Oral adverse event reporting in smoking cessation trials using non-combustible nicotine products: A quality assessment

Giusy Rita Maria La Rosa; Cinzia Del Giovane; Silvia Minozzi; Jan Kowalski; Iain Chapple; Amaliya Amaliya; Dewi Zakiawati; Francesco Saverio Ludovichetti; Baek Il Kim; Wanninayake Mudiyanselage Tilakaratne; Konstantinos Farsalinos; Riccardo Polosa

doi:Objectives: To assess the completeness and quality of reporting of oral adverse events (OAEs) in randomized controlled trials (RCTs) that evaluated non-combustible nicotine products (NCNPs) and whether reporting practices have improved over time.

Data sources and study selection: This secondary data analysis was based on 36 RCTs included in a previous systematic review. Trials involved adult smokers and included nicotine replacement therapy, electronic cigarettes, heated tobacco, and smokeless tobacco. The OAE reporting was evaluated using an adapted CONSORT Harms checklist. An Adjusted Checklist Score (ACS), representing the proportion of criteria met, was calculated. Univariate linear regressions explored the association between ACS and study-level variables (publication year, country, funding, blinding and product type).

Results: OAE reporting was fragmented, with a mean ACS of 0.52 (0.11-0.74). Over 80 % of studies (n=30) provided some quantitative data, but only 53 % (n=19) presented results in a tabulated, arm-specific format. Definitions of OAEs and severity measurement were rarely reported (n=5, 14 % and n=6, 17 % respectively). The method of OAEs collection was described in 50 % of the studies (n=18). OAEs were rarely mentioned in titles (n=4, 11 %) and conclusions (n=13, 36 %). Less than half of the studies reported the reasons for participant withdrawal due to AEs (n=16, 44 %). Only 28 % (n=10) and 44 % (n=16) of the studies reported the analysis approach and statistical methods for AEs, respectively. A weak, non-significant positive correlation was found between ACS and year of publication (r = 0.288, p = 0.09). No study-level variable showed a statistically significant association with ACS.

Conclusions: Reporting of OAEs in clinical trials of NCNPs remains limited and inconsistent, often lacking clear definitions, standardized severity assessments, detailed data collection methods, and predefined statistical plans.

Clinical significance: Standardized OAE reporting is critical for tolerability data interpretation. We propose practical recommendations to guide researchers in improving the reporting of OAE and strengthening the role of dental professionals in supporting patients through smoking cessation strategies.

YUHSpace

BROWSE

0 1

Cited 0 times in

Oral adverse event reporting in smoking cessation trials using non-combustible nicotine products: A quality assessment

Authors: Giusy Rita Maria La Rosa ; Cinzia Del Giovane ; Silvia Minozzi ; Jan Kowalski ; Iain Chapple ; Amaliya Amaliya ; Dewi Zakiawati ; Francesco Saverio Ludovichetti ; Baek Il Kim ; Wanninayake Mudiyanselage Tilakaratne ; Konstantinos Farsalinos ; Riccardo Polosa

Citation: JOURNAL OF DENTISTRY, Vol.162 : 106057, 2025-08

Journal Title: JOURNAL OF DENTISTRY

ISSN: 0300-5712

Issue Date: 2025-08

MeSH: 1

Abstract: CONSORT harms; E-cigarette; Nicotine replacement therapy; Non-combustible nicotine products; Oral adverse events; Safety; Smoking cessation; Snus

Article Number: 10.1016/j.jdent.2025.106057

DOI: Objectives: To assess the completeness and quality of reporting of oral adverse events (OAEs) in randomized controlled trials (RCTs) that evaluated non-combustible nicotine products (NCNPs) and whether reporting practices have improved over time. Data sources and study selection: This secondary data analysis was based on 36 RCTs included in a previous systematic review. Trials involved adult smokers and included nicotine replacement therapy, electronic cigarettes, heated tobacco, and smokeless tobacco. The OAE reporting was evaluated using an adapted CONSORT Harms checklist. An Adjusted Checklist Score (ACS), representing the proportion of criteria met, was calculated. Univariate linear regressions explored the association between ACS and study-level variables (publication year, country, funding, blinding and product type). Results: OAE reporting was fragmented, with a mean ACS of 0.52 (0.11-0.74). Over 80 % of studies (n=30) provided some quantitative data, but only 53 % (n=19) presented results in a tabulated, arm-specific format. Definitions of OAEs and severity measurement were rarely reported (n=5, 14 % and n=6, 17 % respectively). The method of OAEs collection was described in 50 % of the studies (n=18). OAEs were rarely mentioned in titles (n=4, 11 %) and conclusions (n=13, 36 %). Less than half of the studies reported the reasons for participant withdrawal due to AEs (n=16, 44 %). Only 28 % (n=10) and 44 % (n=16) of the studies reported the analysis approach and statistical methods for AEs, respectively. A weak, non-significant positive correlation was found between ACS and year of publication (r = 0.288, p = 0.09). No study-level variable showed a statistically significant association with ACS. Conclusions: Reporting of OAEs in clinical trials of NCNPs remains limited and inconsistent, often lacking clear definitions, standardized severity assessments, detailed data collection methods, and predefined statistical plans. Clinical significance: Standardized OAE reporting is critical for tolerability data interpretation. We propose practical recommendations to guide researchers in improving the reporting of OAE and strengthening the role of dental professionals in supporting patients through smoking cessation strategies.

Appears in Collections:: 2. College of Dentistry (치과대학) > Dept. of Preventive Dentistry and Public Oral Health (예방치과학교실) > 1. Journal Papers

Yonsei Authors: Kim, Baek Il(김백일) https://orcid.org/0000-0001-8234-2327

URI: https://ir.ymlib.yonsei.ac.kr/handle/22282913/207433

사서에게 알리기

Show full item record Find it @ YMLIB

License

YUHSpace: Oral adverse event reporting in smoking cessation trials using non-combustible nicotine products: A quality assessment

YUHSpace

BROWSE

Browse

Links