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Nevin Manimala Statistics

Atrial dysfunction: a contrast-free marker for HFpEF in obese diabetics-insights from comprehensive CMR and serum biomarker analyses

Cardiovasc Diabetol. 2025 Jun 18;24(1):258. doi: 10.1186/s12933-025-02808-3.

ABSTRACT

BACKGROUND: The diagnostic criteria for HFpEF remain inconsistently defined, further confounded by comorbidities such as obesity and type 2 diabetes mellitus (T2DM), which are thought to contribute to its pathogenesis via chronic pro-inflammatory mechanisms. This study aimed to evaluate the relationship between advanced cardiac magnetic resonance (CMR) imaging and pro-fibrotic and inflammatory serum biomarkers, assessing their potential to discriminate HFpEF from associated comorbid conditions.

METHODS: This was an exploratory analysis of a prospective cohort study of 35 obese/overweight participants (mean age 64 ± 8 years, 23% females), including 16 with T2DM, 13 with HFpEF (NYHA II-III) and T2DM, and 6 healthy controls. All subjects underwent comprehensive contrast-enhanced CMR at a 3 T scanner (Philips Ingenia, The Netherlands), including assessment of left ventricular and left atrial (LA) volumetry and function, myocardial perfusion reserve (MPR), and diffuse fibrosis imaging (ECV). Obtained serum biomarkers were Pentraxin-3, Galectin-3 and Interleukin-1 Receptor-Like 1 (IL1RL1). Statistical analyses included one-way ANOVA, Tukey test, Pearson’s correlation, regression and receiver operating characteristic analyses, and intra-class correlation.

RESULTS: In multivariable regression, impaired measures of LA structure and function emerged as the only independent discriminators of HFpEF, with LA maximum volume showing an OR of 1.13 (95% CI 1.05-1.28), reservoir strain of 0.71 (95% CI 0.44-0.89), conduit strain of 0.57 (95% CI 0.32-0.82) and booster strain of 0.70 (95% CI 0.48-0.89) per unit increase. No differences in MPR nor ECV were observed between the groups. While serum biomarkers Galectin-3 and Pentraxin-3 were significantly higher in HFpEF vs. obese controls (16.1 ng/ml ± 3.8 ng/ml vs. 10.6 ng/ml ± 3.7 ng/ml, p = 0.011, and 0.84 ng/ml ± 0.67 ng/ml vs. 0.21 ng/ml ± 0.05 ng/ml, p = 0.031, respectively), these biomarkers remained within normal limits and showed only moderate correlations with CMR metrics. Highest inter-study reproducibility was seen in MPR (ICC: 0.94), LA Reservoir Strain (ICC: 0.84) and serum biomarkers (ICC: 0.087-0.93).

CONCLUSION: CMR markers of diffuse fibrosis and microvascular dysfunction may not differentiate HFpEF from obese or diabetic controls. However, left atrial function assessment may evolve to be a reproducible and practical CMR marker, effectively distinguishing HFpEF independent of fibrotic remodeling.

PMID:40533773 | DOI:10.1186/s12933-025-02808-3

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Evaluating the Impact of Diabetes and Metformin on Painful Neuromas After Lower Extremity Amputations

Ann Plast Surg. 2025 Jun 4. doi: 10.1097/SAP.0000000000004419. Online ahead of print.

ABSTRACT

BACKGROUND: Painful neuromas are common cause of residual limb pain following lower extremity amputation, yet its incidence in diabetic populations remains unestablished. While diabetes is thought to reduce neuroma risk due to impaired nerve regeneration, the role of metformin on this process remains unclear. This study aims to explore the association of diabetes severity and metformin therapy on painful neuroma formation following lower extremity amputations.

