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Health authorities worldwide address older adults as a risk group for more serious illness and health complications associated with COVID-19, while social gerontologists have warned that addressing older adults as a risk group of COVID-19 bears the risk of reinforcing ageism. This paper empirically explores to what extent older adults perceive themselves as part of a COVID-19 risk group and how these perceptions influence their everyday lives and experiences of age and ageing. This paper draws upon data from a mixed-methods study on older adults' risk perceptions during COVID-19 in Lower Austria, including a representative survey on 521 adults (60+ years) and data from 20 semi-structured interviews. Approximately two-thirds of the respondents consider themselves at risk of COVID-19 and name age, in addition to pre-existing illness, as a contributing factor in this risk perception. Older adults with health constraints, and especially older men, have a higher probability of perceiving risk due to COVID-19. Additionally, older adults report that they experience being 'suddenly seen as old' or 'being put into a box' during the pandemic, which influenced their experiences and images of ageing. Our study provides insights into how perceived COVID-19 risk affects the everyday lives of older adults. Age-based categorisations of risk contribute to a shift in images of age and ageing, drawing on insecurity and risk, rather than successful and active ageing, to conceptualise later life. [ABSTRACT FROM AUTHOR]

College students with disabilities (SWDs) experience elevated rates of sexual violence and intimate partner violence compared with their non-disabled peers. While tailored interventions for these pressing health issues are needed, current research lacks investigation into how SWDs conceptualize relevant key concepts, such as consent and healthy relationships. This descriptive qualitative study explored these concepts through semi-structured interviews with college SWDs (n = 49), 18–24 years old, in Pennsylvania and West Virginia. The results culminated in six rich, descriptive themes addressing: 1) interpersonal and intrapersonal skills necessary for relationship health; 2) normalization of unhealthy treatment by a partner due to manipulation, denial, and love for the partner; 3) how dichotomous definitions of consent interfere with practical application in lived experiences; 4) how active consent can be both facilitated and hindered within the context of a romantic relationship; 5) perceptions that healthcare providers aim to elicit disclosures of abuse rather than initiate a discussion about relationship health; and 6) students' reticence to disclose abuse to healthcare providers due to mistrust and fear over loss of agency. These results contradict historic narratives that SWDs do not have the same sexual and relationship beliefs and experiences as other students and highlight the perspectives of this marginalized population. Implications for campus prevention programming and healthcare practices include incorporating intersections of disability and violence, discussing the nuances of consent and substance use, and creating conversations about relationship health that are transparent, non-judgmental, and include a broad range of types of abuse. [ABSTRACT FROM AUTHOR]

Migrants experience several challenges en route to or in their host country. Current legislation in Russia imposes a permanent ban on international migrants with HIV obtaining a residence permit in Russia. Using qualitative methodology, we conducted semi-structured interviews with 15 international migrants who have lived with HIV in Russia and 12 interviews with healthcare providers in Russia. With the help of Bonnington's temporal framework, the study finds that the HIV-positive status of migrants becomes a biographical event that interrupts their migration cycle, thereby leading to the disruption of their normal life course which results in 'short term planning' and instability. Although most people living with HIV face similar challenges, Russian law concerning international migrants living with HIV worsens their living experience in Russia. International migrants living with HIV further face social exclusion, serious stigma and discrimination. The results show that the country's demand for migrants with HIV to leave the country to reduce the spread of HIV in Russia is counterproductive: it does not mobilise heath-seeking behaviour among migrants. Therefore, such legislation has to be amended to encourage international migrants living with HIV to access adequate HIV services. [ABSTRACT FROM AUTHOR]

Background: Person-centred care (PCC) has been suggested as the preferred model of dementia care in all settings. The EPCentCare study showed that an adapted PCC approach was difficult to implement and had no effect on prescription of antipsychotics in nursing home residents in Germany. This paper reports the qualitative process evaluation to identify facilitators and barriers of the implementation of PCC in German nursing homes from the perspective of participating practice development champions. Methods: Five individual and 14 group interviews were conducted with 66 participants (staff and managers) from 18 nursing homes. The analysis was based on inductive coding to identify factors influencing the PCC implementation process. Identified factors were systematised and structured by mapping them to the four constructs (coherence, cognitive participation, collective action, reflexive monitoring) of the Normalization Process Theory (NPT) as a framework that explains implementation processes. Results: Facilitating implementation factors included among others broadening of the care perspective (coherence), tolerance development within the care team regarding challenging behaviour (cognitive participation), testing new approaches to solutions as a multi-professional team (collective action), and perception of effects of PCC measures (reflexive monitoring). Among the facilitating factors reported in all the NPT constructs, thus affecting the entire implementation process, were the involvement of relatives, multi-professional teamwork and effective collaboration with physicians. Barriers implied uncertainties about the implementation and expectation of a higher workload (coherence), concerns about the feasibility of PCC implementation in terms of human resources (cognitive participation), lack of a person-centred attitude by colleagues or the institution (collective action), and doubts about the effects of PCC (reflexive monitoring). Barriers influencing the entire implementation process comprised insufficient time resources, lack of support, lack of involvement of the multi-professional team, and difficulties regarding communication with the attending physicians. Conclusions: The findings provide a comprehensive and detailed overview of facilitators and barriers structured along the implementation process. Thus, our findings may assist both researchers and clinicians to develop and reflect more efficiently on PCC implementation processes in nursing homes. Trial registration: ClinicalTrials.gov identifier: NCT02295462; November 20, 2014. [ABSTRACT FROM AUTHOR]

To examine how rural municipalities develop services to people with serious mental illness in relation to evidence-based practice and national guidelines. Additional sources of knowledge and strategies used by the municipalities in relation to their development needs were explored as well. Qualitative multiple-case approach, with 43 deep-interviews involving 84 informants representing selected social psychiatric services from 11 sites. National guidelines and evidence-based practices have a limited impact on how rural municipalities develop services to the target group. The municipalities favor other sources of knowledge, including regional networks, pragmatic problem-solving approaches and community-based knowledge. Most of the informants expressed a need for more systematic and evidence-based knowledge in order to meet their clients' needs. A major challenge to improve the utilization of these methods, is to make adaptions to match the rural municipalities' needs and actual resources without risking the quality of these evidence-based services. [ABSTRACT FROM AUTHOR]

Background: Early and severe neuronal loss in the cholinergic basal forebrain is observed in Alzheimer's disease (AD). To date, cholinomimetics play a central role in the symptomatic treatment of AD dementia. Although basic research indicates that a cholinergic deficit is present in AD before dementia, the efficacy of cholinomimetics in mild cognitive impairment (MCI) remains controversial. Predictors of cholinergic impairment could guide individualized therapy.Objective: To investigate if the extent of the cholinergic deficit, measured using positron emission tomography (PET) and the tracer 11C-N-methyl-4-piperidyl acetate (MP4A), could be predicted from the volume of cholinergic basal forebrain nuclei in non-demented AD patients.Methods: Seventeen patients with a high likelihood of MCI due to AD and 18 age-matched cognitively healthy adults underwent MRI-scanning. Basal forebrain volume was assessed using voxel-based morphometry and a cytoarchitectonic atlas of cholinergic nuclei. Cortical acetylcholinesterase (AChE) activity was measured using MP4A-PET.Results: Cortical AChE activity and nucleus basalis of Meynert (Ch4 area) volume were significantly decreased in MCI. The extent of the cholinergic deficit varied considerably across patients. Greater volumes of anterior basal forebrain nuclei (Ch1/2 area) and younger age (Spearman's rho (17)  = -0.596, 95% -CI [-0.905, -0.119] and 0.593, 95% -CI [0.092, 0.863])) were associated with a greater cholinergic deficit.Conclusion: Data suggest that less atrophy of the Ch1/2 area and younger age are associated with a more significant cholinergic deficit in MCI due to AD. Further investigations are warranted to determine if the individual response to cholinomimetics can be inferred from these measures. [ABSTRACT FROM AUTHOR]

Background: Multiple studies focus on the experiences of visiting students from high resource regions that participated in clinical placements in lower resource countries but less focus on the experiences of the educators accompanying students. Aim: The purpose of this study was to explore the experiences of educators during an international clinical placement of nursing students in a country in West Africa. Methods: We implemented a focussed ethnographic design. We purposively sampled educators who accompanied students on an international clinical placement. Data collection from 2018 to 2019 consisted of in‐depth individual interviews. We utilized Roper and Shapira's (2000, 10.4135/9781483328294.) data analysis process, which includes coding keywords, identifying patterns and theorizing. Findings Three themes emerged from the data: rewards in accompanying students, challenges experienced and the need for mentoring and continuous support. Educators found it rewarding to see growth in students, how students developed as global citizens, how students developed critical thinking and problem‐solving skills and create lifelong friendships. Conclusion: Educators who accompany nursing students to international clinical placement experience valuable learning and challenging issues. Educators must navigate, support and advance student learning when on an international placement. It is crucial to have adequate institutional support from both the home and host country. Summary statement: What is already known about this topic? Multiple research studies focus on the experiences of visiting students from high resource regions that participated in clinical placements in lower resource countries but less focus on the experiences of the educators accompanying students.Multiple rewards exist for educators who accompanying students on an international clinical placement.Nurse educators are expected to mentor students and provide continuous support. What this paper adds? The need for continuous contact between the educators and the home faculty is highlighted.Mentoring topics to 'soften' the impact of the challenges experiences by educators are identified; this includes regular debriefing with senior educators at the home and host university.The importance of working with the host during the predeparture period, as well as report on arrival and have regular meetings during the placement to ensure that both the needs of the visiting student group and the host are met, is highlighted. The implications of this paper: (how findings influence or can be used to change policy/practice/research/education) A well‐developed support system and debriefing sessions are necessary for the accompanying faculty member.Research is needed to develop the content of a mentorship model/framework for junior academics that plan to accompany students on international clinical placements to low and middle‐income countries.Additional research is needed on the value of pairing a junior academic with an experienced mentor to answer questions as they arise related to day‐to‐day challenges and student related questions during the international clinical placements. [ABSTRACT FROM AUTHOR]

