Jimin J Lee, Émilie Bortolussi-Courval, Eva Filosa, Soham Rej, Claire Godard-Sebillote, Robyn Tamblyn, Todd C Lee, Emily G McDonald
{"title":"临床试验中不良药物停药事件报告标准:系统综述。","authors":"Jimin J Lee, Émilie Bortolussi-Courval, Eva Filosa, Soham Rej, Claire Godard-Sebillote, Robyn Tamblyn, Todd C Lee, Emily G McDonald","doi":"10.1111/jgs.19457","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Polypharmacy is a major risk factor for adverse drug events (ADEs), which are a common cause of hospitalization, especially among older adults. Deprescribing is a promising strategy to prevent ADEs; however, clinicians may hesitate to deprescribe for fear of causing adverse drug withdrawal events (ADWEs). Collectively, ADWEs are the re-emergence of symptoms or a disease state due to the discontinuation of a medication. Although capturing ADWEs is critical to understanding the complications that might arise from deprescribing, these events may not be routinely or systematically captured in clinical trials.</p><p><strong>Objectives: </strong>We aimed to determine the frequency of ADWE reporting, compare the strengths and limitations of different approaches, and compare the rates of the number of ADWEs detected across trials.</p><p><strong>Methods: </strong>A systematic review was performed following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses checklist. The search strategy was developed with a research librarian, and studies were identified using Ovid Medline, Embase, and the Cochrane Central Register of Controlled Trials from inception to July 2, 2024. We included all randomized controlled trials testing a deprescribing intervention in older adults (mean or median age ≥ 65 years) and analyzed a subsample of the studies reporting ADWEs as an outcome.</p><p><strong>Results: </strong>Among the 139 eligible studies that were identified, only 12 reported an ADWE. These studies utilized 6 approaches to capture ADWEs: Naranjo ADWE Probability Scale; clinical monitoring for specific withdrawal symptoms; identification through ICD-10 codes; identification of ADWEs as a subset of confirmed ADEs; patient/caregiver self-report; and clinical judgment.</p><p><strong>Conclusion: </strong>Results confirmed that few deprescribing studies capture ADWEs and there is a lack of standardized reporting. A harmonized approach to capturing ADWEs with specific criteria could ensure more consistent results in deprescribing trials, improve our understanding of this important outcome, and facilitate future meta-analyses.</p>","PeriodicalId":94112,"journal":{"name":"Journal of the American Geriatrics Society","volume":" ","pages":""},"PeriodicalIF":0.0000,"publicationDate":"2025-03-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Criteria to Report Adverse Drug Withdrawal Events in Clinical Trials: A Systematic Review.\",\"authors\":\"Jimin J Lee, Émilie Bortolussi-Courval, Eva Filosa, Soham Rej, Claire Godard-Sebillote, Robyn Tamblyn, Todd C Lee, Emily G McDonald\",\"doi\":\"10.1111/jgs.19457\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Polypharmacy is a major risk factor for adverse drug events (ADEs), which are a common cause of hospitalization, especially among older adults. Deprescribing is a promising strategy to prevent ADEs; however, clinicians may hesitate to deprescribe for fear of causing adverse drug withdrawal events (ADWEs). Collectively, ADWEs are the re-emergence of symptoms or a disease state due to the discontinuation of a medication. Although capturing ADWEs is critical to understanding the complications that might arise from deprescribing, these events may not be routinely or systematically captured in clinical trials.</p><p><strong>Objectives: </strong>We aimed to determine the frequency of ADWE reporting, compare the strengths and limitations of different approaches, and compare the rates of the number of ADWEs detected across trials.</p><p><strong>Methods: </strong>A systematic review was performed following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses checklist. The search strategy was developed with a research librarian, and studies were identified using Ovid Medline, Embase, and the Cochrane Central Register of Controlled Trials from inception to July 2, 2024. We included all randomized controlled trials testing a deprescribing intervention in older adults (mean or median age ≥ 65 years) and analyzed a subsample of the studies reporting ADWEs as an outcome.