Measurement of Marginal Placental Cord Insertion by Prenatal Ultrasound Was Found Not to Be Predictive of Adverse Perinatal Outcomes.

OBJECTIVES: The clinical importance of marginal cord insertion (MCI) is currently controversial. In this study, we examined the association between MCI and adverse perinatal outcomes. We also evaluated the ultrasound-measured distance from the site of placental cord insertion (PCI) to the placental margin (PCI distance) and perinatal outcomes. METHODS: This was a retrospective cohort study of MCI and control pregnancies presenting to a single institution between September 2014 and August 2016. Marginal cord insertion was diagnosed on routine anatomy ultrasound scans at 20 weeks' gestation. The primary outcome was fetal intolerance to labor. Secondary outcomes of interest included mode of delivery, gestational age at delivery, Apgar scores at 1 and 5 minutes, birth weight, delivery complications, and neonatal intensive care unit admission. The PCI distance was determined by an ultrasound review. Statistical significance was evaluated by a χ2 analysis, descriptive statistics, Wilcoxon tests, and regression models with log-transformed outcomes, the PCI distance, or both as needed. RESULTS: Of 675 abnormal cord insertion cases, we identified 183 that met inclusion criteria. We found no statistically significant association between MCI and fetal intolerance to labor (odds ratio, 1.24 [95% confidence interval, 0.55-2.80]; P = .71) or secondary outcomes. Furthermore, we found no significant correlation between perinatal outcomes and the PCI distance. CONCLUSIONS: Our study suggests that MCI pregnancies, regardless of the specific PCI distance, might not be at increased risk of adverse perinatal outcomes. This finding questions the need for heightened antepartum surveillance of this patient population.

Outcomes of Sacral Nerve Stimulation for Treatment of Refractory Overactive Bladder Among Octogenarians.

OBJECTIVE: Sacral nerve stimulation (SNS) is an effective treatment for refractory overactive bladder (OAB). However, advanced age is often cited as a reason to avoid SNS in the elderly. This study evaluates the safety and efficacy of SNS for refractory OAB among our octogenarian population. METHODS: A retrospective review from a single institution was performed on all SNS lead placements from December 1998 to June 2017 for refractory OAB. Octogenarians were characterized as 80 years of age or older at the time of Stage I. Efficacy and safety were determined by the rate of progression to Stage II, subsequent need for multimodal therapy, and rate of surgical revision and explantation. All patients were followed for a minimum of 12 months. RESULTS: Of 374 patients in this study, 37 (9.9%) were octogenarians. There was no difference in gender, race, smoking history, or prior OAB treatment regimens between cohorts. The rate of progression to Stage II was 56.8% for octogenarians compared to 60.5% for nonoctogenarians (p = 0.66). The rate of surgical revision, explantation, and need for multimodal therapy did not differ between groups. Subgroup analysis of octogenarians did not reveal any significant differences between successful and nonsuccessful Stage I patients. CONCLUSIONS: The safety and efficacy of SNS was similar between cohorts. This result suggests that SNS is a safe and effective therapy that should be considered among the treatment options for refractory OAB in octogenarian patients. Further studies are needed to determine predictive factors of Stage I success in elderly patients.

The economic impact of surgical care for morbidly obese endometrial cancer patients: a nationwide study.

