Tag: statistics

Invest New Drugs. 2026 Jun 19. doi: 10.1007/s10637-026-01628-w. Online ahead of print.

ABSTRACT

Cemiplimab is a fully human PD-1 inhibitor approved for cutaneous squamous cell carcinoma, basal cell carcinoma, and non-small cell lung cancer. Post-market safety surveillance is essential given the broad and evolving indications for immune checkpoint inhibitors. All FAERS reports with cemiplimab as the primary suspect drug were extracted. Proportional Reporting Ratios (PRR), Reporting Odds Ratios (ROR), and chi-squared statistics were calculated for each adverse event. Disproportionality signals were defined by PRR ≥ 2, chi-squared ≥ 3.841, and a minimum of 15 reports. A total of 1,460 cemiplimab reports were identified in the FAERS database. Twenty-two adverse events met all signal detection criteria. The strongest signals were observed for myocarditis (PRR 54.35, n = 40), myositis (PRR 46.10, n = 25), pemphigoid (PRR 36.06, n = 16), and pneumonitis (PRR 19.37, n = 31). Immune-mediated adverse events predominated, consistent with the mechanism of PD-1 blockade. FAERS disproportionality analysis identifies a signal profile for cemiplimab dominated by immune-related adverse events across cardiac, pulmonary, dermatologic, and endocrine systems. These findings are consistent with the known immunotoxicity of PD-1 inhibitors and support heightened clinical vigilance for myocarditis and immune-mediated pneumonitis.

PMID:42319596 | DOI:10.1007/s10637-026-01628-w

Environ Monit Assess. 2026 Jun 19;198(7):749. doi: 10.1007/s10661-026-15598-2.

ABSTRACT

Roadside dust samples were analyzed for potentially toxic metals (PTMs) using atomic absorption spectrometry (AAS). Ecological and health risks of PTMs were assessed using the pollution index (PI), nemerov integrated pollution index (NIPI), ecological risk index (ERI), enrichment factor (EF), average daily dose (ADD), hazard quotient and hazard index (HQ and HI), and carcinogenic risk (CR). The mean concentrations (mg kg⁻¹) of PTMs in samples existed as Cr (1.55-61.95), Cd (1.2-6.25), Pb (0.5-58), and Ni (2-46.7) across all study sites. Compared with control soils, roadside dust exhibited overall elevated PTM concentrations. PI values exceeded 1 for all PTMs, indicating a high level of pollution, while Cd showed high enrichment (EF > 5) and considerable ecological risk (ERI < 150) in the majority of samples. Non-carcinogenic and carcinogenic health risks were with in safe limits (< 1) for all samples. Ingestion was the dominant exposure pathway, followed by inhalation and dermal contact. Children exhibited higher health risks as compared to adults due to lower body weight and higher exposure. Principal component analysis (PCA) suggested that PTMs primarily originated from anthropogenic sources, and Pearson’s correlation analysis showed that most variables were significantly correlated (p ≤ 0.5). The outcomes of the study would be valuable in finding effective measures for the mitigating stratagies of PTMs in environment.

PMID:42319592 | DOI:10.1007/s10661-026-15598-2

J Robot Surg. 2026 Jun 19;20(1):611. doi: 10.1007/s11701-026-03583-3.

