Evidence map›Paper›PMID 31614063›Full record

ArticleResearch synthesis methods2020

From registration to publication: A study on Dutch academic randomized controlled trials.

Joost Huiskens, Boudewijn R J Kool, Jean-Michel Bakker, Emma R J Bruns, Stijn W de Jonge, Pim B Olthof, Belle V van Rosmalen, Thomas M van Gulik, Lotty Hooft, Cornelis J A Punt

Abstract read
In one paragraph

Article in Research synthesis methods, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing 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

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

  1. Time to publication for results of clinical trials.The Cochrane database of systematic reviews · 2024
    Pooled it
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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

10 authors.

Joost HuiskensDepartment of Surgery, Amsterdam UMC, Location AMC, University of Amsterdam, Amsterdam, The Netherlands.ORCID https://orcid.org/0000-0002-0774-1042
Boudewijn R J KoolDepartment of Surgery, Amsterdam UMC, Location AMC, University of Amsterdam, Amsterdam, The Netherlands.
Jean-Michel BakkerDepartment of Medical Oncology, Amsterdam UMC, Location AMC, University of Amsterdam, Amsterdam, The Netherlands.
Emma R J BrunsDepartment of Surgery, Amsterdam UMC, Location AMC, University of Amsterdam, Amsterdam, The Netherlands.
Stijn W de JongeDepartment of Surgery, Amsterdam UMC, Location AMC, University of Amsterdam, Amsterdam, The Netherlands.
Pim B OlthofDepartment of Surgery, Amsterdam UMC, Location AMC, University of Amsterdam, Amsterdam, The Netherlands.
Belle V van RosmalenDepartment of Surgery, Amsterdam UMC, Location AMC, University of Amsterdam, Amsterdam, The Netherlands.ORCID https://orcid.org/0000-0002-4507-7189
Thomas M van GulikDepartment of Surgery, Amsterdam UMC, Location AMC, University of Amsterdam, Amsterdam, The Netherlands.
Lotty HooftCochrane Netherlands, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, The Netherlands.
Cornelis J A PuntDepartment of Medical Oncology, Amsterdam UMC, Location AMC, University of Amsterdam, Amsterdam, The Netherlands.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionRegistration of clinical trials has been initiated in order to assess adherence of the reported results to the original trial protocol. This study aimed to investigate the publication rates, timely dissemination of results, and the prevalence of consistency in hypothesis, sample size, and primary endpoint of Dutch investigator-initiated randomized controlled clinical trials (RCTs).

methodsAll Dutch investigator-initiated RCTs with a completion date between December 31, 2010, and January 1, 2012, and registered in the Trial Register of The Netherlands database were included. PubMed was searched for the publication of these RCT results until September 2016, and the time to the publication date was calculated. Consistency in hypothesis, sample size, and primary endpoint compared with the registry data were assessed.

resultsThe search resulted in a total of 168 Dutch investigator-initiated RCTs. In September 2016, the results of 129 (77%) trials had been published, of which 50 (39%) within 2 years after completion of accrual. Consistency in hypothesis with the original protocol was observed in 108 (84%) RCTs; in 71 trials (55%), the planned sample size was reached; and 103 trials (80%) presented the original primary endpoint. Consistency in all three parameters was observed in 50 studies (39%).

conclusionThis study shows that approximately one out of four Dutch investigator-initiated RCTs remains unpublished 5 years after initiation. The observed low overall consistency with the initial study outline is a matter of concern and warrants improvements in trial design and assessment of trial feasibility.

Indexed as

PublicationsRandomized Controlled Trials as TopicResearch DesignAcademic Medical CentersDatabases, FactualHumansKaplan-Meier EstimateNetherlandsPublication BiasPublishingPubMedRegistriesReproducibility of ResultsResearch PersonnelResearch ReportSample Size

Identifiers

PMID31614063
PMCPMC7078864

What OpenQuestion holds

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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.