Category: Statistics

Daru. 2021 Oct 31. doi: 10.1007/s40199-021-00424-6. Online ahead of print.

ABSTRACT

BACKGROUND AND PURPOSE: Fibrocystic disease (FCD) of the breast as a very common health problem in women has estrogen-dependent and proliferative features. No effective management strategy has been validated for this disorder, so far. The anti-hyperglycemic agent metformin has both anti-proliferative and estrogen-suppressing effects. Thus, we investigated metformin as a management strategy for FCD.

METHODS: The study was a double-blind placebo-controlled randomized clinical trial. Premenopausal women with FCD according to history, physical exam and ultrasound, who had measurable microcyst clusters on ultrasound (US) were entered the study. Oral placebo and metformin tablets (500 mg) were used twice daily by participants in the intervention and control groups. Size and number of microcyst clusters on US and the subjective pain score were recorded before and after the intervention.

RESULTS: 154 participants were randomly allocated into two groups of 77 interventions and 77 controls. The decrease in size of the largest microcyst cluster in each patient and the mean decrease in number of microcyst clusters were not statistically significant (P = 0.310 and P = 0.637, respectively). However, those microcyst clusters which were ≥ 14 mm became significantly smaller after metformin use (P = 0.006). Additionally, in the subset of participants with pain at baseline, a larger proportion in the intervention group experienced at least 50% reduction in pain score (63.8% (30/47) in the intervention vs. 44.2% (19/43) in the placebo groups, P = 0.031).

CONCLUSION: Our study showed that metformin might be effective in the management of FCD. Further studies are proposed for confirmation of this subject.

PMID:34719004 | DOI:10.1007/s40199-021-00424-6

Adv Ther. 2021 Oct 31. doi: 10.1007/s12325-021-01960-y. Online ahead of print.

ABSTRACT

INTRODUCTION: Atherosclerotic cardiovascular disease (ASCVD) is the leading cause of mortality in Italy, accounting for 22% of total deaths. Lowering low-density lipoprotein cholesterol (LDL-C) levels reduces the risk of cardiovascular (CV) events; thus, lipid-lowering therapy (LLT) is the first-line treatment for patients with ASCVD and hypercholesterolaemia. However, many patients with ASCVD fail to reach LDL-C treatment thresholds, leaving them at greater risk of CV events. Inpatient care accounts for 51% of total expenditure on cardiovascular disease in the European Union, but healthcare resource utilization (HCRU) data for ASCVD in Italy is limited.

METHODS: The study analysed healthcare claims data for 17,881 patients with acute coronary syndrome, ischemic stroke or peripheral artery disease from the Umbria 2 and Marche regions of Italy. LLT treatment patterns and CV event rates were collected and HCRU estimated in the year before and after the index event.

RESULTS: High-intensity LLTs were prescribed to 44.3% of patients and 49.6% received moderate-/low-intensity LLTs during the 6 months after the index event. The first year CV event rate was 18.0/100 patient-years for patients receiving high-intensity LLTs and 17.2/100 patient-years for those on moderate-/low-intensity LLTs. Higher costs were associated with patients untreated with LLT 6 months post-index event (€8323) than patients prescribed high-intensity (€6278) or moderate-/low-intensity LLTs (€6270). Hospitalization accounted for most of the total costs.

CONCLUSIONS: This study found that CV events in secondary prevention Italian patients are associated with substantial HCRU and costs. More intensive LDL-C lowering can prevent CV events, easing the financial burden on the healthcare system.

PMID:34718949 | DOI:10.1007/s12325-021-01960-y

Environ Sci Pollut Res Int. 2021 Oct 31. doi: 10.1007/s11356-021-17201-2. Online ahead of print.

