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Safety and Efficacy of Pegteograstim on Chemotherapy-induced Neutropenia in Children and Adolescents With Solid Tumors

J Pediatr Hematol Oncol. 2021 May 19. doi: 10.1097/MPH.0000000000002206. Online ahead of print.

ABSTRACT

PURPOSE: Pegteograstim (Neulapeg) is a recombinant human granulocyte colony-stimulating factor conjugated with methoxy-maleimide-polyethylene glycol. We conducted a single-arm study investigating its safety and noninferiority to conventional filgrastim in children and adolescents.

MATERIALS AND METHODS: Patients younger than 21 years with solid tumors were eligible for the study. Pegteograstim was administered on day 7 of the fourth chemotherapy cycle. Toxicities were monitored, and the change in absolute neutrophil count was compared with that of the historic control (conventional filgrastim). This trial was registered at ClinicalTrials.gov as NCT02787876.

RESULTS: Thirty-two patients were enrolled. Adverse events possibly related to pegteograstim were musculoskeletal pain (n=3), skin nodule (n=1), paroxysmal cough (n=1), urticaria (n=2), rash (n=1), and itching (n=1). These adverse events were all grade 1 or 2. Duration of neutropenia (ANC<500/µL) was shorter in the pegteograstim group compared with the historic control (median 6.5 vs. 10 d, P=0.004). The time from day 0 to neutrophil recovery (ANC>500/µL) was shorter in the pegteograstim group (median 15 vs. 18 d, P=0.003).

CONCLUSIONS: Pegteograstim is safe and shows comparable efficacy to conventional filgrastim in children and adolescents. Randomized controlled trials are needed to confirm its safety and efficacy.

PMID:34010932 | DOI:10.1097/MPH.0000000000002206

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Longitudinal Milestone Assessment Extending Through Subspecialty Training: The Relationship Between ACGME Internal Medicine Residency Milestones and Subsequent Pulmonary and Critical Care Fellowship Milestones

Acad Med. 2021 May 18. doi: 10.1097/ACM.0000000000004165. Online ahead of print.

ABSTRACT

PURPOSE: The Accreditation Council for Graduate Medical Education (ACGME) milestones were implemented across medical subspecialties in 2015. Although milestones were proposed as a longitudinal assessment tool potentially providing opportunities for early implementation of individualized learning plans in fellowship, the association of subspecialty fellowship ratings with prior residency ratings remains unclear. This study aimed to assess the relationship between internal medicine (IM) residency milestones and pulmonary-critical care medicine (PCCM) fellowship milestones.

METHOD: A multicenter retrospective cohort analysis was conducted for all PCCM trainees enrolled in ACGME-accredited PCCM fellowship programs in 2017-2018 who had complete prior IM milestone ratings from 2014-2017. Only professionalism and interpersonal and communication skills (ICS) were included based on shared anchors between IM and PCCM milestones. Using a generalized estimating equations model, the association of PCCM milestones ≤ 2.5 during the first year of fellowship with corresponding IM subcompetencies was assessed at each time-point, nested by program. Statistical significance was determined using logistic regression.

RESULTS: The study included 354 unique PCCM fellows. For both ICS and professionalism subcompetencies, fellows with higher IM ratings were less likely to obtain PCCM ratings ≤ 2.5 during the first fellowship year. Each ICS subcompetency was significantly associated with future lapses in fellowship (ICS01: β = -0.67, P = 0.003; ICS02: β = -0.70, P = 0.001; ICS03: β = -0.60, P = 0.004) at various residency timepoints. Similar associations were noted for PROF03 (β = -0.57, P = 0.007).

CONCLUSIONS: Findings demonstrated an association between IM milestone ratings and low milestone ratings during PCCM fellowship. IM trainees with low ratings in several professionalism and ICS subcompetencies were more likely to be rated ≤ 2.5 during their first year in PCCM fellowship. This highlights a potential use of longitudinal milestones to target educational gaps at the beginning of PCCM fellowship.

PMID:34010863 | DOI:10.1097/ACM.0000000000004165

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Complications after Functional Neck Dissection in Head and Neck Cancer Patients: An Observational, Retrospective, Single-Centre Study

ORL J Otorhinolaryngol Relat Spec. 2021 May 19:1-9. doi: 10.1159/000514459. Online ahead of print.

ABSTRACT

INTRODUCTION: Functional neck dissection (FND) represents a surgical procedure usually associated with less morbidity.

METHODS: An observational, retrospective, analysis of patients diagnosed with any type of head and neck malignancy was designed to summarize and report the incidence of postoperative complications in patients undergoing FND including just those levels described for selective neck dissections in a tertiary university hospital between June 2016 and June 2019.

