Efficacy and Safety of Vibegron for the Treatment of Overactive Bladder in Women: A Subgroup Analysis From the Double-Blind, Randomized, Controlled EMPOWUR Trial.

IMPORTANCE: The international phase 3 EMPOWUR trial demonstrated efficacy and safety of vibegron, a newer ß 3 -adrenergic receptor agonist, in adults with overactive bladder (OAB). Women are disproportionately affected by OAB, especially those with bothersome symptoms, such as urge urinary incontinence (UUI). OBJECTIVE: This subgroup analysis from EMPOWUR assessed efficacy and safety of vibegron in women. STUDY DESIGN: In EMPOWUR, patients with OAB were randomized 5:5:4 to 12 weeks of treatment with once-daily vibegron 75 mg, placebo, or tolterodine 4-mg extended release. Efficacy end points included change from baseline at week 12 in mean daily number of micturitions, UUI episodes, and urgency episodes. Safety was assessed through adverse events (AEs). RESULTS: Of the patients included in the analysis, 1286 (84.9%) were women (vibegron, n = 463; placebo, n = 459; tolterodine, n = 364). At week 12, women receiving vibegron showed significant reductions (95% confidence intervals of least squares mean differences does not include 0) from baseline versus placebo in mean daily micturitions, UUI episodes, and urgency episodes, with least squares mean differences (95% confidence intervals) of -0.5 (-0.8 to -0.2), -0.7 (-1.0 to -0.4), and -0.8 (-1.3 to -0.4), respectively. Treatment-emergent AE incidence was similar with vibegron (39%) and placebo (35%); the most common AE with incidence higher with vibegron (4.3%) than placebo (2.6%) was headache. CONCLUSIONS: In this subgroup analysis, women receiving vibegron showed significant reductions in key efficacy end points versus placebo and favorable safety profile, consistent with the overall results from EMPOWUR, suggesting that vibegron is efficacious and safe for the treatment of OAB in this patient population.

Patient Portal Activation and Use in Hospitalized Children at an Academic Medical Center.

OBJECTIVES: Electronic health records are becoming increasingly common tools for storing and sharing patient health information. Many vendors offer patient "portals" as a way for patients and/or proxies to view test results and communicate with their health care teams. Few researchers have looked at patient portals in the inpatient pediatric population. Our objectives were to describe portal activation and use and factors associated with these end points for hospitalized children. METHODS: Retrospective, single-center study of pediatric patients birth through 17 years old who had at least one hospital admission and one or more inpatient diagnostic test performed between January 1, 2018, to December 31, 2018. Portal use was defined as viewing one or more test result. Multivariate logistic regression analyzed the association between patient characteristics and portal account activation and use. RESULTS: A total of 5862 patients with 170 685 diagnostic test results were included. A total of 40.9% of patients had an activated account, and 20.3% viewed one or more test result. Factors associated with an increased odds of portal activation and/or use included English as preferred language, white race, commercial insurance, multiple admissions, previous outpatient testing, and having both laboratory and imaging inpatient studies performed. CONCLUSIONS: In this study, we highlight the underuse of the patient portal in the inpatient pediatric population, especially for patients whose preferred language is not English, self-identify as multiracial and are publicly insured or uninsured. Concerted efforts to eliminate health care disparities in relation to portal activation are needed.

Data on the relationship between acetone, ethylene glycol, isopropanol, methanol, and propylene glycol serum/plasma concentrations and osmolal gaps in patients at an academic medical center.