Heroin overdose is a leading cause of mortality among drug users. This paper aims to identify individual and contextual factors associated with lethal and non-lethal heroin-related overdoses on the basis of case reports and semi-structured proxy interviews. Typical patterns within these cases are determined by means of cluster analysis. Within the CaRe (Case Reports of heroin-related overdoses) study, case reports (100 proxy reports of overdose events from 36 different facilities) were gathered and evaluated as part of a nationwide survey of experts conducted in Germany in 2019. Following initial descriptive analyses a two-step cluster analysis with the four binary variables of gender, age, time and place was conducted to identify patterns within the reported cases. The case reports grouped into five clusters: 1) Younger male drug users, found in a public space during the daytime; 2) Female drug users; 3) Older male drug users, found in a public space during the daytime; 4) Drug users found at home at night; 5) Drug users found outside at night. Overdoses by female drug users and those which occurred at home and/or at night were significantly more likely to have a fatal outcome. Future prevention and intervention measures should aim to consider the context, i.e. typical constellations of risk, and attempt to inhibit this through appropriate counter measures. [ABSTRACT FROM AUTHOR]

Background: The ability for independent bipedal locomotion is an important prerequisite for autonomous mobility and participation in everyday life. Walking requires not only a functional musculoskeletal unit but relies on coordinated activation of muscles and may even require cognitive resources. The time-resolved monitoring of the position of joints, feet, legs and other body segments relative to each other alone or in combination with simultaneous recording of ground reaction forces and concurrent measurement of electrical muscle activity, using surface electromyography, are well-established tools for the objective assessment of gait.Research Question: The Gait Real-time Analysis Interactive Lab (GRAIL) has been introduced for gait analysis in a highly standardized and well-controlled virtual environment. However, apart from high computing capacity and sophisticated software required to run the system, handling of GRAIL data is challenging due to the utilization of different software packages resulting in a huge amount of data stored using different file formats and different sampling rates. These issues make gait analysis even with such a sophisticated instrument rather tedious, especially within the frame of an experimental or clinical study.Methods: A user-friendly Matlab based toolset for automated processing of motion capturing data recorded using the GRAIL, with the inherent option for batch analysis was developed.Results: The toolset allows the reading, resampling, filtering and synchronization of data stored in different input files recorded with the GRAIL. It includes a coordinate-based algorithm for the detection of initial contact and toe-off events to split and normalize data relative to gait cycles. Batch processing of multiple measurements and automatic detection of outliers is possible.Significance: The authors hope that the toolset will be useful to the research community and invite everyone to use, modify or implement it in their own work. [ABSTRACT FROM AUTHOR]

Objective: To determine whether vaginal progesterone for programmed endometrial preparation is noninferior to intramuscular progesterone in terms of live birth rates from frozen embryo transfer (FET).Design: Three-armed, randomized, controlled noninferiority trial.Setting: Multicenter fertility clinic.Patient(s): A total of 1,346 volunteer subjects planning vitrified-warmed transfer of high-quality nonbiopsied blastocysts were screened, of whom 1,125 subjects were ultimately enrolled and randomly assigned to treatment.Intervention(s): The subjects were randomly assigned to receive, in preparation for FET, 50 mg daily of intramuscular progesterone (control group), 200 mg twice daily of vaginal micronized progesterone plus 50 mg of intramuscular progesterone every third day (combination treatment), or 200 mg twice daily of vaginal micronized progesterone.Main Outcome Measure(s): The primary outcome was live birth rate per vitrified-warmed embryo transfer. The secondary outcomes were a positive serum human chorionic gonadotropin test 2 weeks after FET, biochemical pregnancy loss, clinical pregnancy, clinical pregnancy loss, total pregnancy loss, serum luteal progesterone concentration 2 weeks after FET, and patient's experience and attitudes regarding the route of progesterone administration, on the basis of a survey administered to the subjects between FET and pregnancy test.Result(s): A total of 1,060 FETs were completed. The live birth rate was significantly lower in women receiving only vaginal progesterone (27%) than in women receiving intramuscular progesterone (44%) or combination treatment (46%). Fifty percent of pregnancies in women receiving only vaginal progesterone ended in miscarriage.Conclusion(s): The live birth rate after vaginal-only progesterone replacement was significantly reduced, due primarily to an increased rate of miscarriage. Vaginal progesterone supplemented with intramuscular progesterone every third day was noninferior to daily intramuscular progesterone, offering an effective alternative regimen with fewer injections.Clinical Trial Registration Number: NCT02254577. [ABSTRACT FROM AUTHOR]

Introduction: Empirical evidence on Ronald Inglehart's theory of value change shows that subsequent generations show a decline in values of physical and economic security (materialism) in favor of an increase in values of self-expression and autonomy (postmaterialism).Methods: We investigate in a pre-registered study whether Inglehart's theory also applies to partnership, such that millennials think less that they need a partner to be happy. We used data from the German Socio-Economic Panel (SOEP) study on 4540 17-year-olds from 16 birth cohorts.Results: Results show that adolescents' estimated importance of a romantic partner for personal happiness decreases on average with each subsequent birth cohort. Further significant predictors were socialization and relationship status of the parents, birth year of the father, as well as education and sex of the adolescent. Socioeconomic status and education level of the parents and birth year of the mother were not significant.Conclusions: Findings provide initial evidence that as society becomes more individualized, even personal happiness is increasingly seen as independent of significant others. Ronald Inglehart's theory of value change, however, seems to have only limited applicability as an explanatory model for this development. [ABSTRACT FROM AUTHOR]

Students with disabilities are one student group with elevated risk of sexual violence. Although they would benefit from streamlined access to campus support, little is known about their patterns of campus service use. This qualitative analysis includes data from semi-structured interviews with 51 students with disabilities who experienced sexual violence focused on service use across campus. The resultant conceptual model shows that greater accessibility is associated with positive experiences, and lower accessibility is associated with negative experiences. Students with disabilities who experienced or expected negative reactions (e.g., judgment) were less likely to use services and were less satisfied. Advocacy and support in connecting students with disability or sexual violence services was associated with positive experiences and increased accessibility. These findings highlight key facilitators and barriers to campus service use for students with disabilities with sexual violence histories and suggest key intervention points for increasing accessibility, reducing stigma, and improving student experiences with campus providers, staff, and faculty. [ABSTRACT FROM AUTHOR]

Background: To date, it remains unclear how amyloid plaques and neurofibrillary tangles are related to neural activation and, consequently, cognition in Alzheimer's disease (AD). Recent findings indicate that tau accumulation may drive hippocampal hyperactivity in cognitively normal aging, but it remains to be elucidated how tau accumulation is related to neural activation in AD.Objective: To determine whether the association between tau accumulation and hippocampal hyperactivation persists in mild cognitive impairment (MCI) and mild dementia or if the two measures dissociate with disease progression, we investigated the relationship between local tau deposits and memory-related neural activation in MCI and mild dementia due to AD.Methods: Fifteen patients with MCI or mild dementia due to AD underwent a neuropsychological assessment and performed an item memory task during functional magnetic resonance imaging. Cerebral tau accumulation was assessed using positron emission tomography and [18F]-AV-1451.Results: Entorhinal, but not global tau accumulation, was highly correlated with hippocampal activation due to visual item memory encoding and predicted memory loss over time. Neural activation in the posterior cingulate cortex and the fusiform gyrus was not significantly correlated with tau accumulation.Conclusion: These findings extend previous observations in cognitively normal aging, demonstrating that entorhinal tau continues to be closely associated with hippocampal hyperactivity and memory performance in MCI and mild dementia due to AD. Furthermore, data suggest that this association is strongest in medial temporal lobe structures. In summary, our data provide novel insights into the relationship of tau accumulation to neural activation and memory in AD. [ABSTRACT FROM AUTHOR]

Organisations are subject to ongoing changes. These changes offer opportunities but they can also increase the uncertainty about the future of jobs. Although there is a large body of literature on job insecurity, most studies focus on the worry of losing the job while another important stressor, namely the worry of losing valued job features, received less attention. The key contribution of this validation study is the development and psychometric analysis of the Qualitative Job Insecurity Measure (QJIM) that tries to account for the shortcomings of existing qualitative job insecurity scales. It is a quick but still comprehensive measurement of a highly prevalent but understudied phenomenon that directly influences organisational and employee well-being. The psychometric results show the confirmation of the scale's one-dimensional structure via EFA and CFA, good reliability estimates and the demonstration of the scale's predictive validity regarding job satisfaction and disinclination to work. From a research perspective, QJIM can be used to gain insights into how and when changes negatively affect employees and to identify preventive or corrective measures. From an organisational perspective, QJIM is useful to recognise job features that employees value, to carefully plan changes and to actively increase employee well-being. [ABSTRACT FROM AUTHOR]

