Characterization and comparison of pelvic mass risk assessment by gynecologists and PCPs to ROMA

Objectives: Pelvic masses can be classified as low risk (likely benign) and high risk (likely malignant) based on an initial clinical risk assessment (ICRA). The clinical assessment impacts the management and referral plan that patients receive. The objective of this study was to compare the ICRA and referral performances of primary care physicians (PCPs) and generalist gynecologists (GYNs) in the evaluation of a pelvic mass to the risk of ovarian malignancy algorithm (ROMA). Methods: Results from a prospective, multicenter trial (ClinicalTrial. gov identifier NCT00987649), evaluating women with a pelvic mass that had an ICRA performed by a non-gynecologic oncologist were used for this study. ICRA included history, physical exam, any combination of imaging (ultrasound, CT scan, MRI) and CA125 all at the physician's discretion. Types of imaging utilized in evaluation and ROMA scores were determined, and statistical parameters were calculated for the ability of ICRA and ROMA to differentiate between benign and malignant masses. Results: A total of 398 patients were included in the analysis (229 premenopausal, 169 postmenopausal), with 332 being evaluated by GYNs and 66 by PCPs. A total of 40 patients (10.1%) were diagnosed with epithelial ovarian cancer (EOC). False negative assessments for EOC comprised 5.7% and 1.4% of the subjects with a benign ICRA as determined by PCPs versus GYNs respectively (p=0.138). PCPs ICRA achieved a sensitivity of 88.2% and specificity of 67.3% compared with GYNs ICRA with a sensitivity of 82.6% and a specificity of 88.3%. The IRCA accuracy for PCPs was 72.7% versus an accuracy of 88.0% for GYNs (p=0.003). In premenopausal women the PCP ICRA achieved a sensitivity of 50.0% with a specificity of 68.2%. The GYNs ICRA sensitivity was 40.0% with a specificity of 93.0%. The accuracy for PCPs was 66.7% compared with 91.7% for GYNs (p Conclusions: GYNs more accurately use ICRA to stratify pelvic masses into benign and malignant categories, particularly in premenopausal women, and they tend to take a more cost-effective approach to initial risk assessment compared to PCPs. Use of the ROMA identifies additional EOC cases not identified by ICRA.