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Nevin Manimala Statistics

Use of Data Mining in the Establishment of Reference Intervals for Albumin-Adjusted Calcium

Clin Endocrinol (Oxf). 2025 Jun 4. doi: 10.1111/cen.15289. Online ahead of print.

ABSTRACT

BACKGROUND: Calcium homeostasis is critical for numerous physiological functions, and while total calcium is commonly measured in clinical practice, albumin-adjusted calcium is widely used to account for protein binding, despite concerns about its accuracy and lack of standardized reference intervals. This study aims to establish a reliable reference range for albumin-adjusted calcium using real-world data from a high-volume tertiary care laboratory.

METHODS: This study analyzed data from 33,159 individuals aged 18-80 years, selected from an initial population of 106,920 patients based on specific biochemical and clinical exclusion criteria. Statistical analysis involved outlier detection, partitioning, and calculation of age-specific reference intervals using the 2.5th and 97.5th percentiles.

RESULTS: The study established age-stratified reference intervals for albumin-adjusted calcium (18-49 years: 2.17-2.55 mmol/L; 50-79 years: 2.20-2.61 mmol/L) and total calcium (18-49 years: 2.17-2.56 mmol/L; 50-79 years: 2.17-2.62 mmol/L).

CONCLUSIONS: Our study reveals that albumin-adjusted calcium reference intervals are age-dependent, with slightly higher upper limits (≈0.05 mmol/L) than traditionally used total calcium ranges, potentially reducing overdiagnosis of hypercalcemia. Further studies are needed to validate these reference intervals across different automated analyzers and diverse patient populations to ensure broader clinical applicability.

PMID:40464109 | DOI:10.1111/cen.15289

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Nevin Manimala Statistics

Correction to “An Open-Source Implementation of Tree-Based Scan Statistics”

Pharmacoepidemiol Drug Saf. 2025 Jun;34(6):e70167. doi: 10.1002/pds.70167.

NO ABSTRACT

PMID:40464089 | DOI:10.1002/pds.70167

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Nevin Manimala Statistics

Risk of Intracranial Hemorrhage With Apixaban Versus Aspirin Therapy: A Meta-Analysis of Randomized Controlled Trials

Stroke. 2025 Jun 4. doi: 10.1161/STROKEAHA.125.051088. Online ahead of print.

ABSTRACT

BACKGROUND: Oral anticoagulants are superior to antiplatelet agents for preventing cardioembolic stroke but concerns about increased risk of intracranial hemorrhage limit their use. Although rivaroxaban demonstrably increases intracranial bleeding risk compared with aspirin, the comparative risk of intracranial hemorrhage with apixaban versus aspirin remains uncertain. We aimed to clarify this risk through a meta-analysis of randomized controlled trials.

METHODS: We searched PubMed, EMBASE, Cochrane Central Register of Controlled Trials, and ClinicalTrials.gov for randomized controlled trials comparing apixaban with aspirin for ischemic stroke prevention. Studies were excluded if no intracranial hemorrhage events were reported in either arm. In the primary analysis, we used the Mantel-Haenszel method to meta-analyze the relative risk of intracranial hemorrhage with apixaban versus aspirin therapy. We conducted sensitivity analyses to examine the strength of these findings and to examine the secondary outcome of hemorrhagic stroke (which excludes epidural and subdural hematomas).

RESULTS: Three randomized controlled trials met our inclusion criteria, comprising a total of 10 626 patients and 74 incident intracranial hemorrhage events. In the pooled analysis, the relative risk of intracranial hemorrhage with apixaban versus aspirin therapy was 0.67 ([95% CI, 0.43-1.08]; P=0.10). These findings were consistent in sensitivity analyses utilizing alternative statistical estimators, in analyses limited to primary prevention trials, and in analyses utilizing the outcome of hemorrhagic stroke (relative risk, 0.72 [95% CI, 0.39-1.31]; P=0.28).

CONCLUSIONS: In randomized controlled trials evaluating ischemic stroke prevention, apixaban demonstrated a safety profile comparable-and potentially superior-to aspirin with respect to intracranial hemorrhage risk. These findings warrant a reconsideration of clinical practices that favor aspirin over apixaban, because of the concerns about intracranial hemorrhage risk.

