Evidence map›Paper›PMID 25057391›Full record

ArticleJRSM open2014

Discrepancies between registration and publication of randomised controlled trials: an observational study.

Kate F Walker, Graham Stevenson, James G Thornton

Open access · goldAbstract read
In one paragraph

Article in JRSM open, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed, 6 pooled it
4.5field-weighted citation impact, top 5% of its field
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

24 citing papers in PubMed, 6 syntheses or guidelines pooled it, 43 citations in OpenAlex.

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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

3 authors at 3 institutions in 1 country.

Kate F WalkerAcademic Division of Obstetrics and Gynaecology, Maternity Department, University of Nottingham, Nottingham City Hospital, Hucknall Road, Nottingham NG5 1PB, UK.
Graham StevensonNottingham University Hospitals NHS Trust, Nottingham NG5 1PB, UK.
James G ThorntonAcademic Division of Obstetrics and Gynaecology, Maternity Department, University of Nottingham, Nottingham City Hospital, Hucknall Road, Nottingham NG5 1PB, UK.
Nottingham City Hospital · GBNottingham University Hospitals NHS Trust · GBUniversity of Nottingham · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesTo determine the consistency between information contained in the registration and publication of randomised controlled trials (RCTs).

designAn observational study of RCTs published between May 2011 and May 2012 in the British Medical Journal (BMJ) and the Journal of the American Medical Association (JAMA) comparing registry data with publication data. PARTICIPANTS AND SETTINGS: Data extracted from published RCTs in BMJ and JAMA.

main outcome measuresTiming of trial registration in relation to completion of trial data collection and publication. Registered versus published primary and secondary outcomes, sample size.

resultsWe identified 40 RCTs in BMJ and 36 in JAMA. All 36 JAMA trials and 39 (98%) BMJ trials were registered. All registered trials were registered prior to publication. Thirty-two (82%) BMJ trials recorded the date of data completion; of these, in two trials the date of trial registration postdated the registered date of data completion. There were discrepancies between primary outcomes declared in the trial registry information and in the published paper in 18 (47%) BMJ papers and seven (19%) JAMA papers. The original sample size stated in the trial registration was achieved in 24 (60%) BMJ papers and 21 (58%) JAMA papers.

conclusionsCompulsory registration of RCTs is meaningless if the content of registry information is not complete or if discrepancies between registration and publication are not reported. This study demonstrates that discrepancies in primary and secondary outcomes and sample size between trial registration and publication remain commonplace, giving further strength to the World Health Organisation's argument for mandatory completion of a minimum number of compulsory fields.

Indexed as

clinical trialconsensus development conferencerandomised controlled trial

Identifiers

PMID25057391
PMCPMC4012655
OpenAlexW2032959055

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.