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Nevin Manimala Statistics

Magnesium alginate versus proton pump inhibitors for the treatment of laryngopharyngeal reflux: a non-inferiority randomized controlled trial

Eur Arch Otorhinolaryngol. 2022 Jan 15. doi: 10.1007/s00405-021-07219-0. Online ahead of print.

ABSTRACT

PURPOSE: Proton pump inhibitors (PPIs) are commonly prescribed for laryngopharyngeal reflux (LPR), but their efficacy remains debated. Alginates is an option for the treatment of LPR with few adverse effects. The study aimed to investigate the non-inferiority of an alginate suspension (Gastrotuss®) compared to PPIs (Omeprazole) in reducing LPR symptoms and signs.

METHODS: A non-inferiority randomized controlled trial was conducted. Fifty patients with laryngopharyngeal symptoms (Reflux Symptom Index -RSI- ≥ 13) and signs (Reflux Finding Score -RFS- ≥ 7) were randomized in two treatment groups: (A) Gastrotuss® (20 ml, three daily doses) and, (B) Omeprazole (20 mg, once daily). The RSI and the RFS were assessed at baseline and after 2 months of treatment.

RESULTS: Groups had similar RSI and RFS scores at baseline. From pre- to 2-month posttreatment, the mean RSI significantly decreased (p = 0.001) in alginate and PPI group (p = 0.003). The difference between groups in the RSI change was not significant (95%CI: – 4.2-6.7, p = 0.639). The mean RFS significantly decreased in alginate (p = 0.006) and PPI groups (p = 0.006). The difference between groups in the mean change RFS was not significant (95%CI: – 0.8; 1.4, p = 0.608).

CONCLUSION: After 2 months of treatment, LPR symptoms and signs are significantly reduced irrespective of the treatment. Alginate was non-inferior to PPIs and may represent an alternative treatment to PPIs for the treatment of LPR.

PMID:35032204 | DOI:10.1007/s00405-021-07219-0

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Nevin Manimala Statistics

Cardiovascular risk prediction in type 2 diabetes: a comparison of 22 risk scores in primary care settings

Diabetologia. 2022 Jan 15. doi: 10.1007/s00125-021-05640-y. Online ahead of print.

ABSTRACT

AIMS/HYPOTHESIS: We aimed to compare the performance of risk prediction scores for CVD (i.e., coronary heart disease and stroke), and a broader definition of CVD including atrial fibrillation and heart failure (CVD+), in individuals with type 2 diabetes.

METHODS: Scores were identified through a literature review and were included irrespective of the type of predicted cardiovascular outcome or the inclusion of individuals with type 2 diabetes. Performance was assessed in a contemporary, representative sample of 168,871 UK-based individuals with type 2 diabetes (age ≥18 years without pre-existing CVD+). Missing observations were addressed using multiple imputation.

RESULTS: We evaluated 22 scores: 13 derived in the general population and nine in individuals with type 2 diabetes. The Systemic Coronary Risk Evaluation (SCORE) CVD rule derived in the general population performed best for both CVD (C statistic 0.67 [95% CI 0.67, 0.67]) and CVD+ (C statistic 0.69 [95% CI 0.69, 0.70]). The C statistic of the remaining scores ranged from 0.62 to 0.67 for CVD, and from 0.64 to 0.69 for CVD+. Calibration slopes (1 indicates perfect calibration) ranged from 0.38 (95% CI 0.37, 0.39) to 0.74 (95% CI 0.72, 0.76) for CVD, and from 0.41 (95% CI 0.40, 0.42) to 0.88 (95% CI 0.86, 0.90) for CVD+. A simple recalibration process considerably improved the performance of the scores, with calibration slopes now ranging between 0.96 and 1.04 for CVD. Scores with more predictors did not outperform scores with fewer predictors: for CVD+, QRISK3 (19 variables) had a C statistic of 0.68 (95% CI 0.68, 0.69), compared with SCORE CVD (six variables) which had a C statistic of 0.69 (95% CI 0.69, 0.70). Scores specific to individuals with diabetes did not discriminate better than scores derived in the general population: the UK Prospective Diabetes Study (UKPDS) scores performed significantly worse than SCORE CVD (p value <0.001).

