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CONSORT 2010 Explanation and Elaboration: Updated guidelines for reporting parallel group randomised trials
David Moher1, Sally Hopewell, Kenneth F Schulz
1Ottawa Methods Centre, Ottawa Hospital Research Institute, Ottawa Hospital, Ottawa, Ontario, Canada. dmoher@ohri.ca
Journal of Clinical Epidemiology
|March 30, 2010
Summary
The CONSORT 2010 Statement enhances reporting quality for randomised controlled trials (RCTs). This updated guideline improves clarity and addresses issues like selective outcome reporting bias for more reliable research.
Area of Science:
- Clinical Trials Methodology
- Evidence-Based Medicine
- Scientific Reporting Standards
Background:
- Reporting quality of randomised controlled trials (RCTs) is suboptimal, hindering assessment of findings' validity and reliability.
- Inadequate reporting and design in RCTs are linked to biased treatment effect estimates, compromising their role as the gold standard.
- The CONSORT (Consolidated Standards of Reporting Trials) statement was developed to improve RCT reporting quality.
Purpose of the Study:
- To present the revised CONSORT 2010 Statement, an update aimed at improving the quality of RCT reporting.
- To provide an updated explanation and elaboration document to enhance understanding and application of the CONSORT statement.
- To incorporate recent advancements and recognized issues in trial reporting, such as selective outcome reporting bias.
Main Methods:
- The CONSORT statement, first published in 1996 and updated in 2001, was further revised following an expert meeting in January 2007.
- The CONSORT 2010 Statement includes an updated checklist and flow diagram for authors reporting RCTs.
- An extensively revised explanatory and elaboration document accompanies the CONSORT 2010 Statement, detailing rationale and examples.
Main Results:
- The CONSORT 2010 Statement improves wording and clarity of the reporting checklist.
- It incorporates recommendations for newly recognized reporting issues, including selective outcome reporting bias.
- The accompanying document provides rationale, examples of good reporting, and references for each checklist item.
Conclusions:
- The CONSORT 2010 Statement, its explanatory document, and website serve as valuable resources for improving RCT reporting.
- Enhanced transparency in RCT reporting is crucial for accurate appraisal and interpretation of trial findings.
- Adherence to CONSORT guidelines promotes more reliable and valid research, benefiting systematic reviews and clinical decision-making.
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