重新考虑步骤集团随机试验设计与实施期:较少的序列或具有基线和实施期的并行组设计可能更有效
Philip M Westgate1, Shawn R Nigam1, Abigail B Shoben2
1Department of Biostatistics, College of Public Health, University of Kentucky, Lexington, KY, USA.
Clinical trials (London, England)
|April 23, 2024
概括
修改后的阶梯形设计可以提高集群随机试验的效率. 仅使用第一个和最后一个序列的修改设计比三个序列的设计更有效,特别是与较低的集群相关性.
科学领域:
- 临床试验方法论 临床试验方法论
- 生物统计学 生物统计学
- 公共卫生研究 公共卫生研究
背景情况:
- 集群随机试验 (CRT) 需要精心设计,平衡效率和实用性.
- 阶梯形设计 (SWD) 在CRT中很受欢迎,因为它可能提高效率.
- 在CRT中的实施期,干预措施需要时间来采用,这是一个关键的设计考虑因素.
研究的目的:
- 为了比较不同CRT设计的效率,包括SWD与实施期.
- 对标准SWD进行修改SWD和并行组设计的评估.
- 评估实施期和相关结构对设计效率的影响.
主要方法:
- 将三序式SWD的效率与修改和并行组设计的实施期进行比较.
- 分析了4个以上序列的SWD与删除中间序列的修改设计相比.
- 利用线性混合效应模型和协差分析进行效率评估.
主要成果:
- 经过修改的SWD设计比具有实施周期的三序SWD更有效.
- 具有基线和实施周期的并行组设计往往优于三序SWD.
- 修改设计的效率增长取决于相关性结构;较低的自相关性通常会增加相对效率.
结论:
- 对于三序式SWD,考虑修改设计 (第一个和最后一个序列) 以提高效率.
- 具有实施期限的并行组设计提供了一个实用和高效的替代方案.
- 对于具有更多序列的SWD,建议修改设计以删除中间序列;仔细考虑相关性.
相关概念视频
01:13Randomized Experiments
6.9K
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...
6.9K
01:20Cluster Sampling Method
11.9K
Appropriate sampling methods ensure that samples are drawn without bias and accurately represent the population. Because measuring the entire population in a study is not practical, researchers use samples to represent the population of interest.
To choose a cluster sample, divide the population into clusters (groups) and then randomly select some of the clusters. All the members from these clusters are in the cluster sample. For example, if you randomly sample four departments from your...
To choose a cluster sample, divide the population into clusters (groups) and then randomly select some of the clusters. All the members from these clusters are in the cluster sample. For example, if you randomly sample four departments from your...
11.9K
01:16Crossover Experiments
2.8K
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.
2.8K
01:20Comparing the Survival Analysis of Two or More Groups
178
Survival analysis is a cornerstone of medical research, used to evaluate the time until an event of interest occurs, such as death, disease recurrence, or recovery. Unlike standard statistical methods, survival analysis is particularly adept at handling censored data—instances where the event has not occurred for some participants by the end of the study or remains unobserved. To address these unique challenges, specialized techniques like the Kaplan-Meier estimator, log-rank test, and...
178
01:20Study Designs in Epidemiology
215
Epidemiological study designs are fundamental tools for investigating the distribution, determinants, and control of health conditions in populations. They help researchers understand the relationships between exposures and outcomes, and they broadly fall into two categories: "observational" and "experimental" studies.
Observational studies are those where the researcher does not intervene but rather observes natural variations. They include cross-sectional, cohort, and...
Observational studies are those where the researcher does not intervene but rather observes natural variations. They include cross-sectional, cohort, and...
215
01:12Hazard Ratio
115
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...
For example, in a clinical trial...
115