Validation of Treatment Escalation as a Definition of Atopic Eczema Flares

Kim S Thomas, Beth Stuart, Caroline J O’Leary, Jochen Schmitt, Carle Paul, Hywel C Williams and Sinead Langan

PLOS ONE, 2015, vol. 10, issue 4, 1-13

Abstract: Background: Atopic eczema (AE) is a chronic disease with flares and remissions. Long-term control of AE flares has been identified as a core outcome domain for AE trials. However, it is unclear how flares should be defined and measured. Objective: To validate two concepts of AE flares based on daily reports of topical medication use: (i) escalation of treatment and (ii) days of topical anti-inflammatory medication use (topical corticosteroids and/or calcineurin inhibitors). Methods: Data from two published AE studies (studies A (n=336) and B (n=60)) were analysed separately. Validity and feasibility of flare definitions were assessed using daily global bother (scale 0 to 10) as the reference standard. Intra-class correlations were reported for continuous variables, and odds ratios and area under the receiver operator characteristic (ROC) curve for binary outcome measures. Results: Good agreement was found between both AE flare definitions and change in global bother: area under the ROC curve for treatment escalation of 0.70 and 0.73 in studies A and B respectively, and area under the ROC curve of 0.69 for topical anti-inflammatory medication use (Study A only). Significant positive relationships were found between validated severity scales (POEM, SASSAD, TIS) and the duration of AE flares occurring in the previous week – POEM and SASSAD rose by half a point for each unit increase in number of days in flare. Smaller increases were observed on the TIS scale. Completeness of daily diaries was 95% for Study A and 60% for Study B over 16 weeks). Conclusion: Both definitions were good proxy indicators of AE flares. We found no evidence that ‘escalation of treatment’ was a better measure of AE flares than ‘use of topical anti-inflammatory medications’. Capturing disease flares in AE trials through daily recording of medication use is feasible and appears to be a good indicator of long-term control. Trial registration: Current Controlled Trials ISRCTN71423189 (Study A).

Date: 2015
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Persistent link: https://EconPapers.repec.org/RePEc:plo:pone00:0124770

DOI: 10.1371/journal.pone.0124770

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