Tag: statistics

Front Med (Lausanne). 2026 May 19;13:1819360. doi: 10.3389/fmed.2026.1819360. eCollection 2026.

ABSTRACT

INTRODUCTION: Pediatric medical device development remains limited, particularly for rare and complex conditions such as cyanotic congenital heart disease (CCHD). Although advances in surgery and diagnostics have improved survival, continuous and non-invasive monitoring of metabolic and physiological deterioration is not available outside hospital settings. Wearable devices could address this gap, but their clinical adoption requires alignment with real-world needs, usability, and healthcare workflows. This study aimed to capture clinician perspectives to inform the early development of a wearable multiparametric biosensor for pediatric CCHD within the European OrphaDev4Kids project (EU4H-2023-PJ).

METHODS: A structured, web-based anonymous survey was distributed through EPTRI channels to reach pediatric cardiology experts across Europe, including members of the OrphaDev4Kids Clinical Expert Committee. The questionnaire addressed current monitoring practices in CCHD, unmet clinical needs, usability and compliance, data integration, training requirements, and data governance. Quantitative responses were analyzed using descriptive statistics, and qualitative feedback was descriptively reviewed.

RESULTS: Clinicians reported that current CCHD monitoring relies mainly on imaging and basic physiological parameters, with minimal assessment of metabolic markers and no availability of non-invasive metabolic monitoring. Infancy, both before and after heart surgery, was identified as the most critical phase for remote monitoring. Respondents strongly supported non-invasive, multiparametric wearable devices providing threshold-based alerts and longitudinal summaries rather than continuous data streams. Comfort, intuitive design, and minimal disruption to daily activities were key determinants of patient compliance, while integration with clinical workflows, training, and technical support were essential for adoption. Clinicians also emphasized the importance of secure, regulation-compliant data handling. Despite limited familiarity with advanced wearable devices, clear and consistent expectations regarding functionality and usability emerged.

CONCLUSION: This expert consultation identifies a clear unmet need and strong clinical support for the development of wearable, multiparametric biosensors tailored to pediatric patients with CCHD. The findings provide actionable guidance for device design and highlight the importance of combining technological innovation with human-centered design, workflow integration, and robust data governance to enable future clinical adoption.

PMID:42239944 | PMC:PMC13226199 | DOI:10.3389/fmed.2026.1819360

J Hand Microsurg. 2026 May 21;18(4):100475. doi: 10.1016/j.jham.2026.100475. eCollection 2026 Jul.

ABSTRACT

BACKGROUND: Pyogenic flexor tenosynovitis (PFT) is a common hand infection associated with significant morbidity. Management varies due to lack of evidence-based guidelines, typically involving surgery and antibiotics. We conducted a cohort study, comparing outcomes between different surgical methods to see if one is optimal.

METHODS: Retrospective data collection of patients who underwent surgery for PFT in a single tertiary plastic surgery unit between 21 August 2013 and 4 October 2023 was undertaken. Demographics, injury mechanism, operative details and antibiotic use were recorded. Cases involving cellulitis or osteomyelitis were excluded. Outcomes included length of stay, length of follow-up and post-operative complications. Multivariable regression analyses were performed, adjusting for age, diabetes and smoking status.

RESULTS: A total of 174 patients (mean age 47.2 years [SD 18.7]) were included. PFT most commonly resulted from animal bites (23.7% of cases). There was wide variation in antibiotic prescribing practice. Open surgery was performed in 121 cases, whilst 53 underwent minimally invasive procedures. No statistically significant differences in outcomes were observed between techniques in unadjusted or adjusted analyses. Diabetes was associated with an increased likelihood of requiring further procedures on multivariable analysis.

CONCLUSION: There is no evidence of differing outcomes for open or minimally invasive techniques. Diabetes may be associated with a requirement for further procedures. However, these results should be interpreted in the context of the retrospective design, missing data and potential for confounding by indication. Standardised, evidence-based management guidelines are required, with prospective multi-centre studies needed to better define optimal treatment strategies.

PMID:42239939 | PMC:PMC13227196 | DOI:10.1016/j.jham.2026.100475

Med Devices (Auckl). 2026 May 29;19:595863. doi: 10.2147/MDER.S595863. eCollection 2026.

