Category: Statistics

Dig Dis Sci. 2025 May 3. doi: 10.1007/s10620-025-09074-z. Online ahead of print.

ABSTRACT

The rising number of gastrointestinal (GI) tumors, including esophageal, gastric, and colorectal tumors, makes it essential to develop more effective treatment methods. Endoscopic submucosal dissection (ESD) has become a popular intervention due to its ability to resect the tumor completely and prevent local recurrence. This study evaluates the safety and efficacy of ESD with rubber bands and clips (ESD-RBC) in the treatment of various GI tumors. We systematically searched Embase, Scopus, Web of Science, Medline/PubMed, and Cochrane databases until April 20, 2024. Eligible studies included clinical trials and observational studies focusing on ESD-RBC alone or compared to conventional ESD (C-ESD) in patients with gastrointestinal tumors. The risk of bias was assessed using the Newcastle-Ottawa Scale (NOS) tool. Statistical analyses were performed using RevMan and R software. ESD-RBC was superior to C-ESD in achieving R0 resection and en bloc resection (OR: 1.99 with 95% CI [1.17 to 3.36], P = 0.01, I² = 0%) and (OR: 5.98 with 95% CI [2.30 to 15.55]; P = 0.0002, I² = 0%), respectively. ESD-RBC enhanced the resection speed compared to C-ESD (MD: 8.48 mm²/min with 95% CI [3.12 to 13.83]; P < 0.00001, I² = 89%) and shortened the procedure duration (MD: – 11.94 min with 95% CI [- 21.98 to – 1.91]; P < 0.00001, I² = 7%). There was no statistically significant difference between both groups in terms of bleeding and delayed bleeding (OR: 1.08 with 95% CI [0.37 to 3.14]; P = 0.89, I² = 0%) and (OR: 0.69 with 95% CI [0.20 to 2.33]; P = 0.55, I² = 0%), respectively. The proportion of R0 resection using ESD-RBC was 90%, with 95% CI [65% to 98%] and I² = 78%. The en bloc resection rate was 96%, with 95% CI [95% to 97%], and I² = 0%. In addition, the raw mean (MRAW) of resection speed was 24.25 mm2/min, with 95% CI [13.48 to 35.02], and I² = 99.4%. ESD-RBC was superior to C-ESD in achieving en bloc resection and R0 resection with a comparable risk of bleeding and delayed bleeding. In addition, ESD-RBC enhanced the resection speed and shortened the procedure duration.

PMID:40319201 | DOI:10.1007/s10620-025-09074-z

Cardiooncology. 2025 May 2;11(1):42. doi: 10.1186/s40959-025-00339-0.

ABSTRACT

BACKGROUND: Dexrazoxane, a putative iron chelator, is effective in preventing doxorubicin-induced cardiotoxicity. However, dexrazoxane is also a catalytic inhibitor of topoisomerase 2b (Top2b), a key mediator of doxorubicin toxicity. Preclinical studies have shown that dexrazoxane induces Top2b degradation, and early administration (8 h before doxorubicin) can prevent doxorubicin-induced cardiotoxicity. In this study, we investigated the dose-response relationship and time course of dexrazoxane-induced Top2b degradation in human volunteers.

METHODS: Twenty-five healthy female volunteers received an intravenous infusion of dexrazoxane at doses ranging from 100 mg/m² to 500 mg/m². Blood samples were collected hourly from time zero to 12 h, as well as at 24- and 48-h post-infusion. Peripheral blood mononuclear cells (PBMCs) were isolated, nuclear fractions were extracted, and Top2b expression was analyzed by western blot using Lamin B1 as a control. A linear mixed-effects model was used to assess differences among the five dose groups.

