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).
Study population and design
Inclusion and exclusion criteria are summarized in Table 1. Participants will be recruited among patients presenting at ED of Policlinico Teaching Hospital of Catania, Italy in one month during the diurnal shift. Only patients that access ED for non-traumatic reason will be screened, since it is unlikely that smoking or use of other nicotine products can have any causal effect on accidents. Participants who meet the inclusion criteria will be recruited and administered an electronic questionnaire (see Appendix A) about their smoking and nicotine product use habits and their medical history. This questionnaire serves to typify the patient's use phenotype and quantify exposure to each product. A dedicated website will be created for the study. This website will respect the GDPR policy. Every study’s team member will access the site with personal and unique ID and password. The website will create two different databases to guarantee participants’ privacy. The first database will record fiscal code of the participant and will assign a unique ID. The second database will record anonymously the data from each participant using only the participant’s ID. It is necessary to create two databases so that additional information on outcomes or other missing data will be recorded at a later time.
Patients will be asked for authorization to use their clinical data in anonymous format, in accordance with the current privacy directives related to the access to the ED. The ERB approved informed consent form will be shown to participants who must be able to understand and sign it in order to participate in the study. All collected informed consents will be stored at the ED of Policlinico Teaching Hospital of Catania. No financial or other incentives will be provided to the participants. Since about 70 patients per day access the ED during the diurnal shift for non-traumatic reasons, we expect to enrol about 2000 participants in one month. Besides the aforementioned questionnaire, medical data at the triage phase such as the NEWS score, heart rate, blood pressure, SpO2, respiratory rate, temperature and FiO2 will be recorded. After the assessment and management of each patient in the ED, the final diagnosis, final disposition and colour code at discharge or admission to a ward will be recorded (see Table 2). In order not to compromise the health of patients with severe disease requesting urgent medical attention, potential participants who arrive in the ED in red code (severe acute illness) will be asked to participate after they are stabilized (questionnaire, NEWS score and vital signs will be recorded later).
Based on the responses to the questionnaire, phenotypes will be categorized as current, former and never use, separately for tobacco cigarettes, e-cigarettes and heated tobacco products. After one month, data in the eCRF will be extracted for the statistical analysis.
Since the ED is usually very crowded, four study team personnel will work on the study and will screen and recruit patients during the waiting period before medical examination. The study team will interview potential participants in a dedicated room within the ED area, to guarantee privacy. Initial survey will last about 5 minutes per patient. This is a reasonable time to collect product use information from each participant. After the medical visit and final disposition, compilation of the electronic case report form (eCRF) will be completed as provided by the study protocol, with each study member collecting all necessary information about the patients’ outcome (discharge, admission to a ward) by the end of their shift. Some patients can stay in the ED more than the length of diurnal shift, so data will be collected the day after. Some patient could access the ED two or more times during the study. In order to avoid double-entries, only the first visit will be included in the study. The website will reply with an error if we try to recruit for a 2nd time the same fiscal code (fiscal code is a unique identifying code ID in Italy and it is mandatory to be recorded for each patients during the triage phase in the ED).
Endpoint and outcomes
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.
Table 1
Inclusion and exclusion criteria for study participation.
Inclusion criteria | • Being an adult (age ≥ 18 years) • Ability to understand and sign informed consent |
Exclusion criteria | • Access in ED for traumatic accident • Pregnancy |
Table 2
Data to record in eCRF | Value |
Value of NEWS score calculated at the patient's triage phase (conventionally acute patients will be recorded as at high risk – NEWS score > 7) | From 0 up to 17 |
Vital signs (heart rate, blood pressure, SpO2, respiratory rate, temperature and FiO2) at the patient's triage phase | expressed in bpm, mmHg, %, rpm, °C and % respectively |
Smoking questionnaire | See appendix A |
Past Medical History and drugs | Textual |
Length of stay in the ED | expressed in hours and minutes |
Final diagnosis of discharged patients | Textual |
Final disposition | Admitted/Discharged |
Final diagnosis of admitted patients | ICD-9 codes |
Statistical analysis
Descriptive analysis will be performed by presenting numerical data as mean (standard deviation – SD) and categorical data as number (proportion - %). Patients will be classified according to product use as current, former and never users, separately for tobacco cigarettes, e-cigarettes and heated tobacco products.
Univariate comparisons will be made using chi-square tests for categorical variables and Kruskal Wallis H test for NEWS score. Regression analyses will be performed in order to examine the association between different product use and NEWS score as well as secondary outcomes. Demographics, including age, gender and educational level, as well as past medical history will be included in as independent variables. Since the majority of ENDS users report current or past smoking, the smoking status of these users will also be recorded along with those who not report any ENDS use. Therefore, the analysis will be adjusted for the smoking status of ENDS users. Additionally, secondary analyses will be performed for never-smoking ENDS users, if a sufficient number of such participants will be available. All analyses will be performed using SPSS v.25 (IBM, Chicago, IL, USA), and a P value of < 0.05 will be considered statistically significant.
Ethics and dissemination
The study will be conducted according to the principles of Good Clinical Practice and the Declaration of Helsinki. The institute ethics committee “Comitato Etico Catania 1” - Policlinico Teaching Hospital of Catania, Catania, Italy reviewed and approved the study. If any amendments to this protocol are required, the chief investigator will be responsible for the decision to amend the protocol and for deciding whether an amendment is substantial or non-substantial. Any substantial amendments will be submitted to the research ethics committee for approval before implementation. The informed consent from trial participants will be obtained by the investigators through relevant forms. All study members are independent and have no conflict of interest. The intention of the authors is to disseminate the results of the study through journal articles in high quality peer-reviewed journals and through conference abstracts.