Regression to the mean in multiple sclerosis

Regression to the mean in multiple sclerosis
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DOI:
10.1177/1352458506070820
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发表时间:
2006-12-01
影响因子:
5.8
通讯作者:
Arbizu, Tx
Arbizu, Tx
中科院分区:
医学2区
文献类型:
--
作者:
Martinez-Yelamos, S.;Martinez-Yelamon, A.;Arbizu, Tx

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为了确保足够的疾病活动性,复发缓解型(RR)多发性硬化症(MS)患者通常被纳入随机安慰剂对照试验,只有当他们具有高基线活动性时。这些患者在研究前阶段的演变是不寻常的,当随访一段时间后,他们往往会表现出更常见的行为。这种现象被称为回归均值。在正确解释无安慰剂对照组治疗队列的长期研究时,应考虑平均值的回归,该研究使用基线期作为对照。本研究的目的是评价这种现象在未接受治疗的RRMS患者队列中的相关性,这些患者的选择标准与随机安慰剂对照临床试验中使用的标准相似。44例明确RRMS患者,在过去两年中有两次或两次以上复发,基线EDSS
In order to ensure sufficient disease activity, patients with relapsing remitting (RR) multiple sclerosis (MS) are often included in randomized placebo-controlled trials, only if they have a high baseline activity. These patients, whose evolution is unusual in the pre-study period, will tend to show a more usual behavior when followed up over a period of time. This phenomenon is known as regression to the mean. Regression to the mean should be taken into account in correctly interpreting long-term studies of cohorts treated without a placebo control group, which use the baseline period as control. The aim of this study was to evaluate the relevance of this phenomenon in a non-treated cohort of RRMS patients, selected with similar criteria to those used in randomized placebo-controlled clinical trials. Forty-four patients with definite RRMS, with two or more relapses in the previous two years, and a baseline EDSS