Manufacturer's Guidance Research Articles

Biological attributes required for epidermal regeneration: Evaluation of the next-generation autologous cell harvesting device.

Early wound intervention and closure is critical for reducing infection and improving aesthetic and functional outcomes for patients with acute burn wounds and nonthermal full-thickness skin defects. Treatment of partial-thickness burns or full-thickness injuries with autologous skin cell suspension (ASCS) achieves robust wound closure while limiting the amount of donor skin compared with standard autografting. A Next Generation Autologous Cell Harvesting Device (NG-ACHD) was developed to standardize the preparation process for ASCS to ensure biological attributes are obtained known to correlate with well-established safety and performance data. This study compared ASCS prepared using the NG-ACHD and ACHD following the manufacturer's guidance, evaluating cellular yields, viability, apoptotic activity, aggregates, phenotypes and functional capacity. Non-inferiority was established for all biological attributes tested and comparable healing trajectories were demonstrated using an in vitro skin regeneration model. In addition to standardization, the NG-ACHD also provides workflow efficiencies with the potential to decrease training requirements and increase the ease of incorporation and utilization of ASCS in clinical practice.

Real-world evaluation of Brainomix e-Stroke software.

Brainomix e-Stroke is an artificial intelligence-based decision support tool that aids the interpretation of CT imaging in the context of acute stroke. While e-Stroke has the potential to improve the speed and accuracy of diagnosis, real-world validation is essential. The aim of this study was to prospectively evaluate the performance of Brainomix e-Stroke in an unselected cohort of patients with suspected acute ischaemic stroke. The study cohort included all patients admitted to the University College London Hospital Hyperacute Stroke Unit between October 2021 and April 2022. For e-ASPECTS and e-CTA, the ground truth was determined by a neuroradiologist with access to all clinical and imaging data. For e-CTP, the values of the core infarct and ischaemic penumbra were compared with those derived from syngo.via, an alternate software used at our institution. 1163 studies were performed in 551 patients admitted during the study period. Of these, 1130 (97.2%) were successfully processed by e-Stroke in an average of 4 min. For identifying acute middle cerebral artery territory ischaemia, e-ASPECTS had an accuracy of 77.0% and was more specific (83.5%) than sensitive (58.6%). The accuracy for identifying hyperdense thrombus was lower (69.1%), which was mainly due to many false positives (positive predictive value of 22.9%). Identification of acute haemorrhage was highly accurate (97.8%) with a sensitivity of 100% and a specificity of 97.6%; false positives were typically caused by areas of calcification. The accuracy of e-CTA for large vessel occlusions was 91.5%. The core infarct and ischaemic penumbra volumes provided by e-CTP strongly correlated with those provided by syngo.via (ρ=0.804-0.979). Brainomix e-Stroke software provides rapid and reliable analysis of CT imaging in the acute stroke setting although, in line with the manufacturer's guidance, it should be used as an adjunct to expert interpretation rather than a standalone decision-making tool.

Opposing Flanks vs Parallel Flanks – the Influence of Headless Screw Design on Compression and Pull- Out Resistance

