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Nevin Manimala Statistics

Efficacy of Buzzy Device Versus EMLA Cream for Reducing Pain During Needle-Related Procedures in Children: A Randomized Controlled Trial

Pediatr Emerg Care. 2023 May 11. doi: 10.1097/PEC.0000000000002965. Online ahead of print.

ABSTRACT

OBJECTIVES: Several pain management tools exist but with limitations in their efficacy or applicability. The EMLA (eutectic mixture of local anesthetics) cream is currently used for pain relief for needle-related procedures; however, it needs a minimum of 30 to 45 minutes to be effective. The Buzzy is a device that generates vibrations with cold leading to quicker pain relief. Our aim was to evaluate the effect of the Buzzy device in pain and anxiety reduction compared with EMLA cream in children requiring intravenous cannulation or venepuncture.

METHODS: This was a randomized clinical trial comparing pain and anxiety reduction by Buzzy device with the standard care (EMLA cream) in children aged 2 to 14 years who required blood extraction or intravenous cannulation based on their clinical needs. Eligible patients were randomized to either Buzzy device as the intervention or EMLA cream as the control. The outcome measures were the degree of pain scores and anxiety ratings at different stages of the needle-related procedures.

RESULTS: A total of 300 patients with a mean age of 6.5 ± 3.1 years were enrolled. Baseline characteristics were similar between the Buzzy device and EMLA cream groups. The observed pain scores by research nurses and a parent were significantly lower in the EMLA group compared with the Buzzy device group; however, the pain scores by the self-assessment scale were not statistically significant with mean difference of -0.332, 95% confidence interval, -0.635 to -0.028 (P = 0.062). The level of anxiety was significantly lower in EMLA compared with Buzzy device (P = 0. 0.0001). Both staff and parents’ satisfaction, success rate of cannulation, type of blood tests, and comment on the physician on the results were similar in both groups.

CONCLUSIONS: Pain and anxiety relief using the Buzzy device is not as effective as EMLA cream in children requiring venepuncture. However, rapid onset of action of the Buzzy device is valuable in decreasing waiting time in a busy emergency department.

TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT05354739.

PMID:37163686 | DOI:10.1097/PEC.0000000000002965

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Nevin Manimala Statistics

Semi-Empirical Shadow Molecular Dynamics: A PyTorch Implementation

J Chem Theory Comput. 2023 May 10. doi: 10.1021/acs.jctc.3c00234. Online ahead of print.

ABSTRACT

Extended Lagrangian Born-Oppenheimer molecular dynamics (XL-BOMD) in its most recent shadow potential energy version has been implemented in the semiempirical PyTorch-based software PySeQM. The implementation includes finite electronic temperatures, canonical density matrix perturbation theory, and an adaptive Krylov subspace approximation for the integration of the electronic equations of motion within the XL-BOMB approach (KSA-XL-BOMD). The PyTorch implementation leverages the use of GPU and machine learning hardware accelerators for the simulations. The new XL-BOMD formulation allows studying more challenging chemical systems with charge instabilities and low electronic energy gaps. The current public release of PySeQM continues our development of modular architecture for large-scale simulations employing semi-empirical quantum-mechanical treatment. Applied to molecular dynamics, simulation of 840 carbon atoms, one integration time step executes in 4 s on a single Nvidia RTX A6000 GPU.

PMID:37163680 | DOI:10.1021/acs.jctc.3c00234

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Nevin Manimala Statistics

The Effect of Developmental Delay and Autism Spectrum Disorder on External Auditory Canal Foreign Body Extraction

Pediatr Emerg Care. 2023 May 11. doi: 10.1097/PEC.0000000000002960. Online ahead of print.

ABSTRACT

OBJECTIVES: To determine the effect of developmental delay (DD) and autism spectrum disorder (ASD) on pediatric external auditory canal foreign body (EAC FB) retrieval outcomes.

METHODS: A retrospective chart review of children presenting with EAC FB at a tertiary children’s hospital was performed between January 2018 and December 2019. Charts were reviewed for demographics, presence of otalgia, complications, number of EAC FB episodes, indications for operating room removal, DD, and ASD status.

