GRADE Guidelines: 2. Framing the Question and Deciding on Important Outcomes△_Chinese Journal of Evidence-Based Medicine

Authors：

Gordon H. Guyatt , Andrew D. Oxman , Regina Kunz , David Atkins , Jan Brozek , Gunn Vist , Philip Alderson , Paul Glasziou , Yngve FalckYtter , Holger J. Schnemann , 代表GRADE工作组

Corresponding author：

Keywords：

GRADE**; PICO***; 患者重要结果; 替代指标; 指南制定; 证据质量; 间接性

DOI：

10.7507/1672-2531.20110077

Video：

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GRADE要求明确说明相关的背景、人群、干预措施和对照，同时要求不论研究结果能否形成证据，均需详述所有重要结果。对某一特定管理问题，人群、干预措施及结果应在不同研究间足够类似，才能认为得到相似的效应量合乎情理。指南制定者在收集证据前应先详细说明各结局的相对重要性，同样地，证据总结完成时也需要详细说明这一点。考虑到替代结局的重要性，对采用替代指标描述且对患者很重要的结局，作者应评估其重要性，并进而降低这种间接结果的证据质量等级。

Citation： Gordon H. Guyatt,Andrew D. Oxman,Regina Kunz,David Atkins,Jan Brozek,Gunn Vist,Philip Alderson,Paul Glasziou,Yngve FalckYtter,Holger J. Schnemann,代表GRADE工作组. GRADE Guidelines: 2. Framing the Question and Deciding on Important Outcomes△. Chinese Journal of Evidence-Based Medicine, 2011, 11(4): 446-450. doi: 10.7507/1672-2531.20110077 Copy

1.	1 Schunemann HJ, Cook D, Guyatt G. Methodology for antithrombotic and thrombolytic therapy guideline development: American College of Chest Physicians Evidence-based Clinical Practice Guidelines (8th Edition). Chest , 2008, 133(6 Suppl): 113S-122S.
2.	CAPRIE Steering Committee. A randomised, blinded, trial of clopidogrel versus aspirin in patients at risk of ischaemic events (CAPRIE). Lancet , 1997.
3.	Letelier LM, Udol K, Ena J, et al . Effectiveness of amiodarone for conversion of atrial fibrillation to sinus rhythm: a meta-analysis. Arch Intern Med , 2003, 163(7): 777-785.
4.	Guyatt G, Oxman AD, Kunz R, et al . Grade Guidelines: 6. Rating the quality of evidence: Inconsistency. Journal of Clnical Epidemiology , 2010.
5.	Eikelboom J, Guyatt G, Hirsh J. Guidelines for anticoagulant use in acute coronary syndromes. Lancet , 2008, 371(9624): 1559-1561.
6.	Furukawa TA, Guyatt GH, Griffith LE. Can we individualize the ‘number needed to treat’? An empirical study of summary effect measures in meta-analyses. Int J Epidemiol , 2002, 31(1): 72-76.
7.	Schmid, CH, Lau J, Mcintosh MW, et al . An empirical study of the effect of the control rate as a predictor of treatment efficacy in meta-analysis of clinical trials. Stat Med , 1998, 17(17): 1923-1942.
8.	Deeks JJ. Issues in the selection of a summary statistic for meta-analysis of clinical trials with binary outcomes. Stat Med , 2002, 21(11): 1575-1600.
9.	Singer DE, Albers GW, Dalen JE, et al . Antithrombotic therapy in atrial fibrillation: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition). Chest , 2008, 133(6 Suppl): 546S-592S.
10.	Bucher HC, Griffith LE, Guyatt GH. Effect of HMGcoA reductase inhibitors on stroke. A meta-analysis of randomized, controlled trials. Ann Intern Med , 1998, 128(2): 89-95.
11.	Bischoff-Ferrari HA, Willett WC, Wong JB, et al . Fracture prevention with vitamin D supplementation: a meta-analysis of randomized controlled trials. JAMA , 2005, 293(18): 2257-2264.
12.	Montori VM, Gandhi GY, Guyatt GH. Patient-important outcomes in diabetes--time for consensus. Lancet , 2007, 370(9593): 1104-1106.
13.	Gandhi GY. Murad MH, Fujiyoshi A, et al . Patient-important outcomes in registered diabetes trials. JAMA , 2008, 299(21): 2543-2549.
14.	Bucher H, Guyatt G, Cook D, et al . Surrogate outcomes. In: Guyatt G, et al, editors. The users’ guides to the medical literature: a manual for evidence-based clinical practice. New York, NY: McGraw-Hill; 2008.
15.	Lasser KE, Allen PD, Woolhandler SJ, et al . Timing of new black box warnings and withdrawals for prescription medications. JAMA , 2002, 287(17): 2215-2220.
16.	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.

