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Nevin Manimala Statistics

Significance of Arterial Spin Labeling for Reducing Biopsies in Patients With Kidney Allograft Dysfunction

J Magn Reson Imaging. 2023 Jul 28. doi: 10.1002/jmri.28926. Online ahead of print.

ABSTRACT

BACKGROUND: Although biopsy is often entailed for managing patients with kidney allograft dysfunction, it is associated with potential complications of severe hemorrhage. Arterial spin labeling (ASL) is a non-invasive technique that assesses tissue perfusion.

PURPOSE: To assess the utility of ASL for the discrimination of patients with post-transplant allograft dysfunction who do not need biopsy from those who need.

STUDY TYPE: Prospective.

SUBJECTS: Forty-six patients (34 males/12 females, aged 38.8 ± 9.5 years) with kidney allograft dysfunction, including 31 in which biopsy directly lead to changes in management (NECESSARY group) and 15 in which clinical management did not alter after biopsy (UNNECESSARY group).

FIELD STRENGTH/SEQUENCE: 3.0 T and 3D fast-spin echo sequence.

ASSESSMENT: All patients underwent both ASL scan and biopsies. The serum creatinine, proteinuria, pathologic results, and cortical ASL readings were obtained and compared between the two groups.

STATISTICAL ANALYSES: Chi-square test, independent student t-test, Mann-Whitney U test, receiver-operating characteristic curve. A two-tailed P < 0.05 denoted statistical significance.

RESULTS: The NECESSARY group presented with significantly elevated serum creatinine as compared with the UNNECESSARY group (1.87 ± 0.56 mg/dL vs. 1.31 ± 0.37 mg/dL). The acute composite score was significantly higher in the NECESSARY group than that in the UNNECESSARY group (7 [4-8] vs. 1 [0-2]). Cortical ASL in the NECESSARY group was significantly decreased as compared with the UNNECESSARY group (108.06 [69.96-134.92] mL/min/100 g vs. 153.48 [113.19-160.37] mL/min/100 g). Serum creatinine differentiated UNNCESSARY group from the NECESSARY group with an area under the curve (AUC) and specificity of 0.79 and 54.84%, respectively. By comparison, the cortical ASL yielded an AUC of 0.75 and a specificity of 70.97%. Notably, the specificity was increased to 90.30% by combined use of serum creatinine and cortical ASL.

DATA CONCLUSION: The combined use of ASL and serum creatinine yielded a high specificity for selecting patients who may not need allograft biopsy.

LEVEL OF EVIDENCE: 2 TECHNICAL EFFICACY: Stage 3.

PMID:37515309 | DOI:10.1002/jmri.28926

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Nevin Manimala Statistics

Maternal Fever and Reduced Fetal Movement as Predictive Risk Factors for Adverse Neonatal Outcome in Cases of Congenital SARS-CoV-2 Infection: A Meta-Analysis of Individual Participant Data from Case Reports and Case Series

Viruses. 2023 Jul 24;15(7):1615. doi: 10.3390/v15071615.

ABSTRACT

OBJECTIVES: To determine risk factors for primary and secondary adverse neonatal outcomes in newborns with congenital SARS-CoV-2 infection.

DATA SOURCES: PubMed/MEDLINE and Google Scholar from January 2020 to January 2022.

STUDY ELIGIBILITY CRITERIA: newborns delivered after 24 weeks of gestation with confirmed/possible congenital SARS-CoV-2 infection, according to standard classification criteria.

METHODS: Execution of the IPD analyses followed the PRISMA-IPD statement. Univariate non-parametric tests compared numerical data distributions. Fisher’s exact or Chi-square test determined categorical variables’ statistical significance. Multivariate logistic regression revealed risk factors for adverse neonatal outcome.

RESULTS: Maternal fever was associated with symptomatic congenital infection (OR: 4.55, 95% CI: 1.33-15.57). Two-thirds of women that reported decreased fetal movements were diagnosed with IUFD (p-value = 0.001). Reduced fetal movement increased the risk of intrauterine fetal death by 7.84 times (p-value = 0.016, 95% CI: 2.23-27.5). The risk of stillbirth decreased with gestational age at the time of maternal infection (p-value < 0.05, OR: 0.87, 95% CI: 0.79-0.97).

CONCLUSIONS: Maternal fever and perception of reduced fetal movement may be predictive risk factors for adverse pregnancy outcome in cases with congenital SARS-CoV-2 infection.

PMID:37515301 | DOI:10.3390/v15071615

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Nevin Manimala Statistics

The Prospective COVID-19 Post-Immunization Serological Cohort in Munich (KoCo-Impf): Risk Factors and Determinants of Immune Response in Healthcare Workers

Viruses. 2023 Jul 18;15(7):1574. doi: 10.3390/v15071574.