ABSTRACT

PURPOSE: Uncontrolled bleeding remains a major surgical challenge, increasing morbidity, operative time, and costs, highlighting the need for effective adjunctive hemostats. Veriset is a synthetic, absorbable patch that promotes clotting and provides mechanical hemostasis. While early studies show efficacy, real-world evidence across diverse settings is needed. This post-market, multicenter study evaluated the safety and effectiveness of Veriset in various surgical procedures.

METHODS: This observational, single-arm, prospective study was nested within Medtronic’s product surveillance registry. Sites were selected for procedural diversity (cardiovascular, soft-tissue, solid-organ), high Veriset use, and clinical study experience. Patients treated with Veriset as part of usual care were followed for 30 days post-procedure to monitor adverse events (AEs). The primary safety and effectiveness endpoints were device-related AEs within 30 days and hemostasis within 5 minutes, respectively. Secondary outcomes included time to hemostasis, length of hospital stay, and bleeding-site severity. Results were summarized using descriptive statistics and exact (Clopper-Pearson) confidence intervals.

RESULTS: Veriset was used on-label in 100 patients in cardiovascular (56), soft-tissue (18), solid-organ (18), and other (8) procedures. Most were performed via open surgery (90.0%), with 34% involving anastomoses. Median blood loss was 600 mL (interquartile range 200-1500), with transfusions in 24 patients. Of the 120 bleeding sites treated, pre-Veriset methods included sutures (55.8%, 67/120) and pressure (29.2%, 35/120). Bleeding was mostly mild/moderate (82.5%, 99/120). Device-related AEs occurred in 1 patient, with no deaths. Hemostasis within 5 minutes was achieved at 91.7% (110/120) of sites and in 96.0% (96/100) of patients. Median time to hemostasis was 2.0 minutes; median hospital stay was 7 days.

CONCLUSION: This study provides real-world evidence that Veriset is safe and suggests that it may be an efficacious and rapid adjunct for surgical hemostasis, including in high-risk cardiovascular and solid-organ procedures, supporting and extending prior trial data for routine clinical use.

CLINICALTRIALSGOV IDENTIFIER: NCT01524276, Dec 24, 2025.

PMID:42239929 | PMC:PMC13228841 | DOI:10.2147/MDER.S595863

Saudi Med J. 2026 Feb;47(2):283-290. doi: 10.15537/1658-3175.1009. Epub 2026 Feb 7.

ABSTRACT

OBJECTIVE: To investigate the risk factors, clinical manifestations, and treatment outcomes in patients with Primary Bone Sarcomas (PBS).

METHODS: This retrospective study included all patients with PBS treated between June 2016 and December 2023 at King Abdulaziz Medical City, excluding patients with incomplete data, presence of other malignancies, diagnosis at autopsy, or unknown metastasis. Data were analyzed using SPSS software version 27. A p-value of less than 0.05 was considered statistically significant. Log Rank test was used for survival analysis.

RESULTS: The study included 127 patients. Common past medical history included diabetes (7%), hypertension (5.5%), and metastasis at presentation (15%). Joint pain (76%) and bone swelling (75%) were common clinical presentations. The median overall survival was 5 years, with a 42% mortality rate. The presence of diabetes, hypertension, high Charlson score, high histological grading, and metastasis were more common among patients with osteosarcoma than other types (p < 0.05). Significant predictors of mortality included older age (HR: 1.03, p = 0.009), metastasis at presentation (HR: 8.19, p = 0.042), and metastasis (HR: 2.92, p = 0.010). Male gender (HR: 0.47, p = 0.020) had a lower risk of mortality.

CONCLUSION: This study highlights the significant burden of PBS in Saudi Arabia. Key risk factors such as age and metastasis at diagnosis significantly impact survival, underscoring the necessity for improved surveillance and follow-up strategies. Further research is needed to develop effective, risk-stratified treatment to improve outcomes for patients.

PMID:42239909 | PMC:PMC13227453 | DOI:10.15537/1658-3175.1009

Front Oncol. 2026 May 19;16:1732883. doi: 10.3389/fonc.2026.1732883. eCollection 2026.

