Scientific Publications Database

Article Title: Scope and Consistency of Outcomes Reported in Randomized Trials Conducted in Adults Receiving Hemodialysis: A Systematic Review
Authors: Sautenet, Benedicte; Tong, Allison; Williams, Gabrielle; Hemmelgarn, Brenda R.; Manns, Braden; Wheeler, David C.; Tugwell, Peter; van Biesen, Wim; Winkelmayer, Wolfgang C.; Crowe, Sally; Harris, Tess; Evangelidis, Nicole; Hawley, Carmel M.; Pollock, Carol; Johnson, David W.; Polkinghorne, Kevan R.; Howard, Kirsten; Gallagher, Martin P.; Kerr, Peter G.; McDonald, Stephen P.; Ju, Angela; Craig, Jonathan C.
Journal: AMERICAN JOURNAL OF KIDNEY DISEASES Volume 72 Issue 1
Date of Publication:2018
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.