用于评估与慢性肾病相关贫血患者的简明健康调查问卷（SF-36）和癌症治疗功能评估-贫血量表（FACT-An）的测量性能。
Measurement properties of the Short Form-36 (SF-36) and the Functional Assessment of Cancer Therapy - Anemia (FACT-An) in patients with anemia associated with chronic kidney disease.
机构信息
Yale University, New Haven, CT, USA.
Formerly with Astellas Pharma BV, Sylviusweg 62, 2333, BE, Leiden, The Netherlands.
出版信息
Health Qual Life Outcomes. 2018 May 31;16(1):111. doi: 10.1186/s12955-018-0933-8.
BACKGROUND
Anemia is a common and debilitating manifestation of chronic kidney disease (CKD). Data from two clinical trials in patients with anemia of CKD were used to assess the measurement properties of the Medical Outcomes Survey Short Form-36 version 2 (hereafter SF-36) and the Functional Assessment of Cancer Therapy-Anemia (FACT-An). The Vitality and Physical functioning domains of the SF-36 and the FACT-An Total, Fatigue and Anemia subscales were identified as domains relevant to CKD-associated anemia.
METHODS
A total of 204 patients aged 18-80 years were included in the analyses that included internal consistency (Cronbach's alpha), test-retest reliability (intraclass correlation coefficients [ICCs]), convergent and known-groups validity, responsiveness, and estimates of important change.
RESULTS
Both the SF-36 and the FACT-An had strong psychometric properties with high internal consistency (Cronbach's alpha: 0.69-0.93 and 0.79-0.95), and test-retest reliability (ICCs: 0.64-0.83 and 0.72-0.88). Convergent validity, measured by correlation coefficients between similar concepts in SF-36 and FACT-An, ranged from 0.52 to 0.77. Correlations with hemoglobin (Hb) levels were modest at baseline; by Week 9, the correlations with Hb were somewhat higher, r = 0.23 (p < 0.05) for SF-36 Vitality, r = 0.22 (p < 0.05) for FACT-An Total, r = 0.26 (p < 0.001) for FACT-Fatigue and r = 0.22 (p < 0.01) for Anemia. Correlations with Hb at Week 13/17 were r = 0.28 (p < 0.001) for SF-36 Vitality and r = 0.25 (p < 0.05) for Role Physical; FACT-An Total correlation was r = 0.33 (p < 0.0001), Anemia was r = 0.28 (p < 0.001), and Fatigue was r = 0.30 (p < 0.001). The SF-36 domains and Component Summary scores (p < 0.05-p < 0.0001) demonstrated ability to detect change. For the FACT-An, significant differences (p < 0.05-p < 0.0001) were observed between responder and non-responder change scores: important change score estimates ranged from 2 to 4 for Vitality and 2-3 for Physical functioning. Important change scores were also estimated for the FACT-An Total score (6-9), the Anemia (3-5), and Fatigue subscale (2-4).
CONCLUSIONS
Both the SF-36 Vitality and Physical function scales and the FACT-An Total, Fatigue and Anemia scales, are reliable and valid measures for assessing health-related quality of life in anemia associated with CKD.
背景
贫血是慢性肾脏病（CKD）的常见且使人虚弱的表现。来自两项针对 CKD 贫血患者的临床试验的数据用于评估医疗结局调查简表 36 版（以下简称 SF-36）和癌症治疗功能评估-贫血（FACT-An）的测量特性。SF-36 的活力和身体功能域以及 FACT-An 的总评分、疲劳和贫血子量表被确定为与 CKD 相关贫血相关的域。
方法
共纳入 204 名年龄在 18-80 岁的患者进行分析，包括内部一致性（Cronbach's alpha）、重测信度（组内相关系数[ICC]）、收敛和已知组有效性、反应性以及重要变化的估计值。
结果
SF-36 和 FACT-An 均具有很强的心理测量特性，具有较高的内部一致性（Cronbach's alpha：0.69-0.93 和 0.79-0.95）和重测信度（ICC：0.64-0.83 和 0.72-0.88）。相似概念之间的收敛有效性，通过 SF-36 和 FACT-An 之间的相关系数来衡量，范围从 0.52 到 0.77。与血红蛋白（Hb）水平的相关性在基线时较低；到第 9 周，与 Hb 的相关性略高，SF-36 活力的相关性为 r=0.23（p<0.05），FACT-An 总评分的相关性为 r=0.22（p<0.05），FACT-Fatigue 的相关性为 r=0.26（p<0.001），贫血的相关性为 r=0.22（p<0.01）。第 13/17 周时与 Hb 的相关性为 SF-36 活力的 r=0.28（p<0.001）和 Role Physical 的 r=0.25（p<0.05）；FACT-An 总评分的相关性为 r=0.33（p<0.0001），贫血的相关性为 r=0.28（p<0.001），疲劳的相关性为 r=0.30（p<0.001）。SF-36 各域和成分总结评分（p<0.05-p<0.0001）均能检测到变化。对于 FACT-An，反应者和非反应者变化评分之间存在显著差异（p<0.05-p<0.0001）：活力和身体功能的重要变化评分估计值范围为 2 到 4，物理功能为 2 到 3。FACT-An 总评分（6-9）、贫血（3-5）和疲劳子量表（2-4）也估计了重要变化评分。
结论
SF-36 活力和身体功能量表以及 FACT-An 总评分、疲劳和贫血量表均为可靠有效的工具，可用于评估与 CKD 相关贫血的健康相关生活质量。
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