Reducing Barriers for Expedited Partner Treatment in Adolescents and Young Adults: A Quality Improvement Initiative.

BACKGROUND: Adolescents and young adults (AYAs) face significant barriers to screening, testing, and treatment of sexually transmitted infections (STIs). Expedited partner therapy (EPT) streamlines partner treatment of STIs, but use among adolescents is low. We aimed to increase EPT offering and provision at 2 adolescent medicine clinics (AMCs) and the emergency department (ED) in an urban children's hospital. We addressed barriers at provider, pharmacy, and patient levels. We compared EPT offering and provision for chlamydia ( Chlamydia trachomatis [CT]) and trichomonas ( Trichomonas vaginalis [TV]) infection at baseline and across 2 intervention cycles. METHODS: Baseline data were collected from July 2019 to March 2020 and our intervention time frame spanned from April 2020 to October 2021. Laboratory codes identified patients with CT or TV infections. Cycle 1 allowed providers to order EPT within a patient's chart. The second cycle targeted education and standardization for STI/EPT notification and counseling. During this cycle, notification of ED patients was centralized to the AMC nurses. RESULTS: A total of 747 CT and TV cases were identified. In the AMC, EPT offering increased from 77.3% to 87.7% ( P = 0.01). Expedited partner therapy provision increased from 32.3% to 69.9% ( P < 0.001). Expedited partner therapy offering for ED patients increased by 82.3%. Retesting rates remained consistent, with a significant drop in reinfection rates ( P = 0.003) within patients seen in the AMC. CONCLUSIONS: This quality improvement initiative successfully increased EPT offering and provision among the cases identified. Future cycles may include longer-term follow-up to confirm partner treatment and testing per guidelines.

Family medicine physician identification of obstetric lacerations: a US national survey.

INTRODUCTION AND HYPOTHESIS: We evaluated family medicine obstetric providers' identification and categorization of vaginal delivery lacerations in the USA. We hypothesized that there would be inaccuracy in family medicine physicians' identification of vaginal delivery injuries, similar to our previous studies of midwives and obstetricians (OBs). METHODS: We included clinically active physicians who attended deliveries within 2 years and evaluated their identification and categorization of delivery lacerations using descriptive text and visual images. We asked about their education on this topic and how they document lacerations in the labor and delivery record. RESULTS: We analyzed 250 completed responses (70% of opened surveys). Fifty-five percent of respondents characterized their obstetric laceration training as "good" or "excellent" and half previously had education on obstetric lacerations. The median accuracy overall for the classification and identification of perineal lacerations was 78% (IQR 56-91%). Respondents frequently mischaracterized nonperineal lacerations. Few respondents (36%) reported using the third-degree injury subclassification system. In adjusted analysis, the highest scoring respondents were board certified in family medicine, with fewer years in practice, and a higher obstetric volume. CONCLUSIONS: Obstetric laceration diagnoses may be inaccurate, which could influence perinatal quality and patient outcomes. We found gaps in knowledge similar to previous reports on midwives and obstetricians in the USA. These data suggest a need for increased education and training on obstetric injuries, perhaps especially for physicians with less obstetric activity. Improved categorization and identification of vaginal delivery trauma can impact management and improve women's postpartum care and long-term pelvic floor outcomes.

Clinicopathologic Evaluation of CTNNB1 Mutations in High-Intermediate Risk Endometrial Endometrioid Carcinoma.

CTNNB1 mutations convey increased risk of recurrence in low-risk endometrial endometrioid carcinoma (EEC). Results from previous high-intermediate risk (HIR) cohorts are mixed. The aims of this study were to correlate CTNNB1 mutational status with clinical outcomes and to evaluate the relationship between CTNNB1 mutations and the 4 prognostic subgroups defined by The Cancer Genome Atlas in HIR EEC. CTNNB1 mutational status was determined by Sanger sequencing of exon 3 of the CTNNB1 gene. Mismatch repair, POLE , p53, and L1 cell-adhesion molecule (L1CAM) status were also evaluated. Descriptive statistics and survival analyses were performed. Eighty-eight cases of HIR EEC were identified, of which 22 (25%) were CTNNB1 mutant ( CTNNB1 -mut) and 66 (75%) were wild-type ( CTNNB1 -WT). Median follow-up was 60 mo. Recurrence occurred in 13/88 (15%) patients. Recurrence rates were not significantly different between patients with CTNNB1- mut and CTNNB1- WT tumors (14% vs. 15%, P =0.86). Recurrence-free survival and overall survival were not significantly different (recurrence-free survival hazard ratio: 0.97, 95% confidence interval: 0.27-3.52, P =0.96; overall survival hazard ratio: 0.23, 95% confidence interval: 0.03-1.71, P =0.15). Mismatch repair deficiency was more prevalent in CTNNB1 -WT compared with CTNNB1 -mut tumors (46% vs. 14%, P =0.01); prevalence of POLE mutations and aberrant p53 were not significantly different. In contrast to patients with low-risk EEC, no differences in recurrence or survival were found in patients with HIR EEC with CTNNB1- mut compared with CTNNB1 -WT tumors.

