Stomas are connections formed through surgery between a tube-like structure in the body and the skin. The stoma redirects flow of food, stool, urine or other substances from their usual route and directs them outside the body. A colostomy is a stoma originating from the large intestine. An ileostomy is a stoma originating from the latter segment of the small intestine. A urostomy is a stoma originating from the urinary tract.
There are may reasons for a stoma to be formed. The usual reasons are related to problems in the downstream flow of digestive products or urine, such as blockage from growths or tumours, inflammation, or malformations from birth.
Because flow is redirected through an unusual route, complications may result. These complications may include infections, mental health issues, and skin problems. Many of those complications require attention by healthcare professionals, resulting in appointments with the GP, or even admissions in hospitals. These interactions with the National Health Service (NHS) result in costs incurred by the health system in England.
This study would like to quantify the complications and costs that colostomies, ileostomies and urostomies pose to the NHS in England in primary and secondary care.
We would like to compare these costs and complications with other patients who do not have stomas. This way, we will be able to determine what additional costs and complications patients with stomas have, compared to the general patient population. Ultimately, these findings may influence policies surrounding the care, and payment of care, of patients with stomas.
Colostomies, ileostomies and urostomies are interventions meant to alleviate the symptom and disease burden of conditions that affect the gastrointestinal and urinary tracts. By redirecting the flow of digestive products or urine cutaneously, the downstream tracts are allowed to undergo treatment, excision or recovery. However, the stomas formed in these interventions may have an increased tendency towards infection and skin disruption. Having a stoma itself may cause psychological and mental health issues. These complications, in turn, result in costs to the NHS in England, in both primary and secondary care.
This retrospective cohort study seeks to determine the incremental health system burden and costs of these 3 types of stomas in primary and secondary care in England, compared to an age- and sex- matched population of patients without stomas.
Three general cohorts shall be created using read codes in primary care to identify patients with a 1) colostomy, 2) ileostomy, and 3) urostomy. Their comparison control groups shall be created using age- and sex-matching in a 1:50 proportion.
Once the cohorts and their counterpart control groups are identified, their primary and secondary care records shall be retrieved. Data on patient demographics, clinical outcomes, and healthcare resource use outcomes shall be extracted. The primary outcome would be the total annual cost of inpatient, outpatient, A&E and GP care. Costs will be computed utilising BNF prices, HRG tariffs, and PSSRU prices multiplied by the volume of resources consumed. Comparisons between each cohort and their counterpart control group shall be made on the outcomes specified, using either odds ratios or mean differences where applicable, with 95% confidence intervals and p-values reported. Student's unpaired t-test shall be used for comparisons of the means of two groups. Fisher's test or the chi-square test shall be performed to compare proportions in two groups.
With these comparisons, the researchers hope to quantify the incremental costs and complication burden that colostomies, ileostomies and urostomies pose to the English NHS.
Patient Demographics (total patients, age, sex, ethnicity, time from stoma creation, Charlson Comorbidity Index, time in cohort, follow-up duration); Clinical Outcomes (all-cause mortality, inpatient mortality, skin complications, psychological and behavioural complications, parastomal hernia and stomal prolapse, urinary tract infections, sepsis, revision of stoma); Healthcare Resource Use Outcomes (inpatient admissions, procedures, specialties, and costs; outpatient admissions, procedures, specialties, and costs; accident & emergency attendances, procedures and costs; GP attendances, nursing interactions, prescriptions, medications, and referrals)
Adrian Paul J. Rabe - Chief Investigator - Health iQ Ltd ( UK ) t/a CorEvitas
Adrian Paul J. Rabe - Corresponding Applicant - Health iQ Ltd ( UK ) t/a CorEvitas
Hassan Chaudhury - Collaborator - Health iQ Ltd ( UK ) t/a CorEvitas
Austen El-Osta - Collaborator - Imperial College London
Liam Poynter - Collaborator - Imperial College London
HES Accident and Emergency;HES Admitted Patient Care;HES Outpatient;ONS Death Registration Data