Supplementary data: A real-world comparison of the clinical and economic utility of OVA1 and CA125 in assessing ovarian tumor malignancy risk

<b>These are peer-reviewed supplementary materials for the article '</b><b>A real-world comparison of the clinical and </b><b>economic utility of OVA1 and CA125 in </b><b>assessing ovarian tumor malignancy ris</b>k<b>' published in the</b><b> </b><b><i>Journal of Comparative Effectiveness Research</i></b><b>.</b><b>Appendix Table 1: </b>Coding<b>Aim:</b> This largest-of-its-kind study evaluated the clinical utility of CA125 and OVA1, commonly used as ovarian tumor markers for assessing the risk of malignancy. The research focused on the ability and utility of these tests to reliably predict patients at low risk for ovarian cancer. Clinical utility endpoints were 12-monthmaintenance of benign mass status, reduction in gynecologic oncologist referral, avoidable surgical intervention and associated cost savings. <b>Materials &amp; methods:</b> This was a multicenter retrospective review of data from electronic medical records and administrative claims databases. Patients receiving a CA125 or OVA1 test between October 2018 and September 2020 were identified and followed for 12 months using site-specific electronic medical records to assess tumor status and utilization outcomes. Propensity score adjustment was used to control for confounding variables. Payer allowed amounts from Merative MarketScan Research Databases were used to estimate 12-month episode-of-care costs per patient, including surgery and other interventions. <b>Results: </b>Among 290 low-risk OVA1 patients, 99.0% remained benign for 12 months compared with 97.2% of 181 low-risk CA125 patients. The OVA1 cohort exhibited 75% lower odds of surgical intervention in the overall sample of patients (Adjusted OR: 0.251, p ≤ 0.0001), and 63% lower odds of gynecologic oncologist utilization among premenopausal women (Adjusted OR: 0.37, p = 0.0390) versus CA125. OVA1 demonstrated significant savings in surgical interventions ($2486, p ≤ 0.0001) and total episode-of-care costs ($2621, p ≤ 0.0001) versus CA125. <b>Conclusion:</b> This study underscores the utility of a reliably predictive multivariate assay for assessing ovarian cancer risk. For patients assessed at low risk of ovarian tumor malignancy, OVA1 is associated with a significant reduction in avoidable surgeries and substantial cost savings per patient. OVA1 is also associated with a significant reduction in subspecialty referrals for low-risk premenopausal patients.

本文为发表于《Journal of Comparative Effectiveness Research》（《比较效果研究杂志》）的论文《评估卵巢肿瘤恶性风险的OVA1与CA125临床及经济学效用的真实世界对比》的同行评议补充材料。附录表1：编码 研究目的：本研究为同类规模最大的真实世界研究，评估了临床常用卵巢肿瘤标志物CA125与OVA1的临床效用，聚焦二者可靠识别卵巢癌低危患者的能力与实用价值。本研究的临床效用终点包括：良性病灶状态维持12个月、妇科肿瘤医师转诊率降低、可避免的外科干预及相关成本节约。材料与方法：本研究为多中心回顾性研究，数据来源于电子病历与行政索赔数据库。本研究筛选2018年10月至2020年9月期间接受CA125或OVA1检测的患者，通过各中心专属电子病历随访12个月，以评估肿瘤状态与诊疗利用结局。采用倾向得分校正法控制混杂变量。借助Merative MarketScan研究数据库的支付方核准支付金额，估算每位患者12个月诊疗周期的总成本，涵盖手术及其他干预措施的费用。结果：在290例OVA1低危患者中，99.0%的患者病灶保持良性达12个月；而181例CA125低危患者中该比例为97.2%。与CA125组相比，OVA1组在全部患者样本中接受外科干预的校正优势比为0.251，较CA125组降低75%（p≤0.0001）；在绝经前女性亚组中，OVA1组的妇科肿瘤医师转诊率校正优势比为0.37，较CA125组降低63%（p=0.0390）。相较于CA125组，OVA1组在外科干预方面可节省2486美元（p≤0.0001），总诊疗周期成本可节省2621美元（p≤0.0001）。结论：本研究证实了用于评估卵巢癌风险的可靠多变量检测方法的临床实用价值。对于被评估为卵巢肿瘤恶性风险低危的患者，OVA1可显著减少可避免的外科手术，并为每位患者带来可观的成本节约。同时，OVA1可显著降低低危绝经前患者的专科转诊率。