Validation of the Investigator Global Assessment of Chronic Hand Eczema (IGA-CHE): a new clinician reported outcome measure of CHE severity.

The Investigator Global Assessment of Chronic Hand Eczema (IGA-CHE) is a novel Clinician-Reported Outcome measure that allows investigators to assess cross-sectional CHE global disease severity using clinical characteristics of erythema, scaling, lichenification/hyperkeratosis, vesiculation, oedema, and fissures as guidelines for overall severity assessment. This study aimed to evaluate the psychometric properties of the IGA-CHE for use as an outcome measure in CHE clinical trials and clinical practice. Psychometric analyses were performed using data from a sample of 280 patients with moderate to severe CHE from a phase 3 trial of delgocitinib cream, pooled across treatment groups. Test-retest reliability results were moderate to strong with kappa coefficients ranging from 0.63 to 0.76. Correlations with measures assessing related concepts were moderate or strong (range 0.65-0.72) and exceeded a priori hypotheses, providing evidence of convergent validity. Known-groups validity was supported by statistically significant differences between severity groups (< 0.001). Within-group effect sizes were consistently larger for improved groups compared to stable groups, providing evidence of ability to detect change. Anchor-based analyses generated within-subject meaningful change estimates ranging from - 0.8 to - 2.3. A correlation weighted average suggested a single value of - 1.7 in change from baseline. These findings provide evidence the IGA-CHE scale has strong reliability, construct validity, and ability to detect change, supporting its use as an endpoint in CHE clinical trials and clinical practice. Based on the evidence, 2-level changes in IGA-CHE score are considered a conservative meaningful change threshold; however, findings also indicate 1-level change in IGA-CHE scores reflects a clinically meaningful improvement for patients.Clinical trial registration: NCT04871711.

Assessment of hand eczema severity by patients using the hand eczema severity index (HECSI).

BACKGROUND: Hand eczema severity index (HECSI) is a widely used tool for assessment of hand eczema (HE) severity. Generally, HECSI has been used by health care providers, and a validation of the HECSI tool when used by patients is lacking. OBJECTIVES: To evaluate the construct validity and reliability of HECSI as a tool for patients based on comparison to HECSI assessments by physicians. METHODS: Patients with HE, enrolled from the dermatological outpatient clinic, Bispebjerg Hospital, assessed HE severity with a patient version of HECSI (patient-HECSI). Afterwards, HECSI was assessed by a trained physician (physician-HECSI). RESULTS: This study found a strong correlation and very good absolute agreement between patient-HECSI and physician-HECSI assessments with a correlation coefficient of 0.756 and intraclass correlation coefficient (ICC) of 0.844. Cronbach's alpha was 0.861 indicating very good internal consistency. CONCLUSION: With a strong construct validity and reliability, the patient-HECSI may be used by patients as a patient-reported outcome assessing their personal HE severity.

Disease burden and treatment history among adults with atopic dermatitis receiving systemic therapy: baseline characteristics of participants on the EUROSTAD prospective observational study.

BACKGROUND: Insights into the real-world treatment paradigm and long-term burden of atopic dermatitis (AD) are needed to inform clinical and health policy decisions. METHODS: The prospective, observational EUROSTAD study enrolled adults with moderate-to-severe AD starting or switching systemic therapy (51 sites in 10 European countries). We report the baseline characteristics, treatment patterns, and outcomes of these patients using descriptive statistics. RESULTS: A 12-month enrollment period of EUROSTAD was completed and 308 patients were enrolled: average age 37 years, AD duration 25 years, 43% were female. Most patients reported use of systemic therapy (93%) and ≥1 atopic comorbidity (82%). Mean [standard deviation] disease severity/burden measures were high: Investigator's Global Assessment (3.1 [0.8]), Eczema Area and Severity Index (16.2 [10.9]), Peak Pruritus Numerical Rating Scale (5.5 [2.5]), sleep impairment Visual Analog Scale (49.8 [31.6]) scores, and time lost from work (4.1 [13.7] days/year) or usual activities (16.8 [38.7] days/year). Most patients showed borderline or clinical levels of anxiety (59%) and/or depression (63%) using the Hospital Anxiety and Depression Scale. CONCLUSIONS: Adults with moderate-to-severe AD starting/switching systemic treatment enrolled in EUROSTAD have a high burden of longstanding disease despite continuous use of topical drugs, emollients, and systemic therapies.

Value of photo assessment in late patch test readings-A multicenter study from six European patch test clinics.

