Evidence map›Paper›PMID 25897763›Full record

Trial reportPloS one2015

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, Sinead Langan

Abstract readObservational StudyRandomized Controlled TrialValidation Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in PloS one, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 2 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Oral H1 antihistamines as 'add-on' therapy to topical treatment for eczema.The Cochrane database of systematic reviews · 2019
    Pooled it
  2. Emollients and moisturisers for eczema.The Cochrane database of systematic reviews · 2017
    Pooled it
  3. Trial
  4. Defining "Flares" in Atopic Dermatitis: A Narrative Review.American journal of clinical dermatology · 2025
    Review
  5. Review
  6. Article
  7. Article
  8. Article
  9. Article
  10. Article
  11. The Long-Term Course of Atopic Dermatitis.Dermatologic clinics · 2017
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors.

Kim S ThomasCentre of Evidence Based Dermatology, University of Nottingham, Nottingham, United Kingdom.
Beth StuartFaculty of Medicine, University of Southampton, Southampton, United Kingdom.
Caroline J O'LearyMRC Clinical Trials Unit, London, United Kingdom.
Jochen SchmittCentre of Evidence Based Dermatology, University of Nottingham, Nottingham, United Kingdom; Centre for Evidence-based Healthcare, Medical Faculty Carl Gustav Carus, TU Dresden, Germany.
Carle PaulINSERM 1056, Dermatology, Paul Sabatier University, Toulouse, France.
Hywel C WilliamsCentre of Evidence Based Dermatology, University of Nottingham, Nottingham, United Kingdom.
Sinead LanganFaculty of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, United Kingdom.

Funding

Department of Health NIHR/CS/010/014
6 · The paper itself

Abstract

backgroundAtopic 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.

objectiveTo 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).

methodsData 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.

resultsGood 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).

conclusionBoth 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 registrationCurrent Controlled Trials ISRCTN71423189 (Study A).

Indexed as

Symptom Flare UpAdministration, CutaneousAdolescentAdrenal Cortex HormonesAnti-Inflammatory AgentsArea Under CurveCalcineurin InhibitorsChildChild, PreschoolDermatitis, AtopicDermatologic AgentsDrug Administration ScheduleFemaleHumansInfantMaleAdrenal Cortex HormonesAnti-Inflammatory AgentsCalcineurin InhibitorsDermatologic Agents

Identifiers

PMID25897763
PMCPMC4405584

What OpenQuestion holds

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LicenceCC BY
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.