Janssen Research & Development, 1125 Trenton-Harbourton Rd, Titusville, NJ, 08560, USA.
BMC Med Res Methodol. 2023 Oct 21;23(1):246. doi: 10.1186/s12874-023-02073-6.
Administrative healthcare claims databases are used in drug safety research but are limited for investigating the impacts of prenatal exposures on neonatal and pediatric outcomes without mother-infant pair identification. Further, existing algorithms are not transportable across data sources. We developed a transportable mother-infant linkage algorithm and evaluated it in two, large US commercially insured populations.
We used two US commercial health insurance claims databases during the years 2000 to 2021. Mother-infant links were constructed where persons of female sex 12-55 years of age with a pregnancy episode ending in live birth were associated with a person who was 0 years of age at database entry, who shared a common insurance plan ID, had overlapping insurance coverage time, and whose date of birth was within ± 60-days of the mother's pregnancy episode live birth date. We compared the characteristics of linked vs. non-linked mothers and infants to assess similarity.
The algorithm linked 3,477,960 mothers to 4,160,284 infants in the two databases. Linked mothers and linked infants comprised 73.6% of all mothers and 49.1% of all infants, respectively. 94.9% of linked infants' dates of birth were within ± 30-days of the associated mother's pregnancy episode end dates. Characteristics were largely similar in linked vs. non-linked mothers and infants. Differences included that linked mothers were older, had longer pregnancy episodes, and had greater post-pregnancy observation time than mothers with live births who were not linked. Linked infants had less observation time and greater healthcare utilization than non-linked infants.
We developed a mother-infant linkage algorithm and applied it to two US commercial healthcare claims databases that achieved a high linkage proportion and demonstrated that linked and non-linked mother and infant cohorts were similar. Transparent, reusable algorithms applied to large databases enable large-scale research on exposures during pregnancy and pediatric outcomes with relevance to drug safety. These features suggest studies using this algorithm can produce valid and generalizable evidence to inform clinical, policy, and regulatory decisions.
行政医疗保健索赔数据库可用于药物安全研究,但由于无法识别母婴对,因此对于调查产前暴露对新生儿和儿科结局的影响存在一定局限性。此外,现有的算法无法跨数据源移植。我们开发了一种可移植的母婴链接算法,并在两个大型美国商业保险人群中进行了评估。
我们使用了两个美国商业健康保险索赔数据库,时间范围为 2000 年至 2021 年。对年龄在 12-55 岁之间、妊娠结局为活产的女性与数据库录入时年龄为 0 岁、共同享有保险计划 ID、保险覆盖时间重叠且出生日期在母亲妊娠结局活产日期 ±60 天内的人进行母婴关联。我们比较了链接和非链接母亲和婴儿的特征,以评估相似性。
该算法将 3477960 名母亲与两个数据库中的 4160284 名婴儿进行了链接。链接的母亲和链接的婴儿分别占所有母亲的 73.6%和所有婴儿的 49.1%。94.9%的链接婴儿的出生日期在相关母亲妊娠结局结束日期的 ±30 天内。链接和非链接母亲和婴儿的特征基本相似。差异包括链接母亲年龄较大、妊娠时间较长且产后观察时间长于未链接的活产母亲。链接婴儿的观察时间较短,医疗保健利用率较高。
我们开发了一种母婴链接算法,并将其应用于两个美国商业医疗保健索赔数据库,该算法实现了高链接比例,并证明了链接和非链接母婴队列具有相似性。应用于大型数据库的透明、可重复使用的算法可实现大规模研究妊娠期间的暴露情况和儿科结局,这与药物安全相关。这些特征表明,使用该算法的研究可以产生有效的、可推广的证据,为临床、政策和监管决策提供信息。