Cea Soriano Lucía, Soriano-Gabarró Montse, García Rodríguez Luis A
Spanish Centre for Pharmacoepidemiologic Research (CEIFE), Madrid, Spain.
Global Epidemiology, Bayer Pharma AG, Berlin, Germany.
Pharmacoepidemiol Drug Saf. 2016 Apr;25(4):385-91. doi: 10.1002/pds.3877. Epub 2015 Oct 5.
To validate the recorded diagnoses of colorectal cancer (CRC) and identify false negatives in The Health Improvement Network (THIN) primary care database.
We conducted a validation study of incident CRC cases in THIN among patients aged 40-89 years from 2000-2011. CRC Read code entries (N = 3805) were verified by manual review of patients' electronic medical records (EMRs) including free-text comments. Incident CRC cases in THIN ascertained following manual review were validated against two data sources deemed gold standards: (i) questionnaires sent to primary care practitioners (PCPs; for a random sample of 100 potential CRC cases), and (ii) Hospital Episode Statistics (HES) among linked practices. False negatives in THIN were identified by searching for International Classification of Diseases-10 codes related to CRC in HES.
Of 3805 CRC cases identified in THIN via Read codes, 3033 patients (80.0%) were considered definite cases after manual review of EMRs. The positive predictive value (PPV) of CRC Read codes was 86.0% after removing patients identified from THIN via a Read code for 'fast track referral for suspected CRC'. The response rate from PCPs was 87.0% (n = 87), and the PPV of CRC in THIN was 100% based on PCP questionnaires. Using HES, the PPV for CRC in THIN was 97.9% (556/568), and false negative rate was 6.1% (36/592).
CRC diagnostic Read codes in THIN have a high PPV, which is increased further following manual review of free-text comments. The false negative rate of CRC diagnoses in THIN is low.
验证《健康改善网络》（THIN）初级保健数据库中记录的结直肠癌（CRC）诊断，并识别假阴性病例。
我们对2000年至2011年40至89岁患者中THIN的新发CRC病例进行了验证研究。通过人工查阅患者的电子病历（EMR），包括自由文本注释，对CRC读取代码条目（N = 3805）进行了核实。在人工查阅后确定的THIN中的新发CRC病例，对照两个被视为金标准的数据源进行了验证：（i）发送给初级保健医生（PCP；针对100例潜在CRC病例的随机样本）的问卷，以及（ii）关联医疗机构中的医院事件统计数据（HES）。通过在HES中搜索与CRC相关的国际疾病分类第10版代码，识别出THIN中的假阴性病例。
通过读取代码在THIN中识别出的3805例CRC病例中，在人工查阅EMR后，3033例患者（80.0%）被视为确诊病例。在剔除通过“疑似CRC快速转诊”读取代码从THIN中识别出的患者后，CRC读取代码的阳性预测值（PPV）为86.0%。PCP的回复率为87.0%（n = 87），基于PCP问卷，THIN中CRC的PPV为100%。使用HES，THIN中CRC的PPV为97.9%（556/568），假阴性率为6.1%（36/592）。
THIN中的CRC诊断读取代码具有较高的PPV，在人工查阅自由文本注释后进一步提高。THIN中CRC诊断的假阴性率较低。
