OBJECTIVES: The recent call for action by the FDA and EMA on the use of patient-reported outcome (PRO) data to provide evidence of treatment benefit has been an important development in healthcare decision making. Health-related quality of life (HR-QoL) is now a key element of drug appraisal and its importance is being increasingly recognised by health authorities and payers. This analysis investigated publication patterns of articles on HR-QoL measures over the past decade.

METHODS: Two therapy areas were selected: type 2 diabetes (T2D) and inflammatory bowel disease (IBD). A literature search was performed using EMBASE to identify original articles containing outcomes from the 7 most commonly used HR-QoL instruments; as this analysis focused on HRQoL measures, disease- and symptom-specific PROs were not included. Articles were coded by type of study, audience, and HR-QoL instrument. Descriptive statistics were used to compare changes from 2009–2018.

RESULTS: The proportion of T2D and IBD publications that reported HR-QoL remained constant from 2009–2018 (T2D: [2009: 0.59%; 2018: 0.77%]; IBD: [2009: 0.71%; 2018: 0.74%]). In both therapy areas, HR-QoL publications were mostly observational (T2D 37%; IBD 30%) and cross-sectional studies (T2D 31%; IBD 40%), followed by randomised clinical trial publications (both 27%). Most HR-QoL publications targeted specialist clinical audiences (T2D, 63%; IBD, 84%), with very few targeting health-economists or policy- and decision makers (T2D, 3%; IBD, 4%). The most commonly used HR-QoL instruments were the SF-36 and the EQ-5D instruments.

CONCLUSIONS: The proportion of HR-QoL publications in T2D and IBD remained constant over the past decade. Other studies have observed an increase in HEOR-focused publications over this period, but an increase in HR-QoL publications is lagging. With an increasing focus on HR-QoL and data transparency, there is a need to increase the number of HR-QoL-focused publications targeting payer and decision-making audiences.