[The importance of guidelines in dentistry and dental education]. / Der Stellenwert von Leitlinien in der Zahnheilkunde und in der zahnmedizinischen Ausbildung.

Evidence-based treatment recommendations are gaining importance within the framework of both medical and dental quality management systems. The scientific findings, which have been evaluated critically by expert committees with regard to their methodological quality, are summarized in easy-to-understand guidelines. All guidelines are evaluated qualitatively in accordance with a balance between consensus and evidence during the drafting process regarding their stages of scientific development. The publication of guidelines and the coordination of guideline development has been carried out by the Association of the Scientific Medical Societies in Germany (AWMF) since its foundation in the 1960s. Forty-four dental guidelines are currently available, which are mostly rated at the highest level (S3) of scientific development. Therefore, recommendations for various treatment protocols are defined for both dental staff at university sites or practices and the implementation of these guidelines into the daily clinical routine is desirable. Poor acceptance and adverse resource requirements are major limitations of the establishment of guidelines with regard to the expansion of evidence-based dentistry. However, these limitations might be overcome by the introduction of basic scientific training within dental universities and increased funding of young researchers in order to ensure high treatment quality and economy in dentistry in the future. Guidelines can facilitate education by providing scientifically validated procedural templates to dental students and assisting educators in meeting the requirements of practical skills.

A memorandum of understanding has facilitated guideline development involving collaborating groups.

OBJECTIVE: Collaboration between groups can facilitate the development of high-quality guidelines. While collaboration is often desirable, misunderstandings can occur. One method to minimize misunderstandings is the pre-specification of terms of engagement in a memorandum of understanding (MOU). This study considered when an MOU may be most helpful, and which key elements should be included. STUDY DESIGN AND SETTING: An international panel of representatives from guideline groups was convened. A literature review to identify publications and other documents relevant to the establishment of MOUs between two or more guideline groups, supplemented by available source documents, was used to inform development of a draft MOU resource. This was iteratively refined until consensus was achieved. RESULTS: The level of detail in an MOU may vary based on institutional preferences and the particular collaboration. Elements within an MOU include those pertaining to: (1) scope and purpose; (2) leadership and team; (3) methods and commitment; (4) review and endorsement; and (5) publication and dissemination. CONCLUSION: Since groups may have different expectations regarding how a collaboration will unfold, an MOU may mitigate preventable misunderstandings. The result may be a higher likelihood of producing a guideline without disruption and delay.

[The G-BA innovation fund's project "Avenue-Pal" - analysis and improvement of cross-sectoral and cross-departmental interface and relocation management in palliative care]. / Das G-BA-Innovationsfonds-Projekt "Avenue-Pal" : Analyse und Verbesserung des sektor- und bereichsübergreifenden Schnittstellen- und Verlegungsmanagements in der Palliativversorgung.

BACKGROUND: About 80% of all people in Germany die in inpatient care. Around every fifth person in inpatient care is relocated to another care area in the last phase of their life. That is more than 150,000 people being relocated, often without indication. 13 risk factors were identified for these non-indicated relocations. METHOD: With the support of the AWMF, two regionally effective guidelines were developed and implemented in a maximum care hospital and a care facility. A palliative consultation service has been established in the university hospital. Comprehensive personnel and organizational development was carried out in the care facility. Different collaborations with relevant regional partners of both model institutions were systematically expanded. RESULTS AND CONCLUSIONS: The relocations could be significantly reduced despite the short duration of the project. This was also possible through the establishment of decision-making aids and digital implementation support. The results of the accompanying ethical and social research justify the procedure: There is an increase in the satisfaction of relatives and employees.

[Guidelines 2.0: systematic development of a comprehensive checklist for a successful guideline enterprise]. / Guidelines 2.0: Systematische Entwicklung einer umfassenden Checkliste für eine vertrauenswürdige Leitlinienentwicklung.