ABSTRACT

Patients with cirrhosis have increased rates of gallstone formation. While laparoscopic cholecystectomy (LC) is known to be safe in cirrhosis, perioperative morbidity remains higher than the general population. Prior work has suggested that robotic cholecystectomy (RC) may improve outcomes for patients with cirrhosis. This was a retrospective propensity score-matched (PSM) analysis of patients with cirrhosis undergoing cholecystectomy within an academic health system between January 2015 and December 2025. The primary outcome was rate of Clavien-Dindo grade IIIa or higher complication. Demographics and clinical characteristics/outcomes were compared using standard statistical techniques. The total cohort included 139 patients: 108 (77.6%) LC and 31 (22.3%) RC. Prior to PSM, RC patients had significantly higher MELD scores (11 vs. 10, P = 0.024), greater prevalence of ascites at surgery (35.5% vs. 14.8%, P = 0.018), and more elective case status (96.8% vs. 72.2%, P = 0.003). After PSM, 61 LC and 31 RC patients remained for analysis, without significant difference in MELD score or elective status (all P > 0.05). In the PSM cohort, there was not a significant difference in major morbidity rate by approach (4.8% vs. 6.5%, P > 0.9), while estimated blood loss (10 vs. 25 mL, P < 0.001) and open conversion rate (0 vs. 12.9%, P = 0.049) were significantly lower for RC. RC was associated with equivalent perioperative outcomes to LC in patients with cirrhosis in this study. Larger studies are warranted to define the optimal approach to cholecystectomy in this population.

PMID:42319583 | DOI:10.1007/s11701-026-03583-3

J Robot Surg. 2026 Jun 19;20(1):604. doi: 10.1007/s11701-026-03572-6.

ABSTRACT

Robot-assisted peritoneal flap vaginoplasty has emerged as an evolving reconstructive option in gender-affirming genital surgery. This systematic review and single-arm meta-analysis aimed to synthesize the available evidence regarding its perioperative, functional canal, and postoperative safety outcomes. This study was conducted according to PRISMA guidelines and prospectively registered in PROSPERO. PubMed, Cochrane Library, Embase, and Web of Science were searched from database inception to May 2026. Eligible studies included transfeminine or gender-diverse individuals undergoing robot-assisted peritoneal flap-based vaginoplasty with extractable clinical outcomes. Continuous outcomes were synthesized as weighted mean estimates with 95% confidence intervals (CIs), and overall postoperative complications were pooled using Stata version 18.0. Heterogeneity was assessed using the I² statistic, and leave-one-out sensitivity analyses were performed. Ten studies involving 974 patients were included. The pooled mean operative time was 305.37 min (95% CI 244.62, 366.12), and the pooled length of hospital stay was 5.80 days (95% CI 4.72, 6.87). At the last available follow-up, pooled neovaginal depth was 13.41 cm (95% CI 12.86, 13.96), and pooled neovaginal width was 3.61 cm (95% CI 3.55, 3.67). The pooled overall postoperative complication rate was approximately 30.1%. Sensitivity analyses suggested that the pooled estimates were not driven by any single study. Robot-assisted peritoneal flap vaginoplasty appears feasible and may achieve neovaginal dimensions broadly comparable to those reported for other full-depth vaginoplasty approaches. However, predominantly retrospective single-arm evidence precludes conclusions regarding superiority and highlights the need for standardized prospective studies with longer follow-up and patient-reported outcomes.

PMID:42319579 | DOI:10.1007/s11701-026-03572-6

Exp Physiol. 2026 Jun 19. doi: 10.1113/EP092753. Online ahead of print.

ABSTRACT

Traditionally, studies in experimental physiology have been conducted in small groups of human participants, animal models or cell lines. Identifying optimal study designs that achieve sufficient power for drawing proper statistical inferences to detect group level effects with small sample sizes has been challenging. Moreover, average effects derived from traditional group-level inference do not necessarily apply to individual participants. Here, we introduce N-of-1 trials as an innovative study design that can be used to draw valid statistical inference about the effects of interventions on individual participants and can be aggregated across multiple study participants to provide population-level inferences more efficiently than standard group randomized trials. N-of-1 trials have been used in healthcare settings since the late 1980s, but without large-scale adoption and with few applications in experimental physiology research settings. In this paper, we introduce the key components and design features of N-of-1 trials, describe statistical analysis and interpretations of the results, and describe some available digital tools to facilitate their use using examples from experimental physiology.

PMID:42318774 | DOI:10.1113/EP092753

Soft Matter. 2026 Jun 19. doi: 10.1039/d6sm00448b. Online ahead of print.

