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Developing a reporting guideline for social and psychological intervention trials.
Paul Montgomery1, Evan Mayo-Wilson, Sally Hopewell
1Paul Montgomery and Sean Grant are with Centre for Evidence-Based Intervention, University of Oxford, Oxford, UK. Evan Mayo-Wilson is with Centre for Outcomes Research and Effectiveness, Research Department of Clinical, Educational, and Health Psychology, University College London, London, UK. Sally Hopewell is with Centre for Statistics in Medicine, University of Oxford. Geraldine Macdonald is with the Institute of Child Care Research, Queen's University Belfast, Belfast, UK. David Moher is with the Clinical Epidemiology Program, Ottawa Hospital Research Institute, Centre for Practice-Changing Research, The Ottawa Hospital, Ottawa, Ontario.
Reporting guidelines for randomized controlled trials of social and psychological interventions are needed. Incomplete reporting hinders research use and wastes resources. A new guideline extension is under development.
Area of Science:
- Social and Psychological Intervention Research
- Clinical Trial Methodology
- Research Reporting Standards
Background:
- Randomized controlled trials (RCTs) for complex social and psychological interventions require detailed reporting of methods and interventions.
- Current RCT reports frequently lack adequate information, compromising research utility and ethical standards.
- Inaccurate reporting impedes optimal research application, resource allocation, and participant/consumer engagement.
Purpose of the Study:
- To highlight the critical need for comprehensive reporting in social and psychological intervention RCTs.
- To introduce the development of a new reporting guideline tailored for these interventions.
- To invite participation in establishing consensus for the Consolidated Standards of Reporting Trials (CONSORT) extension.
Main Methods:
- Reviewing the impact of reporting guidelines in medical research.
- Describing the ongoing development process for a new CONSORT extension.
- Facilitating community engagement through a dedicated project website for guideline consensus.
Main Results:
- Reporting guidelines have demonstrably improved the quality of medical research reports.
- A new CONSORT extension specifically for social and psychological interventions is in development.
- Community input is being actively sought to refine and finalize the reporting guidelines.
Conclusions:
- Enhanced reporting guidelines are essential for the effective and ethical conduct of social and psychological intervention research.
- The development of a CONSORT extension aims to address critical reporting gaps in this field.
- Collaborative development ensures guidelines meet the needs of researchers, participants, and consumers.
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