Category: Statistics

Bioelectrochemistry. 2021 Oct 26;143:107987. doi: 10.1016/j.bioelechem.2021.107987. Online ahead of print.

ABSTRACT

Electroporation is a well-established technique used to stimulate cells, enhancing membrane permeability by inducing reversible membrane pores. In the absence of experimental observation of the dynamics of pore creation, molecular dynamics studies provide the molecular-level evidence that the electric field promotes pore formation. Although single steps in the pore formation process are well assessed, a kinetic model representing the mathematical description of the electroporation process, is lacking. In the present work we studied the basis of the pore formation process, providing a rationale for the definition of a first-order kinetic scheme. Here, authors propose a three-state kinetic model for the process based on the assessed mechanism of water defects intruding at the water/lipid interface, when applying electric field intensities at the edge of the linear regime. The methodology proposed is based on the use of two robust biophysical quantities analyzed for the water molecules intruding at the water/lipid interface: (i) number of hydrogen bonds; (ii) number of contacts. The final model, sustained by a robust statistical sampling, provides kinetic constants for the transitions from the intact bilayer state to the hydrophobic pore state.

PMID:34794113 | DOI:10.1016/j.bioelechem.2021.107987

Value Health Reg Issues. 2021 Nov 15;28:1-6. doi: 10.1016/j.vhri.2021.02.005. Online ahead of print.

ABSTRACT

BACKGROUND: Gynecological cancers (GCs) are an important cause of morbidity and mortality among women worldwide. The incidence of cancer is increasing in Iran, and according to statistics, it has become the most important cause of mortality. This study aimed to assess the economic burden of GCs, including cervical, ovarian, and endometrial cancers, in Iran in 2014.

METHODS: We used a prevalence-based cost of illness methodology to investigate the annual healthcare cost of GCs and to determine the productivity loss. The productivity loss was estimated, using the human capital approach. We obtained our data from a referral hospital for the year 2014; we also used expert opinion and occupational and statistical data. To estimate direct medical cost, we used bottom-up approach and we estimated the average cost of each procedure, multiplied by the number of patients receiving the procedure.

RESULTS: The total cost of GCs in Iran was estimated at $51 million in 2014. The direct costs were $32 million, and indirect costs were $19 million of the total annual cost. The total cost of ovarian cancer was the highest among 3 cancers.

CONCLUSIONS: Knowing that the cost of GCs has a significant impact on the burden of disease and imposes an economic burden on the country could force policy makers to allocate their resource in the prevention programs and new approach in patient’s management. This could lead to diagnose more GCs in the early stages, reduce mortality, and increase the quality of life.

PMID:34794064 | DOI:10.1016/j.vhri.2021.02.005

Ecotoxicol Environ Saf. 2021 Nov 15;228:112973. doi: 10.1016/j.ecoenv.2021.112973. Online ahead of print.

ABSTRACT

Wastewater contains a wealth of information about the inhabitants of cities. Wastewater-based epidemiology (WBE) has become an effective tool for monitoring public health by analyzing various biomarkers (e.g., chemicals and microorganisms) in wastewater. This way, the estimation of pharmaceuticals’ consumption behavior and/or illicit drugs can be calculated. However, monitoring consumption alone is not the only option. If we consider wastewater as a statistical representation of the population’s health, medical information can be derived. In this work, we used data from 15 different wastewater treatment plants in Slovak Republic to explore correlations between the use of typical pharmaceuticals and illicit drugs. The analysis was based on the wastewater monitoring data from four years (2016-2019), and 68 different compounds were taken into account. One of the strongest correlations found was between Antihyperlipidemics and Antihypertensives, with Pearson’s correlation coefficient of 0.82. This type of analysis within the WBE represents a new potential as an additional source of information for the pharmaceutical, medical and government sectors in assessing health risk factors in the population. Such an evaluation method has even a great potential for artificial intelligence and machine learning for calculating health risk factors together with other sources of data.

