Dermatology Life Quality Index Items Research Articles

Complete Skin Clearance is Associated with the Greatest Benefits to Health-Related Quality of Life and Perceived Symptoms for Patients with Psoriasis.

With newer biologics, the achievement of complete skin clearance has become an attainable treatment goal for patients with plaque psoriasis. We evaluate how improvements in Psoriasis Area and Severity Index (PASI) responses, particularly at incremental improvements approaching complete skin clearance (PASI 100), translate into improvements in health-related quality of life (HRQoL) and patient-perceived symptoms. Data from the BE RADIANT phase 3b trial (NCT03536884) and its open-label extension (OLE), pooled across all study visits and treatments over 16weeks (randomised patients) and 2years (patients entering the OLE), were analysed using mixed-effects logistic regression models. Proportions of patients achieving a Dermatology Life Quality Index (DLQI) of 0/1, DLQI item scores of 0, and Psoriasis Symptoms and Impacts Measure (P-SIM) item scores of 0 for itching, scaling, and skin pain at specific PASI improvement levels were estimated. Seven hundred andforty-three patients were randomised to treatment; 654 entered the OLE. Using 16-week pooled data, there were incremental improvements in the proportions of patients estimated by our model to achieve DLQI 0/1 with PASI 100 compared with 95% (PASI = 95%) and 90% (PASI = 90%) improvements in PASI (93.0%, 89.3%, and 83.8% achieving DLQI 0/1, respectively). Estimated proportions achieving DLQI item scores of 0 had the greatest increases at higher PASI improvement levels for Items 1 (itchy, sore, painful, or stinging skin), 2 (embarrassment), and 4 (choice of clothing). Estimated proportions of patients achieving P-SIM = 0 were also higher for PASI 100 (itching: 61.7%; scaling: 82.2%; skin pain: 96.9%) than for PASI = 95% (50.8%; 72.3%; 95.7%) and PASI = 90% (39.8%; 59.5%; 94.0%). Similar benefits of incremental PASI improvements were estimated using 2-year data. Complete skin clearance translated into the greatest benefits to HRQoL and patient-perceived symptoms, over and above skin clearance between 90% and 100%, highlighting the importance of targeting PASI 100 as a treatment outcome for patients with psoriasis. NCT03536884. Complete skin clearance is associated with the greatest benefits to health-related quality of life and perceived symptoms for patients with psoriasis: KeyResults and Conclusions (MP4 72828 kb).

What do Hyperhidrosis Quality of Life Index (HidroQoL©) scores mean? Transferring science into practice by establishing a score banding system.

The Hyperhidrosis Quality of Life Index (HidroQoL©) is a measure of quality of life (QoL) impacts in hyperhidrosis (HH). We aimed to establish score banding systems for the HidroQoL total score for specific contexts representing different severity/impact categories by using the Dermatology Life Quality Index (DLQI) and the Hyperhidrosis Disease Severity Scale (HDSS) as anchors, including data from 357 patients from a phase III clinical trial. We used the HDSS, the established DLQI score bands and two single items (items 5 and 7) of the DLQI as anchors for the creation of banding systems for the HidroQoL. These anchors were chosen via consensus among an expert group according to relevance to patient experience. Due to the distribution of the HDSS and the single DLQI item 7, receiver operating characteristic curves were computed in order to create an optimal cut-off value of the HidroQoL total score. For the DLQI banding system and the single DLQI item 5, we created a banding system for the HidroQoL based on the distribution of their different categories. A score of 30 and greater is proposed as the cut-off value for sweating that 'always interferes in daily activities', based on the HDSS as anchor. In terms of overall skin QoL effects, score bands of 0-6, 7-18, 19-25, 26-32 and 33-36 represent 'no effect', 'small effect', 'moderate effect', 'very large effect' and 'extremely large effect' on the patient's life, respectively. In this study, we propose different banding systems for four different contexts: skin-specific QoL (DLQI banding), HH severity (HDSS), working and studying (single DLQI item 7) and social and leisure activities (single DLQI item 5). These banding systems and cut-off values can be used in clinical research and practice to place the patients in different severity categories.

