Pilot and Feasibility Studies

Background.Only one in five people with hypertension have their blood pressure (BP) controlled (<140/90 mmHg). Patient education improves BP control, yet there is limited guidance to adapt to individuals evolving needs across the hypertension management journey. This study aimed to identify key behavioural barriers and enablers to patient education throughout the hypertension management journey, which were synthesised into patient personas to support translation and practical application. Methods.Qualitative interviews with adults ([&ge;]18) who self-monitor BP, and primary care providers involved in hypertension care. Interviews explored the experience of accessing and delivering patient education for BP measurement and management. Using framework analysis, patient personas were developed in three steps: 1) thematic analysis of patient interviews to identify key barriers and enablers to hypertension patient education and mapping the identified barriers and enablers to key time-points in the hypertension journey (diagnosis, treatment initiation, long-term management), 2) clustering behavioural factors via the capability, opportunity, motivation-behaviour model, which were then synthesised as preliminary patient personas and refined using practitioner interviews and, 3) validation by consumer consultation feedback sessions. Results.Patients (n=27) and practitioners (n=12; n=4 general practitioners, n=4 nurses, and n=4 pharmacists) were aged 18-60 years (52% of patients and 100% of practitioners fell within this age range). Several behavioural barriers to patient education for hypertension management included patient overwhelm, inconsistent guidance provided by health professionals, and perceived patient disengagement, while a strong desire to self-manage was a consistent enabler. Six clusters of behavioural barriers and enablers were synthesised as patient personas, capturing the factors that shape education needs and experiences across the hypertension management journey. Conclusions.The patient personas highlight opportunities for tailored patient education strategies through the development of patient personas. Practice implications.The patient personas provide a practical tool for designing person-centred interventions in primary care.

AimTo outline the opportunities and barriers when using hairdressing salons as a novel site for enhancing cardiovascular risk factor assessment and management in women. MethodsA process evaluation nested within a cluster-randomised trial, Hairdressers for Health. The trial evaluated a nudge intervention advising women [&ge;]45years attending hairdressing salons to undertake a Heart Health Check with their General Practitioner. The UK Medical Research Council process evaluation framework was used to guide the design, data collection and analysis. Nineteen interviews were conducted with nine hairdressers, nine study participants and a project officer. Thematic analysis assessed recruitment, reach, acceptability, and adoption. Characteristics of the salons and participants were analysed using descriptive statistics. ResultsRecruitment of the planned 88 metropolitan and 28 regional salons for the trial was challenging, requiring resource-intensive face-to-face visits. The nudge intervention was well accepted by participants, and salons were perceived to be an appropriate setting to effectively reach women. Adoption of the study by salons was limited with only 54 of the 116 salons recruiting participants (total recruited 239, range 1-22 participants per salon). Barriers to participant recruitment included technological constraints while using a decentralised online recruitment and data collection platform, client preferences and privacy concerns. Established hairdresser-client relationships in smaller salons facilitated greater client participation and was perceived as a good mechanism for health promotion. ConclusionsCardiovascular health prevention messaging for women in salons was acceptable to hairdressers and clients. Designing the study to make better use of hairdresser-client personal relationships may have improved project implementation. Trial RegistrationACTRN12621001740886

BackgroundThe self-management of type 2 diabetes (T2D) typically requires enacting various lifestyle changes, which can challenge people living with T2D. Clinical encounters between people with T2D and their clinicians, however, are often focused on metabolic management, leaving less time available for other self-management topics. The QBSAFE cards help patients articulate aspects of their experience with diabetes and prioritize issues for discussion. MethodsThis report details secondary outcomes of a randomized controlled trial; primary outcomes are reported elsewhere. All data was collected at Fair Haven Community Health Care, a federally qualified primary care clinic. 11 clinicians were randomly assigned to provide either usual care or usual care with QBSAFE cards to 155 of their patients with type 2 diabetes and hemoglobin A1c >8%. All patient encounters were video recorded for analysis. Patients and clinicians were not blinded to arm allocation but were kept unaware of the specific aims of the trial. Encounter video reviewers were blinded to arm allocation, but not to specific aims of the trial. The outcomes of interest for this report were the extent to which the QBSAFE cards were used as intended, their effect on the topics of discussion, and whether they enabled clinicians to notice and respond to each patients situation; comparisons between arms were conducted by a linear mixed model with fixed effect of arm and cluster effect of clinician, analyzed in both intent-to-treat and per-protocol populations. Findings12 patients were excluded post-randomization (A1c <8%). Of 143 eligible patients, 137 encounters (65 in the usual care arm, 72 in QBSAFE) yielded evaluable videos. QBSAFE was used as intended in 61 (85%) QBSAFE arm encounters. Conversations about burden of treatment related to non-pharmacological interventions (17 vs 33, p= 0{middle dot}04) and taking medications (11 vs 33, p= 0{middle dot}0008) and about the patients challenging environment (2 vs 10, p= 0{middle dot}04) were more prevalent in the QBSAFE group. There was no difference in the rate of conversations about metabolic management or of new care plans as a result of conversations between groups. InterpretationWhile there was a difference in the types of conversations observed between the two study arms, this difference was small and only apparent in a few domains. Future work could aim to modify the QBSAFE cards to more effectively stimulate patient-centered discussions and to further prepare clinicians to respond to a variety of issues raised during the clinical visit. FundingThis work was supported by funding from the National Institute of Diabetes and Digestive and Kidney Diseases (R01DK129616).

