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 & 60 others 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, Rene Van Den Dorpel, Reva Parks

Research output: Contribution to journalArticle

58 Citations (Scopus)

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.

LanguageEnglish
Pages97-107
Number of pages11
JournalAmerican Journal of Kidney Diseases
Volume69
Issue number1
DOIs
Publication statusPublished - 1 Jan 2017

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

ASJC Scopus subject areas

  • Nephrology

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