02676nas a2200337   4500000000100000008004100001100002100042700001800063700001900081700001700100700001700117700002200134700002300156700001800179700001600197700001900213700002500232700001900257700001500276700001600291700002100307700002000328700002200348700001400370700002600384245014800410300001100558490000700569520174800576022001402324       2017                            d1 aO'Donoghue Donal1 aWheeler David1 aCraig Jonathan1 aTong Allison1 aManns Braden1 aHemmelgarn Brenda1 aEvangelidis Nicole1 aTugwell Peter1 aCrowe Sally1 aVan Biesen Wim1 aWinkelmayer Wolfgang1 aTam-Tham Helen1 aShen Jenny1 aPinter Jule1 aLarkins Nicholas1 aYoussouf Sajeda1 aMandayam Sreedhar1 aJu Angela1 aSONG-HD Investigators00aEstablishing Core Outcome Domains in Hemodialysis: Report of the Standardized Outcomes in Nephrology-Hemodialysis (SONG-HD) Consensus Workshop.  a97-1070 v693 a<p>
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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