Search

Contains fulltext : 290851.pdf (Publisher’s version ) (Open Access) BACKGROUND AND OBJECTIVES: Our objective was to develop an extension of the widely used GIN-McMaster Guideline Development Checklist and Tool for the integration of quality assurance and improvement (QAI) schemes with guideline development. METHODS: We used a mixed-methods approach incorporating evidence from a systematic review, an expert workshop and a survey of experts to iteratively create an extension of the checklist for QAI through three rounds of feedback. As a part of this process, we also refined criteria of a good guideline-based quality indicator. RESULTS: We developed a 40-item checklist extension addressing steps for the integration of QAI into guideline development across the existing 18 topics and created one new topic specific to QAI. The steps span from 'organization, budget, planning and training', to updating of QAI and guideline implementation. CONCLUSION: The tool supports integration of QAI schemes with guideline development initiatives and it will be used in the forthcoming integrated European Commission Initiative on Colorectal Cancer. Future work should evaluate this extension and QAI items requiring additional support for guideline developers and links to QAI schemes. 01 februari 2023

Item does not contain fulltext

Despite advances in the treatment of heart failure in recent years, options for patients are still limited and the disease is associated with considerable morbidity and mortality. Modulating cyclic guanosine monophosphate levels within the natriuretic peptide signaling pathway by inhibiting PDE9A has been associated with beneficial effects in preclinical heart failure models. We herein report the identification of BAY-7081, a potent, selective, and orally bioavailable PDE9A inhibitor with very good aqueous solubility starting from a high-throughput screening hit. Key aspect of the optimization was a switch in metabolism of our lead structures from glucuronidation to oxidation. The switch proved being essential for the identification of compounds with improved pharmacokinetic profiles. By studying a tool compound in a transverse aortic constriction mouse model, we were able to substantiate the relevance of PDE9A inhibition in heart diseases.

Importance: Guideline recommendations do not necessarily translate into changes in clinical practice behaviour or better patient outcomes. Objective: This systematic review aims to identify recent clinical guideline implementation strategies in oncology and to determine their effect primarily on patientrelevant outcomes and secondarily on healthcare professionals' adherence. Evidence Review: A systematic search of five electronic databases (PubMed, Web of Science, GIN, CENTRAL, CINAHL) was conducted between August and September 2021. Randomized controlled trials (RCTs) and non-randomized studies of interventions (NRSIs) assessing the effectiveness of guideline implementation strategies on patient-relevant outcomes (overall survival, quality of life, adverse events) and healthcare professionals' adherence outcomes (screening, referral, prescribing, attitudes, knowledge) in the oncological setting, were targeted. The Cochrane risk-of-bias tool and the ROBINS-I tool were used for assessing the risk of bias. Certainty of evidence was evaluated according to GRADE recommendations. Findings: Of 1058 records identified, six studies, two stepped-wedge cluster RCTs and four controlled before-and after studies, were included in the narrative synthesis. All six studies assess the effect of multi-component interventions in 2024 cancer patients and 281 healthcare professionals. None of the included studies reported overall survival and adverse events. Compared to no intervention, educational meetings combined with materials, opinion leaders, audit and feedback, and a tailored intervention or academic detailing may slightly increase referral rates. Still, the certainty in this evidence is low. The effect of multi-component interventions compared to no intervention on the quality of life of cancer patients and screening rates, prescribing behaviour, attitudes, and knowledge of healthcare professionals is very uncertain. Conclusions and Relevance: Knowledge and skill accumulation through team-oriented or online educational training and dissemination of materials embedded in multi-component interventions seem to be the most frequently researched guideline implementation strategies in the last years in oncology. This systematic review cannot conclude which implementation strategy or combination of strategies is most effective, still, it gives an overview of recent strategies used for guideline implementation in oncology and can inform policymakers, professional organisations, and institutions on the development and adoption of implementation strategies.

