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Pilot and Feasibility Studies

Springer Science and Business Media LLC

Preprints posted in the last 30 days, ranked by how well they match Pilot and Feasibility Studies's content profile, based on 12 papers previously published here. The average preprint has a 0.02% match score for this journal, so anything above that is already an above-average fit.

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Optimized hypertension care for people with high blood pressure by improved integrated care and self-management tools: a mixed-methods study

van Grondelle, S. E.; van Ede, A. F. T. M.; ter Braake, J. G.; van Bruggen, S.; Rutten, G. E. H. M.; Bots, M.; Vos, H. M. M.; Numans, M. E.; Vos, R. C.

2026-05-25 primary care research 10.64898/2026.05.14.26352728 medRxiv
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Background: High blood pressure (BP) is an often treatable cause of cardiovascular disease. We developed an intervention, featuring a cardiovascular expert team and a toolbox, to support healthcare professionals (HCPs) in hypertension management and enhance patient self-management. Aim: This study evaluates the adoption and feasibility of this intervention. Design and Setting: A mixed-methods study in general practices in the Netherlands. Methods: HCPs could consult a cardiovascular expert team and use a self-management toolbox for their patients as preferred. We interviewed HCPs guided by the Consolidated Framework of Implementation Research (CFIR), and HCPs completed the Determinants of Implementation Behaviour Questionnaire (DIBQ). Using CFIR-ERIC matching tool, we matched implementation strategies to identified barriers. Adults with elevated BP, who were prescribed at least two blood pressure lowering medications were eligible to participate. Patient and disease characteristics were extracted from the electronical medical record. Results: Of 591 eligible patients at thirteen general practices, 176 participated. The cardiovascular expert team was well-received, with 33 unique consultations, although nurse practitioners (NPs) might need the expertise of the expert team more frequently than general practitioners (GP) (adoption). The toolbox was perceived as challenging to use (feasibility). We subsequently identified three key strategies to improve implementation. Mean systolic and diastolic BP were 158/87 mmHg at baseline and 148/85 mmHg after 12 months, although this change cannot be conclusively linked to the intervention. Conclusions: Structured implementation strategies may be helpful in hypertension management. The cardiovascular expert team was considered valuable, but might be better targeted to NPs rather than GPs.

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Using opioid analgesia for chronic pain in adults aged 85+: a qualitative study

Faux-Nightingale, A.; Woodcock, C.; Walker, C.; Smith, H. E.; Welsh, V. K.

2026-06-08 geriatric medicine 10.64898/2026.06.08.26354706 medRxiv
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Background Chronic pain is common in adults aged 85 years and older (85+) and is associated with detrimental outcomes. Chronic pain guidelines advise first line management with non-pharmacological measures; paracetamol and non-steroidal anti-inflammatory drugs are the preferred analgesics. Challenges in accessing non-pharmacological therapies for adults aged 85+, and the presence of multimorbidity and polypharmacy, mean that opioid medication is often prescribed for chronic pain despite the potential for opioid-related adverse effects and guidance identifying long-term opioids for chronic pain as a potentially inappropriate prescription. Aim This study aims to explore patient, caregiver, and healthcare professional perspectives on the prescription of opioid medications for pain management for chronic pain in adults aged 85+ to support development of resources for optimising opioid prescribing. Design and Setting In this qualitative study, participants were recruited through primary care, in the community or in care home settings. Method 36 semi-structured interviews were conducted with care home residents and community dwellers aged 85+ (n=12), caregivers (informal and care home staff) (n=12), and healthcare professionals (n=12). Interviews were transcribed and analysed using reflexive thematic analysis. Results Four themes were developed: contextual complexity, satellite influences, balancing act, and pragmatic prescribing. Using opioids in adults aged 85+ is a balancing act to support patients best possible quality of life within their unique circumstances whilst using the pain management tools available. Conclusion Opioids continue to have an important role in pain management in adults aged 85+ largely due to paucity of alternatives and the drive to support quality of life.

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Feasibility study of a novel, low-cost splint device for children with foot drop

Exell, T. A.; Moore, J.; Wright, A.; Cleverley, S.; Roel Ferreira, J.; Williams, R.; Saynor, Z.

2026-05-15 pediatrics 10.64898/2026.05.07.26352389 medRxiv
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Importance: Foot drop impairs mobility for many children globally, causing life-long health issues. Existing treatments are costly, custom-made, and require frequent clinical visits. A new, low-cost, off-the-shelf splint (OrthoPed) could improve access and user experience. Objective: To determine the feasibility of recruiting children (4-17 years) with moderate foot drop and collecting biomechanical, clinical, and patient-reported outcomes to compare OrthoPed with existing treatments. Design: Single-centre cross-sectional feasibility and pilot study informing a future randomised clinical trial. Participants: Twelve children (target=20; mean age=10.6 {+/-} 3.5 years; 2 females) with moderate foot drop and prescribed orthotic support were recruited via physiotherapy. Intervention: The new OrthoPed splint was compared against existing treatments: ankle foot orthoses (AFOs) and Lycra socks. Main outcome measures: Primary outcome: recruitment and retention rates. Secondary outcomes: biomechanical and clinical gait measures, alongside useability and performance questionnaires. Results: Recruitment reached 22% of eligible participants (an "amber" rating for future trials). Despite four dropouts due to treatment burden, all outcome measures were successfully collected. Preliminarily, OrthoPed supported more natural gait mechanics than AFOs and offered better usability and comfort than AFOs and Lycra socks, potentially enhancing adherence. Conclusions: Recruiting children for orthotic trials is feasible, though coordinating gait testing with routine clinical appointments could improve future recruitment. Importantly, low-cost orthotic devices may provide better usability, accessibility and adherence than existing prescribed options.

