Impact of the 2008 economic crisis on the burden of hepatitis B and C diseases in Southern European countries.

BACKGROUND: The economic crisis that began in 2008 has severely affected Southern (Greece, Italy, Portugal, Spain) Western European (SWE) countries of Western Europe (WE) and may have affected ongoing efforts to eliminate viral hepatitis. This study was conducted to investigate the impact of the economic crisis on the burden of HBV and HCV disease. METHODS: Global Burden of Diseases 2019 data were used to analyse the rates of epidemiological metrics of HBV and HCV acute and chronic infections in SWE and WE. Time series modelling was performed to quantify the impact of healthcare expenditure on the time trend of HBV and HCV disease burden in 2000-2019. RESULTS: Declining trends in incidence and prevalence rates of acute HBV (aHBV) and chronic HBV were observed in SWE and WE, with the pace of decline being slower in the post-austerity period (2010-2019) and mortality due to HBV stabilised in SWE. Acute HCV (aHCV) metrics and chronic HCV incidence and mortality showed a stable trend in SWE and WE, whereas the prevalence of chronic HCV showed an oscillating trend, decreasing in WE in 2010-2019 (p < 0.001). Liver cancer due to both hepatitis infections showed a stagnant burden over time. An inverse association was observed between health expenditure and metrics of both acute and chronic HBV and HCV. CONCLUSIONS: Epidemiological metrics for HBV and HCV showed a slower pace of decline in the post-austerity period with better improvement for HBV, a stabilisation of mortality and a stagnant burden for liver cancer due to both hepatitis infections. The economic crisis of 2008 had a negative impact on the burden of hepatitis B and C. Elimination of HBV and HCV by 2030 will be a major challenge in the SWE countries.

The state of health in the European Union (EU-27) in 2019: a systematic analysis for the Global Burden of Disease study 2019.

BACKGROUND: The European Union (EU) faces many health-related challenges. Burden of diseases information and the resulting trends over time are essential for health planning. This paper reports estimates of disease burden in the EU and individual 27 EU countries in 2019, and compares them with those in 2010. METHODS: We used the Global Burden of Disease 2019 study estimates and 95% uncertainty intervals for the whole EU and each country to evaluate age-standardised death, years of life lost (YLLs), years lived with disability (YLDs) and disability-adjusted life years (DALYs) rates for Level 2 causes, as well as life expectancy and healthy life expectancy (HALE). RESULTS: In 2019, the age-standardised death and DALY rates in the EU were 465.8 deaths and 20,251.0 DALYs per 100,000 inhabitants, respectively. Between 2010 and 2019, there were significant decreases in age-standardised death and YLL rates across EU countries. However, YLD rates remained mainly unchanged. The largest decreases in age-standardised DALY rates were observed for "HIV/AIDS and sexually transmitted diseases" and "transport injuries" (each -19%). "Diabetes and kidney diseases" showed a significant increase for age-standardised DALY rates across the EU (3.5%). In addition, "mental disorders" showed an increasing age-standardised YLL rate (14.5%). CONCLUSIONS: There was a clear trend towards improvement in the overall health status of the EU but with differences between countries. EU health policymakers need to address the burden of diseases, paying specific attention to causes such as mental disorders. There are many opportunities for mutual learning among otherwise similar countries with different patterns of disease.

Associations between adiposity measures and depression and well-being scores: A cross-sectional analysis of middle- to older-aged adults.

BACKGROUND: Obesity and mental health are significant global health concerns. Evidence has linked increased adiposity with depression and well-being; however, there is limited documented evidence in Ireland. Research also suggests lifestyle factors and disease conditions to be related to mental health. These may modulate relationships between adiposity and depression and well-being. METHODS: This was a cross-sectional study of 1,821 men and women aged 46-73 years, randomly selected from a large primary care centre. Depression and well-being were assessed using the 20-item Centre for Epidemiologic Studies Depression Scale (CES-D) and the World Health Organization-Five (WHO-5) Well-Being Index. Linear regression analyses were performed to examine relationships between mental health scores (dependent variable) and adiposity (independent variable) defined using body mass index (BMI) and waist-height ratio while adjusting for demographic characteristics, lifestyle factors and disease conditions. RESULTS: BMI and waist-height ratio had a significant positive association with depression scores and a significant inverse association with well-being scores in males and females. These associations were maintained following adjustment for demographic variables and lifestyle factors. In final models where disease conditions were adjusted for, BMI (ß = 0.743, p < .001) and waist-height ratio (ß = 0.719, p < .001) associations with the CES-D score remained significant. In stratified analyses, relationships between measures of adiposity and depression were found to be stronger in females (BMI: ß = 0.806, p = .007; waist-height ratio: ß = 0.768, p = .01) than males (BMI: ß = 0.573, p = .049; waist-height ratio: ß = 0.593, p = .044) but no effect modification was identified. CONCLUSIONS: These findings suggest that increased adiposity is significantly associated with poorer mental health, independent of lifestyle factors and disease conditions. Targeted interventions for reducing depression should include better population-level weight management measures.

