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Nevin Manimala Statistics

Aquablation, Prostatic Urethral Lift, and Transurethral Water Vapor Therapy: A Comparison of Device Related Adverse Events in a National Registry

J Endourol. 2021 Jul 27. doi: 10.1089/end.2021.0455. Online ahead of print.

ABSTRACT

PURPOSE: Aquablation, prostatic urethral lift (PUL), and transurethral water vapor therapy (TWVT) have demonstrated efficacy for the treatment of benign prostatic hyperplasia (BPH). Our objective was to describe device malfunctions and complications to help guide procedural selection and performance.

MATERIALS AND METHODS: The Manufacturer and User Facility Device Experience (MAUDE) database was examined for reports related to the use of these three procedures for the treatment of BPH between January 1, 2015 and July 1, 2020. Reports were evaluated for device malfunctions and surgical complications using a previously described externally validated classification system developed for the MAUDE database. Chi square analysis was used for statistical comparison between groups.

RESULTS: A total of 391 adverse events were reported: Aquablation (n=102), PUL (n=132), and TWVT (n=157). There were 79 (78%) severe or life threatening adverse events for Aquablation vs. 69 (52%) for PUL vs. 24 (15%) for TWVT (p < 0.001). There were 4 cases of rectal perforation with Aquablation and 25 cases of the PUL implants needing to be removed or causing a problem with a later procedure. Blood transfusion frequencies were: Aquablation – 32 (31%), PUL – 21 (16%), TWVT – 1 (1%). The most common device malfunctions were: Aquablation – motion error (n=8), handpiece fracture/attachment malfunction (n=8); PUL – device misfire (n=27), needle fragmentation (n=21); TWVT – unresolvable error message (n=19).

CONCLUSIONS: In a national database, Aquablation and PUL had noteworthy complications or device related malfunctions such as rectal perforation and the improper placement or failed deployment of the PUL implants. Both patients and providers should be aware of potential risks when selecting these novel BPH treatments.

PMID:34314240 | DOI:10.1089/end.2021.0455

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In-vitro comparison of two electromagnetic shock-wave generators: low-pressure-wide focus versus high-pressure small focus – the impact on initial stone fragmentation and final stone comminution

J Endourol. 2021 Jul 27. doi: 10.1089/end.2021.0416. Online ahead of print.

ABSTRACT

CONTEXT: Recently developed concepts for higher efficacy ESWL with low-pressure wide focus systems resulting in finer fragmentation of the calculi.

OBJECTIVE: To compare two different electromagnetic shock wave sources (low-pressure wide focus (XL) versus high-pressure small focus (SL)) by sound-field measurements and in-vitro fragmentation.

EVIDENCE ACQUISITION: The CS-2012A XX-ES lithotripter (self-focusing electromagnetic shock-wave generator with concave spherical curved electrical coil; Xinin Lithotripter = XL) was compared to the Siemens Lithoskop (= SL) (electromagnetic generator with a flat electric coil with an acoustical lens). Different sound-field measurements were performed using a fiber-optic hydrophone. Measurements at three different power settings (XL: 8.0kV, 9.3kV and 10.3kV; SL: Level 1, 5 and 8). 10 ATS-stones and 15 BegoStones (9.3 kV, Level 3) with a frequency of 90/minute (SL) and 20/minute (XL). Number of impulses to the first crack and for complete stone comminution (residual fragments <2mm) were documented.

RESULTS: The median number of shock waves for the first crack in ATS-stones with the XL was 12 (10-14), with the SL 7 (6-9). Complete disintegration was accomplished after 815 (782-824) shock waves with XL, 702 (688-712) with SL. The difference was not statistically significant. The median number of shock waves to produce the first crack in BegoStones was 524 (504-542) with XL and only 151 (137-161) with SL. Numbers of shock waves for complete disintegration did not differ significantly (XL:2518 vs SL:2287). Using a wide focus with low pressure shows more homogeneous disintegration.

CONCLUSION: Two stone models showed significant differences regarding form and time of the initial fragmentation. Impulses for stone comminution did not differ significantly. The advantages of a low-pressure wide focus-system include minimal trauma and a homogeneous fragment size but is more time consuming. High-pressure small focus systems are clinically effective.

PMID:34314251 | DOI:10.1089/end.2021.0416

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Early versus Late Surgical Decompression for Traumatic Spinal Cord Injury on Neurological Recovery: A Systematic Review and Meta-analysis

J Neurotrauma. 2021 Jul 27. doi: 10.1089/neu.2021.0102. Online ahead of print.

