Observational studyJournal of clinical epidemiology2018
An observational study showed that explaining randomization using gambling-related metaphors and computer-agency descriptions impeded randomized clinical trial recruitment.
Observational study in Journal of clinical epidemiology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05547165 (Percutaneous Intervention Versus Observational Trial of Arterial Ductus in Low Weight Infants), which is not on this map. Cited by 24 papers.
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.
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.
Percutaneous Intervention Versus Observational Trial of Arterial Ductus in Low Weight Infants
Who cites it
24 citing papers in PubMed.
- Hybrid versus cemented implants for total hip replacement: a randomised feasibility study with embedded qualitative research.BMC musculoskeletal disorders · 2026Trial
- Effectiveness of septoplasty compared to medical management in adults with obstruction associated with a deviated nasal septum: the NAIROS RCT.Health technology assessment (Winchester, England) · 2024Trial
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- Impact of video-assisted thoracoscopic lobectomy versus open lobectomy for lung cancer on recovery assessed using self-reported physical function: VIOLET RCT.Health technology assessment (Winchester, England) · 2022Trial
- Supporting recruitment into complex trials: An embedded qualitative process evaluation in the RADICAL trial of radiofrequency denervation for chronic low back pain.British journal of pain · 2026Article
- Janus kinase inhibitors in palmoplantar pustulosis: a mixed-methods feasibility (JAKPPPOT) trial protocol.BMJ open · 2025Article
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- Article
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- Non-COVID-19 UK clinical trials and the COVID-19 pandemic: impact, challenges and possible solutions.Trials · 2023Article
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- Staff training to improve participant recruitment into surgical randomised controlled trials: A feasibility study within a trial (SWAT) across four host trials simultaneously.Research methods in medicine & health sciences · 2023Article
- A Study of a Culturally and Contextually Situated Multimedia Approach to Recruit a Hard-to-Reach Spanish-Speaking Population for a Randomized Control Trial (RCT).Journal of empirical research on human research ethics : JERHRE · 2022Article
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- Experimenting with modifications to consent forms in comparative effectiveness research: understanding the impact of language about financial implications and key information.BMC medical ethics · 2022Article
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- Review
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Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
17 authors.
Funding
Abstract
objectivesTo explore how the concept of randomization is described by clinicians and understood by patients in randomized controlled trials (RCTs) and how it contributes to patient understanding and recruitment. STUDY DESIGN AND
settingQualitative analysis of 73 audio recordings of recruitment consultations from five, multicenter, UK-based RCTs with identified or anticipated recruitment difficulties.
resultsOne in 10 appointments did not include any mention of randomization. Most included a description of the method or process of allocation. Descriptions often made reference to gambling-related metaphors or similes, or referred to allocation by a computer. Where reference was made to a computer, some patients assumed that they would receive the treatment that was "best for them". Descriptions of the rationale for randomization were rarely present and often only came about as a consequence of patients questioning the reason for a random allocation.
conclusionsThe methods and processes of randomization were usually described by recruiters, but often without clarity, which could lead to patient misunderstanding. The rationale for randomization was rarely mentioned. Recruiters should avoid problematic gambling metaphors and illusions of agency in their explanations and instead focus on clearer descriptions of the rationale and method of randomization to ensure patients are better informed about randomization and RCT participation.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
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.