Publications by authors named "Yao-Long Chen"

22 Publications

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Clinical Practice Guideline for Glycosides/ Tablets in the Treatment of Rheumatoid Arthritis.

Front Pharmacol 2020 14;11:608703. Epub 2021 Jan 14.

Institute of Chinese Materia Medica, China Academy of Chinese Medical Sciences, Beijing, China.

Hook F (HF) is one of the most commonly used and effective traditional Chinese herbal medicines against rheumatoid arthritis (RA). Both Tripterygium Glycoside Tablets (TGT) and Tablets (TWT) are the representative HF-based agents enrolled into the 2019 edition of Medicine Catalog for National Basic Medical Insurance, Injury Insurance, and Maternity Insurance. However, individual differences in TGT/TWT response across patients usually exist in the process of treating RA, implying that the clinical application of the two agents may not be standardized leading to the ineffective treatment and the risk of side effects. Growing evidence show that the bioactive constituents of HF may often have toxicity, the package insert of TGT and TWT may not be described in detail, and the therapeutic windows of the two agents are narrow. Thus, it is an urgent task to develop a standardized clinical practice guideline for TGT and TWT in the treatment of RA. In the current study, a group of clinical experts of traditional Chinese medicine and Western medicine in the research field of rheumatism diseases, pharmacists, and methodologists of evidence-based medicine were invited to select the clinical questions, to determine the levels of the evidence and the strength of the recommendations, and to develop the recommendations and good practice points. The guideline is formed based on the combination of clinical research evidence and expert experience (evidence-based, consensus, supplemented by experience). The clinical problems which are supported by clinical evidence may form recommendations, and the clinical problems without clinical evidence may form experts' suggestions. Both recommendations and experts' suggestions in this guideline summarized the clinical indications, usage, dosage, combined medication, and safety of TGT and TWT against RA systematically and comprehensively, which may offer a professional guidance in the context of the clinical application of the two HF-based agents.
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http://dx.doi.org/10.3389/fphar.2020.608703DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7845140PMC
January 2021

Status Quo and Analysis of the Cardiovascular Clinical Practice Guidelines/Expert Consensuses of Chinese and Integrative Medicine: A Systematic Review.

Chin J Integr Med 2021 Jan 22;27(1):54-61. Epub 2020 May 22.

Key Laboratory of Chinese Internal Medicine of Ministry of Education and Beijing, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, 100700, China.

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.
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http://dx.doi.org/10.1007/s11655-020-2725-3DOI Listing
January 2021

[Technical specification of expert consensus statement in developing clinical practice guidelines of traditional Chinese medicine].

Zhongguo Zhong Yao Za Zhi 2019 Oct;44(20):4354-4359

Beijing Hospital of Traditional Chinese Medicine, Capital Medical University Beijing 100010,China.

The formation of expert consensus statement is an indispensable part in the process of developing clinical practice guidelines. The Guidelines International Network believes that experts make group decisions for different stages and issues,and the process of gathering expert opinions is the process of reaching the consensus. GRADE system also requires that recommendations should be formed based on expert consensus in consideration of the risk and bias,patients' preferences and values,resources and other factors. At present,the main method for reaching consensus is the formal consensus method. According to the published clinical guidelines,most of them failed to report the specific methods and process of reaching expert consensus. Therefore,it is impossible to obtain an objective evaluation. This phenomenon is more common in the field of clinical practice guidelines of traditional Chinese medicine( TCM). There are two main reasons for this phenomenon. For one thing,the developers of the guidelines neglect the importance of transparency and objectivity in the implementation of expert consensus. For another,they know little about the methods and technical specifications for the formation of expert consensus. To solve them,based on the internationally recognized consensus-building methods,as well as the specific stages in the process of developing clinical practice guidelines of traditional Chinese medicine,it is of great significance to put forward the technical norms for TCM researchers to develop the expert consensus. This guide will provide detailed guidance for forming the expert consensus for TCM clinical practice guideline. This guideline has been approved and published by the Chinese Association of Traditional Chinese Medicine( No. T/CACM 1049-2017).
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http://dx.doi.org/10.19540/j.cnki.cjcmm.20190729.501DOI Listing
October 2019

[Expert consensus statement on Kangfu Xiaoyan Suppository in treatment of pelvic inflammatory in clinical practice].

Zhongguo Zhong Yao Za Zhi 2019 Oct;44(20):4350-4353

Evidence-based Medicine Center of Lanzhou University Lanzhou 730000,China.

