A Protocol for Developing a Clinical Practice Guideline for Therapeutic Drug Monitoring of Vancomycin

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）.

The Latest Status and Progress of Domestic and Foreign Regulations on Cosmetic Efficacy Claims

The supervision and administration of cosmetics and its two supporting documents related to efficacy,cosmetics classification rules and classification catalogue and evaluation standard of cosmetic efficacy claims,have been successively introduced and implemented,making China’s cosmetics industry officially enter the era of efficacy evaluation.In the time window when the new era is coming,the definitions of cosmetics in China and other countries are compared.The latest status and progress of regulations on cosmetic efficacy claims in China and other countries are summarized,and the standard methods or guidance of cosmetic efficacy evaluation at home and abroad are introduced.The enlightenment from the supervision systems of cosmetic efficacy in other cosmetic consumer markets around the world are discussed.In addition,the opportunities and challenges for cosmetic enterprises under the background of cosmetic law reform in China are also prospected.

Comparison of RECIST version 1.0 and 1.1 in assessment of tumor response by computed tomography in advanced gastric cancer

Objective： Response Evaluation Criteria in Solid Tumors （RECIST） guideline version 1.0 （RECIST 1.0） was proposed as a new guideline for evaluating tumor response and has been widely accepted as a standardized measure. With a number of issues being raised on RECIST 1.0, however, a revised RECIST guideline version 1.1 （RECIST 1.1） was proposed by the RECIST Working Group in 2009. This study was conducted to compare CT tumor response based on RECIST 1.1 vs. RECIST 1.0 in patients with advanced gastric cancer （AGC）. Methods： We reviewed 61 AGC patients with measurable diseases by RECIST 1.0 who were enrolled in other clinical trials between 2008 and 2010. These patients were retrospectively re-analyzed to determine the concordance between the two response criteria using the κ statistic. Results： The number and sum of tumor diameters of the target lesions by RECIST 1.1 were significantly lower than those by RECIST 1.0 （P〈0.0001）. However, there was excellent agreement in tumor response between RECIST 1.1 and RECIST 1.0 0（κ=0.844）. The overall response rates （ORRs） according to RECIST 1.0 and RECIST 1.1 were 32.7% （20/61） and 34.5% （20/58）, respectively. One patient with partial response （PR） based on RECIST 1.0 was reclassified as stable disease （SD） by RECIST 1.1. Of two patients with SD by RECIST 1.0, one was downgraded to progressive disease and the other was upgraded to PR by RECIST 1.1. Conclusions： RECIST 1.1 provided almost perfect agreement with RECIST 1.0 in the CT assessment of tumor response of AGC.

Appraisal of Clinical Practice Guidelines for Ischemic Stroke Management in Chinese Medicine with Appraisal of Guidelines for Research and Evaluation Instrument:A Systematic Review

Objective： To systematically review the clinical practice guidelines （CPGs） for ischemic stroke in Chinese medicine （CM） with the Appraisal of Guidelines for Research and Evaluation （AGREE II） instrument. Methods： CM CPGs for ischemic stroke were searched in 5 online databases and hand-searches in CPG- related handbooks published from January 1990 to December 2012. The CPGs were categorized into evidence based （EB） guideline, consensus based with no explicit consideration of evidence based （CB-EB） guideline and consensus based （CB） guideline according to the development method. Three reviewers independently appraised the CPGs based on AGREE II instrument, and compared the CPGs＇ recommendations on CM pattern classification and treatment. Results： Five CM CPGs for ischemic stroke were identified and included. Among them, one CPG was EB guideline, two were CB guidelines and two were CB-EB guidelines. The quality score of the EB guideline was higher than those of the CB-EB and CB guidelines. Five CM patterns in the CPGs were recommended in the EB CPG. The comprehensive protocol of integrative Chinese and Western medicine recommended in the EB CPG was mostly recommended for ischemic stroke in the CPGs. The recommendations varied based on the CM patterns. Conclusion： The quality of EB CPG was higher than those of CB and CB-EB CPGs in CM for ischemic stroke and integrative approaches were included in CPGs as major interventions.

Development and preliminary verification of the evaluation system for clinical practice guidelines in China

Objective:Clinical practice guidelines can improve healthcare processes and patient outcomes;however,the quality of these guidelines varies greatly in China.The aim of this study was to construct a comprehensive instrument for the appraisal of clinical practice guidelines in China(AGREE-CHINA),and to validate its reliability as a tool for helping potential guideline users in assessing guideline quality.Methods:First,an interdisciplinary working group was established for developing the methods.They also created a checklist as a tool according to the Appraisal of Guidelines,Research and EvaluationⅡ(AGREEⅡ)standards,considering the particularity of Chinese clinical practice.Next,the first draft of AGREE-China was developed by vote,modification,preliminary trial,and crossverification.To ensure the objectivity,credibility,and reproducibility of the draft assessment,all of the checklists and standards were cross-reviewed fairly widely.Fin ally,AGREE-CHINA and AGREEⅡwere used to assess the Chinese guideli nes published in the past five years,and the results were compared.Results:The presented AGREE-CHINA covered five main checkpoints(science and rigor,effectiveness and safety,economy,usability and feasibility,and conflicts of interest)with each point divided into several more specific checkpoints.Definitions and rationales for each main checkpoint appear in the Appendix.The quality ratings based on the total scores of AGREE-China and AGREEⅡwere consistent(r=0.508,P=0.020).Compared with AGREEⅡ,the study showed a higher level of interraterreliability for AGREE-CHINA overall(ICC=0.957,P<0.001).The mean time required for AGREE-CHINA was less than that for AGREEⅡ:this was approximately 30 minutes for every assessment.User satisfaction was generally high.Conclusions:This paper has presented the first edition of the AGREE-CHINA appraisal tool for clinical guidelines.It is quick and easy to use;it assesses and performs well in comparison to AGREEⅡ.This first version of AGREE-CHINA will require further development and validation.

Quality Assessment of Clinical Practice Guidelines for Integrative Medicine in China:A Systematic Review

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% confidence 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 conflicts of interest, and guideline updates in the process of developing integrative medicine CPGs in China.