Efficace F, Bottomley A, Vanvoorden V, Blazeby J M
European Organisation for Research and Treatment of Cancer, EORTC Data Center, Quality of Life Unit, Avenue E. Mounier, 83, 1200 Brussels, Belgium.
Eur J Cancer. 2004 Jan;40(2):187-97. doi: 10.1016/j.ejca.2003.10.012.
Although health-related quality of life (HRQOL) is increasingly reported as an important endpoint in cancer clinical trials, questions still remain about the quality of its reporting. The aim of this study was to evaluate the level of reporting of HRQOL in randomised controlled trials (RCTs) of colorectal cancer (CRC). A systematic literature search from 1980 to March 2003 was undertaken on a number of databases. Identified eligible studies were selected and then evaluated on a broad set of HRQOL predetermined criteria by four reviewers. Thirty-one randomised controlled trials involving 9683 colorectal cancer patients were identified. Nearly all studies dealt with metastatic patients and principally compared different chemotherapy regimens. The HRQOL tool most often used was the European Organisation for Research and Treatment of Cancer, Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30), which was used in 48% of the studies. Some methodological limitations were identified: 39% of the RCTs did not report HRQOL compliance at baseline and 52% did not give details on missing data. A rationale for using a specific HRQOL measure was given in only 10% of the studies. Whilst HRQOL assessment is a potential valuable source of information in understanding the impact of colorectal cancer, a number of methodological shortcomings have to be further addressed in future studies.
尽管与健康相关的生活质量（HRQOL）越来越多地被报告为癌症临床试验中的一个重要终点，但关于其报告质量的问题仍然存在。本研究的目的是评估结直肠癌（CRC）随机对照试验（RCT）中HRQOL的报告水平。对多个数据库进行了1980年至2003年3月的系统文献检索。选择已确定的符合条件的研究，然后由四位评审员根据一系列预先确定的HRQOL标准进行评估。确定了31项涉及9683名结直肠癌患者的随机对照试验。几乎所有研究都涉及转移性患者，主要比较了不同的化疗方案。最常使用的HRQOL工具是欧洲癌症研究与治疗组织生活质量问卷核心30（EORTC QLQ-C30），48%的研究使用了该工具。发现了一些方法学上的局限性：39%的RCT未报告基线时的HRQOL依从性，52%未详细说明缺失数据。只有10%的研究给出了使用特定HRQOL测量方法的理由。虽然HRQOL评估是了解结直肠癌影响的潜在有价值的信息来源，但未来的研究必须进一步解决一些方法学上的缺陷。