BACKGROUND: It is recommended that patch test readings include a day (D)7 reading. Substitution of the D7 reading with a photo may be a valid option. OBJECTIVES: To compare the sensitivity of digital photos at D7 to clinical readings, to assess the number of positive reactions appearing at D7 only (late reactions), and after D7 only (delayed reactions). METHODS: Patients patch tested in six European clinics were instructed to forward photos of the patch test reactions to the respective clinics at D7 (before attending the clinic) and at D21. Only allergens in the baseline series or TRUE Test were included in the data analysis. RESULTS: Two hundred ninety-three of 629 patients had a total of 599 positive reactions, with 6.3% occurring at D7 only. When substituting the D7 reading with a photo (90% submitted), 26.3% of late reactions were missed and nine false-positive reactions were found. Delayed reactions were detected in four patients at D21 (65.3% submitted). CONCLUSION: Our data show that if the D7 reading is not performed, 6.3% of positive reactions from the baseline series would be missed, and if substituting the D7 reading by digital photo, 26.3% late reactions would be missed. Delayed reactions seemed rare.

Simple, low-cost group-counselling programme vs treatment as usual for patients with newly notified occupational hand eczema-Exploratory analyses of effects on knowledge, behaviour and personal resources of the randomized PREVEX clinical trial.

BACKGROUND: Sickness absence in hand eczema patients has been associated with stress rather than disease severity, indicating that personal aspects regarding hand eczema should be investigated further. OBJECTIVES: To examine whether patient education vs treatment as usual can influence behaviour and knowledge regarding skin protection and care, as well as personal resources, in patients with occupational hand eczema. METHODS: PREVEX is an individually randomized clinical trial investigating the 1-year effects of a simple, low-cost group-counselling programme vs treatment as usual for patients with notified occupational hand eczema. Exploratory outcomes were behaviour, knowledge, self-efficacy, and self-evaluated skin care ability. RESULTS: In total, 1668 patients with notified occupational skin disease were invited to participate, of whom 769 were randomized and 756 were analysed: intervention group (n = 376) vs control group (n = 380). Behaviour was improved and the knowledge score increased in the intervention group as compared with the control group (respectively: estimate 0.08; 95%CI: 0.02-0.19; P = .01; and estimate 0.49; 95%CI: 0.28-0.70; P < .001). Self-efficacy was lower in the intervention group as compared with the control group (estimate -0.78; 95%CI: -1.25 to -0.30; P = .001). No difference was found regarding skin care abilities. CONCLUSIONS: The intervention had a positive influence on 1-year behaviour and knowledge, but was insufficient to result in long-term positive changes in personal resources regarding dealing with hand eczema.

Photographic Documentation and Hand Eczema Severity Index for Severity Assessment of Hand Eczema.

BACKGROUND: Hand eczema (HE) is a fluctuating disease, and an objective assessment of HE severity is coveted. OBJECTIVES: This study was undertaken to test the association between Hand Eczema Severity Index (HECSI) score and panel scores of photographs taken by dermatologists. METHODS: A total of 33 patients with mild HE were included. The patients were part of an intervention study, and HECSI scores and standardized photographs were taken at baseline and at follow-up after 5 months. Actual change in HECSI score was compared with rating of change from photographs. A total of 15 dermatologists were engaged in blinded evaluation of photographs. RESULTS: The highest correlation coefficients between delta HECSI scores and delta panel scores of photographs in the first and second evaluation rounds were found for moderate improvement and moderate worsening, rs = -0.46 (P = 0.009) and 0.52 (P = 0.003), respectively, and major worsening, r = 0.41 (P = 0.021). With respect to minor changes, no statistically significant correlations were found (P > 0.05). CONCLUSIONS: In patients with mild HE, photographic assessment was found useful for major and moderate changes only. Further studies would need to be performed in patients with moderate or severe HE, to evaluate whether clinical photographs are able to capture similar changes as HECSI scores.

Comparison of four methods for assessment of severity of hand eczema.

BACKGROUND: Several instruments for the assessment of the severity of hand eczema and health-related quality of life (HR-QoL) related to hand eczema have been developed. OBJECTIVES: The aim of the present study was to evaluate the correlation between frequently used methods. METHODS: Consecutive patients with current hand eczema from three different centres participated in the study. Severity of hand eczema was assessed with the Hand Eczema Severity Index (HECSI), the Physician Global Assessment (PGA), the Clinical Photo Guide, and the Dermatology Life Quality Index (DLQI). RESULTS: One hundred and nineteen patients with hand eczema were included in the study. All six pairwise correlation coefficients between the tested methods were highly statistically significant. Correlation was highest between the HECSI and the PGA (r = 0.82), and weakest, although still statistically significant, between the DLQI and the other three severity scores (r between 0.30 and 0.45). Age and frequency of eruptions did not influence the correlations. With respect to sex, there was a tendency for correlation between methods to be higher for men than for women. CONCLUSION: We found an overall positive correlation between the four severity assessments applied. As the weakest correlation was found between the DLQI and the other methods, it is suggested that measurement of HR-QoL should be included for assessment of the severity and consequences of hand eczema, but the finding also indicates that a disease-specific tool for evaluation of HR-QoL in hand eczema patients is needed.

International guidelines for the in vivo assessment of skin properties in non-clinical settings: Part 2. transepidermal water loss and skin hydration.

