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.
By employing the nominal group technique, as per the process standard of the EQUATOR Collaboration Network, experts were selected through purposeful sampling. Two rounds of nominal group discussions were conducted, and the essential information of the utilization of the consensus method was extracted from the literature. After comparison, discussion, evaluation, and optimization, a list of 3 fields, 11 themes, 63 necessary items, and 28 supplementary items was eventually constructed to upgrade the standardization and rigor of the application of the consensus method in the future, assisting guideline developers to plan the consensus process.
With the rapid development of fundus imaging technology, it is of great significance to establish a new naming system for neovascular age-related macular degeneration (nAMD) based on the multi-mode imaging. In 2020, an international panel of retina specialists, imaging and image reading center experts, and ocular pathologists reached a consensus after repeated discussions, a new name for nAMD subtype and related lesions was established based on the previous knowledge of fundus fluorescein angiography and pathology, combining indocyanine green angiography, optical coherence tomography and optical coherence tomography angiography with current pathological knowledge, in order to help ophthalmologists to study nAMD. The consensus proposed the term "macular neovascularization" and classified it into type 1, type 2 and type 3. Many lesions related to macular neovascularization, such as pigment epithelial detachment, hemorrhage, fibrosis, rip of retinal pigment epithelium and so on, were named. The new designation will help improve clinical communication between different studies, establish standard definitions and terms between reading centers and researchers, and further promote the understanding and communication of nAMD among ophthalmologists.
Inherited retinal diseases (IRDs) are a group of severe retinal degenerative diseases leading to permanent visual impairment. IRDs are the major cause of irreversible blindness in children and working age groups. Gene therapy is a new clinical treatment method and currently the only clear and effective treatment for IRDs, while, there are still risks in clinical research and application. How to standardize perioperative management and reduce the potential risks of treatment is one of the keys to ensure the safety and effectiveness of treatment. However, there is no systematic and standardized guidance on the perioperative management for IRDs gene therapy. Therefore, in order to standardize the perioperative management, the Fundus Disease Group of Ophthalmology Society of Chinese Medical Association and Chinese Medical Doctor Association organized domestic experts to put forward standardized opinions on the perioperative management of IRDs gene therapy in China after repeated discussion and combined with domestic and foreign research experience, so as to provide clinicians with reference and application in clinical research and practice.
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.
Massive cerebral infarction with malignant brain edema has poor prognosis with very high mortality, despite aggressive medical treatment. Surgical decompression is recommended by Chinese and international clinical guidelines for patients with massive cerebral infarction, however, there is no standardized diagnosis and treatment protocol in clinical practice. Following the principle of evidence-based medicine and based on the diagnosis and treatment norms of the participating hospitals of Severe Ischaemic Stroke Collaboration in recent years, we recommend this consensus statement of the standardized surgical decompression for malignant brain edema in massive cerebral infarction.
Objectives To assess the quality of clinical practice guidelines for primary hepatic carcinoma published in 2016 and 2017 in China. Methods CNKI, WanFang Data, CBM and VIP databases were searched for clinical practice guidelines for primary hepatic carcinoma in China. The search date was from Jan. 1st, 2016 to Jan. 1st, 2018. Four researchers independently selected literatures and extracted data according to the inclusion and exclusion criteria. The Appraisal of Guidelines for Research and Evaluation Ⅱ (AGREE Ⅱ) was utilized to assess the methodological quality of the guidelines. Results A total of 7 guidelines were included. The average scores of six domains for these guidelines were: 65.1% for scope and purpose, 39.4% for stakeholders’ involvement, 64.3% for rigor of development, 55.6% for clarity of presentation, 61.8% for applicability and 6.1% for editorial independence. Conclusions The quality of clinical practice guidelines for primary hepatic carcinoma in China is relative high, of which the recommendations are of great value in clinical practice, yet still required to be improved in some ways.
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.
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.
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.