Rationales, Methods, Challenges and Development Tendency of Using GRADE in Systematic Reviews of Diagnostic Accuracy Tests_Chinese Journal of Evidence-Based Medicine

Authors：

 CHENYao-long ^1,2,3 ^# ,  YAOLiang ^1,2,3 ^# , DULiang ⁴ , ZENGXian-tao ⁵ , WEIDang ^1,2,3 , WANGQi ^1,2,3 , WANGXiao-qin ^1,2,3 ,  YANGKe-hu ^1,2,3

1. Key Laboratory of Evidence-based Medicine and Knowledge Translation of Gansu Province, Lanzhou 730000, China;
2. Evidence-based Medicine Center, School of Basic Medical Sciences, Lanzhou University, Lanzhou 730000, China;
3. Chinese GRADE Center, Lanzhou University, Lanzhou 730000, China;
4. Chinese Evidence-Based Medicine Center, West China Hospital, Sichuan University, Chengdu 610041, China;
5. Center for Evidence-based Medicine and Translational Research, Zhongnan Hospital, Wuhan University, Wuhan 430071, China;

Corresponding author：

YANGKe-hu, Email: yangkh@lzu.edu.cn

Keywords：

GRADE; Grading evidence; Systematic review; Diagnostic test

DOI：

10.7507/1672-2531.20140225

Video：

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Depending on different designs of original studies, systematic reviews of diagnostic studies could be categorized into two kinds:one is based on diagnostic randomized controlled trials, of which the GRADE rating approach is similar to that of interventional systematic reviews; and the other is based on diagnostic accuracy tests, of which the GRADE rating approach is introduced in this article. This article explains the application of GRADE in systematic reviews of diagnostic accuracy tests mainly from the angle of theoretical analysis, including rationales, methods, and challenges.

Citation： CHENYao-long, YAOLiang, DULiang, ZENGXian-tao, WEIDang, WANGQi, WANGXiao-qin, YANGKe-hu. Rationales, Methods, Challenges and Development Tendency of Using GRADE in Systematic Reviews of Diagnostic Accuracy Tests. Chinese Journal of Evidence-Based Medicine, 2014, 14(11): 1402-1406. doi: 10.7507/1672-2531.20140225 Copy

