{"title":"最佳做法比例失调分析中的协变量调整注意事项。","authors":"Yoshihiro Noguchi, Tomoya Tachi, Tomoaki Yoshimura","doi":"10.1007/s40264-024-01473-x","DOIUrl":null,"url":null,"abstract":"<p><p>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.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":null,"pages":null},"PeriodicalIF":4.0000,"publicationDate":"2024-08-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Caveats of Covariate Adjustment in Disproportionality Analysis for Best Practices.\",\"authors\":\"Yoshihiro Noguchi, Tomoya Tachi, Tomoaki Yoshimura\",\"doi\":\"10.1007/s40264-024-01473-x\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>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.</p>\",\"PeriodicalId\":11382,\"journal\":{\"name\":\"Drug Safety\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":4.0000,\"publicationDate\":\"2024-08-17\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Drug Safety\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1007/s40264-024-01473-x\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"PHARMACOLOGY & PHARMACY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Drug Safety","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1007/s40264-024-01473-x","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"PHARMACOLOGY & PHARMACY","Score":null,"Total":0}
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.
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.