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This publication is the second part of the German-language S3 guideline on urticaria. It covers the management of urticaria and should be used together with Part 1 of the guideline on classification and diagnosis. This publication was prepared according to the criteria of the AWMF on the basis of the international English-language S3 guideline with special consideration of health system conditions in German-speaking countries. Chronic urticaria has a high impact on the quality of life and daily activities of patients. Therefore, if causal factors cannot be eliminated, effective symptomatic treatment is necessary. The recommended first-line treatment is to administer new generation, non-sedating H1 antihistamines. If the standard dose is not sufficiently effective, the dose should be increased up to fourfold. For patients who do not respond to this treatment, the second-line treatment in addition to antihistamines in the treatment algorithm is omalizumab and, if this treatment fails, ciclosporin. Other low-evidence therapeutic agents should only be used if all treatments in the treatment algorithm agreed upon by the guideline group fail. Both the benefit-risk profile and cost should be considered. Corticosteroids are not recommended for long-term treatment due to their inevitable severe side effects.

Die vorliegende Publikation ist der zweite Abschnitt der deutschsprachigen S3-Leitlinie Urtikaria. Sie umfasst das Management der Urtikaria und sollte gemeinsam mit Teil 1 der Leitlinie zur Klassifikation und Diagnostik genutzt werden. Diese Publikation wurde auf der Basis der internationalen englischsprachigen S3-Leitlinie unter besonderer Berücksichtigung der medizinischen Gegebenheiten im deutschsprachigen Raum entsprechend den Kriterien der AWMF erstellt. Eine chronische Urtikaria hat einen hohen Einfluss auf Lebensqualität und Leistungsfähigkeit der Patienten. Sofern kausale Faktoren nicht beseitigt werden können, ist daher eine effektive symptomatische Behandlung notwendig. Die empfohlene Therapie der ersten Wahl ist die Gabe von nicht sedierenden H1-Antihistaminika der neuen Generation. Wenn die Standarddosierung nicht ausreichend wirksam ist, sollte die Dosis bis auf das Vierfache erhöht werden. Bei Patienten, die auch auf eine solche Behandlung nicht ansprechen, sind Therapeutika der zweiten Wahl zusätzlich zu Antihistaminika im Rahmen des Therapiealgorithmus zunächst Omalizumab und, bei Versagen dieser Therapie, Ciclosporin. Weitere Therapeutika mit geringer Evidenz sollten nur bei Versagen aller Therapien des konsentierten Algorithmus verwendet werden. Dabei sollten sowohl das Nutzen-Risiko-Profil als auch die Kosten berücksichtigt werden. Kortikosteroide werden für die Langzeitbehandlung aufgrund ihrer unvermeidbaren schweren Nebenwirkungen nicht empfohlen.

Die Lebenszeitprävalenz für Urtikaria, die zu den schweren allergischen Erkrankungen zählt, liegt bei nahezu 20%. Sie schränkt nicht nur die Lebensqualität der Betroffenen ein, sondern die generelle Leistungsfähigkeit in Beruf und Alltag. Die vorliegende Publikation ist der erste Abschnitt der Leitlinie Urtikaria. Dieser Teil der Leitlinie umfasst deren Klassifikation und Diagnostik unter Einbeziehung der wesentlichen Fortschritte in der Erforschung ihrer Ursachen, auslösenden Faktoren und Pathomechanismen. Zudem befasst sie sich mit Strategien zur ökonomischen Diagnostik der verschiedenen Unterformen der Urtikaria. Dies ist entscheidend für eine individuelle, patientenorientierte Therapie, die im zweiten Teil behandelt wird. Diese deutschsprachige Leitlinie wurde auf der Basis der internationalen englischsprachigen S3-Leitlinie unter besonderer Berücksichtigung der medizinischen Gegebenheiten im deutschsprachigen Raum entsprechend den Kriterien der AWMF erstellt. Die Leitlinie beschreibt in diesem Abschnitt die Klassifikation der Urtikaria, wobei spontan auftretende Quaddeln und Schwellungen von Urtikariaformen mit induzierbaren Symptomen abgegrenzt werden. Urtikaria wird als plötzlich auftretende Quaddeln, Schwellungen oder beides definiert, ist dabei aber abzugrenzen von Zuständen bei denen Quaddeln als kurzfristiges Symptom auftreten, wie zum Beispiel bei der Anaphylaxie. Die Diagnostik stützt sich auf (eingeschränkte) Laboruntersuchungen, aber insbesondere auch die Anamnese. Darüber hinaus stehen validierte Instrumente zur Verfügung, die den Schweregrad, die Aktivität und den Verlauf erfassen.

