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Nevin Manimala Statistics

A multicenter prospective cohort study evaluating 30-day outcomes after an emergency department visit for hyperglycemia in Canadian adults with type 1 or 2 diabetes

CJEM. 2025 Apr 25. doi: 10.1007/s43678-025-00913-6. Online ahead of print.

ABSTRACT

OBJECTIVES: Previous retrospective studies have demonstrated that patients with sub-optimally controlled diabetes have higher healthcare resource utilization in emergency department (ED) management of hyperglycemia compared to those with good glycemic control. This study’s objective was to prospectively describe 30-day outcomes including return visits and hospitalizations after an initial ED visit for hyperglycemia.

METHODS: We conducted a multicenter prospective cohort study of adults ≥ 18 years at four Ontario academic EDs diagnosed with hyperglycemia, diabetic ketoacidosis, or hyperosmolar hyperglycemic state. The primary outcome was an unplanned repeat ED visit for hyperglycemia within 30 days of index visit. We conducted telephone follow-up at 14 and 30 days to determine additional outcomes. Data were summarized using descriptive statistics.

RESULTS: There were 657 ED visits for hyperglycemia representing 594 unique patients. Mean (SD) age was 52.0 (18.2) years, 53.2% were male. Within 30 days, 96 (14.7%) had a return ED visit for hyperglycemia, 49 (7.5%) were hospitalized, and 4 (0.6%) died. We were able to contact 383 (58.3%) patients by telephone at 14 days and 275 (41.9%) at 30 days. Of these, 68.3% self-identified as Caucasian/White, while 6.3% were Indigenous. 44.9% reported an annual household income below $50,000. 29.1% of working patients took time off following their index visit.

CONCLUSION: This prospective study describes 30-day outcomes and healthcare utilization of ED patients presenting for hyperglycemia. ED clinicians should be aware of the potential for subsequent healthcare utilization and risk for readmission and intervene as appropriate to reduce adverse outcomes in patients with diabetes presenting with hyperglycemia.

PMID:40279059 | DOI:10.1007/s43678-025-00913-6

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Nevin Manimala Statistics

The effect of breathing exercises on pain, sleep, and symptom management in patients undergoing hemodialysis: a randomized controlled trial

Sleep Breath. 2025 Apr 25;29(2):170. doi: 10.1007/s11325-025-03332-0.

ABSTRACT

PURPOSE: This study was conducted to determine the effect of breathing exercises on pain, sleep, and symptom management in patients undergoing hemodialysis.

METHODS: The randomized controlled study was conducted with patients undergoing hemodialysis at a private dialysis center in the northern Black Sea region. Data were collected using the Descriptive Information Form, the Visual Analog Scale (VAS), the Richards-Campbell Sleep Questionnaire (RCSQ), the Dialysis Symptom Index (DSI), and the Vital Signs Form. According to the power analysis performed in the study, a total of 70 participants, 35 in each group, needed to be included in the study in order to conduct an independent t-test with a confidence level of 95%, a test power of 95%, and an effect size of d = 0.80. The study was conducted with a total of 69 patients divided into two groups: the experimental group (n = 35) and the control group (n = 34). Patients in the experimental group performed breathing exercises (Diaphragmatic breathing, Agni Sār, Nadi Shodhana, and the 4-7-8 breathing technique) on dialysis days for eight weeks. During this period, patients in the control group continued to receive routine nursing care in the hemodialysis unit.

RESULTS: Following the application, the average pain intensity in the control group (4.06 ± 3.1) was found to be statistically significantly higher than the average in the experimental group (0.4 ± 1.19) (p < 0.001). The average sleep score in the control group (48.56 ± 22.35) was found to be statistically significantly lower than the average in the experimental group (80.21 ± 16.46) (p < 0.001). The average DSI in the control group (92 ± 22.05) was found to be statistically significantly higher than the average in the experimental group (41.37 ± 7.15) (p < 0.001).

CONCLUSION: Breathing exercises in patients undergoing hemodialysis were found to reduce pain, improve sleep quality, and have a positive impact on symptom management. In light of this, it is recommended that nurses include breathing techniques as part of the care provided to hemodialysis patients. Using complementary methods such as breathing therapy supports the physical, psychological, psychosocial, and holistic care of patients, thus increasing patient satisfaction and quality of life. Training health professionals in breathing therapy will ensure a broader use of this complementary method in a larger patient population.

