Search

Background and purpose This systematic review summarised and critically appraised evidence on the efficacy and safety of interventions for anal cancer to support the panel of experts developing the national evidence-based anal cancer guideline in Germany. Materials and methods We conducted a systematic review and meta-analyses of interventions for the treatment of stage I to III anal squamous cell carcinoma (SCCA). We systematically searched several databases and included any randomised controlled trial (RCT) assessing the pre-specified patient populations, regardless of the interventions studied. Non-randomised controlled studies of selected, pre-specified interventions were included if RCTs were not available or contained insufficient information. Where possible, we conducted meta-analyses and critically assessed confidence in the effect estimates using the GRADE approach. Results Our searches yielded 10,325 (25 October 2018) and 889 hits (update search on 18 July 2019). Among the 41 studies (47 publications) included, we identified 19 comparisons of interventions for SCCA, and confidence in the effect estimates ranged from very low to high. Most RCTs compared various chemoradiation regimes. For other treatment options, such as local excision in early stages or different radiotherapies, we mostly identified comparative cohort studies. Conclusion Our findings indicate that, in most clinical situations, primary chemoradiation based on 5-FU and MMC is still the gold standard. However, treatment options for stage I anal cancer, particularly of the anal margin, as well as newer treatment approaches should be investigated in future RCTs. Overall, our findings may help health care professionals and patients make informed decisions about treatment choices.

Anogenital and oropharyngeal infections with human papilloma viruses (HPV) are common. Clinically manifest disease may significantly impact quality of life; the treatment of HPV-associated lesions is associated with a high rate of recurrence and invasive neoplasms, such as cervical, anal, vulvar, penile, and oropharyngeal cancers, which are characterized by significant morbidity and mortality. Vaccination against HPV is an effective and safe measure for the primary prevention of HPV-associated lesions, but immunization rates are still low in Germany. The present publication is an abridged version of the German evidence and consensus-based guideline "Vaccination recommendations for the prevention of HPV-associated lesions", which is available on the website of the German Association of the Scientific Medical Societies (AWMF). On the basis of a systematic review with meta-analyses, a representative panel developed and agreed upon recommendations for the vaccination of different populations against HPV. In addition, consensus-based recommendations were developed for specific issues relevant to everyday practice. Based on current evidence and a representative expert consensus, these recommendations are intended to provide guidance in a field in which there is often uncertainty and in which both patients and health care providers are sometimes confronted with controversial and emotionally charged points of view.

Objective We aimed to generate evidence on patients’ values and preferences to inform the development of the German national Evidence-based Anal Cancer Guideline. Study Design and Setting We developed a list of health outcomes based on a systematic search. We then asked anal cancer patients and experts of the guideline development group in an online survey to (a) rate the relative importance of the outcomes in different clinical situations using a nine-point, three-category scale, and (b) select seven outcomes they considered most important for decision-making in each situation. Results Participants rated almost half of the outcomes (45%) as critical for decision-making, and more than half (53%) as important. Only two outcomes (2%) were rated as low in importance. Agreement between expert and patient ratings was low to fair, and we found important discrepancies in how the relative importance of the outcomes was perceived. However, the rankings of outcomes were highly correlated. Conclusion Determining the relative importance placed by anal cancer patients on outcomes provided useful information for developing guideline recommendations. Our approach may be useful for guideline developers who aim to include the patient perspective. Moreover, our findings may help health professionals caring for anal cancer patients in joint decision-making.

Pruritus ani (analer Juckreiz) ist ein in der Praxis haufig auftretendes Symptom, das bei Chronifizierung mit hohem Leidensdruck einhergeht. In der Regel tritt analer Pruritus sekundar als Symptom verschiedener Krankheitsbilder, u. a. aus dem Spektrum dermatologischer, proktologischer, allergologischer oder mikrobieller Erkrankungen, auf. Die Identifikation und spezifische Behandlung der zugrundeliegenden Ursache ist in diesen Fallen essenziell. Lasst sich keine zugrundeliegende Erkrankung eruieren, spricht man von einem idiopathischen (primaren) Pruritus ani. Wie auch bei der Behandlung des Analekzems hangt der mittel- und langfristige Therapieerfolg im Management des Pruritus ani von verschiedenen Elementen der Behandlung ab, die sich grob in kausale, unterstutzende und symptomatische Masnahmen unterteilen lassen. Im vorliegenden Beitrag werden u. a. die Empfehlungen der aktualisierten Leitlinie „Analer Pruritus“ (AWMF-Reg. 013/063) vorgestellt.

Perianal dermatitis (anal eczema, perianal eczema) is one of the most common proctological conditions. It may occur as a sequela or a presenting symptom of various proctological, dermatological, allergic or pathogen-induced disorders. The three main types of anal eczema are irritant-toxic, atopic and allergic contact dermatitis. Adequate and successful treatment requires a comprehensive diagnostic workup to determine disease etiology and includes treatment/elimination of causative factors as well as nonpharmacological interventions (avoidance of aggravating factors). In addition, adjuvant topical anti-inflammatory and/or specific symptomatic treatment may be required. The present guidelines contain recommendations for the diagnostic and therapeutic management of perianal dermatitis. Target users of these guidelines are clinicians in the fields of dermatology and proctology, as well as all other specialties involved in the management of patients with perianal dermatitis, both in hospital and office-based settings.

