Patient-level characterisation

Study Type/s

Patient-level characterisations are classified as ‘off the shelf’ 

Study Design

Cohort analysis.

Participant/s

Patient-level characterisation studies will include one or more cohort/s of people newly diagnosed with 1 or more pre-specified condition/s and with some amount of data visibility before diagnosis, and with no record of the same condition/s in the previous year (or in all previous history).

Additional eligibility criteria could apply as follows, to be incorporated as sensitivity analyses:

  • Additional restriction/s could apply based on socio-demographics, e.g., people aged 18 or older at the time of diagnosis
  • Additionally, people with a competing (differential) diagnosis could also be excluded (e.g., people with rheumatoid arthritis with a history of psoriatic arthritis could be excluded to minimise misclassification)

Follow-up

Participants will be followed up from their date of new diagnosis (index date) until the earliest of the following: loss to follow-up, end of data availability, a pre-specified time period (e.g. 1 year after index date) or death.

Analyses

Details will be discussed during programming of pipelines, but it is likely that patient-level characterisation will include:

  • Automated large-scale characterisation, including all recorded baseline characteristics available in the data before or on index date, based on code/s, and classified into conditions (medical history), medicine/s use, and procedure/s
  • Pre-specified patient-level characteristics on and/or before index date, based on pre-existing code lists or definitions (e.g., history of type 2 diabetes, or Charlson comorbidity index)
  • Pre-specified patient-level characteristics on and/or before index date, based on concepts and descendants where no previously validated algorithms are available
  • Incidence rate/s of pre-specified outcome/s within a pre-specified time period (e.g. 1 year)
  • Prognosis / progression to a pre-specified outcome within a pre-specified time, e.g., cumulative incidence of certain events or mortality within 1- or 5-years after diagnosis
  • Standard care description, including n (%) receiving each of a pre-specified list of medicine/s, device/s or procedure/s, and combinations within a pre-specified time window after diagnosis
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