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Nevin Manimala Statistics

Perioperative Safety of Combined Augmentation-Mastopexy: An Evaluation of National Database

Ann Plast Surg. 2021 Nov 1;87(5):493-500. doi: 10.1097/SAP.0000000000003022.

ABSTRACT

INTRODUCTION: The safety of combined augmentation-mastopexy is controversial. This study evaluates a national database to analyze the perioperative safety of combined augmentation-mastopexy to either augmentation or mastopexy alone.

METHODS: The American College of Surgeons National Surgical Quality Improvement Program database was queried to identify patients undergoing augmentation mammaplasty and mastopexy from 2005 to 2018. The patients were divided into the following groups: group I, augmentation; group II, mastopexy; group III, combined augmentation-mastopexy. Baseline characteristics and outcomes were compared. Outcomes were 30-day complications, reoperation, and readmission.

RESULTS: We found 5868 (74.2%) augmentation only, 1508 (19.1%) mastopexy only and 534 (6.6%) combined augmentation-mastopexy cases. Mean operative time was highest among the combined group at 129 minutes compared with 127 minutes for mastopexy alone and 66 minutes for augmentation alone (P < 0.01). Rates of any complications and readmission were different among groups (0.8% vs 2.5% vs 1.5% respectively, P < 0.01 and 0.7% vs 1.5% vs 1.5% respectively, P = 0.049), whereas reoperation was not statistically different (1.2% vs 1.4% vs 1.5%, P = 0.75). The incidence of dehiscence (0.6%; P < 0.01) was highest in the combined group. Multivariable logistic regression analysis did not reveal an increased odds of complications, reoperation, or readmission with combined augmentation-mastopexy.

CONCLUSIONS: An evaluation of the nationwide cohort suggests that combined augmentation-mastopexy is a safe procedure in the perioperative period.

PMID:34699429 | DOI:10.1097/SAP.0000000000003022

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Nevin Manimala Statistics

Effects of vibegron on ambulatory blood pressure in patients with overactive bladder: results from a double-blind, placebo-controlled trial

Blood Press Monit. 2021 Oct 25. doi: 10.1097/MBP.0000000000000572. Online ahead of print.

ABSTRACT

OBJECTIVES: To characterize the blood pressure (BP) profile of the new β3-adrenergic receptor agonist, vibegron, in patients with overactive bladder.

METHODS: Patients were randomized to once-daily vibegron 75 mg or placebo for 28 days and underwent ambulatory BP monitoring. The primary endpoint was change from baseline (CFB) to day 28 in mean daytime ambulatory systolic BP (SBP). Secondary endpoints were CFB in mean 24-h SBP and in mean daytime and mean 24-h ambulatory diastolic BP (DBP) and heart rate (HR). Safety was assessed through adverse event reporting.

RESULTS: Of 214 patients randomized, 96 receiving vibegron and 101 receiving placebo had evaluable baseline and day 28 measurements. Overall, 39.6 and 30.7% of patients receiving vibegron and placebo, respectively, had preexisting hypertension. The least squares mean difference (LSMD; 90% confidence interval) between vibegron and placebo in CFB in mean daytime SBP was 0.8 (-0.9, 2.5) mmHg. LSMD in CFB in mean daytime DBP and HR was 0.0 mmHg and 0.9 bpm, respectively. No significant differences between treatments were seen in CFB in mean 24-h SBP (LSMD, 0.6 mmHg), DBP (-0.2 mmHg) or HR (1.0 bpm). The most common treatment-emergent adverse event was hypertension, with rates comparable between groups [vibegron: n = 5 (4.7%); placebo: n = 4 (3.7%)]. One patient receiving vibegron took a prohibited medication (phentermine) known to increase BP.

CONCLUSIONS: Once-daily vibegron had no statistically significant or clinically relevant effects on BP or HR.

PMID:34699409 | DOI:10.1097/MBP.0000000000000572

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Be Sweet to Hospitalized Toddlers During Venipuncture: A Randomized Controlled Trial of Sucrose Compared to Water

Clin J Pain. 2021 Oct 26. doi: 10.1097/AJP.0000000000000998. Online ahead of print.

ABSTRACT

OBJECTIVES: High-quality evidence demonstrates analgesic effects of sweet tasting solutions for infants during painful procedures. However, evidence of the analgesic effects of sucrose beyond 12 months of age is less certain. The aim of this study was to ascertain the efficacy of oral sucrose in hospitalized toddlers (ages 12 to 36▒mo) compared to placebo (water) during venipuncture.

