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

Emma O'Lone1, Andrea K Viecelli2, Jonathan C Craig3

  • 1Sydney School of Public Health, The University of Sydney, Sydney, Australia; Centre for Kidney Research, The Children's Hospital at Westmead, Sydney, Australia.

American Journal of Kidney Diseases : the Official Journal of the National Kidney Foundation
|May 17, 2020
PubMed

Insights

Cardiovascular disease (CVD) is a major concern for hemodialysis patients. Myocardial infarction and sudden cardiac death are now recommended as core outcome measures for CVD in all hemodialysis trials.

Area of Science:

  • Nephrology
  • Cardiology
  • Clinical Trials

Background:

  • Cardiovascular disease (CVD) is the leading cause of mortality in patients undergoing hemodialysis, affecting over two-thirds of this population.
  • Reporting of CVD outcomes in clinical trials for hemodialysis patients is inconsistent and infrequent, hindering comparative analysis and evidence synthesis.

Purpose of the Study:

  • To establish standardized core outcome measures for cardiovascular disease (CVD) in hemodialysis trials.
  • To address the need for consistent reporting of CVD events in clinical research involving patients on hemodialysis.

Main Methods:

  • A consensus workshop was convened as part of the Standardised Outcomes in Nephrology-Haemodialysis (SONG-HD) initiative.
  • Participants included eight patients/caregivers and 46 health professionals from 15 countries.
  • Discussions focused on the selection and implementation of myocardial infarction and sudden cardiac death as core outcome measures.

Main Results:

  • Five key themes emerged: relevance to the hemodialysis population, challenges with composite outcomes, defining outcomes (including biomarker utility), selecting meaningful metrics, and implementation strategies.
  • Participants reached a consensus to support the use of myocardial infarction and sudden cardiac death as core outcome measures for CVD.

Conclusions:

  • Myocardial infarction and sudden cardiac death are recommended as core outcome measures for cardiovascular disease in all future hemodialysis trials.
  • Standardized reporting of these outcomes will improve the quality and comparability of research in this vulnerable patient group.

Keywords:
Hemodialysis (HD)cardiovascular disease (CVD)core outcome setend-stage renal disease (ESRD)heart failure (HF)myocardial infarction (MI)outcomesoutcomes researchpatient-centered outcome (PRO)sudden cardiac death (SCD)trial design

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