Retrospective cohort study exploring the impact of universal Tuberculosis (TB) vaccination cessation on the epidemiology of paediatric TB in Ireland, 2011-2021.

BACKGROUND: Since 2010, Ireland's Tuberculosis (TB) crude incidence rate (CIR) remains below 10 per 100,000 population defining it as a low TB incidence country. Ireland maintained a universal BCG vaccination programme until its discontinuation in 2015 due to lack of vaccine supply. This study explores the impact of discontinuing a national universal BCG vaccination programme on the epidemiology of paediatric TB cases. METHODS: We retrospectively analysed TB notifications aged 0-6 years old reported to the Irish National TB Surveillance System between 2011 and 2021. Key epidemiological characteristics and temporal trends in TB age specific incidence rates (ASIRs) were compared between 0 and 6 year old cases born during a period of universal BCG vaccination (2007-2015) and 0-6 year old cases born after BCG vaccination ceased (2015-2021). RESULTS: No significant temporal trend was detected in the overall 0-6 year old ASIR by notification year during 2011-2021 (IRR:0.95; 0.86-1.1). However, the temporal trend for cases born during universal vaccination showed a significant decline (0.74; CIR: 0.62-0.89) while cases born after BCG vaccination ceased had a non-significant increase (1.2; CIR: 0.73-1.86). A significantly declining temporal trend was detected among cases born in Ireland during universal vaccination (IRR:0.73; 0.62-0.86), but no significant trend was detected in the cases born outside Ireland during universal vaccination (IRR:0.83; 0.53-1.31). No significant trend was detected in cases born after vaccination ceased in either cases born in Ireland (IRR:1.0; 0.60-1.65) or those born outside Ireland (IRR:0.64; 0.29-1.40). CONCLUSIONS: Universal BCG cessation has not yet directly impacted on TB cases among 0-6 year olds in Ireland. However, interruption of the previously declining temporal trend in this cohort during universal vaccination may be an early warning of a future increase. Paediatric TB cases remain an important cohort for timely surveillance to monitor trends in this primarily unvaccinated cohort to evaluate the long-term effects.

Suicide rates before and during the COVID-19 pandemic: a systematic review and meta-analysis.

PURPOSE: The effects of the COVID-19 pandemic on mental health issues such as depression and anxiety are well-documented in the literature, but its influence on suicidal patterns shows divergent results. We aim to comprehensively synthesize evidence on potential changes or stability of suicide rates during the COVID-19 pandemic worldwide. METHODS: A comprehensive search of studies reporting suicide rates before and during the COVID-19 pandemic was conducted. Eligible studies reported incidences of confirmed suicides (suspected in special cases) for two time periods, before (until February 2020) and during (from March 2020 to June 2021) the COVID-19 pandemic. A meta-analysis of proportions using a random-effect model was performed to estimate the pre- and during-pandemic incidence rates of suicide with 95% confidence intervals. Differences in pre- and during-pandemic rates were formally tested using a heterogeneity test. RESULTS: A total of 34 studies were included in the review capturing suicide data from over 40 countries and regions. The meta-analysis outputs did not indicate a significant change in suicide rates during the COVID-19 pandemic. The pooled suicide rate in the studied period before the pandemic was 11.38 per 100,000 (95% CI 9.35-13.42) and in the period during the pandemic was 10.65 per 100,000 (95% CI 8.61-12.68). CONCLUSION: No significant change in suicide rates was observed during the COVID pandemic from a global perspective for the periods examined. A longer follow-up can provide additional insights into such suicide trends globally. Improvements in data reporting, specifically with implementation of real-time surveillance, is imperative to provide adequate suicide prevention and support.

