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Nevin Manimala Statistics

The effect of fiber insertion on fracture strength and fracture modes in endocrown and overlay restorations

Microsc Res Tech. 2021 Dec 29. doi: 10.1002/jemt.24040. Online ahead of print.

ABSTRACT

Aim of this study was to determine the fracture strength and modes of endocrown and overlay restorations with/without fiber reinforcement on endodontically treated teeth. Sixty-five molar teeth were used: Group IN (intact teeth), Group E (endocrown), Group ER (endocrown + ribbond), Group O (overlay), Group OR (overlay + ribbond; n = 13). Ribbond (Seattle, WA) was inserted at the base of pulp chamber in Group ER and OR. All restorations were designed and produced by using computer-aided design and computer-aided manufacturing (Sirona Dental Systems, Bensheim, Germany) and Cerasmart (GC Corp. Kasugai, Aichi, Japan). All teeth were subjected to thermomechanical aging and fractured in a universal test device. Fractured surfaces were analyzed with a stereomicroscope (SMZ1000, Nikon, Japan). Data were analyzed with Welch’s analysis of variance and Games-Howell test (p < .001). Group E showed significantly lower fracture strength values than other groups(p < .05). No statistically significant differences were found among the other groups(p > .05). Most of the unfavorable fractures were seen in Groups E and O. Overlay restorations showed higher fracture strength values than endocrown restorations. Although fiber insertion did not improve the fracture strength of the indirect restorations, it reduced the frequency of irreparable fracture mode. Overlay restorations and fiber application are more advantageous in preserving the durability of the endodontically treated teeth.

PMID:34964540 | DOI:10.1002/jemt.24040

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Nevin Manimala Statistics

Home-based unsupervised pulmonary rehabilitation program improves the respiratory disability in systemic sclerosis patients with dyspnea: an observational prospective study

Monaldi Arch Chest Dis. 2021 Dec 28. doi: 10.4081/monaldi.2021.1984. Online ahead of print.

ABSTRACT

Dyspnea is a common symptom in Systemic Sclerosis (SSc) that considerably decreases patients’ quality of life (QoL). Pulmonary Rehabilitation (PR) mitigates dyspnea impact on daily activities. The aim of this study is to evaluate the effect on respiratory disability of home-based PR in SSc patients with dyspnea. In this observational prospective monocentric study, we screened all dyspneic SSc consecutive patients attending the Rheumatological day hospital in the University hospital of Parma from January 2019 and June 2019. The aim of our study was to understand if a PR unsupervised home-based program could improve respiratory disability in this specific population. Dyspnea was evaluated with the self-administered questionnaires modified Medical Research Council (mMRC) and Saint George’s Respiratory Questionnaire (SGRQ).Patients also filled in Short Form 36 (SF36) and the Modified-Health Assessment Questionnaire for SSc (HAQ-MOD). Health Professionals assessed and trained the patients and collected data before PR and at the end of the program. PR consisted in 5 weekly unsupervised sessions for 8 weeks. Wilcoxon test for paired data evaluated the changes after PR. p<0.05 was considered statistically significant. 46 SSc patients were included (43 female). Only 31 (29 female) performed PR as planned (Adherent Group-AG) while the others gave up within the first week (Non-Adherent Group-NAG). All SGRQ domains (Symptoms: from 30 to 18; p=0.0055; Activity: from 47 to 35, p=0.23; Impact from 29 to 25, p=0.044) and SGRQ total score (from 35 to 29; p=0.022) improved in AG. SGRQ scores did not change in NAG as well as SF36 and HAQ-MOD in both groups. The home-based PR program dramatically decreased the effect, frequency and severity of respiratory symptoms. Conversely, it slightly changed the activities causing breathlessness and dyspnea-related social functioning disturbances. PR appears to be a useful tool in treatment strategies aiming to achieve a QoL improvement in SSc patients.

PMID:34964573 | DOI:10.4081/monaldi.2021.1984

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Nevin Manimala Statistics

Multiplex proteomics as risk predictor of infection in patients treated with hemodialysis-A prospective multicenter study

Hemodial Int. 2021 Dec 29. doi: 10.1111/hdi.12987. Online ahead of print.

ABSTRACT

INTRODUCTION: Severe infection is a major problem in hemodialysis patients. Multiplex proteomics might reveal novel insights into disease mechanisms increasing the risk of infection and might also be used as a risk prediction tool. The aims of this study were (1) to evaluate associations between 92 proteins assessed by a proximity extension assay and the development of severe infection in patients on hemodialysis and (2) to develop a risk prediction model for severe infection using prespecified clinical variables and proteomics.

