Evidence map›Paper›PMID 33537506›Full record

ArticleContemporary clinical trials communications2021

Does prospective acceptability of an intervention influence refusal to participate in a randomised controlled trial? An interview study.

Mandeep Sekhon, Martin Cartwright, Sadie Lawes-Wickwar, Hayley McBain, Daniel Ezra, Stanton Newman, Jill J Francis

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Article in Contemporary clinical trials communications, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
20citing 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

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

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  9. Measuring Patient-Reported Acceptability Outcomes via the Program Acceptability Tool for Telehealth.Telemedicine journal and e-health : the official journal of the American Telemedicine Association · 2025
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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

7 authors.

Mandeep SekhonDepartment of Population Health Sciences, School of Population Health and Environmental Sciences, Faculty of Life Sciences & Medicine, King's College London, London, United Kingdom.
Martin CartwrightSchool of Health Sciences, City, University of London, London, United Kingdom.
Sadie Lawes-WickwarDepartment of Primary Care and Population Health, University College London, London, United Kingdom.
Hayley McBainSchool of Health Sciences, City, University of London, London, United Kingdom.
Daniel EzraAdnexal Department, Moorfields Eye Hospital, London, United Kingdom.
Stanton NewmanSchool of Health Sciences, City, University of London, London, United Kingdom.
Jill J FrancisSchool of Health Sciences, City, University of London, London, United Kingdom.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe generalizability of findings of Randomised Controlled Trials (RCTs) is undermined by low or biased recruitment. Reasons for participant refusal are infrequently reported in published literature.

aimsTo apply the Theoretical Framework of Acceptability (TFA) to: (1) explore patient-reported reasons for declining to participate in a RCT comparing a new service model (patient-initiated appointments) with standard care (appointments scheduled by clinician) for managing blepharospasm and hemifacial spasm; (2) to explore associations between decliners' perceptions of acceptability and non-participation.

methodEligible patients (n = 242) were approached to participate in the trial. Phase 1: decliners provided a brief reason for refusal. Reasons were analysed descriptively and reviewed against TFA constructs. PHASE 2: Consecutive decliners participated in short semi-structured interviews, to explore their reasons for refusal in more depth. Interviews were transcribed and analysed, with the TFA as a coding framework.

resultsEighty-seven (36%) eligible patients refused trial participation; all provided a reason. From interviews with 15 decliners (17%), four key beliefs about acceptability were identified: happy with standard care (n = 41) (49%), anticipated burden of patient-initiated service, lack of confidence in ability to engage with new service and uncertainties about effectiveness of new service. Two themes reflected non-TFA factors: trial participation a low priority and burden of completing trial documentation.

conclusionReasons for refusal trial participation included: (a) reasons directly associated with intervention acceptability, and (b) reasons associated with trial participation more broadly. The TFA facilitated identification of problematic aspects of the new appointment booking system which could be addressed to enhance acceptability.

Indexed as

AcceptabilityPatient recruitmentRandomised controlled trial

Identifiers

PMID33537506
PMCPMC7840848

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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.