BACKGROUND: Obesity significantly impacts the cost of cancer treatment, yet the impact of morbid obesity on inpatient hospital charges related to endometrial cancer treatment is not well-defined. OBJECTIVES: The purpose of this study was to determine the charges that are associated with inpatient surgery, hospitalization, and postoperative care of morbidly obese patients with endometrial cancer. STUDY DESIGN: Data were obtained from the National Inpatient Sample from 2010. Chi-square test, t-test, and linear regression were used for statistical analyses. RESULTS: Six thousand five hundred sixty patients who underwent hysterectomy for endometrial cancer were identified. Mean age was 62 years (range, 22-99 years). The majority were white (78%), and the remainder were black (10%), Hispanic, (8%), Asian (3%), and Native American (1%). Insurance types were private (45%), Medicare (45%), Medicaid (5%), and uninsured (7%). One thousand eighty-eight of these patients (17%) were coded as morbidly obese. The mean postoperative stay for the morbidly obese was 4.0 days (range, 0-46 days) compared with 3.5 days (range, 0-81 days) for the non-morbidly obese patients (P < .01). Morbidly obese patients required more intensive care with mechanical ventilation (5.5% vs 1.6%; P < .01). The median hospital charges were higher for morbidly obese patients compared with their counterparts ($46,654 vs $41,164; P < .01). After adjustment for charges that were associated with insurance type, hospital type, and the surgery that was performed, the incremental increase in hospital charges that were associated with treating the morbidly obese patient was $5096 per patient (95% confidence interval, $2593-$7598; P < .01). CONCLUSION: In this economic analysis, the health care charges that were associated with inpatient endometrial cancer treatment in the morbidly obese patient was significantly higher compared the non-morbidly obese patient. Resources are needed to support the needs of this population, and programs to encourage weight loss and optimize general health should be encouraged.

Applications for oncologic drugs: a descriptive analysis of the oncologic drugs advisory committee reviews.

BACKGROUND: Despite advances in cancer research, the majority of drug applications submitted to the U.S. Food and Drug Administration (FDA) are not approved. It is important to identify the concerns of the Oncologic Drugs Advisory Committee (ODAC) from rejected applications. METHODS: All applications referred to the ODAC from 2001 to 2012 were reviewed. RESULTS: Of 46 applications, 31 (67%) were for full and 15 (33%) were for supplemental approval, 34 (74%) were for solid and 12 (26%) were for hematologic tumors. In all, 22 (48%) were not approved. ODAC comments addressed missing or inadequate data (65%), excessive toxicity (55%), inappropriate study endpoints (45%), poor study design (40%), and insufficient sample size (30%). To define efficacy, 19 applications used response rates (RR) (median = 38%), and 19 applications used hazard ratios (HR) (median = 0.67). For all organ systems combined, the median cumulative grade 3 or 4 toxicity was 64%. Drugs with higher RR, lower HR, and lower toxicity were more likely to be approved versus other drugs (89% vs. 45%; p = .02). Over time (2001-2004, 2005-2008, 2009-2012), there was an increase in the following: number of applications submitted for review (from 11 to 12 to 23, respectively), number of approvals (from 6 to 6 to 12, respectively), and proportion of trials using progression-free survival as a primary endpoint (from 0% to 50% to 70%, respectively; p = .01). CONCLUSION: Of all applications, common ODAC concerns included inadequate data, excessive toxicity, and inappropriate study endpoints. Over time, there was an approximate doubling of FDA application submissions and approved oncology drugs.

An economic analysis of robotic versus laparoscopic surgery for endometrial cancer: costs, charges and reimbursements to hospitals and professionals.

OBJECTIVE: To determine the actual costs, charges, and reimbursements associated with robotic vs. laparoscopic surgery for endometrial cancer. METHODS: Data were collected from hospital billing records, MD professional group billing records, tumor registry, and medical records on operations performed by a single surgeon from one institution between 2008 and 2010. For comparison, surgical groups were matched based on age, histology, and stage of disease over the same time period. RESULTS: Of 54 patients, 27 underwent robotic surgery (RS) and 27 had laparoscopic surgery (LS). The median age was 57 years. There were no statistically significant differences between the groups based on age, stage, and histology. The hospital charges for RS were higher at $64,266 vs. $55,130 for LS (p=0.036). However, the reimbursement to the hospital was not statistically different at $13,003 for RS and $10,245 for LS (p=0.29). Operating suite, room and board, anesthesia, post anesthesia care unit, and pathology accounted for over 90% of hospital charges. The surgeon charges for RS and LS were $6824 and $6327, respectively (p=0.033) and the anesthesiologist charges were $4049 and $2985, respectively (p=0.001). However, there were no differences in reimbursement to the surgeon (p=0.74) and anesthesiologist (p=0.84) between the two operative approaches. CONCLUSIONS: Our data showed that the direct costs and charges associated with robotic surgery were higher compared to laparoscopic surgery. However, actual reimbursements to the hospital, surgeon, and anesthesiologist were not significantly different between the two surgical approaches.