Category: Basic Sciences/Biologics; Basic Sciences/Biologics Introduction/Purpose: Screws generate and maintain compression against distracting forces when performing osteotomy or fusion surgery. Headless screws with opposing flank angles (OFA) between the threads of the head and shaft are purported to achieve better compression. The purpose of this study was to compare OFA designs against traditional parallel flank angle (PFA) headless screws and headed screws to determine differences in compression and pull-out resistance (POR). Methods: In this biomechanical in-vitro study, four screw designs were compared: headless screws with OFA (Screw_A and Screw_B), headless screws with PFA (Screw_C), and headed screws (Screw_D). All screws were 4.0x50mm partially threaded cannulated screws. Screw_B had a 1.4mm shorter head length and 0.5mm narrower head thread diameter than Screw_A and Screw_C, which were similar. A custom apparatus was designed for measuring compression and POR. Osteotomies were created on synthetic bone blocks (density 0.32g/cm3) simulating cancellous bone. Screws were inserted perpendicular to osteotomies in accordance with manufacturer guidance and maximum compression recorded. Increasing distracting forces were then applied to the blocks until the screws pulled out. For each screw type, five screws were tested. Results: There was no significant difference in maximum compression between screw designs: Screw_A=38.7N±14.2N, Screw_B=48.7N±15.6N, Screw_C=51.9N±36.4N, Screw_D=32.0N±9.2N; p=0.921. When assessing POR, all screws failed at the head-bone interface (screw heads subsided into block). Pull-out forces significantly differed between all groups: Screw_A=466N±29.0N, Screw_B=310N±22.0N, Screw_C=399N±46.0N, Screw_D=183N±12.9N; p< 0.001 (ANOVA). Screw_Ahad the highest POR but the other OFA design (Screw_B) had significantly lower POR. Conclusion: Screw design, whether headless (OFA or PFA) or headed did not appear to influence compression generated. However, headed screws had significantly lower POR than headless designs. Within headless designs, OFA may increase POR, but other screw head features (number / diameter of threads) had an apparently greater influence than flank angle.

Accuracy of artificial intelligence software for CT angiography in stroke.

Software developed using artificial intelligence may automatically identify arterial occlusion and provide collateral vessel scoring on CT angiography (CTA) performed acutely for ischemic stroke. We aimed to assess the diagnostic accuracy of e-CTA by Brainomix™ Ltd by large-scale independent testing using expert reading as the reference standard. We identified a large clinically representative sample of baseline CTA from 6 studies that recruited patients with acute stroke symptoms involving any arterial territory. We compared e-CTA results with masked expert interpretation of the same scans for the presence and location of laterality-matched arterial occlusion and/or abnormal collateral score combined into a single measure of arterial abnormality. We tested the diagnostic accuracy of e-CTA for identifying any arterial abnormality (and in a sensitivity analysis compliant with the manufacturer's guidance that software only be used to assess the anterior circulation). We include CTA from 668 patients (50% female; median: age 71 years, NIHSS 9, 2.3 h from stroke onset). Experts identified arterial occlusion in 365 patients (55%); most (343, 94%) involved the anterior circulation. Software successfully processed 545/668 (82%) CTAs. The sensitivity, specificity and diagnostic accuracy of e-CTA for detecting arterial abnormality were each 72% (95% CI = 66-77%). Diagnostic accuracy was non-significantly improved in a sensitivity analysis excluding occlusions from outside the anterior circulation (76%, 95% CI = 72-80%). Compared to experts, the diagnostic accuracy of e-CTA for identifying acute arterial abnormality was 72-76%. Users of e-CTA should be competent in CTA interpretation to ensure all potential thrombectomy candidates are identified.

A retrospective evaluation of direct oral anticoagulant (DOAC) management strategies in patients with cancer on active chemotherapy.

