Campagna Davide, Farsalinos Konstantinos, Costantino Giorgio, Carpinteri Giuseppe, Caponnetto Pasquale, Cucuzza Francesca, Polosa Riccardo
Department of Clinical and Experimental Medicine, University of Catania, Catania, Italy.
Center of Excellence for the Acceleration of Harm Reduction, University of Catania, Catania, Italy.
JMIR Res Protoc. 2024 Apr 24;13:e54041. doi: 10.2196/54041.
In the last few years, several nicotine products have become available as alternatives to smoking tobacco. While laboratory and limited clinical studies suggest that these devices are less toxic compared to classic tobacco cigarettes, very little is known about their epidemiological impact. Visiting the emergency department (ED) often represents the first or even the only contact of patients with the health care system. Therefore, a study conducted at the ED to assess the impact of these products on health can be reliable and reflect a real-life setting.
The aim of this noninterventional observational study (SMOPHED study) is to analyze the association between the severity of clinical presentation observed during ED visits among patients using various nicotine products and the subsequent outcomes, specifically hospitalization and mortality.
Outcomes (hospitalization and mortality in the ED) will be examined in relation to various patterns of nicotine products use. We plan to enroll approximately 2000 participants during triage at the ED. These individuals will be characterized based on their patterns of tobacco and nicotine consumption, identified through a specific questionnaire. This categorization will allow for a detailed analysis of how different usage patterns of nicotine products correlate with the clinical diagnosis made during the ED visits and the consequent outcomes.
Enrollment into the study started in March 2024. We enrolled a total of 901 participants in 1 month (approximately 300 potential participants did not provide the informed consent to participate). The data will be analyzed by a statistician as soon as the database is completed. Full data will be published by December 2024.
There is substantial debate about the harm reduction potential of alternative nicotine products in terms of their smoking-cessation and risk-reduction potential. This study represents an opportunity to document epidemiological data on the link between the use of different types of nicotine products and disease diagnosis and severity during an ED visit, and thus evaluate the harm reduction potential claims for these products.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/54041.
在过去几年中，出现了几种尼古丁产品作为吸烟的替代品。虽然实验室和有限的临床研究表明，与传统香烟相比，这些产品毒性较小，但对其流行病学影响却知之甚少。前往急诊科（ED）就诊往往是患者与医疗系统的首次甚至唯一接触。因此，在急诊科进行的一项评估这些产品对健康影响的研究可能是可靠的，并能反映现实生活中的情况。
这项非干预性观察性研究（SMOPHED研究）的目的是分析在急诊科就诊期间使用各种尼古丁产品的患者临床表现的严重程度与后续结果之间的关联，特别是住院率和死亡率。
将根据尼古丁产品的不同使用模式来检查结果（急诊科的住院率和死亡率）。我们计划在急诊科分诊期间招募约2000名参与者。这些个体将根据通过特定问卷确定的烟草和尼古丁消费模式进行特征描述。这种分类将有助于详细分析尼古丁产品的不同使用模式与急诊科就诊期间做出的临床诊断以及随后的结果之间的相关性。
该研究于2024年3月开始招募。我们在1个月内共招募了901名参与者（约300名潜在参与者未提供知情同意书参与）。数据库一完成，统计学家就将对数据进行分析。完整数据将于2024年12月公布。
关于替代尼古丁产品在戒烟和降低风险方面的潜在危害减少作用存在大量争议。这项研究提供了一个机会，可记录有关不同类型尼古丁产品使用与急诊科就诊期间疾病诊断和严重程度之间联系的流行病学数据，从而评估这些产品在减少危害方面的潜在作用。
国际注册报告识别码（IRRID）：PRR1-10.2196/54041。