Das Analkarzinom ist mit einem Anteil von bis zu 5 % aller Karzinome im Gastrointestinaltrakt relativ selten. Dieser Beitrag beschrankt sich auf das Plattenepithelkarzinom des Analkanals und des Analrands, das haufig mit einer Infektion durch das humane Papillomavirus assoziiert ist. Das Plattenepithelkarzinom macht weit uber 90 % der Analkarzinome aus. Die Diagnose ist mit Inspektion (Analrandkarzinom) und digital-rektaler Untersuchung sowie Proktoskopie (Analkanalkarzinom) relativ einfach zu stellen. Die Biopsie/Exzision des Tumors sichert die Diagnose. Abhangig vom Stadium ist die Therapie in Zusammenarbeit mit Strahlentherapeuten zu koordinieren. Kleine, gut differenzierte Analrandkarzinome konnen mit einer R0-Exzision gut behandelt werden. Fur Analkanalkarzinome ist die kombinierte Radiochemotherapie (RCT) die Standardtherapie. Die definitive RCT fuhrt in bis zu 70 % der behandelten Falle zu einer kompletten Remission. Die Nachsorge sollte ein Koloproktologe ubernehmen.

Diese Leitlinie richtet sich an Assistenz- und Facharzte der Dermatologie, Padiatrie, Kinderdermatologie und Kinderrheumatologie sowie an Kostentrager und politische Entscheidungsgremien. Die Leitlinie wurde im formellen Konsensusverfahren (S2k) von Dermatologen und Kinderdermatologen unter Einbindung von Kinderrheumatologen erstellt. Die Leitlinie stellt einen Uberblick uber Schweregrad, Lebensqualitat und Therapieziele mit Erlauterung der Off-Label-Problematik im Kindesalter dar. Es werden Diagnosestellung und Triggerfaktoren erlautert. Der Schwerpunkt der Leitlinie liegt auf der Darstellung der verschiedenen topischen Therapien, UV-Therapien und systemischen Therapieoptionen mit Abbildung der Empfehlungen zur Anwendung der Therapien sowie Therapiealgorithmen. Daruber hinaus wird im Kontext auf Impfungen bei Psoriasis im Kindesalter sowie auf verschiedene Sonderformen wie Psoriasis guttata, Windelpsoriasis, Psoriasis pustulosa und Psoriasis-Arthritis eingegangen. Auch werden Empfehlungen zu Tuberkulosediagnostik und Rontgenuntersuchung vor Systemtherapie gegeben.

Psoriatic arthritis (PsA) is associated with progressive joint destruction and reduced quality of life. The time until a drug treatment starts to show an effect (TOA) is important for preventing joint destruction. The objective was to assess the time until onset of action of drugs when treating PsA. A systematic review of PsA drug trials was performed. Outcomes were: time until 25% of patients (TOA) reached (1) ≥ 20%, (2) ≥ 50% improvement in modified American College of Rheumatology response criteria (ACR), (3) ≥ 75% reduction in Psoriasis Area and Severity Index (PASI75). 95% confidence intervals were calculated extracting data from graphs using a novel method. Meta-analysis was conducted. Two head-to-head trials show no difference between ixekizumab and adalimumab or adalimumab and tofacitinib for TOA-ACR outcomes. For PASI75, ixekizumab had a faster onset than adalimumab. Infliximab plus MTX was faster than MTX alone. Pooled results from 32 study arms for TOA-ACR20 (week [95% CI]) are:2 weeks: infliximab (1.18 [0.72-1.65]), ixekizumab (1.04 [0.80-1.28]), tofacitinib (10 mg 1.56 [1.14-1.98]); ≤ 4 weeks: adalimumab (1.95 [1.35-2.55]), secukinumab (75 mg 1.89 [0.16-3.62], 150 mg 2.13 [1.34-2.91], 300 mg 2.26 [1.75-2.76]), tofacitinib (5 mg 2.20 [1.41-2.99]); 4 + weeks: apremilast, ustekinumab. For TOA-ACR50, all pooled point estimates are 4 weeks. For TOA-PASI75, the range is between 2.24 [1.65-2.84] for ixekizumab and 6.03 [3.76-8.29] for adalimumab. Indirect, mixed comparison suggest a faster onset of infliximab, ixekizumab and tofacitinib compared to apremilast, methotrexate and ustekinumab for ACR20, not ACR50. For PASI75, ixekizumab is faster than adalimumab.

