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Improving the reporting of randomised trials: the CONSORT Statement and beyond.
Douglas G Altman1, David Moher, Kenneth F Schulz
1Centre for Statistics in Medicine, University of Oxford, Wolfson College, Linton Road, Oxford, U.K. doug.altman@csm.ox.ac.uk
Statistics in Medicine
|August 21, 2012
Summary
Poor reporting of randomized trials hinders clinical decision-making and systematic reviews. Reporting guidelines, like the CONSORT Statement, aim to improve the quality and reliability of health research publications.
Area of Science:
- Medical research methodology
- Scientific publishing standards
- Evidence-based medicine
Background:
- Health research publications frequently exhibit deficiencies, impacting the reliability and usability of findings.
- Poorly reported randomized trials impede critical appraisal of methodology, results, and evidence synthesis.
- Inadequate trial reporting limits clinical application, policy development, and inclusion in systematic reviews.
Purpose of the Study:
- To review the evolution of reporting guidelines for randomized trials.
- To highlight the development and impact of the CONSORT Statement.
- To discuss initiatives for enhancing the reliability of medical research literature.
Main Methods:
- Historical review of reporting guideline development for randomized trials.
- Analysis of the CONSORT Statement's emergence and subsequent extensions.
- Examination of related efforts to improve research reporting quality.
Main Results:
- A history of reporting guidelines for randomized trials is presented, leading to the CONSORT Statement in 1996.
- The development, extensions, and impact of CONSORT are detailed.
- Related initiatives addressing research literature reliability are considered.
Conclusions:
- Reporting guidelines are crucial for ensuring adequate information in health research publications.
- The CONSORT Statement and related initiatives have significantly advanced the quality of randomized trial reporting.
- Continued efforts are needed to improve the reliability and utility of published medical research.
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