Faculty Bibliography

BACKGROUND:Reducing blood loss at the time of scheduled cesarean improves maternal outcomes. Type of suture material and closure technique may contribute to reduction in blood loss specifically related to the incision site as well as more expeditiously achieve uterine contractility. Prior publications have noted reduced closure times when using knotless barbed suture, but available evidence remains limited. OBJECTIVE:To examine whether patients whose hysterotomies were closed with Stratafix barbed suture at the time of scheduled cesarean delivery had lower quantified blood loss compared to patients who received Vicryl (Polyglactin 910) suture. STUDY DESIGN/METHODS:This was a prospective randomized clinical trial at a single tertiary care center in New York City. Patients with a scheduled primary or repeat cesarean delivery ≥37.0 weeks' gestation provided informed consent and were randomized to either Stratafix barbed suture or Vicryl (Polyglactin 910) suture for hysterotomy closure. The primary outcome was quantified blood loss, measured in milliliters using the mobile Stryker Triton artificial intelligence scanner. Secondary outcomes included (1) single-layer hysterotomy closure time, (2) use of additional hemostatic sutures, (3) intraoperative use of hemostatic agents, (4) rate of surgical site infection (including endometritis), and (5) differences in average postoperative pain. The Mann-Whitney U test compared observed medians of continuous outcomes between groups. Chi-squared tests compared proportional differences in categorical outcomes between groups. An a posteriori multivariable quantile regression model examined whether continuous outcomes differed when controlling for suspected confounders. RESULTS:Between July 20, 2021 and November 30, 2023, 226 patients were randomized to either Stratafix barbed suture (n=113) or Vicryl (Polyglactin 910) suture (n=113) at the time of scheduled cesarean delivery. We observed no significant difference between the median quantified blood loss observed in the Stratafix barbed suture group (544.5 [250.7-838.8] mL) and the Vicryl (Polyglactin 910) suture group (600 [348-852] mL; P=.22). Median time to hysterotomy closure was 1.3 minutes shorter in the Stratafix barbed suture group (4.1[2.6-5.6] minutes) and the Vicryl (Polyglactin 910) suture group (5.4 [3.5-7.2] minutes; P<.001). In an a posteriori multivariable quantile regression adjusting for confounders, the median total quantified blood loss was not statistically significantly different between groups (P=.37). Median time to hysterotomy closure was 1.8 minutes shorter for the Stratafix barbed suture group (P<.01). CONCLUSION/CONCLUSIONS:The use of Stratafix barbed sutures was not associated with a reduction in blood loss compared with the Vicryl (Polyglactin 910) suture. However, the results of this randomized clinical trial suggest that Stratafix barbed suture may be associated with faster single-layer hysterotomy closure time. This suggests that Stratafix barbed suture could have benefits over Vicryl (Polyglactin 910) suture for the single-layer closure of hysterotomy during cesarean delivery. Any possible benefits of using Stratafix barbed suture at the time of hysterotomy closure during scheduled cesarean require further exploration.

INTRODUCTION/BACKGROUND:Diabetes is increasingly prevalent in reproductive-aged women, but the association between social determinants of health (SDOH) and access to A1C monitoring after diagnosis are poorly understood. We explored SDOH and receipt of recommended follow-up A1C testing among postpartum women with diabetes. RESEARCH DESIGN AND METHODS/METHODS:A retrospective, population-based cohort of 5,590 women who delivered in New York City between 2009-2016 and experienced postpartum-onset diabetes. We explored associations between SDOH (race-ethnicity, nativity, insurance, nutrition program enrollment, education, and parity) and time to first follow-up test/rate of A1C testing using Cox proportional hazards and Poisson regression, respectively. We constructed models that were unadjusted, mutually adjusted, and further adjusted for clinical characteristics (body mass index, gestational diabetes mellitus, and age). RESULTS:Few women received all biannual recommended follow-up tests over the study period (13.0%). Non-Hispanic Black women were more likely to receive their first follow-up test later (adjusted HR (aHR): 0.90, 95% CI 0.80 to 1.00) and had a lower rate of testing over 3 years (adjusted rate ratio (aRR): 0.92, 95% CI 0.84 to 0.99) compared with non-Hispanic White women. Women insured by Medicaid at delivery experienced a higher hazard of an earlier first follow-up A1C test (aHR: 1.14, 95% CI 1.06 to 1.22) and higher rates of testing (aRR: 1.09, 95% CI 1.03 to 1.15) than those with private or other insurance. Women with more children experienced lower rates of testing and a longer time to first A1C test compared with those with no prior children. CONCLUSIONS:Few women with postpartum-onset diabetes met A1C monitoring guidelines, suggesting a need to improve routine diabetes monitoring, particularly among Black women. The finding of an advantage in testing among people insured by Medicaid is promising. Additional research should explore mechanisms through which Medicaid insurance and other structural interventions may improve access to and engagement in routine diabetes care.

