Tag: nevin manimala

Pharm Stat. 2022 Feb 6. doi: 10.1002/pst.2195. Online ahead of print.

ABSTRACT

Several dynamic borrowing methods, such as the modified power prior (MPP), the commensurate prior, have been proposed to increase statistical power and reduce the required sample size in clinical trials where comparable historical controls are available. Most methods have focused on cross-sectional endpoints, and appropriate methodology for longitudinal outcomes is lacking. In this study, we extend the MPP to the linear mixed model (LMM). An important question is whether the MPP should use the conditional version of the LMM (given the random effects) or the marginal version (averaged over the distribution of the random effects), which we refer to as the conditional MPP and the marginal MPP, respectively. We evaluated the MPP for one historical control arm via a simulation study and an analysis of the data of Alzheimer’s Disease Cooperative Study (ADCS) with the commensurate prior as the comparator. The conditional MPP led to inflated type I error rate when there existed moderate or high between-study heterogeneity. The marginal MPP and the commensurate prior yielded a power gain (3.6%-10.4% vs. 0.6%-4.6%) with the type I error rates close to 5% (5.2%-6.2% vs. 3.8%-6.2%) when the between-study heterogeneity is not excessively high. For the ADCS data, all the borrowing methods improved the precision of estimates and provided the same clinical conclusions. The marginal MPP and the commensurate prior are useful for borrowing historical controls in longitudinal data analysis, while the conditional MPP is not recommended due to inflated type I error rates.

PMID:35128780 | DOI:10.1002/pst.2195

J Appl Clin Med Phys. 2022 Feb 7:e13555. doi: 10.1002/acm2.13555. Online ahead of print.

ABSTRACT

PURPOSE: To demonstrate the plan quality and delivery efficiency of volumetric-modulated arc therapy (VMAT) with the Halcyon Linac ring delivery system (RDS) in the treatment of single-isocenter/two-lesion lung stereotactic body radiation therapy (SBRT).

MATERIALS/METHODS: Sixteen previously treated non-coplanar VMAT single-isocenter/two-lesion lung SBRT plans delivered with SBRT-dedicated C-arm TrueBeam Linac were selected. Prescribed dose was 50 Gy to each lesion over five fractions with treatment delivery every other day and AcurosXB algorithm as the final dose calculation algorithm. TrueBeam single-isocenter plans were reoptimized for Halcyon Linac with coplanar geometry. Both TrueBeam and Halcyon plans were normalized for identical combined target coverage and evaluated. Conformity indices (CIs), heterogeneity index (HI), gradient index (GI), gradient distance (GD), and D_2cm were compared. The normal lung V5Gy, V10Gy, V20Gy, mean lung dose (MLD), and dose to organs at risk (OAR) were evaluated. Treatment delivery parameters, including beam-on time, were recorded.

RESULTS: Halcyon plans were statistically similar to clinically delivered TrueBeam plans. No statistical differences in target conformity, dose heterogeneity, or intermediate-dose spillage were observed (all, p > 0.05). Halcyon plans, on average, demonstrated statistically insignificant reduced maximum dose to most adjacent OAR and normal lung. However, Halcyon yielded statistically significant lower maximal dose to the ribs (p = 0.041) and heart (p = 0.026), dose to 1 cc of ribs (p = 0.035) and dose to 5 cc of esophagus (p = 0.043). Plan complexity slightly increased as seen in the average increase of total monitor units, modulation factor, and beam-on time by 480, 0.48, and 2.78 min, respectively. However, the estimated overall treatment time was reduced by 2.22 min, on average. Mean dose delivery accuracy of clinical TrueBeam plans and the corresponding Halcyon plans was 98.9 ± 0.85% (range: 98.1%-100%) and 98.45 ± 0.99% (range: 97.9%-100%), respectively, demonstrating similar treatment delivery accuracy.

CONCLUSION: SBRT treatment of synchronous lung lesions via single-isocenter VMAT on Halcyon RDS is feasible and dosimetrically equivalent to clinically delivered TrueBeam plans. Halcyon provides excellent plan quality and shorter overall treatment time that may improve patient compliance, reduce intrafraction movement, improve clinic efficiency, and potentially offering lung SBRT treatments for underserved patients on a Halcyon only clinic.

PMID:35128795 | DOI:10.1002/acm2.13555

J Cosmet Dermatol. 2022 Feb 6. doi: 10.1111/jocd.14697. Online ahead of print.

