ObjectiveTo understand the current national status of the rating of published orthopedic guidelines and consensus in China, to help users select the appropriate use of these clinical guidelines, to guide clinical practice, and to promote the targeted improvement of the quality of Chinese orthopedic guidelines and consensus. MethodsChinese biomedical databases, including CNKI, WanFang Data, and SinoMed were searched electronically from January 2016 to October 2023, and relevant Chinese orthopedic clinical practice guidelines and consensus documents were collected. Two evaluators independently screened the retrieved literature and extracted data. The scientificity, transparency, and applicability rankings (STAR) tool was used to comprehensively rate Chinese orthopedic guidelines and consensus documents published in medical journals since 2016. Any dispute between the two evaluators was resolved by consulting a third evaluator. Kappa values were used to evaluate the consistency of the results between the two evaluators. ResultsA total of 191 orthopedic-related guidelines and consensus documents were obtained, including 74 guidelines and 117 consensus documents. The average score of the guidelines included in the evaluation was 34.4 points, while the average score of consensus documents included in the evaluation was 21.7 points. Guidelines scored higher than consensus documents in areas such as registration, planning, workgroups, clinical issues, evidence, consensus methods, recommendations, accessibility, and other fields. The Kappa value test result was 0.684. ConclusionThere has been a progressive increase in methodological scores of Chinese orthopedic clinical practice guidelines and consensus documents published in recent years, but the overall quality is not high. Future guidelines development needs to improve methodology further, especially in terms of transparent funding, formation of recommendations, guidelines release, and dissemination.
Maculopathy caused by various fundus diseases in the late stage is a common cause of low vision. Medical technology is difficult to reverse the loss of macular function currently, so interventions that help improve the visual system, utilize residual visual function, and improve quality of life deserve attention. Damage to the fovea of the macula does not mean that the entire retinal function is impaired. There may be one or more retinal regions adjacent to the fovea that can serve as a fixation center. It is possible to form stable paracentral fixation, complete functional remodeling of the visual system, and effectively utilize residual visual function by taking appropriate training on these potential paracentral fixation points for most patients. In 2021, a clinical guideline has been published for low vision rehabilitation in China. In order to strengthen the precise management of diseases and develop a standard operating procedure for visual training specifically for patients with low vision due to macular disease, the National Clinical Research Center for Eye Diseases initiated and organized relevant domestic experts, utilizing the latest research experience at home and abroad, and through repeated discussions, this consensus (International Practice Guideline Registration Number: PREPARE-2023CN199) was formed as a reference for ophthalmologists, optometrists and rehabilitation physicians in their clinical research and practice.
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.
ObjectiveTo evaluate the methodological quality of clinical practice guidelines and expert consensus of chronic heart failure domestically and abroad.MethodsPubMed, EMbase, SinoMed, CNKI, WanFang Data, and VIP databases, and related websites were searched to collect guidelines and expert consensus on chronic heart failure published from January 1st, 2011 to December 31st, 2020. Four reviewers evaluated the methodological quality of the guidelines and expert consensus with the AGREE Ⅱ tool after the consistency evaluation training.ResultsA total of 17 studies were included (consisting of 11 English and 6 Chinese studies). The recommended levels were B level (recommend after modification) for 10 studies and C level (not recommended) for 7 studies. The AGREE Ⅱ standardized mean scores for various fields were 69.61% (scope and purpose), 34.20% (stakeholder involvement), 33.13% (rigor of development), 84.53% (clarity and presentation), 42.40% (applicability), and 37.09% (editorial independence). The methodological quality of English guidelines was generally high (level B for 10 and level C for 1), while all scores of Chinese guidelines or consensus in the 6 fields were mostly lower than the average (level C for 6).ConclusionsThe guidelines for the diagnosis and treatment of chronic heart failure requires further improvement in terms of stakeholder involvement and rigor of development. It should develop standards and methods to improve the quality for Chinese guidelines and expert consensus to better serve clinical practice.
The high incidence of hydatid disease in seven northwestern provinces, is one of the reason of "Poverty due to illness, and return poverty due to illness" in China. The incidence of chest hydatid disease in China after hepatic hydatid disease ranks second. Department of thoracic surgery in the First Affiliated Hospital of Xinjiang Medical University is on the domestic leading position of the treatment of chest hydatid disease. Since 1956 the first case of pulmonary hydatid cyst were completed, we have successfully finished the surgical treatment of pediatric chest hydatid disease, chest hydatid disease complex, huge pulmonary hydatid cyst, mediastinal and pleural hydatid cyst, and rib hydatid in our department. To further standardize the treatment of chest hydatid disease, a special formulation of "technical specification for chest hydatid disease diagnosis expert consensus" by our department were produced, in order to help clinicians treat chest hydatid disease by more suitable strategies. This consensus was released in July 2015, for the original version. The definition, diagnosis, treatment principle, and prevention of chest hydatid disease were elaborated and clinical experiences of 60 years were combined with in this consensus, in order to help the clinicians for diagnosis, treatment, and prevention of hydatid disease.
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.
Anti-tumor necrosis factor-α monoclonal antibody agents have been widely applied in the management of autoimmune diseases. Among them, Adalimumab and Infliximab have been used for years in clinical practice in treating non-infectious uveitis and achieved satisfactory effects and safety. However, no guideline or expert consensus for their usage is available in China currently. It hopefully promotes standardized clinical application of anti-tumor necrosis factor -α monoclonal antibody in treating non-infectious uveitis, together with other senior experts in uveitis, the Ocular Immunology Group of Immunology and Rheumatology Academy in Cross-Straits Medicine Exchange Association form this evidence-based recommendations for clinicians’ reference.
Clinical trials are the most reliable means for scientifically rigorous evaluation of the efficacy and safety of drugs, and are the most crucial part receiving the most investment in development and innovation in the pharmaceutical industry. In recent years, the nation has formulated a set of policies and guiding principles to encourage pharmaceutical innovation, promote the independent innovation of China’s pharmaceutical industry and enhance clinical trial capacity. To further improve Chinese researchers’ ability to perform clinical trials, the National Clinical Research Center for Cardiovascular Diseases, Fuwai Hospital, Chinese Academy of Medical Sciences and the National Center for Cardiovascular Diseases invited a multi-disciplinary team of experts from various areas including clinical trial methodology and supervision to work on this consensus. In view of the common concern and puzzles regarding the issues in clinical trials, such as recruitment and retention of participants, outcome selection, quality control, information technology application, and ethics in data security, the expert consensus is based on domestic and international guidelines, the latest advancement of clinical research, and the advice and opinions from national experts. It aims to provide reference information and guidance for clinical trial researchers, and serves as a reference for relevant authorities to formulate clinical trial management policies.
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.