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Nevin Manimala Statistics

Early menarche and current nutritional status of the adolescents from a birth cohort

Rev Bras Ginecol Obstet. 2025 Jul 15;47:e-rbgo28. doi: 10.61622/rbgo/2025rbgo28. eCollection 2025.

ABSTRACT

OBJECTIVE: To assess the association between early menarche and the nutritional status of the adolescents from the RPS – Brazilian Birth Cohorts Consortium (Ribeirão Preto, Pelotas and São Luís) birth cohort in São Luís, Maranhão.

METHODS: A longitudinal study with data from the first and third follow-up of the cohort was conducted. A total of 1,225 adolescents aged 18 to 19 years were surveyed and analyzed for age at menarche, defined as early if <12 years old, and for the variable body mass index (BMI) for age, classified into z-scores by sex, as underweight (z-score <-2), adequate weight (z-score ≥-2 and ≤+1), and excess weight (z-score >+1). Directed acyclic graphs were constructed using the DAGitty® program to select confounding variables for adjustment. Multinomial logistic regression adjusted for confounding variables such as parental obesity (yes or no), skin color (white or non-white), and birth weight (low birth weight, adequate birth weight, and high birth weight) was used to assess the association between early menarche and nutritional status. Statistical analyses were performed using STATA 15.0 software.

RESULTS: Out of the 1,225 adolescents investigated, 32.6% experienced early menarche, and the majority had a BMI appropriate for their age (75.2%). Among adolescents with early menarche, 28.3% were classified as excess weight for their age. Multinomial logistic regression revealed an association between early menarche and excess weight (OR = 1.80; 95% CI = 1.21-2.69; p-value = 0.004).

CONCLUSION: Thus, the results indicate an association between the occurrence of early menarche and excess weight in the investigated adolescents.

PMID:40673021 | PMC:PMC12266849 | DOI:10.61622/rbgo/2025rbgo28

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Low-dose exposure to tranexamic acid has no significant toxic effect on human cartilage

Knee. 2025 Jul 15;56:479-487. doi: 10.1016/j.knee.2025.06.019. Online ahead of print.

ABSTRACT

BACKGROUND: Recent studies have raised concerns about the potential cytotoxic effects of tranexamic acid (TXA) on cartilage. This study aimed to evaluate the safety of low-dose TXA exposure on human cartilage.

METHOD: In this ex-vivo study, 30 patients with a varus osteoarthritic knee undergoing total knee arthroplasty (TKA) were enrolled. During the surgery, a set of six osteochondral plugs was harvested from the apparently intact lateral condyle of each patient’s femur, resulting in a total of 180 plugs. Subsequently, all three plugs of each set were randomly exposed to one of the TXA treatment groups: 1 mg/ml (TI group), 5 mg/ml (TV group), or 10 mg/ml (TX group) of TXA. The remaining three plugs of each set were assigned to the control group and exposed to 0.9 % saline as a match for comparison. The effects of TXA dose and exposure time on cell viability were assessed using acridine orange/propidium iodide staining at baseline, 3, and 6 h post-exposure.

RESULTS: Cell viability decreased over time in the TI, TV, TX, and control groups compared with their baselines (P = 0.006, P < 0.001, P = 0.001, P < 0.001, respectively). However, the differences in the trend of decline were not statistically significant between groups (P = 0.3), and direct comparisons among TXA concentrations and saline control at baseline, 3, and 6 h after exposure showed no statistically significant difference in cell death (P = 0.538, P = 0.256, P = 0.287, respectively).

CONCLUSIONS: Exposure to low-dose TXA (≤10 mg/ml) for up to 6 h did not cause significant toxic effects on human cartilage.

PMID:40669096 | DOI:10.1016/j.knee.2025.06.019

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Prognostic impact and clinical management of pT4N0 colon cancer: data from a large, multicenter, international, real-world dataset

ESMO Open. 2025 Jul 15;10(8):105496. doi: 10.1016/j.esmoop.2025.105496. Online ahead of print.

ABSTRACT

BACKGROUND: T4 is one of the most important prognostic factors in localized colon cancer (CC), especially in stage II (pT4N0). However, the optimal adjuvant treatment in this subset of patients remains unclear. We present a large, multicenter, international, real-world analysis of pT4N0 CC patients.

PATIENTS AND METHODS: A real-world database regarding clinicopathological characteristics of patients with stage II pT4N0 CC surgically removed between 2010 and 2021 was queried. Primary endpoints were overall survival (OS) and relapse-free survival (RFS), and analyses were adjusted on age (with a cut-off of 75 years) to reduce selection bias.

RESULTS: Our study included 492 patients; outcomes data were available for 390 patients. Median age was 73 years. Microsatellite status was assessed in 294 (75%), including 74 (25%) mismatch repair deficient (dMMR)/microsatellite instability (MSI). Adjuvant chemotherapy was prescribed in 204 patients (52%), mostly oxaliplatin-based (70%). After a median follow-up of 46.8 months, 6 months of adjuvant chemotherapy was associated with a significant improvement in OS [hazard ratio (HR) age-adjusted 0.22, P < 0.001] when compared with no adjuvant. The benefit was seen also with 3 months of adjuvant chemotherapy, even if the benefit was lower (HR age-adjusted 0.60, P < 0.001). Similar results were observed in terms of RFS, with a statistically significant benefit both in the 6-month group (HR age-adjusted 0.47, P = 0.001) and in the 3-month group (HR age-adjusted 0.71, P = 0.001). Considering the regimen and the duration of treatment, 6 months of oxaliplatin-based chemotherapy was associated with a significant improvement in both OS and RFS (P < 0.001). In univariate analysis, MMR status was not associated with OS nor RFS.

CONCLUSIONS: T4 was confirmed to be a poor prognostic factor. Adjuvant chemotherapy provided a large benefit, with a significant reduction in risk of recurrence and death. The benefit was proportional to its duration, and oxaliplatin-based chemotherapy may be better than monotherapy.

PMID:40669095 | DOI:10.1016/j.esmoop.2025.105496

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Feasibility of Digitally Identifying and Minimizing Stressors in Palliative Care Workplaces by Measuring Stress Continuously for Nurses Through Wearable Sensors (DiPa): Protocol for a Prospective Cross-Sectional Study

JMIR Res Protoc. 2025 Jul 16;14:e63549. doi: 10.2196/63549.

ABSTRACT

BACKGROUND: Nursing in palliative medicine combines primary patient care with the special challenges of this medical field (eg, handling the processes of dying, grief, and death). These cause high stress levels and burden on the nursing staff, resulting in an early exit from working life because of physical or psychological disorders like burnout.

OBJECTIVE: DiPa (digitally identifying and minimizing stressors in palliative care) is a prospective study investigating the feasibility of measuring burden and its causes in palliative care using methods of subjective and objective stress detection. Based on these results, stress-reducing interventions are to be deduced and evaluated. In this paper, we present our study protocol.

METHODS: The nursing staff of an inpatient university palliative hospital ward gathered data over 6 weeks. Each was equipped with a smart wristband and a smartphone that continuously measure physiological and ambient parameters throughout their working day. These objective data were enriched by subjective measurements: a questionnaire at the beginning of the study that assessed multiple potential stressful situations and constellations in the private and working environment as well as ecological momentary assessments (EMAs) during the workday. The EMAs were prompted by scanning near-field communication (NFC) tags placed at different locations on the ward. The ongoing data analyses will be processed using computer algorithms partly programmed specifically for this study and partly drawn from existing libraries, such as toolboxes for neurophysiological signal processing for Python. Comparisons between subjective and objective measures and group comparisons between variables of interest will be made using inferential statistics, including regression analyses and analyses of variance. Data analysis using machine learning algorithms will be implemented once sufficient data are gathered.

RESULTS: The study was funded in October 2019. As of July 2025, 12 of 18 nurses in the palliative care unit consented to participate in our study. We expect to start detailed data analysis in in the third quarter of 2025 and to finish and publish our results in 2026.

CONCLUSIONS: The DiPa study aims at testing the feasibility of measuring and merging subjective and objective stress parameters for palliative care nurses.

