Effect of the COVID-19 pandemic on mental health visits in primary care: an interrupted time series analysis from nine INTRePID countries.

Background: The COVID-19 pandemic impacted mental health disorders, affecting both individuals with pre-existing conditions and those with no prior history. However, there is limited evidence regarding the pandemic's impact on mental health visits to primary care physicians. The International Consortium of Primary Care Big Data Researchers (INTRePID) explored primary care visit trends related to mental health conditions in Argentina, Australia, Canada, China, Norway, Peru, Singapore, Sweden, and the USA. Methods: We conducted an interrupted time series analysis in nine countries to examine changes in rates of monthly mental health visits to primary care settings from January 1st, 2018, to December 31st, 2021. Sub-group analysis considered service type (in-person/virtual) and six categories of mental health conditions (anxiety/depression, bipolar/schizophrenia/other psychotic disorders, sleep disorders, dementia, ADHD/eating disorders, and substance use disorder). Findings: Mental health visit rates increased after the onset of the pandemic in most countries. In Argentina, Canada, China, Norway, Peru, and Singapore, this increase was immediate ranged from an incidence rate ratio of 1·118 [95% CI 1.053-1.187] to 2.240 [95% CI 2.057-2.439] when comparing the first month of pandemic with the pre-pandemic trend. Increases in the following months varied across countries. Anxiety/depression was the leading reason for mental health visits in most countries. Virtual visits were reported in Australia, Canada, Norway, Peru, Sweden, and the USA, accounting for up to 40% of the total mental health visits. Interpretation: Findings suggest an overall increase in mental health visits, driven largely by anxiety/depression. During the COVID-19 pandemic, many of the studied countries adopted virtual care in particular for mental health visits. Primary care plays a crucial role in addressing mental ill-health in times of crisis. Funding: Canadian Institutes of Health Research grant #173094 and the Rathlyn Foundation Primary Care EMR Research and Discovery Fund.

Safety and effectiveness of COVID-19 SPUTNIK V vaccine in dialysis patients.

INTRODUCTION: Given the vulnerability of chronic kidney disease individuals to SARS-CoV-2, nephrology societies have issued statements calling for prioritization of these patients for vaccination. It is not yet known whether COVID-19 vaccines grant the same high level of protection in patients with kidney disease compared to the non-dialysis population. The aims of this study were to evaluate the safety - measured by the adverse events potentially attributed to vaccines (ESAVI) - and the effectiveness - evaluated by the presence of antibodies - in dialysis patients immunized with the COVID-19 Sputnik V vaccine. METHODS: multicenter, observational and analytical study of a prospective cohort of hemodialysis patients from the Ciudad Autónoma de Buenos Aires participating in an official vaccination program. Dialysis requiring individuals older than 18 years, who received both components of the COVID-19 vaccine were included. RESULTS: Data from 491 patients were included in the safety analysis. ESAVI with either the first or second component was detected in 186 (37.9%, 95% CI 33.6%-42.3%). Effectiveness analysis measuring antibodies levels against SARS-CoV-2 were performed in 102 patients; 98% presented these IgG antibodies at day 21 after the second component. In patients with COVID-19 prior to vaccination, antibodies at day 21 after the first component reached almost the highest levels compared to patients without previous COVID-19, but IgG rise among patients with previous COVID-19 was lower than in those without this previous disease. CONCLUSION: The Sputnik V vaccine has been shown to be safe and effective in this patient's population.

