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Pilot and Feasibility Studies

Springer Science and Business Media LLC

Preprints posted in the last 7 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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Effects of Glucagon-Like Peptide-1 (GLP-1) Agonists on Surgical Wound Healing: A Single Institution Pilot Study

Adams, J. C.; Pullmann, D.; Belostotsky, H.; Mestvirishvili, T.; Chiu, E.; Oh, C.; Rabbani, P. S.

2026-04-22 surgery 10.64898/2026.04.21.26351321 medRxiv
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ObjectiveThis study evaluates the impact of systemic GLP-1 receptor agonist (GLP-1RA) use on surgical wound healing in high-risk surgical populations, including patients with diabetes, and implications for perioperative planning and healing outcomes. ApproachThis pilot retrospective cohort study compared adult surgery patients with non-healing postoperative wounds by their GLP-1RA use. Outcomes included healing status, time to wound closure, and number of surgical interventions. ResultsThe cohort included 35 non-GLP-1RA users and 16 GLP-1RA users with comparable baseline characteristics, except for significant higher prevalence of venous insufficiency among users. Though median time to closure was similar for all patients, users required fewer surgical interventions and their wounds reached closure in significant difference from non-users. Among patients with diabetes, all GLP-1RA users healed significantly compared to non-users. InnovationThe impact of GLP-1RA therapy on wound healing in high-risk reconstructive and soft-tissue surgery remains poorly defined. This pilot cohort addresses that gap, offering an early signal that GLP-1RA use is associated with improved wound healing and fewer postoperative interventions. These findings may inform perioperative practice by identifying a systemic pharmacologic factor that optimizes surgical outcomes in high-risk populations. ConclusionGLP-1RA use was associated with higher healing rates and fewer interventions, particularly among patients with diabetes. These findings support a beneficial role in surgical wound healing and warrant larger multi-site studies.

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Pilot Feasibility Clinical Trial of Virtual Reality for Pain Management During Repeated Pediatric Laser Procedures: Study Protocol for a Randomized Clinical Trial

Armstrong, M.; Williams, H.; Fernandez Faith, E.; Ni, A.; Xiang, H.

2026-04-22 dermatology 10.64898/2026.04.21.26351381 medRxiv
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BackgroundLasers have wide applications in medicine and dermatology, but are associated with pain and anxiety, particularly in younger patients. Pain mitigation is often limited to topical anesthetics in the outpatient setting. Distraction techniques are limited by the need for ocular protection, which can include adhesive eye patches that can completely occlude vision. Virtual reality is effective at managing procedural pain and anxiety under other short medical procedures and is a promising tool for this population. ObjectiveThis trial aims to assess the safety, feasibility, and efficacy of Virtual Reality Pain Alleviation Therapeutic (VR-PAT) for pain management during outpatient laser procedures. Methods40 patients requiring outpatient laser therapy for at least two sessions will be recruited from a pediatric hospital in the midwestern United States for this crossover randomized, two-arm clinical trial with a 1:1 allocation ratio. During the first laser visit, the participant will be randomly assigned to either play the VR-PAT game during their procedure or wear the headset with a dark screen. Participants will answer questions about their pain (Numeric Rating Scale (NRS) 0-10), anxiety (State Trait Anxiety Inventory for Children, NRS 0-10, Modified Yale Preoperative Anxiety Scale (mYPAS)), and pain medication usage. Those playing the VR-PAT will additionally report simulator sickness symptoms and their experience playing the game. At their second laser visit, participants will crossover to the opposite intervention from their first visit. The primary outcomes are the difference in self-reported pain and anxiety between the two interventions. Feasibility outcomes include the proportion of screened patients who are eligible, consent, and complete both visits and adverse events reported. To evaluate the efficacy of pain reduction, composite scores of pain score, pain medication will be calculated for each laser visit. To evaluate the efficacy of anxiety reduction, the change of mYPAS scores will be compared between control and VR groups at each visit using Wilcoxon rank sum tests. All statistical analyses will follow the intention-to-treat principle in regard to intervention assignment at each visit. ResultsThe study was funded in January 2023 and began enrollment at that time. A total of n=44 participants were recruited and data collection was completed in November 2025, with n=40 subjects completing both visits. The sample was balanced with n=40 subjects using the intervention and participating in the control condition. The age range of the complete sample was 6 to 21 years at recruitment and was 55% female sex. Data analysis is in progress with final results planned for June 2026. ConclusionsFindings from this innovative randomized clinical trial will provide early evidence on the efficacy of the VR-PAT for reducing self-reported pain and anxiety during outpatient laser procedures. The results from this trial will inform a large-scale, multisite study. Trial RegistrationClinicalTrials.gov: NCT05645224 [https://clinicaltrials.gov/study/NCT05645224]

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Exploring provider preferences in the design of HIV treatment packages integrating long-acting injectable antiretroviral therapy in New York Ryan White Part A medical case management programs

Zimba, R.; Kelvin, E. A.; Kulkarni, S.; Carmona, J.; Avoundjian, T.; Emmert, C.; Peterson, M.; Irvine, M.; Nash, D.

