Unravelling data for rapid evidence-based response to COVID-19: a summary of the unCoVer protocol

Introduction unCoVer—Unravelling data for rapid evidence-based response to COVID-19—is a Horizon 2020-funded network of 29 partners from 18 countries capable of collecting and using real-world data (RWD) derived from the response and provision of care to patients with COVID-19 by health systems across Europe and elsewhere. unCoVer aims to exploit the full potential of this information to rapidly address clinical and epidemiological research questions arising from the evolving pandemic. Methods and analysis From the onset of the COVID-19 pandemic, partners are gathering RWD from electronic health records currently including information from over 22 000 hospitalised patients with COVID-19, and national surveillance and screening data, and registries with over 1 900 000 COVID-19 cases across Europe, with continuous updates. These heterogeneous datasets will be described, harmonised and integrated into a multi-user data repository operated through Opal-DataSHIELD, an interoperable open-source server application. Federated data analyses, without sharing or disclosing any individual-level data, will be performed with the objective to reveal patients’ baseline characteristics, biomarkers, determinants of COVID-19 prognosis, safety and effectiveness of treatments, and potential strategies against COVID-19, as well as epidemiological patterns. These analyses will complement evidence from efficacy/safety clinical trials, where vulnerable, more complex/heterogeneous populations and those most at risk of severe COVID-19 are often excluded. Ethics and dissemination After strict ethical considerations, databases will be available through a federated data analysis platform that allows processing of available COVID-19 RWD without disclosing identification information to analysts and limiting output to data aggregates. Dissemination of unCoVer’s activities will be related to the access and use of dissimilar RWD, as well as the results generated by the pooled analyses. Dissemination will include training and educational activities, scientific publications and conference communications

Complex interrelations between self-reported oral health attitudes and behaviors, the oral health status, and oral health-related quality of life

Alexandra Lucia Vigu,1 Dorin Stanciu,2 Lucia Maria Lotrean,3 Radu Septimiu Campian4 1Department of Dental Materials and Ergonomics, “Iuliu Haţieganu” University of Medicine and Pharmacy, 2Department of Psychology and Pedagogy, Technical University of Cluj-Napoca, 3Department of Community Medicine, “Iuliu Haţieganu” University of Medicine and Pharmacy, 4Department of Oral Rehabilitation, Health and Management, “Iuliu Haţieganu” University of Medicine and Pharmacy, Cluj-Napoca, Romania Purpose: The purpose of this study was to develop and test a moderated mediation model that was able to describe the relationships between oral health-related attitudes and behaviors, oral health status (OHS), and oral health-related quality of life. The hypothesized relations corresponded to research questions such as “is a person’s oral health predicted by the actions that person takes in order to prevent oral health conditions?” and “do individuals with better oral health also have higher levels of oral health-related quality of life?”. Materials and methods: A cross-sectional correlational study with selected predictor variables was conducted in Cluj-Napoca, Romania, among 191 participants, enrolled in the fourth and sixth years of study at the Dentistry School of the Medicine and Pharmacology, University of Cluj-Napoca. Participants completed the Hiroshima University Dental Behavior Inventory (HUDBI) questionnaire targeting specific behavior and attitude with respect to their dental self-care, Oral Health Impact Profile (OHIP) short questionnaire for measuring oral health-related quality of life, and the current OHS was assessed objectively using Decayed, Missing, Filled Teeth/Surfaces (DMFT) index. Statistical analyses were done using structural equation modeling software. Results: Our research showed relevant associations between HUDBI, DMFT, and OHIP. The relationship between HUDBI and OHIP was mediated by DMFT. Furthermore, HUDBI worked as a moderator between DMFT and OHIP. Thus, our study revealed a case for moderated mediation, which is usually ignored in similar research. Conclusion: The “straightforward” causality between oral health-related behavior and the actual OHS must be considered with caution, as well as their impact on the oral health-related quality of life. Further research is needed to investigate the interaction between variables, the strength of the interrelations and the magnitude of their interactions, and the confidence that can be placed in these measurements, with respect to the general population and/or those lacking domain-specific education. Keywords: moderated mediation, oral health, HUDBI, oral health-related quality of life, DMF

Awareness and use of heated tobacco products among adult smokers in six European countries: Findings from the EUREST-PLUS ITC Europe Surveys

Background The study assessed awareness and use of heated tobacco products (HTPs) and factors that influenced these issues among cigarette smokers from six European countries in 2016 (wave 1) and 2018 (wave 2). Methods A survey was conducted among a nationally representative sample of cigarette smokers aged 18 years or older from Germany, Greece, Hungary, Poland Romania and Spain in 2016 (N= 6,011) and 2018 (N=6,027; 53% of smokers from the previous wave were retained, regardless of smoking status, and dropouts were replaced by a replenishment sample of smokers). Data were collected through face-to-face interviews. Estimates were produced using weighted data. The study presents the cross-sectional results. Results Awareness of HTPs increased from 8% to 17% between the two waves. At Wave 1, 1.1% of the smokers declared having used HTPs at least once during their lifetime, and at Wave 2 this increased to 1.9% (around 1% or less in four countries, except for Greece and Romania where it was around 4%). Factors associated with HTPs use among those who had ever heard about these products at Wave 1 were: country of residence, being a daily cigarette smoker, and ever use of electronic cigarettes. At wave 2 ever use of HTPs was significantly higher among those who had tried to quit smoking combustible cigarettes in the last 12 months, had tried electronic cigarettes during lifetime and perceived HTPs as less dangerous than combustible cigarette; the country of residence was also associated with HTPs use. Conclusion This study offers insights into the behaviours and perceptions of European adult smokers regarding HTPs, an important emerging issue in the field of tobacco control