Cella David, Lai Jin-Shei, Jensen Sally E, Christodoulou Christopher, Junghaenel Doerte U, Reeve Bryce B, Stone Arthur A
Department of Medical Social Sciences, Northwestern University Feinberg School of Medicine, 633 N. St. Clair, 19th Floor, Chicago, IL, USA.
Department of Medical Social Sciences, Northwestern University Feinberg School of Medicine, 633 N. St. Clair, 19th Floor, Chicago, IL, USA.
J Clin Epidemiol. 2016 May;73:128-34. doi: 10.1016/j.jclinepi.2015.08.037. Epub 2016 Mar 3.
To evaluate the comparability and responsiveness of Patient-Reported Outcomes Measurement Information System (PROMIS) fatigue item bank across six chronic conditions.
Individuals (n = 1,430) with chronic obstructive pulmonary disease (n = 125), chronic heart failure (n = 60), chronic back pain (n = 218), major depressive disorder (n = 196), rheumatoid arthritis (n = 521), and cancer (n = 310) completed assessments from the PROMIS fatigue item bank at baseline and a clinically relevant follow-up. The cancer and arthritis samples were followed in observational studies; the other four groups were enrolled immediately before a planned clinical intervention. All participants completed global ratings of change at follow-up. Linear mixed-effects models and standardized response means were estimated to examine clinical validity and responsiveness to change.
All patient groups reported more fatigue than the general population (range = 0.2-1.29 standard deviation worse). The four clinical groups with pretreatment baseline data experienced significant improvement in fatigue at follow-up (effect size range = 0.25-0.91). Individuals reporting better overall health usually experienced larger fatigue changes than those reporting worse overall health.
The results support the PROMIS fatigue measures's responsiveness to change in six different chronic conditions. In addition, these results support the ability of the PROMIS fatigue measures to compare differences in fatigue across a range of chronic conditions, thereby enabling comparative effectiveness research.
评估患者报告结局测量信息系统(PROMIS)疲劳条目库在六种慢性病中的可比性和反应性。
患有慢性阻塞性肺疾病(n = 125)、慢性心力衰竭(n = 60)、慢性背痛(n = 218)、重度抑郁症(n = 196)、类风湿性关节炎(n = 521)和癌症(n = 310)的个体(n = 1430)在基线和具有临床意义的随访时完成了PROMIS疲劳条目库的评估。癌症和关节炎样本在观察性研究中进行随访;其他四组在计划的临床干预前立即入组。所有参与者在随访时完成了总体变化评分。估计线性混合效应模型和标准化反应均值以检验临床有效性和对变化的反应性。
所有患者组报告的疲劳程度均高于一般人群(范围 = 比一般人群差0.2 - 1.29个标准差)。有治疗前基线数据的四个临床组在随访时疲劳程度有显著改善(效应量范围 = 0.25 - 0.91)。报告总体健康状况较好的个体通常比报告总体健康状况较差的个体经历更大的疲劳变化。
结果支持PROMIS疲劳测量指标对六种不同慢性病变化的反应性。此外,这些结果支持PROMIS疲劳测量指标在一系列慢性病中比较疲劳差异的能力,从而实现比较疗效研究。