如何区分临床实践指南与专家共识
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摘要
临床实践指南与专家共识作为医学实践中最重要的指导性文件,近年来受到越来越多的关注和研究。目前,国内部分专家对指南和共识的认识和理解存在一定偏差。本文分析和比较了临床实践指南与专家共识的定义、现状和发展,以及二者之间的区别与联系,并结合实例介绍了良好实践主张及其形成条件;最后,就如何提高临床实践指南和专家共识质量提出5条建议,供国内指南和共识的制订者参考。
As the most important guiding documents in the medical practice,clinical practice guidelines and expert consensuses have received more and more attention in recent years. However,partial domestic experts also have understanding biases on guidelines and consensus. Thus,we analyzed and compared guidelines and consensuses on their definition,status,development,connection,and difference. Combined with the example,we introduced good practice statement along with its formation conditions. Finally,we proposed five recommendations on how to improve the quality of clinical practice guidelines and expert consensus in China.
As the most important guiding documents in the medical practice,clinical practice guidelines and expert consensuses have received more and more attention in recent years. However,partial domestic experts also have understanding biases on guidelines and consensus. Thus,we analyzed and compared guidelines and consensuses on their definition,status,development,connection,and difference. Combined with the example,we introduced good practice statement along with its formation conditions. Finally,we proposed five recommendations on how to improve the quality of clinical practice guidelines and expert consensus in China.
引文
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[2]Institute of Medicine.Clinical practice guidelines we can trust[M].Washington DC:the National Academies Press,2011.
[3]王吉耀.用临床实践指南的评价标准指导指南的临床应用[J].上海医学,2018,41:327-328.
[4]王吉耀.肝硬化腹水诊治指南评价[J].中国实用内科杂志,2007,27:563-565.
[5]Institute of Medicine.Clinical practice guidelines:directions for a new program[M].Washington DC:the National Academies Press,1990.
[6]詹思延.临床实践指南的制定应该科学、规范[J].中华儿科杂志,2009,47:163-166.
[7]New Zealand Guidelines Group.Handbook for the Preparation of Explicit Evidence-Based Clinical Practice Guidelines[M/OL].2001.https://trove.nla.gov.au/work/16858035?q&versionId=19787353.
[8]Council of Europe.Developing A Metholology for Drawing Up Guidelines on Best Medical Practices[M/OL].2002.https://www.leitlinien.de/mdb/edocs/pdf/literatur/coerec-2001-13.pdf.
[9]World Health Organization.WHO handbook for guideline development[M/OL].Second edition.2014.http://apps.who.int/medicinedocs/en/m/abstract/Js22083en/.
[10]Scottish Intercollegiate Guidelines Network.SIGN 50:Aguideline developer's handbook[M/OL].2015.https://www.sign.ac.uk/sign-50.html.
[11]The National Institute for Health and Care Excellence.Process and methods guides,Developing NICE guidelines:the manual[M/OL].2015.https://www.nice.org.uk/media/default/about/what-we-do/our-programmes/developing-nice-guidelines-the-manual.pdf.
[12]European Society of Human Reproduction and Embryology.Manual for ESHRE guideline development[M/OL].2017.http://www.guidelines-registry.cn/uploadfile/2016/0914/20160914051552840.pdf.
[13]International Organization for Standardization.Glossary of terms[EB/OL].https://www.iso.org/glossary.html.
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[16]Chen Y,Wang C,Shang H,et al.Clinical practice guidelines in China[J].BMJ,2018,360:j5158.
[17]王吉耀,王强,王小钦,等.中国临床实践指南评价体系的制定与初步验证[J].中华医学杂志,2018,98:1544-1548.
[18]Jiang L,Krumholz HM,Li X,et al.Achieving best outcomes for patients with cardiovascular disease in China by enhancing the quality of medical care and establishing a learning health-care system[J].Lancet,2015,386:1493-1505.
[19]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.
