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Objectives: Two bolt-on dimensions (skin irritation, self-confidence) have been developed for the EQ-5D-5L to improve its content validity and responsiveness in psoriasis. However, the two bolt-ons are not strictly psoriasis-specific and are potentially relevant in other skin conditions. This study aims to explore the content validity of the EQ-5D-5L with two bolt-ons in patients with atopic dermatitis (AD). Methods: In 2021–2022, qualitative, semi-structured interviews were conducted with 20 adult AD patients at a university dermatology clinic in Hungary. We aimed for a heterogeneous sample in terms of age, gender, education and disease severity. Patients completed the EQ-5D-5L with two bolt-ons using a think-aloud protocol. Probing questions were posed to investigate item relevance, potential conceptual overlaps, missing concepts and the appropriateness of the recall period. Interview transcripts were subjected to thematic analysis. Results: The EQ-5D-5L with the two bolt-ons covered the most important aspects of health-related quality of life in AD patients. Most patients found both the skin irritation and self-confidence bolt-ons relevant. Fifteen potential missing concepts were identified, but only two (social relationships, judgement by others) were identified by more than one patient. A smaller conceptual overlap was found between the skin irritation and pain/discomfort dimensions in 7 patients (35%). Half the patients expressed a preference for a recall period of 1 week rather than of 'today'. Conclusions: The EQ-5D-5L with skin irritation and self-confidence bolt-ons showed good relevance, comprehensiveness and comprehensibility in patients with AD. However, in terms of comprehensiveness, social relationships and judgement by others (stigma) may be missing from the questionnaire. [ABSTRACT FROM AUTHOR]

Purpose: Establishing a meaningful within-individual change (MWIC) threshold is a key aspect for interpreting scores used as endpoints for evaluating treatment benefit. A new patient-reported outcome (PRO), a sleep disturbance numerical rating scale (SD NRS), was developed in adults and adolescents with moderate-to-severe atopic dermatitis (AD). This research aims to establish a MWIC threshold of the SD NRS score in the context of a drug development program. Methods: An explanatory sequential mixed-methods design was used to address the research objective. This mixed-methods design used phase IIb data and a stand-alone qualitative study. Quantitative anchor-based and distribution-based approaches supported by qualitative-based approaches were conducted, and results were triangulated to determine preliminary MWIC thresholds of the SD NRS score. Results: Triangulation of results from both quantitative and qualitative approaches suggested that a 2- to 6-point decrease in the SD NRS score change constitutes a preliminary range of MWIC threshold estimates. Conclusion: This research determined MWIC threshold estimates for the SD NRS score in both adolescents and adults with moderate-to-severe AD using an explanatory sequential mixed-methods design. This mixed-methods design provides interesting insights for establishing MWIC thresholds of a PRO score in the context of a drug development program. [ABSTRACT FROM AUTHOR]

Purpose: "Not relevant" responses (NRRs) on the Dermatology Life Quality Index (DLQI) are common among adults with psoriasis and may be associated with underestimation of disease burden. Little is known about "not relevant" responses among adults with atopic dermatitis. We aimed to examine the frequency of NRRs on the DLQI and to determine whether NRRs are associated with underestimation of disease burden among adults with atopic dermatitis. Methods: Adults with atopic dermatitis were identified and evaluated via online survey. We evaluated the frequency of NRRs on the DLQI, stratified by sociodemographic characteristics. To examine the association between NRRs and other measures of disease burden, Patient-Oriented Eczema Measure (POEM), Patient-Oriented SCORAD (PO-SCORAD), and Short-Form (SF)-12 scores were compared between those who responded "not relevant" versus "not at all". Results: Among 764 adults with atopic dermatitis, most had mild disease. The median (interquartile range [IQR]) POEM, PO-SCORAD, and DLQI scores were 5 (2–10), 24 (14–34), and 2 (1–6), respectively. Most (55.2%) also had at least one NRR, and 17.9% had 4 or more "not relevant" responses, with differences across several sociodemographic characteristics. There were no substantial differences in SF-12, POEM, and PO-SCORAD scores between those who responded "not relevant" versus "not at all". Conclusion: NRRs on the DLQI are common among adults with atopic dermatitis and differ across sociodemographic characteristics, suggesting issues with content validity. There is not a clear association between NRRs and other measures of disease severity among adults with mostly mild atopic dermatitis. [ABSTRACT FROM AUTHOR]

