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Am J Obstet Gynecol. 2016 Apr;214(4):424-437. doi: 10.1016/j.ajog.2016.01.007. Epub 2016 Jan 19.

Predicting the risk of malignancy in adnexal masses based on the Simple Rules from the International Ovarian Tumor Analysis group.

Author information

1
Department of Development and Regeneration, KU Leuven, Leuven, Belgium; Department of Obstetrics and Gynecology, University Hospitals Leuven, Leuven, Belgium. Electronic address: dirk.timmerman@uzleuven.be.
2
Department of Development and Regeneration, KU Leuven, Leuven, Belgium.
3
Department of Oncology, Catholic University of the Sacred Heart, Rome, Italy.
4
Department of Obstetrics and Gynecology, S. Orsola-Malpighi Hospital, University of Bologna, Bologna, Italy.
5
Gynecological Oncology Center, Department of Obstetrics and Gynecology, Charles University, Prague, Czech Republic.
6
Department of Development and Regeneration, KU Leuven, Leuven, Belgium; Department of Obstetrics and Gynecology, University Hospitals Leuven, Leuven, Belgium.
7
Department of Electrical Engineering-ESAT, Stadius Center for Dynamical Systems, Signal Processing and Data Analytics, KU Leuven, Leuven, Belgium; iMinds Medical IT Department, KU Leuven, Leuven, Belgium.
8
Department of Obstetrics and Gynecology, University Hospitals Leuven, Leuven, Belgium; Department of Obstetrics and Gynecology, Ziekenhuis Oost-Limburg, Genk, Belgium.
9
Departments of Obstetrics and Gynecology at Karolinska University Hospital, Stockholm, Sweden.
10
Preventive Gynecology Unit, Division of Gynecology, European Institute of Oncology, Milan, Italy.
11
Department of Obstetrics and Gynecology, University Hospitals Leuven, Leuven, Belgium; Department of Gynecology and Obstetrics, Ikazia Hospital, Rotterdam, The Netherlands.
12
First Department of Gynecological Oncology and Gynecology, Medical University of Lublin, Lublin, Poland.
13
Department of Obstetrics and Gynecology, Azienda Ospedaliero Universitaria di Cagliari, Cagliari, Italy.
14
Clinic of Obstetrics and Gynecology, University of Milan-Bicocca, San Gerardo Hospital, Monza, Italy.
15
Department of Obstetrics and Gynecology, Clinical Sciences Institute L. Sacco, University of Milan, Milan, Italy.
16
Department of Obstetrics and Gynecology, University of Udine, Udine, Italy.
17
Department of Oncology, KU Leuven, Leuven, Belgium; Department of Obstetrics and Gynecology, University Hospitals Leuven, Leuven, Belgium.
18
Department of Development and Regeneration, KU Leuven, Leuven, Belgium; Department of Obstetrics and Gynecology, University Hospitals Leuven, Leuven, Belgium; Queen Charlotte's and Chelsea Hospital, Imperial College, London, United Kingdom.
19
Skåne University Hospital Malmö, Lund University, Malmö, Sweden.

Abstract

BACKGROUND:

Accurate methods to preoperatively characterize adnexal tumors are pivotal for optimal patient management. A recent metaanalysis concluded that the International Ovarian Tumor Analysis algorithms such as the Simple Rules are the best approaches to preoperatively classify adnexal masses as benign or malignant.

OBJECTIVE:

We sought to develop and validate a model to predict the risk of malignancy in adnexal masses using the ultrasound features in the Simple Rules.

STUDY DESIGN:

This was an international cross-sectional cohort study involving 22 oncology centers, referral centers for ultrasonography, and general hospitals. We included consecutive patients with an adnexal tumor who underwent a standardized transvaginal ultrasound examination and were selected for surgery. Data on 5020 patients were recorded in 3 phases from 2002 through 2012. The 5 Simple Rules features indicative of a benign tumor (B-features) and the 5 features indicative of malignancy (M-features) are based on the presence of ascites, tumor morphology, and degree of vascularity at ultrasonography. Gold standard was the histopathologic diagnosis of the adnexal mass (pathologist blinded to ultrasound findings). Logistic regression analysis was used to estimate the risk of malignancy based on the 10 ultrasound features and type of center. The diagnostic performance was evaluated by area under the receiver operating characteristic curve, sensitivity, specificity, positive likelihood ratio (LR+), negative likelihood ratio (LR-), positive predictive value (PPV), negative predictive value (NPV), and calibration curves.

RESULTS:

Data on 4848 patients were analyzed. The malignancy rate was 43% (1402/3263) in oncology centers and 17% (263/1585) in other centers. The area under the receiver operating characteristic curve on validation data was very similar in oncology centers (0.917; 95% confidence interval, 0.901-0.931) and other centers (0.916; 95% confidence interval, 0.873-0.945). Risk estimates showed good calibration. In all, 23% of patients in the validation data set had a very low estimated risk (<1%) and 48% had a high estimated risk (≥30%). For the 1% risk cutoff, sensitivity was 99.7%, specificity 33.7%, LR+ 1.5, LR- 0.010, PPV 44.8%, and NPV 98.9%. For the 30% risk cutoff, sensitivity was 89.0%, specificity 84.7%, LR+ 5.8, LR- 0.13, PPV 75.4%, and NPV 93.9%.

CONCLUSION:

Quantification of the risk of malignancy based on the Simple Rules has good diagnostic performance both in oncology centers and other centers. A simple classification based on these risk estimates may form the basis of a clinical management system. Patients with a high risk may benefit from surgery by a gynecological oncologist, while patients with a lower risk may be managed locally.

KEYWORDS:

International Ovarian Tumor Analysis; Simple Rules; adnexa; color Doppler; diagnosis; diagnostic algorithm; logistic regression analysis; ovarian cancer; ovarian neoplasms; preoperative evaluation; risk assessment; ultrasonography

PMID:
26800772
DOI:
10.1016/j.ajog.2016.01.007
[Indexed for MEDLINE]
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