Interconception Care for Adolescent Women During the COVID-19 Pandemic.

BACKGROUND AND OBJECTIVE: Interconception care (ICC) is a means of improving health outcomes for women and children by mitigating maternal risks between pregnancies. Within a pediatric medical home ICC is reliant on adherence to well-child visits (WCVs). We hypothesized that a pediatric-based ICC model would remain successful in providing access to services for adolescent women for those seen during the COVID19 pandemic. The objective of this study was to determine if the COVID19 pandemic influenced LARC use and repeat pregnancy for those seen for ICC in a dyadic pediatric medical home. METHODS: The pre-COVID cohort was comprised of adolescent women seen for ICC from September 2018-October 2019. The COVID cohort was comprised of adolescent women seen for ICC from March 2020-March 2021. The two cohorts were compared across multiple characteristics including sociodemographic factors, age, education, number of visits, contraceptive choice and repeat pregnancy during the study interval. RESULTS: The COVID cohort were significantly more likely to be primiparous, seen with a younger infant, and attend fewer visits than the pre-COVID cohort. The COVID cohort were equally likely to initiate long-acting reversible contraception but less likely to experience a repeat pregnancy. CONCLUSIONS: The COVID19 pandemic limited access to routine healthcare and likely impacted access to ICC for many women. ICC provided during WCVs allowed access to care even amid the restrictions of the COVID19 pandemic. Both effective contraception and decreased repeat pregnancy were maintained, highlighting the effectiveness of this approach for ICC within a dyadic pediatric medical home.

Patient perspectives of telehealth for fertility care: a national survey.

PURPOSE: To evaluate patient satisfaction using telehealth for fertility care. METHODS: Cross-sectional survey using the validated telehealth usability questionnaire (TUQ) distributed nationally via fertility advocacy groups of fertility patients aged ≥ 18 years with self-reported use of telehealth for care. Patient satisfaction of telehealth for fertility care as determined by the TUQ questionnaire. The survey also included questions about telehealth related to usefulness, ease of use, effectiveness, reliability, and the option for patients to add open-ended comments related to their experiences using telehealth for fertility care. RESULTS: A total of 81 fertility patients completed the survey. Patients reported high rates of satisfaction (81.4%) with telehealth in areas of usefulness, ease of use, effectiveness, reliability, and satisfaction. However, many patients (60.5%) expressed a preference for in-person visits for their initial visit while the acceptability of telehealth increased for follow-up visits. Negative themes from respondent comments address that telehealth visits felt more impersonal and rushed. CONCLUSION: Fertility patients reported high satisfaction using telehealth for care. Patients still preferred in-person visits for initial consultations. For follow-up visits, most respondents favored telehealth or had no preference. Incorporation of telehealth in fertility practices should continue though it may be helpful for patients to be given options for visit types.

Maternal morbidity after preterm premature rupture of membranes at <24 weeks' gestation.

