical Association (AMA) in JAMA
- Vol. 285 (15), 1987-1991
- https://doi.org/10.1001/jama.285.15.1987
Abstract
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.Keywords
This publication has 18 references indexed in Scilit:
- Value of Flow Diagrams in Reports of Randomized Controlled TrialsJAMA, 2001
- News from the International Committee of Medical Journal EditorsAnnals of Internal Medicine, 2000
- Size and quality of randomised controlled trials in head injury: review of published studiesBMJ, 2000
- Content and quality of 2000 controlled trials in schizophrenia over 50 yearsBMJ, 1998
- Beyond CONSORT: Need for Improved Reporting Standards for Clinical TrialsJAMA, 1998
- Putting trials on trial--the costs and consequences of small trials in depression: a systematic review of methodology.Journal of Epidemiology and Community Health, 1997
- The quest for unbiased research: Randomized clinical trials and the CONSORT reporting guidelinesAnnals of Neurology, 1997
- CONSORT: An Important Step toward Evidence-Based Health CareAnnals of Internal Medicine, 1997
- Improving the quality of reporting of randomized controlled trials. The CONSORT statementJAMA, 1996
- Empirical evidence of bias. Dimensions of methodological quality associated with estimates of treatment effects in controlled trialsJAMA, 1995