Comparative diagnostic accuracy study: study design_Chinese Journal of Evidence-Based Medicine

Authors：

YANG Qiuyu ¹ , LU Yao ^2,3 ^# , TIAN Chen ^2,3 , LAI Honghao ^2,3 , XIE Xinling ⁴ , TIAN Jinhui ^5,6 , LI Ni ⁷ ,  LI Jiang ⁷ ,  GE Long ^2,3,6

1. Evidence Based Nursing Centre, School of Nursing, Lanzhou University, Lanzhou 730000, P. R. China;
2. Evidence-Based Social Science Research Center, School of Public Health, Lanzhou University, Lanzhou 730000, P. R. China;
3. Department of Social Science and Health Management, School of Public Health, Lanzhou University, Lanzhou 730000, P. R. China;
4. The Second School of Clinical Medicine of Lanzhou University, Lanzhou 730000, P. R. China;
5. Evidence Based Medicine Center, School of Basic Medical Sciences, Lanzhou University, Lanzhou 730000, P. R. China;
6. Key Laboratory of Evidence Based Medicine and Knowledge Translation of Gansu Province, Lanzhou 730000, P. R. China;
7. 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：

Diagnostic test; Comparative diagnostic test accuracy study; Study design

DOI：

10.7507/1672-2531.202203022

Video：

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Scientific and rigorous study design could improve the reliability of results of the comparative diagnostic test accuracy studies. The design procedures of a comparative diagnostic test accuracy study included: constructing the clinical questions, identifying the appropriate gold standard, selecting the representative patient sample, calculating the sample size, blindly interpreting and comparing the results of diagnostic tests, and setting up the cut-off value. This paper introduced 5 categories of the designs of comparative diagnostic test accuracy studies: fully paired, partially paired with a random subset, partially paired with a nonrandom subset, unpaired randomized, and unpaired nonrandomized design.

Citation： YANG Qiuyu, LU Yao, TIAN Chen, LAI Honghao, XIE Xinling, TIAN Jinhui, LI Ni, LI Jiang, GE Long. Comparative diagnostic accuracy study: study design. Chinese Journal of Evidence-Based Medicine, 2022, 22(6): 739-744. doi: 10.7507/1672-2531.202203022 Copy

1.	高亚, 孙凤, 武珊珊, 等. 网络Meta分析研究进展系列(五): 诊断试验准确性网络Meta分析. 中国循证心血管医学杂志, 2020, 12(10): 1161-1165.
2.	陈耀龙, 姚亮, 杜亮, 等. GRADE在诊断准确性试验系统评价中应用的原理、方法、挑战及发展趋势. 中国循证医学杂志, 2014, 14(11): 1402-1406.
3.	Bossuyt PM, Irwig L, Craig J, et al. Comparative accuracy: assessing new tests against existing diagnostic pathways. BMJ, 2006, 332(7549): 1089-1092.
4.	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.
5.	Dehmoobad SA, 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.
6.	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.
7.	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.
8.	Thiese MS. Observational and interventional study design types: an overview. Biochem Med (Zagreb), 2014, 24(2): 199-210.
9.	Takwoingi Y, Partlett C, Riley RD, et al. Methods and reporting of systematic reviews of comparative accuracy were deficient: a methodological survey and proposed guidance. J Clin Epidemiol, 2020, 121: 1-14.
10.	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.
11.	Luijendijk HJ. How to create PICO questions about diagnostic tests. BMJ Evid Based Med, 2021, 26(4): 155-157.
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.	李强. 如何正确开展临床诊断性研究—诊断试验研究设计的基本原则. 中国全科医学, 2006, (2): 170-171.
14.	刘芬. 诊断试验研究在医学科研中的理论, 设计和实践. 北京医学, 2020, 42(11): 1151-1155.
15.	田金徽, 陈杰峰. 诊断试验系统评价/Meta分析. 北京: 中国医药科技出版社, 2015: 3.
16.	Glasziou P, Irwig L, Deeks JJ. When should a new test become the current reference standard. Ann Intern Med, 2008, 149(11): 816-822.
17.	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.
18.	Hajian-Tilaki K. Sample size estimation in diagnostic test studies of biomedical informatics. J Biomed Inform, 2014, 48: 193-204.
19.	Agorastos T, Chatzistamatiou K, Katsamagkas T, et al. Primary screening for cervical cancer based on high-risk human papillomavirus (HPV) detection and HPV 16 and HPV 18 genotyping, in comparison to cytology. PLoS One, 2015, 10(3): e0119755.
20.	Schaefgen B, Mati M, Sinn HP, et al. Can routine imaging after neoadjuvant chemotherapy in breast cancer predict pathologic complete response. Ann Surg Oncol, 2016, 23(3): 789-795.
21.	Carrara S, Anderloni A, Jovani M, et al. A prospective randomized study comparing 25-G and 22-G needles of a new platform for endoscopic ultrasound-guided fine needle aspiration of solid masses. Dig Liver Dis, 2016, 48(1): 49-54.
22.	Sheridan K, Kreulen C, Kim S, et al. Accuracy of magnetic resonance imaging to diagnose superior labrum anterior-posterior tears. Knee Surg Sports Traumatol Arthrosc, 2015, 23(9): 2645-2650.