BACKGROUND: After preterm premature rupture of membranes at <24 weeks' gestation, pregnant women may choose continuation (expectant management) or termination of pregnancy, via either dilation and evacuation or labor induction. Neonatal outcomes after expectant management are well described. In contrast, limited research addresses maternal outcomes associated with expectant management compared to termination of pregnancy. OBJECTIVE: This study aimed to compare maternal morbidity after preterm premature rupture of membranes at <24 weeks' gestation in women who choose either expectant management or termination of pregnancy. STUDY DESIGN: This retrospective cohort study included women with preterm premature rupture of membranes between 14 0/7 and 23 6/7 weeks' gestation with singleton or twin pregnancies at 3 institutions from 2011 to 2018. We excluded pregnancies complicated by fetal anomalies, rupture of membranes immediately after obstetrical procedures (chorionic villus sampling, amniocentesis, cerclage placement, fetal reduction), spontaneous delivery <24 hours after membrane rupture, and contraindications to expectant management. Our primary outcome was the difference in composite maternal morbidity between women choosing expectant management and women choosing termination of pregnancy. We defined composite maternal morbidity as at least 1 of the following: chorioamnionitis, endometritis, sepsis, unplanned operative procedure after delivery (dilation and curettage, laparoscopy, or laparotomy), injury requiring repair, unplanned hysterectomy, unplanned hysterotomy (excluding cesarean delivery), uterine rupture, hemorrhage of >1000 mL, transfusion, admission to the maternal intensive care unit, acute renal insufficiency, venous thromboembolism, pulmonary embolism, and readmission to the hospital within 6 weeks. We compared the demographic and antenatal characteristics of women choosing expectant management with that of women choosing termination of pregnancy and used logistic regression to quantify the association between initial management decision and composite maternal morbidity. RESULTS: We identified 350 women with pregnancies complicated by preterm premature rupture of membranes at <24 weeks' gestation, and 208 women were eligible for the study. Of the 208 women, 108 (51.9%) chose expectant management as initial management, and 100 (48.1%) chose termination of pregnancy as initial management. Among women selecting termination of pregnancy, 67.0% underwent labor induction, and 33.0% underwent dilation and evacuation. Compared to women who chose termination of pregnancy, women who chose expectant management had 4.1 times the odds of developing chorioamnionitis (38.0% vs 13.0%; 95% confidence interval, 2.03-8.26) and 2.44 times the odds of postpartum hemorrhage (23.1% vs 11.0%; 95% confidence interval, 1.13-5.26). Admissions to the intensive care unit and unplanned hysterectomy only occurred after expectant management (2.8% vs 0.0% and 0.9% vs 0.0%). Of women who chose expectant management, 36.2% delivered via cesarean delivery with 56.4% non-low transverse uterine incisions. Composite maternal morbidity rates were 60.2% in the expectant management group and 33.0% in the termination of pregnancy group. After adjusting for gestational age at rupture, site, race and ethnicity, gestational age at entry to prenatal care, preterm premature rupture of membranes in a previous pregnancy, twin pregnancy, smoking, cerclage, and cervical examination at the time of presentation, expectant management was associated with 3.47 times the odds of composite maternal morbidity (95% confidence interval, 1.52-7.93), corresponding to an adjusted relative risk of 1.91 (95% confidence interval, 1.35-2.73). Among women who chose expectant management, 15.7% avoided morbidity and had a neonate who survived to discharge. CONCLUSION: Expectant management for preterm premature rupture of membranes at <24 weeks' gestation was associated with a significantly increased risk of maternal morbidity when compared to termination of pregnancy.

Quality improvement efforts in a safety net institution: Increased diabetes screening is associated with lower HbA1c at diagnosis and improved HbA1c outcomes in youth with type 2 diabetes.

OBJECTIVES: Evaluate whether increased diabetes screening in youth is associated with lower HbA1c at T2D diagnosis and improved HbA1c outcomes in youth. RESEARCH DESIGN AND METHODS: Diabetes screening rates from 2009 to 2018 were calculated. Electronic medical records identified obese youth ages 8-18 with first HbA1c ≥6.5% from 2009 to 2018; chart review confirmed incident T2D. Demographics, BMI and HbA1c values, and use of glucometer and diabetes medications were collected. RESULTS: 142 youth had T2D. Median age was 14 years (range 8-18); 58% were female. 46% were identified on first HbA1c testing. 69 (49%) had 1st HbA1c 6.5%-6.9%, 43 (30%) 7.0%-7.9%, and 30 (21%) ≥8%. Follow-up from 1st to last HbA1c was median 2.6 years (range 0-10). 121 youth had follow-up testing ≥1 year after diagnosis; of these, 87 (72%) had persistent T2D-range HbA1c or were taking diabetes medications. 85% of youth with 1st HbA1c ≥7% had persistent T2D versus 52% of those with 1st HbA1c <7% (p < 0.001). Poorly controlled diabetes at last test was present in 19% of youth with baseline HbA1c 6.5%-6.9%, 30% with 7.0%-7.9%, and 63% with ≥8% (p < 0.001). 47 (68%) with HbA1c <7% were prescribed a glucometer; 9% of youth prescribed a meter and 41% of youth not prescribed a meter had poorly controlled diabetes at last test (p = 0.009). CONCLUSIONS: Youth with HbA1c <7% at diagnosis were less likely to have poorly controlled diabetes at follow-up. Prescription of glucometers for youth with HbA1c in this range was associated with improved HbA1c outcomes and deserves further study including components of glucometer teaching.

