JMIR Research Protocols
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Preprints posted in the last 7 days, ranked by how well they match JMIR Research Protocols's content profile, based on 21 papers previously published here. The average preprint has a 0.04% match score for this journal, so anything above that is already an above-average fit.
Leonhardt, C.; Birrer, D.; Stauffer, M. F.; Toti, J. M. A.; Gallagher, I. J.; Skipworth, R. J. E.; Laird, B.; Kuemmerli, C.
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Importance Non-inferiority trials are becoming increasingly popular in abdominal surgery. The non- inferiority margin is critical in the interpretation and conclusion of these trials. Objective This systematic review aims to assess the methodological and reporting quality of non- inferiority randomized controlled trials in abdominal surgery. Evidence Review Non-inferiority trials were systematically identified by searching Ovid Medline, Embase and the CENTRAL databases from 2006 until December 2025. Randomized controlled trials in adult patients with any type of abdominal surgical intervention in at least one trial arm and a sample size greater than or equal to 100 were eligible for inclusion. The primary outcome was the definition of the non- inferiority margin. Secondary outcomes were the reporting of the non-inferiority margin, the robustness of its estimation, the uncertainty of the point estimate and the adequacy of conclusions. Findings A total of 11 045 trials were identified, of which 101 were eligible, enrolling 44 370 patients. Most trials provided a rationale for the non-inferiority design, while six (5.9%) trials did not. Previous literature was commonly used (n=56; 55.4%), but the non-inferiority margin was most often based on a clinical fixed margin or on historical comparison of the treatment and the active comparator. Based on the margin, investigators tolerated substantially worse outcomes of the treatment compared to the comparator. Conclusions were appropriate based on the confidence interval and the predefined non- inferiority margin in 88 (87.1%) of trials. The clinical judgement of the conclusion was overall adequate. Confidence interval estimations were reported in 16 (15.8%) of trials. Simulation studies were limited by the reporting quality. Conclusions and Relevance Clinical fixed margins are commonly used in abdominal surgery non-inferiority randomized controlled trials, however, substantial shortcomings in reporting limit the interpretability and reproduction of study findings. Based on the findings of this study, guidance on surgical- specific non-inferiority margin definitions is needed.
Yang, T.; Wei, S.; Wang, Y.; Bai, D.
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Background Mirror therapy (MT)-specifically paradigms using mirror visual feedback (MVF)-is widely used in neurorehabilitation; however, mechanistic implementations vary substantially in movement content, rhythmicity and attentional demands. This protocol describes an acute mechanistic, within-participant fNIRS screening study designed to compare three prespecified upper-limb mirror-therapy task paradigms and to quantify associated subjective experience after each condition in healthy adults during a single visit. Methods and analysis This is a single-centre, within-participant, randomised crossover study conducted at Wuhan Wuchang Hospital (Wuhan, China). Healthy adults aged 18-35 years will complete three task conditions once each in a counterbalanced order using a 3*3 Latin-square scheme: UMT1 (task-oriented rhythmic functional movement), UMT2 (open-ended free movement with auditory control), and UMT3 (non-functional rhythmic movement). fNIRS will be acquired using the NirSmart-6000A system during a standardised block design. The primary outcome is ROI-level HbO activation quantified as GLM-derived {beta} estimates within the prespecified primary ROIs (bilateral SM1/M1 and bilateral PMC). Secondary outcomes include ROI-level windowed {Delta}HbO (5-20 s post-onset relative to the immediately preceding rest; descriptive only), ROI-level {Delta}HbR, and post-condition subjective ratings (illusion, immersion, confusion and fatigue; 1-7 Likert). Condition effects will be analysed using linear mixed-effects models with fixed effects for condition and period and prespecified multiplicity-adjusted pairwise contrasts. Ethics and dissemination Ethics approval was obtained from the Ethics Committee of Wuchang Hospital Affiliated to Wuhan University of Science and Technology (Approval No.: 2025-112-01; approved on 2025-08-21). The study is expected to be minimal risk. Findings will be disseminated through publication of this protocol manuscript and subsequent results manuscripts and conference presentations. Trial registration number Chinese Clinical Trial Registry (ChiCTR2600116634). This study is conducted as a prespecified mechanistic sub-study under the overarching registered project.
Marban-Castro, E.; Muhwava, L.; Girdwood, S.; Kemp, T.; Freitas, J.; Kamau, Y.; Otieno, M.; Akach, D.; Morato, A.; Sanz, S.; Fiechter, V.; Erkosar, B.; Watson, M.; Vetter, B.; Haldane, C.; Shilton, S.; Rheeder, P.; Dave, J. A.; Carrihill, M.; Karsas, M.
