Prof. Dr.rer.nat. Dr.med. Günter Ollenschläger, FRCP Edin, FACP a certified pharmacist and general internist, has been chief editor of the German Journal for Evidence and Quality in Healthcare ZEFQ (www.zefq.de) and head of the German Agency for Quality in Medicine (www.aezq.de) since 1995. He was co-founder of the German Network for Evidence Based Medicine (www.dnebm.de) and of the Guidelines International Network (www.g-i-n.net). GO is associate professor for internal medicine at the University of Cologne.
Abstract: The German Agency for Quality in Medicine (ÃZQ) was established as a joint institution of the German Medical Association (BÃK) 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, ÃZQ 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 ÃZQ'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.
Abstract: 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).
Abstract: Reader Survey: Are standards needed for clinical guideline development? Tell us what you think. Guideline development processes vary substantially, and many guidelines do not meet basic quality criteria. Standards for guideline development can help organizations ensure that recommendations are evidence-based and can help users identify high-quality guidelines. Such organizations as the U.S. Institute of Medicine and the United Kingdom's National Institute for Health and Clinical Excellence have developed recommendations to define trustworthy guidelines within their locales. Many groups charged with guideline development find the lengthy list of standards developed by such organizations to be aspirational but infeasible to follow in entirety. Founded in 2002, the Guidelines International Network (G-I-N) is a network of guideline developers that includes 93 organizations and 89 individual members representing 46 countries. The G-I-N board of trustees recognized the importance of guideline development processes that are both rigorous and feasible even for modestly funded groups to implement and initiated an effort toward consensus about minimum standards for high-quality guidelines. In contrast to other existing standards for guideline development at national or local levels, the key components proposed by G-I-N will represent the consensus of an international, multidisciplinary group of active guideline developers. This article presents G-I-N's proposed set of key components for guideline development. These key components address panel composition, decision-making process, conflicts of interest, guideline objective, development methods, evidence review, basis of recommendations, ratings of evidence and recommendations, guideline review, updating processes, and funding. It is hoped that this article promotes discussion and eventual agreement on a set of international standards for guideline development.
Abstract: 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.
Abstract: Evidence-based guidelines are important sources of knowledge in everyday clinical practice. In 2005, the German Society for Urology decided to develop a highquality evidence-based guideline for the early detection, diagnosis and treatment of the different clinical manifestations of prostate cancer. The guideline project started in 2005 and involved 75 experts from 10 different medical societies or medical organizations including a patient organization. The guideline was issued in September 2009 and consists of 8 chapters, 170 recommendations, and 42 statements. Due to the broad spectrum of clinical questions covered by the guideline and the high number of participating organizations and authors, the organizers faced several methodological and organizational challenges. This article describes the methods used in the development of the guideline and highlights critical points and challenges in the development process. Strategies to overcome these problems are suggested which might be beneficial in the development of new evidence-based guidelines in the future.
Abstract: 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.
Abstract: 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.
Abstract: The involvement of patients in the development of clinical guidelines essentially aims at ensuring and improving the quality of patient-centred care. Hence, it becomes an important tool for quality management in medicine since patients are learning the hard way where clinical care is lacking. This may include the inappropriate consideration of current medical knowledge, the unintelligible or insufficient information and education of the patient or information gaps at the interface between care settings. These experiences from the patients' perspective can be purposefully integrated in quality assurance measures, for example, by including the patient perspective in clinical guidelines and patient guidelines. Suitable procedures for the collection and presentation of the experiences of patient organisations are essential for the successful involvement of patients in guideline programmes. Patient organisations collect data on the experiences and attitudes of their members for different purposes. A systematic approach has been sought but hardly practised so far. This is the result demonstrated in a survey among 112 member organisations of the "Bundesarbeitsgemeinschaft SELBSTHILFE von Menschen mit Behinderung und chronischer Erkrankung und ihren Angehörigen e.V." (BAG SELBSTHILFE), a federal German self-help association of disabled and chronically ill people and their relatives. Patient participation in the "Programm for Nationale VersorgungsLeitlinien" ["Programme for National Disease Management Guidelines"] has been practised at the Agency for Quality in Medicine (AEZQ) since 2005. The experiences that have been made by those involved with integrating the concerns of patient representatives provide a starting point for a practical handout for patients and consumers participating in guideline programmes. The "Handbuch Patientenbeteiligung-Beteiligung am Programm für Nationale VersorgungsLeitlinien" [Handbook of Patient Participation in the Programme for National Disease Management Guidelines] is intended to make the process of patient participation in guideline programmes transparent and practicable. It describes the background, the organisation and the process of patient participation and offers useful advice to participating patient organisations and their representatives. In this context the question of how patient experiences might be introduced in the guideline and patient guideline development process in a structured and purposeful manner is of special importance. But so far there is too little experience, both nationally and internationally. A survey among self-help organisations shall provide an initial overview.
Abstract: 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.
Abstract: 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.
Abstract: In Germany, the first national consensus between 14 medical scientific associations on evidence-based recommendations for prevention and therapy of foot problems in type 2 diabetes was reached in fall 2006. The recommendations' main sources are the NICE Guideline 2003 on foot problems in type 2 diabetes, as well as existing German guidelines and reviews of recent scientific evidence. The article gives an overview on authors, sources, and key recommendations of the German National Disease Management Guideline Type 2 Diabetes - Diabetic Foot 2006 (www.diabetes.versorgungsleitlinien.de).
Abstract: The Program for National Disease Management Guidelines (German DM-CPG Program) is a joint initiative of the German Medical Association (umbrella organization of the German Chambers of Physicians), the Association of the Scientific Medical Societies (AWMF), and of the National Association of Statutory Health Insurance Physicians (NASHIP). The program aims at developing, implementing and continuously updating best-practice recommendations for countrywide and regional disease management programs in Germany. Since 2003 twelve national guidelines (topics: asthma, chronic obstructive pulmonary disease, HI (Chronic heart failure), CVD (Chronic coronary heart disease) back pain, depression, several aspects of diabetes) have been produced by use of a standardized procedure in accordance with internationally consented methodologies. For countrywide dissemination and implementation the program uses a wide range of specialist journals, continuous medical education and quality management programs. So far, 36 out of 150 national scientific medical associations, four allied health profession organizations, and twelve national consumer organizations have been participating in the DM-CPG Program. Studies to evaluate the program's effects on health-care providers' behavior and patients' outcomes are under way.
Abstract: In discussions on the quality of cross-sectorial health-care services high importance is attributed to patient education and patient counseling, with guideline-based patient information being considered a crucial tool. Guideline-based patient information is supposed to serve patients as a decision-making basis and, in addition, to also support the implementation of the guidelines themselves. The article highlights how patient guidelines for National Disease Management Guidelines in Germany--within the scope of patient education and patient counseling--may provide a uniform information platform for physicians and patients aiming to promote shared decision-making. The authors will also address the issue which contents should be included in patient guidelines in order to meet these requirements and which measures are required to review their quality. The present paper continues the series of articles on the Program for German National Disease Management Guidelines.
Abstract: 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.
Abstract: In Germany, the first national consensus between six medical scientific associations on evidence-based recommendations for prevention and therapy of retinopathy/maculopathy in type 2 diabetes was reached in fall 2006. The recommendations' main sources are the NICE Retinopathy Guideline 2002, and existing German guidelines and reviews of recent scientific evidence. The article gives an overview on authors, sources, and key recommendations of the German National Disease Management Guideline Type 2 Diabetes-Retinopathy/Maculopathy 2006 (www.diabetes.versorgungsleitlinien.de).
Abstract: Patient involvement has been implemented in the Program for National Disease Management Guidelines since 2005. Currently patient/consumer participation is being incorporated in terms of patients' comments of consultation papers on National Disease Management Guidelines (NDMG) and in the development of NDMG-based patient guidelines (PG). The editorial activities in patient guideline development from the beginnings to its publication are conducted in close cooperation with the patient representatives appointed by the Patient Forum. Between June 2005 and September 2006, three NDMG and three patient guidelines on asthma, chronic obstructive pulmonary disease (COPD) and chronic coronary artery disease (CAD) were produced by including patients in the guideline development process. The information provided in these guidelines is freely accessible at http://www.versorgungsleitlinien.de. The present contribution focuses on the development of patient guidelines. It describes the current state of patient involvement and joint work and indicates the implications that can be derived from patient participation in the NDMG Program. Accompanying the involvement procedures, experiences resulting from previous NDMG and PG development activities are continuously investigated for the possibility of further methodological development of consumer participation by a work group of the Patient Forum in coordination with the patient organizations involved. In particular, the procedures resulting from more intensive patient participation in patient guideline development are to be examined as to their relevance for the expansion of patient involvement in NDMG development.
