GRADE指南：Ⅳ. 證據質量分級——研究的局限性（偏倚風險）△_《中國循證醫學雜志》

作者：

Gordon H. Guyatt , Andrew D. Oxman , Gunn Vist , Regina Kunz , Jan Brozek , Pablo AlonsoCoello , Victor Montori , Elie A. Akl , Ben Djulbegovic , Yngve FalckYtter , Susan L.Norris , John W.Williams Jr. , David Atkins , Joerg Meerpohl , Holger J. Schnemann , 代表GRADE工作組

關鍵詞：

GRADE** 證據質量偏倚風險估計值的可信度盲法分配隱藏

DOI：

10.7507/1672-2531.20110079

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在GRADE方法中，若多數相關證據來自高偏倚風險的研究，則起初被定為高質量證據的隨機試驗和低質量證據的觀察性研究均有可能被降低質量等級。隨機試驗已確定的局限性包括：未進行分配隱藏、未實施盲法、未報告失訪情況及未恰當考慮意向性治療原則。最近提出的局限性包括：因明顯獲益而早期終止試驗和基于結果選擇性報告結局。觀察性研究的主要局限性包括使用不合適的對照及未能充分調整預后的不平衡。偏倚風險可因不同結果而異（如全死因死亡率的失訪遠少于生命質量的失訪），許多系統評價都容易忽略這一點。在決定是否因偏倚風險而降低質量等級時，不管是隨機試驗還是觀察性研究，作者不應采用對各個研究取平均值的方法。相反，對任何單個結果，當同時存在高、低偏倚風險的研究時，則應考慮只納入較低偏倚風險的研究。

引用本文： Gordon H. Guyatt,Andrew D. Oxman,Gunn Vist,Regina Kunz,Jan Brozek,Pablo AlonsoCoello,Victor Montori,Elie A. Akl,Ben Djulbegovic,Yngve FalckYtter,Susan L.Norris,John W.Williams Jr.,David Atkins,Joerg Meerpohl,Holger J. Schnemann,代表GRADE工作組. GRADE指南：Ⅳ. 證據質量分級——研究的局限性（偏倚風險）△. 中國循證醫學雜志, 2011, 11(4): 456-463. doi: 10.7507/1672-2531.20110079 復制

