Teratogenic Risk Impact Mitigation (TRIM): Development of Explicit Criteria to Facilitate Decisions Regarding Teratogenic Risk Mitigation Strategies.

IF 3.8 2区 医学 Q1 PHARMACOLOGY & PHARMACY
Celeste L Y Ewig, Yanning Wang, Nicole E Smolinski, Gita A Toyserkani, Cynthia LaCivita, Leila Lackey, Sara Eggers, Leyla Sahin, Reem S Abu-Rustum, Brian T Bateman, Anick Berard, Christina D Chambers, Beth Choby, Elizabeth A Conover, Michael F Greene, Sonia Hernández-Díaz, Denise J Jamieson, Sarah G Običan, Janine E Polifka, Kay Roussos-Ross, Jeanne S Sheffield, Sharon Voyer Lavigne, Ellen M Zimmermann, Susan B Laffan, Anthony M DeLise, Alicia W Gilsenan, Tarek A Hammad, Christian Hampp, Janet R Hardy, Caitlin A Knox, Kristine Shields, Meredith Y Smith, Rachel E Sobel, Melissa S Tassinari, Judith C Maro, Sonja A Rasmussen, Almut G Winterstein
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引用次数: 0

Abstract

Background: Preventing fetal exposure to teratogenic medications is an important target for risk mitigation efforts. Decisions about risk mitigation efforts specific to teratogenic medications are complex.

Objectives: The Teratogenic Risk Impact and Mitigation (TRIM) tool was developed as an innovative decision support tool to facilitate prioritization of teratogenic medications for risk mitigation strategies.

Methods: We employed a modified Delphi study design involving experts across teratology, obstetrics/gynecology, and medication safety. Panelists proposed decision criteria in three focus groups, followed by e-Delphi rounds to reach a consensus on criteria regarding three dimensions: (1) completeness; (2) relevance; and (3) distinctiveness. Aggregated feedback from each round was used to inform revision of the criteria in subsequent rounds.

Results: A total of 33 candidate criteria proposed by 32 focus group participants were organized into ten distinct criteria for the Delphi process. Consensus (defined as > 85% agreement on all three dimensions) was reached after three e-Delphi rounds, resulting in six criteria: (1) background use among persons of reproductive potential; (2) overall medication benefit considering severity of the indication and availability of alternatives; (3) seriousness of the teratogenic outcome; (4) risk of the teratogenic outcome; (5) certainty regarding teratogenicity; and (6) the risk of exposure during pregnancy.

Conclusions: We established measurable criteria to inform decisions when prioritizing teratogenic medications for risk mitigation programs. Criteria are consensus based and consistent with relevant regulatory guidance. Future work will operationalize these criteria and determine specific weights to facilitate medication-specific TRIM scores. Through its explicit framework, the TRIM tool may support consistent, transparent, and rational decision making and help optimize the contribution of risk mitigation programs to public health.

减轻致畸风险影响(TRIM):制定明确的标准以促进有关减轻致畸风险战略的决策。
背景:预防胎儿接触致畸药物是降低风险努力的重要目标。关于降低致畸药物风险的决定是复杂的。目的:致畸风险影响和缓解(TRIM)工具是作为一种创新的决策支持工具开发的,以促进在风险缓解战略中优先考虑致畸药物。方法:我们采用了一种改进的德尔菲研究设计,包括畸形学、产科/妇科和药物安全方面的专家。小组成员在三个焦点小组中提出决策标准,随后进行e-Delphi轮询,以就三个维度的标准达成共识:(1)完整性;(2)相关性;(3)显著性。每一轮的综合反馈被用来为随后几轮的标准修订提供信息。结果:32个焦点小组参与者提出的33个候选标准被组织成10个不同的德尔菲过程标准。经过三轮e-Delphi后,达成了共识(定义为在所有三个维度上达成85%的一致),产生了六个标准:(1)生殖潜力人群的背景使用;(2)综合考虑适应症的严重程度和替代药物的可获得性的总体用药获益;(三)致畸后果的严重程度;(4)致畸结局的风险;(五)致畸性的确定性;(6)妊娠期暴露的风险。结论:我们建立了可测量的标准,以便在风险缓解方案中优先考虑致畸药物时为决策提供信息。标准是基于共识的,并与相关的监管指导一致。未来的工作将对这些标准进行操作,并确定具体权重,以促进特定药物的TRIM评分。通过其明确的框架,TRIM工具可以支持一致、透明和合理的决策,并有助于优化风险缓解规划对公共卫生的贡献。
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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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