Patient-Centered Research, Evidera, 7101 Wisconsin Avenue, Suite 1400, 20814, Bethesda, MD, USA.
Helsinn Therapeutics (US), Inc, 170 Wood Avenue South, 5th Floor, Iselin, NJ, 08830, USA.
Qual Life Res. 2019 Jun;28(6):1641-1653. doi: 10.1007/s11136-019-02135-7. Epub 2019 Feb 22.
Comprehensive (qualitative and quantitative) assessments of the 12-item functional assessment of anorexia/cachexia therapy (FAACT) anorexia/cachexia subscale (A/CS) and relevant subscales were undertaken for use in constructing potential endpoints in clinical trials of non-small cell lung cancer (NSCLC) with involuntary weight loss.
Eleven participants (≥ 18 years) from six clinical sites with a diagnosis of stage III unresectable or stage IV NSCLC and involuntary weight loss (either ≥ 5% body weight loss within six months prior to screening or screening BMI < 20 kg/m) were interviewed to evaluate the content validity of the A/CS domain. A psychometric evaluation was conducted on the A/CS domain, and symptoms and concerns subscales, using data from previously completed phase III clinical trials (ROMANA1 [N = 474] and ROMANA2 [N = 488]).
Anorexia-related symptoms were highly relevant to participants and had important impacts on their lives including energy levels, and physical, social, and psychological functioning. The majority of participants endorsed the A/CS domain items and found them to be easily understood, relevant, and comprehensive. Confirmatory factor analyses established that the A/CS symptoms and concerns subscales provided an acceptable fit as single factor models in ROMANA1 and ROMANA2. Reliability, validity, and responsiveness were established for the 12item A/CS domain, 5item anorexia symptoms subscale, and 4-item anorexia concerns subscale.
These scales have good content validity, favorable psychometric properties, and can be used for characterizing the effect of treatment on anorexia symptoms and/or anorexia-related concerns in patients with NSCLC.
对 12 项厌食/恶病质治疗功能性评估量表（FAACT）的厌食/恶病质子量表（A/CS）和相关子量表进行全面（定性和定量）评估，以便在非小细胞肺癌（NSCLC）伴非自愿性体重减轻的临床试验中构建潜在终点。
来自六个临床地点的 11 名参与者（≥18 岁）患有不可切除的 III 期或 IV 期 NSCLC 和非自愿性体重减轻（筛选前六个月内体重至少下降 5%或筛选时 BMI<20kg/m），对 A/CS 领域的内容有效性进行了访谈。使用先前完成的 III 期临床试验（ROMANA1[N=474]和 ROMANA2[N=488]）的数据对 A/CS 领域和症状及关注点子量表进行了心理测量评估。
与参与者高度相关的与厌食相关的症状对他们的生活有重要影响，包括能量水平、身体、社会和心理功能。大多数参与者认可 A/CS 领域的项目，并发现它们易于理解、相关且全面。验证性因子分析表明，A/CS 症状和关注点子量表在 ROMANA1 和 ROMANA2 中作为单因子模型提供了可接受的拟合度。12 项 A/CS 领域、5 项厌食症状子量表和 4 项厌食关注点子量表的可靠性、有效性和反应性均得到确立。
这些量表具有良好的内容有效性、良好的心理计量学特性，可用于描述治疗对 NSCLC 患者厌食症状和/或与厌食相关的关注点的影响。
