On 1 January 2023, Ontario expanded pharmacists’ scope of practice, allowing them to prescribe medications for 13 minor ailments, including antibiotics for uncomplicated urinary tract infections (UTIs) and Lyme disease (LD) prophylaxis. This study evaluates pharmacist billing claims and pharmacist and physician antibiotic-prescribing rates before and after policy implementation.

An interrupted time series analysis measuring changes in prescribing trends post-implementation.

This retrospective study analysed visit claims and antibiotic prescribing for UTIs and LD prophylaxis before policy implementation (2022) and after (2023–2024) in Ontario.

Data from Ontarians

Prescribing rates were standardised per 1000 inhabitants, stratified by provider type, patient age and sex, and antibiotic type.

In 2023 and 2024, pharmacists submitted over 1.47 million minor ailment claims, with UTIs making up 34.2% and LD prophylaxis making up 2.6% of total claims. UTI claims were primarily for women aged 25–64, and LD prophylaxis peaked in spring and fall. Pharmacist prescribing of eligible urinary drugs in females increased by 33.3 per 1000 person-years (95% CI 30.8 to 36.6) while physician prescribing decreased by 23.3 (95% CI –32.2 to –15.3), leading to a modest net increase of 10.1 (95% CI 0.0 to 18.7). Pharmacist prescribing of doxycycline was offset by decreased physician prescribing, resulting in no change (0.0, 95% CI –1.0 to 0.9). Pharmacist prescribing for other antibiotics was low over the study timeframe, while physician prescribing increased, which was driven by increased prescribing of penicillins and macrolides.

There was a clear increase in pharmacist prescribing for eligible drugs in the eligible population post-policy implementation. Pharmacists in Ontario appear to be prescribing within policy limits for uncomplicated UTIs and LD prophylaxis.

Harms due to methamphetamine use disorder (MAUD) are rising globally. Untreated withdrawal symptoms perpetuate the cycle of dependence and are a barrier to treatment. There is no pharmacotherapy approved for methamphetamine withdrawal. Lisdexamfetamine (LDX) dimesylate has potential as an agonist therapy to ameliorate symptom severity during acute methamphetamine withdrawal and increase duration of initial abstinence and retention in treatment.

We will conduct a double-blind, randomised, controlled trial to evaluate the efficacy of LDX in reducing symptom severity during acute methamphetamine (MA) withdrawal. One hundred eighty-four adults with moderate to severe MAUD presenting to a health service requesting MA withdrawal treatment who report use of MA within the last 72 hours will be recruited. Participants will be randomised 1:1 to receive a tapering dose of lisdexamfetamine (250 mg on day 1, reducing by 50 mg per day to 50 mg on day 5, followed by 2 days of placebo washout on days 6 and 7), or placebo for 7 days. The study will be conducted over 7 days in an inpatient unit, and all participants will also receive standard inpatient withdrawal care. Participants will be followed up in the community to day 84. The primary outcome is efficacy, defined as the between-group difference in average withdrawal severity measured over the 7-day admission by the Amphetamine Withdrawal Questionnaire. Secondary outcomes are retention in treatment, treatment satisfaction, sleep and concomitant medication use (symptomatic medications and medications for other indications to day 7); safety, craving for MA, post-treatment withdrawal symptoms, depression, anxiety and stress, insomnia and cost effectiveness (to day 28) and MA use, mental, physical and social health and post-withdrawal treatment utilisation (to day 84). A First Nations qualitative substudy will assess the experiences of Aboriginal and Torres Strait Islander participants, ensuring the treatment meets the needs of First Nations people.

This protocol was first approved by the St Vincent’s Hospital Human Research Ethics Committee on 15/05/2024 (2024/ETH00788). All participants will be provided with a participant information sheet and consent form, be fully informed about the study and given ample time to consider participation. Results will be published in peer-reviewed journals and presented at national and international conferences. Findings will be presented such that individual participants will not be identifiable.

ACTRN12624001061527.

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.

ISRCTN74668529.

This project explores the feasibility of setting up a neuropsychiatric de-identified database (DiD) and a Research Register (RR) to collect, analyse, monitor and systematically report clinical data for people with intellectual disabilities (PwIDs) and epilepsy.

