Faculty Bibliography

IMPORTANCE/UNASSIGNED:One-quarter of US women who are at risk for cervical cancer delay screening. Self-collected (SC) cervical screening was recently US Food and Drug Administration (FDA)-approved in the US for use in a health care setting only; an at-home SC option is crucial to address clinic-related barriers to screening. OBJECTIVE/UNASSIGNED:To clinically validate the use of an SC device that was designed for optimal at-home performance, safety, ease-of-use, and dry storage and transport. DESIGN, SETTING, AND PARTICIPANTS/UNASSIGNED:This nonrandomized clinical trial used a prospective method comparison study design. Participants aged 25 to 65 years were recruited from 16 clinical sites in the US including community and academic practices from November 20, 2023, to April 5, 2024. Data analysis was conducted from April to August 2024. INTERVENTION/UNASSIGNED:Eligible participants collected a sample with the SC method, followed by a clinician-collected (CC) sample. The SC sample was eluted into PreservCyt at the laboratory and both samples were tested on an FDA-approved high risk human papillomavirus (hrHPV) test approved for primary screening. Participants were followed up for safety and completed usability and screening preference surveys. MAIN OUTCOME AND MEASURES/UNASSIGNED:The primary outcome measures were positive percentage agreement (PPA) and negative percentage agreement for detection of hrHPV between the SC and CC samples. Other study measures included clinical sensitivity for high grade cervical dysplasia and usability. RESULTS/UNASSIGNED:Of 609 screening-eligible participants, 599 (262 aged 30-39 years [43.7%]; 583 identified as female [97.3%]) had paired SC-CC samples, of which 582 had valid paired samples included in the end point analysis. Among the 582 evaluable paired samples, the PPA between SC compared with paired CC samples for detection of hrHPV was 95.2% (95% CI, 92.1%-97.1%; 278 of 292 participants). The absolute clinical sensitivity for detection of high-grade cervical dysplasia was 95.8% (95% CI, 86.0%-98.8%; 46 of 48 participants), equivalent to the CC (relative sensitivity, 1.00). Nearly all participants (555 of 601 participants [92.3%]) reported that the device instructions were easy or very easy to understand and also that they would choose SC if they knew the results were comparable to CC results (560 of 602 participants [93.0%]). CONCLUSIONS AND RELEVANCE/UNASSIGNED:In this nonrandomized clinical trial, SC samples collected with the device showed equivalent clinical sensitivity and exceeded the PPA end point for cervical screening. This SC method was found to be easy to use and to be a preferred option with high clinical performance intended for use in an at-home setting. TRIAL REGISTRATION/UNASSIGNED:ClinicalTrials.gov Identifier: NCT06120205.

OBJECTIVES/OBJECTIVE:Women with germline BRCA1/2 pathogenic variants (gBRCA1/2) are recommended to undergo annual breast MRI and mammography. Our objective was to describe the frequency of insurance denials for annual breast MRIs in women with gBRCA1/2 and determine denial trends. METHODS:Women with gBRCA1/2 following in a high-risk breast cancer clinic with breast MRIs ordered from 2020 to 2021 were identified and cross-referenced with a database of insurance denials. Radiology records were queried to determine if screening breast MRIs were performed in 2020 and 2021. Rates of MRI denials and outcomes after appeal were determined. RESULTS:There were 682 women with gBRCA1/2 who had screening breast MRIs ordered from 2020 to 2021, including 318 (47 %) BRCA1, 356 (52 %) BRCA2, and 8 (1 %) with both. 73 women (11 %) had an MRI denied. Women insured through Medicaid had the highest rates of denials (2020: 7 %, 2021: 18 %), followed by commercial insurance (2020: 6 %, 2021: 9 %). There were significantly more denials in 2021 compared to 2020 (p = 0.044), and 2021 denials were more likely to be denied on appeal. Of women with denials, 4 (14 %) in 2020 and 5 (11 %) in 2021 did not have a screening MRI performed. One patient with DCIS had an MRI denial prior to diagnosis. CONCLUSION/CONCLUSIONS:Breast MRI insurance denials were present in 11 % of this high-risk cohort, and 14 % of women with denials did not undergo annual screening. There were significantly more denials in 2021, suggesting worsening barriers for these patients and added burden on providers to appeal for appropriate screening tests.

