Tag: statistics

Hosp Pediatr. 2022 Aug 22:e2022006617. doi: 10.1542/hpeds.2022-006617. Online ahead of print.

ABSTRACT

Although the number of randomized controlled trials (RCTs) published each year involving adult populations is steadily rising, the annual number of RCTs published involving pediatric populations has not changed since 2005. Barriers to the broader utilization of RCTs in pediatrics include a lower prevalence of disease, less available funding, and more complicated regulatory requirements. Although child health researchers have been successful in overcoming these barriers for isolated diseases such as pediatric cancer, common pediatric diseases are underrepresented in RCTs relative to their burden. This article proposes a strategy called High-Efficiency RandOmIzed Controlled (HEROIC) trials to increase RCTs focused on common diseases among hospitalized children. HEROIC trials are multicenter RCTs that pursue the rapid, low-cost accumulation of study participants with minimal burden for individual sites. Five key strategies distinguish HEROIC trials: (1) dispersed low-volume recruitment, in which a large number of sites (50-150 hospitals) enroll a small number of participants per site (2-10 participants per site), (2) incentivizing site leads with authorship, training, education credits, and modest financial support, (3) a focus on pragmatic questions that examine simple, widely used interventions, (4) the use of a single institutional review board, integrated consent, and other efficient solutions to regulatory requirements, and (5) scaling the HEROIC trial strategy to accomplish multiple trials simultaneously. HEROIC trials can boost RCT feasibility and volume to answer fundamental clinical questions and improve care for hospitalized children.

PMID:35989332 | DOI:10.1542/hpeds.2022-006617

BMC Med Educ. 2022 Aug 22;22(1):636. doi: 10.1186/s12909-022-03697-w.

ABSTRACT

BACKGROUND: Various rating tools aim to assess simulation debriefing quality, but their use may be limited by complexity and subjectivity. The Debriefing Assessment in Real Time (DART) tool represents an alternative debriefing aid that uses quantitative measures to estimate quality and requires minimal training to use. The DART is uses a cumulative tally of instructor questions (IQ), instructor statements (IS) and trainee responses (TR). Ratios for IQ:IS and TR:[IQ + IS] may estimate the level of debriefer inclusivity and participant engagement.

METHODS: Experienced faculty from four geographically disparate university-affiliated simulation centers rated video-based debriefings and a transcript using the DART. The primary endpoint was an assessment of the estimated reliability of the tool. The small sample size confined analysis to descriptive statistics and coefficient of variations (CV%) as an estimate of reliability.

RESULTS: Ratings for Video A (n = 7), Video B (n = 6), and Transcript A (n = 6) demonstrated mean CV% for IQ (27.8%), IS (39.5%), TR (34.8%), IQ:IS (40.8%), and TR:[IQ + IS] (28.0%). Higher CV% observed in IS and TR may be attributable to rater characterizations of longer contributions as either lumped or split. Lower variances in IQ and TR:[IQ + IS] suggest overall consistency regardless of scores being lumped or split.

CONCLUSION: The DART tool appears to be reliable for the recording of data which may be useful for informing feedback to debriefers. Future studies should assess reliability in a wider pool of debriefings and examine potential uses in faculty development.

PMID:35989331 | DOI:10.1186/s12909-022-03697-w

BMC Cardiovasc Disord. 2022 Aug 21;22(1):380. doi: 10.1186/s12872-022-02818-z.

ABSTRACT

AIM: To evaluate ventricular synchronization and function in patients with right bundle-branch block after left bundle-branch-area pacing (LBBAP) by echocardiography.

METHODS: Forty patients who successfully received LBBAP were selected and divided into the right bundle-branch block group (RBBB group) and the non-RBBB group by pre-operation ECG. Echocardiography and follow-up were performed 1 month after operation. Interventricular synchronization was evaluated by tissue Doppler (TDI), tissue mitral annular displacement (TMAD), and interventricular mechanical delay. The tricuspid annular plane systolic excursion (TAPSE), right ventricular fractional area change (RVFAC), tricuspid annulus sidewall systolic velocity (TV-s’), left ventricular global ventricular longitudinal strain (GLS), right ventricular free wall longitudinal strain (LS-RV), standard deviation of left ventricular 18 segments peak time difference (SDt-L) and standard deviation of right ventricular free wall 3 segments peak time difference (SDt-R) were applied to evaluate intraventricular synchronization and ventricular function.

