Tag: statistics

Int J Gynaecol Obstet. 2026 Jan 23. doi: 10.1002/ijgo.70807. Online ahead of print.

ABSTRACT

OBJECTIVE: To investigate the diagnostic utility of three non-invasive hepatic fibrosis indices-aminotransferase-to-platelet ratio index (APRI), Fibrosis-4 (FIB-4), and FIB-5-in pregnancies complicated by intrahepatic cholestasis of pregnancy (ICP), and exploratory analysis of neonatal outcomes.

METHODS: This retrospective case-control study included 217 pregnant women who delivered at Göztepe Prof. Dr. Süleyman Yalçın City Hospital, a tertiary care center affiliated with Istanbul Medeniyet University, between September 2018 and February 2024. The study population was divided into two groups: 105 women diagnosed with ICP and 112 pregnant women without ICP who served as controls. The diagnosis of ICP was based on clinical pruritus, elevated serum bile acid levels (>10 μmol/L), and abnormal liver function tests. Women with pre-eclampsia, HELLP (hemolysis, elevated liver enzymes, and low platelets) syndrome, coagulopathy, hepatitis, multiple pregnancies, or other hepatic conditions were excluded. Laboratory parameters including aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), albumin, and platelet counts were used to calculate APRI, FIB-4, and FIB-5 scores. Statistical analyses included Mann-Whitney U-tests for group comparisons and receiver operating characteristics (ROC) curve analyses to determine the diagnostic performance of each score.

RESULTS: APRI and FIB-5 scores were significantly higher in the ICP group compared with controls, whereas FIB-4 showed a smaller between-group difference (P < 0.001 for APRI and FIB-5; P = 0.022 for FIB-4). ROC analysis demonstrated good diagnostic performance for APRI (area nder the curve [AUC] = 0.902; cut-off = 0.39; sensitivity = 82%; specificity = 89%) and moderate performance for FIB-5 (AUC = 0.718; cut-off = -1.84; sensitivity = 67%; specificity = 70%). FIB-4 showed lower diagnostic value (AUC = 0.590). Elevated scores were also associated with adverse neonatal outcomes, increased rates of preterm birth, and greater need for neonatal intensive care.

CONCLUSION: APRI, FIB-4, and FIB-5 are elevated in pregnancies affected by ICP and may serve as supportive, non-invasive markers reflecting hepatocellular stress and hepatic involvement. Among these indices, APRI showed the best diagnostic performance, FIB-5 demonstrated moderate discriminative ability, and FIB-4 had limited diagnostic utility. These indices may provide clinicians with additional information when evaluating hepatic dysfunction and may be associated with neonatal outcomes, although they are not validated prognostic tools. Prospective studies are warranted to further validate their clinical utility.

PMID:41574414 | DOI:10.1002/ijgo.70807

J Clin Pharmacol. 2026 Jan;66(1):e70139. doi: 10.1002/jcph.70139.

ABSTRACT

Valproic acid (VPA) is highly protein-bound, thereby impacting its free fraction and clearance in hypoalbuminemia. There is limited data on VPA use in such patients. Thus, this study evaluates the impact of adjusted VPA concentration (aVPAc) in predicting effectiveness and adverse effects compared to total VPA (tVPA) levels in hypoalbuminemic patients. A retrospective cohort study involved adult patients with seizures or epilepsy between January 1, 2016, and December 31, 2022. The levels of tVPA and aVPA (adjusted for albumin) were compared using receiver operating characteristic curves, and AUC differences were assessed using the DeLong method. Safety endpoints included hepatotoxicity, hyperammonemia, hyponatremia, and thrombocytopenia, while effectiveness endpoints were seizure occurrence, status epilepticus, and the use of additional antiepileptic medications during hospitalization. Of the 1621 screened patients, 71 with hypoalbuminemia received VPA. An aVPAc threshold of 154.19 mg/dL demonstrated higher sensitivity (86%) but lower specificity (47%) for predicting hepatotoxicity compared to a tVPA threshold of 67.53 mg/dL (sensitivity: 71%, specificity: 72%). Although aVPAc yielded a comparable negative predictive value (96% vs 95%), tVPA showed superior positive predictive value (25% vs 18%) and a higher Youden index (0.43 vs 0.33), indicating better overall discriminatory performance; however, these findings did not achieve statistical significance. In contrast, an aVPAc threshold of 188 mg/dL showed a sensitivity of 100% and a specificity of 82% for predicting hyperammonemia, which is superior to the tVPA threshold of 74.32 mg/dL that has a sensitivity of 40% and a specificity of 88%. The aVPAc also achieved a higher Youden index of 0.82 compared to 0.28 for tVPA. Adjusted VPA concentrations showed greater sensitivity than tVPA in predicting hepatotoxicity and hyperammonemia, suggesting potential utility for ruling out these adverse effects in hypoalbuminemic patients. Further research with a larger sample size is needed to validate these findings.