Obstetric anal sphincter injuries and other delivery trauma: a US national survey of obstetrician-gynecologists.

INTRODUCTION AND HYPOTHESIS: Obstetric lacerations complicate the majority of deliveries. The application of standardized guidelines for assessing delivery trauma has not been assessed thoroughly in the United States. We recently identified gaps in US midwives' clinical assessment of delivery trauma. We conducted a cross-sectional national survey of practicing obstetricians in the USA to characterize their classification of obstetric lacerations. We hypothesized that attending obstetricians' identification and diagnosis of delivery trauma would be similar to our findings for midwives with frequent inaccuracy. METHODS: We recruited clinically active obstetricians through the Pregnancy-Related Care Research Network. We asked participants to classify (from written definitions) and diagnose (from standard illustrations) common forms of vaginal delivery trauma using the widely employed perineal laceration degree system. We performed bivariate analysis of high- and low-scoring respondents and logistic regression to model characteristics associated with higher diagnostic accuracy. RESULTS: Of the 162 respondents who started the survey, 76% (123) were included for analysis (22% of solicited emails). Overall, we found wide variation in response accuracy with as few as 62% of respondents correctly classifying certain types of lacerations. Only 49 out of 123 (40%) use the Sultan third-degree subclassification system and 67 out of 123 (52%) continue to use the midline/median approach for episiotomies. Providers reporting fewer deliveries per month and fewer publicly insured patients earned higher scores. CONCLUSIONS: Obstetricians in a nationally representative US perinatal provider network inconsistently identify perineal and nonperineal lacerations. We found important clinical knowledge gaps, suggesting that vaginal delivery diagnoses in obstetric quality studies and pelvic floor research might be inaccurate.

Initial Contraceptive Choices of Women Enrolled in a Cluster-Randomized Trial in Southwest Trifinio, Guatemala.

INTRODUCTION: The aim of this analysis is to present initial contraceptive choices of women offered postpartum contraception in rural Guatemala. METHODS: We trained community nurses participating in the delivery of a home-based antepartum and postpartum care program in rural Guatemala in contraceptive implant placement and had them offer condoms, pills, an injection, or an implant at women's home-based 40-day postpartum visit in intervention clusters of a non-blinded, cluster-randomized trial. Women who had already started postpartum contraception or were over the age of 35 were excluded from participation. The primary outcome of the trial was contraceptive use at 3 months postpartum, so this initial analysis describes immediate preferences in the population. RESULTS: Of 208 women enrolled in the study, 108 were in intervention clusters and 100 lived in control clusters. In the intervention group, 32 women declined contraception, 36 women received the injectable, 30 women had an implant placed, 5 women started pills, 2 women chose condoms, and data on 3 women were missing. In the control clusters, 43 women were planning on the injectable, 11 planned on the implant, 10 did not want to start a method, 5 planned on sterilization, 2 aimed for natural family planning, 2 wanted a copper IUD, 1 woman wanted condoms, 18 did not know, and data on 8 women were missing. DISCUSSION: The contraceptive implant, which was not previously available in this community, had high uptake at 27.8% in the intervention group. TRIAL REGISTRATION: Clinicaltrials.gov, NCT04005391; Retrospectively Registered 7/2/2019, https://clinicaltrials.gov/ct2/show/NCT04005391 Protocol: https://doi.org/10.1186/s13063-019-3735-3.

Identification of obstetric anal sphincter injuries (OASIs) and other lacerations: a national survey of nurse-midwives.

