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Nevin Manimala Statistics

E-learning cultural competence for public health workers: A feasibility and pilot study

Public Health Nurs. 2021 May 21. doi: 10.1111/phn.12923. Online ahead of print.

ABSTRACT

OBJECTIVE: To describe the development, feasibility, and preliminary efficacy of a seven-module e-learning for enhancing cultural competence of public health workers.

DESIGN: The study was based on the framework of the new Medical Research Council; a mixed methods design was used.

SAMPLE: A four-week pilot cluster-randomized controlled trial was conducted with 39 public health workers and 74 migrants in South Korea. Feasibility and preliminary efficacy were assessed according to initiation, retention, adherence, usability, acceptability, individual and organizational cultural competence, and migrant trust and satisfaction. Quantitative data were collected at baseline, 4 weeks, and 12 weeks. Focus group interviews were conducted with eight public health workers at 12 weeks.

RESULTS: Initiation, retention, and adherence rates were high. Participants agreed on acceptability, but exhibited mixed results on usability. Participants were satisfied with “well-structured content,” “authentic case stories and videos,” “increased interest in migrant care,” and “opportunity for self-reflection.” However, “flawless and trouble-free system,” “screen design for easy navigation,” “instructor’s expertise,” and “more situational cases and videos” were desired. Statistically significant differences were observed for individual cultural competence, migrant trust, and satisfaction.

CONCLUSION: Generally, the intervention seems feasible and has preliminary efficacy, yet usability improvement is necessary for full-scale randomized controlled trials.

PMID:34019724 | DOI:10.1111/phn.12923

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Nevin Manimala Statistics

Evaluation of the prognostic role of NLR, LMR, PLR and LCR ratio in COVID-19 patients

J Med Virol. 2021 May 21. doi: 10.1002/jmv.27097. Online ahead of print.

ABSTRACT

We aimed to find the most useful biomarker by examining the prognostic effect of neutrophil-lymphocyte ratio (NLR), lymphocyte-monocyte ratio (LMR), platalet-lymphocyte ratio (PLR) and lymphocyte-C reactive protein ratio (LCR) in COVID-19 patients. 304 patients diagnosed with COVID-19 infection in our hospital within five months (April-August 2020) were examined. Laboratory values and demographic findings of the patients were analyzed retrospectively. 36 were diagnosed with severe cases. The ratio of NLR, LMR, PLR, and LCR of patients with severe and those non-severe clinic were statistically analyzed. The NLR and PLR ratios of those with severe clinic were significantly higher (p <0.001), the LCR rate was significantly lower (p <0.001), and there was no significant difference in the LMR rate (p = 0.199). When we examined other peripheral blood parameters, we found that CRP was high, lymphocyte and monocyte were low (p <0.001), but neutrophil (p = 0.416) and platelet (p = 0.998) were not statistically different between the groups. According to the results, routine blood values are abnormal in COVID-19 patients. NLR, PLR and LCR ratios can be used as more significant biomarkers than other values in predicting prognosis of patients. This article is protected by copyright. All rights reserved.

PMID:34019701 | DOI:10.1002/jmv.27097

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Nevin Manimala Statistics

The relationship between white matter microstructure, cardiovascular fitness, gross motor skills, and neurocognitive functioning in children

J Neurosci Res. 2021 May 21. doi: 10.1002/jnr.24851. Online ahead of print.

ABSTRACT

Recent evidence indicates that both cardiovascular fitness and gross motor skill performance are related to enhanced neurocognitive functioning in children by influencing brain structure and functioning. This study investigates the role of white matter microstructure in the relationship of both cardiovascular fitness and gross motor skills with neurocognitive functioning in healthy children. In total 92 children (mean age 9.1 years, range 8.0-10.7) were included in this study. Cardiovascular fitness and gross motor skill performance were assessed using performance-based tests. Neurocognitive functioning was assessed using computerized tests (working memory, inhibition, interference control, information processing, and attention). Diffusion tensor imaging was used in combination with tract-based spatial statistics to assess white matter microstructure as defined by fractional anisotropy (FA), axial and radial diffusivity (AD, RD). The results revealed positive associations of both cardiovascular fitness and gross motor skills with neurocognitive functioning. Information processing and motor response inhibition were associated with FA in a cluster located in the corpus callosum. Within this cluster, higher cardiovascular fitness and better gross motor skills were both associated with greater FA, greater AD, and lower RD. No mediating role was found for FA in the relationship of both cardiovascular fitness and gross motor skills with neurocognitive functioning. The results indicate that cardiovascular fitness and gross motor skills are related to neurocognitive functioning as well as white matter microstructure in children. However, this study provides no evidence for a mediating role of white matter microstructure in these relationships.

