TY - JOUR
T1 - Establishing Core Cardiovascular Outcome Measures for Trials in Hemodialysis
T2 - Report of an International Consensus Workshop
AU - O'Lone, Emma
AU - Viecelli, Andrea K.
AU - Craig, Jonathan C.
AU - Tong, Allison
AU - Sautenet, Benedicte
AU - Herrington, William G.
AU - Herzog, Charles A.
AU - Jafar, Tazeen H.
AU - Jardine, Meg
AU - Krane, Vera
AU - Levin, Adeera
AU - Malyszko, Jolanta
AU - Rocco, Michael V.
AU - Strippoli, Giovanni
AU - Tonelli, Marcello
AU - Wang, Angela Yee Moon
AU - Wanner, Christoph
AU - Zannad, Faiez
AU - Winkelmayer, Wolfgang C.
AU - Wheeler, David C.
AU - SONG-HD CVD Consensus Workshop Investigators
AU - Manns, Braden
AU - Pecoits-Filho, Roberto
AU - Harris, Tess
AU - Kleinpeter, Myra
AU - Ju, Angela
AU - Cho, Yeoungjee
AU - Gutman, Talia
AU - Bernier-Jean, Amelie
AU - James, Laura
AU - Hamiwka, Lorraine
AU - Jardine, Alan
AU - Bello, Amino
AU - Stengel, Benedicte
AU - Schiller, Brigitte
AU - Johnson, David
AU - Bavlovlenkov, Elena
AU - Caskey, Fergus
AU - Gillespie, Barbara
AU - Block, Geoffrey
AU - Phan, Hai An
AU - Heerspink, Hiddo Lambers
AU - Madero, Magdalena
AU - Ruospo, Marinella
AU - Unruh, Mark
AU - Laville, Maurice
AU - Bansal, Nisha
AU - Mark, Patrick
AU - Blankestijn, P. J.
AU - Roy-Chaudhury, Prabir
AU - Perlman, Rachel
AU - Agarwal, Rajiv
AU - Mehrotra, Rajnish
AU - Seliger, Stephen
AU - Shafi, Tariq
AU - Hiemstra, Thomas
AU - Jassal, Vanita
AU - Perkovic, Vlado
AU - Simplice, Amanda
AU - White, David
AU - Eilers, Denise
AU - Alexander, Herbert
AU - Landry, Yvonne
AU - Landry, Gennifer
AU - Wilkie, Caroline
PY - 2020/7
Y1 - 2020/7
N2 - 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.
AB - 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.
KW - cardiovascular disease (CVD)
KW - core outcome set
KW - end-stage renal disease (ESRD)
KW - heart failure (HF)
KW - Hemodialysis (HD)
KW - myocardial infarction (MI)
KW - outcomes
KW - outcomes research
KW - patient-centered outcome (PRO)
KW - sudden cardiac death (SCD)
KW - trial design
UR - http://www.scopus.com/inward/record.url?scp=85089527247&partnerID=8YFLogxK
UR - http://purl.org/au-research/grants/NHMRC/1098815
U2 - 10.1053/j.ajkd.2020.01.022
DO - 10.1053/j.ajkd.2020.01.022
M3 - Article
C2 - 32414662
AN - SCOPUS:85089527247
SN - 0272-6386
VL - 76
SP - 109
EP - 120
JO - American Journal of Kidney Diseases
JF - American Journal of Kidney Diseases
IS - 1
ER -
