Lin Fang-Ju, Pickard A Simon, Krishnan Jerry A, Joo Min J, Au David H, Carson Shannon S, Gillespie Suzanne, Henderson Ashley G, Lindenauer Peter K, McBurnie Mary Ann, Mularski Richard A, Naureckas Edward T, Vollmer William M, Lee Todd A
University of Illinois at Chicago, Chicago, IL, USA.
BMC Med Res Methodol. 2014 Jun 16;14:78. doi: 10.1186/1471-2288-14-78.
The Patient Reported Outcomes Measurement Information System 43-item short form (PROMIS-43) and the five-level EQ-5D (EQ-5D-5L) are recently developed measures of health-related quality of life (HRQL) that have potentially broad application in evaluating treatments and capturing burden of respiratory-related diseases. The aims of this study were: (1) to examine their psychometric properties in patients with chronic obstructive pulmonary disease (COPD), and (2) to identify dimensions of HRQL that differ and do not differ by lung function.
We conducted a multi-center, cross-sectional study ("COPD Outcomes-based Network for Clinical Effectiveness & Research Translation" [CONCERT]). We analyzed patients who met spirometric criteria for COPD, and completed EQ-5D-5L and PROMIS questionnaires. Disease severity was graded based on the Global Initiative for Chronic Obstructive Lung Disease (GOLD) classification. Pulmonary function test, PROMIS-43, EQ-5D (index score and EQ-Visual Analog Scale [EQ-VAS]), six minute walk test (6MWT), and three dyspnea scales (mMRC, Borg, FACIT-Dyspnea) were administered. Validity and reliability of EQ-5D-5L and PROMIS-43 were examined, and differences in HRQL by GOLD grade were assessed.
Data from 670 patients with COPD were analyzed (mean age 68.5 years; 58% male). More severe COPD was associated with more problems with mobility, self-care and usual activities (all p-values <0.01) according to EQ-5D-5L. Related domains on EQ-5D-5L, PROMIS and clinical measures were moderately (r = 0.30-0.49) to strongly (r ≥ 0.50) correlated. A statistically significant trend of decreasing HRQL with more severe lung functions was observed for EQ-5D-5L index scores, EQ-VAS scores, and PROMIS physical function and social roles.
Results supported the validity of EQ-5D-5L and PROMIS-43 in COPD patients, and indicate that physical function and social activities decrease with level of lung function by GOLD grade, but not pain, mental health, sleep or fatigue as reported by patients.
患者报告结局测量信息系统43项简表（PROMIS - 43）和五级EQ - 5D（EQ - 5D - 5L）是最近开发的与健康相关生活质量（HRQL）的测量工具，在评估治疗效果和反映呼吸道相关疾病负担方面可能具有广泛应用。本研究的目的是：（1）检验它们在慢性阻塞性肺疾病（COPD）患者中的心理测量特性，以及（2）确定HRQL中因肺功能不同而有差异和无差异的维度。
我们开展了一项多中心横断面研究（“基于COPD结局的临床有效性与研究转化网络”[CONCERT]）。我们分析了符合COPD肺量计标准且完成EQ - 5D - 5L和PROMIS问卷的患者。根据慢性阻塞性肺疾病全球倡议（GOLD）分类对疾病严重程度进行分级。进行了肺功能测试、PROMIS - 43、EQ - 5D（指数得分和EQ视觉模拟量表[EQ - VAS]）、六分钟步行试验（6MWT）以及三个呼吸困难量表（mMRC、Borg、FACIT - 呼吸困难）的评估。检验了EQ - 5D - 5L和PROMIS - 43的有效性和可靠性，并评估了不同GOLD分级患者的HRQL差异。
分析了670例COPD患者的数据（平均年龄68.5岁；58%为男性）。根据EQ - 5D - 5L，更严重的COPD与更多的活动能力、自我护理和日常活动问题相关（所有p值<0.01）。EQ - 5D - 5L、PROMIS和临床测量中的相关领域呈中度（r = 0.30 - 0.49）至高度（r≥0.50）相关。对于EQ - 5D - 5L指数得分、EQ - VAS得分以及PROMIS身体功能和社会角色，观察到随着肺功能越严重HRQL下降的统计学显著趋势。
结果支持EQ - 5D - 5L和PROMIS - 43在COPD患者中的有效性，并表明身体功能和社会活动随GOLD分级的肺功能水平下降，但患者报告的疼痛、心理健康、睡眠或疲劳情况并非如此。
