OBJECTIVES: To assess whether clinical trials for non-pharmaceutical interventions are collecting quality of life and cost data, an area of product evaluation that is becoming more pertinent as regulations for medical technologies progress toward those for pharmaceuticals. This case study is performed in the US heart failure population.

METHODS: A systematic literature review (Prospero registration CRD42023410084) was conducted in PubMed and EMBASE to identify literature published between 2008 and 2023. The inclusion criteria were randomised clinical trials with patients in the US over the age of 18 who had been diagnosed with heart failure in the last 12 months; had an intervention of heart failure monitoring; and had a comparator of watchful waiting. Full-text review of included studies identified those reporting on hospital readmission, emergency room visits, survival, time in hospital, costs and/or quality of life.

RESULTS: Searches identified 2,248 unique abstracts across the two databases. After title and abstract screening, and full-text review, 31 were included for analysis. Ten studies (32.2%) reported on quality of life, with the Minnesota Living with Heart Failure and the Kansas City Cardiomyopathy Questionnaire being used equally. EQ-5D and SF-36 were each reported once. Four studies (12.9%) reported on costs, with the most commonly collected being total cost of care, which ranged from USD 11,000 to USD 52,000 (2022 USD) per patient. However, heterogeneity in the type of costs collected was evident across the included studies. Only two of 31 studies (6.5%) reported on both quality of life and costs.

CONCLUSIONS: In clinical trials of non-pharmaceutical interventions, costs and quality of life are infrequently reported and unlikely to both be reported in a trial. There is room for improvement in this area of clinical trial design for medical technologies. At this time, health-economic analysis of single trials for medical technology will remain rare.