PMID:34794023 | DOI:10.1016/j.ecoenv.2021.112973

Clin Neurol Neurosurg. 2021 Oct 30;211:107014. doi: 10.1016/j.clineuro.2021.107014. Online ahead of print.

ABSTRACT

BACKGROUND: Operculoinsular cortectomy is increasingly recognized as a therapeutic avenue for perisylvian refractory epilepsy. However, most neurosurgeons are reluctant to perform this type of procedure because of feared neurological complications, especially in the language-dominant hemisphere, as the insula is involved in speech and language processes. The goal of this retrospective study is to quantify the incidence and types of speech and language deficits associated with operculoinsulectomies in the dominant hemisphere for language, and to identify factors associated with these complications.

METHODS: Clinical, imaging, and surgical data of all patients who had an operculoinsulectomy for refractory epilepsy at our center between 1998 and 2018 were reviewed. Language lateralization was determined by functional magnetic resonance imaging (fMRI) and/or Wada test. Speech and language assessments were carried out by neurosurgeons, neurologists, neuropsychologists and/or speech language pathologists, before surgery, during the first week after surgery, and at least 6 months after surgery.

RESULTS: Amongst 44 operculoinsulectomies, 13 were performed in the language-dominant hemisphere. 46% of these patients presented with transient aphasia post-surgery. However, a few months later, the patients’ performances on language assessments were not statistically different from before surgery, thus suggesting a complete recovery of speech and language functions.

CONCLUSION: Temporary aphasias after operculoinsulectomy for refractory epilepsy in the language-dominant hemisphere are frequent, but eventually subside. Potential mechanisms underlying this recovery are discussed.

PMID:34794058 | DOI:10.1016/j.clineuro.2021.107014

J Acad Nutr Diet. 2021 Nov 15:S2212-2672(21)01486-6. doi: 10.1016/j.jand.2021.11.009. Online ahead of print.

ABSTRACT

BACKGROUND: The health benefits of diets rich in fruits and vegetables (FV) are well established. Recent observational and intervention research suggests that FV consumption may also exert a positive effect on psychological well-being.

OBJECTIVE: This study aimed to assess changes in mean Subjective Happiness Scale (SHS) scores in response to consuming DGA recommended types and amounts of vegetables. It was hypothesized that increased vegetable consumption would increase mean SHS scores.

DESIGN: This study investigated a secondary outcome of a randomized, parallel, non-blinded controlled trial with a 1:1 allocation ratio to a provided vegetable intervention or attention control group.

PARTICIPANTS/SETTING: Men and women (n=75) aged 18-65 years, body mass index ≥25 kg/m², with low habitual vegetable consumption were recruited from Grand Forks, ND, December 2016 to January 2018, for this community-based study.

INTERVENTION: The vegetable intervention consisted of an 8-week feeding phase during which participants were provided with vegetables in DGA recommended types and amounts. The attention control group was not provided vegetables but completed the same testing schedule as the vegetable intervention group.

MAIN OUTCOME MEASURE: Mean SHS scores were assessed before and after the intervention.

STATISTICAL ANALYSES: Mean SHS scores were analyzed using a 2-way factorial mixed linear model analysis of variance.

RESULTS: A significant interaction between treatment and visit (P=0.015) revealed greater mean SHS scores at week 8 than at baseline in the vegetable intervention group (+0.23 ± 0.11 (mean difference ± standard error of the difference) but no change in the attention control group (-0.15 ± 0.11).

CONCLUSIONS: Greater mean SHS scores were observed after increasing vegetable consumption to meet DGA recommendations, suggesting that adhering to DGA vegetable guidance may help promote psychological well-being.

PMID:34793989 | DOI:10.1016/j.jand.2021.11.009

Ecotoxicol Environ Saf. 2021 Nov 15;228:112986. doi: 10.1016/j.ecoenv.2021.112986. Online ahead of print.

ABSTRACT

OBJECTIVE: This study aimed to examine the relationships among N, N-dimethylformamide (DMF) exposure, cytochrome P4502E1 (CYP2E1) single nucleotide polymorphisms (SNPs) (rs2031920, rs3813867, rs6413432), transmembrane 6 superfamily member 2 (TM6SF2) SNP rs58542926 and non-alcoholic fatty liver disease (NAFLD).