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Virtually Delivered Psychosocial Intervention for Mothers Expecting a Baby with Congenital Heart Disease: A Proof-of-Concept Study of HEARTPrep

Sood, E.; Canter, K.; Arasteh, K.; Kazak, A. E.

2026-06-05 cardiovascular medicine 10.64898/2026.06.03.26354861 medRxiv
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Background: Maternal mental health problems are common after prenatal diagnosis of congenital heart disease (CHD), with long-term implications for child and family wellbeing. HEARTPrep is a prenatal psychosocial intervention with three self-paced modules and corresponding telehealth sessions, delivered during pregnancy via mobile app to improve mental health and wellbeing for mothers expecting a baby with CHD. This proof-of-concept study evaluated the feasibility of HEARTPrep and examined maternal mental health and psychosocial functioning throughout participation. Methods: Participants were mothers receiving care for a fetal CHD diagnosis within one health system. Feasibility was assessed via rates of enrollment and completion. Mothers completed 4-item PROMIS questionnaires assessing anxiety, depression, and social isolation and reported self-efficacy and hope on a weekly basis throughout HEARTPrep. Results: Of 34 recruited mothers, 29 (85%) enrolled and two were subsequently not eligible (delivery prior to participation, change in fetal diagnosis), resulting in a final sample of 27 mothers. The majority (n = 22, 81%) completed all three telehealth sessions and Modules 1 (n = 22, 81%) and 2 (n = 19, 70%), with just over half (n = 14, 52%) completing Module 3 prior to delivery. Mean PROMIS depression T-scores decreased from 57.5 to 52.9, and 48% of mothers had a decrease in depression scores exceeding the meaningful change threshold (half standard deviation). The percentage of mothers reporting high self-efficacy increased from 19% to 48%. Conclusions: HEARTPrep is feasible and corresponds with reduced maternal depression and increased self-efficacy, supporting proof-of-concept. A randomized controlled trial is needed to determine whether HEARTPrep improves outcomes compared to a control group.

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Why is team-based hypertension care failing to take hold in Australia? Real-world evidence from primary care

Satheesh, G.; Slater, K.; Trivedi, R.; Clapham, E.; Lopez, F. M.; McCormack, B.; Miranda, J. J.; Mishra, S. R.; Peterson, G. M.; Sarkies, M.; Schutte, A. E.; Chapman, N.

2026-05-26 primary care research 10.64898/2026.05.25.26354005 medRxiv
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Objective: The shortage of general practitioners (GPs) in Australia has intensified interest in team-based care for hypertension, involving pharmacists and nurses. This study explored primary care provider experiences, barriers, and facilitators related to implementing team-based care in Australia. Design: Qualitative study using semi-structured interviews with primary care providers. Methods: We conducted 51 interviews with GPs (n=24), nurses (n=12), and pharmacists (n=15), purposively selected from diverse primary care settings. Analysis combined deductive coding, informed by the Theoretical Domains Framework and Consolidated Framework for Implementation Research, with inductive thematic analysis to identify emergent themes. Results: Interviews demonstrated a predominantly GP-centred care model, with nurse and pharmacist involvement largely confined to supporting roles, including blood pressure measurement, prescription refills, patient follow-up and counselling. Their contributions were constrained by barriers at both practice (e.g., limited GP support, fragmented communication across providers) and health system levels (e.g., limited financial incentives and restricted reimbursement pathways). Despite their critical role in care planning, nurses described being hamstrung by workload and limited direct funding for hypertension-related services. Pharmacists reported unreimbursed blood pressure checks and restricted funding for medication reviews that constrained the sustainability of their hypertension services. Role ambiguity and the absence of standardised protocols on task sharing further limited collaboration, with nurses and pharmacists describing concerns about overstepping professional boundaries. Attitudes towards team-based care ranged from active disregard (outright rejection) to conditional acceptance and occasional active uptake (strong endorsement). Conclusion: Despite clear willingness among nurses and pharmacists to alleviate GP burden, team-based care is rarely implemented in routine practice. Addressing system-level barriers (funding models that incentivise team-based care and standardised treatment protocols that clarify shared workflows), alongside provider-level barriers (stronger awareness and training that normalises task sharing), is critical to support genuine team-based hypertension care in Australia.

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REduction of the lifting Load Among logistics workers through a passive back eXoskeleton. Protocol of the RELAX project, an 18-month in-field controlled intervention study

Jakobsen, L. S.; Skals, S.; Christiansen, D.; Sorensen, J.; Pontonnier, C.; MADELEINE, P.

