Dataset Information

A comparison between self-reported hand eczema and self-reported signs and symptoms of skin lesions indicating hand eczema.

ABSTRACT:

Background

The accuracy of self-reported hand eczema (HE) is currently unclear, and it is unknown how well self-reported signs and symptoms of skin lesions that indicate HE correlate with self-reported HE.

Objectives

To correlate self-reported signs and symptoms of skin lesions on the hands with self-reported HE, to assess the sensitivity and specificity, and to suggest a definition for HE.

Method

Seven hundred ninety-five (47.8%) of 1663 invited healthcare workers completed a digital questionnaire, and were asked to report if they experienced HE or any of the following skin signs/symptoms in past 11 months: scaling, erythema, fissures, vesicles, dryness, itch, stinging.

Results

HE during the past 11 months was reported by 11.9%. Of these, 91.4% reported at least one skin sign versus 32.3% of those without self-reported HE. The highest sensitivity and specificity were found for erythema (77.4% and 78.2%, respectively) and itch (78.5% and 78.6%, respectively), both separately and combined. The combination of ≥2 signs (erythema, scaling, fissures and vesicles) and itch, reached a sensitivity of 52.7% and specificity of 93.9%.

Conclusion

The marked difference between self-reported HE and signs/symptoms highlights the importance of differentiating between data based on self-reported HE and signs/symptoms. As a first step towards diagnostic HE criteria, ≥2 signs combined with itch could be considered, but clinical studies are needed to verify the precision.

SUBMITTER: Yuksel YT

PROVIDER: S-EPMC9796092 | biostudies-literature | 2022 Dec

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

A comparison between self-reported hand eczema and self-reported signs and symptoms of skin lesions indicating hand eczema.

Yüksel Yasemin Topal YT Thyssen Jacob P JP Nørreslet Line Brok LB Flachs Esben Meulengracht EM Ebbehøj Niels Erik NE Agner Tove T

Contact dermatitis 20220721 6

<h4>Background</h4>The accuracy of self-reported hand eczema (HE) is currently unclear, and it is unknown how well self-reported signs and symptoms of skin lesions that indicate HE correlate with self-reported HE.<h4>Objectives</h4>To correlate self-reported signs and symptoms of skin lesions on the hands with self-reported HE, to assess the sensitivity and specificity, and to suggest a definition for HE.<h4>Method</h4>Seven hundred ninety-five (47.8%) of 1663 invited healthcare workers complete ...[more]

PMID: 35808939

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Project description:IntroductionChronic Hand Eczema (CHE) is an inflammatory skin disease of the hands. The Hand Eczema Symptom Diary (HESD) is a new patient-reported outcome measure of worst severity of core CHE signs/symptoms. This study aimed to evaluate content and psychometric validity of the HESD.MethodsThe HESD was developed based on the literature and concept elicitation interviews. Qualitative cognitive debriefing interviews were conducted with CHE patients to assess relevance and understanding of items, response options and recall period. Psychometric properties of the HESD (item performance, dimensionality, reliability, validity, responsiveness and estimation of meaningful change thresholds) were then assessed, first using data from a phase 2b trial (NCT03683719), and confirmed using data from the first 280 participants completing the 16-week treatment phase of a phase 3 trial (NCT04871711).ResultsCognitive debriefing supported item refinement and removal of items and confirmed all items were well understood and relevant to patients. Item properties and dimensionality analyses in the phase 2b data supported removal of additional items, resulting in the 6-item HESD included in the phase 3 trial. Unidimensionality was supported by inter-item correlations (all > 0.70) and Rasch analysis. Internal consistency (Cronbach's alpha = 0.96) and test-retest reliability (Intraclass Correlation Coefficient > 0.89) results were very strong. Construct validity was supported by moderate correlations with concurrent measures (0.53-0.64) and significant differences between severity groups (p < 0.001). Large effect sizes for mean change scores in participants that improved and significant differences between change groups indicated the ability to detect change. Anchor-based analyses supported within-individual responder definitions of ≥ 4-points for improvements in 7-day average HESD scores.ConclusionThe HESD is the first CHE-specific, patient-reported outcome measure of CHE signs/symptoms developed and validated in line with regulatory guidance. This article provides evidence of strong content validity and psychometric validity and shows improvements of ≥ 4 points on 7-day average HESD scores represent clinically meaningful, important changes.Trial registrationNCT03683719, NCT04871711.

Project description:Patient-reported outcome measures (PROMs) provide an important complement to physician-assessed clinical outcome measures in dermatologic diseases such as atopic dermatitis (AD) and chronic hand eczema (CHE). AD and CHE are chronic and relapsing inflammatory skin conditions that often co-occur. While both diseases result in various signs and symptoms that are burdensome and can negatively affect patients' lives, there may be distinct differences in the signs, symptoms, burden, and health-related quality of life (HRQOL) impact of these diseases. The objective of this study was to identify and evaluate PROMs used in studies of AD and CHE. The aim was to explore the assessment of key symptoms and impacts, and identify any gaps in the measures in use. A structured review of the PubMed database was conducted to identify PROMs used or developed for use in AD or CHE. The Dermatology Life Quality Index (DLQI), the Pruritus/Itch Numeric Rating Scale (NRS), the Patient-Oriented Eczema Measure (POEM), and the Quality of Life in Hand Eczema Questionnaire (QOLHEQ) were identified and reviewed in detail. With these measures, the AD and CHE symptoms and impacts most commonly evaluated in the literature include dermatology-related HRQOL in the domains of symptoms and feelings, daily activities, leisure, work and school, personal relationships, and adverse effects; pruritus; sleep disturbance; AD-specific symptoms (dryness, itching, flaking, cracking, bleeding, and weeping/oozing); and CHE-specific symptoms (pain, itch, fissuring, redness, bleeding, and dryness). A review of regulatory labels of drugs approved for AD by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) found that, among the four measures reviewed, the Pruritus NRS was included in the FDA and EMA labels for dupilumab, the DLQI was included in the EMA labels for dupilumab and tacrolimus, and the POEM was included in the EMA label for dupilumab. Key symptoms of AD (e.g. itching, flaking, cracking) and CHE (e.g. pain, itching, fissuring) are increasingly being assessed with PROMs; however, primary endpoints in clinical trials are often based on clinician-reported outcome measures. As therapeutic strategies in dermatology are targeted at specific dermatologic symptoms and diseases affecting specific sites (e.g. CHE), future research should explore patients' experiences with these symptoms and sites and the changes with treatment that are most meaningful to them.

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Dataset Information

A comparison between self-reported hand eczema and self-reported signs and symptoms of skin lesions indicating hand eczema.

Background

Objectives

Method

Results

Conclusion

Publications

A comparison between self-reported hand eczema and self-reported signs and symptoms of skin lesions indicating hand eczema.

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