Background and objectivesType 1 diabetes (T1D) is a largely self-managed condition that requires ongoing daily tasks and decisions. Many people living with T1D in Canada manage it alone, which can feel very isolating and negatively affect physical and mental health. Connecting with other people in similar situations may help to reduce the potential burden associated with managing this health condition. We aim to co-develop and evaluate a virtual peer support program called CommuniT1D, led by people with T1D, to improve the overall wellbeing of people across Canada whose lives are affected by T1D. Methods and analysisUsing a community-based participatory design and action research approach and a realist evaluation framework, we will first co-develop CommuniT1D by working together as a group of people with T1D, researchers, and clinicians. Over two thirds of steering committee members live with T1D (their own or their childs.) This collective lived expertise is complemented by experts in mental health, social support, health services research, and other relevant fields. Once the program is ready to welcome members, we will work with our partner organizations, networks, and use tailored ads to recruit CommuniT1D peer leaders and members. We will then form virtual peer support groups of people with shared lived experience. Within the program, we will hold monthly small group meetings led by peer leaders via an online platform. We will also hold monthly large webinars open to all CommuniT1D members and other interested people. To evaluate CommuniT1D, we will conduct surveys at baseline and every 6 months, collecting data about diabetes distress, life challenges, quality of life, wellbeing, management indicators, and access and use of management tools and services. We will analyze quantitative data using repeated measures analysis of variance. We will also conduct individual interviews with CommuniT1D members and peer leaders at two time points. We will analyze interview data thematically, and create a logic model by triangulating results from qualitative and quantitative analyses, applying a realist evaluation lens. DiscussionPeer support may help people with T1D feel less alone and better supported. This protocol outlines the design of a virtual peer support program called CommuniT1D to improve the wellbeing of people whose lives are affected by T1D in Canada. We hope that this program will help better equip people with T1D to cope with T1D-related stressors, thus improving the lives of people with T1D in Canada.

QuestionDo advanced practice physiotherapists succeed in conducting shared decision-making (SDM)? DesignA prospective cross-sectional observational study of patients with musculoskeletal pain and their perceptions of SDM measured using the CollaboRATE instrument. Written feedback was collected after consultation to gain understanding of patients experiences of their consultations. ParticipantsChronic pain patients (n = 5123) diagnosed with either upper limb (n = 1230, 24%), lower limb ((n = 3044, 59.4%), or foot/ankle pain (n = 849, 16.6%) consulting an advanced practice physiotherapist across two hospitals in the UK between January 2023 and December 2024. ResultsMean total CollaboRATE scores across all items were 11.9 ({+/-}0.53). Overall, 4906 (95.8%) of participants gave the maximum CollaboRATE score of 12. No significant differences were observed between sites (p < .001). A regression model including site and pain category was statistically significant but explained minimal variance (R{superscript 2} = 0.004), suggesting other factors contribute more substantially to SDM perceptions. From 949 patient responses, our qualitative analysis revealed a generally positive SDM experience with advanced practice physiotherapists. Feedback clustered around five key themes: 1) feeling valued and involved, 2) communication, expertise, and clarity, 3) compassionate and professional care, 4) efficient organisation, and 5) negative experiences. ConclusionAdvanced practice physiotherapists were largely successful in facilitating SDM, with patients reporting positive experiences across both clinical sites. While quantitative findings showed minimal influence of site or pain category, qualitative insights highlighted the importance of clinician communication, empathy, and involvement of patients in care planning as key drivers of SDM perceptions.

