Mental health issues such as depression and anxiety are highly and disproportionally prevalent among university students. Beyond the academic rigour, stressors imposed by a new environment result in them being vulnerable to the onset and manifestation of mental health symptomatology. Leveraging smartphones and wearables for digital phenotyping capabilities is an innovative approach for monitoring and intervening in the mental health conditions of university students. This provides a unique opportunity to collect and identify digital and behavioural biomarkers, subsequently enabling the development of predictive models to identify university students at risk.

This study—Brightline—will employ an observational study design over a 6-month period, recruiting 500 students from a major public university in Singapore. Passive data collection will occur continuously throughout the monitoring period through a wearable device (Fitbit Charge 6) and smartphone sensors via the Brightline app, which uses a digital phenotyping data collection platform. Active data collection will consist of self-report questionnaires to be completed at the beginning of the study and follow-up assessments at 1, 3 and 6 months after. The passive and active data collected will be analysed to identify the digital biomarkers associated with depression, anxiety, stress, loneliness and affect among university students. Predictive models of these mental health issues will also be developed.

This study was approved by the Nanyang Technological University Institutional Review Board (IRB-2023-894). Findings from this study will be published in peer-reviewed journals and presented at academic conferences.

NCT06770075.

Many people with psychosis find the world very frightening. It can be difficult for them to do everyday things—for example, walking down a busy street, travelling on a bus or going to the shops. Sometimes, the fears are so great that individuals rarely leave their homes. gameChange virtual reality therapy is designed to reduce this agoraphobic avoidance. In gameChange, users practise going into computerised immersive versions of ordinary situations. A virtual therapist guides users through the programme. A mental health worker also supports people. People normally do six sessions of gameChange, but now they can do more as headsets can be left with many people. We originally tested gameChange with 346 patients with psychosis. People saw a significant reduction in their fears. People with the most severe problems made the biggest improvements. This led to gameChange receiving National Institute for Health and Care Excellence (NICE) Early Value Assessment (EVA) approval for its use with patients with psychosis who have severe agoraphobic avoidance. NICE EVA approval is conditional on further evidence generation. We aim to carry out a real-world trial of gameChange used in the NHS. The overall aim is to gather evidence on the four essential areas (clinical benefits on agoraphobia, level of engagement and adherence, healthcare resource use, adverse effects) and the two further supporting areas (health-related quality of life, generalisability) identified in the NICE evidence generation plan for gameChange.

200 patients with psychosis and severe agoraphobic avoidance will be randomised (1:1) to receive gameChange in addition to treatment as usual (TAU) or to a waitlist control group receiving TAU. Assessments will be conducted blind to group allocation at baseline, 8 weeks (end of treatment) and 26 weeks (follow-up). The trial will be embedded in services in at least seven National Health Service (NHS) trusts across England. The primary outcome is agoraphobic avoidance at 26 weeks assessed with the Oxford Agoraphobic Avoidance Scale. The secondary clinical outcomes are agoraphobic distress, paranoia and social contacts. There will be tests of moderation of the main clinical outcome. Treatment acceptability, adverse effects and cost-effectiveness will also be assessed. The target estimand is the treatment policy estimand and all primary and secondary analyses will be carried out incorporating data from all participants including those who do not complete treatment.

The trial has received ethical approval from the NHS Health Research Authority and Health and Care Research Wales (25/WA/0081). A key output will be the evidence needed for a NICE guidance update on gameChange and a clear recommendation concerning future routine use in the NHS.

ISRCTN79060696.

Poor chest health is the leading cause of early mortality in children with cerebral palsy (CP). It is also the most common reason to seek healthcare, accruing significant costs and reducing quality-of-life for children and families. Clinical trials examining chest health interventions in CP are characterised by inconsistent outcome measures, limiting the capacity for evidence synthesis to inform clinical application. The study aims to develop a core outcome set (COS) and related measurement instruments to assess, monitor and evaluate chest health in children with CP, both in research and routine clinical practice. The COS will reflect the views of children, young people, parent/carers, clinicians and researchers, emphasising under-represented groups in research and those at risk of poorer chest health.

