SUN-044 ESTABLISHING A CORE CARDIOVASCULAR OUTCOME MEASURE FOR TRIALS IN HAEMODIALYSIS: REPORT OF AN INTERNATIONAL CONSENSUS WORKSHOP

Abstract

Although cardiovascular disease (CVD) affects more than two thirds of people on haemodialysis and is the leading cause of death, cardiovascular outcomes are infrequently and inconsistently reported in haemodialysis trials. As part of the Standardized Outcomes in Nephrology - Haemodialysis (SONG-HD) initiative to establish core outcome measure for cardiovascular disease, we convened a consensus workshop to prioritize and implement myocardial infarction and sudden cardiac death as potential core outcome measures for cardiovascular disease to be reported in all trials in haemodialysis. In total, 12 patients and caregivers, and 51 health professionals (including physicians, researchers, journal editors, policy makers and industry representatives) from 15 countries participated. Transcripts from the breakout groups were analysed thematically to understand the factors critical to decision making. Five main themes were identified. Participants believed that capturing specific relevance of outcomes to the hemodialysis population was important. For example, within this population the pathophysiology of CVD is different and sudden cardiac death is more prevalent. The dilemmas in using composite outcomes were highlighted and it was suggested that as a core outcome “a composite would be very complex” (Health Professional) with potential for further heterogeneity, despite utility in capturing an event. Addressing challenges in outcome ascertainment, highlighted that the clinical symptoms of CVD in the HD population are often challenging to detect, as are the use of biomarker criteria for diagnosis. Ensuring a meaningful metric for decision-making encompassed making the measurement and reporting of the CVD outcome comprehensible to patients, allowing for some information regarding the degree of event severity or recurrence and ensuring comparability across trials. Finally, enabling and incentivising implementation by ensuring cardiologists, nephrologists and patients are integrally involved in development and supportive of integrating the outcome measure into registries, journals and guidelines. Recommendations from the consensus workshop are summarized in Box 1.Tabled 1Box 1. Recommendations from the Consensus WorkshopMyocardial infarction should be a core outcome measure for cardiovascular disease.Sudden cardiac death should be the core outcome measure for cardiovascular death.Form an expert working group of cardiologists, nephrologists and biomarker specialists to consider the definitions of myocardial infarction and sudden cardiac death in a haemodialysis patient. Open table in a new tab Patients, caregivers and health professionals support myocardial infarction and sudden cardiac death as core outcomes of cardiovascular disease for use in haemodialysis trials. Participants recognised the challenges presented by the measurement and implementation of these outcomes and further work needs to ensure pragmatic and feasible use in haemodialysis trials, and thus strengthen the evidence base for decision-making.