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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3.	王行環. 循證臨床實踐指南的研發與評價 (第一版). 北京: 中國協和醫科大學出版社, 2016: 222-281.
4.	李楠, 姚亮, 吳瓊芳, 等. 2012～2013 年中國大陸期刊發表臨床實踐指南質量評價. 中國循證醫學雜志, 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.	陳耀龍, 李幼平, 杜亮, 等. 醫學研究中證據分級和推薦強度的演進. 中國循證醫學雜志, 2008, 8(2): 127-133.
10.	劉建平. 傳統醫學證據體的構成及證據分級的建議. 中國中西醫結合雜志, 2007, 27(12): 1061-1069.
11.	Available at: http://www.cebm.net/wp-content/uploads/2014/06/ CEBM-Levels-of-Evidence-2.1.pdf.
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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.
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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.	曾憲濤, 冷衛東, 李勝, 等. 如何正確理解及使用 GRADE 系統. 中國循證醫學雜志, 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: 為成功制定指南而系統研發的全面清單. 中國循證醫學雜志, 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.	王小欽, 王吉耀. 循證臨床實踐指南的制定與實施 (第一版). 北京: 人民衛生出版社, 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.	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定. 中國循證醫學雜志, 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.	陳懇, 王琪, 陳耀龍, 等. 《中國萬古霉素治療藥物監測指南》推薦意見的外審調查. 中國循證醫學雜志, 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. 蔣朱明, 詹思延, 賈曉巍, 等. 制訂/修訂《臨床診療指南》基本方法及程序. 中華醫學雜志, 2016, 96(4): 250-253.
3. 王行環. 循證臨床實踐指南的研發與評價 (第一版). 北京: 中國協和醫科大學出版社, 2016: 222-281.
4. 李楠, 姚亮, 吳瓊芳, 等. 2012～2013 年中國大陸期刊發表臨床實踐指南質量評價. 中國循證醫學雜志, 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. 陳耀龍, 李幼平, 杜亮, 等. 醫學研究中證據分級和推薦強度的演進. 中國循證醫學雜志, 2008, 8(2): 127-133.
10. 劉建平. 傳統醫學證據體的構成及證據分級的建議. 中國中西醫結合雜志, 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. 汪受傳, 陳爭光, 徐珊, 等. 建立循證中醫藥臨床實踐指南證據分級體系的構想. 世界科學技術-中醫藥現代化, 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. 曾憲濤, 冷衛東, 李勝, 等. 如何正確理解及使用 GRADE 系統. 中國循證醫學雜志, 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: 為成功制定指南而系統研發的全面清單. 中國循證醫學雜志, 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. 王小欽, 王吉耀. 循證臨床實踐指南的制定與實施 (第一版). 北京: 人民衛生出版社, 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. 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定. 中國循證醫學雜志, 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. 陳懇, 王琪, 陳耀龍, 等. 《中國萬古霉素治療藥物監測指南》推薦意見的外審調查. 中國循證醫學雜志, 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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