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 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.

Pruritus Intensity Scales across Europe: a prospective validation study.

BACKGROUND: Chronic pruritus (CP) is a subjective symptom, and it is necessary to assess its intensity with validated patient-reported outcome tools in order to allow determination of the treatment course. OBJECTIVES: So far, the itch intensity scales were validated in small cohorts and in single languages. Here, we report the validation of the numerical rating scale, the verbal rating scale and the visual analogue scale for the worst and average pruritus intensity in the last 24h in several languages across Europe and across different pruritic dermatoses. METHODS: After professional translation, the intensity scales were digitized for use as a tablet computer application. Validation was performed in clinics for Dermatology in Austria, France, Germany, Italy, Poland, Russia, Spain, Switzerland and Turkey. RESULTS: A total of 547 patients with contact dermatitis, chronic nodular prurigo, psoriasis vulgaris, lichen planus or cutaneous T-cell lymphoma were included. The intensity scales showed a high level of reproducibility and inter-correlations with each other. The correlation with the Dermatology Life Quality Index was weak to strong in nearly all countries and dermatoses with the exception of France and patients with chronic nodular prurigo, for which no statistically significant correlations were found. CONCLUSIONS: The numerical rating scale, the verbal rating scale und the visual analogue scales are valid instruments with good reproducibility and internal consistency in German (Germany, Austria, Switzerland), French, Italian, Polish, Russian, Spanish and Turkish for different pruritic dermatoses. VAS worst was the best reproducible and consistent measuring instrument in all countries.

Characterizing treatment-related patient needs in atopic eczema: insights for personalized goal orientation.

BACKGROUND: Atopic eczema (AE) is a common and burdensome chronic skin disease. Clinical guidelines suggest an evidence-based, personalized and stepwise treatment approach. Only few studies have so far focused on the specific patient needs in treatment. OBJECTIVES: To characterize therapeutic needs of patients with AE in routine care. METHODS: Nationwide cross-sectional study in 91 dermatology practices and outpatient clinics. Descriptive statistics were used for valuation. Comparisons of HRQoL and general health status were performed including subgroups (age, gender and disease duration). Group comparisons of patient needs were performed for age groups, gender and disease duration. Correlations between patients' needs (PNQ) and HRQoL, generic health status and severity were tested. In addition, a hierarchical regression analysis was performed to determine which variables contribute to explain the variance in patient needs. RESULTS: Analysis of 1678 patients (60.5% female, mean age 38.35 ± 15.92 years) revealed a high disease burden with mean SCORAD of 42.26 ± 18.63, mean DLQI of 8.49 ± 6.45 and mean EQ VAS of 63.62 ± 21.98. Among the patient needs that were most frequently rated as 'quite important'/'very important' were as follows: 'to be free of itching' (96.0%), 'to get better skin quickly' (87.7%) and 'to be healed of all skin defects' (85.7%). In general, older people, women and patients who had been diagnosed with AE for 1 year or less rated the treatment needs as more important than younger patients, men and patients who had been diagnosed with AE for more than 1 year. Major determinants of higher needs were skin-related quality of life impairments, higher disease severity and higher age. CONCLUSIONS: Patients with AE show a high number and variety of therapeutic needs related to disease signs and symptoms, which are associated with individual disease burden. The patient needs vary substantially according to patient characteristics. Identification of patient-specific needs may support personalized, patient-centred care and shared decision-making.

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.

Gender and age significantly determine patient needs and treatment goals in psoriasis - a lesson for practice.

