Special Report
Report of the Standardized Outcomes in Nephrology–Hemodialysis (SONG-HD) Consensus Workshop on Establishing a Core Outcome Measure for Hemodialysis Vascular Access

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Vascular access outcomes in hemodialysis are critically important for patients and clinicians, but frequently are neither patient relevant nor measured consistently in randomized trials. A Standardized Outcomes in Nephrology–Hemodialysis (SONG-HD) consensus workshop was convened to discuss the development of a core outcome measure for vascular access. 13 patients/caregivers and 46 professionals (clinicians, policy makers, industry representatives, and researchers) attended. Participants advocated for vascular access function to be a core outcome based on the broad applicability of function regardless of access type, involvement of a multidisciplinary team in achieving a functioning access, and the impact of access function on quality of life, survival, and other access-related outcomes. A core outcome measure for vascular access required demonstrable feasibility for implementation across different clinical and trial settings. Participants advocated for a practical and flexible outcome measure with a simple actionable definition. Integrating patients’ values and preferences was warranted to enhance the relevance of the measure. Proposed outcome measures for function included “uninterrupted use of the access without the need for interventions” and “ability to receive prescribed dialysis,” but not “access blood flow,” which was deemed too expensive and unreliable. These recommendations will inform the definition and implementation of a core outcome measure for vascular access function in hemodialysis trials.

Section snippets

Background

A functioning vascular access is a lifeline for patients requiring hemodialysis (HD), but has a high risk of complications.1 Vascular access complications account for approximately 20% to 30% of hospital admissions for patients on HD and incur substantial health care costs.2, 3 One in every 2 arteriovenous fistulas or grafts will fail to function within the first year of creation and necessitate further interventions for problems such as inadequate maturation, stenosis, or thrombosis.4, 5, 6, 7

Context and Scope

The international SONG-HD vascular access consensus workshop was convened in Chicago during the American Society of Nephrology Kidney Week Conference in 2016 for stakeholders to discuss the identification and implementation of a core outcome measure for vascular access to be reported in all trials in HD. The top prioritized outcomes were vascular access function and infection based on a systematic review and interim results from an international survey on vascular access outcomes that was

Summary of Workshop Discussion

Overall, we identified 5 themes from the discussion: (1) capturing the broad applicability of function, (2) emphasizing experiential relevance and severity, (3) demonstrating feasibility of implementation, (4) ensuring robustness and validity, and (5) integrating patients’ values and preferences. Illustrative quotations for each theme are shown in Box 1 and contributions from breakout groups to the respective themes are listed in Table S2. Possible outcome measures discussed during the workshop

Discussion

Access function is highly relevant, important, and appropriate as the core outcome for vascular access because of its applicability to all access types, impact on quality of life and survival of patients, and representation of a multidisciplinary team effort. It encapsulates other important aspects of a vascular access, such as the ability to cannulate and receive adequate dialysis, and has implications on potential complications, such as pain, hospitalization for access procedures, or access

Acknowledgements

The following people attended the SONG-HD vascular access consensus workshop (further information on role and affiliation provided in Table S1): Alison Mayers, Allison Tong (facilitator), Andrea Viecelli (facilitator), Angela Ju (co-facilitator), Angela Wang, Anna Porter, Barry Bell, Benedicte Sautenent (co-facilitator), Bharathi Reddy, Braden Manns (facilitator), Camilla Hanson (co-facilitator), Carmel Hawley (facilitator), Charmaine Lok (co-facilitator), David Ennis, David Johnson

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  • Cited by (57)

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    Complete author and article information (including a list of the SONG-HD Vascular Access Workshop Investigators) provided before references.

