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

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