Categories
Nevin Manimala Statistics

Transcarotid revascularization in obese patients

Vascular. 2022 Jun 2:17085381221106326. doi: 10.1177/17085381221106326. Online ahead of print.

ABSTRACT

OBJECTIVE: Transcarotid revascularization (TCAR) is a minimally invasive hybrid surgical carotid stenting technique which utilizes cerebral flow reversal as embolic protection during carotid lesion manipulation. This investigation was performed to define the perioperative risks associated with this operation in the obese patient.

METHODS: A retrospective review of tandem carotid revascularization databases maintained at two high-volume health systems was performed to capture all TCARs performed between 2015 and 2022. A threshold of body mass index of 35 kg/m2 defined the “obese” patient. Demographics, intraoperative, perioperative, and follow-up characteristics were compared using univariate analysis.

RESULTS: We performed 793 TCAR procedures that qualified for study inclusion within the prespecified time. After applying our obesity definition, 129 patients qualified as obese and were compared to the remainder. There were no significant differences in baseline demographics as comparable Charlson Comorbidity Indices were noted between groups; however, obese patients had a significantly higher prevalence of hypertension, hyperlipidemia, and diabetes. Intraoperative, case complexity in the obese patients did not seem to be increased, as measured by operative time (68.4 ± 23.0 vs 64.2 ± 25.8 min, p = 0.09), fluoroscopic time (4.9 ± 3.2 vs 4.6 ± 3.6 min, p = 0.38), and estimated blood loss (40.6 ± 49.0 vs 46.6 ± 49.4 min, p = 0.22). Similarly, no disparities were observed with respect to ipsilateral stroke (3.1 vs. 1.7%, p = 0.29), contralateral stroke (0 vs. 0.2%, p > 0.99), death (0 vs. 1.1%, p = 0.61), and stroke/death (3.1 vs. 3.0%, p > 0.99) in the 30-day perioperative period. Both cohorts were followed for approximately 1 year (12.0 ± 13.4 vs 11.6 ± 13.4 months, p = 0.76). During this period, rates of ipsilateral stroke (3.1% vs. 2.7%, p > 0.99), contralateral stroke (1.1 vs. 0.8%, p > 0.99), and death (4.7 vs. 6.2%, p = 0.68) were similar.

CONCLUSIONS: TCAR performed in the obese population was not more challenging by intraoperative characteristics and did not result in a statistically higher incidence of adverse events in the perioperative phase.

PMID:35653693 | DOI:10.1177/17085381221106326

Categories
Nevin Manimala Statistics

A bacteriological survey of fresh minced beef on sale at retail outlets in Scotland in 2019: three food-borne pathogens, hygiene process indicators and phenotypic antimicrobial resistance

J Food Prot. 2022 Jun 2. doi: 10.4315/JFP-22-051. Online ahead of print.

ABSTRACT

The health and economic burden of foodborne illness is high, with approximately 2.4 million cases occurring annually in the United Kingdom. A survey to understand the baseline microbial quality and prevalence of food-related hazards of fresh beef mince on retail sale could inform risk assessment, management and communication to ensure the safety of this commodity. In such a survey, a two-stage sampling design was used to reflect variations in population density and the market share of five categories of retail outlets in Scotland. From January to December 2019, 1009 fresh minced beef samples were collected from 15 Geographic Areas. The microbial quality of each sample was assessed using Aerobic Colony Count (ACC) and generic E. coli count. Samples were cultured for Campylobacter and Salmonella and PCR was used to detect target genes (stx1 all variants, stx2 a-g, and rfbO157) for Shiga toxin-producing Escherichia coli (STEC). The presence of viable E. coli O157 and STEC in samples with a positive PCR signal was confirmed via culture and isolation. Phenotypic antimicrobial sensitivity patterns of cultured pathogens and 100 generic E. coli isolates were determined, mostly via disc diffusion. The median ACC and generic E. coli counts were 6.4 x 105 (Inter-quartile range (IQR):6.9 x 104 to 9.6 x 106) and <10 cfu per gram (IQR:<10 to 10) of minced beef respectively. The prevalence was 0.1% (95% confidence interval C.I. 0 to 0.7%) for Campylobacter, 0.3% (95% C.I. 0 to 1%) for Salmonella, 22% (95% C.I. 20% to 25%) for PCR positive STEC and 4% (95% C.I. 2 to 5%) for culture positive STEC. The evidence for phenotypic antimicrobial resistance (AMR) detected did not give cause for concern, mainly occurring in a few generic E. coli isolates as single non-susceptibilities to first-line active substances. The low prevalence of pathogens and phenotypic AMR is encouraging but ongoing consumer food-safety education is necessary to mitigate the residual public health risk.