Background The number of anal cancer diagnoses has been rising steadily, so that the incidence has doubled in the past 20 years. Almost all anal cancers are induced by persistent infection with human papillomaviruses. Hitherto the care of patients with anal cancer has been heterogeneous and little experience exists with the primary management of anal cancer. Methods The guideline was developed in accordance with the requirements of the German Guideline Program in Oncology. In line with the GRADE approach, the certainty of the evidence was assessed on the outcome level following a systematic literature search. Interdisciplinary working groups were set up to compile suggestions for recommendations, which were discussed and agreed upon in a formal consensus conference. Results Ninety-three recommendations and statements were developed. No high-quality evidence was available to support recommendations for or against the treatment of stage I anal cancer with local excision alone as an alternative to chemoradiotherapy. Chemoradiotherapy is the gold standard in the treatment of stages II–III. Among other aspects regarding the timing and extent of response evaluation after chemoradiotherapy, the guideline panel recommended against obtaining a biopsy in the event of complete clinical response. Owing to lack of confidence in the available evidence, only open recommendations were given for treatment of stage IV. Conclusion This evidence-based clinical practice guideline provides a sound basis for optimizing the interdisciplinary, cross-sector care of anal cancer patients. Among other areas, gaps in research were identified with respect to the care of patients with early-stage or metastatic anal cancer. Approaches such as chemoradiotherapy combined with regional deep hyperthermia require further investigation. The role for immunotherapy in the management of metastasized anal cancer has also been insufficiently explored to date.

This guideline is an update from August 2020 the S2k-guideline "Atopic dermatitis" published in 2015. The reason for updating this chapter of the guideline were the current developments in the field of systemic therapy of atopic dermatitis. The agreed recommendations for systemic treatment in atopic dermatitis of the present guideline are based on current scientific data. Due to the approval of dupilumab for the treatment of moderate to severe atopic dermatitis, which cannot be treated sufficiently with topical drugs alone, this part of the guideline has now been adapted and newly consented. The indication for systemic therapy and the therapeutic response to topical and systemic treatment should be recorded and documented in a suitable form in clinic and practice. A standardized documentation of the indication for system therapy in atopic dermatitis can be recommended and is also part of the updated chapter of this guideline.

Clinical practice guidelines are systematically developed decision aids for specific medical conditions. In Germany, national dermatology guidelines are developed chiefly under the aegis of the German Dermatological Society in collaboration with the Professional Association of German Dermatologists. European and international dermatological guidelines also exist and are developed by a range of organisations, such as the European Centre for Guidelines Development, which was founded by the European Dermatology Forum in 2018. In the years 2019 and 2020, new or updated German national guidelines were published on topics such as pathological scars (hypertrophic scars and keloids), cutaneous lupus erythematosus, pyoderma grangrenosum, anal pruritus, anal eczema, anal canal and anal rim carcinomas, as well as the prevention of HPV-associated neoplasms through vaccination, syphilis and the systemic treatment of neurodermitis. A new European guideline on lichen planus closes a gap in the spectrum of guidelines available in Germany. Key recommendations and relevant changes in the guidelines are presented in this article., Medizinische Leitlinien sind systematisch entwickelte Entscheidungshilfen für die angemessene Vorgehensweise bei speziellen gesundheitlichen Problemen. Dermatologische Leitlinien in Deutschland werden führend von der Deutschen Dermatologischen Gesellschaft in Kooperation mit dem Berufsverband Deutscher Dermatologen herausgegeben. Darüber hinaus werden auch europäische und internationale dermatologische Leitlinien erstellt, u. a. durch das im Jahr 2018 vom European Dermatology Forum gegründete European Centre for Guidelines Development. In den Jahren 2019 und 2020 wurden unter anderem deutsche Leitlinien zu den Themen pathologische Narben (hypertrophe Narben und Keloide), kutaner Lupus erythematodes, Pyoderma gangraenosum, analer Pruritus, Analekzem, Analkanal- und Analrandkarzinome, Impfprävention HPV(humane Papillomviren)-assoziierter Neoplasien sowie Syphilis und Systemtherapie bei Neurodermitis überarbeitet oder neu erstellt. Auf der europäischen Ebene schließt die Leitlinie zum Lichen planus eine in Deutschland noch bestehende Lücke der vorhandenen Leitlinien. Schlüsselempfehlungen und wesentliche Neuerungen in den Leitlinien werden hier vorgestellt.

Die vorliegende Leitlinie ist eine Aktualisierung vom August 2020 zu Systemtherapeutika der 2015 publizierten AWMF-S2k-Leitlinie Neurodermitis. Anlass fur die Aktualisierung dieses Kapitels der Leitlinie waren die aktuellen Entwicklungen zur Systemtherapie der Neurodermitis. In der vorliegenden Leitlinie sind die wissenschaftliche Datenlage und die konsentierten Empfehlungen zur Systemtherapie bei Neurodermitis aufgefuhrt. Aufgrund der Neuzulassung von Dupilumab fur die Behandlung mittelschwer bis schwer ausgepragter Neurodermitis, die mit topischen Medikamenten alleine nicht ausreichend behandelbar ist, wurde dieser Teil der Leitlinie jetzt angepasst und neu konsentiert. Die Indikation zur Systemtherapie und das therapeutische Ansprechen auf die topische und systemische Behandlung sollen in Klinik und Praxis in geeigneter Form erfasst und dokumentiert werden. Eine standardisierte Dokumentation der Indikation zur Systemtherapie bei Neurodermitis kann empfohlen werden und ist ebenfalls Bestandteil des hier vorliegenden aktualisierten Kapitels der Leitlinie.

