With the advancement of research on rare ocular diseases such as inherited retinal dystrophy (IRD) has advanced in recent years, especially breakthroughs in therapeutic approaches represented by cell and gene therapy, potential intervention strategies have emerged for these conditions. Establishing standardized endpoints and evaluation methods for visual function in patients with IRD has become crucial for assessing disease progression, safety, and therapeutic efficacy of innovative treatments. Best corrected visual acuity (BCVA) is widely recognized as one of the primary endpoints for assessing visual function. However, for IRD patients with severe rod photoreceptor dysfunction, who often present with profound low vision or even legal blindness, the applicability of BCVA as a traditional visual function indicator is limited. The multi-luminance mobility test (MLMT) has emerged as a functional visual assessment tool that evaluates the ability to navigate obstacle courses under varying illumination levels. By establishing graded evaluation standards, MLMT objectively quantifies the impact of lighting conditions on patients’ nobility and spatial orientation, providing a novel quantitative tool for assessing visual function in IRD clinical trials. Currently, there is a lack of unified and standardized guidelines for the use of MLMT in China, posing challenges to its implementation in practical clinical research. To address this, Ocular Fundus Disease Society of Chinese Medical Association and Chinese Medical Doctor Association convened a multidisciplinary team comprising clinical experts in genetic retinal diseases, statisticians, and optical specialists to investigate the current applications and technical characteristics of MLMT, ultimately formulating consensus recommendations for its use as a clinical trial endpoint for IRD gene therapies. This consensus aims to provide a set of MLMT operating norms applicable to China's national conditions, guide clinical practice and research in ophthalmology and related disciplines, and promote the standardization process of IRD clinical trials in China, so as to better serve the IRD patient population and promote the development of related fields.
Objective To form the list of methodological quality evaluation and explanation for the selection of objective performance criteria in single arm trial, and initially construct a methodological guiding tool for the selection and evaluation of target value, so as far to provide a research basis for improving the system of single-arm trial quality evaluation by objective performance criteria method. Methods Combining the bias risk assessment method of observational study, interventional trails, domestic and foreign policy documents, and systematically collecting the common bias and evaluation key points, preliminarily proposing the list of methodological quality evaluation and explanation for the selection of objective performance criteria in single-arm trial, via two rounds of expert consensus voting using nominal group method, finally formulating the list based on the voting results and expert opinions. Results Through two rounds of discussion, sorting, comprehensive expert opinions, we improved the corresponding items in the list and finally formed the list of methodological quality evaluation and explanation for the selection of objective performance criteria in single-arm trial, which included four areas: authority, traceability, comparability, and reliability, including 10 items. The entries in each field considered both design and implementation throughout the clinical trial. Conclusion The methodology list developed in this study provides methodological guidance for the selection of objective performance criteria and quality evaluation, and provides a solid theoretical basis for the establishment of a complete methodological system of quality evaluation for objective performance criteria single arm trails.
Female pelvic floor dysfunction (PFD) is a common disease affecting women's quality of life, especially in older women. The establishment and application of multimodal evaluation system is the key to the accurate diagnosis and effective treatment of PFD. The purpose of this expert consensus is to provide a comprehensive, multi-layered assessment framework that includes clinical examinations, imaging examinations, biomechanical tests, and questionnaires to comprehensively assess pelvic floor function in women. By integrating different assessment methods, we aim to improve the early identification and diagnostic accuracy of PFD, so that personalized treatment can be developed to improve patient outcomes. The consensus also discusses the advantages and disadvantages of various assessment techniques and suggests directions for future research and clinical applications.
COVID-19 has been an established and continuing health problem. For the first time, this consensus focused on multi-scenario populations in the home/community, hospitalization and rehabilitation periods, and addressed medical nutrition management issues on which no consensus had yet been reached. This consensus was formulated on the basis of a comprehensive review of the existing evidence combined with the opinions of experts, with a view to complementing the existing guidelines/consensus.
Diabetic retinopathy is one of the microvascular complications of diabetes and a major cause of blindness in adults. Early screening is an effective way to reduce blindness caused by diabetic retinopathy. The diabetic retinopathy is one of the chronic retinal diseases highlighted in the “14th Five-Year” National Eye Health Plan (2021-2025). The establishment of effective and practical community screening model is a powerful guarantee to complete early screening. It is of great significance to standardize screening methods, screening personnel duties, equipment allocation, referral conditions and screening sustainability. Chinese fundus disease and related field experts developed the consensus through a serious, comprehensive, and complete discussion, to provide more reference for establishing a suitable community screening model of diabetic retinopathy and increasing the screening rate of diabetic retinopathy.
