title: Reading protocol for dynamic contrast-enhanced MR images of the breast: sensitivity and specificity analysis.
abstract: OBJECTIVE
  To prospectively determine sensitivity and specificity of breast magnetic resonance (MR) imaging in a screening and symptomatic population by using independent double reading, with histologic or cytologic results or a minimum 18-month follow-up as the standard.
  
  
  METHODS
  Informed consent and ethical approval were obtained. Reader performance was analyzed in 44 radiologists at 18 centers from 1541 examinations, including 1441 screening examinations in 638 high-risk women aged 24-51 years (mean, 40.5 years) and 100 examinations in symptomatic women aged 23-81 years (mean, 49.2 years). A screening protocol of dynamic T1-weighted three-dimensional imaging and 0.2 mmol/kg gadolinium-based intravenous contrast agent was used. Logistic and Poisson regressions were used to analyze reader performance in relation to experience. Correlation between readers was determined with kappa statistics. Sensitivity and specificity were analyzed according to reader, field strength, machine type, and histologic results.
  
  
  RESULTS
  The proportion of studies with lesions analyzed reduced significantly with reader experience (odds ratio, 0.84 per 6 months; P < .001), and number of regions per lesion analyzed also diminished (incidence rate ratio, 0.98 per 6 months; P = .047). The two readers for each study agreed 87% of the time, with a moderately good kappa statistic of 0.52 (95% confidence interval [CI]: 0.45, 0.58). By taking the reading with the highest score (most likely to be malignant) from each double-read study, sensitivity was 91% (95% CI: 83%, 96%) and specificity was 81% (95% CI: 79%, 83%). Single readings had 7% lower sensitivity (95% CI: 4%, 11%) and 7% higher specificity (95% CI: 6%, 7%). Sensitivity did not differ between MR imager manufacturers or between 1.0- and 1.5-T field strength, but there were significant differences in specificity for machine type (P = .001) and for field strength adjusted for manufacturer (P = .001). Specificity, but not sensitivity, was higher in women younger than 50 years (P = .02).
  
  
  CONCLUSIONS
  Independent double reading by 44 radiologists blinded to mammography results showed sensitivity and specificity acceptable for screening; sensitivity was higher when two readings were used, at the cost of specificity. Interreader correlation was moderately good, and evidence of learning was seen. Equipment manufacturer, field strength, and age affected specificity but not sensitivity.
authors.affiliation: Department of Radiology, Addenbrooke's Hospital, Cambridge, England.
authors.forename: Ruth M L
authors.initials: RM
authors.lastname: Warren
authors.forename: Linda
authors.initials: L
authors.lastname: Pointon
authors.forename: Deborah
authors.initials: D
authors.lastname: Thompson
authors.forename: Rebecca
authors.initials: R
authors.lastname: Hoff
authors.forename: Fiona J
authors.initials: FJ
authors.lastname: Gilbert
authors.forename: Anwar
authors.initials: A
authors.lastname: Padhani
authors.forename: Doug
authors.initials: D
authors.lastname: Easton
authors.forename: Sunil R
authors.initials: SR
authors.lastname: Lakhani
authors.forename: Martin O
authors.initials: MO
authors.lastname: Leach
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001941:Breast Diseases / Q000175:diagnosis*; D002983:Clinical Competence; D003287:Contrast Media; D005260:Female; D019786:Gadolinium DTPA; D006801:Humans; D021621:Imaging, Three-Dimensional; D016015:Logistic Models; D008279:Magnetic Resonance Imaging / Q000295:instrumentation; D008327:Mammography; D008875:Middle Aged; D016012:Poisson Distribution; D011446:Prospective Studies; D012680:Sensitivity and Specificity
chemical_list: D003287:Contrast Media; D019786:Gadolinium DTPA