TRIAL REGISTRATION: German Register for Clinical Studies DRKS00024425; https://drks.de/search/en/trial/DRKS00024425/details.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/63549.

PMID:40669075 | DOI:10.2196/63549

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Usability and Usefulness of SMS-Based Artificial Intelligence Intervention (Mwana) on Breastfeeding Outcomes in Lagos, Nigeria: Pilot App Development Study

JMIR Form Res. 2025 Jul 16;9:e65157. doi: 10.2196/65157.

ABSTRACT

BACKGROUND: Nigeria has one of the highest child mortality rates globally, with 111 deaths per 1000 live births. Exclusive breastfeeding (EBF) improves infant survival by providing essential nutrients and antibodies that protect against infections and diseases. Despite its benefits, EBF rates in Nigeria remain low at 29%, largely due to limited health care support and breastfeeding guidance. With the proliferation of mobile phones in Nigeria, mobile health (mHealth) interventions are being explored as scalable solutions. SMS text messaging interventions have demonstrated success in delivering behavioral interventions; yet, few use artificial intelligence (AI) for personalized breastfeeding support.

OBJECTIVE: This study evaluates the effectiveness of Mwana, an AI-powered SMS-based app, in improving breastfeeding outcomes for postpartum mothers in Lagos, Nigeria.

METHODS: Mwana was developed using TextIt for SMS integration and Meta’s Wit.ai for natural language processing (NLP). The chatbot provides breastfeeding support via SMS, offering personalized tips, addressing common challenges, and connecting users to human agents when necessary. The intervention was piloted with 216 postpartum mothers recruited through local health care networks, focusing on usability, usefulness, and engagement. The study used a mixed methods approach, using structured surveys and observation to assess participant experiences at multiple intervals over a 6-month period. Primary outcomes measured were app usability, usefulness, and breastfeeding adherence.

RESULTS: The intervention was well-received, with high scores for both usefulness (mean 4.01, SD 1.41) and usability (mean 3.92, SD 1.35) on a 5-point scale. The majority of respondents, 57% (118/206), rated the chatbot’s usefulness at the highest score of 5. Qualitative feedback statements identified areas for improvement, including enhancing AI comprehension, response times, and human-like interaction.

CONCLUSIONS: The study highlights the potential of Mwana to improve breastfeeding outcomes in resource-limited settings, contributing to the growing body of evidence supporting mHealth interventions in maternal and child health. By leveraging personalized messaging, SMS-based delivery, and language localization, Mwana offers a scalable, accessible solution. However, challenges remain regarding AI comprehension, and further research is necessary to evaluate Mwana’s effectiveness among populations not actively engaged with health care services. Future iterations will expand AI training datasets, refine NLP capabilities, and scale to broader populations.

PMID:40669071 | DOI:10.2196/65157

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Exploring the Immediate and Long-Term Effects of Immersive Virtual Reality on Behavioral and Psychological Symptoms of Dementia and Caregiver Burden: Longitudinal Observational Study

JMIR Serious Games. 2025 Jul 16;13:e73044. doi: 10.2196/73044.

ABSTRACT

BACKGROUND: Virtual reality (VR) interventions are emerging as promising nonpharmacological strategies for people with dementia, aiming to prevent cognitive decline, reduce behavioral and psychological symptoms of dementia (BPSD), and alleviate caregiver burden. Although some studies have reported beneficial effects, findings remain inconsistent, and little is known about the duration and sustainability of these effects, particularly in real-world care settings.

OBJECTIVE: This study aimed to examine both the immediate and long-term effects of an immersive VR reminiscence intervention on BPSD and caregiver burden in people with dementia attending day care centers.

METHODS: This longitudinal observational study was conducted in 10 dementia day care centers in Kaohsiung, Taiwan. A total of 82 participants with dementia were enrolled. The VR intervention consisted of twice-weekly sessions over one month, featuring culturally familiar live-action 360° scenes filmed in well-known Taiwanese locations. Each session lasted approximately 10-12 minutes and included interactive elements. Neuropsychiatric symptoms were assessed using the Neuropsychiatric Inventory Questionnaire, and caregiver burden was assessed using the Zarit Caregiver Burden Interview. Measurements were taken at 3 time points: preintervention, immediately postintervention, and 2 months after the intervention ended. The Wilcoxon signed-rank test was used for statistical comparisons, and rank-biserial correlation was calculated as the effect size.