ABSTRACT

The risk of the waterborne toxicity caused by herbicides threatens the aquatic environment. In this study, propolis nanoparticles were shown to relieve the impacts of glyphosate-induced oxidative stress and immunosuppression in Nile tilapia. The control group was fed a basal diet and maintained in a glyphosate-free water (control). Simultaneously, the other three groups were exposed to sublethal concentrations of glyphosate (0.6 mg/L) and fed diets containing 0 and 10 g propolis and 10 g propolis nanoparticles for 4 weeks. Nile tilapia exposed to glyphosate for 2 and 4 weeks exhibited a significant increase in serum alanine aminotransferase, aspartate aminotransferase, urea, and creatinine values compared to the control. After 2 and 4 weeks, fish exposed to glyphosate who were not fed propolis and propolis nanoparticles showed a significant reduction in total protein, albumin, and globulin levels, lysozyme activity, and total immunoglobulin levels. Nile tilapia exposed to glyphosate displayed a significant increase in blood glucose and cortisol concentrations after 2 and 4 weeks. Furthermore, liver and gill tissues from fish exposed to glyphosate exhibited a significant increase in malondialdehyde (MDA) concentrations. Conversely, a statistically significant decrease was observed in the liver and gill MDA levels and AChE activity of the groups treated with propolis and propolis nanoparticles compared to the groups exposed to glyphosate and fed the basal diet. Fish exposed to glyphosate for 2 and 4 weeks showed a significant decrease (p < 0.05) in hepatic and gill glutathione (GSH) concentration and white blood cell and red blood cell counts compared to the control group. Meanwhile, these parameters in groups fed propolis and propolis nanoparticles were markedly ameliorated compared to exposed fish fed the basal diet. Dietary supplementation of propolis nanoparticles is superior to supplementation of propolis in the normal form for protecting Nile tilapia from glyphosate toxicity.

PMID:34718976 | DOI:10.1007/s11356-021-17201-2

J Appl Genet. 2021 Oct 31. doi: 10.1007/s13353-021-00667-8. Online ahead of print.

ABSTRACT

A total of 96 different genotypes of upland cotton (Gossypium hirsutum) were selected from the breeding material and germplasm available at CCS HAU, India, to find the novel marker-trait associations for morphological traits used for registration of variety in upland cotton. Twenty-three morphological traits of the selected genotypes were recorded in field trials conducted in two replication of randomized block design during Kharif 2018 and 2019. A total of 11 traits showed sufficient variations in the screened germplasm and the same were further used for association mapping. A total of 168 SSRs were used for genotyping, of which 97 SSRs showed polymorphism amplifying 293 different alleles with an average of 3.02 alleles per SSR. Clustering, principal component analysis, and population structure analysis advocated that the current germplasm panel has enough diversity to be considered for association mapping. A total of 20 significant marker-trait associations were identified by the mixed linear model (MLM) and compressed mixed linear model (CMLM), of which 15 were common to both models, hence considered as promising associations. To the best of our knowledge, it is a first attempt to identify the linked markers in relation to morphological traits for the cotton crop. Results of the present study will be highly useful in speeding up variety registration programmes of upland cotton complementing to Distinctiveness, Uniformity, and Stability (DUS) testing.

PMID:34718944 | DOI:10.1007/s13353-021-00667-8

Ann Surg Oncol. 2021 Oct 30. doi: 10.1245/s10434-021-10945-8. Online ahead of print.

ABSTRACT

PURPOSE: Appendiceal cancer is a rare disease process with complex treatment strategies. The objective of this study was to identify mutation-based genetic subtypes that may differ from the current histological classification, compare the genetic make-up of primaries and metastases, and find novel targetable alterations.

METHODS: The analyses involved the curation and normalization of gene mutation panels from appendiceal adenocarcinoma and mucinous adenocarcinoma (n = 196) stored in the AACR GENIE Database v6.0. Genes mutated in less than one patient and tumors profiled with incomplete mutation panels were excluded from the study. The optimal number of AC subtypes was established using the Nonnegative Matrix Factorization algorithm. Statistical comparisons of mutation frequencies were performed using Pearson’s χ² test.

RESULTS: AC patients were stratified into five mutation subtypes, based on a final set of 41 cancer-related genes. AC0 had no mutations. The most frequently mutated genes varied between the subtypes were: AC1: KRAS (91.9%) and GNAS (77.4%); AC2: KRAS (52.5%), APC (32.5%), and GNAS (30%); AC3: KMT2D (38.7%), TP53 (38.7%), KRAS (35.5%), EP300 (22.6%); and AC4: TP53 (97.2%), KRAS (77.8%), and SMAD4 (36.1%). Additionally, AC3 was less likely to be mucinous (22.6% vs. 50.0-74.2%, p < 0.001) and had a higher mutation frequency (3.6 vs. 0-3.1, p < 0.001). There were no significant differences between primary tumors and metastases in the 41 assessed genes (p = 0.35).

CONCLUSIONS: The characterization of these subtypes suggests a need for molecular approaches to complement anatomical and histopathological staging for AC. A prospective comparison of subtype prognosis and response to surgery and adjuvant treatment is needed to identify the clinical applications of the novel molecular subtypes.

