Cerclage plus Adjuvant Vaginal Progesterone for Preterm Birth Prevention in Patients with a Short or Dilated Cervix without Prior Preterm Birth.

OBJECTIVE: The primary objective was to determine if vaginal progesterone following cerclage for cervical length <10 mm or cervical dilation in patients without a history of spontaneous preterm birth (sPTB) decreased the risk of preterm birth at <34 weeks' gestation compared with cerclage alone. Secondary objectives were to determine if vaginal progesterone following cerclage (1) decreased the risk of preterm birth at <24, <28, and <37 weeks' gestation and (2) increased the latency period from cerclage placement to delivery compared with treatment with cerclage alone. STUDY DESIGN: Multicenter retrospective cohort study from 2015 to 2020 of singleton pregnancies, without prior sPTB, who had cerclage placement <24 weeks' gestation for cervical length <10 mm or cervical dilation. Exposure defined as cerclage plus vaginal progesterone postoperatively (dual therapy) and unexposed as cerclage alone (monotherapy), based on surgeon preference. RESULTS: We included 122 patients, 78 (64%) treated with dual therapy and 44 (36%) treated with monotherapy. In the crude analysis, dual therapy was associated with a lower risk of delivery at <28 weeks' gestation (13%) compared with monotherapy (34%; crude risk ratio: 0.38 [95% confidence interval, CI: 0.19-0.75]). When adjusted for preoperative vaginal progesterone, results were attenuated (adjusted risk ratio: 0.45 [95% CI: 0.20-1.01]). In both the crude and adjusted analyses, the risk of sPTB was not statistically different at <24, <34 or <37 weeks' gestation. Dual therapy was associated with a greater pregnancy latency from cerclage to delivery (16.3 vs. 14.4 weeks; p = 0.04), and greater gestational age at delivery (37.3 vs. 35.8 weeks' gestation; p = 0.02) compared with monotherapy. CONCLUSION: While not statistically significant, the risk of sPTB was lower at all gestational ages studied in patients treated with dual therapy compared with monotherapy. Dual therapy was associated with longer pregnancy latency and greater gestational age at delivery compared with monotherapy. KEY POINTS: · Dual therapy did not decrease preterm birth risk compared with monotherapy.. · Dual therapy prolonged pregnancy compared with monotherapy.. · Dual therapy can be considered but further studies are needed..

Clinician communication after discovery of a soft marker of aneuploidy during pregnancy: A mixed methods assessment of a communication workshop.

BACKGROUND: Soft markers of aneuploidy are common findings on obstetric ultrasounds but disclosure often increases patient anxiety. It is unknown whether communication training affects patient experience of soft marker disclosure. Our objective was to evaluate clinician experience of a simulation-based communication workshop and assess workshop influence on patient anxiety, understanding, and perception of communication quality. METHODS: We implemented a communication workshop for clinicians at an academic institution in 2019, and assessed clinician anxiety and confidence with counseling before and after. To assess effect of the workshop on patients, we surveyed pregnant people before and after workshop implementation for whom an echogenic intracardiac focus, choroid plexus cyst, or urinary tract dilation was identified. The primary outcome was anxiety. Some respondents completed a semi-structured interview. Interviews were analyzed using thematic analysis. RESULTS: Twelve clinicians participated. Twenty-one out of 49 eligible patients (43%) completed a survey before the workshop and 40 out of 90 eligible patients (44%) completed a survey after. The risk of high anxiety after was similar to before the workshop (aRR 1.7, 95% CI 0.6-4.2). Twenty patients were recruited for an interview. Qualitative analysis revealed that patients' backgrounds, emotional impact of the conversation and clinician manner influenced perception of communication quality. CONCLUSION: While a single clinician workshop did not affect patient anxiety, clinician manner and personalization play a large role in perception of counseling about soft markers of aneuploidy.

Association of body mass index with early age at diagnosis of endometrial intraepithelial neoplasia.