INTRODUCTION AND HYPOTHESIS: Clinical quality improvement relies on accurate understanding of current practice. We performed a cross-sectional national survey of certified nurse-midwives (CNMs) assessing classification and identification of obstetric anal sphincter injury (OASI) and other delivery lacerations. We hypothesized laceration diagnoses are frequently inaccurate, and delivery records for obstetric lacerations may be of questionable quality. METHODS: We emailed 6909 American College of Nurse Midwives members an internet-based survey link. Of respondents, we included clinically active CNMs who perform at least one delivery per month. We evaluated laceration knowledge and application using standard descriptive text and images and asked about processes for recording lacerations in the delivery record. RESULTS: We received 1070 (15.5%) completed surveys and 832 (77.8%) met inclusion criteria. Over 50% characterized their OASI training and ability to identify OASI as good/excellent. Most (79%) had never attended education review on OASI. The overall accuracy for classification and identification of perineal lacerations ranged from 49 to 99%. Non-perineal lacerations were frequently categorized using the perineal/OASI system. Half of respondents (51%) document their deliveries in an electronic medical record but a quarter (28%) are not personally responsible for approving delivery data. Younger participants without a doctoral degree, with self-assessed good/excellent laceration training, and caring for < 50% publicly insured patients had higher accuracy for laceration identification and diagnosis. CONCLUSIONS: We found high rates of inaccurate laceration diagnosis and inappropriate application of the perineal OASI degree system, suggesting education and training are needed. Clinical studies that rely on delivery diagnosis of OASI may not be reliable.

Implementing Interconception Care in a Dyadic Adolescent Mother-Child Clinic.

INTRODUCTION: The birth of a second child to an adolescent woman worsens the adverse medical, socioeconomic, educational, and parenting outcomes for the woman and her children. Despite the known high efficacy of long-acting reversible contraception (LARC), many postpartum adolescents use less effective or no contraception. Interconception care (ICC) focuses on modifying maternal risks between pregnancies and promoting healthy birth spacing to improve outcomes for women and children. Research shows that women regularly attend their child's health care visits even if they do not seek care for themselves between pregnancies. These visits present a potential opportunity for providers to educate women on available LARC options. METHODS: In an adolescent mother-child clinic, demographic and ICC screening data were collected on women presenting for well child visits of children age 0-24 months. These data were analyzed using logistic regression models to identify independent predictors of LARC initiation and repeat pregnancy. RESULTS: Mother-child dyads were screened an average of two times in the study period. Participants with only one visit were less likely to initiate LARC. Of the participants, 5.5% became pregnant again, with patients having only one ICC visit being slightly, but not significantly more likely. Hispanic ethnicity and having ≥ 2 visits were significant independent predictors of LARC initiation. The only independent predictor of repeat pregnancy was not initiating LARC. CONCLUSIONS: This study suggests that optimal ICC may rely on consistent and frequent touch points with providers and not solely on the medical management during the interconception period, making it adaptable to a traditional pediatric medical home. Tying the worlds of pediatric and maternal healthcare is pivotal for successful ICC.

Pediatric Group Care: A Systematic Review.

OBJECTIVE: To describe characteristics and outcomes of Group Well-Child Care programs and provide recommendations for future research. METHODS: Informed by Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, an electronic references database, manual search of bibliographies and peer-reviewed journals, and general Internet search were conducted including research published up to July 2019. English language, peer-reviewed research, with provision of medical care were included. Studies without published outcomes, not specific to well-child care, or included only one visit were excluded. Nineteen articles met review criteria. Study quality was assessed using the Downs and Black tool for rigor. RESULTS: Programs typically included an individual medical examination, check-in, and group discussion. Demographics varied by race, ethnicity, age, income level, education and parity, though many were used specifically with underserved populations. Group size ranged from 3 to 10 and lasted an average of 1.5 h over a period of 6-24 months. Evidence suggests group well-child care is as effective as individual care with improvement noted for health-care utilization, weight outcomes, and more content covered. Design elements such as patient-led discussion, self-check-in, inclusion of other family members, and use of a variety of health care professionals and para-professionals may influence these outcomes. CONCLUSIONS: Group well-child care is useful in providing efficient and patient-centered care and shows promise for use in underserved populations. Future research should utilize more rigorous study design and include evaluations of program components and group processes to address implementation challenges and determine effectiveness.

Assessing Inequities in Cervical Cancer Quality of Care and Survival Related to Ethnicity and Socioeconomic Factors.

