Publications by authors named "E M Jensen"

1,483 Publications

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Investigating diversity in European audiences for public engagement with research: Who attends European Researchers' Night in Ireland, the UK and Malta?

PLoS One 2021 14;16(7):e0252854. Epub 2021 Jul 14.

Trinity College Dublin, Dublin, Ireland.

European Researchers' Night is an annual pan-European synchronized event devoted to public engagement with research. It was first held in 2005 and now occurs in over 400 cities across Europe, with the aim of bringing researchers closer to the general public. To investigate social inclusion in these events, we conducted survey research across three national contexts (Ireland, Malta and the UK) and events in seven cities between 2016 and 2019 (n = 1590). The results from this exploratory descriptive study confirmed one hypothesis, namely that event attendees had substantially higher levels of university qualification than the national publics. This is in line with wider patterns of unequal participation in public engagement with research activities based on socio-economic status. However, we also found mixed evidence on the prevalence of ethnic minority representation among event attendees compared to the general population, thus failing to uphold the second hypothesis that predicted an over-representation of white majority participants. This second finding diverges from existing research findings about ethnic diversity amongst science communication audiences, raising the possibility that some public engagement events are over-performing on this dimension of social inclusion. Overall, the findings demonstrate that European Researchers' Night has potential for addressing the critical goal of enhancing the diversity of audiences for public engagement with research, even as it falls short on the key metric of socio-economic diversity.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0252854PLOS
July 2021

Characterization and Management of Treatment-emergent Hepatic Toxicity in Patients with Advanced Renal Cell Carcinoma Receiving First-line Pembrolizumab plus Axitinib. Results from the KEYNOTE-426 Trial.

Eur Urol Oncol 2021 Jul 6. Epub 2021 Jul 6.

Barts Health and the Royal Free NHS Trusts, Barts Cancer Institute, and Queen Mary University of London, London, UK.

Background: Pembrolizumab plus axitinib improved efficacy over sunitinib in treatment-naive advanced renal cell carcinoma in the KEYNOTE-426 (NCT02853331) study. However, a relatively high incidence of grade 3/4 aminotransferase elevations was observed.

Objective: To further characterize treatment-emergent aminotransferase elevations in patients treated with pembrolizumab-axitinib.

Design, Setting, And Participants: Patients enrolled in KEYNOTE-426 were included in this study.

Outcome Measurements And Statistical Analysis: Three Standardized MedDRA Queries for potential hepatic disorders were used to identify patients for the hepatic event analysis subpopulation (HEAS). Alanine aminotransferase events were characterized for time to onset, time to recovery, corticosteroid use, and rechallenge with study treatment(s).

Results And Limitations: The HEAS comprised 189/429 (44%) pembrolizumab-axitinib patients and 128/425 (30%) sunitinib patients. Grade 3/4 hepatic adverse events were more common in the combination arm: 22% (94/429) versus 7% (29/425); 3% (13/429) discontinued the combination due to hepatic adverse events. In the pembrolizumab-axitinib arm, 125/426 patients (29%) had alanine aminotransferase (ALT) ≥3× upper limit of normal (ULN), with median time to onset of 84 d (range, 7-840 d). Among patients with ALT ≥3× ULN, 120/125 (96%) recovered to <3× ULN following study treatment interruption/discontinuation, with a median time to recovery of 15 d (3-176 d): 68/120 (57%) received corticosteroids. One hundred patients were rechallenged with one or both study treatment(s): 45/100 (45%) had ALT ≥3× ULN recurrence, and all 45 recovered to ALT <3× ULN following study treatment interruption/discontinuation. No fatal hepatic events occurred.

Conclusions: A higher incidence of grade 3/4 aminotransferase elevations occurs with pembrolizumab-axitinib. These events should be carefully evaluated and managed with prompt study treatment interruption or discontinuation, with or without corticosteroid treatment. The decision to rechallenge with one or both drugs should be based on severity of event and thorough causality assessment.

Patient Summary: Renal cell carcinoma patients receiving pembrolizumab-axitinib are at a higher risk of liver enzyme elevations, which could be reversed with appropriate management.
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http://dx.doi.org/10.1016/j.euo.2021.05.007DOI Listing
July 2021

Development of a Core Outcome Set for Therapeutic Studies in Eosinophilic Esophagitis (COREOS).

J Allergy Clin Immunol 2021 Jul 6. Epub 2021 Jul 6.

