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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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2046-3758.139.BJR-2024-0109.pdf | Published version | 1.04 MB | Adobe PDF | View/Open |
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 |
This item is licensed under a Creative Commons License