Post-traumatic stress disorder, anxiety, depression and burnout in nursing home staff in South France during the COVID-19 pandemic.

The high mortality rate in nursing homes during the COVID-19 pandemic may be linked to psychological disorders in staff. Hence, we assessed the prevalence and associated factors of probable post-traumatic stress disorder (PTSD), anxiety, depression, and burnout of nursing home staff during the COVID-19 pandemic in a cross-sectional study including 66 randomly selected nursing homes in southern France. 537 of the contacted 3 821 nursing home workers (14.0%) responded between April and October 2021. We collected information on center organization, severity of COVID-19 exposure, and socio-demographic information in an online survey. The prevalence of probable PTSD (PCL-5), anxiety and depressive disorders (Hospital Anxiety Depression Scale) and the sub-scores of burnout syndrome (Maslach Burnout Inventory Human Services Survey for Medical Personnel) were assessed. Probable PTSD was reported in 115/537 responders (21.4% (95% CI [18.0%-24.9%])). After adjustment, low-level exposure to COVID-19 in nursing home residents (AOR, 0.5; 95% CI [0.3-0.9]), fear of managing COVID-19 residents (AOR, 3.5; 95% CI [1.9-6.4]), conflicts with residents (AOR, 2.3; 95% CI, [1.2-4.4]), conflicts with colleagues (AOR, 3.6; 95% CI [1.7-8.6]), cancellation of leave (AOR, 4.8; 95% CI [2.0-11.7]) and temporary worker employment (AOR, 3.4; 95% CI [1.7-6.9]) were associated with higher prevalence of probable PTSD. The prevalence of probable anxiety and depression were 28.8% (95% CI [24.9%-32.7%]) and 10.4% (95% CI [7.8%-13.1%]), respectively. Psychological disorders were observed in nearly one third of nursing home workers during the COVID-19 pandemic. Hence, continuous surveys and preventive measures are needed in this particularly at-risk population.

French legal approach to clinical research.

Since 1988, France has been committed to drafting laws regulating clinical research. These laws must both reflect general legal standards relating to personal data protection and patient information and comply with EU regulations, which are supra-national norms. The 2012 legislation known as "Jardé law" came into force in 2016 and distinguishes between 3 different types of research involving human subjects: category 1:interventional research implying an intervention on the patient which is not justified by their usual treatment. Category 2: interventional research, which does not focus on medicinal products and only entails minimal risks and constraints. Category 3: non-interventional research implying one or multiple acts or proceedings devoid of listed risks. These studies require preliminary favourable opinions from the French Ethical Research Committees (CPP), who are appointed by the State, and must ensure the protection of personal data. For the other types of studies (retrospective data, practice surveys), French legislation only requires that the protection of personal data is ensured. However, it is highly recommended to submit these studies to an Institutional Review Board (IRB) in order to confirm that human subjects are not involved and to obtain an ethical opinion in the event of a scientific journal submission. These laws are constantly evolving in order to comply with the various international recommendations and European regulations, which are binding in France.