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Nevin Manimala Statistics

Social inequalities in mobility during and following the COVID-19 associated lockdown of the Madrid metropolitan area in Spain

Health Place. 2021 May 19;70:102580. doi: 10.1016/j.healthplace.2021.102580. Online ahead of print.

ABSTRACT

Spain has been one of the most affected regions by the COVID-19 worldwide, and Madrid its most affected city. In response to this, the Spanish government enacted a strict lockdown in late March 2020, that was gradually eased until June 2020. We explored differentials in mobility by area-level deprivation in the functional area of Madrid, before, during, and after the COVID-19 lockdown. We used cell phone-derived mobility indicators (% of the population leaving their area) from the National Institute of Statistics (INE), and a composite measure of deprivation from the Spanish Society of Epidemiology (SEE). We computed changes in mobility with respect to pre-pandemic levels, and explored spatial patterns and associations with deprivation. We found that levels of mobility before COVID-19 were slightly higher in areas with lower deprivation. The economic hibernation period resulted in very strong declines in mobility, most acutely in low deprivation areas. These differences weakened during the re-opening, and levels of mobility were similar by deprivation once the lockdown was completely lifted. Given the existence of important socioeconomic differentials in COVID-19 exposure, it is key to ensure that these interventions do not widen existing social inequalities.

PMID:34022543 | DOI:10.1016/j.healthplace.2021.102580

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Preexisting cardiorespiratory comorbidity does not preclude the success of multidisciplinary rehabilitation in post-COVID-19 patients

Respir Med. 2021 May 15;184:106470. doi: 10.1016/j.rmed.2021.106470. Online ahead of print.

ABSTRACT

Patients recovering from coronavirus disease 2019 (COVID-19) may not return to a pre-COVID functional status and baseline levels of healthcare needs after discharge from acute care hospitals. Since the long-term outcomes of COVID-19 can be more severe in patients with underlying cardiorespiratory diseases, we aimed at verifying the impact of a preexisting cardiorespiratory comorbidity on multidisciplinary rehabilitation in post-COVID-19 patients. We enrolled 95 consecutive patients referring to the Pulmonary Rehabilitation Unit of Istituti Clinici Scientifici Maugeri Spa SB, IRCCS of Telese Terme, Benevento, Italy after being discharged from the COVID-19 acute care ward and after recovering from acute COVID-19 pneumonia. Forty-nine of them were not suffering from underlying comorbidities, while 46 had a preexisting cardiorespiratory disease. Rehabilitation induced statistically significant improvements in respiratory function, blood gases and the ability to exercise both in patients without any preexisting comorbidities and in those with an underlying cardiorespiratory disease. Response to the rehabilitation cycle tended to be greater in those without preexisting comorbidities, but DLco%-predicted was the only parameter that showed a significant greater improvement when compared to the response in the group of patients with underlying cardiorespiratory comorbidity. This study suggests that multidisciplinary rehabilitation may be useful in post-COVID-19 patients regardless of the presence of preexisting cardiorespiratory comorbidities.

PMID:34022502 | DOI:10.1016/j.rmed.2021.106470

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Predicting local tumour progression after ablation for colorectal liver metastases: CT-based radiomics of the ablation zone

Eur J Radiol. 2021 May 12;141:109773. doi: 10.1016/j.ejrad.2021.109773. Online ahead of print.

ABSTRACT

PURPOSE: To assess whether CT-based radiomics of the ablation zone (AZ) can predict local tumour progression (LTP) after thermal ablation for colorectal liver metastases (CRLM).

MATERIALS AND METHODS: Eighty-two patients with 127 CRLM were included. Radiomics features (with different filters) were extracted from the AZ and a 10 mm periablational rim (PAR)on portal-venous-phase CT up to 8 weeks after ablation. Multivariable stepwise Cox regression analyses were used to predict LTP based on clinical and radiomics features. Performance (concordance [c]-statistics) of the different models was compared and performance in an ‘independent’ dataset was approximated with bootstrapped leave-one-out-cross-validation (LOOCV).