PMID:41574403 | DOI:10.1002/jcph.70139

Front Med (Lausanne). 2026 Jan 7;12:1715028. doi: 10.3389/fmed.2025.1715028. eCollection 2025.

ABSTRACT

BACKGROUND: Medical emergencies (MEs) in dental practice, though rare, can occur posing significant risks to patients. Dental professionals should be well-prepared to manage such situations. This study aimed to assess the knowledge, self-perceived confidence and preparedness of dental students and interns regarding the management of MEs in dental settings.

METHODS: A questionnaire-based cross-sectional study was conducted among clinical dental students and interns at a dental college in Saudi Arabia. Data were collected using an anonymous, self-administered online questionnaire consisting of 20 multiple-choice questions assessing knowledge, preparedness and confidence in handling MEs. Statistical analysis was performed using SPSS and employing Pearson’s Chi-squared test and logistic regression analysis.

RESULTS: The study analyzed data from 145 out of 200 participants invited (response rate = 72.5%). Most participants were female (51.0%) and aged ≥ 24 years (62.8%). A high knowledge level was identified in 58.6% of participating students and interns. While females exhibited a slightly higher knowledge than males, higher confidence and preparedness levels were identified among males, though the difference was not statistically significant (p = 0.05). Older and more advanced students demonstrated significantly higher knowledge and confidence (p < 0.05). The most encountered emergency by participants during dental treatment was syncope (65.5%), and seizures (29.6%). Adrenaline was the most commonly cited emergency drug in terms of availability in dental practices (38.6%), followed by anti-histamines (23.4%), while atropine was the least available (13.8%). Notably, 58.6% of participants reported lack of these emergency drugs in their practice settings.

CONCLUSION: The study highlighted a gap in the preparedness of dental students and interns to manage MEs effectively. The findings emphasize the need for enhanced training and education, particularly in managing more severe medical emergencies, to improve the overall emergency response in dental practices. Further, efforts should focus on increasing access to emergency drugs and equipment, along with regular BLS training, to ensure optimal patient safety.

PMID:41574378 | PMC:PMC12819686 | DOI:10.3389/fmed.2025.1715028

Front Med (Lausanne). 2026 Jan 7;12:1661619. doi: 10.3389/fmed.2025.1661619. eCollection 2025.

ABSTRACT

OBJECTIVES: We utilized high-frequency ultrasound to characterize vulvar skin alterations in lichenoid vulvar dermatoses (LVD) and to determine whether the sonographic vascular index (VI) correlates with histopathological microvessel density (MVD) and microvessel area (MVA).

METHODS: This study included thirty-seven patients with pathologically confirmed LVD who attended Henan Provincial People’s Hospital between December 2021 and May 2024. A control group of thirty-five healthy women, matched for age and BMI was selected during the same period. High-frequency ultrasound parameters of the vulvar skin between the two groups were analyzed using statistical tests. Vulvar skin specimens from LVD patients were stained with CD34 to determine MVD and MVA, and the correlation with the VI from ultrasound parameters was assessed.

RESULTS: (i) Analysis of variance showed that epidermal thickness, subepidermal low echogenic band (SLEB) thickness, dermal thickness, and VI were significantly increased in the LVD group compared to the control group (all P < 0.05). (ii) Correlation analysis revealed a positive correlation between the VI and MVD, MVA (r = 0.438, r = 0.630, both P < 0.05).

CONCLUSION: The vulvar skin thickness and VI in patients with LVD are increased compared to the control group. The VI reflects the microvascular status in LVD, highlighting the significant value of high-frequency ultrasound in assessing LVD.

PMID:41574372 | PMC:PMC12819178 | DOI:10.3389/fmed.2025.1661619

Front Med (Lausanne). 2026 Jan 7;12:1678666. doi: 10.3389/fmed.2025.1678666. eCollection 2025.

ABSTRACT

BACKGROUND: Pharmacy education is undergoing global transformation to better align with evolving healthcare demands. However, in Romania, pharmacy curricula remain centrally regulated and standardized, with limited input from graduates or employers.

