Stephan Jeff Rustenbach

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.

Cost-of-illness of chronic leg ulcers in Germany

Chronic wounds are important because of their frequency, their chronicity and high costs of treatment. However, there are few primary data on the cost‐of‐illness in Germany. The aim was to determine the cost‐of‐illness of venous leg ulcers (VLU) in Germany. Prospective cost‐of‐illness study was performed in 23 specialised wound centres throughout Germany. Direct, medical, non medical and indirect costs to the patient, statutory health insurers and society were documented. Thereover, health‐related quality of life (QoL) was recorded as intangible costs using the Freiburg quality of life assessment for wounds (FLQA‐w, Augustin). A total of 218 patients (62.1% female) were recruited consecutively. Mean age was 69.8 ± 12.0 years. The mean total cost of the ulcer per year and patient was €9569, [€8658.10 (92%) direct and €911.20 (8%) indirect costs]. Of the direct costs, €7630.70 was accounted for by the statutory health insurance and €1027.40 by the patient. Major cost factors were inpatient costs, outpatient care and non drug treatments. QoL was strikingly reduced in most patients. In Germany, VLU are associated with high direct and indirect costs. As a consequence, there is a need for early and qualified disease management. Deeper‐going cost‐of‐illness‐studies and cost‐benefit analyses are necessary if management of chronic wounds is to be improved.

Prevalence of skin diseases in a cohort of 48,665 employees in Germany.

Background: Epidemiological data are important for planning medical care. Thus far, only few prevalence data for skin diseases have been published in Germany, most of them not population based. Objectives: Estimation of prevalences of common skin diseases in a sample of employees of German companies. Methods: Whole-body examinations were performed by trained dermatologists in 150 companies as part of skin cancer screenings. Using a standardized and computerized data entry, all clinical dermatological findings were documented. Explicitly skin lesions requiring current treatment were noted. The retrospective evaluation of the data was descriptive, using the diagnoses defined a priori in the data entry mask. Results: 48,665 persons (52.8% male) with a mean age of 43.2 years were examined. The following frequencies of chronic and acute inflammatory skin diseases were observed: contact eczema 8.9%, acne 4.2%, seborrhoeic eczema 3.4%, rosacea 2.2%, psoriasis vulgaris 2.1%, atopic eczema 1.4% and lichen ruber 0.07%. In total, dermatological findings needing treatment were observed in 19% of the study cohort; 1.3% of the participants presented a suspicious finding requiring diagnostics for skin malignoma. Conclusions: There is a high frequency of chronic inflammatory skin diseases in the general working population and a high need for dermatological treatment.

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.

Concordance of the Psoriasis Area and Severity Index (PASI) and patient-reported outcomes in psoriasis treatment

A prospective observational study was conducted to analyze to what extent the Psoriasis Area and Severity Index (PASI) is correlated to patient reported outcomes (PRO). Data were collected on 93 outpatients with psoriasis prior to (t1) and after therapy (t2). A higher PASI score was associated with impaired Quality of Life (DLQI), however associations were only weak (R = 0.24 on t1 and R = 0.36 on t2). The average improvement in PASI score was correlated moderately highly with the change of DLQI (R = 0.50) as well as with the PBI (R = 0.45). The threshold values PASI-50 and PASI-75 were likewise positively associated with PRO, but they only incompletely reflect them: about half of the patients with PASI-50 did not see their expectations met (46.9%) or were not satisfied with the condition of the skin after treatment (56.3%). A quarter of these patients experienced no benefits from the therapy. Of the patients with PASI-75, 15.4% were not satisfied with the condition of their skin. In contrast, 36% of patients who did not attain PASI-50 specified a high level of treatment satisfaction. PASI and PRO are associated but based on different concepts. In addition to clinicial severity, patient-defined benefits should be implemented in the evaluation of psoriasis care.

Cost-of-illness of leg ulcers in the community.

