Tag: statistics

Clin Res Hepatol Gastroenterol. 2022 Apr 4:101921. doi: 10.1016/j.clinre.2022.101921. Online ahead of print.

ABSTRACT

BACKGROUND: Little is known about small bowel capsule endoscopy (SBCE) outcomes in patients with surgically altered anatomy.

AIMS: To assess the feasibility and diagnostic yield of orally ingested SBCE to investigate obscure gastrointestinal bleeding (OGIB) in patients with surgically altered gastric anatomy, compared to native gastric anatomy.

METHODS: 207 patients with OGIB were selected from an open, multicenter, retrospective cohort (SAGA study) and match-paired according to age, gender and bleeding type (overt/occult) to 207 control patients from a randomized controlled trial (PREPINTEST). Primary outcomes were the diagnostic yield (P1 or P2 findings), completion rate (CR), adverse events rate AER, and small bowel transit time (SBTT).

RESULTS: The diagnostic yield was not statistically different between groups (44.9% in SAGA vs 42.5% in control patients). Inflammatory/ulcerated lesions were significantly more frequent in patients with SAGA (43.0% vs 29.3%). The median SBTT was significantly longer in the SAGA group than in control patients (283 vs 206 minutes), with a significantly lower CR (82.6% vs 89.9%); Adverse events were scarce (0.5% vs 0.0%).

CONCLUSION: Patients with surgically altered gastric anatomy should benefit from SBCE investigation for OGIB as much as non-operated patients.

PMID:35390539 | DOI:10.1016/j.clinre.2022.101921

J Acad Nutr Diet. 2022 Apr 4:S2212-2672(22)00175-7. doi: 10.1016/j.jand.2022.03.018. Online ahead of print.

ABSTRACT

BACKGROUND: Accurately estimating portion sizes remains a challenge in dietary assessment. Digital images used in online 24-hour dietary recalls may be conducive to accuracy.

OBJECTIVE: The current analyses were conducted to examine the accuracy of portion size estimation by women with low incomes who completed 24-hour dietary recalls using the online Automated Self-Administered 24-hour Dietary Assessment Tool (ASA24) in the Food and Eating Assessment STudy (FEAST) II.

DESIGN: True dietary intake was observed for three meals on one day through a controlled feeding study conducted from May through July, 2016. The following day, participants completed an unannounced 24-hour dietary recall using ASA24, independently or with assistance in a small group setting.

PARTICIPANTS/SETTING: Participants included 302 women aged 18 to 82 years living in the Washington, DC area who met the income thresholds for the Supplemental Nutrition Assistance Program.

MAIN OUTCOME MEASURES: The accuracy of portion size estimation was assessed by comparing the weight truly consumed (observed) and the weight reported for pre-determined categories of foods and beverages.

STATISTICAL ANALYSES PERFORMED: The differences between observed and reported portions were examined and linear regression tested differences by recall condition. Analyses were conducted by condition and repeated with stratification by racial/ethnic identity, education, and body mass index.

RESULTS: On average across foods and beverages, reported portion sizes were 7.4 grams (95% CI, 4.3-10.5) and 6.4 grams (95% CI, 2.8-10.0) higher than observed portion sizes in the independent and assisted conditions, respectively. Portion sizes were overestimated for small pieces and shaped foods in both conditions, as well as for amorphous/soft foods in the assisted condition and underestimated for single unit foods in both conditions. Misestimation was fairly consistent by participants’ race/ethnicity, education, and body mass index, to varying magnitudes.

CONCLUSIONS: Women with low incomes overestimated the amounts of foods and beverages consumed across several categories using online 24-hour dietary recalls with digital images to support portion size estimation. Assistance with ASA24 had little impact on accuracy.

PMID:35390532 | DOI:10.1016/j.jand.2022.03.018

Photodiagnosis Photodyn Ther. 2022 Apr 4:102854. doi: 10.1016/j.pdpdt.2022.102854. Online ahead of print.

ABSTRACT

PURPOSE: To determine the acute and cumulative effect of hyperbaric oxygen therapy (HBOT) on retina and choroid tissue in healthy eyes.