The lifetime prevalence of urticaria, a severe allergic disease, is almost 20%. It not only limits the quality of life of those affected, but also their general performance at work and in their daily activities. This publication is the first section of the Urticaria Guideline. It covers the classification and diagnosis of urticaria, taking into account the major advances in research into its causes, triggering factors and pathomechanisms. It also addresses strategies for the efficient diagnosis of the different subtypes of urticaria. This is crucial for individual, patient-oriented treatment, which is covered in the second part of the guideline, published separately. This German-language guideline was developed according to the criteria of the AWMF on the basis of the international English-language S3 guideline with special consideration of health system characteristics in the German-speaking countries. This first part of the guideline describes the classification of urticaria, distinguishing spontaneously occurring wheals (hives) and angioedema from forms of urticaria with inducible symptoms. Urticaria is defined as sudden onset of wheals, angioedema, or both, but is to be distinguished from conditions in which wheals occur as a short-term symptom, such as anaphylaxis. The diagnosis is based on (a limited number of) laboratory tests, but especially on medical history. In addition, validated instruments are available to measure the severity, activity and course of the disease.

Das Schleimhautpemphigoid (SHP) ist eine Pemphigoid-Erkrankung, die sich überwie-gend an der Schleimhaut manifestiert. Betroffen sind vor allem die Schleimhäute von Mund, Augen, Nase und Pharynx, aber auch von Larynx, Trachea, Ösophagus sowie die Genital- und Perianal-Region. Die Ausprägung der Erkrankung ist variabel und reicht von gingivalem Erythem und einzelnen oralen Läsionen bis zu schwerwiegen-den trachealen Strikturen, die die Atmung behindern sowie konjunktivaler Vernarbung mit deutlichen Visuseinschränkungen und, nicht selten, Erblindung. Die Diagnose beruht neben dem klinisch vorherrschenden Schleimhautbefall auf der direkten Im-munfluoreszenz eines nichtläsionalen Biopsats und der Serologie. Das hauptsächliche Zielantigen ist BP180 (Kollagen XVII) und Reaktivität mit Laminin 332 ist in circa 25 % der SHP-Patienten mit einem Malignom assoziiert. Die Behandlung des SHP ist eine Herausforderung. Einerseits ist durch den Befall verschiedener Schleimhäute eine gute interdisziplinäre Zusammenarbeit der verschiedenen Fachdisziplinen gefordert, ande-rerseits stehen auf Grund der Seltenheit der Erkrankung keine randomisierten kont-rollierten klinischen Studien zur Verfügung. Ziel der Leitlinie ist es, das klinische Bild einschließlich Schweregrade und Scoring-Systeme darzustellen sowie Anleitung zu geben für die Diagnosestellung und Therapie dieser komplexen Erkrankung. Beim SHP spielt die interdisziplinäre Zusammenarbeit eine wesentliche Rolle sowie die möglichst zeitnahe Diagnosestellung und Einleitung einer adäquaten Therapie, um irreversible Schäden der Schleimhäute mit schwerwiegenden Komplikationen zu vermeiden.