Abstract: In Germany, the first national consensus on evidence-based recommendations for COPD prevention and disease management was reached in spring 2006. After a development period of 9 months, the National Disease Management Guideline COPD was finalized by nominal group process under the authorship of the scientific societies for pneumology (DGP and Atemwegsliga), general internal medicine (DGIM), family medicine (DEGAM), and the Drug Commission of the German Medical Association (AKDAE). The recommendations' main sources are the NICE COPD Guideline 2004, the GOLD Recommendations as well as existing German guidelines and reviews of recent scientific evidence. The article gives an overview on authors, sources, and key recommendations of the German National Disease Management Guideline COPD 2006 (www.copd.versorgungsleitlinien.de).
Abstract: In Germany, physicians enrolled in disease management programs are legally obliged to follow evidence-based clinical practice guidelines. That is why a Program for National Disease Management Guidelines (German DM-CPG Program) was established in 2002 aiming at implementation of best-practice evidence-based recommendations for nationwide as well as regional disease management programs. Against this background the article reviews programs, methods and tools for implementing DM-CPGs via clinical pathways as well as regional guidelines for outpatient care. Special reference is given to the institutionalized program of adapting DM-CPGs for regional use by primary-care physicians in the State of Hesse.
Abstract: 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.
Abstract: 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.
Abstract: Depressive disorders are of great medical and political significance. The potential inherent in achieving better guideline orientation and a better collaboration between different types of care is clear. Throughout the 1990s, educational initiatives were started for implementing guidelines. Evidence-based guidelines on depression have been formulated in many countries.
Abstract: The German National Program for Disease Management Guidelines, which is being operated under the auspices of the German Medical Association (GMA), the Association of the Scientific Medical Societies (AWMF) and the National Association of Statutory Health Insurance Physicians (NASHIP), provides a conceptual basis for the disease management of prioritized healthcare aspects. The main objective of the program is to establish consensus of the medical professions on key recommendations covering all sectors of healthcare provision and facilitating the coordination of care for the individual patient through time and across interfaces. Within the scope of this program, the Scientific Medical Societies concerned with the prevention, diagnosis, treatment and rehabilitation of asthma in children, adolescents and adults have reached consensus on the core contents for a National Disease Management Guideline for Asthma. This consensus was reached by applying formal techniques and on the basis of the adaptation of recommendations from existing guidelines with high quality standards in methodology and reporting, and information from evidence reports.
Abstract: In Germany, the first national consensus on evidence-based recommendations for disease management in patients with chronic coronary heart disease was reached in summer 2006. After a development period of 4 years, the National Disease Management Guideline Chronic Coronary Heart Disease was finalized by nominal group process under the authorship of the scientific associations for cardiac rehabilitation (DGPR), cardiac surgery (DGTHG), cardiology (DGK), general internal medicine (DGIM), family medicine (DEGAM), and the Drug Commission of the German Medical Association (AKDAE). The recommendations' main sources are the ACC/AHA guidelines 2002 updates as well as existing German guidelines and reviews of recent scientific evidence. The article gives an overview on authors, sources, and key recommendations of the German National Disease Management Guideline Chronic Coronary Heart Disease 2006 (www.khk.versorgungsleitlinie.de).
Abstract: The National Disease Management Program (NDM Program) represents the basic content of structured, cross-sectoral healthcare. In particular, the NDM Program is directed towards coordinating different disciplines and areas of healthcare. The recommendations are developed through interdisciplinary consensus of the scientific medical societies on the basis of the best available evidence. Within this scope the scientific medical societies concerned with the prevention, diagnosis, therapy and rehabilitation of asthma consented upon a National Disease Management Guideline for Asthma in 2005. Among other things, the following cornerstones of asthma prevention were agreed upon: Breastfeeding and non-smoking were suggested as primary prevention measures for (expectant) parents. With respect to secondary prevention, recommendations have been made for allergen avoidance, active/passive smoking and immunotherapy. Regarding tertiary prevention, position statements on vaccination and specific immunotherapy are developed. The present paper presents both the original texts of the recommendations and the evidence underlying them.
Abstract: The Program for National Disease Management Guidelines (German DM-CPG Program) was established in 2002 by the German Medical Association (umbrella organization of the German Chambers of Physicians) and joined by the Association of the Scientific Medical Societies (AWMF; umbrella organization of more than 150 professional societies) and by the National Association of Statutory Health Insurance Physicians (NASHIP) in 2003. The program provides a conceptual basis for disease management, focusing on high-priority health-care topics and aiming at the implementation of best practice recommendations for prevention, acute care, rehabilitation and chronic care. It is organized by the German Agency for Quality in Medicine, a founding member of the Guidelines International Network (G-I-N). The main objective of the German DM-CPG Program 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 interfaces. Within the last year, DM-CPGs have been published for asthma, chronic obstructive pulmonary disease, type 2 diabetes, and coronary heart disease. In addition, experts from national patient self-help groups have been developing patient guidance based upon the recommendations for health-care providers. The article describes background, methods, and tools of the DM-CPG Program, and is the first of a publication series dealing with innovative recommendations and aspects of the program.
Abstract: The role of clinical practice guidelines (CPG) as a tool for continuous medical education (CME), and quality management in health care is now widely accepted in Germany. Since the 90ies, the physicians' professional associations as well as health care authorities and parliament have been introducing several incentives and regulations in order to promote the use of evidence based CPG. In the past German CPG agencies have been focussing their work on developing and optimising methodological CPG standards. Future CPG activities should address much more other key factors for the success of CPGs, such as medical relevance, practicability, effective dissemination, and implementation. The article describes the process of guideline adaptation by regional physician audit groups as a tool for CPG implementation.
Abstract: Clinical practice guidelines are systematically developed statements to assist important professional and patient decisions about appropriate health care for specific circumstances. The main aim of Clinical Practice Guidelines (CPGs) is to promote and support good clinical practice and inform the public about it, while taking into account the resources available. There has always been a body of opinions providing guidance to individual professionals. The novel aspect of evidence-based guidelines is both the systematic way in which they are developed and their explicit nature. CPGs must be developed using state-of-the-art methodology and be critically appraised before implementation is considered, though many use methods that are not robust or of uncertain quality or origin. Such clinical practice guidelines have several primary and secondary functions. They can be employed to support health care decisions and to provide information about cost effectiveness, be referred to in legal proceedings, and they can help to link research, education and practice. All these functions are dependent on each country's societal values and situation. The basic approaches are discussed in more detail according to the recommendations of the Council of Europe published in 2001.
Abstract: 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.
Abstract: The Guidelines International Network (G-1-N www.g-i-n.net) is a major new international initiative involving guideline-developing organisations from around the world. G-I-N seeks to improve the quality of health care by promoting systematic development of clinical practice guidelines and their application into practice. The Network now has over 45 international members, most of whom prepare evidence-based clinical practice guidelines, or actively promote the use of evidence in practice. One of the priorities of the organisation is to share evidence tables and adapt guidelines for local circumstances based on international evidence. In the longer term, guideline developers are planning to create 'living guidelines' that can be continuously updated and used by a number of different countries. A major consideration for guideline developers is how to communicate and work with information technology scientists to develop standards and protocols for the translation of these trans-national guidelines into electronic formats. To be effective, there must be formal internationally agreed standards that allow electronic guidelines to be shared and automatically updated. The Guidelines International Network will be taking a leading international role in working with designers and vendors of electronic decision support systems and tools to guarantee the integrity of guidelines when translated into electronic formats. This presentation by Catherine Marshall, Kitty Rosenbrand and Guenter Ollenschlaeger will: --explore current experiences from New Zealand, Germany and the Netherlands --identify issues from the perspective of guideline developers --make recommendations for establishing opportunities for software designers, vendors and informatics experts to collaborate with guideline developers to ensure that up to date evidence can be easily implemented and shared throughout the world.
