Tag: statistics

J Patient Rep Outcomes. 2026 Feb 13. doi: 10.1186/s41687-026-01018-z. Online ahead of print.

ABSTRACT

BACKGROUND: The QUAlity of Life Assessment in Spina bifida (QUALAS) is a self-administered questionnaire that measures health-related quality of life. The Japanese versions of QUALAS for children and teenagers with spina bifida (SB) have been validated. This study aimed to develop and validate the reliability and validity of the Japanese version of QUALAS-A (QUALAS-A-J), the adult version of the instrument.

METHODOLOGY: The participants were adults with SB aged ≥ 18 years. The results of cognitive interviews and a preliminary survey conducted on 16 participants were analyzed to confirm the face and content validity of the responses, and the item wording was modified. The revised questionnaire was administered from April to December 2022. The survey requested responses regarding demographics, QUALAS-A-J, and the World Health Organization Quality of Life Scale (WHOQOL-26). We then calculated descriptive statistics and correlation coefficients, and conducted exploratory factor analysis and Student’s t-test. Cronbach’s α and retests were used to determine reliability and intraclass correlation coefficients (ICCs), respectively.

RESULTS: Valid responses were received from 133 participants (52% female; mean age, 31.3 ± 10.5 years). Factor analysis indicated a 12-item, three-factor structure. Three items related to sexual activity that had low variance estimates were eliminated. Two factors converged on the same items as the original version; the correlation coefficients for QUALAS-A-J and WHOQOL-26 domains were 0.36 ≤ r ≤ 0.72, which confirmed discriminability for two domains. In all three domains, health-related quality of life was higher for those without than for those with urinary incontinence, validating known-groups validity. Cronbach’s α was 0.66-0.88 and the ICCs were > 0.8, thereby confirming reliability.

CONCLUSIONS: The present study evaluated the reliability of QUALAS-A-J, which has three domains, 12 items, and two original and one new structure.

PMID:41686393 | DOI:10.1186/s41687-026-01018-z

Ann Biomed Eng. 2026 Feb 13. doi: 10.1007/s10439-026-04011-1. Online ahead of print.

ABSTRACT

BACKGROUND: For decades, researchers have used Detrended Fluctuation Analysis (DFA) as a method to assess the temporal structure of gait variability through the Hurst exponent (H). However, DFA’s reliance on long time series limits reliability and reduces statistical power when applied to short walking trials, restricting its applicability. The Hurst-Kolmogorov process (HKp), an increasingly common algorithm, may offer more reliable and efficient estimates of the H in short walking trials. This study evaluated the reliability and statistical power of HKp versus DFA in estimating H from gait kinematics using short time series.

METHODS: 119 healthy adults (34 young, 57 middle-aged, and 38 older) were sampled from the NONAN GaitPrint dataset. Each participant walked 9 four-minute trials per day over the course of two days, which were a week apart. H was estimated for stride interval, stride length, and the lower limb joint range of motion using DFA and HKp. Kinematic variables were calculated for time series ranging from 50 to 175 strides. Intraclass correlation coefficients (ICCs) were calculated between days using the average of 1 to 9 trials per day. Power estimations using simulated time series were performed to assess the ability of each method to detect group differences under varying effect sizes, sample sizes, trial numbers, and time series lengths.

RESULTS: HKp achieved excellent reliability (ICC > 0.90) in short trials (<100 strides), whereas DFA rarely exceeded moderate reliability. Statistical power simulations demonstrated that HKp yielded higher power than DFA, particularly when fewer trials and subjects were available. A summary table is provided to guide sample size selection under different design conditions.

CONCLUSION: HKp offers a more reliable and statistically powerful alternative to DFA for estimating H in short walking trials. These findings support HKp as a practical tool for assessing the temporal structure of gait variability, improving feasibility in experimental and research settings.

PMID:41686388 | DOI:10.1007/s10439-026-04011-1

J Neurooncol. 2026 Feb 13;176(3):210. doi: 10.1007/s11060-025-05366-6.

ABSTRACT

PURPOSE: Brain tumors, characterized by the uncontrolled proliferation of abnormal cells within cerebral tissue, remain clinically challenging entities. Radiotherapy and chemotherapy constitute fundamental therapeutic modalities; however, their effects on healthy brain structures are not fully understood. This study aimed to evaluate the impact of these treatments on volumetric changes in brain structures and tumor size in patients with primary or metastatic brain tumors.

