Tag: statistics

JAMA Netw Open. 2022 Nov 1;5(11):e2243201. doi: 10.1001/jamanetworkopen.2022.43201.

ABSTRACT

IMPORTANCE: In the Cardiovascular Outcomes for People Using Anticoagulation Strategies (COMPASS) trial, there was a significant reduction in the adjudicated primary outcome among patients with stable atherosclerotic vascular disease randomized to dual pathway inhibition (rivaroxaban 2.5 mg twice daily plus aspirin 100 mg daily) vs aspirin monotherapy, but not with rivaroxaban 5 mg twice daily vs aspirin monotherapy. Whether the results are similar without adjudication is unknown.

OBJECTIVE: To examine the impact of dual pathway inhibition (with rivaroxaban plus aspirin) or rivaroxaban monotherapy compared with aspirin monotherapy on investigator-reported CV events and to understand the extent of concordance between investigator-reported and centrally adjudicated clinical events.

DESIGN, SETTING, AND PARTICIPANTS: This is a secondary analysis of the COMPASS trial, an international, double-blind, double-dummy, randomized clinical trial with a 3-by-2 partial factorial design that evaluated participants with stable atherosclerotic vascular disease receiving rivaroxaban plus aspirin, rivaroxaban monotherapy, or aspirin monotherapy. End points were collected by blinded site investigators and adjudicated by a blinded clinical end point committee. Data were analyzed from March 2013 through February 2017.

INTERVENTIONS: Participants received dual inhibition pathway (2.5 mg rivaroxaban twice daily plus 100 mg aspirin once daily), rivaroxaban monotherapy (5 mg twice daily), or aspirin monotherapy (100 mg once daily).

MAIN OUTCOMES AND MEASURES: The primary efficacy outcome was a composite of cardiovascular (CV) death, stroke, or myocardial infarction (MI). Adjudicated and investigator-reported end points were compared.

RESULTS: A total of 27 395 patients (mean [SD] age, 68.2 [7.9] years; 78.0% men) were assessed, including 9152 patients randomized to dual pathway inhibition, 9117 patients randomized to rivaroxaban monotherapy, and 9126 patients randomized to aspirin monotherapy. Adjudication reduced the number of events by 10% to 15% for most end points. Among investigator-reported end points, dual pathway inhibition significantly reduced the rate of the primary efficacy outcome compared with aspirin alone (411 patients [4.5%] vs 542 patients [5.9%]; hazard ratio [HR], 0.75 [95% CI, 0.66-0.85]; P < .001), with similar reduction in adjudicated end points, (379 patients [4.1%] vs 496 patients [5.4%]; HR, 0.76 [95% CI, 0.66-0.86]; P < .001). Likewise, effects on ischemic end points were highly concordant (κ statistic = 0.94 [95% CI, 0.93-0.95] for the primary composite end point). Unlike with adjudicated outcomes, there was a significant reduction in the primary end point with rivaroxaban monotherapy vs aspirin monotherapy using investigator-reported events (477 patients [5.2%] vs 542 patients [5.9%]; HR, 0.88 [95% CI, 0.78-0.99]; P = .04) compared with adjudicated events (448 patients [4.9%] vs 496 patients [5.4%]; HR, 0.90 [95% CI, 0.79-1.03]; P = .12).

CONCLUSIONS AND RELEVANCE: This secondary analysis of the COMPASS trial found that whether assessed by blinded site investigators or adjudicators, dual pathway inhibition significantly reduced CV events among patients with stable atherosclerotic disease compared with aspirin plus placebo. These findings suggest that using investigator-reported events in blinded clinical trials may be a more efficient alternative to adjudication.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01776424.

PMID:36409491 | DOI:10.1001/jamanetworkopen.2022.43201

Diabetes Technol Ther. 2022 Nov 21. doi: 10.1089/dia.2022.0419. Online ahead of print.

ABSTRACT

BACKGROUND: The majority of individuals referred to diabetes self-management education and support (DSMES) programs do not access this resource. Of those who do, attrition is high, with anecdotal reports pointing to the didactic and impersonal nature of these programs contributing to low utilization and completion rates. In an effort to develop a more engaging form of DSMES for adults with type 2 diabetes (T2D), we constructed a non-didactic, “discovery learning”-based DSMES program centered on real-time flash glucose monitoring (FGM).

