The development of a patient-reported outcome measuring opioid use disorder financial toxicity: Establishing content...

Financial barriers are a major obstacle to engagement in medication treatment for opioid use disorder (OUD), contributing to poor adherence, reduced quality of life, and psychological distress. Globally, the economic impact of substance use disorders, including OUD, strains health systems and individual finances alike, yet measurement of the patient-level financial impact remains underdeveloped. Financial toxicity captures the combined financial and psychosocial impact of treatment, yet no validated patient-reported outcome measure (PROM) exists for individuals receiving medications for OUD (MOUD). This study describes the development and preliminary validation of the Measuring Opioid Use Disorder Financial Toxicity (MOUD-FiT) PROM.

The MOUD-FiT PROM was developed in three steps: (1) item generation via literature review, focus groups with adults receiving MOUD (n = 28 patients across 7 focus groups), and expert interviews (n = 5 treatment professionals); (2) content validation through cognitive debriefing with patients receiving MOUD (n = 7) and the Lawshe method with a panel of 30 lay experts (patients receiving MOUD); and (3) psychometric evaluation of internal consistency using the same 30 participants. Items were rated on a 5-point Likert scale, and analyses included inter-item and item-total correlations and Cronbach's α. The MOUD-FiT PROM requires approximately 5-10 min to complete.

The initial 96-item pool was reduced to 40 items following expert review and thematic classification (affect, coping, direct cost, indirect cost, support). Cognitive debriefing refined wording, and 18 items were excluded based on Lawshe content validity ratios. Further reduction for redundancy and low item-total correlations yielded a 15-item MOUD-FiT PROM. The final instrument showed excellent internal consistency (Cronbach's α=0.90), with mean inter-item and item-total correlations of 0.38 and 0.59, respectively. Items included five affect, three coping, three direct-cost, and four indirect-cost items.

The MOUD-FiT PROM demonstrates preliminary content validity and excellent reliability for assessing financial toxicity in patients receiving MOUD. As a development study, the current findings establish content validity and internal consistency; additional evaluation of construct and criterion validity, test-retest reliability, and factor structure is needed before broader implementation.