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Nevin Manimala Statistics

Efficacy of Bacillus Calmette-Guérin (BCG) Vaccination in Reducing the Incidence and Severity of COVID-19 in High-Risk Population (BRIC): a Phase III, Multi-centre, Quadruple-Blind Randomised Control Trial

Infect Dis Ther. 2022 Oct 15. doi: 10.1007/s40121-022-00703-y. Online ahead of print.

ABSTRACT

INTRODUCTION: Universal coverage of vaccines alone cannot be relied upon to protect at-risk populations in lower- and middle-income countries against the impact of the coronavirus disease 2019 (COVID-19) pandemic and newer variants. Live vaccines, including Bacillus Calmette-Guérin (BCG), are being studied for their effectiveness in reducing the incidence and severity of COVID-19 infection.

METHODS: In this multi-centre quadruple-blind, parallel assignment randomised control trial, 495 high-risk group adults (aged 18-60 years) were randomised into BCG and placebo arms and followed up for 9 months from the date of vaccination. The primary outcome was the difference in the incidence of COVID-19 infection at the end of 9 months. Secondary outcomes included the difference in the incidence of severe COVID-19 infections, hospitalisation rates, intensive care unit stay, oxygen requirement and mortality at the end of 9 months. The primary analysis was done on an intention-to-treat basis, while safety analysis was done per protocol.

RESULTS: There was no significant difference in the incidence rates of cartridge-based nucleic acid amplification test (CB-NAAT) positive COVID-19 infection [odds ratio (OR) 1.08, 95% confidence interval (CI) 0.54-2.14] in the two groups, but the BCG arm showed a statistically significant decrease in clinically diagnosed (symptomatic) probable COVID-19 infections (OR 0.38, 95% CI 0.20-0.72). Compared with the BCG arm, significantly more patients developed severe COVID-19 pneumonia (CB-NAAT positive) and required hospitalisation and oxygen in the placebo arm (six versus none; p = 0.03). One patient belonging to the placebo arm required intensive care unit (ICU) stay and died. BCG had a protective efficacy of 62% (95% CI 28-80%) for likely symptomatic COVID-19 infection.

CONCLUSIONS: BCG is protective in reducing the incidence of acute respiratory illness (probable symptomatic COVID-19 infection) and severity of the disease, including hospitalisation, in patients belonging to the high-risk group of COVID-19 infection, and the antibody response persists for quite a long time. A multi-centre study with a larger sample size will help to confirm the findings in this study.

CLINICAL TRIALS REGISTRY: Clinical Trials Registry India (CTRI/2020/07/026668).

PMID:36242739 | DOI:10.1007/s40121-022-00703-y

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Nevin Manimala Statistics

Long-term evolution of quantitative traits in the Drosophila melanogaster species subgroup

Genetica. 2022 Oct 15. doi: 10.1007/s10709-022-00171-9. Online ahead of print.

ABSTRACT

Quantitative genetics aims at untangling the genetic and environmental effects on phenotypic variation. Trait heritability, which summarizes the relative importance of genetic effects, is estimated at the intraspecific level, but theory predicts that heritability could influence long-term evolution of quantitative traits. The phylogenetic signal concept bears resemblance to heritability and it has often been called species-level heritability. Under certain conditions, such as trait neutrality or contribution to phylogenesis, within-species heritability and between-species phylogenetic signal should be correlated. Here, we investigate the potential relationship between these two concepts by examining the evolution of multiple morphological traits for which heritability has been estimated in Drosophila melanogaster. Specifically, we analysed 42 morphological traits in both sexes on a phylogeny inferred from 22 nuclear genes for nine species of the melanogaster subgroup. We used Pagel’s λ as a measurement of phylogenetic signal because it is the least influenced by the number of analysed taxa. Pigmentation traits showed the strongest concordance with the phylogeny, but no correlation was found between phylogenetic signal and heritability estimates mined from the literature. We obtained data for multiple climatic variables inferred from the geographical distribution of each species. Phylogenetic regression of quantitative traits on climatic variables showed a significantly positive correlation with heritability. Convergent selection, the response to which depends on the trait heritability, may have led to the null association between phylogenetic signal and heritability for morphological traits in Drosophila. We discuss the possible causes of discrepancy between both statistics and caution against their confusion in evolutionary biology.

PMID:36242716 | DOI:10.1007/s10709-022-00171-9

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Nevin Manimala Statistics

Understanding heterogeneity of responses to, and optimizing clinical efficacy of, exercise training in older adults: NIH NIA Workshop summary

Geroscience. 2022 Oct 15. doi: 10.1007/s11357-022-00668-3. Online ahead of print.

