Patient-level DUS analyses

Study Type/s

Patient-level DUS analyses are classified as ‘off the shelf’ studies. Patient-level DUS will offer the possibility to include population-level DUS analyses as part of the same analysis.

Study Design

New drug/s user cohort

Participants

Patient-level DUS analyses will include one or more cohort/s of incident drug users with at least 1 year of data visibility, and no use of that same drug/drug class in that previous year.

Additional eligibility criteria could apply as follows:

  • Source population could be restricted to a specific subpopulation with certain socio-demographic or clinical feature/s, e.g., people with a diagnosis of rheumatoid arthritis who then start to take a disease-modifying anti-rheumatic drug (DMARD)
  • Additional restriction/s could apply as per product label, indication, or study aim/s, e.g., people aged 18 or older at the time of therapy initiation

Follow-up

Participants will be followed up from the date of therapy initiation (index date) until the earliest of loss to follow-up, end of data availability, or death. Patients might be censored at the time they discontinue treatment or switch to an alternative therapy.

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:

  • New drug user cohort/s patient-level characteristics on or before index date
  • Indication (where available)
  • Initial dose/strength (as prescribed/dispensed at therapy initiation, where available)
  • Cumulative use within a pre-specified time period (e.g. 1 year) based on number of prescriptions and dose/strength
  • Treatment duration
  • Count of repeated prescriptions during a pre-specified time period (e.g. 1 year)

Analyses

Patient-level DUS analytics will include:

  • Large-scale characterisation of patient-level features based on code/concept and descendants, including socio-demographics, comorbidity, and previous medicine/s use any time in history, and in the year, and/or in the month previous to index date
  • Frequency and % of indication/s, based on pre-specified list of diagnoses recorded before therapy initiation (where available)
  • Reporting of minimum, p25, median, p75, and maximum initially prescribed or dispensed dose/strength (where available)
  • Reporting of minimum, p25, median, p75, and maximum cumulative use within a pre-specified time period (e.g. 1 year)
  • Reporting of minimum, p25, median, p75, and maximum treatment duration
  • Reporting of minimum, p25, median, p75, and maximum number of repeated prescriptions of the index drug during a pre-specified time period (e.g. 1 year)
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