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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. [ABSTRACT FROM AUTHOR]

Background: Low‐flow malformations (LFMs) are rare diseases with a significant impact on health‐related quality of life (HRQoL), especially in children. No disease‐specific questionnaire is available for children with LFMs. Objective: To develop and validate a specific HRQoL questionnaire for children from 11 to 15 years old suffering from LFMs. Methods: A preliminary questionnaire based on a verbatim from focus groups was created and sent to children from 11 to 15 years old suffering from LFMs, together with a dermatology‐specific and a generic HRQoL questionnaire (cDLQI and EQ‐5D‐Y). Results: A total of 75 from 201 included children responded to the questionnaires. The final version of the questionnaire (cLFM‐QoL) included 15 questions and was not divisible into subscales. It demonstrated excellent internal consistency (cronbach 0.89), convergent validity and readability (SMOG 6.04). cLFM‐QoL mean score (± SD) was 12.9/45 (8.03) for all grades of severity, for mild 8.22/45 (7.5), moderate 14.03/45 (8.35), severe 12.35/45 (6.59) or very severe patients 20.7/45 (3.39) (p 0.006). Conclusion: cLFM‐QoL is a validated short and easy to use specific questionnaire with excellent psychometric capacities. It will be suitable for any children aged 11–15 with LFMs, in daily practice or clinical trials. [ABSTRACT FROM AUTHOR]

Background: The skin plays an important role in establishing interpersonal relationships, and thus visible skin disorders, which have a significant impact on physical appearance, influence other people's behaviours and attitudes. Objective: To develop and validate a dermatologic‐specific questionnaire to evaluate stigmatization in individuals with visible skin conditions. Methods: Items were generated by a verbatim report based on qualitative interviews with patients with various dermatologic conditions. Subsequently, a study was implemented for psychometric analysis. A dermatology‐specific stigmatization questionnaire (PUSH‐D) was refined via item reduction according to inter‐question correlations, consensus among experts and exploratory factor analysis. Internal consistency was determined by calculating Cronbach's α. Concurrent validity was determined by calculating the correlation between PUSH‐D and the Dermatology Life Quality Index (DLQI) and the Rosenberg Self‐Esteem Scale (RSES). Results: From a primary list of 22 items, PUSH‐D was reduced to a 17‐item questionnaire, covering two pertinent dimensions based on the exploratory factor analysis. Construct validity was demonstrated, and PUSH‐D showed good internal consistency (Cronbach's α = 0.9). PUSH‐D correlated strongly with the DLQI 0.72 (p < 0.001) and moderately with the RSES 0.49 (p < 0.001). Conclusion: PUSH‐D allows a comprehensive view of the degree of stigmatization in visible skin disorders, as well as the comparability of stigmatization levels across various skin conditions. [ABSTRACT FROM AUTHOR]

Background: The assessment of the individual evolution of vitiligo is important for therapeutic decision making in daily practice. A fast, simple and validated physician‐reported score to assess clinical changes in depigmentation over time in separate parts (activity and improvement) is currently missing. Objective: The main objective of the study was to develop and validate the Vitiligo Disease Activity Score (VDAS) and Vitiligo Disease Improvement Score (VDIS). Methods: The Vitiligo Disease Activity Score (VDAS) and Vitiligo Disease Improvement Score (VDIS) were evaluated based on a photo set of 66 patients with two different time points. In the first (short) version, only the number of changing body regions was counted based on 15 predefined areas (VDAS15 and VDIS15), while in the second (extensive) version the degree of worsening or improvement from +4 to −4 for each body area was added for a more detailed assessment (VDAS60 and VDIS60). Content and construct validity were tested. In addition inter‐, intrarater reliability and feasibility were evaluated by 7 (test) and 5 (retest) physicians. Results: Evidence for content and construct validity was provided. Overall, VDAS15, VDIS15, VDAS60 and VDIS60 demonstrated good to excellent inter‐rater reliability [intraclass correlation (ICC): VDAS: range = 0.797–0.900; VDIS: range = 0.726–0.798]. The intrarater reliability ICCs were 0.865 and 0.781 for the VDAS15 and VDIS15, respectively. Similar results were obtained for the VDAS60 and VDIS60 (ICC = 0.913 and 0.800, respectively). Completion time was short (median: 122 s/patient (first round); 95 s/patient (second round)]. Limitations: Single tertiary centre mainly of skin phototype 2 to 3. Conclusion: The VDAS and VDIS appear to be valid, reliable and feasible instruments to score the evolution of vitiligo lesions. This accommodates the current urgent need for a simple, standardized and practical assessment of vitiligo activity and improvement over time. [ABSTRACT FROM AUTHOR]