ABSTRACT

Exercise is a cornerstone of preventive medicine and a promising strategy to intervene on the biology of aging. Variation in the response to exercise is a widely accepted concept that dates back to the 1980s with classic genetic studies identifying sequence variations as modifiers of the VO2max response to training. Since that time, the literature of exercise response variance has been populated with retrospective analyses of existing datasets that are limited by a lack of statistical power from technical error of the measurements and small sample sizes, as well as diffuse outcomes, very few of which have included older adults. Prospective studies that are appropriately designed to interrogate exercise response variation in key outcomes identified a priori and inclusive of individuals over the age of 70 are long overdue. Understanding the underlying intrinsic (e.g., genetics and epigenetics) and extrinsic (e.g., medication use, diet, chronic disease) factors that determine robust versus poor responses to various exercise factors will be used to improve exercise prescription to target the pillars of aging and optimize the clinical efficacy of exercise training in older adults. This review summarizes the proceedings of the NIA-sponsored workshop entitled, “Understanding Heterogeneity of Responses to, and Optimizing Clinical Efficacy of, Exercise Training in Older Adults” and highlights the importance and current state of exercise response variation research, particularly in older adults, prevailing challenges, and future directions.

PMID:36242693 | DOI:10.1007/s11357-022-00668-3

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Nevin Manimala Statistics

Readmission Rates of Patients Discharged on Antipsychotic Polypharmacy Compared to Antipsychotic Monotherapy

Community Ment Health J. 2022 Oct 15. doi: 10.1007/s10597-022-01034-5. Online ahead of print.

ABSTRACT

Antipsychotic medications are used to treat many psychiatric conditions and are paramount for relapse prevention in patients with mental illnesses. Antipsychotic monotherapy (APM) is a commonly recommended approach, however there is no clear consensus on the use of antipsychotic polypharmacy (APP). A single-center retrospective review was conducted comparing readmission rates of behavioral health patients discharged on APP or APM between August 1st 2019 and July 31st 2021. The primary outcome was the one-year psychiatric readmission rate. Secondary outcomes included further readmission time frame stratification, olanzapine equivalent doses, and use of anticholinergic medications. The total readmission rate was 24.5% (24/98) in the APP group compared to 19.1% (107/560) in the APM group (p = 0.22). Patients discharged on APM were not found to have a statistically significant increase in readmission rate compared to patients discharged on APP. Further research is needed to assess the risks and benefits of APP.

PMID:36242684 | DOI:10.1007/s10597-022-01034-5

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Nevin Manimala Statistics

Energy efficiency evaluation, changing trends and determinants of energy productivity growth across South Asian countries: SBM-DEA and Malmquist approach

Environ Sci Pollut Res Int. 2022 Oct 15. doi: 10.1007/s11356-022-23484-w. Online ahead of print.

ABSTRACT

Energy efficiency is widely regarded as the most efficient means of supplying additional energy to meet the rising demand. However, extensive energy consumption causes greenhouse emissions, environmental destruction, and a decrease in energy efficiency (EE). This study investigates the role of energy efficiency and productivity growth in the ecological improvement of South Asia. Moreover, it evaluates the determinants (efficiency change or technology change) of energy productivity change across different SA (South Asian) countries. To estimate the energy efficiency and productivity change, we employed SBM-DEA and Malmquist Productivity Index methods with three inputs (capital stock, labor, and energy consumption), a single desirable output (gross domestic product) and a single undesirable output (CO2 emissions) on the well-extended dataset (2001-2019) for 6 South Asian countries. Furthermore, to check the impact of energy policy (2010) over the study period, the statistical significance of the change in mean scores for energy efficiency and productivity over two time periods (2001-2010 and 2011-2019) and six countries was examined using the Mann-Whitney U and Kruskal-Wallis tests. Results reveal that the average EE score of all 6 SA countries for the study period is 0.7278. This score shows that SA countries still have the potential of 27.22% to improve their energy efficiency to minimize the inputs to get the optimum output level with the least emissions. The primary determinant of energy productivity growth is technological change instead of efficiency. The average energy efficiency level is significantly different for two time periods, 2001-2010 and 2011-2019. Results conclude that energy efficiency and productivity in SA declined over the period, and potential causes are an inefficiency in the energy conversion process, extensive utilization of inputs, and less output growth.

PMID:36242664 | DOI:10.1007/s11356-022-23484-w

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Nevin Manimala Statistics

Pre-industrial sediment concentrations of metals: insights from the Venice lagoon (Italy)

Environ Sci Pollut Res Int. 2022 Oct 15. doi: 10.1007/s11356-022-23378-x. Online ahead of print.

