Dedicated financial hardship screening adds value to routine distress screening among gynecologic cancer patients.

OBJECTIVES: To evaluate existing distress screening to identify patients with financial hardship (FH) compared to dedicated FH screening and assess patient attitudes toward FH screening. METHODS: We screened gynecologic cancer patients starting a new line of therapy. Existing screening included: (1) Moderate/severe distress defined as Distress Thermometer score ≥ 4, (2) practical concerns identified from Problem Checklist, and (3) a single question assessing trouble paying for medications. FH screening included: (1) Comprehensive Score for Financial Toxicity (COST) tool and (2) 10-item Financial Needs Checklist to guide referrals. FH was defined as COST score < 26. We calculated sensitivity (patients with moderate/severe distress + FH over total patients with FH) and specificity (patients with no/mild distress + no FH over total patients with no FH) to assess the extent distress screening could capture FH. Surveys and exit interviews assessed patient perspectives toward screening. RESULTS: Of 364 patients screened for distress, average age was 62 years, 25% were Black, 45% were Medicare beneficiaries, 32% had moderate/severe distress, 15% reported ≥1 practical concern, and 0 reported trouble paying for medications. Most (n = 357, 98%) patients also completed FH screening: of them, 24% screened positive for FH, 32% reported ≥1 financial need. Distress screening had 57% sensitivity and 77% specificity for FH. Based on 79 surveys and 43 exit interviews, FH screening was acceptable with feedback to improve the timing and setting of screening. CONCLUSIONS: Dedicated FH screening was feasible and acceptable, but sensitivity was low. Importantly, 40% of women with FH would not have been identified with distress screening alone.

Enduring Consensus Guidelines for Cervical Cancer Screening and Management: Introduction to the Scope and Process.

OBJECTIVES: The Enduring Consensus Cervical Cancer Screening and Management Guidelines (Enduring Guidelines) effort is a standing committee to continuously evaluate new technologies and approaches to cervical cancer screening, management, and surveillance. METHODS AND RESULTS: The Enduring Guidelines process will selectively incorporate new technologies and approaches with adequate supportive data to more effectively improve cancer prevention for high-risk individuals and decrease unnecessary procedures in low-risk individuals. This manuscript describes the structure, process, and methods of the Enduring Guidelines effort. Using systematic literature reviews and primary data sources, risk of precancer will be estimated and recommendations will be made based on risk estimates in the context of established risk-based clinical action thresholds. The Enduring Guidelines process will consider health equity and health disparities by assuring inclusion of diverse populations in the evidence review and risk assessment and by developing recommendations that provide a choice of well-validated strategies that can be adapted to different settings. CONCLUSIONS: The Enduring Guidelines process will allow updating existing cervical cancer screening and management guidelines rapidly when new technologies are approved or new scientific evidence becomes available.

Recommendations for Use of p16/Ki67 Dual Stain for Management of Individuals Testing Positive for Human Papillomavirus.

OBJECTIVES: The Enduring Consensus Cervical Cancer Screening and Management Guidelines Committee developed recommendations for dual stain (DS) testing with CINtec PLUS Cytology for use of DS to triage high-risk human papillomavirus (HPV)-positive results. METHODS: Risks of cervical intraepithelial neoplasia grade 3 or worse were calculated according to DS results among individuals testing HPV-positive using data from the Kaiser Permanente Northern California cohort and the STudying Risk to Improve DisparitiES study in Mississippi. Management recommendations were based on clinical action thresholds developed for the 2019 American Society for Colposcopy and Cervical Pathology Risk-Based Management Consensus Guidelines. Resource usage metrics were calculated to support decision-making. Risk estimates in relation to clinical action thresholds were reviewed and used as the basis for draft recommendations. After an open comment period, recommendations were finalized and ratified through a vote by the Consensus Stakeholder Group. RESULTS: For triage of positive HPV results from screening with primary HPV testing (with or without genotyping) or with cytology cotesting, colposcopy is recommended for individuals testing DS-positive. One-year follow-up with HPV-based testing is recommended for individuals testing DS-negative, except for HPV16- and HPV18-positive results, or high-grade cytology in cotesting, where immediate colposcopy referral is recommended. Risk estimates were similar between the Kaiser Permanente Northern California and STudying Risk to Improve DisparitiES populations. In general, resource usage metrics suggest that compared with cytology, DS requires fewer colposcopies and detects cervical intraepithelial neoplasia grade 3 or worse earlier. CONCLUSIONS: Dual stain testing with CINtec PLUS Cytology is acceptable for triage of HPV-positive test results. Risk estimates are portable across different populations.

