CDER/OSE/DEPI I, US Food and Drug Administration, Silver Spring, MD, USA.
Pharmacoepidemiol Drug Saf. 2013 Nov;22(11):1233-8. doi: 10.1002/pds.3511. Epub 2013 Sep 3.
The purposes of this study were to determine (i) the positive predictive value (PPV) of multiple Read codes used to identify congenital cardiac malformation (CCM) cases in the UK Clinical Practice Research Datalink (CPRD); (ii) the accuracy of the diagnosis date; and (iii) the source of information that the general practitioners (GPs) use for validating the diagnosis suggested by the code.
Eight hundred eighty-eight records with Read diagnostic and procedures codes for CCM, between January 1996 and November 2010, were identified from CPRD. Questionnaires were sent to GPs to verify the diagnoses and date of the code-identified events.
A total of 719 questionnaires were returned (81% response rate). The PPV of the CCM codes was 93% (670/719). Thirty-one percent of cases had a different event date than the one recorded in the electronic medical record (EMR); 10% of these differing dates were within 30 days of the code-identified CCM date. GPs used a variety of data sources to confirm CCM diagnoses. Although the EMR was the most frequently used data source (70%), 66% reported using consultation letters, 9% reported using clinical notes or paper charts, and 35% of GPs reported using the hospital record to confirm the CCM diagnosis.
Clinical Practice Research Datalink Read codes for CCMs have 93% PPV and most likely point to true cases. However, the accuracy of diagnosis dates and the age at diagnosis may not be as reliable. The findings of this study indicate that GPs use information beyond what is available for researchers in the EMR to confirm clinical diagnoses when responding to validation questionnaires. Published 2013. This article is a U.S. Government work and is in the public domain in the USA.
本研究旨在确定：(i) 英国临床实践研究数据库（CPRD）中用于识别先天性心脏畸形（CCM）病例的多个 Read 编码的阳性预测值（PPV）；(ii) 诊断日期的准确性；以及 (iii) 全科医生（GP）用于验证代码提示的诊断的信息来源。
从 CPRD 中确定了 1996 年 1 月至 2010 年 11 月期间记录的 888 例与 CCM 相关的 Read 诊断和程序编码的记录。向 GP 发送了调查问卷以验证诊断和代码识别事件的日期。
共收回 719 份问卷（81%的回应率）。CCM 代码的 PPV 为 93%（670/719）。31%的病例的事件日期与电子病历（EMR）中记录的日期不同；其中 10%的差异日期在代码识别的 CCM 日期的 30 天内。GP 使用各种数据源来确认 CCM 诊断。尽管 EMR 是最常使用的数据源（70%），但 66%的 GP 报告使用了咨询信，9%的 GP 报告使用了临床记录或纸质图表，35%的 GP 报告使用了医院记录来确认 CCM 诊断。
CPRD Read 编码的 CCM 有 93%的 PPV，很可能指向真实病例。然而，诊断日期和诊断时的年龄的准确性可能并不那么可靠。本研究的结果表明，GP 在回应验证问卷时，会使用 EMR 中可用于研究人员的信息之外的信息来确认临床诊断。2013 年出版。本文为美国政府的工作成果，在美国属于公有领域。