Abstract: In order to promote the quality of health care and guidelines in Germany the German Guideline Clearinghouse (Sponsors: German Medical Association, National Association of the Statutory Health Insurance Physicians, German Hospital Federation, Associations of the Sickness Funds and the Statutory Pension Insurance) was established at the Agency for Quality in Medicine (AQuMed) in 1999. The results of the 10th Guideline Clearing Project, the Guideline Clearing Report "Breast Cancer", were published in December 2003. In a systematic search using English/German language guideline databases and literature databases (Medline, Healthstar, Embase), 16 national guidelines were identified which were in accordance to the inclusion criteria (breast cancer treatment; German or English language; published after 1992; new guideline or genuine update (no adaptation); recommended for country-wide implementation). The methodological quality of these 16 guidelines was evaluated using the appraisal instrument of the German Guideline Clearinghouse, the checklist "Methodological Quality of Clinical Practice Guidelines". A peer review of the guidelines was performed by a multidisciplinary focus group of experts (intended guideline users from clinical and ambulatory settings as well as patients). This group consented comments and recommendations for actions of health care policy makers in Germany for a German breast cancer guideline based on examples from the appraised guidelines. None of the identified guidelines contained information about all of the 24 key topics that the focus group considered to be relevant for a German national guideline. The selected exemplary text extracts from the evaluated guidelines can be used as benchmarks and example sources for the development of a national German breast cancer guideline. From the beginning, patients should be involved in the development process within a multidisciplinary team. Due to the rapid emergence of new evidence, oncology guidelines need an effective procedure for updating in order to ensure that they are able to promote health care quality by giving current recommendations based on best available evidence. International networks such as the Guidelines International Network (G-I-N) will be helpful to collect and appraise the evidence for the national guideline development groups in an effective way.
Abstract: 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.
Abstract: 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.
Abstract: One of the tasks of the Federal Co-ordinating Committee, as part of the self-governing health care system in Germany, is to develop clinical performance measures (CPMs). As these measures generally exert a strong impact on health care delivery, their methodological quality should meet the highest standards.
Abstract: 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.
Abstract: 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.
Abstract: 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.
Abstract: BACKGROUND: About 3.7% of in-house-treated patients in Switzerland, the USA and Australia are victims of treatment-related health problems which probably are related to avoidable "adverse events" in more than 50% of the occurrences. Reasons are primarily systematic incidents, e.g., organizational deficiencies in the health system and only secondarly individual mistakes. As there are no systematic studies available, it is not proven if those figures can be transferred to the German Health Care System. Here, experts anticipate up to 12.000 proven treatment errors per year. PREVENTION OF AND DEALING WITH ADVERSE EVENTS: Dedicated programs for identification and prevention of adverse events should be implemented--besides systematic quality improvement--to improve professional handling and prevention of adverse events. This consists of a) assessment of the existing problem using existing data bases and/or implementation of mandatory documentation and information routines as well as reporting systems, b) development of sanction-free reporting routines within the legal framework, c) dissemination of behavior-oriented training systems for recognition and prevention of adverse events as well as incentives for the participation in such training systems, d) implementation of automatic routines for prevention of adverse events (e.g., computer-based monitoring of ADE or computer-based reminder systems based on clinical guidelines).
Abstract: 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'.
Abstract: One of the tasks of the federal "Coordinating Committee" within Germany's self-governing health care system is to develop clinical performance measures. Since these performance measures usually exert an enormous influence on health care delivery their methodological quality should meet highest standards. The aim of our study was to develop quality requirements for clinical performance measures to be used in Germany; we did this mainly by compiling internationally published criteria. We present lists of quality requirements for clinical performance measures and performance assessment programs as well as a checklist for documenting and assessing comprehensively the methodological quality of these measures. Developing clinical performance measures by using these criteria could improve their methodological quality and promote the objectivity of performance assessment in medical care.
Abstract: 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.
Abstract: In March 2002, the German Medical Association established a National Programme for Disease Management Guidelines (DMG). This programme focuses on the development and implementation of consented key recommendations of German guidelines and evidence-based treatment recommendations for specific prioritized problems of health care issued by various organisations. Among other things, the aim is to ensure (1) that guidelines within a framework of structured care should not assume the character of directives; (2) that the evidence-based principles for structured care programmes be both scientifically accounted for and practicable and consider guidelines that have already proved to work; (3) that a consensus be obtained between the institutions of the medical self-governing bodies, the Association of the Scientific Medical Societies in Germany (AWMF) and the relevant medical societies concerning the identification, updating and implementation of the key topics of structured care programmes: (4) that the outcomes of the German Guideline Clearinghouse be taken into consideration. The methodological foundations of this programme for disease management guidelines are outlined in the following method report.
Abstract: 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.
Abstract: In a 5-day retreat at a Salzburg Seminar attended by 64 individuals from 29 countries, teams of health professionals, patient advocates, artists, reporters and social scientists adopted the guiding principle of 'nothing about me without me' and created the country of PeoplePower. Designed to shift health care from 'biomedicine' to 'infomedicine', patients and health workers throughout PeoplePower join in informed, shared decision-making and governance. Drawing, where possible, on computer-based guidance and communication technologies, patients and clinicians contribute actively to the patient record, transcripts of clinical encounters are shared, and patient education occurs primarily in the home, school and community-based organizations. Patients and clinicians jointly develop individual 'quality contracts', serving as building blocks for quality measurement and improvement systems that aggregate data, while reflecting unique attributes of individual patients and clinicians. Patients donate process and outcome data to national data banks that fuel epidemiological research and evidence-based improvement systems. In PeoplePower hospitals, constant patient and employee feedback informs quality improvement work teams of patients and health professionals. Volunteers work actively in all units, patient rooms are information centres that transform their shape and decor as needs and individual preferences dictate, and arts and humanities programmes nourish the spirit. In the community, from the earliest school days the citizenry works with health professionals to adopt responsible health behaviours. Communities join in selecting and educating health professionals and barter systems improve access to care. Finally, lay individuals partner with professionals on all local, regional and national governmental and private health agencies.
Abstract: 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.
Abstract: In order to promote quality of hypertension management in Germany, a national hypertension guidelines clearing project was initiated in 1999 by the German Guidelines Clearinghouse.
Abstract: 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.
Abstract: In the worldwide discussion about the quality and possibility to finance institutions in public health, certified quality management programs are often stressed as suitable means. It is, however, an essential requirement for a successful quality management in out-patient care to consider quality aspects in the system of reimbursement, to solve the interface problem, and to invest considerably in personnel and financing. Additionally, the fact that medical institutions increasingly take it for granted to dedicate themselves to services and customer satisfaction can pose a problem. Growing pressure due to competition within health care does encourage spreading of certified quality management systems. However, certification in industry implemented for this very same reason did not as a rule lead to a continuing improvement of quality. Against this background, it is necessary to reckon with a considerable discrepancy between certified quality management systems and actual continuing quality improvement.
Abstract: 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.
Abstract: A reliable and valid assessment of the quality of medical interventions is an indispensable prerequisite for any initiatives targeting at quality improvement in the health system. Quality indicators are well suited tools for such tasks, e.g. in the setting of a continuous monitoring. In the German health system, previous experiences concerning the use of quality indicators are limited. Available knowledge from medical services of other nations is mainly focused on the hospital sector. Therefore, it appears to be desirable to be able to provide a highly universal and standardized way for the definition of indicators of quality, enabling measurements of performance in any kind of health sector or disease treatment. Based on the demand for continuous quality monitoring in the sector of outpatient care recognized by the Central Institute of Panel Physicians, an indicator development scheme is demonstrated.
Abstract: An online-information service contianing clinical practice guidelines ("LEITLINIEN-INFO"--available via) based on similar programs from Scotland and Canada--was developed by the German Guidelines Clearinghouse (Agency for Quality in Medicine, Cologne). The service focuses on continuing medical education regarding guideline methodology and tools for critical appraisal of guidelines. It contains guideline appraisal reports developed in cooperation with the German Cochrane-Center. Special importance is given to a hyperlink collection of German and international guideline-data-bases. Backgrounds, aims, and structures of the information program are discussed.
