A prospective study to assess the effectiveness and safety of the BlueWind System in the treatment of patients diagnosed with urgency urinary incontinence.

BACKGROUND: Overactive bladder (OAB) affects one in six adults in Europe and the United States and impairs the quality of life of millions of individuals worldwide. When conservative management fails, third-line treatments including tibial neuromodulation (TNM) is often pursued. TNM has traditionally been accomplished percutaneously in clinic. OBJECTIVE: A minimally invasive implantable device activated by a battery-operated external wearable unit has been developed for the treatment of urgency urinary incontinence (UUI), mitigating the burden of frequent clinic visits and more invasive therapies that are currently commercially available. METHODS: A prospective, multicenter, single-arm, open-label, pivotal study evaluated the safety and effectiveness of the device in adult females with UUI (i.e., wet OAB) (BlueWind Implantable Tibial Neuromodulation [iTNM] system; IDE number #G200013; NCT03596671). Results with the device were previously published under the name RENOVA iStim, which has been since renamed as the Revi™ System. Approximately 1-month post-implantation of the device, participants delivered therapy at their convenience and completed a 7-day voiding diary before visits 6- and 12-months post-treatment initiation. The primary efficacy and safety endpoints were the proportion of responders to therapy ( ≥ 50% improvement on average number of urgency-related incontinence episodes) and incidence of adverse events from implantation to 12-month post-activation. RESULTS: A total of 151 participants, mean age 58.8 (SD: 12.5), were implanted; 144 and 140 completed the 6- and 12-month visits, respectively. The participants demonstrated mean baseline of 4.8 UUI/day (SD 2.9) and 10 voids/day (SD 3.3). Six and 12-months post-activation, 76.4% and 78.4% of participants, respectively, were responders to therapy in an intent-to-treat analysis. Of the 139 participants with completed 12-month diaries, 82% were responders, 50% were classified as "dry" (on at least 3 consecutive diary days), and 93.5% of participants reported that their symptoms improved. No implanted participant experienced an SAE related to the procedure or device. CONCLUSIONS: iTNM, delivered and powered by a patient-controlled external wearable communicating with an implant, demonstrated clinically meaningful and statistically significant improvement in UUI symptoms and a high safety profile. This therapy highlights the value of patient-centric therapy for the treatment of UUI.

A strategy to identify event specific hospitalizations in large health claims databases.

BACKGROUND: Health insurance claims data offer a unique opportunity to study disease distribution on a large scale. Challenges arise in the process of accurately analyzing these raw data. One important challenge to overcome is the accurate classification of study outcomes. For example, using claims data, there is no clear way of classifying hospitalizations due to a specific event. This is because of the inherent disjointedness and lack of context that typically come with raw claims data. METHODS: In this paper, we propose a framework for classifying hospitalizations due to a specific event. We then tested this framework in a private health insurance claims database (Symphony) with approximately 4 million US adults who tested positive with COVID-19 between March and December 2020. Our claims specific COVID-19 related hospitalizations proportion is then compared to nationally reported rates from the Centers for Disease Control by age. RESULTS: Across all ages (18 +) the total percentage of Symphony patients who met our definition of hospitalized due to COVID-19 was 7.3% which was similar to the CDC's estimate of 7.5%. By age group, defined by the CDC, our estimates vs. the CDC's estimates were 18-49: 2.7% vs. 3%, 50-64: 8.2% vs. 9.2%, and 65 + : 14.6% vs. 28.1%. CONCLUSIONS: The proposed methodology is a rigorous way to define event specific hospitalizations in claims data. This methodology can be extended to many different types of events and used on a variety of different types of claims databases.

Pregnancy outcomes in women with kidney transplant: Metaanalysis and systematic review.

