The guideline for therapeutic drug monitoring guideline development_Chinese Journal of Evidence-Based Medicine

Authors：

 Division of Therapeutic Drug Monitoring, Chinese Pharmacological Society ,  Evidence-Based Pharmacy Committee of Chinese Pharmaceutical Association

Corresponding?author：

Division of Therapeutic Drug Monitoring, Chinese Pharmacological Society, Email: zryhyyzxl@126.com; Evidence-Based Pharmacy Committee of Chinese Pharmaceutical Association, Email: zhanglingli@scu.edu.cn

Keywords：

Therapeutic drug monitoring; Guideline; Guideline for guideline development

DOI：

10.7507/1672-2531.202011090

Video：

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Objective The guideline is formulated to standardize the principles, procedures and methods of developing therapeutic drug monitoring (TDM) guidelines and to promote open, transparent, scientific and credibility of the TDM guidelines.Methods Division of Therapeutic Drug Monitoring, Chinese Pharmacological Society established guideline working groups, declared and managed conflict of interest. The guideline working groups used the Delphi method to formulate the purpose and scope of the guideline and questions in PICO format, searched and synthesized evidence, integrated with Chinese actual situation and TDM characteristics to preliminarily develop recommendations for the guideline for TDM guideline development in China. Through internal discussion of the guideline working groups and external peer review, the content has been improved, and we eventually formulated the guideline suitable for guiding TDM related guidelines development.Results The guideline provide suggestions for problems to be identified and solved in the planning, development, publishing and updating stages of TDM guidelines including forming guideline wording groups, planning guidelines, declaration and management of interests, formulating questions and selecting outcomes, preparing the planning proposal, retrieval and synthesis evidence, evaluating evidence, developing recommendations, drafting guidelines, external review, publishing and spreading guidelines, evaluating guidelines, and updating guidelines.Conclusions This guideline can provide methodological guidance and reference for the development of TDM guidelines.

Citation： Division of Therapeutic Drug Monitoring, Chinese Pharmacological Society, Evidence-Based Pharmacy Committee of Chinese Pharmaceutical Association. The guideline for therapeutic drug monitoring guideline development. Chinese Journal of Evidence-Based Medicine, 2021, 21(2): 125-132. doi: 10.7507/1672-2531.202011090 Copy

