Tag: statistics

CPT Pharmacometrics Syst Pharmacol. 2025 Aug 1. doi: 10.1002/psp4.70090. Online ahead of print.

ABSTRACT

Phase 2 trials have historically focused on characterizing the dose-exposure-response relationship in relatively homogeneous patient populations before proceeding to confirmatory trials. However, with the rise of multi-regional Phase 2 trials, it is important to strike a balance between this goal and the requirement to make sure that the optimal doses are chosen for patients from various geographic areas. This study uses a dose-ranging trial for an anti-psoriatic drug, featuring a typical design with a total sample size of N = 175, to highlight key considerations regarding sample size in multi-regional exploratory studies. The allocation of sample size to a region of interest (Region X) was evaluated using both a conventional statistical approach and a pharmacometric model-based (PMx) approach, predicated on the assumption of a minimum treatment improvement in Region X. Further evaluation was performed to assess the probability of reaching reliable conclusions regarding clinically relevant inter-regional differences in treatment response. The statistical approach, relying solely on end-of-trial observations from a single dose group, exhibited a maximum power of less than 40% in detecting treatment differences across regions when Region X accounts for 50% of the total sample size. In contrast, the PMx approach, employing data from multiple dose groups across trial duration, demonstrated that 26% of the total sample size yielded over 80% power to identify the inter-regional difference. The PMx approach has also been shown to offer a more efficient characterization of the clinical relevance of inter-regional differences, and has potential to improve decision-making in development progression by integrating prior knowledge.

PMID:40751361 | DOI:10.1002/psp4.70090

J Diabetes. 2025 Aug;17(8):e70132. doi: 10.1111/1753-0407.70132.

ABSTRACT

OBJECTIVES: Whether diverse metabolic statuses within a similar body mass index (BMI) category associate with different in vitro fertilization (IVF) outcomes.

DESIGN: A retrospective cohort study.

SETTING: Wenzhou, Zhengjiang Province, China.

POPULATION: This retrospective cohort study prescreened 16 458 women who underwent their first IVF and fresh embryo transfer cycle between January 2010 and December 2021.

METHODS: Metabolic status was assessed using the National Cholesterol Education Program-Adult Treatment Panel III criteria. Patients were then categorized into six groups: metabolically healthy normal weight, metabolically unhealthy normal weight, metabolically healthy overweight, metabolically unhealthy overweight, metabolically healthy obese, and metabolically unhealthy obese.

MAIN OUTCOME MEASURES: The primary outcome was live birth rate.

RESULTS: Regarding live birth, rates in normal weight women were initially lower for metabolically unhealthy normal weight versus metabolically healthy normal weight (44.6% vs. 48.6%), but this was not significant after multivariate adjustment. In obese women, live birth rates were similar between metabolically unhealthy obese and metabolically healthy obese (41.5% vs. 43.9%), with no adjusted difference. For secondary outcomes, metabolically unhealthy normal weight patients had lower biochemical pregnancy rates than metabolically healthy normal weight (OR: 0.86, 95% CI: 0.76-0.98); high blood pressure was a significant risk factor for this outcome in metabolically unhealthy normal weight (OR: 0.84, 95% CI: 0.72-0.98).

CONCLUSION: Our findings indicated that different cardio-metabolic risk factors but a similar BMI category may have limited adverse effects on live birth rate.

PMID:40751359 | DOI:10.1111/1753-0407.70132

Int J Paediatr Dent. 2025 Aug 1. doi: 10.1111/ipd.70024. Online ahead of print.

ABSTRACT

BACKGROUND: The relationship between primary teeth and their successors involves complex interactions that may influence the development of permanent teeth.

AIM: To evaluate alterations in permanent premolars after endodontic treatment of their primary molar predecessors.

DESIGN: A prospective study was conducted with children initially aged 5 to 9 years, who were submitted to pulpectomy of a primary molar. The protocol involved instrumentation of root canals and obturation with a zinc oxide-eugenol paste. Follow-up examinations were performed until exfoliation of the primary molars and full eruption of the successor premolar. Permanent premolars were assessed for developmental defects of enamel, ectopic eruption, and crown rotation. Logistic regression was used to explore variables associated with these outcomes.