BACKGROUND: Although several tools to evaluate the credibility of health care guidelines exist, guidance on practical steps for developing guidelines is lacking. We systematically compiled a comprehensive checklist of items linked to relevant resources and tools that guideline developers could consider, without the expectation that every guideline would address each item. METHODS: We searched data sources, including manuals of international guideline developers, literature on guidelines for guidelines (with a focus on methodology reports from international and national agencies, and professional societies) and recent articles providing systematic guidance. We reviewed these sources in duplicate, extracted items for the checklist using a sensitive approach and developed overarching topics relevant to guidelines. In an iterative process, we reviewed items for duplication and omissions and involved experts in guideline development for revisions and suggestions for items to be added. RESULTS: We developed a checklist with 18 topics and 146 items and a webpage to facilitate its use by guideline developers. The topics and included items cover all stages of the guideline enterprise, from the planning and formulation of guidelines, to their implementation and evaluation. The final checklist includes links to training materials as well as resources with suggested methodology for applying the items. INTERPRETATION: The checklist will serve as a resource for guideline developers. Consideration of items on the checklist will support the development, implementation and evaluation of guidelines. We will use crowdsourcing to revise the checklist and keep it up to date.

["Deciding wisely together" - an initiative of the Association of the Scientific Medical Societies in Germany: Mission, methodology and application]. / "Gemeinsam Klug Entscheiden" ­ eine Initiative der AWMF und ihrer Fachgesellschaften: Mission, Methodik und Anwendung.

The question of how to improve healthcare quality and the need for patient empowerment and shared decision-making has been the subject of political and scientific debate for years. In addition to various quality initiatives, "top lists" summarizing selected recommendations to increase awareness of overuse, spread by means of public campaigns, has become popular on the international level - known as the "Choosing Wisely" initiative. However, the trustworthiness of "top lists", their impact on patient-relevant outcomes, their role in and integration into the context of the various pre-existing approaches to improve healthcare quality and the effects of neglecting under- and misuse are not clear. On the other hand, "top lists" may provide new opportunities to improve awareness and dissemination of carefully selected recommendations based on high-quality guidelines. Therefore, the Association of Scientific Medical Societies in Germany (AWMF) has established an ad hoc commission to design a system-specific initiative. The commission has the task to clarify goals, methods of development and concepts for implementation and evaluation, to address concerns and to build upon specific existing resources - e. g., the established quality management system for guidelines in Germany. The key goals defined by the commission include the systematization of the dialogue between healthcare practitioners and patients and the promotion of ethically founded decision-making as an answer to an increasing economic orientation of the healthcare system. To ensure the methodological quality of specific recommendations, the commission has developed a manual. To the best of our knowledge, this manual is the first detailed method paper aiming to guide developers of "Choosing Wisely" recommendations. More than 20 German medical scientific societies have already addressed the subject of "top lists".

Guidelines International Network: Principles for Disclosure of Interests and Management of Conflicts in Guidelines.

Conflicts of interest (COIs) have been defined by the American Thoracic Society as "a divergence between an individual's private interests and his or her professional obligations such that an independent observer might reasonably question whether the individual's professional actions or decisions are motivated by personal gain, such as direct financial, academic advancement, clinical revenue streams, or community standing." In the context of guideline development, the concerns are not simply about identifying and disclosing direct financial or indirect COIs. Despite this recognition, the management of COIs in guidelines is often unsatisfactory. In response to requests from its international membership and informed by existing syntheses of the evidence and policies of international organizations, the Guidelines International Network Board of Trustees developed guidance on the disclosure of interests and management of COIs. Current approaches are relatively similar throughout the guideline development community, with an increasing recognition of the importance of disclosing and managing indirect COIs. Although there are differences in detail among the approaches, the similarities allow for the formulation of 9 core principles for managing COIs. In formulating these principles, the Guidelines International Network Board of Trustees recognizes that COIs cannot be totally avoided when panel members are being chosen for certain guidelines or in certain settings; thus, the important issue is the management of COIs in a fair, judicious, transparent manner.

Evaluating Guidelines: A Review of Key Quality Criteria.

