AK Viecelli1, A Tong2, E O’Lone2, A Ju2, C Hanson2, B Sautenet3, JC Craig2, B Manns4, M Howell2, E Chemla5, LS Hooi6, DW Johnson1, T Lee7, C Lok8, KR Polkinghorne9, RR Quinn10, T Vachharajani11, R Vanholder12, L Zuo13, CM Hawley1 on behalf of THE SONG Investigators
1School of Medicine, University of Queensland, Brisbane, Queensland; 2Centre for Kidney Research, The Children’s Hospital at Westmead, Westmead, Sydney, New South Wales; 3University Francois Rabelais, Tours, France; 4Departments of Medicine and Community Health Sciences; Libin Cardiovascular Institute and O’Brien Institute of Public Health, University of Calgary, Calgary, Alberta, Canada; 5St George’s University NHS Foundation Trust, London, United Kingdom; 6Department of Medicine and Haemodialysis Unit, Hospital Sultanah Aminah, Johor Bahru, Malaysia; 7Department of Medicine and Division of Nephrology, Veterans Affairs Medical Center, Birmingham, Alabama, United States; 8Department of Medicine, University of Toronto, Toronto, Ontario, Canada; 9Department of Medicine, Monash University, Melbourne, Victoria; 10Medicine and Community Health Sciences, University of Calgary, Calgary, Canada; 11Division of Nephrology, W.G. (Bill) Hefner Veterans Affairs Medical Center, Salisbury, North Carolina, United States; 12Faculty of Medicine and Health Sciences, Ghent University, Ghent, Belgium; 13Peking University People’s Hospital, Beijing, China
Aim: To identify and describe the preferred core outcome measure for vascular access (VA), and the rationale for its selection, in the context of an international consensus workshop.
Background: Vascular access is a critical outcome domain for all stakeholders in the setting of haemodialysis that is infrequently and inconsistently reported in trials.
Methods: In total, 13 patients/caregivers and 46 health professionals from 12 countries attended. In facilitated breakout groups, participants discussed the development and implementation of a VA core outcome measure. The transcripts were analysed thematically.
Results: Five themes were identified. Participants reiterated the broad relevance of function given its applicability to all VA types, its impacts on quality of life, survival and various access-related outcomes, and the degree of multidisciplinary involvement required to achieve a functioning access. Experiential relevance and severity were identified as drivers for prioritisation of other outcomes, such as aneurysms (patients) or steal syndrome (clinicians). A core outcome measure required absolute feasibility for implementation across different clinical and trial settings and participants advocated for a simple, practical and flexible outcome measure with a pragmatic and operational definition. Integrating patients’ values and preferences was warranted to enhance the relevance of the measure. Ensuring validity and reliability was exemplified in proposed outcome measures for function including “uninterrupted use of the access without the need for interventions” or “ability to receive prescribed dialysis”, while “access blood flow” was deemed too expensive and unreliable.
Conclusions: Patients, caregivers and health professionals identified VA function as the core outcome for inclusion in haemodialysis trials, which should be assessed using a pragmatic, patient-centred, and reliable outcome measure.