Responsiveness and Minimal Clinically Important Difference of the Infants and Toddlers Dermatology Quality of Life Questionnaire.

BACKGROUND: The Infants and Toddlers Dermatology Quality of Life (InToDermQoL) is the dermatology-specific proxy health-related quality of life (HRQoL) instrument for children from birth to 4 years. The aim of the present study was to confirm the responsiveness and establish minimal clinically important difference (MCID) for the InToDermQoL. METHODS: Parents of children with skin diseases were asked to fill in the InToDermQoL at the initial visit (T1) and subsequent consultation (T2). We hypothesized that correlations between change scores of the InToDermQoL and change scores of global assessment of clinical severity by dermatologists and by patients' parents should be above 0.3. The receiver operating characteristic (ROC) curves method was also used for confirmation of responsiveness and determination of MCIDs of the InToDermQoL. The area under the ROC curve (AUC) was used as an indicator of responsiveness. RESULTS: Results of 442 patients were included. Correlations between change scores of age-specific versions of the InToDermQoL and change scores of global assessment of clinical severity by dermatologists and by patients' parents were above 0.3 (0.46-0.74). AUCs for age-specific versions of the InToDermQoL were acceptable (above 0.7) or excellent (above 0.8). Estimated MCIDs for the InToDermQoL were as follows: 3 points of total score change for 0-11 months, 5 for 1-2 years and 3 or 4 for 3-4 years version. Estimated MCIDs for the InToDermQoL version for 1-2-year-old children was higher than MCIDs for the 3-4-year-old version despite the higher number of items in the latter. Therefore a MCID of 5 was recommended for both these versions. CONCLUSIONS: Responsiveness for all age-specific versions of the InToDermQoL questionnaire was confirmed. MCIDs for the InToDermQoL are proposed as follows: 3-point change of the total score for age version 0-11 months and 5-point for the age versions 1-2 years and 3-4 years.

Perceived Stigmatization among Dermatological Outpatients Compared with Controls: An Observational Multicentre Study in 17 European Countries.

Perceived stigmatization places a large psychosocial burden on patients with some skin conditions. Little is known about the experience of stigmatization across a wide range of skin diseases. This observational cross-sectional study aimed to quantify perceived stigmatization and identify its predictors among patients with a broad spectrum of skin diseases across 17 European countries. Self-report questionnaires assessing perceived stigmatization and its potential predictors were completed by 5,487 dermatology outpatients and 2,808 skin-healthy controls. Dermatological diagnosis, severity, and comorbidity were clinician-assessed. Patients experienced higher levels of perceived stigmatization than controls (p < 0.001, d = 0.26); patients with psoriasis, atopic dermatitis, alopecia, and bullous disorders were particularly affected. Multivariate regression analyses showed that perceived stigmatization was related to sociodemographic (lower age, male sex, being single), general health-related (higher body mass index, lower overall health), disease-related (higher clinician-assessed disease severity, presence of itch, longer disease duration), and psychological (greater distress, presence of suicidal ideation, greater body dysmorphic concerns, lower appearance satisfaction) variables. To conclude, perceived stigmatization is common in patients with skin diseases. Factors have been identified that will help clinicians and policymakers to target vulnerable patient groups, offer adequate patient management, and to ultimately develop evidence-based interventions.

Sensitivity to treatment and score bands of the Infants and Toddlers Dermatology Quality of Life questionnaire.

