Statistical analysis of comparative diagnostic test accuracy study_Chinese Journal of Evidence-Based Medicine

Authors：

TIAN Chen ^1,2 , YANG Qiuyu ³ , LAI Honghao ^1,2 , LU Yao ^1,2 , TIAN Jinhui ^4,5 , LI Ni ⁶ , WANG Huilin ⁶ , ZHENG Yadi ⁶ , LI Jiang ⁶ ,  SHEN Xiping ⁷ ,  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;
7. Department of Epidemiology and Health Statistics, School of Public Health, Lanzhou University, Lanzhou 730000, P. R. China;

Corresponding author：

SHEN Xiping, Email: shenxp@lzu.edu.cn; GE Long, Email: gelong2009@163.com

Keywords：

Comparative diagnosis test accuracy; Sensitivity; Specificity; Statistical analysis

DOI：

10.7507/1672-2531.202205162

Video：

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The correct and reasonable statistical analysis method can make the results of comparative diagnosis test accuracy more convincing. In this paper, the accuracy of diagnostic tests is divided into 2 forms: binary-scale outcomes and ordinal-scale/continuous-scale outcomes. Taking diagnostic indicators such as sensitivity, specificity, receiver operating characteristic (ROC) curves and area under curve (AUC) values as entry points, combined with examples, this paper introduced how to compare the diagnostic results of tests by parameter estimation and hypothesis testing, with the aim of providing references for the comparative diagnosis test accuracy.

Citation： TIAN Chen, YANG Qiuyu, LAI Honghao, LU Yao, TIAN Jinhui, LI Ni, WANG Huilin, ZHENG Yadi, LI Jiang, SHEN Xiping, GE Long. Statistical analysis of comparative diagnostic test accuracy study. Chinese Journal of Evidence-Based Medicine, 2022, 22(12): 1474-1482. doi: 10.7507/1672-2531.202205162 Copy

