Christine Blome

Assessment of pruritus intensity: prospective study on validity and reliability of the visual analogue scale, numerical rating scale and verbal rating scale in 471 patients with chronic pruritus.

The most commonly used tool for self-report of pruritus intensity is the visual analogue scale (VAS). Similar tools are the numerical rating scale (NRS) and verbal rating scale (VRS). In the present study, initiated by the International Forum for the Study of Itch assessing reliability of these tools, 471 randomly selected patients with chronic itch (200 males, 271 females, mean age 58.44 years) recorded their pruritus intensity on VAS (100-mm line), NRS (0-10) and VRS (four-point) scales. Re-test reliability was analysed in a subgroup of 250 patients after one hour. Statistical analysis showed a high reliability and concurrent validity (r>0.8; p<0.01) for all tools. Mean values of all scales showed a high correlation. In conclusion, high reliability and concurrent validity was found for VAS, NRS and VRS. On re-test, higher correlation and less missing values were observed. A training session before starting a clinical trial is recommended.

Prevalence and clinical features of psoriatic arthritis and joint complaints in 2009 patients with psoriasis: results of a German national survey

Background  Psoriatic arthritis (PsA) is a chronic, systemic, inflammatory disorder characterized by the association of arthritis with psoriasis. Patients with PsA may have a heterogeneous and variable clinical course. Evidence that affected patients can have significant radiographic joint damage, functional impairment, reduced quality of life and long‐term work disability is increasing.

Visual analogue scale: evaluation of the instrument for the assessment of pruritus.

The aim of this study was to evaluate the visual analogue scale (VAS) as a method of pruritus assessment. A total of 310 subjects with pruritic dermatoses (148 Caucasian subjects and 162 Asian subjects) were recruited. The patients assessed pruritus intensity using the horizontal and vertical VAS, numeric rating scale (NRS) and verbal rating scale (VRS). All scales showed very good reproducibility (intraclass coefficient (ICC) > 0.8). No significant differences were found between the horizontal and vertical VAS (5.3 ± 2.9 vs. 5.3 ± 3.0 points, p = 0.34). Using NRS, patients rated their pruritus significantly higher than with VAS (5.7 ± 2.6 points, p < 0.01). VRS showed the highest correlation with NRS (R = 0.82, p < 0.001), followed by horizontal (R = 0.75, p < 0.001) and vertical VAS (R=0.74, p < 0.001). Based on detailed analysis following VAS categories were proposed: 0 = no pruritus, > 0-< 4 points = mild pruritus, ≥ 4-< 7 points = moderate pruritus, ≥ 7-< 9 points = severe pruritus, and ≥ 9 points = very severe pruritus. In conclusion, the VAS is a valuable method of pruritus measurement.

Nail psoriasis in Germany: epidemiology and burden of disease

Background  Although nail psoriasis affects a marked proportion of patients with psoriasis and causes significant psychological stress, only few epidemiological data characterizing patients with nail involvement are available.

Prevalence of chronic pruritus in Germany: results of a cross-sectional study in a sample working population of 11,730.

Background: Pruritus is a frequent symptom in many diseases; its prevalence in German adults is unknown. Objective: Our purpose was to assess the prevalence, severity and health care of chronic pruritus in the German working population. Methods: A cross-sectional observational study was conducted in employees of 144 German companies. Pruritus-specific data were obtained by standardized questions. Results: 11,730 people (53.2% male, 16–70 years, mean = 43.7 years) were suitable for analysis. The point prevalence of chronic pruritus (at least 6 weeks prior to data collection) was 16.8%. The prevalence increased with age from 12.3% (16–30 years) to 20.3% (61–70 years). A quarter of the affected persons had suffered from pruritus for >5 years, 47% had never sought medical advice, and 94% had not undergone any treatment. Conclusions: Chronic pruritus is a prevalent symptom in the working age population. A high proportion of people affected are not medically treated.

The patient benefit index: a novel approach in patient-defined outcomes measurement for skin diseases

Evaluation of therapeutic benefits from the patient’s perspective is important in medical decision-making and reimbursement. This study aimed at developing and validating an instrument on patient-defined needs and benefits in dermatology. The questionnaire was developed according to international guidelines. The benefit assessment consists of two steps: before treatment, every patient defines his treatment needs according to a standardized list. After treatment, the patient rates the degree of benefits achieved. A “patient benefit index” (PBI) is calculated by averaging the preference-weighed results of all items. The PBI questionnaire was validated in a sample of 500 patients with ten skin diseases and in a treatment study on 906 patients with acne. The patients defined a broad spectrum of needs and treatment benefits, indicating disease-specific patterns. The PBI showed good feasibility, reliability (Cronbach’s alpha >0.91) and construct validity, high responsiveness, and discrimination between subgroups. The PBI permits valid evaluation of patient-relevant benefits in dermatological treatment.

Pruritus Assessment in Clinical Trials: Consensus Recommendations from the International Forum for the Study of Itch (IFSI) Special Interest Group Scoring Itch in Clinical Trials

Chronic pruritus is a common symptom and there is an urgent need to test new anti-pruritic substances in high-quality clinical trials. However, no widely accepted standardized and validated method for objectively measuring pruritus is yet available. A special interest group of the International Forum for the Study of Itch has been established to assess scoring methods and questionnaires for use in clinical trials. This paper presents our current recommendations. The set of measures we recommend includes pruritus intensity scales, instruments for assessment of scratch lesions, chronic pruritus course, quality of life and patient benefits.

