Assessment of pain intensity in clinical trials: Individual ratings vs composite scores

Abstract

Objectives: To evaluate the reliability of findings suggesting that composite scores made up of just two ratings of recalled pain may be adequately reliable and valid for assessing outcome in pain clinical trials. Design: Secondary analyses of data from a study where the responsivity of the outcome measures was a critical concern; that is, a study with few subjects testing the effects of a treatment that had only modest effects. Ten adults with spinal cord injury rated four domains of pain intensity (current pain and 24-hour recalled worst, least, and average pain) on four occasions before and after 12 sessions of neurofeedback treatment. We evaluated the reliability and validity of four single ratings and 16 different composite scores. Results: None of the single-item scales performed adequately. However, composite scores made up of two items or more yielded consistent effect size estimates. Conclusions: The findings provide additional evidence that two-item composite scores may be adequate for assessing the primary outcome of pain intensity in chronic pain clinical trials. Additional research is needed to further establish the generalizability of these findings.