Department of Pharmacy and Pharmacology, University of Bath, Claverton Down, Bath, UK.
Drug Saf. 2010 Sep 1;33(9):741-50. doi: 10.2165/11536820-000000000-00000.
Postmarketing teratogen surveillance is essential and requires a data source that can reliably capture a wide range of congenital malformations. The UK General Practice Research Database (GPRD) may have the potential to be used for this kind of surveillance.
To assess the extent to which this database can be used to accurately identify major congenital malformations.
This study was carried out as part of a broader study to compare data on anticonvulsant use and safety in pregnancy between the GPRD and a pregnancy registry. The study period ran from 1 January 1990 until 31 December 2006. Mother-baby pairs where the mother had a record of epilepsy, seizure or convulsion were identified using the GPRD computerized medical records. Infants of mother-baby pairs who had a record of a major congenital malformation were identified. Full photocopied paper medical records were requested from the infant's general practitioner and where this was not possible any data entries consisting of uncoded comments, so-called 'free text', in the electronic GPRD record were requested from the database provider. This additional information was then reviewed in order to determine the extent to which the congenital malformation diagnoses identified via the computerized records could be confirmed or rejected and then classified as being major or minor.
Within the study population of 3869 live mother-baby pairs, 188 potentially major congenital malformations were identified from the GPRD computerized record relating to 161 unique individuals. Using a combination of photocopied medical records and free text it was possible to verify 160 malformations (85.1%) as the malformation indicated by the computerized records; this ranged from 91.7% of those cases verified using photocopied medical records and 77.9% of cases verified using free text. Of the verified congenital malformations, using a combination of computerized data, photocopied medical records and free text, it was possible to classify 78.1% as being major and 15.0% as minor, and this percentage was found to be the same for those cases reviewed by photocopied records and those where free text was used. The proportions of malformations that could be verified and those that could be classified as major or minor were found to vary by malformation class.
The GPRD can be used to ascertain a wide range of congenital malformations. In many cases, when a malformation is identified in the GPRD via the computerized medical records, the malformation is likely to exist. However, in this study a small proportion of identified cases had to be excluded because they had been coded incorrectly or diagnostically ruled out. Therefore, depending on the congenital malformation of interest, verification of such malformations using photocopied medical records or free text is generally recommended.
上市后致畸物监测至关重要，需要一个能够可靠地捕捉广泛先天性畸形的数据源。英国全科医生研究数据库（GPRD）可能具有用于此类监测的潜力。
评估该数据库在准确识别主要先天性畸形方面的程度。
本研究是一项更广泛研究的一部分，旨在比较 GPRD 和妊娠登记处中抗惊厥药物使用和安全性的数据。研究期间为 1990 年 1 月 1 日至 2006 年 12 月 31 日。使用 GPRD 计算机化医疗记录识别出有癫痫、癫痫发作或抽搐记录的母婴对。从母婴对中识别出有主要先天性畸形记录的婴儿。从婴儿的全科医生处请求完整的复印纸质医疗记录，如果无法获得，则从数据库提供商处请求电子 GPRD 记录中包含未编码注释的任何数据条目，即所谓的“自由文本”。然后审查这些额外信息，以确定通过计算机化记录识别的先天性畸形诊断可以在多大程度上得到确认或排除，然后将其分类为主要或次要。
在 3869 例活产母婴对的研究人群中，从与 161 个独特个体相关的 GPRD 计算机化记录中识别出 188 例潜在的主要先天性畸形。使用复印医疗记录和自由文本的组合，可以验证 160 种畸形（85.1%）是计算机化记录中指示的畸形；这一比例范围从使用复印医疗记录验证的 91.7%到使用自由文本验证的 77.9%。在经过验证的先天性畸形中，使用计算机化数据、复印医疗记录和自由文本的组合，可以将 78.1%分类为主要畸形，15.0%分类为次要畸形，并且在通过复印记录审查的病例和使用自由文本的病例中发现这一比例相同。可以验证的畸形比例和可以分类为主要或次要的畸形比例因畸形类别而异。
GPRD 可用于确定广泛的先天性畸形。在许多情况下，当 GPRD 通过计算机化医疗记录识别出一种畸形时，该畸形很可能存在。然而，在这项研究中，一小部分已识别的病例必须被排除，因为它们被错误地编码或诊断排除。因此，根据感兴趣的先天性畸形，通常建议使用复印医疗记录或自由文本对这些畸形进行验证。
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