INTRODUCTION/UNASSIGNED:To develop and validate a single-nucleotide polymorphism (SNP)-based noninvasive prenatal cell-free DNA (cfDNA) screening algorithm capable of identifying the cfDNA signal of the living fetus in vanishing twin (VT) pregnancies and assessing that twin's aneuploidy risk. METHODS/UNASSIGNED:Prospective study enrolling participants ≥18 years old at ≥9 weeks' gestation with an ultrasound-confirmed VT at 21 US sites (August 2021 to August 2023). The study protocol specified SNP-based cfDNA screening at enrollment and at two additional 3-week intervals. Neonatal buccal swabs evaluated the SNP profile of the living fetus. Cases lost to follow-up and with missing samples were excluded. Using SNP-based technology, an algorithm to identify the living fetus was developed based on the number of fetoplacental cfDNA signals and individual fetal fraction measurements. Concordance between cfDNA in maternal plasma and newborn buccal-swab SNP profiles was used to validate the algorithm in correctly identifying the living fetus. Common aneuploidies and fetal sex were determined for the living fetus. RESULTS/UNASSIGNED:Of 136 participants enrolled, 106 met criteria for the final analysis; 45 for development and 61 for validation. In the validation cohort, median gestational age was 10.7 weeks (range: 8.0-16.1 weeks) at ultrasound diagnosis of a VT. In 93.4% of validation cases, the algorithm identified the living fetus and gave an aneuploidy result; 90.2% within the first two blood draws. At the time the living fetus was identified, 39 samples had two fetoplacental signals and 18 had one. Aneuploidy results included 56 low-risk and one high-risk result for trisomy 21. Neonatal buccal swabs confirmed that the VT algorithm correctly identified the living twin and gave a correct aneuploidy result in 57/57 cases (100%; 95% confidence interval [CI]: 93.5%, 100.0%). Among 29 participants with all three blood draws and two fetoplacental signals at enrollment, two signals persisted in 93.1% at the second blood draw and 72.4% at the third. CONCLUSIONS/UNASSIGNED:The SNP-based algorithm accurately identified the living fetus in VT pregnancies in this small study. Aneuploidy risk assessment was validated in all cases where the cfDNA signal for the living twin was identified, though these findings should be interpreted with caution given the limited sample size. TRIAL REGISTRATION/UNASSIGNED:ClinicalTrials.gov Identifier: NCT05004337.

Early and reliable screening for oropharyngeal dysphagia symptoms in at-risk populations is a crucial first stage in effective management. This study aims to propose a machine learning model that can predict whether individuals are at risk of having confirmed dysphagia based on diagnostic accuracy. This was an exploratory cross-sectional diagnostic accuracy study. Adults and older adults were screened and assessed, and a videofluoroscopy swallowing study was performed to confirm dysphagia in participants with complaints about swallowing and signs or symptoms identified in the clinical assessment by a speech therapist. Eight algorithms were tested based on a theoretical model to evaluate their diagnostic accuracy: Naive Bayes, K-Nearest Neighbors, Logistic Regression, Decision Tree, Random Forest, Support Vector Machine, Multilayer Perceptron, and Convolutional Neural Networks. The Pandas library in Python was used for data visualization and manipulation. In total, 465 participants were included, of whom 153 had dysphagia. A screening with 15 items related to personal, health, and oral health characteristics is proposed. The final four best-performing models were Naive Bayes (accuracy 0.76, sensitivity 0.84), Logistic Regression (accuracy 0.79, sensitivity 0.82), Support Vector Machine (accuracy 0.78, sensitivity 0.79), and Convolutional Neural Network (accuracy 0.78, sensitivity 0.74). The use of artificial intelligence based on different machine-learning approaches is promising for dysphagia screening, demonstrating adequate diagnostic accuracy. Future studies should be conducted to externally validate the proposed screening models.