A 3-phase methodology will be conducted in line with the Core Outcome Measures in Effectiveness Trials (COMET) Initiative. (1) Candidate outcomes will be identified through a qualitative evidence synthesis and interviews with key stakeholders. Findings will be mapped to COMET-taxonomy, generating a list of candidate outcomes. (2) An international e-Delphi survey will invite stakeholders to rate the importance of each outcome, followed by a consensus meeting to ratify the COS. (3) A structured review, guided by health measurement taxonomy, will evaluate relevant instruments, with a final meeting to agree on recommended measures for each COS domain.

Ethical approval was provided by the University of Plymouth Research Ethics Committee for the qualitative interview study (ID5116), e-Delphi study and consensus meeting (ID5636). Study findings will be published open access in a peer-reviewed journal and presented at relevant national and international conferences.

COMET registration: 2590 (https://www.comet-initiative.org/Studies/Details/2590)

CRD42024562735.

This scoping review aimed to map studies on behaviour change interventions that address antibiotic treatment-seeking behaviour for respiratory tract infections in primary and community care settings.

This review is based on the Joanna Briggs Institute guidelines for scoping reviews, guided by the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews.

A literature search in January 2024 and May 2024 was performed across Medline, Embase, CINAHL, PsycINFO, Web of Science Core Collection, Scopus, EThOS and Google Scholar was performed.

Eligible studies described behaviour change interventions in primary and community care settings, published from 2000 onward across all countries.

Descriptive data relating to study details and intervention functions were gathered and organised according to the Capability, Opportunity, Motivation and Behaviour change framework in a predeveloped data extraction sheet. Dual data extraction occurred, and inter-rater reliability results are reported (K=0.83).

The scoping review identified 38 eligible studies, which consisted of randomised controlled trials (7/38), cluster randomised controlled trials (6/38), randomised experiments (5/38), cross-sectional studies (5/38), qualitative investigations (5/38) and quasi-experimental designs (4/38). Most interventions focused on educational resources (15/38), digital tools (7/38) and community campaigns (6/38), with fewer targeting decision-making processes (4/38) or psychological drivers of antibiotic-seeking behaviour (3/38). Only one study was conducted in low-income and middle-income countries, and only one separately assessed behaviour change as a measured outcome.

This scoping review highlights a wide range of research methodologies within the topic area. There was some limited evidence of intervention efficacy for antibiotic prescription rates, particularly interventions focused on enhancing knowledge and access to resources. However, more emphasis is needed on standardising outcome measures and evaluating long-term outcomes.

As the opioid crisis continues, people who use drugs (PWUD) experience a disproportionate burden of both HIV and overdose, driven by increased injection-related HIV outbreaks and an opaque and rapidly evolving drug market, respectively. Pre-exposure prophylaxis (PrEP) for HIV and point-of-care drug checking services are underused yet potentially impactful interventions to address the harms of the opioid crisis. Implementing such interventions using known strategies to enhance client engagement and reduce access barriers, such as street outreach, mobile services and peer navigation, can optimise intervention and maximise their impact.

The Substance Checking Outreach and PrEP Engagement (SCOPE) Study is a non-randomised clinical trial evaluating the impact of the Check It intervention, a mobile community PrEP and drug checking intervention in Baltimore, Maryland, USA. SCOPE will recruit a cohort of 500 PWUD at risk for HIV through street-based recruitment methods. Cohort members will be followed semi-annually for 18 months. The primary study outcomes are engagement with the PrEP continuum of care and the number of non-fatal overdoses. We will use both random effects models and marginal structural models to estimate the effects of Check It on participant engagement on the PrEP continuum and the number of non-fatal overdoses over time.

Study procedures have been approved by the Johns Hopkins Bloomberg School of Public Health Institutional Review Board. Risks to participants are low, with the most serious risk being potential data confidentiality breaches. This risk was minimised through the use of secure data storage platforms with limited user access. Study findings will be disseminated through peer-reviewed manuscripts, academic presentations, and reports and fact sheets designed for lay audiences.

