{"title":"Risk prediction models for adverse drug reactions and adverse drug events in older adults-a systematic review and meta-analysis.","authors":"Nicole Cosgrave, Sooad Saleh, Woei Shan Ong, Juliane Frydenlund, David J Williams, Caitriona Cahir","doi":"10.1007/s00228-024-03774-7","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Adverse drug reactions (ADRs) are common and result in significant morbidity, mortality, and associated hospital costs. Models predicting ADRs in older adults were previously found to lack reliability and validity. This systematic review and meta-analysis aim to provide an updated, comprehensive quality assessment and analysis of ADR-risk prediction tools in older adults.</p><p><strong>Methods: </strong>Standard databases and citations were searched (2012 to 2023) and studies which developed and/or validated an ADR prediction model for use in older adults were included. Four studies from a previous systematic review were also included. The TRIPOD (transparent reporting of a multivariable prediction model for individual prognosis or diagnosis) checklist was used to evaluate each study. Random effects models were used to derive a pooled discrimination estimate (area-under-the-receiver-operation curve; AUROC) for model development and validation studies.</p><p><strong>Results: </strong>Eight studies, describing 6 ADR-risk prediction models met the inclusion criteria). In the meta-analysis, the pooled AUROC was 0.75 (95% CI 0.57, 0.87; I-squared = 96.88%) for model development studies and 0.73 (95% CI 0.52, 0.87; Isquared = 90.19%) for externally validated studies. Studies had poor adherence (range 34-50%; median 46.5%; IQR 12%) to TRIPOD guidelines.</p><p><strong>Conclusion: </strong>The studies identified through this systematic review exhibit poor adherence to TRIPOD guidelines which may question the investigational rigor and the usability of the models. This underscores the urgent need to develop a validated, robust, and reliable tool worthy of implementation and testing in a real-world setting to gauge its impact and usability effectively.</p>","PeriodicalId":11857,"journal":{"name":"European Journal of Clinical Pharmacology","volume":" ","pages":"93-110"},"PeriodicalIF":2.4000,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"European Journal of Clinical Pharmacology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1007/s00228-024-03774-7","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/11/18 0:00:00","PubModel":"Epub","JCR":"Q3","JCRName":"PHARMACOLOGY & PHARMACY","Score":null,"Total":0}
引用次数: 0
Abstract
Background: Adverse drug reactions (ADRs) are common and result in significant morbidity, mortality, and associated hospital costs. Models predicting ADRs in older adults were previously found to lack reliability and validity. This systematic review and meta-analysis aim to provide an updated, comprehensive quality assessment and analysis of ADR-risk prediction tools in older adults.
Methods: Standard databases and citations were searched (2012 to 2023) and studies which developed and/or validated an ADR prediction model for use in older adults were included. Four studies from a previous systematic review were also included. The TRIPOD (transparent reporting of a multivariable prediction model for individual prognosis or diagnosis) checklist was used to evaluate each study. Random effects models were used to derive a pooled discrimination estimate (area-under-the-receiver-operation curve; AUROC) for model development and validation studies.
Results: Eight studies, describing 6 ADR-risk prediction models met the inclusion criteria). In the meta-analysis, the pooled AUROC was 0.75 (95% CI 0.57, 0.87; I-squared = 96.88%) for model development studies and 0.73 (95% CI 0.52, 0.87; Isquared = 90.19%) for externally validated studies. Studies had poor adherence (range 34-50%; median 46.5%; IQR 12%) to TRIPOD guidelines.
Conclusion: The studies identified through this systematic review exhibit poor adherence to TRIPOD guidelines which may question the investigational rigor and the usability of the models. This underscores the urgent need to develop a validated, robust, and reliable tool worthy of implementation and testing in a real-world setting to gauge its impact and usability effectively.
期刊介绍:
The European Journal of Clinical Pharmacology publishes original papers on all aspects of clinical pharmacology and drug therapy in humans. Manuscripts are welcomed on the following topics: therapeutic trials, pharmacokinetics/pharmacodynamics, pharmacogenetics, drug metabolism, adverse drug reactions, drug interactions, all aspects of drug development, development relating to teaching in clinical pharmacology, pharmacoepidemiology, and matters relating to the rational prescribing and safe use of drugs. Methodological contributions relevant to these topics are also welcomed.
Data from animal experiments are accepted only in the context of original data in man reported in the same paper. EJCP will only consider manuscripts describing the frequency of allelic variants in different populations if this information is linked to functional data or new interesting variants. Highly relevant differences in frequency with a major impact in drug therapy for the respective population may be submitted as a letter to the editor.
Straightforward phase I pharmacokinetic or pharmacodynamic studies as parts of new drug development will only be considered for publication if the paper involves
-a compound that is interesting and new in some basic or fundamental way, or
-methods that are original in some basic sense, or
-a highly unexpected outcome, or
-conclusions that are scientifically novel in some basic or fundamental sense.