Application of Dermatology Life Quality Index‐Relevant (DLQI‐R) in patients with moderate‐to‐severe plaque psoriasis treated with tildrakizumab

AbstractBackgroundTildrakizumab is an interleukin‐23p19 inhibitor approved for the treatment of moderate‐to‐severe plaque psoriasis. The new Dermatology Life Quality Index (DLQI)‐Relevant (DLQI‐R) scoring system avoids the bias in the not relevant response option of the DLQI by adjusting the total score to the relevant items.ObjectivesTo assess the impact of tildrakizumab on health‐related quality of life (HRQoL) in patients with moderate‐to‐severe psoriasis in the reSURFACE 2 phase 3 trial as measured with the original DLQI scoring and with the new DLQI‐R.MethodsPost hoc analysis of adult patients with moderate‐to‐severe plaque psoriasis from a double‐blinded, randomized, controlled, 52‐week trial. The presented analysis is based on observed cases.ResultsAt baseline, 31.9%/33.6%/40.0% of patients on tildrakizumab 100 mg/tildrakizumab 200 mg/placebo had ≥1 DLQI item marked as ‘not relevant’. The most frequently ‘not relevant’ items were ‘sport’ (14.0%/13.9%/15.5%) and ‘working/studying’ (13.4%/11.3%/12.9%), in the tildrakizumab 100 mg/tildrakizumab 200 mg/placebo groups, respectively. At baseline, 68.1%/73.0%, 60.3%/63.2% and 62.6%/65.8% of patients on tildrakizumab 100 mg, tildrakizumab 200 mg and placebo had a DLQI > 10/DLQI‐R > 10, respectively. Mean DLQI/DLQI‐R scores at baseline were 14.8/15.5, 13.3/14.1, and 14.1/15.0 in the tildrakizumab 100 mg, tildrakizumab 200 mg and placebo groups, respectively. The median change from baseline in both DLQI and DLQI‐R scores at Week 12 was greater in the tildrakizumab 100 mg and 200 mg groups versus placebo (−10.0, −9.0, −1.0 and −11.0, −9.3, −1.1, respectively). At Week 52, the median change from baseline in DLQI/DLQI‐R was −13.0/−14.0 and −10.0/−10.1 in the tildrakizumab 100 mg and 200 mg groups, respectively.ConclusionsTreatment with tildrakizumab resulted in significant and sustained improvements in HRQoL up to Week 52 in patients with moderate‐to‐severe psoriasis. The DLQI‐R provides a more unbiased HRQoL assessment ensuring that those who are unable to work/partake in sport have a truer assessment and opportunity for treatment.

A comparative study on the measurement properties of Dermatology Life Quality Index (DLQI), DLQI-Relevant and Skindex-16.

Dermatology Life Quality Index (DLQI) and Skindex-16 are among the most commonly used dermatology-specific health-related quality-of-life (HRQoL) instruments. DLQI has two common scoring methods, the original and the DLQI-Relevant (DLQI-R) modification. Head-to-head comparisons of the measurement properties of the DLQI, DLQI-R and Skindex-16 are currently lacking. We aim to compare the measurement properties of the DLQI, DLQI-R and Skindex-16. We analysed data from 618 patients with self-reported physician-diagnosed dermatological conditions from a cross-sectional survey carried out in Hungary in early 2020. DLQI, DLQI-R and Skindex-16 were compared in terms of ceiling and floor effects, informativity, convergent validity and known-group validity. Mean DLQI, DLQI-R and Skindex-16 total scores were 3·76±5·03, 4·11±5·34 and 29·36±26·62, respectively. Among patients with a DLQI/DLQI-R total score of zero, 64% reported problems on Skindex-16. Overall, 23-38% of patients with 'not relevant' responses on DLQI items 3 (shopping/home/gardening), 7 (working/studying), 8 (interpersonal problems) and 9 (sexual difficulties) reported problems on their corresponding Skindex-16 items. Average relative informativity (Shannon's evenness index) was the highest for Skindex-16 (0·85), followed by DLQI-R (0·66) and DLQI (0·54). DLQI, DLQI-R and Skindex-16 demonstrated similar convergent validity. DLQI was able to better discriminate between known groups of patients based on overall skin-related HRQoL impairment, whereas DLQI-R and Skindex-16 performed better with respect to self-perceived health status. Skindex-16 seems to be more sensitive than DLQI/DLQI-R in capturing mild impairment in HRQoL. Our findings help to provide a fuller understanding of the difference between DLQI, DLQI-R and Skindex-16 and support the informed choice of instrument for clinical and research purposes.

