Weinfurt Kevin P, Trucco Sara M, Willke Richard J, Schulman Kevin A
Center for Clinical and Genetic Economics, Duke Clinical Research Institute, Duke University Medical Center, Durham, NC 17969-27715, USA.
J Clin Epidemiol. 2002 Jun;55(6):608-18. doi: 10.1016/s0895-4356(02)00392-x.
When patients cannot provide responses to health-related quality-of-life (HRQOL) measures in clinical trials, family or friends may be asked to respond. We present a simple, comprehensive method for assessing agreement between patients with head injury and their proxy responders. In contrast to more traditional approaches, this method defines agreement separately for each patient-proxy pair, and compares HRQOL profiles along three dimensions-level, or the average of the ratings; scatter, or the variability in the ratings; and shape, or the ranks of the ratings. We demonstrate this method in the context of a clinical trial of a treatment for traumatic head injury and compare the results to those obtained using traditional analyses. Options for incorporating proxy responses into clinical trial analyses are discussed.
在临床试验中，当患者无法对健康相关生活质量（HRQOL）测量做出回应时，可能会要求家人或朋友代为回应。我们提出了一种简单、全面的方法，用于评估头部受伤患者与其代理回应者之间的一致性。与更传统的方法不同，该方法为每对患者-代理单独定义一致性，并沿三个维度——水平（即评分的平均值）、离散度（即评分的变异性）和形状（即评分的排名）比较HRQOL概况。我们在一项创伤性脑损伤治疗的临床试验背景下演示了该方法，并将结果与使用传统分析方法获得的结果进行比较。还讨论了将代理回应纳入临床试验分析的选项。
