Quality of life measurement in urticaria: Position statement of the European Academy of Dermatology and Venereology Task Forces on Quality of Life and Patient-Oriented Outcomes and Urticaria and Angioedema.

The European Academy of Dermatology and Venereology (EADV) Task Forces on quality of life (QoL) and patient-oriented outcomes and on urticaria and angioedema recommendations for the assessment of Health-related (HR) QoL in all patients with urticaria in research and practice are as follows: to use the DLQI for adults and the CDLQI for children as dermatology-specific and the CU-Q2oL as a disease-specific HRQoL instruments in urticaria; to use generic instruments to provide comparison of data on urticaria with non-dermatologic diseases, or to compare with healthy volunteers or the general population; to select validated HRQoL instruments with appropriate age limits; to present exact numeric data for HRQoL results; correct title of any HRQoL instrument should be used, along with its correct abbreviation and the reference to its original publication, where possible. The EADV TFs discourage the use of non-validated HRQoL instruments and modified HRQoL instruments that have not undergone standard validation.

Dermatological patients with itch report more stress, stigmatization experience, anxiety and depression compared to patients without itch: Results from a European multi-centre study.

BACKGROUND: Itch as the most common symptom in dermatology has been shown to be related to psychological factors such as stress, anxiety and depression. Moreover, associations were found between perceived stigmatization and itch. However, studies investigating the differences between patients with dermatoses with and without itch regarding perceived stress, stigmatization, anxiety and depression are missing. Therefore, one of the aims of the second study of the European Society for Dermatology and Psychiatry (ESDaP study II) was to investigate these relationships in a large cohort of patients with different itchy dermatoses. RESULTS: 3399 patients with 14 different itchy dermatoses were recruited at 22 centres in 17 European countries. They filled in questionnaires to assess perceived stigmatization, stress, signs of clinically relevant anxiety or depression, itch-related quality of life, the overall health status, itch duration, frequency and intensity. The most significant association between the severity of itching and the perception of stress was observed among individuals with rosacea (correlation coefficient r = 0.314). Similarly, the strongest links between itch intensity and experiences of stigmatization, anxiety, and depression were found in patients with seborrheic dermatitis (correlation coefficients r = 0.317, r = 0.356, and r = 0.400, respectively). Utilizing a stepwise linear regression analysis, it was determined that within the entire patient cohort, 9.3% of the variation in itch intensity could be accounted for by factors including gender, levels of anxiety, depression, and perceived stigmatization. Females and individuals with elevated anxiety, depression, and perceived stigmatization scores reported more pronounced itch intensities compared to those with contrary attributes. CONCLUSION: This study underscores the connection between experiencing itch and its intensity and the psychological strain it places on individuals. Consequently, psychological interventions should encompass both addressing the itch itself and the interconnected psychological factors. In specific cases, it becomes imperative for dermatologists to direct individuals towards suitable healthcare resources to undergo further psychological assessment.

Quality of life measurement in teledermatology. Position statement of the European Academy of Dermatology and Venereology Task Forces on Quality of Life and Patient Oriented Outcomes and Teledermatology.

Many events, including the COVID-19 pandemic, have accelerated the implementation of teledermatology pathways within dermatology departments and across healthcare organizations. Quality of Life (QoL) assessment in dermatology is also a rapidly developing field with a gradual shift from theory to practice. The purpose of this paper organized jointly by the European Academy of Dermatology and Venereology (EADV) Task Force (TF) on QoL and patient-oriented outcomes and the EADV TF on teledermatology is to present current knowledge about QoL assessment during the use of teledermatology approaches, including data on health-related (HR) QoL instruments used in teledermatology, comparison of influence of different treatment methods on HRQoL after face-to-face and teledermatology consultations and to make practical recommendations concerning the assessment of QoL in teledermatology. The EADV TFs made the following position statements: HRQoL assessment may be an important part in most of teledermatology activities; HRQoL assessment may be easily and effectively performed during teledermatology consultations. It is especially important to monitor HRQoL of patients with chronic skin diseases during lockdowns or in areas where it is difficult to reach a hospital for face-to-face consultation; regular assessment of HRQoL of patients with skin diseases during teledermatology consultations may help to monitor therapy efficacy and visualize individual patient's needs; we recommend the use of the DLQI in teledermatology, including the use of the DLQI app which is available in seven languages; it is important to develop apps for dermatology-specific HRQoL instruments for use in children (for example the CDLQI and InToDermQoL) and for disease-specific instruments.

