Kompetenznetze In Der Medizin

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Forschung für den Menschen

Kompetenznetze in der Medizin

GEFÖRDERT VOM

www.kompetenznetze-medizin.de

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IMPRESSUM Forum Öffentlichkeitsarbeit der Kompetenznetze in der Medizin im TMF e.V., Geschäftsstelle Neustädtische Kirchstrasse 6, 10117 Berlin Redaktion: Frau Antje Schütt (Kompetenznetze in der Medizin), Frau Regina Becker (TMF e.V.)

Wesentliche Teile der Darstellung (Auszüge der Broschüre Kompetenznetze.de) sind mit freundlicher Genehmigung des VDI veröffentlicht.

Druck/Verarbeitung: Siebel Druck und Grafik, Lindlar Bonn, Juli 2004

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Forschung für den Menschen

Kompetenznetze in der Medizin

© Siemens AG, München / Berlin

www.kompetenznetze.de > Fields of Innovation > Medicine

Medicine Networks of Competence

b Acute and Chronic Leukemias © Siemens AG, München / Berlin

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c Atrial Fibrillation

Efficient and qualitatively outstanding health research is a major pre-requisite towards ensuring progress in medical care.

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This is why, in 1999, the Federal Ministry for Education and Research (BMBF) initiated the establishment of medical ‘Competence Networks‘ as a measure to promote disease-oriented interdisciplinary innovative research and the transfer of research results into practice.

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By 2003, the total number of funded networks had increased to 17. Doctors in hospitals and private practice, scientists, clinicians, patient organizations and regulatory bodies have joined forces to enable multidisciplinary co-operative medical research. In being specifically oriented towards diseases with a high socio-economic impact, these networks focus on a two-pronged approach, directed at innovation-oriented research and the transfer of research results into practical and economically viable solutions, with the ambitious goal of integrating existing nationwide expertise. The networks have attracted considerable attention nationally and internationally over the last 5 years, as illustrated by the vast numbers of research publications, meta analyses, newly-established guidelines and quality assurance measures arising from the BMBF-funded initiative. The network centers have therefore created an excellent infrastructure through which the above mentioned aims can be achieved. Measures include: • the provision of common services, such as reference diagnosis of relevant pathogens or remote expert evaluation of tissue samples. • setting up and monitoring of multicenter clinical studies, providing the critical mass for either large scale studies or the rapid identification of

patients with special characteristics • providing centrally located material and data bases for specific research projects • uniform standards for data entry, storage and evaluation in accordance with data protection laws • the formation of nationwide structures within and between networks to enable efficient communication between network members, the scientific community, patients and industry partners • enhancement of visibility through dedicated network homepages (kompetenznetze-medizin.de), newsletters and internet-based information targeting the general public, specialist interest and knowledgetransfer. The TMF e.V. (Telematikplattform für medizinische Forschungsnetze; www.tmf-ev.de) was launched as an umbrella organization for clinical research networks in order to support and promote best practice in interdisciplinary health care research. This organization not only provides a platform for technical information and communication, but also promotes the creation of standard procedures or guidelines using a collaborative approach. There have been significant achievements as a result of the formation of the TMF; nationally-supported data protection guidelines, standardized patient consent forms and clearly defined procedures for software use in clinical studies. The main priority when establishing such common procedures has been to set standards of the highest level in accordance with Good Clinical Practice (GCP) and relevant legal requirements.

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Page 9 Brain-Net Page 10 CAPNETZ – Community Acquired Pneumonia Page 11 Cogenital Heart Defects Page 12 Dementia Page 13 Depression and Suicidality Page 14 Heart Failure Page 15 HEP-NET – Hepatitis Page 16 HIV/AIDS Page 17 Inflammatory Bowel Diseases Page 18 Malignant Lymphomas Page 19 Parkinson's Disease Page 20 Pediatric Oncology and Hematology Page 21 Rheumatology Page 22 Schizophrenia Page 23 SepNet – Sepsis Page 24 Stroke Page 25

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TMF – a Network for Networks Professionalism and Efficiency for Clinical Research The “Telematikplattform für Medizinische Forschungsnetze” (TMF) is a meta-organisation which works towards the improvement of research and procedures in a network environment. Telematics solutions but also quality assurance and new workflows are subjects of interest for the clinical research networks. Scientists from all member networks of the TMF collaborate in thematic working groups on the development of new strategies for efficient high-quality clinical research. In acknowledging the need for enhanced co-operative research in medicine, the German Federal Ministry of Education and Research (Bundesministerium für Bildung und Forschung, BMBF) established in 1999 a grant for so-called Competence Networks in Medicine. Within such a competence network, clinical research is not limited to a single organisation or university but is widespread from large research laboratories and medical departments to mutual interaction with general practitioners. For this type of ‘cooperative research to work’, scientists, medical doctors and clinical researchers communicate and exchange data with physicians throughout Germany and even beyond, a mission oriented task requiring new methodology and approaches. The challenges arising from these changes apply to all clinical research networks. Therefore, the BMBF in co-operation with the funded Competence Networks in Medicine and related interconnection projects established the TMF as a platform to tackle the common challenges. This new umbrella network – a network for networks – is a forum directed towards intense information exchange and the realisation of joint projects. Such projects are mission oriented aiming to improve existing working procedures and the quality of research within the member networks.