PMID:35653627 | DOI:10.4315/JFP-22-051

Categories
Nevin Manimala Statistics

Efficacy and Safety of Intravenous Golimumab in Ankylosing Spondylitis Patients With Early and Late Disease Through 1 Year of the GO-ALIVE Study

J Clin Rheumatol. 2022 Jun 1. doi: 10.1097/RHU.0000000000001853. Online ahead of print.

ABSTRACT

BACKGROUND/OBJECTIVE: This post hoc analysis assessed efficacy and safety of intravenous (IV) golimumab in ankylosing spondylitis (AS) patients with early disease (ED) versus late disease (LD).

METHODS: The phase 3, double-blind, GO-ALIVE study randomized patients to IV golimumab 2 mg/kg at weeks 0 and 4 and then every 8 weeks through week 52, or placebo at weeks 0, 4, and 12 with crossover to IV golimumab at week 16. Clinical efficacy was assessed by ≥20% improvement in Assessment of Spondyloarthritis International Society response criteria (ASAS20), ≥50% improvement in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI 50), and Ankylosing Spondylitis Disease Activity Score (ASDAS) <1.3 (inactive disease). Using self-reported duration of inflammatory back pain (IBP), patients were grouped into quartiles: first = ED and fourth = LD. Descriptive statistics summarized efficacy and safety findings through 1 year.

RESULTS: Early disease patients (n = 60) were ~10 years younger and had shorter median AS (IBP) symptom duration (2-3 years) versus LD patients (n = 52; 21-24 years). At week 16, numerically higher proportions of golimumab- than placebo-treated patients achieved ASAS20 (ED: 71% vs. 32%; LD: 67% vs. 21%), BASDAI 50 (ED: 40% vs. 12%; LD: 33% vs. 7%), and ASDAS <1.3 (ED: 17% vs. 4%; LD 8% vs. 0%) regardless of IBP duration. Efficacy was durable through 1 year of treatment; however, response rates were numerically higher in patients with ED versus LD. Through week 60, adverse events and serious adverse events, respectively, were reported by 46% and 3% of ED patients and 61% and 2% of LD patients.

CONCLUSION: Prompt diagnosis of AS and early treatment with IV golimumab may yield more robust improvements in disease activity.

PMID:35653615 | DOI:10.1097/RHU.0000000000001853

Categories
Nevin Manimala Statistics

Repair of Dental Restorations: A 10-year Retrospective Analysis of Clinical Data

Oper Dent. 2022 Jun 2. doi: 10.2341/20-217-C. Online ahead of print.

ABSTRACT

OBJECTIVES: This study collected and analyzed clinical data regarding the repair of dental restorations in patients treated in the clinics of a dental school over 10 years.

METHODS AND MATERIALS: Data related to repair procedures for permanent tooth restorations were extracted from the digital dental records system and filtered according to year (January 1, 2008, to December 31, 2017), age (<30, 30-60, >60), tooth group, and dental surfaces. Data were analyzed with descriptive statistics in terms of the absolute and relative frequency, and chi-square tests (95% confidence) were used to compare the frequency of repairs between years, age, tooth, and dental surfaces.

RESULTS: A total of 48,915 dental records were accessed by searching for general restorative procedures, of which 1,408 were repairs of dental restorations on permanent teeth. The number of repairs per year increased over the period assessed, and there was a significant increase in the years 2016 and 2017. Individuals aged between 30 and 60 years received the largest number of repairs, with significantly more repairs than the other groups. Regarding the tooth group and surface, the canines and the incisal and lingual surfaces received the least number of repairs.

CONCLUSIONS: The number of repairs increased over the study period. When comparing frequencies between groups, those belonging to the 30- to 60-years of age group received more repairs; the least repaired surfaces were the lingual and the incisal.

PMID:35653602 | DOI:10.2341/20-217-C

Categories
Nevin Manimala Statistics

Effectiveness of Paxlovid in Reducing Severe COVID-19 and Mortality in High Risk Patients

Clin Infect Dis. 2022 Jun 2:ciac443. doi: 10.1093/cid/ciac443. Online ahead of print.

ABSTRACT

BACKGROUND: Paxlovid was granted emergency use authorization for the treatment of mild to moderate COVID-19, based on the interim analysis of EPIC-HR trial. Paxlovid effectiveness needs to be assessed in a noncontrolled setting. In this study we used population-based real world data to evaluate the effectiveness of Paxlovid.

