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Nevin Manimala Statistics

Increasing Adherence to Prophylactic Swallowing Exercises During Head and Neck Radiotherapy: The Multicenter, Randomized Controlled PRESTO-Trial

Dysphagia. 2022 Sep 19. doi: 10.1007/s00455-022-10513-6. Online ahead of print.

ABSTRACT

BACKGROUND: Prophylactic swallowing exercises (PSE) during radiotherapy can significantly reduce dysphagia after radiotherapy in head and neck cancer (HNC). However, its positive effects are hampered by low adherence rates during the burdensome therapy period. Hence, the main goal of this multicenter randomized controlled trial (RCT) was to investigate the effect of 3 different service-delivery modes on actual patients’ adherence.

METHODS: A total of 148 oropharyngeal cancer patients treated with primary (chemo)radiotherapy were randomly assigned to a 4 weeks PSE program, either diary-supported (paper group; n = 49), app-supported (app group; n = 49) or therapist-supported (therapist group; n = 50). Participants practiced 5 days/week, daily alternating tongue strengthening exercises with chin tuck against resistance exercises. Adherence was measured as the percentage of completed exercise repetitions per week (%reps). Statistical analysis was performed by means of SPSSv27, using Linear Mixed-effects Models with post hoc pairwise testing and Bonferroni-Holm correction.

RESULTS: Adherence and evolution of adherence over time was significantly different between the three groups (p < .001). Adherence rates decreased in all three groups during the 4 training weeks (p < .001). During all 4 weeks, the therapist group achieved the highest adherence rates, whilst the app group showed the lowest adherence rates.

CONCLUSIONS: PSE adherence decreased during the first 4 radiotherapy weeks regardless of group, but with a significant difference between groups. The therapist group achieved the highest adherence rates with a rather limited decline, therefore, increasing the face-to-face contact with a speech-language therapist can overcome the well-known problem of low adherence to PSE in this population.

TRIAL REGISTRATION: Trial registration: ISRCTN, ISRCTN98243550. Registered December 21, 2018 – retrospectively registered, https://www.isrctn.com/ISRCTN98243550?q=gwen%20van%20nuffelen&filters=&sort=&offset=1&totalResults=2&page=1&pageSize=10&searchType=basic-search .

PMID:36121560 | DOI:10.1007/s00455-022-10513-6

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Nevin Manimala Statistics

The quality of diagnostic studies used for the diagnostic criteria of periprosthetic joint infections

Eur J Orthop Surg Traumatol. 2022 Sep 19. doi: 10.1007/s00590-022-03386-w. Online ahead of print.

ABSTRACT

BACKGROUND: Although periprosthetic joint infection (PJI) is a serious complication following a total joint arthroplasty procedure, there remains uncertainty regarding the diagnosis of PJI due to the lack of a globally accepted, standardized definition. The goal of this review is to critically analyze the quality of the evidence used for the novel 2018 MSIS PJI definition and identify gaps and limitations with using the Quality Assessment of Diagnostic Accuracy Studies (QUADAS-2) tool.

METHODS: References from the modified 2018 MSIS definition for PJI by Parvizi et al. were retrieved and manually reviewed. A total of 11 studies were assessed using a validated QUADAS-2 tool.

RESULTS: Many included studies had an unclear or high risk of bias for the Index Test domain due to a lack of blinding and lack of prespecified thresholds. A majority of studies utilized Youden’s J statistic to optimize the thresholds which may diminish external validity. Likewise, several studies were assessed to have an unclear and high risk of bias for the Flow and Timing domain primarily due to a lack of reporting and a large number of exclusions. Overall, there was a low risk of bias for the choice of reference standard, its conduct and interpretation, as well as for the Patient Selection domain.

CONCLUSION: Although the literature used for the MSIS 2018 PJI definition is fraught with potential sources of bias, there may be a trend toward an improvement in the quality of evidence when compared to the earlier definition of PJI.

PMID:36121542 | DOI:10.1007/s00590-022-03386-w

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Nevin Manimala Statistics

Statistical shape modelling of the thoracic spine for the development of pedicle screw insertion guides

Biomech Model Mechanobiol. 2022 Sep 19. doi: 10.1007/s10237-022-01636-8. Online ahead of print.

