Category: Statistics

Ann Surg. 2025 May 21. doi: 10.1097/SLA.0000000000006760. Online ahead of print.

ABSTRACT

OBJECTIVE: To assess the efficacy and safety of hypovolemic phlebotomy (HP) versus conventional management (control group) in achieving low central venous pressure (CVP) to reduce blood loss during open liver resections.

BACKGROUND: Excessive blood loss increases perioperative complications and worsen patient outcomes. HP is used to reduce blood loss and the need for allogenic transfusions. This study compares intraoperative blood loss between HP and conventional techniques in liver resection.

METHODS: This prospective, randomized controlled trial, conducted between 2020 and 2024, evaluated intraoperative blood loss as the primary endpoint, with secondary endpoints of allogenic transfusion and postoperative outcomes.

RESULTS: One hundred participants were randomized to either HP or control groups, with similar baseline characteristics. The HP group had significantly lower blood loss during parenchymal transection (300 (250-500) vs. 500 (300-750) mL, difference = 150, 95% CI [50, 275]; P = 0.02), shorter time to achieve low CVP (50 (30-100) vs. 107.5 (45-150) minutes, difference = -75.0, 95% CI [-95.0, -56.0]; P = 0.01), and a lower surgical bleeding score (2 (1-3) vs. 2 (2-4), difference = -1.0, 95% CI [-1.0, -0.5]; P = 0.01). Transfusion rates and postoperative complications were similar. HP was an independent protective against blood loss > 500 mL (AOR = 0.19, 95% CI [0.04-0.80]; P = 0.02).

CONCLUSIONS: HP significantly reduces intraoperative blood loss and enhances bleeding control by achieving low CVP more quickly. It is an effective technique for minimizing blood loss and improving outcomes in open liver resections.

PMID:40396243 | DOI:10.1097/SLA.0000000000006760

Front Immunol. 2025 May 6;16:1490637. doi: 10.3389/fimmu.2025.1490637. eCollection 2025.

ABSTRACT

INTRODUCTION: Changes in oral neutrophil number and function may occur in patients after orthodontic treatment, affecting the oral immune microenvironment. However, the specific mechanisms are unclear. In this study, we describe the changes in the levels of neutrophil extracellular traps (NET) markers and inflammatory factors in the gingival crevicular fluid (GCF) and saliva of patients after orthodontic treatment and further explore the correlation between them.

METHODS: 68 patients underwent fixed orthodontic treatment in the Department of Orthodontics from January 2021 to June 2023 were selected. GCF and saliva samples were collected from the patients 1 day before orthodontic treatment and 2 h, 24 h, and 1 week after orthodontic treatment to evaluate changes in NET marker and inflammatory factors. The differences in and associations between NET markers and inflammatory cytokine levels in the GCF and saliva of patients were evaluated.

RESULTS: After fixed orthodontic treatment, the neutrophil elastase (NE), myeloperoxidase (MPO), citrullinated histone 3 (CitH3), and MPO-DNA in the GCF and saliva of the patients increased gradually, the interleukin (IL)-1β and IL-8 in the GCF increased gradually, and there were significant differences among the different time points (P<0.05). There was a positive correlation between the NE, MPO, CitH3, MPO-DNA, IL-1β and IL-8 in the GCF of patients at 2 hours and 24 hours after orthodontic treatment (P<0.05). There was a significant positive correlation between the GCF and saliva levels of NE, MPO, CitH3, MPO-DNA, IL-1β and IL-8 (P<0.05); however, there was no statistically sex- or age-dependent differences in the NE, MPO, CitH3, MPO-DNA, IL-1β and IL-8 levels in the GCF of orthodontic patients (P>0.05).

CONCLUSION: This study significantly reveals that NET marker levels in the GCF and saliva rapidly change following the initial orthodontic arch wire stress. The inflammation in periodontal tissues induced by orthodontic stress has the potential to trigger oral inflammation via the GCF. These findings are crucial for understanding the oral immune microenvironment changes during orthodontic treatment, providing a theoretical basis for preventing and treating orthodontic – related periodontal complications, thus having important implications for improving orthodontic treatment outcomes.

PMID:40396177 | PMC:PMC12089083 | DOI:10.3389/fimmu.2025.1490637

Front Public Health. 2025 May 6;13:1557538. doi: 10.3389/fpubh.2025.1557538. eCollection 2025.