A multicentre project designed to collect de-identified data from clinical records at three adult ID specialist services in England and Wales and to develop an RR of PwID and epilepsy. Patients added to the DiD will be identified from patient clinic lists, clinic letters, in-house databases and electronic systems. Patients to be added to the RR will also be identified through attendance for regular review at clinic appointments. The collected data will be entered into the Research Electronic Data Capture (REDCap) database. Personal details of PwID and their consultees will also be collected from participants who consent to be on the RR. Around 600 PwID and epilepsy (200 per site) will be added to the DiD at the three sites, while around 45–60 participants (15–20 per site) are anticipated to be added to the RR. Data analysis will involve using descriptive statistics to summarise feasibility outcomes, such as screening and recruitment rates, as well as the completeness of the collected data. The characteristics of the participants (demographic, ID classification, clinical, epilepsy history and antiseizure medication) will be summarised descriptively. Progression will be assessed using the Red/Amber/Green stop-go criteria to determine if a national register should be created.

Ethical approval (24/NW/0210) has been obtained from the Northwest-Haydock Research Ethics Committee and the University of Plymouth Faculty Research Ethics and Integrity Committee (reference no. 5284). The project is funded by Jazz Pharmaceuticals as an independent investigator-initiated support grant and, as such, has received independent peer review.

NCT06780501.

Worldwide, there are 15 established trauma databases collecting data to better understand the patterns of injury and effectiveness of interventions, but interpreting the information is hampered by the varied approaches. The aim of this study was to determine the impact, practices, evolution in design and methods of analysis that are standardised and comparable within registries.

A thematic analysis using a narrative synthesis was used to develop threads for future study and identify the limitations in current practice.

PubMed, Ovid, Scopus and EMBASE were searched on the 2 October 2025. At the same time, ChatGPT (Open artificial intelligence) identified the most cited articles in orthopaedic trauma registries, cross-referencing lists as a form of triangulation to aid in snowballing references.

The review included 174 papers from trials and observational studies that analyse data from established trauma orthopaedic registries published in English.

Two independent reviewers used standardised methods to search, screen and code included studies assessing the papers using the Strengthening the Reporting of Observational Studies in Epidemiology checklist to assess the observational and cohort studies and the Downs and Black Quality Criteria for the remaining papers.

Outcome measures other than mortality are poorly collected, undermining the value of registries. Trauma patients reported considerable impairment 6 and 12 months after injury. Association between level of trauma care and mortality is evident for major trauma populations, but does not hold for general trauma populations. Level I trauma centres produce improved survival in severely injured, but this association could not be proven for non-fatal outcomes in general populations. There is a disparity between resources allocated to save and salvage cases within major trauma units, and hence, routine cases often have lower priority and delayed care.

There is a need to develop a standardised and reproducible method to evaluate data quality in trauma registries. National performance guidelines and trauma centre audits are integral steps towards optimum results. Routine collection of postinjury outcome measures beyond mortality will enable the development of quality improvement metrics that better reflect patient outcomes.

Individuals with Down syndrome (DS) are predisposed to obstructive sleep apnoea (OSA) due to craniofacial features (eg, midface hypoplasia, glossoptosis) and studies have shown that the prevalence of OSA in this population is markedly increased compared with that of typically developing children. Adenotonsillectomy is considered the first-line treatment for childhood OSA. However, persistent OSA is common, thus many children with DS are referred for positive airway pressure (PAP) therapy initiation; PAP appears to be an important aspect of living with DS. PAP has been shown to be highly effective in the general population for treating OSA and improving OSA-associated neurobehavioural symptoms, such as quality of life, behaviour, mood, daytime sleepiness and school performance. However, PAP as a treatment for OSA has not been well-studied in children with DS. Therefore, we designed a multicentre randomised controlled trial recruiting children with DS and OSA at three academic institutions, aged 6–18 years, referred for PAP initiation to treat OSA.

86 participants will be randomised to a 6-month intensive behavioural intervention (INT) to improve PAP adherence versus standard clinical care and underwent standardised evaluations of quality of life, behaviour, attention, PAP adherence and healthcare utilisation at baseline, 6 months and 12 months.

