相关实验视频

Updated: Jul 3, 2025

E-Patient Counseling Trial E-PACO: Computer Based Education versus Nurse Counseling for Patients to Prepare for Colonoscopy

E-Patient Counseling Trial E-PACO: Computer Based Education versus Nurse Counseling for Patients to Prepare for Colonoscopy

Published on: August 1, 2019

在设计复杂健康干预的实用试验时定义常规护理比较者:方法论审查

Katrina M Turner¹, Alyson Huntley², Tom Yardley²

¹Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK. Katrina.turner@bristol.ac.uk.

|February 11, 2024

概括

在实用试验中决定通常的护理需要平衡试验目标,伦理和现实世界的适用性. 研究人员必须考虑背景,利益相关者和可行性,以便进行可靠,有效的比较.

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

背景情况:

实用性试验通常使用常规护理作为比较器,但其异质性带来了方法和伦理方面的挑战.
标准化常规护理可能会提高严格性,但可能会损害外部有效性.
目前缺乏关于定义通常护理比较者的指导.

研究的目的:

在实用试验中,回顾当前有关常规护理比较者的内容的因素的思考.
为设计常规护理试验的研究人员提供框架.

主要方法:

进行了一项方法审查,搜索了MEDLINE,Embase,CINAHL和PsycINFO.
包括文章和书章,讨论常规护理比较器的发展,并补充了专家咨询.
数据使用叙事方法进行了合成.

主要成果:

试验目标,现有实践,临床指导方针和人口特征应为常规护理内容提供信息.
参与者保护的试验要求,实践的相关性,方法的稳定性,效率,可行性和利益相关者的接受度是关键驱动因素.
研究人员必须收集信息,平衡竞争目标,并确定常规护理的监测策略.

结论:

定义通常的护理比较器是一个复杂的,取决于背景的决定,需要权衡.
了解试验背景和目标对于伦理和科学合理的比较至关重要.
在试验设计过程中,需要足够的时间,资金,利益相关者参与和研究.

关键词:

进行比较的手臂.复杂的健康干预措施.方法论方法论方法论随机对照试验是随机对照试验.通常的护理.

更多相关视频

Development of a Virtual Reality Assessment of Everyday Living Skills

Development of a Virtual Reality Assessment of Everyday Living Skills

Published on: April 23, 2014

A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition

A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition

Published on: September 20, 2019

相关概念视频

Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches

Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches

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,...

Clinical Trials

Clinical Trials

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...

Blinding

Blinding

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.

Crossover Experiments

Crossover Experiments

Crossover experiments, also called the repeated-measurements design, is a study design in which all experimental units are exposed to all treatments in different periods. Crossover experiments are generally used in psychology, the pharmaceutical industry, agriculture, and medicine.
Crossover designs are performed even with smaller sample sizes since the samples can act as their controls. These are better than simple randomized trials since patients are exposed to all the treatments.

Hazard Ratio

Hazard Ratio

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...

Clinical Trials: Overview

Clinical Trials: Overview

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...