Background: Vitiligo management is challenging and requires long‐term adherence of patients who often complain of the burden associated with treatment. Objective: To develop and validate a patient reported measurement of the burden of treatment in vitiligo. Methods: The study was nested within the ComPaRe Vitiligo e‐cohort, an online e‐cohort of vitiligo patients in France. Items were derived from a literature review and from the qualitative analysis of a survey using open‐ended questions of 204 patients with Vitiligo. Construct validity of the resulting instrument was assessed by comparing the instrument's score to the Dermatology Life Quality Index (DLQI), Vitiligo Impact Patient score (VIPs) and Treatment Burden Questionnaire (TBQ) scores. Reliability was assessed by test‐retest with 15 ± 10 days of interval between both assessments. Results: In total, 343 adult participants participated in the validation of the Vitiligo Treatment Impact score (VITs). The VITs is a 19‐item questionnaire assessing the burden of treatment in patients with vitiligo with results suggesting four domains ('Finding a doctor', 'Phototherapy', 'Topical treatment' and 'Impact on outdoor activities and photoprotection'). The VITs total score was well correlated with the DLQI, VIP and TBQ scores. Agreement between test and retest was good (ICC 0.705, 95% CI 0.491–0.818). Conclusions: We developed a patient reported measurement of the burden of treatment in vitiligo with good psychometric properties. [ABSTRACT FROM AUTHOR]

Background: Hidradenitis suppurativa (HS) is a painful chronic, recurrent inflammatory skin disease with great impact on health‐related quality of life (HRQOL). Recently, Hidradenitis SuppuraTiva cORe outcomes set International Collaboration (HISTORIC) established HRQOL as a core domain set for HS clinical trials and developed the Hidradenitis Suppurativa Quality of Life (HiSQOL) as a validated outcome measurement instrument. Objectives: To provide further convergent validity of HiSQOL by comparing it to Dermatology Life Quality Index (DLQI) and Pictorial Representation of Illness and Self Measure‐Revised 2 (PRISM‐R2). Methods: In this cross‐sectional study, 103 participants completed HiSQOL, PRISM‐R2 and DLQI. PRISM‐R2 is an instrument designed to measure suffering and reports the two measures, Illness Perception Measure (IPM) and Self‐Illness Separation (SIS). Correlation analyses were performed including a sub‐analysis for a subgroup of patients with high scores in the HS‐specific domains of HiSQOL. Results: A very strong correlation was found between HiSQOL and DLQI (ρ = 0.93, P < 2.2 × 10−16, (95% CI: 0.89;0.95)), and moderately strong correlations were found between HiSQOL and SIS (ρ = −0.73, P < 2.2 × 10−16, (95% CI: −0.81; −0.62)) and DLQI and SIS (ρ = −0.70, P < 2.2 × 10−16, (95% CI: −0.79; −0.59)). IPM was positively associated with HiSQOL and DLQI and negatively with SIS. Conclusions: HiSQOL is a valid measure of quality of life for HS patients, and we suggest that HiSQOL can be used as a measure of suffering as well. Linked commentary: C.C. Zoubouli et al. J Eur Acad Dermatol Venereol 2021; 35: 1420–1421. https://doi.org/10.1111/jdv.17306. [ABSTRACT FROM AUTHOR]

Background: The Harmonising Outcome Measures for Eczema (HOME) initiative has agreed that quality of life should be measured in all atopic eczema clinical trials. Various candidate instruments exist for this domain but their content validity in atopic eczema is largely unclear. Objective: To assess the content validity of quality‐of‐life candidate instruments for atopic eczema in infants, children and adults in order to aid the decision on what instrument to include in the core outcome set for the quality‐of‐life domain. Methods: Six group discussions were conducted at the HOME VII Meeting in Tokyo. Each group was composed of 8–12 patients or parents of patients, clinicians, methodologists and pharmaceutical industry delegates and discussed one or two candidate instruments. The COSMIN criteria on relevance, comprehensiveness and comprehensibility were used to determine the overall content validity rating per instrument. Results: Content validity of the Infant's Dermatitis Quality of Life Index, Children's Dermatology Life Quality Index and the Childhood Atopic Dermatitis Impact Scale (CADIS) long‐form was rated as sufficient (+). Results for the CADIS short‐form, DLQI and Skindex were inconsistent (±). DISABKIDS, Infants and Toddlers Dermatology Quality of Life and ABS‐A were classified as having insufficient content validity. Conclusions: The content validity rating allowed for a comparison of all candidate instruments and informed the consensus‐seeking process regarding the core instrument for the quality‐of‐life domain. [ABSTRACT FROM AUTHOR]