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Introduction: Continuous glucose monitoring (CGM) offers an advancement over traditional self-monitoring of blood glucose (SMBG) for people living with type 1 diabetes (T1D). However, evidence on the acceptability and feasibility of different CGM use cases in African populations remains limited. Methods: This was a pragmatic three-arm, randomised controlled trial on CGM conducted among people living with T1D in three public healthcare clinics in South Africa. Participants were assigned to Arm 1 (continuous CGM), Arm 2 (periodic CGM), or Arm 3 (SMBG). Diabetes education was provided at all study visits. Feasibility was assessed by adherence to CGM use and through the Glucose Monitoring Satisfaction Survey (GMSS). Diabetes distress was measured by the Diabetes Distress Scale (DDS), health-related quality of life (HRQoL) by the EQ-5D scales, and acceptability using the Theoretical Framework of Acceptability (TFA). Surveys were collected on paper and transferred to OpenClinica. Analyses were performed in R. The trial was registered in the Clinical Trials Registry (NCT05944718) on July 13, 2023. Results: A total of 83 participants were included in Arm 1, 85 in Arm 2, and 80 in Arm 3. CGM mean active time was 55% in Arm 1 versus 69% in Arm 2. The proportion of participants meeting the [≥]70% active time threshold was higher in Arm 2 (52%) than in Arm 1 (34%). Diabetes' distress declined across arms during the intervention period, with no significant difference between arms; distress increased slightly six months post-intervention but remained below baseline. At 6 months, glucose monitoring satisfaction was significantly higher in both CGM arms than in the SMBG arm, and satisfaction increased over time in CGM arms. Health-related quality of life remained stable across arms during the intervention period with no significant difference between arms. High acceptability was observed in both CGM arms, with higher ratings in the periodic arm. Conclusions: CGM was acceptable to people living with type 1 diabetes and feasible to use in public-sector clinics in South Africa, with high acceptability under continuous and periodic use. Health-related quality of life remained stable across arms, and diabetes-related distress declined, during the intervention period, across arms. Glucose monitoring satisfaction rose significantly in both CGM arms compared to SMBG. Periodic CGM might be a promising and potentially more scalable option than continuous use for public-sector care.
Yan, H.; O'Brien, A. J.; Yoon, S. H.; Shaw, V.; vakavosaki, k.
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Background: Stress research in nursing education has largely focused on distress, stressors, and negative outcomes, although challenging experiences may also support motivation, confidence, learning, and growth when appraised positively. Objective: To develop and evaluate the psychometric properties of the Nursing Student Positive Stress Scale (NSPSS). Design: A methodological instrument development and psychometric evaluation study. Methods: The NSPSS was developed using a deductive, theory-driven approach informed by the transactional theory of stress and coping and positive psychology perspectives. Content validity was assessed by an international nursing expert panel. Psychometric evaluation used national survey data from nursing students in New Zealand. Of 539 responses, 507 were analysed. Exploratory factor analysis (EFA) and confirmatory factor analysis (CFA) were conducted using separate subsamples. Internal consistency was assessed using Cronbach's alpha and McDonald's omega, and convergent validity through correlation with Perceived Stress Scale-10 scores. Results: Content validity was strong (I-CVI = .88-1.00; S-CVI/Ave = .975; S-CVI/UA = .800). EFA identified a dominant factor explaining 41.38% of variance (loadings = .528-.735). CFA supported a two-context Academic and Clinical Positive Stress model with correlated residuals between five parallel item pairs, chi-square(29) = 60.49, CFI = .970, TLI = .954, RMSEA = .063, SRMR = .065. Internal consistency was good (alpha = .839; omega = .843). NSPSS scores correlated negatively with PSS-10 scores (r = -.298, p < .001). Conclusion: The NSPSS demonstrated strong content validity, preliminary evidence of structural and convergent validity, and good internal consistency reliability for assessing positive stress appraisal among nursing students. Further validation in independent samples is warranted.
Amolo, P.; Mungai, L.; Karume, A. K.; Kibugi, J.; Mwende, W.; Botella, N.; Haldane, C.; Kamau, Y.; Marban-Castro, E.
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Introduction Continuous Glucose Monitoring (CGM) is considered standard care in high-income countries. There is, however, limited published evidence on CGM use in low- and middle-income countries. The purpose of this study was to assess the usability, acceptability, and feasibility of CGM use among people living with type 1 diabetes (T1D) and caregivers in a low-resource setting. Research Design and Methods This prospective study conducted at the Kenyatta National Hospital purposively enrolled persons aged 4-25 years who had been on management for T1D for at least six months, and caregivers of those under 18 years. Fourty youth living with T1D used CGM for three months in place of self monitoring of blood glucose (SMBG). The System Usability Scale (SUS), a Theoretical Framework of Acceptability-based questionnaire, the Diabetes Distress Scale (DDS), the Glucose Monitoring Satisfaction Survey (GMSS), and a feasibility survey were administered. Outcomes were summarized descriptively, including means, medians, and frequencies using R statistical software. Results The median SUS score was 98.8 (IQR 92.5-100.0). Acceptability was high, and the median total GMSS score improved from 3.73 to 4.73. Among adolescents and adults, the median overall DDS score reduced from 1.54 to 1.36, with reductions in scores in all domains, except for hypoglycemia distress which increased, and physician distress which remained low. Among caregivers, the median overall DDS score declined from 2.05 (moderate distress) to 1.90 (low distress), with modest reductions in teen management and parent-teen relationship distress and a slight increase in personal distress. Median CGM active wear time was 89%. Conclusion This study comprehensively evaluated CGM across usability, acceptability, and feasibility outcomes, with the findings supporting the integration of CGM into routine diabetes management in low-resource settings. The short follow-up period, however, may not capture changing perceptions or long-term adherence.
