Characterization and Validation of Second Generation wPUM™ Topography Monitors.

INTRODUCTION Little is known about the natural use behavior of new and emerging tobacco products due to the limited availability of reliable puff topography monitors suitable for ambulatory deployment. An understanding of use behavior is needed to assess the health impact of emerging tobacco products and inform realistic standardized topography profiles for emissions studies. The purpose of this study is to validate four monitors: the wPUMTM cigalike, vapepen, hookah, and cigarette monitors. METHODS Each wPUMTM monitor was characterized and validated for range, accuracy and resolution for puff flow rate, duration, volume and interpuff gap in a controlled laboratory environment. Monitor repeatability was assessed for each wPUM monitor using four separate week-long natural environment monitoring studies including cigalike, vapepen, hookah and cigarette users. RESULTS The valid flow rate range was 10 to 100 ml/s for cigalike and cigarette monitors, 10 to 95 ml/s for vapepen monitors, and 50 to 400 ml/s hookah monitors. Flow rate accuracy was within ± 2 ml/s for cigalike, vapepen and cigarette monitors and ± 6 ml/s for the hookah monitor. Durations and interpuff gaps as small as 0.2 seconds were measured to within ± 0.07 seconds. Monitor calibrations changed by 4.7% (vapepen), 1.5% (cigarette), 0.5% (cigalike), and 0.1% (hookah) after 1 week of natural environment use. CONCLUSIONS The wPUMTM topography monitors were demonstrated to be reliable when deployed in the natural environment for a range of emerging tobacco products. IMPLICATIONS The current study addresses the lack of available techniques to reliably monitor topography in the natural environment, across multiple emerging tobacco products. Natural environment topography data will inform standardized puffing protocols for premarket tobacco product applications. The ability to quantify topography over extended periods of time will lead to a better understanding of use behavior and better informed regulations to protect public health.