Conectar
To identify facilitators and barriers to quality, equitable discharge teaching by paediatric emergency department nurses during the COVID-19 pandemic, describe impacts of inequitable discharge teaching, and identify potential solutions to the barriers.
Twenty-two nurses in a single urban paediatric hospital participated in individual interviews from January to April 2022 via phone or videoconference. Interviews were transcribed and analysed using an inductive codebook.
Six barriers to equitable discharge teaching were identified: ED overcrowding, travel nurse training/knowledge, burnout and stress, increased role complexity, COVID precautions, and resource bottlenecks. Two facilitators were also identified: engagement and effective communication. Nurses described the impacts of these barriers along with proposed solutions to improve discharge teaching.
The COVID-19 pandemic created additional barriers to discharge teaching in the paediatric emergency department. Nurses identified barriers and facilitators, the impacts on patients and families, and potential solutions to improve equitable discharge teaching.
This study identifies how periods of high patient volumes or frequent process changes during a pandemic exacerbate inequities in discharge teaching.
This study identifies barriers and facilitators that shaped nurses' ability to provide quality, equitable discharge teaching during the COVID-19 pandemic and offers actionable guidance for hospital leaders and health systems to improve discharge teaching and enhance emergency preparedness for future public health crises.
This study conforms to the Standards for Reporting Qualitative Research.
This study did not include patient or public involvement in its design, conduct, or reporting.
ClinicalTrials.gov identifier: NCT04676490
To determine whether a novel urine collection device (the ‘Pee-in-Pot (PiP)’) produces the same rates of reportable urine culture results as standard of care (SOC) urine collection. To determine whether the PiP produces comparable microscopy results to SOC urine collection. To estimate the carbon footprint of the PiP compared to SOC urine collection.
A prospectively designed, single-centre, paired comparison study.
A district general hospital in Southwest England, including antenatal clinical, accident and emergency, medical and surgical ward environments.
Adults aged 18 or over.
Urine passed through the PiP device before being decanted into a 10 mL boric acid tube for microscopy and culture, compared with the same urine contained only in a sterile plastic vessel before being decanted into a boric acid tube for microscopy and culture.
The proportion of positive urine culture results.
The proportion of heavy mixed growth culture results. Comparison of particle counts: all small particles, bacteria, red blood cells and white blood cells.
Microscopy was performed for 1353 paired samples, of which 808 paired samples both underwent culture. Overall, urine cultures were positive in 9.3% (75/808) and 10.0% (81/808) of PiP and control cases, respectively. Overall matching between PiP and control arms for reportable positive culture results was 98.5% (796/808), with a Cohen’s Kappa test coefficient () of 0.9149 (almost perfect agreement). There was no significant difference in the rate of positive urine culture results between testing arms for any organisms (margin of non-inferiority prospectively defined as ±2.5% for Escherichia coli positive cultures). For microscopy, there was agreement in meeting culture thresholds for 1308 of 1353 paired samples with a difference in culturing rates of 0.00517 (95% CI –0.0045 to 0.015, ie, high level of agreement). The estimated base case carbon footprint of PiP testing was 95g CO2e compared to 270g CO2e for SOC testing.
This study found the PiP to be non-inferior for routine urine microscopy and culture testing and to have a lower carbon footprint compared with SOC urine testing.
To explore the perspectives and experiences of maternity care providers regarding obstetric violence across low-, middle-, and high-income countries.
An integrative review of the literature.
A systematic literature search in CINAHL, Medline (via Ovid), SCOPUS, and the Cochrane Library was conducted from 2014 to 2024. Further papers were identified through a review of the reference lists of identified studies and through email alerts from searched databases. Articles were appraised using the applicable Joanna Briggs Institute qualitative or cross-sectional critical appraisal tool.
Title and abstract screen were undertaken on 2748 records. Fifty-four studies using qualitative, quantitative, and mixed-methods designs were included. Maternity providers across all socio-economic levels described witnessing, and/or involvement in both respectful care and incidents of obstetric violence. The most common forms of obstetric violence were verbal and physical abuse, coercion, unconsented and unnecessary interventions, and violations of privacy and autonomy. Women who were socially marginalised, impoverished, and illiterate were vulnerable to obstetric violence. Differences were noted between low- and high-income countries, with detention of women for non-payment, privacy violations due to building design and lack of space, mistreatment due to HIV status, and women who were considered non-compliant being more vulnerable to obstetric violence in low-and low-middle-income countries. Obstetric violence was justified and normalised in the name of saving the baby, with less focus on the psychological health of the mother.