Summary Mucous membrane pemphigoid (MMP) is a pemphigoid disease with predominant mucous membrane involvement. It mainly affects the mucous membranes of the mouth, eyes, nose and pharynx, but also the larynx, trachea, esophagus, genital and perianal regions. The manifestation of the disease covers a wide spectrum from gingival erythema and single oral lesions to severe tracheal strictures that obstruct breathing and conjunctival scarring with marked visual impairment and, not infrequently, blindness. In addition to a clinical picture of predominant mucosal involvement, diagnosis is based on direct immunofluorescence of a peri‐lesional biopsy and serology. The main target antigen is BP180 (collagen XVII), and reactivity with laminin 332 is associated with malignancy in approximately 25 % of MMP patients. The treatment of MMP is challenging. On the one hand, due to the involvement of different mucous membranes, good interdisciplinary cooperation is required; on the other hand, due to the rarity of the disease, no randomized controlled clinical trials are available. The aim of this guideline is to present the clinical picture, including severity and scoring systems, and to give guidance for diagnosing and treating this complex disease. In MMP, interdisciplinary cooperation plays an essential role as well as the prompt diagnosis and initiation of adequate therapy in order to avoid irreversible damage to the mucous membranes with serious complications.

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.

This update and revision of the international guideline for urticaria was developed following the methods recommended by Cochrane and the Grading of Recommendations Assessment, Development and Evaluation (GRADE) working group. It is a joint initiative of the Dermatology Section of the European Academy of Allergology and Clinical Immunology (EAACI), the Global Allergy and Asthma European Network (GALEN) and its Urticaria and Angioedema Centers of Reference and Excellence (UCAREs and ACAREs), the European Dermatology Forum (EDF; EuroGuiDerm), and the Asia Pacific Association of Allergy, Asthma and Clinical Immunology with the participation of 64 delegates of 50 national and international societies and from 31 countries. The consensus conference was held on 3 December 2020. This guideline was acknowledged and accepted by the European Union of Medical Specialists (UEMS). Urticaria is a frequent, mast-cell-driven disease that presents with wheals, angioedema, or both. The lifetime prevalence for acute urticaria is approximately 20%. Chronic urticaria, i.e. chronic spontaneous urticaria and chronic inducible urticaria, is disabling, impairs quality of life, and affects performance at work and school. This updated version of the international guideline for urticaria covers the definition and classification of urticaria and outlines expert-guided and evidence-based diagnostic and therapeutic approaches for the different subtypes of urticaria. This article is protected by copyright. All rights reserved.

Hintergrund und Zielsetzung: Wir haben in zwei Querschnittsumfragen in den Jahren 2012 und 2017 eine erhebliche Heterogenität im perioperativen Management von Antithrombotika unter Dermatologen in Deutschland festgestellt. Die erste deutsche Leitlinie zu diesem Thema wurde 2014 veröffentlicht und im Jahr 2021 aktualisiert. Wir wollten herausfinden, wie sich der Umgang mit Antithrombotika verändert hat. Methodik: Wir haben eine papierbasierte Umfrage an 1115 Dermatologen in ganz Deutschland versandt und sie zu ihrem perioperativen Management von Antithrombotika bei Operationen an der Haut sowie zu ihrer Vertrautheit mit der Leitlinie befragt. Ergebnisse: Wir erhielten Antworten von 65 stationär tätigen und 202 niedergelassenen Dermatologen. Die meisten Dermatologen gaben an, Antithrombotika bei kleineren Operationen fortzuführen. Ein nennenswerter Anteil der Dermatologen gab an, bei invasiveren Operationen die Behandlung mit Phenprocoumon perioperativ zu pausieren und mit Heparin zu überbrücken. Bei Kombinationstherapien war das Fortführen der Behandlung weniger verbreitet. Schlussfolgerungen: Der Anteil der Dermatologen in Deutschland, die angaben, Antithrombotika bei Operationen an der Haut leitlinienkonform zu managen, ist seit 2012 gestiegen. Das Fortführen von Antithrombotika bei großen Exzisionen und Wächterlymphknotenexstirpationen, der Verzicht auf die Überbrückung von Phenprocoumon mit Heparin und das perioperative Fortführen antithrombotischer Kombinationstherapien müssen jedoch weiterhin propagiert werden, insbesondere unter niedergelassenen Dermatologen.

