Tag: statistics

J Biomater Appl. 2026 Jun 6:8853282261459552. doi: 10.1177/08853282261459552. Online ahead of print.

ABSTRACT

Significant craniomaxillofacial (CMF) bone defects after trauma, tumor removal, or congenital disabilities are a major clinical challenge. Therefore, new methods are continually sought to improve treatment effectiveness. In this context, next-generation biomaterials deserve special attention. Sericin, a protein component of silk, demonstrates regenerative potential. Current evidence suggests that sericin actively stimulates osteogenesis by promoting the differentiation of osteoprogenitor cells and upregulating key markers, including Runx2, osteocalcin, and osteopontin. In addition, it exhibits a favorable biocompatibility profile and promising immunomodulatory properties. By exerting anti-inflammatory effects, sericin may promote a pro-healing polarization of M2 macrophages and reduce TNF-α expression. The antimicrobial potential of sericin-based biomaterials is also highlighted, though the evidence remains debated and further validation is needed, particularly for grafts and scaffolds used in CMF regeneration. Sericin also appears to promote angiogenesis and the organized deposition of mineralized extracellular matrix, which are crucial factors in bone regeneration. In preclinical animal models, sericin-based biomaterials have shown statistically significant improvements in the healing of calvarial, alveolar, and long bone defects. Despite these encouraging findings, the translation of sericin into clinical practice remains limited, with only two human studies available, primarily for minor applications in oral surgery. This review summarizes the current literature focusing on sericin-based biomaterials and relates the available evidence to potential applications in CMF regeneration. In a structured manner, it begins with the physical and biological properties of sericin, proceeds to cellular and tissue interactions, and presents preclinical and clinical evidence, critically evaluating the advantages and limitations.

PMID:42250217 | DOI:10.1177/08853282261459552

Clin Rheumatol. 2026 Jun 6. doi: 10.1007/s10067-026-08177-w. Online ahead of print.

ABSTRACT

BACKGROUND: Gout is increasingly recognized as a systemic metabolic and inflammatory disorder. The urate paradox-where uric acid shifts from a plasma antioxidant to an intracellular pro-oxidant-remains a clinical challenge in managing systemic complications.

OBJECTIVE: This study evaluates the association between systemic oxidative stress imbalance and high-sensitivity C-reactive protein (hs-CRP) as a marker of inflammatory burden in gouty patients.

METHODS: A case-control study was conducted on 200 participants (100 gouty patients and 100 healthy controls) in Yemen. Biomarkers including malondialdehyde (MDA), total antioxidant capacity (TAC), glutathione (GSH), and hs-CRP were quantified. Multivariate linear regression was used to assess the independent predictive value of MDA for hs-CRP.

RESULTS: Gouty patients exhibited significantly elevated MDA (6.45 ± 1.55 nmol/mL) and hs-CRP (14.2 ± 5.1 mg/L) compared to controls (P < 0.001). Conversely, a profound depletion in TAC and GSH was observed. A statistically significant positive correlation (r = 0.78, P < 0.001) was observed between MDA and hs-CRP. In multivariate analysis, MDA remained a significant independent associate, explaining approximately 61% of the variance in hs-CRP levels (R² = 0.61, P < 0.001).

CONCLUSION: Gout is characterized by a significant systemic oxidative stress imbalance which is independently associated with systemic inflammation. Clinical management should transcend urate-lowering therapy to include strategies aimed at restoring antioxidant capacity to mitigate systemic inflammatory damage. Key Points • Gouty patients exhibit a profound state of systemic redox exhaustion, characterized by depleted antioxidant defenses. • Lipid peroxidation (MDA) is strongly associated with the systemic inflammatory burden (hs-CRP) in gouty cohorts. • The robust correlation between oxidative stress and inflammatory markers suggests their potential as biomarkers for assessing disease status. • Systemic inflammation in gout appears to be closely linked to the severity of oxidative stress imbalance.

PMID:42250201 | DOI:10.1007/s10067-026-08177-w

Clin Rheumatol. 2026 Jun 6. doi: 10.1007/s10067-026-08193-w. Online ahead of print.

ABSTRACT

OBJECTIVE: To critically examine current statistical practices for handling missing data in fibromyalgia randomized controlled trials (RCTs) and to provide practical guidance for the implementation of linear mixed models (LMMs).

