AK VIECELLI1,2, M HOWELL3, A TONG3, A JU3, E O’LONE3, JC CRAIG3, E CHEMLA4, LS HOOI5, T LEE6, C LOK7, KR POLKINGHORNE8, RR QUINN9,T VACHHARAJANI10, R VANHOLDER11, L ZUO12, AB IRISH13,TA MORI13, EM PASCOE1, DW JOHNSON1,2, CM HAWLEY1,2, ON BEHALF OF THESTANDARDIZED OUTCOMES IN NEPHROLOGY (SONG) INITIATIVE
1School of Medicine, University of Queensland, Brisbane, Queensland; 2Department of Nephrology, Princess Alexandra Hospital, Brisbane, Queensland; 3Centre for Kidney Research, The Children’s Hospital at Westmead, Sydney, New South Wales; 4St George’s University NHS Foundation Trust, London, UK; 5Department of Medicine and Haemodialysis Unit, Hospital Sultanah Aminah, Johor Bahru, Malaysia; 6Department of Medicine and Division of Nephrology, Veterans Affairs Medical Center, Birmingham, Alabama, USA; 7Department of Medicine, University of Toronto, Toronto, Ontario, Canada; 8School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria; 9Departments of Medicine & Community Health Sciences, University of Calgary, Calgary, Canada; 10Division of Nephrology, W.G. (Bill) Hefner Veterans Affairs Medical Center, Salisbury, North Carolina, USA; 11Faculty of Medicine and Health Sciences, Ghent University, Ghent, Belgium; 12Peking University People’s Hospital, Beijing, China; 13School of Medicine and Pharmacology, University of Western Australia, Perth, Western Australia
Aim: To identify a core outcome for vascular access, with the expectation that this will be measured and reported in all trials involving patients requiring haemodialysis, based on the shared priorities of patients/caregivers and health professionals.
Background: Vascular access is an essential component for the care of patients requiring haemodialysis, yet clinical trials report a large and diverse range of vascular access outcomes that often cannot readily be compared across trials and have no clear relevance to patients and clinicians.
Methods: Based on a systematic review, qualitative research and meetings with vascular access experts, 12 vascular access outcomes were included in an online survey conducted in English, Chinese, Spanish and Malay. Participants rated the absolute importance of outcomes using a 9-point Likert scale (7-9 being critically important), and the relative importance was determined by a Best-Worst Scale (BWS) using multinomial logistic
Results: The survey was completed by 772 participants (187 [24%] patients/ caregivers and 585 [76%] health professionals) from 58 different countries. Across both groups, the top two outcomes were function (mean 8.4, top 1 on BWS) and infection (mean 8.1, top 2). There was consistency in the prioritization of outcomes between both groups but health professionals rated outcomes overall higher than patients/caregivers (mean differences ranging from 0.09 for interference with activities to 1.3 for access maturation) with the exception of aneurysms which was ranked higher by patients/caregivers (mean difference 1.1, top 3 vs 7).
Conclusions: For patients/caregivers and health professionals, there was consensus on the primary importance of function. A core outcome measure for function will now be developed to improve the consistency and relevance of vascular access outcomes reported in trials in haemodialysis.