RESULTS: Significant improvements were observed after 1 month of VR intervention in both caregiver burden (Z=-3.095, P=.002, r=0.34) and neuropsychiatric symptoms (Z=-2.929, P=.003, r=0.32). At the two-month follow-up, neuropsychiatric symptoms remained significantly improved (Z=-4.327, P<.001, r=0.48), although caregiver burden returned to preintervention levels. Regarding specific neuropsychiatric symptoms, significant improvements were observed immediately after the intervention in dysphoria or depression, anxiety, and sleep or nighttime behaviors. These effects were sustained over time, with additional long-term improvements noted in euphoria or elation, apathy or indifference, irritability or lability, aberrant motor behavior, and appetite or eating behaviors.

CONCLUSIONS: A 1-month immersive VR reminiscence intervention appears to improve neuropsychiatric symptoms and temporarily reduce caregiver burden in people with dementia, with some symptom improvements lasting up to 2 months. These findings suggest that VR may offer a meaningful therapeutic option in day care settings. Future studies with control groups, including nonimmersive 2D conditions, and comparisons to traditional reminiscence therapy are needed to validate and expand upon these findings.

PMID:40669069 | DOI:10.2196/73044

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Factors Influencing Health Workers’ Acceptance of Guideline-Based Clinical Decision Support Systems for Preventive Services in Thailand: Questionnaire-Based Study

JMIR Hum Factors. 2025 Jul 16;12:e57314. doi: 10.2196/57314.

ABSTRACT

BACKGROUND: A guideline-based clinical decision support system (CDSS) is a knowledge-based system designed to collect crucial data from electronic medical records to generate decision-making based on system data requirements and inputs from standard guidelines. Despite the potential to enhance health care delivery, the adoption rate of CDSSs in clinical practice remains suboptimal.

OBJECTIVE: This study aimed to evaluate the determinants influencing the intention to use a new CDSS in preventive care within clinical practice.

METHODS: A single-center, questionnaire-based, cross-sectional study was conducted among physicians and medical students responsible for providing comprehensive preventive services at the Continuity of Care Clinic, Siriraj Hospital, Thailand.

RESULTS: In total, 89 participants were enrolled. Relationships between factors impacting the adoption of CDSSs were analyzed using correlation and regression analysis. We found that physicians’ intentions to adopt the CDSS for preventive care were high, with 79% (70/89) of participants expressing their intention to use the system. According to the study’s conceptual framework, modified from the original unified theory of acceptance and use of technology model, physicians’ positive attitudes toward CDSS use in preventive services and a high level of effort expectancy emerged as crucial factors influencing the intention to use the new CDSS. The odds ratios for these factors were 5.44 (95% CI 1.62-18.34, P=.006) and 7.60 (95% CI 1.55-31.37, P=.01), respectively. Similar results were observed for medical students and for physicians who had graduated. The most prevalent barriers to CDSS implementation were related to physicians’ attitudes, followed by issues such as the accuracy and burden of data input, time constraints for clinicians, and the risk of workflow disruption.

CONCLUSIONS: There was a high intention to adopt the CDSS in preventive care. Positive physician attitudes toward CDSS use in preventive services and effort expectancy were found to be critical factors influencing the intention to use the new CDSS.

PMID:40669060 | DOI:10.2196/57314

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Facilitated Telemedicine as a Patient-Centered, Sociotechnical Intervention to Integrate Hepatitis C Treatment Into Opioid Treatment Programs and Overcome the Digital Divide Among Underserved Populations: Qualitative Study

JMIR Public Health Surveill. 2025 Jul 16;11:e68854. doi: 10.2196/68854.

