Existing psychological and pharmacological interventions for young people at ultra-high risk (UHR) for psychosis have shown benefit in at least delaying the transition to psychosis, but they have limited benefit for comorbid disorders or social dysfunction, which are prominent for those at UHR. We developed a moderated online social therapy platform (named Momentum) including: (1) transdiagnostic therapeutic interventions targeting social functioning, depression, generalised anxiety and social anxiety; (2) a moderated, peer-led online community and (3) specialised human support from clinicians, career consultants and peer workers. The aim of this trial is to determine whether, in addition to treatment as usual (TAU), Momentum, a 12-month digital intervention, informed by the complex intervention framework, is superior to 12 months of TAU in improving social functioning in UHR young people.
The study design is a prospective, parallel group, rater-masked randomised controlled trial. We will recruit young people aged 14–27 years, meeting one or more UHR for psychosis criteria. Participants are randomly assigned to the condition using randomly permutated blocks with a 1:1 allocation ratio. Participants are stratified by age (
Melbourne Health Human Research Ethics Committee (HREC/42964/MH-2018) provided ethics approval for this study. Findings will be made available through scientific journals and forums and to the public via social media and the Orygen website. De-identified individual participant data will be available after publication for 3 years via the Health Data Australia catalogue (https://www.researchdata.edu.au/health). Requests must include a methodologically sound proposal. Specific conditions of use may apply and will be specified in a data sharing agreement (or similar) that the requester must agree to before access is granted. Supplementary material including study protocol, informed consent material and statistical analysis plan will also be available.
Australian New Zealand Clinical Trial Registry (ANZCTR), ACTRN12619001411134.
Essential care partners (ECPs), also known as family caregivers, play a critical role in the Canadian healthcare system across the continuum of care, particularly in managing complex conditions like stroke. With the rising number of stroke incidents occurring in Canada each year, there is an increased need for caregiver assistance to help manage the care needs of stroke survivors as they transition to home and community services. Although existing research has highlighted the practical and psychosocial needs of stroke ECPs, these challenges have been mainly overlooked. The lack of integrated intersectoral care services across stroke care pathways places additional significant burdens on caregivers, leading to increased stress, social isolation and a decreased quality of life. Nelson and colleagues’ novel Discharge Assistance and Supports at Home model uses community-based interventions mobilised through intersectoral partnerships and volunteers as human resources to facilitate grassroots solutions to the discharge and transition challenges often faced by stroke survivors. As an extension of this work, this rapid review will investigate and detail community-involved or community-led interventions that have been proven effective in addressing the unmet needs of stroke ECPs during critical care transitions. The findings of this review will identify what works, for whom and in what context regarding community-involved caregiver-centred transition interventions to inform the creation of an actionable Research Agenda—DASH-Caregiver.
This rapid review will be conducted using the updated guidance on methods used in Cochrane rapid reviews of effectiveness. The search strategy will be refined by the study team with assistance from an information specialist and applied to six databases: Medline, Cochrane, Embase, CINAHL and PubMed. Grey literature will be searched using Google search engines, targeted websites and consultation with knowledge holders. Two research team members will conduct a two-stage screening process to determine study eligibility. Data from eligible studies will be extracted using a piloted charting form and synthesised narratively.
This review protocol does not require ethics approval, as no data have been collected or analysed. The results will be shared with key knowledge holders through publications and presentations and incorporated into the team’s future research.
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).
HIV pre-exposure prophylaxis (PrEP) is an effective HIV prevention tool, reducing infection risk by up to 99% when used as prescribed. Despite its proven efficacy, PrEP uptake remains suboptimal, particularly among high-risk populations in Canada. Barriers to access and uptake, including stigma, financial constraints and healthcare accessibility, persist, highlighting the need for targeted interventions. The objective of this scoping review is to identify and map the extent and types of interventions, programmes, practices and policies aimed at increasing the acceptance, access, uptake and sustained use of HIV PrEP in Canada.
This review will use the Joanna Briggs Institute (JBI) Scoping Review methodology. Databases to be searched are MEDLINE, Embase, PsycINFO, Cochrane Library, CINAHL, Scopus and Web of Science from 2016 onwards. Two independent reviewers will screen studies, based on the inclusion criteria. The search results will be presented in a Preferred Reporting Items for Systematic Reviews and Meta-Analyses flow diagram. Data will be extracted from relevant studies by two independent reviewers and summarised to inform future research and policy development. This review will include studies focusing on individuals in Canada who are eligible for or using PrEP for HIV prevention. The interventions considered will address the awareness, acceptance, access, uptake and sustained use of PrEP. Studies must be set within the Canadian context, considering geographic, cultural and systemic factors. Exclusions include studies conducted outside Canada or those not addressing HIV prevention interventions.
This research will rely exclusively on previously published data and will not include human participants. Therefore, ethics approval is not required. For further clarification, please contact Stephen Hwang, Director, MAP Centre for Urban Health Solutions, Unity Health Toronto, at
The protocol has been registered with Open Science Framework at https://doi.org/10.17605/OSF.IO/C7S4Z.
The use of invasive life support in patients with a prolonged critical illness clearly saves lives but carries substantial risks, including intensive care unit-acquired weakness (ICUAW) and long-term disability. Early mobilisation might improve outcomes, yet the evidence is conflicting and complicated by the lack of a responsive outcome measurement to detect change in critically ill patients’ physical function and activity. The Chelsea Critical Care Physical Assessment tool (CPAx) is a valid and reliable instrument for patients at risk of ICUAW. However, its ability to measure change over time (responsiveness) and the minimal clinically important difference (MCID) have not yet been rigorously investigated.