Untangling the association between COVID-19 health literacy, trust in the pandemic response, and mental distress, during the COVID-19 pandemic in Ireland: a repeated cross-sectional study.

BACKGROUND: The impact of the COVID-19 pandemic on rates of mental distress is well described. However, the contribution of poor health literacy and low levels of trust in state institutions to mental distress is less well defined. This study aimed to assess the impact of COVID-19 health literacy and trust in the pandemic response (Trust) on mental distress during the COVID-19 pandemic in Ireland. METHODS: We did this nationally representative cross-sectional survey of adult Irish residents during three study periods: from May 26 to June 17, 2020 (n=947); from July 1 to July 23, 2020 (n=995); and from Sept 5 to Sept 28, 2020 (n=972). Participants were contacted using random-digit-dialling and interviewed by a professional market research organisation (Ipsos MRBI' about 80% via mobile phone, 20% via landline). Mental distress was assessed by the Patient Health Questionnaire Anxiety Depression Scale (PHQ-ADS), for which a score of 10 or higher indicated mental distress. Heath literacy and trust were each assessed with three questions, which defined three categories: low, moderate, and high (appendix). Descriptive analysis and multivariate (MVA) Poisson regression were conducted in STATA17, Incidence Rate Ratios (IRR) are reported. FINDINGS: 2914 participants completed the survey across three study periods (median age 46 years, 1510 [51·8%] women, 1401 [48·1%] men, three [0·1%] non-binary). 804 (27·6%) of 2914 participants experienced mental distress (n=804). More women experienced mental distress than men (508 [34%] of women vs 294 [21%] of men). Mental distress was inversely associated with age (from 43% in those aged <30 years [n=232/539] to 19% in those aged >70 years [n=66/349]). Most participants had high health literacy (n=2,530, 86·8%). While health literacy was positively and significantly associated with trust, it was not associated with mental distress and it was therefore excluded from the MVA. Level of trust was captured for 2693 adults; 42·2% participants reported low trust (n=457) or moderate trust (n=679). The prevalence of mental distress was inversely associated with trust; increasing from 24% in those with high trust (n=374/1557), 30% in those with moderate trust (n=202/679), to 36% in those with low trust (n=166/457). In MVA higher rates of mental distress were associated with low trust (IRR 1·45, 95% CI 1·20-1·75; p=0·000) and moderate trust (IRR 1·24, 1·04-1·47, p=0·016) compared with high trust when adjusted for age, sex, employment status, and income,. INTERPRETATION: In Ireland, low levels of trust in the COVID-19 pandemic response were associated with higher levels of mental distress. Although poor health literacy was associated with low levels of trust, it was not independently associated with mental distress. Inference on the nature and direction of causal effects must be cautious given the cross-sectional study design. FUNDING: Health Research Board.

Comparing frailty prevalence between countries: validation of the Global Burden of Disease study Frailty Index (GBD-FI) in the survey of health, ageing and retirement in Europe.

BACKGROUND: Accurate comparable prevalence proportions are required to better understand the epidemiology of frailty. Estimates in many countries are missing or incomparable. The Global Burden of Disease Frailty Index (GBD-FI) applies the deficit accumulation model to generate frailty scores from items available in the Global Burden of Disease study. OBJECTIVE: To externally validate the GBD-FI. METHODS: Data were obtained from the Survey of Health Ageing and Retirement in Europe (SHARE). A 20-item modified GBD-FI was compared with established frailty measures: a 70-item frailty index (FI-70), the Clinical Frailty Scale (CFS), Frailty Phenotype (FP) and SHARE-FI. Area under receiver operating characteristic curves (AUC) were fitted to examine diagnostic accuracy for frailty and predictive validity for 2-year mortality. RESULTS: In total, 31,624 participants aged ≥50 years from 15 countries were included. Frailty prevalence was 22% using the GBD-FI (ranging from 8% in Switzerland to 41% in Poland). The GBD-FI had good to excellent diagnostic accuracy for frailty, irrespective of approach; the AUC ranged from 0.86 (95% confidence interval: 0.85-0.87) measuring frailty using the CFS to 0.94 (0.93-0.94) with the FI-70. The GBD-FI had similar accuracy for 2-year mortality (AUC 0.71, 0.69-0.74) compared with the CFS (0.73; P = 0.186), FP (0.73; P = 0.392) and SHARE-FI (0.70; P = 0.255) but lower than the FI-70 (0.76; P < 0.001). CONCLUSION: The GBD-FI demonstrated concurrent and predictive validity, suggesting it is a valid measure of frailty. It has the potential to be an efficient, replicable and consistent approach to comparing frailty between countries and regions across time using GBD data.