PURPOSE/OBJECTIVE:Cancer-related financial toxicity occurs frequently and is a key driver of inequities in access to care and disparities in treatment outcomes. Current practices to screen for financial toxicity are inconsistent because of the lack of a validated and clinically integrated screening tool. This analysis aimed to create and assess an abbreviated version of the validated Comprehensive Score for Financial Toxicity (COST) tool, a measure of financial toxicity used for research purposes, which could easily be added into often-lengthy clinical screening workflows. METHODS:At an urban comprehensive cancer center with suburban satellite locations, a financial toxicity screening quality improvement project was conducted from June 2022 to August 2023 as part of routine clinical care: 57,526 longitudinal COST surveys were completed by 38,249 patients with cancer. An iterative algorithm selected the items with highest correlation with the total score. Using a separate validation data set, positive and negative predictive values (PPV and NPV, respectively) of the abbreviated tool (two-item) were assessed against the full COST score, with varying risk thresholds. RESULTS:Inclusion of two COST questions (Q3: "I worry about the financial problems I will have in the future as a result of my illness or treatment"; Q6: "I am satisfied with my current financial situation") yielded a score that had a correlation of 0.922 with the full instrument score. For the two-item scale, PPV ranged from 74% to 91%, and NPV ranged from 91% to 98% when compared with the full COST tool. CONCLUSION/CONCLUSIONS:This analysis of a large data set finds that a simplified COST tool has high predictive value when compared with the full validated measure. An abbreviated COST measure of two questions is suitable for implementation into clinical screening workflows.

PURPOSE/OBJECTIVE:Financial toxicity (FT) is increasingly recognized as a major issue in cancer care. We evaluated the prevalence and risk factors for FT in patients with pancreatic ductal adenocarcinoma (PDAC) and FT associations with treatment adherence and quality of life (QOL). METHODS:A screening questionnaire based on the Comprehensive Score for Financial Toxicity (COST) was implemented at our National Cancer Institute-designated comprehensive cancer center. Respondents with pathologic diagnosis of PDAC who completed >50% of prompts between June 2022 and June 2023 were analyzed. COST ≤16 was categorized as FT. Associations between FT and demographic and clinical factors were assessed using logistic regression, and QOL was assessed using linear regression. RESULTS:= .049). Patients experiencing FT reported worse QOL, with a median score of 5 (IQR, 4-7) versus 8 (IQR, 6-9) without FT. This relationship persisted after adjusting for demographic and clinical factors; the effect size of FT (β = -1.5; 95% CI, -1.1 to -1.9) was nearly double that of poor performance status (β = -.8; 95% CI, -1.3 to -0.4). CONCLUSION/CONCLUSIONS:FT affected nearly one in four patients with PDAC at a high-volume cancer center and was associated with worse QOL and medication nonadherence. Universal screening and interventions to reduce FT are warranted. Clinical trials investigating QOL as an end point must account for potential confounding due to FT.

INTRODUCTION/BACKGROUND:Financial toxicity negatively affects clinical outcomes in breast cancer. Underrepresented demographics may be at higher risk for financial toxicity. We characterized disparities on the basis of age and other factors. PATIENTS AND METHODS/METHODS:Surveys completed by women with stage 0-IV breast cancer treated at Memorial Sloan Kettering Cancer Center between 06/2022 and 05/2023 were analyzed. The comprehensive score for financial toxicity (COST) scale was used to assess financial toxicity. Descriptive statistics were calculated for differences in financial toxicity/related factors, and outcomes by age and race. Associations between variables of interest and COST scores were analyzed using linear regression. RESULTS:Of 8512 respondents (75% white, 9.3% Asian, 8.4% Black), most (68%) had clinical stage 0/I disease. Stratified by age, young Black women had higher financial toxicity than young white or Asian women (p < 0.001). On multivariable analysis, women age < 45 years experienced higher financial toxicity than older women (coefficient - 2.0, 95% CI - 2.8 to - 1.1, p < 0.001). Compared with white women, financial toxicity was greater among Black (coefficient - 6.8, 95% CI - 7.8 to - 5.8) and Asian women (coefficient - 3.5, 95% CI - 4.4 to - 2.5). Cost-related medication non-adherence was more frequent among Black and Asian women (p < 0.001). Asian women more often paid for treatment with savings than white and Black women (p < 0.001). Young women reported using savings for treatment-related costs more than older (45% vs. 32%); p < 0.001). CONCLUSIONS:Racial minorities and young patients are disproportionately affected by financial toxicity. Further studies are planned to determine how financial toxicity evolves over time and whether referral to financial services effectively reduces toxicity.

