Pilot and Feasibility Studies

Background Trials in occupational populations, such as surgeons, face feasibility challenges due to high workload, restricted availability, and clinical heterogeneity, which may compromise recruitment, adherence, and retention. Objective To prespecify the feasibility framework and progression criteria for an internal pilot phase embedded within a pragmatic randomized controlled trial (RCT) comparing Mechanical Diagnosis and Therapy with generalized exercise in surgeons with chronic spinal pain. Design Protocol for a prespecified internal pilot phase embedded within a pragmatic, two-arm, parallel-group RCT. Methods The internal pilot will include the first four months of recruitment and aims to randomize at least 12 participants. Feasibility will be assessed across predefined domains, i.e., recruitment, eligibility, consent, intervention uptake, adherence, retention, data completeness, and treatment fidelity. Each domain is operationally defined and linked to prespecified progression criteria to ensure interpretability and decision-making utility. Criteria will be interpreted collectively to guide trial continuation. A minimal qualitative process evaluation will be embedded. Ethics and dissemination The host trial has received ethical approval (N-20240046) and is registered at ClinicalTrials.gov (NCT07293130). The findings from the internal pilot will be reported in a separate feasibility manuscript.

BackgroundLifestyle interventions incorporating medically-tailored meal delivery may support rapid behavior change among pregnant individuals with gestational diabetes (GDM). PurposeTo examine the feasibility and acceptability of a multicomponent lifestyle intervention for pregnant individuals with GDM. Primary outcomes included recruitment, retention, intervention receipt, and acceptability. MethodsWe conducted a pilot randomized feasibility trial among pregnant individuals with GDM recruited from maternal fetal medicine clinics in the Hartford, Connecticut area. Participants were randomized to usual GDM care or the Meals4Moms intervention plus usual care. The intervention included medically-tailored meal delivery, personalized physical activity support, and multimodal education with digital tools. Participants completed a survey and three 24-hour dietary recalls at baseline and post-intervention. Meals4Moms participants also completed a semi-structured interview at follow-up. Intervention receipt was tracked by study staff. ResultsOf 30 individuals approached, we screened 80% (n=24), of whom 75% (n=18/24) were eligible; we randomized 8 participants. Seventy-five percent (n=6/8) completed at least one component of the follow-up assessment (100%, n=4/4 Meals4Moms, 50%, n=2/4 Usual Care). One participant spent [≥]80% of her total food budget (n=1/4, 25%), and no participants completed [≥]80% of prescribed exercise sessions (range: 0-50%). All (n=4) Meals4Moms participants reported they would be very likely to participate in the program if they had GDM again, and 100% (n=4) would be very likely to recommend the program to a friend with GDM. ConclusionsWhile the Meals4Moms intervention was highly acceptable to participants, procedural refinements are needed prior to conducting a full-scale efficacy trial.

Background: High blood pressure (BP) is an often treatable cause of cardiovascular disease. We developed an intervention, featuring a cardiovascular expert team and a toolbox, to support healthcare professionals (HCPs) in hypertension management and enhance patient self-management. Aim: This study evaluates the adoption and feasibility of this intervention. Design and Setting: A mixed-methods study in general practices in the Netherlands. Methods: HCPs could consult a cardiovascular expert team and use a self-management toolbox for their patients as preferred. We interviewed HCPs guided by the Consolidated Framework of Implementation Research (CFIR), and HCPs completed the Determinants of Implementation Behaviour Questionnaire (DIBQ). Using CFIR-ERIC matching tool, we matched implementation strategies to identified barriers. Adults with elevated BP, who were prescribed at least two blood pressure lowering medications were eligible to participate. Patient and disease characteristics were extracted from the electronical medical record. Results: Of 591 eligible patients at thirteen general practices, 176 participated. The cardiovascular expert team was well-received, with 33 unique consultations, although nurse practitioners (NPs) might need the expertise of the expert team more frequently than general practitioners (GP) (adoption). The toolbox was perceived as challenging to use (feasibility). We subsequently identified three key strategies to improve implementation. Mean systolic and diastolic BP were 158/87 mmHg at baseline and 148/85 mmHg after 12 months, although this change cannot be conclusively linked to the intervention. Conclusions: Structured implementation strategies may be helpful in hypertension management. The cardiovascular expert team was considered valuable, but might be better targeted to NPs rather than GPs.