ABSTRACT

This study investigated the occurrence of selected metals and metalloids (As, Cd, Cr, Cu, Hg, Ni, Pb, Zn) in radio-dated sediment cores from a coastal lagoon (Lagoon of Venice, Italy) by critically reviewing and grouping available data. Pre-industrial concentrations (pICs, estimated for the period before the early 1900s) for the Venice lagoon are identified according to the 2σ statistical procedure (2σ-pICs), i.e., the upper bound values of the dataset distribution. Results show the following 2σ-pICs (µg/g, d.w.): As 15,9; Cd 0,6; Cr 38,0; Cu 18,1; Hg 1,1; Ni 32,9; Pb 29,4; Zn 94,5. Most of the estimated 2σ-pICs are comparable to previously assessed background values. In the case of Hg, on the contrary, 2σ-pIC is remarkably higher than background values, reflecting a significant anthropogenic contribution also in the pre-industrial period. The results of this work may support the evaluation of the temporal evolution of metal concentrations in sediments of the Venice lagoon. Results are compared with background concentrations (BC) observed in previous studies conducted in the lagoon and in other areas of the Adriatic Sea, as well as with benchmarks set in Italy for sediment assessment.

PMID:36242659 | DOI:10.1007/s11356-022-23378-x

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Nevin Manimala Statistics

A unified multivariate statistical approach for the assessment of deep groundwater quality of rapidly growing city of Maharashtra Province, India, with potential health risk

Environ Monit Assess. 2022 Oct 15;194(12):891. doi: 10.1007/s10661-022-10572-0.

ABSTRACT

The main aim of this research is to assess the consequences of natural and anthropogenic processes on the groundwater quality of 65 deep aquifers of Nagpur city, Maharashtra Province, India, using a unified multivariate statistical approach. The dominant groundwater type recognized is Ca-HCO3 (recharge waters) in 43.1 and 38.5% of groundwater samples of pre- and post-monsoon seasons, followed by mixed water types. The seasonal distribution of physicochemical parameters shows increase in the concentration of EC, TDS, TH, Mg2+, SO42-, and NO3 signifying the high mineralization and anthropogenic loading from pre- and post-monsoon season respectively. The entropy-weight water quality index categorizes the 84.6% and 75.4% of total samples from pre- and post-monsoon seasons into moderate quality. The multiple linear regression and PCA analysis reveal the masking of rock weathering mechanism by anthropogenic activities. The % of PCA Variance varies from 79 to 83.7% from pre- to post-monsoon season. The high contributions of EC (0.76, 0.72), TDS (0.79, 0.73), TH (0.97, 0.962), Ca2+ (0.84, 0.78), Mg2+ (0.79, 0.83), Cl (0.73, 0.75), and NO3 (0.78, 0.68) in PC1 components expose high salinity and hardness in urban groundwater that signifies the consequences of urbanization on the groundwater regime. About 55.4 and 70.8% of children population as compared to the adult female (53.8%, 69.2%) and male (32.3%, 46.1%) population in PRM and POM respectively were at high non-carcinogenic health threat of NO3-enriched groundwater. The study is beneficial for understanding the variation in groundwater composition due to unplanned urbanization and is very useful for protecting groundwater resources in urban areas.

PMID:36242649 | DOI:10.1007/s10661-022-10572-0

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Nevin Manimala Statistics

Potential of Rice-Flour Jelly Made from High-Amylose Rice as a Dysphagia Diet: Evaluation of Pharyngeal Residue by FEES

Dysphagia. 2022 Oct 15. doi: 10.1007/s00455-022-10529-y. Online ahead of print.

ABSTRACT

Dysphagia diets are recommended to prevent choking and aspiration in people with dysphagia; however, rice-porridge and mashed rice-porridge, which are used as staple foods for people with dysphagia in Japan, are time-consuming to prepare. The National Agriculture and Food Research Organization has found jelly-like food products made from high-amylose rice-flour (rice-flour jelly) to be easy to prepare with a texture suitable for dysphagia diets. To investigate the potential of rice-flour jelly for the dysphagia diet, we evaluated the amount of pharyngeal residue after swallowing rice-flour jelly using fiberoptic endoscopic evaluation of swallowing and compared it with those of rice-porridge, mashed rice-porridge, and fruit jelly. We enrolled 70 participants (43 males and 27 females, aged 32-96 years, median 74.5 years) and evaluated their pharyngeal residue using the Yale Pharyngeal Residue Severity Rating Scale which includes five levels from I (none) to V (severe). Statistical analysis showed that level I was more common in fruit jelly for vallecula residue and pyriform sinus residue, and level III (mild) was more common in rice-porridge for vallecula residue (p < 0.05). No differences of pharyngeal residue were found in rice-flour jelly or mashed rice-porridge. No significant difference was observed in the number of participants with laryngeal penetration or aspiration. Therefore, rice-flour jelly is a suitable alternative to rice-porridge as a staple food for people with dysphagia in terms of food texture.