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Focus of Activities All networks are dealing with data protection regulations, organisation and data flow. In addition, the networks address aspects of licensing and exploitation in view of long-term perspectives. Since a variety of qualitatively different problems arise from these issues it is the task of the TMF to actively support the networks in finding solutions by providing specific recommendations, codes of practice and new tools for research. A major focus of the TMF is also quality assurance and quality management as indispensable tasks in disease oriented clinical research. Technical Solutions By the analysis of individual requirements and creation of respective user profiles TMF assists to identify applicable technical solutions out of the multiple research applications on the market. In case a telematic solution for a common problem of the research networks is not available, the TMF also initiates corresponding developments. Administrative Solutions The TMF represents its members in negotiations with industry and the German government as well as with national institutions such as the data protection officials. As a joint organisation of clinical research networks, the TMF can effectively communicate the demands of clinical research. At the same time it serves as a contact point for these institutions into networked research.

As major progress, a national data protection concept for the storage of patient related data has been developed by the TMF in cooperation with the data protection officials from each German state. Here paradigms have been created that demonstrate how to handle patient related data and nonetheless meet the requirements of privacy in a clinical as well as a scientific context. These paradigms have been nation-wide accepted. Thus, by implementing the TMF recommendations, a German clinical research network which utilizes patient data is enabled to quickly obtain the necessary data protection approval. Example: Informed Consent An example for general logistic support is the standardized practice for the informed consent of patients. To enrol patients in clinical trials, information about the trial and its possible consequences must be conveyed. Written consent is mandatory. For each trial, it is necessary to design a comprehensible information sheet explaining the purpose of the trial and the handling of personal data. A survey among TMF members revealed that no optimal solution was so far obtained. Hence a TMF task force developed possible formulations for standardized procedures in conformity with the German legal requirements.

Future of the TMF Originally, the TMF has been initiated by the BMBF in 1999 as meta measure to support infrastructural developments of the clinical research networks , which have been founded at the same time. Up to now, the TMF has developed a relevance and function far beyond its original aims. Additional networks, not funded by the BMBF, have joined the platform in acknowledgement of its broad offers and acceptance by various institutions in medical research and in the health care system. As a legal basis for the TMF, in 2003 a “registered association” (“eingetragener Verein”) was established to enable long term initiatives directed towards maintenance and sustainability of network based clinical research in Germany.

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www.kompetenznetze.de > Fields of Innovation > Medicine

Acute and Chronic Leukemias

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Improved cure rates for leukemia patients through closer cooperation

Alongside its own basic and applied research on diagnostics, bioinformatics and supportive care, the competence network also participates in projects led by all major German research groups specialized in leukemia therapy. The network involves about 1,500 physicians and scientists from 400 different centers (university hospitals, specialty practices and large community hospitals). Its goals are to intensify the search for new therapeutic strategies and pharmaceutical agents, accelerate the drug developement process, adopt new findings in genomics, telematics and biotechnology in the interests of medical progress, and share knowledge acquired through clinical trials.

Tracking down uncontrolled cell division Nobody knows quite why, but at some point the genetic information stored in a cell may change, causing uncontrolled division. The new cells fail to mature and are washed into the bloodstream in large numbers. These so-called blast cells have even lost the normal mechanism by which they ought to eventually ”selfdestruct”. The body’s perfectly regulated balance between newly generated and aging blood cells runs out of control. The consequence for 11,000 people in Germany each year is leukemia. Despite major advances in research, chances of cure are still limited for adult patients – the disease can only be cured in one out of three cases. The competence network for Acute and Chronic Leukemias was founded to provide better treatment for these patients and to improve their chances of cure. Treating the cause, not the symptoms

Chromosomes mapped by Interphase FISH (Fluorescence in Situ Hybridization)

NETWORK COORDINATOR Prof. Dr. R. Hehlmann Dr. Ute Berger Kompetenznetz Akute und chronische Leukämien III. Medizinische Universitätsklinik Wiesbadener Str. 7 – 11 D-68305 Mannheim Phone: +49 (0) 6 21 / 3 83 42 34 Fax: +49 (0) 6 21 / 3 83 42 39 E-Mail: [email protected] www.kompetenznetz-leukaemie.de