Objective To evaluate whether structured multidisciplinary team huddles with standardized indication documentation before unscheduled Cesarean delivery (CD) were associated with changes in nulliparous, term, singleton, vertex (NTSV) CD rates. Study Design This retrospective cohort study included 2,051 NTSV deliveries from a single faculty practice at a large urban academic medical center from September 1, 2023, to June 30, 2025. A structured team huddle intervention requiring a standardized paper form before unscheduled, nonelective CD was implemented October 1, 2024. Patients were categorized into preintervention (N = 1,160), transition (N = 46), intervention (N = 606), and postintervention (N = 239) periods by delivery date. The primary outcome was NTSV CD rate by period. Secondary outcomes included CD indication, labor and delivery characteristics, maternal and neonatal outcomes, and compliance. Categorical variables were compared using chi-square tests, and continuous variables were compared using independent-samples t tests or analysis of variance. Results CD rates differed significantly across the preintervention, intervention, and postintervention periods (34.9% [405/1,160], 28.9% [175/606], and 32.6% [78/239], respectively; P = .037). The odds of CD were lower during the intervention period versus preintervention (odds ratio 0.76, 95% confidence interval 0.61-0.94). Among 228 eligible unscheduled, nonelective CDs, form completion differed significantly by period (33.3% [5/15] transition, 42.6% [63/148] intervention, 0% [0/65] postintervention; P < .001). Maternal and neonatal outcomes were similar across periods. Among completed forms, partial or no agreement between form- and chart-documented indications occurred in 36.8% (25/68). Conclusion A structured multidisciplinary team huddle before CD was associated with reduced CD rates without adverse maternal or neonatal outcomes. The effect was not sustained after discontinuation of the intervention. These findings suggest real-time, team-based clinical decision support may be an effective, low-cost strategy to reduce potentially avoidable CDs.

In 2024, the International Anal Neoplasia Society (IANS) published the first consensus guidelines for anal cancer screening, outlining recommendations for patients who are most impacted by anal cancer. This study assesses provider knowledge and practice of these guidelines. A 37-item cross-sectional survey was distributed electronically to physicians, nurse practitioners, and physician assistants across ten specialties within a single health system. The survey assessed familiarity with anal cytology, guideline knowledge, screening practices, and barriers to screening. Descriptive statistics and bivariate analyses compared primary care providers (PCPs) to subspecialists. 87 providers completed the survey (62% physicians, 21% nurse practitioners, 17% physician assistants); 60% were Primary Care Physicians (PCPs) and 40% subspecialists. 55% had never heard of the IANS guidelines, and 76% had never performed an anal Pap test. Among the 70 providers completing the knowledge assessment, the median score was 10/20 (Inter Quartile Range (IQR) 8-12). Providers performed worst when identifying screening recommendations for solid organ transplant recipients (7% correct) and cisgender women with HIV (13% correct). No significant differences were found between PCPs and subspecialists across any measure. Qualitative responses identified scope of practice uncertainty (78%), lack of training (20%), and limited access to high-resolution anoscopy (9%) as primary barriers. Provider knowledge and utilization of anal cancer screening guidelines remain critically low across specialties. These findings highlight the urgent need for institution-wide education, standardized ordering pathways, and clear referral processes to improve screening rates.