Our findings demonstrate that obstetric violence is a gender-based violence enabled through patriarchal structures and power imbalances. Maternity providers are witnessing or enacting obstetric violence across low-, middle- and high-income countries, with significant impacts on women and maternity care providers alike. This review highlights opportunities for further research and action to develop health and legal frameworks to prevent instances of obstetric violence and improve outcomes for women and maternity care providers.
A woman-centred approach underpinned by respectful maternity care has benefits for pregnant and birthing women. Obstetric violence, including verbal and physical abuse, coercion, and overmedicalisation, is prevalent in maternity services globally. This integrative review explored the perspectives and experiences of maternity care providers regarding obstetric violence across low-, middle-, and high-income countries. This review highlights the similarities and differences of witnessed, enacted, and perceived obstetric violence from the experience of maternity care providers. This review identifies the covert and overt nature of obstetric violence across low-, middle- and high-income countries. Gaining insight into provider perspectives across low-, middle-, and high-income countries may inform policy and practice reforms to eliminate obstetric violence and advance the provision of respectful maternity care.
This integrative review adheres to the Preferred Reporting Items for Systematic Review and Meta-Analysis (PRISMA) guidelines.
No patient or public contribution.
To estimate the prevalence of potential overtreatment of type 2 diabetes mellitus (T2DM) among older adults and to develop and compare predictive models to identify patient and physician characteristics associated with overtreatment.
Population-based retrospective cohort study with predictive modelling.
A province-wide, publicly funded healthcare system in British Columbia, Canada, using linked administrative health claims data from 2016 to 2023.
Residents of long-term care facilities over age 65, and community-dwelling individuals over age 75, with a diagnosis of T2DM and a glycated haemoglobin (A1C) laboratory value ≤7.0%. Participants were required to have ≥365 days of continuous provincial health insurance coverage prior to their index A1C test. Patients receiving palliative care and those with missing physician information were excluded.
Potential overtreatment of T2DM, defined a priori as overlapping prescriptions for ≥2 glucose-lowering medications or ≥1 insulin or sulfonylurea dispensing within 90 days after the index A1C test.
Model performance outcomes included discrimination (area under the curve (AUC), sensitivity, specificity, positive predictive value and negative predictive value). Performance metrics were calculated with 95% CIs using a 25% temporally distinct test dataset (2021–2023). No changes were made to outcome definitions after protocol development.
Among 133 773 patients with an A1C≤7.0%, 38 074 (28.5%) were classified as overtreated. These patients had a mean age of 79.6 years, were 47% female, and had a median A1C of 6.4%. The gradient boost model was the best performing model overall, using a combination of expert-selected variables and data-driven variables, achieving an AUC of 0.87, sensitivity of 0.81 and negative predictive value of 0.89. The top predictors of overtreatment included use of blood glucose test strips, A1C test volume, polypharmacy, specialist involvement and measures of diabetes severity.
Overtreatment of T2DM was prevalent among older adults in our cohort. Machine learning algorithms that integrate clinical expertise with data-driven variable selection performed the best in predicting T2DM overtreatment. We identified several patient and physician characteristics as key contributors that may inform future clinical practice and quality improvement initiatives, although external validation is required before clinical implementation.
Primary biliary cholangitis (PBC) is a rare chronic cholestatic disease that despite current therapy has significant ongoing unmet needs, including risks of cirrhosis and life-impairing symptoms. The current treatment approach is a step-up model, wherein first-line therapy, ursodeoxycholic acid (UDCA), is given for a minimum of 12 months before the addition of second-line therapy is considered for non-responding patients. This ‘waiting to fail’ approach, focused on the needs of low-risk patients, allows, we postulate, a key process of biliary epithelial cell (BEC) senescence to become established, driving accelerated bile duct loss and aggressive disease. Preclinical mouse modelling has shown that early use of the farnesoid X receptor agonist obeticholic acid (OCA), currently only used as second-line therapy following UDCA failure, reverses BEC senescence, changing the clinical course of disease. Here, we describe the design of the Optimising Primary thErapy in pRimAry biliary cholangitis (OPERA) trial. The aim of OPERA is to explore a new paradigm for disease-modifying treatment of PBC: risk-informed early treatment stratification, with patients at increased risk offered UDCA and OCA combination with the goal of complete biochemical remission.
