Categories
Nevin Manimala Statistics

Bioprotection of Zea mays L. from aflatoxigenic Aspergillus flavus by Loigolactobacillus coryniformis BCH-4

PLoS One. 2022 Aug 2;17(8):e0271269. doi: 10.1371/journal.pone.0271269. eCollection 2022.

ABSTRACT

Fungal infection causes deterioration, discoloration, and loss of nutritional values of food products. The use of lactic acid bacteria has diverse applications in agriculture to combat pathogens and to improve the nutritional values of cereal grains. The current research evaluated the potential of Loigolactobacillus coryniformis BCH-4 against aflatoxins producing toxigenic Aspergillus flavus strain. The cell free supernatant (CFS) of Loig. coryniformis was used for the protection of Zea mays L. treated with A. flavus. No fungal growth was observed even after seven days. The FT-IR spectrum of untreated (T1: without any treatment) and treated maize grains (T2: MRS broth + A. flavus; T3: CFS + A. flavus) showed variations in peak intensities of functional group regions of lipids, proteins, and carbohydrates. Total phenolics, flavonoid contents, and antioxidant activity of T3 were significantly improved in comparison with T1 and T2. Aflatoxins were not found in T3 while observed in T2 (AFB1 and AFB2 = 487 and 16 ng/g each). HPLC analysis of CFS showed the presence of chlorogenic acid, p-coumaric acid, 4-hydroxybenzoic acid, caffeic acid, sinapic acid, salicylic acid, and benzoic acid. The presence of these acids in the CFS of Loig. coryniformis cumulatively increased the antioxidant contents and activity of T3 treated maize grains. Besides, CFS of Loig. coryniformis was passed through various treatments (heat, neutral pH, proteolytic enzymes and catalase), to observe its stability. It suggested that the inhibitory potential of CFS against A. flavus was due to the presence of organic acids, proteinaceous compounds and hydrogen peroxide. Conclusively, Loig. coryniformis BCH-4 could be used as a good bioprotecting agent for Zea mays L. by improving its nutritional and antioxidant contents.

PMID:35917314 | DOI:10.1371/journal.pone.0271269

Categories
Nevin Manimala Statistics

Bayesian and frequentist approaches to sequential monitoring for futility in oncology basket trials: A comparison of Simon’s two-stage design and Bayesian predictive probability monitoring with information sharing across baskets

PLoS One. 2022 Aug 2;17(8):e0272367. doi: 10.1371/journal.pone.0272367. eCollection 2022.

ABSTRACT

This article discusses and compares statistical designs of basket trial, from both frequentist and Bayesian perspectives. Baskets trials are used in oncology to study interventions that are developed to target a specific feature (often genetic alteration or immune phenotype) that is observed across multiple tissue types and/or tumor histologies. Patient heterogeneity has become pivotal to the development of non-cytotoxic treatment strategies. Treatment targets are often rare and exist among several histologies, making prospective clinical inquiry challenging for individual tumor types. More generally, basket trials are a type of master protocol often used for label expansion. Master protocol is used to refer to designs that accommodates multiple targets, multiple treatments, or both within one overarching protocol. For the purpose of making sequential decisions about treatment futility, Simon’s two-stage design is often embedded within master protocols. In basket trials, this frequentist design is often applied to independent evaluations of tumor histologies and/or indications. In the tumor agnostic setting, rarer indications may fail to reach the sample size needed for even the first evaluation for futility. With recent innovations in Bayesian methods, it is possible to evaluate for futility with smaller sample sizes, even for rarer indications. Novel Bayesian methodology for a sequential basket trial design based on predictive probability is introduced. The Bayesian predictive probability designs allow interim analyses with any desired frequency, including continual assessments after each patient observed. The sequential design is compared with and without Bayesian methods for sharing information among a collection of discrete, and potentially non-exchangeable tumor types. Bayesian designs are compared with Simon’s two-stage minimax design.

PMID:35917296 | DOI:10.1371/journal.pone.0272367

Categories
Nevin Manimala Statistics

Objective Evaluation of Neurogenic Intermittent Claudication for Patients with Lumbar Spinal Stenosis Based on Plantar Pressure Analysis

Spine (Phila Pa 1976). 2022 Aug 2. doi: 10.1097/BRS.0000000000004444. Online ahead of print.

ABSTRACT

STUDY DESIGN: A cross-sectional study.

