Identifying Major Congenital Malformations in the UK General Practice Research Database (GPRD) A Study Reporting on the Sensitivity and Added Value of Photocopied Medical Records and Free Text in the GPRD
Identifying Major Congenital Malformations in the UK General Practice Research Database (GPRD) A Study Reporting on the Sensitivity and Added Value of Photocopied Medical Records and Free Text in the GPRD
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DOI：
10.2165/11536820-000000000-00000
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发表时间：
2010-01-01
期刊：
影响因子：
4.2
通讯作者：
de Vries, Corinne S.
中科院分区：
文献类型：
--
作者：
Charlton, Rachel A.;Weil, John G.;de Vries, Corinne S.
背景资料：上市后致畸剂监测是必不可少的，需要一个能够可靠捕获各种先天性畸形的数据源。英国全科医学研究数据库（GPRD）可能有潜力用于此类监测目的：评估该数据库可用于准确识别主要先天性畸形的程度方法：本研究是一项更广泛研究的一部分，旨在比较GPRD和妊娠登记处之间妊娠期抗惊厥药物使用和安全性的数据。研究期间从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癫痫发作或抽搐。确定了有重大先天畸形记录的母婴对婴儿。要求婴儿的全科医生提供完整的复印纸质病历，如果无法提供，则要求数据库提供商提供电子GPRD记录中包含未编码注释（所谓的“自由文本”）的任何数据条目。然后对这些额外的信息进行审查，以确定通过计算机记录确定的先天性畸形诊断可以被确认或拒绝的程度，然后将其分类为主要或次要结果：在3869对活母婴的研究人群中，从GPRD计算机记录中确定了161个独特个体的188个潜在的主要先天性畸形。使用影印病历和自由文本相结合，有可能验证160例畸形（85.1%）为计算机记录所示的畸形，范围从91.7%的病例使用影印病历验证和77.9%的病例使用自由文本验证。在已证实的先天性畸形中，使用计算机数据、影印的医疗记录和自由文本相结合，可以将78.1%归类为重大畸形，15.0%归类为轻微畸形，通过影印记录和使用自由文本审查的病例中，发现该百分比相同。结论：GPRD可用于确定广泛的先天性畸形。在许多情况下，当通过计算机化病历在GPRD中识别出畸形时。畸形是可能存在的。然而，在这项研究中，一小部分已确定的病例不得不被排除，因为它们被错误编码或诊断排除。因此，根据感兴趣的先天性畸形，通常建议使用影印的医疗记录或自由文本来验证此类畸形
Background: 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 surveillanceObjective: To assess the extent to which this database can be used to accurately identify major congenital malformationsMethods: 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 I 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 minorResults: 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.Conclusions: 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