Dermatology Life Quality Index Data Research Articles

421 The role of itch resolution and skin clearance in patient-reported atopic dermatitis severity and quality of life: real-world insights from TARGET-DERM AD

Abstract Severity of atopic dermatitis (AD) itch and lesions is associated with poor quality of life. However, there is limited evidence describing the combined impact of itch and skin severity on patient outcomes in AD. This study aims to assess the independent and combined effects of itch and skin severity on patient-reported symptoms and quality-of-life outcomes. The study included adult participants (age ≥18 years) with AD enrolled in TARGET-DERM AD, an observational, longitudinal study of more than 3158 participants across 43 academic/community centers in the USA and Canada. Itch severity was assessed by the Patient-Reported Outcome Measurement Information System Itch-Severity, specifically the item evaluating ‘itch at its worst’, a 0–10 numeric rating scale. A score of 0 or 1 was interpreted as no/minimal itch. Skin severity was assessed by the validated Investigators Global Assessment of AD (vIGA-AD), with a score of 0 or 1 representing clear/almost clear skin (vIGA-AD 0/1). The association of AD symptoms representing patient-reported clear/almost clear disease [Patient-Oriented Eczema Measure (POEM) 0–2] and no impact of AD on quality of life [Dermatology Life Quality Index (DLQI) 0/1] with itch and skin severity was assessed using descriptive statistics and logistic regression models that included main and interaction effects for itch and skin severity. Among adult participants (n = 1795; 59% female; 60% non-Hispanic White; mean age 44.5 years), vIGA-AD, POEM, Worst Itch and DLQI data at enrollment were available for 95% (1702), 44% (792), 43% (783) and 43% (783) of participants, respectively. The proportion reporting POEM 0–2 and DLQI 0/1 was highest among those with no/minimal worst itch (73% POEM 0–2; 72% DLQI 0/1) and clear/almost clear skin (46% POEM 0–2; 45% DLQI 0/1), with decreasing proportions observed at greater itch and skin severity levels. Among those with both no/minimal itch and clear/almost clear skin, 87.5% (42/48) and 95.8% (46/48) reported POEM 0–2 and DLQI 0/1, respectively. Logistic regression results suggest that no/minimal itch and clear/almost clear skin are significantly associated with POEM 0–2 and DLQI 0/1, though the interaction effect was not statistically significant in despite all models assessed. Relative to those who did not have either no/minimal itch or clear/almost clear skin, the odds ratio of reporting POEM 0–2 and DLQI 0/1 was highest among those with both no/minimal itch and clear/almost clear skin (82.9 for POEM 0–2; 35.4 for DLQI 0/1), followed by no/minimal itch only (15.9 for POEM 0–2; 10.5 for DLQI 0/1) and clear/almost clear skin only (5.9 for POEM 0–2; 3.8 for DLQI 0/1). Complete or almost complete relief of itch and skin lesions is associated with greater odds of achieving ideal states in PROs (POEM and DLQI) with itch relief exhibiting a relatively higher impact than skin clearance. These results underscore the importance of assessing and documenting both itch severity and skin clearance to support shared decision-making. Moreover, clearance of both itch and skin lesions should be considered when setting treatment goals in patients with AD. Future research should include analyzing discrepant data (e.g. patients with no/minimal itch, but some skin lesions) to more precisely identify which aspect drives the patient-reported outcomes.

Psoriasis severity: commonly used clinical thresholds may not adequately convey patient impact.

Psoriasis severity is usually evaluated using quantitative and qualitative measures, including per cent body surface area (BSA) involvement, the Psoriasis Area and Severity Index (PASI) and the Dermatology Life Quality Index (DLQI), a patient-reported questionnaire. However, standardized definitions for psoriasis severity categories have not been well established. A PASI of 10 or 12 has remained the minimal severity threshold defining eligibility for psoriasis treatments. In the present study, the validity of this cut-off was re-evaluated in the context of quality of life. To determine whether the thresholds commonly used to define moderate psoriasis (PASI of 10-12 and BSA of 10) are supported by patient-reported DLQI data. A systematic review of randomized controlled trials that enrolled mild or moderate patients published between January 2000 and June 2017 was used to assess correlations between provider and patient-generated severity at baseline. For subject groups with high impact on quality of life (DLQI>10), the mean weighted BSA was 7.6 (Range: 7.1-8.4) and the mean weighted DLQI was 11 (Range: 10.2-12.2). Similarly, the mean weighted PASI for patients with DLQI>10 was 8.7 (Range: 7.1-10.1) and the mean weighted DLQI was 10.9 (Range: 10.1-12.2). Patients with PASI or BSA scores less than 10 can have major quality of life impairment. In general, the objective measures of BSA and PASI alone, when excluding DLQI, may not fully capture the impact of disease severity.