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There are different variants of leukemia, each consisting of various subtypes. They differ in their molecular and cytogenetic profiles, as well as in clinical symptoms, course and prognosis of the disease, calling for a corresponding variety of treatment strategies. The competence network has therefore chosen to define the gene and protein expression profiles of various leukemia subtypes on the basis of typical cytogenetic and molecular changes, and to identify the signaling pathways responsible for causing and stimulating leukemia. This will allow new drugs to be developed, capable of acting directly on individual genetic abnormalities. The new insights into genetic and molecular processes will form the basis for new methods of treating leukemia and may be equally useful in the treatment of other forms of cancer. Quality-assured diagnosis Precise, reliable diagnosis is an essential stage in choosing the right therapy. The competence network’s morphology group has installed a telemicroscopical system

to provide a consultation service for morphologic features of cells in blood and marrow. More than 20 institutions in Germany and Austria take part in weekly interactive telemicroscopy sessions, which allow the diagnostic skills of experts all over Germany to be rapidly brought together. Regular interlaboratory tests are staged via a diagnostics platform to assure standards of quality in morphology, cytogenetics, immunophenotyping and molecular genetics. From lab research to bedside care The competence network has succeeded in merging the data from various therapy studies, including rare forms of leukemia. Meta-analyses allow the results to be applied on a broader basis. By combining these results with basic research findings, it will be possible to develop effective drugs and treatment plans tailored to the needs of individual patients. Information for practicing physicians One of the network’s main objectives was to set up an efficient communication and information structure. At the Internet site www.kompetenznetz-leukaemie.de, physicians can quickly locate information on ongoing clinical trials, therapy guidelines and research results. Moving into Europe The EU’s Sixth Framework Programme aims to create an integrated ”European Research Area”. Last year, a group of more than 240 leading European experts in leukemia research from 23 different countries, led by Prof. Dr. R. Hehlmann, submitted a proposal to the European Commission for the creation of a ”Network of Excellence”. The researchers hope to create a lasting infrastructure for European research, and thereby further improve the care of leukemia patients.

www.kompetenznetze.de > Fields of Innovation > Medicine

Atrial Fibrillation

Year 2050: atrial fibrillation estimated to rise by 250% Atrial fibrillation is the most common sustained cardiac arrhythmia resulting in irregular heartbeat, shortness of breath and dizziness. Patients face an increased risk of thrombo-embolic complications such as stroke. The incidence of atrial fibrillation is age-dependent: in the overall population roughly 1%, in the elderly population up to 20%. By 2050, the number of patients with atrial fibrillation is estimated to rise by 250% due to demographic aging in Western nations. Prevention and effective therapy of atrial fibrillation are unmet needs. Atrial fibrillation is therefore an increasingly serious healthcare problem. Scientific projects • A decentralized patient register is being established and structured as a basis for epidemiological studies on the frequency and cause of asymptomatic, familial or latent atrial fibrillation. Gender-specific aspects and the question of whether alcohol may be a trigger factor are also being studied. Furthermore, consideration is being given to the occurrence of complications and to anticoagulation. • Seven multi-center randomized clinical studies are being conducted to evaluate different forms of treatment such as drug treatment, cardioversion, catheter-based or surgical ablation techniques, in addition to newly developed diagnostic tools such as imaging techniques, and the risk of neurological complications. • Experimental studies are based on the establishment of a networked tissue bank. These deal with pharmacologically and genetically induced changes in the electrical properties of cells and with the molecular-biological causes of atrial fibrillation and the associated structural changes.

Symptomatic palpitations, shortness of breath and stroke – atrial fibrillation has many different faces.

Infrastructural projects • The central office of the network is responsible for coordination, cooperation and public relations activities in the network, for informing doctors about training programs and organizing such programs, and for quality assurance. It also informs patients on events such as expert hearings. • An electronic data documentation system is being established for doctors to record the pseudo-anonymized data of their patients, e.g. present and past medical history, the type of atrial fibrillation, the underlying heart disease and co-morbidity, the chosen therapy. This electronic data documentation system is based on the Xtrail module, developed and operated by the Institute for Cardiovascular Research (www.ikkf.de). • A biometrical consulting service is being set up to support the planning, implementation and evaluation of the scientific studies.

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We aim to promote research, medical services and information towards improvement of the diagnosis and treatment of atrial fibrillation, the most common sustained arrhythmia of the heart.

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The Atrial Fibrillation Competence Network, set up in July 2003, is an interdisciplinary national research network funded by the Federal Ministry of Research and Education (BMBF). The network comprises patients, physicians and scientists. Patients are recruited from all levels of patient care in order to build a nationwide, representative registry. Physicians and scientists conduct multi-center, prospective trials and combine their methodological approaches to improve the understanding of atrial fibrillation and develop optimized diagnostic and therapeutic options. The network coordinates about 20 scientific projects dealing with the epidemiological, clinical and experimental aspects of atrial fibrillation. These are subject to internal and external quality control and will lead to guideline-based recommendations for improving treatment. A further 3 groups are working on subprojects to establish an efficient science infrastructure.

NETWORK COORDINATOR Univ.-Prof. Dr. G. Breithardt Chairman, Atrial Fibrillation Competence Network Central Office Universitätsklinikum Münster Waldeyer Strasse 30 D-48149 Münster Phone: +49 (0) 2 51 / 83 - 4 53 40 Fax: +49 (0) 2 51 / 83 - 4 53 43 E-Mail: [email protected] www.kompetenznetz-vorhofflimmern.de www.af-net.de 9

www.kompetenznetze.de > Fields of Innovation > Medicine

Brain-Net

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The German Reference Center for Diseases of the Central Nervous System

