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Nevin Manimala Statistics

Prognostic Implications of Skin Invasion in Locally Advanced Oral Cavity Squamous Cell Carcinoma

Otolaryngol Head Neck Surg. 2022 Aug 2:1945998221116746. doi: 10.1177/01945998221116746. Online ahead of print.

ABSTRACT

OBJECTIVE: To evaluate the effect of histopathologic skin invasion on 2- and 5-year disease-free survival (DFS) and overall survival (OS) in patients treated with primary surgery for locally advanced oral cavity squamous cell carcinoma (OCSCC).

STUDY DESIGN: A retrospective case-control study was performed comparing previously untreated patients with pT4a OCSCC with and without skin invasion.

SETTING: Academic medical center.

METHODS: Propensity score-matched cohorts were derived by age, sex, surgical margins, pathologic N classification, adjuvant treatment, and primary tumor site. The Kaplan-Meier method was used to evaluate 2- and 5-year OS and DFS, which were compared between cohorts via the log rank (Mantel-Cox) test statistic.

RESULTS: Overall 25 patients were identified to have pathologic skin invasion, and 50 were selected for the matched control group. OS was significantly lower for patients with skin invasion as compared with controls at 2 years (30.8% vs 53.3%, P = .018) and 5 years (16.6% vs 42.2%, P = .01). DFS was significantly lower for patients with skin invasion vs controls at 2 years (23.7% vs 47.7, P = .037) and 5 years (15.8% vs 41.4%, P = .024).

CONCLUSION: Histopathologic skin invasion in OCSCC is associated with dismal prognosis in patients who underwent primary surgical treatment. OS outcomes for patients with skin invasion are comparable to survival of patients with recurrent/metastatic disease and T4N2 disease.

PMID:35917167 | DOI:10.1177/01945998221116746

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Nevin Manimala Statistics

Namco: a microbiome explorer

Microb Genom. 2022 Aug;8(8). doi: 10.1099/mgen.0.000852.

ABSTRACT

16S rRNA gene profiling is currently the most widely used technique in microbiome research and allows the study of microbial diversity, taxonomic profiling, phylogenetics, functional and network analysis. While a plethora of tools have been developed for the analysis of 16S rRNA gene data, only a few platforms offer a user-friendly interface and none comprehensively covers the whole analysis pipeline from raw data processing down to complex analysis. We introduce Namco, an R shiny application that offers a streamlined interface and serves as a one-stop solution for microbiome analysis. We demonstrate Namco’s capabilities by studying the association between a rich fibre diet and the gut microbiota composition. Namco helped to prove the hypothesis that butyrate-producing bacteria are prompted by fibre-enriched intervention. Namco provides a broad range of features from raw data processing and basic statistics down to machine learning and network analysis, thus covering complex data analysis tasks that are not comprehensively covered elsewhere. Namco is freely available at https://exbio.wzw.tum.de/namco/.

PMID:35917163 | DOI:10.1099/mgen.0.000852

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Nevin Manimala Statistics

Incidence of Acute Chest Syndrome in Children With Sickle Cell Disease Following Implementation of the 13-Valent Pneumococcal Conjugate Vaccine in France

JAMA Netw Open. 2022 Aug 1;5(8):e2225141. doi: 10.1001/jamanetworkopen.2022.25141.

ABSTRACT

IMPORTANCE: Acute chest syndrome (ACS) is one of the leading acute severe complications of sickle-cell disease (SCD). Although Streptococcus pneumoniae (S pneumoniae) is highly prevalent in children with SCD, its precise role in ACS is unclear. The efficacy of 13-valent pneumococcal conjugate vaccine (PCV13) implementation on ACS is still unknown.

OBJECTIVE: To assess the association of PCV13 implementation in the general pediatric population with the incidence of ACS in children with SCD.

DESIGN, SETTING, AND PARTICIPANTS: This cohort study used an interrupted time-series analysis of patient records from a national hospital-based French surveillance system. All children younger than 18 years with SCD (based on the International Statistical Classification of Diseases and Related Health Problems, Tenth Revision definition) hospitalized in France between January 2007 and December 2019 were included.

EXPOSURES: PCV13 implementation.

MAIN OUTCOMES AND MEASURES: Monthly incidence of ACS per 1000 children with SCD over time as analyzed by segmented linear regression with autoregressive error; monthly incidence of hospitalization for vaso-occlusive crisis, asthma crisis, and acute pyelonephritis per 1000 children with SCD over the same period as the control outcomes.

