ObjectiveTo learn the development and implementation of orphan drug policies, in order to provide decision-making references for the establishment of orphan drug policy according with China's national conditions. MethodsWe electronically searched databases including CBM, CNKI, VIP, EMbase, PubMed, Web of Knowledge, National Library of Medicine, CRD database, The Campbell Library, The Cochrane Library and the drug administration websites of USA, Canada, UK, Ireland, the Netherlands, Germany, Spain, France, Australia, New Zealand, China, India, South Korea, Japan, and South Africa to collect studies about orphan drug policy. The search date was up to February 2014. Two reviewers independently screened literature, and extracted data. Then, all included orphan drug policies were summarized and a comparative analysis was performed. ResultsA total of 110 studies were included. USA, Singapore, Japan, Australia, European Union, Chinese Taiwan and South Korea had introduced orphan drugs incentive policies. South Africa, India, Canada, New Zealand and Chinese Hongkong were producing orphan drugs policy frameworks. The main items of orphan drug policy included marketing exclusivity, tax incentives, technical assistance, grant funding, expedite approval process and prolong re-evaluated time. ConclusionIn mainland China, there is no orphan disease management policy. China should establish specific organization and working procedures, promote orphan drug policy related legislative work, clarify the definition and prevalence of orphan diseases, provide incentive mechanism to promote the research and development of orphan drugs, provide enterprises to develop compensation mechanism to safeguard the rights and interests of patients, as well as establish patients register network platform to track the processes of the diseases.
ObjectiveTo systematically review the methodological quality of guidelines concerning attention-deficit/hyperactivity disorder (ADHD) in children and adolescents, and to compare differences and similarities of the drugs recommended, in order to provide guidance for clinical practice. MethodsGuidelines concerning ADHD were electronically retrieved in PubMed, EMbase, VIP, WanFang Data, CNKI, NGC (National Guideline Clearinghouse), GIN (Guidelines International Network), NICE (National Institute for Health and Clinical Excellence) from inception to December 2013. The methodological quality of included guidelines were evaluated according to the AGREE Ⅱ instrument, and the differences between recommendations were compared. ResultsA total of 9 guidelines concerning ADHD in children and adolescents were included, with development time ranging from 2004 to 2012. Among 9 guidelines, 4 were made by the USA, 3 in Europe and 2 by UK. The levels of recommendations were Level A for 2 guidelines, and Level B for 7 guidelines. The scores of guidelines according to the domains of AGREE Ⅱ decreased from "clarity of presentations", "scope and purpose", "participants", "applicability", "rigour of development" and "editorial independence". Three evidence-based guidelines scored the top three in the domain of "rigour of development". There were slightly differences in the recommendations of different guidelines. ConclusionThe overall methodological quality of ADHD guidelines is suboptimal in different countries or regions. The 6 domains involving 23 items in AGREE Ⅱ vary with scores, while the scores of evidence-base guidelines are higher than those of non-evidence-based guidelines. The guidelines on ADHD in children and adolescents should be improved in "rigour of development" and "applicability" in future. Conflicts of interest should be addressed. And the guidelines are recommended to be developed on the basis of methods of evidence-based medicine, and best evidence is recommended.
ObjectivesTo systematically evaluate the structure, publication type and contents of current guidelines for guideline development, so as to provide methodology references for guideline development in China. MethodsSix biomedical research literature databases, six guideline databases and 18 websites of academic institutions and health administrative departments were searched to locate guidelines for guideline development. We included the latest versions of guidelines from guideline development departments or academic institutions. We extracted information consisting of general guideline information, structure, principles, methods and procedure of guideline development. A descriptive analysis was conducted to analyze the general information, structure, principles, methods and procedure of guidelines among different guidelines for guideline development. ResultsAmong all the included 25 guidelines for guideline development published from 1998 to 2014, 50% of them were from North America. Structure of these guidelines were similar while detail levels of recommended guideline development methods and procedures were slightly different. The guideline development groups, systematic literature search, evidence assessment and recommendation formulation were vital part of guideline development. The ineffective promotion and implementation of guidelines for guideline development were common problems of current guidelines. ConclusionsProcedures recommended by current guidelines for guideline development are almost the same, but the methods and statements are different. We could develop our own guideline for guideline development based on the current relative high-quality guideline in order to provide guidance to the clinical guideline development in China.
