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首页> 外文期刊>Annals of the American Thoracic Society >Performance of the EXAcerbations of chronic pulmonary disease tool patient-reported outcome measure in three clinical trials of chronic obstructive pulmonary disease
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Performance of the EXAcerbations of chronic pulmonary disease tool patient-reported outcome measure in three clinical trials of chronic obstructive pulmonary disease

机译：慢性阻塞性肺疾病的三项临床试验中，患者报告的慢性肺疾病EXAcerbations的效果

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Rationale: The EXAcerbations of Chronic Pulmonary Disease Tool (EXACT) is a patient-reported outcome measure to standardize the symptomatic assessment of chronic obstructive pulmonary disease exacerbations, including reported and unreported events. The instrument has been validated in a short-term study of patients with acute exacerbation and stable disease; its performance in longer-term studies has not been assessed. Objectives: To test the EXACT's performance in three randomized controlled trials and describe the relationship between resource-defined medically treated exacerbations (MTEs) and symptom (EXACT)-defined events. Methods: Prespecified secondary analyses of data from phase II randomized controlled trials testing new drugs for the management of chronic obstructive pulmonary disease: one 6-month trial (United States) (n = 235) and two 3-month, multinational trials (AZ 1 [n = 749], AZ 2 [n = 597]). In each case, the experimental drugs were found to be ineffective, permitting assessment of the EXACT's performance in three independent studies of moderate to severe high-risk patients on maintenance therapies. Measurements and Main Results: The mean age of subjects was 62 to 64 years; 48 to 76% were male. Mean FEV1 % predicted was 42 to 59%. EXACT scores exhibited internal consistency (Cronbach's α ≥ 0.90), reproducibility (intraclass correlation 0.70), correlation with St. George's Respiratory Questionnaire (Spearman rho [rs] = 0.62, 0.46, 0.46 in the three trials; P 0.001), and Breathlessness Cough and Sputum Scale (AZ 1, rs = 0.83; AZ 2, rs = 0.83; P 0.001). EXACT-defined events had a high correspondence with alternative indicators of worsening (94, 88, and 93%). In each trial, unreported events were similar in severity (mean EXACT score, 56, 57, 61 vs. 53, 54 [P 0.05], 57 [P 0.05], respectively; 100-point scale) and longer (median, 9, 8, 7 vs. 8, 7 [P 0.01], 6 days, respectively) than moderate MTEs. Conclusions: Data generated through the EXACT offers insight into the symptomatic nature of MTEs and the frequency, severity, and duration of unreported symptom-defined events. Clinical trials registered with www.clinicaltrials.gov (MPEX: NCT00739648; AZ 1: NCT00949975; AZ 2: NCT01023516).
机译：原理：慢性肺疾病检查工具（EXACT）是一项患者报告的结局指标，用于标准化慢性阻塞性肺疾病恶化的症状评估，包括已报告和未报告的事件。该仪器已在急性加重和疾病稳定患者的短期研究中得到验证;尚未评估其在长期研究中的表现。目的：在三个随机对照试验中测试EXACT的性能，并描述资源定义的药物加重（MTE）与症状（EXACT）定义的事件之间的关系。方法：对来自用于治疗慢性阻塞性肺疾病的新药的II期随机对照试验的II期数据的预先指定的二次分析：一项为期6个月的试验（美国）（n = 235）和两项为期3个月的跨国试验（AZ 1） [n = 749]，AZ 2 [n = 597]）。在每种情况下，都发现实验药物无效，因此可以在三项针对中度至重度高危患者进行维持疗法的独立研究中评估EXACT的性能。测量和主要结果：受试者的平均年龄为62至64岁。男性占48％至76％。预测的平均FEV1％为42％至59％。 EXACT评分显示出内部一致性（Cronbach'sα≥0.90），可重复性（类内相关性> 0.70），与圣乔治呼吸问卷的相关性（三个试验中Spearman rho [rs] = 0.62、0.46、0.46; P <0.001），以及呼吸困难咳嗽和痰量表（AZ 1，rs = 0.83; AZ 2，rs = 0.83; P <0.001）。确切定义的事件与恶化的其他指标高度对应（94％，88％和93％）。在每项试验中，未报告事件的严重程度相似（平均精确评分分别为56、57、61和53、54 [P <0.05]，57 [P <0.05]; 100分制），且时间更长（中位数，分别是中度MTE的9、8、7与8、7 [P <0.01]，6天）。结论：通过EXACT生成的数据可洞悉MTE的症状性质以及未报告症状定义事件的频率，严重程度和持续时间。在www.clinicaltrials.gov上注册的临床试验（MPEX：NCT00739648; AZ 1：NCT00949975; AZ 2：NCT01023516）。

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