Tag: statistics

Hernia. 2025 Dec 20;30(1):43. doi: 10.1007/s10029-025-03547-w.

ABSTRACT

PURPOSE: The incidence of trocar site hernia (TSH) after bariatric surgery is unclear. This study aims to describe the cumulative incidence of ventral hernia surgery after laparoscopic bariatric surgery in total and by laparoscopic method (LRYGB; Roux-en-Y Gastric Bypass and LSG; Sleeve Gastrectomy).

METHODS: This was a register based observational study on patients subjected to laparoscopic bariatric surgery (LRYGB or LSG) in Sweden 2009-2019. The Scandinavian Obesity Surgery Registry (SOReg) was linked to the Swedish National Patient Register (NPR) to obtain instances of ventral hernia surgery. Nearby codes were used as proxies for TSH surgery, since a specific procedure code for TSH surgery is lacking.

RESULTS: In 64 124 patients, mean follow-up was 67 ± 36 months, LRYGB (n = 52 020) 74 ± 34 months and LSG (n = 12 104) 34 ± 22 months. Mean time between bariatric- and ventral hernia surgery was 36 ± 28 months (range 0-129). The five-year cumulative incidence of surgery for ventral hernia was 2.9% (CI 2.8-3.1). The probability of having hernia surgery was significantly higher for LRYGB compared to LSG (Breslow test, p < 0.001), still significant with differences in follow-up time accounted for (p < 0.001).

CONCLUSION: The incidence of surgery for ventral hernia after laparoscopic bariatric surgery is not negligible in this material covering over a decade of bariatric procedures. Ventral hernia surgery was more common after gastric bypass than after sleeve gastrectomy.

PMID:41420786 | DOI:10.1007/s10029-025-03547-w

Am J Cardiovasc Drugs. 2025 Dec 20. doi: 10.1007/s40256-025-00778-1. Online ahead of print.

ABSTRACT

AIMS: Residual cardiovascular risk remains substantial in patients with atherosclerotic cardiovascular disease (ASCVD) despite high-intensity statin therapy. Proprotein convertase subtilisin/kexin type 9 inhibitors (PCSK9i), including monoclonal antibodies and small-interfering RNA agents, offer additional risk reduction, yet comparative evidence across individual regimens remains limited.

METHODS AND RESULTS: We conducted a systematic review and network meta-analysis of randomized controlled trials evaluating approved PCSK9i dosages in patients with ASCVD. The primary outcome was major adverse cardiovascular events (MACE); the secondary outcomes included myocardial infarction, stroke, coronary revascularization, cardiovascular mortality, and all-cause death. A total of eight trials involving 49,847 patients were included. Evolocumab (140 mg every 2 weeks or 420 mg monthly) and alirocumab 150 mg every 2 weeks significantly reduced MACE compared with placebo (risk ratios (RR): 0.78, 95% confidence intervals (CI): 0.66-0.93 and RR: 0.47, 95% CI 0.25-0.86, respectively). Evolocumab was also associated with reductions in myocardial infarction, stroke, and revascularization. Alirocumab 150 mg demonstrated the most pronounced effect on revascularization and was superior to both evolocumab and the lower alirocumab dose in this outcome. No regimen significantly reduced cardiovascular or all-cause mortality.

CONCLUSIONS: These findings suggest that PCSK9 inhibitors are effective in ASCVD, with generally similar efficacy across agents; however, regimens achieving lower and sustained low-density lipoprotein cholesterol levels may confer greater benefit, in line with the concept that “the lower, the better.”

TRIAL REGISTRATION: PROSPERO identifier no. CRD420251022108.

PMID:41420785 | DOI:10.1007/s40256-025-00778-1

Graefes Arch Clin Exp Ophthalmol. 2025 Dec 20. doi: 10.1007/s00417-025-07054-7. Online ahead of print.

ABSTRACT

PURPOSE: This post-hoc analysis of two OTX-101 clinical trials assessed the efficacy of 0.09% ciclosporin in treating dry eye disease (DED) patients with moderate-to-severe corneal damage.

