The interest in online museum experiences and the influence of uncertainty and sentiment factors on tourist arrivals: The case of EU Mediterranean countries

This study examines the determinants of tourist arrivals at hotels and short-stay accommodations for nine EU countries from January 2010 to March 2022. We identify four driving channels of foreign and domestic tourism flows: a traditional, a sentiment, a technological and a health channel. The latter comprises two novel variables: the museum search interest and the infectious disease equity market volatility tracker. The results reveal that traditional and new drivers related to market sentiments and interest in online tourism experiences affect arrivals. Notably, there is a substitution effect between online and in-presence tourism, and the larger the uncertainty, the more substantial the reduction in tourist arrivals. COVID-19 has affected especially Spain and Italy and more foreign than domestic tourists. © 2023 The Authors

Trends and incidence of reported events associated with staplers: An analysis of the food and drug administration's manufacturer and user facility device experience database

Introduction & Objectives: To summarize medical device reports (MDRs) between 2012 and 2022 relating to staplers within the Manufacturer and User Facility Device Experience (MAUDE) database maintained by The Food and Drug Administration (FDA). Material(s) and Method(s): The MAUDE database was analyzed for all MDRs relating to each FDA-approved stapler for the last ten years. Event descriptions were reviewed and characterized into specific event types. Outcome measures include specific staplers and reported events as detailed by the MDRs. All data is de-identified and in compliance with the Health Insurance Portability and Accountability Act (HIPAA). No further data was available in the database. Pooled Relative risk was used to compare data. Result(s): Overall, 712 reports were retrieved in 10 years, between 2013 and 2015 a higher number of events were reported. In all, 413/712 (58%) were reported as malfunction of the device while 292/712 (41%) as injury. The most frequently reported adverse events (AEs) were Misfire (111/712: 15.6%), Failure to form staple (92/712: 12.9%), Mechanical jam (76/712: 10.7%) and Failure to fire (72/712: 10.1%). In terms of manufacturer: 401/712 (56%) were Covidien, 172/712 (24%) were Teleflex Medical and 139/712 (19.5%) were Ethicon Instruments. When comparing on disproportional analysis the different manufacturers, in terms of Misfire, Covidien presented the better profile when compared to Teleflex Medical and Ethicon (PRR= 0.32-0.65;p<0.05);in terms of failure to form staple Teleflex Medical presented the better profile when compared to Covidien and Ethicon (PRR 0.27-0.49;p<0.05);in terms of mechanical jam Covidien and Ethicon presented the best profile compared to Teleflex Medical (PRR 0.10-0.15;p<0.05). Lastly, in terms of failure to fire Teleflex presented the best profile (0% of events). Table 1: Trends and principal patient problems reported by the MAUDE database. Conclusion(s): Standing to MAUDE database the most frequent complications related to stapler are misfire, failure to form staple, mechanical jam and failure to fire. As well, the reported adverse events vary among the different manufacturers. [Figure presented]Copyright © 2023.

Toxicity profiles in a real-world cohort of head and neck cancer patients treated with nivolumab 240 mg every 14 days and/or 480 mg every 28 days during the COVID-19 pandemic

Background: Anti-PD-1 inhibitor Nivolumab (N) is approved for recurrent/metastatic head and neck carcinoma (R/M HNC) at the dose of 240 mg every 14 days (240q14);in Italy, N 480 mg every 28 days (480q28) is approved only in melanoma and renal carcinoma. During the COVID-19 pandemic, health authorities allowed the prescription of N 480q28 also for HNC to limit hospital access and patients (pts) infective risk. Available data on the safety of 480q28 derive from two subanalysis of mixed-histology clinical trials and pharmacokinetic models. Currently, there are no real-world data comparing immune-related adverse events (irAEs) between the two schedules in HNC pts. We conducted a retrospective study addressing this issue. Methods: We identified HNC pts consecutively treated with N at our HNC Oncology Unit between November 2018 and May 2021. Inclusion criteria were age = 18 years, R/M HNC (squamous cell HNC, sinonasal and nasopharyngeal cancers) diagnosis, ECOG PS 0-2, at least 2 N cycles. We collected clinical data and graded irAEs according to the CTCAE v.5. We compared the frequency of irAEs in pts treated either only with 240q14 cycles (A) or at least with one 480q28 cycle (B). Results: 47 cases were retrieved: schedule was A in 26, B in 21 pts (6 received 480 mg only, 12 switched from 240 to 480 mg, 3 from 480 to 240 mg). Median age was 61 y.o. (range 28-83), with male prevalence (72%). Median follow- up was 14.4 months and median treatment duration was 4.9 mo (0.5-23.4). Overall, all-grade irAEs occurred in 39 pts (83%), G3-4 in 5 pts (11%): 1 (4%) in A vs 4 (19%) in B group (p=0.16). The observed G3-G4 irAEs were pemphigoid (2 pts: 1 A, 1 B), lipase increase, atrial fibrillation, AST/ALT increase (1 each). No G3-G4 irAEs occurred in 6 pts (13%) who started N with low-dose prednisone (=10 mg) as concomitant medication. Among pts who started N in B schedule, 33% switched to A in order to optimize the clinical monitoring due to clinical conditions, not for G3-G4 irAEs. Conclusions: Aside from the COVID-19 pandemic contingency, a confirmation of N 480q28 approval for R/M HNC pts would optimize the treatment feasibility, particularly for the subgroup of fit patients who do not strictly require a q14 clinical monitoring. However, due to the trend towards an apparent higher toxicity with 480q28 schedule, special caution should be paid in selecting the most fit R/M HNC pts potentially benefiting from a monthly schedule in 2nd line. Further observation is needed to confirm these results.