2026-05-22 occupational and environmental health 10.64898/2026.05.21.26353770 medRxiv
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Background Occupational exoskeletons are used to reduce physical workload and prevent work-related musculoskeletal disorders in physically demanding jobs. Although laboratory studies demonstrate reduced muscle load during simulated manual work tasks, evidence from long-term, real-world implementations remains very limited. The RELAX project aims to investigate the long-term effects of a passive back-support exoskeleton (BSE) during manual order-picking work in a Danish warehouse, focusing on health and socio-economic outcomes. Methods This 18-month controlled in-field intervention study compares outcomes at two warehouse departments: one where workers use a passive BSE and a control group where workers perform work tasks as usual. Approximately 90 full-time workers will be followed during the intervention period with questionnaires, interviews and company-registered performance indicators. Primary outcomes include perceived work intensity and musculoskeletal discomfort, while secondary outcomes include sickness absence, employee turnover, productivity and cost effectiveness. Furthermore, a process evaluation will be conducted based on questionnaires, focus-group interviews, and reported exoskeleton use. Quantitative effects will be analysed using difference-in-difference analysis with generalized linear mixed models to account for repeated measures over time. Employee turnover will be analysed using time-to-event analysis, and qualitative focus-group interviews will be analysed using reflexive thematic analysis to explore implementation processes and contextual factors. Cost-effectiveness and return on investment will be assessed by comparing the investment with potential savings in costs and resource use. Discussion By combining longitudinal quantitative outcomes with qualitative process evaluation, the study seeks to provide ecologically valid evidence on the effectiveness, feasibility and sustainability of occupational exoskeleton implementation. This approach will help clarify whether long-term exoskeleton use improves worker health without compromising productivity and may inform future workplace guidelines and large-scale adoption strategies.

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Healthcare professionals' perspectives on a multilevel cardiovascular risk management intervention (PROSPERA programme)

Bongaerts, V. A. M. C.; van Gestel, L. C.; van Peet, P. G.; Vuijk, M.-L. S.; Hageman, S. H. J.; Dorresteijn, J. A. N.; Bonten, T. N.; Numans, M. E.; van Os, H. J. A.; Vos, R. C.

2026-06-09 cardiovascular medicine 10.64898/2026.06.08.26355169 medRxiv
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Background: Two-thirds of Dutch cardiovascular risk management (CVRM) for patients at risk of cardiovascular disease is delivered in primary care practices. While individual risk scores are increasingly used during consultation, a population-level structure for risk-based patient outreach is not currently available. We therefore developed the PROSPERA programme, a multilevel intervention comprising population-level risk stratification and individual-level support tools. Aim: To assess anticipated and experienced barriers and facilitators among healthcare professionals (HCPs) to inform implementation in primary care. Methods: We conducted four focus groups and six interviews with nine primary care HCPs to explore anticipated and experienced barriers and facilitators. Inductive codes were thematically analysed and assigned to corresponding domains of the Theoretical Domains Framework (TDF) and the related Capability, Opportunity, Motivation model of Behaviour. Results: Barriers and facilitators were identified in 11 TDF domains. Population-level barriers included altered professional roles and limitations in technological infrastructure. Individual-level barriers were limited skills in interpreting risk calculations and difficulty integrating tools into clinical routine. Facilitators were related to beliefs on the importance of providing proactive care (population level), the use of U-Prevent for risk communication (individual level) and positive patient responses to the Lifestylecheck questionnaire (individual level). Conclusion: Addressing barriers and facilitators identified at both the population and individual levels can support implementation of the PROSPERA programme. Opportunities exist in education and training of HCPs in risk communication, as well as support in restructuring the physical and digital environment.

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Communication of Cardiovascular Disease Risk and Prevention Strategies at the Healthy Lifestyle Centres- reality vs expected quality: A cross-sectional mix-methods study

Ranasinghe, L. I.; Ranasinghe, S.; Lakshitha, C.; Tennakoon, S.

2026-06-03 primary care research 10.64898/2026.06.01.26354657 medRxiv
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INTRODUCTION In the multiple-risk approach of cardiovascular disease management, communication of cardiovascular disease risk and its prevention play a significant role. in Sri Lanka, this function is conducted via Healthy Lifestyle Centres. METHODOLOGY A clinical audit was conducted to describe communication quality in 79 healthy lifestyle centers. A checklist developed based on Patient-Centered Communication Tools with the support of an expert panel. Two trained observers independently conducted the observations while the healthcare provider at the Healthy Lifestyle Centre revealed details of cardiovascular disease risk communication and health education sessions. RESULTS: The majority of Healthy Lifestyle Centers involved patients in decision-making (n = 228, 92.0%), explained patient choices (n = 230, 92.8%) and responded to patients' interest in decision-making (n =2 35, 99.2%). Most patients received a summary (n =159,67.1%), a follow-up plan (n =212,89.5%) and were communicated in a jargon-free language (n =127,53.6%). The majority of sessions demonstrated satisfactory use of examples (95.7%, n = 22), and responsiveness to questions (73.9%, n =17). However, most sessions were unsatisfactory regarding provision of a follow-up plan (95.7%, n = 22), encouragement of questions (95.7%, n = 22), allowing clients to talk (87.0%, n = 20), and active listening (69.6%, n = 16). CONCLUSIONS: Strengthening healthcare worker training in patient-centred communication especially shared decision-making, active listening, and encouraging patient questions are essential to improve cardiovascular disease risk communication and patient adherence to preventive guidelines at Healthy Lifestyle Centres. Key words Communication, Cardiovascular disease risk, health communication, effective communication, paternalistic healthcare

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Climate change and environmental pollutants - an international survey of naturopathic perceptions and clinical behaviour

Foley, H.; Lloyd, I.; Fitzpatrick, M.; Steel, A.