METHODS: The criteria for moderate-to-severe corneal damage were defined as a CFS total score (5 zones) of ≥ 6 or single zone ≥ 2 at baseline (modified NEI scale). 516 patients (49% of the intention-to-treat population) met these criteria at baseline. Changes in ocular surface damage (cornea and conjunctiva) and aqueous tear deficiency from baseline were determined through corneal fluorescein staining (CSF), Lissamine green staining (LGS) and Schirmer’s test without anesthesia (ST).

RESULTS: After 12 weeks of treatment with OTX-101 versus (vs.) vehicle, outcomes improved across six parameters: (I) Central CFS mean change from baseline was -0.48 vs. -0.36, p = 0.0144. (II) Total CFS corneal staining change from baseline was -2.30 vs. -1.61 p = 0.0004. (III) Improvement ≥ 50% in total CFS from baseline was 44.8% vs. 33.4% p = 0. 0010. (IV) Conjunctival damage as measured by LGS mean change from baseline was -1.61 vs. -0.99, p = 0.0006. (V) Tear production as measured by ST as percentage of eyes with ≥ 10 mm increase from baseline was 18.2% vs. 8.3% p = 0.0003, and (VI) ST mean change from baseline was +2.94 vs. +0.28 p = 0.0008.

CONCLUSION: Administration of OTX-101 0.09% leads to statistically significant improvement across six parameters in ocular surface staining and tear production in DED patients with moderate to severe corneal damage.

PMID:41420783 | DOI:10.1007/s00417-025-07054-7

Acta Neurochir (Wien). 2025 Dec 20. doi: 10.1007/s00701-025-06720-3. Online ahead of print.

ABSTRACT

PURPOSE: Stereotactic-guided biopsy remains the gold standard for diagnosing intracranial lesions not amenable to surgical resection. Frameless techniques, such as the VarioGuide® system (Brainlab AG, Munich, Germany), offer a minimally invasive alternative, typically using MRI-based navigation. However, MRI-based navigation may be affected by geometric distortions that impair targeting precision. CT imaging provides superior geometric fidelity. This retrospective analysis evaluates the accuracy of frameless stereotactic biopsies in clinical routine. Patients were grouped based on the imaging modality used for neuronavigation-either MRI-only or MRI-CT fusion-allowing secondary comparison between both approaches.

METHODS: In this retrospective cohort study, 99 patients who underwent frameless stereotactic biopsy between February 2022 and September 2024 were analysed. Patients were grouped by neuronavigation modality: CT-MRI fusion-based (n = 18) and MRI-only (n = 81). Accuracy was assessed by measuring entry and target deviations using postoperative CT. Lesion volume, depth, procedure duration, and complication rates were also evaluated.

RESULTS: Entry and targeting accuracy was comparable between groups (entry deviation: 5.2 ± 3.9 mm vs. 5.4 ± 3.0 mm, p = 0.84; target deviation: 4.2 ± 3.0 mm vs. 4.4 ± 2.7 mm, p = 0.85). Lesion volume and target depth showed no significant differences. No statistically significant differences in complication rates were observed between groups (27.8% vs. 11.1%, p = 0.14).

CONCLUSION: MRI-only and CT-MRI fusion-based frameless stereotactic biopsies showed no statistically significant difference in targeting accuracy. While CT-based registration may theoretically reduce distortion-related errors, this was not reflected in our data. The choice of imaging modality should therefore be guided by clinical context and imaging availability. Further prospective studies are needed to clarify the value of CT integration in specific clinical scenarios.

PMID:41420774 | DOI:10.1007/s00701-025-06720-3

Int Ophthalmol. 2025 Dec 20;46(1):44. doi: 10.1007/s10792-025-03886-8.

ABSTRACT

PURPOSE: To analyze adverse events related to the Ex-Press® Glaucoma Filtration Device reported in the FDA’s MAUDE database over a 10-year period.

STUDY DESIGN: A retrospective case series.

METHODS: We retrospectively reviewed 533 unique adverse event reports submitted between January 1, 2015, and November 8, 2024. Data collected included patient demographics, reporter details, device model, event type (injury vs. malfunction), problem codes, and device availability for manufacturer evaluation. Descriptive statistics summarized patterns of device and patient problems.