Background and AimsNon-adherence to antihypertensive therapy is a major contributor to poor blood pressure (BP) control, increased cardiovascular risk, and higher healthcare costs. Behavioral economics suggests that financial incentives and mobile-based interventions may support behavior change, yet evidence for such strategies in central Europe is limited. ObjectiveThe BEHAVE-HTN study evaluates whether a multi-faceted medication adherence mobile application (mApp) with behavioral economic principles--including reminders, gamification, and financial incentives--improves medication adherence in patients with hypertension compared to standard of care. MethodsThis multi-center, randomized, open-label trial will include 180 outpatients with hypertension taking four or more pills daily. Participants will be randomized into three groups (n = 60 per group): (A) mApp with contingent financial incentives, (B) mApp without incentives, and (C) standard of care. All participants will receive a Medication Event Monitoring System (MEMS) dispenser to objectively track adherence. The primary endpoint is the difference in mean MEMS adherence between group A and the control group at 90 days. A co-primary endpoint compares MEMS adherence in the final vs. initial month of the intervention. Secondary outcomes include changes in BP, app-reported adherence, and patient-reported feedback on the mApp. ResultsCurrently, participant inclusion has been nearly completed. We are undergoing data clearing and are planning data analysis. These steps are planned for autumn 2025. ConclusionThis study will provide evidence on whether a multi-faceted medication adherence mobile App -- with or without financial incentives--can improve medication adherence in hypertensive patients. The findings may support the implementation of mobile health strategies in routine hypertension care. Trial RegistrationSNCTP000004345; ClinicalTrials.gov Identifier: NCT04708756

PurposeTo evaluate the feasibility, impacts, and perspectives of a family-led robotic walking intervention. Materials & MethodsThis single-arm interventional study recruited participants aged [&ge;]4 years with pediatric-onset neuromotor disorders. Participants were lent a robotic walker and recommended to use at least 150min/week for 12-weeks. Robotic walking use, acceptability, practicality and adverse events were tracked. Family goals were measured before and after training period using Canadian Occupational Performance Measure (COPM). Quality of life was examined using EQ-5D-Y, Carer-QoL, and CP-CHILD. Quantitative data were analyzed using descriptive statistics (median (25th-75th percentile)) and Wilcoxon signed-rank tests. Qualitative interviews captured family perspectives and were analyzed using thematic analysis. Results15 participants aged 4-23 completed this study. Participants trained 5 (3.5-6) times for 150(82-181) minutes and took 7,544(4,640 - 9,575) steps each week. Adverse events occurred in <1% (16 minor, 1 moderate) of robotic walking sessions. Performance (3.5 (1.9-4.5), p=<0.001) and satisfaction (3.3(3.0-5.0), p=<0.001) of goals increased. Parents described positive changes in social experiences and family interactions and difficulties with the logistics of robotic walking. ConclusionsThis family-led robotic walking intervention resulted in improvements in individual goals, though families did struggle with some logistics of robotic walking, such as; transport and difficulties with the device.

BackgroundPsychedelics exert widespread effects on brain activity, but their impact on motor function is unclear. This is clinically relevant given the emerging interest in psychedelic-assisted physical therapy for disorders of motor function. This studys primary objectives examined the feasibility and safety of administering movement tasks following low-to-moderate doses of psilocybin in healthy volunteers. MethodsHealthy participants were randomly assigned three psilocybin doses consisting of either (1) 5mg, 10mg, and 15mg, or (2) 10mg, 15mg, and 20mg, with at least one week between doses. Movement tasks were administered during the acute drug effects. Participants, physiotherapists, and statisticians were blinded to the dosing order. Feasibility was assessed by evaluating completion of the de Morton Mobility Index and Functional Movement Exploration (measures of gross motor function). Safety outcomes included vital signs and adverse events. Additional exploratory motor outcomes included the Action Research Arm Test (assessing dexterity), Box and Block Test (Original and Modified versions) (combining dexterity with motor speed), Digit Symbol Substitution Test (combining motor speed with intellectual functions), and Reaction Time Ruler Drop Test (assessing reaction time). The 5-Dimensional Altered States of Consciousness and Ego-Dissolution Inventory assessed changes in states of consciousness. Blinding efficacy was assessed by asking participants and physiotherapists to guess the doses administered. ResultsThirteen participants were randomised: seven to 5mg, 10mg, and 15mg; six to 10mg, 15mg, and 20mg. One participant was unable to complete several movement tasks at 20mg. Nausea (n=8, 62%) and headache (n=7, 54%) were the most common adverse events. No serious adverse events or adverse events related to movement task administration occurred. Median values [interquartile ranges] remained near-perfect across doses for the de Morton Mobility Index (92.5-100.0 [85.0-100.0]), Functional Movement Exploration (100.0 [96.0-100.0]), and Action Research Arm Test (56.0-57.0 [52.0-57.0]). Baseline Box and Block Test (Original) median scores (65.0 [60.0-67.0]) improved to 79.0 [70.0-83.0] at 5mg and 4.5 hours post-dose (5mg-4.5H), and worsened to 57.5 [51.0-64.0] at 20mg-1.5H. Baseline Box and Block Test (Modified) median scores (48.0 [47.0-53.0]) worsened to 43.0 [35.0-45.0] at 20mg-1.5H. Baseline Digit Symbol Substitution Test median scores (73.0 [66.0-77.0]) improved to 87.0 [81.0-90.0] at 10mg-4.5H, and worsened to 62.0 [54.0-86.0] at 20mg-1.5H. Reaction Time Ruler Drop Test scores lacked consistent dose-related changes across participants. Changes in states of consciousness were greatest at 20mg. Participants and physiotherapists correctly guessed the administered dose 53% and 50% of the time, respectively. ConclusionsMovement tasks were feasible during psilocybin dosing up to 15mg. Impairments emerged at 20mg in tasks that combined motor and additional cognitive functions. These findings support the feasibility of performing complex movement tasks during psilocybin dosing and will inform the conduct of trials utilising psilocybin-assisted physical rehabilitation in neuropsychiatric disorders. Trial RegistrationAustralian New Zealand Clinical Trials Registry: ACTRN12621000560897 Date registered: 12 May 2021 URL: https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=381526&isReview=true Key FindingsO_LIThere is growing interest for psychedelic-assisted physical therapy in neuropsychiatric disorders of motor dysfunction, however, the impact of psychedelics on motor function remains unclear. C_LIO_LIThis study investigated the feasibility, safety, and impact on motor function of administering movement tasks following low-to-moderate doses of psilocybin in healthy volunteers. C_LIO_LIThese findings support the feasibility of performing complex movement tasks during psilocybin dosing up to 15mg and will inform the conduct of trials utilising psilocybin-assisted physical therapy in neuropsychiatric disorders. C_LI

