一个案例报告使用基于实验室的决策支持警报用于研究招募和随机化
April Barnado1,2, Ryan P Moore3, Henry J Domenico3
1Division of Rheumatology and Immunology, Department of Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, United States.
Applied clinical informatics
|October 24, 2025
概括
针对涉及抗核抗体 (ANA) 阳性个体的实用研究,实施定制的临床决策支持 (CDS) 警报面临技术障碍. 与实验室团队的密切合作对于成功执行警报至关重要.
科学领域:
- 临床信息学 临床信息学
- 类风湿病学 类风湿病学
- 医疗保健服务研究 医疗服务研究
背景情况:
- 阳性抗核抗体 (ANA) 测试是常见的,但并不总是表明自身免疫性疾病.
- 预测模型可以识别患有自身免疫疾病风险较高的个体.
- 实用研究需要有效的方法来随机参与者在电子健康记录.
研究的目的:
- 在实用性研究中识别实施定制临床决策支持 (CDS) 警报的障碍,用于参与者随机化.
- 评估使用CDS警报的可行性,该警报由积极的ANA测试引发,用于预测自身免疫性疾病风险和早期转诊.
主要方法:
- 将一个验证的后勤回归模型集成到电子健康记录 (EHR) 中,以预测ANA阳性个体的自身免疫疾病风险 (定量≥1:80).
- 开发了一个无声的,定制的CDS警报,以随机选择符合条件的个人进入实用研究.
- 随机选择的参与者分为干预组 (风险评分审查,提供者通知,加快转诊) 和对照组 (标准护理).
主要成果:
- 自2023年6月以来,成功评估了3,961人,并随机选择了2,105人.
- 遇到的技术挑战包括实验室供应商的变化,设备故障和改变的测试名称,这影响了CDS警报功能.
- 证明了基于实验室的CDS警报的可行性,用于在大型医疗保健系统的随机化.
结论:
- 基于实验室的定制CDS警报可以在大型医疗保健系统中的实用研究中促进参与者随机化.
- 与实验室团队的密切合作和对实验室测试工作流程的深入理解对于成功实施CDS警报至关重要.
- 积极应对技术挑战是确保CDS警报在研究环境中持续运行的关键.
更多相关视频
04:53A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition
Published on: September 20, 2019
11.1K
07:31Implementation of a Real-Time Psychosis Risk Detection and Alerting System Based on Electronic Health Records using CogStack
Published on: May 15, 2020
7.5K
相关概念视频
01:13Randomized Experiments
8.8K
The randomization process involves assigning study participants randomly to experimental or control groups based on their probability of being equally assigned. Randomization is meant to eliminate selection bias and balance known and unknown confounding factors so that the control group is similar to the treatment group as much as possible. A computer program and a random number generator can be used to assign participants to groups in a way that minimizes bias.
Simple randomization
Simple...
Simple randomization
Simple...
8.8K
01:11Blinding
3.8K
Blinding is a commonly used method of not telling participants which treatment a subject is receiving. Blinding is a critical part of a randomized control trial or RCT. It reduces the bias that affects the results. In an RCT, blinding is used in the form of a placebo. A placebo effect occurs when untreated subjects falsely believe they have received the treatment and report improved symptoms. A placebo or a dummy treatment is administered to subjects to negate the bias caused by such an effect.
3.8K
01:23Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches
404
Biopharmaceutical studies constitute a vital field aiming to enhance drug delivery methods and refine therapeutic approaches, drawing upon diverse interdisciplinary knowledge. In research methodologies, the choice between controlled and non-controlled studies significantly influences the study's reliability and accuracy.
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...
404
02:07Blind Procedures
12.8K
Ideally, the people who observe and record the children’s behavior are unaware of who was assigned to the experimental or control group, in order to control for experimenter bias. Experimenter bias refers to the possibility that a researcher’s expectations might skew the results of the study. Remember, conducting an experiment requires a lot of planning, and the people involved in the research project have a vested interest in supporting their hypotheses. If the observers knew which...
12.8K
01:56Ethics in Research
25.4K
Today, scientists agree that good research is ethical in nature and is guided by a basic respect for human dignity and safety. However, this has not always been the case. Modern researchers must demonstrate that the research they perform is ethically sound.
25.4K
01:15Bioavailability Study Design: Healthy Subjects Versus Patients
143
Bioavailability studies are essential for evaluating a drug's therapeutic efficacy and understanding its absorption patterns under various physiological conditions. Conducting such studies on target patient populations provides more relevant data by simulating real-world disease states. However, practical challenges often necessitate the use of young, healthy adult volunteers as study subjects.Patients may exhibit altered drug absorption patterns due to the effects of the disease itself,...
143