Cella D F, Bonomi A E, Lloyd S R, Tulsky D S, Kaplan E, Bonomi P
Rush Cancer Institute, Chicago, IL, USA.
Lung Cancer. 1995 Jun;12(3):199-220. doi: 10.1016/0169-5002(95)00450-f.
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.
FACT-L（第3版）是一种包含44个条目的自评工具，用于测量多维生活质量。它有八种语言版本，目前正在多项肺癌II期和III期临床试验中使用。FACT-通用量表（FACT-G）第2版的33个条目版本的信效度先前已发表。本文报告了基于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，呈现了肺癌子量表（LCS）的数据。对116例肺癌患者同时施测了九个LCS问题和FACT-G。通过剔除两个与其他问题无关的问题，内部一致性（α系数）从0.53提高到了0.68。对41例患者在2个月时再次进行测试，以评估对性能状态评分（PSR）变化的敏感性，并获得FACT-G和7个条目的LCS具有临床意义的变化分数估计值。使用线性趋势检验，总分（P = 0.03）、生理健康（PWB）子量表（P = 0.02）、功能健康（FWB）子量表（P = 0.05）以及LCS（P = 0.03）对性能状态评分（PSR）变化具有敏感性。一个由21个条目组成的试验结果指数（TOI），结合了PWB、FWB和LCS的得分，具有高度可靠性（α系数 = 0.89）且对PSR的变化敏感，F(1,38) = 4.84（P = 0.01）。对于在参与肿瘤临床试验时完成FACT-L的肺癌患者，这个TOI可能是患者报告的生活质量最相关且精确的指标。FACT-L在评估非癌症肺部疾病患者的生活质量方面可能也有益处。