METHODS: This retrospective cohort study used TriNetX Research Network to identify adult patients (≥18 years) who underwent lower extremity amputation between January 2016 to February 2024. Patient cohorts were identified using International Classification of Disease-10 and Current Procedural Terminology codes. Patients were stratified by diabetic status, hemoglobin A1c levels, and metformin use. Propensity score matching was performed and adjusted for demographics, comorbidities, and medications. Risk differences, risk ratios, and odds ratios with corresponding 95% confidence intervals were calculated to quantify the association between the exposure and the outcome. Statistical significance was set at P < 0.05.

RESULTS: A total of 16,090 patients underwent lower extremity amputation, 9994 (62.1%) were diabetic, while 6096 (37.9%) were nondiabetic. The overall incidence of symptomatic neuromas was lower in diabetic patients (0.61%) compared to the nondiabetic group (1.67%). After propensity score matching, 5196 diabetic and 5104 nondiabetic amputees were identified. Diabetes was associated with a significant reduction in neuroma risk [risk difference of -0.893% (95% CI: -1.29% to -0.496%); P < 0.0001]. Patients using metformin at the time of surgery had a higher incidence of painful neuroma (0.718%) compared to nonusers (0.424%) (P = 0.127, odds ratio = 1.69). There was no significant difference in neuroma rates between those with hemoglobin A1c levels 6.5%-8.0%, 8.1%-10%, and >10%.

CONCLUSIONS: Diabetes was associated with a lower painful neuroma risk after amputation, suggesting a possible protective role of hyperglycemia-induced nerve regeneration alterations. Metformin use had no significant impact on painful neuroma rates. These findings challenge assumptions about glycemic control and neuroma formation, highlighting the need for further research on metabolic influences in postamputation nerve healing and pain management.

PMID:40532227 | DOI:10.1097/SAP.0000000000004419

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Nevin Manimala Statistics

A New Generation of Clinical Endpoints for Critical Care Trials

Am J Respir Crit Care Med. 2025 Jun 18. doi: 10.1164/rccm.202505-1134ED. Online ahead of print.

NO ABSTRACT

PMID:40532217 | DOI:10.1164/rccm.202505-1134ED

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Nevin Manimala Statistics

Effects of a Mobile Storytelling App (Huiyou) on Social Participation Among People With Mild Cognitive Impairment: Pilot Randomized Controlled Trial

JMIR Hum Factors. 2025 Jun 18;12:e70177. doi: 10.2196/70177.

ABSTRACT

BACKGROUND: As the prevalence of mild cognitive impairment (MCI) among older adults increases, so does the need to enhance social participation and cognitive functions through innovative interventions. Digital storytelling in group settings holds potential not only to foster social connections but also to integrate with traditional in-person activities, leveraging both for greater impact.

OBJECTIVE: This study aimed to evaluate the feasibility of the Huiyou app in supporting group-based storytelling activities, aiming to enhance social participation for people with MCI. We focused on the app’s ability to improve storytelling goal attainment, social connectedness, self-efficacy, and subjective happiness, comparing these outcomes between the experimental and control groups.

METHODS: We randomly assigned 20 participants with MCI to either an intervention group or a control group, engaging them in the use of the Huiyou digital storytelling app over 4 weekly sessions of 45 minutes each. We measured outcomes through the Assessment of Life Habits questionnaire (77 items), particularly outdoor activities and interpersonal relationships; the Social Connectedness Scale-Revised (20 items); the General Self-Efficacy Scale (10 items), focusing on coping self-efficacy; and the Subjective Well-Being Scale (SWBS; 20 items), with a special emphasis on self-acceptance.

RESULTS: The sample had an average age of 69.7 (SD 3.21) years, with no significant (P=.23) baseline differences between groups in age, sex, or educational background. Cognitive function, assessed via the Montreal Cognitive Assessment-Chinese questionnaire, also showed no significant differences at baseline (P=.20). Specifically, significant enhancements in the outdoor activity (mean value difference 0.171, SD 0.353; Cohen d=1.046; P=.03) and interpersonal adaptation experience subscales of the SWBS (mean value difference 0.167, SD 0.247; Cohen d=1.290; P=.01) were noted. Notably, storytelling performance improved markedly, evidenced by increases in story sharing duration and complexity. Although overall improvements in Assessment of Life Habits (P=.14), Social Connectedness Scale-Revised (P=.59), and Subjective Well-Being Scale (P=.26) scores were not statistically significant, the large effect sizes observed suggest potential benefits of the Huiyou app that might be obscured by the study’s small sample size.