1.	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.
2.	Guyatt GH, Oxman AD, Vist GE, et al. Rating quality of evidence and strength of recommendations:GRADE:an emerging consensus on rating quality of evidence and strength of recommendations. BMJ, 2008, 336(7650):924.
3.	Higgins JPT, Green S (editors). Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0[updated March 2011]. The Cochrane Collaboration, 2011. Available at:www.cochrane-handbook.org.
4.	Macaskill P, Gatsonis C, Deeks J, et al. Cochrane handbook for systematic reviews of diagnostic test accuracy. Version 0.9. 0. London:The Cochrane Collaboration, 2010.
5.	陈耀龙, 杨克虎, 姚亮, 等. GRADE系统方法学进展.中国循证儿科杂志, 2013, 8(1):1-2.
6.	Schünemann AHJ, Oxman AD, Brozek J, et al. GRADE:grading quality of evidence and strength of recommendations for diagnostic tests and strategies. BMJ, 2008, 336(7653):1106-1110.
7.	Gopalakrishna G, Mustafa RA, Davenport C, et al. Applying Grading of Recommendations Assessment, Development and Evaluation (GRADE) to diagnostic tests was challenging but doable. J Clin Epidemiol, 2014, 67(7):760-768.
8.	Siontis KC, Siontis G, Contopoulos-Ioannidis DG, et al. Diagnostic tests often fail to lead to changes in patient outcomes. J Clin Epidemiol, 2014, 67(6):612-621.
9.	Hsu J, Brożek J L, Terracciano L, et al. Application of GRADE:Making evidence-based recommendations about diagnostic tests in clinical practice guidelines. Implementation Science, 2011, 6(1):62.
10.	GRADE工作组网站.[2014-6-6]. Available at:http://www.gradeworkinggroup.org/.
11.	Whiting P, Rutjes AW, Reitsma JB, et al. The development of QUADAS:a tool for the quality assessment of studies of diagnostic accuracy included in systematic reviews. BMC Med Res Methodol, 2003, 3:25.
12.	Whiting PF, Rutjes AW, Westwood ME, et al. QUADAS-2:a revised tool for the quality assessment of diagnostic accuracy studies. Ann Intern Med, 2011, 155(8):529-36.
13.	Biesheuvel CJ, Grobbee DE, Moons KG. Distraction from randomization in diagnostic research. Ann Epidemiol, 2006, 16(7):540-544.
14.	Lijmer JG, Bossugyt PM. Various randomized designs can be used to evaluated medical tests. J Clin Epidemiol, 2009, 62(4):364-373.
15.	Guyatt GH, Oxman AD, Vist GE, et al. GRADE:an emerging consensus on rating quality of evidence and strength of recommendations. BMJ, 2008, 336(7650):924-926.
16.	陈耀龙, 李幼平, 杜亮, 等.医学研究中证据分级和推荐强度的演进.中国循证医学杂志, 2008, 8(2):127-133.
17.	Brozek JL, Akl EA, Jaeschke R, et al. Grading quality of evidence and strength of recommendations in clinical practice guidelines:Part 2 of 3. The GRADE approach to grading quality of evidence about diagnostic tests and strategies. Allergy, 2009, 64(8):1109-1116.
18.	Bossuyt PM, Lijmer JG, Mol BW. Randomised comparisons of medical tests:sometimes invalid, not always efficient. Lancet, 2000, 356(9244):1844-1847.
19.	陈耀龙, 姚亮, 杜亮, 等. GRADE在系统评价中应用的必要性及注意事项.中国循证医学杂志, 2013, 13(12):1401-1404.
20.	Lord SJ, Irwig L, Simes RJ. When is measuring sensitivity and specificity sufficient to evaluate a diagnostic test, and when do we need randomized trials? Ann Intern Med, 2006, 144(11):850-855.
21.	廖晓阳, 金成勇.如何在诊断性试验研究中正确应用有关测量指标.华西医学, 2000, 15(2):146-147.
22.	验证疗效网站.[2014-6-6]. Available at:http://cn.testingtreatments.org/.
23.	邬兰, 张永, 曾宪涛. QUADAS-2在诊断准确性研究的质量评价工具中的应用.湖北医药学院学报, 2013, 32(3):201-208.
24.	Van der Windt DA, Simons E, Riphagen Ⅱ, Ammendolia C, et al. Physical examination for lumbar radiculopathy due to disc herniation in patients with low-back pain. Cochrane Database Syst Rev, 2010, (2):CD007431.
25.	Fletcher R. Carcinoembryonic antigen. Ann Intern Med, 1986, 104(1):66-73.
26.	Hlatky M, Pryor D, Harrell JR F, et al. Factors affecting sensitivity and specificity of exercise electrocardiography. Multivariable analysis. Am J Med, 1984, 77(1):64-71.
27.	Levy D, Labib S, Anderson K, et al. Determinants of sensitivity and specificity of electrocardiographic criteria for left ventricular hypertrophy. Circulation, 1990, 81(3):815-820.
28.	田金徽, Fujian Song, 李伦, 等.间接比较方法简介.中国循证医学杂志, 2014, 14(3):365-368.
29.	Guyatt GH, Oxman AD, Kunz R, 等. GRADE指南:Ⅶ.证据质量评价——不一致性.中国循证医学杂志, 2011, 11(12):1444-1451.
30.	Buderer NM. Statistical methodology:I. Incorporating the prevalence ofdisease into the sample size calculation for sensitivity and specificity. Acad Emerg Med, 1996, 3(9):895-900.
31.	Carley S, Dosman S, Jones SR. Simple nomograms to calculate sample size in diagnostic studies. Emerg Med J, 2005, 22(3):180-181.
32.	Flahault A, Cadilhac M, Thomas G. Sample size calculation should be performed for design accuracy in diagnostic test studies. J Clin Epidemiol, 2005, 58(8):859-862.
33.	Guyatt G, Oxman A, Montori V, et al. GRADE指南:Ⅴ.证据质量评价——发表偏倚.中国循证医学杂志, 2011, 11(12):1430-1434.
34.	Begg CB, Berlin JA. Publication bias:A problem in interpreting medical data. Journal of the Royal Statistical Society, Series A, 1988, 151(3):419-463.
35.	Begg CB, Mazumdar M. Operating characteristics of a rank correlation test for publication bias. Biometrics, 1994, 50(4):1088-1101.
36.	Egger M, Smith GD, Schneider M, et al. Bias in meta-analysis detected by a simple, graphical test. BMJ, 1997, 315(7109):629-634.
37.	Deeks JJ, Macaskill P, Irwig L:The performance of tests of publication bias and other sample size effects in systematic reviews of diagnostic test accuracy was assessed. J Clin Epidemiol, 2005, 58(9):882-893.
38.	Macaskill P, Walter SD, Irwig L. A comparison of methods to detect publication bias in meta-analysis. Stat Med, 2001, 20(4):641-654.
39.	Van Enst WA, Ochodo E, Scholten RJ, et al. Investigation of publication bias in meta-analyses of diagnostic test accuracy:a meta-epidemiological study. BMC Med Res Methodol, 2014, 14(1):70.
40.	Terrin N, Schmid C H, Lau J. In an empirical evaluation of the funnel plot, researchers could not visually identify publication bias. Journal of clinical epidemiology, 2005, 58(9):894-901.
41.	杨书, 李婷婷, 刘新.应用漏斗图识别发表性偏倚的效率研究.成都医学院学报, 2007, 2(1):33-34.