OBJECTIVE: This study aimed to assess the effect that race and socioeconomic factors have on the provision of care to cervical cancer patients based on National Comprehensive Cancer Network (NCCN) recommended treatment guidelines. MATERIALS AND METHODS: To do this, we completed a retrospective cohort study using the American College of Surgeon's Nation Cancer Database from 2004 to 2016. We identified all reported cases of cervical cancer in that period. Two cohorts were created using self-reported racial demographic data, Hispanic- and White, non-Hispanic-identified patients. Our primary outcome variables were adherence to NCCN-recommended treatment and 5-year overall survival. Adherence to NCCN-recommended treatment was determined by the provision of surgical and/or radiation and/or chemotherapy treatment based on the clinical stage at time of diagnosis and the presence or absence of lymphovascular space invasion. We used bivariate analyses to compare baseline characteristics between the 2 cohorts, multivariable logistic regression to identify independent predictors of 5-year survival, and Cox proportional hazards models to compute survival by group. RESULTS: The difference in NCCN-adherent care between the 2 cohorts was found to be not statistically significant (p = .880). A log rank (Mantel-Cox) χ2 test showed that there was a statistically significant difference between the 2 groups in overall survival with the Hispanic-identified patients living longer (p < .001). Our study is limited by the effect large databases confer on finding statistical significance. CONCLUSIONS: Hispanic-identified women with cervical cancer receive NCCN-compliant care and live longer than their White, non-Hispanic counterparts.

An exploratory study on the association of lifestyle factors with serum etonogestrel concentrations among contraceptive implant users.

PURPOSE: To explore how diet and exercise habits associate with serum etonogestrel concentrations among contraceptive implant users. MATERIALS AND METHODS: We conducted a secondary analysis of healthy, reproductive-age women using etonogestrel implants. This study was registered on ClinicalTrials.gov, NCT03092037. We assessed diet and exercise habits with two validated surveys: Healthy Eating Vital Signs and the Stanford Brief Activity Survey. Participants previously had their serum etonogestrel concentrations measured using a validated liquid-chromatography mass-spectrometry assay. We then used linear modelling to test for associations between survey responses and serum etonogestrel concentrations. RESULTS: Among 129 participants, diet and exercise habits had no significant associations with serum etonogestrel concentrations (p = 0.22-0.72), with inconsistent effects found for increased caloric intake and sedentary lifestyle. CONCLUSION: This exploratory study found no significant effect of diet or exercise habits on steady-state pharmacokinetics among contraceptive implant users. CLINICAL TRIAL REGISTRATION: Clinicaltrials.gov: NCT03092037.

Survival and clinical outcomes of patients with ovarian cancer who were treated on phase 1 clinical trials.

BACKGROUND: Patients with ovarian cancer who are enrolled on phase 1 trials typically have platinum-resistant and heavily pretreated disease, with a poor prognosis. In the current study, the authors assessed prognostic factors and survival in women with recurrent ovarian cancer who were treated on phase 1 clinical trials. METHODS: The authors performed a retrospective analysis of patients treated from 2008 through 2018 at the University of Colorado Cancer Center. Patient characteristics and treatment and toxicity-related survival data were assessed. Descriptive statistics and Cox proportional hazards models were used to identify risk factors associated with survival time. RESULTS: A total of 132 patients were treated on phase 1 clinical trials. Patients had a median age of 59 years (range, 33-88 years) with a median of 5.5 previous chemotherapy lines (range, 1-13 lines). Of the 132 patients, 53 (40%) were treated on multiple phase 1 trials with a median of 1 (range, 0-5) prior phase 1 trial. The overall response rate was 14.7%. The median overall survival was 11.3 months (95% CI, 9.1-13.4 months). Two patients died on trial due to progression of disease whereas no patients died of treatment-related toxicity. Independent risk factors found to be predictive of shorter survival were an elevated cancer antigen 125 (CA 125) level (hazard ratio [HR], 2.8; 95% CI, 1.6-5.2) and albumin <3.5 g/dL (HR, 2.5; 95% CI, 1.65-3.79). A body mass index >25 kg/m2 was predictive of longer survival (HR, 0.65; 95% CI, 0.44-0.96). CONCLUSIONS: In the current single-institution series, patients with heavily pretreated ovarian cancer who were treated on phase 1 clinical trials experienced a median overall survival of 11.3 months. When available, phase 1 clinical trials represent a reasonable treatment option for patients with heavily pretreated ovarian cancer with a preserved performance status.