Quality of life in patients with early- and late-onset hidradenitis suppurativa.

Hidradenitis suppurativa (HS) usually has an early onset, however, also onset in the mid-40 s may occur. Recently, the threshold of 28 years to distinguish patients with early and late onset has been proposed. The objective of our study was to compare the quality of life (QoL) and psychological distress in early- and late-onset HS patients. In this cross-sectional, observational study, consecutive patients diagnosed with HS aged ≥ 16 years were recruited. Dermatology-specific QoL was evaluated using the Skindex-17 questionnaire, and psychological distress using the 12-item General Health Questionnaire (GHQ-12). Patients were categorized into "early onset" (< 28 years) and "late onset" (≥ 28 years). Data were collected on 467 patients. Mean age at diagnosis was 21.6 years, with 22.0% of patients presenting with late disease onset. Patients with late onset reported worse psychosocial QoL and higher psychological distress compared to early onset. No differences between the two groups were observed for clinical severity. In the final multivariate model lower diagnostic delay, higher number of fistulae, higher BMI, ex-smoker, no localization on axillae, no localization on mammary region, presence of psoriasis, and higher scores on the psychosocial scale of Skindex-17 were statistically significantly associated with late onset. In conclusion, the psychosocial impact of HS is higher in patients with late onset compared to those with early onset. Differences between these two groups should be further investigated.

Quality of life assessment in core outcome sets: A position statement of the EADV Task Force on Quality of Life and Patient Oriented Outcomes.

Core outcome sets (COSs) are an agreed standardized collection of outcomes that should be measured and reported in all clinical trials for a specific clinical condition. Tsekhe aim of our position paper by the European Academy of Dermatology and Venereology (EADV) Task Force on Quality of Life and Patient Oriented Outcomes was to identify the challenges and Patient Oriented Outcomes advantages in the development of COSs within dermatological QoL research. Twelve EADV Task Force multidisciplinary team members presented a total of 101 items (51 advantages and 50 disadvantages). All participants considered that COS are beneficial for comparison between different studies, treatments, dermatological diseases, geographical location and ethnicities. In conclusion, the EADV Task Force on Quality of Life and Patient Oriented Outcomes has recognized the primacy of advantages of COS and deliberated that the disadvantages in COS are related to development process and use of COS.

Characteristics of children and adolescents with atopic dermatitis who attended therapeutic patient education.

BACKGROUND: Atopic dermatitis (AD) is a chronic, relapsing, inflammatory skin disease. Therapeutic patient education (TPE) has been demonstrated to be effective in AD in reducing disease severity and improving coping and quality of life. OBJECTIVES: To describe the sociodemographic and clinical characteristics of children and adolescents with AD who had attended TPE sessions, as well as the characteristics of their parents, and compare them with those who did not attend TPE. METHODS: Parents of children with AD aged 6-17 years old were recruited from a representative sample of the French population contacted by e-mail. Sociodemographic data and clinical information were collected in patients and parents. Clinical severity was assessed by parents using a proxy version of the Patient-Oriented Eczema Measure (POEM). Attendance to TPE sessions was assessed by the following question 'did your child or one or both parents attended TPE for AD?'. Also, the number of sessions was recorded. Determinants of TPE attendance were evaluated by univariable and multivariable analyses. RESULTS: Data were collected on 1063 parents and children with AD. A total of 131 (12.3%) children and/or parents attended TPE sessions. Most of them attended 2-5 TPE sessions. In that group, there were 85 boys (64.9%), and severity evaluated by POEM was mild in 29.8%, moderate in 52.7% and severe in 17.6% of patients. In the multivariable model, attending TPE sessions was significantly associated with sex of the child (boy vs. girl), consultation with a dermatologist or a paediatrician, high clinical severity and presence of AD in parents. CONCLUSIONS: Despite recommendations, the use of TPE in children with AD is still low in France. There is a need for implementing such programmes in the management of the disease, in particular when the disease is severe.

