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Nevin Manimala Statistics

Increasing ethnicity reporting to better understand cultural needs accessing a primary care talking therapy service

Behav Cogn Psychother. 2023 Jun 2:1-6. doi: 10.1017/S1352465823000176. Online ahead of print.

ABSTRACT

BACKGROUND: The COVID-19 pandemic highlighted the under-utilisation of statutory mental health care services by minority ethnic groups in the United Kingdom (UK).

AIM: To improve ethnicity reporting to better understand the needs of patients accessing a primary care talking therapies service.

METHOD: We conducted a clinical audit to observe outcomes from pre-COVID (2019), first wave of COVID-19 (2020) and 2021 for three broad ethnic categories: black African/Caribbean, Asian and white British. Intervention was conducted on staff to improve data recording of ethnicity. A patient survey was sent to those identified as dropped out from treatment from May 2020 to April 2021. A total of 229 patients responded to the survey. The survey asked for reasons that impacted on not continuing with sessions.

RESULTS: Quantitative analysis showed a statistically significant difference on discharge outcome between white British and black African/Caribbean (p=<0.0001), with black African/Caribbean patients most likely to drop out of treatment, and in 2020 the Asian population was below the recovery target of 50%. Qualitative analysis revealed therapist factors included lack of confidence in therapist and not being listened to, patient factors included neurodiversity, being unsure whether it would be helpful and confidentiality concerns, and service factors included being notified of discharge from the service, remote delivery of therapy, treatment options, and treatment materials.

DISCUSSIONS: Services must work towards improving service provision by capturing hidden disparities and socialising treatment to meet the needs of minority ethnic groups in the UK. The present study recommends culturally adapted treatment and co-producing therapy materials.

PMID:37264882 | DOI:10.1017/S1352465823000176

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Nevin Manimala Statistics

Assesment of specific T-cell immunity to SARS-CoV-2 virus antigens in COVID-19 reconvalescents

Vopr Virusol. 2023 Feb 7;67(6):527-537. doi: 10.36233/0507-4088-151.

ABSTRACT

INTRODUCTION: The development of the COVID-19 pandemic has stimulated the scientific research aimed at studying of the mechanisms of formation the immunity against SARS-CoV-2. Currently, there is a need to develop a domestic simple and cost-effective specific method suitable for monitoring of T-cell response against SARS-CoV-2 in reconvalescents and vaccinated individuals.

AIM: Development of a screening method for evaluation specific T-cell immunity against SARS-CoV-2.

MATERIALS AND METHODS: Total 40 individuals who had mild to moderate COVID-19 and 20 healthy volunteers who did not have a history of this disease were examined. The presence and levels of IgG and IgM antibodies to SARS-CoV-2 were identified in participants sera by ELISA using the diagnostic kits from JSC Vector-Best (Novosibirsk, Russian Federation). Antigenic stimulation of mononuclear cells was carried out on commercial plates with adsorbed whole-virion inactivated SARS-CoV-2 antigen (State Research Center of Virology and Biotechnology VECTOR Novosibirsk, Russian Federation). The concentration of IFN- was measured in ELISA using the test systems from JSC Vector-Best (Novosibirsk, Russian Federation). The immunophenotyping of lymphocytes was performed on a flow cytometer Cytomics FC500 (Beckman Coulter, USA). Statistical data processing was carried out using the Microsoft Excel and STATISTICA 10 software package.

RESULTS: Stimulation of mononuclear cells isolated from the peripheral blood with whole-virion inactivated SARS-CoV-2 antigen fixed at the bottom of the wells of a polystyrene plate showed a significantly higher median response in terms of IFN- production in 40 people who had history of COVID-19 compared to 20 healthy blood donors (172.1 [34.3575.1] pg/ml versus 15.4 [6.925.8] pg/ml, p 0.0001). There was no difference in median IFN- levels in supernatants collected from unstimulated mononuclear cells from COVID-19 reconvalescents and healthy donors (2.7 [0.411.4] pg/ml versus 0.8 [0.023.3] pg/ml, p 0.05). The overall sensitivity and specificity of this method were 73% (95% CI 5888%) and 100% (95% CI 100100%), respectively, at a cut-off of 50 pg/ml.