ABSTRACT

This study aimed to investigate whether early surgical decompression was associated with favourable neurological recovery in patients with traumatic spinal cord injury (tSCI). We searched PubMed and Embase from the database inception through December 2020 and selected studies comparing the impact of early versus late surgical decompression on neurological recovery as assessed by American Spinal Injury Association Impairment Scale (AIS) for adult patients sustaining tSCI. We pooled the effect estimates in random-effects models and quantified the heterogeneity by the I2 statistics. Subgroup analysis and meta-regression analysis was conducted to identify significant outcome moderator. We included 26 studies involving 3,574 patients in the meta-analysis. The pooled results demonstrated significant association between early surgical decompression and an improvement of at least one AIS grade (odds ratio [OR], 1.85; 95% confidence interval [CI], 1.41-2.41; I2, 48.06%). The benefits of early surgical decompression were consistently observed across different subgroups, including patients with cervical or thoracolumbar injury and patients with complete or incomplete injury. The meta-regression analysis indicated that cut-off timing defining early versus late decompression was a significant effect moderator, with early decompression performed before post-tSCI 8 or 12 h associated with greatest benefits (OR, 3.37; 95% CI, 1.74-6.50; I2, 53.52%). No obvious publication bias was detected by the funnel plot. In conclusion, early surgical decompression was associated with favourable neurological recovery for tSCI patients. However, there was a lack of high-quality evidence and the results need further examination.

PMID:34314253 | DOI:10.1089/neu.2021.0102

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Early literacy training among medical students

Clin Teach. 2021 Jul 27. doi: 10.1111/tct.13402. Online ahead of print.

ABSTRACT

BACKGROUND: The American Academy of Pediatrics regards literacy promotion as essential. Medical professionals are in a key position to promote children’s early literacy, however this requires knowledge of existing literacy programmes. This study describes medical student training, awareness, experiences, and attitudes towards early literacy and the ‘Reach Out and Read’ (ROR) initiative.

METHODS: An anonymous online survey was sent to all medical students at a medical school in the Midwest with two campuses. Data were analysed using descriptive statistics.

RESULTS: We received data from 275 medical students. Almost half (46.5%) had completed their paediatric clerkship, 22.9% had observed ROR, and only 2.9% had received any training. Most (67%), wanted to learn more about early literacy, and 59% expressed a desire for more ROR training. Most respondents expressed preference for learning from residents and faculty in clinic followed by online training. 47% agreed that it was a role of medical students to assess and encourage reading.

DISCUSSION: Medical students understand the importance of early literacy in primary care and emphasising this during clinical encounters. Most are eager to learn more about early literacy promotion and ROR. This interest decreases during third and fourth year so targeting the first 2 years of medical school is an important strategy. Providing formal literacy promotion training and education for medical students should be considered during this critical time in their education.

PMID:34313383 | DOI:10.1111/tct.13402

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The use of umbilical cord-derived mesenchymal stem cells in patients with muscular dystrophies: Results from compassionate use in real-life settings

Stem Cells Transl Med. 2021 Jul 27. doi: 10.1002/sctm.21-0027. Online ahead of print.

ABSTRACT

Muscular dystrophies are genetically determined progressive diseases with no cause-related treatment and limited supportive treatment. Although stem cells cannot resolve the underlying genetic conditions, their wide-ranging therapeutic properties may ameliorate the consequences of the involved mutations (oxidative stress, inflammation, mitochondrial dysfunction, necrosis). In this study, we administered advanced therapy medicinal product containing umbilical cord-derived mesenchymal stem cells (UC-MSCs) to 22 patients with muscular dystrophies. Patients received one to five intravenous and/or intrathecal injections per treatment course in up to two courses every 2 months. Four standard doses of 10, 20, 30, or 40 × 106 UC-MSCs per injection were used; the approximate dose per kilogram was 1 × 106 UC-MSCs. Muscle strength was measured with a set of CQ Dynamometer computerized force meters (CQ Elektronik System, Czernica, Poland). Statistical analysis of muscle strength in the whole group showed significant improvement in the right upper limb (+4.0 N); left hip straightening (+4.5 N) and adduction (+0.5 N); right hip straightening (+1.0 N), bending (+7.5 N), and adduction (+2.5 N); right knee straightening (+8.5 N); left shoulder revocation (+13.0 N), straightening (+5.5 N), and bending (+6.5 N); right shoulder adduction (+3.0 N), revocation (+10.5 N), and bending (+5 N); and right elbow straightening (+9.5 N); all these differences were statistically significant. In six patients (27.3%) these changes led to improvement in gait analysis or movement scale result. Only one patient experienced transient headache and lower back pain after the last administration. In conclusion, UC-MSC therapy may be considered as a therapeutic option for these patients.

