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

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Establishing Core Cardiovascular Outcome Measures for Trials in Hemodialysis: Report of an International Consensus Workshop
 
SONG-HD CVD Consensus Workshop Investigators
(2020) American Journal of Kidney Diseases, volume 76, issue 1, pp. 109 - 120
(Article)
Abstract
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 ... read more
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Keywords: cardiovascular disease (CVD), core outcome set, end-stage renal disease (ESRD), heart failure (HF), Hemodialysis (HD), myocardial infarction (MI), outcomes, outcomes research, patient-centered outcome (PRO), sudden cardiac death (SCD), trial design, Education/methods, Humans, Renal Dialysis/methods, Societies, Medical/standards, Consensus, Patient Participation/methods, Health Personnel/standards, Internationality, Outcome Assessment, Health Care/methods, Cardiovascular Diseases/diagnosis, Clinical Trials as Topic/methods, Nephrology, Research Support, Non-U.S. Gov't, Journal Article
DOI: https://doi.org/10.1053/j.ajkd.2020.01.022
ISSN: 0272-6386
Publisher: W.B. Saunders
Note: Funding Information: Executive Committee: Jonathan C. Craig, Allison Tong, Braden Manns, Roberto Pecoits-Filho, Tess Harris, David C. Wheeler, Wolfgang Winkelmayer. CVD Working Group: Adeera Levin, Emma O'Lone, William G. Herrington, Chuck A. Herzog, Michael V. Rocco, Giovanni Strippoli, Meg Jardine. Investigators: Myra Kleinpeter, Angela Ju, Yeoungjee Cho, Talia Gutman, Amelie Bernier-Jean, Laura James, Lorraine Hamiwka, Andrea K. Viecelli, 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. Emma O'Lone, MBChB, Andrea K. Viecelli, MD, Jonathan C. Craig, PhD, Allison Tong, PhD, Benedicte Sautenet, PhD, William G. Herrington, MD, Charles A. Herzog, MD, Tazeen H. Jafar, MD, MPH, Meg Jardine, PhD, Vera Krane, MD, Adeera Levin, MD, Jolanta Malyszko, PhD, Michael V. Rocco, MD, MSCE, Giovanni Strippoli, PhD, Marcello Tonelli, MD, Angela Yee Moon Wang, MD, PhD, Christoph Wanner, MD, Faiez Zannad, PhD, Wolfgang C. Winkelmayer, PhD, and David C. Wheeler, MD. This work was supported by the National Health and Medical Research Council (NHMRC; 1098815). Dr O'Lone receives support from the NHMRC Medical Postgraduate Scholarship (1114189). Dr Tong is supported by an NHMRC Fellowship (1106716). Dr Viecelli receives grant support from the NHMRC Medical Postgraduate Scholarship (1114539) and the Royal Australasian College of Physicians (Jacquot NHMRC Award for Excellence). The funders did not have a role in in defining the content of this report. Dr Herrington is supported by a Medical Research Council and Kidney Research UK Professor David Kerr Clinician Scientist Award and has received grants from the British Heart Foundation and Boehringer Ingelheim. Dr Jardine is supported by a Medical Research Future Fund Next Generation Clinical Researchers Program Career Development Fellowship; is responsible for research projects that have received unrestricted funding from Gambro, Baxter, CSL, Amgen, Eli Lilly, and Merck; has served on advisory boards sponsored by Akebia, Baxter, Boehringer Ingelheim, and Vifor; and has spoken at scientific meetings sponsored by Janssen, Amgen and Roche, with any consultancy, honoraria, or travel support paid to her institution. The other authors declare that they have no relevant financial interests. Received August 5, 2019. Evaluated by 2 external peer reviewers, with direct editorial input from an Associate Editor and a Deputy Editor. Accepted in revised form January 17, 2020. Funding Information: This work was supported by the National Health and Medical Research Council (NHMRC; 1098815 ). Dr O'Lone receives support from the NHMRC Medical Postgraduate Scholarship ( 1114189 ). Dr Tong is supported by an NHMRC Fellowship ( 1106716 ). Dr Viecelli receives grant support from the NHMRC Medical Postgraduate Scholarship ( 1114539 ) and the Royal Australasian College of Physicians (Jacquot NHMRC Award for Excellence). The funders did not have a role in in defining the content of this report. Publisher Copyright: © 2020 National Kidney Foundation, Inc.
(Peer reviewed)