PSY31 The Relevance of 'not Relevant' Responses on the Dlqi: A Rasch Analysis in Patients with Psoriasis

Dermatology Life Quality Index (DLQI) is the most frequently used quality of life questionnaire in psoriasis patients. In eight out of the 10 items of the DLQI, patients may answer that the item does not apply to their life ('not relevant' response). We aim to compare the measurement performance of DLQI in psoriasis patients with and without 'not relevant' responses using an application of item response theory (Rasch analysis). Cross-sectional data of 425 patients with psoriasis were analysed. Patients were divided into two groups: those with (R-group) and without any 'not relevant' responses (NR-group). A partial credit model was applied to the DLQI data. The following model assumptions and measurement properties were tested: dimensionality, item fit, person reliability, order of response options and differential item functioning (DIF). A total of 259 (60.9%) and 166 (39.1%) patients belonged to the R- and NR-group, respectively. The NR-group tended to be, on average, 10 years older, more likely female, have chronic plaque psoriasis, palmoplantar psoriasis or psoriatic arthritis and associated with higher disease severity scores (p<0.05). Both for the R- and NR-group, the DLQI demonstrated a unidimensional construct and an acceptable reliability. Person separation reliability was slightly better in the R-group (0.920 vs. 0.899). In the NR-group, response thresholds were disordered for items 6 (sport), 7 (working/studying) and 9 (sexual difficulties), whereas in the R-group, only item 7 was illogically ordered. Seven of the 10 items exhibited DIF between the R- and NR-group. The Rasch model suggests that 'not relevant' responses lead to measurement bias in the DLQI. Scores of patients with and without 'not relevant' responses should not be compared. Further efforts are needed to effectively revise the DLQI and to standardise quality of life measurement in patients with psoriasis.

Mapping Dermatology Life Quality Index (DLQI) scores to EQ-5D utility scores using data of patients with atopic dermatitis from the National Health and Wellness Study

PurposeTo 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).MethodsThe 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).ResultsThe 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).ConclusionThis 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.

PSY7 INDIRECT COST BURDEN OF MODERATE-TO-SEVERE PSORIASIS IN EU5 AND THE SAVINGS GENERATED BY CHOOSING GUSELKUMAB OVER ADALIMUMAB

Moderate-to-severe psoriasis (PsO) is associated with a substantial health and economic burden globally; work productivity loss (absenteeism and presenteeism) is a major contributor. This study aims to estimate the PsO-associated indirect cost burden in the EU5 (France, Germany, Italy, Spain and UK) and to demonstrate the indirect cost savings which would result from treatment with guselkumab instead of adalimumab. A costing model to calculate burden and savings was developed. The number of employed moderate-to-severe PsO patients across the EU5 was multiplied by the annual productivity gain resulting from treatment with guselkumab instead of adalimumab. Numbers of employed moderate-to-severe PsO patients were based on 2016 population data and employment rates adjusted by moderate and severe PsO prevalence rates. These data were collected through a targeted literature review including OECD and Eurostat databases. Annual productivity gain was based on average wages combined with previous analyses which established the relationship between improvement in the Dermatology Life Quality Index (DLQI) and increase in work productivity. DLQI data were derived from the VOYAGE 1 & 2 clinical trials at week 48 and productivity loss due to PsO was obtained from Villacorta et al. (2017). It was estimated that 1.8 million patients with moderate-to-severe PsO were employed in the EU5 in 2016. The PsO-associated indirect cost burden was approximately €15 billion per year. Treating eligible employed moderate-to-severe PsO patients with guselkumab instead of adalimumab would lead to indirect cost savings of approximately €165 million per year, equating to €409 indirect cost savings per patient per year. The economic burden associated with reduction in work productivity of patients with moderate-to-severe PsO is high and has a significant impact on society. Treating patients with guselkumab is predicted to lead to increased work productivity and consequently, substantial indirect cost savings.