Validity and reliability of Patient-Reported Outcomes Measurement Information System Global Health scale in adults with atopic dermatitis

Patient-Reported Outcomes Measurement Information System Global Health (PGH) was validated to assess health-related quality of life in several diseases. Little is known about its measurement properties in adult atopic dermatitis. Examine the measurement properties of PGH in adult atopic dermatitis. A prospective dermatology practice-based study of 994 atopic dermatitis patients (18-97years). PGH physical and mental health 4-item and abridged 2-item T scores, as well as mapped EuroQol-5D score, showed strong to very strong correlation with one another and moderate to strong Spearman correlations with Patient-Oriented Scoring Atopic Dermatitis, Patient-Health Questionnaire-9, Patient-Reported Outcomes Measurement Information System sleep disturbance and related impairment, Eczema Area and Severity Index, objective Scoring Atopic Dermatitis; and weak to moderate correlations with Patient Oriented Eczema Measure, numeric rating scale worst itch and average itch, and Scoring Atopic Dermatitis. The Dermatology Life Quality Index (DLQI) had stronger correlations with Patient Oriented Eczema Measure, Patient-Oriented Scoring Atopic Dermatitis, numeric rating scale worst itch and average itch, Eczema Area and Severity Index, and Scoring Atopic Dermatitis, but weaker correlations with Patient-Health Questionnaire-9 and Patient-Reported Outcomes Measurement Information System sleep disturbance and related impairment (convergent/divergent validity). PGH and DLQI scores had similarly poor ability to differentiate between levels of self-reported global atopic dermatitis severity (known-groups validity). No floor or ceiling effects were observed. No PGH or DLQI items had differential item functioning by demographics. PGH and DLQI scores showed fair to good responsiveness. Finally, PGH and DLQI showed similarly good test-retest reliability. Single-center study. PGH scores had sufficient validity and reliability to assess health-related quality of life in atopic dermatitis.

Using the Dermatology Life Quality Index to Assess How Breast Radiodermatitis Affects Patients' Quality of Life.

Purpose:The purpose of this study is to report the initial validation process for using the Dermatology Life Quality Index (DLQI) for radiodermatitis of the breast.Methods:This is an additional analysis of a study designed to report a longitudinal study in skin-related and global quality of life in women with breast radiodermatitis. A total of 40 participants completed the DLQI instrument weekly while receiving external radiotherapy of the female breast. At week 5 on treatment, 31 (78%) participants provided narrative feedback on how each DLQI item affected her life. Agreement between participant DLQI numerical ratings and narrative feedback on items was assessed. Construct validity was estimated using principal component analysis (PCA). Internal consistency of the DLQI was assessed using Cronbach alpha.Results:Percentage of agreement between participant DLQI ratings and narratives ranged from 71% to 98%. Each participant responded “no” to the work and study item leading to zero variance and removal from our analyses. Principal component analysis supported the inclusion of all of the remaining items. The DLQI with nine remaining items demonstrated moderately good internal consistency (α = .69).Conclusions:The results of our examination of the DLQI when used for breast radiodermatitis are promising. Next steps include additional larger studies among more diverse populations.

Ixekizumab Improved Patient-Reported Genital Psoriasis Symptoms and Impact of Symptoms on Sexual Activity vs Placebo in a Randomized, Double-Blind Study

