[Digital health applications and data protection]. / Digitale Gesundheitsanwendungen und Datenschutz.

Digital health applications represent a new form of care. The basis for the approval of digital health applications is the Digital Healthcare Act. In order to be included in the directory, the digital health applications must undergo an extensive evaluation process by the Federal Institute for Drugs and Medical Devices. The focus is on proving added value for care, but also on the technical aspects. This strictly differentiates the digital health applications from the health apps. Cutting-edge apps enable a simple output of collected data to make doctor-patient interactions efficient. Appropriate remuneration and education could increase the acceptance by the medical profession and thus accelerate implementation; however, such instruments and incentives are not currently provided for in the system.

Quality of psoriasis care in Germany - results from the nationwide health care studies PsoHealth 2004-2017.

BACKGROUND: In the study series PsoHealth first data from 2004/05 showed a poor quality of health care for psoriasis in Germany. Most patients lacked sufficient care and only a minor proportion received systemic drugs. Since 2007, a national psoriasis programme has been conducted. OBJECTIVES: (1) To analyse the quality of health care for psoriasis in the most recent PsoHealth4 survey 2016/17, (2) to compare health care quality indicators with prior assessments since 2004/05. MATERIALS AND METHODS: The recent cross-sectional PsoHealth4 survey was conducted 2016/17, and three preceding studies were performed in 2004/05, 2007 and 2013/14, each including at least 1500 patients. The common set of quality indicators included disease severity (PASI and proportion of patients with PASI > 20, indicating high severity), quality of life (DLQI and proportion of patients with DLQI > 10, indicating strong impairments in quality of life), systemic therapy and inpatient treatment of the last five years. RESULTS: Between December 2015 and December 2017, n = 1827 patients from 93 dermatological centres were included in the most recent survey (mean age: 50.8 ± 14.6 years, 45.2% female). 7.3% showed a PASI > 20, compared to 17.8% in 2004/05. 21.4% reported a DLQI > 10, compared to 34.0% in 2004/05. 57.6% of all participants stated to have received a systemic therapy at least once within the last five years, compared to 32.9% in 2004/05. 18.0% received inpatient hospital treatment at least once within the last five years, compared to 26.9% in 2004/05. CONCLUSION: A remarkable improvement in the health care quality for psoriasis patients in Germany within the past 12 years can be assumed. Major determinants could be the innovation shift which included programmes such as the S3 guideline, a consensus on treatment goals, national health care goals for psoriasis and higher utilisation of innovative drugs.

EuroGuiDerm Guideline on the systemic treatment of Psoriasis vulgaris - Part 2: specific clinical and comorbid situations.

This evidence- and consensus-based guideline on the treatment of psoriasis vulgaris was developed following the EuroGuiDerm Guideline and Consensus Statement Development Manual. The second part of the guideline provides guidance for specific clinical and comorbid situations such as treating psoriasis vulgaris patient with concomitant psoriatic arthritis, concomitant inflammatory bowel disease, a history of malignancies or a history of depression or suicidal ideation. It further holds recommendations for concomitant diabetes, viral hepatitis, disease affecting the heart or the kidneys as well as concomitant neurological disease. Advice on how to screen for tuberculosis and recommendations on how to manage patients with a positive tuberculosis test result are given. It further covers treatment for pregnant women or patients with a wish for a child in the near future. Information on vaccination, immunogenicity and systemic treatment during the COVID-19 pandemic is also provided.

EuroGuiDerm Guideline on the systemic treatment of Psoriasis vulgaris - Part 1: treatment and monitoring recommendations.

This evidence- and consensus-based guideline on the treatment of psoriasis vulgaris was developed following the EuroGuiDerm Guideline and Consensus Statement Development Manual. The first part of the guideline includes general information on the scope and purpose, health questions covered, target users and strength/limitations of the guideline. Suggestions for disease severity grading and treatment goals are provided. It presents the general treatment recommendations as well as detailed management and monitoring recommendations for the individual drugs. The treatment options discussed in this guideline are as follows: acitretin, ciclosporin, fumarates, methotrexate, adalimumab, apremilast, brodalumab, certolizumab pegol, etanercept, guselkumab, infliximab, ixekizumab, risankizumab, secukinumab, tildrakizumab and ustekinumab.

[Social rights claims for malignant melanoma patients : Providing patient information in German dermatological practices]. / Sozialrechtliche Ansprüche beim malignen Melanom : Aufklärung von Patienten in deutschen dermatologischen Praxen.

