Objective The purpose of the extension of the RIGHT statement for introductions and interpretations of clinical practice guidelines (RIGHT for INT) was to promote the development of comprehensive and clear article those introduced and interpreted clinical practice guidelines. MethodsThe RIGHT for INT checklist was developed following methods recommended by the EQUATOR Network. The development process included three stages. In the first stage, a multidisciplinary team of experts was recruited by email and WeChat and further divided into three groups (a steering group, a consensus group, and a secretariat group); in the second stage, the initial items were collected by literature review and brainstorming; and in the third stage, the final items were formed through a Delphi survey and expert consultation. ResultsA total of 40 initial items were collected through literature review and brainstorming. A final checklist of 27 items was formed after the Delphi survey and expert consultation. ConclusionThe RIGHT for INT checklist provides guidance for guideline interpreters on how to introduce and interpret clinical practice guidelines in a scientific and comprehensive manner.
Objective The ultimate goal of developing guidelines is for using them in clinical practice. In this study, an implementation evaluation tool was developed to promote the overall evaluation of guidelines and to improve their promotion and implementation. Methods The research group set up a team to formulate and establish a guideline implementation evaluation tool, through preliminary research, interviews, a systematic review of relevant literature, two expert consensus meetings and two Delphi expert consensus meetings to evaluate the guideline implementation tool. Experts were invited to give opinions and grades on the fields, items and overall implementation evaluation method of the tool. Results The evaluation tool for the implementation of guidelines included 5 fields, accessibility, communicability, performability, recognizability and applicability, with a total of 7 items. The scale-level CVIs in two rounds of Delphi expert consensus were 0.91 and 0.93. We collected opinions and suggestions and made some revisions and insertions without deleting any items based on the parameter that no items fulfilled the standard if mean <3.5, coefficient of variation >15% and I-CVI<0.78. Conclusion In this study, in order to provide a standard and method for the evaluation of guideline implementation, a guideline implementation evaluation tool has been developed and evaluated by clinically-related physicians and guideline formulation methodology experts. The guideline implementation evaluation tool presents satisfactory face and content validity. Empirical research is needed to verify the tool’s performance in evaluating guideline implementation.
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.
1992年,循证医学(evidence-based medicine,EBM)倡导者提出新"范式",即卫生研究证据是对个体病人及卫生系统决策的最好基础.该方法原意是拟除去传统医学知识体系仅关注疾病本身的病理生理过程及临床经验的积累,因此在2001年被lt;纽约时代杂志gt;评为最具影响力的理论之一.本文回顾了循证医学的产生、发展、哲学局限性和临床实践的挑战.指出EBM的演变、发展早已超出它原来(误解的)概念,即EBM有可能替代传统医学.EBM现正力求去增强而不是替代个人的临床经验及了解疾病的机制.并且EBM一定要继续发展、并探讨一系列的问题包括加强科学基础,伦理道德的重要性及其有关传播及应用的实际事务.例如,为了促进科学研究成果用于临床,证据往往都是从经选择过的人群的不完整证据而来,这些人群仅能从那些贵重技术中得到一些边缘性的好处.而证据的应用就会把这些有限的好处普遍化,由此引发出一系列问题即有多少人和谁能用得起这些新的疗法.因此循证医学的倡导者希望医生及用户关注那些来自临床研究、有效且适于临床应用的好证据.而要达到此目标还需做很多的工作.
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 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.
ObjectiveThe application of the coefficient of variation (CV) in the development of clinical practice guidelines is limited to evaluating the consistency of the consensus panel in clinical questions rating, and the application of variability was limited. This study presents the application and results of variability evaluation in the development of guidelines. MethodsWe conducted a large-scale clinical survey through questionnaire survey, and conducted two rounds of questionnaire survey and face-to-face consensus meeting for the consensus group. Means and CV were calculated for clinical questions and outcome importance ratings. We performed the summary and analysis by SPSS and Microsoft Excel. ResultsA total of 356 clinical survey questionnaires and two rounds survey in consensus panel were collected. We found that in the clinical survey and the first-round of the consensus panel, the CV was greater than 25% for all clinical questions regardless of the overall importance score. In the consensus panel, the results of the second-round were greatly changed. On the one hand, compared with the first-round, the CV of almost all clinical questions was smaller in the second-round, and the CV of high-priority clinical questions was less than 25%, while the clinical questions with a CV greater than 25% were of low-priority. In view of the CV of outcome importance, the clinical survey was similar to the results of the first-round of consensus panel. The CV of very important outcomes was less than 30%. In the second-round of consensus panel, the variability of very important outcomes was less than 20%. The higher the importance level of the outcome was, the smaller the CV was. ConclusionThe study of variability evaluation has practical methodological value, which can assist clinical questions and outcomes priority selection, and help to fully consider the influence of different factors and values, and develop high-quality guidelines.
Community-acquired pneumonia refers to infectious pulmonary parenchyma inflammation that occurs outside the hospital, including pneumonia that occurs during the incubation period after admission of pathogens with a clear incubation period. Community-acquired pneumonia has a high incidence and mortality rate, imposing a heavy medical burden and posing a serious threat to social public health. In the diagnosis and treatment of community-acquired pneumonia, traditional Chinese medicine and Western medicine each have their own advantages. In order to strengthen the diagnosis and treatment of community-acquired pneumonia through the integration of traditional Chinese and Western medicine, and improve the prevention and treatment level of community-acquired lung disease, this guideline was developed by the Internal Medicine Professional Committee of the World Federation of Chinese Medicine Societies, led by Henan University of Chinese Medicine and the First Affiliated Hospital of Henan University of Chinese Medicine. This guideline refers to the development methods and processes of international clinical practice guidelines, based on the best existing evidence, combined with the characteristics of integrated traditional Chinese and Western medicine in the treatment of community-acquired pneumonia, weighing the pros and cons of intervention measures, and finally forming six recommended opinions, in order to provide references for the clinical practice of integrated traditional Chinese and Western medicine in the treatment of community-acquired pneumonia.