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Nevin Manimala Statistics

Did Medicaid slow declines in access to health care during the great recession?

Health Serv Res. 2021 Mar 3. doi: 10.1111/1475-6773.13645. Online ahead of print.

ABSTRACT

OBJECTIVE: We examine whether broadened access to Medicaid helped insulate households from declines in health coverage and health care access linked to the 2007-2009 Great Recession.

DATA SOURCE: 2004-2010 Behavioral Risk Factor Surveillance System (BRFSS).

STUDY DESIGN: Flexible difference-in-difference regressions were used to compare the impact of county-level unemployment on health care access in states with generous Medicaid eligibility guidelines versus states with restrictive guidelines.

DATA COLLECTION/EXTRACTION METHODS: Nonelderly adults (aged 19-64) in the BRFSS were linked to county unemployment rates from the Bureau of Labor Statistics’ Local Area Unemployment Statistics Program. We created a Medicaid generosity index by simulating the share of a nationally representative sample of adults that would be eligible for Medicaid under each state’s 2007 Medicaid guidelines using data from the 2007 Current Population Survey’s Annual Social and Economic Supplement.

PRINCIPAL FINDINGS: A percentage point (PPT) increase in the county unemployment rate was associated with a 1.3 PPT (95% CI: 0.9-1.6, P < .01) increase in the likelihood of being uninsured and a 0.86 PPT (95% CI: 0.6-1.1, P < .01) increase in unmet medical needs due to cost in states with restrictive Medicaid eligibility guidelines. Conversely, a one PPT increase in unemployment was associated with only a 0.64 PPT (P < .01) increase in uninsurance among states with the most generous eligibility guidelines. Among states in the fourth quartile of generosity (ie, most generous), rises in county-level unemployment were associated with a 0.68 PPT (P < .10) increase in unmet medical needs due to cost-a 21% smaller decrease relative to states with the most restrictive Medicaid eligibility guidelines.

CONCLUSIONS: Increased access to Medicaid during the Great Recession mitigated the effects of increased unemployment on the rate of unmet medical need, particularly for adults with limited income.

PMID:33660277 | DOI:10.1111/1475-6773.13645

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The power of modelling pulsatile profiles

J Pharmacokinet Pharmacodyn. 2021 Mar 3. doi: 10.1007/s10928-021-09743-2. Online ahead of print.

ABSTRACT

The quantitative description of individual observations in non-linear mixed effects models over time is complicated when the studied biomarker has a pulsatile release (e.g. insulin, growth hormone, luteinizing hormone). Unfortunately, standard non-linear mixed effects population pharmacodynamic models such as turnover and precursor response models (with or without a cosinor component) are unable to quantify these complex secretion profiles over time. In this study, the statistical power of standard statistical methodology such as 6 post-dose measurements or the area under the curve from 0 to 12 h post-dose on simulated dense concentration-time profiles of growth hormone was compared to a deconvolution-analysis-informed modelling approach in different simulated scenarios. The statistical power of the deconvolution-analysis-informed approach was determined with a Monte-Carlo Mapped Power analysis. Due to the high level of intra- and inter-individual variability in growth hormone concentrations over time, regardless of the simulated effect size, only the deconvolution-analysis informed approach reached a statistical power of more than 80% with a sample size of less than 200 subjects per cohort. Furthermore, the use of this deconvolution-analysis-informed modelling approach improved the description of the observations on an individual level and enabled the quantification of a drug effect to be used for subsequent clinical trial simulations.

PMID:33660229 | DOI:10.1007/s10928-021-09743-2

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Competence in metered-dose inhaler technique among healthcare workers of three general hospitals in Mexico: it is not good after all these years

Adv Respir Med. 2021;89(1):8-14. doi: 10.5603/ARM.a2021.0027.

ABSTRACT

INTRODUCTION: Inhaled medication is the cornerstone of pharmacological treatment for chronic respiratory diseases. Therefore, it is important to use a metered-dose inhaler (MDI) correctly to get the appropriate dosage and benefit from the drug. Health-care workers (HCW) are responsible for teaching the correct MDI technique. Unfortunately, numerous studies consistently show that HCW have poor MDI technique. This study aimed to evaluate the current knowledge of MDI technique in HCW working in three general hospitals.

MATERIAL AND METHODS: A hospital-based, cross-sectional descriptive study was conducted in three general hospitals in Aguascalientes, México. Three surveyors simultaneously scored through a 14 dichotomic questions list as bad, regular, good, and very good MDI technique. Data were analyzed with SPSS version 16. Statistical analyses were performed using chi-square test or unpaired t-tests. An analysis of one-way ANOVA was used for comparison of three independent general hospitals. Values of p < 0.05 were considered to indicate statistical significance.