CONCLUSIONS: This study indicates that the Huiyou mobile storytelling app is feasible to enhance social participation and specific aspects of social functioning such as interpersonal adaptation for people with MCI. Despite the lack of significant changes in overall scores for key scales, observed effect sizes highlight a positive trend that merits further investigation. These results advocate for the continuation of digital intervention development to improve quality of life and social integration for individuals with MCI.

PMID:40532206 | DOI:10.2196/70177

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Nevin Manimala Statistics

Perspectives and Experiences of Family Caregivers Using Supportive Mobile Apps in Dementia Care: Meta-Synthesis of Qualitative Research

JMIR Mhealth Uhealth. 2025 Jun 18;13:e65983. doi: 10.2196/65983.

ABSTRACT

BACKGROUND: Supportive mobile apps are effective tools for family caregivers of persons with dementia to obtain online information and psychological support. Nevertheless, details about the experiences of family caregivers of persons with dementia using mobile apps are limited.

OBJECTIVE: This study aimed to synthesize the perspectives and experiences of family caregivers of persons with dementia regarding supportive mobile apps.

METHODS: We conducted a synthesis of qualitative research and searched 7 English-language databases and 4 Chinese-language databases. We included qualitative studies (peer-reviewed studies and gray literature) written in English and Chinese on the perspectives and experiences of family caregivers of persons with dementia regarding supportive mobile apps published from database establishment to March 2025. Two researchers independently screened the literature and used the JBI Critical Appraisal Checklist for Qualitative Research to conduct quality assessments on the final included studies. Themes were integrated using the 3-stage thematic synthesis approach by Thomas and Harden.

RESULTS: A preliminary search yielded 4772 studies, of which 12 (0.25%) met the criteria. The included studies were from 7 different countries or regions, of which the only low- or middle-income country was Brazil. The studies involved a total of 232 family caregivers, most of whom were older adults and female. The integration of extracted content resulted in 4 themes: dynamic changes in value perception-complex attitudes toward mobile app adoption; from tools to partners-a technology-empowered multidimensional support system for family caregivers; external and internal barriers-challenges in family caregivers’ use of mobile apps; and person-centered design-future directions for improving mobile apps.

CONCLUSIONS: This study found that family caregivers’ attitudes toward using supportive mobile apps are influenced by their perceived value of mobile apps and their caregiving burden. In addition, such supportive mobile apps serve as valuable tools for family caregivers to enhance their caregiving abilities and efficiency, alleviate the burden of care, improve negative emotions, foster social connections, and promote self-care. Future mobile app design needs to address obstacles such as design flaws, family caregivers’ lack of technological literacy, time constraints, concerns about privacy breaches, and other device-related issues, with particular attention to the ease of use of mobile apps. Meanwhile, developers need to commit to designing personalized and multifunctional mobile apps as well as promote online collaboration among members of the care network. Overall, our study offers an important reference for developing person-centered supportive mobile apps for family caregivers of persons with dementia.

TRIAL REGISTRATION: PROSPERO CRD42024510905; https://www.crd.york.ac.uk/PROSPERO/view/CRD42024510905.

PMID:40532203 | DOI:10.2196/65983

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Nevin Manimala Statistics

Development of a Serious Game to Simulate Neonatal Intensive Care Unit Experiences: Collaborative Quasi-Experimental Study

JMIR Form Res. 2025 Jun 18;9:e73009. doi: 10.2196/73009.

