Department of Physical Medicine and Rehabilitation, University of Michigan Medical School, Ann Arbor, MI.
Department of Physical Medicine and Rehabilitation, University of Michigan Medical School, Ann Arbor, MI.
Arch Phys Med Rehabil. 2015 Feb;96(2):340-8. doi: 10.1016/j.apmr.2014.09.036. Epub 2014 Oct 22.
To assess the role that treatment response plays in a randomized controlled trial of an antidepressant among people with spinal cord injury (SCI) diagnosed with major depressive disorder (MDD) in explaining quality of life (QOL), assessed both globally as life satisfaction and in terms of physical and mental health-related QOL.
Multivariable analyses were conducted, controlling for demographic, neurologic, and participatory factors and perceived functional limitations.
Rehabilitation centers.
Of the 133 persons who were randomized into the Project to Improve Symptoms and Mood after Spinal Cord Injury randomized controlled trial, 124 participated in this study. All participants were between the ages of 18 and 64 years, at least 1 month post-SCI, met the Diagnostic and Statistical Manual of Mental Disorders, 4th edition, criteria for MDD, and completed the core measures used in this study.
Not applicable.
The Satisfaction with Life Scale and the physical and mental component summary scores of the Medical Outcomes Study 12-Item Short-Form Health Survey.
Reduction in depressive symptoms over the course of a 12-week trial was predictive of increased QOL, which was measured as life satisfaction and mental well-being, within the context of other explanatory factors. However, reduction in symptoms did not explain differences in physical well-being among those with MDD. Perceived functional disability explained all 3 indices of QOL.
Greater recognition has been given to QOL outcomes as endpoints of clinical trials because these often reflect participants' reported outcomes. Our findings support the association of QOL to the reduction of depression symptoms among trial participants. This association differs depending on how QOL is defined and measured, with stronger relations observed with life satisfaction and mental well-being among those diagnosed with MDD. The lack of association between depression and physical well-being may be explained by participants' subjective interpretation of physical well-being after SCI and their expectations and perceptions of improved physical health-related QOL based on the use of assistive technology. Consistent with our findings, pain is likely to play a role in decreasing physical QOL among those with incomplete injuries. Practicing caution is suggested in using physical well-being as an endpoint in trials among people with SCI.
评估治疗反应在一项脊髓损伤（SCI）患者伴重性抑郁障碍（MDD）的抗抑郁药随机对照试验中的作用，该试验用于解释生活质量（QOL），包括总体生活满意度以及身心健康相关 QOL。
进行多变量分析，控制人口统计学、神经学和参与因素以及感知功能限制。
康复中心。
在改善脊髓损伤后症状和情绪的项目中随机分为 133 人的 124 人参加了这项研究。所有参与者年龄在 18 至 64 岁之间，SCI 后至少 1 个月，符合精神障碍诊断与统计手册，第 4 版，MDD 标准，并完成了本研究中使用的核心措施。
不适用。
生活满意度量表和医疗结果研究 12 项简短健康调查的身体和心理成分综合评分。
在 12 周试验过程中，抑郁症状的减轻可预测 QOL 的增加，这是在其他解释因素的背景下测量的生活满意度和心理健康。然而，症状的减轻并不能解释 MDD 患者身体幸福感的差异。感知功能障碍解释了所有 3 个 QOL 指标。
人们越来越重视生活质量作为临床试验的终点，因为这些终点通常反映了参与者的报告结果。我们的发现支持 QOL 与试验参与者抑郁症状减轻的关联。这种关联取决于 QOL 的定义和测量方式，在 MDD 诊断患者中，生活满意度和心理健康的关联更强。抑郁与身体健康之间缺乏关联可能是由于参与者对 SCI 后身体幸福感的主观解释，以及他们对使用辅助技术改善身心健康相关 QOL 的期望和看法。与我们的发现一致，疼痛可能会降低不完全损伤患者的身体 QOL。建议在 SCI 患者的试验中谨慎使用身体幸福感作为终点。
