Categories
Nevin Manimala Statistics

Visual Acuity and Complications at Age 7 Years Following Bilateral Secondary Intraocular Lens Implantation at 2 to Younger Than 6 Years for Pediatric Aphakia

JAMA Ophthalmol. 2025 May 15. doi: 10.1001/jamaophthalmol.2025.1080. Online ahead of print.

ABSTRACT

IMPORTANCE: The optimal timing for secondary intraocular lens (IOL) implantation in children with bilateral aphakia remains uncertain, with important implications for long-term visual outcomes and the risk of complications such as glaucoma. Determining when to implant to achieve the best visual outcomes while minimizing complications is critical for improving clinical decision-making in pediatric cataract management.

OBJECTIVE: To report the visual acuity (VA) and complications in children with bilateral aphakia after lensectomy for pediatric cataracts, undergoing secondary IOL implantation at different ages.

DESIGN, SETTING, AND PARTICIPANTS: This single-center prospective observational cohort study, conducted from 2014 to 2023, is a 7-year follow-up study. A total of 251 children met the inclusion criteria. After exclusion, 158 children were enrolled in this study. These 158 children (316 eyes) underwent lensectomy before the age of 2 years, followed by secondary IOL implantation between the ages of 2 and younger than 6 years in bilateral pediatric cataracts.

EXPOSURE: Study participants were categorized into 4 groups based on the timing of secondary IOL implantation (2 to <3 years, 3 to <4 years, 4 to <5 years, and 5 to <6 years).

MAIN OUTCOME AND MEASURE: Best-corrected VA (BCVA) outcomes at age 7 years after secondary IOL implantation in children with bilateral pediatric cataracts.

RESULTS: Among the 158 children included in the study, 103 (65.2%) were male. At age 7 years, the mean (SD) BCVA for children who underwent secondary IOL implantation was 0.49 (0.35) logMAR (Snellen equivalent, 20/62) at 2 to younger than 3 years, 0.59 (0.36) logMAR (Snellen equivalent, 20/78) at 3 to younger than 4 years, 0.60 (0.30) logMAR (Snellen equivalent, 20/80) at 4 to younger than 5 years, and 0.65 (0.34) logMAR (Snellen equivalent, 20/89) at 5 to younger than 6 years (P = .20). Glaucoma-related adverse events occurred in 47 eyes in total: 6 eyes (8.8%), 7 eyes (9.0%), 10 eyes (15.6%), and 24 eyes (22.6%) across the groups, respectively, with a statistical difference among the groups (P = .03).

CONCLUSIONS AND RELEVANCE: These findings suggest that secondary IOL implantation performed between the ages of 2 and younger than 6 years following bilateral pediatric cataract lensectomy can achieve comparable visual outcomes; however, the risk of glaucoma increases with older implantation age.

PMID:40372731 | DOI:10.1001/jamaophthalmol.2025.1080

Categories
Nevin Manimala Statistics

Patient-Reported Outcomes With Stereotactic Intensity Modulated Radiotherapy After Radical Prostatectomy: A Nonrandomized Clinical Trial

JAMA Oncol. 2025 May 15. doi: 10.1001/jamaoncol.2025.1059. Online ahead of print.

ABSTRACT

IMPORTANCE: Postoperative radiotherapy remains underused for men with biochemical recurrence or adverse pathological features after radical prostatectomy (RP). Stereotactic body radiotherapy (SBRT) may improve utilization and poses potential radiobiological advantages.

OBJECTIVE: To evaluate physician-reported late toxic effects and 2-year patient-reported outcomes (PROs) following post-RP SBRT.

DESIGN, SETTING, AND PARTICIPANTS: This phase 2, single-arm trial was conducted in 2 academic centers in the US and included a comparator cohort. Men with post-RP prostate-specific antigen greater than 0.03 ng/mL or adverse pathologic features were included. Data were collected from February 2018 to March 2021, and data were analyzed from January to October 2024.

INTERVENTIONS: SBRT delivered at 30 to 34 Gy in 5 fractions to the prostate bed. Nodal irradiation, boost to gross disease, and/or hormonal therapy were delivered per physician discretion.

