Systematic Review: Issues in Measuring Clinically Meaningful Change in Self-Reported Chronic Pediatric Pain Intensity.

OBJECTIVE This report examined limitations in our ability to assess clinically significant change (CSC) in randomized controlled trials of treatments of self-reported pediatric chronic pain intensity. METHODS The following were reviewed: (a) approaches to assessing CSC; (b) approaches to assessing CSC used in psychological treatment studies of self-reported pediatric chronic pain intensity included in a recent systematic review; (c) the role of test-retest reliability in distribution-based CSC measures; (d) the test-retest reliability of recommended chronic pain measures. RESULTS AND CONCLUSIONS Existing studies do not assess whether a CSC occurred or use procedures that did not account for measurement error and true score fluctuations unrelated to treatment, possibly resulting in overestimating CSCs. Distribution-based approaches to assessing CSCs that address these problems require knowing test-retest reliability of the chronic pain measure at appropriate intervals. Available information raises concern about our ability to estimate CSC reliably. Recommendations are made for future research.