Key result
Black and Hispanic patients prioritize quality of life but mistrust clinical trial randomization.
Why the study?
Randomized trials comparing CABG with PCI have underrepresented women, Black, and Hispanic patients, and primary composite endpoints often fail to capture patient-important outcomes like symptoms and QoL.
Patients from underrepresented groups prioritize functional recovery and trust, highlighting the need for culturally responsive communication and patient-centered outcomes in revascularization research.
Mistrust and QoL priorities among underrepresented patients warrant culturally responsive trial design; leaves open optimal implementation in revascularization RCTs.
Background: Randomized trials comparing coronary artery bypass grafting (CABG) with percutaneous coronary intervention (PCI) have historically underrepresented women, Black, and Hispanic patients. Moreover, primary composite cardiovascular endpoints often fail to reflect the outcomes most important to patients, such as symptoms, function, and quality of life (QoL). The Revascularization Choices Among Underrepresented Groups Evaluation (RECHARGE) trial of PCI vs CABG addresses this gap by enrolling only women, Black, or Hispanic patients and incorporating death and QoL as a hierarchical primary endpoint tested by the win ratio. To inform RECHARGE's patient-centered design, qualitative interviews with patients to develop recruitment strategies and to elicit their treatment priorities. Methods: We conducted a prospective qualitative study involving 13 focus groups and 11 individual interviews with 42 adults (ages 45-75 years) who had cardiovascular disease with or without a prior PCI or CABG. Participants self-identified as Black or Hispanic and were recruited through academic and community networks. Interviews were conducted in English or Spanish, transcribed, and thematically analyzed using directed content analysis. Recruitment continued until thematic saturation. Results: Participants (83% women; 69% Hispanic; 31% Black) expressed 3 key themes: (1) limited understanding of cardiovascular disease and feeling dismissed by providers; (2) prioritization of QoL, independence, and recovery in treatment decisions; and (3) concerns about randomization in clinical trials, driven by mistrust and a need for clearer, culturally responsive communication. Conclusions: Patients from underrepresented groups prioritize functional recovery and trust in research engagement. These findings directly informed RECHARGE's inclusive recruitment and highlight strategies to advance equity-focused, patient-centered cardiovascular research.
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Rivera et al. (2025) studied Cardiovascular disease (n=42). Qualitative interviews with 42 Black and Hispanic patients (83% women) identified prioritization of quality of life and functional recovery, alongside mistrust concerning clinical trial randomization.
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