This study has been approved by the institutional review board at Children’s Hospital of Philadelphia (IRB of record, IRB # 20–0 17 512). Cincinnati Children’s Medical Center and University of Miami delegated IRB review and approval responsibility to Children’s Hospital of Philadelphia through reliance agreements as mandated by National Institutes of Health (NIH). All participants will be minors; consent will be obtained from parents and assent from participants will be obtained when possible. The intervention tested in this trial is considered not greater than minimal risk, and no identifiable data will be reported. As required by the NIH, a data safety monitoring board (DSMB) has been formed, who will review and approve the protocol and any protocol changes prior to implementation. The study team will send biannual reports and hold a biannual meeting with the DSMB to review any safety and protocol concerns. Findings will be presented at national conferences pertinent to this topic and published in peer-reviewed medical journals. In addition, findings will be shared in the lay format with DS associations around the world and used for training of healthcare providers and trainees (R25HD118212). Further, data collected will be deposited in a repository (National Sleep Research Resource; sleepdata.org) after completion of the study to maximise use by scientific community.

NCT04132999.

Saskatchewan is facing a public health crisis driven by high rates of HIV, syphilis and hepatitis C virus (HCV) infections, particularly among people who use drugs. Injection drug use is a major contributor to these syndemic infections, exacerbated by structural barriers such as stigma, poverty and limited culturally safe healthcare. Innovative, community-informed approaches are urgently needed to improve prevention, testing and linkage to care.

This study will implement a rapid assessment and response system in Regina, Saskatchewan, Canada, integrating geospatial mapping of community needle prevalence with pop-up interventions. Needle hotspot maps will be used to guide the deployment of community-based pop-up events offering point-of-care testing for HIV, syphilis and HCV, alongside education on pre-exposure prophylaxis (PrEP) and postexposure prophylaxis (PEP). A convergent participatory mixed-methods design will be used to evaluate feasibility, acceptability and effectiveness, guided by the Reach, Effectiveness, Adoption, Implementation and Maintenance framework. Quantitative data will assess changes in knowledge of PrEP and PEP, satisfaction with the intervention and report new diagnoses and participant demographics descriptively. A qualitative substudy will include 30 participants and will explore experiences with the intervention, barriers to care and perceptions of service delivery.

Ethical approval has been obtained from the research ethics board of the Saskatchewan Health Authority (#24–91). Findings will be disseminated through peer-reviewed publications, conference presentations and community reporting. This study may provide a model of community-based geospatial testing and education that could be scaled up and adapted elsewhere.

Open Science Framework https://doi.org/10.17605/OSF.IO/HVK3B

Addressing physical inactivity is a promising dementia risk reduction strategy due to its direct benefits for brain health, and indirect benefits for other modifiable dementia risk factors. A potential limitation of previous interventions is that they often overlook how increasing physical activity affects other behaviours throughout the 24-hour day, such as sleep and sedentary behaviour, which are also important for brain health. Further, interventions are rarely tailored to the individual, considering their needs, preferences and constraints that may serve as barriers or facilitators to behaviour change. The current phase I randomised controlled trial, Small Steps, aims to investigate feasibility, acceptability and preliminary effectiveness of a personalised 24-hour time-use intervention to improve lifestyle and cognitive health in older adults.

Participants aged ≥65 years from Adelaide, South Australia will be recruited and randomised to either the Extended or Condensed programme. During the first 12 weeks, participants in the Extended programme will use a tailored website to set personalised weekly goals to move towards their ‘optimal’ 24-hour day for brain health, facilitated by weekly website ‘check-ins’ and weekly phone calls with a research staff member. Participants randomised to the Condensed programme will have access to the website educational resources only but will not undergo personalised goal setting or telephone calls. Following the introductory phase (first 12 weeks), phone calls will be gradually withdrawn for the Extended programme. Primary (feasibility and acceptability) and secondary outcomes (changes in time use, cognitive function and behaviour change metrics) will be assessed 12, 24 and 36 weeks after the beginning of the intervention.

Ethics approval has been obtained from the University of South Australia’s Human Research Ethics Committee (205989). Study findings will be disseminated through peer-reviewed journal articles, conference presentations, media releases and community engagement.

NCT06291909).

The ROWTATE intervention helps people experiencing trauma to return to work (RTW) through vocational rehabilitation (VR) support from occupational therapists (OTs) and clinical psychologists (CPs). This study aims to explore and understand the acceptability of VR after traumatic injury for patients, therapists and employers.

Qualitative interviews in eight major trauma regions, UK.

Interviews were undertaken with a range of stakeholders—15 patients, 15 therapists and 6 employers. Data were analysed using the theoretical framework of acceptability.

Stakeholders understood the aim of the intervention was to support people to RTW and perceived it as effective in achieving this. Patients and therapists understood the benefits of working with a combination of occupational therapy and clinical psychology. The intervention fits with the values of patients wanting to recover, therapists wanting to offer support and line managers wanting to meet employer and employee needs.

