The methodology of recommendations in evidence-based clinical practice guideline_Chinese Journal of Evidence-Based Medicine

Authors：

WANG Yunyun ¹ ,  JIN Yinghui ^2,3 , CHEN Yaolong ^4,5 , ZENG Xiantao ⁶ , CHEN Hao ⁷ , WANG Li ¹ , LU Cui ⁸ ,  CAO Hong ⁹

1. Graduate School of Tianjin University of Traditional Chinese Medicine, Tianjin, 300193, P.R.China;
2. Center for Evidence-Based Medicine, Henan University, Kaifeng, 475000, P.R.China;
3. School of Nursing and Health, Henan University, Kaifeng, 475000, P.R.China;
4. Evidence-based Medicine Center, School of Basic Medical Sciences, Lanzhou University, Lanzhou, 730000, P.R.China;
5. Chinese GRADE Center, Lanzhou University, Lanzhou, 730000, P.R.China;
6. Translational Medicine, Zhongnan Hospital, Wuhan University, Wuhan, 430071, P.R.China;
7. The Second Clinical Medical College of Nanjing University of Chinese Medicine, Nanjing, 210023, P.R.China;
8. Emergency Department, Tianjin TEDA hospital, Tianjin, 300193, P.R.China;
9. Department of Bone Medicine, Tianjin Hospital, Tianjin, 300211, P.R.China;

Corresponding author：

JIN Yinghui, Email: jinyinghui0301@163.com; CAO Hong, Email: caohong1968@yeah.net

Keywords：

Evidence-based clinical practice guideline; Evidence; Recommendation; Methodology

DOI：

10.7507/1672-2531.201612007

Video：

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The formulation process of recommendations in evidence-based clinical practice guidelines was often complex and cumbersome. This paper described the evolution of levels of evidence and strength of recommendations in medical research and analyzed existing problems when making recommendations. We also summarized and introduced the method of formulating the final recommendation. At present, there isn’t a perfect and uniform method to guide the formulation of recommendations. But some organizations provided different content frameworks or auxiliary tools to guide formulation of recommendations. Developers of evidence-based clinical practice guidelines can learn from their experiences, combine with their own characteristics of guidelines such as specific target population and specific clinical situations, establish a rational method of recommendations formation.

Citation： WANG Yunyun, JIN Yinghui, CHEN Yaolong, ZENG Xiantao, CHEN Hao, WANG Li, LU Cui, CAO Hong. The methodology of recommendations in evidence-based clinical practice guideline. Chinese Journal of Evidence-Based Medicine, 2017, 17(9): 1085-1092. doi: 10.7507/1672-2531.201612007 Copy