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.

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.

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.

The German guideline for the treatment of psoriasis vulgaris was updated using GRADE methodology. The guideline is based on a systematic literature review completed on December 1, 2016, and on a formal consensus and approval process. The second part of this short version of the guideline covers the following special patient populations and treatment situations: tuberculosis screening before and during psoriasis treatment, choice of psoriasis treatment for individuals wishing to have children, as well as during pregnancy and breast-feeding, and patients with joint involvement and vaccinations. In addition, recommendations on the choice of treatment are presented for patients with the following comorbidities: hepatitis and other hepatic impairment, HIV, malignancies, neurological and psychiatric disorders, ischemic heart disease and congestive heart failure, diabetes mellitus, renal impairment and inflammatory bowel disease.

Die deutsche Psoriasis-Leitlinie zur Behandlung der Psoriasis vulgaris wurde unter Verwendung der GRADE-Methodik aktualisiert. Die Leitlinie wurde aufbauend auf einer systematischen Literaturrecherche (letzte Update-Recherche am 01.12.2016) entwickelt und in einem formalen Konsensus- und Freigabeverfahren verabschiedet. Der zweite Teil dieser Kurzfassung stellt die Empfehlungen zum Tuberkulose-Screening vor und unter Therapie, zur Therapieauswahl bei Kinderwunsch, Schwangerschaft und Stillzeit, vorliegender Gelenkbeteiligung sowie zum Umgang mit Impfungen dar. Zudem werden die Empfehlungen zur Therapieauswahl bei Komorbidität mit Hepatitis und Leberfunktionseinschränkungen, HIV, Tumorerkrankungen, Erkrankungen aus dem neurologischen und psychiatrischen Formenkreis, koronarer Herzkrankheit und Herzinsuffizienz, Diabetes mellitus, Niereninsuffizienz sowie chronisch entzündlicher Darmerkrankung dargestellt.

The German guideline for the treatment of psoriasis vulgaris was updated using GRADE methodology. The guideline is based on a systematic literature review completed on December 1, 2016, and on a formal consensus and approval process. The first section of this short version of the guideline covers systemic treatment options considered relevant by the expert panel and approved in Germany at the time of the consensus conference (acitretin, adalimumab, apremilast, cyclosporine, etanercept, fumaric acid esters, infliximab, methotrexate, secukinumab and ustekinumab). Detailed information is provided on the management and monitoring of the included treatment options.

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.

Background Commissioning is a term used in the English National Health Service (NHS) to refer to what most health systems call health planning or strategic purchasing. Drawing on research from a recent in-depth mixed methods study of a major integrated care initiative in North West London, we examine the role of commissioning in attempts to secure large-scale change within and between health and social care services to support the delivery of integrated care for people living with complex long-term conditions. Methods We analysed data collected in semi-structured interviews, surveys, workshops and non-participant observations using a thematic framework derived both deductively from the literature on commissioning and integrated care, as well as inductively from our coding and analysis of interview data. Results Our findings indicate that commissioning has significant limitations in enabling large-scale change in health services, particularly in engaging providers, supporting implementation, and attending to both its transactional and relational dimensions. Conclusions Our study highlights the consequences of giving insufficient attention to implementation, and especially the need for commissioners to enable, support and performance manage the delivery of procured services, while working closely with providers at all times. We propose a revised version of Øvretveit’s cycle of commissioning that gives greater emphasis to embedding effective implementation processes within models of commissioning large-scale change. Electronic supplementary material The online version of this article (10.1186/s12913-019-4013-5) contains supplementary material, which is available to authorized users.

