Breast Surgery, National Cancer Center-Hospital East, Kashiwa, Japan
Research Administration Center, Showa University, Shinagawa-ku, Tokyo, Japan.
BMJ Open. 2021 Dec 1;11(12):e046273. doi: 10.1136/bmjopen-2020-046273.
Although there is a lack of data on health-state utility values (HSUVs) for calculating quality-adjusted life-years in Japan, cost-utility analysis has been introduced by the Japanese government to inform decision making in the medical field since 2016.
This study aimed to determine whether the Lloyd model which was a predictive model of HSUVs for metastatic breast cancer (MBC) patients in the UK can accurately predict actual HSUVs for Japanese patients with MBC.
The prospective observational study followed by the validation study of the clinical predictive model.
Forty-four Japanese patients with MBC were studied at 336 survey points.
This study consisted of two phases. In the first phase, we constructed a database of clinical data prospectively and HSUVs for Japanese patients with MBC to evaluate the predictive accuracy of HSUVs calculated using the Lloyd model. In the second phase, Bland-Altman analysis was used to determine how accurately predicted HSUVs (based on the Lloyd model) correlated with actual HSUVs obtained using the EuroQol 5-Dimension 5-Level questionnaire, a preference-based measure of HSUVs in patients with MBC.
In the Bland-Altman analysis, the mean difference between HSUVs estimated by the Lloyd model and actual HSUVs, or systematic error, was -0.106. The precision was 0.165. The 95% limits of agreement ranged from -0.436 to 0.225. The t value was 4.6972, which was greater than the t value with 2 degrees of freedom at the 5% significance level (p=0.425).
There were acceptable degrees of fixed and proportional errors associated with the prediction of HSUVs based on the Lloyd model for Japanese patients with MBC. We recommend that sensitivity analysis be performed when conducting cost-effectiveness analyses with HSUVs calculated using the Lloyd model.
尽管日本缺乏用于计算质量调整生命年的健康状态效用值（HSUVs）的数据，但自 2016 年以来，日本政府已经引入了成本效用分析，以为医疗领域的决策提供信息。
本研究旨在确定英国转移性乳腺癌（MBC）患者的 HSUVs 预测模型 Lloyd 模型是否能准确预测日本 MBC 患者的实际 HSUVs。
前瞻性观察研究和临床预测模型的验证研究。
44 名日本 MBC 患者在 336 个调查点进行了研究。
本研究分为两个阶段。在第一阶段，我们前瞻性地构建了一个包含临床数据和日本 MBC 患者 HSUVs 的数据库，以评估 Lloyd 模型计算的 HSUVs 的预测准确性。在第二阶段，使用 Bland-Altman 分析来确定基于 Lloyd 模型预测的 HSUVs 与使用 EuroQol 5-Dimension 5-Level 问卷（一种用于评估 MBC 患者 HSUVs 的偏好测量方法）获得的实际 HSUVs 之间的相关性。
在 Bland-Altman 分析中，Lloyd 模型估计的 HSUVs 与实际 HSUVs 之间的平均差异，或系统误差，为-0.106。精度为 0.165。95%的一致性区间为-0.436 至 0.225。t 值为 4.6972，大于在 5%显著水平下自由度为 2 的 t 值（p=0.425）。
对于日本 MBC 患者，基于 Lloyd 模型预测 HSUVs 存在可接受的固定和比例误差。我们建议在使用 Lloyd 模型计算 HSUVs 进行成本效益分析时进行敏感性分析。