CONCLUSION: The developed method for assessment of the cellular immune response to SARS-CoV-2 can be used as a screening method for monitoring the T-cell response in a population against a new coronavirus infection in recovered people.

PMID:37264842 | DOI:10.36233/0507-4088-151

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Nevin Manimala Statistics

Psychometric Properties of the Spanish Version of the Iowa Infant Feeding Attitude Scale in Fathers

J Hum Lact. 2023 Jun 2:8903344231175870. doi: 10.1177/08903344231175870. Online ahead of print.

ABSTRACT

BACKGROUND: Research gaps exist with regard to paternal attitudes towards breastfeeding and the association between fathers’ attitudes and the type of breastfeeding.

RESEARCH AIMS: (1): To analyze the psychometric properties of the Spanish version of the Iowa Infant Feeding Attitude Scale in fathers, and (2) to examine the association between fathers’ attitudes and type of breastfeeding.

METHOD: We used a cross-sectional study design to analyze the scale’s psychometric properties and performance.

RESULTS: A total of 639 fathers participated in the study. The mean age was 35.83 years (SD = 4.65) and 67.3% (n = 430) were married or in a civil partnership. We observed an adequate fit in the confirmatory factor analysis: TLI = 0.96, CFI = 0.97 and RMSEA = 0.05. The overall internal consistency was 0.76. Between 1-6 months, 48% (n = 307) of participants’ babies were exclusively breastfed, 35.2% (n = 225) were partially breastfed, and 16.7% (n = 107) were exclusively formula fed. Statistically significant differences were shown in attitudes towards breastfeeding, depending on the type of breastfeeding, between 1 and 6 months (F = 54.67; p < .001). Fathers who reported that their baby had been exclusively breastfed scored higher on attitudes towards breastfeeding. Statistically significant differences were also found between partial breastfeeding and formula feeding.

CONCLUSIONS: The Spanish version of the Iowa Infant Feeding Attitude Scale is a valid and reliable instrument for measuring paternal attitudes towards breastfeeding.

PMID:37264803 | DOI:10.1177/08903344231175870

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Evaluating potential predictors of weight loss response to liraglutide in adolescents with obesity: A post hoc analysis of the randomized, placebo-controlled SCALE Teens trial

Pediatr Obes. 2023 Jun 1:e13061. doi: 10.1111/ijpo.13061. Online ahead of print.

ABSTRACT

BACKGROUND: As childhood obesity prevalence increases, determining which patients respond to anti-obesity medications would strengthen personalized approaches to obesity treatment. In the SCALE Teens trial among pubertal adolescents with obesity (NCT02918279), liraglutide 3.0 mg (or maximum tolerated dose) significantly reduced body mass index (BMI) standard deviation score on average versus placebo. That said, liraglutide effects on BMI reduction varied greatly among adolescents, similar to adults.

OBJECTIVES: To identify post hoc characteristics predictive of achieving ≥5% and ≥10% BMI reductions at 56 weeks with liraglutide versus placebo in adolescents from the SCALE Teens trial.

METHODS: Logistic regression analysis was performed in 251 adolescents treated with liraglutide (n = 125) or placebo (n = 126) for 56 weeks. Baseline characteristics (selected a priori) included sex, race, ethnicity, age, Tanner (pubertal) stage, glycemic status (hyperglycemia [type 2 diabetes/prediabetes] vs. normoglycemia), obesity category (Class II/III vs. I), severity of depression symptoms (Patient Health Questionnaire-9), and weight variability (weight fluctuations over time). The effects of early responder status (≥4% BMI reduction at week 16) on week 56 response were assessed using descriptive statistics.

