Paris 7 Denis Diderot University, Medecine Faculty, Paris, France.
J Clin Epidemiol. 2011 May;64(5):463-70. doi: 10.1016/j.jclinepi.2010.06.008. Epub 2010 Dec 15.
To describe the pain decrease considered as clinically relevant when designing a trial and reporting its results.
A systematic review of the literature in MEDLINE was conducted to select randomized controlled trials (RCTs) with pain as a primary outcome. Data extracted included the definition (terms and values) of a clinically relevant difference in pain, the type of pain studied (acute or chronic), the level of application (group or individual) of the clinically relevant difference, and the reference justifying the choice of value for clinically relevant difference.
Seventy-four trials were included, and only 16 articles justified the choice of a value for clinically relevant difference with a reference citation. The values chosen for the clinically relevant relative decrease in pain varied from 4 to 40 mm or from 15% to 55% at the group level and from 20 to 50 mm at the individual level. In seven articles, the authors confused the application of the reference value at the individual or group level.
Our review revealed a great heterogeneity in definition, format, and values of what is considered a clinically relevant difference in pain in RCTs of analgesics, and standardizations are advisable.
描述在试验设计和结果报告中被认为具有临床相关性的疼痛减轻程度。
对 MEDLINE 中的文献进行系统综述,以选择以疼痛为主要结局的随机对照试验(RCT)。提取的数据包括疼痛临床相关差异的定义(术语和值)、研究的疼痛类型(急性或慢性)、临床相关差异的应用水平(组或个体),以及为临床相关差异选择值的参考依据。
共纳入 74 项试验,只有 16 篇文章引用参考资料证明了临床相关差异值的选择是合理的。在组水平上,为临床相关的疼痛相对减轻选择的数值从 4 到 40 毫米或从 15%到 55%不等,在个体水平上从 20 到 50 毫米不等。在 7 篇文章中,作者混淆了参考值在个体或组水平上的应用。
我们的综述显示,在镇痛药的 RCT 中,疼痛的临床相关差异的定义、形式和数值存在很大的异质性,建议进行标准化。