ZusammenfassungWie ist eine bessere Vernetzung von Medizinischen Leitlinien, Implementierung, Umsetzung und Messung des Outcomes in der onkologischer Versorgung möglich – sowohl für Erkrankte als auch für Leistungserbringer:innen ist Ziel der 2019 auf den Weg gebrachten Querschnitts-Arbeitsgruppe „Qualität und Vernetzung“. Der folgende Artikel gibt eine Übersicht über bisher erreichte Ziele in Leitlinien-Entwicklung, Qualitätsindikatoren-Entwicklung und Dokumentation in Krebsregistern.

How can we improve the interoperability of medical guidelines and the implementation and measurement of outcomes in medical health care for cancer patients as well as for care providers? This is the aim of the working group "Quality and Cross-linking". The following publication gives an overview of the targets reached in the development of guidelines together with quality indicators and documentation in cancer registries.Wie ist eine bessere Vernetzung von Medizinischen Leitlinien, Implementierung, Umsetzung und Messung des Outcomes in der onkologischer Versorgung möglich – sowohl für Erkrankte als auch für Leistungserbringer:innen ist Ziel der 2019 auf den Weg gebrachten Querschnitts-Arbeitsgruppe „Qualität und Vernetzung“. Der folgende Artikel gibt eine Übersicht über bisher erreichte Ziele in Leitlinien-Entwicklung, Qualitätsindikatoren-Entwicklung und Dokumentation in Krebsregistern.

Introduction: As part of the development of the evidence-based (S3) clinical practice guidelines for kidney and bladder cancer by the German Guideline Program in Oncology, quality indicators (QIs) were defined to measure the quality of care. Based on these guidelines and QIs, the German Cancer Society (DKG) developed two new certification systems. The aim of this article is to show the process of development and implementation of QIs in certified cancer centres. Methods: Based on strong recommendations of each guideline and an additional systematic literature review for national and international QIs, two sets of QIs were derived in a multistep standardized approach. These QIs were implemented in the centres in certification data sheets to measure their outcomes. First results of treatment years 2018 and 2019 are available. Results: The final sets include 9 QIs for kidney cancer and 12 QIs for bladder cancer. Two-thirds of the QIs were transferred to the data sheets. In 2018 and 2019, the results of all but one QI are within the plausibility limits. From 2020 on, they are replaced by stricter target values that will challenge centres to improve their outcomes. Conclusions: Guideline-derived QIs make relevant aspects of patient care measurable and consequently improvable. The first QI results are encouraging. However, the DKG certification system and the methods of measuring quality are under ongoing development. Systematic QI implementation and evaluation may help to generate broader databases and thus expand knowledge.

ZusammenfassungMalignome zählen insbesondere im höheren Alter zu den häufigsten Erkrankungen und sind in Deutschland für 25% aller Todesfälle verantwortlich. Insbesondere bei Karzinomen des Gastrointestinaltraktes ist eine Heilung oft nur durch eine ausgedehnte Operation mit signifikanter Morbidität erreichbar. Vor etwa 25 Jahren wurde erstmalig das multimodale, perioperative Fast-Track-Konzept (FT-Konzept) zur Reduktion von postoperativen Komplikationen vorgestellt und in den folgenden Jahren um weitere Bausteine erweitert. Mittlerweile gibt es Hinweise, dass bei einer Umsetzung bzw. Adhärenz der Schlüsselbausteine von über 70% neben einer Reduktion der Komplikationsrate und einer verkürzten Krankenhausverweildauer ein verbessertes onkologisches Outcome möglich sein könnte. Trotz des hohen Bekanntheitsgrades und der nachgewiesenen Vorteile des FT-Konzeptes ist die Implementierung und Aufrechterhaltung der Maßnahmen schwierig und resultiert in einer Adhärenz von nur 20 – 40%. Dies hat viele Gründe: Neben einer fehlenden interdisziplinären und interprofessionellen Kooperation sowie dem hohen zeitlichen und logistischen Aufwand bei der Implementierung und Aufrechterhaltung werden häufig limitierte personelle Ressourcen als ursächlich aufgeführt. Wir haben diese Aspekte zum Anlass genommen und mit der Ausarbeitung einer S3-Leitlinie für die perioperative Behandlung zur beschleunigten Genesung von Patienten mit gastrointestinalen Tumoren begonnen. Durch die Erstellung einer im formalen Prozess konsentierten und evidenzbasierten, multidisziplinären Leitlinie wird eine Möglichkeit eröffnet, die aufgeführten Probleme durch eine Optimierung und Standardisierung der interdisziplinären Versorgung zu lösen, was insbesondere in einem Setting mit vielen verschiedenen Fachdisziplinen und deren unterschiedlichen Interessen wichtig ist. Weiterhin wird angestrebt, durch die Standardisierung der perioperativen Prozesse den zeitlichen und logistischen Aufwand zu reduzieren. Die Darstellung der Evidenz ermöglicht es, den personellen Mehraufwand gegenüber Krankenhausträgern und Krankenkassen transparenter zu gestalten und so auch besser zu begründen. Zusätzlich erlauben es die im Rahmen der Leitlinie generierten evidenzbasierten Qualitätsindikatoren, perioperative Standards in die Zertifizierungssysteme einzubeziehen und so die Qualität der perioperativen Medizin zu messen und zu überprüfen.