Reporting of Quality of Life in Clinical Trials of Biologics for Plaque Psoriasis: A Systematic Review

Background: Psoriasis is a chronic remitting and relapsing skin disease. For many patients, improved quality of life (QoL) is as important as clinical improvement of lesions.Objective: To review reporting of Dermatology Life Quality Index (DLQI) in randomized controlled trials (RCTs) of biologics for adult patients with plaque psoriasis.Methods: A systematic review was conducted in 4 databases for RCTs that measured DLQI at baseline and endpoint. A data collection form was created for collecting study variables. Risk of bias was assessed using the Cochrane risk of bias tool.Results: Thirty-four RCTs enrolling 16,784 patients were included. Complete baseline and final mean DLQI data was retrieved for 24 studies (70.6%). The mean DLQI at baseline was reported in 79.4% of RCTs. The median at baseline was reported in 14.7% of RCTs. The mean DLQI at endpoint was reported in 23.5% of RCTs and the median DLQI at endpoint was reported in 5.9% of RCTs. The mean change in DLQI was reported in 64.7% of RCTs.Conclusions: DLQI was measured in most clinical trials assessing the efficacy of biologics for psoriasis. Studies did not adhere to uniform standards in publishing results, making analysis of the impact on DLQI challenging.Key Words: plaque psoriasis, quality of life, Dermatology Life Quality Index, Systematic Review, biologic therapy

Psychometric properties of the Children’s Dermatology Life Quality Index in pediatric localized scleroderma

The Children's Dermatology Life Quality Index has been used to measure quality of life in studies of pediatric localized scleroderma, which suggested only modest effects on quality of life. However, the Children's Dermatology Life Quality Index psychometric performance has not been examined in localized scleroderma and it was validated in populations lacking localized scleroderma's distinctive clinical features, possibly underestimating the quality of life impact. This study assessed psychometric properties of the Children's Dermatology Life Quality Index in a cohort of pediatric localized scleroderma patients. Existing Children's Dermatology Life Quality Index data from a large pediatric localized scleroderma cohort were analyzed. Children's Dermatology Life Quality Index score distributions were examined and internal consistency was evaluated with Cronbach's alpha for the entire Children's Dermatology Life Quality Index and after deletion of individual items. Construct validity was assessed by calculating Spearman's correlations between Children's Dermatology Life Quality Index scores and disease severity/impact measures. Dimensionality was examined using exploratory factor analysis with sequential item elimination. Children's Dermatology Life Quality Index scores suggested modest adverse effects on quality of life. Internal consistency was adequate (Cronbach's alpha = 0.727) but increased after eliminating items regarding friendships, sleep, and treatment burdens. Children's Dermatology Life Quality Index scores were not associated with physician-scored disease severity measures but were moderately associated with patient/parent assessments of disease impact. Exploratory factor analysis yielded a three-factor solution encompassing functional limitations, psychosocial effects, and skin symptoms/treatment burden. The Children's Dermatology Life Quality Index may capture functional and psychosocial domains of quality of life in localized scleroderma, but likely underestimates the quality of life impact given that it includes some items with limited relevance in localized scleroderma, incompletely explores skin symptoms and treatment burdens, and demonstrates limited construct validity. Further study to optimize quality of life measurement in pediatric localized scleroderma is warranted.

Time, Psoriasis Area and Severity Index and Dermatology Life Quality Index of patients with psoriasis who drop out of clinical trials on etanercept because of lack of efficacy: a pooled analysis from 10 clinical trials

Patient-reported outcomes in psoriasis studies are assessed at specific study time points. If a treatment has not become effective by a certain time point, it may increase the likelihood of patients being dissatisfied and leaving a clinical study. To generate evidence concerning the number of patients dropping out of etanercept trials over time including Psoriasis Area and Severity Index (PASI) and Dermatology Life Quality Index (DLQI) data. Data from patients with psoriasis in 10 trials with etanercept were pooled. Analyses were performed for (i) patients who dropped out because of 'lack of efficacy' and (ii) patients who continued the trial. The PASI and DLQI data were summarized for different time points. The distribution of dropout over time, PASI, DLQI and the proportion of patients dropping out with given treatment responses were calculated. Of 6119 patients, 128 dropped out because of lack of efficacy (or synonym). The highest increase of patients dropping out happened between day 75 and 85 (cumulative percentage rise from 46% to 73%). The lowest PASI of patients dropping out was 6·3 within 120 days. Individuals who dropped out who achieved ≥ PASI 75 (at least a 75% improvement from baseline PASI) were rare. A critical time when many patients might have lost their willingness to wait for their treatment with etanercept to show a better effect appeared to be at around day 80. Most of the patients dropping out showed little improvement, stable disease or worsening of their psoriasis.

