National Center for Medical Service Administration of National Health and Family Planning Commission of China was established at the beginning of 2015. It is mainly in charge of developing and managing standards of medical technology and organizing their implementation, and giving technical guidance and consulting for evaluation of medical institutions. The foundation of the center fills in the blank of lacking central administrative department of the guideline development and evaluation. This paper introduces the definition and the function of clinical practice guideline, and analyzes the current situation, problems and challenges of domestic guidelines, and proposes some potential suggestions on improving the quality of Chinese guidelines from national level for promoting the standardization, scientification and transparency of clinical practice guidelines in China.
In response to the public health emergency and other urgent needs, World Health Organization (WHO) developed the concept and methodology of rapid advice guidelines (RAGs) in 2006. Compared with the standard guideline, striving to minimize the risk of bias, the RAG shortens the time to 1-3 months from more than 2 years. This study introduces the background, definition, application condition and performing methods of RAGs, and uses an example to clarify it, thus to provide a reference for the guideline development of public health emergency and other urgent need in China.
To introduce the definition, applicable scenarios, methodology and examples of mixed methods systematic reviews, aiming to promote the application of mixed methods in China and to help clinical decision-makers to select appropriate qualitative results from systematic reviews to guide clinical practice.
Mitral valve replacement is one of the most common heart valve surgeries in China. In recent years, with the increase in degenerative valve diseases, older patients, and the progress of anti-calcification technology of biological valves, the proportion of mitral valve biological valve replacement has been increasing year by year. After the damage of traditional mitral valve biological valves, re-operation of valve replacement with thoracotomy is required. However, the adhesion between the heart and sternum, as well as the damage caused by cardiopulmonary bypass and cardiac arrest, can cause significant trauma to elderly patients and those with multiple organ dysfunction, leading to increased mortality and complication rates. In recent years, interventional valve surgery, especially transcatheter valve-in-valve surgery, has developed rapidly. This procedure can correct the damaged mitral valve function without stopping the heart, but there are still many differences between its technical process and conventional aortic valve replacement surgery. Therefore, organizing and writing multicenter expert recommendations on the technical process of transcatheter valve-in-valve surgery for damaged mitral valve biological valves is of great significance for the training and promotion of this technology.
The Diabetic Foot and Peripheral Vascular Disease Study Group, Chinese Diabetes Society, released an expert advice Recommendations of Chinese Experts on the Standardized Diagnosis and Treatment of Diabetic Foot During Coronavirus Disease (COVID-19) Pandemic, and the International Diabetic Foot Care Group and D-Foot International released a document Fast-track Pathway for Diabetic Foot Ulceration During COVID-19 Crisis: A Document from International Diabetic Foot Care Group and D-Foot International during the 2020 outbreak, respectively. Both have the same goals, but the implementation focuses are different. The aim of this article is to give an interpretation of both expert advices in terms of the general principles, the epidemic prevention and control, the family, community and hospitalization management model of diabetic foot, the holistic principle of diabetic foot standardized management, and the telemedicine application in the late epidemic period.
在临床干预试验中，运用随机分配是对照试验中控制偏倚和混杂的最佳工具。研究人员必须确保在试验报告中包含读者所需要的信息，以判断结果的有效性及其意义。事实上，完整的试验报告可让临床医生改进他们的临床实践，以反映当前最佳证据，并改善患者临床终点。制定 CONSORT 声明可协助研究人员、作者、审稿人及编辑了解临床试验报告中所需的必要信息。CONSORT 声明适用于任何干预措施，包括草药产品。当前草药干预措施的对照试验未充分报告 CONSORT 建议的信息条目。我们希望最近制定的 CONSORT 建议条目扩展版能更准确地报告草药干预措施随机对照试验，使其更加完整。我们编写的这份解释性文件除概述了每项建议的理由外，还提供了 CONSORT 条目和相关详细说明，并为每项建议提供了良好报告和经验证据的范例，以帮助作者能更好地运用它们。随着越来越多的证据积累和反馈意见的收集，这些有关草药产品临床试验报告的建议可随时进行修订。
China has accumulated abundant experience on how to deal with post-disaster mental problem in recent years. However, the relevant concepts about post-disaster mental health services, detailed contents and process of the services were still incomplete. In order to provide guidance for the implementation of post-disaster mental health services, optimize service process, and improve service experience, the development of management practice of post-disaster mental health service is warranted. The authors give some suggestions on developing the management practice.
The Rapid Advice Guidelines (RAGs), prepared in the form of evidence-based guidelines for responding to public health emergencies in a short period, are characterized by their capability to significantly reduce the time for the development of guidelines to the maximum extent while ensuring quality. Therefore, the RAGs are primarily used to guide and respond to public health emergencies. This article will introduce the definition, characteristics, current situation, applicable situation, development methods, advantages and limitations of the RAGs. Our study proposes several suggestions for RAGs developers and researchers to improve development of RAGs in China.
The formation, evaluation and grade division of real-world evidence (RWE) are bottlenecks restricting the in-depth development and scientific application of real-world study methods. This paper briefly reviewed the design grade and evidence grade of clinical medical research, and proposed the key points of evidence grade of real-world clinical research, including emphasizing the comprehensive evaluation of internal authenticity and external authenticity, determining the "starting point" of real-world evidence, and using the real-world evidence quality evaluation method. Based on the internationally recognized "grading of recommendations assessment, development, and evaluation (GRADE)", combined with the classification and characteristics of real-world evidence, a preliminary grading scheme was formed. An example was given to illustrate the grading suggestion.