RESULTS: Forty-seven children were followed up for approximately 6 years. Among the successor permanent premolars, 21.3% presented crown rotation, 10.6% ectopic eruption, 6.4% enamel hypomineralization, and 2.1% enamel hypoplasia. No statistically significant association was observed between the assessed alterations and demographic or treatment-related variables, including pulp status, interradicular lesion, root resorption, or root overfilling (p > 0.05).

CONCLUSION: Eruptive alterations were the most frequent findings. No association was identified between variables related to the endodontic treatment of primary molars and subsequent clinical alterations in permanent premolars.

PMID:40751355 | DOI:10.1111/ipd.70024

J Res Adolesc. 2025 Sep;35(3):e70057. doi: 10.1111/jora.70057.

ABSTRACT

In this study, we explore the influence of culture on adolescent identity formation, using the recently postulated master narrative framework. Most identity research using the framework thus far has departed from specific, a priori defined master narratives and domains. However, considering the rapidly changing and globalized sociocultural landscape, it is vital to consider contemporary developments and investigate what master narratives guide and constrain today’s adolescents’ identities. We therefore take a qualitative, bottom-up approach, examining adolescents’ narratives without a priori defining what master narratives to focus on. Our study consisted of a reflexive thematic analysis of 15 focus groups interviews reaching a total of 72 Flemish adolescents. We developed three master narratives, each consisting of two contradicting imperatives. “I should be myself, but also fit in,” “I can be anything I want, but must be realistic,” and “I need to be happy now, but also work to be happy later.” The study underscores the importance of understanding adolescent identity formation as the dynamic navigation of multiple, contradicting sociocultural discourses. Furthermore, the analysis highlights the way current adolescent identity is embedded within the all-encompassing social organization of neoliberal capitalism.

PMID:40751353 | DOI:10.1111/jora.70057

Colorectal Dis. 2025 Aug;27(8):e70192. doi: 10.1111/codi.70192.

ABSTRACT

BACKGROUND: Extremes of body weight may be associated with poorer outcomes after colorectal surgery (CRS). We aimed to compare perioperative results and healthcare costs across the full range of body mass index (BMI) categories in an Asian cohort following CRS.

MATERIALS AND METHODS: This retrospective study was conducted using the American College of Surgeons – National Surgical Quality Improvement Programme (ACS-NSQIP) Participant Use Data File to identify patients ≥18 years old who underwent major elective CRS between January 2018 and December 2023. Both malignant and benign surgical indications were included. Emergency surgery was excluded. BMI was classified according to WHO Asian categories.

RESULTS: Over 72 months, 3169 patients (53.3% male), with a median age of 68.4 years, underwent elective CRS (83.4% for colorectal cancer). The median overall BMI was 23.2 (IQR 20.5-26.3) kg/m² with 351 (11.1%) underweight, 1168 (36.8%) normal weight, 566 (17.9%) overweight, 819 (25.8%) obesity class I and 265 (8.4%) obesity class II. Underweight BMI was independently associated with increased 30-day mortality (OR 2.54, 95% CI 1.01-6.41) and pneumonia (OR 1.89, 95% CI 1.03-3.40), while overweight BMI was independently associated with increased deep incisional surgical site infection (OR 3.31, 95% CI 1.18-9.97). The underweight group incurred the highest mean total cost per patient at $28,557.35, which was $4624.17 higher compared to the overall mean (p = 0.001).

CONCLUSION: Underweight BMI is independently associated with increased risks of early mortality and pneumonia following CRS in an Asian population, with greater healthcare costs incurred compared to patients in higher BMI categories.

PMID:40751348 | DOI:10.1111/codi.70192

HGG Adv. 2025 Jul 31:100487. doi: 10.1016/j.xhgg.2025.100487. Online ahead of print.