RESULTS: The median patient age was 72 years (range 20-94), with sex reported in 2.3% of cases. The P-50 PL model accounted for 98% of reports, followed by the P-200 PL (2%). Devices were available for evaluation in 36.8% of cases, but only 19.3% were evaluated. Reports were 61% injuries and 39% malfunctions. A total of 440 device-related and 457 patient-related problems were identified. The most common device problems were displacement (31.4%) and flow obstruction (26.8%). Among patient problems, increased intraocular pressure (27.6%) and iris contact (22.3%) were most frequent. Injuries predominated in 2015-2016 (73.7%), shifting to malfunctions from 2020 to 2024 (76.9%).

CONCLUSIONS: Adverse events involving the Ex-Press® device primarily include injuries and malfunctions, with device displacement and flow obstruction being most common. The observed shift likely reflects changes in device use and surveillance rather than true safety changes. Despite limitations of passive reporting, these findings offer valuable real-world insights that complement clinical trial data and highlight the utility of the FDA’s MAUDE database as a tool for post-market surveillance. This approach can be replicated for other ophthalmic devices to enhance long-term safety monitoring and inform clinical decision-making.

PMID:41420769 | DOI:10.1007/s10792-025-03886-8

Clin Oral Investig. 2025 Dec 20;30(1):19. doi: 10.1007/s00784-025-06695-6.

ABSTRACT

OBJECTIVE: The current study aimed to evaluate the speech outcome of primary Furlow palatoplasty with buccal myomucosal flap (FPBF) versus two flap palatoplasty (TFP) in patients with cleft palate.

MATERIALS AND METHODS: Thirty patients with cleft palate were included in the current study. Fifteen patients received the primary FPBF as the surgical palatal repair technique, while the other 15 patients received the primary TFP as their cleft palate repair. All surgeries were done by a single surgeon at the age of 9-12 months. Speech assessment was done at the age of 4-8 years, including the amount of hypernasality, speech intelligibility, compensatory misarticulation, and nasopharyngoscopy VP valve competence.

RESULTS: Statistically significant improvements were detected in the 4 assessment methods while comparing primary FPBF versus the TFP groups’ scores.

CONCLUSION: Primary FPBF might be able to improve the speech outcome in comparison to TFP in patients with cleft palate. CLINICAL SIGNIFICANCE: Primary FPBF improves the amount of hypernasality, speech intelligibility, compensatory misarticulation, and nasopharyngoscopy VP valve competence. Accordingly, it limits the need for further VP repair surgeries.

TRIAL REGISTRATION: Clinicaltrials.gov (NCT06856330).

PMID:41420755 | DOI:10.1007/s00784-025-06695-6

J Cancer Res Clin Oncol. 2025 Dec 20;152(1):17. doi: 10.1007/s00432-025-06400-w.

ABSTRACT

PURPOSE: With increasing reliance on large language models (LLMs) for health information, this study evaluated reliability and quality, understandability, actionability, readability and misinformation risk of responses from LLMs to oral health concerns and oral side effects in head and neck cancer (HNC) patients.

METHODS: Frequently asked questions on oral health and HNC therapy side effects were identified via ChatGPT-GPT-4-turbo and Gemini-2.5 Flash, then submitted to eight LLMs (ChatGPT-GPT-4-turbo, Gemini-2.5 Flash, Microsoft Copilot, Perplexity, Chatsonic, Mistral, Meta AI-Llama 4, DeepSeek-R1). Responses were assessed using DISCERN and modified DISCERN instruments (reliability and quality), Patient Education Materials Assessment Tool (PEMAT [understandability and actionability]), Flesch-Reading-Ease-Score (FRES [readability]), misinformation score, citations, and wordcounts. Statistical analysis was done by Scheirer-Ray-Hare-test followed by Dunn’s post-hoc-tests and Bonferroni-Holm correction (p < 0.05).

