Dydensborg Sander Stine, Størdal Ketil, Plato Hansen Tine, Nybo Andersen Anne-Marie, Murray Joseph A, Lillevang Søren Thue, Husby Steffen
Hans Christian Andersen Children's Hospital, Odense University Hospital; Institute of Clinical Research, University of Southern Denmark; Odense Patient Data Explorative Network (OPEN), Odense University Hospital, Odense, Denmark.
Mental and Physical Health, Norwegian Institute of Public Health, Oslo; Department of Pediatrics, Ostfold Hospital Trust, Fredrikstad, Norway.
Clin Epidemiol. 2016 Dec 15;8:789-799. doi: 10.2147/CLEP.S122300. eCollection 2016.
The purpose of this study was to validate the celiac disease diagnoses recorded in the Danish National Patient Register. To validate the diagnoses, we used information on duodenal biopsies from a national register of pathology reports (the Patobank) and information on celiac disease-specific antibodies and human leukocyte antigen (HLA) genotypes obtained from patient medical records.
We included all the children who were born from 1995 to 2012 and who were registered as having celiac disease in the Danish National Patient Register. We reviewed all the pathology reports on duodenal biopsies in the Patobank and the information in the medical records on celiac disease-specific antibodies (ie, anti-tissue transglutaminase 2 IgA and IgG, endomysial antibodies IgA, and anti-deamidated gliadin peptide IgG) and HLA genotypes.
We identified 2,247 children who were registered in the Danish National Patient Register with celiac disease. Duodenal biopsies for 1,555 of the children (69%) were registered in the Patobank; 1,127 (50%) had a biopsy that was compatible with celiac disease (ie, Marsh 2-3). We accessed the medical records of 95% of the children who were registered in the Danish National Patient Register with celiac disease. We found that 1,510 (67%) had one or more positive antibody-test results; 1,120 (50%) had anti-tissue transglutaminase 2, IgA at tenfold or greater the upper limit of the normal range and/or positive endomysial antibody results. The positive predictive value depended on the criteria used for validation and the types and numbers of registrations that were included in the analysis and ranged from 62% (95% confidence interval: 60%-64%) to 86% (95% confidence interval: 84%-87%).
Our findings indicate that the Danish National Patient Register is a valuable source to identify patients who have been diagnosed with celiac disease. However, validation of the diagnoses is warranted before data on the patients are used for research purposes.
本研究的目的是验证丹麦国家患者登记册中记录的乳糜泻诊断。为了验证这些诊断，我们使用了来自国家病理报告登记册（病理库）的十二指肠活检信息，以及从患者病历中获取的乳糜泻特异性抗体和人类白细胞抗原（HLA）基因型信息。
我们纳入了所有1995年至2012年出生且在丹麦国家患者登记册中登记为患有乳糜泻的儿童。我们查阅了病理库中所有关于十二指肠活检的病理报告，以及病历中关于乳糜泻特异性抗体（即抗组织转谷氨酰胺酶2 IgA和IgG、肌内膜抗体IgA以及抗脱酰胺麦醇溶蛋白肽IgG）和HLA基因型的信息。
我们确定了2247名在丹麦国家患者登记册中登记患有乳糜泻的儿童。其中1555名儿童（69%）的十二指肠活检记录在病理库中；1127名（50%）的活检结果与乳糜泻相符（即马什2 - 3级）。我们查阅了95%在丹麦国家患者登记册中登记患有乳糜泻的儿童的病历。我们发现，1510名（67%）有一项或多项抗体检测结果呈阳性；1120名（50%）的抗组织转谷氨酰胺酶2 IgA水平为正常范围上限的十倍或更高，和/或肌内膜抗体检测结果呈阳性。阳性预测值取决于用于验证的标准以及分析中纳入的登记类型和数量，范围从62%（95%置信区间：60% - 64%）到86%（95%置信区间：84% - 87%）。
我们的研究结果表明，丹麦国家患者登记册是识别已被诊断患有乳糜泻患者的宝贵来源。然而，在将患者数据用于研究目的之前，有必要对诊断进行验证。
