利用电子健康记录加强潜在药物安全信号证据的创新方法。

IF 3.5 3区 医学 Q1 HEALTH CARE SCIENCES & SERVICES Journal of Medical Systems Pub Date : 2024-05-16 DOI:10.1007/s10916-024-02070-2
H Abedian Kalkhoran, J Zwaveling, F van Hunsel, A Kant
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引用次数: 0

摘要

来自自发报告系统(SRS)的报告可产生假设。需要更多的证据,如更多的报告,才能确定所产生的药物-事件关联实际上是否是安全信号。然而,药物不良反应(ADRs)报告不足会延误信号检测。通过使用自然语言处理技术,不同来源的真实世界数据可用于主动收集潜在安全信号的额外证据。本研究旨在探索使用电子健康记录(EHR)根据自发 ADR 报告中的初步迹象识别更多病例的可行性,目的是加强潜在安全信号的证据基础。针对荷兰药物警戒中心 Lareb 的 SRS 生成的两个确诊信号和两个潜在信号,使用基于文本挖掘的工具 CTcue 在莱顿大学医疗中心的电子病历中进行了有针对性的搜索。通过在电子病历的结构化字段和自由文本字段中构建和运行查询来搜索其他病例。我们为已确认的信号确定了至少五个额外病例,并为每个潜在安全信号确定了一个额外病例。大部分已确认信号的病例在荷兰药品评估委员会检测到信号之前就已记录在电子病历中。已确定的潜在信号病例已报告给 Lareb,作为信号检测的进一步证据。我们的研究结果突显了根据基本假设在电子病历中进行有针对性的搜索,为信号生成提供进一步证据的可行性。
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An innovative method to strengthen evidence for potential drug safety signals using Electronic Health Records.

Reports from spontaneous reporting systems (SRS) are hypothesis generating. Additional evidence such as more reports is required to determine whether the generated drug-event associations are in fact safety signals. However, underreporting of adverse drug reactions (ADRs) delays signal detection. Through the use of natural language processing, different sources of real-world data can be used to proactively collect additional evidence for potential safety signals. This study aims to explore the feasibility of using Electronic Health Records (EHRs) to identify additional cases based on initial indications from spontaneous ADR reports, with the goal of strengthening the evidence base for potential safety signals. For two confirmed and two potential signals generated by the SRS of the Netherlands Pharmacovigilance Centre Lareb, targeted searches in the EHR of the Leiden University Medical Centre were performed using a text-mining based tool, CTcue. The search for additional cases was done by constructing and running queries in the structured and free-text fields of the EHRs. We identified at least five additional cases for the confirmed signals and one additional case for each potential safety signal. The majority of the identified cases for the confirmed signals were documented in the EHRs before signal detection by the Dutch Medicines Evaluation Board. The identified cases for the potential signals were reported to Lareb as further evidence for signal detection. Our findings highlight the feasibility of performing targeted searches in the EHR based on an underlying hypothesis to provide further evidence for signal generation.

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来源期刊
Journal of Medical Systems
Journal of Medical Systems 医学-卫生保健
CiteScore
11.60
自引率
1.90%
发文量
83
审稿时长
4.8 months
期刊介绍: Journal of Medical Systems provides a forum for the presentation and discussion of the increasingly extensive applications of new systems techniques and methods in hospital clinic and physician''s office administration; pathology radiology and pharmaceutical delivery systems; medical records storage and retrieval; and ancillary patient-support systems. The journal publishes informative articles essays and studies across the entire scale of medical systems from large hospital programs to novel small-scale medical services. Education is an integral part of this amalgamation of sciences and selected articles are published in this area. Since existing medical systems are constantly being modified to fit particular circumstances and to solve specific problems the journal includes a special section devoted to status reports on current installations.
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