2026-06-02 occupational and environmental health 10.64898/2026.05.31.26354564 medRxiv
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Background: With rising concerns about health impacts from climate change and environmental exposures, planetary health approaches are increasingly prominent, considering connections between human health and that of the natural environment. Naturopathy is an holistic traditional medicine system characterised by philosophies and practices rooted in nature that theoretically align with planetary health. However, it is unknown to what extent these philosophies translate into consideration of relevant factors during patient care. This study describes the perceptions and clinical behaviours of the global naturopathic workforce in addressing the health impacts of climate change and environmental pollutants. Methods: A cross-sectional online survey was administered to an international sample of naturopathic practitioners, recruited through communications from World Naturopathic Federation member organisations. The survey utilised the Climate Change Perceptions Scale, and asked participants about their perceptions of the health impacts of climate change and environmental pollutants. The survey also examined participant considerations of factors relating to climate change and environmental pollutants during clinical case assessment and prescribing of treatments. Data were descriptively analysed. Results: Of n=363 naturopathic practitioners who completed the survey, 88.7% agreed climate change is real, of whom the majority were concerned about impacts of climate change on their patients' health (89.1%). Almost all participants agreed that environmental pollutants harm human health (99.7%) and were concerned about impacts on their patients (99.5%). Climate-related health factors such as water intake (74.2%) and food security (72.9%) were frequently considered during patient assessment, while impacts of severe weather events (41.4%) were less commonly considered. Consideration of factors relating to environmental pollutants was more commonly reported, particularly for food quality (83.8%) and domestic/indoor sources of pollutants (73%). When formulating prescriptions, participants reported highly frequent consideration of all climate-related factors (73%-86.8%) and varied consideration of environmental pollutant exposures (54.4%-83.4%). Conclusions: The global naturopathic workforce demonstrates a high level of awareness and engagement with factors relating to health impacts of climate change and environmental pollutants, suggesting alignment with planetary health. While this engagement is evident in clinical behaviour, some gaps between awareness and application suggest a need for greater support to strengthen the naturopathic application of planetary and environmental health.

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Efficacy of the PragmaVAC Manual Negative Pressure Wound Therapy Device to Treat Acute Traumatic Wounds in a Conflict Setting: A Retrospective Cohort Study from Gaza

Ramadan, I.; Hariri, M.; Shalakhti, O.; Alawa, J.; Godier-Furnemont, A.; Traboulsi, A. A.-R.; MOWAFI, H.

2026-06-10 surgery 10.64898/2026.06.04.26354740 medRxiv
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Abstract: Background: Acute war-related traumatic wounds present significant challenges due to significant soft-tissue damage/loss, risk of contamination, limited access to antimicrobial therapy, need for delayed closure, and limited access to surgical and wound care. Negative Pressure Wound Therapy (NPWT) has been used effectively to reduce the volume of soft-tissue defects, edema, and infection in traumatic wounds, and to promote growth of healthy granulation tissue. However, conventional NPWT devices are costly and electricity-dependent, limiting their utility in conflict settings. Methods: This retrospective cohort study evaluated the use of PragmaVAC, a manually operated, electricity-independent NPWT device, in patients across three hospitals in Gaza with conflict-related wounds that were deemed by the treating surgeon to be unsuitable for primary closure. Secondary analysis was performed of clinical records of patients treated with the PragmaVac NPWT device to assess ability to achieve a primary outcome of wound bed with healthy granulation tissue, time to primary outcome, and rates of adverse effects. Secondary outcome of wound closure and closure method was also assessed. Results: Treatment with PragmaVAC manual NPWT was prescribed to 88 patients. Of those, 27 (31%) had incomplete documentation of their wound healing or were lost to follow up. The remaining 61 (69%) had complete documentation of their wound healing, complications, and final outcome with 59 (67%) successful closure and 2(2%) failure. Conclusion: The use of the PragmaVAC NPWT device provided a safe, effective wound care option to achieve wound closure for large conflict-related traumatic wounds in resource-limited settings. Future studies may further evaluate such use through prospective trials, evalutions of patients' experiences with manual NPWT, and evaluating outcomes beyond primary wound closure to include medium- and long-term complications, cosmesis, and cost of therapy.

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Development and Pilot Testing of a Mobile App Psychosocial Intervention for Psychological Distress in Individuals with Glaucoma

Fisher, H. M.; Chou, N. A.; Falkovic, M.; Parnell, H.; Makarushka, C.; Fish, L. J.; Plumb Vilardaga, J.; Medeiros, F. A.; Somers, T. J.; Muir, K. W.; Berchuck, S. I.

