Methods for assessing responsiveness: a critical review and recommendations.

A review of the literature suggests there are two major aspects of responsiveness. We define the first as "internal responsiveness," which characterizes the ability of a measure to change over a prespecified time frame, and the second as "external responsiveness, " which reflects the extent to which change in a measure relates to corresponding change in a reference measure of clinical or health status. The properties and interpretation of commonly used internal and external responsiveness statistics are examined. It is from the interpretation point of view that external responsiveness statistics are considered particularly attractive. The usefulness of regression models for assessing external responsiveness is also highlighted.