MATERIAL AND METHODS: Thirty-five subjects who were planned to undergo HBOT for non-ophthalmologic indications comprised the population of this prospective study. Central macular thickness (CMT), retinal nerve fiber layer (RNFL), and choroidal thickness (CT) (3 points: subfoveal area, 500 µm nasal and fovea temporal) were measured using spectral-domain optical coherence tomography (SD-OCT) before HBOT and half an hour after the 1st and 20th sessions of HBOT. The subfoveal choroidal area was segmented using ImageJ software with the binarization technique on enhanced depth imaging (EDI) OCT images. Choroidal area (CA), luminal area (LA), and stromal area (SA) were calculated. Choroidal vascularity index (CVI) was determined as the ratio between LA and CA.

RESULTS: The right eyes of 35 patients aged between 22 and 59 years were enrolled in the study. The mean CMT values of the patients were 259.36 ± 22.31 µm, 256.94 ± 22.72 µm, and 254.58 ± 23.02 µm before HBOT, after the 1st session, and after the 20th session, respectively. The change in CMT values before and after HBOT was statistically significant (p=0.001). When the patients’ RNFL, CT, CA, SA, LA, and CVI changes before and after the HBOT were examined, no statistically significant difference was found (p>0.05).

CONCLUSIONS: Our study is the first to jointly evaluate the effect of HBOT on the vascular and stromal components of the choroid and macula in healthy eyes. Due to its thinning effect on the macula, it can be preferred as an adjunctive and facilitating treatment option in addition to current treatments in patients with macular edema due to retinal vascular disorders.

PMID:35390520 | DOI:10.1016/j.pdpdt.2022.102854

J Mol Diagn. 2022 Apr 4:S1525-1578(22)00075-7. doi: 10.1016/j.jmoldx.2022.03.004. Online ahead of print.

ABSTRACT

In minimal residual disease (MRD), where there are exceedingly low target copy numbers, droplet digital PCR (ddPCR) can improve the quantitation. However, we currently lack the standards for ddPCR data analysis and results for MRD interpretation in acute lymphoblastic leukemia (ALL). Here, for Ig/TCR-based MRD quantitation, we propose an objective, statistics-based analytic algorithm. In 161 post-induction samples from 79 children with ALL, we performed MRD quantitation by ddPCR and qPCR using the same markers and primer-probe sets. The ddPCR raw data were analysed using an automated algorithm. For assigning MRD positive/negative status, ddPCR and qPCR results were highly concordant (P<0.0001): 98% (50/51) of qPCR positive were positive by ddPCR, while 95% (61/64) of qPCR negative were also negative by ddPCR. For MRD quantitation, both qPCR and ddPCR were tightly correlated (R²=0.94). Using more DNA (1 μg ×7 vs 630 ng ×3), ddPCR improved the sensitivity of MRD quantitation by one-log₁₀ (median MRD positive cut-off 1.6×10^-5). With the improved sensitivity by ddPCR, 83% (29/35) of positive-not-quantifiable results by qPCR could be assigned with positive/negative MRD status. We also determined that 7 replicates of tested samples and negative controls were optimal for the assay. Compared to qPCR, for Ig/TCR-based MRD quantitation, ddPCR could improve MRD sensitivity by one log₁₀. We proposed an automatable, statistics-based algorithm that minimized inter-operator variance for ddPCR MRD.

PMID:35390515 | DOI:10.1016/j.jmoldx.2022.03.004

Infect Genet Evol. 2022 Apr 4:105279. doi: 10.1016/j.meegid.2022.105279. Online ahead of print.