MAIN OUTCOMES AND MEASURES: Late toxic effects (more than 90 days after treatment) were graded according to Common Terminology Criteria for Adverse Events version 4.03. PROs were measured using Expanded Prostate Cancer Index-26. The proportion of men whose PROs had decrements greater than twice the threshold for minimal clinically important difference (MCID) at any point during the first 2 years were evaluated. The longitudinal PROs for men receiving SBRT was compared with a cohort of 200 men receiving postoperative conventionally fractionated radiotherapy (CFRT) using logistic regression, while adjusting for baseline scores, age, and receipt of nodal irradiation.

RESULTS: Of 100 patients treated with post-RP SBRT, the median (IQR) age was 68.5 (63.9-71.4) years, and the median (IQR) follow-up was 43 (37-53) months. Cumulative incidence of late grade 2 and 3 genitourinary toxic effects was 25% and 4%, respectively, and of late grade 2 and 3 gastrointestinal tract toxic effects was 3% and 3%, respectively. The proportion of patients with decrements more than 2-fold the MCID in PROs was 38.9% (37 of 95) for urinary incontinence, 17.9% (17 of 95) for urinary irritation, and 34.1% (31 of 91) for bowel function. Compared with the CFRT cohort, the adjusted odds ratio for patients receiving SBRT experiencing decrements more than 2-fold the MCID was 1.55 (95% CI, 0.87-2.76; P = .14) for urinary incontinence, 0.94 (95% CI, 0.46-1.94; P = .87) for urinary irritation, and 1.03 (95% CI, 0.57-1.84; P = .93) for bowel function.

CONCLUSIONS AND RELEVANCE: In this nonrandomized clinical trial, post-RP SBRT was well-tolerated, with no measurably different decline in urinary or bowel PROs through 2 years compared with CFRT. Randomized studies and longer follow-up will better define the toxic effects and efficacy profile of post-RP SBRT.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03541850.

PMID:40372727 | DOI:10.1001/jamaoncol.2025.1059

Categories
Nevin Manimala Statistics

Effect of rituximab on long-term damage acquisition in patients with systemic lupus erythematosus

Rheumatology (Oxford). 2025 May 15:keaf248. doi: 10.1093/rheumatology/keaf248. Online ahead of print.

ABSTRACT

OBJECTIVES: B cell depletion therapy has been used for over two decades to treat systemic lupus erythematosus (SLE), but there is a lack of studies reporting its impact on damage progression. This study aims to assess the effectiveness of rituximab in slowing damage acquisition.

METHODS: We selected 380 patients 190 treated with rituximab and 190 controls, based on matched sex and age of onset, with standard immunosuppressive therapies-to compare the damage they developed, assessed by the Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index (SLICC/ACR DI). A secondary analysis of 111 patients was conducted to evaluate DI progression.

RESULTS: The majority of patients were female (94.1%) and caucasian (45.4%). Severe disease manifestations and higher titers of anti-dsDNA antibodies (86 U/ml vs 62 U/ml; p= 0.012) were seen in the rituximab group, in which SLICC/ACR DI was also higher (1.3 vs 0.9; p= 0,02). In the secondary analysis the SLICC/ACR DI mean had no statistical difference between the two groups (0.4 vs 0,6; p= 0.33), but we identified a statistical significance between the two groups regarding their DI progression (58.2% in the control group vs 44.2% in the rituximab).

CONCLUSION: As an effective B cell depleting therapy, rituximab is a valid therapeutic option for SLE patients, especially in those with refractory or life-threatening manifestations. While patients treated with rituximab initially had higher damage, their rate of damage progression was slower compared with those receiving standard therapies.

PMID:40372703 | DOI:10.1093/rheumatology/keaf248

Categories
Nevin Manimala Statistics

Assessment of total mercury (Hg) in soil, sediment, and tilapia fish (Oreochromis niloticus) and health risk assessment among residents of Kitwe mining area, Zambia

Environ Sci Pollut Res Int. 2025 May 15. doi: 10.1007/s11356-025-36506-0. Online ahead of print.

