title: Assessment of clinical signs of atopic dermatitis: a systematic review and recommendation.
abstract: BACKGROUND
  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.
  
  
  OBJECTIVE
  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.
  
  
  METHODS
  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.
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Centre for Evidence-based Healthcare, University Hospital Dresden, Dresden, Germany; Institute and Policlinic of Occupational and Social Medicine, Technical University Dresden, Dresden, Germany. Electronic address: jochen.schmitt@uniklinikum-dresden.de.
authors.forename: Jochen
authors.initials: J
authors.lastname: Schmitt
authors.forename: Sinéad
authors.initials: S
authors.lastname: Langan
authors.forename: Stefanie
authors.initials: S
authors.lastname: Deckert
authors.forename: Ake
authors.initials: A
authors.lastname: Svensson
authors.forename: Laura
authors.initials: L
authors.lastname: von Kobyletzki
authors.forename: Kim
authors.initials: K
authors.lastname: Thomas
authors.forename: Phyllis
authors.initials: P
authors.lastname: Spuls
mesh_terms: D000818:Animals; D002986:Clinical Trials as Topic; D003876:Dermatitis, Atopic / Q000175:diagnosis* / Q000276:immunology; D019317:Evidence-Based Medicine; D006801:Humans; D015588:Observer Variation; D017410:Practice Guidelines as Topic; D015203:Reproducibility of Results; D012720:Severity of Illness Index
keywords: AD; Atopic dermatitis; BSA; Body surface area; COSMIN; Consensus-based Standards for the Selection of Health Measurement Instruments; EASI; Eczema Area and Severity Index; HOME; Objective Scoring Atopic Dermatitis Index; PO-SCORAD; POEM; Patient-oriented Eczema Measure; Patient-oriented Scoring Atopic Dermatitis Index; SA-EASI; SASSAD; SCORAD; Scoring Atopic Dermatitis Index; Self-administered Eczema Area and Severity Index; Six Area, Six Sign Atopic Dermatitis Index; TIS; The Harmonising Outcome Measures for Eczema Initiative; Three Item Severity Score; evidence-based medicine; oSCORAD; reliability; responsiveness; severity of illness index; systematic review; validity