| アブストラクト | 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. |
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| 投稿者 | La Rosa, Giusy Rita Maria; Del Giovane, Cinzia; Minozzi, Silvia; Kowalski, Jan; Chapple, Iain; Amaliya, Amaliya; Zakiawati, Dewi; Ludovichetti, Francesco Saverio; Kim, Baek Il; Tilakaratne, Wanninayake Mudiyanselage; Farsalinos, Konstantinos; Polosa, Riccardo |
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| 組織名 | Department of Clinical and Experimental Medicine, University of Catania, Catania,;Italy. Electronic address: giusy.larosa@unict.it.;Department of Medical and Surgical Sciences for Children and Adults,;University-Hospital of Modena and Reggio Emilia, Modena, Italy; Institute of;Primary Health Care (BIHAM), University of Bern, Bern, Switzerland.;Department of Epidemiology, Lazio Regional Health Service, Rome, Italy.;Department of Periodontology, Medical University of Warsaw, Warsaw, Poland.;Periodontal Research Group, Institute of Clinical Sciences, College of Medical &;Dental Sciences, The University of Birmingham, Birmingham, UK; Birmingham;Community Healthcare NHS Foundation Trust, Birmingham, UK.;Department of Periodontology, Faculty of Dentistry, Universitas Padjadjaran, West;Java, Indonesia.;Department of Oral Medicine, Faculty of Dentistry, Universitas Padjadjaran, West;Dentistry section, Department of Neuroscience, University of Padua, Padua, Italy.;Department of Preventive Dentistry & Public Oral Health, Yonsei University;College of Dentistry, Seoul, Republic of Korea.;Department of Oral and Maxillofacial Clinical Sciences, Faculty of Dentistry,;Universiti Malaya, Kuala Lumpur, Malaysia.;Department of Public and Community Health, School of Public Health, University of;West Attica, Athens, Greece.;Italy; Center for the Acceleration of Harm Reduction, University of Catania,;Catania, Italy. |
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