CONCLUSIONS/INTERPRETATION: CVD risk prediction scores could not accurately identify individuals with type 2 diabetes who experienced a CVD event in the 10 years of follow-up. All 22 evaluated models had a comparable and modest discriminative ability.

PMID:35032176 | DOI:10.1007/s00125-021-05640-y

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Nevin Manimala Statistics

Assessment of Anti-Xa activity in patients receiving concomitant apixaban with strong p-glycoprotein inhibitors and statins

J Clin Pharm Ther. 2022 Jan 15. doi: 10.1111/jcpt.13596. Online ahead of print.

ABSTRACT

WHAT IS KNOWN AND OBJECTIVES: Although the apixaban Food and Drug Administration (FDA) package insert recommends dose reduction in patients administered dual strong inhibitors of p-glycoprotein (P-gp) and cytochrome P-450 (CYP) 3A4, there are limited published data regarding potential drug-drug interactions between apixaban (Eliquis) and common p-glycoprotein (P-gp) and CYP3A4 inhibitors co-administered with statins. The aim of this study was to investigate the degree of elevation relative to apixaban serum peak and trough concentration after the co-administration of amiodarone, diltiazem and statins (atorvastatin, rosuvastatin and simvastatin).

METHODS: Patients prescribed apixaban 5mg twice daily for at least one week were identified from the anticoagulation clinic database and contacted for potential enrolment. A total of 117 volunteers were enrolled with eight excluded due to discontinued use, resulting in 109 volunteers (44 females and 65 males delineated into age groups 40-64 and ≥65 years old) completing the observational study. Fifty-five volunteers were administered apixaban without the P-gp inhibitors amiodarone or diltiazem, with or without statins (atorvastatin, rosuvastatin and simvastatin). Fifty-four volunteers were administered apixaban with either amiodarone or diltiazem, with or without statins (atorvastatin, rosuvastatin or simvastatin). Peak and trough concentrations were assessed for each patient utilizing an apixaban anti-Xa assay.

RESULTS: Of the combinations studied, the mean apixaban trough concentration upon co-administration of amiodarone without a statin was elevated compared to apixaban alone (experimental 156.83 +/- 79.59 ng/ml vs. control 104.09 +/- 44.56 ng/ml; p = 0.04). The co-administration of diltiazem and rosuvastatin, and the administration of amiodarone without a statin led to greater than 1.5-fold increase in apixaban concentrations (peak experimental 315.19 +/- 157.53 ng/ml vs control 207.6 +/- 83.38 ng/ml; p = 0.08 and trough experimental 182.03 +/- 95.93 ng/ml vs control 112.32 +/- 37.78 ng/ml; p = 0.17) suggesting the need to assess dose adjustment for patients per the FDA package insert. In addition, the aggregated mean peak (p = 0.0056) and trough (p = 0.0089) elevation of CYP3A4 experimental groups (atorvastatin and simvastatin) co-administered apixaban and diltiazem were statistically significant compared with the aggregated non-CYP3A4 control groups (no statin and rosuvastatin).

WHAT IS NEW AND CONCLUSION: Herein, we report novel data regarding peak and trough apixaban concentrations after concomitant administration of P-gp and CYP3A4 inhibitors (amiodarone or diltiazem) co-administered with statins (atorvastatin, rosuvastatin or simvastatin). Providers should consider utilizing the apixaban anti-Xa assay or comparative heparin anti-Xa assay to determine if patients require dose reduction to decrease adverse events in high-risk patients prescribed apixaban and concomitant p-glycoprotein and CYP3A4 inhibitors amiodarone or diltiazem with and without a CYP3A4 or non-3A4 statin.

PMID:35032137 | DOI:10.1111/jcpt.13596

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Nevin Manimala Statistics

Obstetrical mode of delivery and behavioural outcomes in childhood and adolescence: findings from the Millennium Cohort Study

Soc Psychiatry Psychiatr Epidemiol. 2022 Jan 15. doi: 10.1007/s00127-022-02233-x. Online ahead of print.

ABSTRACT

PURPOSE: To examine the association between mode of delivery (in particular caesarean section) and behavioural outcomes in offspring at six time-points between age 3 and 17 years.