PMID:34019710 | DOI:10.1002/jnr.24851

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Nevin Manimala Statistics

In vitro and In silico Biopharmaceutic Regulatory Guidelines for Generic Bioequivalence for Oral Products; Comparison among various regulatory agencies

Biopharm Drug Dispos. 2021 May 21. doi: 10.1002/bdd.2292. Online ahead of print.

ABSTRACT

Generic drug development is a complex process that involves development of formulation similar to Reference Listed Drug (RLD). Because of the complexity associated with generic drug development, many regulatory agencies have come up with various guidelines. Out of many guidelines, the Biopharmaceutics classification system (BCS) that was introduced in 1995 based on aqueous solubility and permeability helped many pharmaceutical scientists across the globe to utilize the tool for formulation development, waiver of in vivo studies. Later on in vitro guidelines based on dissolution and IVIVC were introduced by many regulatory agencies with an intent to reduce number of in vivo human testing thereby facilitating shorter development time and faster approvals and launch. Most recently understanding the importance in silico approaches such as PBPK modelling, regulatory agencies such as USFDA and EMA came up with modelling guidance documents. Even though consensus exists between guidance documents from various regulatory agencies, still there are many minor to major differences exists between these guidance documents that needs to be considered while submitting a generic drug application. This review aims to compare all the in vitro and in silico guidance documents from major regulatory agencies with emphasis on latest trends and technologies combined with regulatory acceptability with an intention to harmonize regulations. Guidance documents from major regulatory agencies such as USFDA, EMA, WHO, ICH and other emerging markets were compared. Similarities &differences among these guidance documents are critically reviewed to provide the reader a detailed overview of these guidance documents at one place. This article is protected by copyright. All rights reserved.

PMID:34019712 | DOI:10.1002/bdd.2292

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Nevin Manimala Statistics

Maternal Depressive Symptoms, Sleep, and Odds of Spontaneous Early Birth: Implications for Racial Inequities in Birth Outcomes

Sleep. 2021 May 21:zsab133. doi: 10.1093/sleep/zsab133. Online ahead of print.

ABSTRACT

STUDY OBJECTIVES: Delivery prior to full term affects 37% of US births, including ~400,000 preterm births (<37 weeks) and >1,000,000 early term births (37-38 weeks). Approximately 70% of cases of shortened gestation are spontaneous – without medically-indicated cause. Elucidation of modifiable behavioral factors would have considerable clinical impact.

METHODS: This study examined the role of depressive symptoms and sleep quality in predicting the odds of spontaneous shortened gestation among 317 women (135 Black, 182 White) who completed psychosocial assessment in mid-pregnancy.

RESULTS: Adjusting for key covariates, Black women had 1.89 times higher odds of spontaneous shortened gestation compared to White women (OR (95% CI) = 1.89 (1.01, 3.53), p=0.046). Women who reported only poor subjective sleep quality (PSQI > 6) or only elevated depressive symptoms (CES-D ≥ 16) exhibited no statistically significant differences in odds of spontaneous shortened gestation compared to those with neither risk factor. However, women with comorbid poor sleep and depressive symptoms exhibited markedly higher odds of spontaneous shortened gestation than those with neither risk factor [39.2% versus 15.7%, [OR (95% CI) = 2.69 (1.27, 5.70), p = 0.01]. A higher proportion of Black women met criteria for both risk factors (23% of Black women versus 11% of White women; p=0.004), with a lower proportion experiencing neither risk factor (40.7% of Black versus 64.3% of White women; p < 0.001).

CONCLUSIONS: Additive effects of poor subjective sleep quality and depressive symptoms were observed with markedly higher odds of spontaneous shortened gestation among women with both risk factors. Racial inequities in rates of comorbid exposure corresponded with inequities in shortened gestation. Future empirical studies and intervention efforts should consider the interactive effects of these commonly co-morbid exposures.

PMID:34019675 | DOI:10.1093/sleep/zsab133

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Nevin Manimala Statistics

Improving Renal Tumor Biopsy Prognostication With BAP1 Analyses

Arch Pathol Lab Med. 2021 May 21. doi: 10.5858/arpa.2020-0413-OA. Online ahead of print.

ABSTRACT

CONTEXT.—: Active surveillance of small renal masses highlights the need for accurate prognostication of biopsies.