Jaber, A.; Hughes, L.; Cameron, A. C.; Quinn, T. J.
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Background: Systematic reviews of clinical prediction models increasingly include studies using artificial intelligence (AI) and machine learning (ML) methods alongside traditional multivariable regression approaches. A previously published Excel tool enabled standardised data extraction using the CHARMS checklist and risk of bias assessment using PROBAST. The recent publication of the PROBAST+AI framework, which distinguishes the assessment of model development quality from the assessment of model evaluation risk of bias and assesses applicability in both parts, necessitates an updated digital instrument applicable across prediction modelling methods. Methods: We updated an open-access Excel tool to incorporate the full PROBAST+AI framework. The updated template incorporates structural separation between assessment of model development quality and model evaluation risk of bias, with applicability assessed in both parts. It also incorporates updated signalling questions, including those addressing methodological issues particularly relevant to AI/ML, and automates the generation of summary tables and graphical displays. Results: The updated tool (CHARMS & PROBAST+AI Template) contains 11 worksheets and supports data extraction and appraisal for up to 30 prediction models. Dedicated, linked worksheets enable separate assessment of model development and model evaluation, with Domain 4 distinguishing among Apparent, Internal, and External evaluation settings. Key updates include dedicated assessments for predictor pre-processing, class imbalance handling and recalibration, data leakage prevention, and replication of the full model development pipeline within resampling procedures. Automated sheets dynamically format tables and summary charts covering PROBAST+AI parts. Conclusions: The CHARMS & PROBAST+AI Excel template provides a standardised, user-friendly, and rigorous digital framework for systematic reviewers appraising traditional statistical and AI-driven clinical prediction models.
Boden-Albala, B.; Wing, J.; Landry, M. J.; Castro, M.; Gutierrez, D.; Cardenas, C.; Rousseau, J.; Rahmani, A. M.; Chavez, A.; Ding, X.; Kurzman, A.; Albala, B.
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Background: Cardiovascular disease (CVD) disproportionately burdens underserved communities, where social determinants of health (SDOH) perpetuate persistent disparities. Family-based interventions leveraging social support represent a promising yet understudied approach. We describe the rationale, design, and methods of the Skills-based Educational strategies for the Reduction of Vascular Events in Orange County (SERVE OC) RCT and present baseline characteristics of enrolled families. Methods: SERVE OC is a 2-arm RCT of 190 Latino and Vietnamese families (486 individuals) randomized to the family-based intervention or individual self-management. The intervention was grounded in social network theory while employing community engaged strategies. Primary outcomes include achieving ideal cardiovascular health (CVH) defined by AHA Life's Essential 8 (LE8) and systolic blood pressure reduction at 12, 24, and 36 months. Baseline assessments include demographics, LE8, psychosocial factors, food security, and SDOH. Descriptive statistics and regression analyses examined cohort characteristics and associations between SDOH, food security, and LE8. Results: Over 83% of participants had suboptimal LE8 scores. Average adult total LE8 scores were 66.61 {plus minus}11.96, with physical activity as the weakest domain, compared to an average of 76.52{plus minus}10.15 in children. Greater SDOH burden and food security were associated with significantly lower odds of ideal CVH and lower LE8 scores respectively. Conclusions: SERVE OC demonstrates the feasibility of enrolling families in community-engaged RCT targeting CVD disparities in underserved population. Baseline findings confirm substantial CVD risk and SDOH burden underscoring the need for multi-level, culturally tailored interventions. Trials results will inform scalable, family-focused strategies for CVD prevention across the life course. Clinical Trial Registration: URL: https://www.clinicaltrials.gov/; Unique Identifier: NCT05641519.
Chaturvedi, R. R.; Gracner, T.; Perez-Arce, F.; Suen, S.-c.; Jin, J.; Orriens, B.; Pacula, R. L.; Sexton Ward, A.; Haile, R.; Kapteyn, A.