The present guidelines are aimed at residents and board-certified specialists in the fields of dermatology, ophthalmology, ENT, pediatrics, neurology, virology, infectious diseases, anesthesiology, general medicine and any other medical specialties involved in the management of patients with herpes zoster. They are also intended as a guide for policymakers and health insurance funds. The guidelines were developed by dermatologists, virologists, ophthalmologists, ENT physicians, neurologists, pediatricians and anesthesiologists/pain specialists using a formal consensus process (S2k). Readers are provided with an overview of the clinical and molecular diagnostic workup, including antigen detection, antibody tests and viral culture. Special diagnostic situations and complicated disease courses are discussed. The authors address general and special aspects of antiviral therapy for herpes zoster and postherpetic neuralgia. Furthermore, the guidelines provide detailed information on pain management including a schematic overview, and they conclude with a discussion of topical treatment options.

Diese evidenz- und konsensbasierte Leitlinie wurde entsprechend den Methoden der Cochrane und der Grading of Recommendations Assessment, Development and Evaluation (GRADE)-Arbeitsgruppen entwickelt. Die Leitlinien-Konferenz fand am 1. Dezember 2016 statt. Sie ist eine gemeinsame Initiative der European Academy of Allergology and Clinical Immunology (EAACI), dem von der EU gegrundeten Global Allergy and Asthma European Network (GA2LEN), dem European Dermatology Forum (EDF) und der World Allergy Organization (WAO) mit 48 teilnehmenden Delegierten aus 42 nationalen und internationalen Gesellschaften. Die Leitlinie ist von der European Union of Medical Specialists (UEMS) akzeptiert worden. Urtikaria ist eine haufige, mastzellabhangige Erkrankung, die mit Quaddeln, Angioodemen oder beidem einhergeht. Die Lebenszeitpravalenz der akuten Urtikaria liegt bei circa 20 %. Chronische spontane Urtikaria (CSU) und andere chronische Formen der Urtikaria sind belastend, beeintrachtigen die Lebensqualitat und haben einen negativen Einfluss auf die Leistungsfahigkeit in Beruf und Schule. Diese Leitlinie umfasst die Definition und Klassifikation der Urtikaria unter Berucksichtigung der jungsten Fortschritte in der Identifikation von Ursachen, Auslosefaktoren und Pathomechanismen. Daruber hinaus skizziert sie evidenzbasierte, diagnostische und therapeutische Ansatze fur die verschiedenen Subtypen der Urtikaria.

BACKGROUND Most clinical guidelines in dermatology are encyclopaedic, covering a disease and its aetiology, diagnosis, treatment and prevention in their entirety. The usability and uptake of guideline recommendations might be improved by guidelines that are more concise and address specific questions ranked by users according to their perceived importance. OBJECTIVE To survey the largest association of dermatologists in Europe, identify which questions in their everyday practice they felt would benefit from short, evidence-based guidance and rank these systematically. METHODS A two-phase online survey using a structured ranking approach and the members directory of the European Academy of Dermatology and Venereology (EADV). RESULTS The first survey yielded 265 suggestions, indicating a response rate of 3.7%. We grouped all responses according to themes and subsequently combined these into a list of 35 broader topics. These were presented to all members of the EADV in the second survey (response rate: 9.7%), which yielded a list of the top 10 topics participants felt were most in need of guidance. The first three were 'Systemic drug treatment in dermatology during pregnancy and for women wishing to have children in the near future', 'alopecia areata' and 'interpretation of laboratory results in connective tissue diseases'. CONCLUSION Our two-phase survey of EADV members and a structured ranking process were practical to implement and yielded a list of the top 10 topics in dermatology and venereology for guideline development. Guideline dissemination needs to be improved, and practical, more concise guidelines may facilitate efforts to do so.

This evidence- and consensus-based guideline was developed following the methods recommended by Cochrane and the Grading of Recommendations Assessment, Development and Evaluation (GRADE) working group. The conference was held on 1 December 2016. It is a joint initiative of the Dermatology Section of the European Academy of Allergology and Clinical Immunology (EAACI), the EU-founded network of excellence, the Global Allergy and Asthma European Network (GA²LEN), the European Dermatology Forum (EDF) and the World Allergy Organization (WAO) with the participation of 48 delegates of 42 national and international societies. This guideline was acknowledged and accepted by the European Union of Medical Specialists (UEMS). Urticaria is a frequent, mast cell-driven disease, presenting with wheals, angioedema, or both. The lifetime prevalence for acute urticaria is approximately 20%. Chronic spontaneous urticaria and other chronic forms of urticaria are disabling, impair quality of life and affect performance at work and school. This guideline covers the definition and classification of urticaria, taking into account the recent progress in identifying its causes, eliciting factors and pathomechanisms. In addition, it outlines evidence-based diagnostic and therapeutic approaches for the different subtypes of urticaria.

