title: Assessment of medical imaging and computer-assist systems: lessons from recent experience.
abstract: In the last 2 decades major advances have been made in the field of assessment methods for medical imaging and computer-assist systems through the use of the paradigm of the receiver operating characteristic (ROC) curve. In the most recent decade this methodology was extended to embrace the complication of reader variability through advances in the multiple-reader, multiple-case (MRMC) ROC measurement and analysis paradigm. Although this approach has been widely adopted by the imaging research community, some investigators appear averse to it, possibly from concern that it could place a greater burden on the scarce resources of patient cases and readers compared to the requirements of alternative methods. The present communication argues, however, that the MRMC ROC approach to assessment in the context of reader variability may be the most resource-efficient approach available. Moreover, alternative approaches may also be statistically uninterpretable with regard to estimated summary measures of performance and their uncertainties. The authors propose that the MRMC ROC approach be considered even more widely by the larger community with responsibilities for the introduction and dissemination of medical imaging technologies to society. General principles of study design are reviewed, and important contemporary clinical trials are used as examples.
authors.affiliation: Office of Science and Technology, Center for Devices and Radiological Health, Food and Drug Administraton, Rockville, MD 20857, USA.
authors.forename: Robert F
authors.initials: RF
authors.lastname: Wagner
authors.forename: Sergey V
authors.initials: SV
authors.lastname: Beiden
authors.forename: Gregory
authors.initials: G
authors.lastname: Campbell
authors.forename: Charles E
authors.initials: CE
authors.lastname: Metz
authors.forename: William M
authors.initials: WM
authors.lastname: Sacks
mesh_terms: D003936:Diagnosis, Computer-Assisted / Q000295:instrumentation* / Q000639:trends; D003952:Diagnostic Imaging / Q000295:instrumentation* / Q000639:trends; D004867:Equipment Design / Q000592:standards; D006801:Humans; D007221:Industry; D008327:Mammography / Q000379:methods; D012372:ROC Curve; D003074:Solitary Pulmonary Nodule / Q000175:diagnosis; D013673:Technology Assessment, Biomedical / Q000639:trends; D014481:United States; D014486:United States Food and Drug Administration