Objective To evaluate quality and current status of traditional Chinese medicine (TCM) guidelines and consensus, and to promote the improvements in the quality of guidelines and consensus. Methods A systematic collection of TCM guidelines and consensus published in medical journals in 2022 was conducted. We used scientific, transparent, and applicable ranking tools (STAR) for evaluation, analyzed the scoring rates (%), and assessed the quality level and influencing factors of guidelines and consensus through methods such as comparison and stratification. Results A total of 130 TCM guidelines and consensus were included. Guideline areas with higher scores included recommendations (65.3%), evidence (55.9%), and guideline development groups (54.2%). In the case of consensus, higher scores were observed in recommendations (38.7%), guideline development groups (37.0%), and funding (30.0%). The total score rate of TCM guidelines exceeded that of national guidelines, while the consensus rate was lower. Stratified analysis revealed statistical differences in guideline score rates among journals and issuing institutions, as well as significant differences in consensus score rates among journals, formulation institutions, subjects, and funding categories. Conclusion The quantity and quality of TCM guidelines and consensus are on a positive trajectory, with higher quality levels in guidelines than in consensus. The overall quality of TCM guidelines surpasses that of national guidelines, particularly emphasizing the scientificity of guideline formulation. However, the overall quality of consensus remains lower than that of the national consensus. Factors such as journals, formulation institutions, subjects, and funding categories are identified as potential influences on the quality of TCM guidelines and consensus.
吸入疗法是治疗呼吸系统疾病的常用方法, 包括气雾吸入、经储雾罐气雾吸入、干粉吸入以及雾化吸入等, 而以雾化吸入疗效最确切, 适应证也最广泛。但是, 关于雾化吸入治疗的用药方案以及药物配伍信息却非常有限。近期美国卫生系统药师协会发表的常用雾化吸入药物混合配伍指南[ 1 ] 提出了可供雾化吸入的药物及其配伍的各种推荐意见, 并采用表格形式便于临床医生理解和掌握。成人慢性气道疾病雾化吸入治疗专家组在该指南的基础上, 结合中国呼吸道疾病雾化吸入治疗现状, 制定了雾化吸入药物治疗共识, 同时根据不同的疾病提出雾化治疗推荐方案, 以供临床医师参考。
Clinical practice guidelines are decision-making tools for bridging the gap between current best evidence and clinical practice. Studies have shown poor clinical applicability of existing guidelines, which may not be solved by improving the quality of guidelines alone. National medical management service guidance center is developing clinical practice guidelines of clinical evaluation system of construction projects, based on evidence-based method formulated by the target users of clinical guidelines evaluators’ applicability evaluation system of clinical practice guidelines. It aims to identify guidelines with high clinical applicability and provide the evaluation results of clinical applicability to developers and revisers of clinical guidelines, and then optimize the development and update, eventually improving the clinical applicability of guides and promote Chinese clinical guidelines in clinical application.
The management of middle-aged and youth hypertension has become a challenge in clinical practice. The hypertension group of the Chinese Society of Cardiology published the expert consensus on the management of hypertension in young and middle-aged Chinese population in 2019. This paper interprets the key contents of the consensus and provides references for management of young and middle-aged hypertension.
Objective To verify the applicability of AGREE-China and select high-quality clinical practice guidelines (CPGs) or consensus for the management of fragility fractures (FF) in China by evaluating their methodological quality. Methods CBM, CNKI, WanFang Data, VIP databases and related CPGs websites were electronically searched. Two reviewers independently screened literature, extracted data, and checked each other. Quality appraisal of CPGs or consensus were evaluated by AGREE Ⅱ and AGREE-China, and weighted Kappa value and intraclass correlation coefficients (ICC) were calculated to illustrate the consistency of the two tools. Results Nine CPGs and sixteen consensuses were included. Among the six domains in AGREE Ⅱ, "scope and purpose" domain (62.22%) scored higher than "clarity of presentation" domain (45.67%). The "stakeholder involvement" domain (34.89%) and "applicability" domain (38.17%) both exceeded 30%, while "rigor of development" domain (18.79%) and "editorial independence" domain (13.33%) were lower. Among the five domains in AGREE-China, "conflict of interest" domain (72.80%) was higher, followed by "usability/feasibility" domain (49.87%), while "scientificity/preciseness" domain (20.36%), "effectiveness/safety" domain (25.20%) and "economic efficiency" domain (14.40%) were lower. The weighted Kappa value of recommendations from the two tools was 0.694 (P<0.001), showing moderate consistency. ICC values of the same items and two evaluators were all greater than 0.85 (P<0.001) with high consistency. Three high-quality CPGs were consistently selected by the two tools. Conclusion AGREE Ⅱ holds high consistency with AGREE-China; however, AGREE-China is more suitable for the quality appraisal of Chinese CPGs or consensus. The methodological quality of CPGs or consensus for the management of FF in China needs to be further improved.