BackgroundType 2 diabetes (T2DM) and cognitive impairment are common long-term chronic conditions affecting older people in hospital. Cognitive impairment can complicate glucose monitoring and lead to diabetes-related emergencies in T2DM. Traditionally, point of care test (POCT) measurements of capillary blood glucose are conducted in-hospital for T2DM while continuous glucose monitoring (CGM) is not widely used. AimTo understand the feasibility, acceptability and tolerability of using CGM in older in-patients with T2DM and cognitive impairment. MethodsThirty-two older people (mean age = 78.7 {+/-}6.7 years) with comorbid T2DM and cognitive impairment (AMT [&le;]8/10 and Mini-ACE [&le;]22/30) were recruited within a tertiary care hospital in the UK. All participants were naive to CGM and were asked to wear blinded Dexcom G7 sensors for up to 10 days. Participants were asked about feasibility, acceptability and tolerability questions at the point of sensor removal. ResultsTwenty-nine participants (96%) reported no pain during CGM fitting. All participants (100%) agreed that they did not notice wearing the sensor, and it did not affect their day-to-day hospital activities. All participants (100%) found it very easy or easy to have the sensor fitted and wearing it for 10 days, with 27 participants (90%) finding CGM convenient. Seventeen participants (57%) reported favourable perceptions of the subcutaneous sensor sensation. ConclusionCGM use in older in-patients with T2DM and cognitive impairment is highly feasible and acceptable for patients. Future studies and trials are now needed to evaluate the clinical use of CGM for glucose monitoring in hospitalised or community-dwelling older individuals with T2DM and cognitive impairment.

BackgroundApproximately 1 in 5 Canadians experience a mental health illness in any given year. While most individuals can be successfully treated within a primary care setting, a subset of individuals present with a severity and complexity requiring specialist care. Unfortunately, a shortage of psychiatrists (especially in rural regions) can result in wait times of months to years. MethodsWe designed the Alberta Network for Community Health Outreach and Rural Mental Health. ANCHOR-MH is a 12-week program that includes a unique educational intervention, collaborative case conferencing, and a community of practice between family medicine (FM) physicians and psychiatrists. We enrolled two pilot cohorts of n=20 FM physicians each and measured participants confidence and comfort in diagnosing, managing, and treating psychiatric conditions. We also conducted qualitative analyses of their experience. ResultsData from participants that completed both the pre- and post-program survey (n=34) showed increased confidence in screening for, diagnosing, and managing psychiatric issues, as well as increased comfort discussing mental health concerns with patients and families and reduced stigma towards certain psychiatric conditions. Qualitative thematic analysis (n=39) reflected this increased confidence, revealed an increased sense of connectedness to the mental healthcare landscape, and highlighted specific examples of practice changes. Participants broadly agreed that the program improved their ability to provide mental healthcare and would improve psychiatric outcomes within their practice. InterpretationANCHOR-MH improved FM physicians confidence and ability to deliver mental healthcare in their primary care settings. Increasing the reach of this program may improve mental healthcare in underserved communities.

