Category: Statistics

Radiol Med. 2024 Oct 22. doi: 10.1007/s11547-024-01897-6. Online ahead of print.

ABSTRACT

OBJECTIVE: This study, derived from the phase 3 SAFE trial (ClinicalTrials.gov identifier: NCT2236806), explores subclinical cardiac damage in breast cancer patients receiving anthracycline-based chemotherapy and left-sided breast radiation therapy (RT).

MATERIALS AND METHODS: Eligible patients were randomized to a cardioprotective pharmacological therapy (bisoprolol, ramipril, or both) or placebo, with cardiac surveillance at multiple time-point using standard and 3-dimensional echocardiography. Dosimetric parameters were analysed, including mean heart dose (MHD) and various metrics for heart substructures, employing advanced contouring techniques and auto-contouring software.

RESULTS: In the analysis of left-sided breast RT patients, the study encompassed 39 out of 46 irradiated individuals, focusing on GLS and 3D-LVEF outcomes with ≥ 10% worsening, defined as subclinical heart damage. Distinct RT schedules were used, with placebo exhibiting the highest ≥ 10% worsening (36.4%). In terms of treatment arms, bisoprolol exhibited 11.1% worsening, while ramipril 16.7% and bisoprolol + ramipril 25%. For patients with no subclinical damage, the mean MHD was 1.5 Gy; for patients with subclinical heart damage, the mean MHD was 1.6 Gy (p = 0.94). Dosimetric parameters related to heart and heart substructures (left anterior descending artery, right and left atrium, right and left ventricle) showed no statistically significant differences between patients with and without subclinical damage.

CONCLUSION: Our results emphasize the crucial role of cardioprotective measures in mitigating adverse effects, highlighting RT as having negligible influence on cardiac performance. An extended follow-up assessment of the whole series is warranted to determine whether a subclinical effect could significantly influence clinical outcomes and cardiac events.

PMID:39436588 | DOI:10.1007/s11547-024-01897-6

Environ Monit Assess. 2024 Oct 22;196(11):1090. doi: 10.1007/s10661-024-13232-7.

ABSTRACT

Microplastics (MPs) and heavy metal pollution pose significant environmental threat, potentially leading to agroecosystem toxicity and jeopardizing food security. Therefore, this study aims to evaluate the abundance and risk assessment of these pollutants in five different farmlands of Ernakulam district, India. Results showed that MPs content in agricultural fields near commercialized areas such as Kakkanad Nedungapuzha, Nedumbassery, and Kadamakuddy was dominant compared to Nechoor, a rural area. The average microplastic abundance was found to be 45.6 ± 26.4 items kg⁻¹ dw. Polypropylene (PP) and polyethylene (PE) were the dominant polymers found in the soil samples, constituting 45% and 25% of the microplastic content, respectively. The pollution load index of MPs indicates that the sampling sites are considered to be polluted as PLI > 1 with hazard level I. The heavy metal pollution status follows the order: Cu (80.3 to 724 mg/kg) > Zn (77 to 543.5 mg/kg) > Cr (171.65 to 334.65 mg/kg) > As (10.25 to 79.5 mg/kg) > Pb (2.05 to 30.3 mg/kg) > Cd (0.3 to 14.35 mg/kg). Calculated pollution load index (PLI) geo-accumulation index (Igeo), ecological risk assessment values indicate that commercialized regions exhibit high levels of trace metals, namely Cu, Zn, As, Cd, and Cr, posing a significant concern for the agricultural ecosystem. Our results indicate heightened microplastics and heavy metals prevalence in farmlands adjacent to commercial zones, necessitating immediate preventive action to mitigate increasing concentrations.

PMID:39436565 | DOI:10.1007/s10661-024-13232-7

Acta Neurol Belg. 2024 Oct 22. doi: 10.1007/s13760-024-02667-x. Online ahead of print.

ABSTRACT

BACKGROUND AND OBJECTIVE: Intramedullary mature teratomas in adults are rare tumors that pose significant diagnostic and therapeutic challenges due to their diverse tissue composition and intramedullary location. This review, which includes an illustrative case, aims to provide a comprehensive overview of the clinical presentation, diagnosis, treatment, and outcomes of adult intramedullary mature teratomas through a systematic review of 89 cases.

METHODS: A systematic review was conducted following PRISMA guidelines, using keyword combinations in PubMed, MEDLINE, and Web of Science databases until June 2024. Inclusion criteria were adult patients (> 18 years) with histopathologically confirmed intramedullary mature teratomas. Statistical analyses examined relationships between the extent of resection (EoR), tumor location, and patient outcomes.