RESULTS: A total of 40 questions belonging to 12 oral health-related categories were identified. Statistically significant differences between LLMs were found for DISCERN, modified DISCERN, PEMAT-understandability, PEMAT-actionability, FRES, and word counts (p < 0.001). Median DISCERN and modified DISCERN scores amounted from 47.0 (ChatGPT-GPT-4-turbo) to 59.0 (Perplexity, Chatsonic) and from 2.0 (Gemini-2.5 Flash, Mistral) to 5.0 (Perplexity) indicating good to fair reliability. LLMs were understandable (median PEMAT-understandability scores ≥ 75.0), but provided limited specific guidance (median PEMAT-actionability scores ≤ 40) and used complex language (median FRES ≤ 40.2). Misinformation risk was generally low and not statistically significant among LLMs (p = 0.768).

CONCLUSION: Despite a low overall misinformation risk, deficits in actionability highlight the need for cautious integration of LLMs into HNC patient education.

PMID:41420748 | DOI:10.1007/s00432-025-06400-w

Naunyn Schmiedebergs Arch Pharmacol. 2025 Dec 20. doi: 10.1007/s00210-025-04644-4. Online ahead of print.

ABSTRACT

BACKGROUND: Vitamin D regulates cell growth and differentiation, encourages pro-apoptotic effect, stimulates antiangiogenic effect, and affects both innate and adaptive immunity. However, serum vitamin D level could differ between countries according to geographic, genetic, and dietary factors.

AIM OF THE WORK: Cosidering that most studies of relations between vitamin D level and breast cancer were conducted outside Africa and considering the fact that populations differ in sun exposure, dietary habits, and genetic construction, this study aimed to investigate the relationship between serum levels of vitamin D3 and vitamin D- binding protein (VDBP) with pathological response, clinicopathological characteristics, and various biological markers in Egyptian breast cancer patients undergoing neoadjuvant chemotherapy (NACT).

METHODS: A total of 71 female breast cancer patients (mean age: 57 years) were enrolled in this prospective observational study. Fasting blood samples were collected 1 day before and 3 months after initiation of NACT. Serum levels of vitamin D3 and V DBP were quantified using high-performance liquid chromatography (HPLC) and enzyme-linked immunosorbent assay (ELISA), respectively. Tumor expression of Ki-67, HER2, progesterone receptor (PR), and estrogen receptor (ER) was assessed via immunohistochemistry. Serum levels of CA 15-3 and Bcl-2 were also measured.

RESULTS: Complete pathological response (pCR) was achieved in 44 patients (68.7%). A statistically significant increase in both vitamin D3 and VDBP levels was observed following NACT (p < 0.001). Lower pre- and post-treatment levels of vitamin D3 and VDBP were significantly associated with postmenopausal status, higher tumor grade and stage, triple-negative breast cancer subtype, and high Ki-67 expression (p < 0.001). Conversely, higher levels were significantly associated with achieving pCR (p < 0.001). Both vitamin D3 and VDBP levels demonstrated a significant negative correlation with tumor stage and grade (p < 0.001). Among different clinical and laboratory parameters, only triple-negative subtype and baseline vitamin D were significantly predictive for pCR by multivariable analysis (OR 1.488 and 0.506, respectively) and (95% CI 1.109-1.825 and 0.331-0.75, respectively).

CONCLUSION: Serum levels of vitamin D3 and VDBP significantly increased after NACT and were associated with favorable clinicopathological features and pCR. Only triple-negative subtype and baseline vitamin D were significantly predictive for pCR by multivariable analysis. These findings suggest that vitamin D3 and VDBP may serve as potential prognostic indicators in breast cancer management.

PMID:41420735 | DOI:10.1007/s00210-025-04644-4

Stem Cell Rev Rep. 2025 Dec 20. doi: 10.1007/s12015-025-11035-y. Online ahead of print.

