Impact of diagnostic delay on drug utilization and use of healthcare facilities in patients with ulcerative colitis: observational study on real-world data taKen from the AdmInistRative healthcare database Of TuScany RegIon, Italy (The KAIROS-II study)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Disease epidemiology

  Drug utilisation

  Effectiveness study (incl. comparative)

  Other
• If ‘other’, further details on the scope of the study:
  Healthcare facilities utilization

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  AZATHIOPRINE

  INFLIXIMAB

  ADALIMUMAB

  GOLIMUMAB

  VEDOLIZUMAB

  TOFACITINIB

  USTEKINUMAB
• Medical condition to be studied:
  Colitis ulcerative

Population studied

• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  3500

Study design details

• Main study objective:
  This project will firstly evaluate diagnostic delay in patients with ulcerative colitis. Then, we will assess the impact of diagnostic delay on effectiveness and safety clinical outcomes by analyzing drug-utilization and healtchare facilities usage.
• Outcomes:
  Diagnostic delay (DD): potential DD in patients with ulcerative - Drug utilization and effectiveness outcomes: time free from azathioprine, treatment with advanced therapy and surgery - Safety: time free from Emergency department access or hospitalization for any cause. All the outcomes will be evaluated for both dichotomous and categorical variable 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, effectiveness and safety: Kaplan-Meier survival analysis and Hazard Ratio with corresponding 95% Confidence Interval.