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2.	Pippenger CE. Therapeutic drug monitoring: an overview. Ther Drug Monit, 1979, 1(1): 3-9.
3.	張相林. 我國治療藥物監測發展及展望. 中國藥理學與毒理學雜志, 2015, 29(5): 741-743.
4.	Institute of Medicine (US). Clinical practice guidelines we can trust. Washington (DC): National Academies Press (US), 2011.
5.	Chen Y, Yang K, Maru?ic A, et al. A reporting tool for practice guidelines in health care: the RIGHT statement. Ann Intern Med, 2017, 166(2): 128-132.
6.	Oxman AD, Schunemann HJ, Fretheim A. Improving the use of research evidence in guideline development: 14. Reporting guidelines. Health Res Policy Syst, 2006, 4(1): 1-6.
7.	Scottish Intercollegiate Guidelines Network. SIGN 50: a guideline developer’s handbook, 2014-10-01. Available at: http://www.sign.ac.uk.
8.	黃亮, 張伶俐, 李幼平, 等. 國內外治療藥物監測指南現狀的循證研究. 中國循證醫學雜志, 2016, 16(4): 451-459.
9.	Ye ZK, Chen YL, Chen K, et al. Therapeutic drug monitoring of vancomycin: a guideline of the Division of Therapeutic Drug Monitoring, Chinese Pharmacological Society. J Antimicrob Chemother, 2016, 71(11): 3020-3025.
10.	Zeng M, Yi Q, Zeng L, et al. Quality of therapeutic drug monitoring guidelines is suboptimal: an evaluation using the Appraisal of Guidelines for Research and Evaluation II instrument. J Clin Epidemiol, 2020, 120: 47-58.
11.	World Health Organization. WHO Handbook for guideline development (2nd edition). Geneva: World Health Organization, 2014.
12.	中華醫學會肝病學分會中華醫學會感染病學分會. 關于臨床實踐指南制訂的規范. 中華肝臟病雜志, 2015, 23(12): 881-887.
13.	靳英輝, 張林, 黃笛, 等. 臨床實踐指南制訂方法—指南制訂參與人員及組成分配. 中國循證心血管醫學雜志, 2018, 10(4): 385-391.
14.	Pagliari C, Grimshaw J, Eccles M. The potential influence of small group processes on guideline development. J Eval Clin Pract, 2001, 7(2): 165-173.
15.	李慧, 陳耀龍, 謝秀麗, 等. 中醫(中西醫結合)臨床實踐指南制修訂方法——推薦意見與共識. 中華中醫藥雜志, 2016, 31(7): 2657-2661.
16.	蔣朱明, 詹思延, 賈曉巍, 等. 制訂/修訂《臨床診療指南》的基本方法及程序. 中華醫學雜志, 2016, 96(4): 250-253.
17.	National Institute for Health Care Excellence. Developing NICE guidelines: the manual (April 2017 update), 2020-04-01. Available at: nice.org.uk/process/pmg20.
18.	Harris JS, Weiss MS, Haas NS, et al. Methodology for ACOEM's Occupational Medicine Practice Guidelines-2017 Revision. J Occup Environ Med, 2017, 59(9): 913-919.
19.	Vermeulen N, Le Clef N, D’Angelo A, et al. Manual for ESHRE guideline development, 2017-11-25. Available at: https://www.eshre.eu/Guidelines-and-Legal/Guidelines/Guideline-development-process.aspx.
20.	Bischoff SC, Singer P, Koller M, et al. Standard operating procedures for ESPEN guidelines and consensus papers. Clin Nutr, 2015, 34(6): 1043-1051.
21.	Gronseth GS, Cox J, Gloss D, et al. 2017 edition clinical practice guideline process manual, 2017-06-17. Available at: https://www.aan.com/siteassets/home-page/policy-and-guidelines/guidelines/about-guidelines/17guidelineprocman_pg.pdf.
22.	李幼平, 實用循證醫學. 北京: 人民衛生出版社, 2018: 453-466.
23.	鄧生瓊, 曾憲濤. 系統評價/Meta 分析常用中英文數據庫簡介. 羅杰, 冷衛東. 系統評價/Meta 分析理論與實踐. 北京: 軍事醫學科學出版社, 2013: 45-68.
24.	龍囿霖, 張永剛, 李幼平, 等. 全球臨床指南數據庫功能特點及技術參數的比較研究. 中國循證醫學雜志, 2018, 18(3): 254-262.
25.	姚巡. 文獻檢索與文獻管理. 李幼平. 實用循證醫學. 北京: 人民衛生出版社, 2018: 467-495.
26.	Eager M, Smith GD, Altman DG. Systematic reviews in health care: Meta-analysis in context (2nd edition). London: BMJ Publishing Group, BMA House, Tavistock Square, WC1H9JR, 2001.
27.	曾力楠, 李幼平, 張伶俐, 等. 國內外制訂臨床指南的指南的循證評價. 中國循證醫學雜志, 2016, 16(11): 1322-1330.
28.	陳耀龍. GRADE 在系統評價和實踐指南中的應用. 蘭州: 蘭州大學出版社, 2017.
29.	Jaeschke R, Guyatt GH, Dellinger P, et al. Use of GRADE grid to reach decisions on clinical practice guidelines when consensus is elusive. BMJ, 2008, 337: 327-329.
30.	Dans AM, Dans L, Oxman AD, et al. Assessing equity in clinical practice guidelines. J Clin Epidemiol, 2007, 60(6): 540-546.
31.	陳耀龍, 陳懇, 葉志康, 等. 中國萬古霉素治療藥物監測指南的制訂. 中國循證醫學雜志, 2015, 15(2): 236-239.
32.	Dave D, Joanne G, Valerie AP. Handbook on clinical practice guideline. canadian medical association, 2007-07-01. Available at: chrome-extension://ikhdkkncnoglghljlkmcimlnlhkeamad/pdf-viewer/web/viewer.html?file=http%3A%2F%2Fciteseerx.ist.psu.edu%2Fviewdoc%2Fdownload%3Fdoi%3D10.1.1.175.9621%26rep%3Drep1%26type%3Dpdf.
33.	Guyatt GH, Agoritsas T, Lytvyn L, et al. BMJ rapid recommendations: creating tools to support a revolution in clinical practice guideline adoption. Can J Gen Intern Med, 2019, 14(1): 6-12.
34.	Shiffman RN, Shekelle P, Overhage JM, et al. Standardized reporting of clinical practice guidelines: a proposal from the Conference on Guideline Standardization. Ann Intern Med, 2003, 139(6): 493-498.
35.	Martínez García L, Pardo-Hernandez H, Alonso-Coello P. More detail is needed for updating clinical guidelines. Kidney Int, 2016, 90(3): 707-708.
36.	Neuman MD, Goldstein JN, Cirullo MA, et al. Durability of class I American College of Cardiology/American Heart Association clinical practice guideline recommendations. JAMA, 2014, 311(20): 2092-2100.
37.	Shekelle PG, Ortiz E, Rhodes S, et al. Validity of the Agency for Healthcare Research and Quality clinical practice guidelines: how quickly do guidelines become outdated? JAMA, 2001, 286(12): 1461-1467.
38.	Martínez García L, Sanabria AJ, García Alvarez E, et al. The validity of recommendations from clinical guidelines: a survival analysis. CMAJ, 2014, 186(16): 1211-1219.
39.	Shekelle PG. Updating practice guidelines. JAMA, 2014, 311(20): 2072-2073.