METHODS: Baseline data were collected from participants who were then followed for 5 years in a prospective cohort study. The cohort initially consisted of 802 workers and ultimately included 660 people, all of whom underwent annual occupational health examinations from 2010 to 2015.

RESULTS: The above-threshold group (≥7.3 mg/m³ adjusted relative risk (RR)= 3.620, 95%CI 2.072-6.325) was significantly more likely to develop NAFLD than the below-threshold group (<7.3 mg/m³). The TM6SF2 SNP rs58542926 CT (adjusted RR=3.921, 95% CI 2.329-6.600, P = 0.000) and CT+TT (adjusted RR=4.385, 95% CI 2.639-7.287, P = 0.000) genotypes were risk factors for NAFLD, as compared with the TM6SF2 rs58542926 CC genotype. Each dose group (below-threshold group and above-threshold group) interacting with the genotype of TM6SF2 SNP rs58542926 had an adjusted RR from 7.764 (95% CI 3.272-18.420, P = 0.000) to 24.022 (95% CI 8.971-64.328, P = 0.000). The T allele of rs58542926 in the TM6SF2 gene may be a risk factor for susceptibility to DMF-induced NAFLD.

CONCLUSION: Polymorphisms of TM6SF2 SNP rs58542926 may play an important role in susceptibility to NAFLD after exposure to DMF.

PMID:34794021 | DOI:10.1016/j.ecoenv.2021.112986

Contemp Clin Trials. 2021 Nov 15:106625. doi: 10.1016/j.cct.2021.106625. Online ahead of print.

ABSTRACT

MOTIVATION: Platform designs – master protocols that allow for new treatment arms to be added over time – have gained considerable attention in recent years. Between 2001 and 2019, 16 platform trials were initiated globally. The COVID-19 pandemic seems to have provided a new motivation for these designs. We conducted a rapid review to quantify and describe platform trials used in COVID-19.

METHODS: We cross-referenced PubMed, ClinicalTrials.gov, and the Cytel COVID-19 Clinical Trials Tracker to identify platform trials, defined by their stated ability to add future arms.

RESULTS: We identified 58 COVID-19 platform trials globally registered between January 2020 and May 2021. According to trial registries, 16 trials have added new therapies (median 3, IQR 4) and 11 have dropped arms (median 3, IQR 2.5). About 50% of trials publicly share their protocol, and 31 trials (53%) intend to share trial data. Forty-nine trials (84%) explicitly report adaptive features, and 21 trials (36%) state Bayesian methods.

CONCLUSIONS: During the pandemic, there has been a surge in the number of platform trials compared to historical use. While transparency in statistical methods and clarity of data sharing policies needs improvement, platform trials appear particularly well-suited for rapid evidence generation. Trials secured funding quickly and many succeeded in adding new therapies in a short time period, thus demonstrating the potential for these trial designs to be implemented beyond the pandemic. The evidence gathered here may provide ample insight to further inform operational, statistical, and regulatory aspects of future platform trial conduct.

PMID:34793985 | DOI:10.1016/j.cct.2021.106625

J Pain Symptom Manage. 2021 Nov 15:S0885-3924(21)00610-2. doi: 10.1016/j.jpainsymman.2021.11.003. Online ahead of print.

ABSTRACT

CONTEXT: Episodic breathlessness is characterized by increased breathlessness intensity, and it is burdensome for patients. A vicious cycle of breathlessness-anxiety/panic-breathlessness leads to emergencies that can rarely be alleviated by drugs. Non-pharmacological interventions seem to be beneficial: Can a brief cognitive and behavioral intervention help patients to better manage episodic breathlessness?

OBJECTIVES: To evaluate the feasibility, safety, acceptability, and potential effects of a brief cognitive and behavioral intervention for the management of episodic breathlessness.