PMID:40464082 | DOI:10.1161/STROKEAHA.125.051088

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Nevin Manimala Statistics

Induction and augmentation of labor in India: A systematic review

Int J Gynaecol Obstet. 2025 Jun 4. doi: 10.1002/ijgo.70232. Online ahead of print.

ABSTRACT

BACKGROUND: A recent publication regarding intrapartum care in low- and middle-income countries (LMICs) found that India has the one of the highest proportions of women receiving pharmacological augmentation of labor (51%-78%). National guidelines on the use of uterotonics during labor are available in India, requiring appropriate indication and monitoring for optimal maternal and fetal outcomes.

OBJECTIVES: The aim of this research was to quantify induction and augmentation of labor in India and describe the characteristics of these practices and related outcomes for women and newborns.

SEARCH STRATEGY: The following electronic databases of published studies and gray literature were searched: PubMed, MEDLINE, EMBASE, Cumulative Index to Nursing and Allied Health Literature (CINAHL), Web of Science, Global Health, African Journals Online, Global Health Library, Global Index Medicus, ProQuest Dissertations & Theses, Cochrane Central Register of Controlled Trials, EMCare, Google Scholar, JSTOR, and Snowglobe (snowball search). We also consulted gray literature in Clinicaltrials.gov, WHO Trials, Cochrane Trials, OpenGrey, and the International Clinical Trials Registry Platform. All searches were completed on October 6, 2022. Search terms relevant to the research aims were applied, with initial searches for research conducted in any LMIC.

SELECTION CRITERIA: The review included primary research articles in English on induction and augmentation of labor in any setting in India, between January 1, 2011 and October 6, 2022. Two reviewers worked independently screening titles and abstracts for relevance to the research aims using Covidence® software. Non-concordant selection was resolved by a third team member. The full texts of included references were then retrieved for review and data extraction. Studies with low quality of evidence were excluded.

DATA COLLECTION AND ANALYSIS: The data extraction grid was piloted on five full-text reports. One reviewer manually extracted data from each full text. Three categories of variables were included in that grid: study characteristics, exposure variables, and outcome variables. The quality of the evidence was assessed by one reviewer using the National Institute for Health and Care Excellence preferred tools for the corresponding study design. To synthesize and present results, we used percentages for prevalence studies, survey studies, and for descriptive sections of comparative studies. For comparative studies, associations between variables were presented using odds ratios, risk ratios, and risk differences with their 95% confidence interval (CIs) and P-values (where the latter was the only measure used to assess difference). For each quantitative outcome of the review, we compiled and interpreted results extracted from individual studies. Qualitative findings were grouped by domains of interest (settings, category of providers, induction and augmentation procedures). Meta-analysis was not possible due to the marked heterogeneity between studies.

MAIN RESULTS: This review included 59 studies and provided evidence of moderate quality that high proportions of laboring women receive induction and augmentation of labor for facility-based childbirth across Indian geographies. Included studies reported that from 2.6% to 84.3% of laboring women received induction of labor; and from 9.6% to 86.9% received augmentation of labor. The review indicated that induction and augmentation are used in home-based childbirths as well, although these account for less than 10% of deliveries in India. The review identified several practices related to induction and augmentation of labor that are non-compliant with WHO guidelines, driven by synergistic promoting factors pertaining to both health systems and communities. Studies documented relatively high rates of complications, and reported descriptions suggest that these were related to type and regimens of induction and augmentation drugs, settings, and qualifications of providers. However, statistical associations between induction and augmentation and complications were not assessed. Included studies also revealed varied and inappropriate oxytocin storage conditions across settings. Finally, this review indicated that women were generally satisfied with the care provided to them during induction and augmentation of labor.

CONCLUSIONS: This review documented high use of pharmaceuticals for the induction and augmentation of labor, including practices that are not compliant with global and Indian recommendations for safety and quality. The review also identified both provider- and community-side drivers of these practices. These findings suggest multiple interventions that can be taken at the policy, facility, and community levels to monitor and improve induction and augmentation practices at health facilities in India. This review was funded by USAID and its protocol was registered in PROSPERO (2022 CRD42022298949).