Introducción: Dada la vulnerabilidad al SARS-CoV-2 de las personas con enfermedad renal crónica, las sociedades de nefrología han emitido declaraciones pidiendo priorizar a estos pacientes para la vacunación. Aún no se sabe si las vacunas COVID-19 confieren el mismo nivel de protección en pacientes con enfermedad renal. Los objetivos de este estudio fueron evaluar la seguridad, medida por eventos supuestamente atribuidos a las vacunas (ESAVI) y la efectividad, evaluada por la presencia de anticuerpos en pacientes en diálisis inmunizados con la vacuna COVID-19 Sputnik V. Métodos: estudio multicéntrico, observacional y analítico de una cohorte prospectiva de pacientes en hemodiálisis, en la Ciudad Autónoma de Buenos Aires, con plan de vacunación. Se incluyeron pacientes mayores de 18 años en diálisis que recibieron ambos componentes de la vacuna COVID-19. Resultados: 491 pacientes fueron incluidos en el análisis de seguridad. Se detectó ESAVI con el primer o el segundo componente en 186 (37.9% IC 95%: 33.6%-42.3%). La efectividad medida por presencia de anticuerpos IgG contra SARS-Cov-2 se realizó en 102 pacientes, 98% presentaba IgG contra SARS-CoV-2, 21 días después del segundo componente. En pacientes con COVID-19 previo a la vacunación, los anticuerpos al día 21 del primer componente alcanzaron niveles casi mayores que en aquellos que no habían sufrido COVID-19, aunque el aumento de los niveles a los 21 días del segundo componente fue menor que en los pacientes sin COVID-19 previo. Conclusión: Los pacientes en diálisis constituyen una población vulnerable para la infección por SARS-CoV-2, por lo tanto, más allá de las recomendaciones implementadas por las unidades de diálisis, la vacunación completa es mandatoria. Se ha demostrado que la vacuna Sputnik V es segura y eficaz en esta población de pacientes.

Safety and effectiveness of COVID-19 SPUTNIK V vaccine in dialysis patients / Seguridad y efectividad de vacuna COVID-19 SPUTNIK V en pacientes en diálisis

Abstract Introduction: Given the vulnerability of chronic kidney disease individuals to SARS-CoV-2, nephrology societies have issued statements calling for prioritization of these patients for vaccination. It is not yet known whether COVID-19 vaccines grant the same high level of protection in patients with kidney disease compared to the non-dialysis population. The aims of this study were to evaluate the safety - measured by the adverse events potentially attributed to vaccines (ESAVI) - and the effectiveness - evaluated by the presence of antibodies - in dialysis patients immunized with the COVID-19 Sputnik V vaccine. Methods: multicenter, ob servational and analytical study of a prospective cohort of hemodialysis patients from the Ciudad Autónoma de Buenos Aires participating in an official vaccination program. Dialysis requiring individuals older than 18 years, who received both components of the COVID-19 vaccine were included. Results: Data from 491 patients were included in the safety analysis. ESAVI with either the first or second component was detected in 186 (37.9%, 95% CI 33.6%-42.3%). Effectiveness analysis measuring antibodies levels against SARS-CoV-2 were performed in 102 patients; 98% presented these IgG antibodies at day 21 after the second component. In patients with COVID-19 prior to vaccination, antibodies at day 21 after the first component reached almost the highest levels compared to patients without previous COVID-19, but IgG rise among patients with previous COVID-19 was lower than in those without this previous disease. Conclusion: The Sputnik V vaccine has been shown to be safe and effective in this patient's population.

Resumen Introducción: Dada la vulnerabilidad al SARS-CoV-2 de las personas con enfermedad renal crónica, las sociedades de nefrología han emitido declaraciones pidiendo priorizar a estos pacientes para la vacunación. Aún no se sabe si las vacunas COVID-19 confieren el mismo nivel de protección en pacientes con enfermedad renal. Los objetivos de este estudio fueron evaluar la seguridad, medida por eventos supuestamente atribuidos a las vacunas (ESAVI) y la efectividad, evaluada por la presencia de anticuerpos en pacientes en diálisis inmuniza dos con la vacuna COVID-19 Sputnik V. Métodos: estudio multicéntrico, observacional y analítico de una cohorte prospectiva de pacientes en hemodiálisis, en la Ciudad Autónoma de Buenos Aires, con plan de vacunación. Se incluyeron pacientes mayores de 18 años en diálisis que recibieron ambos componentes de la vacuna COVID-19. Resultados: 491 pacientes fueron incluidos en el análisis de seguridad. Se detectó ESAVI con el primer o el segundo componente en 186 (37.9% IC 95%: 33.6%-42.3%). La efectividad medida por presencia de anticuerpos IgG contra SARS-Cov-2 se realizó en 102 pacientes, 98% presentaba IgG contra SARS-CoV-2, 21 días después del segundo componente. En pacientes con COVID-19 previo a la vacunación, los anticuerpos al día 21 del primer componente alcanzaron niveles casi mayores que en aquellos que no habían sufrido COVID-19, aunque el aumento de los niveles a los 21 días del segundo componente fue menor que en los pacientes sin COVID-19 previo. Conclusión: Los pacientes en diálisis constituyen una población vulnerable para la infección por SARS-CoV-2, por lo tanto, más allá de las recomendaciones implementadas por las unidades de diálisis, la vacunación completa es mandatoria. Se ha demostrado que la vacuna Sputnik V es segura y eficaz en esta población de pacientes.

