Ulcerative colitis is a chronic condition, where the colon and rectum become inflamed. Symptoms typically include recurring diarrhoea, abdominal pain, needing to empty bowels frequently, extreme tiredness, loss of appetite and weight loss. It is estimated that around 146,000 people in the UK have a diagnosis of ulcerative colitis.
The treatments for ulcerative colitis aim to relieve symptoms during flares (periods where symptoms are particularly bothersome) and to prevent symptoms from returning. This is achieved in many patients using medications such as aminosalicylates, corticosteroids or immunosuppressants, and if required, biologic therapies. If these medications aren't effective at controlling symptoms, surgery to remove the colon and/or rectum may be an option. However, patients who undergo surgery do not necessarily achieve relief from symptoms and experience general complications, which may still compromise their daily living.
To better understand the consequences of undergoing surgery and what types of patients require surgery, this study in patients with ulcerative colitis who undergo surgery will compare baseline characteristics, and the resources and cost required to treat/manage patients prior to and after surgery. Results of this study may indicate that surgery is not the best option for these patients and instead further advanced medications are required.
Objectives: The primary objective is to estimate the pre- and post-operative healthcare resource utilisation (HCRU) and direct healthcare costs among patients with ulcerative colitis (UC) undergoing a colectomy.
Methods: This study will be a retrospective, longitudinal cohort study of ulcerative colitis patients undergoing a colectomy between Jan 2011 and Dec 2015, inclusive. The cohort of patients will be identified from the Clinical Practice Research Datalink and Hospital Episode Statistics (Admitted Patient Care and Outpatient data sets). Then index event will be defined using Office of Population Censuses and Surveys Classification of Surgical Operations and Procedures (4th revision) codes. Elements of HCRU that will be considered in this study include General Practitioner consultations, medicines prescribed in primary care (aminosalicylates, corticosteroids and immunosuppressants), outpatient appointments and inpatient stays (including additional surgeries, length of stay, high-cost drug use).
Data analysis: The study will be predominantly descriptive in nature, with elements of comparative analysis between patients undergoing an elective colectomy versus an emergent colectomy. In addition, generalised linear models will be constructed to assess potential predictors of high post-operative HCRU and/or costs, type of colectomy required and post-operative complications experienced.
All-cause GP appointments; All-cause hospitalisations; All-cause outpatient appoints; All-cause emergency admissions; Primary care prescriptions of steroids, immunosuppressants and aminosalicylates; Post-operative complications in secondary care; Associated direct healthcare costs
Danielle Bargo - Chief Investigator - Pfizer Inc - US Headquarters
Robert Wood - Corresponding Applicant - Adelphi Real World
- Collaborator -
John Waller - Collaborator - Adelphi Real World
Joseph Cappelleri - Collaborator - Pfizer Inc - US Headquarters
Leonardo Salese - Collaborator - Pfizer Inc - US Headquarters
Marco DiBonaventura - Collaborator - Pfizer Inc - US Headquarters
Natalie Bohm - Collaborator - Pfizer Ltd - UK
Olivia Massey - Collaborator - Adelphi Real World
Ruth Mokgokong - Collaborator - Pfizer Ltd - UK
Danielle Bargo - Chief Investigator - Pfizer Inc - US Headquarters
HES Admitted Patient Care;HES Outpatient