ABSTRACT

We developed an imputation panel for Alzheimer’s disease (AD) and related dementias (ADRD) using 15,958 whole-genome sequencing (WGS) samples from the Alzheimer’s Disease Sequencing Project (ADSP). Recognizing the importance of associations between structural variants (SVs) and AD, and their underrepresentation in existing public reference panels, our panel uniquely integrates single nucleotide variants (SNVs), short insertions and deletions (indels), and SVs. This panel enhances the imputation of rare variants underlying disease susceptibility onto genotype array data, offering a cost-effective alternative to whole-genome sequencing while significantly augmenting statistical power. Notably, we discovered 10 rare indels nominal significant related to AD that are absent in the TOPMed-r2 panel and identified one genome-wide significant (P < 5 x 10^-08) and three suggestive significant (P < 1 × 10^-05) AD-associated SVs. These findings provide the other insights into AD genetics and underscore the critical role of imputation panels in advancing our understanding of complex diseases like ADRD.

PMID:40751311 | DOI:10.1016/j.xhgg.2025.100487

J Clin Anesth. 2025 Jul 31;106:111946. doi: 10.1016/j.jclinane.2025.111946. Online ahead of print.

ABSTRACT

BACKGROUND: Annual professional practice evaluations (i.e., peer review) are mandatory for anesthesiologists in many practice settings. The de Oliveira Filho clinical anesthesia supervision instrument is a valid and psychometrically reliable tool suitable for these high-stakes assessments. We studied item-specific feedback to anesthesiologists to increase their scores.

METHODS: The retrospective cohort study used all 11 academic years for which the studied department used the supervision instrument, July 2013 through June 2024. There were 55,195 evaluations of 715 combinations of anesthesiologist and year by 242 rating trainees (e.g., anesthesia residents), each evaluation with 9-items scored 4=always, 3=frequently, 2=rarely, or 1=never.

RESULTS: The 9-item supervision instrument had Cronbach alpha 0.96 and functioned as a binary (4 vs ≤3) multivariate array. Consequently, the 87% (47,859/55,195) of evaluations with all 9 items 4=always, or all 9 items ≤3, provided information about the quality of performance of the anesthesiologists, but no potentially useful item-specific information for feedback to anesthesiologists. Cochran Q tests were performed for each of the 715 combinations of anesthesiologist and year using the remaining 7336 evaluations. There were 17% (124/715) of the combinations of anesthesiologist and year with adjusted P < 0.05, showing one or more of the items’ scores differed significantly from the other items’ scores. The 17% of combinations represented 6.0% (3311/55,195) of evaluations. For each of those 124 combinations of anesthesiologist and year, 36 McNemar tests were performed, comparing the 1st item to the 2nd, …, 8th item to 9th. Among those pairwise comparisons that were statistically significant, the directions of odds ratios were examined. The items about teaching quality accounted for 19% and 26% of the odds ratios <1 (i.e., low scores), respectively, while the other seven items each accounted for ≤5%.

CONCLUSIONS: Earlier it was known that anesthesiologists’ annual professional practice evaluations can be provided along with education regarding good teaching attributes associated with high quality intraoperative supervision and greater supervision scores. Our results show that also providing analyses of individual item scores could benefit, at most, <20% of the faculty anesthesiologists.

PMID:40749386 | DOI:10.1016/j.jclinane.2025.111946

Pediatr Neurol. 2025 Jul 9;171:21-27. doi: 10.1016/j.pediatrneurol.2025.07.003. Online ahead of print.

ABSTRACT

BACKGROUND: Tuberous sclerosis complex (TSC) is a genetic disorder that can cause multiorgan hamartomas. The brain is often affected by cortical tubers, subependymal nodules, and subependymal giant cell astrocytoma (SEGA). Consensus guidelines recommend frequent brain magnetic resonance imaging (MRI), in the pediatric population, to monitor for SEGA. This study compares the effectiveness of fast-sequence nonsedated limited MRI with standard MRI.

METHODS: Fifty-one patients with TSC had both MRIs. Two attending pediatric neuroradiologists measured subependymal lesions, lateral ventricle diameter, and changes in measurements compared with the most recent prior MRI.