Incidence of Pelvic Floor Disorders in US Army Female Soldiers.

OBJECTIVE: To determine the incidence of pelvic floor disorders (PFD) among active-duty US Army female soldiers. MATERIALS AND METHODS: We studied 102,015 women for incident PFD using the Stanford Military Data Repository, which comprises medical, demographic and service-related information on all soldiers on active duty in the US Army during 2011-2014. Cox proportional hazards estimated adjusted associations with PFD diagnoses. In the adjusted models, military-specific characteristics and fitness were evaluated alongside known PFD predictors. RESULTS: Among 102,015 subjects at risk there was a cumulative incidence of 6.4% over a mean of 27 months (median 29, range 1-42). In adjusted models, obese soldiers were more likely to have a PFD compared to those of normal weight (hazard ratio [HR] 1.23, confidence interval [CI] 1.14-1.34, P <0.001) and those with recent weight gain were more likely to have a PFD compared to those without (HR 1.32, CI 1.24-1.40, P <0.05). Women with the lowest physical fitness scores were more likely to have a PFD (HR 1.14, CI 1.04-1.25) compared to those with the highest scores. CONCLUSION: Over a median follow-up time of 29 months, 1 in 15 women in this active-duty cohort was diagnosed with a PFD. Optimizing risk factors including body mass index and physical fitness may benefit the pelvic health of female soldiers, independent of age, children, and years of service.

Peroxisome proliferator-activated receptor gamma agonist as a novel treatment for interstitial cystitis: A rat model.

Purpose: To understand the therapeutic potential of pioglitazone, a peroxisome proliferator-activated receptor gamma (PPAR-γ) agonist with a propensity to cause bladder mucosal proliferation, on interstitial cystitis (IC) in a rat model. Materials and Methods: Using a previously described animal model for IC, Sprague-Dawley rats were treated with biweekly cyclophosphamide injections (35 mg/kg) to induce cystitis. Animals were divided into 4 groups (n=6 for each group): IC plus daily sham saline gavage (IC+Pio-), IC plus daily pioglitazone gavage (15 mg/kg) (IC+Pio+), normal rats with daily pioglitazone (IC-Pio+), and normal rats with neither IC nor pioglitazone (IC-Pio- or Control). At the end of four weeks, urinary frequency and bladder capacity were measured. Histologic examination of urothelial integrity was also performed. Results: Average voids per hour were significantly lower in IC+Pio+ (4.0±1.9) vs. IC+Pio- (10.0±2.4) rats (p<0.01) and were similar to IC-Pio+ (6.0±1.4) and IC-Pio- (6.0±1.5) controls. Cystometric capacity was significantly higher in IC+Pio+ (0.945±0.122 mL) vs. IC+Pio- rats (0.588±0.165 mL, p=0.01) and was comparable to IC-Pio- capacity (0.817±0.196 mL) and IC-Pio+ capacity (0.941±0.188 mL). Urothelial structural integrity was improved in IC+Pio+ rats versus IC+Pio- rats upon histologic observation. Conclusions: Pioglitazone, a PPAR-γ agonist, improved bladder function in cyclophosphamide-induced cystitis by both observed urinary frequency and measured cystometric capacity. Urothelial structural integrity was also improved. Pioglitazone, due to a propensity to cause bladder mucosal proliferation, may prove useful for treating IC, and deserves further investigation.

Healthcare providers' perspectives on the social reintegration of patients after surgical fistula repair in the eastern Democratic Republic of Congo.

OBJECTIVE: To understand perspectives of local health providers on the social reintegration of patients who have undergone fistula repair in the eastern Democratic Republic of Congo. METHODS: In a qualitative study, semi-structured individual interviews were conducted with patient-care professionals working with women with fistula at HEAL Africa Hospital (Goma) and Panzi Hospital (Bukavu) between June and August 2011. The interviews were transcribed and themes elicited through manual coding. RESULTS: Overall, 41 interviews were conducted. Successful surgical repair was reported to be the most important factor contributing to patients' ability to lead a normal life by all providers. Family acceptance-especially from the husband-was deemed crucial for reintegration by 39 (95%) providers, and 29 (71%) believed this acceptance was more important than the ability to work. Forty (98%) providers felt that, on the basis of African values, future childbearing was key for family acceptance. Because of poor access and the high cost of cesarean deliveries, 28 (68%) providers were concerned about fistula recurrence. CONCLUSION: Providers view postsurgical childbearing as crucial for social reintegration after fistula repair. However, cesarean deliveries are costly and often inaccessible. More work is needed to improve reproductive health access for women after fistula repair.

