Selecting an optimal initial dosage of opioid agonist treatment (OAT) balances effectiveness and safety, as initial doses that are too low may be insufficient, potentially prompting clients to seek unregulated drugs to alleviate withdrawal symptoms, which may increase the likelihood of treatment discontinuation. Conversely, initial doses that are too high carry a risk of overdose. As opioid tolerance levels have risen in the fentanyl era, linked population-level data capturing initial doses in the real world provide a valuable opportunity to refine existing guidance on optimal OAT dosing at treatment initiation. Our objective is to determine the comparative effectiveness of alternative initial doses of methadone, buprenorphine-naloxone and slow-release oral morphine at OAT initiation, as observed in clinical practice in British Columbia (BC), Canada.

We propose a population-level retrospective observational study with a linkage of nine provincial health administrative databases in BC, Canada (1 January 2010 to 31 December 2022). Our study includes two time-to-event primary outcomes: OAT discontinuation and all-cause mortality during follow-up. We propose ‘initiator’ target trial analyses for each medication using both propensity score weighting and instrumental variable analyses to compare the effect of different initial OAT doses on the hazard of time-to-OAT discontinuation and all-cause mortality. A range of sensitivity analyses will be used to assess the robustness of the results.

The protocol, cohort creation and analysis plan have been classified and approved as a quality improvement initiative by Providence Health Care Research Ethics Board and the Simon Fraser University Office of Research Ethics. Results will be disseminated to local advocacy groups and decision-makers, national and international clinical guideline developers, presented at international conferences and published in peer-reviewed journals electronically and in print.

While group, task-oriented, community-based exercise programs (CBEPs) delivered in-person can increase exercise and social participation in people with mobility limitations, challenges with transportation, cost and human resources, threaten sustainability. A virtual delivery model may help overcome challenges with accessing and delivering in-person CBEPs. The study objective is to estimate the short-term effect of an 8-week, virtual, group, task-oriented CBEP called TIME™ (Together in Movement and Exercise) at Home compared with a waitlist control on improving everyday function in community-dwelling adults with mobility limitations.

A randomised controlled trial incorporating a type 1 effectiveness-implementation hybrid design is being conducted in four Canadian metropolitan centres. We aim to stratify 200 adults with self-reported mobility limitations by site, participation alone or with a partner, and functional mobility level, and randomise them using REDCap software to either TIME™ at Home or a waitlist control group. During TIME™ at Home classes (2 classes/week, 1.5 hours/class), two trained facilitators stream a 1-hour exercise video and facilitate social interaction prevideo and postvideo using Zoom. A registered healthcare professional at each site completes three e-visits to monitor and support implementation. Masked evaluators with physical therapy training evaluate participants and their caregivers at 0, 2 and 5 months using Zoom. The primary outcome is the change in everyday function from 0 to 2 months, measured using the physical scale of the Subjective Index of Physical and Social Outcome. The study is powered to detect an effect size of 0.4, given α=0.05, power=80% and a 15% attrition rate. Secondary outcomes are mobility, well-being, reliance on walking aids, caregiver assistance, caregiver mood, caregiver confidence in care-recipient balance and cost-effectiveness. A multimethod process evaluation is proposed to increase understanding of implementation fidelity, mechanisms of effect and contextual factors influencing the complex intervention. Qualitative data collection immediately postintervention involves interviewing approximately 16 participants and 4 caregivers from the experimental group, and 8 participants and 4 caregivers from the waitlist control group, and all healthcare professionals, and conducting focus groups with all facilitators to explore experiences during the intervention period. A directed content analysis will be undertaken to help explain the quantitative results.

TIME™ at Home has received ethics approval at all sites. Participants provide verbal informed consent. A data safety monitoring board is monitoring adverse events. We will disseminate findings through lay summaries, conference presentations, reports and journal articles.

NCT06245135.

