Validation of Treatment Escalation as a Definition of Atopic Eczema Flares
In: ISSN: 1932-6203, 2015
Online
academicJournal
Zugriff:
International audience ; 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.
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Validation of Treatment Escalation as a Definition of Atopic Eczema Flares
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Autor/in / Beteiligte Person: | Thomas, Kim ; Stuart, Beth ; O’leary, Caroline ; Schmitt, Jochen ; Paul, Carle ; Williams, Hywel ; Langan, Sinead ; University of Nottingham, UK (UON) ; University of Southampton ; Medical Research Council Clinical Trials Unit (MRC CTU) ; University College of London London (UCL) ; Medical Faculty - Carl Gustav Carus ; Université Toulouse III - Paul Sabatier (UT3) ; Université de Toulouse (UT) ; Faculty of Epidemiology and Population Health London ; London School of Hygiene and Tropical Medicine (LSHTM) |
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Zeitschrift: | ISSN: 1932-6203, 2015 |
Veröffentlichung: | HAL CCSD ; Public Library of Science, 2015 |
Medientyp: | academicJournal |
DOI: | 10.1371/journal.pone.0124770 |
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