Antonia Carla Testa

Logistic Regression Model to Distinguish Between the Benign and Malignant Adnexal Mass Before Surgery: A Multicenter Study by the International Ovarian Tumor Analysis Group

PURPOSE To collect data for the development of a more universally useful logistic regression model to distinguish between a malignant and benign adnexal tumor before surgery. PATIENTS AND METHODS Patients had at least one persistent mass. More than 50 clinical and sonographic end points were defined and recorded for analysis. The outcome measure was the histologic classification of excised tissues as malignant or benign. RESULTS Data from 1,066 patients recruited from nine European centers were included in the analysis; 800 patients (75%) had benign tumors and 266 (25%) had malignant tumors. The most useful independent prognostic variables for the logistic regression model were as follows: (1) personal history of ovarian cancer, (2) hormonal therapy, (3) age, (4) maximum diameter of lesion, (5) pain, (6) ascites, (7) blood flow within a solid papillary projection, (8) presence of an entirely solid tumor, (9) maximal diameter of solid component, (10) irregular internal cyst walls, (11) acoustic shadows, and (12) a color score of intratumoral blood flow. The model containing all 12 variables (M1) gave an area under the receiver operating characteristic curve of 0.95 for the development data set (n = 754 patients). The corresponding value for the test data set (n = 312 patients) was 0.94; and a probability cutoff value of .10 gave a sensitivity of 93% and a specificity of 76%. CONCLUSION Because the model was constructed from multicenter data, it is more likely to be generally applicable. The effectiveness of the model will be tested prospectively at different centers.

Simple ultrasound-based rules for the diagnosis of ovarian cancer

To derive simple and clinically useful ultrasound‐based rules for discriminating between benign and malignant adnexal masses.

Simple ultrasound rules to distinguish between benign and malignant adnexal masses before surgery: prospective validation by IOTA group

Objectives 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. Design 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. Setting 19 ultrasound centres in eight countries. Participants 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. Main outcome measures 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.

Ovarian cancer prediction in adnexal masses using ultrasound‐based logistic regression models: a temporal and external validation study by the IOTA group

The aims of the study were to temporally and externally validate the diagnostic performance of two logistic regression models containing clinical and ultrasound variables in order to estimate the risk of malignancy in adnexal masses, and to compare the results with the subjective interpretation of ultrasound findings carried out by an experienced ultrasound examiner (‘subjective assessment’).

Endometriomas: their ultrasound characteristics

To describe the ultrasound characteristics of endometriomas in pre‐ and postmenopausal patients and to develop rules that characterize endometriomas.

Diagnostic accuracy of transvaginal ultrasound examination for assigning a specific diagnosis to adnexal masses

To determine the sensitivity and specificity of subjective evaluation of gray‐scale and Doppler ultrasound findings (here called pattern recognition) when used by experienced ultrasound examiners with regard to making a specific diagnosis of adnexal masses.

Preoperative local staging of endometrial cancer: transvaginal sonography vs. magnetic resonance imaging.

To compare the accuracy of transvaginal sonography (TVS) and magnetic resonance imaging (MRI) in the preoperative staging of endometrial carcinoma.

Inclusion of CA-125 Does Not Improve Mathematical Models Developed to Distinguish Between Benign and Malignant Adnexal Tumors

PURPOSE To test the value of serum CA-125 measurements alone or as part of a multimodal strategy to distinguish between malignant and benign ovarian tumors before surgery based on a large prospective multicenter study (International Ovarian Tumor Analysis). PATIENTS AND METHODS Patients with at least one persistent ovarian mass preoperatively underwent transvaginal ultrasonography using gray scale imaging to assess tumor morphology and color Doppler imaging to obtain indices of blood flow. RESULTS Data from 809 patients recruited from nine centers were included in the analysis; 567 patients (70%) had benign tumors and 242 (30%) had malignant tumors-of these 152 were primary invasive (62.8%), 52 were borderline malignant (21.5%), and 38 were metastatic (15.7%). A logistic regression model including CA-125 (M2) resulted in an area under the receiver operating characteristic curve (AUC) of 0.934 and did not outperform a published (M1) without serum CA-125 information (AUC, 0.936). Specifically designed new models including CA-125 for premenopausal women (M3) and for postmenopausal women (M4) did not perform significantly better than the model without CA-125 (M1; AUC, 0.891 v AUC, 0.911 and AUC, 0.975 v AUC, 0.949, respectively). In postmenopausal patients, serum CA-125 alone (AUC, 0.920) and the risk of malignancy index (AUC, 0.924) performed very well. Results were very similar when the models were prospectively tested on a group of 345 new patients with adnexal masses of whom 126 had malignant tumors (37%). CONCLUSION Adding information on CA-125 to clinical information and ultrasound information does not improve discrimination of mathematical models between benign and malignant adnexal masses.