Rationale and aim External review is important when developing clinical practice guidelines. Involving pharmaceutical companies may influence guideline recommendations in their favour and is therefore controversial. Our study aimed to measure stakeholder participation in the external review of the 2016 European acne guideline and assess the extent to which comments submitted by pharmaceutical companies suggested changes favouring their own products. Methods Retrospective, partially blinded case study using qualitative analysis of comments submitted during external review. Results Four stakeholder groups participated in the review: pharmaceutical company representatives (five out of five invited), professional association members (2/222), journal reviewers (n = 2), and visitors to the project website (n = 1). Of 78 comments submitted, 48 were from company representatives, 24 from journal reviewers, and six from others. Each comment suggested one change to the guideline. Of the comments submitted by companies, 41.7% related to "writing or formatting," 16.7% to "presentation of results," 12.5% to "background information for main recommendations," and 12.5% to the "strength of treatment recommendation". In 54.2% (26/48) of these comments, a change was suggested that put the companies' own products in a more positive light. Five of these changes were implemented by the guideline authors in the way suggested by the company representatives. Conclusion Participation of professional societies, patients, and the general public in the external review of the 2016 European acne guideline was unacceptably low. This is in concordance with reports of low participation of these groups in other European dermatology guidelines. While involving the pharmaceutical industry in the review substantially increased the number of comments received, many of these sought changes that would have put companies' own products in a more favourable light. Our findings underscore the need to manage reviewer comments in a robust and transparent fashion. Solutions to encourage participation of all relevant stakeholders are needed.

The German guideline for the treatment of psoriasis vulgaris was updated using GRADE methodology. The guideline is based on a systematic literature review completed on December 1, 2016, and on a formal consensus and approval process. The second part of this short version of the guideline covers the following special patient populations and treatment situations: tuberculosis screening before and during psoriasis treatment, choice of psoriasis treatment for individuals wishing to have children, as well as during pregnancy and breast-feeding, and patients with joint involvement and vaccinations. In addition, recommendations on the choice of treatment are presented for patients with the following comorbidities: hepatitis and other hepatic impairment, HIV, malignancies, neurological and psychiatric disorders, ischemic heart disease and congestive heart failure, diabetes mellitus, renal impairment and inflammatory bowel disease.

Die deutsche Psoriasis‐Leitlinie zur Behandlung der Psoriasis vulgaris wurde unter Verwendung der GRADE‐Methodik aktualisiert. Die Leitlinie wurde aufbauend auf einer systematischen Literaturrecherche (letzte Update‐Recherche am 01.12.2016) entwickelt und in einem formalen Konsensus‐ und Freigabeverfahren verabschiedet. Der erste Teil dieser Kurzfassung stellt die Empfehlungen zu den von der Expertengruppe als relevant befundenen und zum Zeitpunkt der Konsensuskonferenz zugelassenen Therapien dar (Acitretin, Adalimumab, Apremilast, Ciclosporin, Etanercept, Fumarsaureester, Infliximab, Methotrexat, Secukinumab, Ustekinumab). Die Leitlinie gibt Hinweise zu Management und Uberwachung der eingeschlossenen Therapieoptionen.

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.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.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.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.

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 veröffentlicht.Es wurde eine anonyme Befragung derselben Stichprobe zum Umgang mit Antithrombotika sowie zu Kenntnissen der Leitlinie durchgeführt. Die Ergebnisse wurden als relative Häufigkeiten berichtet und denen aus 2012 gegenübergestellt.208 Antwortbögen wurden ausgewertet (Rücklaufquote: 36,6 %). Die große Mehrheit der Dermatologen erklärte, kleinere Eingriffe unter Fortführung der Therapie mit Phenprocoumon, niedrig dosierter Acetylsalicylsäure (≤ 100 mg) und Clopidogrel sowie mit direkten oralen Antikoagulanzien durchzuführen. Bei größeren Eingriffen war der Umgang hingegen weiterhin heterogen, insbesondere unter niedergelassenen Dermatologen. Der Anteil der Dermatologen, die Phenprocoumon, Acetylsalicylsäure und Clopidogrel leitlinienkonform verwendeten, hat sich insgesamt vergrößert. Führten 2012 beispielsweise 53,8 % der Klinikärzte bzw. 36,3 % der niedergelassenen Dermatologen eine große Exzision unter Fortführung der Therapie mit niedrig dosierter Acetylsalicylsäure 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 Klinikärzten war ein hoher Anteil mit der Leitlinie vertraut und fand diese hilfreich.Eine Zunahme des leitlinienkonformen Verhaltens war bei allen Eingriffen zu verzeichnen. Bei größeren Eingriffen zeigte sich trotz deutlicher Verbesserung die Notwendigkeit verstärkter Anstrengungen zur Leitlinienumsetzung bzw. zur Identifizierung von Implementierungsbarrieren.

