[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.

Bispidine Chelators for Radiopharmaceutical Applications with Lanthanide, Actinide, and Main Group Metal Ions.

Octadentate and specifically nonadentate ligands with a bispidine scaffold (3,7-diazabicyclo[3.3.1]nonane) are known to be efficiently coordinated to a range of metal ions of interest in radiopharmaceutical chemistry and lead to exceedingly stable and inert complexes. Nonadentate bispidine L2 (with a tridentate bipyridine acetate appended to N3 and a picolinate at N7) has been shown before to be an ideal chelator for 111In3+, 177Lu3+, and 225Ac3+, nuclides of interest for diagnosis and therapy, and a proof-of-principle study with an SSTR2-specific octreotate has shown potential for theranostic applications. We now have extended these studies in two directions. First, we present ligand derivative L3, in which the bipyridine acetate is substituted with terpyridine, a softer donor for metal ions with a preference for more covalency. L3 did not fulfill the hopes because complexation is much less efficient. While for Bi3+ and Pb2+ the ligand is an excellent chelator with properties similar to those of L2, Lu3+ and La3+ show very slow and inefficient complexation with L3 in contrast to L2, and 225Ac3+ is not fully coordinated, even at an increased temperature (92% radiochemical yield at 80 °C, 60 min, [L3] = 10-4 M). These observations have led to a hypothesis for the complexation pathway that is in line with all of the experimental data and supported by a preliminary density functional theory analysis, which is important for the design of further optimized bispidine chelators. Second, the coordination chemistry of L2 has been extended to Bi3+, La3+, and Pb2+, including solid state and solution structural work, complex stabilities, radiolabeling, and radiostability studies. All complexes of this ligand (La3+, Ac3+, Lu3+, Bi3+, In3+, and Pb2+), including nuclides for targeted α therapy (TAT), single-photon emission computed tomography, and positron emission tomography, are formed efficiently under physiological conditions, i.e., suitable for the labeling of delicate biological vectors such as antibodies, and the complexes are very stable and inert. Importantly, for TAT with 225Ac, the daughter nuclides 213Bi and 209Pb also form stable complexes, and this is important for reducing damage to healthy tissue.

The GIN-McMaster guideline tool extension for the integration of quality improvement and quality assurance in guidelines: a description of the methods for its development.

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.

The German Guidelines for the treatment of anxiety disorders: first revision.

Starting in 2019, the 2014 German Guidelines for Anxiety Disorders (Bandelow et al. Eur Arch Psychiatry Clin Neurosci 265:363-373, 2015) have been revised by a consensus group consisting of 35 experts representing the 29 leading German specialist societies and patient self-help organizations. While the first version of the guideline was based on 403 randomized controlled studies (RCTs), 92 additional RCTs have been included in this revision. According to the consensus committee, anxiety disorders should be treated with psychotherapy, pharmacological drugs, or their combination. Cognitive behavioral therapy (CBT) was regarded as the psychological treatment with the highest level of evidence. Psychodynamic therapy (PDT) was recommended when CBT was not effective or unavailable or when PDT was preferred by the patient informed about more effective alternatives. Selective serotonin reuptake inhibitors (SSRIs) and serotonin-noradrenaline reuptake inhibitors (SNRIs) are recommended as first-line drugs for anxiety disorders. Medications should be continued for 6-12 months after remission. When either medications or psychotherapy were not effective, treatment should be switched to the other approach or to their combination. For patients non-responsive to standard treatments, a number of alternative strategies have been suggested. An individual treatment plan should consider efficacy, side effects, costs and the preference of the patient. Changes in the revision include recommendations regarding virtual reality exposure therapy, Internet interventions and systemic therapy. The recommendations are not only applicable for Germany but may also be helpful for developing treatment plans in all other countries.

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.

[Methodological Standard for the Development of Quality Indicators within Clinical Practice Guidelines - Results of a structured consensus process]. / Methodischer Standard für die Entwicklung von Qualitätsindikatoren im Rahmen von S3-Leitlinien ­ Ergebnisse einer strukturierten Konsensfindung.

BACKGROUND: Recommendations of evidence- and formally consensus-based clinical practice guidelines (CPGs) represent a valuable source of quality indicators (QIs). Nevertheless, a standardized methodological procedure for developing QIs in the context of CPGs does not yet exist in Germany for all CPGs. For this reason, a methodological standard for the guideline-based development of QIs (QI Standard) was developed based on a structured consensus process involving multiple key stakeholders. METHODS: The proposed content of the QI Standard was derived from evidence, drawing upon results of reviews and qualitative studies, and considered German manuals for guideline-based QI development of two guideline programs. A multi-perspective consensus panel, broadly representing key stakeholders from the German healthcare system with expertise in CPGs and/or quality management, was nominated to vote on recommendations for guideline-based development of QIs. The iterative, structured consensus process included a two-stage online survey based on the Delphi method ("preliminary voting") and a moderated final stakeholder conference where all those recommendations were definitely included in the QI Standard that received approval of more than 75 % (consensus criterion) of the consensus panel. RESULTS: Based on the agreed QI Standard, the QI development process starts with a criteria-based selection of "potential" QIs which - in case of adoption - are published in CPGs as "preliminary" QIs and can achieve the status "final" after successful testing. The QI Standard is composed of a total of 30 recommendations, which are allocated to six areas: A) preparatory work steps for the guideline-based recommendation of QIs, B) QI development group and cooperation with the CPG group, C) development of potential QIs, D) critical appraisal of potential QIs, E) formal adoption and publication as well as F) piloting/testing of preliminary QIs and conversion into final QIs. DISCUSSION: Before the QI Standard can be recommended for implementation in future CPGs, it should have been successfully tested in selected German CPG projects. In addition to methodological requirements for the QI development, it must be ensured that guideline groups have adequate resources for the implementation of the QI Standard. CONCLUSION: By using the QI Standard, scientifically sound and healthcare-relevant QIs can be expected.

