Use of Registries, Claims and Health System Data to Enhance the Evaluation of Cardiovascular Devices

使用注册、索赔和健康系统数据来加强心血管设备的评估

• 批准号: 10734959
• 负责人: Issa J. Dahabreh
• 金额: $ 77.69万
• 依托单位: BETH ISRAEL DEACONESS MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-05-01 至 2027-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10734959
• 关键词: Benchmarking; Boston; Cardiovascular Diseases; Cardiovascular system; Caring; Cerebrum; Clinical; Clinical Trials; Communities; Community Practice; Complement; Data; Data Analyses; Data Set; Device Approval; Device Safety; Devices; Dimensions; Effectiveness; Elderly; Electronic Health Record; Eligibility Determination; Ethics; Evaluation; Future; Goals; Health system; Healthcare Systems; Heart; Heart Valves; Institution; Link; Massachusetts; Medical; Medical Device; Methodology; Methods; Mitral Valve; Morbidity - disease rate; Observational Study; Outcome; Patient Care; Patient Representative; Patient-Centered Care; Patients; Physicians; Population; Provider; Public Health; Quasi-experiment; Registries; Research; Research Design; Risk; Safety; Sample Size; Science; Selection Bias; Stents; Target Populations; Time; United States; Variant; Woman; Work; abdominal aorta; analytical method; black patient; cardiovascular risk factor; clinical care; clinical practice; clinically relevant; data registry; data resource; design; follow-up; health goals; high risk; improved; innovation; instrument; mechanical circulatory support; mortality; neighborhood disadvantage; novel; patient population; patient subsets; post-market; programs; provider adoption; randomized trial; repaired; response; social disparities; tool; treatment effect; trial design

PROJECT SUMMARY/ABSTRACT There is an urgent need to develop and implement more efficient approaches to evaluate cardiovascular devices in representative patient populations. Data from registries, health care systems, and payers, often include detailed clinical baseline information and longitudinal outcomes on a large number of patients representative of those cared for in clinical practice. However, the most commonly performed non- randomized evaluations using these data have high risk of bias due to a number of methodological challenges, including unmeasured differences between patients receiving different treatments (confounding) and misalignment of treatment eligibility, treatment initiation and beginning of follow up (selection bias). Thus, there is great enthusiasm for exploiting newer study design and analysis strategies that can more closely approximate the results of a desired but yet-to-be-performed randomized trial, while gaining the efficiency and representativeness of using data routinely collected in the course of patient care. Applying state-of-the-science methods to diverse and rich datasets may identify specific populations with different responses to device treatment - a key step in the ability to deliver individualized patient-centered care. In this renewal application, we will continue to pursue the overarching goal of developing innovative approaches to enhance the efficiency, fidelity and generalizability of cardiovascular device evaluation through the analysis of unique multidimensional linked datasets. In Aim 1, we will apply new methods to transport inferences about treatment effects from pivotal randomized trials of high-risk cardiovascular devices to new target populations representative of patients seen in contemporary practice. In Aim 2, we will evaluate the safety and effectiveness of high-risk cardiovascular devices through application of the target trial framework, a set of conceptual and practical tools for designing observational emulations of randomized trials that is well suited to overcome common forms of selection bias (e.g., immortal time bias) in cardiovascular device comparisons. In Aim 3, we will apply quasi-experimental methods to evaluate the safety and effectiveness of these devices, including instrumental variable and instrumented difference-in-difference designs. In each of the three aims, we will develop and apply methods to examine subgroups of patients under-represented in trials, specifically women, Black patients, and patients from socially disadvantaged communities. This research will inform the safety and effectiveness of several cardiovascular devices that have not been well studied, provide important clinical information to practicing physicians in the community, and create new standards for the future regulatory evaluation of medical devices using transportability, observational, and quasi-experimental approaches to complement standard randomized trials.

