Establishing Core Outcome Domains in Hemodialysis: Report of the Standardized Outcomes in Nephrology–Hemodialysis (SONG-HD) Consensus Workshop

Allison Tong; Braden Manns; Brenda Hemmelgarn; David C. Wheeler; Nicole Evangelidis; Peter Tugwell; Sally Crowe; Wim Van Biesen; Wolfgang C. Winkelmayer; Donal O'Donoghue; Helen Tam-Tham; Jenny I. Shen; Jule Pinter; Nicholas Larkins; Sajeda Youssouf; Sreedhar Mandayam; Angela Ju; Jonathan C. Craig; Allan Collins; Andrew Narva; Benedicte Sautenet; Billy Powell; Brenda Hurd; Brendan Barrett; Brigitte Schiller; Bruce Culleton; Carmel Hawley; Carol Pollock; Charmaine Lok; Christoph Wanner; Christopher Chan; Daniel Weiner; David Harris; David Johnson; David Rosenbloom; Dena Rifkin; Deshia Bookman; Edwina Brown; Elena Bavlovlenkov; Francesca Tentori; Jack Williams; Jane Schell; Jennifer Flythe; Joachim Ix; Jochen Raimann; Joel Andress; John Agar; John Daugirdas; John Gill; John Kusek; Kevan Polkinghorne; Kevin Abbott; Len Usyvat; Mahesh Krishnan; Marcello Tonelli; Mark Marshall; Martin Gallagher; Michael Germain; Michael Walsh; Michael Zappitelli; Michelle Josephson; Nilka Rios Burrows; Orlando Houston; Peter Kerr; Peter Kotanko; Prabir Roy-Chaudhury; Rachael Morton; Raj Mehrotra; Rene van den Dorpel; Rita Suri; Ron Wald; Ronke Apata; Shalia Gibson; Sharrilyn Evered; Stephen Fadem; Stephen McDonald; Steve Holt; Terence Kee; Braden Manns; Brenda Hemmelgarn; David Wheeler; Tess Harris; Wolfgang Winkelmayer; Allison Tong; Andrew Narva; Billy Powell; Brenda Hurd; Brendan Barrett; Brigitte Schiller; Bruce Culleton; Carmel Hawley; Charmaine Lok; Christoph Wanner; Daniel Weiner; David Johnson; David Rosenbloom; Dena Rifkin; Deshia Bookman; Donal O'Donoghue; Edwina Brown; Elena Bavlovlenkov; Helen Tam-Tham; Jack Williams; Jane Schell; Jenny Shen; Jochen Raimann; John Daugirdas; John Kusek; Jule Pinter; Kevan Polkinghorne; Kevin Abbott; Mark Marshall; Martin Gallagher; Michael Walsh; Michael Zappitelli; Michelle Josephson; Nicholas Larkins; Nicole Evangelidis; Orlando Houston; Peter Kerr; Prabir Roy-Chaudhury; Rachael Morton; Raj Mehrotra; Rene Van Den Dorpel; Rita Suri; Reva Parks; Ron Wald; Ronke Apata; Sajeda Youssouf; Shalia Gibson; Sreedhar Mandayam; Stephen Fadem; Steve Holt

doi:10.1053/j.ajkd.2016.05.022

Establishing Core Outcome Domains in Hemodialysis: Report of the Standardized Outcomes in Nephrology–Hemodialysis (SONG-HD) Consensus Workshop