OBJECTIVE.—: To comprehensively evaluate the accuracy of biopsies in assessing known prognostic parameters including histologic subtype by comparison with subsequent nephrectomy samples.

DESIGN.—: We retrospectively identified patients at University of Texas Southwestern Medical Center, Dallas, Texas, who had a biopsy for a renal mass between 2004-2018. Biopsy samples were evaluated for known prognostic factors such as tumor grade, necrosis, sarcomatoid/rhabdoid change, and BRCA1-associated protein-1 (BAP1) status, which we previously showed is an independent prognostic factor for clear cell renal cell carcinoma. Accuracy was determined by comparison with subsequent analyses of nephrectomy specimens. Statistical analyses were performed to assess biopsy accuracy and correlation with tumor size and pathologic stage.

RESULTS.—: From 805 biopsies with a diagnosis of renal neoplasm, 178 had subsequent resection of the biopsied tumor. Concordance rate for histologic subtype was 96.9% (κ [w], 0.90; 95% CI, 0.82-0.99) and excellent for small renal masses (98.8%; κ [w], 0.97; 95% CI, 0.90-1). Amongst the prognostic variables evaluated, BAP1 immunohistochemistry in clear cell renal cell carcinoma had the highest agreement (94.8%; κ [w], 0.83; 95% CI, 0.66-0.99). The presence of 1 or more aggressive features (grade 3-4, tumor necrosis, BAP1 loss, sarcomatoid/rhabdoid change) in a biopsy significantly correlated with pT stage (P = .004).

CONCLUSIONS.—: Biopsy analyses showed high accuracy for subtyping renal tumors, but it underestimated several poor prognostic features. Addition of BAP1 for clear cell renal cell carcinoma may increase prognostic accuracy. If validated, routine incorporation of BAP1 immunohistochemistry in clear cell renal cell carcinoma biopsies may refine prognosis and aid in the selection of patients for active surveillance.

PMID:34019633 | DOI:10.5858/arpa.2020-0413-OA

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Nevin Manimala Statistics

Structure-Function Mapping Using a Three-Dimensional Neuroretinal Rim Parameter Derived From Spectral Domain Optical Coherence Tomography Volume Scans

Transl Vis Sci Technol. 2021 May 3;10(6):28. doi: 10.1167/tvst.10.6.28.

ABSTRACT

PURPOSE: To assess the structure-function relationship in glaucoma using Humphrey visual field (HVF) perimetry and a three-dimensional neuroretinal rim parameter derived from spectral domain optical coherence tomography (SD-OCT) volume scans.

METHODS: Structure-function correlation was analyzed globally and regionally (four quadrants and four sectors). Structural data included peripapillary retinal nerve fiber layer (RNFL) thickness and minimum distance band (MDB) neuroretinal rim thickness, defined as the shortest distance between the inner cup surface and the outer retinal pigment epithelium/Bruch’s membrane complex. Logarithmic regression analyses were performed and Pearson correlation coefficients determined to assess relationship strength.

RESULTS: The study consisted of 102 open-angle glaucoma patients and 58 healthy subjects. The Pearson correlation coefficient for global MDB thickness (R = 0.585) was higher than for global RNFL thickness (R = 0.492), but the difference was not statistically significant (P = 0.18). The correlation coefficients for regional MDB thicknesses and corresponding HVF sensitivities were higher than those for regional RNFL thicknesses and HVF in six out of eight regions (P = 0.08 to 0.47). In the remaining two out of eight regions, the correlation coefficients were higher for RNFL thickness than for MDB thickness (P = 0.15 to 0.20).

CONCLUSIONS: Three-dimensional MDB neuroretinal rim thickness relates to visual function as strongly as the most commonly used SD-OCT parameter for glaucoma, two-dimensional peripapillary RNFL thickness.

TRANSLATIONAL RELEVANCE: This paper illustrates the potential for 3D OCT algorithms to improve in vivo imaging in glaucoma.

PMID:34019635 | DOI:10.1167/tvst.10.6.28

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Nevin Manimala Statistics

RNAnue: efficient data analysis for RNA-RNA interactomics

Nucleic Acids Res. 2021 May 21:gkab340. doi: 10.1093/nar/gkab340. Online ahead of print.

