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A mixed methods approach exploring acceptability and feasibility of trials designed to test drugs targeting prevention of post-traumatic osteoarthritis after knee injury

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Title: A mixed methods approach exploring acceptability and feasibility of trials designed to test drugs targeting prevention of post-traumatic osteoarthritis after knee injury
Authors: Kalsoum, R
Minns Lowe, CJ
Gilbert, S
McCaskie, AW
Snow, M
Wright, K
Bruce, G
Mason, DJ
Watt, FE
Item Type: Journal Article
Abstract: Aims To explore key stakeholder views around feasibility and acceptability of trials seeking to prevent post-traumatic osteoarthritis (PTOA) following knee injury, and provide guidance for next steps in PTOA trial design. Methods Healthcare professionals, clinicians, and/or researchers (HCP/Rs) were surveyed, and the data were presented at a congress workshop. A second and related survey was then developed for people with joint damage caused by knee injury and/or osteoarthritis (PJDs), who were approached by a UK Charity newsletter or Oxford involvement registry. Anonymized data were collected and analyzed in Qualtrics. Results Survey responses (n = 19 HCP/Rs, 39 PJDs) supported studies testing pharmacological agents preventing PTOA. All HCP/Rs and 30/31 (97%) PJDs supported the development of new treatments that improved or delayed knee symptoms and damage to knee structure. PJDs thought that improving structural knee damage was more important than knee symptoms. Both groups found studies more acceptable as expected future benefit and risk of PTOA increased. All drug delivery routes were acceptable. Workshop participants (around n = 60) reflected survey views. Discussions suggested that stratifying using molecular testing for likely drug response appeared to be more acceptable than using characteristics such as sex, age, and BMI. Conclusion Our findings supported PTOA drug intervention studies, including situations where there is low risk of disease, no expected benefit of treatment, and frequent treatment administration. PJDs appeared less risk-averse than HCP/Rs. This work reinforces the benefits of consensus and involvement work in the co-creation of PTOA drug trial design. Involvement of key stakeholders, such as PJDs with different risks of OA and regulatory representatives, are critical for trial design success.
Issue Date: Sep-2024
Date of Acceptance: 10-Jun-2024
URI: http://hdl.handle.net/10044/1/112714
DOI: 10.1302/2046-3758.139.BJR-2024-0109
ISSN: 2046-3758
Publisher: The British Editorial Society of Bone & Joint Surgery
Start Page: 513
End Page: 524
Journal / Book Title: Bone & Joint Research
Volume: 13
Issue: 9
Copyright Statement: © 2024 Kalsoum et al. Open Access This article is distributed under the terms of the Creative Commons Attributions (CC BY 4.0) licence (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium or format, provided the original author and source are credited.
Publication Status: Published
Online Publication Date: 2024-09-19
Appears in Collections:Department of Immunology and Inflammation
Faculty of Medicine



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