Suspected acute exacerbation of idiopathic pulmonary fibrosis as an outcome measure in clinical trials.
Suspected acute exacerbation of idiopathic pulmonary fibrosis as an outcome measure in clinical trials.
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DOI：
10.1186/1465-9921-14-73
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发表时间：
2013-07-13
影响因子：
5.8
通讯作者：
IPFnet investigators
中科院分区：
文献类型：
--
作者：
Collard HR;Yow E;Richeldi L;Anstrom KJ;Glazer C;IPFnet investigators
特发性肺纤维化急性加重已成为临床试验的重要指标。本研究旨在探讨疑似急性加重的概念作为一种结果测量。三名研究者回顾性地回顾了西地那非在IPF运动表现试验中的受试者，这些受试者在研究过程中经历了严重的呼吸不良事件。事件被分类为明确急性加重，疑似急性加重，或其他，根据既定标准。确定了35个事件。确诊急性加重4例，疑似急性加重14例，其他17例。确诊和疑似急性加重在临床上难以区分。这两种疾病在冬季和春季最常见，并与疾病进展和短期死亡的高风险相关。在这项研究中，一半的呼吸系统严重不良事件归因于明确或疑似急性加重。疑似急性加重在临床上与明确急性加重难以区分，代表有临床意义的事件。临床试验人员应考虑捕捉明确的和疑似的急性加重作为结果测量。
Acute exacerbation of idiopathic pulmonary fibrosis has become an important outcome measure in clinical trials. This study aimed to explore the concept of suspected acute exacerbation as an outcome measure. Three investigators retrospectively reviewed subjects enrolled in the Sildenafil Trial of Exercise Performance in IPF who experienced a respiratory serious adverse event during the course of the study. Events were classified as definite acute exacerbation, suspected acute exacerbation, or other, according to established criteria. Thirty-five events were identified. Four were classified as definite acute exacerbation, fourteen as suspected acute exacerbation, and seventeen as other. Definite and suspected acute exacerbations were clinically indistinguishable. Both were most common in the winter and spring months and were associated with a high risk of disease progression and short-term mortality. In this study one half of respiratory serious adverse events were attributed to definite or suspected acute exacerbations. Suspected acute exacerbations are clinically indistinguishable from definite acute exacerbations and represent clinically meaningful events. Clinical trialists should consider capturing both definite and suspected acute exacerbations as outcome measures.
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影响因子：
158.5
作者：
Richeldi, Luca;Costabel, Ulrich;du Bois, Roland M.
通讯作者：
du Bois, Roland M.
影响因子：
168.9
作者：
Noble, Paul W.;Albera, Carlo;du Bois, Roland M.
通讯作者：
du Bois, Roland M.
DOI：
10.1164/rccm.2009-040gl
发表时间：
2011-03-15
影响因子：
24.7
作者：
Raghu, Ganesh;Collard, Harold R.;Schuenemann, Holger J.
通讯作者：
Schuenemann, Holger J.
影响因子：
9.6
作者：
Olson, Amy L.;Swigris, Jeffrey J.;Brown, Kevin K.
通讯作者：
Brown, Kevin K.
DOI：
10.1164/rccm.200703-463pp
发表时间：
2007-10-01
影响因子：
24.7
作者：
Collard, Harold R.;Moore, Bethany B.;Martinez, Fernando J.
通讯作者：
Martinez, Fernando J.