在口服HIV临床研究中实施REDCap移动应用程序
Ana Lucia Seminario1,2, Ashley E Karczewski3, Sara Stanley3
1Timothy A. DeRouen Center for Global Oral Health, University of Washington School of Dentistry, 1959 NE Pacific St B-307, Seattle, WA, 98115, USA. alsadem@uw.edu.
BMC public health
|February 27, 2024
概括
这项研究使用REDCap移动应用程序实施了电子数据收集系统,以研究秘鲁与艾滋病毒感染者发生性关系的男性的酒精使用障碍和口腔健康. 该应用程序促进了有效的数据捕获,支持未来对这个脆弱人群的研究.
科学领域:
- 公共卫生 公共卫生
- 临床研究信息学 临床研究信息学
- 艾滋病毒/艾滋病研究研究
背景情况:
- 秘鲁的艾滋病毒病例集中在与男性发生性关系的男性 (MSM) 中.
- 艾滋病毒感染者 (PWH) 患口腔疾病的比率更高,即使接受治疗.
- 酒精使用障碍 (AUD) 在PWH中很普遍,需要进一步调查其与口腔健康的交叉关系.
研究的目的:
- 为了产生关于AUD与秘鲁艾滋病毒感染的MSM口腔健康之间的关联的基础证据.
- 增强对AUD,口腔健康和艾滋病毒的未来研究的研究能力.
- 在低中等收入国家 (LMIC) 环境中使用REDCap移动应用程序实施现场电子数据收集系统.
主要方法:
- 使用了五项经过验证的调查,包括人口统计,病史,艾滋病毒状况,酒精使用,耻辱感,口腔健康和补充剂使用.
- 在秘鲁利马的两家艾滋病毒诊所,通过iPad上的REDCap移动应用程序进行调查.
- 校准了应用程序和数据收集协议,并对参与者和员工进行了反,以提高效率和体验.
主要成果:
- 收集了398名参与者的数据 (平均年龄35.94±9.13岁),其中98.5%的参与者是男性,85.7%的参与者是同性恋者.
- 确定了高风险饮酒的流行率:78.1%的人饮酒过度,12.3%的人是重饮者.
- 通过REDCap应用程序成功替换纸质记录,在对效率和流量进行修改后,直接将数据存储在REDCap数据库中.
结论:
- 在这个LMIC环境中,REDCap移动应用程序在数据收集方面被证明是有效的.
- 主要应用程序功能包括离线数据捕获,多语言翻译和用户友好的界面.
- 该系统的低成本和广泛的支持进一步有助于其成功部署.
相关概念视频
Clinical Trials
8.5K
Clinical trials are prospective experimental studies conducted on humans to determine the safety and efficacy of treatments, drugs, diet methods, and medical devices. Using statistics in clinical trials enables researchers to derive reasonable and accurate conclusions from the collected data, allowing them to make wise decisions in uncertain situations. In medical research, statistical methods are crucial for preventing errors and bias.
There are four phases in a clinical trial. A phase one...
There are four phases in a clinical trial. A phase one...
8.5K
Clinical Trials: Overview
4.7K
Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
4.7K
Bioavailability Study Design: Healthy Subjects Versus Patients
248
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,...
248