RESULTS: Dexrazoxane infusion led to a rapid and sustained reduction of Top2b in PBMCs, lasting up to 12 h. Statistical analysis revealed a significant difference in Top2b levels among the five dose groups (p = 0.0002). Subgroup analysis identified a significant difference between the 100 mg/m² and 500 mg/m² groups (p = 0.005). However, topoisomerase 2a (Top2a), the molecular target of doxorubicin’s tumor-killing effect, remained unchanged following dexrazoxane infusion.

CONCLUSIONS: Findings from this dose-response and time-course study can inform the design of future clinical trials investigating the efficacy of early dexrazoxane administration in preventing doxorubicin-induced cardiotoxicity while minimizing the risk of tumor protection.

TRIAL REGISTRATION: (Funded by the National Institute of Health, RO1HL151993; PHOENIX trials, ClinicalTrials.gov number, NCT03930680.).

PMID:40317097 | DOI:10.1186/s40959-025-00339-0

BMC Vet Res. 2025 May 2;21(1):312. doi: 10.1186/s12917-025-04772-2.

ABSTRACT

BACKGROUND: Foot-and-mouth disease (FMD) is a highly contagious viral infection that infects cloven-hoofed animals, including cattle, sheep, goats, swine, and various wildlife species. Ethiopia is found in pool four where Serotype A, Serotype O, SAT1 and SAT2 are endemic. A retrospective study was conducted to analyse the spatial and temporal patterns of FMD outbreaks in export-sourcing areas of Southeastern Ethiopia over 12 years (from January 2011 to December 2022), using reported FMD outbreak data. Geographically, the area extending from Borana to East Shoa, along the main road connecting Moyale to Adama, was identified as the primary FMD outbreak zone within the cattle export-sourcing areas of southeastern Ethiopia.

RESULTS: The data on Foot-and-mouth disease (FMD) outbreaks over the past twelve years (from January 2011 to December 2022) obtained from the Ministry of Agriculture’s, Ethiopia database were retrieved and analyzed. There were a total of 58,426 cases across 247 outbreaks in 11 zones and 89 districts within the cattle export-sourcing areas of southeastern Ethiopia. On average, there were 20.3 outbreaks per year, with a median of 18 outbreaks annually, corresponding to approximately 4.6 outbreaks per month. The highest incidence occurred in January. The year with the most reported outbreaks was 2011, which had 54 outbreaks, followed by 2020 with 39 outbreaks and 2015 with 30 outbreaks In contrast, there were very few outbreaks recorded in 2014 and 2019. The case fatality rate was 1.02%, and an estimated 4,775,124 cattle were at risk of FMD infection. A time-series decomposition of the FMD outbreak data revealed seasonal trends. The trend analysis indicated that FMD outbreaks occurred in a cycle of two to five years, with peaks observed in 2011, 2012, 2015, and 2021. The incidence of FMD outbreaks varied across different zones, being lowest in the Afder and Gedeo zones and highest in the Arsi zone. An analysis using a space-time permutation probability model within the SaTScan software, with a maximum cluster size of 50%, identified five high-risk clusters and four low-risk clusters that were statistically significant (P < 0.05).

CONCLUSIONS: These spatial and temporal cluster analyses highlighted regions and periods with significantly higher-than-expected FMD outbreaks. The spatiotemporal and cluster analysis of FMD outbreaks provides critical insights for prioritizing control, prevention, and prophylactic measures in cattle export-sourcing areas of southeastern Ethiopia.

PMID:40317069 | DOI:10.1186/s12917-025-04772-2

Inj Epidemiol. 2025 May 2;12(1):25. doi: 10.1186/s40621-025-00573-1.

ABSTRACT

BACKGROUND: Unintentional firearm death (UFD) rates are higher among Black children than among White and Hispanic children. Whether disparities in UFD rates among Black as compared to White and Hispanic children vary by other demographic characteristics or by circumstances is unknown.