ABSTRACT

As surges of the COVID-19 pandemic continue globally, including in Palestine, several new SARS-CoV-2 variants have been introduced. This expansion has impacted transmission, disease severity, virulence, diagnosis, therapy, and natural and vaccine-induced immunity. Here, 183 whole genome sequences (WGS) were analyzed, of which 129 were from Palestinian cases, 62 of which were collected in 11 Palestinian districts between October 2020 and April 2021and sequenced completely . A dramatic shift from the wild type to the Alpha variant (B 1.1.7) was observed within a short period of time. Cluster mapping revealed statistically significant clades in two main Palestinian cities, Al-Khalil (Monte Carlo hypothesis test-Poisson model, P = 0.00000000012) and Nablus (Monte Carlo hypothesis test-Poisson model, P = 0.014 and 0.015). The phylogenetic tree showed three main clusters of SARS-CoV-2 with high bootstrap values (>90). However, population genetics analysis showed a genetically homogenous population supported by low Wright’s F-statistic values (Fst <0.25), high gene flow (Nm > 3), and statistically insignificant Tajima’s D values (Tajima’s test, neutrality model prediction, P = 0.02). The Alpha variant, rapidly replaced the wild type, causing a major surge that peaked in April 2021, with an increased COVID-19 mortality rate, especially, in the Al-Khalil and Nablus districts. The source of introduction remains uncertain, despite the minimal genetic variation. The study substantiates the use of WGS for SARS-CoV-2 surveillance as an early warning system to track down new variants requiring effective control.

PMID:35390503 | DOI:10.1016/j.meegid.2022.105279

World Neurosurg. 2022 Apr 4:S1878-8750(22)00416-8. doi: 10.1016/j.wneu.2022.03.123. Online ahead of print.

ABSTRACT

PURPOSE: Immunotherapy has revolutionized cancer treatment in the past decade, but significant hurdles remain. Human studies with immune checkpoint inhibitors (ICIs) targeting programmed cell death protein have demonstrated suboptimal efficacy in the setting of low-grade gliomas (LGG). Identification of mechanisms leading to inadequate anti-tumor immunity is paramount. The current study evaluates and validates barriers to immunotherapy using a novel machine learning algorithm.

METHODS: We utilized The Cancer Genome Atlas (TCGA) to generate expression levels of 28 immune genes related to known immunotherapeutic targets or lymphocyte cytolytic activity. We created training and testing groups and three machine learning models to determine the genes most highly correlated to cytolytic activity (CYT). The three models were multiple regression by exhaustive selection, LASSO, and random forest. We validated computational results by comparing expression of pertinent genes in patient-derived glioma samples.

RESULTS: Our models demonstrated linearity, a low mean-squared error, and consistent results with respect to the most important variables. Expression of ICOS, IDO1, and CD40 were the most important variables in all models and demonstrated positive correlation with CYT. Other variables included TIGIT and CD137. Genetic analysis from three IDH-mutants (IDHm) and three IDH-wild type (IDHwt) patient-derived glioma samples validated TCGA data and demonstrated lower levels of CYT in IDHm gliomas compared to IDHwt.

CONCLUSION: This novel methodology has elucidated three potential targets for immunotherapy development in LGG. We also demonstrated a novel method of analyzing data using advanced statistical techniques that can be further employed in developing treatments for other diseases as well.

PMID:35390499 | DOI:10.1016/j.wneu.2022.03.123

J Clin Psychiatry. 2022 Apr 4;83(2):22f14455. doi: 10.4088/JCP.22f14455.

ABSTRACT

Selective serotonin reuptake inhibitors (SSRIs) may predispose to postpartum hemorrhage (PPH) by interfering with platelet-mediated hemostasis and serotonin-mediated myometrial contractility. A meta-analysis of 8 observational studies found that, regardless of drug class, gestational exposure to antidepressants was associated with a small (odds ratio, 1.25) but statistically significantly increased risk of PPH; however, this finding was true only when antidepressant exposure was proximal to the date of delivery. A recent, moderately large, nationally representative, Swedish observational study also found that gestational exposure to SSRIs was associated with a significantly increased risk of PPH; the crude number needed to harm was 48. For reasons related to the methodology employed, it is possible that the risk was underestimated in this study. The findings of the meta-analysis and of the observational study are examined with a view to help readers understand how to critically read and interpret the research literature in the field. A reasonable viewpoint is that the increase in risk of PPH associated with gestational exposure to SSRIs is smaller than the increase in risk associated with obstetric risk factors for PPH; nevertheless, following precautionary measures would be wise. Such measures would include the routine administration of a uterotonic agent immediately after delivery to all women who have received serotonin reuptake inhibitor treatment during the month preceding delivery; the choice of uterotonic agent would depend on local hospital protocols. Women at risk should also be closely monitored for continued blood loss during the first 24 hours after delivery.

