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Background: What leads healthy people to enter in a volunteer register for clinical trials? This study aimed to investigate the relationship between the decision to volunteer in clinical trials for a COVID-19 vaccine and social capital, in a sample of healthy volunteers in Italy. Since social capital is characterized by trust, reciprocity, and social and political participation, we claim that it is key in leading individuals to actively take action to protect public health, and to take a risk for the (potential) benefit not only of themselves but for the entire community., Methods: This study was conducted through the administration of a questionnaire to healthy volunteers registered for a phase 1 clinical trial for a COVID-19 vaccine in the Unit Research Centre of ASST-Monza, in September 2020. The primary purpose of a phase 1 study is to evaluate the safety of a new drug candidate before it proceeds to further clinical studies. To approximate a case-control study, we randomly matched the 318 respondents to healthy volunteers (cases) with 318 people randomly selected by Round 9 of the European Social Survey (controls), using three variables, which we considered to be associated with the decision to volunteer: gender, age, and education level. To execute this matching procedure, we used the "ccmatch" module in STATA., Results: The findings highlight the positive impact of social capital in the choice of healthy individuals to volunteer in COVID-19 vaccine clinical trials. Controlling for possible confounding factors, some exemplary results show that people with a high level of general trust have a greater likelihood of volunteering compared to people with low trust (OR = 2.75, CI = 1.58-4.77); we also found that it is more probable that volunteers are people who have actively taken action to improve things compared with people who have not (for individuals who did three or more actions: OR = 7.54, CI = 4.10-13.86). People who reported voting (OR = 3.91, CI = 1.70-8.99) and participating in social activities more than other people of their age (OR = 2.89, CI = 1.82-4.60) showed a higher probability to volunteer., Conclusions: Together with the adoption of urgent health measures in response to COVID-19, government policymakers should also promote social capital initiatives to encourage individuals to actively engage in actions aimed at protecting collective health. Our findings make an empirical contribution to the research on vaccines and its intersection with social behaviour, and they provide useful insights for policymakers to manage current and future disease outbreaks and to enhance the enrolment in vaccine trials., (© 2022. The Author(s).)

Backgrounds: Healthy volunteers play a key role in clinical trials and it is crucial to develop recruitment strategies that capitalise on their motivations and maximise their participation. The COVID-19 pandemic has shown the importance of finding motivated healthy volunteers for the development of new vaccines. Public registers represent a promising way to promote the participation of healthy volunteers in the research field, but their adoption is still limited. The current study aimed to explore the motivations of healthy volunteers to enrol in an Italian public register for clinical trials during the COVID-19 pandemic and their attitude toward participating in a phase 1 COVID-19 vaccine clinical trial. The impacts of different enrolling interview modalities (in person, by phone, by mail) on motivation, understanding of information and trust in researchers were also investigated., Methods: An online survey investigating experience with COVID-19, motivations to enrol, trust in researchers, political and healthcare authorities and pharmacological companies was presented to people applying as healthy volunteers in the public register for clinical trials at Phase 1 Unit Research Centre of ASST Monza, Italy, and considering to participate in a COVID-19 vaccine clinical trial. Data were collected in June 2021., Results: Altruistic motivations were the main driver for enrolling in the public register, while self-interested motivations were secondary. No gender differences were found. As for enrolling modalities, no differences emerged between in-person and interviews for motivation to enrol, understanding of information and trust in researchers. Email modality led to significantly lower volunteers' satisfaction and understanding of information but similar trust in research., Conclusions: This study supports the validity of different interview modalities (in person and by phone) for the enrolment of healthy volunteers for clinical trials and highlights the positive role of public registers for the recruitment procedures., (© 2022. The Author(s).)

