eACT研究的设计和方法:一个连续的,多次分配的,随机的试验,对患有的青少年进行一种新的坚持干预
Janelle L Wagner1, Anup D Patel2, Heather Huszti3
1College of Nursing, Medical University of South Carolina, Charleston, SC, USA.
Contemporary clinical trials
|November 12, 2024
概括
这项研究测试了一种行为干预措施,以改善症儿童的抗药物坚持. 顺序,多重分配,随机试验 (SMART) 设计旨在增强药物坚持和健康结果.
科学领域:
- 儿科神经学 儿科神经学
- 行为健康干预 行为健康干预
- 临床试验设计 临床试验设计
背景情况:
- 是一种常见的慢性儿科神经疾病.
- 抗发作药物 (ASM) 是主要的治疗方法,但对约60%的年轻人来说,坚持是个挑战.
- 这项研究的重点是改善患有的幼儿的ASM坚持.
研究的目的:
- 测试行为健康干预措施的有效性,以改善的幼儿家庭的抗药物 (ASM) 坚持.
- 评估干预对发作自由,医疗保健利用和生活质量的影响.
- 描述顺序,多重分配,随机试验 (SMART) 的方法,招聘和基线特征.
主要方法:
- 两阶段的SMART设计招募了466名种族和种族多样化的青年 (2-12岁) 患有新诊断的.
- 经过8周的运行,268个不遵守的家庭被随机分配到控制 (教育 + 数字提醒) 或干预 (教育 + 数字提醒 + 个性化反).
- 干预组中不遵守的家庭被重新随机选择继续干预或接受远程医疗解决问题的会议.
主要成果:
- 主要结果是电子监控的ASM遵守.
- 其次要结果包括无发作,医疗保健利用率和特异性健康相关的生活质量.
- 研究措施在基线和基线后8,14,20个月收集.
结论:
- 该研究采用了新的试验设计方面,包括顺序随机化和招募多样化的年轻人.
- 由于COVID-19大流行和不断变化的社会政治和医疗气候,进行了修改.
- 遇到的招聘和留住挑战,并将讨论.
相关概念视频
01:16Crossover Experiments
2.7K
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.
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.
2.7K
01:11Blinding
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
01:13Randomized Experiments
6.7K
The randomization process involves assigning study participants randomly to experimental or control groups based on their probability of being equally assigned. Randomization is meant to eliminate selection bias and balance known and unknown confounding factors so that the control group is similar to the treatment group as much as possible. A computer program and a random number generator can be used to assign participants to groups in a way that minimizes bias.
Simple randomization
Simple...
Simple randomization
Simple...
6.7K
02:07Blind Procedures
10.6K
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...
10.6K