Department of Anesthesiology, Perioperative & Pain Medicine, Stanford University School of Medicine, Stanford, California.
Department of Anesthesiology, Perioperative & Pain Medicine, Stanford University School of Medicine, Stanford, California.
J Pain. 2022 Jan;23(1):55-64. doi: 10.1016/j.jpain.2021.06.009. Epub 2021 Jul 3.
Patient Reported Outcomes (PROs) are utilized in clinical registries and trials, necessitating development of benchmarks to enhance interpretability. This study aimed to 1) examine if PROMIS measures administered via computer adaptive testing (CAT) were responsive to change, and 2) highlight one method of assessing clinically significant change for youth seen in a tertiary pain clinic. Clinically significant change was achieved if patients had significantly reliable pre-to-post-changes greater than Reliable Change Index (RCI) value and reported decreased symptoms by at least one severity level (e.g., moderate to mild). Participants were 328 youth (8-17 years old) seen in a tertiary pediatric pain management clinic. Small to moderate effect sizes were noted across PROMIS measures (except Peer Relations). Reliable magnitudes of change were estimated for this sample as approximately 6 point reduction for Pain Interference and Mobility, 9 for Fatigue, and 11 for Anxiety and Depression. Depending on the measure, 10 to 24% were categorized as improved, 3 to 6% as deteriorated, and 68 to 81% were either not clinically elevated at baseline or remained unchanged at 3 months. Overall, PROMIS CAT measures demonstrated responsiveness to change over time. Estimation of clinically significant change offers preliminary yet rigorous benchmarks for evaluating treatment response and sets the stage for understanding treatment effects. PERSPECTIVE: This study assesses responsiveness of CAT administered PROMIS measures and highlights one methodological approach of presenting clinical significance for assessing treatment outcomes in pediatric chronic pain. These benchmarks will allow clinicians and researchers to evaluate treatment response utilizing PROs while allowing for a deeper understanding of treatment effects.
患者报告的结局（PROs）在临床登记和试验中得到了应用，这就需要制定基准来提高可解释性。本研究旨在：1）考察通过计算机自适应测试（CAT）进行的 PROMIS 测量是否对变化有反应，2）强调一种评估在三级疼痛诊所就诊的青少年的临床显著变化的方法。如果患者的前后变化具有显著的可靠性，且大于可靠变化指数（RCI）值，并且报告的症状至少降低了一个严重程度级别（例如，从中度到轻度），则认为达到了临床显著变化。参与者为 328 名在三级儿科疼痛管理诊所就诊的青少年（8-17 岁）。PROMIS 测量（同伴关系除外）均显示出小到中等的效应量。对于这个样本，可靠的变化幅度估计为疼痛干扰和移动性减少约 6 点，疲劳减少 9 点，焦虑和抑郁减少 11 点。根据测量方法的不同，10%至 24%的患者被归类为改善，3%至 6%的患者被归类为恶化，68%至 81%的患者在基线时没有临床显著升高或在 3 个月时没有变化。总体而言，PROMIS CAT 测量随着时间的推移显示出对变化的反应性。临床显著变化的估计为评估治疗反应提供了初步但严格的基准，并为理解治疗效果奠定了基础。观点：本研究评估了 CAT 管理的 PROMIS 测量的反应性，并强调了一种评估儿童慢性疼痛治疗结果的临床意义的方法。这些基准将使临床医生和研究人员能够利用 PROs 评估治疗反应，同时更深入地了解治疗效果。
