1. Establishing Core Cardiovascular Outcome Measures for Trials in Hemodialysis: Report of an International Consensus Workshop
- Author
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Emma O'Lone, Andrea K. Viecelli, Jonathan C. Craig, Allison Tong, Benedicte Sautenet, William G. Herrington, Charles A. Herzog, Tazeen H. Jafar, Meg Jardine, Vera Krane, Adeera Levin, Jolanta Malyszko, Michael V. Rocco, Giovanni Strippoli, Marcello Tonelli, Angela Yee Moon Wang, Christoph Wanner, Faiez Zannad, Wolfgang C. Winkelmayer, David C. Wheeler, Braden Manns, Roberto Pecoits-Filho, Tess Harris, Wolfgang Winkelmayer, Chuck A. Herzog, Myra Kleinpeter, Angela Ju, Yeoungjee Cho, Talia Gutman, Amelie Bernier-Jean, Laura James, Lorraine Hamiwka, Alan Jardine, Amino Bello, Benedicte Stengel, Brigitte Schiller, David Johnson, Elena Bavlovlenkov, Fergus Caskey, Barbara Gillespie, Geoffrey Block, Hai An Phan, Hiddo Lambers Heerspink, Magdalena Madero, Marinella Ruospo, Mark Unruh, Maurice Laville, Nisha Bansal, Patrick Mark, P.J. Blankestijn, Prabir Roy-Chaudhury, Rachel Perlman, Rajiv Agarwal, Rajnish Mehrotra, Stephen Seliger, Tariq Shafi, Thomas Hiemstra, Vanita Jassal, Vlado Perkovic, Amanda Simplice, David White, Denise Eilers, Herbert Alexander, Yvonne Landry, Gennifer Landry, Caroline Wilkie, MethodS in Patients-centered outcomes and HEalth ResEarch (SPHERE), Université de Tours-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Nantes - UFR des Sciences Pharmaceutiques et Biologiques, Université de Nantes (UN)-Université de Nantes (UN), and Université de Tours (UT)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Nantes - UFR des Sciences Pharmaceutiques et Biologiques
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medicine.medical_specialty ,Consensus ,Internationality ,Health Personnel ,medicine.medical_treatment ,[SDV]Life Sciences [q-bio] ,Population ,030232 urology & nephrology ,Disease ,patient-centered outcome (PRO) ,outcomes ,core outcome set ,Outcome (game theory) ,Education ,Sudden cardiac death ,outcomes research ,03 medical and health sciences ,0302 clinical medicine ,Renal Dialysis ,Outcome Assessment, Health Care ,heart failure (HF) ,Humans ,Medicine ,030212 general & internal medicine ,Myocardial infarction ,Intensive care medicine ,education ,Societies, Medical ,myocardial infarction (MI) ,sudden cardiac death (SCD) ,Cause of death ,Hemodialysis (HD) ,Clinical Trials as Topic ,education.field_of_study ,business.industry ,cardiovascular disease (CVD) ,medicine.disease ,3. Good health ,Cardiovascular Diseases ,Nephrology ,end-stage renal disease (ESRD) ,trial design ,Hemodialysis ,Patient Participation ,Outcomes research ,business - Abstract
International audience; 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.
- Published
- 2020
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