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 identification

• PURI:
  https://redirect.ema.europa.eu/resource/38706
• EU PAS number:
  EUPAS38705
• Study ID:
  38706
• Official title and acronym:
  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)
• DARWIN EU® study:
  No
• Study countries:
  Italy
• Study description:
  This project will firstly 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. We will perform a retrospective cohort study. Data will be retrieved from the administrative healthcare databases of Tuscany, an Italian region. Patients will be included if they have a first record of ICD-9 diagnosis or disease exemption or a first record of dispensation of oral budesonide as CD patient from 6/1/2011 to 6/30/2016 (index date, ID). Patients <18 years old at ID or with look-back period <5 years or follow-up period <3 years will be excluded. Patients will be classified with DD if they have at least one access to emergency department (ED) or hospitalization for gastro-intestinal (GI) causes earlier than 6 months before ID, during the look-back period. A sub-group of patients will be selected for the drug-utilization analysis. Trajectories of adherence to drug treatment were computed with a three-step procedure for drug-utilization analysis: 1) computation of 24 statistical measures, 2) factor analysis, 3) cluster analysis. Clusters of patients will be described with a focus on DD occurrence. Clinical effectiveness and safety outcomes will be investigated through survival analyses and Hazard Ratio and corresponding 95% Confidence Interval will be estimated.
• Study status:
  Planned

Research institutions and networks

Institutions

University Hospital of Pisa

Study timelines

Date when funding contract was signed

Planned: 29/03/2019

Actual: 29/03/2019

Study start date

Planned: 01/01/2021

Date of final study report

Planned: 31/12/2021

Sources of funding

Other

More details on funding

Pisa University Hospital

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable