Real-world data is been increasingly valued nowadays. This paper combined with related requirements of clinical evaluation of medical devices in China, studied the role of real-world evidence in pre-marketing clinical evaluation of medical devices in terms of technical evaluation, in aim of providing reference for the future application of China's real-world evidence in pre-marketing clinical evaluation.
ObjectiveTo evaluate the implementability of traditional Chinese medicine (TCM) guidelines in the field of paediatrics. MethodsWe searched the paediatrics-related TCM guidelines published in CNKI, WanFang Data, VIP, SinoMed and PubMed databases, and related websites from inception to November 1, 2023. The implementability of the included guidelines was evaluated using the clinical practice guideline implementability assessment tool. ResultsA total of 47 guidelines were included, covering 37 paediatric diseases and recommending 27 TCM therapies, including TCM decoction, Chinese patent medicines, acupuncture, paediatric massage, and acupoints. The results of the guideline accessibility evaluation showed that, in terms of the overall quality of accessibility, 5 guidelines (10.6%) were of high grade, 12 guidelines (25.5%) were of medium grade, and 30 guidelines (63.8%) were of low grade. With the exception of accessibility (multi-channel access methods) and communicability, which was of high quality, there is room for improvement in all areas, particularly in the areas of applicability and ease of recognition. ConclusionThe overall quality of implementability of the included paediatric TCM guidelines was low, and it is recommended that in the process of developing paediatric TCM guidelines in the future, we focus on improving the quality of implementability of the guidelines themselves from the source, so as to promote the implementation and application of the guidelines.
ObjectiveTo explore the items affecting the prioritization of clinical questions and to construct an evaluation scale for prioritizing clinical question of traditional Chinese medicine (TCM) guidelines. MethodsLiterature analysis and cognitive interview were used to construct the pool of items for evaluating the prioritization of clinical questions of TCM guidelines, and Delphi methods was used to identify the items to form the evaluation scale. ResultsA total of 47 articles were included in the literature, and the two rounds of Delphi questionnaires had a recovery rate of 72% and 100%, respectively. The mean value of the importance of the items in the first round ranged from 3.78 to 4.78, with a coefficient of variation ranging from 0.09 to 0.30, and the mean value in the second round ranged from 4.06 to 4.72, with a coefficient of variation ranging from 0.09 to 0.29. The evaluation scale for the prioritization of clinical questions of TCM guidelines (first edition) was constructed, which contains 13 entries in 4 dimensions. ConclusionThis study explored the items affecting the prioritization of clinical questions in TCM guidelines and developed a prioritization evaluation scale, which improved the lack of objectivity and interpretability of the current prioritization of clinical questions in TCM guidelines to a certain extent, and strengthened the transparency of the process of selecting clinical issues in TCM guidelines.
Objective To analyze the current research status, characteristics and development trends of traditional medicine-related clinical trials registration, and to provide ideas and directions for further development of traditional medicine clinical trials. Methods The International Traditional Medicine Clinical Trial Registry (ITMCTR) database was searched by computer from inception to June 30, 2024, with unlimited trial registration status, to collect all the clinical trials on traditional medicine, and analyze the basic information of the trials, the diseases studied and the interventions. Results A total of 4 349 clinical trials related to traditional medicine were included, with the number of registrations peaking in the second half of 2020, and showing a steady upward trend after 2023. The trial sponsors of the study covered 9 countries and a total of 34 provinces/autonomous regions/municipalities in China, led by Beijing, Shanghai, Guangdong, Sichuan, and Zhejiang provinces, accounting for 69.72% of the total. The financial support for the studies was dominated by local government funds in various provinces and cities, accounting for 29.66%. Disease types studied were mainly circulatory system diseases, musculoskeletal system or connective tissue diseases, and tumor diseases, accounting for 29.91% of the total. A total of 3 751 (86.3%) clinical trials were interventional studies, of which randomized parallel control was predominant, and 213 large-sample studies with a sample size of more than 1 000 cases were included. A total of 20 types of interventions were involved, of which 1 114 (29.86%) clinical trials utilized oral prescription of herbal medicine interventions. Conclusion Clinical trial enrollment in traditional medicine has increased overall, but with significant geographic unevenness. Oral herbal soup/granule intervention studies are the mainstream hotspots. It is recommended to strengthen international cooperation, enrich the types of interventions, refine the trial design, and raise the awareness of researchers about the registration of high-quality traditional medicine clinical trials.