Health advocacy (HA) is acknowledged as a core competence in medical education. However, varying and sometimes conflicting conceptualisations of HA exist, making it challenging to integrate the competence consistently. While this diversity highlights the need for a deeper understanding of HA conceptualisations, a comprehensive analysis across the continuum of medical education is absent in the literature. This protocol has been developed to clarify the conceptual dimensions of the HA competence in literature as applied to medical education.

The review will be conducted in line with the JBI (formerly Joanna Briggs Institute) methodology for scoping reviews. A comprehensive literature search was developed and already carried out in eight academic databases and Google Scholar, without restrictions on publication date, geography or language. Articles that describe the HA role among students and physicians who receive or provide medical education will be eligible for inclusion. Two independent reviewers will independently complete title and abstract screening prior to full-text review of selected articles and data extraction on the final set. A descriptive-analytical approach will be applied for summarising the data.

This scoping review does not involve human participants, as all evidence is sourced from publicly available databases. Therefore, ethical approval is not required for this study. The findings from this scoping review will be disseminated through submission to a high-quality peer-reviewed journal and presented at academic conferences. By clarifying the conceptualisations of HA, this review aims to contribute to a shared narrative that will strengthen the foundation for integrating the HA role into medical education.

A preliminary version of this protocol was registered on the Open Science Framework on 9 December 2024, and can be accessed at the following link: https://osf.io/ed2br. We have also registered our scoping review protocol as a preprint at medRxiv: https://doi.org/10.1101/2024.12.09.24318699.

Methadone and buprenorphine/naloxone are effective medications for people with opioid use disorder; however, interruptions in daily dosing are common and diminish the benefits of these medications. While clinical guidelines in most North American jurisdictions, including British Columbia (BC), recommend dose adjustment after treatment interruptions to varying levels of specificity, the evidence to support these recommendations is limited. We aim to estimate the comparative effectiveness of alternative dose adjustment strategies on subsequent overdose-related acute care visits and discontinuation of opioid agonist treatment in BC, Canada.

Using a linkage of nine health administrative databases, we propose a population-level retrospective cohort study of adults aged 18 years or older in BC who initiated methadone or buprenorphine/naloxone between 1 January 2010 and 31 December 2022. We will specify parallel hypothetical trials, known as target trials, for methadone interruptions of 1–3 days, 4 days and 5–14 days, and buprenorphine/naloxone interruptions of 1–5 days and 6–14 days. Following the index interruption, the primary outcomes are the time to overdose-related acute care visits and treatment discontinuation (interruptions lasting >14 days), with time to all-cause acute care visits as a secondary outcome. The intention-to-treat effect will be estimated using both propensity score and instrumental variable approaches. A range of sensitivity analyses will assess the robustness of our results, including cohort and timeline restriction, alternative definitions of exposure and outcome and alternative estimation strategies.

The protocol, cohort creation and analysis plan have been classified and approved as a quality improvement initiative by Providence Health Care Research Institute and the Simon Fraser University Office of Research Ethics. All data are deidentified, securely stored and accessed in accordance with provincial privacy regulations. Results will be disseminated to local advocacy groups and decision-makers, national and international clinical guideline developers, presented at international conferences and published in peer-reviewed journals electronically and in print.

During the COVID-19 pandemic, a substantial decrease was observed in hospital admissions and in-hospital procedures for patients with acute cardiovascular diseases (CVDs). The extent to which measures to prevent COVID-19 transmission, for example, lockdowns, affected the outpatient care of patients at higher cardiovascular risk remains unclear. We aimed to compare outpatient department (OPD) attendance, cardiovascular risk management (CVRM) and cardiovascular health (CVH) of patients at higher cardiovascular risk referred to an OPD of a tertiary care centre between preCOVID-19, during and postCOVID-19 periods.

We included all adult patients at higher cardiovascular risk referred to the cardiology, vascular medicine, diabetology, geriatrics, nephrology or multidisciplinary vascular surgery OPDs of the University Medical Centre Utrecht, the Netherlands, between March 2019 and December 2022, in a prospective cohort study.

