Status: Planned First registered on: 18/12/2020
Last updated on: 18/12/2020
1. Study identification
EU PAS Register NumberEUPAS38705
Official titleDiagnostic 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
Study title acronymthe KAIROS study
Study typeObservational study
Brief description of the studyThis 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.
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)? Not applicable
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsUADRM
Department/Research groupUnit of adverse drug reactions monitoring
Organisation/affiliationUniversity hospital of Pisa
Website/Homepagehttp://www.ao-pisa.toscana.it/index.php?option=com_content&view=article&id=2256%3Asez-dip-monitoraggio-reazioni-avverse-ai-farmaci&catid=383&Itemid=54; http://www.medmcs.unipi.it/laboratorio-pharmacovigilance-and-drug-safety.html
Details of (Primary) lead investigator
Title Dr
Last name Tuccori
First name Marco
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Not applicable (single centre)

Countries in which this study is being conducted
National study

Italy
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed29/03/201929/03/2019
Start date of data collection01/01/2021
Start date of data analysis
Date of interim report, if expected
Date of final study report31/12/2021
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companies
Charities
Government body
Research councils
EU funding scheme
OtherPisa University Hospital100
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Tuccori
First name Marco
Address line 1via Roma 55
Address line 2 
Address line 3 
CityPisa 
Postcode56126 
CountryItaly
Phone number (incl. country code)39-050-2218761 
Alternative phone number 
Fax number (incl. country code) 
Email address marco.tuccori@gmail.com
Public Enquiries
Title Dr 
Last name Tuccori 
First name Marco 
Address line 1via Roma 55 
Address line 2 
Address line 3 
CityPisa 
Postcode56126 
CountryItaly 
Phone number (incl. country code)39-050-2218761 
Alternative phone number 
Fax number (incl. country code) 
Email address marco.tuccori@gmail.com 
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