Background: This study investigated changes in the prevalence of insomnia in Italy during COVID-19, starting from the first lockdown period (8 March 2020). We hypothesized that lockdown precipitated increased prevalence of insomnia symptoms relative to the pre-pandemic period; b) the gradual relaxation of containment measures - post-lockdown period (Phase 2 and Phase 3) - reduced insomnia severity, leading to a relative recovery of pre-pandemic levels; and c) we tested age-related heterogeneity in sleep responses, with an expected higher increase in insomnia in younger and middle-age groups., Methods: Analyses drew on a subsample (N = 883) of respondents to ITA.LI - Italian Lives, a recently established panel study on a probability sample of individuals aged 16 + living in Italy. To estimate patterns of change in insomnia, we first fitted a random-effects ordered logistic model on the whole sample. We then added an interaction term between policy phases and the respondent age to test whether the relationship between insomnia and policy phases differed across age groups. Analyses accounted for survey non-response weights., Results: The fraction of respondents reporting moderate ("somewhat" + 0.159, S.E. 0.017) or severe ("very much" + 0.142, S.E. 0.030) sleep disturbances significantly increased during Phase 1. The prevalence of insomnia followed an inverted U-shaped curve across policy phases, with further increases from baseline levels ("somewhat" + 0.168, S.E. 0.015; "very much" + 0.187, S.E. 0.030) during Phase 2, followed by a relative reduction in Phase 3, although it remained significantly higher than in the pre-pandemic period ("somewhat", + 0.084, S.E. 0.016; "very much", + 0.045, S.E. 0.010). There were significant age-related differences in insomnia patterns, as the discrete change from pre-pandemic levels in the probability of not suffering from insomnia was negative and significant for the younger age group (- 0.269, S.E. 0.060) and for respondents aged 35-54 (- 0.163, S.E. 0.039)., Conclusion: There is reason to believe that the emergency policy response to the COVID-19 crisis may have had unintended and possibly scarring effects in terms of increased prevalence of insomnia. The hardest hit were young adults and, to a lesser extent, the middle-aged; however, older respondents (55 +) remained resilient, and their insomnia trajectory bounced back to pre-pandemic levels., (© 2022. The Author(s).)

Background: In February 2021, the spread of a new variant of SARS-CoV-2 in the Lombardy Region, Italy caused concerns about school-aged children as a source of contagion, leading local authorities to adopt an extraordinary school closure measure. This generated a debate about the usefulness of such an intervention in light of the trade-off between its related benefits and costs (e.g. delays in educational attainment, impact on children and families' psycho-physical well-being). This article analyses the epidemiological impact of the school closure intervention in the Milan metropolitan area., Methods: Data from the Agency for Health Protection of the Metropolitan City of Milan allowed analysing the trend of contagion in different age classes before and after the intervention, adopting an interrupted times series design, providing a quasi-experimental counterfactual scenario. Segmented Poisson regression models of daily incident cases were performed separately for the 3-11-year-old, the 12-19-year-old, and the 20+-year-old age groups, examining the change in the contagion curves after the intervention, adjusting for time-varying confounders. Kaplan-Meier survival curves and Cox regression were used to assess the equality of survival curves in the three age groups before and after the intervention., Results: Net of time-varying confounders, the intervention produced a daily reduction of the risk of contagion by 4% in those aged 3-11 and 12-19 (IRR = 0·96) and by 3% in those aged 20 or more (IRR = 0·97). More importantly, there were differences in the temporal order of contagion decrease between the age groups, with the epidemic curve lowering first in the school-aged children directly affected by the intervention, and only subsequently in the adult population, which presumably indirectly benefitted from the reduction of contagion among children., Conclusion: Though it was not possible to completely discern the effect of school closures from concurrent policy measures, a substantial decrease in the contagion curves was clearly detected after the intervention. The extent to which the slowdown of infections counterbalanced the social costs of the policy remains unclear., Competing Interests: The authors have declared that no competing interests exist.

Evidence is accumulating of the negative impact of the COVID-19 pandemic and related public health measures on mental health. In this emergent field, there has been little research into the role of risk perception on depressive symptoms and the contribution of health-care resources to model risk perception and mental health. The aim of this paper is to describe the relationship between individual-level perception of risk and depression, controlling for a set of confounders and for country-level heterogeneity. A cross-sectional and observational online survey was conducted using a non-probability snowball sampling technique. We use data on 11,340 respondents, living in six European countries (Italy, Sweden, United Kingdom, France, Poland, Czech Republic) who completed survey questionnaires during the first months of the pandemic. We used a fixed-effect approach, which included individual and macro-level variables. The findings suggest that a high proportion of people suffering from depression and heightened risk perception is positively associated with reporting depressive symptoms, even if this relationship varies significantly between countries. Moreover, the association is moderated by contextual factors including health-care expenditure as a percentage of Gross Domestic Product, hospital beds for acute care, and number of medical specialists per head of population. Investment in health care offers a concrete means of protecting the mental health of a population living under pandemic restrictions., (© 2021 The Authors. Sociology of Health & Illness published by John Wiley & Sons Ltd on behalf of Foundation for SHIL (SHIL).)