Casali P, Licitra L, Costantini M, Santoro A, Viterbori P, Bajetta E, Bruzzi P
Division of Medical Oncology A, Istituto Nazionale per lo Studio e la Cura dei Tumori, Milan, Italy.
Ann Oncol. 1997 Dec;8(12):1207-11. doi: 10.1023/a:1008276901910.
Survival and quality of life are the two end-points of cancer treatment. Recommendations are available as to how quality of life should be assessed in clinical studies in order for quantitative scores to be provided for it, along with survival data. The two measurements can be combined, and their total should yield a definition of the state of the art in cancer treatment with respect to both the quantity and the quality of life. However, at the individual level, quality of life can be traded off against survival only by taking into account the patient's attitude toward risk. More importantly, the quality of health status may be valued in a completely different way from patient to patient. Thus, when a clinical choice is to be made from among different treatment options, the ethical principle of respect for the patient's autonomy would require that the patient be informed of their possible respective outcomes, and allowed to provide his/her own assessment of the quality of life associated with these outcomes. This might have consequences for quality of life assessment in clinical studies, which should not only quantify average scores for treatment comparisons, but also provide a 'health state description' with respect to the aftermath of each of the treatment options. These data could be formalized in the already proposed decision instruments incorporating clinical scenarios for patient information. In any case, this should allow individualized clinical decisions incorporating each patient's preferences for the quality of his/her expected life span. Providing average quality of life scores may be useful, indeed, for population-based health decisions, as are those on resource allocation and those on registration of new drugs.
生存和生活质量是癌症治疗的两个终点。关于在临床研究中应如何评估生活质量，以便能为其提供定量评分并与生存数据一起给出相关建议。这两项测量可以结合起来，它们的总和应能给出癌症治疗在生活质量和数量方面的最新状况定义。然而，在个体层面，只有考虑到患者对风险的态度，生活质量才能与生存进行权衡。更重要的是，不同患者对健康状况质量的重视方式可能完全不同。因此，当要从不同治疗方案中做出临床选择时，尊重患者自主权的伦理原则要求告知患者各个方案可能的结果，并允许患者对与这些结果相关的生活质量给出自己的评估。这可能会对临床研究中的生活质量评估产生影响，临床研究不仅应量化用于治疗比较的平均评分，还应针对每个治疗方案的后果提供“健康状态描述”。这些数据可以在已提出的包含患者信息临床场景的决策工具中进行形式化。无论如何，这应能允许做出个性化的临床决策，纳入每个患者对其预期寿命质量的偏好。提供平均生活质量评分确实可能对基于人群的健康决策有用，比如资源分配决策和新药注册决策。
