Effectiveness and Medicoeconomic Evaluation of Home Monitoring of Patients With Mild COVID-19: Covidom Cohort Study.

BACKGROUND: Covidom was a telemonitoring solution for home monitoring of patients with mild to moderate COVID-19, deployed in March 2020 in the Greater Paris area in France to alleviate the burden on the health care system. The Covidom solution included a free mobile application with daily monitoring questionnaires and a regional control center to quickly handle patient alerts, including dispatching emergency medical services when necessary. OBJECTIVE: This study aimed to provide an overall evaluation of the Covidom solution 18 months after its inception in terms of effectiveness, safety, and cost. METHODS: Our primary outcome was to measure effectiveness using the number of handled alerts, response escalation, and patient-reported medical contacts outside of Covidom. Then, we analyzed the safety of Covidom by assessing its ability to detect clinical worsening, defined as hospitalization or death, and the number of patients with clinical worsening without any preceding alert. We evaluated the cost of Covidom and compared the cost of hospitalization for Covidom and non-Covidom patients with mild COVID-19 cases seen in the emergency departments of the largest network of hospitals in the Greater Paris area (Assistance Publique-Hôpitaux de Paris). Finally, we reported on user satisfaction. RESULTS: Of the 60,073 patients monitored by Covidom, the regional control center handled 285,496 alerts and dispatched emergency medical services 518 times. Of the 13,204 respondents who responded to either of the follow-up questionnaires, 65.8% (n=8690) reported having sought medical care outside the Covidom solution during their monitoring period. Of the 947 patients who experienced clinical worsening while adhering to daily monitoring, only 35 (3.7%) did not previously trigger alerts (35 were hospitalized, including 1 who died). The average cost of Covidom was €54 (US $1=€0.8614) per patient, and the cost of hospitalization for COVID-19 worsening was significantly lower in Covidom than in non-Covidom patients with mild COVID-19 cases seen in the emergency departments of Assistance Publique-Hôpitaux de Paris. The patients who responded to the satisfaction questionnaire had a median rating of 9 (out of 10) for the likelihood of recommending Covidom. CONCLUSIONS: Covidom may have contributed to alleviating the pressure on the health care system in the initial months of the pandemic, although its impact was lower than anticipated, with a substantial number of patients having consulted outside of Covidom. Covidom seems to be safe for home monitoring of patients with mild to moderate COVID-19.

Association between mental disorders and COVID-19 outcomes among inpatients in France: A retrospective nationwide population-based study.

BACKGROUND: Mental disorders are at-risk of severe COVID-19 outcomes. There is limited and heterogeneous national data in hospital settings evaluating the risks associated with any pre-existing mental disorder, and susceptible subgroups. Our study aimed to investigate the association between pre-existing psychiatric disorders and outcomes of adults hospitalised for COVID-19. METHOD: We used data obtained from the French national hospital database linked to the state-level psychiatric registry. The primary outcome was 30-days in-hospital mortality. Secondary outcomes were to compare the length of hospital stay, Intensive Care Unit (ICU) admission and ICU length. Propensity score matching analysis was used to control for COVID-19 confounding factors between patients with or without mental disorder and stratified by psychiatric subgroups. RESULTS: Among 97 302 adults hospitalised for COVID-19 from March to September 2020, 10 083 (10.3%) had a pre-existing mental disorder, mainly dementia (3581 [35.5%]), mood disorders (1298 [12.9%]), anxiety disorders (995 [9.9%]), psychoactive substance use disorders (960 [9.5%]), and psychotic disorders (866 [8.6%]). In propensity-matched analysis, 30-days in-hospital mortality was increased among those with at least one pre-existing mental disorder (hazard ratio (HR) 1.15, 95% CI 1.08-1.23), psychotic disorder (1.90, 1.24-2.90), and psychoactive substance disorders (1.53, 1.10-2.14). The odds of ICU admission were consistently decreased for patients with any pre-existing mental disorder (OR 0.83, 95% CI 0.76-0.92) and for those with dementia (0.64, 0.53-0.76). CONCLUSION: Pre-existing mental disorders were independently associated with in-hospital mortality. These findings underscore the important need for adequate care and targeted interventions for at-risk individuals with severe mental illness.

Brand-specific influenza vaccine effectiveness estimates during 2019/20 season in Europe - Results from the DRIVE EU study platform.

DRIVE (Development of Robust and Innovative Vaccine Effectiveness) is an IMI funded public-private platform that aims to annually estimate brand-specific influenza vaccine effectiveness (IVE), for public health and regulatory purposes. IVE analyses and reporting are conducted by public partners in the consortium. In 2019/20, four primary care-based test-negative design (TND) studies (Austria, England, Italy (n = 2)), eight hospital-based TND studies (Finland, France, Italy, Romania, Spain (n = 4)), and one population-based cohort study (Finland) were conducted. The COVID-19 pandemic affected influenza surveillance in all participating study sites, therefore the study period was truncated on February 29, 2020. Age-stratified (6 m-17y, 18-64y, ≥65y), confounder-adjusted, site-specific adjusted IVE estimates were calculated and pooled through meta-analysis. Parsimonious confounder-adjustment was performed, adjusting the estimates for age, sex and calendar time. TND studies included 3531 cases (351 vaccinated) and 5546 controls (1415 vaccinated) of all ages. IVE estimates were available for 8/11 brands marketed in Europe in 2019. Most children and adults < 64y were captured in primary care setting and the most frequently observed vaccine brand was Vaxigrip Tetra. The estimate against any influenza for Vaxigrip Tetra in primary care setting was 61% (95%CI 38-77) in children and 32% (95%CI -13-59) in adults up to 64y. Most adults ≥ 65y were captured in hospital setting and the most frequently observed brand was Fluad, with an estimate of 52% (95%CI 27-68). The population-based cohort covered 511,854 person-years and two vaccine brands. In children aged 2-6y, the IVE against any influenza was 68% (95%CI 58-75) for Fluenz Tetra and 71% (56-80) for Vaxigrip Tetra. In adults ≥ 65y, IVE against any influenza was 29% (20-36) for Vaxigrip Tetra. DRIVE is a growing platform. Public health institutes with surveillance data and hospitals in countries with high influenza vaccine coverage are encouraged to join DRIVE.

Challenges and Adaptation of a European Influenza Vaccine Effectiveness Study Platform in Response to the COVID-19 Emergence: Experience from the DRIVE Project.

The Development of Robust and Innovative Vaccine Effectiveness (DRIVE) project is a public-private partnership aiming to build capacity in Europe for yearly estimation of brand-specific influenza vaccine effectiveness (IVE). DRIVE is a five-year project funded by IMI (Innovative Medicines Initiative). It was initiated as a response to the guidance on influenza vaccines by EMA (European Medicines Agency), which advised vaccine manufacturers to work with public health institutes to set up a joint IVE study platform. The COVID-19 pandemic reached Europe in February 2020 and overlapped with the 2019/2020 influenza season only in the last weeks. However, several elements of the DRIVE study network were impacted. The pandemic specifically affected the study sites' routines and the subsequent assessment of the 2019/20 influenza season. Moreover, the current social distancing measures and lockdown policies across Europe are expected to also limit the circulation of influenza for the 2020/21 season, and therefore the impact of COVID-19 will be higher than in the season 2019/20. Consequently, DRIVE has planned to adapt its study platform to the COVID-19 challenge, encompassing several COVID-19 particularities in the study procedures, data collection and IVE analysis for the 2020/21 season. DRIVE will study the feasibility of implementing these COVID-19 components and establish the foundations of future COVID-19 vaccine effectiveness studies.