Analysis on off-label use of drugs in pediatric guidelines and consensus published by Chinese authors / 中华儿科杂志

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.

Proposal of Living Evidence-based Guideline for Combination of Traditional Chinese and Western Medicine for Treatment of COVID-19 / 中国中药杂志

In order to standardize the clinical diagnosis and treatment decision-making with traditional Chinese medicine for pa-tients of coronavirus disease 2019(COVID-19) and put the latest clinical study evidence into clinical practice, the international trust-worthy traditional Chinese medicine recommendations( TCM Recs) working group started the compilation of Living Evidence-based Guideline for Combination of Traditional Chinese and Western Medicine for Treatment of COVID-19 on the basis of the standards and re-quirements of WHO handbook, GRADE and RIGHT. This proposal mainly introduces the formulation methods and processes of the living guidelines in details, such as the composition of the working group, the collection and identification of clinical issues and out-comes, the production of the living systematic review and the consensus of recommendations. The guidelines will continue to monitor the clinical study evidences of TCM in the prevention and treatment of COVID-19, and conduct regular evidence updating, retrieval and screening. When there is new study evidence, the steering committee will evaluate the possibility of the evidence to change clinical practice or previous recommendations, so as to decide whether the recommendations for the guidelines shall be implemented or upda-ted. The main criteria considered in the guideline updating are as follows:(1) There are new high-quality randomized controlled trial(RCT) evidences for TCM uninvolved in the previous edition of the guidelines;(2) as for the TCM involved in the guidelines, living sys-tematic review shows that new evidence may change the direction or strength of the existing recommendations. The specific implementation of the living evidence-based guidelines will take this proposal as the study basis and framework, in order to ensure the standardization of the formulation process and methods. This will be the first exploration of the methodology for living guidelines in the field of TCM.

Status Quo and Analysis of the Cardiovascular Clinical Practice Guidelines/Expert Consensuses of Chinese and Integrative Medicine: A Systematic Review / 中国结合医学杂志

OBJECTIVE@#To describe and analyze the status quo of cardiovascular clinical practice guidelines or expert consensuses including both Chinese medicine (CM) and integrative medicine, through systematic literatures searching and quality assessment.@*METHODS@#Data bases including Chinese Biomedical Literature Database, the China National Knowledge Infrastructure, Wanfang Data, China Science and Technology Journal Database were searched for published CM or integrative cardiovascular clinical practice guidelines or expert consensuses. The website www. medlive.cn was also retrieved as supplementary. The clinical practice evaluation tool AGREE II was used to assess the quality of included guidelines or consensuses.@*RESULTS@#A total of 31 relevant clinical practice guidelines or expert consensuses were included, covering diagnosis, treatment, Chinese patent and patient fields. Common cardiovascular diseases like coronary heart diseases, heart failure and arrhythmia were also involved. Through analysis it was found that both the quantity and quality of included guidelines have been improved year by year. A total of 4 evidence-based clinical practice guideline has been found, one of which was a guideline project plan. Except that, the remaining 27 reports were all consensus-based guidelines. The scores of each field, from highest to lowest, were clarity of presentation (58%), scope and purpose (54%), stakeholder involvement (28%), rigor of development (21%), applicability (13%) and editorial independence (8%).@*CONCLUSIONS@#Although clinical practice guidelines in cardiovascular domain of Chinese have gained increasing concern, with both quantity and quality improved, there is still huge gap in methodology and reporting standards between CM guidelines and international ones. On the one hand, it is essential to improve and standardize the methodology of developing CM guidelines. On the other hands, the evaluation system of evidence and recommendation with CM characters should be developed urgently.

Selecting and defining the clinical questions and outcomes of Guideline for the Emergency Treatment of Anaphylaxis / 北京大学学报(医学版)