Abstract: Within the German health system guidelines are increasing considered as a meaningful and necessary aid to decision making. In this context the effectiveness of guidelines essentially depends on their methodical quality. Because of the fact that most of the German-language guidelines introduced within the past years show obvious methodological defects, the Agency for Quality in Medicine developed within the last two years the following programme for quality-assurance and promotion of guidelines: 1. Definition of quality policies for clinical practice guidelines in Germany 2. Establishment of quality demands for guidelines 3. Methods and instruments for quality promotion of guideline programmes 4. Measures to promote and check the quality of guidelines ("German Guidelines Clearinghouse") The following article reports on background, aims, instruments, method development and acceptance of the programme.
Abstract: 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.
Abstract: 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.
Abstract: 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.
Abstract: 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.
Abstract: 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.
Abstract: The question, whether evaluation of continuing medical education (CME) is necessary, is discussed in Germany for several years. It is frequently criticized that the effects of continuing education on the medical practice and the quality of the patient care are hardly concrete. Evaluation is too often understood as a tool of external control rather than an instrument of self control and feedback for the teachers and organizers of CME events. The evaluation methods in use have many methodological shortcomings, i.e., lack of objectivity, reproducibility, feed back to the students, nearness to practice, and are therefore reason for the missing acceptance of the evaluation by physicians. Evaluation methods make sense if they contribute to efficient learning. They are supposed to aid in correctly assessing both the need and success of learning. These demands are currently most completely fulfilled by the Canadian "Maintenance of Competence Program" (MOCOMP), the applicability of MOCOMP in Germany is now proofed by the German chamber of physicians.
Abstract: Against the background of the increasing importance of quality assurance procedures for the medical profession, it was questioned to which extend the topic "quality assurance" is content in medical journals. The frequency of articles with the key word "quality assurance" in German journals for the period from 1/1992 to 9/1996 was analyzed by using a literature search on Knowledge Finder's Health Star database. Journals for the clinical physician and the physician in the medical practice, that listed more than 200 articles, were taken into account. By using the key word "quality assurance", 276 articles were found (79 in 6 interdisciplinary journals, 197 in 22 medical journals). Interdisciplinary journals published between 8 and 25 (median: 13, rank 1: Zeitschrift für ärztliche Fortbildung), medical journals between 2 and 56 (median 13, rank 1: Chirurg). This analysis leads to the conclusion that a comprehensive continuing education about medical and interdisciplinary aspects of quality assurance in medicine only by reading common German medical journals may not be sufficient.
Abstract: Medical guidelines are an important part of quality control programs. They may act on knowledge, attitude, and behaviour of physicians as well as of medical laymen and, therefore, on the quality of medical care. As guidelines have been developed and distributed in the U.S. and in other countries for decades, recommendations for the medical practice termed "guidelines" or "consensus reports" are more and more distributed in Germany, as well. However, the internationally accepted quality criteria are only rarely taken into account for such independent guidelines. This review aims to impart such quality criteria. Additionally, a structure for a standardized review and organization of guidelines is proposed.
Abstract: In the industrialized countries, nutrition-related diseases are among the most common health problems (not only in the aged, but also in the population as a whole). To date, the risks to health, and thus quality of life, of overnutrition, but in particular of a one-sided diet and malnutrition, have received too little attention in the area of medical care. Individual nutritional counseling together with a detailed identification and elimination of nutritional risks are however capable of improving the health and quality of life of the aged. The following paper provides an overview of strategies aimed at taking greater account of these measures during the provision of medical care.
Abstract: 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.
Abstract: Continuing education is seen as one of the most important instruments of medical quality assurance. Therefore, the duty of continuing medical education was put down in the professional rules of German physicians in 1976. It has been demonstrated many times that most of the physicians keep this professional duty. However, it has been repeatedly discussed whether the physician's motivation for continuing education is sufficient or whether it is necessary to introduce a compulsory proof of CME. It is analyzed in this article how the efficacy of compulsory and compulsory proof of is verified scientifically. Further, different tools are introduced which may help to admit a greater obligation. The discussion is based on data from Medline search using the keywords 'Continuing medical education' and 'Quality assurance' for the years 1984-1993. Studies reporting experiences with compulsory CME and considerations of standards were chosen. Further, presentations of the 'European Academy of Medical Education' (EAMF), Cologne March 4-March 5, 1994 as well as the publications of the German Medical Association regarding quality assurance of CME from the years 1993 to 1995 have been taken into account.
Abstract: General practitioners have been questioned by the Society of panel doctors of Bavaria about the status, deficiencies and the future focus of prevention in the medical office. The results of this questionnaire was compared to similar studies from Niedersachsen and Switzerland. From these results, conclusions should be drawn for initiatives of the medical self-administration to improve the preventive out-patient care. Written questionnaires with a semi-structured form for all of the 1067 general practitioners in the district Oberfranken of the Society of panel doctors of Bavaria. Response 33.7%. Descriptive analysis of the answers and development of a list of priorities of further education in preventive medicine. Comparison of the results with questionnaires in German language. Preventive care plays an important role in the medical practice. However, the status of prevention has currently a lower importance as it would be appropriate. This is caused by unsatisfactory honorary, lack of further education, and lack of time for an adequate consultation. It was recommended that the medical self-administration should offer more further education about preventive medicine. In all three cited studies, first of many topics, where there was a need for further education, was nutrition followed by withdrawing from smoking and protection from infections.
Abstract: For the purpose of comparison and quality control for the acquisition of the subspeciality in emergency medicine, a committee of experts in the area of emergency medicine developed the first curriculum (course book Emergency medicine) valid in all states of Germany. The requirements for the development of this curriculum were derived from the experts' experiences and from the requirements of the medical society for the quality of medical training.
Abstract: Insulin-like growth factor-I (IGF-I) is a potent protein-anabolic hormone with a glucose-lowering effect and is therefore a possible agent for treating catabolic patients. In this study we investigated the effect of recombinant human (rh) IGF-I on the interorgan flux of glucose under hypo- and normoglycemic conditions in catabolic, anaesthetized, and catheterized dogs. We administered a primed (40 micrograms/kg) continuous (1.5 micrograms.kg-1.min-1) infusion of rhIGF-I (Kabi Biopharma, Stockholm, Sweden) for 180 min together with either a saline (0.9% NaCl) or an amino acid solution (2.2 mg AA.kg-1.min-1 solution of Vamin, Kabi Nutrition, Stockholm, Sweden). RhIGF-I administration lowered plasma glucose levels for approximately 50% of the baseline (P < 0.001) and stimulated glucose uptake from skeletal muscle about twofold (P < 0.01), but did not modify glucose balances across the gut and liver. The same effects were found when infusing rhIGF-I together with AA. A co-infusion of rhIGF-I and glucose to maintain normoglycemic conditions stimulated glucose uptake from skeletal muscle by about fivefold (P < 0.001) and glucose uptake across the gut by about 50%, but reduced the hepatic glucose liberation (-65%; P < 0.01). The rhIGF-I infusion did not alter arterial lactate levels, but stimulated lactate release from skeletal muscle (P < 0.05) and lactate uptake across the liver (P < 0.05). We conclude that rhIGF-I reduces plasma glucose levels mainly by stimulating glucose uptake across skeletal muscle.(ABSTRACT TRUNCATED AT 250 WORDS)
Abstract: In order to evaluate the CME behaviour of the physicians in the state of Schleswig-Holstein, the State Society of Physicians questioned all its members (n = 10,326 and 10,698) regarding the participation in CME activities during the previous year using the same questionnaire in 1991 and 1993. Answers were obtained from 6,329/6,904 physicians where 40.2/42.2% (1991/1993) worked in free practice, 46.9 (44.6)% in hospitals, 6.2 (6.9) % in administrative and scientific institutions, 5.2 (2.9)% in various medical occupations, and 1.6 (3.3)% without medical professions. CME activities were identical in 1990 and 1992, where the study of literature was the most relevant activity (99%). Mean reading time was 5.8/5.6 hours per week (physicians in practice: 5.3/5.3 hpw, in hospital 6.4/6.6 hpw), average of read journals: 3.9/3.9 (practice: 4.3/4.3 hospital: 3.6/3.6). Video-CME was documented with 41.7/44.2% in total (practice: 50.5/52.3%-hospital: 37.2/39.9%). Regarding CME courses and conferences, traditional class-room CME was used most frequently (total: 71.9/72.6%-practice: 69.7/71%-hospital: 73.9/74.9%), followed by workshops (total: 50.3/47.9%-practice: 56.4/54.1%-hospital: 45.6/54.1%) and training in small groups (total: 16.6%-practice: 20.9/19.2%-hospital: 13.2/12%). Physicians participated in CME courses and conferences usually in the evenings (7.6/7.2 times a year), followed by halfdays courses (1.4 times), weekend courses (1.4 times) and conferences lasting several day (1.2/1.3-practice: 0.8/0.9-hospital: 1.6/1.6). This study about CME activities firstly demonstrated both the representativity of systematic questionnaires based on the rules of the medical profession, as well as the continuity of the CME behaviour in Germany. The results proof that repeated questionnaires are of little influence on the answering behaviour of physicians.(ABSTRACT TRUNCATED AT 250 WORDS)
Abstract: Additionally to the training in the hospital and in the practice, the rules for continuing education for general practise, established at the meeting of medical German physicians in 1992 demand the participation in theoretical seminars. The content and duration of these seminars is content and duration of these seminars is laid down in recommendations of the chamber of the physicians of Germany to ensure the quality of the courses. According to this, the first recommendations consists of the Course Book for General Medical Practise regarding a course of 240 hours duration. This is a nation-wide standardized curriculum which was accepted from all German chambers of physicians as the basis of the further education in family medicine. The standardization and the structuring of the content, goals, and methods of teaching and learning as well as the organization of the seminars, the working materials for the teachers, regular training for the presenters and teachers, methods for a nation-wide evaluation of the seminars, and independence from commercial interests are the features to ensure the quality of the courses.
