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Accepted for/Published in: JMIR Research Protocols

Date Submitted: Oct 27, 2023
Date Accepted: Feb 19, 2024

The final, peer-reviewed published version of this preprint can be found here:

Tobacco Smoking or Nicotine Phenotype and Severity of Clinical Presentation at the Emergency Department (SMOPHED): Protocol for a Noninterventional Observational Study

Campagna D, Farsalinos K, Costantino G, Carpinteri G, Caponnetto P, Polosa R

Tobacco Smoking or Nicotine Phenotype and Severity of Clinical Presentation at the Emergency Department (SMOPHED): Protocol for a Noninterventional Observational Study

JMIR Res Protoc 2024;13:e54041

DOI: 10.2196/54041

PMID: 38657239

PMCID: 11079756

Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.

Relationship between tobacco and nicotine products use and clinical presentation at the Emergency Department: study protocol

  • Davide Campagna; 
  • Konstantinos Farsalinos; 
  • Giorgio Costantino; 
  • Giuseppe Carpinteri; 
  • Pasquale Caponnetto; 
  • Riccardo Polosa

ABSTRACT

Background:

In the last years several alternative to smoking nicotine products have become available. While laboratory and limited clinical studies suggest that these devices are less toxic compared to classic tobacco cigarettes, very little is still known about their epidemiological impact. Visiting the Emergency Department (ED) often represents the first or the only contact of patients with the healthcare system, so a study conducted at ED to assess the impact of these products on health is reliable and reflects the real life.

Objective:

The primary endpoint of the study is to assess the association between the NEWS score and product use phenotypes. Our hypothesis is that use of ENDS may be associated with lower NEWS the score compared to cigarette smoking. If our hypothesis will be confirmed, the study will be replicated as a multicentre study in order to validate our findings. Secondary outcomes will be hospital admissions (vs. discharge) and length of stay in the ED. Moreover, we will compare the prevalence of acute diseases known to be smoking related between the two groups, specifically stroke, acute myocardial infarction (AMI), peripheral artery diseases (PAD) chronic obstructive pulmonary disease (COPD), asthma and respiratory infections.

Methods:

This is an observational study with no intervention or randomization, analysing the association between of the health condition during an ED visit as well as the outcome (hospitalization and death) and different patterns of nicotine products use. Specifically, it will explore relevant associations according to the smoking, e-cigarette use and heated tobacco product use status (current, former and never use).

Results:

The study will be an observational study, with no intervention or randomization, to analyse the association between severity of clinical presentation during an ED visit as well as the outcome (hospitalization and death) and different patterns of nicotine products use. Approximately 1500-2000 people will be enrolled and categorized according to different pattern of tobacco and nicotine consumption through a specific questionnaire. Patient recruitment will start by the end of 2023. Results will be reported within 2024.

Conclusions:

There is a lot of 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 different nicotine product use and disease diagnosis and severity during an ED visit, and thus evaluate the harm reduction potential claims for these products. Clinical Trial: n/a


 Citation

Please cite as:

Campagna D, Farsalinos K, Costantino G, Carpinteri G, Caponnetto P, Polosa R

Tobacco Smoking or Nicotine Phenotype and Severity of Clinical Presentation at the Emergency Department (SMOPHED): Protocol for a Noninterventional Observational Study

JMIR Res Protoc 2024;13:e54041

DOI: 10.2196/54041

PMID: 38657239

PMCID: 11079756

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