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Importance: Evidence on GLP-1/GIP therapies is largely derived from trials enrolling selected populations or medical records that miss utilization outside healthcare channels. No nationally representative cohort has characterized real-world uptake, indications, and access. Objective: To characterize GLP-1/GIP prevalence, indication, clinical profile, and access. Design: Prospective cohort study with three GLP-1/GIP surveillance waves (March 2024, December 2024, October 2025). Setting: The Understanding America Study, an address-based, nationally representative panel of approximately 15,000 US adults aged 18+ years initiated in 2014. Participants: UAS participants responding to at least one surveillance wave (n=9150). Exposures: GLP-1/GIP use status (never vs any use, comprising current and former use), self-reported primary indication (diabetes, weight loss, or other), and access pathway (traditional vs non-traditional). Main Outcomes and Measures: Survey-weighted prevalence of GLP-1/GIP use, overall and by indication and access pathway; sociodemographic, cardiometabolic, treatment, and access characteristics; and smartwatch-derived resting heart rate, heart rate variability, maximum activity heart rate, step count, and sleep duration and variability. Results: Among n=9150 adults (1274 with any use; 60.9% female; median age 53 years), weighted prevalence increased 46%, from 8.2% (March 2024) to 12.0% (October 2025) representing 32 million. Weight-loss indications grew, reaching nearly half of use (4.1% to 5.6%); diabetes-indicated use was stable (5.3% to 5.4%). Users carried high cardiometabolic burden (obesity, 68.2%; diabetes, 53.6%) but diverged by indication: diabetes-indicated users were older (median, 59 vs 49 years), whereas weight-loss-indicated users were more often female (69.9% vs 51.3%) and healthier. One in three users (~9 million) had non-traditional access, especially in weight-loss-indicated users, of whom 33% had no conventional prescription; 41% used compounding, online, or foreign pharmacies; and, 43% lacked coverage. Non-traditional users were five times as likely to report an unlisted, likely compounded formulation (19.8% vs 4.1%). All p<0.05. Conclusions and Relevance: Real-world GLP-1/GIP use has grown rapidly and diversified substantially in indication, access, and population profile. One in 3 users obtained treatment through nontraditional channels largely invisible to claims data, raising long-term safety, efficacy, and coverage questions. GLIMMER provides a public, nationally representative longitudinal evidence base for future payer and provider decisions.
Manikam, L.; Fatima, A.; Patil, P.; Mayadewi, C. A.; El Khatib, T.; Drazdzewska, J.; Oyebode, O.; Llewellyn, C. H.; Webb-Martin, K.; Irish, C.; Archibong, M.; Gilmour, J.; Kalungi, P.; Batura, N.; Shringarpure, K.; Lakhanpaul, M.; Heys, M.; NEON Steering Team,
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South Asian communities in the UK experience disproportionate maternal and child health inequalities linked to non-recommended infant feeding practices, limited health literacy, and socioeconomic constraints. Participatory learning and action (PLA) is effective in low- and middle-income countries, but high-income evidence is scarce. This pilot assessed the feasibility of a community facilitator-led PLA intervention to improve infant feeding among South Asian families in East London. A three-arm pilot feasibility cluster randomised controlled trial (ISRCTN10234623) was conducted in Tower Hamlets and Newham, East London (May-September 2022), with 12 wards randomised 1:1:1 to face-to-face PLA, online PLA, or usual care. Multilingual community facilitators delivered eight biweekly sessions over 14 weeks. Feasibility outcomes were assessed against prespecified Go/Stop criteria; exploratory outcomes included child feeding behaviours (Children's Eating Behaviour Questionnaire, CEBQ), parental feeding style (Parental Feeding Style Questionnaire, PFSQ), and child BMI Z-scores. Of 263 enrolled participants, 261 had a recorded trial arm allocation; consent to the pilot feasibility study was 70.7% (186/263; 95% CI 65.0-75.9%) meeting the [≥]50% Go criterion. Attendance was 37% (Tower Hamlets 59%, Newham 29%), below the [≥]80% Go threshold. Six-month retention was 54.8% (Tower Hamlets 78%, Newham 48.5%; 95% CI 41.8-55.3%), triggering the Definite Stop criterion. Significant baseline imbalances included BMI Z-score (p = 0.005), ethnicity, borough, and education; no between-arm BMI differences were observed at follow-up (p = 0.249). CEBQ and PFSQ baseline completion was 24.5% and 23.0%, with no usable follow-up data. PLA Phases 3 and 4 were not completed by any group; all participants providing feedback reported it acceptable. Recruitment was feasible and the intervention acceptable, but a Definite Stop criterion was triggered in Newham, no group completed the full PLA cycle, and outcome data were insufficient for evaluation. A definitive trial requires stratified randomisation, digitised multilingual data collection, participant reimbursement, and explicit PLA phase-completion criteria.
Reese, T.; Audet, C.; Ancker, J.; Wright, A.; Marcovitz, D.; Kast, K. A.; Bridges, J.; Tindle, H.; Shah, M.; von Horn, A.; Matheny, M. E.
