Routine data from hospital information systems can support patient recruitment for clinical studies
Routine data from hospital information systems can support patient recruitment for clinical studies
复制标题
DOI：
10.1177/1740774510363013
复制
发表时间：
2010-04-01
期刊：
影响因子：
2.7
通讯作者：
Prokosch, Hans-Ulrich
中科院分区：
文献类型：
--
作者：
Dugas, Martin;Lange, Matthias;Prokosch, Hans-Ulrich
背景 患者招募延迟是临床研究中的一个常见问题。医院信息系统 (HIS) 包含与这些研究的纳入或排除标准相关的数据项。目的我们开发并评估了一个系统，以支持使用 HIS 数据招募患者。方法我们开发了一个集成在 HIS 中的工作流程，以通知研究医生有关潜在试验受试者的信息。根据每个临床研究的纳入和排除标准定期执行自动 HIS 数据库查询，并通过通信服务器生成电子邮件通知。研究医生可以使用特定的 HIS 研究模块来验证资格。通过针对效用、可用性、稳定性、招募率变化和估计时间节省的调查来评估系统性能。结果 在 10 个月的运行期间，生成了 1328 条通知，并记录了 7 项研究的 329 名注册者 (25%)。警报的精确度取决于适当的 HIS 项目的可用性。实用性和可用性被评估为良好，稳定性为优秀。用户报告三项研究的患者招募率有所增加。三项研究报告称，每位招募的患者预计可节省 10 分钟的时间。主要的感知好处是系统地识别潜在合格患者，无需在医院的不同部门进行耗时的患者筛查程序。 局限性 关于潜在合格患者的通知取决于有关纳入/排除标准的 HIS 数据质量，特别是完整性、及时性和有效性。结论 常规 HIS 数据可以通过自动通知工作流程和有效访问临床数据来支持临床研究的患者招募。临床试验2010； 7：183-189。 http://ctj.sagepub.com。
Background Delayed patient recruitment is a common problem in clinical studies. Hospital information systems (HIS) contain data items relevant for inclusion or exclusion criteria of these studies.Purpose We developed and assessed a system to support patient recruitment using HIS data.Methods We developed a workflow integrated in our HIS to notify study physicians about potential trial subjects. Automatic HIS database queries based on inclusion and exclusion criteria for each clinical study are performed regularly and generate e-mail notifications via a communication server. Study physicians can verify eligibility with a specific HIS study module. The system performance was assessed with a survey addressing utility, usability, stability, change in recruitment rate, and estimated time savings.Results During 10 months of operation, 1328 notifications were generated and 329 enrollments (25%) were documented for seven studies. Precision of alerts depends on availability of appropriate HIS items. Utility and usability were assessed as good, and stability as excellent. Users reported an increased patient recruitment rate for three studies. Three studies reported an estimated time saving of 10 min per recruited patient. The main perceived benefit was systematic identification of potentially eligible patients without time-consuming patient screening procedures in the different parts of the hospital.Limitations Notifications about potentially eligible patients depend on HIS data quality regarding inclusion/exclusion criteria, in particular, completeness, timeliness, and validity.Conclusions Routine HIS data can support patient recruitment for clinical studies by means of an automated notification workflow and efficient access to clinical data. Clinical Trials 2010; 7: 183-189. http://ctj.sagepub.com.