BackgroundWalk n Watch (WnW) is a structured, progressive walking exercise intervention developed for Canadian inpatient stroke rehabilitation. Although its mechanisms align with UK guidance for intensive walking therapy, stroke rehabilitation in the UK is delivered predominantly in the community. This change in service context has implications for safety, feasibility, and fidelity, necessitating structured pre-implementation intervention adaptation to support delivery. MethodsA prospective adaptation process used ADAPT guidance. A multidisciplinary coalition and learning collaborative (UK clinicians, clinical- academics, people with lived experience, and Canadian WnW developers) participated in stakeholder co-production activities. Informed by ADAPT steps 1-2, co-production focused on rationale, core components, contextual mapping and planning adaptations. Discussions were analysed through rapid deductive mapping using Consolidated Framework for Implementation Research (CFIR) domains. Candidate fidelity-consistent adaptations were refined by the learning collaborative. Conceptual outputs of the process were synthesised. ResultsThree intervention core components were confirmed: 1) prioritised, high-volume, weight-bearing walking-related activities at moderate effort; 2) structured progression of steps based on performance on a walking test (e.g. Six-Minute Walk Test); 3) objective monitoring of steps and cardiovascular intensity. Several contextual determinants across CFIR domains were likely to influence UK community implementation. Fidelity-consistent modifications to the adaptable periphery were specified across four areas: 1) therapy & practice, 2) environment & safety, 3) monitoring & feedback, and 4) workflow & documentation. Adaptations included hybrid supervision, planned out-of-session practice, and monitoring using validated proxies. A WnW Adaptation Model was produced. ConclusionsThis paper provides a transparent pre-implementation adaptation of WnW for delivery within UK community stroke rehabilitation. Anchoring adaptations to intervention mechanisms and principles through co-production and implementation science frameworks, this work establishes a foundation for piloting and hybrid effectiveness-implementation evaluation. The WnW Adaptation Model offers support for future implementation efforts. Discussion positions adaptation as a pragmatic means for applying optimisation principles. PLAIN LANGUAGE TITLEAdapting the Walk n Watch walking exercise programme for home-based stroke rehabilitation in the UK: A structured step-by-step process PLAIN LANGUAGE SUMMARYO_ST_ABSBackgroundC_ST_ABSWalk n Watch (WnW) is a structured exercise programme that helps people improve their walking. It was originally developed for people recovering from stroke in hospital in Canada. While the approach fits well with United Kingdom (UK) recommendations for intensive therapy, stroke rehabilitation in the UK often takes place at home. Because of this difference, WnW needs careful adaptation for safe and effective delivery. MethodsPublished ADAPT guidance was used to adapt WnW. UK therapists, researchers, people with stroke, and Canadian WnW developers undertook adaptation activities. Together, they identified which parts of WnW were essential, explored differences between the Canadian and UK settings, and planned changes. Discussions were reviewed using an established framework to develop adaptations that kept the most important parts of WnW intact (fidelity-consistent adaptations). The adaptation process was summarised. ResultsThree essential intervention parts were confirmed: 1) prioritised, high-volume, weight-bearing walking-related activities at moderate effort; 2) structured progression of steps based on performance on a walking test; 3) objective monitoring of steps and cardiovascular intensity. Several factors were likely to influence delivery in the UK community. Changes focused on four areas: 1) therapy & practice, 2) environment & safety, 3) monitoring & feedback, and 4) workflow & documentation. They included using both in-person and online sessions, planning safe between session practice, and using non-digital monitoring. A WnW Adaptation Model was produced. ConclusionsThis paper clearly describes the steps taken to adapt WnW for delivery in UK community stroke rehabilitation. By working closely with stroke experts and using established research frameworks, the adapted programme keeps the most important parts of WnW while allowing it to fit into real-life. The WnW Adaptation Model offers support for further testing and may assist others looking to adapt WnW. Discussion offers perspective on how adaptation aligns with optimising interventions.

ObjectivesTo explore patients and physiotherapists perspectives on a snack-based physical activity (PA) approach and mobile health technologies (mHealth) for non-specific chronic low back pain (NSCLBP). Snack-based PA refers to short, frequent bouts of activity (2-5 minutes) integrated into daily routines. DesignQualitative study using Interpretative Phenomenological Analysis (IPA) of semi-structured online interviews. SettingCommunity-based recruitment in the United Kingdom. Interviews were conducted online via Microsoft Teams between May and November 2024. ParticipantsSixteen participants were purposively sampled: eight adults with NSCLBP (lasting [≥]3 months in the previous year) and eight physiotherapists with [≥]2 years experience managing people with NSCLBP. ResultsThree shared themes were identified across both groups: (1) understanding the needs and requirements of PA; (2) perceptions of snack-based activity; and (3) factors influencing mobile health application use. Five subthemes were identified within themes one and three, together with two additional subthemes reported only by patients, relating to data sharing and technical issues. Both groups valued the time-efficiency and practical integration of snack-based activity, while highlighting the need for personalisation, age-appropriate content, accessibility and affordability. ConclusionsPhysiotherapists and patients emphasised the potential value of the snack-based PA approach in terms of adherence. However, both groups agreed that future intervention development should prioritise personalisation, user-friendly design, and equitable digital access. STRENGTHS AND LIMITATIONS OF THIS STUDYO_LIThis study uses Interpretative Phenomenological Analysis (IPA) to provide in-depth, dual-perspective insights from both people with non-specific chronic low back pain (NSCLBP) and physiotherapists on a novel snack-based physical activity approach for chronic non-specific low back pain. C_LIO_LIReporting adhered to the Consolidated Criteria for Reporting Qualitative Research (COREQ) 32-item checklist to ensure methodological transparency. C_LIO_LIThe sample included variation in patient age, ethnicity and physiotherapist experience, which broadened the range of views captured. C_LIO_LIAll participants were UK-based, which may limit the transferability of findings to other healthcare systems and cultural contexts. C_LIO_LIThe small sample size, although consistent with IPA methodology, and the use of single online interviews, may not capture longitudinal perspectives on sustained engagement. C_LI

