Bernhard J, Hürny C, Coates A S, Peterson H F, Castiglione-Gertsch M, Gelber R D, Galligioni E, Marini G, Thürlimann B, Forbes J F, Goldhirsch A, Senn H J, Rudenstam C M
Br J Cancer. 1998 Sep;78(5):686-93. doi: 10.1038/bjc.1998.561.
Quality of life (QL) is used to assess treatments in clinical trials but may be influenced by other factors. We analysed the impact of biomedical, sociodemographic and cultural factors on baseline QL indicators in two International Breast Cancer Study Group trials. Patients with stage II breast cancer were randomized within 6 weeks of primary surgery to various adjuvant treatments. They were asked to assess five indicators of QL at baseline. QL forms were available for 1231 (83%) of the 1475 premenopausal and 989 (82%) of the 1212 post-menopausal patients, who were from nine countries and spoke seven languages. Culture (defined as language/country groups) had a statistically significant impact on baseline QL measures. Premenopausal patients with poor prognostic factors showed a tendency to report worse QL, with oestrogen receptor status as an independent predictor for mood (P = 0.0005). Older post-menopausal patients reported better emotional wellbeing (P = 0.002), mood (P = 0.002), and less effort to cope (P = 0.0009) compared with younger post-menopausal patients. Co-morbidity, type of surgery, treatment assignment and sociodemographic factors showed a statistically significant impact in post-menopausal patients only. Cultural and biomedical factors influenced baseline QL and should be considered when evaluating the impact of treatment on QL in international breast cancer clinical trials.
生活质量（QL）用于评估临床试验中的治疗方法，但可能会受到其他因素的影响。我们在两项国际乳腺癌研究组试验中分析了生物医学、社会人口统计学和文化因素对基线QL指标的影响。II期乳腺癌患者在初次手术后6周内被随机分配接受各种辅助治疗。他们被要求在基线时评估QL的五个指标。1475名绝经前患者中有1231名（83%）、1212名绝经后患者中有989名（82%）填写了QL表格，这些患者来自九个国家，说七种语言。文化（定义为语言/国家组）对基线QL测量有统计学上的显著影响。具有不良预后因素的绝经前患者倾向于报告较差的QL，雌激素受体状态是情绪的独立预测因素（P = 0.0005）。与年轻的绝经后患者相比，年龄较大的绝经后患者报告的情绪幸福感更好（P = 0.002）、情绪更好（P = 0.002），且应对努力更少（P = 0.0009）。合并症、手术类型、治疗分配和社会人口统计学因素仅在绝经后患者中显示出统计学上的显著影响。文化和生物医学因素影响基线QL，在评估国际乳腺癌临床试验中治疗对QL的影响时应予以考虑。
