Evidence map›Paper›PMID 39893396›Full record

ArticleBMC medical research methodology2025

Protocol publication rate and comparison between article, registry and protocol in RCTs.

Sylvain Mathieu, Jean-Baptiste Bouillon-Minois, Laurent Renard Triché, Emmanuel Coudeyre, De Chazeron Ingrid, Finotto Thomas, Catherine Laporte, Xavier Moisset, Ludovic Samalin, Guillaume Villatte and 2 more

Abstract readComparative Study
In one paragraph

Article in BMC medical research methodology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing 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

4 citing papers in PubMed.

  1. Review
  2. Article
  3. Article
  4. Reporting quality of randomized controlled trials in theJournal of Korean biological nursing science · 2025
    Review
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

12 authors.

Sylvain MathieuRheumatology Department, CHU Clermont-Ferrand, Clermont-Ferrand, France. smathieu@chu-clermontferrand.fr.
Jean-Baptiste Bouillon-MinoisEmergency Medicine, Clermont Auvergne University, Clermont-Ferrand, France.
Laurent Renard TrichéDepartment of Perioperative Medicine, CHU Clermont-Ferrand, Clermont-Ferrand, France.
Emmanuel CoudeyreService de Médecine Physique et de Réadaptation, CHU Clermont-Ferrand, Hôpital Louise Michel, INRAE, Université Clermont Auvergne, Clermont-Ferrand, France.
De Chazeron IngridService de Psychiatrie Adulte et d'Addictologie, CHU Clermont-Ferrand, CNRS, Université Clermont-Auvergne, Institut Pascal, Clermont-Ferrand, France.
Finotto ThomasDepartment of Perioperative Medicine, CHU Clermont-Ferrand, Clermont-Ferrand, France.
Catherine LaporteDépartement de Médecine Générale, Université Clermont Auvergne, UFR de Médecine et Profession paramédicales de Clermont-Ferrand, Clermont-Ferrand, F-63000, France.
Xavier MoissetCHU Clermont-Ferrand, Neuro-Dol, Université Clermont Auvergne, Inserm, Clermont- Ferrand, France.
Ludovic SamalinDepartment of Psychiatry, CHU Clermont-Ferrand, University of Clermont Auvergne, CNRS, UMR 6602, Clermont-Ferrand, IP, France.
Guillaume VillatteClermont Auvergne University, CNRS, SIGMA Clermont, ICCF, Clermont-Ferrand, France.
Bruno PereiraBiostatistics Unit (DRCI), 55174 CHU Clermont-Ferrand, Clermont-Ferrand, France.
Methodology And Evidence Statistics for Transparency in medical Research and Outcome reporting (MAESTRO) working group

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIncreasing transparency in clinical research is crucial to avoid misleading conclusions. Registering clinical trials prior to participant enrolment is mandatory, and the publication of trial protocols could further enhance transparency. However, the impact of protocol publication on primary outcomes (PO) and sample sizes (SS) remains unclear. This study aimed to determine the rates of trial protocol publication and registration for a sample of randomized controlled trials (RCTs) and to compare the consistency of published and registered PO and SS.

methodsA search was conducted in MEDLINE via PubMed

resultsOut of 1119 references, 589 (52.6%) were RCTs. The corresponding protocol was published for 146 RCTs (24.8%) including 40 over 140 (28.6%) (6 without end date available) after the trial had ended. Sixty-two (42.4%) protocols were published before the trial conclusion, with no significant differences between PO and SS in published protocols and their corresponding articles. Five hundred and twenty-eight (89.6%) RCTs were registered, 225 over 510 (44%) were registered before the study start with no differences in PO and SS between article and registry. Articles published in generalist or high impact factor journals were associated with higher frequencies of published protocols and trial registration and a lower frequency of difference in PO and SS between articles, registries, and published protocols.

conclusionsWhile publishing trial protocols may enhance transparency in peer-review process, the initial registered protocol alone appears sufficient for ensuring consistency in primary outcomes and sample sizes. Protocol publication does not seem to provide additional significant benefits in terms of outcome reporting.

Indexed as

Clinical Trial Protocols as TopicPublishingRandomized Controlled Trials as TopicRegistriesResearch DesignHumansJournal Impact FactorSample SizeProtocol publicationRCTRegistration

Identifiers

PMID39893396
PMCPMC11786558

What Socratic holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

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 Socratic graph.