None listed
Conditions
Brief summary
People with severe mental illness (SMI) such as schizophrenia are among the groups most vulnerable for a severe course of COVID-19 illness. Factors that contribute to worse outcomes include concomitant medications, poorer premorbid general health, physical comorbidity, reduced access to medical care, and environmental and lifestyle factors such as lower socio-economic status, overcrowding, smoking, or obesity. The COVID-19 pandemic also highlighted the importance of the annual Commonwealth-funded programme of free influenza vaccination in people over the age of 65 years old and other vulnerable groups. Given that people with SMI are more likely at all ages to be eligible for the flu vaccination because of their high rate of physical comorbidity, reduced uptake will be especially clinically significant. Thus, in both COVID-19 and influenza, it is important to investigate whether vaccination has any effect on differences in subsequent COVID-19 & influenza-related morbidity and mortality between people with SMI and the general population.
Interventions
This is a cohort study where we are investigating differences in vaccination rates for COVID-19 and influenza for Australian's with and without severe mental illness (SMI). We will also investigate whether vaccination has any effect on differences in COVID-19 and influenza-related morbidity and mortality between groups.
We will identify two exposure cohorts: (i) COVID-19 exposure cohort; (ii) influenza exposure cohort. Both will be identified using Pharmaceutical Benefits Scheme (PBS) data. Me
This is a cohort study where we are investigating differences in vaccination rates for COVID-19 and influenza for Australian's with and without severe mental illness (SMI). We will also investigate whether vaccination has any effect on differences in COVID-19 and influenza-related morbidity and mortality between groups. We will identify two exposure cohorts: (i) COVID-19 exposure cohort; (ii) influenza exposure cohort. Both will be identified using Pharmaceutical Benefits Scheme (PBS) data. Members of the cohorts may overlap (i.e., individuals in the COVID-19 exposure group may also have received the influenza vaccination and vice versa). (i) COVID-19 exposure cohort: All individuals with SMI who were aged 18 years and over at 22/02/2021. We will define people as having SMI if they have been dispensed two prescriptions within 12 months for authority-only medications used specifically for SMI (ATC codes N05AH, N05AX, N05AE, N06AX) since 22/02/2019 (2 years prior to the period of interest of this study), or 2 prescriptions for lithium within 12 months. Authority-only medications will include all that were listed on the PBS during the time period (and subsequently may now be discontinued). In the case of quetiapine (ATC Code NO5AH04), we will only include anyone prescribed at least 100mg on those two occasions, to minimise the influence of off-label use. Individuals may have had the COVID-19 disease, but the cohort will not be restricted to just these individuals as we are interested in vaccination rates. (ii) Influenza exposure cohort: All individuals with SMI aged 18 years and over on 01/01/2018. We will define people as having SMI if they have been dispensed two prescriptions within 12 months for authority-only medications used specifically for SMI (ATC codes N05AH, N05AX, N05AE, N06AX) since 01/01/2016 (2 years prior to the period of interest of this study), or 2 prescriptions for lithium within 12 months. In the case of quetiapine (ATC Code NO5AH04), we will only include anyone prescribed at least 100mg on those two occasions, to minimise the influence of off-label use. Individuals may have had influenza, but the cohort will not be restricted to just these individuals as we are interested in vaccination rates. We are linking the following Commonwealth data sources: PBS, the Australian Immunisation Register (AIR), Medicare Benefits Schedule (MBS), Admitted Patient Care Database (APDC), and National Death Index (NDI). We will be using data collected between January 2016 - latest available. There is no direct participant involvement; information will only be collected through the above Commonwealth data sources.
Sponsors
NHMRC
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Eligibility for exposure cohorts: (i) COVID-19 exposure cohort: All individuals with SMI who were aged 18 years and over at 22/02/2021. We will define people as having SMI if they have been dispensed two prescriptions within 12 months for authority-only medications used specifically for SMI (ATC codes N05AH, N05AX, N05AE, N06AX) since 22/02/2019 (2 years prior to the period of interest of this study), or 2 prescriptions for lithium within 12 months. Authority-only medications will include all that were listed on the PBS during the time period (and subsequently may now be discontinued). In the case of quetiapine (ATC Code NO5AH04), we will only include anyone prescribed at least 100mg on those two occasions, to minimise the influence of off-label use. (ii) Influenza exposure cohort: All individuals with SMI aged 18 years and over on 01/01/2018. We will define people as having SMI if they have been dispensed two prescriptions within 12 months for authority-only medications used specifically for SMI (ATC codes N05AH, N05AX, N05AE, N06AX) since 01/01/2016 (2 years prior to the period of interest of this study), or 2 prescriptions for lithium within 12 months. In the case of quetiapine (ATC Code NO5AH04), we will only include anyone prescribed at least 100mg on those two occasions, to minimise the influence of off-label use. Eligibility for comparator cohorts: (i) COVID-19 comparator cohort: A random sample of people on the Medicare Consumer Directory, randomly selecting a ratio of 4 random controls to every case from the entire population aged 18 years and over at 22/02/2021. This group will consist of people who have not been dispensed a prescription for one of the specified PBS medicines (ATC codes N05AH, N05AX, N05AE, N06AX) between 22/02/2019 to latest available. (ii) Influenza comparator cohort: A random sample of people on the Medicare Consumer Directory, randomly selecting a ratio of 4 random controls to every case from the entire population aged 18 years and over on the 1st January in each of the years 2018 and 2019. This group will consist of people who have not been dispensed a prescription for one of the specified PBS medicines (ATC codes N05AH, N05AX, N05AE, N06AX) between 1/1/2016 to latest available.
Exclusion criteria
None.
Outcome results
None listed