The primary objective of this prospective, international, multicentre, longitudinal cohort study is to investigate responsiveness and to establish the MCID of the CPAx during the ‘intensive care unit (ICU) period’, from ICU baseline to ICU discharge, and ‘hospital period’, from ICU to hospital discharge. Adults with any critical illness who are mechanically ventilated for at least 72 hours, expected to remain in ICU (≥48 hours) and being treated by a physiotherapist are eligible for study inclusion. Functional measurements, including the CPAx and a global rating of change (GRC) scale, will be collected during routine physiotherapy. Responsiveness will be evaluated primarily using the GRC as an anchor to distinguish changed from unchanged/deteriorated patients (criterion validity). As such, the magnitude of change will be analysed with receiver operating characteristics. Additionally, construct validity will be explored with correlation coefficients and effect sizes to confirm/reject a priori formulated hypotheses. MCID will be investigated with anchor-based and distribution-based methods. We plan to recruit 120 patients across three sites in Australia and Switzerland.
Ethical approval has been obtained from each local ethics committee (Canton of Bern, Switzerland (2024-00346), Monash Health, Australia (HREC/106143/MonH-2024-438474(v3)), the Alfred, Australia (490/24)). The results will be disseminated through international/national conferences, peer-reviewed journals and social media. The high quality, rigorous testing of the CPAx could benefit researchers, clinicians and patients.
Recent legislation in the UK regarding requirements for new developments to increase biodiversity may have significant implications for the environment and population health. Despite this, relatively little is known regarding the health and social benefits of increasing biodiversity in densely populated urban areas.
This protocol outlines plans for a mixed-method, longitudinal, natural experiment study which will evaluate the planned, biodiversity-focused redevelopment of six small urban parks in Edinburgh, Scotland (UK). Using systematic observation (at baseline, 1 month post-intervention and 1 year post-baseline) and a longitudinal household survey (at baseline and 1 year post-baseline), the primary outcomes of personal well-being, and secondary outcomes of nature connectedness and park usage behaviours, will be assessed, respectively. Consent for data linkage of respondent’s health records will also be sought. Process evaluation will employ semi-structured, qualitative interviews with stakeholders and walk-along interviews with local residents in order to understand implementation processes. Space-related well-being will also be assessed using citizen science approaches.
This study was approved by the University of Edinburgh’s School of Health in Social Sciences ethics committee. This study will provide further evidence for policymakers, the public and researchers of the health and social well-being effects of urban biodiversity interventions. Study findings will be disseminated via public forums such as community workshops and through publication in peer-reviewed journals and presentation at scientific conferences.
We calculate positive predictive values (PPVs) of patients presenting with unexpected weight loss (UWL) being diagnosed with cancer within 6 months, using data from a population of Australian primary care patients to replicate results from a previous UK study.
A diagnostic accuracy study involving calculation of the PPV for any cancer using retrospective data from routinely collected electronic healthcare records. The index date is defined as the first recorded UWL presentation and the reference standard is cancer diagnosis within 6 months of the index date.
This study uses primary care data from the Patron primary care database, linked to hospital admissions data and the Victorian Cancer Registry. We include only patients who presented to their General Practitioners (GPs) at least once between 1 July 2007 and 1 February 2022.
Patients were included if they were at least 18 years of age at the index date, had no previous diagnosis of cancer or previous weight loss intervention, including being prescribed medications for weight loss. 13 306 patients out of a primary care population of 1 791 051 patients were identified that met the eligibility criteria.
When stratified by age, sex and smoking status, we found PPVs lower than those derived in a previous UK primary care study, though still above 3% for male non-smokers over 60, female smokers over 70 and all males over 70. Patients from ages 60–79 with at least one abnormal blood test result had PPVs consistently above 3%, while overall, patients with abnormal blood test results have PPVs of up to 35%.
We confirmed that many PPVs, while consistently below those derived in the UK study, are above clinically significant thresholds and increasing with age and the number of different abnormal blood test results.
Despite extensive efforts in HIV prevention, significant barriers to accessing interventions such as HIV pre-exposure prophylaxis (PrEP) persist in Canada. Although PrEP has demonstrated efficacy in preventing HIV transmission, various structural, social and systemic factors continue to impede its widespread adoption and use. These factors influence the uptake (acceptance and access) and use (adherence and retention) of PrEP. The purpose of this scoping review is to examine the existing body of evidence regarding the barriers and facilitators to uptake and use of PrEP in Canada. By identifying these factors, the review aims to inform future research, policy development and interventions to improve PrEP access and its integration into HIV prevention strategies in Canada.
This scoping review will focus on studies involving HIV-seronegative individuals in Canada who are either eligible for or currently using PrEP as an HIV prevention option. The review will consider barriers and facilitators within services, programmes, policies or practices related to HIV prevention in Canada. Eligible studies will include experimental, quasi-experimental, observational or qualitative designs. Studies that do not address PrEP or HIV prevention, or that involve populations not aligned with the inclusion criteria, will be excluded. The review will involve searching a range of key databases, including MEDLINE, Embase, PsycINFO, Cochrane Library, CINAHL, Scopus, Web of Science and TRIP, with no language restrictions, and focusing on publications from 2016 onward. Two independent reviewers will screen titles and abstracts, followed by full-text assessment and data extraction, using Covidence. Data will be analysed narratively, with a specific focus on subgroup analyses of key populations. The findings will be synthesised to provide an overview of the key themes, trends, and evidence gaps identified within the existing literature.
This piece of research will not involve human participants and will solely use already published data. Consequently, ethics approval is not necessary. The findings will be disseminated through peer-reviewed journal articles and conference presentations and may be of relevance to governmental health agencies and local HIV/AIDS service organisations.
The protocol has been registered on Open Science Framework registries at https://doi.org/10.17605/OSF.IO/69WJA.