Inference based on diagnostic measures from studies of new imaging devices.
Rationale and Objectives: Before using a new diagnostic imaging device regularly in a clinic, it should be studied using patients and radiologists. Often such studies report diagnostic performance in terms of sensitivity, specificity, area under the receiver operating characteristic curve (AUC), or...
| Published in: | Academic Radiology Vol. 20; no. 7; pp. 816 - 825 |
|---|---|
| Main Author: | |
| Format: | research Journal Article |
| Published: |
Elsevier B.V.
Jul2013
|
| Online Access: | View this record in EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=104177908&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 104177908 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 10766332 T4X jtl: Academic Radiology issn: 10766332 maglogo: N pubinfo: dt: Jul2013 vid: 20 iid: 7 pid: 467 pub: Elsevier B.V. place: New York, New York artinfo: ui: 104177908 NLM23643364 2012150222 10.1016/j.acra.2013.03.002 NLM23643364 104177908 ppf: 816 ppct: 9 formats: tig: atl: Inference based on diagnostic measures from studies of new imaging devices. aug: au: Samuelson, Frank W affil: U.S. Food and Drug Administration, 10903 New Hampshire Ave, Building 62, Room 3102, Silver Spring, MD, 20993-0002, USA. frank.samuelson@fda.hhs.gov sug: subj: Pharmacokinetics Breast Neoplasms Radiography Mammography Statistics and Numerical Data Signal Processing, Computer Assisted Diagnosis, Differential Diagnostic Imaging Methods Diagnostic Imaging Statistics and Numerical Data Female Human Mammography Methods Reproducibility of Results Sensitivity and Specificity Female ab: Rationale and Objectives: Before using a new diagnostic imaging device regularly in a clinic, it should be studied using patients and radiologists. Often such studies report diagnostic performance in terms of sensitivity, specificity, area under the receiver operating characteristic curve (AUC), or differences thereof. In this report we look at how these studies differ from actual future clinical practice and how those differences may affect reported performance measures. Materials and Methods: We review signal detection (receiver operating characteristic) theory and decision theory. We compare diagnostic measures from several published studies in medical imaging and examine how they relate to theory and each other. Results: We see that clinical decisions can be modeled using signal detection and decision theories. Sensitivity and specificity are inextricably linked with clinical factors, such as prevalence and costs. Imaging devices are used in many different ways in clinical practice, so that sensitivities, specificities, and AUCs measured in studies of new diagnostic imaging devices will differ from those in actual future clinical use. Conclusions: Measured sensitivities, specificities, and the directions of changes thereof are not necessarily consistent or reproducible across studies of new diagnostic devices. A change in the AUC, which should be independent of clinical costs or prevalence, is a consistent measure across similar studies, and a positive change in AUC is indicative of additional diagnostic information that will be available to radiologists in a future clinical environment. pubtype: Academic Journal doctype: research Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
|---|