ABSTRACT
The Italian Ethics Committees protect clinical research participants' rights and well-being guaranteeing also the scientific integrity of the research. In Italy, one of the first countries severely affected by the COVID-19 pandemic, the Ethics Committees activities have been impacted by the virus spreading and subsequent lockdown from 9 March to 16 May 2020. In mid-June 2020, a cross-sectional survey was conducted in Italy, contacting all the 90 local Ethics Committees. The survey's purpose was to analyze (1) the activities carried out by the Ethics Committees during the lockdown;(2) the features of the Ethics Committees submitted studies;and (3) the implementation of standard research evaluation protocols during the pandemic. Regions with higher incidence (HI) and lower incidence (LI) of COVID-19 were compared via the chi-square test. Out of 46 Ethics Committees that participated in the study, 258 questionnaires were obtained. A rise in the number of studies submitted to local Ethics Committees was identified in 75% of the HI, in comparison to 53% in LI regions (p < 0.001). The 15% of participants from HI areas documented a reduction in compliance with the standard research application assessment protocols. In the HI regions, a greater percentage of Ethics Committees professionals have moved to smart working in comparison with LI regions (75% vs 59%;p < 0.001). The influence of COVID-19 on Ethics Committees activities in HI territories has been considerable;the Ethics Committees workload increased dramatically especially in these areas. The smart working has been effective in ensuring the activities of Ethics Committees and the subsequent activation of clinical trials that are potentially useful for coping with the pandemic. However, it was stated that an accurate review of the submitted study documents could not be carried out, with the consequence of offering a favorable opinion on studies of not excellent nature. From the point of view of some Ethics Committee participants, the large number of studies performed in the most affected areas, together with the emergency faced during the lockdown, may have exposed Ethics Committees to the risk of reducing the implementation of ethical standards and standard assessment procedures for research applications.
ABSTRACT
Background: COVID-19 is a systemic viral disease currently spreading as a pandemic. A more severe course and prognosis of COVID-19 in systemic lupus erythematosus (SLE) and vasculitis has been reported (1). Several papers have focused on the concerns, healthcare-related behaviors and psychological impact of COVID-19 pandemic among patients with rheumatic diseases, and specifically on SLE patients, showing a trend towards remarkable psychological distress (2-4). To date, no investigation on the psychological effects of quarantine strategy on SLE patients has been carried out. Objectives: To investigate the psychological impact of the lockdown measures adopted in Italy to contrasting the COVID-19 outbreak, on patients with SLE as compared to the general population. Methods: Patients affected by SLE were given an online questionnaire focused on psychological impact and self-perception during the lockdown measures contrasting the COVID-19 outbreak. The survey was focused on COVID-19 concerns, emotional impact, self-perception and changes in daily living activities and relationships. Results were compared with those of PRESTO (imPact of quaRantine mEasures againST cOvid19) project, an Italian survey, which used the same questionnaire, directed to the general population, with or without chronic diseases. A propensity matching procedure has been applied to LEPRE (Lupus Erythematosus PRESTO project) cases and the PRESTO responders with a ratio of 2 versus 1. Results: 64 patients and 1114 unselected people completed the survey. After the matching procedure, patients were compared to 128 matched adults. Missing data were below 6%. The median age among patients was 43 years (I-III interquartile range 35-54.5), 88% were female and 100% Caucasian. The SLE subjects live mainly in detached houses (38/64 vs 348/1114, p<0.0001), having access to a private garden (52/64 vs 625/1112, p<0.0001) and also owning a pet (43/64 vs 508/1114, p<0.001), in comparison with the PRESTO sample living mainly in flats. The psychological impact measured by IES-R, GHQ.12, and CEDS scores were not statistically different between patients and the general population, such as globally COVID-19 concerns and feelings. However, patients perceived more difficulty to find some free time and enjoy it (13/60 vs 48/121, p=0.01) and to be able to solve own problems (47/61 vs 71/120, p=0.02). On the contrary, patients felt more able to cope with the problem and less sad or depressed in comparison with the PRESTO group (17/61 vs 13/120, p=0.003). Moreover, patients missed playing sports/exercise less than general population (12/63 vs 46/128, p=0.02), while they felt more the distance from family and relatives (45/63 vs 42/86, p<0.0001). Conclusion: the COVID-19 pandemic didn't unveil a greater psychological fragility of people living with SLE than the others. By contrast, a coping strategy, including the role of the family and the lifestyle, contributes to resilience of SLE in difficult scenarios such as those presented by the pandemic.