Use of direct oral anticoagulants (DOACs) in patients with cancer on active chemotherapy is challenging due to changes in renal or hepatic function, thrombocytopenia, chemotherapy-induced nausea and vomiting (CINV), and drug-drug interactions (DDIs) attributed to disease or treatment. The purpose of this retrospective cohort analysis was to characterize DOAC management through various interventions and evaluate the efficacy and safety of DOAC use in this patient population. A total of 58 patients with 97 unique index periods in which a patient was concomitantly on a DOAC and chemotherapy were identified. Several instances were observed in which an intervention should be made based on manufacturer guidance or clinical judgment. Of 37 instances attributed to changes in renal function, the following interventions were employed: dose adjustments (10/37), holding DOAC therapy until renal function improved (held 3/37, restarted 4/37), changing to an alternative anticoagulant (5/37), DOAC discontinuation (2/37), or no change (13/37). One change was made in response to decreased hepatic function (1/15). DOACs were held in the setting of platelet counts below 50K/mm3 (8/20) and restarted when platelets improved above this threshold (5/20). In patients with CINV, DOAC therapy was continued (26/32) with few changes made. To manage DOAC-chemotherapy DDIs, changes in DOAC agents (4/6) and dose reductions in chemotherapy agents (2/6) were made. Thrombotic and bleeding events did not strongly correlate with renal or hepatic impairment, thrombocytopenia, CINV, or DDIs. Further guidance regarding the use of these agents in this patient population is warranted to address management strategies, efficacy, and safety. Use of direct oral anticoagulants (DOACs) in patients with cancer on active chemotherapy is challenging due to changes in renal or hepatic function, thrombocytopenia, chemotherapy-induced nausea and vomiting (CINV), and drug-drug interactions (DDIs) attributed to disease or treatment. The purpose of this retrospective cohort analysis was to characterize DOAC management and evaluate the efficacy and safety of DOAC use in this patient population. A total of 58 patients with 97 unique index periods in which a patient was concomitantly on a DOAC and chemotherapy were identified. Several instances were observed in which an intervention should be made based on manufacturer guidance or clinical judgment. Interventions employed are summarized graphically. Thrombotic and bleeding events did not strongly correlate with renal or hepatic impairment, thrombocytopenia, CINV, or DDIs. CINV chemotherapy-induced nausea and vomiting, DDIs drug-drug interactions, DOAC direct oral anticoagulant, OAC oral anticoagulant.

A Single-Center Study of Long-Term Effectiveness of Vedolizumab in Anti-TNF Refractory Pediatric Inflammatory Bowel Disease.

A real-life, single-center, retrospective study of PIBD patients treated with vedolizumab was performed. Data on demographics, prior and concomitant treatments, and disease activity were obtained at 14 weeks, 26 weeks, 1 year, and 2 years of therapy. Primary outcome was corticosteroid- and other biologic-free remission (based on pediatric ulcerative colitis activity index [PUCAI]). Thirty-nine patients were studied. By 1 year, 65% of CD and 68% of UC patients continued on vedolizumab therapy. Corticosteroid- and other biologic-free remission was 29% in CD and 16% in UC. By 2 years, 36% of CD and 47% of UC patients continued therapy. Corticosteroid- and other biologic-free remission was 21% in CD and 40% in UC. By 2 years, 80% of CD and 100% of UC patients were on intensified treatment regimen compared to the manufacturer guidance. Nine patients (23%) required surgical intervention within 26 months of starting vedolizumab indicating the severity of IBD in this cohort. Vedolizumab is a useful therapeutic modality in PIBD patients refractory to anti-TNF therapy, although with declining effectiveness by 2 years. Intensified treatment regimens are associated with long-term durability. Larger prospective trials in children are warranted.

AIUM Official Statement: Guidelines for Cleaning and Preparing External- and Internal-Use Ultrasound Transducers and Equipment Between Patients as Well as Safe Handling and Use of Ultrasound Coupling Gel.

AIUM Official Statement: Guidelines for Cleaning and Preparing External- and Internal-Use Ultrasound Transducers and Equipment Between Patients as Well as Safe Handling and Use of Ultrasound Coupling Gel.

Evaluation of the Safety and Efficacy of Hand Sanitizer Products Marketed to Children Available during the COVID-19 Pandemic.

Hand sanitizer use in the United States (U.S.) increased after the SARS-CoV-2 outbreak. The U.S. Food and Drug Administration (FDA) released temporary manufacturer guidance, changing impurity level limits for alcohol-based hand sanitizers (ABHSs). Since the guidance took effect, the FDA has recommended against using these hand sanitizers due to concerns over safety, efficacy, and/or risk of incidental ingestion. To address current gaps in exposure characterization, this study describes a survey of ABHSs marketed to children available in the U.S., as defined by several inclusion criteria. A subset of ABHSs (n = 31) were evaluated for ethanol and organic impurities using a modified FDA method. Products with detectable impurity levels were compared to the FDA's established interim limits. Seven children's products had impurity levels exceeding the FDA's recommended interim limits, including benzene (up to 9.14 ppm), acetaldehyde (up to 134.12 ppm), and acetal (up to 75.60 ppm). The total measured alcohol content ranged from 52% to 98% in all hand sanitizers tested, ranging from 39% below, and up to 31% above, the labeled concentration. Future studies should confirm impurity contamination sources. A risk assessment could determine whether dermal application or incidental ingestion of impurity-containing hand sanitizers pose any consumer risk.