ABSTRACT

BACKGROUND: With an increasing demand of aesthetic soft-tissue filler treatments, the occurrence of adverse events rises likewise. An optimized injection algorithm adapted to product characteristics (eg, rheology) of the soft-tissue filler is crucial in order to ensure satisfying clinical outcomes and high patient safety.

OBJECTIVE: To identify a subjective feedback mechanism for the avoidance of adverse events after soft-tissue filler injection procedures.

METHODS: A retrospective data analysis of n = 387 aesthetic treatments performed on n = 291 patients (4 males, 287 females) with different soft-tissue fillers with regard to loss of volume (filling effect), injected layer, injectability (“ease of injection”), injected volume, and injection technique was conducted.

RESULTS: The subjectively perceived injectability during the injection process was statistically significantly related to G-Prime value with r_s = 0.101 with p = 0.048, indicating an increased difficulty while injecting products with higher G-Prime. The occurrence of adverse events was also statistically significantly related to the injectability: injections with increased subjectively perceived difficulty showed increasing odds of developing adverse events by OR 0.157 with p = 0.002.

CONCLUSION: Injections that were subjectively more difficult to perform are more likely to develop adverse events. Respecting the layered arrangement of the face, the recommended and approved depth and facial region for each specific treatment enable practitioners to achieve satisfying outcomes while keeping the rate of adverse events low.

PMID:35128773 | DOI:10.1111/jocd.14697

Trop Med Int Health. 2022 Feb 6. doi: 10.1111/tmi.13731. Online ahead of print.

ABSTRACT

OBJECTIVES: To analyze the spatial distribution of rates of COVID-19 cases and its association with socioeconomic conditions in the state of Pernambuco, Brazil.

METHODS: Autocorrelation (Moran Index) and spatial association (Geographically Weighted Regression) models were used to explain the interrelationships between municipalities and the possible effects of socioeconomic factors on rates.

RESULTS: Two isolated clusters were revealed in the inner part of the state in sparsely inhabited municipalities. The spatial model (Geographically Weighted Regression) was able to explain 50% of the variations in COVID-19 cases. The variables proportion of people with low income, percentage of rented homes, percentage of families in social programs, Gini index and running water had the greatest explanatory power for the increase in infection by COVID-19.

CONCLUSIONS: Our results provide important information on socioeconomic factors related to the spread of COVID-19 and can serve as a basis for decision-making in similar circumstances.

PMID:35128767 | DOI:10.1111/tmi.13731

J Magn Reson Imaging. 2022 Feb 7. doi: 10.1002/jmri.28098. Online ahead of print.

ABSTRACT

BACKGROUND: Quantitative imaging studies of the pancreas have often targeted the three main anatomical segments, head, body, and tail, using manual region of interest strategies to assess geographic heterogeneity. Existing automated analyses have implemented whole-organ segmentation, providing overall quantification but failing to address spatial heterogeneity.

PURPOSE: To develop and validate an automated method for pancreas segmentation into head, body, and tail subregions in abdominal MRI.

STUDY TYPE: Retrospective.

SUBJECTS: One hundred and fifty nominally healthy subjects from UK Biobank (100 subjects for method development and 50 subjects for validation). A separate 390 UK Biobank triples of subjects including type 2 diabetes mellitus (T2DM) subjects and matched nondiabetics.

FIELD STRENGTH/SEQUENCE: A 1.5 T, three-dimensional two-point Dixon sequence (for segmentation and volume assessment) and a two-dimensional axial multiecho gradient-recalled echo sequence.

ASSESSMENT: Pancreas segments were annotated by four raters on the validation cohort. Intrarater agreement and interrater agreement were reported using Dice overlap (Dice similarity coefficient [DSC]). A segmentation method based on template registration was developed and evaluated against annotations. Results on regional pancreatic fat assessment are also presented, by intersecting the three-dimensional parts segmentation with one available proton density fat fraction (PDFF) image.

STATISTICAL TEST: Wilcoxon signed rank test and Mann-Whitney U-test for comparisons. DSC and volume differences for evaluation. A P value < 0.05 was considered statistically significant.

RESULTS: Good intrarater (DSC mean, head: 0.982, body: 0.940, tail: 0.961) agreement and interrater (DSC mean, head: 0.968, body: 0.905, tail: 0.943) agreement were observed. No differences (DSC, head: P = 0.4358, body: P = 0.0992, tail: P = 0.1080) were observed between the manual annotations and our method’s segmentations (DSC mean, head: 0.965, body: 0.893, tail: 0.934). Pancreatic body PDFF was different between T2DM and nondiabetics matched by body mass index.