Background: Multiple clinician‐reported outcome measures exist for atopic dermatitis (AD) severity. However, there is no gold standard for use in clinical practice. Objectives: To determine the measurement properties of the product of validated Investigator's Global Assessment for AD (vIGA) and body surface area (BSA) overall or divided into six categories (cBSA: 0%/0.1, <10%/10, <30%/30, <50%/50, <70%/70 and <90%/90–100%) and compare with other clinician‐reported and patient‐reported outcomes in adults and children with AD. Methods: We performed a prospective dermatology practice‐based study using questionnaires and evaluation by a dermatologist (n = 653). Results: vIGA*BSA and vIGA*cBSA had good convergent validity with BSA (Spearman's ρ = 0.97 and 0.93), eczema area and severity index (ρ = 0.94 and 0.92), and objective SCORAD (ρ = 0.88 and 0.89); and weak‐to‐good convergent validity with Numeric Rating Scale average itch (ρ = 0.22 and 0.22) and worst itch (ρ = 0.27 and 0.28), Patient‐Oriented Eczema Measure (ρ = 0.44 and 0.43), Dermatology Life Quality Index (ρ = 0.48 and 0.49), ItchyQOL (ρ = 0.45 and 0.46), PROMIS Sleep Disturbance (ρ = 0.46 and 0.37) and sleep‐related impairment (ρ = 0.31 and 0.31) in adults and/or children; very good discriminant validity for physician‐reported global AD severity; good responsiveness to change of severity of AD and itch; and good reliability (intraclass correlation coefficient [95% confidence interval]: 0.72 [0.60–0.81] and 0.74 [0.62–0.82]) with no floor or ceiling effects. Thresholds for interpretability bands and clinically important difference were established. Conclusions: vIGA*BSA and vIGA*cBSA scores showed good convergent and discriminant validity, reliability, responsiveness and interpretability in adults and children with AD, and were feasible for use in clinical practice. vIGA*BSA and vIGA*cBSA had slightly lower convergent validity than EASI or objective SCORAD, but might be more efficient to collect and score. [ABSTRACT FROM AUTHOR]

Background: The Self Assessment Vitiligo Extent Score (SA‐VES) is a validated, patient‐reported outcome measure to assess the body surface area affected with vitiligo. Information on how to translate the obtained score into extent, severity and impact strata (mild–moderate–severe) is still lacking. Stratification is helpful to define inclusion criteria for trials, enables comparison and pooling of trial results and can be used for epidemiological research. Objectives: The aim was to develop extent, severity and impact strata for the SA‐VES based on validated anchor‐based questions. Methods: In total, 315 patients with vitiligo (non‐segmental; age ≥ 16) recruited at the Ghent University Hospital (Belgium) completed a questionnaire that was conducted in cooperation with the Dutch Society for vitiligo patients to ensure content validity. First three anchor questions included in the questionnaire [Patient Global Assessment (PtGA) for vitiligo extent, severity and impact] were assessed for content validity, construct validity and intrarater reliability. Subsequently, the PtGAs were used to stratify the SA‐VES based on ROC analysis. Results: For all PtGAs (PtGA extent, PtGA severity, PtGA impact), at least 75% of hypotheses evaluated for construct validity were confirmed. Intrarater reliability of all PtGAs was good to excellent (ICCs PtGA extent: 0.623; PtGA severity: 0.828; PtGA impact: 0.851). The optimal cut‐off values of the SA‐VES between the three global categories (mild/limited – moderate – severe/extensive) were 1.05% and 6.45% based on PtGA extent, 2.07% and 4.8% based on PtGA severity and 2% and 3.35% based on PtGA impact. Conclusion: This study provides the first guide for the interpretation of the numerical output obtained by the SA‐VES (vitiligo extent) and enables the translation into a global vitiligo grading for extent, severity and impact. As patients' interpretation of vitiligo extent, severity and impact may vary amongst patients worldwide, future international studies will be required. [ABSTRACT FROM AUTHOR]

Background: The Childhood Atopic Dermatitis Impact Scale (CADIS) with 45 items may be burdensome to complete. We therefore aimed to develop a CADIS short‐form. Methods: Parents of 300 children completed the prototype CADIS. Exploratory factor analysis was conducted on the 45‐item CADIS version. The most representative items were chosen. Confirmatory factor analysis was used to confirm the a priori factor structure. Content validity was assessed in a focus group of patients, parents, clinicians, methodologists and industry delegates. Internal consistency, 48‐h test–retest reliability, construct validity and responsiveness of the newly developed short‐form were assessed. Results: A total of 270 families provided data at baseline, 34 after 48 h and 228 after 4 weeks. Fourteen items of three different factors fulfilled the proposed eligibility criteria and were included in the draft short‐form. After the content validity rating, one item relating to the child's sleep was added to further improve content validity. The confirmatory factor analyses showed good model fit, and a 15‐item short‐form was initiated, the CADIS‐SF15. The total scale and the three domains showed good internal consistency and test–retest reliability. The correlation between SCORAD and other subjective measures was consistent with our hypotheses. Differences in scores between mild, moderate and severe AD patients were significant, and the CADIS‐SF15 was able to detect changes in 'improving' patients over time. Conclusion: The CADIS‐SF15 with 15 items in three domains is an internally consistent, reliable, valid, responsive and brief measure of QoL in children affected with AD and their parents. Further evaluation of clinical applicability is required. [ABSTRACT FROM AUTHOR]