PMID:34718915 | DOI:10.1245/s10434-021-10945-8

Med Biol Eng Comput. 2021 Oct 30. doi: 10.1007/s11517-021-02461-4. Online ahead of print.

ABSTRACT

Electrocardiogram (ECG) indicates the occurrence of various cardiac diseases, and the accurate classification of ECG signals is important for the automatic diagnosis of arrhythmia. This paper presents a novel classification method based on multiple features by combining waveform morphology and frequency domain statistical analysis, which offer improved classification accuracy and minimise the time spent for classifying signals. A wavelet packet is used to decompose a denoised ECG signal, and the singular value, maximum value, and standard deviation of the decomposed wavelet packet coefficients are calculated to obtain the frequency domain feature space. The slope threshold method is applied to detect R peak and calculate RR intervals, and the first two RR intervals are extracted as time-domain features. The fusion feature space is composed of time and frequency domain features. A combination of support vector machine (SVM) with the help of grid search and waveform morphological analysis is applied to complete nine types of ECG signal classification. Computer simulations show that the accuracy of the proposed algorithm on multiple types of arrhythmia databases can reach 96.67%.

PMID:34718933 | DOI:10.1007/s11517-021-02461-4

J Patient Rep Outcomes. 2021 Oct 30;5(1):113. doi: 10.1186/s41687-021-00394-y.

ABSTRACT

BACKGROUND: English versions of the University of Washington Caregiver Stress (UW-CSS) and Benefit (UW-CBS) Scales were developed in the United States (US) to measure impact on caregivers of caring for a child/children. Caregiving stress and benefit are important constructs to study worldwide. The purpose of this study was to translate and validate the UW-CSS and UW-CBS into French, German, Italian, and Spanish languages.

METHOD: UW-CSS and UW-CBS were translated using forward and backward translation with reconciliation. Cognitive interviews (CIs) were completed with caregivers of children < 18 years with severe epilepsy. Translated versions were also administered to at least 100 caregivers in each of the four countries: France, Germany, Italy, and Spain. Differential item functioning (DIF) analyses were used to assess linguistic and cultural bias by country. The US development sample of 722 caregivers was used as a comparison sample for DIF analyses. DIF adjusted scores were calculated to determine impact of DIF on the item response theory (IRT)-based T-score. Benefit and stress scores were also calculated and compared across countries and health condition subgroups. Finally, short forms were modified to minimize the impact of DIF on the UW-CSS and UW-CBS T-scores and to reflect feedback from CIs.

RESULTS: Interviews were completed with 47 caregivers (German n = 14; Spanish n = 10; French n = 13; Italian n = 10). UW-CSS and UW-CBS were administered to 456 (German n = 117, Spanish n = 114, French n = 115, Italian n = 110) caregivers of children with and without health conditions. All stress items functioned well in CIs, though results indicated statistically significant DIF for three items in multiple countries and in the overall sample. Four of the 13 benefit items were problematic based on CI feedback, and six items showed DIF in one or more countries or in the combined sample. However, average differences between DIF adjusted and non-adjusted scores were minimal for both scales and all comparisons, indicating the impact of DIF on the total score was negligible.

CONCLUSION: Modified short forms functioned well in all four of the translated versions. All language versions are freely publicly available.

PMID:34718901 | DOI:10.1186/s41687-021-00394-y

Environ Monit Assess. 2021 Oct 30;193(11):757. doi: 10.1007/s10661-021-09554-5.

ABSTRACT

Taihu Lake Basin is highly developed but suffers from perennial water shortages due to pollution. Most studies have been limited to examining the water quality in specific areas, but few have investigated the entire basin. This study was based on official water quality data obtained from 565 sites in the monitoring network, thereby covering the entire basin. The water quality spatiotemporal variations were explored by statistical analysis, and the precise spatial distribution of the main pollutants was analyzed by heat maps. Only 29.09% of the water quality assessment results showed “drinkable,” whereas 28.63% showed “moderate” and “severe” pollution. The “severe” proportion had a significant declining trend (R² = 0.933) and was affected by the variations of nitrogen that was related to rainfall and anthropogenic activities. The water quality spatial variation was most likely related to anthropogenic influence and land use. The water quality in the developed and densely populated urban areas was poor, especially in downtown Shanghai. NH₃-N, TN, TP, BOD₅, COD, COD_Mn, and DO were the main pollutants that affected the water quality. NH₃-N and TN were major reduction targets. NH₃-N was the main pollutant that deteriorated the water quality in most densely populated urban areas. Many lakes and reservoirs were highly polluted with TN. Controlling domestic sewage may be effective to improve the water quality. This study makes up for the limited research on the water quality spatiotemporal variations in the entire Taihu Lake Basin and provides beneficial information and suggestions for decision-making regarding the water management.