PMID:40464073 | DOI:10.1002/ijgo.70232

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Nevin Manimala Statistics

Quantitative Assessment of Mitochondrial Volumetric Transitions in Arabidopsis thaliana

Curr Protoc. 2025 Jun;5(6):e70156. doi: 10.1002/cpz1.70156.

ABSTRACT

Mitochondria in plants typically appear as discrete spherical or slightly tubular organelles, with their morphology and volume serving as indicators of metabolic state and dysfunction. Measuring changes in mitochondrial volume is relatively straightforward in organisms lacking plastids. However, in chlorophyll-rich tissues, such assessments often require purification protocols that may compromise accuracy. Here, we present protocols for the quantitative assessment of mitochondrial volume transitions in leaf mesophyll cells of Arabidopsis thaliana. The methods are simple and highly sensitive and offer a reliable approach for studying mitochondrial morphology transitions under both physiological and stress conditions. © 2025 The Author(s). Current Protocols published by Wiley Periodicals LLC. Basic Protocol 1: Leaf mesophyll treatment and mitochondrial imaging Basic Protocol 2: Leaf mesophyll mitochondrial volume assessment Basic Protocol 3: Mitochondrial volume statistics.

PMID:40464066 | DOI:10.1002/cpz1.70156

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Risk of Switch to Mania/Hypomania in Bipolar Depressive Patients Treated with Antidepressants: A Real-World Study

Health Data Sci. 2025 Jun 3;5:0209. doi: 10.34133/hds.0209. eCollection 2025.

ABSTRACT

Background: The use of antidepressants in the treatment of bipolar depression remains controversial due to concerns about their potential to induce mood polarity switches. This multinational observational study aims to examine the association between the use of antidepressants and the risk of hypomanic/manic switch among bipolar depressive patients. Methods: Four electronic health record databases (IQVIA Disease Analyzer Germany, IQVIA Disease Analyzer France, IQVIA US Hospital Charge Data Master, and Beijing Anding Hospital) and one administrative claims database (IQVIA US Open Claims) were analyzed, and the study period covered from January 2013 until December 2017. Treatment patterns of patients with bipolar depression were collected. The hazard ratio (HR) was calculated by comparing the incidence of hypomanic/manic switch in patients who received antidepressants (AD group) with that in those who did not receive any antidepressant (non-AD group) in 730 days after the date of the first diagnosis of bipolar depression. Results: The analysis included a total of 122,843 patients from the 5 databases; 60.6% of them received antidepressants for bipolar depression. Across the 5 data sources, the mean age at index date ranged from 37.50 (15.72) to 52.10 (16.22) years. After controlling potential confounders by propensity score matching, the AD group’s manic switch risk was not significantly higher than the non-AD group’s (HR 1.04 [95% CI, 0.96 to 1.13]; P = 0.989). Additionally, no statistically significant difference was observed between patients prescribed antimanic drugs and those who were not (HR 0.69 [95% CI, 0.38 to 1.25]; P = 0.535). Conclusions: This study indicated that antidepressants were widely used in clinical settings for managing bipolar depression. The use of antidepressants was not associated with the risk of mania/hypomania switch when compared to non-antidepressants treatment. Therefore, antidepressants could be considered a treatment option for bipolar depression.

PMID:40464055 | PMC:PMC12130621 | DOI:10.34133/hds.0209

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Nevin Manimala Statistics

Analysis of early surgical indications and related factors in neonatal necrotizing enterocolitis

Front Pediatr. 2025 May 20;13:1571921. doi: 10.3389/fped.2025.1571921. eCollection 2025.

ABSTRACT

OBJECTIVE: To explore early surgical indications and clinical predictive factors for neonatal necrotizing enterocolitis (NEC) to improve the prognosis of affected infants.

METHODS: A retrospective analysis was conducted on the clinical data of 146 infants diagnosed with NEC at the Affiliated Hospital of Zunyi Medical University from January 2015 to December 2020. The infants were divided into two groups: the surgical treatment group (56 cases) and the non-surgical treatment group (90 cases). Maternal perinatal conditions, general infant characteristics, clinical manifestations, comorbidities, laboratory tests, and imaging findings were statistically analyzed. Significant factors were further analyzed using multivariate logistic regression, and predictive indicators were assessed by the receiver operating characteristic (ROC) curve and Youden’s index.

