Contextual Knowledge Core
Because Projects 1-4 involve manipulating ECIG device/liquid characteristics and/or collecting data from ECIG users, all require detailed and up-to-date knowledge of ECIG user behavior, as well as ECIG characteristics, effects and changing consumer and ECIG manufacturer/distributor behaviors. Changes can be rapid, so this information is often difficult to attain using data from annual national surveys. In this context, the overarching goal of the Contextual Knowledge Core (CKC) is to support each project by using a combination of concept mapping and online data sources to inform Projects 1-4 so testing conditions and data collection instruments reflect current, real-world conditions.
The team’s prior studies used several methods to understand ECIG effects and user and manufacturer behavior, using strategies such as a cost- and time-efficient participatory online method known as “concept mapping”; content analysis of a popular online video sharing site (YouTube); and systematic analyses of online forums, and manufacturer/distributor retail outlets to understand ECIG use behaviors, consumer engagement and industry labeling practices. Collectively, these methodological approaches can inform CSTP study designs, measurement instruments and hypotheses.
The CKC’s aims are to inform Projects 1-4 using: (1) concept mapping, (2) systematic and longitudinal surveillance of online data sources like YouTube and ECIG forms and (3) systematic and longitudinal surveillance of ECIG online retail sites. In sum, the CKC draws on the team’s proven expertise to ensure Projects 1-4 use detailed, up-to-date information to guide device/liquid manipulations and assessment instruments. As with prior studies, the CKC will produce novel, publishable information about real-world ECIG user experience as well as user and manufacturer/distributor behavior that will inform FDA about future regulatory action.