5-ASA in Crohn's Disease: The CROHN'S Investigation (Clinical and treatment Resource use, patient Outcomes and Health impact using National prescribing Systems)

Study type
Protocol
Date of Approval
Study reference ID
18_065
Lay Summary

5-aminosalicylic acid (5-ASA) is a widely used treatment for mild Crohn's disease (a type of inflammatory bowel disease [IBD]), which is a long term condition that causes inflammation of the intestines. There is debate among IBD specialists, however, about how effective 5-ASA treatment really is and what types of patients most benefit from its use. We propose to study the routinely collected data on the use of 5-ASA in patients with Crohn's disease from the Clinical Practice Research Datalink (CPRD). During this process, we will select Crohn's disease patients being treated with a 5-ASA to assess how long they have been on the medicine, how they are performing on the medicine, and their use of healthcare resources/services (e.g. general practitioner visits, visits to the hospital, additional medication to help manage their condition etc.). This study will provide new insights into how 5-ASA are used in routine practice and what benefits patients experience in terms of control of their disease.

Technical Summary

This is an observational, retrospective, database investigation to identify and assess pharmaceutical prescribing patterns, healthcare resource utilisation, management practices, patient types, and patient outcomes for adult patients (more than or equal to 18 years) diagnosed with Crohn's disease (CD) treated with 5-aminosalicylic acid (5-ASA). Data will be collected from anonymised records over a period from 2006 to the present day (date the data are extracted from the database). The following key areas will be investigated: 1) Continuation rates for use of 5-ASAs in patients with CD (including: baseline and subsequent treatment patterns; continuation rates at 1 year, 2 years, 5 years, and 10 years; treatment switch/change; add-on treatment, including corticosteroids; and dose optimisation of treatment); and, 2) Resource utilisation of patients treated with 5-ASAs (including: visits to primary care [total and CD-related, if available] and specialist consultant [for CD]; hospitalisations; surgery; diagnostic and monitoring procedures, e.g. endoscopy, ultrasound, biopsy, etc.; laboratory tests, e.g. blood, stool, etc.; and drug costs).

Health Outcomes to be Measured

Continuation rates on 5-ASA, e.g. 1, 2, 3, 5, 10 years
Treatment/prescribing patterns of 5-ASA in primary care, e.g. treatment Resource utilisation, e.g. primary care visits, hospitalisations, surgery, diagnostic and monitoring procedures, laboratory tests, drug costs
Patient reported outcomes (if available)

Collaborators

John Fullarton - Chief Investigator - Strategen
Barry Rodgers-Gray - Corresponding Applicant - Strategen
James Edwards - Collaborator - Strategen
John Watkins - Collaborator - UWCM - University of Wales College of Medicine
Scot Buchan - Collaborator - Strategen

Linkages

HES Admitted Patient Care;HES Diagnostic Imaging Dataset;HES Outpatient