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.

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.

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 [≥]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

Background: Lifestyle interventions incorporating medically-tailored meal delivery may support rapid behavior change among pregnant individuals with gestational diabetes (GDM). Purpose: To examine the feasibility and acceptability of a multicomponent lifestyle intervention for pregnant individuals with GDM. Primary outcomes included recruitment, retention, intervention receipt, and acceptability. Methods: We 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. Results: Of 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. Conclusions: While the Meals4Moms intervention was highly acceptable to participants, procedural refinements are needed prior to conducting a full-scale efficacy trial.

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).

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.

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 ([&ge;]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 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

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 [&ge;]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.

BackgroundOptimal management of Type 1 diabetes (T1D) requires precise insulin dosing and sick-day decision-making; deficiencies in either predispose to hypoglycemia, suboptimal glycaemic control, and diabetic ketoacidosis. We developed DiaBuddy, a guideline-aligned mobile decision support tool, and evaluated its accuracy versus expert guidance and its clinical impact in children with T1D. MethodsThe preclinical validation compared DiaBuddy and family recommendations (N = 37) for 20 insulin-dosing and 20 sick-day vignettes against a pediatric endocrinologist gold standard. The prospective single-arm pilot study evaluated its impact on HbA1c, CGM metrics, and quality of life in 20 children. ResultsIn the preclinical study, DiaBuddy showed lower absolute relative deviation for basal (5.0 {+/-} 6.7% vs 24.2 {+/-} 25.9%), bolus (6.9 {+/-} 10.9% vs 45.3 {+/-} 48.8%), and combined doses (6.3 {+/-} 9.3% vs 39.0 {+/-} 37.8%; all P < 0.001) than families. DiaBuddy achieved [&ge;]90% accuracy across all sick-day domains versus 27-70% for families; adherence would have prevented 94.5% of family errors including all hospitalization decision errors. In the clinical study, HbA1c declined from 9.18 {+/-} 1.99% to 8.48 {+/-} 1.44% (P = 0.049), PedsQL QOL score increased from 76.5 {+/-} 8.6 to 89.1 {+/-} 7.1 (+12.6 points, P < 0.001) with no change in CGM metrics. Application satisfaction was high (mean score 44.1 {+/-} 4.1 out of 50) with 96% wishing to continue using it. ConclusionsDiaBuddy delivers guideline-aligned guidance, substantially outperforming family decisions in preclinical vignette testing and showing preliminary signals of improvement in glycaemic control and quality of life in a small uncontrolled pilot study. The results support the conduct of larger randomised controlled trials.

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.

ObjectiveTo evaluate the effectiveness of a multifaceted lifestyle intervention delivered by patient peers and supported by healthcare workers and technology to achieve control and remission of type 2 diabetes. MethodsOpen-label, cluster-randomised controlled trial conducted in rural Assam, India. Type 2 diabetes patients identified through a screening program in 25 villages (clusters) were randomly assigned to intervention or standard care. At baseline, all participants underwent assessment of diet, physical activity, quality of life, medicine intake, physical measurements and biochemical evaluation. The intervention was a contextually designed package, delivered during fortnightly group counselling by patient-peers and healthcare workers, focusing on carbohydrate-restricted healthy diet, physical activity, diabetes management, and medication de-escalation. Nutrition data were transferred to the study management for suggestions and modifications on smartphones. Intervention was implemented for 3 months, when anthropometric and biochemical parameters were reassessed. Primary outcomes were diabetes control (HbA1c, fasting glucose) and remission (HbA1c <6.5% without medications). Modified intention-to-treat analysis has been performed. Results353 patients in rural locations (intervention=193, standard care=160) were enrolled. Baseline sociodemographic, lifestyle, clinical and biochemical parameters were not different in intervention and standard-care groups. At 3 months, in the intervention vs standard-care group there was significantly lower median (interquartile range) HbA1c 7.9% (7.0-8.7) vs 8.6% (7.6-9.8), p<0.001; and fasting glucose 188.0 mg/dl (146.2-253.5) vs 210.0 mg/dl (166.0-282.0), p=0.001. Diabetes remission was in 9 participants (5.0%) in intervention vs 4 (2.7%) in standard care (p=0.249). ConclusionsPatient-peers delivered and healthcare worker- and technology-supported diet and lifestyle intervention for type 2 diabetes led to significant improvement in diabetes control in rural patients in India. Diabetes remission was observed in a low proportion. Trial registrationRegistered with Clinical Trials Registry of India at www.ctri.nic.in; registration number CTRI/2022/03/041302 dated 22 March 2022. STRENGTHS AND LIMITATIONS OF THE STUDYO_LIMultifaceted diet and lifestyle intervention for type-2 diabetes control and remission, delivered by patient-peers with health worker and technology support, is feasible in rural populations in India. C_LIO_LIThis cluster-randomised trial shows that the intervention led to significantly better diabetes control. Diabetes remission occurred in a small proportion. C_LIO_LILarger and longer prospective studies are required to confirm the effectiveness of such lifestyle strategies for diabetes control and remission in India, lower-middle, and low-income countries. C_LI