ABSTRACT

BACKGROUND: People with opioid use disorder (OUD) have the highest rates of hepatitis C virus (HCV) infection. Despite the availability of curative HCV medication, people with OUD have limited health care access largely due to stigma. In a recent, pragmatic, randomized controlled trial (RCT), we compared a facilitated telemedicine intervention for HCV treatment integrated into opioid treatment programs (OTPs) with off-site referral. Facilitated telemedicine is bidirectional videoconferencing between a remote provider and a patient, supported by a case manager who facilitates the telemedicine encounter. The case manager schedules telemedicine visits, provides appointment reminders, and operates the digital equipment. Among 602 participants in the RCT, 90% (n=262) were cured through facilitated telemedicine and 39% (n=123) were cured through off-site referral. In this work, a multidisciplinary group of investigators, who directed the RCT, conducted a workshop, “Advancing Viral Hepatitis Screening and Treatment in Opioid Treatment Settings – Models & Resources,” at the American Association for Treatment of Opioid Dependence Conference in May 2024 to disseminate knowledge of facilitated telemedicine, including implementation considerations. We highlighted facilitated telemedicine as a patient-centered, sociotechnical, pragmatic health care delivery model for underserved populations.

OBJECTIVE: This study aimed to identify lessons learned to successfully overcome challenges of facilitated telemedicine implementation for HCV treatment integrated into OTPs.

METHODS: We partnered with the National Alliance of State and Territorial AIDS Directors in planning the workshop. The workshop consisted of 7 presentations on topics related to facilitated telemedicine implementation. The workshop was recorded and transcribed by Zoom (Zoom Communications). The transcripts served as data for the thematic analysis. The transcripts were interpreted to elucidate patterns of meanings and nuances derived from each presentation. In an iterative process, preliminary findings were compared and coalesced into themes. Verbatim quotes from the workshop were highlighted to support the themes.

RESULTS: We developed 3 themes. First, patient-centered care promotes HCV treatment for underserved populations through facilitated telemedicine. Case managers leveraged the destigmatizing environment of the OTP to build trust with patients, promoting an HCV cure through facilitated telemedicine. Second, sociotechnical approaches expand health care access for people with OUD. To be effective, facilitated telemedicine integrates 2 necessary components, a social aspect and a technical aspect. Third, facilitated telemedicine supports pragmatic research emphasizing people with OUD. Pragmatic research of facilitated telemedicine is needed to assess sustainability and scaling considerations beyond OTPs. Overall, we found that facilitated telemedicine overcame the digital divide, promoting access to digital technology, internet provision, and digital literacy.

CONCLUSIONS: Facilitated telemedicine incorporates both a technical and a social component. The technical component largely addresses geographical challenges, while the social component addresses temporal (ie, care coordination) issues, promotes trust, and largely assuages patients’ concerns related to HCV treatment. The patient-centered, sociotechnical intervention can address the digital divide, thereby increasing health care access.

PMID:40669057 | DOI:10.2196/68854

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Detection and Analysis of Circadian Biomarkers for Metabolic Syndrome Using Wearable Data: Cross-Sectional Study

JMIR Med Inform. 2025 Jul 16;13:e69328. doi: 10.2196/69328.

ABSTRACT

BACKGROUND: Wearable devices are increasingly used for monitoring health and detecting digital biomarkers related to chronic diseases such as metabolic syndrome (MetS). Although circadian rhythm disturbances are known to contribute to MetS, few studies have explored wearable-derived circadian biomarkers for MetS identification.

OBJECTIVE: This study aimed to detect and analyze sleep and circadian rhythm biomarkers associated with MetS using step count and heart rate data from wearable devices and to identify the key biomarkers using explainable artificial intelligence (XAI).

METHODS: Data were analyzed from 272 participants in the Korean Medicine Daejeon Citizen Cohort, collected between 2020 and 2023, including 88 participants with MetS and 184 without any MetS diagnostic criteria. Participants wore Fitbit Versa or Inspire 2 devices for at least 5 weekdays, providing minute-level heart rate, step count, and sleep data. A total of 26 indicators were derived, including sleep markers (midsleep time and total sleep time) and circadian rhythm markers (midline estimating statistic of rhythm, amplitude, interdaily stability, and relative amplitude). In addition, a novel circadian rhythm marker, continuous wavelet circadian rhythm energy (CCE), was proposed using continuous wavelet transform of heart rate signals. Statistical tests (t test and the Wilcoxon rank sum test) and machine learning models-Shapley Additive Explanations, explainable boosting machine, and tabular neural network-were applied to evaluate marker significance and importance.