An SGO commentary: U.S. News and World Report gynecologic oncology procedural ratings-Do they reflect high-quality care?

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Shifting trends and sicker patients: Reassessing hysterectomy performed for benign indications by gynecologic oncologists.

OBJECTIVE: To assess trends and differences in patient characteristics, complications, and distributions of hysterectomy for benign indications by benign gynecologists (BG) and gynecologic oncologists (GO). METHODS: This retrospective cohort study identified patients undergoing hysterectomy for benign indications using the National Surgical Quality Improvement Program data from 2014 to 2021. Exclusions were made for gynecologic or disseminated cancers, ascites, non-gynecologic surgeons, and cesarean hysterectomies. Primary outcome was major (≥Grade 3) 30-day complications, categorized into any complications, wound, cardiovascular and pulmonary, renal, infectious, andthromboembolic complications. Thirty-day readmissions, reoperations, and mortality were also analyzed. Propensity score matching was performed in a 1:1 match of GO to BG patients and was compared. Linear regressions assessed trends. RESULTS: Among 198,767 patients, 18% (n = 37,707) underwent hysterectomy for benign indications with GO. GO patients exhibited more risk factors for complications and differed significantly from BG patients in comorbidities and perioperative characteristics. Overall, GO patients had higher major complication rates (3.1% vs 2.2%, p < 0.001) and for several other composite complications. After matching, compared to BG, GO-performed hysterectomies had similar rates of major complications (3.0% vs 3.0%, p = 0.55) and no differences in other composite complications, except fewer reoperations (1.2 % vs 1.5%, p < 0.01) and wound complications (0.4% vs 0.5%, p = 0.02) in GO patients. Over the eight years, the percentage of GO-performed hysterectomy (ß = 0.41, R2 = 0.71,p < 0.01) increased significantly whereas BG-performed surgeries decreased by the same magnitude. BG had a significant decrease in frail patients (ß = -0.47, R2 = 0.90, p < 0.01), but GO did not (ß = -0.36, R2 = 0.38, p = 0.10). CONCLUSIONS: GO are performing more hysterectomies for benign indications on higher-risk patients. However, on a matched cohort, risks of major complications were similar between GO and BG.

2019 ASCCP Risk-Based Management Consensus Guidelines: Updates Through 2023.

ABSTRACT: This Research Letter summarizes all updates to the 2019 Guidelines through September 2023, including: endorsement of the 2021 Opportunistic Infections guidelines for HIV+ or immunosuppressed patients; clarification of use of human papillomavirus testing alone for patients undergoing observation for cervical intraepithelial neoplasia 2; revision of unsatisfactory cytology management; clarification that 2012 guidelines should be followed for patients aged 25 years and older screened with cytology only; management of patients for whom colposcopy was recommended but not completed; clarification that after treatment for cervical intraepithelial neoplasia 2+, 3 negative human papillomavirus tests or cotests at 6, 18, and 30 months are recommended before the patient can return to a 3-year testing interval; and clarification of postcolposcopy management of minimally abnormal results.

Adjuvant chemotherapy following chemoradiotherapy as primary treatment for locally advanced cervical cancer versus chemoradiotherapy alone (OUTBACK): an international, open-label, randomised, phase 3 trial.

