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Nevin Manimala Statistics

Post-market, randomized, controlled, prospective study evaluating intrathecal pain medication versus conventional medical management in the non-cancer, refractory, chronic pain population (PROSPER)

Expert Rev Med Devices. 2022 Nov 28. doi: 10.1080/17434440.2022.2152673. Online ahead of print.

ABSTRACT

INTRODUCTION: Intrathecal therapy has been limited by no randomized prospective studies, particularly for those suffering from non-cancer. Further, no prospective, randomized studies investigating the efficacy, safety, and utilization of the intrathecal polyanalgesic consensus guidelines exist.

METHODS: After IRB approval, patients were enrolled in a 1:1 fashion for intrathecal drug delivery (IDD) or conventional management (CMM), employing standard of care, excluding intrathecal drug delivery, based on the principal investigator’s discretion. They were followed 3, 6, 9, and 12 months. Assessments included PROMIS 29, NPRS, and PriceMonkey.

RESULTS: 79 patients were screened, 54 patients were enrolled: 26 to IDD and 28 to CMM. At 3 months, there was no measurable difference in pain improvement in either subgroup within the CMM for chronic pain related syndromes (CPRS) or failed back and related spine disorders (FBRS). For the IDD, early and maintained benefit from baseline was statistically achieved. Cost analysis of pump to CMM breakeven was 4.5 months. There were no adverse events related to compounded intrathecal medications.

CONCLUSION: This is the first randomized prospective, multicenter study investigating the safety, cost, and efficacy of off-label medications for intrathecal therapy, as compared to conventional management, and suggests early detection of improvement, cost savings, safety of intrathecal compounded medication use, and safety and efficacy of employing the PACC guidance.

PMID:36440473 | DOI:10.1080/17434440.2022.2152673

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Identification of the Optimal Model for the Prediction of Diabetic Retinopathy in Chinese Rural Population: Handan Eye Study

J Diabetes Res. 2022 Nov 16;2022:4282953. doi: 10.1155/2022/4282953. eCollection 2022.

ABSTRACT

BACKGROUND: To identify an optimal model for diabetic retinopathy (DR) prediction in Chinese rural population by establishing and comparing different algorithms based on the data from Handan Eye Study (HES).

METHODS: Five algorithms, including multivariable logistic regression (MLR), classification and regression trees (C&RT), support vector machine (SVM), random forests (RF), and gradient boosting machine (GBM), were used to establish DR prediction models with HES data. The performance of the models was assessed based on the adjusted area under the ROC curve (AUROC), sensitivity, specificity, and accuracy.

RESULTS: The data on 4752 subjects were used to build the DR prediction model, and among them, 198 patients were diagnosed with DR. The age of the included subjects ranged from 30 to 85 years old, with an average age of 50.9 years (SD = 3.04). The kappa coefficient of the diagnosis between the two ophthalmologists was 0.857. The MLR model revealed that blood glucose, systolic blood pressure, and body mass index were independently associated with the development of DR. The AUROC obtained by GBM (0.952), RF (0.949), and MLR (0.936) was similar and statistically larger than that of CART (0.682) and SVM (0.765).

CONCLUSIONS: The MLR model exhibited excellent prediction performance and visible equation and thus was the optimal model for DR prediction. Therefore, the MLR model may have the potential to serve as a complementary screening tool for the early detection of DR, especially in remote and underserved areas.

PMID:36440469 | PMC:PMC9683953 | DOI:10.1155/2022/4282953

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The effect of asthma specialist intervention on asthma control among adults

World Allergy Organ J. 2022 Nov 17;15(11):100712. doi: 10.1016/j.waojou.2022.100712. eCollection 2022 Nov.

ABSTRACT

BACKGROUND: Various ways to improve asthma control have been studied, with only a modest effect.

PURPOSE: To evaluate the effect of asthma specialist visit on asthma control among adult asthma patients.

PATIENTS AND METHODS: This matched cohort study included patients ages 21-50 with asthma and at least 1 visit to an asthma specialist. Patients were compared to adult asthma patients treated only by primary care physicians. The study outcomes, included use of asthma medication, healthcare visits, and mortality. All outcomes were compared one year before and after specialist visit.