ABSTRACT

BACKGROUND: Colon cancer incidence is increasing globally, yet its spatial and temporal dynamics in Central Asia remain insufficiently studied. This study aimed to assess regional disparities and temporal trends of colon cancer incidence in Kazakhstan from 2005 to 2024 using geospatial and age-period-cohort analyses.

METHODS: A nationwide population-based study was conducted using data from the Unified Nationwide Electronic Health System of Kazakhstan. Crude incidence rates (CR) and age-standardized incidence rates (ASR) were calculated per 100,000 population using the WHO world standard population. Spatial patterns were assessed based on the administrative division of 2005, and clustering was evaluated using the Getis-Ord Gi* statistic. Temporal trends were analyzed using Joinpoint regression and Age-Period-Cohort analysis modeling, including estimation of net drift, local drift, and period and cohort rate ratios.

RESULTS: The national CR was 9.64 per 100,000, and the ASR was 9.44 per 100,000. A persistent north-south gradient was observed, with higher incidence in northern and central regions (Pavlodar, Kostanay, Karaganda, North Kazakhstan, Astana) and lower rates in southern regions. Spatial clustering analysis identified significant hotspots in northern regions and coldspots in the south. Age-Period-Cohort analysis demonstrated a strong age effect across all models. The net drift was +0.57% per year (95% CI 0.23-0.91; p=0.001), with the highest increases observed in older age groups (65-84 years). Period and cohort effects were also significant, indicating the influence of demographic aging, healthcare changes, and generational risk factors.

CONCLUSION: Colon cancer incidence in Kazakhstan is characterized by pronounced spatial disparities and is primarily driven by population aging. The combined geospatial and Age-Period-Cohort analysis approach provides a comprehensive framework for understanding disease dynamics and supports the development of targeted cancer control strategies.

PMID:42239894 | PMC:PMC13225997 | DOI:10.3389/fonc.2026.1732883

Front Oncol. 2026 May 19;16:1761654. doi: 10.3389/fonc.2026.1761654. eCollection 2026.

ABSTRACT

BACKGROUND: Chemoradiotherapy (CRT) is the standard treatment for squamous cell carcinoma of the anal canal (ACC), achieving excellent local control and sphincter preservation. However, many long-term survivors experience persistent bowel, urinary, sexual, and psycho social sequelae affecting quality of life (QoL). The PROACT study (Patient – Reported Outcomes in Anal Cancer Patients Treated with Intensity-Modulated Radiotherapy; NCT06364579) wants to explore the relationship between oncologic outcomes and patient-reported QoL in the era of modern radiotherapy.

METHODS: This single-institution ambispective study included patients with a diagnosis of ACC treated between 2011 and 2024 with intensity modulated radiotherapy (IMRT)-based CRT, followed-when indicated-by an image guided interventional radiotherapy (IRT) boost. Oncologic outcomes and toxicity were assessed using standard criteria. QoL was evaluated annually up to 5 years post-treatment using the EORTC QLQ-C30 and anal cancer-specific QLQ-ANL27 questionnaires. Statistical analyses explored associations between QoL domains and patient-, disease-, and treatment-related factors.

RESULTS: Median age was 62 years (range 34-83); 82.2% were female. Median follow-up was 51 months. Three- and five-year overall survival were both 97.5%. Disease-free survival was 88.2% and 84.5% at three and five years, respectively, while locoregional relapse-free survival was 92.8% and 89.0%. Colostomy-free survival showed identical rates at three and five years (97.3%). Late≥ G3 Gastrointestinal toxicity occurred in 6 patients (6.7%). Compared with the general population, both sexes reported significantly higher global QoL (males p = 0.002; females p = 0.001), while diarrhea was worst in women (p = 0.0008). Younger age (<70 years), female sex, and late GI toxicity correlated with poorer functional outcomes, particularly in bowel and sexual domains.

CONCLUSIONS: PROACT underscores that treatment success in anal cancer extends beyond cure, encompassing survivorship, functionality, and well-being. Integrating oncologic and patient-reported outcomes offers a comprehensive, patient-centered framework for optimizing long-term care.