METHODS: A retrospective cohort of 47 patients aged 18-90 years treated at Inonu University Turgut Özal Medical Center between 2012 and 2023 was analyzed. Brain MRI scans were evaluated at three time points: pre-treatment, post-radiotherapy, and post-chemotherapy. Radiotherapy was delivered at a median dose of 60 Gy in 30-33 fractions, and temozolomide was used as the chemotherapy agent. Volumetric measurements of the telencephalon, diencephalon, ventricles, white matter, brainstem, cerebellum, and cerebral cortex were performed using MRICloud, while tumor volumes were quantified using the VolBrain platform. All volumetric differences were statistically tested using repeated-measures ANOVA with corresponding p-values reported.

RESULTS: A statistically significant increase in telencephalon volume was observed after radiotherapy, followed by a return toward baseline measurements after chemotherapy. The diencephalon demonstrated a significant and persistent volume reduction following radiotherapy (p < 0.05). No statistically significant volumetric changes were identified in the ventricles, white matter, brainstem, cerebellum, or cerebral cortex (p > 0.05). Tumor volume changes were also statistically evaluated and showed no significant differences across the three time points (p = 0.456), indicating stable disease during the treatment course.

CONCLUSION: Radiotherapy and chemotherapy lead to region-specific volumetric alterations in the brain. The transient telencephalon enlargement is more likely attributable to treatment-related edema or inflammatory processes rather than functional improvement. The persistent diencephalon volume decline may reflect early treatment-related tissue vulnerability. Incorporating automated volumetric assessment into routine follow-up may support early detection of therapy-related structural changes and facilitate more personalized treatment planning.

PMID:41686371 | DOI:10.1007/s11060-025-05366-6

Drug Saf. 2026 Feb 13. doi: 10.1007/s40264-026-01652-y. Online ahead of print.

ABSTRACT

BACKGROUND AND AIMS: Herpes zoster (HZ) infection and long-term non-steroidal anti-inflammatory drugs (NSAIDs) use are established risk factors for stroke and other cardiovascular diseases. Given the paucity of evidence regarding an association between NSAIDs use and HZ on stroke risk, this case-crossover study, utilizing a nationwide, population-based cohort, aimed to investigate the effect of HZ infection and concurrent NSAIDs use on the incidence of stroke.

METHODS: Using Taiwan’s National Health Insurance database (2014-2020), we identified 336,075 patients with incident stroke. A case-crossover design comparing exposure to HZ and NSAIDs between the focal period (1-30 days before stroke) and referent period (366-395 days before stroke) was employed. Conditional logistic regression estimated adjusted odds ratios (aORs) for stroke risk associated with NSAIDs use during HZ episodes. Pre-planned subgroup analyses further examined such effects on stroke subtypes (ischemic stroke, hemorrhagic stroke, and transient ischemic attack [TIA]), across age groups (< 50, 50-64, ≥ 65 years) and in patients with various comorbidities, including immunocompromised and autoimmune diseases, cardiometabolic risk factors, and renal and liver diseases.

RESULTS: Combined HZ infection and NSAIDs use was associated with doubled stroke risk (aOR 2.05, 95% confidence interval [CI] 1.80-2.33) compared with periods without either exposure. For specific stroke types, the aORs were 1.94 (95% CI 1.65-2.29) for ischemic stroke, 1.81 (95% CI 1.34-2.43) for hemorrhagic stroke, and 2.81 (95% CI 2.06-3.85) for TIA. HZ episodes without NSAIDs (aOR 1.70, 95% CI 1.45-2.00) and NSAIDs use alone (aOR 1.42, 95% CI 1.40-1.44) showed lower but significant risk increment. In age-stratified analyses, individuals aged 65 years and older exhibited a significantly elevated stroke risk while concurrently utilizing NSAIDs during HZ episodes (aOR 2.19, 95% CI 1.92-2.62). Subgroup analyses demonstrated consistent elevated risks in patients with pre-existing comorbidities, particularly immunocompromised conditions (aOR 3.07, 95% CI 1.95-4.81) and renal disease (aOR 4.30, 95% CI 2.20-8.41).

