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Background: Allergic rhinitis (AR) is a highly prevalent disease. We aimed to assess the symptoms that physicians who see patients with AR perceive as the most bothersome in their patients. Methods: We performed a cross-sectional study based on an online questionnaire sent to all members of the Allergic Rhinitis and its Impact on Asthma (ARIA) initiative. The survey included questions on the physicians' perceptions of patients’ AR symptoms as well as of their own AR symptoms. Results: Among 401 respondents, 155 (38.7%) reported having AR. ARIA members reported nasal symptoms to be the most frequent (89.7%) and bothersome (80.0%) symptoms experienced by themselves. Likewise, nasal symptoms were reported by ARIA members as the most frequent (94.8% in members with AR vs 96.0% in members without AR) and bothersome (57.0% in members with AR vs 67.9% in members without AR) in their patients. We found a significant association (p = 0.001) between physicians’ own symptoms and those perceived as the most bothersome in their patients. Conclusion: Physicians perceive nasal symptoms to be the most frequent and the most bothersome symptoms in AR patients. The physicians' personal experiences with AR may influence their perception of patients’ symptoms.

Epinephrine autoinjectors (EAIs) are used for the treatment of severe allergic reactions in a community setting; however, their utility is limited by low prescription fulfillment rates, failure to carry, and failure to use due to fear of needles. Given that delayed administration of epinephrine is associated with increased morbidity/mortality, there has been a growing interest in developing needle-free, easy-to-use delivery devices. neffy (epinephrine nasal spray) consists of three Food and Drug Administration (FDA)-approved components: epinephrine, Intravail A3 (absorption enhancer), and a Unit Dose Spray (UDS). neffy’s development pathway was established in conjunction with the FDA and the European Medicines Agency and included multiple clinical trials to evaluate pharmacokinetic and pharmacodynamic responses under a variety of conditions, such as self-administration and allergic and infectious rhinitis, as well as an animal anaphylaxis model of severe hypotension, where neffy demonstrated a pharmacokinetic profile that is within the range of approved injection products and a pharmacodynamic response that is as good or better than injections. The increased pulse rate (PR) and blood pressure (BP) observed even one minute following the administration of neffy confirm the activation of α and β adrenergic receptors, which are the key components of epinephrine’s mechanism of action. The results suggest that neffy will provide a safe and effective needle-free option for the treatment of severe allergic reactions, including anaphylaxis.

This study aimed to assess the impact of the margin applied to the clinical target volume, to create the planning target volume, on plan quality of a novel dysphagia-optimised intensity modulated radiotherapy technique developed within a head and neck cancer multicentre randomised controlled trial. Protocol compliant plans were used for a single benchmark planning case.Larger margins were associated with higher doses to adjacent organs at risk, particularly the inferior pharyngeal constrictor muscle, but coincided with some improved low dose target coverage. A 3 mm margin is recommended for this technique if local practices allow.

Abstract Background Patients with asthma uncontrolled on inhaled corticosteroids may benefit from umeclidinium (UMEC), a long-acting muscarinic antagonist. Methods This Phase IIb, double-blind study included patients with reversible, uncontrolled/partially-controlled asthma for ≥6 months, receiving ≥100 mcg/day fluticasone propionate (or equivalent) for ≥12 weeks. Following a 2-week run-in on open-label fluticasone furoate (FF) 100 mcg, patients were randomised (1:1:1) to receive UMEC 31.25 mcg, UMEC 62.5 mcg or placebo on top of FF 100 mcg once-daily for 24 weeks. As-needed salbutamol was provided. Primary and secondary endpoints were change from baseline in clinic trough forced expiratory volume in 1 s (FEV1) and clinic FEV1 3 h post-dose, respectively, at Week 24. Other endpoints included change from baseline in home daily spirometry (trough FEV1, evening FEV1, morning [pre-dose] and evening peak expiratory flow) over 24 weeks. Safety was assessed throughout the study. Results The intent-to-treat population comprised 421 patients (UMEC 31.25 mcg: n =139, UMEC 62.5 mcg: n =139, placebo: n =143). UMEC 31.25 mcg and 62.5 mcg demonstrated significantly greater improvements from baseline in clinic trough FEV1 at Week 24 (difference [95% CI]: 0.176 L [0.092, 0.260; p