RESULTS: 131 patients met the inclusion criteria. The total number of sides studied was 200. 40.5% of the patients suffer a complication in the postoperative period, being the spinal accessory nerve (SAN) injury the most common complication (10%). We did not find any statistical -correlation between the previous organ-preservation treatments and surgical complications (p = 0.207). An advanced T stage (p = 0.009) and the need of bilateral FND (p = 0.034) were significantly correlated with a higher risk of surgical complications.

CONCLUSION: FND represents a useful technique. In this study, 40.5% of the patients suffer a complication in the postoperative period, being the SAN injury the most common complication. However, these data contribute to increasing our knowledge about surgical complications related to FND.

PMID:34010845 | DOI:10.1159/000514459

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Mirabegron versus Solifenacin in Children with Overactive Bladder: Prospective Randomized Single-Blind Controlled Trial

Urol Int. 2021 May 19:1-7. doi: 10.1159/000515992. Online ahead of print.

ABSTRACT

PURPOSE: The purpose of this study is to investigate the efficacy and safety of mirabegron versus solifenacin in the treatment of newly diagnosed overactive bladder (OAB) in children.

METHODS: We conducted a prospective randomized controlled study on pediatric patients with newly diagnosed OAB. Patients were randomized into 3 groups: mirabegron (50 mg once daily) in group I, solifenacin (5 mg) in group II, and placebo in group III. Before starting our treatment and at the end of the 3 months course, we obtained a 3-day voiding diary. This diary included incontinence episode per day, mean voided volume per micturition, mean number of micturition per day, and post-void residual urine. Moreover, the parents/patients were asked to rate symptom relief, and the adverse events were recorded throughout the study period.

RESULTS: A total of 190 patients aged from 5 to 14 years completed this study. At the end of this trial, both groups I and II showed significant improvement versus placebo regarding our efficacy parameters with no significant difference between group I and II. The overall success rate based on assessment of symptom relief was significantly higher in the treated groups (87.5% in I and 90.2% in II) versus placebo (55.8%). Dry mouth was reported in 2.8, 10, and 0% and constipation in 2.8, 11.4, and 1.4% in group I, II, and III, respectively, without statistically significant difference between group I and placebo. However, there was a significant difference between group II and placebo regarding these side effects.

CONCLUSION: Both mirabegron and solifenacin have comparable efficacy regarding the control of OAB symptoms in the newly diagnosed children, but mirabegrone seems to have less side effects.

PMID:34010843 | DOI:10.1159/000515992

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Influence of Pediatric Endoscopic Endonasal Skull Base Resections on Midface and Skull Base Development

Pediatr Neurosurg. 2021 May 19:1-12. doi: 10.1159/000516236. Online ahead of print.

ABSTRACT

OBJECTIVE: The purpose of this study is to use imaging data to determine if endoscopic endonasal surgery (EES) for skull base tumor resection interrupts skull base growth and development, resulting in an atrophic midface skeletal structure, compared to matched normal controls.

METHODS: Data were collected by a retrospective chart review done on children aged 16 years and below who underwent endoscopic tumor resection and had pre- and postoperative magnetic resonance imaging with relevant midface anatomy. 121 normal controls were matched to 20 EES patients by age and gender. Three measurements related to midface anatomy were taken from 1 sagittal T1 slice and 1 axial T2 slice of each scan. Statistical analysis was used to compare growth measures between cases and controls.

RESULTS: Twenty patients who underwent EES between November 2015 and April 2018 met our inclusion criteria. The mean age of the patients, 11 males and 9 females, was 10 years, and 8 patients (38%) were aged 7 years or younger. Six patients who had a high-flow CSF leak obtained a nasoseptal flap. A student T test and multivariate regression analysis found that EES did not affect midface and skull base growth. Among the variables assessed, age appears to be the only driver of growth.

CONCLUSION: There were no identified differences in craniofacial growth in pediatric patients undergoing EES for skull base tumor resection as compared to the control group. EES does not appear to significantly interfere with midface/skull base development and is a good surgical option for pediatric patients.

PMID:34010830 | DOI:10.1159/000516236

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Deep learning model for distinguishing novel coronavirus from other chest related infections in X-ray images

Comput Biol Med. 2021 Apr 21;134:104401. doi: 10.1016/j.compbiomed.2021.104401. Online ahead of print.

