Tag: statistics

Epilepsy Behav. 2021 Feb 12;117:107855. doi: 10.1016/j.yebeh.2021.107855. Online ahead of print.

ABSTRACT

OBJECTIVES: We assessed the impact of COVID-19 on children with epilepsy and their families, focusing on epilepsy management, family routines, learning, and adherence to Centers for Disease Control and Prevention (CDC) pandemic guidelines (e.g., social distancing, mask wearing) within the first six months of the pandemic. Group differences in COVID-19 impact on families were also examined based on race and ethnicity, being medically and/or geographically underserved, and insurance status.

METHODS: Participants (n = 131) included children with epilepsy and their families from two clinical trials. The Impact of COVID-19 on Pediatric Epilepsy Management (ICPEM) measure was developed and administered to caregivers online from April 2020 to September 2020 across four large pediatric hospitals. Administration of the ICPEM occurred both during routine study assessments and an additional acute time point to obtain information early in the pandemic (e.g., April and May 2020). Descriptive statistics and t-tests were used for analyses.

RESULTS: Data indicate minor to moderate impact of COVID-19 on pediatric epilepsy management. Caregivers of children with epilepsy reported the most impact on education and social functioning. Adherence to CDC guidelines was reported to be high. Those having public insurance reported greater difficulties obtaining daily anti-seizure medications compared to those with private insurance.

CONCLUSIONS: This study presents important initial data regarding the impact of COVID-19 epilepsy management and daily functioning in children with epilepsy and their families. While the acute impact of COVID-19 restrictions appear to be mild to moderate, it is unclear what the long-term impact of the pandemic will be on families of children with epilepsy.

PMID:33636530 | DOI:10.1016/j.yebeh.2021.107855

Health Expect. 2021 Feb 26. doi: 10.1111/hex.13214. Online ahead of print.

ABSTRACT

BACKGROUND: Less than 20% of youth who experience mental health difficulties access and receive appropriate treatment. This is exacerbated by barriers such as stigma, confidentiality concerns and lack of mental health literacy. A youth team developed the Wellness Quest: a health literacy tool to enable help-seeking youth to advocate for themselves.

OBJECTIVE: To evaluate the content, presentation and utility of the Wellness Quest tool among youth.

PARTICIPANTS: Participants aged 14 to 26.

METHODS: A youth research team conducted five focus groups and one online survey to evaluate the Wellness Quest tool. Thematic analysis was used to analyse the qualitative data, and descriptive statistics were used to explore the survey results.

MAIN RESULTS: Overall evaluations of the Wellness Quest were positive: participants felt it would be useful during their mental health help-seeking journey. Participants expressed the need for information about services for specific populations, such as Indigenous, immigrants, refugees and 2SLGBTQ + youth. They expressed that the tool should be available in complementary online and print versions.

DISCUSSION: Improving mental health literacy may improve mental health by enabling youth and those who support them to recognize and respond to signs of distress and understanding where and how to get help. The Wellness Quest tool may equip youth with the knowledge to make informed decisions and advocate for their own mental health, thereby facilitating help-seeking among youth.

PATIENT OR PUBLIC CONTRIBUTION: Youth as service users led all stages of the project, from designing and conducting the study and analysing the data to writing the manuscript.

PMID:33636052 | DOI:10.1111/hex.13214

Int J Clin Pract. 2021 Feb 26:e14118. doi: 10.1111/ijcp.14118. Online ahead of print.

ABSTRACT

PURPOSE: To investigate the prediction values of the preoperative NLR, LMR, PLR, MPV, RDW for recurrence and progression of patients with non-muscle invasive bladder cancer (NMIBC).

METHODS: In this prospective study, 94 consecutive patients, newly diagnosed with NMIBC between July 2017 – August 2018 were included. The blood samples were collected from patients before transurethral resection of bladder tumor (TURB) and NLR, LMR, PLR, RDW, MPV values were calculated. The effect of these preoperative inflammatory parameters and other clinicopathological parameters on recurrence and progression rates were evaluated. Kaplan-Meier and multivariate Cox regression analyses were performed to identify significant prognostic variables.

