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Inconsistent ethics reporting in individual participant data meta-analyses: a call for updating PRISMA and PRISMA-IPD
Rafael Dal-Ré1, Florence T Bourgeois2,3,4, Lars G Hemkens5,6,7
1Epidemiology Unit, Health Research Institute-Fundación Jiménez Díaz University Hospital, Universidad Autónoma de Madrid, Madrid, Spain. rafael.dalre@quironsalud.es.
Individual participant data meta-analyses (IPD-MA) increasingly require reporting on five key ethics items. Updated PRISMA guidelines should incorporate these crucial elements for transparent research reporting.
Area of Science:
- Medical research methodology
- Biostatistics
- Clinical trial reporting standards
Background:
- Individual participant data meta-analysis (IPD-MA) from randomized controlled trials (RCTs) has seen significant growth.
- The number of published IPD-MAs has surged, with 198 appearing in the first nine months of 2025.
- PRISMA 2020 and PRISMA-IPD are current reporting guidelines for these studies.
Purpose of the Study:
- To identify essential ethics reporting items not covered by current PRISMA guidelines.
- To assess the consistency of reporting these ethics items in prominent medical journals.
- To recommend improvements for future IPD-MA reporting standards.
Main Methods:
- Analysis of 19 IPD-MAs published in top general/internal medicine journals (Jan-Sep 2025).
- Evaluation of reporting practices for five specific ethics items related to RCTs and the IPD-MA itself.
- Comparison of reported ethics items against PRISMA 2020 and PRISMA-IPD standards.
Main Results:
- Five critical ethics items are inconsistently reported across IPD-MAs.
- These items include REC approval and informed consent for included RCTs.
- Additional items concern REC approval for the IPD-MA, data de-identification status, and participant consent for data sharing.
Conclusions:
- Readers need clear information on these five ethics items within IPD-MA reports.
- Two items regarding included RCTs should be integrated into PRISMA 2020.
- All five ethics items should be incorporated into the next PRISMA-IPD update for comprehensive reporting.
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