IntroductionGenital psoriasis (GenPs) is common and distressing for patients, but is often not discussed with physicians, and no previous clinical trials have assessed the effects of biologics specifically on GenPs and its associated symptoms. AimTo report results for novel patient-reported outcomes (PROs) for the assessment of symptoms and the sexual impact of GenPs before and after treatment in the IXORA-Q study. MethodsIXORA-Q (NCT02718898) was a phase III, randomized, double-blind, placebo-controlled study of ixekizumab (80 mg/2 weeks after 160-mg initial dose) vs placebo for GenPs. Men and women ≥18 years old with moderate-to-severe GenPs and body surface area (BSA) ≥1% were assessed through 12 weeks. Main Outcome MeasureGenPs symptoms were assessed using the 8-item Genital Psoriasis Symptoms Scale (GPSS), Genital Psoriasis Sexual Frequency Questionnaire (GenPs-SFQ), and Genital Psoriasis Sexual Impact Scale (GPSIS) (validation data presented in the supplemental materials), and the Dermatology Life Quality Index (DLQI) item 9. ResultsFor patients receiving ixekizumab (N = 75) vs placebo (N = 74), statistically significant improvement in GenPs symptoms were seen from week 1 onward (GPSS total and individual items, all P < .005). Sexual activity avoidance owing to GenPs symptoms (GPSIS) decreased significantly with ixekizumab from week 4 onward (all P <.005), whereas impact of sexual activity on GenPs improved significantly with ixekizumab at weeks 2–8 (all P < 0.05). Ixekizumab resulted in significant improvement vs placebo by week 1 onward in limitations on frequency of sexual activity owing to GenPs (GenPs-SFQ item 2). Sexual difficulties caused by skin (DLQI item 9) decreased significantly with ixekizumab from week 2 onward (all P < .001). Clinical ImplicationsBoth GenPs symptoms and impact on sexual activity improved rapidly and significantly with ixekizumab vs placebo through 12 weeks in patients with moderate-to-severe GenPs and BSA ≥1%. Strength & LimitationsTo our knowledge, this is the first phase III, randomized, placebo-controlled, double-blinded clinical trial to evaluate the effect of any treatment on the symptoms and sexual impact related to GenPs. The study did not include an active comparator owing to the lack of any well-established treatment for moderate-to-severe GenPs, and the period assessed herein was of relatively short duration. ConclusionThese validated PRO measures may aid in future clinical studies of GenPs and in facilitating discussions of GenPs symptoms and their impact between patients and clinicians.Yosipovitch G, Foley P, Ryan C. Ixekizumab improved patient-reported genital psoriasis symptoms and impact of symptoms on sexual activity vs placebo in a randomized, double-blind study. J Sex Med 2018;15:1645–1652.

Does the Dermatology Life Quality Index (DLQI) underestimate the disease-specific burden of psoriasis patients?

The Dermatology Life Quality Index (DLQI) is the most frequently used health-related quality of life (HRQoL) instrument for skin diseases. According to the DLQI instructions, the responses 'not relevant' and 'my skin problem has not at all affected this aspect of life' ('not at all') have to be scored as 0=no HRQoL impairments. The aim of this study was to estimate potential bias of DLQI measurements for patients with psoriasis based on items considered to be not relevant. One thousand two hundred forty-three patients with psoriasis were surveyed in a cross-sectional study. Disease severity (Psoriasis Area and Severity Index, PASI) and subjective health state (EuroQoL Visual Analogue Scale, EQ VAS) were compared per DLQI item between patients who answered the respective question 'not relevant' and those who answered 'not at all'. Patients who declared a DLQI item to be not relevant showed a higher disease severity and a lower health state. Results indicate that patients who declare a DLQI item to be not relevant have a higher disease-related burden than those who do not feel affected by their psoriasis in the same aspect of life. If aspects of life are considered to be not relevant due to high disease burden, this should be reflected by a HRQoL instrument.

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.

Measurement Properties of the Psoriasis Symptom Inventory Electronic Daily Diary in Patients with Moderate to Severe Plaque Psoriasis.

The Psoriasis Symptom Inventory (PSI) is a patient-reported outcome instrument that measures the severity of psoriasis signs and symptoms. This study evaluated measurement properties of the PSI in patients with moderate to severe plaque psoriasis. This secondary analysis used pooled data from a phase 3 brodalumab clinical trial (AMAGINE-1). Outcome measures included the PSI, Psoriasis Area and Severity Index (PASI), static Physician's Global Assessment (sPGA), psoriasis-affected body surface area, 36-item Short-Form Health Survey version 2, and the Dermatology Life Quality Index (DLQI). The PSI was evaluated for dimensionality, item performance, reliability (internal consistency and test-retest), construct validity, ability to detect change, and agreement between PSI response and response measures based on the PASI, sPGA, and DLQI. Results supported unidimensionality, good item fit, ordered responses, and PSI scoring. The PSI demonstrated reliability: baseline Cronbach's alpha ≥ 0.92 and intraclass correlation coefficients ≥ 0.95. Correlations between PSI total score and DLQI item 1 (r = 0.86), DLQI symptoms and feelings (r = 0.87), and 36-item Short-Form Health Survey version 2 bodily pain (r = -0.61) supported convergent validity. PSI scores differed significantly (P < 0.001) among severity groups based on the PASI (< 12/≥ 12), sPGA (0-1/2-3/4-5), body surface area (< 5%/5%-10%/> 10%), and DLQI (≤ 5/> 5) at weeks 8 and 12. At week 12, the PSI detected significant changes in severity based on PASI responses (< 50/50- < 75/≥ 75) and sPGA (0-1/≥ 2), and showed good agreement (k ≥ 0.66) between PSI response and PASI, sPGA, and DLQI responses. The PSI demonstrated excellent validity, reliability, and ability to detect change in the severity of psoriasis signs and symptoms.

