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》

作者：

陳耀龍 ¹ ,  李幼平 ¹ , 杜亮 ² , 王莉 ¹ , 文進 ¹ , 楊曉妍 ¹

1.四川大學華西醫院循證醫學與臨床流行病學教研室（成都 610041）2.四川大學華西醫院中國循證醫學雜志編輯部（成都610041）;

關鍵詞：

循證醫學證據分級推薦強度

DOI：

10.7507/1672-2531.20080028

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導出 下載 收藏 掃碼 引用

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本文系統分析了 1979~2007 年間 50 個主要組織和機構的證據分級標準及推薦意見強度，遴選出最具代表性的5個國家和國際組織的11個標準，并從分級特點、影響范圍、使用領域等角度將其分為三個發展階段。目前醫學領域的標準已趨于成熟，并逐步統一。未來的挑戰是在管理、教育、基礎研究、經濟學、社會學、法學等非醫非藥領域引入證據分類分級理念，研究制定符合循證醫學思想，滿足各領域研究和實踐需要的高質量證據分類分級標準和推薦意見強度，接受時間和實踐的檢驗。

引用本文： 陳耀龍,李幼平,杜亮,王莉,文進,楊曉妍. 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, 08(2): 127-133. doi: 10.7507/1672-2531.20080028 復制