RESULTS: Among the 107 694 hospitalizations of children with SCD, 4007 episodes of ACS were included (median [IQR] age, 8 [4-12] years; 2228 [55.6%] boys). PCV13 implementation in 2010 was followed by a significant decrease in the incidence of ACS (-0.9% per month; 95% CI, -1.4% to -0.4%; P < .001), with an estimated cumulative change of -41.8% (95% CI, -70.8% to -12.7%) by 2019. Sensitivity analyses yielded the same results, including the incidence of ACS adjusted for that of vaso-occlusive crisis over time. The results were similar among different age groups. By contrast, no change was found for the 3 control outcomes over the study period.

CONCLUSIONS AND RELEVANCE: PCV13 implementation was associated with an important reduction in the incidence of ACS in children with SCD. This vaccine benefit provides new evidence of the key role of S pneumoniae in ACS and should be considered when estimating outcomes associated with current PCVs and the potential benefit of next-generation PCVs in children.

PMID:35917121 | DOI:10.1001/jamanetworkopen.2022.25141

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Nevin Manimala Statistics

Outcomes in Pediatric Hip FAI Surgery: a Scoping Review

Curr Rev Musculoskelet Med. 2022 Aug 2. doi: 10.1007/s12178-022-09771-6. Online ahead of print.

ABSTRACT

PURPOSE OF REVIEW: Femoracetabular impingement (FAI) is a common source of hip pain in children and adolescents. While nonoperative therapies and open surgical procedures can be effective, hip arthroscopy is a minimally invasive treatment option with substantial benefit. The purpose of this paper is to evaluate the current role of hip arthroscopy in treating FAI within the pediatric population. This article examines its efficacy through a review of hip arthroscopy outcomes in the contemporary orthopaedic literature.

RECENT FINDINGS: Morphologic changes in the acetabulum and proximal femur seen in FAI can be attributed to a multitude of etiologies-including idiopathic FAI, Legg-Calve-Perthes, and slipped capital femoral epiphysis. In general, arthroscopic treatment of FAI secondary to these conditions leads to statistically significant improvements in pain and patient-reported outcomes in the short and long term. In the pediatric athlete, repetitive stress on the hip perpetuates FAI and can drastically hinder performance. Hip arthroscopy allows for a high rate of return to sport with minimal morbidity in this population. Overall, pediatric hip arthroscopy is effective in treating FAI secondary to a wide variety of conditions. Despite its clinical benefits, patients and their families should be counseled regarding alternative treatments, potential complications, and return to play.

PMID:35917094 | DOI:10.1007/s12178-022-09771-6

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Earned Income Tax Credit and Youth Violence: Findings from the Youth Risk Behavior Surveillance System

Prev Sci. 2022 Aug 2. doi: 10.1007/s11121-022-01417-w. Online ahead of print.

ABSTRACT

Family- and neighborhood-level poverty are associated with youth violence. Economic policies may address this risk factor by reducing parental stress and increasing opportunities. The federal Earned Income Tax Credit (EITC) is the largest cash transfer program in the US providing support to low-income working families. Many states have additional EITCs that vary in structure and generosity. To estimate the association between state EITC and youth violence, we conducted a repeated cross-sectional analysis using the variation in state EITC generosity over time by state and self-reported data in the Youth Risk Behavior Surveillance System (YRBSS) from 2005 to 2019. We estimated the association for all youth and then stratified by sex and race and ethnicity. A 10-percentage point greater state EITC was significantly associated with 3.8% lower prevalence of physical fighting among youth, overall (PR: 0.96; 95% CI 0.94-0.99), and for male students, 149 fewer (95% CI: -243, -55) students per 10,000 experiencing physical fighting. A 10-percentage point greater state EITC was significantly associated with 118 fewer (95% CI: -184, -52) White students per 10,000 experiencing physical fighting in the past 12 months while reductions among Black students (75 fewer; 95% CI: -176, 26) and Hispanic/Latino students (14 fewer; 95% CI: -93, 65) were not statistically significant. State EITC generosity was not significantly associated with measures of violence at school. Economic policies that increase financial security and provide financial resources may reduce the burden of youth violence; further attention to their differential benefits among specific population subgroups is warranted.

PMID:35917082 | DOI:10.1007/s11121-022-01417-w

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Nevin Manimala Statistics

Association of urinary or blood heavy metals and mortality from all causes, cardiovascular disease, and cancer in the general population: a systematic review and meta-analysis of cohort studies

Environ Sci Pollut Res Int. 2022 Aug 2. doi: 10.1007/s11356-022-22353-w. Online ahead of print.