OBJECTIVE@#To select and define the clinical questions and outcomes of Guideline for the Emergency Treatment of Anaphylaxis.@*METHODS@#A draft including clinical questions, which could be divided into foreground questions and background questions, and outcomes was drawn and revised by the secretary group for the guideline referring to the present guidelines with the guidance of a panel consisting of 7 experienced clinical medicine, pharmacy and nursing experts. Foreground questions and outcomes of the draft were voted into a final version after three rounds of counsels of 22 experienced medicine, pharmacy and nursing clinical experts using Delphi method including 3 rounds of inquiry. And the background questions were directly included in the guideline after the 22 experts' thorough revising. The research was carried out under the supervision of method ologists. Active coefficient, coefficient of variation and the frequencies of each score were calculated for quality control.@*RESULTS@#The draft of 34 foreground questions, 6 background questions and 6 outcomes was finally drawn up after thorough selecting and consulting. The 6 background questions revised by the clinical experts were all included. After three rounds of Delphi method, 28 pivotal clinical questions covering the diagnosis, preparation for the treatment, treatment and administration after the treatment, and 6 outcomes were defined and included for the guideline. The rest of the foreground questions, 4 of which were recognized as essential and 2 as important, were excluded from the guideline and left for further revising or updating. As for the outcomes, 4 of them were recognized as critical and the rest as important. The experts contributing to the research were active as the active coefficient reached 100%, and the degree of consensus was fine as the frequencies of the feedback scoring equal to or greater than 4 for all the 28 foreground questions included were greater than 75% and the result was settled in the first round. And 2 outcomes, fatality rate and severity, reached a higher degree of consensus with coefficient of variation less than 15%.@*CONCLUSION@#After thorough and rigorous selecting, the clinical questions and outcomes to be included in the Guideline for the Emergency Treatment of Anaphylaxis were finally selected and defined via Delphi method, guiding the future development of the guidelines.

Recommendations of Clinical Practice Guidelines of Stroke Rehabilitation / 中国康复理论与实践

@#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.

Report Quality of Clinical Practice Guidelines of Rehabilitation Based on RIGHT / 中国康复理论与实践

@#Objective To evaluate the quality of reporting of clinical practice guidelines of rehabilitation.Methods A comprehensive retrieve was performed in electronic databases of PubMed, EMBASE, CNKI, China Biology Medicine disc, Wanfang data, etc., from January 1, 2017 to January 11, 2020. Supplementary searches had been done on relevant websites. Two researchers reviewed literatures and assessed the reporting quality independently by using Reporting Items for Practice Guidelines in Healthcare (RIGHT), and any disagreements needed to be discussed in a consensus meeting.Results A total of 16 guidelines were included, with an average reporting rate of (44.8±27.9)%. Among the seven domains of RIGHT, basic information was reported the highest (57.3%), and evidence (31.3%) and other information (31.3%) was the lowest. The reporting rate was less as the guidelines published in China than in foreign contries (OR = 0.80, 95%CI 0.56-1.16), in original version than in update version (OR = 0.79, 95%CI 0.54-1.16); and higher as developed by various societies or associations than developed by non-societies or associations (OR = 1.15, 95%CI 0.82-1.61), however, no statistically significant difference was found in above comparisons.Conclusion Current clinical practice guidelines of rehabilitation reported with low quality. It is proposed that future guideline developers should report guidelines after RIGHT statements, including key information and content, in order to improve the quality of reporting guidelines.

Quality of Evidence and Strength of Recommendations of Clinical Practice Guidelines of Rehabilitation Based on GRADE / 中国康复理论与实践

Objective:To analyze the results of Grading of Recommendations Assessment, Development and Evaluation (GRADE) for clinical practice guidelines of rehabilitation. Methods:Clinical practice guidelines of rehabilitation were systematically retrieved from PubMed, EMBASE, CNKI, China Biology Medicine disc, Wanfang database and the guideline-related websites until January 11, 2020. Two researchers independently screened guidelines using Grading of Recommendations Assessment, Development and Evaluation (GRADE), and extracted and analyzed the results. Results:A total of 83 clinical practice guidelines of rehabilitation were included, in which 46 (55.4%) applied grading systems. Only four (4.8%) guidelines applied GRADE, including 44 recommendations, in which 39 guidelines (88.6%) had quality of evidence. Among the evidences citied in the recommendations, low quality evidences were the most (34.1%); among the recommendations, weak recommendations were more (56.8%). The quality of strong recommendation supporting evidence was higher than that of weak recommendation (χ2 = 8.218,P < 0.05). Conclusion:The application of the GRADE grading system in clinical practice guidelines of rehabilitation remains to be improved. It is proposed for guideline makers to further implement the methodology of guidelines and GRADE to improve the reliability and applicability of the clinical practice guidelines of rehabilitation more effectively.

Clinical Practice Guidelines of Rehabilitation: Composition of Expert Group and Situation of Conflict of Interest / 中国康复理论与实践

@#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.