BACKGROUND: Reproductive function in women with end stage renal disease generally improves after kidney transplant. However, pregnancy remains challenging due to the risk of adverse clinical outcomes. METHODS: We searched PubMed/MEDLINE, Elsevier EMBASE, Scopus, BIOSIS Previews, ISI Science Citation Index Expanded, and the Cochrane Central Register of Controlled Trials from date of inception through August 2017 for studies reporting pregnancy with kidney transplant. RESULTS: Of 1343 unique studies, 87 met inclusion criteria, representing 6712 pregnancies in 4174 kidney transplant recipients. Mean maternal age was 29.6 ± 2.4 years. The live-birth rate was 72.9% (95% CI, 70.0-75.6). The rate of other pregnancy outcomes was as follows: induced abortions (12.4%; 95% CI, 10.4-14.7), miscarriages (15.4%; 95% CI, 13.8-17.2), stillbirths (5.1%; 95% CI, 4.0-6.5), ectopic pregnancies (2.4%; 95% CI, 1.5-3.7), preeclampsia (21.5%; 95% CI, 18.5-24.9), gestational diabetes (5.7%; 95% CI, 3.7-8.9), pregnancy induced hypertension (24.1%; 95% CI, 18.1-31.5), cesarean section (62.6, 95% CI 57.6-67.3), and preterm delivery was 43.1% (95% CI, 38.7-47.6). Mean gestational age was 34.9 weeks, and mean birth weight was 2470 g. The 2-3-year interval following kidney transplant had higher neonatal mortality, and lower rates of live births as compared to > 3 year, and < 2-year interval. The rate of spontaneous abortion was higher in women with mean maternal age < 25 years and > 35 years as compared to women aged 25-34 years. CONCLUSION: Although the outcome of live births is favorable, the risks of maternal and fetal complications are high in kidney transplant recipients and should be considered in patient counseling and clinical decision making.

The Impact of Patient Characteristics and Postoperative Opioid Exposure on Prolonged Postoperative Opioid Use: An Integrative Review.

OBJECTIVES: The United States is experiencing an opioid overdose crisis. Research suggests prolonged postoperative opioid use, a common complication following surgery, is associated with opioid misuse, which, in turn, is the greatest risk factor of heroin misuse. The objective of this review is to evaluate how postoperative opioid exposure relates to prolonged use and to identify factors that predict prolonged postoperative opioid use. DESIGN: An integrative review of the literature. DATA SOURCES: Electronic and hand searching methods were used in PubMed, Embase, Cochrane Database of Systematic Reviews, Cochrane Central Register of Controlled Trials, CINAHL, and SCOPUS. Search terms included opioid, opiate, postoperative pain, drug administration, prescribing pattern, prescription, inappropriate prescribing, self-medication, patient-controlled analgesia, opioid-naïve patients, and prolonged opioid use. REVIEW/ANALYSIS METHODS: Data were synthesized by identifying themes reflecting the results of the review. A quality assessment of the articles was also conducted. RESULTS: Fourteen articles were included and two main themes emerged: (1) Surgery places opioid naïve patients at risk for prolonged opioid use and (2) Certain patient characteristics may be predictive of prolonged postoperative opioid use. CONCLUSIONS: Prolonged postoperative opioid use is related to factors in addition to prescribing practices. Researchers consistently found that patients who are already on opioids, benzodiazepines, or addicted to alcohol; who have mental health disorders, depressive symptoms, or a self-perceived risk of addiction; and patients with multiple co-morbidities are at greater risk of prolonged use; demographics were inconsistent. NURSING IMPLICATIONS: Studies are needed to determine the predicting characteristics of prolonged postoperative opioid use, the type of surgeries that place patients at most risk, and the effect postoperative exposure to opioids has on prolonged use. This information can be used to develop and implement protocols to prevent misuse among high-risk patients.

Women with an avoidant attachment style show attenuated estradiol responses to emotionally intimate stimuli.