ABSTRACT

Antibody studies analyze immune responses to SARS-CoV-2 vaccination and infection, which is crucial for selecting vaccination strategies. In the KoCo-Impf study, conducted between 16 June and 16 December 2021, 6088 participants aged 18 and above from Munich were recruited to monitor antibodies, particularly in healthcare workers (HCWs) at higher risk of infection. Roche Elecsys® Anti-SARS-CoV-2 assays on dried blood spots were used to detect prior infections (anti-Nucleocapsid antibodies) and to indicate combinations of vaccinations/infections (anti-Spike antibodies). The anti-Spike seroprevalence was 94.7%, whereas, for anti-Nucleocapsid, it was only 6.9%. HCW status and contact with SARS-CoV-2-positive individuals were identified as infection risk factors, while vaccination and current smoking were associated with reduced risk. Older age correlated with higher anti-Nucleocapsid antibody levels, while vaccination and current smoking decreased the response. Vaccination alone or combined with infection led to higher anti-Spike antibody levels. Increasing time since the second vaccination, advancing age, and current smoking reduced the anti-Spike response. The cumulative number of cases in Munich affected the anti-Spike response over time but had no impact on anti-Nucleocapsid antibody development/seropositivity. Due to the significantly higher infection risk faced by HCWs and the limited number of significant risk factors, it is suggested that all HCWs require protection regardless of individual traits.

PMID:37515259 | DOI:10.3390/v15071574

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A Sequential Cross-Sectional Analysis Producing Robust Weekly COVID-19 Rates for South East Asian Countries

Viruses. 2023 Jul 18;15(7):1572. doi: 10.3390/v15071572.

ABSTRACT

The COVID-19 pandemic has expanded fast over the world, affecting millions of people and generating serious health, social, and economic consequences. All South East Asian countries have experienced the pandemic, with various degrees of intensity and response. As the pandemic progresses, it is important to track and analyse disease trends and patterns to guide public health policy and treatments. In this paper, we carry out a sequential cross-sectional study to produce reliable weekly COVID-19 death (out of cases) rates for South East Asian countries for the calendar years 2020, 2021, and 2022. The main objectives of this study are to characterise the trends and patterns of COVID-19 death rates in South East Asian countries through time, as well as compare COVID-19 rates among countries and regions in South East Asia. Our raw data are (daily) case and death counts acquired from “Our World in Data”, which, however, for some countries and time periods, suffer from sparsity (zero or small counts), and therefore require a modelling approach where information is adaptively borrowed from the overall dataset where required. Therefore, a sequential cross-sectional design will be utilised, that will involve examining the data week by week, across all countries. Methodologically, this is achieved through a two-stage random effect shrinkage approach, with estimation facilitated by nonparametric maximum likelihood.

PMID:37515258 | DOI:10.3390/v15071572

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Nevin Manimala Statistics

Atypical Hepatitis B Virus Serology Profile-Hepatitis B Surface Antigen-Positive/Hepatitis B Core Antibody-Negative-In Hepatitis B Virus/HIV Coinfected Individuals in Botswana

Viruses. 2023 Jul 13;15(7):1544. doi: 10.3390/v15071544.

ABSTRACT

(1) Background: Hepatitis B core antibodies (anti-HBc) are a marker of hepatitis B virus (HBV) exposure; hence, a normal HBV serology profile is characterized by HBV surface antigen (HBsAg) and anti-HBc positivity. However, atypical HBV serologies occur, and we aimed to determine the prevalence of an atypical profile (HBsAg+/anti-HBc-) in a cohort of people with HIV-1 (PWH) in Botswana. (2) Methods: Plasma samples from an HIV-1 cohort in Botswana (2013-2018) were used. The samples were screened for HBsAg and anti-HBc. Next-generation sequencing was performed using the GridION platform. The Wilcoxon rank-sum test and Chi-squared tests were used for the comparison of continuous and categorical variables, respectively. (3) Results: HBsAg+/anti-HBc- prevalence was 13.7% (95% CI 10.1-18.4) (36/263). HBsAg+/anti-HBc- participants were significantly younger (p < 0.001), female (p = 0.02) and ART-naïve (p = 0.04) and had a detectable HIV viral load (p = 0.02). There was no statistically significant difference in the number of mutations observed in participants with HBsAg+/anti-HBc- vs. those with HBsAg+/anti-HBc+ serology. (4) Conclusions: We report a high HBsAg+/anti-HBc- atypical serology profile prevalence among PWH in Botswana. We caution against HBV-testing algorithms that consider only anti-HBc+ samples for HBsAg testing, as they are likely to underestimate HBV prevalence. Studies to elucidate the mechanisms and implications of this profile are warranted.

PMID:37515230 | DOI:10.3390/v15071544

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Impact of Alteplase on Mortality in Critically Ill Patients with COVID-19 and Pulmonary Embolism

Viruses. 2023 Jul 7;15(7):1513. doi: 10.3390/v15071513.