METHODS: In this single-arm pilot study, 35 adults with T2D duration 1 – 5 years, ages 21 – 75 years, not using insulin and HbA1c >8.0% were introduced to FGM and participated in five weekly group sessions. DSMES content was personalized, emerging from the concerns and questions arising from participants’ FGM discoveries. The primary outcome was glycemic change as assessed by blinded FGM at baseline and month 3. Secondary outcomes included psychosocial and behavioral measures.

RESULTS: There was a significant gain in % TIR 70 -180 mg/dL from baseline (55%) to month 3 (74%), and a parallel drop in TAR > 180 mg/dL from 44% to 25% (ps = 0.01). Overall well-being rose significantly (p = 0.04), while diabetes distress showed a non-significant drop. Participants reported improvements in healthy eating (p < 0.001) and physical activity, though the latter did not reach statistical significance.

CONCLUSIONS: These findings support a new approach to DSMES, a method that integrates FGM with a highly interactive and engaging, patient-driven, “discovery learning” approach to education.

PMID:36409486 | DOI:10.1089/dia.2022.0419

JAMA Intern Med. 2022 Nov 21. doi: 10.1001/jamainternmed.2022.5268. Online ahead of print.

NO ABSTRACT

PMID:36409473 | DOI:10.1001/jamainternmed.2022.5268

CJEM. 2022 Nov 21. doi: 10.1007/s43678-022-00411-z. Online ahead of print.

NO ABSTRACT

PMID:36409448 | DOI:10.1007/s43678-022-00411-z

Environ Sci Pollut Res Int. 2022 Nov 21. doi: 10.1007/s11356-022-24113-2. Online ahead of print.

ABSTRACT

The purpose of this paper is to quantify the level of new-type urbanization and unravel the spatial and nonlinear effects of new-type urbanization and technological innovation on industrial carbon emissions. Although the impact of traditional urbanization levels on carbon emissions has been widely studied, there is still a huge room for optimization, and the impact of new-type urbanization on carbon emissions has not yet been clarified. Selecting 37 cities in the Yangtze River Delta as a research sample, this paper measures the new-type urbanization based on an evaluation system we build. Consequently, we assess the spatial and nonlinear effects of new-type urbanization and technological innovation on carbon emissions by the spatial Durbin model and non-parameter addictive model, respectively. The results indicate that the new-type urbanization and low-carbon city pilot policy have significant spatial spillover effects on reducing carbon dioxide emissions, while the economic growth plays a positive role in increasing carbon emission. As for nonlinear effects, there is a significant inverted “N”-shaped relationship between the level of new-type urbanization and carbon dioxide emissions, while the nexus between technological innovation and carbon emissions is an inverted “U”-shaped relationship. This paper provides a new perspective for confirming the mechanism of the new-type urbanization on carbon emissions. Meanwhile, these findings are of significance for the relevant authorities in China to develop appropriate policy in carbon dioxide emission reduction.

PMID:36409416 | DOI:10.1007/s11356-022-24113-2

Environ Sci Pollut Res Int. 2022 Nov 21. doi: 10.1007/s11356-022-24222-y. Online ahead of print.

ABSTRACT

Recently, a growing number of epidemiological studies have examined the relationship between household air pollution (HAP) and all-cause and cause-specific mortality. While the results were not entirely consistent, the current study followed the Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) protocol to conduct a comprehensive review and meta-analysis. Data sources were PubMed, Web of Science, Embase, and Cochrane Library for studies published up to 12 May 2022. The pooled relative risks (RRs) with 95% confidence intervals (CI) were used to estimate the effect of household air pollution on all-cause and cause-special mortality. Then I square value (I²) was used to assess heterogeneity, and random-effects model was used as the pooling method. Seventeen studies were included in the quantitative analysis. Our results showed a significant association between household air pollution and increased risks of all-cause mortality (RR = 1.12, 95% CI = 1.06-1.19) and cardiovascular disease mortality (RR = 1.13, 95% CI = 1.04-1.24). Similarly, the associations between household air pollution and mortality from other specific causes (respiratory, ischemic heart disease, stroke, and total cancer) were positive, although they were not statistically significant. The study suggests that exposure to household air pollution increases the risk of all-cause mortality and cardiovascular disease mortality. In addition, our results found a trend of increased mortality from the respiratory system, ischemic heart disease, stroke, and total cancer, with household air pollution.

