Advance in the GRADE approach to grade evidence from a systematic review of single diagnostic test accuracy_Chinese Journal of Evidence-Based Medicine

Authors：

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

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. Key Laboratory of Evidence Based Medicine and Knowledge Translation of Gansu Province, Lanzhou 730000, P. R. China;
5. Evidence Based Medicine Center, School of Basic Medical Sciences, Lanzhou University, 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：

GRADE approach; Quality of evidence; Certainty of evidence; Diagnostic test accuracy; Systematic review

DOI：

10.7507/1672-2531.202206021

Video：

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Previous methods of grading evidence for systematic reviews of diagnostic test accuracy have generally focused on assessing the certainty (quality) of evidence at the level of diagnostic indicators. When the question is not limited to follow the diagnostic test accuracy results themselves, the grading results may be inaccurate due to the lack of consideration of the downstream effects of the test accuracy in specific settings. To address these challenges, the GRADE working group conducted a series of studies focused on updating methods to explore or simulate important downstream effects of diagnostic test accuracy outcomes within a contextual framework. This paper aimed to introduce advances in the contextual framework of the GRADE approach to rate the certainty of evidence from systematic reviews of single diagnostic test accuracy.

Citation： LAI Honghao, YANG Qiuyu, SUN Mingyao, TIAN Chen, LU Yao, TIAN Jinhui, LI Jiang, GE Long. Advance in the GRADE approach to grade evidence from a systematic review of single diagnostic test accuracy. Chinese Journal of Evidence-Based Medicine, 2022, 22(9): 1090-1098. doi: 10.7507/1672-2531.202206021 Copy

1.	Hsu J, Brożek JL, Terracciano L, et al. Application of GRADE: making evidence-based recommendations about diagnostic tests in clinical practice guidelines. Implement Sci, 2011, 6: 62.
2.	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.
3.	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.
4.	陆瑶, 杨秋玉, 赖鸿皓, 等. 诊断试验准确性比较研究: 系统评价证据分级. 中国循证医学杂志, 2022, DOI: 10.7507/1672-2531.202206039.
5.	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.
6.	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.
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.	王云云, 邓通, 黄桥, 等. 临床实践指南制订方法—GRADE在诊断试验系统评价中的应用. 中国循证心血管医学杂志, 2019, 11(3): 275-279.
9.	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.
10.	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.
11.	Brignardello-Petersen R, Florez ID, Izcovich A, et al. GRADE approach to drawing conclusions from a network meta-analysis using a minimally contextualised framework. BMJ, 2020, 371: m3900.
12.	Brignardello-Petersen R, Izcovich A, Rochwerg B, et al. GRADE approach to drawing conclusions from a network meta-analysis using a partially contextualised framework. BMJ, 2020, 371: m3907.
13.	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.
14.	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.
15.	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.
16.	Nadarevic T, Colli A, Giljaca V, et al. Magnetic resonance imaging for the diagnosis of hepatocellular carcinoma in adults with chronic liver disease. Cochrane Database Syst Rev, 2022, (5): CD014798.
17.	Brozek JL, Akl EA, Alonso-Coello P, et al. Grading quality of evidence and strength of recommendations in clinical practice guidelines. Part 1 of 3. An overview of the GRADE approach and grading quality of evidence about interventions. Allergy, 2009, 64(5): 669-677.
18.	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.
19.	Brożek JL, Akl EA, Compalati E, et al. Grading quality of evidence and strength of recommendations in clinical practice guidelines part 3 of 3. The GRADE approach to developing recommendations. Allergy, 2011, 66(5): 588-595.
20.	Guyatt GH, Ebrahim S, Alonso-Coello P, et al. GRADE guidelines 17: assessing the risk of bias associated with missing participant outcome data in a body of evidence. J Clin Epidemiol, 2017, 87: 14-22.
21.	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.
22.	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.
23.	Zhang Y, Alonso-Coello P, Guyatt GH, et al. GRADE Guidelines: 19. Assessing the certainty of evidence in the importance of outcomes or values and preferences-Risk of bias and indirectness. J Clin Epidemiol, 2019, 111: 94-104.
24.	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.
25.	Guyatt GH, Oxman AD, Kunz R, et al. GRADE guidelines: 7. Rating the quality of evidence-inconsistency. J Clin Epidemiol, 2011, 64(12): 1294-1302.
26.	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.
27.	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.
28.	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.
29.	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.
30.	Chidambaranathan-Reghupaty S, Fisher PB, Sarkar D. Hepatocellular carcinoma (HCC): epidemiology, etiology and molecular classification. Adv Cancer Res, 2021, 149: 1-61.
31.	European Association for the Study of the Liver. EASL clinical practice guidelines: management of hepatocellular carcinoma. J Hepatol, 2018, 69(1): 182-236.
32.	Neuberger J, Patel J, Caldwell H, et al. Guidelines on the use of liver biopsy in clinical practice from the British Society of Gastroenterology, the Royal College of Radiologists and the Royal College of Pathology. Gut, 2020, 69(8): 1382-1403.
33.	Mulazzani L, Terzi E, Casadei G, et al. Retrospective analysis of safety of ultrasound-guided percutaneous liver biopsy in the 21st century. Eur J Gastroenterol Hepatol, 2021, 33(Suppl 1): e355-e362.
34.	Guyatt GH, Oxman AD, Montori V, et al. GRADE guidelines: 5. Rating the quality of evidence-publication bias. J Clin Epidemiol, 2011, 64(12): 1277-1282.
35.	Begg CB, Mazumdar M. Operating characteristics of a rank correlation test for publication bias. Biometrics, 1994, 50(4): 1088-1101.
36.	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.
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.	Bürkner PC, Doebler P. Testing for publication bias in diagnostic meta-analysis: a simulation study. Stat Med, 2014, 33(18): 3061-3077.
39.	Kohli M, Schiller I, Dendukuri N, et al. Xpert ® MTB/RIF assay for extrapulmonary tuberculosis and rifampicin resistance. Cochrane Database Syst Rev, 2018, (8): CD012768.
40.	Alonso-Coello P, Schünemann HJ, Moberg J, et al. GRADE Evidence to Decision (EtD) frameworks: a systematic and transparent approach to making well informed healthcare choices. 1:Introduction. BMJ, 2016, 353: i2016.
41.	Guyatt GH, Oxman AD, Sultan S, et al. GRADE guidelines: 9. Rating up the quality of evidence. J Clin Epidemiol, 2011, 64(12): 1311-1316.
42.	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.