The current study examined neuroendocrine processes associated with emotional intimacy in humans. Despite the importance of this aspect of close relationships, emotional intimacy has received much less attention in neuroendocrine research compared to other aspects of close relationships. In this study, participants viewed movie clips depicting an emotionally intimate parent-child interaction or other, non-intimate themes, and we assessed whether depictions of emotional intimacy increased levels of estradiol, a steroid hormone associated with attachment and caregiving processes. We also examined whether estradiol responses were moderated by individual differences in attachment avoidance, or people's discomfort with closeness and intimacy. Our findings revealed that, among single participants, estradiol levels increased in response to the emotionally intimate clip, but this effect was not observed among currently partnered participants. Moreover, the effects of emotional intimacy were moderated by gender and attachment avoidance, such that highly avoidant women showed smaller increases in estradiol after watching the emotionally intimate clip. Women's avoidance was unrelated to estradiol responses in the non-intimate control conditions, however, suggesting that the effects of avoidance were specific to intimate contexts. Taken together, the current findings contribute to our understanding of the biological bases of attachment and caregiving processes. They also highlight the potential role of estradiol in avoidant individuals' regulation of closeness and intimacy.

Theoretically Based Factors Affecting Stroke Family Caregiver Health: An Integrative Review.

Stroke family caregivers often neglect their own health while providing care. Rigorous reviews have focused on stroke caregiver needs and outcomes; however, a comprehensive review of stroke caregiver health is lacking. The purpose of this integrative review was to determine factors associated with stroke family caregiver health. Using a PRISMA flow diagram and Rayyan software, 41 studies were identified published from January 2000 to December 2020. Databases included Cochrane Reviews, Cochrane Trials, PsycINFO, Ovid MEDLINE, PubMed, EBSCOhost MEDLINE, Embase, and CINAHL. Rigorous guidelines were used to critique the 41 articles. Health measures were global in nature, lacking details regarding health promotion activities important to stroke family caregiver health. Common factors associated with caregiver health were depressive symptoms and burden. Further research is needed to design more situation-specific instruments to measure stroke family caregiver health, as well as interventions to reduce depressive symptoms and burden while promoting caregiver health.

Systematic review of interruptions in the emergency department work environment.

OBJECTIVE: The purpose of this systematic review is to describe the operationalization of interruptions measurement and to synthesize the evidence on the causes and consequences of interruptions in the emergency department (ED) work environment. METHODS: This systematic review of studies explores the causes and consequences of interruptions in the ED. Of 2836 abstract/titles screened, 137 full-text articles were reviewed, and 44 articles met inclusion criteria of measuring ED interruptions. RESULTS: All articles reported primary data collection, and most were cohort studies (n = 30, 68%). Conceptual or operational definitions of interruptions were included in 27 articles. Direct observation was the most common approach. In half of the studies, quantitative measures of interruptions in the ED were descriptive only, without measurements of interruptions' consequences. Twenty-two studies evaluated consequences, including workload, delays, satisfaction, and errors. Overall, relationships between ED interruptions and their causes and consequences are primarily derived from direct observation within large academic hospitals using heterogeneous definitions. Collective strengths of interruptions research in the ED include structured methods of naturalistic observation and definitions of interruptions derived from concept analysis. Limitations are conflicting and complex evaluations of consequences attributed to interruptions, including the predominance of descriptive reports characterizing interruptions without direct measurements of consequences. CONCLUSIONS: The use of standardized definitions and measurements in interruptions research could contribute to measuring the impact and influence of interruptions on clinicians' productivity and efficiency as well as patients' outcomes, and thus provide a basis for intervention research.

Sociosexuality moderates the association between testosterone and relationship status in men and women.

Single individuals typically have higher testosterone compared to those who are partnered, suggesting that individual differences in testosterone are associated with mating effort, or people's motivation to find a sexual partner. However, there is less consistent evidence for links between testosterone and sociosexuality, or people's orientation toward uncommitted sexual activity. Based on Penke and Asendorpf's (2008) conceptualization, we propose that a more nuanced measure of sociosexuality may reveal more robust associations with testosterone. In the current study, we assessed relations between three components of sociosexuality--desire, behavior, and attitudes--and endogenous testosterone levels in men and women. We found that partnered status was indeed associated with lower testosterone in both men and women, but only among those who reported more restricted sociosexuality. Partnered men who reported greater desire for uncommitted sexual activity had testosterone levels that were comparable to those of single men; partnered women who reported more frequent uncommitted sexual behavior had testosterone levels that were comparable to those of single women. These findings provide new evidence that people's orientations toward sexual relationships, in combination with their relationship status, are associated with individual differences in testosterone. The current results are also among the first to demonstrate sociosexuality-testosterone associations in both men and women, and they reveal that the nature of these associations varies by gender. Together, these findings highlight the utility of a multifaceted conceptualization of sociosexuality and the implications of this conceptualization for neuroendocrine processes.