2026-05-22 ophthalmology 10.64898/2026.05.20.26353674 medRxiv
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Objective: To assess the feasibility and acceptability of VISON-ACT, a standalone, mobile app psychosocial intervention for psychological distress in individuals with primary open-angle glaucoma (POAG). Design: Single-arm pilot. Participants: Patients (N=28) with a diagnosis of POAG, self-reporting at least mild (>3) distress on the 4-item Patient Health Questionnaire, were recruited from the Duke Eye Center between April 2025-December 2025. Methods: Patients (n=28) were consented and completed a baseline (A1) self-report assessment. VISION-ACT was comprised of 6 weekly modules. Follow-up self-report assessments occurred at post- (A2) and 1-month post-intervention (A3) and included measures of psychological distress, vision and health-related quality of life, psychological flexibility, disease acceptance, self-efficacy for symptom management, mindfulness, and social support. Participants were invited to complete an exit interview at 1-month post-intervention to gather qualitative feedback on the VISION-ACT protocol. Descriptive statistics were used to assess feasibility and acceptability metrics and patterns of pre-post change on patient reported outcomes were explored with linear mixed mdels using R Statistical Software. Main Outcome Measures: Feasibility (target accrual (n=25) in 12 months, <20% attrition at post-intervention); Acceptability (>75% reporting use of VISION-ACT skills or ideas at post-intervention, >80% reporting M>3.00/4.00 at post-intervention on the Client Satisfaction Questionnaire); Psychological Distress (Hospital Anxiety and Depression Scale [HADS], Subjective Units of Distress Scale [SUDS]). Results: VISION-ACT was highly feasible; accrual target was surpassed (N=28) in 6 months, and attrition was low (3.85%) at post-intervention (A2). Acceptability was strong with 100% of participants reporting use of VISION-ACT skills or ideas at A2 and M=3.27/4.00 intervention satisfaction. Adherence was remarkable with 88.5% of participants completing all six VISION-ACT modules. Pre-post change patterns were in the expected direction for psychological distress (HADS A1 M=13.88, A2 M=11.21; SUDS A1 M=35.54, A2 M=26.46) and all other patient-reported outcomes across baseline, post- and 1-month post-intervention assessments. Data on participant perspectives highlighted valuable aspects of VISION-ACT, and areas for refinement. Conclusions: Robust feasibility and acceptability data seen here provide support a fully-powered, randomized trial to evaluate the efficacy of VISION-ACT for reducing psychological distress and improving related patient-reported and clinical outcomes.

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Exploring Auditory Biofeedback Paradigms for Gait Training in Children with Cerebral Palsy: A User-Centered Design Study

Kantan, P. R.; Hansen, M. B.; Foldager, J. J.; Fjeldgaard, F. S.; Dahl, S.; Spaich, E. G.

2026-05-29 rehabilitation medicine and physical therapy 10.64898/2026.05.29.26353852 medRxiv
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Purpose: To identify, through iterative user-centered design, the auditory biofeedback requirements and sound preferences supporting gait training in children with cerebral palsy (CP), and to determine which feedback variables, sound mappings, and sound types yield clinically viable and movement-interpretable paradigms. Methods: The iterative process spanned two prototype phases. Prototype A comprised seven paradigms demonstrated to two experienced physiotherapists (Workshop 1A). Two of these were subsequently discarded owing to poor sound-movement interpretability and two were modified. Six paradigms were added to Prototype B, demonstrated to four children, five parents, and one therapist (Workshop 1B) and two therapists (Workshop 2B). Data were analyzed using systematic text condensation. Results: Within-child sound preferences varied with energy level and sensory state on a given day. Sound-movement interpretability tended to suffer for paradigms with greater acoustic complexity (e.g. computer-generated music). Therapists endorsed a repertoire spanning both movement quality and movement quantity targets. Participants independently proposed paradigms rewarding restrained and controlled movement, a feedback category absent from the current prototype. Conclusions: Session-level calibration is preferable to fixed sound profiles, requiring real-time interface support for paradigm adjustment. Acoustic complexity must remain subordinate to movement-sound interpretability. Paradigms targeting movement restraint are a development priority unaddressed in the literature.

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Integrating a Non-Communicable Disease Care Cascade within Ghana's Community-Based Health Planning and Services (CHPS) Program: the COMBINE Pilot Implementation Trial

Heller, D. J.; Elkersh, Y.; Nonterah, E. A.; Kuwolamo, I.; Horowitz, C. R.; Alvarez, E. E.; Awine, T.; Govindarajulu, U.; Squires, A. P.; Aborigo, R. A.

2026-06-05 primary care research 10.64898/2026.06.03.26354834 medRxiv
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Introduction: Hypertension is the world's leading cause of death, and depression its leading cause of disability. Control rates for these noncommunicable diseases (NCDs) are low in low and middle-income countries (LMICs). Many LMICs have programs to screen and treat underserved communities for infectious diseases, but evidence to adapt them to treat NCDs is limited. We developed and tested a non-communicable disease program through Ghana's Community-Based Health Planning and Services (CHPS) primary care initiative. Methods: We trained 8 CHPS nurses to diagnose and treat hypertension and depression through door-to-door screening and pharmacotherapy. Physician assistants provided telehealth supervision. We combined this treatment with volunteer counseling to boost medication adherence, improve mood, and change health behaviors. We called the 90-day intervention the CHPS Opportunity for Mentally and Behaviorally Integrated NCD Engagement (COMBINE). Results: We recruited 60 adults from 580 screened: 37 with hypertension (mean blood pressure (BP) of 149/91 mm Hg) and 23 with depression (mean physician health questionnaire (PHQ-9) score of 13.3). After 90 days, 57/60 (95%) completed the intervention: 32/37 (86%) achieved blood pressure control (mean BP 122/75 mm Hg), and 19 of 20 (95%) achieved depression control (mean PHQ-9 score 2.0). After 12 months, 51/60 were retained: 33/37 with hypertension (89%) and 18/23 with depression (78%), with a mean BP of 121/75 and PHQ-9 score of 1.4 respectively. All 51 (100%) achieved disease control at 12 months. 5 persons left by migration and 4 by escalation to higher-level care. Conclusions: The COMBINE model achieved high levels of diagnosis, care retention, and disease control, with minimal adverse events, in a remote setting with limited usual NCD care. This model suggests a novel means to improve the care cascade for these and other noncommunicable diseases through existing non-physician care models in LMICs, warranting further controlled testing at scale.