RESULTS: A total of 244 HCWs were surveyed: 78.3% were nurses whereas 21.3% were physicians. The inter-observer concor-dance analysis among observers was 0.97. We observed that 32.4% (79) performed a bad technique, 51.6% (126) a regular technique, 13.5% (33) a good one, and 2.5% HCW (6) a very good technique. No difference between gender, labor category, schedule, service, age, seniority, and education degree between the three hospitals was observed. The most common mistakes were “insufficient expiration prior to activation of the device”, and “the distance the inhaler was placed for inhalation” (83 and 84% respectively).

CONCLUSION: We observed that a high percentage of HCW do not follow the MDI technique correctly, being this percentage even higher than the reported in other studies. These observations suggest the urgent need to establish frequent training programs for the correct use of MDI.

PMID:33660243 | DOI:10.5603/ARM.a2021.0027

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Efficacy of pulmonary rehabilitation for bronchiectasis and related factors: which patients should receive the most treatment?

Adv Respir Med. 2021;89(1):15-22. doi: 10.5603/ARM.a2021.0029.

ABSTRACT

INTRODUCTION: Pulmonary rehabilitation (PR) is an effective approach for patients with chronic pulmonary disease, and it is also recommended for patients with bronchiectasis. The aims of the current study were to evaluate the efficacy of a multidisciplinary PR program and identify factors associated with improvement in patients with bronchiectasis. Material and ethods: We obtained data from patients with bronchiectasis who completed our PR program which consisted of education and training regarding bronchial hygiene. Pulmonary function test results, body composition, exercise capacity, quality of life, and psychological status were assessed before and after the PR program.

RESULTS: We enrolled 130 patients in this retrospective study. Most patients had a history of pneumonia. The Medical Research Council (MRC) dyspnea scale, incremental shuttle walking test (ISWT), endurance shuttle walking test (ESWT), St. George’s Respiratory Questionnaire (SGRQ), Chronic Respiratory Questionnaire (CRQ), and Hospital Anxiety and Depression (HAD) scores statistically improved after the PR program (all p < 0.001). Improvements were similar regardless of sex, etiology, smoking sta-tus, or number of hospitalizations. Age was negatively correlated with ΔSGRQ (p = 0.024, r = -0.203). Baseline forced expiratory volume in 1s (FEV1) was positively correlated with ΔCRQ (p = 0.015, r = 0.213) and negatively correlated with Δanxiety (p = 0.014, r = -0.215). Baseline MRC was negatively correlated with ΔMRC (p < 0.001, r = -0.563) and ΔSGRQ (p < 0.001, r = -0.308). Baseline ISWT was negatively correlated with ΔISWT (p = 0.043, r = -0.176) and Δanxiety (p = 0.007, r = -0.237). Baseline SGRQ was negatively correlated with ΔMRC (p = 0.003, r = -0.267) and ΔSGRQ (p < 0.001, r = -0.648).

CONCLUSIONS: Our PR program is efficacious for patients with bronchiectasis regardless of sex, etiologic cause of bronchiectasis, concomitant chronic obstructive pulmonary disease, smoking status, and/or number of hospitalizations. Improvement varied among patients which highlights the need for more studies to determine which patients will benefit most from the program.

PMID:33660244 | DOI:10.5603/ARM.a2021.0029

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Nevin Manimala Statistics

Informal versus formal judgment of statistical models: The case of normality assumptions

Psychon Bull Rev. 2021 Mar 3. doi: 10.3758/s13423-021-01879-z. Online ahead of print.

ABSTRACT

Researchers sometimes use informal judgment for statistical model diagnostics and assumption checking. Informal judgment might seem more desirable than formal judgment because of a paradox: Formal hypothesis tests of assumptions appear to become less useful as sample size increases. We suggest that this paradox can be resolved by evaluating both formal and informal statistical judgment via a simplified signal detection framework. In 4 studies, we used this approach to compare informal judgments of normality diagnostic graphs (histograms, Q-Q plots, and P-P plots) to the performance of several formal tests (Shapiro-Wilk test, Kolmogorov-Smirnov test, etc.). Participants judged whether or not graphs of sample data came from a normal population (Experiments 1-2) or whether or not from a population close enough to normal for a parametric test to be more powerful than a nonparametric one (Experiments 3-4). Across all experiments, participants’ informal judgments showed lower discriminability than did formal hypothesis tests. This pattern occurred even after participants were given 400 training trials with feedback, a financial incentive, and ecologically valid distribution shapes. The discriminability advantage of formal normality tests led to slightly more powerful follow-up tests (parametric vs. nonparametric). Overall, the framework used here suggests that formal model diagnostics may be more desirable than informal ones.