Active monitoring of early safety of Sputnik V vaccine in Buenos Aires, Argentina.

This study describes the incidence of early events supposedly attributable to vaccination or immunization (ESAVI) that occurred in healthcare workers who had been inoculated with the first component of the Sputnik V vaccine. Safety at 72 h post-immunization was analyzed based on a self-reported form. Between January 5 and January 20, 2021, in Buenos Aires, Argentina, a total of 707 healthcare workers (median age 35 yrs, female 67%) were vaccinated. The response rate was 96.6% (n: 683) and 487 (71.3%) participants reported at least one ESAVI. The incidence rate was 6.3 per 1000 person/hours. The total number of ESAVIs was 1434. A total of 469 local reactions were reported, 57% of the participants reported pain at the injection site, and 11% had redness and swelling. A total of 968 systemic reactions were informed, including new or worsened muscle pain, referred by 58% of the participants, fever referred by 40%, and diarrhea referred by 5%. Five percent (n: 34) had serious adverse events and one participant had to be hospitalized. The ESAVI rate was higher in females than males (66.4% versus 51.4%; HR 1.38; 95% CI 1.13-5.38) and in workers younger than 55 yrs old (63.0% versus 28.0%; HR 2.66; 95% CI 1.32-5.38). This study demonstrates high rates of early local and systemic reactions. However, serious events were rare. Studies on long-term safety, stratified by sex and age, are needed.

Este estudio describe la incidencia de eventos supuestamente atribuibles a vacunación o inmunización (ESAVI) en trabajadores de la salud después de la inmunización con el primer componente de la vacuna Sputnik V. La seguridad a las 72 horas de la inmunización se analizó en base a un auto-reporte. Entre el 5 y el 20 de enero de 2021, en Buenos Aires, Argentina, fueron vacunados 707 trabajadores de la salud (mediana de edad 35 años, 67% mujeres). La tasa de respuesta fue 96.6% (n: 683), y 487 participantes (71.3%) informaron al menos un ESAVI. Los ESAVI totales fueron 1434 y la incidencia fue 6.3 por 1000 personas/hora. Fueron informadas 469 reacciones locales: 57% de los participantes informaron dolor en el lugar de la inyección y 11% enrojecimiento e hinchazón. Entre las 968 reacciones sistémicas, el 58% de los participantes informaron dolor muscular nuevo o empeorado, 40% fiebre y 5% diarrea. El 5% (n: 34) presentó eventos adversos graves y un paciente tuvo que ser hospitalizado. La tasa de ESAVI fue mayor entre las mujeres (66.4% versus 51.4%; HR 1.38; IC 95% 1.13-5.38) y en el grupo de trabajadores menores de 55 años (63.0 versus 28.0; HR 2.66; IC 95% 1.32-5.38). Este estudio mostró altas tasas de reacciones tempranas locales y sistémicas; sin embargo, los eventos graves fueron raros. Son necesarios estudios sobre la seguridad a largo plazo, estratificados por sexo y edad.

Active monitoring of early safety of Sputnik V vaccine in Buenos Aires, Argentina / Monitoreo activo de la seguridad temprana de la vacunación con Sputnik V en Buenos Aires, Argentina