METHODS: This methodological and narrative perspective reviews recent RCTs in fibromyalgia, highlighting common limitations in the handling of missing data and longitudinal analyses. We contrast traditional approaches, such as repeated-measures ANOVA, with LMM-based strategies within the intention-to-treat (ITT) framework. Additionally, we provide a step-by-step guide for implementing LMMs in SPSS.

RESULTS: Evidence indicates that many fibromyalgia RCTs continue to rely on suboptimal statistical methods, including the exclusion of participants with incomplete data and the use of ANOVA-based approaches. These practices may reduce consistency with the ITT principle, decrease statistical efficiency, and contribute to potentially biased treatment effect estimates. In contrast, LMMs can incorporate partially observed longitudinal data, explicitly model within-subject correlations, and accommodate unbalanced longitudinal designs under the Missing At Random (MAR) assumption. However, their validity depends on correct model specification and the plausibility of underlying assumptions.

CONCLUSIONS: The persistent gap between methodological recommendations and analytical practices in fibromyalgia RCTs may compromise the interpretability and reliability of treatment effect estimates. LMMs may represent a more flexible and methodologically appropriate approach for longitudinal analyses involving incomplete follow-up data, particularly when aligned with study design characteristics and available statistical expertise. Improving statistical rigor in this field remains essential to support more reliable clinical interpretation and evidence-informed decision-making.

PMID:42250200 | DOI:10.1007/s10067-026-08193-w

Int Microbiol. 2026 Jun 6. doi: 10.1007/s10123-026-00849-6. Online ahead of print.

ABSTRACT

BACKGROUND: The need to develop alternative treatment approaches to acne vulgaris and other skin infections is becoming increasingly urgent due to the rising prevalence of antibiotic resistance in Cutibacterium acnes (a key pathogen related to such conditions). Nanoparticles (NPs) have shown great potential as antimicrobial agents that could improve the effectiveness of traditional antibiotics when administered together. This research examines antibacterial activity of silver NPs (Ag-NPs) and zinc oxide NPs (ZnO-NPs), both independently and when used collaboratively with common anti-acne antibiotics used to treat C. acnes.

METHODS: Ag-NPs and ZnO-NPs were biosynthesized using aqueous Peganum harmala extract as a reducing and stabilizing agent. The synthesized nanoparticles were characterized using UV-Vis spectroscopy, X-ray diffraction (XRD), scanning/transmission electron microscopy (SEM/TEM), and dynamic light scattering (DLS). This research examined two C. acnes clinical isolates (P1 and P2) and one reference strain (NCTC747) were used in this research. Broth microdilution assays were employed to determine minimum inhibitory concentrations (MICs). Checkerboard assays and fractional inhibitory concentration index (FICI) analysis were performed to explore synergy between antibiotics and NPs.

RESULTS: A successful formation of spherical Ag-NPs and hexagonal ZnO-NPs has been confirmed, with average crystallite sizes of approximately 13-14 nm and 53-55 nm, respectively. Both Ag-NPs and ZnO-NPs were found to exhibit strong antibiotic activity. The MICs of the tested antibiotics were significantly reduced when used in combination with AgNPs. The reduction was up to 2-8 fold compared to antibiotic monotherapy. Moreover, most Antibiotic-Ag-NPs combinations exhibited synergistic interactions in the FICI analysis (FICI ≤ 0.5). Meanwhile, there are increased moderate effects resulted from the ZnO-NP combinations. The Antibiotic MIC generally values reduced two-to-four-fold. The relevant FICI values suggested that the interactions were primarily additive (FICI ≈ 0.75), although there was some evidence of strain-dependent variations. A two-way ANOVA test showed that the MIC values reductions for both antibiotics and nanoparticles were statistically significant (p < 0.001).

CONCLUSION: The potential of biosynthesized NPs as adjunct therapeutic agents for the management of acne-associated infections was suggested by their promising antibacterial and antibiotic-enhancing effects against C acnes.

PMID:42250195 | DOI:10.1007/s10123-026-00849-6

Dermatol Ther (Heidelb). 2026 Jun 6. doi: 10.1007/s13555-026-01808-9. Online ahead of print.