BackgroundCommunication issues across the primary-secondary care interface are considered one of the most important challenges in improving patient safety in primary care in the UK. Teleconferencing offers a potential means of improving communication during referrals but is largely unevaluated. AimTo explore teleconferencing as an alternative to written Advice and Guidance (A&G) referrals for neurology cases, by assessing its impact on GP-specialist communication and relationships, and exploring implications for patient care. Design and SettingA qualitative case study of a primary care network (PCN) and a secondary care centre in East Anglia. Methods18 clinicians and 10 other stakeholders were interviewed. Observations of teleconferences and a focus group with five PCN staff provided additional data. Data collection and analysis were guided by the Consolidated Framework for Implementation Research and Reflexive Thematic Analysis. ResultsAdvantages of teleconferencing identified by participants included greater clinician satisfaction, mutual educational value, streamlined patient journeys and continuity of care. Teleconferences were also seen to build GP-specialist relationships and reduce unnecessary outpatient referrals. Perceived issues included time constraints, clinical governance and funding sustainability; teleconferences were not seen as appropriate for all referrals. Overall, participants welcomed the teleconference approach but stressed the need to robustly assess its cost-effectiveness and replicability in other settings. ConclusionTeleconferencing is a potentially promising alternative to written A&G referrals and was perceived by participants to help build GP-specialist relationships. However, further studies are needed to assess clinical effectiveness and costs, and to guide future development and implementation. How this fits inO_ST_ABSWhat is known?C_ST_ABSReferral interventions involving direct GP-specialist dialogue can enhance referral quality, reduce outpatient referrals and improve GP-specialist relationships, with some demonstrating improved clinical outcomes. However, they often face sustainability challenges, and their cost-effectiveness and mechanisms of impact require further assessment. What does this study add?This qualitative study identifies key mechanisms through which virtual GP-specialist dialogue may lead to downstream benefits: enabling shared decision-making and delivering consultant-level care closer to home; empowering GPs to manage complex cases; and reducing overall workload across primary and secondary care systems. The programme theory developed can be used to guide future intervention design, implementation and evaluation.

BackgroundIndividuals with severe mobility impairments (SMI) often experience significant psychological distress and chronic pain. Virtual walking (VW) presents an innovative rehabilitation approach to improve mood and alleviate pain. This study aimed to develop a home-based VW system with integrated mood and symptom tracking and to report on its feasibility and usability in a user study with individuals with SMI. MethodsA multidisciplinary, iterative frame-work guided the systems development. Following initial contextual research and design iterations, a user study was conducted with 11 participants with SMI. A repeated measures pre-post design was employed. Feasibility and usability were primarily assessed through post-study qualitative interviews, analyzed via content analysis. Changes in mood and symptoms were measured immediately before and after each session. Momentary mood was captured using an in-virtual reality (in-VR) two-dimensional (2D) affect grid, while embedded single-item state ratings were used to track anxiety, depressed mood, and pain. Daily mood changes and symptom trajectories were analyzed using logistic regression and generalized estimating equations (GEE), respectively. ResultsContextual research guided the system design towards enhancing accessibility, ergonomics, and therapeutic engagement. The final VW system featured three core modules: locomotion, multi-sensory feedback, and mood/symptom tracking. Qualitative analysis of the user study revealed high acceptance for the VW system, alongside challenges related to content variety and hardware ergonomics. Each intervention session was significantly associated with an immediate positive mood shift (odds ratio (OR) = 1.83), as measured by the affect grid. Furthermore, GEE models revealed a significant reduction in self-reported depression and anxiety symptoms over the intervention period (all P < 0.01). ConclusionsThis study confirms the feasibility and acceptability of the novel VW system for home-based use by individuals with SMI. The preliminary evidence suggests the system has high potential as a tool for improving mood and alleviating psychological distress. Future large-scale randomized controlled trials are warranted to establish its clinical efficacy. Trial registration numberNCT07073144-07/17/2025.

BackgroundHypertension is a major modifiable risk factor for cardiovascular disease, yet blood pressure (BP) control remain suboptimal, particularly in socially disadvantaged communities. Guidelines recommend initiating single-pill combination (SPC) therapy to improve adherence and BP control, but uptake in primary care is limited. ObjectivesTo evaluate the SOLO care improvement project, promoting SPC initiation among general practitioners (GPs) in Amsterdam Zuidoost, a disadvantaged, multi-ethnic community in The Netherlands with a high hypertension burden. MethodsIn a cluster quasi-randomized cluster design, adult hypertensive patients from nine general practices within one health facility were allocated to intervention (IC; n=5) or usual care (UC; n=4). Intervention practices received case-specific guidance on SPC therapy. Outcomes were SPC uptake, changes in systolic and diastolic BP (SBP and DBP), target BP achievement and cardiovascular events. Analyses used intention-to-treat adjusted regression and Cox models, with additional as-treated analysis among SPC users. ResultsAmong 438 patients (mean age 64.5{+/-}12.2 years; median follow-up of 367 days [213-467]), SPC initiation was higher in the IC than US (25.1% vs. 9.6%, p<0.001). SBP/DBP decreased by -15.7/-6.9 mmHg in the IC and -10.4/-4.6 mmHg in the UC. Target BP was more often achieved in the IC (57.3% vs. 48.1%; OR: 1.4, 95%CI:1.0-2.1). Among SPC users, SBP/DBP decreased by -22.4/-10.5 mmHg. ConclusionPromoting SPC therapy improved blood pressure control, supporting local, targeted implementation as a pragmatic strategy to enhance hypertension management. Summary box, bullet points- In the SOLO care improvement project, SPC initiation was increased and improved blood pressure control in routine primary care. - The real-world implementation and cluster-based comparison enhanced practical relevance and reduced contamination between practices. - Although conducted in a large community health center, generalizability cannot be assumed; the non-blinded, non-randomized design allows residual confounding.