ABSTRACT

COVID-19 is an independent risk factor for pulmonary embolism (PE). Little is known about alteplase therapy in this patient group. A retrospective study analyzed 74 patients with PE and acute respiratory distress syndrome (ARDS) due to COVID-19 who were hospitalized in the intensive care unit in 2021. Patients with or without confirmed right heart thrombi (RHT) were treated with unfractionated heparin or alteplase. The mortality rate in patients with RHT treated with heparin was 100% compared to 37.9% and 55.2% in those treated with alteplase without RHT and alteplase with RHT, respectively. The risk of death in the alteplase group increased with delayed thrombolysis (p = 0.009, odds ratio (OR) = 1.73 95% CI (confidence interval) 1.14-2.62), increased D-dimer concentration (p = 0.02, OR = 1.43 95% CI 1.06-1.93), and decreased PaO2/FiO2 ratio (p = 0.001, OR = 0.56 95% CI 0.41-0.78). The receiver operating characteristic method determined that a 1-day delay in thrombolytic treatment, D-dimer concentration >5.844 mg/L, and PaO2/FiO2 <144 mmHg predicted a fatal outcome. The risk of death in patients with severe COVID-19 with ARDS and PE increases with higher D-dimer levels, decreased PaO2/FiO2, and delayed thrombolytic treatment. Thrombolysis seems to be treatment of choice in severe COVID-19 with PE and RHT. It should be carried out as soon as possible after the diagnosis is established.

PMID:37515199 | DOI:10.3390/v15071513

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Preoperative Biomarkers and Survival in Chinese Breast Cancer Patients with HIV: A Propensity-Score-Matched-Cohort Study

Viruses. 2023 Jun 30;15(7):1490. doi: 10.3390/v15071490.

ABSTRACT

BACKGROUND: China initiated its national free antiretroviral therapy program in 2004 and saw a dramatic decline in mortality among the population with HIV. However, the morbidity of non-AIDS-defining cancers such as breast cancer is steadily growing as life expectancy improves. The aim of this study was to investigate the clinical characteristics and prognosis of breast cancer patients with HIV in China.

MATERIALS AND METHODS: Data from 21 breast cancer patients with HIV and 396 breast cancer patients without HIV treated at the Shanghai public health clinical center from 2014-2022 was collected. After propensity score matching, 21 paired patients in the two groups were obtained and compared. The optimal cut-off value of preoperative biomarkers for recurrence was determined via maximally selected log-rank statistics. Preoperative biomarkers were categorized into high and low groups, based on the best cut-off values and compared using Kaplan-Meier survival curves and the log-rank test. The Cox proportional hazards regression model was used to perform univariate and multivariate analyses.

RESULTS: The median follow-up time was 38 months (IQR: 20-68 months) for the propensity-score-matching cohort. The progression-free survival at 1, 2 and 3 years for patients with and without HIV were 74.51%, 67.74%, and 37.63% and 95.24%, 95.24%, and 90.48%, respectively. The overall survival for patients with HIV at 1, 2 and 3 years were 94.44%, 76.74%, and 42.63%. After multivariate analysis, Only HIV status (hazard ratios (HRs) = 6.83, 95% [confidence intervals (CI)] 1.22-38.12) were associated with progression-free survival. Based on the best cut-off value, CD8 showed discriminative value for overall survival (p = 0.04), whereas four variables, the lymphocyte-to-monocyte ratio (p = 0.02), platelet-to-lymphocyte ratio (p = 0.03), CD3 (p = 0.01) and CD8 (p < 0.01) were suggested be significant for progression-free survival. The univariate analysis suggested that CD3 (HRs = 0.10, 95% [CI] 0.01-0.90) and lymphocyte-to-monocyte ratio (HRs = 0.22, 95% [CI] 0.05-0.93) were identified as significant predictors for progression-free survival.

CONCLUSION: In this study, breast cancer in patients with HIV in China reflected a more aggressive nature with a more advanced diagnostic stage and worse prognosis. Moreover, preoperative immune and inflammatory biomarkers might play a role in the prognosis of breast cancer patients with HIV.

PMID:37515177 | DOI:10.3390/v15071490

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An Early SARS-CoV-2 Omicron Outbreak in a Dormitory in Saint Petersburg, Russia

Viruses. 2023 Jun 22;15(7):1415. doi: 10.3390/v15071415.

