Measuring Clinically Meaningful Change in Outcomes for Youth With Chronic Pain Following Graded Exposure Treatment.
Measuring Clinically Meaningful Change in Outcomes for Youth With Chronic Pain Following Graded Exposure Treatment.
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DOI：
10.1097/ajp.0000000000001031
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发表时间：
2022-03-10
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功能改善是慢性疼痛患者的关键结果。分级暴露治疗通过针对疼痛相关的恐惧和回避，与慢性疼痛青年的功能结局的统计学显著改善相关。本研究的目的是探讨青少年慢性疼痛患者在参与分级暴露治疗（GET Living）后结局的临床意义变化，然后将患者分类为治疗应答者与非应答者。参与者包括27名患有慢性疼痛的青年（法师= 13.5），他们参加了最近发表的GET Living单臂随机基线试验。使用可靠变化指数（RCI）评估个体水平的可靠变化。如果青少年在不同时间点的结局发生可靠变化，并且临床严重程度范围在预期方向上发生变化（即，从严重到中度）。出院时，疼痛相关的恐惧和回避、功能障碍和学校功能得到了可靠和临床显著的改善，并在3个月和6个月随访时保持了改善。在核心结局中，48%（n=13）的患者在出院时的一个或多个结局中被归类为治疗应答者，在3个月随访时增加至76%（n=19）。检查可靠且有临床意义的变化（与单独的统计学显著性相比）提供了一种检查干预治疗反应的方法，并增强了结果的可解释性，通过提供解释指南，有助于弥合临床试验和临床实践之间的差距。
Functional improvement is a critical outcome for individuals living with chronic pain. Graded exposure treatment has been associated with statistically significant improvements in functional outcomes for youth with chronic pain by targeting pain-related fear and avoidance. The aim of the present study was to explore clinically meaningful change in outcomes in adolescents with chronic pain following participation in a graded exposure treatment (GET Living), and to then classify patients as treatment responders vs non-responders. Participants included 27 youth (Mage = 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 (i.e., from severe to moderate). 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. 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.