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晚期乳腺癌患者的主观健康评估(SHE):一种适用于临床试验的效用概念。

Subjective health estimations (SHE) in patients with advanced breast cancer: an adapted utility concept for clinical trials.

作者信息

Hürny C, van Wegberg B, Bacchi M, Bernhard J, Thürlimann B, Real O, Perey L, Bonnefoi H, Coates A

机构信息

Medical Division Lory, University Hospital Insel, Bern, Switzerland.

出版信息

Br J Cancer. 1998 Mar;77(6):985-91. doi: 10.1038/bjc.1998.162.

DOI:10.1038/bjc.1998.162
PMID:9528845
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC2150102/
Abstract

We wished to develop and validate a simple linear analogue self-assessment (LASA) scale to assess utility values in multicentre, multicultural breast cancer trials. We compared two variants of a LASA scale (score range 0-100) with different anchoring points [perfect health to worst possible health (subjective health estimation, SHE) and perfect health to death (SHED)] in 84 patients with advanced breast cancer. Feasibility was explored in the first 48 patients interviewed. Values from the LASA scales were compared with each other and with a time trade off (TTO) interview. Scores from the two LASA scales were highly correlated (r=0.8, P < 0.0001, Spearman). The relationship between TTO interview and SHE was confirmed with tests for trend across ordered groups (linear-trend test P < 0.001). Most patients preferred SHE to SHED. SHE scores (in which high scores indicate high-health-state values) were significantly different by type of treatment, time from diagnosis and age. Thus, significantly different mean SHE scores were obtained from patients receiving no treatment or hormone therapy, mild and intensive chemotherapy (ANOVA P=0.03) and from patients with diagnosis 2 years, 2-5 years, 5-10 years and more than 10 years before interview (ANOVA P=0.02). Older patients (> 56 years) had a lower mean on the SHE scale (53 vs 61; ANOVA P=0.04). We found that the two versions of the LASA scale were equivalent for clinical purposes. SHE appeared to provide a feasible, patient-preferred and valid alternative to lengthy TTO interviews in assessing the value patients attach to their present state of health in large-scale cancer clinical trials.

摘要

我们希望开发并验证一种简单的线性模拟自评(LASA)量表,用于评估多中心、多文化背景下乳腺癌试验中的效用值。我们在84例晚期乳腺癌患者中比较了LASA量表(评分范围0 - 100)的两种不同锚定点版本[从完美健康到可能最差的健康状态(主观健康评估,SHE)以及从完美健康到死亡(SHED)]。在最初访谈的48例患者中探索了其可行性。将LASA量表的值相互比较,并与时间权衡(TTO)访谈结果进行比较。两种LASA量表的得分高度相关(r = 0.8,P < 0.0001,Spearman)。通过对有序组的趋势检验(线性趋势检验P < 0.001)证实了TTO访谈与SHE之间的关系。大多数患者更喜欢SHE而非SHED。SHE评分(高分表示高健康状态值)因治疗类型、诊断时间和年龄而有显著差异。因此,接受无治疗或激素治疗、轻度和强化化疗的患者(方差分析P = 0.03)以及访谈前诊断时间为2年、2 - 5年、5 - 10年和超过10年的患者(方差分析P = 0.02)的平均SHE评分存在显著差异。年龄较大(> 56岁)的患者在SHE量表上的平均分较低(53对61;方差分析P = 0.04)。我们发现,两种版本的LASA量表在临床应用中是等效的。在大规模癌症临床试验中评估患者对其当前健康状态的重视程度时,SHE似乎为冗长的TTO访谈提供了一种可行、患者更偏好且有效的替代方法。

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