Metrology Standards for Quantitative Imaging Biomarkers

Although investigators in the imaging community have been active in developing and evaluating quantitative imaging biomarkers (QIBs), the development and implementation of QIBs have been hampered by the inconsistent or incorrect use of terminology or methods for technical performance and statistical...

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Published inRadiology Vol. 277; no. 3; pp. 813 - 825
Main Authors Sullivan, Daniel C., Obuchowski, Nancy A., Kessler, Larry G., Raunig, David L., Gatsonis, Constantine, Huang, Erich P., Kondratovich, Marina, McShane, Lisa M., Reeves, Anthony P., Barboriak, Daniel P., Guimaraes, Alexander R., Wahl, Richard L.
Format Journal Article
LanguageEnglish
Published United States Radiological Society of North America 01.12.2015
Subjects
Bias
Biomarkers - analysis
Diagnostic Imaging - methods
Original Research
Phantoms, Imaging
Reference Values
Reproducibility of Results
Terminology as Topic
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Summary:Although investigators in the imaging community have been active in developing and evaluating quantitative imaging biomarkers (QIBs), the development and implementation of QIBs have been hampered by the inconsistent or incorrect use of terminology or methods for technical performance and statistical concepts. Technical performance is an assessment of how a test performs in reference objects or subjects under controlled conditions. In this article, some of the relevant statistical concepts are reviewed, methods that can be used for evaluating and comparing QIBs are described, and some of the technical performance issues related to imaging biomarkers are discussed. More consistent and correct use of terminology and study design principles will improve clinical research, advance regulatory science, and foster better care for patients who undergo imaging studies.
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Author contributions: Guarantors of integrity of entire study, D.C.S., D.L.R.; study concepts/study design or data acquisition or data analysis/interpretation, all authors; manuscript drafting or manuscript revision for important intellectual content, all authors; approval of final version of submitted manuscript, all authors; agrees to ensure any questions related to the work are appropriately resolved, all authors; literature research, D.C.S., N.A.O., D.L.R., C.G., E.P.H., L.M.M., A.P.R., D.P.B.; experimental studies, M.K.; statistical analysis, N.A.O., C.G., E.P.H., M.K., L.M.M., A.R.G.; and manuscript editing, D.C.S., N.A.O., L.G.K., D.L.R., C.G., E.P.H., M.K., L.M.M., A.P.R., D.P.B., A.R.G.
ISSN:0033-8419
1527-1315
1527-1315
DOI:10.1148/radiol.2015142202