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Understanding involvement in surgical orthopaedic randomized controlled trials A qualitative study of patient and health professional views and experiences.pdf

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Understanding involvement in surgical orthopaedic randomized controlled trials A qualitative study of patient and health professional views and experiences.pdf

International Journal of Orthopaedic and Trauma Nursing (2016) 20, 3–12 International Journal of Orthopaedic and Trauma Nursing /locate/ijotn Understanding involvement in surgical orthopaedic randomized controlled trials: A qualitative study of patient and health professional views and experiences Jeremy Horwood PhD (Senior Research Fellow) a,*, Emma Johnson PhD (Research Associate) a, Rachael Gooberman-Hill PhD (Reader in Applied Health Research) b a School of Social and Community Medicine, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS, UK b Musculoskeletal Research Unit, School of Clinical Sciences, University of Bristol, Learning and Research Building, Level 1, Southmead Hospital, Bristol BS10 5NB, UK KEYWORDS Randomized controlled trials; Orthopaedics; Joint replacement surgery; Qualitative; Views Abstract Background: Factors in?uencing patients’ motivations for enrolling in, and their experiences of, orthopaedic randomized controlled trials (RCTs) are not fully understood. Less is known about healthcare professionals’ (HCP) experiences of RCT involvement. Aim: This study investigates patients’ and HCPs’ views and experiences of RCT participation and delivery to inform the planning of future RCTs. Methods: Total hip or knee replacement patients (n = 24) participating in the single- center double-blind APEX RCTs of an intra-operative anesthetic intervention and HCPs (n = 15) involved in trial delivery were interviewed. Data were audio-recorded, transcribed, anonymized and thematically analyzed. Results: Although altruistic reasons for RCT participation were common, patients also weighed up demands of the RCT with the potential bene?ts of taking part, demonstrating the complex and conditional nature of trial participation. HCPs were interested in RCT involvement as a means of contributing towards advances in medical knowledge and also considered the costs and bene?ts of RCT involvement. * Corresponding author. School of Social and Communit