Abstract Background The comparative efficacy of inhaled corticosteroid/long-acting muscarinic antagonist/long-acting β2-agonist (ICS/LAMA/LABA) triple therapy administered via single or multiple inhalers in patients with chronic obstructive pulmonary disease (COPD) has not been evaluated comprehensively. We conducted two replicate trials comparing single- with multiple-inhaler ICS/LAMA/LABA combination in COPD. Methods 207608 and 207609 were Phase IV, 12-week, randomized, double-blind, triple-dummy non-inferiority trials comparing once-daily fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) 100/62.5/25 μg via Ellipta inhaler, with twice-daily budesonide/formoterol (BUD/FOR) 400/12 μg via metered-dose inhaler plus once-daily tiotropium (TIO) 18 μg via HandiHaler. Patients had symptomatic COPD and forced expiratory volume in 1 s (FEV1)

Nonalcoholic fatty liver disease [NAFLD] is a condition affecting a vast portion of the worldwide population. The presence of underlying fibrosis is the strongest predictor of long-term outcomes and mortality, with a graduated increase in liver-related morbidity and mortality with progression from moderate fibrosis tobiomarkers targeting collagen turnover and extracellular matrix remodeling FibroTest FAST™, Velacur™, MRE]. While many of these provide a robust, stand alone value, the accuracy of these noninvasive tests markedly increase when used in combination or in sequential order with one another. There is not a uniform consensus demonstrating superiority of any specific test. Given the growing role and accuracy of these tests, they should have an expanding role in the assessment of fibrosis across this patient population and obviate the need for liver biopsy in a large portion of patients. Future clinical studies should focus on validating these novel biomarkers, as well as optimizing the sequential or algorithmic testing when combining these noninvasive tests.

BackgroundRacial and ethnic diversity in clinical trials for cancer treatment is essential for the development of treatments that are effective for all patients and for identifying potential differences in toxicity between different demographics. Mining of social media discussions about clinical trials has been used previously to identify patient barriers to enrollment in clinical trials; however, a comprehensive breakdown of sentiments and barriers by various racial and ethnic groups is lacking. ObjectiveThe aim of this study is to use an innovative methodology to analyze web-based conversations about cancer clinical trials and to identify and compare conversation topics, barriers, and sentiments between different racial and ethnic populations. MethodsWe analyzed 372,283 web-based conversations about cancer clinical trials, of which 179,339 (48.17%) of the discussions had identifiable race information about the individual posting the conversations. Using sophisticated machine learning software and analyses, we were able to identify key sentiments and feelings, topics of interest, and barriers to clinical trials across racial groups. The stage of treatment could also be identified in many of the discussions, allowing for a unique insight into how the sentiments and challenges of patients change throughout the treatment process for each racial group. ResultsWe observed that only 4.01% (372,283/9,284,284) of cancer-related discussions referenced clinical trials. Within these discussions, topics of interest and identified clinical trial barriers discussed by all racial and ethnic groups throughout the treatment process included health care professional interactions, cost of care, fear, anxiety and lack of awareness, risks, treatment experiences, and the clinical trial enrollment process. Health care professional interactions, cost of care, and enrollment processes were notably discussed more frequently in minority populations. Other minor variations in the frequency of discussion topics between ethnic and racial groups throughout the treatment process were identified. ConclusionsThis study demonstrates the power of digital search technology in health care research. The results are also valuable for identifying the ideal content and timing for the delivery of clinical trial information and resources for different racial and ethnic groups.

