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Bipolar disorder affects around 2% of the population and is linked with reduced life expectancy and socioeconomic burden. Depressive episodes are difficult to treat and typically more prevalent, enduring and burdensome than manic episodes. The use of antidepressants alone has limited effect and is associated with significant clinical risk through polarity switch. Current National Institute for Health and Care Excellence guidelines recommend quetiapine, olanzapine (with or without fluoxetine) and lamotrigine; however, these medications have limited efficacy, tolerability and acceptability. The ASCEnD study aims to assess the clinical and cost-effectiveness of aripiprazole plus sertraline compared with quetiapine, offering potential improvements for outcomes in bipolar depression. The study is funded by the National Institute for Health and Care Research Health Technology Assessment programme (NIHR132773).
ASCEnD is a prospective, two-arm, superiority, individually 1:1 randomised, controlled, pragmatic, parallel group, type A open-label clinical trial of aripiprazole/sertraline medication combination compared with quetiapine for bipolar depression. The study is conducted in the UK National Health Service setting with the aim of recruiting and randomising 270 participants followed-up for 24 weeks. Adults with bipolar disorder self-refer or are recruited through primary and secondary care services. The primary outcome is change in depressive symptoms 12–16 weeks after randomisation. Secondary outcomes include measures of symptom change, treatment satisfaction, tolerability, medication adherence, concomitant medication use, psychosocial functioning, quality of life and cost-effectiveness and informal carer measures of quality of life and costs of caring. The exploratory outcome is change in participant reward and punishment responsiveness. Analysis will follow a prespecified statistical analysis plan. A nested qualitative study is included to examine feasibility and acceptability of the trial design.
A Clinical Trial Authorisation from Medicines and Healthcare products Regulatory Agency, and approval from the Health Research Authority (IRAS 1007468) and North East – Newcastle and North Tyneside 1 Research Ethics Committee (23/NE/0132) were obtained. Results will be disseminated through peer-reviewed publications, conference presentations and lay summaries for participants and patient and public groups.
To determine common and distinct factors experienced by nurses working in acute care settings during the second year of the COVID-19 pandemic.
An online qualitative descriptive study with eight open-ended questions and a comprehensive demographic profile administered via the Qualtrics XM survey software.
Thirteen countries formed teams and led online data collection in their respective countries through various approaches. The data collection period occurred between January 1, 2021, and February 28, 2022. Descriptive thematic analysis was conducted in English (with translation), Spanish, and Korean to analyse the qualitative data. Descriptive statistics summarised the responses to the demographic profile.
Worldwide, a final sample size of n = 1814 produced 6483 qualitative data points for analysis. The results identified ongoing occupational risk factors for nurses during the pandemic's second year, including mental health issues, yet showed some improvements in access to personal protective equipment and resources. Four themes emerged from the qualitative analysis, highlighting role changes, living states, and insights into the implementation of pandemic response measures.
Despite individual occupational risks nurses described, structural factors associated with healthcare delivery produced common nursing experiences during the pandemic. Additionally, at least two distinct stages of pandemic response implementation were demarcated by treatment availability (e.g., vaccine development).
There is potential for common pandemic response policies for nurses, centered on specific factors, such as the increased provision of mental health support services by healthcare organisations.
This study helped determine the common and distinct work experiences during the second year of the COVID-19 pandemic. Nurses simultaneously experienced increased workload, role changes, perpetual fear and fatigue, daily hostility, and chaos in the implementation of pandemic responses. The results will impact nurses and those they serve along with future pandemic response policies.
We have adhered to the SRQR reporting guidelines.
This study did not include patient or public involvement in its design, conduct, or reporting.
Idiopathic pulmonary fibrosis (IPF), an unknown aetiology type of interstitial lung disease (ILD), carries the poorest prognosis and is more common in males and the elderly. Gender differences in baseline presentation, lung function and comorbidities may have an impact on prognostic outcomes.
The aim of this study was to explore gender differences in clinical features, comorbidities and outcomes in IPF in a UK cohort.
This was a retrospective cohort study analysing data from the British Thoracic Society UK IPF ILD Registry from January 2013 to February 2024. We compared baseline characteristics between males and females, and a survival analysis in both genders was performed using the Cox proportional hazards model.
We identified 6666 IPF patients with a mean age at diagnosis of 74.1±8.1. Our cohort was predominantly male (5197, 78%), with a higher proportion of current and ex-smokers compared with females (69.9% vs 59.9%, p
Gender differences in baseline characteristics and prognostic factors were observed in IPF. A gender-based approach in managing IPF is warranted, and further studies are needed to clarify these differences and their impact on IPF management.