1.	McCol l A, Smith H,White P,et al .General practitioner’s perceptions of the route to evidence based medicine: a questionnaire survey. BMJ, 1998, 316(7128): 361-365.
2.	Guyatt G, Meade M,Jaeschke R,et al. Practitioners of evidence based care: not all clinicians need to appraise evidence from scratch but all need some skills. BMJ, 2000, 320(7240): 954-955.
3.	Glasziou P, Vandenbroucke JP, Chalmers I. assessing the qual ity of research. BMJ, 2004, 328(7430): 39-41.
4.	Campbell DT, Stanley JC. Experimental and quasi-experimental designs for Research.Chicago, IL: Rand McNally College, 1963.
5.	Chalmers I, Hedges L, Cooper H. A brief history of research synthesis. Evaluation & the health professions, 2002, 25(1): 12-37.
6.	Canadian Task Force on the Periodic Health Examination: The periodic health examination. CMAJ, 1979, 121(19): 1193-1254.
7.	Schünemann HJ, Best D, Vist G, et al. Letters, numbers, symbols and words: how to communicate grades of evidence and recommendations. CMAJ, 2003, 169(7): 677-680.
8.	Atkins D, Best D, Briss PA, et al. Grading quality of evidence and strength of recommendations. BMJ, 2004, 328(7454): 1490-1494.
9.	Goldbloom R. Weighing the evidence: the Canadian experience. Am J Clin Nutr, 1997, 65(2 suppl): 584S-586S.
10.	Atkins D, Eccles M, Flottorp S. Systems for grading the quality of evidence and the strength of recommendations I: Critical appraisal of existing approaches. BMC Health Serv Res, 2004, 4(1): 38.
11.	Sackett DL. Rules of evidence and cl inical recommendations on the use of antithrombotic agents. Chest, 1986, 89(2 Suppl): 2S-3S.
12.	Sackett DL. Rules of evidence and cl inical recommendations on the use of antithrombotic agents. Archives Int Med, 1986, 146(3): 464-465.
13.	Guyatt GH,Sackett DL,Sinclair JC,et al .Users’ guides to the medical literature.IX. A method for grading health care recommendations. Evidence-Based Medicine Working Group. JAMA, 1995, 274(22): 1800-1804.
14.	Sackett DL. Rules of evidence and cl inical recommendations on the use of antithrombotic agents. Chest, 1989, 95(2): 2S-4S.
15.	Cook DJ, Guyatt GH, Laupacis A,et al. Rules of evidence and cl inical recommendations on the use of antithrombotic agents. Chest, 1992, 102(4): 305S-311S.
16.	Cook DJ, Guyatt GH, Laupacis A, et al. Clinical recommendations using levels of evidence for antithrombotic agents. Chest, 1995, 108(4): 227S-230S.
17.	Guyatt GH, Cook DJ, Sackett DL, et al. Grades of recommendation for antithrombotic agents. Chest, 1998, 114(5 Suppl): 441S-444S.
18.	Guyatt G, Schünemann H, Cook D,et al . Grades of Recommendation for Antithrombotic Agents. Chest, 2001, 119(1): 3S-7S.
19.	Guyatt G, Gutterman D, Baumann MH, et al. Grading strength of recommendations and quality of evidence in clinical guidel ines: report from an american college of chest physicians task force. Chest, 2006, 129(1): 174-181.
20.	http://www.inclen.org/history.html.
21.	陳潔. 醫學技術評估. 上海: 上海醫科大學出版社. 1996.
22.	Cochrane A. Effectiveness and Efficiency: Random Reflections on Health Services. London: Nuffield Provincial Hospitals Trust, 1972.
23.	Guyatt GH. 循證醫學的五個發展方向. 中國循證醫學雜志, 2006, 6(3): 175-161.
24.	Cinical Practice Guideline No.1: acute pain management: operative or medical procedures and trauma. Rockville (MD): US Department of Health and Human Services. Agency for Health Care Pol icy and Research; 1993. AHCPR Publication No. 92-0023.
25.	http://www.ncbi.nlm.nih.gov/books/bv.fcgi?rid=hstat6.table.928626 Eccles M, Clapp Z, Grimshaw J, et al. Russell I: North of England evidence based guidelines development project: methods of guidel ine development. BMJ, 1996, 312(7033): 760-762.
26.	Harbour R, Miller J. A new system for grading recommendations in evidence based guidelines. BMJ, 2001, 323(7308): 334-336.
27.	Van Tulder W, Koes W, Bouter M. Conservative treatment of acute and chronic nonspecific low back pain. A systematic review of randomized controlled trials of the most common interventions. Spine, 1997, 22(18): 2128-2156.
28.	Working Party for Guidelines for the Management of Heavy Menstrual Bleeding.An evidence-based guideline for the management of heavy menstrual bleeding. N Z Med J,1999, 112(1088): 174-177.
29.	National Health and Medical Research Council (NHMRC). How to Use the Evidence: Assessment and Appl ication of Scientific Evidence. Canberra, Austral ia: NHMRC; 2000.
30.	http://www.cebm.net/levels_of_evidence.asp.
31.	李幼平, 主編. 循證醫學. 第1版. 北京: 高等教育出版社.
32.	http://www.gradeworkinggroup.org/about_us.htm.
33.	http://library.downstate.edu/ebmdos/2100.htm.
34.	Aragon CL, Budsberg SC. Applications of Evidence-Based Medicine: Cranial Cruciate Ligament Injury Repair in the Dog Veterinary Surgery. 34(2): 93–98.
35.	李幼平, 陶鐵軍, 孫丁, 等. 我國專科醫師分類研究初探. 中國循證醫學雜志, 2004, 4(3): 173-180.
36.	謝瑜, 文進, 高曉鳳, 等. 國外航空風險管理方法及績效的循證評價——醫療風險系列研究之一. 中國循證醫學雜志, 2006, 6(2): 131-138.
37.	高曉鳳,謝瑜,文進, 等.我國煤礦業風險管理現狀的循證評價——醫療風險系列研究之二. 中國循證醫學雜志, 2006, (3): 202-208.
38.	文進, 謝瑜, 高曉鳳, 等. 美國颶風風險管理的循證評價及其對我國醫療風險管理的啟示——醫療風險系列研究之三. 中國循證醫學雜志, 2006, (3): 209-217.
39.	楊克虎, 馬彬, 田金徽, 等. 美國醫療風險監測預警機制現狀及績效的循證評價. 中國循證醫學雜志, 2006, (6): 439-450.
40.	馬彬, 楊克虎, 劉雅莉, 等. 英國醫療風險監管體系的循證評價及其對我國醫療風險管理的啟示——關注病人安全, 預防醫療差錯, 提高醫療質量. 中國循證醫學雜志, 2006, (7): 514-522.
41.	劉雅莉, 景濤, 田金徽, 等. 新西蘭醫療風險防范及監管機制現狀的循證評價——完善訴訟體系,規范醫療行為, 防范醫療風險. 中國循證醫學雜志, 2006, (9): 673-681.
42.	田金徽, 楊克虎, 馬彬, 等. 加拿大醫療風險監測預警機制的循證評價——整合全國衛生資源,建立病人安全體系. 中國循證醫學雜志, 2006, (12): 897-904.
43.	?楊克虎, 田金徽, 段明友, 等. 瑞典醫療風險監管體系的循證評價. 中國醫院管理, 2007, (3): 21-24.
44.	?楊克虎, 劉雅莉, 田金徽, 等. 澳大利亞醫療風險監管現狀及措施的循證評價. 中國醫院管理, 2007, (10): 62-65.
45.	John Naisbitt. Megatrends: Ten New Directions transforming Our Lives. 1982. Warner Books Inc. New York, p: 24.
46.	Simpson RL. Nursing informatics core competencies. Nurs Manage,1994, 25(5):18, 20.
47.	李幼平, 王莉, 文進. 注重證據, 循證決策. 中國循證醫學雜志, 2008, 8(1): 1-3.
48.	"Mad cows and ecstasy: chance and choice in an evidence-based society". Journal of the Royal Statistical Association, Series A 159(3): 367-383.
49.	Coomarasamy A, Khan KS. What is the evidence that postgraduate teaching in evidence based medicine changes anything A systematic review. BMJ, 2004, 329(7473): 1017.
50.	萬學紅, 張曉蘭. 醫學教育的循證研究. 中國循證醫學雜志, 2006, 6(5): 318-320.
51.	Eldredge J. Do Clinical Librarians Matter The First Randomized Controlled Trial? in Librarianshi p. Evidence Based Library and Information Practice, 2007, 2(4): 84-87.
52.	何奔. 實踐的“試金石”——2007年他汀循證證據回顧. 中國醫學論壇報, 2008, 34(3). 2008-01-17.