2026-04-23 hiv aids 10.64898/2026.04.22.26351494 medRxiv
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Introduction Understanding provider preferences for the design of HIV treatment packages could enhance the implementation of programs to support the adoption of long-acting injectable antiretroviral therapy (LAI ART) by people living with HIV who are interested in initiating this treatment modality. Methods We recruited providers from New York City (NYC), Rockland, Putman, and Westchester County Ryan White Part A Medical Case Management (MCM) programs to complete a discrete choice experiment (DCE) containing twelve tasks with two alternatives and an opt-out option, with additional survey questions about implementation readiness and choice motivations. The alternatives included four attributes--Type of ART Medication (monthly or bimonthly LAI ART), Service Location and Mode, Support for Clients, and Rewards for Clients--with 2-4 levels each. We ran latent class multinomial logit analyses (LCA) with 1-5 classes to estimate preferences and explore hypothesis-free preference heterogeneity. We estimated attribute influence using relative importances and preferences using zero-centered part-worth utilities for each level. Results One hundred seventy-seven providers completed the survey (July 2022-January 2023). About half (52%) were 40-59 years old, 72% identified as women, and the plurality (41%) identified as Latino/a. We chose the two-group LCA solution. Bimonthly LAI ART was preferred over monthly LAI ART overall and in both groups. Group 1 (n=45) preferred more traditional adherence supports (e.g., injections at the clinic by appointment, injection appointment reminders) whereas Group 2 (n=132) preferred more client-centered supports (e.g., injections at home by appointment, free transportation to injection appointments if at a clinic). Both groups preferred higher monetary value gift cards for clients for every on-time injection. The top-ranking motivations indicated that participants prioritized patient convenience over job satisfaction and administrative or financial feasibility for the agency. The scores for all implementation measures indicate readiness to implement LAI ART in both groups. Conclusions Our implementation science-focused study suggests that providers of MCM services in NYC and surrounding counties are motivated to offer services to support clients' access and adherence to LAI ART. More work is needed to understand how programs have, in fact, integrated supports for LAI ART into their services.

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"Isn't social prescribing what social workers have been doing forever"?: UK social worker perspectives on social prescribing and professional boundaries

White, C.; Price, E.; Walker, L.; Bell, J.; Revell, L.

2026-04-27 primary care research 10.64898/2026.04.24.26351583 medRxiv
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Social prescribing has assumed increasing dominance in policy and practice internationally, including in the UK, where it has an increasing role in addressing social needs such as isolation, and social determinants of ill health. Although General Practitioners are perceived as key referral sources, social workers in one locality were found to play a significant role in referral. This suggests that the social work role in this context has been under recognised and under explored. This study sought to explore social workers' perceptions and experiences of social prescribing through an online survey conducted from January to June 2022. All UK social workers were eligible to participate, regardless of whether they had made referrals. A total of 105 responses were collected from all UK nations. Data was analysed using inductive thematic analysis. Four key themes were generated: contended and contested boundaries; complementary spaces; delineated spaces of simplicity and complexity; social work under threat. Participants recognised that social prescribing could provide valuable client support and could be a useful resource for social workers. However, they also expressed concerns about overlapping professional boundaries and the potential for social prescribing to encroach on social work, perceiving it as most appropriate for the delivery of support to those with 'low level' needs.

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Therapist effects in real-world rehabilitation outcomes: a cohort study of the nationwide GLA:D osteoarthritis management program in Denmark

Obasohan, P. E.; Palmer, J.; Alderson, D.; Yu, D.; Gronne, D. T.; Roos, E. M.; Skou, S. T.; Peat, G. M.

2026-04-21 rehabilitation medicine and physical therapy 10.64898/2026.04.20.26351120 medRxiv
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ObjectiveUnlike several other fields of healthcare, little is known about the size of therapist effects on patient outcomes following rehabilitation for musculoskeletal conditions. We aimed to estimate the proportion of variance in patient outcomes from a structured rehabilitation program explained by therapist effects. MethodsFor our observational cohort study we accessed data from the national multicentre Good Life with osteoArthritis in Denmark (GLA:D) osteoarthritis management program. Analyses included 23,021 consecutive eligible adults with hip or knee osteoarthritis (mean (SD) age 65.0 (9.8) years, 71% female) treated by 657 therapists between October 2014 and February 2019. The primary outcome was [≥]30% reduction in pain intensity on 0-100 VAS at 3 months. Therapist effects were estimated as the variance partition coefficient (intra-class correlation coefficient (ICC)) from two-level random intercept logistic regression models before and after adjusting for patient-level case-mix factors and therapist-level characteristics (number of patients treated, days since therapist certification). Analyses were repeated for a range of secondary outcomes using multiply imputed data and complete-case analysis. Results52% of patients reported a [≥]30% reduction in pain intensity on 0-100 VAS at 3 months. In the null model the ICC was 0.007 (95%CI: 0.005, 0.009), which changed little after adjusting for patient- and therapist-level covariates. Upper confidence limits for ICC estimates across all secondary outcomes in multiply imputed and complete case analyses were less than 0.03. ConclusionsIn a nationally implemented osteoarthritis management program delivered by trained healthcare professionals, therapist effects made a minimal contribution to variation in patient outcomes. KEY MESSAGESO_ST_ABSWhat is already known on this topicC_ST_ABS Therapist effects - defined as the effect of a given therapist on patient outcomes as compared to another therapist - have been observed in several fields of healthcare and have important consequences for selection, training, and service improvement. In musculoskeletal rehabilitation five previous studies suggest that 1-12% of variation in patient-reported outcomes may be attributable to therapist effects, but these estimates were based on relatively small datasets resulting in substantial uncertainty. What this study addsOur cohort study analysed registry data from 2014-2019 on 23,021 patients and 647 trained therapists from the nationally implemented GLA:D structured osteoarthritis management program in Denmark. We found that therapist effects accounted for less than 3% of total variation in patient-reported pain and quality of life outcomes 3 months after beginning the program How this study might affect research, practice, or policyOur findings suggest that contextual factors that relate to therapist effects - therapist characteristics or therapist-patient interaction and alliance - make a minimal contribution to variation in patient outcomes from this structured, group-based rehabilitation intervention. Any contextual effects must be attributable to alternative sources, e.g. patient expectations, intervention setting.

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Development and Evaluation of iSupport-Malaysia: A Multimedia Web-Based Psychoeducational Intervention for Dementia Caregivers

Loh, K. J.; Lee, W. L.; Ng, A. L. O.; Chung, F. F. L.; Renganathan, E.