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Assessment of safe wheeled walker use in frail older adults: Development of a video-based rating instrument

Leonhardt, R.; Lindemann, U.; Schneider, M.; Rapp, K.; Klenk, J.

2026-06-08 geriatric medicine 10.64898/2026.06.04.26354904 medRxiv
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Background: Wheeled walkers can improve safety during walking, but improper use may increase fall risk among frail older adults. No suitable tool exists to assess safe indoor wheeled walker use in this population. This study aimed to develop and validate a video-based expert assessment tool. Methods: Based on the literature and expert consensus, seven problematic indoor situations were identified, and an assessment tool with five safety criteria per situation was developed (maximum score = 35). Fifty participants (mean age 83.9 years, 64% women) from a geriatric rehabilitation clinic and a nursing home were video-recorded while using a rollator. Expert ratings were compared with nursing staff ratings, self-ratings, and the Timed Up and Go test to evaluate validity. Intra- and inter-rater reliability were determined from independent ratings by two physiotherapists and a repeated expert rating after seven days. Sensitivity to change was assessed after two weeks of rehabilitation, and feasibility by the time required for assessment. Results: The expert score of rater 1 at baseline was 28.5 points, and assessment required a mean of 17.5 minutes. Intra-rater reliability was excellent (ICC = 0.98) and inter-rater reliability was good (ICC = 0.80). Validity analyses showed the strongest association with nursing staff assessments (r = 0.74) and a moderate association with the Timed Up and Go test (r = -0.45). After two weeks, patients improved by an average of 2.38 points (8.4% of baseline score). Conclusions: The new instrument demonstrated high reliability, acceptable validity, sensitivity to change, and good feasibility for assessing safe wheeled walker use in frail older adults. Trial registration number and date of registration: DRKS00038358, 07/11/2025

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How nurses spend their time: nurses' experiences and time use for providing HIV treatment under conventional and differentiated service delivery models in South Africa

Lekodeba, N. A.; Pascoe, S. J. S.; Huber, A. N.; Ngcobo, N.; Morgan, A. J.; Ntjikelane, V.; Marri, A. R.; Sande, L.; Shumba, K.; Mokhele, I.; Nichols, B. E.; Jamieson, L.; Rosen, S.

2026-06-08 hiv aids 10.64898/2026.06.06.26355033 medRxiv
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Introduction: Differentiated service delivery (DSD) models aim to reduce time healthcare providers spend with DSD clients, increasing time available for non-DSD clients. We measured nurses' time allocation and explored their experiences with DSD models in South Africa. Methods: We conducted time and motion observations and surveyed nurses at 24 public primary healthcare facilities across two SENTINEL study rounds (09/2022-07/2023 and 11/2023-07/2024). We report median time nurses spent by activity, model of care, and interaction type. Log binomial regression investigated factors associated with high direct nurse-client interaction (above median minutes) and extended work-days ([&ge;]9 hours), and estimated adjusted risk ratios (aRR). Survey questions were related to client care, additional time availability, and policy changes post DSD implementation, with key themes presented alongside illustrative quotes. Results: 176 nurses (88% female, median age 44) were observed for 344 working days; of these, 60 (34%) participated in the provider survey. Nurses spent a median of 293 minutes (53% of their work-day) on direct nurse-client interaction, 89 minutes (22%) on client-support or facility-related tasks, and the remainder on other activities including personal breaks. Time spent per client was similar across conventional care clients (11 [IQR: 8-15] minutes) but ranged between 9 (7-13) to 11 (8-15) minutes for DSD clients; number of direct nurse-client interactions did not differ meaningfully. Nurses at facilities with 2,000-3,999 total remaining on ART (TROA) (aRR 1.56, 95% CI: 1.02-2.37) and in urban areas (aRR 1.43, [1.08-1.89]) had more direct nurse-client interactions than those at facilities with <1,999 TROA and in rural areas, respectively. Nurses at facilities with 4,000+ TROA (aRR 2.22, [1.36-3.63]) and those observed in SENTINEL 3.0 (aRR 1.53, [1.13-2.07]) were more likely to work standard or longer workdays than those at lower TROA facilities (<1,999), those in SENTINEL 2.0 and urban areas. Nurses reported DSD models improved client care (90%), freed up time (60%), and changed clinic procedures and policies (60%). Conclusions: While DSD models did not significantly reduce direct nurse-client interaction time, nurses reported improved client care and gained additional time. DSD impact may vary by facility context. As DSD implementation expands, effective time reallocation may enhance facility performance and provider productivity.

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Investigating the Readability, Visual Design, and Quality of Online Written Pharmacogenomics Health Information for Health Consumers in Australia

Giblett, M. J.; Babikian, Y.; Jhala, D. J.; Medland, S. E.

