A JU1,2, M UNRUH3, SV JASSAL4, G OBRADOR5, C HANSON1,2, AK VIECELLI6, E O’LONE1,2, S DAVISON7, J DAPUETO8, MA DEW9, R FLUCK10, M GERMAIN11, D O’DONOGHUE12, JC CRAIG1,2, A TONG1,2 FOR THE SONG-HD INITIATIVE
1Sydney School of Public Health, University of Sydney, Sydney, NSW, Australia; 2Centre for Kidney Research, The Children’s Hospital at Westmead, Sydney, NSW, Australia; 3Division of Nephrology, University of New Mexico School of Medicine, Albuquerque, NM, USA; 4Division of Nephrology, Department of Medicine, University Health Network, University of Toronto, Toronto, Ontario, Canada; 5Universidad Panamericana School of Medicine, Mexico City, Mexico; 6Deparment of Nephrology, Princess Alexandra Hospital, Brisbane, Queensland; 7Division of Nephrology and Immunology, Department of Medicine, University of Alberta, Edmonton, Alberta, Canada; 8Departamento de Psicología Médica. Hospital de Clínicas. Facultad de Medicina. Universidad de la República. Montevideo, Uruguay; 9Department of Psychiatry, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA; 10Department of Renal Medicine, Royal Derby Hospital, Derby, United Kingdom; 11Renal and Transplant Associates of New England, Division of Nephrology, Baystate Medical Center, Tufts University School of Medicine, Boston, MA, USA; 12Department of Renal Medicine, Salford Royal Hospital, Salford, United Kingdom
Aim: To describe the process and outcomes of a consensus workshop for the development and implementation of a core outcome measure for fatigue to be used in haemodialysis trials.
Background: Fatigue is a critically important outcome for patients on haemodialysis but is infrequently and inconsistently reported across trials and observational studies, which probably reflects the lack of suitable measures that are feasible and psychometrically robust to use in this setting.
Methods: At an international consensus workshop, 56 (15 patients/caregivers; 42 health professionals) participated from nine different countries in six facilitated breakout groups. All discussions were transcribed and analysed thematically.
Results: Four themes were identified. Drawing attention to a distinct and all-encompassing symptom was explicitly recognising fatigue as a multifaceted symptom that is unique to haemodialysis. Emphasising the pervasive impact of fatigue on life participation confirmed the importance of addressing patient concerns about consequences of fatigue such as being limited in their ability to do usual activities such as work and hobbies, and justified the focus on assessing this restriction. Ensuring meaningfulness of the measure was advocated to facilitate treatment decision-making for both patients and clinicians. Minimising burden of administration meant that the measure should be simple, short, without imposing additional burden given the high level of fatigue in the haemodialysis population. These support a proposed core outcome measure that asks patients about the extent to which fatigue limits participation in usual activities.
Conclusion: Patients, caregivers and health professionals supported the need for a simple, short, and meaningful core outcome measure that focuses on the impact of fatigue on life participation to be used in haemodialysis trials.