OPERA is a multicentre, randomised, double-blind, placebo-controlled trial of OCA in combination with UDCA, as first-line treatment for high-risk PBC. This is a multicentre trial in England, which will be undertaken in specialist clinics in secondary/tertiary referral centres (or as per local set up). These centres will be specialists in the area of PBC management and will manage patients from across their local region. OPERA will recruit and randomise 106 adults, within 6 months of PBC diagnosis, who are at an enhanced risk of non-response to standard first-line therapy, between either: (1) UDCA and OCA or (2) UDCA and matched placebo in a 1:1 ratio. The primary efficacy outcome measure is the percentage of participants showing normalisation of serum alkaline phosphatase and total bilirubin values at 26 weeks (disease remission).
Favourable ethical opinion was received from London – Riverside Research Ethics Committee (reference: 22/LO/0878). Potential participants will be fully informed of their rights and the benefits and harms of the trial by the research team before giving informed consent to participate in the trial. Results will be disseminated in peer-reviewed publications, at national and international conferences, in peer-reviewed journals and to participants and the public (using lay language).
by Job Kasule, Julius L. Tonzel, Natalie Burns, Tyler Hamby, Roger Ying, Grace Mirembe, Immaculate Nakabuye, Hannah Kibuuka, Margaret Yacovone, Betty Mwesigwa, Trevor A. Crowell, for the Multinational Observational Cohort of HIV and other Infections (MOCHI) Study Group
BackgroundPeople with behavioral vulnerability to HIV face barriers to healthcare engagement that may impede uptake of non-pharmaceutical and other interventions to prevent COVID-19. Understanding COVID-19 knowledge, attitudes, and practices in this population can inform disease prevention efforts during future pandemics.
Materials and methodsFrom October 2022 to September 2024, we enrolled participants aged 14–55 years without HIV who endorsed recent sexually transmitted infection, injection drug use, transactional sex, condomless sex, and/or anal sex with male partners. At enrollment, we collected socio-behavioral data, including assessments of COVID-19 knowledge, attitudes, and practices. Robust Poisson regression with purposeful variable selection was used to estimate prevalence ratios with 95% confidence intervals for factors associated with COVID-19 preventive practices.
ResultsAmong 418 participants, 228 (56.9%) were female, the median age was 21 years (interquartile range 19−24), and 362 (84.9%) reported sex work. Knowledge about SARS-CoV-2 transmission routes was high (95.4%) but lower for the consequences of genetic variants (48.5%−69.7%) and possibility for asymptomatic infection or transmission (66.7%−80.8%). Handwashing was practiced by 90.8% of participants in the preceding month, whereas mask-wearing (76.5%), avoiding symptomatic people (73.7%), and any history of COVID-19 vaccination (46.9%) were less prevalent. Males were more likely to report avoiding symptomatic people (adjusted prevalence ratio 1.16 [95% confidence interval 1.03–1.31]) and COVID-19 vaccination (1.30 [1.05–1.60]). Enrollment during the BQ.1/BQ.1.1 Omicron wave was associated with less mask-wearing (0.81 [0.67–0.99]) but more vaccination (1.59 [1.29–1.95]).