Abstract: In HIV-infected patients, the outcome of counselling as the first step of a nutritional intervention programme was evaluated, in order to identify clinical and nutritional predictors for its efficacy. 75 HIV-infected patients were investigated, most with advanced disease. Nutritional status was determined by body weight, bioelectrical impedance and 7-day food intake record. Prior mean weight loss was 10% (range = +4% to -31%). Counselling facilitated weight gain in 40 75 patients (1-4 months later, overall mean difference +1.4 +/- 6.2%) and in 14 34 patients (8-11 months later, overall mean difference -1.4 +/- 9.0%). Weight changes correlated with changes in body cell mass (r(2) = .69, p < .001) and in body fat (r(2) = .29, p < 0.05), but not extracellular mass. Underlying conditions such as AIDS definition, fever, and diarrhoea correlated to prior weight loss (p < .001) but not to the outcome of counselling. Low energy intake (before counselling, < 31.5 kcal/kg) did not correlate to prior weight loss but it predicted further weight loss (p < 0.05 towards normal intake). High energy intake (> 38.5 kcal/kg) correlated (p < 0.05) with more prior weight loss but not with further weight changes. Nutritional counselling may be an effective first-line intervention for malnourished HIV infected patients. More than half of patients gain weight without other nutritional treatment. Whereas the severity of malnutrition is influenced by the underlying disease, fever, and diarrhoea, the course of weight change after nutritional intervention is not. Counselling may reduce the nutritional impact of these risk factors. In patients with low spontaneous intake, efficacy of counselling alone is limited, but it may help to identify those who require more invasive nutritional treatment.
Abstract: The German statutory health insurance bodies are legally obliged to support health promotion of the assured, as stipulated by German social legislation since 1988. An analysis was performed covering a period of 5 years (1986-1990) in respect of all health-promoting and preventive measures carried out by a local so-called "Allgemeine Ortskrankenkasse (= AOK)" looking after 170,000 insured persons, to find out the impact of the new legislation on the practice of that particular local insurance body. During the period under report no changes in activities were recorded that would be worth mentioning. Although expenditure for prevention rose by 50%, it was nevertheless impossible to administer preventive measures to all the insured persons throughout the area since the total amount reserved for this purpose was only 0.42% of the overall expenditure. A major portion of the documented measures such as consultation on foods, health-promoting sports, getting rid of the smoking habit, social counselling, anti-stress training courses and the like were not performed for primary prevention but on subjects who were already sick (diabetics, cardiovascular patients, patients suffering from diseases of the locomotor apparatus). Definite statements on the quality or success of the measures were possible in selected cases only. The results of the study prompted organisational improvements in that particular insurance body. Since their financial resources are limited, these bodies should shift the emphasis of their expert possibilities in prevention to on-target care of high-risk groups and to the training of multiplicators.
Abstract: Supplementation with polymeric formula diet was evaluated as second step of a nutritional intervention program for malnourished, but otherwise clinically stable HIV-infected patients.
Abstract: Malnutrition and cachexia are characteristic symptoms of human immunodeficiency virus (HIV)-1 infection and AIDS. To identify risk situations that might affect nutritional behavior and status and to evaluate the therapeutic effect of an intensified oral nutritional intervention, we analyzed 81 consecutively treated homosexual HIV-infected outpatients with malnutrition retrospectively and could follow the outcome of a nutritional intervention prospectively in 54 of them. Nutritional therapy was ineffective for only 5 of the 54 patients; constant weight loss could be stopped in 31 of the patients, and 18 patients could even gain weight. We suggest intensified oral nutritional intervention should be an integral part of the treatment of HIV-infected patients to prevent or treat malnutrition.
Abstract: Nutrition-related diseases are the primary health problem, not only of the aged, but also of the whole population in industrialized countries. While the health risks of overnutrition are well considered in prevention and medical care, the consequences of malnutrition are often disregarded. Nutritional counseling, early diagnosis, and therapy of nutritional risk factors are able to improve quality of life and prognosis of the aged and should be performed more intensively in medical care.
Abstract: A total of 29 patients with acute leukaemia were prospectively randomized before starting cytostatic treatment to be nourished either with intensified oral nutrition (intervention group) or ad libitum nutritional intake during the whole tumour therapy (median 22 weeks). All received menus of free choice (daily offer of 1.0-2.0 g protein, 30-50 kcal kg-1 body weight (BW)). Beyond this, intervention patients received nutrition education, daily visits by the dietician and record of food intake, as well as a weekly assessment of subjective well-being (linear analogue self assessment 'LASA'). From the LASA items, the factors: 'malaise', 'psychological distress', 'therapy side-effects' were extracted by principal component analysis, and correlated to nutrient intake and nutritional status. At the end of antineoplastic induction therapy, after continuous hospitalization of 10 weeks (median), 31.3% of the controls had regained their initial nutritional status, and 68.8% of the intervention group. Mean daily energy intake was 23.2 kcal kg-1 BW during weeks with weight loss (constant weight: 30.9, weight gain: 39.3 kcal kg-1 BW). Nutritional behaviour correlated with subjective well-being, low intake with complaints of tumour treatment side effects and weight loss with malaise.
Abstract: We report for the first time the concentrations of free amino acids in human intestinal biopsies obtained by routinely performed endoscopy. We studied 15 medical patients with no changes of the mucosa and six HIV-infected persons with duodenitis. The mean (and SD) sum of all amino acids, taurine excepted, was 61.9 (5.4) mmol/kg dry weight in duodenal biopsies of HIV-negative subjects (n = 11) and 82.9 (0.6) mmol/kg in colonic specimens: 50% (44%) of the total (minus taurine) consisted of aspartate and glutamate and 14% (12%), of the essential amino acids. The relative amino acid pattern in duodenum and colon differed completely from that for muscle: aspartate was fourfold higher; glutamate, phenylalanine, glycine, valine, leucine, and isoleucine were about twofold higher. In contrast, glutamine amounted only to 4% (duodenum) to 14% (colon) of muscle glutamine. In duodenal biopsies of the HIV-infected persons, we found significantly (P less than 0.01, except glutamine: P less than 0.025) increased concentrations of glutamate (24.1 vs 17 mmol/kg dry weight), ornithine (1.4 vs 0.4), valine (2.2 vs 1.7), and glutamine.
