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 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.
From the Department of Radiology, Duke University Medical Center, Box 2715, Durham, NC 27710 (D.C.S., D.P.B.); Department of Quantitative Health Sciences, Cleveland Clinic Foundation, Cleveland, Ohio (N.A.O.); Department of Public Health, University of Washington, Seattle, Wash (L.G.K.); Department of Informatics, ICON Medical, Washington, Pa (D.L.R.); Center for Statistical Sciences, Brown University, Providence, RI (C.G.); National Cancer Institute, Bethesda, Md (E.P.H., L.M.M.); Center for Devices and Radiological Health, U.S. Food and Drug Administration, White Oak, Md (M.K.); Department of Electrical and Computer Engineering, Cornell University, Ithaca, NY (A.P.R.); Department of Radiology, Oregon Health & Science University, Portland, Ore (A.R.G.); and Mallinckrodt Institute of Radiology, Washington University School of Medicine, St Louis, Mo (R.L.W.).
Daniel C
DC
Sullivan
From the Department of Radiology, Duke University Medical Center, Box 2715, Durham, NC 27710 (D.C.S., D.P.B.); Department of Quantitative Health Sciences, Cleveland Clinic Foundation, Cleveland, Ohio (N.A.O.); Department of Public Health, University of Washington, Seattle, Wash (L.G.K.); Department of Informatics, ICON Medical, Washington, Pa (D.L.R.); Center for Statistical Sciences, Brown University, Providence, RI (C.G.); National Cancer Institute, Bethesda, Md (E.P.H., L.M.M.); Center for Devices and Radiological Health, U.S. Food and Drug Administration, White Oak, Md (M.K.); Department of Electrical and Computer Engineering, Cornell University, Ithaca, NY (A.P.R.); Department of Radiology, Oregon Health & Science University, Portland, Ore (A.R.G.); and Mallinckrodt Institute of Radiology, Washington University School of Medicine, St Louis, Mo (R.L.W.).
Nancy A
NA
Obuchowski
From the Department of Radiology, Duke University Medical Center, Box 2715, Durham, NC 27710 (D.C.S., D.P.B.); Department of Quantitative Health Sciences, Cleveland Clinic Foundation, Cleveland, Ohio (N.A.O.); Department of Public Health, University of Washington, Seattle, Wash (L.G.K.); Department of Informatics, ICON Medical, Washington, Pa (D.L.R.); Center for Statistical Sciences, Brown University, Providence, RI (C.G.); National Cancer Institute, Bethesda, Md (E.P.H., L.M.M.); Center for Devices and Radiological Health, U.S. Food and Drug Administration, White Oak, Md (M.K.); Department of Electrical and Computer Engineering, Cornell University, Ithaca, NY (A.P.R.); Department of Radiology, Oregon Health & Science University, Portland, Ore (A.R.G.); and Mallinckrodt Institute of Radiology, Washington University School of Medicine, St Louis, Mo (R.L.W.).
Larry G
LG
Kessler
From the Department of Radiology, Duke University Medical Center, Box 2715, Durham, NC 27710 (D.C.S., D.P.B.); Department of Quantitative Health Sciences, Cleveland Clinic Foundation, Cleveland, Ohio (N.A.O.); Department of Public Health, University of Washington, Seattle, Wash (L.G.K.); Department of Informatics, ICON Medical, Washington, Pa (D.L.R.); Center for Statistical Sciences, Brown University, Providence, RI (C.G.); National Cancer Institute, Bethesda, Md (E.P.H., L.M.M.); Center for Devices and Radiological Health, U.S. Food and Drug Administration, White Oak, Md (M.K.); Department of Electrical and Computer Engineering, Cornell University, Ithaca, NY (A.P.R.); Department of Radiology, Oregon Health & Science University, Portland, Ore (A.R.G.); and Mallinckrodt Institute of Radiology, Washington University School of Medicine, St Louis, Mo (R.L.W.).
