Development and validation of behavioral intention measures of an E-vapor product: intention to try, use, dual use, and switch.

BACKGROUND: The harm caused by tobacco use is primarily attributable to cigarette smoking. Switching completely to non-combustible products may reduce disease risks in adult cigarette smokers who are unable or unwilling to quit. Before a new tobacco product can enter the market or can be marketed as a modified risk tobacco product, the manufacturer must determine the impact that the product will have on the likelihood of changes in tobacco use behavior among both tobacco users and nonusers. One way to estimate change in tobacco use behavior is to assess tobacco users' and nonusers' behavioral intentions toward the product and its marketing, including intentions to try, use, dual use, and switch to the product from cigarettes. The purpose of this study was to develop and validate behavioral intention metrics appropriate for use with current, former, and never adult tobacco users. METHODS: Preliminary items were subjected to cognitive testing with adult (1) smokers planning to quit cigarettes in the next 30 days, (2) smokers not planning to quit cigarettes in the next 30 days, (3) e-vapor users, (4) former tobacco users, and (5) never tobacco users. Items were iteratively revised based on feedback during cognitive testing, and surviving items were administered to a large sample of adults (N = 2943) representing the aforementioned sub-groups. Rating scale functioning, reliability, validity, bias, and ability to detect change were evaluated. RESULTS: Examination of the response category thresholds generated by the Rasch model provided evidence that the rating scales were functioning appropriately. Results revealed good stability and excellent internal consistency and person reliability and provided evidence of unidimensionality and convergent validity. Estimates of reliability and validity were similar across sub-groups. A cross-validation sample generally confirmed findings from the validation sample. No items were discarded due to differential item function. Exploratory analyses provided support for ability to detect change. CONCLUSIONS: Results from this rigorous, empirical evaluation using large validation and cross-validation samples provide strong support for the psychometric properties of the Intention to Try, Use, Dual Use, and Switch scales with current, former, and never adult tobacco users.

Survey of maternal anxiety and perceptions towards foetal MRI and pre-scan education.

INTRODUCTION: Foetal MRI scans can induce feelings of fear, concern and anxiety in pregnant patients. The aim of this research was to determine if providing patients with an information leaflet reduced maternal anxiety regarding foetal MRI. METHODS: A prospective, three-arm comparative pilot study was performed in the MRI department of a quaternary public hospital in Brisbane, Australia. Three groups of 30 participants (total 90 participants) received differing levels of information about foetal MRI: Group A - no foetal-MRI specific information (current practice at the site); Group B - a basic information leaflet; Group C - a comprehensive information leaflet. All participants completed a survey that explored their pre-scan anxiety immediately after their MRI scan. RESULTS: Over 50% of participants in each group felt anxious before the MRI. Participants expressed anxiety towards the general process of the MRI, the outcome or results of the scan, and the safety of the modality. The basic and comprehensive leaflets were both efficacious in reducing anxiety for the majority of participants. CONCLUSIONS: Whilst not all patients express anxiety regarding MRI scans, emotional distress surrounding the entire process is prevalent. Providing patients with comprehensive information about what the MRI scan entails (including the scan environment and duration, positioning, breath-holding requirements, and foetal safety) reduces anxiety for most patients. These findings can be used to determine ways in which reduction of anxiety improves the patient experience.

Valomaciclovir versus valacyclovir for the treatment of acute herpes zoster in immunocompetent adults: a randomized, double-blind, active-controlled trial.

Herpes zoster is a common infectious disease that can result in significant acute and chronic morbidity. The safety and efficacy of once-daily oral valomaciclovir (EPB-348) was evaluated for non-inferiority to 3-times daily valacyclovir, an approved therapy. In this study, 373 immunocompetent adults with onset of a herpes zoster rash within the preceding 72 hr were randomly assigned to receive one of four treatments for 7 days: (1) EPB-348 1,000 mg once-daily; (2) EPB-348 2,000 mg once-daily; (3) EPB-348 3,000 mg once-daily; or (4) valacyclovir 1,000 mg 3-times daily. A 20% margin was the reference for non-inferiority assessment. For the primary efficacy measure of time to complete crusting of the zoster rash by Day 28, non-inferiority criteria were met for once-daily EPB-348 2,000 mg and once-daily EPB-348 3,000 mg compared to 3-times daily valacyclovir. Additionally, EPB-348 3,000 mg significantly shortened the time to complete rash crusting by Day 28 compared to valacyclovir. For secondary efficacy measures, non-inferiority was achieved for the EPB-348 1,000 and 2,000 mg groups compared to the valacyclovir group for time to rash resolution by Day 28. No EPB-348 group was non-inferior to valacyclovir for time to cessation of new lesion formation or time to cessation of pain by Day 120, though no significant differences occurred between treatment groups. Nausea, headache, and vomiting were the most common adverse events. Based on these results, additional studies are warranted to define further EPB-348's potential as an effective and safe therapy for acute herpes zoster.

Adherence and Health-Related Outcomes of Beginner Running Programs: A 10-Week Observational Study.

Purpose: This study aimed to explore the determinants of adherence and assess changes in fitness and health outcomes in participants of group-based beginner running programs. Methods: Participants completed adherence diaries (n = 34) during the 10-week program, and underwent fitness and health testing (n = 20) at the program start and end. Diaries included weekly visual analogue scales of enjoyment, motivation, confidence, fatigue, satisfaction, and support along with a record of training sessions. Space was provided for free-text comments. Fitness was assessed by the multi-stage 20-m shuttle run test, and measurements were taken of resting heart rate, blood pressure, body composition, and free-living physical activity. Results: Overall adherence to the 10-week program was 53 ± 27% with injury the most common reason for missing sessions and for discontinuing training. Adherence to group sessions was positively correlated with enjoyment, motivation, confidence, satisfaction with progress, and social support. Qualitative analysis of diary entries indicated three distinct themes (self-awareness, social support, personal challenge) underlying progression through the program. Significant changes were observed after 10 weeks in distance run on the fitness test (+189 ± 133 m), body mass index (-0.54 ± 0.72 kg/m2), and percentage body fat (-1.5 ± 1.6%). Blood pressure, resting heart rate, and physical activity were unchanged. Conclusion: Engagement in beginner running programs was associated with improvements in cardiorespiratory fitness and body composition within 10 weeks. A larger and longer-term study is required to determine if these programs can lead to sustained engagement in running and additional health benefits.

A general model of intake regulation.

Previously proposed models of intake regulation focus on specific variables thought to influence overall intake, and include factors involved in negative feedback loops with intake as well as genetic influences on intake. Recent evidence, however, suggests that these models although informative, are incomplete. They cannot account for the observations of prolonged and increasing deviations from defended levels, weakness and transitoriness of compensatory responses, the presence of powerful factors that are not compensated, and behavioral genetic data suggesting that there are a wide variety of independent genetic influences on numerous factors that influence intake. As a result we propose a new general model of intake regulation in which intake is influenced by both a set of uncompensated factors that are not influenced by intake and by a set of compensated factors that are. The preferred levels of intake and both sets of factors are specified as influenced by heredity. Further, the model includes impact factors, weights, which specify the magnitude of the effect each factor has on intake. The weights are assumed to be different for different individuals and their values are determined by heredity. A computer simulation of the new model demonstrated that it maintains different levels depending upon the external and internal environments, that changes in these environments result in new levels, and that inherited individual differences in responsiveness to these factors can markedly influence the levels obtained. The proposed general model appears to fit existing knowledge and is parsimonious and widely applicable. Future work should be directed to testing the general model and further developing specific models within the conceptual framework employing known physiological systems and uncompensated stimuli.