Zusammenfassung Hintergrund Empfehlungen aus S3-Leitlinien (S3-LL) stellen eine wichtige Grundlage fur die Entwicklung von Qualitatsindikatoren (QI) dar. Ein einheitliches methodisches Vorgehen zur Entwicklung von QI im Kontext von S3-LL existiert in Deutschland bisher nicht. Aus diesem Grund wurde ein methodischer Standard fur die leitlinienbasierte Entwicklung von QI (QI-Standard) anhand eines strukturierten Konsensprozesses unter Einbezug der relevanten Experten- und Interessengruppen erarbeitet. Methoden Die Inhalte des QI-Standards wurden evidenzgeleitet zusammengestellt, basierend auf den Ergebnissen von Ubersichtsarbeiten und qualitativen Studien sowie unter Berucksichtigung der bereits existierenden Manuale zur leitlinienbasierten QI-Entwicklung. Fur die Abstimmung des QI-Standards wurde ein multiperspektivisches Panel mit breiter Reprasentanz von Experten- und Interessengruppen aus dem deutschen Gesundheitssystem und Expertise in Leitlinienarbeit und/oder Qualitatsmanagement nominiert. Das iterative, strukturierte Konsensverfahren beinhaltete eine zweistufige Onlinebefragung angelehnt an das Delphi-Verfahren („vorlaufige Abstimmung“) sowie eine moderierte Abschlusskonferenz, bei der diejenigen Empfehlungen in den QI-Standard aufgenommen wurden, die eine Zustimmung von >75% (Konsens-Kriterium) des Expertenpanels erhielten. Ergebnisse Der erarbeitete QI-Standard sieht als QI-Entwicklungsschritte zuerst die kriteriengestutzte Auswahl „potenzieller QI“ vor, die nach ihrer Verabschiedung als „vorlaufige QI“ in der S3-LL veroffentlicht werden und schlieslich nach erfolgreicher Testung den Status „finale QI“ erlangen. Der QI-Standard setzt sich aus insgesamt 30 Empfehlungen zusammen, die sich auf sechs Bereiche verteilen: A) Vorbereitende Arbeitsschritte fur die leitlinienbasierte Empfehlung von QI, B) Zusammensetzung der QI-Entwicklergruppe und Zusammenarbeit mit der LL-Gruppe, C) Entwicklung der potenziellen QI, D) Bewertung der potenziellen QI, E) Verabschiedung und Publikation sowie F) Pilotierung/Testung der vorlaufigen und Uberfuhrung in finale QI. Diskussion Bevor der QI-Standard bei kunftigen S3-LL-Erstellungen oder Aktualisierungen zur Implementierung empfohlen werden kann, sollte dieser in ausgewahlten S3-Leitlinienprojekten erfolgreich erprobt worden sein. Neben methodischen Anforderungen an die QI-Entwicklung muss sichergestellt sein, dass den LL-Gruppen adaquate Ressourcen fur die Umsetzung des QI-Standards zur Verfugung stehen. Schlussfolgerung Vom Einsatz des QI-Standards durch Leitliniengruppen konnen wissenschaftlich fundierte und fur die Versorgung relevante QI erwartet werden.

