Centre for Evidence-based Healthcare, University Hospital Dresden, Dresden, Germany; Institute and Policlinic of Occupational and Social Medicine, Technical University Dresden, Dresden, Germany.
J Allergy Clin Immunol. 2013 Dec;132(6):1337-47. doi: 10.1016/j.jaci.2013.07.008. Epub 2013 Sep 12.
Clinical signs are a core outcome domain for atopic dermatitis (AD) trials. The current lack of standardization of outcome measures in AD trials hampers evidence-based communication.
We sought to provide evidence-based recommendations for the measurement of clinical signs in AD trials and to inform the Harmonising Outcome Measures for Atopic Dermatitis Initiative.
We conducted a systematic review on measurement properties of outcome measurements for clinical signs of AD. We systematically searched MEDLINE and Embase (until October 1, 2012) for validation studies on instruments measuring the clinical signs of AD. Grading of the truth, discrimination, and feasibility of scales; methodological study quality; and recommendations were based on predefined criteria.
Sixteen eligible instruments were identified, of which 2 were best validated. The Eczema Area and Severity Index has adequate validity, responsiveness, internal consistency, intraobserver reliability, and intermediate interobserver reliability but unclear interpretability and feasibility. The Severity Scoring of Atopic Dermatitis Index (SCORAD) has adequate validity, responsiveness, interobserver reliability, and interpretability and unclear intraobserver reliability. Only the objective SCORAD (ie, the clinical signs domain of the SCORAD) is internally consistent. The Six Area, Six Sign Atopic Dermatitis Index severity score and Three Item Severity Score fulfill some quality criteria, but the performance in other required measurement properties is unclear. The Patient-oriented Eczema Measure is reliable and responsive but has inadequate content validity to assess clinical signs of AD. The remaining 11 scales have either (almost) not been validated or performed inadequately.
The Eczema Area and Severity Index and SCORAD are the best instruments to assess the clinical signs of AD. The other 14 instruments identified are (currently) not recommended because of unclear or inadequate measurement properties.
临床体征是特应性皮炎（AD）试验的核心结局领域。目前 AD 试验中结局测量方法缺乏标准化，阻碍了循证交流。
我们旨在为 AD 试验中临床体征的测量提供循证建议，并为特应性皮炎结局测量协调倡议提供信息。
我们对 AD 临床体征结局测量的方法学特性进行了系统评价。我们系统地检索了 MEDLINE 和 Embase（截至 2012 年 10 月 1 日），以获取评估 AD 临床体征的工具的验证研究。量表的真实性分级、区分度和可行性；方法学研究质量；以及推荐意见均基于预先设定的标准。
确定了 16 项合格的工具，其中 2 项被认为是最佳验证的。Eczema Area and Severity Index（EASI）具有充分的有效性、反应度、内部一致性、观察者间信度和中等的观察者内信度，但可解释性和可行性尚不清楚。Severity Scoring of Atopic Dermatitis Index（SCORAD）具有充分的有效性、反应度、观察者间信度和可解释性，以及尚不清楚的观察者内信度。只有客观的 SCORAD（即 SCORAD 的临床体征域）具有内部一致性。Six Area, Six Sign Atopic Dermatitis Index 严重度评分和 Three Item Severity Score 符合一些质量标准，但在其他所需的测量特性方面的表现尚不清楚。Patient-oriented Eczema Measure 具有可靠性和反应度，但评估 AD 临床体征的内容效度不足。其余 11 种量表要么（几乎）未经验证，要么表现不佳。
EASI 和 SCORAD 是评估 AD 临床体征的最佳工具。确定的其他 14 种工具因测量特性不明确或不充分而不推荐使用。