BACKGROUND: Standard treatment for locally advanced cervical cancer is chemoradiotherapy, but many patients relapse and die of metastatic disease. We aimed to determine the effects on survival of adjuvant chemotherapy after chemoradiotherapy. METHODS: The OUTBACK trial was a multicentre, open-label, randomised, phase 3 trial done in 157 hospitals in Australia, China, Canada, New Zealand, Saudi Arabia, Singapore, and the USA. Eligible participants were aged 18 year or older with histologically confirmed squamous cell carcinoma, adenosquamous cell carcinoma, or adenocarcinoma of the cervix (FIGO 2008 stage IB1 disease with nodal involvement, or stage IB2, II, IIIB, or IVA disease), Eastern Cooperative Oncology Group performance status 0-2, and adequate bone marrow and organ function. Participants were randomly assigned centrally (1:1) using a minimisation approach and stratified by pelvic or common iliac nodal involvement, requirement for extended-field radiotherapy, FIGO 2008 stage, age, and site to receive standard cisplatin-based chemoradiotherapy (40 mg/m2 cisplatin intravenously once-a-week for 5 weeks, during radiotherapy with 45·0-50·4 Gy external beam radiotherapy delivered in fractions of 1·8 Gy to the whole pelvis plus brachytherapy; chemoradiotherapy only group) or standard cisplatin-based chemoradiotherapy followed by adjuvant chemotherapy with four cycles of carboplatin (area under the receiver operator curve 5) and paclitaxel (155 mg/m2) given intravenously on day 1 of a 21 day cycle (adjuvant chemotherapy group). The primary endpoint was overall survival at 5 years, analysed in the intention-to-treat population (ie, all eligible patients who were randomly assigned). Safety was assessed in all patients in the chemoradiotherapy only group who started chemoradiotherapy and all patients in the adjuvant chemotherapy group who received at least one dose of adjuvant chemotherapy. The OUTBACK trial is registered with ClinicalTrials.gov, NCT01414608, and the Australia New Zealand Clinical Trial Registry, ACTRN12610000732088. FINDINGS: Between April 15, 2011, and June 26, 2017, 926 patients were enrolled and randomly assigned to the chemoradiotherapy only group (n=461) or the adjuvant chemotherapy group (n=465), of whom 919 were eligible (456 in the chemoradiotherapy only group and 463 in the adjuvant chemotherapy group; median age 46 years [IQR 37 to 55]; 663 [72%] were White, 121 [13%] were Black or African American, 53 [6%] were Asian, 24 [3%] were Aboriginal or Pacific islander, and 57 [6%] were other races) and included in the analysis. As of data cutoff (April 12, 2021), median follow-up was 60 months (IQR 45 to 65). 5-year overall survival was 72% (95% CI 67 to 76) in the adjuvant chemotherapy group (105 deaths) and 71% (66 to 75) in the chemoradiotherapy only group (116 deaths; difference 1% [95% CI -6 to 7]; hazard ratio 0·90 [95% CI 0·70 to 1·17]; p=0·81). In the safety population, the most common clinically significant grade 3-4 adverse events were decreased neutrophils (71 [20%] in the adjuvant chemotherapy group vs 34 [8%] in the chemoradiotherapy only group), and anaemia (66 [18%] vs 34 [8%]). Serious adverse events occurred in 107 (30%) in the adjuvant chemotherapy group versus 98 (22%) in the chemoradiotherapy only group, most commonly due to infectious complications. There were no treatment-related deaths. INTERPRETATION: Adjuvant carboplatin and paclitaxel chemotherapy given after standard cisplatin-based chemoradiotherapy for unselected locally advanced cervical cancer increased short-term toxicity and did not improve overall survival; therefore, it should not be given in this setting. FUNDING: National Health and Medical Research Council and National Cancer Institute.

Doubling down on the future of gynecologic oncology: The SGO future of the profession summit report.

The original vision of the field of gynecologic oncology was to establish a multidisciplinary approach to the management of patients with gynecologic cancers. Fifty years later, scientific advances have markedly changed the overall practice of gynecologic oncology, but the profession continues to struggle to define its value-financial and otherwise. These issues were examined in full at the Society of Gynecologic Oncology (SGO) Future of the Profession Summit and the purpose of this document is to summarize the discussion, share the group's perceived strengths, weaknesses, opportunities, and threats (SWOT) for gynecologic oncologists, further educate members and others within the patient care team about the unique role of gynecologic oncologists, and plan future steps in the short- and long- term to preserve the subspecialty's critical mission of providing comprehensive, longitudinal care for people with gynecologic cancers.

Lifestyle intervention in ovarian cancer enhanced survival (LIVES) study (NRG/GOG0225): Recruitment, retention and baseline characteristics of a randomized trial of diet and physical activity in ovarian cancer survivors.

