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Nevin Manimala Statistics

Assessment of knowledge, attitude, and practice regarding reporting of adverse events due to medical devices among healthcare workers in Gujarat

Indian J Pharmacol. 2025 Nov 1;57(6):409-413. doi: 10.4103/ijp.ijp_754_24. Epub 2025 Oct 12.

ABSTRACT

OBJECTIVE: To assess the knowledge, attitude, and practice (KAP) regarding reporting adverse events due to medical devices among healthcare workers in our hospital.

MATERIALS AND METHODS: A cross-sectional, observational, and questionnaire (KAP) study was conducted among healthcare professionals working in the various departments of our hospital. Healthcare professionals from different specialties who volunteered to participate in the study were enrolled. A total of 15 questions were included: 8 based on knowledge (7 scored), 2 on attitude, and 5 on practice. Statistical analysis was performed using Microsoft Excel® worksheet, Chi-square, and unpaired t-test. P < 0.05 was considered statistically significant.

RESULTS: A total of 370 responses were received. The knowledge of healthcare workers was found to be 73.57%. The mean score (out of 7) for doctors and paramedical staff was 5.78 ± 1.21 and 3.76 ± 1.50, respectively, indicating a wide knowledge gap between them (P < 0.05). Most healthcare workers (63%) reported witnessing fewer than 5 MDAEs. The majority (37.30%) mentioned that the cause of underreporting was a lack of knowledge. Out of all healthcare workers, 85.13% responded positively and are willing to report MDAEs in future, and most of them considered it important to report MDAEs.

CONCLUSION: Despite healthcare professionals having adequate knowledge and a positive attitude toward reporting, very poor reporting of MDAEs is observed. Lack of knowledge is a significant barrier leading to underreporting, and a substantial knowledge gap among healthcare professionals is evident.

PMID:41221570 | DOI:10.4103/ijp.ijp_754_24

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Antidepressant initiation and the risk of treatment-emergent mania in children and adolescents with depression: A real-world cohort study

J Psychopharmacol. 2025 Nov 12:2698811251389541. doi: 10.1177/02698811251389541. Online ahead of print.

ABSTRACT

BACKGROUND: Whether starting antidepressants (ADs) precipitates treatment-emergent mania (TEM) in young people with major depressive disorder (MDD) is still debated. A recent nationwide cohort study found no short-term risk, but its transferability to more diverse settings is unknown.

METHODS: Using the TriNetX global electronic-health-record network, we emulated a target trial in children and adolescents aged 6-17 years with a first MDD diagnosis (2016-2024). Patients who initiated an AD within 3 months formed the exposed cohort, and those who did not served as controls. After 1:1 propensity-score matching, 105,728 participants (52,864 per group) were followed for 3 months. The primary outcome was a composite of new mania/bipolar diagnosis or lithium initiation.

RESULTS: The exposed group had a significantly higher risk of the primary composite outcome compared to the unexposed group (45 vs. 27 events; Hazard ratio = 1.64, 95% confidence interval, 1.01-2.63, p = 0.041). However, it lost statistical significance when disaggregating the composite outcome, in landmark time-split analyses, and when restricting the cohort to patients with a prior history of healthcare encounters.

CONCLUSION: In a large, multinational real-world cohort, AD initiation was associated with a non-robust increase in short-term TEM risk. The observed association appeared susceptible to unmeasured confounding factors. These results underscore the importance of careful assessment and monitoring rather than indiscriminate AD use or avoidance in this population.

PMID:41221544 | DOI:10.1177/02698811251389541

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Systematic review and meta-analysis of risk prediction models for retinopathy of prematurity in preterm infants

Biomed Rep. 2025 Oct 22;23(6):195. doi: 10.3892/br.2025.2073. eCollection 2025 Dec.

