ZHANG Fuqiang,HU Ziteng,ZHANG Yujing,et al.Methodology for the Development of Clinical Practice Guidelines for Chinese Patent Medicine (Part 8): Quality Evaluation with AGREE Ⅱ and RIGHT[J].Journal of Traditional Chinese Medicine,2024,65(02):185-191.
ZHANG Fuqiang,HU Ziteng,ZHANG Yujing,et al.Methodology for the Development of Clinical Practice Guidelines for Chinese Patent Medicine (Part 8): Quality Evaluation with AGREE Ⅱ and RIGHT[J].Journal of Traditional Chinese Medicine,2024,65(02):185-191.DOI: 10.13288/j.11-2166/r.2024.02.012.
Methodology for the Development of Clinical Practice Guidelines for Chinese Patent Medicine (Part 8): Quality Evaluation with AGREE Ⅱ and RIGHT
基于国际公认评价指南的方法学质量工具AGREE Ⅱ(the appraisal of guidelines for research and evaluation Ⅱ) 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。
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) Ⅱ and reporting items for practice guidelines in healthcare (RIGHT), thereby providing refe-rence for the clinical application and future development of CPM guidelines.
Methods
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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 AGREE Ⅱand 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
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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 AGREE Ⅱ domains 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 AGREE Ⅱ (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
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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 AGREE Ⅱ and 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.
BROUWERS MC , KHO ME , BROWMAN GP , et , al . AGREE Ⅱ:advancing guideline development, reporting and evaluation in health care [J]. CMAJ , 2010 , 182 ( 18 ): E839 - E842 .
CHEN Y , YANG K , MARUSIC A , et al . A reporting tool for practice guidelines in health care:the RIGHT statement [J]. Ann Intern Med , 2017 , 166 ( 2 ): 128 - 132 .
AGREE Collaboration . Development and validation of an international appraisal instrument for assessing the quality of clinical practice guidelines: the AGREE project [J]. Qual Saf Health Care , 2003 , 12 ( 1 ): 18 - 23 .
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