Department of Epidemiology, Biostatistics and HTA, Radboud University Nijmegen Medical Centre, P.O. Box 9101, 6500 HB, Nijmegen, The Netherlands.
Drug Saf. 2013 Jan;36(1):43-54. doi: 10.1007/s40264-012-0004-8.
In case-control studies that assess associations between medication use and birth defects, detailed information on type of medication and timing of use is essential to prevent misclassification. However, data on the accuracy of recall of medication use during pregnancy are scarce.
The aim of this study was to validate a self-administered questionnaire to assess prescription medication use in the 3 months before and during pregnancy.
This validation study was embedded in Eurocat Northern Netherlands, a population-based birth defects registry that covers 10% of all births in The Netherlands. The questionnaire was validated among 560 mothers of infants with major birth defects registered from 1 January 2009 through 30 June 2010 by comparing it with a reference standard consisting of pharmacy data which were checked for compliance by maternal interviews. Sensitivity and specificity were calculated to quantify validity for any prescription medication use, groups of medications and individual medications. In addition, we determined whether maternal characteristics influenced disagreement between the questionnaire and the reference standard using logistic regression analyses.
The sensitivity for any prescription medication use was 0.57, ranging between 0.07 (dermatological corticosteroids) and 0.83 (antihypertensives) for medication groups, and between 0.00 (naproxen) and 0.73 (salbutamol) for individual medications. Overall, specificity was high (0.93-1.00). Smoking during pregnancy and completing the questionnaire>2 years after delivery were associated with increased disagreement between the questionnaire for prescription medication use and the reference standard.
The validity of the self-administered questionnaire for prescription medication use during pregnancy was moderate to poor for most medications and disagreement differed by some maternal characteristics. As many epidemiological studies use similar questionnaires to assess medication use these studies may need additional data sources such as pharmacy records or prescription databases for medication use next to self-reported methods. Also, previous knowledge on the effect of questionnaire design should be taken into account.
在评估药物使用与出生缺陷之间关联的病例对照研究中，详细的药物类型和使用时间信息对于防止分类错误至关重要。然而，关于怀孕期间药物使用回忆准确性的数据却很少。
本研究旨在验证一种自我管理的问卷，以评估怀孕前 3 个月和怀孕期间的处方药使用情况。
这项验证研究嵌入在 Eurocat 荷兰北部，这是一个基于人群的出生缺陷登记处，覆盖荷兰所有出生人口的 10%。该问卷在 2009 年 1 月 1 日至 2010 年 6 月 30 日期间登记的 560 名患有重大出生缺陷的婴儿的母亲中进行了验证，方法是将其与参考标准进行比较，参考标准包括药房数据，这些数据通过母亲访谈进行了合规性检查。计算了敏感性和特异性，以量化任何处方药使用、药物组和个别药物的有效性。此外，我们还使用逻辑回归分析确定了母亲特征是否会影响问卷与参考标准之间的差异。
任何处方药使用的敏感性为 0.57，药物组的范围为 0.07（皮肤科皮质类固醇）至 0.83（抗高血压药），个别药物的范围为 0.00（萘普生）至 0.73（沙丁胺醇）。总体而言，特异性很高（0.93-1.00）。怀孕期间吸烟和在分娩后>2 年完成问卷与问卷中处方药物使用与参考标准之间的差异增加有关。
对于大多数药物，自我管理的怀孕期间处方药使用问卷的有效性为中等至较差，并且差异因一些母亲特征而异。由于许多流行病学研究使用类似的问卷来评估药物使用情况，因此这些研究可能需要额外的数据来源，例如药房记录或处方数据库，以补充自我报告的方法。此外，还应考虑问卷设计效果的先前知识。