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Introduction: Risk of recurrent opioid use during buprenorphine-naloxone (bup-nx) treatment is dynamic and remains elevated after initiation, with vulnerability shaped in part by treatment intensity and gaps between visits, yet routine outpatient care relies on episodic encounters and retrospective data. This mismatch can delay recognition of emerging instability and limit timely treatment adjustments. This paper reports the development and specification of an intervention strategy to address this mismatch. Methods: We used a structured, multi-phase design process to specify and configure a measurement-based care (MBC) strategy for bup-nx treatment (Bup-MBC) in outpatient addiction clinics through three phases: (1) a systematic review of patient-reported outcome measures (PROMs) for substance use treatment; (2) a qualitative needs assessment using the Theoretical Domains Framework and COM-B (Capability, Opportunity, Motivation-Behavior) model to identify gaps in risk monitoring, agency, and trust; and (3) iterative co-design with multidisciplinary clinicians to refine workflow fit and trust-preserving use of data. Patients informed item and feedback content during the needs assessment but did not participate in the co-design cycles. Results: Bup-MBC integrates (1) brief between-visit PROMs (e.g., withdrawal, craving, adherence); (2) immediate non-punitive patient feedback; (3) clinician-facing summaries and non-directive prompts in the electronic health record (EHR); and (4) an opt-in between-visit outreach pathway with predefined safety triggers, all configured within existing EHR and patient portal infrastructure. It targets patient and clinician capability to recognize changes in risk, opportunity for action through structured monitoring and visit preparation, and trust and agency through non-punitive communication, without adding substantial burden. The full measure set, severity bands, and question-to-action map are provided as supplementary material. Key trade-offs included prioritizing single-item measures for feasibility, balancing opt-in outreach with safety overrides, and assuming routine clinician use of summaries. Conclusion: This development study specifies an EHR-integrated MBC strategy for outpatient bup-nx treatment. As single-center design work with co-design limited to clinicians and delivery contingent on portal or text-message access, its outputs are hypotheses about mechanism and fit rather than demonstrated effects. Feasibility studies are needed to evaluate uptake, acceptability, workflow fit, and effects on treatment.
Chin, A. T.; Zhu, N.; Vangala, S.; Woo, H.; Wisk, L. E.; Kingsley, T.; Mafi, J. N.; Lukac, P. J.
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BACKGROUND Generative AI (genAI) chart summarization tools embedded in electronic health records (EHRs) are being rapidly deployed across U.S. health systems. Although these tools represent a promising solution to alleviate cognitive burdens, their effects have not been examined in randomized-clinical trials (RCTs). METHODS In this pragmatic RCT at a single academic health system, 284 outpatient clinicians across forty-two specialties were assigned 1:1 to Epic's outpatient chart summarization tool or a usual-care control arm over 90 days, from February 23 to May 23, 2026. The primary outcome was physician task load (PTL) adapted for pre-charting. Prespecified exploratory outcomes included additional validated psychometrics as well as usability, safety, and time-based measures. Descriptive statistics included interaction and usage of the tool. RESULTS Of 74,474 AI chart summaries generated, 14.2% were interacted with by a clinician; the proportion of generated summaries interacted with declined from 21.5% in month 1 to 10.5% in month 3, and the proportion of clinicians using the tool at least once per month declined from 88.7% to 66.2%. The adjusted between-arm difference in PTL at follow-up favored the intervention arm (scale 0-400; -27.4; 95% CI, -49.4 to -5.3; P=0.02). Among the Professional Fulfillment Index (PFI; scale 0-4, lower=better) psychometrics, overall burnout (-0.20; 95% CI, -0.38 to -0.01) and work exhaustion (-0.24; 95% CI, -0.47 to -0.02) were lower in the intervention arm, with little difference in overall professional fulfillment (+0.04; 95% CI, -0.16 to 0.25). Charting time per encounter showed no significant between-arm difference during steady state (-1.2 seconds; 95% CI, -19.0 to 16.6). The net promoter score was -22, indicating that on average, clinicians did not recommend the tool. Among free-text respondents, 57.1% reported at least one concern, most commonly tool limitations or inaccurate information. No adverse patient safety events or near-misses were reported. CONCLUSION An EHR-integrated AI chart summarization tool modestly reduced physician task load and was associated with lower burnout, without time savings and against declining engagement. Sustained usage and oversight of reported inaccuracies remain open challenges.
Singh, A. M.; Yeh, T.-C.; DeBoer, C.; Al-Moujahed, A.; Lin, J. B.; Smith, S. J.; Sanislo, S.; Janjua, K. A.; Lin, T.-C.; Almeida, D. R. P.; Mruthyunjaya, P.; Mahajan, V. B.
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Purpose: To evaluate the safety, procedural performance, sample recovery, and surgeon preference of an ophthalmic needle designed specifically for anterior chamber (AC) paracentesis. Methods: In this multicenter study, AC paracentesis was performed in clinic and operating-room settings using a 32-gauge x 4-mm needle with low dead space. The procedure was evaluated using a standardized physician survey. Prespecified outcomes included procedure-related adverse events (primary outcome), needle entry and handling, aspiration and sample recovery, comparative performance versus a 30-gauge needle, and physician preference for future use. Results: A total of 110 needle uses by eight surgeons were included. No ocular complications occurred, including lens or iris injury, hyphema, AC collapse, wound leak, hypotony, infection, or retinal complication, and no procedure required needle exchange or conversion to another device. Two technical events without ocular sequelae were noted, in which needle entry was partial thickness and did not reach the AC (1.8%; exact 95% CI, 0.2%-6.4%). Physicians rated needle entry, handling and sample recovery as good or excellent. Compared with a 30-gauge needle, the study needle was rated as at least comparable across all assessed domains. All surgeons rated it better or much better for intra-procedural safety and preferred it for future AC taps. Conclusions and Relevance: This short, 32-gauge low-dead-space ophthalmic needle demonstrated a favorable safety profile and was preferred over a 30-gauge needle by all surgeons. As aqueous humor liquid biopsy expands in clinical diagnostics and trials, an ophthalmic-specific needle design may help improve the consistency and safety of aqueous humor collection for molecular analysis and broader clinical use. Keywords: Anterior chamber paracentesis; Aqueous humor; Liquid biopsy; Low dead space; Ophthalmic needle
Mengi, A.; Bagita-Vangana, M.; Tesine, P.; Laman, M.; Bolnga, J. W.; Ome-Kaius, M.; Kulimbao, J.; Mase, J.; Mal, L. S.; Mnjala, H.; Lee, G.; Cassidy-Seyoum, S. A.; Thriemer, K.; Unger, H. W.
