Categories
Nevin Manimala Statistics

Quantitative Analysis of the O-RADS Classification Using Ultrasound Scoring Method (USM) and Its Application Significance

J Clin Ultrasound. 2025 Oct 11. doi: 10.1002/jcu.70092. Online ahead of print.

ABSTRACT

OBJECTIVE: This study aimed to quantify the O-RADS classification using the ultrasound scoring method (USM) and explore its clinical application value.

METHODS: A retrospective analysis was conducted on 205 patients with adnexal tumors (unilateral or bilateral), corresponding to 244 tumor cases, admitted to our hospital from 2018 to 2023. This cohort included 100 patients with malignant tumors (122 malignant lesions, comprising 34 borderline tumors, and 6 malignant tumors of the fallopian tubes) and 105 patients with benign tumors (122 benign lesions). All cases were confirmed by preoperative ultrasound examination and postoperative pathology. A senior ultrasound physician performed the O-RADS classification, while another ultrasound physician applied the USM. The scores were manually assigned, and the sensitivity, specificity, and area under the curve (AUC) of the USM and O-RADS classification in the differential diagnosis of adnexal tumors were determined through ROC curve analysis. The Delong test was used in R to compare the diagnostic performance of the two diagnostic methods. The optimal range of scores between different categories of O-RADS was calculated using by ROC curve.

RESULTS: The sensitivity, specificity, and AUC of the USM (when the optimal cut-off value was ≥ 14 points) in the differential diagnosis of adnexal tumors were 0.951, 0.877, and 0.975 (95% CI: 0.960-0.990). The sensitivity, specificity, and AUC of O-RADS classification (when the optimal cut-off value was ≥ 4 categories) in the differential diagnosis of adnexal tumors were 0.984, 0.887, and 0.973 (95% CI: 0.955-0.992). The AUC comparison between O-RADS classification and USM revealed no statistically significant difference (p = 0.87, p > 0.05).

CONCLUSIONS: Both the USM and the O-RADS classification exhibit high diagnostic efficacy in the differential diagnosis of adnexal tumors. The quantification of O-RADS categories using the USM provides a more intuitive and convenient approach, suitable for ultrasound physicians at all levels. This method demonstrates strong generalizability and can effectively guide clinical diagnosis and treatment.

PMID:41074610 | DOI:10.1002/jcu.70092

Categories
Nevin Manimala Statistics

Three-Dimensional-Printed Porous Tantalum Wedge Shows Promising Early Results for Opening-Wedge High Tibial Osteotomy: A Retrospective Comparative Study With Mean 50-Month Follow-Up

Orthop Surg. 2025 Oct 11. doi: 10.1111/os.70173. Online ahead of print.

ABSTRACT

PURPOSE: Bone void fillers are essential for successful outcomes in opening-wedge high tibial osteotomy (OWHTO), a procedure that corrects varus knee misalignment and alleviates medial compartment pain. However, the best filler for OWHTO is still uncertain. This study compared the clinical and radiographic results of using three-dimensional-printed (3DP) porous tantalum wedges versus allogeneic chip bone as fillers in OWHTO, aiming to provide a reference for clinical decision-making.

METHODS: This exploratory-retrospective matched-cohort consecutively enrolled study included 20 patients (10 per group) who were treated between January 2020 and December 2022, with Group A (3DP porous tantalum) selected from a large trial and Group B (allogeneic chip bone) matched by age, gender, and varus severity.

INCLUSION CRITERIA: young, active patients with tibial varus and complete follow-up; exclusions: knee infection, instability, contracture, dislocation, or pan-compartmental osteoarthritis. Postoperatively, early full-weight-bearing rehabilitation was applied, with follow-ups at 6 weeks, 3 months, 6 months, 12 months, and annually.

PRIMARY OUTCOME: bone healing (modified van Hemert score, standing radiographs).

SECONDARY OUTCOMES: hospital for special surgery knee score (HSS), visual analogue scale (VAS), time to full-weight-bearing walking, and radiographic parameters (joint line convergence angle [JLCA], femur-tibia angle [FTA], hip-knee-ankle angle [HKA], mechanical medial proximal tibial angle [mMPTA], mechanical axis deviation [MAD], weight-bearing line [WBL] ratio, posterior tibial slope [PTS]). Postoperative complications were recorded and compared between both groups. Statistical analyses used the Mann-Whitney U test for continuous data and the chi-square test for categorical data.