RationaleUp to 90% of strokes are preventable through the modification and control of lifestyle risk factors. Health and Wellness (HWC) coaching is an established psychological intervention that may address multiple risk factors, including high blood pressure to reduce the risk of stroke. AimsTo determine the effectiveness of HWC in the management of blood pressure and stroke-related modifiable risk factors in reducing the risk of stroke. MethodsThis Phase III, open-label, single-blinded, two-arm randomised controlled trial recruited adults with first-ever or recurrent minor stroke or transient ischaemic attack from hospitals in Auckland and Hamilton, New Zealand. Eligible participants were [≥]18 years, independent in activities of daily living, had at least two modifiable cardiovascular risk factors, elevated or treated systolic blood pressure, were English-speaking, and had no history of major stroke, myocardial infarction, significant cognitive or mood disorders, or terminal illness. Longitudinal outcomes will be analysed using linear mixed-effects models under an intention-to-treat framework, with time-to-event outcomes analysed using competing-risk methods and missing data handled using multiple imputation with pooling based on Rubins rules. Study outcomesThe primary outcome is difference in the mean change from baseline systolic blood pressure (SBP) to 6-months post-randomisation between control (Usual Care, UC) and HWC groups. The study (n=360) is powered 85% (two sided =0.05) to detect a mean difference in change of SBP 6 mm Hg (SD {+/-} 20 mm Hg) between HWC and UC groups at 6-months post-randomisation, accounting for a 20% attrition rate. A revised sample size calculation due to a lower attrition rate (9%) provided a required sample size of 320. Secondary outcomes include cardiovascular health score using the Lifes Simple 7; stroke awareness; quality of life; satisfaction with life: cognition; mood; medication adherence; adverse cardiovascular events; health and service costs and productivity status. DiscussionHWC has the potential to modify lifestyle risk factors for stroke. This trial will be the first to test the effectiveness of HWC to modify lifestyle risk factors for secondary stroke prevention. Ethical approvalThe trial was approved by the New Zealand Health and Disability Ethics Committee (#2022 EXP 124562022), and The Auckland University of Technology Ethics Committee (#22/206). Trial registrationACTRN12622000939796 (registered 01/07/2022)

Background HIV remains a major public health challenge in South Africa, with gaps in early diagnosis and linkage to care driving onward transmission. Adolescent girls and young women face barriers to timely care, including stigma, privacy concerns, and limited clinic access, while healthcare providers work in resource-constrained settings with high client volumes. We evaluated the Self-Care from Anywhere (SCFA) toolkit, an AI-enabled intervention comprising an AI Companion for AGYW and a provider-facing Clinical Portal to support HIV prevention, testing, and linkage to care. The AI Companion is designed to complement and extend human-delivered services, particularly in resource constrained settings, rather than replace in-person counselling. Methods We conducted an exploratory study to assess the usability, feasibility, and acceptability of the SCFA toolkit in Gauteng Province (November 2024-May 2025). AGYW engaged with the AI Companion, and a subset completed a simulated HIV self-testing activity with AI-delivered counselling. Pre and post-intervention surveys, including the System Usability Scale (SUS), were administered. Usability testing of the Clinical Portal involved healthcare providers using the toolkit without formal training to capture first impressions. A subset of AGYW and healthcare providers participated in separate focus group discussions or in-depth interviews. Quantitative data were analysed using descriptive statistics, and qualitative data were analysed thematically. Results A total of 97 AGYW were enrolled; 75.3% had completed high school and 91.8% were unemployed or full time students. Most participants (85.6%) self-reported HIV-negative status, and 63.9% reported sexual activity in the past 12 months. The AI Companion demonstrated high usability (mean SUS 87.7, SD 12.7) and was perceived as acceptable and useful, particularly for its personalisation and confidentiality features. Healthcare providers had a mean age of 34 years (SD 6.5), with about half serving as HIV testing and screening counsellors. Most providers rated the Clinical Portal ease of use, comprehension, and client support as positive to very positive, though 23% expressed concerns regarding workflow efficiency and their ability to manage additional client volume. Providers also highlighted the Clinical Portal value for case management. Conclusion AI-powered digital health tools, such as the SCFA toolkit, show potential to enhance user engagement and support care delivery, with high usability and acceptability demonstrated among AGYW and healthcare providers. Continued user-centred refinement is essential to ensure these tools remain responsive to the evolving needs and care contexts of diverse user groups.