OBJECTIVE: To quantify the severity of neurogenic intermittent claudication (NIC) for patients with lumbar spinal stenosis (LSS) based on center of pressure (COP) trajectory.

SUMMARY OF BACKGROUND DATA: NIC is one of the typical symptoms of LSS. So far, the severity level of NIC is mainly evaluated by subjective description of patients, which might be biased by patients’ background differences and thus lead to ineffective diagnosis or inappropriate treatment for LSS. Therefore, it remains necessary to develop a reliable clinical technique for quantitative evaluation of NIC to achieve more effective therapy for LSS.

METHODS: In the present study, the Footscan® pressure system was used to detect the COP trajectory. The real-time walking distance (rtWD) and the corresponding displacement of medial-lateral COP (ML-COP) were calculated based on the trajectory. The differences of ML-COP between LSS group and control group were analyzed using one-way repeated measures ANOVA. Regression and Pearson correlation analysis were used to investigate the correlation between rtWD and ML-COP, as well as the relation between the Oxford Claudication Score (OCS) and clinical evaluation indicators.

RESULTS: The present study included 31 LSS patients and 31 healthy controls. There were no significant differences in demographic data between the two groups (P>0.05). The results indicated that ML-COP would increase with the number of laps in the LSS group while not in the control group. Also, a linear relationship was identified between the ML-COP and rtWD for LSS patients (R2>0.80, P<0.05). Since the incremental rate of ML-COP for LSS patients was reflected by the regression coefficients of the linear regression analysis, thus the regression coefficients were defined as the claudication correlation coefficients (CCC). In addition, it was indicated by the statistical analysis that there was a strong positive correlation between OCS and CCC (r=0.96; P<0.001), and a medium negative correlation with FWD (r=-0.67; P<0.001). It was also noticed that there was no significant correlation between the average ML-COP and OCS (r=-0.03; P=0.864).

CONCLUSION: The ML-COP of LSS patients would increase with the patients’ walking distance. This incremental rate, characterized by the claudication correlation coefficient (CCC), would be used as an effective indicator to quantify the severity level of the NIC, for potentially more accurate and reliable diagnosis, evaluation, and treatment of LSS.

LEVEL OF EVIDENCE: 3.

PMID:35917289 | DOI:10.1097/BRS.0000000000004444

Categories
Nevin Manimala Statistics

Early Adherence to Prescribed Brace Wear for Adolescent Idiopathic Scoliosis is Associated with Future Brace Wear

Spine (Phila Pa 1976). 2022 Aug 2. doi: 10.1097/BRS.0000000000004446. Online ahead of print.

ABSTRACT

STUDY DESIGN: Retrospective cohort study.

OBJECTIVE: To assess if initial adherence to prescribed brace wear for adolescent idiopathic scoliosis (AIS) predicts future adherence and curve improvement.

SUMMARY OF BACKGROUND DATA: AIS bracing can be effective if patients adhere to prescribed brace wear. Previous research has associated age, sex, and brace prescription length with future adherence. We hypothesize that a patient’s initial adherence to brace wear may be associated with future adherence and outcomes.

METHODS: Consecutive AIS patients who met the Scoliosis Research Society (SRS) criteria for bracing from 2015-2019 at a single-center were reviewed. Patients were stratified into groups based on their adherence during the initial one-month brace wean-in period – adherent patients were defined as wearing the brace greater than 80% of the daily prescribed amount. Brace wear was recorded by a thermosensor and assessed during the wean-in period, six-month, 12-month, and 24-month post-bracing appointments. Statistical testing was conducted to analyze if initial adherence was associated with future adherence, curve change, and bracing success – defined as reaching Risser stage four with a Cobb angle less than 40 degrees.

RESULTS: Sixty patients (mean age – 12.5 y) were included, of which the majority were females (83%) with thoracic curves (70%). Thirty-two patients were considered adherent, and this cohort demonstrated improved adherence relative to the non-adherent group at the six, 12, and 24-month appointments (P<0.001). Adherent patients also showed a significant reduction in their scoliosis at the 12-month appointment unlike non-adherent patients (P<0.001). Ninety-seven percent of adherent patients achieved bracing success compared to 71% of non-adherent (P=0.016). Females were more likely to be adherent than males.

CONCLUSION: Initial adherence to prescribed AIS brace wear was associated with future adherence, bracing success, and curve improvement. Early recognition of non-adherence may offer an opportunity for supportive intervention to improve brace wear behavior.