ObjectiveTo systematically investigate the current status of reporting health economics evidence in clinical practice guidelines and expert consensuses published in China from 2021 to 2023, providing references for the formulation and revision of guidelines and consensuses in our country. MethodsComputer searches were conducted in the CNKI, CBM, WanFang Data, China Academic Journals Full-text Database, PubMed, and Web of Science to collect clinical practice guidelines and expert consensuses published in China from 2021 to 2023. Two researchers independently screened the literature, extracted information on the inclusion of economic evidence in guidelines and consensuses, and then used quantitative analysis methods for description. ResultsA total of 4 236 relevant articles were included, of which 1 066 (25.17%) reported health economics evidence; 120 (11.26%) reported health economics evidence in the formation of recommendation opinions; 109 (10.23%) reported health economics evidence in the grading of evidence quality; 832 (78.05%) reported health economics evidence in the interpretation and explanation of recommendation opinions. ConclusionThe reporting rate of health economics evidence in clinical practice guidelines and expert consensuses published in China is not high. The reporting rate of health economics evidence in consensuses is lower than that in guidelines. It is recommended that during the formulation process of guidelines and consensuses, the application of health economics evidence should be further strengthened in aspects such as the formation of recommendation opinions, the grading of evidence quality, and the interpretation and explanation of recommendation opinions, in order to improve the scientific, rigorous, and applicability of clinical practice guidelines and expert consensuses, and to play the role of guidelines and consensuses in optimizing the allocation of health resources, improving clinical diagnosis and treatment effects, and enhancing the quality of medical care.
Acute pharyngitis belongs to the category of "acute throat impediment" in traditional Chinese medicine (TCM), which has a high incidence and is easy to recur. In clinical practice of TCM, Chinese patent medicines with the effects of clearing heat and detoxifying, reducing swelling and relieving pain are widely used in the treatment of acute pharyngitis. These medicines have the advantages of definite efficacy, low side effects, and low risk of developing drug resistance. However, at present, there are no standardized clinical diagnostic and therapeutic evaluation norms for acute pharyngitis in TCM, which has hindered the application of TCM in the prevention and treatment of acute pharyngitis and the development of new TCM preparations. Therefore, the China Association of Chinese Medicine initiated this expert consensus, which was led the formulation by Xiyuan Hospital, China Academy of Chinese Medical Sciences. This expert consensus integrates the current best evidence and extensive clinical expert experience from the front line, covering seven aspects: applicable scope, diagnosis in both Chinese and Western medicine, syndrome classification and evaluation scales, basis for efficacy evaluation, and time for efficacy evaluation. It has formed 8 types of TCM syndromes for acute pharyngitis, as well as the diagnostic criteria, syndrome classification and evaluation scales, evaluation basis for efficacy, and scoring standards for syndromes and diseases. This expert consensus can be used to standardize the diagnosis of the TCM syndromes of acute pharyngitis, as well as the core indicators and evaluation methods for syndrome and disease efficacy, with the aim of providing references for clinical practice and scientific research on acute pharyngitis.
Objective To explore the methodological characteristics of Chinese clinical practice guidelines/expert consensus based on usage of GRADE. MethodsCNKI, PubMed, WanFang Data databases, and Medlive.cn were electronically searched to collect Chinese clinical practice guidelines/expert consensus over the past 11 years from January 1st 2010 to December 31st 2020. Four reviewers independently extracted data according to the content of appraisal of guidelines quality evaluation tool AGREE Ⅱ. The clinical practice guidelines/expert consensus were divided into two groups based on whether GRADE was used or not. The changes and development of methodological quality in the past 11 years were explored between the two groups. ResultsIn recent years, the number of clinical practice guidelines/expert consensus which used the GRADE in China had increased annually. The practice guidelines/expert consensus which did not use GRADE had lower methodology quality (P<0.01). ConclusionsThe use of GRADE in clinical practice guidelines/expert consensus requires improvement, and mastering GRADE methodology can effectively improve the methodological quality of the clinical practice guidelines/expert consensus.
Intravitreal drug injection is a treatment for common chronic fundus diseases such as age-related macular degeneration and diabetic retinopathy. The “14th Five-Year” National Eye Health Plan (2021-2025) recommends focusing on fundus diseases and improve the management mode of patients with chronic eye diseases. Therefore, it is imperative to explore how to further optimize the service process of intravitreal injection under the premise of guaranteeing patients' medical safety, to promote medical service efficiency and standardized management level and improve the medical experience of patients. Based on the quality control standard of vitreous cavity injection for retinopathy in China, Chinese fundus disease and related field experts developed the present expert consensus on the establishment of a one-stop intravitreal injection model and the management of its organization after a serious, comprehensive, and complete discussion, focusing on a standardized operation process, quality control, and safety management, providing more references for establishing a suitable intravitreal injection management model for ophthalmology and promoting the development of diagnostic and treatment models for fundus disease in China.
As a new treatment option after conventional corticosteroids and immunomodulatory drugs, biologics have been widely used in the clinical management of non-infectious uveitis in many countries due to their approved efficacy and safety. Anti-tumor necrosis factor-alpha monoclonal antibody is the most commonly used one. However, the guidance on its standardized application is lacking. The Ocular Immunology Group of Immunology and Rheumatology Academy in Cross-Straits Medicine Exchange Association compiled the Chinese expert consensus on treatment of non-infectious uveitis with anti-tumor necrosis factor-alpha monoclonal antibody. This evidence-based consensus is made according to the principle of consensus building and combines the clinical experience of the experts. Twelve recommendations are formatted on the application of Adalimumab and Infliximab. The interpretation of this consensus point will help improve the normative and effective application of anti-tumor necrosis factor-alpha monoclonal antibody in ophthalmologists, rheumatologists and immunologists.