Purpose: To develop a mapping algorithm for generating EQ-5D-5-level (EQ-5D-5L) utility scores from the Dermatology Life Quality Index (DLQI) in patients with atopic dermatitis (AD). Methods: The algorithm was developed using data from 1232 patients from four countries participating in the National Health and Wellness Study. Spearman's rank correlation coefficient was used to evaluate the conceptual overlap between DLQI and EQ-5D-5L. Six mapping models (ordinary least squares [OLS], Tobit, three different two-part models, and a regression mixture model) were tested with different specifications to determine model performance and were ranked based on the sum of mean absolute error (MAE), and root mean squared error (RMSE). Results: The mean DLQI score was 7.23; mean EQ-5D-5L score was 0.78; and there were moderate negative correlations between DLQI and EQ-5D-5L scores (p = − 0.514). A regression mixture model with total DLQI, and age and sex as independent variables performed best for mapping DLQI to EQ-5D-5L (RMSE = 0.113; MAE = 0.079). Conclusion: This was the first study to map DLQI to EQ-5D-5L exclusively in patients with AD. The regression mixture model with total DLQI, and age and sex as independent variables was the best performing model and accurately predicted EQ-5D-5L. The results of this mapping can be used to translate DLQI data from clinical studies to health state utility values in economic evaluations. [ABSTRACT FROM AUTHOR]

Purpose: Management of atopic dermatitis (AD) typically requires application of topical treatments, often multiple times a day. The cosmetic properties and burdensome application of these treatments can be detrimental to quality of life (QoL). Patients who achieve good disease control through use of systemic therapies may reduce the frequency and amount of topical applications, improving QoL. This study aimed to quantify the utility and disutility for topical AD treatment processes.Methods: Seven vignettes describing different skincare regimens for people with moderate-to-severe AD were developed with input from healthcare professionals. 484 respondents from the general population completed time trade-off items for each vignette. Utility values for each regimen, and disutilities associated with the impact of changes to skincare regimens, were calculated. Analysis of variance assessed differences between skincare regimens.Results: As skincare regimens increased in intensity (0.7968 for the most intense; 0.9999 for the least), utility values decreased. There were no statistically significant differences between skincare regimens followed by patients with good disease control (0.9862 to 0.9999); however, when compared to those involving topical corticosteroids and emollient combinations (0.7968 to 0.8835), significant differences were observed (p < 0.001). The largest disutilities (0.1521 to 0.1705) were between skincare regimens describing the use of topical corticosteroids plus emollient and those followed by patients with good disease control.Conclusions: The application of topical treatments has a detrimental effect on QoL, which increases with the duration and frequency of applications. Further research is needed to investigate how health and process utilities interact and both can be integrated into medical decision-making. [ABSTRACT FROM AUTHOR]

Background: Disease-specific patient-reported outcome (PRO) measures are designed to be highly relevant to one disease. It is widely believed that comparisons of outcomes between patients with different diseases are only possible using generic measures. The present study employs a novel method of using Rasch analysis to co-calibrate scores from different disease-specific PRO measures, allowing scores to be compared across diseases. Methods: Psoriasis patients ( n = 146, mean age = 44.4, males = 50 %) completed the Psoriasis Quality of Life scale (PSORIQoL) and atopic dermatitis patients ( n = 146, mean age = 45.5, males = 50 %) the Quality of Life in Atopic Dermatitis scale (QoLIAD). Both measures employ the needs-based model of QoL, and they share five common items-providing a link between assessments. The groups were analysed separately, and then combined to test fit to the Rasch model. Results: Both scales showed good fit to the Rasch model after minor adjustments (PSORIQoL: χ p = 0.25; QoLIAD: χ p = 0.51). For the combined dataset, one common item showing differential item functioning by disease was removed and fit to the Rasch model was achieved ( χ p = 0.08). The co-calibrated scale successfully distinguished between perceived severity groups ( p < 0.001). Conclusions: It is possible to co-calibrate scores on the PSORIQoL and QoLIAD. This is one of the first studies in health research to demonstrate how Rasch analysis can be used to make comparisons across diseases using different disease-specific measures. Such an approach maintains the greater relevance and, consequently, accuracy associated with disease-specific measurement. [ABSTRACT FROM AUTHOR]