BACKGROUND: Though patient needs are key drivers of treatment decisions, they are rarely systematically investigated in routine care. OBJECTIVE: This study aimed at analysing needs and expectations from the patient perspective in the German and Swiss psoriasis registries PsoBest and Swiss Dermatology Network of Targeted Therapies (SDNTT) with respect to treatment choice, age and gender. METHODS: The German and Swiss psoriasis registries observe patients recruited at first-time use of systemic drugs. Within 10 years, clinical [Psoriasis Area Severity Index (PASI), Body Surface Area (BSA)] and patient-reported outcomes are documented, including the Dermatology Quality of Life Index (DLQI) and the Patient Benefit Index (PBI), characterizing patient needs for treatment. The analysis data set includes n = 4894 patients from PsoBest and n = 449 from SDNTT with mean follow-up time of 7.5 months. RESULTS: A total of 5343 patients registered between 2008 and 2016 were included in the analyses (at baseline: 59.6% male, mean age 47.6 years ± 14.5, PASI 14.2 ± 9.7, BSA 22.7 ± 19.7, DLQI 11.3 ± 7.2). The most important patient needs were to 'get better skin quickly' and to 'be healed of all skin defects'. Subgroup analyses by age revealed significant differences in needs, especially higher needs regarding social impairments in patients younger than 65 years. Patients 65 years or older attributed more importance to sleep quality, less dependency on medical visits, fewer side-effects and confidence in the therapy. Out of 25 items reflecting patient needs, 20 items were rated significantly more important by women than men, with the greatest differences regarding feeling of depression, sleep quality and everyday productivity. Divided by treatment, needs were rated differently, recommending individualized and targeted choice of therapy. CONCLUSION: Age and gender stratify patient needs. Women showed higher expectations and rated specific needs in psoriasis treatment higher than men. Analysing the patient needs on an individual level will facilitate shared decisions by patient and physician in finding the optimal personalized treatment.

Cross-European validation of the ItchyQoL in pruritic dermatoses.

BACKGROUND: Chronic pruritus (CP) is a frequently occurring symptom in inflammatory dermatoses, causing a high burden and limitations to health-related quality of life (HRQoL). OBJECTIVE: The ItchyQoL was developed to assess the impairment to HRQoL in patients with CP. However, it has only been validated in English and German. Here, we report the validation in several languages across Europe. METHODS: After professional translation, the versions of ItchyQoL were digitized for use as a tablet application. Validation was performed in clinics for dermatology in Austria, France, Germany, Italy, Poland, Russia, Spain, Switzerland and Turkey. RESULTS: Five hundred and thirty-five patients with either contact dermatitis, chronic prurigo - nodular type, psoriasis vulgaris, lichen planus or mycosis fungoides/Sézary syndrome and with CP ≥ 3 on the numerical rating scale were included. ItchyQoL showed a high level of consistency (Cronbach's-α, all: 0.95) and test-retest reliability (intraclass correlation: 0.91). It strongly correlated with the Dermatology Life Quality Index (r = 0.72, P < 0.001) and moderately correlated with itch intensity scales in the study population (visual analogue scale r = 0.46; numerical rating scale r = 0.51; verbal rating scale r = 0.51, for all: P < 0.001). CONCLUSION: ItchyQoL is now also validated in French, Italian, Polish, Russian, Spanish and Turkish and can be used in clinical trials in countries speaking these languages.

Validation of a short-form of the Freiburg Life Quality Assessment for lymphoedema (FLQA-LS) instrument.

BACKGROUND: Chronic lymphoedema (CLE) is a burdensome disease of multiple causes leading to significant reductions in health-related quality of life (HRQoL). A specific method to assess HRQoL is the Freiburg Life Quality Assessment for lymphoedema (FLQA-L), which consists of 92 items. OBJECTIVES: To develop and validate a short form of the FLQA-L with improved psychometric properties and feasibility. METHODS: The FLQA-L validation data were reanalysed by patients and experts. The application of factor analysis enabled the exclusion of lower-load items. An optimized short version of the questionnaire (FLQA-LS) with 33 items was generated and tested in a validation study on patients with different forms of CLE. RESULTS: In total, 348 patients with CLE of the upper or lower extremities were included (mean age 57.3 years, range 24-89; 90.8% female), and data from 301 patients could be analysed. Overall, 42.8% of the patients had secondary lymphoedema, 23.6% had primary lymphoedema, 9.5% had lipoedema and 24.1% had lipolymphoedema. The lower extremities were mostly affected (64.4% of the patients presented with leg involvement and 17.5% with both arm and leg impairment). The FLQA-LS showed good internal consistency, with high Cronbach's alpha in the subscales and in the global scale ranging between 0.79 and 0.94. Regarding convergent validity, a good correlation was found with the general HRQoL questionnaire EQ-5D (r = 0.72, P < 0.001). CONCLUSIONS: FLQA-LS is an improved version of the FLQA-L questionnaire for chronic lymphoedema. It demonstrated validity and feasibility and can be easily used in clinical practice and research studies.