ObjectiveTo systematically assess the quality of evidence-based clinical guidelines and to compare the differences and similarities between recommendations, so as to provide references for clinical application. MethodsDatabases such as the TRIP, PubMed, CNKI, VIP, WanFang Data, CBM, National Guideline Clearinghouse and Guidelines International Network were searched to collect evidence-based guidelines on medication therapy for children with rheumatic fever. Methodological quality of included guidelines was assessed according to the AGREE Ⅱ instrument, and differences and similarities among recommendations were compared. ResultsOnly one evidence-based clinical guideline from Australia was included. Among 6 domains which were rated using the AGREE Ⅱ instrument, "scope and purpose", "stakeholder involvement", "rigor of development", "clarity and presentation" and "applicability" were scored more than 50%; while "editorial independence" was scored less than 50%. ConclusionThe included guideline is of relatively high quality; however, its application among Chinese population still has limitations. Thus, the development of national guidelines is urgently needed.
ObjectiveTo systematically assess the quality of evidence-based clinical guidelines on the treatment of children with juvenile idiopathic arthritis and to compare the differences and similarities between recommendations, so as to provide references for clinical application. MethodsDatabases such as the TRIP, PubMed, CNKI, VIP, WanFang Data, CBM, U.S National Guideline Clearinghouse and Guidelines International Network were searched to collect evidencebased guidelines on medication therapy for children with juvenile idiopathic arthritis. Methodological quality of included guidelines was assessed according to the AGREE Ⅲ instrument, and differences and similarities among recommendations were compared. ResultsTwo evidence-based clinical guidelines from Australia and China were included. Among 6 domains of the Australian guideline which were rated using AGREE Ⅲ instrument, "scope and purpose", "stakeholder involvement", "rigor of development", "clarity and presentation", "applicability" and "editorial independence" were scored more than 50%. As for Chinese guideline, "scope and purpose", "stakeholder involvement", "rigor of development", "clarity and presentation" and "editorial independence" was all scored more than 50%, but "applicability" was scored less than 50%. ConclusionThe included guidelines are of high quality and strongly recommended, but the recommendations might exist limitation for Chinese children. Thus, the development of relevant Chinese evidence-based guidelines are urgently needed.
ObjectiveComparing the worldwide Essential Medicines Lists for Children (EMLcs) and National Essential Medicine List (NEML) of China (2012 edition), to provide evidence for establishing EMLc of China. MethodWe searched the official websites of WHO and Ministry of Health of some countries to identify published EMLcs. We compared the situation of updating, the number and classification of medicines, and the dosage forms between these EMLcs and NEML of China (2012). ResultBy August 2013, the WHO, India and South Africa had established EMLc. The number of medicines of NEML of China (2012) ranked first in the four lists. The WHO, India and China classified the medicines by pharmacologic action, while South Africa classified it by anatomical therapeutic chemical (ATC) classification. Except the WHO, India, South Africa and China did not have specific medicines for neonatal care or medicines for diseases of joints. The main administration routes in these four lists were oral administration, injection, and topical application. There were medicine restrictions in EMLcs of WHO and India, while no medicine restrictions in lists of South Africa and China. ConclusionMedicines listed in NEML of China (2012) do not match children's disease burden of China. The applicable dosage forms for children are few and the medicine restrictions are absent for the list. So this list is not suitable for Children.