Background Chronic inducible urticaria (CindU) is a condition characterized by the appearance of recurrent wheals, angioedema, or both as a response to specific and reproducible triggers. Objective We sought to systematically assess evidence on the efficacy and safety of treatment options for CindU. Results were used to inform the 2017 update of "The EAACI/GA 2 LEN/EDF/WAO guideline for the definition, classification, diagnosis and management of urticaria." Methods Randomized controlled trials and controlled intervention studies were searched systematically in various databases. Included studies were evaluated with the Cochrane Risk of Bias tool. Where possible, results from single studies were meta-analyzed, applying the Mantel-Haenszel approach by using a random-effects model (Der Simonian–Laird). Results We identified 30 studies that included patients with cold urticaria, symptomatic dermographism, delayed-pressure urticaria, or cholinergic urticaria. No studies on other forms of CindU were eligible. Risk of bias was often rated as unclear or high. Overall, second-generation antihistamines were more effective than placebo, and available data indicate that updosing might be effective. Omalizumab proved effective in patients with symptomatic dermographism, who did not respond to antihistamines. Detailed results are given for each type of CindU. Conclusions The available evidence is limited by small samples, heterogeneous efficacy outcomes, and poor reporting quality in many of the included studies. The findings are congruent with the suggested stepwise approach to treating CindUs. However, the data do not allow for drawing specific conclusions for specific subtypes of CindU.

Background A survey in 2012 revealed marked heterogeneity in the management of antithrombotic agents in dermatologic surgery in Germany. An evidence-based guideline on this topic was published for the first time in 2014. Methods Using the same study sample, we conducted an anonymous survey on the management of antithrombotic agents and familiarity with the guideline. We reported the results as relative frequencies and compared them with those from 2012. Results We analyzed a total of 208 questionnaires (response rate: 36.6 %). A large majority of dermatologists reported performing minor procedures without discontinuing low-dose aspirin (≤ 100 mg), clopidogrel, or direct oral anticoagulants. In contrast, antithrombotic management was still heterogeneous in the context of major procedures, especially among office-based dermatologists. Overall, there was an increase in the proportion of dermatologists who managed phenprocoumon, aspirin, and clopidogrel in compliance with the guideline. For example, while 53.8 % of hospital-based dermatologists and 36.3 % of office-based dermatologists had performed large excisions on continued low-dose aspirin treatment in 2012, these figures showed an increase to 90.2 % and 57.8 %, respectively, by 2017 (phenprocoumon: from 33.8 % and 11.9 % to 63.9 % and 29.9 %, respectively; clopidogrel: from 36.9 % and 23.2 % to 63.9 % and 30.6 %, respectively). Among hospital dermatologists a large proportion was familiar with the guideline and considered it to be useful. Conclusions Our results suggest that compliance with the German guideline on the perioperative management of antithrombotics in dermatologic surgery has increased for all procedures. Despite this positive development, greater efforts are needed to improve implementation of the guideline and address barriers to its use in everyday practice.

Hintergrund Laut einer Befragung im Jahre 2012 war der Umgang mit Antithrombotika bei dermatochirurgischen Eingriffen in Deutschland sehr heterogen. 2014 wurde erstmals eine evidenzbasierte Leitlinie zu diesem Thema veroffentlicht. Methodik Es wurde eine anonyme Befragung derselben Stichprobe zum Umgang mit Antithrombotika sowie zu Kenntnissen der Leitlinie durchgefuhrt. Die Ergebnisse wurden als relative Haufigkeiten berichtet und denen aus 2012 gegenubergestellt. Ergebnisse 208 Antwortbogen wurden ausgewertet (Rucklaufquote: 36,6 %). Die grose Mehrheit der Dermatologen erklarte, kleinere Eingriffe unter Fortfuhrung der Therapie mit Phenprocoumon, niedrig dosierter Acetylsalicylsaure (≤ 100 mg) und Clopidogrel sowie mit direkten oralen Antikoagulanzien durchzufuhren. Bei groseren Eingriffen war der Umgang hingegen weiterhin heterogen, insbesondere unter niedergelassenen Dermatologen. Der Anteil der Dermatologen, die Phenprocoumon, Acetylsalicylsaure und Clopidogrel leitlinienkonform verwendeten, hat sich insgesamt vergrosert. Fuhrten 2012 beispielsweise 53,8 % der Klinikarzte bzw. 36,3 % der niedergelassenen Dermatologen eine grose Exzision unter Fortfuhrung der Therapie mit niedrig dosierter Acetylsalicylsaure durch, taten dies 2017 90,2 % bzw. 57,8 % (Phenprocoumon: 33,8 % bzw. 11,9 % auf 63,9 % bzw. 29,9 %; Clopidogrel: 36,9 % bzw. 23,2 % auf 63,9 % bzw. 30,6 %). Unter den Klinikarzten war ein hoher Anteil mit der Leitlinie vertraut und fand diese hilfreich. Schlussfolgerungen Eine Zunahme des leitlinienkonformen Verhaltens war bei allen Eingriffen zu verzeichnen. Bei groseren Eingriffen zeigte sich trotz deutlicher Verbesserung die Notwendigkeit verstarkter Anstrengungen zur Leitlinienumsetzung bzw. zur Identifizierung von Implementierungsbarrieren.

