Casaburi Richard, Merrill Debora, Dolmage Thomas, Garcia-Aymerich Judith, Fageras Malin, Goldstein Roger, Harding Gale, Kline Leidy Nancy, Maltais Francois, O'Donnell Denis, Porszasz Janos, Puente-Maestu Luis, Rennard Stephen, Sciurba Frank, Spruit Martijn A, Tal-Singer Ruth, Tetzlaff Kay, Van't Hul Alex, Yu Ren, Hamilton Alan
Rehabilitation Clinical Trials Center, Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Torrance, California, United States.
COPD Foundation, Miami, Florida, United States.
Chronic Obstr Pulm Dis. 2022 Oct 26;9(4):520-537. doi: 10.15326/jcopdf.2022.0331.
The COPD Biomarkers Qualification Consortium (CBQC) was formed under COPD Foundation management, with the goal of qualifying biomarkers and clinical outcome assessments through established regulatory processes for chronic obstructive pulmonary disease (COPD). Within CBQC, a working group evaluated opportunities for qualification of an exercise endurance measure. In a recent publication ( 2022; 9[2]:252-265), we described a conceptual framework establishing exercise endurance's direct relationship to an individual with COPD's experience of physical functioning in daily life, and that increase in exercise endurance is a patient-centered, meaningful treatment benefit. We further proposed endurance time during constant work rate cycle ergometery (CWRCE) as a useful efficacy endpoint in clinical therapeutic intervention trials. In this current publication, we describe the process of assembling an integrated database of endurance time responses to interventions in COPD.
We sought participant-level data from published studies incorporating CWRCE as an outcome measure. A literature search screened 2993 publications and identified 553 studies for assessment. Two interventions had sufficient data across studies to warrant data extraction: bronchodilators and rehabilitative exercise training. Investigators were contacted and requested to provide participant-by-participant data from their published studies.
The final dataset included data from 8 bronchodilator studies (2166) participants and 15 exercise training studies (3488 participants). The database includes 71 variables per participant, comprising demographic, pulmonary function, and detailed physiologic response data. This paper provides a detailed description of the analysis population, while analysis supporting the validation/qualification process and addressing other scientific questions will be described in subsequent publications.
慢性阻塞性肺疾病生物标志物鉴定联盟（CBQC）在慢性阻塞性肺疾病基金会的管理下成立，目标是通过既定的监管程序对慢性阻塞性肺疾病（COPD）的生物标志物和临床结局评估进行鉴定。在CBQC内部，一个工作组评估了运动耐力测量指标的鉴定机会。在最近的一篇出版物（2022；9[2]：252 - 265）中，我们描述了一个概念框架，该框架确立了运动耐力与COPD个体日常生活身体功能体验之间的直接关系，并且运动耐力的提高是以患者为中心的、有意义的治疗益处。我们还进一步提出，在恒定工作率周期测力计（CWRCE）测试中的耐力时间可作为临床治疗干预试验中一个有用的疗效终点。在本出版物中，我们描述了组装一个关于COPD干预耐力时间反应的综合数据库的过程。
我们从已发表的将CWRCE作为结局指标的研究中获取参与者层面的数据。文献检索筛选了2993篇出版物，并确定了553项研究进行评估。有两项干预措施在各项研究中有足够的数据，值得进行数据提取：支气管扩张剂和康复运动训练。我们联系了研究人员，要求他们提供已发表研究中逐个参与者的数据。
最终数据集包括来自8项支气管扩张剂研究（2166名参与者）和15项运动训练研究（3488名参与者）的数据。该数据库包括每位参与者的71个变量，包括人口统计学、肺功能和详细的生理反应数据。本文详细描述了分析人群，而支持验证/鉴定过程以及解决其他科学问题的分析将在后续出版物中描述。