Ingestion of toxic alcohols other than ethanol (ethylene glycol, methanol, isopropanol, and propylene glycol) can cause life-threatening complications including altered level of consciousness, respiratory depression, and organ damage from metabolites. Many hospitals lack the ability to specifically analyze these compounds using gas chromatography, gas chromatography/mass spectrometry, or by enzymatic assays for ethylene glycol. Consequently, the presence of these compounds in blood is often ascertained indirectly by laboratory testing for acid-base status, osmolal gap, and anion gap. In the related research article, we analyzed 260 samples originating from 158 unique patients that had osmolal gap and specific testing for toxic alcohols performed on serum/plasma at an academic medical center central clinical laboratory. The data in this article provide the patient demographic, osmolal gap (and associated laboratory tests needed for this calculation), ethanol concentration by enzymatic assay, specific testing for toxic alcohols (ethylene glycol, isopropanol, methanol, propylene glycol) and acetone, anion gap, clinical history, antidotal treatment, and estimated timing of ingestion. The analyzed data is provided in the supplementary tables included in this article. Bias plots of osmolal gap estimations are included in a figure. The dataset reported is related to the research article entitled "Correlation of Osmolal Gap with Measured Concentrations of Acetone, Ethylene Glycol, Isopropanol, Methanol, and Propylene Glycol in Patients at an Academic Medical Center" [1].

Correlation of osmolal gap with measured concentrations of acetone, ethylene glycol, isopropanol, methanol, and propylene glycol in patients at an academic medical center.

The ingestion of toxic alcohols including methanol, ethylene glycol, and isopropanol remains a significant public health problem. These compounds can cause central nervous system depression and, for methanol and ethylene glycol, organ damage from toxic metabolites. The presence of these compounds in serum/plasma can often be determined and monitored by measuring the osmolal gap (OG). However, other compounds originating from endogenous or exogenous sources, such as propylene glycol and acetone, can also increase the OG. Conversion factors can be used to estimate specific concentrations of acetone and toxic alcohols from OG. In this retrospective study, data were analyzed for 260 samples originating from 158 unique patients that had determination of both OG and concentrations for toxic alcohols at an academic medical center central laboratory. Specific analysis included gas chromatography (acetone, isopropanol, methanol, ethylene glycol, propylene glycol) and/or enzymatic assay (ethylene glycol). Many samples also contained ethanol. The data was grouped by type of ingestion. The present study analyzed the relationship between the OG calculated from measured plasma/serum osmolality and the OG estimated by applying conversion factors to measured concentrations of the different compounds. The correlations tend to be linear and vary by compound, with methanol and ethylene glycol having the highest R2 values of 0.93 and 0.95, respectively, consistent with other published studies. Higher variability was seen for the data for isopropanol and acetone. For each of the data subsets, the estimated toxic alcohol concentration calculated using conversion factors from OG tends to overestimate the actual concentration of the compound. Overall, the present study demonstrates the generally linear relationship between OG determined by osmolality and the OG estimated using measured concentrations of acetone and toxic alcohols.

Expert Insights on Triple-Negative Breast Cancer: Preparing for the Next Wave of Treatments.

Heather R. Greene, MSN, FNP, AOCNP®, and Lee S. Schwartzberg, MD, FACP, discussed the current and future treatment landscape for triple-negative breast cancer, including recent and emerging data on approved treatments, novel therapeutic options being investigated, and best practices for identifying and monitoring adverse events associated with PARP and immune checkpoint inhibitors at JADPRO Live 2019.

Hormone Receptor-Positive, HER2-Negative Breast Cancer: Recent Advances and Best Practices.

Lee Schwartzberg, MD, FACP, and Heather Greene, MSN, FNP, AOCNP®, reviewed optimal therapy for patients with hormone receptor-positive, HER2-negative breast cancer, as well as the management of adverse events associated with treatment.

Collaborative Management of Patients With Estrogen Receptor-Positive Breast Cancer.

Cyclin-dependent kinase (CDK) inhibitors represent a new form of cytotoxic chemotherapy. Advanced practitioners can read this article to find out about the science behind CDK inhibition, when CDKs are indicated, how to monitor for and manage side effects, as well as when and how to dose adjust.

Community Health Workers and Family Medicine Resident Education: Addressing the Social Determinants of Health.

