Department of Dermatology, Medical Faculty Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany.
J Invest Dermatol. 2011 Mar;131(3):623-30. doi: 10.1038/jid.2010.303. Epub 2010 Oct 14.
There is wide variation in the use of outcome measures for eczema. We performed a three-stage web-based international Delphi exercise to develop consensus-based sets of core outcome domains for eczema for "controlled trials" and "clinical recordkeeping". A total of 57 individuals from four stakeholder groups (consumers, clinical experts, regulatory agency representatives, and journal editors) representing 13 countries were asked to rate the importance of 19 outcome domains for eczema and to choose which domains should be included in two core sets of outcomes. Forty-six individuals (81%) participated. Participants received standardized feedback, including the group median, interquartile range, and previous responses, and the assessment was repeated in two subsequent rounds. We defined consensus a priori if at least 60% of the members of at least three stakeholder groups, including consumers, recommended domain inclusion in the core set. Consensus was achieved for inclusion of symptoms, physician-assessed clinical signs, and a measurement for long-term control of flares in the core set of outcome domains for eczema trials. We recommend including these three core outcomes in future eczema trials in order to enhance clinical interpretability and to enable meta-analyses across different studies. For recordkeeping, consensus was reached to regularly monitor eczema symptoms in clinical practice. Future work is needed to select which existing or new scales should be used to measure the domains identified as relevant for the core set.
在湿疹的疗效评估指标的应用方面存在广泛的差异。我们进行了一个三阶段的基于网络的国际 Delphi 研究，旨在为湿疹的“对照试验”和“临床记录”制定基于共识的核心疗效评估领域集。共有来自四个利益相关者群体（患者、临床专家、监管机构代表和期刊编辑）的 57 名个体（来自 13 个国家）被要求对 19 个湿疹疗效评估领域的重要性进行评分，并选择应纳入两个核心疗效评估领域集的领域。共有 46 名参与者（81%）参与了研究。参与者收到了标准化的反馈，包括组内中位数、四分位距和先前的回复，评估在随后的两轮中重复进行。我们预先定义了共识，如果至少 60%的来自至少三个利益相关者群体（包括患者）的成员建议将某个领域纳入核心领域集，那么就达成共识。纳入核心疗效评估领域集的共识包括症状、医生评估的临床体征以及长期控制病情发作的测量。我们建议在未来的湿疹试验中纳入这三个核心疗效评估领域，以增强临床可解释性并能够在不同研究之间进行荟萃分析。对于临床记录，达成了共识，即需要定期监测临床实践中的湿疹症状。未来需要开展工作来选择应使用哪些现有的或新的量表来测量确定为核心集相关的领域。