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Disseminating study results to participants is an ethical responsibility for researchers but remains uncommon in low- and middle-income countries, and participants preferences for receiving study results are poorly understood. This study examined study result dissemination preferences among pregnant women in a phase III malaria prevention trial in Papua New Guinea (PNG). Participants completed an interviewer-administered questionnaire (survey) assessing their interest in and motivation for receiving trial results and preferences for dissemination methods and content. Associations between participants characteristics and dissemination preferences were explored using multivariable logistic regression analysis. Of 1172 trial participants, 96.0% (1125/1172) completed the survey, and of these 99.6% (1121/1125) wanted to learn about the trial results. The main motivation factors driving participants interest were an acknowledgment of their contribution to research (51.7%; n=579) and a better understanding of the study (45.0%; n=505). Most participants (78.9%; n=884) wanted to learn about the trial findings through written summary and a group meeting with other participants at the nearest clinic (31.1%, n=349). Multivariable regression analysis indicated that participants from rural/peri-urban clinics were more likely to choose non-electronic media dissemination approaches such as a group meeting as compared to urban-dwelling participants. Frequently selected items (>50% of participants) for content included information regarding good results of the study, purpose of the study, medical treatment advances, results specific to me, and how study was conducted. There was heterogenicity in the preference for dissemination content: compared to urban clinics rural clinics are less likely to want to learn about how and why study was conducted and medical and scientific advances. Overall, the majority wanted to learn about trial results, highlighting the importance of integrating dissemination into research activities in PNG. Variation in preferences for mode and content of dissemination between study clinics suggests that dissemination activities could be tailored to local context and preferences.
Yao, R.; Wi, C.-I.; Beenken, M. J.; Watson, D.; Wheeler, P. H.; Finch, M.; Kelleher, D. P.; Anil, G.; Anderson, T.; Madden, K.; Okuno, S. H.; Odedina, F. T.; Westfall, E. C.; Park, E. Y.; Sharma, P.; Dugani, S.; Foss, R. M.; Hidaka, B. H.; Sosso, J. L.; Sabarish, S.; Singh, G.; Lugo-Fagundo, N.; Howick, J.; Kim, W. R.; Calvin, A. D.; Walker-Mcgill, C. L.; Rennert, L.; Juhn, Y. J.; Cerhan, J. R.; Lynch, B. A.
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Purpose: This study assesses the association between colorectal cancer (CRC) screening and a validated, housing-based measure of individual-level socioeconomic status (SES, called HOUSES hereafter) within rural communities and determines whether HOUSES-integrated geospatial analysis can be used to tailor interventions. Methods: We used CRC screening data from a subset of Mayo Clinic Midwest patients living in cities without ready access to routine care in the Mayo Clinic Health System in 2019 to represent rural communities. At the individual level, we assessed the association between CRC screening rates and the HOUSES index, adjusting for age, sex, race/ethnicity, comorbidity, distance from home address to clinic, and area deprivation index, using a multilevel mixed-effects logistic regression model. Additionally, we conducted geospatial analysis to examine the correlation between hotspots of 1) lower CRC screening rates and 2) lower SES of the subject population (HOUSES quartile 1). Findings: Among 34,489 individuals (median age 64.0 years, 52.4% female), those with the lowest SES (HOUSES Q1) had 37% lower odds of being CRC screening adherent than those with the highest SES (HOUSES Q4) (adj. OR [95% CI]: 0.63 [0.58-0.69]). In the 14 identified HOUSES Q1 hotspots, there was a significant correlation in counts of HOUSES Q1 and low CRC screening (correlation coefficient=0.81). Conclusion: Lower SES was significantly associated with lower CRC screening among rural populations. HOUSES-enabled geospatial analysis identified geographic hotspots with lower CRC screening rates for targeted interventions to address disparities in CRC screening in rural communities. HOUSES may be a useful digital tool for cancer preventive care and research.
Zhang, Z.; Qadir, M. I.; Ramchand, R.; Belwadi, M.; Ball, R. P.; Konstantinopoulos, K.; Abbey, E. M.; Ernsberger, K. T.; Guzman, M. J.; Hendren, S.; Holcomb, B. K.; Robb, B. W.; Stankowski, T.; Waters, J. A.; Stefanidis, D.; Bilimoria, K. Y.; Mohanty, S.; Kolbinger, F. R.
