title: Prospective validation of two mathematical models to calculate the risk of endometrial malignancy in patients with postmenopausal bleeding and sonographic endometrial thickness ≥4.5 mm.
abstract: To prospectively validate two mathematical models for calculating the likelihood of endometrial malignancy in patients with postmenopausal bleeding (PMPB), sonographic endometrial thickness (ET) ≥4.5 mm and no fluid in the uterine cavity.
  
  
  
  This is a prospective observational diagnostic validation study performed in a PMPB clinic in a university hospital. Of 860 consecutive patients, 350 fulfilled our inclusion criteria. A standardized history was taken, clinical and transvaginal grey scale and power Doppler ultrasound examinations were performed following a research protocol. The percentage vascularized area of the endometrium at power Doppler examination (VI) was calculated using computer software. The colour content of the endometrial scan was estimated subjectively on a visual analogue scale (VAS). Gold standard was the histological diagnosis of the endometrium. Main outcome measures were area under the receiver operating characteristic curve (AUC), sensitivity and specificity when using the cut-offs suggested in the original study, and calibration curves.
  
  
  
  Eighty (23%) patients had malignant endometrium. The performance of the models was similar to that in the original study. The model including patient's age, use of hormone therapy, ET and VAS performed best (AUC 0.91; 95% confidence interval [CI] 0.87-0.95; sensitivity 70%, specificity 93%). The model including ET, VI, patient's age and hormone therapy use had AUC 0.89 (95% CI 0.84-0.93; sensitivity 79%; specificity 81%). ET had AUC 0.83 (95% CI 0.78-0.88). The models were reasonably well calibrated.
  
  
  
  On prospective validation both models retained their diagnostic performance. This suggests that they are robust and potentially clinically useful for individualized patient management.
authors.affiliation: Department of Obstetrics and Gynecology, Skåne University Hospital Malmö, Lund University, S-20502 Malmö, Sweden. Electronic address: Povilas.Sladkevicius@med.lu.se.
authors.forename: Povilas
authors.initials: P
authors.lastname: Sladkevicius
authors.affiliation: Department of Obstetrics and Gynecology, Skåne University Hospital Malmö, Lund University, S-20502 Malmö, Sweden. Electronic address: Lil.Valentin@med.lu.se.
authors.forename: Lil
authors.initials: L
authors.lastname: Valentin
mesh_terms: D000230:Adenocarcinoma / Q000000981:diagnostic imaging*; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000925:Anticoagulants / Q000627:therapeutic use; D019540:Area Under Curve; D055088:Early Detection of Cancer; D016889:Endometrial Neoplasms / Q000150:complications* / Q000000981:diagnostic imaging; D004717:Endometrium / Q000000981:diagnostic imaging; D005260:Female; D020249:Hormone Replacement Therapy; D006801:Humans; D008875:Middle Aged; D008962:Models, Theoretical; D017698:Postmenopause / Q000502:physiology*; D011446:Prospective Studies; D012372:ROC Curve; D018608:Ultrasonography, Doppler; D014592:Uterine Hemorrhage / Q000209:etiology*
chemical_list: D000925:Anticoagulants
keywords: Doppler ultrasound; Endometrial neoplasms; Logistic models; Postmenopausal bleeding; Ultrasonography; Validation study