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Objective: To understand the current situation regarding pediatric off-label use of drugs recommendations in Chinese clinical practice guidelines and to make recommendations for standardized reporting format regarding off-label use of drugs for children. Methods: This cross-sectional study was carried out by systematically searching the databases for Chinese guideline consensus articles published in journals between 2018 and 2020 and extracting recommendations regarding off-label use of drugs from those articles. The essential characteristics of the included guidelines, the ranking of off-label drug types, the order of drug information, the type of off-label drug use, and the percentage of citation studies on which the recommendations were based were analyzed. Results: Among 108 studies that included Chinese off-label guidelines and consensus, 364 recommendations on pediatric off-label use of drugs were included. The Chinese Medical Association published the most, 48 out of the 108 studies (44.4%), and of those 14 studies (13.0%) were on infectious and parasitic diseases. Of the 364 recommendations on off-label use of drugs, the most commonly addressed drugs were 16 recommendations (4.4%) for cyclosporine A, 11 recommendations (3.0%) for methotrexate , and 11 recommendations (3.0%) for fentanyl. The most commonly addressed drug categories were as follows: 68 recommendations (18.6%) were immune system drugs, 66 recommendations (18.1%) were anti-infectives, and 56 recommendations (15.4%) were oncology drugs. The most commonly addressed drug information accounts were as follows: 364 recommendations (100.0%) were indications, 204 recommendations (56.0%) were dosages, and 198 recommendations (54.4%) were the route of administration. Based on the instructions approved by the Chinese Food and Drug Administration, the main forms of the off-label drug were as follows: 175 recommendations (48.1%) were unapproved indications, 127 recommendations (34.9%) were unapproved populations, and 72 recommendations (19.8%) were unapproved ages. Only 129 recommendations (35.4%) were cited, mainly including clinical guidelines (48 studies, 23.4%), reviews (22 studies, 10.7%), and pediatric randomized controlled trials (22 studies, 10.7%). Conclusions: Off-label use of drugs is commonly recommended in pediatric guidelines and consensus documents written by Chinese authors. However, the reporting of the recommendations varies widely, and the quality of the supporting evidence is poor.
Subject(s)
Child , Humans , China , Consensus , Cross-Sectional Studies , Off-Label Use , Pharmaceutical PreparationsABSTRACT
@#Objective To analyze the contents of the recommendations of stroke clinical rehabilitation guidelines in order to provide advice for the development and implementation of stroke rehabilitation guidelines.Methods PubMed, EMBASE, CNKI, China Biology Medicine disc, Wanfang databases and guideline-related websites were retrieved from the date of establishment to January 2020, to collect stroke clinical rehabilitation guidelines. The main content, recommendations based on evidence, the type of evidences, and the scope of evidence classification had been explored based on World Health Organization Handbook for Guideline Development-2nd Edition.Results A total of twelve guidelines were included in this study, one in Chinese and eleven in English. They were from the United States (3 guidelines), United Kingdom (3 guidelines), Canada (3 guidelines), Australia (2 guidelines) and China (1 guidelines), and published from September, 2005 to February, 2019. Three articles (25.0%) used the Appraisal of Guidelines for Research and Evaluation (AGREE) for quality evaluation, and two articles (16.7%) used Grading of Recommendations Assessment, Development and Evaluation (GRADE) as the grading system. The recommendations covered the areas such as: cognitive dysfunction (4 dimensions) with a recommendation of cognitive function assessment at most (7 guidelines, 66.7%), language and swallowing dysfunction (5 dimensions) with a recommendation of swallowing-related complications at most (10 guidelines, 83.3%), motor dysfunction (6 dimensions) with a recommendation of spasm treatment at most (10 guidelines, 83.3%), and psychological and behavioral dysfunction (4 dimensions) with a recommendation for assessment or monitoring at most (6 guidelines, 50.0%). There were many recommendations in these areas, but the types of evidence were different, and observational studies and/or randomized controlled trials accounted for most.Conclusion There are different types of evidence and levels of recommendation strength. It is proposed for future guideline developers in stroke rehabilitation to follow World Health Organization Handbook for Guideline Development-2nd Edition to improve the quality and the overall implementation of the rehabilitation guidelines, and to improve the quality and safety of rehabilitation.
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@#Objective To evaluate and analyze the panel composition and conflict of interest management of clinical practice guidelines of rehabilitation.Methods Clinical practice guidelines of rehabilitation were systematically retrieved from PubMed, EMBASE, China Biology Medicine disc, CNKI, Wanfang Data and Medlive database, the National Institute for Health and Care Excellence, National Guideline Clearinghouse, The Scottish Intercollegiate Guidelines Network, World Health Organization (WHO) and Guidelines International Network until January 11, 2020. Two researchers independently screened and cross-checked the literatures, and extracted the basic information of included guidelines, including the title, formulating institution, published journol, as well as the expert group, the number of expert group, the specific division of labor and their discipline, affiliation and the geographic location, the statement and management of conflict of interest, types of conflicts of interest, and whether to accept fund and the source of the fund.Results A total of 84 guidelines were finally included, 17 domestic ones and 67 foreign ones, in which, 52 (61.9%) reported the expert panel; 22 (26.2%) reported the number of expert panel groups, 21 (25.0%) indicated the specific division of work among the members of the expert panel, 74 (88.1%) reported the names of the members of the expert panel, 47 (56.0%) reported the subjects and specialties of the panelists, 70 (83.3%) reported the affiliation and location of panelists, 14 (16.7%) mentioned the management of conflicts of interest, and 25 (29.8%) reported if there were conflicts of interest. Only five of the 16 funded guidelines stated that there was no conflict of interest between the funding and the development of the guidelines. Among them, the reporting rate of expert panel was significantly higher in foreign countries than in China (χ2 = 9.542, P < 0.01), the reporting rate of name of expert panel members and specific division of labor were higher in foreign countries than in China ( χ2 > 4.155, P < 0.05), and the reporting rate of conflict of interest management was also higher in foreign countries than in China ( P < 0.05). There was no significant difference in whether there was a conflict of interest, whether it was funded and the type of funding at home and abroad ( P > 0.05). Conclusion In gerenal, clinical practice guidelines of rehabilitation published at home and abroad are necessary to be improved in the reporting quality of expert group formulation and division of labor, conflict of interest reporting and management. It is proposed that future guideline developers should follow the WHO Handbook for Guideline Development, assign roles of experts, strengthen the management and reporting of conflicts of interest, and standarderize the development process and reporting of the guidelines.