Generating EQ-5D-3L Utility Scores from the Dermatology Life Quality Index: A Mapping Study in Patients with Psoriasis

Objectives†List of members: Jonathan Barker, MD, FRCP; Marilyn Benham; David Burden, MD, FRCP; Ian Evans; Chris Griffiths, MD, FRCP; Sagair Hussain, PhD; Brian Kirby, MRCP; Linda Lawson; Kathy McElhone, PhD; Ruth Murphy, MB ChB, PhD, FRCP; Anthony Ormerod, MB, MD, FRCP; Caroline Owen, MBChB, FRCP; Nick Reynolds, MD, FRCP; Catherine Smith, MD, FRCP.To develop an algorithm to predict the three-level EuroQol five-dimensional questionnaire (EQ-5D-3L) utility scores from the Dermatology Life Quality Index (DLQI) in psoriasis. MethodsThis mapping study used data from the British Association of Dermatologists Biologic Interventions Register—a pharmacovigilance register comprising patients with moderate to severe psoriasis on systemic therapies. Conceptual overlap between the EQ-5D-3L and DLQI was assessed using Spearman rank correlation coefficients and exploratory factor analysis. Six regression methods to predict the EQ-5D-3L index (direct mapping) and two regression methods to predict EQ-5D-3L domain responses (response mapping) were tested. Random effects models were explored to account for repeated observations from the same individual. Estimated and actual EQ-5D-3L utility scores were compared using 10-fold cross-validation (in-sample) to evaluate predictive performance. Final models were selected using root mean squared error, mean absolute error, and mean error. ResultsThe data set comprised 22,085 observations for which DLQI and EQ-5D-3L were recorded on the same day. A moderate correlation was found between the measures (r = −0.47). Exploratory factor analysis showed that two EQ-5D-3L domains (pain/discomfort and depression/anxiety) were associated with all six DLQI domains. The best-performing model used ordinary least squares with DLQI items, age, and sex as explanatory variables (with squared, cubic, and interaction terms). A tool was produced to allow users to map their data to the EQ-5D-3L, and includes algorithms that require fewer variables (e.g., total DLQI scores). ConclusionsThis study produced mapping algorithms that can generate EQ-5D-3L utility scores from DLQI data for economic evaluations of health interventions for patients with psoriasis.

Mapping of the DLQI scores to EQ-5D utility values using ordinal logistic regression

PurposeThe Dermatology Life Quality Index (DLQI) and the European Quality of Life-5 Dimension (EQ-5D) are separate measures that may be used to gather health-related quality of life (HRQoL) information from patients. The EQ-5D is a generic measure from which health utility estimates can be derived, whereas the DLQI is a specialty-specific measure to assess HRQoL. To reduce the burden of multiple measures being administered and to enable a more disease-specific calculation of health utility estimates, we explored an established mathematical technique known as ordinal logistic regression (OLR) to develop an appropriate model to map DLQI data to EQ-5D-based health utility estimates.MethodsRetrospective data from 4010 patients were randomly divided five times into two groups for the derivation and testing of the mapping model. Split-half cross-validation was utilized resulting in a total of ten ordinal logistic regression models for each of the five EQ-5D dimensions against age, sex, and all ten items of the DLQI. Using Monte Carlo simulation, predicted health utility estimates were derived and compared against those observed. This method was repeated for both OLR and a previously tested mapping methodology based on linear regression.ResultsThe model was shown to be highly predictive and its repeated fitting demonstrated a stable model using OLR as well as linear regression. The mean differences between OLR-predicted health utility estimates and observed health utility estimates ranged from 0.0024 to 0.0239 across the ten modeling exercises, with an average overall difference of 0.0120 (a 1.6% underestimate, not of clinical importance).ConclusionsThis modeling framework developed in this study will enable researchers to calculate EQ-5D health utility estimates from a specialty-specific study population, reducing patient and economic burden.

Screening for anxiety and depression in people with psoriasis: a cross-sectional study in a tertiary referral setting.

National Institute for Health and Care Excellence guidance recommends assessment of psychological and social well-being in people with psoriasis. To screen systematically for depression and anxiety in patients with psoriasis in routine clinical practice and to identify at-risk groups for psychiatric morbidity. Consecutive patients attending a single, tertiary centre over a 10-month period were invited to complete the Patient Health Questionnaire Depression Scale (PHQ-9), Generalized Anxiety Disorder Scale (GAD-7) and Dermatology Life Quality Index (DLQI) as part of IMPARTS: Integrating Mental and Physical Healthcare: Research, Training and Services. Information on demographics, treatment and clinical disease severity was collated from electronic patient records. Regression models were used to identify at-risk groups for psychiatric morbidity. Of 607 patients included (56·2% on biologics), 9·9% (95% confidence interval 7·5-12·3%) screened positive for major depressive disorder (MDD) and 13·1% (79/604) (95% confidence interval 10·4-15·8%) for generalized anxiety disorder (GAD; GAD-7 score > 9). Suicidal ideation was reported in 35% of those with MDD; DLQI was < 10 in 38·3% and 45·6% cases of MDD and GAD, respectively. After adjusting for covariates, the risk of MDD or GAD was significantly higher in women and those with severe clinical disease, psoriatic arthritis and previous depression/anxiety. The risk of GAD was significantly increased with Asian ethnicity and use of topical treatments only. Systematic screening for anxiety and depression identifies clinically important levels of depression and anxiety that may be missed using DLQI data alone. Women and those with severe disease, psoriatic arthritis and/or a prior history of psychiatric morbidity may be at particular risk.