RESULTS: Sixty-five percent of patients required sedation for standard MRI. The mean age was 8.7 years. There was no significant difference between radiologists in identifying SEGA or measuring lateral ventricle size, regardless of imaging type. However, Radiologist A measured subependymal lesions smaller than Radiologist B. There was a statistically significant difference in lesion measurement on the anteroposterior (AP) view, with an average 0.6 mm smaller (P = 0.028) on limited MRI compared with standard MRI. There was no significant difference in the transverse view measurement (P = 0.77) or lateral ventricle size (P = 0.57). Additionally, there was no significant difference in the percent change of subependymal lesions over time between the two imaging types (transverse view P = 0.95, AP view P = 0.52).

CONCLUSIONS: Limited MRI reduces health care costs, repetitive sedation, and MRI scanner time, overall requiring less hospital resources. Limited MRI is clinically similar in accuracy to standard MRI. Limited MRI should be incorporated in the assessment of SEGA in pediatric TSC.

PMID:40749383 | DOI:10.1016/j.pediatrneurol.2025.07.003

Eur J Radiol. 2025 Jul 28;191:112342. doi: 10.1016/j.ejrad.2025.112342. Online ahead of print.

ABSTRACT

PURPOSE: Computed tomography angiography (CTA) is a widely used diagnostic tool, but concerns about radiation exposure necessitate accurate dose estimation. This study investigates the correlation between Effective Dose (ED) and Size-Specific Dose Estimate (SSDE) estimated from the patient’s body mass index (BMI) in CTA to evaluate the utility of SSDE-BMI as a patient-specific dosimetry parameter.

METHODS: A retrospective analysis of 422 adult patients (226 males and 196 females) with an average age of 51.28 years undergoing Coronary Computed Tomography Angiography (CCTA) was conducted. Two values of ED were derived (ED103 and ED_DLP derived using the dose-length product (DLP) and ICRP conversion factors), while the two values of SSDE_BMI were calculated from the volume-computed tomography dose index (CTDIvol) and the patient’s BMI.

RESULTS: Overall, statistical analysis revealed a strong positive correlation between ED103 and SSDE_BMIs, significantly stronger than correlations between traditional metrics ED_DLP and SSDE_BMI. A highly significant correlation between these two dose indices was observed across various patients’ BMI and gender. The highest correlation was reported for Obese Class II female patients, which is attributed to proportional dose adjustments made to compensate for increased X-ray attenuation.

CONCLUSIONS: These findings underscore SSDEs’ importance in personalized radiation risk assessment and protocol optimization. This supports the use of SSDE_BMI as a reliable, patient-specific dose metric in radiation protection strategies for CCTA.

PMID:40749323 | DOI:10.1016/j.ejrad.2025.112342

Res Vet Sci. 2025 Jul 25;194:105814. doi: 10.1016/j.rvsc.2025.105814. Online ahead of print.

ABSTRACT

Equine endometritis is the primary reproductive pathology that causes significant economic losses due to subfertility, and Staphylococcus aureus (S. aureus) is one of the main infectious agents. Oxygen-ozone is a gas with high oxidative potential that promotes the destruction of bacterial cells, modulates inflammation, and induces a regenerative response, making it an adequate alternative treatment for endometritis. This study aimed to evaluate the antimicrobial and antibiofilm effects of the oxygen-ozone gas on microbial cultures of S. aureus. Closed ozonated systems were used in three experiments. The S. aureus cultures were then treated with the oxygen-ozone mixture by either bubbling the gas through the Tryptic Soy Broth with the bacteria or directly exposing the plates to the gas while testing different amounts and lengths of the exposure. In the first experiment, it was observed that the bactericidal effect on the planktonic state increased after 10 min, and showed a better result at 60 min. In experiment two a bactericidal effect with exposure for 10 min to concentrations of 19 and 41 μg/mL was observed. After exposure for 20 min, a concentration of 10 μg/mL was effective in killing the strain in the planktonic state. Antibiofilm effects were observed at concentrations of 19, 41, and 70 μg/mL. Therefore, it can be concluded that S. aureus showed sensitivity to oxygen-ozone gas, which also promoted an antibiofilm effect on the studied strain.

PMID:40749316 | DOI:10.1016/j.rvsc.2025.105814