DiscussionWe observed variable COVID-19 knowledge and attitudes among Ugandan adolescents and adults with little impact on COVID-19 preventive practices. Efforts to address suboptimal uptake of disease preventive practices during this and future disease outbreaks will require more than just improving knowledge.
by Viral D. Oza, Colin S. Williams, Jessica S. Blackburn
The Genetically Encoded Death Indicator (GEDI) is a ratiometric, dual-fluorescence biosensor that enables real-time detection of cell death through calcium influx. Originally developed for use in neurodegeneration models, GEDI can be applied to cancer cells to quantify therapy-induced death at single-cell resolution. This protocol details how to generate GEDI-expressing cancer cell lines, empirically determine stress-induced GEDI thresholds using radiation or chemotherapeutic agents, and perform time-resolved imaging and image analysis to track cell fate. This workflow is optimized for high-throughput drug and radiation screening in heterogeneous populations and is especially useful for identifying chemo- and radio-resistant subclones. Key limitations include the need for empirical GEDI threshold calibration for each treatment condition and careful standardization of imaging parameters. The protocol outputs include GEDI ratio values, single-cell time-of-death annotations, and whole-cell morphological data in parallel, which can be linked to downstream applications such as FACS-based isolation of live or dying subpopulations, transcriptomic profiling of resistant clones, or in vivo validation using xenografts or organotypic slice culture.Surgical site infections (SSI) in vascular surgery have a huge impact on patients’ morbidity and mortality and healthcare systems worldwide. Dialkylcarbamoylchoride (DACC) is a synthetically produced material that can irreversibly bind and inactivate bacteria that exhibit cell-surface hydrophobicity (CSH). The DACC in the Reduction of Surgical Site Infection (DRESSINg) trial is a multicentre randomised controlled trial which aims to assess the effectiveness of DACC-coated post-operative dressings in the prevention of SSI in vascular surgery. Seven hundred and eighteen participants undergoing clean or clean-contaminated lower limb vascular surgery will be randomised in a 1:1 ratio to either DACC-coated dressings or standard dressings for their postoperative wounds. The primary outcome is the incidence of SSI defined by the Centers for Disease Control and Prevention (CDC) criteria or total ASEPSIS score of 21 or more within 30 days of surgery. The secondary outcomes include satisfactory wound healing with a total ASEPSIS score of 10 or less, quality of life pre and post surgery, Bluebelle wound healing scores, resource use and financial (£), and environmental (KgCO2e) cost analyses. This multicentre randomised controlled trial will provide level 1 evidence on the effectiveness of preventing SSI in lower limb vascular surgery.
To compare HIV testing coverage, prevalence and care cascade engagement between fisherfolk and the general population, and to assess the relevance of individual and community-level definitions of fisherfolk in understanding variation in HIV status and testing.
Primary data collection and cross-sectional analysis in 1 year of the SchistoTrack community-based cohort.
52 shoreline villages in Pakwach, Buliisa and Mayuge districts in rural Uganda.
A total of 3197 individuals aged 5–92 years were tested for HIV in 2024. A subset of 124 HIV-positive participants had viral load measured in 2025. Statistical analyses focused on 1931 adults aged 15 years and older.
The primary outcomes were lifetime HIV testing, testing in the past 12 months and current HIV status. Secondary measures included self-reported care cascade outcomes and viral load suppression.
Overall, 6.94% (134/1931) of adult participants aged 15 years and older were with HIV (people with HIV (PWH)), of whom 22.39% (30/134) were newly diagnosed. 6% (25/415) of adults reporting fishing activities were HIV-positive. Of those, 80% (20/25) were status-aware, 76% (19/25) were on antiretroviral therapy, and 100% (8/8) of those who knew their viral load reported viral suppression. No significant differences in care cascade engagement were found between PWH reporting fishing activities and the general population. Measured viral suppression was 70.59% (72/102) among PWH with no significant differences by fishing activities. Fishing activities were significantly associated with higher odds of ever testing for HIV (OR 1.76 (95% CI 1.22 to 2.54)), but not with testing in the past 12 months or HIV status. No consistent district-level differences were observed.
Individuals reporting fishing activities had higher lifetime testing and comparable HIV prevalence and care cascade engagement to the general population. Gaps remain in recent testing, status awareness and viral suppression for fisherfolk.
