Key result
Patients and clinicians prioritize sudden cardiac death, MI, stroke, and HF for hemodialysis trials.
Why the study?
Cardiovascular outcomes are reported infrequently and inconsistently across trials in hemodialysis, necessitating identification of priority outcomes for a core outcome set.
Cross-Sectional (n=676)
Yes
Patients, caregivers, and health professionals consistently prioritize sudden cardiac death, myocardial infarction, stroke, and heart failure as critically important outcomes to be measured in hemodialysis trials.
Background Cardiovascular disease (CVD) is a major contributor to morbidity and mortality in people on hemodialysis (HD). Cardiovascular outcomes are reported infrequently and inconsistently across trials in HD. This study aimed to identify the priorities of patients/caregivers and health professionals (HPs) for CVD outcomes to be incorporated into a core outcome set reported in all HD trials. Methods In an international online survey, participants rated the absolute importance of 10 cardiovascular outcomes (derived from a systematic review) on a 9-point Likert scale, with 7–9 being critically important. The relative importance was determined using a best–worst scale. Likert means, medians and proportions and best–worst preference scores were calculated for each outcome. Comments were thematically analyzed. Results Participants included 127 (19%) patients/caregivers and 549 (81%) HPs from 53 countries, of whom 530 (78%) completed the survey in English and 146 (22%) in Chinese. All but one cardiovascular outcome (‘valve replacement’) was rated as critically important (Likert 7–9) by all participants; ‘sudden cardiac death’, ‘heart attack’, ‘stroke’ and ‘heart failure’ were all rated at the top by patients/caregivers (median Likert score 9). Patients/caregivers ranked the same four outcomes as the most important outcomes with mean preference scores of 6.2 (95% confidence interval 4.8–7.5), 5.9 (4.6–7.2), 5.3 (4.0–6.6) and 4.9 (3.6–6.3), respectively. The same four outcomes were ranked most highly by HPs. We identified five themes underpinning the prioritization of outcomes: ‘clinical equipoise and potential for intervention’, ‘specific or attributable to HD’, ‘severity or impact on the quality of life’, ‘strengthen knowledge and education’, and ‘inextricably linked burden and risk’. Conclusions Patients and HPs believe that all cardiovascular outcomes are of critical importance but consistently identify sudden cardiac death, myocardial infarction, stroke and heart failure as the most important outcomes to be measured in all HD trials.
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O’Lone et al. (2020) conducted a cross-sectional in Hemodialysis (n=676). Cardiovascular outcomes prioritization survey was evaluated on Absolute and relative importance of 10 cardiovascular outcomes. Patients and health professionals consistently identified sudden cardiac death, myocardial infarction, stroke, and heart failure as the most important cardiovascular outcomes for hemodialysis trials.
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