Study Type/s

Population-level descriptive epidemiology are classified as ‘off the shelf’ studies.

Study Design

Population-level cohort

Participant/s

Population-level analyses will include the entire source population with at least some time (typically 1 year) of data visibility available before index date.

Additional eligibility criteria will apply as follows:

  • Analyses of disease incidence will exclude patients with a previous/prevalent history of the same disease on index date and/or in the previous (washout) year and/or in all previous history
  • The source population could be restricted to a specific subpopulation with certain socio-demographic or clinical feature/s, e.g., people aged 50+ on index date

Outcome/s

The following outcome/s will be obtained, potentially stratified by pre-specified criteria (age bands, sex, calendar year or month), and other pre-specified criteria:

  • Population-based incidence of a disease/condition (or group of diseases/conditions) on a given time point or over time (stratified by calendar period)
  • Population-based prevalence of disease (or group of diseases/conditions) on a given time point (e.g., a pre-specified date), and/or over time (e.g., stratified by month or year)

Follow-up

Follow-up will start on a pre-specified calendar time point pre-defined as index date , e.g., 1st January or 1st of a given month, and continue for a pre-specified time period, typically a week, a month or a year

Analyses

Incidence rates will have number of newly diagnosed people in the numerator, and total population (satisfying the study eligibility criteria) in the denominator. Prevalence will be calculated as number of people with the diagnosis (prevalent or new) over whole source population on a specific date (point prevalence) or over a window of time (period prevalence). Both can be stratified by socio-demographics (e.g., age bands or sex) and/or calendar period. Other criteria (e.g. disease severity/duration) may need to be considered and integrated in future studies.