[The German Agency for Quality in Medicine (ÄZQ) 1995-2010: 15 years promotion of evidence-based medicine, patient orientation and patient safety]. / Das Ärztliche Zentrum für Qualität in der Medizin 1995-2010: 15 Jahre Förderung von Evidenzbasierter Medizin, Patientenorientierung und Patientensicherheit.

The German Agency for Quality in Medicine (ÄZQ) was established as a joint institution of the German Medical Association (BÄK) and the National Association of Statutory Health Insurance Physicians (KBV) in 1995. Starting as a small quality assurance co-ordination unit of the German physicians' national self-governmental bodies, ÄZQ has been developed during the last decade into a centre of excellence for clinical practice guidelines, patient information, patient safety, evidence-based medicine, and knowledge management. The article summarises the institution's acitivities over the period of 15 years with respect to its national projects and international collaboration, being a founding member of the Guidelines International Network. In the future ÄZQ's programme priorities will be in the fields of knowledge transfer and implementation of medical decision aids into the daily work of health-care providers.

[The German National Disease Management Guideline "Chronic Heart Failure"]. / Nationale VersorgungsLeitlinie Chronische Herzinsuffizienz.

Chronic heart failure (CHF) is an illness mostly affecting elderly people. In Germany CHF is one of the most common causes of death and at the same time one of the most common diagnosis in inpatient care. Due to the expected increase in life expectancy in the next few years experts predict a further step-up of the incidence. Against this background development of a national guideline on chronic heart failure was prioritised and accordingly the National Disease Management Guideline (NDMG) Chronic Heart Failure was developed by a multi- and interdisciplinary group. The guideline group comprised experts from all relevant scientific medical societies as well as a patient expert. The National Disease Management Guideline (NDMG) on Chronic Heart Failure aims at supporting patients and health care providers with respect to decisions on a specific health care problem by giving recommendations for actions. Recommendations are informed by the best available scientific evidence on this topic.Patients with CHF often suffer from multiple conditions. Due to this fact and the old age patients do have very complex and demanding health care needs. Thus accounting for co-morbidities is paramount in planning and providing health care for theses patients and communication between doctor and patient but also between all health care providers is crucial.Basic treatment strategies in chronic heart failure comprise management of risk factors and prognostic factors as well as appropriate consideration of co-morbidities accompanied by measures empowering patients in establishing a healthy life style and a self-dependant management of their illness.Psycho-social aspects have a very strong influence on patients' acceptance of the disease and their self-management. In addition they have a strong influence on therapy management of the treating physician thus they have to be addressed adequately during the consultation.The National Disease Management Guideline (NDMG) Chronic Heart Failure (CHF) is an interdisciplinary guideline putting particular emphasis on giving recommendations for health care management at the interfaces of the health care system. The NDMG CHF provides a collection of evidence-based and consensus-based recommendations for diagnostics and therapy of patients with CHF. This CPG is meant to improve health care for all affected patients regardless of stage of disease or health care setting. Quality improvement though can only happen when the NDMG CHF is adopted into daily routine. To support implementation a patient version of the guideline was developed. The article compiles the most relevant recommendations and algorithms of the National Disease Management Guideline (NDMG) Chronic Heart Failure (CHF).

[Evidence-based therapy of depression: S3 guidelines on unipolar depression]. / Evidenzbasierte Therapie der Depression: Die S3-Leitlinie unipolare Depression.

Unipolar depressive disorders are among the most frequent reasons for utilizing the health care system. Although efficacious treatments are available and further advances have recently been made there is still a need for improving diagnostic and therapeutic procedures. Alignment of treatment on evidence-based treatment guidelines establishes an essential mainstay. The new S3 and National Health Care guidelines on unipolar depression, the compilation of which was coordinated by the German Society of Psychiatry, Psychotherapy and Neurology (DGPPN) and which were approved by 29 scientific and professional associations, is the ambitious effort to present state of the art evidence and clinical consensus for the treatment of depression. For pharmacotherapy of depression differentiated recommendations can be given, also separate from and in addition to psychotherapy.

