Development and evaluation of a clinical trial simulation system by the second use of EMRs

我建立了一个数据仓库的标准模型，其中包括一个搜索系统和从EMR中检索的数据元素，其目的是预测临床试验中的患者数量。然后我建立了一个方法，即，如何将临床试验的入选/排除标准转化为系统项目中的项目，使用EMR检索系统检索符合临床试验入选/排除标准的患者。我评价了检索系统提供的估计患者数量与累积实现之间的相关性，并评价了将试验合格性标准中的临床表现映射到EMR中的结构化数据元素的完整性。此外，作为电子病历的第二次使用，我进行了药物流行病学研究和使用电子病历模板作为病例报告表收集数据的试点研究。

I established the standard model of a data warehouse with a search system and data elements to retrieve from EMRs, which aims to predict the number of patients in a clinical trial. Then I established a method, i.e., how to translate the inclusion/exclusion criteria of a clinical trial into items in the items of the system, to search a patient in line with the inclusion/exclusion criteria of a clinical trial using EMRs search system. I evaluated the correlation between the estimated number of patients provided by the search system and the accrual achievement, and evaluated the completeness of mapping clinical manifestation in trial eligibility criteria into structured data elements in the EMRs. Moreover, As the second use of EMRs, I carried out a pharmacoepidemiology study and pilot-study of a use of EMR templates as case report forms to collect the data.