Cost-effectiveness of apixaban for prevention of venous thromboembolic events in patients after gynecologic cancer surgery.

OBJECTIVE: The cost-effectiveness of apixaban was compared with enoxaparin for prevention of postoperative venothromboembolic events (VTE) in gynecologic oncology patients. Current guidelines recommend thromboprophylaxis with low molecular weight heparin for 28 days following gynecologic cancer surgery, but recent trials suggest that oral apixaban may be a safe, patient-preferred alternative. Apixaban was superior to enoxaparin in a Canadian cost-effectiveness analysis using orthopedics trial data. METHODS: Medication costs, adherence rates, event rates, event costs, and utility decrements were estimated using prior clinical trial data and literature review for input into a short-term decision model to simulate outcomes in a hypothetical cohort of 1000 patients. Incremental cost-effectiveness ratios (ICERs) were calculated as net cost difference per quality-adjusted life year (QALY) gained. Input values at which net costs and QALYs were equivalent and ICERs at upper and lower bounds were evaluated. RESULTS: Using aggregated costs, apixaban was less expensive and more effective than enoxaparin, and remained so or had high value in all scenarios on sensitivity analysis. Examining disaggregated ICERs, apixaban was cost-effective for deep venous thrombosis (DVT); of high value for clinically-relevant non-major bleeding (CRNMB) ($411); low value for major bleeding ($183,465), VTE-related death ($2,711,229), and all-cause mortality ($297,522); and not cost-effective for pulmonary embolism prevention. CONCLUSIONS: Apixaban is more cost-effective than enoxaparin for the prevention of postoperative VTE in patients with gynecologic cancer. This appears to be driven largely by DVT and CRNMB prevention.

African American women with advanced-stage ovarian cancer have worse outcomes regardless of treatment type.

OBJECTIVE: There has been an increase in the use of neoadjuvant chemotherapy in recent years. Our objective was to determine if African American women are more likely to receive neoadjuvant chemotherapy than primary debulking surgery, when compared to their Caucasian counterparts, and the impact of such an approach on oncologic outcomes. METHODS: A retrospective cohort study was performed using the National Cancer Database (NCDB). Women aged 18-90 years, diagnosed with stage IIIC or IV epithelial ovarian cancer between January 2010 through December 2014 were included. Women with unknown treatment or treatments outside of neoadjuvant chemotherapy or primary debulking surgery were excluded. Only women of Caucasian, African American, or Hispanic origin who received either neoadjuvant chemotherapy or primary debulking surgery were included; all other races were excluded. Descriptive statistics were computed, and continuous variables were assessed for normality. Groups were compared using ANOVA or non-parametric medians tests for continuous variables, and chi-squared tests were used for dichotomous or categorical variables. Logistic regression was used to identify predictors of treatment. A p value of 0.05 was considered statistically significant. RESULTS: A total of 19 838 women with stage IIIC and IV epithelial ovarian cancer met the inclusion criteria. A total of 14 988 (75.6%) were treated with primary debulking surgery, while 4850 women (24.4%) were treated with neoadjuvant chemotherapy. Of those treated with neoadjuvant chemotherapy, 24.5% were white, 27.0% were African American, and 22.1% were Hispanic (p=0.005), and when adjusted for confounders, being African American was a predictor of receiving neoadjuvant chemotherapy (adjusted odds ratio (aOR) 1.29, 95% CI 1.10 to 1.51). Ninety-day mortality rates were higher in African American women compared with Caucasian and Hispanic women (2.9% vs 2.0% vs 1.6%, p=0.013). There were no differences in 30-day mortality, 90-day mortality, or status at last contact in African American women, when comparing neoadjuvant chemotherapy and primary debulking surgery. In Caucasian women, outcomes were worse in women receiving neoadjuvant chemotherapy. CONCLUSIONS: Compared to other races, African American women with advanced ovarian cancer are more likely to receive neoadjuvant chemotherapy than primary debulking surgery and had a higher 90-day mortality rate. In African American women there was no difference in outcomes based on treatment type.

Primary and secondary three-month outcomes of a cluster-randomized trial of home-based postpartum contraceptive delivery in southwest Trifinio, Guatemala.

