Measuring long-term disease control in atopic dermatitis: a validation study of well controlled weeks
Measuring long-term disease control in atopic dermatitis: a validation study of well controlled weeks
Background Because atopic dermatitis (AD) is a relapsing, remitting disease, assessing long-term control is important. Well controlled weeks (WCWs) have been used to assess asthma long-term control, but never validated for AD. Objectives: To assess feasibility, validity and interpretability of WCWs in AD patients.
Methods Three studies of patients with moderate-to-severe AD including 4-6 months of daily/weekly symptom and treatment use data were evaluated (Study A: n=336; Study B: n=60; Study C: n=224). WCWs were defined by worsening symptoms and increased medication use. Feasibility, construct validity and interpretability of WCWs were determined by assessing missing data, association with validated AD outcomes, and floor/ceiling effects. Analysis used linear and logistic regression.
Results WCWs were feasible to collect - 95.2% (study A) and 94.7% (study B) contributed data for at least half of the weekly data-points, and 93.2% and 88.7% contributed to all data-points up to 4 months. WCWs were significantly associated with validated AD severity instruments including patient-reported (POEM) and objective signs (EASI, TIS and SASSAD). The odds of experiencing a WCW if AD severity was clear/mild was 5.8 (95% confidence interval (CI) 3.5 to 9.7), 1.9 (95%CI 0.8 to 4.4) and 8.1 (95%CI 4.5 to 14.6) in Studies A, B and C, respectively. WCWs were associated with ceiling effects- 31.6% (study A) and 37.5% (study B) of participants had no WCWs for >90% of the time.
Conclusions WCWs are valid and feasible for measuring long-term control in AD trials. However, ceiling effects and burden of data collection may limit use.
1580-1586
Langan, Sinead M
34b0a654-2b99-424a-893a-f4b5eee197ee
Stuart, Beth
626862fc-892b-4f6d-9cbb-7a8d7172b209
Bradshaw, Lucy
803184fe-23e7-497c-a1e8-a79d22359c25
Schmitt, Jochen
cfa055d1-9a2e-4d7c-a57a-78517ee5372b
Williams, Hywel C.
3914e691-2348-4704-a044-e8d2af92444e
Thomas, Kim S
b3bc044e-811d-4dcb-ad36-7c6018c4bb04
December 2017
Langan, Sinead M
34b0a654-2b99-424a-893a-f4b5eee197ee
Stuart, Beth
626862fc-892b-4f6d-9cbb-7a8d7172b209
Bradshaw, Lucy
803184fe-23e7-497c-a1e8-a79d22359c25
Schmitt, Jochen
cfa055d1-9a2e-4d7c-a57a-78517ee5372b
Williams, Hywel C.
3914e691-2348-4704-a044-e8d2af92444e
Thomas, Kim S
b3bc044e-811d-4dcb-ad36-7c6018c4bb04
Langan, Sinead M, Stuart, Beth, Bradshaw, Lucy, Schmitt, Jochen, Williams, Hywel C. and Thomas, Kim S
(2017)
Measuring long-term disease control in atopic dermatitis: a validation study of well controlled weeks.
Journal of Allergy and Clinical Immunology, 140 (6), .
(doi:10.1016/j.jaci.2017.02.043).
Abstract
Background Because atopic dermatitis (AD) is a relapsing, remitting disease, assessing long-term control is important. Well controlled weeks (WCWs) have been used to assess asthma long-term control, but never validated for AD. Objectives: To assess feasibility, validity and interpretability of WCWs in AD patients.
Methods Three studies of patients with moderate-to-severe AD including 4-6 months of daily/weekly symptom and treatment use data were evaluated (Study A: n=336; Study B: n=60; Study C: n=224). WCWs were defined by worsening symptoms and increased medication use. Feasibility, construct validity and interpretability of WCWs were determined by assessing missing data, association with validated AD outcomes, and floor/ceiling effects. Analysis used linear and logistic regression.
Results WCWs were feasible to collect - 95.2% (study A) and 94.7% (study B) contributed data for at least half of the weekly data-points, and 93.2% and 88.7% contributed to all data-points up to 4 months. WCWs were significantly associated with validated AD severity instruments including patient-reported (POEM) and objective signs (EASI, TIS and SASSAD). The odds of experiencing a WCW if AD severity was clear/mild was 5.8 (95% confidence interval (CI) 3.5 to 9.7), 1.9 (95%CI 0.8 to 4.4) and 8.1 (95%CI 4.5 to 14.6) in Studies A, B and C, respectively. WCWs were associated with ceiling effects- 31.6% (study A) and 37.5% (study B) of participants had no WCWs for >90% of the time.
Conclusions WCWs are valid and feasible for measuring long-term control in AD trials. However, ceiling effects and burden of data collection may limit use.
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WCW validation_jan23_accepted
- Accepted Manuscript
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Accepted/In Press date: 10 February 2017
e-pub ahead of print date: 26 April 2017
Published date: December 2017
Organisations:
Primary Care & Population Sciences
Identifiers
Local EPrints ID: 407620
URI: http://eprints.soton.ac.uk/id/eprint/407620
ISSN: 0091-6749
PURE UUID: 18d92c45-90aa-4136-bacd-1963da8be028
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Date deposited: 16 Apr 2017 17:05
Last modified: 16 Mar 2024 05:08
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Contributors
Author:
Sinead M Langan
Author:
Lucy Bradshaw
Author:
Jochen Schmitt
Author:
Hywel C. Williams
Author:
Kim S Thomas
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