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2.	蒋朱明, 詹思延, 贾晓巍, 等. 制订/修订《临床诊疗指南》基本方法及程序. 中华医学杂志, 2016, 96(4): 250-253.
3.	王行环. 循证临床实践指南的研发与评价 (第一版). 北京: 中国协和医科大学出版社, 2016: 222-281.
4.	李楠, 姚亮, 吴琼芳, 等. 2012～2013 年中国大陆期刊发表临床实践指南质量评价. 中国循证医学杂志, 2015, 15(3): 259-263.
5.	Jin Y, Wang Y, Zhang Y, et al. Nursing practice guideline in China do need reform: a clinical appraisal using the AGREEⅡInstrument. Worldviews Evid Based Nurs, 2016, 13(2): 124-138.
6.	Glasziou P, Vandenbroucke JP, Chalmers I. Assessing the quality of research. BMJ, 2004, 328(7430): 39-41.
7.	Campbell DT, Stanley JC. Experimental and quasi-experimental designs for research. Chicago, IL: Rand McNally College, 1963.
8.	Chalmers I, Hedges L, Cooper H. A brief history of research synthesis. Evaluat Heal Profes, 2002, 25(1): 12-37.
9.	陈耀龙, 李幼平, 杜亮, 等. 医学研究中证据分级和推荐强度的演进. 中国循证医学杂志, 2008, 8(2): 127-133.
10.	刘建平. 传统医学证据体的构成及证据分级的建议. 中国中西医结合杂志, 2007, 27(12): 1061-1069.
11.	Available at: http://www.cebm.net/wp-content/uploads/2014/06/ CEBM-Levels-of-Evidence-2.1.pdf.
12.	汪受传, 陈争光, 徐珊, 等. 建立循证中医药临床实践指南证据分级体系的构想. 世界科学技术-中医药现代化, 2013, 15(7): 1488-1492.
13.	HICPAC. Updating the guideline methodology of the Healthcare Infection Control Practices Advisory Committee(HICPAC). 2009.
14.	Available at: https://www.nhmrc.gov.au/guidelines-publications/information-guideline-developers/resources-guideline-developers.
15.	ACCF/AHA. Methodology manual and policies from the ACCF/AHA task force on practice guidelines. Available at: http://assets.cardiosource.com/Methodology_Manual_for_ACC_AHA_Writing_Committees.pdf.
16.	AAN. Clinical practice guideline process manual. Available at: http://tools.aan.com/globals/axon/assets/9023.pdf.
17.	BHIVA. British HIV Association (BHIVA) guideline development manual. Available at: http://www.bhiva.org/ GuidelineDevelopmentManual.aspx.
18.	ESHRE. Mannual for ESHRE guidelines handbook. Avaliable at: https://www.eshre.eu/Guidelines-and-Legal/Guidelines/ Guideline-development-process.aspx.
19.	Rosenfeld RM, Shiffman RN, Robertson P. Clinical practice guideline development manual: a quality-driven approach for translating evidence into action. Otolaryngol Head Neck Surg, 2013, 148(Suppl 1): S1-S55.
20.	IDSA. Handbook on clinical practice guideline development. Available at: http://www.idsociety.org/uploadedFiles/ IDSA/Guidelines-Patient_Care/Guidelines_By_Others/IDSA%20 Handbook%20on%20CPG%20Development%20for%20Web%2010.13.pdf#search=%22Handbook on Clinical Practice Guideline Development%22.
21.	Center MG. Minds handbook for guidelines development. Available at: http://minds4.jcqhc.or.jp/minds/guideline/ pdf/MindsHB2014.pdf.
22.	WHO. WHO handbook for guideline development (2nd edition). Available at: http://www.who.int/publications/guidelines/ handbook_2nd_ed.pdf?ua=1.
23.	The Joanna Briggs Institute Levels of Evidence and Grade of Recommendation Working Party. Supporting ducument for the Joanna Briggs Institute levels of evidence and grade of recommendation. The Joanna Briggs Institute. Available at: http://joannabriggs.org/jbi-approach.html#tabbed-nav=Levels-of-evidenve.
24.	SIGN. SIGN 50: A guideline developer’s handbook. Available at: http://www.sign.ac.uk/assets/sign50_2015.pdf.
25.	ANZSN, KHA. KHA-CARI guidelines development manual. Available at: http://www.cari.org.au/docs/KHACARI_Guideline_ development_%20manual.pdf.
26.	Available at: https://pilotguidelines.atlassian.net/wiki/display/GW/ Guideline+Development+Process.