ZusammenfassungHintergrund und Zielsetzungen Mit dem Begriff „Off-Label-Use“ (zulassungsuberschreitende Anwendung) wird die Verordnung pharmazeutischer Praparate auserhalb ihrer zugelassenen Anwendungsgebiete beschrieben. Fur seltene Krankheiten sind haufig keine oder kaum zugelassene Therapiealternativen verfugbar. Die Kosten fur eine Off-Label Verordnung werden von der Gesetzlichen Krankenversicherung (GKV) nur unter bestimmten, gesetzlich geregelten Voraussetzungen ubernommen. Um Regressforderungen durch die Kostentrager zu vermeiden, kann vor Verordnung ein Antrag auf Kostenubernahme (‘Off-Label Antrag’) gestellt werden. Patienten und Methoden Es wurde eine retrospektive Auswertung von Off-Label Antragen, die im Zeitraum 2010-2012 in zwei Sprechstunden einer dermatologischen Hochschulambulanz gestellt wurden, durchgefuhrt (Autoimmun-Sprechstunde, Urtikaria-Sprechstunde). Krankenkassen, Bewilligungsraten, Grunde fur Ablehnungen und die Bearbeitungsdauer wurden ausgewertet. Ergebnisse Die Auswertung ergab, dass 56,8 % der eingeschlossenen Off-Label Antrage (n = 44) initial bewilligt wurden. Nach bis zu zweimaligem Widerspruch gegen die Ablehnung einer Kostenubernahme betrug die Bewilligungsrate insgesamt 75 %. Die Dauer zwischen Antragstellung und Bescheid durch die Kostentrager betrug 49 Tage (Median). Bei positivem Bescheid erfolgte die Therapieeinleitung 92 Tage (Median) nach Antragstellung. Schlussfolgerungen Die vorliegende Fallserie zeigt, dass die Kostentrager den beantragten Kostenubernahmen fur Off-Label Therapien im uberwiegenden Teil der betrachteten Falle zustimmten. Ob die identifizierten Probleme durch die gegenwartigen Veranderungen der gesetzlichen Rahmenbedingungen (GKV-Versorgungsstrukturgesetz, Patientenrechtegesetz) adaquat adressiert werden, sollte in einer prospektiven Studie untersucht werden.

SummaryBackground and objectives “Off-label use” is defined as the prescription of pharmaceutical products outside their approved indications. Rare diseases frequently lack “on-label” treatment options. In order to avoid reimbursement claims following the prescription of off-label drugs, physicians in Germany can – on a case-by-case basis – file an application for cost coverage with the competent health insurance prior to treatment initiation. Patients and methods We conducted a chart review for cost coverage requests submitted by two outpatient clinics at a university-affiliated dermatology department between 2010 and 2012 (clinic for autoimmune diseases and urticaria clinic). Insurance providers, acceptance rates, reasons for rejection, and processing times were analyzed. Results The analysis showed that 56.8 % of applications for off-label use (n = 44) were approved during the first round. The rate increased to 75.0 % when including approvals granted after up to two rejections. The time between initial application and the response of health insurers was 49 days (median). In case of cost coverage approval, treatments were initiated 92 days (median) after the initial request. Conclusions The present case series shows that, in the majority of cases, health insurers in Germany have agreed to reimburse the costs of proposed off-label therapies. A prospective study is required in order to evaluate whether current changes to legal regulations (GKV-Versorgungsstrukturgesetz, Patientenrechtegesetz) adequately address the problems identified.

Herpes zoster (HZ, Gurtelrose) stellt die Sekundarmanifestation einer Infektion mit dem Varizella-Zoster-Virus (VZV) dar. Eine Reaktivierung latenter VZV im Bereich des N. ophthalmicus manifestiert sich als HZ ophthalmicus (HZO). Die uberwiegend alteren und abwehrgeschwachten Patienten weisen neben charakteristischen Hautveranderungen haufig (ca. 50 %) eine Augenbeteiligung auf. Klinische Manifestationen betreffen u. a. Kornea und Konjunktiva, im spateren Verlauf kann eine Uveitis anterior oder (selten) ein akutes retinales Nekrosesyndrom auftreten. Erhebliche Einschrankungen der Lebensqualitat resultieren aus assoziierten sensorischen Phanomenen mit Parasthesien und Schmerzen. Die systemische antivirale Behandlung und eine adaquate Schmerztherapie stellen die Grundlage der Behandlung dar. Der vorliegende Beitrag stellt die Inhalte der aktuellen europaischen konsensbasierten Leitlinie zur Diagnostik und Behandlung des HZ mit besonderem Fokus auf den HZO dar.