METHODS: Similar to previous work examining the association between mode of delivery and behavioural outcomes in offspring at age 7, we used maternal-reported data from the Millennium Cohort Study. Data on mode of delivery were collected when children were 9 months and categorised as spontaneous vaginal delivery, assisted vaginal delivery, induced vaginal delivery, emergency caesarean section, planned caesarean section and caesarean section after induction of labor. Data on behavioural outcomes were collected at ages 3, 5, 7, 11, 14 and 17 years using the Strengths and Difficulties Questionnaire (SDQ). Crude and adjusted logistic regression examined mode of delivery-behavioural difficulties relationship, using validated SDQ cut-off points (total SDQ ≥ 17, emotional ≥ 5, conduct ≥ 4, hyperactivity ≥ 7, peer problems ≥ 4 and prosocial behaviour ≤ 4). Multilevel models with linear splines examined the association between mode of delivery and repeated measures of SDQ.

RESULTS: There were 18,213 singleton mother-child pairs included at baseline, 13,600 at age 3; 13,831 at age 5; 12,687 at age 7; 11,055 at age 11; 10,745 at age 14 and 8839 at age 17. Adjusted logistic regression suggested few associations between mode of delivery and behavioural outcomes at ages 3, 5, 11, 14 and 17 years using validated SDQ cut-off points. After correction for multiple testing, only the protective association between planned caesarean section-Conduct difficulties at age 5 years (OR 0.63, 95% CI 0.46, 0.85) and positive association between caesarean section after induction-Emotional difficulties at age 11 years (OR 1.57, 95% CI 1.19, 2.07) remained statistically significant. Multilevel modelling suggested mean SDQ scores were similar in each mode of delivery group at each time point.

CONCLUSIONS: Results of this study indicate that mode of delivery is unlikely to have a major impact on behavioural outcomes.

PMID:35032173 | DOI:10.1007/s00127-022-02233-x

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Nevin Manimala Statistics

Prediction of recurrence by metabolites and expression of TOP2A and EZH2 in prostate cancer patients treated with radiotherapy

NMR Biomed. 2022 Jan 14:e4694. doi: 10.1002/nbm.4694. Online ahead of print.

ABSTRACT

BACKGROUND: The dual up-regulation of TOP2A and EZH2 gene expression has been proposed as a biomarker for recurrence in prostate cancer patients to be treated with radical prostatectomy. Low tissue level of the metabolite citrate has additionally been connected to aggressive disease and recurrence in this patient group. However, for radiotherapy prostate cancer patients, few prognostic biomarkers have been suggested. The main aim of this study was to use an integrated tissue analyses to evaluate metabolites and expression of TOP2A and EZH2 as predictors for recurrence among radiotherapy patients.

METHODS: From 90 prostate cancer patients (56 received neoadjuvant hormonal treatment), 172 transrectal ultrasound-guided (TRUS)-biopsies were collected prior to radiotherapy. Metabolic profiles were acquired from fresh frozen TRUS-biopsies using high resolution-magic angle spinning (HR-MAS) MR spectroscopy. Histopathology and immunohistochemistry staining for TOP2A and EZH2 were performed on TRUS-biopsies containing cancer cells (n=65) from 46 patients, where 24 of these patients (n=31 samples) received hormonal treatment. Eleven radical prostatectomy cohorts of a total of 2059 patients were used for validation in a meta-analysis.

RESULTS: Among radiotherapy patients with up to 11 years of follow-up, low level of citrate was found to predict recurrence, p=0.001 (C-index=0.74). Citrate had a higher predictive ability compared to individual clinical variables, highlighting its strength as a potential biomarker for recurrence. The dual up-regulation of TOP2A and EZH2 was suggested as a biomarker for recurrence, particularly for patients not receiving neoadjuvant hormonal treatment, p=0.001 (C-index=0.84). While citrate was a statistically significant biomarker independent on hormonal treatment status, the current study indicated a potential of glutamine, glutamate and choline as biomarkers for recurrence among patients receiving neoadjuvant hormonal treatment, and glucose among patients not receiving neoadjuvant hormonal treatment.

CONCLUSION: Using an integrated approach, our study shows the potential of citrate and the dual up-regulation of TOP2A and EZH2 as biomarkers for recurrence among radiotherapy patients.

