Electronic Support for Public Health - Vaccine Adverse Event Reporting System (ES

公共卫生电子支持 - 疫苗不良事件报告系统 (ES

• 批准号: 7499529
• 负责人: ROSS LAZARUS
• 金额: $ 49.94万
• 依托单位: HARVARD PILGRIM HEALTH CARE, INC.
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-09-30 至 2010-09-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7499529
• 关键词: Electronic; Support; Public; Health; Vaccine

DESCRIPTION (provided by the applicant): Routine vaccination has dramatically decreased the incidence of many serious diseases, and new vaccines are becoming available to improve the quality of health care. Vaccination programs are a cornerstone of modern public health, and are of central importance in preparedness for dealing with potential health emergencies, such as the recurrence of pandemic influenza. Public and professional confidence in vaccination depends on reliable post-marketing surveillance systems to ensure that rare and unexpected adverse effects are rapidly identified. Our goal is to improve the quality of vaccination programs by improving the quality of physician adverse vaccine event detection and reporting to the national Vaccine Adverse Event Reporting System (VAERS). Electronic medical records available from all ambulatory care encounters in a large multi-specialty practice will be used. Every patient receiving a vaccine will be automatically identified, and for the next 30 days their health care diagnostic codes, laboratory tests, and medication prescriptions will be evaluated for values suggestive of an adverse event. When a possible adverse event is detected it will be recorded, and the appropriate clinician will be notified electronically. Clinicians will be able to preview a pre-populated report with information from the electronic medical record about the patient, including vaccine type, lot number, and possible adverse effect, to inform their clinical judgment about whether they wish to send a report. Clinicians will have the option of adding free-text comments to pre-populated VAERS reports or to document their decision not to send a report. Approved reports will be securely transferred to VAERS as electronic messages in an interoperable health data exchange format (HL7). We will evaluate the system by comparing adverse event findings to those in the Vaccine Safety Datalink project and in a randomized trial to test the hypothesis that the combination of secure, computer-assisted, clinician approved, adverse event detection and automated electronic reporting will substantially increase the number, completeness, validity and timeliness of physician approved case reports to VAERS compared to the existing spontaneous reporting system.

描述（由申请人提供）：常规疫苗接种大大降低了许多严重疾病的发病率，新的疫苗正在出现，以提高卫生保健的质量。疫苗接种规划是现代公共卫生的基石，对应对大流行性流感复发等潜在突发卫生事件的准备工作至关重要。公众和专业人员对疫苗接种的信心取决于可靠的上市后监测系统，以确保迅速发现罕见和意外的不良反应。我们的目标是通过提高医生不良疫苗事件检测和向国家疫苗不良事件报告系统（VAERS）报告的质量来提高疫苗接种计划的质量。电子医疗记录可从所有流动护理遭遇在一个大型的多专业实践将被使用。每个接种疫苗的患者都将被自动识别，在接下来的30天内，他们的医疗诊断代码、实验室测试和药物处方将被评估为提示不良事件的值。当检测到可能的不良事件时，将记录下来，并以电子方式通知相应的临床医生。临床医生将能够预览预先填充的报告，其中包含来自患者电子病历的信息，包括疫苗类型、批号和可能的不良反应，以告知他们是否希望发送报告的临床判断。临床医生可以选择在预先填写的VAERS报告中添加自由文本评论，或者记录他们不发送报告的决定。批准的报告将以可互操作的健康数据交换格式（HL7）作为电子消息安全地传输到VAERS。我们将通过将不良事件发现与疫苗安全数据链项目和随机试验中的结果进行比较来评估该系统，以验证与现有的自发报告系统相比，安全、计算机辅助、临床医生批准、不良事件检测和自动电子报告的组合将大大增加医生批准的病例报告给VAERS的数量、完整性、有效性和及时性。