Evidence map›Paper›PMID 42449420›Full record

ArticleBMC medicine2026

Inconsistent ethics reporting in individual participant data meta-analyses: a call for updating PRISMA and PRISMA-IPD.

Rafael Dal-Ré, Florence T Bourgeois, Lars G Hemkens, Soren Holm, David Moher, Florian Naudet

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Article in BMC medicine, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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0cells of the map it votes in
0citing papers in PubMed
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1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors.

Rafael Dal-RéEpidemiology Unit, Health Research Institute-Fundación Jiménez Díaz University Hospital, Universidad Autónoma de Madrid, Madrid, Spain. rafael.dalre@quironsalud.es.ORCID http://orcid.org/0000-0002-0980-2486
Florence T BourgeoisHarvard-MIT Center for Regulatory Science, Harvard Medical School, Boston, MA, USA.
Lars G HemkensPragmatic Evidence Lab, Department of Clinical Research, University of Bern, Bern, Switzerland.
Soren HolmCentre for Social Ethics and Policy, University of Manchester, Manchester, UK.
David MoherCentre for Journalology, Methodological and Implementation Research Program, Ottawa Hospital Research Institute, Ottawa, ON, Canada.
Florian NaudetUniversity Rennes, CHU Rennes, Inserm, EHESP, Irsert (Institut de recherche en santé, environnement et travail - UMR-S 1085, Centre d'investigation clinique de Rennes (CIC1414), Rennes, France.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundInterest in performing individual participant (or patient) data meta-analysis (IPD-MA) from randomized controlled trials (RCTs) has increased in recent years. With our PubMed search approach which considered only the titles of the articles and was conducted in October 2025, the first IPD-MA was published in 1998, whereas 198 were published in the first 9 months of 2025. Researchers use PRISMA 2020 and, above all, PRISMA-IPD to report the results of these studies. MAIN TEXT: There are five ethics items─which are not included in either PRISMA 2020 or PRISMA-IPD─that are inconsistently included in the IPD-MA published in prominent medical journals, as shown in a sample of 19 IPD-MAs published in top general/internal medicine journals between January and September 2025. Two items refer to the RCTs included in the meta-analysis, i.e., whether approval from a research ethics committee (REC) was obtained, and whether participants of those trials provided informed consent. The other three items refer to the IPD-MA itself, i.e., whether it was approved by an REC, what the de-identification status was for the data (i.e. pseudonymized vs. anonymized), and whether the participants in all the trials included in the meta-analysis had given their consent or had not objected to the secondary use and sharing of their data with third parties.

conclusionsDue to their relevance, readers should be informed about these five items in the text of the IPD-MA or, as an alternative in certain cases, in the disclosure section of the IPD-MA published report. Specifically, the two items of information concerning the trials included in the IPD-MA should be included in an updated PRISMA 2020. All five items should be included in the next update of the PRISMA-IPD.

Indexed as

Meta-Analysis as TopicHumansInformed ConsentRandomized Controlled Trials as TopicAnonymizedDataDe-identifiedEthicsInformed consentPRISMAPRISMA-IPDPseudonymized

Identifiers

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.