1. 中國藥理學會治療藥物監測研究專業委員會. 治療藥物監測工作規范專家共識(2019 版). 中國醫院用藥評價與分析, 2019, 19(8): 897-898, 902.
2. Pippenger CE. Therapeutic drug monitoring: an overview. Ther Drug Monit, 1979, 1(1): 3-9.
3. 張相林. 我國治療藥物監測發展及展望. 中國藥理學與毒理學雜志, 2015, 29(5): 741-743.
4. Institute of Medicine (US). Clinical practice guidelines we can trust. Washington (DC): National Academies Press (US), 2011.
5. Chen Y, Yang K, Maru?ic A, et al. A reporting tool for practice guidelines in health care: the RIGHT statement. Ann Intern Med, 2017, 166(2): 128-132.
6. Oxman AD, Schunemann HJ, Fretheim A. Improving the use of research evidence in guideline development: 14. Reporting guidelines. Health Res Policy Syst, 2006, 4(1): 1-6.
7. Scottish Intercollegiate Guidelines Network. SIGN 50: a guideline developer’s handbook, 2014-10-01. Available at: http://www.sign.ac.uk.
8. 黃亮, 張伶俐, 李幼平, 等. 國內外治療藥物監測指南現狀的循證研究. 中國循證醫學雜志, 2016, 16(4): 451-459.
9. Ye ZK, Chen YL, Chen K, et al. Therapeutic drug monitoring of vancomycin: a guideline of the Division of Therapeutic Drug Monitoring, Chinese Pharmacological Society. J Antimicrob Chemother, 2016, 71(11): 3020-3025.
10. Zeng M, Yi Q, Zeng L, et al. Quality of therapeutic drug monitoring guidelines is suboptimal: an evaluation using the Appraisal of Guidelines for Research and Evaluation II instrument. J Clin Epidemiol, 2020, 120: 47-58.
11. World Health Organization. WHO Handbook for guideline development (2nd edition). Geneva: World Health Organization, 2014.
12. 中華醫學會肝病學分會中華醫學會感染病學分會. 關于臨床實踐指南制訂的規范. 中華肝臟病雜志, 2015, 23(12): 881-887.
13. 靳英輝, 張林, 黃笛, 等. 臨床實踐指南制訂方法—指南制訂參與人員及組成分配. 中國循證心血管醫學雜志, 2018, 10(4): 385-391.
14. Pagliari C, Grimshaw J, Eccles M. The potential influence of small group processes on guideline development. J Eval Clin Pract, 2001, 7(2): 165-173.
15. 李慧, 陳耀龍, 謝秀麗, 等. 中醫(中西醫結合)臨床實踐指南制修訂方法——推薦意見與共識. 中華中醫藥雜志, 2016, 31(7): 2657-2661.
16. 蔣朱明, 詹思延, 賈曉巍, 等. 制訂/修訂《臨床診療指南》的基本方法及程序. 中華醫學雜志, 2016, 96(4): 250-253.
17. National Institute for Health Care Excellence. Developing NICE guidelines: the manual (April 2017 update), 2020-04-01. Available at: nice.org.uk/process/pmg20.
18. Harris JS, Weiss MS, Haas NS, et al. Methodology for ACOEM's Occupational Medicine Practice Guidelines-2017 Revision. J Occup Environ Med, 2017, 59(9): 913-919.
19. Vermeulen N, Le Clef N, D’Angelo A, et al. Manual for ESHRE guideline development, 2017-11-25. Available at: https://www.eshre.eu/Guidelines-and-Legal/Guidelines/Guideline-development-process.aspx.
20. Bischoff SC, Singer P, Koller M, et al. Standard operating procedures for ESPEN guidelines and consensus papers. Clin Nutr, 2015, 34(6): 1043-1051.
