Risk perception of IQOS™ and cigarettes: Temporal and cross-country comparisons.

Background: Risk perception (RP) is central to smokers' decision to switch to smoke-free tobacco and nicotine products (TNP). This study assessed temporal trends in the health RP of a novel heated tobacco product, IQOS TM , relative to cigarettes, among current IQOS TM users. Methods: The analyses included repeated cross-sectional data from online surveys in Germany (2018-19), Italy (2018-19), and Japan (2016-17, 2017-18, and 2018-19) among a random sample of current adult IQOS TM users from local registers of IQOS TM users. The health RPs of cigarettes and IQOS TM were assessed using the ABOUT™-Perceived Risk instrument, and their difference was described as the relative RP of IQOS TM to cigarettes (RPCig: IQOS TM ). Results: After adjustment for covariates, the relative RPCig: IQOS TM was higher in 2018 than in 2019 (0.93; standard error, 0.33; P = 0.005). This was driven by an increase in the RP of IQOS TM over time in Italy (2018: 42.6 [95% CI, 41.6-43.5]; 2019: 44.4 [43.4-45.4]) and Japan (2017: 44.0 [43.1-44.9); 2018: 45.9 [45.2-46.7]; 2019: 48.6 [47.9-49.4]), while the RP of cigarettes remained stable. Conclusions: The relative RP of IQOS TM decreased over time, driven by an increase in the RP of IQOS TM , in agreement with epidemiological studies indicating a temporal reduction in the relative RP of smoke-free TNPs. Continued surveillance of the RP of novel TNPs is warranted to inform effective TNP risk communication and ensure that adults smokers who would otherwise continue to smoke understand the relative risks of novel TNPs.

Development and validation of a new instrument to measure perceived risks associated with the use of tobacco and nicotine-containing products.

BACKGROUND: Making tobacco products associated with lower risks available to smokers who would otherwise continue smoking is recognized as an important strategy towards addressing smoking-related harm. Predicting use behavior is an important major component of product risk assessment. In this context, risk perception is a possible factor driving tobacco product uptake and use. As prior to market launch real-world actual product use cannot be observed, assessing risk perception can provide predictive information. Considering the lack of suitable validated self-report instruments, the development of a new instrument was undertaken to quantify perceived risks of tobacco and nicotine-containing products by adult smokers, former smokers and never-smokers. METHODS: Initial items were constructed based on a literature review, focus groups and expert opinion. Data for scale formation and assessment were obtained through two successive US-based web surveys (n = 2020 and 1640 completers, respectively). Psychometric evaluation was based on Rasch Measurement Theory and Classical Test Theory. RESULTS: Psychometric evaluation supported the formation of an 18-item Perceived Health Risk scale and a 7-item Perceived Addiction Risk scale: item response option thresholds were ordered correctly for all items; item locations in each scale were spread out (coverage range 75-87%); scale reliability was supported by high person separation indices > 0.93, Cronbach's alpha > 0.98 and Corrected Item-Total Correlations > 0.88; and no differential item functioning was present. Construct validity evaluations met expectations through inter-scale correlations and findings from known-group comparisons. CONCLUSIONS: The Perceived Risk Instrument is a psychometrically robust instrument applicable for general and personal risk perception measurement, for use in different types of products (including cigarettes, nicotine replacement therapy, potential Modified Risk Tobacco Products), and for different smoking status groups (i.e., current smokers with and without intention to quit, former smokers, never smokers).

Developing fit-for-purpose self-report instruments for assessing consumer responses to tobacco and nicotine products: the ABOUT™ Toolbox initiative.

Background. Determining the public health impact of tobacco harm reduction strategies requires the assessment of consumer perception and behavior associated with tobacco and nicotine products (TNPs) with different exposure and risk profiles. In this context, rigorous methods to develop and validate psychometrically sound self-report instruments to measure consumers' responses to TNPs are needed. Methods. Consistent with best practice guidelines, including the U.S. Food and Drug Administration's "Guidance for Industry Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims," scientifically designed, fit-for-purpose, reliable, and valid instruments are now being applied to tobacco regulatory research. Results. This brief report presents the ABOUT™ Toolbox ( Assessment of Behavioral OUtcomes related to Tobacco and nicotine products) initiative. This communication: (1) describes the methodological steps followed for the development and validation of the measurement instruments included in the ABOUT™ Toolbox, (2) presents a summary of the high-priority tobacco-related domains that are currently covered in the ABOUT™ Toolbox (i.e., risk perception, dependence, product experience, health and functioning, and use history), and (3) details how the measurement instruments are made accessible to the scientific community. Conclusions. By making the ABOUT™ Toolbox available to the tobacco research and public health community, we envision a rapidly expanding knowledge base, with the goals of (1) supporting consumer perception and behavior research to allow comparisons across a wide spectrum of TNPs, (2) enabling public health and regulatory communities to make better-informed decisions for future regulation of TNPs, and (3) enhancing surveillance activities associated with the impact of TNPs on population health.

Selective modulation of auditory cortical alpha activity in an audiovisual spatial attention task.