Smoking, betel quid chewing, and alcohol use among an indigenous primitive Tribal group in the Kerala State of India: Secondary analysis of a Tribal household survey.

Background: In India, indigenous populations, known as Tribes, are among the poorest and most marginalized groups. We estimated the prevalence of smoking, alcohol use, and betel quid chewing and examined the association between gender and smoking, alcohol use, and betel quid chewing among Kattunayakan primitive Tribes who are categorized as a Particularly Vulnerable Tribal Group (PVTG) in the Kerala State of India.Methods: A secondary analysis of a sample of the Wayanad District Tribal Household survey comprising 388 Kattunayakan PVTG households selected through multistage cluster random sampling was undertaken. Binary logistic regression models were used to estimate an association between gender and smoking, alcohol use, and betel quid chewing in these Tribal households.Results: Mean age was 39.2 years (±15.1), more than three-fourths of the respondents were female (75.3%), and approximately 24% of the respondents reported smoking tobacco in past 12 months. A fivefold increased odds of smoking among males compared to smoking among females was observed (OR = 4.92; p < .01). More than 64% reported betel quid chewing. Prevalence of alcohol use was 16%, which significantly varied between males (49%) and females (5.1%; OR = 17.71; p < .01). Among tobacco smokers, 64.1% were involved in betel quid use. Among alcohol users, 62.9% were involved in betel quid use and more than 58% were smoking tobacco. Betel quid chewing was the most prevalent substance use.Conclusion: Single and dual substance use of the three commonest types were disproportionately high among this hard-to-reach Tribal population in the southern state of India, with some gender variations. Alcohol consumption was relatively low. However, the complex nature of substance use, compounded by inaccessible health services, poses a significant challenge to rethink and to reimagine innovative methods of providing mental health care services, for instance, mobile health clinics.

Burden of infectious disease studies in Europe and the United Kingdom: a review of methodological design choices.

This systematic literature review aimed to provide an overview of the characteristics and methods used in studies applying the disability-adjusted life years (DALY) concept for infectious diseases within European Union (EU)/European Economic Area (EEA)/European Free Trade Association (EFTA) countries and the United Kingdom. Electronic databases and grey literature were searched for articles reporting the assessment of DALY and its components. We considered studies in which researchers performed DALY calculations using primary epidemiological data input sources. We screened 3053 studies of which 2948 were excluded and 105 studies met our inclusion criteria. Of these studies, 22 were multi-country and 83 were single-country studies, of which 46 were from the Netherlands. Food- and water-borne diseases were the most frequently studied infectious diseases. Between 2015 and 2022, the number of burden of infectious disease studies was 1.6 times higher compared to that published between 2000 and 2014. Almost all studies (97%) estimated DALYs based on the incidence- and pathogen-based approach and without social weighting functions; however, there was less methodological consensus with regards to the disability weights and life tables that were applied. The number of burden of infectious disease studies undertaken across Europe has increased over time. Development and use of guidelines will promote performing burden of infectious disease studies and facilitate comparability of the results.

Methodological considerations in injury burden of disease studies across Europe: a systematic literature review.