Brain-Net is the German Reference Center for Diseases of the Central Nervous System; it has been funded by the German Federal Ministry of Education and Research (BMBF) since October 1999. Its main task is to establish a brain and tissue bank, in pursuit of the following objectives: • Standardized sampling of brain tissue of patients and control subjects who have given their approval for such storage • Standardized neuropathological diagnosis • Verification of clinical diagnosis and validation of clinical methods • Supply of tissue samples to promising neuroscience research projects

The need for brain and tissue banking Brain banks have a long tradition in many other countries, such as in Great Britain, the Netherlands and the United States. Since there are no suitable animal models for most neurological and psychiatric disorders, scientists investigating these disorders depend on the availability of well-characterized human tissue. The Brain-Net initiative Brain-Net was set up on the initiative of various research networks in the neurological and psychiatric field (Parkinson’s, depression, schizophrenia, stroke), with the aim of establishing a brain and tissue bank. It collects the brains of deceased patients suffering from diseases of the central nervous system and the brains of control subjects following donor agreement. The 15 participating university institutes are coordinated by the BrainNet Secretariat at the Institute for Neuropathology of the Ludwig-Maximilian University in Munich. Important service for the brain research community

NETWORK COORDINATOR Prof. Dr. H. A. Kretzschmar Secretariat: Institute for Neuropathology, Ludwig-Maximilians-Universität München Feodor-Lynen-Str. 23, D-81377 München Phone: +49 (0) 89 / 2 18 07 80 00 Fax: +49 (0) 89 / 2 18 07 80 37 E-Mail: Hans.Kretzschmar@ med.uni-muenchen.de www.brain-net.net Contact for the press: Dr. M. Neumann Phone: +49 (0) 89 / 2 18 07 80 65 E-Mail: Manuela.Neumann@ med.uni-muenchen.de

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Tissue samples are supplied on request to promising neuroscience research projects. Brain-Net has been able to fulfil numerous requests for well-characterized tissue specimens, and thus helped many national and international research groups to pursue their work of improving our understanding of the underlying causes of certain diseases and to develop new therapeutic approaches. In the past, the results of this type of neuropathological and biochemical research have led to the development of drugs for treating Alzheimer's disease (acetylcholinesterase inhibitor) and Parkinson's disease (L-DOPA).

The members of Brain-Net have special expertise in the following areas: Parkinson's disease and other forms of Parkinsonism, Alzheimer's disease and other forms of dementia, CreutzfeldtJakob disease, amyotrophic lateral sclerosis, brain trauma, vascular disorders, multiple sclerosis, epilepsy, brain tumor, addiction, schizophrenia, depression, sudden infant death, pediatric neuropathology. Raising public awareness Currently, a brain autopsy is the only way to confirm the clinical diagnosis of most neurodegenerative disorders, such as Alzheimer’s and Parkinson’s disease. If more brains were available for research, it might be possible to improve the present misdiagnosis rate of 20%. Brain-Net hopes to ameliorate the situation by informing interested patients and their relatives and medical staff about relevant clinical symptoms and the usefulness and necessity of post-mortem examinations and donations of tissue to research.

www.kompetenznetze.de > Fields of Innovation > Medicine

CAPNETZ – Community Acquired Pneumonia

A Web-based all-in-one system for multicenter clinical studies Multicenter clinical studies place high demands on everyone involved, and on the software being used. This software must support communication – and thus cooperation between people working at different sites. It must be capable of managing shared files and, not least, allow the study to be implemented in accordance with internationally applicable standards. Conventionally, these requirements are met through the use of a whole range of software products, each of which fulfills only some of the requirements. Experience shows that the necessary training demands a great deal of work, motivation, and time. Resources for the desired core activity – namely, conducting the study – are therefore lost. CAPNETZ has developed a Web-based all-in-one system that establishes a corporate identity, includes the Internet presence of the competence network, meets the stated requirements, and, furthermore, provides a great deal of support to everyone involved. Corporate identity & what you see is what you need All the system's content and functions are in line with the specified corporate design, thus clearly promoting the corporate identity. The ”what-you-see-is-what-you-need” function makes it very easy to use the system: for example, dynamic case report forms in which sections open and close depending on the last input. Communication tools & document management The system supports the necessary networking of people working at many different sites through integrated communication tools. Synchronous and

asynchronous connections are established in the form of video conferences, secure email, etc. There is a shared address book and time planner and a common file repository that permits collaborative working on documents. Study management via the Internet & good clinical practice (GCP) In conformance with GCP, the system supports the design, conduct, recording, and reporting of multicenter clinical trials. It includes multilevel plausibility checks during data input, highlighting of exceptional or missing data, commenting and logging of all changes, and monitoring support. Values are automatically calculated and converted, the case report sheets are produced visually, and standard operating procedures are supported. The entered data is recorded, transmitted, and stored in a secure environment, in conformity with data protection guidelines.

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CAPNETZ is a nationwide German network of medical practices, clinics, and research institutes with the common aim of developing evidence-based strategies for diagnosing and treating the widespread disease ”community acquired pneumonia (CAP)”.

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Web-based conduct of a multicenter study and synergic networking of research CAPNETZ is carrying out a multi-center clinical-epidemiological study on CAP and producing a central material base and database. This involves collaboration by the leading research institutes in the field with physicians in general practice and hospitals, microbiologists, virologists, epidemiologists, and computer scientists. To conduct the study, a system was developed which allows any medical-scientific study to be conducted in compliance with international standards via the Internet. The system covers all stages of design, conduct, recording and reporting.