PMID:35032074 | DOI:10.1002/nbm.4694

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Nevin Manimala Statistics

Navigating a Pandemic: A Qualitative Study of Knowledge, Sources of Information, and COVID-19-Related Precautions Taken by HBCU Students

J Racial Ethn Health Disparities. 2022 Jan 15. doi: 10.1007/s40615-021-01210-5. Online ahead of print.

ABSTRACT

The coronavirus (COVID-19) has spread quickly across the nation with a disproportionate impact on Black Americans. Many college-aged students receive their COVID-19-related information through social media and television even though research suggests that social media sources are more likely to be incorrect. Some students report trusting these sources over government sources such as the CDC and WHO. The purpose of this study was to understand Historically Black College and University (HBCU) students’ COVID-19 knowledge, sources of information, and planned precautions. There were 21 in-depth interviews conducted with students attending a large southern HBCU during Spring 2020. Themes regarding knowledge included the following: it is a flu-like condition, it has international roots, there is inaccurate and changing information, and it is a pandemic. Themes regarding sources included: the news, US government and related officials, social media, interactions with family, and other social interactions. Themes regarding severity included the following: statistics, a distrust for hospital reporting, a belief that COVID-19 deaths were conflated with baseline health, peer influence, and familial influence. Themes regarding precautions included the following: proper mask use, hand washing/ sanitizing, avoiding large crowds/small crowds only, physical distancing, COVID-19 testing/symptom monitoring, and COVID-19 vaccination.

PMID:35032009 | DOI:10.1007/s40615-021-01210-5

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Nevin Manimala Statistics

Relationship between the ApoB/ApoA-I ratio trajectory and risk of type 2 diabetes in China: a retrospective cohort study

Endocrine. 2022 Jan 15. doi: 10.1007/s12020-021-02961-1. Online ahead of print.

ABSTRACT

PURPOSE: Little research has investigated the correlation of changes in long-term apolipoprotein B/apolipoprotein A-I (ApoB/ApoA-I) ratio with risk of new-onset type 2 diabetes (T2D) among ordinary people. Therefore, the research took long-term ApoB/ApoA-I ratio trajectories as independent variables for exploring their association with the risk of newly diagnosed T2D.

METHODS: Altogether 5362 non-diabetic participants with a median age of 49 were enrolled in the cohort study. Their ApoB/ApoA-I ratio trajectories from 2016 to 2019 were analyzed and grouped using group-based trajectory modeling. The Kaplan-Meier approach was employed for calculating the newly diagnosed T2D-related incidence with different ApoB/ApoA-I ratio trajectories. A log-rank test was conducted for testing the presence of statistical difference in new-onset T2D incidence among the different ApoB/ApoA-I ratio trajectory groups. A multivariate Cox proportional hazards regression model was adopted for analyzing how ApoB/ApoA-I ratio trajectory changes affected new-onset T2D.

RESULTS: From 2016 to 2019, 199 patients developed T2D (3% in 3 years). The incidence of T2D was 2.0%, 3.28%, 5.86%, and 6.92% for low, middle, upper, and high ApoB/ApoA-I ratio trajectories, respectively. Following adjustment of underlying confounding factors, in contrast to low ApoB/ApoA-I ratio trajectory, new-onset T2D risk ratios and hazard ratio (HR) (95% confidence intervals [CI]) for the middle lower ApoB/ApoA-I ratio trajectory, and upper middle and high ApoB/ApoA-I ratio trajectories were [HR (95% CI)] 1.35(0.88-2.08), 1.98(1.27-3.09) and 2.42(1.35-4.34), respectively, indicating high and statistically significant risks of T2D.

CONCLUSION: Variations of the ApoB/ApoA-I ratio trajectory exerted independent effects on the 3-year incidence of T2D. Long-term monitoring on the ApoB/ApoA-I ratio locus may help improve the identification on patients with T2D.

PMID:35032012 | DOI:10.1007/s12020-021-02961-1

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Nevin Manimala Statistics

A novel model for prediction of stability constants of the thiosemicarbazone ligands with different types of toxic heavy metal ions using structural parameters and multivariate linear regression method

Environ Sci Pollut Res Int. 2022 Jan 15. doi: 10.1007/s11356-021-17714-w. Online ahead of print.

