在非药物,非手术试验中干预忠实性的指导:一个范围审查
Fernando Sousa1, Mengda Zhu1, Melanie K Farlie1
1School of Primary and Allied Health Care, Monash University, Melbourne, Australia.
Journal of clinical epidemiology
|June 15, 2025
概括
需要改进对试验中的干预忠实性的报告. 这一审查发现现有的指南缺乏明确的方法和共识,强调需要标准化报告指南,以确保研究中的干预准确性.
科学领域:
- 医疗保健服务研究 医疗服务研究
- 临床试验方法论 临床试验方法论
- 干预科学 干预科学
背景情况:
- 干预忠实性对于评估非药物,非手术干预的有效性至关重要.
- 试验中对干预准确性的报告不足,妨碍了结果的可复制性和解释性.
- 关于干预忠实性的现有指导文件缺乏标准化和清晰度.
研究的目的:
- 系统地审查干预忠实性指导文件.
- 评估这些指导文件的开发方法.
- 综合术语,定义,领域,并为干预忠实性的建议.
主要方法:
- 搜索了6个数据库并进行引用搜索以确定相关文件.
- 在选了7000多份记录后,包括了73份文件.
- 进行定性内容分析以提取和合成数据.
主要成果:
- 大多数文件 (92%) 没有明确报告开发方法;只有1%使用共识.
- 在干预忠实性定义 (6类) 和域名 (7类) 上发现了有限的共识.
- 在50%以上的文件中只报告了2个领域,很少有建议被广泛采用.
结论:
- 现有的干预忠实指导反映了不断变化的领域,需要更大的共识.
- 差距和不一致性需要更清晰,更系统,更适用于全球的指南.
- 调查结果将为ReFiND的发展提供信息,ReFiND是干预忠实性的国际报告准则.
相关概念视频
01:23Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches
184
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,...
184
01:29Nursing Interventions II: Selecting and Classifying the Nursing Interventions
2.4K
Creating and executing a nursing diagnosis helps nurses plan care and guide patient, family, and community interventions. They are developed based on a patient's physical evaluation and support measuring the outcomes. It is not recommended to select random interventions throughout the planning process. Instead, consider the following six essential factors when choosing interventions:
2.4K
01:11Clinical Trials: Overview
3.4K
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...
3.4K
01:16Clinical Trials
9.3K
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...
9.3K
02:07Blind Procedures
12.2K
Ideally, the people who observe and record the children’s behavior are unaware of who was assigned to the experimental or control group, in order to control for experimenter bias. Experimenter bias refers to the possibility that a researcher’s expectations might skew the results of the study. Remember, conducting an experiment requires a lot of planning, and the people involved in the research project have a vested interest in supporting their hypotheses. If the observers knew which...
12.2K
01:11Blinding
3.2K
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.
3.2K