Reporting health-related quality of life in randomised clinical trials evaluating adjuvant systemic therapy: recommendations of Common-Sense Oncology and the European Organisation for Research and Treatment of Cancer.

Adjuvant treatment adds side-effects and can impair health-related quality of life (HRQOL); this must be balanced against a reduction in the probability of recurrence, which has a substantial negative effect on HRQOL.

辅助治疗会增加副作用，并可能损害与健康相关的生活质量（HRQOL）；必须权衡这与复发概率降低之间的关系，后者对HRQOL有显著的负面影响。

Since many adjuvant therapies lead to small gains in relapse-free or overall survival, the severity and duration of treatment-related side-effects and their impact on patient functioning and overall HRQOL are relevant to clinical decision making.

由于许多辅助治疗只能带来微小的无复发生存或总生存率的提高，治疗相关副作用的严重程度和持续时间以及它们对患者功能和整体HRQOL的影响，对于临床决策至关重要。

To facilitate understanding by oncologists and patients, we recommend reporting in publications the proportion of patients receiving adjuvant therapy who experience a prespecified deterioration in a relevant and validated HRQOL scale, and the duration of this deterioration during and after treatment completion, with appropriate handling of missing data and intercurrent events.

为了帮助肿瘤科医生和患者理解，我们建议在出版物中报告接受辅助治疗的患者中，有一定比例的人在预设的相关且经过验证的HRQOL量表中经历了恶化，并报告这种恶化在治疗完成期间及之后的持续时间，同时适当处理缺失数据和并发事件。

HRQOL assessment should include symptoms, functioning domains, and overall HRQOL.

HRQOL评估应包括症状、功能领域和整体HRQOL。

Between-group comparisons should address key HRQOL outcomes (as defined by both oncologists and patients) supplemented by descriptive outcomes across remaining HRQOL domains.

在进行组间比较时，应关注关键的HRQOL结果（由肿瘤科医生和患者共同定义），并补充描述其余HRQOL领域的结果。

Once the proportion of patients with specific adverse changes in symptoms is identified, it is possible to determine if specific patient group(s) are at particular risk for these effects.

一旦确定了具有特定不良症状变化的患者比例，就可以确定是否特定的患者群体对这些效果有特别的风险。

HRQOL information should be included in the primary report of trials evaluating adjuvant therapy as it is key to informed decisions about treatment choice, and updated long-term evaluation is also important to capture any lasting deficits in HRQOL.

应将HRQOL信息纳入评估辅助治疗的试验的主要报告中，因为它是关于治疗选择的明智决策的关键，并且更新的长期评估也很重要，以捕捉任何持久的HRQOL缺陷。