Measuring Clinically Meaningful Change in Outcomes for Youth With Chronic Pain Following Graded Exposure Treatment

Introduction: Functional improvement is a critical outcome for individuals living with chronic pain. Graded exposure treatment (GET) has been associated with statistically significant improvements in functional outcomes for youth with chronic pain by targeting pain-related fear and avoidance. Objective: The aim of the present study was to explore clinically meaningful change in outcomes in adolescents with chronic pain following participation in a GET, and to then classify patients as treatment responders versus nonresponders. Materials and Methods: Participants included 27 youth (M (age)=13.5) with chronic pain enrolled in a recently published single-arm randomized baseline trial of GET Living. Reliable change at the individual level was assessed using the Reliable Change Index (RCI). Adolescents were classified as treatment responders if they achieved a reliable change in outcomes across time points and also demonstrated a change in clinical severity range in the expected direction (ie, from severe to moderate). Results: Reliable and clinically significant improvements in pain-related fear and avoidance, functional disability, and school functioning were demonstrated at discharge, with improvements maintained at 3-month and 6-month follow-up. Among core outcomes, 48% (n=13) of patients were classified as treatment responders in one or more outcomes at discharge, with this increasing to 76% (n=19) at 3-month follow-up. Discussion: Examining reliable and clinically meaningful change (vs. statistical significance alone) provides a way to examine treatment response to an intervention and to enhance the interpretability of findings, helping to bridge the gap between clinical trials and clinical practice by providing guidelines for interpretation.