Evidence map›Paper›PMID 36171034›Full record

Trial reportBMJ open2022

Peer Reviewed Evaluation of Registered End-Points of Randomised Trials (the PRE-REPORT study): a stepped wedge, cluster-randomised trial.

Christopher W Jones, Amanda Adams, Benjamin S Misemer, Mark A Weaver, Sara Schroter, Hayat Khan, Benyamin Margolis, David L Schriger, Timothy F Platts-Mills

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in BMJ open, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 1 pooled it
–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

6 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Reviewer training for improving grant and journal peer review.The Cochrane database of systematic reviews · 2023
    Article
  4. Article
  5. Article
  6. Article
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

9 authors.

Christopher W JonesEmergency Medicine, Cooper Medical School of Rowan University, Camden, New Jersey, USA jones-christopher@cooperhealth.edu.ORCID 0000-0001-9704-9094
Amanda AdamsMedical Library, Cooper Medical School of Rowan University, Camden, New Jersey, USA.
Benjamin S MisemerEmergency Medicine, University of Michigan, Ann Arbor, Michigan, USA.
Mark A WeaverMathematics and Statistics, Elon University, Elon, North Carolina, USA.
Sara SchroterBMJ, London, UK.ORCID 0000-0002-8791-8564
Hayat KhanEmergency Medicine, Cooper Medical School of Rowan University, Camden, New Jersey, USA.
Benyamin MargolisRollins School of Public Health, Emory University, Atlanta, Georgia, USA.
David L SchrigerEmergency Medicine, UCLA, Los Angeles, California, USA.
Timothy F Platts-MillsOphirex, Inc, Corte Madera, California, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo test whether providing relevant clinical trial registry information to peer reviewers evaluating trial manuscripts decreases discrepancies between registered and published trial outcomes.

designStepped wedge, cluster-randomised trial, with clusters comprised of eligible manuscripts submitted to each participating journal between 1 November 2018 and 31 October 2019.

settingThirteen medical journals.

participantsManuscripts were eligible for inclusion if they were submitted to a participating journal during the study period, presented results from the primary analysis of a clinical trial, and were peer reviewed.

interventionsDuring the control phase, there were no changes to pre-existing peer review practices. After journals crossed over into the intervention phase, peer reviewers received a data sheet describing whether trials were registered, the initial registration and enrolment dates, and the registered primary outcome(s) when enrolment began.

main outcome measureThe presence of a clearly defined, prospectively registered primary outcome consistent with the primary outcome in the published trial manuscript, as determined by two independent outcome assessors.

resultsWe included 419 manuscripts (243 control and 176 intervention). Participating journals published 43% of control-phase manuscripts and 39% of intervention-phase manuscripts (model-estimated percentage difference between intervention and control trials = -10%, 95% CI -25% to 4%). Among the 173 accepted trials, published primary outcomes were consistent with clearly defined, prospectively registered primary outcomes in 40 of 105 (38%) control-phase trials and 27 of 68 (40%) intervention-phase trials. A linear mixed model did not show evidence of a statistically significant primary outcome effect from the intervention (estimated difference between intervention and control=-6% (90% CI -27% to 15%); one-sided p value=0.68).

conclusionsThese results do not support use of the tested intervention as implemented here to increase agreement between prospectively registered and published trial outcomes. Other approaches are needed to improve the quality of outcome reporting of clinical trials. TRIAL REGISTRATION NUMBER: ISRCTN41225307.

Indexed as

Peer ReviewPublicationsHumansRegistriesResearch DesignGENERAL MEDICINE (see Internal Medicine)STATISTICS & RESEARCH METHODSWorld Wide Web technology

Identifiers

PMID36171034
PMCPMC9528603

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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 OpenQuestion graph.