[Methodology and process of developing the S3 guideline for prostate cancer]. / Methodik und Entwicklungsprozess der S3-Leitlinie zum Prostatakarzinom.

Despite the high incidence of prostate cancer and a variability of care due to different options for primary therapy, a comprehensive German clinical guideline has been missing up to now. Therefore, in 2005 the German Society for Urology initiated the development of a multidisciplinary and evidence-based S3 guideline for the early detection, diagnosis, and treatment of the different clinical manifestations of prostate cancer. There were 76 experts from 10 different medical societies and organizations including a patient organization involved in the development process. A total of 42 key questions were addressed. As a result of systematic literature searches and formal consensus processes, 170 recommendations and 42 statements were made. This article describes the objectives and the process of development of the guideline focusing on the cooperation between clinical and methodological experts as well as on the evidence and consensus basis of the recommendations.

[What is most important is what comes across : Urological guidelines from the target group's point of view]. / Entscheidend ist, was ankommt : Urologische Leitlinien aus Sicht der Zielgruppe.

BACKGROUND: Guidelines are developed to improve the quality of patient care. The effect of German urologic guidelines has not been evaluated so far. Therefore, we aimed to systematically investigate the acceptance, use, and quality of the published guidelines from a user's perspective. METHODS: A link to an online questionnaire concerning use and barriers to the application of guidelines was distributed via e-mail by the German Society of Urology (DGU). German urologists' opinions on differences in national guideline quality were evaluated regarding prostate cancer (PCA), bladder cancer, germ cell tumors (GCT), renal cell carcinomas, and erectile dysfunction. RESULTS: Four hundred sixty-seven German urologists participated. More than 90% of the participants considered guidelines to be helpful. The Internet as the main tool for guideline distribution was favored by 28.4%, followed by publication in Urologe A. The main barrier to guideline usage was attributed to the lack of up-to date clinical data. Guidelines for GCT scored best in all quality categories and reached the highest level of use (65.8%), and 40.5% of participating urologists considered the additional establishment of comprehensive care centers for GCT as more effective for quality improvement than guideline development alone. For the other urologic tumors, especially PCA, guideline development was favored as a tool for quality improvement. CONCLUSION: More than 90% of participating urologists accept clinical guidelines as useful instruments in clinical practice and for therapeutic decisions. Our results should be integrated into guideline dissemination and implementation strategies in order to achieve a higher degree of treatment conformation to guidelines.

[Guidelines as a basis for future-oriented health care management]. / Leitlinien - Grundlage neuer, zukunftsweisender Versorgungsformen.

Due to the highly divided structure of the German health care system, patients are usually cared for within sectors or along sectoral borders and not according to the ideal process of care. Often, as a result of this, individual working steps in health care are carried out parallel to each other in an uncoordinated fashion. The insufficient exchange of information and the lack of coordination of procedures between the involved members of the care process can lead to severe disruptions in the delivery of care. This creates problems like superfluous diagnostic and therapeutical interventions or a higher likelihood of mistakes, for example, when it comes to pharmacological therapy. With improved organization (communication, coordination and cooperation), optimization in the areas of quality and cost effectiveness can be expected. High-quality evidence-based guidelines or clinical pathways developed from evidence-based guidelines define ideal process sequences and requirements for structure, process and outcome quality. Thus, they can play a supporting role in the integration of medical care services in terms of organization and content. Hereby evidence-based quality indicators serve as tools for process supervision. Guideline-based Integrated Care Contracts pose an excellent opportunity for the implementation of guidelines. At the same time, integrated care based on high-quality guidelines can considerably contribute to improving the quality of medical health care.

[Development of national guidelines for depression]. / Entwicklung der S3- und Nationalen Versorgungs-Leitlinie Depression.