ABSTRACT

Chiral active Brownian particles (CABPs) are self-propelled agents with intrinsic rotational dynamics, giving rise to circular trajectories commonly observed in biological and synthetic microswimmers. Understanding how CABPs explore confined environments and locate targets is crucial for characterizing transport, search efficiency, and reaction processes in physical and biological systems. We study the escape dynamics of CABPs from one- and two-dimensional confined domains. In one dimension, we consider intervals with either two absorbing boundaries or a reflecting boundary on one side and an absorbing boundary on the other, and derive closed-form asymptotic solutions in the high-chirality regime, revealing the quantitative scaling of the mean first passage time (MFPT) as a function of particle rotation speed (chirality). In two dimensions, we analyze escape from a disk containing one absorbing arc or two symmetric absorbing arcs. By numerically solving the governing partial differential equations, we compute the MFPT for CABPs to escape the domains as a function of the particle’s initial orientation, self-propulsion speed, angular velocity, and domain geometry. Our results show that, depending on the parameters and geometry, the MFPT can exhibit non-monotonic behavior as a function of chirality. A minimal escape time exists at an intermediate value of chirality, where the rotational time scale balances the active swimming time scale, redirecting a particle towards the exit which would otherwise be blocked due to unfavorable initial orientation. Our work offers a comprehensive characterization of CABP escape dynamics in canonical confinements and identifies chirality as a key control parameter for transport and search in confined physical and biological systems.

PMID:42318759 | DOI:10.1039/d6sm00448b

Kathmandu Univ Med J (KUMJ). 2025 Oct-Dec;23(92):534-539.

ABSTRACT

Background Breastfeeding self-efficacy predicts breastfeeding success. Studies shows that although mothers recognize its importance, many lack adequate knowledge of proper breastfeeding practices. Objective To assess breastfeeding self-efficacy and postnatal depressive symptoms and compare the breast-feeding efficacy score differences with selected variables and postnatal depressive symptoms among postnatal mothers. Method A cross- sectional study was conducted from 1st-28th August 2022 among 109 postnatal mothers in postnatal ward of Dhulikhel Hospital. The postnatal mothers were selected by convenience sampling method. Data collection was done by using structured questionnaire through interview method. Descriptive statistics (frequency, percentage, median and interquartile range) and inferential statistics (Mann Whitney U test and Kruskal Wallis test) were used. Result There was total 109 postnatal mothers. The median breastfeeding self-efficacy score was 55 with interquartile range 59 and 51. Nearly one fourth (21.1%) of postnatal mothers had presence of depressive symptoms. The mean overall Edinburgh Postnatal Depression Scale score was 9.37 (SD = 2.89; ranging from 1 to 18). The study showed higher breastfeeding score among age above 30 years, who received prenatal health information about breastfeeding, having previous experience of breastfeeding and who decided to breastfeed before childbirth. Conclusion The study showed that more than half of postnatal mothers had high median score of breastfeeding self-efficacy and nearly one fourth of postnatal mothers had presence of depressive symptoms. There was statistically significant difference between mothers’ age, received prenatal health information about breastfeeding, previous experience of breastfeeding and time of decision to breastfeed with breastfeeding self- efficacy score.

PMID:42318734

Kathmandu Univ Med J (KUMJ). 2025 Oct-Dec;23(92):529-533.

ABSTRACT

Background Subarachnoid block (SAB) is a widely practiced regional anesthetic for lower limb surgeries. The patient position for subarachnoid block induction, either sitting or lateral decubitus, may affect hemodynamic stability and block quality. Objective To compare the incidence of hypotension and the onset times of block in these two positions. Method In this prospective single-center observational comparative study, 108 patients, who were scheduled to undergo elective lower limb surgery, were equally assigned to subarachnoid block in sitting position (SP) and Lateral decubitus position (LP) groups. An intrathecal dose of hyperbaric Bupivacaine 0.5% (15 mg) was given. Hemodynamic variables, onset of sensory and motor block, maximum level of sensory and motor block and any complications including hypotension and bradycardia were recorded and compared. Categorical variables were analyzed using the Chi-square test, and continuous variables were compared using the unpaired Student’s t-test. Result The incidence of hypotension was greater in sitting position group (20.41%) than in LP group (16.67%), but the difference was not statistically significant. Out of these, bradycardia was more frequent in sitting position (9.2%) as compared to lateral decubitus position (7.4%). The onset times of sensory and motor blocks in the lateral decubitus position group were significantly shorter (p < 0.05). Conclusion Lateral decubitus position results in superior early hemodynamic stability and shorter time to sensory and motor block onset as compared to sitting in subarachnoid block for elective lower limb surgeries.