PMID:35390232 | DOI:10.4088/JCP.22f14455

Dent Traumatol. 2022 Apr 7. doi: 10.1111/edt.12750. Online ahead of print.

ABSTRACT

BACKGROUND/AIMS: Approximately 20% of patients with maxillofacial trauma are women, but few articles have analysed this. The aim of this multicentric, prospective, epidemiological study was to analyse the characteristics of maxillofacial fractures in the female population managed in 14 maxillofacial surgery departments on five continents over a 1-year period.

METHODS: The following data were collected: age (0-18, 19-64, or ≥65 years), cause and mechanism of the maxillofacial fracture, alcohol and/or drug abuse at the time of trauma, fracture site, Facial Injury Severity Scale score, associated injury, day of trauma, timing and type of treatment, and length of hospitalization.

RESULTS: Between 30 September 2019 and 4 October 2020, 562 of 2387 patients hospitalized with maxillofacial trauma were females (24%; M: F ratio, 3.2:1) aged between 1 and 96 years (median age, 37 years). Most fractures occurred in patients aged 20-39 years. The main causes were falls (43% [median age, 60.5 years]), which were more common in Australian, European and American units (p < .001). They were followed by road traffic accidents (35% [median age, 29.5 years]). Assaults (15% [median age, 31.5 years]) were statistically associated with alcohol and/or drug abuse (p < .001). Of all patients, 39% underwent open reduction and internal fixation, 36% did not receive surgical treatment, and 25% underwent closed reduction.

CONCLUSION: Falls were the main cause of maxillofacial injury in the female population in countries with ageing populations, while road traffic accidents were the main cause in African and some Asian centres, especially in patients ≤65 years. Assaults remain a significant cause of trauma, primarily in patients aged 19-64 years, and they are related to alcohol use.

PMID:35390219 | DOI:10.1111/edt.12750

J Cosmet Dermatol. 2022 Apr 7. doi: 10.1111/jocd.14978. Online ahead of print.

ABSTRACT

BACKGROUND: Onychomycosis, the most prevailing affliction of the nail, accounts for approximately 90% of the toenail infection worldwide. Owing to this infection, the affected patients experience reduced quality of their life as its awful appearance undermines their daily activities and social interactions. Onychomycosis is notoriously strenuous to cure. Systemic therapy, though effective, possess severe complication of toxicities, contra-indication, and drug-drug interaction. Albeit topical therapy is favorable to its localized effect, its potency relates to the effective concentration of the antifungal drugs achieved at the infection site. An approach to accomplish this goal would be acquiring benefits from the terpenes as penetration enhancers from natural sources. This investigation aimed to study the effectiveness of six terpenes, namely safranal, lavandulol, rose oxide, 3-methyl-2-butene-1-ol, linalool, and limonene, as potential penetration enhancers for improved nail permeation of fluconazole through the human nail.

METHODS: Ex vivo permeation experiments were carried out by soaking the nail clippings of human volunteers in control and working solutions containing fluconazole (5 mg/ml) per se and fluconazole (5 mg/ml) with 6% of each terpene, including safranal, lavandulol, rose oxide, 3-methyl-2-butene-1-ol, linalool, and limonene, respectively, for 48 hours. The amount of fluconazole in nail clippings was quantified using an HPLC method.

RESULTS: Statistical analysis showed that fluconazole transungual permeation was influenced by the studied terpenes in the following order: safranal > lavandulol acetate > limonene > rose oxide (P-value > 0.05) while the other terpenes showed no significant difference with the control group and safranal represents as the most effective permeation enhancer for the transungual delivery of fluconazole.

CONCLUSION: It is concluded that the safranal can be successfully used as a safe and potential permeation enhancer to enhance the transungual delivery of fluconazole for the treatment of onychomycosis.

PMID:35390220 | DOI:10.1111/jocd.14978