Aim: Current guidelines suggest the use of epinephrine in patients with cardiac arrest (CA). However, evidence for increased survival in good neurological condition is lacking. In experimental settings, epinephrine-induced impairment of microvascular flow was shown. The aim of our study was to analyze the association between epinephrine treatment and intestinal injury in patients after CA.Methods: We have included 52 patients with return of spontaneous circulation (ROSC) after CA admitted to our medical intensive care unit (ICU). Blood was taken on admission and levels of circulating intestinal fatty acid binding protein (iFABP) were analyzed.Results: Patients were 64 (49.8-73.8) years old and predominantly male (76.9%). After six months, 50% of patients died and 38.5% of patients had a cerebral performance category (CPC)-score of 1-2. iFABP levels were lower in survivors (234 IQR 90-399 pg/mL) as compared to non-survivors (283, IQR 86-11500 pg/mL; p < 0.05). Plasma levels of iFABP were not associated with time to ROSC but correlated with epinephrine-dose (R = 0.32; p < 0.05). 40% of patients receiving ≥3 mg of epinephrine as compared to 10.5% of patients treated with <3 mg (p < 0.05) developed iFABP plasma levels >1500 pg/mL, which was associated with dramatically increased mortality (HR4.87, 95%CI 1.95-12.1; p < 0.001). iFABP levels predicted mortality independent from time to ROSC and the disease severity score SAPS II. In contrast to mortality, iFABP plasma levels were not associated with neurological outcome.Conclusions: In this small, single centre study, cumulative dose of epinephrine used in cardiac arrest patients was associated with an increase in biomarker indicative of intestinal injury and 6-month mortality. [ABSTRACT FROM AUTHOR]

Objective: To evaluate characteristics associated with treatment failure 1 year after midurethral sling in women with mixed urinary incontinence.Methods: Four hundred three women who participated in a randomized trial that compared midurethral sling and behavioral and pelvic floor muscle therapy (combined group) against midurethral sling alone for mixed incontinence with 1 year of follow-up data were eligible for this planned secondary analysis. Overall treatment failure was defined as meeting criteria for subjective failure, objective failure, or both. Subjective failure was defined as not meeting the minimal clinically important difference for improvement on the UDI (Urogenital Distress Inventory)-total score (26.1 points). Objective failure was not achieving 70% improvement on mean incontinence episodes of any type per day or having undergone any additional treatment for urinary symptoms at 12 months postoperative. Logistic regression models for treatment failure were constructed. Independent variables included site and treatment group, and clinical and demographic variables based on bivariate comparisons (P<.2). Treatment group interaction effects were evaluated.Results: Previous overactive bladder medication use (unadjusted odds ratio [OR] 2.19, adjusted odds ratio [aOR] 1.89, 95% CI 1.10-3.25), detrusor overactivity on cystometrogram (OR 2.25, aOR 2.72, 95% CI 1.53-4.84), body mass index (OR 1.29, aOR 1.27, 95% CI 1.03-1.57), and Valsalva leak point pressure less than 60 cm H2O (OR 1.96, aOR 3.13, 95% CI 1.65-5.94) were associated with overall failure. Worse UDI urgency scores were associated with failure in the midurethral sling-alone group. Sling type (retropubic vs transobturator) was not associated with failure.Conclusion: Certain clinical and urodynamic variables are associated with treatment failure after midurethral sling among women with mixed urinary incontinence. Women with more severe urgency symptoms at baseline may benefit from perioperative behavioral and pelvic floor muscle therapy combined with midurethral sling. This information is helpful for counseling women with mixed incontinence who are considering surgery.Clinical Trial Registration: ClinicalTrials.gov, NCT01959347. [ABSTRACT FROM AUTHOR]

Background: Extracorporeal photopheresis (ECP) is an immunosuppressive treatment that involves leukocyte apheresis, psoralen and UV light treatment, and subsequent reinfusion. Patients treated with ECP are usually immunosuppressed. Bacterial contamination therefore poses a much unwanted risk, but incidence data are lacking.Patients and Methods: We screened all 1922 consecutive ECP procedures scheduled within a roughly 3-year period for eligibility. Those with missing data on ECP method (inline or offline) or type of venous access (peripheral or central) were excluded. ECPs with complete aerobic and anaerobic microbial testing of baseline patient blood samples (n = 1637) and of ECP cell concentrates (n = 1814) were included in the analysis.Results: A test for microbial contamination was positive for 1.82% of the cell concentrates, with central venous access was the most significant risk factor for the contamination (odds ratio = 19). Patient blood samples were positive in 3.85% of cases, but no patients became septic. Staphylococcus spp. were most abundant, and products with bacterial contamination did not cause side effects after reinfusion. There were no significant differences in contamination rates between inline and offline ECP.Conclusion: These findings stress the importance of sterile procedures and the benefits of using peripheral over central venous access for reducing the risk of bacterial contamination in ECP. [ABSTRACT FROM AUTHOR]

Objective: To determine the pharmacokinetics (PK) of drospirenone (DRSP), alone versus in combination with ethinyl estradiol (EE), after single and repeated administration.Study Design: We conducted a single-centre, open-label, crossover, 2-treatment, 2-period, 2-sequence study in which non-micronized DRSP 4 mg or a combination of DRSP 3 mg and EE 0.02 mg were administered to healthy female subjects on day 1 to obtain a single-dose kinetic profile, and from day 4 to day 15 to obtain a repeated-dose kinetic profile. The maximum observed concentration (Cmax) and area under the concentration/time curve (AUC) were determined in a model-independent way using non dose corrected data. Statistical analysis was based on a parametric method (ANOVA-log).Results: A total of 24 healthy female subjects were randomized 1:1 into the study. The mean relative, non-dose-corrected PK estimates after single-dose administration for the endpoints AUC(0-72h), AUC(0-24h) and Cmax were 543.5 ng*h/mL, 296.1 ng*h/mL and 27.3 ng/mL for DRSP alone, and 442.0 ng*h/mL, 264.7 ng*h/mL and 37.5 ng/mL for the DRSP/EE combination; p < 0.001. The mean relative, non-dose-corrected PK estimates after repeated dose administration for the endpoints AUC(0-72h), AUC(0-24h) and Cmax were 1066.8 ng*h/ml, 570.2 ng*h/mL and 41.0 ng/mL for DRSP alone, and 1394.5 ng*h/mL, 732.8 ng*h/mL and 61.4 ng/mL for the DRSP/EE combination; p < 0.001.Conclusions: DRSP alone exhibits a lower accumulation ratio than together with EE. The extent of systemic exposure at steady-state is about 32% less with the new formulation (AUC(0-24h), steady-state geometric mean ratio: 77.8%; 90% confidence interval: 74.6%-81.1%). This PK profile may be caused by EE.Implications: Our results suggest that metabolic pathways of DRSP can be inhibited by EE resulting in higher DRSP plasma concentrations in DRSP/EE formulations than in a DRSP-alone formulation. The enzymes CYP3A4 and SULT1A1 may play a role. Additional drug-drug-interaction studies are needed to better understand these metabolic pathways and their future clinical implications. [ABSTRACT FROM AUTHOR]

OBJECTIVES: We examined demographic characteristics and birth outcomes of infants with neonatal abstinence syndrome (NAS) and their mothers in Canada. METHODS: This retrospective, population-based, descriptive cross-sectional study of mother-infant dyads included all singleton live births in Canada (excluding Quebec), from 2005-2006 to 2015-2016 (N = 2 881 789). Demographic characteristics, NAS, and neonatal and maternal morbidities were identified from delivery hospitalization data (including diagnostic codes). The main composite outcomes were maternal and neonatal mortality and/or severe morbidity, including death and potentially life-threatening conditions in the mother and the infant, respectively. Logistic regression yielded adjusted odds ratios (aORs) and 95% confidence intervals (CIs). RESULTS: The study included 10 027 mother-infant dyads with NAS. The incidence of NAS increased from 0.20% to 0.51%. Maternal mortality was 1.99 vs 0.31 per 10 000 women in the NAS group versus the comparison group (aOR = 6.53; 95% CI: 1.59 to 26.74), and maternal mortality and/or severe morbidity rates were 3.10% vs 1.35% (aOR = 2.21; 95% CI: 1.97 to 2.49). Neonatal mortality was 0.12% vs 0.19% (aOR = 0.28; 95% CI: 0.15 to 0.53), and neonatal mortality and/or severe morbidity rates were 6.36% vs 1.73% (aOR = 2.27; 95% CI: 2.06 to 2.50) among infants with NAS versus without NAS. CONCLUSIONS: NAS incidence increased notably in Canada between 2005--2006 and 2015--2016. Infants with NAS had elevated severe morbidity, and their mothers had elevated mortality and severe morbidity. These results highlight the importance of implementing integrated care services to support the mother-infant dyad during childbirth and in the postpartum period. [ABSTRACT FROM AUTHOR]