OBJECTIVE:To explore factors affecting women undergoing menopause transition, focusing on lifestyle, facial-skin changes, and current aesthetic treatment interests for this. METHODS:Quantitative research (online questionnaire) was undertaken by women aged 45 to 60 years from 9 countries to understand their menopause experiences, determine their level of knowledge and perceptions of menopause, and to gain further insights into their current skin care, as well as understand menopause-related skin changes and skin concerns. RESULTS:Across 4,303 respondents, perimenopause and menopause affected facial wrinkles/fine lines (59%), loss of firmness/elasticity (58%), increased dryness (56%), and duller skin tone (40%), which negatively impacted perceived attractiveness (60% agreed/strongly agreed), creating anxiety or low mood (57% agreed/strongly agreed) and impacting self-confidence (55%). The most common treatments to reduce effects of perimenopause and menopause were food supplements (51%), everyday skincare (47%), and dietary changes (46%). Only 15% of the women used specialist aesthetic treatments for menopause, but 88% of them were satisfied/very satisfied with these treatments reducing the effects of menopause. The main triggers that encouraged the respondents to seek aesthetic treatments were health care professionals' (HCPs) recommendation (46%), cost-related affordability (40%), and information/education (40%). CONCLUSION/CONCLUSIONS:This international survey demonstrated that changes to facial skin during perimenopause and menopause negatively affect perceived facial attractiveness, creating anxiety and reducing self-confidence. Specialist aesthetic treatments might play a key role in reducing the effects of menopause on the skin, with health care professionals aiding understanding.

PURPOSE/OBJECTIVE:This work reports on the proof-of-concept testing for a suite of educational modules designed to improve oncology clinician sexual health (SH) communication with adolescent and young adult (AYA) patients. METHODS:Pediatric oncology clinicians completed four interactive SH education modules. Intervention feasibility was evaluated through rates of intervention completion and study retention, with benchmarks of 60% and 70%, respectively. Acceptability and perceived usefulness were assessed through standardized self-report measures, using a benchmark of 70% of participants rating the intervention favorably. Pre- and postsurveys evaluated knowledge, attitudes and beliefs, SH communication practices, and perceived self-efficacy. Open-ended feedback and key takeaways from each module were analyzed qualitatively. RESULTS:A total of 45 clinicians enrolled, with 39 completing the intervention and study surveys. Completion and retention rates (86.6% and 100%, respectively) exceeded the preset feasibility benchmarks. Positive endorsement of self-report measures demonstrated acceptability (100%) and perceived usefulness (94.9%). Pre- and postintervention surveys signaled increases in clinician knowledge, beliefs, and self-efficacy. Key qualitative insights from participants were received pertaining to AYA concerns, needs, and preferences and clinician responsibilities. CONCLUSION/CONCLUSIONS:This innovative approach to clinician education on SH demonstrates potential to improve clinician knowledge and engagement in SH conversations with AYAs, a key first step in improving AYA SH during and after cancer. Next steps must focus on a larger trial to assess intervention effectiveness.