METHODS: Blinded, two-armed randomized controlled trial (RCT) including hospitalized toddlers aged 12-36 months. Toddlers were randomized to either 25% sucrose or water prior to venipuncture, stratified by age (12-24▒mo and >24-36▒mo). Standard of care included topical anesthetics for both groups. Pain assessment included cry duration and FLACC (Face, Legs, Activity, Cry, Consolability) scores. Descriptive statistics and linear models were used to report the percentage of time crying and mean differences in FLACC scores. Data analysis was performed using R version 3.6.3.

RESULTS: A total of 95 toddlers were randomized and 85 subsequently studied. The median percentage of time spent crying between insertion of the first needle and 30s after the end of procedure in both groups was 81% (IQR=66). There was no significant difference in crying time and FLACC scores between groups (P>0.05). When examining effects of sucrose for the younger toddlers (less than 24 months of age) there was a reduction in crying time of 10% and a 1.2-point reduction in mean FLACC scores compared to the toddlers older than 24 months.

DISCUSSION: Findings highlight that toddlers become highly distressed during venipuncture, despite the standard care of topical anesthetics. In addition, sucrose does not effectively reduce distress especially in the older group of toddlers.

PMID:34699407 | DOI:10.1097/AJP.0000000000000998

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Opioid-induced Hyperalgesia in Patients with Chronic Pain: A Systematic Review of Published Cases

Clin J Pain. 2021 Oct 26. doi: 10.1097/AJP.0000000000000994. Online ahead of print.

ABSTRACT

INTRODUCTION: Opioid-induced hyperalgesia (OIH) remains an issue in patients suffering from chronic pain. Multiple cases of OIH in patients with chronic pain exposed to opioids have been reported worldwide. The objective of this systematic review was to summarize the evidence of OIH from clinical reports.

METHODS: We searched the PubMed, Cochrane, EMBASE, and LILACS databases for case reports and case series of OIH published up to December 2020, with the aim to summarize the evidence for OIH in patients with chronic pain from clinical reports and to discuss issues relevant to the clinical diagnosis and management of OIH.

RESULTS: We retrieved and reviewed 41 articles describing 72 cases. Clinical features of OIH were observed in patients of both sexes, all ages, and suffering from various types of pain treated with different classes of opioids. OIH was reported at all doses, but most published studies reported a pattern of OIH following treatment with very high daily doses of opioids (median oral morphine equivalent dose (oMED) of 850▒mg). OIH was diagnosed clinically in all cases. Three different strategies for OIH management were described: opioid rotation, opioid cessation and the use of adjuvant pharmacotherapies. All had statistically similar success rates for OIH treatment: 72%, 57%, and 79%, respectively. The decrease in pain was achieved rapidly (mean: 8▒d; range: 1 to 28▒d). Adjuvant therapies resulted in the largest decrease in dose. Ketamine and dexmedetomidine were the most widely used adjuvant drugs.

CONCLUSION: The key finding is that clinical symptoms of OIH can be resolved when this condition is diagnosed and managed.

PMID:34699405 | DOI:10.1097/AJP.0000000000000994

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Relationship Between Clinical Features and the Arc and Length of Dehiscence in SCDS: A Single Center Review of 42 Cases

Otol Neurotol. 2021 Oct 25. doi: 10.1097/MAO.0000000000003398. Online ahead of print.

ABSTRACT

INTRODUCTION: Superior canal dehiscence syndrome (SCDS) is a rare disorder characterized by an array of audiovestibular symptoms due to a dehiscence of bone overlying the superior semicircular canal (SSC). In the presence of debilitating symptoms, surgical management, to plug or resurface the SCC is performed. Although computed tomography (CT) may overestimate the size or presence of a dehiscence due to a partial volume effect, it remains an invaluable diagnostic tool.

OBJECTIVES: To assess for correlation between the arc and length of dehiscence and clinical symptomology.

METHOD: A single-center, single-operator retrospective analysis of 42 patients who underwent trans mastoid plugging of SCC with confirmed radiological dehiscence of their SSC between January 2008 and July 2019 was undertaken. Patients were assessed based on seven predefined clinical symptoms. Length and arc of dehiscence’s were evaluated by means of high resolution (0.5 mm) CT (HRCT), using multiplanar reconstruction (MPR). Receiver operating characteristics (ROC), and more specifically the area under the ROC curve (AUROC) were used to assess for statistical significance.

RESULTS: Our results demonstrate overall very little correlation between the arc and size of the dehiscence and symptoms. The only statistically significant correlation we found was between length of dehiscence and the presence of aural fullness.

CONCLUSION: SCDS is a debilitating condition with an array of symptoms on presentation. While dehiscence length demonstrated a correlation with aural fullness, no other symptomology in patients with radiologically evident SCDS demonstrated a statistically significant correlation either against the length or arc of dehiscence.

