Measuring agreement between patient and proxy responses to multidimensional health-related quality-of-life measures in clinical trials. An application of psychometric profile analysis.

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.

Duke Scholars

Author Kevin Phillip Weinfurt Population Health Sciences