METHODS: Prospective, observational multicenter cohort study with 5-year follow-up. Patients receiving in-center hemodialysis in five facilities in Denmark were included. The primary composite endpoint was death caused by infection, bacteremia, and infections requiring hospitalization of at least 2 days or prolonging a hospital stay.

FINDINGS: Of 331 patients included 210 patients reached the primary endpoint during follow-up. In adjusted Cox regression analyses, 14 plasma proteins were associated with severe infection. Correcting for multiple testing revealed only cathepsin-L1 and interleukin-6 significantly associated with the primary outcome. Cathepsin-L1-hazard ratio: 1.64 (95% confidence interval [CI] 1.24-2.17) and interleukin-6-hazard ratio: 1.16 (95% CI 1.05-1.29). Apparent C-statistics of the risk prediction model using clinical variables was 0.605, addition of cathepsin-L1 and interleukin-6 to the model improved discrimination slightly: C = 0.625.

DISCUSSION: Proteomic profiling identified cathepsin-L1 and interleukin-6 as markers for infectious risk in hemodialysis patients. Further studies are needed to replicate the results and to examine possible causality. The developed risk prediction models need considerable improvement before implementation in clinical practice is meaningful.

PMID:34964538 | DOI:10.1111/hdi.12987

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Nevin Manimala Statistics

Development and validation of a risk score for chest pain with suspected non-ST-segment elevation acute coronary syndrome

Ann Noninvasive Electrocardiol. 2021 Dec 29:e12929. doi: 10.1111/anec.12929. Online ahead of print.

ABSTRACT

OBJECTIVE: To investigate a new risk score for acute chest pain with suspected non-ST-segment elevation acute coronary syndrome (NSTE-ACS).

METHODS: Patients who suffered from Chest pain and suspected NSTE-ACS were enrolled as subjects. Predictor variables had been analyzed, and a bootstrap technique was used to evaluate the internal validity of the model, and external validation had been assessed for a prospective cohort study.

RESULTS: Thousand five hundred and sixty-eight patients had been included in this study. Six predictor variables were found to be significant and were used to develop the model. The C-statistic of the model was 0.83, and internal validation revealed the stability of the model and the absence of over-optimism. Patients were given different triage recommendations, and the risk score was prospectively validated.

CONCLUSIONS: A risk score may be a suitable method for assessing the risk of major adverse cardiac events and aiding patient triage in emergency departments among patients with suspected NSTE-ACS.

PMID:34964535 | DOI:10.1111/anec.12929

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Nevin Manimala Statistics

The use of transcutaneous electrical nerve stimulation along with functional tasks for immediate pain relief in individuals with knee osteoarthritis

Eur J Pain. 2021 Dec 29. doi: 10.1002/ejp.1903. Online ahead of print.

ABSTRACT

BACKGROUND: Knee pain is the major complaint in individuals with knee osteoarthritis (OA), and the effects of transcutaneous electrical nerve stimulation (TENS) on knee pain are controversial. The present study applied TENS along with functional tests to investigate its effect on pain level in individuals with mild to moderate knee OA.

METHODS: Twenty volunteers with knee OA classification of graded 2-3 performed four functional tests (stair climb test – SCT, timed up and go test – TUG, 6-minute walk test – 6MWT, knee extensor strength test – KES, and 2-step test from the locomotive syndrome risk test – LSR_2ST) while wearing either an active or inactive TENS. Knee pain level before and after each test was self-accessed by the visual analog scale (VAS). The effect of TENS (active vs. inactive) on pain level was submitted to statistical analyses.

RESULTS: Knee pain during SCT, TUG, and LSR_2ST tests was significantly lower when subjects used the active TENS, compared to using the inactive unit. The effect of the active TENS on pain level was also more significant in subjects with no anxiety or depression.

CONCLUSIONS: The results provided evidence of immediate pain relief in individuals with mild to moderate knee OA when TENS is applied along with functional activities, that usually induced pain in people with knee OA.

PMID:34964537 | DOI:10.1002/ejp.1903

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Nevin Manimala Statistics

Fatty Acid Composition of Proximal Femur Bone Marrow Adipose Tissue in Subjects With Systemic Lupus Erythematous Using 3 T Magnetic Resonance Spectroscopy

J Magn Reson Imaging. 2021 Dec 29. doi: 10.1002/jmri.28038. Online ahead of print.

