Cocks Kim, King Madeleine T, Velikova Galina, Fayers Peter M, Brown Julia M
Clinical Trials Research Unit, University of Leeds, UK.
Eur J Cancer. 2008 Sep;44(13):1793-8. doi: 10.1016/j.ejca.2008.05.008. Epub 2008 Jul 1.
To review reporting standard, presentation and interpretation for quality of life (QOL) outcomes in randomised controlled trials (RCTs) using the European Organisation for Research and Treatment of Cancer quality of life questionnaire core 30 (EORTC QLQ-C30).
Cancer RCTs reporting EORTC QLQ-C30 data were identified and reviewed against a reporting quality checklist. Interpretation/presentation methods for QOL data were also recorded.
Eighty-two papers were reviewed. Seventy percent met criteria for high quality reporting; 94% reported mean scores; 84% presented results in tables/graphs; 80% reported p-values or statistical significance. Clinical significance was addressed in 38%. Where clinical significance was not addressed, reliance was usually on statistical significance to interpret the results.
EORTC QLQ-C30 results are generally reported well, although it was common to rely on statistical significance alone for interpreting results. Whilst interpretation in terms of clinical significance has improved in recent years, there is still a lack of robust clinical interpretation of QOL results even in papers reported to a high standard.
使用欧洲癌症研究与治疗组织生活质量问卷核心30（EORTC QLQ-C30），回顾随机对照试验（RCT）中生活质量（QOL）结果的报告标准、呈现方式及解读。
识别并对照报告质量清单，对报告EORTC QLQ-C30数据的癌症RCT进行回顾。还记录了QOL数据的解读/呈现方法。
共回顾了82篇论文。70%符合高质量报告标准；94%报告了平均分；84%以表格/图表形式呈现结果；80%报告了p值或统计学显著性。38%讨论了临床意义。在未讨论临床意义的情况下，通常依靠统计学显著性来解读结果。
EORTC QLQ-C30结果总体报告良好，不过通常仅依靠统计学显著性来解读结果。尽管近年来在临床意义方面的解读有所改善，但即使在报告标准较高的论文中，对QOL结果仍缺乏有力的临床解读。