BackgroundInterferons are natural messenger proteins that are used to treat various disease entities. Due to their immunomodulating, antiviral and antiproliferative effects, the systemic administration of interferons after ablative treatment for anogenital warts (AGWs) has been advocated to increase clearance and decrease recurrence rates. However, studies investigating the efficacy of adjuvant systemic interferon have yielded inconsistent results. The objective of this systematic review and meta-analysis was to comprehensively assess and evaluate the available evidence from randomised controlled trials.MethodsA literature search was conducted in Cochrane Central Register of Controlled Trials, Embase and MEDLINE. Available data were classified according to the interferon type and dosage. Pooled effect estimates were calculated for predefined outcomes. The Cochrane Collaboration’s risk of bias tool was used to assess the included trials and the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach to evaluate our confidence in the effect estimates.ResultsTwelve trials were identified that met the inclusion criteria and assessed immunocompetent patients with external AGW. Compared with placebo, adjuvant alpha-, beta- and gamma-interferon were generally not significantly superior in terms of complete clearance over the short, intermediate or long term, nor with regard to intermediate- or long-term recurrence. However, the low-dose subgroup of adjuvant alpha-interferon was significantly superior compared with placebo regarding intermediate-term complete clearance and recurrence. Further data were available for the comparison of different dosages of alpha- and beta-interferon and for comparisons of the three interferon types. No significant differences were seen in these comparisons regarding efficacy. Data on quality of life were not available.ConclusionsThe GRADE quality of the evidence ranged from ‘very low’ to ‘high’. The significantly higher efficacy of low-dose alpha-interferon compared with placebo was based on a single trial, and our confidence in the effect estimates rated as ‘low’. Overall, we found no reliable evidence favouring the systemic use of interferon after ablative treatment of AGW.