PMID:33660213 | DOI:10.3758/s13423-021-01879-z

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Dupilumab treatment in atopic dermatitis patients in the Netherlands versus Japan: a comparative cohort study revealing a discrepancy in patient-reported outcome measures

Br J Dermatol. 2021 Mar 3. doi: 10.1111/bjd.19897. Online ahead of print.

ABSTRACT

BACKGROUND: Dupilumab was equally effective among all racial subgroups in clinical trials, but a direct comparison in daily practice is lacking.

OBJECTIVE: To investigate effectiveness of dupilumab in atopic dermatitis (AD) patients in the Netherlands versus Japan up to 80 weeks of treatment.

METHODS: A longitudinal comparative cohort study was conducted in AD patients who were treated with dupilumab in daily practice. We used linear mixed-effects models to determine changes in time.

RESULTS: We found statistically significant differences in sex, disease onset, BMI and therapeutic history between Dutch (n=208) and Japanese (n=153) patients. The baseline Eczema Area and Severity Index (EASI) score was higher in Japanese patients (23.8 v.s. 14.8), while baseline Patient-Reported Outcome Measures (PROMs) were higher in Dutch patients. EASI scores decreased quickly to a level indicating “mild disease” (EASI < 7), and remained low in both countries. However, PROMs showed different trajectories with better scores in Japan.

CONCLUSION: Dupilumab showed significant, comparable, and sustained improvement of EASI scores in Japanese and Dutch patients. However, we found striking differences in the effect on PROMs between the countries, with a better outcome in Japanese patients.

PMID:33657668 | DOI:10.1111/bjd.19897

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Regeneration of pulp-dentine complex-like tissue in a rat experimental model under an inflammatory microenvironment using high phosphorous-containing bioactive glasses

Int Endod J. 2021 Mar 3. doi: 10.1111/iej.13505. Online ahead of print.

ABSTRACT

AIM: To investigate the effects of a bioactive glass with a high proportion of phosphorus (BG-hP) on the repair and regeneration of dental pulps in rats under an inflammatory microenvironment.

METHODOLOGY: Human dental pulp cells (hDPCs) stimulated with 1 μg/mL lipopolysaccharide (LPS) were cocultured with 0.1 mg/mL BG-hP. Cell proliferation was detected by MTT assays. The expression of inflammation-related genes and odontogenic differentiation-related genes was determined by real-time PCR. Alizarin red staining was used to detect the formation of mineralized nodules. Coronal pulp tissues of rat molars were stimulated with 10 mg/mL LPS and then treated with BG-hP. The expression of inflammation-related genes in pulp tissue was determined by real-time PCR. Haematoxylin-eosin staining and Masson staining were performed to observe the inflammatory response and mineralized matrix formation, after subcutaneous implantation in nude mice, at 3 days and 4 weeks, respectively. Analysis of variance was performed to measure statistical significance (P < 0.05).

RESULTS: BG-hP significantly reduced expression of interleukin-6 (IL-6) and IL-8 and significantly upregulated the expression of IL-10, IL-4 and transforming growth factor-β1 of the LPS-stimulated hDPCs (P < 0.05). BG-hP significantly inhibited the initial cell number (P < 0.05), but the hDPCs stimulated by LPS and cocultured with BG-hP maintained the same proliferation rate as the untreated hDPCs. BG-hP significantly promoted the expression of dentine matrix protein-1 and dentine sialophosphoprotein and the mineralization capacity of the LPS-stimulated hDPCs (P < 0.05). Furthermore, BG-hP significantly downregulated the expression of Il-6 and reduced the inflammatory response of the LPS-stimulated pulp tissue 3 days after subcutaneous implantation (P < 0.05). Four weeks after subcutaneous implantation, BG-hP induced the formation of a continuous layer of dentine-like structure with dentinal tubules and polarizing odontoblast-like cells aligned along it in the LPS-stimulated pulp tissue.

CONCLUSION: The present preliminarily results demonstrated that the bioactive glass with a high proportion of phosphorus inhibited the inflammatory response and promoted the formation of a pulp-dentine complex in a rat experimental model. This study provides a foundation for the construction of materials with the dual functions of exerting anti-inflammatory effects and promoting tissue regeneration to meet the needs of dental pulp repair and regeneration.

PMID:33657647 | DOI:10.1111/iej.13505

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Predicting sentinel node positivity in melanoma patients: external validation of a risk-prediction calculator (the MIA nomogram) using a large European population-based patient cohort

Br J Dermatol. 2021 Mar 3. doi: 10.1111/bjd.19895. Online ahead of print.

ABSTRACT

BACKGROUND: A nomogram to predict SN-positivity (the Melanoma Institute Australia (MIA) nomogram) was recently developed and externally validated using two large single-institution databases. However, there remains a need to further validate the nomogram’s performance using population-based data.