2026-04-21 geriatric medicine 10.64898/2026.04.14.26350743 medRxiv
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BackgroundCaring for people with dementia can impose a considerable psychological burden on caregivers, yet access to caregiver support in Malaysia remains limited. The World Health Organizations iSupport for Dementia program provides dementia education via textual, e-learning format. However, a culturally adapted Malaysian version has not been available. ObjectiveThis study aimed to develop and gather user feedback on a culturally adapted, multimedia version of iSupport tailored for Malaysia (iSupport-Malaysia). MethodsGuided by a four-phase cultural adaptation framework, the generic iSupport content was translated into Bahasa Malaysia, adapted to local customs, and transformed into multimedia lessons on an e-learning platform. A mixed-methods design was used to explore user perceptions and evaluate usability through four homogeneous focus group discussions and 15 individual usability test sessions with informal caregivers (FG: n=9; UT: n=9) and healthcare professionals (FG: n=11; UT: n=6). Focus groups examined aesthetics, ease of use, clarity, cultural relevance, comprehensiveness, and satisfaction. Usability testing involved Think Aloud tasks, post-test questionnaires, and brief interviews. Qualitative data was analysed thematically, and descriptive statistics summarised usability performance. ResultsiSupport-Malaysia demonstrated good usability (M=74.3{+/-}18.0), with most tasks completed without assistance. Strengths included interactive learning activities, peer discussion features, and flexible self-paced learning. Content was viewed as culturally appropriate, credible, and useful. Suggested improvements included enhancing visual aesthetics, shortening videos, refining quizzes, and increasing practical relevance. ConclusionUser insights indicate that iSupport-Malaysia is usable and culturally appropriate. These findings will inform refinement of the platform prior to the pilot feasibility study and provide recommendations for future multimedia-based caregiver interventions.

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Knowledge, Awareness, and Prescribing Practices Regarding Sugar-Free Paediatric Liquid Medicines Among Healthcare Professionals in Uttarakhand: A Cross-Sectional Study

Jha, K.; Chaudhry, K. K.; Khanduri, N.

2026-04-22 primary care research 10.64898/2026.04.15.26350902 medRxiv
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BackgroundPaediatric liquid medicines (PLMs) routinely contain sucrose to improve palatability, yet their cariogenic potential is well established. Healthcare professionals awareness and prescribing practices regarding sugar-free PLMs have received limited study in India, particularly in Uttarakhand. MethodsA descriptive cross-sectional study was conducted among 500 healthcare professionals aged [&ge;]25 years, using a pilot-tested structured questionnaire (Cronbachs = 0.85), administered online and in person across Uttarakhand districts (January-March 2024). After excluding 69 incomplete responses, 431 participants were analysed (response rate: 86.2%), comprising general medicine practitioners (49%, n = 211), paediatricians (27%, n = 116), and dental practitioners (24%, n = 104). Descriptive statistics and chi-square tests were applied (p < 0.05). ResultsPrescription decisions were primarily driven by childs age and weight (58%), cost (40%), and pharmaceutical brand (37%). While 88% recognised PLM sweetness and 67% were aware of pH-dental harm links, only 20% associated PLMs with dental caries. Overall awareness of hidden sugars was 73%. Eighty-three percent knew of sugar-free alternatives (50% local availability), yet 80% found them less palatable and 85% costlier. Only 48% routinely provided oral health advice. A statistically significant association was found between specialty and sugar-free PLM awareness (p = 0.03), with dental practitioners recording the highest awareness (90%). ConclusionsHealthcare professionals demonstrated variable levels of knowledge, attitudes, and practices regarding PLMs, with critical gaps in caries recognition (20%) and oral health counselling (48%). Despite high sugar-free PLM awareness, uptake is constrained by perceived cost and palatability barriers. Targeted continuing medical education and policy measures, including sucrose-free labelling promotion, are needed to improve paediatric oral health outcomes in Uttarakhand. KEY MESSAGESO_LIOnly 20% of healthcare professionals in Uttarakhand associated pediatric liquid medicines (PLMs) with dental caries, representing a critical knowledge gap despite 88% recognising their sweetness. C_LIO_LIOverall awareness of hidden sugars in PLMs was 73%, yet only 48% routinely provided post-prescription oral health counsellingsubstantially below international benchmarks. C_LIO_LIEighty-three percent were aware of sugar-free PLM alternatives, but adoption was constrained by perceived inferior palatability (80%) and higher cost ([~]10% premium, cited by 85%). C_LIO_LIDental practitioners demonstrated significantly higher sugar-free PLM awareness than general practitioners and pediatricians (p = 0.03), supporting the case for interprofessional oral health education in medical training. C_LIO_LITargeted continuing medical education (CME) and policy measuresincluding sucrose-free labelling mandates and institutional formulary inclusionare needed to convert awareness into prescribing practice change. C_LI

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Assessing the efficacy of behaviourally informed invitation messaging in increasing attendance at the NHS Targeted Lung Health Check: A randomised experimental study

Tan, X.; Danka, M. N.; Urbanski, S.; Kitsawat, P.; McElvaney, T. J.; Jundi, S.; Porter, L.; Gericke, C.

2026-04-24 public and global health 10.64898/2026.04.12.26350693 medRxiv
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Background: Lung cancer screening can reduce lung cancer mortality through early detection, but uptake of the NHS Targeted Lung Health Check (TLHC) programme remains low. Behaviourally informed invitation messages have been proposed as a low-cost approach to increase attendance, but evidence of their effectiveness in lung cancer screening is mixed. Few intervention studies used evidence-based behaviour change frameworks, and rarely tailored invitation strategies to empirically identified barriers and enablers. Methods: In an online experiment, 3,274 adults aged 55-74 years and with a history of smoking were randomised to see one of four behaviourally informed invitation messages or a control message. Participants then rated their intention to attend a TLHC appointment, and selected barriers and enablers to attending from a pre-defined list, which were classified according to the Theoretical Domains Framework. Invitation messages were mapped to Behaviour Change Techniques using the Theory and Techniques Tool. Message conditions were compared on intention to attend TLHC using bootstrapped ANOVA followed by pairwise comparisons. Exploratory counterfactual mediation analyses examined the role of fear in intention to attend. Results: Behaviourally informed invitation messages did not meaningfully increase intention to attend TLHC compared with the control message. While a GP-endorsed message showed a small potential benefit relative to the other conditions, this finding was not robust after adjustment for multiple comparisons. Participants most frequently reported barriers related to Emotion (particularly fear), Social Influence, and Knowledge, while Beliefs about Consequences emerged as the primary enabler of attendance. Only around half of reported barriers and enablers were addressed by the invitation messages. Exploratory analyses found that fear was associated with lower intention to attend a TLHC appointment, yet none of the behaviourally informed messages appeared to reduce fear compared to the control message. Conclusions: Improving lung cancer screening uptake will likely require invitation messages that directly address emotional concerns, particularly fear, alongside credible recommendations. These findings highlight the importance of systematically aligning invitation message content with empirically identified behavioural influences when designing scalable interventions to improve lung cancer screening uptake.