International experiences in the development and implementation of guideline-based quality indicators: a qualitative study.

OBJECTIVES: Evidence-based clinical guidelines play an important role in healthcare and can be a valuable source for quality indicators (QIs). However, the link between guidelines and QI is often neglected and methodological standards for the development of guideline-based QI are still lacking. The aim of this qualitative study was to get insights into experiences of international authors with developing and implementing guideline-based QI. SETTING: We conducted semistructured interviews via phone or skype (September 2017-February 2018) with guideline authors developing guideline-based QI. PARTICIPANTS: 15 interview participants from eight organisations in six European and North American countries. METHODS: Organisations were selected using purposive sampling with a maximum variation of healthcare settings. From each organisation a clinician and a methodologist were asked to participate. An interview guide was developed based on the QI development steps according to the 'Reporting standards for guideline-based performance measures' by the Guidelines International Network. Interviews were analysed using qualitative content analysis with deductive and inductive categories. RESULTS: Interviewees deemed a programmatic approach, involvement of representative stakeholders with clinical and methodological knowledge and the connection to existing quality improvement strategies important factors for developing QI parallel to or after guideline development. Methodological training of the developing team and a shared understanding of the QI purpose were further seen conducive. Patient participation and direct patient relevance were inconsistently considered important, whereas a strong evidence base was seen essential. To assess measurement characteristics interviewees favoured piloting, but often missed implementation. Lack of measurability is still experienced a serious limitation, especially for qualitative aspects and individualised care. CONCLUSION: Our results suggest that developing guideline-based QI can succeed either parallel to or following the guideline process with careful planning and instruction. Strategic partnerships seem key for implementation. Patient participation and relevance, measurement of qualitative aspects and piloting are areas for further development. TRIAL REGISTRATION NUMBER: German Clinical Trials Registry (DRKS00013006).

Evaluation of evidence grades in psychiatry and psychotherapy guidelines.

BACKGROUND: Information regarding the distribution of evidence grades in psychiatry and psychotherapy guidelines is lacking. Based on the German evidence- and consensus- based (S3) psychiatry and psychotherapy and the Scottish Intercollegiate Guidelines Network (SIGN) treatment guidelines, we aimed to specify how guideline recommendations are composed and to what extent recommendations are evidence-based. METHODS: Data was collected from all published evidence- and consensus-based S3-classified psychiatry and psychotherapy guidelines. As control conditions, data from German neurology S3-classified guidelines as well as data from recent SIGN guidelines of mental health were extracted. Two investigators reviewed the selected guidelines independently, extracted and analysed the numbers and levels of recommendations. RESULTS: On average, 45.1% of all recommendations are not based on strong scientific evidence in German guidelines of psychiatry and psychotherapy. A related pattern can be confirmed for SIGN guidelines, where the mean average of recommendations with lacking evidence is 33.9%. By contrast, in the German guidelines of neurology the average of such recommendations is 16.5%. A total of 24.5% of all recommendations in the guidelines of psychiatry and psychotherapy are classified as level A recommendations, compared to 31.6% in the field of neurology and 31.1% in the SIGN guidelines. Related patterns were observed for B and 0 level recommendations. CONCLUSION: Guidelines should be practical tools to simplify the decision-making process based on scientific evidence. Up to 45% of all recommendations in the investigated guidelines of psychiatry and psychotherapy are not based on strong scientific evidence. The reasons for this high number remain unclear. Possibly, only a limited number of studies answer clinically relevant questions. Our findings thereby question whether guidelines should include non-evidence-based recommendations to be methodologically stringent and whether specific processes to develop expert-opinion statements must be implemented.

[Medicine and Economy: Measures for a Science Based, Patient-Centred and Resource Conscious Care. The Association of Scientific Medical Societies' (AWMF) Strategy Paper]. / Medizin und Ökonomie: Maßnahmen für eine wissenschaftlich begründete, patientenzentrierte und ressourcenbewusste Versorgung. Ein Strategiepapier der Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften (AWMF).