RESULTS: The mean follow-up was 11 ± 6.4 months. Recurrence was observed in 35.1% and progression was detected in 7.4% of the patients. Neutrophil-lymphocyte ratio was statistically significantly associated with both recurrence (p = 0.01) and progression (p = 0.035) whereas lymphocyte-monocyte ratio was only associated with recurrence (p = 0.038). In the survival analyses, the relationship between recurrence and LMR was confirmed in both univariate (p = 0.021) and multivariate (p = 0.022) analyses. The relationship between NLR and recurrence was confirmed in univariate analysis (p = 0.019), however in multivariate analysis was found to be statistically insignificant (p = 0.051).

CONCLUSIONS: Lymphocyte-monocyte ratio might be an easy obtainable, non-invasive and cost-effective method for predicting recurrence of disease in patients with non-muscle invasive bladder cancer.

PMID:33636055 | DOI:10.1111/ijcp.14118

Adv Clin Exp Med. 2021 Feb 26. doi: 10.17219/acem/130357. Online ahead of print.

ABSTRACT

BACKGROUND: The laparoscopic totally extraperitoneal inguinal hernia repair (TEP), unlike the Lichtenstein tension-free mesh repair, allows for inspecting the femoral canal area for the presence of an occult femoral hernia.

OBJECTIVES: To determine the incidence of an unsuspected femoral hernia in patients undergoing TEP repair.

MATERIAL AND METHODS: Data was collected prospectively from 180 patients (23 women) who underwent hernia repair, including examination of the femoral canal, between November 2017 and March 2019, and the incidence of a femoral hernia was determined. Correlations between the incidence of a femoral hernia and sex, age and the type of inguinal hernia diagnosed in the patients (indirect, direct, both indirect and direct) were assessed.

RESULTS: Femoral hernias were found in 14 patients (7.77%). None of the hernias had previously been detected clinically. The incidence of a femoral hernia was higher in women (6/23, 26.07%) than in men (8/157, 5.09%). The incidence of a femoral hernia was higher in older patients: the average age of patients with a femoral hernia was 57.86 years (median: 60 years), whereas the average age of patients without a femoral hernia was 49.92 years (median: 49 years). However, the correlation was not statistically significant. No correlation was found between the incidence of a femoral hernia and the type of inguinal hernia diagnosed in the patients (direct, indirect, both indirect and direct).

CONCLUSIONS: The TEP repair allows for detecting and repairing an occult femoral hernia.

PMID:33636062 | DOI:10.17219/acem/130357

Int J Clin Pract. 2021 Feb 26:e14115. doi: 10.1111/ijcp.14115. Online ahead of print.

ABSTRACT

AIMS: To evaluate the effect of pre-RIRS ESWL on the efficiency and safety of RIRS in the treatment of proximal ureter stones.

METHODS: The patients in the study population were divided into 2 groups. Group-1 was composed of patients who had undergone ESWL for proximal ureter stones before RIRS, and Group-2 was composed of patients who directly underwent RIRS without any prior ESWL. The clinical and demographic properties of the patients were analysed in the RIRSearch database. The operative outcomes, peroperative complications, postoperative complications, hospitalization time and the stone-free rates were compared between the groups.

RESULTS: There were 56 patients in Group-1 and 95 patients in Group-2. The demographic and clinical properties were similar between the groups. The stone-free rates, peroperative complications and postoperative complications were also similar between the groups; however, the fluoroscopy time was significantly higher in Group-1 (p=.043). The cut-off duration of 10 weeks between ESWL and RIRS had reasonable/favourable discriminating ability, with a 51% sensitivity and 88% specificity rate for stone-free status.

CONCLUSION: Performing ESWL on the proximal ureter stones before RIRS did not change the efficacy and safety of RIRS. The time between the patient’s last ESWL session and RIRS had a predictive value for stone-free status, but did not have any effect on complications.

PMID:33636023 | DOI:10.1111/ijcp.14115

Prostate. 2021 Feb 26. doi: 10.1002/pros.24110. Online ahead of print.

ABSTRACT

BACKGROUND: AR-V7-positive metastatic prostate cancer is a lethal phenotype with few treatment options and poor survival.