Kangfu Xiaoyan Suppository is widely used in the treatment of gynecological inflammatory diseases. Long-term clinical application and a certain amount of research evidences show that Kangfu Xiaoyan Suppository can alleviate the clinical symptoms of pelvic inflammatory diseases,reduce the recurrence rate,and relieve sequelae,with a better safety and economic characteristics. As a type of nationally protected traditional Chinese medicine and type B medicine included in medical insurance,it has been selected as a Chinese patent medicine for rectal administration. It was included in the Guidelines for diagnosis and treatment of common gynecological diseases of traditional Chinese medicine published by the Chinese Academy of Traditional Chinese Medicine in 2012,the Pelvic inflammatory diseases diagnosis and treatment guidelines issued by the Infectious Diseases Collaborative Group of the Obstetrics and Gynecology Branch of the Chinese Medical Association in 2014,and the group standard of Single use of traditional Chinese medicine/combined antibiot guidelines for clinical practice-pelvic inflammatory diseases of the Chinese Academy of Traditional Chinese Medicine in 2017. To further enhance clinicians' understanding of the drug and better guide its rational clinical use,experts from the field of gynecology of traditional Chinese and Western medicine were invited to develop and compile this expert consensus. This consensus takes full account of clinical evidences and expert clinical experience,and form recommendations for clinical problems based on evidences and consensus recommendations for clinical problems without evidence by nominal grouping method. The expert consensus is mainly formed in the consideration of six factors: quality of evidence,economy,efficacy,adverse reactions,patient acceptability and others. Based on clinical research evidences and expert experience,this consensus provides a preliminary reference for the clinical use of the drug in a concise and clear format. However,evidence-based support is still required in a large number of high-quality studies,and this consensus will be revised in the future according to new clinical problems and the update of evidence-based evidence in practical application.
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http://dx.doi.org/10.19540/j.cnki.cjcmm.20190726.501DOI Listing
October 2019

[Expert consensus statement on Diemailing~® Kudiezi Injection in clinical practice].

Zhongguo Zhong Yao Za Zhi 2019 Jul;44(14):2926-2931

Evidence-Based Medicine Center of Lanzhou University Lanzhou 730000,China.

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.
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http://dx.doi.org/10.19540/j.cnki.cjcmm.20190509.502DOI Listing
July 2019

Toward Evidence-Based Chinese Medicine: Status Quo, Opportunities and Challenges.

Chin J Integr Med 2018 Mar 16;24(3):163-170. Epub 2018 Jan 16.

Key Laboratory of Chinese Internal Medicine of Ministry of Education, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, 100007, China.

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.
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http://dx.doi.org/10.1007/s11655-017-2795-2DOI Listing
March 2018

Reporting characteristics of case reports of acupuncture therapy with CARE guidelines.

Chin J Integr Med 2018 Jan 28;24(1):56-63. Epub 2017 Nov 28.

College of Acupuncture-Moxibustion and Massage, Shanghai University of Traditional Chinese Medicine, Shanghai, 201203, China.

Objective: 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.

Methods: 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.

Results: 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.

Conclusions: 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.
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http://dx.doi.org/10.1007/s11655-017-2902-1DOI Listing
January 2018

Association between prospective registration and overall reporting and methodological quality of systematic reviews: a meta-epidemiological study.

J Clin Epidemiol 2018 01 31;93:45-55. Epub 2017 Oct 31.

Evidence-Based Medicine Center, School of Basic Medical Sciences of Lanzhou University, Lanzhou 730000, China; Key Laboratory of Evidence-Based Medicine and Knowledge Translation of Gansu Province, Lanzhou 730000, China. Electronic address:

Objectives: The aim of this study was to investigate the differences in main characteristics, reporting and methodological quality between prospectively registered and nonregistered systematic reviews.

Study Design And Setting: PubMed was searched to identify systematic reviews of randomized controlled trials published in 2015 in English. After title and abstract screening, potentially relevant reviews were divided into three groups: registered non-Cochrane reviews, Cochrane reviews, and nonregistered reviews. For each group, random number tables were generated in Microsoft Excel, and the first 50 eligible studies from each group were randomly selected. Data of interest from systematic reviews were extracted. Regression analyses were conducted to explore the association between total Revised Assessment of Multiple Systematic Review (R-AMSTAR) or Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) scores and the selected characteristics of systematic reviews.