1. McCol l A, Smith H,White P,et al .General practitioner’s perceptions of the route to evidence based medicine: a questionnaire survey. BMJ, 1998, 316(7128): 361-365.
2. Guyatt G, Meade M,Jaeschke R,et al. Practitioners of evidence based care: not all clinicians need to appraise evidence from scratch but all need some skills. BMJ, 2000, 320(7240): 954-955.
3. Glasziou P, Vandenbroucke JP, Chalmers I. assessing the qual ity of research. BMJ, 2004, 328(7430): 39-41.
4. Campbell DT, Stanley JC. Experimental and quasi-experimental designs for Research.Chicago, IL: Rand McNally College, 1963.
5. Chalmers I, Hedges L, Cooper H. A brief history of research synthesis. Evaluation & the health professions, 2002, 25(1): 12-37.
6. Canadian Task Force on the Periodic Health Examination: The periodic health examination. CMAJ, 1979, 121(19): 1193-1254.
7. Schünemann HJ, Best D, Vist G, et al. Letters, numbers, symbols and words: how to communicate grades of evidence and recommendations. CMAJ, 2003, 169(7): 677-680.
8. Atkins D, Best D, Briss PA, et al. Grading quality of evidence and strength of recommendations. BMJ, 2004, 328(7454): 1490-1494.
9. Goldbloom R. Weighing the evidence: the Canadian experience. Am J Clin Nutr, 1997, 65(2 suppl): 584S-586S.
10. Atkins D, Eccles M, Flottorp S. Systems for grading the quality of evidence and the strength of recommendations I: Critical appraisal of existing approaches. BMC Health Serv Res, 2004, 4(1): 38.
11. Sackett DL. Rules of evidence and cl inical recommendations on the use of antithrombotic agents. Chest, 1986, 89(2 Suppl): 2S-3S.
12. Sackett DL. Rules of evidence and cl inical recommendations on the use of antithrombotic agents. Archives Int Med, 1986, 146(3): 464-465.
13. Guyatt GH,Sackett DL,Sinclair JC,et al .Users’ guides to the medical literature.IX. A method for grading health care recommendations. Evidence-Based Medicine Working Group. JAMA, 1995, 274(22): 1800-1804.
14. Sackett DL. Rules of evidence and cl inical recommendations on the use of antithrombotic agents. Chest, 1989, 95(2): 2S-4S.
15. Cook DJ, Guyatt GH, Laupacis A,et al. Rules of evidence and cl inical recommendations on the use of antithrombotic agents. Chest, 1992, 102(4): 305S-311S.
16. Cook DJ, Guyatt GH, Laupacis A, et al. Clinical recommendations using levels of evidence for antithrombotic agents. Chest, 1995, 108(4): 227S-230S.
17. Guyatt GH, Cook DJ, Sackett DL, et al. Grades of recommendation for antithrombotic agents. Chest, 1998, 114(5 Suppl): 441S-444S.
18. Guyatt G, Schünemann H, Cook D,et al . Grades of Recommendation for Antithrombotic Agents. Chest, 2001, 119(1): 3S-7S.
19. Guyatt G, Gutterman D, Baumann MH, et al. Grading strength of recommendations and quality of evidence in clinical guidel ines: report from an american college of chest physicians task force. Chest, 2006, 129(1): 174-181.
20. http://www.inclen.org/history.html.
21. 陳潔. 醫學技術評估. 上海: 上海醫科大學出版社. 1996.
22. Cochrane A. Effectiveness and Efficiency: Random Reflections on Health Services. London: Nuffield Provincial Hospitals Trust, 1972.
23. Guyatt GH. 循證醫學的五個發展方向. 中國循證醫學雜志, 2006, 6(3): 175-161.
24. Cinical Practice Guideline No.1: acute pain management: operative or medical procedures and trauma. Rockville (MD): US Department of Health and Human Services. Agency for Health Care Pol icy and Research; 1993. AHCPR Publication No. 92-0023.
