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Classification of Clinical Research Study Eligibility Criteria to Support Multi-Stage Cohort Identification Using Clinical Data Repositories

机译:临床研究的分类研究资格标准支持使用临床数据储存库的多阶段队列识别

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One of the challenges to using electronic health record (EHR) repositories for research is the difficulty mapping study subject eligibility criteria to the query capabilities of the repository. We sought to characterize criteria as "easy" (searchable in a typical repository), "hard" (requiring manual review of the record data), and "impossible" (not typically available in EHR repositories). We obtained 292 criteria from 20 studies available from Clinical Trials.gov and rated them according to our three types, plus a fourth "mixed" type. We had good agreement among three independent reviewers and chose 274 criteria that were characterized by single types for further analysis. The resulting analysis showed typical features of criteria that do and don't map to repositories. We propose that these features be used to guide researchers in specifying eligibility criteria to improve development of enrollment workflow, including the definition of EHR repository queries for self-service or analyst-mediated retrievals.
机译:使用电子健康记录(EHR)存储库的挑战之一是难以将研究主题资格标准映射到存储库的查询能力。我们寻求将标准描述为“轻松”(在典型的存储库中搜索),“硬”(需要手动查看记录数据),“不可能”(通常在EHR存储库中不可用)。我们获得了从临床试验中可获得的20项研究的292个标准.Gov并根据我们的三种类型评定它们,以及第四种“混合”类型。我们在三名独立审稿人之间进行了良好的一致性,并选择了274个标准,其特征是单一类型的进一步分析。由此产生的分析显示了标准的典型特征,并不映射到存储库。我们建议使用这些功能来指导研究人员指定改善入学工作流程的开发的资格标准,包括ehr存储库查询的自我服务或分析介导的检索的定义。

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