Chronic pruritus: evaluation of patient needs and treatment goals with a special regard to differences according to pruritus classification and sex.

BACKGROUND: Chronic pruritus (CP) is present in approximately one-third of all dermatological patients. Diagnostics and treatment are challenging and impair patients' quality of life. OBJECTIVES: To analyse therapeutic needs in terms of the importance of treatment goals in a large sample of patients with CP. METHODS: Routine data of 2747 patients with CP were analysed with descriptive methods and significance tests (univariate and multivariate variance analyses). The importance of 27 need items was measured using the Patient Needs Questionnaire of the Patient Benefit Index. RESULTS: The most important needs were to find a clear diagnosis and treatment, to no longer experience itching and to have confidence in the therapy, which were quite or very important to > 90% of the patients. The least important goals concerned a normal working or sex life. Nine needs related mostly to disease and psychological symptoms, and some social needs differed in importance between sexes (P ≤ 0·05). Patients with pruritus on inflamed skin or with chronic scratch lesions judged more than half of all needs as more important than did patients with pruritus on noninflamed skin (P ≤ 0·05). In the multivariate model, age, pruritus intensity and quality of life had a significant effect on the importance of therapeutic needs besides sex and pruritus classification. CONCLUSIONS: Patients with CP present high levels of various therapeutic needs with differences by sex and clinical phenotype. The most important needs can be addressed through medical activities such as appropriate itch medication and a trustful doctor-patient relationship.

Cost-of-illness of patients with lymphoedema.

BACKGROUND: Chronic lymphoedema is characterized by a continuous need for medical treatment, many comorbidities and impaired quality of life. In Germany, about 4.5 million patients are affected by lymphoedema. Thus, lymphoedema causes high direct and indirect costs, even more in case of complications such as erysipelas and ulcers. OBJECTIVE: The aim of this study was to determine the costs of illness of community lymphoedema patients living in the metropolitan area of Hamburg, Germany. METHODS: An observational cross-sectional study in patients with lymphoedema and combined lipolymphoedema of any origin was performed analysing direct and indirect costs for the patients, the statutory health insurance and society. RESULTS: In total, 348 patients (90.8% female) were examined and interviewed. The mean age of the patients was 57.3 ± 14.5 years. On average, the total costs per patient and year were € 5784, of which € 4445 (76.9%) were direct costs and € 1338 indirect costs. Within the direct medical costs, € 3796 were accounted for the statutory health insurances and € 649 for the patient. The main cost drivers were costs for manual decongestive therapy and disability costs. CONCLUSION: Chronic lymphoedema is associated with high direct and indirect costs. This community-based study is the first cost analysis of chronic lymphoedema and combined lipolymphoedema giving insights to economic impact of lymphoedema treatment. There is a high need for structured disease management programs in order to diagnose and treat lymphoedema early and to avoid complications, thus limiting socio-economic burden.

Novel TRPM8 agonist cooling compound against chronic itch: results from a randomized, double-blind, controlled, pilot study in dry skin.

BACKGROUND: Patients suffering from chronic pruritus (CP) due to dry skin with are often applying emollients containing menthol. However, topical menthol may be irritating and of weak potency in severe pruritus. Two TRPM8 agonists, (1R,2S,5R)-N-(2-(2-pyridinyl)ethyl)-2-ispropyl-5-methylcyclohexancarboxamide and menthoxypropanediol, combined as cooling compound (CC) have shown stronger activation of TRPM8 than menthol. OBJECTIVES: Objective of this study was to evaluate the efficacy and safety of CC in alleviating pruritus in patients with dry itchy skin. METHODS: In this vehicle-controlled, double-blind, randomized (1 : 1) study, 70 dry skin patients with pruritus intensity measured by Numerical Rating Scale (NRS) ≥3, were treated twice daily over 4 weeks, either with a lotion containing CC or with its vehicle. RESULTS: At treatment end, pruritus, assessed by a global score, improved significantly more in the CC than in the vehicle group (79.2% vs. 47.1%; P < 0.05; primary endpoint). Also assessed by verbal rating scale (VRS) and percentual improvement, pruritus decreased significantly more in the CC group (P = 0.007/P = 0.015) compared to vehicle arm after treatment. Up to 84% of CC-treated patients reported a significant, sometimes too strong, long-lasting cooling effect. The health-related quality of life improved significantly more in the CC group (P = 0.023). Skin roughness, dryness and hydration improved significantly in both groups without significant differences in-between them. There were no severe adverse events reported. CONCLUSIONS: Treatment of dry and pruritic skin with a lotion containing the TRPM8 agonist combination ameliorates severe pruritus and represents a possible novel treatment for the burdensome symptom. The most suitable treatment concentration needs still to be identified. ClinicalTrials.gov: NCT00669708.