ABSTRACT

BACKGROUND: Systemic lupus erythematosus (SLE) is a chronic, inflammatory disease with common musculoskeletal manifestations, notably reductions in bone quality. Bone marrow adipose tissue composition and quantity has been previously linked to bone quality and may play a role in SLE pathophysiology but has not been thoroughly studied.

PURPOSE: To use magnetic resonance spectroscopy (MRS) to investigate bone marrow adipose tissue quantity and composition in proximal femur subregions of untreated SLE patients compared to controls and treated patients.

STUDY TYPE: Prospective.

SUBJECTS: A total of 64 female subjects: 28 SLE, 15 glucocorticoid (GC)-treated SLE and 21 matched controls.

FIELD STRENGTH/SEQUENCE: Stimulated echo acquisition mode (STEAM) sequence at 3 T.

ASSESSMENT: MRS was performed at multiple echo times in the femoral neck and trochanter regions and fatty acids (FA) composition was computed.

STATISTICAL TESTS: Intergroup comparisons were carried out using ANOVA. A P value < 0.05 was considered statistically significant.

RESULTS: SLE patients had significantly higher saturated FA compared to controls in both the femoral neck (+0.12) and trochanter (+0.11), significantly lower monounsaturated FA in the trochanter compared to controls (-0.05), and significantly lower polyunsaturated FA in the femoral neck compared to both controls (-0.07) and SLE patients on GC therapy (-0.05).

DATA CONCLUSION: SLE patients have altered proximal femur marrow fat metabolism, which may reflect a manifestation of, or play a role in, the altered inflammatory response of these patients.

EVIDENCE LEVEL: 2 TECHNICAL EFFICACY: Stage 2.

PMID:34964533 | DOI:10.1002/jmri.28038

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Nevin Manimala Statistics

Race does not predict pancreas graft failure after pancreas transplantation in the Modern Era

Clin Transplant. 2021 Dec 29:e14576. doi: 10.1111/ctr.14576. Online ahead of print.

ABSTRACT

BACKGROUND: African-American (AA) has historically been associated with inferior graft survival after pancreas transplantation. However, with the improvement of immunosuppression and surgical technique, we hypothesized that the racial disparity has been neutralized.

METHODS: We analyzed data from the Scientific Registry of Transplant Recipients (1989-2018). Using Kaplan-Meier estimation and Cox proportional hazards regression, we examined the influence of race on pancreatic graft survival.

RESULTS: Before 2009, AA recipients had a higher risk of pancreatic graft failure after adjusting for confounding factors (hazard ratio [HR]: 1.16, 95% confidence interval [CI]: 1.08-1.24), but the risks for Hispanic and Asian recipients were both comparable to their Caucasian counterparts. However, the risk of pancreatic graft failure in AA recipients dropped to 1% and was no longer significant since 2009 (HR: 1.01, 95%CI: 0.88-1.16). Interestingly, donor race showed similar results. Furthermore, the concordance statistic of the complete pancreas donor risk index (including donor race) was 0.582, whereas the concordance did not change when donor race was eliminated from the model.

CONCLUSIONS: AA and other races have shown similar pancreatic graft survival in the modern era. Furthermore, donor racial disparity also seems neutralized; thus, donor race should not be considered as an indicator of pancreatic donor quality. This article is protected by copyright. All rights reserved.

PMID:34964519 | DOI:10.1111/ctr.14576

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Agreement Between Automated and Manual MRI Volumetry in Alzheimer’s Disease: A Systematic Review and Meta-Analysis

J Magn Reson Imaging. 2021 Dec 29. doi: 10.1002/jmri.28037. Online ahead of print.

ABSTRACT

BACKGROUND: Automated magnetic resonance imaging (MRI) volumetry is a promising tool to evaluate regional brain volumes in dementia and especially Alzheimer’s disease (AD).

PURPOSE: To compare automated methods and the gold standard manual segmentation in measuring regional brain volumes on MRI across healthy controls, patients with mild cognitive impairment, and patients with dementia due to AD.

STUDY TYPE: Systematic review and meta-analysis.

DATA SOURCES: MEDLINE, Embase, and PsycINFO were searched through October 2021.

FIELD STRENGTH: 1.0 T, 1.5 T, or 3.0 T.

ASSESSMENT: Two review authors independently identified studies for inclusion and extracted data. Methodological quality was assessed using the Quality Assessment of Diagnostic Accuracy Studies 2 (QUADAS-2).

