中成药临床实践指南制定方法(八)——基于AGREEⅡ和RIGHT的中成药临床实践指南质量评价

Methodology for the Development of Clinical Practice Guidelines for Chinese Patent Medicine(Part 8):Quality Evaluation with AGREEⅡand RIGHT

目的基于国际公认评价指南的方法学质量工具AGREEⅡ(the appraisal of guidelines for research and evaluationⅡ)及国际实践指南报告标准(reporting items for practice guidelines in healthcare,RIGHT)清单评价中成药临床实践指南的方法学和报告质量,分析报告内容中的不足之处,以期为中成药临床应用及后续指南的制定提供参考。方法检索中国知网、重庆维普中文科技期刊数据库、万方医学网和中国生物医学数据库,补充检索医脉通、中华中医药学会和中华医学会网站并追溯纳入文献的参考文献,收集中成药临床实践指南。采用AGREEⅡ和RIGHT清单评价指南质量,使用组内相关系数进行一致性检验,采用描述性分析和卡方检验分析各领域报告率和各条目平均得分。结果最终纳入140部中成药临床实践指南,其中51部为以病为纲类,89部为以药为纲类,均为中国发布。以病为纲类在AGREEⅡ6个领域平均得分率最高为表达的清晰性73.32%,最低为应用性26.80%;以药为纲类在AGREEⅡ6个领域平均得分率最高为范围和目的55.62%,最低为制定严谨性31.32%。以病为纲类在RIGHT清单7个领域平均报告率最高为背景68.26%,最低为评审和质量保证13.73%;以药为纲类在RIGHT清单7个领域平均报告率最高为背景61.31%,最低为其他方面4.49%。统计分析结果显示,以病为纲类中成药临床实践指南在AGREEⅡ的3个领域(制定严谨性、表达的清晰性、编辑的独立性)和RIGHT清单的4个领域(基本信息、证据、资助与利益冲突声明和管理、其他方面)的平均报告率均高于以药为纲类中成药临床实践指南(P<0.05)。结论本研究纳入的140部中成药临床实践指南总体方法学和报告质量均有待提高,纳入文献的推荐等级多为B级和C级,难以直接应用于临床诊疗决策过程中,建议未来指南制定团队应严格参照AGREEⅡ和RIGHT清单制定相关指南以指导中成药的临床应用。

Objective To evaluate the methodological and reporting quality of clinical practice guidelines for Chinese patent medicine(CPM)with internationally recognized tools the appraisal of guidelines for research and evaluation(AGEREE)Ⅱand reporting items for practice guidelines in healthcare(RIGHT),thereby providing refe-rence for the clinical application and future development of CPM guidelines.Methods Databases including CNKI,VIP,Wanfang and Sinomed were searched for CPM guidelines,as well as medlive.cn,websites of China Association of Chinese Medicine and Chinese Medical Association,and reference lists of the included papers.The quality of the guidelines was evaluated using the AGREEⅡand RIGHT tools,and consistency tests were performed using Interclass Correlation Coefficient,and descriptive analysis and chi-square test were used to analyze the reporting rate for each domain and the average score for each item.Results Finally,140 CPM guidelines were included,of which 51 were disease-oriented and 89 were drug-oriented,all of which were issued by China.For 51 disease-oriented CPM guidelines,the highest average score of all six AGREEⅡdomains was 73.32%for clarity,and the lowest was 26.80%for application;for 89 drug-oriented CPM guidelines,the highest average score was 55.62%for scope and purpose,and the lowest was 31.32%for rigour of development.In terms of the seven domains of the RIGHT checklist,the highest reporting rate was 68.26%for background,and lowest was 27.45%for other areas regarding the disease-oriented CPM guidelines;the highest reporting rate was 61.31%for background,and the lowest was 4.49%for other areas regarding drug-oriented CPM guidelines.The average reporting rate was higher for disease-oriented than drug-oriented CPM guidelines in three domains of AGREEⅡ(rigour of development,clarity of presentation,editorial independence),as well as four domains of RIGHT checklist(basic information,evidence,funding and declaration and management of interests,and other areas).Conclusion The overall methodology and reporting quality of the current CPM guidelines still need to be improved.It is recommended that future guideline development teams should strictly refer to the AGREEⅡand RIGHT checklist,and take into account of the characteristics of CPM guidelines and relevant methodo-logical suggestions in the development and reporting of CPM guidelines,thereby guiding the clinical use of CPM in a better way.