Establishing the Benefits of Adherence to Enlarged Prostate Treatment: A Validation Study Linking Adherence to Outcomes Using the Market Scan Database
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54,459
- 主要终点
- The occurence of a diagnosis code for acute urinary retention (AUR) or a procedure code for prostate surgery
研究概览
简要总结
Adherence and length of therapy with 5-alpha reductase inhibitor (5ARI) treatment may be associated with improved clinical outcomes of enlarged prostate (EP) as well as lower health care costs.
The objective of this retrospective database analysis is to quantify the relationship between adherence and length of therapy with a 5ARI and the likelihood of acute urinary retention (AUR) or prostate surgery (emergency and non-emergency) in patients with benign prostatic hyperplasia (BPH). The study will also measure the economic impact associated with these medical encounters.
The MarketScan database contains data from people with commercial health insurance and Medicare and includes both medical and pharmacy data that are sourced directly from health plans and employers. Approximately 18 million covered lives will be utilized for this study in the time period from January 1, 2003 to September 30, 2009.
This study is a retrospective cohort analysis of medical claims data.
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Aged 50 years or older
- •A diagnostic claim of benign prostatic hyperplasia (International Classification of Diseases, Ninth Revision, Clinical Modification [ICD-9-CM] codes 222.2x or 600.xx)
- •A prescription claim for a 5-alpha reductase inhibitor (5ARI) for at least 60 days during the observation period
- •Continuous health plan eligibilitiy for 6 months prior to and at least 150 days after the initial 5ARI prescription
排除标准
- •A diagnosis of prostate cancer (ICD-9-CM codes 185.xx, 198.82, 233.4, 236.5, 239.5, V10.46)
- •A diagnosis of bladder cancer (ICD-9-CM codes 188.xx, 198.1, 223.3, 233.7, 239.4, V10.51),
- •A procedure code for any prostate-related surgery prior to the index date or 150 days after the index date
- •A diagnosis code for acute urinary retention (AUR) prior to the index date or 150 days after the index date
研究组 & 干预措施
Adherent BPH patients
Patients with benign prostatic hyperplasia (BPH) who are adherent to 5-alpha reductase inhibitor (5ARI) therapy based on a medication possession ratio (MPR). Analyses will be conducted with threshold adherence levels of 70%, 75% and 80%
干预措施: 5-alpha Reductase Inhibitor (5ARI) (Drug)
Non-adherent BPH patients
Patients with BPH who are not adherent to 5ARI therapy based on an MPR and threshold levels of less than 70%, less than 75% and less than 80%
干预措施: 5-alpha Reductase Inhibitor (5ARI) (Drug)
结局指标
主要结局
The occurence of a diagnosis code for acute urinary retention (AUR) or a procedure code for prostate surgery
时间窗: One year following the first date of 5ARI therapy
The occurence of a code for either AUR or prostate surgery will be identified for patients who were adherent with 5ARI therapy as measured with a medication possession ratio (MPR)
次要结局
- Mean costs associated with AUR or prostate surgery(One year following the first date of 5ARI therapy)