RESULTS: Baseline characteristics did not affect achievement of ≥5% and ≥10% BMI reductions at week 56 in adolescents treated with liraglutide. Further, there was no association between weight variability and BMI reduction. Early liraglutide responders appeared to have greater BMI and body weight reductions at week 56 compared with early non-responders.

CONCLUSIONS: This secondary analysis suggests that adolescents with obesity may experience significant BMI reductions after 56 weeks of liraglutide treatment, regardless of their sex, race, ethnicity, age, pubertal stage, glycemic status, obesity category, severity of depression symptoms, or weight variability. Early response may predict greater week 56 response.

PMID:37264767 | DOI:10.1111/ijpo.13061

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Cardiopulmonary exercise testing predicts prognosis in amyloid cardiomyopathy: a systematic review and meta-analysis

ESC Heart Fail. 2023 Jun 1. doi: 10.1002/ehf2.14406. Online ahead of print.

ABSTRACT

BACKGROUND: The clinical value of cardiopulmonary exercise testing (CPET) in cardiac amyloidosis (CA) is uncertain. Due to the growing prevalence of the disease and the current availability of disease-modifying drugs, prognostic stratification is becoming fundamental to optimizing the cost-effectiveness of treatment, patient phenotyping, follow-up, and management. Peak VO2 and VE/VCO2 slope are currently the most studied CPET variables in clinical settings, and both demonstrate substantial, independent prognostic value in several cardiovascular diseases. We aim to study the association of peak VO2 and VE/VCO2 slope with prognosis in patients with CA.

METHODS AND RESULTS: We performed a systematic review and searched for clinical studies performing CPET for prognostication in patients with transthyretin-CA and light-chain-CA. Studies reporting hazard ratio (HR) for mortality and peak VO2 or VE/VCO2 slope were further selected for quantitative analysis. HRs were pooled using a random-effect model. Five studies were selected for qualitative and three for quantitative analysis. A total of 233 patients were included in the meta-analysis. Mean peak VO2 resulted consistently depressed, and VE/VCO2 slope was increased. Our pooled analysis showed peak VO2 (pooled HR 0.89, 95% CI 0.84-0.94) and VE/VCO2 slope (pooled HR 1.04, 95% CI 1.01-1.07) were significantly associated with the risk of death in CA patients, with no significant statistical heterogeneity for both analyses.

CONCLUSIONS: CPET is a valuable tool for prognostic stratification in CA, identifying patients at increased risk of death. Large prospective clinical trials are needed to confirm this exploratory finding.

PMID:37264762 | DOI:10.1002/ehf2.14406

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Nevin Manimala Statistics

Genetic and lifestyle factors for breast cancer risk assessment in Southeast China

Cancer Med. 2023 Jun 2. doi: 10.1002/cam4.6198. Online ahead of print.

ABSTRACT

BACKGROUND: Despite the rising incidence and mortality of breast cancer among women in China, there are currently few predictive models for breast cancer in the Chinese population and with low accuracy. This study aimed to identify major genetic and life-style risk factors in a Chinese population for potential application in risk assessment models.

METHODS: A case-control study in southeast China was conducted including 1321 breast cancer patients and 2045 controls during 2013-2016, in which the data were randomly divided into a training set and a test set on a 7:3 scale. The association between genetic and life-style factors and breast cancer was examined using logistic regression models. Using AUC curves, we also compared the performance of the logistic model to machine learning models, namely LASSO regression model and support vector machine (SVM), and the scores calculated from CKB, Gail and Tyrer-Cuzick models in the test set.

RESULTS: Among all factors considered, the best model was achieved when polygenetic risk score, lifestyle, and reproductive factors were considered jointly in the logistic regression model (AUC = 0.73; 95% CI: 0.70-0.77). The models created in this study performed better than those using scores calculated from the CKB, Gail, and Tyrer-Cuzick models. However, the logistic model and machine learning models did not significantly differ from one another.