STATISTICAL TESTS: Standardized mean differences (SMD; Hedges’ g) were pooled using random-effects meta-analysis with robust variance estimation. Subgroup analyses were undertaken to explore potential sources of heterogeneity. Sensitivity analyses were conducted to examine the impact of the within-study correlation between effect estimates on the meta-analysis results.

RESULTS: Seventeen studies provided sufficient data to evaluate the hippocampus, lateral ventricles, and parahippocampal gyrus. The pooled SMD for the hippocampus, lateral ventricles, and parahippocampal gyrus were 0.22 (95% CI -0.50 to 0.93), 0.12 (95% CI -0.13 to 0.37), and -0.48 (95% CI -1.37 to 0.41), respectively. For the hippocampal data, subgroup analyses suggested that the pooled SMD was invariant across clinical diagnosis and field strength. Subgroup analyses could not be conducted on the lateral ventricles data and the parahippocampal gyrus data due to insufficient data. The results were robust to the selected within-study correlation value.

DATA CONCLUSION: While automated methods are generally comparable to manual segmentation for measuring hippocampal, lateral ventricle, and parahippocampal gyrus volumes, wide 95% CIs and large heterogeneity suggest that there is substantial uncontrolled variance. Thus, automated methods may be used to measure these regions in patients with AD but should be used with caution.

EVIDENCE LEVEL: 3 TECHNICAL EFFICACY: Stage 3.

PMID:34964531 | DOI:10.1002/jmri.28037

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Nevin Manimala Statistics

Identification of geographic clusters for temporal heterogeneity with application to dengue surveillance

Stat Med. 2022 Jan 15;41(1):146-162. doi: 10.1002/sim.9227. Epub 2021 Oct 20.

ABSTRACT

Identifying transmission of hot spots with temporal trends is important for reducing infectious disease propagation. Cluster analysis is a particularly useful tool to explore underlying stochastic processes between observations by grouping items into categories by their similarity. In a study of epidemic propagation, clustering geographic regions that have similar time series could help researchers track diffusion routes from a common source of an infectious disease. In this article, we propose a two-stage scan statistic to classify regions into various geographic clusters by their temporal heterogeneity. The proposed scan statistic is more flexible than traditional methods in that contiguous and nonproximate regions with similar temporal patterns can be identified simultaneously. A simulation study and data analysis for a dengue fever infection are also presented for illustration.

PMID:34964513 | DOI:10.1002/sim.9227

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Nevin Manimala Statistics

Population pharmacokinetics and exposure-response relationships of astegolimab in patients with severe asthma

J Clin Pharmacol. 2021 Dec 29. doi: 10.1002/jcph.2021. Online ahead of print.

ABSTRACT

Astegolimab is a fully human immunoglobulin G2 monoclonal antibody (mAb) that binds to the ST2 receptor and blocks the interleukin-33 signaling. It was evaluated in patients with uncontrolled severe asthma in the Phase 2b study (Zenyatta) at doses of 70, 210, 490 mg subcutaneous every 4 weeks (Q4W) for 52 weeks. This work aimed to characterize astegolimab pharmacokinetics, identify influential covariates contributing to its inter-individual variability, and make a descriptive assessment of the exposure-response relationships. A population pharmacokinetic model was developed using data from 368 patients in the Zenyatta study. Predicted average steady-state concentration was used in the subsequent exposure-response analyses, which evaluated efficacy (asthma exacerbation rate) and biomarker endpoints including forced expiratory volume in 1 second, fraction exhaled nitric oxide, blood eosinophils, and soluble ST2. A two-compartment disposition model with first-order elimination and first-order absorption best described the astegolimab pharmacokinetics. The relative bioavailability for the 70 mg dose was 15.3% lower. Baseline body weight, estimated glomerular filtration rate, and eosinophils were statistically correlated with pharmacokinetic parameters, but only body weight had a clinically meaningful influence on the steady-state exposure (ratios exceeding 0.8-1.25). The exposure-response of efficacy and biomarkers were generally flat with a weak trend in favor of the highest dose/exposure. This study characterized astegolimab pharmacokinetics in patients with asthma and showed typical pharmacokinetic behavior as a mAb-based drug. The exposure-response analyses suggested the highest dose tested in the Zenyatta study (490 mg Q4W) performed close to the maximum effect, and no additional response may be expected above it. This article is protected by copyright. All rights reserved.

PMID:34964491 | DOI:10.1002/jcph.2021