The Methodological Quality of Observational Studies Examining the Risk of Pregnancy Drug Use on Congenital Malformations Needs Substantial Improvement: A Cross-Sectional Survey.

IF 4 2区 医学 Q1 PHARMACOLOGY & PHARMACY Drug Safety Pub Date : 2024-11-01 Epub Date: 2024-08-02 DOI:10.1007/s40264-024-01465-x
Yulong Jia, Jing Wang, Chunrong Liu, Peng Zhao, Yan Ren, Yiquan Xiong, GuoWei Li, Meng Chen, Xin Sun, Jing Tan
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Abstract

Background and objective: An increasing number of observational studies have investigated the risk of using drugs during pregnancy on congenital malformations. However, the credibility of the causal relationships drawn from these studies remains uncertain. This study aims to evaluate the potential methodological issues in existing observational studies.

Methods: We used a stepwise approach to investigate this issue. First, we identified observational studies published in 2020 that examined the risk of congenital malformations associated with medication use during pregnancy. We assessed the methodological characteristics for establishing causality, including study design, confounding control, and sensitivity analysis, and compared them between "core clinical journals" and "general journals." For studies reporting an increased risk of congenital malformations in core clinical journals, we searched for subsequent studies addressing the same research question published between January 2021 and May 2023 to assess the consistency of the literature.

Results: A total of 40 eligible studies were published in 2020, primarily focused on the safety of vitamin B12 and folic acid (n = 4), antidepressants (n = 4), and others (n = 32). Our findings suggest that only two (5.00%) studies used causal models to guide the identification of confounding, and only eight (20.00%) studies assessed the potential dose-response relationship. In all, 15 (37.50%) studies used propensity score analysis strategy to achieve "mimic-randomization." In addition, 22 studies (55.00%) performed sensitivity analyses, while 10 (45.45%) showed inconsistency with the primary outcome. Furthermore, 5 studies reported positive outcomes, whereas only 1 out of 11 studies demonstrated a positive correlation between drug usage during pregnancy and major malformations in subsequent studies.

Conclusion: A significant portion of the studies has failed to sufficiently consider the essential methodological characteristics required to improve the credibility of causal inferences. The increased risk of congenital malformations documented in core clinical journal was not adequately replicated in subsequent studies.

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妊娠用药对先天性畸形风险的观察性研究的方法学质量有待大幅提高:一项横断面调查。
背景和目的:越来越多的观察性研究调查了孕期用药对先天性畸形的风险。然而,这些研究得出的因果关系的可信度仍不确定。本研究旨在评估现有观察性研究中潜在的方法学问题:我们采用循序渐进的方法来研究这一问题。首先,我们确定了 2020 年发表的观察性研究,这些研究探讨了与孕期用药相关的先天性畸形风险。我们评估了确定因果关系的方法学特征,包括研究设计、混杂控制和敏感性分析,并在 "核心临床期刊 "和 "一般期刊 "之间进行了比较。对于核心临床期刊中报告先天性畸形风险增加的研究,我们检索了2021年1月至2023年5月期间发表的针对同一研究问题的后续研究,以评估文献的一致性:2020年共发表了40篇符合条件的研究,主要集中在维生素B12和叶酸(4篇)、抗抑郁药(4篇)和其他药物(32篇)的安全性方面。我们的研究结果表明,只有两项(5.00%)研究使用因果模型来指导混杂因素的识别,只有八项(20.00%)研究评估了潜在的剂量-反应关系。总共有 15 项(37.50%)研究使用倾向得分分析策略来实现 "模拟随机"。此外,22 项研究(55.00%)进行了敏感性分析,10 项研究(45.45%)的主要结果不一致。此外,有 5 项研究报告了积极的结果,而 11 项研究中只有 1 项在后续研究中证实了孕期用药与重大畸形之间的正相关性:结论:相当一部分研究没有充分考虑到提高因果推论可信度所需的基本方法学特征。核心临床期刊中记录的先天性畸形风险增加在后续研究中没有得到充分证实。
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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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