CONCLUSIONS: Our findings demonstrate a significant association between HZ infection and NSAIDs use on stroke risk, particularly among individuals aged 65 years and older or those with pre-existing immunocompromised, cardiometabolic, and chronic conditions. The optimization of pain management strategies during HZ episodes is paramount to mitigate the risk of stroke while ensuring effective management of HZ-associated pain.

PMID:41686364 | DOI:10.1007/s40264-026-01652-y

Arch Osteoporos. 2026 Feb 13;21(1):34. doi: 10.1007/s11657-026-01663-3.

ABSTRACT

In our real-world study of women with postmenopausal osteoporosis (PMO), general practitioners (GPs) adhered to French guidelines on stopping, changing, or continuing oral bisphosphonates in 60% of cases and adhered to guidelines on initiating oral BPs in only 39%. These findings highlight the need to educate GPs on PMO treatment recommendations.

PURPOSE: French guidelines for postmenopausal osteoporosis (PMO) recommend dual energy X-ray absorptiometry (DXA) assessment of bone mineral density (BMD) to guide treatment decisions. However, data reporting implementation of these guidelines in general practice is lacking. Our study assessed general practitioners’ (GPs’) use of DXA results to guide decisions regarding first-line oral bisphosphonate (oBP) treatment in women with PMO.

METHODS: In this multicenter cohort study, participating GPs enrolled women with PMO who had been receiving the first-line bisphosphonates for 2-5 years, had a reference (baseline) DXA in the 2 years pre-enrolment or ≤ 2 years prior to BP initiation, and agreed to a follow-up DXA. GPs prescribed a follow-up DXA to guide their decision to stop, continue, or change BPs. We checked the GPs’ decision for concordance with national treatment guidelines.

RESULTS: From January 2018 to November 2019, 23 GPs enrolled 99 women meeting the inclusion criteria. Based on follow-up DXA, the decision to stop, change, or continue oBPs aligned with guidelines in 60% of cases. Agreement was higher in women receiving oBPs for < 3 vs ≥ 3 years (70.2% vs 54.3%). Based on baseline DXA, the decision to initiate treatment was aligned in only 39% of cases, with the follow-up treatment decision aligned with guidelines in 72% of these cases. The consistency of treatment decision between GPs and the scientific committee was weak (kappa coefficient of 0.295).

CONCLUSION: Our study suggests insufficient awareness of national recommendations for PMO treatment in French general practice, highlighting the need for stronger GP education.

PMID:41686362 | DOI:10.1007/s11657-026-01663-3

Dermatol Ther (Heidelb). 2026 Feb 13. doi: 10.1007/s13555-026-01668-3. Online ahead of print.

ABSTRACT

INTRODUCTION: Topical corticosteroids are regarded as the first-line therapy for chronic hand eczema (CHE), despite a lack of substantial evidence from randomized controlled trials to confirm their efficacy. Topical benvitimod is a potential alternative for long-term maintenance.

METHODS: A prospective, single-center, open-label randomized trial was conducted, using a parallel-group design and enrolling 64 patients who had moderate-to-severe CHE. Patients were randomly divided into two treatment groups: 32 patients used 1% benvitimod cream twice a day for 8 weeks, whereas the other 32 patients received halometasone cream on the same application schedule and duration. The percentage of patients who achieved “treatment success” at week 12 was the primary endpoint. Secondary endpoints included changes in physician-assessed Hand Eczema Severity Index (HECSI), patient-reported subjective scores, the relapse rate, and adverse events. Patient-reported subjective scores included Patient Global Assessment (PaGA), Dermatology Life Quality Index (DLQI), and Quality of Life in Hand Eczema Questionnaire (QOLHEQ).

RESULTS: Fifty-nine patients completed the trial (30 in the benvitimod group and 29 in the halometasone group). The treatment success rate was 26.7% (8/30) in the benvitimod group and 24.1% (7/29) in the halometasone group (p = 0.824) at week 12. From baseline to week 12, the two groups demonstrated significant reductions in HECSI, PaGA, DLQI, and QOLHEQ scores (p < 0.05). However, no statistically significant differences were observed between the two groups. Among patients who achieved treatment success, 25.0% (2/8) patients in the benvitimod group and 57.1% (4/7) patients in the halometasone group relapsed at week 24 (p = 0.315). The main adverse events associated with benvitimod were skin pigmentation, pruritus, and skin dryness, none of which led to treatment discontinuation.

