This paper introduces the development and changes of clinical practice guidelines based on the enlightenment of the Reporting Items for Practice Guidelines in Health Care (RIGHT), and provides policy recommendations.
Surgical innovation is an important part of surgical research and practice. The evaluation of surgical innovation through the stages is similar to those for drug development, but with important differences. The Idea, Development, Exploration, Assessment, and Long-term follow-up (IDEAL) Framework and Recommendations represent a new paradigm for the evaluation of surgical intervention and devices which was developed in 2009. The IDEAL is a five-stage framework involving the nature stages of surgical innovation, together with recommendations for surgical research pathway. The Framework and Recommendations were updated and published in 2019, which added a pre-IDEAL stage if necessary. The updated IDEAL also underlines the purpose, key question and ethical issues for each stage. In the first paper of IDEAL Framework and Recommendations series, we conducted a comprehensive introduction of IDEAL (e.g. the development, updates and application of IDEAL) to promote the dissemination and application of IDEAL in China.
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.
IDEAL framework and recommendations provide a scientific and integrated evaluation pathway for surgical innovations and other complex therapeutic interventions, and underline that the preliminary studies are needed to prepare for a successful randomized controlled trial. IDEAL framework provides a series of recommendations in terms of nature stages of surgical innovation. We have reported the introduction and reporting guidelines of the IDEAL framework and recommendations in our IDEAL series paper. This paper aimed to provide some empirical evidence, focusing specifically on stages 2a and 2b, to help surgeons and researchers to understand how to imply IDEAL framework and recommendations into their clinical practice.
ObjectiveTo provide recommendations for the management of intensive care unit patients without novel coronavirus disease 2019 (COVID-19).MethodsWe set up a focus group urgently and identified five key clinical issues through discussion. Total 23 databases or websites including PubMed, National Guideline Clearing-House, Chinese Center for Disease Control and Prevention and so on were searched from construction of the library until February 28, 2020. After group discussion and collecting information, we used GRADE system to classify the evidence and give recommendations. Then we apply the recommendations to manage pediatric intensive care unit in the department of critical care medicine in our hospital. ResultsWe searched 13 321 articles and finally identified 21 liteteratures. We discussed twice, and five recommendations were proposed: (1) Patients should wear medical surgical masks; (2) Family members are not allowed to visit the ward and video visitation are used; (3) It doesn’t need to increase the frequency of environmental disinfection; (4) We should provide proper health education about the disease to non-medical staff (workers, cleaners); (5) Medical staff do not need wear protective clothing. We used these recommendations in intensive care unit management for 35 days and there was no novel coronavirus infection in patients, medical staff or non-medical staff. ConclusionThe use of evidence-based medicine for emergency recommendation is helpful for the scientific and efficient management of wards, and is also suitable for the management of general intensive care units in emergent public health events.
Adherence to reporting guidelines contributes to report methodology and outcomes of research distinctly and transparently. There are some checklists with specific study types related to surgery on the EQUATOR Network’s website. However, the IDEAL framework focuses on stepwise evaluation of surgical innovation through all stages with some key elements, which those existing guidelines may not mention. This likely results in the inaccuracy in reporting in studies attempting to follow the IDEAL recommendations and suggests a pressing need for IDEAL reporting guidelines. Considering these limitations, the IDEAL developed the IDEAL reporting guidelines between October 2018 and May 2019. The paper aimed to provide interpretation of IDEAL reporting guideline, and promote its understanding and use among Chinese researchers.
ObjectiveThe clinical trial evidence and expert consensus in the airway management were systematically summarized in this guideline to provide clinical guidance for healthcare professionals.MethodsA total of 40 clinical questions were proposed by 32 experts, and 12 clinical questions were finally identified through the Delphi method and the PICO (patient, intervention, control, outcome) principle from 2019 to 2020. PubMed, Web of Science, Wanfang database and CNKI were searched from establishment of each database up to November, 2020. The evidence of 160 articles was graded according to GRADE method, including 18 in class A, 36 in class B, 69 in class C, and 37 in class D. Four symposiums were organized for discussion of the recommendations. Finally, 23 recommendations were made for these 12 clinical questions, among which 10 were strongly recommended and 13 were weakly recommended.ResultsSmoking cessation for at least 4 weeks, pulmonary function assessment and pulmonary rehabilitation exercise were recommended in the perioperative period, especially at least 1 week of pulmonary rehabilitation exercise for the patients with high risk factors. Anesthesia was maintained by inhalation or intravenous anesthesia. It was recommended to choose short acting drugs, monitor the depth of anesthesia and muscle relaxation during operation, and use protective ventilation strategy. Postoperative use of drugs and mechanical measures to prevent venous thromboembolism, the appropriate application of drainage tube, preemptive analgesia and multimodal analgesia for pain management were recommended. Inhaled corticosteroids with bronchodilators could be used in perioperative period to reduce airway hyperresponsiveness and postoperative cough.ConclusionFor perioperative airway management, smoking cessation, pulmonary function assessment and pulmonary rehabilitation exercise are recommended in the perioperative period. The rational use of anesthetic drugs and protective ventilation strategy are emphasized during the operations. Postoperative pain management and cough treatment should be strengthened, and drainage tube should be used properly.
During the coronavirus disease 2019 (COVID-19) epidemics, universities take responsibility for the health of their students and epidemic control. Our urgent recommendation focuses on four key questions of emergency management in universities following rigorous evidence-based approaches and provides timely suggestions to university managers, academic faculties and student affairs managers. We recommend universities during the COVID-19 epidemics should: 1) suspend offline lectures; 2) provide proper health education on the disease; 3) encourage face masks, however oppose using N95 masks on the campus; 4) encourage hand hygiene and provide sanitizing products on the campus.
In the process of formation of recommendations of clinical practice guidelines, experts have many difficult problems of lack of transparency and high subjectivity in making final decisions, such as incomplete comprehensive consideration of dimensions and great heterogeneity in the evaluation of importance between dimensions, etc. As a decision-making tool, multi-criterion decision analysis improves the decision-making level of recommendation by adding the combination of qualitative and quantitative methods. By analyzing the challenges facing the formation of recommendations, this paper introduces the decision assistance of multi-criterion decision, and analyzes and summarizes the advantages and methods of the application of multi-criterion decision, so as to provide reference and guidance for guide makers to solve the difficulties in the formation of recommendations.
Evidence grading and recommendation strength assessment are key steps in the development of evidence-based guidelines, and have made significant progress in recent years. This article systematically reviews the development and evolution of evidence grading and recommendation strength in the past 30 years, and introduces the main representative standards. At the same time, a brief introduction is given to the guidelines and consensus evaluation results published in the field of neurological diseases in China, and future improvements are proposed. This article aims to help readers understand the development patterns of evidence grading and recommendation strength, in order to better understand the guidelines, and to develop more standardized guidelines.