David L
DL
Raunig
From the Department of Radiology, Duke University Medical Center, Box 2715, Durham, NC 27710 (D.C.S., D.P.B.); Department of Quantitative Health Sciences, Cleveland Clinic Foundation, Cleveland, Ohio (N.A.O.); Department of Public Health, University of Washington, Seattle, Wash (L.G.K.); Department of Informatics, ICON Medical, Washington, Pa (D.L.R.); Center for Statistical Sciences, Brown University, Providence, RI (C.G.); National Cancer Institute, Bethesda, Md (E.P.H., L.M.M.); Center for Devices and Radiological Health, U.S. Food and Drug Administration, White Oak, Md (M.K.); Department of Electrical and Computer Engineering, Cornell University, Ithaca, NY (A.P.R.); Department of Radiology, Oregon Health & Science University, Portland, Ore (A.R.G.); and Mallinckrodt Institute of Radiology, Washington University School of Medicine, St Louis, Mo (R.L.W.).
Constantine
C
Gatsonis
From the Department of Radiology, Duke University Medical Center, Box 2715, Durham, NC 27710 (D.C.S., D.P.B.); Department of Quantitative Health Sciences, Cleveland Clinic Foundation, Cleveland, Ohio (N.A.O.); Department of Public Health, University of Washington, Seattle, Wash (L.G.K.); Department of Informatics, ICON Medical, Washington, Pa (D.L.R.); Center for Statistical Sciences, Brown University, Providence, RI (C.G.); National Cancer Institute, Bethesda, Md (E.P.H., L.M.M.); Center for Devices and Radiological Health, U.S. Food and Drug Administration, White Oak, Md (M.K.); Department of Electrical and Computer Engineering, Cornell University, Ithaca, NY (A.P.R.); Department of Radiology, Oregon Health & Science University, Portland, Ore (A.R.G.); and Mallinckrodt Institute of Radiology, Washington University School of Medicine, St Louis, Mo (R.L.W.).
Erich P
EP
Huang
From the Department of Radiology, Duke University Medical Center, Box 2715, Durham, NC 27710 (D.C.S., D.P.B.); Department of Quantitative Health Sciences, Cleveland Clinic Foundation, Cleveland, Ohio (N.A.O.); Department of Public Health, University of Washington, Seattle, Wash (L.G.K.); Department of Informatics, ICON Medical, Washington, Pa (D.L.R.); Center for Statistical Sciences, Brown University, Providence, RI (C.G.); National Cancer Institute, Bethesda, Md (E.P.H., L.M.M.); Center for Devices and Radiological Health, U.S. Food and Drug Administration, White Oak, Md (M.K.); Department of Electrical and Computer Engineering, Cornell University, Ithaca, NY (A.P.R.); Department of Radiology, Oregon Health & Science University, Portland, Ore (A.R.G.); and Mallinckrodt Institute of Radiology, Washington University School of Medicine, St Louis, Mo (R.L.W.).
Marina
M
Kondratovich
From the Department of Radiology, Duke University Medical Center, Box 2715, Durham, NC 27710 (D.C.S., D.P.B.); Department of Quantitative Health Sciences, Cleveland Clinic Foundation, Cleveland, Ohio (N.A.O.); Department of Public Health, University of Washington, Seattle, Wash (L.G.K.); Department of Informatics, ICON Medical, Washington, Pa (D.L.R.); Center for Statistical Sciences, Brown University, Providence, RI (C.G.); National Cancer Institute, Bethesda, Md (E.P.H., L.M.M.); Center for Devices and Radiological Health, U.S. Food and Drug Administration, White Oak, Md (M.K.); Department of Electrical and Computer Engineering, Cornell University, Ithaca, NY (A.P.R.); Department of Radiology, Oregon Health & Science University, Portland, Ore (A.R.G.); and Mallinckrodt Institute of Radiology, Washington University School of Medicine, St Louis, Mo (R.L.W.).