ABSTRACT

INTRODUCTION: In June 2023, the US Food and Drug Administration (FDA) approved ritlecitinib (50 mg once daily) for treatment of severe alopecia areata (AA) in patients ≥ 12 years. This study aimed to assess the characteristics of patients prescribed ritlecitinib within the first 10 months following approval.

METHODS: This retrospective study analyzed data from the Komodo Healthcare Map^® (Komodo) and OMNY Health Foundation databases. Patients were aged ≥ 12 years with ≥ 1 ritlecitinib prescription on or after June 23, 2023, ≥ 1 AA diagnoses on or before index date (first prescription date), and ≥ 12 months of continuous enrollment before study entry. Two cohorts were assessed: patients with Komodo data (cohort 1) and linked Komodo and OMNY data (cohort 2). Clinical characteristics and AA treatment history were assessed over the 12-month pre-index period and stratified by age (12-17 and ≥ 18 years).

RESULTS: Cohort 1 included 2562 patients; of these, 61.8% were prescribed ritlecitinib by a dermatologist, 58.9% were female, and 35.2% were adolescents. Approximately 24% had alopecia totalis/alopecia universalis as the closest diagnosis prior to index, 12.4% had ≥ 1 other autoimmune disorder, 23.9% had ≥ 1 atopic disorder, and 23.7% had ≥ 1 diagnosis of a mental health condition captured. In cohort 1 during the 12 months before index date, 26.6% of patients received no AA treatments, 31.9% received systemic immunomodulators, and 31.3% received injectable corticosteroids. Cohort 2 included 381 patients; of those in cohort 2 with reported disease location, hair loss primarily occurred on the scalp (90.5%) and face (43.2%). In cohort 2, 77.2% of patients with a scalp hair loss (SHL) assessment had ≥ 50% SHL.

CONCLUSIONS: In the first 10 months following US approval, ritlecitinib was prescribed to a broad range of patients, including those with and without prior treatments and comorbidities. This suggests that ritlecitinib may provide new opportunities to engage or re-engage patients in AA-directed care.

PMID:42250189 | DOI:10.1007/s13555-026-01808-9

Clin Transl Oncol. 2026 Jun 6. doi: 10.1007/s12094-026-04388-4. Online ahead of print.

ABSTRACT

BACKGROUND: Tattoo inks may contain carcinogenic compounds, and pigment migration to lymphatic tissues raises concerns regarding potential cancer risk. Epidemiological evidence remains inconclusive.

OBJECTIVES: To assess the association between tattoo exposure and the incidence of skin cancer and hematological malignancies.

METHODS: PubMed, Embase, and the Cochrane Library were searched from inception to January 2026 for cohort and case-control studies comparing cancer incidence in tattooed versus non-tattooed adults. Random-effects meta-analyses using restricted maximum-likelihood estimators were performed to pool odds ratios (ORs) with 95% confidence intervals (CIs). Heterogeneity was quantified using I² statistics. Risk of bias was assessed using ROBINS-E, and certainty of evidence was evaluated with GRADE. Leave-one-out sensitivity analyses were conducted.

RESULTS: Seven observational studies including 140,841 participants were analyzed. Tattoo exposure was not associated with overall skin cancer (OR 0.92; 95%CI 0.83-1.04; I² = 0%; p = 0.179). Stratified analyses by number of tattoo sessions showed no significant associations: one session (OR 1.08; 95%CI 0.55-2.12; I² = 92.4%), two-to-three sessions (OR 0.90; 95%CI 0.62-1.32; I² = 63.2%), and ≥ 4 sessions (OR 0.70; 95%CI 0.29-1.70; I² = 88.5%). For hematological malignancies, pooled analysis showed no significant association (OR 1.02; 95%CI 0.78-1.32; I² = 64.9%; p = 0.910). Subtype analyses were non-significant: non-Hodgkin lymphoma (OR 1.00; 95%CI 0.73-1.36; I² = 3.7%), Hodgkin lymphoma (OR 1.19; 95%CI 0.59-2.40; I² = 91.7%), diffuse large B-cell lymphoma (OR 0.90; 95%CI 0.57-1.44; I² = 61.7%), T-cell lymphoma (OR 1.07; 95%CI 0.61-1.88; I² = 0%), and follicular lymphoma (OR 0.99; 95%CI 0.72-1.36; I² = 1.9%). Sensitivity analysis excluding one influential study rendered the association for overall hematological malignancies statistically significant (OR 1.20; 95%CI 1.05-1.39; I² = 0%). Certainty of evidence ranged from low to moderate.