    The Standardized Outcomes in Nephrology–Hemodialysis (SONG-HD) Vascular Access Workshop Investigators: Health Professionals: Adeera Levin, University of British Columbia, Canada; Allison Tong, University of Sydney, Australia; Andrea Viecelli, University of Queensland, Australia; Angela Ju, University of Sydney, Australia; Angela Wang, Queen Mary Hospital, University of Hong Kong, Hong Kong; Anna Porter, University of Illinois at Chicago, United States; Benedicte Sautenent, University Francois Rabelais, France; Bharathi Reddy, University of Chicago, United States; Braden Manns, University of Calgary, Canada; Brenda Hemmelgarn, University of Calgary, Canada; Brigitte Schiller, Satellite Healthcare, United States; Camilla Hanson, University of Sydney, Australia; Carmel Hawley, University of Queensland, Australia; Charmaine Lok, University of Toronto, Canada; David Wheeler, University College London, United Kingdom; David Harris, Westmead Hospital, Australia; David Johnson, University of Queensland, Australia; Dori Schatell, Medical Education Institute, United States; Eduardo Lacson Jr, Tufts University, United States; Elena Bavlovlenkov, Centers for Medicare & Medicaid Services, United States; Emma O'Lone, University of Sydney, Australia; Eric Chemla, St George's University NHS Foundation Trust, United Kingdom; Fergus Caskey, University of Bristol, United Kingdom; Giovanni Strippoli, University of Bari, Italy; Harold Feldman, University of Pennsylvania, United States; Ibironke Apata, Centers for Disease Control and Prevention; United States; Jan Tordoir, Maastricht University, Netherlands; Jennifer Flythe, University of North Carolina, United States; John Gill, University of British Columbia, Canada; John Kusek, National Institutes of Health, United States; Jonathan Craig, University of Sydney, Australia; Kevan Polkinghorne, Monash University, Australia; Kevin Abbott, National Institutes of Health, United States; Lai-Seong Hooi, Hospital Sultanah Aminah, Malaysia; Laura Dember, University of Pennsylvania, United States; Li Zuo, Peking University People's Hospital, China; Lilia Cervantes, University of Colorado, United States; Louise Moist, London Health Science Centre, Canada; Lynn Poole, United States; Marcello Tonelli, University of Calgary, Canada; Martin Howell, University of Sydney, Australia; Maurizio Gallieni, University of Milano, Italy; Meghan Elliot, University of Toronto, Canada; Michael Klusmeyer, Satellite Healthcare, United States; Michelle Josephson, University of Chicago, United States; Michelle Robbin, University of Alabama, United States; Miguel Riella, Pontificia Universidade Católica do Paraná, Brazil; Nicole Evangelidis, The University of Sydney, Australia; Peter Tugwell, University of Ottawa, Canada; Peter Kerr, Monash University, Australia; Pietro Ravani, University of Calgary, Canada; Prabir Roy-Chaudhury, University of Arizona, United States; Rajnish Mehrotra, University of Washington, United States; Raymond Vanholder, Ghent University, Belgium; Robert Quinn, University of Calgary, Canada; Roberto Pecoits-Filho, Pontificia Universidade Catolica do Paraná, Brazil; Sally Crowe, Crowe Associates Ltd, United Kingdom; Sharrilyn Evered, Centers for Medicare & Medicaid Services, United States; Stephan Segerer, University of Zurich, Switzerland; Stephen Fadem, Baylor College of Medicine, United States; Stephen McDonald, University of Adelaide, Australia; Stuart Sprague, Northshore University, United States; Suetonia Palmer, University of Otago, New Zealand; Tammy Poma, University of Chicago, United States; Timmy Lee, Veterans Affairs Medical Center, Birmingham, United States; Tushar Vachharajani, W.G. (Bill) Hefner Veterans Affairs Medical Center, Salisbury, United States; Vanja Sikirica, GlaxoSmithKline, United States; Vivek Jha, The George Institute for Global Health, India; Wim van Biesen, University of Ghent, Belgium; Wolfgang Winkelmayer, Baylor College of Medicine, United States. Patients/Caregivers (all from Chicago unless otherwise indicated): Alison Mayers, Barry Bell, Jane Carter, Kimberly Hardy, Mary Ennis, Metarose Johnson, Noah Rouse Jr, Sarita Wright, Tess Harris (London), Uthman Muhammad, Vanessa McNorton, David Mayers, David Ennis.

    Authors’ Full Names and Academic Degrees: Andrea K. Viecelli, MD, Allison Tong, PhD, Emma O’Lone, MD, Angela Ju, BPsych (Hons), Camilla S. Hanson, BPsych (Hons), Benedicte Sautenet, PhD, Jonathan C. Craig, PhD, Braden Manns, MD, MSc, Martin Howell, PhD, Eric Chemla, MD, Lai-Seong Hooi, MD, David W. Johnson, PhD, Timmy Lee, PhD, Charmaine E. Lok, MSc, Kevan R. Polkinghorne, PhD, Robert R. Quinn, PhD, Tushar Vachharajani, MD, Raymond Vanholder, PhD, Li Zuo, PhD, and Carmel M. Hawley, MMed Sci.

    Support: The workshop (and SONG-HD) is funded by the National Health and Medical Research Council (NHMRC; 1098815). Dr Tong is supported by an NHMRC Fellowship (1106716). Dr Viecelli receives grant support from the NHMRC Medical Postgraduate Scholarship (1114539) and the Royal Australasian College of Physicians (Jacquot NHMRC Award for Excellence). Dr O’Lone receives support from the NHMRC Medical Postgraduate Scholarship (1114189), and Dr Johnson is supported by an NHMRC Practitioner Fellowship (1117534). The funding organization had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; or preparation, review, or approval of the manuscript.

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

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