1.	3 Vedula SS, Bero L, Scherer RW, et al . Outcome reporting in industry-sponsored trials of gabapentin for off-label use. N Engl J Med , 2009, 361(20): 1963-1971.
2.	The Users' Guides to the Medical Literature: A Manual for Evidence-Based Clinical Practice (2nd ed). In: Guyatt G, Rennie D, Meade M, Cook D, editors. 2nd ed. New York, NY: McGraw-Hill; 2008.
3.	Higgins JP, Altman D. Assessing the risk of bias in included studies. In: Higgins J, Green S, Editors. Cochrane Handbook for Systematic Reviews of Interventions 5.0.1. Chichester, UK: John Wiley & Sons: 2008.
4.	Mathieu S, Boutron I, Moher D, et al . Comparison of registered and published primary outcomes in randomized controlled trials. JAMA , 2009, 302: 977-984.
5.	Wood L, Egger M, Gluud LL, et al . Empirical evidence of bias in treatment effect estimates in controlled trials with different interventions and outcomes: meta-epidemiological study. BMJ , 2008, 336(7644): 601-605.
6.	Pocock SJ. When (not) to stop a clinical trial for benefit. JAMA , 2005, 294(17): 2228-2230.
7.	Pocock SJ, Hughes MD. Practical problems in interim analyses, with particular regard to estimation. Control Clin Trials , 1989, 10(4 Suppl): 209S-221S.
8.	Montori, VM, Devereaux PJ, Adhikari NK, et al . Randomized trials stopped early for benefit: a systematic review. JAMA , 2005, 294(17): 2203-2209.
9.	Bassler D, Briel M, Montori VM, et al . Stopping randomized trials early for benefit and estimation of treatment effects: systematic review and meta-regression analysis. JAMA , 2010, 303(12): 1180-1187.
10.	Furukawa TA, Watanabe N, Omori IM, et al . Association between unreported outcomes and effect size estimates in Cochrane meta-analyses. JAMA , 2007, 297(5): 468-670.
11.	Chan AW, Altman DG. Identifying outcome reporting bias in randomised trials on PubMed: review of publications and survey of authors. BMJ , 2005, 330(7494): 753.
12.	Chan AW, Hróbjartsson A, Haahr MT, et al . Empirical evidence for selective reporting of outcomes in randomized trials: comparison of protocols to published articles. JAMA , 2004, 291(20): 2457-2465.
13.	Chan AW, Krle?a-Jeri? K, Schmid I, et al . Outcome reporting bias in randomized trials funded by the Canadian Institutes of Health Research. CMAJ , 2004, 171(7): 735-740.
14.	Bolona ER, UragaMV, Haddad RM, et al . Testosterone use in men with sexual dysfunction: a systematic review and meta-analysis of randomized placebo-controlled trials. Mayo Clin Proc , 2007, 82(1): 20-28.
15.	Sinha M, Montori VM. Reporting bias and other biases affecting systematic reviews and meta-analyses: a methodological commentary. Expert Rev Pharmacoeconomics Outcomes Res , 2006, 6(1): 603-611.
16.	Deeks JJ, Dinnes J, D’Amico R, et al . Evaluating non-randomised intervention studies. Health Technol Assess , 2003, 7(27): iii-x, 1-173.
17.	West S, King V, Carey TS, et al . Systems to rate the strength of scientific evidence [Evidence report/technology assessment no 47]. AHRQ Publication No 02-E016. Rockville, MD: Agency for Healthcare Research and Quality; 2002.
18.	Proposed Evaluation Tools for COMPUS: assessment, November 29, 2005. Ottawa, Canada: Canadian Coordinating Of?ce for Health Technology; 2005.
19.	Sanderson S, Tatt ID, Higgins JP. Tools for assessing quality and susceptibility to bias in observational studies in epidemiology: a systematic review and annotated bibliography. Int J Epidemiol , 2007, 36(3): 666-676.
20.	Greer IA, Nelson-Piercy C. Low-molecular-weight heparins for thromboprophylaxis and treatment of venous thromboembolism in pregnancy: a systematic review of safety and efficacy. Blood , 2005, 106(2): 401-407.
21.	Sanson BJ, Lensing AW, Prins MH, et al . Safety of low-molecular-weight heparin in pregnancy: a systematic review. Thromb Haemost , 1999, 81(5): 668-672.
22.	Bowker SL, Majumdar SR, Veugelers P, et al . Increased cancer-related mortality for patients with type 2 diabetes who use sulfonylureas or insulin. Diabetes Care , 2006, 29(2): 254-258.
23.	Bracken MB, Shepard MJ, Collins WF Jr, et al . Methylprednisolone or naloxone treatment after acute spinal cord injury: 1-year follow-up data. Results of the second National Acute Spinal Cord Injury Study. J Neurosurg , 1992, 76(1): 23-31.
24.	Otani K, Abe H, Kadoya S. Beneficial effect of methylprednisolone sodium succinate in the treatment of acute spinal cord injury. Sekitsui Sekizui , 1994, 7: 633-647.
25.	Pointillart V, Petitjean ME, Wiart L, et al . Pharmacological therapy of spinal cord injury during the acute phase. Spinal Cord , 2000, 38(2): 71-76.
26.	Brophy JM, Joseph L, Rouleau JL. Beta-blockers in congestive heart failure. A Bayesian meta-analysis. Ann Intern Med , 2001, 134(7): 550-560.
27.	McIntosh H, Jones K. Chloroquine or amodiaquine combined with sulfadoxine-pyrimethamine for treating uncomplicated malaria. Cochrane Database Syst Rev , 2005, (4): CD000386.
28.	Gibson J, Waddell G. Surgical interventions for lumbar disc prolapse. Cochrane Database Syst Rev , 2007, (2)10. 1002/14651858. CD001350.
29.	Dobre D, van Jaarsveld CH, deJongste MJ, et al . The effect of beta-blocker therapy on quality of life in heart failure patients: a systematic review and meta-analysis. Pharmacoepidemiol Drug Saf , 2007, 16(2): 152-159.
30.	Moher D, Jadad AR, Nichol G, et al . Assessing the quality of randomized controlled trials: an annotated bibliography of scales and checklists. Control Clin Trials , 1995, 16(1): 62-73.
31.	Schulz KF, Chalmers I, Hayes RJ, et al . Empirical evidence of bias. Dimensions of methodological quality associated with estimates of treatment effects in controlled trials. JAMA , 1995, 273(5): 408-412.
32.	Emerson JD, Burdick E, Hoaglin DC, et al . An empirical study of the possible relation of treatment differences to quality scores in controlled randomized clinical trials. Control Clin Trials , 1990, 11(5): 339-352.
33.	Juni P, Witschi A, Bloch R, et al . The hazards of scoring the quality of clinical trials for meta-analysis. JAMA , 1999, 282(11): 1054-1060.
34.	Devereaux PJ, Choi PT, El-Dika S, et al . An observational study found that authors of randomized controlled trials frequently use concealment of randomization and blinding, despite the failure to report these methods. J Clin Epidemiol , 2004, 57(12): 1232-1236.
35.	Soares HP, Daniels S, Kumar A, et al . Bad reporting does not mean bad methods for randomised trials: observational study of randomised controlled trials performed by the Radiation Therapy Oncology Group. BMJ , 2004, 328(7430): 22-24.
36.	Alonso-Coello P, Zhou Q, Martinez-Zapata MJ, et al . Meta-analysis of flavonoids for the treatment of haemorrhoids. Br J Surg , 2006, 93(8): 909-920.
37.	Clarke M, Hopewell S, Juszczak E, et al . Compression stockings for preventing deep vein thrombosis in airline passengers. Cochrane Database Syst Rev , 2007, (3): CD004002.
38.	Geerts WH, Bergqvist D, Pineo GF, et al . Prevention of venous thromboembolism: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition). Chest , 2008, 133(6 Suppl): 381S-453S.

