改善对服务不足的群体在试验中的纳入:开发和实施INCLUDE受损能力同意框架
Victoria Shepherd1, Katherine Joyce2, Amanda Lewis2
1Centre for Trials Research, Cardiff University, 4th floor Neuadd Meirionnydd, Heath Park, Cardiff, CF14 4YS, UK. ShepherdVL1@cardiff.ac.uk.
Trials
|January 25, 2024
概括
"INCLUDE同意能力受损框架"有助于研究人员将缺乏能力的成年人纳入临床试验. 这一框架和工具包旨在改善试验设计和参与者多样性,以改善健康公平.
科学领域:
- 临床试验的设计
- 卫生公平性健康公平性
- 研究伦理研究伦理学
背景情况:
- 同意能力受损的成年人经常被排除在临床试验之外.
- 研究人员需要关于包容性试验设计的法律,伦理和方法方面的指导.
- "NIHR INCLUDE"倡议为制定这一框架提供了基础.
研究的目的:
- 开发INCLUDE同意能力受损框架,以帮助研究人员设计包容性试验.
- 提供实用资源和指导,以纳入有能力受损的参与者.
主要方法:
- 采用了五个阶段的开发过程.
- 这包括调整现有框架,试点,咨询利益相关者,改进内容,并创建实施工具包.
- "INCLUDE民族框架"是为这个特定的人群而改编的.
主要成果:
- 该框架包括关键问题和工作表,用于试验设计,招聘,同意,数据收集和传播.
- 一个实现工具包与资源,如信息图表,动画和研讨会支持研究人员.
- 启动活动显示,利益相关者对框架和工具包的认识增加和积极接收.
结论:
- 该框架和工具包为设计涉及能力受损成年人的更具包容性的研究研究提供支持.
- 建议与资助者进一步接触,并进行持续评估,以确保广泛采用和影响.
相关概念视频
01:27Nurses' Legal Responsibilities I
745
In healthcare, informed consent is a crucial process that involves thoroughly communicating medical treatment options to patients, including benefits, risks, potential side effects, and alternatives. This process enables patients to make well-informed decisions about their care, ensuring they understand the implications of their choices before consenting to or refusing treatment.
The legal responsibilities of a nurse regarding informed consent include the following:
The legal responsibilities of a nurse regarding informed consent include the following:
745
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
01:11Clinical 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
01:56Ethics in Research
23.0K
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.
23.0K
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
01:30Community Based Intervention
43
Community-based interventions in mental health represent a paradigm shift from institution-centered care to treatments embedded within the fabric of local communities. By prioritizing inclusion and leveraging existing societal structures, this approach fosters a supportive environment conducive to addressing mental health challenges while promoting individual dignity and agency.
Foundations of Community Mental Health Programs
Central to the success of community-based interventions is the...
Foundations of Community Mental Health Programs
Central to the success of community-based interventions is the...
43