Evidence map›Paper›PMID 35081449›Full record

ArticleJournal of clinical epidemiology2022

Clinical trial registration was associated with lower risk of bias compared with non-registered trials among trials included in systematic reviews.

Kristina Lindsley, Nicole Fusco, Tianjing Li, Rob Scholten, Lotty Hooft

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Journal of clinical epidemiology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
21citing 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

21 citing papers in PubMed, 1 synthesis or guideline 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

5 authors.

Kristina LindsleyJulius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands; Cochrane Netherlands, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands. Electronic address: K.B.Lindsley@umcutrecht.nl.
Nicole FuscoXcenda, LLC, Boston, MA.
Tianjing LiDepartment of Ophthalmology, School of Medicine, University of Colorado Anschutz Medical Campus, Aurora, CO.
Rob ScholtenJulius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands; Cochrane Netherlands, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.
Lotty HooftJulius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands; Cochrane Netherlands, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.

Funding

Maximizing Use of High-Quality Evidence in Eye Care: Cochrane Eyes and Vision US ProjectUG1EY020522 · NEI · UNIVERSITY OF COLORADO DENVER · PI Tianjing Li · 2017 to 2026
$10.1M
NEI NIH HHS UG1 EY020522
6 · The paper itself

Abstract

objectiveTo examine the association between clinical trial registration and risk of bias in clinical trials that have been included in systematic reviews. As a secondary objective, we evaluated the risk of bias among trials registered prospectively vs. retrospectively.

methodClinical trials published in 2005 or after included in a sample of 100 Cochrane systematic reviews published from 2014-2019.

resultsOf 1,177 clinical trials identified, we verified 368 (31%) had been registered, of which 135 (36.7%) were registered prospectively (i.e., before or up to 1 month after enrollment of the first participant). Across the bias domains (one bias assessment for each domain per trial), the percentage of trials at low risk ranged from 29% to 58%; unclear risk ranged from to 26% to 61% and high risk ranged from 2% to 38%. Trials that had been registered had less high or unclear risk of bias in five domains: random sequence generation (univariate risk ratio [RR] 0.69, 95% confidence interval [95% CI] 0.58-0.81), allocation concealment (RR 0.64, 95% CI 0.57-0.72), performance bias (RR 0.65, 95% CI 0.58-0.72), detection bias (RR 0.70, 95% CI 0.62-0.78), and reporting bias (RR 0.62, 95% CI 0.53-0.73). An association between clinical trial registration and high or unclear risk of attrition bias could not be demonstrated nor refuted (RR 1.02, 95% CI 0.89-1.17). It also was observed in terms of overall risk of bias, that registered trials had less high or unclear overall risk of bias than trials that had not been registered (univariate RR 0.29, 95% CI 0.19-0.46). Prospective clinical trial registration was associated with low risks of selection bias due to inadequate allocation concealment, performance bias, and detection bias compared with retrospective clinical trial registration.

conclusionIn a large sample of clinical trials included in recently published systematic reviews of interventions, clinical trial registration was associated with low risk of bias for five of the six domains examined.

Indexed as

Retrospective StudiesBiasHumansProspective StudiesRiskSystematic Reviews as TopicEvidence synthesisRandomized controlled trialResearch methodsRisk of biasSystematic reviewTrial registration

Identifiers

PMID35081449
PMCPMC9875740

What OpenQuestion holds

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Registered trials

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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.