ABSTRACT

BACKGROUND: Opportunities for neonatal intensive care unit (NICU) training are limited for medical and nursing students due to patient safety concerns and the complexities of neonatal care. In addition, the COVID-19 pandemic significantly disrupted clinical training opportunities, further underscoring the need for alternative educational tools that can provide immersive and practical learning experiences. Serious games have garnered attention as potential tools for medical education; however, few are designed to simulate the complete NICU environment and its unique challenges.

OBJECTIVE: To address the educational gaps in neonatal care training, we aimed to develop and evaluate a serious game that provides a comprehensive NICU simulation experience for students and the general public.

METHODS: The game was developed over 14 months by a collaborative team that included a neonatologist, 4 medical students, and 1 art student, with a total cost of US $10,000. Initially created in TyranoBuilder (STRIKEWORKS), the game was later redeveloped in Unity with Naninovel to support multilingual functionality. Structured as a 6-chapter visual novel, the game follows a high school student observing the NICU during a hospital internship. Scenario-based decision-making and interactive dialogues guide the player through both the clinical and emotional aspects of neonatal care. After completing the game, players were invited to participate in an optional web-based survey that assessed demographic information, gameplay quality, and educational value using Likert scales. Descriptive and inferential statistics were used for data analysis.

RESULTS: The game, titled First Steps in the NICU, was released for iOS, Android, and Steam. As of May 2025, it has been downloaded 2799 times (2260 on iOS and 539 on Android). A total of 160 survey responses were collected, with 46.3% of respondents identifying as health care professionals or students. The majority of participants were female (114/160, 71.3%) and aged 20-29 years (59/160, 36.9%). Mean scores for length, difficulty, and gameplay were 3.05 (SD 0.62), 2.49 (SD 0.76), and 3.65 (SD 0.77), respectively, indicating a well-balanced design. The educational usefulness of the game received high ratings: empathy with the story (4.24), usefulness for knowledge acquisition (4.16), and effectiveness of serious games as a learning tool (4.37). No significant differences in evaluations were found between health care professionals and students and the general public, suggesting broad accessibility and appeal.

CONCLUSIONS: We developed a low-cost serious game that simulates NICU experiences through collaboration between a neonatologist and students. The game received positive feedback and demonstrated educational value for a diverse audience. Positioned as formative research, this study highlights the potential of serious games to supplement neonatal care education. Future updates will incorporate user feedback, leading to improvements in gameplay and expanded content.

PMID:40532200 | DOI:10.2196/73009

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Nevin Manimala Statistics

Role of Brain Age Gap as a Mediator in the Relationship Between Cognitive Impairment Risk Factors and Cognition

Neurology. 2025 Jul 22;105(2):e213815. doi: 10.1212/WNL.0000000000213815. Epub 2025 Jun 18.

ABSTRACT

BACKGROUND AND OBJECTIVES: Cerebrovascular disease (CeVD) and cognitive impairment risk factors contribute to cognitive decline, but the role of brain age gap (BAG) in mediating this relationship remains unclear, especially in Southeast Asian populations. This study investigated the influence of cognitive impairment risk factors on cognition and examined how BAG mediates this relationship, particularly in individuals with varying CeVD burden.

METHODS: This cross-sectional study analyzed Singaporean community and memory clinic participants. Cognitive impairment risk factors were assessed using the Cognitive Impairment Scoring System (CISS), encompassing 11 sociodemographic and vascular factors. Cognition was assessed through a neuropsychological battery, evaluating global cognition and 6 cognitive domains: executive function, attention, memory, language, visuomotor speed, and visuoconstruction. Brain age was derived from structural MRI features using ensemble machine learning model. Propensity score matching balanced risk profiles between model training and the remaining sample. Structural equation modeling examined the mediation effect of BAG on CISS-cognition relationship, stratified by CeVD burden (high: CeVD+, low: CeVD-).