Within the UK there are 33 deaths every day from prostate cancer, second only to lung cancer as the most common cause of cancer death in males in the UK. Of the 55 000 new cases each year, up to 50% of these patients will receive radiotherapy either alone or after prostatectomy. Although there have been significant improvements in the accuracy of radiotherapy delivery leading to better tumour targeting and a reduction in dose to normal tissues, significant permanent genito-urinary or gastrointestinal-related side effects are all too common. With nearly 80% of patients with prostate cancer surviving for 10 years or more, minimising life-limiting radiation damage to normal tissues is vitally important. However, at present, it is not possible to identify which patients will suffer a poorer outcome after radiotherapy. The aim of this study, improving radiotherapy in PROState cancer using EleCtronic population-based healthCAre data (PROSECCA), is to do this by using the existing information in a patient’s digital healthcare record. By linking primary, secondary and tertiary clinical data, including digital image information, with radiotherapy treatment plans and outcome data, the PROSECCA study will identify de novo predictive biomarkers of radiation response and provide clinicians with a tool to individualise a radiotherapy dose and plan to maximise cure and minimise toxicity.
The PROSECCA study is a large multidisciplinary project, the purpose of which is to analyse healthcare records from up to 15 000 patients with prostate cancer who underwent radiotherapy in the treatment of their cancer in Scotland between 2010 and 2022. Through the linkage of data obtained specifically for radiotherapy and data held within each patient’s unique electronic health record (EHR), the factors that indicate why some patients have a poor response to treatment, or an increased risk of side effects from radiation, will be identified. This will be made possible by the use of artificial intelligence and machine learning (AL/ML), which will help to identify at-risk patients earlier and allow adaptation of their treatment accordingly.
The study is being conducted in accordance with the ethical principles set out in the Declaration of Helsinki and Good Clinical Practice that respects and protects the rights, and maintains confidentiality, of all trial participants. The study protocol (V.1.0) was reviewed by the South Central Oxford A Research Ethics Committee (REC) on 13 December 2021 and received a favourable opinion subject to each National Health Service (NHS) organisation confirming permission for patients treated within their area. Approval for the use of unconsented healthcare record data for patients included in the study and treated at one of the five Scottish Cancer Centres required an application to the NHS Scotland Public Benefit and Privacy Panel for Health and Social Care (HSC-PBPP). Full approval from the HSC-PBPP panel was received on 1 July 2024, which covered the use of pseudoanonymised EHR data for all patients participating in the study. The study is publicly listed on the NHS Health Research Authority site, with IRAS ID 306245 and REC reference 21/SC/0402. Dissemination of the study findings will take place through field-leading cancer, radiation oncology and medical physics journals. All manuscripts will be approved by the main study team and authorship determined by mutual agreement.
Glaucoma is the leading cause of irreversible blindness worldwide and the number of people with glaucoma is expected to increase to more than 112 million by the year 2040, making it a disease of public health interest. However, there is no consensus on public health indicators to monitor glaucoma care coverage. This scoping review aims to summarise published indicators for monitoring effective glaucoma care coverage globally, focusing on care needs, use of care services and outcomes achieved.
We will include studies that report the development and use of public health indicators for effective glaucoma care coverage in patients aged 18 years and older. Studies published from 1 January 2000, in all languages, will be included, provided they can be accurately and easily translated into English using Google Translate. Searches will be conducted by an information specialist on MEDLINE, Embase, Global Health and CENTRAL in the Cochrane Library. Two reviewers working independently will screen the search results, select studies for inclusion and extract data; any disagreements will be discussed with or resolved by a third reviewer. Data will be presented in tabular form, followed by a narrative synthesis based on the review objectives.
Ethical approval is not required as the review will use published data. Results will be published in a peer-reviewed journal, and summarised results will be available and contribute to the development of standardised glaucoma care indicators.
OSF registration on 19 May 2025: https://osf.io/zsyw9/
The COVID-19 pandemic accelerated telehealth adoption, offering remote consultations via phone and video. Allied health services are one part of the healthcare system where telehealth, in specific teleconsultations, has been applied and has shown promising results in improving healthcare access by breaking down financial, logistical and geographic barriers. However, more insight is needed into the consumer’s perspective. A consumer is anyone who has used, currently uses or will use telehealth for allied health services. Therefore, this study explores consumer experiences and preferences, identifying barriers and facilitators to telehealth for allied health services.
