APPROACHES TO THE ANALYSIS OF QUALITY-OF-LIFE DATA - EXPERIENCES GAINED FROM MEDICAL-RESEARCH-COUNCIL LUNG-CANCER WORKING PARTY PALLIATIVE CHEMOTHERAPY TRIAL
APPROACHES TO THE ANALYSIS OF QUALITY-OF-LIFE DATA - EXPERIENCES GAINED FROM MEDICAL-RESEARCH-COUNCIL LUNG-CANCER WORKING PARTY PALLIATIVE CHEMOTHERAPY TRIAL
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DOI：
10.1007/bf00451726
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发表时间：
1994-10-01
影响因子：
3.5
通讯作者：
MACHIN, D
中科院分区：
文献类型：
--
作者：
HOPWOOD, P;STEPHENS, RJ;MACHIN, D
生活质量（QOL）评估工具的质量选择标准化及其在随机临床试验中的应用已得到倡导并被普遍接受。然而，现在迫切需要解决与分析和呈现由此产生的数据相关的问题。生活质量数据存在内在困难，即其多维性质、数据缺失和损耗，并且对于应如何处理这些问题没有达成共识。因此，本文利用医学研究委员会一项针对小细胞肺癌且预后不良患者的大型随机试验的中期数据来考虑这些问题，在该试验中，数据损耗和依从性是主要关注点。详细研究了使用不同患者子集分析这些数据的三种可能方法。讨论了这三种方法的优缺点，给出了它们在文献中的使用实例，并与其他报道的方法进行了比较。还强调了对依从性进行标准定义的必要性，并提出了一种呈现方法。目前最好的建议是，应以多种不同方式分析生活质量数据，并且只有当结果一致时才能得出结论。
Standardization in the choice of quality of life (QOL) instruments and their application in randomised clinical trials have been advocated and generally accepted. However, there is now an urgent need to address the problems relating to the analysis and presentation of the data thus generated. There are intrinsic difficulties associated with QOL data, namely its multidimensional nature, attrition and missing data, and there is no consensus as to how these problems should be dealth with. This paper therefore considers these problems using interim data from a large Medical Research Council randomised trial in patients with small cell lung cancer and a poor prognosis, in which attrition and compliance are major concerns. Three possible approaches to the analysis of these data, which use different subsets of patients, are examined in detail. The strengths and weaknesses of these three methods are discussed, and examples of their use in the literature are given and compared with other reported approaches. The need for a standard definition of compliance is also emphasised, and a method of presentation suggested. The best current advice is that QOL data should be analysed in a number of different ways, and conclusions reached only when consistency is seen.