Tag: statistics

Obes Surg. 2026 Jul 15. doi: 10.1007/s11695-026-08731-0. Online ahead of print.

ABSTRACT

BACKGROUND: The pharmacokinetics of oral psychotropic drugs can change after metabolic and bariatric surgery (MBS), affecting drug exposure. Given the risk of psychiatric decompensation, patients using psychotropic medications constitute a high-risk group requiring careful post-MBS monitoring. In particular, lithium, tricyclic antidepressants (TCAs), and clozapine are of concern because of their well-established dose-effect relationships, susceptibility to MBS-related exposure changes, and suitability for therapeutic drug monitoring (TDM). This study aimed to examine the prevalence of treatment interventions related to these medications in bariatric patients to prevent drug-related problems such as under- or overexposure requiring dosage adjustments or drug discontinuation.

METHODS: In this retrospective study, patient records from January 2017 to December 2023 were reviewed. Patients who underwent MBS and were using lithium, TCAs (amitriptyline, clomipramine, dosulepin, doxepin, imipramine, maprotiline, nortriptyline), and/or clozapine were included. Baseline characteristics, treatment interventions, and available drug plasma concentrations were collected preoperatively and up to one year postoperatively.

RESULTS: A total of 163 patients were included. Psychotropic drug adjustments were observed in 27 patients (16.6%) within the first year following MBS. Both pre- and postoperative drug plasma concentrations were available for three patients (1.8%). Three patients experienced worsening of psychiatric symptoms that necessitated hospitalization or intensive monitoring. No statistically significant differences in intervention rates were observed among patients with psychiatric disorders or pain.

CONCLUSION: Although only a minority of patients required psychotropic drug treatment interventions, monitoring psychotropic drug treatment is essential for safe and effective treatment post-MBS. Greater attention is needed regarding altered drug exposure, and plasma concentration monitoring may help optimize psychotropic pharmacotherapy in these patients.

PMID:42455492 | DOI:10.1007/s11695-026-08731-0

CNS Drugs. 2026 Jul 15. doi: 10.1007/s40263-026-01314-8. Online ahead of print.

ABSTRACT

BACKGROUND AND OBJECTIVES: Lumateperone, a simultaneous modulator of serotonin, dopamine, and glutamate neurotransmission, demonstrated efficacy and safety as adjunctive therapy in two phase III, randomized, double-blind, placebo-controlled trials in patients with major depressive disorder with inadequate antidepressant therapy (ADT) response. The objective of this pooled analysis of Studies 501 and 502 was to investigate the safety and tolerability of lumateperone 42 mg + ADT.

METHODS: Data were pooled from two studies that enrolled adults (aged 18-65 years) with Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition-defined major depressive disorder with inadequate response to one to two ADTs in the current depressive episode (Montgomery-Åsberg Depression Rating Scale Total score ≥ 24; Clinical Global Impression-Severity score ≥ 4). Patients were randomized to 6 weeks of oral lumateperone 42 mg + ADT or placebo + ADT. Safety measures included adverse events, body morphology, cardiometabolic parameters, prolactin levels, extrapyramidal symptoms (EPS), and suicidality.

RESULTS: The pooled population comprised 964 patients (lumateperone + ADT, n = 483; placebo + ADT, n = 481). Treatment-emergent adverse events (TEAEs) occurred in 68.1% and 45.1% of the lumateperone + ADT and placebo + ADT groups, respectively. Treatment discontinuation because of an adverse event occurred in 8.7% of the lumateperone + ADT group and 0.8% of the placebo + ADT group. The most common TEAEs (≥ 5%, greater than twice placebo + ADT) were dizziness, dry mouth, somnolence, nausea, fatigue, and diarrhea. Of patients experiencing TEAEs, the majority (96.3%) had events of mild or moderate severity. Potentially clinically significant weight increase (≥ 7%) occurred in 0.4% and 1.3% of the lumateperone + ADT and placebo + ADT groups, respectively. Changes in cardiometabolic parameters and prolactin levels were minimal and similar to placebo + ADT. No notable changes occurred in EPS-related scales. EPS-related TEAEs occurred in 5.8% and 1.7% of lumateperone + ADT and placebo + ADT groups, respectively. The most common EPS-related TEAE was tremor (lumateperone + ADT, 3.9%; placebo + ADT, 0.2%), which had a mean duration of 11.9 days in the lumateperone + ADT group. Emergence of suicidal ideation was infrequent (lumateperone + ADT, 1.6%; placebo + ADT, 2.5%).