PMID:35917288 | DOI:10.1097/BRS.0000000000004446

Categories
Nevin Manimala Statistics

Validation of Age-adjusted Ideal Sagittal Alignment in Terms of Proximal Junctional Failure and Clinical Outcomes in Adult Spinal Deformity

Spine (Phila Pa 1976). 2022 Aug 2. doi: 10.1097/BRS.0000000000004449. Online ahead of print.

ABSTRACT

STUDY DESIGN: Retrospective study.

OBJECTIVE: To validate the age-adjusted ideal sagittal alignment in terms of proximal junctional failure (PJF) and clinical outcomes.

SUMMARY OF BACKGROUND: It is reported that optimal sagittal correction with regard to the age-adjusted ideal sagittal alignment reduces the risk of PJF development. However, few studies have validated this concept. The age-considered optimal correction is likely to be undercorrection in terms of conventional surgical target, such as pelvic incidence (PI) – lumbar lordosis (LL) within ±9°. Therefore, the clinical impact of age-adjusted sagittal alignment should be evaluated along with radiographic effect.

METHODS: Adult spinal deformity (ASD) patients, aged ≥50 years, who underwent ≥4-level fusion to sacrum with a minimum of four-years of follow-up data were included in this study. Radiographic risk factors for PJF (including age-adjusted ideal PI-LL) were evaluated with multivariate analyses. Three groups were created based on PI-LL offset between age-adjusted ideal PI-LL and actual PI-LL: undercorrection, ideal correction, and overcorrection. Clinical outcomes were compared among the three groups.

RESULTS: This study included 194 ASD patients. The mean age was 68.5 years and there were 172 females (88.7%). PJF developed in 99 patients (51.0%) at a mean postoperative period of 14.9 months. Multivariate analysis for PJF revealed that only PI-LL offset group had statistical significance. The proportion of patients with PJF was greatest in the overcorrection group followed by the ideal correction and undercorrection groups. Overcorrected patients regard to the age-adjusted ideal alignment showed poorer clinical outcomes than the other patient groups.

CONCLUSION: Overcorrection relative to age-adjusted sagittal alignment increases the risk of PJF development and is associated with poor clinical outcomes. Older patients and those with small PI are likely to be overcorrected in terms of the age-adjusted PI-LL target. Therefore, the age-adjusted alignment should be considered more strictly in these patients.

PMID:35917282 | DOI:10.1097/BRS.0000000000004449

Categories
Nevin Manimala Statistics

Intradermal Botulinum Toxin A Injection Versus Topical 2% Glycopyrrolate for the Treatment of Primary Facial Hyperhidrosis: A Pilot Study and Review of Literature

Dermatol Surg. 2022 Aug 1;48(8):843-848. doi: 10.1097/DSS.0000000000003490. Epub 2022 Jun 17.

ABSTRACT

BACKGROUND: Facial hyperhidrosis (HH), a common problem with both cosmetic and psychological impact, interferes with quality of life. Wide range of treatment options is available for HH. Finding the most effective and yet a safe, tolerable option is the main target.

OBJECTIVE: To evaluate and compare clinical efficacy, safety, and tolerability of topical 2% glycopyrrolate versus intradermal Botulinum toxin A injection in facial HH treatment.

MATERIALS AND METHODS: Twenty-four patients with primary facial HH were randomly divided into 2 equal groups: Group A included patients treated by intradermal Botulinum toxin A injection and Group B included patients treated by topical glycopyrrolate gel 2%. Starch iodine test was performed before and after treatment to assess response, along with Hyperhidrosis Disease Severity Scale, Dermatology Life Quality Index (DLQI), and patient satisfaction.

RESULTS: Both modalities showed complete response in 75% of cases with a longer duration of action in botulinum toxin group up to 6 months. Side effects were minor and temporary. Both Hyperhidrosis Disease Severity Scale and DLQI showed statistically significant improvement after treatment.

CONCLUSION: Topical glycopyrrolate 2% showed comparable results to Botulinum toxin A in facial HH treatment with faster onset but shorter duration of action.

PMID:35917265 | DOI:10.1097/DSS.0000000000003490

Categories
Nevin Manimala Statistics

Quality of Cure in Depth of Commercially Available Bulk-fill Composites: A Layer-by-layer Mechanical and Biological Evaluation

Oper Dent. 2022 Aug 2. doi: 10.2341/21-084-L. Online ahead of print.