1.	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.
2.	Cesana BM, Antonelli P, Chiumello D. Statistical methods for evidence-based medicine: the diagnostic test. Part I. Minerva Anestesiol, 2008, 74(7-8): 431-437.
3.	Antonelli P, Chiumello D, Cesana BM. Statistical methods for evidence-based medicine: the diagnostic test. Part II. Minerva Anestesiol, 2008, 74(9): 481-488.
4.	张丽帆, 刘晓清. 诊断试验准确性研究设计及临床应用. 协和医学杂志, 2020, 11(1): 96-101.
5.	陈平雁, 郭祖超, 胡琳. 比较两种诊断试验的统计方法. 中国卫生统计, 1990, 7(2): 22-25.
6.	Akobeng AK. Understanding diagnostic tests 2: likelihood ratios, pre- and post-test probabilities and their use in clinical practice. Acta Paediatr, 2007, 96(4): 487-491.
7.	袁世洋, 彭赖水, 谢军平, 等. ddPCR检测NSCLC患者血液EGFR基因突变准确性的Meta分析. 中国肿瘤, 2019, 28(6): 461-469.
8.	侯艳, 李康, 宇传华, 等. 诊断医学中的统计学方法(第2版). 北京: 高等教育出版社, 2016.
9.	曾宪套, 任学群. 应用STATA做Meta分析(第2版). 北京: 中国协和医科大学出版社, 2015.
10.	Yang B, Olsen M, Vali Y, et al. Study designs for comparative diagnostic test accuracy: a methodological review and classification scheme. J Clin Epidemiol, 2021, 138: 128-138.
11.	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.
12.	Hayen A, Macaskill P, Irwig L, et al. Appropriate statistical methods are required to assess diagnostic tests for replacement, add-on, and triage. J Clin Epidemiol, 2010, 63(8): 883-891.
13.	Biggerstaff BJ. Comparing diagnostic tests: a simple graphic using likelihood ratios. Stat Med, 2000, 19(5): 649-663.
14.	Glas AS, Lijmer JG, Prins MH, et al. The diagnostic odds ratio: a single indicator of test performance. J Clin Epidemiol, 2003, 56(11): 1129-1135.
15.	Hawass NE. Comparing the sensitivities and specificities of two diagnostic procedures performed on the same group of patients. Br J Radiol, 1997, 70(832): 360-366.
16.	陈平雁, 郭祖超, 胡琳. 比较配对诊断试验的统计方法. 中国卫生统计, 1989, 6(4): 19-23.
17.	Laméris W, van Randen A, van Es HW, et al. Imaging strategies for detection of urgent conditions in patients with acute abdominal pain: diagnostic accuracy study. BMJ, 2009, 338: b2431.
18.	李晓松, 陈峰, 郝元涛, 等. 卫生统计学(第8版). 北京: 人民卫生出版社, 2017.
19.	Knottnerus JA, Muris JW. Assessment of the accuracy of diagnostic tests: the cross-sectional study. J Clin Epidemiol, 2003, 56(11): 1118-1128.
20.	程勇谋, 莫耀良, 谭静, 等. 直肠超声引导下经直肠与经会阴穿刺活检诊断前列腺癌的临床价值及安全性比较. 海南医学, 2021, 32(17): 2227-2230.
21.	Houssami N, Irwig L, Simpson JM, et al. Sydney breast imaging accuracy study: comparative sensitivity and specificity of mammography and sonography in young women with symptoms. AJR Am J Roentgenol, 2003, 180(4): 935-940.
22.	王曼, 徐春燕, 施学忠. 医学论文中ROC曲线应用错误例析. 编辑学报, 2019, 31(2): 159-161.
23.	Mandrekar JN. Receiver operating characteristic curve in diagnostic test assessment. J Thorac Oncol, 2010, 5(9): 1315-1316.
24.	Obuchowski NA, Bullen JA. Receiver operating characteristic (ROC) curves: review of methods with applications in diagnostic medicine. Phys Med Biol, 2018, 63(7): 07TR01.
25.	Dendumrongsup T, Plumb AA, Halligan S, et al. Multi-reader multi-case studies using the area under the receiver operator characteristic curve as a measure of diagnostic accuracy: systematic review with a focus on quality of data reporting. PLoS One, 2014, 9(12): e116018.
26.	Galbraith S, Daniel JA, Vissel B. A study of clustered data and approaches to its analysis. J Neurosci, 2010, 30(32): 10601-10608.
27.	Genders TS, Spronk S, Stijnen T, et al. Methods for calculating sensitivity and specificity of clustered data: a tutorial. Radiology, 2012, 265(3): 910-916.
28.	Obuchowski NA. Nonparametric analysis of clustered ROC curve data. Biometrics, 1997, 53(2): 567-578.
29.	Hilton S, Herr HW, Teitcher JB, et al. CT detection of retroperitoneal lymph node metastases in patients with clinical stage I testicular nonseminomatous germ cell cancer: assessment of size and distribution criteria. AJR Am J Roentgenol, 1997, 169(2): 521-525.
30.	Venkatraman ES, Begg CB. A distribution-free procedure for comparing receiver operating characteristic curves from a paired experiment. Biometrika, 1996, 83(4): 835-848.