Introduction: In 2013, riociguat a potent and specific stimulator of the soluble guanylyl cyclase (sGC) was approved as first in class sGC stimulator which reflected a first culmination of intense research and development efforts starting in the mid 1990ies. In the meantime, it turned out that triggering cGMP production by sGC stimulators could have a broad treatment potential. In consequence, various pharmaceutical companies are still very active in identifying novel chemistry for sGC stimulators. After the first generation of sGC stimulators like riociguat or lificiguat, new compound classes with different physicochemical and kinetic profiles were identified, like the sGC stimulators vericiguat or praliciguat.Area covered: Patent literature on sGC stimulators with a focus on recent compounds of the years 2014-2019 as on claimed use and formulations of these compounds. The information was collected from publicly available data sources only (MedLine, EmBase, Chemical Abstracts, Orbit, Dolphin).Expert Opinion: With the recent advancements reported in the patent literature, sGC stimulators might be differentiated due to tissue selectivity or route of application although exhibiting the same molecular mode of action. The indication space of these compounds is potentially very broad and multiple indications in cardiovascular diseases and beyond are under investigation.

Primary vaginal carcinoma is rare. There are two pathogenetic pathways, one associated with HPV high-risk infection and another one with inactivation of p53. Vaginal Paget's disease is rare and mostly associated with vulvar disease or represents intravaginal spread of associated locoregional cancer. Diagnostic vaginal biopsies should be examined by step sections on H&E. Sentinel lymph nodes should be processed completely using ultrastaging. Morphology-based prognostic factors with good clinical evidence are tumour stage and lymph node status. Molecular markers are not currently relevant for treatment decision and prognosis.

Clinical guidelines integrate latest evidence to support clinical decision-making. As new research findings are published at an increasing rate, it would be helpful to detect when such results disagree with current guideline recommendations. In this work, we describe a software system for the automatic identification of disagreement between clinical guidelines and published research. A critical feature of the system is the extraction and cross-lingual normalization of information through natural language processing. The initial version focuses on the detection of cancer treatments in clinical trial reports that are not addressed in oncology guidelines. We evaluate the relevance of trials retrieved by our system retrospectively by comparison with historic guideline updates and also prospectively through manual evaluation by guideline experts. The system improves precision over state-of-the-art literature research strategies while maintaining near-total recall. Detailed error analysis highlights challenges for fine-grained clinical information extraction, in particular when extracting population definitions for tumor-agnostic therapies.

IntroductionThe German Guideline Program in Oncology (GGPO) has published patient versions of clinical practice guidelines for more than 10 years. However, a systematic evaluation of these is lacking. The project aims to investigate the role and applicability of patient versions by considering the perspectives of experts, patients and healthcare providers to derive recommendations for the development, dissemination and implementation of patient versions in Germany.Methods and analysisThe project comprises two main modules. In module 1, we will first obtain information on methods and approaches for the development, dissemination and implementation of patient versions by conducting systematic searches in Medline and screening the websites of guideline organisations. We will include any articles, such as methodological or empirical reports, published in German or English since 2000, that address methodological aspects related to patient versions. Further, we will conduct 20 interviews with experts from international and German organisations who are involved in the development of patient versions. In module 2, we will first conduct interviews to explore patients and healthcare providers’ perceptions of patient versions of the GGPO. For the group of patients and the group of healthcare providers, we aim to conduct 25 interviews each. Second, we will conduct focus groups, separately for breast, prostate and colon cancer. The recruitment of participants for the interviews and focus groups will primarily be done through a previous survey about patient versions in oncology. The results will be used to derive recommendations for enhancing the development, dissemination and implementation of patient versions by involving the relevant stakeholder groups.Ethics and disseminationEthical approval for the qualitative parts of the project was given by the Ethics Committee of Witten/Herdecke University (number 160/2021). Participants will be required to provide informed consent. The project findings will be published in peer-reviewed journals and presented at scientific conferences.