ABSTRACT

Despite their popularity, the use of bulk-fill composites remains controversial, both in terms of their properties and their in-depth development. The objectives of the present work were (1) to provide a more comprehensive evaluation of the quality of cure in depth of commercially available bulk-fill composites by combining various key mechanical and biological characterization methods, (2) to evaluate the inter-material differences when optimally cured, and (3) to evaluate the efficiency of an antioxidant-N-acetyl-cysteine (NAC)-to restrain the adverse effects of the leached components on cell viability. Nine bulk-fill composites (including flowable and high-viscosity materials) were investigated and compared to two conventional resin-based composites, one flowable and one high-viscosity restorative material. The materials were injected or packed into Teflon molds of various configurations, up to 6 mm material thickness. They were then light-cured from the top for 20 seconds with Bluephase G2 (Ivoclar Vivadent, irradiance = 1050 mW/cm2). The following physicomechanical properties were measured for the upper (0-2 mm), intermediate (2-4 mm), and lower (4-6 mm) layers: degree of conversion using Raman Spectrometry (DC, in %), microhardness using a Vickers micro-indenter before (VHN dry) and after 24 hours of storage in ethanol (VHN EtOH), and flexural strength (in MPa) and flexural modulus (in GPa) using a three-point bend test. Each composite layer and an uncured layer were also stored for one week in a standard cell growth medium to generate conditioned media. Human dental pulp cells were then cultured for 24 hours with the latter and cell viability was measured using an MTS assay. A similar experiment was repeated with conditioned media produced in contact with uncured composites, with and without the addition of 4 mM NAC. The data were subjected to a Shapiro-Wilk test, then one-way ANOVA or Kruskal-Wallis test, followed either by Tukey’s test (inter-material comparison) or by Dunnett’s or Dunn’s test (comparison between layers relative to the upper one). The level of statistical significance was set at 0.05. Some materials (EverX, X-traF, VenusBF, X-traB) did not show any significant differences (p>0.05) for any of the properties considered between the intermediate layers compared to the upper one (considered as reference). Others displayed significant differences, at least for some properties, highlighting the value of combining various key mechanical and biological characterization methods when investigating the quality of cure in depth. Significant inter-material differences (p<0.05) were observed when comparing the properties of their upper layer, considered as “optimally” polymerized. Hence, one needs to consider the absolute property values, not only their relative evolution concerning layer thickness. Finally, the use of NAC appeared as beneficial to reduce the risk of harmful effects to dental pulp cells, especially in case of excessive thickness use, and may therefore be of potential interest as an additive to composites in the future.

PMID:35917249 | DOI:10.2341/21-084-L

Categories
Nevin Manimala Statistics

Does Prophylactic Replacement of Voice Prosthesis Make Sense? A Study to Predict Prosthesis Lifetime

Otolaryngol Head Neck Surg. 2022 Aug 2:1945998221116815. doi: 10.1177/01945998221116815. Online ahead of print.

ABSTRACT

OBJECTIVE: Voice prosthesis leakage significantly affects the quality of life of patients undergoing laryngectomy, causing insecurity and frequent unplanned hospital visits and costs. In this study, the concept of prophylactic voice prosthesis replacement was explored to prevent leakages.

STUDY DESIGN: Retrospective cohort study.

SETTING: Tertiary hospital.

METHODS: This study included all patients who underwent laryngectomy between 2000 and 2012 in the Netherlands Cancer Institute. Device lifetimes and voice prosthesis replacements of a retrospective cohort were used to calculate the number of needed voice prostheses per patient per year to prevent 70% of the leakages by prophylactic replacement. Various strategies for the timing of prophylactic replacement were considered: adaptive strategies based on the individual patient’s history of replacement and fixed strategies based on the results of patients with similar voice prosthesis or treatment characteristics.

RESULTS: Patients used a median 3.4 voice prostheses per year (range, 0.1-48.1). We found high inter- and intrapatient variability in device lifetime. When prophylactic replacement is applied, this would become a median 9.4 voice prostheses per year, which means replacement every 38 days, implying >6 additional voice prostheses per patient per year. The individual adaptive model showed that preventing 70% of the leakages was impossible for most patients and only a median 25% can be prevented. Monte-Carlo simulations showed that prophylactic replacement is not feasible due to the high coefficient of variation (SD/mean) in device lifetime.

CONCLUSION: Based on our simulations, prophylactic replacement of voice prostheses is not feasible due to high inter- and intrapatient variation in device lifetime.

PMID:35917180 | DOI:10.1177/01945998221116815

Categories
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

Categories
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