Comparative Effectiveness of Dialysis Modalities

透析方式的比较有效性

基本信息

批准号：
8713986
负责人：
Kamyar Kalantar-Zadeh
金额：
$ 33.87万
依托单位：
UNIVERSITY OF WASHINGTON
依托单位国家：
美国
项目类别：
财政年份：
2012
资助国家：
美国
起止时间：
2012-09-15 至 2016-07-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8713986
关键词：
Accounting Anemia Blood Pressure Blood Vessels Caring Cessation of life Characteristics Clinical Clinical Trials Cost Savings Country Data Data Linkages Data Sources Decision Making Devices Dialysis patients Dialysis procedure Drops End stage renal failure Ethnic group Frequencies Future Goals Grant Healthcare Systems Hemodialysis Heterogeneity Home Hemodialysis Home environment Hospitalization Hospitals Hypertension Individual Information Systems Ink Intervention Kidney Laboratories Lead Left Ventricular Mass Life Expectancy Link Maintenance Measures Medicare claim Metabolism Methods Minerals Modality Modeling Modification Morbidity - disease rate Outcome Outcome Measure Patients Pattern Peritoneal Dialysis Physicians Provider Risk Self Care Site Structural Models System Testing Time Transplantation United States Weight censorship clinical practice clinically relevant comparative effectiveness control trial cost cost effectiveness effectiveness research follow-up improved mortality novel nutrition primary outcome programs public health relevance racial and ethnic secondary outcome solute user-friendly

项目摘要

DESCRIPTION (provided by applicant): The average life-expectancy of end-stage renal disease patients starting maintenance dialysis in the US is about three years. Most clinical trials that tested a variety of potentially promising interventions have been unable to demonstrate a reduction in death risk of dialysis patients. The continued quest to improve outcomes has led to modifications of the conventional hemodialysis prescription to either significantly increase treatment time for each session or the frequency of therapy. The benefits on the co-primary composite of death risk or left ventricular mass increase seen in the recently concluded Frequent Hemodialysis Network (FHN) Daily Trial lends support to these modified prescriptions. However, the therapies being increasingly used in clinical practice differ from the interventions tested in the FHN trial. Nocturnal in-center hemodialysis (NICHD) provides longer treatment times but is generally delivered at a lower frequency (thrice weekly) than nocturnal home hemodialysis (5-6 times/ week) studied by FHN. Similarly, the most popular form of daily hemodialysis is performed at home with a device that is user-friendly but delivers lower solute clearances (short-daily, low-flow, home hemodialysis, SD-LF-HHD) than systems used in the FHN Daily Trial. NICHD or SD-LF-HHD patients cannot be identified in any publicly available data-source, including from the United States Renal Data System (USRDS) but this information is readily available in data from dialysis providers. In this project, we will obtain, refine, and ink data from DaVita, an organization that treats almost one-third of all US dialysis patients across 43 states, with the USRDS to examine outcomes of NICHD and SD-LF-HHD patients (n=2400, and 3500 respectively). The comparisons of these therapies with peritoneal dialysis and/or thrice-weekly conventional hemodialysis will be adequately powered for all-cause mortality, the primary outcome measure. The novel analytic strategy will use marginal structural models, a non-parametric causal model and will adjust for confounding from (1) baseline patient characteristics, (2) time-varying modality change, and (3) censoring for transplantation or drop-out. Confounding from site of care (TWICHD outcomes in facilities with/without NICHD programs) will be examined and to account for difficult-to-measure bias from patients who choose self-care home dialysis SD-LF-HHD outcomes will compared to PD, another home dialysis therapy. The high granularity of the linked data will allow us to study the association of NICHD and SD-LF-HHD with additional outcomes including cause-specific mortality, hospitalizations, solute clearances, hypertension, anemia, mineral metabolism, nutrition, dialysis tolerability, and vascular access morbidity. The DaVita-USRDS data linkage will provide access to Medicare claims data which will be used to calculate incremental societal cost-effectiveness or cost-savings with NICHD and SD-LF-HHD. Thus, this 3-year proposal will efficiently generate a wealth of time-sensitive information about two increasingly popular dialysis therapies that will be of immediate clinical and

