Mixed-Methods to Define Meaningful Change using Exit Interviewand Clinical Trial Data in Patients with Tenosynovial Giant Cell Tumor (TGCT)

Key Points

• This research aims to define meaningful change using both qualitative and quantitative measures in patients with tenosynovial giant cell tumor.
• Utilized mixed-methods approach combining qualitative interviews and clinical trial data.
• Evaluated responder definitions including PROMIS-PF scores, active range of motion (ROM), and worst stiffness scores.
• Integrated patient perspectives through qualitative interviews to enhance understanding of meaningful change.
• Identified a 3-point improvement for PROMIS-PF as a responder definition.
• Found a 10% improvement in active ROM as significant.
• Determined a 2-point improvement for the worst stiffness numerical rating scale (NRS) as relevant.