ABSTRACT

BACKGROUND: Steroid-induced osteonecrosis of the femoral head (SONFH) is a progressive and refractory orthopedic disorder characterized by deterioration of the subchondral bone microstructure and eventual femoral head collapse, leading to hip joint dysfunction. Current therapeutic strategies offer limited efficacy and fail to reverse the necrotic process, with approximately 70% of patients eventually requiring total hip arthroplasty. Therefore, developing novel treatments capable of halting disease progression and promoting bone repair is crucial for addressing this clinical challenge. Exosomes, bioactive nanovesicles that regulate apoptosis, angiogenesis, and inflammation, represent a promising regenerative modality. In particular, stem cell-derived exosomes are considered to play a key role in the treatment of SONFH by promoting osteogenesis and angiogenesis and modulating inflammatory responses. However, the efficacy and mechanisms underlying exosome-based therapy for SONFH have not been systematically evaluated. A comprehensive synthesis of current evidence is urgently needed to inform future clinical translation.

PURPOSE: By synthesizing preclinical evidence, this study explored the mechanism and therapeutic potential of stem cell-derived exosomes in SONFH and identified key methodological limitations to provide a roadmap for future research.

STUDY DESIGN: Systematic review and meta-analysis.

METHODS: A comprehensive literature search was conducted in PubMed, Web of Science, the Cochrane Library, and Embase for preclinical studies published from database inception until August 2025, with a focus on exosome-based therapy for osteonecrosis of the femoral head. Studies meeting the predefined inclusion criteria were rigorously selected and assessed for methodological quality, and relevant data were extracted. All the statistical analyses were performed via Review Manager (RevMan) version 5.4 software.

RESULTS: A total of 12 studies were included, all of which involved rat models of SONFH. The results of the meta-analysis revealed that exosome intervention significantly increased bone mineral density (BMD), thickness of trabecula, percentage of bone mass, the number of trabecula, vascular length, vascular volume and vascular area and reduced trabecular bone dissociation.

CONCLUSION: Exosomes rescue SONFH through multiple pathways. By promoting angiogenesis and osteogenesis, they effectively reverse the core pathological process of femoral head necrosis.

PMID:41420719 | DOI:10.1007/s12015-025-11035-y

Eur J Pediatr. 2025 Dec 20;185(1):29. doi: 10.1007/s00431-025-06663-y.

ABSTRACT

The MOBAK-KG battery is a widely used tool for assessing motor skills in kindergartens. However, no normative data exists for Spanish-speaking children in Spain. The purpose of this study was two-fold: to develop normative reference values for the MOBAK-KG battery stratified by sex and age in children aged 4-6 years and to evaluate the factorial structure of the MOBAK-KG battery. This cross-sectional study enrolled 375 Spanish children (51.5% female). Smoothed percentile for object-movement, self-movement, and total MOBAK-KG scores were calculated using the LMS method, incorporating the γ-lambda, μ-mu, and δ-sigma parameters according to age and sex, and confirmatory factor analysis was performed to determine the construct validity. Fit indices and parameter estimates were reported. The MOBAK-KG battery (observable items) that cover the object movement and self-movement motor competencies (latent factors) were consistently higher in boys than in girls and increased across age groups for both sexes. The results confirm the structure of the one-factor model provided the best representation of the data (χ²/df ratio = 1.09, CFI = 0.997; RMSEA = 0.016), and the structure of the two-factor model in all sections of the MOBAK battery also demonstrated acceptable fit (χ²/df = 1.33, CFI = 0.972; RMSEA = 0.036).

CONCLUSION: This is the first study to provide normative MOBAK-KG data for preschool children in Spain, based on a representative sample from Northern Spain. Our results suggest that the MOBAK-KG is a valid tool to assess fundamental motor competence in children in Spain. These normative data provide pediatricians and educators with objective benchmarks to identify children at risk of motor deficits.

WHAT IS KNOWN: • Fundamental motor skills (FMS) are essential for children’s development and for sustaining lifelong physical activity. • MOBAK-KG is a validated tool for preschool motor competence, but normative data and structure have mainly come from German/Swiss cohorts, limiting use in Spain.

WHAT IS NEW: • We provide the first Spanish norms for MOBAK-KG (ages 4-6) and confirm its psychometric structure: the one-factor model fits best, while the two-factor (OM/SM) solution remains useful for domain profiling. • We quantified age-related gains and modest sex differences and provided percentile cut-offs to support screening and early pediatric assessment and intervention.

PMID:41420717 | DOI:10.1007/s00431-025-06663-y