PMID:36409413 | DOI:10.1007/s11356-022-24222-y

Mol Biol Rep. 2022 Nov 21. doi: 10.1007/s11033-022-08104-7. Online ahead of print.

ABSTRACT

BACKGROUND: Diffuse large B-cell lymphoma (DLBCL) is the most common subtype of non-Hodgkin’s lymphoma, which can involve various types of mature B-cells. Considering that the incidence of DLBCL has increased, additional research is required to identify novel and effective prognostic and therapeutic molecules. Fc receptor-like 1 (FCRL1) acts as an activation co-receptor of human B-cells. Aberrant expression of this molecule has been reported in a number of B-cell-related disorders. Moreover, the clinical significance and prognosis value of FCRL1 in DLBCL are not completely identified.

METHODS: In this study, the expression levels of FCRL1 were determined in thirty patients with DLBCL and 15 healthy controls (HCs). In addition, the correlation between FCRL1 expressions with clinicopathological variables of DLBCL patients were examined. Then, the potential roles of FCRL1 in proliferation, apoptosis, and cell cycle distribution of B-cells from DLBCL patients were determined using flow cytometry analysis, after knockdown of this marker using retroviral short hairpin RNA interference. Quantitative real time-PCR, western blotting, and enzyme-linked immunosorbent assay were also used to identify the possible effects of FCRL1 knockdown on the expression levels of BCL-2, BID, BAX, intracellular signaling pathway PI3K/p-Akt, and p65 nuclear factor-kappa B (NF-κB) in the B-cells of DLBCL.

RESULTS: Statistical analysis revealed higher levels of FCRL1 expression in the B-cells of DLBCL patients compared to HCs at both protein and mRNA levels. A positive correlation was observed between the FCRL1 expression and some clinicopathological parameters of DLBCL patients. In addition, FCRL1 knockdown significantly decreased cell proliferation and stimulated apoptosis as well as G1 cell cycle arrest in the B-cells of DLBCL patients. The levels of p65 NF-κB and PI3K/p-Akt expressions were markedly reduced after knockdown of FCRL1 expression.

CONCLUSIONS: These results suggested that FCRL1 could be a potential novel biomarker for prognosis and/or a possible effective therapeutic target for treatment of patients with DLBCL.

PMID:36409389 | DOI:10.1007/s11033-022-08104-7

World J Microbiol Biotechnol. 2022 Nov 21;39(1):20. doi: 10.1007/s11274-022-03461-8.

ABSTRACT

Smokeless tobacco (ST) consumption keeps human oral health at high risk which is one of the major reasons for oral tumorigenesis. The chemical constituents of the ST products have been well discussed; however, the inhabitant microbial diversity of the ST products is less explored especially from south Asian regions. Therefore, the present investigation discusses the bacteriome-based analysis of indigenous tobacco products. The study relies on 16S amplicon-based bacteriome analysis of Indian smokeless tobacco (ST) products using a metagenomic approach. A total of 59,15,143 high-quality reads were assigned to 34 phyla, 82 classes, 176 orders, 256 families, 356 genera, and 154 species using the SILVA database. Of the phyla (> 1%), Firmicutes dominate among the Indian smokeless tobacco followed by Proteobacteria, Bacteroidetes, and Actinobacteria (> 1%). Whereas, at the genera level (> 1%), Lysinibacillus, Dickeya, Terribacillus, and Bacillus dominate. The comparative analysis between the loose tobacco (LT) and commercial tobacco (CT) groups showed no significant difference at the phyla level, however, only three genera (Bacillus, Aerococcus, and Halomonas) were identified as significantly different between the groups. It indicates that CT and LT tobacco share similar bacterial diversity and poses equal health risks to human oral health. The phylogenetic investigation of communities by reconstruction of unobserved states (PICRUSt 2.0) based analysis uncovered several genes involved in nitrate/nitrite reduction, biofilm formation, and pro-inflammation that find roles in oral pathogenesis including oral cancer. The strong correlation analysis of these genes with several pathogenic bacteria suggests that tobacco products pose a high bacterial-derived risk to human health. The study paves the way to understand the bacterial diversity of Indian smokeless tobacco products and their putative functions with respect to human oral health. The study grabs attention to the bacterial diversity of the smokeless tobacco products from a country where tobacco consumers are rampantly prevalent however oral health is of least concern.