27.	BTS. British thoracic society standards of care committee guideline production manual(2016 version). Available at: https://www.brit-thoracic.org.uk/document-library/guidelines-and-quality-standards/guideline-production-documents/bts-guideline-production-manual-2016/.
28.	Ministry of Health Malaysia. Manual on development and implementation of evidence-based clinical practice guidelines. Putrajaya: MoH, 2015. Avaliable at: http://www.moh.gov.my/ english.php/pages/view/117.
29.	USPSTF. U.S. preventive services task force procedure manual. Available at: https://www.uspreventiveservicestaskforce.org/ Page/Name/procedure-manual.
30.	NICE. Developing NICE guidelines: the manual. Available at: https://www.nice.org.uk/process/pmg20/chapter/introduction-and-overview#updating-this-manual.
31.	AtkinsD, Best D, Briss PA, et al. Grading quality of evidence and strength of recommendations. BMJ, 2004, 328(7454): 1490-1494.
32.	Atkins D, Eccles M, Flottorp S, et al. Systems for grading the quality of evidence and the strength of recommendations I: critical appraisal of existing approaches. The GRADE Working Group. BMC Health Serv Res, 2004, 4(1): 38.
33.	Guyatt GH, Oxman AD, Vist GE, et al. GRADE: an emerging consensus on rating quality of evidence and strength of recommendation. BMJ, 2008, 336(7650): 924-926.
34.	曾宪涛, 冷卫东, 李胜, 等. 如何正确理解及使用 GRADE 系统. 中国循证医学杂志, 2011, 11(9): 985-990.
35.	Balshem H, Helf M, Schunemann, HJ, et al. GRADE: guidelines: 3. Rating the quality of evidence of evidence. J of Clinical Epidemiology, 2011, 64(4): 401-406.
36.	Neumann I, Brignardello-Petersen R, Wiercioch W, et al. The GRADE evidence-to-decision framework: a report of its testing and application in 15 international guideline panels. Implementation Science, 2015, 11(1): 1-8.
37.	Schünemann HJ, WierciochW, EtxeandiaI, et al. Guidelines 2.0: systematic development of a comprehensive checklist for a successful guideline enterprise. Recenti Progressi in Medicina, 2014, 186(3): 123-142.
38.	Holger, Schiinemann, Wojtek, et al. 指南 2.0: 为成功制定指南而系统研发的全面清单. 中国循证医学杂志, 2014, 14(9): 1135-1149.
39.	Richardson WS, Wilson MC, Nishikawa J, et al. The well-built clinical question: a key to evidence-based decisions. ACP J Club, 1995, 123(3): 12-13.
40.	Alonsocoello P, Schünemann HJ, Moberg J, et al. GRADE Evidence to Decision (EtD) frameworks: a systematic and transparent approach to making well informed healthcare choices. 1: Introduction. BMJ, 2016, 353: i2016.
41.	王小钦, 王吉耀. 循证临床实践指南的制定与实施 (第一版). 北京: 人民卫生出版社, 2016: 33-34.
42.	Loblaw DA, Prestrud AA, Somerfield MR, et al. American Society of Clinical Oncology Clinical Practice Guidelines: formal systematic review-based consensus methodology. J Clin Oncol, 2012, 30(25): 3136-3140.
43.	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(7665): a744.
44.	陈耀龙, 陈恳, 叶志康, 等. 中国万古霉素治疗药物监测指南的制定. 中国循证医学杂志, 2015, 15(2): 236-239.
45.	Schünemann HJ, Alansary LA, Forland F, et al. Guidelines International Network: principles for disclosure of interests and management of conflicts in guidelines. Ann Inter Med, 2015, 163(7): 548-553.
46.	陈恳, 王琪, 陈耀龙, 等. 《中国万古霉素治疗药物监测指南》推荐意见的外审调查. 中国循证医学杂志, 2015, 15(6): 719-722.
47.	Alonsocoello P, Oxman AD, Moberg J, et al. GRADE Evidence to Decision (EtD) frameworks: a systematic and transparent approach to making well informed healthcare choices. 2: Clinical practice guidelines. BMJ, 2016, 353: i2089.

