[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.

[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.

[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.

[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.

[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.

[Nutritional problems in palliative medicine]. / Ernährungsprobleme in der Palliativmedizin.

Malnutrition is a frequent problem in the palliative care of the seriously ill and dying. Want of appetite and los of weight are direct symptoms of patients with consumptive infectional diseases (AIDS, TBC) as well as cancer or geriatric patients. Severe malnutrition significantly contributes to a loss of quality of life and increases morbidity of palliative patients. The subjective well-being of seriously ill patients is heavily influenced by want of appetite and loss of weight. Patients often find want of appetite and the incapability to eat as pressing as the physical impairment caused by the disease. Therefore the sole aim of palliative dietotherapy has to be to strengthen the general physical and mental condition of the patient. A specific training of home care staff and relatives of seriously ill patients in dealing sensitively with this problem of care is desirable. Above all, in-patient treatment of affected patients for the sole purpose of feeding has to be avoided. Aggressive dietotherapeutic interventions, especially artificial feeding, should be refrained from as far as possible in the terminal phase. Only if the prognosis of a patient in palliative treatment is improving contrary to expectations are strategies of curative dietotherapy valid.

[Methodological standards of the evidence-based approach of clinical guidelines development in Germany. Consensus between the scientific community, self-governed bodies and practice]. / Methodische Standards der Entwicklung evidenz-basierter Leitlinien in Deutschland. Konsens zwischen Wissenschaft, Selbstverwaltung und Praxis.

The most appropriate method of clinical guidelines development has been the subject of controversial debates in Germany during the last few years. The German Guidelines Clearinghouse at the Society for Quality in Medicine (Cologne) provided a discussion forum where clinicians, methodologists, the Association of the Scientific Medical Societies, and the corporate self-governed bodies (the health insurances, physicians' associations, and the hospital associations) agreed on the most important methods of an evidence-based approach for guidelines development. It was generally agreed that rigorous methodological standards should be followed to ensure both the scientific quality and the consensus quality in the development or revision of clinical practice guidelines. The agreement draws on the following topics: Scientifically valid guidelines: (1) are based on a comprehensive and systematic review of the best available evidence, (2) derive the recommendations from the best available evidence, and (3) demonstrate explicitly how the recommendations are linked to the evidence. The quality of consensus is ensured through (1) the participation of all relevant stakeholders in the guideline panel and (2) the application of formal consensus development methods. This type of an "evidence-based consensus guideline" is assumed to possess the highest level of scientific and political legitimacy.

[Guidelines and evidence-based medicine in Germany]. / Leitlinien und Evidenz-basierte Medizin in Deutschland.

Clinical Practice Guidelines (CPGs) are increasingly common in the German health care system. The German physicians' self-governmental body's position regarding CPGs as a tool of Evidence-based medicine (EBM) was described in a joint policy paper concerning quality in health care in late 1998. The German Medical Association (GMA) and the National Association for Statutory Health Insurance Physicians (NASHIP) stated that "the principles of EBM should be implemented into the German Health Care System" by the following means: to assess systematically and appraise critically the evidence in health care to develop evidence-based consensus CPGs for priority problems in health care to implement CPGs using graduate, post-graduate, and continuing medical education, as well as audits and CPG-based information management to evaluate quality in health care against the background of CPGs. The following paper will discuss the aims and scopes and the limits of this concept.

[Goals, possibilities and limits of quality evaluation of guidelines. A background report on the user manual of the "Methodological Quality of Guidelines" check list]. / Ziele, Möglichkeiten und Grenzen der Qualitätsbewertung von Leitlinien. Ein Hintergrundsbericht zum Nutzermanual der Checkliste "Methodische Qualität von Leitlinien".

Recently a German appraisal instrument for clinical guidelines was published that could be used by various parties in formal evaluation of guidelines. An user's guide to the appraisal instrument was designed that contains a detailed explanation for each question to ensure that the instrument is interpreted consistently. This paper describes the purposes, format and contents of the user's guide, and reviews the key factors influencing the validity of guidelines. Taking into account international experiences, the purposes, chances and methodological limitations of a prospective assessment of clinical practice guidelines are discussed.

[Medical guidelines in Germany--current status and future developments]. / Arztliche Leitlinien in Deutschland--aktueller Stand und zukünftige Entwicklungen.

Medical guidelines are considered more and more as a meaningful and necessary tool ensuring a high quality of medical care. However, some doubts were recently mentioned concerning the quality of German guidelines. In 1997, the Society of Physicians of Germany and the Association of Panel Physicians have therefore initiated a program for the promotion of the quality of guidelines in Germany. Tools have been developed with the purpose to report and assess the quality of guidelines. Additionally, a "clearing-procedure for guidelines" and recommendations for the development of evidence-based guidelines were introduced. Background and content of these evaluation tools are reported in this article.