ABSTRACT

Mercury (Hg) is a heavy metal of global concern because of its persistence in the environment and its ability to bioaccumulate and biomagnify in ecosystems. Despite evidence of extensive environmental pollution in the Copperbelt Province, few studies have investigated Hg contamination in the Kafue River and its tributaries in Kitwe District, Zambia. Total Hg concentrations were determined in soil, sediments, and tilapia by inductively coupled plasma mass spectrometer (ICP-MS) from the mining areas and non-mining areas. There were significant differences in the population means for soil samples (Mean (mining) = 1.066, Mean (non-mining) = 0.041, p ≤ 0.05 ) and sediment samples (Mean (mining) = 1.304, Mean (non-mining) = 0.034), p ≤ 0.05 ) between mining and non-mining areas. There were also statistically significant differences in the population means for fish samples (Mean (mining) = 0.015, Mean (non-mining) = 0.007, p ≤ 0.05 ) between mining and non-mining areas. The levels of Hg in the soil and sediments from the mining area were higher than the United States Environmental Protection Agency (USEPA) reference values of 0.3 mg/kg and 0.2 mg/kg, respectively. There was a weak positive correlation between the size of the fish (length) and Hg accumulation in the Kitwe mining area (r = 0.232, P = 0.1166). The observed correlation between Hg accumulation and length of fish was not statistically significant (P > 0.05). The EDI from the consumption of fish from the mining area was below the USEPA and WHO/FAO maximum tolerable daily intake of 0.1 µg/kg/day and 0.23 µg/kg, respectively. The THQ < 1 was also reported in the current study, suggesting that the exposure level may not cause adverse health effects during a lifetime in the human population. Although the EDI and THQ < 1 in the current study were below the USEPA and WHO/FAO maximum tolerable limit, the presence of Hg in fish in this area must be monitored due to its ability to bioaccumulate in large and predatory fish. The lower EDI value reported in the current study might be attributed to the smaller size of the tilapia fish specimens, resulting in low bioaccumulation of Hg. Since the Hg levels in sediments were above the USEPA limit, we recommend further studies on the bioavailability of Hg in humans and other fish species in the region, particularly carnivorous fish, due to Hg biomagnification to offer a clearer perspective on the environmental and health impacts.

PMID:40372695 | DOI:10.1007/s11356-025-36506-0

Categories
Nevin Manimala Statistics

Evaluating the surface water quality after the rupture of an iron mining tailings

Environ Sci Pollut Res Int. 2025 May 15. doi: 10.1007/s11356-025-36437-w. Online ahead of print.

ABSTRACT

The aim of this article is to assess whether the collapse of the Fundão tailings dam still impacts the surface water quality of the Doce River in the state of Minas Gerais (Brazil). The records of 15 water quality parameters were evaluated, comparing data from before and after the accident. Nine sampling points were selected, six of which corresponded to water intakes for the water supply systems. The records showed that after the collapse of the Fundão Dam, there was an increase in the percentage of non-conforming values for dissolved Fe, dissolved Al, true color, turbidity, and total suspended solids, but a reduction in total Mn and total Pb, based on the Normative Consideration COPAM/2008. The time series analysis showed no trends, with Levene’s test indicating variance changes only for dissolved Fe, total dissolved solids, and dissolved Al. Mann-Whitney tests revealed no median changes in key parameters after the Fundão Dam collapse. For the seven trace metals evaluated (As, Cd, Cr, Pb, Hg, Ni and Zn), the Mann-Whitney and Pettitt tests allow us to infer that there was a change in the median concentrations and an abrupt change in the data series after the dam rupture. It is not possible to associate any plausible cause for the changes observed in some tests and monitoring stations in the records prior to the accident. For records after the accident, the prospect of the Doce River’s recovery still lacks greater statistical robustness, emphasizing the relevance of maintenance of water quality monitoring stations in the Doce River channel.

PMID:40372694 | DOI:10.1007/s11356-025-36437-w

Categories
Nevin Manimala Statistics

Application of response surface methodology on performance and emission characteristics of a diesel engine fueled with diesel, pentanol, and biogas

Environ Sci Pollut Res Int. 2025 May 15. doi: 10.1007/s11356-025-36505-1. Online ahead of print.

ABSTRACT

The current investigation’s objective is to compare various pentanol/biogas/diesel fuel mixes’ performance and exhaust parameters in a dual fuel engine. The varied flow rates of gaseous fuel (10, 20, and 30 L per minute) and pentanol fractions (10, 15, and 20%) in conventional diesel at various engine loads (20, 60, and 100%) were studied. Response surface approach was used to assess the researched variables in order to get the best model. The entire range of the proposed multivariate models was statistically significant in the current analysis, demonstrating the great accuracy of the models. Additionally, the values of the independent parameters were defined using the desirability technique to get the highest performance and the lowest engine-out emissions. As per the modeling results, the ideal operation condition was found at an engine load of 83%, a pentanol ratio of 10%, and a biogas flow rate of 30 L per minute. In particular, the use of biogas instead of fossil fuels is valuable both economically and in terms of climate studies. The projected values for the relevant reaction parameters at the recommended point were 22% brake thermal efficiency, 56 ppm unburned hydrocarbon emissions, 0.09% carbon monoxide emissions, 102 ppm nitrogen oxides emissions, and 24% emitted smoke. The response surface approach might be utilized to properly model and optimize a diesel engine that runs on a ternary mix, as demonstrated by the high desirability of 0.74 for derived models. The fuel used can be utilized to minimize the pollution coming out of tailpipe of diesel engines and also helps in enhancing the performance of the engine as compared to natural diesel.

