Monika Nothacker

Ergebnisse einer S2k-Konsensuskonferenz der Deutschen Gesellschaft für Gastroenterologie, Verdauungs- und Stoffwechselerkrankungen (DGVS) gemeinsam mit der Deutschen Zöliakie-Gesellschaft (DZG) zur Zöliakie, Weizenallergie und Weizensensitivität

Korrespondenzadresse Dr. Jorg Felber Klinik fur Innere Medizin IV, Universitatsklinikum der Friedrich-Schiller-Universitat Jena Erlanger Allee 101 07740 Jena Germany Joerg.Felber@med.uni-jena.de Einleitung und Methodik ! E-1 Hintergrund Die Zoliakie ist eine lebenslange immunologisch vermittelte chronisch-entzundliche Darmerkrankung, die sich bei Personen mit genetisch-determiniertem Risiko manifestiert. Sie ist die Folge einer fehlgerichteten Immunantwort auf Gluten und verwandte Proteine, die in Weizen, Roggen, Gerste und anderen Getreidesorten vorkommen. Die Immunreaktionen fuhren zu entzundlichen Veranderungen im Dunndarm und potenziell zu systemischen Komplikationen. Die intestinale Schadigung wiederum kann zu einer Malabsorption von Nahrungsstoffen und entsprechenden Folgeerkrankungen fuhren. In den letzten Jahren sind weitere weizenabhangige Erkrankungen, die Weizenallergie und die „Nichtzoliakie-Nichtweizenallergie-Weizensensitivitat“ Gegenstand wissenschaftlicher Forschung, aber auch intensiver Diskussionen in der breiten Offentlichkeit geworden. Historisch gesehen wurde die Zoliakie lange Zeit als eine relativ seltene Erkrankung des Kindesalters betrachtet. Verbesserte Diagnosemoglichkeiten, wie z. B. die Einfuhrung der Endomysiumbzw. Transglutaminase-Antikorpernachweise, haben in den 1980erund -90er-Jahren zu einer deutlichen Zunahme der erkannten Falle gefuhrt. Zusatzlich wurde auch eine Verschiebung des Diagnosealters hin ins Erwachsenen-, teilweise ins hohere Erwachsenenalter beobachtet [1]. Daruber hinaus gibt es epidemiologische Hinweise, dass nicht nur die Anzahl der erkannten, sondern auch die Anzahl der absoluten Erkrankungsfalle zugenommen hat [1–4]. Die Zunahme der Inzidenz in den letzten Jahren weist aufUmweltfaktoren (z. B. gastrointestinale Infektionen, veranderte Ernahrungsgewohnheiten, psychosoziale Faktoren) als Risikofaktoren fur die Entstehung einer Zoliakie und die mit ihr assoziierten Autoimmunerkrankungen hin [5–9]. Inhaltsverzeichnis Seite

The Diagnosis of Fetal Alcohol Syndrome

BACKGROUND The estimated prevalence of fetal alcohol syndrome (FAS) is 8 for every 1000 live births. FAS has serious, lifelong consequences for the affected children and their families. A variety of professionals deal with persons who have FAS, including pediatricians, general practitioners, neurologists, gynecologists, psychiatrists, and psychotherapists. Early diagnosis is important so that the affected children can receive the support they need in a protective environment. METHODS A multidisciplinary guideline group has issued recommendations for the diagnosis of FAS after assessment of the available scientific evidence. This information was derived from pertinent literature (2001-2011) retrieved by a systematic search in PubMed and the Cochrane Library, along with the US-American and Canadian guidelines and additional literature retrieved by a manual search. RESULTS Of the 1383 publications retrieved by the searches, 178 were analyzed for the evidence they contained. It was concluded that the fully-developed clinical syndrome of FAS should be diagnosed on the basis of the following criteria: Patients must have at least one growth abnormality, e.g., short stature, as well as all three characteristic facial abnormalities-short palpebral fissure length, a thin upper lip, and a smooth philtrum. They must also have at least one diagnosed structural or functional abnormality of the central nervous system, e.g., microcephaly or impaired executive function. Confirmation of intrauterine exposure to alcohol is not obligatory for the diagnosis. CONCLUSION Practical, evidence-based criteria have now been established for the diagnosis of the fully-developed FAS syndrome. More research is needed in order to enable uniform, evidence-based diagnostic assessment of all fetal alcohol spectrum disorders and optimize supportive measures for the children affected by them.

