ArticleBMJ open2025
Which variables are associated with recruitment failure? A nationwide review on obstetrical and gynaecological multicentre RCTs (2003-2023).
Article in BMJ open, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.
What it found
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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.
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.
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Who cites it
3 citing papers in PubMed.
- Quality of life 1 year after uterine artery embolization vs hysterectomy for symptomatic adenomyosis (QUESTA study).Acta obstetricia et gynecologica Scandinavica · 2025Trial
- A data-driven methodological framework for representative recruitment in psychiatric research: insights from the DOCUMENT study.BMC psychiatry · 2026Article
- Cross-fusion of digital twins and artificial intelligence in diabetes: from mechanistic elucidation to full-cycle precision management.Frontiers in endocrinology · 2026Review
Corrections and comments
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Authors and funding
9 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveWe aim to assess which variables are associated with recruitment failure of obstetrical and gynaecological randomised controlled trials (RCTs), leading to an extension of the study period.
designNationwide study.
settingA cohort of RCTs supported by the trial centre of the Dutch Consortium of Obstetrics and Gynaecology. POPULATION: We included 83 RCTs that recruited patients between 1 March 2003 and 1 December 2023.
main outcome measuresMain outcome was recruitment target not achieved within 6 months after the preplanned recruitment period. Secondary outcomes were recruitment target not achieved within an extension period of at least 12 months and premature termination of the trial. In all RCTs, we collected information on variables with a potential effect on recruitment failure, recorded at five levels; patient, doctor, participating centre, study organisation and study design.
resultsIn total, 46 of 83 RCTs (55%) did not achieve their targeted recruitment within the preplanned study period with a maximal extension period of 6 months. The most relevant variables for recruitment failure in multivariable risk prediction modelling were presence of a no-treatment arm (where treatment is standard clinical practice), a compensation fee of less than €200 per included patient, funding of less than €350 000, while a preceding pilot study lowered this risk.
conclusionsWe identified that the presence of a no-treatment arm, low funding and a low compensation fee per included patient were the most relevant risk factors for recruitment failure within the preplanned period, while a preceding pilot study lowered this risk. Awareness of these variables is important when designing future studies.
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