Xu Jianguo, Zheng Qingyong, Cui Yating, Wang Junfei, Xie Yafei, Li Lin, Gao Ya, Liu Ming, Qin Yu, Sun Jiaxuan, Yi Kang, Tian Jinhui
Evidence-Based Medicine Center, School of Basic Medical Sciences, Lanzhou University, Lanzhou, China.
Population Health Research Institute, Hamilton, Canada.
Cardiovasc Drugs Ther. 2025 Feb 18. doi: 10.1007/s10557-025-07679-0.
Transcatheter aortic valve replacement (TAVR) has emerged as a critical innovation for managing severe aortic stenosis, prompting the development of numerous clinical practice guidelines worldwide. This study systematically evaluates the guideline development methodologies of major international TAVR guidelines using the AGREE II and AGREE-REX instruments, aiming to enhance understanding of current development processes.
A comprehensive search was conducted in PubMed, Embase, Web of Science, and specialized guideline repositories. Twenty-four TAVR-specific guidelines were independently evaluated by four reviewers using the AGREE II and AGREE-REX instruments. The guidelines were categorized as evidence- or consensus-based, and statistical analysis was performed using SPSS to standardize scores and assess inter-rater reliability.
Systematic assessment revealed significant methodological variations across guidelines. The AGREE II evaluation showed the highest performance in scope and purpose (83.9 ± 10.0%) but lower scores in rigor of development (43.5 ± 29.0%) and applicability (42.4 ± 26.8%). The AGREE-REX analysis demonstrated stronger performance in implementability (78.6 ± 14.5%) while identifying gaps in the integration of values and preferences (35.7 ± 17.2%). Evidence-based guidelines consistently outperformed consensus-based ones across multiple domains, particularly in terms of methodological rigor and implementation planning.
This evaluation highlights key areas for improving guideline development methodology, including standardized evidence evaluation processes, systematic stakeholder engagement, and structured implementation planning. The considerable variability in methodological quality underscores the need for more standardized approaches.
Current TAVR guidelines exhibit significant heterogeneity in methodological quality, with evidence-based guidelines demonstrating superior performance in development rigor and implementation planning. Systematic approaches to evidence synthesis and stakeholder engagement are crucial for high-quality guideline development.
经导管主动脉瓣置换术（TAVR）已成为治疗严重主动脉瓣狭窄的一项关键创新技术，促使全球众多临床实践指南得以制定。本研究使用AGREE II和AGREE-REX工具系统评估主要国际TAVR指南的制定方法，旨在加深对当前制定过程的理解。
在PubMed、Embase、科学网和专业指南库中进行全面检索。由四名评审员使用AGREE II和AGREE-REX工具对24项TAVR特定指南进行独立评估。这些指南被归类为基于证据或基于共识的，并使用SPSS进行统计分析以标准化评分并评估评分者间的可靠性。
系统评估显示各指南在方法上存在显著差异。AGREE II评估在范围和目的方面表现最佳（83.9±10.0%），但在制定的严谨性（43.5±29.0%）和适用性（42.4±26.8%）方面得分较低。AGREE-REX分析在可实施性方面表现更强（78.6±14.5%），同时发现了在价值观和偏好整合方面的差距（35.7±17.2%）。在多个领域，基于证据的指南始终优于基于共识的指南，特别是在方法严谨性和实施规划方面。
本次评估突出了改进指南制定方法的关键领域，包括标准化的证据评估过程、系统的利益相关者参与以及结构化的实施规划。方法质量的显著差异凸显了采用更标准化方法的必要性。
当前TAVR指南在方法质量上存在显著异质性，基于证据的指南在制定严谨性和实施规划方面表现更优。系统的证据综合和利益相关者参与方法对于高质量指南的制定至关重要。
