在临床试验中概念化,操作化和利用公平,多样性和包容性:一个范围审查
Shiva Raj Mishra1, Aidan C Tan2, Karen Waller2
1NHMRC Clinical Trials Centre, The University of Sydney, Sydney, Australia; Westmead Applied Research Centre, The University of Sydney, Sydney, Australia.
Journal of clinical epidemiology
|December 22, 2024
概括
临床研究中的公平,多样性和包容性 (EDI) 应用不一致. 虽然工具存在,但研究合作伙伴的采用程度有限,影响证据质量和概括性.
科学领域:
- 临床研究 临床研究
- 健康 公平 卫生 公平
- 基于证据的医学 基于证据的医学
背景情况:
- 公平,多样性和包容 (EDI) 对于高质量的临床研究证据至关重要.
- 目前在临床试验中对EDI原则的应用是不一致和不清楚的.
- 了解EDI的操作性对于使不同的人群受益至关重要.
研究的目的:
- 扩大EDI在临床试验和更广泛的临床研究中的应用范围.
- 确定EDI概念是如何被概念化,操作化和利用的.
- 评估主要研究伙伴对EDI的考虑.
主要方法:
- 在PubMed和谷歌学者 (2000-2023) 的文献评论.
- 包括关于EDI概念,工具,指标或框架的研究.
- 在互联网上搜索来自研究机构,资助者和出版商的EDI声明.
主要成果:
- 分析了75项研究和49个灰色文献记录.
- EDI 概念被视为相互连接和加强.
- 为EDI评估确定了12个框架和20个工具/指标,使用率有限.
- 在出版商,试验注册,资助者和期刊中发现了有限的EDI考虑;从道德委员会或数据存储库中没有任何考虑.
结论:
- 存在各种EDI工具和框架,每一个都有局限性.
- 研究合作伙伴缺乏更广泛地采用EDI.
- 未来的研究应该检查EDI对试验结果和概括性的影响.
相关概念视频
Clinical Trials
6.6K
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...
6.6K
Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches
120
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,...
120
Ethics in Research
22.9K
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.
22.9K
Blinding
2.4K
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.
2.4K
Ethical Issues
848
Nurses are essential in patient care, upholding the ethical principles of their profession and effectively navigating ethical dilemmas. Neglecting ethical issues can lead to inadequate patient care, compromised therapeutic relationships, and moral distress among healthcare workers.
Ethical Concerns in Healthcare:
Ethical Concerns in Healthcare:
848
Strategies for Assessing and Addressing Confounding
83
Confounding is a critical issue in epidemiological studies, often leading to misleading conclusions about associations between exposures and outcomes. It occurs when the relationship between the exposure and the outcome is mixed with the effects of other factors that influence the outcome. Given that, addressing confounding is of high importance for drawing accurate inferences in research.
Confounding can be addressed at both the design phase of a study and through analytical methods after data...
Confounding can be addressed at both the design phase of a study and through analytical methods after data...
83