CONCLUSIONS: Lumateperone 42 mg + ADT had a good safety profile and was generally well tolerated in this pooled analysis, with low risks of weight gain, cardiometabolic abnormalities, and EPS with short-term treatment but with higher discontinuation rates because of adverse events (8.7%) versus placebo + ADT, in patients with major depressive disorder with inadequate ADT response.

CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov: NCT04985942 (registered 22 July, 2021); NCT05061706 (registered 20 September, 2021).

PMID:42455478 | DOI:10.1007/s40263-026-01314-8

Matern Child Health J. 2026 Jul 15. doi: 10.1007/s10995-026-04306-8. Online ahead of print.

ABSTRACT

OBJECTIVES: To determine the extent to which acknowledged fathers’ education attainment is associated with the infant mortality rate of term births to African-American and non-Hispanic White women. We hypothesized that African American (compared to non-Hispanic White) term births would have a greater percentage of first-year deaths attributable to low paternal education attainment.

METHODS: Stratified and multivariable regression analyses were performed on the 2018-2019 National Center for Health Statistics US cohort-linked live birth-infant death data files. Only term (37-42 weeks) singleton births to non-Hispanic White (n = 2,937,995) and African-American (n = 508,374) U.S.-born women with acknowledged fathers and a non-missing value for paternal education were included.

RESULTS: Paternal low education attainment was higher among births to African-American women compared to non-Hispanic White women. In both races, infant mortality rates decreased with higher levels of paternal education attainment. When controlling for traditional maternal risk factors, the relative risk of infant mortality for births to fathers with < 12 years of education compared to a bachelor’s degree or higher equaled 1.59 (1.18-2.14) and 1.55 (1.35-1.77) for African-American and non-Hispanic White births, respectively. A greater percentage of term infant mortality was attributable to low paternal education attainment (< 12 years) in births to African-American (compared to non-Hispanic White) women (6.5% vs. 5.4%).

CONCLUSIONS: Acknowledged fathers’ education attainment is a determinant of term infant first-year mortality.

PMID:42455459 | DOI:10.1007/s10995-026-04306-8

Trop Anim Health Prod. 2026 Jul 15;58(6):419. doi: 10.1007/s11250-026-05191-7.

ABSTRACT

Toxoplasma gondii, an important food-borne parasite, has been reported in a wide range of food animals, including poultry. Dongan chicken, a native breed of Hunan province, subtropical China, is widely consumed, but its T. gondii infection status remains unknown. A total of 1,220 serum samples were collected from Dongan chickens intended for human consumption in Hunan province, China. Serum samples were tested for T. gondii IgG antibodies using an indirect hemagglutination assay (IHA). IgG antibodies against T. gondii were detected in 434 (35.6%; 95% CI: 32.9-38.3) of the examined serum samples. The seroprevalence of the six surveyed herds ranged from 31.7% to 39.8% (P > 0.05). Statistical analysis identified age, gender and farm model as significant risk factors for infection (P < 0.001). This is the first report of T. gondii seroprevalence in Dongan chickens in Yongzhou in Hunan province. The high seroprevalence suggests a potential risk for human and animal infection. Effective measures should be implemented to control T. gondii infection in Dongan chickens in Hunan province, subtropical China.

PMID:42455455 | DOI:10.1007/s11250-026-05191-7

Discov Oncol. 2026 Jul 15;17(1):1027. doi: 10.1007/s12672-026-05570-4.

ABSTRACT

INTRODUCTION: In gastrointestinal oncology, serum tumor markers such as CEA and CA19-9 are typically monitored over several weeks to assess therapeutic efficacy. The immediate impact of cytotoxic therapy on these serum tumor markers, however, remains poorly characterized.

METHODS: We analyzed a single-center cohort of patients with advanced gastrointestinal cancers (pancreatic, biliary, colorectal, and esophageal) treated with 5-fluorouracil-based regimens. Paired serum samples were collected immediately before the start of chemotherapy (0 h) and at the removal of the 48-h 5-FU continuous pump (48 h). The primary endpoint was the percentage change of tumor markers during this time window (∆CEA and ∆CA19-9). Secondary endpoints included the association of these acute kinetics with subsequent radiographic response.

RESULTS: 78 cycles of 5-FU-based chemotherapy were included (33 patients, median cycles per patient: 2). CA19-9 increased significantly after chemotherapy (median ∆CA19-9 + 4.8% per patient, Wilcoxon p = 0.015; mixed model p = 0.062; cycle-level range – 11% to + 92%), as did LDH (median ∆LDH + 12.8% per patient, both Wilcoxon and mixed model p < 0.001; cycle-level range – 39% to + 72%). CEA levels remained stable (median ∆CEA – 3.6% per patient, Wilcoxon p = 0.09; mixed model p = 0.05; cycle-level range – 20% to + 22%). There was no statistically significant association between early changes in serum tumor markers and radiographic outcome.

