评估脑卒中康复结局测量中的脑卒中特异性生活质量：最小有意义变化和临床有意义差异。
Assessing the stroke-specific quality of life for outcome measurement in stroke rehabilitation: minimal detectable change and clinically important difference.
机构信息
Department of Occupational Therapy, College of Medicine, National Taiwan University, and Department of Physical Medicine and Rehabilitation, National Taiwan University Hospital, Taipei, Taiwan.
出版信息
Health Qual Life Outcomes. 2011 Jan 19;9:5. doi: 10.1186/1477-7525-9-5.
BACKGROUND
This study was conducted to establish the minimal detectable change (MDC) and clinically important differences (CIDs) of the physical category of the Stroke-Specific Quality of Life Scale in patients with stroke.
METHODS
MDC and CIDs scores were calculated from the data of 74 participants enrolled in randomized controlled trials investigating the effects of two rehabilitation programs in patients with stroke. These participants received treatments for 3 weeks and underwent clinical assessment before and after treatment. To obtain test-retest reliability for calculating MDC, another 25 patients with chronic stroke were recruited. The MDC was calculated from the standard error of measurement (SEM) to indicate a real change with 95% confidence for individual patients (MDC95). Distribution-based and anchor-based methods were adopted to triangulate the ranges of minimal CIDs. The percentage of scale width was calculated by dividing the MDC and CIDs by the total score range of each physical category. The percentage of patients exceeding MDC95 and minimal CIDs was also reported.
RESULTS
The MDC95 of the mobility, self-care, and upper extremity (UE) function subscales were 5.9, 4.0, and 5.3 respectively. The minimal CID ranges for these 3 subscales were 1.5 to 2.4, 1.2 to 1.9, and 1.2 to 1.8. The percentage of patients exceeding MDC95 and minimal CIDs of the mobility, self-care, and UE function subscales were 9.5% to 28.4%, 6.8% to 28.4%, and 12.2% to 33.8%, respectively.
CONCLUSIONS
The change score of an individual patient has to reach 5.9, 4.0, and 5.3 on the 3 subscales to indicate a true change. The mean change scores of a group of patients with stroke on these subscales should reach the lower bound of CID ranges of 1.5 (6.3% scale width), 1.2 (6.0% scale width), and 1.2 (6.0% scale width) to be regarded as clinically important change. This information may facilitate interpretations of patient-reported outcomes after stroke rehabilitation. Future research is warranted to validate these findings.
背景
本研究旨在确定脑卒中患者脑卒中特异性生活质量量表（SS-QOL）身体状况部分的最小可检测变化（MDC）和临床重要差异（CIDs）。
方法
从 74 名参加两项康复计划随机对照试验的患者数据中计算 MDC 和 CIDs 评分。这些参与者接受了 3 周的治疗，并在治疗前后进行了临床评估。为了获得用于计算 MDC 的测试-重测信度，又招募了 25 名慢性脑卒中患者。MDC 是从测量标准误差（SEM）中计算出来的，以表示个体患者 95%置信区间的真实变化（MDC95）。采用基于分布和基于锚定的方法来确定最小 CIDs 的范围。通过将 MDC 和 CIDs 除以每个身体状况部分的总分范围来计算量表宽度的百分比。还报告了超过 MDC95 和最小 CIDs 的患者比例。
结果
移动、自理和上肢（UE）功能子量表的 MDC95 分别为 5.9、4.0 和 5.3。这 3 个子量表的最小 CID 范围分别为 1.5 至 2.4、1.2 至 1.9 和 1.2 至 1.8。超过 MDC95 和最小 CIDs 的移动、自理和 UE 功能子量表的患者比例分别为 9.5%至 28.4%、6.8%至 28.4%和 12.2%至 33.8%。
结论
个体患者的变化得分必须达到 3 个子量表的 5.9、4.0 和 5.3，才能表明发生了真正的变化。脑卒中患者这些子量表的平均变化得分应达到 CID 范围下限 1.5（6.0%量表宽度）、1.2（6.0%量表宽度）和 1.2（6.0%量表宽度），才能被认为是具有临床意义的变化。这些信息可能有助于解释脑卒中康复后的患者报告结局。需要进一步的研究来验证这些发现。
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