Hettle Robert, Borrill John, Suri Gaurav, Wulff Jerome
Parexel Consulting, London, UK.
AstraZeneca, Macclesfield, UK.
Clinicoecon Outcomes Res. 2015 Nov 26;7:615-27. doi: 10.2147/CEOR.S92078. eCollection 2015.
In the absence of EuroQol 5D data, mapping algorithms can be used to predict health-state utility values (HSUVs) for use in economic evaluation. In a placebo-controlled Phase II study of olaparib maintenance therapy (NCT00753545), health-related quality of life was measured using the Functional Assessment of Cancer Therapy - Ovarian (FACT-O) questionnaire. Our objective was to generate HSUVs from the FACT-O data using published mapping algorithms.
Algorithms were identified from a review of the literature. Goodness-of-fit and patient characteristics were compared to select the best-performing algorithm, and this was used to generate base-case HSUVs for the intention-to-treat population of the olaparib study and for patients with breast cancer antigen mutations.
Four FACT - General (the core component of FACT-O) mapping algorithms were identified and compared. Under the preferred algorithm, treatment-related adverse events had no statistically significant effect on HSU (P>0.05). Discontinuation of the study treatment and breast cancer antigen mutation status were both associated with a reduction in HSUVs (-0.06, P=0.0009; and -0.03, P=0.0511, respectively). The mean HSUV recorded at assessment visits was 0.786.
FACT - General mapping generated credible HSUVs for an economic evaluation of olaparib. As reported in other studies, different algorithms may produce significantly different estimates of HSUV. For this reason, it is important to test whether the choice of a specific algorithm changes the conclusions of an economic evaluation.
在缺乏欧洲五维健康量表(EuroQol 5D)数据的情况下,映射算法可用于预测健康状态效用值(HSUV),以用于经济评估。在一项关于奥拉帕利维持治疗的安慰剂对照II期研究(NCT00753545)中,使用癌症治疗功能评估 - 卵巢癌(FACT - O)问卷来测量健康相关生活质量。我们的目标是使用已发表的映射算法从FACT - O数据中生成HSUV。
通过文献综述确定算法。比较拟合优度和患者特征以选择表现最佳的算法,并使用该算法为奥拉帕利研究的意向性治疗人群以及患有乳腺癌抗原突变的患者生成基础病例HSUV。
确定并比较了四种FACT - 通用量表(FACT - O的核心组成部分)映射算法。在首选算法下,与治疗相关的不良事件对HSU没有统计学上的显著影响(P>0.05)。研究治疗的中断和乳腺癌抗原突变状态均与HSUV的降低相关(分别为-0.06,P = 0.0009;和-0.03,P = 0.0511)。评估访视时记录的平均HSUV为0.786。
FACT - 通用量表映射为奥拉帕利的经济评估生成了可靠的HSUV。正如其他研究中所报道的,不同的算法可能会产生显著不同的HSUV估计值。因此,测试特定算法的选择是否会改变经济评估的结论非常重要。