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; Martin Howell; Bharathi Reddy; Caroline Wilkie; Claudia Rutherford; Allison Tong; Adeera Levin; Andrew Narva; Angela Wang; Angelique Ralph; Annette Montalbano Moffat; Barry Bell; Brenda Hemmelgarn; Brigitte Schiller; Carmel Hawley; Christen Perry; Christoph Wanner; Daniel Cukor; Daniel Perez; David Cella; David Harris; David Johnson; David Roer; David Van Wyck; David Wheeler; Deborah Deyhle; Derrick Gill; Dori Schatell; Elena Bavlovlenkov; Eric Weinhandl; Fergus Caskey; Francesca Tentori; Giorgos Sakkas; Harvey Saver; Harvey Wells; James Wadee; Jamilah Akbar; Jane Carter; Jennifer Flythe; Jenny Shen; John Kusek; John Gill; Joyce Beverly; Jule Pinter; Kirsten Johansen; Klemens Meyer; Leonard Lirtzman; Linda Wagner-Weiner; Luigi Costabile; Manisha Jhamb; Marcello Tonelli; Marinella Ruospo; Martin Howell; Maurizio Bossola; Michael Thomas; Nadia Mendez; Neil Powe; Nieltje Gedney; Noah Rouse; Pamela Kaden; Peter Kerr; Peter Tugwell; Quinetta Taylor; Rachel Sand; Roberto Pecoits-Filho; Sally Crowe; Sarah Gill; Sheila Jowsey-Gregoire; Stephen Fadem; Stephen McDonald; Steven Weisbord; Suetonia Palmer; S. Susan Hedayati; Tess Harris; Thomas F. Hiemstra; Uthma Muhammed; Vanessa McNorton; Vanja Sikirica; Vivek Jha; William Herrington; Wim Van Biesen; Wolfgang Winkelmayer; Zeeshan Butt

doi:10.1053/j.ajkd.2017.12.018

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, Martin Howell, Bharathi Reddy, Caroline WilkieClaudia Rutherford, Allison Tong, Adeera Levin, Andrew Narva, Angela Wang, Angelique Ralph, Annette Montalbano Moffat, Barry Bell, Brenda Hemmelgarn, Brigitte Schiller, Carmel Hawley, Christen Perry, Christoph Wanner, Daniel Cukor, Daniel Perez, David Cella, David Harris, David Johnson, David Roer, David Van Wyck, David Wheeler, Deborah Deyhle, Derrick Gill, Dori Schatell, Elena Bavlovlenkov, Eric Weinhandl, Fergus Caskey, Francesca Tentori, Giorgos Sakkas, Harvey Saver, Harvey Wells, James Wadee, Jamilah Akbar, Jane Carter, Jennifer Flythe, Jenny Shen, John Kusek, John Gill, Joyce Beverly, Jule Pinter, Kirsten Johansen, Klemens Meyer, Leonard Lirtzman, Linda Wagner-Weiner, Luigi Costabile, Manisha Jhamb, Marcello Tonelli, Marinella Ruospo, Martin Howell, Maurizio Bossola, Michael Thomas, Nadia Mendez, Neil Powe, Nieltje Gedney, Noah Rouse, Pamela Kaden, Peter Kerr, Peter Tugwell, Quinetta Taylor, Rachel Sand, Roberto Pecoits-Filho, Sally Crowe, Sarah Gill, Sheila Jowsey-Gregoire, Stephen Fadem, Stephen McDonald, Steven Weisbord, Suetonia Palmer, S. Susan Hedayati, Tess Harris, Thomas F. Hiemstra, Uthma Muhammed, Vanessa McNorton, Vanja Sikirica, Vivek Jha, William Herrington, Wim Van Biesen, Wolfgang Winkelmayer, Zeeshan Butt

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Abstract

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.

Original language	English
Pages (from-to)	104-112
Number of pages	9
Journal	American Journal of Kidney Diseases
Volume	72
Issue number	1
DOIs	https://doi.org/10.1053/j.ajkd.2017.12.018
Publication status	Published - 1 Jul 2018
Externally published	Yes
Event	SONG-HD Fatigue Consensus workshop - Chicago, Chicago, United States Duration: 19 Nov 2016 → 19 Nov 2016 https://songinitiative.org/projects/song-hd/song-hd-fatigue/

Keywords

Clinical trials
consensus
core outcome
dialysis symptoms
end-stage renal disease (ESRD)
fatigue
hemodialysis
kidney disease
life participation
nephrology research
outcome
outcome measure
patient-centered research
patient-reported outcome (PRO)
quality of life
tiredness

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Ju, A., Unruh, M., Davison, S., Dapueto, J., Dew, M. A., Fluck, R., Germain, M., Jassal, S. V., Obrador, G., O'Donoghue, D., Josephson, M. A., Craig, J. C., Viecelli, A., O'Lone, E., Hanson, C. S., Manns, B., Sautenet, B., Howell, M., Reddy, B., ... Butt, Z. (2018). 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, 72(1), 104-112. https://doi.org/10.1053/j.ajkd.2017.12.018