AimsTo evaluate the effectiveness of the Oishi-kenko mobile cooking application in improving glycemic control, body weight, and dietary behaviors among individuals with type 2 diabetes without professional intervention. MethodsThis 12-week observational study was conducted entirely online. Participants were recruited via the Oishi-kenko website, internet advertisements, and Tsukuba City public relations channels. Of 24,671 website visitors, 214 installed the app, and 65 were included in the final analysis; HbA1c data were available for 24 participants. The app provided personalized, culturally tailored recipe suggestions based on user profiles and dietary standards. Body weight and HbA1c were assessed at baseline and every 4 weeks, and dietary habits were evaluated using the Brief-type Self-administered Diet History Questionnaire (BDHQ). ResultsMean HbA1c decreased from 6.40% at baseline to 6.12% after 12 weeks (-0.28%, P<0.05). Among participants with baseline HbA1c >7%, the reduction was -0.63%. BMI declined from 23.47 to 23.28 overall, with greater reduction among those with baseline BMI [&ge;]25. More frequent app-based cooking and higher baseline HbA1c predicted greater improvement. BDHQ analyses showed reduced intake of salty condiments, noodle soup, and fatty meats, alongside healthier eating behaviors. Over 80% of participants reported improved dietary habits. ConclusionsUse of the Oishi-kenko app was associated with improved glycemic control, modest weight loss, and healthier eating patterns in individuals with type 2 diabetes. These findings support the potential of culturally tailored, stand-alone dietary support applications as scalable tools for diabetes self-management. (The trial registry number: UMIN-CTR, ID: R000053861) HighlightsO_LIOishi-kenko app use significantly reduced HbA1c and BMI in individuals with type 2 diabetes. C_LIO_LIThe study was conducted fully online, from recruitment to data collection, without human intervention. C_LIO_LIParticipants adopted healthier dietary behaviors, including reduced intake of salty condiments, noodle soup, and fatty meats, along with more mindful eating practices. C_LIO_LIThe app shows promise as a stand-alone, culturally tailored digital tool for diabetes self-management without professional intervention. C_LI O_FIG O_LINKSMALLFIG WIDTH=200 HEIGHT=107 SRC="FIGDIR/small/25342210v1_ufig1.gif" ALT="Figure 1"> View larger version (31K): org.highwire.dtl.DTLVardef@771eeborg.highwire.dtl.DTLVardef@8ed68aorg.highwire.dtl.DTLVardef@1a70476org.highwire.dtl.DTLVardef@161b52_HPS_FORMAT_FIGEXP M_FIG C_FIG

Artificial intelligence (AI), particularly large language models (LLMs), is increasingly explored in healthcare, yet its real-world usability and safety in high-risk clinical pharmacy tasks remain uncertain. Vancomycin therapeutic drug monitoring (TDM), which requires precise pharmacokinetic calculations and context-sensitive interpretation within a narrow therapeutic window, provides a stringent test case for AI-assisted decision support. This proof-of-concept study developed and evaluated a hybrid clinical decision support system (TDM-AID) integrating a validated deterministic pharmacokinetic calculation engine, GPT-4o-based structured clinical interpretation, and retrieval-augmented guideline support. Thirty retrospective adult vancomycin TDM cases were assessed using a weighted six-domain rubric covering pharmacokinetic accuracy, AUC estimation, prospective prediction, timing recommendations, clinical judgment, and documentation quality. Two independent expert pharmacists evaluated system outputs against benchmark consultations. The overall median performance was 78% (IQR 12%), classified as Acceptable, and 73% (IQR 14%) when deterministic calculations were excluded. Foundational pharmacokinetic calculations achieved 100% accuracy. Clinical judgment demonstrated Good performance (83%), whereas prospective prediction was limited (58%), and timing recommendations were absent in all cases. Safety violations occurred in 17% of cases, including dose recommendations exceeding 4 g/day. Inter-rater reliability was good (ICC 0.87). These findings suggest that hybrid AI-driven decision support is technically feasible and usable as a pharmacist-augmenting draft generator; however, limitations in predictive reasoning, timing logistics, and safety enforcement necessitate deterministic safeguards and mandatory expert oversight before clinical implementation.