RESULTS: Thirty-three lesions (26 %) developed LTP. Median follow-up was 21 months (range 6-115). The combined model, a combination of clinical and radiomics features, included chemotherapy (HR 0.50, p = 0.024), cT-stage (HR 10.13, p = 0.016), lesion size (HR 1.11, p = <0.001), AZ_Skewness (HR 1.58, p = 0.016), AZ_Uniformity (HR 0.45, p = 0.002), PAR_Mean (HR 0.52, p = 0.008), PAR_Skewness (HR 1.67, p = 0.019) and PAR_Uniformity (HR 3.35, p < 0.001) as relevant predictors for LTP. The predictive performance of the combined model (after LOOCV) yielded a c-statistic of 0.78 (95 %CI 0.65-0.87), compared to the clinical or radiomics models only (c-statistic 0.74 (95 %CI 0.58-0.84) and 0.65 (95 %CI 0.52-0.83), respectively).

CONCLUSION: Combining radiomics features with clinical features yielded a better performing prediction of LTP than radiomics only. CT-based radiomics of the AZ and PAR may have potential to aid in the prediction of LTP during follow-up in patients with CRLM.

PMID:34022475 | DOI:10.1016/j.ejrad.2021.109773

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Thoracic Bone Mineral Density measured by Quantitative Computed Tomography in Patients undergoing Spine Surgery

Spine J. 2021 May 19:S1529-9430(21)00254-0. doi: 10.1016/j.spinee.2021.05.016. Online ahead of print.

ABSTRACT

BACKGROUND CONTEXT: The thoracic spine is a common location for vertebral fractures as well as instrumentation failure after long spinal fusion procedures. The association between those complications and bone mineral density (BMD) are well recognized. Due to the overlying sternum and ribs in the thoracic spine, projectional BMD assessment tools such as dual energy x-ray absorptiometry (DXA) are limited to the lumbar spine. Quantitative computed tomography circumvents several shortcomings of DXA and allows for level-specific BMD measurements. Studies comprehensively quantifying BMD of the entire thoracic spine in patients undergoing spine surgery are limited.

PURPOSE: The objective of this study was: 1) to assess the reliability of thoracic QCT measurements, 2) to determine possible level-specific BMD variation throughout the thoracic spine and 3) to assess the correlation between BMDs of the T1-T12 spinal levels.

STUDY DESIGN/SETTING: Cross-sectional observation study.

PATIENT SAMPLE: Patients undergoing spine surgery from 2016-2020 at a single, academic institution with available preoperative CT imaging of the thoracic spine were included in this study.

OUTCOME MEASURES: The outcome measure was BMD measured by QCT.

METHODS: Patients undergoing spine surgery from 2016-2020 at a single, academic institution with available preoperative CT imaging of the thoracic spine were included in this study. Subjects with previous instrumentation at any thoracic level, concurrent vertebral fractures, a Cobb angle of more than 20 degrees, or incomplete thoracic spine CT imaging were excluded. Asynchronous quantitative computed tomography (QCT) measurements of T1-T12 were performed. To assess inter- and intra-observer reliability, a validation study was performed on 120 vertebrae in 10 randomly selected patients. The interclass correlation coefficient (ICC) was calculated. A pairwise comparison of BMD was conducted and correlations between each thoracic level were evaluated. The statistical significance level was set at p<0.05.

