Hammad Tarek A, McAdams Mara A, Feight Andrea, Iyasu Solomon, Dal Pan Gerald J
Office of Surveillance and Epidemiology, Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20993-0002, USA.
Pharmacoepidemiol Drug Saf. 2008 Dec;17(12):1197-201. doi: 10.1002/pds.1672.
To determine (1) the positive predictive value (PPV) of multiple Read/OXMIS codes to identify incident acute myocardial infarction (AMI) cases in General Practice Research Database (GPRD); (2) the ability to capture the correct timing of the clinical event.
A random sample of 238 records (from 155 general practitioner (GP) practices) with AMI codes, between 1 January 1997 and 31 December 2004, was selected from GPRD. Questionnaires were sent to the GPs to verify the diagnosis and timing of code-identified incident AMI events and collect supporting information. We calculated the PPV of the AMI codes as the proportion of code-identified AMIs that the GPs confirmed as AMI cases. Two physicians from Food and Drug administration (FDA), blinded to the GP response, reviewed the supporting hospital records returned by GPs for 98 AMI cases.
A total of 217 questionnaires were completed (91% response rate). The PPV of the AMI codes was 93% (201/217). Thirty one (15%) cases had a different event date than the one recorded in the electronic medical records (EMR); 28 (90%) of the dates were within 15 days. One GP indicated that a patient had a previous AMI, 110 days before the codes that captured the AMI diagnosis. A total of 159 (79%) AMI cases were hospitalized; hospital records were provided for 98 patients. Physician review of the hospital records found that 96% of these records had enough information for classification, but not independent diagnosis, of AMI.
Information in GPRD is sufficient to identify incident AMI cases and determine the event date with reasonable accuracy.
确定(1)多个Read/OXMIS编码在全科医学研究数据库(GPRD)中识别新发急性心肌梗死(AMI)病例的阳性预测值(PPV);(2)捕捉临床事件正确时间的能力。
从GPRD中选取1997年1月1日至2004年12月31日期间有AMI编码的238份记录(来自155个全科医生(GP)诊所)的随机样本。向全科医生发送问卷,以核实编码识别的新发AMI事件的诊断和时间,并收集支持性信息。我们将AMI编码的PPV计算为全科医生确认为AMI病例的编码识别的AMI病例所占比例。两名来自食品药品监督管理局(FDA)的医生在不知道全科医生回复的情况下,审查了全科医生返回的98例AMI病例的支持性医院记录。
共完成217份问卷(回复率91%)。AMI编码的PPV为93%(201/217)。31例(15%)病例的事件日期与电子病历(EMR)中记录的日期不同;其中28例(90%)的日期在15天内。一名全科医生指出,一名患者在捕捉到AMI诊断的编码前110天曾发生过AMI。共有159例(79%)AMI病例住院治疗;提供了98名患者的医院记录。医生对医院记录的审查发现,其中96%的记录有足够信息用于AMI的分类,但不能独立诊断。
GPRD中的信息足以识别新发AMI病例并以合理的准确性确定事件日期。