Malmstrom Kerstin, Peszek Iza, Lu Susan, Enright Paul L, Reiss Theodore F
Department of Pulmonary Immunology, Merck Research Laboratories, PO Box 2000, Rahway, NJ 07065, USA.
Control Clin Trials. 2002 Apr;23(2):143-56. doi: 10.1016/s0197-2456(01)00197-0.
Accuracy and repeatability of spirometry measurements are essential to obtain reliable efficacy data in randomized asthma clinical trials. We report our experience with a centralized spirometry quality assurance program that we implemented in our phase III asthma trials. Six asthma trials of 4 to 21 weeks in duration were conducted at 232 clinical centers in 31 countries. Approximately 23,100 prebronchodilator and 13,700 postbronchodilator spirometry tests were collected from 2523 adult and 336 pediatric asthmatic patients. The program used a standard spirometer (the Renaissance spirometry system) with maneuver quality messages and automated quality grading of the spirometry tests. Each clinical center transmitted spirometry data weekly to a central database, where uniform monitoring of data quality was performed and feedback was provided in weekly quality reports. Seventy-nine percent of all patients performed spirometry sessions with quality that either met or exceeded American Thoracic Society standards and improved over time. Good-quality spirometry was associated with (1) less severe asthma; (2) active treatment; (3) infrequent nocturnal awakenings; (4) age above 15 years; and (5) low body weight. Maneuver-induced bronchospasm was rare. Good-quality spirometry was observed in multicenter asthma clinical trials that employed a standard spirometer and continuous monitoring. Both within- and between-patient variability decreased. Spirometry quality improved with time as study participants and technicians gained experience.
在随机化哮喘临床试验中，肺功能测定的准确性和可重复性对于获得可靠的疗效数据至关重要。我们报告了在我们的III期哮喘试验中实施的一项集中式肺功能测定质量保证计划的经验。在31个国家的232个临床中心进行了6项为期4至21周的哮喘试验。从2523名成年和336名儿科哮喘患者中收集了约23100次支气管扩张剂前和13700次支气管扩张剂后肺功能测定测试。该计划使用了带有操作质量信息和肺功能测定测试自动质量分级的标准肺功能仪（复兴肺功能测定系统）。每个临床中心每周将肺功能测定数据传输到一个中央数据库，在那里对数据质量进行统一监测，并在每周的质量报告中提供反馈。79%的患者进行的肺功能测定质量达到或超过了美国胸科学会标准，并且随着时间的推移有所改善。高质量的肺功能测定与以下因素相关：（1）哮喘病情较轻；（2）积极治疗；（3）夜间觉醒不频繁；（4）年龄超过15岁；（5）体重较低。操作诱发的支气管痉挛很少见。在采用标准肺功能仪和持续监测的多中心哮喘临床试验中观察到了高质量的肺功能测定。患者内和患者间的变异性均降低。随着研究参与者和技术人员获得经验，肺功能测定质量随时间得到改善。
