迈向特应性皮炎研究结局指标的全球共识:HOME II 会议的结果。
Towards global consensus on outcome measures for atopic eczema research: results of the HOME II meeting.
机构信息
Centre for Evidence-Based Healthcare, University Hospital Dresden, Germany.
出版信息
Allergy. 2012 Sep;67(9):1111-7. doi: 10.1111/j.1398-9995.2012.02874.x. Epub 2012 Jul 30.
The use of nonstandardized and inadequately validated outcome measures in atopic eczema trials is a major obstacle to practising evidence-based dermatology. The Harmonising Outcome Measures for Eczema (HOME) initiative is an international multiprofessional group dedicated to atopic eczema outcomes research. In June 2011, the HOME initiative conducted a consensus study involving 43 individuals from 10 countries, representing different stakeholders (patients, clinicians, methodologists, pharmaceutical industry) to determine core outcome domains for atopic eczema trials, to define quality criteria for atopic eczema outcome measures and to prioritize topics for atopic eczema outcomes research. Delegates were given evidence-based information, followed by structured group discussion and anonymous consensus voting. Consensus was achieved to include clinical signs, symptoms, long-term control of flares and quality of life into the core set of outcome domains for atopic eczema trials. The HOME initiative strongly recommends including and reporting these core outcome domains as primary or secondary endpoints in all future atopic eczema trials. Measures of these core outcome domains need to be valid, sensitive to change and feasible. Prioritized topics of the HOME initiative are the identification/development of the most appropriate instruments for the four core outcome domains. HOME is open to anyone with an interest in atopic eczema outcomes research.
在特应性皮炎临床试验中使用非标准化和验证不足的结局测量方法是实践循证皮肤病学的主要障碍。特应性皮炎结局测量协调(HOME)倡议是一个国际多专业小组,致力于特应性皮炎结局研究。2011 年 6 月,HOME 倡议进行了一项共识研究,涉及来自 10 个国家的 43 名代表,代表不同的利益相关者(患者、临床医生、方法学家、制药行业),以确定特应性皮炎临床试验的核心结局领域,定义特应性皮炎结局测量的质量标准,并为特应性皮炎结局研究确定优先事项。代表们收到了基于证据的信息,然后进行了结构化的小组讨论和匿名共识投票。达成共识,将临床体征、症状、发作的长期控制和生活质量纳入特应性皮炎临床试验的核心结局领域。HOME 倡议强烈建议将这些核心结局领域作为特应性皮炎临床试验的主要或次要终点进行包括和报告。这些核心结局领域的测量方法需要具有有效性、对变化敏感和可行性。HOME 倡议的优先事项是确定/开发适用于四个核心结局领域的最适当工具。HOME 向所有对特应性皮炎结局研究感兴趣的人开放。