CONCLUSION: In summary, we have found genetic and lifestyle risk predictors for breast cancer with moderate discrimination, which might provide reference for breast cancer screening in southeast China. Further population-based studies are needed to validate the model for future applications in personalized breast cancer screening programs.

PMID:37264741 | DOI:10.1002/cam4.6198

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Renal tubular damage and clinical outcome in heart failure with preserved ejection fraction and chronic kidney disease

ESC Heart Fail. 2023 Jun 1. doi: 10.1002/ehf2.14378. Online ahead of print.

ABSTRACT

AIMS: Despite advances in heart failure (HF) treatment, HF with preserved ejection fraction (HFpEF) remains a health problem with a high mortality rate. HFpEF is composed of diverse phenogroups, of which patients with concomitant renal impairment have worse outcomes. Renal tubular damage (RTD) is associated with the development of HF and chronic kidney disease (CKD). However, the impact of RTD on HF progression in patients with HFpEF and CKD remains unclear. The aim of the present study was to examine whether RTD could predict HF-related events in patients with HFpEF and CKD.

METHODS AND RESULTS: We measured RTD markers, such as urinary β2 -microglobulin to creatinine ratio (UBCR) and N-acetyl-β-d-glucosamidase (NAG) level, in 319 consecutive patients with HFpEF and CKD who were hospitalized for acute HF (49% females, mean age 76 ± 12). Based on previous reports, high UBCR and high NAG levels were defined as UBCR ≥300 μg/gCr and NAG >14.2 U/gCr, respectively. There were 91 HF-related events, defined as HF hospitalizations or HF deaths, during the median follow-up period of 5.2 years. The prevalence of high UBCR increased with advancing New York Heart Association functional class and albuminuria. Kaplan-Meier analysis demonstrated that patients with high UBCR had more HF-related events than those with normal or low UBCR. Multivariate Cox proportional hazards regression analyses demonstrated that high UBCR, but not high NAG level, was an independent predictor of HF-related events after adjusting for confounding risk factors in patients with HFpEF and CKD (hazard ratio, 2.60; 95% confidence interval, 1.52-4.72; P = 0.0009). UBCR significantly improved the C-statistic, with a significant net reclassification index and integrated discrimination improvement (0.738 vs. 0.684; P = 0.0244).

CONCLUSION: RTD, as assessed by a high UBCR, was associated with the severity and clinical outcomes of HFpEF and CKD, indicating that it could be a feasible marker for HF progression.

PMID:37264723 | DOI:10.1002/ehf2.14378

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SARS-CoV-2 IgG Spike antibody levels and avidity in natural infection or following vaccination with mRNA-1273 or BNT162b2 vaccines

Hum Vaccin Immunother. 2023 Jun 1:2215677. doi: 10.1080/21645515.2023.2215677. Online ahead of print.

ABSTRACT

Certain aspects of the immunogenicity and effectiveness of the messenger ribonucleic acid (mRNA) vaccines (mRNA-1273 and BNT162b2) developed in response to the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic are still uncharacterized. Serum or plasma samples from healthy donor recipients of either vaccine (BNT162b2 n = 53, mRNA-1273 n = 49; age 23-67), and individuals naturally infected with SARS-CoV-2 (n = 106; age 18-82) were collected 0-2 months post-infection or 1- and 4 months after second dose of vaccination. Anti-Spike antibody levels and avidity were measured via an enzyme-linked immunosorbent assay (ELISA). Overall, vaccination induced higher circulating anti-Spike protein immunoglobulin G (IgG) antibody levels and avidity compared to infection at similar time intervals. Both vaccines produced similar anti-Spike IgG concentrations at 1 month, while mRNA-1273 demonstrated significantly higher circulating antibody concentrations after 4 months. mRNA-1273 induced significantly higher avidity at month 1 compared to BNT162b2 across all age groups. However, the 23-34 age group was the only group to maintain statistical significance by 4 months. Male BNT162b2 recipients were approaching statistically significant lower anti-Spike IgG avidity compared to females by month 4. These findings demonstrate enhanced anti-Spike IgG levels and avidity following vaccination compared to natural infection. In addition, the mRNA-1273 vaccine induced higher antibody levels by 4 months compared to BNT162b2.