ABSTRACT

Retinopathy of prematurity (ROP) is a proliferative vascular disease affecting preterm infants with incompletely developed retinal vasculature, characterized by abnormal vascular proliferation that can lead to retinal detachment and blindness. Given its impact on neonatal visual health, developing reliable risk prediction models for ROP has become crucial for optimizing clinical screening and intervention strategies. However, existing models exhibit substantial heterogeneity in methodology, validation, and performance, limiting their generalizability across diverse clinical settings. The present study aimed to evaluate and summarize the effectiveness of existing ROP risk prediction models in preterm infants through a systematic review and meta-analysis, with the goal of providing reliable clinical screening tools based on effectiveness metrics. A systematic search was conducted across PubMed, Cochrane Library, Web of Science and Embase databases using a strategy that combined MeSH terms and free-text words to identify literature associated with risk prediction models for ROP in preterm infants. The risk of bias was assessed using the PROBAST tool. Statistical analysis involved data synthesis, heterogeneity testing, subgroup and sensitivity analyses, and publication bias assessment. A total of 492 relevant articles were retrieved; following deduplication and screening, 28 articles involving ROP risk prediction models were included. The included studies were published between 2009 and 2025, with sample sizes ranging from 90 to 22,569 participants, and a total sample size of 72,991. A total of 16 studies did not specify the validation method, five conducted external validation, two performed both internal and external validation, and five performed only internal validation. PROBAST assessment revealed that all included models had a moderate risk of bias, primarily attributed to the retrospective nature of the study design, inconsistent variable measurement and inadequate control of confounding factors. Meta-analysis showed that the pooled area under the receiver operating characteristic curve (AUC) was 0.87 (95% CI: 0.34; 0.99), indicating good discriminative ability of the models. However, significant heterogeneity was observed (I²=99.2%, P<0.05). Subgroup analysis by model type demonstrated significant heterogeneity in both traditional statistical (I²=92.2%) and machine learning models (I²=97.3%). Subgroup analysis by study region showed no significant heterogeneity in studies from South America (I²=0%), while high heterogeneity was found in studies from Asia and North America + Europe (I²=96.6 and 93.6%, respectively). This may be associated with cross-regional differences in population characteristics (such as ethnicity and disease spectra) and variations in medical standards. Funnel plot and Peters’ bias test indicated high reliability of the overall study conclusions, and the results of the sensitivity analysis were stable. However, some studies had small sample sizes and single-center designs, leading to selection bias. Additionally, multiple studies lacked model validation, and samples were limited to specific regions, failing to cover diverse healthcare settings and ethnic groups. In conclusion, current ROP risk prediction models for preterm infants exhibit good clinical application potential, with certain discriminative and predictive abilities, which can provide references for clinical screening. However, the risk of bias and insufficient validation limit their generalization ability. Future studies should expand sample sizes through prospective designs, strengthen external validation and optimize model development to improve prediction accuracy and universality, addressing the identified risks of bias and limited generalizability.

PMID:41221538 | PMC:PMC12598925 | DOI:10.3892/br.2025.2073

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The triglyceride-glucose index as a biomarker of diabetic retinopathy: a systematic review and meta-analysis

Front Med (Lausanne). 2025 Oct 27;12:1677818. doi: 10.3389/fmed.2025.1677818. eCollection 2025.

ABSTRACT

BACKGROUND: The triglyceride-glucose (TyG) index, a surrogate marker of insulin resistance, has been linked to various diabetic complications. However, its association with diabetic retinopathy (DR) remains inconsistent. We conducted a systematic review and meta-analysis to evaluate the relationship between TyG index levels and the risk of DR.

METHODS: We searched PubMed, Scopus, and Web of Science from inception to July 2025 for observational studies reporting the association between TyG index and DR in adults with type 1 or type 2 diabetes. Two reviewers independently screened studies, extracted data, and assessed risk of bias using the Agency for Healthcare Research and Quality (AHRQ) checklist and Newcastle-Ottawa Scale. Pooled odds ratios (ORs) with 95% confidence intervals (CIs) were calculated using a random-effects model. Heterogeneity was evaluated with the I2 statistic. Publication bias was assessed via funnel plots and Egger’s test. Subgroup and meta-regression analyses were conducted to explore heterogeneity.

RESULTS: Sixteen studies with a total of 33,436 participants were included. The pooled OR for the association between higher TyG index and DR was 1.89 (95% CI: 1.27-2.82) when TyG was treated as a categorical variable, and 1.57 (95% CI: 1.25-1.98) when treated as continuous. Significant heterogeneity was observed (I 2 > 87%). Subgroup analyses revealed stronger associations in studies with smaller sample sizes and higher male proportions. Meta-regression showed that male proportion accounted for 48.71% of the heterogeneity. In categorical analyses, funnel-plot asymmetry and Egger’s test indicated small-study effects; after trim-and-fill adjustment the pooled effect attenuated and was no longer significant, suggesting sensitivity to publication bias.

CONCLUSIONS: While higher TyG levels correlate with DR-particularly when modeled continuously-the signal is heterogeneity- and bias-sensitive in categorical analyses. Our moderator analyses newly indicate a sex-composition effect, and the current lack of harmonized clinical TyG thresholds limits immediate translation.