The AWMF and its medical societies perceive an increasing dominance of economic targets in the hospital health care sector, leading to impairment of patient care. While resource use in health care should be appropriate, efficient and fairly allocated, "economization" creates a burdensome situation for physicians, nurses and other health care professionals.The AMWF and the medical societies studied causes and developed measures for a scientific, patient-centred and resource-conscious medical care. Disincentives due to the remuneration system, number and equipment of hospitals resp. specialist departments and their basic funding need to be overcome. Proposed actions relate to the patient-doctor-level, the management level of hospitals and the level of planning and financing hospitals including compensation of hospital care. To place patients and their health in the forefront again, joint efforts of all stakeholders in health care are needed.

Interdisciplinary Screening, Diagnosis, Therapy and Follow-up of Breast Cancer. Guideline of the DGGG and the DKG (S3-Level, AWMF Registry Number 032/045OL, December 2017) - Part 2 with Recommendations for the Therapy of Primary, Recurrent and Advanced Breast Cancer.

Purpose The aim of this official guideline coordinated and published by the German Society for Gynecology and Obstetrics (DGGG) and the German Cancer Society (DKG) was to optimize the screening, diagnosis, therapy and follow-up care of breast cancer. Method The process of updating the S3 guideline published in 2012 was based on the adaptation of identified source guidelines. They were combined with reviews of evidence compiled using PICO (Patients/Interventions/Control/Outcome) questions and with the results of a systematic search of literature databases followed by the selection and evaluation of the identified literature. The interdisciplinary working groups took the identified materials as their starting point and used them to develop suggestions for recommendations and statements, which were then modified and graded in a structured consensus process procedure. Recommendations Part 2 of this short version of the guideline presents recommendations for the therapy of primary, recurrent and metastatic breast cancer. Loco-regional therapies are de-escalated in the current guideline. In addition to reducing the safety margins for surgical procedures, the guideline also recommends reducing the radicality of axillary surgery. The choice and extent of systemic therapy depends on the respective tumor biology. New substances are becoming available, particularly to treat metastatic breast cancer.

Interdisciplinary Screening, Diagnosis, Therapy and Follow-up of Breast Cancer. Guideline of the DGGG and the DKG (S3-Level, AWMF Registry Number 032/045OL, December 2017) - Part 1 with Recommendations for the Screening, Diagnosis and Therapy of Breast Cancer.

Purpose The aim of this official guideline coordinated and published by the German Society for Gynecology and Obstetrics (DGGG) and the German Cancer Society (DKG) was to optimize the screening, diagnosis, therapy and follow-up care of breast cancer. Methods The process of updating the S3 guideline dating from 2012 was based on the adaptation of identified source guidelines which were combined with reviews of evidence compiled using PICO (Patients/Interventions/Control/Outcome) questions and the results of a systematic search of literature databases and the selection and evaluation of the identified literature. The interdisciplinary working groups took the identified materials as their starting point to develop recommendations and statements which were modified and graded in a structured consensus procedure. Recommendations Part 1 of this short version of the guideline presents recommendations for the screening, diagnosis and follow-up care of breast cancer. The importance of mammography for screening is confirmed in this updated version of the guideline and forms the basis for all screening. In addition to the conventional methods used to diagnose breast cancer, computed tomography (CT) is recommended for staging in women with a higher risk of recurrence. The follow-up concept includes suggested intervals between physical, ultrasound and mammography examinations, additional high-tech diagnostic procedures, and the determination of tumor markers for the evaluation of metastatic disease.

[Update of the German S3 guideline on atraumatic femoral head necrosis in adults]. / Update S3-Leitlinie Atraumatische Femurkopfnekrose des Erwachsenen.

The update of the German S3 guideline on atraumatic femoral head necrosis in adults aims to provide an overview of diagnosis and treatment. All clinical studies, systematic reviews, and meta-analyses published in German or English between 01.05.2013 and 30.04.2017 were included. Of 427 studies, 28 were suitable for analysis. Risk factors are corticosteroids, chemotherapy, kidney transplants, hemoglobinopathies, and alcoholism. Differential diagnoses are for example bone marrow edema, insufficiency fracture, and destructive arthropathy. Radiography should be performed upon clinical suspicion. In patients with normal radiography findings but persistent complaints, magnetic resonance imaging (ARCO classification) is the method of choice. Computed tomography (CT) can be used to confirm/exclude articular surface collapse. A subchondral sclerosis zone >30% in CT indicates a better prognosis. Left untreated, a subchondral fracture will develop within 2 years. The risk of disease development in the opposite side is high during the first 2 years, but unlikely thereafter. In conservative therapy, iloprost and alendronate can be used in a curative approach, the latter for small, primarily medial necrosis. Conservative therapy alone as well as other drug-based and physical approaches are not suitable for treatment. No particular joint-preserving surgery can currently be recommended. Core decompression should be performed in early stages with <30% necrosis. From ARCO stage IIIc or in stage IV, the indication for total hip arthroplasty should be checked. Results after total hip arthroplasty are comparable with those after coxarthrosis, although the revision rate is higher due to the relatively young age of patients. Statements on the effectiveness of cell-based therapies such as expanded stem cells or bone marrow aspirates cannot currently be made.

["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".