BACKGROUND AND OBJECTIVES: Neither the health care system nor the training of medical residents focus sufficiently on social determinants of health. Community health workers (CHWs) are a growing presence in health care settings. Culturally and linguistically competent, typically they are from underserved communities and spend more time addressing social determinants of health than others on the health care team. However, CHWs are an infrequent presence in resident clinical training environments. The University of New Mexico Family Medicine Residency placed family medicine residents at a community clinic in Albuquerque managed by CHWs, recognizing that CHWs' collaboration with residents would enhance resident competency in multiple domains. Residents gained skills from CHWs in inter-professional teamwork, cultural proficiency in patient care, effective communication, provision of cost-conscious care, and advocating for both individual and community health. Our model recognizes the value of CHW skills and knowledge and creates a powerful rationale for greater recognition of CHW expertise and integration of CHWs as members of the care team.

Misoprostol for intrauterine device insertion in nulliparous women: a randomized controlled trial.

OBJECTIVE: To examine the effects of preprocedure misoprostol on intrauterine device (IUD) placement in nulliparous women. STUDY DESIGN: In this randomized controlled double-blind trial at the University of New Mexico reproductive health clinic, nulliparous women requesting an IUD were randomized to 400 mcg of buccal misoprostol or placebo 2-8 hours before insertion. Primary outcomes included pain on a 10-cm visual analog scale and women's perception of the value of delaying insertion for an effective medication. Provider ease of insertion and need for adjunctive insertion measures were also assessed, on a visual analog scale. Participants indicated maximum pain after IUD insertion, pain level they would tolerate to avoid delay in IUD insertion, and preference for IUD insertion without delay if an effective medication was available. RESULTS: Of 85 women enrolled, 3 were ineligible; 42 were randomized to misoprostol and 40 to placebo. There were no differences between groups in worst insertion pain, (5.8 ± 2.0 vs 5.9 ± 2.0, P = .94), provider ease of insertion (2.2 ± 2.2 vs 2.5 ± 2.2; P = .54) or adjunctive measures (14% vs 25%; P = .27). The groups were willing to tolerate the same mean pain (4.9 ± 2.5 vs 5.7 ± 2.4, P = .18) to avoid waiting for medication. The majority of women (85%) preferred to wait for an effective medication. CONCLUSION: Misoprostol for nulliparous women did not decrease pain or improve the ease of insertion of an IUD. Most women were willing to wait for a medication that decreases pain, indicating a need to pursue alternatives for pain control with IUD insertion.

In vivo light scattering for the detection of cancerous and precancerous lesions of the cervix.

A noninvasive optical diagnostic system for detection of cancerous and precancerous lesions of the cervix was evaluated in vivo. The optical system included a fiber-optic probe designed to measure polarized and unpolarized light transport properties of a small volume of tissue. An algorithm for diagnosing tissue based on the optical measurements was developed that used four optical properties, three of which were related to light scattering properties and the fourth of which was related to hemoglobin concentration. A sensitivity of ~77% and specificities in the mid 60% range were obtained for separating high grade squamous intraepithelial lesions and cancer from other pathologies and normal tissue. The use of different cross-validation methods in algorithm development is analyzed, and the relative difficulties of diagnosing certain pathologies are assessed. Furthermore, the robustness of the optical system for use by different doctors and to changes in fiber-optic probe are also assessed, and potential improvements in the optical system are discussed.

Detection of cervical intraepithelial neoplasias and cancers in cervical tissue by in vivo light scattering.

OBJECTIVE: To examine the utility of in vivo elastic light scattering measurements to identify cervical intraepithelial neoplasias (CIN) 2/3 and cancers in women undergoing colposcopy and to determine the effects of patient characteristics such as menstrual status on the elastic light scattering spectroscopic measurements. MATERIALS AND METHODS: A fiber optic probe was used to measure light transport in the cervical epithelium of patients undergoing colposcopy. Spectroscopic results from 151 patients were compared with histopathology of the measured and biopsied sites. A method of classifying the measured sites into two clinically relevant categories was developed and tested using five-fold cross-validation. RESULTS: Statistically significant effects by age at diagnosis, menopausal status, timing of the menstrual cycle, and oral contraceptive use were identified, and adjustments based upon these measurements were incorporated in the classification algorithm. A sensitivity of 77±5% and a specificity of 62±2% were obtained for separating CIN 2/3 and cancer from other pathologies and normal tissue. CONCLUSIONS: The effects of both menstrual status and age should be taken into account in the algorithm for classifying tissue sites based on elastic light scattering spectroscopy. When this is done, elastic light scattering spectroscopy shows good potential for real-time diagnosis of cervical tissue at colposcopy. Guiding biopsy location is one potential near-term clinical application area, while facilitating "see and treat" protocols is a longer term goal. Improvements in accuracy are essential.