ABSTRACT

The Omicron variant of SARS-CoV-2 rapidly spread worldwide in late 2021-early 2022, displacing the previously prevalent Delta variant. Before 16 December 2021, community transmission had already been observed in tens of countries globally. However, in Russia, the majority of reported cases at that time had been sporadic and associated with travel. Here, we report an Omicron outbreak at a student dormitory in Saint Petersburg between 16-29 December 2021, which was the earliest known instance of a large-scale community transmission in Russia. Out of the 465 sampled residents of the dormitory, 180 (38.7%) tested PCR-positive. Among the 118 residents for whom the variant had been tested by whole-genome sequencing, 111 (94.1%) were found to carry the Omicron variant. Among these 111 residents, 60 (54.1%) were vaccinated or had reported a previous infection of COVID-19. Phylogenetic analysis confirmed that the outbreak was caused by a single introduction of the BA.1.1 sub-lineage of the Omicron variant. The dormitory-derived clade constituted a significant proportion of BA.1.1 samples in Saint Petersburg and has spread to other regions of Russia and even to other countries. The rapid spread of the Omicron variant in a population with preexisting immunity to previous variants underlines its propensity for immune evasion.

PMID:37515103 | DOI:10.3390/v15071415

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Influence of the Single Nucleotide Polymorphisms rs12252 and rs34481144 in IFITM3 on the Antibody Response after Vaccination against COVID-19

Vaccines (Basel). 2023 Jul 19;11(7):1257. doi: 10.3390/vaccines11071257.

ABSTRACT

The COVID-19 mRNA vaccine is the first mRNA vaccine approved for human administration by both the U.S. Food and Drug Administration and the European Medicines Agency. Studies have shown that the immune response and the decay of immunity after vaccination with the COVID-19 vaccines are variable within a population. Host genetic factors probably contribute to this variability. In this study, we investigated the effect of the single-nucleotide polymorphisms rs12252 and rs34481144 in the interferon-induced transmembrane protein (IFITM) 3 gene on the humoral immune response after vaccination against COVID-19 with mRNA vaccines. Blood samples were collected from 1893 healthcare workers and medical students at multiple time points post-vaccination and antibody titers against the SARS-CoV-2 S1 protein receptor binding domain were determined at all time points. All participants were genotyped for the rs34481144 and rs12252 polymorphisms in the IFITM3 gene. After the second and third vaccinations, antibody titer levels increased at one month and decreased at six months (p < 0.0001) and were higher after the booster vaccination than after the basic immunization (p < 0.0001). Participants vaccinated with mRNA-1273 had a higher humoral immune response than participants vaccinated with BNT162b2. rs12252 had no effect on the antibody response. In contrast, carriers of the GG genotype in rs34481144 vaccinated with BNT162b2 had a lower humoral immune response compared to A allele carriers, which reached statistical significance on the day of the second vaccination (p = 0.03) and one month after the second vaccination (p = 0.04). Further studies on the influence of rs12252 and rs34481144 on the humoral immune response after vaccination against COVID-19 are needed.

PMID:37515072 | DOI:10.3390/vaccines11071257

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Nevin Manimala Statistics

Study protocol: biomechanical testing, finite element analysis and prospective, randomized, clinical study of single screw cephalomedullary nailing versus integrated dual interlocking screw fixation for unstable (31A21-3) intertrochanteric fractures in patients > 70 years old

J Orthop Surg Res. 2023 Jul 28;18(1):542. doi: 10.1186/s13018-023-04009-8.

ABSTRACT

BACKGROUND: Hip fractures are an increasingly common consequence of falls in older people that are associated with a high risk of death and reduced function. The vast majority of intertrochanteric fractures require surgical treatment to withstand early mobilization and weight bearing, which prevents complications due to prolonged bed rest and aids in fracture healing.

METHODS: This study is compromised by two parts, the experimental study and the clinical part. In the first part, a standard 130° nail will be used with the appropriate lag screw(s) and dynamic distal locking in synthetic osteoporotic femurs and the transmission of forces in the proximal femur, measured by a cortical surface-strain distribution, will be evaluated using digital image correlation. Finite element parametric models of the bone, the nails and their interface will be also developed. Finite element computations of surface strains in implanted femurs, after being validated against biomechanical testing measurements, will be used to assist the comparison of the nails by deriving important data on the developed stress and strain fields, which cannot be measured through biomechanical testing. In the other part, will set up a prospective, randomized, comparative clinical study among the Gamma3 and IT cephalomedullary nailing, in order to investigate if there are any statistical important differences in the main radiological measurements and functional status in closed unstable intertrochanteric fractures (A21-3) in patients aged over 70 years old at the 24-week follow-up evaluation using patient reported disease-specific outcomes.

DISCUSSION: This study will be the first to compare clinical, radiological and biomechanical measurements of the two different cephalomedullary nails. Our main hypothesis is that the IT nail would provide better radiological outcome and probably better clinical results than the Gama3 nail. Clinical trial registration International Standard Randomized Controlled Trial Number (ISRCTN): https://doi.org/10.1186/ISRCTN15588442 , registered on 19/4/2022.

PMID:37507795 | DOI:10.1186/s13018-023-04009-8