Despite substantial research on attentional modulations of visual alpha activity, doubts remain as to the existence and functional relevance of auditory cortical alpha-band oscillations. It has been argued that auditory cortical alpha does not exist, cannot be measured noninvasively, or that it is dependent on visual alpha generators. This study aimed to address these remaining doubts concerning auditory cortical alpha. A magnetoencephalography study was conducted using a combined audiovisual spatial cueing paradigm. In each trial, a cue indicated the side (left or right) and the modality (auditory or visual) to attend, followed by a short lateralized auditory or visual stimulus. Participants were instructed to respond to the stimuli by a button press. Results show that auditory cortical alpha power is selectively modulated by the audiospatial, but not the visuospatial, attention task. These findings provide further evidence for a distinct auditory cortical alpha generator, which can be measured noninvasively.

Cortical dynamics of word recognition.

While functional neuroimaging studies have helped elucidate major regions implicated in word recognition, much less is known about the dynamics of the associated activations or the actual neural processes of their functional network. We used intracerebral electroencephalography recordings in 10 patients with epilepsy to directly measure neural activity in the temporal and frontal lobes during written words' recognition, predominantly in the left hemisphere. The patients were presented visually with consonant strings, pseudo-words, and words and performed a hierarchical paradigm contrasting semantic processes (living vs. nonliving word categorization task), phonological processes (rhyme decision task on pseudo-words), and visual processes (visual analysis of consonant strings). Stimuli triggered a cascade of modulations in the gamma-band (>40 Hz) with reproducible timing and task-sensitivity throughout the functional reading network: the earliest gamma-band activations were observed for all stimuli in the mesial basal temporal lobe at 150 ms, reaching the word form area in the mid fusiform gyrus at 200 ms, evidencing a superiority effect for word-like stimuli. Peaks of gamma-band activations were then observed for word-like stimuli after 400 ms in the anterior and middle portion of the superior temporal gyrus (BA 38 and BA 22 respectively), in the pars triangularis of Broca's area for the semantic task (BAs 45 and 47), and in the pars opercularis for the phonological task (BA 44). Concurrently, we observed a two-pronged effect in the prefrontal cortex (BAs 9 and 46), with nonspecific sustained dorsal activation related to sustained attention and, more ventrally, a strong reflex deactivation around 500 ms, possibly due to semantic working memory reset.

The neural bases of attentive reading.

Recent studies have suggested that attention facilitates the formation of synchronous neural assemblies in the gamma range (>40 Hz) to amplify behaviorally relevant signals. Whether this mechanism is general or confined to sensory cortices is still a matter of debate, since there is little evidence of a direct link between attention and increased gamma synchronization in high-level brain regions. We recorded the intracerebral EEG of 10 epileptic patients while manipulating their attention during reading, and compared the neural responses to attended and unattended words. Visual presentation of attended words induced gamma band responses in the major brain regions associated with reading and those responses were attenuated for unattended words. The attenuation was not uniform within the reading network but followed a gradient from the posterior visual to the frontal areas. Altogether, these results support the view that the gamma band response can be used as a quantitative marker of attention.

Neural correlates of consolidation in working memory.

Many of our daily activities rely on a brain system called working memory, which implements our ability to encode information for short-term maintenance, possible manipulation, and retrieval. A recent intracranial study of patients performing a paradigmatic working memory task revealed that the maintenance of information involves a distributed network of oscillations in the gamma band (>40 Hz). Using a similar task, we focused on the encoding stage and targeted a process referred to as short-term consolidation, which corresponds to the encoding of novel items in working memory. The paradigm was designed to manipulate the subjects' intention to encode: series of 10 letters were presented, among which only five had to be remembered, as indicated by visual cues preceding or following each letter. During this task we recorded the intracerebral EEG of nine epileptic patients implanted in mesiotemporal structures, perisylvian regions, and prefrontal areas and used time-frequency analysis to search for neural activities simultaneous with the encoding of the letters into working memory. We found such activities in the form of increases of gamma band activity in a set of regions associated with the phonological loop, including the Broca area and the auditory cortex, and in the prefrontal cortex, the pre- and postcentral gyri, the hippocampus, and the fusiform gyrus.

A specific role for efferent information in self-recognition.

We investigated the specific contribution of efferent information in a self-recognition task. Subjects experienced a passive extension of the right index finger, either as an effect of moving their left hand via a lever ('self-generated action'), or imposed externally by the experimenter ('externally-generated action'). The visual feedback was manipulated so that subjects saw either their own right hand ('view own hand' condition) or someone else's right hand ('view other's hand' condition) during the passive extension of the index finger. Both hands were covered with identical gloves, so that discrimination on the basis of morphological differences was not possible. Participants judged whether the right hand they saw was theirs or not. Self-recognition was significantly more accurate when subjects were themselves the authors of the action, even though visual and proprioceptive information always specified the same posture, and despite the fact that subjects judged the effect and not the action per se. When the passive displacement of the participants right index finger was externally generated, and only afferent information was available, self-recognition performance dropped to near-chance levels. Differences in performance across conditions reflect the distinctive contribution of efferent information to self-recognition, and argue against a dominant role of proprioception in self-recognition.