Assessment of medical imaging and computer-assist systems: Lessons from recent experience

被引:61
作者
Wagner, RF
Beiden, SV
Campbell, G
Metz, CE
Sacks, WM
机构
[1] US FDA, Ctr Devices & Radiol Hlth, Off Sci & Technol, Rockville, MD 20857 USA
[2] US FDA, Ctr Devices & Radiol Hlth, Off Surveillance & Biometr, Rockville, MD 20857 USA
[3] US FDA, Ctr Devices & Radiol Hlth, Off Device Evaluat, Rockville, MD 20857 USA
[4] Univ Chicago, Dept Radiol, Rossmann Labs, Chicago, IL 60637 USA
关键词
computers; diagnostic aid; diagnostic radiology; observer performance; receiver operating characteristic curve (ROC);
D O I
10.1016/S1076-6332(03)80560-3
中图分类号
R8 [特种医学]; R445 [影像诊断学];
学科分类号
1002 ; 100207 ; 1009 ;
摘要
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.
引用
收藏
页码:1264 / 1277
页数:14
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