Fuller Candace C, Hua Wei, Leonard Charles E, Mosholder Andrew, Carnahan Ryan, Dutcher Sarah, King Katelyn, Petrone Andrew B, Rosofsky Robert, Shockro Laura A, Young Jessica, Min Jea Young, Binswanger Ingrid, Boudreau Denise, Griffin Marie R, Adgent Margaret A, Kuntz Jennifer, McMahill-Walraven Cheryl, Pawloski Pamala A, Ball Robert, Toh Sengwee
Department of Population Medicine, Harvard Pilgrim Health Care Institute, Harvard Medical School, Boston, MA, United States.
Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, United States.
JMIR Res Protoc. 2020 Nov 2;9(11):e21811. doi: 10.2196/21811.
Certain medications may increase the risk of death or death from specific causes (eg, sudden cardiac death), but these risks may not be identified in premarket randomized trials. Having the capacity to examine death in postmarket safety surveillance activities is important to the US Food and Drug Administration's (FDA) mission to protect public health. Distributed networks of electronic health plan databases used by the FDA to conduct multicenter research or medical product safety surveillance studies often do not systematically include death or cause-of-death information.
This study aims to develop reusable, generalizable methods for linking multiple health plan databases with the Centers for Disease Control and Prevention's National Death Index Plus (NDI+) data.
We will develop efficient administrative workflows to facilitate multicenter institutional review board (IRB) review and approval within a distributed network of 6 health plans. The study will create a distributed NDI+ linkage process that avoids sharing of identifiable patient information between health plans or with a central coordinating center. We will develop standardized criteria for selecting and retaining NDI+ matches and methods for harmonizing linked information across multiple health plans. We will test our processes within a use case comprising users and nonusers of antiarrhythmic medications.
We will use the linked health plan and NDI+ data sets to estimate the incidences and incidence rates of mortality and specific causes of death within the study use case and compare the results with reported estimates. These comparisons provide an opportunity to assess the performance of the developed NDI+ linkage approach and lessons for future studies requiring NDI+ linkage in distributed database settings. This study is approved by the IRB at Harvard Pilgrim Health Care in Boston, MA. Results will be presented to the FDA at academic conferences and published in peer-reviewed journals.
This study will develop and test a reusable distributed NDI+ linkage approach with the goal of providing tested NDI+ linkage methods for use in future studies within distributed data networks. Having standardized and reusable methods for systematically obtaining death and cause-of-death information from NDI+ would enhance the FDA's ability to assess mortality-related safety questions in the postmarket, real-world setting.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/21811.
某些药物可能会增加死亡风险或特定原因导致的死亡风险（如心源性猝死），但这些风险可能在上市前的随机试验中未被发现。具备在上市后安全监测活动中审查死亡情况的能力，对于美国食品药品监督管理局（FDA）保护公众健康的使命至关重要。FDA用于开展多中心研究或医疗产品安全监测研究的电子健康计划数据库分布式网络，通常未系统地纳入死亡或死因信息。
本研究旨在开发可重复使用、通用的方法，将多个健康计划数据库与疾病控制与预防中心的国家死亡索引升级版（NDI+）数据相链接。
我们将开发高效的管理工作流程，以促进在由6个健康计划组成的分布式网络内进行多中心机构审查委员会（IRB）的审查和批准。该研究将创建一个分布式NDI+链接流程，避免在健康计划之间或与中央协调中心共享可识别的患者信息。我们将制定选择和保留NDI+匹配项的标准化标准，以及在多个健康计划中协调链接信息的方法。我们将在一个包括抗心律失常药物使用者和非使用者的用例中测试我们的流程。
我们将使用链接的健康计划和NDI+数据集，估计研究用例中的死亡率和特定死因的发病率及发病率，并将结果与报告的估计值进行比较。这些比较提供了一个机会，以评估所开发的NDI+链接方法的性能，以及为未来在分布式数据库环境中需要NDI+链接的研究提供经验教训。本研究已获得马萨诸塞州波士顿哈佛朝圣者医疗保健公司的IRB批准。结果将在学术会议上提交给FDA，并发表在同行评审期刊上。
本研究将开发并测试一种可重复使用的分布式NDI+链接方法，目标是提供经过测试的NDI+链接方法，供未来在分布式数据网络中进行研究时使用。拥有从NDI+系统获取死亡和死因信息的标准化、可重复使用的方法，将增强FDA在上市后现实环境中评估与死亡率相关的安全问题的能力。
国际注册报告标识符（IRRID）：DERR1-10.2196/21811。
