Willingness to participate in placebo-controlled surgical trials of the knee.

Autor:	Wall L; School of Psychological Sciences, University of Newcastle, Newcastle, Australia.; Hunter Medical Research Institute, Newcastle, Australia.; Newcastle Business School, University of Newcastle, Newcastle, Australia., Bunzli S; School of Health Sciences and Social Work, Griffith University, Brisbane, Australia.; Physiotherapy Department, Royal Brisbane and Women's Hospital, Brisbane, Australia., Nelson E; Department of Surgery, St Vincent's Hospital, The University of Melbourne, Melbourne, Australia., Hawke LJ; Department of Surgery, St Vincent's Hospital, The University of Melbourne, Melbourne, Australia., Genie M; Newcastle Business School, The University of Newcastle, Newcastle, Australia.; Health Economics Research Unit, University of Aberdeen, Aberdeen, UK.; Department of Population Health Sciences, Duke University, Durham, North Carolina, USA., Hinwood M; Hunter Medical Research Institute, Newcastle, Australia.; School of Medicine and Public Health, The University of Newcastle, Newcastle, Australia., Lang D; Hunter Medical Research Institute, Newcastle, Australia.; School of Medicine and Public Health, The University of Newcastle, Newcastle, Australia., Dowsey MM; Department of Surgery, St Vincent's Hospital, The University of Melbourne, Melbourne, Australia., Clarke P; Health Economics Research Centre, University of Oxford, Oxford, Oxford, UK.; School of Population and Global Health, University of Melbourne, Melbourne, Australia., Choong PF; Department of Surgery, St Vincent's Hospital, The University of Melbourne, Melbourne, Australia., Balogh ZJ; Department of Traumatology, John Hunter Hospital and University of Newcastle, Newcastle, Australia., Lohmander LS; Department of Clinical Sciences Lund, Orthopaedics, Lund University, Lund, Sweden., Paolucci F; Newcastle Business School, The University of Newcastle, Newcastle, Australia.; School of Economics & Management, University of Bologna, Bologna, Italy.
Jazyk:	angličtina
Zdroj:	The bone & joint journal [Bone Joint J] 2024 Dec 01; Vol. 106-B (12), pp. 1408-1415. Date of Electronic Publication: 2024 Dec 01.
DOI:	10.1302/0301-620X.106B12.BJJ-2023-1266.R2
Abstrakt:	Aims: Surgeon and patient reluctance to participate are potential significant barriers to conducting placebo-controlled trials of orthopaedic surgery. Understanding the preferences of orthopaedic surgeons and patients regarding the design of randomized placebo-controlled trials (RCT-Ps) of knee procedures can help to identify what RCT-P features will lead to the greatest participation. This information could inform future trial designs and feasibility assessments. Methods: This study used two discrete choice experiments (DCEs) to determine which features of RCT-Ps of knee procedures influence surgeon and patient participation. A mixed-methods approach informed the DCE development. The DCEs were analyzed with a baseline category multinomial logit model. Results: The proportion of respondents (surgeons n = 103; patients n = 140) who would not participate in any of the DCE choice sets (surgeons = 31%; patients = 40%), and the proportion who would participate in all (surgeons = 18%; patients = 30%), indicated strong views regarding the conduct of RCT-Ps. There were three main findings: for both surgeons and patients, studies which involved an arthroscopic procedure were more likely to result in participation than those with a total knee arthroplasty; as the age (for patients) and years of experience (for surgeons) increased, the overall likelihood of participation decreased; and, for surgeons, offering authorship and input into the RCT-P design was preferred for less experienced surgeons, while only completing the procedure was preferred by more experienced surgeons. Conclusion: Patients and surgeons have strong views regarding participation in RCT-Ps. However, understanding their preferences can inform future trial designs and feasibility assessments with regard to recruitment rates. Competing Interests: S. Bunzli reports a project grant from National Health & Medical Research Council (#1163613), related to this study. M. Dowsey reports a project grant from National Health & Medical Research Council, related to this study, as well as grants from National Health & Medical Research Council, Medical Research Future Fund, HCF Foundation, and Eli Lilly, unrelated to this study. P. F. Choong reports grants from the Medical Research Future Fund and the National Health & Medical Research Council, royalties or licenses from Johnson & Johnson, and consulting fees from Stryker and Medacta, all of which are unrelated to this study. L. S. Lohmander reports consulting fees from Arthro Therapeutics, unrelated to this study. F. Paolucci reports a grant from the National Health & Medical Research Council (APP1163613), related to this study. (© 2024 Wall et al.)
Databáze:	MEDLINE
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