Background: In 2001, the International Classification of Functioning and Disability (ICF) introduced participation as a main goal of rehabilitation processes. However, to date, a comprehensive concept of participation in the rehabilitative context is missing, particularly in German‐speaking countries. We thus aimed to refine and extend the existing concepts of participation in this brief communication. Methods: In preceding studies, we conducted semi‐structured interviews with adolescents who either had chronic diseases and/or physical disabilities or had no impairments and focus groups with parents and experts. Based on these diverse perspectives and findings, we refine the term participation. Results: Participation is a construct that is embedded in a social context and consists of objective (i.e., attendance) and subjective (i.e., satisfaction and involvement) dimensions. These dimensions are reflected in different domains and areas that are relevant to adolescents' lives. In addition, the subjective relevance of respective areas in life needs to be regarded as a weighing component when evaluating participation. Conclusion: Our results reflect international models on participation, refine the existing concept, and underline the multidimensional character of participation. These findings are urgently needed to develop appropriate instruments, for example, for assessing whether rehabilitative processes are effective regarding the goal of participation. [ABSTRACT FROM AUTHOR]

Objective: To explore antecedents and outcomes of nurse self-reported job satisfaction and dissatisfaction-based turnover cognitions, theorizing (using Self-Determination Theory) that leaders can foster work conditions that help fulfill innate needs, thereby fostering satisfaction of nurses and patients, and reducing adverse events.Data Sources/study Setting: Primary and secondary data were collected within a 4-month period in 2015, from 2,596 nurses in 110 Army treatment facilities (hospitals and clinics) across 35 health care systems.Data Collection/extraction: We collected individual nurse responses to the Practice Environment Scale-Nursing Work Index, in addition to aggregated archival data from the same timeframe, including both facility-level patient satisfaction records (the Army Provider Level Satisfaction Survey) and health care system-level adverse events records (provided by the Army Programming, Analysis, and Evaluation office).Principal Findings: Five predictors of nurse satisfaction and turnover cognitions emerged-supportive leadership, staffing levels, nurse-physician teamwork, adoption of nursing care practice, and advancement opportunities. Aggregated nurse satisfaction was the most consistent predictor of both patient satisfaction and adverse events.Conclusion: These findings provide evidence of the importance of nurse attitudes in improving perceived and actual performance across facilities and health care systems; in addition to practical steps, managers can take to improve satisfaction and retention. [ABSTRACT FROM AUTHOR]

Background: Early growth faltering accounts for one-third of child deaths, and adversely impacts the health and human capital of surviving children. Social as well as biological factors contribute to growth faltering, but their relative strength and interrelations in different contexts have not been fully described.Objective: The aim of this study was to use structural equation modelling to explore social and biological multidetermination of child height at age 2 y in longitudinal data from 4 birth cohort studies in low- and middle-income countries.Methods: We analyzed data from 13,824 participants in birth cohort studies in Brazil, India, the Philippines, and South Africa. We used exploratory structural equation models, with height-for-age at 24 mo as the outcome to derive factors, and path analysis to estimate relations among a wide set of social and biological variables common to the 4 sites.Results: The prevalence of stunting at 24 mo ranged from 14.0% in Brazil to 67.7% in the Philippines. Maternal height and birthweight were strongly predictive of height-for-age at 24 mo in all 4 sites (all P values <0.001). Three social-environmental factors, which we characterized as "child circumstances," "family socioeconomic status," and "community facilities," were identified in all sites. Each social-environmental factor was also strongly predictive of height-for-age at 24 mo (all P values <0.001), with some relations partly mediated through birthweight. The biological pathways accounted for 59% of the total explained variance and the social-environmental pathways accounted for 41%. The resulting path coefficients were broadly similar across the 4 sites.Conclusions: Early child growth faltering is determined by both biological and social factors. Maternal height, itself a marker of intergenerational deprivation, strongly influences child height at 2 y, including indirect effects through birthweight and social factors. However, concurrent social factors, many of which are modifiable, directly and indirectly contribute to child growth. This study highlights opportunities for interventions that address both biological and social determinants over the long and short term. [ABSTRACT FROM AUTHOR]

Objective: Participation is one of the key goals of re/habilitative processes. Since participation impacts adolescents' social–emotional development and overall health, this goal is particularly important for them. However, to date, no German‐speaking self‐assessment tool for participation among adolescents is available. This study sought therefore to develop such a tool and to test its psychometric properties. Methods: Based on a preliminary qualitative study, we developed 133 items for a pilot version of the Social Participation Inventory (SPI). The SPI assesses the objective dimension (i.e., attendance) and the subjective dimension (i.e., involvement and satisfaction) of participation. To test the psychometric properties of the SPI, we conducted a quantitative cross‐sectional survey and applied the SPI to n = 151 adolescents with and without disabilities and/or chronic diseases. Results: By using principal component analyses, we examined the SPI's consistency and verified the theoretical considerations regarding the two components of participation (i.e., objective and subjective dimensions). Items that did not load sufficiently on components were removed after careful theoretical‐based consideration. The condensed version of the SPI consists of 39 items that assess participation and 18 items to assess the perceived importance of respective areas of life. The SPI shows very good overall reliability (Cronbach's α =.920) and good validity. Conclusion: This study provides a new psychometrically tested participation self‐assessment scale for adolescence with and without disabilities and/or chronic diseases. Further research is needed to re‐evaluate its psychometric properties and to evaluate the application of the SPI in clinical and scientific contexts. [ABSTRACT FROM AUTHOR]

Background: Tyrosine kinase inhibitors (TKIs) have improved the survival of patients with chronic myeloid leukaemia. Many patients have deep molecular responses, a prerequisite for TKI therapy discontinuation. We aimed to define precise conditions for stopping treatment.Methods: In this prospective, non-randomised trial, we enrolled patients with chronic myeloid leukaemia at 61 European centres in 11 countries. Eligible patients had chronic-phase chronic myeloid leukaemia, had received any TKI for at least 3 years (without treatment failure according to European LeukemiaNet [ELN] recommendations), and had a confirmed deep molecular response for at least 1 year. The primary endpoint was molecular relapse-free survival, defined by loss of major molecular response (MMR; >0·1% BCR-ABL1 on the International Scale) and assessed in all patients with at least one molecular result. Secondary endpoints were a prognostic analysis of factors affecting maintenance of MMR at 6 months in learning and validation samples and the cost impact of stopping TKI therapy. We considered loss of haematological response, progress to accelerated-phase chronic myeloid leukaemia, or blast crisis as serious adverse events. This study presents the results of the prespecified interim analysis, which was done after the 6-month molecular relapse-free survival status was known for 200 patients. The study is ongoing and is registered with ClinicalTrials.gov, number NCT01596114.Findings: Between May 30, 2012, and Dec 3, 2014, we assessed 868 patients with chronic myeloid leukaemia for eligibility, of whom 758 were enrolled. Median follow-up of the 755 patients evaluable for molecular response was 27 months (IQR 21-34). Molecular relapse-free survival for these patients was 61% (95% CI 57-64) at 6 months and 50% (46-54) at 24 months. Of these 755 patients, 371 (49%) lost MMR after TKI discontinuation, four (1%) died while in MMR for reasons unrelated to chronic myeloid leukaemia (myocardial infarction, lung cancer, renal cancer, and heart failure), and 13 (2%) restarted TKI therapy while in MMR. A further six (1%) patients died in chronic-phase chronic myeloid leukaemia after loss of MMR and re-initiation of TKI therapy for reasons unrelated to chronic myeloid leukaemia, and two (<1%) patients lost MMR despite restarting TKI therapy. In the prognostic analysis in 405 patients who received imatinib as first-line treatment (learning sample), longer treatment duration (odds ratio [OR] per year 1·14 [95% CI 1·05-1·23]; p=0·0010) and longer deep molecular response durations (1·13 [1·04-1·23]; p=0·0032) were associated with increasing probability of MMR maintenance at 6 months. The OR for deep molecular response duration was replicated in the validation sample consisting of 171 patients treated with any TKI as first-line treatment, although the association was not significant (1·13 [0·98-1·29]; p=0·08). TKI discontinuation was associated with substantial cost savings (an estimated €22 million). No serious adverse events were reported.Interpretation: Patients with chronic myeloid leukaemia who have achieved deep molecular responses have good molecular relapse-free survival. Such patients should be considered for TKI discontinuation, particularly those who have been in deep molecular response for a long time. Stopping treatment could spare patients from treatment-induced side-effects and reduce health expenditure.Funding: ELN Foundation and France National Cancer Institute. [ABSTRACT FROM AUTHOR]

Objectives: to apprehend the perceptions of women who experience the climacteric. Methodology: descriptive exploratory study with a qualitative approach, carried out at the Basic Health Unit of a municipality in the Northwest of Paraná. Data were collected through a semistructured interview with 16 women in December 2016 and submitted to content analysis, thematic modality. Results: the perceptions of women experiencing climacteric resulted in two categories: experiencing climacteric and menopause: signs and symptoms; and Treatment used in climacteric. It was observed the direct influence of signs and symptoms on the quality of life of these women and often the search for hormone replacement due to ignorance. Conclusion: the reception and integral care of the woman should be part of the routine of care of the professionals, especially of the Basic Attention, providing the knowledge of the particular needs and the planning of care actions. [ABSTRACT FROM AUTHOR]