1. 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.
2. Guyatt GH, Oxman AD, Vist GE, et al. Rating quality of evidence and strength of recommendations:GRADE:an emerging consensus on rating quality of evidence and strength of recommendations. BMJ, 2008, 336(7650):924.
3. Higgins JPT, Green S (editors). Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0[updated March 2011]. The Cochrane Collaboration, 2011. Available at:www.cochrane-handbook.org.
4. Macaskill P, Gatsonis C, Deeks J, et al. Cochrane handbook for systematic reviews of diagnostic test accuracy. Version 0.9. 0. London:The Cochrane Collaboration, 2010.
5. 陈耀龙, 杨克虎, 姚亮, 等. GRADE系统方法学进展.中国循证儿科杂志, 2013, 8(1):1-2.
6. Schünemann AHJ, Oxman AD, Brozek J, et al. GRADE:grading quality of evidence and strength of recommendations for diagnostic tests and strategies. BMJ, 2008, 336(7653):1106-1110.
7. Gopalakrishna G, Mustafa RA, Davenport C, et al. Applying Grading of Recommendations Assessment, Development and Evaluation (GRADE) to diagnostic tests was challenging but doable. J Clin Epidemiol, 2014, 67(7):760-768.
8. Siontis KC, Siontis G, Contopoulos-Ioannidis DG, et al. Diagnostic tests often fail to lead to changes in patient outcomes. J Clin Epidemiol, 2014, 67(6):612-621.
9. Hsu J, Brożek J L, Terracciano L, et al. Application of GRADE:Making evidence-based recommendations about diagnostic tests in clinical practice guidelines. Implementation Science, 2011, 6(1):62.
10. GRADE工作组网站.[2014-6-6]. Available at:http://www.gradeworkinggroup.org/.
11. Whiting P, Rutjes AW, Reitsma JB, et al. The development of QUADAS:a tool for the quality assessment of studies of diagnostic accuracy included in systematic reviews. BMC Med Res Methodol, 2003, 3:25.
12. Whiting PF, Rutjes AW, Westwood ME, et al. QUADAS-2:a revised tool for the quality assessment of diagnostic accuracy studies. Ann Intern Med, 2011, 155(8):529-36.
13. Biesheuvel CJ, Grobbee DE, Moons KG. Distraction from randomization in diagnostic research. Ann Epidemiol, 2006, 16(7):540-544.
14. Lijmer JG, Bossugyt PM. Various randomized designs can be used to evaluated medical tests. J Clin Epidemiol, 2009, 62(4):364-373.
15. Guyatt GH, Oxman AD, Vist GE, et al. GRADE:an emerging consensus on rating quality of evidence and strength of recommendations. BMJ, 2008, 336(7650):924-926.
16. 陈耀龙, 李幼平, 杜亮, 等.医学研究中证据分级和推荐强度的演进.中国循证医学杂志, 2008, 8(2):127-133.
17. Brozek JL, Akl EA, Jaeschke R, et al. Grading quality of evidence and strength of recommendations in clinical practice guidelines:Part 2 of 3. The GRADE approach to grading quality of evidence about diagnostic tests and strategies. Allergy, 2009, 64(8):1109-1116.
18. Bossuyt PM, Lijmer JG, Mol BW. Randomised comparisons of medical tests:sometimes invalid, not always efficient. Lancet, 2000, 356(9244):1844-1847.
19. 陈耀龙, 姚亮, 杜亮, 等. GRADE在系统评价中应用的必要性及注意事项.中国循证医学杂志, 2013, 13(12):1401-1404.
20. Lord SJ, Irwig L, Simes RJ. When is measuring sensitivity and specificity sufficient to evaluate a diagnostic test, and when do we need randomized trials? Ann Intern Med, 2006, 144(11):850-855.