We assessed trends in the number of first and follow-up appointments and in the completeness of extractable CVRM indicators from the electronic health record (EHR) as a proxy for CVRM guideline adherence. CVH was determined using the Life’s Essential 8 metric (score 0–100, the higher score, the better). We investigated whether CVH differed between COVID-19 periods compared with the reference period (ie, 2019) and stratified by OPDs, using multivariable linear regression, adjusted for age, gender, CVD history and whether the patient had a previous appointment before the reference period.

Among 15 143 patients, we observed a 33% reduction in the weekly number of first appointments during the COVID-19 pandemic, with the largest reductions in the cardiology and nephrology OPDs, with no differences between women and men. Follow-up appointments conducted remotely, compared with before the COVID-19 pandemic, increased significantly for all OPDs. CVRM indicators were up to 11% less extractable during the first lockdown yet returned to prepandemic levels directly after the first lockdown period. The CVH score of patients visiting the nephrology, vascular medicine and geriatrics OPDs during the first lockdown was 11.23 (95% CI 2.74 to 19.72), 5.68 (95% CI 0.82 to 10.54) and 5.66 (95% CI 0.01 to 11.31) points higher, respectively, compared with the prepandemic period. In between the second and third lockdowns, the CVH score was comparable to the preCOVID reference period, yet for the cardiology OPD it was significantly higher (5.54, 95% CI 2.04 to 9.05).

During the COVID-19 pandemic, weekly numbers of first appointments to OPDs decreased, and a population with a higher CVH score (ie, better CVH) visited certain OPDs, especially during the first lockdown period. These suggest that patients with poorer CVH more often avoided or were unable to visit OPDs, which might have resulted in missed opportunities to control cardiovascular risk factors and potentially may have led to preventable disease outcomes. For future epidemics and pandemics, it seems vital to develop a strategy that includes an emphasis on seeking healthcare when needed, with specific attention to patients at higher CVD risk.

Social norms are often implicit informal rules that most people accept and abide by, and can influence how people behave, sometimes based on perceived rewards and/or sanctions. Social norms are propelled by some reference or population groups who exert a considerable amount of influence on behaviour because people value their approval or disapproval. Despite these observations, little research exists on the influence of social norms on diabetes risk-taking behaviours. We explored diet-related social norms and their influence on risk-taking behaviours for type 2 diabetes (T2D).

We conducted a multi-method qualitative study guided by the Social Norms Exploration Toolkit participatory tools. A total of 45 participants were interviewed for this study, including (10) T2D patients, (10) caregivers of T2D patients, (10) healthcare providers, (2) village health teams, (4) diabetes-free community members; (4) community influencers like cultural leaders and (5) family members. The study was conducted in eastern Uganda in the districts of Bugiri and Busia. Data were collected on health workers, caregivers, patients and community members using focus group discussions, in-depth interviews and non-participant observation. Data were manually analysed to identify emerging social norms and other information of interest following a thematic framework approach.

Most participants were aware that frequent consumption of fatty foods and sugary refined foods could increase one’s risk of getting T2D. The study highlights three themes: general awareness of T2D risk factors, common social norms influencing dietary behaviours and behavioural risk factors that are influenced by the social norms. The study highlights significant behavioural and social drivers of T2D, which include consumption of high-fat, high-sugar diets, limited exercise and stress. Gendered and cultural norms strongly influence dietary behaviours, with women preparing unhealthy foods to meet societal expectations, fearing sanctions like divorce or community stigma, while men’s dietary preferences were linked to respect and social status. Norms around staple food preferences and respect linked to weight further perpetuate T2D risk behaviours. Community influencers, family dynamics and cultural traditions reinforce these practices, underscoring the need for gender-transformative, culturally sensitive and community-centred interventions. However, healthcare providers and village health teams are critical for promoting healthier behaviours and reducing T2D prevalence.

Our deep-dive social norms diagnosis has revealed that even when people know the risk factors for T2D, they will still follow the social norm influence regarding lifestyles. Inclusive strategies that actively engage and reshape norms are therefore vital to reduce the prevalence of T2D.

