Machin D
Medical Research Council, Cancer Trials Office, Cambridge, U.K.
J Natl Cancer Inst Monogr. 1996(20):97-102.
This article describes aspects of the way the Cancer Therapy Committee of the British Medical Research Council incorporates quality-of-life (QOL) assessments in randomized clinical trials in patients with cancer. The steps taken in incorporating QOL assessments in individual trial protocols are described. The aspects described concern problems associated with choice of instruments, time of assessment, sample size, and analysis. A protocol for patients with small-cell lung cancer that compares oral etoposide with intravenous multidrug chemotherapy is used for illustration.
本文描述了英国医学研究委员会癌症治疗委员会在癌症患者随机临床试验中纳入生活质量（QOL）评估的方式。文中阐述了在各个试验方案中纳入QOL评估所采取的步骤。所描述的方面涉及与评估工具选择、评估时间、样本量和分析相关的问题。以一项比较口服依托泊苷与静脉多药化疗的小细胞肺癌患者试验方案为例进行说明。
