Measuring atopic dermatitis severity in randomized controlled clinical trials: What exactly are we measuring?
Measuring atopic dermatitis severity in randomized controlled clinical trials: What exactly are we measuring?
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DOI：
10.1046/j.1523-1747.2003.12251.x
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发表时间：
2003-06-01
影响因子：
6.5
通讯作者：
Williams, H
中科院分区：
文献类型：
--
作者：
Charman, C;Chambers, C;Williams, H
精心设计的临床试验是循证医学的一个基本方面。这些试验依赖于使用有效、可靠和相关的结局指标。结果方法的广泛差异可能对结果的正确解释和比较产生重要的不利影响。本研究的目的是描述1994年1月至2001年12月发表的特应性皮炎治疗干预措施的随机对照试验中结局方法的变化。在使用系统性电子数据库检索策略确定的93项合格随机对照试验中，85项（91%）纳入了临床体征的客观测量。然而，这些试验中只有23项（27%）使用了已发表的严重程度量表。其余的使用了已发表量表的修改版本（14%）或未命名的量表，没有有效性或可靠性的数据（59%），尽管与以前相比，未发表的量表在过去2年中使用的频率明显降低（21%vs74%，p
Well-designed clinical trials are a fundamental aspect of evidence-based medicine. Such trials are dependent on the use of valid, reliable, and relevant outcome measures. Wide variation in outcome methodology can have important detrimental effects on the correct interpretation and comparison of results. The objective of this study was to describe the variation in outcome methodology in randomized controlled trials of therapeutic interventions for atopic dermatitis published between January 1994 and December 2001. Of the 93 eligible randomized controlled trials identified using a systematic electronic database search strategy, 85 (91%) incorporated an objective measurement of clinical signs. Only 23 (27%) of these trials used a published severity scale, however. The remainder used either modified versions of published scales (14%) or unnamed scales with no data on validity or reliability (59%), although unpublished scales were used significantly less frequently over the last 2 y compared to previously (21%vs 74%, p