Background Although mammography screening is recommended in most European countries, the balance between the benefits and harms of different screening intervals is still a matter of debate. This review informed the European Commission Initiative on Breast Cancer (BC) recommendations. Methods We searched PubMed, EMBASE, and the Cochrane Library to identify RCTs, observational or modelling studies, comparing desirable (BC deaths averted, QALYs, BC stage, interval cancer) and undesirable (overdiagnosis, false positive related, radiation related) effects from annual, biennial, or triennial mammography screening in women of average risk for BC. We assessed the certainty of the evidence using the GRADE approach. Results We included one RCT, 13 observational, and 11 modelling studies. In women 50–69, annual compared to biennial screening may have small additional benefits but an important increase in false positive results; triennial compared to biennial screening may have smaller benefits while avoiding some harms. In younger women (aged 45–49), annual compared to biennial screening had a smaller gain in benefits and larger harms, showing a less favourable balance in this age group than in women 50–69. In women 70–74, there were fewer additional harms and similar benefits with shorter screening intervals. The overall certainty of the evidence for each of these comparisons was very low. Conclusions In women of average BC risk, screening intervals have different trade-offs for each age group. The balance probably favours biennial screening in women 50–69. In younger women, annual screening may have a less favourable balance, while in women aged 70–74 years longer screening intervals may be more favourable.

Background In 2017, the European Commission’s Joint Research Centre (JRC) started developing a methodological framework for a guideline-based quality assurance (QA) scheme to improve cancer quality of care. During the first phase of the work, inconsistency emerged about the use of terminology for the definition, the conceptual underpinnings and the way QA relates to health questions that are answered in guidelines. The objective of this final of three articles is to propose a conceptual framework for an integrated approach to guideline and QA development and clarify terms and definitions for key elements. This work will inform the upcoming European Commission Initiative on Colorectal Cancer (ECICC). Methods A multidisciplinary group of 23 experts from key organizations in the fields of guideline development, performance measurement and quality assurance participated in a mixed method approach including face-to-face dialogue and several rounds of virtual meetings. Informed by results of a systematic literature review that indicated absence of an existing framework and practical examples, we first identified the relations of key elements in guideline-based QA and then developed appropriate concepts and terminology to provide guidance. Results Our framework connects the three key concepts of quality indicators, performance measures and performance indicators integrated with guideline development. Quality indicators are constructs used as a guide to monitor, evaluate, and improve the quality of the structure, process and outcomes of healthcare services; performance measures are tools that quantify or describe measurable elements of practice performance; and performance indicators are quantifiable and measurable units or scores of practice, which should be guided by guideline recommendations. Conclusions The inconsistency in the way key terms of QA are used and defined has confused the field. Our conceptual framework defines the role, meaning and interactions of the key elements for improving quality in healthcare. It directly builds on the questions asked in guidelines and answered through recommendations. These findings will be applied in the forthcoming ECICC and for the future updates of ECIBC. These are large-scale integrated projects aimed at improving healthcare quality across Europe through the development of guideline-based QA schemes; this will help in implementing and improving our approach.

The discovery of soluble GC (sGC) stimulators and sGC activators provided valuable tools to elucidate NO-sGC signalling and opened novel pharmacological opportunities for cardiovascular indications and beyond. The first-in-class sGC stimulator riociguat was approved for pulmonary hypertension in 2013 and vericiguat very recently for heart failure. sGC stimulators enhance sGC activity independent of NO and also act synergistically with endogenous NO. The sGC activators specifically bind to, and activate, the oxidised haem-free form of sGC. Substantial research efforts improved on the first-generation sGC activators such as cinaciguat, culminating in the discovery of runcaciguat, currently in clinical Phase II trials for chronic kidney disease and diabetic retinopathy. Here, we highlight the discovery and development of sGC stimulators and sGC activators, their unique modes of action, their preclinical characteristics and the clinical studies. In the future, we expect to see more sGC agonists in new indications, reflecting their unique therapeutic potential.