CONCLUSIONS: Benvitimod exhibits efficacy comparable to halometasone in managing moderate-to-severe CHE, along with a favorable safety and a low relapse rate.

TRIAL REGISTRATION NUMBER: ChiCTR2100051948.

PMID:41686361 | DOI:10.1007/s13555-026-01668-3

Int Ophthalmol. 2026 Feb 13;46(1):111. doi: 10.1007/s10792-026-03952-9.

ABSTRACT

PURPOSE: To compare safety, efficacy and patient experience when treated with intravitreal injections of a 30-gauge needle compared to a 34-gauge needle.

METHODS: A Prospective Randomized controlled study in a single tertiary medical center. Patients were randomly assigned to receive prescheduled intravitreal injection with either a 30 or a 34-gauge needle. Intravitreal injections were performed by a senior vitreoretinal surgeon or by a resident. After the intravitreal injection was performed, patients were asked to grade pain sensation on a Visual Analog Scale (VAS score). In addition, the presence or absence of subconjunctival hemorrhage (SCH) was recorded, as well as any post-injection complications in the following month.

RESULTS: Our cohort included 91 patients with a total of 114 injections. Mean age was 72.8 ± 12, with 51 females and 40 males. The mean pain score in the 30-gauge group was 3.17 ± 2.11 vs 3.05 ± 2.45 in the 34-gauge group. There was no statistically significant difference in the mean pain score among the two groups (p = 0.571) nor in gender (p = 0.563) overall. However, when the injections performed by a senior vitreoretinal surgeon, 34-gauge needles were statistically significantly less painful than 30-gauge needles (2.5 ± 2.0 vs. 3.4 ± 1.8; p = 0.04). Additionally, no difference was recorded in formation of SCH among the groups (p = 1).

CONCLUSION: The use of a 34-gauge needle was found to be less painful when used by a senior vitreoretinal surgeon and with similar safety profile as the 30 gauge needle. This may further improve patient satisfaction and increase treatment adherence.

PMID:41686360 | DOI:10.1007/s10792-026-03952-9

Clin Drug Investig. 2026 Feb 13. doi: 10.1007/s40261-026-01529-z. Online ahead of print.

ABSTRACT

BACKGROUND AND OBJECTIVES: The intricate nature of pediatric patients’ physiology and the frequent administration of multiple medications in pediatric intensive care units expose hospitalized patients to potential drug-drug interactions. Therefore, this study aimed to examine and characterize clinically relevant drug-drug interactions in pediatric patients admitted to intensive care units, leveraging artificial intelligence to enhance their identification and management.

METHODS: Prescription data from pediatric intensive care unit admissions were analyzed using ContraIndicator, a natural language processing-based framework developed for the identification of potential drug-drug interactions. Medication information extracted from prescription records was evaluated against the DDInter database, and its clinical relevance was determined using the severity ratings of the database (major, moderate, and minor). Using univariate and multivariate logistic regression, the associations between severity and age, as well as between severity and the number of prescribed medications, were investigated.

RESULTS: The examination of 8010 prescriptions for 899 hospitalized patients identified 3884 potential drug-drug interactions. The most frequent interacting drug pairs were midazolam + fluconazole, fluconazole + fentanyl, fentanyl + dexamethasone, and vancomycin + piperacillin. Among the 49.6% (446) of pediatric patients who had at least one interaction (major, moderate, or minor), 38.8% (173) had a major potential drug-drug interaction. In this investigation, a higher number of prescribed drugs was significantly linked with a higher incidence of potential drug-drug interactions (odds ratio: 12.79; 95% confidence interval: 8.26-20.6; p < 0.001).

CONCLUSIONS: The study suggests that potential drug-drug interactions are frequent in pediatric intensive care units. The majority of these interactions were moderate, followed by major severity. There is a statistically significant association between the quantity of drugs provided and the prevalence of potential drug-drug interactions. The findings of this study could aid in planning and executing future studies, as well as in monitoring and preventing potential drug-drug interactions in patients receiving intensive care. This study introduces ContraIndicator, a graphical user interface that presents empirical findings and promotes awareness regarding potential drug-drug interactions.

