最佳做法比例失调分析中的协变量调整注意事项。

IF 4 2区 医学 Q1 PHARMACOLOGY & PHARMACY
Yoshihiro Noguchi, Tomoya Tachi, Tomoaki Yoshimura
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引用次数: 0

摘要

自发报告系统(SRS)为检测临床试验中未发现的不良事件以及开展准确反映真实临床实践的安全性评估提供了宝贵的数据。随着越来越多的出版物使用自发报告系统进行比例失调分析(DA),人们越来越需要全面了解与自发报告系统相关的研究局限性。然而,人们对在 SRS 分析中调整协变量的相关注意事项缺乏了解。在此,我们总结了共变量调整的使用及其在数据分析中的注意事项。国际医学科学组织理事会第八次会议建议,当分层等调整措施可以提高统计分析的灵敏度和/或特异性时,应考虑使用这些措施。然而,在对 SRS 中的协变量进行调整时,也发现了一些特定于数据库的统计注意事项。比例失调分析不仅可能受到入选时报告偏差的影响,还可能受到入选报告数量变化导致的稀疏数据偏差的影响。要确定在哪些情况下以及在多大程度上灵敏度和/或特异性会受到影响,还需要统计证据。不过,研究人员必须承认,在此背景下讨论的某些局限性可能是固有的,无法纠正。基于这一认识,研究人员就可以就是否进行协变量调整做出明智的决定。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Caveats of Covariate Adjustment in Disproportionality Analysis for Best Practices.

Spontaneous reporting systems (SRS) provide valuable data for detecting unidentified adverse events not observed in clinical trials and for conducting safety assessments that accurately reflect real-world clinical practice. With the increasing number of publications using the SRS for disproportionality analysis (DA), there is an increasing demand for a comprehensive understanding of the research limitations associated with the SRS. However, there is a lack of understanding of the caveats associated with adjusting covariates in DA of the SRS. Herein, we summarized the use of covariate adjustment and its caveats in DA. The Council for International Organizations of Medical Sciences VIII suggests considering adjustments such as stratification when they can enhance the sensitivity and/or specificity of statistical analysis. However, several database-specific and statistical caveats have been identified when adjusting for covariates derived from the SRS. Disproportionality analysis may be affected not only by reporting bias at the time of enrollment but also by sparse-data bias due to variations in the number of enrollment reports. Statistical evidence is needed to determine in which cases and to what extent sensitivity and/or specificity are affected. Nevertheless, it is important for researchers to acknowledge that certain limitations discussed in this context may be inherent and cannot be rectified. Based on this understanding, they can then make an informed decision on whether to perform a covariate adjustment.

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来源期刊
Drug Safety
Drug Safety 医学-毒理学
CiteScore
7.60
自引率
7.10%
发文量
112
审稿时长
6-12 weeks
期刊介绍: Drug Safety is the official journal of the International Society of Pharmacovigilance. The journal includes: Overviews of contentious or emerging issues. Comprehensive narrative reviews that provide an authoritative source of information on epidemiology, clinical features, prevention and management of adverse effects of individual drugs and drug classes. In-depth benefit-risk assessment of adverse effect and efficacy data for a drug in a defined therapeutic area. Systematic reviews (with or without meta-analyses) that collate empirical evidence to answer a specific research question, using explicit, systematic methods as outlined by the PRISMA statement. Original research articles reporting the results of well-designed studies in disciplines such as pharmacoepidemiology, pharmacovigilance, pharmacology and toxicology, and pharmacogenomics. Editorials and commentaries on topical issues. Additional digital features (including animated abstracts, video abstracts, slide decks, audio slides, instructional videos, infographics, podcasts and animations) can be published with articles; these are designed to increase the visibility, readership and educational value of the journal’s content. In addition, articles published in Drug Safety Drugs may be accompanied by plain language summaries to assist readers who have some knowledge of, but not in-depth expertise in, the area to understand important medical advances.
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