OBJECTIVE: The Lifestyle Intervention for oVarian cancer Enhanced Survival (LIVES) is a national study of a combined diet and physical activity intervention for stage II-IV ovarian cancer survival, an under-represented cancer in lifestyle behavioral intervention research. Here, we present the data on recruitment, retention, and baseline demographic, clinical and lifestyle behavior characteristics of the LIVES study participants. METHODS: The LIVES study (NRG Oncology/GOG 0225) is a Phase III diet plus physical activity intervention trial testing the hypothesis that ovarian cancer survivors in the lifestyle intervention will demonstrate better progression-free survival than those in the control condition. Study interventions were delivered via centralized telephone-based health coaching. Baseline descriptive statistics were computed for demographic, clinical, and lifestyle behavior characteristics. RESULTS: The LIVES study exceeded its recruitment goals, enrolling 1205 ovarian cancer survivors from 195 NRG/NCORP-affiliated oncology practices across 49 states from 2012 to 2018. The mean age of enrollees was 59.6 years; the majority (69.4%) with stage III disease; 89% White, 5.5% Hispanic; 64% overweight/obese. Baseline self-reported diet showed a mean daily intake of 6.6 servings of fruit and vegetables, 62.7 fat grams, and 21.7 g of fiber. Physical activity averaged 13.0 MET-hours/week of moderate to vigorous physical activity; 50.9 h/week of sedentary time. Retention rates exceeded 88%. CONCLUSION: The LIVES study demonstrates efficiency in recruiting and retaining ovarian cancer survivors in a 24-month study of diet and physical activity intervention with a primary endpoint of progression free survival that will be reported. TRIAL REGISTRATION: ClinicalTrials.govNCT00719303.

An Update on Human Papillomavirus Vaccination in the United States.

Cervical cancer remains a significant disease in the United States. Although the human papillomavirus (HPV) vaccine has been approved for those aged 9-26 years and for some individuals up to age 45 years, there are many circumstances in which health care professionals may not know whether the vaccine should be recommended, such as for patients with previous infection, health care workers, and those older than age 26 years. This article highlights the evidence that the HPV vaccine is a safe and highly effective way to prevent cervical cancer, with the strongest predictor of vaccine uptake being practitioner recommendation.

Identity-related experiences of Asian American trainees in gynecologic oncology.

Background: Anti-Asian violence increased during the COVID-19 pandemic. Asian American/Pacific Islanders (AAPI) represent a diverse population experiencing a long history of stereotyping and exclusionism; however, this group is often left out of diversity/inclusion conversations. In academic medicine, AAPI are under-represented in leadership. We characterized the personal/professional experiences of AAPI gynecologic oncology trainees and assessed the impact of a virtual panel discussion with leaders in the field. Methods: An anonymous survey was disseminated online to trainees in/interested in gynecologic oncology fellowship who identified as AAPI, using modified snowball sampling. A virtual session with AAPI leaders in gynecologic oncology discussed themes emerging from survey responses. Session attendees completed an anonymous follow-up survey. Results were assessed quantitatively and qualitatively. Results: 44/59 (75%) respondents participated in the pre-survey; 23 (39%) participated in the virtual session. All session participants (23/23, 100%) completed the post-session survey. Participants reported increased identity-related thoughts with the COVID-19 pandemic (88% during, 61% prior). Sixty-eight percent reported that identity-related thoughts/awareness changed during the pandemic. Presence of AAPI colleagues was associated with higher perceived identity-related support from their department. Of those without AAPI coworkers, none (0%) felt 'moderately' or 'extremely well supported.' Qualitative analysis demonstrated that the panel discussion created a sense of community and encouragement, combating previously reported isolation and self-consciousness. Participants reported more connection with their heritage and identified more personal/professional topics that might be related to their cultural backgrounds. Discussion: This intervention demonstrates the opportunity to provide a supportive network for mentorship and professional development in a culturally inclusive way.

Clinical outcomes in patients with COVID-19 and gynecologic cancer: A society of gynecologic oncology COVID-19 and gynecologic cancer registry study.

OBJECTIVES: Patients with gynecologic malignancies may have varied responses to COVID-19 infection. We aimed to describe clinical courses, treatment changes, and short-term clinical outcomes for gynecologic oncology patients with concurrent COVID-19 in the United States. METHODS: The Society of Gynecologic Oncology COVID-19 and Gynecologic Cancer Registry was created to capture clinical courses of gynecologic oncology patients with COVID-19. Logistic regression models were employed to evaluate factors for an association with hospitalization and death, respectively, within 30 days of COVID-19 diagnosis. RESULTS: Data were available for 348 patients across 7 institutions. At COVID-19 diagnosis, 125 patients (36%) had active malignancy. Delay (n = 88) or discontinuation (n = 10) of treatment due to COVID-19 infection occurred in 28% with those on chemotherapy (53/88) or recently receiving surgery (32/88) most frequently delayed. In addition to age, performance status, diabetes, and specific COVID symptoms, both non-White race (adjusted odds ratio (aOR) = 3.93, 95% CI 2.06-7.50) and active malignancy (aOR = 2.34, 95% CI 1.30-4.20) were associated with an increased odds of hospitalization. Eight percent of hospitalized patients (8/101) died of COVID-19 complications and 5% (17/348) of the entire cohort died within 30 days after diagnosis. CONCLUSIONS: Gynecologic oncology patients diagnosed with COVID-19 are at risk for hospitalization, delay of anti-cancer treatments, and death. One in 20 gynecologic oncology patients with COVID-19 died within 30 days after diagnosis. Racial disparities exist in patient hospitalizations for COVID-19, a surrogate of disease severity. Additional studies are needed to determine long-term outcomes and the impact of race.