DATA CONCLUSION: The developed segmentation’s performance was no different from manual annotations. Application on type 2 diabetes subjects showed potential for assessing pancreatic disease heterogeneity.

LEVEL OF EVIDENCE: 4 TECHNICAL EFFICACY STAGE: 3.

PMID:35128748 | DOI:10.1002/jmri.28098

J Magn Reson Imaging. 2022 Feb 7. doi: 10.1002/jmri.28100. Online ahead of print.

ABSTRACT

BACKGROUND: Epicardial adipose tissue (EAT) may induce left atrium (LA) wall inflammation and promote LA fibrosis. Therefore, simultaneous assessment of these two important atrial fibrillation (AF) risk factors would be desirable.

PURPOSE: To perform a comprehensive evaluation of 3D Dixon water-fat separated late gadolinium enhancement (LGE-Dixon) MRI by analysis of repeatability and systematic comparison with reference methods for assessment of fibrosis and fat.

STUDY TYPE: Prospective.

POPULATION: Twenty-eight, 10, and 7 patients, respectively, with clinical indications for cardiac MRI.

FIELD STRENGTH/SEQUENCE: A 1.5-T scanner, inversion recovery multiecho spoiled gradient echo.

ASSESSMENT: Twenty-eight patients (age 58 ± 19 years, 15 males) were scanned using LGE-Dixon. A 5-point Likert-type scale was used to grade the image quality. Another 10 patients (age 46 ± 19 years, 9 males) were scanned using LGE-Dixon and 3D proton density Dixon (PD-Dixon). Finally, seven patients (age 62 ± 14 years, 4 males) were scanned using LGE-Dixon and conventional LGE. The scan time, intraobserver and interobserver variability, and levels of agreement were assessed.

STATISTICAL TESTS: Student’s t-test, one-way ANOVA, and Mann-Whitney U-test were used; P < 0.05 was considered significant, intraclass correlation coefficient (ICC).

RESULTS: The scan time (minutes:seconds) for LGE-Dixon (n = 28) was 5:01 ± 1:40. ICC values for intraobserver and interobserver measurements of LA wall fibrosis percentage were 0.98 (95% CI, 0.97-0.99) and 0.97 (95% CI, 0.94-0.99) while of EAT were 0.92 (95% CI, 0.82-0.97) and 0.90 (95% CI, 0.80-0.95). The agreement for LA fibrosis percentage between the LGE-Dixon and the conventional LGE was 0.92 (95% CI, 0.66-0.99) and for EAT volume between the LGE-Dixon and the PD-Dixon was 0.93 (95% CI, 0.72-0.98).

CONCLUSION: LA fibrosis and EAT can be assessed simultaneously using LGE-Dixon. This method allows a high level of intraobserver and interobserver repeatability as well as agreement with reference methods and can be performed in a clinically feasible scan time.

EVIDENCE LEVEL: 2 TECHNICAL EFFICACY STAGE: 3.

PMID:35128754 | DOI:10.1002/jmri.28100

J Adv Nurs. 2022 Feb 7. doi: 10.1111/jan.15171. Online ahead of print.

ABSTRACT

AIM: To describe Australian registered nurses’ awareness, and implementation of reasonable adjustments within their practice when caring for people with intellectual disability and/or autism. Additionally, the association between key demographic, workforce, and respondent variables and familiarity of the term and regularity of use was explored.

DESIGN: Cross-sectional survey.

METHODS: Survey data were collected between August and October 2020 using an online survey tool. Data were analysed using descriptive and inferential statistics.

RESULTS: Familiarity of the concept of reasonable adjustments was relatively low, compared to respondents who report applying adjustments when caring for people with intellectual disability and/or autism. Higher levels of confidence, comfort, and knowledge when caring for this cohort were associated with greater awareness and application of reasonable adjustments.

CONCLUSION: A higher volume, and diversity in type of, nursing education related to care for people with intellectual disability and/or autism is indicated.

PMID:35128714 | DOI:10.1111/jan.15171

Health Soc Care Community. 2022 Feb 6. doi: 10.1111/hsc.13737. Online ahead of print.