PMID:42239889 | PMC:PMC13225979 | DOI:10.3389/fonc.2026.1761654

Front Oncol. 2026 May 19;16:1738955. doi: 10.3389/fonc.2026.1738955. eCollection 2026.

ABSTRACT

BACKGROUND/OBJECTIVES: Large Language Models (LLMs) are increasingly used in medicine for tasks ranging from patient communication to exam preparation. This study aimed to evaluate the feasibility of using a domain-specific, out-of-training-data radiation and cancer biology examination as a benchmarking framework for large language models, and to compare the accuracy and consistency of commonly used LLMs available at the time of data collection.

METHODS: GPT-3.5, GPT-4, and Llama-2 were queried with 335 multiple-choice questions (MCQs) from the 2023 American Society for Radiation Oncology (ASTRO) Radiation and Cancer Biology Exam Study Guide, excluding image-based items. Each model answered all questions five times over three months to evaluate consistency. Model responses were scored against the official answer key and analyzed using one-way ANOVA with Bonferroni correction to determine statistical differences in accuracy.

RESULTS: GPT-4 achieved the highest accuracy, correctly answering 81% of questions, significantly outperforming GPT-3.5 (62%) and Llama-2 (51%) (p < 0.001). All models performed worse on questions requiring calculations, though differences were not statistically significant. In terms of reliability, GPT-4 and Llama-2 provided consistent responses more frequently than GPT-3.5. Despite stable overall scores, all models exhibited variability in individual responses across repeated trials. GPT-4 produced the longest explanations, averaging 183 words per answer.

CONCLUSIONS: This study demonstrates the feasibility of using a domain-specific, out-of-training-data examination to benchmark large language model knowledge in radiation and cancer biology. While performance differences were observed among models, variability and limitations, particularly in calculation-based questions, highlight the importance of methodological benchmarking and cautious interpretation when considering medical educational applications.

PMID:42239883 | PMC:PMC13225992 | DOI:10.3389/fonc.2026.1738955

J Clin Aesthet Dermatol. 2026 Apr;19(4):35-37.

ABSTRACT

OBJECTIVE: To compare thyrotropin (TSH) levels across nonscarring alopecia (NSA) subtypes-alopecia areata (AA), telogen effluvium (TE), and androgenetic alopecia (AGA)-in a primary analysis of all patients, a secondary analysis of euthyroid patients stratified into low-normal (0.5-2.5 mIU/L) and high-normal (2.5-4.5 mIU/L) categories, and a tertiary analysis of patients with thyroid dysfunction.

METHODS: A retrospective chart review was conducted on patients diagnosed with AA, TE, or AGA at a single academic dermatology department between August 2017 and August 2024. TSH values were drawn within 3 months of the initial visit, and patient demographics were extracted from the electronic medical record. Patients with thyroid dysfunction were excluded from the secondary analysis. TSH values within the euthyroid range were stratified into low-normal and high-normal categories. A tertiary analysis of patients with frank thyroid dysfunction was later conducted. Descriptive statistics, Kruskal-Wallis tests, and Bonferroni-corrected pairwise comparisons were performed.

RESULTS: Among the 1,411 patients initially identified, most TSH values were within the euthyroid range. In a secondary analysis of 1,291 euthyroid patients, there was no significant difference in TSH distribution across NSA subtypes, including when stratified into low-normal vs high-normal categories. Among patients with thyroid dysfunction (8.5%), those with TE had the highest relative proportions of both hypothyroidism (5.0%) and hyperthyroidism (5.5%). Black or African American patients with AA and TE had lower mean TSH levels than White patients; however, this was not observed in AGA.

LIMITATIONS: Limitations of this study include the retrospective design and the potential for incomplete or biased medical records.

CONCLUSION: TSH levels among patients with NSA did not vary significantly based on NSA subtype. Racial differences in mean TSH were observed in AA and TE, but the clinical significance remains uncertain.

PMID:42239846 | PMC:PMC13229151

Ment Health Clin. 2026 Jun 2;16(3):129-134. doi: 10.9740/mhc.2026.06.129. eCollection 2026 Jun.