IntroductionPrimary care is facing multiple crises, including an increase in health misinformation. Digital health messaging by primary care providers has been shown to reach a diverse patient population. With the uptake of Generative Artificial Intelligence (GenAI) usage in healthcare, there is an important opportunity to rapidly create messages that are tailored to different populations and conditions. However, thoroughly assessing AI-generated content is essential, as GenAI raises concerns regarding its accuracy, understandability, actionability, and bias perpetuation. We aim to investigate whether digital health messages created by GenAI are evaluated as noninferior compared to those created by human experts. Methods and analysisThe AI-CARE (AI to Create Accessible and Reliable patient Education materials) study is a double-blind, crossover, non-inferiority randomized controlled trial. Data collection began on May 30, 2025, and is expected to be completed at the end of April 2026. Over 12 months, 192 messages on 48 topics will be written: half by primary care and public health experts and half by a GenAI tool (OpenAIs ChatGPT). Review Panels composed of 24 primary care providers and 24 patients will evaluate these messages using an Evaluation Grid developed to assess the messages quality of information, adaptation to the target audience, relevance and usefulness, and readiness to be shared with patients. Evaluations will be completed via online REDCap surveys and the order in which the 192 messages appear will be randomized and will vary between individuals. Participants and analysts will be blinded to the generation source. The primary outcome will be the Clarity and Understandability score. Ethics and disseminationThe Research Ethics Boards of the Hopital Montfort (24-25-11-038) and the University of Ottawa (S-12-24-11153) formally approved this study in December 2024. Reported data will be grouped and anonymized for dissemination in peer-reviewed scientific journals and conferences. Trial registration numberNCT06997107 ARTICLE SUMMARYO_ST_ABSStrengths and limitations of this studyC_ST_ABSO_LIThe AI-CARE study allows for within-participant comparison between human- and AI-generated digital health messages, minimizing variability due to individual differences. C_LIO_LIThe Review Panels are diverse and composed of primary care providers and patients currently practicing in or using the healthcare system in five Canadian provinces. C_LIO_LIThe developed Evaluation Grid allows for the assessment of multiple aspects related to digital health messages: quality of information, adaptability to the target audience, relevance and usefulness, and readiness to be shared with patients. C_LIO_LIOne limitation is that messages generated by AI are created using only one LLM (Open AIs ChatGPT). C_LIO_LIDue to the nature and location of recruitment, we may introduce selection bias (participants already engaged in research and interested in digital communication and AI) and the racial diversity of our study population may be limited. C_LI

Background and ObjectiveBlood pressure treatment response is variable in individual patients, and the choice of medical therapy is often dependent on clinician experience. Treatment choices can be personalised by patient empowerment, metabolomic profiles and augmented by machine learning, but robust evaluation is lacking on how these can be combined to enhance clinical effectiveness. The HYPERMARKER trial will evaluate how an individualised choice of medication class can address the avoidable global health and economic burdens of hypertension. Design and InterventionThe HYPERMARKER trial is a proof-of-concept, pragmatic, multicentre, adaptive, open-label strategy trial embedded into routine clinical practice with stratified individual patient randomisation. The trial was co-designed with a patient and public involvement team. The intervention is a digital portal that supports shared decision making on hypertension therapy class using clinical features plus metabolomic profiles determined with liquid chromatography-mass spectrometry. Participants and OutcomesEligible patients are aged [&ge;]18yrs with a systolic blood pressure [&ge;]140mmHg and a clinical indication for antihypertensive therapy. 400 participants will be randomised to usual standard of care for treatment selection, or to the intervention group. Remote follow-up will occur through a patient smartphone application and linked blood pressure monitor to assess the primary outcome of change in home systolic blood pressure during a four-week period after medication changes. Secondary outcomes will include patient-reported adverse effects and quality of life, treatment withdrawal, healthcare utilisation and a health economic analysis. In the second phase of the trial, all participants will receive an updated version of the intervention, regardless of original randomised group. Ethics and DisseminationEthical approval will be obtained for all sites. Approval in England: North West - Greater Manchester West Research Ethics Committee (REC) (25/NW/0296). Trial results will be disseminated via peer-reviewed publications and plain language patient summaries. Trial registrationClinicaltrials.gov: NCT07294794; ISRCTN: ISRCTN29385951. STRENGTH AND LIMITATIONS OF THIS STUDYO_LIHypertension is a major cause of preventable morbidity and mortality, and this study aims to reduce those burdens through machine learning-based integration of metabolomics with clinical factors to enable better personalisation of blood pressure lowering therapy. C_LIO_LIThe HYPERMARKER trial was co-created with patient and public representatives, using digital technology with remote monitoring to facilitate a high level of shared care and patient empowerment. C_LIO_LIHYPERMARKER is a pragmatic proof-of-concept randomised trial designed to evaluate the potential for future pharmacometabolomic strategies to aid clinical decision-making. C_LI