BACKGROUND: There is an emerging perspective that it is not sufficient to just assess skin exposure to physical and chemical stressors in workplaces, but that it is also important to assess the condition, i.e. skin barrier function of the exposed skin at the time of exposure. The workplace environment, representing a non-clinical environment, can be highly variable and difficult to control, thereby presenting unique measurement challenges not typically encountered in clinical settings. METHODS: An expert working group convened a workshop as part of the 5th International Conference on Occupational and Environmental Exposure of Skin to Chemicals (OEESC) to develop basic guidelines and best practices (based on existing clinical guidelines, published data, and own experiences) for the in vivo measurement of transepidermal water loss (TEWL) and skin hydration in non-clinical settings with specific reference to the workplace as a worst-case scenario. RESULTS: Key elements of these guidelines are: (i) to minimize or recognize, to the extent feasible, the influences of relevant endogenous-, exogenous-, environmental- and measurement/instrumentation-related factors; (ii) to measure TEWL with a closed-chamber type instrument; (iii) report results as a difference or percent change (rather than absolute values); and (iv) accurately report any notable deviations from this guidelines. CONCLUSION: It is anticipated that these guidelines will promote consistent data reporting, which will facilitate inter-comparison of study results.

International guidelines for the in vivo assessment of skin properties in non-clinical settings: part 1. pH.

BACKGROUND: Skin surface pH is known to influence the dissolution and partitioning of chemicals and may influence exposures that lead to skin diseases. Non-clinical environments (e.g., workplaces) are highly variable, thereby presenting unique measurement challenges that are not typically encountered in clinical settings. Hence, guidelines are needed for consistent measurement of skin surface pH in environments that are difficult to control. METHODS: An expert workshop was convened at the 5th International Conference on Occupational and Environmental Exposure of Skin to Chemicals to review available data on factors that could influence the determination of skin surface pH in non-clinical settings with emphasis on the workplace as a worst case scenario. RESULTS: The key elements of the guidelines are: (i) minimize, to the extent feasible, the influences of relevant endogenous (anatomical position, skin health, time of day), exogenous (hand washing, barrier creams, soaps and detergents, occlusion), environmental (seasonality), and measurement (atmospheric conditions) factors; (ii) report pH measurements results as a difference or percent change (not absolute values) using a measure of central tendency and variability; and (iii) report notable deviations from these guidelines and other relevant factors that may influence measurements. CONCLUSION: Guidelines on the measurement and reporting of skin surface pH in non-clinical settings should promote consistency in data reporting, facilitate inter-comparison of study results, and aid in understanding and preventing occupational skin diseases.

Canadian hand dermatitis management guidelines.

BACKGROUND: Hand dermatitis (HD) is one of the most common skin conditions; however, it is not a homogeneous disease entity. The severity of HD may range from very mild cases to severe chronic forms, which may result in prolonged disability and, occasionally, refractory HD. Chronic hand dermatitis (CHD) is associated with a high health- economic burden and significant loss of quality of life. OBJECTIVE: Although numerous treatment options are available, the management of CHD is often difficult and unsatisfactory. There is a paucity of well-designed, randomized, controlled clinical trials in support of the efficacy of established treatment modalities. CONCLUSION: These guidelines cover the epidemiology, burden, quality of life, etiology, diagnosis, classification, and prevention of HD and provide guidance on management using an approach that is as evidence based as possible.

Management of chronic hand eczema.

Hand eczema (HE) is one of the most frequent skin diseases and has often a chronically relapsing course with a poor prognosis resulting in a high social and economic impact for the individual and the society. In this article, we highlight the results of an expert workshop on the 'management of severe chronic hand eczema' with the focus on the epidemiology, the burden of severe HE, its classification and diagnostic procedures, and the current status of treatment options according to an evidence-based approach (randomized controlled clinical trials, RCTs). We conclude that despite the abundance of topical and systemic treatment options, disease management in patients with severe chronic HE is frequently inadequate. There is a strong need for RCTs of existing and new treatment options based on clearly diagnosed subtypes of HE and its severity.

Compliance in contact allergy with focus on cosmetic labelling: a qualitative research project.

Elimination of the allergen is an effective remedy in allergic contact dermatitis. When contact allergy to a preservative is diagnosed, the patient is instructed to read the labelling of contents and to avoid the use of products containing the allergens. The present study, using qualitative research methods, was performed to examine how socially different groups of patients handle everyday life with allergic contact dermatitis caused by preservatives in consumer products. 8 women were interviewed about reading the ingredient labelling on cosmetic products. Observational studies were carried out as well. The study illustrates that the patients experienced problems when trying to read the labelling of contents. The problems were related to social status and ranged from not being able to read the chemical names of the preservatives to doubting the accuracy of the ingredient labelling. The study indicates that non-compliance with instructions on reading the ingredient labelling is not only a question of patients' lack of knowledge, but also the result of patients not possessing the resources necessary to act in accordance with the medical instructions. The present study is, to our knowledge, the first to apply qualitative research methods to contact dermatitis. The study points out interesting observations about social status and resources in relation to compliance. Further research on this area is necessary to expose the extent of the problem.