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ObjectiveTo evaluate the methodological and reporting quality of clinical practice guidelines for Chinese patent medicine （CPM） with internationally recognized tools the appraisal of guidelines for research and evaluation （AGEREE） Ⅱ and reporting items for practice guidelines in healthcare （RIGHT）， thereby providing refe-rence for the clinical application and future development of CPM guidelines. MethodsDatabases including CNKI， VIP， Wanfang and Sinomed were searched for CPM guidelines， as well as medlive.cn， websites of China Association of Chinese Medicine and Chinese Medical Association， and reference lists of the included papers. The quality of the guidelines was evaluated using the AGREE Ⅱand RIGHT tools， and consistency tests were performed using Interclass Correlation Coefficient， and descriptive analysis and chi-square test were used to analyze the reporting rate for each domain and the average score for each item. ResultsFinally， 140 CPM guidelines were included， of which 51 were disease-oriented and 89 were drug-oriented， all of which were issued by China. For 51 disease-oriented CPM guidelines， the highest average score of all six AGREE Ⅱ domains was 73.32% for clarity， and the lowest was 26.80% for application； for 89 drug-oriented CPM guidelines， the highest average score was 55.62% for scope and purpose， and the lowest was 31.32% for rigour of development. In terms of the seven domains of the RIGHT checklist， the highest reporting rate was 68.26% for background， and lowest was 27.45% for other areas regarding the disease-oriented CPM guidelines； the highest reporting rate was 61.31% for background， and the lowest was 4.49% for other areas regarding drug-oriented CPM guidelines. The average reporting rate was higher for disease-oriented than drug-oriented CPM guidelines in three domains of AGREE Ⅱ （rigour of development， clarity of presentation， editorial independence）， as well as four domains of RIGHT checklist （basic information， evidence， funding and declaration and management of interests， and other areas）. ConclusionThe overall methodology and reporting quality of the current CPM guidelines still need to be improved. It is recommended that future guideline development teams should strictly refer to the AGREE Ⅱ and RIGHT checklist， and take into account of the characteristics of CPM guidelines and relevant methodo-logical suggestions in the development and reporting of CPM guidelines， thereby guiding the clinical use of CPM in a better way.
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Colorectal cancer is one of the most common malignant tumors of digestive tract. In 2020， 1.93 million new cases of colorectal cancer were diagnosed globally， ranking third in the global incidence spectrum， and 930 000 new deaths were reported， ranking second in the global cause of death spectrum. Meanwhile， the medical cost of metastatic colorectal cancer is the highest among all stages. A large number of studies have demonstrated that traditional Chinese medicine（TCM） treatment can bring clinical benefits to patients with metastatic colorectal cancer with unique efficacy. In order to further standardize the TCM diagnosis and treatment for metastatic colorectal cancer and improve the level of TCM diagnosis and treatment， Xiyuan Hospital， China Academy of Chinese Medical Sciences， together with other relevant units in China， according to the guideline development process of the World Health Organization Handbook for Guideline Development and the relevant requirements of the Clinical Evidence Grading Criteria on TCM Based on Evidence Body， the Regulations for Group Standards of China Association of Chinese Medicine and others， combined with the characteristics of TCM diagnosis and treatment and the actual situation in China， the Guidelines for TCM Diagnosis and Treatment of Metastatic Colorectal Cancer was developed in accordance with the Catalogue of TCM Diagnosis and Treatment Plans for 105 Diseases in 24 Specialties issued by Department of Medical Administration of National Administration of TCM.