BACKGROUND: Treatment of patients with malignant melanoma includes informing the patients about their rights regarding social/disability benefits. In particular, every patient has the right to rehabilitation treatment according to SGB V and IX (SGB: Sozialgesetzbuch; Social Security Code) and to an examination regarding the classification of the disability. OBJECTIVES: The present study examines the extent to which patients with invasive malignant melanoma are informed after initial diagnosis about their social rights to medical rehabilitation measures and the classification of disability. MATERIALS AND METHODS: In the course of a survey in 2014, n = 1800 German dermatological practices were contacted and provided a standardized questionnaire on several care-relevant questions, including the aforementioned ones. RESULTS: Evaluable questionnaires were submitted by n = 424 practices. In all, 52% of dermatologists stated that they regularly provided information on the right to rehabilitation, 15% sometimes, 41% rarely or never. Furthermore, 44% of dermatologists regularly, 17% sometimes and 38% rarely or never informed their patients about the classification of disability. Relevant differences were found in regional comparisons. CONCLUSIONS: Practicing dermatologists seem to transfer the information requirement to the clinics involved in the treatment. It would be beneficial if the information were also provided again by the dermatologists in private practice. In view of the known limited capacity to receive new information from patients with newly diagnosed melanoma, repeated counselling appears to be more patient-friendly.

Cost-of-illness of psoriasis - results of a German cross-sectional study.

BACKGROUND: Though psoriasis poses a substantial chronic socio-economic burden, few studies have addressed the economic impact in Germany. OBJECTIVES: The objective was to evaluate the annual costs of psoriasis in Germany from the societal perspective. METHODS: A cross-sectional study was performed in randomly selected German dermatology practices and clinics in 2013/2014 using standardized questionnaires of illness-related costs. Costs were grouped by perspective and category as well as analysed by sex and age. Group differences were tested by non-parametric tests. RESULTS: Complete data were obtained from 1158 patients in 132 centres. Annual average costs for patients with psoriasis: total costs € 5543 ± € 8044, systemic treatment costs (paid by the statutory health insurances [SHI]) € 3733 ± € 7322, out-of-pocket costs € 224 ± € 406, total SHI costs € 4940 ± € 7533, direct costs € 5164 ± € 7581 and indirect costs € 379 ± € 2087. Significant higher costs in male and significant lower costs in 65+-year-old patients were found. CONCLUSIONS: Psoriasis induces a considerable economic burden. Between 2003 and 2014, costs have markedly shifted from hospital, out-of-pocket and indirect costs towards systemic drug costs.

Patient-reported health outcomes in patients with non-melanoma skin cancer and actinic keratosis: results from a large-scale observational study analysing effects of diagnoses and disease progression.

BACKGROUND: Non-melanoma skin cancer (NMSC) and actinic keratosis (AK) are very common among fair-skinned individuals. A disease continuum from AK to squamous cell carcinoma (SCC) has been frequently postulated. AK and NMSC may influence quality of life (QL) of patients, and it can be suspected that disease progression entails a QL reduction. The purpose of this study was to document QL in patients with NMSC and AK using the health-outcome questionnaire EQ-5D-5L. METHODS: The study was designed as a non-interventional, prospective, cross-sectional study. Patients with AK, SCC, basal cell carcinoma (BCC) or multiple diagnoses were enrolled in this study in 29 dermatological centres across Germany. Patients were asked to complete the EQ-5D-5L (compromising EQ Index and EQ VAS), and the dermatologists provided diagnosis, disease history and treatment data. RESULTS: A total of 1184 patients were enrolled and diagnosed as follows: 73% AK, 49% BCC and 17% SCC. 66% had a single diagnosis, 28% two different diagnoses and 6% three different diagnoses. QL was strongly associated with patients' diagnosis. Patients with a single AK diagnosis had significantly higher mean EQ VAS (78) than patients with BCC (74), SCC (72), and BCC plus SCC (69), P < 0.050. When the effects of disease progression were calculated, patients with AK plus SCC reported significantly less mean EQ VAS (71) than patients with a single AK diagnosis (78), P < 0.011. CONCLUSIONS: While rarely being imminently life-threatening, NMSC and AK have an impact on QL as quantified by the EQ-5D-5L. This impact is associated with diagnosis (AK vs. NMSC) and clinical progression (AK vs. AK plus SCC). Both lead to a clear decline in QL. This shows that disease progression is perceived and judged as detrimental by patients and that AK and NMSC should be diligently treated to preserve and restore QL.

Perception and image of dermatology in the German general population 2002-2014.