Patients receiving haemodialysis are at very high risk of fragility fracture, yet there are no proven treatments for fracture prevention. We will advance a pilot study on the feasibility of a large, pragmatic, randomised controlled trial (RCT) of denosumab for fragility fracture prevention in haemodialysis.
PRevEnting FracturEs in REnal Disease-1 is a pragmatic, open-label, pilot study of an RCT of a denosumab care pathway embedded in routine care haemodialysis centres.
We will recruit at least 60 participants at high risk of fracture from at least 6 haemodialysis centres in Ontario, Canada. They must be aged 40 years or older, have access to provincial drug coverage, have appropriate baseline calcium and parathyroid hormone levels and be deemed suitable for denosumab by their kidney care provider. Participants will be randomised 1:1 to denosumab (with supports to mitigate hypocalcaemia) versus usual care using block randomisation by a central statistician (computer-generated sequence). Primary outcomes include recruitment feasibility and adherence. Secondary outcomes include safety (hypocalcaemia) and participant satisfaction with our protocol and processes. Study investigators and data analysts will be blind to treatment allocation.
We will present results descriptively. The trial was approved by Clinical Trials Ontario and local research ethics boards across study sites.
Primary and secondary outcomes will be published on trial completion.
This pilot will inform the feasibility of conducting a large-scale, efficiently run, pragmatic RCT to test whether a denosumab care pathway safely reduces the risk of fragility fracture in patients receiving haemodialysis. Results have the potential to transform fracture care in real-world patients with kidney and metabolic bone disease.
Variations in mental health and sexual and reproductive health (SRH) outcomes of girls/women (cisgender and transgender) and gender-diverse (nonbinary, Two-Spirit, gender fluid, agender, queer, gender neutral) youth with intersectional identities exist and have largely been ignored in the literature. There is a lack of information on how these health services meet the health needs of girls/women and gender-diverse youth with intersectional identities and the quality of such services. The objective of this global realist review is to identify how, why, for whom, in what contexts and to what extent mental health and SRH services meet the health needs of girls/women (cisgender and transgender) and gender-diverse youth (10–25 years) with intersectional identities.
The protocol has been registered with PROSPERO and will follow Realist and Meta-narrative Evidence Syntheses Quality Standards for Realist Reviews. We will identify the programme theory and implementation determinants of mental health and SRH services for girls/women (cisgender and transgender) and gender-diverse (nonbinary, Two-Spirit, fluid, agender, queer, gender neutral) youth (10–25 years). The scope of the review will be defined in the first stage and will include consultations with youth Advisory Group members and initial programme theory development. An iterative search of scholarly bibliographic databases (MEDLINE, Embase, APA PsycInfo, CINAHL, Web of Science, IBSS) in addition to a grey literature search will take place in the second stage. The third stage will include evidence extraction and synthesis. In the final stage, the narrative will be developed and refined in consultation with Youth Advisory Group members, and findings will be disseminated.
The study was approved by the Research Ethics Board at the Centre for Addiction and Mental Health (2023/153). Findings will be disseminated through peer-reviewed publications, youth-friendly materials and webinars and national and international conferences.
CRD42024532422.
Background
Patients with multiple chronic conditions often have many care plans, polypharmacy, and unrelieved symptoms that contribute to high emergency department and hospital use. High-quality primary care delivered in practices that employ nurse practitioners can help prevent the need for such acute care services. However, such practices located in primary care health professional shortage areas face challenges caring for these patients because of higher workloads and fewer resources.
Objective
We examined differences in hospitalization and emergency department use among patients with multiple chronic conditions who receive care from practices that employ nurse practitioners in health professional shortage areas compared to practices that employ nurse practitioners in non-health professional shortage areas.
Methods
We performed an analysis of Medicare claims, merged with Health Resources and Services Administration data on health professional shortage area status in five states. Our sample included 394,424 community-dwelling Medicare beneficiaries aged ≥65 years, with at least two of 15 common chronic conditions who received care in 779 practices that employ nurse practitioners. We used logistic regression to assess the relationship between health professional shortage area status and emergency department visits or hospitalizations.
Results
We found a higher likelihood of emergency department visits among patients in health professional shortage areas compared to those in non-health professional shortage areas and no difference in the likelihood of hospitalization.
Discussion
Emergency department use differences exist among older adults with multiple chronic conditions receiving care in practices that employ nurse practitioners in health professional shortage areas, compared to those in non-health professional shortage areas. To address this disparity, the health professional shortage area program should invest in recruiting and retaining nurse practitioners to health professional shortage areas to ease workforce shortages. 
FreshRSS 