ABSTRACT

Most people living with dementia want to continue living in their own home for as long as possible and many rely on support from homecare services to do so. There are concerns that homecare often fails to meet the needs of clients with dementia, but there is limited evidence regarding effective interventions to improve its delivery for this client group. We aimed to assess whether a co-designed, 6-session dementia training intervention for homecare workers (NIDUS-professional) was acceptable and feasible. Facilitated training sessions were delivered over 3 months, followed by 3, monthly implementation meetings to embed changes in practice. Two trained and supervised facilitators without clinical qualifications delivered the intervention via group video-calls during Oct 2020-March 2021 to a group of seven homecare workers from one agency in England. Participants provided qualitative feedback 3- and 6-months post intervention. Qualitative interview data and facilitator notes were integrated in a thematic analysis. Adherence to the intervention and fidelity of delivery were high, indicating that it was acceptable and feasible to deliver in practice. Thirty of a possible 42 (71.4%) group sessions were attended. In our thematic analysis we report one over-arching theme: ‘Having time and space to reflect is a rare opportunity’. Within this we identified four subthemes (Having time to reflect is a rare opportunity; Reflecting with peers enhances learning; Reflection and perspective taking can improve care; Recognising skills and building confidence) through which we explored how participants valued the intervention to discuss their work and learn new skills. Attendance was lower for the implementation sessions, perhaps reflecting participants’ lack of clarity about their purpose. We used our findings to consider how we can maintain positive impacts of the manualised sessions, so that these are translated into tangible, scalable benefits for people living with dementia and the homecare workforce. A randomised feasibility trial is underway.

PMID:35128740 | DOI:10.1111/hsc.13737

J Med Virol. 2022 Feb 6. doi: 10.1002/jmv.27640. Online ahead of print.

ABSTRACT

AIM: The aim of this study was to investigate the change in Nuclear Factor Erythroid 2-related factor (Nrf2), which plays a critical role in cytoprotection against oxidative stress, in paediatric patients with COVID-19 infection positivity, and to evaluate the relationship between Nrf2 and oxidative balance.

METHODS: The study included 40 children with confirmed COVID-19 infection and 35 healthy children. The groups were compared in respect of Nrf2, total oxidant status (TOS), total antioxidant status (TAS) and oxidative stress index (OSI), in addition to clinical findings of fever, cough shortness of breath, and contact history, and demographic data of age and gender.

RESULTS: The mean Nrf2 values and TAS levels were determined to be statistically significantly low (p<0.001) and the TOS level and OSI were statistically significantly high in the children with COVID-19 compared to the control group. A significant positive correlation was determined between Nrf2 and TAS (p<0.01); as the Nrf2 value increased, so the TAS value increased. A significant negative correlation was determined between Nrf2 and TOS and OSI (p<0.01); as the Nrf2 value increased, there was determined to be a significant decrease in the TOS and OSI values.

CONCLUSION: COVID-19 infection in paediatric patients causes a decrease in Nrf2 level. By causing a decrease in TAS level and an increase in TOS and OSI levels, the decrease in Nrf2 may explain the tissue damage which can be caused by COVID-19. This article is protected by copyright. All rights reserved.

PMID:35128704 | DOI:10.1002/jmv.27640

Psychophysiology. 2022 Feb 6:e14003. doi: 10.1111/psyp.14003. Online ahead of print.

ABSTRACT

The error-related negativity (ERN) and the error positivity (Pe) are electrophysiological components associated with error processing that are thought to exhibit distinctive developmental trajectories from childhood to adulthood. To investigate the age and age moderation effects on the ERN and the Pe strength during development, we conducted a preregistered three-level meta-analysis synthesizing 120 and 41 effect sizes across 18 group comparison studies and 19 correlational studies, respectively. The meta-analysis included studies with mean age between 3.6 and 28.7 (min-max age range: 3.5 and 49.8) years for age-group comparisons and 6.1 to 18.7 (min-max age range: 4.0-35.7) years for age correlations. Results showed that age was associated with a more negative ERN (SMD = -.433, r = -.230). No statistically significant association between age and the Pe was found (SMD = .059, r = -.091), except for in a group comparison between younger and older adolescents. The age effects were not significantly moderated by whether a Flanker or a Go/No-Go task was used, whereas a probabilistic learning task moderated the age effect on the Pe. Moreover, the Fz and Cz electrode sites yielded stronger negative associations between age and the ERN and the Pe, respectively. The results confirm that the ERN and the Pe show differential development courses and suggest that sample and methodological characteristics influence the age effects, and lay the foundation for investigations of developmental patterns of the ERN and the Pe in relation to psychopathology and early genetic and environmental risk factors.

PMID:35128651 | DOI:10.1111/psyp.14003