SuO008STANDARDISED OUTCOMES IN NEPHROLOGY (SONG): ESTABLISHING A CORE VASCULAR ACCESS OUTCOME MEASURE FOR TRIALS IN HAEMODIALYSIS

Abstract

INTRODUCTION AND AIMS: Vascular access outcomes in haemodialysis (HD) are critically important for patients and health professionals but trial-based evidence to improve access-related outcomes is limited by the inconsistent and selective reporting of outcomes. We aimed to establish a core outcome measure for vascular access to be reported consistently in all trials in HDbased on the shared priorities of patients and health professionals. METHODS: We conducted a systematic review of randomised trials in HD to assess the frequency and consistency of vascular access outcomes; an international survey (in English, Chinese, Malay, and Spanish languages) with patients, caregivers and health professionals (i.e. clinicians, nurses, allied health professionals, researchers, policy makers, and other relevant stakeholders with expertise in HD) to rate and rank selected outcomes using a 9-point Likert scale and Best Worst Scale; and a multi-stakeholder consensus workshop to establish the core outcome for vascular access, describe reasons for the participant's choices and discuss feasibility aspects and measurement properties of the proposed outcome measures. RESULTS: Across 168 randomised trials published in the last 5 years, over 1400 outcome measures to assess 23 vascular access outcomes were identified. Vascular access function was the most frequently reported outcome (81% of trials) followed by infection (38%). In total, 984 participants (246 [25%] patients and caregivers and 738 [75%] health professionals) from 60 countries completed the survey and vascular access function was identified as the top critically important outcome. Themes from the consensus workshop indicated that function was considered the core outcome for vascular access based on its broad applicability to all access types, the multidisciplinary involvement to achieve a functioning access, and the impacts of access function on quality of life, survival and various access-related outcomes. “The need for an intervention to maintain the use of the vascular access for HD” was considered a pragmatic and feasible definition to measure vascular access function that is meaningful to patients and clinicians. Both, “time to first intervention” and “intervention rates” were deemed the most informative and responsive metrics. CONCLUSIONS: The feasibility and reliability of the proposed core outcome measure will be assessed in pilot studies prior to global implementation. Consistent reporting of the core outcome vascular access function, defined as “the need for an intervention to maintain the use of the vascular access for HD” in all trials in HD, will improve the reliability, comparability, usability, and potential impact of trial-based evidence to inform decision-making in HD.