Appraising the quality of clinical practice guidelines in Chinese patent medicine

Abstract

BackgroundChinese patent medicine (CPM) is a type of traditional Chinese medicine (TCM) that utilizes Chinese medicinal materials as its raw ingredients. Following the principles of TCM theory, it undergoes specific processing techniques to create various dosage forms for the prevention and treatment of diseases. The current CPM guidelines, both domestically and internationally, are constrained by limitations in methodological quality and reporting, which do not adequately address the requirements of the majority of clinicians and patients. ObjectiveTo evaluate the methodological rigor and reporting quality of clinical practice guidelines (CPGs) in CPM, with aim to assess their current quality and to provide recommendations for improving guideline development. MethodsThe study utilized the Appraisal of Guidelines for Research and Evaluation II (AGREE II) tool and the Reporting Items for Practice Guidelines in Healthcare for Traditional Chinese Medicine (RIGHT for TCM) checklist to evaluate the methodological rigor and reporting quality of CPM guidelines. After the training session, the four investigators were divided into two groups to evaluate the guidelines of patent Chinese medicine included in this study based on the aforementioned criteria. In case of any discrepancies, a secondary analysis was conducted by all four researchers under the guidance of two clinical experts, ensuring an impartial evaluation outcome. Average score or average reporting rate were calculated for each domain. ResultsA total of 32 CPM guidelines that met the inclusion criteria were analyzed. The AGREE II yielded an average score of 67.2%. The domain scores were as follows: scope and purpose (93.3%), stakeholder involvement (50.1%), rigor of development (76.8%), clarity of presentation (79.4%), applicability (40.1%), and editorial independence (63.6%). The average reporting rate of the RIGHT for TCM checklist was 70.0%, with the reporting rates for the seven domains as follows: basic information (94.2%), background (87.9%), evidence (97.5%), recommendation (57.5%), review and quality assurance (11.4%), funding and declaration and management of interests (26.6%), and other information (68.8%). ConclusionsThe methodological and reporting quality of CPGs for CPM have been deemed acceptable since 2020. However, there is still room for improvement, particularly in enhancing the reporting quality to provide clinicians and patients with more effective and comprehensive guidance. Additionally, it may be beneficial to develop a comprehensive reporting checklist specifically tailored for CPM guideline development.