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.
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.
Pneumoconiosis is the most harmful and common occupational disease in China. The development of a pneumoconiosis rehabilitation expert consensus can improve utilization of the unique advantages of Chinese and Western medicine rehabilitation strategies, and provide effective and feasible guidance for the clinical rehabilitation of pneumoconiosis. We conducted clinical problem investigation, evidence collection and evaluation, Delphi consultation, and other technical links following the WHO guidelines to formulate manual procedures. Relevant rehabilitation guidelines, systematic reviews, clinical researches, and other current best evidence and expert opinions were extensively solicited to formulate the consensus. The reporting of consensus followed the RIGHT statement. The 14 types of rehabilitation strategies recommended by this consensus can be used by clinical rehabilitation physicians, rehabilitation therapists, respiratory therapists, nursing staff, community rehabilitation, health education, and other professionals for the rehabilitation of pneumoconiosis patients.
Clinical practice guidelines need to be based on evidence, but traditional Chinese medicine, especially integration of traditional Chinese and Western medicine guidelines, inevitably need to combine clinical research evidence, ancient literature, and expert experience and consensus. In the process of formulating, there are deviations in understanding and application of the expert consensus method and expert experience, resulting in opaque of the recommendations, unclear of the details of the diagnosis and treatment strategy, less prominent of the advantages and value of traditional Chinese medicine, which affects the scientificity, transparency, applicability, promotion and application of the guidelines of traditional Chinese medicine or integration of traditional Chinese and Western medicine. This study discusses the guiding principle of "evidence as a core, consensus as a supplement, and experience as a reference" that was generally followed and puts forward detailed methodological suggestions to the formulation of guidelines for traditional Chinese medicine and integration of traditional Chinese and Western medicine.
With the continuous aging of the population in China, the aging of skeletal muscle in the elderly has seriously affected national health and poses a severe challenge to the public health system. Early detection of skeletal muscle aging, and early warning, prevention, and treatment are of great significance for achieving healthy aging. In order to select a series of clinically operable biomarkers for skeletal muscle aging, and to further standardize the early identification and precise diagnosis of skeletal muscle aging, a multidisciplinary team of experts has registered and written this protocol to provide a detailed introduction to the planning process for the development of the consensus.
In the context of the rapid development of contemporary medical industry and the unbalanced development of various subspecialties, expert consensus plays an extremely important role in guiding clinical practice and improving the quality of medical care. However, there are some deficiencies and limitations in the formation process and final report of the expert consensus. Therefore, this paper summarizes and reviews the definition, applications, and functions of expert consensus and the new progress of expert consensus formation methods by fully reviewing the literature, and puts forward the prospect. The purpose is to provide a reference for the production and application of expert consensus related to medical care, improve the outcomes of medical care, and upgrade the quality and level of medical services.
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.
Families are important venues for nutritional management of the elderly, and there is an increasing demand for continuous nutritional management services from hospital to home. It has been 7 years since the publication of the "Chinese expert consensus on home nutrition administration for the elderly (2017 edition)", and with the publication of more research evidence and the practice of home nutrition administration, there is an urgent need to update the 2017 edition of the consensus. A total of 35 recommendations or consensus opinions have been proposed in this consensus update, aiming to guide grassroots related professionals to provide scientific, reasonable and standardized home nutrition management services for the elderly population at home or in the community.
ObjectiveTo compare the recommended medicines of cardiovascular and cerebrovascular diseases guidelines, expert consensus, or diagnosis and treatment specifications with essential medicines from the 2023 World Health Organization Model List of Essential Medicines (WHO-EML) and the 2018 National Essential Medicine List (NEML) in differences and similarities. MethodsSix guideline websites and one association website including Guidelines International Network and National Guideline Clearinghouse, etc. were searched from inception to July 2023. The latest cardiovascular and cerebrovascular diseases guidelines, expert consensus, diagnosis and treatment specifications involving medicine treatment were included, and we extracted the data (year, title, target disease, authors and recommended medicines), and the statistical analysis of recommended medicines included in the WHO-EML and NEML was performed by Excel 2016. ResultsA total of 83 guidelines, expert consensus, and diagnosis and treatment specifications were included, covering cerebrovascular diseases, ischemic heart diseases, hypertensive diseases, chronic rheumatic heart diseases, diseases of arteries, arterioles and capillaries and other unspecified circulatory system disorders. They were issued from 2002 to 2023. Fifty-five (66.3%) were published in the past 5 years. For the 246 recommended medicines, they were divided into 14 categories according to the pharmacological effect. 27.2% (67/246) were included in WHO-EML and 32.9% (81/246) were included in NEML, among which 41 medicines were included both in WHO-EML and NEML, 40 in NEML only, 26 in WHO-EML only, and 139 in neither. The number of excluded medicines in antihypertensive medicines, lipid-regulating medicines and antiatherosclerotic medicines and anticoagulants exceeded 10. ConclusionThe number of cardiovascular and cerebrovascular disease guidelines, expert consensus, and diagnosis and treatment specifications recommended for WHO-EML and NEML is lower than 50%, and the coverage rate of NEML for cardiovascular and cerebrovascular disease guidelines recommended treatment medicines is higher than that of WHO-EML.
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.