乳腺癌日趋成为全世界女性癌症死亡的首要原因，该疾病的随机对照研究用于衡量这些患者的健康相关生活质量（HRQOL）。
2016年7月，英国《柳叶刀肿瘤学分册》第17卷第7期正式发表欧洲癌症研究与治疗组织（EORTC）、欧洲疾病预防控制中心（ECDC）、英国布里斯托大学乳房重建生活质量研究协作组、比利时布鲁塞尔自由大学、国际乳腺癌研究协作组（BIG）、奥地利格拉茨医科大学、葡萄牙尚帕利莫临床中心、荷兰学术医学中心（阿姆斯特丹大学医学院和附属医院）、英国利兹大学的系统回顾，评估了49项符合条件的进展期乳腺癌随机对照研究用于报告HRQOL的方法是否适当。
该系统回顾将EORTC的研究结果与文献的研究结果进行比较，调查该领域HRQOL报告标准是否已经改变。
该系统回顾认为，虽然HRQOL报告总体有所改善，但是一些关键方面仍然存在问题，例如缺乏HRQOL研究假设以及过分强调统计学而非临床意义。
此外，随着新治疗方法和个体化医药的出现，带来新的挑战，并且需要改进HRQOL工具以覆盖新疗法的副作用。
Lancet Oncol. 2016 Jul;17(7):e294-304.
Health-related quality of life in locally advanced and metastatic breast cancer: methodological and clinical issues in randomised controlled trials.
Ghislain I, Zikos E, Coens C, Quinten C, Balta V, Tryfonidis K, Piccart M, Zardavas D, Nagele E, Bjelic-Radisic V, Cardoso F, Sprangers MA, Velikova G, Bottomley A; European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Group; Breast Cancer Group; EORTC Headquarters.
European Organisation for Research and Treatment of Cancer Headquarters, Brussels, Belgium; European Centre for Disease Prevention and Control, Stockholm, Sweden; Breast Reconstruction Quality of Life Group, University of Bristol, Bristol, UK; Institut Jules Bordet, Université Libre de Bruxelles, Brussels, Belgium; Breast International Group, Brussels, Belgium; Medical University of Graz, Graz, Austria; Champalimaud Clinical Center, Lisbon, Portugal; Academic Medical Center, Amsterdam, Netherlands; University of Leeds, Leeds, UK.
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.
PMID: 27396647
DOI: 10.1016/S1470-2045(16)30099-7
联系客服
