COPD 研究中的亚人群和中间结局设计（SPIROMICS）。
Design of the Subpopulations and Intermediate Outcomes in COPD Study (SPIROMICS).
机构信息
Department of Biostatistics, University of North Carolina at Chapel Hill, , Chapel Hill, North Carolina, USA.
出版信息
Thorax. 2014 May;69(5):491-4. doi: 10.1136/thoraxjnl-2013-203897. Epub 2013 Sep 12.
Abstract
Subpopulations and Intermediate Outcomes in COPD Study (SPIROMICS) is a multicentre observational study of chronic obstructive pulmonary disease (COPD) designed to guide future development of therapies for COPD by providing robust criteria for subclassifying COPD participants into groups most likely to benefit from a given therapy during a clinical trial, and identifying biomarkers/phenotypes that can be used as intermediate outcomes to reliably predict clinical benefit during therapeutic trials. The goal is to enrol 3200 participants in four strata. Participants undergo a baseline visit and three annual follow-up examinations, with quarterly telephone calls. Adjudication of exacerbations and mortality will be undertaken.
摘要
慢性阻塞性肺疾病研究中的亚群和中间结局（SPIROMICS）是一项多中心观察性研究，旨在通过为慢性阻塞性肺疾病（COPD）参与者提供将其分为最有可能从临床试验中的特定治疗中获益的组的稳健标准，并确定可作为中间结局用于可靠预测治疗试验中的临床获益的生物标志物/表型，来指导未来 COPD 治疗方法的开发。目标是在四个层次中招募 3200 名参与者。参与者接受基线访问和三次年度随访检查，并进行季度电话随访。将进行加重和死亡率的裁决。
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