N of 1 trials in diabetes: making individual therapeutic decisions

N of 1 trials in diabetes: making individual therapeutic decisions
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DOI:
10.1007/s00125-008-0983-2
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发表时间:
2008-06-01
期刊:
影响因子:
8.2
通讯作者:
Matthews, D. R.
Matthews, D. R.
中科院分区:
医学1区
文献类型:
--
作者:
Tsapas, A.;Matthews, D. R.

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N/1试验是单受试者、随机、交叉研究,其中患者作为自己的对照,以比较治疗的疗效。它们提供了一种替代大型随机临床试验的方法,这些临床试验的适用性有限,而经验检验本质上是任意的。N/1试验被视为为个体受试者决策提供最高强度的证据。它们依赖于患者表达偏好并共同决定未来的治疗,因此可能导致生活方式干预的成功实施。N/1试验是在糖尿病等慢性疾病中做出治疗决策的最佳方法,其中决策通常依赖于任意标准和临床判断。
N of 1 trials are single-subject, randomised, crossover studies, in which the patient serves as their own control to compare the efficacy of a treatment. They offer an alternative to large, randomised clinical trials, which have limited applicability, and empirical testing, which is arbitrary in nature. N of 1 trials are regarded as providing the highest strength of evidence for individual subject decisions. They rely upon the patient expressing preferences and making shared decisions for determining the future therapy, and may therefore lead to the successful implementation of lifestyle interventions. N of 1 trials are an optimal approach for making therapeutic decisions in chronic diseases like diabetes mellitus, where decision-making is often reliant upon arbitrary criteria and clinical judgement.