Multi-institutional distributed data networks for real-world evidence about medical devices: building unique device identifiers into longitudinal data (BUILD).
Multi-institutional distributed data networks for real-world evidence about medical devices: building unique device identifiers into longitudinal data (BUILD).
复制标题
用于医疗设备真实世界证据的多机构分布式数据网络：将唯一设备标识符构建为纵向数据（BUILD）。
DOI：
10.1093/jamiaopen/ooac035
复制
发表时间：
2022-07
期刊：
影响因子：
2.1
通讯作者：
Simard, Edgar P.
中科院分区：
文献类型：
--
作者：
Drozda, Joseph P., Jr.;Graham, Jove;Muhlestein, Joseph B.;Tcheng, James E.;Roach, James;Forsyth, Tom;Knight, Stacey;McKinnon, Andrew;May, Heidi;Wilson, Natalia A.;Berlin, Jesse A.;Simard, Edgar P.
关键词：
支持使用来自电子健康记录(EHR)和其他来源的真实世界数据(RWD)、使用唯一设备识别符(UDI)链接到设备信息来开发强大的上市后设备评估系统。为了在3个机构中创建一致的与设备相关的EHR RWD，我们建立了分布式数据网络，并使用由24个表和472个字段组成的通用数据模型创建了UDI丰富的研究数据库(UDIR)。为了测试该系统，2010至2019年间接受冠状动脉支架治疗的患者被加载到每个机构的UDIR中，以支持分布式查询，而不共享可识别的患者信息。通过3次质量保证检查测试了系统执行查询的能力。为了证明数据的表面有效性，采用分布分析对2012至2017年间接受Zotarolimus或everolimus支架治疗的患者进行了回顾性生存研究。采用倾向性评分匹配的方法比较移植后12个月内发生6种心血管事件的风险。测试询问已建立的网络功能。在分析中，我们确定了9,141名患者(Mercy = 4905，Geisinger = 4109，InterMountain = 127)；平均年龄65 ± 12岁，男性69%，Zotarimus 23%。3个机构的单独配对分析显示，随后的经皮冠状动脉介入治疗(P = .14-.52)、死亡(P = .16-.78)和复合终点(P = .16-.62)的危险比估计值(Zotarolimus和everolimus)分别为0.85-1.59、1.06-2.03和0.94-1.40。分析结果与比较这些设备的临床研究一致。该项目表明，多机构数据网络可以通过分布式分析提供临床相关的真实世界证据，同时保持数据隐私。
To support development of a robust postmarket device evaluation system using real-world data (RWD) from electronic health records (EHRs) and other sources, employing unique device identifiers (UDIs) to link to device information. To create consistent device-related EHR RWD across 3 institutions, we established a distributed data network and created UDI-enriched research databases (UDIRs) employing a common data model comprised of 24 tables and 472 fields. To test the system, patients receiving coronary stents between 2010 and 2019 were loaded into each institution’s UDIR to support distributed queries without sharing identifiable patient information. The ability of the system to execute queries was tested with 3 quality assurance checks. To demonstrate face validity of the data, a retrospective survival study of patients receiving zotarolimus or everolimus stents from 2012 to 2017 was performed using distributed analysis. Propensity score matching was used to compare risk of 6 cardiovascular outcomes within 12 months postimplantation. The test queries established network functionality. In the analysis, we identified 9141 patients (Mercy = 4905, Geisinger = 4109, Intermountain = 127); mean age 65 ± 12 years, 69% males, 23% zotarolimus. Separate matched analyses at the 3 institutions showed hazard ratio estimates (zotarolimus vs everolimus) of 0.85–1.59 for subsequent percutaneous coronary intervention (P = .14–.52), 1.06–2.03 for death (P = .16–.78) and 0.94–1.40 for the composite endpoint (P = .16–.62). The analysis results are consistent with clinical studies comparing these devices. This project shows that multi-institutional data networks can provide clinically relevant real-world evidence via distributed analysis while maintaining data privacy.
登录
查看更多内容
影响因子：
4.8
作者：
Tcheng, James E.;Crowley, Jay;Drozda, Joseph P., Jr.
通讯作者：
Drozda, Joseph P., Jr.
影响因子：
11.3
作者：
Chen, Kang-Yin;Rha, Seung-Woon;Park, Seung Jung
通讯作者：
Park, Seung Jung
DOI：
10.1016/j.hjdsi.2015.07.002
发表时间：
2016-06-01
影响因子：
2.5
作者：
Drozda, Joseph P., Jr.;Dudley, Curtis;Hutchison, Lisa
通讯作者：
Hutchison, Lisa
影响因子：
3.5
作者：
Steele, Garen D.;Fehring, Thomas K.;Nadaud, Matthew C.
通讯作者：
Nadaud, Matthew C.
DOI：
10.1136/bmjsit-2019-000024
发表时间：
2020
期刊：
BMJ surgery, interventions, & health technologies
影响因子：
--
作者：
Drozda J;Zeringue A;Dummitt B;Yount B;Resnic F
通讯作者：
Resnic F