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Quality assurance of asthma clinical trials.

机译：哮喘临床试验的质量保证。

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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.
机译：肺活量测定法测量的准确性和可重复性对于在随机哮喘临床试验中获得可靠的疗效数据至关重要。我们报告了我们在III期哮喘试验中实施的集中式肺活量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次为期4至21周的哮喘试验。从2523名成人和336名小儿哮喘患者中收集了大约23100支支气管扩张剂前和13700支支气管扩张剂后肺功能测试。该程序使用了标准的肺活量计（Renaissance肺活量测定系统），并带有机动质量信息和肺活量测定测试的自动质量评分。每个临床中心每周将肺活量测定数据传输到中央数据库，在该数据库中对数据质量进行统一监控，并在每周质量报告中提供反馈。所有患者中有百分之九十九进行了肺活量测定，其质量达到或超过了美国胸科学会的标准，并且随着时间的推移而有所改善。高质量的肺活量测定与（1）较轻的哮喘相关; （2）积极治疗; （3）很少的夜间觉醒; （四）15岁以上; （5）体重低。机动性支气管痉挛很少见。在采用标准肺活量计和连续监测的多中心哮喘临床试验中观察到了高质量的肺活量测定法。病人内和病人之间的变异性均下降。随着研究参与者和技术人员经验的积累，肺活量测定的质量随时间而提高。

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