METHODS: Data come from the 32 states contributing to the National Violent Death Reporting System (NVDRS), 2015-2021. Our sample comprises children 0-17 who died from unintentional firearm injuries. Race/ethnicity- and age-specific population data at the state and county level were used to calculate rates. UFD rates were compared within and across race-ethnicity groupings by age, sex, urbanization and across four NVDRS coded circumstances. Urbanization was assigned using a six-level urban-rural classification scheme from the National Center for Health Statistics (NCHS) based on the county in which the fatal injury occured.

FINDINGS: Of the 568 UFDs, four-fifths of victims were male (82%) and four-fifths died in a home (84%), usually the Victim’s home (55%). Most deaths involved a child playing with a firearm (63%). Overall, UFD rates were 4.6-fold higher for Black children compared with White children. Black children’s rates were more than 6-fold higher than those of White children for females and for children five to nine years of age, and nearly 8-fold higher for children living in large central metro counties.

CONCLUSIONS: Black children die from unintentional firearm injury at disproportionately high rates, especially young children living in urban centers. The underlying reasons for these racial disparities are unclear and should be a priority for future research.

PMID:40317060 | DOI:10.1186/s40621-025-00573-1

Alzheimers Res Ther. 2025 May 2;17(1):97. doi: 10.1186/s13195-025-01745-3.

ABSTRACT

BACKGROUND: Emerging evidence supports the diagnostic and prognostic utility of plasma biomarkers in Alzheimer’s disease (AD), particularly in early disease stages. We sought to extend these findings by evaluating the prognostic value of plasma biomarkers in a clinical trial of mild-to-moderate AD.

METHODS: Post-hoc analyses investigated whether baseline concentrations of plasma biomarkers (Aβ42/Aβ40, T-tau, P-tau181, NfL, and GFAP) predicted change in ADAS-Cog11, CDR-SB, and volumetric MRI among participants in T2 Protect AD, a negative 48-week, phase-2, placebo-controlled trial of troriluzole in mild-to-moderate AD. All trial participants met diagnostic criteria for probable AD. Baseline concentrations of, and 48-week changes in, plasma biomarkers were assessed for association with 48-week change in outcomes using linear regression. Combinations of baseline biomarkers that best predicted change on the ADAS-Cog11 and CDR-SB were identified using least absolute shrinkage and selection operator (LASSO) regression. Biomarker-informed sample size calculations were modeled.

RESULTS: Of 350 trial participants, 319 had all requisite biomarker and clinical outcome data for inclusion in these analyses (mean age 71.5, SD = 8.03; 58.6% female). Higher plasma NfL at baseline predicted worsening scores on the ADAS-Cog11 (effect size (ES) = 1.42, 95%CI = [0.43, 2.41], p = 0.026) and CDR-SB (ES = 0.42, 95%CI = [0.10, 0.73], p = 0.048). LASSO regression revealed that worsening on the ADAS-Cog11 was best predicted by the combination of baseline plasma NfL, T-tau, and Aβ42/40 ratio, whereas baseline NfL alone best predicted worsening on CDR-SB. Higher baseline NfL predicted increasing ventricular volume (ES = 1.30cm³, 95%CI = [0.43, 2.17], p = 0.018) and decreasing mid-temporal cortical volume (ES = -0.47, 95%CI = [-0.74, -0.20], p = 0.003). Increasing NfL over the 48-week trial was associated with worsening on CDR-SB but not ADAS-Cog11. Modeling of biomarker-informed power calculations revealed that including high NfL as a trial entry criterion could substantially reduce requisite trial sample size.

CONCLUSIONS: Elevated baseline plasma NfL predicted more rapid clinical decline and MRI volume loss. Furthermore, increasing plasma NfL concentration over time was associated with worsening on the CDR-SB. Plasma NfL is an easily accessible biomarker that may enhance the design of clinical trials in mild-to-moderate AD.

TRIAL REGISTRATION: The T2 Protect AD trial was registered as NCT03605667 on clinicaltrials.gov on 2018-07-27.

PMID:40317057 | DOI:10.1186/s13195-025-01745-3

J Neuroinflammation. 2025 May 2;22(1):130. doi: 10.1186/s12974-025-03447-x.

