RELIABILITY AND VALIDITY OF THE FUNCTIONAL ASSESSMENT OF CANCER-THERAPY - LUNG (FACT-L) QUALITY-OF-LIFE INSTRUMENT
RELIABILITY AND VALIDITY OF THE FUNCTIONAL ASSESSMENT OF CANCER-THERAPY - LUNG (FACT-L) QUALITY-OF-LIFE INSTRUMENT
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DOI：
10.1016/0169-5002(95)00450-f
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发表时间：
1995-06-01
期刊：
影响因子：
5.3
通讯作者：
BONOMI, P
中科院分区：
文献类型：
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作者：
CELLA, DF;BONOMI, AE;BONOMI, P
FACT-L（第3版）是一种44项自我报告工具，用于测量多维生活质量。它有八种语言版本，目前正用于多项II期和III期肺癌临床试验。FACT-G（FACT-General）第2版的33项的可靠性和有效性先前已发表。本文报告了使用原始出版物中肺癌患者子样本对FACT-G的进一步验证数据，更重要的是，提供了肺癌子量表（LCS）的数据。9个LCS问题与FACT-G一起沿着给予116例肺癌患者。内部一致性（系数α）从0.53提高到0.68，通过删除两个与其他问题不相关的问题。在2个月时再次对41例患者的子集进行检测，以评价对体能状态评分（PSR）变化的敏感性，并获得FACT-G和7项LCS的有临床意义的变化评分估计值。使用趋势线性检验，获得总分（P = 0.03）、身体健康（PWB）子量表（P = 0.02）、功能健康（FWB）子量表（P = 0.05）和LCS（P = 0.03）对体能状态评分（PSR）变化的敏感性。21项试验结果指数（TOI），结合PWB、FWB和LCS评分，具有高度可靠性（系数a = 0.89），对PSR变化敏感，F（1，38）= 4.84（P = 0.01）。对于在参加肿瘤学临床试验期间完成FACT-L的肺癌患者，该TOI可能是患者报告的生活质量的最相关和最精确的指标。FACT-L也可能有助于评估癌症以外的肺部疾病患者的生活质量。
The FACT-L (version 3) is a 44-item self-report instrument which measures multidimensional quality of life. Available in eight languages, it is currently being used in several Phase II and III lung cancer clinical trials. Reliability and validity of the 33-item version 2 of the FACT-General (FACT-G) have previously been published. This paper reports further validation data on the FACT-G with a subsample of lung cancer patients from the original publication and, more importantly, presents data on the Lung Cancer Subscale (LCS). The nine LCS questions were administered along with the FACT-G to 116 patients with lung cancer. Internal consistency (coefficient alpha) was improved from 0.53 to 0.68 by dropping two questions which were uncorrelated with the others. A subset of 41 patients was tested again at 2 months to evaluate sensitivity to change in performance status rating (PSR) and to obtain estimates of a clinically meaningful change score for the FACT-G and the 7-item LCS. Using a linear test for trend, sensitivity to change in performance status rating (PSR) was obtained with the Total score (P = 0.03), the Physical Well Being (PWB) subscale (P = 0.02), the Functional Well Being (FWB) subscale (P = 0.05), and the LCS (P = 0.03). A 21-item Trial Outcome Index (TOI), combining scores on PWB, FWB and LCS, was highly reliable (coefficient a = 0.89) and sensitive to change in PSR F(1,38) = 4.84 (P = 0.01). This TOI is probably the most relevant and precise indicator of patient-reported quality of life available for lung cancer patients who complete the FACT-L while participating in an oncology clinical trial. The FACT-L may also be of benefit in evaluating quality of life in patients with lung diseases other than cancer.