Quality of life and patient benefit following transition from methotrexate to ustekinumab in psoriasis.

BACKGROUND: TRANSIT (NCT01059773) compared immediate and gradual transition from methotrexate to ustekinumab in psoriasis patients via multiple measures, including patient-reported outcomes. OBJECTIVE: To evaluate patient perception of treatment benefits in TRANSIT. METHODS: A total of 489 psoriasis patients received ustekinumab, with immediate cessation of methotrexate (Arm 1) or 4 weeks' overlap with decreasing methotrexate dose (Arm 2). Ustekinumab was administered at weeks 0, 4, 16, 28 and 40. Dermatology Life Quality Index (DLQI), EuroQol 5-item (EQ-5D), visual analogue scale (VAS) valuation technique and patient benefit index (PBI) were employed. Mean global PBI and sub-scores were calculated from the sum of the benefit items weighted by their respective relevance at baseline. Patient-relevant benefit was defined as PBI ≥1 (scale: 0 [no benefit] to 4 [maximum benefit]). Correlations of global PBI with Psoriasis Area and Severity Index (PASI) and DLQI were examined. RESULTS: Relationships between PBI and clinical data were evaluable in 340 patients. The most important treatment goals at baseline included: 'be healed of all skin defects', 'have confidence in therapy', 'get better skin quickly' and 'regain control of the disease'. Benefit in PBI global score was achieved at week 4 by 93% of patients in Arm 1 and 91% in Arm 2. Global PBI scores increased in both Arms between weeks 4 and 52. Global PBI correlated weakly with PASI change from baseline (correlation coefficient range: -0.22 to -0.40), and moderately with DLQI (-0.29 to -0.54). Overall DLQI score was lower than baseline at all times; and the percentage of patients with an overall score of 0 or 1 increased with time. Correspondingly, EQ VAS scores increased with time. DLQI and EQ VAS results were similar between arms. CONCLUSIONS: Regardless of the strategy for transitioning from methotrexate, ustekinumab was associated with rapid and sustained improvement in patient-reported outcomes. PBI appears a suitable tool for assessing patient-relevant treatment benefits in psoriasis patients.

Patient-relevant needs and treatment goals in nail psoriasis.

PURPOSE: Patient-centered health care implies that medical decisions are made jointly by physician and patient, based on patient needs. Aims were to (a) identify treatment goals for a new questionnaire on patient needs and benefits in nail psoriasis treatment; (b) analyze the importance of treatment goals in patients with nail psoriasis in general and in defined subgroups; and (c) determine the association between overall treatment goal importance and quality of life. METHODS: The study comprised the following steps: qualitative survey on needs and burdens in 120 patients; development of items by an interdisciplinary expert group; item testing in 55 patients in four countries; revision of the questionnaire and assessment in 203 patients in six countries (Germany, Denmark, Italy, Spain, USA, Japan). The percentage of patients rating the goals as 'quite/very important' was compared between various patient subgroups. RESULTS: Based on 692 free-text statements, 26 items were developed which were reduced to 24 items after pilot testing. Each of these treatment goals applied to the majority of patients in the multi-center study. Goal importance increased with severity of nail psoriasis, but not with age or disease duration. Manual dexterity and social interaction were of particular importance. Goal importance and quality of life were associated, but not redundant (r = 0.612, p < 0.001). CONCLUSIONS: Patients with nail psoriasis have manifold and specific treatment goals. Goal importance is a construct different from disease-specific quality of life and should be assessed separately. The new questionnaire can support goal setting in clinical practice.

Differences in patient and physician assessment of a dynamic patient reported outcome tool for chronic pruritus.

