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 identification

• PURI:
  https://redirect.ema.europa.eu/resource/43706
• EU PAS number:
  EUPAS43705
• Study ID:
  43706
• Official title and acronym:
  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)
• DARWIN EU® study:
  No
• Study countries:
  Italy
• Study description:
  This project will firstly evaluate diagnostic delay (DD) in patients with ulcerative colitis (UC). Then, we will explore the impact of DD on effectiveness and safety clinical outcomes. 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 co-payment exemption code of UC from June 1st, 2011 to December 31st, 2018 (index date, ID). Patients <18 years old at ID or with look-back period <5 years or follow-up period <2 years will be excluded. DD was defined by a record of emergency department (ED) access or hospitalization for gastrointestinal causes in the 7-60 months (7-18 months: short DD, 19-60 months: long DD) preceding ID. Patients with an ED access or hospitalization for gastrointestinal causes recorded in the 6 months before the ID or with none of these records were considered timely diagnosed (TD). We performed survival analyses (Kaplan-Meier curves) for effectiveness outcomes (time free from the first: dispensation of azathioprine, advanced therapy and surgery) and safety outcomes (time free from the first: ED access and/or hospitalization for any cause) over a 2-years follow-up period. Adjusted hazard ratio (aHR) was calculated by using Cox models adjusted for age, gender and number of concomitant drugs. Both outcomes were evaluated for dichotomous (TD and DD) and categorical variables of DD (TD, short DD and long DD).
• Study status:
  Planned

Research institution and networks

Institutions

Unit of adverse drug reactions monitoring (UADRM), University Hospital of Pisa

Italy

Contact details

Marco Tuccori

Study contact

[e-mail]

Marco Tuccori

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned: 29/03/2019

Actual: 29/03/2019

Data collection

Planned: 01/10/2021

Date of final study report

Planned: 01/10/2022

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