ABSTRACT

Spinal fixation and fusion are surgical procedures undertaken to restore stability in the spine and restrict painful or degenerative motion. Malpositioning of pedicle screws during these procedures can result in major neurological and vascular damage. Patient-specific surgical guides offer clear benefits, reducing malposition rates by up to 25%. However, they suffer from long lead times and the manufacturing process is dependent on third-party specialists. The development of a standard set of surgical guides may eliminate the issues with the manufacturing process. To evaluate the feasibility of this option, a statistical shape model (SSM) was created and used to analyse the morphological variations of the T4-T6 vertebrae in a population of 90 specimens from the Visible Korean Human dataset (50 females and 40 males). The first three principal components, representing 39.7% of the variance within the population, were analysed. The model showed high variability in the transverse process (~ 4 mm) and spinous process (~ 4 mm) and relatively low variation (< 1 mm) in the vertebral lamina. For a Korean population, a standardised set of surgical guides would likely need to align with the lamina where the variance in the population is lower. It is recommended that this standard set of surgical guides should accommodate pedicle screw diameters of 3.5-6 mm and transverse pedicle screw angles of 3.5°-12.4°.

PMID:36121529 | DOI:10.1007/s10237-022-01636-8

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Nevin Manimala Statistics

Quantifying the Effect of Sex and Neuroanatomical Biomechanical Features on Brain Deformation Response in Finite Element Brain Models

Ann Biomed Eng. 2022 Sep 19. doi: 10.1007/s10439-022-03084-y. Online ahead of print.

ABSTRACT

Recent automotive epidemiology studies have concluded that females have significantly higher odds of sustaining a moderate brain injury or concussion than males in a frontal crash after controlling for multiple crash and occupant variables. Differences in neuroanatomical features, such as intracranial volume (ICV), have been shown between male and female subjects, but how these sex-specific neuroanatomical differences affect brain deformation is unknown. This study used subject-specific finite element brain models, generated via registration-based morphing using both male and female magnetic resonance imaging scans, to investigate sex differences of a variety of neuroanatomical features and their effect on brain deformation; additionally, this study aimed to determine the relative importance of these neuroanatomical features and sex on brain deformation metrics for a single automotive loading environment. Based on the Bayesian linear mixed models, sex had a significant effect on ICV, white matter volume and gray matter volume, as well as a section of cortical gray matter regions’ thicknesses and volumes; however, after these neuroanatomical features were accounted for in the statistical model, sex was not a significant factor in predicting brain deformation. ICV had the highest relative effect on the brain deformation metrics assessed. Therefore, ICV should be considered when investigating both brain injury biomechanics and injury risk.

PMID:36121528 | DOI:10.1007/s10439-022-03084-y

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Nevin Manimala Statistics

Multilevel non-contiguous thoracic pedicle subtraction osteotomy for fixed rounded hyperkyphotic deformity of the thoraco-lumbar junction with anterior bony fusion: technical note

J Orthop Traumatol. 2022 Sep 19;23(1):47. doi: 10.1186/s10195-022-00665-4.

ABSTRACT

BACKGROUND: Fixed severe hyperkyphotic deformities spread over more than five vertebral levels represent a therapeutic challenge, especially when the deformity apex is located at the thoraco-lumbar junction, thus requiring a huge amount of correction. The aim of this article is to describe an innovative all-posterior corrective technique based on multilevel non-contiguous thoracic pedicle subtraction ostoeotomy (PSO).

MATERIALS AND METHODS: A retrospective review of three patients with fixed severe thoracic hyperkyphosis (a deformity angle of over 70°) with a thoraco-lumbar apex (between T11 and L1) treated by simultaneous two-level thoracic PSO and thoraco-lumbar posterior fusion was performed. Radiographic and clinical records were evaluated pre-operatively, post-operatively and at last follow-up (after a minimum of 2 years). Each variable was presented as mean ± SD (standard deviation). Statistical analyses were performed using paired t-tests (P value < 0.05 was considered significant).

