Diagnostic test evaluation methodology: A systematic review of methods employed to evaluate diagnostic tests in the absence of gold standard – An update

Autoři: Chinyereugo M. Umemneku Chikere aff001;  Kevin Wilson aff002;  Sara Graziadio aff003;  Luke Vale aff001;  A. Joy Allen aff004
Působiště autorů: Institute of Health & Society, Faculty of Medical Sciences Newcastle University, Newcastle upon Tyne, England, United Kingdom aff001;  School of Mathematics, Statistics and Physics, Newcastle University, Newcastle upon Tyne, England, United Kingdom aff002;  National Institute for Health Research, Newcastle In Vitro Diagnostics Co-operative, Newcastle upon Tyne Hospitals National Health Services Foundation Trust, Newcastle upon Tyne, England, United Kingdom aff003;  National Institute for Health Research, Newcastle In Vitro Diagnostics Co-operative, Newcastle University, Newcastle upon Tyne, England, United Kingdom aff004
Vyšlo v časopise: PLoS ONE 14(10)
Kategorie: Research Article
doi: 10.1371/journal.pone.0223832



To systematically review methods developed and employed to evaluate the diagnostic accuracy of medical test when there is a missing or no gold standard.

Study design and settings

Articles that proposed or applied any methods to evaluate the diagnostic accuracy of medical test(s) in the absence of gold standard were reviewed. The protocol for this review was registered in PROSPERO (CRD42018089349).


Identified methods were classified into four main groups: methods employed when there is a missing gold standard; correction methods (which make adjustment for an imperfect reference standard with known diagnostic accuracy measures); methods employed to evaluate a medical test using multiple imperfect reference standards; and other methods, like agreement studies, and a mixed group of alternative study designs. Fifty-one statistical methods were identified from the review that were developed to evaluate medical test(s) when the true disease status of some participants is unverified with the gold standard. Seven correction methods were identified and four methods were identified to evaluate medical test(s) using multiple imperfect reference standards. Flow-diagrams were developed to guide the selection of appropriate methods.


Various methods have been proposed to evaluate medical test(s) in the absence of a gold standard for some or all participants in a diagnostic accuracy study. These methods depend on the availability of the gold standard, its’ application to the participants in the study and the availability of alternative reference standard(s). The clinical application of some of these methods, especially methods developed when there is missing gold standard is however limited. This may be due to the complexity of these methods and/or a disconnection between the fields of expertise of those who develop (e.g. mathematicians) and those who employ the methods (e.g. clinical researchers). This review aims to help close this gap with our classification and guidance tools.

Klíčová slova:

Database searching – Diagnostic medicine – Employment – Medicine and health sciences – Peer review – Research reporting guidelines – Statistical methods – Systematic reviews


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