OBJECTIVE: Elevated body mass index (BMI) is a risk factor for endometrioid endometrial cancer and its precursor, endometrial intraepithelial neoplasia (EIN). Our objective was to describe the association between BMI and age at EIN diagnosis. METHODS: We conducted a retrospective study of patients diagnosed with EIN from 2010 to 2020 at a large academic medical center. Patient characteristics were stratified by menopausal status and compared using a chi-square or t-test. We used linear regression to determine the parameter estimate (ß) and 95% confidence interval for the association between BMI and age at diagnosis. RESULTS: We identified 513 patients with EIN; 503 (98%) had complete medical records. Premenopausal patients were more likely to be nulliparous and to have polycystic ovary syndrome than postmenopausal patients (both p ≤ 0.001). Postmenopausal patients were more likely to have hypertension, type 2 diabetes, and hyperlipidemia (all p ≤ 0.02). There was a significant linear association between BMI and age at diagnosis in premenopausal patients (ß = -0.19 (95% CI: -0.27, -0.10). In premenopausal patients, for every 1-unit increase in BMI, age at diagnosis decreased by 0.19 years. No association was observed in postmenopausal patients. CONCLUSIONS: In a large cohort of patients with EIN, increasing BMI was associated with an earlier age at diagnosis in premenopausal patients. This data suggests consideration of endometrial sampling in younger patients with known risk factors for excess estrogen exposure.

Acceptance of genetic editing and of whole genome sequencing of human embryos by patients with infertility before and after the onset of the COVID-19 pandemic.

RESEARCH QUESTION: Has acceptance of heritable genome editing (HGE) and whole genome sequencing for preimplantation genetic testing (PGT-WGS) of human embryos changed after the onset of COVID-19 among infertility patients? DESIGN: A written survey conducted between April and June 2018 and July and December 2021 among patients at a university-affiliated infertility practice. The questionnaire ascertained the acceptance of HGE for specific therapeutic or genetic 'enhancement' indications and of PGT-WGS to prevent adult disease. RESULTS: In 2021 and 2018, 172 patients and 469 patients (response rates: 90% and 91%, respectively) completed the questionnaire. In 2021, significantly more participants reported a positive attitude towards HGE, for therapeutic and enhancement indications. In 2021 compared with 2018, respondents were more likely to use HGE to have healthy children with their own gametes (85% versus 77%), to reduce disease risk for adult-onset polygenic disorders (78% versus 67%), to increase life expectancy (55% versus 40%), intelligence (34% versus 26%) and creativity (33% versus 24%). Fifteen per cent of the 2021 group reported a more positive attitude towards HGE because of COVID-19 and less than 1% a more negative attitude. In contrast, support for PGT-WGS was similar in 2021 and 2018. CONCLUSIONS: A significantly increased acceptance of HGE was observed, but not of PGT-WGS, after the onset of COVID-19. Although the pandemic may have contributed to this change, the exact reasons remain unknown and warrant further investigation. Whether increased acceptability of HGE may indicate an increase in acceptability of emerging biomedical technologies in general needs further investigation.

Characteristics of providers who prescribed only anticholinergic medications for overactive bladder in 2020.

BACKGROUND: Pharmacologic therapy for overactive bladder typically includes either an anticholinergic or a beta-3 agonist. Based on research that has demonstrated increased risks of cognitive impairment and dementia associated with anticholinergic use, current guidelines support the use of beta-3 agonists rather than anticholinergics in older patients. OBJECTIVE: This study aimed to describe the characteristics of providers prescribing only anticholinergics to treat overactive bladder in patients aged ≥65 years. STUDY DESIGN: The US Centers for Medicare and Medicaid Services publishes data on medications dispensed to Medicare beneficiaries. Data include the National Provider Identifier of the prescriber and the number of pills prescribed and dispensed for any given medication for beneficiaries aged ≥65 years. We obtained each provider's National Provider Identifier, gender, degree, and primary specialty. National Provider Identifiers were linked to an additional Medicare database that includes graduation year. We included providers who prescribed pharmacologic therapy for overactive bladder in 2020 for patients aged ≥65 years. We calculated the percentage of providers who prescribed only anticholinergics (and did not prescribe beta-3 agonists) for overactive bladder and stratified by provider characteristics. Data are reported as adjusted risk ratios. RESULTS: In 2020, 131,605 providers prescribed overactive bladder medications. Of those identified, 110,874 (84.2%) had complete demographic information available. Although only 7% of providers who prescribed medications for overactive bladder were urologists, prescriptions from urologists accounted for 29% of total prescriptions. Among providers prescribing medications for overactive bladder, 73% of female providers prescribed only anticholinergics, whereas 66% of male providers prescribed only anticholinergics (P<.001). The percentage of providers that prescribed only anticholinergics also varied by specialty (P<.001), with providers specialized in geriatric medicine being least likely to prescribe only anticholinergics (40%), followed by urologists (44%). Nurse practitioners (75%) and family medicine physicians (73%) were more likely to prescribe only anticholinergics. The percentage of providers who prescribed only anticholinergics was the highest for recent medical school graduates and decreased with time since graduation. Overall, 75% of providers within 10 years of graduation prescribed only anticholinergics, whereas only 64% of providers who were >40 years of age from graduation prescribed only anticholinergics (P<.001). CONCLUSION: This study identified considerable differences in prescribing practices based on provider characteristics. Female physicians, nurse practitioners, physicians trained in family medicine, and those who recently graduated from medical school were the most likely to prescribe only anticholinergic medications and not prescribe any beta-3 agonist for the treatment of overactive bladder. This study identified differences in prescribing practices based on provider demographics that may guide educational outreach programs.

