GRADE approach in systematic reviews of comparative diagnostic accuracy study_Chinese Journal of Evidence-Based Medicine

Authors：

LU Yao ^1,2 , YANG Qiuyu ³ , LAI Honghao ^1,2 , TIAN Chen ^1,2 , CHEN Yaolong ^4,5 , TIAN Jinhui ^4,5 , LI Ni ⁶ ,  LI Jiang ⁶ ,  GE Long ^1,2,5

1. Evidence-Based Social Science Research Center, School of Public Health, Lanzhou University, Lanzhou 730000, P. R. China;
2. Department of Social Science and Health Management, School of Public Health, Lanzhou University, Lanzhou 730000, P. R. China;
3. Evidence Based Nursing Centre, School of Nursing, Lanzhou University, Lanzhou 730000, P. R. China;
4. Evidence-based Medicine Center, School of Basic Medical Sciences, Lanzhou University, Lanzhou 730000, P. R. China;
5. Key Laboratory of Evidence Based Medicine and Knowledge Translation of Gansu Province, Lanzhou 730000, P. R. China;
6. National Cancer Center/National Cancer Clinical Medical Research Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, P. R. China;

Corresponding author：

LI Jiang, Email: lij@cicams.ac.cn; GE Long, Email: gelong2009@163.com

Keywords：

Comparative diagnostic test accuracy study; GRADE; Grading evidence; Systematic review

DOI：

10.7507/1672-2531.202206039

Video：

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Comparative diagnostic test accuracy study, a type of diagnostic accuracy test, aims to compare accuracy of two or more index tests in a study. The application of GRADE in comparative test accuracy differs from single test accuracy, mainly including the selection of appropriate comparative study designs, additional criteria for judging risk of bias, and the consequences of using comparative measures of test accuracy. The study focuses on basic principles and methods of GRADE approach in systematic reviews of comparative test accuracy to promote the understanding and application of the method by domestic scholars.

Citation： LU Yao, YANG Qiuyu, LAI Honghao, TIAN Chen, CHEN Yaolong, TIAN Jinhui, LI Ni, LI Jiang, GE Long. GRADE approach in systematic reviews of comparative diagnostic accuracy study. Chinese Journal of Evidence-Based Medicine, 2022, 22(10): 1233-1240. doi: 10.7507/1672-2531.202206039 Copy