Objectives Anogenital warts (AGW, condylomata acuminata) and intraepithelial neoplasia (IEN) do not only impact health and social well-being, they are also associated with considerable costs for the healthcare systems. Immunocompromised and HIV-positive patients carry the highest epidemiological burden of human papillomavirus (HPV) infection and comprise a population specifically susceptible to treatment failures and recurrences. This systematic review aimed at identifying and appraising the available evidence from controlled studies of interventions for the treatment of AGW and IEN in immunocompromised patients. Methods We conducted a comprehensive literature search. The Cochrane Collaboration9s tool was used to assess risk of bias in included studies. Our confidence in the (pooled) effect-estimates was evaluated according to the Grading of Recommendations Assessment, Development and Evaluation approach. All evaluations were based on data independently extracted by two review authors. Results Nine randomised controlled trials and two controlled studies were eligible, investigating external AGW, intra-anal and/or vaginal warts, and intra-anal and/or perianal IEN. The identified studies assessed imiquimod, cidofovir, fluorouracil, electrocautery, systemic interferon-α and interferon-β, and the combination of intralesional interferon-α and podophyllin. Four studies combined an ablational intervention with either imiquimod, cidofovir, intralesional or systemic interferon-α. One study investigated an experimental therapeutic vaccination (HPV 16 E7) at different concentrations. Conclusions The quality of the evidence ranged from ‘very low’ to ‘moderate’ and was limited by the often small samples. Evidence was available for the efficacy of electrocautery for intra-anal IEN, and imiquimod cream for external AGW. Some further interventions should be subjected to investigations in larger samples. No data on some interventions established for the treatment of AGW in immunocompetent patients such as podophyllotoxin, sinecatechins, laser ablation or trichloroacetate were available. Future trials should address these gaps and include relevant patient-reported outcomes such as health-related quality of life.

The present guidelines are aimed at residents and board-certified physicians in the fields of dermatology, pediatrics, pediatric dermatology and pediatric rheumatology as well as policymakers and insurance funds. They were developed by dermatologists and pediatric dermatologists in collaboration with pediatric rheumatologists using a formal consensus process (S2k). The guidelines highlight topics such as disease severity, quality of life, treatment goals as well as problems associated with off-label drug therapy in children. Trigger factors and diagnostic aspects are discussed. The primary focus is on the various topical, systemic and UV-based treatment options available and includes recommendations for use and treatment algorithms. Other aspects addressed herein include vaccinations in children and adolescents with psoriasis as well as various disease subtypes such as guttate psoriasis, diaper psoriasis, pustular psoriasis and psoriatic arthritis. Finally, we also provide recommendations for imaging studies and the diagnostic workup to rule out tuberculosis prior to initiating systemic treatment. Note: This article constitutes part 2 of the Sk2 guidelines for the treatment of psoriasis in children and adolescents. Part 1 was published in last month's issue. It contained introductory remarks and addressed aspects of diagnosis and topical treatment.

The present guidelines are aimed at residents and board-certified physicians in the fields of dermatology, pediatrics, pediatric dermatology and pediatric rheumatology as well as policymakers and insurance funds. They were developed by dermatologists and pediatric dermatologists in collaboration with pediatric rheumatologists using a formal consensus process (S2k). The guidelines highlight topics such as disease severity, quality of life, treatment goals as well as problems associated with off-label drug therapy in children. Trigger factors and diagnostic aspects are discussed. The primary focus is on the various topical, systemic and UV-based treatment options available and includes recommendations for use and treatment algorithms. Other aspects addressed herein include vaccinations in children and adolescents with psoriasis as well as various disease subtypes such as guttate psoriasis, diaper psoriasis, pustular psoriasis and psoriatic arthritis. Finally, we also provide recommendations for imaging studies and the diagnostic workup to rule out tuberculosis prior to initiating systemic treatment. Note: This article constitutes part 1 of the Sk2 guidelines for the treatment of psoriasis in children and adolescents. Part 2 will be published in the next issue. It contains chapters on UV therapy, systemic treatment, tonsillectomy and antibiotics, vaccinations, guttate psoriasis, psoriatic arthritis, complementary medicine, as well as imaging studies and diagnostic workup to rule out tuberculosis prior to systemic treatment.

This guideline is an update of the 2011 European Guideline for the Management of Anogenital Warts. It is intended to support best practice in the care of patients with anogenital warts by including evidence-based recommendations on diagnosis, treatment, follow-up and advice to patients. It is intended for use by healthcare professionals in sexual healthcare or dermato-venereology clinics in Europe but may be adapted for use in other settings where the management of anogenital warts is undertaken. As a European guideline, recommendations should be adapted according to national circumstances and healthcare systems. Despite the availability of vaccine to prevent HPV types 6 and 11, the cause of >95% anogenital warts, they remain an important and frequent health problem. The previous systematic review of randomized controlled trials for anogenital warts was updated. The changes in the present guideline include the following: Updated background information on the prevalence, natural history and transmission of human papillomavirus (HPV) infection and anogenital warts. Key recommendations for diagnosis and treatment have been graded according to the strength of the recommendation and the quality of supporting evidence. 5-fluorouracil, local interferon and photodynamic therapy have been evaluated and included as potential second-line treatment options. Evidence of the impact of HPV vaccination on the incidence of anogenital warts has been updated.

