Gordon Henry Guyatt(1953-)is a professor of Department of Clinical Epidemiology amp; Biostatistics and Department of Medicine in McMaster University. He has engaged in evidence-based clinical research and practice for about 20 years. In 1992, he first proposed the term “evidence-based medicine” in one of his articles published in JAMA. He is dedicated to bringing the wonderful idea of evidence-based medicine to bedside and systematically training clinicians from all over the world to acquire the basic skills for evidence-based clinical practice. His great contribution to evidence-based medicine is introduced in this article through demonstrating the development of evidence-based clinical practice.
理论上,临床实践与临床对照试验的方法相互不断影响.恰当的试验设计应该能反映医生和病人的想法,反之,熟悉临床试验可以改进日常临床实践的方法.换句话说,每一种方法学的原则都源于临床实践.例如:随机化(带有建设性地怀疑是否形成真正的对照),独立性(对药品公司善意的不信任),知情同意(与患者共同分担不确定性),Ⅰ型错误(对单个试验不要错误地乐观),Ⅱ型错误(对单个试验不要错误地悲观),选择正确的判效指标(相关性比精确性重要),意向性治疗原则(重实效的分析)以及亚组分析的危险["我的前一个患者综合征"(the my-last-patient syndrome)].
Objective To assess the methodological quality of clinical guidelines and consensus of lupus nephritis, to collect the recommendations of each guideline, and to provide references for clinical decision-making. Methods PubMed, CNKI, and CBM databases and related websites such as NGC, NICE, GIN, SIGN, and Medive were electronically searched from January 2012 to December 2020 to collect the clinical guidelines and expert consensus for lupus nephritis. After consistency evaluation by four evaluators, the methodological quality of the included guidelines or expert consensus was evaluated using AGREE Ⅱ. The relevant recommendations, evidence level, and recommended strength of each guideline in treating lupus nephritis were summarized. Results A total of eight guidelines and two consensus statements were included. Among them, eight guidelines or consensus statements were level B (generally recommended guidelines), and two were level C (non-recommended guidelines). Relevant recommendations mainly gave the corresponding treatment scheme according to the pathological type of lupus nephritis. Conclusion The methodological quality of lupus nephritis guideline formulation in China needs to be improved. The included guidelines and consensus can provide reference for clinical decision-makers. However, higher-quality clinical practice guidelines for the Chinese population are needed to be developed in the future.
Patient values and preferences is one of the elements of evidence-based medicine research, which is also an important part that should be considered in the development of evidence-based guidelines in the present and future. However, the research in this field in China has just begun. This article gives a brief introduction of its concepts, methods, influence factors based on the international researches of patient values and preferences and a brief description of the development in China, in order to provide references for the development of evidence-based guidelines based on the consideration of patient values and preferences in the future.
Objective To systematically review the requirements of patient participation in clinical practice guidelines (CPGs) in Chinese and foreign guideline development manuals. Methods Thirty-six authoritative society websites and guideline databases and 5 commonly used databases were searched online. Relevant information on patients’ participation in the guideline manuals was collected, summarized, and analyzed. Results A total of 37 manuals (33 foreign and 4 Chinese) were included. The requirements for the number of patients, the right to speak, status equality, and the right to vote in the guideline development manual accounted for 35.1%, 13.5%, 8.1%, and 5.4%, respectively. The requirements for participants’ mode of participation were not mentioned in the guideline development manuals from 2000 to 2010. There were 6 (16.2%) in 2011–2015 and 12 (32.4%) in 2016–2022. The comprehensive guidelines for multiple disease types accounted for 35.7%, 28.6%, and 57.1%, respectively, in terms of requirements for participants’ knowledge or experience, management of specialized personnel, and training support. The specific guidelines for a certain type of disease or drug accounted for 21.7%, 4.3%, and 17.4%, respectively; fifteen (40.5%) guideline development manuals mentioned the specific collection forms of patients’ values and preferences in guideline development. Conclusion Given changes to medical models and the emphasis on patients’ rights and interests, an increasing number of manuals have proposed requirements that consider the expression of patients’ values and preferences in manual development, and the dimensions of manual development are constantly enriched. However, manuals outlining the requirements of patient participation are still not comprehensive and can continue to improve.
Objective To assess the effectiveness of the course of “Being a Friend with Patients”. Methods There were three parts in this course: (1) To experience what the empathy was, by counseling activities; (2) To accompany patients in hospital; (3) To share the experience after accompanying. There were 118 participants who were freshmen at the end of 2005. Results and Conclusions According to feedback from the students, they understand empathy and how the patients feel after the counseling. The course is accepted by all students. It may help students to be more attentive to and concerned about their patients, and to provied help for them.
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.
本文是GRADE（Grading of Recommendations Assessment，Development，and Evaluation）系列文章的导论。该系列文章为使用GRADE系统提供指导，介绍如何将该系统用于系统评价、卫生技术评估（HTAs）及临床实践指南中备选方案的证据质量评价和推荐强度评级。GRADE方法始于提出一个明晰的问题，包括对所有重要结果的详细说明。证据被收集和汇总后，GRADE提供了明确的标准来评价其质量，包括研究设计、偏倚风险、不精确性、不一致性、间接性及效应量大小。