1.	Takwoingi Y, Leeflang MM, Deeks JJ. Empirical evidence of the importance of comparative studies of diagnostic test accuracy. Ann Intern Med, 2013, 158(7): 544-554.
2.	Yang B, Vali Y, Dehmoobad Sharifabadi A, et al. Risk of bias assessment of test comparisons was uncommon in comparative accuracy systematic reviews: an overview of reviews. J Clin Epidemiol, 2020, 127: 167-174.
3.	Dehmoobad Sharifabadi A, Leeflang M, Treanor L, et al. Comparative reviews of diagnostic test accuracy in imaging research: evaluation of current practices. Eur Radiol, 2019, 29(10): 5386-5394.
4.	Yang B, Mallett S, Takwoingi Y, et al. QUADAS-C: a tool for assessing risk of bias in comparative diagnostic accuracy studies. Ann Intern Med, 2021, 174(11): 1592-1599.
5.	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): 529-536.
6.	Takwoingi Y. Meta-analytic approaches for summarising and comparing the accuracy of medical tests. Birmingham: University of Birmingham Research Archive, 2016.
7.	Leeflang MM. Systematic reviews and meta-analyses of diagnostic test accuracy. Clin Microbiol Infect, 2014, 20(2): 105-113.
8.	陈耀龙, 姚亮, Norris S, 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.
9.	Guyatt G, Oxman AD, Akl EA, et al. GRADE guidelines: 1. Introduction-GRADE evidence profiles and summary of findings tables. J Clin Epidemiol, 2011, 64(4): 383-394.
10.	张薇, 许吉, 邓宏勇. 国际医学证据分级与推荐体系发展及现状. 中国循证医学杂志, 2019, 19(11): 1373-1378.
11.	Leeflang MM, Deeks JJ, Takwoingi Y, et al. Cochrane diagnostic test accuracy reviews. Syst Rev, 2013, 2: 82.
12.	Yang B, Mustafa RA, Bossuyt PM, et al. GRADE Guidance: 31. Assessing the certainty across a body of evidence for comparative test accuracy. J Clin Epidemiol, 2021, 136: 146-156.
13.	田晨, 杨秋玉, 赖鸿皓, 等. 诊断性试验准确性比较研究. 中国循证医学杂志, 2022, 22(5): 590-594.
14.	杨秋玉, 陆瑶, 田晨, 等. 诊断试验准确性比较研究: 研究设计. 中国循证医学杂志, 2022, 22(6): 739-744.
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.	Schünemann HJ, Mustafa RA, Brozek J, et al. GRADE guidelines: 21 part 1. Study design, risk of bias, and indirectness in rating the certainty across a body of evidence for test accuracy. J Clin Epidemiol, 2020, 122: 129-141.
17.	Schünemann HJ, Mustafa RA, Brozek J, et al. GRADE guidelines: 21 part 2. Test accuracy: inconsistency, imprecision, publication bias, and other domains for rating the certainty of evidence and presenting it in evidence profiles and summary of findings tables. J Clin Epidemiol, 2020, 122: 142-152.
18.	Schünemann HJ, Mustafa RA, Brozek J, et al. GRADE guidelines: 22. The GRADE approach for tests and strategies-from test accuracy to patient-important outcomes and recommendations. J Clin Epidemiol, 2019, 111: 69-82.
19.	Hultcrantz M, Mustafa RA, Leeflang MMG, et al. Defining ranges for certainty ratings of diagnostic accuracy: a GRADE concept paper. J Clin Epidemiol, 2020, 117: 138-148.
20.	Tikkinen KAO, Craigie S, Schünemann HJ, et al. Certainty ranges facilitated explicit and transparent judgments regarding evidence credibility. J Clin Epidemiol, 2018, 104: 46-51.
21.	Buderer NM. Statistical methodology: I. Incorporating the prevalence of disease into the sample size calculation for sensitivity and specificity. Acad Emerg Med, 1996, 3(9): 895-900.
22.	Carley S, Dosman S, Jones SR, et al. Simple nomograms to calculate sample size in diagnostic studies. Emerg Med J, 2005, 22(3): 180-181.
23.	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.
24.	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.
25.	Schünemann HJ, Oxman AD, Brozek J, et al. Grading quality of evidence and strength of recommendations for diagnostic tests and strategies. BMJ, 2008, 336(7653): 1106-1110.
26.	Schünemann HJ, Mustafa R, Brozek J, et al. GRADE Guidelines: 16. GRADE evidence to decision frameworks for tests in clinical practice and public health. J Clin Epidemiol, 2016, 76: 89-98.
27.	Hultcrantz M, Rind D, Akl EA, et al. The GRADE Working Group clarifies the construct of certainty of evidence. J Clin Epidemiol, 2017, 87: 4-13.
28.	栗梦婷, 朱鸿飞, 后亮瑛, 等. 网状Meta分析结论形成的方法: 最小背景化框架. 中国循证医学杂志, 2021, 21(9): 1102-1109.
29.	朱鸿飞, 栗梦婷, 后亮瑛, 等. 网状Meta分析结论形成的方法: 部分背景化框架. 中国循证医学杂志, 2021, 21(9): 1110-1116.
30.	Mustafa RA, Santesso N, Khatib R, et al. Systematic reviews and meta-analyses of the accuracy of HPV tests, visual inspection with acetic acid, cytology, and colposcopy. Int J Gynaecol Obstet, 2016, 132(3): 259-265.
31.	Guyatt GH, Oxman AD, Kunz R, et al. GRADE guidelines 6. Rating the quality of evidence-imprecision. J Clin Epidemiol, 2011, 64(12): 1283-1293.
32.	Guyatt G, Oxman DA, Kunz R, 等. GRADE指南: Ⅵ. 证据质量评价—不精确性(随机误差). 中国循证医学杂志, 2011, 11(12): 1435-1443.
33.	Egger M, Davey Smith G, Schneider M, et al. Bias in meta-analysis detected by a simple, graphical test. BMJ, 1997, 315(7109): 629-634.
34.	Begg CB, Mazumdar M. Operating characteristics of a rank correlation test for publication bias. Biometrics, 1994, 50(4): 1088-1101.
35.	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.
36.	Duval S, Tweedie R. Trim and fill: A simple funnel-plot-based method of testing and adjusting for publication bias in meta-analysis. Biometrics, 2000, 56(2): 455-463.
37.	Bürkner PC, Doebler P. Testing for publication bias in diagnostic meta-analysis: a simulation study. Stat Med, 2014, 33(18): 3061-3077.