RESULTS: Among the 89 cases, the mean age was 39.94 ± 13.52 years, with a male-to-female ratio of 1.39:1. Tumors were most commonly located in the conus region (51.2%). Surgical resection was the primary treatment, with 43 cases undergoing partial resection and 33 gross total resection. No statistically significant differences in outcomes were found between EoR, sex, associated anomalies, or specific outcomes. However, younger patients showed improved outcomes for lower limb weakness and sphincter dysfunction. Recurrence was noted in three cases, all located in the conus.

CONCLUSION: Intramedullary mature teratomas require a nuanced approach that balances complete resection and neurological preservation. Early diagnosis and individualized surgical planning are crucial for optimizing outcomes. Despite the challenges, effective management is achievable, and ongoing research is essential to refining treatment strategies for this rare tumor.

PMID:39436559 | DOI:10.1007/s13760-024-02667-x

Acta Neurol Belg. 2024 Oct 22. doi: 10.1007/s13760-024-02672-0. Online ahead of print.

ABSTRACT

OBJECTIVE: To evaluate the safety and efficacy of bridging intravenous thrombolysis plus mechanical thrombectomy (MT) versus direct MT in different age groups of patients with acute ischemic stroke (AIS) secondary to large vessel occlusion (LVO) of the anterior circulation.

METHODS: Consecutive patients from the prospective endovascular stroke registry of the Comprehensive Stroke Center, University of Rome Tor Vergata, Italy, between January 2015 and June 2021 were retrospectively analyzed. Patients were divided into age groups (≤ 80 years old and > 80 years old); for each age group, they were further divided in the bridging therapy group and the direct MT group. We performed a propensity score analysis according to baseline characteristics. Safety outcomes were any intracerebral hemorrhage (ICH), symptomatic ICH (sICH) and 3-month mortality. Efficacy outcomes were successful recanalization (modified Thrombolysis in Cerebral Infarction, mTICI, score ≥ 2b) and 3-month functional independence (modified Rankin Scale, mRS, ≤ 2).

RESULTS: We included 761 AIS patients with anterior circulation LVO (mean age 73.5 ± 12.8 years; 44.8% males; mean baseline NIHSS 16 ± 5). After propensity score, there were 365 patients ≤ 80 years old (52% bridging therapy) and 187 patients > 80 years old (57% bridging therapy). In both age groups of patients, we found no statistically significant differences in the rates of any ICH, sICH, successful recanalization and 3-month mortality and functional independence between bridging therapy and direct MT groups.

CONCLUSION: In our population, safety and efficacy outcomes of bridging therapy versus direct MT did not differ in both AIS patients ≤ 80 and > 80 years old.

PMID:39436555 | DOI:10.1007/s13760-024-02672-0

Head Neck Pathol. 2024 Oct 22;18(1):110. doi: 10.1007/s12105-024-01717-3.

ABSTRACT

PURPOSE: This PRISMA-guided and PROSPERO-registered systematic review aimed to summarise the current knowledge on the characteristics (clinical, radiographic, and histopathological) and treatment options for segmental odontomaxillary dysplasia (SOD).

METHODS: Descriptive studies, case series, and case reports were searched up to May 2024 in PubMed, Embase, Web of Science, SciELO, and the Cochrane Library databases. Statistical association analyses were performed on clinical variables, using chi-square tests.

RESULTS: The 35 included studies detailed 60 SOD cases in patients with a mean age of 12 ± 9.6 years. 11. Males were more frequently affected than females (62% or 1.6:1 ratio). Most cases involved the right maxilla (55%) and presented facial asymmetry and/or unilateral swelling (78%). Three cases involved both maxillae and mandible; Skin alterations were reported in 50% of the cases. Intraoral alterations such as alveolar process enlargement and gingival hyperplasia were also frequently observed (84% and 58%, respectively). All patients presented tooth alterations and 1st and/or 2nd upper premolars were absent in 80% of the cases. Dense bone and altered trabecular patterns were frequently observed in radiographs. Histopathological exams commonly showed dense trabecular bone and hyperplasic gingival tissue. Only 33 cases reported the SOD treatment, which ranged from follow-up without intervention up to surgery and orthodontics. No significant associations were found between sex and facial asymmetry or continuous lesion growth (p > 0.05). Additionally, no associations were found between intraoral alterations or symptoms and continuous lesion growth (p > 0.05).

CONCLUSION: This review presents SOD epidemiological, clinical, radiographic and histopathological data. Evidence regarding treatment is scarce.

PMID:39436514 | DOI:10.1007/s12105-024-01717-3

Egypt Heart J. 2024 Oct 22;76(1):144. doi: 10.1186/s43044-024-00576-1.

ABSTRACT

BACKGROUND: The purpose of this study is to compare the clinical results of Left Atrial Appendage Closure (LAAC) and oral anticoagulation (OAC) in individuals with AF.

