A Novel Puff Recording Electronic Nicotine Delivery System for Assessing Naturalistic Puff Topography and Nicotine Consumption During Ad Libitum Use: Ancillary Study
Notice bibliographique
Résumé
Background Assessing the naturalistic puff topography and associated nicotine consumption during e-cigarette use is important as such information will not only unveil how these products are being consumed in real-world conditions, but also enable investigators and regulatory bodies to conduct quantitative, accurate, and realistic harmful exposure and nicotine abuse liability risk assessments based on actual e-cigarette use. Conventional approaches cannot accurately, conveniently, and noninvasively determine e-cigarette puff topography in a natural use environment. Thus, novel technology-enabled systems that do not primarily rely on self-report mechanisms or intrusive measurements to monitor e-cigarette product use behaviors are highly desired. Objective This study aimed to explore and demonstrate the feasibility of a novel puff recording electronic nicotine delivery system (PR-ENDS) device for measuring naturalistic puff topography and estimating nicotine consumption during the ad libitum use of products among smokers and vapers. Methods An ancillary data analysis based on a completed parent study was conducted. The parent study was a 1-way randomized controlled open-label puff topography and nicotine pharmacokinetic assessment carried out in 24 healthy adults (12 smokers and 12 vapers). Participants were assigned a randomized product use sequence of a PR-ENDS device within 5 site visits for both controlled and ad libitum product use sessions. Blood samples were obtained for plasma nicotine analysis, and questionnaires were administered at various time points. During the ad libitum use session, puff topography was measured using a Clinical Research Support System (CReSS) device as a benchmark, as well as the PR-ENDS device with a built-in puff recording feature. Results There were no significant differences in representative puff topography parameters (number of puffs, total puff duration, and average puff duration) between the PR-ENDS and CReSS devices at the populational level across different device powers, e-liquid nicotine strengths, and flavors. The nicotine consumption estimated by the PR-ENDS device suggested that this device can be employed as a convenient monitoring tool for estimating nicotine use without measuring e-liquid weight loss between puffs. The linear relationship between nicotine consumption estimated by the PR-ENDS device and the pharmacokinetic parameter AUCad lib (plasma concentration-time curve for 1-hour ad libitum use) substantiated the potential of using this device as a pragmatic, noninvasive, and convenient means for estimating nicotine intake in the human body without blood collection. Conclusions The novel PR-ENDS device was feasible for assessing naturalistic puff topography and estimating nicotine consumption and intake in the human body during ad libitum use. Several key factors can influence users’ puff topography, including device power levels, e-liquid nicotine strengths, and flavors. The study results pave the way for further research in the real-time measurement of naturalistic puff topography and puffing behaviors in the real world.
Récupéré en direct depuis OpenAlex et désinversé. Les résumés ne sont pas conservés dans cette base de données : les index inversés représentent 8,6 Go des 9,3 Go de texte de la base, et le serveur dispose de 13 Go libres.
Comment cette classification a été obtenuedéplier
Prédiction machine sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Le volet Gemma est une étiquette directe du modèle pour chaque travail de la base, lue sur la notice réduite au titre. Le volet Codex est un classifieur appris des 10 348 étiquettes directes de Codex et calibré sur les taux pondérés de l'échantillon; les champs sans appui suffisant ne portent aucun appel Codex. Le mode candidate est l'union des deux volets; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont pas des étiquettes humaines.
Scores du classifieur distillé par catégorie (deux têtes)
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,002 | 0,002 |
| Méta-épidémiologie (sens strict) | 0,001 | 0,000 |
| Méta-épidémiologie (sens large) | 0,001 | 0,001 |
| Bibliométrie | 0,000 | 0,000 |
| Études des sciences et des technologies | 0,000 | 0,000 |
| Communication savante | 0,000 | 0,001 |
| Science ouverte | 0,001 | 0,001 |
| Intégrité de la recherche | 0,001 | 0,001 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,002 | 0,000 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découleClassification
machine, non validéePrédiction automatique; un appel candidat d’une seule source (Gemma direct ou Codex distillé), pas un consensus.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».