Navigating job and cancer demands during treatment: A qualitative study of ovarian cancer patients.

OBJECTIVE: Our objective was to obtain perspectives from ovarian cancer patients on job demands, cancer demands, and workplace or cancer resources and strategies to manage the cancer-work interface using the cancer-work management conceptual framework. METHODS: We recruited ovarian cancer patients receiving systemic therapy who screened positive for financial distress using Comprehensive Score for Financial Toxicity <26. Interviews were conducted with participants about their costs of care, including employment concerns. Interviews were recorded, transcribed verbatim, and analyzed by three researchers using an inductive thematic analysis. RESULTS: Of 22 participants, the average age was 57 years old, 36% were Black, 68% had income <$40,000, 41% had public insurance, and 68% were being treated for recurrent disease. Job demands included decreased productivity, inability to return to work, and worry about losing a job or employer-based health insurance coverage. Cancer demands included physical and cognitive limitations due to cancer treatment and reliance on caregivers, especially for transportation. Workplace resources/strategies including having a supportive employer, modifying job responsibilities, and utilizing family medical leave. Cancer care resources/strategies included planning appointments ahead of time and utilizing resources, such as disability. CONCLUSIONS: Cancer care teams should consider screening patients for employment concerns; streamline care to minimize the side effects, time, and transportation demands of treatment on patients and caregivers; maximize utilization of available resources; and proactively communicate with employers to accommodate patients and caregivers who want or need to work.

Increased disparities associated with black women and abnormal cervical cancer screening follow-up.

Background: To determine whether race and ethnicity impacts patient adherence to follow-up for colposcopy after abnormal cervical cancer screening. Methods: This retrospective chart review included women that were randomly selected from patients presenting to our colposcopy clinic from 1/2019 to 12/2019. Inclusion criteria were females age ≥21 years-old and appropriate referral for colposcopy. Patients were grouped into three categories: (1) ADHERENT to follow-up if they came to their first scheduled appointment; (2) DELAYED if they presented more than three months from their original referral (usually missing 1-3 appointments); and (3) NOT ADHERENT if they did not show for their appointment after referral. Analysis was performed using SPSS v.26. Results: 284 women met inclusion criteria for the study. The majority of women were Black (65.2 %) followed by non-Hispanic Whites (20.0 %) and Latinx (14.8 %). Overall, 39.1 % were ADHERENT, 18.6 % were DELAYED, and 42.3 % were NOT ADHERENT. When compared with non-Hispanic White women, there was a significant difference between race/ethnicity and timing of follow-up (p = 0.03). Blacks were more likely to be NOT ADHERENT (45.9 %; p = 0.03), and Latinx and Blacks were the most likely to be DELAYED (35.7 % and 21.1 %; p = 0.03). Private insurance patients were more likely to be ADHERENT for care compared with un-/underinsured patients (78.9 vs 27.8 %, p = 0.0001). Conclusion: There is inadequate follow-up after abnormal cervical cancer screening across all races/ethnicities; however, lack of adherence is higher in Black patients. Moreover, 25% of Hispanic and Black women present in a delayed fashion. Culturally relevant assessments and interventions are needed to understand and address these gaps.

Moderate to severe distress in half of ovarian cancer patients undergoing treatment highlights a need for more proactive symptom and psychosocial management.