Abstract: Even though cognitive education programs are essential for the treatment of diabetics, long term efficacy often seems to be poor. Problems of coping with illness could be the reason for a lack of transfer of knowledge into daily practice. Small discussion groups with the aim of modifying attitudes towards illness might be a good possibility to face this problem. 54 IDDM, HbA1 10.7 +/- 2.3% (median +/- SD) absolved our 5-day education program for outpatients, in which daily group sessions (90 min), supervised by a group-therapist, were integrated. Follow-up sessions took place after 1, 4 and 8 months. The efficacy was measured by HbA1 and different questionnaires on diabetologic knowledge, life satisfaction (FLZ) and complaints (BL). 4 months after the education program HbA1 had decreased to 9.0 (median +/- SD) and remained stable within small range during the rest of the study-period. Diabetologic knowledge increased from 70% (median +/- SD) to 87% (median +/- SD) 1 month after the education and remained stable during the rest of the study-period. Complaints decreased within one month from a level above average somatic illness to the normal level for healthy subjects. However, in regard to their life satisfaction our patients were significantly less satisfied concerning their health, whereas family life and friendship were declared to be more satisfying (after 8 months). We believe that more intensive communication in the family (encouraged by the group-therapy) and parallel more critical attitudes towards illness lead to this results. As basic elements for long term modification of illness behaviour these emotional aspects seem to be essential.
Abstract: In 1981, the intensified insulin therapy for achievement of euglycaemia in pregnant diabetics was introduced at the University Department of Obstetrics and Gynaecology in Cologne. This study compares the results of 112 pregnancies in women with overt diabetes monitored before (1971-1980) or after (1981-1988) changing the therapeutic regimen. In the period from 1981 to 1988, the proportion of euglycaemic patients (preconceptionally 19%, before delivery 79%) was clearly higher than from 1971 to 1980 (n = 42; 7% and 9%, respectively). The tight blood glucose control resulted in a doubling of hypoglycaemic episodes during pregnancy. The proportion of preterm deliveries was reduced from 47% to 24%. The rate of caesarean sections was nearly constant (1971-1980: 38%, 1981-1988: 34%). The marked success of therapy was the decrease of perinatal mortality from 20.9% to 2.9%. The perinatal morbidity also diminished, as shown by the decreasing rates (30-90%) of foetopathy, macrosomy, respiratory distress syndrome, birth trauma, hypoglycaemia, hypocalcaemia and polycythaemia. The malformation rate, however, remained high (1971-1980 = 7%, 1981-1988 = 11%). The results demonstrate the necessity of a strict blood glucose control during pregnancy, beginning before the time of conception.
Abstract: Until now, recommendations for nutrition therapy of HIV-infected subjects can only be regarded as preliminary, because of the lack of scientific results regarding the interactions between HIV-infection and nutrition. HIV-infected patients have a high risk to become malnourished during the course of the disease, as a consequence of multiple pathogenetic factors--similar to the nutritional problems of tumor patients. At the moment, the following procedure is recommended in order to treat or prevent HIV-associated malnutrition: The nutritional status and history should be assessed in each HIV-positive subject as early as possible. Independent of the actual nutritional status, each patient should obtain a nutrition education. A continuous nutrition therapy becomes necessary in the case of evident or imminent malnutrition. Nutrients should be applied by oral access as long as possible. But especially for patients with opportunistic infections of the GI-tract accompanied by malabsorption, total parenteral nutrition may be the only effective way of nutrition.
Abstract: Da es zum jetzigen Zeitpunkt noch an umfassenden wissenschaftlichen Resultaten zu den Beziehungen zwischen HIV-Infektion bzw. AIDS und der Ernährung fehlt, können Ernährungsempfehlungen für HIV-Infizierte bisher nur aufgrund der Erfahrungen bei anderen chronischen Erkrankungen erstellt werden. Da AIDS in besonders hohem Maβe mit dem Risiko der Mangelernährung einhergeht, empfiehlt sich im Augenblick folgendes Vorgehen: Von jedem HIV-Infizierten sollte zum Zeitpunkt der Diagnose durch eine Fachkraft eine vollständige Emährungserhebung (inkl. Anamnese) durchgeführt werden, um rechtzeitig ein Ernähmngsrisiko erfassen zu können. Jeder HIV-Infizierte sollte eine Ernährungsberatung erhalten, unabhängig von seinem Ernährungszustand und -verhalten. Bei drohender oder vorhandener Mangelernährung sollte eine regelmäβige Betreuung durch eine Fachkraft erfolgen, welche für die Ernährungstherapie verantwortlich ist und nötigenfalls die praktische Versorgung mit Nahrung mitorganisiert. Die praktische Durchführung der Ernährungstherapie erfolgt stufenweise, wie z.B. bei Tumorpatienten üblich; orale Ernährung sollte so lange wie möglich verabreicht werden. Ernährungsbetreuung muβ integraler Bestandteil der Behandlungskonzepte des HIV-Infizierten sein.
Abstract: In a recent study we showed that the growth behavior of a hematopoietic cell line (K 562) in culture was the same when using glutamine-containing dipeptides or glutamine as substrate. In this article we study the growth behavior of different tumor cells, originating from the hematopoietic system (K 562), stomach (Kato III), pancreas (Panc 1), and breast (T 47 D), to test the biological activity as preclinical in vitro screening system. We compared L-glutamine (GLN), N-acetyl-L-glutamine (ACE-GLN), L-alanyl-L-glutamine (ALA-GLN), and glycyl-L-glutamine (GLY-GLN). Cell proliferation was measured with the incorporation of [3H] thymidine or the MTT assay (cleavage of 3-(4,5-dimethyldiazol-2-yl)-2-5-diphenyl tetrazolium bromide by mitochondria). In all investigated cell types cell growth was stimulated when using glutamine-containing dipeptides or ACE-GLN instead of a glutamine-free media (not significant for T 47 D). However, GLN or ALA-GLN was advantageous to GLY-GLN or ACE-GLN when measuring cell proliferation with the MTT-assay up to 72 hours. However, alanylglutamine does not enhance proliferation, compared with free glutamine.
Abstract: Recently a relationship has been postulated between lowered intracellular glutamine concentrations in the skeletal muscle and the rate of protein synthesis. We investigated the effect of 48 hours of parenteral nutrition supplemented with a solution containing glutamine in free or dipeptide form (alanylglutamine or glycylglutamine) on the intracellular glutamine pool in skeletal muscle and on the hind limb exchange of glutamine in dogs with sepsis after surgery. Before surgery, dogs were fasted for 48 hours. We used glutamine dipeptides as sources because they remain stable in an aqueous solution. Nutrition solutions were isocaloric (17.8 kcal/kg body weight/day on day 1 and 35.6 kcal/kg on day 2) and isonitrogenous (0.33 gm nitrogen/kg body weight/day), providing 2.6 mmol/kg body weight/day as glutamine source. During starvation, muscular free glutamine levels decreased by 41% to 10.4 mmol/L (p less than 0.001). On the second postoperative day the dogs had lowered plasma protein levels, a sharp drop in platelet count, an increase in the leukocyte count, and positive blood cultures. None of the solutions investigated in this study was effective in repleting the glutamine pool during 2 days of postoperative nutrition (11 +/- 2.0 mmol/L without glutamine, 10.3 +/- 2.2 mmol/L with glutamine plus alanine, 9.9 +/- 1.6 mmol/L with alanylglutamine, 7.5 +/- 1.1 mmol/L with glutamine plus glycine, and 7.2 +/- 1.2 mmol/L with glycylglutamine, respectively). The release of glutamine from the hindquarter was 631 +/- 38 nmol/kg body weight/min in the control group and decreased significantly in dogs receiving alanylglutamine (13.5 +/- 45 nmol/kg body weight/min; p less than 0.001) or the constituent amino acids (265 +/- 66 nmol/kg body weight/min; p less than 0.01) but was unchanged in dogs receiving glycylglutamine or glutamine plus glycine. We conclude that the duration and dosage of glutamine administration (equivalent to 26 gm glutamine per day in a patient weighing 70 kg) used in this study are not sufficient to restore glutamine deficiency of the skeletal muscle in the depleted state.