RESULTS: 4166 pairs were included in the study. In the study group, a statistically significant decrease in the average number of relievers (1.5 ± 3.2 vs. 1.17 ± 2.9, p < 0.001) and systemic steroids purchased (0.53 ± 1.2 vs. 0.4 ± 1.2, p < 0.001), with an increase in average number of inhaled steroid purchased (1.6 ± 2.5 vs. 2.3 ± 33, p < 0.001) was seen over time. A significant decrease in the average number of PCP visits (9.5 ± 7.2 vs. 8.9 ± 7.3, p < 0.001), emergency department (ED) visits (0.46 ± 1 vs. 0.4 ± 0.9, p = 0.05) and all-cause hospitalization (0.03 ± 0.22 vs. 0.01 ± 1.9, p < 0.001) was seen in the study group but not in controls. Generalized linear modeling demonstrated an overall significant effect of specialist intervention for all parameters (p < 0.01), except ED visits (p = 0.06). During follow-up, eight (0.2%) study group patients vs. 19 (0.5%) controls died (p = 0.03).

CONCLUSION: We found that asthma specialist intervention significantly improved asthma outcomes in adults. Referring adult asthma patients to an asthma specialist should be a goal of asthma management plans.

TRIAL REGISTRATION: Not relevant.

PMID:36440463 | PMC:PMC9674533 | DOI:10.1016/j.waojou.2022.100712

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Electronic medical record use and associated factors among healthcare professionals at public health facilities in Dire Dawa, eastern Ethiopia: A mixed-method study

Front Digit Health. 2022 Aug 23;4:935945. doi: 10.3389/fdgth.2022.935945. eCollection 2022.

ABSTRACT

BACKGROUND: Despite the significant benefits of digital health technologies (ITs), developing countries are lagging behind their developed counterparts in the adoption of electronic medical records (EMRs) in a healthcare setting. EMRs have long been considered essential elements in improving the quality of healthcare. However, the rate of utilization of EMRs among healthcare providers still remains low, particularly in developing countries.

OBJECTIVE: This study aimed at exploring EMR use and its determinants among healthcare providers at public health facilities in Dire Dawa, eastern Ethiopia.

METHODS: A quantitative cross-sectional study was conducted among 402 health professionals working at public health facilities supplemented with an exploratory qualitative study in Dire Dawa, Ethiopia. Descriptive summary statistics and binary and multivariable logistic regression analysis were used to explore the determinant factors of EMR use, while qualitative data were thematically analyzed.

RESULTS: Overall, about a quarter (26.6%) of health professionals were using electronic medical records. A work experience of 6 years or less [adjusted odds ratio (AOR) = 2.23; 95% confidence interval (CI): [1.15-4.31]], a discussion on EMR (AOR = 14.47; 95% CI: [5.58-7.57]), the presence of an EMR manual (AOR = 3.10; 95% CI: [1.28-7.38]), and a positive attitude toward the EMR system (AOR = 11.15; 95% CI: [4.90-25.36]) and service quality (AOR = 8.02; 95% CI: [4.09-15.72]) were independent determinants of EMR use. Poor collaboration among stakeholders and dependence on the software programs of NGOs were the main challenges cited by key informants.

CONCLUSION: The findings of this study indicate that EMR use by health professionals in the study area is very low. Several organizational, technical, and behavioral factors were identified for this low utilization. Therefore, there is a need to leverage EMRs through continuous technical support and commitment to enhance its use, which has the potential to improve health service performance. Developing locally applicable EMR software should be considered.

PMID:36440461 | PMC:PMC9697183 | DOI:10.3389/fdgth.2022.935945

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Generalized mean residual life models for survival data with missing censoring indicators

Stat Med. 2022 Nov 27. doi: 10.1002/sim.9615. Online ahead of print.

ABSTRACT

The mean residual life (MRL) function is an important and attractive alternative to the hazard function for characterizing the distribution of a time-to-event variable. In this article, we study the modeling and inference of a family of generalized MRL models for right-censored survival data with censoring indicators missing at random. To estimate the model parameters, augmented inverse probability weighted estimating equation approaches are developed, in which the non-missingness probability and the conditional probability of an uncensored observation are estimated by parametric methods or nonparametric kernel smoothing techniques. Asymptotic properties of the proposed estimators are established and finite sample performance is evaluated by extensive simulation studies. An application to brain cancer data is presented to illustrate the proposed methods.

PMID:36437483 | DOI:10.1002/sim.9615

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Comparison of machine learning methods with logistic regression analysis in creating predictive models for risk of critical in-hospital events in COVID-19 patients on hospital admission

BMC Med Inform Decis Mak. 2022 Nov 28;22(1):309. doi: 10.1186/s12911-022-02057-4.

ABSTRACT

BACKGROUND: Machine learning (ML) algorithms have been trained to early predict critical in-hospital events from COVID-19 using patient data at admission, but little is known on how their performance compares with each other and/or with statistical logistic regression (LR). This prospective multicentre cohort study compares the performance of a LR and five ML models on the contribution of influencing predictors and predictor-to-event relationships on prediction model´s performance.