RESULTS: Mean age was 48.7 ± 3.9 years, with a mean follow-up of 50.0 ± 7.0 months (range: 29.4-59.0). Group A had significantly higher bone healing scores at 6 weeks, 3 and 6 months (3.0 ± 0.8 vs. 1.6 ± 1.0, 3.4 ± 0.5 vs. 2.0 ± 0.9, 4.3 ± 0.5 vs. 2.9 ± 0.9, respectively, all p < 0.01), with no difference at 1 year (4.8 ± 0.4 vs. 4.4 ± 0.5, p = 0.075). Time to full-weight-bearing walking was significantly shorter in Group A (18.7 ± 3.2 vs. 54.4 ± 15.3 days; p < 0.001). Both groups showed significant postoperative improvements in VAS, HSS scores, and radiographic parameters (MAD, WBL ratio, mMPTA, HKA; all p < 0.01 vs. preoperative values), with no intergroup differences in these metrics (preoperative or postoperative). Overall complication rates were similar (20% vs. 60%; p = 0.074), but Group A had a lower incidence of delayed union (0% vs. 40%; p = 0.011). The statistical power for 1-year bone union grades was 0.65 (G*Power, effect size = 0.883).

CONCLUSION: 3DP porous tantalum wedges in OWHTO accelerate bone healing (up to 6 months), reduce time to full-weight-bearing walking, and lower delayed union rates compared to allogeneic chip bone, thereby establishing them as a promising option for future surgical interventions. Further large-scale, long-term trials are needed to confirm these benefits.

PMID:41074606 | DOI:10.1111/os.70173

Categories
Nevin Manimala Statistics

How people with aphasia describe themes depicted in grid and visual scene displays

Augment Altern Commun. 2025 Oct 11:1-12. doi: 10.1080/07434618.2025.2567054. Online ahead of print.

ABSTRACT

This within-groups, repeated measures study examined differences in how accurately people with aphasia (PWA) described themes depicted in AAC displays (theme description accuracy), the types of descriptions they produced (action, naming, or combined action and naming messages), and their display preferences when viewing grids and visual scene displays (VSDs). Nineteen adults with aphasia participated in this study. Each participant viewed grids and VSDs with matched content (e.g., people, objects) presented on a computer monitor and described themes presented in each display. They then completed a display preference task. Results revealed that participants described VSDs themes correctly more often than grid themes; however, grids were described with partial correctness more often than VSDs. Additionally, both display types were described using verbs or verb phrases (action messages), more frequently than nouns or noun phrases (naming messages); however, VSDs were described using action messages more often than grids. Participants also reported greater preference for VSDs than grids. Study results support existing research that both grids and VSDs can effectively support communication for adults with aphasia; however, they may differ in their ability to represent action and naming messages. In addition, results indicate that PWA may prefer VSDs over grids.

PMID:41074599 | DOI:10.1080/07434618.2025.2567054

Categories
Nevin Manimala Statistics

Acceptable Nomenclature for Pregnancy Loss Care: A Cross-Sectional Observational Survey

BJOG. 2025 Oct 11. doi: 10.1111/1471-0528.70057. Online ahead of print.

ABSTRACT

OBJECTIVE: To conduct a pilot study evaluating the acceptability of pregnancy loss nomenclature among people with recent lived experience and make recommendations for UK mass communication.

DESIGN: Electronic internet-based questionnaire.

SETTING: UK.

POPULATION OR SAMPLE: Service users who accessed UK healthcare for > 1 experience(s) of pregnancy loss between 2021 and 2024 (n = 391).

METHODS: Descriptive and inferential statistics.

MAIN OUTCOME MEASURES: Acceptability ratings for pregnancy loss nomenclature used diagnostically in UK healthcare settings.

RESULTS: Much nomenclature currently in use in UK pregnancy loss care was rated ‘unacceptable’ by a majority of study participants. Spontaneous abortion, incompetent cervix, and cervical incompetence were among the terminology rated as ‘unacceptable’ by > 80.0% of the respondents rating terms for the process of loss. In contrast, pregnancy loss and ectopic pregnancy were rated ‘acceptable’ by > 80.0% of respondents. As nomenclature for pregnancy loss outcomes, products, contents of the womb/uterus, and tissue were rated ‘unacceptable’ by > 80.0% of respondents. Baby and ‘their given name’ were rated ‘acceptable’ by > 80.0% of respondents across all gestational age brackets. Some terminology elicited mixed acceptability ratings.