RESULTS: The mean local deformity angle decreased by 75% (from 81.3° ± 2.1° to 20.7° ± 1.4°, p < 0.001), the post-operative thoracic kyphosis decreased by 46% (from 61.4° ± 2.4° to 33.2° ± 0.9°, p < 0.001) and the sagittal vertical axis decreased by 73% (from 14.7 cm ± 0.8 cm to 3.9 cm ± 0.3 cm, p < 0.001). No differences were observed in the radiological results between post-operative values and those at the final follow-up. The average Oswestry Disability Index (ODI) score reduced from 65.7 ± 1.8 pre-operatively to 17.3 ± 1.7 at last follow-up (p < 0.001). No neurological, mechanical nor infective complication occurred.

CONCLUSIONS: The presented technique, although technically demanding, proved to be a safe and effective alternative for the management of fixed severe thoraco-lumbar junction hyperkyphotic deformities.

LEVEL OF EVIDENCE: IV TRIAL REGISTRATION Retrospectively registered.

PMID:36121524 | DOI:10.1186/s10195-022-00665-4

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Nevin Manimala Statistics

Spatial distribution and ecological risk assessment of heavy metals in surface sediments from the northern Bohai Strait, China

Environ Monit Assess. 2022 Sep 19;194(11):802. doi: 10.1007/s10661-022-10470-5.

ABSTRACT

The epicontinental seas to the east of China have become highly anthropogenically impacted due to rapid economic development in recent decades, resulting in various environmental problems, including heavy metal pollution. The Bohai Strait, as a key junction connecting the material-energy exchange between the Bohai and Yellow Seas, is extremely critical in regional pollution prevention and control. To ascertain the spatial distribution and contamination levels of heavy metals in the surface sediments of the northern Bohai Strait, a systematic investigation was conducted. Geochemical analysis revealed that the concentrations (in ppm) of heavy metal elements in surface sediments vary in the range of 4.19-77.6 for As, 0.04-0.21 for Cd, 5.1-65.7 for Pb, 0.30-39.40 for Cu, 7.77-46.50 for Ni, 1.50-86.60 for Cr, 11.70-91.80 for Zn, and 0.005-0.038 for Hg. Ecological statistics indicate that the northern Bohai Strait suffers from prominent heavy metal pollution primarily induced by As, Cd, and Pb, accompanied by relatively weak pollution of Cu and Ni. Sediments collected from the submarine depressions and the southeast region exhibit higher heavy metal concentrations, and as a consequence, more serious ecological risk. Correlation analysis indicated that the accumulations of Hg, Cr, and Zn were associated with the deposition of organic matter. Preliminary provenance discrimination suggested that the pollutants were mainly derived from the eastern parts of the North Yellow Sea, rather than the Bohai region.

PMID:36121518 | DOI:10.1007/s10661-022-10470-5

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Nevin Manimala Statistics

Time-Scale Analysis and Parameter Fitting for Vector-Borne Diseases with Spatial Dynamics

Bull Math Biol. 2022 Sep 19;84(11):124. doi: 10.1007/s11538-022-01083-7.

ABSTRACT

Vector-borne diseases are progressively spreading in a growing number of countries, and it has the potential to invade new areas and habitats. From the dynamical perspective, the spatial-temporal interaction of models that try to adjust to such events is rich and challenging. The first challenge is to address the dynamics of vectors (very fast and local) and the dynamics of humans (very heterogeneous and non-local). The objective of this work is to use the well-known Ross-Macdonald models, identifying different time scales, incorporating human spatial movements and estimate in a suitable way the parameters. We will concentrate on a practical example, a simplified space model, and apply it to dengue spread in the state of Rio de Janeiro, Brazil.

PMID:36121515 | DOI:10.1007/s11538-022-01083-7

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Nevin Manimala Statistics

Development and evaluation of deep-learning measurement of leg length discrepancy: bilateral iliac crest height difference measurement

Pediatr Radiol. 2022 Sep 19. doi: 10.1007/s00247-022-05499-0. Online ahead of print.

ABSTRACT

BACKGROUND: Leg length discrepancy (LLD) is a common problem that can cause long-term musculoskeletal problems. However, measuring LLD on radiography is time-consuming and labor intensive, despite being a simple task.

