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 Nephrology, Princess Alexandra Hospital, Brisbane, Queensland, Australia; School of Medicine, University of Queensland, Brisbane, Queensland, Australia.
J Am Coll Cardiol. 2018 Jun 19;71(24):2802-2810. doi: 10.1016/j.jacc.2018.04.012.
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.
长期接受血液透析的患者患心血管疾病的风险非常高，但通常被排除在针对普通人群或高危人群进行的临床试验之外。针对血液透析人群进行的试验没有普遍达成一致的心血管结局。在这篇综述中，我们强调报告血液透析患者心血管结局的试验通常持续时间较短（中位数为 3 至 6 个月）且规模较小（59%的试验<100 名参与者）。总体而言，心血管结局非常多样化，可能无法反映出对支持决策制定的患者和临床医生有意义的结果，因为它们通常是不确定临床重要性的替代指标。不同试验中使用的复合结局很少具有相同的组成部分。在一个单一试验通常不足以充分评估干预措施的临床和经济影响的领域中，试验之间的结果报告差异使得荟萃分析和解释所有可用证据的任务具有挑战性。目前正在医疗保健的许多专业领域中建立核心结局集，以避免这些问题。通过全球肾脏病标准化结局倡议，心血管疾病被确定为血液透析所有试验中需要报告的一个至关重要的核心领域。根据心血管结局报告的现状，目前正在与患者、护理人员和卫生专业人员合作，建立心血管疾病的核心结局测量。一致报告对血液透析患者和临床医生至关重要的心血管结局，将加强证据基础，为这一高风险人群提供信息。