1. Takwoingi Y, Leeflang MM, Deeks JJ. Empirical evidence of the importance of comparative studies of diagnostic test accuracy. Ann Intern Med, 2013, 158(7): 544-554.
2. Yang B, Vali Y, Dehmoobad Sharifabadi A, et al. Risk of bias assessment of test comparisons was uncommon in comparative accuracy systematic reviews: an overview of reviews. J Clin Epidemiol, 2020, 127: 167-174.
3. Dehmoobad Sharifabadi A, Leeflang M, Treanor L, et al. Comparative reviews of diagnostic test accuracy in imaging research: evaluation of current practices. Eur Radiol, 2019, 29(10): 5386-5394.
4. Yang B, Mallett S, Takwoingi Y, et al. QUADAS-C: a tool for assessing risk of bias in comparative diagnostic accuracy studies. Ann Intern Med, 2021, 174(11): 1592-1599.
5. 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): 529-536.
6. Takwoingi Y. Meta-analytic approaches for summarising and comparing the accuracy of medical tests. Birmingham: University of Birmingham Research Archive, 2016.
7. Leeflang MM. Systematic reviews and meta-analyses of diagnostic test accuracy. Clin Microbiol Infect, 2014, 20(2): 105-113.
8. 陈耀龙, 姚亮, Norris S, 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.
9. Guyatt G, Oxman AD, Akl EA, et al. GRADE guidelines: 1. Introduction-GRADE evidence profiles and summary of findings tables. J Clin Epidemiol, 2011, 64(4): 383-394.
10. 张薇, 许吉, 邓宏勇. 国际医学证据分级与推荐体系发展及现状. 中国循证医学杂志, 2019, 19(11): 1373-1378.
11. Leeflang MM, Deeks JJ, Takwoingi Y, et al. Cochrane diagnostic test accuracy reviews. Syst Rev, 2013, 2: 82.
12. Yang B, Mustafa RA, Bossuyt PM, et al. GRADE Guidance: 31. Assessing the certainty across a body of evidence for comparative test accuracy. J Clin Epidemiol, 2021, 136: 146-156.
13. 田晨, 杨秋玉, 赖鸿皓, 等. 诊断性试验准确性比较研究. 中国循证医学杂志, 2022, 22(5): 590-594.
14. 杨秋玉, 陆瑶, 田晨, 等. 诊断试验准确性比较研究: 研究设计. 中国循证医学杂志, 2022, 22(6): 739-744.
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. Schünemann HJ, Mustafa RA, Brozek J, et al. GRADE guidelines: 21 part 1. Study design, risk of bias, and indirectness in rating the certainty across a body of evidence for test accuracy. J Clin Epidemiol, 2020, 122: 129-141.
17. Schünemann HJ, Mustafa RA, Brozek J, et al. GRADE guidelines: 21 part 2. Test accuracy: inconsistency, imprecision, publication bias, and other domains for rating the certainty of evidence and presenting it in evidence profiles and summary of findings tables. J Clin Epidemiol, 2020, 122: 142-152.
18. Schünemann HJ, Mustafa RA, Brozek J, et al. GRADE guidelines: 22. The GRADE approach for tests and strategies-from test accuracy to patient-important outcomes and recommendations. J Clin Epidemiol, 2019, 111: 69-82.
19. Hultcrantz M, Mustafa RA, Leeflang MMG, et al. Defining ranges for certainty ratings of diagnostic accuracy: a GRADE concept paper. J Clin Epidemiol, 2020, 117: 138-148.
20. Tikkinen KAO, Craigie S, Schünemann HJ, et al. Certainty ranges facilitated explicit and transparent judgments regarding evidence credibility. J Clin Epidemiol, 2018, 104: 46-51.
21. Buderer NM. Statistical methodology: I. Incorporating the prevalence of disease into the sample size calculation for sensitivity and specificity. Acad Emerg Med, 1996, 3(9): 895-900.
22. Carley S, Dosman S, Jones SR, et al. Simple nomograms to calculate sample size in diagnostic studies. Emerg Med J, 2005, 22(3): 180-181.
23. 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.
24. 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.
25. Schünemann HJ, Oxman AD, Brozek J, et al. Grading quality of evidence and strength of recommendations for diagnostic tests and strategies. BMJ, 2008, 336(7653): 1106-1110.
26. Schünemann HJ, Mustafa R, Brozek J, et al. GRADE Guidelines: 16. GRADE evidence to decision frameworks for tests in clinical practice and public health. J Clin Epidemiol, 2016, 76: 89-98.
27. Hultcrantz M, Rind D, Akl EA, et al. The GRADE Working Group clarifies the construct of certainty of evidence. J Clin Epidemiol, 2017, 87: 4-13.
28. 栗梦婷, 朱鸿飞, 后亮瑛, 等. 网状Meta分析结论形成的方法: 最小背景化框架. 中国循证医学杂志, 2021, 21(9): 1102-1109.
29. 朱鸿飞, 栗梦婷, 后亮瑛, 等. 网状Meta分析结论形成的方法: 部分背景化框架. 中国循证医学杂志, 2021, 21(9): 1110-1116.
30. Mustafa RA, Santesso N, Khatib R, et al. Systematic reviews and meta-analyses of the accuracy of HPV tests, visual inspection with acetic acid, cytology, and colposcopy. Int J Gynaecol Obstet, 2016, 132(3): 259-265.
31. Guyatt GH, Oxman AD, Kunz R, et al. GRADE guidelines 6. Rating the quality of evidence-imprecision. J Clin Epidemiol, 2011, 64(12): 1283-1293.
32. Guyatt G, Oxman DA, Kunz R, 等. GRADE指南: Ⅵ. 证据质量评价—不精确性(随机误差). 中国循证医学杂志, 2011, 11(12): 1435-1443.
33. Egger M, Davey Smith G, Schneider M, et al. Bias in meta-analysis detected by a simple, graphical test. BMJ, 1997, 315(7109): 629-634.
34. Begg CB, Mazumdar M. Operating characteristics of a rank correlation test for publication bias. Biometrics, 1994, 50(4): 1088-1101.
35. 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.
36. Duval S, Tweedie R. Trim and fill: A simple funnel-plot-based method of testing and adjusting for publication bias in meta-analysis. Biometrics, 2000, 56(2): 455-463.
37. Bürkner PC, Doebler P. Testing for publication bias in diagnostic meta-analysis: a simulation study. Stat Med, 2014, 33(18): 3061-3077.

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