Rabe E, Partsch H, Jünger M, Abel M, Achhammer I, Becker F, Cornu-Thenard A, Flour M, Hutchinson J, Issberner K, Moffatt Ch, Pannier F
Department of Dermatology, University of Bonn, Germany.
Eur J Vasc Endovasc Surg. 2008 Apr;35(4):494-500. doi: 10.1016/j.ejvs.2007.08.006. Epub 2008 Feb 4.
The scientific quality of published clinical trials is generally poor in studies where compression devices have been assessed in the management of venous disease. The authors' aim was to establish a set of guidelines which could be used in the design of future clinical trials of compression treatments for venous diseases.
Consensus conference leading to a consensus statement.
The authors form a expert consensus group known as the International Compression Club (ICC). This group obtained published medical literature in the field of compression treatment in venous disease by searching medical literature databases. The literature was studied by the group which attended a consensus meeting. A draft document was circulated to ICC members and revised until agreement between contributors was reached.
The authors have prepared a set of guidelines which should be given consideration when conducting studies to assess the efficacy of compression in venous disease.
The form of compression therapy including the comparators used in the clinical study must be clearly characterised. In future studies the characteristics of the material provided by the manufacturer should be described including in vivo data on pressure and stiffness of the final compression system. The pressure exerted on the distal lower leg should be stated in mmHg and the method of pressure determination must be quoted.
在评估用于静脉疾病管理的加压装置的研究中，已发表的临床试验的科学质量普遍较差。作者的目的是制定一套指南，可用于未来静脉疾病加压治疗临床试验的设计。
达成共识声明的共识会议。
作者组建了一个名为国际加压俱乐部（ICC）的专家共识小组。该小组通过检索医学文献数据库获取静脉疾病加压治疗领域已发表的医学文献。小组成员研究这些文献并参加了共识会议。一份文件草案分发给ICC成员并进行修订，直至贡献者之间达成一致。
作者制定了一套指南，在进行评估静脉疾病加压疗效的研究时应予以考虑。
必须明确描述包括临床研究中使用的对照物在内的加压治疗形式。在未来的研究中，应描述制造商提供的材料特性，包括最终加压系统的压力和硬度的体内数据。施加于小腿远端的压力应以毫米汞柱表示，并且必须引用压力测定方法。
