Department of Physical Therapy, Center for Pain Research and Behavioral Health, PO Box 100154, University of Florida, Gainesville, Florida 32611-0154, USA.
J Pain. 2010 Nov;11(11):1074-82. doi: 10.1016/j.jpain.2010.02.016. Epub 2010 May 13.
The equivalency of behavioral interventions has led to the consideration of whether patient-related factors influence clinical trial outcomes. The primary purpose of this secondary analysis was to determine if treatment preference and patient expectation were predictors of trial outcomes and if selected patient-satisfaction items were appropriate as outcome measures. Perceived effectiveness, treatment preference, and patient expectation were assessed before random assignment, and patient satisfaction was assessed 6 months later. Patient preference was associated with perceived effectiveness for those with no treatment preference and those preferring graded exposure. Higher patient expectation was associated with higher perceived effectiveness ratings for all treatments in the clinical trial. Patients with no strong treatment preferences had larger 6-month improvements in pain intensity and disability, while patients with higher expectations had lower disability at baseline, 4 weeks, and 6 months. Patient satisfaction rates did not differ based on treatment received. Patient satisfaction was highest with treatment delivery and much lower with treatment effect. Patient satisfaction was uniformly associated with expectations being met, but only satisfaction with treatment effect was associated with lower pain and disability scores. These data support assessment of treatment preference and patient expectation as predictors and patient satisfaction as an outcome measure in low back pain (LBP) clinical trials.
These data indicate treatment preference potentially impacts rate of improvement for patients with low back pain. Patient expectation did not impact rate of improvement, but those with higher expectations had lower pain and disability scores throughout the trial. Optimal assessment of patient satisfaction should include items that separately consider treatment delivery and effect.
行为干预的等效性导致了对患者相关因素是否影响临床试验结果的考虑。本次二次分析的主要目的是确定治疗偏好和患者期望是否可以预测试验结果,以及是否可以将某些患者满意度项目作为适当的结果衡量指标。在随机分组之前评估了治疗效果、治疗偏好和患者期望,6 个月后评估了患者满意度。对于没有治疗偏好和喜欢分级暴露的患者,治疗偏好与治疗效果相关。在临床试验中,所有治疗方法中,患者期望越高,治疗效果的评分越高。没有强烈治疗偏好的患者在疼痛强度和残疾方面的 6 个月改善程度更大,而期望较高的患者在基线、4 周和 6 个月时的残疾程度更低。患者满意度与治疗方法无关。患者对治疗的满意度最高,对治疗效果的满意度最低。患者满意度与期望的满足程度呈一致相关,但只有对治疗效果的满意度与较低的疼痛和残疾评分相关。这些数据支持在腰痛(LBP)临床试验中评估治疗偏好和患者期望作为预测指标和患者满意度作为结果衡量指标。
这些数据表明,对于腰痛患者,治疗偏好可能会影响其改善率。患者期望不会影响改善率,但在整个试验过程中,期望较高的患者疼痛和残疾评分较低。最佳的患者满意度评估应包括分别考虑治疗效果和治疗效果的项目。