Quality of life and satisfaction of patients with leg ulcers--results of a community-based study.

BACKGROUND Leg ulcers have a major socio-economic impact because of their frequency and societal costs. Patients with leg ulcers experience major Health related Quality of Life (HrQoL) impairments. The aim of the present study was to assess the disease-specific HrQoL and the influence of care on HrQoL with leg ulcer. PATIENTS AND METHODS A cross-sectional study was conducted in the metropolitan area of Hamburg to assess the quality of care as well as HrQoL in an unrestricted sample of patients with leg ulcers by questionnaires and subsequent clinical examinations. RESULTS A total of 530 patients were consecutively recruited across all wound care provider sections in the metropolitan area of Hamburg. 53 % of the patients were highly or very satisfied with the health services provided. Significant correlations were found between the disease-specific HrQoL, patient satisfaction and satisfaction with wound treatment. Furthermore, significant predictors of HrQoL were: inadequate pain therapy, insurance status, wound size, time required for dressing changes and wound etiology. Most relevant predictors for satisfaction with health services were: HrQoL, duration of wound, health insurance status and treatment by office-based physicians. In contrast, no statistically significant association with HrQoL and satisfaction was found for gender, living district, education, number of dressing changes per week and the number of comorbidities. CONCLUSIONS The results show that chronic leg ulceration has a major impact on patients HrQoL. Clinical and treatment characteristics, but not socio-demographic data, were predictors of HrQoL and satisfaction with health services. The systematic assessment of HrQoL in patients with leg ulcers across all sectors of health-care is a novum and provides important insights into the reality and quality of care.

Verbalizing extremes of the visual analogue scale for pruritus: a consensus statement.

Itch (pruritus) is an unpleasant sensation that leads to the desire to scratch (1). Pruritus may compromise quality of life and sleep in affected individuals. Pruritus is simi -lar to pain, in being a subjective symptom; assessment of its intensity is a key issue in evaluating severity and therapeutic outcome of patients with pruritic disorders of diverse origins (cutaneous, systemic, neuropathic, psychogenic) (2). Various types of rating scales have been used and validated in the study of clinical itch, including the visual analogue scale (VAS), numerical rating scale, verbal rating scale, and behavioural rating scale (2–4). Among these measurement tools, the VAS seems to be one of the most commonly used methods of assessing pruritus severity, as it provides an easy and rapid estima -tion of itch (3, 4). The VAS is a 10-cm long line, oriented horizontally or vertically, on which patients indicate the intensity of pruritus by marking the line at the point that corresponds to the severity of their pruritus, where the beginning of the scale refers to no pruritus (0 point) and the end of the scale to the most severe pruritus (10 points) (3, 4). On behalf of the International Forum for the Study of Itch (IFSI), we discussed methodological problems of the VAS in clinical settings. During our discussion we identified that it is necessary to clarify the verbal expres-sion of the 10-point end, because it varies from study to study. It includes expressions such as “worst imaginable itch”, “the most severe pruritus they can imagine”, “most intense sensation imaginable”, “maximal itch”, “severe itching” and “unbearable pruritus” (3–8). In this report, we propose to consolidate the verbalization of extremes of VAS for “itch intensity” and “sleep disturbance (noc-turnal itch)”.CONSENSUS STATEMENTMembers of the Japanese Society for Dermatoallergo -logy and Contact Dermatitis (JSDACD) (MF, TE, AI, ST, YK, KT, TS, and HS) discussed possible core items for evaluating pruritus in clinical settings, including clinical trials, in Japan. Nine items were proposed and we evaluated the importance of each item by assigning a weight score (maximum points, 10) to each. The 2 highest-ranked items were “itch intensity” (score, 10

The “Wound‐QoL”: A short questionnaire measuring quality of life in patients with chronic wounds based on three established disease‐specific instruments

The aim of this study was to develop a short questionnaire measuring health‐related quality of life (HRQoL) in chronic wounds. Three validated instruments assessing HRQoL in chronic wounds—the Freiburg Life Quality Assessment for wounds, the Cardiff Wound Impact Schedule, and the Würzburg Wound Score—were completed by 154 German leg ulcer patients in a longitudinal study. For implementation in the new, shorter questionnaire Wound‐QoL, all of those 92 items that covered the core content of the three questionnaires and showed good psychometric properties were selected. Internal consistency, convergent validity, and responsiveness were analyzed using the study data on the selected items (a new approach called virtual validation). Subscales were determined with factor analysis. Item, instruction, and response scale wording were harmonized. Seventeen items were included in the Wound‐QoL, which could be attributed to three subscales on everyday life, body, and psyche. Both global score and subscale scores were internally consistent with Cronbachs alpha between 0.71 and 0.91. The global score showed significant convergent validity (r = 0.48 to 0.69) and responsiveness (r = 0.18 to 0.52); the same was true for the subscale scores. The Wound‐QoL for measurement of HRQoL in chronic wounds proved to be internally consistent, valid, and responsive in German leg ulcer patients. The findings of this virtual validation study need to be confirmed in a longitudinal validation study on the final Wound‐QoL, which is currently being conducted.