RESULTS: 60 patients (men, 51.7%) met inclusion criteria. The study population was 90% Caucasian with a mean age of 62.2 years and a mean BMI of 30.2 kg/m2. The inter- and intra-observer reliability of the thoracic QCT measurements was excellent (ICC of 0.97 and 0.97, respectively). The trabecular BMD was highest in the upper thoracic spine and decreased in the caudal direction (T1 = 182.3 mg/cm3, T2 = 168.1 mg/cm3, T3 = 163.5 mg/cm3, T4 = 164.7 mg/cm3, T5 = 161.4 mg/cm3, T6 = 152.5 mg/cm3, T7 = 143.5 mg/cm3, T8 = 141.3 mg/cm3, T9 = 143.5 mg/cm3, T10 = 145.1 mg/cm3, T11 = 145.3 mg/cm3, T12 = 133.6 mg/cm3). The BMD of all thoracic levels cranial to T6 was statistically higher than the BMD of all levels caudal to T6 (p < 0.001). Nonetheless, significant correlations in BMD among all measured thoracic levels were observed, with a Pearson’s correlation coefficient ranging from 0.74 to 0.97.

CONCLUSIONS: There is significant regional BMD variation in the thoracic spine depending on spinal level. This BMD variation might contribute to several clinically relevant phenomena. First, vertebral fractures occur most commonly at the thoracolumbar junction including T12. In addition to mechanical reasons, these fractures might be partially attributed to thoracic BMD that is lowest at T12. Second, the optimal upper instrumented vertebra (UIV) for stopping long fusions to the sacrum and pelvis is controversial. The BMD of surgically relevant upper thoracic stopping points (T2-T4) was significantly higher than the BMD of lower thoracic stopping points (T10-T12). Besides stress concentration at the relatively mobile lower thoracic segments, the low BMD at these levels might contribute to previously suggested higher rates of junctional failures with short fusions.

PMID:34022462 | DOI:10.1016/j.spinee.2021.05.016

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Improving cognitive functions in adolescents with learning difficulties: A feasibility study on the potential use of telerehabilitation during Covid-19 pandemic in Italy

J Adolesc. 2021 May 19;89:194-202. doi: 10.1016/j.adolescence.2021.05.005. Online ahead of print.

ABSTRACT

INTRODUCTION: Learning disabilities are due to genetic and/or neurobiological factors that alter brain functioning by affecting one or more cognitive processes related to learning. This study aimed to assess the efficacy of cognitive telerehabilitation in adolescents with learning disabilities to overcome the treatment problems related to the COVID-19 pandemic lockdown.

METHODS: Twenty-four patients diagnosed with Unspecified Learning Disability (mean ± SD age: 18.2 ± 2.9 years; 50% male) were enrolled in this study. The patients were assessed by a neuropsychological evaluation at the beginning and at the end of the program. All patients received cognitive treatment via a specific telehealth app to stimulate the cognitive skills related to learning. The treatment lasted four weeks, with a daily training (lasting up to 60 min), for five days a week.

RESULTS: Our young patients reported a statistically significant improvement in the main cognitive domains that are usually compromised in learning disabilities, including sustained and selective attention, shifting of attention, control of interference, memory and speed of information processing. Moreover, the patients showed a good usability and motivation during the training.

CONCLUSIONS: Our study has shown that telerehabilitation could be a valid tool for the rehabilitation of specific cognitive skills in adolescents with learning difficulties.

PMID:34022448 | DOI:10.1016/j.adolescence.2021.05.005

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Comparing the effectiveness of mother’s live lullaby and recorded lullaby on physiological responses and sleep of preterm infants: a clinical trial study

J Complement Integr Med. 2021 May 24. doi: 10.1515/jcim-2020-0507. Online ahead of print.

ABSTRACT

OBJECTIVES: Environmental stimuli in neonatal intensive care units can disrupt the physiological stability and sleep of infants. It is essential to perform nursing interventions to reduce the adverse effects of such stimuli. This study aimed to compare the effect of recorded lullabies and mothers’ live lullabies on physiological responses and sleep duration of preterm infants.

