Why the study?
Elderly, female, Black, and Hispanic patients with HF are historically underrepresented in clinical trials, and the effect of a pragmatic, virtual trial design on representation is unknown.
Does a pragmatic, virtual trial design affect patient representation in heart failure clinical trials?
Does a pragmatic, virtual trial design affect patient representation in heart failure clinical trials?
This study evaluates whether a pragmatic, virtual enrollment strategy impacts the representation of historically underrepresented groups in heart failure clinical trials.
Answers are grounded in this paper and cite their sources.
Phone outreach with digital methods may aid diverse HF trial enrollment; leaves open generalizability beyond this single-center pragmatic design.
atients with heart failure (HF) who are elderly, women, Black race, or Hispanic ethnicity are historically underrepresented in clinical trials. Designed as a pragmatic trial with virtual enrollment (via email, text message, and telephone call) of patients seen in a HF clinic, the PRO-HF (Patient-Reported Outcome Measurement in Heart Failure Clinic) trial evaluates the impact of routine assessment of patient-reported health status before HF clinic visits. The effect of pragmatic, virtual trial design on representation is unknown. We sought to identify shared characteristics of enrolled PRO-HF trial patients.
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Gupta et al. (2024) studied this question.
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