OMERACT quality-adjusted life-years (QALY) working group: Do current QALY measures capture what matters to patients?

Objective. To understand the limitations with current patient-reported outcome measures (PROM) used to generate quality-adjusted life-years (QALY) in rheumatology, and set a research agenda. Methods. Two activities were undertaken. The first was a scoping review of published studies that have used PROM to generate QALY in rheumatology between 2011 and 2016. The second was an interactive "eyeball test" exercise at Outcome Measures in Rheumatology 13 that compared subdomains of widely used generic PROM, as identified through the scoping review, to subdomains of the Assessment of SpondyloArthritis Health Index (ASAS-HI) condition-specific PROM for ankylosing spondylitis. Results. The scoping review included 39 studies. Five different PROM have been used to generate QALY in rheumatology; however, the EQ-5D and Short Form 6 Dimensions (SF-6D) were used most frequently (in 32 and 9 of included studies, respectively). Special interest group participants identified energy/drive and sleep as 2 key subdomains of the ASAS-HI instrument that may be missed by the EQ-5D, and sexual function as potentially missed by the SF-6D. Participants also expressed concerns that aspects of the process of care and non-health outcomes may be missed. Three ways of incorporating additional subdomains were discussed, including using an alternative generic PROM, modifying an existing generic PROM with "bolt-on" subdomain(s), and generating societal weights for a condition-specific PROM. Conclusion. Three priorities for future research were identified: understanding whether the EQ-5D and SF-6D identify what matters to patients with different rheumatic conditions, analyzing how much patients value process or non-health outcomes, and identifying which approaches to incorporating a greater number of subdomains into the QALY are being undertaken in other disease areas.