Leg ulcer management is complex, time‐consuming and of high socio‐economic importance. Data on cost‐of‐illness in leg ulcer care are sparse. The objective of this study was to evaluate the cost‐of‐illness in leg ulcer treatment in the metropolitan area of Hamburg. About 147 institutions involved in wound care participated in a cross‐sectional study. Patients consecutively recruited underwent a standardised interview and clinical examination. Main economic outcomes were direct, indirect and intangible costs from a societal perspective. Five hundred and two patients with a mean age of 71 years and mean wound duration of 9 years were enrolled. Annual total costs summed up to a mean of 9060€ /patient/year (8288€ direct, 772€ indirect costs). Direct costs carried by statutory health insurances amounted to 7680€ , patients themselves paid on average 607€. Leg ulcer is associated with high costs for health insurances, patients and the society. Exploratory predictor analyses suggest that early, interprofessional disease‐management could lower treatment costs.

German psoriasis registry PsoBest: objectives, methodology and baseline data.

The German psoriasis registry PsoBest records the long‐term efficacy, safety, patient benefit and treatment regimens of psoriasis.

Evaluation of Quality of Care and Guideline-Compliant Treatment in Psoriasis

Background: To date, no standardised indicators for quality of care in psoriasis have been published. Aims: Development and testing of evidence-based indicators of quality of care and guideline compliance in the treatment of psoriasis. Methods: Indicators of process and outcome quality were extracted and evaluated in a Delphi process according to international standards. The primary reference was the S3 German guideline for psoriasis treatment. The indicators were validated with data from two nationwide studies on psoriasis care involving 1,511 and 2,009 patients. Results: Eight quality indicators were defined: mean PASI, mean quality of life (Dermatology Life Quality Index; DLQI), proportion of patients with PASI >20, with DLQI >10, with previous systemic treatment, with PASI >20 and systemic treatment, with inpatient treatment, and number of work days lost. All indicators proved suitable for application, and were sensitive to change. Conclusions: Guideline-based indicators of quality of care are useful in the analysis of health care and the implementation of treatment guidelines in psoriasis.

Effectiveness of Advanced versus Conventional Wound Dressings on Healing of Chronic Wounds: Systematic Review and Meta-Analysis

Background: Wound dressings are essential in the treatment of chronic wounds and should be selected on valid and recent evidence. Objective: Effectiveness of advanced compared to conventional dressings for chronic wound healing. Methods: Comprehensive literature search, systematic review and meta-analyses of the results of advanced dressing studies on chronic wound treatment. Comprehensiveness and coverage of all relevant studies is the most striking difference in relation to other meta-analyses and systematic reviews. Results: The mean odds ratio of complete healing was 1.52 favouring advanced over conventional dressings in 65 controlled trials. In 287 study conditions including uncontrolled studies, mean odds were 0.97 (advanced dressings/controlled studies), 0.77 (conventional/controlled) and 0.47 (advanced/uncontrolled). The overall healing rate was 33%. When causal treatment was applied, a reduced effect was observed. The consideration of all types of chronic wounds, advanced wound dressings and studies resulted in more study effects, more reliable estimates of mean effects and more statistical power. These differences in the design are likely to explain the differences in the meta-analytic results. Conclusion: A general superiority of advanced dressings on complete healing was shown. The generalizability of the results is limited by the methodological and report quality within studies identified, unexplained heterogeneity in study effects and possibly by publication bias.

Benefit Evaluation in Vitiligo Treatment: Development and Validation of a Patient-Defined Outcome Questionnaire

Background: In addition to clinical efficacy, patient-defined benefit assessment has become an important outcome parameter. Thus far, no such instrument has been developed for vitiligo. Objectives: Development and validation of a patient-defined benefit questionnaire in the therapy of vitiligo. Methods: Open questioning of 50 vitiligo patients generated 110 benefit items, which were converted into a 26-item questionnaire by a panel of dermatologists, psychologists and patients. This was used to record patient-defined needs prior to therapy and to evaluate patient benefit attained after therapy. A ‘patient benefit index’ (PBI) was formed on the basis of both. Validation was based on data of n = 1,023 vitiligo patients. Results: The questionnaires were feasible in clinical practice, Cronbach’s α (patient need questionnaire) was 0.94. The PBI showed convergent and discriminant validity with respect to quality of life and patient satisfaction. Conclusion: The PBI for vitiligo is a valid instrument, which is highly accepted in practice for recording patient-reported benefit.