METHODS: We used 25 baseline variables of 490 COVID-19 patients admitted to 8 hospitals in Germany (March-November 2020) to develop and validate (75/25 random-split) 3 linear (L1 and L2 penalty, elastic net [EN]) and 2 non-linear (support vector machine [SVM] with radial kernel, random forest [RF]) ML approaches for predicting critical events defined by intensive care unit transfer, invasive ventilation and/or death (composite end-point: 181 patients). Models were compared for performance (area-under-the-receiver-operating characteristic-curve [AUC], Brier score) and predictor importance (performance-loss metrics, partial-dependence profiles).

RESULTS: Models performed close with a small benefit for LR (utilizing restricted cubic splines for non-linearity) and RF (AUC means: 0.763-0.731 [RF-L1]); Brier scores: 0.184-0.197 [LR-L1]). Top ranked predictor variables (consistently highest importance: C-reactive protein) were largely identical across models, except creatinine, which exhibited marginal (L1, L2, EN, SVM) or high/non-linear effects (LR, RF) on events.

CONCLUSIONS: Although the LR and ML models analysed showed no strong differences in performance and the most influencing predictors for COVID-19-related event prediction, our results indicate a predictive benefit from taking account for non-linear predictor-to-event relationships and effects. Future efforts should focus on leveraging data-driven ML technologies from static towards dynamic modelling solutions that continuously learn and adapt to changes in data environments during the evolving pandemic.

TRIAL REGISTRATION NUMBER: NCT04659187.

PMID:36437469 | DOI:10.1186/s12911-022-02057-4

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Predicting moral intelligence in nursing students and its relationships with self-compassion, and cultural competence: a cross-sectional study

BMC Nurs. 2022 Nov 28;21(1):327. doi: 10.1186/s12912-022-01111-w.

ABSTRACT

BACKGROUND: In the recent era, nursing needs employees with moral intelligence, cultural competence, and self-compassion skills more than ever. This study aimed to determine the predictors of moral intelligence and its relationship with self-compassion and cultural competence in nursing students.

METHODS: This cross-sectional and multi-center descriptive study was conducted in 2022. With convenience sampling, 250 nursing students from three Iranian universities participated in this study. Data gathering included the Moral Intelligence Questionnaire, Self-Compassion Scale (short form), and Cultural Competency Questionnaire. The data were analyzed using descriptive statistics, the correlation between variables, and hierarchical regression.

RESULTS: The results showed that nursing students had good moral intelligence (72.63 ± 11.38), moderate self-compassion (37.19 ± 5.02), and poor cultural competence (50.06 ± 13.15). No statistically significant relationship was observed between self-compassion and cultural competence (r = 0.11, p = 0.07). Moral intelligence with marital status (r = 0.16, p = 0.01), academic year (r = 0.14, p = 0.03) and self-compassion (r = 0.33, p < 0.001) had a significant relationship in such a way that these variables explained 15% of moral intelligence and self-compassion had the highest impact (p < 0.001).

CONCLUSION: Considering the moderate level of self-compassion and the poor level of cultural competence reported in the undergraduate nursing students, and also that self-compassion was known to be a predictive factor for moral intelligence, planners and educators must pay more attention to promoting self-compassion and cultural competency in the curriculum and conduct studies to find ways to improve them.

PMID:36437448 | DOI:10.1186/s12912-022-01111-w

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Effects of Ozone Therapy on Chronic Arsenic Poisoning in Rats

Biol Trace Elem Res. 2022 Nov 28. doi: 10.1007/s12011-022-03486-y. Online ahead of print.

ABSTRACT

Arsenic (As) is a toxic metalloid that affects many organs through drinking water. This study aims to examine the efficacy of ozone therapy on chronic arsenic toxicity. Twenty-four male Wistar albino rats were housed in individual cages and grouped as control, As, O3, and As + O3. As was applied by adding 5 mg/kg/day in drinking water for 60 days. Ozone therapy was applied at 0.5 mg/kg/day (i.p.) O3 in the last 5 days of the experimental period. Tissues were harvested and analyzed for histopathological injury and apoptotic markers. There was no significant difference between the As + O3 and O3 groups (p = 0.186 and p = 0.599) for light microscopic criteria: inflammatory cell infiltration and hydropic degeneration in liver tissue.In TUNEL assessments, similar outcomes were obtained in the control and As + O3 groups. A statistically significant increase was observed in p53 and Caspase 3 (Casp-3) expression levels in the As group compared to the O3 and As + O3 groups. There was no significant difference between the As + O3 and O3 groups on peritubular hemorrhage and desquamation parameters in kidneys (p = 0.147 and p = 0.094). The KIM-1 expression level was significantly increased in the As group compared to the As + O3 group (p = 0.01), and the Casp-3 expression level was not significantly changed in the O3 group compared to the As + O3 group (p = 0.59). In conclusion, it is determined that ozone therapy has ameliorative effects on the microscopic injury of liver and kidney tissues. In addition to microscopic improvement, KIM-1 gene expression levels were ameliorated in the kidneys. The apoptotic cell counts and the Casp-3 and p53 gene expression levels were decreased by O3 administration. Thus, ozone therapy can be a treatment choice for As toxicity.

