Chondrogiannis Efthymios, Andronikou Vassiliki, Tagaris Anastasios, Karanastasis Efstathios, Varvarigou Theodora, Tsuji Masatsugu
National Technical University of Athens, 9 Heroon Politechniou Str, 15773 Athens, Greece.
University of Hyogo, 7-1-28, Minatojima-Minami-cho, Chuo-ku, Kobe, Hyogo 650-0047, Japan.
J Biomed Inform. 2017 May;69:10-23. doi: 10.1016/j.jbi.2017.03.013. Epub 2017 Mar 21.
Eligibility Criteria (EC) comprise an important part of a clinical study, being determinant of its cost, duration and overall success. Their formal, computer-processable description can significantly improve clinical trial design and conduction by enabling their intelligent processing, replicability and linkability with other data. For EC representation purposes, related standards were investigated, along with published literature. Moreover, a considerable number of clinicaltrials.gov studies was analyzed in collaboration with clinical experts for the determination and classification of parameters of clinical research importance. The outcome of this process was the EC Representation; a CDISC-compliant schema for organizing criteria along with a patient-centric model for their formal expression, properly linked with international classifications and codifications. Its evaluation against 200 randomly selected EC indicated that it can adequately serve its purpose, while it can be also combined with existing tools and components developed for both EC specification and especially application to Electronic Health Records.
入选标准（EC）是临床研究的重要组成部分，决定着研究的成本、持续时间和总体成功率。其正式的、可由计算机处理的描述能够通过实现智能处理、可复制性以及与其他数据的可链接性，显著改善临床试验的设计与实施。为了进行入选标准的表示，我们研究了相关标准以及已发表的文献。此外，我们与临床专家合作，对大量clinicaltrials.gov上的研究进行了分析，以确定和分类具有临床研究重要性的参数。这一过程的成果是入选标准表示；一个符合CDISC的用于组织标准的模式，以及一个以患者为中心的用于其正式表达的模型，并与国际分类和编码正确链接。针对200个随机选择的入选标准对其进行的评估表明，它能够充分实现其目的，同时还可以与为入选标准规范特别是应用于电子健康记录而开发的现有工具和组件相结合。