25. http://www.ncbi.nlm.nih.gov/books/bv.fcgi?rid=hstat6.table.928626 Eccles M, Clapp Z, Grimshaw J, et al. Russell I: North of England evidence based guidelines development project: methods of guidel ine development. BMJ, 1996, 312(7033): 760-762.
26. Harbour R, Miller J. A new system for grading recommendations in evidence based guidelines. BMJ, 2001, 323(7308): 334-336.
27. Van Tulder W, Koes W, Bouter M. Conservative treatment of acute and chronic nonspecific low back pain. A systematic review of randomized controlled trials of the most common interventions. Spine, 1997, 22(18): 2128-2156.
28. Working Party for Guidelines for the Management of Heavy Menstrual Bleeding.An evidence-based guideline for the management of heavy menstrual bleeding. N Z Med J,1999, 112(1088): 174-177.
29. National Health and Medical Research Council (NHMRC). How to Use the Evidence: Assessment and Appl ication of Scientific Evidence. Canberra, Austral ia: NHMRC; 2000.
30. http://www.cebm.net/levels_of_evidence.asp.
31. 李幼平, 主編. 循證醫學. 第1版. 北京: 高等教育出版社.
32. http://www.gradeworkinggroup.org/about_us.htm.
33. http://library.downstate.edu/ebmdos/2100.htm.
34. Aragon CL, Budsberg SC. Applications of Evidence-Based Medicine: Cranial Cruciate Ligament Injury Repair in the Dog Veterinary Surgery. 34(2): 93–98.
35. 李幼平, 陶鐵軍, 孫丁, 等. 我國專科醫師分類研究初探. 中國循證醫學雜志, 2004, 4(3): 173-180.
36. 謝瑜, 文進, 高曉鳳, 等. 國外航空風險管理方法及績效的循證評價——醫療風險系列研究之一. 中國循證醫學雜志, 2006, 6(2): 131-138.
37. 高曉鳳,謝瑜,文進, 等.我國煤礦業風險管理現狀的循證評價——醫療風險系列研究之二. 中國循證醫學雜志, 2006, (3): 202-208.
38. 文進, 謝瑜, 高曉鳳, 等. 美國颶風風險管理的循證評價及其對我國醫療風險管理的啟示——醫療風險系列研究之三. 中國循證醫學雜志, 2006, (3): 209-217.
39. 楊克虎, 馬彬, 田金徽, 等. 美國醫療風險監測預警機制現狀及績效的循證評價. 中國循證醫學雜志, 2006, (6): 439-450.
40. 馬彬, 楊克虎, 劉雅莉, 等. 英國醫療風險監管體系的循證評價及其對我國醫療風險管理的啟示——關注病人安全, 預防醫療差錯, 提高醫療質量. 中國循證醫學雜志, 2006, (7): 514-522.
41. 劉雅莉, 景濤, 田金徽, 等. 新西蘭醫療風險防范及監管機制現狀的循證評價——完善訴訟體系,規范醫療行為, 防范醫療風險. 中國循證醫學雜志, 2006, (9): 673-681.
42. 田金徽, 楊克虎, 馬彬, 等. 加拿大醫療風險監測預警機制的循證評價——整合全國衛生資源,建立病人安全體系. 中國循證醫學雜志, 2006, (12): 897-904.
43. ?楊克虎, 田金徽, 段明友, 等. 瑞典醫療風險監管體系的循證評價. 中國醫院管理, 2007, (3): 21-24.
44. ?楊克虎, 劉雅莉, 田金徽, 等. 澳大利亞醫療風險監管現狀及措施的循證評價. 中國醫院管理, 2007, (10): 62-65.
45. John Naisbitt. Megatrends: Ten New Directions transforming Our Lives. 1982. Warner Books Inc. New York, p: 24.
46. Simpson RL. Nursing informatics core competencies. Nurs Manage,1994, 25(5):18, 20.
47. 李幼平, 王莉, 文進. 注重證據, 循證決策. 中國循證醫學雜志, 2008, 8(1): 1-3.
48. "Mad cows and ecstasy: chance and choice in an evidence-based society". Journal of the Royal Statistical Association, Series A 159(3): 367-383.
49. Coomarasamy A, Khan KS. What is the evidence that postgraduate teaching in evidence based medicine changes anything A systematic review. BMJ, 2004, 329(7473): 1017.
50. 萬學紅, 張曉蘭. 醫學教育的循證研究. 中國循證醫學雜志, 2006, 6(5): 318-320.
51. Eldredge J. Do Clinical Librarians Matter The First Randomized Controlled Trial? in Librarianshi p. Evidence Based Library and Information Practice, 2007, 2(4): 84-87.
52. 何奔. 實踐的“試金石”——2007年他汀循證證據回顧. 中國醫學論壇報, 2008, 34(3). 2008-01-17.

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醫學研究中證據分級和推薦強度的演進

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《中國循證醫學雜志》

醫學研究中證據分級和推薦強度的演進

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