Sekhon Mandeep, Cartwright Martin, Lawes-Wickwar Sadie, McBain Hayley, Ezra Daniel, Newman Stanton, Francis Jill J
Department of Population Health Sciences, School of Population Health and Environmental Sciences, Faculty of Life Sciences & Medicine, King's College London, London, United Kingdom.
School of Health Sciences, City, University of London, London, United Kingdom.
Contemp Clin Trials Commun. 2021 Jan 19;21:100698. doi: 10.1016/j.conctc.2021.100698. eCollection 2021 Mar.
The 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.
To 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.
Eligible 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.
Eighty-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.
Reasons 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.
随机对照试验（RCT）结果的可推广性因招募率低或存在偏差而受到影响。已发表的文献中很少报道参与者拒绝的原因。
应用可接受性理论框架（TFA）来：（1）探究患者报告的拒绝参与一项RCT的原因，该RCT比较了一种新的服务模式（患者发起预约）与标准护理（临床医生安排预约）用于治疗眼睑痉挛和半面痉挛；（2）探究拒绝者对可接受性的认知与不参与之间的关联。
邀请符合条件的患者（n = 242）参与试验。第一阶段：拒绝者提供简短的拒绝理由。对理由进行描述性分析，并对照TFA结构进行审查。
连续的拒绝者参与简短的半结构化访谈，以更深入地探究他们拒绝的原因。访谈进行转录和分析，以TFA作为编码框架。
87名（36%）符合条件的患者拒绝参与试验；所有人都给出了理由。通过对15名拒绝者（17%）的访谈，确定了关于可接受性的四个关键信念：对标准护理满意（n = 41）（49%）、预期患者发起服务的负担、对参与新服务能力缺乏信心以及对新服务有效性存在不确定性。两个主题反映了非TFA因素：试验参与优先级低和完成试验文件的负担。
拒绝参与试验的原因包括：（a）与干预可接受性直接相关之原因，以及（b）更广泛地与试验参与相关之原因。TFA有助于识别新预约系统中可能需要解决以提高可接受性的问题方面。
