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工作組

Corresponding?author：

Keywords：

GRADE**; PICO***; 患者重要結果; 替代指標; 指南制定; 證據質量; 間接性

DOI：

10.7507/1672-2531.20110077

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GRADE要求明確說明相關的背景、人群、干預措施和對照，同時要求不論研究結果能否形成證據，均需詳述所有重要結果。對某一特定管理問題，人群、干預措施及結果應在不同研究間足夠類似，才能認為得到相似的效應量合乎情理。指南制定者在收集證據前應先詳細說明各結局的相對重要性，同樣地，證據總結完成時也需要詳細說明這一點。考慮到替代結局的重要性，對采用替代指標描述且對患者很重要的結局，作者應評估其重要性，并進而降低這種間接結果的證據質量等級。

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工作組. 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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