2026-05-29 health informatics 10.64898/2026.05.27.26354169 medRxiv
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Pharmacogenomics (PGx) offers a pathway towards personalised medicine, which relies on health consumer involvement in making informed decisions. As consumers increasingly seek health information online, high-quality digital resources are essential to support informed consent and shared decision making. The complexity of PGx and widespread limitations in health literacy raise concerns about whether existing consumer-facing online PGx resources are understandable and sufficiently comprehensive. This study evaluates the readability, visual design, and informational quality of publicly available online written PGx health information. Twenty-three webpages met inclusion criteria. The mean readability corresponded to approximately 15 years of formal education (university level), substantially exceeding the Australian Government's recommended Year 7 reading level for public health materials. Informational quality was generally low, with most webpages being rated as poor or very poor. In contrast, visual design quality was relatively strong, with webpages achieving on average around three-quarters of the criteria. Although the visual presentation of PGx webpages is generally professional, their high reading difficulty and limited discussion of treatment choices and uncertainties reduce their usefulness for health consumer education. Improving readability, clearly communicating risks and limitations, and incorporating decision-support features may enhance the ability of online resources to support informed consent and shared decision making.

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Preferences for PrEP service delivery among adolescent girls and young women in remote villages in Lesotho: a discrete choice experiment

Williams, A.; Strauss, M.; Prunas, O.; Gerber, F.; Raeber, F.; Sanchez-Samaniego, G.; Saavedra, E.; Crankshaw, T.; George, G.; Motlalentoa, M.; Mofilikoane, L.; Mohasoa, M.; Gupta, R.; Sematle, M.; Khomolishoele, M.; Grimm, P.; Ayakaka, I.; Tarumbiswa, T.; Marake, N. B.; Phate-Lesihla, R.; Weisser, M.; Amstutz, A.; Labhardt, N. D.

2026-06-03 hiv aids 10.64898/2026.05.27.26352981 medRxiv
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Introduction: Adolescent girls and young women (AGYW) in southern Africa are disproportionately affected by HIV. Despite increasing availability of HIV pre-exposure prophylaxis (PrEP), uptake and sustained use remain low. Existing service delivery models may not adequately meet the needs of AGYW, particularly in remote settings. We conducted a discrete choice experiment (DCE) to assess preferences for PrEP service delivery among AGYW living in Lesotho, a country with one of the highest HIV incidence rates globally. Methods: The DCE was conducted among AGYW (16-24 years) in two districts in Lesotho. Participants completed a series of binary choice tasks comparing hypothetical PrEP service delivery scenarios defined by six attributes: service location, provider type, provider characteristics, provider confidentiality, PrEP product type, and the combination of additional prevention services offered. Preferences were analysed using mixed logit and latent class models. Results: A total of 537 AGYW (median age 19 years, IQR 17-22) were included. Provider confidentiality was the strongest driver of choice, with non-confidential providers significantly less preferred ({beta} = -0.58; 95% CI -0.69 to -0.46). Compared with nurses, services delivered by ComBaCaL CHWs were preferred (0.17; 0.01 to 0.33), while those provided by doctors were less preferred (-0.15; -0.30 to 0.00). Younger female providers were preferred over older female providers (0.20; 0.04 to 0.36). Compared with the daily oral pill, both the 2-monthly injectable (-0.24; -0.39 to -0.08) and the vaginal ring (-1.02; -1.20 to -0.82) were less preferred. Differences in preferences were observed across age groups and districts. Latent class analysis identified two preference profiles, indicating variation in preferences for delivery and product characteristics. Conclusions: Preferences for PrEP delivery among AGYW in Lesotho were strongly influenced by provider confidentiality. Among some AGYW, there was openness to decentralised delivery, particularly through CHWs and community-based models, which may reduce access barriers in remote settings. Product preferences were varied, and not all options were acceptable. Differences by age group and district indicate that no single delivery model will meet all needs. Building on the current standard of care, offering acceptable options in accessible and confidential ways may support PrEP uptake.

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Don't stop the heart: a performance analysis of large language models and potassium dosing

Blotske, K.; Zhao, X.; Henry, K.; Murray, B.; Gao, Y.; Smith, S. E.; Wayne, N.; Ku, P.; Smith, B.; Moua, S.; Sikora, A.

2026-06-04 pharmacology and therapeutics 10.64898/2026.06.02.26354762 medRxiv
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Background: Electrolyte replacement is ubiquitous in the acute care setting, but its familiarity cannot belie that even small dosing errors with potassium can cause lethal cardiac arrhythmias. Recently, MedAgentBench offered a benchmark for agentic artificial intelligence (AI) including the ability to correctly dose potassium based on a single rule; however, this does not adequately reflect the clinical complexity or safety concerns of an agent that has been used as the lethal injection. The purpose of this analysis was to a probe leaderboard large language model (LLM) capabilities to follow basic dosing rules to safely replace potassium in a series of clinician-annotated cases. Methods: Using a clinician panel, we developed a series of dosing principles and 20 clinical cases reflective of the complexity of potassium replacement. External clinicians were surveyed to assess practice variability and agreement to clinician panel answers. We tested GPT-5-chat with each case in triplicate, with and without the clinician curated dosing principles, and prompted the model to answer six questions involving potassium goals, dosing, route, lab frequency, concurrent interventions, and the model's perceived level of confidence for the output and complexity of the case. The primary outcome was the rate of appropriate recommendations in comparison to clinician answers. Results: A total of 54 clinicians reviewed the 20 hypokalemia cases and hypokalemia dosing guideline. Clinicians expressed "highly agree" or "somewhat agree" for 66.8% of the cases evaluated when asked if they agree with the guideline-recommended management. When given the potassium dosing guideline, total errors dropped from 165 to 104, and average accuracy improved from 45% to 65% with GPT-5-Chat. GPT-5-Chat conveyed a high level of confidence for 100% of responses, while labeling 80% and 76% of cases as highly complex with and without the criteria, respectively. Potential harm scores were considerable in both groups, however, a notable reduction in severity scores occurred with the dosing guidance document. Recommendations on concurrent interventions and dosing had the highest rate of errors in both groups. Conclusions: Benchmarks must appropriately reflect clinical complexity to be considered valuable for the deployment of agentic artificial intelligence tools in the healthcare domain. GPT-5-Chat assessment on a comprehensive medication management task for potassium replacement showed improvement with dosing guidance, yet unfit benchmarking performance.