Background: The Infants and Toddlers Dermatology Quality of Life (InToDermQoL) questionnaire is the first dermatology-specific proxy health related QoL instrument for children from birth to 4 years. Score meaning bands and the sensitivity to successful therapeutic intervention are important to interpret the clinical meaning of an instrument. Objective: The aim of the present study was to check the sensitivity to successful therapeutic intervention and establish score bands of the InToDermQoL questionnaire. Methods: Parents or grandparents of 424 children with skin diseases from Spain, Malta, Croatia, Romania, Greece, and Ukraine filled in national language versions of the InToDermQoL questionnaire. Disease severity of children with atopic dermatitis was assessed by SCORAD (Scoring atopic dermatitis). Cohen's d was used to assess the responsiveness of the instrument. Results: The mean total InToDermQoL scores significantly decreased after treatment. Severity grading of the SCORAD scores gave stratification of the InToDermQoL severity grades based on 95% confidence intervals. Scores below a calculated minimal important difference of 2 corresponded to no effect on patient's health related QoL. Limitations: Score banding may be slightly different across patient population and study context. Conclusion: All 3 age-specific versions of the InToDermQoL questionnaire showed sensitivity to treatment. Score bands for the InToDermQoL questionnaire have been established.

Quality of life measurement in vitiligo. Position statement of the European Academy of Dermatology and Venereology Task Force on Quality of Life and Patient Oriented Outcomes with external experts.

Members of the European Academy of Dermatology and Venereology (EADV) Task Force on Quality of Life (QoL) and Patient Oriented Outcomes reviewed the instruments available for health-related (HR) QoL assessment in vitiligo and together with external vitiligo experts (including representatives of the EADV Vitiligo Task Force) have made practical recommendations concerning the assessment of QoL in vitiligo patients. The Dermatology Life Quality Index (DLQI) was the most frequently used HRQoL instrument, making comparison of results between different countries possible. Several vitiligo-specific instruments were identified. The vitiligo Impact Scale (VIS) is an extensively validated vitiligo-specific HRQoL instrument with proposed minimal important change and clinical interpretation for VIS-22 scores. VIS-22 was developed for use in India, where there are some specific cultural beliefs concerning vitiligo. The EADV Task Force on QoL and Patient Oriented Outcomes recommends use of the DLQI and the Children's Dermatology Life Quality Index (CDLQI) as dermatology-specific instruments in vitiligo. There is a strong need for a valid (including cross-cultural validation) vitiligo-specific instrument that can be either a new instrument or the improvement of existing instruments. This validation must include the proof of responsiveness.

Which Health-Related Quality of Life Items Most Affect Acne Patients?

BACKGROUND: Health-related quality of life (HRQoL) assessment in patients with acne is recommended by several national guidelines. There are several acne-specific HRQoL instruments. OBJECTIVES: Participants of the European Academy of Dermatology and Venereology (EADV) Task Forces (TFs) on QoL and Patient Oriented Outcomes (PO) and Acne, Rosacea, and Hidradenitis Suppurativa (ARHS) agreed to scrutinize aspects of existing acne-specific HRQoL instruments for their relevance in international study. METHODS: Consensus agreement on items related to QoL was reached after an independent assessment by seven experts from the EADV TFs on QoL and PO, and a list of 97 items was prepared and proposed to a group of acne patients. In order to have data from patients to check if any important topics were overseen, another group of acne patients from participating countries was asked to list how acne influenced different aspects of their lives. RESULTS: Based on results obtained from 601 acne patients from nine countries, most of the items and topics showed low relevance for acne patients especially during the previous month or shorter time periods. Based on percentage of relevance and factor analysis, short (6 items) and long (45 items) lists of the most relevant topics were formed. CONCLUSION: Most of the items and topics from the initial list showed low relevance for acne patients. None of the identified acne-specific HRQoL instruments contain all the items that were deemed most relevant to acne patients. For this reason, participating members of the EADV TFs on QoL and PO, and ARHs are in the process of developing a new acne-specific HRQoL instrument.

Self-Reported Hidradenitis Suppurativa Severity: Is It Useful for Clinical Practice?