BACKGROUND: Calculating the disease burden due to injury is complex, as it requires many methodological choices. Until now, an overview of the methodological design choices that have been made in burden of disease (BoD) studies in injury populations is not available. The aim of this systematic literature review was to identify existing injury BoD studies undertaken across Europe and to comprehensively review the methodological design choices and assumption parameters that have been made to calculate years of life lost (YLL) and years lived with disability (YLD) in these studies. METHODS: We searched EMBASE, MEDLINE, Cochrane Central, Google Scholar, and Web of Science, and the grey literature supplemented by handsearching, for BoD studies. We included injury BoD studies that quantified the BoD expressed in YLL, YLD, and disability-adjusted life years (DALY) in countries within the European Region between early-1990 and mid-2021. RESULTS: We retrieved 2,914 results of which 48 performed an injury-specific BoD assessment. Single-country independent and Global Burden of Disease (GBD)-linked injury BoD studies were performed in 11 European countries. Approximately 79% of injury BoD studies reported the BoD by external cause-of-injury. Most independent studies used the incidence-based approach to calculate YLDs. About half of the injury disease burden studies applied disability weights (DWs) developed by the GBD study. Almost all independent injury studies have determined YLL using national life tables. CONCLUSIONS: Considerable methodological variation across independent injury BoD assessments was observed; differences were mainly apparent in the design choices and assumption parameters towards injury YLD calculations, implementation of DWs, and the choice of life table for YLL calculations. Development and use of guidelines for performing and reporting of injury BoD studies is crucial to enhance transparency and comparability of injury BoD estimates across Europe and beyond.

Estimating the Direct Disability-Adjusted Life Years Associated With SARS-CoV-2 (COVID-19) in the Republic of Ireland: The First Full Year.

Objectives: Burden of Disease frameworks facilitate estimation of the health impact of diseases to be translated into a single measure, such as the Disability-Adjusted-Life-Year (DALY). Methods: DALYs were calculated as the sum of Years of Life Lost (YLL) and Years Lived with Disability (YLD) directly associated with COVID-19 in the Republic of Ireland (RoI) from 01 March 2020, to 28 February 2021. Life expectancy is based on the Global Burden of Disease (GBD) Study life tables for 2019. Results: There were 220,273 confirmed cases with a total of 4,500 deaths as a direct result of COVID-19. DALYs were estimated to be 51,622.8 (95% Uncertainty Intervals [UI] 50,721.7, 52,435.8). Overall, YLL contributed to 98.5% of the DALYs. Of total symptomatic cases, 6.5% required hospitalisation and of those hospitalised 10.8% required intensive care unit treatment. COVID-19 was likely to be the second highest cause of death over our study's duration. Conclusion: Estimating the burden of a disease at national level is useful for comparing its impact with other diseases in the population and across populations. This work sets out to standardise a COVID-19 BoD methodology framework for the RoI and comparable nations in the EU.

Lip, Oral Cavity and Pharyngeal Cancer Burden in the European Union from 1990-2019 Using the 2019 Global Burden of Disease Study.

Background-The recent burden of lip and oral cavity, nasopharynx and other pharynx cancer (LOCP) has not been specifically investigated in Europe. Methods-In this descriptive epidemiological study, LOCP was categorised into lip and oral cavity cancer, nasopharynx cancer and other pharynx cancer, with European trends documented using the 2019 Global Burden of Disease (GBD). Summary statistics included deaths, age-standardised incidence rates (ASIR), mortality rates, YLLs (years of life lost), YLDs (years of life lived with disability) and DALYS (disability-adjusted life years). Results-Lip and oral cavity cancer (LO) is the most dominant with the incidence decreasing from 6.2 new cases per 100,000 (95% UI: 6.1-6.4) in 1990 to 5.3 new cases per 100,000 (95% UI: 4.6-6.1). However, nasopharynx cancer (NP) and other pharynx cancer (OP) increased from 1 and 2.2 new cases per 100,000 in 1990 to 1.1 and 3.3 new cases per 100,000 in 2019, respectively. It was noted that LOCP YLLs is much higher than YLDs. In Europe, eastern European countries, specifically Hungary, have the highest burden of LOCP. When LOCP attributable to tobacco in Ireland was compared with the EU, the percentage decrease in OP DALYs attributable to tobacco is below the EU average, whereas the percentage decrease in LO attributable to tobacco in Ireland was above the EU average. Conclusions-There has been a significant increase in ASIR in categories other pharynx and nasopharynx cancer since 1990, with significant geographic variations.

Tobacco Use Among People Incarcerated in Western Europe: A Systematic Review and Meta-analysis.

