Why trials lose participants: A multitrial investigation of participants’ perspectives using the theoretical domains framework

• Published in: Journal of clinical epidemiology Vol. 137; pp. 1 - 13
• Main Authors: Newlands, Rumana, Duncan, Eilidh, Presseau, Justin, Treweek, Shaun, Lawrie, Louisa, Bower, Peter, Elliott, Jim, Francis, Jill, MacLennan, Graeme, Ogden, Margaret, Wells, Mary, Witham, Miles D., Young, Bridget, Gillies, Katie
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.09.2021; Elsevier Limited
• Subjects: Attitude to Health; Behavior; Clinical trials; Clinical Trials as Topic - statistics & numerical data; Data collection; Decision making; Domains; Epidemiology; Follow up; Humans; Intervention; Interviews; Pragmatic Clinical Trials as Topic - statistics & numerical data; Questionnaires; Randomized trials; Research Subjects - statistics & numerical data; Retention; Statistical methods; Theory; Follow up; Behavior; Retention; Randomized trials; Theory
• DOI: 10.1016/j.jclinepi.2021.03.007
• ISSN: 0895-4356; 1878-5921

•First study to provide participant reported evidence of behavioral reasons investigating two retention behaviours: questionnaire return and follow-up clinic attendance.•There were seven core TDF domains relevant for both behaviors identified as both barriers and facilitators: knowledge; beliefs about capabilities; environmental context and resources; beliefs about consequences; reinforcements; behavioral regulation; and social influences.•Involved participants from several host trials with varied experiences enhancing opportunities for transferability of findings.•Findings serve as a guiding framework during trial design to enhance participant retention. To use the Theoretical Domains Framework (TDF) to identify barriers and enablers to participant retention in trials requiring questionnaire return and/or attendance at follow-up clinics. We invited participants (n = 607) from five pragmatic effectiveness trials, who missed at least one follow-up time point (by not returning a questionnaire and/or not attending a clinic visit), to take part in semistructured telephone interviews. The TDF informed both data collection and analysis. To establish what barriers and enablers most likely influence the target behavior the domain relevance threshold was set at >75% of participants mentioning the domain. Sixteen participants (out of 25 showing interest) were interviewed. Overall, seven theoretical domains were identified as both barriers and enablers to the target behaviors of attending clinic appointments and returning postal questionnaires. Barriers frequently reported in relation to both target behaviours stemmed from participants’ knowledge, beliefs about their capabilities and the consequences of performing (or not performing) the behavior. Two domains were identified as salient for questionnaire return only: goals; and memory, attention and decision-making. Emotion was identified as relevant for clinic attendance only. This is the first study informed by behavioural science to explore trial participants’ accounts of trial retention. Findings will serve as a guiding framework when designing trials to limit barriers and enhance enablers of retention within clinical trials.