RESULTS: A total of 1467 patients underwent EAC FB removal. One hundred thirty-seven children (9.3%) had DD, and, of those with DD, 63 (46%) had ASD. Children with DD were 1.76 years older compared with children with non-DD (NDD) (P < 0.0001) at the time of presentation, whereas children with ASD were 1.45 years older than children with NDD (P = 0.0023). Children with DD and ASD were more likely to require removal of FB in the operating room (OR) compared with the NDD group (36.5% vs 16.7%, P = 0.0001). This was not true for children with DD without ASD. Patients with DD reported significantly less otalgia when compared with NDD patients (26.3% vs 37.4%, P = 0.0097). A similar trend, although not statistically significant, was observed when comparing children with ASD with NDD patients. The NDD patients (1.1) had fewer EAC FB episodes than patients with DD (1.6, P < 0.0001) and ASD (1.8, P < 0.0016). Hazard ratios for multiple episodes of FB were 4.5 (95% confidence interval, 2.9-6.8) for DD, and 5.6 for ASD (95% confidence interval, 3.2-9.9). The complication rate for all groups was low.

CONCLUSIONS: Due to the different ways that children with DD and ASD present compared with NDD children, physicians should be vigilant when evaluating symptoms and conducting physical examinations for EAC FB in those patients. A lower threshold for referral to otolaryngologists may result in more favorable outcomes.

PMID:37163677 | DOI:10.1097/PEC.0000000000002960

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Nevin Manimala Statistics

Asynchronous Learning Module for Pediatric Emergency Medicine Physicians on How to Manage Vaginal Birth and Neonatal Resuscitation in the Emergency Department

Pediatr Emerg Care. 2023 May 11. doi: 10.1097/PEC.0000000000002959. Online ahead of print.

ABSTRACT

OBJECTIVES: Newborn deliveries and neonatal resuscitation events are rare but essential skills for pediatric emergency medicine (PEM) physicians. We sought to evaluate the effect of an online module on PEM physicians’ knowledge and confidence in managing newborn deliveries and neonatal resuscitation.

METHODS: A team of experts in PEM, obstetrics, neonatology, and medical education developed a self-directed, 1-hour online module on managing newborn deliveries with neonatal resuscitation. The module was designed to address the learning needs of the targeted group. The module was piloted before dissemination to PEM faculty. A 10-question multiple choice test was given to assess knowledge of the material covered. A 10-point Likert scale questions survey was used to evaluate confidence. Measures were administered before initiation, after module completion, and 6 months after completion. Paired t tests were used to compare mean knowledge scores, and rank sum tests were used to compare median confidence levels.

RESULTS: Most (n = 47, 89%) of the PEM faculty members completed the module. The majority (n = 43, 91%) thought the information was relevant to their practice. After completing the module, physicians’ overall knowledge scores improved by 18% (mean [SD]: 74% [14.7] vs 92% [8.0], P < 0.01). Self-assessed confidence improved after the module in terms of managing uncomplicated vaginal deliveries (median 5 vs 7, P < 0.01), care of patients with complicated vaginal deliveries (2 vs 5, P < 0.01), and managing neonatal resuscitation (7 vs 8, P < 0.01). During the 6-month follow-up, there was sustained improvement in physicians’ overall knowledge score (82% [16.9], P = 0.007) and self-assessed confidence in managing complicated vaginal deliveries (median 2 vs 4, P = 0.0012); however, other measures were not statistically significant.

CONCLUSIONS: An online module is an appropriate method for training PEM providers about rarely used but essential skills such as managing vaginal deliveries and neonatal resuscitation.

PMID:37163676 | DOI:10.1097/PEC.0000000000002959

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A Randomized, Multicenter, Evaluator-blind Study to Evaluate the Safety and Effectiveness of VYC-12L Treatment for Skin Quality Improvements

Dermatol Surg. 2023 May 9. doi: 10.1097/DSS.0000000000003802. Online ahead of print.

ABSTRACT

BACKGROUND: Skin quality may be assessed by degrees of skin smoothness, fine lines, and hydration. VYC-12L is a recently developed hyaluronic acid filler to improve skin quality.

OBJECTIVE: This was a randomized, evaluator-blind study assessing safety and effectiveness of intradermal VYC-12L treatment for improving cheek skin smoothness, fine lines, and hydration.