CONCLUSIONS: Tattoo exposure was not associated with increased skin cancer risk and showed no significant association with hematological malignancies in primary analyses. A significant association emerged only after sensitivity analysis, warranting cautious interpretation and further prospective investigation.

PMID:42250187 | DOI:10.1007/s12094-026-04388-4

Eur J Orthop Surg Traumatol. 2026 Jun 6;36(1):215. doi: 10.1007/s00590-026-04813-y.

ABSTRACT

OBJECTIVES: To evaluate the effectiveness and safety of intrawound vancomycin powder in the definitive surgical management of high-risk fractures, with particular attention to postoperative infection, microbiological profile, and adverse events.

METHODS: Data Sources: A systematic search of PubMed, EMBASE, Web of Science, Cochrane Library and Scopus was conducted in February 2025, with a search cut-off date of January 31, 2025 following PRISMA framework.

STUDY SELECTION: Randomized and observational comparative studies evaluating intrawound vancomycin powder in patients undergoing definitive fracture fixation were included if they reported postoperative infection, microbiological outcomes, or adverse events.

DATA EXTRACTION: Two reviewers independently screened studies, extracted data, and assessed methodological quality using the Cochrane Risk of Bias 2 (RoB 2) tool for randomized trials and ROBINS-I for non-randomized studies.

DATA SYNTHESIS: Random-effects models were used to estimate pooled odds ratios (ORs) with 95% confidence intervals (CIs). Statistical heterogeneity was assessed using the I² statistic.

RESULTS: Eight studies involving 3185 patients were included, of whom 1149 received topical vancomycin powder. Vancomycin use was associated with a significant reduction in postoperative infection following fracture fixation (OR 0.59, 95% CI 0.42-0.82; p = 0.002; I² = 0%). Microbiological data were limited; however, one study reported a lower proportion of gram-positive infections in the vancomycin group, with no corresponding reduction in gram-negative infections. Two studies contributed to an exploratory pooled safety analysis, which showed no statistically significant difference in adverse events between groups (OR 1.39, 95% CI 0.95-2.02; p = 0.38; I² = 0%).

CONCLUSIONS: The certainty of evidence was limited by risk of bias, outcome indirectness, and the inclusion of non-randomized studies. Intrawound vancomycin powder was associated with a reduced risk of postoperative infection in high-risk fracture fixation without a statistically significant increase in reported adverse events. Microbiological findings remain sparse and should be interpreted cautiously. These results suggest that intrawound vancomycin powder may represent a useful prophylactic adjunct in selected orthopaedic trauma cases, although further high-quality studies are required to clarify its safety profile and microbiological consequences.

LEVEL OF EVIDENCE: II.

PMID:42250185 | DOI:10.1007/s00590-026-04813-y

Matern Child Health J. 2026 Jun 6. doi: 10.1007/s10995-026-04273-0. Online ahead of print.

ABSTRACT

INTRODUCTION: Hypertensive disorders of pregnancy (HDP) are associated with substantial maternal morbidity and mortality. The purpose of this study was to describe demographic and clinical factors that differ between American Indian/Alaska Native (AI/AN) and White women with HDP in North Dakota.

METHODS: We conducted a retrospective descriptive analysis of resident, in-state, singleton births among AI/AN and White women with HDP using 2007-2020 North Dakota birth records from the Division of Vital Records. Descriptive analyses were performed using summary statistics and bivariate comparisons to compare demographic risk factors and maternal outcomes between AI/AN and White women with HDP. Annual trends in HDP diagnoses were also analyzed.

RESULTS: From 2007 to 2020, the prevalence of HDP increased significantly from 4.4% to 12.1%. The prevalence increased significantly among both AI/AN women (6.6% to 13.6%, p < 0.001) and White women (4.1% to 11.9%, p < 0.001). Compared with White women, AI/AN women had higher rates of cesarean delivery (45.3% vs. 38.5%, p < 0.001), cesarean delivery after a trial of labor (30.5% vs. 23.1%, p < 0.001), preterm birth (23.1% vs. 17.0%, p < 0.001), fetal macrosomia (3.2% vs. 1.3%, p < 0.001), and blood transfusion (2.2% vs. 1.2%, p = 0.009). AI/AN women had lower rates of third- or fourth-degree perineal laceration (0.4% vs. 1.6%, p = 0.004) and cephalic presentation at delivery (91.9% vs. 94.9%, p < 0.001).