PMID:40279052 | DOI:10.1007/s11325-025-03332-0

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Nevin Manimala Statistics

Causal Variants in CHRNA1 and CHRNB1 Genes for Anti-acetylcholine Receptor Antibody Positive Myasthenia Gravis: Evidence from Bayesian Fine-Mapping and Genetic Association Study

Mol Neurobiol. 2025 Apr 25. doi: 10.1007/s12035-025-04958-7. Online ahead of print.

ABSTRACT

Autoantibodies target the acetylcholine receptor (AChR) in 85% of myasthenia gravis (MG) patients. Genomic studies highlighted the association of genes encoding AChR subunits (CHRNA1 and CHRNB1) and MG in European populations. Additionally, Mendelian randomization revealed rs4151121 at the CHRNB1 locus as a potential causal variant. Here, we performed Bayesian fine-mapping of the CHRNA1 locus using GWAS summary statistics, a linkage disequilibrium matrix and functional annotations. The GWAS lead hit rs35274388 was identified as a causal variant overlapping with the promoter region (p < 0.01). Next, we performed a candidate gene study including 1038 participants from Serbia. Rs4151121 minor allele G was associated with late-onset MG (LOMG) (OR = 1.327, 95% CI = 1.084-1.625, p = 0.006, pperm = 0.007). Carriers of the rs4151121 GG and AG genotypes had an almost 1.5-fold increased risk of developing LOMG. A borderline association of the rs35274388 minor allele A with MG was observed (OR = 1.478, 95% CI = 1.009-2.166, p = 0.044, pperm = 0.060). Individuals with AA and GA genotypes also showed a nearly 1.5-fold higher risk of developing MG. In silico-identified causal variants at the CHRNA1 and CHRNB1 loci represent risk factors for MG in European populations, and to a greater extent for LOMG. Studies on non-European populations and functional research are needed to elucidate the role of AChR genes in the genetic architecture and development of MG.

PMID:40279038 | DOI:10.1007/s12035-025-04958-7

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Nevin Manimala Statistics

Post-brachytherapy patient management: the need for integrated health information systems in radiation safety and mortality tracking

Jpn J Radiol. 2025 Apr 25. doi: 10.1007/s11604-025-01793-7. Online ahead of print.

NO ABSTRACT

PMID:40279030 | DOI:10.1007/s11604-025-01793-7

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Nevin Manimala Statistics

LDL-C Reduction with Evolocumab Among Patients with ASCVD in China: Real-World Evidence from Tianjin Metropolitan Area

Adv Ther. 2025 Apr 25. doi: 10.1007/s12325-025-03199-3. Online ahead of print.

ABSTRACT

INTRODUCTION: Clinical trials have shown that adding evolocumab to statin therapy reduces low-density lipoprotein cholesterol (LDL-C) levels by approximately 60%. Given differences in patient characteristics and standards of care between trial and real-world settings, we conducted a cohort study to evaluate the LDL-C reduction achieved with evolocumab in clinical practice of China.

METHODS: The data source was the Tianjin Regional Healthcare Database (TRHD), which includes linked electronic health records (EHR) of public hospitals serving over 15 million residents in the Tianjin metropolitan area. The study cohort included adult patients with atherosclerotic cardiovascular disease (ASCVD) who added evolocumab to their statin therapy between 2019 and 2023. Key inclusion criteria were use of the same statin intensity before and after evolocumab initiation and available LDL-C values at baseline (within 90 days before initiation) and follow-up (15-90 days after initiation). Descriptive statistics were used to analyze LDL-C change between baseline and follow-up. To provide the context for evolocumab use and for study method assessment, we included another cohort of patients with stable statin intensity (unchanged for at least 180 days)-a cohort with minimal clinical expectation of further LDL-C change over time.

RESULTS: At baseline, the median (interquartile range [IQR]) LDL-C level was 3.44 (2.73-4.15) mmol/L in the evolocumab cohort (n = 395) and 2.20 (1.72-2.92) mmol/L in the stable statin cohort (n = 4160). At follow-up, the mean (95% confidence interval [CI]) percentage reduction in LDL-C levels was 63.0% (60.5-65.5%) in the evolocumab cohort and 2.5% (0.3-4.7%) in the stable statin cohort.

CONCLUSIONS: LDL-C reductions in patients who added evolocumab to statin therapy in real-world clinical practice in China align with reductions observed in clinical trials.

PMID:40279014 | DOI:10.1007/s12325-025-03199-3

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Nevin Manimala Statistics

NeuroICU FastTrack: Rapid Disposition of Patients with Intracerebral Hemorrhage from the Emergency Department to Neuro-ICU

Neurocrit Care. 2025 Apr 25. doi: 10.1007/s12028-025-02247-8. Online ahead of print.

