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[慢性阻塞性肺疾病(COPD)的试验终点:最小临床重要差异]

[Trial end-point in chronic obstructive pulmonary disease (COPD): minimal clinically important difference].

作者信息

Gillissen A, Buhl R, Kardos P, Puhan M, Rabe K F, Rothe T, Sauer R, Welte T, Worth H, Menz G

机构信息

Robert Koch-Klinik, Thoraxzentrum des Klinikums St. Georg Leipzig.

出版信息

Pneumologie. 2008 Mar;62(3):149-55. doi: 10.1055/s-2007-996182.

Abstract

The concept of the minimal clinically important difference (MCID) is intended to provide a measure of relevance for a statistically applied in patients with COPD. Clinically important differences are those differences relevant to the individual patient and important to the patient's life. However, people's difference in a diagnostic parameter perception of what is important vary. Furthermore, physicians may rate the significance of a particular marker and its difference which can be achieved by a pharmacological intervention differently from the patient. Thus, the major problem with defining an MCID for any measure is that the most important differences, which require the most subtle measures for an individual patient, are likely to have the least general application. Conversely, measures that can be generalised are unlikely to have much individual importance and will be very crude tools for an individual assessment. In medical trials both, statistical rigor and clinical relevance are generally required, and MCID is without doubt a key application tool defining treatment success or treatment failure. This paper gives an update on the concept of a minimal important difference of most relevant parameters in COPD treatment.

摘要

最小临床重要差异(MCID)的概念旨在为慢性阻塞性肺疾病(COPD)患者统计学应用提供相关性衡量标准。临床重要差异是指与个体患者相关且对患者生活重要的差异。然而,人们对什么是重要的诊断参数认知存在差异。此外,医生对特定标志物及其通过药物干预可实现的差异的重要性评分可能与患者不同。因此,为任何测量定义MCID的主要问题在于,对个体患者而言最重要的差异,可能需要最精细的测量,但普遍适用性最低。相反,可推广的测量不太可能对个体具有重要意义,并且对于个体评估来说是非常粗略的工具。在医学试验中,通常需要统计严谨性和临床相关性,而MCID无疑是定义治疗成功或失败的关键应用工具。本文对COPD治疗中最相关参数的最小重要差异概念进行了更新。

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