Influence of Heat Treatment of Nickel-Titanium Instruments on Cyclic Fatigue Resistance in Simulated Curved Canals.

The aim of this study was to compare the cyclic fatigue of heat-treated and non-treated instruments. Twenty instruments with and without heat treatment from Bassi Logic were evaluated (n = 10). All instruments were subjected to dynamic cyclic fatigue through continuous rotations inside a stainless-steel tube (1.4-mm diameter, 9-mm curvature with 6-mm radius, and 90° angle) using a custom-made device, which performed 1 axial oscillation every 2 seconds with an amplitude of 3 mm, powered by a torque-controlled motor (Silver Reciproc, VDW, Germany), with speed adjusting to 950 rpm and torque to 4 N, according to manufacturer's guidance. The groups were compared using the Mann-Whitney test. The fracture time of the heat-treated instruments (97.20 ± 39.94 second and non-treated instruments (14.30 ± 6.78 seconds had statistical differences [p < 0.05]). Heat-treated instruments were 6.8 times more resistant to fatigue than non-treated instruments (p < 0.05). Heat treatment provides increased fatigue resistance of NiTi alloy with the same design.

Outcomes of Children and Young Adults with Acute Lymphoblastic Leukaemia Administered Inotuzumab Pre CAR-T Therapy

Introduction:Immunotherapies like Inotuzumab ozogamicin (InO), Blinatumomab and Chimeric antigen receptor T cell therapy (CAR-T) have revolutionized outcomes in patients with Relapse/Refractory Acute Lymphoblastic Leukaemia (R/R ALL) with event free survival (EFS) of 50% at 1 year (Maude et al. 2018).Optimal phasing of these agents has not been clearly defined and depends on antigen expression on blasts, CNS status, T cell number and prior disease response. InO, a CD22 targeting antibody-drug conjugate has proven efficacy in adults (Kantarjian et al., 2016) and children as a bridge to allogeneic stem cell transplantation (allo-SCT) with a favourable toxicity profile (Brivio et al. 2021). However, outcomes following the use of InO prior to CAR-T therapy are still not established.This study provides a retrospective analysis of children and young adults who received InO as part of pre-CAR-T management (before leucapheresis or as bridging therapy to CAR-T infusion).Methods:Patients aged 0-25years with R/R ALL were eligible for the study if they received InO pre-CAR-T therapy. Retrospective data collection was performed using a standardised form from CAR-T centres in the UK. Response to CAR-T therapy and/or relapse was evaluated at 1, 3, 6, 12 months or at last follow-up. Results were compared to a control cohort of R/R ALL patients treated with tisagenlecleucel but without preceding InO, over a contemporaneous period, at the largest paediatric CAR-T centre in the UK.Results:Fourteen patients from 5 paediatric and young adult centres in the UK received InO after screening for CAR-T therapy. InO was used pre-leucapheresis, as bridging and for both in 2, 11 and 1 respectively. Two were excluded from outcome analysis (1 adolescent with Trisomy 21 and transfusion induced hepatic siderosis died due to VOD while awaiting CAR-T production and 1 failed CAR-T manufacture despite achieving an adequate T cell harvest as per manufacturer guidance). Twelve (85%) patients were able to receive CAR-T infusion at a median of 1 month (range 0.7-5.6 months) from first InO dose. InO was well tolerated with 21% developing febrile neutropenia and grade 4 cytopenias. Use of InO pre-leucapheresis led to successful manufacture of CAR-T cells in 2/3 (66%). InO group was compared with 27 children who received CAR-T without preceding InO over the same time period. Table 1 summarises patient and CAR-T characteristics of the two groups which were comparable. Median follow-up of the InO and non-InO groups was 10 months (range 2.8- 30.1 months).In the InO group(n=12), 3 (25%) remained leukemia free at last follow up. Nine patients (75%) relapsed. All relapses occurred within 6 months from CAR-T infusion. Seven (58%) of those who relapsed died at a median of 7.8 months post CAR-T infusion and 2 (16.6%) were salvaged with further therapy. Subsequent therapy (alternate CAR-T and/or allo-SCT) was carried out in 4/12 (33%) patients in the InO group and in 5/27 (18.5%) in the non-InO group (p= 0.2). EFS was significantly higher in the non-InO group (53% vs 12%, p=0.0009), as was OS (86% vs 13%, p=0.004) (Figure 1).Conclusion:This study provides a direct comparison between two contemporaneously treated cohorts with R/R ALL receiving CAR-T therapy. InO prior to CAR T cell therapy was well tolerated despite the cohort being heavily pre-treated except for one patient who developed fatal VOD prior to CAR T cell infusion. InO was given for disease debulking, rather than to achieve MRD negativity and hence majority of the cohort (75%) received only 1 dose of InO in bridging rather than the usual schedule of three doses weekly per cycle.Outcomes for the non-InO group were comparable to those treated on the ELIANA study but the OS of the InO group was significantly lower (13% vs 86% p= 0.004). Potential reasons include an impact of InO on function of CAR-T cells in vivo or a deleterious effect of InO on the B cell compartment such that CAR-T cells prove less effective. Due to the retrospective nature of the study, it is possible there was an inherent bias to use InO in patients with more resistant disease, although the very comparable pre CAR-T bone marrow disease burden in each group suggests this was not the case. The small size of the cohorts may also have exaggerated differences in outcome.Ultimately, randomised controlled studies of InO pre-CAR-T are required before firm conclusions about its impact on outcomes post CAR-T therapy can be ascertained. [Display omitted] DisclosuresSharplin: Kite Gilead: Honoraria; Novartis: Other: Travel Support. Nicholson: BMS/Celgene: Consultancy; Kite, a Gilead Company: Other: Conference fees, Speakers Bureau; Novartis: Consultancy, Other: Conference fees; Pfizer: Consultancy. Amrolia: ADC Therapeutics: Other: Named inventor on a patent which is being transferred to ADCT.; Autolus: Patents & Royalties. Ghorashian: Novartis: Honoraria; UCLB: Patents & Royalties.