ABSTRACT

BACKGROUND: Emergency department length of stay (EDLOS) directly impacts outcomes of critically ill patients, with the risk of in-hospital mortality increasing by nearly 40% when an intensive care unit (ICU) bed is delayed beyond 4 h. Patients with intracerebral hemorrhage (ICH) suffer from worse functional outcomes and higher mortality when EDLOS exceeds 5 h, even for EDLOS exceeding just 1 h. Our goal was to implement an expedited triage pathway to reduce EDLOS of patients with ICH to less than 3 h and evaluate for downstream reduced morbidity and mortality.

METHODS: We conducted a retrospective analysis of patients with ICH evaluated in the emergency department (ED) at an academic comprehensive stroke center between January 1, 2022, and June 30, 2023. Univariate and multivariate logistic regression analyses were conducted to investigate the association between the NeuroICU FastTrack intervention with EDLOS less than 3 h and the rate of in-hospital mortality.

RESULTS: A total of 234 patients with ICH arrived to the ED and were admitted to the neuro-ICU. Post implementation, there was a statistically significant decrease in EDLOS from an average of 6.6 h to 4 h (p < 0.001) and a significant decrease in patient mortality (p = 0.006). There was also a reduction in mortality to 9.3% (p = 0.006) compared to a preintervention mortality rate of 22.9%. Additionally, the morbidity outcome (mRS of 0-2) remained relatively constant in both groups preintervention (23%) to post intervention (28%).

CONCLUSIONS: Consistent with prior published evidence and National Institute of Neurological Disorders and Stroke recommendations, a shorter EDLOS significantly decreased mortality, but there was no difference in morbidity in our population. The NeuroICU FastTrack process expedited critically ill ICH patient throughput from the ED to the ICU, enhanced bed availability through streamlined procedures, and improved patient outcomes.

PMID:40279011 | DOI:10.1007/s12028-025-02247-8

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Nevin Manimala Statistics

Early life adversity and white matter microstructural organization-a systematic review

Brain Imaging Behav. 2025 Apr 25. doi: 10.1007/s11682-025-01007-8. Online ahead of print.

ABSTRACT

Early life adversity, defined as exposure to stressful events during childhood, is a significant risk factor for the development of psychiatric disorders. Diffusion tensor imaging studies employing tract-based spatial statistics have shown microstructural abnormalities in white matter among individuals exposed to early life adversity; however, robust conclusions are yet to be drawn. This systematic review synthesizes findings of previous tract-based spatial statistics studies to identify the white matter alterations in adult brains exposed to early life adversity, in papers with methodological consistency. The literature search (April 2024) was conducted to identify tract-based spatial statistics studies that compared diffusion metrics between adults exposed to early life adversity and adults not. Embase, Pubmed, and PsycInfo were searched, retrieving 2458 articles. Following deduplication, 1739 titles and/or abstracts were screened. 1699 articles were excluded, and 40 full texts were reviewed. Seven articles, reporting on 764 subjects, met the inclusion criteria and were included in the narrative synthesis. Compared to controls, adults exposed to early life adversity showed lower fractional anisotropy values in white matter tracts of the limbic and visual processing systems, specifically the anterior thalamic radiation, inferior longitudinal fasciculus, corona radiata, uncinate fasciculus, inferior fronto-occipital fasciculus, and cingulum bundle. This systematic review highlights that early life adversity may underlie emotional dysregulation and contribute to an increased risk of psychopathology in later life and explores the potential neurobiological mechanisms that underpin these structural changes. Understanding these associations is crucial for developing targeted interventions aimed at mitigating the long-term impact of early life adversity.

PMID:40279009 | DOI:10.1007/s11682-025-01007-8

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Nevin Manimala Statistics

Artificial Intelligence to Determine Correct Midsagittal Plane in Dynamic Transperineal Ultrasound

J Clin Ultrasound. 2025 Apr 25. doi: 10.1002/jcu.24050. Online ahead of print.

ABSTRACT

PURPOSE: To create and validate a machine learning(ML) model that allows for identifying the correct capture of the midsagittal plane in a dynamic ultrasound study, as well as establishing its concordance with a senior explorer and a junior explorer.

METHODS: Observational and prospective study with 90 patients without pelvic floor pathology. Each patient was given an ultrasound video where the midsagittal plane of the pelvic floor was recorded at rest and during the Valsalva maneuver. A segmentation model was used that was trained on a previously published article, generating the segmentations of the 90 new videos to create the model. The algorithm selected to build the model in this project was XGBoost(Gradient Boosting). To obtain a tabular dataset on which to train the model, feature engineering was carried out on the raw segmentation data. The concordance of the model, of a junior examiner and a senior examiner, with the expert examiner was studied using the kappa index.

