Evidence map›Paper›PMID 40210257›Full record

ArticleBMJ (Clinical research ed.)2025

Evolution of reported patient and public involvement over time in randomised controlled trials in major medical journals and in their protocols: meta-epidemiological evaluation.

Alice Vanneste, Io Wens, Peter Sinnaeve, Claudia Louati, Isabelle Huys, John P A Ioannidis, Tom Adriaenssens

Abstract read
In one paragraph

Article in BMJ (Clinical research ed.), 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed
–field-weighted citation impact
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

17 citing papers in PubMed.

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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

7 authors.

Alice VannesteDepartment of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, Belgium alice.vanneste@kuleuven.be.ORCID 0000-0002-5978-9179
Io WensDepartment of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, Belgium.
Peter SinnaeveDepartment of Cardiovascular Medicine, University Hospitals Leuven, Leuven, Belgium.
Claudia LouatiUmbrella Patient Organization, European Patients' Forum, Brussels, Belgium.
Isabelle HuysDepartment of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, Belgium.
John P A IoannidisMeta-Research Innovation Center at Stanford (METRICS), Stanford University, Stanford, CA, USA.
Tom AdriaenssensDepartment of Cardiovascular Medicine, University Hospitals Leuven, Leuven, Belgium.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo investigate the reporting and evolution of patient and public involvement (PPI) in randomised controlled trials published over time in major medical journals and in their trial protocols.

designMeta-epidemiological evaluation. DATA SOURCE: PubMed was searched for articles reporting randomised controlled trials published since 2015 in four major medical journals and their corresponding peer reviewed protocols. ELIGIBILITY CRITERIA FOR SELECTING STUDIES: The first 10 randomised controlled trials published each year in each journal were included. DATA EXTRACTION: Data extraction focused on involved stakeholders, description and extent of PPI activities/processes, and recognition of PPI contributions. Published articles and protocols were assessed for consistency of the reported PPI in both.

resultsOf the 360 published articles reporting randomised controlled trials and 299 respective protocols, PPI was only reported in 64 (18%) articles and 56 (19%) protocols. When PPI was reported, patients and their representatives were mainly involved, with the most common PPI activity being participation in trial committees (44/64 PPI reporting articles; 39/56 protocols). PPI primarily occurred during the trial development phase, including feedback on study design, review of study materials, and assessment of feasibility. Protocols occasionally had more detailed information than the published articles, but in most cases the PPI contributions were often vague without detailed information on specific outcomes and the effect on decision making within the randomised controlled trial. Recognition of PPI contributions was more frequent in published articles (n=37; 58%) than in protocols (n=18; 32%), mainly in the acknowledgment section.

conclusionThis study found limited PPI reported in randomised controlled trials published in major medical journals and in their respective protocols, underscoring the need for consistent, detailed, and transparent PPI reporting practices in clinical research. STUDY REGISTRATION: https://doi.org/10.17605/OSF.IO/4EQG2.

Indexed as

Community ParticipationPatient ParticipationPeriodicals as TopicRandomized Controlled Trials as TopicHumans

Identifiers

PMID40210257
PMCPMC11983158

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.