Sarangarm Preeyaporn, Young Bonnie, Rayburn William, Jaiswal Pallavi, Dodd Melanie, Phelan Sharon, Bakhireva Ludmila
Department of Pharmacy, University of New Mexico Hospital, Albuquerque, New Mexico, USA.
Birth Defects Res A Clin Mol Teratol. 2012 Mar;94(3):153-61. doi: 10.1002/bdra.22888. Epub 2012 Jan 18.
BACKGROUND Clinical teratology studies often rely on patient reports of medication use in pregnancy with or without other sources of information. Electronic medical records (EMRs), administrative databases, pharmacy dispensing records, drug registries, and patients' self-reports are all widely used sources of information to assess potential teratogenic effect of medications. The objective of this study was to assess comparability of self-reported and prescription medication data in EMRs for the most common therapeutic classes. METHODS The study population included 404 pregnant women prospectively recruited from five prenatal care clinics affiliated with the University of New Mexico. Self-reported information on prescription medications taken since the last menstrual period (LMP) was obtained by semistructured interviews in either English or Spanish. For validation purposes, EMRs were reviewed to abstract information on medications prescribed between the LMP and the date of the interview. Agreement was estimated by calculating a kappa (κ) coefficient, sensitivity, and specificity. RESULTS In this sample of socially-disadvantaged (i.e., 67.9% high school education or less, 48.5% no health insurance), predominantly Latina (80.4%) pregnant women, antibiotics and antidiabetic agents were the most prevalent therapeutic classes. The agreement between the two sources substantially varied by therapeutic class, with the highest level of agreement seen among antidiabetic and thyroid medications (κ ≥0.8) and the lowest among opioid analgesics (κ = 0.35). CONCLUSIONS Results indicate a high concordance between self-report and prescription data for therapeutic classes used chronically, while poor agreement was observed for medications used intermittently, on an 'as needed" basis, or in short courses.
背景 临床致畸学研究通常依赖于孕妇关于孕期用药的报告，无论是否有其他信息来源。电子病历（EMR）、行政数据库、药房配药记录、药物登记处以及患者的自我报告都是广泛用于评估药物潜在致畸作用的信息来源。本研究的目的是评估电子病历中自我报告的和处方用药数据对于最常见治疗类别的可比性。方法 研究人群包括从新墨西哥大学附属的五家产前护理诊所前瞻性招募的404名孕妇。通过英语或西班牙语的半结构化访谈获取自末次月经（LMP）以来服用的处方药的自我报告信息。为了进行验证，查阅电子病历以提取LMP和访谈日期之间开具的药物信息。通过计算kappa（κ）系数、敏感性和特异性来估计一致性。结果 在这个社会经济地位不利（即67.9%接受高中教育或以下，48.5%没有医疗保险）、主要为拉丁裔（80.4%）的孕妇样本中，抗生素和抗糖尿病药物是最常见的治疗类别。两种信息来源之间的一致性因治疗类别而异，抗糖尿病和甲状腺药物的一致性最高（κ≥0.8），阿片类镇痛药的一致性最低（κ = 0.35）。结论 结果表明，对于长期使用的治疗类别，自我报告数据和处方数据高度一致，而对于按需间歇使用或短期使用的药物，一致性较差。
