A novel semantic representation for eligibility criteria in clinical trials
A novel semantic representation for eligibility criteria in clinical trials
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DOI：
10.1016/j.jbi.2017.03.013
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发表时间：
2017-05-01
影响因子：
4.5
通讯作者：
Tsuji, Masatsugu
中科院分区：
文献类型：
--
作者：
Chondrogiannis, Efthymios;Andronikou, Vassiliki;Tsuji, Masatsugu
资格标准(EC)是临床研究的重要组成部分，是临床研究成本、持续时间和总体成功的决定因素。它们的正式、计算机可处理的描述可以通过启用它们的智能处理、可复制性和与其他数据的链接来显著改进临床试验设计和进行。为了代表EC的目的，调查了相关标准以及已发表的文献。此外，与临床专家合作分析了相当多的临床试验.gov研究，以确定和分类临床研究的重要参数。这一过程的结果是EC表示法；一个符合CDISC的标准组织模式，以及一个以患者为中心的正式表达模式，与国际分类和编码适当地联系在一起。它对随机选择的200个EC的评估表明，它可以充分地达到其目的，同时它也可以与为EC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。(C)2017 Elsevier Inc.保留所有权利。
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. (C) 2017 Elsevier Inc. All rights reserved.