TY - JOUR
T1 - Establishing Core Outcome Domains in Hemodialysis: Report of the Standardized Outcomes in Nephrology–Hemodialysis (SONG-HD) Consensus Workshop
AU - Tong, Allison
AU - Manns, Braden
AU - Hemmelgarn, Brenda
AU - Wheeler, David
AU - Evangelidis, Nicole
AU - Tugwell, Peter
AU - Crowe, Sally
AU - van Biesen, Wim
AU - Winkelmayer, Wolfgang
AU - O'Donoghue, Donal
AU - Tam-Tham, Helen
AU - Shen, Jenny
AU - Pinter, Jule
AU - Larkins, Nicholas
AU - Youssouf, Sajeda
AU - Mandayam, Sreedhar
AU - Ju, Angela
AU - Craig, Jonathan
PY - 2017/1/1
Y1 - 2017/1/1
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
UR - http://www.scopus.com/inward/record.url?scp=84998880943&partnerID=8YFLogxK
U2 - 10.1053/j.ajkd.2016.05.022
DO - 10.1053/j.ajkd.2016.05.022
M3 - Article
VL - 69
SP - 97
EP - 107
JO - American Journal of Kidney Diseases
JF - American Journal of Kidney Diseases
SN - 0272-6386
IS - 1
M1 - EDTL
ER -