Quality of life measurement in alopecia areata. Position statement of the European Academy of Dermatology and Venereology Task Force on Quality of Life and Patient Oriented Outcomes.

New treatment options may lead to an increased interest in using reliable and sensitive instruments to assess health-related quality of life in people with alopecia areata (AA). The purpose of this paper is to present current knowledge about quality of life assessment in AA. The dermatology-specific Dermatology Life Quality Index (DLQI) was the most widely reported health-related quality of life instrument used in AA. Three AA-specific (Alopecia Areata Symptom Impact Scale, Alopecia Areata Quality of Life Index and Alopecia Areata Patients' Quality of Life) and three hair disease-specific instruments (Hairdex, Scalpdex and 'hair-specific Skindex-29') were identified with a range of content and validation characteristics: there is little evidence yet of the actual use of these measures in AA. Scalpdex is the best-validated hair disease-specific instrument. Further extensive validation is needed for all of the AA-specific instruments. The European Academy of Dermatology and Venereology Task Force on Quality of Life and Patient Oriented Outcomes recommends the use of the dermatology-specific DLQI questionnaire, hair disease-specific Scalpdex and the alopecia areata-specific instruments the Alopecia Areata Symptom Impact Scale or Alopecia Areata Quality of Life Index, despite the limited experience of their use. We hope that new treatment methods will be able to improve both clinical signs and health-related quality of life in patients with AA. In order to assess the outcomes of trials on these new treatment methods, it would be helpful when further development and validation of AA-specific instruments is being encouraged and also conducted.

Methods to improve quality of life, beyond medicines. Position statement of the European Academy of Dermatology and Venereology Task Force on Quality of Life and Patient Oriented Outcomes.

The pharmaceutical approach to skin disease has been hugely successful, but despite effective drugs being available and used, there are still vast numbers of people who continue to have some level of persisting skin disease and continue to experience quality of life (QoL) impairment. So the question that needs to be answered, while we await further advances in our drug-based armamentarium, is how can we improve patients' QoL, beyond drugs? A working group was formed from members of the EADV Task Force on QoL and Patient Oriented Outcomes. Participants were asked to suggest all the ways in which they considered patients' QoL may be improved beyond medicines. Four groups of management approaches that may improve QoL in dermatology were identified: interventions within the dermatology service (hospitalization, multidisciplinary teams, patch testing and establishing relevant allergens and education), external services (corrective make-up, climatotherapy and balneotherapy), psychological (psychological intervention, cognitive therapy, hypnosis), lifestyle (lifestyle behavioural changes, religion and spirituality and music). The ultimate aim of therapy is to eradicate a disease in an individual and return the person's life to normal. But until the day comes when this has been achieved for every skin disease and for every patient there will be a need to support and assist many patients in additional non-pharmaceutical ways. These 'adjuvant' approaches receive too little attention while dermatologists and researchers strive for better pharmacological therapy. The different ways in which patients may benefit have been reviewed in our paper, but the reality is that most have a very poor evidence base. The research challenges that we have to meet are to identify those approaches that might be of value and to provide evidence for their optimal use. In the meantime, clinicians should consider the use of these approaches where QoL remains impaired despite optimal use of standard therapy.

Position statement of the European Academy of Dermatology and Venereology Task Force on Quality of Life and Patient Oriented Outcomes on quality of life issues in dermatologic patients during the COVID-19 pandemic.

The pandemic of COVID-19 is a global challenge for health care, and dermatologists are not standing apart from trying to meet this challenge. The European Academy of Dermatology and Venereology (EADV) has collected recommendations from its Task Forces (TFs) related to COVID-19. The Journal of the EADV has established a COVID-19 Special Forum giving free access to related articles. The psychosocial effects of the pandemic, an increase in contact dermatitis and several other skin diseases because of stress, disinfectants and protective equipment use, especially in healthcare workers, the temporary limited access to dermatologic care, the dilemma whether or not to pause immunosuppressive therapy, and, finally, the occurrence of skin lesions in patients infected by COVID-19 all contribute to significant quality of life (QoL) impairment. Here, we present detailed recommendations of the EADV TF on QoL and patient-oriented outcomes on how to improve QoL in dermatologic patients during the COVID-19 pandemic for several different groups of patients and for the general population.