This study was registered with clinicaltrials.gov (study ID: NCT05977881; Protocol ID: 00017498).

Persons living with HIV (PLWH) have an augmented risk of cardiovascular disease, including atherosclerosis and myocardial dysfunction, despite effective viral suppression with antiretroviral therapy. Despite the majority of PLWH residing in sub-Saharan Africa, there are limited reports from the region on structural cardiovascular changes due to this residual risk.

The Early Structural Cardiovascular Disease, HIV, and Tuberculosis in East Africa (ASANTE) cross-sectional study will be conducted in a public hospital in Nairobi, Kenya. It will enrol 400 participants (50% women, 50% PLWH) to undergo cardiovascular phenotyping using multimodal imaging (coronary CT angiography (CCTA) and echocardiography) and banking of biological samples (whole blood, peripheral blood mononuclear cells, plasma and urine). We will define the prevalence of subclinical coronary atherosclerosis by CCTA and subclinical myocardial dysfunction by transthoracic echocardiography and evaluate both traditional and non-traditional risk factors, including endemic infections such as latent tuberculosis. This study will contribute important data on phenotypes of and risk factors for HIV-associated cardiovascular disease in this understudied region.

Ethical approval for the ASANTE study was granted by the University of Nairobi-Kenyatta National Hospital Ethical Review Committee, Nairobi, Kenya, and the University of Washington Institutional Review Board, USA. Results will be submitted for publication in peer-reviewed journals.

High-quality clinical practice guidelines and hospital standards on falls prevention and management now exist, yet their implementation into clinical practice is variable. Insights from consumers could help to guide the development of a process to improve the implementation of falls prevention and management, particularly in rehabilitation hospitals where fall rates are high.

A qualitative descriptive study will incorporate semistructured interviews and focus groups to explore the perspectives of hospital consumers on how hospital falls prevention evidence can best be implemented into rehabilitation practice. Thematic analysis of the data will be conducted in NVivo using a six-phase thematic coding process guided by Braun and Clarke. Evaluation and synthesis of the data will also follow the Consolidated Criteria for Reporting Qualitative Research checklist. Consideration of the results from the interviews and focus groups will provide insights into the views of people with lived experience of hospitalisation and falls. Thematic analysis will be supported by direct quotes for each key theme and will highlight how the themes relate to the study aims and the rehabilitation context.

The study was approved by La Trobe University Human Research Ethics Committee (HEC24526). The study will be published in a peer-reviewed journal, and findings will be presented at conferences, workshops and online events.

Persecutory delusions are very common in severe mental health disorders such as schizophrenia. Existing treatments often do not work well enough. We developed a face-to-face theory-driven psychological intervention, called Feeling Safe, that produces very large reductions in persistent persecutory delusions. The challenge now is to make Feeling Safe widely available. So, we developed a 6-month supported online version, called Feeling Safer. The aim is an intervention that patients can easily access and use, reduces persecutory delusions and can be supported by a range of mental health professionals in less contact time than face-to-face therapy. Initial proof of concept testing of Feeling Safer was very encouraging. In a randomised controlled trial, we now plan to test whether Feeling Safer is efficacious for patients and can be successfully delivered by any of three different mental health staff groups (peer-support workers, graduate psychologists and cognitive behavioural therapy (CBT) therapists). We will also test whether Feeling Safer works equally across gender, age, ethnicity and cognitive functioning (moderation) and whether Feeling Safer works via the targeted psychological processes (mediation).