Depressive disorders rank among the most frequent causes of consultation and diseases in health care. Although they are treatable, there is further need to optimize diagnostics and therapy, despite sizable progress in recent years. The implementation of evidence- and consensus-based guidelines is an appropriate measure to improve care for depressive patients. An evidence-based guideline for depression is currently being developed for Germany. In order to ensure its acceptance and a wide dissemination, this guideline will be adopted in consensus by all relevant health care providers in this field. According to this, it is a future challenge to anchor guideline-based diagnostics and treatment in routine care.

[The National Programme for Disease Management Guidelines. Goals, contents, patient involvement]. / Das Programm für Nationale VersorgungsLeitlinien von BAK, AWMF und KBV : Ziele, Inhalte, Patientenbeteiligung.

The Programme for National Disease Management Guidelines (German DM-CPG Programme) aims at the implementation of best practice recommendations for prevention, acute care, rehabilitation and chronic care. The programme, focussing on high priority healthcare topics, has been sponsored since 2003 by the German Medical Association (BAEK), the Association of the Scientific Medical Societies (AWMF), and by the National Association of Statutory Health Insurance Physicians (KBV). It is organised by the German Agency for Quality in Medicine, a founding member of the Guidelines International Network (G-I-N). The main objective of the programme is to establish consensus of the medical professions on evidence-based key recommendations covering all sectors of health care provision and facilitating the coordination of care for the individual patient through time and across disciplines. Within this framework experts from national patient self-help groups have been developing patient guidance based upon the recommendations for healthcare providers. The article describes goals, topics and selected contents of the DM-CPG programme - using asthma as an example.

[Evidence based guidelines and clinical pathways: complementation or contradiction?]. / Evidenzbasierte Leitlinien und Behandlungspfade: Ergänzung oder Widerspruch?

Even methodological sound guidelines will only achieve their goals when the recommendations are transferred into practice. Guideline introduction and dissemination must therefore be accompanied by active implementation measures. For inpatient care clinical pathways can serve as tools, especially taking advantage of their sequential character. Complementary evidence based guidelines can serve as an optimal source of systematically appraised evidence in developing clinical pathways. Considering them is of major help to assure that the content of clinical pathways is in accordance with evidence. The article highlights methodological requirements in guideline and pathway development and gives prospects on how both tools can be used together.

[Glossary on patient safety -- a contribution to on-target-definition and to appreciate the subjects of "patient safety"]. / Das Glossar Patientensicherheit -- Ein Beitrag zur Definitionsbestimmung und zum Verständnis der Thematik "Patientensicherheit" und "Fehler in der Medizin".

Since the release of the report "To Err is Human" by the American Institute of Medicine (IOM) the subject "Medical Risks, Errors and Patient Safety" has gained increasing interest in literature. In Germany, neither extensive statistics nor generally significant epidemiological studies regarding common errors associated with damages caused to patients' health exist. In recent years the subject has become increasingly interesting both in specialist discussion and it the lay press; it has become evident that the different use of terms, especially those originating from the Anglo-Saxon language, can lead to misunderstandings. Hence, as one of the first steps of its action programme, the expert panel "Patient Safety" of the German Agency for Quality in Medicine has compiled a glossary of technical terms to provide adequate support to the discussion this important subject of nomenclature.

Improving the quality of health care: using international collaboration to inform guideline programmes by founding the Guidelines International Network (G-I-N).

