Practical use of a multicenter clinical research support system connected to electronic medical records
Practical use of a multicenter clinical research support system connected to electronic medical records
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DOI：
10.1016/j.cmpb.2021.106362
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发表时间：
2021-08
影响因子：
6.1
通讯作者：
S. Manabe;Toshihiro Takeda;Atsushi Hattori;Masashi Yamamoto;Yoshie Shimai;Yoshiki Namiuchi;Junji Yamaguchi;Tomomi Yamada;Shozo Konishi;Y. Matsumura
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文献类型：
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作者：
S. Manabe;Toshihiro Takeda;Atsushi Hattori;Masashi Yamamoto;Yoshie Shimai;Yoshiki Namiuchi;Junji Yamaguchi;Tomomi Yamada;Shozo Konishi;Y. Matsumura
背景电子医疗记录（EMR）被广泛使用，但在许多情况下，它们在物理上与因特网分离的网络内使用。多中心临床研究使用互联网连接的电子数据采集（EDC）系统收集数据，其中录入EMR的数据被手动转录到EDC系统中。此外，用于临床研究的医学图像也是人工采集的。在EMR和不同的数据结构供应商之间的变化妨碍了使用的数据为clinical research.MethodsWe解决了这个问题，通过开发一个网络基础设施，大坂大学医院和附属医院在大坂地区的临床研究，并引入了临床数据收集系统（CDCS）。在各医院的EMR网络中，我们实现了CRF报告器，该报告器使用模板积累临床研究数据，然后将数据发送到大坂大学医院数据中心的管理服务器。为了组织存储在每个EMR中的患者概况数据和临床实验室数据以用于临床研究，根据我们的通用数据输出接口规范，通过每个供应商开发的接口模块从模板中检索数据。录入临床研究CRF报告模板的数据也记录在EMR进度记录中，并发送至数据管理服务器。该网络基础设施还可以用作医疗图像收集系统，该系统自动从每个医院的PACS收集用于研究的图像。这些系统的管理下发出的CDCS.ResultsA网络基础设施之间建立了19家医院共同的主题编号，和CRF记者被纳入EMR。在13家医院采用了医学图像传输系统。自2013年以来，该系统已用于28项临床研究，截至2020年12月31日，已收集9，987例病例数据。结论使用医学图像传输系统将CRF报告器添加到EMR中，有助于收集研究数据。
BackgroundElectronic medical records (EMRs) are widely used, but in many cases, they are used within a network physically separated from the Internet. Multicenter clinical studies use Internet-connected electronic data capture (EDC) systems to collect data, where data entered into the EMR are manually transcribed into the EDC system. In addition, medical images for clinical research are also collected manually. Variations in EMRs and differing data structures among vendors hamper the use of data for clinical research.MethodsWe solved this problem by developing a network infrastructure for clinical research between Osaka University Hospital and affiliated hospitals in the Osaka area and introducing a clinical data collection system (CDCS). In each hospital's EMR network, we implemented a CRF reporter that accumulated data for clinical research using a template and then sent the data to a management server in the Osaka University Hospital Data Center. To organize the patient profile data and clinical laboratory data stored in each EMR for use in clinical research, the data are retrieved from the template by an interface module developed by each vendor, according to our common data output interface specification. The data entered into the CRF reporter template for clinical research are also recorded in the EMR progress notes and sent to the data management server. This network infrastructure can also be used as a medical image collection system that automatically collects images for research from PACS at each hospital. These systems are managed under common subject numbers issued by the CDCS.ResultsA network infrastructure was established among 19 hospitals, and a CRF reporter was incorporated into the EMR. A medical image transfer system was introduced in 13 hospitals. Since 2013, 28 clinical studies have been conducted using this system, and data for 9,987 cases have been collected as of December 31, 2020.ConclusionIncorporating a CRF reporter with medical image transfer system into the EMR has proven useful for collecting research data.