This qualitative study used focus group discussions to evaluate consumers’ experiences with telehealth for allied health services. Allied health was defined as healthcare professionals distinct from medical, dental and nursing fields. Eight focus groups with 57 participants were conducted. The participants were recruited from the general public as well as seldom represented communities such as a support service focused on improving and maintaining members’ mental health, the deaf and hard-of-hearing community, young disabled people and the Pacific Islander community. An inductive thematic analysis was used to analyse the data.
Five main themes were identified. First, the consumer with their individual characteristics and context played a major role in the suitability of telehealth. Second, the allied health practitioner and their skills influenced the quality and therefore the success of remote consultations. Further, the relationship between consumer and practitioner contributed to the success of telehealth. The appointment itself was equally often discussed. While telehealth improved access to care, remote appointments were seen as more suitable for questions and verbal exchanges. Lastly, the technology was an important factor with the availability of necessary technology and the accessibility of it playing a central role.
The findings reinforce existing research while highlighting new insights from often under-represented groups, emphasising the importance of telehealth choice, accessible technology and quality standards.
To establish the suitability of self-determination theory as a theoretical framework to inform research and design of digital applications for nurses' well-being.
This discursive paper describes the background and core premises of self-determination theory and explains its relevance as a theoretical framework to support research and the design of digital applications to promote nurses' well-being.
Increasing numbers of digital applications are being used by nurses, but few are supported by clearly explicated theoretical frameworks. Self-determination theory focuses on how people's innate psychological needs interact and are influenced by the social environments where they live and work. Given the influence the social environment can have on well-being, self-determination theory is well suited as a theoretical framework to inform research and design of digital applications promoting nurses' well-being.
Stress and burnout impact nurses worldwide, to the detriment of staff well-being, their retention in health services, and provision of patient care. The rapid development and ubiquitous use of digital applications by nurses make researching their effectiveness vitally important if nurses' well being is to be supported. Self-determination theory provides a theoretical framework useful for these applications.
Through the lens of self-determination theory, researchers, digital application designers, and organisations can garner further insights to support digital application development and implementation for the well-being of nurses.
This paper has international relevance and can assist researchers, application designers, and organisations interested in promoting nurses' well-being through understanding the applicability and usefulness of self-determination theory as a theoretical framework for the design of digital applications for nurses' well-being.
No Patient or Public Contribution.
Nasogastric tubes (NGTs) are standard practice in the management of adhesive small bowel obstruction (ASBO). Their insertion can be associated with significant patient discomfort and complications. Current research suggests that patients with ASBO managed with NGTs may experience poorer outcomes and higher rates of operative intervention compared with those managed without. However, to date, there are no prospective clinical trials evaluating this.
This study will be designed as a single centre, prospective, non-inferiority randomised controlled trial to determine if the avoidance of an NGT is non-inferior to its use in ASBO. Patients meeting inclusion criteria will be randomised to either receive an NGT or no NGT for ASBO management. The primary outcome will be the rate of operative intervention as determined by review of medical records at day 30 post discharge. Secondary outcomes will include rate of bowel resection or bowel ischaemia, length of hospital and intensive care unit (ICU) stay, time to operative intervention, rate of ICU admission, incidence of postoperative complications (Clavien-Dindo classification), quality of life scores (European Quality of Life 5 Dimension 5 Level: EQ-5D-5L) at admission, day 30 and day 90, 90-day mortality, incidence of pulmonary complications (Melbourne Group Scale), rate of NGT specific complications and rate of Gastrografin use. The study will be powered at 80% to detect a clinically relevant difference of 10% between groups receiving an NGT compared with no NGT, requiring a total of 490 study participants. Statistical analysis will follow intention to treat principles. Differences between treatment arms will be summarised using mean differences, 95% CIs and p values.
This study has been approved by the Hunter New England Human Research Ethics Committee (2023/ETH00296). Results will be disseminated through peer-reviewed publication and conference presentations.
This study has been registered prospectively in the Australia and New Zealand Clinical Trials Registry (ACTRN12623000341628).
Gram negative bloodstream infections (GN BSI) are a leading cause of mortality worldwide, and antibiotic treatment approaches remain understudied. BALANCE+ is a perpetual Bayesian adaptive platform trial to test multiple treatment questions for hospitalised patients with GN BSI. The vanguard phase objective was to test the feasibility of the main trial.