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ObjectiveTo evaluate the methodological quality of traditional Chinese medicine （TCM） diagnosis and treatment guidelines/consensus of constipation with Appraisal of Guidelines for Research and Evaluation Ⅱ （AGREE Ⅱ）tool， and to study the attention situation of the included Chinese patent medicines in China's National Reimbursement Drug List in the guidelines/consensus. MethodThe data of CNKI，VIP，Wanfang Data，SinoMed，PubMed and Cochrane from the inception of the databases to October 2021 were searched to collect the TCM diagnosis and treatment guidelines/consensus of constipation. Then，the diagnosis and treatment standards and recommended Chinese patent medicines were extracted. Two researchers assessed the methodological quality of the guidelines/consensus with AGREE Ⅱ tool independently. The quality of reports was evaluated by Reporting Items for practice Guidelines in HealThcare （RIGHT） Statement. The recommended Chinese patent medicines in the guidelines/consensus were compared with those in the National Reimbursement Drug List. ResultEleven consensus and 2 guidelines were included，involving 794 experts. The scores of AGREE II were clarity of presentation（59.0%），scope and purpose（44.0%），stakeholder involvement（23.1%），rigor of development （12.1%），applicability （11.1%），and editorial independence （8.3%） from high to low. Five articles were recommended at B level（recommended after revision） and 8 articles were at C level （not recommended）. The average scores of RIGHT Statement were as follows：basic information （93.59%），background （57.69%），evidence （18.46%），recommendations （20.88%），review and quality assurance （19.23%），funding，declaration and management of interests （0.00%）， and other information （0.00%）. The included guidelines/consensus recommended a total of 27 Chinese patent medicines，among which 20 were included in the National Reimbursement Drug List，with 4 species of Class A and 16 species of Class B， accounting for 74.1% of all recommended Chinese patent medicines. Ten purgative Chinese patent medicines in the National Reimbursement Drug List were recommended by the guidelines/consensus，accounting for 50% of all purgative drugs， and 8 were not recommended. There were prescriptions for purgation， for promoting digestion and removing food stagnation， for clearing heat and purging fire，and for warming the middle and dissipating cold，Tibetan medicine and Mongolian medicine. ConclusionBy the AGREE Ⅱ assessment，the methodological quality of the TCM diagnosis and treatment guidelines/consensus of constipation included in this study needed to be improved in the future. The report quality evaluated with RIGHT Statement was low. Most drugs included in the National Reimbursement Drug List were paid attention in the TCM diagnosis and treatment guidelines/consensus of constipation. Moreover，the drugs included in the National Reimbursement Drug List could basically fulfill the clinical needs reflexed from the guidelines/consensus recommendations. However， the reasons of some drugs failing to be included in the National Reimbursement Drug List needed to be studied in the future.
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OBJECTIVE@#To carry out the methodological quality evaluation and content analysis of the evidence-based clinical practice guidelines for acupuncture-moxibustion in China, and to provide reference for the development and updating of future guidelines.@*METHODS@#With Appraisal of Guidelines for Research and EvaluationⅡ(AGREEⅡ), 20 evidence-based clinical practice guidelines for acupuncture and moxibustion in China were evaluated from six aspects: scope and purpose, stakeholder involvement, rigour of development, clarity of presentation, applicability and editorial independence. In addition, the contents of 20 guidelines were systematically analyzed, and the characteristics of guidelines were summarized from the aspects of disease selection, operation technology type and safety.@*RESULTS@#The scores of six domains were scope and purpose (91.1%), stakeholder involvement (68.5%), rigour of development (68.6%), clarity of presentation (90.3%), applicability (34.5%) and editorial independence (16.7%). The recommendations of the 20 acupuncture guidelines covered common clinical problems such as diagnosis, treatment and precautions, which were in line with the clinical characteristics of acupuncture and moxibustion in terms of content structure.@*CONCLUSION@#The methodology of the evidence-based clinical practice guidelines for acupuncture and moxibustion in China conformed to the requirements of AGREEⅡ on the quality evaluation, and the overall quality was moderate, but the aspects of applicability and editorial independence were still needed to be improved. The contents of recommendations in 20 guidelines were specific and clear, in line with the characteristics of acupuncture and moxibustion, presenting clinical reference value. In the future, in the process of guideline development, the method of developing acupuncture and moxibustion guidelines should be constantly improved to improve the quality of the guidelines; in the meantime, more attention should be paid to the generalization and clinical applicability evaluation.