Inform Diagnostics, Irving, TX, USA; Department of Pathology, Baylor College of Medicine, Houston, TX, USA.

Background: Endpoints used to determine treatment efficacy in eosinophilic esophagitis (EoE) have evolved over time. With multiple novel therapies in development for EoE, harmonization of outcomes measures will facilitate evidence synthesis and appraisal when comparing different treatments.

Objective: To develop a core outcome set (COS) for controlled and observational studies of pharmacologic and diet interventions in adult and pediatric patients with EoE.

Methods: Candidate outcomes were generated from systematic literature reviews and patient engagement interviews and surveys. Consensus was established using an iterative Delphi process, with items voted on using a 9-point Likert scale and with feedback from other participants to allow score refinement. Consensus meetings were held to ratify the outcome domains of importance and the core outcome measures. Stakeholders were recruited internationally and included adult and pediatric gastroenterologists, allergists, dieticians, pathologists, psychologists, researchers, and methodologists.

Results: The COS consists of four outcome domains for controlled and observational studies: histopathology, endoscopy, patient-reported symptoms, and EoE-specific quality of life (QoL). A total of 69 stakeholders (response rate 95.8%) prioritized 42 outcomes in a two-round Delphi process and the final ratification meeting generated consensus on 33 outcome measures. These included measurement of the peak eosinophil count, EoE Histology Scoring System, EoE Endoscopic Reference Score, and patient-reported measures of dysphagia and QoL.

Conclusions: This interdisciplinary collaboration involving global stakeholders has produced a COS that can be applied to adult and pediatric studies of pharmacologic and diet therapies for EoE, which will facilitate meaningful treatment comparisons and improve the quality of data synthesis.
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http://dx.doi.org/10.1016/j.jaci.2021.07.001DOI Listing
July 2021

Performance Evaluation of Nasal Prong Interface for CPAP Delivery on a Critical Care Ventilator: A Bench Experiment.

Respir Care 2021 Jul 6. Epub 2021 Jul 6.

Division of Anesthesia and Critical Care, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania.

Background: The RAM cannula (Neotech, Valencia, CA) has become a commonly used interface for CPAP in neonatal intensive care. Performance characteristics of this interface used with a critical care ventilator are not well described.

Methods: This was a bench study utilizing a lung simulator configured as an actively breathing infant (weights of 800 g, 1.5 kg, and 3 kg) with moderate lung disease and a critical care ventilator in CPAP mode with leak compensation on. Three sizes of the RAM cannulae (preemie, newborn, and infant) were compared to 3 BabyFlow nasal prongs (Dräger Medical, Lübeck, Germany) (medium, large, and extra-large). Fabricated nasal models produced a 70% occlusive fit for the RAM cannula and an occlusive fit with the Dräger prongs. Delivered flow and pressure levels were recorded at 9 CPAP levels between 5 and 20 cm HO.

Results: The Dräger prongs produced a mean airway pressure (P̅) within 0.20 cm HO (range -0.10 to 0.35) of the set CPAP across all evaluated prong sizes and CPAP levels. In contrast, the RAM cannula produced P̅ values that averaged 8.5 cm HO (range -15 to -3.5) below the set CPAP levels. The deficit in delivered versus target CPAP level for the RAM cannula increased with greater set CPAP. Set CPAP of 5 cm HO delivered P̅ values that ranged from 0.6 to 1.5 cm HO (difference of 3.5-4.4 cm HO). Set CPAP of 20 cm HO delivered P̅ values that ranged from 5.0 to 8.4 cm HO (difference of 11.7-15 cm HO). Inspiratory flow required to achieve set CPAP levels did not differ between interfaces, suggesting high resistance in the RAM cannula device masks the delivered CPAP levels.

Conclusions: Use of the RAM cannula with a 30% leak on a critical care ventilator delivered P̅ values lower than set CPAP. This may be clinically meaningful and should be considered when choosing a nasal interface.
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http://dx.doi.org/10.4187/respcare.09018DOI Listing
July 2021

Evolving Respiratory Care of the Preterm Infant.

JAMA Pediatr 2021 Jul 6. Epub 2021 Jul 6.

Children's Hospital of Philadelphia, Philadelphia, Pennsylvania.

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http://dx.doi.org/10.1001/jamapediatrics.2021.1918DOI Listing
July 2021