1. 3 Vedula SS, Bero L, Scherer RW, et al . Outcome reporting in industry-sponsored trials of gabapentin for off-label use. N Engl J Med , 2009, 361(20): 1963-1971.
2. The Users' Guides to the Medical Literature: A Manual for Evidence-Based Clinical Practice (2nd ed). In: Guyatt G, Rennie D, Meade M, Cook D, editors. 2nd ed. New York, NY: McGraw-Hill; 2008.
3. Higgins JP, Altman D. Assessing the risk of bias in included studies. In: Higgins J, Green S, Editors. Cochrane Handbook for Systematic Reviews of Interventions 5.0.1. Chichester, UK: John Wiley & Sons: 2008.
4. Mathieu S, Boutron I, Moher D, et al . Comparison of registered and published primary outcomes in randomized controlled trials. JAMA , 2009, 302: 977-984.
5. Wood L, Egger M, Gluud LL, et al . Empirical evidence of bias in treatment effect estimates in controlled trials with different interventions and outcomes: meta-epidemiological study. BMJ , 2008, 336(7644): 601-605.
6. Pocock SJ. When (not) to stop a clinical trial for benefit. JAMA , 2005, 294(17): 2228-2230.
7. Pocock SJ, Hughes MD. Practical problems in interim analyses, with particular regard to estimation. Control Clin Trials , 1989, 10(4 Suppl): 209S-221S.
8. Montori, VM, Devereaux PJ, Adhikari NK, et al . Randomized trials stopped early for benefit: a systematic review. JAMA , 2005, 294(17): 2203-2209.
9. Bassler D, Briel M, Montori VM, et al . Stopping randomized trials early for benefit and estimation of treatment effects: systematic review and meta-regression analysis. JAMA , 2010, 303(12): 1180-1187.
10. Furukawa TA, Watanabe N, Omori IM, et al . Association between unreported outcomes and effect size estimates in Cochrane meta-analyses. JAMA , 2007, 297(5): 468-670.
11. Chan AW, Altman DG. Identifying outcome reporting bias in randomised trials on PubMed: review of publications and survey of authors. BMJ , 2005, 330(7494): 753.
12. Chan AW, Hróbjartsson A, Haahr MT, et al . Empirical evidence for selective reporting of outcomes in randomized trials: comparison of protocols to published articles. JAMA , 2004, 291(20): 2457-2465.
13. Chan AW, Krle?a-Jeri? K, Schmid I, et al . Outcome reporting bias in randomized trials funded by the Canadian Institutes of Health Research. CMAJ , 2004, 171(7): 735-740.
14. Bolona ER, UragaMV, Haddad RM, et al . Testosterone use in men with sexual dysfunction: a systematic review and meta-analysis of randomized placebo-controlled trials. Mayo Clin Proc , 2007, 82(1): 20-28.
15. Sinha M, Montori VM. Reporting bias and other biases affecting systematic reviews and meta-analyses: a methodological commentary. Expert Rev Pharmacoeconomics Outcomes Res , 2006, 6(1): 603-611.
16. Deeks JJ, Dinnes J, D’Amico R, et al . Evaluating non-randomised intervention studies. Health Technol Assess , 2003, 7(27): iii-x, 1-173.
17. West S, King V, Carey TS, et al . Systems to rate the strength of scientific evidence [Evidence report/technology assessment no 47]. AHRQ Publication No 02-E016. Rockville, MD: Agency for Healthcare Research and Quality; 2002.
18. Proposed Evaluation Tools for COMPUS: assessment, November 29, 2005. Ottawa, Canada: Canadian Coordinating Of?ce for Health Technology; 2005.
19. Sanderson S, Tatt ID, Higgins JP. Tools for assessing quality and susceptibility to bias in observational studies in epidemiology: a systematic review and annotated bibliography. Int J Epidemiol , 2007, 36(3): 666-676.
20. Greer IA, Nelson-Piercy C. Low-molecular-weight heparins for thromboprophylaxis and treatment of venous thromboembolism in pregnancy: a systematic review of safety and efficacy. Blood , 2005, 106(2): 401-407.
