Pharmacoepidemiology and Drug Safety Research Group, Department of Pharmacy, and PharmaTox Research Initiative, Faculty of Mathematics and Natural Sciences, University of Oslo, Oslo, Norway.
Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, USA.
Pharmacoepidemiol Drug Saf. 2020 Sep;29(9):1111-1119. doi: 10.1002/pds.5089. Epub 2020 Aug 3.
To assess the validity of dispensed prescription to classify exposure to medications used episodically during pregnancy, and to explore individual trajectories of episodic medication use across pregnancy, using triptans for migraine as the motivating example.
We compared self-reported triptan use during pregnancy in The Norwegian Mother, Father and Child Cohort Study (MoBa) to dispensed prescriptions in The Norwegian Prescription Database and calculated Cohen's kappa coefficient (κ), sensitivity, specificity and predictive values using MoBa as reference standard. We used group-based trajectory modeling to estimate exposure trajectories in MoBa according to probability of triptan use across pregnancy.
We identified 6051 pregnancies where mothers filled at least one triptan prescription or reported migraine or triptan use in the 6 months before or during pregnancy. Sensitivity of prescribed triptans during pregnancy was low (39.1%), but specificity was quite high (95.4%). Agreement between the two data sources was fair (κ 0.36). We identified three trajectory groups in MoBa including constant-high, decreasing-medium and decreasing-low probability of triptan use across pregnancy.
Using dispensed prescriptions rather than self-report to classify exposure to triptans during pregnancy is likely to result in substantial under-estimation of exposure. In this study, traditional definitions of ever-exposed vs never-exposed failed to capture variations in drug utilization during pregnancy.
评估配药处方的有效性，以对妊娠期间间歇性使用的药物暴露进行分类，并以偏头痛用曲坦类药物为例，探讨妊娠期间间歇性药物使用的个体轨迹。
我们将挪威母亲、父亲和儿童队列研究（MoBa）中报告的妊娠期间曲坦类药物使用情况与挪威处方数据库中的配药处方进行了比较，并使用 MoBa 作为参考标准，计算了 Cohen's kappa 系数（κ）、灵敏度、特异性和预测值。我们使用基于群组的轨迹建模来估计 MoBa 中根据妊娠期间曲坦类药物使用概率的暴露轨迹。
我们确定了 6051 例妊娠，其中母亲至少有一次配药处方，或在妊娠前或妊娠期间的 6 个月内报告偏头痛或使用曲坦类药物。妊娠期间处方曲坦类药物的敏感性较低（39.1%），但特异性很高（95.4%）。两种数据源之间的一致性为中等（κ 0.36）。我们在 MoBa 中确定了三个轨迹组，包括妊娠期间曲坦类药物使用概率持续高、中等降低和低的轨迹组。
使用配药处方而非自我报告来对妊娠期间使用曲坦类药物进行分类，可能会导致暴露情况的大量低估。在这项研究中，传统的暴露定义（曾经暴露与从未暴露）未能捕捉到妊娠期间药物利用的变化。