PMID:41221513 | PMC:PMC12597932 | DOI:10.3389/fmed.2025.1677818

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Associations between fetal biometric para-meters and maternal characteristics in the prenatal screening phase for aneuploidies

Med Pharm Rep. 2025 Oct;98(4):475-485. doi: 10.15386/mpr-2933. Epub 2024 Oct 30.

ABSTRACT

BACKGROUND AND AIM: Aneuploidies are rare diseases with great impact on an individual’s life, as well as on their families, the reason why prenatal screening is performed, allowing families to take an informed decision. Initial prenatal screening includes the double test, triple test, non-invasive prenatal testing and ultrasonography. Among these, ultrasonography plays an important role giving information regarding an elevated risk for aneuploidies.

METHODS: Eighty-four pregnant women who underwent prenatal screening were included in this study, of whom 9 cases were diagnosed with an aneuploidy. A statistical analysis was performed to identify possible associations between morpho-fetal characteristics, estimated fetal growth, and other parameters, such as maternal characteristics or gestational age.

RESULTS: As expected, based on the data available in the literature, an advanced maternal age was observed in the high-risk group, compared to the low-risk one (the risk was evaluated after the initial screening and influenced the decision of a further amniocentesis). A good correlation was observed in this study between the fetal biometric parameters and gestational age, as well as between fetal biometric parameters and maternal weight gain in healthy pregnancies, while low or no correlations were found in the aneuploid pregnancies.

CONCLUSIONS: The results of our study highlight the importance of ultrasonography evaluation and reveal possible correlations of fetal parameters with maternal characteristics. These findings, together with already well-established parameters, might suggest stronger clusters of soft markers and bring supplementary information regarding the risk level of pregnancy, in order to perform a better assessment of cases where invasive diagnosis is required.

PMID:41221453 | PMC:PMC12600065 | DOI:10.15386/mpr-2933

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Nevin Manimala Statistics

Bigger challenges, similar outcomes: Robotic prostatectomy in the obese patient

BJUI Compass. 2025 Nov 9;6(11):e70112. doi: 10.1002/bco2.70112. eCollection 2025 Nov.

ABSTRACT

OBJECTIVES: The study aims to review the safety of performing robotic-assisted radical prostatectomy (RARP) in patients with a body mass index (BMI) > 35 kg/m2 in a high-volume robotic centre.

MATERIALS AND METHODS: A prospective database of all patients who underwent RARP between December 2015 and October 2024 was reviewed. Propensity score matching was done preoperatively on age, prostate-specific antigen, ISUP grade and T stage. Matched cohort analysis was conducted comparing outcomes in 89 patients with BMI ≥ 35 kg/m2 and those with BMI 18-25 kg/m2. Outcomes included operational time, estimated blood loss (EBL), positive surgical margins (PSM), complications, length of stay, continence and erectile function at 12 months.

RESULTS: Console time was significantly longer in the high-BMI group (146 ± 48 min vs. 129 ± 44 min, p = 0.02). EBL was also greater (median 350 ml vs. 200 ml, p < 0.001). However, there was no significant difference in hospital stay (median 3 days for both groups, p = 0.86), nerve sparing rates or PSM. Patients in the obese cohort experienced more complications although this was not statistically significant. At 12 months post-operatively, continence was comparable between the groups. Median pad use was 1/day (interquartile range [IQR] 0-2) in the obese cohort versus 0/day (IQR 0-1) in the non-obese cohort (p = 0.09). Pad-free status was achieved in 48.3% compared with 61.8% respectively (p = 0.06). Erectile function recovery found 14.8% regaining function in the obese cohort compared with 18.0% in the non-obese cohort (p = 0.82).

CONCLUSION: This matched cohort analysis demonstrates that obese patients undergoing RARP experience longer operative times and increased EBL. These factors do not adversely impact functional or oncological outcomes. The incidence of post-operative complications remained low and comparable with patients with a normal BMI. With appropriate surgical expertise, high BMI alone should not be considered a contraindication to RARP.

PMID:41221431 | PMC:PMC12597973 | DOI:10.1002/bco2.70112

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Outcomes of Vision Therapy on Visual Skills and Oculomotor Functions in Children with Autism Spectrum Disorder: A Prospective Study

Clin Optom (Auckl). 2025 Nov 6;17:341-351. doi: 10.2147/OPTO.S551647. eCollection 2025.

ABSTRACT

PURPOSE: Visual skills and Oculomotor function deficits are common in children with Autism Spectrum Disorder (ASD), potentially affecting their development and quality of life. This study aimed to evaluate the effectiveness of vision therapy in visual perceptual skills and oculomotor function in children with ASD.

