Describing the Cumulative Anticholinergic Burden in Patients Over the Age of 65, With Overactive Bladder, and the Association to Healthcare Resource Utilization. A Retrospective Observational Study Using UK Electronic Medical Records (EMR) data.

Study type
Protocol
Date of Approval
Study reference ID
18_096
Lay Summary

Anticholinergic medications are the mainstay of treatment for individuals diagnosed with an overactive bladder (OAB). Patients may also be prescribed anticholinergics for a number of other conditions such as asthma and depression. Excessive use of anticholinergics can cause a number of undesirable side effects, especially in older people; the most notable of these is mental decline. Mental decline may lead to increased interactions with healthcare providers, which in turn increases costs to the healthcare system. This study seeks to understand whether increased use of anticholinergics also increases the number of visits the older OAB population make to their GP, specialists, and hospital and quantify the costs associated with this.

Technical Summary

Objective: To determine the association between cumulative anticholinergic burden, calculated using the anticholinergic cognitive burden (ACB) scale, and healthcare resource utilization (HRU) in older individuals with OAB (> 65 years).

Methods: We will identify overactive bladder (OAB) patients from the Clinical Practice Research Datalink (CPRD) GOLD database between 1st January 2006 - 31st January 2016. The mean total daily ACB score over the three-year pre-index period will be calculated and its association to HRU (GP visits, visits to specialists (psychiatrists/memory clinics, neurologists, and geriatrics), and hospitalisations) over the two-year post-index period determined through use of generalised linear models (GLM).

Analysis: Aggregated summary statistics will be provided on patient baseline characteristics. We will compare characteristics amongst ACB groups using the chi-square test, two-sample t-test or ANOVA, and mann-whitney or kruskal-wallis test respectively. The statistical model will assess the impact of cumulative mean total daily ACB on the frequency of HRU. Continuous ACB will be categorized and inputted as the predictor variable into the GLM (e.g. with Poisson, lognormal or gamma distribution since the distribution of HRU variables may be skewed).

Health Outcomes to be Measured

Number of GP consultations (surgery appointment, clinic, home visit, telephone consultation)
- Number of specialist consultations (psychiatrists/memory clinic, neurologists and geriatrics)
- Number of hospital admissions (planned visits and emergency department)

Collaborators

Margarita Landeira - Chief Investigator - Astellas Pharma Europe Ltd. - UK
Ashley Jaggi - Corresponding Applicant - Astellas Pharmaceuticals
Celine Quelen - Collaborator - Creativ-Ceutical ( do not use )
Francis Fatoye - Collaborator - Manchester Metropolitan University
Laurie Cooper - Collaborator - Manchester Metropolitan University
Ramzi Argoubi - Collaborator - Creativ-Ceutical ( do not use )
Sameh Ferchichi - Collaborator - Creativ-Ceutical ( do not use )
Vasileios Giagos - Collaborator - Manchester Metropolitan University
Xinyi Tu - Collaborator - Creativ-Ceutical ( do not use )

Former Collaborators

Jameel Nazir - Chief Investigator - Astellas Pharmaceuticals

Linkages

HES Admitted Patient Care;HES Outpatient;Patient Level Townsend Score;Practice Level Index of Multiple Deprivation