The duration of hypertension in the puerperium of preeclamptic women: Relationship with renal impairment and week of delivery

OBJECTIVE The purpose of the study was to determine whether the duration of hypertension in the puerperium of preeclamptic women was related to certain clinical features of disease severity. STUDY DESIGN We studied 269 singleton pregnancies divided into two groups: 159 with gestational hypertension and 110 with preeclampsia. The normalization time of blood pressure in puerperium was estimated as the interval between the delivery day and the first day when each of two to four self-measurements per day of diastolic blood pressure was observed to be < or = 80 mm Hg for at least 3 consecutive days. RESULTS Normalization time was shorter in gestational hypertension than in preeclampsia (6 +/- 5.5 [means +/- SD] vs 16 +/- 9.5, respectively, p < 0.0001). Normalization time of gestational hypertension showed a significant correlation with uric acid (r = 0.20, p < 0.025); normalization time of preeclampsia displayed significant correlations with the week of delivery (r = -0.34, p < 0.005), uric acid (r = 0.34, p < 0.025), and urea nitrogen (r = 0.29, p < 0.025), respectively. After stratification by parity, in both groups the correlations of normalization time with renal data were observed only among multiparous women, whereas in preeclampsia the link of normalization time with the week of delivery remained highly significant in both subgroups. CONCLUSIONS The differences observed between gestational hypertension and preeclampsia suggest that distinct mechanisms or a different maternal answer to the same mechanism(s), in maintaining high blood pressure in puerperium, are present in the two groups. Normalization time might reflect the recovery time of the endothelial damage in preeclampsia.

Evaluating the risk of ovarian cancer before surgery using the ADNEX model to differentiate between benign, borderline, early and advanced stage invasive, and secondary metastatic tumours: prospective multicentre diagnostic study.

Objectives To develop a risk prediction model to preoperatively discriminate between benign, borderline, stage I invasive, stage II-IV invasive, and secondary metastatic ovarian tumours. Design Observational diagnostic study using prospectively collected clinical and ultrasound data. Setting 24 ultrasound centres in 10 countries. Participants Women with an ovarian (including para-ovarian and tubal) mass and who underwent a standardised ultrasound examination before surgery. The model was developed on 3506 patients recruited between 1999 and 2007, temporally validated on 2403 patients recruited between 2009 and 2012, and then updated on all 5909 patients. Main outcome measures Histological classification and surgical staging of the mass. Results The Assessment of Different NEoplasias in the adneXa (ADNEX) model contains three clinical and six ultrasound predictors: age, serum CA-125 level, type of centre (oncology centres v other hospitals), maximum diameter of lesion, proportion of solid tissue, more than 10 cyst locules, number of papillary projections, acoustic shadows, and ascites. The area under the receiver operating characteristic curve (AUC) for the classic discrimination between benign and malignant tumours was 0.94 (0.93 to 0.95) on temporal validation. The AUC was 0.85 for benign versus borderline, 0.92 for benign versus stage I cancer, 0.99 for benign versus stage II-IV cancer, and 0.95 for benign versus secondary metastatic. AUCs between malignant subtypes varied between 0.71 and 0.95, with an AUC of 0.75 for borderline versus stage I cancer and 0.82 for stage II-IV versus secondary metastatic. Calibration curves showed that the estimated risks were accurate. Conclusions The ADNEX model discriminates well between benign and malignant tumours and offers fair to excellent discrimination between four types of ovarian malignancy. The use of ADNEX has the potential to improve triage and management decisions and so reduce morbidity and mortality associated with adnexal pathology.