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Humans , Acupuncture Therapy , China , Evidence-Based Medicine , Evidence-Based Practice , MoxibustionABSTRACT
OBJECTIVE:To evaluate the global existed diarrhea guidelines of children,and provide evidence and methodology reference for clinical practice and the formulation of diarrhea evidence-based guideline of children in China. METHODS:Retrieved from PubMed,Embase,CBM,CNKI,VIP,Wanfang databases and related websites,references included in studies were retrieved additionally from database building to Dec. 2017. The methodological quality of the guideline was evaluated by 2 researchers independently with guideline evaluation toolⅡ(AGREEⅡ). ICC analysis was used to calculate the differences between the evaluation results of 2 researchers and analyze the difference of the guidelines. RESULTS:A total of 1 168 literatures were collected primarily, and 15 guidelines were involved finally,among which 3 guidelines were from USA,2 from British,2 from WHO,each one from Italy,Europe,India,Australia,Malaysia,New South Wales,South Africa and China,respectively. Of 15 guidelines,there were 10 evidence-based guidelines and 5 non-evidence-based guidelines;evidence levels of guidelines and the method of recommendation intensity were different. ICC of 2 researchers were higher than 0.75(P<0.05),indicating good homogeneity among them. The quality of 15 guidelines were not high enough,and the scores of included guidelines in the field of AGREEⅡin descending order were as follows:scope and purpose(84.44%),clarity of presentation(79.82%),stakeholder involvement(45.74%), rigor of development(41.18%), editorial independence (36.39%)and applicability(33.89%). Main prevention and treatment method recommended by guideline included that(1) prevention and treatment of dehydration was the key link in the treatment of children's diarrhea;(2)guidelines generally believed continuous breastfeeding during rehydration could reduce the risk of dehydration in children;(3)zinc preparation was recommended to shorten the course of diarrhea;(4)antibiotics were used rationally, etc. CONCLUSIONS:The quality of global existed diarrhea guidelines of children should be improved. There is no comprehensive diarrhea evidence- based guideline of children in China,and there is a large discrepancy between the situation of pediatric diarrhea therapy in China and WHO standard;it is urgent to establish a standard treatment. It is suggested to formulate high quality pediatric diarrhea guideline in accordance with the national conditions of China,based on standards for international guideline report, comprehensively considering disease burden and characteristics of pediatric diarrhea in China.
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OBJECTIVE: To evaluate evidence-based guidelines of current global pediatric idiopathic thrombocytopenic purpura (ITP) drug therapy, and to provide evidence-based reference for pediatric ITP diagnosis and treatment, the formulation of guideline in China. METHODS: Retrieved from PubMed, Embase, National Guideline Clearinghouse, Guidelines International Network, TRIP medical database, CBM, CJFD, VIP and WANFANG DATA, etc., the evidence-based treatment guideline involving pediatric ITP were included, and methodological quality of the guideline was evaluated by using AGREE Ⅱ tool. The similarities and differences of the guidelines were analyzed and compared. RESULTS: A total of 7 pediatric ITP evidence-based guidelines were included, among which 2 came from US, 2 came from Italy, 2 came from British and another one came from Malaysia. The quality of 7 guidelines were not good, among which 6 guidelines were recommended as grade B and 1 guideline was recommended as grade C; only one GRADE evidence-based guideline was found. The score of included guideline in the field of AGREE Ⅱ was in descending order as scope and purpose, clarity, rigor of development, stakeholder involvement, applicability, editorial independence. The main recommended drugs of these guidelines were: glucocorticoids, intravenous immunoglobulin, anti-D-immunoglobulin, while some guidelines recommend platelet, rituximab and combined medication. CONCLUSIONS: The quality of evidence-based guidelines of ITP for children is in low level and should be improved. There is no evidence-based guideline of ITP for children in China. It is suggested to develop high quality evidence-based guideline for ITP children in China based on AGREE Ⅱ items.