Sex- and gender-associated clinical and psychosocial characteristics of patients with psoriasis.

BACKGROUND: Sex and gender may affect disease prevalence, adverse effects and response to therapy. AIM: To analyse sex and gender differences in outpatients with psoriasis. METHODS: A cross-sectional study was conducted at IDI-IRCCS, Rome, over a 3-year period. In total, 3023 patients with psoriasis were enrolled. Anthropometric and demographic characteristics were recorded, and a dermatologist evaluated the clinical severity of disease. Quality of life (QoL) questionnaires were collected. Univariate and multivariate analyses were performed to examine factors associated with sex. RESULTS: We found sex- and gender-associated differences in clinical characteristics, disease severity, psychological distress and quality of life. Male sex was associated with body mass index, smoking, alcohol consumption, Psoriasis Area Severity Index ≥ 10 and age at onset ≥ 20 years. Female sex was associated with family history of diabetes, joint involvement, clinical type other than diffuse plaque psoriasis, higher psychological distress and a greater effect on QoL. CONCLUSION: Our study identified sex and gender differences of potential clinical relevance in psoriasis.

'The psychosocial burden of alopecia areata and androgenetica': a cross-sectional multicentre study among dermatological out-patients in 13 European countries.

BACKGROUND: Hair diseases play an important burden on patients' lives, causing significant emotional and psychosocial distress. However, the impairment due to different hair conditions, such as alopecia areata (AA) and androgenetic alopecia (AGA), has rarely been compared. OBJECTIVE: The aim of this study was to assess the psychological burden of subgroups of patients with different hair diseases and to compare them to a healthy population. METHODS: In this study, we analysed a subgroup of patients with hair diseases from patients of a large multicentre study including 3635 dermatological patients and 1359 controls from 13 European countries. In the subgroup of patients with hair diseases, we analysed the socio-demographic characteristics, the stress level, and the impact of hair diseases on quality of life (QoL), anxiety, and depression and we compared them among patients with AA, AGA and healthy controls. RESULTS: The study population included 115 patients (77% women, 23% men) with hair diseases, 37 of whom with AA and 20 with AGA. Patients with hair diseases had a lower education level than healthy controls (medium educational level: 43% vs. 28%). Overall, 41% of the patients reported stressful life events during the last 6 months compared with 31% of the controls. Patients with the same age, sex, depression level and comorbidities had a worse QoL when suffering from AA than from AGA (Mean Dermatology Life Quality Index score: 5.8 vs. 2.5). CONCLUSION: Patients with hair diseases are more anxious, depressed and have a lower QoL than controls.

Quality of life measurement in hidradenitis suppurativa: position statement of the European Academy of Dermatology and Venereology task forces on Quality of Life and Patient-Oriented Outcomes and Acne, Rosacea and Hidradenitis Suppurativa.

This paper is organized jointly by the European Academy of Dermatology and Venereology (EADV) Task Force (TF) on Quality of Life (QoL) and Patient-Oriented Outcomes and the EADV TF on acne, rosacea and hidradenitis suppurativa (ARHS). The purpose of this paper was to present current knowledge about QoL assessment in HS, including data on HS-specific health-related (HR) QoL instruments and HRQoL changes in clinical trials, and to make practical recommendations concerning the assessment of QoL in people with HS. HS results in significant quimp that is higher than in most other chronic skin diseases. HS impact in published studies was assessed predominantly (84% of studies) by the Dermatology Life Quality Index (DLQI). There is a lack of high-quality clinical trials in HS patients where HRQoL instruments have been used as outcome measures. One double-blind randomized placebo-controlled trial on infliximab with low number of participants reported significantly better HRQoL improvement in the treatment group than in the placebo group. Well-designed clinical studies in HS patients to compare different treatment methods, including surgical methods and assessing long-term effects, are needed. Because of lack of sufficient validation, the Task Forces are not at present able to recommend existing HS-specific HRQoL instruments for use in clinical studies. The EADV TFs recommend the dermatology-specific DLQI questionnaire for use in HS patients. The EADV TFs encourage the further development, validation and use of other HS-specific, dermatology-specific and generic instruments but such use should be based on the principles presented in the previous publications of the EADV TF on QoL and Patient-Oriented Outcomes.