RESULTS: Statistically significant differences were observed between the two groups in birth weight, gestational age, abdominal wall erythema, absent bowel sounds, lethargy, fever, peritonitis, septic shock, metabolic acidosis, neonatal acute respiratory distress syndrome, and asphyxia (P < 0.05). No significant differences were found in maternal perinatal conditions, sex, feeding method, age at onset, abdominal distention, bloody stool, vomiting, gastric retention, apnea, neonatal pneumonia, neonatal hyperbilirubinemia, sepsis, electrolyte disturbances, or respiratory failure (P > 0.05). Laboratory and imaging markers such as prealbumin, IL-6, PCT, CRP, WBC, pneumoperitoneum, bowel wall gas, and portal venous gas showed statistically significant differences (P < 0.05). Multivariate logistic regression identified peritonitis (OR = 95.635), IL-6 (OR = 1.001), and portal venous gas (OR = 22.551) as independent risk factors for early surgery in NEC (P < 0.05). ROC curve analysis revealed that IL-6 (AUC = 0.875) and PCT (AUC = 0.798) demonstrated good predictive performance for early surgical intervention. The optimal cutoff values were 476 pg/ml for IL-6 (sensitivity 80.4%, specificity 85.6%) and 1.53 ng/ml for PCT (sensitivity 83.9%, specificity 70%).

CONCLUSION: Peritonitis and portal venous gas are independent risk factors for early surgery in NEC. IL-6 and PCT are reliable predictive markers for determining the need for early surgical intervention in NEC.

PMID:40464051 | PMC:PMC12130016 | DOI:10.3389/fped.2025.1571921

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Nevin Manimala Statistics

Application of ultrasound-guided coaxial needle biopsy combined with gelatin sponge plugging in pediatric liver biopsy

Front Pediatr. 2025 May 20;13:1477711. doi: 10.3389/fped.2025.1477711. eCollection 2025.

ABSTRACT

PURPOSE: The aim of this study was to assess the performance of utilizing the coaxial technique in conjunction with gelatin sponge slurry plugging for ultrasound-guided liver biopsy in children.

METHODS: We conducted a retrospective study of children undergoing ultrasound-guided coaxial liver biopsy at our institution between March 2020 and March 2025. Participants were stratified into two intervention groups: those receiving gelatin sponge tract embolization vs. batroxobin administered through needle tract. Through comprehensive electronic medical record review, we systematically extracted and compared the following outcome measures: (a) overall complication rates, (b) hemorrhage rates.

RESULTS: This study included 48 children, with 30 allocated to the gelatin sponge group and 18 to the batroxobin group. The gelatin sponge group demonstrated 9 complications (30.0%, 9/30), consisting of 5 pain events and 4 febrile episodes, while the batroxobin group experienced 6 complications (33.3%, 6/18), including 2 hemorrhage cases, 3 pain events, and 1 febrile episode. The overall complication rates showed no statistically significant difference between groups (30.0% vs. 33.3%, P = 0.809). However, a significant divergence was observed in hemorrhage incidence, with the gelatin sponge group demonstrating superior safety (0% vs. 11.1%, P = 0.044).

CONCLUSION: Compared to batroxobin tract injection, coaxial technique in conjunction with gelatin sponge slurry plugging significantly reduced hemorrhagic complications in liver biopsies for children, demonstrating superior safety. The finding supported its adoption as the preferred hemostatic method in children undergoing percutaneous liver biopsy.

PMID:40464048 | PMC:PMC12129982 | DOI:10.3389/fped.2025.1477711

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Nevin Manimala Statistics

Differential impact of neutrophil-to-lymphocyte ratio and time-weighted NLR on mortality and survival in critically ill children: insights from a retrospective study

Front Pediatr. 2025 May 20;13:1559405. doi: 10.3389/fped.2025.1559405. eCollection 2025.