Clinical Practice Guidelines of Rehabilitation: Methodological Quality / 中国康复理论与实践

@#Objective To evaluate the methodological quality of clinical practice guidelines of rehabilitation using Appraisal of Guidelines for Research and Evaluation (AGREE) II.Methods Clinical practice guidelines of rehabilitation were searched in databases such as PubMed, EMBASE, Wanfang database, CNKI, China Biology Medicine disc and related websites from medlive.cn, National Institute for Health and Care Excellence, National Guideline Clearinghouse, Scottish Intercollegiate Guidelines Network, World Health Organization, and Guidelines International Network from establishment to January 11, 2020. Two researchers reviewed literatures and assessed the methodological quality of the guidelines independently by using AGREE II; any disagreements needed to be discussed in a consensus meeting.Results A total of 84 guidelines were included in the study, with 67 foreign guidelines and 17 domestic guidelines. The average score rate for all the guidelines was 48.1%, in which 49.9% for the foreign guidelines and 40.7% for the domestic guidelines. In the six areas of AGREE II, the average score rate of the foreign guidelines was higher than that of domestic ones (|Z| > 2.034, P < 0.05), expect applicability; the average score rate of clarity and independence improved with the launch of AGREE Ⅱ ( Z > 2.130, P < 0.05). The average scores rate ranged from high to low followed as range and purpose (41.6%), clarity (39.9%), participants (24.5%), rigor (23.2%), independence (15.5%) and applicability (12.9%). Conclusion Clinical practice guidelines of rehabilitation is mainly of low quality by AGREE II. Guideline developers need to work after AGREE Ⅱ standard in the future.

Clinical Practice Guidelines of Rehabilitation: Development Status / 中国康复理论与实践

@#Objective To analyze the development trends and issues of clinical practice guidelines of rehabilitation.Methods Clinical practice guidelines of rehabilitation were retrieved from PubMed, EMBASE, China Biology Medicine disc, CNKI, Wangfang database, Medlive, National Institute for Health and Care Excellence, National Guideline Clearinghouse, Scottish Intercollegiate Guidelines Network, World Health Organization and Guidelines International Network from establishiment to January 11, 2020. The number, publication date, distribution of countries, journals, institutions, subject areas and methods for developing guidelines of included literatures were analyzed. Results A total of 84 clinical practice guidelines of rehabilitation were included, in which there were 17 published in Chinese and 67 in English. The top four countries that published rehabilitation guidelines were the United States (19 articles), China (17 articles), the United Kingdom (12 articles) and Canada (11 articles). The guidelines were developed mainly by the health professional societies and associations (49 articles). The main health conditions involved stroke (12 articles), cardiovascular disease (9 articles), shoulder joint injury (5 articles), pulmonary disease (5 articles) and spinal cord injury (5 articles). There were 35 guidelines expressiong evidence classification and recommendation intensity (42%), and 22 guidelines (26%) would update regularly.Conclusion Clinical practice guidelines of rehabilitation focuse on neurological and musculoskeletal system diseases and cardiopulmonary dysfunction. There are relatively few published clinical practice guidelines for rehabilitation. Most guidelines are based on literature review or expert opinions, while a few are evidence-based. It is proposed to implement standardized approaches to develop clinical practice guidelines of rehabilitation.

Expert consensus statement on Diemailing~® Kudiezi Injection in clinical practice / 中国中药杂志

Diemailing~® Kudiezi Injection( DKI) is widely used in the treatment of cerebral infarction,coronary heart disease and angina pectoris. Long-term clinical application and related research evidence showed that DKI has a good effect in improving the clinical symptoms of cardiovascular and cerebrovascular diseases. However,this injection has not been included in any clinical practice guideline. It has been found that the use of DKI is in wrong way in clinical practice in recent years. Therefore,clinical experts from the field of cardiovascular and cerebrovascular diseases nationwide are invited to compile this expert consensus in order to guide clinicians.GRADE system is used to grade the quality of evidence according to different outcomes according to degrading factors. Then it forms the recommendation or consensus suggestion through the nominal group method. The formation of expert consensus mainly considers six factors: quality of evidence,economy,efficacy,adverse reactions,patient acceptability and others. Based on these six aspects,if the evidence is sufficient,a " recommendation" supported by evidence is formed,and GRADE grid voting rule is adopted. If the evidence is insufficient,a " consensus suggestions" will be formed,using the majority voting rule. In this consensus,the clinical indications,efficacy,safety evidences and related preliminary data of DKI were systematically and comprehensively summarized in a concise and clear format,which could provide valuable reference for the clinical use of DKI. This consensus has been approved by China association of Chinese medicine which is numbered GS/CACM 202-2019.