METHODS: For randomized controlled trials (RCTs) comparing the clinical results of OAC to LAAC in patients with atrial fibrillation (AF), we searched PubMed, ScienceDirect, and Cochrane. The included publications were subjected to meta-analyses using Review Manager v5.4.

RESULTS: In comparison to OAC, LAAC was linked with a decreased incidence of all stroke (OR 0.68; 95% CI 0.55-0.84; p = 0.0004). LAAC was also linked to a decreased risk of hemorrhagic stroke (OR 0.20, 95% CI 0.07-0.55; p = 0.002). There is no statistically significant difference between the two groups in terms of ischemic stroke (OR 1.05; 95% CI 0.59-1.84; p = 0.88) or systemic embolization (OR 1.02; 95% CI 0.42-2.46; p = 0.97).

CONCLUSIONS: According to our meta-analysis, the LAAC was less likely than the OAC to have a complete or hemorrhagic stroke. For the two groups, however, there was no difference in the risk of ischemic stroke or systemic embolization.

PMID:39436494 | DOI:10.1186/s43044-024-00576-1

Neurosurg Rev. 2024 Oct 22;47(1):809. doi: 10.1007/s10143-024-03053-0.

ABSTRACT

Flow-diverter devices (FDs) are effective in treating intracranial aneurysms (IAs) but carry substantial periprocedural risks, particularly ischemic complications. This study aimed to determine if elevated Systemic Immune-Inflammation Index (SII) can independently predict these risks and assess the impact of age and dual antiplatelet therapy on this association. We conducted a retrospective analysis of patients treated with FDs between February 2016 and August 2023, using blood samples taken within six days before surgery to calculate SII. Logistic regression and decision tree analyses assessed the link between SII and periprocedural complications, with subgroups exploring influencing factors. Multivariable analysis identified high SII as an independent predictor of periprocedural complications (OR = 5.306, 95% CI: 1.367-18.455; P = 0.009). The decision tree model confirmed SII > 0.437 as a critical threshold. Subgroup analysis showed a pronounced association of SII with periprocedural complications in patients ≥ 65 years (OR = 36.979, 95% CI: 2.103-650.134; P = 0.014) and in those on clopidogrel plus aspirin therapy (OR = 16.921, 95% CI: 2.733-104.746; P = 0.002). An elevated Systemic Immune-Inflammation Index (SII) > 0.437 significantly correlates with increased periprocedural complications (6.5% vs. 1.8%, P = 0.017). Although not statistically significant, higher SII is associated with a greater rate of ischemic events (3.9% vs. 0.9%). Elevated preoperative SII independently predicts periprocedural complications, particularly ischemic events, in patients undergoing FDs treatment for intracranial aneurysms. This association is particularly pronounced in older patients (> 65 years) and those receiving dual therapy with clopidogrel plus aspirin. Trial Registration: ClinicalTrials.gov (NCT06446778). Registered on May 22, 2024.

PMID:39436476 | DOI:10.1007/s10143-024-03053-0

Ann Indian Acad Neurol. 2024 Oct 22. doi: 10.4103/aian.aian_305_24. Online ahead of print.

ABSTRACT

BACKGROUND AND OBJECTIVES: Functional dissociative seizures (FDS) are very common in neurology clinics, they straddle both neurology and psychiatry. In India, scarce resources and guidelines are available for effectively conveying their diagnosis and management, which leads to a substantial gap in care. We aimed to provide an instructional module for FDS, tailored to clinicians, patients, and caregivers in Hindi, to enhance communication of diagnosis and facilitate suitable management strategies.

METHODS: The instructional module development process was based on clinical settings and expert opinions. A standard translation process was performed to ensure the linguistic and cultural equivalence. Validation was carried out by a panel of 15 validators, comprising 13 neurologists and two psychiatrists, to identify key psychoeducation components and their significance. They were provided a questionnaire consisting of five questions that were related to completeness, understandability, legibility, clarification, and usefulness of educational material for clinicians, patients, and caregivers. Items were rated using a 5-point Likert scale.

RESULTS: There was agreement on four items (Q1, Q3, Q4, and Q5), whereas approximately 85% of the validators agreed on the remaining one item (Q2). The instructional module demonstrated high content validity as indicated by both item level-content validity index (0.98) and scale-level content validity index (0.97), alongside content validity ratio and modified kappa statistics.

CONCLUSIONS: The developed Hindi instructional module for FDS serves as a valuable tool to enhance the communication of FDS diagnosis and dispel misconceptions. This offers a comprehensive resource for clinicians, patients, and caregivers in India, potentially bridging gap in FDS care.

PMID:39436451 | DOI:10.4103/aian.aian_305_24

J Gastrointest Cancer. 2024 Oct 22;56(1):9. doi: 10.1007/s12029-024-01128-1.