Interprofessional Obstetric Ultrasound Education: Successful Development of Online Learning Modules; Case-Based Seminars; and Skills Labs for Registered and Advanced Practice Nurses, Midwives, Physicians, and Trainees.

Ultrasound is an important aid in the clinical diagnosis and management of normal and complicated pregnancy and childbirth. The technology is widely applied to maternity care in the United States, where comprehensive standard ultrasound examinations are routine. Targeted scans are common and used for an increasing number of clinical indications due to emerging research and a greater availability of equipment with better image resolution at lower cost. These factors contribute to an increased demand for obstetric ultrasound education among students and providers of maternity care, despite a paucity of data to inform education program design and evaluation. To meet this demand, from 2012 to 2015 the University of California, San Francisco nurse-midwifery education program developed and implemented an interprofessional obstetric ultrasound course focused on clinical applications commonly managed by maternity care providers from different professions and disciplines. The course included matriculating students in nursing and medicine, as well as licensed practitioners such as registered and advanced practice nurses, midwives, and physicians and residents in obstetrics and gynecology and family medicine. After completing 10 online modules with a pre- and posttest of knowledge and interprofessional competencies related to teamwork and communication, trainees attended a case-based seminar and hands-on skills practicum with pregnant volunteers. The course aimed to establish a foundation for further supervised clinical training prior to independent practice of obstetric ultrasound. Course development was informed by professional guidelines and clinical and education research literature. This article describes the foundations, with a review of the challenges and solutions encountered in obstetric ultrasound education development and implementation. Our experience will inform educators who wish to facilitate obstetric ultrasound competency development among new and experienced maternity care providers in academic and clinical settings. This article is part of a special series of articles that address midwifery innovations in clinical practice, education, interprofessional collaboration, health policy, and global health.

Fistula after attended delivery and the challenge of obstetric care capacity in the eastern Democratic Republic of Congo.

OBJECTIVE: To analyze the history of women with fistula in the eastern Democratic Republic of Congo (DRC) to understand the determinants of fistula development. METHODS: In a retrospective observational study, data were analyzed from a survey of all women who underwent surgical fistula repair at HEAL Africa Hospital, Goma, between April 1, 2009, and March 1, 2012. Characteristics and obstetric histories were obtained by self-report. RESULTS: The mean age of the 202 participants at treatment was 30.7 years (range 5-69). The mean duration of fistula was 45.6 months (range 0-600). In total, 171 (91.4%) fistulas were caused by obstructed labor, and 147 (86.5%) were vesicovaginal. Most women (129/175 [73.8%]) reported having received care during early labor under the supervision of a nurse or doctor in a healthcare facility. Among 176 women for whom delivery data were available, 102 (57.9%) delivered at a hospital, 42 (23.8%) at a health center, and 32 (18.2%) at home. Only 46 (26.3%) of 175 women were transferred to a higher level of care during labor. CONCLUSIONS: In the eastern DRC, efforts to enable transport to a healthcare facility and to encourage attended births must be accompanied by improvements in the capacity of existing facilities and in the training of staff to enable the timely diagnosis of labor abnormalities and appropriate intervention.

Teaching neuroimages: infant with glutaric aciduria type 1 presenting with infantile spasms and hypsarrhythmia.

A 7-month-old boy with glutaric aciduria type 1 (GA1) presented with 1 week of clustered flexor spasms. Examination revealed mild axial hypotonia without encephalopathy. Video-EEG monitoring revealed hypsarrhythmia and infantile spasms (figure, A). MRI showed acute basal ganglia injury (figure, B). After 3 weeks of prednisolone treatment, 5-month follow-up showed continued resolution of hypsarrhythmia and spasms.