ABSTRACT

INTRODUCTION: Lithium has long been considered the gold standard mood stabilizer in the treatment of acute mood episodes related to bipolar (BD) and schizoaffective disorder. Previous research has primarily focused on lithium loading strategies and their effects on symptom severity and inpatient length of stay (LOS). However, less is known about specific prescribing practices at lithium initiation that may influence LOS.

METHODS: This retrospective study aimed to evaluate three initiation-related prescribing factors of lithium and their association with changes in LOS among adult inpatients experiencing acute mood episodes of BD or schizoaffective disorder. The factors were lithium initiation within 48 hours of admission, achieving a therapeutic level-producing dose within 48 hours of admission, and receiving intensive initial lithium dosing (≥900 mg/day). The Mann-Whitney U test was used to assess statistical significance. The timing of antipsychotic coprescribing in mania was also evaluated.

RESULTS: Sixty-eight patients were included in this study. Lithium initiation within 48 hours of admission significantly decreased hospital LOS (7.2 vs 13.4 days; P < 0.001). Lithium optimization to a dose that produced a therapeutic drug level within 48 hours of admission also significantly decreased LOS (6.2 vs 9.1 days; P < 0.01). Intensive initial dosing did not significantly affect LOS. Of patients with mania, 51.5% were trialed on antipsychotics before starting lithium.

CONCLUSION: Early lithium initiation and optimization in patients with acute bipolar mood episodes significantly reduced hospital LOS. Prospective studies are needed to address potential confounders to confirm whether early lithium optimization directly reduces LOS.

PMID:42239829 | PMC:PMC13229530 | DOI:10.9740/mhc.2026.06.129

Front Aging Neurosci. 2026 May 19;18:1806505. doi: 10.3389/fnagi.2026.1806505. eCollection 2026.

ABSTRACT

BACKGROUND: Parkinson’s disease (PD) involves progressive dopaminergic neuron loss in the substantia nigra (SN). Aldehyde dehydrogenase 1A1 (ALDH1A1), the rate-limiting enzyme in retinoic acid biosynthesis, is enriched in vulnerable dopaminergic neuron subpopulations and is consistently downregulated in PD. However, the relationship between ALDH1A1 expression and broader dopaminergic pathway gene co-expression has not been systematically characterized across multiple independent datasets.

METHODS: Gene expression correlations were analyzed across seven independent human SN microarray datasets (n = 156; 70 controls, 86 PD) from the Gene Expression Omnibus. Simple arithmetic means across datasets are reported as the primary summary statistic; random-effects meta-analysis with DerSimonian-Laird estimation was applied to Fisher’s z-transformed correlation coefficients to generate pooled estimates with heterogeneity statistics. Marker gene-based enrichment scoring using published cell type markers from single-nucleus RNA-seq profiling of human substantia nigra-with all target genes excluded from signatures-was performed across six analyzable datasets. Selectivity of ALDH1A1 correlation attenuation was assessed using permutation testing (n = 5,000) as the primary statistical test, with parametric tests reported as supplementary.

RESULTS: In controls, ALDH1A1 showed strong co-expression with dopaminergic genes (mean r = 0.92-0.93 for TH, DDC, and SLC18A2). In PD, these correlations were attenuated (mean Δr = -0.336 for ALDH1A1-dopamine pairs). Dopamine-dopamine correlations showed less attenuation (mean Δr = -0.143). Marker gene-based enrichment scoring confirmed significant depletion of ALDH1A1-positive vulnerable dopaminergic neurons in 4 of 6 datasets. After adjusting for estimated cell type enrichment, the selectivity of ALDH1A1 attenuation was preserved (adjusted selectivity: -0.210, increased from raw selectivity of -0.190; raw permutation p = 0.0052).

CONCLUSION: ALDH1A1 co-expression with dopaminergic pathway genes is attenuated in PD substantia nigra across all seven datasets examined. This attenuation is selective for ALDH1A1-containing pairs, and this selectivity persists after adjusting for cell type enrichment changes. While correlational, these findings are consistent with a role for retinoic acid pathway disruption in PD pathophysiology and warrant mechanistic investigation.

PMID:42239820 | PMC:PMC13226206 | DOI:10.3389/fnagi.2026.1806505