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Surgical video interpretation is a promising medical artificial intelligence application. However, no existing video annotation method preserves the spatiotemporal complexity of surgeon reasoning. Here we show that verbal reasoning and visual attention can be converted into structured, machine-actionable records of intraoperative behaviours. Our method decomposes transcribed verbal commentary into video-anchored semantic feedback chunks, which are classified via a large language model, with spatial grounding to surgical scenes via eyegaze or cursor tracking. We demonstrate method validity and scalability on structured and unstructured annotation tasks. For quality feedback on full-length colorectal procedures, the method reached near-human fidelity for chunking (mean cosine similarity: 0.95, SD: 0.01) and semantic classification across observations (mean Cohen's kappa: 0.71, SD: 0.07) and evaluative triggers (mean Cohen's kappa: 0.67, SD: 0.14), with excellent usability ratings. For structured critical view of safety assessment in laparoscopic cholecystectomy, implicit annotation yielded excellent agreement with explicit reviewer ratings (Cohen's kappa: 0.83, 0.49 and 0.81 across three criteria). We anticipate this method will advance surgical data science by enabling scalable construction of meaningfully annotated surgical video datasets.
Edmond, E. C.; Dreyer, A. J.; Winston, A.; Khoo, S. H.; Joska, J.; Nightingale, S.
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Background Computerised cognitive testing may address the global challenge in identifying cognitive changes in people living with HIV scalably and affordably. We assessed a computerised battery (CB) of cognitive tests, in a prospective cohort (CONNECT) of people with HIV in a low-income peri-urban area of Cape Town, South Africa during a national programmatic switch from efavirenz- to dolutegravir-based antiretroviral therapy (ART). Methods We recruited 170 people with HIV and 91 people without HIV (controls) (140[82%] and 41[45%] followed up). The CB and gold-standard pen&paper cognitive testing (P&P) were performed at both timepoints. Technology familiarity/use questionnaire data were also collected. We compared performance in detecting lower group-level cognitive performance associated with efavirenz treatment. Furthermore, the CB was compared to P&P in classifying individuals with low cognitive performance, correlation of global test scores and domain-level scores between batteries, and practice effects between timepoints. Exploratory principal component analysis was also performed. Results People with HIV on efavirenz at baseline had lower performance on the computerised battery than controls, {Delta}T=2.6, p=0.0047. This difference was lost after switching to dolutegravir-based ART at follow-up. CB and P&P global T were moderately correlated (R2=0.203, p<0.001), and the CB performed moderately in classification of low cognitive performance against the gold standard (AUC 0.70, sensitivity 0.52, specificity 0.76, PPV 0.40, and NPV 0.84). Selecting the first three principal components improved both classification of low cognitive performance (AUC 0.77) and correlation strength with P&P global T (R2=0.3, p<0.001). The CB did not show practice effects. Most participants owned a mobile phone (95%, 85.9% of these smartphones). Performance was better in smartphone owners ({Delta}T=1.8) and computer owners (23%, {Delta}T=1.8). Conclusions Delivering computerised cognitive testing was feasible in this low-income southern African setting. The CB showed reasonable construct validity (detecting known lower cognitive performance associated with efavirenz-ART) and may detect broad cognitive characteristics such as processing speed and accuracy. However, correlation of CB results with gold standard P&P testing was low-moderate and may limit its applicability as a diagnostic tool. This might be improved by including a wider range of cognitive domains tested in the CB, or data driven analysis. Brief CBs may fulfil an initial screening role, followed by more detailed clinical assessment.
Khodi Babaroudi, E.; Pham, M. H. X.; Lenz, I. T.; melgaard, e. l. r.; Grand, J.; Hove, J. D.; Seven, E.
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Introduction: Nicotine Pouches are increasingly used as a smokeless alternative to cigarettes and other nicotine products, yet their acute cardiovascular effects remain poorly documented. While nicotine's impact on heart rate and electrocardiogram (ECG) parameters is well-documented in smoking, no trials have evaluated these effects specifically for nicotine pouches. Methods: This study is a single-center, double-blind, placebo-controlled, crossover trial which will include 20 healthy adult nicotine users. Participants will undergo three sessions, receiving either a placebo, 6 mg, or 14 mg nicotine pouch in random order. Heart rate obtained by an ECG and various other ECG parameters, vital signs, and subjective symptoms will be measured at baseline, and multiple time points over 30 minutes. Conclusions: This study aims to determine whether nicotine pouches cause acute changes in heart rate, ECG parameters, vital signs, and self-reported symptoms. We hypothesize that higher nicotine pouch does will lead to measurable increases in heart rate and other autonomic effects compared to placebo.
Wojcik, S.; Rulkiewicz, A.; Domienik-Karłowicz, J.