All-in-one The all-in-one system implemented in CAPNETZ can be used and administered entirely via the Web. It meets the requirements for carrying out multicenter clinical trials in a single program environment and can be used for any Internetbased medical-scientific study.

NETWORK COORDINATOR Dr. Klaus Richter CAPNETZ Geschäftsführer Albert-Einstein-Allee 47 D-89069 Ulm Phone: +49 (0) 7 31 / 5 00 25 - 303 Fax: +49 (0) 7 31 / 5 00 25 - 339 E-Mail: [email protected] www.capnetz.de

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Cogenital Heart Defects

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We are creating an efficient research structure for congenital heart defects that benefits patients, industry, and government, and which gives longterm strength to Germany's reputation as a place of research.

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The Competence Network for Congenital Heart Defects is a national research project, funded by the Federal Ministry of Education and Research (BMBF) since 2003. It combines basic interdisciplinary medical research into congenital heart defects with clinical research and medical care. The network focuses on • setting up an efficient research structure, • ensuring the quality of research and care, and • informing doctors, patients, and the public about congenital heart defects. Doctors, scientists, parent associations, and self-help groups work together in the network. The aim is to ensure an effective transfer of knowledge and to guarantee better care for patients with congenital heart defects.

Magnetic resonance tomography of the pulmonary artery of a child

Networked research: added value for patients and scientists Congenital heart defects are the most frequent congenital illness. Each year in Germany, about 6,000 children are born with such defects. Owing to the progress made in pediatric cardiology, heart surgery, and anesthesia, over 90% of patients now reach adulthood. The majority – currently about 300,000 children, young people, and adults – remain chronically ill for life. Research for people The number of patients in individual research centers is small. A networked research structure on congenital heart defects is therefore the basis for advances in the treatment of this syndrome. Hitherto, there have been few generally applicable details on the epidemiology and course of the illness. Multi-centric studies are still the exception. The core aim of the network is therefore to set up a networked research structure and a patient database. The ”National Register for Congenital Heart Defects“ is to be the central epidemiological tool for German pediatric cardiology. For the first time, the directory will make it possible to combine data from different studies and to obtain figures for this illness.

NETWORK COORDINATOR

Ensuring the quality of research

Netzwerkzentrale Kompetenznetz Angeborene Herzfehler Augustenburger Platz 1 D-13353 Berlin

The networked research structure makes it possible to distribute studies on the subject throughout Germany, thereby efficiently generating high-quality research results. Use is made of the latest techno-

Phone: +49 (0) 30 / 4 50 - 57 67 72 Fax: +49 (0) 30 / 4 50 - 57 69 72 E-Mail: [email protected] www.kompetenznetz-ahf.de 12

logies, such as magnetic resonance tomography (MRT). With MRT, widely different parameters on the working of the right chamber of the heart can be recorded. It is thus possible to obtain an anatomical representation of the heart, and functional data about the working of the chamber, shunt volumes, and valve stenoses or insufficiencies. This could previously only be studied invasively with a heart catheter. For patients, these noninvasive examinations are free of pain and involve no radiation. The MRT data obtained is sent by Telemedicine to the central database, where it is networked and analyzed. The database is available to all study groups on the network. The high-quality research results rapidly generate guidelines on the treatment of this complex syndrome. Widespread investigations For the first time, the networked analysis of data makes it possible to carry out widespread investigations into the link between treatment and the health of patients with the illness. The competence network thus provides added value for scientists and patients. In future, international groups of researchers will also be able to use this efficient structure.

www.kompetenznetze.de > Fields of Innovation > Medicine

Dementia

First nationwide network of dementia clinics Approximately one million German citizens suffer from dementia, of which 200,000 new cases are diagnosed each year. A unique network of dementia clinics has been set up, while the expansion of structures in healthcare provision is being tackled. This is the first time that the creation of such structures has been supported through state funding (BMBF). As a result, interdisciplinary communication has improved, and expertise and knowledge is being shared which will undoubtedly lead to a significant improvement in medical care for dementia patients. A multi-centered network using standardized diagnostic and therapy procedures As a result of the formation of the network, standard procedures in neuropsychological diagnosis of cognitive disorders have been drawn up. This means that dementia patients can be diagnosed according to standardized criteria. Standard procedures in neurochemical analysis have also been established, which ensure that all samples are uniformly prepared prior to their analysis for specific disease markers (e.g. amyloid beta petpides and phosphorylised tau protein). Furthermore, the samples from the centers are analyzed in three designated laboratories, where specially trained staff ensure observance of defined common guidelines. More representative, larger sets of samples from different centers can now be analyzed collectively, rather than being studied individually by a few highly specialized centers. A uniform procedure for magnetic resonance imaging has also been defined and is successfully inplemented. This enables data from different tomographic images to be integrated in the same study. In order to ensure that all centers

Processing of spinal-fluid and blood samples for early and differential diagnosis using neurochemical analysis

