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Assessment of clinical signs of atopic dermatitis: a systematic review and recommendation.
J Allergy Clin Immunol. 2013 Dec; 132(6):1337-47.JA

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+Show Affiliations

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.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Research Support, Non-U.S. Gov't
Review
Systematic Review

Language

eng

PubMed ID

24035157

Citation

Schmitt, Jochen, et al. "Assessment of Clinical Signs of Atopic Dermatitis: a Systematic Review and Recommendation." The Journal of Allergy and Clinical Immunology, vol. 132, no. 6, 2013, pp. 1337-47.
Schmitt J, Langan S, Deckert S, et al. Assessment of clinical signs of atopic dermatitis: a systematic review and recommendation. J Allergy Clin Immunol. 2013;132(6):1337-47.
Schmitt, J., Langan, S., Deckert, S., Svensson, A., von Kobyletzki, L., Thomas, K., & Spuls, P. (2013). Assessment of clinical signs of atopic dermatitis: a systematic review and recommendation. The Journal of Allergy and Clinical Immunology, 132(6), 1337-47. https://doi.org/10.1016/j.jaci.2013.07.008
Schmitt J, et al. Assessment of Clinical Signs of Atopic Dermatitis: a Systematic Review and Recommendation. J Allergy Clin Immunol. 2013;132(6):1337-47. PubMed PMID: 24035157.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Assessment of clinical signs of atopic dermatitis: a systematic review and recommendation. AU - Schmitt,Jochen, AU - Langan,Sinéad, AU - Deckert,Stefanie, AU - Svensson,Ake, AU - von Kobyletzki,Laura, AU - Thomas,Kim, AU - Spuls,Phyllis, AU - ,, Y1 - 2013/09/12/ PY - 2013/05/03/received PY - 2013/07/11/revised PY - 2013/07/11/accepted PY - 2013/9/17/entrez PY - 2013/9/17/pubmed PY - 2014/2/12/medline KW - AD KW - Atopic dermatitis KW - BSA KW - Body surface area KW - COSMIN KW - Consensus-based Standards for the Selection of Health Measurement Instruments KW - EASI KW - Eczema Area and Severity Index KW - HOME KW - Objective Scoring Atopic Dermatitis Index KW - PO-SCORAD KW - POEM KW - Patient-oriented Eczema Measure KW - Patient-oriented Scoring Atopic Dermatitis Index KW - SA-EASI KW - SASSAD KW - SCORAD KW - Scoring Atopic Dermatitis Index KW - Self-administered Eczema Area and Severity Index KW - Six Area, Six Sign Atopic Dermatitis Index KW - TIS KW - The Harmonising Outcome Measures for Eczema Initiative KW - Three Item Severity Score KW - evidence-based medicine KW - oSCORAD KW - reliability KW - responsiveness KW - severity of illness index KW - systematic review KW - validity SP - 1337 EP - 47 JF - The Journal of allergy and clinical immunology JO - J Allergy Clin Immunol VL - 132 IS - 6 N2 - 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. SN - 1097-6825 UR - https://www.unboundmedicine.com/medline/citation/24035157/Assessment_of_clinical_signs_of_atopic_dermatitis:_a_systematic_review_and_recommendation_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0091-6749(13)01068-3 DB - PRIME DP - Unbound Medicine ER -