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BRIDGE: a barrier-informed Bayesian Risk prediction model for risk IDentification, trajectory Grouping, and profiling of non-adherencE to cardioprotective medicines in primary care

Koh, H. J. W.; Trin, C.; Ademi, Z.; Zomer, E.; Berkovic, D.; Cataldo Miranda, P.; Gibson, B.; Bell, J. S.; Ilomaki, J.; Liew, D.; Reid, C.; Lybrand, S.; Gasevic, D.; Earnest, A.; Gasevic, D.; Talic, S.

2026-04-22 pharmacology and therapeutics 10.64898/2026.04.21.26351387 medRxiv
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BackgroundNon-adherence to lipid-lowering therapy (LLT) affects up to half of patients and contributes substantially to preventable cardiovascular morbidity and mortality. Existing measures, such as the proportion of days covered, provide cross-sectional summaries but fail to capture the dynamic patterns of adherence over time. Although group-based trajectory modelling identifies distinct longitudinal adherence patterns, no approach currently predicts trajectory membership prospectively while incorporating patient-reported barriers. We developed BRIDGE, a barrier-informed Bayesian model to predict adherence trajectories and identify their underlying drivers. MethodsBRIDGE incorporates patient-reported barriers as structured prior information within a Bayesian framework for adherence-trajectory prediction. The model was designed not only to estimate which patients are likely to follow different adherence trajectories, but also to generate clinically interpretable probability estimates that help explain why those trajectories may arise and what modifiable factors may be most relevant for intervention. ResultsBRIDGE achieved a macro AUROC of 0.809 (95% CI 0.806 to 0.813), comparable to random forest (0.815 (95% CI 0.812 to 0.819)) and XGBoost (0.821 (95% CI 0.818 to 0.824)), two widely used machine-learning benchmarks for structured clinical prediction. Calibration was superior to random forest (Brier score 0.530 vs 0.545; ), and performance was stable across six independent training runs (AUROC SD = 0.003). Incorporating barrier-informed priors improved accuracy by 3.5% and calibration by 5.5% compared to flat priors, showing that incorporation of patient-reported barriers added value beyond electronic medical record data alone. Four clinically distinct adherence trajectories were identified: gradual decline associated with treatment deprioritisation amid polypharmacy (10.4%), early discontinuation linked to asymptomatic risk dismissal (40.5%), rapid decline associated with intolerance (28.8%), and persistent adherence (20.2%). Counterfactual analysis identified trajectory-specific intervention levers. ConclusionsBRIDGE provides accurate and well-calibrated prediction of adherence trajectories while offering clinically actionable insights into their underlying drivers. By integrating patient-reported barriers with routine clinical data, the model supports targeted, mechanism-informed interventions at the point of prescribing to improve adherence to cardioprotective therapies. FundingMRFF CVD Mission Grant 2017451 Evidence before this studyWe searched PubMed and Scopus from database inception to December 2025 using the terms "medication adherence", "trajectory", "prediction model", "Bayesian", "lipid-lowering therapy", and "barriers", with no language restrictions. Group-based trajectory modelling has consistently identified three to five adherence patterns across cardiovascular cohorts; however, these applications have been descriptive rather than predictive. Machine-learning models for adherence prediction achieve moderate discrimination but treat adherence as a binary or continuous outcome, thereby overlooking the clinically meaningful heterogeneity captured by trajectory approaches. One prior study applied a Bayesian dynamic linear model to examine adherence-outcome associations, but it did not predict adherence trajectories or incorporate patient-reported barriers. To our knowledge, no published model integrates patient-reported barriers into trajectory prediction. Added value of this studyBRIDGE is, to our knowledge, the first model to incorporate patient-reported adherence barriers as hierarchical domain-informed priors within a Bayesian framework for trajectory prediction. Using 108 predictors derived from routine electronic medical records, the model achieves discrimination comparable to state-of-the-art machine-learning approaches while additionally providing uncertainty quantification, barrier-level interpretability, and counterfactual insights to inform intervention strategies. The identified trajectories differed not only in adherence level but also in switching behaviour, drug-class evolution, and medication burden, suggesting distinct underlying mechanisms of non-adherence that may require tailored clinical responses. Implications of all the available evidenceEach adherence trajectory implies a distinct intervention target: asymptomatic risk communication for early discontinuers (40.5% of patients), proactive tolerability management for rapid decliners, medication simplification for patients with gradual decline associated with polypharmacy, and maintenance support for persistent adherers. By integrating routinely collected clinical data with patient-reported barriers, BRIDGE can be deployed within existing primary care EMR infrastructure to generate actionable, trajectory and patient--specific recommendations at the point of prescribing, helping to bridge the gap between adherence measurement and targeted adherence management.

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Pharmacist Led Nutritional Counselling as a Community Intervention for Obesity, Undernutrition, and Anaemia: Evidence from a 1135 Participant Prospective Interventional Study in India

Duddu, R.

