Evidence map›Paper›PMID 39396828›Full record

Trial reportContact dermatitis2025

Evaluation of validity, reliability and ability to detect change for the Hand Eczema Severity Index (HECSI) and evaluation of HECSI-75 and HECSI-90 as within-patient responder definitions.

Yasemin Topal Yüksel, Henrik Thoning, Lotte Seiding Larsen, Lucine Lehmann, Rob Arbuckle, Laura Grant, Tove Agner

Abstract readRandomized Controlled TrialValidation StudyClinical Trial, Phase II
In one paragraph

Trial report in Contact dermatitis, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing 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

6 citing papers in PubMed.

  1. Trial
  2. Article
  3. Article
  4. Article
  5. Review
  6. Article
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.

Yasemin Topal YükselDepartment of Dermatology and Venereology, Bispebjerg Hospital, University of Copenhagen, Copenhagen, Denmark.ORCID https://orcid.org/0000-0003-1289-1827
Henrik ThoningLEO Pharma A/S, Ballerup, Denmark.
Lotte Seiding LarsenLEO Pharma A/S, Ballerup, Denmark.
Lucine LehmannLEO Pharma A/S, Ballerup, Denmark.
Rob ArbuckleAdelphi Values Patient-Centered Outcomes, Cheshire, UK.ORCID https://orcid.org/0000-0003-0345-2523
Laura GrantAdelphi Values Patient-Centered Outcomes, Cheshire, UK.
Tove AgnerDepartment of Dermatology and Venereology, Bispebjerg Hospital, University of Copenhagen, Copenhagen, Denmark.ORCID https://orcid.org/0000-0002-7543-8299

Funding

LEO Pharma
6 · The paper itself

Abstract

backgroundThe Hand Eczema Severity Index (HECSI) is a Clinician-Reported Outcome measure of the severity of hand eczema (HE).

objectivesThis study aimed to evaluate the validity, reliability and ability to detect change of the HECSI, and the HECSI-75 and HECSI-90 as responder definitions.

methodsAnalyses were performed using data from a sample of n = 258 patients with Chronic Hand Eczema (CHE) from a Phase 2b, randomised, double-blind, vehicle-controlled trial of delgocitinib cream, pooled across treatment groups. The measurement properties of the HECSI were assessed and the adequacy of the HECSI-75 and HECSI-90 as responder definitions was explored through cross-tabulation.

resultsInter-item correlations provided support for the scoring, whereby items are grouped by areas of the hand. HECSI demonstrated good test-retest reliability with intra-class correlations >0.70. Construct validity was supported by a logical pattern of correlations with concurrent measures and significant differences in HECSI scores across severity groups (p < 0.001). HECSI was responsive with statistically significant improvements over time and with significant differences (p < 0.001) between improved and stable groups. Data provided support for both HECSI-75 and HECSI-90 as within-patient responder definitions.

conclusionsHECSI has strong validity, reliability and ability to detect change as a measure of CHE severity. HECSI-75 and HECSI-90 are appropriate responder definitions.

Indexed as

Hand DermatosesSeverity of Illness IndexAdultDouble-Blind MethodEczemaFemaleHumansMaleMiddle AgedReproducibility of ResultsChronic Hand EczemaClinician‐Reported Outcomedelgocitinib creamHECSI‐75HECSI‐90meaningful changeresponder definitionvalidation

Identifiers

PMID39396828
PMCPMC11669562

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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.