METHODS: The database of the largest healthcare provider in Israel was used to identify all adults aged 18 years or older with first ever positive test for SARS-CoV-2 between January and February 2022, who were at high risk for severe COVID-19 and had no contraindications for Paxlovid use. Patients were included irrespective of their COVID-19 vaccination status. Cox hazard regression was used to estimate the 28 day HR for severe COVID-19 or mortality with Paxlovid examined as time-dependent variable.

RESULTS: Overall, 180,351 eligible were included, of them only 4,737 (2.6%) were treated with Paxlovid, and 135,482 (75.1%) had adequate COVID-19 vaccination status. Both Paxlovid and adequate COVID-19 vaccination status were associated with significant decrease in the rate of severe COVID-19 or mortality with adjusted HR 0.54 (95% CI, 0.39-0.75) and 0.20 (95% CI, 0.17-0.22), respectively. Paxlovid appears to be more effective in older patients, immunosuppressed patients, and patients with underlying neurological or cardiovascular disease (interaction p-value <0.05 for all). No significant interaction was detected between Paxlovid treatment and COVID-19 vaccination status.

CONCLUSIONS: This study suggests that in the era of omicron and in real life setting Paxlovid is highly effective in reducing the risk of severe COVID-19 or mortality.

PMID:35653428 | DOI:10.1093/cid/ciac443

Categories
Nevin Manimala Statistics

Comparison of three PCR-based methods to detect Loa loa and Mansonella perstans in long-term frozen storage dried blood spots

Trop Med Int Health. 2022 Jun 2. doi: 10.1111/tmi.13786. Online ahead of print.

ABSTRACT

OBJECTIVES: Loa loa and Mansonella perstans are two very common filarial species in Africa. Although microscopy is the traditional diagnostic method for human filariasis, several polymerase chain reaction methods have emerged as an alternative approach for identifying filarial parasites. The aim of this study is to compare three molecular methods and decide which is the most suitable for diagnosing human loiasis and mansonellosis in non-endemic regions using dried blood spot (DBS) as a medium for sample collection and storage.

METHODS: 100 DBS samples, with their corresponding thin and thick blood smears, were selected for this study. Microscopy was used as the reference method to diagnose and calculate the microfilaraemia. Filarial DNA was extracted using the saponin/Chelex method and the DNA isolated was assayed by Filaria-real time-PCR, Filaria-Nested PCR, and cytochrome oxidase I PCR. All PCR products were subsequently purified and sequenced. The statistical values for each molecular test were calculated and compared.

RESULTS: Overall, 64 samples were identified as negative by all tests and a further 36 samples were positive by at least one of the methods used. The sensitivity and specificity were similar for the different molecular methods, all of which demonstrated good agreement with microscopy.

CONCLUSIONS: Based on this study, and from a practical point of view (single and short amplification round), the optimal technique for diagnosing filarial infection in non-endemic regions is Filaria-real time-PCR, which presents high sensitivity and specificity and is also able to detect a wide range of human filariae.

PMID:35653502 | DOI:10.1111/tmi.13786

Categories
Nevin Manimala Statistics

Investigation of thiol-disulfide homeostasis and ischemia-modified albumin levels in patients with hidradenitis supurativa

J Cosmet Dermatol. 2022 Jan 12. doi: 10.1111/jocd.14753. Online ahead of print.

ABSTRACT

BACKGROUND: Hidradenitis suppurativa (HS) is a chronic inflammatory skin disease. The pathogenesis of HS is not clear, and the triggering mechanism for the initiation of the disease is still a controversy.

AIMS: The present study aims to investigate the relationship between thiol-disulfide homeostasis (TDH), ischemia-modified albumin (IMA), and HS. To our knowledge, this will be the first report evaluating TDH and IMA status in HS.

PATIENTS/METHODS: The study included 30 patients with HS as the patient group and 30 healthy individuals as the control group. For determination of HS severity, Hurley and Hidradenitis suppurativa physician global assessment (PGA) scores were used. One tube venous blood specimen from every participant was obtained. IMA and TDH tests were analyzed in sera of participants. The results were evaluated statistically.

RESULTS: Disulfide (p < 0.001), Index I (p = 0.001), and Index II (p = 0.001) levels in HS group were significantly higher than control group. IMA levels in patients with higher Hurley scores are significantly higher (p = 0.032, r = 0.39). A positive correlation was observed between IMA level and disease duration (p = 0.021, r = 0.42).

CONCLUSIONS: The shift in thiol/disulfide balance toward disulfide and significant increase in IMA levels put out the importance of oxidation status in HS etiopathogenesis.

PMID:35653419 | DOI:10.1111/jocd.14753

Categories
Nevin Manimala Statistics

An Observation Study of Urinary Biomarkers Exploratory in Alzheimer’s Disease using High Resolution Mass Spectrometry

Biomed Chromatogr. 2022 Jun 2:e5421. doi: 10.1002/bmc.5421. Online ahead of print.

