癌症临床试验中的不良事件报告:纳入患者报告的方法. 一个系统的范围审查
Minna Grahvendy1,2, Bena Brown3,4, Laurelie R Wishart5,6,7
1Cancer Trials Unit, Princess Alexandra Hospital, Queensland Health, Brisbane, QLD, 4102, Australia. minna.grahvendy@health.qld.gov.au.
The patient
|April 8, 2024
概括
患者报告的不良事件在临床试验中越来越重要,但它们的收集和报告仍然不一致. 需要标准化,专门构建的工具来提高数据质量和以参与者为中心的护理.
科学领域:
- 临床研究方法论临床研究方法论
- 患者安全和结果.
- 医疗信息学 医疗信息学
背景情况:
- 从历史上看,临床试验依赖于研究人员报告的安全数据,自1945年以来,像共同术语对不良事件标准 (CTCAE) 这样的框架一直在发展.
- 转向以患者为中心的护理,增加了人们对直接从参与者那里收集不良事件数据 (患者报告的不良事件) 的兴趣.
研究的目的:
- 系统地包括患者报告的不良事件数据在安全性和耐受性分析中的范围.
- 探索在临床研究中收集和报告患者报告的不良事件数据的当前做法.
主要方法:
- 进行了系统的范围审查,通过Covidence平台管理结果.
- 用描述性分析来检查68项纳入研究的数据.
主要成果:
- 随着时间的推移,结合患者报告的不良事件数据的研究数量有所增加.
- 采用了70种不同的仪器来收集数据,回忆时间,模式,频率和注射地点的变化很大.
- 关于数据收集方法的细节经常被遗漏在出版物中,研究经常使用多个仪器 (1-7).
结论:
- 尽管越来越多的倡导,患者报告的不良事件的整合到公布的安全性分析仍然有限.
- 目前收集和报告患者报告的不良事件的方法不一致,并且经常使用非专用制造的仪器.
- 通过经过验证的,专门构建的仪器进行标准化对于解决患者报告的不良事件数据的变异性和提高不良事件数据的质量至关重要.
相关概念视频
01:21Cancer Survival Analysis
345
Cancer survival analysis focuses on quantifying and interpreting the time from a key starting point, such as diagnosis or the initiation of treatment, to a specific endpoint, such as remission or death. This analysis provides critical insights into treatment effectiveness and factors that influence patient outcomes, helping to shape clinical decisions and guide prognostic evaluations. A cornerstone of oncology research, survival analysis tackles the challenges of skewed, non-normally...
345
01:12Hazard Ratio
116
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...
116
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
01:26Types of Reports III: Telephone and Verbal Reports
738
Telephone and Verbal Reports in healthcare settings are two communication methods for conveying therapeutic instructions from healthcare providers to nurses or other healthcare staff.
Here's an overview of each type:
Telephone Orders
Here's an overview of each type:
Telephone Orders
738
01:24Kaplan-Meier Approach
135
The Kaplan-Meier estimator is a non-parametric method used to estimate the survival function from time-to-event data. In medical research, it is frequently employed to measure the proportion of patients surviving for a certain period after treatment. This estimator is fundamental in analyzing time-to-event data, making it indispensable in clinical trials, epidemiological studies, and reliability engineering. By estimating survival probabilities, researchers can evaluate treatment effectiveness,...
135
01:11Clinical Trials: Overview
2.9K
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...
2.9K