Purpose: To determine the prevalence and severity of psychological comorbidity in patients with chronic tinnitus in comparison with other chronic illnesses, namely chronic pain, chronic asthma and atopic dermatitis. Methods: Psychological diagnoses were done according to ICD-10 Chapter V(F). Subjective impairment was evaluated using 5 psychometric questionnaires: tinnitus questionnaire, Berlin mood questionnaire, sense of coherence (SOC-L9) and perceived stress questionnaire. Sleep disturbance was measured by the subdomain 'exhaustion' of the Giessen physical complaints inventory. Results: Somatoform or affective disorders were most frequent in all disease groups. Patients with chronic tinnitus had a stronger SOC and better subjective mood, stronger commitment, and less anger and anxious depression than the patients with chronic pain, chronic asthma or atopic dermatitis. However, in patients with higher tinnitus annoyance, psychological comorbidity was similar to that found in patients with other chronic diseases. Conclusions: Besides collecting medical and social history, special psychometric instruments should be used for the diagnosis of tinnitus patients. Based on relative high frequency of psychological comorbidity, we recommend interdisciplinary cooperation between otorhinolaryngologists and other specialists (psychosomatic medicine, psychology or psychiatry) during the treatment of tinnitus patients, especially when high degree of tinnitus annoyance is involved. [ABSTRACT FROM AUTHOR]

Background: Quality of life (QOL) and clinical severity scores are important parameters in the evaluation of distress experienced by children with atopic dermatitis (AD). The SCORing Atopic Dermatitis (SCOARD) is a widely used clinical score for assessing AD symptomatology over the preceding 3 days and the Nottingham Eczema Severity Score (NESS) is another score useful for AD symptoms over the preceding 12 months.Objective: We evaluated if these parameters are correlated with QOL in children with AD.Patients/methods: We assessed quality of life, clinical scores, total IgE and eosinophil count in peripheral blood in AD patients at our paediatric dermatology clinic over a 14-month period.Results: Eighty AD patients (42 males and 38 females; mean [SD] age 11.7 [3.7] years) were recruited. The median (interquartile range, IQR) IgE, eosinophil counts and eosinophil percentage were 2988 (1069-7847) kIU/L; 0.6 (0.4-0.9) x 10(-9)/L; and 9 (6-12)%, respectively. Quality of life as measured with CDLQI (The Children's Dermatology Life Quality Index) generally did not correlate well with both the acute and chronic AD severity scores (objective SCORAD and total CDQLI, rho = 0.17, p > 0.05; total NESS and total CDQLI, rho = 0.29, p < 0.05). Factor analysis further confirmed that the objective indicators (serum total IgE, eosinophil count and objective SCORAD), self-reported scores (NESS and subjective SCORAD) and CDLQI were separate dimensions in the assessment of AD in children.Conclusion: Quality of life, disease severity scores and laboratory atopic markers represent different domains in AD assessment. They do not necessarily correlate well with each other and all three aspects must be individually evaluated to assess the well-being of these patients. [ABSTRACT FROM AUTHOR]