PMID:42318733

Kathmandu Univ Med J (KUMJ). 2025 Oct-Dec;23(92):523-528.

ABSTRACT

Background Ageing is a key demographic trend with universal implications, particularly in South Asia. In Nepal, the elderly people face socio-economic challenges such as poverty anddeclining family support. The old age allowance introduced in 1995 and gradually increased over time. Objective To assesses the relationship between old age allowance and fulfillment of fundamental needs among elderly people in Chandragiri Municipality. Method The analytical cross-sectional study was carried out in Chandragiri Municipality from 1st December 2023 to 30th May 2024. Simple random sampling technique was adopted. Participants were asked for socio-demographic information, socioeconomic information, and old age allowances by using a structured interview schedule. Data analysis included descriptive as well as inferential statistics. Thechisquare test wascarried outto assess relationship between old age allowances and fulfillment of fundamental needs. Result Out of 422 elderly individuals, 56.9% lacked an old age allowance, mostly due to age ineligibility (43.4%). Major demographics included 55.7% female, 69.2% Hindu, and 41.2% Janajati. While 54.5% reported adequate income, significant relationship was found between receiving an allowance and the fulfillment of fundamental needs (p = 0.001). Conclusion The study found that nearly half of the participants received old age allowances. It showed that there was relationship between old age allowances and fulfillment of fundamental needs. It is recommended that policymakers and local governments enhance the accessibility and inclusivity of the old age allowance program. Strengthening income sufficiency through supplementary programs or increasing the allowance amount could significantly alleviate financial inadequacies.

PMID:42318732

Kathmandu Univ Med J (KUMJ). 2025 Oct-Dec;23(92):512-517.

ABSTRACT

Background The refractive error is an anomaly of the dioptric system of the eye in which rays of light are not focused on the retina. Objective To ascertain the pattern and prevalence of refractive error and visual impairment secondary to it in the pediatric population attending to ophthalmology department of Dhulikhel hospital. Method This was a hospital-based, prospective, cross-sectional study design. Presenting visual acuity, age of presentation, refractive status, best corrected visual acuity, and status of visual impairment were assessed in children ranging from 3-15 years presenting to the Ophthalmology department of Dhulikhel Hospital within the period of 6 months. They underwent assessment of visual acuity in different charts (as per their co-operation level) and cyclorefraction. History of use of spectacle was noted, and the children were categorized into different visual impairment categories as per their presenting visual acuity. Paired t-test was used to assess the improvement in visual acuity, post-refractive error correction. Result Out of 1,498 children examined during the study period, 116 (7.74%) had refractive error. Among these 60 (51.70%) were females and 56 (48.30%) were males. The mean age at presentation was 11.45±3.62 years. Astigmatism was the most common subtype seen in 45.26% (N=105 eyes), followed by Myopia (42.67%, N=99 eyes) and Hypermetropia (11.21%, N=26 eyes). Only 36.20% (N=42) of the pediatric population were using spectacle. 62.90% (N= 73 children) had some of visual impairment during their presentation. There was statistically significant improvement in visual acuity after refractive correction (paired t-test, P < 0.001). Conclusion Refractive errors were common among children with astigmatism having highest prevalence and majority presenting with visual impairment. Lack of awareness, infrequent ocular examination and lack of vision screening were the main causes for the late presentation. So, early detection through screening programs and timely management is recommended to enhance quality of life.

PMID:42318730