ABSTRACT

BACKGROUND: In both humans and rodents, inappropriate feeding times during pregnancy can cause maternal metabolic abnormalities, increasing the risk of neurodevelopmental disorders in both the mother and offspring. Using a rat model, this study investigates whether feeding only during the inactive phase in rats leads to anxiety-like behaviors and abnormal brain development in fetuses through gut microbiota imbalance.

METHODS: 10-week-old female rats in the inactive-phase feeding group (IF group) were first trained for daytime feeding, ensuring that energy intake was statistically insignificant and different from that of the normal diet feeding group (ND group). They were then paired with male rats, and the previous feeding regimen was continued after pregnancy. Anxiety-like behavior was evaluated using the open-field test. Maternal caecal microbiota was analyzed using 16S rRNA sequencing. Enzyme-linked immunosorbent assay (ELISA) measured serum inflammation factors. RT-PCR was employed to assess mRNA levels of integrity genes and inflammatory cytokines in the maternal hippocampi, intestines, fetal brains, and placentae.

RESULTS: There were no statistically significant differences in energy intake or body weight gain between the IF and ND groups. In the open field test, dams in the IF group exhibited anxiety-like behavior, as indicated by fewer entries into and shorter duration in the central zone. Active-phase fasting elevated maternal serum inflammatory cytokine levels and impaired antioxidant capacity. It also increased intestinal permeability and induced gut microbiota dysbiosis, characterized by a decrease in Akkermansia and an increase in Dubosiella. Changes in the expression of intestinal circadian genes and elevated intestinal inflammatory cytokines were observed. Lipopolysaccharide (LPS) translocated into the maternal circulation, activated Toll-like receptor 4 (TLR 4), and passed through the compromised placental barrier into the fetal brain, leading to increased expression of inflammatory cytokines in the fetal brain.

CONCLUSIONS: The misalignment between maternal feeding time and the biological clock during pregnancy disrupts the balance of the gut microbiota and peripheral rhythms. The impaired intestinal and placental barriers allow LPS from the gut to infiltrate the maternal hippocampus and fetal brain, increasing inflammation and impacting both maternal and fetal brain health.

PMID:40317047 | DOI:10.1186/s12974-025-03447-x

BMC Oral Health. 2025 May 2;25(1):680. doi: 10.1186/s12903-025-06053-8.

ABSTRACT

BACKGROUND: The COVID-19 pandemic significantly disrupted healthcare systems, particularly affecting vulnerable populations such as children and individuals with special needs, causing delays and reductions in routine dental services. The aim of this study was to evaluate level of access and identify determinants of access to oral healthcare for children aged 0-13 during COVID-19 restrictions.

METHODS: Mixed-methods research design was adopted. This cross-sectional study included 270 children aged 0 to 13 years who visited Ege University Pediatric Dental Clinics between August 2021 and February 2022. Interviewer-administered questionnaires collected information about sociodemographic and economic characteristics, as well as dental service utilization during the pandemic. “Access” to receive oral health care to address existing dental problems is defined separately for each application to the institution. Statistical analyses were conducted using IBM SPSS Statistics 23, with Pearson’s Chi-Square, Fisher’s Exact, and Binary Logistic Regression tests applied to examine variable relationships. A 95% confidence interval and a significance level of p < 0.05 were adopted, with model fit assessed using the Hosmer-Lemeshow test and Nagelkerke R². Qualitative data from 16 in-depth interviews were analysed using thematic analysis to explore the barriers to accessing oral healthcare during the COVID-19 pandemic.