Validation of the Psoriasis Symptom Inventory (PSI), a patient-reported outcome measure to assess psoriasis symptom severity

Background: The objective of this study was to evaluate the measurement properties of the Psoriasis Symptom Inventory (PSI), an eight-item patient-reported outcome measure for assessing severity of plaque psoriasis symptoms. Methods: In this prospective, randomized study using data from adults with moderate-to-severe plaque psoriasis, patients completed the PSI, Dermatology Life Quality Index (DLQI), SF-36v2 Acute, and Patient Global Assessment (PtGA). PSI construct validity was assessed using Spearman rank correlations between PSI and DLQI and SF-36; test-retest reliability and sensitivity to change were evaluated using PtGA as an anchor. Daily 24-h and weekly 7-day PSI versions were evaluated. Results: Eight US sites enrolled 143 patients; 139 (97.2%) completed the study. All symptoms (itch, redness, scaling, burning, cracking, stinging, flaking, and pain) were reported across all response options (not at all severe, mild, moderate, severe, very severe). Test-retest reliability was acceptable (intraclass correlation coefficients range = 0.70–0.80). A priori hypotheses of convergent and discriminant validity were confirmed by correlations of PSI with DLQI items and SF-36 domains. The PSI demonstrated good construct validity and was sensitive to within-subject change (p < 0.0001). Conclusions: The PSI is brief, valid, reproducible, and responsive to change and has the potential to be a useful PRO measure in psoriasis clinical trials.

Validation of the Dermatology Life Quality Index as an outcome measure for urticaria-related quality of life

Chronic idiopathic urticaria (CIU) is a debilitating skin disease that affects patients' quality of life (QOL). The Dermatology Life Quality Index (DLQI) assesses QOL parameters across several types of dermatologic conditions. However, an evaluation of the validity of the DLQI for use in CIU patients has not been undertaken, because CIU, unlike other chronic skin conditions, is subject to daily or weekly symptom fluctuations. To test the reliability and validity of the DLQI in 2 samples of CIU patients treated with fexofenadine hydrochloride (20, 60, 120, or 240 mg twice daily). Data were obtained from 2 similar multicenter, double-blind, randomized, placebo-controlled, parallel-group studies of CIU patients (n = 418 and n = 439). Patients completed the 10-item DLQI during 3 clinic visits (approximately 2 weeks apart). Clinic personnel also recorded patients' symptoms. The results of the DLQI items were similar to those obtained with other skin disease populations, indicating the presence of relatively symmetrical distributions. Reliability was high, demonstrating the lack of excessive random measurement error (alpha coefficient = .89 and .87 for samples 1 and 2). Factor analysis resulted in a unidimensional pattern, supporting the use of a total DLQI score. Most DLQI items distinguished patients with varying degrees of QOL impairment, highlighting the sensitivity of this instrument. Construct validity was moderate, providing evidence that the DLQI was responsive to changes in patients' clinical status. The DLQI is a valid, reliable, and clinically useful outcome measure for assessing QOL in CIU patients.

Factors affecting responses on Dermatology Life Quality Index items among vitiligo sufferers

Finlay and Khan have recently suggested that the Dermatology Life Quality Index (DLQI) can be used to measure the effects of dermatological conditions on the quality of patients' lives. The aims of this study were to assess its applicability in a nonclinic sample of vitiligo sufferers and to measure its relationship with questionnaires designed to measure a variety of psychological and demographic factors. The DLQI was completed by 614 members of the Vitiligo Society in a postal survey. The results supported the validity of the DLQI for this sample. DLQI scores were related to perceived stigma (a version of Ginsburg and Link's psoriasis stigma questionnaire), recent experiences, self-esteem (Rosenberg's scale), personal distress (both a symptom checklist and the 12-item General Health Questionnaire) and race, suggesting that levels of disability might be reduced by interventions that target these variables.

Factors affecting responses on Dermatology Life Quality Index items among vitiligo sufferers

Factors affecting responses on Dermatology Life Quality Index items among vitiligo sufferers