title: Statistical Issues in Testing Conformance with the Quantitative Imaging Biomarker Alliance (QIBA) Profile Claims.
abstract: A major initiative of the Quantitative Imaging Biomarker Alliance is to develop standards-based documents called "Profiles," which describe one or more technical performance claims for a given imaging modality. The term "actor" denotes any entity (device, software, or person) whose performance must meet certain specifications for the claim to be met. The objective of this paper is to present the statistical issues in testing actors' conformance with the specifications. In particular, we present the general rationale and interpretation of the claims, the minimum requirements for testing whether an actor achieves the performance requirements, the study designs used for testing conformity, and the statistical analysis plan. We use three examples to illustrate the process: apparent diffusion coefficient in solid tumors measured by MRI, change in Perc 15 as a biomarker for the progression of emphysema, and percent change in solid tumor volume by computed tomography as a biomarker for lung cancer progression.
authors.affiliation: Quantitative Health Sciences, Cleveland Clinic Foundation, 9500 Euclid Ave, Cleveland, OH 44195. Electronic address: obuchon@ccf.org.
authors.forename: Nancy A
authors.initials: NA
authors.lastname: Obuchowski
authors.affiliation: Elucid Bioimaging Inc., Wenham, Massachusetts.
authors.forename: Andrew
authors.initials: A
authors.lastname: Buckler
authors.affiliation: Department of Radiology, University of Washington, Seattle, Washington.
authors.forename: Paul
authors.initials: P
authors.lastname: Kinahan
authors.affiliation: National Institute of Standards and Technology, Gaithersburg, Maryland.
authors.forename: Heather
authors.initials: H
authors.lastname: Chen-Mayer
authors.affiliation: Food and Drug Administration/CDRH, Silver Spring, Maryland.
authors.forename: Nicholas
authors.initials: N
authors.lastname: Petrick
authors.affiliation: Duke University School of Medicine, Durham, North Carolina.
authors.forename: Daniel P
authors.initials: DP
authors.lastname: Barboriak
authors.affiliation: Quantitative Health Sciences, Cleveland Clinic Foundation, 9500 Euclid Ave, Cleveland, OH 44195.
authors.forename: Jennifer
authors.initials: J
authors.lastname: Bullen
authors.affiliation: Duke University School of Medicine, Durham, North Carolina.
authors.forename: Huiman
authors.initials: H
authors.lastname: Barnhart
authors.affiliation: Duke University School of Medicine, Durham, North Carolina.
authors.forename: Daniel C
authors.initials: DC
authors.lastname: Sullivan
mesh_terms: D015415:Biomarkers; D003952:Diagnostic Imaging / Q000706:statistics & numerical data*; D004646:Emphysema / Q000175:diagnosis; D006801:Humans; D008175:Lung Neoplasms / Q000000981:diagnostic imaging; D008279:Magnetic Resonance Imaging / Q000706:statistics & numerical data; D012107:Research Design / Q000706:statistics & numerical data*; D014057:Tomography, X-Ray Computed / Q000706:statistics & numerical data
chemical_list: D015415:Biomarkers
keywords: QIBA; bias; linearity; precision; quantitative imaging biomarker; repeatability; total deviation index