METHODS: This study was a randomized clinical trial. The participants were 90 preterm infants selected using convenience sampling. In the intervention groups, music (recorded lullabies and mother’s live lullabies) was played for 14 days, 20 min a day, while the control group did not receive any intervention. The data were collected using physiological criteria and infant sleep checklists before, during, and after the intervention. The data were analyzed using SPSS software (Version 21.0).

RESULTS: The mean scores of physiological parameters (O2 saturation and heart rate) were not significantly different in the three groups before, during, and after the intervention (p>0.05). However, there was an improvement in O2-saturation and a decrease in the heart rate in two intervention groups. The mean duration of the infants’ overnight sleep was not statistically significant between the groups before the intervention (p>0.05). However, there was a statistically significant difference in the intervention groups after the intervention, (p<0.05), and the infants’ overnight sleep was longer in the recorded-lullaby group than the other two groups.

CONCLUSIONS: Although performing interventions, including recorded lullaby and mother’s live lullaby did not differ significantly with that of the control group in physiological criteria, it can be clinically important. In addition, recorded-lullaby increased the infants’ overnight sleeping. Thus, it is suggested that further studies be conducted to confirm the effect of recorded lullaby and mother’s live lullaby interventions on physiological parameters and sleep duration of hospitalized infants.

PMID:34022122 | DOI:10.1515/jcim-2020-0507

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Factors influencing participation rates in clinical late-effect studies of childhood cancer survivors

Pediatr Blood Cancer. 2021 May 22:e29098. doi: 10.1002/pbc.29098. Online ahead of print.

ABSTRACT

To ensure external validation of a study population in clinical late-effect studies of childhood cancer, the participation rate must be high. This study investigated demographic data in Nordic late-effect studies and potential factors impacting participation rates such as cancer type, time since diagnosis, and duration of clinical examinations. We found 80 published studies originating from 16 cohorts, with median follow-up of 6.0 years (range 3-14). The overall participation rates ranged from 27% to 100%. The highest participation rates were seen in studies of survivors with solid tumors (92%) and the lowest in hematologic malignancies (67%) and central nervous system tumors (73%). The clinical examination in 10 studies (62.5%) lasted for more than 3 hours. Neither duration of the clinical examination nor time since diagnosis seemed to affect the participation rate. We encourage future studies to describe the recruitment process more thoroughly to improve understanding of the factors influencing participation rates.

PMID:34022113 | DOI:10.1002/pbc.29098

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Naxitamab combined with granulocyte-macrophage colony-stimulating factor as consolidation for high-risk neuroblastoma patients in complete remission

Pediatr Blood Cancer. 2021 May 22:e29121. doi: 10.1002/pbc.29121. Online ahead of print.

ABSTRACT

BACKGROUND: Naxitamab is a humanized anti-disialoganglioside (GD2) monoclonal antibody approved for treatment of bone/bone marrow refractory high-risk neuroblastoma (HR-NB). Compassionate use (CU) expanded access program at Hospital Sant Joan de Deu permitted treatment of patients in complete remission (CR). We here report the survival, toxicity, and relapse pattern of patients in first or second CR treated with naxitamab and sargramostim (GM-CSF).

PROCEDURE: Seventy-three consecutive patients with HR-NB (stage M at age >18 months or MYCN-amplified stages L1/L2 at any age) were treated in first or second CR. Treatment comprised five cycles of subcutaneous (SC) GM-CSF for 5 days at 250 μg/m2 /day (days -4 to 0), followed by naxitamab + SC GM-CSF for 5 days at 500 μg/m2 /day (days 1-5). Naxitamab was infused over 30 minutes at 3 mg/kg/day, days 1, 3, and 5, outpatient.