BackgroundOlder adults walking has so far been evaluated using standardised assessments of walking capacity within a clinical setting. By taking the evaluation out of the laboratory into the real world, this study provides first evidence of the ability of Digital Mobility Outcomes (DMOs) to detect changes over time and the Minimal Important Difference (MID) in patients after proximal femoral fracture (PFF). This will guide the implementation of DMOs in research and clinical care. MethodsFor this multicenter prospective cohort study, 381 community-dwelling older adults were included within one year after sustaining a PFF and assessed at two time points, separated by six months. Walking activity and gait DMOs were measured using a single wearable device worn on the lower back for up to seven days. A global impression of change question and three mobility-related outcome measures (Late-Life Function and Disability Instrument; Short Physical Performance Battery; 4m gait speed) were used as anchor variables. To assess each DMOs ability to detect changes, we calculated the standardized mean change as effect size. For estimating MIDs, both distribution-based and anchor-based methods were applied, followed by triangulation by experts if at least three anchor-based estimates were available per DMO, resulting in single-point estimates. ResultsAll three anchor variables demonstrated substantial changes. Overall, 10 out of 24 available DMOs showed large and 7 DMOs moderate positive effects in the expected direction of the respective anchors. Seven DMOs showed no or only small effects. For 12 DMOs, at least three anchor-based estimates were available, enabling MID triangulation. MIDs for walking activity DMOs per day were: a walking duration of 10 minutes, a step count of 1,000 steps, 50 walking bouts (WB), and 15 WBs in WBs over 10 seconds. For gait DMOs, depending on the walking bout length, MIDs for walking speed were between 0.04 m/s and 0.08 m/s, and MIDs for cadence between 4 and 6 steps/minute. Almost all DMOs showed a strong ability to detect improvement in mobility, but rarely in detecting decline. ConclusionsFor the first time, MIDs are presented for real-world DMOs in PFF patients. These MIDs inform sample size requirements and interpretation of intervention effects for clinical trials, thereby providing guidance and reassurance for clinicians and regulatory bodies.

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.

IntroductionDespite improvements in treatment for people living with HIV (PWH), adherence remains a challenge for many. In this study we aimed to identify preferences for daily pill or long-acting injectable (LAI) antiretroviral therapy (ART) and for possible treatment package features, among PWH enrolled in Ryan White HIV/AIDS Program Part A (RWPA) Medical Case Management (MCM) programs. MethodsParticipants were recruited from six MCM programs from across the New York RWPA eligible metropolitan area (the five boroughs of New York City and Rockland, Putman, and Westchester counties). We developed a discrete choice experiment (DCE) with four attributes: (1) Type of ART Medication (daily pills or LAI), (2) Service Location and Mode, (3) Support, and (4) Rewards. We used an alternative-specific design in which the levels for the last three attributes were dependent on levels within the first (Type of ART). Latent class multinomial logit analysis (LCA) was used for preference estimation and hypothesis-free investigation of preference heterogeneity. ResultsFrom June 2022 through January 2023, 200 New York RWPA MCM clients completed the DCE. We selected a two-group LCA solution. A majority of participants had a higher preference for LAI regimens compared to daily pills (n=114 [57%] versus n=86 [43%]). Those who preferred LAI ART were younger (median age 49 versus 58.5 years, p<0.001), less likely to identify as straight/heterosexual (69% versus 82%, p=0.03), and more likely to identify as Latino/a (54% versus 30%; p<0.001). Preferences for service locations/mode, supports, and rewards were similar across LCA groups. Participants who preferred LAI ART were more likely to have heard of LAI ART before the survey (59% versus 41%, p=0.012). Overall, only 4% of participants self-reported having tried LAI ART. ConclusionsAssessing preferences among groups under-represented in clinical trials is essential to effective and equitable real-world implementation of innovative treatment options. Our study found that there were distinct groups that differed in their preferred ART regimen type and that New York RWPA MCM clients had limited familiarity with LAI ART. To inform regimen selection, we began pilot-testing educational materials and a patient-provider decision-making tool in 2023.

