1NHMRC Clinical Trials Centre, The Universty of Sydney, Camperdown, Australia, 2Australia and New Zealand Dialysis and Transplant Registry (ANZDATA), Adelaide, Australia, 3School of Medicine, University of Tasmania, Hobart, Australia, 4Australian Institute of Health Innovation, Macquarie University, North Ryde, Australia, 5New Royal Adelaide Hospital, Adelaide, Australia, 6University of Otago Christchurch, Christchurch , New Zealand, 7UK Renal Registry and University of Bristol, Bristol, UK, 8National French ESRD registry REIN, French Agence de la biomedicine, Paris , France, 9Metro South and Ipswich Nephrology and Transplant Services, Brisbane, Australia, 10Centre for Kidney Research, Westmead hospital, The University of Sydney, Westmead, Australia, 11Alberta Health Services Kidney Strategic Clinical Network, University of Calgary, Calgary, Canada, 12Western Sydney Renal Service, Westmead, Australia, 13Australasian Kidney Trials Network, University of Queensland, Brisbane , Australia
Aim: To determine whether regular symptom monitoring with feedback to the renal team can improve health-related quality of life and overall survival among adults with end-stage kidney disease (ESKD) managed with facility-haemodialysis.
Background: Women and men on haemodialysis frequently experience symptoms of severe or overwhelming pain, fatigue, nausea, cramping, itching, trouble sleeping, and depression that contribute to poor quality of life. A focus on laboratory biomarkers of lower relevance to patients, may have resulted in missed opportunities to intervene and reduce symptoms and improve health-related quality of life. Recent trials in other clinical settings have shown that active symptom management can improve overall survival.
Methods: Using a novel ANZDATA registry-based cluster randomised trial design, with adults receiving haemodialysis, the proposed trial will test the hypothesis that: 1) three-monthly symptom monitoring using the IPOS-Renal tool with feedback to clinicians improves health-related quality of life (measured by the EQ-5D), dialysis duration and frequency, and cause-specific mortality compared with usual care; and 2) electronic capture of patient-reported outcomes within a clinical quality registry is cost-effective. A two-arm design of 160 clusters (~3072 individuals) has 90% power to detect a 7% clinically meaningful increase in health-related quality of life (primary endpoint); and 80% power to detect an 11% reduction in deaths from dialysis withdrawal (secondary endpoint).
Results & Conclusions: The findings from SWIFT may result in improved quality of life, lower symptom burden (both severity and number of symptoms), and lower rates of dialysis withdrawal with the potential to change practice in haemodialysis care. Of significance, SWIFT provides a template for ongoing binational monitoring of patient-reported outcome measures and infrastructure for economic evaluation of subsequent interventions.
Associate Professor Rachael Morton, MScMed(Clin Epi)(Hons), PhD, is Director of Health Economics at the NHMRC Clinical Trials Centre, University of Sydney. She is an academic health economist and clinical trialist with research interests in patient reported outcomes and economic evaluation of interventions in chronic kidney disease and cancer. A/Prof Morton leads the ANZDATA PROMs Working Group, and is an Executive Member of the ANZSN Dialysis Advisory Committee. She has over 100 publications and currently holds an NHMRC Translating Research Into Practice (TRIP) Fellowship to embed patient reported outcomes into clinical quality registries.