OBJECTIVE: To develop and evaluate a deep-learning algorithm for measurement of LLD on radiographs.

MATERIALS AND METHODS: In this Health Insurance Portability and Accountability Act (HIPAA)-compliant retrospective study, radiographs were obtained to develop a deep-learning algorithm. The algorithm developed with two U-Net models measures LLD using the difference between the bilateral iliac crest heights. For performance evaluation of the algorithm, 300 different radiographs were collected and LLD was measured by two radiologists, the algorithm alone and the model-assisting method. Statistical analysis was performed to compare the measurement differences with the measurement results of an experienced radiologist considered as the ground truth. The time spent on each measurement was then compared.

RESULTS: Of the 300 cases, the deep-learning model successfully delineated both iliac crests in 284. All human measurements, the deep-learning model and the model-assisting method, showed a significant correlation with ground truth measurements, while Pearson correlation coefficients and interclass correlations (ICCs) decreased in the order listed. (Pearson correlation coefficients ranged from 0.880 to 0.996 and ICCs ranged from 0.914 to 0.997.) The mean absolute errors of the human measurement, deep-learning-assisting model and deep-learning-alone model were 0.7 ± 0.6 mm, 1.1 ± 1.1 mm and 2.3 ± 5.2 mm, respectively. The reading time was 7 h and 12 min on average for human reading, while the deep-learning measurement took 7 min and 26 s. The radiologist took 74 min to complete measurements in the deep-learning mode.

CONCLUSION: A deep-learning U-Net model measuring the iliac crest height difference was possible on teleroentgenograms in children. LLD measurements assisted by the deep-learning algorithm saved time and labor while producing comparable results with human measurements.

PMID:36121497 | DOI:10.1007/s00247-022-05499-0

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Nevin Manimala Statistics

The relationship between perceived stress and depressive symptoms in adolescents during high stress: The moderating role of emotion regulation

J Adolesc. 2022 Sep 19. doi: 10.1002/jad.12091. Online ahead of print.

ABSTRACT

INTRODUCTION: This study examined the moderating role of adaptive and maladaptive emotion regulation in the relationship between general perceived stress and depressive symptoms during the first coronavirus disease 2019 (COVID-19) lockdown in March-April 2020 in Belgium, while controlling for past depressive symptoms in 2016.

METHODS: Participants were 110 adolescents (55% female; Mage = 16, SDage = 1.80) who filled out different questionnaires assessing maladaptive and adaptive emotion regulation strategies (ERS), perceived stress, and depressive symptoms.

RESULTS: Results revealed that only maladaptive ERS statistically significantly moderated the relationship between perceived stress and depressive symptoms. More specifically, the amount of perceived stress is positively associated with the level of depressive symptoms, especially in adolescents who use more maladaptive ERS.

CONCLUSION: The repertoire of adaptive ERS might not be sufficient for adolescents to flexibly cope with a highly stressful situation such as the COVID-19 pandemic and lockdown. Study findings highlight the need to support youth, particularly those who use more maladaptive ERS, in adaptively coping with intense stressful life events.

PMID:36120954 | DOI:10.1002/jad.12091

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Nevin Manimala Statistics

Bounded-width confidence interval following optimal sequential analysis of adverse events with binary data

Stat Methods Med Res. 2022 Sep 18:9622802221122383. doi: 10.1177/09622802221122383. Online ahead of print.

ABSTRACT

In sequential testing with binary data, sample size and time to detect a signal are the key performance measures to optimize. While the former should be optimized in Phase III clinical trials, minimizing the latter is of major importance in post-market drug and vaccine safety surveillance of adverse events. The precision of the relative risk estimator on termination of the analysis is a meaningful design criterion as well. This paper presents a linear programming framework to find the optimal alpha spending that minimizes expected time to signal, or expected sample size as needed. The solution enables (a) to bound the width of the confidence interval following the end of the analysis, (b) designs with outer signaling thresholds and inner non-signaling thresholds, and (c) sequential designs with variable Bernoulli probabilities. To illustrate, we use real data on the monitoring of adverse events following the H1N1 vaccination. The numerical results are obtained using the R Sequential package.

PMID:36120901 | DOI:10.1177/09622802221122383