Introduction Endovascular thrombectomy is the standard of care for anterior circulation acute ischaemic stroke (AIS) secondary to emergent large vessel occlusion in patients who qualify. General anaesthesia (GA) or conscious sedation (CS) is usually required to ensure patient comfort and avoid agitation and movement during thrombectomy. However, the question of whether the use of GA or CS might influence functional outcome remains debated. Indeed, conflicting results exist between observational studies with better outcomes associated with CS and small monocentric randomised controlled trials favouring GA. Therefore, we aim to evaluate the effect of CS versus GA on functional outcome and periprocedural complications in endovascular mechanical thrombectomy for anterior circulation AIS.Methods and analysis Anesthesia Management in Endovascular Therapy for Ischemic Stroke (AMETIS) trial is an investigator initiated, multicentre, prospective, randomised controlled, two-arm trial. AMETIS trial will randomise 270 patients with anterior circulation AIS in a 1:1 ratio, stratified by centre, National Institutes of Health Stroke Scale (≤15 or >15) and association of intravenous thrombolysis or not to receive either CS or GA. The primary outcome is a composite of functional independence at 3 months and absence of perioperative complication occurring by day 7 after endovascular therapy for anterior circulation AIS. Functional independence is defined as a modified Rankin Scale score of 0–2 by day 90. Perioperative complications are defined as intervention-associated arterial perforation or dissection, pneumonia or myocardial infarction or cardiogenic acute pulmonary oedema or malignant stroke evolution occurring by day 7.Ethics and dissemination The AMETIS trial was approved by an independent ethics committee. Study began in august 2017. Results will be published in an international peer-reviewed medical journal.Trial registration number NCT03229148.

Category: Other Introduction/Purpose: The ability to accurately quantify a patient’s pain pre-operatively is advantageous in the preparation of post-operative expectations and pain management. The Numeric Pain Rating Scale (NPRS) is a popular method to identify patient pain level. Other patient reported outcomes are being collected, such as the Patient Reported Outcomes Measurement Information System (PROMIS) and has been suggested to be more accurate in measuring pain as well as physical function. The aim of this study was to 1) determine whether NPRS or PROMIS Pain Interference (PI) demonstrates a stronger association with physical function as determined by PROMIS Physical Function (PF) and 2) to determine which method better predicts post-surgical pain in a population of elective surgical foot and ankle patients. Methods: Prospective PROMIS PF, PI and NPRS (0-10) data was obtained for common foot and ankle elective surgical procedures (CPT codes 27698, 27870, 28285, 28289, 28300, 28705, 28730, 28750) from a multi-surgeon foot and ankle clinic between February 2015 until November 2017. Pearson correlation coefficients were used to determine the relationship between NPRS (0-10) and PROMIS domains (PI, PF) pre and post-operatively. Correlations were considered high (> 0.7), high moderate (0.6-0.69), moderate (0.4-0.6) or weak ( 6 month follow up were evaluated (74% women, mean age 54+/- SD, mean follow-up 14.4 months, range 6-34 months). Pearson correlation evaluation of NPRS and PI revealed a moderate correlation in the pre- and postoperative setting. There was a high moderate negative correlation between PI and PF t-scores pre and postoperatively suggesting more pain and less function. However, the negative correlation between NPRS and PF pre- and postoperatively was weak indicating a poor relationship between NPRS pain assessment and function. There was a moderate correlation between pre- and postoperative scores in all domains of PROMIS while the correlation between pre- and postoperative NPRS scores was weak. Conclusion: In a population of elective surgical foot and ankle patients, the use of both NPRS and PROMIS can be utilized to assess pain level, however the PROMIS PI domain demonstrated a stronger relationship with PROMIS PF than NPRS. Furthermore, only the PROMIS domains demonstrated at least a moderate correlation between pre- and post-operative scores. PROMIS PI provides superior assessment of pre- and post-operative physical function and prediction of post-operative pain. PROMIS PI can be used to gauge a patient’s pre-operative level of pain and function and aid the surgeon in guiding post-operative patient expectations and pain management.