INTRODUCTION: Hidradenitis suppurativa (HS) is considered to be the most burdensome dermatosis, with a well-documented negative influence on quality of life (QoL). The patient's perception of the disorder, assessed as the self-reported severity, has been used in other dermatoses but not in HS. The aim of this study was to evaluate the usefulness of self-reported HS severity in clinical practice. METHODS: The study was performed on a group of 130 Spanish HS patients. HS severity was assessed for all the subjects. Hurley staging and patient self-reported severity were used. Moreover, QoL impairment was evaluated using the Dermatology Life Quality Index (DLQI) and the Hidradenitis Suppurativa Quality of Life 24 (HSQoL-24) questionnaire. RESULTS: The severity of HS according to the Hurley staging was most commonly assessed as Hurley II (47.7%), indicating moderate disease, followed by severe disease (Hurley III, 26.9%) and mild disease (Hurley I, 25.4%). According to the patient self-reported HS severity, most of the patients reported having mild disease (76 patients, 58.5%), followed by moderate disease (31 patients, 23.8%). Only 23 patients (17.7%) assessed their disease as severe. Moreover, men reported mild disease significantly more frequently than women (70.9% and 49.3%, respectively; p = 0.014). The self-reported HS severity correlated positively with the effect of the disease on patient QoL assessed with DLQI (r = 0.288, p < 0.001). Likewise, a strong positive correlation was found between self-reported HS severity and QoL impairment assessed with HSQoL-24 (r = 0.404, p = 0.001). No statistically significant correlation between Hurley severity stage and DLQI or HSQoL-24 was found. Moreover, there were significant differences in both DLQI and HSQoL-24 total score between different self-reported HS severities. This was not seen for any of the QoL instruments or for Hurley severity staging. CONCLUSION: The results show that self-assessment severity may reflect patients' subjective feelings more adequately than popular objective instruments, and there should be a place for its use in daily clinical practice.

Body dysmorphia in common skin diseases: results of an observational, cross-sectional multicentre study among dermatological outpatients in 17 European countries.

BACKGROUND: Body dysmorphic disorder (BDD) is a common psychiatric disorder associated with high costs for healthcare systems as patients may repeatedly ask for different, often not effective, interventions. BDD symptoms are more prevalent in patients with dermatological conditions than in the general population, but there are no large sample studies comparing the prevalence of BDD symptoms between patients with dermatological conditions and healthy skin controls. OBJECTIVES: To compare the prevalence of BDD symptoms between patients with different dermatological conditions and healthy skin controls and to describe sociodemographic, physical and psychological factors associated with BDD symptoms to identify patients who may have a particularly high chance of having this condition. METHODS: This observational, cross-sectional, comparative multicentre study included 8295 participants: 5487 consecutive patients with different skin diseases (56% female) recruited among dermatological outpatients at 22 clinics in 17 European countries, and 2808 healthy skin controls (66% female). BDD symptoms were assessed by the Dysmorphic Concern Questionnaire. Sociodemographic data and information on psychological factors and physical conditions were collected. Each patient was given a dermatological diagnosis according to ICD-10 by a dermatologist. The study was registered with number DRKS00012745. RESULTS: The average participation rate of invited dermatological patients was 82.4% across all centres. BDD symptoms were five times more prevalent in patients with dermatological conditions than in healthy skin controls (10.5% vs. 2.1%). Patients with hyperhidrosis, alopecia and vitiligo had a more than 11-fold increased chance (adjusted Odds Ratio (OR) > 11) of having BDD symptoms compared with healthy skin controls, and patients with atopic dermatitis, psoriasis, acne, hidradenitis suppurativa, prurigo and bullous diseases had a more than sixfold increased chance (adjusted OR > 6) of having BDD symptoms. Using a logistic regression model, BDD symptoms were significantly related to lower age, female sex, higher psychological stress and feelings of stigmatization. CONCLUSIONS: Clinical BDD symptoms are significantly associated with common dermatological diseases. As such symptoms are associated with higher levels of psychological distress and multiple unhelpful consultations, general practitioners and dermatologists should consider BDD and refer patients when identified to an appropriate service for BDD screening and management.

Hidradenitis Suppurativa Quality of Life 24 (HSQoL-24) now available for Polish patients: creation and validation of the Polish language version.

