Replication of the INSPIRE Trial in Healthcare Claims Data
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 98,278
- 试验地点
- 1
- 主要终点
- Healthcare utilization exacerbation rate per year
研究概览
简要总结
Investigators are building an empirical evidence base for real world data through large-scale replication of randomized controlled trials. The investigators' goal is to understand for what types of clinical questions real world data analyses can be conducted with confidence and how to implement such studies.
详细描述
This is a non-randomized, non-interventional study that is part of the RCT DUPLICATE initiative (www.rctduplicate.org) of the Brigham and Women's Hospital, Harvard Medical School. It is intended to replicate, as closely as is possible in healthcare insurance claims data, the trial listed below/above. Although many features of the trial cannot be directly replicated in healthcare claims, key design features, including outcomes, exposures, and inclusion/exclusion criteria, were selected to proxy those features from the trial. Randomization is also not replicable in healthcare claims data but was proxied through a statistical balancing of measured covariates according to standard practice. Investigators assume that the RCT provides the reference standard treatment effect estimate and that failure to replicate RCT findings is indicative of the inadequacy of the healthcare claims data for replication for a range of possible reasons and does not provide information on the validity of the original RCT finding.
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
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 40-80 years [0,0] days
- •Diagnosis of COPD [all available data, 0] days
- •Clinical history of at least 1 COPD exacerbation [all available data, -43] days
排除标准
- •COPD exacerbation [-42, 0] days
- •Asthma, eczema, atopic dermatitis, allergic rhinitis [-180, 0] days
- •Known respiratory disorder other than COPD e.g. pulmonary fibrosis or interstitial lung disease (ILD), sarcoidosis, lymphangioleiomyomatosis, primary/pulmonary tuberculosis, cystic fibrosis, pulmonary hypertension/other pulmonary heart disease, lung/pulmonary malignancies, alpha-1 antitrypsin deficiency, pneumoconioses and other lung diseases due to external agents [all available data, 0] days
- •Narrow angle glaucoma or prostatic hyperplasia or obstruction of the neck of the bladder [-180, 0] days
- •At least one 30-day supply prescription claims for oral alfuzosin, doxazosin, tamsulosin, silodosin, finasteride 5 mg, dutasteride [-180,0] days
- •Lung transplant or lung volume reduction surgery (LVRS) [all available data, 0] days
- •Daily long term oxygen therapy (LTOT) [all available data, 0] days
- •Beta-blockers (except eye drops) [-180, 0] days
- •Evidence of alcohol, drug or solvent abuse [-180, 0] days
- •Use of salmeterol, tiotropium and fluticasone containing inhaler use [-180, 0] days
研究组 & 干预措施
Tiotropium
Reference group
干预措施: Tiotropium (Drug)
Salmeterol/Fluticasone
Exposure group
干预措施: salmeterol-fluticasone (Drug)
结局指标
主要结局
Healthcare utilization exacerbation rate per year
时间窗: Through study completion or censoring, up to 193 days
Claims-based algorithm: healthcare utilization exacerbation rate per year
次要结局
未报告次要终点
研究者
Shirley Vichy Wang
Assistant Professor
Brigham and Women's Hospital