RESULTS: The study included 1,437 individuals without dementia, with 646 in the matched sample (mean age 66.4 ± 6.0 years, 47% female, 60% with no cognitive impairment). Higher CISS was consistently associated with poorer cognitive performance across all domains, with the strongest negative associations in visuomotor speed (β = -2.70, p < 0.001) and visuoconstruction (β = -3.02, p < 0.001). Among the CeVD+ group, BAG significantly mediated the relationship between CISS and global cognition (proportion mediated: 19.95%, p = 0.01), with the strongest mediation effects in executive function (34.1%, p = 0.03) and language (26.6%, p = 0.008). BAG also mediated the relationship between CISS and memory (21.1%) and visuoconstruction (14.4%) in the CeVD+ group, but these effects diminished after statistical adjustments.

DISCUSSION: Our findings suggest that BAG is a key intermediary linking cognitive impairment risk factors to cognitive function, particularly in individuals with high CeVD burden. This mediation effect is domain-specific, with executive function, language, and visuoconstruction being the most vulnerable to accelerated brain aging. Limitations of this study include the cross-sectional design, limiting causal inference, and the focus on Southeast Asian populations, limiting generalizability. Future longitudinal studies should verify these relationships and explore additional factors not captured in our model.

PMID:40532185 | DOI:10.1212/WNL.0000000000213815

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Nevin Manimala Statistics

Development and optimization of cilostazol loaded transethosomal gel for improved performance

Pharm Dev Technol. 2025 Jun 18:1-28. doi: 10.1080/10837450.2025.2521055. Online ahead of print.

ABSTRACT

Deep vein thrombosis (DVT) is the third major leading cause of mortality and morbidity after cardiovascular disease and stroke. Cilostazol (CLZ) being one of the antiplatelet agents is effectively used in DVT. However, its oral administration is associated with several problems, such as gastrointestinal side effects and extensive first-pass metabolism. Herein, CLZ-loaded transethosomes (CLZ-TEs) were prepared and incorporated in chitosan gel (CLZ-TEG) for transdermal administration. Box-Behnken Design Expert® software was used to statistically optimize CLZ-TEs. Particle properties, Transmission electron microscopy (TEM) and Fourier Transform Infrared spectroscopy (FTIR) analyses of CLZ-TEs were accomplished followed by in vitro release and permeation studies and its comparison with CLZ-TEG, CLZ-dispersion (Ds) and CLZ-G. Moreover, skin irritation and pharmacokinetics studies of the optimized CLZ-TEG were executed. The optimized CLZ-TEs showed a mean particle size of 174 nm, polydispersity index of 0.173, zeta potential of -30 mV and entrapment efficiency of 99%. TEM exhibited spherical nanovesicles and FTIR demonstrated compatibility of the excipients. Moreover, CLZ-TEG was homogeneous, smooth, and spreadable. Similarly, CLZ-TEG displayed sustained release and enhanced permeation of the CLZ. Furthermore, pharmacokinetic study showed significantly improved (p < 0.05) bioavailability of CLZ-TEG when compared with CLZ-G and CLZ-Ds. It was concluded that CLZ-TEG may be a potential candidate for the management of DVT.

PMID:40532176 | DOI:10.1080/10837450.2025.2521055

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Nevin Manimala Statistics

Effectiveness of Participatory Ergonomic Interventions on Work-Related Musculoskeletal Disorders, Sick Absenteeism, and Work Performance Among Nurses: Systematic Review

JMIR Hum Factors. 2025 Jun 18;12:e68522. doi: 10.2196/68522.

ABSTRACT

BACKGROUND: Nurses face a higher risk of developing work-related musculoskeletal disorders (WMSDs) due to their primary roles in patient care. Participatory ergonomics (PE), an approach that integrates large-scale interventions performed at organizational and systems levels with small-scale interventions, is widely considered a promising approach to mitigate health problems at the workplace. However, its effectiveness in addressing WMSDs and secondary outcomes such as sickness absence and work performance among nurses is not fully understood.

