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Adaptation of the WOMAC for Use in a Patient Preference Study.
Sarah Stothers Rosenberg1, Xinyi Ng2, Carol Mansfield3
1Office of Biostatistics and Pharmacovigilance, Center for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
Researchers adapted the Western Ontario McMaster Universities Osteoarthritis Index (WOMAC) into patient-reported outcome (PRO) measures for discrete choice experiments (DCEs). This helps quantify endpoint importance in knee osteoarthritis (KOA) trials.
Area of Science:
- Health Economics and Outcomes Research
- Clinical Trial Design
- Patient-Reported Outcomes
Background:
- Discrete Choice Experiments (DCEs) are valuable for understanding patient preferences in healthcare.
- Adapting existing Patient-Reported Outcome (PRO) measures for DCEs can enhance the relevance of clinical trial endpoints.
- The Western Ontario McMaster Universities Osteoarthritis Index (WOMAC) is a widely used PRO for osteoarthritis.
Purpose of the Study:
- To adapt the WOMAC PRO measure into efficacy attributes for a DCE survey.
- To quantify the relative importance of commonly used endpoints in knee osteoarthritis (KOA) clinical trials.
- To assess patient comprehension and trade-off abilities with the adapted attributes.
Main Methods:
- Selected WOMAC pain and function domains for adaptation into two efficacy attributes.
- Developed two versions of a DCE instrument using total domain scores and specific item scores (e.g., walking).
- Conducted pretesting with 26 KOA patients to evaluate attribute comprehension and trade-off capabilities.
Main Results:
- Both adapted WOMAC attribute versions were found meaningful and relevant for treatment decisions.
- Patients demonstrated willingness and ability to make trade-offs between pain and function improvements.
- Patients perceived pain and function improvements as interrelated despite separate evaluation.
Conclusions:
- The adaptation of PRO measures like WOMAC is feasible and valuable for patient preference studies.
- This methodology allows for the integration of clinical trial outcomes with PRO endpoints in preference research.
- Findings support the use of adapted PROs in DCEs to better inform KOA trial endpoint selection.
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