The study design is a multicentre, single-blind (outcome assessor), parallel, four-arm randomised controlled trial; 484 patients with persistent persecutory delusions will be randomised to one of the four conditions (1:1:1:1): Feeling Safer (added to treatment as usual (TAU)) supported by peer-support workers, or Feeling Safer (added to TAU) supported by graduate mental health workers including assistant psychologists, or Feeling Safer (added to TAU) supported by CBT therapists or TAU. Feeling Safer will be provided for 6 months with a staff member. Assessments will be conducted at 0, 3, 6 and 9 months by research assistants blind to group allocation. The primary outcome is severity of persecutory delusions at 6 months rated with the Psychotic Symptoms Rating Scale—Delusions. The secondary outcomes are other psychiatric symptoms (depression, anxiety, insomnia, agoraphobia and paranoia), psychological well-being, recovery, activity and health-related quality of life. Analysis will be conducted under a treatment policy strategy following the intention-to-treat principle, incorporating data from all participants including those who do not complete treatment. Moderation and mediation will be tested. A within-trial cost-effectiveness analysis will be conducted of Feeling Safer compared with TAU.

The trial has received ethical approval from the NHS Health Research Authority (23/LO/0951). Informed consent will be obtained from all participants. A key output will be an open-access publication in a peer-reviewed journal reporting on the clinical effectiveness of a high-quality supported online programme for the treatment of persecutory delusions that has the potential to be used at scale in mental health services.

ISRCTN93974770.

This study aims to determine key workforce variables (demographic, health and occupational) that predicted National Health Service (NHS) staff’s absence due to illness and expressed intention to leave their current profession.

Staff from 18 NHS Trusts were surveyed between April 2020 and January 2021, and again approximately 12 months later.

Logistic and linear regression were used to explore relationships between baseline exposures and four 12-month outcomes: absence due to COVID-19, absence due to non-COVID-19 illness, actively seeking employment outside current profession and regularly thinking about leaving current profession.

22 555 participants (out of a possible 152 286 employees; 15%) completed the baseline questionnaire. 10 831 participants completed the short follow-up questionnaire at 12 months and 5868 also completed the long questionnaire; these participants were included in the analyses of sickness absence and intention to leave, respectively. 20% of participants took 5+ days of work absence for non-COVID-19 sickness in the 12 months between baseline and 12-month questionnaire; 14% took 5+ days of COVID-19-related sickness absence. At 12 months, 20% agreed or strongly agreed they were actively seeking employment outside their current profession; 24% thought about leaving their profession at least several times per week. Sickness absence (COVID-19 and non-COVID-19 related) and intention to leave the profession (actively seeking another role and thinking about leaving) were all more common among NHS staff who were younger, in a COVID-19 risk group, had a probable mental health disorder, and who did not feel supported by colleagues and managers.

Several factors affected both workforce retention and sickness absence. Of particular interest are the impact of colleague and manager support because they are modifiable. The NHS workforce is likely to benefit from training managers to speak with and support staff, especially those experiencing mental health difficulties. Further, staff should be given sufficient opportunities to form and foster social connections. Selection bias may have affected the presented results.

Prompt recognition and treatment of patients with sepsis improve survival. Patients transported to hospital with sepsis often do not receive treatment until they are assessed in emergency departments. Initiation of treatments by paramedics at the point of first contact may improve outcomes for these patients.

The study design involves two randomised controlled trials (RCTs) conducted using a 2x2 factorial design comparing use of (1) early intramuscular ceftriaxone versus placebo and (2) an early liberal intravenous fluid strategy (up to 2 L normal saline) versus usual care resuscitation guided by paramedic medical directives. Patients who are ≥18 years of age will be eligible for inclusion if they have sepsis, defined as (1) paramedic suspicion of infection, (2) fever (temperature ≥38.0°C measured by paramedic or history of fever during the previous 24 hours), and (3) hypotension: SBP 250 mL) within 24 hours of hospital arrival; total amount of crystalloid infused during transport and first 24 hours of hospitalisation; and proportion of enrolled patients not suspected to have sepsis or infection by emergency department physicians. Safety outcomes include the proportion of patients with pulmonary oedema during transport to hospital and on initial chest X-ray and the proportion of patients with anaphylaxis or suspected allergic reactions to study medication.

This study has been approved through Clinical Trials Ontario’s streamlined ethics review process (board of record, Sunnybrook Health Sciences Centre). It will be conducted in accordance with the Declaration of Helsinki, Good Clinical Practice guidelines and regulatory requirements. The final results will be disseminated to participating paramedic services through educational materials, presentations and interactive training. We anticipate our trial will achieve wide dissemination through publication in a peer-reviewed medical journal and presentation at international conferences targeting the fields of prehospital and emergency medicine, resuscitation and critical care.