PMID:37264688 | DOI:10.1080/21645515.2023.2215677

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Nevin Manimala Statistics

Evaluating the correlations of cost and utility parameters from summary statistics for probabilistic analysis in economic evaluations

Expert Rev Pharmacoecon Outcomes Res. 2023 Jun 1. doi: 10.1080/14737167.2023.2221436. Online ahead of print.

ABSTRACT

OBJECTIVES: The correlations between economic modeling input parameters directly impact the variance, and may impact the expected values of model outputs. However, correlation coefficients are not often reported in literature. We aim to understand the correlations between model inputs for probabilistic analysis from summary statistics.

METHODS: We provide proof that for correlated random variables X and Y (e.g. inpatient visits and outpatient visits), the Pearson correlation coefficients of sample means and samples are equal to each other (corr(X,Y)=corr(X¯,Y¯)). Therefore, when studies report summary statistics of correlated parameters, we can quantify the correlation coefficient between parameters.

RESULTS: We use examples to illustrate how to estimate the correlation coefficient between the incidence rates of non-severe and severe hypoglycemia events, and the common coefficient of five cost components for patients with diabetic foot ulcers. We further introduce three types of correlations for utilities and provide two examples to estimate the correlations for utilities based on published data. We also evaluate how correlations between cost parameters and utility parameters impact the cost-effectiveness results using a Markov model for major depression.

CONCLUSION: Incorporation of the correlations can improve the precision of cost-effectiveness results and increase confidence in evidence-based decision-making. Further empirical evidence is warranted.

PMID:37264680 | DOI:10.1080/14737167.2023.2221436

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Improving 10-year cardiovascular risk prediction in apparently healthy people: flexible addition of risk modifiers on top of SCORE2

Eur J Prev Cardiol. 2023 Jun 2:zwad187. doi: 10.1093/eurjpc/zwad187. Online ahead of print.

ABSTRACT

BACKGROUND: In clinical practice, factors associated with cardiovascular disease (CVD) like albuminuria, education level, or coronary artery calcium are often known, but not incorporated in cardiovascular risk prediction models. The aims of the current study were to evaluate a methodology for the flexible addition of risk modifying characteristics on top of SCORE2 and to quantify the added value of several clinically relevant risk modifying characteristics.

METHODS AND RESULTS: Individuals without previous CVD or DM were included from the UK Biobank, ARIC, MESA, EPIC-NL and HNR studies (n=409,757) in whom 16,166 CVD events and 19,149 non-cardiovascular deaths were observed over exactly 10.0 years of follow-up. The effect of each possible risk modifying characteristic was derived using competing risk-adjusted Fine and Gray models. The risk modifying characteristics were applied to individual predictions with a flexible method using the population prevalence and the subdistribution hazard ratio (SHR) of the relevant. Risk modifying characteristics that increased discrimination most were CAC percentile with 0.0198 (95%CI 0.0115; 0.0281) and hs-Troponin-T with 0.0100 (95%CI 0.0063; 0.0137). External validation was performed in the CPRD cohort (UK, n = 518,015, 12,675 CVD events). Adjustment of SCORE2 predicted risks with both single and multiple risk modifiers did not negatively affect calibration and led to a modest increase in discrimination (0.740 (95%CI 0.736-0.745) versus unimproved SCORE2 risk C-index 0.737 [95%CI 0.732-0.741]).

CONCLUSIONS: The current paper presents a method on how to integrate possible risk modifying characteristics that are not included in existing CVD risk models for the prediction of CVD event risk in apparently healthy people. This flexible methodology improves the accuracy of predicted risks and increases applicability of prediction models for individuals with additional risk known modifiers.

PMID:37264679 | DOI:10.1093/eurjpc/zwad187