CONCLUSIONS: Some pregnancy loss nomenclature attracted consensus acceptability or unacceptability ratings for respondents. The data inform evidence-based recommended alternatives, which should be adopted for mass communications relating to pregnancy loss.

PMID:41074593 | DOI:10.1111/1471-0528.70057

Categories
Nevin Manimala Statistics

Electronic Patient File-Embedded Model-Informed Precision Dosing Compared with Physician Dosing of Tacrolimus in Kidney Transplantation

Clin Pharmacol Ther. 2025 Oct 11. doi: 10.1002/cpt.70090. Online ahead of print.

ABSTRACT

Model-informed precision dosing (MIPD) of tacrolimus in renal allograft recipients, evaluated in silico, demonstrated improved (time to and) probability of target concentration attainment and smaller deviations from target range. Using simulated tacrolimus concentration-time profiles, a study of 200 patients was predicted to have sufficient power to demonstrate superior performance of MIPD for these exposure end points compared with physician-based dosing. A fully automated tacrolimus MIPD application integrated in the electronic patient file was tested in 293 de novo recipients in the first 14 days after transplantation in a prospective randomized controlled clinical validation study. More patients dosed with the MIPD application reached the primary study end point of three in-target tacrolimus pre-dose trough concentrations by Day 8, compared with physician-dosed patients: 52.2% (95% CI: 45.3-59.6) vs. 35.7% (95% CI: 27.4-45.6); HR: 1.64 (95% CI: 1.10-2.43) (P = 0.015). The mean fraction of samples per patient in target during the complete study period was higher in the MIPD arm: 0.38 ± 0.14 compared with the physician-dosed arm: 0.28 ± 0.14 (P < 0.001). The mean distance from target window was significantly lower in MIPD-treated patients: 0.022 (95% CI: 0.019-0.024) vs. 0.040 (95% CI: 0.036-0.044) (P < 0.001). On 19 occasions (< 1%), MIPD tacrolimus dose suggestions were actively overruled by physicians. A fully automated MIPD application for tacrolimus in de novo renal recipients, integrated in the electronic patient file, demonstrated superior performance in achieving tacrolimus exposure targets with limited active overruling of MIPD dose executions by physicians. Automated MIPD can be tested in larger trials to evaluate the impact of dosing decision support on clinical outcomes after renal transplantation.

PMID:41074581 | DOI:10.1002/cpt.70090

Categories
Nevin Manimala Statistics

Comparative Efficacy of Janus Kinase Inhibitors Indicated for Severe Alopecia Areata: A Bayesian Network Meta-Analysis and Matching-Adjusted Indirect Comparison

J Dermatol. 2025 Oct 11. doi: 10.1111/1346-8138.17959. Online ahead of print.

ABSTRACT

Systemic Janus kinase inhibitors (JAKIs) have markedly advanced the therapeutic landscape for alopecia areata (AA). Although baricitinib and ritlecitinib are approved in the United States (US) and Europe, and deuruxolitinib in the US for severe AA, the lack of head-to-head randomized controlled trials (RCTs) limits evidence-based prescribing decisions. Moreover, prior meta-analyses excluded data on certain oral JAKIs or incorporated findings from agents and dosing regimens that were abandoned, investigational, clinically ineffective, or associated with unacceptable safety profiles. To compare the efficacy of oral JAKIs, limited to FDA, EMA, or MHRA approved drugs and doses-baricitinib (2 and 4 mg QD), ritlecitinib (50 mg QD), and deuruxolitinib (8 mg BID)-for severe AA, using advanced indirect comparison methodologies. A systematic review was performed following PRISMA 2020 guidelines (CRD420251116775). Bayesian network meta-analysis (NMA) synthesized data from RCTs reporting Week 24 outcomes on Severity of Alopecia Tool (SALT) ≤ 10 and SALT ≤ 20 thresholds. Multilevel network meta-regression (ML-NMR) evaluated heterogeneity and adjusted for baseline imbalances. Additionally, unanchored matching-adjusted indirect comparisons (MAIC) were conducted using individual patient-level data from THRIVE trials. Surface under the cumulative ranking (SUCRA) values were calculated to rank treatments. Seven RCTs (n = 4560 participants) were included. Deuruxolitinib 8 mg significantly outperformed baricitinib 2 and 4 mg on both SALT endpoints. Differences with ritlecitinib 50 mg were directionally favorable for deuruxolitinib but not statistically significant in NMA and ML-NMR models. MAICs confirmed superior odds for deuruxolitinib versus baricitinib 2 mg (OR = 71.55) and ritlecitinib (OR = 18.27) for SALT ≤ 20. SUCRA rankings also consistently favored deuruxolitinib. Among approved oral JAKIs, deuruxolitinib 8 mg shows the highest short-term efficacy for severe AA. These findings provide preliminary evidence to guide treatment decisions but should be interpreted as exploratory pending confirmation.

