Evidence map›Paper›PMID 33393074›Full record

ArticleThe British journal of dermatology2021

Recommended core outcome instruments for health-related quality of life, long-term control and itch intensity in atopic eczema trials: results of the HOME VII consensus meeting.

K S Thomas, C A Apfelbacher, J R Chalmers, E Simpson, P I Spuls, L A A Gerbens, H C Williams, J Schmitt, M Gabes, L Howells and 12 more

Abstract readConsensus Statement
PubMed Full text at PMC Publisher
In one paragraph

Article in The British journal of dermatology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 27 papers.

0numbers the graph read from it
0cells of the map it votes in
27citing papers in PubMed
–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

27 citing papers in PubMed.

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  17. Review
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  19. DESCRIBE-AD: A novel classification framework for atopic dermatitis.Journal of the American Academy of Dermatology · 2022
    Review
  20. Risk factors for food sensitization in children with atopic dermatitis: a single-center cross-sectional study.Zhongguo dang dai er ke za zhi = Chinese journal of contemporary pediatrics · 2022
    Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

22 authors.

K S ThomasCentre of Evidence Based Dermatology, School of Medicine, Nottingham, UK.ORCID 0000-0001-7785-7465
C A ApfelbacherInstitute of Social Medicine and Health Systems Research (ISMHSR), Otto von Guericke University Magdeburg, Magdeburg, Germany.ORCID 0000-0003-3805-8219
J R ChalmersCentre of Evidence Based Dermatology, School of Medicine, Nottingham, UK.ORCID 0000-0002-2281-7367
E SimpsonDepartment of Dermatology, Oregon Health & Science University, Portland, OR, USA.ORCID 0000-0002-8793-7087
P I SpulsDepartment of Dermatology, Amsterdam Public Health, Infection and Immunity, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.ORCID 0000-0002-6035-2863
L A A GerbensDepartment of Dermatology, Amsterdam Public Health, Infection and Immunity, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.ORCID 0000-0002-5244-5058
H C WilliamsCentre of Evidence Based Dermatology, School of Medicine, Nottingham, UK.ORCID 0000-0002-5646-3093
J SchmittCenter for Evidence-based Healthcare, Medical Faculty Carl Gustav Carus, Dresden, Germany.ORCID 0000-0003-0264-0960
M GabesMedical Sociology, Department of Epidemiology and Preventive Medicine, University of Regensburg, Regensburg, Germany.ORCID 0000-0003-1672-7549
L HowellsCentre of Evidence Based Dermatology, School of Medicine, Nottingham, UK.ORCID 0000-0003-4157-7394
B L StuartPrimary Care, Population Sciences and Medical Education, Faculty of Medicine, University of Southampton, Southampton, UK.ORCID 0000-0001-5432-7437
E GrinichSchool of Medicine (Department of Dermatology), Oregon Health & Science University, Portland, OR, USA.ORCID 0000-0002-5125-2617
T PawlitschekSchool of Medicine (Department of Dermatology), Oregon Health & Science University, Portland, OR, USA.ORCID 0000-0002-4812-012X
T BurtonPatient representative (independent), Nottingham, UK.
L HowieGlobal Parents for Eczema Research, Brisbane, Australia.
A GadkariHealth Economics and Outcomes Research, Boehringer Ingelheim Inc., Ingelheim, Rheinland-Pfalz, Germany.
L EckertGlobal Dupixent Business Partner, sanofi GHEVA, 1 av. Pierre Brossolette, Chilly-Mazarin, 91380, France.ORCID 0000-0002-7801-4125
T EbataChitofuna Dermatology Clinic, Tokyo, Japan.
M BoersDepartment of Epidemiology and Data Science, Amsterdam Rheumatology and Immunology Center, Amsterdam UMC, Vrije Universiteit, Amsterdam, the Netherlands.ORCID 0000-0002-6969-283X
H SaekiDepartment of Dermatology, Nippon Medical School, 1-1-5 Sendagi, Bunkyo-ku, Tokyo, Japan.
T NakaharaDepartment of Dermatology, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.ORCID 0000-0003-2811-8273
N KatohDepartment of Dermatology, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kyoto, Japan.ORCID 0000-0002-3498-2482

Funding

British Skin Foundation 8016Japanese Dermatological AssociationKyoto Prefectural University of Medicine and Kyushu UniversityLydia O'Leary Memorial Pias Dermatological FoundationNakatomi FoundationNational Institute for Health ResearchUehara Memorial Foundation
6 · The paper itself

Abstract

backgroundThe Harmonising Outcome Measures for Eczema (HOME) initiative has established a core outcome set of domains for atopic eczema (AE) clinical trials. Previous consensus meetings have agreed on preferred instruments for clinician-reported signs (Eczema Area and Severity Index, EASI) and patient-reported symptoms (Patient-Oriented Eczema Measure, POEM). This paper reports consensus decisions from the HOME VII meeting.

objectivesTo complete the core outcome set for AE by agreeing on core outcome instruments for the domains of quality of life (QoL), long-term control and itch intensity.

methodsA face-to-face consensus meeting was held in Tokyo, Japan (8-10 April 2019) including 75 participants (49 healthcare professionals/methodologists, 14 patients, 12 industry representatives) from 16 countries. Consensus decisions were made by presentations of evidence, followed by whole and small group discussions and anonymous voting using predefined consensus rules.

resultsIt was agreed by consensus that QoL should be measured using the Dermatology Life Quality Index (DLQI) for adults, the Children's Dermatology Life Quality Index (CDLQI) for children and the Infant's Dermatology Quality of Life Index (IDQoL) for infants. For long-term control, the Recap of Atopic Eczema (RECAP) instrument or the Atopic Dermatitis Control Test (ADCT) should be used. Consensus was not reached over the frequency of data collection for long-term control. The peak itch numerical rating scale (NRS)-11 past 24 h was recommended as an additional instrument for the symptom domain in trials of older children and adults. Agreement was reached that all core outcome instruments should be captured at baseline and at the time of primary outcome assessment as a minimum.

conclusionsFor now, the core outcome set for clinical trials in AE is complete. The specified domains and instruments should be used in all new clinical trials and systematic reviews of eczema treatments.

Indexed as

Dermatitis, AtopicEczemaAdolescentAdultChildHumansInfantJapanOutcome Assessment, Health CareQuality of LifeSeverity of Illness Index

Identifiers

PMID33393074
PMCPMC8359383

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Registered trials

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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.