Results: The conducting and reporting of literature search in registered reviews were superior to nonregistered reviews. Differences in 9 of the 11 R-AMSTAR items were statistically significant between registered and nonregistered reviews. The total R-AMSTAR score of registered reviews was higher than nonregistered reviews [mean difference (MD) = 4.82, 95% confidence interval (CI): 3.70, 5.94]. Sensitivity analysis by excluding the registration-related item presented similar result (MD = 4.34, 95% CI: 3.28, 5.40). Total PRISMA scores of registered reviews were significantly higher than nonregistered reviews (all reviews: MD = 1.47, 95% CI: 0.64-2.30; non-Cochrane reviews: MD = 1.49, 95% CI: 0.56-2.42). However, the difference in the total PRISMA score was no longer statistically significant after excluding the item related to registration (item 5). Regression analyses showed similar results.

Conclusion: Prospective registration may at least indirectly improve the overall methodological quality of systematic reviews, although its impact on the overall reporting quality was not significant.
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http://dx.doi.org/10.1016/j.jclinepi.2017.10.012DOI Listing
January 2018

[Analysis of reporting specification about sepsis practice guideline based on RIGHT standard].

Zhongguo Zhong Yao Za Zhi 2017 Apr;42(8):1514-1517

Clinical and Basic Research Institute for Traditional Chinese Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China.

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.
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http://dx.doi.org/10.19540/j.cnki.cjcmm.2017.0050DOI Listing
April 2017

[Methodological quality assessment of community-acquired pneumonia clinical practice guidelines in China based on AGREE Ⅱ tool].

Zhongguo Zhong Yao Za Zhi 2017 Jun;42(11):2175-2180

Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China.

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.
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http://dx.doi.org/10.19540/j.cnki.cjcmm.20170419.014DOI Listing
June 2017

Quality assessment of clinical practice guidelines for integrative medicine in China: A systematic review.

Chin J Integr Med 2017 May 1;23(5):381-385. Epub 2016 Dec 1.

Department of Standardization, Guangdong Provincial Hospital of Chinese Medicine, Guangdong, 510120, China.

Objective: To assess the quality of integrative medicine clinical practice guidelines (CPGs) published before 2014.

Methods: 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).

Results: 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%).

Conclusions: 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.
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http://dx.doi.org/10.1007/s11655-016-2739-zDOI Listing
May 2017

Therapeutic drug monitoring of vancomycin: a guideline of the Division of Therapeutic Drug Monitoring, Chinese Pharmacological Society.

J Antimicrob Chemother 2016 11 11;71(11):3020-3025. Epub 2016 Jul 11.

Department of Pharmacy, Peking University Third Hospital, Beijing, China

Background: Guideline development should be based on the quality of evidence, balance of benefits and harms, economic evaluation and patients' views and preferences. Therefore, these factors were considered in the development of a new guideline for therapeutic drug monitoring (TDM) of vancomycin.

Objectives: To develop an evidence-based guideline for vancomycin TDM and to promote standardized vancomycin TDM in clinical practice in China.

Methods: We referred to the WHO Handbook for Guideline Development and used the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system to rate the quality of evidence and grade the strength of recommendations, according to economic evaluation and patients' views and preferences. We used the GRADE Grid method to formulate the recommendations.

Results: The guideline presents recommendations about who should receive vancomycin TDM, how to monitor vancomycin efficacy and renal safety, therapeutic trough concentrations, time to start initial vancomycin TDM, loading dose and how to administer and adjust the vancomycin dose.

Conclusions: We developed an evidence-based guideline for vancomycin TDM, which provides recommendations for clinicians and pharmacists to conduct vancomycin TDM in China.
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http://dx.doi.org/10.1093/jac/dkw254DOI Listing
November 2016

A protocol for developing a clinical practice guideline for therapeutic drug monitoring of vancomycin.

J Huazhong Univ Sci Technolog Med Sci 2016 Jun 5;36(3):469-472. Epub 2016 Jul 5.

Department of Pharmacy, Peking University Third Hospital, Beijing, 100191, China.

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).
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http://dx.doi.org/10.1007/s11596-016-1610-yDOI Listing
June 2016

The quality of evidence in Chinese meta-analyses needs to be improved.

J Clin Epidemiol 2016 06 11;74:73-9. Epub 2016 Jan 11.