Introduction"Encompass" is a participatory group-based intervention originating from low- and middle-income countries, co-developed with parents and professionals to enhance the wellbeing, health literacy and empowerment of caregivers of young children with complex neurodisability. We aimed to assess feasibility and acceptability of a) intervention delivery in two socially deprived United Kingdom (UK) urban areas and b) evaluation methods including data collection on programme outcomes and costs. MethodsWe conducted a mixed-methods pilot and feasibility study with caregivers of children under five years with complex neurodisability. Feasibility and acceptability of intervention delivery were assessed based on recruitment rates, group attendance, fidelity checklists and qualitative interviews with caregivers and facilitators. Feasibility and acceptability of evaluation methods were explored through follow-up rates, questionnaire completeness, and caregiver feedback on outcome measures. Data relating to implementation at organisational and system levels were explored through interviews with facilitators and key partners. Results were compared to predefined traffic light criteria (green, amber, red) to determine whether a larger scale evaluation was warranted. ResultsEight caregivers participated in the programme. Fidelity of delivery and follow-up questionnaire completion met green criteria, while recruitment and attendance met amber criteria, indicating that minor adaptations are required before scaling up. Qualitative findings demonstrated high acceptability of the programme among caregivers and facilitators, particularly valuing the co-facilitation model, participatory approach, and peer support. Flexible delivery, including online participation and communication support, enhanced accessibility for families with diverse needs. Capturing programme delivery costs was feasible and provided preliminary estimates to inform future economic evaluation. ConclusionsOur findings provide proof of principle that "Encompass" can feasibly and acceptably be delivered and evaluated with caregivers of children with complex neurodisability in an ethnically diverse UK community health setting. The findings support progression to a larger-scale evaluation, with refinements to recruitment strategies and delivery logistics. Patient or Public ContributionCaregivers with lived experience were central to developing the "Encompass" programme and this study. Four local mothers of children with complex neurodisability contributed to planning, recruitment, and sense-checking the findings.

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 [&ge;]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.

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.

BackgroundEffective interventions are needed to support co-creation of diabetes care plans that fit patients lives. We evaluated the QBSafe agenda-setting kit (14 conversation cards) for its impact on care fit and glycemic control when added to usual primary care. MethodsThis single-center, clinician-level cluster-randomized, open-label trial was conducted at a federally qualified health center in New Haven, Connecticut (ClinicalTrials.gov NCT05553912). Clinicians and their patients with type 2 diabetes and HbA1c >8% were randomized 1:1 to usual care with or without QBSafe cards. In the intervention arm, patients selected up to 3 cards highlighting concerns about life with diabetes prior to their visit. Primary outcomes were change at 6 months in care fit (Illness Intrusiveness Ratings Scale, IIRS) and HbA1c, analyzed by intention to treat. Secondary outcomes were treatment burden (Treatment Burden Questionnaire, TBQ) and diabetes distress (Diabetes Distress Scale, DDS), and satisfaction with visits. ResultsBetween February 2023 and July 2024, 143 participants (mean age 56 years; 61% female; 73% Hispanic; mean HbA1c 10%) were enrolled: 74 received usual care with QBSafe, 69 usual care alone. At 6 months, there were no significant between-arm differences in changes in IIRS (-3.9 [95% CI -10.4, 2.6]), HbA1c (-0.2% [95% CI -0.9, 0.5]), TBQ (1.0 [95% CI -16.6, 18.6]), or DDS (-0.1 [95% CI -0.4, 0.2]). Clinicians reported greater satisfaction when using QBSafe. Patient satisfaction was high and did not differ across arms. ConclusionsQBSafe cards improved clinician satisfaction but did not improve care fit or glycemic control. Future tools should focus on helping clinicians respond effectively to patient-identified challenges.