Quality of therapeutic drug monitoring guidelines is suboptimal: an evaluation using the Appraisal of Guidelines for Research and Evaluation II instrument
单位：[1]Department of Pharmacy, West China Second University Hospital, Sichuan University, Chengdu, China [2]Evidence-Based Pharmacy Center, West China Second University Hospital, Sichuan University, Chengdu, China [3]Key Laboratory of Birth Defects and Related Diseases of Women and Children, Ministry of Education (Sichuan University), Chengdu, China [4]West China School of Pharmacy, Sichuan University, Chengdu, China [5]Pharmaceutical Department, China-Japan Friendship Hospital, Beijing, China [6]Chinese Cochrane Center, West China Hospital, Sichuan University, Chengdu, China 四川大学华西医院[7]Department of Standardization, National Center for Medical Service Administration, National Health Commission of the People’s Republic of China, Beijing, China [8]Department of Pharmacy, Peking University Third Hospital, Beijing, China [9]Department of Pharmacy, The First Affiliated Hospital of Soochow University, Suzhou, China
Objectives: Although therapeutic drug monitoring (TDM) guidelines are available, systematic evaluations of their methodological quality are scarce. This study aimed to assess the quality of current TDM guidelines using the Appraisal of Guidelines for Research and Evaluation (AGREE) II instrument. Study Design and Setting: We performed a systematic search to identify the relevant TDM guidelines in PubMed, EMBASE, CNKI, Wan Fang Database, CBM, VIP, four main guideline databases (NICE, NGC, GIN, and WHO guideline databases), and official websites of the governments and societies associated with TDM from the inception date to May 2018. Four independent appraisers rated the quality of each TDM guideline using the AGREE II instrument, and the mean score of each AGREE II item was calculated. The overall agreement among the appraisers was evaluated using the intraclass correlation coefficient (ICC). Results: Twenty-eight TDM guidelines satisfied the eligibility criteria from among 12,235 references. The overall agreement among the appraisers was substantial (0.700-0.880). The mean scores for the six AGREE II domains were scope and purpose, 67.7% (95% CI, 64.0-71.4%); stakeholder involvement, 39.8% (95% CI, 33.3-46.3%); rigor of development, 36.0% (95% CI, 28.1-43.9%); clarity and presentation, 61.6% (95% CI, 55.7-67.4%); applicability, 30.6% (95% CI, 26.4-34.8%); and editorial independence, 49.2% (95% CI, 40.0-58.6%). The reviewers recommended only four guidelines, and most of the TDM guidelines were rated as "recommended with modifications." Conclusion: Overall, the quality of TDM guidelines is suboptimal according to the evaluation using the AGREE II instrument. The domains of applicability, rigor of development, stakeholder involvement, and editorial independence of the guidelines need to be reported. In addition, guideline developers closely adhering to the AGREE II instrument and the Grading of Recommendations Assessment Development and Evaluation system are required to draft high-quality and reliable TDM guidelines. (C) 2019 Published by Elsevier Inc.
基金：
National Natural Science Foundation of ChinaNational Natural Science Foundation of China (NSFC) [71503177]; Key Project of Sichuan Provincial Department of Science and Technology: Evidence-based research on the clinical application monitoring system of children's antibacterial drugs [2017JY0067]; National Science and Technology Major Project: Construction of a children's demonstration new drug clinical evaluation technology platform [2017ZX09304029]; Key Project of Sichuan Provincial Health Commission: Evidence-based research on monitoring methods and evaluation tools for rational use of antibacterials in children [18ZD042]
语种：
外文
被引次数：
WOS：
中科院(CAS)分区：
出版当年[2019]版：
大类|2 区医学
小类|2 区卫生保健与服务2 区公共卫生、环境卫生与职业卫生
最新[2025]版：
大类|2 区医学
小类|1 区公共卫生、环境卫生与职业卫生2 区卫生保健与服务
JCR分区：
出版当年[2018]版：
Q1HEALTH CARE SCIENCES & SERVICESQ1PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH
最新[2023]版：
Q1HEALTH CARE SCIENCES & SERVICESQ1PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH
第一作者单位：[1]Department of Pharmacy, West China Second University Hospital, Sichuan University, Chengdu, China [2]Evidence-Based Pharmacy Center, West China Second University Hospital, Sichuan University, Chengdu, China [3]Key Laboratory of Birth Defects and Related Diseases of Women and Children, Ministry of Education (Sichuan University), Chengdu, China [4]West China School of Pharmacy, Sichuan University, Chengdu, China
通讯作者：
通讯机构：[1]Department of Pharmacy, West China Second University Hospital, Sichuan University, Chengdu, China [2]Evidence-Based Pharmacy Center, West China Second University Hospital, Sichuan University, Chengdu, China [3]Key Laboratory of Birth Defects and Related Diseases of Women and Children, Ministry of Education (Sichuan University), Chengdu, China
推荐引用方式(GB/T 7714)：
Zeng Min,Yi Qiusha,Zeng Linan,et al.Quality of therapeutic drug monitoring guidelines is suboptimal: an evaluation using the Appraisal of Guidelines for Research and Evaluation II instrument[J].JOURNAL of CLINICAL EPIDEMIOLOGY.2020,120:47-58.doi:10.1016/j.jclinepi.2019.10.007.
APA：
Zeng, Min,Yi, Qiusha,Zeng, Linan,Chen, Zhe,Mi, Xue...&Zhang, Lingli.(2020).Quality of therapeutic drug monitoring guidelines is suboptimal: an evaluation using the Appraisal of Guidelines for Research and Evaluation II instrument.JOURNAL of CLINICAL EPIDEMIOLOGY,120,
MLA：
Zeng, Min,et al."Quality of therapeutic drug monitoring guidelines is suboptimal: an evaluation using the Appraisal of Guidelines for Research and Evaluation II instrument".JOURNAL of CLINICAL EPIDEMIOLOGY 120.(2020):47-58
医学