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

Journal article

© 2024 Kalsoum et al. This is an open access article distributed under the Creative Commons Attribution License, to view a copy of the license, see: https://creativecommons.org/licenses/by/4.0/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 responseappeared 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 successPeer reviewe

Authors: Kalsoum, R; Lowe, CJM; Gilbert, S; McCaskie, AW; Snow, M

• Publication status: Published
• Peer review status: Peer reviewed
• Publisher: British Editorial Society of Bone and Joint Surgery
• Journal: Bone & Joint Research
• Volume: 13
• Issue: 9
• Pages: 513-524
• Publication date: 2024-09-19
• DOI: 10.1302/2046-3758.139.bjr-2024-0109
• EISSN: 2046-3758
• ISSN: 2046-3758
• Language: English
• Keywords: Surgery; Test (biology); Pathology; Alternative medicine; Osteoarthritis; Physical therapy; Medicine