Adaptive platform trial with five initial domains of investigation, each with open label 1:1 randomisation.
Ten hospitals across four Canadian provinces.
Individuals admitted to hospital with blood cultures yielding Gram negative bacteria.
The five initial domains of investigation included: antibiotic de-escalation versus no de-escalation; oral transition to beta-lactam versus non-beta-lactam treatment; routine versus no routine follow-up blood cultures (FUBCs); central vascular catheter replacement versus retention; and, ceftriaxone versus carbapenem treatment for low risk AmpC organisms.
Domain-specific recruitment rates and protocol adherence.
During the vanguard phase, 719 patients were screened, of whom 563 (78.3%) were eligible, with 179 (31.8%) enrolled into the platform. The platform recruitment rate was 1.37 patients/site-week. Recruitment varied by domain: routine versus no FUBC domain 1.23 patients/site-week; oral beta-lactam versus non-beta-lactam domain 0.48; de-escalation versus no de-escalation domain 0.28; low risk AmpC domain 0.02; catheter replacement versus retention domain 0.01. Domain specific protocol adherence rates were 145/158 (91.8%) for routine versus no routine FUBC, 53/60 (88.3%) for oral beta-lactam versus non-beta-lactam, 26/33 (78.8%) for de-escalation versus no de-escalation, 3/3 (100%) for low risk AmpC, and 0/1 (0%) for line replacement versus retention. There was complete ascertainment of all study outcomes in hospital 170/170 (100%) and near complete ascertainment at 90 days 162/170 (95.3%).
The vanguard phase demonstrated overall trial feasibility by recruitment rate and protocol adherence, with differences across interventions, leading to a transition to the main BALANCE+ platform trial with minimal protocol modifications.
This study aimed to evaluate the feasibility of delivering a vocational rehabilitation intervention (Return to Work After Trauma—ROWTATE), remotely to individuals recovering from traumatic injuries. The primary objectives were to assess therapists’ training and competence, adapt the intervention and training for remote delivery and assess the feasibility and fidelity of remote delivery to inform a definitive randomised controlled trial.
A mixed-methods feasibility study incorporating (1) telerehabilitation qualitative literature review, (2) qualitative interviews preintervention and postintervention with therapists and patients, (3) a team objective structured clinical examination to assess competency, (4) usefulness of training, attitudes towards (15-item Evidence-Based Practice Attitude Scale) and confidence in (4-item Evidence Based Practice Confidence Scale) evidence-based practice, intervention delivery confidence (8-bespoke questions) and intervention behaviour determinants (51-items Theoretical Domains Framework) and (5) single-arm intervention delivery feasibility study.
The study was conducted in two UK Major Trauma Centres. The intervention and training were adapted for remote delivery due to the COVID-19 pandemic.
Therapists: Seven occupational therapists (OTs) and clinical psychologists (CPs) were trained, and six participated in competency assessment. Seven OTs and CPs participated in preintervention interviews and surveys; six completed post-intervention interviews and four completed post-training surveys. Patients: 10 patients were enrolled in the single-arm feasibility study and 4 of these participated in postintervention qualitative interviews. Inclusion criteria included therapists involved in vocational rehabilitation delivery and patients admitted to major trauma centres. Exclusion criteria included participation in other vocational rehabilitation trials or those who had returned to work or education for at least 80% of preinjury hours. Intervention: The ROWTATE vocational rehabilitation intervention was delivered remotely by trained OTs and CPs. Training included competency assessments, mentoring and adaptation for telerehabilitation. The intervention was delivered over multiple sessions, with content tailored to individual patient needs.
Therapists found the training useful, reported positive attitudes (Evidence-Based Practice Attitude Scale mean=2.9 (SD 0.9)) and high levels of confidence in delivering evidence-based practice (range 75%–100%) and the ROWTATE intervention (range 80%–100%). Intervention barriers identified pretraining became facilitators post-training. Half the therapists needed additional support post-training through mentoring or additional training. The intervention and training were successfully adapted for remote delivery. High levels of fidelity (intervention components delivered: OTs=84.5%, CPs=92.9%) and session attendance rates were found (median: OT=97%, CP=100%). Virtually all sessions were delivered remotely (OT=98%, CP=100%). The intervention was acceptable to patients and therapists; both considered face-to-face delivery where necessary was important.
