肺清除指数：用于囊性纤维化临床试验的证据。
Lung clearance index: evidence for use in clinical trials in cystic fibrosis.
作者信息
Kent L, Reix P, Innes J A, Zielen S, Le Bourgeois M, Braggion C, Lever S, Arets H G M, Brownlee K, Bradley J M, Bayfield K, O'Neill K, Savi D, Bilton D, Lindblad A, Davies J C, Sermet I, De Boeck K
机构信息
Centre for Health and Rehabilitation Technologies (CHaRT), Institute for Nursing and Health Research, University of Ulster, Newtownabbey, UK; Regional Cystic Fibrosis Centre, Belfast Health and Social Care Trust, Belfast, UK.
Centre de Référence de la Mucoviscidose, Hospices Civils de Lyon, Lyon, France.
出版信息
J Cyst Fibros. 2014 Mar;13(2):123-38. doi: 10.1016/j.jcf.2013.09.005. Epub 2013 Dec 5.
The ECFS-CTN Standardisation Committee has undertaken this review of lung clearance index as part of the group's work on evaluation of clinical endpoints with regard to their use in multicentre clinical trials in CF. The aims were 1) to review the literature on reliability, validity and responsiveness of LCI in patients with CF, 2) to gain consensus of the group on feasibility of LCI and 3) to gain consensus on answers to key questions regarding the promotion of LCI to surrogate endpoint status. It was concluded that LCI has an attractive feasibility and clinimetric properties profile and is particularly indicated for multicentre trials in young children with CF and patients with early or mild CF lung disease. This is the first article to collate the literature in this manner and support the use of LCI in clinical trials in CF.
欧洲囊性纤维化临床研究网络标准化委员会开展了此次肺清除指数审查，作为该组织关于评估临床终点在囊性纤维化多中心临床试验中应用的工作的一部分。目标如下：1）回顾关于囊性纤维化患者肺清除指数的可靠性、有效性和反应性的文献；2）就肺清除指数的可行性达成小组共识；3）就将肺清除指数提升至替代终点地位的关键问题的答案达成共识。得出的结论是，肺清除指数具有吸引人的可行性和临床测量特性，尤其适用于囊性纤维化幼儿以及早期或轻度囊性纤维化肺病患者的多中心试验。这是第一篇以这种方式整理文献并支持在囊性纤维化临床试验中使用肺清除指数的文章。
Zotero 插件