In 2021, the 2015 German consensus guideline for the diagnosis and treatment of uterine cervical carcinoma was updated. The present article summarises the new recommendations for pathologists: the incorporation of the International Endocervical Adenocarcinoma Classification (IECC), which morphologically separates HPV-associated and non-HPV-associated adenocarcinomas, as well as the reporting of the prognostic relevant growth pattern of the adenocarcinoma of the endocervical subtype (Silva pattern). Histologically, multifocality has been defined as the presence of clearly invasive foci with a minimum distance between each focus of 0.2 cm. Because of its intratumoural heterogeneity, all carcinomas ≤ 2 cm in their largest dimension should be processed completely, and tumours 2 cm should be processed with one block per centimetre of their greatest dimension. In cases of (radical) trachelectomy/hysterectomy, the distal vaginal resection margin and all parametrial tissue should be processed completely. Sentinel lymph nodes have to be processed completely by lamellation along its long axis in 0.2 cm intervals. Immunohistochemical ultrastaging is mandatory. Staging should be performed using the 2009 FIGO classification and 2017 TNM classification. Reporting the revised 2018 FIGO classification is optional. To date, molecular markers have not been relevant for prognostication and treatment decision making.Im Jahr 2015 wurde die S3-Leitlinie für Diagnostik und Therapie des Zervixkarzinoms erstellt, die 2021 in ihrer revidierten Fassung vorliegt. Neu für die Pathologie sind die Aufnahme der International Endocervical Adenocarcinoma Classification (IECC), die zwischen HPV-assoziierten und non-HPV-assoziierten Karzinomen unterschiedet, sowie des prognostisch relevanten morphologischen Wachstumsmusters bei (HPV-assoziierten) Adenokarzinomen (sog. Silva-Pattern). Die Multifokalität beim mikroinvasiven Zervixkarzinom ist nun definiert als der Nachweis voneinander histologisch klar separierter invasiver Foci mit einem minimalen Abstand von 0,2 cm. Aufgrund einer möglichen intratumoralen Heterogenität sollen Zervixkarzinome ≤ 2 cm vollständig und Tumoren 2 cm mit einem Block pro Zentimeter größter Ausdehnung eingebettet werden. Bei der (radikalen) Trachelektomie/Hysterektomie sollen der vaginale Resektionsrand und das parametrane Gewebe vollständig eingebettet werden. Neu ist die Empfehlung zur Aufarbeitung von Sentinellymphknoten. Diese sollen entlang ihrer Längsachse in 0,2 cm Abstand lamelliert, vollständig eingebettet und mittels Ultrastaging aufgearbeitet werden. Die FIGO-Klassifikation von 2009 bzw. TNM-Kategorisierung von 2017 wird beibehalten, die Angabe der FIGO-Klassifikation 2018/19 ist optional. Molekulare Marker spielen derzeit noch keine relevante Rolle in der Prognose und zum Therapieentscheid.

BACKGROUND: Approximately half of all patients with cancer use at least one method of complementary medicine during or after tumor treatment. The substances most commonly taken are micronutrients, food supplements, and plant extracts. METHODS: This guideline is based on pertinent articles retrieved by a systematic search in the Medline, Cochrane Library, Embase, PsycInfo, and Cinahl databases. RESULTS: The evidence is offen scant for any effect of a complementary method on patient-relevant endpoints such as relief of disease symptoms, reduction of treatment side effects, or prolonged survival. Micronutrients are available in different compositions, and their dosages vary. In most studies on the use of vitamins and trace elements by cancer patients, the blood level of the substance in question was not measured before its administration, so that it remains unknown whether a deficiency was present. For this reason, no well-founded conclusion on the effects of these substances can be drawn, and their use cannot be recommended in most cases. On the other hand, there is high-level evidence supporting physical exercise by cancer patients during and after their treatment. For patients with any type of cancer, mortality is lower among those who perform more physical exercise, whether before or after they receive the diagnosis of cancer (exercise before diagnosis, hazard ratio [HR] 0.82, 95% confidence interval [CI] [0.79; 0.86]; exercise after diagnosis, HR 0.63, 95% CI [0.53; 0.75]). Physical exercise during and after treatment for cancer should, therefore, be recommended to all cancer patients. CONCLUSION: The inherent positive attribute of complementary medicine is patient empowerment: it enables patients to help themselves in an active way even while undergoing cancer treatment, as well as afterward. To avoid risks to health, patients should be instructed about unsafe methods, asked repeatedly about their use of complementary medicine, and informed specifically about potential interactions between such interventions and their cancer treatment.