Evidence Based Medicine Center, School of Basic Medical Sciences, Lanzhou University, NO. 199 of Donggang Road, Lanzhou, China. Electronic address:

Objectives: We conducted a systematic review using GRADE (Grading of Recommendations Assessment, Development and Evaluation) system to assess the quality of evidence of Chinese meta-analyses (MAs).

Design/setting: A systematic review of MAs listed in Chinese Biomedicine Literature Database from January 2010 to December 2012.

Methods: Mesh term "meta-analysis" was used to search the Chinese Biomedicine Literature Database from January 2010 to December 2012. Characteristics and main outcomes of each included MA were extracted, and the GRADE system was used to assess the quality of evidence for each outcome. A 10% random sample of Cochrane MAs between 2010 and 2012 was also assessed as control group.

Results: A total of 564 Chinese MAs (including 1,237 main outcomes) and 95 Cochrane MAs (including 251 main outcomes) were identified. Almost half (600, 48.5%) of the outcomes in Chinese MAs were rated as low, and the proportion of outcomes with high or moderate quality of evidence was lower in Chinese MAs than Cochrane MAs (Chinese, 406 [32.8%] vs. Cochrane MAs, 155 [61.8%], P < 0.001). Of the outcomes in Chinese MAs, 1,012 (81.8%) were downgraded for risk of bias. Other common factors for downgrading were imprecision (448, 36.2%), publication bias (418, 33.8%), inconsistency (351, 28.4%), and indirectness (1, 0.1%).

Conclusions: Chinese MAs were of low quality of evidence. Risk of bias, inconsistency, and publication bias were the three most common downgrade factors in Chinese MAs. Efforts must be made to improve quality of evidence of Chinese MAs, and a call for more rigorous training of investigators in China is warranted.
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http://dx.doi.org/10.1016/j.jclinepi.2016.01.003DOI Listing
June 2016

The reporting characteristics and methodological quality of Cochrane reviews about health policy research.

Health Policy 2015 Apr 16;119(4):503-10. Epub 2014 Sep 16.

Evidence-Based Medicine Center, School of Basic Medical Sciences, Lanzhou University, Lanzhou 730000, China. Electronic address:

The systematic review has increasingly become a popular tool for researching health policy. However, due to the complexity and diversity in the health policy research, it has also encountered more challenges. We set out the Cochrane reviews on health policy research as a representative to provide the first examination of epidemiological and descriptive characteristics as well as the compliance of methodological quality with the AMSTAR. 99 reviews were included by inclusion criteria, 73% of which were Implementation Strategies, 15% were Financial Arrangements and 12% were Governance Arrangements; involved Public Health (34%), Theoretical Exploration (18%), Hospital Management (17%), Medical Insurance (12%), Pharmaceutical Policy (9%), Community Health (7%) and Rural Health (2%). Only 39% conducted meta-analysis, and 49% reported being updates, and none was rated low methodological quality. Our research reveals that the quantity and quality of the evidence should be improved, especially Financial Arrangements and Governance Arrangements involved Rural Health, Health Care Reform and Health Equity, etc. And the reliability of AMSTAR needs to be tested in larger range in this field.
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http://dx.doi.org/10.1016/j.healthpol.2014.09.002DOI Listing
April 2015

Antivirals for influenza: a summary of a systematic review and meta-analysis of observational studies.

Influenza Other Respir Viruses 2013 Sep;7 Suppl 2:76-81

Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, ON, Canada.

Despite the use of antivirals to treat patients with severe influenza, questions remain with respect to effects and safety. Although a recent systematic review has provided some indication of benefit, the analysis is limited by the quality of the available evidence from randomized controlled trials. To supplement the existing information, the authors conducted a systematic review of observational studies of antiviral treatment for influenza. This report summarises the findings of that review. Similar to the randomised trials, the confidence in the estimates of the effects for decision-making is low to very low primarily due to the risk of selection and publication bias in the observational studies. From these observational studies, the summary estimates suggest that oseltamivir may reduce mortality, hospitalisation and duration of symptoms compared with no treatment. Inhaled zanamivir may also reduce symptom duration and hospitalisations, but patients may experience more complications compared with no treatment. Earlier treatment with antivirals is generally associated with better outcomes than later treatment. Further high-quality evidence is needed to inform treatment guidelines because of the overall low to very low quality of evidence.
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http://dx.doi.org/10.1111/irv.12085DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5909397PMC
September 2013

Surgery combined with intraoperative hyperthermic intraperitoneal chemotherapy (IHIC) for gastric cancer: a systematic review and meta-analysis of randomised controlled trials.

