Introducing economic and quality of life measurements into clinical studies
Introducing economic and quality of life measurements into clinical studies
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DOI：
10.3109/07853890109002088
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发表时间：
2001-07-01
影响因子：
4.4
通讯作者：
Drummond, M
中科院分区：
文献类型：
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作者：
Drummond, M
虽然成本和生活质量数据的收集与临床研究一起及时产生了详细的患者水平数据，但它也提出了实践和方法上的挑战。这些因素包括：参加试验的环境和患者可能不是常规临床实践中发现的典型情况，费用和生活质量可能受到试验方案的影响，试验中比较的临床备选方案可能与成本-效果评估不是最相关的，随访时间可能太短，无法观察费用和生活质量的变化，以及添加这些数据将增加试验中的总体测量负担。本文讨论了这些挑战和克服它们的方法，尤其是基于偏好的生活质量测量，对多国研究中生活质量量表的选择范围、生活质量测量的样本量计算以及生活质量的测量提出了建议。
Although the collection of cost and quality of life data alongside clinical studies generates detailed patient level data in a timely fashion, it also raises practical and methodological challenges. These include the fact that the settings and patients enrolled in trials may not be typical of those found in regular clinical practice, that costs and quality of life may be influenced by the trial protocol, that the clinical alternatives compared in trials may not be the most relevant for cost-effectiveness assessments, that the length of follow-up may be too short to observe changes in cost and quality of life, and that adding these data will increase the overall measurement burden in the trial, This paper discusses these challenges and the ways in which they might be overcome, focussing particularly on preference-based measures of quality of life, In particular, recommendations are given for choosing the range of quality of life instruments, sample size calculations for quality of life measurement and the measurement of quality of life in multinational studies.