title: Simple ultrasound rules to distinguish between benign and malignant adnexal masses before surgery: prospective validation by IOTA group.
abstract: OBJECTIVE
  To prospectively assess the diagnostic performance of simple ultrasound rules to predict benignity/malignancy in an adnexal mass and to test the performance of the risk of malignancy index, two logistic regression models, and subjective assessment of ultrasonic findings by an experienced ultrasound examiner in adnexal masses for which the simple rules yield an inconclusive result.
  
  
  METHODS
  Prospective temporal and external validation of simple ultrasound rules to distinguish benign from malignant adnexal masses. The rules comprised five ultrasonic features (including shape, size, solidity, and results of colour Doppler examination) to predict a malignant tumour (M features) and five to predict a benign tumour (B features). If one or more M features were present in the absence of a B feature, the mass was classified as malignant. If one or more B features were present in the absence of an M feature, it was classified as benign. If both M features and B features were present, or if none of the features was present, the simple rules were inconclusive.
  
  
  METHODS
  19 ultrasound centres in eight countries.
  
  
  METHODS
  1938 women with an adnexal mass examined with ultrasound by the principal investigator at each centre with a standardised research protocol. Reference standard Histological classification of the excised adnexal mass as benign or malignant.
  
  
  METHODS
  Diagnostic sensitivity and specificity.
  
  
  RESULTS
  Of the 1938 patients with an adnexal mass, 1396 (72%) had benign tumours, 373 (19.2%) had primary invasive tumours, 111 (5.7%) had borderline malignant tumours, and 58 (3%) had metastatic tumours in the ovary. The simple rules yielded a conclusive result in 1501 (77%) masses, for which they resulted in a sensitivity of 92% (95% confidence interval 89% to 94%) and a specificity of 96% (94% to 97%). The corresponding sensitivity and specificity of subjective assessment were 91% (88% to 94%) and 96% (94% to 97%). In the 357 masses for which the simple rules yielded an inconclusive result and with available results of CA-125 measurements, the sensitivities were 89% (83% to 93%) for subjective assessment, 50% (42% to 58%) for the risk of malignancy index, 89% (83% to 93%) for logistic regression model 1, and 82% (75% to 87%) for logistic regression model 2; the corresponding specificities were 78% (72% to 83%), 84% (78% to 88%), 44% (38% to 51%), and 48% (42% to 55%). Use of the simple rules as a triage test and subjective assessment for those masses for which the simple rules yielded an inconclusive result gave a sensitivity of 91% (88% to 93%) and a specificity of 93% (91% to 94%), compared with a sensitivity of 90% (88% to 93%) and a specificity of 93% (91% to 94%) when subjective assessment was used in all masses.
  
  
  CONCLUSIONS
  The use of the simple rules has the potential to improve the management of women with adnexal masses. In adnexal masses for which the rules yielded an inconclusive result, subjective assessment of ultrasonic findings by an experienced ultrasound examiner was the most accurate diagnostic test; the risk of malignancy index and the two regression models were not useful.
authors.affiliation: Department of Obstetrics and Gynaecology, University Hospitals KU Leuven, 3000 Leuven, Belgium. dirk.timmerman@uzleuven.be
authors.forename: Dirk
authors.initials: D
authors.lastname: Timmerman
authors.forename: Lieveke
authors.initials: L
authors.lastname: Ameye
authors.forename: Daniela
authors.initials: D
authors.lastname: Fischerova
authors.forename: Elisabeth
authors.initials: E
authors.lastname: Epstein
authors.forename: Gian Benedetto
authors.initials: GB
authors.lastname: Melis
authors.forename: Stefano
authors.initials: S
authors.lastname: Guerriero
authors.forename: Caroline
authors.initials: C
authors.lastname: Van Holsbeke
authors.forename: Luca
authors.initials: L
authors.lastname: Savelli
authors.forename: Robert
authors.initials: R
authors.lastname: Fruscio
authors.forename: Andrea Alberto
authors.initials: AA
authors.lastname: Lissoni
authors.forename: Antonia Carla
authors.initials: AC
authors.lastname: Testa
authors.forename: Joan
authors.initials: J
authors.lastname: Veldman
authors.forename: Ignace
authors.initials: I
authors.lastname: Vergote
authors.forename: Sabine
authors.initials: S
authors.lastname: Van Huffel
authors.forename: Tom
authors.initials: T
authors.lastname: Bourne
authors.forename: Lil
authors.initials: L
authors.lastname: Valentin
mesh_terms: D000291:Adnexal Diseases / Q000000981:diagnostic imaging*; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002648:Child; D003937:Diagnosis, Differential; D055088:Early Detection of Cancer; D005260:Female; D005833:Genital Neoplasms, Female / Q000648:ultrastructure*; D006801:Humans; D008875:Middle Aged; D011300:Preoperative Care / Q000379:methods; D011446:Prospective Studies; D012015:Reference Standards; D018570:Risk Assessment; D012680:Sensitivity and Specificity; D014463:Ultrasonography; D055815:Young Adult