Rumana Newlands1, Eilidh Duncan1, Justin Presseau2, Shaun Treweek1, Louisa Lawrie1, Peter Bower3, Jim Elliott4, Jill Francis5, Graeme MacLennan1, Margaret Ogden4, Mary Wells6, Miles D Witham7, Bridget Young8, Katie Gillies9. 1. Health Services Research Unit, Health Sciences Building, Foresterhill, Aberdeen AB25 2ZD, UK. 2. Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Canada; School of Epidemiology and Public Health, University of Ottawa, Ottawa, Canada; School of Psychology, University of Ottawa, Ottawa, Canada. 3. NIHR School for Primary Care Research, Centre for Primary Care and Health Services Research, Manchester Academic Health Science Centre, University of Manchester, UK. 4. Health Services Research Unit, Health Sciences Building, Foresterhill, Aberdeen AB25 2ZD, UK; Public Partner. 5. Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Canada; Melbourne School of Health Sciences, The University of Melbourne, Melbourne, Australia. 6. Faculty of Medicine, Department of Surgery and Cancer, Imperial College, London, UK; Imperial College Healthcare NHS Trust, London, UK. 7. AGE Research Group, NIHR Newcastle Biomedical Research Centre, Newcastle University and Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle, UK. 8. Department of Public Health, Policy and Systems, Institute of Population Health, University of Liverpool, Liverpool, UK. 9. Health Services Research Unit, Health Sciences Building, Foresterhill, Aberdeen AB25 2ZD, UK. Electronic address: k.gillies@abdn.ac.uk.
Abstract
OBJECTIVES: 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. STUDY DESIGN AND SETTING: 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. RESULTS: 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. CONCLUSION: 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.
OBJECTIVES: 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. STUDY DESIGN AND SETTING: 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. RESULTS: 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. CONCLUSION: 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.
Authors: Katie Gillies; Jamie Brehaut; Taylor Coffey; Eilidh M Duncan; Jill J Francis; Spencer P Hey; Justin Presseau; Charles Weijer; Marion K Campbell Journal: Trials Date: 2021-12-04 Impact factor: 2.279