BackgroundRoutinely collected prescribing and medicine-related data in Scotland are comprehensive and of high quality. However, they are generated across multiple healthcare settings and stored in complex source systems that are not optimised for longitudinal or outcomes-focused research. To maximise the research value of these data, there is a need for curated, analysis-ready resources that provide consistent representations of medicines exposure and enable linkage to clinical outcomes. The Medicines in Acute and Chronic care Scotland (MACCS) provides standardised, curated medicines data to support longitudinal analyses of medicine-related exposure across NHS healthcare systems. MethodsMACCS resource is a national individual-level medicines dataset for adults (18 years of age and older), derived from routinely collected prescribing and medicine-related data held by Public Health Scotland (PHS). It integrates data from the Hospital Electronic Prescribing and Medicines Administration (HEPMA), Prescribing Information System (PIS), and Homecare Medicines (HCM) datasets, which are linked at the individual level to eleven other national clinical records; including Scottish Morbidity Records (SMR00/01/02/04/06), laboratory data and mortality records; using the unique NHS Scotland person identifier. Data are curated, harmonised and pre-linked within the National Safe Haven and accessed by approved researchers through secure Trusted Research Environments. ResultsMACCS contains individual-level information on adults receiving NHS Scotland care, including patient demographics (such as age, sex and geographical indicators) and detailed records of medicines prescribing in community pharmacies as well as those administered in hospitals and through homecare services. Medicines-related data captures exposure dates and, where available, details on formulation, strength and dose. In addition, MACCS includes cancer registry data, renal registry data, laboratory test results, microbiology surveillance and mortality records. The earliest dates of data availability vary by source dataset. ConclusionMACCS provides a sustainable, longitudinal medicines research resource that simplifies access to complex national prescribing data and enables robust linkage to health outcomes. By supporting population-scale analyses across care settings, MACCS enhances the capacity for high-quality research to inform clinical practice, health policy, and medicines optimisation in Scotland. Key FeaturesO_LIThe Medicines in Acute and Chronic Care in Scotland (MACCS) data resource was established in 2025 to integrate medicine-related data with other electronic data from Scottish healthcare systems, creating a national, linked, routinely updated data resource at population level. C_LIO_LIMACCS provides pre-linked data from multiple routinely collected national datasets within NHS Scotland including, but not limited to, prescribing records, hospital episodes, laboratory results, and death records, within a single secure environment. C_LIO_LIMACCS includes patient demographics, data on medicines prescribing and administration/supply, key biochemistry and haematology test results (e.g., kidney and liver function tests), data on hospital admissions and surgical procedures, and date and cause of death. C_LIO_LIThe data resource provides longitudinal follow-up of the adult population ([≥]18 years of age) receiving medicines through NHS Scotland since 2010, covering approximately 4.6 million individuals, and supports pharmacoepidemiological studies, drug utilisation research, pharmacovigilance projects, as well as health services research. C_LIO_LIApproved researchers can apply through a streamlined process to access the linked MACCS data resource through established NHS Scotland governance processes, with data accessed within a Trusted Research Environment. C_LI

Background Chronic pain is common in adults aged 85 years and older (85+) and is associated with detrimental outcomes. Chronic pain guidelines advise first line management with non-pharmacological measures; paracetamol and non-steroidal anti-inflammatory drugs are the preferred analgesics. Challenges in accessing non-pharmacological therapies for adults aged 85+, and the presence of multimorbidity and polypharmacy, mean that opioid medication is often prescribed for chronic pain despite the potential for opioid-related adverse effects and guidance identifying long-term opioids for chronic pain as a potentially inappropriate prescription. Aim This study aims to explore patient, caregiver, and healthcare professional perspectives on the prescription of opioid medications for pain management for chronic pain in adults aged 85+ to support development of resources for optimising opioid prescribing. Design and Setting In this qualitative study, participants were recruited through primary care, in the community or in care home settings. Method 36 semi-structured interviews were conducted with care home residents and community dwellers aged 85+ (n=12), caregivers (informal and care home staff) (n=12), and healthcare professionals (n=12). Interviews were transcribed and analysed using reflexive thematic analysis. Results Four themes were developed: contextual complexity, satellite influences, balancing act, and pragmatic prescribing. Using opioids in adults aged 85+ is a balancing act to support patients best possible quality of life within their unique circumstances whilst using the pain management tools available. Conclusion Opioids continue to have an important role in pain management in adults aged 85+ largely due to paucity of alternatives and the drive to support quality of life.