@article{72e66e6b8485408fb58248ae70505bbf,

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

abstract = "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.",

keywords = "Clinical trials, consensus, core outcome, dialysis symptoms, end-stage renal disease (ESRD), fatigue, hemodialysis, kidney disease, life participation, nephrology research, outcome, outcome measure, patient-centered research, patient-reported outcome (PRO), quality of life, tiredness",

author = "Angela Ju and Mark Unruh and Sara Davison and Juan Dapueto and Dew, {Mary Amanda} and Richard Fluck and Michael Germain and Jassal, {Sarbjit V.} and Gregorio Obrador and Donal O'Donoghue and Josephson, {Michelle A.} and Craig, {Jonathan C.} and Andrea Viecelli and Emma O'Lone and Hanson, {Camilla S.} and Braden Manns and Benedicte Sautenet and Martin Howell and Bharathi Reddy and Caroline Wilkie and Claudia Rutherford and Allison Tong and Adeera Levin and Andrew Narva and Angela Wang and Angelique Ralph and Moffat, {Annette Montalbano} and Barry Bell and Brenda Hemmelgarn and Brigitte Schiller and Carmel Hawley and Christen Perry and Christoph Wanner and Daniel Cukor and Daniel Perez and David Cella and David Harris and David Johnson and David Roer and {Van Wyck}, David and David Wheeler and Deborah Deyhle and Derrick Gill and Dori Schatell and Elena Bavlovlenkov and Eric Weinhandl and Fergus Caskey and Francesca Tentori and Giorgos Sakkas and Harvey Saver and Harvey Wells and James Wadee and Jamilah Akbar and Jane Carter and Jennifer Flythe and Jenny Shen and John Kusek and John Gill and Joyce Beverly and Jule Pinter and Kirsten Johansen and Klemens Meyer and Leonard Lirtzman and Linda Wagner-Weiner and Luigi Costabile and Manisha Jhamb and Marcello Tonelli and Marinella Ruospo and Martin Howell and Maurizio Bossola and Michael Thomas and Nadia Mendez and Neil Powe and Nieltje Gedney and Noah Rouse and Pamela Kaden and Peter Kerr and Peter Tugwell and Quinetta Taylor and Rachel Sand and Roberto Pecoits-Filho and Sally Crowe and Sarah Gill and Sheila Jowsey-Gregoire and Stephen Fadem and Stephen McDonald and Steven Weisbord and Suetonia Palmer and Hedayati, {S. Susan} and Tess Harris and Hiemstra, {Thomas F.} and Uthma Muhammed and Vanessa McNorton and Vanja Sikirica and Vivek Jha and William Herrington and {Van Biesen}, Wim and Wolfgang Winkelmayer and Zeeshan Butt",

year = "2018",

month = jul,

day = "1",

doi = "10.1053/j.ajkd.2017.12.018",

language = "English",

volume = "72",

pages = "104--112",

journal = "American Journal of Kidney Diseases",

issn = "0272-6386",

publisher = "American Journal of Kidney Diseases",

number = "1",

note = "SONG-HD Fatigue Consensus workshop ; Conference date: 19-11-2016 Through 19-11-2016",

url = "https://songinitiative.org/projects/song-hd/song-hd-fatigue/",

}

Ju, A, Unruh, M, Davison, S, Dapueto, J, Dew, MA, Fluck, R, Germain, M, Jassal, SV, Obrador, G, O'Donoghue, D, Josephson, MA, Craig, JC, Viecelli, A, O'Lone, E, Hanson, CS, Manns, B, Sautenet, B, Howell, M, Reddy, B, Wilkie, C, Rutherford, C, Tong, A, Levin, A, Narva, A, Wang, A, Ralph, A, Moffat, AM, Bell, B, Hemmelgarn, B, Schiller, B, Hawley, C, Perry, C, Wanner, C, Cukor, D, Perez, D, Cella, D, Harris, D, Johnson, D, Roer, D, Van Wyck, D, Wheeler, D, Deyhle, D, Gill, D, Schatell, D, Bavlovlenkov, E, Weinhandl, E, Caskey, F, Tentori, F, Sakkas, G, Saver, H, Wells, H, Wadee, J, Akbar, J, Carter, J, Flythe, J, Shen, J, Kusek, J, Gill, J, Beverly, J, Pinter, J, Johansen, K, Meyer, K, Lirtzman, L, Wagner-Weiner, L, Costabile, L, Jhamb, M, Tonelli, M, Ruospo, M, Howell, M, Bossola, M, Thomas, M, Mendez, N, Powe, N, Gedney, N, Rouse, N, Kaden, P, Kerr, P, Tugwell, P, Taylor, Q, Sand, R, Pecoits-Filho, R, Crowe, S, Gill, S, Jowsey-Gregoire, S, Fadem, S, McDonald, S, Weisbord, S, Palmer, S, Hedayati, SS, Harris, T, Hiemstra, TF, Muhammed, U, McNorton, V, Sikirica, V, Jha, V, Herrington, W, Van Biesen, W, Winkelmayer, W & Butt, Z 2018, '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, vol. 72, no. 1, pp. 104-112. https://doi.org/10.1053/j.ajkd.2017.12.018

