Yuchen Guo, Edward Burn, Annika M Jödicke, Núria Mercadé-Besora, Kim Lopez-Güell, Xihang Chen, Mike Du, Xintong Li, Raivo Kolde, Marek Oja, Mees Mosseveld, Katia Verhamme, Julieta Politi, Antonella Delmestri, Wai Yi Man, Peter Rijnbeek, Daniel Prieto-Alhambra, Martí Català
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引用次数: 0
Abstract
Purpose: To develop and describe DrugUtilisation, an open-source R package that facilitates drug utilisation studies using data mapped to the OMOP Common Data Model (CDM).
Methods: Core functionalities include creating drug user cohorts, identifying and summarising indications, describing the duration and dose of medication/s and assessing treatment adherence. The package works with packages developed within the DARWIN EU initiative to support study-specific workflows. We show the package's workflow by analysing the use of simvastatin in three European real-world databases.
Results: This paper outlines the DrugUtilisation package's functions and demonstrates their application with a clinical example of simvastatin use in databases from the United Kingdom, Estonia and the Netherlands. We generated results including cohort counts, indication summaries, measures of dose and duration, as well as publication-ready tables and figures. We implemented comprehensive unit tests and standardised output format, which ensured consistency across databases and minimised coding errors.
Conclusion: The development of this software allows for researchers to quickly perform common drug utilisation analyses, while also providing the foundation for additional, bespoke study-specific analyses.
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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