RESULTS: Circadian rhythm markers, especially heart rate-based indicators, showed stronger associations with MetS than sleep markers. The newly proposed CCE demonstrated the highest importance for MetS identification across all XAI models, with significantly lower values observed in the MetS group (P<.001). Other heart rate-based markers, including relative amplitude and low activity period, were also identified as important contributors. Although sleep markers did not reach statistical significance, some were recognized as secondary predictors in XAI-based analyses. The CCE marker maintained a high predictive value even when adjusting for age, sex, and BMI.

CONCLUSIONS: This study identified CCE and relative amplitude of heart rate as key circadian rhythm biomarkers for MetS monitoring, demonstrating their high importance across multiple XAI models. In contrast, traditional sleep markers showed limited significance, suggesting that circadian rhythm analysis may offer additional insights into MetS beyond sleep-related indicators. These findings highlight the potential of wearable-based circadian biomarkers for improving MetS assessment and management.

PMID:40669055 | DOI:10.2196/69328

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Exergaming System for Exercise-Based Cardiac Rehabilitation in Patients With Heart Failure: Development and Usability Assessment Study of a Device Prototype

JMIR Serious Games. 2025 Jul 16;13:e71385. doi: 10.2196/71385.

ABSTRACT

BACKGROUND: Heart failure (HF) is a growing global health concern, and adherence to early cardiac rehabilitation (CR) remains suboptimal. Exergaming is a promising alternative to conventional exercise programs for patients with HF. However, existing research has limitations, and the integration of exergaming into clinical practice remains challenging. Most notably, current studies often rely on commercially available systems that are not tailored to needs specific to patients with HF, lack long-term adherence strategies, and have limited evaluation in the initial phases of cardiac rehabilitation.

OBJECTIVE: This study aimed to design, develop, and assess the usability of a novel exergaming prototype (ie, HEFMOB), integrating immersive virtual reality (VR), real-time biometric monitoring, and autonomous session management to support early-phase, exercise-based CR in patients with HF.

METHODS: A multidisciplinary team developed HEFMOB through iterative prototyping. The final system included a pedal-based VR cycling game and an upper-limb mobilization minigame, with real-time monitoring of heart rate, blood pressure, and peripheral capillary oxygen saturation. Usability was assessed in two phases: (1) an expert evaluation and refinement phase and (2) a single-session usability phase involving 10 patients with HF (4 female). The sessions were recorded and individually evaluated by 2 researchers using the Serious Game Usability Evaluator tool. After each session, the participants completed the System Usability Scale (SUS) and a subscale of Intrinsic Motivation Inventory (IMI) to rate the usability of the exergaming prototype and enjoyment, respectively. Descriptive statistics were reported.

RESULTS: The participants had a mean age of 64.8 (SD 8.4) years, BMI of 26.7 (SD 4.6) kg/m2, and left ventricular ejection fraction of 40.5% (SD 7.4%). All participants completed the session without adverse events. The SUS score averaged 71.5, SD 17.8 (indicating good usability) and IMI scores indicated very high enjoyment (mean 25.1, SD 3.5). A total of 136 gameplay-related events were recorded: negative (n=76, mostly confusion), neutral (n=49), and positive (n=11). Interface-related issues (n=61) were most common, followed by design (n=52) and hardware (n=23).

CONCLUSIONS: HEFMOB appears to be a promising, engaging, and well-tolerated tool for delivering tailored exergaming interventions in patients with HF. High usability and enjoyment ratings support its acceptability, while structured user experience analysis provided valuable insights for system refinement. This study marks a critical step toward integrating personalized, gamified exercise in inpatient settings, especially where early mobilization is lacking. Building on these findings, future research will assess long-term usability and clinical impact through a multicenter randomized controlled trial.

PMID:40669044 | DOI:10.2196/71385