Aim: The current study compared preparation time, errors, satisfaction, and preference for a prefilled syringe (PFS) versus two RSV vaccines requiring reconstitution (VRR1 and VRR2) in a randomized, single-blinded time and motion study.
Methods: Pharmacists, nurses, and pharmacy technicians were randomized to a preparation sequence of the three vaccines. Participants read instructions, then consecutively prepared the three vaccines with a 3-5-min washout period in between.
Patients with advanced or recurrent endometrial cancer (EC) have limited treatment options following platinum-based chemotherapy and poor prognosis. The single-arm, Phase I GARNET trial (NCT02715284) previously reported dostarlimab efficacy in mismatch repair-deficient/microsatellite instability-high advanced or recurrent EC. The objective of this study was to compare overall survival (OS) and describe time to treatment discontinuation (TTD) for dostarlimab (GARNET Cohort A1 safety population) with an equivalent real-world external control arm receiving non-anti-programmed death (PD)-1/PD-ligand (L)1/2 treatments (constructed using data from a nationwide electronic health record-derived de-identified database and applied GARNET eligibility criteria).
View Article and Find Full Text PDFObjectives: Immune checkpoint inhibitors have emerged as novel treatment options in patients with endometrial cancer. In this study we aimed to compare the survival outcomes of patients with recurrent or advanced endometrial cancer. These patients had received dostarlimab after platinum-based chemotherapy in the single-arm, Phase I GARNET trial.
View Article and Find Full Text PDFBackground: The European Colonoscopy Quality Investigation (ECQI) Group aims to raise awareness for improvement in colonoscopy standards across Europe. We analysed data collected on a sample of procedures conducted across Europe to evaluate the achievement of the polyp detection rate (PDR) target. We also investigated factors associated with PDR, in the hope of establishing areas that could lead to a quality improvement.
View Article and Find Full Text PDFObjectives: Real-world evidence (RWE) plays an important role in addressing key research questions of interest to healthcare decision makers. Federated data networks (FDNs) apply novel technology to enable the conduct of RWE studies with multiple partners, without the need to share the individual partner's data set. A systematic review of the published literature was performed to determine which types of research questions can best be addressed through FDNs, specifically in the field of oncology.
View Article and Find Full Text PDFUnlabelled: The European Colonoscopy Quality Investigation (ECQI) Group aims to raise awareness for improvement in colonoscopy standards across Europe. We analyzed data collected on a sample of procedures conducted across Europe to evaluate the achievement of the European Society of Gastrointestinal Endoscopy (ESGE) mean withdrawal time (WT) target. We also investigated factors associated with WT, in the hope of establishing areas that could lead to a quality improvement.
View Article and Find Full Text PDFBackground And Study Aims: Proton pump inhibitors (PPI) are one of the most often prescribed drugs worldwide. They were thought to have a great safety profile before adverse effects in case of long-term medication were discussed recently. Undoubtedly, the use of PPI has to be based on a clear indication.
View Article and Find Full Text PDFThe European Colonoscopy Quality Investigation (ECQI) Group comprises expert colonoscopists and investigators with the aim of raising colonoscopy standards. We assessed the levels of monitoring and achievement of European Society of Gastrointestinal Endoscopy (ESGE) performance measures (PMs) across Europe using responses to the ECQI questionnaires. The questionnaire comprises three forms: institution and practitioner questionnaires are completed once; a procedure questionnaire is completed on multiple occasions for individual total colonoscopies.
View Article and Find Full Text PDFAmorphous silica-aluminas (ASAs) are important solid catalysts and supports for many industrially essential and sustainable processes, such as hydrocarbon transformation and biorefining. However, the wide distribution of acid strength on ASAs often results in undesired side reactions, lowering the product selectivity. Here we developed a strategy for the synthesis of a unique class of ASAs with unvarying strength of Brønsted acid sites (BAS) and Lewis acid sites (LAS) using double-flame-spray pyrolysis.
View Article and Find Full Text PDFBackground: Hereditary angioedema (HAE) with C1-esterase inhibitor (C1-INH) deficiency is a rare disease associated with painful, potentially fatal swelling episodes affecting subcutaneous or submucosal tissues. HAE attacks recur with unpredictable severity and frequency throughout patients' lives; long-term prophylaxis is essential for some patients. In the absence of head-to-head studies, indirect treatment comparison (ITC) of long-term prophylactic agents is a valid approach to evaluate comparative efficacy.
View Article and Find Full Text PDFThe diffusion of saturated and unsaturated hydrocarbons is of fundamental importance for many zeolite-catalyzed processes. Transport of small alkenes in the confined zeolite pores can become hindered, resulting in a significant impact on the ultimate product selectivity and separation. Herein, intracrystalline light olefin/paraffin diffusion through the 8-ring windows of zeolite SAPO-34 is characterized by a complementary set of first-principle molecular dynamics simulations, PFG-NMR experiments, and pulse-response temporal analysis of products measurements, yielding information at different length and time scales.
View Article and Find Full Text PDFHealth technology assessment bodies in several countries, including Japan and the United Kingdom, recommend mapping techniques to obtain utility scores in clinical trials that do not have a preference-based measure of health. This study sought to develop mapping algorithms to predict EQ-5D-3L scores from the Kansas City Cardiomyopathy Questionnaire (KCCQ) in patients with heart failure (HF). Data from the randomized, double-blind PARADIGM-HF trial were analyzed, and EQ-5D-3L scores were calculated using the Japanese and UK value sets.