21. Gronseth GS, Cox J, Gloss D, et al. 2017 edition clinical practice guideline process manual, 2017-06-17. Available at: https://www.aan.com/siteassets/home-page/policy-and-guidelines/guidelines/about-guidelines/17guidelineprocman_pg.pdf.
22. 李幼平, 實用循證醫學. 北京: 人民衛生出版社, 2018: 453-466.
23. 鄧生瓊, 曾憲濤. 系統評價/Meta 分析常用中英文數據庫簡介. 羅杰, 冷衛東. 系統評價/Meta 分析理論與實踐. 北京: 軍事醫學科學出版社, 2013: 45-68.
24. 龍囿霖, 張永剛, 李幼平, 等. 全球臨床指南數據庫功能特點及技術參數的比較研究. 中國循證醫學雜志, 2018, 18(3): 254-262.
25. 姚巡. 文獻檢索與文獻管理. 李幼平. 實用循證醫學. 北京: 人民衛生出版社, 2018: 467-495.
26. Eager M, Smith GD, Altman DG. Systematic reviews in health care: Meta-analysis in context (2nd edition). London: BMJ Publishing Group, BMA House, Tavistock Square, WC1H9JR, 2001.
27. 曾力楠, 李幼平, 張伶俐, 等. 國內外制訂臨床指南的指南的循證評價. 中國循證醫學雜志, 2016, 16(11): 1322-1330.
28. 陳耀龍. GRADE 在系統評價和實踐指南中的應用. 蘭州: 蘭州大學出版社, 2017.
29. Jaeschke R, Guyatt GH, Dellinger P, et al. Use of GRADE grid to reach decisions on clinical practice guidelines when consensus is elusive. BMJ, 2008, 337: 327-329.
30. Dans AM, Dans L, Oxman AD, et al. Assessing equity in clinical practice guidelines. J Clin Epidemiol, 2007, 60(6): 540-546.
31. 陳耀龍, 陳懇, 葉志康, 等. 中國萬古霉素治療藥物監測指南的制訂. 中國循證醫學雜志, 2015, 15(2): 236-239.
32. Dave D, Joanne G, Valerie AP. Handbook on clinical practice guideline. canadian medical association, 2007-07-01. Available at: chrome-extension://ikhdkkncnoglghljlkmcimlnlhkeamad/pdf-viewer/web/viewer.html?file=http%3A%2F%2Fciteseerx.ist.psu.edu%2Fviewdoc%2Fdownload%3Fdoi%3D10.1.1.175.9621%26rep%3Drep1%26type%3Dpdf.
33. Guyatt GH, Agoritsas T, Lytvyn L, et al. BMJ rapid recommendations: creating tools to support a revolution in clinical practice guideline adoption. Can J Gen Intern Med, 2019, 14(1): 6-12.
34. Shiffman RN, Shekelle P, Overhage JM, et al. Standardized reporting of clinical practice guidelines: a proposal from the Conference on Guideline Standardization. Ann Intern Med, 2003, 139(6): 493-498.
35. Martínez García L, Pardo-Hernandez H, Alonso-Coello P. More detail is needed for updating clinical guidelines. Kidney Int, 2016, 90(3): 707-708.
36. Neuman MD, Goldstein JN, Cirullo MA, et al. Durability of class I American College of Cardiology/American Heart Association clinical practice guideline recommendations. JAMA, 2014, 311(20): 2092-2100.
37. Shekelle PG, Ortiz E, Rhodes S, et al. Validity of the Agency for Healthcare Research and Quality clinical practice guidelines: how quickly do guidelines become outdated? JAMA, 2001, 286(12): 1461-1467.
38. Martínez García L, Sanabria AJ, García Alvarez E, et al. The validity of recommendations from clinical guidelines: a survival analysis. CMAJ, 2014, 186(16): 1211-1219.
39. Shekelle PG. Updating practice guidelines. JAMA, 2014, 311(20): 2072-2073.

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