Allison Tong, Braden Manns, Brenda Hemmelgarn, David C. Wheeler, Nicole Evangelidis, Peter Tugwell, Sally Crowe, Wim Van Biesen, Wolfgang C. Winkelmayer, Donal O'Donoghue, Helen Tam-Tham, Jenny I. Shen, Jule Pinter, Nicholas Larkins, Sajeda Youssouf, Sreedhar Mandayam, Angela Ju, Jonathan C. Craig, Allan Collins, Andrew NarvaBenedicte Sautenet, Billy Powell, Brenda Hurd, Brendan Barrett, Brigitte Schiller, Bruce Culleton, Carmel Hawley, Carol Pollock, Charmaine Lok, Christoph Wanner, Christopher Chan, Daniel Weiner, David Harris, David Johnson, David Rosenbloom, Dena Rifkin, Deshia Bookman, Edwina Brown, Elena Bavlovlenkov, Francesca Tentori, Jack Williams, Jane Schell, Jennifer Flythe, Joachim Ix, Jochen Raimann, Joel Andress, John Agar, John Daugirdas, John Gill, John Kusek, Kevan Polkinghorne, Kevin Abbott, Len Usyvat, Mahesh Krishnan, Marcello Tonelli, Mark Marshall, Martin Gallagher, Michael Germain, Michael Walsh, Michael Zappitelli, Michelle Josephson, Nilka Rios Burrows, Orlando Houston, Peter Kerr, Peter Kotanko, Prabir Roy-Chaudhury, Rachael Morton, Raj Mehrotra, Rene van den Dorpel, Rita Suri, Ron Wald, Ronke Apata, Shalia Gibson, Sharrilyn Evered, Stephen Fadem, Stephen McDonald, Steve Holt, Terence Kee, Braden Manns, Brenda Hemmelgarn, David Wheeler, Tess Harris, Wolfgang Winkelmayer, Allison Tong, Andrew Narva, Billy Powell, Brenda Hurd, Brendan Barrett, Brigitte Schiller, Bruce Culleton, Carmel Hawley, Charmaine Lok, Christoph Wanner, Daniel Weiner, David Johnson, David Rosenbloom, Dena Rifkin, Deshia Bookman, Donal O'Donoghue, Edwina Brown, Elena Bavlovlenkov, Helen Tam-Tham, Jack Williams, Jane Schell, Jenny Shen, Jochen Raimann, John Daugirdas, John Kusek, Jule Pinter, Kevan Polkinghorne, Kevin Abbott, Mark Marshall, Martin Gallagher, Michael Walsh, Michael Zappitelli, Michelle Josephson, Nicholas Larkins, Nicole Evangelidis, Orlando Houston, Peter Kerr, Prabir Roy-Chaudhury, Rachael Morton, Raj Mehrotra, Rene Van Den Dorpel, Rita Suri, Reva Parks, Ron Wald, Ronke Apata, Sajeda Youssouf, Shalia Gibson, Sreedhar Mandayam, Stephen Fadem, Steve Holt

Medicine - Renal and Hypertension Division

Research output: Contribution to journal › Article › peer-review

159 Scopus citations

Abstract

Evidence-informed decision making in clinical care and policy in nephrology is undermined by trials that selectively report a large number of heterogeneous outcomes, many of which are not patient centered. The Standardized Outcomes in Nephrology−Hemodialysis (SONG-HD) Initiative convened an international consensus workshop on November 7, 2015, to discuss the identification and implementation of a potential core outcome set for all trials in hemodialysis. The purpose of this article is to report qualitative analyses of the workshop discussions, describing the key aspects to consider when establishing core outcomes in trials involving patients on hemodialysis therapy. Key stakeholders including 8 patients/caregivers and 47 health professionals (nephrologists, policymakers, industry, and researchers) attended the workshop. Attendees suggested that identifying core outcomes required equitable stakeholder engagement to ensure relevance across patient populations, flexibility to consider evolving priorities over time, deconstruction of language and meaning for conceptual consistency and clarity, understanding of potential overlap and associations between outcomes, and an assessment of applicability to the range of interventions in hemodialysis. For implementation, they proposed that core outcomes must have simple, inexpensive, and validated outcome measures that could be used in clinical care (quality indicators) and trials (including pragmatic trials) and endorsement by regulatory agencies. Integrating these recommendations may foster acceptance and optimize the uptake and translation of core outcomes in hemodialysis, leading to more informative research, for better treatment and improved patient outcomes.

Original language	English (US)
Pages (from-to)	97-107
Number of pages	11
Journal	American Journal of Kidney Diseases
Volume	69
Issue number	1
DOIs	https://doi.org/10.1053/j.ajkd.2016.05.022
State	Published - Jan 1 2017

Bibliographical note

Publisher Copyright:
© 2016 National Kidney Foundation, Inc.

Keywords

Clinical research
consensus
core outcome set
end-stage renal disease (ESRD)
hemodialysis
nephrology research
outcomes
patient-centered care
research priorities
research quality
standardized reporting
workshop report

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

Publisher link

10.1053/j.ajkd.2016.05.022

http://europepmc.org/articles/pmc5369351

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Tong, A., Manns, B., Hemmelgarn, B., Wheeler, D. C., Evangelidis, N., Tugwell, P., Crowe, S., Van Biesen, W., Winkelmayer, W. C., O'Donoghue, D., Tam-Tham, H., Shen, J. I., Pinter, J., Larkins, N., Youssouf, S., Mandayam, S., Ju, A., Craig, J. C., Collins, A., ... Holt, S. (2017). Establishing Core Outcome Domains in Hemodialysis: Report of the Standardized Outcomes in Nephrology–Hemodialysis (SONG-HD) Consensus Workshop. American Journal of Kidney Diseases, 69(1), 97-107. https://doi.org/10.1053/j.ajkd.2016.05.022

