Identifying pregnancy episodes, outcomes, and mother-infant pairs in the Vaccine Safety Datalink
Identifying pregnancy episodes, outcomes, and mother-infant pairs in the Vaccine Safety Datalink
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DOI：
10.1016/j.vaccine.2013.03.069
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发表时间：
2013-06-12
期刊：
影响因子：
5.5
通讯作者：
McCarthy, Natalie L.
中科院分区：
文献类型：
--
作者：
Naleway, Allison L.;Gold, Rachel;McCarthy, Natalie L.
背景：研究妊娠期疫苗接种安全性的必要性已得到广泛认可。像疫苗安全数据链（VSD）这样的基于人群的大型数据系统可能对这项研究有用，但使用电子病历（EMR）和索赔数据识别怀孕可能具有挑战性。方法：我们修改了现有的数据处理算法，以确定10个VSD位点中的7个妊娠。我们通过计算该算法与人工病历审查之间在妊娠结局类型、结束日期和胎龄方面的一致性来验证该算法。在每个参与站点，我们在四个结局类型层（活产、自然流产、选择性流产和其他妊娠结局）中随机抽取15例，每个站点共60例。我们还开发并验证了在电子数据中将母亲与其婴儿联系起来的方法。结果：在2002年至2006年期间，我们在12岁至55岁的女性中发现了595,929例妊娠事件。在这些怀孕中，75%是活产，12%是自然流产，9%是选择性流产。对于99%的活产、93%的自然流产、92%的选择性流产和90%的其他结果，我们能够在算法估计的怀孕开始日期的28天内确认怀孕。根据结果类型，算法确定的结果日期与摘要确定的结果日期之间的一致性从70%（选择性流产）到96%（活产）不等。当EMR中可获得胎龄时，根据结果类型，一致性从82%（其他）到98%（活产）不等。我们通过人工病历审查确认了350个样本中100%的母婴联系。结论：VSD算法准确地识别了参与站点的妊娠期和母婴对。根据具体的研究需要，可能需要额外的人工记录审查来提高怀孕日期估计的准确性。这些算法将使我们能够对怀孕期间疫苗接种的安全性进行大规模的、基于人群的研究。(C) 2013 Elsevier Ltd.版权所有。
Background: The need for research on the safety of vaccination during pregnancy is widely recognized. Large, population-based data systems like the Vaccine Safety Datalink (VSD) may be useful for this research, but identifying pregnancies using electronic medical record (EMR) and claims data can be challenging.Methods: We modified an existing data processing algorithm to identify pregnancies within seven of the ten VSD sites. We validated the algorithm by calculating the agreement in pregnancy outcome type, end date, and gestational age between the algorithm and manual medical record review. At each participating site, we randomly sampled 15 episodes within four outcome type strata (live births, spontaneous abortions, elective abortions, and other pregnancy outcomes) for a total of 60 episodes per site. We also developed and validated methods to link mothers to their infants in the electronic data.Results: We identified 595,929 pregnancy episodes ending in 2002 through 2006 among women 12 through 55 years of age. Of these pregnancies, 75% ended in live births, 12% in spontaneous abortions, and 9% in elective abortions. We were able to confirm a pregnancy within 28 days of the algorithm-estimated pregnancy start date for 99% of live births, 93% of spontaneous abortions, 92% of elective abortions, and 90% of other outcomes sampled. The agreement between the algorithm-identified and the abstractor-identified outcome date ranged from 70% (elective abortion) to 96% (live birth) depending on outcome type. When gestational age was available in the EMR, agreement ranged from 82% (other) to 98% (live birth) depending on outcome type. We confirmed 100% of the 350 sampled mother-infant linkages with manual medical record review.Conclusions: The VSD algorithm accurately identifies pregnancy episodes and mother-infant pairs across participating sites. Additional manual record review may be needed to improve the precision of the pregnancy date estimates depending on specific study needs. These algorithms will allow us to conduct large, population-based studies of the safety of vaccination during pregnancy. (C) 2013 Elsevier Ltd. All rights reserved.