Diagnostic delay, drug utilization and clinical effectiveness and safety outcomes in patients with Crohn’s disease: checKing and AssessIng Real wOrld data from healthcare adminiStrative databases in Tuscany, Italy. The KAIROS study (the KAIROS study)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology

  Drug utilisation

  Effectiveness study (incl. comparative)

  Safety study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  BUDESONIDE
• Medical condition to be studied:
  Crohn's disease

Population studied

• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)
• Estimated number of subjects:
  3000

Study design details

• Main study objective:
  This project will evaluate diagnostic delay in patients with Crohn's disease. Then, drug utilization, adherence of standard treatment (budesonide) and efficacy and safety clinical outcomes will be evaluating by exploring their relationship with diagnostic delay.
• Outcomes:
  - Diagnostic delay (DD): potential DD in patients with Crohn’s disease - Drug utilization: patterns of utilization of budesonide in patients with Crohn’s disease for variables of DD - Effectiveness: clinical effectiveness outcomes of patients with Crohn’s disease for variables of DD - Safety: clinical effectiveness outcomes of patients with Crohn’s disease for variables of DD
• Data analysis plan:
  Diagnostic delay: We will tabulate the distribution of dichotomous and categorical variables of interest in the study population. We will compute Chi-squared test at significance level α = 0.05 to assess if there is difference between categories in dichotomous and categorical variables. Drug-utilization: trajectory model approach. Effectiveness and safety: Kaplan-Meier survival analysis and Hazard Ratio with corresponding 95% Confidence Interval.