PMID:36437433 | DOI:10.1007/s12011-022-03486-y

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Oral health knowledge of Spanish breastfeeding mothers

Eur Arch Paediatr Dent. 2022 Nov 28. doi: 10.1007/s40368-022-00769-9. Online ahead of print.

ABSTRACT

INTRODUCTION: The aim of this study is to evaluate the knowledge of infant oral health in mothers who have breastfeeding for a period longer than 6 months.

METHODS: A descriptive, observational and cross-sectional study was carried out in 1126 mothers who had breastfed for more than 6 months, using a validated questionnaire.

RESULTS: 57% of the mothers surveyed had a high or very high level of knowledge about oral health during pregnancy and breastfeeding; a statistically significant association (p < 0.05) was found between this and the variables of mother’s age, duration of breastfeeding, level of education and previous information received about oral health.

CONCLUSIONS: The age of the mothers is positively related to the level of oral health knowledge, the elder the mothers the higher the knowledge. Mothers with a longer duration of breastfeeding beyond 24 months have a higher degree of oral health knowledge compared to the rest of the respondents, while their level of educations was also positively related to their degree of knowledge. There is a direct relationship between mothers having received previous information on oral hygiene and their surveyed degree of knowledge.

PMID:36437430 | DOI:10.1007/s40368-022-00769-9

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Safety and Immunogenicity of Inactivated SARS-CoV-2 Vaccine (BBIBP-CorV) in Hypertensive and/or Diabetic People Aged over 60 Years: A Prospective Open-Label Study

Diabetes Ther. 2022 Nov 27. doi: 10.1007/s13300-022-01343-8. Online ahead of print.

ABSTRACT

AIMS: Severe acute respiratory syndrome coronavirus type 2 (SARS-COV-2) infection may increase the risk of developing dangerous symptoms among the elderly with underlying medical conditions. The aim of this study was to evaluate the safety and immunogenicity of the SARS-CoV-2 inactivated vaccine (Vero) in patients over 60 years of age with hypertension and/or diabetes.

METHODS: An open-label, multi-center, prospective clinical trial was conducted at three medical sites in Fujian, China. Participants aged 60 years and above with hypertension, diabetes, and healthy controls were included in four groups: hypertension, diabetes, combined disease, and healthy controls. Volunteers received two doses of the inactivated SARS-COV-2 vaccine (BBIBP-CorV) on days 0 and 21. Adverse events were recorded for 21 days after each dose. Blood samples were taken before the first vaccination and 28 days after the second vaccination to detect the serum conversion rate and geometric mean titer (GMT) of neutralizing antibodies.

RESULTS: A total of 480 participants (110 hypertension, 110 diabetes, 100 combined hypertension and diabetes, and 160 healthy controls) were recruited. The incidences of adverse events in the four groups were 10 (9.1%) in the hypertension group, 19 (17.3%) in the diabetes group, 11 (11.0%) in the combined disease group, and 11 (6.9%) in healthy controls, with no statistical significance (P > 0.05). At 28 days after the second vaccination, the positive conversion rates of serum neutralizing antibody in the four groups were 97.3%(107/110), 97.3% (107/110), 100.0% (99/99),and 98.7%(155/157), respectively, and the GMTs were 75.28 (95% CI 64.03-88.50), 69.4 (95% CI 59-81.63), 77.21 (95% CI 66.68-89.41), and 78.64 (95% CI 69.87-88.50), respectively. There was no significant difference in neutralizing antibody responses among the four groups (P > 0.05). Additionally, the GMT after immunization was higher in females than in males (OR = 2.59, 95% CI 1.31-5.12).

CONCLUSIONS: The BBIBP-CorV vaccine is safe and elicits an adequate antibody response in patients over 60 years of age with hypertension and/or diabetes.

TRIAL REGISTRATION: ClinicalTrials.gov identifier, NCT05065879.

PMID:36437418 | DOI:10.1007/s13300-022-01343-8