[20]Hu J,Chen R,Wu S,et al.The quality of clinical practice guidelines in China:a systematic assessment[J].J Eval Clin Pract,2013,19:961-967.
[21]Nagler EV,Vanmassenhove J,van der Veer SN,et al.Diagnosis and treatment of hyponatremia:a systematic review of clinical practice guidelines and consensus statements[J].BMC Med,2014,12:1-16.
[22]Jacobs C,Graham ID,Makarski J,et al.Clinical practice guidelines and consensus statements in oncology-an assessment of their methodological quality[J].PLoS One,2014,9:e110469.
[23]Lopez-Olivo MA,Kallen MA,Ortiz Z,et al.Quality appraisal of clinical practice guidelines and consensus statements on the use of biologic agents in rheumatoid arthritis:a systematic review[J].Arthritis Rheum,2008,59:1625-1638.
[24]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.
[25]王小钦,王吉耀.循证临床实践指南的制定与实施[M].北京:人民卫生出版社,2016.
[26]Nair R,Aggarwal R,Khanna D.Methods of formal consensus in classification/diagnostic criteria and guideline development[J].Semin Arthritis Rheum,2011,41:95-105.
[27]王吉耀.制定临床实践指南评价的“中国标准”[J].中华医学杂志,2018,98:1542-1543.
[28]刘晓清,孙晓川.真实世界证据[J].协和医学杂志,2017,8:305-310.
[29]陈耀龙,杨克虎.正确理解、制订和使用临床实践指南[J].协和医学杂志,2018,9:367-373.
[30]Guyatt GH,Alonso-Coello P,Schünemann HJ,et al.Guideline panels should seldom make good practice statements:guidance from the GRADE Working Group[J].JClin Epidemiol,2016,80:3-7.
[31]Guyatt GH,Schünemann HJ,Djulbegovic B,et al.Guideline panels should not GRADE good practice statements[J].J Clin Epidemiol,2015,68:597-600.
[32]Witt DM,Nieuwlaat R,Clark NP,et al.American Society of Hematology 2018 guidelines for management of venous thromboembolism:optimal management of anticoagulation therapy[J].Blood Adv,2018,2:3257-3291.
[33]王吉耀.从循证医学观点评估和应用临床指南[J].中华消化杂志,2004,24:385-386.
[34]Chen Y,Yang K,Maru2ic A,et al.A reporting tool for practice guidelines in health care:the RIGHT statement[J].Ann Intern Med,2017,166:128-132.
[2]Institute of Medicine.Clinical practice guidelines we can trust[M].Washington DC:the National Academies Press,2011.
[3]王吉耀.用临床实践指南的评价标准指导指南的临床应用[J].上海医学,2018,41:327-328.
[4]王吉耀.肝硬化腹水诊治指南评价[J].中国实用内科杂志,2007,27:563-565.
[5]Institute of Medicine.Clinical practice guidelines:directions for a new program[M].Washington DC:the National Academies Press,1990.
[6]詹思延.临床实践指南的制定应该科学、规范[J].中华儿科杂志,2009,47:163-166.
[7]New Zealand Guidelines Group.Handbook for the Preparation of Explicit Evidence-Based Clinical Practice Guidelines[M/OL].2001.https://trove.nla.gov.au/work/16858035?q&versionId=19787353.
[8]Council of Europe.Developing A Metholology for Drawing Up Guidelines on Best Medical Practices[M/OL].2002.https://www.leitlinien.de/mdb/edocs/pdf/literatur/coerec-2001-13.pdf.
[9]World Health Organization.WHO handbook for guideline development[M/OL].Second edition.2014.http://apps.who.int/medicinedocs/en/m/abstract/Js22083en/.
[10]Scottish Intercollegiate Guidelines Network.SIGN 50:Aguideline developer's handbook[M/OL].2015.https://www.sign.ac.uk/sign-50.html.