NCT03068741.

To determine whether an enhanced community rehabilitation intervention (the Fracture in the Elderly Multidisciplinary Rehabilitation (FEMuR) intervention) was more effective than usual National Health Service care, following surgical repair of hip fracture, in terms of the recovery of activities of daily living (ADLs).

Definitive, pragmatic, multisite, parallel-group, two-armed, superiority randomised controlled trial with 1:1 allocation ratio.

Participant recruitment in 13 hospitals across England and Wales, with the FEMuR intervention delivered in the community.

Patients aged over 60 years, with mental capacity, recovering from surgical treatment for hip fracture and living in their own home prior to fracture.

Usual rehabilitation care (control) was compared with usual rehabilitation care plus the FEMuR intervention, which comprised a patient-held workbook and goal-setting diary to improve self-efficacy, and six additional therapy sessions delivered in-person in the community, or remotely during COVID-19 restrictions (intervention), to increase the practice of exercise and ADL.

Primary outcome was the Nottingham Extended Activities of Daily Living (NEADL) scale at 12 months. Secondary outcomes included: Hospital Anxiety and Depression Scale, Falls Self-Efficacy-International scale, hip pain intensity, fear of falling, grip strength and Short Physical Performance Battery. Outcomes were collected by research assistants in participants’ homes, whenever possible, but had to be collected remotely during COVID-19 restrictions.

In total, 205 participants were randomised (n=104 experimental; n=101 control). Trial processes were adversely affected by the COVID-19 pandemic. There were 20 deaths, 34 withdrawals and three lost to follow-up. At 52 weeks, there was no significant difference in NEADL score between the FEMuR intervention and control groups. Joint modelling analysis testing for difference in longitudinal outcome adjusted for missing values also found no significant difference with a mean difference of 0.1 (95% CI –1.1, 1.3). There were no significant between-group differences in secondary outcomes. Sensitivity analyses, examining the impact of COVID-19 restrictions, produced similar results. A median of 4.5 extra rehabilitation sessions were delivered to the FEMuR intervention group, with a median of two sessions delivered in-person. Instrumental variable regression did not find any effect of the amount of rehabilitation on the main outcome. There were 53 unrelated serious adverse events (SAEs) including 11 deaths in the control group: 41 SAEs including nine deaths in the FEMuR intervention group.

The FEMuR intervention was not more effective than usual rehabilitation care. The trial was severely impacted by COVID-19. Possible reasons for lack of effect included limited intervention fidelity (fewer sessions than planned and remote delivery), lack of usual levels of support from health professionals and families, and change in recovery beliefs and behaviours during the pandemic.

ISRCTN28376407.

To monitor the safety and utilisation of AZD1222 under real-world use in the UK.

A non-interventional post-authorisation active surveillance study.

Vaccination sites in the UK.

A total of 17 945 participants were eligible and provided consent to participate in the study between 1 March 2021 and 6 April 2023. Participants were followed up at weeks 1, 4 and 14 and at months 6, 9, 12 and 18 after the first dose of AZD1222 vaccination and prompted to complete electronic data capture forms. A total of 11 219 participants submitted a Follow-Up 1 form and 5189 participants submitted a Follow-Up 7 form (at 18 months).

The safety of AZD1222, including the identification, assessment and quantification of serious adverse events (SAEs) and adverse events of special interest (AESI), was examined. The utilisation of AZD1222 was described and characterised, including populations with missing information.

The majority of participants were women (n=10 845; 60.4%) and the median age (IQR) was 50 (43, 62) years. Most participants were from white ethnic groups (n=13 112; 73.1%). Headache and fatigue had the highest reported incidence rate (421.28 cases per 1000 person years and 386.00 cases per 1000 person years, respectively). The most frequently reported AESI was anosmia (6.25 cases per 1000 person years). An increased Observed versus Expected (O:E) ratio was seen for anaphylaxis (O:E 7.38 (95% CI 2.80 to 11.95); based on 10 observed cases (expected cases: 1.36)) and anosmia and/or ageusia (O:E 39.23 (95% CI 29.13 to 49.32), based on 58 observed cases (expected cases: 1.48)).