PMID:34313400 | DOI:10.1002/sctm.21-0027

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La3+ and F- dual-doped multifunctional hydroxyapatite nanoparticles: Synthesis and characterization

Microsc Res Tech. 2021 Jul 27. doi: 10.1002/jemt.23880. Online ahead of print.

ABSTRACT

Hydroxyapatite (HA) co-doped with La3+ and F ions were synthesized by the precipitation method and sintered at 1,100°C for 1 hr. Samples were characterized by the standard experimental methods including the density, X-Ray Diffraction (XRD), Fourier Transform Infrared Spectroscopy (FTIR), and Scanning Electron Microscopy (SEM) to investigate their microstructure, phase formation, and bonding characteristics in detail. Moreover, the materials produced were identified using the microhardness tests. It was observed that in the most of materials, the hydroxyapatite was found to be the main phase with a minor amount of β-tricalcium phosphate (β-TCP). Furthermore, the presence of fluoride and small amount of β-TCP was verified with all the characteristic FTIR bands of hydroxyapatite for the majority of samples studied. The result in SEM evaluation is that the produced HA powders have less deformed, uniformly distributed, and regularly shaped particles. Here, the material density has changed towards a less dense state with the increasing rate of La doping, but statistically significant difference was not obtained (p, .1942 > .05) with increase of the F doping. A significant difference was obtained the microhardness values between La3+ and F ions co-doped HA materials and pure HA (p [.0053] < .05). Accordingly, this study confirmed that since the La3+ and F ions can potentially increase the efficacy of HA. According to the spectral, mechanical, and microstructure analysis result, this material can be as a good candidate product for use as an occluding material for dental application.

PMID:34313373 | DOI:10.1002/jemt.23880

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Deep Brain Stimulation of Caudal Zona Incerta for Parkinson’s Disease: One-Year Follow-Up and Electric Field Simulations

Neuromodulation. 2021 Jul 27. doi: 10.1111/ner.13500. Online ahead of print.

ABSTRACT

OBJECTIVE: To evaluate the effects of bilateral caudal zona incerta (cZi) deep brain stimulation (DBS) for Parkinson’s disease (PD) one year after surgery and to create anatomical improvement maps based on patient-specific simulation of the electric field.

MATERIALS AND METHODS: We report the one-year results of bilateral cZi-DBS in 15 patients with PD. Patients were evaluated on/off medication and stimulation using the Unified Parkinson’s Disease Rating Scale (UPDRS). Main outcomes were changes in motor symptoms (UPDRS-III) and quality of life according to Parkinson’s Disease Questionnaire-39 (PDQ-39). Secondary outcomes included efficacy profile according to sub-items of UPDRS-III, and simulation of the electric field distribution around the DBS lead using the finite element method. Simulations from all patients were transformed to one common magnetic resonance imaging template space for creation of improvement maps and anatomical evaluation.

RESULTS: Median UPDRS-III score off medication improved from 40 at baseline to 21 on stimulation at one-year follow-up (48%, p < 0.0005). PDQ-39 summary index did not change but the subdomains activities of daily living (ADL) and stigma improved (25%, p < 0.03 and 75%, p < 0.01), whereas communication worsened (p < 0.03). For UPDRS-III sub-items, stimulation alone reduced median tremor score by 9 points, akinesia by 3, and rigidity by 2 points at one-year follow-up in comparison to baseline (90%, 25%, and 29% respectively, p < 0.01). Visual analysis of the anatomical improvement maps based on simulated electrical fields showed no evident relation with the degree of symptom improvement and neither did statistical analysis show any significant correlation.

CONCLUSIONS: Bilateral cZi-DBS alleviates motor symptoms, especially tremor, and improves ADL and stigma in PD patients one year after surgery. Improvement maps may be a useful tool for visualizing the spread of the electric field. However, there was no clear-cut relation between anatomical location of the electric field and the degree of symptom relief.

PMID:34313376 | DOI:10.1111/ner.13500

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Clinical study of graft-versus-host disease prophylaxis in unrelated hematopoietic stem cell transplantation for pediatric nonmalignant diseases with different doses anti-human T-lymphocyte immunoglobulin

Pediatr Transplant. 2021 Jul 27:e14098. doi: 10.1111/petr.14098. Online ahead of print.