OBJECTIVE: This systematic review assessed the effectiveness of PE interventions in preventing WMSDs and mitigating two related outcomes, sickness absence and work performance, among nurses.

METHODS: A literature search was performed in four electronic databases, PubMed, ScienceDirect, Scopus, and PsycNet, guided by the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analysis) guidelines to retrieve relevant papers published between 2017 and 2023. Papers fulfilling the eligibility criteria were analyzed and subjected to quality appraisal.

RESULTS: Overall, 19 papers were included in the final analysis. Various categories of ergonomic interventions were identified, with the predominant being exercise and physical activities, health promotional activities and training, educational programs, and patient handling devices. Multicomponent interventions, especially those involving physical activities and exercise, demonstrated stronger effects in reducing the risk of WMSDs at 6 months (OR 1.64, 95% CI 1.12-4.54) and 12 months postintervention (OR 2.70, 95% CI 1.52-4.51) compared with single interventions. However, most ergonomic interventions had no statistically significant effect (P>.05) on sickness absence and work performance. More than half (n=13) of the studies demonstrated moderate to high risk of bias, reflecting the need for better quality interventions.

CONCLUSIONS: Multicomponent interventions, particularly those involving physical activities and exercise, are more effective in reducing the risk of WMSDs among nurses compared with individual interventions. However, their long-term effects in addressing WMSDs, sick absenteeism, and work performance are still unclear. These gaps could be addressed by integrating organizational factors and prevention policies into existing ergonomic interventions, thereby offering opportunities to improve psychological health, job satisfaction, and work dynamics.

PMID:40532143 | DOI:10.2196/68522

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Nevin Manimala Statistics

Baseline Distress and Effectiveness of Survivor Video Narratives on Cancer-Associated Distress in Botswana: A Pilot Study

JCO Glob Oncol. 2025 Jun;11:e2400474. doi: 10.1200/GO-24-00474. Epub 2025 Jun 18.

ABSTRACT

PURPOSE: To evaluate baseline distress among patients with breast cancer in Botswana, and assess the impact of culturally tailored peer survivor video narratives on distress and its mediators.

METHODS: We enrolled patients with stage I-IV breast cancer at Princess Marina Hospital. A Setswana-translated National Comprehensive Cancer Network distress thermometer (DT) and problem list (PL) were used for distress screening. DT score of ≥4 was considered a positive screen for moderate to high (moderate-high) distress. We analyzed independent PL factors associated with moderate-high distress using logistic regression. Participants then watched one to two videos and completed a postintervention DT/PL assessment after each video at 4 and 8 weeks. We conducted descriptive statistics to explore the impact of the videos.

RESULTS: One hundred six participants were enrolled, of whom 103 completed baseline DT and 106 completed baseline PL. Sixty-seven percent (69/103) of participants screened positive for moderate-high distress at baseline. Fear (odds ratio [OR], 11.25 [95% CI, 1.66 to 76.49]; P = .01) and appearance (OR, 4.96 [95% CI, 1.03 to 23.80]; P = .046) were PL factors significantly associated with moderate-high distress in the multivariable model. Sixty-eight and 47 participants completed postvideo assessments at approximately 4 and approximately 8 weeks, respectively. The greatest impact was observed at 8 weeks after watching two videos-29.8% of participants with moderate-high distress had no or mild distress. Similarly, there was a 29% (44%-15%; P = .005) and 17% (32%-15%; P = .03) absolute decrease from baseline to 8 weeks, in the proportion of patients who identified fear and appearance as sources of distress, respectively.

CONCLUSION: Two thirds of patients with breast cancer screened positive for moderate-high distress. Fear and appearance were sources of distress significantly associated with a positive screen. Our results show promising potential of peer survivor videos to mitigate distress and its potential mediators among patients with breast cancer.

PMID:40532135 | DOI:10.1200/GO-24-00474