谁应该参与临床实践指南的制订?Who Should Participate in the Development of Clinical Practice Guidelines?
陈耀龙;马艳芳;周奇;周英凤;吕兰婷;翟所迪;姚晨;商洪才;杨克虎;李幼平;
CHEN Yao-long;MA Yan-fang;ZHOU Qi;ZHOU Ying-feng;LYU Lan-ting;ZHAI Suo-di;YAO Chen;SHANG Hong-cai;YANG Ke-hu;LI You-ping;Evidence-based Medicine Center,School of Basic Medical Sciences,Lanzhou University;WHO Collaborating Center for Guideline Implementation and Knowledge Translation;Chinese GRADE Center;School of Public Health,Lanzhou University;The First Clinical Medical College,Lanzhou University;School of Nursing,Fudan University;Fudan University Centre for Evidence-based Nursing: A Joanna Br
摘要(Abstract):
临床实践指南是指导临床医务工作者科学决策的重要依据。近年随着指南数量的增多,其质量也受到越来越多的关注。但对于谁应该参与指南的制订,应如何科学合理地成立指南制订工作组,目前各指南制订机构和制订手册尚未给出统一明确的要求。本文分析比较了现有指南中参与制订的人员及工作组现状,不同指南制订手册中对指南制订工作组的要求和规定,以及不同机构对指南方法学家的定义和职责,并在此基础上就如何成立指南制订工作组提出思考与建议。
Clinical practice guidelines( CPG) are important tools for supporting evidence-based decision-making to clinicians. In recent years,with the increase in the number of CPGs,their quality has received more and more attention. However,for those who should participate in the development of CPGs and how to form a guideline-development group( GDG) scientifically and reasonably,the institutions and handbooks for guideline development have not yet given clear and unified requirements. Thus,we analyzed and compared the status quo of the GDG formation from the existing guidelines,the requirements and regulations for the GDG formation from different handbooks of guideline development,and the definitions and responsibilities of the guideline methodologists from different institutions. On this basis,we give our recommendations on how to form GDG.
关键词(KeyWords):
临床实践指南;指南制订工作组;方法学家
clinical practice guideline;guideline development group;guideline methodologist
基金项目(Foundation): 国家重点研发计划(2018YFC1705500)
作者(Authors):
陈耀龙;马艳芳;周奇;周英凤;吕兰婷;翟所迪;姚晨;商洪才;杨克虎;李幼平;
CHEN Yao-long;MA Yan-fang;ZHOU Qi;ZHOU Ying-feng;LYU Lan-ting;ZHAI Suo-di;YAO Chen;SHANG Hong-cai;YANG Ke-hu;LI You-ping;Evidence-based Medicine Center,School of Basic Medical Sciences,Lanzhou University;WHO Collaborating Center for Guideline Implementation and Knowledge Translation;Chinese GRADE Center;School of Public Health,Lanzhou University;The First Clinical Medical College,Lanzhou University;School of Nursing,Fudan University;Fudan University Centre for Evidence-based Nursing: A Joanna Br
参考文献(References):
- [1] Institute of Medicine. Clinical practice guidelines we can trust[M]. Washington(DC):National Academies Press,2011.
- [2] Djulbegovic B,Guyatt GH. Progress in evidence-based medicine:a quarter century on[J]. Lancet,2017,390:415-423.
- [3]陈耀龙,罗旭飞,王吉耀,等.如何区分临床实践指南与专家共识[J].协和医学杂志. 2019,10:403-408.
- [4] Chen Y,Wang C,Shang H,et al. Clinical practice guidelines in China[J]. BMJ,2018,360:j5158.
- [5] Shaneyfelt TM,Mayo-Smith MF,Rothwangl J. Are guidelines following guidelines? The methodological quality of clinical practice guidelines in the peer-reviewed medical literature[J]. JAMA,1999,281:1900-1905.
- [6] Grilli R,Magrini N,Penna A,et al. Practice guidelines developed by specialty societies:the need for a critical appraisal[J]. Lancet,2000,355:103-106.
- [7] Lenzer J. Why we can't trust clinical guidelines[J]. BMJ,2013,346:f3830.
- [8]王浩,王和平,柯立鑫,等.中国杂志社或期刊编辑参与临床实践指南制订的现状调查[J].中国循证医学杂志,2019,19:60-67.
- [9]靳英辉,张林,黄笛,等.临床实践指南制定方法———指南制定参与人员及组成分配[J].中国循证心血管医学杂志,2018:385-391.
- [10] Cosgrove L,Shaughnessy AF,Peters SM,et al. Conflicts of interest and the presence of methodologists on guideline development panels:a cross-sectional study of clinical practice guidelines for major depressive disorder[J]. Psychother Psychosom,2017,86:168-170.
- [11] Brouwers MC,Kho ME,Browman GP,et al. AGREEⅡ:advancing guideline development,reporting and evaluation in health care[J]. CMAJ,2010,182:E839-E842.