ABSTRACT

OBJECTIVE: To compare the impact of a package of interventions on surface cleaning and disinfection in two public and private neonatal intensive care units (NICUs).

METHOD: This is a quasi-experimental, quantitative study. The study consisted of three phases: baseline (phase I), implementation of the intervention package without feedback to the team (phase II), and, finally, short-term monitoring with feedback to the team (phase III). A total of 864 evaluations were carried out according to the monitoring methods: adenosine triphosphate, visual inspection, microbial load counting, and detection of Staphylococcus aureus and testing for its methicillin resistance (MRSA) in each unit over 4 months, evaluating six high-frequency touch surfaces, before and after cleaning and disinfection carried out by nursing and sanitizing professionals.

RESULTS: When comparing the effect of the package in the two units (public and private), no significant differences were found in the proportions of MRSA-positive surfaces in all the phases evaluated. The same occurred concerning the ATP method, which showed no significant differences between the hospitals in all study phases. Concerning the microbial count, in phase II of the study, only on one surface (scales) was a significantly lower difference found in the private hospital compared to the public one. Visual inspection indicated that the private NICU had a substantially higher proportion of surfaces with adequate hygiene in phase I: the infusion pump and the armchair; in phase II, the counter and in phase III again the counter surface. Concerning human factors, when comparing the two institutions, there were no statistically significant associations or correlations with job satisfaction. However, the public institution had higher work performance scores than the private one.

CONCLUSION: The study highlights that the rigorous implementation of intervention packages for cleaning in NICUs, even though they are different, still showed similar results in terms of effectiveness for all the methods used, except visual inspection. This study showed that even though the employees had various levels of work performance, there was still a similar effect on the outcome of the intervention package.

PMID:40396167 | PMC:PMC12088969 | DOI:10.3389/fpubh.2025.1557538

Clin Ophthalmol. 2025 May 16;19:1583-1591. doi: 10.2147/OPTH.S513009. eCollection 2025.

ABSTRACT

PURPOSE: To evaluate the visual and anatomical outcomes of switching diabetic macular oedema (DMO) patients with suboptimal response to aflibercept 2mg to faricimab over a 12-month period.

PATIENTS AND METHODS: This retrospective single centre study enrolled 62 eyes from 50 patients with diabetic macular oedema (DMO) who demonstrated a sub-optimal response to aflibercept 2mg. Sub-optimal response was defined by a central subfield thickness (CST) exceeding 325µm or greater than 20% increase from the best CST despite receiving aflibercept 2mg at intervals of 8 weeks or less. Patients had received at least six 4-weekly doses of aflibercept 2mg. Faricimab was administered as four intravitreal loading injections at 4-weekly intervals, followed by a treat-and-extend approach. Outcome measures, including best-recorded visual acuity (BRVA), CST, and treatment intervals, were assessed at baseline, post-loading (6.5 ± 1.9 weeks) and at the latest clinic review (57.1 ± 19.7 weeks). Statistical analysis included paired t-tests (normal distribution) and Wilcoxon signed-rank tests (non-normal distribution), with p < 0.05 considered statistically significant.

RESULTS: Mean age was 63.9 (±11.4) years, 56% participants were male. At baseline, the mean BRVA was 67.6 (±11.8) letters, and CST measured 406.4 (±105.9) µm. The initial mean treatment interval was 6.5 (±1.8) weeks. BRVA increased to 70.4 (±12.7) letters (p=0.008), while CST reduced to 372.8 (±132.0) µm (p=0.002). The mean injection interval extended to 7.4 (±2.6) weeks (p=0.03). At the latest follow-up BRVA was maintained at 68.7 (±14.6) letters (p=0.572), and CST reduced further to 343.1 (±117.5) µm (p=0.020). At the final follow-up 53.2% were on ≥8-weekly intervals. The mean injection interval increased to 9.2 (±3.2) weeks (p < 0.001), and a mean of 7.92 (±2.53) faricimab injections was administered.

CONCLUSION: DMO patients with sub-optimal response to aflibercept 2mg experienced improved anatomical outcomes and extended treatment intervals while maintaining vision on faricimab, with no new safety concerns.

PMID:40396158 | PMC:PMC12091065 | DOI:10.2147/OPTH.S513009

Clin Ophthalmol. 2025 May 16;19:1593-1607. doi: 10.2147/OPTH.S521558. eCollection 2025.

