Original InvestigationDeveloping a Set of Core Outcomes for Trials in Hemodialysis: An International Delphi Survey
Section snippets
Study Design
The Delphi method is a technique for achieving consensus among a panel of experts. This process involves sequential surveys, typically conducted over 3 rounds and answered anonymously, and gives equal influence to all who participate. It was first developed by the RAND Corporation in the 1950s25 and has since been increasingly used as a valid approach to develop consensus-based core outcomes for clinical trials in various medical specialty areas.10, 22, 26, 27, 28 The SONG-HD Delphi process is
Participant Characteristics
In total, 1,181 people from 73 countries participated in round 1 of the Delphi survey, including 202 (17%) patients/caregivers and 979 (83%) health professionals. Round 2 included 165 (17%) patients/caregivers and 784 (83%) health professionals from 63 countries. In the third and final round, 150 (18%) patients/caregivers and 688 (82%) health professionals participated. The full survey completion rate was 71%. Participant characteristics are provided in Tables 1 and 2.
In round 3, of the 150
Discussion
The highest priority outcomes shared among patients/caregivers and health professionals were vascular access problems, dialysis adequacy, fatigue, CVD, and mortality. Overall, most of these reflect common and high-impact outcomes in the context of HD, which have remained as major challenges in providing care for patients on HD therapy. Frequently reported biochemical outcomes in HD trials, such as phosphate, calcium, and parathyroid hormone levels, were consistently rated to be of lower
Acknowledgements
We thank the following organizations for their support: International: Cochrane Kidney and Transplant, International Society of Nephrology, KDIGO (Kidney Disease: Improving Global Outcomes), PKD International; Australia/New Zealand: Australian and New Zealand Society of Nephrology, Australian Kidney Trials Network, Christchurch Kidney Society, Kidney Health Australia, Kidney Health Australia–Caring for Australasians with Renal Impairment Guidelines, Kidney Health New Zealand, Renal Society of
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Because an author of this article was an editor for AJKD at the time the manuscript was submitted, the peer-review and decision-making processes were handled entirely by an Associate Editor (Amit X. Garg, MD, MA, FRCPC, PhD) 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.
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A list of the SONG-HD initiative investigators is available at www.songinitiative.org.