Evaluation of patient and healthcare provider (HCP) knowledge, attitudes, and behavior for safety and use of pexidartinib.

Abstract

e23580 Background: Pexidartinib, a kinase inhibitor, is approved for treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) associated with severe morbidity or functional limitations and not amenable to improvement with surgery. Due to risk of serious and potentially fatal liver injury, pexidartinib is available via a Risk Evaluation and Mitigation Strategy (REMS) Program. A requirement of the REMS is to conduct a qualitative evaluation of stakeholder Knowledge, Attitudes, and Behavior (KAB) of risks via surveys. The objective of the qualitative evaluation is to review key risk message questions with respect to understanding, relevance, clarity and provide recommendations on alternative language, phrasing, and structure. Methods: Anonymized, one-on-one 45–60-min phone interviews with patients and HCPs were conducted by UBC. Patients ≥18 y, diagnosed with TGCT (prioritized) or metastasis/sarcoma of the connective tissue, with different levels of education and fluent reading/speaking English were included. To participate, HCPs were required to treat patients with TGCT (prioritized) or metastasis/sarcoma of the connective tissue, treat patients ≥75% of their time, and clearly read/speak English. Participants were required to complete an Interview Release Form (IRF) and confirm access to a computer/tablet. Participants had little/no familiarity with pexidartinib materials. All interviews followed a standard process, used a pre-scripted guide on general instructions, confidentiality, safety event reporting, rapport building and assessment of health literacy (patients only). Feedback regarding understanding, relevance, and clarity were used to recommend potential alternate language/phrasing. To receive compensation participants were required to execute/return the IRF. Results: Twelve patients were interviewed, majority 67% had TGCT; mean age 52 y; 58% female; 42% reported some college/associates degree. 12 HCPs were interviewed, 67% treated patients with TGCT; 100% male; mean years practicing 22; all spent 75% or more time seeing patients; primary specialty Orthopedics. Areas of confusion/misunderstanding were reported, and questions were then revised. Patient findings: complexity and wordiness; HCP findings: repetition/difficulty reading, and some terminology was not self-explanatory. Conclusions: Feedback from HCPs and patients was received to improve the key risk messages of the KAB. Qualitative research is recommended to improve comprehension and data quality collected.