1. 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.
2. Cesana BM, Antonelli P, Chiumello D. Statistical methods for evidence-based medicine: the diagnostic test. Part I. Minerva Anestesiol, 2008, 74(7-8): 431-437.
3. Antonelli P, Chiumello D, Cesana BM. Statistical methods for evidence-based medicine: the diagnostic test. Part II. Minerva Anestesiol, 2008, 74(9): 481-488.
4. 张丽帆, 刘晓清. 诊断试验准确性研究设计及临床应用. 协和医学杂志, 2020, 11(1): 96-101.
5. 陈平雁, 郭祖超, 胡琳. 比较两种诊断试验的统计方法. 中国卫生统计, 1990, 7(2): 22-25.
6. Akobeng AK. Understanding diagnostic tests 2: likelihood ratios, pre- and post-test probabilities and their use in clinical practice. Acta Paediatr, 2007, 96(4): 487-491.
7. 袁世洋, 彭赖水, 谢军平, 等. ddPCR检测NSCLC患者血液EGFR基因突变准确性的Meta分析. 中国肿瘤, 2019, 28(6): 461-469.
8. 侯艳, 李康, 宇传华, 等. 诊断医学中的统计学方法(第2版). 北京: 高等教育出版社, 2016.
9. 曾宪套, 任学群. 应用STATA做Meta分析(第2版). 北京: 中国协和医科大学出版社, 2015.
10. Yang B, Olsen M, Vali Y, et al. Study designs for comparative diagnostic test accuracy: a methodological review and classification scheme. J Clin Epidemiol, 2021, 138: 128-138.
11. 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.
12. Hayen A, Macaskill P, Irwig L, et al. Appropriate statistical methods are required to assess diagnostic tests for replacement, add-on, and triage. J Clin Epidemiol, 2010, 63(8): 883-891.
13. Biggerstaff BJ. Comparing diagnostic tests: a simple graphic using likelihood ratios. Stat Med, 2000, 19(5): 649-663.
14. Glas AS, Lijmer JG, Prins MH, et al. The diagnostic odds ratio: a single indicator of test performance. J Clin Epidemiol, 2003, 56(11): 1129-1135.
15. Hawass NE. Comparing the sensitivities and specificities of two diagnostic procedures performed on the same group of patients. Br J Radiol, 1997, 70(832): 360-366.
16. 陈平雁, 郭祖超, 胡琳. 比较配对诊断试验的统计方法. 中国卫生统计, 1989, 6(4): 19-23.
17. Laméris W, van Randen A, van Es HW, et al. Imaging strategies for detection of urgent conditions in patients with acute abdominal pain: diagnostic accuracy study. BMJ, 2009, 338: b2431.
18. 李晓松, 陈峰, 郝元涛, 等. 卫生统计学(第8版). 北京: 人民卫生出版社, 2017.
19. Knottnerus JA, Muris JW. Assessment of the accuracy of diagnostic tests: the cross-sectional study. J Clin Epidemiol, 2003, 56(11): 1118-1128.
20. 程勇谋, 莫耀良, 谭静, 等. 直肠超声引导下经直肠与经会阴穿刺活检诊断前列腺癌的临床价值及安全性比较. 海南医学, 2021, 32(17): 2227-2230.
21. Houssami N, Irwig L, Simpson JM, et al. Sydney breast imaging accuracy study: comparative sensitivity and specificity of mammography and sonography in young women with symptoms. AJR Am J Roentgenol, 2003, 180(4): 935-940.
22. 王曼, 徐春燕, 施学忠. 医学论文中ROC曲线应用错误例析. 编辑学报, 2019, 31(2): 159-161.
23. Mandrekar JN. Receiver operating characteristic curve in diagnostic test assessment. J Thorac Oncol, 2010, 5(9): 1315-1316.
24. Obuchowski NA, Bullen JA. Receiver operating characteristic (ROC) curves: review of methods with applications in diagnostic medicine. Phys Med Biol, 2018, 63(7): 07TR01.
25. Dendumrongsup T, Plumb AA, Halligan S, et al. Multi-reader multi-case studies using the area under the receiver operator characteristic curve as a measure of diagnostic accuracy: systematic review with a focus on quality of data reporting. PLoS One, 2014, 9(12): e116018.
26. Galbraith S, Daniel JA, Vissel B. A study of clustered data and approaches to its analysis. J Neurosci, 2010, 30(32): 10601-10608.
27. Genders TS, Spronk S, Stijnen T, et al. Methods for calculating sensitivity and specificity of clustered data: a tutorial. Radiology, 2012, 265(3): 910-916.
28. Obuchowski NA. Nonparametric analysis of clustered ROC curve data. Biometrics, 1997, 53(2): 567-578.
29. Hilton S, Herr HW, Teitcher JB, et al. CT detection of retroperitoneal lymph node metastases in patients with clinical stage I testicular nonseminomatous germ cell cancer: assessment of size and distribution criteria. AJR Am J Roentgenol, 1997, 169(2): 521-525.
30. Venkatraman ES, Begg CB. A distribution-free procedure for comparing receiver operating characteristic curves from a paired experiment. Biometrika, 1996, 83(4): 835-848.

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