Are accelerometers a useful tool for measuring disease activity in children with eczema? Validity, responsiveness to change, and acceptability of use in a clinical trial setting
Summary Background Actigraphy, which uses accelerometers to record movement, has been proposed as an objective method of itch assessment in eczema. Previous studies have found strong correlations with actigraphy and video surveillance, disease severity and biological markers in patients with eczema...
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Published in | British journal of dermatology (1951) Vol. 167; no. 5; pp. 1131 - 1137 |
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Main Authors | , , , , |
Format | Journal Article |
Language | English |
Published |
Oxford, UK
Blackwell Publishing Ltd
01.11.2012
Wiley-Blackwell |
Subjects | |
Online Access | Get full text |
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Summary: | Summary
Background Actigraphy, which uses accelerometers to record movement, has been proposed as an objective method of itch assessment in eczema. Previous studies have found strong correlations with actigraphy and video surveillance, disease severity and biological markers in patients with eczema.
Objectives To assess the validity of accelerometer data, its responsiveness to change and the practicality and acceptability of accelerometers when used as an outcome measure in a clinical trial.
Methods This study used data collected from 336 participants of the Softened Water Eczema Trial (SWET). Accelerometer data were compared with three standardized scales: Six Area, Six Sign Atopic Dermatitis (SASSAD) severity score, Patient Oriented Eczema Measure (POEM) and Dermatitis Family Impact (DFI). Spearman’s rank testing was used for correlations.
Results Only 70% of trial participants had complete data, compared with 96% for the primary outcome (eczema severity – SASSAD). The convergent validity of accelerometer data with other measures of eczema severity was poor: correlation with SASSAD 0·15 (P = 0·02) and POEM 0·10 (P = 0·13). Assessing for divergent validity against quality of life measures, the correlation with the DFI was low (r = 0·29, P < 0·0001). Comparing the change scores from baseline to week 12 for SASSAD, POEM and DFI with the change in accelerometer scores we found low, negative correlations (r = −0·02, P = 0·77; r = −0·12, P = 0·06; and r = −0·01, P = 0·87, respectively). In general, the units were well tolerated but suggestions were made that could improve their usability in children.
Conclusions Actigraphy did not correlate well with disease severity or quality of life when used as an objective outcome measure in a multicentre clinical trial, and was not responsive to change over time. Further work is needed to establish why this might be, and to establish improved methods of distinguishing between eczema‐related and eczema‐nonrelated movements. |
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Bibliography: | ark:/67375/WNG-L140VZL1-2 istex:EC6ADCBBE61530BFC6F85D8C49EB9FDCCB15E173 ArticleID:BJD11184 Trial registration: Current Controlled Trials ISRCTN71423189. Conflicts of interest None declared. Funding sources The SWET study was funded by the National Institute for Health Research (NIHR) Health Technology Assessment (HTA) programme (05/16/01). The views and opinions expressed in this article are those of the authors and do not necessarily reflect those of the NIHR HTA programme. Pilot work was supported through a grant from Nottingham University Hospitals Trust. ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-3 content type line 23 ObjectType-Undefined-2 |
ISSN: | 0007-0963 1365-2133 |
DOI: | 10.1111/j.1365-2133.2012.11184.x |