[11]The National Institute for Health and Care Excellence.Process and methods guides,Developing NICE guidelines:the manual[M/OL].2015.https://www.nice.org.uk/media/default/about/what-we-do/our-programmes/developing-nice-guidelines-the-manual.pdf.
[12]European Society of Human Reproduction and Embryology.Manual for ESHRE guideline development[M/OL].2017.http://www.guidelines-registry.cn/uploadfile/2016/0914/20160914051552840.pdf.
[13]International Organization for Standardization.Glossary of terms[EB/OL].https://www.iso.org/glossary.html.
[14]International Organization for Standardization.We're ISO:we develop and publish international standards[EB/OL].https://www.iso.org/standards.html.
[15]The International Organization for Standardization,the International Electrotechnical Commission.ISO/IEC Guide 2:Standardization and related activities General vocabulary[EB/OL].https://www.iso.org/obp/ui/#iso:std:iso-iec:guide:2:ed-8:v1:en.
[16]Chen Y,Wang C,Shang H,et al.Clinical practice guidelines in China[J].BMJ,2018,360:j5158.
[17]王吉耀,王强,王小钦,等.中国临床实践指南评价体系的制定与初步验证[J].中华医学杂志,2018,98:1544-1548.
[18]Jiang L,Krumholz HM,Li X,et al.Achieving best outcomes for patients with cardiovascular disease in China by enhancing the quality of medical care and establishing a learning health-care system[J].Lancet,2015,386:1493-1505.
[19]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.
[20]Hu J,Chen R,Wu S,et al.The quality of clinical practice guidelines in China:a systematic assessment[J].J Eval Clin Pract,2013,19:961-967.
[21]Nagler EV,Vanmassenhove J,van der Veer SN,et al.Diagnosis and treatment of hyponatremia:a systematic review of clinical practice guidelines and consensus statements[J].BMC Med,2014,12:1-16.
[22]Jacobs C,Graham ID,Makarski J,et al.Clinical practice guidelines and consensus statements in oncology-an assessment of their methodological quality[J].PLoS One,2014,9:e110469.
[23]Lopez-Olivo MA,Kallen MA,Ortiz Z,et al.Quality appraisal of clinical practice guidelines and consensus statements on the use of biologic agents in rheumatoid arthritis:a systematic review[J].Arthritis Rheum,2008,59:1625-1638.
[24]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.
[25]王小钦,王吉耀.循证临床实践指南的制定与实施[M].北京:人民卫生出版社,2016.
[26]Nair R,Aggarwal R,Khanna D.Methods of formal consensus in classification/diagnostic criteria and guideline development[J].Semin Arthritis Rheum,2011,41:95-105.
[27]王吉耀.制定临床实践指南评价的“中国标准”[J].中华医学杂志,2018,98:1542-1543.
[28]刘晓清,孙晓川.真实世界证据[J].协和医学杂志,2017,8:305-310.
[29]陈耀龙,杨克虎.正确理解、制订和使用临床实践指南[J].协和医学杂志,2018,9:367-373.
[30]Guyatt GH,Alonso-Coello P,Schünemann HJ,et al.Guideline panels should seldom make good practice statements:guidance from the GRADE Working Group[J].JClin Epidemiol,2016,80:3-7.
[31]Guyatt GH,Schünemann HJ,Djulbegovic B,et al.Guideline panels should not GRADE good practice statements[J].J Clin Epidemiol,2015,68:597-600.
[32]Witt DM,Nieuwlaat R,Clark NP,et al.American Society of Hematology 2018 guidelines for management of venous thromboembolism:optimal management of anticoagulation therapy[J].Blood Adv,2018,2:3257-3291.
[33]王吉耀.从循证医学观点评估和应用临床指南[J].中华消化杂志,2004,24:385-386.
[34]Chen Y,Yang K,Maru2ic A,et al.A reporting tool for practice guidelines in health care:the RIGHT statement[J].Ann Intern Med,2017,166:128-132.