Reliability of Self-Reported Maternal Health and Mother-Infant Outcome Data in Web-Based Questionnaires.

IF 5.9 2区医学 Q1 PHARMACOLOGY & PHARMACY

Drug Safety Pub Date : 2026-09-01 Epub Date: 2026-04-10 DOI:10.1007/s40264-026-01671-9

Laure Sillis, Laura Van Mechelen, Marleen M H J van Gelder, Sien Lenie, Karel Allegaert, Annick Bogaerts, Maarten De Vos, Titia Hompes, Anne Smits, Kristel Van Calsteren, Jan Y Verbakel, Veerle Foulon, Michael Ceulemans

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引用次数: 0

Abstract

Objectives: The BELpREG registry in Belgium collects self-reported real-world data on perinatal medication use and mother-infant outcomes. Given the importance of self-reported data for pregnancy safety studies, this study aims to assess the reliability of maternal health and mother-infant outcome data reported in BELpREG.

Methods: We compared self-reported maternal health and mother-infant outcomes in the BELpREG registry with medical record data from gynaecologists, general practitioners, and midwives. Participants included pregnant women enrolled in BELpREG, aged 18 years or older, who delivered between November 2022 and April 2024 and had medical record data provided by at least one healthcare professional (HCP). Comparisons for continuous variables such as pre-pregnancy body mass index (BMI), gestational age at delivery, and infant metrics at birth were analysed using intraclass correlation coefficients (ICCs). For dichotomous and categorical variables, including pregnancy complications, delivery characteristics, and hospital admissions, we used Cohen's Kappa and observed proportions of positive and negative agreement.

Results: This study included 175 participants with available medical record data. Medical records were mostly returned by gynaecologists (40%) and midwives (25.7%). Reliability was high for pregnancy complications, onset, and mode of delivery. Gestational age showed almost perfect concordance (ICC 0.99). Infant outcomes, including birth metrics and Apgar scores, were highly reliable (ICC > 0.90), with almost perfect categorisation into birth weight percentiles (Cohen's Kappa 0.97). Self-reported maternal BMI exhibited moderate reliability as a continuous measure (ICC 0.75), but almost perfect agreement when categorised (Cohen's Kappa 0.89). The low prevalence of hospital admissions, delivery complications, infant complications, postpartum complications, and birth defects limited the assessment of these outcomes.

Conclusions: The BELpREG registry demonstrated high agreement between self-reported and HCP-reported data for most maternal health and mother-infant outcomes, supporting its use in future pregnancy safety studies.

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基于网络的问卷中自我报告的孕产妇健康和母婴结局数据的可靠性

目的：比利时BELpREG登记处收集围产期药物使用和母婴结局的自我报告的真实数据。鉴于自我报告数据对妊娠安全性研究的重要性，本研究旨在评估BELpREG报告的孕产妇健康和母婴结局数据的可靠性。方法：我们将BELpREG登记处自我报告的孕产妇健康和母婴结局与妇科医生、全科医生和助产士的医疗记录数据进行比较。参与者包括在BELpREG中登记的18岁或以上的孕妇，她们在2022年11月至2024年4月期间分娩，并有至少一名医疗保健专业人员（HCP）提供的医疗记录数据。比较连续变量，如孕前体重指数（BMI）、分娩胎龄和婴儿出生时的指标，使用类内相关系数（ICCs）进行分析。对于二分类变量和分类变量，包括妊娠并发症、分娩特征和住院情况，我们使用Cohen's Kappa并观察到积极和消极一致的比例。结果：本研究纳入175名有可用病历资料的参与者。医疗记录主要由妇科医生（40%）和助产士（25.7%）归还。妊娠并发症、发病和分娩方式的可靠性较高。胎龄几乎完全一致（ICC 0.99）。婴儿结局，包括出生指标和Apgar评分，是高度可靠的（ICC > 0.90），几乎完美地分类到出生体重百分位数（Cohen's Kappa 0.97）。自我报告的母亲BMI在连续测量中表现出中等的可靠性（ICC 0.75），但在分类时几乎完全一致（Cohen’s Kappa 0.89）。住院、分娩并发症、婴儿并发症、产后并发症和出生缺陷的低患病率限制了对这些结果的评估。结论：BELpREG登记显示，在大多数孕产妇健康和母婴结局方面，自我报告的数据与hcp报告的数据高度一致，支持其在未来妊娠安全性研究中的应用。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

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.