- [12] Chen Y,Yang K,Maruic'A,et al. A Reporting Tool for Practice Guidelines in Health Care:The RIGHT Statement[J]. Ann Intern Med,2017,166:128-132.
- [13]陈耀龙.卫生保健实践指南的报告规范研究[D].兰州:兰州大学,2015.
- [14] Hirsh J,Guyatt G. Clinical experts or methodologists to write clinical guidelines?[J]. Lancet,2009,374:273-275.
- [15] Sniderman AD, Furberg CD. Why guideline-making requires reform[J]. JAMA,2009,301:429-431.
- [16]张林,赵明娟,黄瑞秀,等. 2017年中国发布的临床实践指南人员构成的分析[J].中国循证医学杂志,2019,19:62-72.
- [17] World Health Organization. WHO Handbook for Guideline Development. Second edition[M/OL]. 2014. http://apps. who. int/medicinedocs/en/m/abstract/Js22083en/.
- [18] National Institute for Health and Care Excellence(Great Britain). Developing NICE guidelines:the manual[M/OL]. 2014. https://www.nice.org.uk/process/pmg20/chapter/introduction-and-overview.
- [19] Scottish Intercollegiate Guidelines Network(SIGN). SIGN50:a guideline developer's handbook[M/OL]. 2015.https://www.sign.ac.uk/sign-50.html.
- [20]蒋朱明,詹思延,贾晓巍,等.制订/修订《临床诊疗指南》的基本方法及程序[J].中华医学杂志,2016,96:250-253.
- [21] Methodologist[EB/OL]. https://en. wiktionary. org/wiki/methodologist.
- [22] Registered Nurses'Association of Ontario. Guideline Development Methodologist[EB/OL]. https://rnao. ca/about/jobs/guideline-development-methodologist-0.
- [23] The American thoracic society. American Thoracic Society Clinical Practice Guideline Development Manual[M/OL].2018. https://www. thoracic. org/statements/document-development/resources/guideline-development-manual. pdf.
- [24] Norris SL,Meerpohl JJ,Akl EA,et al. The skills and experience of GRADE methodologists can be assessed with a simple tool[J]. J Clin Epidemiol,2016,79:150-158.
- [25]中华医学会风湿病学分会. 2018中国类风湿关节炎诊疗指南[J].中华内科杂志,2018,57:242-251.
- [26]《中国血栓性疾病防治指南》专家委员会.中国血栓性疾病防治指南[J].中华医学杂志, 2018, 98:2861-2888.
- [27] Chen YL,Yao L,Xiao XJ,et al. Quality assessment of clinical guidelines in China:1993-2010[J]. Chin Med J(Engl),2012,125:3660-3664.
- [28]王小琴,肖玉洁,马艳芳,等.中国临床实践指南制订者对患者指南认知度的调查[J].中国循证医学杂志,2019,19:18-23.
- [29]肖淑君,高玉婷,王小琴,等.患者指南及其制订方法介绍[J].药品评价,2017,14:44-48.
- [30]王洋洋,陈耀龙,王小琴,等.中医(中西医结合)临床实践指南制修订方法———指南小组的形成与工作流程[J].中华中医药杂志,2016,31:1313-1315.
- 陈耀龙
- 马艳芳
- 周奇
- 周英凤
- 吕兰婷
- 翟所迪
- 姚晨
- 商洪才
- 杨克虎
- 李幼平
CHEN Yao-long- MA Yan-fang
- ZHOU Qi
- ZHOU Ying-feng
- LYU Lan-ting
- ZHAI Suo-di
- YAO Chen
- SHANG Hong-cai
- YANG Ke-hu
- LI You-ping
- Evidence-based Medicine Center
- School of Basic Medical Sciences
- Lanzhou University
- WHO Collaborating Center for Guideline Implementation and Knowledge Translation
- Chinese GRADE Center
- School of Public Health
- Lanzhou University
- The First Clinical Medical College
- Lanzhou University
- School of Nursing
- Fudan University
- Fudan University Centre for Evidence-based Nursing: A Joanna Br
- 陈耀龙
- 马艳芳
- 周奇
- 周英凤
- 吕兰婷
- 翟所迪
- 姚晨
- 商洪才
- 杨克虎
- 李幼平
CHEN Yao-long- MA Yan-fang
- ZHOU Qi
- ZHOU Ying-feng
- LYU Lan-ting
- ZHAI Suo-di
- YAO Chen
- SHANG Hong-cai
- YANG Ke-hu
- LI You-ping
- Evidence-based Medicine Center
- School of Basic Medical Sciences
- Lanzhou University
- WHO Collaborating Center for Guideline Implementation and Knowledge Translation
- Chinese GRADE Center
- School of Public Health
- Lanzhou University
- The First Clinical Medical College
- Lanzhou University
- School of Nursing
- Fudan University
- Fudan University Centre for Evidence-based Nursing: A Joanna Br