PMID:36242646 | DOI:10.1007/s00455-022-10529-y

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Nevin Manimala Statistics

A comparative study on a biodegradable hyaluronic acid microneedle patch with a needleless patch for dry skin in atopic dermatitis: a single-blinded, split-body, randomized controlled trial

Arch Dermatol Res. 2022 Oct 15. doi: 10.1007/s00403-022-02400-9. Online ahead of print.

ABSTRACT

To overcome interruption of skin barrier in transdermal drug delivery, the microneedle (MN) patch penetrates the barrier by punching with its MNs. Setting a needleless patch (NL patch) as the control intervention, this study assessed the efficacy of a biodegradable hyaluronic acid MN patch (BHMN patch) for atopic dermatitis (AD) patients with dry skin. Similar two AD lesions were selected from the extremities of a participant. For one lesion, a BHMN patch was attached for 6-8 h on where an aroma cream was applied (BHMN patch group). Simultaneously, an NL patch was attached on the other lesion as in the BHMN patch group (NL patch group). For 2 weeks, the interventions were conducted 3 times a week. The local scoring AD (L-SCORAD) index, the visual analog scale for pruritus and skin dryness, skin hydration, the transepidermal water loss (TEWL), and safety were assessed. Fifteen participants finished this trial with no dropouts. Both groups improved the L-SCORAD index after 2 weeks (p < 0.05), but the score of the BHMN patch group decreased more than that of the NL patch group (p < 0.05). The other outcomes, except for the TEWL, also showed statistical significance in intragroup comparisons. Nevertheless, none of the other outcomes showed statistical significance in intergroup comparisons. The TEWL showed no statistical significance even in intragroup comparison. Recoverable minor adverse events were reported in three cases. Considering the result of L-SCORAD index, the BHMN patch may be effective for ameliorating AD. However, a large-scale confirmatory trial is necessary to reassess other outcomes.Trial Registration: This study was registered with the Clinical Research Information Service, Republic of Korea (Submitted date: 04/01/2022, Registered date: 23/02/2022, The first participant enrollment: 01/12/2021, Registration No. KCT0007037).

PMID:36242622 | DOI:10.1007/s00403-022-02400-9

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Nevin Manimala Statistics

Outcomes of cochlear implantation in children with Usher syndrome: a long-term observation

Eur Arch Otorhinolaryngol. 2022 Oct 15. doi: 10.1007/s00405-022-07670-7. Online ahead of print.

ABSTRACT

PURPOSE: To evaluate auditory performance and speech intelligibility of children with Usher syndrome up to 10 years after cochlear implantation.

METHODS: Thirty-five children with USH were compared to 46 non-syndromic patients regarding age at implantation. Auditory performance and speech intelligibility was assessed with standard tools. Genetic counseling, vestibular tests, imaging studies, and ophthalmological findings were evaluated, depending on the availability.

RESULTS: The mean age of implantation in USH children was 6.3 years (SD 4.6, range 0.3-17.6 years). Post-implantation values of the studied parameters were compared between USH and NS children and presented as follows: PTA = 25.0 dB HL vs. 28.4, CAP = 5.3 vs. 5.1, SIR = 4.1 vs. 3.9, MAIS = 82.3% vs. 80.5%, MUSS = 81.8% vs. 76.6%. There were no statistically significant differences between the USH and NS groups (p > 0.005). USH patients reached a higher score ceiling earlier compared to NS patients. Children implanted before 3 years of age achieved significantly higher results than older children in USH and NS groups (p < 0.005). In all patients with USH, the electroretinogram was abnormal. Vestibular examination was abnormal in 29 of 31 patients with USH1. Imaging studies revealed no inner ear or auditory nerve anomalies in patients with USH.

CONCLUSION: Cochlear implantation successfully improves auditory performance and speech intelligibility in patients with USH, especially those implanted under 3 years of age. The electroretinogram is the only reliable test to establish a diagnosis of USH. Logopedic outcomes are associated with early implantation, and early diagnosis of USH contributes to optimizing speech therapy.

PMID:36242610 | DOI:10.1007/s00405-022-07670-7