Despite Recommendations, Anticholinergics Account for the Majority of Prescriptions to Treat Overactive Bladder in the United States.

IMPORTANCE: There are significant associations between anticholinergic medication use and an increased risk of cognitive impairment and dementia. Many experts now advocate minimizing the use of anticholinergic medications to treat overactive bladder (OAB) in elderly women. OBJECTIVE: The aim of this study was to describe temporal and geographic trends in the pharmacologic treatment of OAB for patients 65 years or older across the United States. STUDY DESIGN: The U.S. Centers for Medicare & Medicaid Services publishes annual Medicare Provider Utilization and Payment Data. The data set includes the number of unique Part D beneficiaries 65 years or older with at least 1 claim for a drug and the number of 30-day fills dispensed. The database also includes the U.S. state and rural-urban commuting area designation of the prescriber. RESULTS: From 2013 to 2019, Medicare Part D beneficiaries 65 years or older received 47.7 million 30-day fills for the treatment of OAB. In 2013, anticholinergics represented 98% of the total 30-day fills (5.6 million) for OAB. The use of ß3 agonists was nearly 24 times greater in 2019 than in 2013. Geographic variation in prescribing practices was evident. CONCLUSIONS: The number of anticholinergics dispensed for the treatment of OAB remained relatively stable, and there was a substantial increase in the use of ß3 agonists. Percentages of anticholinergics dispensed varied among states. More patients are being treated for OAB; however, anticholinergics comprised the majority of prescriptions for treatment in 2019.

Endometrial stripe thickness: a preoperative marker to identify patients with endometrial intraepithelial neoplasia who may benefit from sentinel lymph node mapping and biopsy.

OBJECTIVES: The goal of our study was to identify preoperative factors in patients with endometrial intraepithelial neoplasia that are associated with concurrent endometrial cancer to select patients who may benefit from sentinel lymph node (SLN) assessment at the time of hysterectomy. METHODS: Retrospective single institution cohort study of patients with a preoperative diagnosis of endometrial intraepithelial neoplasia who underwent hysterectomy with or without staging from January 2010 to July 2020. Modified Poisson regression was used to calculate risk ratios (RR) and 95% confidence intervals (CI). RESULTS: Of 378 patients with a preoperative diagnosis of endometrial intraepithelial neoplasia, 275 (73%) had endometrial intraepithelial neoplasia and 103 (27%) had invasive cancer on final pathology. Age (p=0.003), race (p=0.02), and hypertension (p=0.02) were significantly associated with concurrent endometrial cancer. The median preoperative endometrial stripe was significantly greater in the endometrial cancer group (14 mm (range 10-19)) than in the endometrial intraepithelial neoplasia group (11 mm (range 8-16); p=0.002). A preoperative endometrial stripe ≥20 mm was associated with double the risk of endometrial cancer on final pathology (crude RR 2.0, 95% CI 1.3 to 2.9) and preoperative endometrial stripe ≥15 mm was 2.5 times more likely to be associated with high risk Mayo criteria on final pathology (crude RR 2.5, 95% CI 1.2 to 5.2). Of those with concurrent endometrial cancer, 5% were stage IB, 29% had tumors >2 cm, and 1% had grade 3 histology. Only 3% of all patients underwent lymph node evaluation. CONCLUSIONS: In a large cohort of patients with a preoperative diagnosis of endometrial intraepithelial neoplasia, less than a third had invasive cancer and even fewer had pathologic features considered high risk for nodal metastasis, arguing against the use of routine SLN dissection in these patients. Endometrial stripe ≥15 mm may be a useful preoperative marker to identify patients at higher risk for concurrent endometrial cancer and may be an important criterion for use of selective SLN dissection in carefully selected patients with endometrial intraepithelial neoplasia.