ABSTRACT

RNA-RNA inter- and intramolecular interactions are fundamental for numerous biological processes. While there are reasonable approaches to map RNA secondary structures genome-wide, understanding how different RNAs interact to carry out their regulatory functions requires mapping of intermolecular base pairs. Recently, different strategies to detect RNA-RNA duplexes in living cells, so called direct duplex detection (DDD) methods, have been developed. Common to all is the Psoralen-mediated in vivo RNA crosslinking followed by RNA Proximity Ligation to join the two interacting RNA strands. Sequencing of the RNA via classical RNA-seq and subsequent specialised bioinformatic analyses the result in the prediction of inter- and intramolecular RNA-RNA interactions. Existing approaches adapt standard RNA-seq analysis pipelines, but often neglect inherent features of RNA-RNA interactions that are useful for filtering and statistical assessment. Here we present RNAnue, a general pipeline for the inference of RNA-RNA interactions from DDD experiments that takes into account hybridisation potential and statistical significance to improve prediction accuracy. We applied RNAnue to data from different DDD studies and compared our results to those of the original methods. This showed that RNAnue performs better in terms of quantity and quality of predictions.

PMID:34019662 | DOI:10.1093/nar/gkab340

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Nevin Manimala Statistics

Statistical methods versus machine learning techniques for donor-recipient matching in liver transplantation

PLoS One. 2021 May 21;16(5):e0252068. doi: 10.1371/journal.pone.0252068. eCollection 2021.

ABSTRACT

Donor-Recipient (D-R) matching is one of the main challenges to be fulfilled nowadays. Due to the increasing number of recipients and the small amount of donors in liver transplantation, the allocation method is crucial. In this paper, to establish a fair comparison, the United Network for Organ Sharing database was used with 4 different end-points (3 months, and 1, 2 and 5 years), with a total of 39, 189 D-R pairs and 28 donor and recipient variables. Modelling techniques were divided into two groups: 1) classical statistical methods, including Logistic Regression (LR) and Naïve Bayes (NB), and 2) standard machine learning techniques, including Multilayer Perceptron (MLP), Random Forest (RF), Gradient Boosting (GB) or Support Vector Machines (SVM), among others. The methods were compared with standard scores, MELD, SOFT and BAR. For the 5-years end-point, LR (AUC = 0.654) outperformed several machine learning techniques, such as MLP (AUC = 0.599), GB (AUC = 0.600), SVM (AUC = 0.624) or RF (AUC = 0.644), among others. Moreover, LR also outperformed standard scores. The same pattern was reproduced for the others 3 end-points. Complex machine learning methods were not able to improve the performance of liver allocation, probably due to the implicit limitations associated to the collection process of the database.

PMID:34019601 | DOI:10.1371/journal.pone.0252068

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Nevin Manimala Statistics

A Systematic Review and Meta-Analysis of Validation Studies Performed on Dietary Record Apps

Adv Nutr. 2021 May 21:nmab058. doi: 10.1093/advances/nmab058. Online ahead of print.

ABSTRACT

Mobile dietary record apps have been increasingly validated by studies with various study designs. This review aims to evaluate the overall accuracy of dietary record apps in measuring the intake of energy, macro- and micronutrients, and food groups in real-life settings and the designs of validation studies. We systematically searched mobile dietary record validation studies published during the period from 2013 to 2019. We identified 14 studies for the systematic review, of which 11 studies were suitable for meta-analyses on energy intake and 8 studies on macronutrient intake. Mean differences and SDs of nutrient estimations between the app and the reference method from studies were pooled using a random-effects model. All apps underestimated energy intake when compared with their reference methods, with a pooled effect of -202 kcal/d (95% CI: -319, -85 kcal/d); the heterogeneity of studies was 72%. After stratification, studies that used the same food-composition table for both the app and the reference method had a lower level of heterogeneity (0%) and a pooled effect of -57 kcal/d (95% CI: -116, 2 kcal/d). The heterogeneity of studies in the differences in carbohydrate, fat, and protein intake was 54%, 73%, and 80%, with the pooled effect of -18.8 g/d, -12.7 g/d, and -12.2 g/d, respectively, after excluding outliers. The intakes of micronutrients and food groups were statistically nonsignificantly underestimated by the apps in most cases. In conclusion, dietary record apps underestimated food consumption compared with traditional dietary assessment methods. Moreover, varying study designs have been found across studies. Recommended practices for conducting validation studies were formulated including considering biomarkers as the reference, testing in a larger and more representative study population for a longer period, avoiding the learning effect of each method, and comparing food group or food item consumption in addition to comparing energy and nutrient intakes.

PMID:34019624 | DOI:10.1093/advances/nmab058