OBJECTIVE: This study investigates the perceptions of Romanian pharmacy graduates (2009-2023) regarding the relevance of their curriculum, competency development, and professional preparedness across various employment sectors.

METHODS: A mixed-methods, cross-sectional survey was conducted with 473 alumni from all accredited pharmacy faculties in Romania. Quantitative data were analyzed using descriptive statistics, ANOVA, and logistic regression, while qualitative responses underwent thematic content analysis.

RESULTS: Graduates reported moderate overall preparedness (Mean = 3.08/5), with significant variation by institution, age, and job sector. High self-assessed competencies were noted in Pharmacology and Communication, while Management, Regulatory Affairs, and Therapy management were identified as key gaps. Disciplines such as Pharmacology and Clinical Pharmacy were rated highly useful, whereas Physics and Inorganic Chemistry were frequently cited as disproportionately difficult and less applicable. Open-ended responses emphasized the need for greater curricular flexibility, experiential learning, and integration of soft skills and entrepreneurship.

CONCLUSION: The results highlight a misalignment between standardized pharmacy education and the diverse realities of professional practice. The study advocates for alumni-informed reforms, modular curricula, and the integration of transversal competencies to enhance workforce readiness and sector-specific applicability.

PMID:41574364 | PMC:PMC12819258 | DOI:10.3389/fmed.2025.1678666

Front Med (Lausanne). 2026 Jan 7;12:1699607. doi: 10.3389/fmed.2025.1699607. eCollection 2025.

ABSTRACT

OBJECTIVE: Metagenomic Next Generation Sequencing (mNGS) offers a rapid, unbiased, and culture-independent approach to pathogen identification by analyzing all nucleic acids present in clinical samples. Despite its growing use, the diagnostic utility of mNGS in bone infections remains inadequately characterized. This study aimed to assess the diagnostic accuracy of mNGS compared to conventional microbial cultures and to explore its associations with clinical severity and patient outcomes.

METHODS: We retrospectively enrolled 135 adult patients treated for suspected bone infections between October 2023 to January 2025 at Union Hospital, Tongji Medical College. Among these, 101 patients were classified as the infection group (IG) based on clinical and laboratory criteria, encompassing osteomyelitis, post-traumatic limb infections, and diabetic foot infections. mNGS results were compared to traditional cultures in terms of sensitivity, specificity, predictive values, and discordant cases. The IG was further stratified into mNGS-positive (n = 95) and mNGS-negative (n = 6) subgroups. Clinical parameters-including leukocyte differentials, C-reactive protein (CRP), procalcitonin (PCT), albumin, length of hospital stay, and mortality-were analyzed in relation to mNGS findings.

RESULTS: Among all patients, 74.81% were confirmed to have infections. mNGS demonstrated a markedly higher sensitivity than culture (94.06% vs. 47.52%, p = 0.000) while maintaining comparable specificity (85.29% vs. 76.47%, p = 0.549). Age showed a potential trend in influencing mNGS positivity (p = 0.092). Although not statistically significant, mNGS-positive patients tended to have longer hospitalizations (p = 0.098), suggesting possible associations with infection complexity or pathogen load.

CONCLUSION: mNGS substantially enhances the diagnostic yield for bone infections, particularly in polymicrobial, low-abundance, or culture-negative scenarios. mNGS-negative patients had significantly shorter hospital stays and a lower rehospitalization rate. Its rapid and comprehensive pathogen detection may enable more timely and targeted antimicrobial therapy, potentially improving patient outcomes and reducing healthcare burden. These findings support the integration of mNGS as a valuable adjunct to conventional diagnostic workflows in orthopedic infectious diseases.

PMID:41574363 | PMC:PMC12819182 | DOI:10.3389/fmed.2025.1699607

Front Microbiol. 2026 Jan 7;16:1704508. doi: 10.3389/fmicb.2025.1704508. eCollection 2025.

ABSTRACT

OBJECTIVE: Helicobacter pylori (H. pylori) infection represents a global health challenge. This study aimed to evaluate the effect of probiotic supplementation on the efficacy and safety of bismuth-containing quadruple therapy (BQT) for H. pylori eradication.

METHODS: Randomized controlled trials (RCTs) meeting the eligibility criteria were identified through systematic searches of five databases, including PubMed, Embase, Cochrane Library, Web of Science, and ClinicalTrials.gov. Meta-analyses were conducted using Review Manager software with a random-effects model to calculate pooled relative risks (RR) and 95% confidence intervals (CI). The potential publication bias was evaluated qualitatively, and the certainty of the evidence was subsequently assessed.

