Expanding the OMOP Common Data Model to Support Perinatal Research in Network Studies.

IF 2.4 4区医学 Q3 PHARMACOLOGY & PHARMACY

Pharmacoepidemiology and Drug Safety Pub Date : 2025-02-01 DOI:10.1002/pds.70106

Alicia Abellan, Edward Burn, Nhung T H Trinh, Theresa Burkard, Alison Callahan, Sergio Fernández-Bertolín, Eimir Hurley, Clara Rodriguez, Elena Segundo, Daniel R Morales, Hedvig M E Nordeng, Talita Duarte-Salles

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引用次数: 0

Abstract

Objectives: The Observational Medical Outcomes Partnership common data model (OMOP-CDM) is a useful tool for large-scale network analysis but currently lacks a structured approach to pregnancy episodes. We aimed to develop and implement a perinatal expansion for the OMOP-CDM to facilitate perinatal network research.

Methods: We collaboratively developed a perinatal expansion with input from domain experts and stakeholders to reach consensus. The structure and vocabularies followed the OMOP-CDM ontological framework principles. We tested the expansion using SIDIAP and Norwegian databases. We developed a diagnostics package for quality control assessment and conducted a descriptive analysis on the captured perinatal data mapped to the OMOP-CDM.

Results: The perinatal expansion consists of a pregnancy table and an infant table, each with required and optional variables incorporated into standardized vocabularies. Quality assessment of the perinatal expansion table in SIDIAP and Norwegian databases demonstrated accurate capture of perinatal characteristics. Descriptive analysis measured the number of pregnancies (SIDIAP: 646 530; Norway: 746 671), pregnancy outcomes (e.g., 0.5% stillbirths in SIDIAP and 0.4% in Norway), gestational length (median [IQR] in days, SIDIAP: 273 [56-280]; Norway: 280 [273-286]), number of infants (Norway: 758 806), and birth weight (median [IQR] in grams, Norway: 3520 [3175-3860)], among other relevant variables.

Discussion and conclusion: We developed and implemented a perinatal expansion that captures important variables for perinatal research and allows interoperability with existing tables in the OMOP-CDM, which is expected to facilitate future network studies. The publicly available diagnostics package enables testing the implementation of the extension table and the quality and completeness of available data on pregnancy and pregnancy-related outcomes in databases mapped to the OMOP CDM.

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扩展OMOP公共数据模型以支持围产期网络研究。

目的：观察性医疗结果合作伙伴共同数据模型（OMOP-CDM）是大规模网络分析的有用工具，但目前缺乏结构化的妊娠发作方法。我们的目标是开发和实施OMOP-CDM的围产期扩展，以促进围产期网络研究。方法：我们与领域专家和利益相关者合作开发围产期扩展，以达成共识。结构和词汇表遵循OMOP-CDM本体框架原则。我们使用SIDIAP和挪威数据库测试了扩展。我们开发了一个用于质量控制评估的诊断包，并对捕获的映射到OMOP-CDM的围产期数据进行了描述性分析。结果：围产期扩展包括妊娠表和婴儿表，每个表都有必要和可选的变量纳入标准化词汇。SIDIAP和挪威数据库中围产期扩展表的质量评估显示围产期特征的准确捕获。描述性分析测量了怀孕人数(SIDIAP: 646 530；挪威：746 671)，妊娠结局（例如SIDIAP为0.5%的死产，挪威为0.4%），妊娠长度(中位数[IQR]，以天为单位，SIDIAP: 273 [56-280]；挪威：280[273-286])，婴儿数量（挪威：758 806），出生体重（以克为单位的中位数[IQR]，挪威：3520[3175-3860]），以及其他相关变量。讨论和结论：我们开发并实施了围产期扩展，该扩展捕获围产期研究的重要变量，并允许与OMOP-CDM中的现有表进行互操作性，这有望促进未来的网络研究。公开可用的诊断包可以测试扩展表的执行情况，以及映射到OMOP CDM的数据库中关于妊娠和妊娠相关结果的现有数据的质量和完整性。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Pharmacoepidemiology and Drug Safety 医学-药学

CiteScore

4.80

自引率

7.70%

发文量

173

审稿时长

3 months

期刊介绍： The aim of Pharmacoepidemiology and Drug Safety is to provide an international forum for the communication and evaluation of data, methods and opinion in the discipline of pharmacoepidemiology. The Journal publishes peer-reviewed reports of original research, invited reviews and a variety of guest editorials and commentaries embracing scientific, medical, statistical, legal and economic aspects of pharmacoepidemiology and post-marketing surveillance of drug safety. Appropriate material in these categories may also be considered for publication as a Brief Report. Particular areas of interest include: design, analysis, results, and interpretation of studies looking at the benefit or safety of specific pharmaceuticals, biologics, or medical devices, including studies in pharmacovigilance, postmarketing surveillance, pharmacoeconomics, patient safety, molecular pharmacoepidemiology, or any other study within the broad field of pharmacoepidemiology; comparative effectiveness research relating to pharmaceuticals, biologics, and medical devices. Comparative effectiveness research is the generation and synthesis of evidence that compares the benefits and harms of alternative methods to prevent, diagnose, treat, and monitor a clinical condition, as these methods are truly used in the real world; methodologic contributions of relevance to pharmacoepidemiology, whether original contributions, reviews of existing methods, or tutorials for how to apply the methods of pharmacoepidemiology; assessments of harm versus benefit in drug therapy; patterns of drug utilization; relationships between pharmacoepidemiology and the formulation and interpretation of regulatory guidelines; evaluations of risk management plans and programmes relating to pharmaceuticals, biologics and medical devices.