1. IOM(Institute of Medicine). Clinical practice guidelines we can trust. Washington, DC: The National Academies Press, 2011.
2. 蒋朱明, 詹思延, 贾晓巍, 等. 制订/修订《临床诊疗指南》基本方法及程序. 中华医学杂志, 2016, 96(4): 250-253.
3. 王行环. 循证临床实践指南的研发与评价 (第一版). 北京: 中国协和医科大学出版社, 2016: 222-281.
4. 李楠, 姚亮, 吴琼芳, 等. 2012～2013 年中国大陆期刊发表临床实践指南质量评价. 中国循证医学杂志, 2015, 15(3): 259-263.
5. Jin Y, Wang Y, Zhang Y, et al. Nursing practice guideline in China do need reform: a clinical appraisal using the AGREEⅡInstrument. Worldviews Evid Based Nurs, 2016, 13(2): 124-138.
6. Glasziou P, Vandenbroucke JP, Chalmers I. Assessing the quality of research. BMJ, 2004, 328(7430): 39-41.
7. Campbell DT, Stanley JC. Experimental and quasi-experimental designs for research. Chicago, IL: Rand McNally College, 1963.
8. Chalmers I, Hedges L, Cooper H. A brief history of research synthesis. Evaluat Heal Profes, 2002, 25(1): 12-37.
9. 陈耀龙, 李幼平, 杜亮, 等. 医学研究中证据分级和推荐强度的演进. 中国循证医学杂志, 2008, 8(2): 127-133.
10. 刘建平. 传统医学证据体的构成及证据分级的建议. 中国中西医结合杂志, 2007, 27(12): 1061-1069.
11. Available at: http://www.cebm.net/wp-content/uploads/2014/06/ CEBM-Levels-of-Evidence-2.1.pdf.
12. 汪受传, 陈争光, 徐珊, 等. 建立循证中医药临床实践指南证据分级体系的构想. 世界科学技术-中医药现代化, 2013, 15(7): 1488-1492.
13. HICPAC. Updating the guideline methodology of the Healthcare Infection Control Practices Advisory Committee(HICPAC). 2009.
14. Available at: https://www.nhmrc.gov.au/guidelines-publications/information-guideline-developers/resources-guideline-developers.
15. ACCF/AHA. Methodology manual and policies from the ACCF/AHA task force on practice guidelines. Available at: http://assets.cardiosource.com/Methodology_Manual_for_ACC_AHA_Writing_Committees.pdf.
16. AAN. Clinical practice guideline process manual. Available at: http://tools.aan.com/globals/axon/assets/9023.pdf.
17. BHIVA. British HIV Association (BHIVA) guideline development manual. Available at: http://www.bhiva.org/ GuidelineDevelopmentManual.aspx.
18. ESHRE. Mannual for ESHRE guidelines handbook. Avaliable at: https://www.eshre.eu/Guidelines-and-Legal/Guidelines/ Guideline-development-process.aspx.
19. Rosenfeld RM, Shiffman RN, Robertson P. Clinical practice guideline development manual: a quality-driven approach for translating evidence into action. Otolaryngol Head Neck Surg, 2013, 148(Suppl 1): S1-S55.
20. IDSA. Handbook on clinical practice guideline development. Available at: http://www.idsociety.org/uploadedFiles/ IDSA/Guidelines-Patient_Care/Guidelines_By_Others/IDSA%20 Handbook%20on%20CPG%20Development%20for%20Web%2010.13.pdf#search=%22Handbook on Clinical Practice Guideline Development%22.
21. Center MG. Minds handbook for guidelines development. Available at: http://minds4.jcqhc.or.jp/minds/guideline/ pdf/MindsHB2014.pdf.
22. WHO. WHO handbook for guideline development (2nd edition). Available at: http://www.who.int/publications/guidelines/ handbook_2nd_ed.pdf?ua=1.
23. The Joanna Briggs Institute Levels of Evidence and Grade of Recommendation Working Party. Supporting ducument for the Joanna Briggs Institute levels of evidence and grade of recommendation. The Joanna Briggs Institute. Available at: http://joannabriggs.org/jbi-approach.html#tabbed-nav=Levels-of-evidenve.
24. SIGN. SIGN 50: A guideline developer’s handbook. Available at: http://www.sign.ac.uk/assets/sign50_2015.pdf.
25. ANZSN, KHA. KHA-CARI guidelines development manual. Available at: http://www.cari.org.au/docs/KHACARI_Guideline_ development_%20manual.pdf.
26. Available at: https://pilotguidelines.atlassian.net/wiki/display/GW/ Guideline+Development+Process.