The ROWTATE intervention was delivered remotely with high fidelity and attendance and was acceptable to patients and therapists. Definitive trial key changes include modifying therapist training, competency assessment, face-to-face intervention delivery where necessary and addressing lower fidelity intervention components.
People experiencing severe and multiple disadvantage (SMD: homelessness, substance use and criminal offending) have multiple intersecting unmet health and social care needs and high mortality rates, often due to street-drug overdose. Pilot randomised controlled trials (RCTs) suggest an integrated, holistic, collaborative outreach intervention (Pharmacy Homeless Outreach Engagement Non-medical Independent Prescribing Rx (PHOENIx)) involving generalist-trained pharmacists, nurses or General Practitioners accompanied by staff from third sector homeless organisations may improve outcomes, including reducing overdose.
Multicentre, parallel group, prospective RCT with parallel economic and process evaluation. Set in six areas of Scotland, UK, 378 adults with SMD will be recruited and randomised (stratified by setting and previous non-fatal overdoses) to PHOENIx intervention in addition to usual care (UC) or UC. Aiming to meet participants weekly for 9–15 months, PHOENIx teams assess and address health and social care needs while referring onwards as necessary, co-ordinating care with wider health and third sector teams. During a person-centred consultation, in the participants’ choice of venue, and taking account of the participant’s priorities, the NHS clinician may prescribe, de-prescribe and treat, for example, wound care, and refer to other health services as necessary. The third sector worker may help with welfare benefit applications, social prescribing or advocacy, for example, securing stable housing. Pairings of clinicians and third sector workers support the same participants. The primary outcome is time to first fatal/non-fatal street-drug overdose at nine months. Secondary endpoints include health-related quality of life, healthcare use and criminal justice encounters. A health economic evaluation will assess cost per quality adjusted life year of PHOENIx relative to standard care. A parallel qualitative process evaluation will explore the perceptions and experiences of PHOENIx, by participants, stakeholders and PHOENIx staff.
The primary and other time-to-event secondary outcomes will be analysed by Cox proportional hazards regression.
IRAS number 345246, approved 23/10/2024 by North of Scotland Research Ethics Service. Results will be shared with participants, third sector homelessness organisations, health and social care partnerships, then peer-reviewed journals and conferences worldwide, from the first quarter of 2027.
ISRCTN12234059 registered on 20/2/2025 (ISRCTN).
Growing evidence points towards the integral role of both central and peripheral inflammation across all neurodegenerative diseases, including dementia with Lewy bodies (DLB) and Alzheimer’s disease (AD). The immune alterations observed in these diseases may occur long before the onset of clinical and cognitive symptoms; however, the exact timing and role of inflammation in the pathogenesis of neurodegenerative disease remains unclear. Findings to date are conflicting, with most work focused on AD rather than other dementias and most studies from single sites and cross-sectional. Through longitudinally examining detailed phenotypes of the peripheral immune system using mass cytometry, the Immune Profiling in Early Cognitive Disorders study aims to uncover specific immune signatures in early AD and DLB, how these signatures change over time and how they relate to disease progression and cognitive changes.
Blood, cerebrospinal fluid, saliva and urine samples will be collected from a cohort of participants with either prodromal (mild cognitive impairment) or early dementia due to Lewy bodies or AD (MCI-LB and DLB; and MCI-AD and AD), alongside healthy controls. Through immunophenotyping with mass cytometry, detailed immune fingerprints will be identified for these groups. We will assess which key combinations of immune cell clusters are predictive of disease phenotype, cognitive decline and progression to dementia. Samples will also be evaluated with novel techniques to measure markers of degenerative pathology and inflammation.
This study was approved by the Preston North West Research Ethics committee (21/NW/0314) and is registered with the ISRCTN registry (ISRCTN62392656). The study is ongoing (since June 2022). Baseline visits are being undertaken, and follow-up visits have started for some participants. Full data analyses will be completed and submitted for publication upon conclusion of the study.
FreshRSS 