The PIQoL-AD has been used in several trials assessing quality of life (QoL) in parents of children with atopic dermatitis (AD), treated with pimecrolimus cream 1%. Secondary analysis of data from four trials (n = 621) was undertaken to help interpret the meaningfulness (significance) of the QoL results. A combination of anchor-based and distribution-based methods of interpreting instrument scores were employed. For each level on four AD severity indicators, mean PIQoL-AD scores and 95% confidence intervals were calculated. Low levels of association (r(s) range = 0.12-0.45) were observed between QoL and clinical indicators; confirming previous findings. When data from the different trials and time-points were combined clear patterns emerged indicating the clinical meaning of PIQoL-AD scores. Distribution-based statistics such as effect sizes, the standard error of measurement (SEM) and the standard error of difference (S(diff)) were also calculated. Despite a lack of consensus on how best to determine the meaningfulness of QoL scores, a large database of trial data was successfully used to link QoL scores to disease severity, aiding clinical interpretation of the former. Effect size, SEM and S(diff) values were consistent across the trials indicating that a change of 2 to 3 PIQoL-AD points over time could be considered meaningful. It is argued that it would be useful for clinicians to gain an understanding of the meaning of QoL scores through routine use of such measures in clinical practice. [ABSTRACT FROM AUTHOR]

Health-related quality of life (HRQOL) assessment in children and adolescents with chronic health conditions is increasingly considered as a relevant topic. The aim of the EU-funded DISABKIDS project is to develop, test, and implement European instruments for the assessment of HRQOL of children and adolescents with disabilities and their families. The current paper describes the development and pilot testing of a chronic generic HRQOL measure. Using literature searches, expert consulting and focus groups with children/adolescents and their families, items of the instruments were developed and translated into the respective languages. A pilot test with 360 children and adolescents was conducted. Children and adolescents (8-12, 13-16 years) with different chronic health conditions (asthma, epilepsy, diabetes, arthritis, atopic dermatitis, cerebral palsy, and cystic fibrosis) as well as their families were included. Data were analysed according to predefined psychometric and content criteria. Psychometric analyses resulted in a 56-item chronic generic HRQOL questionnaire with six domains ('Medication', 'Physical', 'Emotion', 'Independence', 'Social Inclusion', 'Social Exclusion') with acceptable internal consistency. [ABSTRACT FROM AUTHOR]

Objective: The international development of the Parents' Index of Quality of Life in Atopic Dermatitis (PIQoL-AD), a quality of life (QoL) instrument specific to parents of children with atopic dermatitis (AD) is described.Method: The instrument was developed simultaneously in several countries. Its content was derived from 65 qualitative interviews with parents in the UK, Netherlands and Italy. The measure was then produced for the UK, Netherlands, Italy, Germany, France, US and Spain. Field-test interviews were conducted with approximately 20 patients in each country to assess face and content validity. A two time-point survey was conducted with between 45 and 328 parents in each country to finalise the instrument through application of the Rasch model and to evaluate the psychometric properties of the final instrument.Results: Application of the Rasch model to the survey data identified the final 28-item version. All language versions had good item fit, test-retest reliability (above 0.85), internal consistency and promising validity.Conclusions: The PIQoL-AD is a valuable instrument for inclusion in clinical trials and routine clinical practice. It provides distinct and complementary information to that of existing dermatology-specific measures and has been shown to be responsive to changes in QoL in clinical trials. [ABSTRACT FROM AUTHOR]

The aim of the study was to evaluate the psychometric properties of the German translation of the Child Health Questionnaire (CHQ). Parents of two clinical samples were asked to rate the quality of life of their children using the German version of the CHQ. Item internal consistency (item-scale correlation) and internal consistency of scales were tested; quartiles and factor analysis were conducted. The results of the German clinical samples were compared with US clinical samples (t-test). The two clinical German sub-groups were compared using multivariate analysis (MANOVA). The psychometric testing of the CHQ showed good results. Internal consistency of the hypothesized scales were all higher than 0.70. The results of the factor analysis confirmed the results of the US norm sample: As expected, the subscales loaded on two factors explaining 57.4% of the total variance. The group comparison supported the discriminative properties of the CHQ. Preliminary psychometric findings support use of the German version of the CHQ. The next step will be the testing of healthy German samples and development of norm scores. [ABSTRACT FROM AUTHOR]