ABSTRACT

BACKGROUND: Colorectal cancer (CRC) represents the second leading cause of cancer-related mortality worldwide, with a significant portion of patients presenting with metastatic disease at diagnosis. Resistance to initial anti-EGFR therapy, a key treatment for RAS wild-type metastatic CRC, remains a major challenge. This study aimed to assess the efficacy and safety of rechallenge with anti-EGFR therapy in patients with metastatic CRC who have progressed after prior treatments.

METHODS: A systematic search was conducted across PubMed, Web of Science, Cochrane, and Scopus. Studies were included if they were randomized controlled trials (RCTs) or observational studies involving patients with EGFR-mutated metastatic CRC who received anti-EGFR therapy as a rechallenge. Endpoints included objective response rate (ORR), disease control rate (DCR), and the incidence of adverse events. Statistical analyses were performed using the DerSimonian/Laird random effect model, with heterogeneity assessed via I² statistics. R, version 4.2.3, was used for statistical analyses.

RESULTS: Fourteen studies were included with 520 patients; 50.3% were male, and the median age was 63 years old. The median progression-free survival (mPFS) ranged between 2.4 and 4.9 months, while the median overall survival (mOS) ranged from 5 to 17.8 months. Our pooled analysis demonstrated an objective response rate (ORR) of 17.70% (95% CI, 8.58-26.82%) and a disease control rate (DCR) of 61.72% (95% CI, 53.32-70.11%), both with significant heterogeneity (I², 84% and 80%, respectively; p < 0.01). In the subgroup analysis, cetuximab showed an ORR of 18.31% (95% CI, 4.67-31.94%), and panitumumab an ORR of 10.9% (95% CI, 0.00-26.82%), while the combination of both resulted in an ORR of 29.24% (95% CI, 0.00-65.84%). For DCR, cetuximab resulted in 62.1% (95% CI, 49.32-74.87%), panitumumab in 63.05% (95% CI, 52.13-73.97%), and the combination in 60.34% (95% CI, 31.92-88.77%), all with significant heterogeneity. Adverse events included anemia (15.39%), diarrhea (4.20%), hypomagnesemia (6.40%), neutropenia (22.57%), and skin rash (13.22%).

CONCLUSIONS: Rechallenge with anti-EGFR therapy in metastatic CRC patients shows moderate efficacy with manageable safety profiles. These findings highlight the need for careful patient selection and monitoring to optimize outcomes. Further studies are warranted to refine strategies for maximizing the therapeutic benefits of anti-EGFR rechallenge.

PMID:39436445 | DOI:10.1007/s12029-024-01128-1

J Mol Model. 2024 Oct 22;30(11):380. doi: 10.1007/s00894-024-06173-y.

ABSTRACT

CONTEXT: Single-atom catalytic systems constitute an intriguing research topic due to their inherently different chemical behavior as compared to classic heterogeneous catalysts. In this study, cluster systems representing single late transition metal atoms adsorbed on anatase were constructed starting from previously generated periodic models and subjected to a density functional theory (DFT) benchmark study. The ability of different density functional approximations representing all rungs of the Jacob’s Ladder classification to accurately describe bond lengths and adsorption energies was assessed for these clusters with the aim of revealing the functional that allows to retain the structural characteristics of the initial periodic system, while also delivering reliable energetics. In this regard, our results indicate that optimisation of the clusters with the meta-GGA functionals TPSS or RevTPSS provides the lowest mean unsigned error and root-mean-square deviations with respect to the periodic models. Moreover, these functionals and, to a slightly lesser degree, PW91 were also found to provide adsorption energies that are statistically the least deviating from the CCSD(T) reference data. More complex hybrid functionals appear to be performing less well.

METHODS: Cluster geometries were determined at the Kohn-Sham DFT level using the LANL2DZ basis set for the transition metals and the Pople 6-31G(d) basis set for O and H. The density functional approximations considered were SVWN, PBE, BP86, BLYP, PW91, TPSS, RevTPSS, M06L, M11L, B3LYP, PBE0, M06, M06-2X, MN15, ωB97X-D, CAM-B3LYP, M11, and MN12-SX. Reference adsorption energies of the metals on the support cluster were obtained at the CCSD(T)/LANL2TZ (transition metals)/6-311 + + G(d,p)//RevTPSS/LANLD2DZ (transition metals)/6-31G*. Besides the above-mentioned functionals, energy calculations using the double-hybrid functionals, DSDPBEP86, PBE0-DH, and B2PLYP, were also performed. All adsorption energy calculations were carried out on the RevTPSS geometries.

PMID:39436438 | DOI:10.1007/s00894-024-06173-y