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Dementia: Better recognition – better treatment – better help for sufferers by a nationwide research and medical care network

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The Dementia Competence Network is a nationwide network of 14 leading, university-centered, dementia research groups. Hospitals, doctors, the German Alzheimer’s Association and commercial partners are involved in this BMBF-supported project. The network’s three main areas of work are: early recognition and diagnosis, epidemiology and genetics, and therapy. The aims of this work are to improve clinical diagnosis and enable a more accurate differential diagnosis, to develop more effective therapies, and to create a nationwide healthcare structure to optimize patient treatment. The network was formed in June 2002 and has been a registered association since June 2003.

comply with these newly introduced procedures, phantom examinations are also carried out. A multi-centered, clinical infrastructure has been established for the purpose of pharmacological doubleblind tests. This infrastructure provides a reliable means of monitoring data collection and assuring the quality of, for example, diagnostic screenings, randomization and preparation of medicines in blind form, and shipment of medication by manufacturers and distributors. Through the wide implementation of standard procedures and the immediate accessibility of a structured system for collaborative working, the competence network offers attractive resources for other study projects.

NETWORK COORDINATOR Dr. Petra Hubrich Coordinator of the Dementia Competence Network Central Institute for Mental Health J5 D-68159 Mannheim Phone: +49 (0) 6 21 / 1 70 39 57 Fax: +49 (0) 6 21 / 1 70 37 60 E-Mail: [email protected] www.kompetenznetz-demenzen.de

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www.kompetenznetze.de > Fields of Innovation > Medicine

Depression and Suicidality

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Depression can affect everybody Around four million people suffer from depression in Germany. The Depression and Suicide Competence Network seeks to improve the lives of these patients by encouraging a more collaborative approach to their care and treatment.

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Optimization of research and healthcare provision Through the nationwide Depression and Suicide Competence Network, doctors, therapists, research groups and healthcare organizations have been brought together with the common objective of tackling the increasing number of cases where a depressive illness overlaps with suicidal tendencies. The project aims to involve scientists, professional carers, the general public and patients on an equal basis. In addition to specific research projects, the aim is to improve the flow of information between all professional organizations involved in providing care for sufferers. The Depression and Suicide Competence Network therefore includes not only doctors, specialists, research institutions, university and psychotherapy clinics, hospitals and health insurance companies, but also industrial partners.

The successful ”Nuremberg Alliance against Depression” will be extended not only to many German regions but also on a European scale When the program ”Alliance Against Depression” was launched in 2001, it was initially restricted to the Nuremberg region. The published results and the new methods developed have been such a resounding success that the program has rapidly spread to other German and some European regions. The information material has even been translated into Icelandic. The Alliance’s aim was not only to improve the care provided to people with depression but also – by evaluating the available data – to prevent the downward spiral that in the worst case can lead to suicide. These efforts have not been in vain: After one year of intervention, the rate of suicide attempts dropped by a significant 20%. A four-level action program The Nuremberg initiative is aimed at four different target groups. Interactive training programs have been developed for medical practitioners, and special educational seminars have been organized for potential mediators such as teachers, priests and geriatric caregivers. An awareness campaign has been produced for the general public, in the form of open days, lectures, flyers and brochures, and even cinema advertising. And patients suffering from depressive illnesses have been issued with special emergency cards and a hotline number for use in times of crisis. The European dimension

NETWORK COORDINATOR Prof. Dr. Ulrich Hegerl Psychiatric Hospital of the Ludwig-Maximilians-University Munich German Research Network ”Depression, Suicidality” Nußbaumstraße 7 D-80336 München Phone: +49 (0) 89 / 51 60 55 53 Fax: +49 (0) 89 / 51 60 55 57 E-Mail: [email protected] 14

The significant achievements of the ”Alliance Against Depression” in Germany have resulted in an expansion of the program into Europe. Funds have been awarded by the European Commission to implement the program on a panEuropean scale from mid-2004 onward. Seventeen countries have shown an interest in the ”European Alliance Against Depression” (EEAD).

The Icelandic campaign poster informs that ”depression can affect everybody”.

Further expansion on the home front With continued support from the BMBF and the patronage of Federal Minister Renate Schmidt and Minister of State Günter Beckstein, the ”Alliance Against Depression” program is being expanded. The aim is not only to extend the concept to other regions of Germany, thereby broadening the exchange of information, but to continually develop and evaluate the program. Eight different regions in Germany, from Lübeck to Kempten, have so far registered as partners as well as Iceland and two European regions in Switzerland and Italy.

www.kompetenznetze.de > Fields of Innovation > Medicine

Heart Failure

Targeted areas of activity The Heart Failure Competence Network seeks to act as a value-creation resource by forging numerous and effective links between patients, clinicians and research scientists. Value is created through 3 key areas of activity – specialist information, communication, and working tools and methods – using a targeted approach to address each user group according to its specific needs. Specialist information The presentation of information is crucial. For patients it should be clear and understandable, for clinicians more concise and practice-oriented, and for research scientists extremely precise and detailed. Information is disseminated via the Internet, through lectures and symposia, and in printed brochures and other publications. Communication An improvement in the flow of information between clinicians and research scientists is being actively targeted through the Heart Failure Competence Network. The respective specialist fields of different working groups and reference centers are integrated in joint study projects, to produce collective results which could not be achieved by an individual group alone. A Web portal facilitates collaboration and communication between scientists, clinicians and patient groups through address lists, newsletters and forums.

ing data quality. It also develops practical guidelines for the medical profession, incorporating the latest research findings.

