Core Concepts in Pharmacoepidemiology: New-User Designs.

IF 2.4 4区医学 Q3 PHARMACOLOGY & PHARMACY

Pharmacoepidemiology and Drug Safety Pub Date : 2024-12-01 DOI:10.1002/pds.70048

Qoua L Her, Julie Rouette, Jessica C Young, Michael Webster-Clark, John Tazare

引用次数: 0

Abstract

In this article, we review the history and key reasons for new-user comparisons in pharmacoepidemiology, highlighting the target trial framework as a unifying framework. We describe three distinct pharmacoepidemiological new-user study designs: (1) new-user versus non-user; (2) active comparator new-user; (i.e., ACNU) and (3) prevalent new-user (i.e., PNU) designs, and discuss how each relates to key issues of defining time zero, choosing appropriate comparator groups, and potential sources of bias they do and do not account for. We use a clinical example of hormone replacement therapy and the risk of coronary heart disease to illustrate practical considerations surrounding the application of the three designs presented.

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药物流行病学的核心概念：新用户设计。

在本文中，我们回顾了药物流行病学中新用户比较的历史和主要原因，强调目标试验框架是一个统一的框架。我们描述了三种不同的药物流行病学新用户研究设计：(1) 新用户与非用户；(2) 活性参照物新用户（即 ACNU）；(3) 流行性新用户（即 PNU）设计，并讨论了每种设计与定义时间零点、选择适当的参照组等关键问题的关系，以及它们考虑和不考虑的潜在偏倚来源。我们使用激素替代疗法和冠心病风险的临床实例来说明应用所介绍的三种设计时的实际考虑因素。

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.