Objective: To assess the noninferiority of vaginal P (Endometrin) compared with daily intramuscular P for replacement in programmed vitrified-warmed blastocyst transfer cycles and to assess the noninferiority of vaginal P in combination with intramuscular progesterone every third day compared with daily intramuscular P.Design: Three-arm randomized controlled noninferiority study. To enable early recognition of inferiority if present, an a priori interim analysis was planned and completed once ongoing pregnancy data were available for 50% of the total enrollment goal. The results of this interim analysis are presented here.Setting: Assisted reproduction technology practice.Patient(s): Women undergoing transfer of nonbiopsied high quality vitrified-warmed blastocyst(s) in a programmed cycle.Intervention(s): Vitrified-warmed blastocyst transfer with mode of P replacement determined by randomization to either: (1) 50 mg daily intramuscular P only; (2) 200 mg twice daily vaginal Endometrin; or (3) 200 mg twice daily Endometrin plus 50 mg intramuscular P every 3rd day.Main Outcome Measure(s): Live birth. The primary outcome of this interim analysis was ongoing pregnancy.Result(s): A total of 645 cycles were randomly assigned to one of the three treatment arms, received at least one dose of P replacement therapy according to this assignment and underwent vitrified-warmed blastocyst transfer. These cycles were included in the intention-to-treat analysis. The study team, including the statistician, were blinded to the identity of the treatment arms, which were randomly labeled "A," "B," and "C" in the dataset. Ongoing pregnancy occurred in 50%, 47%, and 31% of cycles in arms A, B, and C respectively. Although arm C had an rate of positive hCG equivalent to the other two arms, the rate of pregnancy loss for arm C was significantly higher than for either of the two arms, resulting in a more than one-third lower rate of ongoing pregnancy. There were no statistically significant differences for any outcome tested between arms A and B. Results of a per-protocol analysis were nearly identical to those of the intention-to-treat analysis. On completion of these analyses, arm C was revealed to be the vaginal P only arm.Conclusion(s): Relative to regimens inclusive of intramuscular P, vaginal-only P replacement for vitrified-warmed blastocyst transfer results in decreased ongoing pregnancy, due to increased miscarriage, and should be avoided. Randomization to the vaginal-only arm was terminated with these findings. This trial is ongoing to assess the noninferiority of the vaginal plus every 3rd day intramuscular P arm compared with daily intramuscular P in terms of live birth.Clinical Trial Registration Number: NLM identifier NCT02254577. [ABSTRACT FROM AUTHOR]

Purpose: To determine the accuracy of particle range prediction for proton and heavier ion radiation therapy based on dual-energy computed tomography (DECT) in a realistic inhomogeneous geometry and to compare it with the state-of-the-art clinical approach.Methods and Materials: A 3-dimensional ground-truth map of stopping-power ratios (SPRs) was created for an anthropomorphic head phantom by assigning measured SPR values to segmented structures in a high-resolution CT scan. This reference map was validated independently comparing proton transmission measurements with Monte Carlo transport simulations. Two DECT-based methods for direct SPR prediction via the Bethe formula (DirectSPR) and 2 established approaches based on Hounsfield look-up tables (HLUTs) were chosen for evaluation. The SPR predictions from the 4 investigated methods were compared with the reference, using material-specific voxel statistics and 2-dimensional gamma analysis. Furthermore, range deviations were analyzed in an exemplary proton treatment plan.Results: The established reference SPR map was successfully validated for the discrimination of SPR and range differences well below 0.3% and 1 mm, respectively, even in complex inhomogeneous settings. For the phantom materials of larger volume (mainly brain, soft tissue), the investigated methods were overall able to predict SPR within 1% median deviation. The DirectSPR methods generally performed better than the HLUT approaches. For smaller phantom parts (such as cortical bone, air cavities), all methods were affected by image smoothing, leading to considerable SPR under- or overestimation. This effect was superimposed on the general SPR prediction accuracy in the exemplary treatment plan.Conclusions: DirectSPR predictions proved to be more robust, with high accuracy in particular for larger volumes. In contrast, HLUT approaches exhibited a fortuitous component. The evaluation of accuracy in a realistic phantom with validated ground-truth SPR represents a crucial step toward possible clinical application of DECT-based SPR prediction methods. [ABSTRACT FROM AUTHOR]

Objective: To assess the relationship between diminished ovarian reserve and pregnancy outcomes in a large cohort of women achieving pregnancy through in vitro fertilization (IVF). We evaluated antral follicle count (AFC) and baseline FSH as a measure of ovarian reserve. Secondarily, we assessed whether diminished ovarian reserve was associated with aneuploidy among spontaneous abortions.Design: Retrospective cohort study.Setting: Multicenter private practice.Patient(s): All patients aged 21-44 years undergoing fresh autologous IVF cycles during 2009-2013 that resulted in positive serum hCG with recorded baseline FSH levels.Intervention(s): None.Main Outcome Measure(s): Live births per early pregnancy, biochemical pregnancies, clinical pregnancy losses, and aneuploidy rates in products of conception among pregnancy losses.Result(s): A total of 9,489 cycles among 8,214 patients were analyzed. There was no association between live birth and ovarian reserve among pregnant IVF patients under the age of 35 years. Among patients 35 years of age and older, elevated baseline FSH was associated with a higher risk of pregnancy loss, which increased with increasing age. AFC was not significantly associated with pregnancy loss at any age. No associations were found between ovarian reserve measures and aneuploidy in products of conception in age-adjusted analyses, although the power to effectively evaluate this was limited.Conclusion(s): Diminished ovarian reserve is not associated with an increase in miscarriage among younger women achieving pregnancy through IVF. Elevated FSH is associated with a higher risk of IVF pregnancy loss among older patients. We found no evidence to confirm that diminished ovarian reserve is associated with increased aneuploidy among spontaneous abortions. [ABSTRACT FROM AUTHOR]

Heavy college drinking is associated with risky sexual behavior. It is therefore important to identify groups that are especially vulnerable to alcohol-influenced sexual risk (e.g., unplanned/unexpected sex). Undergraduates with elevated social anxiety represent one such vulnerable group given that social anxiety is associated with fear of intimacy and heavier drinking in intimate situations and situations with expected negative affect. Drinking to cope with negative affect induced by fear of intimacy might render socially anxious undergraduates vulnerable to risky sexual behavior, yet no known studies have examined this relationship. The current study tested whether social anxiety was related to alcohol-related sexual behaviors among current (past-month) drinking undergraduates (88.1% female; 77.6% non-Hispanic Caucasian) with higher (i.e., clinically elevated) social anxiety (HSA;n = 40) or lower (more normative) social anxiety (LSA;n = 94). Coping motives were examined as a moderator of the social anxiety-risky sexual behavior relationship. Gender was a covariate. HSA students reported more frequent alcohol-influenced sexual risk including regretted sexual situations, unprotected sex, sex with unwanted partners, unwanted sex, pressured/forced to have sex, and pressured someone to have sex. Coping motives significantly interacted with social anxiety group in the prediction of risky sexual behaviors except regretted sexual situations, such that HSA students with greater coping motives experienced more frequent sexual risk when drinking. Findings indicate that HSA students may be particularly vulnerable to risky sexual behaviors and suggest that coping motivated drinking may be an important target for therapeutic interventions geared toward reducing risky sexual behaviors among this high-risk population. [ABSTRACT FROM PUBLISHER]

Rationale: Increased attention to cancer care has instigated altered systems for screening, diagnosis, and management of various types of cancer, such as in the prostate. While such systems very likely have improved the quality of cancer care, they also result in the altered use of specific services, such as magnetic resonance imaging (MRI). Aims and Objective: To study the change in the use of prostate MRI in the Norwegian health care system from 2013 to 2021 and to investigate some reasons for and potential implications of this change. Method: Data from the Norwegian Health Economics Administration (HELFO), The Cancer Registry of Norway and Cause‐of‐death registry at the Norwegian Institute of public health and the health registry of Vestfold Hospital Trust were used for descriptive statistical analysis. Results: The number of MRIs of the prostate increased threefold from 2013 to 2021, representing an extra cost of 2 million USD in 2020. The incidence of prostate cancer was stable at about 5000 cases per year, corresponding to 178 per 100,000 men, indicating no increased overdiagnosis. However, the clinical staging has changed substantially during this period, indicating stage and grade migration. The number of negative biopsies was reduced, and there are three MRIs per reduced negative biopsy. The number of persons on active surveillance increased during the period. However, these changes are partly independent of the increase in the number of MRIs. Conclusion: There was a substantial increase in the number of prostate MRIs and thus an increase in costs. This appears to have contributed to the reduction of negative biopsies, improved staging and increased active surveillance. However, as these effects are partly independent of the increase in MRIs, we need to document the outcomes for patients from prostate MRIs as their opportunity costs are substantial. [ABSTRACT FROM AUTHOR]