Milestones for 2003/2004 Standardized cardiology records Leading experts in the area of heart failure have recently standardized procedures for data collection in clinical studies. This means that studies can be qualitatively and quantitatively compared for the first time, which may lead to the discovery of important, new findings. Additionally, the setting of these standards provides a framework for other studies, which will inevitably result in greater efficiency. In this respect, the Heart Failure Competence Network has already achieved one of its main aims: to provide methods and tools which assist scientists in their work.

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The Heart Failure Competence Network provides specialist information, a communications platform, and practical instruments for research in heart failure.

Heart failure is a life-threatening condition with a mortality rate comparable to many forms of cancer. It affects more than 1 million people in Germany today, and is expected to become the most common cardiovascular disease of the 21st century, in view of the steadily rising number of cases. The Heart Failure Competence Network was founded in June 2003 and represents an interdisciplinary collaboration between scientists and healthcare providers. The aims of the Heart Failure Competence Network are to encourage more effective scientific research, better patient care, and greater public awareness. Formation of network has enabled the creation of a national forum and action plan, which will improve not only the quality of life but also the life expectancy of sufferers.

Creation of a biomaterials bank The Heart Failure Competence Network has been given official approval to set up a biomaterials bank. This central facility, which fulfils strict data protection requirements, will supply high-quality and rare tissue samples prepared according to standard procedures, for use in experimental studies. Informative seminars for patients

Working tools and methods The third key area of activity is to develop tools and methods to improve and simplify scientific research and the treatment of heart failure. To coordinate this work, a center for study management and biometry has been set up in Leipzig. The center’s main task is to develop standard data formats and uniform database structures, including data protection, as a means of simplifying the planning and execution of follow-up studies, and assur-

Prevention is another important aspect of heart failure which the competence network seeks to promote by providing patients with clearly presented information on the symptoms of the disease. As part of a pilot project, regular seminars are held in Berlin at the Charité Campus, highlighting selected topics related to heart failure. It is hoped that this service can be offered on a national scale in the near future.

NETWORK COORDINATOR The Heart Failure Competence Network Augustenburger Platz 1 Mittelallee 11, 2. OG D-13353 Berlin Phone: +49 (0) 30 / 450 576 812 Fax: +49 (0) 30 / 450 576 962 E-Mail: [email protected] www.knhi.de

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www.kompetenznetze.de > Fields of Innovation > Medicine

HEP-NET – Hepatitis

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Network of research, at all levels of care, for the benefit of hepatitis patients.

Alongside the network of university and other research facilities intended to improve research into virus hepatitis in Germany, Hep-Net has the task of providing the latest research results without delay to patients being treated outside the specialized university institutions. The aim is to guarantee high-quality management of viral hepatitis at all levels of care. A network of clinical researchers and pure scientists, doctors in hospitals and in their own practices, and patient self-help organizations are actively incorporated into research projects. Important focal points of research include the development of a vaccine against hepatitis C, the conduct of clinical studies, and the collection of epidemiological data on the incidence and prevalence of hepatitis B and C in Germany.

NETWORK COORDINATOR Prof. M. P. Manns, M. D. (Chairman of the network) Kompetenznetz Hepatitis c/o Medizinische Hochschule Hannover Carl-Neuberg-Str. 1 D-30625 Hannover Phone: +49 (0) 5 11 / 5 32 68 19 Fax: +49 (0) 5 11 / 5 32 68 20 E-Mail: [email protected] www.kompetenznetz-hepatitis.de

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”All of a sudden, everything‘s different” The diagnosis of chronic hepatitis C or B is often a shock for those concerned. Numerous questions arise among the chronically infected in Germany – estimated to be one million. What is hepatitis? How is it transmitted, and am I a risk to my family? What are its consequences, and how can I be treated? Many of these questions have not been satisfactorily answered – even for researchers. Improving the general standard of diagnosis and treatment requires the cooperation of epidemiologists, clinicians, and pure scientists – which is the starting point of Hep-Net. At the same time, intensive publicity – particularly regarding prevention – is designed to reduce the expected peak of hepatitis patients in Germany in 2020. Innovation highlight regarding acute hepatitis C After only two years, Hep-Net has already had some success. For instance, close cooperation between universities and registered doctors has led to an international standard for the treatment of acute hepatitis C. With twenty-four weeks of treatment using Interferon alfa, the illness can be prevented from becoming chronic in more than ninety percent of cases. In addition, virus kinetic analyses of large numbers of patients have made it possible to develop a ”response calculator”. This is able to predict how individual patients with chronic hepatitis C are likely to respond to treatment, and it motivates them to carry on with the Interferon-based treatment, with all its side effects.

