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In recent years, the Risk of Ovarian Malignancy Algorithm (ROMA) score has emerged as a useful tool in the triage of women with pelvic masses. Previously, triage of women with pelvic masses to management by either benign gynecology or gynecologic oncology was performed with an initial clinical risk assessment (ICRA) alone, involving a detailed history, exam, basic laboratory tests, and imaging. We sought to determine whether use of ROMA, which is calculated using CA125, HE4, and menopausal status for triage of women with pelvic masses, provides cost savings compared to triage based on ICRA alone. A health-economic decision model was developed to assess clinical and cost differences associated with referrals for patients presenting to their gynecologist or primary care physician with an adnexal mass. In our study, we modeled the differences of two clinical pathways that included 1) use of ICRA alone and 2) use of ROMA as a determining factor in referral to a gynecologic oncologist. Using previously reported accuracy rates and patient characteristics from a prospective, multicenter, blinded clinical trial (ClinicalTrial. gov identifier NCT00987649), we assessed triage of women with a pelvic mass using ICRA alone or ROMA and modeled the related lab testing, imaging, surgical procedures, and associated costs. Costs were estimated using current Medicare reimbursement rates. A total of 423 patients with pelvic masses were included. Total healthcare costs for patients triaged for epithelial ovarian cancer (EOC) using ICRA alone were higher than when triaged by ROMA ($2,461,301 vs $2,428,628), a cost savings of 1.3%. While lab costs increased 55% when using ROMA ($16,006 vs $24,809), all other costs decreased, including total laparoscopy ($1,931,568 vs $1,896,314, -1.8% difference), total laparotomy ($436,910 vs $430,689, -1.4% difference), and total surgery ($2,368,479 vs $2,327,003, -1.8% difference) (Table 1). Repeat surgeries resulting from false negative ICRA were also reduced when using ROMA (8 vs 3), a 64% decrease. Notably, total healthcare costs were further reduced when including patients with low malignant potential (LMP) tumors ($2,646,738 vs $2,558,834, -3.3% difference) and analysis of all cancers ($2,847,829 vs $2,728,247, -4.2% difference). A similar reduction in repeat surgeries was noted in patients with LMP tumors (19 for ICRA, 7 for ROMA, -61% difference) and in all cancers (29 for ICRA, 14 for ROMA, -53% difference). [Display omitted] Triage of women with a pelvic mass using the more sensitive ROMA score compared to ICRA alone lowers overall healthcare costs. With fewer false negatives than ICRA alone, the ROMA score improves initial detection of malignancy and reduces second surgical treatments in women with pelvic masses. [ABSTRACT FROM AUTHOR]

Each year in the U.S. over two million women will be diagnosed with an ovarian cyst or pelvic mass of which approximately 200,000 will require surgery. Of these women, 22,000 (~11%) will ultimately be diagnosed with epithelial ovarian cancer (EOC). Multiple studies have demonstrated that women with EOC managed by a gynecologic oncologist and at high volume institutions for EOC have improved survival rates. Despite these facts, less than 50% of women diagnosed with EOC are cared for by gynecologic oncologists or at high volume institutions. The Risk of Ovarian Malignancy Algorithm (ROMA) was developed to assist in the triage of women at high risk for EOC to gynecologic oncologists. ROMA has been cleared by the FDA for risk assessment and triage in women presenting with an ovarian cyst or pelvic mass. The objective of this study was to demonstrate the performance of ROMA in a large population of women presenting with a pelvic mass. This is the largest collection of patients evaluated with ROMA to date. A meta-analysis was conducted by pooling data from 5 pelvic mass trials. This study was institutional review board (IRB)-exempt due to the secondary use of preexisting data. Data was combined into one cohort for analysis of ROMA. As per ROMA design, the sensitivity, PPV and NPV were calculated at a set specificity of ~75%. All samples were run on the Abbott ARCHITECT platform for both CA125 and HE4. A total of 2,004 patients were included in the analysis (837 premenopausal and 1,167 postmenopausal). There were 448 EOCs (89 stage I, 45 stage II, 284 stage III, 24 stage IV and 6 unstaged), 83 Borderline/LMP tumors, 1,224 benign masses, 23 non-epithelial ovarian cancers, 165 other gynecological cancers, 59 non-gynecologic metastatic cancers, and 2 mesotheliomas. For the detection of benign vs EOC only in pre and postmenopausal women, at a specificity of 75.0%, ROMA achieved a sensitivity of 91.3%, a PPV of 57.2% and a NPV 95.9%. In postmenopausal women, there were 554 benign cases and 379 EOCs. At a specificity of 75.3%, ROMA achieved a sensitivity of 92.3%, a PPV of 71.9% and a NPV of 93.5%. In premenopausal patients, there were 670 benign cases and 69 EOCs. At a specificity of 74.8%, ROMA achieved a sensitivity of 85.5%, a PPV of 25.9% and a NPV of 98.0%. An analysis of the ability of ROMA to differentiate early stage EOC from benign in pre and post-menopausal women revealed a sensitivity of 76.1%, a specificity of 75.0%, a PPV of 25.0% a NPV of 96.6%. ROMA detected over 98% of all late stage III and IV EOCs. ROMA has been shown in multiple independent prospective trials to be an accurate tool for pelvic mass risk assessment. This is the largest collection to date to validate the performance characteristics of ROMA. ROMA should be used as one of the tools for pelvic mass risk assessment to assist in the triage of patients at high risk for EOC to gynecologic oncologists. [ABSTRACT FROM AUTHOR]