Background: Lumbar spinal stenosis (LSS) can cause pain and severe walking limitation. Although surgery aims to improve walking, many patients do not achieve clinically meaningful gains. Rehabilitation can improve outcomes, yet existing programmes lack robust evidence and theoretical underpinning. This study aimed to (1) co-design a theory-informed rehabilitation programme to improve walking after LSS surgery, and (2) evaluate feasibility of conducting a future trial and acceptability of the intervention. Methods: A multi-methods study included intervention co-design followed by a single-arm feasibility study. Co-design used an adapted Experience-Based Co-Design approach with patients, carers, and healthcare professionals (n=39), integrating the Behaviour Change Wheel. This resulted in STructured Rehabilitation and InDividualised Exercise and Education (STRIDE), delivered over 12-week pre- and 12-weeks post-surgery, targeting knowledge, expectations, perceived control, physical capability, and fears. Adults aged [≥]50 years awaiting LSS surgery were recruited to a before-after feasibility study. Feasibility outcomes included recruitment and retention. Acceptability was assessed using the Theoretical Framework of Acceptability questionnaire (0-5 (high acceptability)) and focus groups. Clinical outcomes measured at baseline, post-prehabilitation, and post-rehabilitation included 6-minute walk distance (6MWD) and mean daily step count over 7 days. Results: Fifteen of 31 eligible participants were recruited (48%; mean age 70 years), with 80% retained to study end (2 decided against surgery, 1 unable to complete final assessment). Acceptability was high (median 5/5, IQR 0). Participants valued the personalised, supportive approach and reported improved motivation and preparation for surgery, though travel was burdensome. Small pre-operative and moderate-to-large post-operative improvements were observed in 6MWD (+49.9 m and +81.6 m) and daily step count (+868 and +1405 steps/day). Conclusions: This co-designed, physiotherapy-led, behaviour-change rehabilitation programme was acceptable to participants, with encouraging recruitment, retention, and signals of improved walking following LSS surgery. The findings support progression to a future trial.

BackgroundThe COVID-19 pandemic significantly accelerated the adoption of telemedicine, but it also exposed gaps in effective remote clinical assessment, particularly for medically vulnerable patients in rural areas. The ORCHARD intervention aimed to address this by providing patients with a Medical Self-Assessment Box to enable self-reporting of vital signs during remote consultations. MethodsA single-centre randomised mixed-methods feasibility trial recruited medically vulnerable patients from a rural general practice in Northeast Scotland. Participants in intervention group received a home medical equipment box for use during telemedicine consultations over six months. Patients and GPs were interviewed and transcripts were analysed using Framework Analysis. ResultsTwelve (15%) of 82 eligible invited patients enrolled. Six each were allocated to intervention and control group. 50%(n=3)patients in intervention group used equipment in 45%(5 of 11)teleconsultations and rated it helpful in all 5 uses (100%). The intervention group had 18% fewer primary care contacts than controls. All remote consultations were by telephone. Framework Analysis of patient interviews identified facilitators such as ease of use, improved triage access, reassurance, and barriers related to GP non-engagement and written instructions. GP interviews identified clinical value in patient-generated readings, alongside concerns regarding workload and patient over-monitoring. ConclusionsHalf of intervention participants used the medical-equipment box during remote consultations, all finding it useful, though frequency of use varied among particpants.A randomised controlled trial to evaluate the effectiveness of the Medical Self-Assessment Box for optimising remote consulting in medically vulnerable rural patients is feasible.Prior to a definitive trial refinements are recommended to patient labelling, GP engagement, and training materials.

Importance: Foot drop impairs mobility for many children globally, causing life-long health issues. Existing treatments are costly, custom-made, and require frequent clinical visits. A new, low-cost, off-the-shelf splint (OrthoPed) could improve access and user experience. Objective: To determine the feasibility of recruiting children (4-17 years) with moderate foot drop and collecting biomechanical, clinical, and patient-reported outcomes to compare OrthoPed with existing treatments. Design: Single-centre cross-sectional feasibility and pilot study informing a future randomised clinical trial. Participants: Twelve children (target=20; mean age=10.6 {+/-} 3.5 years; 2 females) with moderate foot drop and prescribed orthotic support were recruited via physiotherapy. Intervention: The new OrthoPed splint was compared against existing treatments: ankle foot orthoses (AFOs) and Lycra socks. Main outcome measures: Primary outcome: recruitment and retention rates. Secondary outcomes: biomechanical and clinical gait measures, alongside useability and performance questionnaires. Results: Recruitment reached 22% of eligible participants (an "amber" rating for future trials). Despite four dropouts due to treatment burden, all outcome measures were successfully collected. Preliminarily, OrthoPed supported more natural gait mechanics than AFOs and offered better usability and comfort than AFOs and Lycra socks, potentially enhancing adherence. Conclusions: Recruiting children for orthotic trials is feasible, though coordinating gait testing with routine clinical appointments could improve future recruitment. Importantly, low-cost orthotic devices may provide better usability, accessibility and adherence than existing prescribed options.