Int J Hyperthermia 2013 ;29(2):156-67

Evidence-Based Medicine Centre of Lanzhou University, Lanzhou, Gansu Province, China.

Background: Adjuvant intraoperative hyperthermic intraperitoneal chemotherapy (IHIC) is a therapy which combines thermotherapy and intraperitoneal chemotherapy. It is theoretically powerful for patients with advanced gastric cancer (AGC), but is there evident advantage in clinical practice? We need evidence to guide our decision-making.

Objectives: Meta-analysis was performed to assess the effectiveness and safety of adjuvant intraoperative hyperthermic intraperitoneal chemotherapy (IHIC) for patients with resectable locally advanced gastric cancer, and to provide the reference for clinical practice and study.

Methods: We searched the Cochrane Library, PubMed, Embase, Web of Science and Chinese databases (Chinese BioMedical Literature Database (CBM), China National Knowledge Infrastructure (CNKI) and Wanfang) electronically and also retrieved papers from other sources (tracing related references and communication with other authors). All relevant randomised controlled trials (RCTs) were collected to compare surgery combined with IHIC to surgery without IHIC for AGC. There were no language restrictions. After independent quality assessment and data extraction by two reviewers, meta-analysis was conducted by RevMan 5.1 software.

Results: 16 RCTs involving 1,906 patients were included. Compared with surgery alone, combination therapy (surgery plus IHIC) was associated with a significant improvement in survival rate at 1 year (hazard ratio (HR) = 2.99; 95% confidence interval (CI) = 2.21 to 4.05; p < 0.00001), 2 years (HR = 2.43; 95%CI = 1.81 to 3.26; p < 0.00001), 3 years (HR = 2.63; 95%CI = 2.17 to 3.20; p < 0.00001), 5 years (HR = 2.49; 95%CI = 1.97 to 3.14; p < 0.00001), and 9 years (HR = 2.14; 95%CI = 1.38 to 3.32; p = 0.0007). Compared with surgery alone, combination therapy was associated with a significant reduction in recurrence rate at 2 years (RR = 0.42; 95%CI = 0.29 to 0.61; p < 0.00001), 3 years (RR = 0.35; 95%CI = 0.24 to 0.51; p < 0.00001) and 5 years (RR = 0.47; 95%CI = 0.39 to 0.56; p < 0.00001). IHIC was not found to be associated with higher risks of anastomotic leakage, ileus, bowel perforation, myelosuppression, gastrointestinal reaction and hypohepatia, but it increased the incidence of abdominal pain (RR = 21.46; 95%CI = 5.24 to 87.78; p < 0.00001).

Conclusions: Compared with surgery alone, surgery combined with IHIC can improve survival rate and reduce the recurrence rate, with acceptable safety. However, safety outcomes should be further evaluated by larger samples and high quality studies. Additionally, hyperthermia for the intraperitoneal chemotherapy needs more clinical research.
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http://dx.doi.org/10.3109/02656736.2013.768359DOI Listing
August 2013

Laparoscopy-assisted gastrectomy versus open gastrectomy for resectable gastric cancer: an update meta-analysis based on randomized controlled trials.

Surg Endosc 2013 Jul 30;27(7):2466-80. Epub 2013 Jan 30.

Evidence-based Medicine Center, School of Basic Medical Sciences, Lanzhou University, 199 Dong Gang Road, Cheng Guan District, Lanzhou 730000, Gansu, China.

Background: We carry out a meta-analysis to evaluate the effectiveness and safety of laparoscopy-assisted gastrectomy (LAG) versus open gastrectomy for resectable gastric cancer.

Methods: We searched EMBASE, the Cochrane Library, PubMed, Science Citation Index (SCI), Chinese biomedicine literature database to identify randomized controlled trials (RCTs) from their inception to April 2012. Meta-analyses were performed using RevMan 5.0 software. It was in line with the preferred reporting items for systematic reviews and meta-analyses statement. The quality of evidence was assessed by GRADEpro 3.6.