Lisa M
LM
McShane
From the Department of Radiology, Duke University Medical Center, Box 2715, Durham, NC 27710 (D.C.S., D.P.B.); Department of Quantitative Health Sciences, Cleveland Clinic Foundation, Cleveland, Ohio (N.A.O.); Department of Public Health, University of Washington, Seattle, Wash (L.G.K.); Department of Informatics, ICON Medical, Washington, Pa (D.L.R.); Center for Statistical Sciences, Brown University, Providence, RI (C.G.); National Cancer Institute, Bethesda, Md (E.P.H., L.M.M.); Center for Devices and Radiological Health, U.S. Food and Drug Administration, White Oak, Md (M.K.); Department of Electrical and Computer Engineering, Cornell University, Ithaca, NY (A.P.R.); Department of Radiology, Oregon Health & Science University, Portland, Ore (A.R.G.); and Mallinckrodt Institute of Radiology, Washington University School of Medicine, St Louis, Mo (R.L.W.).
Anthony P
AP
Reeves
From the Department of Radiology, Duke University Medical Center, Box 2715, Durham, NC 27710 (D.C.S., D.P.B.); Department of Quantitative Health Sciences, Cleveland Clinic Foundation, Cleveland, Ohio (N.A.O.); Department of Public Health, University of Washington, Seattle, Wash (L.G.K.); Department of Informatics, ICON Medical, Washington, Pa (D.L.R.); Center for Statistical Sciences, Brown University, Providence, RI (C.G.); National Cancer Institute, Bethesda, Md (E.P.H., L.M.M.); Center for Devices and Radiological Health, U.S. Food and Drug Administration, White Oak, Md (M.K.); Department of Electrical and Computer Engineering, Cornell University, Ithaca, NY (A.P.R.); Department of Radiology, Oregon Health & Science University, Portland, Ore (A.R.G.); and Mallinckrodt Institute of Radiology, Washington University School of Medicine, St Louis, Mo (R.L.W.).
Daniel P
DP
Barboriak
From the Department of Radiology, Duke University Medical Center, Box 2715, Durham, NC 27710 (D.C.S., D.P.B.); Department of Quantitative Health Sciences, Cleveland Clinic Foundation, Cleveland, Ohio (N.A.O.); Department of Public Health, University of Washington, Seattle, Wash (L.G.K.); Department of Informatics, ICON Medical, Washington, Pa (D.L.R.); Center for Statistical Sciences, Brown University, Providence, RI (C.G.); National Cancer Institute, Bethesda, Md (E.P.H., L.M.M.); Center for Devices and Radiological Health, U.S. Food and Drug Administration, White Oak, Md (M.K.); Department of Electrical and Computer Engineering, Cornell University, Ithaca, NY (A.P.R.); Department of Radiology, Oregon Health & Science University, Portland, Ore (A.R.G.); and Mallinckrodt Institute of Radiology, Washington University School of Medicine, St Louis, Mo (R.L.W.).
Alexander R
AR
Guimaraes
From the Department of Radiology, Duke University Medical Center, Box 2715, Durham, NC 27710 (D.C.S., D.P.B.); Department of Quantitative Health Sciences, Cleveland Clinic Foundation, Cleveland, Ohio (N.A.O.); Department of Public Health, University of Washington, Seattle, Wash (L.G.K.); Department of Informatics, ICON Medical, Washington, Pa (D.L.R.); Center for Statistical Sciences, Brown University, Providence, RI (C.G.); National Cancer Institute, Bethesda, Md (E.P.H., L.M.M.); Center for Devices and Radiological Health, U.S. Food and Drug Administration, White Oak, Md (M.K.); Department of Electrical and Computer Engineering, Cornell University, Ithaca, NY (A.P.R.); Department of Radiology, Oregon Health & Science University, Portland, Ore (A.R.G.); and Mallinckrodt Institute of Radiology, Washington University School of Medicine, St Louis, Mo (R.L.W.).
Richard L
RL
Wahl
D015982:Bias; D015415:Biomarkers / Q000032:analysis*; D003952:Diagnostic Imaging / Q000379:methods*; D019047:Phantoms, Imaging; D012016:Reference Values; D015203:Reproducibility of Results; D009626:Terminology as Topic
D015415:Biomarkers