Introduction: Hidradenitis suppurativa (HS) is a chronic, inflammatory skin disorder with a well-documented impact on quality of life (QoL). Due to the very distinctive features of HS the clinical picture, and lack of specific questions, generic dermatology QoL questionnaires cannot adequately reflect patients' suffering. Aim: To translate and validate the Polish version of the Hidradenitis Suppurativa Quality of Life 24 (HSQoL-24) questionnaire. Material and methods: The standardized translation process included forward and backward translation from the English version of the instrument. The final version was subsequently validated on a group of 30 HS patients, who completed the questionnaire twice. Internal consistency, test-retest reliability, and reproducibility of the results were also analysed. Results: The Polish version of HSQoL-24 showed excellent internal consistency, with a Cronbach α coefficient of 0.908. Moreover, excellent reproducibility of the results was observed, with an intraclass correlation coefficient of 0.908. The HSQoL global score correlated positively with Dermatology Life Quality Index (DLQI) and Hidradenitis Suppurativa Quality of Life (HiSQoL) questionnaire. Conclusions: The Polish version of HSQoL-24 has excellent internal consistency, good reproducibility, and adequate validity. It may be of help in assessing QoL impairment in HS patients in daily practice and research.

The Use of HSQoL-24 in an Assessment of Quality-of-Life Impairment among Hidradenitis Suppurativa Patients: First Look at Real-Life Data.

Hidradenitis suppurativa (HS) is a chronic inflammatory skin disorder with well-documented effects on patients' quality of life (QoL). The aim of this study was to evaluate the QoL of patients with HS via the use of a newly developed questionnaire: Hidradenitis Suppurativa Quality of Life-24 (HSQoL-24). This study was performed on a population of 342 HS patients. Their QoL was assessed via the HSQoL-24 questionnaire. The perceived impairment of QoL due to HS in the studied group was considered to be serious (mean HSQoL-24 score: 58.3 ± 21.0 points). Women tended to experience a significantly higher impact from the disease than men (61.6 ± 19.2 points vs. 51.1 ± 23.1 points, p < 0.001). The HS severity had an effect on the perceived QoL, with statistically significant differences being evident between the self-assessed HS severity groups. The level of QoL impairment correlated positively with the number of affected body areas (r = 0.285, p < 0.001) and the duration of the disease (r = 0.173, p = 0.001), while the patients' age at disease onset correlated negatively with the HSQoL-24 global score (r = -0.182, p = 0.001). Patients living in their family house scored higher than other groups. The least affected were patients who lived alone. The study shows that the HSQoL-24 questionnaire is a reliable, HS-specific tool for measuring the QoL among patients with HS in real-life clinical settings.

Quality of Life in Hidradenitis Suppurativa: validation of the HSQoL-24.

To date, there are no disease-specific instruments in Spanish to assess quality of life of patients with hidradenitis suppurativa. A multicentre study was previously carried out in Spain between 2016 and 2017 to develop the Hidradenitis Suppurativa Quality of Life-24 (HSQoL-24), a disease-specific questionnaire to assess quality of life in patients with hidradenitis suppurativa. The objectiv-es of this study are to revalidate the HSQoL-24 in Spanish with a larger sample of patients, and to present the English version. In this multi-centre study in Spain, patients with hidradenitis suppurativa completed the HSQoL-24, the Dermatology Life Quality Index and the Skindex-29. The Hurley staging system was used to assess the severity of the disease. Validation of the questionnaire was carried out in 130 patients, of whom 75 (57.7%) were women. This study demonstrates adequate values of reliability and validity of the HSQoL-24, confirming the previous test re-test validation and making this questionnaire one of wide clinical validity in terms of results perceiv-ed by patients.

Patient Reported Outcome Measure in Atopic Dermatitis Patients Treated with Dupilumab: 52-Weeks Results.

