Division of Medical Oncology, Department of Medicine, Duke University Medical Center, Durham, NC 27710, USA.
Lancet Oncol. 2012 Feb;13(2):e77-82. doi: 10.1016/S1470-2045(11)70215-7.
Best supportive care is poorly defined in clinical trials, and a standard framework for delivery of such care is needed, using best available evidence and allowing replication of studies. We convened a panel of 36 experts to develop consensus statements via the Delphi method. The first round included open-ended questions; subsequent rounds sought to develop consensus-based standards. Consensus was assessed by use of a 5-point Likert agreement scale; more than 70% of panellists had to give a score of 5 to meet a-priori levels of consensus. The panel identified four key domains of best supportive care in clinical trials: multidisciplinary care; supportive care documentation; symptom assessment; and symptom management. Consensus was reached on 11 statements within these four domains. For example, 24 (96%) panellists recommended that the intervals between symptom assessments should be identical for control and experimental groups. Availability of resources was cited as a challenge to implementation of best supportive care standards.
最佳支持性护理在临床试验中定义不明确，需要使用最佳现有证据并允许研究复制来制定提供此类护理的标准框架。我们召集了一个由 36 名专家组成的小组，通过德尔菲法达成共识声明。第一轮包括开放性问题；随后的几轮旨在制定基于共识的标准。使用 5 分李克特同意量表评估共识；小组中超过 70%的成员必须得分为 5 分，才能达到事先设定的共识水平。该小组确定了临床试验中最佳支持性护理的四个关键领域：多学科护理；支持性护理文件记录；症状评估；以及症状管理。在这四个领域达成了 11 项共识声明。例如，24 名（96%）小组成员建议，对照组和实验组之间的症状评估间隔应相同。资源的可获得性被认为是实施最佳支持性护理标准的挑战。