BACKGROUND: Chronic pruritus is a subjective symptom, mainly measured through patient reported outcomes. Our aim is to assess two different methods regarding the change of symptoms: a visual dynamic pruritus score (vDPS) documented by patients, and a numerical value (nDPS) documented by physicians. METHODS: Inferential statistics and reliability analyses have been performed on data collected in 2013. RESULTS: Data of 701 patients were analysed (45.6% males, 54.4% females, mean age 60 ± 16 years). The nDPS showed less extreme and generally lower values than the vDPS. There was a slight concordance between both methods; the highest concordance was seen for no/weak change and very good reduction. CONCLUSION: The difference between patient and physician assessed same score points to an important bias in pruritus assessment which has to be taken into account especially in clinical trials. Though further studies are needed, the patient-based assessment seems to be less biased by a social desirability effect.

European EADV network on assessment of severity and burden of Pruritus (PruNet): first meeting on outcome tools.

BACKGROUND: Chronic pruritus is a frequently occurring symptom of various dermatoses that causes a high burden and impaired quality of life. An effective anti pruritic therapy is important for the patient, but its effectiveness is difficult to evaluate. Diverse methods and interpretations of pruritic metrics are utilized in clinical trials and the daily clinical practice in different countries, resulting in difficulties comparing collected data. METHODS: We founded a European Network on Assessment of Severity and Burden of Pruritus (PruNet) that is supported by the EADV. PruNet consists of 28 experts from 15 EU countries (21 dermatologists, 5 medical informaticists, 2 psychologists) and aims to unify the assessment of itch in routine dermatological care. Following a preliminary survey, a consensus conference was held in order to agree upon the prioritization of patient-reported outcome tools. RESULTS: Through utilizing the Delphi method, it was agreed that tools for measuring itch intensity (ex. the visual analogue scale) and quality of life (ex. ItchyQoL) are of primary importance and should urgently be foremost validated. CONCLUSION: The validation and harmonization of standards are needed for the improvement of quality care for patients suffering from pruritic dermatoses. This summer, the first validation studies in several EADV member countries already began.

[Quality of life in dermatology. From measurement to practical implementation]. / Lebensqualität in der Dermatologie. Von der Messung zur praktischen Umsetzung.

Health-related quality of life has not only been established as an important patient-reported outcome measure in patient care but has been defined as an evaluation criterion for therapies in the German Code of Social Law as well as in the guidelines of the American Food and Drug Administration and of the European Medicines Agency (EMA). Quality of life can be measured in a standardised manner. Validated questionnaires are available for recording specific problems of patients with, for example, skin diseases. Measuring quality of life has not yet been implemented into daily dermatological routine, although (1) studies have confirmed that the measurement of quality of life offers major benefits for the treatment of skin diseases, and (2) first experiences in implementing quality of life measurement into practice have been positive. The further implementation of systemically measuring quality of life requires advancements in automated measurement and the assumption of cost by social health insurances.

[Health-related quality of life: a pivotal endpoint in benefit assessment of medical procedures]. / Gesundheitsbezogene Lebensqualität - ein zentraler patientenrelevanter Endpunkt in der Nutzenbewertung medizinischer Maßnahmen.

BACKGROUND: According to German law, health-related quality of life is a relevant criterion in the early assessment of the benefits of drug treatment. In spite of its regulatory importance, the role of quality of life assessment in quantifying the additional benefits of novel vs standard treatments is not yet clear. OBJECTIVES: The paper is aimed at analyzing the theoretical foundation, the methodological foundation, and the empirical evaluation of the criterion "quality of life" in recent benefit dossiers, as published by the Federal Joint Committee (G-BA) and the German Institute for Quality and Efficiency in Health Care (IQWiG). MATERIALS AND METHODS: Benefit dossiers assessed by the end of 2013 were quantitatively analyzed regarding the choice, frequency of use, and consequences of quality of life assessment. RESULTS: In 59 of the 66 dossiers quality of life assessment was performed, frequently using the EQ-5D (n = 16 procedures) and the SF-36 (n = 8 procedures). Of the 107 evaluations of the subpopulation within these 59 dossiers, in only 2 cases was an additional benefit due to the quality of life declared by the IQWiG and G-BA. CONCLUSIONS: In spite of the acceptance of quality of life measures and their inclusion in the dossiers, they have rarely been the basis for the declaration of additional benefits. This reluctance does not stem from the availability of instruments, but results from problems in their selection, the design and conduct of the study, data interpretation, together with shortcomings regarding the statistical and clinical significance of quality of life data.