The most frequent vaccinee-reported adverse events (AEs) were headache and fatigue. An increased O:E ratio was seen for the AEs of anaphylaxis and anosmia and/or ageusia. No safety signals were identified throughout the course of this study.

This study is registered with the HMA-EMA Catalogue of RWD studies (EUPAS44035).

There have been previous initiatives to identify key performance indicators (KPIs) for continuous kidney replacement therapy. However, no formal reviews of the evidence for KPIs of intermittent kidney replacement therapy (IKRT) have been conducted. This systematic review will appraise the evidence for KPIs of IKRT in critically ill patients and is part of the DIALYZING WISELY (NCT05186636) programme which aims to improve the performance of acute renal replacement therapy in intensive care units by aligning local practices with evidence-based best practices.

Ovid MEDLINE, Ovid Embase, CINAHL and Cochrane Library will be searched for studies involving KPIs for IKRT. Grey literature will also be searched and include technical reports, practice guidelines and conference proceedings as well as websites of relevant organisations. We will search the Agency of Healthcare Research and National Quality Measures Clearinghouse for IKRT-related KPIs. Studies will be included if they contain KPIs, occur in critically ill patients and are associated with IKRT. We will evaluate the risk of bias using the modified Cochrane tool and certainty of evidence using the Grading of Recommendations, Assessment, Development and Evaluations methodology. The analysis will be primarily descriptive. Each KPI will be evaluated for importance, scientific acceptability, usability and feasibility using the four criteria proposed by the United States Strategic Framework Board for a National Quality Measurement and Reporting System. Finally, KPIs will be appraised for potential operational characteristics, potential to be integrated into electronic medical records, adoptability by stakeholders and affordability, if applicable.

Ethics approval is not required as primary data will not be collected. Findings of this review will be disseminated through peer-related publication.

CRD42022074444.

Research indicates the effectiveness of participatory interventions to address rapid rises in type 2 diabetes in low-income countries. Understanding their transferability to different contexts is a priority. We aimed to analyse how the COVID-19 post-lockdown context and adjustments to a participatory learning and action intervention affected theorised mechanisms of effect in rural Bangladesh and to examine the broader implications of this context and intervention adjustments for developing optimal contexts for participatory interventions.

Mixed methods using longitudinal qualitative and quantitative observation data, focus group discussions and interviews with group and community members and project personnel. We used descriptive content analysis, guided by realist evaluation research questions about context, implementation and mechanisms. We used team reflection to enhance the rigour of our analysis.

Cluster-randomised trial in Alfadanga upazila, Faridpur district, in the central region of Bangladesh. The intervention was implemented between January 2020 and December 2022, during the COVID-19 pandemic.

Participatory group members, community members and project personnel (n=32). Structured observations of participatory groups (n=1820) and unstructured observations of groups and their environments (n=15).

Participatory learning and action community groups of men and women implemented by community-based facilitators.

Due to COVID-19, the participatory learning and action (PLA) intervention was not implemented as planned, which had major effects on the time available to develop the intervention with communities. Communities learnt about diabetes and were motivated to address its causes at an individual level, but community action was a more challenging mechanism to trigger. The post-pandemic context made it difficult to build community rapport, and strategies to engage communities through home visits were challenging. Communities’ prior negative experience in working together and in working with non-governmental organisations led to low community cohesion and low motivation to address diabetes collectively. This also resulted in expectations that the implementing organisation would implement community actions and incentivise attendance at meetings. This misalignment of expectations further disabled relationship building, and community strategies addressing the social causes of diabetes were largely not enacted.

PLA has optimal effects when time is available to build trust and social cohesion. These are contextual elements and mechanisms that need to be activated to enable critical reflection and community action to develop an enabling environment to address type 2 diabetes.

ISRCTN42219712.