ObjectiveTo evaluate the scientificity, transparency and applicability of the Chinese consensuses on urological diseases published in 2021. MethodsPubMed, CBM, CNKI, WanFang Data databases and related websites were electronically searched to collect Chinese consensuses on urological diseases from January 1 to December 31, 2021. Each consensus was scored with the scientific, transparent, and applicable rating (STAR) tools, and analyzed by using descriptive methods. ResultsA total of 28 Chinese consensuses were included. The STAR scores ranged from 9.9 to 32.3 with a mean of 17.3±6.3. The included consensus had a high score ratio in the items such as listing participants and institutions, providing identifiable recommendations, explaining the precautions for implementation of recommendations, having corresponding references for recommendations, and reporting future research directions. However, only 14.3% reported the methodology of consensus formation, and the record of consensus process and consideration of patient preferences, values and costs were not noted. No consensus reported responsibilities of panel specialists in the method section or included experts in the field of guideline methodology or evidence-based medicine. No consensus reported detailed information in managing conflicts of interest. Few reported no affection by funding. No consensus reported methods for collecting and selecting clinical questions, or evaluating, summarizing and grading evidence. Research gaps were not reported in a clear or standardized way. ConclusionAs a medical guidance document, expert consensus still plays an important role now in China. The quality of consensus on urological diseases can be further improved in methods of consensus formation, working groups, conflicts of interest, funding, accessibility, clinical questions, retrieval and evaluation of evidence, research gap, etc.
ObjectivesTo assess the methodological quality of clinical practice guidelines of cervical cancer in China published from 2014 to 2018.MethodsCNKI, WanFang Data, CBM, VIP, Medlive.cn, the National Guideline Clearinghouse, PubMed, The Cochrane Library and EMbase were searched for cervical cancer clinical practice guidelines published in China from January 1st, 2014 to December 31st, 2018. Four reviewers searched and selected the literature independently according to the inclusion and exclusion criteria and assessed the methodological quality of the included guidelines by using AGREE Ⅱ.ResultsA total of 9 guidelines were included. The average score for each area was: scope and purpose 75.47%, stakeholders’ involvement 35.09%, the rigor of development 43.70%, clarity of presentation 87.74%, applicability 80.76%, and editorial independence 0%.ConclusionsThe quality of cervical cancer clinical practice guidelines in China requires further improvement.
Rapid development of recently emerging precision medicine techniques represented by gene therapy has brought hope for the treatment of rare blinding eye diseases such as inherited retinal diseases (IRDs) for which there was no effective treatment previously. Although the globally growth of clinical trials for IRDs has increased rapidly over the past decade, due to the highly genetic and clinical phenotypic heterogeneity, as well as limited data on epidemiology and natural history of the disease, along with severe loss of vision function of majority patients for which the established measurements may not be appropriate, such studies lack standard outcome measurements and endpoints to asses clinical meaningful effectiveness, posing great challenges in terms of study design and evaluation of treatment efficacy, as well as clinical practice application. At present, there is no systematic nor standardized guidance on safety measures, clinical outcomes and endpoints of visual function for clinical trial design in IRDs. Therefore, in order to standardize the validated evaluation of IRDs clinical efficacy outcome measurements and endpoints, the Fundus Disease Group of Chinese Medical Association Ophthalmology Branch and Fundus Disease Committee of Chinese Medical Doctor Association Ophthalmology Branch organized domestic experts to put forward consensus and recommendations on standardizing outcome measurements and endpoints for clinical study design in IRDs, aiming to advance the study design of IRDs natural history research and clinical trials and to effectively evaluate disease progression and intervention efficacy. Along with the development of medical science and clinical trials, relevant content will be improved and updated accordingly.
ObjectivesTo evaluate the methodological and reporting quality of clinical guidelines and consensus for esophageal cancer.MethodsDatabases including PubMed, EMbase, Web of Science, CBM, WanFang Data and CNKI were electronically searched and major guideline websites such as GIN, NICE, NGC and Yimaitong were also searched to collect guidelines and consensus for esophageal cancer from inception to August 2018. Two reviewers independently screened the literatures and extracted data according to the inclusion and exclusion criteria and then evaluated the quality of the included guidelines using the AGREE II and RIGHT instruments.ResultsA total of 26 esophageal cancer guidelines and consensus were included. The mean scores for each domain of AGREE II was 49.63% for scope and purpose, 25.16% for stakeholder involvement, 23.42% for rigor of development, 49.25% for clarity of presentation, 16.91% for applicability, and 21.07% for editorial independence. The item with the highest reporting rate among the RIGHT evaluation items was 5 (84.62%), followed by 1a (80.77%), 1c (65.38%), 13a (65.38%), and 4 (61.54%), and the remaining items were all reported below 50%. Results of subgroup analysis showed that the guidelines and consensus developed based on the evidence-based medicine method had higher average scores in the six domains of AGREE II and the RIGHT score than the guidelines and consensus developed based on expert opinions or reviews. The foreign guidelines and consensus had higher average scores in the three domains of AGREE II (formulation rigor, clarity, editorial independence) and the RIGHT score than the domestic guidelines.ConclusionsThe methodological and reporting quality of the guidelines and consensus on esophageal cancer is low, with the guidelines and consensus in China even lower, requiring further improvement. It is suggested that the guideline developers should refer to the standards such as AGREE II and RIGHT to develop high-quality guidelines and promote their application, so as to better guide the standardized diagnosis and treatment of esophageal cancer.
Insomnia is a major challenge to human health at present. A clear diagnosis of insomnia is very important for health assessment. The World Federation of Societies of Biological Psychiatry Working Group on Sleep Disorders has reached consensus on the value of physiological measurement tools and biomarkers in the diagnosis of insomnia. Based on this consensus, this paper interprets it in order to provide relevant help for clinical practice and scientific research.