Medical databases in studies of drug teratogenicity: methodological issues.
Medical databases in studies of drug teratogenicity: methodological issues.
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DOI：
10.2147/clep.s9304
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发表时间：
2010-08-09
影响因子：
3.9
通讯作者：
Pedersen L
中科院分区：
文献类型：
--
作者：
Ehrenstein V;Sørensen HT;Bakketeig LS;Pedersen L
超过一半的孕妇服用处方药，这引起了人们对胎儿安全的担忧。常规收集大量人群数据的医学数据库是解决药物致畸性的队列研究的潜在宝贵资源。其中包括电子病历、行政数据库、人口健康登记和致畸性信息服务。医学数据库可以提高出生缺陷患病率的估计精度，但系统误差仍然是一个潜在的严重问题。在这篇综述中，我们首先提供了一个简单的描述类型的北美和欧洲的医学数据库适用于研究药物的致畸性，然后讨论系统性错误的表现在致畸性研究的基础上，这样的数据库。选择偏差主要源于无法确定所有生殖结果。信息偏倚（错误分类）可能是由于缺乏记录的临床细节或药物使用记录不完整造成的。混杂因素，特别是适应症混杂因素，很少能够排除。掩盖致畸性或制造致畸性假象的偏见可能对儿童和母亲的健康产生不利后果。应量化偏倚，并评估其对研究结果的潜在影响。理论和软件都可用于这种估计。只要方法学问题得到理解和有效处理，计算机化的医学数据库是药物致畸性研究的宝贵数据来源。
More than half of all pregnant women take prescription medications, raising concerns about fetal safety. Medical databases routinely collecting data from large populations are potentially valuable resources for cohort studies addressing teratogenicity of drugs. These include electronic medical records, administrative databases, population health registries, and teratogenicity information services. Medical databases allow estimation of prevalences of birth defects with enhanced precision, but systematic error remains a potentially serious problem. In this review, we first provide a brief description of types of North American and European medical databases suitable for studying teratogenicity of drugs and then discuss manifestation of systematic errors in teratogenicity studies based on such databases. Selection bias stems primarily from the inability to ascertain all reproductive outcomes. Information bias (misclassification) may be caused by paucity of recorded clinical details or incomplete documentation of medication use. Confounding, particularly confounding by indication, can rarely be ruled out. Bias that either masks teratogenicity or creates false appearance thereof, may have adverse consequences for the health of the child and the mother. Biases should be quantified and their potential impact on the study results should be assessed. Both theory and software are available for such estimation. Provided that methodological problems are understood and effectively handled, computerized medical databases are a valuable source of data for studies of teratogenicity of drugs.