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Long-Term Daily Chlorhexidine Foot Cleansing Reduces Staphylococcal Burden on the Feet of People with Prior Diabetic Foot Complications

Bode, M.; Lydecker, A.; Robinson, G.; Roghmann, M.-C.; Kalan, L.

2026-05-19 dermatology 10.64898/2026.05.14.26352248 medRxiv
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Background: Microbiota dysbiosis of the skin has been implicated in ulcer formation. Individuals with diabetes remain at high risk for diabetic foot ulcers (DFUs) even after ulcer healing. Topical chlorhexidine gluconate (CHG) is a broad-spectrum antiseptic commonly used to reduce microbial burden. In a prior randomized clinical trial comparing daily CHG foot treatment with soap-and-water treatment, no statistically significant reduction in new DFUs was observed, prompting evaluation of whether CHG produced durable changes in the skin microbiota. Objective: To compare changes in foot skin microbiota (including bacterial bioburden, diversity, and community composition) associated with daily CHG versus soap-and-water use over one year in people with diabetes and prior foot complications. Methods: In a single-center, double-blind, placebo-controlled randomized trial, 87 participants were randomized to daily CHG wipes or soap-and-water wipes for 12 months. Foot swabs were collected at baseline, 3 and 12 months, and 4 weeks post-treatment. Bacterial bioburden was quantified. Microbiota composition was assessed using 16S rRNA and ITS amplicon sequencing. Key Results: CHG treatment significantly reduced bacterial bioburden, increased microbial diversity, and altered community composition, including sustained reductions in Staphylococcus abundance. Several microbiota changes persisted more than 4 weeks after treatment cessation. Soap-and-water treatment showed similar but smaller and largely nonsignificant trends. Conclusions: Daily CHG use durably modifies foot skin microbiota in high-risk individuals with diabetes. However, this alone may be insufficient to prevent new foot complications, highlighting the need for additional interventions. These findings have implications for long-term CHG use in populations at risk for staphylococcal infections.

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Neurodiversity in the Paediatric Chronic Pain Clinic: An Audit

Buechner, H.; Themistokleous, G.; Orr, M.; Lawson, E.; Smart, E.; Donaghy, A.; Wallace, E.

2026-06-03 pediatrics 10.64898/2026.06.02.26354725 medRxiv
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Objective: To compare the characteristics, management and outcomes of neurodivergent (ND) children with neurotypical (NT) children attending a chronic pain clinic. Design: An audit of all patients attending the clinic from 2010-2025 using electronic patient records. Setting: A tertiary pain centre in Scotland. Patients: 724 patients were included in the analysis, 193 (26%) were neurodivergent. Patients were included if they had a documented referral to the pain clinic and attendance to at least one clinic appointment. Patients were excluded if no pain clinic letter could be found on their records. Results: There was a significant increase in the percentage of children with neurodiversity attending the chronic pain clinic compared to neurotypical children (p = 0.004) accounting for over a third of children last seen in the period of 2023-2025. ND children were most likely to present with musculoskeletal pain compared with NT children (p = 0.033) representing over half of all ND children's presentations with pain. ND children were more likely to report being bedbound (18% ND, 13% NT, p = 0.0352) or needing a walking aid (40% ND, 25% NT, p = 0.000) due to chronic pain and had a higher number of referrals (ND median = 18.4, 1QR, NT median = 12.44, IQR10.28 p = 0.000). ND children were more likely to live in areas of deprivation (Cochran-Armitage test, Z -2.15, p = 0.0315). Conclusions: Children with neurodiversity are overrepresented in the chronic pain clinic, and more often present to tertiary services with musculoskeletal pain. They are more likely to have multiple referrals, spend longer with the pain service and less likely to be discharged due to pain improvement. These findings highlight the need for focused strategies to address chronic pain in neurodivergent children. Services should consider how best to identify and support children with neurodiversity and chronic pain. Key Messages {middle dot} What is already known on this topic: While there has been research regarding the role of neurodiversity in pain perception, there are gaps in knowledge regarding the influence of neurodiversity on the development and persistence of chronic pain in children. {middle dot} What this study adds: A growing proportion of neurodiverse children attended the pain clinic. Neurodiverse children presented with more severely impactful pain, they spent a longer duration of time within the pain clinic and were less likely to be discharged due to pain improvement. {middle dot} How this study might affect research, practice or policy: Identifying neurodiverse children as a patient group with distinct requirements may prompt adaptations in chronic pain management practices. This audit provides an initial framework for subsequent research.