OBJECTIVES: This study sought to address this using a European national patient cohort.

METHODS: Cutaneous melanoma patients who underwent SN biopsy in the Netherlands between 2000 and 2014 were included. Their data were obtained from the Dutch Pathology Registry (PALGA). The predictive performance of the nomogram was assessed by discrimination (C-statistic) and calibration. Negative predictive values (NPV) were calculated at various predicted probability cut-offs.

RESULTS: Of the 3049 patients who met the eligibility criteria, 23% (691) were SN-positive. Validation of the MIA nomogram (included parameters: Breslow thickness, ulceration, age, melanoma subtype and lymphovascular invasion) showed a good C-statistic of 0.69 (95% CI 0.66-0.71) with excellent calibration (R2 0.985, p=0.399). The NPV of 90.1%, found at a 10% predicted probability cut-off from having a positive SN biopsy, implied that by using the nomogram, a 16.3% reduction in the rate of performing a SN biopsy could be achieved with an error rate of 1.6%. Validation of the MIA nomogram considering mitotic rate as present/absent showed a C-statistic of 0.70 (95% CI 0.68-0.73).

CONCLUSIONS: This population-based validation study in European melanoma patients confirmed the value of the MIA nomogram in predicting SN-positivity. Its use will spare low-risk patients the inconvenience, cost and potential risks of SN biopsy while ensuring that high-risk patients are still identified.

PMID:33657653 | DOI:10.1111/bjd.19895

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Integrated molecular modeling techniques to reveal selective mechanisms of inhibitors to PI3Kδ with marketed Idelalisib

Chem Biol Drug Des. 2021 Mar 3. doi: 10.1111/cbdd.13838. Online ahead of print.

ABSTRACT

Phosphatidylinositol-3-kinase (PI3K) is important for cell proliferation, differentiation, and apoptosis, and the diverse physiological roles of different PI3K isoforms have highlighted the significance of the development of PI3Kδ inhibitors. A large number of PI3Kδ inhibitors have been reported after the FDA approval of Idelalisib, but the clinical use of Idelalisib was limited because of its serious side effects. Therefore, great efforts have been made on the development of PI3Kδ inhibitors with higher selectivity and lower toxicity, but there is no new PI3Kδ inhibitor coming into the market so far. Even so, as the first listed PI3K inhibitor, Idelalisib could be used as an effective tool to investigate the selective inhibition mechanism of PI3Kδ. Thus, in this study, a modeling strategy integrated 3D-QSAR, pharmacophore model and molecular dynamics simulation was employed to reveal the key chemical characteristics of Idelalisib analogs and the binding pattern between the inhibitors and PI3Kδ. First, the CoMFA model with high statistical significance was built to reveal the general structure activity relationships. And then, a reliable pharmacophore model with a robust discrimination capability was constructed to expound the main chemical characteristics of the PI3Kδ inhibitors. Finally, molecular dynamics simulation was conducted to explore the binding modes and some key residues refer to δ-selective binding were highlighted with binding free energy calculation. In summary, these models and results would provide some effective help for the discovery or the rational design of novel PI3Kδ inhibitors.

PMID:33657663 | DOI:10.1111/cbdd.13838

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Effects of patient decision aids in patients with type 2 diabetes mellitus: A systematic review and meta-analysis

Int J Nurs Pract. 2021 Mar 3:e12914. doi: 10.1111/ijn.12914. Online ahead of print.

ABSTRACT

AIMS: This study aimed to systematically evaluate the effectiveness of patient decision aids on knowledge, decisional conflict and decisional self-efficacy outcomes in patients with diabetes.

METHODS: A comprehensive database search was performed using the Web of Science, Cochrane Library, PubMed, Embase, PsycINFO (Ovid), CINAHL (EBASCO), CNKI, VIP, Wan Fang Database and the Ottawa Decision Aid Library Inventory (http://decisionaid.ohri.ca/index.html) from inception to 13 October 2019. Two reviewers independently searched databases, screened articles, extracted data and evaluated the risk bias of included studies. Then Rev Man 5.3 software was adopted for statistical analysis.

RESULTS: Ten articles containing 1,452 people with diabetes were selected. The results of meta-analysis showed that patient decision aids had a positive effect on reducing decisional conflict and improving decisional self-efficacy among patients with type 2 diabetes. Meanwhile, this article also revealed that patient decision aids have beneficial short-term effects on improving knowledge, but there was no significant long-term effect.

CONCLUSION: Patient decision aids are capable of becoming support tools to improve shared decision making. Further implementation studies are required to transform patient decision aids tools into clinical practice.

PMID:33657667 | DOI:10.1111/ijn.12914