Tong, A, Manns, B, Hemmelgarn, B, Wheeler, DC, Evangelidis, N, Tugwell, P, Crowe, S, Van Biesen, W, Winkelmayer, WC, O'Donoghue, D, Tam-Tham, H, Shen, JI, Pinter, J, Larkins, N, Youssouf, S, Mandayam, S, Ju, A, Craig, JC, Collins, A, Narva, A, Sautenet, B, Powell, B, Hurd, B, Barrett, B, Schiller, B, Culleton, B, Hawley, C, Pollock, C, Lok, C, Wanner, C, Chan, C, Weiner, D, Harris, D, Johnson, D, Rosenbloom, D, Rifkin, D, Bookman, D, Brown, E, Bavlovlenkov, E, Tentori, F, Williams, J, Schell, J, Flythe, J, Ix, J, Raimann, J, Andress, J, Agar, J, Daugirdas, J, Gill, J, Kusek, J, Polkinghorne, K, Abbott, K, Usyvat, L, Krishnan, M, Tonelli, M, Marshall, M, Gallagher, M, Germain, M, Walsh, M, Zappitelli, M, Josephson, M, Burrows, NR, Houston, O, Kerr, P, Kotanko, P, Roy-Chaudhury, P, Morton, R, Mehrotra, R, Dorpel, RVD, Suri, R, Wald, R, Apata, R, Gibson, S, Evered, S, Fadem, S, McDonald, S, Holt, S, Kee, T, Manns, B, Hemmelgarn, B, Wheeler, D, Harris, T, Winkelmayer, W, Tong, A, Narva, A, Powell, B, Hurd, B, Barrett, B, Schiller, B, Culleton, B, Hawley, C, Lok, C, Wanner, C, Weiner, D, Johnson, D, Rosenbloom, D, Rifkin, D, Bookman, D, O'Donoghue, D, Brown, E, Bavlovlenkov, E, Tam-Tham, H, Williams, J, Schell, J, Shen, J, Raimann, J, Daugirdas, J, Kusek, J, Pinter, J, Polkinghorne, K, Abbott, K, Marshall, M, Gallagher, M, Walsh, M, Zappitelli, M, Josephson, M, Larkins, N, Evangelidis, N, Houston, O, Kerr, P, Roy-Chaudhury, P, Morton, R, Mehrotra, R, Van Den Dorpel, R, Suri, R, Parks, R, Wald, R, Apata, R, Youssouf, S, Gibson, S, Mandayam, S, Fadem, S & Holt, S 2017, 'Establishing Core Outcome Domains in Hemodialysis: Report of the Standardized Outcomes in Nephrology–Hemodialysis (SONG-HD) Consensus Workshop', American Journal of Kidney Diseases, vol. 69, no. 1, pp. 97-107. https://doi.org/10.1053/j.ajkd.2016.05.022

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title = "Establishing Core Outcome Domains in Hemodialysis: Report of the Standardized Outcomes in Nephrology–Hemodialysis (SONG-HD) Consensus Workshop",

abstract = "Evidence-informed decision making in clinical care and policy in nephrology is undermined by trials that selectively report a large number of heterogeneous outcomes, many of which are not patient centered. The Standardized Outcomes in Nephrology−Hemodialysis (SONG-HD) Initiative convened an international consensus workshop on November 7, 2015, to discuss the identification and implementation of a potential core outcome set for all trials in hemodialysis. The purpose of this article is to report qualitative analyses of the workshop discussions, describing the key aspects to consider when establishing core outcomes in trials involving patients on hemodialysis therapy. Key stakeholders including 8 patients/caregivers and 47 health professionals (nephrologists, policymakers, industry, and researchers) attended the workshop. Attendees suggested that identifying core outcomes required equitable stakeholder engagement to ensure relevance across patient populations, flexibility to consider evolving priorities over time, deconstruction of language and meaning for conceptual consistency and clarity, understanding of potential overlap and associations between outcomes, and an assessment of applicability to the range of interventions in hemodialysis. For implementation, they proposed that core outcomes must have simple, inexpensive, and validated outcome measures that could be used in clinical care (quality indicators) and trials (including pragmatic trials) and endorsement by regulatory agencies. Integrating these recommendations may foster acceptance and optimize the uptake and translation of core outcomes in hemodialysis, leading to more informative research, for better treatment and improved patient outcomes.",

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note = "Publisher Copyright: {\textcopyright} 2016 National Kidney Foundation, Inc.",

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doi = "10.1053/j.ajkd.2016.05.022",

