Designing Studies to Inform Tobacco Harm Reduction: Learnings From an Oral Nicotine Pouch Actual Use Pilot Study.

BACKGROUND: Introduction of new tobacco products in the United States, including those that may be lower on the risk continuum than traditional combustible cigarettes, requires premarket authorization by the US Food and Drug Administration and information on the potential impact of the products on consumer behaviors. Efficient recruitment and data capture processes are needed to collect relevant information in a near-to-real-world environment. OBJECTIVE: The aim of this pilot study was to develop and test a protocol for an actual use study of a new tobacco product. The product included in this study was a commercially available oral nicotine pouch. Through the process of study design and execution, learnings were garnered to inform the design, execution, analysis, and report writing of future full-scale actual use studies with tobacco products. METHODS: A small sample (n=100) of healthy adult daily smokers of 7 or more cigarettes per day were recruited to participate in an 8-week prospective observational study conducted at 4 geographically dispersed sites in the United States. A smartphone-based customized electronic diary (eDiary) was employed to capture daily tobacco product use, including 1 week of baseline smoking and 6 weeks during which participants were provided with oral nicotine pouches for use as desired. RESULTS: Online screening procedures with follow-up telephone interviews and on-site enrollment were successfully implemented. Of 100 participants, 97 completed the study, with more than half (59/99, 60%) identifying as dual- or poly-users of cigarettes and other types of tobacco products at baseline. There was more than 90% (91-93/99, 92%-94%) compliance with daily eDiary reporting, and the majority (92/99, 93%) of participants expressed satisfaction with the study processes. Product use data from the eDiary indicated that after an initial period of trial use, pouches per day increased among those continuing to use the products, while per day average cigarette consumption decreased for 82% (79/97) of all study participants. At the end of the week 6, 16% (15/97) of participants had reduced their cigarette consumption by more than half. CONCLUSIONS: The design of this study, including recruiting, enrollment, eDiary use, and oversight, was successfully implemented through the application of a detailed protocol, a user-friendly eDiary, electronically administered questionnaires, and remote monitoring procedures. High-resolution information was obtained on prospective changes in tobacco product use patterns in the context of availability of a new tobacco product. Future, larger actual use studies will provide important evidence supporting the role that alternatives to combustible cigarettes may play in smoking reduction and/or cessation and lowering the population health burden of tobacco and nicotine-containing products.

'Kindness and empathy beyond all else': Challenges to professional identities of Higher Education teachers during COVID-19 times.

COVID-19 has continued to effect higher education globally in significant ways. During 2020, many institutions shifted learning online overnight as the sector closed its doors and opened new sites for remote teaching. This article reports on an international study [Phillips et al., 2021] that sought to capture how cross-sectoral teachers experienced these emergency changes during the first months of restrictions. The data, analysed using narrative identity theory, revealed concerns that fall into two broad categories: technologies and relationships. Significantly, it was not a loss of content delivery or changes to assessment that prompted the greatest anxiety for our colleagues, but that they held significant concerns about their students' mental health; inequities of access to a range of services including technological; and challenges connecting emotionally with their students at a distance. The results provide actionable strategies for higher education institutions to apply in future emergencies where remote teaching is necessary.

Surveying and resonating with teacher concerns during COVID-19 pandemic

The COVID-19 pandemic jolted teachers to the front line of complex, under resourced negotiation of quality distance learning, whilst also being key communicators with students and families about how to be COVID safe. Media reports debated preschool and school closures and child safety, but scarcely considered teachers. Motivated by the silencing of teachers and extraordinary changes to education, we gathered as a group of nine educational researchers located in Australia, New Zealand, Singapore and U.S.A to create a survey platform for teachers’ lived experiences of the impact of COVID-19. Our survey asked 22 questions and attracted 624 responses. This article focuses on question 12: What are the issues you are struggling with and need support with? Drawing from Latour’s provocation we distil key ‘matters of concern’ from the data, illustrated by excerpts from teacher responses and echoed by the authors’ COVID lived experiences as interwoven blackout poetry. Our collated experiences highlight struggles with online learning, connectivity/communication with students and families, quality of teaching, and workload, and the need to value and invest in education and the professionalism of teachers to address these struggles. [ABSTRACT FROM AUTHOR] Copyright of Teachers & Teaching is the property of Routledge and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)