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）：在美国开始维持透析的末期肾脏疾病患者的平均寿命约为三年。大多数临床试验测试了各种潜在的有希望的干预措施，无法证明透析患者死亡风险的降低。继续寻求改善预后，导致了常规血液透析处方的改变，以显着增加每次课程的治疗时间或治疗频率。在最近结束的经常出现的血液透析网络（FHN）每日试验中，死亡风险或左心室质量增加的共同组合的好处为这些修改的处方提供了支持。但是，在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）以较低的频率（每周三次）传递。同样，最受欢迎的每日血液透析形式是在家中使用用户友好的设备进行的，但与FHN日常试验中使用的系统相比，具有较低的溶质清除率（短期，低流量，家庭血液透析，SD-LF-HHD）。 NICHD或SD-LF-HHD患者无法在任何公开可用的数据源中识别，包括美国肾脏数据系统（USRDS），但此信息可以在透析提供商的数据中很容易获得。在这个项目中，我们将从达维塔（Davita）获取，完善和墨水数据，该组织将在43个州中对待美国透析患者的几乎三分之一，其中USRD会检查NICHD和SD-LF-HHD患者的结果（分别为n = 2400和3500）。这些疗法与腹膜透析和/或每周三次的常规血液透析的比较将足以用于全因死亡率，这是主要结果度量。新颖的分析策略将使用边际结构模型，非参数因果模型，并通过（1）基线患者特征，（2）时间变化的模态变化以及（3）审查移植或辍学的混淆。将检查护理现场（具有/没有NICHD计划的设施中的TWICHD结果）的混淆，并应与选择自我保健家庭透析SD-LF-HHD结果的患者的难以估量的偏见相比，将与PD进行比较，这是另一种家庭透析治疗。链接数据的高粒度将使我们能够研究 NICHD和SD-LF-HHD具有其他结果，包括特定原因死亡率，住院，溶质清除，高血压，贫血，矿物质代谢，营养，透析耐受性和血管通道发病率。 DAVITA-USRDS数据链接将提供对Medicare索赔数据的访问权限，该数据将用于计算NICHD和SD-LF-HHD的增量社会成本效益或成本节省。因此，这项为期3年的建议将有效地产生有关两种日益流行的透析疗法的时间敏感信息，这些信息将是立即临床和

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？