2026-04-27 public and global health 10.64898/2026.04.25.26351725 medRxiv
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Objectives: To examine the pattern, magnitude, and demographic distribution of measurable improvements across five outcome parameters following three monthly pharmacist-led nutritional counselling sessions delivered to community-dwelling participants in semi-urban India. Design: Secondary analysis of interventional follow-up data from a prospective community-based study. Setting: Schools and colleges in Narasaraopeta, Andhra Pradesh, India, from September 2021 to March 2022. Participants: Of 1,200 participants assessed at baseline, 1,135 (94.6%) completed at least one counselling session and formed the analysis cohort. The age range was 10 to 60 years. The majority of participants, 92.4%, were aged between 11 and 20 years. All 1,135 were anaemic at baseline. Interventions: Three structured monthly counselling sessions were delivered by pharmacy students under qualified faculty pharmacist supervision. Each session included individualised dietary guidance, lifestyle modification advice, and culturally adapted written health education materials. Primary and secondary outcome measures: Cumulative proportion of participants achieving measurable improvement in body mass index (BMI), waist circumference (WC), hip circumference (HC), waist to hip ratio (WHR), and haemoglobin (Hb) concentration at each session, stratified by age group and sex. Results: All five parameters showed progressive cumulative improvement across sessions. By session three, 44 participants (3.6%) showed improved BMI, 39 (3.25%) achieved reduced WC, 34 (2.8%) reduced HC, 33 (2.75%) improved WHR, and 115 (9.5%) demonstrated improved Hb. Adolescents aged 11 to 20 years were consistently the most responsive subgroup. Haemoglobin showed the steepest improvement trajectory, rising from 1.75% at session one to 9.5% at session three, representing a 5.4 fold increase achieved through dietary counselling alone without pharmacological supplementation. Conclusions: Three monthly pharmacist led nutritional counselling sessions produce measurable and progressive improvements in both anthropometric and haematological outcomes in community settings. Adolescents are the most responsive population. These findings support the integration of pharmacists into community non communicable disease prevention programmes in India and provide a replicable low resource model applicable to comparable global settings.

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Improving Care by FAster risk-STratification through use of high sensitivity point-of-care troponin in patients presenting with possible acute coronary syndrome in the EmeRgency department (ICare-FASTER): a stepped-wedge cluster randomized trial

Than, M.; Pickering, J. W.; Joyce, L. R.; Buchan, V. A.; Florkowski, C. M.; Mills, N. L.; Hamill, L.; Prystowsky, J.; Harger, S.; Reed, M.; Bayless, J.; Feberwee, A.; Attenburrow, T.; Norman, T.; Welfare, O.; Heiden, T.; Kavsak, P.; Jaffe, A. S.; apple, f.; Peacock, W. F.; Cullen, L.; Aldous, S.; Richards, A. M.; Lacey, C.; Troughton, R.; Frampton, C.; Body, R.; Mueller, C.; Lord, S. J.; George, P. M.; Devlin, G.

2026-04-23 cardiovascular medicine 10.64898/2026.04.21.26351433 medRxiv
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BACKGROUND Point-of-care (POC) high-sensitivity cardiac troponin (hs-cTn) testing has the potential to expedite decision-making and reduce emergency department (ED) length of stay for patients presenting with possible myocardial infarction (MI) by ensuring that results are consistently available when looked for by clinicians. We assessed the real-life effectiveness and safety of implementing POC hs-cTn testing in the ED. METHODS We conducted a pragmatic, stepped-wedge cluster randomized trial. The control arm was usual care with an accelerated diagnostic pathway utilizing a single-sample rule-out step with a central laboratory hs-cTn assay. The intervention arm used the same pathway with a POC hs-cTnI. The primary effectiveness outcome was ED length of stay assessed using a generalized linear mixed model, and the safety outcome was 30-day MI or cardiac death. RESULTS Six sites participated with 59,980 ED presentations (44,747 individuals, 61{+/-}19 years, 49.5% female) from February 2023 to January 2025, in which 31,392 presentations were during the intervention arm. After adjustment for co-variates associated with length of stay, the intervention reduced length of stay by 13% (95% confidence intervals [CI], 9 to 16%. P<0.001), corresponding to a reduction of 47 minutes (95%CI, 33 to 61 minutes) from a mean length of stay in the control arm of 376 minutes. The 30-day MI or cardiac death rate was similar in the control and intervention arms (0.39% and 0.39% respectively, P=0.54). CONCLUSIONS Implementation of whole-blood hs-cTnI testing at the POC into an accelerated diagnostic pathway was safe and reduced length of stay in the ED compared with laboratory testing.

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The Acceptability and Impact of the Community-Based Blood Pressure Group pilot intervention in Zimbabwe.

Mhino, F. M.; Ndanga, A.; Chivandire, T.; Sekanevana, C.; Mpandaguta, C. E.; Mwanza, T.; Mutengerere, A.; Scott, S.; Chimberengwa, P.; Dixon, J.; Ndhlovu, C. E.; Seeley, J.; Chingono, R. M. S.; Sabapathy, K.

2026-04-22 public and global health 10.64898/2026.04.20.26351307 medRxiv
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IntroductionOver one billion people worldwide have hypertension. In Zimbabwe, prevalence is an estimated 38%, surpassing the global average of 34%, and >50% of hypertensives are undiagnosed. The Community BP groups (Com-BP) study examined whether community groups of people living with hypertension, provided with BP machines and led by trained Facilitators could improve awareness, screening and support for those diagnosed with hypertension, to help blood pressure (BP) control. We present findings from the quantitative evaluation of the Com-BP pilot intervention. MethodsThe acceptability of the Com-BP intervention, its potential effectiveness in improving knowledge, attitudes and practices (KAP) and in reducing BP among hypertensive adults in Zimbabwe, was evaluated. Cross-sectional surveys using standardised questionnaires, and BP and Body Mass Index (BMI) assessments, were done at the start and end of the pilot intervention. Statistical evidence of difference between baseline and follow-up was examined using Wilcoxon signed-rank test for continuous data and McNemars test for categorical data. ResultsFourteen groups (seven urban and seven rural) were formed and 151 participants joined over a median of 5months. Retention in the groups was 97.9% (137/140 recruited at baseline), with approximately equal numbers from the urban and rural sites. Median age at baseline was 54 years (IQR 45-66y; min-max 30-92y) and the majority (79%, n=108) were female. Most participants (82.5%, n=113) rated their experience of the group sessions as excellent. The proportions of participants with changes in KAP from baseline to endline were as follows: 45.3% (n=62) to 81.0% (n=111) (p=0.004) able to identify at least two pre-disposing factors for hypertension; 65.0% (n=89) to 77.4% (n=106) (p=0.02) reporting [&ge;]1day of vigorous physical activity/week; 28.5% (n=39) to 13.9% (n=19) (p=0.001) reporting salt added to meals at the table. There was no statistical evidence of any difference in medication adherence, p=0.06. The proportion of participants with uncontrolled hypertension was 58.1% (n=79) at baseline and reduced to 31.8% (n=43) at follow-up (p<0.001). DiscussionCommunity groups for improving awareness, detection and support are acceptable and led to improvements in self-reported KAP and prevalence of uncontrolled BP. Further research on the sustainability and impact of the intervention is required.