BACKGROUND: Guidelines of high methodological quality make an essential contribution to the quality assurance of medical knowledge. The detailed evaluation of guideline quality is a complex and time-consuming task. The answers to a few key questions generally suffice for an initial, rapid assessment of the quality and utility of a guideline. METHOD: We selectively searched the pertinent literature for guideline-assessing instruments and analyzed selected ones with respect to their target group, purpose, orientation, and comprehensiveness. We identified key questions from brief instruments that can be used to assess guideline quality rapidly. RESULTS: A comparison of ten instruments revealed that most were designed to provide a highly detailed assessment of guideline quality. Four recently developed instruments enable a rough and rapid assessment. They focus, in essence, on four key questions: Was the evidence analyzed systematically? Does the evidence support the recommendations? Is the goal of the guideline formulated, and are the authors named? Is the organization of the guideline easy to follow, and are the recommendations clearly signposted? CONCLUSION: Alongside the comprehensive instruments for assessing guidelines, such as DELBI and AGREE II, rapid-assessment instruments are a convenient tool for gaining a quick impression of the value of a guideline.

[Reflections on 20 years of clinical practice guideline programmes in Germany: what is their impact?]. / 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.

[Measuring quality in the German Guideline Programme in Oncology (GGPO)­methodology and implementation]. / Methodik und Umsetzung der Qualitätsmessung im Leitlinienprogramm Onkologie.

The German Guideline Programme in Oncology (GGPO) is a joint initiative between the German Cancer Society, the Association of the Scientific Medical Societies in Germany and German Cancer Aid. In accordance with the aims of the German National Cancer Plan, the GGPO supports the systematic development of high-quality guidelines. To enhance implementation and evaluation, the suggestion of performance measures (PMs) derived from guideline recommendations following a standardised methodology is obligatory within the GGPO. For this purpose, PM teams are convened representing the multidisciplinary guideline development groups including clinical experts, methodologists and patient representatives as well as those organisations that take an active part in and share responsibility for documentation and quality improvement, i.e., clinical cancer registries, certified cancer centres and, if appropriate, the institution responsible for external quality assurance according to the German Social Code (SGB). The primary selection criteria for PMs include strength of the underlying recommendation (strong, grade A), existing potential for improvement of care and measurability. The premises of data economy and standardised documentation are taken into account. Between May 2008 and July 2014, 12 guidelines with suggestions for 100 PMs have been published. The majority of the suggested performance measures is captured by the specific documentation requirements of the clinical cancer registries and certified cancer centres. This creates a solid basis for an active quality management and re-evaluation of the suggested PMs. In addition, the suspension of measures should be considered if improvement has been achieved on a broad scale and for a longer period in order to concentrate on a quality-oriented, economic documentation.

[Development of a workable mini checklist to assess guideline quality]. / Entwicklung einer praktikablen Mini-Checkliste zur Bewertung der methodischen Leitlinienqualität.

BACKGROUND: Due to lack of time, a detailed appraisal of guideline quality with complex assessment instruments such as AGREE and DELBI is not always feasible. Therefore, our aim was to develop an assessment tool in the form of a 'mini checklist' that would make it possible to quickly gauge guideline quality. METHOD: 1. A systematic literature search in MEDLINE, EMBASE and international guideline portals for available assessment tools (cut-off value for relevance: mentioned in > 50% of cases). 2. Assessment of all identified appraisal criteria in an online survey among members of the DELBI 2.0 group of experts (cut-off value for relevance: mentioned in > 75% of cases). 3. Internal Delphi technique and consensus. RESULTS: 489 requirements for the methodological quality of guidelines were extracted from 24 identified assessment instruments. These could be merged to create 49 appraisal criteria that were then evaluated by 28 of the experts approached (response rate: 43 %). Initially, 8 appraisal criteria reached both cut-off values. Seven additional appraisal criteria were adopted by consensus. According to the orientation of their content, the 15 appraisal criteria were then grouped together to form the 8 appraisal criteria that were finally included in the mini checklist. CONCLUSIONS: An assessment of guideline quality can be based on a few very important key questions, and it would be reasonable for clinicians to do so. This could promote wider acceptance of guidelines in general practice and hospitals.

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.

The diagnosis, treatment and follow-up of extracranial carotid stenosis.