ABSTRACT

A novel model is presented for reliable estimation of the stability constants of the thiosemicarbazone ligands with different types of toxic heavy metal ions (log β11) in an aqueous solution, which has wide usage in environmental safety and ecotoxicology applications. The biggest reported data of log β11 for 120 metalthiosemicarbazone complexes are used for deriving and testing the novel model. In contrast to available methods where they need the two-dimensional (2D) and three-dimensional (3D) complex molecular descriptors as well as expert users and computer codes, the novel correlation uses four additive and two non-additive structural parameters of thiosemicarbazone ligands. The calculated results of the novel correlation are compared with the outputs of the genetic algorithm with multivariate linear regression method (GA-MLR) as one of the best existing methods, which requires seven complex descriptors. The estimated results for 78 of training as well as 42 of two different test sets were established by external and internal validations. The values of statistical parameters comprising average deviation, average absolute deviation, average absolute relative deviation, absolute maximum deviation, and the coefficient of determination for 73 data of training set of New model/GA-MLR are 0.04/ – 0.25, 1.06/1.31, 14.4/18.7, 3.18/7.92, and 0.830/0.652, respectively. Thus, the predicted results of the new model are worthy as compared to the complex GA-MLR model. Moreover, assessments of various statistical parameters confirm that the new model provides great reliability, goodness-of-fit, accuracy, and precision.

PMID:35031996 | DOI:10.1007/s11356-021-17714-w

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Nevin Manimala Statistics

Rotation in Correspondence Analysis from the Canonical Correlation Perspective

Psychometrika. 2022 Jan 15. doi: 10.1007/s11336-021-09833-7. Online ahead of print.

ABSTRACT

Correspondence analysis (CA) is a statistical method for depicting the relationship between two categorical variables, and usually places an emphasis on graphical representations. In this study, we discuss a CA formulation based on canonical correlation analysis (CCA). In CCA-based formulation, the correlations within and between row/column categories in a reduced dimensional space can be expressed by canonical variables. However, in existing CCA-based formulations, only orthogonal rotation is permitted. Herein, we propose an alternative CCA-based formulation that permits oblique rotation. In the proposed formulation, the CA loss function can be defined as maximizing the generalized coefficient of determination, which is a measure of proximity between two variables. Simulation studies and real data examples are presented in order to demonstrate the benefits of the proposed formulation.

PMID:35031941 | DOI:10.1007/s11336-021-09833-7

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Nevin Manimala Statistics

Evolution and growth of the ECHO (Enriching Communication skills for Health professionals in Oncofertility) program: a 5-year study in the training of oncofertility professionals

J Cancer Surviv. 2022 Jan 15. doi: 10.1007/s11764-021-01139-y. Online ahead of print.

ABSTRACT

PURPOSE: AYAs with cancer have unique psychosocial needs, with reproductive health being a primary concern. The ECHO training program provides reproductive health communication training to individuals providing care for AYAs with cancer. The purpose of this project is to describe the growth of ECHO and evaluate changes in learner engagement over a 5-year period.

METHODS: ECHO is an 8-week online training program offered annually, with the program including learning modules, discussion topics and reflections, and synchronous discussions. Reflection quality scores and number of words were compared between the 5 cohorts using ANOVA with a p < .05 level of significance. Descriptive statistics summarized module topics, reflections, and synchronous discussions.

RESULTS: The average number of reflections per unique learner increased each year (1.4 in cohort 1 vs 4.1 in cohort 5), as did average length and quality of reflections (72.1 words in cohort 1 vs 203.4 words in cohort 5, p < .0001; score of 1.21 in cohort 1 vs 4.46 in cohort 5, p < .0001). The percentage of learners in attendance at synchronous discussions increased between cohorts 4 and 5 (4.8% of learners in cohort 4 vs 18.8% of learners cohort 5).

CONCLUSIONS: The ECHO program has seen significant growth and improvement in learner engagement over a 5-year period. This is particularly important given that student learning outcomes in online courses can be predicted by the level of engagement with online content.

IMPLICATIONS FOR CANCER SURVIVORS: As fertility and reproductive health remain a top life goal and discussion priority for AYAs surviving cancer, increasing clinical competencies of AHPs in oncofertility is essential.

PMID:35031917 | DOI:10.1007/s11764-021-01139-y