</p><p><strong>Results: </strong>Among the 139 eligible studies that were identified, only 12 reported an ADWE. These studies utilized 6 approaches to capture ADWEs: Naranjo ADWE Probability Scale; clinical monitoring for specific withdrawal symptoms; identification through ICD-10 codes; identification of ADWEs as a subset of confirmed ADEs; patient/caregiver self-report; and clinical judgment.</p><p><strong>Conclusion: </strong>Results confirmed that few deprescribing studies capture ADWEs and there is a lack of standardized reporting. A harmonized approach to capturing ADWEs with specific criteria could ensure more consistent results in deprescribing trials, improve our understanding of this important outcome, and facilitate future meta-analyses.</p>\",\"PeriodicalId\":94112,\"journal\":{\"name\":\"Journal of the American Geriatrics Society\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2025-03-28\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of the American Geriatrics Society\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1111/jgs.19457\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of the American Geriatrics Society","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1111/jgs.19457","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 0
摘要
背景:多种用药是药物不良事件(ADEs)的主要危险因素,是住院治疗的常见原因,尤其是在老年人中。开处方是预防不良事件的一种有希望的策略;然而,临床医生可能会因为担心引起药物不良戒断事件(ADWEs)而犹豫是否取消处方。总的来说,ADWEs是由于停药导致的症状或疾病状态的重新出现。虽然捕获ADWEs对于理解处方可能引起的并发症至关重要,但这些事件在临床试验中可能无法常规或系统地捕获。目的:我们旨在确定ADWE报告的频率,比较不同方法的优势和局限性,并比较各试验中检测到的ADWE数量的比率。方法:根据系统评价和荟萃分析清单的首选报告项目进行系统评价。检索策略是与研究图书管理员一起制定的,并使用Ovid Medline, Embase和Cochrane Central Register of Controlled Trials从成立到2024年7月2日的研究进行鉴定。我们纳入了所有在老年人(平均或中位年龄≥65岁)中测试处方性干预的随机对照试验,并分析了报告ADWEs为结果的研究的子样本。结果:在139个符合条件的研究中,只有12个报告了ADWE。这些研究使用了6种方法来捕获ADWE: Naranjo ADWE概率尺度;特定戒断症状的临床监测;通过ICD-10代码进行识别;将ADWEs确定为确诊ADEs的一个子集;病人自我报告/照顾者;还有临床判断。结论:结果证实,很少有处方性研究捕捉到ADWEs,并且缺乏标准化的报告。采用统一的方法以特定的标准捕获ADWEs,可以确保在描述试验中获得更一致的结果,提高我们对这一重要结果的理解,并促进未来的荟萃分析。
Criteria to Report Adverse Drug Withdrawal Events in Clinical Trials: A Systematic Review.
Background: Polypharmacy is a major risk factor for adverse drug events (ADEs), which are a common cause of hospitalization, especially among older adults. Deprescribing is a promising strategy to prevent ADEs; however, clinicians may hesitate to deprescribe for fear of causing adverse drug withdrawal events (ADWEs). Collectively, ADWEs are the re-emergence of symptoms or a disease state due to the discontinuation of a medication. Although capturing ADWEs is critical to understanding the complications that might arise from deprescribing, these events may not be routinely or systematically captured in clinical trials.
Objectives: We aimed to determine the frequency of ADWE reporting, compare the strengths and limitations of different approaches, and compare the rates of the number of ADWEs detected across trials.
Methods: A systematic review was performed following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses checklist. The search strategy was developed with a research librarian, and studies were identified using Ovid Medline, Embase, and the Cochrane Central Register of Controlled Trials from inception to July 2, 2024. We included all randomized controlled trials testing a deprescribing intervention in older adults (mean or median age ≥ 65 years) and analyzed a subsample of the studies reporting ADWEs as an outcome.
Results: Among the 139 eligible studies that were identified, only 12 reported an ADWE. These studies utilized 6 approaches to capture ADWEs: Naranjo ADWE Probability Scale; clinical monitoring for specific withdrawal symptoms; identification through ICD-10 codes; identification of ADWEs as a subset of confirmed ADEs; patient/caregiver self-report; and clinical judgment.
Conclusion: Results confirmed that few deprescribing studies capture ADWEs and there is a lack of standardized reporting. A harmonized approach to capturing ADWEs with specific criteria could ensure more consistent results in deprescribing trials, improve our understanding of this important outcome, and facilitate future meta-analyses.