Determination of a cone-beam CT low-dose protocol for root fracture diagnosis in non-endodontically treated anterior maxillary teeth.

The aim of this study was to determine a "low-dose protocol" which provides acceptable diagnostic accuracy for detection of root fractures in unrestored anterior maxillary teeth, using an ex vivo model. 48 maxillary anterior teeth, half with horizontal or oblique root fractures, were imaged using CBCT in an anthropomorphic model. Nine X-ray exposure combinations were used, including the manufacturer's standard ("reference") exposure and high-resolution settings ("HiRes"), by varying kV, exposure time, and rotation angle. Measurements of Dose Area Product (DAP) were recorded. Five dental radiologists assessed the scans for root fractures and judged image quality. Parameters of diagnostic accuracy were calculated, including area under the Receiver Operating Characteristic curve (Az). Objective measures of image quality were made at the same exposure combinations using an image quality phantom. Although there was a significant linear relationship between DAP and mean Az, only the lowest DAP exposure combination had a mean Az significantly different to the reference exposure. There was no significant effect on other diagnostic accuracy parameters when using HiRes compared with the reference exposure. There was a significant positive relationship between DAP and contrast resolution. HiRes did not significantly improve contrast resolution and made a small improvement to spatial resolution. Scope existed for radiation dose reduction compared with the manufacturer's guidance. There was no improvement in diagnostic accuracy using HiRes settings. A cautious recommendation for this CBCT machine is that it is possible to achieve a dose reduction of about 20% compared with the reference exposure parameters.