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Group A Streptococcus Molecular Point of Care testing in a Paediatric Emergency Department

Mills, E. A.; Bingham, R.; Nijman, R. G.; Sriskandan, S.

2026-04-22 infectious diseases 10.64898/2026.04.20.26351279 medRxiv
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BackgroundAn upsurge in Streptococcus pyogenes infections 2022-2023 highlighted potential benefits of point-of-care tests (POCT) to support clinical pathways, prevent outbreaks, and optimise antibiotic use. ObjectivesWe conducted a pilot research study in a west London paediatric emergency department (ED) to determine whether a molecular POCT had potential to alter management in children who were also having a conventional throat swab taken for culture. MethodsChildren <16 years presenting to ED who had a throat swab requested by a clinician were invited to have a second swab taken for research purposes only. Clinical management was unaffected by the research swab result, which was processed using a molecular POCT that was not approved for use in the host NHS Trust. ResultsPrevalence of streptococcal infection was low during the study (May 2023-June 2025); swab positivity in symptomatic children was 12.8% (6/47). Overall, 38/49 (77.6%) participants who had throat swabs received antibiotics. Of those children recommended to receive antibiotics, 29/38 (76.3%) had a negative POCT. Mean time to reporting of positive throat swab culture results was 3.67 days (range 3-5 days) leading to occasional delay in treatment, although POCT identified positive results within minutes. ConclusionAntibiotic use was frequent and could be avoided or stopped by use of a rule out POCT in over three-quarters of children in the ED, if suspicion of S. pyogenes is the main driver for prescribing. POCT were easy to process and produced immediate results compared with culture, in theory enabling timely decision-making and avoiding treatment delay.

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Patient perspectives on living with hypertension: Social media listening analysis across predominantly high-income countries

Di Somma, S.; Gervais, R.; Bains, M.; Carter-Williams, S.; Messner, S.; Onsongo, N.

2026-04-23 cardiovascular medicine 10.64898/2026.04.22.26351483 medRxiv
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Background: Chronic conditions such as hypertension can significantly disrupt daily life and emotional wellbeing. The interaction between patients' perceptions, adherence to antihypertensive medication and quality of life (QoL) remains underexplored outside structured clinical settings. Objectives: To capture unprompted patient perspectives and assess whether hypertension affects QoL and to investigate if patient reported experiences are associated with self-reported antihypertensive medication adherence. Methods: Social media listening (SML) study analyzing 86,368 anonymized posts from individuals with hypertension in 12 countries, collected between January 2022 and May 2024. Posts from 11 countries (n=81,368) were analyzed using artificial intelligence-enabled natural language processing. Posts from China (n=5,000) were analyzed separately using a harmonized framework. Quantitative and qualitative methods assessed variations by country, age, and gender, and associations between emotional expression and antihypertensive medication adherence. Results: Across the 11-country core sample, 45% of posts mentioned at least one QoL impact, most commonly worry/anxiety (11%). Impacts varied across countries. Among 8,096 posts with age identified, individuals <40 years reported emotional balance impacts in 28% of posts versus 22% among those aged 40+. Work/Education impacts were mentioned in 17% of posts by those <40 years vs 12% in 40+. Among 7968 posts explicitly referencing adherence, expressed worry was associated with stricter adherence (62% association score), as were structured routines (79% score), home monitoring (77%), dietary changes (77%), and exercise (71%). In contrast, sadness/depression was associated with inconsistent adherence (71%), as were forgetfulness (79%), side effects (73%), and cost/insurance concerns (65%). Conclusions: These results emphasize the importance of the psychological and emotional impact of hypertension, including on adherence to medication regimens, reinforcing the value of a holistic approach to patient care.

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Missed Opportunities for Stroke Prevention in Hypertensive Patients: A Retrospective Case-Control Study

Yang, H.; Liu, Y.; Kim, C.; Huang, C.; Sawano, M.; Young, P.; McPadden, J.; Anderson, M.; Burrows, J. S.; Krumholz, H. M.; Brush, J. E.; Lu, Y.

2026-04-22 cardiovascular medicine 10.64898/2026.04.21.26351407 medRxiv
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BackgroundHypertension is the leading modifiable risk factor for ischemic stroke, yet the adequacy of preventative hypertension care in routine clinical practice remains suboptimal. Whether gaps in hypertension management represent missed opportunities for stroke prevention remains unclear. ObjectiveTo evaluate the association between hypertension care delivery and the risk of incident ischemic stroke. MethodsWe conducted a retrospective, matched, nested case-control study among adults with hypertension using electronic health record data from a large regional health system (2010-2024). Patients with a first-ever ischemic stroke were matched 1:2 to controls on age, sex, race and ethnicity, and calendar time. Three care metrics were assessed during follow-up: (1) outpatient visits with blood pressure (BP) measurement per year; (2) number of antihypertensive medication ingredients; and (3) medication intensification score. Conditional logistic regression estimated adjusted odds ratios (aORs). ResultsThe study included 13,476 cases and 26,952 matched controls (N = 40,428). Mean (SD) age was 64.8 (12.2) years, 54.1% were female, and mean follow-up was 2,497 (1,308) days. Cases had fewer BP visits per year (median, 2.50 vs. 3.01; p < 0.001), similar number of medication ingredients (2.00 vs 2.00), and lower treatment intensification scores (-0.211 vs - 0.125). In adjusted models, >5 BP visits per year was associated with lower stroke odds (aOR, 0.55; 95% CI, 0.51-0.59) compared with [&le;]1 visit. Use of 2-3 medication ingredients (vs 0) was also associated with reduced stroke odds (aOR, 0.80; 95% CI, 0.75-0.86), whereas >3 ingredients was not significant. The highest quartile of treatment intensification showed the strongest association (aOR, 0.47; 95% CI, 0.44-0.51). Findings were consistent across subgroup and sensitivity analyses, including strata defined by baseline SBP and follow-up SBP. ConclusionsGreater engagement in hypertension care was associated with lower odds of ischemic stroke, suggesting that gaps in routine management may represent missed opportunities for prevention.

