Feasibility of Embedding a Scalable, Virtually Enabled Biorepository in the Electronic Health Record for Precision Medicine.
Feasibility of Embedding a Scalable, Virtually Enabled Biorepository in the Electronic Health Record for Precision Medicine.
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DOI：
10.1001/jamanetworkopen.2020.37739
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发表时间：
2021-02-01
影响因子：
13.8
通讯作者：
Seymour CW
中科院分区：
文献类型：
--
作者：
DeMerle KM;Kennedy JN;Peck Palmer OM;Brant E;Chang CH;Dickson RP;Huang DT;Angus DC;Seymour CW
使用大规模、廉价的电子健康记录嵌入式基础设施来捕获高比例的合格参与者并创建虚拟启用的临床和生物存储库是否可行？在这项针对1027例脓毒症患者的队列研究中，开发了一种新的基础设施，称为虚拟启用的生物储存库和嵌入式电子健康记录，可扩展的精准医疗队列（VESPRE）。与传统的研究设计相比，VESPRE似乎证明了可行的数字筛选，成功的招募，生物采样和更低的成本。这项研究的结果表明，VESPRE是嵌入在EHR中的基础设施，它创建了一个虚拟的生物储存库，可以在患者，中心和实验室之间以较低的增量成本和负担进行扩展。精准医疗的基石是识别和使用生物标志物，帮助患者进行针对性治疗。这种方法需要开发和随后询问与注释良好的临床数据相关的大规模生物库。创建这些数据关联生物库的传统方法成本高且耗时长，特别是在需要时间敏感的临床数据和生物标本的急性条件下。开发一个虚拟启用的生物储存库和电子健康记录（EHR）嵌入式，可扩展的精准医疗队列（VESPRE），并比较VESPRE与急性护理传统研究设计的可行性，招募和成本。在一项前瞻性队列研究中，为3428例患者生成了EHR嵌入式筛查警报，2199例患者（64%）符合条件并接受了筛查。其中，1027例患者（30%）入组。VESPRE是在一个前瞻性队列中开发的，该队列包括1027例脓毒症患者（年龄≥18岁），在急诊科就诊后6小时内发生3例脓毒症，用于监管合规性、可行性、内部有效性和成本。VESPRE基础设施包括（1）自动化EHR筛查，（2）残余血液收集以创建虚拟启用的生物储存库，以及（3）自动化临床数据提取。该研究于2017年10月17日至2019年6月6日在宾夕法尼亚州西南部的一家学术机构进行。监管合规性、入组、自动筛选的内部有效性、生物储存库的获取和成本。在入组研究的1027例患者中，549例被纳入概念验证分析（305例[56%]男性）;中位（SD）年龄为59（17）岁。VESPRE收集了12963份残留血液和尿液样本，并证明了临床、生物标志物和微生物组分析的充分可行性。在20个月的测试中，现有运营基础设施之外的总成本为39 417.50美元（项目管理14 880.00美元，实验室用品/人员22 717.50美元，数据管理1820.00美元）-每例入组患者约为39美元，而传统队列研究为每例患者239美元。这项研究的结果表明，在一个使用通用EHR平台和集中式实验室系统收集数据的大型美国卫生系统中，可以使用VESPRE，这是一种用于精准医学的大规模，廉价的EHR嵌入式基础设施。在脓毒症背景下进行测试，VESPRE似乎以较低的增量成本捕获了高比例的合格患者。这项队列研究检查了一种虚拟启用的生物储存库和电子健康记录（EHR）嵌入式工具，用于败血症患者的精准医疗。
Is use of a large-scale, inexpensive electronic health record–embedded infrastructure that captures a high proportion of eligible participants and creates a virtually enabled clinical and biologic repository feasible? In this cohort study of 1027 patients with sepsis, a novel infrastructure, termed virtually enabled biorepository and electronic health record–embedded, scalable cohort for precision medicine (VESPRE) was developed. VESPRE appeared to demonstrate feasible digital screening, successful enrollment, biologic sampling, and lower costs compared with a traditional study design. Results of this study suggest that VESPRE, an infrastructure embedded in the EHR that creates a virtually enabled biorepository, may be scalable across patients, centers, and laboratories at low incremental cost and burden. A cornerstone of precision medicine is the identification and use of biomarkers that help subtype patients for targeted treatment. Such an approach requires the development and subsequent interrogation of large-scale biobanks linked to well-annotated clinical data. Traditional means of creating these data-linked biobanks are costly and lengthy, especially in acute conditions that require time-sensitive clinical data and biospecimens. To develop a virtually enabled biorepository and electronic health record (EHR)–embedded, scalable cohort for precision medicine (VESPRE) and compare the feasibility, enrollment, and costs of VESPRE with those of a traditional study design in acute care. In a prospective cohort study, the EHR-embedded screening alert was generated for 3428 patients, and 2199 patients (64%) were eligible and screened. Of these, 1027 patients (30%) were enrolled. VESPRE was developed for regulatory compliance, feasibility, internal validity, and cost in a prospective cohort of 1027 patients (aged ≥18 years) with sepsis-3 within 6 hours of presentation to the emergency department. The VESPRE infrastructure included (1) automated EHR screening, (2) remnant blood collection for creation of a virtually enabled biorepository, and (3) automated clinical data abstraction. The study was conducted at an academic institution in southwestern Pennsylvania from October 17, 2017, to June 6, 2019. Regulatory compliance, enrollment, internal validity of automated screening, biorepository acquisition, and costs. Of the 1027 patients enrolled in the study, 549 were included in the proof-of-concept analysis (305 [56%] men); median (SD) age was 59 (17) years. VESPRE collected 12 963 remnant blood and urine samples and demonstrated adequate feasibility for clinical, biomarker, and microbiome analyses. Over the 20-month test, the total cost beyond the existing operations infrastructure was $39 417.50 ($14 880.00 project management, $22 717.50 laboratory supplies/staff, and $1820.00 data management)—approximately $39 per enrolled patient vs $239 per patient for a traditional cohort study. Results of this study suggest that, in a large US health system that collects data using a common EHR platform and centralized laboratory system, VESPRE, a large-scale, inexpensive EHR-embedded infrastructure for precision medicine can be used. Tested in the sepsis setting, VESPRE appeared to capture a high proportion of eligible patients at low incremental cost. This cohort study examines a virtually enabled biorepository and electronic health record (EHR)–embedded tool for use in precision medicine in patients with sepsis.
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影响因子：
15.1
作者：
Rhee, Chanu;Kadri, Sameer S.;Klompas, Michael
通讯作者：
Klompas, Michael
影响因子：
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作者：
Rhee, Chanu;Jones, Travis M.;Klompas, Michael
通讯作者：
Klompas, Michael
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Rhodes, Andrew;Evans, Laura E.;Dellinger, R. Phillip
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Dellinger, R. Phillip
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作者：
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通讯作者：
Orme, James F., Jr.
影响因子：
76.2
作者：
Scicluna, Brendon P.;van Vught, Lonneke A.;van der Poll, Tom
通讯作者：
van der Poll, Tom