在CODA试验中支持共享决策的通用对对比比较
Samuel Salvaggio1, Sarah E Monsell2, Patrick J Heagerty2
1One2Treat, Louvain-la-Neuve, Belgium.
JAMA network open
|March 31, 2025
概括
通用对对比 (GPC) 可以通过分析多个结果来帮助共享决策 (SDM). 这项研究使用了GPC与CODA试验数据,以显示治疗效益如何根据患者优先事项而有所不同.
科学领域:
- 相对有效性研究研究比较
- 医疗保健服务研究 医疗服务研究
- 生物统计学 生物统计学
背景情况:
- 通过评估多种治疗结果,共同决策 (SDM) 受到挑战.
- 一般化的对对比 (GPC) 提供了一种严格的方法来分析多结果数据.
- 通过系统地评估各种结果,GPC有可能增强SDM.
研究的目的:
- 评估通用对对比 (GPC) 在支持共享决策 (SDM) 中的实用性.
- 将GPC应用于来自抗生素药物和尾切除 (CODA) 试验结果比较的个体患者数据.
主要方法:
- 一项使用多中心美国CODA试验 (2016年5月至2020年3月) 数据的比较有效性研究.
- 在治疗手臂 (抗生素与尾切除手术) 中形成所有可能的患者对,对七个结果进行顺序分析.
- 分析了2020年2月至2024年初的数据,考虑了三个不同的优先级场景.
主要成果:
- 这项研究包括1552名患者 (每臂776名).
- 治疗净效益 (NTB) 在不同情景中有显著差异:12.8%赞成抗生素,3.2%赞成两者都不是,-14.5%赞成尾切除.
- 结果表明,感知到的利益风险平衡高度依赖于结果的优先级.
结论:
- GPC方法提供了一个灵活而严格的定量分析,用于比较治疗的益处与风险.
- 根据优先考虑的结果,GPC提供了对治疗方式之间的差异的细微评估.
- 这种方法可以通过将个体患者的优先事项纳入多种结果来显著支持SDM.
相关概念视频
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
Bioequivalence: Overview
949
Pharmaceutical equivalents, by definition, are drug products with the same active ingredient in the same quantities, encapsulated in identical dosage forms, and intended for the same administration routes. These pharmaceutical equivalents are deemed bioequivalent if the bioavailability of the active entity in the drug preparations is similar. Moreover, pharmaceutical equivalents demonstrating bioequivalence are also regarded as therapeutically equivalent. This means that when used as directed,...
949
Clinical Trials
6.6K
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...
6.6K
Odds Ratio
114
The odds ratio (OR) is a statistical measure used extensively in epidemiology and research to quantify the strength of association between exposure and outcome across different groups. Unlike relative risk, which compares the probabilities of an event occurring, the odds ratio compares the odds of an event occurring in the exposed group to the odds of it occurring in the unexposed group. The odds, in this context, are calculated as the probability of the event happening divided by the...
114
Multiple Comparison Tests
3.9K
Multiple comparison test, abbreviated as MCT, is a post hoc analysis generally performed after comparing multiple samples with one or more tests. An MCT will help identify a significantly different sample among multiple samples or a factor among multiple factors.
It would be easy to compare two samples using a significance alpha level of 0.05. In other words, there is only one sample pair to be compared. However, it would be difficult to identify a significantly different sample if the number...
It would be easy to compare two samples using a significance alpha level of 0.05. In other words, there is only one sample pair to be compared. However, it would be difficult to identify a significantly different sample if the number...
3.9K
Wilcoxon Signed-Ranks Test for Matched Pairs
107
The Wilcoxon signed-rank test for matched pairs evaluates the null hypothesis by combining the ranks of differences with their signs. It essentially tests whether the median of the differences in a population of matched pairs is zero. Since the test incorporates more information than the sign test, it generally yields more trustable conclusions. This test also does not require the data to follow a normal distribution, but two conditions must be met for it to be applicable: (1) the data must...
107


