Evidence map›Paper›PMID 39093543›Full record

ArticleDrug safety2024

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

Yulong Jia, Jing Wang, Chunrong Liu, Peng Zhao, Yan Ren, Yiquan Xiong, GuoWei Li, Meng Chen, Xin Sun, Jing Tan

Abstract read
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In one paragraph

Article in Drug safety, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

Yulong JiaInstitute of Integrated Traditional Chinese and Western Medicine and Chinese Evidence-based Medicine Center, West China Hospital, Sichuan University, No. 37, Guoxue Lane, Wuhou District, Chengdu, 610041, China.
Jing WangInstitute of Integrated Traditional Chinese and Western Medicine and Chinese Evidence-based Medicine Center, West China Hospital, Sichuan University, No. 37, Guoxue Lane, Wuhou District, Chengdu, 610041, China.
Chunrong LiuInstitute of Integrated Traditional Chinese and Western Medicine and Chinese Evidence-based Medicine Center, West China Hospital, Sichuan University, No. 37, Guoxue Lane, Wuhou District, Chengdu, 610041, China.
Peng ZhaoInstitute of Integrated Traditional Chinese and Western Medicine and Chinese Evidence-based Medicine Center, West China Hospital, Sichuan University, No. 37, Guoxue Lane, Wuhou District, Chengdu, 610041, China.
Yan RenInstitute of Integrated Traditional Chinese and Western Medicine and Chinese Evidence-based Medicine Center, West China Hospital, Sichuan University, No. 37, Guoxue Lane, Wuhou District, Chengdu, 610041, China.
Yiquan XiongInstitute of Integrated Traditional Chinese and Western Medicine and Chinese Evidence-based Medicine Center, West China Hospital, Sichuan University, No. 37, Guoxue Lane, Wuhou District, Chengdu, 610041, China.
GuoWei LiDepartment of Health Research Methods, Evidence, and Impact (HEI), McMaster University, Hamilton, ON, Canada.
Meng ChenDepartment of Obstetrics and Gynecology, and Key Laboratory of Birth Defects and Related Diseases of Women and Children (Sichuan University), Ministry of Education, Chengdu, 610041, Sichuan, China.
Xin SunInstitute of Integrated Traditional Chinese and Western Medicine and Chinese Evidence-based Medicine Center, West China Hospital, Sichuan University, No. 37, Guoxue Lane, Wuhou District, Chengdu, 610041, China. sunxin@wchscu.cn.
Jing TanInstitute of Integrated Traditional Chinese and Western Medicine and Chinese Evidence-based Medicine Center, West China Hospital, Sichuan University, No. 37, Guoxue Lane, Wuhou District, Chengdu, 610041, China. tanjing_wch@scu.edu.cn.ORCID http://orcid.org/0000-0001-8839-6705

Funding

National Natural Science Foundation of China 71974138National Natural Science Foundation of China 72174132National Science Fund for Distinguished Young Scholars 82225049Sichuan Provincial Central Government Guides Local Science and Technology Development Special Project 2022ZYD0127
6 · The paper itself

Abstract

BACKGROUND AND

objectiveAn 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.

methodsWe 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.

resultsA total of 40 eligible studies were published in 2020, primarily focused on the safety of vitamin B

conclusionA 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.

Indexed as

Abnormalities, Drug-InducedObservational Studies as TopicCongenital AbnormalitiesCross-Sectional StudiesFemaleHumansPregnancyResearch Design

Identifiers

PMID39093543

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.