RESULTS: In total, 10 RCTs involving 1,630 patients were included in the analysis. The results demonstrated that, compared with the BQT group, the H. pylori eradication rate was significantly higher in the probiotics combined with the BQT group (RR 1.06, 95% CI 1.01-1.11, p = 0.009, ARR = 7.5%, NNT ≈ 13). Additionally, the combined therapy significantly reduced the adverse event rate (RR 0.58, 95% CI 0.42-0.80, p = 0.001, ARR = 11.1%, NNT ≈ 9), diarrhea (RR 0.48, 95% CI 0.32-0.73, p = 0.0007, ARR = 0.7%, NNT ≈ 142), and constipation (RR 0.53, 95% CI 0.29-0.94, p = 0.04, ARR = 2.5%, NNT ≈ 40). However, no statistically significant differences were observed for other specific adverse events, including nausea, vomiting, anorexia, heartburn, belching, taste disturbance, abdominal pain, and abdominal bloating. Sensitivity analyses confirmed the robustness of the results for the H. pylori eradication rate and adverse event rate.

CONCLUSION: Combining probiotics with BQT significantly increases the H. pylori eradication rate and reduces adverse events, particularly diarrhea and constipation. These findings support the role of probiotics as a supplementary strategy to enhance both the efficacy and safety of H. pylori eradication therapy. However, the overall certainty of the evidence is low to very low, and the optimal probiotic protocol has yet to be determined, highlighting the need for further high-quality research.

SYSTEMATIC REVIEW REGISTRATION: https://www.crd.york.ac.uk/PROSPERO/view/CRD420251060806, Identifier CRD420251060806.

PMID:41574348 | PMC:PMC12819727 | DOI:10.3389/fmicb.2025.1704508

Med Cannabis Cannabinoids. 2025 Dec 9;9(1):1-14. doi: 10.1159/000549902. eCollection 2026 Jan-Dec.

ABSTRACT

INTRODUCTION: This decentralized, randomized, triple-blind, placebo-controlled study evaluated efficacy and safety of oral cannabigerol (CBG) in Veterans with sleep issues.

METHODS: After a 2-week run-in phase, participants received CBG (25 mg daily for 2 weeks, then 50 mg daily for a further 2 weeks) or placebo. The primary endpoint was change in sleep quality via the Medical Outcomes Study Sleep Problems Index II questionnaire (MOS-SS SPI-II). Additional endpoints included change in quality of life measured via the World Health Organization Disability Assessment Schedule, version 2.0 instrument (WHODAS-2.0-12), post-traumatic stress disorder (PTSD) symptoms evaluated via the PTSD Checklist for the Diagnostic and Statistical Manual of Mental Disorders-Fifth Edition (PCL-5 (PCL-5), and sleep actigraphy data via Fitbit.

RESULTS: A total of 63 participants were randomized to receive CBG (n = 33) or placebo (n = 30). A total of 35 participants completed the study without major protocol deviations (CBG [n = 18]; placebo [n = 17]). MOS-SS SPI-II scores indicated improved sleep with no statistically significant difference between the CBG and placebo groups. Similar patterns were observed for WHODAS-2.0-12 and PCL-5 scores. CBG was well tolerated.

CONCLUSION: While no firm conclusion on the efficacy of CBG in improving sleep can be made, the favorable safety profile supports future studies with CBG. ClinicalTrials.gov ID: NCT05088018.

PMID:41574318 | PMC:PMC12823110 | DOI:10.1159/000549902

Front Cell Infect Microbiol. 2026 Jan 7;15:1711410. doi: 10.3389/fcimb.2025.1711410. eCollection 2025.

ABSTRACT

INTRODUCTION: The aim of this study was to describe the epidemiology and clinical outcomes of respiratory syncytial virus (RSV) infection in hospitalized children and adults from a sentinel surveillance network in Lebanon, and to compare the RSV rates and seasonality before and during COVID-19 pandemic.

METHODS: This study was based on the data from the Lebanese component of the Global Influenza Hospital Surveillance Network (GIHSN) during three consecutive seasons between 2019-2021 at six hospitals, following a standardized protocol based on age-specific criteria. Specimens were tested for RSV. The epidemiologic, clinical, and severity characteristics were analyzed. Descriptive statistics were used to summarize demographics, RSV rate, and outcomes. Univariate analyses were performed using Pearson’s Chi-square or Fisher’s exact test, and associations were expressed as unadjusted odds ratios (95% CI). A p-value ≤0.05 was considered significant.