RESULTS: The difference of displacement peak time of the tricuspid and mitral valves, namely ΔPT_TV-MV measured by TMAD, the difference of systolic time to peak of the tricuspid and mitral valves, namely ΔTs_TV-MV measured by TDI, were statistically different between the two groups (P < 0.05). Compared with the non-RBBB group, there were no statistically significant differences in the GLS, RVFAC, LS-RV, TAPSE, TV-s’, SDt-L, SDt-R (P > 0.05).

CONCLUSION: Echocardiography technology including two-dimensional speckle tracking imaging (2D-STI), TDI, and TMAD can effectively analyze interventricular synchronization, intraventricular synchronization, and ventricular function. Although the movement of the right ventricular myocardium in the RBBB group was slightly later than that of the left ventricular myocardium after LBBAP, LBBAP could still be applied in RBBB patients with pacing indication.

PMID:35989329 | DOI:10.1186/s12872-022-02818-z

Genome Med. 2022 Aug 22;14(1):95. doi: 10.1186/s13073-022-01076-0.

ABSTRACT

BACKGROUND: Multidrug-resistant (MDR) Mycobacterium tuberculosis complex (MTBC) strains are a serious health problem in India, also contributing to one-fourth of the global MDR tuberculosis (TB) burden. About 36% of the MDR MTBC strains are reported fluoroquinolone (FQ) resistant leading to high pre-extensively drug-resistant (pre-XDR) and XDR-TB (further resistance against bedaquiline and/or linezolid) rates. Still, factors driving the MDR/pre-XDR epidemic in India are not well defined.

METHODS: In a retrospective study, we analyzed 1852 consecutive MTBC strains obtained from patients from a tertiary care hospital laboratory in Mumbai by whole genome sequencing (WGS). Univariate and multivariate statistics was used to investigate factors associated with pre-XDR. Core genome multi locus sequence typing, time scaled haplotypic density (THD) method and homoplasy analysis were used to analyze epidemiological success, and positive selection in different strain groups, respectively.

RESULTS: In total, 1016 MTBC strains were MDR, out of which 703 (69.2%) were pre-XDR and 45 (4.4%) were XDR. Cluster rates were high among MDR (57.8%) and pre-XDR/XDR (79%) strains with three dominant L2 (Beijing) strain clusters (Cl 1-3) representing half of the pre-XDR and 40% of the XDR-TB cases. L2 strains were associated with pre-XDR/XDR-TB (P < 0.001) and, particularly Cl 1-3 strains, had high first-line and FQ resistance rates (81.6-90.6%). Epidemic success analysis using THD showed that L2 strains outperformed L1, L3, and L4 strains in short- and long-term time scales. More importantly, L2 MDR and MDR + strains had higher THD success indices than their not-MDR counterparts. Overall, compensatory mutation rates were highest in L2 strains and positive selection was detected in genes of L2 strains associated with drug tolerance (prpB and ppsA) and virulence (Rv2828c). Compensatory mutations in L2 strains were associated with a threefold increase of THD indices, suggesting improved transmissibility.

CONCLUSIONS: Our data indicate a drastic increase of FQ resistance, as well as emerging bedaquiline resistance which endangers the success of newly endorsed MDR-TB treatment regimens. Rapid changes in treatment and control strategies are required to contain transmission of highly successful pre-XDR L2 strains in the Mumbai Metropolitan region but presumably also India-wide.

PMID:35989319 | DOI:10.1186/s13073-022-01076-0

Nutr Clin Pract. 2022 Aug 21. doi: 10.1002/ncp.10903. Online ahead of print.

ABSTRACT

BACKGROUND: Peripheral parenteral nutrition (PPN) represents an alternative option to central parenteral nutrition (CPN) for patients requiring short-term parenteral nutrition (PN). We hypothesized that the use of PPN could be increased in certain patient cohorts referred for PN in our facility.

METHODS: A retrospective observational study investigating the clinical characteristics of patients receiving PN under the nutrition support team over a 5-year period was undertaken. Patients who received PPN were reviewed descriptively. Of the patients who received CPN, representative samples were grouped into those who received PN for ≤7 or >7-28 days (n = 100 each, randomly assigned). Clinical characteristics considered included indication, duration and referring team for PN, and nutrition status. Descriptive statistics and binary logistic regression model for predictors of PN duration of ≤7 or >7-28 days were derived.