PMID:34718911 | DOI:10.1007/s10661-021-09554-5

Seizure. 2021 Oct 20;93:81-87. doi: 10.1016/j.seizure.2021.10.009. Online ahead of print.

ABSTRACT

Since early 2020, an unprecedented public global health emergency caused by coronavirus (COVID-19) resulted in national governments’ imposing confinement measures. Lockdowns and isolation during pandemics complicate disease management and medication adherence. Chronic conditions, such as epilepsy, require linear adherence patterns to prevent breakthrough seizures and to reduce the risk of sudden unexpected death. Limited access to health care facilities for routine care and medicines management further hampers this. Social isolation exacerbates stress, depression and decreases social support, which may combine to reduce adherence to antiseizure medication (ASM) during the pandemic.

METHODS: We conducted a literature scoping review to explore ASM adherence among people with epilepsy, non-infected or infected SARS-CoV-2 or recovered from COVID-19 during the pandemic and explore risk factors for adherence. We search Pubmed for articles up to 16 September 2021. Search terms included the thematic of ASM adherence and COVID-19. We adhered to the PRISMA guidelines for reporting scoping reviews.

RESULTS: Six articles were retained after the screening, which covered four overarching themes: change of ASM compliance and as risk factors, lack of follow-up, difficulties accessing ASM, and behavioural risk factors. Our review underscores the lack of evidence on ASM adherence among people with epilepsy infected or recovered from COVID-19. No study retrieved took place in a low-income setting, warranting a cautionary approach to be employed when extrapolating findings on a global scale.

RECOMMENDATIONS FOR PRACTICE: Missing information on past SARS-CoV2 infections impact people with epilepsy precludes exploring a direct effect of SARS-CoV2 on ASM adherence. A more comprehensive chronic disease model based on the burden of co-cardiovascular and neuro-behavioural comorbidities should be envisaged for this population in preparation for future pandemics. A monitoring algorithm needs to be in place to establish a telemedicine framework and community pharmacists’ potential to contribute to the model recognised.

PMID:34717290 | DOI:10.1016/j.seizure.2021.10.009

Int J Nurs Stud. 2021 Sep 8;124:104088. doi: 10.1016/j.ijnurstu.2021.104088. Online ahead of print.

ABSTRACT

BACKGROUND: Food fortification as part of the food-first approach in nursing homes is a strategy that may increase energy and protein intake.

OBJECTIVES: This review aimed to determine the effect of nutrition interventions using fortification, nutrient-dense or enriched food and/or drinks on energy and protein intake in residents living in nursing homes, compared to the standard menu with or without oral nutritional support products. The secondary aim was to identify and synthesise outcomes of these interventions on weight change, nutritional status, acceptability, cost-effectiveness, and cost-benefit.

METHODS: A systematic search of seven databases was undertaken. After reviewing all titles/abstracts then full-text papers, key data were extracted and synthesised narratively and through meta-analysis. The quality of included studies was assessed using the Quality Criteria Checklist for Primary Research.

RESULTS: Of 3,098 articles retrieved, 16 were included, 13 in the meta-analysis. There were 891 participants, with the study duration ranging from four to 26 weeks. The groups receiving the fortified diet had a significantly higher energy intake (Hedges’ g = 0.69 (CI 0.36-1.03), p < 0.0001) and protein intake (Hedges’ g = 0.46 (CI 0.17-0.74), p = 0.003) compared with the groups receiving the standard menu +/- ONS. The meta-analysis revealed I² values of 77% for energy (p < 0.0001) and 60% for protein (p = 0.003), indicating considerable statistical heterogeneity across included studies. Benefits to weight and nutritional status of residents were recorded in some studies. Where reported, cost-effectiveness and cost-benefit of menu fortification/supplementation were variable.

CONCLUSIONS: This systematic review with meta-analyses has shown that fortified menus may significantly increase energy and protein intakes compared with standard menus in nursing homes. As such, the findings of this review support further use of fortified diets in this setting. Further research is warranted comparing food fortification to standard menus, with a particular focus on evaluating the effect on weight, nutritional status and cost-effectiveness of the intervention.

STUDY REGISTRATION: PROSPERO no. CRD42020162796.

PMID:34717275 | DOI:10.1016/j.ijnurstu.2021.104088