METHODS: Participants (≥22 years) with moderate-to-severe investigator-assessed Allergan Cheek Smoothness Scale (ACSS) scores were randomized in 2:1 ratio to receive VYC-12L or control (no treatment with optional treatment). Effectiveness was assessed 1 month after last injection (initial or touch-up) by a responder rate (≥1-grade improvement from baseline on both cheeks) using investigator-rated ACSS and Allergan Fine Lines Scale (AFLS), and tissue dielectric constant probe-measured skin hydration. Safety was evaluated throughout.

RESULTS: Participants (VYC-12L, n = 131; control, n = 71) were 86.1% female with a median age of 58.0 years. At month 1, ACSS and AFLS responder rates were statistically significantly higher in the VYC-12L group (57.9%, 58.3%, respectively) than in the untreated controls (4.5%, 5.4%, respectively; p < .001). VYC-12L ACSS and AFLS responder rates remained consistent throughout the 6-month follow-up. Six participants reported treatment-related adverse events; none led to study discontinuation.

CONCLUSION: VYC-12L is an effective, well-tolerated treatment for lasting improvement of cheek skin smoothness, fine lines, and hydration.

PMID:37163665 | DOI:10.1097/DSS.0000000000003802

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How to Review a Submission to a Medical Journal

Dis Colon Rectum. 2023 May 9. doi: 10.1097/DCR.0000000000002927. Online ahead of print.

NO ABSTRACT

PMID:37163658 | DOI:10.1097/DCR.0000000000002927

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Nevin Manimala Statistics

Blue light therapy in the management of chronic wounds: a narrative review of its physiological basis and clinical evidence

Wounds. 2023 May;35(5):91-98.

ABSTRACT

INTRODUCTION: Chronic wounds are a significant problem worldwide, with substantial cost to health care systems; thus, a minimally invasive and well-tolerated treatment is attractive. Blue light has shown promise in wound healing through the principle of photobiomodulation.

OBJECTIVE: This review examines the physiological effects of blue light on tissue and the hypothesis that appropriate application of blue light in conjunction with SOC improves wound healing compared with SOC alone.

METHODS: The authors searched in PubMed, Google Scholar, and the Cochrane Library to identify literature on the mechanism of action of blue light and then examined the clinical evidence.

RESULTS: Key physiological pathways of blue light include generation of ROS and nitric oxide, resulting in promotion of angiogenesis, reduced inflammation, and direct antimicrobial effects. These reactions are seen only at low doses; in fact, higher doses may be harmful to tissue. The only primary study with statistical analyses demonstrated wound area reduction of 51% (P =.007) in blue light-irradiated wounds compared with SOC alone.

CONCLUSIONS: Blue light applied following a strict protocol is safe and shows promise in the management of chronic wounds. The current evidence is poor, however, and randomized trials are required to confirm its clinical utility.

PMID:37163654

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Nevin Manimala Statistics

Incidence and Recurrence of Deep Spine Surgical Site Infections: A Systematic Review and meta-analysis

Spine (Phila Pa 1976). 2023 May 10. doi: 10.1097/BRS.0000000000004713. Online ahead of print.

ABSTRACT

STUDY DESIGN: Systematic review and meta-analysis.

OBJECTIVE: To determine a pooled incidence rate for deep SSI, and compare available evidence for deep surgical site infection (SSI) management among instrumented spinal fusions.

SUMMARY OF BACKGROUND DATA: Deep SSI is a common complication of instrumented spinal surgery associated with patient morbidity, poorer long-term outcomes, and higher healthcare costs.

METHODS: We systematically searched Medline and Embase, and included studies with an adult patient population undergoing posterior instrumented spinal fusion of the thoracic, lumbar or sacral spine, with a reported outcome of deep SSI. The primary outcome was the incidence of deep SSI. Secondary outcomes included persistent deep SSI following initial debridement, mean number of debridements, and microbiology. Subsequent meta-analysis combined outcomes for surgical-site infection using a random-effects model and quantified heterogeneity using the χ2 test and the I2 statistic. Additionally, qualitative analysis of management strategies was reported.

RESULTS: Of 9087 potentially eligible studies, we included 54 studies (37 comparative, 17 non-comparative). The pooled SSI incidence rate was 1.5% (95% CI, 1.1% to 1.9%) based on 209,347 index procedures. Up to 25% of patients (95% CI 16.8% to 35.3%), had a persistent infection. These patients require an average of 1.4 (range: 0.8-1.9) additional debridements. Infecting organisms were commonly gram-positive and among them, staphylococcus aureus was the most frequent (46%). Qualitative analysis suggests implant retention, especially for early deep SSI management. Evidence was limited for other management strategies.