21. 廖晓阳, 金成勇.如何在诊断性试验研究中正确应用有关测量指标.华西医学, 2000, 15(2):146-147.
22. 验证疗效网站.[2014-6-6]. Available at:http://cn.testingtreatments.org/.
23. 邬兰, 张永, 曾宪涛. QUADAS-2在诊断准确性研究的质量评价工具中的应用.湖北医药学院学报, 2013, 32(3):201-208.
24. Van der Windt DA, Simons E, Riphagen Ⅱ, Ammendolia C, et al. Physical examination for lumbar radiculopathy due to disc herniation in patients with low-back pain. Cochrane Database Syst Rev, 2010, (2):CD007431.
25. Fletcher R. Carcinoembryonic antigen. Ann Intern Med, 1986, 104(1):66-73.
26. Hlatky M, Pryor D, Harrell JR F, et al. Factors affecting sensitivity and specificity of exercise electrocardiography. Multivariable analysis. Am J Med, 1984, 77(1):64-71.
27. Levy D, Labib S, Anderson K, et al. Determinants of sensitivity and specificity of electrocardiographic criteria for left ventricular hypertrophy. Circulation, 1990, 81(3):815-820.
28. 田金徽, Fujian Song, 李伦, 等.间接比较方法简介.中国循证医学杂志, 2014, 14(3):365-368.
29. Guyatt GH, Oxman AD, Kunz R, 等. GRADE指南:Ⅶ.证据质量评价——不一致性.中国循证医学杂志, 2011, 11(12):1444-1451.
30. Buderer NM. Statistical methodology:I. Incorporating the prevalence ofdisease into the sample size calculation for sensitivity and specificity. Acad Emerg Med, 1996, 3(9):895-900.
31. Carley S, Dosman S, Jones SR. Simple nomograms to calculate sample size in diagnostic studies. Emerg Med J, 2005, 22(3):180-181.
32. Flahault A, Cadilhac M, Thomas G. Sample size calculation should be performed for design accuracy in diagnostic test studies. J Clin Epidemiol, 2005, 58(8):859-862.
33. Guyatt G, Oxman A, Montori V, et al. GRADE指南:Ⅴ.证据质量评价——发表偏倚.中国循证医学杂志, 2011, 11(12):1430-1434.
34. Begg CB, Berlin JA. Publication bias:A problem in interpreting medical data. Journal of the Royal Statistical Society, Series A, 1988, 151(3):419-463.
35. Begg CB, Mazumdar M. Operating characteristics of a rank correlation test for publication bias. Biometrics, 1994, 50(4):1088-1101.
36. Egger M, Smith GD, Schneider M, et al. Bias in meta-analysis detected by a simple, graphical test. BMJ, 1997, 315(7109):629-634.
37. Deeks JJ, Macaskill P, Irwig L:The performance of tests of publication bias and other sample size effects in systematic reviews of diagnostic test accuracy was assessed. J Clin Epidemiol, 2005, 58(9):882-893.
38. Macaskill P, Walter SD, Irwig L. A comparison of methods to detect publication bias in meta-analysis. Stat Med, 2001, 20(4):641-654.
39. Van Enst WA, Ochodo E, Scholten RJ, et al. Investigation of publication bias in meta-analyses of diagnostic test accuracy:a meta-epidemiological study. BMC Med Res Methodol, 2014, 14(1):70.
40. Terrin N, Schmid C H, Lau J. In an empirical evaluation of the funnel plot, researchers could not visually identify publication bias. Journal of clinical epidemiology, 2005, 58(9):894-901.
41. 杨书, 李婷婷, 刘新.应用漏斗图识别发表性偏倚的效率研究.成都医学院学报, 2007, 2(1):33-34.

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Rationales, Methods, Challenges and Development Tendency of Using GRADE in Systematic Reviews of Diagnostic Accuracy Tests

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