The development process for clinical guidelines is influenced by factors that are relevant to the validity of a guideline but often are not captured sufficiently in the final guideline documents. PANELVIEW is an English-language tool that can be used to explore the guideline development process from the perspective of guideline group members. Our aim was to translate the PANELVIEW tool into German, taking into account national contexts and linguistic differences.The PANELVIEW tool was initially translated by a core team, then refined and approved by a group of experts in a consensus-based Delphi process. The experts were selected on the basis of their experience in guideline development covering different fields (clinical, methodological, organisational, health professional, patient perspective) and geographical regions (Germany, Austria, Switzerland). A representative of the original PANELVIEW team was also involved. The Delphi steps included an online survey, an online consensus conference and final approval by circulating the results via email. Individual items were seen as generally agreed upon if the level of agreement in the respective steps was 75 % or more.The expert group consisted of 12 persons. Of these, 11 (92 %) participated in the online survey and 10 (83 %) in the subsequent consensus conference. After the first Delphi step, sufficient agreement was achieved for 19 of 34 items (56 %). The remaining 15 items were discussed in the consensus conference and finally obtained 100 % agreement. The discussion focused on clarifying and adapting terms whose meaning was ambiguous or inadequate in the German context, which led to a deviation from the original wording in some instances.The PANELVIEW tool was translated into German by means of a Delphi process. PANELVIEW complements existing instruments for assessing the methodological quality of guidelines by capturing the perspective of the guideline group. This will enable guideline developers and organisations to identify problems in the drafting process and avoid them in future projects. User testing and validation of the German-language PANELVIEW tool are planned for the future.The German-language translation of PANELVIEW will enable guideline developers in German-speaking countries to continuously evaluate and, where necessary, improve the process and methods of guideline development.