1. 高亚, 孙凤, 武珊珊, 等. 网络Meta分析研究进展系列(五): 诊断试验准确性网络Meta分析. 中国循证心血管医学杂志, 2020, 12(10): 1161-1165.
2. 陈耀龙, 姚亮, 杜亮, 等. GRADE在诊断准确性试验系统评价中应用的原理、方法、挑战及发展趋势. 中国循证医学杂志, 2014, 14(11): 1402-1406.
3. Bossuyt PM, Irwig L, Craig J, et al. Comparative accuracy: assessing new tests against existing diagnostic pathways. BMJ, 2006, 332(7549): 1089-1092.
4. 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.
5. Dehmoobad SA, 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.
6. 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.
7. 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.
8. Thiese MS. Observational and interventional study design types: an overview. Biochem Med (Zagreb), 2014, 24(2): 199-210.
9. Takwoingi Y, Partlett C, Riley RD, et al. Methods and reporting of systematic reviews of comparative accuracy were deficient: a methodological survey and proposed guidance. J Clin Epidemiol, 2020, 121: 1-14.
10. 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.
11. Luijendijk HJ. How to create PICO questions about diagnostic tests. BMJ Evid Based Med, 2021, 26(4): 155-157.
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. 李强. 如何正确开展临床诊断性研究—诊断试验研究设计的基本原则. 中国全科医学, 2006, (2): 170-171.
14. 刘芬. 诊断试验研究在医学科研中的理论, 设计和实践. 北京医学, 2020, 42(11): 1151-1155.
15. 田金徽, 陈杰峰. 诊断试验系统评价/Meta分析. 北京: 中国医药科技出版社, 2015: 3.
16. Glasziou P, Irwig L, Deeks JJ. When should a new test become the current reference standard. Ann Intern Med, 2008, 149(11): 816-822.
17. 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.
18. Hajian-Tilaki K. Sample size estimation in diagnostic test studies of biomedical informatics. J Biomed Inform, 2014, 48: 193-204.
19. Agorastos T, Chatzistamatiou K, Katsamagkas T, et al. Primary screening for cervical cancer based on high-risk human papillomavirus (HPV) detection and HPV 16 and HPV 18 genotyping, in comparison to cytology. PLoS One, 2015, 10(3): e0119755.
20. Schaefgen B, Mati M, Sinn HP, et al. Can routine imaging after neoadjuvant chemotherapy in breast cancer predict pathologic complete response. Ann Surg Oncol, 2016, 23(3): 789-795.
21. Carrara S, Anderloni A, Jovani M, et al. A prospective randomized study comparing 25-G and 22-G needles of a new platform for endoscopic ultrasound-guided fine needle aspiration of solid masses. Dig Liver Dis, 2016, 48(1): 49-54.
22. Sheridan K, Kreulen C, Kim S, et al. Accuracy of magnetic resonance imaging to diagnose superior labrum anterior-posterior tears. Knee Surg Sports Traumatol Arthrosc, 2015, 23(9): 2645-2650.

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