RESULTS: Only four patients received PPN for a median of 4 days, most of whom required this route because of loss of central venous access for CPN. A high proportion of patients with no enteral access received CPN for ≤7 days, whereas the majority of patients with malabsorption required >7-28 days of CPN. Being referred for PN following upper gastrointestinal surgery increased the likelihood of CPN use for >7 days (relative risk, 5.7; 95% CI, 1.7-18.9; P = 0.004).

CONCLUSION: Within our service, PN referrals for no enteral access may represent a group in whom PPN could be used in the first instance; those referred with an indication of malabsorption or following upper gastrointestinal surgery may benefit from early commencement of CPN.

PMID:35989305 | DOI:10.1002/ncp.10903

J Oral Sci. 2022 Aug 19. doi: 10.2334/josnusd.22-0147. Online ahead of print.

ABSTRACT

PURPOSE: To evaluate the effect of different surface treatments, ferrule heights, and luting agents on the pull-out bond strength (PBS) of computer-aided design/computer-aided manufacturing (CAD-CAM) monolithic endocrowns.

METHODS: After endodontic treatment and preparation for two endocrown designs (ferrule height 0 mm or 2 mm), CAD-CAM monolithic zirconia endocrowns were fabricated for 80 mandibular molars. Each endocrown design group was then divided on the basis of surface treatment into two groups: half were air-abraded and half were air-abraded/laser-irradiated. Then, all treated groups were further divided into two subgroups (n = 10) and cemented to teeth with either a 10-methacryloyloxydecyl dihydrogen phosphate (MDP)-containing resin luting agent (Panavia SA) or a combination of MDP-containing primer and MDP-free resin luting agent (Monobond Plus/Multilink Automix). PBS was measured with a universal test machine after simulated chewing and thermocycling. Three-way ANOVA and the post-hoc Bonferroni test were used for statistical analysis.

RESULTS: PBS was significantly associated with type of surface treatment, type of luting agent, and ferrule height. Air-abraded/laser-irradiated endocrowns with a 2-mm ferrule that were cemented with Monobond Plus/Multilink Automix had the highest PBS (P < 0.05).

CONCLUSION: Surface treatment with air abrasion/laser irradiation, presence of a ferrule, and priming with an MDP-containing primer increased the PBS of monolithic zirconia endocrowns.

PMID:35989297 | DOI:10.2334/josnusd.22-0147

Drug Discov Ther. 2022 Aug 21. doi: 10.5582/ddt.2022.01046. Online ahead of print.

ABSTRACT

This study aims to clarify the clinical significance of dupilumab-induced elevation of blood eosinophil in Japanese patients with atopic dermatitis (AD). Eosinophil elevation was defined as ≥ 5% increase of eosinophil percentage within one year after dupilumab initiation. Seven patients (15.7%) were shown to have eosinophil elevation, six of whom developed dupilumab-associated conjunctivitis (DAC) and were accompanied with DAC more frequently than those without eosinophil elevation, with statistically significant difference. Eosinophil percentage resolved spontaneously in all seven patients, including the one without DAC, despite the continuation of dupilumab treatment. None of the patients with eosinophil elevation had cardiac or pulmonary complications attributable to the hypereosinophilia. The patients with eosinophil elevation were all male. Furthermore, none of four patients in whom efficacy of dupilumab was < 25% showed eosinophil elevation. Childhood onset tended to be more common in patients with the elevation of eosinophil. This study suggests that most eosinophil elevation is associated with DAC, and that the eosinophil ratio is a biomarker for DAC.

PMID:35989284 | DOI:10.5582/ddt.2022.01046

Clin Breast Cancer. 2022 Aug 3:S1526-8209(22)00171-9. doi: 10.1016/j.clbc.2022.07.009. Online ahead of print.

ABSTRACT

PURPOSE: This research aimed to study the effects of motor exercises on improving shoulder functioning, functional ability, quality of life, depression, and anxiety in patients.

PATIENTS AND METHODS: A randomized clinical trial in which 70 eligible patients referred to the oncology ward participated in two intervention and control groups. The intervention group (N=35) had been doing motor exercises for five weeks. Before the surgery, two days, and five weeks after surgery, shoulder Range Of Motion (ROM) was measured with a goniometer, and the functional capacity level was measured by the 6-Minute-Walk-Test. Quality of life, depression, and anxiety were measured using the EORTC QLQ-C30 and QLQ-BR23; and HADS questionnaires, respectively, at baseline and five weeks after surgery. Descriptive statistics, the T-test, and the Chi-Square t-hotelling model were used to analyze the data.