DISCUSSION: In this hypothesis-generating study, 5-FU-based therapy leads to a statistically significant increase in CA19-9 and LDH levels, but not in CEA, after 48 h. The magnitude of the increase did not predict radiographic response.

PMID:42455430 | DOI:10.1007/s12672-026-05570-4

Palliat Support Care. 2026 Jul 15;24:e196. doi: 10.1017/S1478951526103058.

ABSTRACT

OBJECTIVES: To (1) identify clinical situations that may contribute to the experience of moral distress (MD) among professionals working with motor neuron disease (MND), (2) measure the occurrence and intensity of MD, and (3) explore associations with professional quality of life, turnover intention, and associated risk and/or protective factors.

METHODS: A cross-sectional online survey was distributed to healthcare professionals working in MND services across Europe. Data were analyzed using descriptive and inferential statistics.

RESULTS: In total, 230 responses from professionals across 17 European countries were analyzed from the international survey. And 67% of respondents indicated that MD resonated with their experience of working with MND. Those who considered leaving or changing their position due to the challenges associated with caring for this patient population were also more likely to report resonance with MD (χ² = 7.772, p = 0.020). The intensity of MD was associated with reduced professional quality of life (burnout [β = 0.106, p < 0.05], and secondary traumatic stress [β = 2.881, p < 0.001]). A total of 24 clinical scenarios were identified as potential contributors to experiences of MD in this population. Across all professional groups, service-/organization-level factors were the most common and distressing barriers to providing effective MND care.

SIGNIFICANCE OF RESULTS: This study demonstrates that MD is experienced by healthcare professionals working with MND across Europe. MD was associated with reduced professional quality of life and increased intentions to leave or change positions, underscoring its potential implications for workforce retention and sustainability. The findings show that system/organization, patient/condition and family-level causes are the primary drivers of MD in this population. Future research should focus on evaluating the effectiveness of interventions designed to address these key drivers and mitigate the impact of MD among healthcare professionals working with MND.

PMID:42454435 | DOI:10.1017/S1478951526103058

Biosci Rep. 2026 Jul 15:BSR20260093. doi: 10.1042/BSR20260093. Online ahead of print.

ABSTRACT

Blastocyst culture is an essential part of IVF/ICSI treatments, however, it has been shown to increase the risk of preterm deliveries as well as large for gestational age infants. The effect of the extended culture on offspring phenotype is thought to be mediated by epigenetic mechanisms, since this developmental period coincides with extensive epigenetic remodelling. Here, we compare genome-wide DNA methylation of cord blood and umbilical cord artery samples collected from newborns resulting from cleavage-stage transfer (n = 25), blastocyst-stage transfer (n = 25) and spontaneous conception (n=30). Epigenome-wide association studies, global methylation analyses and epigenetic age comparison did not reveal statistically significant differences between the cleavage-stage and blastocyst-stage groups. However, we identified some loci with a > 10% difference in median methylation level between the groups, which should be studied further with a larger sample size. The genome-wide DNA methylation of spontaneously conceived and cleavage-stage newborns were comparable while in the spontaneous to blastocyst-stage comparison, cg25263722 was differentially methylated (p = 5×10-8) in umbilical cord artery. Our study did not identify major effects of extended culture on DNA methylation, which is reassuring with respect to the future health of newborns conceived via assisted reproductive technologies.

PMID:42454427 | DOI:10.1042/BSR20260093

Br J Math Stat Psychol. 2026 Jul 15. doi: 10.1111/bmsp.70062. Online ahead of print.

ABSTRACT

Standardized mean differences (SMDs) are widely used to quantify treatment effects in cluster-randomized trials. However, covariate adjustment in hierarchical linear models reduces the residual variance components used for standardization, which artificially inflates effect size estimates and undermines comparability across studies. We propose a unified family of estimators that recover the unadjusted variance components by rescaling the covariate-adjusted variance components using pseudo- $R^2$ indices. This rescaling places effect size estimates on a common reference scale, thereby improving comparability across studies and model specifications under standard modeling assumptions. The framework accommodates three covariate adjustment scenarios including level-1, level-2, and simultaneous both-level adjustments. Furthermore, it introduces three estimator types spanning method of moments, maximum likelihood, and a t-statistic reformulation suitable for meta-analysis from published summaries, alongside delta-method variance approximations for each. An empirical example and a simulation study apply the proposed covariate-adjusted SMDs across these scenarios to illustrate their implementation and demonstrate the consequences of omitting the correction.