Purpose: This is the first study to evaluate the long-term effectiveness of a school-based prevention program in Germany. The aim is to determine the long-term effects of the primary prevention program PriMa (Primary prevention of anorexia nervosa in preadolescent girls) on disordered eating and body self-esteem from childhood to young adulthood.Methods: PriMa was conducted and successfully evaluated in a quasi-experimental pre-post design with a control group from 2007 to 2008 consisting of 11-13year old girls (N=1508) from Thuringian schools in Germany. Seven to eight years after the intervention, the same cohort (mean age 19.8years) was invited to complete an online survey. Disordered eating (EAT-26), body self-esteem (FBeK) and BMI were assessed via self-report. The response rate at seven-to-eight-year follow-up was very low (7%). Data of N=100 girls were analyzed.Results: Concerning changes in disordered eating, results revealed no significant long-term effect of PriMa seven to eight years after the intervention. During this time, disordered eating remained stable without a significant increase or decrease. Regarding changes in body self-esteem, group courses differed significantly from each other. The results revealed a significant main effect of group, indicating significant differences in changes of body self-esteem between the intervention and the control group. Following the analysis of these changes of body self-esteem over time, it was found that the intervention group revealed an increase of body self-esteem after program participation and remained stable over time. By contrast, the control group revealed a decrease of body self-esteem over time.Conclusions: Long-term intervention effects of PriMa could be found for body self-esteem but not for disordered eating. The findings suggest that PriMa prevented a decrease of body self-esteem from childhood to young adulthood. For a broader dissemination it is necessary to implement prevention programs consistently in school settings. In order to maintain the prevention effects, it would be interesting to investigate the effects of booster sessions which refresh the programs content on a regular basis. Furthermore, the results of this study revealed the implementation difficulties of primary prevention programs especially concerning the retention of the sample size. [ABSTRACT FROM AUTHOR]

The Child Feeding Questionnaire (CFQ) is a self-report questionnaire for assessing parental attitudes to child weight and parental feeding practices. Previous evaluations of its psychometric properties were conducted primarily with small to medium-sized samples (N < 500) and a small range of children's age. The present study aims to analyze the psychometric properties of the CFQ in a large German community sample and, for the first time, to establish normative data. Within the population-based LIFE Child study, the CFQ was administered to N = 982 mothers of 2- to 13-year-old children. Psychometric analyses on item statistics and internal consistency were conducted. Using structural equation modeling, four empirically-based factorial models of the CFQ were evaluated, and measurement invariance across child age groups and sex was examined. Age-specific norms for the CFQ subscales were computed. Item statistics were highly favorable for the majority of items, but floor and ceiling effects were found for 14 of 31 items. Internal consistency of the CFQ subscales ranged from acceptable to excellent (0.71 ≤ α ≤ 0.91), except for the subscale Perceived Responsibility (α = 0.65). Regarding factorial validity, an eight-factor model with the newly created Reward subscale provided the best fit to the data. This model was factorial invariant across child sex and adjacent age groups. Maternal and child weight status showed large effects on CFQ subscale scores. The analyses established good psychometric properties for the German version of the CFQ and confirmed an eight-factor model. The provided norms allow for the comparison of individual parental feeding practices and change over time. The CFQ's sensitivity to change and longitudinal associations of parental feeding practices and child weight status warrant further research. [ABSTRACT FROM AUTHOR]

Importance: Women with refractory urgency urinary incontinence are treated with sacral neuromodulation and onabotulinumtoxinA with limited comparative information.Objective: To assess whether onabotulinumtoxinA is superior to sacral neuromodulation in controlling refractory episodes of urgency urinary incontinence.Design, Setting, and Participants: Multicenter open-label randomized trial (February 2012-January 2015) at 9 US medical centers involving 381 women with refractory urgency urinary incontinence.Interventions: Cystoscopic intradetrusor injection of 200 U of onabotulinumtoxinA (n = 192) or sacral neuromodulation (n = 189).Main Outcomes and Measures: Primary outcome, change from baseline mean number of daily urgency urinary incontinence episodes over 6 months, was measured with monthly 3-day diaries. Secondary outcomes included change from baseline in urinary symptom scores in the Overactive Bladder Questionnaire Short Form (SF); range, 0-100, higher scores indicating worse symptoms; Overactive Bladder Satisfaction questionnaire; range, 0-100; includes 5 subscales, higher scores indicating better satisfaction; and adverse events.Results: Of the 364 women (mean [SD] age, 63.0 [11.6] years) in the intention-to-treat population, 190 women in the onabotulinumtoxinA group had a greater reduction in 6-month mean number of episodes of urgency incontinence per day than did the 174 in the sacral neuromodulation group (-3.9 vs -3.3 episodes per day; mean difference, 0.63; 95% CI, 0.13 to 1.14; P = .01). Participants treated with onabotulinumtoxinA showed greater improvement in the Overactive Bladder Questionnaire SF for symptom bother (-46.7 vs -38.6; mean difference, 8.1; 95% CI, 3.0 to 13.3; P = .002); treatment satisfaction (67.7 vs 59.8; mean difference, 7.8; 95% CI, 1.6 to 14.1; P = .01) and treatment endorsement (78.1 vs 67.6; mean difference; 10.4, 95% CI, 4.3 to 16.5; P < .001) than treatment with sacral neuromodulation. There were no differences in convenience (67.6 vs 70.2; mean difference, -2.5; 95% CI, -8.1 to 3.0; P = .36), adverse effects (88.4 vs 85.1; mean difference, 3.3; 95% CI, -1.9 to 8.5; P = .22), and treatment preference (92.% vs 89%; risk difference, -3%; 95% CI, -16% to 10%; P = .49). Urinary tract infections were more frequent in the onabotulinumtoxinA group (35% vs 11%; risk difference, -23%; 95% CI, -33% to -13%; P < .001). The need for self-catheterization was 8% and 2% at 1 and 6 months in the onabotulinumtoxinA group. Neuromodulation device revisions and removals occurred in 3%.Conclusions and Relevance: Among women with refractory urgency urinary incontinence, treatment with onabotulinumtoxinA compared with sacral neuromodulation resulted in a small daily improvement in episodes that although statistically significant is of uncertain clinical importance. In addition, it resulted in a higher risk of urinary tract infections and need for transient self-catheterizations. [ABSTRACT FROM AUTHOR]

Introduction: Few hospitals treat patients' tobacco dependence. To be effective, hospital-initiated cessation interventions must provide at least 1 month of supportive contact post-discharge.Study Design: Individually randomized clinical trial. Recruitment commenced July 2011; analyses were conducted October 2014-June 2015.Setting/participants: The study was conducted in two large Midwestern hospitals. Participants included smokers who were aged ≥18 years, planned to stay quit after discharge, and spoke English or Spanish.Intervention: Hospital-based cessation counselors delivered the intervention. For patients randomized to warm handoff, staff immediately called the quitline from the bedside and handed the phone to participants for enrollment and counseling. Participants randomized to fax were referred on the day of hospital discharge.Main Outcome Measures: Outcomes at 6 months included quitline enrollment/adherence, medication use, biochemically verified cessation, and cost effectiveness.Results: Significantly more warm handoff than fax participants enrolled in quitline (99.6% vs 59.6%; relative risk, 1.67; 95% CI=1.65, 1.68). One in four (25.4% warm handoff, 25.3% fax) were verified to be abstinent at 6-month follow-up; this did not differ significantly between groups (relative risk, 1.02; 95% CI=0.82, 1.24). Cessation medication use in the hospital and receipt of a prescription for medication at discharge did not differ between groups; however, significantly more fax participants reported using cessation medication post-discharge (32% vs 25%, p=0.01). The average incremental cost-effectiveness ratio of enrolling participants into warm handoff was $0.14. Hospital-borne costs were significantly lower in warm handoff than in fax ($5.77 vs $9.41, p<0.001).Conclusions: One in four inpatient smokers referred to quitline by either method were abstinent at 6 months post-discharge. Among motivated smokers, fax referral and warm handoff are efficient and comparatively effective ways to link smokers with evidence-based care. For hospitals, warm handoff is a less expensive and more effective method for enrolling smokers in quitline services. [ABSTRACT FROM AUTHOR]

Background: Leadership is a key feature in implementation efforts, which is highlighted in most implementation frameworks. However, in studying leadership and implementation, only few studies rely on established leadership theory, which makes it difficult to draw conclusions regarding what kinds of leadership managers should perform and under what circumstances. In industrial and organizational psychology, transformational leadership and contingent reward have been identified as effective leadership styles for facilitating change processes, and these styles map well onto the behaviors identified in implementation research. However, it has been questioned whether these general leadership styles are sufficient to foster specific results; it has therefore been suggested that the leadership should be specific to the domain of interest, e.g., implementation. To this end, an intervention specifically involving leadership, which we call implementation leadership, is developed and tested in this project. The aim of the intervention is to increase healthcare managers' generic implementation leadership skills, which they can use for any implementation efforts in the future.Methods/design: The intervention is conducted in healthcare in Stockholm County, Sweden, where first- and second-line managers were invited to participate. Two intervention groups are included, including 52 managers. Intervention group 1 consists of individual managers, and group 2 of managers from one division. A control group of 39 managers is additionally included. The intervention consists of five half-day workshops aiming at increasing the managers' implementation leadership, which is the primary outcome of this intervention. The intervention will be evaluated through a mixed-methods approach. A pre- and post-design applying questionnaires at three time points (pre-, directly after the intervention, and 6 months post-intervention) will be used, in addition to process evaluation questionnaires related to each workshop. In addition, interviews will be conducted over time to evaluate the intervention.Discussion: The proposed intervention represents a novel contribution to the implementation literature, being the first to focus on strengthening healthcare managers' generic skills in implementation leadership. [ABSTRACT FROM AUTHOR]

