Stucki G, Liang M H, Fossel A H, Katz J N
Department of Rheumatology and Physical Medicine, University Hospital Zurich, University of Zurich, Switzerland.
J Clin Epidemiol. 1995 Nov;48(11):1369-78. doi: 10.1016/0895-4356(95)00054-2.
The objective of this study was to compare the relative responsiveness of a condition-specific spinal stenosis measure and two generic health status measures for outcome assessment of surgery for degenerative lumbar spinal stenosis, and to examine whether responsiveness statistics and measures of the ability to distinguish clinically important improvement rank the instruments consistently. Physical function and symptom severity scales of the spinal stenosis measure were compared to the Sickness Impact Profile (SIP) and the Roland scale, which is derived from the SIP. Responsiveness was calculated with the standardized response mean, the effect size, and Guyatt's responsiveness statistic. The discriminative ability of the instruments to distinguish patients who improved from those who did not was assessed using satisfaction with surgery as an external criterion. Minimal clinically relevant improvement was estimated using patient satisfaction as the external criterion. All responsiveness statistics revealed the same order of responsiveness; the physical function scale (SRM = 1.07) and symptom severity scales (SRM = 0.96) were more responsive than the Roland scale (SRM = 0.77) which was only slightly more responsive than the SIP (SRM = 0.69). Strikingly, the physical dimension of the SIP (SRM = 0.62) was even less responsive than the global SIP. The shape of and the area under the ROC curves showed that the physical function and symptom severity scales discriminate better between satisfied and unsatisfied patients than the Roland scale and SIP. The sensitivity to detect clinically important changes was somewhat lower at the ends of the scales, especially for the SIP and the Roland scale. Statistical approaches that assess the ability to distinguish clinically important changes and overall responsiveness statistics ranked the measures consistently. On the basis of these findings, we suggest that a condition-specific spinal stenosis measure is preferable as the primary end point in evaluative studies of degenerative lumbar spinal stenosis.
本研究的目的是比较一种针对特定病情的腰椎管狭窄症测量方法与两种通用健康状况测量方法，以评估退行性腰椎管狭窄症手术的疗效，并检验反应性统计数据和区分临床重要改善能力的测量方法是否对这些工具给出一致的排名。将腰椎管狭窄症测量方法的身体功能和症状严重程度量表与疾病影响量表（SIP）以及源自SIP的罗兰量表进行比较。使用标准化反应均值、效应量和盖亚特反应性统计量来计算反应性。以对手术的满意度作为外部标准，评估这些工具区分改善患者和未改善患者的鉴别能力。以患者满意度作为外部标准，估计最小临床相关改善情况。所有反应性统计数据都显示出相同的反应性顺序；身体功能量表（标准化反应均值=1.07）和症状严重程度量表（标准化反应均值=0.96）比罗兰量表（标准化反应均值=0.77）反应性更强，而罗兰量表仅比SIP（标准化反应均值=0.69）稍具反应性。引人注目的是，SIP的身体维度（标准化反应均值=0.62）甚至比整体SIP反应性更低。ROC曲线的形状和曲线下面积表明，身体功能和症状严重程度量表在区分满意和不满意患者方面比罗兰量表和SIP更好。在量表两端检测临床重要变化的敏感性略低，尤其是对于SIP和罗兰量表。评估区分临床重要变化能力的统计方法和整体反应性统计数据对这些测量方法给出了一致的排名。基于这些发现，我们建议在退行性腰椎管狭窄症的评估研究中，采用针对特定病情的腰椎管狭窄症测量方法作为主要终点更为可取。
