Patient-reported outcome instruments meaningful and relevant for tenosynovial giant cell tumor (TGCT): A qualitative study.

10521 Background: Tenosynovial giant cell tumor (TGCT), a rare locally aggressive neoplasm of the synovium of joints and tendon sheaths, is associated with inflammation, pain and swelling in part due to CSF1R-bearing macrophages recruited to the tumor by genetic elevation of CSF1 activity. Most common treatment is surgery; pharmacological treatments are in development. Patient Reported Outcome (PRO) instruments are potential critical endpoints to demonstrate treatment benefit in clinical trials. Symptoms and other PROs meaningful to TGCT patients have not been formally researched, and instruments to evaluate such outcomes do not exist. Methods: PRO instruments of potential relevance were evaluated by literature review and by clinical and PRO experts. TGCT patients were recruited through clinical sites and the internet for participation in qualitative research interviews to identify predominant symptoms and to test relevance and content validity of selected PRO measures. Results: 22 subjects participated: ...