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 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 success
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 success
| Original language | English |
|---|---|
| Pages (from-to) | 513 - 524 |
| Number of pages | 12 |
| Journal | Bone Joint Res |
| Volume | 13 |
| Issue number | 9 |
| DOIs | |
| Publication status | Published - 19 Sept 2024 |