Herpes zoster (HZ, shingles) is a frequent medical condition which may severely impact the quality of life of affected patients. Different therapeutic approaches to treat acute HZ are available. The aim of this European project was the elaboration of a consensus-based guideline on the management of patients who present with HZ, considering different patient populations and different localizations. This interdisciplinary guideline aims at an improvement of the outcomes of the acute HZ management concerning disease duration, acute pain and quality of life of the affected patients and at a reduction in the incidence of postherpetic neuralgia (PHN) and other complications. The guideline development followed a structured and pre-defined process, considering the quality criteria for guidelines development as suggested by the AGREE II instrument. The steering group was responsible for the planning and the organization of the guideline development process (Division of Evidence-Based Medicine, dEBM). The expert panel was nominated by virtue of clinical expertise and/or scientific experience and included experts from the fields of dermatology, virology/infectiology, ophthalmology, otolaryngology, neurology and anaesthesiology. Recommendations for clinical practice were formally consented during the consensus conference, explicitly considering different relevant aspects. The guideline was approved by the commissioning societies after an extensive internal and external review process. In this second part of the guideline, therapeutic interventions have been evaluated. The expert panel formally consented recommendations for the treatment of patients with HZ (antiviral medication, pain management, local therapy), considering various clinical situations. Users of the guideline must carefully check whether the recommendations are appropriate for the context of intended application. In the setting of an international guideline, it is generally important to consider different national approaches and legal circumstances with regard to the regulatory approval, availability and reimbursement of diagnostic and therapeutic interventions.

Background Anogenital warts (AGWs, condylomata acuminata) are among the most common STIs and may severely impact quality of life (QoL). Available treatment options are characterised by a high proportion of non-responders and recurrences. Objective To systematically review and meta-analyse the available evidence from randomised controlled trials (RCTs) on topical treatments for AGWs considering short-term and long-term efficacy, effects on QoL and adverse events (AE). Methods A comprehensive literature search was performed in Cochrane Central Register of Controlled Trials, Embase and MEDLINE. Included studies were evaluated with the Cochrane Collaboration9s risk of bias tool. The confidence in the pooled effect estimates was evaluated according to the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach and categorised as ‘very low’, ‘low’, ‘moderate’ or ‘high’. Results Eighteen RCTs met the inclusion criteria. Regarding complete clearance (CC), imiquimod 3.75% and 5% cream, podophyllotoxin 0.5% solution and gel and polyphenon E 10% and 15% ointment were superior to placebo. Although more local AE and pain occurred in the actively treated groups, differences regarding dropouts due to AE were not statistically significant. For podophyllotoxin 0.15% cream, no placebo-controlled trials were available; however, in an active-controlled trial, it was inferior to podophyllotoxin 0.5% solution with respect to CC. No significant differences were detected between imiquimod 5% cream and podophyllotoxin 0.5% solution and between polyphenon E 10% and 15% ointment. No data on the influence on health-related QoL were available. Conclusion Our confidence in the pooled estimates (GRADE quality of the evidence) ranged from very low to high. Apart from the given results, other aspects such as availability, costs or patient preference have to be considered when making a treatment choice. Due to the limited number of direct comparisons, conclusions on the relative efficacy of the different treatment options are restricted.

People with chronic plaque psoriasis often have lesions on the scalp that are difficult to treat. This report is a summary of a Cochrane review on the efficacy and safety of topical treatments for scalp psoriasis. For quality-of-evidence assessment, we used the Grading of Recommendations Assessment, Development and Evaluation Working Group approach. Only randomized controlled trials (RCTs) were eligible for inclusion. We searched the Cochrane Skin Group Specialised Register, CENTRAL, MEDLINE, Embase and LILACS; ongoing trials; indexes of included studies and screened abstracts of six psoriasis-specific conferences up to August 2015. We included 59 RCTs, with 11 561 participants overall. Most findings were limited to short-term treatments (< 6 months). According to the clinician and patients' self-assessment, a corticosteroid-vitamin D combination (e.g. betamethasone dipropionate plus calcipotriol) and corticosteroids of high and very high potency were better than vitamin D. The two-compound combination was superior to the corticosteroid alone, but the additional benefit was small. Reporting of quality-of-life data was insufficient. The two-compound combination and corticosteroids caused fewer withdrawals due to adverse events than vitamin D. There was no difference between the two-compound combination and corticosteroid monotherapy concerning this outcome. Overall the evidence was of moderate quality. Evaluation of other topical treatments was limited. Given the comparable safety profile and only slim benefit of the two-compound combination over the corticosteroid alone, monotherapy with generic topical corticosteroids of high and very high potency may be fully acceptable for short-term therapy. More quality-of-life data and long-term assessments are needed.

In der ersten Onlineversion dieses Beitrags waren 2 Autorennamen falsch geschrieben. Wir bitten um Kenntnisnahme. Der Originalbeitrag wurde …