在RCT中使用医疗保健系统数据
Alice-Maria Toader1, Carrol L Gamble2, Susanna Dodd3
1MRC-NIHR Trials Methodology Research Partnership, Department of Health Data Science, University of Liverpool, Liverpool, UK. Sgatoade@liverpool.ac.uk.
Trials
|January 30, 2024
概括
医疗保健系统数据 (HSD) 在随机对照试验 (RCT) 中越来越多地使用,最近62%的研究计划使用它. 然而,HSD目前不足以收集患者报告的结果 (PRO).
科学领域:
- 临床试验方法论 临床试验方法论
- 医疗保健服务研究 医疗服务研究
- 在医疗保健中的数据科学.
背景情况:
- 医疗保健系统数据 (HSD) 通过减少试验特定数据收集需求,有可能提高随机对照试验 (RCT) 的效率.
- 预计HSD在临床试验中的利用将会增长,据估计,在2019年国家卫生研究院 (NIHR) 资助的试验中,约有47%计划将HSD整合到临床试验中.
- 本研究调查了在RCT中HSD使用的当前程度,性质和演变.
研究的目的:
- 确定2019年之后开始的RCT中HSD的当前利用情况.
- 分类HSD的来源和应用,包括将其作为主要和次要结果的唯一数据源.
- 确定用于与HSD一起收集患者报告结果 (PRO) 的方法.
主要方法:
- 确定了一组由NIHR资助的正在进行的RCT,并于2019年后开始.
- 数据提取侧重于HSD的来源和应用,包括其在结果确定中的作用.
- 系统地审查了与HSD一起收集PRO的方法.
主要成果:
- 在84个符合条件的RCT中,62%计划将HSD纳入,而94%打算收集PRO.
- 计划在54%的试验中使用HSD作为至少一个结果的唯一数据来源,特别是主要 (20%) 和次要 (40%) 结果.
- 国家卫生服务 (NHS) 数字是最常见的HSD来源 (79%),而各种方法 (面对面,在线,邮政,电话,应用程序) 用于PRO收集.
结论:
- 大约三分之二的检查RCT正在使用HSD,这表明趋势正在增长.
- 目前的HSD不足以在这个队列中收集患者报告的结果数据.
- 与早期研究的比较证实,计划纳入HSD的RCT增加了.
相关概念视频
01:16Clinical Trials
6.7K
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...
6.7K
01:23Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches
128
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,...
128
01:30Health Information Technology and Healthcare Information System
841
Health Information Technology (HIT)
Health Information Technology, commonly called HIT, integrates advanced information systems and technology in healthcare settings. Its primary functions include:
Health Information Technology, commonly called HIT, integrates advanced information systems and technology in healthcare settings. Its primary functions include:
841
01:12Hazard Ratio
124
The hazard ratio (HR) is a widely used measure in clinical trials to compare the risk of events, such as death or disease recurrence, between two groups over time. It reflects the ratio of hazard rates—the instantaneous risk of the event occurring—between a treatment group and a control group. This measure provides valuable insights into the relative effectiveness of a treatment by assessing how the risk of an event differs between the two groups.
For example, in a clinical trial...
For example, in a clinical trial...
124
01:11Blinding
2.5K
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.
2.5K
01:29Issues And Trends In Healthcare Delivery System
5.6K
The issues and trends in healthcare delivery are constantly changing. The COVID-19 pandemic is one recent issue that wreaked havoc on healthcare systems, causing a shortage of healthcare workers, high demand for medicines and supplies, and increased medical expenditure due to a lack of insurance. Other issues include rising healthcare costs and care fragmentation.
Cost Containment
Payment for healthcare services has historically promoted adoption of costly and often unnecessary or inefficient...
Cost Containment
Payment for healthcare services has historically promoted adoption of costly and often unnecessary or inefficient...
5.6K