Patients reported they could not have achieved RTW without the intervention, and their therapist helped them feel less alone. Therapists felt that their work was rewarding, effective and had good outcomes. Patients perceived remote delivery as less burdensome than attending in person. Therapists felt they wasted time on non-patient activity, such as (re-)arranging appointments.

Employers discussed the difficulty of balancing employer and employee needs and managing uncertainty. Some workplace policies lacked flexibility, and without the ROWTATE intervention, employers lacked confidence in supporting employees RTW.

A VR intervention delivered remotely by OTs and CPs is acceptable to patients, therapists and employers.

ISRCTN43115471.

Cystic fibrosis (CF) is an inherited condition, affecting approximately 150 000 people worldwide. Physical activity (PA) is an integral component in the management of CF. However, it is estimated that only a third of young people (with and without CF) achieve UK Chief Medical Officer guideline recommended levels of activity. The aim of this research was to use the person-based approach to develop an intervention supporting families with young people (aged 6–12 years) with CF to incorporate PA as a sustainable habit in their lives to increase the likelihood of sustained PA levels going into adolescence and adulthood.

Using the person-based approach, intervention content was created and iteratively adapted. This was initially guided by relevant literature; the guiding principles, logic model and preliminary content were developed via co-production with patient and public involvement (PPI) representatives (n=8) with lived experience of CF. The intervention was further refined/optimised using qualitative think-aloud and retrospective interviews, the results of the preliminary evaluation are reported. Think-aloud interviews were rapidly analysed using a table of changes analysis and used to inform adaptations to content. Retrospective interviews were analysed thematically.

Community settings in the UK.

Participants included six families with a child with CF aged between 6 years and 12 years old.

Intervention content consisted of nine sections and was delivered as a printable PDF file. Informed by the Capability, Opportunity, Motivation and Behaviour framework and self-determination theory, content focused on promotion of PA as a family activity that is fun, enjoyable, quick and achievable. It promoted ‘movement to make you feel good"’ and in short bursts of activity. Promotion of PA as medicine was avoided. The final intervention was considered to be engaging and acceptable.

Qualitative methods and PPI facilitated the development of a family-focused intervention supporting the integration of PA into daily life. This was viewed as acceptable and engaging among families of people with CF. Future research now needs to explore the effectiveness of the intervention for increasing PA behaviour.

To assess the feasibility and acceptability of three SMS-delivered safer gambling interventions (goal setting (GS), descriptive norms (DN), injunctive norms (IN)) aimed at reducing the transition from low or moderate risk of gambling harm to problematic gambling, and the feasibility of a full-scale randomised controlled trial evaluating their effectiveness and cost-effectiveness.

Four-arm, parallel-group, pragmatic, randomised controlled feasibility study with a nested qualitative study.

The study was conducted in the UK. Participants were recruited online via UK-licensed gambling operators’ websites.

Adults aged ≥18 years, gambling online at least weekly, with low-to-moderate gambling risk levels.

Participants were block randomised in equal proportions to a delayed intervention control group or one of three 6-week text message interventions delivered via the secure messaging app WIRE: (1) GS: weekly prompts to set gambling-related goals with personalised feedback; (2) DN: weekly messages challenging misperceptions about peer gambling behaviours and (3) IN: weekly messages addressing misperceptions about peer attitudes towards gambling.

Feasibility was assessed through recruitment and retention rates, intervention adherence, data completeness and feasibility and acceptability of the interventions and study procedures. Secondary outcomes included gambling risk behaviours and cognitions, anxiety, depression, quality of life, healthcare use and productivity, measured at baseline, 7-weeks, and 3- and 6-months post-randomisation.

Recruitment took place between April 2021 and August 2022 with final follow-up in February 2023. 167 participants (mean age 51.5; 36% male) were randomised (GS=43; DN=41; IN=42; Control=41). Retention at 6-months was 95.2%, with >95% completion for all outcome measures. Intervention adherence was high, with >95% of DN and IN participants responding to ≥4 messages and 93% of GS participants setting ≥4 goals. Qualitative findings indicated broad acceptability of the interventions and study procedures.

The study was feasible to conduct, interventions and study procedures acceptable to participants, and predefined progression criteria met. Findings support proceeding to a full-scale randomised controlled trial of effectiveness and cost-effectiveness, focusing on the social norms interventions.

ISRCTN37874344.