ABSTRACT

Amounting epidemiological evidence has shown detrimental effects of heavy metals on a wide range of diseases. However, the effect of heavy metal exposure on mortality in the general population remains unclear. The primary objective of this study was to clarify the associations between heavy metals and mortality from all causes, cardiovascular disease (CVD), and cancer based on prospective studies. We comprehensively searched Pubmed, Embase, and Web of Science electronic databases to identify studies published from their inception until 1 March 2022. Investigators identified inclusion criteria, extracted study characteristics, and assessed the methodological quality of included studies according to standardized guidelines. Meta-analysis was conducted if the effect estimates of the same outcome were reported in at least three studies. Finally, 42 original studies were identified. The results of meta-analysis showed that cadmium and lead exposure was significantly associated with mortality from all causes, CVD, and cancer in the general population. Moderate evidence suggested there was a link between arsenic exposure and mortality. The adverse effects of mercury and other heavy metals on mortality were inconclusive. Epidemiological evidence for the joint effect of heavy metal exposure on mortality was still indeterminate. In summary, our study provided compelling evidence that exposure to cadmium, lead, and arsenic were associated with mortality from all causes, CVD, and cancer, while the evidence on other heavy metals, for example mercury, was insignificant or indeterminate. Nevertheless, further prospective studies are warranted to explore the joint effects of multiple metal exposure on mortality.

PMID:35917074 | DOI:10.1007/s11356-022-22353-w

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Nevin Manimala Statistics

Racial/Ethnic Differences in Psychometric Properties of Alcohol-Related Behaviors in the USA

J Racial Ethn Health Disparities. 2022 Aug 2. doi: 10.1007/s40615-022-01379-3. Online ahead of print.

ABSTRACT

OBJECTIVE: Alcohol-related behaviors are often examined using surveys assessing participants’ self-report of attitudes/actions. However, racial/ethnic differences exist in scale construction and evaluation, and surveys evaluating alcohol behaviors lack invariance across ethnic groups. These dissimilarities may be due to deep-rooted differences in ethnic classification of unhealthy substance use behaviors.

METHODS: We examined factor structure of “Number of days per month drank alcohol in past 12 months,” “Number of days had one or more drinks in past 30 days,” and “Number of days had four/five or more drinks in past 30 days,” administered during the 2017 National Survey on Drug Use and Health. Factorial invariance was examined across 12- to 17-year-old White, Black/African American, Asian American, and Hispanic/Latinx boys and girls endorsing alcohol use. A multigroup confirmatory factor analysis statistically determined whether the factor structure was invariant across groups.

RESULTS: The alcohol scale lacked invariance across all groups, indicating racial/ethnic group identification is related to alcohol-related cognitions.

CONCLUSIONS: Psychometric properties of scales assessing alcohol-related behaviors generalized across racial/ethnic groups require evaluation.

PMID:35917062 | DOI:10.1007/s40615-022-01379-3

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Nevin Manimala Statistics

Adjusting Overall Survival Estimates of Macitentan in Pulmonary Arterial Hypertension After Treatment Switching: Results from the SERAPHIN Study

Adv Ther. 2022 Aug 1. doi: 10.1007/s12325-022-02253-8. Online ahead of print.

ABSTRACT

INTRODUCTION: Evaluating overall survival in randomized controlled trials (RCTs) can often be confounded by bias introduced by treatment switching. SERAPHIN was a large RCT that evaluated the effects of long-term treatment with the endothelin receptor antagonist macitentan in patients with pulmonary arterial hypertension. In an intent-to-treat (ITT) analysis, a non-significant decrease in the risk of all-cause mortality up to study closure was reported with macitentan 10 mg versus placebo. As patients could switch treatment when experiencing symptoms of disease progression, this analysis attempts to adjust for the confounding effects on overall survival.

METHODS: The inverse probability of censoring weighted (IPCW) and rank-preserving structural failure time (RPSFT) models were used to estimate the treatment effect on overall mortality had there been no treatment switching in SERAPHIN. Time to all-cause death was evaluated up to study closure. Treatment switching was defined as patients in the placebo group switching to open-label macitentan 10 mg, and patients in the macitentan 10 mg group prematurely discontinuing macitentan.