ABSTRACT

BACKGROUND: The intensive care of critically ill children is challenging due to diverse etiologies and rapid disease progression. Early identification of high-risk patients is crucial for improving outcomes. The neutrophil-to-lymphocyte ratio (NLR) has emerged as a potential biomarker reflecting the balance between innate and adaptive immune responses, with studies in adults showing its correlation with mortality and survival in intensive care settings. However, its application in pediatric intensive care units (PICU) is less explored.

OBJECTIVE: To examine the impact and predictive value of NLR on in-hospital mortality and 90-day survival rates in critically ill children using data from the Pediatric Intensive Care (PIC) database at the Children’s Hospital of Zhejiang University School of Medicine.

METHODS: This retrospective cohort study included 3,350 patients from the PIC database, with patients older than 28 days and an ICU stay of at least 48 h. Data on demographic information, ICU admission type, laboratory test results, and clinical outcomes were collected. The normal range of NLR was calculated using the percentile method. Time-weighted NLR was calculated using the trapezoidal rule to estimate the area under the curve of NLR values over time. Statistical analyses included chi-square tests, Mann-Whitney U tests, and multivariable logistic regression to assess the association between NLR and outcomes.

RESULTS: Higher time-weighted NLR levels were significantly associated with increased in-hospital mortality (OR = 1.15, 95% CI: 1.08-1.22, p < 0.001) and shorter ICU length of stay. The Kaplan-Meier survival analysis showed significantly different 90-day survival rates among NLR groups (p = 0.034). Subgroup analysis revealed the highest predictive value of time-weighted NLR in patients under 1 year old with an initial NLR less than 0.48 (AUC = 0.832).

CONCLUSION: The study confirms NLR, particularly in its time-weighted form, as a robust prognostic indicator for critically ill children. Elevated time-weighted NLR levels are associated with increased in-hospital mortality and shorter ICU stays, highlighting its potential for risk stratification and guiding clinical decisions in PICU. The dynamic nature of the time-weighted NLR provides a more accurate reflection of the patient’s inflammatory burden over time. However, the retrospective and single-center design of the study limits the generalizability of the results. Future research should address these limitations and explore the integration of NLR with other clinical and laboratory parameters to enhance prognostic accuracy in pediatric critical care settings.

PMID:40464042 | PMC:PMC12130025 | DOI:10.3389/fped.2025.1559405

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Clinical profile and outcome of pediatric heart surgeries at semi-urban tertiary care cardiac center of Gujarat, India: a 54-month single-center retrospective chart review

Front Pediatr. 2025 May 20;13:1543755. doi: 10.3389/fped.2025.1543755. eCollection 2025.

ABSTRACT

CONTEXT: The most common congenital condition, congenital heart disease (CHD), is often left untreated or doesn’t get timely attention for various reasons. Nowadays, many pediatric cardiac centers in India offer surgical management, even in semi-urban or rural areas. Our center is one of them.

AIMS: This study aims to generate regional data from the Western part of India, primarily to determine the outcome of patients who had surgical intervention at our pediatric cardiac center.

METHODS AND MATERIAL: The present study retrospectively analyzed the data of the operated pediatric patients by reviewing the charts of patients admitted to the pediatric division of the cardiac center between April 2018 and October 2022. All demographic details, anthropometry, preoperative evaluation, operative procedures, postoperative issues, outcomes, etc. were reviewed, and the collected data were entered into Microsoft Excel.

STATISTICAL ANALYSIS: Descriptive statistics were used to present demographic data. Chi-square and Fisher exact tests were applied to find an association, and a p-value of <0.05 was considered statistically significant.

RESULTS: Out of the 422 pediatric admissions during the period studied, 386 underwent cardiac surgeries. The median (Q1, Q3) age of patients in months was 12 (6, 60), and 251 (61.2%) were males. The most prevalent CHD was ventricular septal defect (VSD), accounting for 88 patients (21.6%). Out of the 386 total patients who underwent cardiac surgery, 16 (4.1%) patients experienced mortality. The most common surgeries performed were VSD closure, patent ductus arteriosus ligation, and intracardiac repair for tetralogy of Fallot (TOF).

CONCLUSIONS: Pediatric heart surgery was offered for a varied CHD with comparable mortality and morbidity with other centers.

PMID:40464041 | PMC:PMC12129920 | DOI:10.3389/fped.2025.1543755