ABSTRACT

Alzheimer’s disease (AD) is regarded as a progressive neurodegenerative dementia, characterized by degeneration of distinct neuronal populations. A case-control study was carried out by using high resolution mass spectrometry to explore AD associated urinary metabolic biomarkers from 30 AD patients and 30 cognitively normal (CN) individuals, respectively. In total, 49 metabolites were determined and validated as known compounds by LC/MS analysis. With two sample t-test statistical analysis (p<0.05), 19 metabolites were shown to be significantly differed from AD to CN. A diagnostic model of receiver-operator characteristic (ROC) curve was constructed with a combination of 9 selected metabolites and yielded a separation with an area under the curve value of 0.976 between two groups. This study indicated urinary metabolites showed a significant expression between AD and CN. AD related metabolites enable to satisfy the diagnostic power of disease discrimination. Additionally, as a non-invasive approach, urine collection provides its convenience in clinical diagnosis of AD.

PMID:35653409 | DOI:10.1002/bmc.5421

Categories
Nevin Manimala Statistics

A scoping review of randomized trials assessing the impact of n-of-1 trials on clinical outcomes

PLoS One. 2022 Jun 2;17(6):e0269387. doi: 10.1371/journal.pone.0269387. eCollection 2022.

ABSTRACT

BACKGROUND: The single patient (n-of-1) trial can be used to resolve therapeutic uncertainty for the individual patient. Treatment alternatives are systematically tested against each other, generating patient-specific data used to inform an individualized treatment plan. We hypothesize that clinical decisions informed by n-of-1 trials improve patient outcomes compared to usual care. Our objective was to provide an overview of the clinical trial evidence on the effect of n-of-1 trials on clinical outcomes.

METHODS: A systematic search of medical databases, trial registries, and gray literature was performed to identify trials assessing clinical outcomes in a group of patients undergoing an n-of-1 trial compared to those receiving usual care for any clinical condition. We abstracted elements related to study design and results and assessed risk of bias for both the overall randomized trials and the n-of-1 trials. The review was registered on PROSPERO. (CRD: 42020166490).

FINDINGS: Twelve randomized trials of the n-of-1 approach were identified in conditions spanning chronic pain, osteoarthritis, chronic irreversible airflow limitation, attention-deficit hyperactivity disorder, hyperlipidemia, atrial fibrillation, statin intolerance, and hypertension. One trial showed a statistically significant benefit in the primary outcome. Only one reached the pre-specified sample size target. Secondary outcomes showed modest benefits, including decreasing medication use, fewer atrial fibrillation episodes, and improved patient satisfaction.

INTERPRETATION: Very few trials have been undertaken to assess the effectiveness of n-of-1 trials in improving clinical outcomes, and most trials were underpowered for the primary outcome. Barriers to enrollment and retention in these trials should be explored, as well-powered randomized trials are needed to clarify the clinical impact of n-of-1 trials and assess their utility in clinical practice.

PMID:35653405 | DOI:10.1371/journal.pone.0269387

Categories
Nevin Manimala Statistics

sumSTAAR: A flexible framework for gene-based association studies using GWAS summary statistics

PLoS Comput Biol. 2022 Jun 2;18(6):e1010172. doi: 10.1371/journal.pcbi.1010172. Online ahead of print.

ABSTRACT

Gene-based association analysis is an effective gene-mapping tool. Many gene-based methods have been proposed recently. However, their power depends on the underlying genetic architecture, which is rarely known in complex traits, and so it is likely that a combination of such methods could serve as a universal approach. Several frameworks combining different gene-based methods have been developed. However, they all imply a fixed set of methods, weights and functional annotations. Moreover, most of them use individual phenotypes and genotypes as input data. Here, we introduce sumSTAAR, a framework for gene-based association analysis using summary statistics obtained from genome-wide association studies (GWAS). It is an extended and modified version of STAAR framework proposed by Li and colleagues in 2020. The sumSTAAR framework offers a wider range of gene-based methods to combine. It allows the user to arbitrarily define a set of these methods, weighting functions and probabilities of genetic variants being causal. The methods used in the framework were adapted to analyse genes with large number of SNPs to decrease the running time. The framework includes the polygene pruning procedure to guard against the influence of the strong GWAS signals outside the gene. We also present new improved matrices of correlations between the genotypes of variants within genes. These matrices estimated on a sample of 265,000 individuals are a state-of-the-art replacement of widely used matrices based on the 1000 Genomes Project data.

PMID:35653402 | DOI:10.1371/journal.pcbi.1010172