BACKGROUND: Extracranial atherosclerotic lesions of the carotid bifurcation cause 10% to 20% of all cases of cerebral ischemia. Until now, there have been no comprehensive evidence- and consensus-based recommendations for the management of patients with extracranial carotid stenosis in Germany and Austria. METHODS: The literature was systematically searched for pertinent publications (1990-2011). On the basis of 182 randomized clinical trials (RCTs) and 308 systematic reviews, 30 key questions were answered and evidence-based recommendations were issued. RESULTS: The prevalence of extracranial carotid stenosis is more than 5% from age 65 onward. Men are affected twice as frequently as women. The most important diagnostic technique is Doppler- and color-coded duplex ultrasonography. RCTs have shown that the treatment of high-grade asymptomatic carotid stenosis with carotid endarterectomy (CEA) can lower the 5-year risk of stroke from 11% to 5%. Intensive conservative treatment may lower the stroke risk still further. Moreover, RCTs have shown that CEA for symptomatic 50% to 99% carotid stenosis lowers the 5-year stroke risk by 5% to 16%. Meta-analyses of the 13 available RCTs comparing carotid artery stenting (CAS) with CEA have shown that CAS is associated with a 2% to 2.5% higher risk of periprocedural stroke or death and with a 0.5% to 1% lower risk of periprocedural myocardial infarction. If no particular surgical risk factors are present, CEA is the standard treatment for high-grade carotid stenosis. CAS may be considered as an alternative to CEA if the rate of procedure-related stroke or death can be kept below 3% or 6% for asymptomatic and symptomatic stenosis, respectively. CONCLUSION: Further studies are needed so that better selection criteria can be developed for individually tailored treatment.

[Implications of publication bias on guideline development and appraisal]. / Implikationen des Publikationsbias für die Erstellung und Bewertung von Leitlinien.

The issue of selective publishing of research results is gaining more and more scientific, public and political awareness. For guideline authors, in particular, it leads to uncertainty about the interpretability of the methodological quality and clinical relevance of the available evidence and the risk of bias where their conclusions and thus guideline recommendations are concerned. The actual impact of publication bias on guideline contents appears to be low if a systematic and methodically sound approach is followed in the process of guideline development. However, the quality of the evidence on this topic is poor. Different strategies to deal with publication bias have been proposed for authors of systematic reviews but they are of limited use for guideline authors. The goal must therefore be to implement appropriate measures in order to avoid the problem ex ante. The first step would be the systematic registration of study results in publicly accessible registers.

[The German program for disease management guidelines: evaluation by use of quality indicators]. / Nationale VersorgungsLeitlinien--Evaluation durch Qualitätsindikatoren.

The Program for National Disease Management Guidelines (German DM-CPG Program) in Germany aims at the implementation of best-practice recommendations for prevention, acute care, rehabilitation and chronic care in the setting of disease management programs and integrated health-care systems. Like other guidelines, DM-CPG need to be assessed regarding their influence on structures, processes and outcomes of care. However, quality assessment in integrated health-care systems is challenging. On the one hand, a multitude of potential domains for measurement, actors and perspectives need to be considered. On the other hand, measures need to be identified that assess the function of the diagnostic and therapeutic chain in terms of cooperation and coordination of care. The article reviews methods and use of quality indicators in the context of the German DM-CPG Program.

Evidence-based (S3) guidelines for the treatment of psoriasis vulgaris.

Psoriasis vulgaris is a common and often chronic inflammatory skin disease. The incidence of psoriasis in Western industrialized countries ranges from 1 to 2%. Patients afflicted with severe psoriasis vulgaris may experience a significant reduction in quality of life. Despite the large variety of treatment options available, patient surveys have revealed lack of satisfaction with the efficacy of available treatments and a high rate of non-compliance. To optimize the treatment of psoriasis in Germany, the Deutsche Dermatologische Gesellschaft (DDG) and the Berufsverband Deutscher Dermatologen (BVDD) initiated a project to develop evidence-based guidelines for the management of psoriasis. These resulting Guidelines focus on induction therapy in cases of mild, moderate, and severe plaquetype psoriasis in adults. The Guidelines include evidence-based evaluation of the efficacy of all currently available therapeutic options in Germany. In addition, they offer detailed information on how best to administer the various treatments and give information on contraindications, adverse drug reactions, and drug interactions as well as estimates of practicability and cost. The Guidelines were developed following the recommendations of the Arbeitsgemeinschaft wissenschaftlicher medizinischer Fachgesellschaften (AWMF). The therapeutic recommendations were developed by an expert group and finalized during interdisciplinary consensus conferences.