Renal Unit, Sunshine Coast University Hospital, Birtinya, Australia.
Faculty of Medicine, The University of Queensland, Herston, Australia.
Cochrane Database Syst Rev. 2024 Apr 8;4(4):CD009535. doi: 10.1002/14651858.CD009535.pub3.
BACKGROUND: Home haemodialysis (HHD) may be associated with important clinical, social or economic benefits. However, few randomised controlled trials (RCTs) have evaluated HHD versus in-centre HD (ICHD). The relative benefits and harms of these two HD modalities are uncertain. This is an update of a review first published in 2014. This update includes non-randomised studies of interventions (NRSIs). OBJECTIVES: To evaluate the benefits and harms of HHD versus ICHD in adults with kidney failure. SEARCH METHODS: We contacted the Information Specialist and searched the Cochrane Kidney and Transplant Register of Studies up to 9 October 2022 using search terms relevant to this review. Studies in the Register are identified through searches of CENTRAL, MEDLINE, and EMBASE, conference proceedings, the International Clinical Trials Registry Platform (ICTRP) Search Portal, and ClinicalTrials.gov. We searched MEDLINE (OVID) and EMBASE (OVID) for NRSIs. SELECTION CRITERIA: RCTs and NRSIs evaluating HHD (including community houses and self-care) compared to ICHD in adults with kidney failure were eligible. The outcomes of interest were cardiovascular death, all-cause death, non-fatal myocardial infarction, non-fatal stroke, all-cause hospitalisation, vascular access interventions, central venous catheter insertion/exchange, vascular access infection, parathyroidectomy, wait-listing for a kidney transplant, receipt of a kidney transplant, quality of life (QoL), symptoms related to dialysis therapy, fatigue, recovery time, cost-effectiveness, blood pressure, and left ventricular mass. DATA COLLECTION AND ANALYSIS: Two authors independently assessed if the studies were eligible and then extracted data. The risk of bias was assessed, and relevant outcomes were extracted. Summary estimates of effect were obtained using a random-effects model, and results were expressed as risk ratios (RR) and their 95% confidence intervals (CI) for dichotomous outcomes and mean difference (MD) or standardised mean difference (SMD) and 95% CI for continuous outcomes. Confidence in the evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. Meta-analysis was performed on outcomes where there was sufficient data. MAIN RESULTS: From the 1305 records identified, a single cross-over RCT and 39 NRSIs proved eligible for inclusion. These studies were of varying design (prospective cohort, retrospective cohort, cross-sectional) and involved a widely variable number of participants (small single-centre studies to international registry analyses). Studies also varied in the treatment prescription and delivery (e.g. treatment duration, frequency, dialysis machine parameters) and participant characteristics (e.g. time on dialysis). Studies often did not describe these parameters in detail. Although the risk of bias, as assessed by the Newcastle-Ottawa Scale, was generally low for most studies, within the constraints of observational study design, studies were at risk of selection bias and residual confounding. Many study outcomes were reported in ways that did not allow direct comparison or meta-analysis. It is uncertain whether HHD, compared to ICHD, may be associated with a decrease in cardiovascular death (RR 0.92, 95% CI 0.80 to 1.07; 2 NRSIs, 30,900 participants; very low certainty evidence) or all-cause death (RR 0.80, 95% CI 0.67 to 0.95; 9 NRSIs, 58,984 patients; very low certainty evidence). It is also uncertain whether HHD may be associated with a decrease in hospitalisation rate (MD -0.50 admissions per patient-year, 95% CI -0.98 to -0.02; 2 NRSIs, 834 participants; very low certainty evidence), compared with ICHD. Compared with ICHD, it is uncertain whether HHD may be associated with receipt of kidney transplantation (RR 1.28, 95% CI 1.01 to 1.63; 6 NRSIs, 10,910 participants; very low certainty evidence) and a shorter recovery time post-dialysis (MD -2.0 hours, 95% CI -2.73 to -1.28; 2 NRSIs, 348 participants; very low certainty evidence). It remains uncertain if HHD may be associated with decreased systolic blood pressure (SBP) (MD -11.71 mm Hg, 95% CI -21.11 to -2.46; 4 NRSIs, 491 participants; very low certainty evidence) and decreased left ventricular mass index (LVMI) (MD -17.74 g/m, 95% CI -29.60 to -5.89; 2 NRSIs, 130 participants; low certainty evidence). There was insufficient data to evaluate the relative association of HHD and ICHD with fatigue or vascular access outcomes. Patient-reported outcome measures were reported using 18 different measures across 11 studies (QoL: 6 measures; mental health: 3 measures; symptoms: 1 measure; impact and view of health: 6 measures; functional ability: 2 measures). Few studies reported the same measures, which limited the ability to perform meta-analysis or compare outcomes. It is uncertain whether HHD is more cost-effective than ICHD, both in the first (SMD -1.25, 95% CI -2.13 to -0.37; 4 NRSIs, 13,809 participants; very low certainty evidence) and second year of dialysis (SMD -1.47, 95% CI -2.72 to -0.21; 4 NRSIs, 13,809 participants; very low certainty evidence). AUTHORS' CONCLUSIONS: Based on low to very low certainty evidence, HHD, compared with ICHD, has uncertain associations or may be associated with decreased cardiovascular and all-cause death, hospitalisation rate, slower post-dialysis recovery time, and decreased SBP and LVMI. HHD has uncertain cost-effectiveness compared with ICHD in the first and second years of treatment. The majority of studies included in this review were observational and subject to potential selection bias and confounding, especially as patients treated with HHD tended to be younger with fewer comorbidities. Variation from study to study in the choice of outcomes and the way in which they were reported limited the ability to perform meta-analyses. Future research should align outcome measures and metrics with other research in the field in order to allow comparison between studies, establish outcome effects with greater certainty, and avoid research waste.