Quality of life measurement in skin cancer patients: literature review and position paper of the European Academy of Dermatology and Venereology Task Forces on Quality of Life and Patient Oriented Outcomes, Melanoma and Non-Melanoma Skin Cancer.

The European Academy of Dermatology and Venereology (EADV) Task Forces (TFs) on Quality of Life (QoL) and Patient Oriented Outcomes, Melanoma and Non-Melanoma Skin Cancer (NMSC) present a review of the literature and position statement on health-related (HR) QoL assessment in skin cancer patients. A literature search was carried out to identify publications since 1980 that included information about the impact of SC on QoL. Generic, dermatology-specific, cancer-specific, SC-specific, facial SC-specific, NMSC-specific, basal cell carcinoma-specific and melanoma-specific QoL questionnaires have been used to assess HRQoL in SC patients. HRQoL was assessed in the context of creation and validation of the HRQoL instruments, clinical trials, comparison of QoL in SC and other cancers, other diseases or controls, HRQoL assessment after treatment, comorbidities, behaviour modification, predictors of QoL and survival, supportive care needs, coping strategies and fear of cancer recurrence. The most widely used instruments for HRQoL assessment in SC patients are the European Organisation for Research and Treatment of Cancer Core Questionnaire (EORTC QLQ-C30), the Functional Assessment of Cancer Therapy-Melanoma (FACT-M), Skin Cancer Index (SCI), Short Form 36 Item Health Survey (SF-36) and the Dermatology Life Quality Index (DLQI). The TFs recommend the use of the cancer-specific EORTC QLQ-C30, especially in late stages of disease, and the melanoma-specific FACT-M and SC-specific SCI questionnaires. These instruments have been well validated and used in several studies. Other HRQoL instruments, also with good basic validation, are not currently recommended because the experience of their use is too limited. Dermatology-specific HRQoL instruments can be used to assess the impact of skin-related problems in SC. The TFs encourage further studies to validate HRQoL instruments for use in different stages of SC, in order to allow more detailed practical recommendations on HRQoL assessment in SC.

Validation of the dermatology-specific proxy instrument the Infants and Toddlers Dermatology Quality of Life.

BACKGROUND: The first dermatology-specific proxy health-related quality of life (HRQoL) instrument for children 0-4 years old with skin diseases, the Infants and Toddlers Dermatology Quality of Life (InToDermQoL), was recently developed. In order to avoid the problem of cross-cultural inequivalence focus groups work and pilot tests were organized simultaneously in all national centres of the project. The InToDermQoL showed good comprehensibility, clarity and acceptance. OBJECTIVE: To validate the InToDermQoL questionnaire during international field tests. METHODS: Internal consistency, test-retest reliability, convergent and discriminant validity of the InToDermQoL questionnaire were checked during international field tests. RESULTS: Parents of 473 children with skin diseases filled in the national language versions of the InToDermQoL questionnaire. All three age-specific versions of the InToDermQoL questionnaire with 10, 12 and 15 items, respectively, showed high internal consistency (Cronbach's α 0.90-0.93), good test-retest reliability (correlation coefficients > 0.9), significant correlations with the most widely used atopic dermatitis-specific proxy instrument, the Infants Dermatitis Quality of Life Index (correlation coefficients 0.68-0.79). The InToDermQoL versions for children <3 years old well correlated with the atopic dermatis severity measure Scoring of Atopic Dermatitis (correlation coefficients 0.66 and 0.86 for 10 and 12 items versions, respectively). The InToDermQoL questionnaire discriminated well among different diagnoses and disease severity levels. CONCLUSION: Our field tests confirmed internal consistency, test-retest reliability, convergent and discriminant validity of the InToDermQoL questionnaire. Development and validation of the InToDermQoL questionnaire make it possible to assess dermatology-specific aspects of HRQoL in youngest children with skin diseases. There are many reasons to assess HRQoL in dermatologic clinical practice, and we hope that our new instrument will be used internationally in paediatric dermatology for research and practical needs.