ObjectiveTo evaluate the developing methodologies of Essential Medicines Lists for Children (EMLcs) in global, in order to provide reference in developing EMLc of China. MethodsWe searched ProQuest, ScienceDirect, SpringerLink and MEDLINE databases, World Health Organization (WHO) official website, and 67 websites of National Ministry of Health and Drug Administration Section, to collect literature about selection methodology of children and/or adult essential medicines list (EML). A descriptive analysis was conducted. ResultsA total of fourteen literatures were included. Of which, 6 were about the essential medicines selection methodology in children, and the other 8 were about the essential medicines selection methodology in adult. The WHO had established independent EMLc selection committee. Paediatricians were involved in the selection of EMLc in the WHO and India. There was no selection criteria and process for EMLc globally. The WHO, India, and South Africa selected their EMLcs referring to the WHO EML selection criteria. The WHO and South Africa had their own updating time, period and process for EMLc. The WHO EMLc was updated per 2 years, which in high frequency and conducts in rigorous process. However, the EMLc of India had not been updated yet. ConclusionIt is suggested that China could build a national EMLc selection committee involving paediatricians and evidence-based medicine experts etc. in referring to the framework of the WHO Child Health Working Group. The EMLc selection criteria and process of China could be established referring to the one of the WHO, based on the disease burden, drug accessibility and medical insurance of children of China. The EMLc of China should be simultaneously updated with the adult EML of China.
ObjectiveTo build the list of appropriate dosage forms and specifications of essential medicines for children which is subsistent abroad and absent in China. MethodsBased on the authoritative data and expert consultation, we established the selection methodology which included the standard of essential medicine for children, the standard of appropriate dosage for children, the standard of appropriate specifications for children, the standard of urgent classification, the standard of urgent level. ResultsThe list of appropriate dosage forms and specifications included 61 medicines which included 20 dosage forms and 112 specifications. 112 specifications included 27 specifications which belong to level Ⅱ, and 85 specifications which belong to level Ⅲ. ConclusionThe established list can be included by the green channel.
ObjectiveTo investigate the type, development time, regional distribution, development methods, structure and contents of therapeutic drug monitoring (TDM) guidelines, so as to provide references for the development of TDM guidelines in China. MethodsGuidelines concerning TDM were electronically retrieved in PubMed, Ovid-EMbase, CNKI, VIP, CBM, WanFang Data, NGC (National Guideline Clearinghouse ), GIN (Guidelines International Network), World Health Organization (WHO) guideline database, official websites of governments and societies associated with TDM from inception to October 2015. Two reviewers independently screened literature, extracted data including basic characteristics, formulation methods and text structure, etc.. Then a descriptive analysis was conducted. ResultsA total of 37 guidelines concerning TDM were included, which involved 4 guidelines for management of TDM, 32 for technical practice and 1 for both of them. The results of analysis showed that: for the integrity of reporting items of guidelines, three (75%) management guidelines ranked grade A, but only 1 (3.13%) technical guidelines ranked grade A. The management specifications of TDM included four aspects as follows: standard terminology, the process specification, quality control and personnel qualification. The recommendations to TDM technology of specific drugs included evidence of TDM, standards and procedures, and personnel qualification. ConclusionThere is a rapid but unbalanced development for abroad TDM guidelines. Most of them are TDM technical guidelines. Evidence-based methods are suggested to be used to develop local TDM guidelines, especially for commonly used medicines and technologies without supporting of existed guidelines.
ObjectiveTo systematically review the quality of evidence-based guidelines (EBGs) on medication therapy for neonatal bacterial meningitis, and compare differences and similarities of the drugs recommended, in order to provide references for clinical application. MethodsDatabases such as the TRIP, PubMed, CNKI, VIP, WanFang, CBM, National Guideline Clearinghouse and Guidelines International Network were searched to collect evidence-based guidelines on medication therapy for neonatal bacterial meningitis. Methodological quality of included studies was assessed according to the AGREE Ⅱ instrument, and the differences and similarities among recommendations were compared. ResultsA total of 4 EBGs were included. Among them, one guideline was developed by the America and three guidelines were by the UK. Only one guideline was developed specially for neonates, while the rest were for neonates and children of different ages. According to the AGREE Ⅱ instrument, "scope and purpose", "stakeholder involvement", "rigor of development", "clarity and presentation", "applicability" and "editorial independence" were scored more than 60%. The recommendations of different guidelines were basically the same, only with conflicts in some areas. ConclusionAlthough most guidelines concerning neonatal bacterial meningitis are of high quality, grading levels of evidence and strength of recommendation should be unified.