RESULTS: By study closure, 73.2% (183/250) of patients in the placebo group had switched to macitentan 10 mg. Among these patients, exposure time to macitentan 10 mg represented 28.2% of total study treatment exposure (cumulative exposure 134.6 patient-years). At study closure, 24.8% (60/242) of patients in the macitentan 10 mg group were not receiving open-label macitentan; mean time not receiving macitentan was 44.3 weeks. The adjusted hazard ratios (HR) for overall survival using the IPCW and RPSFT methods were lower (HR 0.42, 95% confidence interval [CI] 0.22, 0.81; p = 0.009, and HR 0.33, 95% CI 0.04, 2.83, respectively) than the ITT unadjusted HR (0.80, 95% CI 0.51, 1.24).

CONCLUSION: These results from the current analyses indicate that in SERAPHIN, the standard ITT analysis was confounded by treatment switching resulting in an underestimation of the benefit of macitentan 10 mg on overall survival. By adjusting for switching, the IPCW and RPSFT models estimated a 58% and 67% reduction in risk of mortality, respectively, with macitentan 10 mg versus placebo.

TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT00660179.

PMID:35917059 | DOI:10.1007/s12325-022-02253-8

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Nevin Manimala Statistics

The impact of continuous wireless monitoring on adverse device effects in medical and surgical wards: a review of current evidence

J Clin Monit Comput. 2022 Aug 2. doi: 10.1007/s10877-022-00899-x. Online ahead of print.

ABSTRACT

Novel technologies allow continuous wireless monitoring systems (CWMS) to measure vital signs and these systems might be favorable compared to intermittent monitoring regarding improving outcomes. However, device safety needs to be validated because uncertain evidence challenges the clinical implementation of CWMS. This review investigates the frequency of device-related adverse events in patients monitored with CWMS in general hospital wards. Systematic literature searches were conducted in PubMed and Embase. We included trials of adult patients in general hospital wards monitored with CWMS. Our primary outcome was the frequency of unanticipated serious adverse device effects (USADEs). Secondary outcomes were adverse device effects (ADEs) and serious adverse device effects (SADE). Data were extracted from eligible studies and descriptive statistics were applied to analyze the data. Seven studies were eligible for inclusion with a total of 1485 patients monitored by CWMS. Of these patients, 54 patients experienced ADEs (3.6%, 95% CI 2.8-4.7%) and no USADEs or SADEs were reported (0%, 95% CI 0-0.31%). The studies of the SensiumVitals® patch, the iThermonitor, and the ViSi Mobile® device reported 28 (9%), 25 (5%), and 1 (3%) ADEs, respectively. No ADEs were reported using the HealthPatch, WARD 24/7 system, or Coviden Alarm Management. Current evidence suggests that CWMS are safe to use but systematic reporting of all adverse device effects is warranted.

PMID:35917046 | DOI:10.1007/s10877-022-00899-x

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Nevin Manimala Statistics

Developing and Validating Risk Algorithm for Hypertension in South Africa: Results from a Nationally Representative Cohort (2008-2017)

High Blood Press Cardiovasc Prev. 2022 Aug 2. doi: 10.1007/s40292-022-00534-5. Online ahead of print.

ABSTRACT

INTRODUCTION: There is compelling evidence of significant country-level disparities where African countries, particularly South Africa, have the highest hypertension rates in the world.

AIM: To develop and validate a simple risk scoring algorithm for hypertension in a large cohort (80,270) of South African men and women.

METHODS: Multivariable logistic regression models were used to build our hypertension risk scoring algorithm and validated externally and internally using the standard statistical techniques. We also compared our risk scores with the results from the Framingham risk prediction model for hypertension.

RESULTS: Six factors were identified as the significant correlates of hypertension: age, education, obesity, smoking, alcohol intake and exercise. A score of ≥ 25 (out of 57) for men and ≥ 35 (out of 75) for women were selected as the optimum cut-points with 82% (43%) and 83% (49%) sensitivity (specificity) for males and females, respectively in the development datasets. We estimated probabilities of developing hypertension using the Framingham risk prediction model, which were higher among those with higher scores for hypertension.

CONCLUSIONS: Identifying, targeting and prioritising individuals at highest risk of hypertension will have significant impact on preventing severe cardiometabolic diseases by scaling up healthy diet and life-style factors. Our six-item risk scoring algorithm may be included as part of hypertension prevention and treatment programs by targeting older individuals with high body fat measurements who are at highest risk of developing hypertension.

PMID:35917033 | DOI:10.1007/s40292-022-00534-5