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International Adaptation of a brief Problem-Solving Skills (the IAPPS trial) training for people in custody with severe mental illness in Poland: an open multicentred, parallel group, feasibility randomised controlled trial.

Perry, A. E.; Zawadzka, M.; Rychlik, J.; Hewitt, C.

2026-04-25 forensic medicine 10.64898/2026.04.24.26351654 medRxiv
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Objectives: The primary aim of this study was to assess the feasibility of delivering an adapted problem-solving skills (PSS) intervention by quantifying the recruitment, follow-up and completion rates using a brief problem-solving intervention for people with a mental health diagnosis in two Polish prisons. Design: IAPPS is an open, multi-centred, parallel group feasibility randomised controlled trial (RCT). Setting: Two prisons in Poland. Participants: Men in custody aged 18 years and older, having a mental illness and living within the prison therapeutic unit. Interventions: The intervention consisted of an adapted PSS skills intervention plus care as usual (CAU) or care as usual only. Delivered in groups of up to five people in 1.5-hour sessions over the course of two weeks. Main outcome measures: Primary outcomes - rate of recruitment, follow-up, and feasibility to deliver the intervention. Secondary outcomes included measures of depression, general mental health, and coping strategies. Results: 129 male prisoners were screened, 64 were randomly allocated, with a mean age of 53.5 years (SD 14, range 23-84). 59 (95%) prisoners were of Polish origin. Our recruitment rate was 48%. There was differential follow up with those in the intervention group less likely to complete the post-test battery versus those who received care as usual. Outcome measures were successfully collected at both time points. Conclusions We were able to recruit, retain and deliver the intervention within the prison setting; some logistical challenges limited our assessment of intervention engagement. Our data helps to demonstrate how use of the RCT study design can be implemented and delivered within the complex prison environment. Trial registration number ISRCTN 70138247, protocol registration date May 2021

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A rights-based intervention integrating social work and ophthalmic care for people experiencing or at risk of homelessness

Hassani, A.; Pecar, K.; Soliman, M.; Bunyon, P.; Ellinger, C.; Tulysewskid, G.; Croft, J.; Carillo, C.; Wewegama, G.; du Plessis-Schneider, S.; Estevez, J. J.

2026-04-24 public and global health 10.64898/2026.04.22.26351525 medRxiv
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Background Individuals experiencing or at risk of homelessness face substantial barriers to preventive eye care that are poorly addressed by standard service models. Interdisciplinary optometry-social work collaboration offers a rights-based approach to improving engagement and continuity of care. Methods A convergent mixed-methods study was conducted between February and August 2024 at a multidisciplinary community centre. Clients experiencing or at risk of homelessness received integrated optometry and social work assessment and were prioritised as high, medium, or low based on combined clinical and social risk. Social work follow-up was guided by the Triple Mandate and W-Questions framework. Quantitative data were summarised using mean (SD), median [IQR], or n (%). Qualitative case notes were analysed using content analysis with inductive coding and secondary review for consistency. Results A total of 165 clients had priority categories coded (high: 68; medium: 47; low: 154). Demographic data were available for 132 clients (60% male; mean age 49.5 years [SD 16]); 27% had not completed high school, 89% reported weekly income below AUD 1000, and 28% had vision impairment. Two hundred forty-five case-note entries were consolidated into 146 unique records. SMS (46%) and phone calls (38%) were the most documented contact methods, although only 21% of calls were answered; missed calls (13%) and disconnected numbers (7%) were common. Multi-modal contact was more frequently documented for higher-priority clients. Appointment assistance was the most recorded facilitator (71%), while rights-based supports, including interpreter and transport assistance, were infrequently documented (<=5%). Qualitative analysis identified unstable communication, reliance on informal supports, and service fragmentation as key influences on recall outcomes. Conclusion This study supports an interdisciplinary, rights-based optometry-social work model to address barriers to preventive eye care among people experiencing or at risk of homelessness. Embedding structured handovers and tiered recall processes within community-based services may strengthen continuity and accountability for high-priority clients. Future implementation should evaluate outcomes related to equity of reach, service integration, and sustained engagement in care.

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Design and preliminary safety validation of a hybrid deterministic-AI triage system for multilingual primary healthcare: a WhatsApp-based vignette study in South Africa

Nkosi-Mjadu, B. E.

2026-04-22 health informatics 10.64898/2026.04.21.26349781 medRxiv
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BackgroundSouth Africas public healthcare system serves most of the population through approximately 3,900 primary healthcare clinics characterised by long waiting times and high volumes of repeat-prescription visits. No published pre-arrival digital triage system operates across all 11 official South African languages while aligning with the South African Triage Scale (SATS). This paper reports the design and preliminary safety validation of BIZUSIZO, a hybrid deterministic-AI WhatsApp triage system. MethodsBIZUSIZO delivers SATS-aligned triage via WhatsApp, combining AI-assisted free-text classification (Claude Haiku 4.5) with a Deterministic Clinical Safety Layer (DCSL) that overrides AI output for 53 clinical discriminator categories (14 RED, 19 ORANGE, 20 YELLOW) coded in all 11 official languages and independent of AI availability. A five-domain risk factor assessment can only upgrade triage level. One hundred and twenty clinical vignettes in patient language (English, isiZulu, isiXhosa, Afrikaans; 30 per language) were scored against a developer-assigned gold standard with independent blinded nurse review. A 121-vignette multilingual DCSL safety consistency check across all 11 languages and a 220-call post-hoc framing sensitivity evaluation (110 paired vignettes) were also conducted. ResultsUnder-triage was 3.3% (4/120; 95% CI: 0.9%-8.3%) with no RED under-triage; exact concordance was 80.0% (96/120) and quadratic weighted kappa 0.891 (95% CI: 0.827-0.932). One two-level under-triage was observed on a non-RED presentation (V072, isiXhosa burns vignette, ORANGEGREEN); one two-level over-triage was observed (V054, isiZulu deep laceration, YELLOWRED). In the framing sensitivity evaluation, AI-only classification achieved 50.9% RED invariance under adversarial framing; full-pipeline classification achieved 95.0% in four validated languages, with the DCSL rescuing 18 of 23 AI drift cases. ConclusionsA hybrid deterministic-AI triage system with DCSL-based emergency detection achieved zero RED under-triage and consistent RED detection across all 11 official languages. The 16.7% over-triage rate falls within published South African SATS ranges (13.1-49%). A single two-level under-triage event was observed on an isiXhosa burns vignette (ORANGEGREEN) and is discussed in Limitations. Findings are preliminary; prospective validation against independent nurse triage is the necessary next step.

