Implementing single source: The STARBRITE proof-of-concept study
Implementing single source: The STARBRITE proof-of-concept study
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DOI：
10.1197/jamia.m2157
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发表时间：
2007-09-01
影响因子：
6.4
通讯作者：
Nahm, Meredith
中科院分区：
文献类型：
--
作者：
Kush, Rebecca;Alschuler, Liora;Nahm, Meredith
目的：临床试验数据收集效率低下导致延误，增加成本，并可能减少临床医生参与医学研究。在这项概念验证研究中，我们研究了在工作临床试验的背景下，在医疗记录和临床研究中使用即时护理数据捕获的可行性。我们假设，通过这样做，我们可以增加患者数据的重用，消除冗余的数据输入，并最大限度地减少对临床工作流程的干扰。设计：我们开发并使用了一个即时护理电子数据采集系统来记录患者就诊期间的数据。基于标准的系统用于临床研究和生成医疗记录的临床笔记。该系统与正在进行的多中心临床试验的数据收集程序并行工作。我们的系统是在分析病例报告表格和临床记录，观察临床工作流程模式和业务流程的基础上迭代设计的。使用来自CDISC和HL7的现有数据标准进行数据库插入和临床文献交换。结果：我们的系统成功地集成到临床环境中，并在两个实时测试用例中使用，而没有中断现有的工作流程。在系统设计期间执行的分析产生了影响自动提取、存储和重用医疗保健数据的系统实现的实际问题的详细信息。结论：尽管受到小型可行性研究的限制，我们的研究表明，电子患者数据可以重复用于前瞻性的多中心临床研究和患者护理，并表明需要进一步制定治疗领域标准，以促进研究人员使用医疗保健数据。
Objective: Inefficiencies in clinical trial data collection cause delays, increase costs, and may reduce clinician participation in medical research. In this proof-of-concept study, we examine the feasibility of using point-of-care data capture for both the medical record and clinical research in the setting of a working clinical trial. We hypothesized that by doing so, we could increase reuse of patient data, eliminate redundant data entry, and minimize disruption to clinic workflow.Design: We developed and used a point-of-care electronic data capture system to record data during patient visits. The standards-based system was used for clinical research and to generate the clinic note for the medical record. The system worked in parallel with data collection procedures already in place for an ongoing multicenter clinical trial. Our system was iteratively designed after analyzing case report forms and clinic notes, and observing clinic workflow patterns and business procedures. Existing data standards from CDISC and HL7 were used for database insertion and clinical document exchange.Results: Our system was successfully integrated into the clinic environment and used in two live test cases without disrupting existing workflow. Analyses performed during system design yielded detailed information on practical issues affecting implementation of systems that automatically extract, store, and reuse healthcare data.Conclusion: Although subject to the limitations of a small feasibility study, our study demonstrates that electronic patient data can be reused for prospective multicenter clinical research and patient care, and demonstrates a need for further development of therapeutic area standards that can facilitate researcher use of healthcare data.