Abstract This study describes the incidence of early events supposedly attributable to vaccination or immunization (ESAVI) that occurred in healthcare workers who had been inoculated with the first component of the Sputnik V vaccine. Safety at 72 h post-immunization was analyzed based on a self-reported form. Between January 5 and January 20, 2021, in Buenos Aires, Argentina, a total of 707 healthcare workers (median age 35 yrs, female 67%) were vaccinated. The response rate was 96.6% (n: 683) and 487 (71.3%) participants reported at least one ESAVI. The incidence rate was 6.3 per 1000 person/hours. The total number of ESAVIs was 1434. A total of 469 local reactions were reported, 57% of the participants reported pain at the injection site, and 11% had redness and swelling. A total of 968 systemic reactions were informed, including new or worsened muscle pain, referred by 58% of the participants, fever referred by 40%, and diarrhea referred by 5%. Five percent (n: 34) had serious adverse events and one participant had to be hospitalized. The ESAVI rate was higher in females than males (66.4% versus 51.4%; HR 1.38; 95% CI 1.13-5.38) and in workers younger than 55 yrs old (63.0% versus 28.0%; HR 2.66; 95% CI 1.32-5.38). This study demonstrates high rates of early local and systemic reactions. However, serious events were rare. Studies on long-term safety, stratified by sex and age, are needed.

Resumen Este estudio describe la incidencia de eventos supuestamente atribuibles a vacunación o inmunización (ESAVI) en trabajadores de la salud después de la inmunización con el primer componente de la vacuna Sputnik V. La seguridad a las 72 horas de la inmunización se analizó en base a un auto-reporte. En tre el 5 y el 20 de enero de 2021, en Buenos Aires, Argentina, fueron vacunados 707 trabajadores de la salud (mediana de edad 35 años, 67% mujeres). La tasa de respuesta fue 96.6% (n: 683), y 487 participantes (71.3%) informaron al menos un ESAVI. Los ESAVI totales fueron 1434 y la incidencia fue 6.3 por 1000 personas/hora. Fueron informadas 469 reacciones locales: 57% de los participantes informaron dolor en el lugar de la inyección y 11% enrojecimiento e hinchazón. Entre las 968 reacciones sistémicas, el 58% de los participantes informaron dolor muscular nuevo o empeorado, 40% fiebre y 5% diarrea. El 5% (n: 34) presentó eventos adversos graves y un paciente tuvo que ser hospitalizado. La tasa de ESAVI fue mayor entre las mujeres (66.4% versus 51.4%; HR 1.38; IC 95% 1.13-5.38) y en el grupo de trabajadores menores de 55 años (63.0 versus 28.0; HR 2.66; IC 95% 1.32-5.38). Este estudio mostró altas tasas de reacciones tempranas locales y sistémicas; sin embargo, los eventos graves fueron raros. Son necesarios estudios sobre la seguridad a largo plazo, estratificados por sexo y edad.

Use of alternative care sites during the COVID-19 pandemic in the city of Buenos Aires, Argentina.

OBJECTIVES: In large cities, where a large proportion of the population live in poverty and overcrowding, orders to stay home to comply with isolation requirements are difficult to fulfil. In this article, the use of alternative care sites (ACSs) for the isolation of patients with confirmed COVID-19 or persons under investigation (PUI) in the City of Buenos Aires during the first wave of COVID-19 are described. STUDY DESIGN: This is a cross-sectional study. METHODS: All patients with COVID-19 and PUI with insufficient housing resources who could not comply with orders to stay home and who were considered at low clinical risk in the initial triage were referred to refurbished hotels in the City of Buenos Aires (Ciudad Autónoma de Buenos Aires [CABA]). ACSs were divided into those for confirmed COVID-19 patients and those for PUI. RESULTS: From March to August 2020, there were 58,143 reported cases of COVID-19 (13,829 of whom lived in slums) in the CABA. For COVID-19 positive cases, 62.1% (n = 8587) of those living in slums and 21.4% (n = 9498) of those living outside the slums were housed in an ACS. In total, 31.1% (n = 18,085) of confirmed COVID-19 cases were housed in ACSs. In addition, 7728 PUI were housed (3178 from the slums) in an ACS. The average length of stay was 9.0 ± 2.5 days for patients with COVID-19 and 1.6 ± 0.7 days for PUI. For the individuals who were housed in an ACS, 1314 (5.1%) had to be hospitalised, 56 were in critical care units (0.22%) and there were 27 deaths (0.1%), none during their stay in an ACS. CONCLUSIONS: Overall, about one-third of all people with COVID-19 were referred to an ACS in the CABA. For slum dwellers, the proportion was >60%. The need for hospitalisation was low and severe clinical events were rare. This strategy reduced the pressure on hospitals so their efforts could be directed to patients with moderate-to-severe disease.