European Organisation for Research and Treatment of Cancer Headquarters, Brussels, Belgium.
European Centre for Disease Prevention and Control, Stockholm, Sweden.
Lancet Oncol. 2016 Jul;17(7):e294-e304. doi: 10.1016/S1470-2045(16)30099-7.
Breast cancer is the leading cause of cancer death among women worldwide, and increasingly, randomised controlled trials of this disease are measuring the health-related quality of life of these patients. In this systematic Review, we assess the adequacy of methods used to report health-related quality of life (HRQOL) from 49 eligible randomised controlled trials of advanced breast cancer. We compare our findings with those from the literature to investigate whether the standard of HRQOL reporting in this field has changed. We conclude that the overall reporting of HRQOL has improved, but some crucial aspects remain problematic, such as the absence of HRQOL research hypotheses and the overemphasis on statistical rather than clinical significance. Additionally, new challenges are arising with the emergence of novel treatments and the advent of personalised medicine, and improved HRQOL tools are required to cover the range of side-effects of newer therapies.
乳腺癌是全球女性癌症死亡的主要原因，越来越多的针对这种疾病的随机对照试验正在衡量这些患者的健康相关生活质量。在本系统评价中，我们评估了 49 项晚期乳腺癌随机对照试验中报告健康相关生活质量（HRQOL）的方法是否充分。我们将我们的发现与文献中的结果进行比较，以调查该领域的 HRQOL 报告标准是否有所改变。我们的结论是，HRQOL 的总体报告有所改善，但仍存在一些关键问题，例如缺乏 HRQOL 研究假设以及过分强调统计意义而非临床意义。此外，随着新型治疗方法的出现和个性化医学的出现，新的挑战也随之出现，需要改进 HRQOL 工具来涵盖新型治疗方法的一系列副作用。
