Atopic dermatitis and skin disease
Assessment of clinical signs of atopic dermatitis: A systematic review and recommendation

https://doi.org/10.1016/j.jaci.2013.07.008Get rights and content

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.

Section snippets

Methods

We conducted a systematic review on the measurement properties of outcome measures for clinical signs of AD according to an a priori study protocol. The protocol of our review was registered in the international prospective register of systematic reviews (PROSPERO; registration no. CRD42013003935, http://www.crd.york.ac.uk/PROSPERO/display_record.asp?ID=CRD42013003935).

Results

We identified 45 eligible articles.7, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63 Of these, 43 studies were identified by means of electronic search, and 2 studies47, 57 were identified through hand search. The flow diagram (Fig 1)64 provides information on study identification and the selection process. Table E2 in this article's Online Repository at //www.jacionline.org

Discussion

This systematic review identified, summarized, and critically appraised 16 different outcome measures to assess the severity of clinical signs of AD. Although none of these instruments completely met all the predefined criteria for adequate truth, discrimination, and feasibility, substantial validation work has been undertaken since our previous review.7

The EASI54 and SCORAD32 are the best instruments available to measure clinical signs of AD.

The SCORAD is a valid, internally consistent,

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    This publication describes work conducted on behalf of the Harmonising Outcome Measures for Atopic Dermatitis (HOME) Initiative, which is supported through an independent research grant funded by the National Institute for Health Research (NIHR) under its Programme Grants for Applied Research funding scheme (RP-PG-0407-10177). The views expressed in this publication are those of the author or authors and not necessarily those of the National Health Service, the NIHR, or the Department of Health.

    Disclosure of potential conflict of interest: S. Langan has received one or more grants from or has one or more grants pending with the National Institute for Health Research (NIHR; UK Department of Health). L. von Kobyletzki is a Board member for 100000DK, is employed by 1560000SEK, and has received one or more grants from or has one or more grants pending with 452500SEK. K. Thomas has been supported by an NIHR Programme Grant for Applied Research. The rest of the authors declare that they have no relevant conflicts of interest.

    These authors contributed equally to this work.

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