Comparative Effectiveness of Dialysis Modalities

透析方式的比较有效性

• 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
• 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

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(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 这测试了各种潜在的有希望的干预措施，但无法证明降低透析患者的死亡风险。对改善结果的持续追求导致了对传统血液透析处方的修改，以显著增加每次治疗的时间或治疗频率。在最近结束的频繁血液透析网络(FHN)每日试验中看到的死亡风险或左心室重量增加的共同初级组合的好处支持了这些修改后的处方。然而，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)提供的频率(每周三次)要低。同样，最流行的日常血液透析是在家中进行的，该设备用户友好，但提供比FHN Daily试验中使用的系统更低的溶质清除(短日、低流量、家庭血液透析、SD-LF-HHD)。NICHD或SD-LF-HHD患者不能在任何公开可用的数据来源中识别，包括来自美国肾脏数据系统(USRDS)的数据，但这些信息很容易从透析提供者的数据中获得。在这个项目中，我们将从DaVita获得、提炼和打印数据，DaVita是一个组织，治疗43个州近三分之一的美国透析患者，USRDS检查NICHD和SD-LF-HHD患者(分别为2400人和3500人)的结果。将这些疗法与腹膜透析和/或每周三次的常规血液透析进行比较，将足以降低全因死亡率，这是主要的结果衡量标准。新的分析策略将使用边缘结构模型，非参数因果模型，并将根据(1)基线患者特征，(2)随时间变化的模式变化，以及(3)对移植或退出的审查进行调整。来自护理现场的混淆(有/没有NICHD计划的设施中的TWICHD结果)将被检查，并考虑到选择自理家庭透析的患者的难以测量的偏差，SD-LF-HHD的结果将与另一种家庭透析疗法PD进行比较。关联数据的高粒度将使我们能够研究 NICHD和SD-LF-HHD，以及其他结果，包括特定原因的死亡率、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路发病率。DaVita-USRDS数据链接将提供对Medicare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关于两种日益流行的透析疗法的丰富的时间敏感信息，这两种疗法将立即用于临床和

项目成果

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
• 作者: Mehrotra,Rajnish;Glassock,RichardJ;Bleyer,AnthonyJ
• 通讯作者: Bleyer,AnthonyJ

Nutritional Issues in Peritoneal Dialysis Patients: How Do They Differ From That of Patients Undergoing Hemodialysis?

• DOI: 10.1053/j.jrn.2013.01.031
• 发表时间: 2013-05-01
• 期刊: JOURNAL OF RENAL NUTRITION
• 影响因子: 3.2
• 作者: Mehrotra, Rajnish

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？

• DOI: 10.3747/pdi.2012.00270
• 发表时间: 2013
• 期刊: Peritoneal dialysis international : journal of the International Society for Peritoneal Dialysis
• 作者: Mehrotra,Rajnish

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
• 作者: Chen,JolineLT;Mehrotra,Rajnish;Kalantar-Zadeh,Kamyar
• 通讯作者: Kalantar-Zadeh,Kamyar

Incremental dialysis for preserving residual kidney function-Does one size fit all when initiating dialysis?

• DOI: 10.1111/sdi.12701
• 发表时间: 2018-07
• 期刊: Seminars in dialysis
• 影响因子: 1.6
• 作者: Mathew AT;Obi Y;Rhee CM;Chou JA;Kalantar-Zadeh K
• 通讯作者: Kalantar-Zadeh K