02783nas a2200373 4500000000100000008004100001100002100042700001700063700001600080700001800096700001900114700001700133700002500150700002300175700002100198700002000219700001600239700002300255700001400278700001900292700001700311700001500328700002100343700001800364700002300382700001600405700001700421700001900438245006100457300001400518490000700532520185600539022001402395 2018 d1 aTonelli Marcello1 aLevin Adeera1 aJardine Meg1 aWheeler David1 aCraig Jonathan1 aTong Allison1 aWinkelmayer Wolfgang1 aHerrington William1 aWanner Christoph1 aViecelli Andrea1 aO'Lone Emma1 aSautenet Benedicte1 aRoy David1 aHerzog Charles1 aJafar Tazeen1 aKrane Vera1 aMalyszko Jolanta1 aRocco Michael1 aStrippoli Giovanni1 aWang Angela1 aZannad Faiez1 aWebster Angela00aCardiovascular Outcomes Reported in Hemodialysis Trials. a2802-28100 v713 a

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.

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