背景:家庭血液透析(HHD)可能与重要的临床、社会或经济效益相关。然而,很少有随机对照试验(RCT)评估 HHD 与中心血液透析(ICHD)。这两种血液透析方式的相对益处和危害尚不确定。这是 2014 年首次发表的一篇综述的更新。本次更新纳入了干预措施的非随机对照研究(NRSIs)。
目的:评估肾衰竭成人接受 HHD 与 ICHD 的益处和危害。
检索方法:我们联系了信息专家并对 Cochrane 肾脏病和移植组登记册进行了检索,检索时间截至 2022 年 10 月 9 日,使用了与本综述相关的检索词。登记册中的研究通过检索 CENTRAL、MEDLINE 和 EMBASE、会议论文集、国际临床试验注册平台(ICTRP)检索门户和 ClinicalTrials.gov 确定。我们对 MEDLINE(OVID)和 EMBASE(OVID)进行了 NRSIs 的检索。
选择标准:纳入评估 HHD(包括社区住房和自我护理)与肾衰竭成人接受 ICHD 的 RCTs 和 NRSIs。感兴趣的结局为心血管死亡、全因死亡、非致死性心肌梗死、非致死性卒、全因住院、血管通路干预、中心静脉导管插入/更换、血管通路感染、甲状旁腺切除术、等待肾移植、接受肾移植、生活质量(QoL)、与透析治疗相关的症状、疲劳、恢复时间、成本效益、血压和左心室质量。
数据收集和分析:两位作者独立评估研究是否符合纳入标准,然后提取数据。评估了偏倚风险,并提取了相关结局。使用随机效应模型获得效应量的汇总估计值,并使用风险比(RR)及其 95%置信区间(CI)表示二分类结局,使用均数差(MD)或标准化均数差(SMD)及其 95%CI 表示连续性结局。使用 Grading of Recommendations Assessment, Development and Evaluation(GRADE)方法评估证据的可信度。如果有足够的数据,则进行荟萃分析。
主要结果:从 1305 条记录中,仅有一项单交叉 RCT 和 39 项 NRSIs 被证明符合纳入标准。这些研究设计各异(前瞻性队列研究、回顾性队列研究、横断面研究),纳入的参与者数量也各不相同(小型单中心研究到国际登记分析)。研究还在治疗方案和实施(例如治疗持续时间、频率、透析机参数)和参与者特征(例如透析时间)方面存在差异。研究往往没有详细描述这些参数。尽管大多数研究的纽卡斯尔-渥太华量表评估的偏倚风险较低,但在观察性研究设计的限制下,研究仍存在选择偏倚和残余混杂的风险。许多研究结果的报告方式不允许直接比较或荟萃分析。尚不确定 HHD 是否可能与心血管死亡(RR 0.92,95%CI 0.80 至 1.07;2 项 NRSIs,30900 名参与者;极低确定性证据)或全因死亡(RR 0.80,95%CI 0.67 至 0.95;9 项 NRSIs,58984 名患者;极低确定性证据)减少相关。也不确定 HHD 是否可能与住院率降低相关(MD-0.50 人/年,95%CI-0.98 至-0.02;2 项 NRSIs,834 名参与者;极低确定性证据)。与 ICHD 相比,HHD 可能与接受肾移植(RR 1.28,95%CI 1.01 至 1.63;6 项 NRSIs,10910 名参与者;极低确定性证据)和透析后恢复时间缩短(MD-2.0 小时,95%CI-2.73 至-1.28;2 项 NRSIs,348 名参与者;极低确定性证据)相关。尚不确定 HHD 是否可能与收缩压(SBP)降低相关(MD-11.71mmHg,95%CI-21.11 至-2.46;4 项 NRSIs,491 名参与者;极低确定性证据)和左心室质量指数(LVMI)降低相关(MD-17.74g/m,95%CI-29.60 至-5.89;2 项 NRSIs,130 名参与者;低确定性证据)。没有足够的数据来评估 HHD 和 ICHD 与疲劳或血管通路结局的相对关联。患者报告的结局指标使用了 11 项研究中的 18 种不同措施(生活质量:6 种措施;心理健康:3 种措施;症状:1 种措施;对健康的影响和看法:6 种措施;功能能力:2 种措施)。很少有研究报告相同的措施,这限制了进行荟萃分析或比较结局的能力。尚不确定 HHD 是否比 ICHD 在第一年(SMD-1.25,95%CI-2.13 至-0.37;4 项 NRSIs,13809 名参与者;极低确定性证据)和第二年(SMD-1.47,95%CI-2.72 至-0.21;4 项 NRSIs,13809 名参与者;极低确定性证据)更具成本效益。
作者结论:基于低到极低确定性证据,与 ICHD 相比,HHD 可能与心血管和全因死亡减少、住院率降低、透析后恢复时间较慢、收缩压和 LVMI 降低相关。在治疗的第一年和第二年,与 ICHD 相比,HHD 的成本效益可能不确定。本综述中纳入的大多数研究都是观察性研究,存在选择偏倚和混杂的风险,特别是接受 HHD 治疗的患者往往年龄较小,合并症较少。由于研究之间在治疗选择和实施方面存在差异,以及在报告结局方面的差异,限制了进行荟萃分析的能力。未来的研究应使结局指标和衡量标准与该领域的其他研究保持一致,以便在研究之间进行比较,确定结局影响的确定性,并避免研究浪费。
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