Search

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Background The assessment of patient-relevant benefit is gaining importance in evaluating treatments. The ‘Patient Benefit Index, standard version’ questionnaire (PBI-S) is a validated instrument to assess patients’ treatment needs and benefits in skin diseases. Before therapy, the patient rates the importance of predefined treatment goals; after therapy, he rates the extent to which these goals have been achieved. Thus far, no such instrument has been developed specifically for pruritus. Objectives Development and validation of a patient-relevant benefit questionnaire in the treatment of pruritus. Methods Fifty patients with pruritus were questioned on impairments due to pruritus and treatment needs. Four treatment objectives not already covered by the PBI-S were added to obtain a disease-specific instrument. This was tested for feasibility by 36 patients with pruritus and validated in a sample of 100 patients with pruritus. Results The instrument was feasible in clinical practice. There were < 2% missing values. Cronbach’s alpha of the needs questionnaire was 0·93. Convergent validity was demonstrated with respect to reduction of pruritus and quality of life. Conclusions The PBI for pruritus is a feasible, reliable and valid instrument that is highly accepted in daily routine for recording patient-reported benefit. [ABSTRACT FROM AUTHOR]