骨科临床试验在语言和文化上有多样性吗? 一个系统的审查
Kaitlyn R Julian1, Ashley Mulakaluri1, Nicole M Truong1
1Department of Orthopaedic Surgery, University of California - San Francisco, 1500 Owens St., San Francisco, CA 94158.
JBJS reviews
|July 18, 2024
概括
骨科临床试验很少报告参与者的人口统计数据,如语言,种族或种族. 这种代表性不足限制了研究结果对不同患者群体的概括性.
科学领域:
- 整形外科的研究.
- 临床试验方法论 临床试验方法论
- 卫生公平性健康公平性
背景情况:
- 在随机对照试验 (RCT) 中不同人群的代表性不足会影响研究的有效性.
- 确保临床研究的包容性对于公平的医疗保健结果至关重要.
研究的目的:
- 在骨科RCT中评估参与者的多样性 (语言,种族,种族).
- 评估在这些试验中使用翻译和文化调整的患者报告结果指标 (PROM).
主要方法:
- 在PubMed,科学网和Embase搜索了使用PROM (2012-2022) 的骨科RCT.
- 专注于报告参与者的人口统计数据和使用适应的PROM.
- 使用Jadad标准评估方法质量.
主要成果:
- 只有14%的RCT报告了参与者的语言,11%报告了种族/种族.
- 翻译PROM仅在7%的试验中报告;文化调整的PROM在2%.
- 多国性研究没有报告语言或PROM适应.
结论:
- 在骨科RCT中,参与者人口统计和PROM适应的不频繁报告限制了概括性.
- 建议对人口统计数据和PROM适应方法进行标准化报告.
- 促进包容性研究实践对于不同患者群体至关重要.
相关概念视频
Clinical 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
Clinical 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