Background: Maternal mental health problems are common after prenatal diagnosis of congenital heart disease (CHD), with long-term implications for child and family wellbeing. HEARTPrep is a prenatal psychosocial intervention with three self-paced modules and corresponding telehealth sessions, delivered during pregnancy via mobile app to improve mental health and wellbeing for mothers expecting a baby with CHD. This proof-of-concept study evaluated the feasibility of HEARTPrep and examined maternal mental health and psychosocial functioning throughout participation. Methods: Participants were mothers receiving care for a fetal CHD diagnosis within one health system. Feasibility was assessed via rates of enrollment and completion. Mothers completed 4-item PROMIS questionnaires assessing anxiety, depression, and social isolation and reported self-efficacy and hope on a weekly basis throughout HEARTPrep. Results: Of 34 recruited mothers, 29 (85%) enrolled and two were subsequently not eligible (delivery prior to participation, change in fetal diagnosis), resulting in a final sample of 27 mothers. The majority (n = 22, 81%) completed all three telehealth sessions and Modules 1 (n = 22, 81%) and 2 (n = 19, 70%), with just over half (n = 14, 52%) completing Module 3 prior to delivery. Mean PROMIS depression T-scores decreased from 57.5 to 52.9, and 48% of mothers had a decrease in depression scores exceeding the meaningful change threshold (half standard deviation). The percentage of mothers reporting high self-efficacy increased from 19% to 48%. Conclusions: HEARTPrep is feasible and corresponds with reduced maternal depression and increased self-efficacy, supporting proof-of-concept. A randomized controlled trial is needed to determine whether HEARTPrep improves outcomes compared to a control group.

Objective: The shortage of general practitioners (GPs) in Australia has intensified interest in team-based care for hypertension, involving pharmacists and nurses. This study explored primary care provider experiences, barriers, and facilitators related to implementing team-based care in Australia. Design: Qualitative study using semi-structured interviews with primary care providers. Methods: We conducted 51 interviews with GPs (n=24), nurses (n=12), and pharmacists (n=15), purposively selected from diverse primary care settings. Analysis combined deductive coding, informed by the Theoretical Domains Framework and Consolidated Framework for Implementation Research, with inductive thematic analysis to identify emergent themes. Results: Interviews demonstrated a predominantly GP-centred care model, with nurse and pharmacist involvement largely confined to supporting roles, including blood pressure measurement, prescription refills, patient follow-up and counselling. Their contributions were constrained by barriers at both practice (e.g., limited GP support, fragmented communication across providers) and health system levels (e.g., limited financial incentives and restricted reimbursement pathways). Despite their critical role in care planning, nurses described being hamstrung by workload and limited direct funding for hypertension-related services. Pharmacists reported unreimbursed blood pressure checks and restricted funding for medication reviews that constrained the sustainability of their hypertension services. Role ambiguity and the absence of standardised protocols on task sharing further limited collaboration, with nurses and pharmacists describing concerns about overstepping professional boundaries. Attitudes towards team-based care ranged from active disregard (outright rejection) to conditional acceptance and occasional active uptake (strong endorsement). Conclusion: Despite clear willingness among nurses and pharmacists to alleviate GP burden, team-based care is rarely implemented in routine practice. Addressing system-level barriers (funding models that incentivise team-based care and standardised treatment protocols that clarify shared workflows), alongside provider-level barriers (stronger awareness and training that normalises task sharing), is critical to support genuine team-based hypertension care in Australia.

Background Interruptions in HIV care pose a major challenge to achieving HIV control goals in many countries, with 30% of clients who initiate antiretroviral therapy (ART) in South Africa experiencing an interruption of >28 days during their first six months on treatment. South Africa introduced revised guidelines in 2023 to improve outcomes during this early treatment period, but guideline compliance remains incomplete and gaps in the support provided to both clients and providers to optimize service delivery and health outcomes. Protocol BRIDGE (Behavioral Risk Identification and Decision Guidance for Engagement) is a mixed-methods evaluation of a package of light-touch, low-cost interventions aimed at improving the experiences of both clients and providers of care, increasing compliance with the 2023 guidelines, supporting clients to remain in care, and ultimately reducing the incidence of missed visits during the early treatment period. Components of the BRIDGE Retention Toolkit include an intervention navigator to help clients self-assess areas of vulnerability for disengagement from care and identify appropriate interventions; client roadmap to explain the treatment journey for the early treatment period; WhatsApp-based counseling tool for clients; guideline reference for providers; and tracing job aids. The tookit will be piloted at 6-8 public sector primary health facilities for a one-month period. The primary outcome will be the probability of returning less than 28 days late for the next scheduled clinic visit, assessed using electronic medical record data for the pilot and comparison sites. Pilot outcomes will be compared to both their own probabilities prior to the pilot and to probabilities from comparable non-pilot facilities. Implementation outcomes to be assessed using qualitative interview data from both clients and providers will include reach, implementation fidelity, adoption (uptake), costs, feasibility, appropriateness, and acceptability. Discussion The evaluation will assess the implementation and preliminary effectiveness of a set of interventions designed to improve client outcomes during the early HIV treatment period. If some or all of the BRIDGE tools are found to be helpful and/or are associated with a reduction in missed clinic visits, they will comprise a readily scalable and affordable intervention to help address a major barrier in large-scale HIV treatment programs.