Abstract: Adrenal tumours had been discovered incidentally (since 1981) in 32 patients (23 females and nine males; mean age 54 [25-73] years) who had had computed tomography (CT) or ultrasonography for other reasons: none had a history or symptoms of such tumour. Tumours were bilateral in eight, right or left-sided in 12 each: all had been confirmed by CT. Average tumour size was 3 cm (1-9 cm). Three patients had cortisol-producing adrenal tumours, and there was one benign phaeochromocytoma (abnormally high adrenaline and noradrenaline excretion). Fine-needle biopsies in two patients revealed a benign histology. An adrenalectomy was performed in eight patients (the one phaeochromocytoma, six adenomas and one ganglioneuroma). Follow-up CT in 11 of the non-operated patients 6-48 months later (mean of 14 months) did not demonstrate any increase in tumour size so that a waiting attitude seems justified: benign tumours are clearly much more frequent than malignant ones. However, if the tumour diameter is greater than 6 cm, an adrenalectomy is indicated because of the danger of malignancy.
Abstract: Diabetic patients under multiple injection insulin therapy (i.e., intensified insulin therapy, IIT) usually start this treatment during hospitalization. We report here on the logistics, efficacy, and safety of IIT, started in outpatients. Over 8 months, 52 type I and type II diabetics were followed up whose insulin regimens consecutively had been changed from conventional therapy to IIT. Two different IIT strategies were compared: free mixtures of regular and intermediate (12 hrs)-acting insulin versus the basal and prandial insulin treatment with preprandial injections of regular insulin, and ultralente (24 hrs-acting) or intermediate insulin for the basal demand. After 8 months HbA1 levels had decreased from 10.6% +/- 2.4% to 8.0% +/- 1.3% (mean +/- SD). There was no difference between the two regimens with respect to metabolic control; but type II patients maintained the lowered HbA1 levels better than type I patients. Only two patients were hospitalized during the follow-up time because of severe hypoglycemia. An increase of body weight due to the diet liberalization during IIT became a problem in one-third of the patients. Our results suggest that outpatient initiation of IIT is safe and efficacious with respect to near-normoglycemic control. Weight control may become a problem in IIT patients.
Abstract: Nutritional assessment has not yet been established as integral part of basic clinical diagnostic procedures everywhere, eventhough the prognostic relevance of malnutrition is well known. One of the reasons is the lack of nutritional indicators, which are specific of and sensitive for changes of the nutritional status on the one hand, and routinely analyzed on the other. We report on the utility of serum cholinesterase, which has the shortest half-life of all plasma proteins, to identify malnourished patients. 54 internal inpatients with malignant diseases or in septic state were followed up prospectively with respect to courses of cholinesterase (CHE), albumin (ALB), transferrin (TRA), and body weight over periods of 4 weeks. A correct correlation to malnutrition was defined as plasma concentrations less than reference ranges or continuous concentr. fall greater than 10%. Based on 132 observations (65 with continuous weight loss, mean: -5.5% of original w.; 54 w. gain, mean +4.6%, 13 constant w.), changes of CHE had the highest correlation to weight changes (r = 0.79, p less than 0.001), compared to the courses of TRA- or ALB-levels (r = 0.65/0.68). Incorrect positive results (conc. fall or conc. less than ref. range without weight loss): absolute levels - CHE 4%, ALB 4%, TRA 22%; conc. courses - CHE 0%, ALB 0%, TRA 6%. Incorrect negative: absolute c. - CHE 63%, ALB 30%, TRA 28%; courses - CHE 15%, ALB 19%, TRA 17%. The common determination of CHE and ALB-courses allowed a correct identification of malnutrition in 96% of all observations, with the same result as the courses of ALB + TRA.(ABSTRACT TRUNCATED AT 250 WORDS)
Abstract: Eleven Human Immunodeficiency Virus 1 (HIV1)-infected patients (10 male, 1 female; age 23-51 years (median 36); 10 male homosexuals, 1 IV drug abuser; WR3 1 patient, WR5 5, WR6 5) with intestinal Cytomegalovirus (CMV)-manifestations were compared with a group of 78 HIV1-infected patients in respect to their clinical, immunological and virus-serological data and the results of the histological and microbiological examination of endoscopically obtained biopsies. No differences were observed on age, sex, risk of infection, stage and immunological status. Bloody diarrhea was most important in discriminating CMV-colitis and non-CMV-related intestinal manifestations. Dysphagia and other symptoms occurring in patients with CMV-esophagitis were not able to predict CMV-esophagitis specifically. 6 of 11 patients with serological findings consistent with an active CMV-infection had no detectable CMV-manifestations; 6 of 11 patients with intestinal CMV-manifestations did not show serological findings suggestive of active CMV-infection. Ulcerative alternations of intestinal mucosa represent the most powerful indicator of intestinal CMV-disease in endoscopical examination. Only in two patients, ulcerative alterations were seen without diagnosis of CMV-disease being established. CMV was isolated in one of 11 patients, in two patients CMV was isolated from biopsies of unchanged mucosa. Simultaneous infection by HSV and CMV was detected in three patients, in one patient in the same localisation. Histology revealed inclusion bodies in 8 of 11 patients with intestinal CMV-disease, in no case inclusion bodies were seen without CMV-disease.
Abstract: Aggressive oncological chemotherapy often impairs the nutritional status of tumor patients. To evaluate the pathogenetic mechanisms, food intake in 13 cancer patients was investigated in correlation with nitrogen losses, N balances, muscle wasting, and weight course, during cytostatic therapy. Median daily N and energy intakes were reduced only in patients with weight loss [0.55 g protein, 16.5 kcal/kg ideal body wt (IBW)]. Patients with constant weight had the same intake as control subjects (1.27 g protein, 37.2 kcal IBW). N balances and creatinine height index (CHI) correlated with daily nutrient intake. Fecal N excretions did not correlate with urinary losses; there was no excess of fecal N loss because of cytostatic treatment. The impairment of cancer patients' nutritional status seems to depend primarily on the decrease of spontaneous oral intake as a consequence of the side effects of tumor therapy. Changes in CHI, compared before and after chemotherapy, indicated muscle wasting of weight-losing patients.
Abstract: Elevated plasma levels of glutamate (GLU) have been reported to occur in patients with malignancies and other immunodeficiency syndromes (IDS). To evaluate, whether GLU is useful as prognostic indicator, the plasma concentrations were determined in patients with colorectal carcinoma (CRC), with breast cancer (BRC), and with HIV-infection (HIV). The results were correlated with the disease-stages, and compared with data obtained from patients with benign diseases of the same organ, as well as from sex-matched healthy volunteers. GLU concentrations (volunteers: 27.4 +/- 17.6 mumol/l) were elevated in all BRC patients (range of mean values: 53.5-83.2 mumol/l), in CRC patients with T2-T4-tumours (means: 46.8-85.9), and in HIV+ patients of stage WR 5, 6 (means: 53.9-69.7 mumol/l). All CRC- and BRC-patients with metastases showed highly significant elevations of GLU concentrations (p less than 0.001), but there were no direct correlations between disease stages and GLU levels. Pre-operative patients with benign diseases (diverticulitis, adenoma = GID; and mastopathy = MTP) showed increased GLU levels, which were comparable to those of the tumour patients. The glutamine/GLU ratios (volunteers: 19.3 +/- 15.0) were decreased only in HIV-WR 6 (7.6 +/- 2.1), and BRC-stage 4 (8.0 +/- 1.7). From these results we deduce that the plasma GLU concentrations do not allow a discrimination either between patients with malignancies and without, and between persons of different disease stages.
Abstract: The anabolic utilization of nutrients can be modified or impaired due to the influence of a malignant tumor in animals and in humans. Tumor-associated malnutrition as well as the side-effects of several antineoplastic regimens may induce mucosal atrophy, and by this the intestinal absorption of nutrients becomes impaired. Intensified nutrition therapy by oral, enteral or parenteral access is able to maintain or improve the nutritional status of tumor patients. The daily need of substrates can be enhanced as a consequence of the tumor-induced stimulation of proteolysis, gluconeogenesis, hepatic protein synthesis, as well as of an impaired protein metabolism. In the last years, a lot of antimetabolites have been tested for antineoplastic treatment. So far, there is no drug of this kind known, which reduces tumor growth without harm for the tumor-bearing host.
