Validating Claims-Based Algorithms Determining Pregnancy Outcomes and Gestational Age Using a Linked Claims-Electronic Medical Record Database.

Validating Claims-Based Algorithms Determining Pregnancy Outcomes and Gestational Age Using a Linked Claims-Electronic Medical Record Database.
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DOI:
10.1007/s40264-021-01113-8
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发表时间:
2021-11
期刊:
影响因子:
4.2
通讯作者:
Anderson S
Anderson S
中科院分区:
医学2区
文献类型:
--
作者:
Moll K;Wong HL;Fingar K;Hobbi S;Sheng M;Burrell TA;Eckert LO;Munoz FM;Baer B;Shoaibi A;Anderson S

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妊娠结局的识别和准确估计孕龄(GA)是孕妇药物安全性研究的关键。基于国际疾病分类第十次修订版临床修改/程序编码系统(ICD-10-CM/PCS)的有效妊娠结局算法此前尚未发表。我们开发了算法来对妊娠结局进行分类,并使用ICD-10-CM/PCS和2016-2018 IBM® MarketScan® Explorys® Claims-EMR数据集中索赔的服务代码估计GA,并将结果与电子病历(EMR)的妇产科裁定进行比较。产科服务被分组到使用层次和间距要求集。GA基于具有最高临床准确性的证据。在产科EMR妊娠中,选择100例足月活产(FTB)、100例早产活产(PTB)、100例自然流产(SA)和24例死产进行审查。医生使用适用于结构化EMR的妊娠期免疫接种安全性评估全球一致性(GAIA)定义裁定病例。基于索赔的算法确定了34,204例妊娠,其中9.9%有产科EMR。在抽样妊娠中,判定了92例FTB、93例PTB、75例SA和24例死产。在这些妊娠中,FTB、PTB、SA和死产的一致率分别为97.8%、62.4%、100.0%和70.8%。7天和28天内GA的一致率分别为85.9%和100.0%(FTB),81.7%和98.9%(PTB),61.3%和94.7%(SA),66.7%和79.2%(死产)。妊娠结局算法与EMR的医生裁定高度一致,并可为上市后母体安全性监测提供信息。在线版本包含补充材料,可通过10.1007/s40264-021-01113-8获得。
Pregnancy outcome identification and precise estimates of gestational age (GA) are critical in drug safety studies of pregnant women. Validated pregnancy outcome algorithms based on the International Classification of Diseases, Tenth Revision, Clinical Modification/Procedure Coding System (ICD-10-CM/PCS) have not previously been published. We developed algorithms to classify pregnancy outcomes and estimate GA using ICD-10-CM/PCS and service codes on claims in the 2016–2018 IBM® MarketScan® Explorys® Claims-EMR Data Set and compared the results with ob-gyn adjudication of electronic medical records (EMRs). Obstetric services were grouped into episodes using hierarchical and spacing requirements. GA was based on evidence with the highest clinical accuracy. Among pregnancies with obstetric EMRs, 100 full-term live births (FTBs), 100 preterm live births (PTBs), 100 spontaneous abortions (SAs), and 24 stillbirths were selected for review. Physicians adjudicated cases using Global Alignment of Immunization safety Assessment in pregnancy (GAIA) definitions applied to structured EMRs. The claims-based algorithms identified 34,204 pregnancies, of which 9.9% had obstetric EMRs. Of sampled pregnancies, 92 FTBs, 93 PTBs, 75 SAs, and 24 stillbirths were adjudicated. Among these pregnancies, the percent agreement was 97.8%, 62.4%, 100.0%, and 70.8% for FTBs, PTBs, SAs, and stillbirths, respectively. The percent agreement on GA within 7 and 28 days, respectively, was 85.9% and 100.0% for FTBs, 81.7% and 98.9% for PTBs, 61.3% and 94.7% for SAs, and 66.7% and 79.2% for stillbirths. The pregnancy outcome algorithms had high agreement with physician adjudication of EMRs and may inform post-market maternal safety surveillance. The online version contains supplementary material available at 10.1007/s40264-021-01113-8.
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