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논문KCI 등재

뇌졸중 임상시험에서 치료결과의 측정 및 효과 판정

Outcome Measure and Efficacy Analysis in Stroke Clinical Trials

홍근식
대한신경과학회 (Korean Neurological Association)|2006.10|대한신경과학회지 (Journal of the Korean Neurological Association)|제24권 제5호|pp. 411-420

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참고문헌

주제분류신경과학

초록

Abstract

In clinical trials, treatment response should be assessed with appropriate outcome measure and analytic methods. Selection of outcome measure is dependent on the characteristics of subjects and given therapy. For stroke prevention trials, the usual outcome measure is the composite of clinical events such as non-fatal stroke, non-fatal myocardial infarction, or vascular death. On the other hand, for acute stroke trials, stroke severity and functional outcome are essential outcome measures. Neuroimaging is an emerging tool of outcome measure as well as a means of optimizing patient selection in stroke trials. For the analysis of therapeutic efficacy, measured outcomes were usually dichotomized to “good” or “bad” according to arbitrary criteria. Although this approach makes the result of clinical trials easy to interpret, it may have the great chance of missing the clinically important, but modest therapeutic efficacy. To overcome this disadvantage, new analytic strategies such as sliding dichotomy and shift analysis have been proposed. Understanding of outcome measures and analytic methods is important to interpret or design the stroke clinical trials.

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