Core Outcome Measures in Effectiveness Trials

Evaluation of the measurement properties of symptom measurement instruments for atopic eczema: a systematic review

General Information

Abstract:
BACKGROUND: Symptoms have been identified as a core outcome domain for atopic eczema (AE) trials. Various instruments exist to measure symptoms in AE, but they vary in quality and there is a lack of standardization between clinical trials. Our objective was to systematically evaluate the quality of the evidence on the measurement properties of AE symptom instruments, thereby informing consensus discussions within the Harmonising Outcome Measures for Eczema (HOME) initiative regarding the most appropriate instruments for the core outcome domain symptoms. METHODS: Using the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklist and predefined criteria for good measurement properties on identified development and validation studies of AE symptom instruments, a best evidence synthesis was performed to draw an overall conclusion on quality of the instruments and to provide recommendations. RESULTS: Eighteen instruments were identified and evaluated. When the quality and results of the studies were considered, only five of these instruments had sufficient validation data to consider them for the core outcome set for the core outcome domain symptoms. These were the paediatric Itch Severity Scale (ISS), Patient-Oriented Eczema Measure (POEM), Patient-Oriented SCOring Atopic Dermatitis (PO-SCORAD), Self-Administered Eczema Area and Severity Index (SA-EASI) and adapted SA-EASI. CONCLUSIONS: ISS (paediatric version), POEM, PO-SCORAD, SA-EASI and adapted SA-EASI are currently the most appropriate instruments and therefore have the potential to be recommended as core symptom instrument in future clinical trials. These findings will be utilized for the development of a core outcome set for AE.

Authors:
Gerbens, L. A. Prinsen, C. A. Chalmers, J. R. Drucker, A. M. von Kobyletzki, L. B. Limpens, J. Nankervis, H. Svensson, A. Terwee, C. B. Zhang, J. Apfelbacher, C. J. Spuls, P. I. Harmonising Outcome Measures for Eczema, initiative

Publication

Journal:
Allergy
Volume:
72
Issue:
1
Pages:
146 - 163
Year:
2017
DOI:
Further Study Information

Date:
August 2015
Funding source(s):

Health Area

Disease Category
Skin

Disease Name
Eczema

Target Population

Age Range
-

Sex
Either


Nature / type of Intervention
Not specified

Method(s)

Systematic review

Stakeholders Involved

None

Study Type

Recommended outcome measures (measurement)
Systematic review of outcome measures/measurement instruments

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