Clinical practice guidelines are regarded as powerful tools to achieve effective health care. Although many countries have built up experience in the development, appraisal, and implementation of guidelines, until recently there has been no established forum for collaboration at an international level. As a result, in different countries seeking similar goals and using similar strategies, efforts have been unnecessarily duplicated and opportunities for harmonisation lost because of the lack of a supporting organisational framework. This triggered a proposal in 2001 for an international guidelines network built on existing partnerships. A baseline survey confirmed a strong demand for such an entity. A multinational group of guideline experts initiated the development of a non-profit organisation aimed at promotion of systematic guideline development and implementation. The Guidelines International Network (G-I-N) was founded in November 2002. One year later the Network released the International Guideline Library, a searchable database which now contains more than 2000 guideline resources including published guidelines, guidelines under development, "guidelines for guidelines", training materials, and patient information tools. By June 2004, 52 organisations from 27 countries had joined the network including institutions from Oceania, North America, and Europe, and WHO. This paper describes the process that led to the foundation of the G-I-N, its characteristics, prime activities, and ideas on future projects and collaboration.

[The German guideline clearing-project on bronchial asthma - part 2: recommendations and key topics for a national guideline on bronchial asthma]. / Das Leitlinien-Clearingverfahren Asthma bronchiale - 2. Empfehlungen zu Eckpunkten für eine nationale Leitlinie Asthma bronchiale.

BACKGROUND: In order to promote the quality of asthma management in Germany, a national asthma guidelines clearing project was initiated in 2000 by the German Guidelines Clearinghouse (Sponsors: German Medical Association (GMA), National Association of the Statutory Health Insurance Physicians (NASHIP), German Hospital Federation, Federal Association of the Statutory Sickness Funds. This Part shows the key topics which should be dealt with in a German guideline on bronchial asthma. SUMMARY POINTS: For quality promotion of bronchial asthma management in Germany, the development of a national evidence-based guideline, using the internationally accepted quality criteria for clinical practice guidelines, was recommended by an expert group of the German Guideline Clearinghouse. The experts identified and peer-reviewed 16 out of 54 guidelines, which might be useful as benchmarks and examples for a German asthma guideline. From the peer review results, the expert group identified 18 key topics for a national asthma guideline.

[The German Quality Management System for Outpatient Care (Q-M-A) Checklist--an instrument for assessing quality management systems in outpatient care]. / Die Checkliste Q-M-A--ein Instrument zur Bewertung von Qualitätsmanagementsystemen in der ambulanten Versorgung.

Quality management systems had originally been designed for industrial purposes and were hardly applicable for small enterprises, there have been adjustments to the two main applications EFQM and ISO enabling utilisation also in ambulatory care. There are also different approaches like the Dutch Visitatiae concept which reflects the needs of GP's and is based on peer exchange. The presented paper gives an overview of existing quality management and certification systems and presents an instrument for evaluation. This checklist was developed by an interdisciplinary expert panel of the Agency for Quality in Medicine and serves as an aid for users and graders of quality management systems with regard to the feasibility of these systems.

[The German guideline clearing-project on bronchial asthma-part 1: Methodology and results of formal appraisal]. / Das Leitlinien-Clearingverfahren Asthma bronchiale--1. Methodik und Ergebnisse der formalen Bewertung.