BACKGROUND: In contrast to other European countries, dermatologists in Germany provide health care for a broad spectrum of diseases of the skin and mucous membranes. Current population-based data on the perception of dermatology were lacking to date. OBJECTIVE: Analysis of the perception of dermatology from the general population's perspective with regard to utilization, satisfaction and responsibility. METHODS: Nation-wide survey on awareness, utilization, rating and image of dermatology in October 2014 through computer-assisted telephone interviews on a representative sample of the adult general population (n = 1015), performed by the FORSA institute. RESULTS: Dermatologists as a medical specialist group are familiar to 88% of the population (2002: 65%), and approx. 82% of respondents underwent dermatological treatment in the past. Satisfaction with this treatment is high to very high in 80-90% of respondents. The majority (60-80%) name dermatologists as the desired primary provider of care for the largest share of common skin diseases. For allergic diseases, mucous membrane diseases, venous disorders and paediatric skin diseases, this rate is significantly below 50%. CONCLUSIONS: In Germany, dermatologists are perceived and valued as providers of care. In the case of skin cancer and chronic inflammatory skin diseases, they are experienced as primary care givers, whereas they are associated less frequently than their competence would justify with providing treatment for allergic and mucous membrane diseases and venous disorders. Further education of the general public and medical profession is required.

[Perception of statutory skin cancer screening in the general population : Current findings on participation, knowledge and evaluation]. / Die Wahrnehmung des gesetzlichen Hautkrebsscreenings in der Allgemeinbevölkerung : Aktuelle Erkenntnisse über Teilnahmequote, Kenntnisstand und Beurteilung.

BACKGROUND: Since 2008, German statutory health insurances offer routine skin cancer screening (rSCS) as a standard benefit. Insured persons aged 35 years and older are eligible for screening every 2 years. OBJECTIVES: The aim of the study was to evaluate perception and utilization of rSCS in the general population. MATERIALS AND METHODS: A representative random sample of n = 1004 adult members of the German statutory health insurances were surveyed by the Forsa Institute via computer-assisted telephone interviews in a cross-sectional study in April 2015. RESULTS: On 39% of all persons interviewed, skin cancer screening had been executed at least once; the percentage of those entitled for rSCS was 45%. Of the participants, 50% were aware of the rSCS eligibility framework, with multiple sources of information. In 82% of cases, rSCS was performed by a dermatologist. The majority (87%) of those who had already undergone rSCS stated that the advantages of the procedure outweighed inconveniences. While participation in rSCS constantly increased (2011-2013-2015), knowledge of eligibility did not. CONCLUSIONS: Seven years after implementation, rSCS has been utilized by almost half of those entitled and was rated positively by the majority. However, lack of knowledge about rSCS eligibility is also present in 50%. Further targeted informative measures are needed to increase awareness of rSCS.

The German National Program on Psoriasis Health Care 2005-2015: results and experiences.

In 2005, the first national psoriasis survey in Germany revealed large deficits in health care particularly in patients with moderate to severe disease. The consecutive goal was to improve health care for psoriasis countrywide. For this, a large-scale national program was initiated starting with a comprehensive analysis of structures and processes of care for psoriasis. Patient burden, economic impact and barriers to care were systematically analyzed. In order to optimize routine care, a S3 guideline, a set of outcomes measures and treatment goals, were developed. Implementation was enforced by the German Psoriasis Networks (PsoNet) connecting the most dedicated dermatologists. The annual National Conference on Health Care in Psoriasis established in 2009 consented National Health Care Goals in Psoriasis 2010-2015 and defined a set of quality indicators, which are monitored on a regular basis. Currently 28 regional networks including more than 800 dermatologists are active. Between 2005 and 2014 7 out of 8 quality indicators have markedly improved, and regional disparities were resolved. e.g., mean PASI (Psoriasis Area Severity Index) dropped from 11.4 to 8.1 and DLQI (Dermatology Life Quality Index) from 8.6 to 5.9. A decade of experience indicates that a coordinated nationwide psoriasis program based on goal orientation can contribute to better quality of care and optimized outcomes.

Nickel sensitivity in atopics, psoriatics and healthy subjects.

A prospective study of 552 persons was performed to study nickel allergy in atopics, with and without dermatitis, psoriatics and healthy adults. We found no statistically-significant difference in the frequency of nickel allergy between persons with atopic dermatitis, atopics without dermatitis and healthy controls. More females than men gave a history of metal intolerance and gave allergic patch test reactions. A poor correlation between history and patch test reaction was not specific for atopics. Psoriatics had a significantly lower frequency of allergic patch test reactions to nickel than healthy controls or atopics with and without dermatitis. Psoriatics should not be used as controls for atopics in studies of contact dermatitis.