PATIENTS AND METHODS: This prospective interventional study was conducted using a convenience sampling method between February and May 2025. All children with a prior diagnosis of ASD who met the inclusion criteria were included in the study and underwent 45 sessions of vision therapy guided by the Developmental, Individual-Differences, Relationship-Based (DIR) model. Visual skills and oculomotor functions were assessed before and after vision therapy using the Wachs Analysis of Cognitive Structures (WACS) and the Northeastern State University College of Optometry (NSUCO) Oculomotor test, respectively. The paired t-test with Hedge’s g effect size was used to compare pre and post vision therapy outcomes for normally distributed data, while the Wilcoxon signed-rank test with effect size r was applied for non-normally distributed variables. Analysis of Covariance was used to examine the effect of ASD severity on post-therapy outcomes while controlling for age and gender.

RESULTS: Among the 42 children with ASD enrolled in the study, 36 completed all 45 sessions of vision therapy. Significant post-therapy improvements with large effect size were observed in visual perceptual skills (WACS) and oculomotor functions (NSUCO). Children with mild to moderate ASD showed greater improvements than those with severe ASD. Analysis of covariance revealed a significant effect of ASD severity on post-therapy outcomes: WACS (F(1,32) = 36.80, p < 0.001, R2 = 0.55), saccades (F(1,32) = 36.75, p < 0.001, R2 = 0.54), and pursuits (F(1,32) = 35.54, p < 0.001, R2 = 0.54). Age and gender showed no statistically significant effects on the outcomes.

CONCLUSION: This prospective study provides preliminary evidence that DIR-guided vision therapy, particularly when combined with occupational and behavioral therapy, may enhance visual perceptual and oculomotor functions in children with ASD. However, randomized controlled studies with longer follow-up are needed to confirm these results.

PMID:41221430 | PMC:PMC12599212 | DOI:10.2147/OPTO.S551647

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Prevalence and Correlates of Hyperglycemia Among People Living With HIV and TB on Dolutegravir-Based Antiretroviral Therapy in Zimbabwe: A Cross-Sectional Study

Health Sci Rep. 2025 Nov 9;8(11):e71480. doi: 10.1002/hsr2.71480. eCollection 2025 Nov.

ABSTRACT

BACKGROUND AND AIMS: In low- and middle-income countries, dolutegravir-based antiretroviral therapy regimens are the preferred first-line treatment for adults, adolescents, and children with human immunodeficiency virus (HIV). Dolutegravir exhibits a higher genetic barrier to resistance, improved tolerability, and reduced potential for drug-drug interactions. However, emerging reports suggest a possible association between dolutegravir usage and hyperglycemia. Therefore, this study aims to investigate the hyperglycemia risk in dolutegravir-based antiretroviral therapy among people living with HIV and tuberculosis (TB) in Zimbabwe.

METHODS: An analytical cross-sectional study was conducted on 162 participants aged 18 and older, recruited from April to July 2024 in Harare, Zimbabwe. Participants were divided into three groups based on their HIV and TB status and dolutegravir dosage. Participants’ glycated hemoglobin levels were analyzed to determine the hyperglycaemic risk. A questionnaire was also administered to assess the risk factors associated with hyperglycemia. The R statistical software (version 4.3.2, Vienna, Austria) was used for data analysis. A p-value of < 0.05 was considered to be statistically significant.

RESULTS: The median (interquartile range) ages for these sub-groups were 44 [36-56], 44 (29.3-54.8), and 45 [35-56] years, respectively, and the age range was 20-80 years. The group taking 100 mg of dolutegravir had a 40% prevalence of impaired glucose regulation, and a hyperglycemia prevalence of 31%. In the multivariable logistic regression analysis, taking 100 mg of dolutegravir was associated with a 5.17 (95% Confidence Interval: 1.21-27.82) fold risk of developing hyperglycemia.

CONCLUSION: The study findings indicate that the prevalence of hyperglycemia and impaired glucose regulation is high in patients taking dolutegravir-based antiretroviral therapy in Zimbabwe. People living with both HIV and TB taking a double dose of dolutegravir are at a higher risk of hyperglycemia and impaired glucose regulation than those taking lower doses. This emphasizes the necessity for clinical and public health interventions to mitigate this emerging hyperglycaemic risk.

PMID:41221425 | PMC:PMC12598190 | DOI:10.1002/hsr2.71480

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Prevalence and Associated Factors of Birth Injuries Among Neonates in Ethiopia: A Systematic Review and Meta-Analysis

Health Sci Rep. 2025 Nov 9;8(11):e71479. doi: 10.1002/hsr2.71479. eCollection 2025 Nov.