Dupilumab is used to treat atopic dermatitis (AD) patients who have proven to be refractory to previous treatments. The aim of this study was to assess evolution and patient reported outcome measures in adult patients with moderate-to-severe AD treated with dupilumab in routine clinical practice. The outcomes were evaluated and registered at baseline and weeks 16, 40 and 52. The variables evaluated were: disease severity, pruritus, stressful life events, difficulty to sleep, anxiety and depression, quality of life, satisfaction, adherence to the treatment, efficacy and safety. Eleven patients were recruited between 14 Nov 2017 and 16 Jan 2018. Demographic variables: 90% Caucasian, 82% women. Clinical variables: Mean duration of AD = 17.7 (±12.8), 91% had severe disease severity. At baseline, SCORAD median (range) score = 69.2 (34.8-89.2); itch was reported by 100% of patients; itch visual analogue scale median (range) was 9 (6-10); HADS median (range) total score = 13 (5-21); DLQI mean score = 16 (2-27); EQ-5D-3L median (range) = 57 (30-99). At week-52 there was a significant reduction of SCORAD scores median (range) = 4.3 (0-17.1), HADS total score median (range) = 2 (0-10) and improved quality of life EQ-5D-3L median (range) = 89 (92-60). This study confirms that dupilumab, used for 52-weeks under routine clinical practice, maintains the improved atopic dermatitis signs and symptoms obtained at week 16, with a good safety profile.

Quality of Life in Hidradenitis Suppurativa: An Update.

Knowledge on hidradenitis suppurativa/acne inversa (HS) is rapidly increasing. HS has a profound impact on patients and their family life. Several factors, such as comorbidities, unemployment and HS severity, make this impact even more severe. The most widely used instrument to measure this impact is the dermatology-specific DLQI. We also identified six HS-specific health-related quality of life (HRQoL) instruments. Of them, HIDRAdisk, HSIA, HiSQOL and HSQoL-24 are better validated but there is still lack of experience of its use. Several treatment methods showed positive effect on patients' HRQoL. Surgery remains a method with a substantial positive effect on HRQoL. Several studies confirming a positive effect of adalimumab on the HRQoL of patients with HS were published during the last three years. Data on the influence of several other biologics on HRQoL of HS patients are controversial or based on studies with a small number of patients.

Initial validation of the epidermolysis bullosa-specific module of the Infants and Toddlers Dermatology Quality of Life questionnaire.

Children with epidermolysis bullosa (EB) experienced the highest quality of life impact among several skin conditions and have problems which had not been reported by parents of children with other skin diseases. The EB-specific module of the Infants and Toddlers Dermatology Quality of Life (InToDermQoL) questionnaire was recently developed to measure the impact of disease-specific aspects in children from birth to the age of 4 years. The aim of this study was initial validation of the InToDermQoL-EB questionnaire. Parents of 44 children with EB from seven countries completed the InToDermQoL-EB questionnaire. Cronbach's alpha was .86, .89 and .91 for three age-specific versions. Differences between severity levels were all significant except for that between moderate and severe level in the version for 3- to 4-year-old children. All items of the three versions of the InToDermQoL-EB showed very high levels of relevance except "problems with defecation" in children younger than 1 year and "rejection by other children" in 3- to 4-year-old children. The three versions of the InToDermQoL-EB instrument showed good internal consistency and discriminated well between different severity levels. All InToDermQoL-EB items were confirmed as being of high relevance and the questionnaire may be used in practice and clinical trials.

Exploring the EQ-5D Dimension of Pain/Discomfort in Dermatology Outpatients from a Multicentre Study in 13 European Countries.

Pain and discomfort are important symptoms in dermatology. The aim of this cross-sectional, multicentre study was to describe the prevalence of pain/discomfort and its associations in patients with several dermatological conditions across 13 European countries. The outcome was the prevalence of pain/discomfort according to a question of the EQ-5D questionnaire. Data collected from November 2011 to February 2013 were complete for 3,509 consecutive outpatients. Moderate or extreme pain/discomfort was reported by 55.5% of patients and 31.5% of controls with no skin conditions. The highest proportions were reported by patients with hidradenitis suppurativa (92.9%), leg ulcer (81.4%), prurigo (80%) and lichen planus (75.6%). Pain/discomfort was associated with older age, low educational level, clinical severity, flare on scalp or hands, itch, depression, anxiety, low quality of life, and thoughts of suicide. It is important to enquire specifically about pain/discomfort during clinical consultations and to address it when planning a patient's care.

