Variations in the management of Inflammatory Bowel Disease over time: How has Covid-19 effected inflammatory bowel disease patients?

Study type
Protocol
Date of Approval
Study reference ID
22_001723
Lay Summary

Inflammatory bowel disease (IBD) is umbrella term for Ulcerative Colitis and Crohn’s disease, conditions characterised by inflammation of the bowel that follow a relapsing and remitting course of varying severity. IBD may be managed with medications in the outpatient setting but occasionally require hospital admission for stronger medications or emergency surgery. Emergency surgery has a higher risk of complications compared to planned surgery. If planned surgery were to be delayed, their condition might deteriorate to such that they require emergency surgery with the associated worse outcomes.

Over the last twenty years, the management of IBD has changed significantly with the widespread use of powerful medications that reduce the activity of the immune system, reconfiguration of services and minimally invasive “key hole” surgery. It is likely the cumulative effect of these changes has improved rates of emergency surgery and associated complications.

The Covid-19 pandemic led to an immediate change in the way healthcare could be delivered, resulting in minimal access to ‘non-cancer’ care. It is well established that those from socioeconomically disadvantaged backgrounds are less likely to access healthcare, particularly in times of resource scarcity. Furthermore there is likely to be regional variation in response to the pandemic. Understanding how this has affected IBD patients will help to guide recovery strategies and develop robust treatment pathways ensuring IBD patients are not disadvantaged in the recovery phase from the pandemic. We hope that it will provide evidence to support IBD patients need to be prioritised in a similar way to cancer patients.

Technical Summary

Inflammatory bowel disease (IBD) is a chronic, relapsing and remitting condition associated with significant morbidity and reduction in quality of life. IBD management has changed significantly in the last two decades. The increased use of biological therapies and widespread uptake of minimally invasive surgery has revolutionised medical and surgical management of IBD patients. These changes are likely to have influenced the number of patients requiring emergency surgery and its associated morbidity and mortality.

There is evidence suggesting socioeconomic status and where patients are treated may be associated with variations in both the treatment received by patients and their outcomes. The Covid-19 pandemic led to an overhaul in service delivery but the reconfiguration of services varied significantly from region to region. The effect of the above, particularly during the pandemic period on IBD patients is unknown.

Objectives:
To establish if emergency admissions and surgery for IBD patients has changed over time due to advances in medical and surgical practice.
To establish how elective surgery delivery has changed over time and how this has been affected by the pandemic.
To investigate if socioeconomic status and geographic region effects the treatment and outcomes of IBD patients.

Design:
This will be a retrospective open cohort study of patients who have a known diagnosis of IBD between 2000 and 2021. Patients will be identified using Medcodes for IBD from CPRD and ICD 10 codes from HES data. Surgery will be defined by the OPCS codes from the linked HES data and socioeconomic status from CPRD linked small area data . Mortality will be defined from the Office of National Statistics data.

We will calculate rates of surgery over time using an interrupted time analysis and model them with Poisson regression. We will calculate crude mortality rates and build appropriate Cox proportional hazards regression models.

Health Outcomes to be Measured

• Rates of emergency compared to elective surgery over time.
• Differences in adverse outcomes for IBD patients requiring emergency rather than elective surgery. Adverse outcomes will include mortality, length of stay, stoma rates and post operative complications including 30 day re-operation rates.
• The affect of the Covid-19 pandemic on elective and emergency surgery rates.
• Effect of medical treatment on elective and emergency colectomy rates over time.
• Effect of socioeconomic status on adverse outcomes and access to treatment.
• Variation in practice and outcomes between geographic regions.

Collaborators

David Humes - Chief Investigator - University of Nottingham
Jennifer Couch - Corresponding Applicant - University of Nottingham
Timothy Card - Collaborator - University of Nottingham
Yue Huang - Collaborator - University of Nottingham

Linkages

HES Admitted Patient Care;ONS Death Registration Data;Patient Level Index of Multiple Deprivation;Practice Level Index of Multiple Deprivation