Malignancies are among the most common diseases, especially in old age, and are responsible for 25% of all deaths in Germany. Especially carcinomas of the gastrointestinal tract can be cured in most cases only through extensive surgery with significant morbidity. About 25 years ago, the multimodal, perioperative Fast Track (FT) concept for reducing postoperative complications was introduced and additional elements were added in the following years. Meanwhile, there is growing evidence that adherence to the key elements of more than 70% leads to reduction in postoperative adverse events as well as a shorter hospital stay and could be associated with an improved oncological outcome. Despite the high level of awareness and the proven advantages of the FT concept, the implementation and maintenance of the measures is difficult and results in an adherence of only 20 - 40%. There are many reasons for this: In addition to a lack of interdisciplinary and interprofessional cooperation and the time consuming and extended logistical efforts, limited human resources are often listed as one of the main causes. We took these aspects as an opportunity and started to develop a S3 guideline for perioperative treatment to accelerate the recovery of patients with gastrointestinal malignancies. By creating a consensus- and evidence-based, multidisciplinary guideline, many of the problems listed above could probably be solved by optimising and standardising interdisciplinary care, which is particularly important in a setting with many different disciplines and their competing interests. Furthermore, the standardisation of the perioperative procedures will reduce the time and logistical effort. The presentation of the evidence allows increased transparency and justifies the additional personnel expenditure on hospital medicine and health insurance companies. In addition, the evidence-based quality indicators generated during the development of the guideline make it possible to include perioperative standards in certification systems and thus to measure and check the quality of perioperative care.Malignome zählen insbesondere im höheren Alter zu den häufigsten Erkrankungen und sind in Deutschland für 25% aller Todesfälle verantwortlich. Insbesondere bei Karzinomen des Gastrointestinaltraktes ist eine Heilung oft nur durch eine ausgedehnte Operation mit signifikanter Morbidität erreichbar. Vor etwa 25 Jahren wurde erstmalig das multimodale, perioperative Fast-Track-Konzept (FT-Konzept) zur Reduktion von postoperativen Komplikationen vorgestellt und in den folgenden Jahren um weitere Bausteine erweitert. Mittlerweile gibt es Hinweise, dass bei einer Umsetzung bzw. Adhärenz der Schlüsselbausteine von über 70% neben einer Reduktion der Komplikationsrate und einer verkürzten Krankenhausverweildauer ein verbessertes onkologisches Outcome möglich sein könnte. Trotz des hohen Bekanntheitsgrades und der nachgewiesenen Vorteile des FT-Konzeptes ist die Implementierung und Aufrechterhaltung der Maßnahmen schwierig und resultiert in einer Adhärenz von nur 20 – 40%. Dies hat viele Gründe: Neben einer fehlenden interdisziplinären und interprofessionellen Kooperation sowie dem hohen zeitlichen und logistischen Aufwand bei der Implementierung und Aufrechterhaltung werden häufig limitierte personelle Ressourcen als ursächlich aufgeführt. Wir haben diese Aspekte zum Anlass genommen und mit der Ausarbeitung einer S3-Leitlinie für die perioperative Behandlung zur beschleunigten Genesung von Patienten mit gastrointestinalen Tumoren begonnen. Durch die Erstellung einer im formalen Prozess konsentierten und evidenzbasierten, multidisziplinären Leitlinie wird eine Möglichkeit eröffnet, die aufgeführten Probleme durch eine Optimierung und Standardisierung der interdisziplinären Versorgung zu lösen, was insbesondere in einem Setting mit vielen verschiedenen Fachdisziplinen und deren unterschiedlichen Interessen wichtig ist. Weiterhin wird angestrebt, durch die Standardisierung der perioperativen Prozesse den zeitlichen und logistischen Aufwand zu reduzieren. Die Darstellung der Evidenz ermöglicht es, den personellen Mehraufwand gegenüber Krankenhausträgern und Krankenkassen transparenter zu gestalten und so auch besser zu begründen. Zusätzlich erlauben es die im Rahmen der Leitlinie generierten evidenzbasierten Qualitätsindikatoren, perioperative Standards in die Zertifizierungssysteme einzubeziehen und so die Qualität der perioperativen Medizin zu messen und zu überprüfen.

Das Zertifizierungssystem der Deutschen Krebsgesellschaft (DKG) hat in den letzten 15 Jahren zu einer fundamentalen Veranderung der onkologischen Versorgungsstrukturen in Deutschland gefuhrt. Die therapeutische Vorgehensweise in zertifizierten onkologischen Zentren basiert auf Empfehlungen, die in S3-Leitlinien auf Basis der bestverfugbaren Evidenz formuliert wurden. Aus diesen werden Qualitatsindikatoren (QIs) abgeleitet, unter denen sich auch solche finden, die gezielt Ubertherapien vermeiden sollen. Audits stellen sicher, dass diese QIs eingehalten werden. Die Analyse der Daten dazu zeigt, dass es durch diese Vorgehensweise gelungen ist, Ubertherapien effektiv zu reduzieren.

Das onkologische Leitlinienprogramm, das im Nationalen Krebsplan gefordert und gemeinsam von der Deutschen Krebshilfe, der Deutschen Krebsgesellschaft und der Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften getragen wird, wurde gerade 10 Jahre alt. Mit seiner Zielsetzung, fur alle relevanten onkologischen Entitaten Leitlinien der hochsten methodischen Entwicklungsstufe (S3) zu erstellen, war das Programm sehr erfolgreich: Uber 90 % aller Tumorentitaten sind durch das Programm abgedeckt. Fur viele Entitaten gibt es daruber hinaus auch Patientenleitlinien. Die rasante Entwicklung insbesondere im Bereich der Therapie onkologischer Erkrankungen erfordert neue Instrumente zur Aktualisierung und Kommunikation von Leitlinien, wie sie im Amendment-Verfahren, den „living guidelines“ und der Leitlinien-App umgesetzt werden. Eine weitere Herausforderung besteht in der Nutzbarmachung von Daten aus der Versorgung, insbesondere aus den zertifizierten Zentren und den Krebsregistern, fur die Leitlinien.