项目摘要/摘要 迫切需要开发和实施更有效的方法来评估 代表性患者人群中的心血管设备。来自注册表，医疗保健系统的数据， 和付款人，通常包括大量详细的临床基线信息和纵向结果 代表在临床实践中受到照顾的患者。但是，最常见的非 - 使用这些数据的随机评估由于许多方法上的挑战而具有偏见的高风险， 包括接受不同治疗（混杂）和 治疗资格的错位，治疗起始和随访的开始（选择偏差）。因此，那里 非常热情利用新的研究设计和分析策略，这些策略可以更紧密地 在获得效率和 在患者护理过程中通常收集的数据的代表性。应用最先进的科学 多种数据集和丰富数据集的方法可以识别具有不同响应设备的特定人群 治疗 - 提供个性化以患者为中心的护理的能力的关键步骤。在此续签应用中， 我们将继续追求开发创新方法以增强的总体目标 通过分析，心血管装置评估的效率，保真度和概括性 唯一的多维链接数据集。在AIM 1中，我们将采用新方法来运输有关的推论 高危心血管设备的关键随机试验到新目标人群的治疗效果 当代实践中看到的患者的代表。在AIM 2中，我们将评估安全性和 通过应用目标试验框架，高风险心血管设备的有效性，一组 设计随机试验的观察性仿真的概念和实用工具，非常适合 在心血管装置比较中克服常见的选择偏见（例如不朽的时间偏见）。在 AIM 3，我们将采用准实验方法来评估这些设备的安全性和有效性， 包括仪器变量和仪器差异差异设计。在三个目标中的每个目标中，我们 将开发和应用方法来检查试验中代表性不足的患者的亚组，特别是 妇女，黑人患者和来自社会不利社区的患者。这项研究将告知 几种尚未进行精心研究的心血管设备的安全性和有效性，提供重要的 向社区中的医生提供临床信息，并为未来创建新的标准 使用可运输性，观察性和准实验的医疗设备进行监管评估 补充标准随机试验的方法。

项目成果

Comparing Baseline Data From Registries With Trials: Evidence From the CathPCI Registry and DAPT Study.

• DOI: 10.1016/j.jcin.2021.03.065
• 发表时间: 2021-06-28
• 期刊: JACC. Cardiovascular interventions
• 作者: Butala NM;Faridi KF;Secemsky EA;Song Y;Curtis J;Gibson CM;Brindis R;Shen C;Yeh RW
• 通讯作者: Yeh RW

SCOT-HEART: Does it live up to the PROMISE?

SCOT-HEART：它兑现了承诺吗？

• DOI: 10.1016/j.jcct.2019.01.008
• 发表时间: 2019
• 期刊: Journal of cardiovascular computed tomography
• 影响因子: 5.4
• 作者: Strom,JordanB;Shen,Changyu;Yeh,RobertW
• 通讯作者: Yeh,RobertW

Comparability of Event Adjudication Versus Administrative Billing Claims for Outcome Ascertainment in the DAPT Study: Findings From the EXTEND-DAPT Study.

• DOI: 10.1161/circoutcomes.120.006589
• 发表时间: 2021-01
• 期刊: Circulation. Cardiovascular quality and outcomes
• 作者: Faridi KF;Tamez H;Butala NM;Song Y;Shen C;Secemsky EA;Mauri L;Curtis JP;Strom JB;Yeh RW
• 通讯作者: Yeh RW

Geographic Patterns of Growth for Transcatheter Aortic Valve Replacement in the United States.

美国经导管主动脉瓣置换术增长的地理模式。

• DOI: 10.1161/circulationaha.119.040788
• 发表时间: 2019
• 期刊: Circulation
• 影响因子: 37.8
• 作者: Kundi,Harun;Faridi,KamilF;Wang,Yun;Wadhera,RishiK;Valsdottir,LindaR;Popma,JeffreyJ;Kramer,DanielB;Yeh,RobertW
• 通讯作者: Yeh,RobertW

Rural-Urban Disparities In All-Cause Mortality Among Low-Income Medicare Beneficiaries, 2004-17.

• DOI: 10.1377/hlthaff.2020.00420
• 发表时间: 2021-03
• 期刊: Health affairs (Project Hope)
• 作者: Loccoh E;Joynt Maddox KE;Xu J;Shen C;Figueroa JF;Kazi DS;Yeh RW;Wadhera RK
• 通讯作者: Wadhera RK