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Large language models perform well on medical examinations, but users routinely challenge their answers and invoke professional roles, and it is unclear what a system does when a medical credential and a stated task-specific accuracy point in opposite directions. In a factorial experiment on 480 items from four Polish specialty examination sets and three consumer large language model systems (ChatGPT, Claude, Gemini), each item and system received eleven independent conversations. Conditions crossed attributed source role (medical student, experienced specialist), stated prior accuracy on similar questions (2/10, 8/10) and suggestion correctness. The primary outcome was adoption of a prespecified incorrect option when the baseline answer matched the official key, comparing a specialist described as 2/10 with a student described as 8/10. Baseline agreement with the key was 87.2% across 15,683 analyzable conversations. The incorrect option was adopted more often from the specialist described as 2/10 than from the student described as 8/10 (10.2% vs. 7.6%; adjusted risk difference +2.82 percentage points, 95% CI +0.65 to +4.99). Estimates varied across the three systems and only one system-specific interval excluded zero. In a prespecified exploratory analysis with a shared eligibility rule, correct suggestions were adopted far more often than incorrect ones (risk difference +35.7 percentage points, 95% CI +30.8 to +40.7), indicating selective rather than indiscriminate compliance. An incorrect suggestion from a specialist with low stated accuracy was therefore slightly more influential than the same suggestion from a student with high stated accuracy, although the difference was modest and varied across systems. Agreement reached only after a user has disclosed a preferred answer should not automatically be treated as an independent second opinion, and medical large language model systems should be evaluated on how they revise answers after such disclosure, not solely on initial accuracy.
Wain, K. F.; Carroll, N. M.; Maclennan, A. J.; Hixon, B.; Steiner, J.; Ritzwoller, D. P.
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Purpose: Lung cancer screening (LCS) with low-dose computed tomography (LDCT) reduces lung cancer mortality, yet screening participation remains low. We evaluated whether a brief informational video nudge delivered immediately before a scheduled clinical encounter increased LCS ordering and baseline LCS completion. Patients and Methods: We conducted a randomized feasibility trial within Kaiser Permanente Colorado from March through October 2025. LCS-eligible patients with an upcoming primary care or pulmonology appointment were assigned to intervention or usual care based on birth month. Intervention patients were split into two group, a group who received the LCS informational video nudge via text message within 24 hours of an eligible appointment; and second group who received the text plus a QR code video link during appointment rooming. Outcomes included LCS orders, baseline LCS-LDCT completion, and video engagement. Multivariable logistic regression was used to evaluate factors associated with LCS ordering. Results: Among 1,093 patients, 549 were assigned to intervention and 544 to usual care. Intervention patients were more likely to receive an LCS order within 1 day of their appointment (22.6% vs 16.4%; p=.010) and any time during follow-up (32.6% vs 24.1%; p=.002). Baseline LCS-LDCT completion was 51% higher in the intervention group, although the difference was not statistically significant (8.6% vs 5.7%; p=.078). Among the intervention group, 93 individuals (17%) viewed the video, generating 114 total views, and viewers watched an average of 79% of the video. Most views (82.5%) occurred through text-message delivery rather than QR codes. Conclusion: A brief, low-burden LCS informational video delivered immediately before a clinical encounter and integrated into existing workflows significantly increased LCS ordering and was associated with higher screening completion. Timely, scalable digital nudges may provide an effective strategy for improving LCS participation. Based on the observed effectiveness, feasibility, and efficiency of the intervention, KPCO incorporated the behavioral nudge into standard clinical care in February 2026.
Barzideh, A.; Devasahayam, A. J.; Marzolini, S.; Munce, S.; Sibley, K. M.; Inness, E. L.; Mansfield, A.
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Background: Aerobic exercise is recommended during stroke rehabilitation to improve cardiorespiratory fitness and support recovery; however, participation rates remain low. While institutional and system-level barriers have been widely examined, less is known about how individual patient factors influence engagement in aerobic exercise during rehabilitation. Objectives: We aimed to determine whether depressive symptoms, apathy, self-efficacy and outcome expectations for exercise, perceived barriers, or past exercise history were associated with aerobic exercise participation in stroke rehabilitation. Methods: In this prospective cohort sub-study, adults admitted to in- or out-patient stroke rehabilitation at three urban hospitals completed validated questionnaires assessing depressive symptoms, apathy, exercise self-efficacy, outcome expectations for exercise, perceived barriers to being active, and premorbid exercise history. Participants were separated into two groups for analysis: those who completed aerobic exercise during rehabilitation and those who did not. Equivalence testing and between-group comparisons were performed. Results: Sixty-two participants were enrolled; 16 participated in aerobic exercise and 46 did not. Groups were not equivalent on any individual-level factors. Compared to non-participants, those who performed aerobic exercise had significantly higher depressive symptom scores (p=0.0025) and lower self-efficacy for exercise (p=0.0087). Non-participants demonstrated significantly higher apathy (p=0.0007). No significant differences were found for outcome expectations, perceived barriers, or exercise history. Conclusion: Depressive symptoms and lower self-efficacy did not impede aerobic exercise participation during rehabilitation. Increased apathy, however, was associated with non-participation. Findings highlight the need for individually tailored aerobic exercise prescriptions that consider motivational and affective factors to optimize engagement during stroke rehabilitation.