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J Am Coll Cardiol. 2018 Jun 19;71(24):2802-2810. doi: 10.1016/j.jacc.2018.04.012.

Cardiovascular Outcomes Reported in Hemodialysis Trials.

Author information

1
Sydney School of Public Health, The University of Sydney, Sydney, New South Wales, Australia; Centre for Kidney Research, The Children's Hospital at Westmead, Sydney, New South Wales, Australia. Electronic address: eolo0909@uni.sydney.edu.au.
2
Department of Nephrology, Princess Alexandra Hospital, Brisbane, Queensland, Australia; School of Medicine, University of Queensland, Brisbane, Queensland, Australia.
3
Sydney School of Public Health, The University of Sydney, Sydney, New South Wales, Australia; Centre for Kidney Research, The Children's Hospital at Westmead, Sydney, New South Wales, Australia; Childrens Hospital Westmead, Sydney, New South Wales, Australia.
4
Sydney School of Public Health, The University of Sydney, Sydney, New South Wales, Australia; Centre for Kidney Research, The Children's Hospital at Westmead, Sydney, New South Wales, Australia.
5
University Francois Rabelais, Tours, France; Department of Nephrology and Clinical Immunology, Tours Hospital, Tours, France; INSERM, U1153, Paris, France.
6
St. Vincent's Hospital, Sydney, New South Wales, Australia.
7
Medical Research Council Population Health Research Unit, Clinical Trial Service Unit and Epidemiological Studies Unit, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom.
8
Division of Cardiology, Department of Medicine, Hennepin County Medical Center/University of Minnesota, Minneapolis, Minnesota.
9
Program in Health Services & Systems Research, Duke-NUS Graduate Medical School, Singapore; Department of Community Health Science, Aga Khan University, Karachi, Pakistan; Section of Nephrology, Department of Medicine, Aga Khan University, Karachi, Pakistan.
10
The George Institute for Global Health, Sydney, New South Wales, Australia.
11
Division of Nephrology, Department of Internal Medicine and Comprehensive Heart Failure Centre, University Hospital of Würzburg, Würzburg, Germany.
12
Division of Nephrology, University of British Columbia, Vancouver, British Columbia, Canada; BC Provincial Renal Agency, Vancouver, British Columbia, Canada; Centre for Health Evaluation and Outcomes Research, St. Paul's Hospital, Vancouver, British Columbia, Canada.
13
Department of Nephrology, Dialysistherapy and Internal Medicine, Warsaw Medical University, Warsaw, Poland.
14
Section on Nephrology, Wake Forest School of Medicine, Winston-Salem, North Carolina.
15
Sydney School of Public Health, The University of Sydney, Sydney, New South Wales, Australia; Centre for Kidney Research, The Children's Hospital at Westmead, Sydney, New South Wales, Australia; Department of Emergency and Organ Transplantation, University of Bari, Bari, Italy; Medical Scientific Office, Diaverum, Lund, Sweden; Diaverum Academy, Bari, Italy.
16
Department of Medicine, Division of Nephrology, University of Calgary, Calgary, Alberta, Canada.
17
Department of Medicine, Queen Mary Hospital, University of Hong Kong, Hong Kong, China.
18
Renal Division, University Hospital of Würzburg, Würzburg, Germany.
19
Inserm Clinical Investigation Center 1403, Université de Lorraine, CHU de Nancy, Nancy, France; Institut Lorrain du Coeur et des Vaisseaux CHU and Université de Lorraine, Nancy, France.
20
Selzman Institute for Kidney Health, Section of Nephrology, Baylor College of Medicine, Houston, Texas.
21
University College London, London, United Kingdom.

Abstract

Patients on long-term hemodialysis are at very high risk for cardiovascular disease but are usually excluded from clinical trials conducted in the general population or in at-risk populations. There are no universally agreed cardiovascular outcomes for trials conducted specifically in the hemodialysis population. In this review, we highlight that trials reporting cardiovascular outcomes in hemodialysis patients are usually of short duration (median 3 to 6 months) and are small (59% of trials have <100 participants). Overall, the cardiovascular outcomes are very heterogeneous and may not reflect outcomes that are meaningful to patients and clinicians in supporting decision making, as they are often surrogates of uncertain clinical importance. Composite outcomes used in different trials rarely share the same components. In a field in which a single trial is often insufficiently powered to fully assess the clinical and economic impact of interventions, differences in outcome reporting across trials make the task of meta-analysis and interpretation of all the available evidence challenging. Core outcome sets are now being established across many specialties in health care to prevent these problems. Through the global Standardized Outcomes in Nephrology-Hemodialysis initiative, cardiovascular disease was identified as a critically important core domain to be reported in all trials in hemodialysis. Informed by the current state of reporting of cardiovascular outcomes, a core outcome measure for cardiovascular disease is currently being established with involvement of patients, caregivers, and health professionals. Consistent reporting of cardiovascular outcomes that are critically important to hemodialysis patients and clinicians will strengthen the evidence base to inform care in this very high-risk population.

KEYWORDS:

cardiovascular; composites; hemodialysis; outcomes

PMID:
29903353
DOI:
10.1016/j.jacc.2018.04.012

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