Core Outcome Domains for Controlled Trials and Clinical Recordkeeping in Eczema: International Multiperspective Delphi Consensus Process
Core Outcome Domains for Controlled Trials and Clinical Recordkeeping in Eczema: International Multiperspective Delphi Consensus Process
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DOI：
10.1038/jid.2010.303
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发表时间：
2011-03-01
影响因子：
6.5
通讯作者：
Williams, Hywel C.
中科院分区：
文献类型：
--
作者：
Schmitt, Jochen;Langan, Sinead;Williams, Hywel C.
湿疹的结局指标的使用有很大的差异。我们进行了一个三阶段的基于网络的国际德尔菲练习，以开发基于共识的湿疹核心结果域集，用于“对照试验”和“临床记录保存”。来自13个国家的4个利益相关者群体（消费者、临床专家、监管机构代表和期刊编辑）共57名个人被要求对湿疹的19个结局领域的重要性进行评级，并选择哪些领域应纳入两组核心结局。46人（81%）参加。参与者收到标准化的反馈，包括组中位数，四分位数范围和以前的反应，并在随后的两轮中重复评估。如果至少有三个利益相关者群体（包括消费者）中至少有60%的成员建议将域包含在核心集中，则我们定义了先验共识。在湿疹试验的核心结果领域中，对纳入症状、医生评估的临床体征和长期控制发作的测量达成了共识。我们建议在未来的湿疹试验中纳入这三个核心结果，以提高临床可解释性，并使不同研究之间的荟萃分析成为可能。对于记录保存，达成共识，在临床实践中定期监测湿疹症状。今后需要开展工作，以选择应使用哪些现有或新的量表来衡量已确定与核心数据集相关的领域。
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.