Theresa Burkard, Kim López-Güell, Artem Gorbachev, Lucía Bellas, Annika M Jödicke, Edward Burn, Maria de Ridder, Mees Mosseveld, Jasmine Gratton, Sarah Seager, Dina Vojinovic, Miguel Angel Mayer, Juan Manuel Ramírez-Anguita, Angela Leis Machín, Marek Oja, Raivo Kolde, Klaus Bonadt, Daniel Prieto-Alhambra, Chistian Reich, Martí Català
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Based on DRUG_EXPOSURE data from the primary care databases Clinical Practice Research Datalink GOLD (United Kingdom) and Integrated Primary Care Information (IPCI, The Netherlands) and healthcare claims from PharMetrics® Plus for Academics (USA), we developed four formulas to calculate daily dose given different DRUG_STRENGTH reference table information. We tested the dose formulas by comparing the calculated median daily dose to the World Health Organization (WHO) Defined Daily Dose (DDD) for six different ingredients in those three databases and additional four international databases representing a variety of healthcare settings: MAITT (Estonia, healthcare claims and discharge summaries), IQVIA Disease Analyzer Germany (outpatient data), IQVIA Longitudinal Patient Database Belgium (outpatient data), and IMASIS Parc Salut (Spain, hospital data). Finally, in each database, we assessed the proportion of drug records for which daily dose calculations were possible using the suggested formulas.</p><p><strong>Results: </strong>Applying the dose formulas, we obtained median daily doses that generally matched the WHO DDD definitions. 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引用次数: 0
摘要
目的：我们旨在开发一种标准化方法，仅使用观察性医疗结果合作组织通用数据模型（OMOP CDM）中典型观察数据的药物信息和观察性健康数据科学与信息学（OHDSI）中的单一参考表，在全球范围内计算任何药物的日剂量（即患者每天接触的药物量）：OMOP DRUG_STRENGTH 参考表包含药物强度或浓度信息，而 OMOP DRUG_EXPOSURE 表则包含患者的药物处方或配药/索赔信息。根据来自基层医疗数据库 Clinical Practice Research Datalink GOLD（英国）和 Integrated Primary Care Information（IPCI，荷兰）的 DRUG_EXPOSURE 数据，以及来自 PharMetrics® Plus for Academics（美国）的医疗报销单，我们开发了四种公式，根据不同的 DRUG_STRENGTH 参考表信息计算每日剂量。我们将计算出的日剂量中位数与世界卫生组织 (WHO) 定义的日剂量 (DDD) 进行了比较，从而测试了这三个数据库和另外四个代表不同医疗环境的国际数据库中六种不同成分的剂量公式：MAITT（爱沙尼亚，医疗索赔和出院摘要）、IQVIA Disease Analyzer Germany（门诊病人数据）、IQVIA Longitudinal Patient Database Belgium（门诊病人数据）和 IMASIS Parc Salut（西班牙，医院数据）。最后，在每个数据库中，我们评估了可使用建议公式计算每日剂量的药物记录比例：应用剂量公式计算得出的日剂量中位数基本符合世界卫生组织的 DDD 定义。除一个数据库外，我们的剂量公式适用于所有数据库中超过 85% 的药物记录：我们在 OMOP CDM 中建立并实施了标准化的日剂量计算方法，结果可靠且可重复。
Calculating daily dose in the Observational Medical Outcomes Partnership Common Data Model.
Purpose: We aimed to develop a standardized method to calculate daily dose (i.e., the amount of drug a patient was exposed to per day) of any drug on a global scale using only drug information of typical observational data in the Observational Medical Outcomes Partnership Common Data Model (OMOP CDM) and a single reference table from Observational Health Data Sciences And Informatics (OHDSI).
Materials and methods: The OMOP DRUG_STRENGTH reference table contains information on the strength or concentration of drugs, whereas the OMOP DRUG_EXPOSURE table contains information on patients' drug prescriptions or dispensations/claims. Based on DRUG_EXPOSURE data from the primary care databases Clinical Practice Research Datalink GOLD (United Kingdom) and Integrated Primary Care Information (IPCI, The Netherlands) and healthcare claims from PharMetrics® Plus for Academics (USA), we developed four formulas to calculate daily dose given different DRUG_STRENGTH reference table information. We tested the dose formulas by comparing the calculated median daily dose to the World Health Organization (WHO) Defined Daily Dose (DDD) for six different ingredients in those three databases and additional four international databases representing a variety of healthcare settings: MAITT (Estonia, healthcare claims and discharge summaries), IQVIA Disease Analyzer Germany (outpatient data), IQVIA Longitudinal Patient Database Belgium (outpatient data), and IMASIS Parc Salut (Spain, hospital data). Finally, in each database, we assessed the proportion of drug records for which daily dose calculations were possible using the suggested formulas.
Results: Applying the dose formulas, we obtained median daily doses that generally matched the WHO DDD definitions. Our dose formulas were applicable to >85% of drug records in all but one of the assessed databases.
Conclusion: We have established and implemented a standardized daily dose calculation in OMOP CDM providing reliable and reproducible results.
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.
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