Bottomley Andrew, Aaronson Neil K
European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Unit and Quality of Life Group, Brussels, Belgium.
J Clin Oncol. 2007 Nov 10;25(32):5082-6. doi: 10.1200/JCO.2007.11.3183.
Over recent decades, health-related quality of life (HRQOL) research has been increasingly integrated into cancer clinical trials. The purpose of this review is to examine the overall approach taken towards clinical trial-based HRQOL investigations within the European Organisation for Research and Treatment of Cancer (EORTC). This article reports a literature review of clinical trial-based HRQOL investigations and provides selective examples of HRQOL studies in phase III clinical trials in various disease sites. The findings of this review highlight that, historically, assessing HRQOL was a challenge. However, as EORTC has become more experienced in the assessment of HRQOL and has developed a portfolio of appropriate tools, HRQOL has become a more accepted end point in large-scale trials. The trials reviewed in this article show that, in general, HRQOL data do provide information that can both inform clinicians about the effectiveness of the treatments and also serve as an invaluable source of information for patients to make informed decisions regarding the treatment choice.
在最近几十年里，健康相关生活质量（HRQOL）研究越来越多地融入癌症临床试验。本综述的目的是审视欧洲癌症研究与治疗组织（EORTC）在基于临床试验的HRQOL调查中所采用的总体方法。本文报告了对基于临床试验的HRQOL调查的文献综述，并提供了不同疾病部位III期临床试验中HRQOL研究的精选实例。该综述的结果突出表明，从历史上看，评估HRQOL是一项挑战。然而，随着EORTC在HRQOL评估方面经验日益丰富并开发了一系列合适的工具，HRQOL已成为大规模试验中更被接受的终点。本文所综述的试验表明，总体而言，HRQOL数据确实能提供信息，既能让临床医生了解治疗的有效性，也能作为患者在治疗选择方面做出明智决策的宝贵信息来源。