PMID:40372693 | DOI:10.1007/s11356-025-36505-1

Categories
Nevin Manimala Statistics

Application of DNA Methylome Analysis to Patients with ME/CFS

Methods Mol Biol. 2025;2920:141-160. doi: 10.1007/978-1-0716-4498-0_9.

ABSTRACT

Myalgic encephalomyelitis/chronic fatigue syndrome is a post-viral/stressor syndrome that has a complex pathophysiology reflecting multiple changes in many cell transcripts and proteins. These changes imply a change in the regulation of gene expression at the level of the DNA. A significant contributor to this is the modulation of the methylation at specific sites within regulatory regions throughout the genome that can either enhance or dampen expression depending on whether methylation is reduced or increased, respectively. DNA methylation can be analyzed by array technology or by reduced representation bisulfite sequencing (RRBS) or whole genome bisulfite sequencing (WGBS). This chapter describes RRBS, which has been very effective at analyzing the methylation states of ME/CFS patients both in single time point studies and in longitudinal studies with individual patients, for example, following a relapse recovery cycle. Here, we describe the step-by-step experimental methodology of how RRBS has been applied to DNA samples from ME/CFS patients and the analytical platforms used to detect the methylation changes that are statistically significant between patients and health controls. It has the potential to provide molecular biomarkers for a diagnostic test or to follow the progression of the condition in patients or through relapse/recovery fluctuations that occur frequently through the ongoing course of the disease. When effective therapies become available it has the potential to monitor the effectiveness on individual patients under treatment.

PMID:40372682 | DOI:10.1007/978-1-0716-4498-0_9

Categories
Nevin Manimala Statistics

Development and initial validation of the health-related quality of life pictorial inventory for children (HEALTH-PIC)

Qual Life Res. 2025 May 15. doi: 10.1007/s11136-025-03988-x. Online ahead of print.

ABSTRACT

PURPOSE: This 3-study paper aimed to develop and validate a self-reported Health-Related Quality of Life Pictorial Inventory for Early Childhood Children (HEALTH-PIC). The scale was designed to overcome existing barriers of parent-proxy response styles such as observation bias and offer an alternative to age-suited literary questionnaires to assess self-reported health-related quality of life, including physical health, emotional health, social health and school health in early childhood.

METHODS: Each study targeted a specific aspect of scale development, employing distinct samples to refine and validate the inventory. Study 1 involved item development/revision, which utilized a panel of 10 experts (Meanage = 34.8, SD = 4.9) and 25 parents (Meanage = 38.9; SD = 4.1) via the Delphi method to revise the scale and establish agreement. Study 2 is a cross-sectional study that invited a sample of 22 primary school students (Meanage = 6.18, SD = 0.39) and 20 kindergarten students (Meanage = 4.55, SD = 0.50) to establish face validity amongst primary respondents. Finally, Study 3 is a cross-sectional study that invited 342 parent and child (Meanage = 6.30, SD = 1.31) dyads to complete the HEALTH-PIC and reference health-related quality of life (HRQoL) questionnaires to establish the questionnaire’s factorial, concurrent, discriminant and criterion validity in addition to internal consistency.

RESULTS: Scale items in Study 1 were developed alongside experts and parents with a strong theoretical and statistical support calculated using Aiken’s agreement (Aiken’s V p < 0.05), ensuring that the items were clear, accurate and applicable for children. In Study 2, we ensured that primary respondents of different ages were able to accurately identify the pictorial images (Aiken’s V p < 0.05) and complete the questionnaire when the scripted instructions were read aloud. In Study 3, structural equation modelling of the HEALTH-PIC demonstrated a robust factor structure (CFI and TLI > 0.99; RMSEA and SRMR ≤ 0.08), concurrent validity, discriminant validity, criterion validity and an acceptable level of internal consistency (i.e., Cronbach’s α = 0.60-0.66).