Can We Rely on the Dermatology Life Quality Index as a Measure of the Impact of Psoriasis or Atopic Dermatitis?

The Dermatology Life Quality Index (DLQI) is a widely used health-related quality of life measure. However, little research has been conducted on its dimensionality. The objectives of the current study were to apply Rasch analysis to DLQI data to determine whether the scale is unidimensional, to assess its measurement properties, test the response format, and determine whether the measure exhibits differential item functioning (DIF) by disease (atopic dermatitis versus psoriasis), gender, or age group. The results show that there were several problems with the scale, including misfitting items, DIF by disease, age, and gender, disordered response thresholds, and inadequate measurement of patients with mild illness. As the DLQI did not benefit from the application of Rasch analysis in its development, it is argued that a new measure of disability related to dermatological disease is required. Such a measure should use a coherent measurement model and ensure that items are relevant to all potential respondents. The current use of the DLQI as a guide to treatment selection is of concern, given its inadequate measurement properties.

The Dermatology Life Quality Index: assessing the efficacy of biological therapies for psoriasis

Clinical trials show improvement in physical and health-related quality of life (HRQoL) measures in patients with psoriasis treated with biologics compared with placebo. However, these reports only give limited interpretation of the meaning of Dermatology Life Quality Index (DLQI) scores and provide limited comparison data. The aim of this paper is to identify which biological therapy provides the greatest improvement in HRQoL following treatment of patients with chronic plaque psoriasis, as assessed by the DLQI. We reviewed all data published up to August 2006 of randomized placebo-controlled trials (RCTs) of the four biologics currently licensed in some countries for clinical use in chronic plaque psoriasis (alefacept, efalizumab, etanercept and infliximab) which have used the DLQI as an outcome measure. The DLQI data were assessed based on overall improvement according to the DLQI descriptor bands and on clinically meaningful improvement of > or = 5. Fifteen peer-reviewed articles and 59 abstracts describing 11 multicentre, double-blind RCTs were reviewed. Treatment with any one of the four biologics led to a clinically meaningful improvement in the DLQI of > or = 5. However, when applying the DLQI banding concept, infliximab and etanercept provided the greatest improvement in the overall HRQoL from a 'very large effect on overall HRQoL' at baseline to 'a small effect on overall HRQoL' following treatment. The DLQI banding concept provides a further tool to assess the impact of biologics on HRQoL of patients with psoriasis. Based on retrospective application of DLQI bands to published RCT data, infliximab, followed by etanercept, showed the greatest improvement in the overall HRQoL paralleled by a 75% improvement in the Psoriasis Area and Severity Index. However, some publications did not provide absolute baseline DLQI values, making interpretation of data and comparison between the agents difficult. Side-to-side comparative studies between biologics and between biologics and nonbiological psoriasis treatments will aid evidence-based psoriasis management decisions in the future.

Morbidity and cost of atopic eczema in Australia.

The severity, morbidity and financial costs of atopic eczema (AE) were assessed during a 1-year prospective study of a cohort of 85 people aged 14-63 years (mean 36 years) with the disease. A dermatologist examined each participant using the Six Area Six Sign Atopic Dermatitis severity scoring system to classify severity. Participants completed a Dermatology Life Quality Index (DLQI), a Nottingham Eczema Severity Score (NESS) and an ongoing diary of health-care consultations and treatment costs. Follow up by mail to each participant was conducted every 2 months and participants completed a NESS, a DLQI and a diary of costs incurred. The DLQI data revealed that 36% spent over 10 min per day applying treatments, 28% indicated that AE influenced the clothes they wore, 21% felt embarrassed by their skin and 15% reported problems with treatments. There appeared to be a relationship between increased morbidity and increased severity. The average annual out-of-pocket cost for products used for treatment was A$425, ranging from A$13.50 to over A$2000 per individual. The average out-of-pocket cost for medical consultations was A$120, ranging from zero to over A$800 per individual. Although there were concerns about the reproducibility of the severity and morbidity measures, the data showed that AE can have substantial effects both financially and from a personal perspective for those affected.