Centre for Innovation in Complex Care , University Health Network.
Appl Clin Inform. 2011 Nov 16;2(4):472-80. doi: 10.4338/ACI-2011-04-CR-0026. Print 2011.
Clinical trials are widely accepted as a necessary step in evaluating the safety and efficacy of new pharmaceutical products. In order for a sufficiently powered study, a clinical trial depends on the effective and unbiased recruitment of eligible patients. Trials involving seasonal diseases like influenza pose additional challenges.
This is a feasibility study of a mobile real-time alerting system to systematically identify potential study subjects for a randomized controlled trial evaluating the safety and efficacy of early intervention with interferon alfacon-1 for patients hospitalized for influenza virus infection.
The alerting system was setup in a 471-bed acute care teaching hospital, enabled with computerized physician order entry (CPOE) and a rules-based alerting system. Patients were identified from the entire hospital using two alerts types: pharmacy prescription records for antiviral drugs, and positive influenza laboratory results. Email alerts were generated and sent to BlackBerry(®) devices carried by the study personnel for a 6 month period. The alerts were archived automatically on a secure server and were exported for analysis in Microsoft Access.
Over a period of 21 weeks, 779 total alerts were received. The study team was alerted to 241 patients, of whom 85 were potential study subjects. The alert system identified all but one of the patients independently identified by infection control.
Real-time identification of potential study subjects is possible with the integration of computerized physician order entry and BlackBerry(®) technology. It is a viable method for the systematic identification of patients throughout a hospital, particularly for trials investigating time-sensitive disease progression.
临床试验被广泛认为是评估新药物产品安全性和疗效的必要步骤。为了进行一项充分有力的研究，临床试验依赖于对合格患者进行有效和无偏的招募。涉及流感等季节性疾病的试验带来了额外的挑战。
本研究旨在评估一种移动实时警报系统用于系统性识别潜在研究对象的可行性，该系统将用于评估干扰素 alfacon-1 早期干预对因流感病毒感染住院患者的安全性和疗效的随机对照试验。
该警报系统设置在一家拥有计算机化医嘱录入系统（CPOE）和基于规则的警报系统的 471 张病床的急性护理教学医院。使用两种警报类型从整个医院识别患者：抗病毒药物的药房处方记录和阳性流感实验室结果。在 6 个月的时间内，为携带研究人员 BlackBerry(®)设备生成并发送电子邮件警报。警报将自动存档在安全服务器上，并在 Microsoft Access 中导出进行分析。
在 21 周的时间内，共收到 779 条总警报。研究小组共向 241 名患者发出警报，其中 85 名是潜在的研究对象。该警报系统除了感染控制人员独立识别的一名患者外，还识别出了所有其他患者。
通过将计算机化医嘱录入系统和 BlackBerry(®)技术集成，可以实时识别潜在的研究对象。这是一种在整个医院系统地识别患者的可行方法，特别是对于调查时间敏感疾病进展的试验。