ABSTRACT

Novel Coronavirus is deadly for humans and animals. The ease of its dispersion, coupled with its tremendous capability for ailment and death in infected people, makes it a risk to society. The chest X-ray is conventional but hard to interpret radiographic test for initial diagnosis of coronavirus from other related infections. It bears a considerable amount of information on physiological and anatomical features. To extract relevant information from it can occasionally become challenging even for a professional radiologist. In this regard, deep-learning models can help in swift, accurate and reliable outcomes. Existing datasets are small and suffer from the balance issue. In this paper, we prepare a relatively larger and well-balanced dataset as compared to the available datasets. Furthermore, we analyze deep learning models, namely, AlexNet, SqueezeNet, DenseNet201, MobileNetV2 and InceptionV3 with numerous variations such as training the models from scratch, fine-tuning without pre-trained weights, fine-tuning along with updating pre-trained weights of all layers, and fine-tuning with pre-trained weights along with applying augmentation. Our results show that fine-tuning with augmentation generates best results in pre-trained models. Finally, we have made architectural adjustments in MobileNetV2 and InceptionV3 models to learn more intricate features, which are then merged in our proposed ensemble model. The performance of our model is statistically analyzed against other models using four different performance metrics with paired two-sided t-test on 5 different splits of training and test sets of our dataset. We find that it is statistically better than its competing methods for the four metrics. Thus, the computer-aided classification based on the proposed model can assist radiologists in identifying coronavirus from other related infections in chest X-rays with higher accuracy. This can help in a reliable and speedy diagnosis, thereby saving valuable lives and mitigating the adverse impact on the socioeconomics of our community.

PMID:34010794 | DOI:10.1016/j.compbiomed.2021.104401

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The effect of umbilical cord blood spexin, free 25(OH) vitamin D3 and adipocytokine levels on intrauterine growth and anthropometric measurements in newborns

Cytokine. 2021 May 16;144:155578. doi: 10.1016/j.cyto.2021.155578. Online ahead of print.

ABSTRACT

Spexin is a newly described peptide and is known to reduce the uptake of long-chain fatty acids into adipocytes. The serum spexin levels of obese children between the ages of 12-18 are lower. The effect of serum spexin and free 25(OH) vitamin D3 levels on intrauterine development in newborns is unknown. Our aims is to evaluate the effects of spexin and adipocytokin levels in the cord blood of term newborn babies on the weight of the baby according to the gestation age (GA) and anthropometric measurement results. Babies who were born in our hospital and whose GA was ≥37 weeks were evaluated in three groups as appropriate for GA (AGA), small for GA (SGA) and large for GA (LGA). A total of 84 babies, including an equal number of infants in AGA, SGA and LGA groups, were included in the study. Spexin, leptin, active ghrelin, free 25(OH) vitamin D3, glucose, and insulin levels in the cord blood of infants were examined at birth. The results were compared according to GA and birth weight (BW). There was no statistically significant difference between groups in terms of mean spexin, active ghrelin, free 25(OH) vitamin D3, and insulin levels. The mean leptin level was significantly higher in LGA group than SGA and AGA groups (p 0.004). The mean spexin and leptin levels were higher in girls than in boys (respectively p value 0.029, 0.003). Although there is a significant positive correlation between BW, head circumference, height, umbilical circumference, umbilical circumference/height ratio and the mean leptin levels (p < 0.001), there was no significant correlation between mean spexin, active ghrelin, free 25 (OH) vitamin D3, insulin, and glucose levels. This study suggests that spexin may not have an effect on intrauterine development.

PMID:34010726 | DOI:10.1016/j.cyto.2021.155578

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Correcting the Fundamentals of Laparoscopic Surgery (FLS) “illusion of validity” in laparoscopic vaginal cuff suturing

J Minim Invasive Gynecol. 2021 May 16:S1553-4650(21)00224-7. doi: 10.1016/j.jmig.2021.05.002. Online ahead of print.

ABSTRACT

STUDY OBJECTIVE: The “illusion of validity” is a cognitive bias in which the ability to interpret and predict surgical performance accurately is overestimated. To address this bias, we assessed participants comparing FLS and non FLS tasks to cadaveric vaginal cuff suturing in order to determine the most representative simulation task for laparoscopic vaginal cuff suturing.

DESIGN: Validity (Messick Framework) study comparing FLS and non-FLS tasks to cadaveric vaginal cuff suturing.

SETTING: Simulation center cadaver lab PARTICIPANTS: : Obstetrics and gynecology residents (n=21), minimally invasive gynecologic surgery fellows (n=3), gynecologic surgical subspecialists (n=4), general obstetrician/gynecologists (n=10).

INTERVENTIONS: Tasks included a simulated vaginal cuff (ipsilateral port placement), needle passage through a metal eyelet loop (contralateral and ipsilateral), and intracorporeal knot tying (contralateral and ipsilateral). Simulation task times were compared to the placement of the first cadaveric vaginal cuff suture time, as well as the in-person and blinded Global Operative Assessment of Laparoscopic Skills (GOALS) score (“relations to other variables” validity evidence). Statistical analyses included Spearman’s test of correlation (continuous and ordinal variables) or Wilcoxon rank sum test (categorical variables).