RESULTS: During the pandemic, 62.3% of dental institutions’ applications had limited access to care. Parental education, employment status, and household income significantly affected access (p < 0.005). Multiple logistic regression revealed that applying to university clinics (OR = 4.78; 95% CI 2.24-10.21) and private institutions (OR = 4.33; 95% CI 2.30-8.17) led to higher access rates when compared to public dental centres. The father’s regular employment (OR = 3.39; 95% CI 1.37-8.34) and the child’s previous dental contacts (OR = 2.37; 95% CI 1.21-4.62) increased the likelihood of accessing oral healthcare. The risk of contracting infections and income loss were pandemic related barriers. The most common barriers were those concerning the availability of services at public dental clinics. Children with disabilities faced further barriers due to the risk of infection, difficulty reaching institutions, and unmet dental needs for treatment under general anaesthesia.

CONCLUSION: Higher socioeconomic status and past contact with dentists had a positive effect on oral healthcare access. Dental services provided by public institutions had a lower level of access. The COVID-19 pandemic highlighted oral healthcare inequalities, particularly for those children with disabilities in Türkiye. Policymakers should strengthen public health crisis plans in order to improve children’s oral healthcare access.

PMID:40317032 | DOI:10.1186/s12903-025-06053-8

Trials. 2025 May 3;26(1):146. doi: 10.1186/s13063-025-08848-0.

ABSTRACT

BACKGROUND: Adhesive capsulitis (AC) is a progressive inflammatory condition of the shoulder that causes functional limitations and leads to long-term disability. The study aimed to elicit the effectiveness of proprioceptive neuromuscular facilitation (PNF) compared to standard physiotherapy approaches on AC.

METHODS: An assessor-blinded single-centre randomised control trial (RCT) was carried out on 80 AC patients between May 2022 and December 2023 in Bangladesh. Random assigned and concealed allocated patients were recruited equally (n = 40) to each PNF and conventional capsular stretching group. The experimental group received a PNF approach, and the control group received capsular stretching to the affected shoulder for 24 sessions in 6 weeks. Both groups received electrical modalities as standard treatment. The primary outcome was pain measured by the numeric pain rating scale (NPRS) and range of motion in a universal goniometer. The secondary outcome was functional limitation measured by the shoulder pain and disability index (SPADI). As per the distribution of data, non-parametric tests were employed to analyse the superiority between and within groups with intention-to-treat analysis.

RESULTS: Baseline compatibility was noted in all the key variables (p > 0.05). Both PNF and capsular stretching had a decrease in pain compared to baseline in all capsular pattern positions (p < 0.001), and PNF had more significant improvement compared to control (p < 0.001). Both groups had equal improvement in shoulder ROM (p < 0.001) except abduction (p < 0.05). Both groups had improvements in disability (p < 0.05), and PNF had statistical superiority of improvement (p < 0.001).

CONCLUSIONS: The findings of this study support the potential of PNF intervention for 6 weeks as a treatment for shoulder adhesive capsulitis, showing improvements in pain, ROM and functional disability. However, further multicentre trials with a follow-up design are needed to fully understand the superiority of PNF on shoulder AC, encouraging continued engagement in this area of research.

TRIAL REGISTRATION: The Australian New Zealand Clinical Trial Registry (ACTRN12621001299897). Registered on 27 September 2021, prospectively registered.

PMID:40317031 | DOI:10.1186/s13063-025-08848-0

BMC Med Educ. 2025 May 2;25(1):644. doi: 10.1186/s12909-025-07145-3.

ABSTRACT

BACKGROUND: Antimicrobial resistance, anticipated to cause 10 million deaths and cost $100.2 trillion by 2050, is particularly severe in West Africa. While bacteria naturally resist antibiotics over time, their misuse intensifies resistance. Given the rising trend of antibiotic misuse in Nigeria, especially among the youth, this study explores this misuse among Federal University of Technology Owerri (FUTO)undergraduates.

METHODS: Using a cross-sectional design, the study assessed FUTO undergraduate students’ knowledge, misuse, patterns, and perception of prescription needs, and identified commonly misused antibiotics. We categorized faculties as health-based or non-health-based. From these categories, students were randomly chosen and surveyed using a semi-structured questionnaire that was based on established research.