PMID:41074562 | DOI:10.1111/1346-8138.17959

Categories
Nevin Manimala Statistics

Artificial Intelligence Assisted Thermal Imaging for Gingival Inflammation Assessment: A Novel Approach

J Esthet Restor Dent. 2025 Oct 11. doi: 10.1111/jerd.70045. Online ahead of print.

ABSTRACT

BACKGROUND: The integration of thermal imaging with artificial intelligence (AI) offers a novel, non-invasive approach for assessing gingival inflammation. While thermal imaging has been widely applied in other medical fields, its use in evaluating gingival health remains largely unexplored. This study is the first to utilize AI-supported analysis of thermal gingival images in patients with mouth breathing habits, aiming to detect and classify gingival inflammation severity. This research establishes specific thermal thresholds for gingival health and disease in this unique population.

METHODS: Forty participants were included, stratified according to periodontal status and clinically confirmed breathing pattern (mouth or nasal breathing), under standardized imaging conditions. From these participants, 160 images were annotated, producing 1734 labeled data points categorized according to bleeding on probing (BoP) for diagnosis, with Gingival Index (GI) applied only for secondary stratification of inflammation severity. Preprocessing included image resizing, outlier removal, and calculation of mean RGB values. The XGBoost algorithm was used for classification, with hyperparameters optimized via grid search and 5-fold cross-validation to ensure robust model performance.

RESULTS: The XGBoost Achieved Outstanding Classification Results, With an Accuracy of 92.74%, Precision of 92.95%, Sensitivity of 92.74%, and an F1 Score of 92.78%. Cross-Validation Confirmed the Model’s Reliability, With Mean-Test and Validation-Scores of 88.28% and 89.43%, Respectively.

CONCLUSIONS: This study represents the first application of AI-supported thermal imaging for evaluating gingival inflammation in mouth breathers, marking a significant step forward in periodontal diagnostics. By establishing specific thermal thresholds in this unique population, it highlights the potential of this innovative approach as a non-invasive, real-time, and scalable diagnostic tool. Future research should focus on refining AI algorithms and expanding datasets to enhance clinical applicability, paving the way for advanced diagnostics and personalized care in periodontology.

PMID:41074551 | DOI:10.1111/jerd.70045

Categories
Nevin Manimala Statistics

The efficacy and safety of doravirine/lamivudine/tenofovir disoproxil fumarate in treatment-naïve and treatment-experienced patients with HIV

Ann Med. 2025 Dec;57(1):2564286. doi: 10.1080/07853890.2025.2564286. Epub 2025 Oct 11.

ABSTRACT

BACKGROUND: Doravirine (DOR) has demonstrated good efficacy for the treatment of people with HIV (PWH); however, there is limited real-world research in developing countries.

METHODS: We retrospectively assessed the efficacy and safety of DOR/lamivudine (3TC)/tenofovir disoproxil fumarate (TDF) at 24 and 48 weeks in treatment-naïve and treatment-experienced PWH.

RESULTS: A total of 83 PWH were included from January 1, 2022, to December 31, 2023. The median age was 40 years (32-54). Twenty-seven patients (32.5%) were treatment-naïve PWH, and 56 patients (67.5%) were treatment-experienced PWH, the most common switch was from integrase inhibitors (37/56) to DOR, followed by efavirenz (18/56) and nevirapine (1/56). In treatment-naïve PWH, the median CD4+ T-cell count was 222.9 ± 144.2 cells/mL at baseline, which increased to 337.8 ± 189.6 cells/μL at week 24 (p < 0.001) and to 431.6 ± 259.9 cells/μL at week 48 (p < 0.001). The overall VS rate was 76.9% (20/26) at week 24 and 93.3% (14/15) at week 48. Creatinine (Cr) significantly increased from baseline to week 48 (p = 0.013) but remained normal. There were no significant differences observed in BMI, glucose, estimated glomerular filtration rate (eGFR), liver enzymes, or plasma lipid levels between the baseline and follow-up data. In treatment-experienced PWH, there were no significant changes in the VS rate, CD4+ T-cell count, Cr, eGFR or liver enzymes between the baseline and follow-up data. However, compared to baseline, statistically significant reductions in plasma lipids were observed at week 24 and at week 48. There was also a significant decrease observed in BMI at week 48 compared with baseline. In addition, anxiety, depression and sleep disorders improved in those patients who switched regimens from efavirenz to DOR.