Extended detail contrasts for TO.10 use on flat panel detector fluoroscopy systems

Leeds Test Object Ten (TO.10) is routinely used to subjectively estimate Threshold Contrast Detail Detectability (TCDD) as a measure of image quality in fluoroscopy. However, manufacturer guidance provides calibrated contrasts for only limited peak voltage and copper filtration thickness combinations. Prescribed testing conditions are often difficult to attain as modern flat panel fluoroscopic systems independently determine voltage and copper filtration thickness settings. This work aims to extend the range of TO.10 contrasts available for routine testing at peak voltage and copper thickness settings likely to be encountered. Two methods are described for generalising the calculation of target contrasts: a three-dimensional interpolation/extrapolation model in MATLAB®, and a multivariate log-polynomial function. Both methods utilise the available calibrated contrasts to estimate contrasts at voltage and copper thickness combinations routinely encountered. Results are presented as Threshold Detection Index [Formula: see text] curves fit by a second-order polynomial of log [Formula: see text] to log [Formula: see text] . Results are found to be more accurate at unprescribed conditions while also reproducible for relatively consistent input air kerma rate (IAKR) expected from automatic dose rate controls (ADRC). The calculation of TO.10 contrasts at non-standard conditions aids in the determination of an absolute estimate of image quality in fluoroscopy with greater accuracy, reproducibility and efficiency. TO.10 detail contrasts for TCDD testing of fluoroscopy units have been significantly extended beyond those previously available. The described methods will aid the clinical physicist in absolute assessments of fluoroscopic image quality and facilitate inter system comparisons.

State-of-the-Practice Review on the Use of Flocculants for Construction Stormwater Management in the United States

Construction stormwater practices have a vital role in protecting downstream water bodies from runoff that is typically characterized with large amounts of sediment and suspended solids. Most sediment control practices lack the capability to capture fine-sized soil particles that are responsible for causing elevated turbidity. Flocculation is a form of chemical treatment that uses flocculant particles as a binding bridge to form larger particles to enhance the gravitational settling process. The use of flocculants provides promising results for removing fine particles and treating construction stormwater. This study provides a comprehensive review of flocculants and their applications in construction stormwater treatment in the U.S. The study presents a literature review and results of a state-of-the-practice survey distributed to state departments of transportation. Results from 37 participating state agencies and data from specifications and design manuals for non-participating agencies were compiled to develop a comprehensive understanding of current uses and perceptions. Results indicated that 39% of state agencies currently use flocculants on construction sites. Within that, 54% of the state agencies rely on manufacturer guidance for dosage and application rates and only 23% require monitoring residual flocculant in downstream receiving waters. The potential risk of polluting downstream water bodies because of overdosage of flocculants related to inadequate application rates and techniques is the main concern of the state departments of transportation on flocculant usage. Understanding the perspective of the state agencies on flocculants will provide an insight into future research agendas for extending the use of flocculants in construction stormwater management.

The AAHKS Best Podium Presentation Research Award: Comparing the Efficacy of Irrigation Solutions on Staphylococcal Biofilm Formed on Arthroplasty Surfaces

BackgroundA diverse array of antibacterial solutions is utilized by orthopedic surgeons in an attempt to disperse bacterial biofilm. Few studies compare these agents against biofilm grown on clinically relevant orthopedic biomaterials, such as plastic, acrylic cement, and porous titanium. MethodsMSSA biofilm was grown on plastic 48-well plates, polymethylmethacrylate cement beads and porous Ti-6Al-4V acetabular screw caps. Antibacterial solutions were tested according to manufacturer guidance and included: isotonic saline, vancomycin (1 mg/mL), polymyxin-bacitracin (500,000 U/L-50,000 U/L), povidone-iodine 0.3%, povidone-iodine 10%, a 1:1 combination of povidone-iodine 10% & 4% hydrogen peroxide, polyhexamethylene biguanide (PHMB) and betaine 0.04%, a commercial solution containing chlorhexidine gluconate (CHG) 0.05%, and a commercial solution containing benzalkonium chloride and ethanol. Twenty four and 72-hour biofilms were exposed to solutions for 3 minutes to reproduce intraoperative conditions. Solution efficacy was measured through sonication of treated surfaces followed by counting colony forming units and validated with a resazurin assay to assess cell viability. Experiments were performed in triplicate and repeated at least once. A three-fold log reduction in CFU counts versus controls was considered as a measure of solution efficacy. ResultsSaline, vancomycin and polymyxin-bacitracin were ineffective compared to other solutions against planktonic MSSA. Povidone-iodine 10% and a 1:1 solution of povidone-iodine 10% and 4% hydrogen peroxide were the only effective solutions against biofilm across all three surfaces and time points. ConclusionCommercial antibacterial solutions vary significantly in their efficacy against MSSA biofilm. Efficacy globally decreased as biofilm maturity increased. Increased solution cost did not confer increased efficacy.