BACKGROUND: In order to promote quality of asthma management in Germany, a national asthma guidelines clearing project was initiated in 2000 by the German Guidelines Clearinghouse (Sponsors: German Medical Association (GMA), National Association of the Statutory Health Insurance Physicians (NASHIP), German Hospital Federation, Federal Association of the Statutory Sickness Funds. Part 1 of this article shows the methodology and the results of the appraisal, part 2 (to be published) shows the key topics which should be dealt with in a german guideline on bronchial asthma. OBJECTIVES: To identify and compare evidence-based, high-quality German- and English language asthma guidelines as benchmarks for ongoing guideline development and implementation programmes. To disseminate information about asthma guidelines developed in accordance with current methodological know-how. To identify and consent key topics for a national evidence-based guideline for Germany. METHODS: Search procedure, formal appraisal: Systematic search using literature databases (XMED, incl. Medline and Embase) and English-/German-language guideline databases (via www. leitlinien.de), published between January 1990 and March 2000. Abstract screening of the search results according to the inclusion criteria (n = 54 of a total of 502 hits). Methodological guideline evaluation of 16 guidelines using the German checklist for methodological guideline appraisal. Appraisal of guidelines' contents: Peer review of guidelines with the following inclusion criteria: Bronchial Asthma-general, German and English language, based in references published later than 1994, new guideline or actual update. Peer review was performed by a multidisciplinary focus group of EBM experts (clinical and ambulatory settings). No expert was involved in guideline production during the review period. RESULTS: Methodological appraisal: 16 out of guidelines were in accordance with the formal minimal standard with a wide range within the following domains: "description of the development process", "declaration of authors' independence", "explicit link between recommendations and the supporting evidence", "management options", "tools for implementation". The focus group recommended for future national asthma guidelines to rely on the following procedures: (1) to formulate the recommendations using standardized, clearly described consensus methods basing on evidence retrieved and selected in a systematic way (2) to prove links between recommendations and supporting evidence (3) to develop guideline versions for health care professionals as well as for consumer/patients (4) to develop guideline-based education tools (5) to ensure periodical updates of the asthma guideline (6) to consider the methodological recommendations and to give reasons for deviations from the methodological recommendations. APPRAISAL OF GUIDELINES CONTENT: None of the guidelines identified comprised information about all of the following key topics considered to be relevant for a German national guideline by the focus group: (1) intended guideline users/goals, (2) definition (3) cause of disease, (4) form of disease, (5) severity, (6) diagnosis, (7) therapeutic goals, (8) prevention, (9) pharmacotherapy, (10) non-pharmacotherapy, (11) therapy control and compliance, (12) emergency treatment, (13) rehabilitation, (14) comorbidity, (15) special aspects, (16) coordination of care, (17) quality assurance/quality management, (18) implementation. SUMMARY POINTS: For quality promotion of bronchial asthma management in Germany, the development of a national evidence-based guideline, using the internationally accepted quality criteria for clinical practice guidelines, was recommended by an expert group of the German Guideline Clearinghouse. The experts identified and peer-reviewed 16 out of 54 guidelines, which might be useful as benchmarks and examples for a German asthma guideline. From the peer review results, the expert group identified 18 key topics for a national asthma guideline.

[Assessment and implementation of guidelines]. / Bewertung und Implementierung von Leitlinien.

The importance of guidelines increases continuously on the political level whereas on the user level reservations and uncertainty persist. Consequently guidelines are not considered as they should be. Guidelines will develop their effectiveness only if they are firmly implemented in the delivery process. Acceptance problems spring from problems in development and from aspects of dissemination and implementation not sufficiently considered so far. Therefore a lot of countries have developed quality criteria for guidelines and programmes for quality promotion. To further the use of guidelines in the care process aspects of dissemination and implementation have to be recognized even in the development process. This has not been recognized sufficiently so far. Implementation of guidelines is a systematic approach which has to be connected seamlessly with other activities (e. g. quality management). The implementation process should be accompanied and evaluated so that a continuous adjustment is possible. Most of the existing guideline programmes do not consider this sufficiently. The following contribution gives a survey of results and introduces means and instruments for assessment and implementation of guidelines.

[Current initiatives in Germany for translating national guidelines into reality - a survey]. / Aktuelle Initiativen zur Realisierung nationaler Leitlinien in Deutschland - eine Ubersicht.

The role of practice guidelines as a tool for quality management in health care is now widely accepted in Germany- not only by health professionals, but also in politics. The physicians' professional associations as well as health care authorities (physicians' self-governmental bodies) and parliament introduced several incentives and regulations, aiming at a regular use of guidelines in health care. Among these the German guideline clearinghouse with the systematic approach towards identification, dissemination, and implementation of best available evidence-based guidelines, as well as the country-wide implementation of disease management guidelines seem to be effective and efficient in quality management as well as in patient care management in the German health care system. The article gives an overview on background, procedures and barriers to country-wide implementation of clinical practice guidelines within a social security health care system.