20 Jahre ärztliche Leitlinien in Deutschland - was haben sie bewirkt?

Following a recommendation of the National Advisory Council for the Concerted Action in Health Care, the Association of the Scientific Medical Societies (AWMF) have promoted, supported and coordinated the development of clinical practice guidelines in Germany since 1995. The allocation of the responsibility for guideline development in the scientific societies corresponded to the principle of subsidiarity, in contrast to other countries counting on government-organised guideline programmes. To fulfil internationally consented criteria of high-quality guidelines, a quality improvement system was established relying on frequent assessments of the current state. Today, high-quality clinical practice guidelines developed by the scientific societies organised under the umbrella of the AWMF are an indispensable tool for various initiatives to improve healthcare in the German healthcare system. The next challenging goal is to establish a theory-driven framework allowing for a systematic implementation and evaluation of guidelines in Germany on the basis of existing approaches. However, success in this endeavour will require further research and funding.

Reporting standards for guideline-based performance measures.

BackgroundThe Guidelines International Network (G-I-N) aims to promote high quality clinical guideline development and implementation. Guideline-based performance measures are a key implementation tool and are widely used internationally for quality improvement, quality assurance, and pay for performance in health care. There is, however, no international consensus on best methods for guideline-based performance measures. In order to address this issue, the G-I-N Performance Measures Working Group aimed to develop a set of consensus-based reporting standards for guideline-based performance measure development and re-evaluation.MethodsMethodology publications on guideline-based performance measures were identified from a systematic literature review and analyzed. Core criteria for the development and evaluation process of guideline-based performance measures were determined and refined into draft standards with an associated rationale and description of the evidence base. In a two-round Delphi-process, the group members appraised and approved the draft standards. After the first round, the group met to discuss comments and revised the drafts accordingly.ResultsTwenty-one methodology publications were reviewed. The group reached strong consensus on nine reporting standards concerning: (1) selection of clinical guidelines, (2) extraction of clinical guideline recommendations, (3) description of the measure development process, (4) measure appraisal, (5) measure specification, (6) description of the intended use of the measure, (7) measure testing/validating, (8) measure review/re-evaluation, and (9) composition of the measure development panel.ConclusionsThese proposed international reporting standards address core components of guideline-based performance measure development and re-evaluation. They are intended to contribute to international reporting harmonization and improvement of methods for performance measures. Further research is required regarding validity, acceptability, and practicality.

Development of the Interdisciplinary Evidence-Based S3 Guideline for the Diagnosis and Treatment of Prostate Cancer: Methodological Challenges and Solutions

Evidence-based guidelines are important sources of knowledge in everyday clinical practice. In 2005, the German Society for Urology decided to develop a highquality evidence-based guideline for the early detection, diagnosis and treatment of the different clinical manifestations of prostate cancer. The guideline project started in 2005 and involved 75 experts from 10 different medical societies or medical organizations including a patient organization. The guideline was issued in September 2009 and consists of 8 chapters, 170 recommendations, and 42 statements. Due to the broad spectrum of clinical questions covered by the guideline and the high number of participating organizations and authors, the organizers faced several methodological and organizational challenges. This article describes the methods used in the development of the guideline and highlights critical points and challenges in the development process. Strategies to overcome these problems are suggested which might be beneficial in the development of new evidence-based guidelines in the future.

Hysterectomy for Benign Uterine Disease.

BACKGROUND Hysterectomy is the second most common operation in obstetrics and gynecology after Cesarean section. Until now, there has not been any German clinical guideline with recommendations concerning the indications for hysterectomy for benign uterine conditions, in consideration of the available uterus-preserving alternative treatments. METHODS We systematically searched the Medline database in 2013, in 2014, and in December 2015, focusing on aggregate evidence, and assessed the retrieved literature. The guideline recommendations were developed by a consensus process with structured independent moderation. RESULTS 30 systematic reviews and 8 randomized controlled trials were analyzed. Among the study patients treated with either hysterectomy (by any technique) or an organ-preserving alternative, at least 75-94% were satisfied with their treatment. Vaginal hysterectomy was associated with lower complication rates, shorter procedure duration, and more rapid recovery than abdominal hysterectomy and is therefore the preferred technique. If vaginal hysterectomy is not possible, a laparoscopic approach should be considered. Abdominal hysterectomy should be reserved for special indications. In 2012, the frequency of abdominal hysterectomy in Germany, Austria, and Switzerland was lower than elsewhere in the world, at 15.7% , 28.0% , and 23.9% , respectively. Uterus-preserving techniques were associated with higher reintervention rates compared to hysterectomy (11-36% vs 4-10% ). CONCLUSION The main objective is to reduce the frequency of abdominal hysterectomy. Patients should be counseled and made aware of uterus-sparing alternatives to hysterectomy so that they are able to make informed decisions.