CONCLUSION FOR PRACTICE: HDP increased significantly from 2007 to 2020 among both AI/AN and White women in North Dakota. Among pregnancies complicated by HDP, AI/AN women experienced higher rates of several adverse maternal and delivery outcomes. These findings highlight the need for targeted and culturally responsive strategies to improve maternal outcomes among AI/AN women.

PMID:42250178 | DOI:10.1007/s10995-026-04273-0

Arch Orthop Trauma Surg. 2026 Jun 6;146(1):210. doi: 10.1007/s00402-026-06352-x.

ABSTRACT

INTRODUCTION: Surgical stabilization of Pauwels Type III femoral neck fractures remains a significant challenge due to high vertical shear forces. While the medial buttress plate is a recognized solution, it requires extensive deep dissection. This study aims to compare the biomechanical performance of various screw configurations combined with either a medial buttress or anteromedial support plate.

MATERIALS AND METHODS: Twenty-five third-generation synthetic femurs were used to create a standardized 70-degree (Pauwels III) fracture model. Specimens were divided into five groups (n = 5): (A) Inverted triangle (IT) screws with a Pauwels screw, (B) Inverted triangle (IT) with medial buttress plate (MBP), (C) Inverted triangle with anteromedial support plate (ASP), (D) L-configuration with medial buttress plate (MBP), and (E) L-configuration with anteromedial support plate (ASP). Axial loading was applied at 2 mm/min until construct failure, defined objectively by the real-time force-distance curve.

RESULTS: Although no statistically significant difference was found between groups (p = 0.102), a large effect size was observed (η² = 0.309). Group C (IT + ASP) demonstrated the highest mean failure load (1695 ± 494.6 N). Conversely, Group E (L-configuration + ASP) exhibited the lowest stability (977.2 ± 195.4 N) with a remarkably narrow standard deviation. The majority of failures occurred as transverse subtrochanteric fractures distal to the implants.

CONCLUSION: The combination of an inverted triangle screw arrangement with an anteromedial support plate demonstrated comparable biomechanical stability to the medial buttress plate, while offering a potentially safer surgical corridor. Conversely, pairing L-shaped screw configurations with anteromedial support plates resulted in the lowest mean ultimate load-to-failure among the tested constructs, likely due to potential stress riser effects.

PMID:42250173 | DOI:10.1007/s00402-026-06352-x

Environ Monit Assess. 2026 Jun 6;198(7):691. doi: 10.1007/s10661-026-15538-0.

ABSTRACT

This investigation aims to assess surface soil contamination by heavy metals in the new city of Ali Mendjeli (Constantine, Algeria). The methodological approach is based on energy-dispersive X-ray fluorescence (EDXRF), associated with multivariate statistical tools and pollution indices (enrichment factor (EF), geo-accumulation index ( $I_{\mathrm{geo}}$ ), and contamination factor (CF)), in order to characterize the contamination levels and identify potential sources of pollution. X-ray fluorescence spectrometry analysis revealed the presence of trace metallic elements. These mainly consist of the following elements: chromium, zinc, nickel, and lead, with average concentrations exceeding the limit values set by the AFNOR U44-04 regulations. Moreover, no copper contamination was observed. The EF values indicate moderate pollution for Ni, Cr, Pb, and Zn, and low pollution for Cu. Meanwhile, the positive values of $I_{\mathrm{geo}}$ varied between 0 and 2 for Cr, Ni, Zn, and Pb indicate low to moderate contamination, confirming the consistency between the pollution indices. On the other hand, the CF values for Cr, Zn, Ni, and Pb, ranging between 1 and 6, indicate moderate to high contamination, mainly of anthropogenic origin. Principal component analysis (PCA), coupled with hierarchical clustering (HC), indicates that the main sources of heavy metal contamination come from agricultural activities, metallurgical industries, gravel quarries, waste incineration, and road traffic.

PMID:42250167 | DOI:10.1007/s10661-026-15538-0