Development of patient-reported outcome measures for patients with osteoradionecrosis of the jaw in head and neck cancer survivors(VOUCHER): A Qualitative Study

Osteoradionecrosis of the jaw (ORNJ) is a severe complication of head and neck radiotherapy. It is characterized by necrotic bone that fails to heal and significantly impacts patients’ quality of life (QoL) through chronic pain, functional impairments, and aesthetic concerns. Despite its clinical significance, there is a gap in specific patient-reported outcome measures (PROMs) for ORNJ. This qualitative study aimed to develop a tailored PROM questionnaire for ORNJ patients.
Methods: Methods included a systematic review, expert consultations, focus groups, and cognitive interviews, following COSMIN guidelines for developing health measurement instruments. The systematic review identified existing PROMs but highlighted a lack of psychometric validation in the ORNJ context. Expert feedback was used to create a topic guide for focus groups, which included 19 patients from University College London Hospital and UCL Eastman Dental Institute. Data from these groups informed the initial draft of the questionnaire, which was further refined through cognitive interviews with seven participants to ensure clarity and relevance.
Results: Sixteen patients and seven experts contributed to the development of the final questionnaire, which consists of 11 items with 4 response options, covering various QoL domains affected by ORNJ. This new tool is expected to enhance patient-centered care and support clinical decision-making, ultimately improving outcomes for ORNJ patients.