ABSTRACT

INTRODUCTION AND AIMS: Birth injuries contribute to neonatal morbidity and mortality. The incidence rates of birth injuries vary from 1.9 to 53 per 1000 live births. This systematic review and meta-analysis aimed to estimate the pooled prevalence of birth injuries in Ethiopian neonates and to identify key associated risk factors. The study addresses inconsistencies in previous prevalence estimates and fills knowledge gaps regarding important contributing factors that were insufficiently explored in earlier reviews.

METHODS: The study explored various databases to access articles about the prevalence and associated factors of birth injuries among newborns, which are pertinent only to Ethiopia. The Joanna Briggs Institute quality assessment tool was utilized to evaluate the quality of each study. Data analysis was conducted using Microsoft Excel and STATA 17.0 statistical software. A random effects model was employed to estimate the pooled prevalence of birth injuries. Additionally, the Cochrane Q-test statistics and the I² test were applied. Publication bias was assessed using funnel plots and Egger’s statistical tests. Sensitivity analysis was also performed to detect the effects of smaller studies.

RESULT: Six studies involving a total population of 3781 participants were included in the analysis. The pooled prevalence of birth injuries among newborns in Ethiopia was found to be 16.24% (95% CI: 13.34-19.14; I² = 82.67%; p < 0.001). Birth weight greater than 4 kg (adjusted odds ratio [AOR] = 8.88; 95% CI: 1.79-15.98), prolonged labor (AOR = 4.70; 95% CI: 1.90-7.49), vacuum-assisted birth (AOR = 14.92; 95% CI: 6.26 to 36.10), and forceps-assisted birth (AOR = 7.83; 95% CI: 4.71-10.95) were significant predictors.

CONCLUSION AND RECOMMENDATION: The prevalence of birth injuries is notably high. The identified predictors were preventable. Implementation of routine labor and delivery practice audits and enhancing the skills of healthcare providers are recommended to reduce the risk of birth injuries.

PMID:41221423 | PMC:PMC12598101 | DOI:10.1002/hsr2.71479

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Omega-3 Long Chain Polyunsaturated Fatty Acid Supplementation for Prevention of Retinopathy of Prematurity in Pre-Term Low Birth Weight Infants: A Pilot Study

Health Sci Rep. 2025 Nov 9;8(11):e71490. doi: 10.1002/hsr2.71490. eCollection 2025 Nov.

ABSTRACT

BACKGROUND AND AIMS: Retinopathy of prematurity (ROP) is a vasoproliferative disorder of the retina affecting preterm infants that potentially leads to blindness. Omega-3 long-chain polyunsaturated fatty acids (LCPUFA) have anti-inflammatory and antiangiogenic effects, thereby reducing pathological neovascularization and preventing the incidence of ROP. This study was done to evaluate the effect of available omega-3 LCPUFA supplementation for the prevention of ROP among Bangladeshi infants.

METHODS: This pilot study was conducted in the Neonatology Department of a tertiary care hospital in Bangladesh from November 2022 to March 2024 among preterm neonates < 34 weeks of gestation with birth weight < 1800 g. Initially, 76 preterm neonates were enrolled in this study. Among them, 71 preterm neonates were randomly allocated to the intervention group and the control group. The intervention group received a cap. omega-3 LCPUFA enterally (40 mg/kg/day). It was added to their enteral feeds within 48 h of the first enteral feed and continued from the starting point to 4 weeks. The control group received no supplementation.

RESULTS: The incidence of ROP was almost similar between the omega-3 LCPUFA group and the control group (37.1% in the intervention group vs. 41.6% in the control group, p = 0.69). However, severe ROP incidence was significantly reduced in the omega-3 group. Three patients developed severe ROP in the omega-3 LCPUFA group, in contrast to nine patients in the control group (23.1% vs. 60%, p = 0.049). On logistic regression analysis, while considering risk factors for ROP, omega-3 LCPUFA supplementation was not found to have a significant association with the incidence of ROP.

CONCLUSION: Omega-3 LCPUFA supplementation does not reduce the overall incidence of ROP; however, it may lower the risk of severe ROP. This reduction in severe ROP cases may help decrease the need for invasive treatments and improve long-term visual outcomes in preterm infants. Nonetheless, the study lacks sufficient statistical power to confirm this conclusively.

PMID:41221421 | PMC:PMC12598100 | DOI:10.1002/hsr2.71490