A Retrospective Database Analysis of Anticholinergic Burden Among the Elderly With and Without Overactive Bladder in Australia and South Korea
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6,295,279
- 试验地点
- 2
- 主要终点
- Korea Specific: Percentage of Participants With any Listed Anticholinergic Use
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have at least one dispensing of any medication between January 22, 2016 and December 31,
- •Inclusion Criteria for Korea:
- •Have at least one dispensing of any medication between January 1st, 2016 and December 31,
- •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).
排除标准
- •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.
结局指标
主要结局
Korea Specific: Percentage of Participants With any Listed Anticholinergic Use
时间窗: 100 days
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.
Korea Specific: Number of Anticholinergics Dispensed per Participants
时间窗: 100 days
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.
Anticholinergic Cognitive Burden (ACB) score
时间窗: 100 days
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.
Korea Specific: Percentage of Participants With Strong Anticholinergic Use
时间窗: 100 days
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.
Korea Specific: Attribution Proportion of OAB medications to total ACB in OAB Cohort
时间窗: 100 days
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.
次要结局
- Median percentage of ACB score derived from overactive bladder (OAB) treatment(s) in total ACB score(100 days)