Gotay C C
University of Hawaii Cancer Research Center, Honolulu 96813, USA.
J Natl Cancer Inst Monogr. 1996(20):1-6.
Issues in selecting quality-of-life (QOL) measures that are best suited to assessing differences among treatments in cancer clinical trials, as well as challenges to interpreting QOL outcome data, are discussed. When used in the context of randomized trials of cancer therapies, QOL assessments must provide an answer to the question, "Did the treatments differentially affect patient well-being?" In order to detect differences in treatment efficacy against a background of great similarity, the broad concept of QOL needs to be refined to reflect "trial-related QOL." In many cases, this will entail emphasis on actual patient experience of symptoms and functional changes, as opposed to emphasis solely on evaluation and satisfaction. A model is proposed to identify cognitive, emotional, and sociocultural factors that influence a patient's QOL evaluation and that need to be considered in understanding the meaning of QOL data.
讨论了在癌症临床试验中选择最适合评估不同治疗方法之间差异的生活质量（QOL）测量方法的问题，以及解释QOL结果数据所面临的挑战。当在癌症治疗的随机试验背景下使用时，QOL评估必须回答“这些治疗方法对患者幸福感的影响是否存在差异？”这个问题。为了在高度相似的背景下检测治疗效果的差异，需要对QOL的宽泛概念进行细化，以反映“与试验相关的QOL”。在许多情况下，这将需要强调患者对症状和功能变化的实际体验，而不是仅仅强调评估和满意度。提出了一个模型，以识别影响患者QOL评估的认知、情感和社会文化因素，这些因素在理解QOL数据的意义时需要加以考虑。