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A Return-on-Investment Analysis of a Community-Based Diabetes Self-Management Program In New York City

Goldwater, J. C.; Harris, Y.; Das, S. K.; Fernandez Galvis, M. A.; Maru, D.; Jordan, W. B.; Sacaridiz, C.; Norwood, C.; Kim, S. S.; Neustrom, K.

2026-04-23 health economics 10.64898/2026.04.22.26351481 medRxiv
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OBJECTIVE: To evaluate the return on investment (ROI) of a community based Diabetes Self Management Program (DSMP) enhanced with health related social needs (HRSN) screening and referrals, implemented by the New York City (NYC) Department of Health and Mental Hygiene with three community based organizations in highly impacted, under resourced neighborhoods. RESEARCH DESIGN AND METHODS: A retrospective cost benefit analysis from a public sector payer perspective was conducted among 171 adults with type 2 diabetes who completed a six week, peer led DSMP delivered by community health workers (CHWs) in English, Spanish, and Korean during 2018 2019. A time driven, activity based costing model captured direct implementation costs, CHW workforce turnover, and administrative overhead. Monetized benefits included avoided diabetes related complications, reductions in self reported emergency department (ED) visits and hospitalizations, and quality adjusted life year (QALY) gains from improved medication adherence. Univariate sensitivity analyses tested robustness under conservative assumptions. RESULTS: Total program costs were $179,224; monetized benefits totaled $1,824,213, yielding a net benefit of $1,644,989 and an ROI of 918%, approximately $10 returned per $1 invested. Excluding QALY gains, ROI remained 551%. Self reported ED visits declined from 149 to 82 and hospitalizations from 93 to 24 in the six months following intervention. Over 80% of participants reported housing instability; 72% were Medicaid covered and 16% uninsured. Sensitivity analyses confirmed a positive ROI under all conservative scenarios. CONCLUSIONS: A CHW led, community based DSMP integrated with HRSN screening and referrals delivered substantial economic and public health value among adults facing housing instability and structural barriers to care. Findings support inclusion of DSMP as a covered benefit in Medicaid managed care, value based payment arrangements, and housing access initiatives to advance equitable diabetes outcomes.

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Feasibility and acceptability of contextually adapted AVATAR therapy for distressing voices in Ethiopia and India: a study protocol for the AVATAR3 study

Ward, T.; Alem, A.; Craig, T. K. J.; Sinha Deb, K.; Devi, S.; Fekadu, A.; Gumley, A.; Hanlon, C.; Kelly, R.; Manyazewal, T.; Misganaw, E.; Murcutt, I.; Oshodi, E.; Patil, V.; Sharan, P.; Tesfaye, Y.; Verma, R.; Ul-Haq, S.; Rus-Calafell, M.; Choudhary, R.; Getachew, M.; Hardy, A.; Wondiye, M.; Mihretu, A.; Sood, M.

2026-04-21 public and global health 10.64898/2026.04.21.26348779 medRxiv
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IntroductionIn many Low- and Middle-Income countries (LMIC), access to psychological therapies for psychosis remains extremely limited, contributing to significant treatment gaps and persistent inequalities in care. Novel interventions that are effective, scalable, and culturally acceptable across diverse settings are urgently needed. AVATAR therapy is an innovative digital intervention for distressing voices in psychosis, developed in the UK. The therapy enables voice-hearers to engage in a series of facilitated dialogues with a customized computer-based representation of their main distressing voice. AVATAR3 represents the first initiative to contextually adapt AVATAR therapy and evaluate its acceptability in two LMIC settings (Ethiopia and India). Methods and analysisWe will establish Innovation and Implementation Hubs in Addis Ababa, Ethiopia (Centre for Innovative Drug Development and Therapeutic Trials for Africa (CDT-Africa) at Addis Ababa University (AAU) and Mental Health Service Users Association (MHSUA), Ethiopia) and New Delhi, India (All India Institute of Medical Sciences). Phase 1 employs formative work and diverse stakeholder engagement to inform context-specific adaptations. Reflexive thematic analysis will be used, with data synthesis informed by the Cultural Adaptation of Scalable Psychological Interventions (CASPI) framework and Ecological Validity Model (EVM). Phase 2 tests adapted AVATAR therapy through a parallel case series (n=15 per site, targeting 70% completion rate) measuring feasibility, acceptability, and safety indicators at baseline, 12-weeks, and 24-weeks. Qualitative research will explore the experiences of participants (n=10) and therapists (n=8) at each site. Ethics and disseminationEthical approval has been obtained from Addis Ababa University College of Health Science Institutional Review Board, All India Institute of Medical Sciences (AIIMS) Institutional Review Board and the Kings College London (study sponsor) Research Ethics Committee. Findings will be disseminated to inform the implementation of AVATAR therapy across diverse international settings. Strengths and limitations of this studyO_LIInterdisciplinary and participatory approach C_LIO_LIContextual adaptation of a digital innovation C_LIO_LIExpert by experience leadership and involvement from the conception of the study C_LIO_LIThe study will develop tools and share learning to support future digital mental health innovation across diverse international settings C_LIO_LIThe case-series at each site will not have a control group C_LI