1. 1 Schunemann HJ, Cook D, Guyatt G. Methodology for antithrombotic and thrombolytic therapy guideline development: American College of Chest Physicians Evidence-based Clinical Practice Guidelines (8th Edition). Chest , 2008, 133(6 Suppl): 113S-122S.
2. CAPRIE Steering Committee. A randomised, blinded, trial of clopidogrel versus aspirin in patients at risk of ischaemic events (CAPRIE). Lancet , 1997.
3. Letelier LM, Udol K, Ena J, et al . Effectiveness of amiodarone for conversion of atrial fibrillation to sinus rhythm: a meta-analysis. Arch Intern Med , 2003, 163(7): 777-785.
4. Guyatt G, Oxman AD, Kunz R, et al . Grade Guidelines: 6. Rating the quality of evidence: Inconsistency. Journal of Clnical Epidemiology , 2010.
5. Eikelboom J, Guyatt G, Hirsh J. Guidelines for anticoagulant use in acute coronary syndromes. Lancet , 2008, 371(9624): 1559-1561.
6. Furukawa TA, Guyatt GH, Griffith LE. Can we individualize the ‘number needed to treat’? An empirical study of summary effect measures in meta-analyses. Int J Epidemiol , 2002, 31(1): 72-76.
7. Schmid, CH, Lau J, Mcintosh MW, et al . An empirical study of the effect of the control rate as a predictor of treatment efficacy in meta-analysis of clinical trials. Stat Med , 1998, 17(17): 1923-1942.
8. Deeks JJ. Issues in the selection of a summary statistic for meta-analysis of clinical trials with binary outcomes. Stat Med , 2002, 21(11): 1575-1600.
9. Singer DE, Albers GW, Dalen JE, et al . Antithrombotic therapy in atrial fibrillation: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition). Chest , 2008, 133(6 Suppl): 546S-592S.
10. Bucher HC, Griffith LE, Guyatt GH. Effect of HMGcoA reductase inhibitors on stroke. A meta-analysis of randomized, controlled trials. Ann Intern Med , 1998, 128(2): 89-95.
11. Bischoff-Ferrari HA, Willett WC, Wong JB, et al . Fracture prevention with vitamin D supplementation: a meta-analysis of randomized controlled trials. JAMA , 2005, 293(18): 2257-2264.
12. Montori VM, Gandhi GY, Guyatt GH. Patient-important outcomes in diabetes--time for consensus. Lancet , 2007, 370(9593): 1104-1106.
13. Gandhi GY. Murad MH, Fujiyoshi A, et al . Patient-important outcomes in registered diabetes trials. JAMA , 2008, 299(21): 2543-2549.
14. Bucher H, Guyatt G, Cook D, et al . Surrogate outcomes. In: Guyatt G, et al, editors. The users’ guides to the medical literature: a manual for evidence-based clinical practice. New York, NY: McGraw-Hill; 2008.
15. Lasser KE, Allen PD, Woolhandler SJ, et al . Timing of new black box warnings and withdrawals for prescription medications. JAMA , 2002, 287(17): 2215-2220.
16. 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.

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