PMID:34699403 | DOI:10.1097/MAO.0000000000003398

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Explanation and Use of Uncertainty Obtained by Bayesian Neural Network Classifiers for Breast Histopathology Images

IEEE Trans Med Imaging. 2021 Oct 26;PP. doi: 10.1109/TMI.2021.3123300. Online ahead of print.

ABSTRACT

Despite the promise of Convolutional neural network (CNN) based classification models for histopathological images, it is infeasible to quantify its uncertainties. Moreover, CNNs may suffer from overfitting when the data is biased. We show that Bayesian-CNN can overcome these limitations by regularizing automatically and by quantifying the uncertainty. We have developed a novel technique to utilize the uncertainties provided by the Bayesian-CNN that significantly improves the performance on a large fraction of the test data (about 6% improvement in accuracy on 77% of test data). Further, we provide a novel explanation for the uncertainty by projecting the data into a low dimensional space through a nonlinear dimensionality reduction technique. This dimensionality reduction enables interpretation of the test data through visualization and reveals the structure of the data in a low dimensional feature space. We show that the Bayesian-CNN can perform much better than the state-of-the-art transfer learning CNN (TL-CNN) by reducing the false negative and false positive by 11% and 7.7% respectively for the present data set. It achieves this performance with only 1.86 million parameters as compared to 134.33 million for TL-CNN. Besides, we modify the Bayesian-CNN by introducing a stochastic adaptive activation function. The modified Bayesian-CNN performs slightly better than Bayesian-CNN on all performance metrics and significantly reduces the number of false negatives and false positives (3% reduction for both). We also show that these results are statistically significant by performing McNemar’s statistical significance test. This work shows the advantages of Bayesian-CNN against the state-of-the-art, explains and utilizes the uncertainties for histopathological images. It should find applications in various medical image classifications.

PMID:34699354 | DOI:10.1109/TMI.2021.3123300

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Nevin Manimala Statistics

The effects of respiratory exercises on partial pressures of gases and anxiety in the acute phase of COVID-19 infection

Physiother Theory Pract. 2021 Oct 26:1-9. doi: 10.1080/09593985.2021.1996497. Online ahead of print.

ABSTRACT

INTRODUCTION: Respiratory exercise in post-COVID-19 significantly improves pulmonary function, exercise capacity and quality of life. Our study aimed to investigate the effect of respiratory exercise on partial pressures of oxygen, carbon dioxide and oxygen saturation in arterial blood and anxiety assessed by the GAD-7 scale in the acute phase of COVID-19 infection.

METHODS: The study was conducted at the Clinical Center, Kragujevac, from June to July 2020. The study was a prospective clinical trial and included 62 patients with the acute-phase of COVID-19 infection (61.3% males, mean age 60.82 ± 11.72). The duration of the comprehensive pulmonary rehabilitation program was 14 days ± 2.28 days. Oxygen saturation and heart rate were determined by using the pulse oximeter, oxygen flow, and arterial blood gas analysis values by using the gas analyzer. The anxiety assessment was measured using the Generalized Anxiety Disorder (GAD-7).

RESULTS: The values of oxygen saturation significantly differed before and after the respiratory exercise sessions (95.77 vs 98.02, respectively; p < .001). After the respiratory exercise program, significantly lower values of the GAD-7 scale were observed compared to the values before the respiratory exercise program (p = .049). A significant negative correlation was observed between oxygen saturation after respiratory exercise and age and presence of chronic obstructive pulmonary disease (ρ = -0.329; p = .013; ρ = -0.334; p = .009, respectively). GAD-7 score after respiratory exercise negatively correlated with chronic obstructive pulmonary disease and malignancy (ρ = -0.285; p = .025; ρ = -0.350; p = .005, respectively).

CONCLUSION: The respiratory exercise program significantly improves oxygen saturation and anxiety levels in COVID-19 patients.

PMID:34698591 | DOI:10.1080/09593985.2021.1996497

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COVID-19 Vaccine-Associated Thrombosis With Thrombocytopenia Syndrome (TTS): A Systematic Review and Post Hoc Analysis

Clin Appl Thromb Hemost. 2021 Jan-Dec;27:10760296211048815. doi: 10.1177/10760296211048815.

ABSTRACT

BACKGROUND: A new clinical syndrome has been recognized following the COVID-19 vaccine, termed thrombosis with thrombocytopenia syndrome (TTS). The following systematic review focuses on extrapolating thrombotic risk factors, clinical manifestations, and outcomes of patients diagnosed with TTS following the COVID-19 vaccine.