RESULTS: From January 2019 to September 2021, 2,626 of 7,081 eligible inpatients were enrolled in the study, with 188 tested positives for RSV (7.3%). The majority (74.5%) of RSV-positive subjects were children under 5 years of age, and 9.6% of patients were ≥ 65 years of age. The positivity rate varied across seasons (2.1%-11.1%) (p-value <0.001); the 2020-2021 season -was disrupted by COVID-19 pandemic – recording the lowest rate of 1.1% (p-value <0.001) during the typical winter months followed by an off-season RSV resurgence. Fever, cough, nasal congestion, wheezing, neurological symptoms, diarrhea and decreased oral intake were significantly associated with RSV infection (p < 0.05). Cough and wheezing were predominant in RSV-positive children <5 and adults aged ≥ 65 years. Among RSV-positive subjects, 8% required ICU admission, 5.3% received mechanical ventilation, and 2.7% died. Severe outcomes were more common in those ≥65 years, and the presence of ≥2 comorbidities and underlying cardiovascular disease significantly increased the risks of mechanical ventilation (OR = 7.44 [1.13-48.99], p-value 0.037 and OR = 8.32 [2.20-31.37], p-value 0.004, respectively) and in-hospital death (OR = 22.67 [1.91-268.50], p-value 0.013 and OR = 11.50 [1.82-72.85], p-value 0.016, respectively).

CONCLUSIONS: This study demonstrates the significant burden of RSV, especially in young infants with or without co-morbidities and in older adults with co-morbidities. Given the recent rollout of RSV vaccines and monoclonal antibodies, continued surveillance is needed to monitor changes in epidemiology, seasonality, and disease burden, especially in low- and middle-income countries.

PMID:41574300 | PMC:PMC12819600 | DOI:10.3389/fcimb.2025.1711410

Front Vet Sci. 2026 Jan 7;12:1737842. doi: 10.3389/fvets.2025.1737842. eCollection 2025.

ABSTRACT

INTRODUCTION: Hemostatic dysfunctions are frequent in critically ill dogs and can markedly affect clinical outcomes. Conventional plasma-based coagulation testing provides limited insight into the complex in vivo interactions among platelets, red blood cells, and coagulation factors. Viscoelastic testing has emerged to overcome these limitations by assessing the dynamics of clot formation and breakdown in whole blood. Among these, ROtational ThromboElastoMetry (ROTEM) provides a real-time evaluation of the coagulation process, reflecting clot initiation, propagation, and lysis. The recently developed ROTEM Sigma analyzer automates reagent handling and measurement minimizing operator variability and pre-analytical errors. Despite its growing use in human medicine, canine reference intervals for the ROTEM Sigma platform have not yet been established.

OBJECTIVE: To determine the reference intervals for ROTEM Sigma parameters in healthy dogs, to compare these values with published ROTEM Delta data, and to assess the influence of physiological variables such as age, sex, body weight, and neuter status.

METHODS: A prospective observational study was conducted in 42 clinically healthy dogs. Whole blood samples were analyzed using ROTEM Sigma EXTEM, INTEM, FIBTEM, and HEPTEM assays. Reference intervals were generated using both conventional parametric and robust median-MAD statistical methods. Comparisons were made with previously reported canine ROTEM Delta data. Multivariate regression explored associations between ROTEM parameters and demographic or hematologic variables.

RESULTS: Reference intervals were successfully defined for all ROTEM Sigma parameters (CT, CFT, A10, MCF, LI60, and G). EXTEM values agreed most closely with previously published ROTEM Delta data, whereas INTEM and FIBTEM exhibited greater variability. Regression analysis identified maximum clot firmness (MCF) as the only parameter significantly affected by biological variables. MCF decreased with higher body weight, increased with platelet count and showed minor sex-related differences.

CONCLUSION: This study establishes canine-specific ROTEM Sigma reference intervals. The close concordance with Delta data more (particularly EXTEM) suggests cross platform consistency while highlighting the necessity of dedicated Sigma-specific reference ranges. Body weight, sex, and platelet count were the primary determinants of MCF. These validated reference intervals enhance the clinical applicability of ROTEM Sigma for assessing hemostatic function in dogs.

PMID:41574258 | PMC:PMC12819721 | DOI:10.3389/fvets.2025.1737842