Results: Eight RCTs totaling 784 patients were analyzed. Compared with open gastrectomy group, no significant differences were found in postoperative mortality (OR = 1.49; 95 % CI 0.29-7.79), anastomotic leakage (OR = 1.02; 95 % CI 0.24-4.27) , overall mean number of harvested lymph nodes [weighed mean difference (MD) = -3.17; 95 % CI -6.39 to 0.05]; the overall postoperative complication morbidity (OR = 0.54; 95 % CI 0.36-0.82), estimated blood loss (MD = -107.23; 95 % CI -148.56 to -65.89,) frequency of analgesic administration (MD = -1.69; 95 % CI -2.18 to -1.21, P < 0.00001), incidence of pulmonary complications (OR = 0.43, 95 % CI 0.20-0.93, P = 0.03) were significantly less in LAG group; LAG had shorter time to start first flatus (MD = -0.23; 95 % CI -0.41 to -0.05) and decreased hospital stay (MD = -1.72; 95 % CI -3.40 to 0.04), but, LAG still had longer operation time (MD = 76.70; 95 % CI 51.54-101.87).

Conclusions: On the basis of this meta-analysis we conclude that although LAG was still a time-consuming and technically dependent procedure, it has the advantage of better short-term outcome. Long term survival data from other studies are urgently needed to estimate the survival benefit of this technique.
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http://dx.doi.org/10.1007/s00464-012-2758-6DOI Listing
July 2013

Quality assessment of clinical guidelines in China: 1993 - 2010.

Chin Med J (Engl) 2012 Oct;125(20):3660-4

Evidence-Based Medicine Center, School of Basic Medical Sciences, Lanzhou University, Lanzhou, Gansu 730000, China.

Background: 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.

Methods: 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.

Results: 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%).

Conclusions: 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.
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October 2012

Antivirals for treatment of influenza: a systematic review and meta-analysis of observational studies.

Ann Intern Med 2012 Apr 27;156(7):512-24. Epub 2012 Feb 27.

McMaster University, Hamilton, Ontario, Canada.

Background: Systematic reviews of randomized, controlled trials in patients with influenza suggest a lack of evidence about the effects of antiviral therapy on several patient-important outcomes of influenza.

Purpose: To systematically review observational studies for benefits and harms of oseltamivir, zanamivir, amantadine, or rimantadine in the treatment of influenza.

Data Sources: MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials, CINAHL, SIGLE, the Chinese Biomedical Literature Database, Panteleimon, and LILACS up to November 2010; contact with pharmaceutical companies; and reference lists.

Study Selection: Observational studies in any language that compared single antiviral therapy with no therapy or other antiviral therapy, or that had no comparator, for influenza or influenza-like illness.

Data Extraction: Two independent investigators extracted data. Confidence in the estimates of the obtained effects (quality of evidence) was assessed by using the Grading of Recommendations Assessment, Development, and Evaluation approach.

Data Synthesis: 74 studies fulfilled the inclusion criteria. Meta-analyses of the few studies providing effects with adjustment for confounders suggest that, in high-risk populations, oral oseltamivir may reduce mortality (odds ratio, 0.23 [95% CI, 0.13 to 0.43]; low-quality evidence), hospitalization (odds ratio, 0.75 [CI, 0.66 to 0.89]; low-quality evidence), and duration of symptoms (33 hours [CI, 21 to 45 hours]; very low-quality evidence) compared with no treatment. Earlier treatment with oseltamivir was generally associated with better outcomes. Inhaled zanamivir may lead to shorter symptom duration (23 hours [CI, 17 to 28 hours]; moderate-quality evidence) and fewer hospitalizations (odds ratio, 0.66 [CI, 0.37 to 1.18]) but more complications than no treatment. Direct comparison of oral oseltamivir and inhaled zanamivir suggests no important differences in key outcomes. Data from 1 study suggest that oral amantadine may reduce mortality and pneumonia associated with influenza A. No included study evaluated rimantadine.

Limitations: Mortality was assessed in high-risk patients, and generalizability is limited. The overall body of evidence is limited by risk for confounding and selection, reporting, and publication bias.

Conclusion: Therapy with oral oseltamivir and inhaled zanamivir may provide a net benefit over no treatment of influenza. However, as with the randomized trials, the confidence in the estimates of the effects for decision making is low to very low. PRIMARY FUNDING SOURCES: World Health Organization and McMaster University.
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http://dx.doi.org/10.7326/0003-4819-156-7-201204030-00411DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6679687PMC
April 2012

CONSORT 2010.

Lancet 2010 Jul;376(9737):230

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http://dx.doi.org/10.1016/S0140-6736(10)61136-1DOI Listing
July 2010
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