Long noncoding RNA SOX2OT maintains the stemness of pancreatic cancer cells by regulating DEK via interacting with miR-200a/141.

The article "Long noncoding RNA SOX2OT maintains the stemness of pancreatic cancer cells by regulating DEK via interacting with miR-200a/141, by C.-S. Liu, Q. Zhou, Y.-D. Zhang, Y. Fu, published in Eur Rev Med Pharmacol Sci 2020; 24 (5): 2368-2379-DOI: 10.26355/eurrev_202003_20504-PMID: 32196588" has been withdrawn from the authors stating that "to validate the effect of lncRNA-SOX2OT, we constructed SOX2OT overexpressed cells using lentiviral vector with -IRES2-EGFP to easily visualize the transfection efficiency. Therefore, the stably transfected cells were carrying the green fluorescence. However, during our Flow cytometry assay, we took PC cells (Control) with no fluorescence to standardize our equipment and measured the negative control (NC) and overexpressed-Sox2ot (oe-Sox2ot) according to the manufacturer's guidance, without removing the disturbance that the green fluorescence caused. This means that, despite having performed the standard assay, the results obtained in Figure 2D were wrong and unscientific". The Publisher apologizes for any inconvenience this may cause. https://www.europeanreview.org/article/20504.

Cortrak feeding tube placement: accuracy of the 'GI flexure system' versus manufacturer guidance.

Determine the accuracy of manufacturer guidance in trace interpretation against what is referred to as the 'GI flexure system'. The authors prospectively observed the accuracy of the 'GI flexure system' of trace interpretation against manufacturer guidance in primary nasointestinal (NI) tube placements. Contrary to manufacturer guidance, 33% of traces deviated >5 cm from the sagittal midline and 26.5% were oesophageal when entering the lower left quadrant, incorrectly indicating lung and gastric placement, respectively. Conversely, the GI flexure system identified ≥99.4% of GI traces when they reached the gastric body flexure; 100% at the superior duodenal flexure. All lung misplacements were identified by the absence of GI flexures. Current manufacturer guidance should be updated to the GI flexure system of interpretation.

Donor-Derived Cell Free DNA: Is It All the Same?

Clinical utility of donor-derived, cellfree DNA (dd-cfDNA) in transplantation has been extensively reviewed, supporting its use as a surveillance tool for the early and accurate detection of allograft injury. Yet studies comparing different assay methods have been lacking. Paired sampling of commercially available dd-cfDNA (AlloSure and Prospera) was compared and examined against histology and manufacturer guidance. A total of 76 patients were prospectively assessed, with 11 biopsy sample-proven rejections (antibody-mediated rejection, n=2; T cell-mediated rejection, n=9). Prospera demonstrated larger measurements of dd-cfDNA in comparison with AlloSure, but this was NS (P=0.12). At current manufacturer recommended diagnostic cutoffs, there was no significant difference in sensitivity, specificity, negative predictive value, or positive predictive value of AlloSure versus Prospera in detecting rejection. AlloSure demonstrated a significantly shorter turnaround time (P=0.01) from blood draw to patient result. Although dd-cfDNAs are similar, they are not the same. Extensive evidence for dd-cfDNA interpretation remains the key to building clinical utility when considering clinical implementation, and remaining consistent to a single platform is important when creating data comparisons.