PMID:41686358 | DOI:10.1007/s40261-026-01529-z

Support Care Cancer. 2026 Feb 13;34(3):195. doi: 10.1007/s00520-026-10458-8.

ABSTRACT

BACKGROUND & AIMS: Post-treatment anxiety and depression are prevalent but often underrecognized among bladder cancer patients. This systematic review and meta-analysis aimed to estimate the pooled prevalence of these symptoms and to evaluate the effectiveness of intensive nursing interventions.

METHODS: A comprehensive search of PubMed, EMBASE, the Cochrane Library, and Web of Science was conducted through October 18, 2025. Eligible studies included those reporting the prevalence or severity of anxiety and/or depression in bladder cancer patients, as well as studies comparing intensive nursing interventions with routine care. Data were synthesized using Stata/MP version 14.0. Standardized mean differences (SMDs) with 95% confidence intervals (CIs) were calculated. Heterogeneity was assessed using the I² statistic, and subgroup analyses were performed to explore potential sources of variability.

RESULTS: Sixteen studies involving 1,791 patients were included. The pooled prevalence of anxiety was 25.3% (95% CI: 22.2-28.6%) and that of depression was 29.4% (95% CI: 23.3-35.9%). Higher prevalence rates were observed in non-Western populations and among patients receiving multimodal treatment. Compared with routine care, intensive nursing interventions were associated with significant reductions in anxiety (SMD = -4.52; 95% CI: -6.07 to -2.96) and depression (SMD = -4.51; 95% CI: -5.96 to -3.07) (both P < 0.001). These findings remained robust in sensitivity analyses despite substantial heterogeneity.

CONCLUSION: Anxiety and depression are common among bladder cancer survivors. Intensive nursing interventions are associated with meaningful improvements in psychological outcomes and may be considered for integration into post-treatment supportive care.

TRIAL REGISTRATION: PROSPERO registration number: CRD42024590858.

PMID:41686342 | DOI:10.1007/s00520-026-10458-8

Discov Oncol. 2026 Feb 13. doi: 10.1007/s12672-026-04641-w. Online ahead of print.

ABSTRACT

Alterations in the vaginal microbiota contribute to the pathogenesis of cervical neoplasia. However, the distinctions in microbiota changes related to different human papillomavirus (HPV) subtypes, as well as the variation in gut microbiota, have not been fully explored. In this research, we endeavored to explore the shifts in the vaginal and intestinal microbiota in correlation with the advancement of cervical neoplasia and HPV infection. A total of 578 vaginal and intestinal cross-sectional specimens were collected from 348 subjects and subjected to 16 S rRNA sequencing. Statistical analyses were performed using R language, and Student’s t-test was employed to assess the significance of differences. Both within and between, sample diversity of the vaginal and intestinal microbiota exhibited substantial alterations across cervical intraepithelial neoplasia (CIN) stages and cervical carcinoma. The vaginal genera Lactobacillus, Enterococcus, Peptoniphilus, Atobium, Anerococcus, and Veillonella were associated with different CIN stages and cervical cancer type, whereas Allisonella, Lachnospiracae, Lactobacillus, Staphylococcus, and Sellimonas were associated with varying HPV types. A Random Forest-driven classifier highlighted the predictive potential of differential bacteria in cervical neoplasia and HPV infection, with intestinal bacteria showing higher predictive accuracy in certain instances. Specifically, the accuracy of differentiating CIN I from CIN III was superior for the intestinal bacterial model compared to the vaginal bacterial model (85.52% vs. 83.33%). The model also demonstrated high accuracy in predicting HPV infection, particularly in distinguishing HPV-16 from HPV-18 and HPV-58, with AUC values of 81.61% and 83.07%, respectively, compared to less than 70% for vaginal bacteria. Our findings reveal the intricate interplay among cervical neoplasia, HPV infection, and microbiota, with potential diagnostic and therapeutic implications.

PMID:41686340 | DOI:10.1007/s12672-026-04641-w