DESIGN: This a cluster-randomized parallel arm pragmatic trial to observe the association of home-based postpartum contraceptive provision, including the contraceptive implant, with implant utilization rates at 3 months post-enrollment. METHODS: In a region of rural Guatemala referred to as the Southwest Trifinio, twelve communities are served by a community-based antenatal and postnatal care program. The communities were combined into eight clusters based on 2017 birth rates and randomized to receive the home-based contraceptive delivery (condoms, pills, injection, implant) during the routine 40-day postpartum visit. All participants receive comprehensive contraceptive counseling beginning at the first antenatal visit, so control clusters received this as part of routine care; this education preceded the study intervention. RESULTS: Once the 12 communities were combined into 8 clusters by expected birth volume and nurse team, which we expected to translate to eventual postpartum visits, the allocation sequence was generated in SAS. Of 208 women enrolled in the study, 108 were in four intervention and 100 in four control clusters. We used descriptive statistics to produce counts and percentages of characteristics of the study population overall and by intervention arm followed by univariate modeling using a mixed effects regression adjusted for cluster. Three-month contraceptive initiation rates were 56.0% in the control clusters compared to 76.8% in the intervention clusters, p < 0.001. Women in control clusters overwhelmingly opted for the injectable contraceptive (94.6%) while women in intervention clusters chose both the injection (61.5%) and the implant (33.7%), p < 0.001. Implant use by 3 months, the primary outcome of the study, was significantly higher in the intervention arm (25.9%) compared to the control arm (3.6%), p < 0.001, RR 1.3 CI [1.2, 1.4]. CONCLUSION: Our study was designed to respond to previously identified barriers to contraceptive uptake, and it was successful. Not only did it increase overall use of contraception by 3 months, but it shifted that contraceptive use away from short-acting methods in favor of longer-acting methods, with high continuation and satisfaction rates and no adverse outcomes reported. TRIAL REGISTRATION: clinicaltrials.gov , NCT04005391 ; Retrospectively Registered 7/2/2019.

Intention to Participate in Group Prenatal Care: Moving Beyond Yes or No.

Group prenatal care (GPNC) is an alternative model to traditional individual care and may improve public health outcomes. Prior studies suggest that interest in GPNC varies widely and few studies have examined characteristics predictive of interest in this model. The purpose of this study was to inform GPNC recruitment efforts by examining likelihood of participation delineated by characteristics and GPNC perceptions. Pregnant participants received information about GPNC then completed a survey measuring demographic, psychosocial, and reproductive characteristics, likelihood to participate in GPNC, and factors influencing selections. Respondents expressed varied levels of likelihood to participate in GPNC; 16.2% low likelihood, 44.9% moderate likelihood, and 38.9% high likelihood. Characteristics were similar between groups, and thus their use is not recommended when targeting recruitment efforts. Benefits outweighed barriers and threats for the high likelihood category, barriers and threats outweighed benefits for the low likelihood category, and benefits, barriers, and threats were balanced for the moderate likelihood category. Accurately assessing likelihood of participating in GPNC efficiently identifies individuals who are clearly either going to decline or participate, as well as promotes targeted recruitment efforts directed at those who are ambivalent. Understanding and addressing perceived benefits, barriers, and threats supports effective GPNC recruitment.

Pre- and post-operative counseling for women on hormonal contraceptives receiving sugammadex at an academic hospital.

Sugammadex is a steroid binder and can potentially bind the estrogens and progestins contained within hormonal contraception. Therefore, the FDA label for sugammadex contains a drug-drug interaction warning between this medication and hormonal contraception, advising that women taking hormonal contraception use a backup contraceptive method or abstinence for seven days after exposure to sugammadex. However, given concerns that this warning may not be appropriately provided to at-risk patients, we conducted a retrospective chart review to identify women administered sugammadex while using hormonal contraception to identify documented counseling on this drug-drug interaction prior to implementation of a formalized counseling process. We reviewed 1000 randomly selected charts from the University of Colorado Hospital between January 2016 and December 2017. We identified 134 women using hormonal contraception at the time of sugammadex exposure; only one patient (0.7%, 95% CI 0.0, 4.1) had documented counseling. One patient had an unintended pregnancy within the same cycle as her exposure to sugammadex. Improved counseling processes are needed to avoid unnecessary risk for unintended pregnancies.