FP628A CORE OUTCOME SET FOR TRIALS IN HAEMODIALYSIS ESTABLISHED BY THE STANDARDISED OUTCOMES IN NEPHROLOGY - HAEMODIALYSIS INITIATIVE

Abstract

Introduction and Aims:Despite more than 1500 randomised trials in HDpub-lished over the last decade, substantive improvements in patient outcomes remain to be seen. The inconsistent and selective reporting of highly variable outcomes, and the omission of outcomes that are meaningful to patients and clinicians, can hamper the reliability and comparability of outcomes across trials. The Standardised Outcomes in Nephrology (SONG)-HD initiative aims to establish a set of core outcomes to be reported in all trials in HD based on the shared priorities of patients and health professionals. Methods: SONG-HD used a5-phase evidence-based consensus process tofirst establish the core outcome domains, defined as the most critically important outcomes to be reported in all trials in HD: a systematic review of outcomes reported in trials in HD; focus groups with nominal group technique with patients and caregivers to identify and prioritise outcomes; multi-stakeholder interviews to elicit individual perspectives on outcomes; an international three-round online Delphi survey with patients, caregivers, and health professionals to achieve consensus on critically important outcomes; and a consensus workshop to establish the core outcome set. For each outcome domain, a core outcome measure was then defined using a 4-phase process: a systematic review of outcome measures reported in clinical trials; an international multi-stakeholder survey to rate and rank outcomes used to assess the outcome domain; consensus workshops to discuss measurement properties and feasibility aspects; and pilot and validation studies to evaluate the identified core outcome measures. Results: In total, 1376 patients, caregivers and health professionals from 73 countries participated in the consensus process to identify the four core outcome domains for HD: fatigue, vascular access, cardiovascular disease, and mortality. For fatigue, the impact of fatigue on life participation was the most critically important dimension (n=571 participants [44% patients/caregivers]) and a 3-item questionnaire to assess fatigue is currently being validated. For vascular access, the function of the HD access was identified as the most important outcome (n=1043 participants [25 % patients/caregivers]) and defined as the need for an intervention to maintain the use of the vascular access for HD. For cardiovascular disease, myocardial infarction and sudden cardiac death were considered of most critical importance (n=550 participants [25% patients/caregivers]) and the measurement definitions are currently being developed. Conclusions: Consistent reporting of the core outcome set-fatigue, vascular access function, myocardial infarction, sudden cardiac death, and all-cause mortality-as a minimum in all trials in HD will improve the integrity and comparability of trial-based evidence to inform decision-making inHD. This may help improve outcomes that are meaningful and important to patients and their clinicians.