ABSTRACT

BACKGROUND: Idiopathic macular hole is an ophthalmic disease that seriously affects vision, and its early diagnosis and treatment have important clinical significance to reduce the occurrence of blindness. At present, OCT is the gold standard for diagnosing this disease, but its application is limited due to the need for professional ophthalmologist to diagnose it. The introduction of artificial intelligence will break this situation and make its diagnosis efficient, and how to build an effective predictive model is the key to the problem, and more clinical trials are still needed to verify it.

OBJECTIVE: This study aims to evaluate the role of deep learning systems in Idiopathic Macular Hole diagnosis, grading, and prediction.

METHODS: A single-center, retrospective study used binocular OCT images from IMH patients at the First Affiliated Hospital of Nanchang University (November 2019 – January 2023). A deep learning algorithm, including traditional omics, Resnet101, and fusion models incorporating multi-feature fusion and transfer learning, was developed. Model performance was evaluated using accuracy and AUC. Logistic regression analyzed clinical factors, and a nomogram predicted surgical risk. Analysis was conducted with SPSS 22.0 and R 3.6.3. P < 0.05 was statistically significant.

RESULTS: Among 229 OCT images, the traditional omics, Resnet101, and fusion models achieved accuracies of 93%, 94%, and 95%, respectively, in the training set. In the test set, the fusion model and Resnet101 correctly identified 39 images, while the traditional omics model identified 35. The nomogram had a C-index of 0.996, with macular hole diameter most strongly associated with surgical risk.

CONCLUSION: The deep learning system with transfer learning and multi-feature fusion effectively diagnoses and grades IMH from OCT images.

PMID:40396157 | PMC:PMC12091069 | DOI:10.2147/OPTH.S521558

Pediatr Gastroenterol Hepatol Nutr. 2025 May;28(3):176-184. doi: 10.5223/pghn.2025.28.3.176. Epub 2025 May 8.

ABSTRACT

PURPOSE: Functional dyspepsia (FD) is a chronic disorder characterized by upper abdominal symptoms in the absence of an identifiable organic cause. Although the efficacy of acotiamide has been demonstrated in adults with FD, its effectiveness in pediatric patients remains unclear. This study aimed to evaluate the efficacy of acotiamide in pediatric patients with FD.

METHODS: We conducted a retrospective analysis of 33 patients with FD, aged <16 years, who received acotiamide at a single children’s hospital between August 2013 and March 2022.

RESULTS: Symptomatic improvement was observed in 57.6% (19/33) of patients one month after acotiamide administration. The improvement rates were 63.6%, 20.0%, and 66.7% among patients with epigastric pain syndrome (EPS), postprandial distress syndrome (PDS), and overlap PDS-EPS, respectively. No statistically significant differences in symptomatic improvement rates were noted among the subtypes (p=0.213). Two patients discontinued acotiamide because of abdominal pain, but no serious adverse events were reported.

CONCLUSION: Acotiamide demonstrated efficacy in pediatric FD, which is consistent with previously reported outcomes in adults. Acotiamide may be a beneficial treatment option for pediatric FD across all subtypes.

PMID:40396150 | PMC:PMC12088856 | DOI:10.5223/pghn.2025.28.3.176

Mechanobiol Med. 2024 Oct 1;3(1):100098. doi: 10.1016/j.mbm.2024.100098. eCollection 2025 Mar.