1. Hsu J, Brożek JL, Terracciano L, et al. Application of GRADE: making evidence-based recommendations about diagnostic tests in clinical practice guidelines. Implement Sci, 2011, 6: 62.
2. 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.
3. 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.
4. 陆瑶, 杨秋玉, 赖鸿皓, 等. 诊断试验准确性比较研究: 系统评价证据分级. 中国循证医学杂志, 2022, DOI: 10.7507/1672-2531.202206039.
5. 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.
6. 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.
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. 王云云, 邓通, 黄桥, 等. 临床实践指南制订方法—GRADE在诊断试验系统评价中的应用. 中国循证心血管医学杂志, 2019, 11(3): 275-279.
9. 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.
10. 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.
11. Brignardello-Petersen R, Florez ID, Izcovich A, et al. GRADE approach to drawing conclusions from a network meta-analysis using a minimally contextualised framework. BMJ, 2020, 371: m3900.
12. Brignardello-Petersen R, Izcovich A, Rochwerg B, et al. GRADE approach to drawing conclusions from a network meta-analysis using a partially contextualised framework. BMJ, 2020, 371: m3907.
13. 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.
14. 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.
15. 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.
16. Nadarevic T, Colli A, Giljaca V, et al. Magnetic resonance imaging for the diagnosis of hepatocellular carcinoma in adults with chronic liver disease. Cochrane Database Syst Rev, 2022, (5): CD014798.
17. Brozek JL, Akl EA, Alonso-Coello P, et al. Grading quality of evidence and strength of recommendations in clinical practice guidelines. Part 1 of 3. An overview of the GRADE approach and grading quality of evidence about interventions. Allergy, 2009, 64(5): 669-677.
18. 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.
19. Brożek JL, Akl EA, Compalati E, et al. Grading quality of evidence and strength of recommendations in clinical practice guidelines part 3 of 3. The GRADE approach to developing recommendations. Allergy, 2011, 66(5): 588-595.
20. Guyatt GH, Ebrahim S, Alonso-Coello P, et al. GRADE guidelines 17: assessing the risk of bias associated with missing participant outcome data in a body of evidence. J Clin Epidemiol, 2017, 87: 14-22.
21. 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.
22. 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.
23. Zhang Y, Alonso-Coello P, Guyatt GH, et al. GRADE Guidelines: 19. Assessing the certainty of evidence in the importance of outcomes or values and preferences-Risk of bias and indirectness. J Clin Epidemiol, 2019, 111: 94-104.
24. 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.
25. Guyatt GH, Oxman AD, Kunz R, et al. GRADE guidelines: 7. Rating the quality of evidence-inconsistency. J Clin Epidemiol, 2011, 64(12): 1294-1302.
26. 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.
27. 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.
28. 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.
29. 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.
30. Chidambaranathan-Reghupaty S, Fisher PB, Sarkar D. Hepatocellular carcinoma (HCC): epidemiology, etiology and molecular classification. Adv Cancer Res, 2021, 149: 1-61.
31. European Association for the Study of the Liver. EASL clinical practice guidelines: management of hepatocellular carcinoma. J Hepatol, 2018, 69(1): 182-236.
32. Neuberger J, Patel J, Caldwell H, et al. Guidelines on the use of liver biopsy in clinical practice from the British Society of Gastroenterology, the Royal College of Radiologists and the Royal College of Pathology. Gut, 2020, 69(8): 1382-1403.
33. Mulazzani L, Terzi E, Casadei G, et al. Retrospective analysis of safety of ultrasound-guided percutaneous liver biopsy in the 21st century. Eur J Gastroenterol Hepatol, 2021, 33(Suppl 1): e355-e362.
34. Guyatt GH, Oxman AD, Montori V, et al. GRADE guidelines: 5. Rating the quality of evidence-publication bias. J Clin Epidemiol, 2011, 64(12): 1277-1282.
35. Begg CB, Mazumdar M. Operating characteristics of a rank correlation test for publication bias. Biometrics, 1994, 50(4): 1088-1101.
36. 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.
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. Bürkner PC, Doebler P. Testing for publication bias in diagnostic meta-analysis: a simulation study. Stat Med, 2014, 33(18): 3061-3077.
39. Kohli M, Schiller I, Dendukuri N, et al. Xpert ® MTB/RIF assay for extrapulmonary tuberculosis and rifampicin resistance. Cochrane Database Syst Rev, 2018, (8): CD012768.
40. Alonso-Coello P, Schünemann HJ, Moberg J, et al. GRADE Evidence to Decision (EtD) frameworks: a systematic and transparent approach to making well informed healthcare choices. 1:Introduction. BMJ, 2016, 353: i2016.
41. Guyatt GH, Oxman AD, Sultan S, et al. GRADE guidelines: 9. Rating up the quality of evidence. J Clin Epidemiol, 2011, 64(12): 1311-1316.
42. 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.

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