Drozda Joseph P, 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
Mercy, Chesterfield, Missouri, USA.
Center for Pharmacy Innovation and Outcomes, Geisinger, Danville, Pennsylvania, USA.
JAMIA Open. 2022 May 25;5(2):ooac035. doi: 10.1093/jamiaopen/ooac035. eCollection 2022 Jul.
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 ( = .14-.52), 1.06-2.03 for death ( = .16-.78) and 0.94-1.40 for the composite endpoint ( = .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.
利用来自电子健康记录（EHR）和其他来源的真实世界数据（RWD），支持开发一个强大的上市后设备评估系统，采用唯一设备标识符（UDI）来链接设备信息。
为了在3个机构中创建与设备相关的一致的EHR RWD，我们建立了一个分布式数据网络，并使用由24个表和472个字段组成的通用数据模型创建了富含UDI的研究数据库（UDIR）。为了测试该系统，将2010年至2019年间接受冠状动脉支架植入的患者加载到每个机构的UDIR中，以支持分布式查询，同时不共享可识别的患者信息。通过3次质量保证检查来测试系统执行查询的能力。为了证明数据的表面效度，使用分布式分析对2012年至2017年间接受佐他莫司或依维莫司支架植入的患者进行了回顾性生存研究。倾向得分匹配用于比较植入后12个月内6种心血管结局的风险。
测试查询建立了网络功能。在分析中，我们识别出9141名患者（Mercy机构 = 4905名，Geisinger机构 = 4109名，Intermountain机构 = 127名）；平均年龄65±12岁，69%为男性，23%使用佐他莫司。在3个机构分别进行匹配分析显示，对于后续经皮冠状动脉介入治疗，佐他莫司与依维莫司相比的风险比估计值为0.85 - 1.59（P = 0.14 - 0.52），对于死亡为1.06 - 2.03（P = 0.16 - 0.78），对于复合终点为0.94 - 1.40（P = 0.16 - 0.62）。
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。