ABSTRACT

Even though the link between foot posture and lower-extremity injuries remains controversial, there has been little research focus on bilateral foot symmetry. This study evaluated the correlation between bilateral symmetry in foot posture and lower extremity musculoskeletal injuries among workers in physically intensive occupations. A total of 248 participants with physically demanding roles were enrolled. Historical data on lower-limb musculoskeletal injuries were obtained through a review of medical records, supplemented by results from on-site consultations. The foot arch index (AI) was quantitatively measured using a 3D laser foot scanner, and foot posture was evaluated using the foot posture index-6 (FPI-6). The participants were categorized into subgroups based on bilateral symmetry assessments of their feet. Logistic regression analyses were performed for statistical comparisons after adjusting for potential confounding factors. The results indicate that abnormalities in foot posture and arch, assessed using the FPI-6 and AI, were identified in 42.3 ​% and 47.2 ​% of participants, respectively, with 20.9 ​% and 16.5 ​% demonstrating bilateral asymmetry in these parameters. When comparing bilateral and unilateral foot protonation with bilaterally normal feet, the risk adjustments revealed differences of 2.274 (95 ​% CI: 1.094-4.729, P ​= ​0.028) and 2.751 (95 ​% CI: 1.222-6.191, P ​= ​0.015), respectively. Furthermore, the risk adjustment for age, BMI, smoking status, physical training years, training time, training frequency, warm-up before training, relaxation after training, MIS prevention, and treatment learning for unilateral flatfoot relative to bilateral normal feet was 3.197 (95 ​% CI:1.235-8.279, P ​= ​0.017). This study demonstrates that workers in physically demanding occupations who exhibit unilateral foot protonation or unilateral flatfoot are at an increased risk of lower-extremity musculoskeletal injuries.

PMID:40396133 | PMC:PMC12082154 | DOI:10.1016/j.mbm.2024.100098

Ther Adv Med Oncol. 2025 May 19;17:17588359251338046. doi: 10.1177/17588359251338046. eCollection 2025.

ABSTRACT

BACKGROUND: Targeted therapy with EGFR tyrosine-kinase inhibitors (TKIs) is the preferred first-line treatment for EGFR-mutated advanced non-small-cell lung cancer (NSCLC), but acquired resistance inevitably occurs in almost all responding individuals.

OBJECTIVES: We aimed to comprehensively review the literature to investigate the efficacy and safety of distinct regimens in the subsequent-line setting, thereby identifying the optimal regimen for these TKI-resistant NSCLC patients.

DESIGN: A systematic review and network meta-analysis (NMA) using a Bayesian framework.

DATA SOURCES AND METHODS: The PubMed, Embase, Cochrane Library databases, and abstracts of ASCO, ESMO, and WCLC were searched from database inception to November 3, 2024, to identify eligible randomized controlled trials (RCTs) that assessed distinct regimens for individuals with advanced EGFR-mutated NSCLC who progressed on TKIs. The outcomes of progression-free survival (PFS), overall survival (OS), objective response rate (ORR), disease control rate (DCR), and grade 3 or higher adverse events (⩾3AEs) were compared and ranked in overall patients and various subgroups among eight regimens by NMA and the surface under the cumulative ranking curve, respectively. The protocol is registered with PROSPERO, CRD42024601619.

RESULTS: In total, 14 RCTs, involving 3177 participants and 8 treatment regimens (chemotherapy plus ivonescimab (programmed cell death protein 1/vascular endothelial growth factor inhibitor; chemotherapy + ivonescimab (CT + IVO)); CT + amivantamab + lazertinib (CT + AMI + LAZ), CT + immunotherapy + bevacizumab (CT + IO + BEV), CT + AMI, CT + BEV, CT + IO, CT, and IO), were included. Overall, in patients, the most pronounced PFS benefit was observed with the “CT + IVO,” followed by “CT + AMI + LAZ,” “CT + IO + BEV,” and “CT + AMI,” ranked second, third, and fourth, respectively. In terms of OS, the regimen of “CT + AMI” ranked the best, followed by “CT + IVO.” However, the comparisons of OS among different regimens did not reach statistical significance, possibly due to immature data. The results for ORR and DCR were similar to those for OS, with “CT + AMI” topping the rankings, followed by “CT + AMI + LAZ.” In terms of safety, the incidence of ⩾3AEs was highest in “CT + AMI + LAZ,” followed by “CT + AMI.” In subgroup analysis, “CT + IVO” demonstrates stable PFS benefits across clinicopathological characteristics, ranking first in most subgroups. Due to the unavailability of OS subgroup data in most RCTs, many regimens were missing in the OS subgroup analysis.

CONCLUSION: Integrating the results of different clinical outcomes and subgroup analyses, we conclude that “CT + IVO” is the optimal treatment option with an acceptable safety profile for patients with advanced EGFR-mutated NSCLC who have progressed on TKIs. “CT + AMI + LAZ” and “CT + AMI” are alternative subsequent line options as well, with superior efficacy compared to immunotherapy-based or chemotherapy regimens, yet elevated toxicity profiles requiring vigilant management.