PurposeRobotic walkers are a new and novel technology with growing evidence of benefits for children living with mobility impairments. However, little is known about how using these devices at home impacts families. This study aims to explore parents perceptions of home-based robotic walking and the impacts on their family and their child living with a mobility impairment. Materials and MethodsQualitative interviews were conducted with seven parents who have a child who used a robotic walker in their home for at least six months. Thematic analysis was used to analyze all interviews. Themes were then mapped to the F-words for child development. ResultsUsing a robotic walker at home led to family bonding and created new ways for parents and siblings to interact with the child living with a mobility impairment. Many children enjoyed using the robotic walker. This, combined with being able to direct its use in their own environments, contributed to less parental stress than was associated with other rehabilitation interventions. However, some parents discussed an increase in parental stress due to certain logistical aspects, getting their child in and out and transporting the robotic walker. Finally, parents discussed that obtaining the device was a financial burden for them. ConclusionRobotic walking in the home environment impacts family relationships and parental stress. Understanding families experiences can inform decision-making by families and practitioners around the appropriateness of robotic walker use for a child living with a disability.

Decentralized clinical trials offer a scalable approach to evaluate patient research in real-world settings. The COSMOS-DIGITAL study (NCT06761703) was designed to assess the feasibility of recruiting patients using antiobesity medications from an online patient community and aimed to evaluate participants willingness to consent to and complete fully decentralized surveys and at-home self-blood testing. Three-quarters (n = 151; 75.5%) of participants completed all self-collected capillary blood samples, Patient-Reported Outcomes in Obesity (PROS) surveys, and nausea-related surveys. Over 83% of participants completed the surveys (PROS: n = 167; 83.5%; daily nausea: n = 168; 84.0%), and 93% (n = 142/152) of collected blood samples were sufficient or partially sufficient for testing. Overall, participants were satisfied with the at-home blood collection device. Digitally enabled, fully decentralized studies can capture blood samples and survey responses as well as important aspects of patient treatment experiences, adding value to data collected in randomized controlled trials.

BackgroundAnticipatory injectable medications for symptom control are a key end-of-life care intervention. However, ensuring their safe and timely use in the community is a global challenge. The needs and priorities of stakeholders involved in processes for prescribing and administering these medications remain underexplored. We must understand these perspectives to design inclusive and adaptive systems. AimTo identify the needs and priorities of key stakeholders involved in community-based systems for using anticipatory injectable medications. DesignWe adopted a qualitative exploratory design, using an online survey between September and October 2024. Participants provided anonymised demographic information and completed up to four prompts capturing their stakeholder role, needs and priorities. Data were analysed using a combined inductive-deductive framework to produce synthesised shortlists of priorities and needs. Setting/participantsUK-based professional and public participants were recruited through social media, professional networks, charities, and public engagement events. ResultsIn total, 439 participants contributed 729 responses across various stakeholder groups. Findings revealed substantial diversity in stakeholder needs and priorities, both within and between groups. However, most stakeholder groups prioritised timely care, minimising of suffering, and wanted nationally consistent guidance for using injectable medications. Broader societal influences also shaped responses. ConclusionsOur findings highlight wide diversity in priorities and needs between stakeholders for using anticipatory injectable medications in the community. We propose that inclusive system design should include comprehensive assessment of key stakeholders needs and priorities, with the aim of providing better care. Our study demonstrates that stakeholder needs assessment offers a valuable framework to achieve this. What is already known about the topic?O_LIAnticipatory injectable medications are a widely used intervention in several countries to support timely end-of-life symptom control at home. C_LIO_LIThere are ongoing challenges with delays, inconsistent access, and variations in prescribing and governance across regions, indicating that system design influences both timeliness and safety. C_LIO_LIExisting research has primarily focused on the needs of individual professional groups, and no prior work has mapped the differing needs of all stakeholders involved in these systems. C_LI What this paper adds?O_LIOur study demonstrates that stakeholder groups have diverse needs but most share some core priorities -timely care, national consistency in practice guidance, and minimising suffering. C_LIO_LIWider societal factors and concerns shape stakeholder expectations of end-of-life medication systems. C_LIO_LIOur approach to stakeholder needs assessment reveals system requirements that consensus-based or single-perspective approaches often overlook. C_LI Implications for practice, theory, or policyO_LISystem improvements should be tailored to the specific needs of key stakeholder groups rather than assuming uniform priorities. C_LIO_LIStrong cross-stakeholder support exists for national, practical guidance on anticipatory prescribing, equipment, training, and governance. C_LIO_LIStakeholder needs assessment offers a useful method for designing safer, more responsive end-of-life medication systems. C_LI