OBJECTIVE: Distress screening and management is a recommended component of oncology care. Our objective was to evaluate distress rate, sources, and compliance with psychosocial follow-up among ovarian cancer patients receiving chemotherapy. METHODS: We reviewed patient distress surveys completed by ovarian cancer patients receiving chemotherapy from 10/2017-6/2019. Lay or nurse navigators conducted screening with the NCCN Distress Thermometer from 0 (none) to 10 (highest distress). A distress score ≥ 4 (moderate/severe) was considered a positive screen. A recommendation for psychosocial follow-up was automatically generated in the treatment care plan based upon a yes response to any depression-related concern, independent of distress score. Documentation of referral to a mental health professional or social worker for counseling was considered compliant with psychosocial follow-up. We performed descriptive statistics and bivariate analyses. RESULTS: 97/211 (46%) ovarian cancer patients screened positive for distress. Average score was 6.1 for those who screened positive and 3.3 for the entire cohort (range 0-10). Unmarried status (p < 0.01) was associated with positive screen, whereas non-white race (p = 0.26) and recurrent disease (p = 0.21) were not. Median age was older for patients with a positive distress screen (p < 0.01). Among screened patients, the most frequent sources of distress were: cognitive/physical (87%), psychosocial (62%), practical (84%), and family concerns (40%). Of 50 patients recommended to have psychosocial referral, 4 (8%) patients had documented psychiatric follow-up and 19 (38%) patients had documented psychosocial counseling by a social worker. CONCLUSIONS: Nearly half of ovarian cancer patients screened positive for moderate/severe distress. Cancer/treatment-related cognitive/physical symptoms were the most frequent sources. Improved methods of symptom monitoring and management during treatment and resources to address psychosocial concerns are needed to improve distress management of ovarian cancer patients.

Risk-Based Cervical Consensus Guidelines: Methods to Determine Management if Less Than 5 Years of Data Are Available.

OBJECTIVES: In the 2019 ASCCP Risk-Based Management Consensus Guidelines, clinical management decisions are based on immediate and 5-year cervical intraepithelial neoplasia (CIN) 3+ risk estimates. However, data for technologies other than human papillomavirus testing and cytology may be limited to clinical trials and observational studies of shorter duration than 5 years. To enable decisions about 1- or 3-year intervals, 3-year CIN 3+ risk equivalents to 5-year CIN 3+ risk thresholds were generated. MATERIALS AND METHODS: We examined screening test result scenarios around the 5-year risk thresholds of 0.15% and 0.55% and calculated the average percent increase in CIN 3+ risk from 3 to 5 years. Using this average increase, we obtained estimates of corresponding risk thresholds at 3 years. We then validated whether use of the 3-year risk threshold would have resulted in equivalent management per the 2019 recommendations. RESULTS: Around the 5-year CIN 3+ risk threshold of 0.55%, the average increase in risk from 3 to 5 years was 0.16%. Therefore, the equivalent threshold for 3-year risk was estimated as 0.39%. We found no difference in recommendations to return in 1 or 3 years using the 3-year or 5-year risk thresholds in 66 of the 67 scenarios (98.5%) in follow-up in 2019 guidelines. CONCLUSIONS: In this methodological addendum, the Enduring Guidelines Committee adopted the use of the 0.39% 3-year CIN 3+ risk threshold as equivalent of the 0.55% 5-year CIN 3+ risk threshold for technologies with fewer than 5 years of follow-up data. This allows evidence-based guidance for surveillance intervals of 1 or 3 years for new technologies with limited longitudinal data.

Feasibility, Safety, and Provider Perspectives of Bipolar Electrosurgical Cautery Device for (Opportunistic or Complete) Salpingectomy at the Time of Cesarean Delivery.