PMID:40396122 | PMC:PMC12089717 | DOI:10.1177/17588359251338046

J Family Med Prim Care. 2025 Apr;14(4):1252-1258. doi: 10.4103/jfmpc.jfmpc_1148_24. Epub 2025 Apr 25.

ABSTRACT

BACKGROUND: To develop a structured and harmonized causality assessment method has been a holy grail in pharmacovigilance. The Pharmacovigilance Programme of India (PvPI) recommends the use of the World Health Organization-Uppsala Monitoring Centre (WHO-UMC) scale, whereas many clinicians prefer the Naranjo algorithm for its simplicity. There is no universally accepted method for the causality grading of ADRs. In the present study, we assessed agreement and correlation between the two widely used causality assessment scales, that is, the WHO-UMC criteria and the Naranjo algorithm.

MATERIALS AND METHODS: In this study, 313 individual case safety reports were analyzed from April 1, 2020, to March 31, 2023, reported at the Adverse Drug Reaction Monitoring Center (AMC) at Kalpana Chawla Government Medical College, Karnal. Two well-trained independent groups performed a causality assessment. One group performed a causality assessment of 313 ADRs using the WHO-UMC criteria and the other group performed the same using the Naranjo algorithm. The agreement between two ADR causality scales was assessed using the weighted kappa (κ) test. Spearman’s correlation was also used to find the correlation between the two scales.

RESULTS: Cohen’s kappa coefficient (κ) statistical test was applied between the two scales (WHO-UMC scale and Naranjo algorithm) to find out the agreement between these two scales. A weak agreement was found between the two scales (Kappa statistics with 95% confidence interval = 0.463, [P < 0.001]). Spearman’s correlation coefficient was found to be 0.506.

CONCLUSION: The assessment of causality for adverse drug reactions (ADRs) is challenging, and none of the different methods available for assessing ADR causality is accepted as the gold standard. In our study, we found weak agreement between the WHO-UMC criteria and the Naranjo algorithm. It is essential to standardize the causality assessment tool to create a universally acceptable method for assessing causality. Further research is needed to establish a gold standard method for assessing the causality of adverse drug reactions.

PMID:40396111 | PMC:PMC12088569 | DOI:10.4103/jfmpc.jfmpc_1148_24

J Family Med Prim Care. 2025 Apr;14(4):1486-1493. doi: 10.4103/jfmpc.jfmpc_1833_24. Epub 2025 Apr 25.

ABSTRACT

INTRODUCTION: Oral cancer, particularly oral squamous cell carcinoma (OSCC), is a significant global health issue, with India facing one of the highest incidence rates due to widespread tobacco and alcohol use. This study examines the impact of demographic factors, adverse habits, and socioeconomic status on the development and progression of OSCC among patients in Kolkata, India.

MATERIALS AND METHODS: A cross-sectional, observational study was conducted on 100 OSCC patients and 100 control subjects at a tertiary care centre in Kolkata over a year. Data were collected through structured questionnaires detailing demographic characteristics, adverse habits, socioeconomic status, and clinical presentations. Statistical analysis was performed using SYSTAT, with Student’s t-test, Chi-square tests, and one-way ANOVA used to assess associations between variables.

RESULTS: The mean age of OSCC patients was 53.5 years, and 65% were male. Tobacco and alcohol use were prevalent, with OSCC patients showing higher frequencies and longer durations of use compared to controls. Statistically significant associations were observed between OSCC diagnosis and both tobacco smoking and chewing habits (P < 0.05), as well as lower socioeconomic status. The mean presentation delay was 4.4 months, commonly due to initial consultations at non-specialized facilities and lack of awareness, with tongue lesions as the most frequent complaint site. Histopathologically, 57% of cases were poorly differentiated squamous cell carcinoma, often diagnosed at TNM Stage II.

CONCLUSION: This study highlights that demographic factors, adverse habits, and socioeconomic status significantly influence OSCC risk and severity in Indian patients. The findings underscore the critical need for early detection initiatives, particularly in lower socioeconomic groups, and suggest that reducing tobacco and alcohol use can mitigate OSCC risk. Equipping the primary care physicians with the knowledge of primary prevention and enhanced public awareness are recommended to reduce presentation delays and improve patient outcomes.

PMID:40396110 | PMC:PMC12088539 | DOI:10.4103/jfmpc.jfmpc_1833_24