RESULTS: Out of 400 students surveyed, 60.0% (240 students) displayed inadequate knowledge (Fair) about antibiotic use and resistance, whereas 33.0% (132 students) demonstrated poor knowledge, and only a handful, 7% had good knowledge. More concerning, 67.0% (268 students) reported fair antibiotic usage practices, 26.5% had poor practice with only 6.5% had good practice. The most frequently misused antibiotics were Amoxcillin, Ampiclox, and Tetracycline, often for conditions like Typhoid, Cough, and Catarrh. A significant correlation (p < 0.037) was found between students’ antibiotic knowledge and their usage practices. However, no statistically significant difference in knowledge and practices was observed between students from health and non-health-based faculties.

CONCLUSION: Undergraduate students at FUTO exhibit both a knowledge gap and misuse patterns concerning antibiotics. Implementing educational interventions, like antimicrobial stewardship programs, is essential. Given these findings, especially in the West African context, the inclusion and education of undergraduate students remain crucial.

PMID:40317030 | DOI:10.1186/s12909-025-07145-3

Cardiovasc Diabetol. 2025 May 2;24(1):190. doi: 10.1186/s12933-025-02745-1.

ABSTRACT

BACKGROUND: Sodium-glucose co-transporter 2 (SGLT2) inhibitors are important for treating patients with preserved left ventricular (LV) ejection fraction (LVEF). Several studies have assessed the effects of SGLT2 inhibitors on LV diastolic function, with conflicting results. In this sub-analysis of the Program of Ipragliflozin for Endothelial Dysfunction in Chronic Kidney Disease and Type 2 Diabetes (PROCEED) trial-including patients with type 2 diabetes mellitus (T2DM) and chronic kidney disease (CKD)-we examined the effect of ipragliflozin compared with non-SGLT2 inhibitor standard therapy (control) on changes in the maximum early diastolic velocity to average early diastolic peak velocity (E/e’) ratio (an index of LV diastolic function) via echocardiography.

METHODS: Of the entire PROCEED trial dataset, 57 participants (ipragliflozin group, n = 28; control group, n = 29) with available echocardiography data at baseline and 24 weeks were included. The primary endpoint was the change in the E/e’ ratio from baseline to 24 weeks. The effect of SGLT2 inhibitors on the endpoint was stratified by baseline LVEF, body mass index (BMI), N-terminal pro-brain natriuretic peptide (NT-proBNP) level, estimated glomerular filtration rate (eGFR), and urine albumin-to-creatinine ratio (UACR).

RESULTS: No significant difference in the E/e’ ratio changes was observed between the ipragliflozin and control groups (group difference: – 0.82 [95% CI: – 2.44 to 0.81]; P = 0.317). The E/e’ ratio was unaffected by baseline NT-proBNP, eGFR, and UACR levels. However, ipragliflozin significantly reduced the E/e’ ratio in patients with LVEF ≥ 60% (n = 21, group difference: – 1.42 [- 2.76 to – 0.08]; P = 0.038) or BMI ≥ 25 kg/m² (n = 19, group difference: – 1.95 [- 3.56 to – 0.34]; P = 0.020), but not in those with LVEF < 60% (n = 7, group difference: 1.83 [- 4.48 to 8.14]; P = 0.527) or BMI < 25 kg/m² (n = 9, group difference: 1.34 [- 1.65 to 4.34]; P = 0.363). Significant interactions were noted between patients with LVEF ≥ 60% and < 60% (P_{for interaction=}0.048) and BMI ≥ 25 kg/m² and < 25 kg/m² (P_{for interaction=}0.016).

CONCLUSIONS: In subgroups with higher LVEF and BMI, ipragliflozin improved diastolic function more than standard treatment. These results may partly support the beneficial effect of SGLT2 inhibitors on LV diastolic performance.

PMID:40317024 | DOI:10.1186/s12933-025-02745-1