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Objective To review the methodological quality of evidence-based guidelines on prevention and repair of perineal injury at vaginal delivery,and analyze the characteristics of guidelines to provide references for evidence-based decision-making.Methods We systematically searched websites of professional organizations,websites of clinical practice guidelines and databases for guidelines on prevention and repair of perineal injury,and used AGREE Ⅱ to evaluate the chosen guidelines.Results We identified totally 7 relevant evidence-based guidelines in this field.The average standardized scores of guidelines in 6 domains of AGREE Ⅱ were 90.21％(scope and purpose),68.25％ (stakeholder involvement),69.94％ (rigor of development),89.41％ (clarity of presentations),70.63％ (applicability),and 68.25％(independence),respectively.The overall standardized score for 7 guidelines was 75.65％,and the total score was 5.67 (7 points).For overall quality,4 of them were grade A and 3 of them were grade B.Conclusion The overall quality of included guidelines were high,but stakeholder involvement,rigor of development and independence in some guidelines needs to be improved.There was no Chinese evidence-based gui-deline in this field,and high-quality foreign guidelines could be used as evidence in combination with local conditions.
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OBJECTIVE:To systematically review the related evidence-based guidelines of purulent meningitis in children,and to provide evidence-based reference for clinical treatment. METHODS:Retrieved from PubMed,EMBase,CBM,Wanfang Data-base,CJFD and VIP,NGC,GIN,TRIP and websites of domestic and international medical associations and industry bodies,the treatment guidelines about purulent meningitis in children were collected. Evidence-based evaluation was performed after data extrac-tion and quality evaluation. RESULTS:Finally 3 guidelines were enrolled in total,with development time ranging from 2004 to 2012,from USA,Britain and Australia,respectively. All of the recommendations were level B,scope and purpose and clarityshowed the higher scores in AGREEⅡ,more than 70%,and applicability showed generally low scores. Penicillin and cefotaxi-me were recommended in purulent meningitis of neonates,and vancomycin combined with cefotaxime or ceftriaxone were recom-mended for infants and children(it was combined with vancomycin when Streptococcus pneumoniae infection was suspected). The dose and duration of each guideline were certain different,and the period of treatment should be longer in neonates. In addition, the glucocorticoid was recommended in all guidelines. CONCLUSIONS:The recommendations of medicines for the treatment of pu-rulent meningitis are basically unanimous,with no regional difference,but there are some differences about dose and the course of treatment. In addition,the classification criteria of the levels of evidence and recommendation are still suboptimal,which needs fur-ther improvement. And guidelines on purulent meningitis should be improved inrigourandapplicabilityin future.
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Objective To systematic review the methodological quality of guidelines for Guillain-Barré syndrome (GBS) in children, to provide a reference for clinical evidence-based medicine. Methods Guidelines concerning GBS were electronically retrieved from PubMed, EMbase, CBM, Wanfang data, CNKI and Vip. The guide databases includes major medical institutions and industry sites such as NGC, GIN, TRIP , CDC, IDSA, AAP, WHO, Chinese Health and Family Planning Committee website, library of clinical guidelines China and Chinese clinical guidelines for collaboration. All the data were searched from inception of the database or network to Oct. 2013. Two reviews independently screened literature according to the inclusion and exclusion criteria, and assessed the quality of guideline using the AGREEⅡ. Intraclass correlation coefficient (ICC) was used to examine the conformance of the raters' evaluation scores. Results A total of 5 guidelines concerning GBS were included, with a time range from 2003 to 2012, and origins from USA, EU and Canada. The final recommendation levels of the 5 articles were level B. According to the AGREEⅡ, domain 3 and 4 showed the higher scores, and scores were generally low in domain 5. Plasma exchange (PE) and intravenous immuneglobulin (IVIG) showed positive effects on the treatment of GBS. But it was not recommended that combined PE and IVIG. Corticosteroids are also not recommended for GBS treatment. Conclusions The recommendations of medicines for GBS are basically consistent. However, the classification criteria of the levels of evidence and recommendation are still unconsistent and suboptimal. The guidelines on GBS should be improved in“Applicability”in future.