Introduction: Delivering more integrated care has long been a priority in England. Both care quality and cost effectiveness have been seen to require effective collaboration between local government and the NHS. Despite repeated national programmes and some localised progress, success has never been universalised. The recent Coalition Government launched several initiatives to enable integrated care to ‘become the standard model for everyone with health and care needs’ (Hunt and Lamb 2013). Among these initiatives was the establishment of ‘integration pioneers’ in the ‘most ambitious and visionary areas’ to ‘help to get the ball rolling’ and share ‘every lesson learned’. In return, central government promised support to remove national barriers to integration. The Whole Systems Integrated Care (WSIC) programme in North West London (NWL) was the largest pioneer in terms of population (2.4million) and partners (31 agencies). This paper reports on an initial evaluation conducted by its authors between January 2014 and May 2015. Theory/Methods: A primarily qualitative evaluation with a strong formative element was commissioned to provide ongoing feedback and independent assessments of: - How WSIC was designed; - Stakeholder involvement; - Early implementation of pilot schemes; - How far WSIC appeared on track to meet its objectives. Data were collected through documentary analysis, non-participant observation, 73 interviews, workshops, a focus group, and two web-based surveys. The interviews and focus group were recorded, transcribed and analysed using NVivo. Emerging findings were fed back in round table sessions to help structure reflections on progress. Results: - WSIC built on lessons identified by an earlier evaluation in NWL (Curry et al 2013). It was ambitious and well resourced from funds pooled by the eight CCGs: £14.9m over the first two years of which most (£7.9m) was spent on management consultancy to address barriers to integration and lead a co-design. - A programme team developed a timetabled process for integrated care to become ‘business as usual’ from April 2015. A key principle was to save time and resources by addressing problems once rather than in each of eight local areas. - The initial co-design phase was completed largely on time. However, the programme was more than a year behind schedule when our evaluation ended and had yet to deliver significant service change. Only two of eight early adopter projects had begun operations by April 2015. - By late April 2015, the WSIC programme was seen to be approaching a ‘tipping point’. Changes in the programme’s leadership created concerns about its strategic management capacity and the need to demonstrate its ability to deliver change was considered increasingly urgent. Discussion: - A complex mix of enablers and barriers with local and national origins was considered responsible for the relative success of the design stage and the much slower progress subsequently. Co-design, inclusivity (especially of lay partners), an openness to learning, a clear, timetabled route map, together with roles of the programme management team and its resources were seen as valuable enablers. - However, the transition from planning to implementation and roll out of Early Adopters proved more difficult than anticipated. While some of the barriers could be addressed locally, others ultimately required action by central government. Among the former, the programme struggled to find the balance between, for example: collective leadership and local autonomy; integrated commissioning and integrated provision; NHS leadership and local authority engagement; local variation and programme-wide consistency; investment in design and support for ongoing implementation and change. - Managing such tensions is integral to such a programme and requires capabilities in systems leadership. NHS leaders have relatively little training or experience in managing systems as opposed to organisations.(Timmins, 2015). - National barriers slowing progress included difficulties in: securing data-sharing and information governance; developing payment and accountability systems aligned with integrated care objectives; enabling local government to be more equal partners especially when their finances were cut more heavily than the NHS; maintaining acute provider viability while reducing hospital admissions; balancing completion and collaboration. - Many of these barriers were identified before the Pioneer initiative but, despite the national commitment to remove them, little progress has yet been made. Conclusion: The distinction between local and national barriers and facilitators is an analytical one. In practice, they are interdependent. The NWL case shows the importance of developing effective local systems leadership capabilities within a national framework structured to support such leadership. It also highlights the need to ensure integration barriers are removed during the design stage and that the transition from design to delivery is planned and supported.

Aim To investigate the spatial distribution of avoidable cancer mortality (ACM) rates in Germany and to identify small areas with exceptionally high rates using districts (Landkreise/Kreise and kreisfreie Städte) as a unit of analysis. Avoidable cancer mortality reflects deaths from cancer that should not occur in the presence of effective and timely health care. Methods Age-standardised, average ACM rates were calculated for the period from 2000 through 2004 for each of the 439 districts in Germany using unit-record mortality data. The spatial distribution of ACM was subsequently analysed using country maps, interval estimates and regression analysis. Data on mortality and age distribution were obtained from the German Federal Statistical Office (DESTATIS) and the Federal Office for Building and Regional Planning (INKAR). Results We found that in women under 70 years, the highest ACM rates were seen for cancer of the breast and for cancer of the trachea, bronchus and lung, whereas in men under 70 years, the highest ACM rates were seen for cancer of the trachea, bronchus and lung, and for cancer of the colon, rectosigmoid junction, rectum, anus and anal canal. The statistically lowest mean ACM rates could be found in the south of Germany for men and women. Although the mean ACM rates in men in former East Germany were significantly higher than elsewhere in the country, they were not substantially higher than those in the west and northwest. The mean ACM rates in women were even lower in the east than in the northwest and west. Conclusion The spatial distribution of ACM rates in women in Germany showed a north-south gradient rather than the east-west gradient that often appears or, for sociohistorical reasons, is even assumed in the German context. When applying measures of ACM, we suggest using districts with statistically lower ACM rates than the nationwide average as a benchmark for the maximum number of excess deaths that should be considered preventable, whether within the current German context or beyond.