Background: Patients with psoriasis are at risk of a co‐morbid diagnosis of depression and/or anxiety. It is therefore essential for dermatologists to have valid and effective instruments that can screen and monitor depression and anxiety symptoms in psoriasis patients. Objective: The aim of this study was to validate the Mental Health Inventory (MHI‐5) as a brief measure that can be used to evaluate psychological distress related to anxiety and depression in psoriasis patients. Methods: The sample included 76 adult dermatological outpatients diagnosed with psoriasis. Participants completed the MHI‐5, the Hospital Anxiety and Depression Scale (HADS) and six subscales of the Self‐Compassion Scale (SCS). Confirmatory factor analysis (CFA) was applied to examine the factor structure of MHI‐5. Convergent validity was examined by applying correlations among all measures. Discriminant validity was examined by applying hierarchical regression models. Reliability was examined by calculating Cronbach's alpha coefficient. Results: Confirmatory factor analysis showed that the proposed one‐factor model has a good fit to the data. The MHI‐5 demonstrated satisfactory convergent validity by yielding significant moderate to strong correlations with the HADS and with the positive and negative subscales of the SCS. Discriminant validity was also evident with being at risk of anxiety predicting MHI‐5 scores above and beyond the effect of gender and age. Hierarchical regressions were not performed because a very small number of participants (n = 3) were classified at risk of depression. The MHI‐5 showed high internal consistency (α = 0.84). Conclusion: This investigation provided evidence that MHI‐5 is a reliable and valid instrument that can be used to effectively capture psychological distress in psoriasis patients. [ABSTRACT FROM AUTHOR]

Selection process of measures for core outcome set should utilize the highest methodology level and should be maximally free of bias. Comment on 'IDQoL, CDLQI and the 45-item CADIS received a sufficient content validity rating during the HOME VII meeting in Japan: a group discussion study' We are happy that content validity of the most widely used and comprehensive atopic dermatitis (AD) specific proxy quality of life (QoL) questionnaire the IDQoL and dermatology-specific questionnaire the CDLQI was positively assessed by meeting's participants. [Extracted from the article]

Background A wide variety of scoring systems have been proposed to assess severity of psoriasis. Given its importance as a health issue both for patients and health care systems, it is critically important to evaluate the validity and reliability of existing outcome measures. Objective The objective of this systematic review was to assess the extent of validation including the validity, reliability, sensitivity to change and ease of use of available outcome measures for psoriasis. Materials and Methods We conducted a systematic review of all clinical studies (prospective and retrospective) investigating the severity of psoriasis patients and published between January 1980 and June 2009. The following methodological validation and quality criteria were recorded systematically: construct validity, content validity and internal consistency, intra-observer variation and inter-observer variation, sensitivity to change and acceptability/ease of use assessed as time required to perform measurement. Results Based on methodological validation and quality criteria, six clinical severity scores were selected and analysed (PASI, BSA, PGA, LS-PGA, SPI and SAPASI scores). We did not find substantial evidence of construct validity for any of the psoriasis clinical severity scores. Content validity was studied by considering the PASI score as gold standard. The relative content validity was good for the LS-PGA, PGA, and SPI scores, which correlated strongly with the PASI score. The SAPASI and PASI scores showed moderate correlation. Internal consistency was good for the PASI and LS-PGA scores. The PASI, BSA, PGA and LS-PGA scores displayed limited intra-observer variation. The inter-observer variation was low for LS-PGA (ICC < 0.5) and SAPASI, moderate for PASI, SPI and PGA and high for BSA (ICC > 0.8). The PASI score and the SAPASI displayed moderate sensitivity to change. Discussion Based on this systematic review, it appears that none of the severity scores used for psoriasis meets all of the validation criteria required for an ideal score. However, we can conclude that the PASI score is the most extensively studied psoriasis clinical severity score and the most thoroughly validated according to methodological validation criteria. Despite certain limitations, use of the PASI score can be recommended for scientific evaluation of the clinical severity of psoriasis. [ABSTRACT FROM AUTHOR]