METHODS: The two-cohort nonrandomized Phase 2 study of combined immune checkpoint blockade for AR-V7-expressing metastatic castration-resistant prostate cancer (STARVE-PC) evaluated nivolumab (3 mg/kg) plus ipilimumab (1 mg/kg), without (Cohort 1) or with (Cohort 2) the anti-androgen enzalutamide. Co-primary endpoints were safety and prostate-specific antigen (PSA) response rate. Secondary endpoints included time-to-PSA-progression-free survival (PSA-PFS), time-to-clinical/radiographic-PFS, objective response rate (ORR), PFS lasting greater than 24 weeks, and overall survival (OS).

RESULTS: Thirty patients were treated with ipilimumab plus nivolumab (N = 15, Cohort 1, previously reported), or ipilimumab plus nivolumab and enzalutamide (N = 15, Cohort 2) in patients previously progressing on enzalutamide monotherapy. PSA response rate was 2/15 (13%) in cohort 1 and 0/15 in cohort 2, ORR was 2/8 (25%) in Cohort 1 and 0/9 in Cohort 2 in those with measureable disease, median PSA-PFS was 3.0 (95% confidence interval [CI]: 2.1-NR) in cohort 1 and 2.7 (95% CI: 2.1-5.9) months in cohort 2, and median PFS was 3.7 (95% CI: 2.8-7.5) in cohort 1 and 2.9 (95% CI: 1.3-5.8) months in cohort 2. Three of 15 patients in cohort 1 (20%, 95% CI: 7.1%-45.2%) and 4/15 patients (26.7%, 95% CI: 10.5%-52.4%) in cohort 2 achieved a durable PFS lasting greater than 24 weeks. Median OS was 8.2 (95% CI: 5.5-10.4) in cohort 1 and 14.2 (95% CI: 8.5-NA) months in cohort 2. Efficacy results were not statistically different between cohorts. Grade-3/4 adverse events occurred in 7/15 cohort 1 patients (46%) and 8/15 cohort 2 patients (53%). Combined cohort (N = 30) baseline alkaline phosphatase and cytokine analysis suggested improved OS for patients with lower alkaline phosphatase (hazards ratio [HR], 0.30; 95% CI: 0.11-0.82), lower circulating interleukin-7 (IL-7) (HR, 0.24; 95% Cl: 0.06-0.93) and IL-6 (HR, 0.13; 95% Cl: 0.03-0.52) levels, and higher circulating IL-17 (HR, 4.53; 95% CI: 1.47-13.93) levels. There was a trend towards improved outcomes in men with low sPD-L1 serum levels.

CONCLUSION: Nivolumab plus ipilimumab demonstrated only modest activity in patients with AR-V7-expressing prostate cancer, and was not sufficient to justify further exploration in unselected patients. Stratification by baseline alkaline phosphatase and cytokines (IL-6, -7, and -17) may be prognostic for outcomes to immunotherapy.

PMID:33636027 | DOI:10.1002/pros.24110

J Thromb Haemost. 2021 Feb 26. doi: 10.1111/jth.15277. Online ahead of print.

ABSTRACT

BACKGROUND: Dabigatran etexilate (DE), a direct oral thrombin inhibitor, has been evaluated in children with venous thromboembolism (VTE) using oral solution, pellets, or capsules.

OBJECTIVES: This study evaluated DE pharmacokinetics (PK) in children with VTE and the appropriateness of a DE pediatric age- and weight-based dosing algorithm. Patients/Methods A population PK model was fitted to data from four single-arm and one randomized, comparative pediatric VTE studies (358 children aged birth to <18 years; 2748 PK observations) and one healthy-adult study (32 males aged <40 years; 1523 PK observations) using nonlinear mixed-effects modeling. A stepwise, covariate, model-building procedure evaluated the influence of covariates (e.g., age, body weight, body surface area [BSA]-normalized renal function, and sex). The final model was used to evaluate the pediatric dosing algorithm, with simulations comparing pediatric trough exposure with reference exposure defined for the pediatric studies.