Introduction: Our aim was to examine the implementation of an online community-based exercise (CBE) intervention with adults living with HIV. Methods: We conducted a 12-month community-engaged intervention study with adults living with HIV in partnership with the Toronto YMCA, Canada. We conducted a two phased intervention study involving Phase 1) Intervention: participants were asked to exercise three times/week, supervised every two weeks with online personal coaching, and attend monthly online educational sessions (6-months), and Phase 2) Follow-Up: participants were asked to continue exercising thrice weekly, independently (6-months). We assessed engagement in physical activity (PA) weekly, and body composition, strength, physical function, and flexibility outcomes every two months (bimonthly) across both phases (12-months). We used segmented regression to assess the change in outcomes within and between phases to assess adoption, effect and maintenance of the intervention. Results: Of the 32 participants who initiated, 22 (69%) completed the intervention; and 18 (56%) completed the follow-up. The majority identified as men (69%), median age was 53 years (25th, 75th percentiles: 43, 60), with a median of 3 (1,7) concurrent health conditions. Median number of coaching sessions attended was 10/13 (77%). Participant engagement in [≥]30min of moderate or vigorous physical activity in the past week increased from 3.24 days at baseline (95%CI:2.69, 3.79) to 3.36 days (95%CI:2.83,3.89) at the end of intervention to 3.35 days (95%CI:2.81,3.89) at end of follow-up [overall mean increase of 0.11 days (95%CI: 0.02,0.20)]. During the intervention, there were significant mean decreases for weight (-1.31kg), body mass index (BMI) (-0.40kg/m2), and waist circumference (-2.92cm); and mean increases for push-ups (+7.11 in a minute), plank time (+38.13 sec), sit-to-stand (+2.86 times in 30 sec), and sit-and-reach (+3.47 cm). There were no changes in muscle mass, body fat percent and fat free mass. During the follow-up phase, there were additional significant mean decreases in body weight (-1.52 kg), BMI (-0.50 kg/m2) and sit-to-stand (+1.52 times in 30 sec). Conclusions: Participants demonstrated increases in physical activity and improvements in strength, weight, body composition, physical function, and flexibility with the online CBE intervention, some of which were sustained at the end of the study. Future research should incorporate strategies to enhance engagement in physical activity among adults with HIV.

BackgroundInteractive dashboards can support safe prescribing but effectiveness depends on user engagement. The research team developed a prescribing safety dashboard, deployed in 27 Irish general practices. Trend graphs tracked prescribing changes (2019-2025) by practices across key metrics. This study explored how GPs engaged with the dashboard and their perceptions of using routine data for prescribing feedback. MethodsPrescribers from participating practices were invited to online interviews (May-August 2025). A think-aloud exercise involved participants verbalising their thoughts while navigating the dashboards, followed by a semi-structured interview exploring views on safe prescribing, feedback and data access. Interviews were recorded, auto-transcribed and manually reviewed for accuracy. Think-aloud data were analysed deductively using a sense-making framework, interviews analysed inductively, and findings triangulated to refine themes. ResultsNine general practitioners (GPs) from eight practices participated. Themes were organised into four categories: (1) Perceptions of open data, (2) Perceptions of feedback, (3) Dashboard engagement, and (4) High-quality prescribing. Most were in favour of open data and transparency but some feared misuse. GPs valued feedback but reported workload as a barrier. Engagement with the dashboard was mainly interpretative, focused on data meaning in the context of their practice. GPs showed a strong emotional dimension to engagement and also described intended actions in response to what they saw. Finally, high-quality prescribing was mainly viewed as avoiding harm. ConclusionsGPs valued and engaged with dashboard feedback but workload competed with time for reflection and action-highlighting the need for practical, streamlined tools and nudges to support engagement. Key messagesO_LIAudit and feedback, such as that delivered through interactive dashboards has a small but significant effect on professional behaviours such as prescribing, but user engagement influences effectiveness. C_LIO_LIIrish GPs engaged with a prescribing safety and quality dashboard in a reflective and contextual way and garnered rich insights on their prescribing. C_LIO_LIGPs valued feedback and showed a strong emotional attachment to their performance, but felt workload competed with time for reflection and action. C_LIO_LIWith advances in data infrastructure, it is possible to provide interactive prescribing feedback in real time. However, the way feedback is designed and delivered plays a crucial role in supporting engagement. Dashboards and related behavioural interventions should be co-designed with prescribers to maximise engagement. C_LI