Toward Evidence-Based Chinese Medicine: Status Quo, Opportunities and Challenges / 中国结合医学杂志

How to test the treatments of Chinese medicine (CM) and make them more widely accepted by practitioners of Western medicine and the international healthcare community is a major concern for practitioners and researchers of CM. For centuries, various approaches have been used to identify and measure the efficacy and safety of CM. However, the high-quality evidence related to CM that produced in China is still rare. Over the recent years, evidence-based medicine (EBM) has been increasingly applied to CM, strengthening its theoretical basis. This paper reviews the past and present state of CM, analyzes the status quo, challenges and opportunities of basic research, clinical trials, systematic reviews, clinical practice guidelines and clinical pathways and evidence-based education developed or conducted in China, pointing out how EBM can help to make CM more widely used and recognized worldwide.

Reporting characteristics of case reports of acupuncture therapy with CARE guidelines / 中国结合医学杂志

<p><b>OBJECTIVE</b>To investigate the reporting characteristics of case reports of acupuncture therapy with CAse Report (CARE) guidelines, and to explore the applicability of the guidelines for these case reports.</p><p><b>METHODS</b>Case reports published from January 1, 2011 to December 31, 2013, were identified by searching PubMed and the China Biomedicine Database by using MeSH terms. Screening and data extraction of case reports were conducted by two independent researchers. Assessments based on CARE guidelines and data analysis were conducted by using Excel 2003 and RevMan 5.0.</p><p><b>RESULTS</b>A total of 61 case reports published in 19 journals were identified, which involved 16 major types of diseases. Fifteen (24.6%) case reports declared no conflict of interests, and 5 (8.2%) reported funding sources. None of these case reports met all items of CARE guidelines, and only 6 subordinate items were fully reported among 50% of the case reports. Subgroup analysis indicated that case reports published in English or those that did not have competing interests had higher reporting quality.</p><p><b>CONCLUSIONS</b>The reporting quality of case reports of acupuncture therapy is rather low. The reason might be a lack of awareness among authors and the poor dissemination of information regarding CARE guidelines in China. More evaluation studies are needed to promote and improve adherence to CARE guidelines. Moreover, an extended version of CARE guidelines should be developed for cases reports of special interventions such as acupuncture or adverse events caused by interventions.</p>

Quality assessment of clinical practice guidelines for integrative medicine in China: A systematic review / 中国结合医学杂志

<p><b>OBJECTIVE</b>To assess the quality of integrative medicine clinical practice guidelines (CPGs) published before 2014.</p><p><b>METHODS</b>A systematic search of the scientific literature published before 2014 was conducted to select integrative medicine CPGs. Four major Chinese integrated databases and one guideline database were searched: the Chinese Biomedical Literature Database (CBM), the China National Knowledge Infrastructure (CNKI), China Science and Technology Journal Database (VIP), Wanfang Data, and the China Guideline Clearinghouse (CGC). Four reviewers independently assessed the quality of the included guidelines using the Appraisal of Guidelines for Research and Evaluation (AGREE) II Instrument. Overall consensus among the reviewers was assessed using the intra-class correlation coefficient (ICC).</p><p><b>RESULTS</b>A total of 41 guidelines published from 2003 to 2014 were included. The overall consensus among the reviewers was good [ICC: 0.928; 95% confifi dence interval (CI): 0.920 to 0.935]. The scores on the 6 AGREE domains were: 17% for scope and purpose (range: 6% to 32%), 11% for stakeholder involvement (range: 0 to 24%), 10% for rigor of development (range: 3% to 22%), 39% for clarity and presentation (range: 25% to 64%), 11% for applicability (range: 4% to 24%), and 1% for editorial independence (range: 0 to 15%).</p><p><b>CONCLUSIONS</b>The quality of integrative medicine CPGs was low, the development of integrative medicine CPGs should be guided by systematic methodology. More emphasis should be placed on multi-disciplinary guideline development groups, quality of evidence, management of funding and conflfl icts of interest, and guideline updates in the process of developing integrative medicine CPGs in China.</p>

Analysis of reporting specification about sepsis practice guideline based on RIGHT standard / 中国中药杂志