ABSTRACT

BACKGROUND: Anti-human T-lymphocyte immunoglobulin is commonly used as prophylaxis for graft-versus-host disease after allogeneic hematopoietic stem cell transplantation from unrelated donors. The studies according to optimum dose of ATLG especially in pediatric patients are limited.

PATIENTS AND METHODS: Outcomes of 99 pediatric patients diagnosed with nonmalignant diseases, who received ATLG as GVHD prophylaxis for matched unrelated donor HSCT at a dose of 10 mg/kg (group 1), 20 mg/kg (group 2), and 30 mg/kg (group 3), were analyzed retrospectively.

RESULTS: The incidences of acute and chronic GVHD were statistically not different between three groups (p = .20 and p = .13), but we did not observe chronic GVHD in group 3 patients. Cox regression analysis showed that ATLG dose of 10 mg/kg (p = .007) and severe acute GVHD (p = .001) were significant prognostic factors for inferior overall survival. Although ATLG dose of 10 mg/kg is effective in pediatric patients on acute and chronic GVHD prevention, TRM and overall survival were superior in ATLG doses ≥20 mg/kg (p = .04 and p = .037) with no difference between 20 and 30 mg/kg.

CONCLUSION: Although ATLG dose of 10 mg/kg is effective in pediatric patients on acute and chronic GVHD prevention and safe from the point of infection, TRM and OS were superior in ATLG doses ≥20 mg/kg with no difference between 20 and 30 mg/kg. These observations should be supported with other multicenter prospective studies including larger patient population.

PMID:34313359 | DOI:10.1111/petr.14098

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The effect of a lifestyle training package on physical activity and nutritional status in obese and overweight pregnant women: A randomized controlled clinical trial

Int J Nurs Pract. 2021 Jul 27:e12992. doi: 10.1111/ijn.12992. Online ahead of print.

ABSTRACT

AIM: The aim of this study was to determine the effect of a lifestyle training package that consisted of a 60- to 90-min session of group training, educational booklet and text messages on physical activity and nutritional status in obese and overweight pregnant women.

METHODS: In this randomized controlled trial, 140 obese or overweight women (gestational age: 16-20 weeks) covered by health centres in Tehran, Iran, were equally randomized into two parallel groups using block randomization and stratified by the body mass index. Participants completed the Food Frequency Questionnaire and International Physical Activity Questionnaire at baseline and fourth and eighth weeks after intervention. Participants were 38 obese and 102 overweight women who were later followed-up.

RESULTS: After the intervention, the mean weekly intake of the vegetable and fruit subgroups was significantly higher; and intake of fats and oils and the confections subgroups were significantly lower in the intervention compared with the control group (p < 0.05). Although physical activity was higher in the intervention group, 8 weeks after the intervention, this difference was not statistically significant (p > 0.05).

CONCLUSIONS: The training package appears to offer a suitable strategy for adjusting the intake of the recommended food subgroups in obese and overweight pregnant women.

PMID:34313366 | DOI:10.1111/ijn.12992

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Whole genome sequencing identifies rare germline variants enriched in cancer related genes in first-degree relatives of familial pancreatic cancer patients

Clin Genet. 2021 Jul 27. doi: 10.1111/cge.14038. Online ahead of print.

ABSTRACT

First-degree relatives (FDRs) of familial pancreatic cancer (FPC) patients have increased risk of developing pancreatic ductal adenocarcinoma (PDAC). Investigating and understanding the genetic basis for PDAC susceptibility in FPC predisposed families may contribute towards future risk-assessment and management of high-risk individuals. Using a Danish cohort of 27 FPC families, we performed whole-genome sequencing of 61 FDRs of FPC patients focusing on rare genetic variants that may contribute to familial aggregation of PDAC. Statistical analysis was performed using the gnomAD database as external controls. Through analysis of heterozygous premature truncating variants (PTV), we identified cancer-related genes and cancer-driver genes harboring multiple germline mutations. Association analysis detected 20 significant genes with false discovery rate, q<0.05 including: PALD1, LRP1B, COL4A2, CYLC2, ZFYVE9, BRD3, AHDC1, etc. Functional annotation showed that the significant genes were enriched by gene clusters encoding for extracellular matrix and associated proteins. PTV genes were over-represented by functions related to transport of small molecules, innate immune system, ion channel transport, and stimuli-sensing channels. In conclusion, FDRs of FPC patients carry rare germline variants related to cancer pathogenesis that may contribute to increased susceptibility to PDAC. The identified variants may potentially be useful for risk prediction of high-risk individuals in predisposed families.

PMID:34313325 | DOI:10.1111/cge.14038