目的:分析方法学,证据,recommendations,质量,和实施中成药(CPM)指南。
方法:检索2019-2022年发布的CPM临床应用指南。由两名评估者进行独立筛选和数据提取。有关指南的基本信息,包括证据和建议,进行提取和统计分析。使用实施评估工具和研究与评估指南(AGREE)II评估质量和实施情况。
结果:总计,分析了29条指南,包括262条建议和2,308条参考。所有CPM指南都遵循“证据为核心”的原则,共识作为补充,和经验作为参考“以及世卫组织手册提供的方法。每个指南中平均引用了89篇参考文献,每个建议中平均引用了8篇参考文献。随机对照试验和系统评价占89%和0.9%,分别,所有参考文献。低质量或极低质量的证据占74.5%,弱建议占83.6%。在所有建议中,13.7%基于专家共识,9.5%的强推荐是基于低质量或极低质量的证据.每个领域的AGREEII得分分别为:范围和目的(79.63%)和编辑独立性(79.27%),其次是表述的清晰度(72.59%),利益相关者参与(69.99%),发展的严谨性(53.97%)和适用性(5.11%)。大多数指南的实施质量为高(44.8%)或中等(55.2%)。
结论:CPM指南的结果在方法学方面令人印象深刻,质量,和执行。然而,对CPM建议的信心因证据质量低而降级.
OBJECTIVE: To analyze the methodology,
evidence, recommendations, quality, and implementation of traditional Chinese patent medicine (CPM) guidelines.
METHODS: We retrieved clinical application guidelines of CPM published from 2019 to 2022. Independent screening and data extraction were performed by two evaluators. The basic information about the guidelines, including
evidence and recommendations, were extracted and statistically analyzed. Quality and implementation were evaluated using the Implementation Evaluation Tool and Appraisal of Guidelines for Research & Evaluation (AGREE) II.
RESULTS: In total, 29 guidelines were analyzed, including 262 recommendations and 2308 references. All the CPM guidelines followed the principle of \"
evidence as a core, consensus as a supplement, and experience as a reference\" and the methods provided by WHO Handbook. An average of 89 references were cited in each guideline and 8 in each recommendation. Randomized controlled trials and systematic reviews constituted 89 % and 0.9 %, respectively, of all references. Low or very low-quality
evidence characterized 74.5 % and weak recommendations characterized 83.6 %. Of all recommendations, 13.7 % were based on expert consensus, and 9.5 % of strong recommendations were based on low or very low-quality evidence. The AGREE II scores for each domain were: scope and purpose (79.63 %) and editorial independence (79.27 %), followed by clarity of presentation (72.59 %), stakeholder involvement (69.99 %), rigor of development (53.97 %) and applicability (5.11 %). The implementation quality of most guidelines was either high (44.8 %) or moderate (55.2 %).
CONCLUSIONS: The results for CPM guidelines were impressive in terms of methodology, quality, and implementation. However, confidence in CPM recommendations was downgraded by low quality of
evidence.