Abstract: We investigated the influence of leupeptin (LP) intraperitoneal injection (40 mumol/2 days) on protein and amino-acid metabolism of septic rats (cecal ligation). All septic rats lost weight (-17 +/- 4 g), which was not prevented by LP administration (-24 +/- 1.8 g, n.s.). LP injection evoked weight loss even in normal rats (p less than 0.05 vs controls). Weight loss was accompanied by enhanced urinary nitrogen losses in all three groups. LP reduced food intake for 47% in control rats. Cecal ligation, and also the administration of LP, led to alterations of amino-acid metabolism. The most important changes were found in muscle free amino-acid concentrations with highly decreased levels of free glutamine. A glutamine deficiency is known to be related to a decreased rate of protein synthesis. The proteolytic rate in incubated soleus muscle was increased for 11.5% and even higher in LP-treated septic rats (+22%). It is concluded that the administration of LP cannot reverse protein catabolism in sepsis--possibly because LP does not influence those enzymes or proteases involved in tissue loss, or LP is inactivated by enzymes in rat tissues.
Abstract: The instability of the amino acid glutamine prompted us to investigate substitute compounds appropriate for culture conditions. The effect of two glutamine-containing dipeptides, alanylglutamine (Ala-Gln) and glycylglutamine (Gly-Gln), on the growth behavior of a hematopoietic cell line in culture (K562) was investigated. Growth rates and [3H]thymidine incorporation rates of cells cultivated in sterile-filtrated media, containing glutamine (Gln) or Ala-Gln or Gly-Gln, were not statistically different. Although heart-sterilization of media containing Gln caused approximately 95% decomposition of the Gln, both dipeptides remained unaltered. Consequently, cell growth was drastically decreased when autoclaved free Gln-containing media were used, but growth was unaffected in the presence of autoclaved dipeptides. Both Ala-Gln and Gly-Gln have an advantage over free Gln as growth factors for cell culture due to the stability of the dipeptides during both autoclaving and storage; the biological activity, however, is comparable.
Abstract: 1. The present study examined the effect of an infusion of the dipeptide alanylglutamine or of the corresponding amino acids alanine and glutamine in equimolar amounts (10 mumol min-1 kg-1) on the canine hindlimb exchange of alanine and glutamine in the post-operative anaesthetized dog. In contrast to glutamine, the dipeptide alanylglutamine is stable in aqueous solution and therefore would be a suitable substrate for parenteral nutrition. 2. The infusion of alanylglutamine increased (a) the arterial concentration of alanylglutamine to a plateau level (120 +/- 9.5 mumol/l, mean +/- SEM) 20 min after start of the infusion, (b) the mean arterial alanine concentration from 761 +/- 42 to a plateau of 1500-1700 mumol/l (P greater than 0.01) and (c) the arterial glutamine concentration from 407 +/- 51 to a plateau of 1050-1500 mumol/l (P greater than 0.01). Alanine and glutamine levels were slightly higher (14% and 26%, respectively, NS) in the group receiving the equimolar amount of alanine and glutamine. 3. Infusion of alanylglutamine for 1 h abolished the net efflux of glutamine (from -0.80 +/- 0.1 to -0.03 +/- 0.2 mumol min-1 kg-1; P greater than 0.05) and invoked a net influx of alanine (from -0.50 +/- 0.19 to +0.27 +/- 0.14 mumol min-1 kg-1; P greater than 0.01). These changes were similar to those achieved when the two amino acids were infused. 4. This study demonstrates that during short-term administration of alanylglutamine or of the corresponding amino acids the nitrogen release from the hindlimb of the anaesthetized post-operative dog via alanine and glutamine is reduced.
Abstract: We measured the free amino acids in plasma of 58 patients with HIV infection and in six persons in the risk group. The HIV+ patients had significantly increased concentrations of arginine, phenylalanine, and glutamate in comparison with both age- and sex-matched controls and the members of the risk group. Glutamate concentrations increased only in an advanced stage of the disease (WR 5 and 6 of the Walter Reed staging classification), whereas arginine and phenylalanine increased independently of the stage. There was no correlation between the amino acid concentrations and the number of T4 and T8 lymphocytes, the sedimentation rate, and the existence or absence of Kaposi's sarcoma. The amino acid pattern of HIV-infected persons is similar to that of cancer patients or those with other immune deficiencies.
Abstract: Several side-effects of asparaginase therapy have been said to be a consequence of the glutaminase activity of Escherichia coli asparaginase, especially the deleterious influence on the liver function. We report here the drug-induced impairments of asparagine and glutamine metabolism in correlation to concentrations changes of plasma proteins, synthesized in the liver, in patients with acute lymphatic leukaemia. One hour after asparaginase application, plasma glutamine decreased to 5% (0-39%: median, range) of the initial values, with a subsequent rise to concentrations slightly lower than those prior to therapy. During the 14 days of drug application the fasting plasma concentrations of glutamine fell to a median of 63% of the pre-therapeutic levels, indicating a depletion of the glutamine pools. Two days after the end of asparaginase application, in one patient the glutamine concentrations increased to the pre-therapeutic range. Plasma concentrations of fibrinogen and antithrombin III decreased to 46% and 56%, respectively, of the initial values, with a slight increase 2 days after the end of therapy. The changes of plasma protein concentrations followed the course of plasma glutamine and asparagine. From that we deduce that the hepatic synthesis of the plasma proteins might be influenced by asparagine and glutamine depletion as a consequence of the therapy with E. coli asparaginase.
Abstract: In 10 patients with heavily pretreated Hodgkin's disease (stage IVA or IVB) a third-line salvage therapy consisting of CCNU, etoposide and chlorambucil (CECh) was tested. All patients were resistant to both COPP and ABVD. Acceptance and tolerance of CECh were very satisfactory. The observed response rate (3 complete remissions and 4 partial remissions) is encouraging. The survival time after CECh therapy is in excess of 32 months (complete remission) and 15 months (partial remission). The main possible adverse effect is a prolonged myelosuppression. The CECh therapy is an effective alternative chemotherapy in patients resistant to both COPP and ABVD, moderately toxic, easy to administer and well tolerated in heavily pretreated patients.
Abstract: The nutritional consequences of oncologic surgery, cytostatic treatment, and of radiotherapy are reviewed with special respect to gastrointestinal function as well as nutrient assimilation and utilization. The different types of nutritional intervention, which may be necessary to overcome the treatment-induced malnutrition are discussed.
Abstract: Studies in anorectic tumor-bearing rats indicate that anorexia is correlated to imbalances of neutral amino acids in blood and CNS. Consequently plasma amino acids of patients with neoplastic and non-neoplastic internal diseases were studied during phases of anorexia; special regard was given to the precursors of dopamine and serotonin. Anorectic patients were compared to non-anorectic patients with neoplasia. During anorexia, plasma levels of valine and leucine and hence the ratio of the molar concentrations of Val + Leu + Ile/Phe + Tyr were significantly decreased in each anorectic patient as compared to non-anorectic patients whose ratios were always within the normal ranges. As aromatic and branched-chain amino acids compete for penetration of the blood brain barrier, the decrease of the amino acid ratio may induce a raised flux of phenylalanine and tyrosine into the CNS which results in an increased activation of dopaminergic neurons--known to cause anorexia.
Abstract: The kinetics of plasma proteins with short half-life during stress-metabolism in patients after myocardial infarction with and without clinical complications and after angina pectoris were compared. The acute-phase proteins alpha1-antitrypsin, C-reactive protein (CRP), fibrinogen, haptoglobin, and the transport proteins prealbumin and transferrin were analyzed with the method of radial immunodiffusion. Whereas angina pectoris doesn't influence the protein kinetics, one can recognize after myocardial infarction a continuous increase of the acute-phase proteins to maxima between the 3rd and 5th day after the attack. Parallel to these changes, the transport proteins decrease with subsequent increase. The changes, which are similar to those seen after surgical trauma, are dependent on the severity of illness, and can be used as prognostic parameters. During stress metabolism, the concentrations of the proteins depending on nutrition, prealbumin and transferrin, are modified by the type and severity of stress, and by nutritional influences. The mechanisms of these changes and the consequences for their use as diagnostic parameters are discussed.