27. BTS. British thoracic society standards of care committee guideline production manual(2016 version). Available at: https://www.brit-thoracic.org.uk/document-library/guidelines-and-quality-standards/guideline-production-documents/bts-guideline-production-manual-2016/.
28. Ministry of Health Malaysia. Manual on development and implementation of evidence-based clinical practice guidelines. Putrajaya: MoH, 2015. Avaliable at: http://www.moh.gov.my/ english.php/pages/view/117.
29. USPSTF. U.S. preventive services task force procedure manual. Available at: https://www.uspreventiveservicestaskforce.org/ Page/Name/procedure-manual.
30. NICE. Developing NICE guidelines: the manual. Available at: https://www.nice.org.uk/process/pmg20/chapter/introduction-and-overview#updating-this-manual.
31. AtkinsD, Best D, Briss PA, et al. Grading quality of evidence and strength of recommendations. BMJ, 2004, 328(7454): 1490-1494.
32. Atkins D, Eccles M, Flottorp S, et al. Systems for grading the quality of evidence and the strength of recommendations I: critical appraisal of existing approaches. The GRADE Working Group. BMC Health Serv Res, 2004, 4(1): 38.
33. Guyatt GH, Oxman AD, Vist GE, et al. GRADE: an emerging consensus on rating quality of evidence and strength of recommendation. BMJ, 2008, 336(7650): 924-926.
34. 曾宪涛, 冷卫东, 李胜, 等. 如何正确理解及使用 GRADE 系统. 中国循证医学杂志, 2011, 11(9): 985-990.
35. Balshem H, Helf M, Schunemann, HJ, et al. GRADE: guidelines: 3. Rating the quality of evidence of evidence. J of Clinical Epidemiology, 2011, 64(4): 401-406.
36. Neumann I, Brignardello-Petersen R, Wiercioch W, et al. The GRADE evidence-to-decision framework: a report of its testing and application in 15 international guideline panels. Implementation Science, 2015, 11(1): 1-8.
37. Schünemann HJ, WierciochW, EtxeandiaI, et al. Guidelines 2.0: systematic development of a comprehensive checklist for a successful guideline enterprise. Recenti Progressi in Medicina, 2014, 186(3): 123-142.
38. Holger, Schiinemann, Wojtek, et al. 指南 2.0: 为成功制定指南而系统研发的全面清单. 中国循证医学杂志, 2014, 14(9): 1135-1149.
39. Richardson WS, Wilson MC, Nishikawa J, et al. The well-built clinical question: a key to evidence-based decisions. ACP J Club, 1995, 123(3): 12-13.
40. Alonsocoello P, Schünemann HJ, Moberg J, et al. GRADE Evidence to Decision (EtD) frameworks: a systematic and transparent approach to making well informed healthcare choices. 1: Introduction. BMJ, 2016, 353: i2016.
41. 王小钦, 王吉耀. 循证临床实践指南的制定与实施 (第一版). 北京: 人民卫生出版社, 2016: 33-34.
42. Loblaw DA, Prestrud AA, Somerfield MR, et al. American Society of Clinical Oncology Clinical Practice Guidelines: formal systematic review-based consensus methodology. J Clin Oncol, 2012, 30(25): 3136-3140.
43. 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(7665): a744.
44. 陈耀龙, 陈恳, 叶志康, 等. 中国万古霉素治疗药物监测指南的制定. 中国循证医学杂志, 2015, 15(2): 236-239.
45. Schünemann HJ, Alansary LA, Forland F, et al. Guidelines International Network: principles for disclosure of interests and management of conflicts in guidelines. Ann Inter Med, 2015, 163(7): 548-553.
46. 陈恳, 王琪, 陈耀龙, 等. 《中国万古霉素治疗药物监测指南》推荐意见的外审调查. 中国循证医学杂志, 2015, 15(6): 719-722.
47. Alonsocoello P, Oxman AD, Moberg J, et al. GRADE Evidence to Decision (EtD) frameworks: a systematic and transparent approach to making well informed healthcare choices. 2: Clinical practice guidelines. BMJ, 2016, 353: i2089.

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