At present, the study of clinical practice guide focuses on the quality of the guide, but not enough attention to the reporting standards of the practice guide, so how to standardize the report is an urgent problem in the field of evidence-based medicine. This paper uses the latest practice guidance reporting tool RIGHT standard, analyzes the latest two sepsis practice guidelines at home and abroad, and found that there are few problems in the basic information, recommendations and other information in 7 major areas, and many deficiencies in background, evidence, review and quality assurance, funding and declaration and management of interests, in particular, domestic guidance. We hope that the researchers will use the RIGHT standard to develop new guidelines for sepsis or other areas, standardize the report of the guide, especially the writing of traditional Chinese medicine guide, should reflect the characteristics of traditional Chinese medicine.

Methodological quality assessment of community-acquired pneumonia clinical practice guidelines in China based on AGREE Ⅱ tool / 中国中药杂志

This study is aimed to identify and assess the methodological quality of community-acquired pneumonia (CAP) clinical practice guidelines (CPG) in China by using AGREE Ⅱ tool. CNKI, SinoMed, Wanfang, and VIP Chinese databases from database establishment to March 2017 were searched by manual retrieval to collect all the clinical practice guidelines prepared by various associations or organizations, then AGREE Ⅱtool was used to assess them. Data in each CPG were analyzed in terms of six domains, including scope and purpose, participants, rigor, clarity and readability, applicability and editorial independence. A total of 4 CPGs were included. The results showed that the scope and purpose scored 45.8%; the clarity of expression scored 44.75%; the participants scored 31.9%; the rigor scored 18.98%; the applicability scored 7%; and finally the editorial independence scored 1%. It is concluded that the quality of applicability and the editorial independence should attained paid more attention in future development or updating of the guidelines. In addition to strengthening the compliance with international general principles, we should also pay attention to the characteristics of traditional Chinese medicine treatment, especially the related evidences as complementary and alternative treatment for western intervention measures.

A protocol for developing a clinical practice guideline for therapeutic drug monitoring of vancomycin / 华中科技大学学报（医学）（英德文版）

This study aimed to develop a guideline for therapeutic drug monitoring (TDM) of vancomycin. We adopted the new guideline definition from the Institute of Medicine (IOM), adhered closely to the six domains of the Appraisal of Guidelines for Research & Evaluation II (AGREE II), and made recommendations based on systematic reviews. We established a Guideline Steering Group and a Guideline Development Group, formulated 12 questions in the form of Population, Intervention, Comparison, Outcome (PICO) and completed a literature search. As far as we know, we will develop the first evidenced-based guideline for vancomycin TDM under the framework of the Grade of Recommendations Assessment, Development and Evaluation (GRADE).

Quality assessment of clinical guidelines in China: 1993 - 2010 / 中华医学杂志(英文版)

<p><b>BACKGROUND</b>Clinical practice guidelines (CPGs) play an important role in healthcare in China as well as in the world. However, the current status and trends of Chinese CPGs are unknown. The aim of this study was to systematically review the present situation and the quality of Chinese CPGs published in the peer-reviewed medical literature.</p><p><b>METHODS</b>To identify Chinese CPGs, a systematic search of relevant literature databases (CBM, WANFANG, VIP, and CNKI) was performed for the period January 1978 to December 2010. We used the AGREE II instrument to assess the quality of the included guidelines.</p><p><b>RESULTS</b>We evaluated 269 guidelines published in 115 medical journals from 1993 to 2010 and produced by 256 different developers. Only four guidelines (1%) described the systematic methods for searching and selecting the evidence, 14 (5%) guidelines indicated an explicit link between the supporting evidence and the recommendations, only one guideline used the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system. Thirty-one guidelines (12%) mentioned updates and the average frequency of update was 5.5 years; none described a procedure for updating the guideline. From the assessment with the Appraisal of Guidelines for Research and Ecaluation II (AGREE II), the mean scores were low for the domains "scope and purpose" (19%) and "clarity of presentation" (26%) and very low for the other domains ("rigour of development" 7%, "stakeholder involvement" 8%, "applicability" 6% and "editorial independence" 2%).</p><p><b>CONCLUSIONS</b>Compared with other studies on the quality of guidelines assessed with the AGREE instrument in other countries, Chinese CPGs received lower scores, which indicates a relatively poor quality of the guidelines. However, there was some increase over time.</p>