21. Sanson BJ, Lensing AW, Prins MH, et al . Safety of low-molecular-weight heparin in pregnancy: a systematic review. Thromb Haemost , 1999, 81(5): 668-672.
22. Bowker SL, Majumdar SR, Veugelers P, et al . Increased cancer-related mortality for patients with type 2 diabetes who use sulfonylureas or insulin. Diabetes Care , 2006, 29(2): 254-258.
23. Bracken MB, Shepard MJ, Collins WF Jr, et al . Methylprednisolone or naloxone treatment after acute spinal cord injury: 1-year follow-up data. Results of the second National Acute Spinal Cord Injury Study. J Neurosurg , 1992, 76(1): 23-31.
24. Otani K, Abe H, Kadoya S. Beneficial effect of methylprednisolone sodium succinate in the treatment of acute spinal cord injury. Sekitsui Sekizui , 1994, 7: 633-647.
25. Pointillart V, Petitjean ME, Wiart L, et al . Pharmacological therapy of spinal cord injury during the acute phase. Spinal Cord , 2000, 38(2): 71-76.
26. Brophy JM, Joseph L, Rouleau JL. Beta-blockers in congestive heart failure. A Bayesian meta-analysis. Ann Intern Med , 2001, 134(7): 550-560.
27. McIntosh H, Jones K. Chloroquine or amodiaquine combined with sulfadoxine-pyrimethamine for treating uncomplicated malaria. Cochrane Database Syst Rev , 2005, (4): CD000386.
28. Gibson J, Waddell G. Surgical interventions for lumbar disc prolapse. Cochrane Database Syst Rev , 2007, (2)10. 1002/14651858. CD001350.
29. Dobre D, van Jaarsveld CH, deJongste MJ, et al . The effect of beta-blocker therapy on quality of life in heart failure patients: a systematic review and meta-analysis. Pharmacoepidemiol Drug Saf , 2007, 16(2): 152-159.
30. Moher D, Jadad AR, Nichol G, et al . Assessing the quality of randomized controlled trials: an annotated bibliography of scales and checklists. Control Clin Trials , 1995, 16(1): 62-73.
31. Schulz KF, Chalmers I, Hayes RJ, et al . Empirical evidence of bias. Dimensions of methodological quality associated with estimates of treatment effects in controlled trials. JAMA , 1995, 273(5): 408-412.
32. Emerson JD, Burdick E, Hoaglin DC, et al . An empirical study of the possible relation of treatment differences to quality scores in controlled randomized clinical trials. Control Clin Trials , 1990, 11(5): 339-352.
33. Juni P, Witschi A, Bloch R, et al . The hazards of scoring the quality of clinical trials for meta-analysis. JAMA , 1999, 282(11): 1054-1060.
34. Devereaux PJ, Choi PT, El-Dika S, et al . An observational study found that authors of randomized controlled trials frequently use concealment of randomization and blinding, despite the failure to report these methods. J Clin Epidemiol , 2004, 57(12): 1232-1236.
35. Soares HP, Daniels S, Kumar A, et al . Bad reporting does not mean bad methods for randomised trials: observational study of randomised controlled trials performed by the Radiation Therapy Oncology Group. BMJ , 2004, 328(7430): 22-24.
36. Alonso-Coello P, Zhou Q, Martinez-Zapata MJ, et al . Meta-analysis of flavonoids for the treatment of haemorrhoids. Br J Surg , 2006, 93(8): 909-920.
37. Clarke M, Hopewell S, Juszczak E, et al . Compression stockings for preventing deep vein thrombosis in airline passengers. Cochrane Database Syst Rev , 2007, (3): CD004002.
38. Geerts WH, Bergqvist D, Pineo GF, et al . Prevention of venous thromboembolism: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition). Chest , 2008, 133(6 Suppl): 381S-453S.

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GRADE指南：Ⅳ. 證據質量分級——研究的局限性（偏倚風險）△

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