Establishing Core Cardiovascular Outcome Measures for Trials in Hemodialysis: Report of an International Consensus Workshop

Cardiovascular disease (CVD) affects more than two-thirds of patients receiving hemodialysis and is the leading cause of death in this population, yet CVD outcomes are infrequently and inconsistently reported in trials in patients receiving hemodialysis. As part of the Standardised Outcomes in Nephrology-Haemodialysis (SONG-HD) initiative, we convened a consensus workshop to discuss the potential use of myocardial infarction and sudden cardiac death as core outcome measures for CVD for use in all trials in people receiving hemodialysis. Eight patients or caregivers and 46 health professionals from 15 countries discussed selection and implementation of the proposed core outcome measures. Five main themes were identified: capturing specific relevance to the hemodialysis population (acknowledging prevalence, risk, severity, unique symptomology, and pathophysiology), the dilemmas in using composite outcomes, addressing challenges in outcome definitions (establishing a common definition and addressing uncertainty in the utility of biomarkers in hemodialysis), selecting a meaningful metric for decision making (to facilitate comparison across trials), and enabling and incentivizing implementation (by ensuring that cardiologists are involved in the development and integration of the outcome measure into registries, trial design, and reporting guidelines). Based on these themes, participants supported the use of myocardial infarction and sudden cardiac death as core outcome measures of CVD to be reported in all hemodialysis trials.

Contributors

EmmaO'Lone12Andrea K.Viecelli34Jonathan C.Craig5AllisonTong12BenedicteSautenet678William G.Herrington9Charles A.Herzog10Tazeen H.Jafar111213MegJardine1415VeraKrane16AdeeraLevin17JolantaMalyszko18Michael V.Rocco19GiovanniStrippoli12202122MarcelloTonelli23Angela Yee MoonWang24ChristophWanner16FaiezZannad25Wolfgang C.Winkelmayer26David C.Wheeler27on behalf of the
SONG-HD CVD Consensus Workshop Investigators

Publication

Journal: American Journal of Kidney Diseases
Volume: 76
Issue: 1
Pages: 109 - 120
Year: 2020
DOI: 10.1053/j.ajkd.2020.01.022

Further Study Information

Current Stage: Completed
Date:
Funding source(s):


Health Area

Disease Category: Kidney disease

Disease Name: Chronic kidney disease

Target Population

Age Range: Unknown

Sex: Either

Nature of Intervention: Procedure

Stakeholders Involved

- Clinical experts
- Consumers (caregivers)
- Consumers (patients)

Study Type

- COS for clinical trials or clinical research
- Recommendations for outcome measures (measurement/how)

Method(s)

- Semi structured discussion

Linked Studies

    No related studies


Related Links

    No related links