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

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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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Overview and Context

The international SONG-HD consensus workshop was convened to elicit stakeholder feedback on the identification and implementation of a potential core outcome set for hemodialysis trials and other forms of research. The potential core outcomes are based on preliminary data and interim analysis from an international Delphi survey that was completed by patients, caregivers, health care providers, policymakers, and funders. Outcomes with a mean and median score ≥7 (defined as of critical

Overview

Themes arising from the workshop discussion on the identification and implementation of core outcomes in hemodialysis are described in the following section. For some themes, a brief explanation of SONG-HD principles and process has been included to provide context for the discussion. Illustrative quotations for each theme are provided in Table 1. Key recommendations of the consensus workshop are outlined in Box 1.

Broad inclusion of patients

Patient involvement is a fundamental principle underpinning the SONG-HD process.

Discussion

Overall, workshop participants and contributors supported the principle of establishing a set of core outcomes to optimize the relevance and value of research to guide decision making in hemodialysis. The SONG-HD process was deemed valuable in focusing attention on outcomes that were regarded as important across all stakeholder groups and in revealing important discrepancies in how outcomes were prioritized and conceptualized between patient/caregivers and health professionals. Workshop

Acknowledgements

The SONG-HD Workshop Investigators are as follows (United States unless otherwise indicated): Allan Collins, Hennepin Healthcare System Inc, University of Minnesota; Andrew Narva, NIH; Benedicte Sautenet, The University of Sydney, Australia; Billy Powell, Baylor College of Medicine; Brenda Hurd, Baylor College of Medicine; Brendan Barrett, Memorial University, Canada; Brigitte Schiller, Satellite Healthcare; Bruce Culleton, Baxter International; Carmel Hawley, University of Queensland, Princess

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Cited by (0)

Because an author of this article is an editor for AJKD, the peer-review and decision-making processes were handled entirely by an Associate Editor (Carmen A. Peralta, MD, MAS) who served as Acting Editor-in-Chief. Details of the journal’s procedures for potential editor conflicts are given in the Information for Authors & Journal Policies.

A complete list of the SONG-HD Investigators appears in the Acknowledgements.

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