TY - JOUR

T1 - Establishing a Core Outcome Measure for Fatigue in Patients on Hemodialysis

T2 - SONG-HD Fatigue Consensus workshop

AU - Ju, Angela

AU - Unruh, Mark

AU - Davison, Sara

AU - Dapueto, Juan

AU - Dew, Mary Amanda

AU - Fluck, Richard

AU - Germain, Michael

AU - Jassal, Sarbjit V.

AU - Obrador, Gregorio

AU - O'Donoghue, Donal

AU - Josephson, Michelle A.

AU - Craig, Jonathan C.

AU - Viecelli, Andrea

AU - O'Lone, Emma

AU - Hanson, Camilla S.

AU - Manns, Braden

AU - Sautenet, Benedicte

AU - Howell, Martin

AU - Reddy, Bharathi

AU - Wilkie, Caroline

AU - Rutherford, Claudia

AU - Tong, Allison

AU - Levin, Adeera

AU - Narva, Andrew

AU - Wang, Angela

AU - Ralph, Angelique

AU - Moffat, Annette Montalbano

AU - Bell, Barry

AU - Hemmelgarn, Brenda

AU - Schiller, Brigitte

AU - Hawley, Carmel

AU - Perry, Christen

AU - Wanner, Christoph

AU - Cukor, Daniel

AU - Perez, Daniel

AU - Cella, David

AU - Harris, David

AU - Johnson, David

AU - Roer, David

AU - Van Wyck, David

AU - Wheeler, David

AU - Deyhle, Deborah

AU - Gill, Derrick

AU - Schatell, Dori

AU - Bavlovlenkov, Elena

AU - Weinhandl, Eric

AU - Caskey, Fergus

AU - Tentori, Francesca

AU - Sakkas, Giorgos

AU - Saver, Harvey

AU - Wells, Harvey

AU - Wadee, James

AU - Akbar, Jamilah

AU - Carter, Jane

AU - Flythe, Jennifer

AU - Shen, Jenny

AU - Kusek, John

AU - Gill, John

AU - Beverly, Joyce

AU - Pinter, Jule

AU - Johansen, Kirsten

AU - Meyer, Klemens

AU - Lirtzman, Leonard

AU - Wagner-Weiner, Linda

AU - Costabile, Luigi

AU - Jhamb, Manisha

AU - Tonelli, Marcello

AU - Ruospo, Marinella

AU - Howell, Martin

AU - Bossola, Maurizio

AU - Thomas, Michael

AU - Mendez, Nadia

AU - Powe, Neil

AU - Gedney, Nieltje

AU - Rouse, Noah

AU - Kaden, Pamela

AU - Kerr, Peter

AU - Tugwell, Peter

AU - Taylor, Quinetta

AU - Sand, Rachel

AU - Pecoits-Filho, Roberto

AU - Crowe, Sally

AU - Gill, Sarah

AU - Jowsey-Gregoire, Sheila

AU - Fadem, Stephen

AU - McDonald, Stephen

AU - Weisbord, Steven

AU - Palmer, Suetonia

AU - Hedayati, S. Susan

AU - Harris, Tess

AU - Hiemstra, Thomas F.

AU - Muhammed, Uthma

AU - McNorton, Vanessa

AU - Sikirica, Vanja

AU - Jha, Vivek

AU - Herrington, William

AU - Van Biesen, Wim

AU - Winkelmayer, Wolfgang

AU - Butt, Zeeshan

PY - 2018/7/1

Y1 - 2018/7/1

N2 - 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.

AB - 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.

KW - Clinical trials

KW - consensus

KW - core outcome

KW - dialysis symptoms

KW - end-stage renal disease (ESRD)

KW - fatigue

KW - hemodialysis

KW - kidney disease

KW - life participation

KW - nephrology research

KW - outcome

KW - outcome measure

KW - patient-centered research

KW - patient-reported outcome (PRO)

KW - quality of life

KW - tiredness

UR - http://www.scopus.com/inward/record.url?scp=85044072824&partnerID=8YFLogxK

UR - http://purl.org/au-research/grants/NHMRC/1098815

UR - http://purl.org/au-research/grants/NHMRC/1092579

U2 - 10.1053/j.ajkd.2017.12.018

DO - 10.1053/j.ajkd.2017.12.018

M3 - Article

AN - SCOPUS:85044072824

SN - 0272-6386

VL - 72

SP - 104

EP - 112

JO - American Journal of Kidney Diseases

JF - American Journal of Kidney Diseases

IS - 1

Y2 - 19 November 2016 through 19 November 2016

ER -

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

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