Big Data Mining Analysis of Key Indicators of Online New Energy Vehicles

In this paper, more than 300 new energy vehicle key indicators of online sales are mined, and big data visualization analysis is carried out. In October 2018, big data mining analysis was conducted on the brand, model, pure electric endurance, slow charging time, fast charging time, battery capacity, maximum power, maximum torque, monthly sales volume, annual cumulative sales volume, monthly transaction price, user score, number of public praise, manufacturer guidance price (low) and manufacturer guidance price (high) of each new energy vehicle market in Sina auto.com. The results show that the average pure electric endurance of new energy vehicles is 210.3 km (with a maximum endurance of 613 km), and the average fast charging time is 1.7 hours (with a minimum duration of half an hour). The best-known brand of new energy vehicles is BYD, with the highest market share of BYD and Toyota.

Undetected Cortrak tube misplacements in the United Kingdom 2010–17: An audit of trace interpretation

ObjectivesDetermine why Cortrak-guided, undetected tube misplacement may occur in relation to the system of trace interpretation used. MethodologyFrom 2010 to 2017 we obtained seven of the eight Cortrak traces from the United Kingdom where misplacement was undetected and the patient received feed. Seven suffered serious harm. Each misplacement was interpreted by three systems: screen position, manufacturer guidance and gastrointestinal (GI) flexures. SettingNational and local records. Main outcome measuresAbility to identify misplacement. ResultsTraces that were later identified as misplacements, could not be differentiated from GI position when they wholly or partially: a) overlapped with the GI screen area plotted from historical records (57–71%) or b) met both manufacturer guidance criteria or were confused with receiver misplacement or unusual anatomy and reached the lower left quadrant (14–71%). Conversely, all lung misplacements were identified as unsafe using the GI flexure system. All three systems failed to detect the intra-peritoneal trace. Traces were inconsistently stored by healthcare centres. ConclusionTrace file storage should be mandated by and accessible to relevant health authorisation bodies to improve safety research. Screen position alone and manufacturer guidance fail to consistently differentiate the shape of safe from unsafe traces. GI flexure interpretation appears safer but requires testing in larger studies.

Risk of excavators overturning

PurposeTracked hydraulic excavators are versatile and ubiquitous items of off-highway plant and machinery that are utilised throughout the construction industry. Each year, a significant number of excavators overturn whilst conducting a lifting operation, causing damage to property, personnel injury or even fatality. The reasons for the overturn are myriad, including: operational or environmental conditions; machine operator acts or omissions; and/or inadequate site supervision. Furthermore, the safe working load (SWL) figure obtained from manufacturer guidance and utilised in lift plans is based upon undertaking a static load only. The purpose of this paper is to determine whether the SWL is still safe to be used in a lift plan when slewing a freely suspended (dynamic) load, and, if not, whether this may be a further contributory factor to overturn incidents.Design/methodology/approachPrevious research has developed a number of machine stability test regimes but these were largely subjective, impractical to replicate and failed to accurately measure the “dynamic” horizontal centrifugal force resulting from slewing the load. This research contributes towards resolving the stability problem by critically evaluating existing governing standards and legislation, investigating case studies of excavator overturn and simulating the dynamic effects of an excavator when slewing a freely suspended load at high rotations per minute (rpm). To achieve this, both the static load and horizontal centrifugal force from slewing this load were calculated for six randomly selected cases of an excavator, with different arm geometry configurations.FindingsThe results from the six cases are presented and a worked example of one is detailed to demonstrate how the results were derived. The findings reveal that the SWL quoted on an excavator’s lift rating chart considerably underestimates the extra forces experienced by the machine when an additional dynamic load is added to the static load whilst lifting and slewing a freely suspended load.Originality/valueThis work presents the first attempt to accurately model excavator stability by taking consideration of the dynamic forces caused by slewing a freely suspended load and will lead to changes in the way that industry develops and manages lift plans. Future research proposes to vary the weight of load, arm geometry and rpm to predict machine stability characteristics under various operational conditions, and exploit these modelling data to populate pre-programmed sensor-based technology to monitor stability in real time and automatically restrict lift mode operations.