A Study on Anticholinergic Use: Attribution of Overactive Bladder (OAB) Medications to the Anticholinergic Burden

Study Overview
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Brief Summary
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Outpatients with at least one dispensing record of any medication will be included in the study. An index date will be assigned to each participant and prescription records for anticholinergics will be used in the study.

Official Title
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A Retrospective Database Analysis of Anticholinergic Burden Among the Elderly With and Without Overactive Bladder in Australia and South Korea

Conditions
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Overactive Bladder (OAB)

Intervention / Treatment
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* Other: Non-Interventional


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have at least one dispensing of any medication between January 22, 2016 and December 31, 2016. Inclusion Criteria for Korea: Have at least one dispensing of any medication between January 1st, 2016 and December 31, 2016. Participant was diagnosed with OAB (ICD-10 N32.8, N31.0, N31.1, N31.2, N31.8, N31.9, N32.9, N39.8 and N39.40) at index date. Participant did not have dispensing record of an OAB medication during the washout period (6 months prior to the index date). Exclusion Criteria: Participants who do not have a complete year of data availability in the database prior to index date. Have record of hospitalization on the index date. Exclusion Criteria for Korea: Participant was hospitalized on the index date. Participant did not have an active insurance status during the washout period or on the index date. Participant received onabotulinumtoxin A and/or surgical intervention as part of the OAB treatment during the washout period. Participant was diagnosed with stress incontinence (ICD-10 N39.3 or equivalent) or had dispensing record of medication for stress incontinence (duloxetine) during the washout period. Participant was diagnosed with urinary tract infection (ICD-10 N30.0 and N39.0 or equivalent) during the washout period or on the index date.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Subjects With Overactive Bladder Treatment<br>Subjects who have dispensing records for treatment of overactive bladder will be included | Other: Non-Interventional<br>* Overview of anticholinergic burden, rather than to evaluate specific drugs<br>|
| Subjects Without Overactive Bladder Treatment<br>Subjects who do not have dispensing records for treatment of overactive bladder will be included | Other: Non-Interventional<br>* Overview of anticholinergic burden, rather than to evaluate specific drugs<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anticholinergic Cognitive Burden (ACB) score | ACB will be calculated based on methodology from Campbell et al (2016). Sum (Drug A #days prescribed X ACB scale score) + (Drug B #days prescribed X ACB scale score) + (Drug X…)/Number of days with any medication prescribed. The cumulative score has a range from 0 to infinity, with higher values indicating a higher cumulative anticholinergic burden of the patient. | 100 days | 
| Korea Specific: Percentage of Participants With any Listed Anticholinergic Use | This will be calculated as number of participants with any listed anticholinergics use divided by number of participants fulfilling the general eligibility criteria of the study (in each study dataset) multiplied by 100. | 100 days | 
| Korea Specific: Percentage of Participants With Strong Anticholinergic Use | This will be calculated as number of participants with strong anticholinergics use divided by number of participants fulfilling the general eligibility criteria of the study (in each study dataset) multiplied by 100. | 100 days | 
| Korea Specific: Number of Anticholinergics Dispensed per Participants | This will be calculated as total number of anticholinergics dispensed divided by number of participants fulfilling the general eligibility criteria of the study (in each study dataset) multiplied by 100. | 100 days | 
| Korea Specific: Attribution Proportion of OAB medications to total ACB in OAB Cohort | Attribution proportion of OAB medication to total ACB will be calculated as the ratio between the sum over all OAB patients of the ACB scores of each OAB medication multiplied by the number of days supply in the numerator and the sum over all OAB patients of the ACB scores of each antimuscarinic medication multiplied by the number of days supply in the denominator. | 100 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Median percentage of ACB score derived from overactive bladder (OAB) treatment(s) in total ACB score | The attribution of antimuscarinics for OAB treatment to entire anticholinergic exposures in OAB patients. | 100 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anticholinergic burden, anticholinergic, overactive bladder