Scope and Consistency of Outcomes Reported in Randomized Trials Conducted in Adults Receiving Hemodialysis: A Systematic Review

Bénédicte Sautenet; Allison Tong; Gabrielle Williams; Brenda R Hemmelgarn; Braden Manns; David C Wheeler; Peter Tugwell; Wim van Biesen; Wolfgang C Winkelmayer; Sally Crowe; Tess Harris; Nicole Evangelidis; Carmel M Hawley; Carol Pollock; David W Johnson; Kevan R Polkinghorne; Kirsten Howard; Martin P Gallagher; Peter G Kerr; Stephen P McDonald; Angela Ju; Jonathan C Craig

doi:10.1053/j.ajkd.2017.11.010

Scope and Consistency of Outcomes Reported in Randomized Trials Conducted in Adults Receiving Hemodialysis: A Systematic Review

Am J Kidney Dis. 2018 Jul;72(1):62-74. doi: 10.1053/j.ajkd.2017.11.010. Epub 2018 Feb 21.

Authors

Bénédicte Sautenet¹, Allison Tong², Gabrielle Williams², Brenda R Hemmelgarn³, Braden Manns³, David C Wheeler⁴, Peter Tugwell⁵, Wim van Biesen⁶, Wolfgang C Winkelmayer⁷, Sally Crowe⁸, Tess Harris⁹, Nicole Evangelidis², Carmel M Hawley¹⁰, Carol Pollock¹¹, David W Johnson¹⁰, Kevan R Polkinghorne¹², Kirsten Howard¹³, Martin P Gallagher¹⁴, Peter G Kerr¹², Stephen P McDonald¹⁵, Angela Ju², Jonathan C Craig²

Affiliations

¹ Sydney School of Public Health, The University of Sydney, Sydney, Australia; Centre for Kidney Research, The Children's Hospital at Westmead, Westmead, Sydney, Australia; University Francois Rabelais, Tours, France; Department of Nephrology and Clinical Immunology, Tours Hospital, Tours, France; INSERM, U1246, Tours, France. Electronic address: benedicte.sautenet@univ-tours.fr.
² Sydney School of Public Health, The University of Sydney, Sydney, Australia; Centre for Kidney Research, The Children's Hospital at Westmead, Westmead, Sydney, Australia.
³ Department of Medicine, University of Calgary, Calgary, Canada; Department of Community Health Sciences, University of Calgary, Calgary, Canada; Libin Cardiovascular Institute, University of Calgary, Calgary, Canada; O'Brien Institute of Public Health, University of Calgary, Calgary, Canada; University of Calgary, Calgary, Canada.
⁴ Centre for Nephrology, University College London, London, United Kingdom.
⁵ Department of Medicine, University of Ottawa, Ottawa, Canada.
⁶ Renal Division, Ghent University Hospital, Ghent, Belgium.
⁷ Selzman Institute for Kidney Health, Section of Nephrology, Baylor College of Medicine, Houston, TX.
⁸ Crowe Associates, Oxon, United Kingdom.
⁹ PKD International, Geneva, Switzerland.
¹⁰ Queensland School of Medicine, University of Queensland at Princess Alexandra Hospital, Brisbane, Australia; Translational Research Institute, Brisbane, Australia; Metro South and Ipswich Nephrology and Transplant Services (MINTS), Brisbane, Australia.
¹¹ Renal Division, Kolling Institute, Sydney, New South Wales, Australia.
¹² Monash Medical Centre and Monash University, Clayton, Australia; Department of Epidemiology & Preventative Medicine, Monash University, Clayton, Australia.
¹³ Sydney School of Public Health, The University of Sydney, Sydney, Australia.
¹⁴ Concord Clinical School, The University of Sydney, Sydney, Australia.
¹⁵ Northern Adelaide Renal and Transplantation Service, Royal Adelaide Hospital, Adelaide, Australia; Faculty of Health Science, University of Adelaide, Adelaide, Australia.

PMID: 29475768
DOI: 10.1053/j.ajkd.2017.11.010

Abstract

Background: Clinical trials are most informative for evidence-based decision making when they consistently measure and report outcomes of relevance to stakeholders. We aimed to assess the scope and consistency of outcomes reported in trials for hemodialysis.

Study design: Systematic review.

Setting & population: Adults requiring maintenance hemodialysis enrolled in clinical trials.

Selection criteria: All Cochrane systematic reviews of interventions published by August 29, 2016, and the trials published and registered in ClinicalTrials.gov since January 2011.

Interventions: Any hemodialysis-related interventions.

Outcomes: Frequency and characteristics of the reported outcome domains and measures.

Results: From the 362 trials, we extracted and classified 10,713 outcome measures (a median of 21 [IQR, 10-39] per trial) into 81 different outcome domains, of which 42 (52%) were surrogate; 25 (31%), clinical; and 14 (17%), patient reported. The number of outcome measures reported significantly changed over time. The 5 most commonly reported domains were all surrogates: phosphate (125 [35%] trials), dialysis adequacy (120 [33%]), anemia (115 [32%]), inflammatory markers (114 [31%]), and calcium (109 [30%]). Mortality, cardiovascular diseases, and quality of life were reported very infrequently (73 [20%], 44 [12%], and 32 [9%], respectively).

Limitations: For feasibility, we included a sampling frame that included only trials identified in Cochrane systematic reviews or ClinicalTrials.gov.

Conclusions: Outcomes reported in clinical trials involving adults receiving hemodialysis are focused on surrogate outcomes, rather than clinical and patient-centered outcomes. There is also extreme multiplicity and heterogeneity at every level: domain, measure, metric, and time point. Estimates of the comparative effectiveness of available interventions are unreliable and improvements over time have been inconsistent.

Keywords: Hemodialysis; core outcomes; nephrology; outcomes; patient-centered outcomes; study quality; surrogate outcome; systematic review.

Publication types

Research Support, Non-U.S. Gov't
Systematic Review

MeSH terms

Adult
Humans
Kidney Failure, Chronic / diagnosis
Kidney Failure, Chronic / epidemiology
Kidney Failure, Chronic / therapy*
Outcome Assessment, Health Care / methods
Outcome Assessment, Health Care / trends*
Randomized Controlled Trials as Topic / methods
Randomized Controlled Trials as Topic / standards*
Renal Dialysis / methods
Renal Dialysis / trends*