Harnessing the Medicaid Analytic eXtract (MAX) to Evaluate Medications in Pregnancy: Design Considerations
Harnessing the Medicaid Analytic eXtract (MAX) to Evaluate Medications in Pregnancy: Design Considerations
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DOI：
10.1371/journal.pone.0067405
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发表时间：
2013-06-26
期刊：
影响因子：
3.7
通讯作者：
Hernandez-Diaz, Sonia
中科院分区：
文献类型：
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作者：
Palmsten, Kristin;Huybrechts, Krista F.;Hernandez-Diaz, Sonia
背景资料：在缺乏临床试验数据的情况下，大型上市后观察性研究对于评估妊娠期间药物的安全性和有效性至关重要。我们在2000-2007年医疗补助分析扩展（MAX）中确定了一组以活产结束的妊娠。在此，我们提供了一个蓝图，以指导研究人员谁希望创建类似的队列从医疗保健利用data.Methods的限制，我们详细描述：在女性年龄12-55，我们确定了怀孕分娩相关的代码从医疗保健利用索赔。我们将怀孕妇女与其子女按州、医疗补助病例编号（家庭标识符）和分娩/出生日期联系起来。然后，我们删除了不准确的联系和重复的记录，并实施了队列资格标准（即，结果：从13，460，273例分娩和22，408，810例儿童观察中，在链接、清理和删除重复记录后，可获得6，107，572例以活产结束的妊娠。链接交付的百分比因州而异，从0到96%。在整个妊娠期间要求符合产妇资格标准后，队列规模降至1，248，875例妊娠，在进一步应用婴儿资格标准后，队列规模降至1，173，280例妊娠。百分之九十一的妇女分发至少一种药物在pregnancy.Conclusions：母婴联动是可行的，并产生一个大的怀孕队列，虽然规模随着资格要求的增加而减少。MAX是一个有用的资源，用于研究怀孕期间的药物治疗以及参加医疗补助的贫困妇女及其婴儿的孕产妇和婴儿结局。它也可以用来研究产妇的特点，医疗补助政策的影响，以及怀孕期间的医疗保健利用。然而，必须仔细注意这些数据的局限性，以减少偏差。
Background: In the absence of clinical trial data, large post-marketing observational studies are essential to evaluate the safety and effectiveness of medications during pregnancy. We identified a cohort of pregnancies ending in live birth within the 2000-2007 Medicaid Analytic eXtract (MAX). Herein, we provide a blueprint to guide investigators who wish to create similar cohorts from healthcare utilization data and we describe the limitations in detail.Methods: Among females ages 12-55, we identified pregnancies using delivery-related codes from healthcare utilization claims. We linked women with pregnancies to their offspring by state, Medicaid Case Number (family identifier) and delivery/birth dates. Then we removed inaccurate linkages and duplicate records and implemented cohort eligibility criteria (i.e., continuous and appropriate enrollment type, no private insurance, no restricted benefits) for claim information completeness.Results: From 13,460,273 deliveries and 22,408,810 child observations, 6,107,572 pregnancies ending in live birth were available after linkage, cleaning, and removal of duplicate records. The percentage of linked deliveries varied greatly by state, from 0 to 96%. The cohort size was reduced to 1,248,875 pregnancies after requiring maternal eligibility criteria throughout pregnancy and to 1,173,280 pregnancies after further applying infant eligibility criteria. Ninety-one percent of women were dispensed at least one medication during pregnancy.Conclusions: Mother-infant linkage is feasible and yields a large pregnancy cohort, although the size decreases with increasing eligibility requirements. MAX is a useful resource for studying medications in pregnancy and a spectrum of maternal and infant outcomes within the indigent population of women and their infants enrolled in Medicaid. It may also be used to study maternal characteristics, the impact of Medicaid policy, and healthcare utilization during pregnancy. However, careful attention to the limitations of these data is necessary to reduce biases.