CONCLUSION: The findings of the three studies provide preliminary evidence to support the content validity and construct validity of the HEALTH-PIC. This novel pictorial scale not only provides a reliable and valid assessment of the multidimensional aspects of health-related quality of life among children but can also overcome existing barriers of parent-proxy or age-suited questionnaires.

PMID:40372663 | DOI:10.1007/s11136-025-03988-x

Categories
Nevin Manimala Statistics

Do Rental Assistance Programs Relieve Overcrowding for Children?

J Urban Health. 2025 May 15. doi: 10.1007/s11524-025-00979-8. Online ahead of print.

ABSTRACT

Crowded living conditions are associated with negative health outcomes, particularly for children. Federal rental assistance may reduce household crowding by improving access to affordable housing for low-income families. We leveraged NHANES data linked with HUD administrative rental assistance records to examine relationships between different forms of HUD rental assistance and multiple measures of crowding for households with children. We found a statistically significant reduction in the odds of crowding for those currently receiving HUD assistance compared to a control group who entered rental assistance within 2 years of their NHANES interview (95% CI, 0.39 to 0.93). The specific relationships between rental assistance and crowding and the magnitude of these associations varied by rental assistance type (public housing, multi-family, and vouchers). Fewer than 1 in 4 eligible households receive rental assistance. Our findings suggest that expanding access to this resource can reduce household crowding and its adverse impacts on health and well-being.

PMID:40372662 | DOI:10.1007/s11524-025-00979-8

Categories
Nevin Manimala Statistics

Early in-hospital use of SGLT2i in heart failure patients with ischemic etiology

Cardiovasc Drugs Ther. 2025 May 15. doi: 10.1007/s10557-025-07714-0. Online ahead of print.

ABSTRACT

PURPOSE: SGLT2i role in the treatment of heart failure (HF) regardless of clinical presentation and left ventricular ejection fraction (LVEF) has been widely proven and real-world data regarding patients with HF and ischemic heart disease (IHD) and, in particular with recent acute coronary syndrome (ACS) and de novo HF, are lacking. We aim to evaluate the occurrence of the composite of cardiovascular death (CV)/ HF hospitalization (HFH), all-cause death, CV death and HFH at 6 months follow up, in patients with HF due to IHD as well as in recent ACS who introduced SGLT2i during the index hospitalization.

METHODS: The present is an observational, prospective, single center study, enrolling patients with a diagnosis of HF due to IHD as primary etiology. According to SGLT2i introduction timing, two groups were created: pre-discharge (G1) or post-discharge (G2) introduction. A sub-analysis in patients admitted due to ACS has been performed.

RESULTS: A total of 222 consecutive patients have been enrolled from April 2022 to April 2024 and were followed-up for a period of 6 months. At multivariate Cox regression analysis, statistically significant differences have been observed between the two groups in terms of the composite CV death/HFH (HR = 0.24; 95%CI [0.101-0.564]; p = 0.001), all-cause death (HR = 0.27; 95% CI [0.100-0.725]; p = 0.009), CV death (HR = 0.32; 95%CI [0.101-0.999] p = 0.045) and HFH (HR = 0.31; 95%CI [0.098-0.963]; p = 0.043). Patients with ACS treated with SGLT2i before discharge showed a reduced rate of CV death/HFH (log-rank p = 0.008), CV death (log-rank p = 0.015) and all-cause death (log-rank p = 0.005) compared to patients who were not treated with SGLT2i before discharge. In this subpopulation, no differences have been observed in terms of HFH (log-rank p = 0.155). Significant differences in term of CV death/HFH (log-rank p = 0.039) have been observed in de novo HF patients, but not in terms of the other study endpoints.

CONCLUSIONS: The early in-hospital introduction of SGLT2i reduced the occurrence of the composite CV death/HFH, all-cause death, CV death and HFH in patients with ischemic cardiomyopathy. In the subgroup analysis of patients admitted due to ACS, the introduction of SGLT2i during the index hospitalization resulted in a significant reduction of the composite CV death/HFH, CV death and all-cause death, but not in HFH. The same therapeutic strategy resulted in reduced rate of CV death/HFH in the de novo HF subpopulation.

PMID:40372630 | DOI:10.1007/s10557-025-07714-0