Evidence map›Paper›PMID 32291261›Full record

ArticleBMJ (Clinical research ed.)2020

Prospective registration and reporting of trial number in randomised clinical trials: global cross sectional study of the adoption of ICMJE and Declaration of Helsinki recommendations.

Mustafa Al-Durra, Robert P Nolan, Emily Seto, Joseph A Cafazzo

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in BMJ (Clinical research ed.), 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 41 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
41citing papers in PubMed, 5 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

41 citing papers in PubMed, 5 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Review
  7. Article
  8. Article
  9. Article
  10. Review
  11. Article
  12. [Analysis of the global registration status of clinical trials for artificial intelligence medical device].Sheng wu yi xue gong cheng xue za zhi = Journal of biomedical engineering = Shengwu yixue gongchengxue zazhi · 2025
    Article
  13. Article
  14. Review
  15. Article
  16. Article
  17. Article
  18. Article
  19. Article
  20. 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

4 authors.

Mustafa Al-DurraCentre for Global eHealth Innovation, Techna Institute, University Health Network, Toronto General Hospital, Toronto, ON, M5G 2C4 Canada maldurra@ehealthinnovation.org.ORCID https://orcid.org/0000-0002-4108-4808
Robert P NolanPsychiatry Department and Institute of Medical Sciences, University of Toronto, ON, Canada.
Emily SetoInstitute of Health Policy, Management and Evaluation, Dalla Lana School of Public Health, University of Toronto, ON, Canada.
Joseph A CafazzoInstitute of Health Policy, Management and Evaluation, Dalla Lana School of Public Health, University of Toronto, ON, Canada.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesTo evaluate the compliance with prospective registration and inclusion of the trial registration number (TRN) in published randomised controlled trials (RCTs), and to analyse the rationale behind, and detect selective registration bias in, retrospective trial registration.

designCross sectional analysis. DATA SOURCES: PubMed, the 17 World Health Organization's trial registries, University of Toronto library, International Committee of Medical Journal Editors (ICMJE) list of member journals, and the InCites Journal Citation Reports. STUDY SELECTION CRITERIA: RCTs registered in any WHO trial registry and published in any PubMed indexed journal in 2018.

resultsThis study included 10 500 manuscripts published in 2105 journals. Overall, 71.2% (7473/10500) reported the TRN and 41.7% (3013/7218) complied with prospective trial registration. The univariable and multivariable analyses reported significant relations (P<0.05) between reporting the TRN and the impact factor and ICMJE membership of the publishing journal. A significant relation (P<0.05) was also observed between prospective trial registration and the registry, region, condition, funding, trial size, interval between paper registration and submission dates, impact factor, and ICMJE membership of the publishing journal. A manuscript published in an ICMJE member journal was 5.8 times more likely to include the TRN (odds ratio 5.8, 95% confidence interval 4.0 to 8.2), and a published trial was 1.8 times more likely to be registered prospectively (1.8, 1.5 to 2.2) when published in an ICMJE member journal compared with other journals. This study detected a new form of bias, selective registration bias, with a higher proportion (85.2% (616/723)) of trials registered retrospectively within a year of submission for publication. Higher rates of retrospective registrations were observed within the first three to eight weeks after enrolment of study participants. Within the 286 RCTs registered retrospectively and published in an ICMJE member journal, only 2.8% (8/286) of the authors included a statement justifying the delayed registration. Reasons included lack of awareness, error of omission, and the registration process taking longer than anticipated.

conclusionsThis study found a high compliance in reporting of the TRN for trial papers published in ICMJE member journals, but prospective trial registration was low.

Indexed as

Helsinki DeclarationCross-Sectional StudiesGuideline AdherencePublishingRandomized Controlled Trials as TopicResearch Design

Identifiers

PMID32291261
PMCPMC7190012

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.