[Implementation of clinical practice guidelines: how can we close the evidence-practice gap?].

Guidelines are intended as instruments of knowledge transfer to support decision-making by physicians, other health professionals and patients in clinical practice and thereby contribute to quality improvements in healthcare. To date they are an indispensable tool for healthcare. Their benefit for patients can only be seen in application, i.e. the implementation of guideline recommendations. For successful implementation, implementability and practicability play a crucial role and these characteristics can be influenced and should be promoted by the guideline development group. In addition, a force field analysis to identify barriers against and facilitators for the implementation of specific guideline recommendations from the perspective of physicians and patients is recommended to guide the development of an individual implementation strategy and the selection of appropriate interventions. However, implementation cannot be achieved by the guideline development group alone and a universal implementation strategy does not exist. Therefore, a process using theory, analysis, experience and shared responsibility of stakeholders in healthcare is recommended, with the aim to achieve sustainable behavioral change and improve the quality of care by guideline-oriented behavior.

Prophylactic antibiotics before cord clamping in cesarean delivery: a systematic review

The number of clinical trials investigating the optimal timing of prophylactic antibiotics in cesarean section has increased rapidly over the last few years. We conducted a systematic review to inform up‐to‐date evidence‐based guidelines to prevent postpartum infectious morbidity in the mother and rule out any safety issues related to antepartum antibiotic exposure in infants.

Bildgebende Diagnostik in der Onkologie - Evidenzanalysen des Ärztlichen Zentrums für Qualität in der Medizin (ÄZQ) für S3-Leitlinien

Within the context of the development of evidence-based oncology guidelines, the Agency for Quality in Medicine undertook evidence reviews for diagnostic imaging procedures. Systematic searches retrieved no randomised controlled trials, but only cohort studies and case series of mostly moderate quality. The identified studies provided only a restricted basis for the guideline recommendations as their validity was limited and only outcomes of diagnostic accuracy were examined. However, decision criteria for recommending diagnostic strategies significantly comprise judgements about required resources and availability of diagnostic imaging procedures. These criteria as well as patient out-comes were mostly implicit and should be explicated in future. In order to increase the relevance of evidence reviews for oncological diagnosis, high quality studies which examine resources and patient-centred outcomes for diagnostic strategies are required.

Guideline-based quality indicators—a systematic comparison of German and international clinical practice guidelines: protocol for a systematic review

BackgroundQuality indicators (QIs) are used in assessing the quality of healthcare. Evidence-based clinical practice guidelines (CPGs) are relevant sources for generating QIs. In this context, QIs are important tools to assess the implementation of guideline recommendations. However, the methodological approaches to guideline-based QI development vary considerably.In Germany, the guideline classification scheme of the AWMF (German Association of the Scientific Medical Societies) differentiates between S1-, S2k-, S2e-, and S3-CPGs depending on the methodological approach. Thus, S3-CPGs are consensus- and evidence-based CPGs and have the highest methodological standard in Germany. An analysis of the status quo of reported QIs in S3-CPGs found 35 current S3-CPGs, which report 372 different QIs.Currently, there is no gold standard for the development of guideline-based QIs. To our knowledge, no studies have investigated to what extent guideline-based QIs from different CPGs that are related to the same topic are consistent. The objective of this study is to compare guideline-based QIs and their underlying methodological approaches of German S3-CPGs with those of topic-related international CPGs.MethodsBased on the previous identified German S3-CPGs (n = 35), which report quality indicators, we will conduct systematic searches in the guidelines databases of G-I-N (Guidelines International Network) and NGC (National Guideline Clearinghouse) to identify international CPGs matching the topics of the S3-CPGs. If necessary, we will search additionally the websites of the particular CPG providers for separate documents with regard to QIs. We will include evidence-based CPGs which report QIs. Reported QIs as well as methods of development and the rationale for QIs will be extracted and compared with those of the S3-CPGs.DiscussionThis study will be part of the project “Systematic analysis of the translation of guideline recommendations into quality indicators and development of an evidence- and consensus-based standard,” supported by the German Research Association (DFG). The results of this analysis will feed into a subsequent qualitative study, which will consist of structured interviews with developers of international CPGs. Further, the results will be considered in a consensus study on standards of the translation of guideline recommendations into quality indicators in Germany.