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Methods used to develop the SPIRIT 2024 and CONSORT 2024 Statements
Ruth Tunn1, Isabelle Boutron2, An-Wen Chan3
1Oxford Clinical Trials Research Unit, University of Oxford, Oxford, UK; Centre for Statistics in Medicine, University of Oxford, Oxford, UK.
Journal of Clinical Epidemiology
|March 1, 2024
Summary
Updated reporting guidelines for clinical trials, SPIRIT 2024 and CONSORT 2024, were developed through stakeholder consensus. These guidelines harmonize the reporting of trial protocols and results for better research transparency.
Area of Science:
- Clinical Trials Methodology
- Research Reporting Standards
- Evidence-Based Medicine
Background:
- The SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) and CONSORT (Consolidated Standards of Reporting Trials) guidelines are crucial for transparent reporting of clinical trial protocols and results.
- Previous versions (SPIRIT 2013, CONSORT 2010) required updates to incorporate new evidence and extensions.
- Harmonization between protocol and results reporting guidelines is essential for consistency.
Purpose of the Study:
- To describe the methods and rationale for developing the updated SPIRIT 2024 and CONSORT 2024 reporting guidelines.
- To harmonize the SPIRIT and CONSORT guidelines for consistent reporting of trial protocols and results.
- To incorporate content from key extensions and stakeholder feedback into the updated guidelines.
Main Methods:
- Simultaneous development of SPIRIT 2024 and CONSORT 2024 to ensure harmonization.
- Scoping review of comments on previous versions and relevant extensions.
- International online Delphi survey with stakeholders for feedback on proposed changes.
- Online expert consensus meeting to discuss Delphi results and finalize recommendations.
- Drafting and revising updated SPIRIT and CONSORT checklists based on feedback.
Main Results:
- A total of 33 potential changes were generated for SPIRIT and CONSORT.
- 317 participants responded to the Delphi survey (68% Round 1).
- 14 out of 35 proposed changes reached the consensus threshold in the Delphi survey.
- Consensus meeting participants agreed to implement 11/14 Delphi-consensus changes and 4/21 non-consensus changes.
- Further recommendations were made for refining key concepts and improving clarity.
Conclusions:
- The forthcoming SPIRIT 2024 and CONSORT 2024 Statements offer updated, harmonized guidance for reporting clinical trial protocols and results.
- The development process integrated current empirical evidence and extensive stakeholder input.
- The methodology report aims to assist future reporting guideline development teams.
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