PMID:36409379 | DOI:10.1007/s11274-022-03461-8

Pediatr Nephrol. 2022 Nov 21. doi: 10.1007/s00467-022-05807-8. Online ahead of print.

ABSTRACT

BACKGROUND: There is a paucity of literature on the normative levels of plasma renin concentration (PRC) and serum aldosterone (SA) in premature neonates. This study aims to provide normative data on PRC and SA levels in preterm neonates in the first 2 weeks after birth and explore associations with maternal, perinatal, or postnatal factors.

METHODS: Neonates born at 26- to 34-week gestation were recruited from two neonatal intensive care units in Canada and Australia. The direct renin assay PRC and SA were analyzed on day 1 and days 14-21 after birth to compare across categorical variables and to produce normative values.

RESULTS: A total of 262 subjects were enrolled from the Canadian (29%) and Australian (71%) sites. The mean gestational age was 30 weeks, with a mean birth weight of 1457 g. The normative values of PRC and SA for neonates born between 26 + 0 and 29 + 6 weeks and 30 + 0 and 34 + 0 weeks of gestation were produced for day 1 and day 14-21 after birth. Both PRC and SA increased from day 1 to day 14-21. The more premature neonates reached a higher PRC on days 14-21 after birth but exhibited lower SA levels on day 1 after birth. When comparing gender, birth weight, and maternal risk factor categories, no statistical differences in PRC or SA were found. A small but significant decrease in PRC, but not SA, was noted for neonates with placental pathology.

CONCLUSIONS: This study produced normative values of PRA and SA in clinically stable preterm neonates that can be referenced for use in clinical practice. A higher resolution version of the Graphical abstract is available as Supplementary information.

PMID:36409371 | DOI:10.1007/s00467-022-05807-8

Clin Oral Investig. 2022 Nov 21. doi: 10.1007/s00784-022-04792-4. Online ahead of print.

ABSTRACT

OBJECTIVES: The aim of this study was to evaluate the effectiveness of ultrasonic activation (US) over glycolic acid on microhardness, cohesive strength, flexural strength, and fracture resistance of root dentin, comparing with conventional final irrigation protocols.

METHODS: Samples were obtained from 140 extracted bovine teeth and distributed into four test groups: microhardness (50 teeth), cohesive strength (15 teeth), flexural strength (15 teeth), and fracture resistance (60 teeth). In all four tests, specimens were subdivided into five groups, according to final irrigation protocols: G1: distilled water (DW); G2: 17% ethylenediaminetetraacetic acid (EDTA); G3: 17% glycolic acid (GA); G4: 17% EDTA + US; and G5: 17% GA + US. The duration time of each protocol was set in 1 min. After irrigation protocols, the Vickers tester was used to evaluate microhardness and the universal testing machine was used to evaluate the cohesive strength, flexural strength, and fracture resistance of the root dentin. One-way ANOVA test and the Tukey HSD were used for multiple comparison tests in all evaluations (α = 5%).

RESULTS: In general, groups 2 (EDTA), 4 (EDTA + US), and 5 (GA + US) promoted the highest reduction of microhardness, being statistically different from other groups (p < 0.05). Cohesive strength, flexural strength, and fracture resistance data revealed that no differences between groups were observed (p > 0.05).

CONCLUSIONS: The association of GA and US results in microhardness reduction, with no influence on cohesive strength, flexural strength, and fracture resistance of the root dentin.

CLINICAL RELEVANCE: The use of US over GA has no influence on some mechanical properties of root dentin.

PMID:36409357 | DOI:10.1007/s00784-022-04792-4