In vivo light scattering measurements for detection of precancerous conditions of the cervix.

OBJECTIVE: To examine the utility of in vivo elastic light scattering measurements to diagnose high grade squamous interepithelial lesions (HSIL) of the cervix. METHODS: A newly developed fiber optic probe was used to measure light transport in the cervical epithelium of 36 patients undergoing standard colposcopy. Both unpolarized and polarized light transport were measured in the visible and near-infrared. Spectroscopic results of 29 patients were compared with histopathology of the measured sites using ROC curves, MANOVA and logistic regression. RESULTS: Three spectroscopic parameters are statistically different for HSIL compared with low-grade lesions and normal tissue. When these three spectroscopic parameters are combined, retrospective sensitivities and specificities for HSIL versus non-HSIL are 100% and 80%, respectively. CONCLUSIONS: Reflectance measurements of elastically scattered light show promise as a non-invasive, real-time method to discriminate HSIL from other abnormalities and normal tissue. These results compare favorably with those obtained by fluorescence alone and by fluorescence combined with light scattering.

Changing trends in gestational trophoblastic disease.

OBJECTIVE: The New Mexico Tumor Registry (NMTR) and Surveillance, Epidemiology and End Results (SEER) registries were utilized to determine (30+)-year trends in gestational trophoblastic disease and choriocarcinoma. STUDY DESIGN: Age-adjusted incidence rates of gestational trophoblastic disease per 100,000 woman-years (1973-2003) and ratios per live births and pregnancies were calculated using data abstracted from the NMTR and state vital records. SEER data (1973-2002) were used to calculate age-adjusted incidence rates, estimated annual percentage change (EAPC) and relative survival rates for choriocarcinoma. RESULTS: In New Mexico there were 1,153 cases affecting 377 non-Hispanic whites, 504 Hispanics and 241 American Indians, with respective incidence rates of 3.494, 5.150 and 9.991 (p < 0.0001). American Indian incidence rates decreased 53.3%, from 13.34 (1988-1992) to 6.23 (1998-2002). Within SEER (1973-2002), there were 504 gestational choriocarcinomas. The 30-year incidence rate was 0.132 and decreased by 37.7% (EAPC, -2.1% per year; p=0.0001)-by 40.1% for whites, 55.9% for blacks and 62.1% for others. However, over the previous 10 years, rates among blacks (0.097 vs. 0.259, p = 0.01) and for distant disease (0.044 vs. 0.071, p = 0.046) increased. CONCLUSION: Disparities in incidence rates by race/ethnicity in New Mexico are decreasing. An increase in rates among blacks and distant disease diagnosis may be the consequence of fewer regional trophoblastic centers in the United States.

Resolving medication discrepancies.

When elderly patients transition from one health care setting to another they are at increased risk of experiencing fragmented care. One of the most common manifestations of this lack of continuity is medication discrepancy. These differences, such as omission of medications, dosing errors, and duplication of therapy, are a significant safety issue for seniors. This case study describes a 76-year-old woman who is a new resident in an assisted living facility and is referred to the consultant pharmacist for medication review and evaluation of possible adverse drug events. In reviewing the drug regimen, the pharmacist uncovered medication discrepancies; other members of the health care team were unaware of them. These discrepancies may have contributed to some of the patient's current health problems. This case study demonstrates the role of the consultant pharmacist during transitions of care setting and reviews strategies that the pharmacist can use to identify and resolve medication discrepancies.

Diabetes expertise: a subspecialty on a general medical unit.

A medical unit developed a subspecialty in diabetes care by increasing the expertise of its staff nurses. A task force was formed to set goals and create an action plan. An educational curriculum was developed, implemented, and evaluated. Medical staff nurses were integrated as diabetes educators and now provide 24-hour diabetes specialty care coverage for the hospital.