描述（由申请人提供）：在美国开始维持性透析的终末期肾病患者的平均预期寿命约为三年。大多数临床试验测试了各种可能有希望的干预措施，但未能证明可以降低透析患者的死亡风险。对改善结果的不断追求导致了对传统血液透析处方的修改，以显着增加每次治疗的时间或治疗频率。最近结束的频繁血液透析网络 (FHN) 每日试验中看到的对死亡风险或左心室质量增加的共同主要综合指标的益处为这些修改后的处方提供了支持。然而，临床实践中越来越多地使用的疗法与 FHN 试验中测试的干预措施不同。夜间中心血液透析 (NICHD) 提供更长的治疗时间，但通常比 FHN 研究的夜间家庭血液透析（每周 5-6 次）频率较低（每周三次）。同样，最流行的日常血液透析形式是在家中使用用户友好的设备进行，但与 FHN 中使用的系统相比，其溶质清除率较低（每日短时间、低流量、家庭血液透析，SD-LF-HHD）每日试用。 NICHD 或 SD-LF-HHD 患者无法在任何公开可用的数据源中识别，包括来自美国肾脏数据系统 (USRDS) 的数据，但可以在透析提供商的数据中轻松获得此信息。在这个项目中，我们将从 DaVita 获取、完善和记录数据，该组织治疗了 43 个州几乎三分之一的美国透析患者，并与 USRDS 一起检查 NICHD 和 SD-LF-HHD 患者的结果（n分别 =2400 和 3500）。这些疗法与腹膜透析和/或每周三次的传统血液透析的比较将足以衡量全因死亡率（主要结果指标）。新的分析策略将使用边际结构模型（一种非参数因果模型），并将针对以下因素进行调整：（1）基线患者特征，（2）随时间变化的模式变化，以及（3）移植或退出的审查。将检查护理地点的混杂因素（有/无 NICHD 计划的设施中的 TWICHD 结果），并考虑到选择自我护理家庭透析的患者难以测量的偏差，SD-LF-HHD 结果将与 PD 进行比较，另一个家庭透析治疗。链接数据的高粒度将使我们能够研究 NICHD 和 SD-LF-HHD 具有额外的结局，包括特定原因死亡率、住院治疗、溶质清除率、高血压、贫血、矿物质代谢、营养、透析耐受性和血管通路发病率。 DaVita-USRDS 数据链接将提供对医疗保险索赔数据的访问，这些数据将用于计算 NICHD 和 SD-LF-HHD 的增量社会成本效益或成本节约。因此，这项为期 3 年的提案将有效地产生大量关于两种日益流行的透析疗法的时间敏感信息，这些信息将立即应用于临床和治疗。

项目成果

期刊论文数量（15）

专著数量（0）

科研奖励数量（0）

会议论文数量（0）

专利数量（0）

American Society of Nephrology quiz and questionnaire 2012: renal replacement therapy.

2012 年美国肾脏病学会测验和调查问卷：肾脏替代疗法。

DOI：
10.2215/cjn.00450113
发表时间：
2013
期刊：
Clinical journal of the American Society of Nephrology : CJASN
影响因子：
0
作者：
Mehrotra,Rajnish;Glassock,RichardJ;Bleyer,AnthonyJ
通讯作者：
Bleyer,AnthonyJ

Incremental and Once- to Twice-Weekly Hemodialysis: From Experience to Evidence.

DOI：
10.1016/j.ekir.2017.07.006
发表时间：
2017-09
期刊：
Kidney international reports
影响因子：
6
作者：
Obi Y;Kalantar-Zadeh K
通讯作者：
Kalantar-Zadeh K

Surviving the first year of peritoneal dialysis: enduring hard times.

熬过腹膜透析的第一年：忍受艰难时期。

DOI：
10.1053/j.ajkd.2014.08.002
发表时间：
2014
期刊：
American journal of kidney diseases : the official journal of the National Kidney Foundation
影响因子：
0
作者：
Chen,JolineLT;Mehrotra,Rajnish;Kalantar-Zadeh,Kamyar
通讯作者：
Kalantar-Zadeh,Kamyar

Translating an understanding of the determinants of technique failure to maximize patient time on peritoneal dialysis?

转化对技术失败决定因素的理解，以最大限度地延长患者的腹膜透析时间？