Abstract 11518: Patient Reported Outcomes Measures Are Infrequently Used in Clinical Studies of Heart Transplant Recipients

Abstract

Introduction / Background: The goals of heart transplantation (HT) are to improve symptoms, restore quality of life, and extend survival. Clinical trials in HT recipients have largely focused on objective outcomes such as measures of cardiac function and survival; however, a paucity of data exists regarding the use of patient reported outcome measures (PROMs) as outcomes in these studies. Aims: We aimed to characterize the use of PROMs in registered clinical trials of HT recipients. Methods: All clinical studies of adult HT recipients were queried from ClinicalTrials.gov, and studies were stratified by inclusion of PROMs. Studies reporting PROMs were identified via specific search terms using the “outcomes measures” field. Summary statistics compared characteristics of studies that did versus did not report PROMs. Results/Data: Between November 1999 and August 2022, 227 studies of HT recipients were registered on ClinicalTrials.gov. At least one PROM was reported in 11% (n=24/227) of registered studies. Studies reporting PROMs were more likely to be conducted outside of the United States (91.7% vs 54.2%, p<0.001) and report a greater number of total primary/secondary outcomes (PROMs: median 7 [IQR: 4, 9] vs. No PROMs: median 3 [IQR: 2, 6]; p<0.001). The majority of studies reporting PROMs (58.3%) were initiated after 2020. Twenty-one distinct PROM tools/domains were reported as outcome measures, with the Short Form Health Survey 36 being most frequently used (n=10/24). Thirteen of the 21 PROMs included questions assessing mental health, whereas only three PROM tools were cardiac-specific (Figure). Conclusions: Only about one in ten registered clinical trials of HT recipients include PROMs, and mental health was the most commonly assessed domain when a PROM was included. Development and validation of PROM tools is needed to assess the multifaceted nature of health-related quality of life in HT recipients.