Objectives This study aims to analyze mechanisms for facilitating the uptake of new medical devices in the German system of hospital reimbursement, focusing on the example of coronary stents, including (1) trends in their coding, (2) associated diagnosis-related group (DRG) payments, (3) their integration in the German DRG (G-DRG) system, and (4) their diffusion within the inpatient sector. Methods Published and gray literature provide the basis for analyzing the system of hospital reimbursement. Data on coronary stents were obtained from various regulatory and government bodies and examined in a longitudinal fashion. Results Although German Procedure Classification (Operationen- und Prozedurenschlussel; OPS) codes were created for a range of stent technologies between 2004 and 2009, the regular system of G-DRG reimbursement does not distinguish between different stents by means of unique DRGs. Instead, supplementary payments or extrabudgetary payments are used to ensure that newer technologies are reimbursed adequately. The limitations of extrabudgetary payments restrict the use of some devices to a small proportion of patients. Data on the diffusion of different stents show that factors other than the reimbursement regime likely also play a role in the frequency with which certain technologies are used. Bare metal stents currently account for most stent implantation procedures in Germany, followed by drug-eluting stents. Conclusion The current system of G-DRG reimbursement and of extrabudgetary payments ensures that even the most recently developed technologies can be used in the German inpatient sector. Nevertheless, certain technologies may not be reaching the broad patient population.

Most new medical devices in Germany are first introduced in the inpatient sector. The key hurdles to marketing them are thus to ensure their inclusion in the German Diagnosis-Related Group (G-DRG) system and to bridge the financial gap in the interim. In 2005, a system of extrabudgetary payments was introduced to bridge this gap and to expedite the inclusion of new technologies in the G-DRG system. The present study aims (1) to describe prototypical regulatory pathways for including new medical devices and other technologies in the G-DRG system and (2) to analyse real-world data on applications for extrabudgetary reimbursement to determine the pathways these technologies followed between 2005 and 2009. The findings show that the technologies did indeed follow the prototypical pathways and that patients' access to them has been improved by the system of extrabudgetary payments. Some technologies, however, have still not been fully included in the G-DRG system, even after four years. Moreover, impr...

Dieser Beitrag ist mit Zustimmung des Rechteinhabers aufgrund einer (DFG geförderten) Allianz- bzw. Nationallizenz frei zugänglich. This publication is with permission of the rights owner freely accessible due to an Alliance licence and a national licence (funded by the DFG, German Research Foundation) respectively.

This study aims to analyze mechanisms for facilitating the uptake of new medical devices in the German system of hospital reimbursement, focusing on the example of coronary stents, including (1) trends in their coding, (2) associated diagnosis-related group (DRG) payments, (3) their integration in the German DRG (G-DRG) system, and (4) their diffusion within the inpatient sector.Published and gray literature provide the basis for analyzing the system of hospital reimbursement. Data on coronary stents were obtained from various regulatory and government bodies and examined in a longitudinal fashion.Although German Procedure Classification (Operationen- und Prozedurenschlüssel; OPS) codes were created for a range of stent technologies between 2004 and 2009, the regular system of G-DRG reimbursement does not distinguish between different stents by means of unique DRGs. Instead, supplementary payments or extrabudgetary payments are used to ensure that newer technologies are reimbursed adequately. The limitations of extrabudgetary payments restrict the use of some devices to a small proportion of patients. Data on the diffusion of different stents show that factors other than the reimbursement regime likely also play a role in the frequency with which certain technologies are used. Bare metal stents currently account for most stent implantation procedures in Germany, followed by drug-eluting stents.The current system of G-DRG reimbursement and of extrabudgetary payments ensures that even the most recently developed technologies can be used in the German inpatient sector. Nevertheless, certain technologies may not be reaching the broad patient population.

The original article, unfortunately, contained a mistake. The third sentence under “Introduction” that reads “Taken together, approximately 46 % of all deaths in Germany that year could be attributed to some form of malignant neoplasm (Robert Koch Institute and Association of Population-based Cancer Registries in Germany 2010)” should be corrected to “Taken together, approximately 26 % of all deaths in Germany that year could be attributed to some form of malignant neoplasm (Robert Koch Institute and Association of Population-based Cancer Registries in Germany 2010).”