Establishing a Core Outcome Measure for Fatigue in Patients on Hemodialysis: A Standardized Outcomes in Nephrology-Hemodialysis (SONG-HD) Consensus Workshop Report

Angela Ju , Mark Unruh , Sara Davison , Juan Dapueto , Mary Amanda Dew , Richard Fluck , Michael Germain , Sarbjit V. Jassal , Gregorio Obrador , Donal O'Donoghue , Michelle A. Josephson , Jonathan C. Craig , Andrea Viecelli , Emma O'Lone , Camilla S. Hanson , Braden Manns , Benedicte Sautenet (1) , Martin Howell , Bharathi Reddy , Caroline Wilkie , Claudia Rutherford , Allison Tong

1 SPHERE - MethodS in Patients-centered outcomes and HEalth ResEarch

Fatigue is one of the most highly prioritized outcomes for patients and clinicians, but remains infrequently and inconsistently reported across trials in hemodialysis. We convened an international Standardized Outcomes in Nephrology-Hemodialysis (SONG-HD) consensus workshop with stakeholders to discuss the development and implementation of a core outcome measure for fatigue. 15 patients/caregivers and 42 health professionals (clinicians, researchers, policy makers, and industry representatives) from 9 countries participated in breakout discussions. Transcripts were analyzed thematically. 4 themes for a core outcome measure emerged. Drawing attention to a distinct and all-encompassing symptom was explicitly recognizing fatigue as a multifaceted symptom unique to hemodialysis. Emphasizing the pervasive impact of fatigue on life participation justified the focus on how fatigue severely impaired the patient's ability to do usual activities. Ensuring relevance and accuracy in measuring fatigue would facilitate shared decision making about treatment. Minimizing burden of administration meant avoiding the cognitive burden, additional time, and resources required to use the measure. A core outcome measure that is simple, is short, and includes a focus on the severity of the impact of fatigue on life participation may facilitate consistent and meaningful measurement of fatigue in all trials to inform decision making and care of patients receiving hemodialysis.

Mots clés: Clinical trials; consensus; Consensus; core outcome; dialysis symptoms; Education; end-stage renal disease (ESRD); fatigue; Fatigue; hemodialysis; Humans; kidney disease; life participation; Nephrology; nephrology research; outcome; Outcome Assessment; Health Care; outcome measure; patient-centered research; patient-reported outcome (PRO); quality of life; Renal Dialysis; Research Report; Surveys and Questionnaires; tiredness

Domaines: Sciences du Vivant [q-bio]

Angela Ju, Mark Unruh, Sara Davison, Juan Dapueto, Mary Amanda Dew, et al.. Establishing a Core Outcome Measure for Fatigue in Patients on Hemodialysis: A Standardized Outcomes in Nephrology-Hemodialysis (SONG-HD) Consensus Workshop Report. American Journal of Kidney Diseases, 2018, 72 (1), pp.104-112. ⟨10.1053/j.ajkd.2017.12.018⟩. ⟨hal-03158617⟩