OBJECTIVE/UNASSIGNED:There is a research gap on the impact of payment, reimbursement, and academic productivity in career decision-making for early-career (EC) attendings in gynecologic oncology. We sought to assess gynecologic oncology fellows and EC attendings on their knowledge and perceptions regarding the business of medicine. METHODS/UNASSIGNED:An anonymous survey was electronically disseminated to fellow and EC SGO members. Key themes were the business of medicine, productivity, and compensation/negotiation. A 5-point Likert scale was utilized; descriptive statistics were calculated using SPSS. RESULTS/UNASSIGNED:There was a 29 % response rate: 82 fellows and 102 EC attendings. Most were white (n = 143, 78 %) and female (n = 138, 75 %.) Most fellows (n = 67, 82 %) were interested in, and most EC (n = 82, 82 %) were employed in, academic/non-private practice. Fellows and EC attendings reported insufficient education on RVUs (relative value units) and reimbursement (80 %, n = 66; 81 %, n = 83) and did not feel prepared for the business aspect of practice (80 %, n = 66; 73 %, n = 75). Over 40 % of fellows did not understand how RVUs relate to practice. Thirty-three percent of EC attendings did not understand RVU assignments; 29 % were satisfied with methods used to determine productivity, and 17 % did not understand their compensation. Over 60 % of fellows felt unprepared to negotiate clinical productivity expectations. For EC attendings, 47 % were uncomfortable negotiating clinical expectations, 32 % negotiating academic expectations, and 52 % negotiating compensation changes. Female EC felt less prepared than male EC regarding the business of medicine (p = 0.02), RVU assignments (p < 0.01), and compensation negotiations (p < 0.01). CONCLUSION/UNASSIGNED:Most gynecologic oncology fellows and early-career attendings do not feel prepared for the business of medicine. Women were less comfortable with these concepts than men. Formal education should be incorporated into career development curricula.

INTRODUCTION/BACKGROUND:Financial toxicity is common among patients with cancer, as are co-occurring health-related social risks (HRSRs). There is limited evidence to support best practices in screening for HRSRs and financial toxicity in the cancer context. This analysis sought to understand variations of identified needs based on treatment course using data from a large screening program. METHODS:This 2022 to 2023 screening quality improvement program included four services (breast, gastrointestinal, gynecologic, thoracic) at an urban comprehensive cancer center. The Comprehensive Score for Financial Toxicity measured financial toxicity. Patients completed an HRSR checklist documenting food, housing, medication, or transportation insecurity and financial borrowing practices. Differences were evaluated by treatment course (radiation therapy [RT] versus other treatment and RT plus chemotherapy versus other treatment). RESULTS:Screening surveys were sent to 70,983 unique patients; 38,249 completed a screening survey (54% response rate). Of responders, 4% (n = 1,686) underwent RT in the 120 days before their survey, and 3% (n = 1,033) received RT in combination with chemotherapy. Overall, patients receiving RT had lower unadjusted Comprehensive Score for Financial Toxicity scores, indicating worse financial toxicity. The proportion of patients receiving RT reporting unmet transportation (15% versus 12%, P < .001) and food (13% versus 11%, P = .02) needs was significantly higher than for patients not receiving RT. More patients receiving RT borrowed money than did patients not receiving RT (17% versus 15%, P = .02). In multivariable models, RT (alone or in combination) was associated with worse financial toxicity and transportation difficulties. CONCLUSIONS:Screening for financial toxicity and HRSR is possible at a large cancer center. Patients receiving RT have higher transportation insecurity and worse financial toxicity compared with those receiving other treatments. Tailored intervention throughout the treatment trajectory is essential.

RATIONALE AND OBJECTIVES:This study aimed to evaluate whether implementing structured reporting based on Ovarian-Adnexal Reporting and Data System (O-RADS) magnetic resonance imaging (MRI) in women with sonographically indeterminate adnexal masses improves communication between radiologists, referrers, and patients/caregivers and enhances diagnostic performance for determining adnexal malignancy. MATERIALS AND METHODS:We retrospectively analyzed prospectively issued MRI reports in 2019-2022 performed for characterizing adnexal masses before and after implementing O-RADS MRI; 56 patients/caregivers and nine gynecologic oncologists ("referrers") were surveyed about report interpretability/clarity/satisfaction; responses for pre- and post-implementation reports were compared using Fisher's exact and Chi-squared tests. Diagnostic performance was assessed using receiver operating characteristic curves. RESULTS:A total of 123 reports from before and 119 reports from after O-RADS MRI implementation were included. Survey response rates were 35.7% (20/56) for patients/caregivers and 66.7% (6/9) for referrers. For patients/caregivers, O-RADS MRI reports were clearer (p < 0.001) and more satisfactory (p < 0.001) than unstructured reports, but interpretability did not differ significantly (p = 0.14), as 28.0% (28/100) of postimplementation and 38.0% (38/100) of preimplementation reports were considered difficult to interpret. For referrers, O-RADS MRI reports were clearer, more satisfactory, and easier to interpret (p < 0.001); only 1.3% (1/77) were considered difficult to interpret. For differentiating benign from malignant adnexal lesions, O-RADS MRI showed area under the curve of 0.92 (95% confidence interval [CI], 0.85-0.99), sensitivity of 0.81 (95% CI, 0.58-0.95), and specificity of 0.91 (95% CI, 0.83-0.96). Diagnostic performance of reports before implementation could not be calculated due to many different phrases used to describe the likelihood of malignancy. CONCLUSION:Implementing standardized structured reporting using O-RADS MRI for characterizing adnexal masses improved clarity and satisfaction for patients/caregivers and referrers. Interpretability improved for referrers but remained limited for patients/caregivers.