CONCLUSIONS: We provide a short-term observational report of the efficacy and safety of DOR/3TC/TDF in routine clinical practice, further supporting its use in PWH.

PMID:41074542 | DOI:10.1080/07853890.2025.2564286

Categories
Nevin Manimala Statistics

A Novel Hybrid Software-Assisted Method to Evaluate Quantitatively Corneal Endothelium From Light Microscopy Images

Microsc Res Tech. 2025 Oct 11. doi: 10.1002/jemt.70079. Online ahead of print.

ABSTRACT

Light (LM) and specular microscopies (SM) are standard techniques used by eye banks during corneal endothelial cell density (ECD) and morphology evaluation. This study aimed to develop a novel Hybrid method (HY) that integrates the benefits of both SM and LM while minimizing their drawbacks. A total of 283 endothelial images from LM and SM were analyzed from 31 corneas. For HY analysis, LM images were processed using SM-dedicated software to semi-automatically determine ECD, CV% (coefficient of variation), and HEX% (hexagonality). Agreements between LM, SM, and HY, as well as inter-operator bias, were assessed using the Bland-Altman analysis. Evaluability of corneas with LM, SM, and HY was recorded during 311 examinations on 70 corneas. HY agreed with SM in ECD determination, while LM differed from HY (bias: 134 cells/mm2) and SM (bias: 115 cells/mm2). HY showed agreement with SM in HEX% determination, while a bias of 3.4% was observed in CV%. Inter-operator variability analysis showed significant differences in LM evaluations (ECD, EC morphology score). For HY, no significant inter-operator bias was obtained in ECD and HEX%, whereas CV% displayed a significant bias (3.1%). Corneal evaluability was significantly higher in LM and HY (both 96.5%) than in SM (72.7%). HY enabled quantitative ECD and morphology investigation of corneal endothelia using LM-obtained images. HY, SM, and LM techniques statistically agreed in ECD and morphology examinations, or showed clinically acceptable bias. The HY method demonstrated lower inter-operator variability than LM and higher evaluability than SM.

PMID:41074540 | DOI:10.1002/jemt.70079

Categories
Nevin Manimala Statistics

The Current Status of Adult Patients With Urea Cycle Disorders in Japan: From the Nation-Wide Study

J Inherit Metab Dis. 2025 Nov;48(6):e70099. doi: 10.1002/jimd.70099.

ABSTRACT

Urea cycle disorders (UCDs) are rare inherited metabolic diseases characterized by defective detoxification of nitrogen, leading to hyperammonemia and neurological complications. While pediatric UCDs have been extensively studied in Japan, data on adult patients remain limited. This study aims to evaluate the current status of Japanese adult UCD patients, hereby comparing long-term outcomes after neonatal/infantile or late onset in a new nationwide study investigating clinical manifestations and management. In total, we collected data of 116 adult UCD patients diagnosed and/or treated at various institutions, combining this new cohort (34 UCD patients between January 2010 and December 2022) with data from a previous nationwide study (82 UCD patients between January 2000 and March 2018). Among 116 adult UCD patients, ornithine transcarbamylase deficiency was the most common subtype (N = 69). Hyperammonemia occurred in 91.4% of patients, and intellectual disability was present in 50.0%. Patients generally showed reduced final height and BMI compared to Japanese controls, particularly among females and those with infantile-onset UCDs. Peak ammonia levels ≥ 360 μmol/L were significantly associated with intellectual disability. Liver transplantation (LT) was performed in 20 patients, and although it helped to avoid hyperammonemia, it did not statistically improve neurocognitive outcomes in patients with peak ammonia < 360 μmol/L. This study provides the first comprehensive overview of adult UCD patients in Japan, highlighting frequent growth impairment and variable cognitive outcomes. LT improves metabolic control but cannot prevent intellectual disability in all patients. These findings underscore the need for early diagnosis, individualized treatment strategies, and long-term follow-up into adulthood.

PMID:41074536 | DOI:10.1002/jimd.70099