Objective: To analyze auditory nerve recovery function (REC), comparing the results after local anesthesia and sedation with those after general anesthesia.Methods: This was a prospective, cross-sectional and descriptive study in a tertiary referral center hospital. We included all patients (37 ears) who underwent surgery for cochlear implant under either general anesthesia or local anesthesia and sedation during 3 years. REC was measured according to the function of 3 components, 'T0', 'A' and 'tau', and was taken for 3 cochlear electrodes (apical, medial and basal).Results: There were no significant differences in 'tau' and in the current level used, but there were significant differences in the parameters 'T0' apical and 'A' basal.Conclusions: There were no significant differences in REC between the 2 types of anesthesia, except for the parameters 'T0' apical and 'A' basal. [ABSTRACT FROM AUTHOR]

Isolated chondral and osteochondral defects of the knee are challenging clinical entities, particularly in younger patients. Cartilage treatment strategies have previously been characterized as palliation (ie, chondroplasty and debridement), repair (ie, drilling and microfracture), or restoration (ie, autologous chondrocyte implantation, osteochondral autograft, and osteochondral allograft). The osteochondral autograft transplantation procedure allows defects to be filled immediately with mature, hyaline articular cartilage by utilizing either an arthroscopic or a mini-open procedure. Graft harvest and placement can be technically demanding, but results show trends toward greater longevity, durability, and improved outcomes in high-demand patients when compared with alternative techniques. Improved results are shown in younger patients with isolated lesions between 1 and 4 cm. [ABSTRACT FROM AUTHOR]

Background: The aim of this study was to quantify the variability in spinal radiosurgery (SRS) planning practices between five international institutions, all member of the Elekta Spine Radiosurgery Research Consortium.Methods: Four institutions provided one representative patient case each consisting of the medical history, CT and MR imaging. A step-wise planning approach was used where, after each planning step a consensus was generated that formed the basis for the next planning step. This allowed independent analysis of all planning steps of CT-MR image registration, GTV definition, CTV definition, PTV definition and SRS treatment planning. In addition, each institution generated one additional SRS plan for each case based on intra-institutional image registration and contouring, independent of consensus results.Results: Averaged over the four cases, image registration variability ranged between translational 1.1 mm and 2.4 mm and rotational 1.1° and 2.0° in all three directions. GTV delineation variability was 1.5 mm in axial and 1.6 mm in longitudinal direction averaged for the four cases. CTV delineation variability was 0.8 mm in axial and 1.2 mm in longitudinal direction. CTV-to-PTV margins ranged between 0 mm and 2 mm according to institutional protocol. Delineation variability was 1 mm in axial directions for the spinal cord. Average PTV coverage for a single fraction18 Gy prescription was 87 ± 5 %; Dmin to the PTV was 7.5 ± 1.8 Gy averaged over all cases and institutions. Average Dmax to the PRV_SC (spinal cord + 1 mm) was 10.5 ± 1.6 Gy and the average Paddick conformity index was 0.69 ± 0.06.Conclusions: Results of this study reflect the variability in current practice of spine radiosurgery in large and highly experienced academic centers. Despite close methodical agreement in the daily workflow, clinically significant variability in all steps of the treatment planning process was demonstrated. This may translate into differences in patient clinical outcome and highlights the need for consensus and established delineation and planning criteria. [ABSTRACT FROM AUTHOR]

Background: At the time of initial diagnosis, only 15-20% of patients with pancreatic cancer present with a resectable disease. Patients with pancreatic cancer face a poor prognosis. Progression-free survival and overall survival rates are very limited, so it is important to develop concepts to improve the quality of life for their remaining lives.Methods/design: The proposed trial is a randomized controlled intervention study. After pancreatic resection, the intervention group (cohort A, n = 30 patients) will take part in an intensified physiotherapy program consisting of endurance and muscle force exercises. The control group (cohort B, n = 30 patients) will take part in standard physiotherapy. Both groups will receive dietary counseling and, if necessary, substitution for endocrine/exocrine pancreatic insufficiency. Quality of life will be evaluated using the Short Form-8 Health Survey and the European Organization for Research and Treatment of Cancer QLQ-C30/QLQ-PAN26 questionnaires.Discussion: The aim of this study is to investigate whether intensive physiotherapy improves the quality of life of patients after pancreatic resection. If the results for the intervention group are positive, a multicenter study should be performed with appropriate statistical power. The progressive postresection program includes a structured follow-up after pancreatic resection. In this study, all patients will undergo abdominal computed tomography for follow-up 6 and 12 months postoperatively.Trial Registration: German Clinical Trials Register DRKS00006786. Date of registration 1 October 2014. [ABSTRACT FROM AUTHOR]

Background: Charcot osteo-neuroarthropathy (CN) of the foot can induce severe instability and deformity. Results of a consecutive clinical multi-centre study with Midfoot Fusion Bolt (MFB, Synthes GmbH, Oberdorf, Switzerland) are reported.Methods: All patients (aged 18 years and older) treated between 2009 and 2013 with surgical reconstruction of the midfoot with MFB for CN were included. Demographics, pre-surgical health status, details of foot pathology, details of surgery, postoperative treatment, treatment failure, and adverse events were registered. The following radiographic angles were measured on pre-op, post-op and last follow-up radiographs: talo-1st metatarsal (TMT) angle dorsoplantar and lateral view, and calcaneo-5th metatarsal angle.Results: Forty-seven patients (48 feet) were included in three centres. In 38 patients (80.1%) diabetes was diagnosed. Wound healing problems occurred in 21% of patients and recurrent ulceration in 13%. Revision surgery for loss of correction was performed in three cases (6%). Union rate at final follow-up was 98%. Major amputation for deep infection was performed in two patients (4%), minor amputation at the foot level in three cases (6%). Failure was more frequent when only one MFB (instead of 2 or 3) was used and no Gastrocnemius lengthening was performed. Radiographic alignment significantly improved pre- versus postoperatively and preoperatively versus follow-up.Conclusions: Realignment and fixation with MFB in severe CN result in adequate correction with minimal loss of correction in the observed clinical course. The non-union rate was lower than previously reported. Stable fixation with MFB is a valuable treatment option for CN with minimal loss of correction and high union rates. The use of a minimum of two bolts is recommended to avoid recurrent deformity. Clinical Trials.gov: NCT01770639. [ABSTRACT FROM AUTHOR]

As federal partners, the Veterans Health Administration (VA) and the Indian Health Service (IHS) agreed to share resources, such as education. The VA Geriatric Scholars Program, a workforce development program, provides one of its training programs on team-based primary care of elders to clinicians working in IHS and Tribal Health Programs. The practical impact of that training is described. A mixed methods approach was applied to the course's evaluation survey at five clinics in the Northwestern Plains, Southwest, Pacific Coast, and Alaska. Quantitative approaches assessed participants' self-reported intention to improve recognition and assessment of common geriatric syndromes. A qualitative approach applied to open-ended text responses revealed intensions to improve team-based care. Among the 51 respondents in our sample, we found significant improvements in self-reported ability to recognize previously unfamiliar potential risks to elders' health and safety, t(49) = 8.0233, p <.001, as well as increased comfort with conducting geriatric assessments and increased confidence in interprofessional team-based communication. Improvements to team-based care included enhanced clinical skills, organizational factors and the need to train additional employees. This evaluation demonstrates the value of sharing resources among federal partners and its value for participants in IHS and Tribal Health Programs. [ABSTRACT FROM AUTHOR]

CONTEXT: The relationship of national laws that prohibit child marriage with the prevalence of child marriage and adolescent birth is not well understood. METHODS: Data from Demographic and Health Surveys and from the Child Marriage Database created by the MACHEquity program at McGill University were used to examine the relationship between laws that consistently set the age for marriage for girls at 18 or older and the prevalence of child marriage and teenage childbearing in 12 Sub-Saharan African countries. Countries were considered to have consistent laws against child marriage if they required females to be 18 or older to marry, to marry with parental consent and to consent to sex. Associations between consistent laws and the two outcomes were identified using multivariate regression models. RESULTS: Four of the 12 countries had laws that consistently set the minimum age for marriage at 18 or older. After adjustment for covariates, the prevalence of child marriage was 40% lower in countries with consistent laws against child marriage than in countries without consistent laws against the practice (prevalence ratio, 0.6). The prevalence of teenage childbearing was 25% lower in countries with consistent minimum marriage age laws than in countries without consistent laws (0.8). CONCLUSION: Our results support the hypothesis that consistent minimum marriage age laws protect against the exploitation of girls. [ABSTRACT FROM AUTHOR]