MEASUREMENTS AND MAIN RESULTS: There was a stronger association with cadaver cuff suturing time for simulated vaginal cuff suturing time (r: 0.73, P<0.001) compared to FLS intracorporeal contralateral suturing time (r: 0.54, P<0.001). Additional measures associated with cadaveric performance included subspecialty training (Median: 82 vs. 185 seconds, P=0.002), number of total laparoscopic hysterectomies (r: -0.53, P<0.001), number of laparoscopic cuff closures (r: -0.61, P<0.001), number of simulated laparoscopic suturing experiences (r: -0.51, P<0.001), and eyelet contralateral time (r: 0.52, P<0.001). Strong agreement between the in-person and blinded GOALS (ICC=0.80) supports response process evidence. Correlations of cadaver cuff time with in-person (Spearman’s r: -0.84, P<0.001), and blinded GOALS (r: -0.76, P<0.001) supports relations to other variables evidence CONCLUSION: : The weaker correlation between FLS suturing and cadaver cuff suturing compared to a simulated vaginal cuff model may lead to an “illusion of validity” for assessment in gynecology. Since gynecology specific validity evidence has not been well established for FLS, we recommend prioritizing the use of a simulated-vaginal cuff suturing assessment in addition to FLS.

PMID:34010696 | DOI:10.1016/j.jmig.2021.05.002

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Are Instagram posts related to #Wisdomteeth useful for patient education?

J Stomatol Oral Maxillofac Surg. 2021 May 16:S2468-7855(21)00117-8. doi: 10.1016/j.jormas.2021.05.007. Online ahead of print.

ABSTRACT

OBJECTIVES: This study aims to assess the quality of the posts about wisdom teeth on Instagram in terms of patients benefit.

METHODS AND MATERIALS: The #Wisdomteeth hashtag was searched on Instagram. The first 200 posts were reviewed. 50 posts were included in this study. Upload sources were categorized as health care professionals, health companies and individuals users. Post types were categorized as patient’s experience, educational and scientifically erroneous. The posts were evaluated under eight titles for evaluating the usefulness score. The usefulness scores of the posts were classified as poor, moderate and excellent. Kruskal-Wallis test and Chi2 test was used for data. Significance level was accepted as P < 0.05 RESULTS: The usefulness score was between 0 and 2, with a mean of 0.16. There were no statistically significant differences between upload sources and usefulness score (p=0.328). There were no statistically significant differences between the usefulness score and the number of comments (p=0.126).

CONCLUSION: The results of the study showed that Instagram posts do not contain reliable information for patients.

PMID:34010672 | DOI:10.1016/j.jormas.2021.05.007

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Prevalence, clinical profile, and stroke risk of atrial fibrillation in rural Andhra Pradesh, India (The AP-AF study) – Rationale and design

Indian Pacing Electrophysiol J. 2021 May 16:S0972-6292(21)00079-6. doi: 10.1016/j.ipej.2021.05.003. Online ahead of print.

ABSTRACT

INTRODUCTION: The epidemiology of atrial fibrillation (AF) in India has not been studied systematically in large scale population based surveys. Stroke is one of the leading causes of death and disability in India. As AF is a major contributor of stroke, it is important to know the burden of AF and stroke risk in the population. The Andhra Pradesh Atrial Fibrillation (AP-AF) study aims to assess the prevalence, etiology, risk factors and stroke risk among the rural population in Andhra Pradesh, India.

METHODS: This is a cross-sectional survey done using a two-stage sampling process. Adults (≥18years) from villages in East and West Godavari districts were sampled. Field investigators used a structured questionnaire to collect information on basic demographics, cardiovascular risk factors and medical history. Anthropometric measurements were performed, blood pressure measured and fasting capillary blood glucose was assessed. Electrocardiogram was done using a hand-held mobile ECG device-KardioMobile. ECGs were interpreted by study cardiologists. Participants diagnosed to have AF were invited to participate in a camp conducted by cardiologists where echocardiogram was done and also a focused history related to AF was collected. Along with age and sex stratified prevalence of AF, descriptive statistics will be used to present demographics, clinical profile, and cardiovascular risk factors. Stroke risk will be calculated using CHA 2 DS 2 -Vasc score.

CONCLUSION: The AP-AF study is expected to provide important information on AF epidemiology in rural India. The information may help improve health care policies in preventing stroke and other complications of AF.

PMID:34010662 | DOI:10.1016/j.ipej.2021.05.003