Study Design and Clinical Practice of Diagnostic Accucary Test

Li-fan ZHANG; Xiao-qing LIU

doi:10.3969/j.issn.1674-9081.20190276

Volume 11 Issue 1

Jan. 2020

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Medical Journal of Peking Union Medical College Hospital > 2020 > 11(1): 96-101. > DOI: 10.3969/j.issn.1674-9081.20190276

Li-fan ZHANG, Xiao-qing LIU. Study Design and Clinical Practice of Diagnostic Accucary Test[J]. Medical Journal of Peking Union Medical College Hospital, 2020, 11(1): 96-101. DOI: 10.3969/j.issn.1674-9081.20190276

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Study Design and Clinical Practice of Diagnostic Accucary Test

Li-fan ZHANG^{1, 2, 3},
Xiao-qing LIU^{1, 2, 3, ,}

1.
Department of Infectious Diseases, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing 100730, China
2.
Department of Clinical Epidemiology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing 100730, China
3.
Clinical Epideniology Unit, International Clinical Epidemiology Network, Beijing 100730, China

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Corresponding author:
LIU Xiao-qing Tel: 86-10-69155087, E-mail: liuxq@pumch.cn
Received Date: December 10, 2019
Issue Publish Date: January 29, 2020

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Abstract

Abstract

New diagnostic methods must be evaluated by rigorously designed diagnostic accuracy studies before clinical implementation. Designing a diagnostic accuracy study includes 8 procedures:constructing the research question with the PICOS (P:Patient; I:Intervention; C:Comparison; O:Outcome; S:Study design)framework, identifying an appropriate gold standard, choosing a representative patient sample, estimating the sample size, interpreting results of diagnostic tests and the gold standard blind to the other, setting up the optimal threshold, evaluating the diagnostic accuracy, and finally drafting a report according to the standards for reporting diagnostic accuracy. The accuracy of diagnostic tests includes sensitivity, specificity, predictive value (PV), and likelihood ratio (LR). The LR estimated by diagnostic tests can move clinicians from the pretest probability to a posttest probability. If the clinical setting is similar to that of the study and the patient meets all eligibility criteria of the study, the LR may facilitate the diagnostic process in clinical practice.
- diagnostic test,
- study design,
- clinical practice

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References

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