title: Multicentre external validation of IOTA prediction models and RMI by operators with varied training.
abstract: BACKGROUND
  Correct characterisation of ovarian tumours is critical to optimise patient care. The purpose of this study is to evaluate the diagnostic performance of the International Ovarian Tumour Analysis (IOTA) logistic regression model (LR2), ultrasound Simple Rules (SR), the Risk of Malignancy Index (RMI) and subjective assessment (SA) for preoperative characterisation of adnexal masses, when ultrasonography is performed by examiners with different background training and experience.
  
  
  METHODS
  A 2-year prospective multicentre cross-sectional study. Thirty-five level II ultrasound examiners contributed in three UK hospitals. Transvaginal ultrasonography was performed using a standardised approach. The final outcome was the surgical findings and histological diagnosis. To characterise the adnexal masses, the six-variable prediction model (LR2) with a cutoff of 0.1, the RMI with cutoff of 200, ten SR (five rules for malignancy and five rules for benignity) and SA were applied. The area under the curves (AUCs) for performance of LR2 and RMI were calculated. Diagnostic performance measures for all models assessed were sensitivity, specificity, positive and negative likelihood ratios (LR+ and LR-), and the diagnostic odds ratio (DOR).
  
  
  RESULTS
  Nine-hundred and sixty-two women with adnexal masses underwent transvaginal ultrasonography, whereas 255 had surgery. Prevalence of malignancy was 29% (49 primary invasive epithelial ovarian cancers, 18 borderline ovarian tumours, and 7 metastatic tumours). The AUCs for LR2 and RMI for all masses were 0.94 (95% confidence interval (CI): 0.89-0.97) and 0.90 (95% CI: 0.83-0.94), respectively. In premenopausal women, LR2-RMI difference was 0.09 (95% CI: 0.03-0.15) compared with -0.02 (95% CI: -0.08 to 0.04) in postmenopausal women. For all masses, the DORs for LR2, RMI, SR+SA (using SA when SR inapplicable), SR+MA (assuming malignancy when SR inapplicable), and SA were 62 (95% CI: 27-142), 43 (95% CI: 19-97), 109 (95% CI: 44-274), 66 (95% CI: 27-158), and 70 (95% CI: 30-163), respectively.
  
  
  CONCLUSIONS
  Overall, the test performance of IOTA prediction models and rules as well as the RMI was maintained in examiners with varying levels of training and experience.
authors.affiliation: Department of Cancer and Surgery, Imperial College London, Hammersmith Campus, Du Cane Road, London W12 0HS, UK. a.sayasneh@imperial.ac.uk
authors.forename: A
authors.initials: A
authors.lastname: Sayasneh
authors.forename: L
authors.initials: L
authors.lastname: Wynants
authors.forename: J
authors.initials: J
authors.lastname: Preisler
authors.forename: J
authors.initials: J
authors.lastname: Kaijser
authors.forename: S
authors.initials: S
authors.lastname: Johnson
authors.forename: C
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authors.lastname: Stalder
authors.forename: R
authors.initials: R
authors.lastname: Husicka
authors.forename: Y
authors.initials: Y
authors.lastname: Abdallah
authors.forename: F
authors.initials: F
authors.lastname: Raslan
authors.forename: A
authors.initials: A
authors.lastname: Drought
authors.forename: A A
authors.initials: AA
authors.lastname: Smith
authors.forename: S
authors.initials: S
authors.lastname: Ghaem-Maghami
authors.forename: E
authors.initials: E
authors.lastname: Epstein
authors.forename: B
authors.initials: B
authors.lastname: Van Calster
authors.forename: D
authors.initials: D
authors.lastname: Timmerman
authors.forename: T
authors.initials: T
authors.lastname: Bourne
mesh_terms: D000328:Adult; D000077216:Carcinoma, Ovarian Epithelial; D002983:Clinical Competence; D003430:Cross-Sectional Studies; D004501:Education, Medical; D005260:Female; D006305:Health Status Indicators; D006801:Humans; D038622:Internationality; D008875:Middle Aged; D008962:Models, Theoretical; D009375:Neoplasms, Glandular and Epithelial / Q000175:diagnosis* / Q000000981:diagnostic imaging / Q000453:epidemiology / Q000209:etiology; D015588:Observer Variation; D010051:Ovarian Neoplasms / Q000175:diagnosis* / Q000000981:diagnostic imaging / Q000453:epidemiology / Q000209:etiology; D015995:Prevalence; D011379:Prognosis; D018570:Risk Assessment; D014463:Ultrasonography