Clinical and economic burden of illness of catheter users in the UK

Date of Approval
Application Number
21_000312
Technical Summary

The aim of this study is to characterise the clinical and economic burden associated with chronic intermittent catheterisation, as well as the burden experienced by patients using different bladder management solutions amongst key clinical subgroups (patients with multiple sclerosis [MS] and with spinal cord injury [SCI]). The study will be carried out using a retrospective cohort design and use data from the 1st of January 2011 to the 31st of December 2020. Data on patient care records will be taken from the CPRD; secondary care data relevant to catheter use will be taken from the Hospital Episode Statistics database for patients in England. In the primary analysis, chronic intermittent urinary catheter users, defined as patients with ≥3 records of a relevant product code, with consecutive relevant records recorded within ≤4 months of each other, and who have been using catheters ≥6 months, will be compared to a cohort of non-catheterising patients matched 1:5 on age and gender. Start of follow-up will be the date of index intermittent catheterisation; patients will be followed until an interruption of catheter use or censoring from the dataset (end of CPRD follow-up or death). The secondary analyses will compare users of different bladder management solution (intermittent catheters, indwelling catheters, no catheters) amongst patients with MS or SCI, and non-catheterising patients from the general CPRD population matched 1:5 on age and sex. The demographic characteristics of the exposed and unexposed cohorts included in the primary and each of the secondary analyses will be summarised. Outcomes include clinical conditions and the costs associated with relevant healthcare utilisation and medication use. For statistical testing between groups, the Chi-squared or Mann-Whitney Wilcox tests will be used for categorical and continuous variables, respectively, with an alpha of 0.05.

Health Outcomes to be Measured

Outcomes to be measured
Primary Outcomes

Product Use

• Type of catheter used (indwelling vs intermittent); cost associated with catheter use; number of catheters used per day; type of other continence product used; total cost associated with other continence product use; number of other continence products used per day

Prevalence and Incidence of Comorbidities

• Overall prevalence of comorbidity events; prevalence of specific comorbidities (diabetes; dehydration; mental health disorders; sexual dysfunction; overall UTIs; upper UTI; lower UTI; UTI, site not specified; infection in the prostate or testicles; pyelonephritis; all sepsis; possible uro-sepsis; kidney disease; calculus of urinary tract; urinary obstruction and urinary strictures; cancer in bladder or urethra; bowel disease; urinary incontinence; retention; resistance to antibiotics; autonomic dysreflexia; haematuria; mechanical complication of urinary [indwelling] catheter; infection and inflammatory reaction due to prosthetic device, implant and graft in urinary system)
• Overall incidence of comorbidity events; incidence of specific comorbidities (dehydration; mental health disorders; overall UTIs; upper UTI, lower UTI; UTI, site not specified; infection in the prostate or testicles; pyelonephritis; all sepsis; possible uro-sepsis; calculus of urinary tract; resistance to antibiotics; autonomic dysreflexia; haematuria; mechanical complication of urinary [indwelling] catheter; infection and inflammatory reaction due to prosthetic device, implant and graft in urinary system)

Costs and Resource Use Associated with Comorbidities

• GP visits for UTIs; admissions for UTIs (as a primary diagnosis); admissions with UTIs (as a secondary diagnosis); non-elective admission for UTIs; elective admissions for UTIs; readmissions for UTIs and dehydration
• Length of stay for comorbidities (dehydration; UTIs; all sepsis; possible uro-sepsis; kidney disease; resistance to antibiotics)
• Overall cost associated with comorbidities; cost associated with specific comorbidities (dehydration; overall UTIs; upper UTI; lower UTI; UTI, site not specified; infection in the prostate or testicles; pyelonephritis; all sepsis; possible uro-sepsis; kidney disease; autonomic dysreflexia)

Medication Use

• Prevalence of use of the following medications: antibiotics; antibiotic use possibly used to treat a UTI; medication for mental health; medication urinary frequency and incontinence; laxative and other bowel-related medication; MS-related medication; pain killers; prophylactic antibiotics
• Incidence use of the following medications: antibiotics; antibiotics possibly used to treat a UTI; pain killers
• Costs associated with antibiotic use; costs associated with antibiotics possibly used to treat a UTI

Overall Healthcare Utilisation

Total cost; total health care utilisation; average length of stay when hospitalised; average number of hospitalisations; average number of emergency visits; average number of GP visits; average cost of hospitalisation; average cost of emergency visit; average cost of GP visit; average outpatient medication costs; hospital death rate

Top Ranked Reason for Healthcare Utilisation

Top 20 reasons for hospital admissions; emergency room visits; readmissions GP visits; specialist consultant (urologist) visits; top 20 primary diagnoses of patients who died in hospital

Secondary Outcomes

Age; gender; ethnicity; patient-level and practice-level deprivation score

Collaborators

Audrey Artignan - Chief Investigator - Costello Medical Consulting Ltd
Audrey Artignan - Corresponding Applicant - Costello Medical Consulting Ltd
Amy Buchanan-Hughes - Collaborator - Costello Medical Inc.
Fiona Mthombeni - Collaborator - Coloplast
Gareth Jones - Collaborator - Central Manchester University Hospitals
Harriet Cant - Collaborator - Costello Medical Consulting Ltd
Iro Chatzidaki - Collaborator - Costello Medical Consulting Ltd
Jalesh Panicker - Collaborator - National Hospital for Neurology and Neurosurgery
Jennifer Page - Collaborator - Costello Medical Consulting Ltd
Jonathan Pearson-Stuttard - Collaborator - Imperial College London
Marie Lynge Buchter - Collaborator - Coloplast
Rachel Ainsworth - Collaborator - Coloplast
Tatjana Marks - Collaborator - Costello Medical Consulting Ltd

Linkages

HES Accident and Emergency;HES Admitted Patient Care;HES Outpatient;Patient Level Index of Multiple Deprivation;Practice Level Index of Multiple Deprivation