Outreach impact study: the case of the Greater Midwest Region.

OBJECTIVES: The purpose of the study was to assess the impact that funding from the National Network of Libraries of Medicine (NN/LM), Greater Midwest Region (GMR), has on member institutions' ability to conduct outreach on behalf of NN/LM. METHODS: The study employed both content analysis and survey methodologies. The final reports from select GMR-funded outreach projects (n = 20) were analyzed based on a set of evaluation criteria. Project principal investigators (n = 13) were then surveyed using the same evaluation criteria. RESULTS: Results indicated that outreach projects supported by GMR funding improved access to biomedical information for professionals and the general public. Barriers to conducting outreach projects included time constraints or commitments, staffing, scheduling and absenteeism, inadequate space, and issues associated with technology (e.g., hardware and software, Internet connectivity and firewall issues, and creation and use of new technologies). CONCLUSIONS: The majority of project principal investigators indicated that their attempts to conduct outreach were successful. Moreover, most noted that outreach had a positive impact on professionals as well as the general public. In general, it seems that negative outcomes, as with most barriers to conducting outreach, can be mitigated by more thorough planning.

Workplace Violence Interventions Used by Home Healthcare Workers: An Integrative Review.

The threat of workplace violence (WPV) is a significant occupational hazard for home healthcare workers (HHCWs). The purpose of this integrative review is to examine WPV interventions used by HHCWs to stay safe while working in the patient's home and community. The methodology used was the integrative review by , which allows for inclusion of experimental and non-experimental research, reflecting the state of the science on interventions used by HHCWs to mitigate and prevent WPV. A total of 17 articles pertained to interventions used by HHCWs. Interventions were further categorized by WPV Type. There are a number of interventions used for Type I and II WPV. However, interventions for Type III WPV are minimal and interventions for Type IV WPV are obsolete. Safety and health training were shown to be significant in increasing HHCWs' confidence and knowledge about WPV prevention. Researchers demonstrated safety and health training are effective in promoting a safe work environment and reducing incidents of WPV. This review begins to fill the gap in the literature on interventions used by HHCWs to mitigate and prevent WPV.

Posttraumatic stress in adolescents with asthma and their parents.

OBJECTIVE: To assess posttraumatic stress (PTS) symptoms in adolescents with and without asthma and their parents and the relationship between PTS symptoms and asthma morbidity. METHOD: Three groups of adolescents (12-18 years) participated: adolescents who had experienced a life-threatening asthma episode (n=49), asthma controls (n=71), and healthy controls (n=80). Adolescents completed the UCLA PTSD Reaction Index, Multidimensional Anxiety Scale for Children, and Reynolds Depression Inventory. Parents completed the Impact of Events Scale-Revised, Brief Symptom Inventory, and Asthma Functional Morbidity Scale. RESULTS: Twenty percent of adolescents with life-threatening asthma met criteria for PTSD compared with 11% of the asthma controls and 8% of the normal controls. Twenty-nine percent of parents of adolescents with life-threatening asthma met criteria for PTSD compared with 14% of parents of asthma controls and 2% of normal controls. Adolescent PTS symptoms accounted for 5% of the variance in functional asthma morbidity even after controlling for disease severity and other anxiety and depressive symptoms (beta=.26). CONCLUSIONS: Adolescents with asthma and their parents, particularly those who have experienced a life-threatening event, have high levels of PTS symptoms that are linked to asthma morbidity. Interventions to improve asthma outcomes should include assessment and treatment of trauma and PTS symptoms.