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AU - Bookman, Deshia

AU - O'Donoghue, Donal

AU - Brown, Edwina

AU - Bavlovlenkov, Elena

AU - Tam-Tham, Helen

AU - Williams, Jack

AU - Schell, Jane

AU - Shen, Jenny

AU - Raimann, Jochen

AU - Daugirdas, John

AU - Kusek, John

AU - Pinter, Jule

AU - Polkinghorne, Kevan

AU - Abbott, Kevin

AU - Marshall, Mark

AU - Gallagher, Martin

AU - Walsh, Michael

AU - Zappitelli, Michael

AU - Josephson, Michelle

AU - Larkins, Nicholas

AU - Evangelidis, Nicole

AU - Houston, Orlando

AU - Kerr, Peter

AU - Roy-Chaudhury, Prabir

AU - Morton, Rachael

AU - Mehrotra, Raj

AU - Van Den Dorpel, Rene

AU - Suri, Rita

AU - Parks, Reva

AU - Wald, Ron

AU - Apata, Ronke

AU - Youssouf, Sajeda

AU - Gibson, Shalia

AU - Mandayam, Sreedhar

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AU - Holt, Steve

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N2 - Evidence-informed decision making in clinical care and policy in nephrology is undermined by trials that selectively report a large number of heterogeneous outcomes, many of which are not patient centered. The Standardized Outcomes in Nephrology−Hemodialysis (SONG-HD) Initiative convened an international consensus workshop on November 7, 2015, to discuss the identification and implementation of a potential core outcome set for all trials in hemodialysis. The purpose of this article is to report qualitative analyses of the workshop discussions, describing the key aspects to consider when establishing core outcomes in trials involving patients on hemodialysis therapy. Key stakeholders including 8 patients/caregivers and 47 health professionals (nephrologists, policymakers, industry, and researchers) attended the workshop. Attendees suggested that identifying core outcomes required equitable stakeholder engagement to ensure relevance across patient populations, flexibility to consider evolving priorities over time, deconstruction of language and meaning for conceptual consistency and clarity, understanding of potential overlap and associations between outcomes, and an assessment of applicability to the range of interventions in hemodialysis. For implementation, they proposed that core outcomes must have simple, inexpensive, and validated outcome measures that could be used in clinical care (quality indicators) and trials (including pragmatic trials) and endorsement by regulatory agencies. Integrating these recommendations may foster acceptance and optimize the uptake and translation of core outcomes in hemodialysis, leading to more informative research, for better treatment and improved patient outcomes.

AB - Evidence-informed decision making in clinical care and policy in nephrology is undermined by trials that selectively report a large number of heterogeneous outcomes, many of which are not patient centered. The Standardized Outcomes in Nephrology−Hemodialysis (SONG-HD) Initiative convened an international consensus workshop on November 7, 2015, to discuss the identification and implementation of a potential core outcome set for all trials in hemodialysis. The purpose of this article is to report qualitative analyses of the workshop discussions, describing the key aspects to consider when establishing core outcomes in trials involving patients on hemodialysis therapy. Key stakeholders including 8 patients/caregivers and 47 health professionals (nephrologists, policymakers, industry, and researchers) attended the workshop. Attendees suggested that identifying core outcomes required equitable stakeholder engagement to ensure relevance across patient populations, flexibility to consider evolving priorities over time, deconstruction of language and meaning for conceptual consistency and clarity, understanding of potential overlap and associations between outcomes, and an assessment of applicability to the range of interventions in hemodialysis. For implementation, they proposed that core outcomes must have simple, inexpensive, and validated outcome measures that could be used in clinical care (quality indicators) and trials (including pragmatic trials) and endorsement by regulatory agencies. Integrating these recommendations may foster acceptance and optimize the uptake and translation of core outcomes in hemodialysis, leading to more informative research, for better treatment and improved patient outcomes.

KW - Clinical research

KW - consensus

KW - core outcome set

KW - end-stage renal disease (ESRD)

KW - hemodialysis

KW - nephrology research

KW - outcomes

KW - patient-centered care

KW - research priorities

KW - research quality

KW - standardized reporting

KW - workshop report

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DO - 10.1053/j.ajkd.2016.05.022

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AN - SCOPUS:84998880943

SN - 0272-6386

VL - 69

SP - 97

EP - 107

JO - American Journal of Kidney Diseases

JF - American Journal of Kidney Diseases

IS - 1

ER -

Establishing Core Outcome Domains in Hemodialysis: Report of the Standardized Outcomes in Nephrology–Hemodialysis (SONG-HD) Consensus Workshop

Abstract

Bibliographical note

Keywords

UN SDGs

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