Comparison of Trendelenburg Angles in Vaginal, Laparoscopic, and Robotic Uterovaginal Apical Prolapse Repairs.

STUDY OBJECTIVE: To compare the Trendelenburg angle used in laparoscopic uterovaginal apical prolapse repairs with the angles used in vaginal and robotic uterovaginal apical prolapse repairs. DESIGN: Prospective, multicenter cohort study from May 2015 to December 2016. SETTING: Two academic teaching hospitals. PATIENTS: Sixty patients who underwent vaginal high uterosacral ligament suspension, laparoscopic sacrocolpopexy, or robotic sacrocolpopexy performed by 6 surgeons board-certified in female pelvic medicine and reconstructive surgery. INTERVENTIONS: Measurement of Trendelenburg angle and time spent in Trendelenburg during surgery. MEASUREMENTS AND MAIN RESULTS: Twenty patients were enrolled in each procedure group. The median maximum angle of Trendelenburg was significantly greater in the laparoscopic group (22° [20-25]) than in the vaginal group (15° [6-19]; p <.001) and the robotic group (19° [16-21]; p = .02). The participants in the laparoscopic group spent significantly more time overall in Trendelenburg (176 minutes [143-221]) than those in the robotic group (150 minutes [127-161]; p = .01) and those in the vaginal group (120 minutes [86-128]; p <.001). The participants in the laparoscopic and robotic groups spent similar amounts of time in maximum Trendelenburg (116 minutes [52-164] and 117 minutes [61-134], respectively; p = .56), whereas the participants in the vaginal group spent significantly less time in maximum Trendelenburg (10 minutes [7-38]) than those in the laparoscopic group (p <.001). The total median operative time was highest for the laparoscopic approach (211 minutes [173-270]), followed by the robotic approach (181 minutes [165-201]) and the vaginal approach (162 minutes [128-186]; p = .008). CONCLUSION: The median maximum angle of Trendelenburg was highest in laparoscopic sacrocolpopexy-followed by robotic sacrocolpopexy-and lowest in vaginal high uterosacral ligament suspension. Patients who underwent robotic sacrocolpopexy spent less time in Trendelenburg than those who underwent the laparoscopic approach. Prolonged, steep Trendelenburg is often not required for any of the 3 surgical procedures, but a vaginal approach should be considered for those at high risk of complications from Trendelenburg position.

Composite Outcomes After Posterior Colporrhaphy With and Without Biologic Graft Augmentation.

OBJECTIVES: To compare subjective and objective failure after posterior colporrhaphy with and without biologic graft augmentation. METHODS: We conducted a retrospective chart review and telephone survey of patients who underwent a posterior colporrhaphy with and without biologic graft augmentation from 2005 to 2019. Patients who underwent a sacrocolpopexy, uterosacral ligament suspensions, or anterior sacrospinous ligament fixation were excluded. We determined objective, subjective, and composite failure rates. RESULTS: Although 137 patients met eligibility criteria, 56 did not have valid contact information and, therefore, were excluded from the study. Of the 81 with valid contact information, 67 (83%) agreed to participate. There were 24 (36%) who had a native tissue repair and 43 (64%) who had biologic graft augmentation. Median telephone follow-up was 73 months (interquartile range [IQR], 36-117). Objective failure was similar for the biologic graft (37%) and the native tissue (42%) groups (P = 0.72). Subjective failure was twice as likely among the biologic graft group (60%) compared with the native tissue group (33%, P = 0.03). Patients with a biologic graft reported a median Pelvic Floor Distress Inventory-Short Form 20 improvement of 31 (IQR, 8-33), while those with a native tissue repair reported a median improvement of 45 (IQR, 4-46). Overall, 78% were satisfied, 85% would recommend the procedure, and 84% reported symptomatic improvement. Reoperation occurred for 15% of patients. CONCLUSIONS: Although biologic graft-augmented posterior colporrhaphy may be a safe and effective treatment option, the use of biologic grafts in the posterior compartment does not appear to confer a significant long-term benefit to traditional posterior colporrhaphy.