RESULTS: The population PK of dabigatran was adequately described by a two-compartment model with first-order elimination and absorption. Age, weight, BSA-normalized renal function, and sex were statistically significant covariates (all P<0.05). Apparent clearance increased with age (independently of body weight), diminished with decreasing BSA-normalized renal function, and was lower in females than males. All disposition parameters increased with body weight escalation (allometric scaling). Simulations confirmed that for all DE formulations, the final pediatric dosing algorithms achieved reference exposure without dose adjustment.

CONCLUSIONS: Using a population PK model of DE for children with VTE, simulations showed that the final dosing algorithms were appropriate for all DE formulations; no dose titration was needed.

PMID:33636042 | DOI:10.1111/jth.15277

J Wildl Dis. 2021 Jan 6;57(1):60-70. doi: 10.7589/JWD-D-20-00011.

ABSTRACT

The warthog (Phacochoerus africanus) can be used as a model for investigating disease transmission at the human, wildlife, and livestock interface. An omnivore and scavenger, a warthog moves freely between natural ecotypes, farmland, and human communities and is susceptible to diseases of zoonotic, agricultural, and conservation concern. A retrospective study using 100 individual serum samples collected from May 1999 to August 2016 was performed to determine antibody prevalence to seven pathogens in warthogs from five locations in northeastern South Africa. Higher prevalence of antibodies to African swine fever virus and Mycobacterium bovis were detected in warthogs from the Greater Kruger National Park ecosystem in comparison to lower prevalence of antibodies to M. bovis and no antibodies to African swine fever virus in warthogs from uMhkuze Game Reserve. Low prevalence of antibodies to foot-and-mouth disease virus, Rift Valley fever virus, and influenza A virus was detected in all locations, and no antibodies against Brucella and Leptospira spp. were detected. No statistically significant difference in antibody prevalence was found between sexes for any disease. At the univariate analysis, M. bovis seropositivity was significantly different among age categories, with 49% (35/71) of adults found positive versus 29% (4/14) of juveniles and 9% (1/11) of sub-adults (Fisher’s exact test, P=0.020), and between the sampling locations (Fisher’s exact test, P=0.001). The multivariate model results indicated that juvenile warthogs had lower odds of testing positive to M. bovis antibodies than adults (juveniles’ odds ratio [OR]=0.17, 95% confidence interval [CI]: 0.02-1.0), although this result was not statistically significant at the 5% level (P=0.052). For warthogs sampled at Satara Buffalo Camp, the odds (OR=0.22, 95% CI: 0.035-0.96) of being M. bovis antibody positive were significantly lower (P=0.043) than for warthogs sampled at Skukuza. Of particular interest in this study was the detection of warthogs seropositive for influenza A virus.

PMID:33635986 | DOI:10.7589/JWD-D-20-00011

J Wildl Dis. 2021 Jan 6;57(1):242-245. doi: 10.7589/JWD-D-20-00095.

ABSTRACT

We determined venous blood gas, acid-base, and biochemical parameters for thirteen free-ranging Indian flying foxes (Pteropus giganteus) in Myanmar, using a handheld i-STAT analyzer with CG8+ and CHEM8 cartridges. For field-based projects, portable blood analyzers enable identification and management of electrolyte and acid-base imbalances and collection of physiologic data, but present logistical challenges.

PMID:33635999 | DOI:10.7589/JWD-D-20-00095

Stapp Car Crash J. 2020 Nov;64:1-30.

ABSTRACT

The CORA rating metric is frequently used in the field of injury biomechanics to compare the similarity of response time histories. However, subjectivity exists within the CORA metric in the form of user-customizable parameters that give the metric the flexibility to be used for a variety of applications. How these parameters are customized is not always reported in the literature, and it is unknown how these customizations affect the CORA scores. Therefore, the purpose of this study was to evaluate how variations in the CORA parameters affect the resulting similarity scores. A literature review was conducted to determine how the CORA parameters are commonly customized within the literature. Then, CORA scores for two datasets were calculated using the most common parameter customizations and the default parameters. Differences between the CORA scores using customized and default parameters were statistically significant for all customizations. Furthermore, most customizations produced score increases relative to the default settings. The use of standard deviation corridors and exclusion of the corridor component were found to produce the largest score differences. The observed differences demonstrated the need for researchers to exercise transparency when using customized parameters in CORA analyses.

PMID:33636001