PMID:42454368 | DOI:10.1111/bmsp.70062

Adv Med Educ Pract. 2026 Jul 10;17:618836. doi: 10.2147/AMEP.S618836. eCollection 2026.

ABSTRACT

INTRODUCTION: Simulation enables safe, structured practice of laparoscopic skills outside the operating room, yet objective, threshold-referenced performance data from mandatory postgraduate curricula in Central and Eastern Europe remain scarce. We report the educational outcomes of a structured, multi-level virtual-reality (VR) laparoscopy curriculum delivered at a single national simulation center.

METHODS: We conducted a single-center prospective observational study of 29 obstetrics and gynecology residents who completed a four-module laparoscopic course (Basic 1-2, Advanced 1-2) at the Centre for Endoscopy Simulation, Centre of Postgraduate Medical Education (CMKP), Warsaw. Outcomes comprised pre- and post-course single-choice knowledge tests, self-assessed competence, satisfaction, and simulator-based performance evaluated against a priori, criterion-referenced passing thresholds. Technical metrics were simulator-generated (Simbionix LAP Mentor); no human global rating scales were used. Demographic and training-related variables (gender, residency year, training-center referral level, prior endoscopic experience) were analyzed with non-parametric statistics.

RESULTS: Knowledge scores improved from 20.9 (SD = 2.70) to 29.2 (SD = 1.01) (Wilcoxon, p <0.05). Self-assessed competence increased significantly across all domains (p <0.05). Satisfaction was uniformly high (mean 4.7/5, SD = 0.45) but did not correlate with objective performance (all p >0.05). Outcomes did not differ by gender or training-center referral level; residency year was associated with performance only in colpotomy (ρ = -0.37, p =0.047), and prior experience predicted performance mainly in basic camera manipulation (e.g. 30° navigation distance, ρ = -0.50, p =0.005), consistent with a learning-curve effect.

CONCLUSION: A structured, multi-modular VR laparoscopy course significantly improved theoretical knowledge and self-assessed competence among OB-GYN residents. Within this single-center cohort, measured outcomes did not differ by gender or training-center referral level. High satisfaction diverged from objective performance, underscoring the need for balanced, criterion-referenced evaluation. A priori passing thresholds enabled transparent, proficiency-oriented assessment.

PMID:42454356 | PMC:PMC13367472 | DOI:10.2147/AMEP.S618836

Int J Gen Med. 2026 Jul 10;19:620783. doi: 10.2147/IJGM.S620783. eCollection 2026.

ABSTRACT

BACKGROUND: Elevated red cell distribution width (RDW) has been implicated in chronic mountain sickness; however, its relationship with acute mountain sickness (AMS) remains uncertain. We aimed to evaluate the association between elevated RDW and AMS among Chinese young men undergoing high-altitude air ascent.

METHODS: 157 participants (median age, 22 years) were enrolled and passively ascended primarily by air from 500 m to 3,650 m, spending approximately 3.5 hours. Participants were classified as AMS+ and AMS- based on their Lake Louise AMS score (LLS) after 24 hours at 3,650 m. Measurements included heart rate (HR), blood pressure, pulse oximeter saturation (SpO₂), and complete blood count (CBC). Statistical analyses included correlation analysis, logistic regression, and receiver operating characteristic (ROC) curve analysis.

RESULTS: The prevalence of AMS at 3,650 m was 45%. AMS+ participants had higher HR and RDW and lower SpO₂ than AMS- participants. LLS was positively correlated with age, BMI, HR, and RDW, and negatively correlated with SpO₂. Adjusted logistic regression revealed independent risk factors for AMS, including lower SpO₂ (odds ratio [OR] = 0.809, P < 0.01), higher RDW coefficient of variation (RDW-CV) (OR = 2.790, P < 0.01), and a higher neutrophil-to-monocyte ratio (OR = 1.114, P < 0.05). ROC curve analysis demonstrated that elevated RDW-CV is a significant diagnostic indicator for AMS, with an optimal cutoff of 13.7, yielding a sensitivity of 94.37%, specificity of 45.35%, and an area under the curve (AUC) of 0.703.

CONCLUSION: The findings suggest that elevated RDW-CV is linked to an increased risk of AMS among Chinese young men primarily undergoing air ascent to 3,650 m.

PMID:42454354 | PMC:PMC13367465 | DOI:10.2147/IJGM.S620783