Measuring Health-Related Quality of Life in Upper Extremity Vascularized Composite Allotransplantation: Development of New Patient-Reported Outcome Items for Hand Transplant

Objective: To develop patient-reported outcome (PRO) items tailored for upper extremity vascularized composite allotransplantation (UE VCA), a procedure that can restore physical functioning and independence and improve psychosocial functioning after hand or arm loss. Design: Based on prior grounded theory-based qualitative and theoretical work, item development was led by recognized experts in psychometrics and outcomes measurement. Item refinement included item review by 17 experts in the field of UE VCA. Cognitive debriefing interviews were conducted by trained, impartial interviewers with 6 English-speaking UE VCA recipients. A professional translatability review was completed on the items. Setting: Academic research center. Participants: Experts (n = 17) and patient stakeholders (n = 6). Interventions: Not applicable. Main Outcome Measures: Not applicable. Results: Fifty-six items were finalized in 7 content areas: Expectations and Perceived Outcomes; Posttransplant Challenges and Complications; Integration and Assimilation of the Transplant; Fitting In; Satisfaction with Hand Function; Satisfaction with Hand Aesthetics; and Hand Function: Sensation. Conclusions: These PRO items offer a structured way to measure health-related quality of life outcomes for UE VCA from the perspective of the recipients, offering an opportunity to collect reliable and quantifiable information on transplant outcomes as a path to move the field forward.