[Knowledge management in rehabilitation--proposal for a systematic development of clinical practice guidelines]. / Wissensmanagement in der Rehabilitation - Vorschlag zu einer systematischen Entwicklung von Leitlinien.

In the past ten years, the German pension scheme has launched several initiatives that can be regarded as milestones on the way to a scientifically founded rehabilitation system. These initiatives were: the Rehab Commission (1989 - 1991), the Quality Assurance Programme (since 1994), and the German Research Funding Programme "Rehabilitation Sciences" (in cooperation with the Federal Ministry for Education and Research, since 1996). As a next step on this way, we propose an initiative aiming at a systematic development and implementation of clinical practice guidelines for the main diagnostic groups in rehabilitation. Guidelines for diagnostic and therapeutic decisions are an instrument to sift through the abundance of fast changing knowledge in medicine, to assess the existing knowledge according to its scientific evidence, and to transform it into recommendations for clinical practice. In rehabilitation, guidelines seem to be particularly needed because specialized knowledge is mostly disseminated through an informal "training on the job". Our proposal intends to establish a reference centre for each of the main indications (cardiology, musculoskeletal diseases, etc.). These centres should cooperate with experts from clinical practice and research, as well as with representatives of the cost-carrying agencies and patient organisations, and should systematically analyse the processes of rehabilitation in the most important diagnostic groups. Guided by a "process matrix of rehabilitation", these analyses should identify the points at which far-reaching decisions are called for during the processes of rehabilitation. At these points, the knowledge base available for rational decisions should be examined. When there is no sufficient scientific knowledge, consensus conferences should be organized in order to collect and assess the available expertise of practitioners and to establish guidelines for clinical practice. Since compliance with such guidelines could be easily checked in the routine quality assurance programme, this proposal seems to be a promising way of improving the knowledge base in rehabilitation in a rather short time.

[Well-informed on health matters--how well? The German 'Clearinghouse for Patient Information'--objective, background and methods]. / Gut informiert über Gesundheitsfragen, aber wie? Das Deutsche Clearingverfahren für Patienteninformationen--Zielsetzung, Hintergrund und Arbeitsweise.

OBJECTIVE: Health information for lay people in print or electronic form are internationally recognised as useful tools and as necessary in the decision-making process of individuals. The effectiveness of offered patient information depends on quality and accessibility. Because much of the available health information is significantly deficient, the Agency for Quality in Medicine developed a programme for assessing the quality of specialised health and medical information for all non-medically trained persons. The German 'Clearinghouse for Patient Information' project is an adjunct to the already established German 'Clearinghouse for Clinical Guidelines'. METHOD: The basis for quality improvement for specialised medical information consists 1. in the determination of demands on quality for patient information published in the German language, 2. development of a standardised instrument for assessing the quality of specialised medical information by non-medically trained persons, 3. establishment of an Internet portal for evaluated and rated material, and 4. the establishment and organisation of relevant partnerships with information providers and users of health and medical information. The principle building block to rate medical information for lay people are the DISCERN criteria for good patient information. The results of the quality rating of specialised medical information are made available to the public with emphasis on promoting transparency of the assessment and rating processes used. RESULTS: The Internet-based patient information service of the Agency for Quality in Medicine (www.patienten-information.de 19.06.02) has currently a selection of approximately 800 information items covering fifty disease topics with fully or partially evaluated and rated information. Partnerships to appropriate information providers and users are already established and have been tested in special single projects. CONCLUSION: To advance the process of quality improvement for medical information for non-medical and lay persons, it is essential to develop and to intensify the cooperation with stake holders and partners at different levels. Only through close cooperation with others it is possible to create a basis to continuously develop and improve the information quality assessment instrument further. In addition, effective strategies need to be developed to disseminate these endeavours to patients and consumers of health information in a user-friendly and transparent way.