Hürny C, Bernhard J, Coates A, Peterson H F, Castiglione-Gertsch M, Gelber R D, Rudenstam C M, Collins J, Lindtner J, Goldhirsch A, Senn H J
Medical Division Lory, Inselspital, Bern, Switzerland.
Med Care. 1996 Mar;34(3):234-48. doi: 10.1097/00005650-199603000-00004.
A single-item linear analogue self-assessment scale for mood was compared with a 28-item adjective checklist for emotional well-being. To confirm its concurrent validity and responsiveness to treatment and recurrence in patients with breast cancer, emotional well-being was assessed every 3 months for 2 years and at 1 and 6 months after recurrence in 1,169 patients who were premenopausal and 960 patients who were postmenopausal. These patients were enrolled in two International Breast Cancer Study Group randomized clinical trials in operable breast cancer conducted from 1986 to 1993. To assess concurrent validity, Pearson's correlation between the linear analogue self-assessment scale and the adjective checklist were calculated for each time-point within each treatment group and for the two assessments after recurrence. Responsiveness to treatment and recurrence were analyzed using paired t tests and the squared ratio of these t tests, an estimate of relative efficiency. Concurrent validity of the mood linear analogue self-assessment was consistently confirmed across four language groups. Both measures were responsive; out of 24 changes over time, 19 were in the expected direction for the linear analogue self-assessment scale (p < or = 0.05 for 9 of 19) and 17 for the adjective checklist (p < or = 0.05 for 10 of 17). The linear analogue self-assessment scale was less but significantly efficient for detection of treatment effects, with relative efficiency estimates ranging from 0.16 to 2.45 and a median of 0.66 among the comparisons with relatively stable estimates (/t/ > or = 1.0) and more efficient for recurrence than the adjective checklist. The mood linear analogue self-assessment scale is a valid indicator of emotional well-being in patients with breast cancer in large multicenter, multicultural trials in which comprehensive scales are less feasible. This investigation supports the clinical relevance of linear analogue self-assessment scales as indicators of components of quality of life in cancer clinical trials.
将一种用于情绪的单项线性模拟自评量表与一份包含28个条目的情绪健康形容词核对表进行了比较。为了证实其在乳腺癌患者中的同时效度以及对治疗和复发的反应性，对1169名绝经前患者和960名绝经后患者每3个月评估一次情绪健康状况，持续2年，并在复发后的1个月和6个月进行评估。这些患者参加了1986年至1993年开展的两项国际乳腺癌研究组关于可手术乳腺癌的随机临床试验。为了评估同时效度，计算了每个治疗组内每个时间点以及复发后两次评估时线性模拟自评量表与形容词核对表之间的Pearson相关性。使用配对t检验以及这些t检验的平方比（相对效率的一种估计）分析对治疗和复发的反应性。情绪线性模拟自评的同时效度在四个语言组中均得到一致证实。两种测量方法都有反应性；在24次随时间的变化中，线性模拟自评量表有19次变化方向符合预期（19次中有9次p≤0.05），形容词核对表有17次（17次中有10次p≤0.05）。线性模拟自评量表在检测治疗效果方面效率较低但具有显著意义，相对效率估计值在0.16至2.45之间，在与相对稳定估计值（/t/≥1.0）的比较中中位数为0.66，并且在检测复发方面比形容词核对表更有效。在大型多中心、多文化试验中，当综合量表不太可行时，情绪线性模拟自评量表是乳腺癌患者情绪健康的有效指标。这项研究支持了线性模拟自评量表作为癌症临床试验中生活质量组成部分指标的临床相关性。