METHODS: Between February 2019 and February 2020, 49 patients with life-limiting diseases suffering from episodic breathlessness were enrolled in the single-arm phase II study. The baseline assessment was followed by the 1- to 2-hour intervention. In weeks two, four, and six after the intervention, the outcomes (main outcome of potential effects: mastery of breathlessness) were assessed, and in week six, a qualitative interview, and the final assessment took place. A mixed-methods approach was used to evaluate mainly the feasibility, including interviewing informal carers.

RESULTS: 46/49 patients (24 female; 36 with COPD; mean age: 66.0 years) participated in the baseline assessment, 38 attended the intervention, 32 completed the final assessment, and 22 were interviewed. Study procedures and the intervention were feasible and mainly well accepted and patients did not experience burdens caused by it (28/32). In the interviews, patients described a positive change in their competencies in managing episodic breathlessness and feelings of anxiety during the episode. Mastery of breathlessness improved after the intervention.

CONCLUSION: The brief cognitive and behavioral intervention and the study procedures are feasible, safe, and well accepted. We can describe a change for better management of episodic breathlessness in patients after the intervention, still, this needs to be evaluated in a Phase III trial for inclusion in the management of episodic breathlessness.

KEY MESSAGE: The brief cognitive and behavioral intervention shows a positive change in the management of episodic breathlessness in patients with life-limiting diseases by reducing panic and anxiety in breathlessness episodes and promoting a feeling of competence in managing the episodes. It is safe, feasible, and acceptable.

PMID:34793948 | DOI:10.1016/j.jpainsymman.2021.11.003

Biochim Biophys Acta Mol Cell Biol Lipids. 2021 Nov 15:159082. doi: 10.1016/j.bbalip.2021.159082. Online ahead of print.

ABSTRACT

Lung cancer represents one of the leading worldwide causes of cancer death, but the pathobiochemistry of this disease is still not fully understood. Here we characterize the lipidomic and metabolomic profiles of the tumor and surrounding normal tissues for 23 patients with non-small cell lung cancer. In total, 500 molecular species were identified and quantified by a combination of the lipidomic shotgun tandem mass spectrometry (MS/MS) analysis and the targeted metabolomic approach using liquid chromatography (LC) – MS/MS. The statistical evaluation includes multivariate and univariate methods with the emphasis on paired statistical approaches. Our research revealed significant changes in several biochemical pathways related to the central carbon metabolism, acylcarnitines, dipeptides as well as the disruption in the lipid metabolism observed mainly for glycerophospholipids, sphingolipids, and cholesteryl esters.

PMID:34793969 | DOI:10.1016/j.bbalip.2021.159082

P R Health Sci J. 2021 Sep;40(3):115-119.

ABSTRACT

OBJECTIVE: To estimate the prevalence of short root anomaly (SRA) in a group of Puerto Ricans at the Advanced Education Program in Orthodontics of the University of Puerto Rico.

METHODS: A cross-sectional study was conducted with digital panoramic x-rays of 203 patients (112 females and 91 males; mean age: 17 years) in Puerto Rico. Utilizing the modified Lind’s method, 406 maxillary right and left central incisors (1) were measured and evaluated for SRA. Root and crown length and R/C ratio were compared by sex and side. Linear regression was used to evaluate the associations between the R/C ratio and age, sex, and side (right/left). All the statistical analyses were evaluated using significance level of .05 (2).

RESULTS: The prevalence of SRA was 0.49%. The average root and crown lengths for the maxillary right and left central incisors were 19.47 and 10.28 mm, respectively. Sex was associated with root and crown length, not with the R/C ratio. No differences were observed in the R/C ratio by the side. There were no significant associations between age, sex, and side and R/C ratio in the multivariate analysis.

CONCLUSION: The prevalence of SRA in our population is lower than any reported in the literature. The R/C ratio in our Hispanic population was the highest compared with those of other ethnicities. Neither the sex nor the side of the incisor was associated with the R/C ratio. These findings are contrary to those of prior reports stating that males have higher R/C ratios than females.

PMID:34792924