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. 2017 Jan;69(1):97-107.
doi: 10.1053/j.ajkd.2016.05.022. Epub 2016 Aug 3.

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

Allison Tong  1 , Braden Manns  2 , Brenda Hemmelgarn  2 , David C Wheeler  3 , Nicole Evangelidis  4 , Peter Tugwell  5 , Sally Crowe  6 , Wim Van Biesen  7 , Wolfgang C Winkelmayer  8 , Donal O'Donoghue  9 , Helen Tam-Tham  2 , Jenny I Shen  10 , Jule Pinter  4 , Nicholas Larkins  4 , Sajeda Youssouf  9 , Sreedhar Mandayam  8 , Angela Ju  4 , Jonathan C Craig  4 ; SONG-HD Investigators
Collaborators, Affiliations

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

Allison Tong et al. Am J Kidney Dis. 2017 Jan.

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.

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.

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Conflict of interest statement

Financial Disclosure: The authors declare that they have no other relevant financial interests.

Figures

Figure 1
Figure 1
Core outcomes
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