Lloyd Andrew J, Kerr Cicely, Penton James, Knerer Gerhart
ICON Patient Reported Outcomes, Oxford, UK.
ICON Patient Reported Outcomes, Oxford, UK; Janssen-Cilag Ltd, High Wycombe, UK.
Value Health. 2015 Dec;18(8):1152-7. doi: 10.1016/j.jval.2015.08.012. Epub 2015 Oct 21.
The collection of preference-based health outcomes data (or utility values) is required to support cost-effectiveness analyses.
This study aimed to collect health-related quality of life (HRQOL) data in men with metastatic castration-resistant prostate cancer (CRPC) stratified by disease states.
Men with metastatic CRPC were recruited via UK patient associations, patient panels, and specialist recruiters and classified into four subgroups reflecting disease state: asymptomatic/mildly symptomatic before chemotherapy, symptomatic before chemotherapy, receiving chemotherapy, and postchemotherapy. HRQOL data (including five-level EuroQol five-dimensional questionnaire [EQ-5D-5L], European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire [EORTC QLQ-C30], and 25-item prostate cancer-specific questionnaire module designed to supplement the EORTC QLQ-C30) along with background and medical history data were collected via an online survey. The EQ-5D-5L and the EORTC-8D (EORTC-8D is an 8 dimensional utility index scored from QLQ-C30 data) were both used to estimate utilities.
Data were collected from a total sample of 163 men with metastatic CRPC. Utility values elicited by the EQ-5D-5L ranged from 0.830 for the asymptomatic/mildly symptomatic before chemotherapy disease state (95% confidence interval [CI] 0.795-0.865) to 0.625 for the symptomatic before chemotherapy disease state (95% CI 0.577-0.673). EORTC-8D utilities ranged from 0.856 (95% CI 0.831-0.882) to 0.697 (95% CI 0.664-0.731) for the same disease/treatment states.
This online survey was designed to capture real-world HRQOL data describing men with CRPC. The study estimated utilities using two alternative methods, and the results show good agreement, suggesting that they are robust. This methodology offers a potentially higher quality alternative to vignette-based methods that are commonly used in oncology submissions.
为支持成本效益分析，需要收集基于偏好的健康结局数据（或效用值）。
本研究旨在收集转移性去势抵抗性前列腺癌（CRPC）男性患者按疾病状态分层的健康相关生活质量（HRQOL）数据。
通过英国患者协会、患者小组和专业招募人员招募转移性CRPC男性患者，并将其分为反映疾病状态的四个亚组：化疗前无症状/轻度症状、化疗前有症状、接受化疗和化疗后。通过在线调查收集HRQOL数据（包括五级欧洲五维健康量表[EQ-5D-5L]、欧洲癌症研究与治疗组织核心生活质量问卷[EORTC QLQ-C30]以及为补充EORTC QLQ-C30而设计的25项前列腺癌特异性问卷模块）以及背景和病史数据。EQ-5D-5L和EORTC-8D（EORTC-8D是一个从QLQ-C30数据中评分的8维效用指数）均用于估计效用。
共收集了163例转移性CRPC男性患者的样本数据。EQ-5D-5L得出的效用值范围从化疗前无症状/轻度症状疾病状态的0.830（95%置信区间[CI]0.795-0.865）到化疗前有症状疾病状态的0.625（95%CI 0.577-0.673）。对于相同的疾病/治疗状态，EORTC-8D效用值范围从0.856（95%CI 0.831-0.882）到0.697（95%CI 0.664-0.731）。
本次在线调查旨在获取描述CRPC男性患者的真实世界HRQOL数据。该研究使用两种替代方法估计效用，结果显示出良好的一致性，表明它们具有可靠性。这种方法为肿瘤学申报中常用的基于 vignette 的方法提供了一种潜在的更高质量的替代方案。