RESULTS: Fifty-five patients were in first CR and 18 in second CR. Seventeen patients had MYCN-amplified NB and 11 detectable minimal residual disease in the bone marrow. Fifty-eight (79.5%) patients completed therapy. Four (5%) experienced grade 4 toxicities and 10 (14%) early relapse. Three-year event-free survival (EFS) 58.4%, 95% CI = (43.5%, 78.4%) and overall survival (OS) 82.4%, 95% CI = (66.8%, 100%). First CR patients 3-year EFS 74.3%, 95% CI = (62.7%, 88.1%), and OS 91.6%, 95% CI = (82.4%, 100%). EFS is significantly different between first and second CR (p = .0029). The pattern of relapse is predominantly (75%) of an isolated organ, mainly bone (54%). Univariate Cox models show prior history of relapse as the only statistically significant predictor of EFS but not OS.

CONCLUSIONS: Consolidation with naxitamab and GM-CSF resulted in excellent survival rates for HR-NB patients in CR.

PMID:34022112 | DOI:10.1002/pbc.29121

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A review of cannabidiol-containing electronic liquids – current regulations and labelling accuracy

Drug Test Anal. 2021 May 22. doi: 10.1002/dta.3102. Online ahead of print.

ABSTRACT

The use of cannabidiol in electronic liquids (e-liquids) is becoming increasingly widespread and the current regulations enforced onto nicotine-containing e-liquids are not applicable to cannabidiol-based products. This has led to concerns about the quality of cannabidiol vapes. Articles investigating the reliability of product labelling were reviewed using systematic review criteria. Of 70 e-liquids, 77.1% of the e-liquids tested in the articles were found to have under- or over-estimated the cannabidiol quantities stated in the product labelling. Statistical analysis confirmed that there was a significant difference between the labelled and analysed cannabidiol concentrations (p < 0.05, Mann-Whitney U and Wilcoxon Signed Rank). Inaccuracies in received cannabidiol dosages could lead to an increased risk of adverse reactions or limit the therapeutic effect received, highlighting the benefit of enforcing specific regulations on cannabidiol-based e-liquids to protect consumer safety and guarantee product efficacy.

PMID:34022104 | DOI:10.1002/dta.3102

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Socioeconomic disparities in survival after high-risk neuroblastoma treatment with modern therapy

Pediatr Blood Cancer. 2021 May 22:e29127. doi: 10.1002/pbc.29127. Online ahead of print.

ABSTRACT

BACKGROUND: Modern therapeutic advances in high-risk neuroblastoma have improved overall survival (OS), but it is unclear whether these survival gains have been equitable. This study examined the relationship between socioeconomic status (SES) and overall survival (OS) in children with high-risk neuroblastoma and whether SES-associated disparities have changed over time.

PROCEDURE: In this population-based cohort study, children <18 years diagnosed with high-risk neuroblastoma (diagnosis at age ≥12 months with metastatic disease) from 1991 to 2015 were identified through the National Cancer Institute’s Surveillance, Epidemiology, and End Results database. Associations of county-level SES variables and OS were tested with univariate Cox proportional hazards regression. For a subcohort diagnosed after 2007, insurance status was examined as an individual-level SES variable. Multivariable regression analyses with treatment era and interaction terms were performed when SES variables reached near-significance (p ≤ .1) in univariate and bivariate modeling with treatment era.

RESULTS: Among 1217 children, 2-year OS improved from 53.0 ± 3.4% in 1991-1998 to 76.9 ± 2.9% in 2011-2015 (p < .001). In univariate analyses, children in high-poverty counties (hazard ratio [HR] = 1.74, 95% confidence interval [CI] = 1.17-2.60, p = .007), and those with Medicaid (HR = 1.40, 95% CI = 1.05-1.86, p = .02) experienced an increased hazard of death. No interactions between treatment era and SES variables were statistically significant in multivariable analyses, indicating that differences in the OS between SES groups did not change over time.

CONCLUSIONS: Survival disparities among children with high-risk neuroblastoma have not widened over time, suggesting equitable access to and benefit from therapeutic advances. However, children of low SES experience persistently inferior survival. Interventions to narrow this disparity are paramount.

PMID:34022098 | DOI:10.1002/pbc.29127