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.
The pre-market approval and clinical application of innovative medical devices should be based on high-quality evidence, proving their reliability, safety and effectiveness. In 2016, the IDEAL (Idea, Development, Exploration, Assessment and Long-term follow-up) collaboration modified the original IDEAL framework and recommendation to the IDEAL-D methodological framework for the entire life cycle evaluation of innovative medical devices. The framework included five stages, namely the preclinical development stage, idea stage, exploration stage, assessment stage and long-term follow-up stage. This paper aims to interpret the study purpose, content and design at each step of the IDEAL-D framework based on IDEAL framework and recommendation (2019) to provide practical methodological guidance for the design and conduct of clinical research on innovative medical devices.
ObjectiveTo systematically review the researches on grading criteria for quality of evidence and strength of recommendations of traditional Chinese medicine (TCM). MethodsPubMed, EMbase, Web of Science, CNKI, WanFang Data and VIP databases were electronically searched to collect researches on grading criteria for quality of evidence and strength of recommendations of traditional Chinese medicine from inception to June 2021. Two reviewers independently screened literature, extracted data; and then, descriptive analysis was performed using qualitative methods. ResultsA total of 18 studies were included. Specifically, 8 studies presented both the level of evidence and the strength of recommendations, 9 presented the level of evidence, and 1 presented the strength of recommendations. Thirteen studies considered both TCM evidence and modern medical evidence sources, 3 included only evidence from ancient literature, 1 focused only on post-marketing safety evaluation of Chinese medicine, and 1 focused only on real-world studies of TCM. ConclusionCurrently, there are numerous criteria for TCM related quality of evidence and strength of recommendations, and some are developed only for TCM characteristic evidence. Most researchers of TCM guidelines expect to fully value the significance of ancient literature and expert experience or opinion in guideline development.
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.
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.
Lung cancer is the highest morbidity of malignant tumor in China, and bone metastasis is one of the common sites. With the development of imaging and nuclear medicine technology, the level of early diagnosis of bone metastasis has been improved. There are also many evidence-based evidences and advances in systemic therapy (chemotherapy, targeted therapy, immunotherapy) and bone modification drugs for treatment of bone metastases from lung cancer. The comprehensive treatment model under the guidance of multiple disciplines (including medical oncology, surgery, radiotherapy, interventional medicine, nuclear medicine, psychological rehabilitation, etc.) has been widely implemented in clinical practice. Therefore, Lung Cancer Medical Education Committee of China Medicine Education Association, Youth Specialists Committee of Lung Cancer, Beijing Medical Award Foundation and Lung Cancer Specialty Committee of Chinese Elderly Health Care Association have written the "Chinese Clinical Guidelines on Diagnosis and Treatment of Lung Cancer Bone Metastasis (Version 2024)", based on the "Expert Consensus on Diagnosis and Treatment of Lung Cancer Bone Metastasis (Version 2019)". The aim is to enhance the comprehensive treatment level of lung cancer bone metastasis in China.
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.
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.
Given the severe situation of coronavirus disease (COVID-19), the elderly, especially elderly patients with chronic diseases are the key populations for prevention and control. We developed recommendations of daily diets for elderly and the elderly patients with chronic diseases during the COVID-19 epidemic, based on the best available evidence and expert experiences. Levels of evidence and recommendations were determined by the method of the Oxford Centre for EBM Levels of Evidence (2001). These urgent recommendations aim to guide staffs in medical institutions to assist the elderly make sensible meal arrangements during this particular period.
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.