Psychosocial Aspects of Adult Acne: Data from 13 European Countries.

The link between acne and psychiatric morbidities has been demonstrated in many studies; however, large scale studies aiming to reveal the psychosocial impact of acne are rare. The aim of this study was to assess the psychological burden of adult acne patients. This analysis was based on a multicenter study including 213 acne patients and 213 controls from 13 European countries. The Hospital Anxiety and Depression Scale (HADS), Dermatology Life Quality Index, and EuroQol 5 dimensions 3 levels scores of the patients with acne were analyzed. Patients with acne (n = 213) had higher HADS scores for anxiety (mean ± standard deviation 6.70 ± 3.84) and depression (3.91 ± 3.43) than the controls (p < 0.001 for both). For patients with acne, 40.6% reported that they were very concerned about their skin disease, 12.3% had suicidal ideation, and, among those, 10 (4%) patients implied that acne was the cause of their suicidal thoughts. After adjusting for other variables, patients who had suicidal ideation (p = 0.007, and adjusted odds ratio 3.32 [95% confidence interval (CI): 1.39-7.93]) and stressful life events (p < 0.001, and adjusted OR 5.85 [95% CI: 2.65-12.86]) had a greater chance of fulfilling the HADS criteria for anxiety. This study highlights the need for a psychotherapeutic approach in order to recognize the concerns of acne patients and optimize their treatment.

Itch and Mental Health in Dermatological Patients across Europe: A Cross-Sectional Study in 13 Countries.

Itch is a highly prevalent and multidimensional symptom. We aimed to analyze the association between itch and mental health in dermatological patients. This multicenter study is observational and cross-sectional and was conducted in dermatological clinics across 13 European countries. A total of 3,530 patients and 1,094 healthy controls were included. Patients were examined clinically. Outcome measures were itch (presence, chronicity, and intensity), the Hospital Anxiety and Depression Scale, EQ-5D visual analogue scale, sociodemographics, suicidal ideation, and stress (negative life events and economic difficulties). Ethical approval was obtained. Results showed significant association between the presence of itch in patients and clinical depression (odds ratio, 1.53; 95% confidence interval, 1.15-2.02), suicidal ideation (odds ratio, 1.27; 95% confidence interval, 1.01-1.60), and economic difficulties (odds ratio, 1.24; 95% confidence interval, 1.10-1.50). The mean score of reported generic health status assessed by the EQ-5D visual analogue scale was 65.9 (standard deviation = 20.1) in patients with itch, compared with 74.7 (standard deviation = 18.0) in patients without itch (P < 0.001) and 74.9 (standard deviation = 15.7) in controls with itch compared with 82.9 (standard deviation = 15.6) in controls without itch (P < 0.001). Itch contributes substantially to the psychological disease burden in dermatological patients, and the management of patients should include access to multidisciplinary care.

Quality-of-Life Research in Acne Vulgaris: Current Status and Future Directions.

Acne patients may have significant quality-of-life (QoL) impairment, therefore assessment of health-related QoL (HRQoL) in acne patients is recommended by several national and international guidelines as an integral part of acne management. The inclusion of QoL assessment in core outcome sets is now a popular idea. Several acne-specific QoL questionnaires are available but none cover all topics presented in other instruments. The impact of acne on different aspects of QoL may vary between patients from different age groups. The European Academy of Dermatology and Venereology Task Force on Quality of Life and Patient Oriented Outcomes has initiated a study on the relevance of the different QoL topics in acne patients. Detailed recommendations on treatment goals and changes of treatment approaches based on a validated banding system and a minimal clinically important difference in HRQoL questionnaires (such as the Dermatology Life Quality Index) may be an important and promising approach.