OBJECTIVES: The aim of the study is to evaluate the use of a bipolar electrocautery device for complete salpingectomy at cesarean to improve procedure completion rates, operative time, and surgeon reported satisfaction as compared with standard bilateral tubal ligation (BTL) and suture-cut-tie salpingectomy. STUDY DESIGN: This is a prospective cohort study of women undergoing planned, non-emergent cesarean with desired sterilization with complete salpingectomy utilizing a bipolar electrocautery device. Study patients were compared with historic controls from a randomized controlled trial (RCT) of complete salpingectomy via suture-cut-tie method versus BTL conducted at our institution (SCORE trial, NCT02374827). Outcomes were compared with groups from the original RCT. RESULTS: Thirty-nine women were consecutively enrolled (12/2018-11/2019) into the device arm of the study and compared with the original SCORE cohort (n = 40 BTL, n = 40 salpingectomy without a device). Salpingectomy performance with the bipolar electrocautery device was successfully completed in 100% (39/39) of enrolled women, with one device failure requiring the use of a second device, as compared with 95% (38/40) in the BTL (p = 0.49) and 67.5% (27/40) in salpingectomies without a device (p < 0.001). Mean operative time of sterilization procedure alone demonstrated device use as having the shortest operative time of all (device salpingectomy 5.0 ± 3.6 vs. no device 18.5 ± 8.3 minutes, p < 0.001; and vs. BTL 6.9 ± 5.0, p = 0.032). Mean sterilization procedure endoscopic band ligation (EBL) was demonstrated to be significantly different between each group, least amongst BTL followed by device (6.3 ± 4.8 vs. 8.4 ± 24.8, p < 0.001), and most by suture-cut-tie method (17.7 ± 14.3, p < 0.001 compared with device). Surgeon reported attitudes of complete salpingectomy performance in general practice outside an academic setting was greater with a device than without (79.5 vs. 35.3%; p < 0.001). CONCLUSION: Use of a bipolar electrocautery device improved operative times and surgeon satisfaction for salpingectomy at cesarean over standard suture ligation. Device use improved surgeon reported outcomes and may improve incorporation of complete salpingectomy at cesarean. KEY POINTS: · Electrocautery bipolar device use was safe at the time of salpingectomy during cesarean.. · Greater surgeon satisfaction occurs using a device than without.. · Decreased surgical time with device use is seen making the procedure equal to BTL..

Human papillomavirus seroprevalence and seroconversion following baseline detection of nine human papillomavirus types in young women.

BACKGROUND: Estimates of the humoral immune response to incident human papillomavirus (HPV) infections are limited. METHODS: In this post hoc analysis of 3875 women aged 16-23 years from a 4-valent HPV vaccine trial (NCT00092482), HPV seroprevalence on day 1 was measured with a 9-valent HPV (HPV 6/11/16/18/31/33/45/52/58) competitive Luminex immunoassay and compared with cervical/external genital HPV detection by polymerase chain reaction. In the control group, among women who were HPV DNA‒negative on day 1, seroconversion following initial HPV detection was estimated using Kaplan-Meier methods. RESULTS: Type-specific HPV seropositivity among women with no day 1 cervical/external genital HPV detection was 0.6%-3.6%. Women with any 9-valent HPV (9vHPV) cervical/external genital detection (796/3875; 20.5%) had concordant seropositivity ranging from 13.4% (HPV 45) to 38.5% (HPV 6). Among women in the control group who were negative for all HPV types on day 1, seroconversion by month 30 after initial detection ranged from 29% (HPV 45) to 75% (HPV 16). CONCLUSIONS: Humoral immune response to HPV is variable and dynamic, depending on type-specific exposure. This longitudinal analysis provides insight into the relationship between incident infection and seropositivity. CLINICALTRIALS: gov; NCT00092482 https://clinicaltrials.gov/ct2/show/NCT00092482.

Piloting use of an out-of-pocket cost tracker among gynecologic cancer patients.

Objective: Our objective was to evaluate uptake and satisfaction with an out-of-pocket (OOP) cost tracker as a means for cancer patients to manage their personalized costs of care and to identify characteristics associated with usage. Methods: Within a longitudinal survey evaluating financial toxicity among gynecologic cancer patients on active systemic therapy over a 6-month period, we provided paper worksheets for participants to voluntarily track expenses. We assessed usage and satisfaction at 3 and 6 months using frequency and percentage. We used Fisher's exact test and Wilcoxon rank sum analysis to evaluate patient characteristics based upon usage. Participants were encouraged to submit their completed cost tracker worksheets. Results: Fifty-three of 121 (44%) participants reported ever using the OOP cost tracker. Most users reported it was easy to use (97%, 100%) and helpful (86%, 72%); however, fewer users rated it as useful for budgeting (42%, 26%) at 3 and 6 months, respectively. More patients who knew their insurance premium were users compared to non-users (74.4% vs. 54.4%, p = 0.04). Among thirteen users who submitted their completed cost tracker worksheets, non-medical costs (i.e., transportation) had the highest monthly out of pocket costs (mean $213, range $0-587). User feedback included suggestions to enhance the cost tracker with educational tutorials or a reminder system. Conclusions: Future studies should explore if cost tracker uptake and satisfaction are enhanced with the addition of reminders and whether usage decreases financial toxicity or increases patient self-efficacy in managing the costs of cancer care.