METHODS: We utilized the World Health Organization’s criteria for a confirmed and probable case of TTS following COVID-19 vaccination and conducted a systematic review and posthoc analysis using the PRISMA 2020 statement. Data analysis was conducted using SPSS V25 for factors associated with mortality, including age, gender, anti-PF4/heparin antibodies, platelet nadir, D-dimer peak, time to event diagnosis, arterial or venous thrombi.

RESULTS: Of the 175 studies identified, a total of 25 studies with 69 patients were included in this systematic review and post hoc analysis. Platelet nadir (P < .001), arterial or venous thrombi (χ2 = 41.911, P = .05), and chronic medical conditions (χ2 = 25.507, P = .041) were statistically associated with death. The ROC curve analysis yielded D-dimer (AUC = .646) and platelet nadir (AUC = .604) as excellent models for death prediction.

CONCLUSION: Adenoviral COVID-19 vaccines have been shown to trigger TTS, however, reports of patients having received mRNA COVID-19 vaccines are also present. Healthcare providers are recommended to maintain a high degree of suspicion among individuals who have received the COVID-19 vaccine within the last 4 weeks.

PMID:34698582 | DOI:10.1177/10760296211048815

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The Role of Sample Size to Attain Statistically Comparable Groups – A Required Data Preprocessing Step to Estimate Causal Effects With Observational Data

Eval Rev. 2021 Oct 26:193841X211053937. doi: 10.1177/0193841X211053937. Online ahead of print.

ABSTRACT

Propensity score methods provide data preprocessing tools to remove selection bias and attain statistically comparable groups – the first requirement when attempting to estimate causal effects with observational data. Although guidelines exist on how to remove selection bias when groups in comparison are large, not much is known on how to proceed when one of the groups in comparison, for example, a treated group, is particularly small, or when the study also includes lots of observed covariates (relative to the treated group’s sample size). This article investigates whether propensity score methods can help us to remove selection bias in studies with small treated groups and large amount of observed covariates. We perform a series of simulation studies to study factors such as sample size ratio of control to treated units, number of observed covariates and initial imbalances in observed covariates between the groups of units in comparison, that is, selection bias. The results demonstrate that selection bias can be removed with small treated samples, but under different conditions than in studies with large treated samples. For example, a study design with 10 observed covariates and eight treated units will require the control group to be at least 10 times larger than the treated group, whereas a study with 500 treated units will require at least, only, two times bigger control group. To confirm the usefulness of simulation study results for practice, we carry out an empirical evaluation with real data. The study provides insights for practice and directions for future research.

PMID:34698560 | DOI:10.1177/0193841X211053937

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Nevin Manimala Statistics

Pathogenesis, Symptomatology, and Transmission of SARS-CoV-2 through Analysis of Viral Genomics and Structure

mSystems. 2021 Oct 26;6(5):e0009521. doi: 10.1128/mSystems.00095-21. Epub 2021 Oct 26.

ABSTRACT

The novel coronavirus SARS-CoV-2, which emerged in late 2019, has since spread around the world and infected hundreds of millions of people with coronavirus disease 2019 (COVID-19). While this viral species was unknown prior to January 2020, its similarity to other coronaviruses that infect humans has allowed for rapid insight into the mechanisms that it uses to infect human hosts, as well as the ways in which the human immune system can respond. Here, we contextualize SARS-CoV-2 among other coronaviruses and identify what is known and what can be inferred about its behavior once inside a human host. Because the genomic content of coronaviruses, which specifies the virus’s structure, is highly conserved, early genomic analysis provided a significant head start in predicting viral pathogenesis and in understanding potential differences among variants. The pathogenesis of the virus offers insights into symptomatology, transmission, and individual susceptibility. Additionally, prior research into interactions between the human immune system and coronaviruses has identified how these viruses can evade the immune system’s protective mechanisms. We also explore systems-level research into the regulatory and proteomic effects of SARS-CoV-2 infection and the immune response. Understanding the structure and behavior of the virus serves to contextualize the many facets of the COVID-19 pandemic and can influence efforts to control the virus and treat the disease. IMPORTANCE COVID-19 involves a number of organ systems and can present with a wide range of symptoms. From how the virus infects cells to how it spreads between people, the available research suggests that these patterns are very similar to those seen in the closely related viruses SARS-CoV-1 and possibly Middle East respiratory syndrome-related CoV (MERS-CoV). Understanding the pathogenesis of the SARS-CoV-2 virus also contextualizes how the different biological systems affected by COVID-19 connect. Exploring the structure, phylogeny, and pathogenesis of the virus therefore helps to guide interpretation of the broader impacts of the virus on the human body and on human populations. For this reason, an in-depth exploration of viral mechanisms is critical to a robust understanding of SARS-CoV-2 and, potentially, future emergent human CoVs (HCoVs).

PMID:34698547 | DOI:10.1128/mSystems.00095-21