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深度学习方法解析 OMOP 通用数据模型下膳食补充剂临床试验的纳入标准。

Deep Learning Approach to Parse Eligibility Criteria in Dietary Supplements Clinical Trials Following OMOP Common Data Model.

机构信息

Institute for Health Informatics.

University of Texas Health Science Center, Houston, TX, USA.

出版信息

AMIA Annu Symp Proc. 2021 Jan 25;2020:243-252. eCollection 2020.

PMID:33936396
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8075443/
Abstract

Dietary supplements (DSs) have been widely used in the U.S. and evaluated in clinical trials as potential interventions for various diseases. However, many clinical trials face challenges in recruiting enough eligible patients in a timely fashion, causing delays or even early termination. Using electronic health records to find eligible patients who meet clinical trial eligibility criteria has been shown as a promising way to assess recruitment feasibility and accelerate the recruitment process. In this study, we analyzed the eligibility criteria of 100 randomly selected DS clinical trials and identified both computable and non-computable criteria. We mapped annotated entities to OMOP Common Data Model (CDM) with novel entities (e.g., DS). We also evaluated a deep learning model (Bi-LSTM-CRF) for extracting these entities on CLAMP platform, with an average F1 measure of 0.601. This study shows the feasibility of automatic parsing of the eligibility criteria following OMOP CDM for future cohort identification.

摘要

膳食补充剂(DSs)在美国被广泛应用,并在临床试验中作为治疗各种疾病的潜在干预措施进行评估。然而,许多临床试验在及时招募足够合格患者方面面临挑战,导致延迟甚至提前终止。使用电子健康记录来寻找符合临床试验资格标准的合格患者已被证明是评估招募可行性和加速招募过程的一种有前途的方法。在这项研究中,我们分析了 100 项随机选择的 DS 临床试验的资格标准,并确定了可计算和不可计算的标准。我们将注释实体映射到 OMOP 通用数据模型 (CDM),其中包括新实体(例如 DS)。我们还在 CLAMP 平台上评估了一种用于提取这些实体的深度学习模型(Bi-LSTM-CRF),平均 F1 度量值为 0.601。这项研究表明,按照 OMOP CDM 自动解析资格标准用于未来队列识别是可行的。

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本文引用的文献

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Clinical Trial Generalizability Assessment in the Big Data Era: A Review.大数据时代临床试验的可推广性评估:综述。
Clin Transl Sci. 2020 Jul;13(4):675-684. doi: 10.1111/cts.12764. Epub 2020 Apr 10.
2
Comparing the Study Populations in Dietary Supplement and Drug Clinical Trials for Metabolic Syndrome and Related Disorders.比较膳食补充剂与药物治疗代谢综合征及相关疾病临床试验中的研究人群。
AMIA Jt Summits Transl Sci Proc. 2019 May 6;2019:799-808. eCollection 2019.
3
Criteria2Query: a natural language interface to clinical databases for cohort definition.Criteria2Query:一种用于定义队列的临床数据库自然语言接口。
J Am Med Inform Assoc. 2019 Apr 1;26(4):294-305. doi: 10.1093/jamia/ocy178.
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Automatic extraction of quantitative data from ClinicalTrials.gov to conduct meta-analyses.从 ClinicalTrials.gov 自动提取定量数据进行荟萃分析。
J Clin Epidemiol. 2019 Jan;105:92-100. doi: 10.1016/j.jclinepi.2018.08.023. Epub 2018 Sep 23.
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Classifying Clinical Trial Eligibility Criteria to Facilitate Phased Cohort Identification Using Clinical Data Repositories.对临床试验资格标准进行分类,以利用临床数据存储库促进分阶段队列识别。
AMIA Annu Symp Proc. 2018 Apr 16;2017:1754-1763. eCollection 2017.
6
Clinical trials recruitment planning: A proposed framework from the Clinical Trials Transformation Initiative.临床试验招募规划:来自临床试验转型倡议的一个拟议框架
Contemp Clin Trials. 2018 Mar;66:74-79. doi: 10.1016/j.cct.2018.01.003. Epub 2018 Jan 9.
7
An OMOP CDM-Based Relational Database of Clinical Research Eligibility Criteria.基于观察性医疗结果合作组织通用数据模型的临床研究资格标准关系数据库。
Stud Health Technol Inform. 2017;245:950-954.
8
Analysis of Temporal Constraints in Qualitative Eligibility Criteria of Cancer Clinical Studies.癌症临床研究定性纳入标准中的时间限制分析。
Proceedings (IEEE Int Conf Bioinformatics Biomed). 2016 Dec;2016:717-722. doi: 10.1109/BIBM.2016.7822607. Epub 2017 Jan 19.
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CLAMP - a toolkit for efficiently building customized clinical natural language processing pipelines.CLAMP - 一个用于高效构建定制化临床自然语言处理管道的工具包。
J Am Med Inform Assoc. 2018 Mar 1;25(3):331-336. doi: 10.1093/jamia/ocx132.
10
Dietary Supplement Use Was Very High among Older Adults in the United States in 2011-2014.2011年至2014年期间,美国老年人的膳食补充剂使用率非常高。
J Nutr. 2017 Oct;147(10):1968-1976. doi: 10.3945/jn.117.255984. Epub 2017 Aug 30.