BACKGROUND:Therapeutic options for patients with endometrial cancer who progress after platinum-based chemotherapy and immunotherapy are scarce, and prognosis is poor. Sacituzumab tirumotecan (sac-TMT) is a trophoblast cell-surface antigen 2-directed antibody-drug conjugate with a unique, bifunctional linker that maximises delivery of a belotecan-derived topoisomerase I inhibitor payload to tumour cells. This study aimed to compare sac-TMT with the treatment of physician's choice (TPC) in patients with endometrial cancer who had been previously treated with platinum-based chemotherapy and immunotherapy. METHODS:on days 1, 8, and 15 of each 28-day cycle). Investigators and patients were not masked to treatment; radiologists performing blinded independent central review were fully masked. Randomisation was stratified by mismatch repair status (deficient vs proficient), trophoblast cell-surface antigen 2 expression by immunohistochemistry (TROP2 EPR20043 Formulation Locked Assay [Roche Tissue Diagnostics, Tucson, AZ, USA]; low [0% to <50% of tumour cells with moderate (2+) or strong (3+) membrane staining intensity] vs medium-high [≥50% tumour cells with moderate (2+) or strong (3+) membrane staining intensity]), number of previous lines of systemic therapy (≤2 vs 3), and baseline disease status per Response Evaluation Criteria in Solid Tumors (version 1.1) by blinded independent central review (measurable vs non-measurable). Dual primary endpoints were progression-free survival per Response Evaluation Criteria in Solid Tumors (version 1.1) assessed by blinded independent central review and overall survival, analysed in the intention-to-treat population. The data cutoff date was March 23, 2026. Progression-free survival and overall survival were evaluated as dual primary endpoints using a graphical multiple-testing approach with prespecified alpha allocation. Progression-free survival was assessed every 8 weeks through to week 56, then every 12 weeks thereafter; overall survival was assessed continuously. The safety analysis included all randomly assigned patients who received at least one dose of study treatment. For progression-free survival, missing radiographic assessments were handled using prespecified censoring rules; no imputation was performed for missing overall survival or safety data. The trial was registered on ClinicalTrials.gov (NCT06132958) and is ongoing. FINDINGS/RESULTS:Between Jan 5, 2024, and Sept 17, 2025, 776 patients were randomly assigned to sac-TMT (n=386) or TPC (n=390). 384 (99%) of 386 patients in the sac-TMT group and 367 (94%) of 390 in the TPC group received at least one dose of study treatment. At data cutoff, median follow-up was 14·0 months (IQR 11·0-16·9). Median progression-free survival was 7·2 months (95% CI 5·6-7·6) in the sac-TMT group and 3·9 months (3·7-5·3) in the TPC group (hazard ratio 0·59 [95% CI 0·50-0·70]; p<0·0001) and median overall survival was 19·0 months (16·1-not reached) in the sac-TMT group and 12·1 months (11·0-15·2) in the TPC group (0·68 [0·55-0·84]; p=0·0001). 265 (69%) of 384 patients in the sac-TMT group and 210 (57%) of 367 in the TPC group had a grade 3 or higher adverse event. Serious adverse events were reported in 133 (35%) patients in the sac-TMT group and 117 (32%) patients in the TPC group. Treatment-related adverse events led to death in three (<1%) patients in the sac-TMT group and three (<1%) in the TPC group. INTERPRETATION/CONCLUSIONS:Sac-TMT significantly improved progression-free survival and overall survival versus TPC in patients with advanced or recurrent endometrial cancer previously treated with platinum-based chemotherapy and immunotherapy. These findings support sac-TMT as a new standard of care for patients with endometrial cancer who have received chemotherapy and immunotherapy and have few effective treatment options. FUNDING/BACKGROUND:Merck Sharp & Dohme.

BACKGROUND/UNASSIGNED:Treatment options for refractory gastric cancer are limited. Preclinical data suggest interplay between angiogenesis and immune regulation, with vascular endothelial growth factor impairing antitumor immunity through decreasing antigen presentation, effector function, and immune cell trafficking. This phase II study evaluated lenvatinib plus pembrolizumab in the refractory setting. PATIENTS AND METHODS/UNASSIGNED:Eligible patients had advanced gastric or gastroesophageal junction adenocarcinoma with measurable disease, Eastern Cooperative Oncology Group ≤ 1, and progression after ≥1 prior therapy, without prior immune checkpoint inhibitor exposure. Patients received pembrolizumab 200 mg i.v. every 21 days and lenvatinib 20 mg orally daily, with a 7-day lead-in. Primary endpoint was objective response rate. Using Simon optimal two-stage design, 29 patients were planned; the study would be considered positive if ≥6 responses were observed. Secondary endpoints included safety, progression-free survival (PFS), and overall survival (OS). RESULTS/UNASSIGNED:Enrollment was prematurely suspended at 24 patients due to evolving practice patterns. Median age was 63 years; 75% were male; 63% were White. Seven patients (29%) received ≥2 lines of therapy. Among 20 assessable patients, 5 (25%) achieved partial responses, including 2 with combined positive score (CPS) <1 tumors. Median duration of response was 31.6 weeks. Median PFS and OS were 12.9 and 21.4 weeks, respectively. Treatment was well tolerated with no new safety signals. CONCLUSIONS/UNASSIGNED:Lenvatinib plus pembrolizumab did not meet the predefined efficacy threshold in the overall cohort. However, treatment was well tolerated and encouraging responses were seen in patients with CPS <1 tumors. Although the sample size was limited, these findings suggest that further investigation of this treatment strategy in patients with CPS < 1 disease may be warranted.