Background Occupational exoskeletons are used to reduce physical workload and prevent work-related musculoskeletal disorders in physically demanding jobs. Although laboratory studies demonstrate reduced muscle load during simulated manual work tasks, evidence from long-term, real-world implementations remains very limited. The RELAX project aims to investigate the long-term effects of a passive back-support exoskeleton (BSE) during manual order-picking work in a Danish warehouse, focusing on health and socio-economic outcomes. Methods This 18-month controlled in-field intervention study compares outcomes at two warehouse departments: one where workers use a passive BSE and a control group where workers perform work tasks as usual. Approximately 90 full-time workers will be followed during the intervention period with questionnaires, interviews and company-registered performance indicators. Primary outcomes include perceived work intensity and musculoskeletal discomfort, while secondary outcomes include sickness absence, employee turnover, productivity and cost effectiveness. Furthermore, a process evaluation will be conducted based on questionnaires, focus-group interviews, and reported exoskeleton use. Quantitative effects will be analysed using difference-in-difference analysis with generalized linear mixed models to account for repeated measures over time. Employee turnover will be analysed using time-to-event analysis, and qualitative focus-group interviews will be analysed using reflexive thematic analysis to explore implementation processes and contextual factors. Cost-effectiveness and return on investment will be assessed by comparing the investment with potential savings in costs and resource use. Discussion By combining longitudinal quantitative outcomes with qualitative process evaluation, the study seeks to provide ecologically valid evidence on the effectiveness, feasibility and sustainability of occupational exoskeleton implementation. This approach will help clarify whether long-term exoskeleton use improves worker health without compromising productivity and may inform future workplace guidelines and large-scale adoption strategies.

Background: Two-thirds of Dutch cardiovascular risk management (CVRM) for patients at risk of cardiovascular disease is delivered in primary care practices. While individual risk scores are increasingly used during consultation, a population-level structure for risk-based patient outreach is not currently available. We therefore developed the PROSPERA programme, a multilevel intervention comprising population-level risk stratification and individual-level support tools. Aim: To assess anticipated and experienced barriers and facilitators among healthcare professionals (HCPs) to inform implementation in primary care. Methods: We conducted four focus groups and six interviews with nine primary care HCPs to explore anticipated and experienced barriers and facilitators. Inductive codes were thematically analysed and assigned to corresponding domains of the Theoretical Domains Framework (TDF) and the related Capability, Opportunity, Motivation model of Behaviour. Results: Barriers and facilitators were identified in 11 TDF domains. Population-level barriers included altered professional roles and limitations in technological infrastructure. Individual-level barriers were limited skills in interpreting risk calculations and difficulty integrating tools into clinical routine. Facilitators were related to beliefs on the importance of providing proactive care (population level), the use of U-Prevent for risk communication (individual level) and positive patient responses to the Lifestylecheck questionnaire (individual level). Conclusion: Addressing barriers and facilitators identified at both the population and individual levels can support implementation of the PROSPERA programme. Opportunities exist in education and training of HCPs in risk communication, as well as support in restructuring the physical and digital environment.

BackgroundPrimary care practitioners are well-positioned to support people of reproductive age in preparing for pregnancy and parenthood. Such "preconception care" is ideally delivered opportunistically during routine consultations, although limited time presents a barrier. AimTo achieve consensus on priority topics for opportunistic preconception care in general practice. Design and settingA three-step consensus study involving UK-based primary care practitioners and people of reproductive age. MethodThe consensus process involved: 1) identifying potential topics through literature and guideline reviews, workshops with people of reproductive age (n=15), and interviews with primary care practitioners who work in general practice (n=14); 2) prioritising topics using a Delphi survey (n=85 participants completing round one, n=63 completing all three rounds); and 3) agreeing on priority topics during an online consensus workshop (n=21 participants). Participants were recruited through a Public Advisory Group, charities, and professional organisations. ResultsReviews and workshops/interviews with people of reproductive age and practitioners identified 37 potential topics. The Delphi survey and consensus workshop identified 16 priority topics. These were combined into four overarching topic areas for discussion during relevant consultations: O_LIPatient knowledge of preconception health and pregnancy C_LIO_LIIdeas, concerns and expectations (e.g. pregnancy intention, prior pregnancy experiences) C_LIO_LIHealth conditions (e.g. medication use, mental/physical health, immunisation) C_LIO_LIHealth behaviours (e.g. folic acid supplement use, smoking, alcohol consumption). C_LI ConclusionThe agreed priority topic areas offer a structured foundation for delivering patient-centred, opportunistic preconception care in primary care. The findings support future co-development of practical tools and resources to enable routine implementation. How this fits inPreconception care improves pregnancy outcomes, but in UK general practice it is inconsistently delivered, partly due to limited time and guidance that offers little prioritisation for opportunistic consultations. This study identifies four overarching topic areas for preconception care, based on consensus among people of reproductive age and primary care practitioners. The resulting priority list offers clinicians a practical, flexible way to initiate patient-centred preconception care discussions within routine consultations.