RESULTS: The results showed that motor exercises had a significant statistical increase in the distance of 6MWT (P<.001) and ROM (P≤.001) compared to the control group. Moreover, there were significant differences in dimensions of patients’ quality of life, depression, and anxiety in the intervention group, compared to the control group (P<.05).

CONCLUSION: Motor exercises had positive effects on improving physical functioning, shoulder ROM, and decreasing patients’ anxiety and depression symptoms, consequently enhancing the quality of life.

PMID:35989239 | DOI:10.1016/j.clbc.2022.07.009

Am J Reprod Immunol. 2022 Aug 21. doi: 10.1111/aji.13606. Online ahead of print.

ABSTRACT

PROBLEM: Pregnancy represents a state of systemic immune activation that is primarily driven by alterations in circulating innate immune cells. Recent studies have suggested that cellular adaptive immune components, T cells and B cells, also undergo changes throughout gestation. However, the phenotypes and functions of such adaptive immune cells are poorly understood. Herein, we utilized high-dimensional flow cytometry and functional assays to characterize T-cell and B-cell responses in pregnant and non-pregnant women.

METHODS: PBMCs from pregnant (n = 20) and non-pregnant (n = 25) women were used for phenotyping of T-cell and B-cell subsets. T-cell proliferation and B-cell activation were assessed by flow cytometry after stimulation, and lymphocyte cytotoxicity was evaluated using a cell-based assay. Statistical comparisons were performed using linear mixed effects models.

RESULTS: Pregnancy was associated with modestly enhanced basal activation of peripheral CD4⁺ T cells. Both CD4⁺ and CD8⁺ T cells from pregnant women showed increased activation-induced proliferation; yet, a reduced proportion of these cells expressed activation markers compared to non-pregnant women. There were no differences in peripheral lymphocyte cytotoxicity between study groups. A greater proportion of B cells from pregnant women displayed memory-like and activated phenotypes, and such cells exhibited higher activation following stimulation.

CONCLUSIONS: Maternal circulating T cells and B cells display distinct responses during pregnancy. The former may reflect the unique capacity of T cells to respond to potential threats without undergoing aberrant activation, thereby preventing systemic inflammatory responses that can lead to adverse perinatal consequences. This article is protected by copyright. All rights reserved.

PMID:35989229 | DOI:10.1111/aji.13606

Endocrinol Diabetes Nutr (Engl Ed). 2022 Aug 18:S2530-0180(22)00130-5. doi: 10.1016/j.endien.2022.07.007. Online ahead of print.

ABSTRACT

INTRODUCTION: Patients with gastroenteropancreatic neuroendocrine tumors (GEPNET) can suffer from malnutrition. This is the first descriptive study of morfo-functional evaluation in GEPNET.

OBJETIVES: To describe a morfo-functional evaluation, and to compare with reference population available, and to correlate different nutritional parameters. Moreover, to compare nutritional evaluation in our study with another same location non-neuroendocrine tumors.

MATERIALS AND METHODS: A retrospective observational study, 50 patients with GEPNET, medium age 61 years. It was collected clinico-pathological characteristics and nutritional status was assessed by anthropometric, laboratory test, bioelectrical impedance analysis, phase angle, hand grip strength, and rectus femoris ultrasound for the assessment of muscle mass. We used SPSS statistics to describe and to analyze correlations of different variables.

RESULTS: Most frequent location of tumor was pancreas and small bowel, tumor grade 1 and advance stage. In morfo-functional evaluation highlighted: a low fat mass percentage (23,5 vs 34,4%), low muscle mass percentage (36,5 vs 41,2%) and low body mass cell percentage (40,4 vs 48,8%) compared with reference population available by sex and age. Standarized phase angle by sex and age result as positive (+0,851). There was no difference in hand grip strength compared with reference population. After a review of differents studies available, phase angle and hand grip strength of non neuroendocrine tumors in same location, could suggest a minor affection of nutritional state in our GEPNET sample. A positive correlation was observed between non classic methods of nutritional evaluation such as bioelectrical impedance analysis, hand grip strength and rectus femoris ultrasound.

CONCLUSION: Patients with gastroenteropancreatic neuroendocrine tumors (GEPNET) show a moderate affection of nutritional status in comparison to general population. Morphofunctional assessment provide us a precise knowledge about nutritional status.

PMID:35989228 | DOI:10.1016/j.endien.2022.07.007