医疗技术评估中的综合终点:第二部分 - - 扩大证据基础,以一个最佳模式实践框架来扩大证据基础
Andrew Briggs1, Jieling Chen2, David Booth3
1Department of Health Services Research & Policy, London School of Hygiene & Tropical Medicine, London, UK.
Journal of comparative effectiveness research
|September 10, 2025
概括
卫生技术评估 (HTA) 应考虑关键试验以外的其他证据. 这有助于决定是否使用复合终点或分析多种药物或适用于多种适应症的单个成分.
科学领域:
- 药物经济学 药物经济学
- 临床试验分析
- 卫生技术评估 卫生技术评估
背景情况:
- 在医疗技术评估 (HTA) 中,复合终点至关重要.
- 在建模中检查了使用复合估计与分类组件终点的先前工作.
- 这篇论文将分析扩展到关键试验以外的证据.
研究的目的:
- 探索在HTA中使用额外的证据,包括同一类药物中的不同药物的数据或不同指示的相同药物的数据.
- 展示这种扩展的证据库如何能够为有关复合终点的决策提供信息.
主要方法:
- 继续进行一项涉及达帕格利弗洛辛心力衰竭的病例研究,其中保留或轻微减少喷射分数.
- 扩大证据库,以包括同一个适用于相同指示的empagliflozin.
- 包括两种药物在心力衰竭和减少喷射率的数据.
主要成果:
- 当某一类或多种适用性存在多种药物时,HTA应评估关键试验以外的研究信息的可交换性.
- 考虑这些额外的证据有助于决定分解复合终点或使用复合治疗效应.
结论:
- 医疗价值评估可以从考虑更广泛的证据基础中获益,包括相关药物和适应症的数据.
- 这种方法支持关于在治疗效应建模中使用和解释复合终点的知情决策.
相关概念视频
Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches
409
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,...
409
Methods of Documentation VI: Case Management Model
864
The case management model is a multidisciplinary approach that involves healthcare professionals from diverse disciplines, such as physicians, nurses, therapists, social workers, and pharmacists, working collaboratively to address the various needs of patients. Each healthcare professional brings unique expertise and perspectives, contributing to a more comprehensive understanding of the patient's condition and tailoring treatment plans accordingly.
For example, a patient with a chronic...
For example, a patient with a chronic...
864
Health Information Technology and Healthcare Information System
3.3K
Health Information Technology (HIT)
Health Information Technology, commonly called HIT, integrates advanced information systems and technology in healthcare settings. Its primary functions include:
Health Information Technology, commonly called HIT, integrates advanced information systems and technology in healthcare settings. Its primary functions include:
3.3K
Models of Health Promotion and Illness Prevention I
2.7K
A model is a theoretical way to understand a concept or an idea. Models can overcome barriers to health regardless of diverse economic and cultural backgrounds. In addition, models make the task easier by providing different ways to approach complex issues. There are two major health promotion models: the health belief model and the health promotion model.
The health belief model (HBM) attempts to predict health-related behavior in specific belief patterns. According to the HBM, a person's...
The health belief model (HBM) attempts to predict health-related behavior in specific belief patterns. According to the HBM, a person's...
2.7K
Methods of Documentation V: CBE
1.4K
Charting by Exception, or CBE, is a method of documentation used in healthcare, particularly in nursing, that focuses on documenting only significant or abnormal findings rather than recording every detail. This approach aims to streamline the documentation process, improve efficiency, and ensure that healthcare providers can quickly identify deviations from normalcy in patient assessments.
In CBE, healthcare professionals establish predefined standards of practice that define what constitutes...
In CBE, healthcare professionals establish predefined standards of practice that define what constitutes...
1.4K
Pharmacokinetic Models: Comparison and Selection Criterion
341
Physiological and compartmental models are valuable tools used in studying biological systems. These models rely on differential equations to maintain mass balance within the system, ensuring an accurate representation of the dynamic processes at play.
Physiological models take a detailed approach by considering specific molecular processes. They can predict drug distribution, metabolism, and elimination changes, providing a comprehensive understanding of how drugs interact with the body.
Physiological models take a detailed approach by considering specific molecular processes. They can predict drug distribution, metabolism, and elimination changes, providing a comprehensive understanding of how drugs interact with the body.
341