AimThe aim of this study is to investigate factors contributing to the failure of a randomized clinical trial designed to implement and test clinical practice guidelines for the treatment of depression in primary health care (PHC).BackgroundAlthough the occurrence of depression is increasing globally, many patients with depression do not receive optimal treatment. Clinical practice guidelines for the treatment of depression, which aim to establish evidence-based clinical practice in health care, are often underused and in need of operationalization in and adaptation to clinical praxis. This study explores a failed clinical trial designed to implement and test treatment of depression in PHC in Sweden.MethodQualitative case study methodology was used. Semi-structured interviews were conducted with eight participants from the clinical trial researcher group and 11 health care professionals at five PHC units. Additionally, archival data (ie, documents, email correspondence, reports on the clinical trial) from the years 2007–2010 were analysed.FindingsThe study identified barriers to the implementation of the clinical trial in the project characteristics, the medical professionals, the patients, and the social network, as well as in the organizational, economic and political context. The project increased staff workload and created tension as the PHC culture and the research activities clashed (eg, because of the systematic use of questionnaires and changes in scheduling and planning of patient visits). Furthermore, there was a perception that the PHC units’ management did not sufficiently support the project and that the project lacked basic incentives for reaching a sustainable resolution. Despite efforts by the project managers to enhance and support implementation of the innovation, they were unable to overcome these barriers. The study illustrates the complexity and barriers of performing clinical trials in the PHC. [ABSTRACT FROM PUBLISHER]

When used effectively, social media benefits hospitals through increased revenue, employee recruitment, and increased customer satisfaction. Although 72% of adults who use the Internet engage in social media, little is known about its prevalence among hospitals and the ways in which hospitals use it. We examined hospital characteristics associated with social media use and how U.S. hospitals use Facebook. Through analysis of websites and Facebook pages, we found that seven in 10 hospitals use social media and that 9% of hospitals with a Facebook page do not provide a link to it from their web page. The odds of social media use were greater in large, urban, nonprofit hospitals; at hospitals affiliated with universities or health systems; and at hospitals that emphasize quality metrics or educational information. Hospitals use Facebook as a dissemination strategy to educate consumers, acknowledge staff, and share news of the hospital's awards. However, the majority of hospitals do not actively engage consumers on Facebook pages. We conclude that this lack of engagement is a lost opportunity to enhance customer service, improve quality of care, and build loyalty. For hospital executives, we illustrate that Facebook is underutilized and that considerable opportunity exists for consumer engagement at a low cost. For policymakers, there is a greater use of social media by nonprofit hospitals, compared to for-profit facilities. As Facebook is most commonly used as an educational tool, it is another example of nonprofit hospitals' heightened focus on health promotion and disease prevention. [ABSTRACT FROM AUTHOR]

The threat of tuberculosis (TB) in Uganda cannot be considered in isolation from the HIV/AIDS epidemic. Stigma contributes to delays in seeking treatment and poor adherence for both TB and HIV patients. This study aims to assess and describe stigma and predictors of stigma related to TB and HIV in the population of western Uganda. This was a cross-sectional mixed methods study. A survey was administered to 360 individuals, randomly selected from one district in western Uganda. Participants were classified as low/high stigma based on weighted scores built from survey questions. Logistic regression was used to determine significant predictors for high stigma. Six focus groups were conducted to inform survey findings; themes were developed using content analysis. Twenty-six per cent of respondents were found to have stigmatising attitudes towards HIV and 47% towards TB. Multivariate logistic regression models included age, sex, marital status, education, residence and having a friend with HIV/TB. Those who had an HIV-positive friend were less likely to have high HIV stigma (OR: 0.41, 95% CI: 0.23–0.72). Those with secondary education or more were half as likely to have high TB stigma (OR: 0.50, 95% CI: 0.27–0.91). Focus group participants felt that “normalisation” of HIV has contributed to reduced HIV stigma, but there is still a fear of being recognised at the HIV clinic. TB stigma causes patients to remain silent instead of seeking care. Fear of TB is driven by the assumption that “TB means HIV”. Declining HIV stigma is encouraging but more effort needs to be made to improve confidentiality. TB stigma is high and is likely affecting care seeking behaviour; TB awareness campaigns should be a priority and emphasise the treatability and curability of TB, regardless of HIV status. [ABSTRACT FROM PUBLISHER]

Objective: To describe the effectiveness of investigating and treating the cause of refractory chest pain in patients with coronary artery disease who are receiving optimal antianginal therapy.Design: Cohort study.Setting: Tertiary referral center.Patients: Between January 1988 and December 1989, 34 patients were identified as having angiographically proven coronary artery disease and atypical chest pain symptoms despite their having received aggressive medical or surgical antianginal therapy, or both.Intervention: Patients with confirmed acid-related symptoms were treated with high-dose histamine-2 (H2) blockers or omeprazole for 8 weeks in an open-label study.Measurements: Esophageal manometry and simultaneous 24-hour pH and Holter studies; global improvement in or disappearance of chest pain.Results: Of the 34 patients, 30 (88%) experienced their identical chest pain symptoms during the study. A total of 164 pain episodes was recorded: 38 (23.2%) correlated with acid reflux; 6 (3.7%) were related to cardiac ischemia; and the remaining 120 (73.2%) had no identifiable cause. Of these 30 patients, 20 (67%) had some of their episodes of chest pain (range, 14% to 100%) secondary to acid reflux. After 8 weeks of vigorous acid suppression, 13 of these 20 patients had marked improvement or resolution of chest pain. Four other patients had ischemia-related episodes of chest pain that responded to more aggressive antianginal therapy. No episodes of acid reflux were clearly followed by ischemic chest pain. One patient had both acid- and ischemic-related episodes of chest pain that were indistinguishable. Overall, 24 of 34 (71%) patients had a definite cause of chest pain identified by combined pH and Holter monitoring.Conclusions: Gastroesophageal reflux disease is a common, treatable cause of chest pain in patients with coronary artery disease who have atypical symptoms and remain symptomatic despite aggressive antianginal therapy. Combined Holter and 24-hour esophageal pH studies are complementary investigations for elucidating the cause of chest pain in these patients. [ABSTRACT FROM AUTHOR]

After high-speed machining of rolled and stretch straightened aluminium sheets, out-of-plane distortion is found. This is especially true for complex machined shapes in thin-gauge and high-strength aluminium alloys. This kind of sheets are mostly found in the aeronautical industry, where thin-weight-optimised aluminium shell designs are used for skin applications. Usually, in the aeronautical sector, low-thickness sections are used wherever possible, and higher thicknesses are used only where additional strength is required. In the present work, a methodology of predicting workpiece distortion based on the residual stress present in the workpiece is presented, which can be applied by machining companies without further investment in measurement equipment. A method for accurately determining through-the-thickness residual stresses was adapted to the special requirements of this industrial sector. The measured residual stresses were used in a finite element model capable of approximately calculating the shape distortion of simple and complex high-speed machined parts. Promising results have been obtained. [ABSTRACT FROM AUTHOR]

Using qualitative data from Project SIZE—a study that explores child and family well-being in the context of HIV/AIDS and poverty, we interviewed the female caregivers of 20 9- to 10-year-old children and 16 of the father-figures nominated by children. We consider how childhood experiences with fathers are associated with women's expectations and men's experiences of fathering. Data were analysed thematically in pairs of the focal child's caregiver and father-figure. Data from four women who were not paired were analysed individually. Results generally support both the modelling and the compensatory hypotheses to explain intergenerational influences on men's fathering attitudes and behaviour. Our results go a step further to acknowledge that fatherhood is dynamic and, in rural KwaZulu-Natal, it is influenced also by socio-cultural and economic factors, societal expectations, father-mother relationship and individual characteristics of men. [ABSTRACT FROM AUTHOR]

This study investigated key principal leadership skills associated with socially proactive school environments and examined the relationship between School-Wide Positive Behavior Support (SWPBS) implementation and increased evidence of those skills. Findings indicated the following: (a) certified staff members and principals from all schools rated the importance of each of the 31 skills as high; (b) principals in SWPBS schools received significantly higher ratings associated with behavior management effectiveness; and (c) principals from SWPBS and non-PBS schools received relatively equivalent ratings in regard to transformational and managerial skills. SWPBS-certified staff respondents indicated statistically significantly greater rates of job satisfaction than did those in non-PBS schools. Implications for future research are discussed. [ABSTRACT FROM PUBLISHER]

Background: There have been several attempts to systematically assess performance in bronchoscopy. Earlier validation studies have used bronchoscopy simulators, not real-life performance in patients. Objectives: The aim of this study was to explore the reliability and validity of an assessment tool aimed for the use in a clinical setting. Methods: Five junior residents, 5 senior residents and 9 consultants performed 3 bronchoscopies each. All 57 bronchoscopies were video-recorded and assessed blindly and independently by two bronchoscopy experts using the new assessment tool. Results: The interrater reliability was high, with Cronbach's α = 0.86. Assessment of 3 bronchoscopies by a single rater had a generalizability coefficient of 0.84. The correlation between experience and performance was good (Pearson correlation = 0.76). There were significant differences between the groups for all aspects of the assessment, but post hoc tests showed different discriminative abilities. Conclusions: This new tool for assessing clinical bronchoscopy performance has a high interrater reliability. One rater assessing performance of 3 bronchoscopies ensures sufficient reliability. The assessment tool demonstrated sufficient construct validity. Copyright © 2011 S. Karger AG, Basel [ABSTRACT FROM AUTHOR]