RESULTS: The first 60 videos were used to train the model and the last 30 videos were reserved for the test set. The model presented a kappa index 0.930(p < 0.001) with very good agreement for detection of the correct midsagittal plane. The junior explorer presented a very good agreement (kappa index = 0.930(p < 0.001)). The senior explorer presented a kappa index 0.789(p < 0.001) (good agreement) for detection of the correct midsagittal plane.

CONCLUSION: We have developed a model that allows determining the correct midsagittal plane captured through dynamic transperineal ultrasound with a level of agreement comparable to or greater than that of a junior or senior examiner, using expert examiner assessment as the gold standard.

PMID:40276937 | DOI:10.1002/jcu.24050

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Nevin Manimala Statistics

Nurses’ compliance to ventilator-associated pneumonia prevention bundle and its effect on patient outcomes in intensive care units

Nurs Crit Care. 2025 May;30(3):e70043. doi: 10.1111/nicc.70043.

ABSTRACT

BACKGROUND: Ventilator-associated pneumonia (VAP) is a significant healthcare-associated infection. Compliance with VAP guidelines reduces infection and leads to better patient outcomes.

AIM: The study investigated the VAP rate, nurses’ compliance with the VAP bundle and the correlation between nurses’ compliance with the VAP bundle and key patient-related outcomes.

STUDY DESIGN: This descriptive correlational prospective study was conducted at two tertiary hospitals. All intensive care unit patients on mechanical ventilators who met the inclusion criteria for 48 h or more were recruited. Data were analysed using descriptive statistics, Chi-square, independent t-test and Spearman’s rank correlation.

RESULTS: Out of the 103 patients recruited, 22.3% of patients developed VAP, with a VAP rate of 5.6 per thousand ventilator days. Nurses’ compliance with VAP guidelines in both hospitals was 69% and decreased over the admission period. Compliance with the VAP bundle was linked to less length of stay (rho = -0.260, p < .008), fewer mechanical ventilation days (rho = -0.300, p < .002) and less hospital cost (rho = -0.266, p < .007). The mean compliance with the VAP care bundle was higher in the non-VAP group (M = 72.9, SD = 23.79) than in patients who developed VAP (M = 56.6, SD = 18.96).

CONCLUSIONS: The findings underscore the critical need for healthcare organizations to prioritize strategies to enhance compliance with VAP guidelines for improved patient outcomes.

RELEVANCE TO CLINICAL PRACTICE: Ongoing quality improvement efforts through regular audits of the VAP bundle implementation are crucial for reducing infections and complications and improving patient outcomes. Future research is recommended to investigate factors that impact nurses’ adherence to VAP guidelines to develop interventions to enhance compliance.

PMID:40276934 | DOI:10.1111/nicc.70043

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Nevin Manimala Statistics

Real-World Evidence in New Drug and Biologics License Application Approvals During Fiscal Years 2020-2022

Clin Pharmacol Ther. 2025 Apr 25. doi: 10.1002/cpt.3688. Online ahead of print.

ABSTRACT

Improvements in the relevance and reliability of routinely collected clinical data and statistical methods to analyze the available data have enhanced the adoption of real-world data (RWD) to generate real-world evidence (RWE) for regulatory decision making of medical products. As part of the reauthorization of the Prescription Drug User Fee Act (PDUFA VII), the US Food and Drug Administration (FDA) committed to issuing annual reports describing such uses for drugs and biological products. The first report covered fiscal year (FY) 2023 and described two approvals based, at least in part, on RWE: tocilizumab (trade name Actemra) and lacosamide (trade name Vimpat). This article describes New Drug Applications and Biologics Licensing Applications approved by the Center for Drug Evaluation and Research (CDER) in FYs 2020-2022 with RWE that (1) contributed to substantial evidence of effectiveness or (2) provided safety data necessary for approval. RWE contributed to substantial evidence of effectiveness for the approval of applications for fosdenopterin (trade name Nulibry) and tacrolimus (trade name Prograf) in FY 2021 and abatacept (trade name Orencia), vosoritide (trade name Voxzogo), and alpelisib (trade name Vijoice) in FY 2022. No studies provided only safety data necessary for approval. The five approvals included six total studies that provided RWE pivotal for the applications approval. Four studies leveraged registry data, and two leveraged medical record data. In parallel with annual RWE public reporting under PDUFA VII, this report can inform interested parties regarding how RWD are used to generate RWE that can support regulatory decision making for medical products.

PMID:40276902 | DOI:10.1002/cpt.3688