View Article and Find Full Text PDFTo evaluate changes in health-related quality of life (HRQoL) in a Phase II trial (NCT02155647) of treatment-naive patients with metastatic Merkel cell carcinoma treated with avelumab (15-month follow-up). Mixed-effect Models for Repeated Measures were applied to HRQoL data (FACT-M; EQ-5D-5L) to assess changes over time. Clinically derived progression-free survival was compared with HRQoL deterioration-free survival.
View Article and Find Full Text PDFNanoscale open spaces formed by partial overlap of two-dimensional nanosheets in clays, abundantly and ubiquitously available, possess reactive molecular sites such as nanosheet edges in their interior. Here, the capture and storage of CO molecules in open spaces within saponite clay are explored by solid-state nuclear magnetic resonance coupled with open space analysis using positronium. CO physisorption occurs on the nanosheet surfaces inside the open spaces under ambient conditions.
View Article and Find Full Text PDFBackground: Botulinum neurotoxins type A (BoNT-As) are commonly used treatments for cervical dystonia (CD). Clinical trials have demonstrated the benefits of them in these patients, but data from real-life clinical practice as well as comparative data on the cost and outcome of different BoNT-A formulations are limited. The aim of this study was to compare abobotulinumtoxinA (aboBoNT-A) and onabotulinumtoxinA (onaBoNT-A) on their clinical outcomes and drug costs in real-life clinical practice.
View Article and Find Full Text PDF: Immunocompromised subjects are at increased risk for herpes zoster (HZ) and HZ-related complications, such as post-herpetic neuralgia (PHN). We describe health utilities, health care resource utilization (HCRU), productivity loss and health care costs in recipients of autologous hematopoietic stem-cell transplantation (Auto-HSCT) who developed confirmed HZ in the phase 3 clinical trial. : HCRU, costs, and EQ-5D-3L utility were assessed for 155 confirmed HZ cases observed after receiving inactivated varicella-zoster virus (VZV) vaccine (ZV) or placebo.
View Article and Find Full Text PDFBackground: Currently, there are 4 EQ-5D-5L scoring algorithms available for the United Kingdom that can be used to derive a utility score.
Objectives: To perform a psychometric validation of the EQ-5D utility score in patients with metastatic Merkel cell carcinoma (mMCC) and to compare 4 EQ-5D-5L value sets currently available for the United Kingdom.
Methods: Data collected in the phase 2 trial JAVELIN Merkel 200 were analyzed, in which 88 patients with mMCC were treated with avelumab.
Objective: Matching-adjusted indirect comparison (MAIC) can be used to assess the comparative effectiveness of two treatments indirectly using data from randomized placebo-controlled trials. This MAIC assessed the comparative effectiveness of secukinumab (an anti-interleukin-17A) and etanercept (a tumor necrosis factor inhibitor) in a target population of biologic-naïve patients with psoriatic arthritis (PsA).
Methods: Individual patient data pooled from FUTURE 2 (NCT01752634), FUTURE 3 (NCT01989468), and FUTURE 5 (NCT02404350) (secukinumab: 150 mg, n=458 and 300 mg, n=461) were matched to data from the population in the NCT00317499 trial (etanercept 25 mg, n=101) using MAIC methodology, by adjusting for clinical and demographic baseline characteristics.
Introduction: Complex underlying risk functions associated with immuno-oncology treatments have led to exploration of different methods (parametric survival, spline, landmark, and cure-fraction models) to estimate long-term survival outcomes. The objective of this study was to examine differences in estimated short- and long-term survival in previously treated metastatic Merkel cell carcinoma (mMCC) patients receiving avelumab, when using alternative extrapolation approaches.
Methods: Efficacy data from the phase 2 JAVELIN Merkel 200 trial (part A) with at least 12 months of follow-up were analyzed.
Pentacoordinated Al (Al) species in silica-alumina are promising to promote the formation of acid sites or act as surface defects for tailoring single-atom catalysts. However, pentahedral coordination (Al) is rarely observed in conventionally prepared silica-alumina. Here, we show that high population and dispersion of Al species on the surface of amorphous silica-alumina (ASA) can be achieved by means of flame spray pyrolysis.
View Article and Find Full Text PDFBackground: In the phase IIIb PROMID study, octreotide long-acting significantly extended time to tumor progression compared with placebo in treatment-naïve patients with well-differentiated metastatic midgut neuroendocrine tumors. We report post hoc analyses for health-related quality of life (HRQoL).
Methods: HRQoL was measured with EORTC QLQ-C30, a 30-item self-report questionnaire (5 functional, 1 global, 9 symptom scales).
To compare secukinumab with infliximab in biologic-naive patients with psoriatic arthritis using matching-adjusted indirect comparison. Individual patient baseline data for secukinumab were matched to published aggregate data for infliximab by key baseline characteristics, with matching weights determined by logistic regression, and used to recalculate American College of Rheumatology (ACR) responses for secukinumab, for comparison with infliximab. There were no differences in outcomes between secukinumab and infliximab at weeks 6/8 and 14/16.
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