Background: Evidence suggests that the prevalence of tobacco use has declined significantly in the general population but still remains high among people incarcerated in high-income countries. Tobacco use is the second leading risk factor of mortality and morbidity worldwide. The objective of this study is to synthesize evidence on the prevalence of smoking among people incarcerated in Western European countries. Methods: We searched the PubMed database for articles published between June 2010 and June 2020, website of international organizations and hand-searching references. One author reviewed studies that met pre-defined inclusion criteria, and this was cross-validated by a second reviewer, following the MOOSE guidelines. The Meta prop command of Stata (V16) was used for pooling smoking prevalence estimates. Random effects modelling, heterogeneity with subgroup analysis and publication bias was assessed. Results: Out the 236 identified articles, 25 with full texts were eligible, and 16 were finally included in this study. The overall pooled estimate of smoking prevalence was 72.3%, 95% CI (54.8-84.7), and high heterogeneity (I2 = 99.73%). Females had a pooled prevalence 44.1% (95% CI 9.4-82.6) while males 83.3% (95% CI 72.0-92.1). The total number of prisoners combined in this study was 16,435 (ranging from 31-21,451) with age ranging from 24-43 years. Conclusion: A relatively high smoking rate was observed among incarcerated people - higher among the male population. The study findings are useful for informing policy-makers of the existing burden of smoking in special vulnerable populations across Western Europe-and the need for comprehensive tobacco control policies in different population settings.

Oral health literacy among third-level university students in cork city; Ireland.

INTRODUCTION: Health literacy is considered a social determinant of population health, but also relates to making informed health decisions. Little information is available on the oral health literacy (OHL) among young adults, and this is crucial to inform targeted interventions on oral health and care. AIMS: This study (i) estimates the prevalence of OHL among the third-level university students in Cork City and (ii) identifies determinants of OHL by exploring potential correlates. METHODS: All students in University College Cork (~ 21000) were sent out a previously validated questionnaire through the online Lime Survey in April 2018 (n = 1487). Both descriptive and inferential statistics (chi-squared/correlation) were undertaken. OHL score was calculated as adequate (2.1-3.0), marginal (1.1-2.0) or inadequate (0.0-1.0) in regard to the scores attained by the individuals. RESULTS: Adequate OHL prevalence was 23%. OHL was significantly correlated with age (r = 0.10), major discipline (r = - 0.13) and frequency of dental visits (r = - 0.08). Male gender, younger age group and those in non-medical schools had significantly higher inadequate OHL. CONCLUSION: Approximately, one-in-four third-level university students in Cork City have adequate OHL which is lower compared to the general Irish population but still significantly high in specific groups.

Country Participation in the WHO Framework Convention on Tobacco Control Health Warnings Database.

BACKGROUND: The World Health Organization's (WHO) Framework Convention on Tobacco Control (FCTC) Health Warnings Database is an online, publicly available resource created for countries to upload and share pictorial health warnings for tobacco packaging. The purpose of this study was to evaluate the extent to which the database is used by countries for the sharing of pictorial warnings. METHODS: The study's sample included parties to the FCTC who required graphic health warning labels on cigarette packaging from. Those countries were categorized as having a low, middle, and high Socio-Demographic Index (SDI). The Health Warnings Database was then analyzed for those countries' unique pictorial images, as well as the number of pictorials that were shared between countries. RESULTS: Of the 110 countries that required pictorial warnings on cigarette packaging, only 53 (48%) voluntarily contributed pictorials to the database, with most of those (53%) being high SDI-level countries. There were 342 unique pictorials on the database, with 62 images posted by seven countries that were used by 13 other countries. CONCLUSION: While sharing was evident from the database, there remains a need for more countries to upload the pictorials to the database. There is also a need to expand the database to include alternative tobacco products, such as waterpipe tobacco and e-cigarettes.

Quitline Information Included on Cigarette Packaging: An Assessment of Country Adherence to WHO FCTC Guidelines, 2007 to 2018.

The purpose of this study is to evaluate country adherence to the World Health Organization's (WHO) Framework Convention on Tobacco Control (FCTC) guidelines in terms of including quitline information on cigarette packaging. Data were gathered from the WHO's Global Health Observatory database. The study included countries that were signatories to the FCTC, had a toll-free quitline, and required health warnings on cigarette packaging. Countries were then classified by income level according to the World Bank. From 2007 to 2018, the number of countries that established a quitline increased from 34 to 60. During the same timeframe among those countries, the number of countries that included information about the quitline on cigarette packaging increased from 5 to 37, with a larger proportion (79%) of high-income countries promoting their quitlines on cigarette packaging compared to middle-income (45%) countries. Although there was an increase in adherence to the WHO FCTC guidelines, there is still a need for several countries to include quitline information on cigarette packaging.

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.