Alzheimer’s disease and related dementias (ADRD) are conditions with progressive cognitive decline. Still, people living with late-stage ADRD (PLWD) have been reported to exhibit transient recovery of communication or behavioural abilities that had seemingly been lost. These lucid episodes (LEs) are underinvestigated and poorly understood. This study aims to advance scientific understanding of the incidence, prevalence and predictors of LEs and assess from family caregivers if LEs are associated with changes they make in care planning or experiences with burden, distress or grief.

This study recruited 545 caregivers from five ADRD-related registries in the USA. Eligibility included caregivers over 18 years who currently provide care to someone with moderate to very severe ADRD and can complete online questionnaires. Using a longitudinal observational study design, consented caregivers will be assessed monthly for 1 year using online questionnaires that inquire about witnessing LEs. If witnessed, the context and content of the LE is reported. Changes in caregiver decision-making about care for the PLWD, and caregiver burden, distress and grief are assessed at baseline, 6 and 12 months.

Analysis of baseline data will assess descriptive aspects of LEs that are currently unknown (eg, prevalence, content, antecedents, duration). Longitudinal analysis will examine the incidence of LEs, characteristics of PLWD and caregivers that are predictors of episodes, and the associations between LEs and caregiver outcomes (eg, burden, distress, grief).

This study is being conducted in accordance with all Federal Policies for the Protection of Human Subjects. The protocol has been approved by the Mayo Clinic Institutional Review Board (ID 22-006861). Findings will be presented at scientific conferences and disseminated through journal publications and outreach efforts with collaborating partners invested in brain health and caregiver support.

Severe intraventricular haemorrhage (IVH) and white matter injury (WMI) are major neurological complications in preterm infants, leading to long-term neurodevelopmental impairments. Despite advances in neonatal care, effective treatments are lacking. Umbilical cord blood cell (UCBC) therapy shows neuroprotective potential, with autologous sources ideal but often not feasible due to the unpredictability of preterm births. Allogeneic UCBCs offer an alternative, although immunogenicity and human leucocyte antigen (HLA) compatibility present challenges with knowledge gaps in their relevance in neonatal populations. This study aims to assess the feasibility and safety of partially HLA-matched allogeneic UCBC therapy in preterm infants with severe brain injury.

The ALLO trial is an open-label, phase I, single-arm feasibility and safety study conducted at Monash Children’s Hospital, Victoria, Australia. Preterm infants born before 28 weeks (ALLO-1) or between 28 weeks and 36+6 weeks (ALLO-2) gestational age with severe brain injury identified on neuroimaging will be enrolled. Severe brain injury is defined as grade 3 or 4 IVH or significant WMI. Exclusion criteria include major congenital anomalies or redirection to comfort care. Eligible infants will receive a single intravenous infusion of unrelated, allogeneic, partially HLA-matched (4/6 or 5/6 HLA match) UCBCs sourced from a public cord blood bank. The target dose is 50 million total nucleated cells per kilogram body weight. Infusion will occur within 2–3 weeks of confirmation of eligibility, contingent on clinical stability and absence of active sepsis. Primary outcome includes: (1) feasibility, defined as having more than 60% of enrolled infants with an eligible allogeneic partially matched cord blood unit available and (2) safety, defined as absence of severe adverse events within 48 hours of infusion or graft-versus-host disease within 3 months of infusion. Secondary outcomes include survival, neonatal morbidities, neurodevelopmental assessments and serum cytokine analysis.

Monash HREC has granted full ethics approval (RES-23-0000-297A) for the study, including the research use of allogeneic cord blood from compassionate donations by healthy donors, facilitated through the Bone Marrow Donor Institute Cord Blood Bank within the AusCord network. Findings will be disseminated through peer-reviewed publications and conference presentations, contributing to the development of novel neuroreparative therapies for preterm brain injury.

ACTRN12623001352695 (The Australian New Zealand Clinical Trials Registry).