[Checklist for methodological quality of guidelines. A contribution to quality promotion of medical guidelines]. / Die Checkliste zur methodischen Qualität von Leitlinien. Ein Beitrag zur Qualitätsförderung ärztlicher Leitlinien.

The society of physicians of Germany and the society of panel physicians laid down in the "assessment criteria for guidelines in medical care" what kind of demands the medical selfadministration makes on guidelines. This measure also had the goal to support and strengthen the efforts of the AWMF for guidelines of high value. On the basis of these assessment criteria, a tool was compiled for the systematic registration and documentation of quality criteria for good guidelines for the first time in areas of German language. This check list is guided by the structure and content of the "Criteria for Appraisal for National Guidelines" by the Scottish Intercollegiate Guidelines Network.

[A concept for a clearing procedure for guidelines in Germany]. / Konzept eines Clearingverfahrens für Leitlinien in Deutschland.

Guidelines are efficient tools for the maintenance and improvement of the quality of care and contribute to the increase of the efficacy of care. However, the quality of guidelines has not been investigated or improved much in Germany. This is especially true for the formal assessment of guidelines regarding the collection and evaluation of evidence, their feasibility and their effects on health economy. There is an internationally recognized method available to examine and evaluate current and new guidelines with respect to these three categories. This paper proposes a clearing procedure for guidelines in Germany to systematically improve the quality of guidelines and to offer authors as well as users of guidelines valuable informations.

[Status and perspectives of quality assurance in socialized medical services]. / Stand und Perspektiven der Qualitätssicherung in der vertragsärztlichen Versorgung.

Quality, quality assurance, and quality management are becoming more and more dominating topics in German public health. Quality is named as the most important goal of medical care in the public health related political discussions of physicians, hospitals, health insurances, and politicians but is affected by differences in political, economical, medical, and particular interests. To avoid a single-sided discussion about questions of quality (only with the goal of increasing efficiency and reducing costs), the society of physicians of Germany and the society of panel physicians published a common stock of 10 theses about medical quality assurance and quality improvement in the spring of 1996: (1) Medical quality assurance and quality improvement serve the patient. (2) Medical quality assurance and quality improvement do not primarily serve the improvement of economic efficiency. (3) Quality assurance programs have to be problem oriented and coordinated; quality in the ambulant and hospital setting cannot be different. (4) The appropriateness of quality assurance programs has to be evaluated firmly. (5) Transparency, communication, and cooperation are prerequisites of a successful quality assurance and quality improvement. (6) Comprehensive internal quality assurance is the foundation of continuous quality improvement. (7) External quality assurance should initiate the development of procedures for internal quality assurance. (8) Quality assurance has a chance for realization only if it is carried by the conviction and the effort of every participant to perform at relatively high quality, to subject his own doing to continuous checks and improvement, and to compare with others. (9) Quality has it's price. (10) Quality assurance and continuous quality improvement are the cornerstones of a quality policy in public health. The current situation and future developments of quality assurance in ambulant health care are discussed in this paper.

[Quality assurance and continuous quality improvement--assessment of the current status of physician self-control for quality assurance in medicine 1955-1995]. / Qualitätssicherung und kontinuierliche Qualitätsverbesserung--Bestandsaufnahme der ärztlichen Selbstverwaltung zur Qualitätssicherung in der Medizin 1955-1995.

In April 1996 the working group of the leading statutory health service officials (Arbeitsgemeinschaft der Leitenden Medizinalbeamten der Länder [AGLMB]) organised a hearing in the course of which the German Medical Association and the National Association of CHI Physicians presented a joint stocktaking of their activities in the discipline of quality assurance during 1955 to 1995. On the basis of this analysis 10 theses have been evolved to develop quality assurance in Germany: (1) quality assurance and quality improvement are in the interest of the medical care of patients. (2) The main task of quality assurance and quality improvement is not the improvement of efficiency. (3) Quality assurance schemes must be problem-orientated and coordinated; there must not be a difference in the quality of out-patient and in-patient medical care. (4) There has to be a systematic evaluation of the suitability of quality assurance schemes. (5) Transparency, communication and cooperation are preconditions for a successful quality assurance and quality improvement. (6) Continuous quality improvement is based on an extensive internal quality assurance. (7) The initiative for the priority development of internal quality assurance procedures must come from external quality assurance. (8) Quality assurance has only a chance of being realised if the individual is convinced and anxious to provide high-quality services, to continuously review and improve his services and to compare them with other services. (9) Quality has its price. (10) Quality assurance and continuous quality improvement are the cornerstones of a quality policy in the health care system. The article concludes with extracts from the checkup and the relevant literature.