CONCLUSIONS: The pooled incidence rate of deep SSI post-thoracolumbar spinal surgery is 1.5%. The rate of recurrence and repeat debridement is at least 12%, up to 25%. Persistent infection is a significant risk, highlighting the need for standardized treatment protocols. Our review further demonstrates heterogeneity in management strategies. Large-scale prospective studies are needed to develop better evidence around deep SSI incidence and management in the instrumented thoracolumbar adult spinal fusion population.

PMID:37163651 | DOI:10.1097/BRS.0000000000004713

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Abnormal gray matter volume and functional connectivity patterns in social cognition-related brain regions of young children with autism spectrum disorder

Autism Res. 2023 May 10. doi: 10.1002/aur.2936. Online ahead of print.

ABSTRACT

Autism spectrum disorder (ASD) is associated with abnormal brain imaging findings, but descriptions thereof are inconsistent. The aim of the present study was to investigate brain abnormalities in young children with ASD using a combination of structural and functional brain magnetic resonance imaging (MRI). Structural and resting-state functional MRI was performed in 67 children with ASD (aged 2-7 years) and 39 age-matched typically developing (TD) controls. Voxel-based morphometry was used to evaluate differences in brain structure between groups. Topologic parameters of the functional brain network were compared by graph theoretic analysis and network connectomes were compared with network-based statistics. A support vector machine (SVM) was used to discriminate between ASD and TD groups. Results demonstrated young children with ASD had increased gray matter volumes (GMVs) in the right medial superior frontal gyrus and left fusiform gyrus compared with the TD group. The ASD group had altered subnetwork connectivity in frontal and temporal lobes and other social cognition-related brain regions. Functional connectivity in the left superior temporal gyrus and left temporal pole of the middle temporal gyrus was positively correlated with adaptability and language developmental quotient (DQ) in children with ASD. The combination of the brain structural and functional features had 86.2% accuracy in discriminating between ASD and TD. The present study shows that young children with ASD have altered GMVs and functional networks in social cognition-related brain regions, which are potential neuroimaging biomarkers for ASD.

PMID:37163546 | DOI:10.1002/aur.2936

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The role of the soluble fms-like tyrosine kinase-1/placental growth factor (sFlt-1/PIGF) – ratio in clinical practice in obstetrics: diagnostic and prognostic value

J Perinat Med. 2023 May 8. doi: 10.1515/jpm-2022-0353. Online ahead of print.

ABSTRACT

OBJECTIVES: Analyze the diagnostic and prognostic value of the sFlt-1/PlGF ratio in pregnant women with at least one sign/symptom of suspected/diagnosed pre-eclampsia.

METHODS: This retrospective observational study included 170 pregnant women with at least one sign/symptom of pre-eclampsia, who had sFlt-1/PlGF ratio values. The following information was evaluated: pregnant women’s demographic data and clinical history; laboratory data (urine protein/creatinine ratio; sFlt-1/PlGF ratio); signs and symptoms presented; clinical outcome; fetal complications; data related to childbirth. Statistical analysis was performed by R Software Version 3.5.2.

RESULTS: Among the 170 patients, 78 presented pre-eclampsia. The median sFlt-1/PlGF ratio was significantly higher [143.1 (2.2-2,927.1)] for women who presented pre-eclampsia than for women without pre-eclampsia [33.5 (0.8-400.2)]. The negative predictive value of sFlt-1/PlGF ratio <38 was 83.9 % (95 % CI, 71.7-92.4 %) and the positive predictive value of sFlt-1/PlGF ratio >85 or 110 (for late onset pre-eclampsia) was 76.4 % (95 % CI, 66.2-84.8 %). sFlt-1/PlGF >85 or 110 was associated with pre-eclampsia clinical development, fetal complications, shorter gestational age at birth, higher number of caesarean deliveries and lower birth weight.

CONCLUSIONS: The sFlt-1/PlGF ratio, together with the standard diagnostic criteria, can be used to rule out pre-eclampsia, identify high-risk patients and predict the occurrence of adverse outcomes.

PMID:37163520 | DOI:10.1515/jpm-2022-0353