Optum, 1325 Boylston Street, 11th Floor, Boston, MA, 02215, USA.
AbbVie, Inc, North Chicago, IL, USA.
Drug Saf. 2023 Feb;46(2):209-222. doi: 10.1007/s40264-022-01261-5. Epub 2023 Jan 19.
Validation studies of algorithms for pregnancy outcomes based on International Classification of Diseases, 10th Revision, Clinical Modification (ICD-10-CM) codes are important for conducting drug safety research using administrative claims databases. To facilitate the conduct of pregnancy safety studies, this exploratory study aimed to develop and validate ICD-10-CM-based claims algorithms for date of last menstrual period (LMP) and pregnancy outcomes using medical records.
Using a mother-infant-linked claims database, the study included women with a pregnancy between 2016-2017 and their infants. Claims-based algorithms for LMP date utilized codes for gestational age (Z3A codes). The primary outcomes were major congenital malformations (MCMs) and spontaneous abortion; additional secondary outcomes were also evaluated. Each pregnancy outcome was identified using a claims-based simple algorithm, defined as presence of ≥ 1 claim for the outcome. Positive predictive values (PPV) and 95% confidence intervals (CI) were calculated.
Overall, 586 medical records were sought and 365 (62.3%) were adjudicated, including 125 records each for MCMs and spontaneous abortion. Last menstrual period date was validated among maternal charts procured for pregnancy outcomes and fewer charts were adjudicated for the secondary outcomes. The median difference in days between LMP date based on Z3A codes and adjudicated LMP date was 4.0 (interquartile range: 2.0-10.0). The PPV of the simple algorithm for spontaneous abortion was 84.7% (95% CI 78.3, 91.2). The PPV for the MCM algorithm was < 70%. The algorithms for the secondary outcomes pre-eclampsia, premature delivery, and low birthweight performed well, with PPVs > 70%.
The ICD-10-CM claims-based algorithm for spontaneous abortion performed well and may be used in pregnancy studies. Further algorithm refinement for MCMs is needed. The algorithms for LMP date and the secondary outcomes would benefit from additional validation in a larger sample.
基于国际疾病分类第 10 次修订版临床修订版 (ICD-10-CM) 编码的妊娠结局算法的验证研究对于使用行政索赔数据库进行药物安全性研究非常重要。为了便于进行妊娠安全性研究，本探索性研究旨在使用病历开发和验证基于 ICD-10-CM 的索赔算法，以确定末次月经 (LMP) 日期和妊娠结局。
使用母婴关联索赔数据库，本研究纳入了 2016-2017 年期间妊娠的女性及其婴儿。基于索赔的 LMP 日期算法利用了孕龄 (Z3A 代码) 的代码。主要结局是主要先天性畸形 (MCM) 和自然流产；还评估了其他次要结局。每个妊娠结局均使用基于索赔的简单算法确定，定义为存在≥1 次该结局的索赔。计算阳性预测值 (PPV) 和 95%置信区间 (CI)。
总共寻求了 586 份病历，其中 365 份 (62.3%) 进行了裁决，包括 MCM 和自然流产各 125 份。在获取妊娠结局的产妇病历中验证了末次月经日期，而对于次要结局，裁决的病历较少。基于 Z3A 代码的末次月经日期与裁决的末次月经日期之间的天数中位数差异为 4.0(四分位距：2.0-10.0)。自然流产简单算法的 PPV 为 84.7%(95%CI 78.3,91.2)。MCM 算法的 PPV<70%。子痫前期、早产和低出生体重的次要结局算法表现良好，PPV>70%。
基于 ICD-10-CM 的索赔算法的自然流产算法表现良好，可用于妊娠研究。需要进一步改进 MCM 的算法。需要在更大的样本中进一步验证 LMP 日期和次要结局的算法。
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