Furthermore, an approach has been adopted in Germany that is unique in the world – namely, the establishment of ”model regions”. In these, the active cooperation of doctors and patients ensures that data about the illness, and tests on serums and tissue, are made available to the Hep-Net research projects, including, for example, regarding the pathogenesis of the disease. A comprehensive analysis is also carried out of the care provided in these geographical model regions, and wide-ranging educational strategies with publicity value are put into effect. Profile of the competence network Hep-Net is of one of the largest competence networks in medicine within Germany. The close-on fifty Hep-Net research projects – which are primarily the responsibility of various university institutes and about 120 researchers – receive an annual grant from the BMBF of roughly 2.5 million euros. Since HepNet was launched in February 2002, about 600 additional associate members have been recruited. Particularly within the ”model regions”, they are making an active contribution to research into virus hepatitis.

www.kompetenznetze.de > Fields of Innovation > Medicine

HIV/AIDS

HIV has many faces – research as well The bringing together of scientific expertise through the HIV/AIDS competence network has resulted in tangible success. One example is a project studying HIVpatients who are co-infected with the hepatitis C virus (HCV). The prognosis for such patients is significantly worse than that of patients with the HI-virus alone. They often die from complications associated with liver damage, which has been initiated by the hepatitis virus. Scientists in Bonn, however, have made it easier for co-infected patients to decide on an appropriate therapy. The scientists have recommended that the co-infected patients, either at a critical stage of HIVinfection or when both viruses are circulating in the blood, receive a combination therapy. This combination therapy includes the latest treatment against HIV (HAART) and ensures that the immune system recovers while keeping the hepatitis virus in check. As a result, the life expectancy of the patient rises, which is a significant achievement outweighing the side-effects of the combined medication. The importance of the gastrointestinal tract The HI-virus is not only present in the bloodstream of HIV-patients, but also in the intestinal mucosa. It is here that large numbers of immune cells die and, as a consequence, many patients become ill through stomach and/or intestinal infection resulting in severe diarrhea. A group of scientists led by Professor Martin Zeitz has found that the intestine is most probably the main production site in the body for the human immunodeficiency virus. The virus attacks the intestinal mucosa at an early stage and multiplies particularly vigorously in this region. Indeed, the number of copies of HI-virus in the intestine has been found to be up to 1000-fold higher than in the blood. It is however in the intestinal mucosa, according to Zeitz and colleagues, where the HIV-medication works most rapidly and effectively. Using the latest combina-

tion therapy, the immune cell number in the intestinal region has been found to increase 10 times as quickly as in the blood. Indeed, within three of months of beginning therapy, the immune cell level in this region may even be comparable with healthy individuals. In this way, the intestine can successfully combat the virus with the result that symptoms, such as diarrhea, cease. Tracking viral resistance HI-viruses have the ability to transform. This characteristic makes it difficult to find a successful, long-term drug treatment as the virus can quickly change and become resistant to such treatment. According to the latest results from the HIV Seroconversion Study, which is being carried out by the Robert Koch Institute and supported by the HIV/AIDS competence network, around 20% of newly infected individuals in Germany are carrying resistant HI-viruses. The project, however, is ensuring speedy identification of resistant forms of the virus and monitoring the change in efficiency of treatment on such forms.

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The HI-Virus adapts quickly. Research in the HIV/AIDS competence network too.

Leading clinical and research science groups in Germany have come together within the framework of the HIV/AIDS competence network. Through this national research alliance, HIV-patients have been recruited to take part in clinical studies nationwide for the first time. It is hoped that the results of these studies will improve the international standing of HIV-research in Germany. The core project within the HIV/AIDS competence network, which was started in June 2002, is the formation of a central database drawing information from a representative, national, patient cohort. As a result, significant findings and anomalies in the areas of epidemiology, medicine, psychosociology and healthcare should be identified at an earlier stage. Beautiful, but dangerous: the Human Immunodeficiency Virus (HIV)

Finally, the long-term course of the illness is also being observed. HIV research gives inspiration to other areas of research The findings obtained through HIVresearch are not only benefiting those infected with HIV and AIDS-patients, but other areas of medical research as well. Significant advances, linked to HIVresearch, have been made in immunology (particularly immunization), oncology, infectious diseases and pharmacology. Prime examples of this are the drugs Zanamivir (used against influenza) and Lamivudine (used in hepatitis B therapy).

NETWORK COORDINATOR Prof. Dr. med. Norbert Brockmeyer (Chairman of the HIV/AIDS competence network) Department of Dermatology and Allergology at the Ruhr University Bochum Gudrunstrasse 56, D-44791 Bochum Phone: +49 (0) 2 34 / 5 09 - 34 71, -34 74 Fax: +49 (0) 2 34 / 5 09 - 34 72, -3475 E-Mail: [email protected] www.kompetenznetz-hiv.de

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www.kompetenznetze.de > Fields of Innovation > Medicine

Inflammatory Bowel Diseases

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We aim to promote networked research, medical services and information towards improvement of the diagnosis and treatment of inflammatory bowel diseases. Our goal is to resolve this medical problem within the next decades.

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New technical and pharmaceutical breakthroughs have dramatically improved the prognosis of patients with Crohn’s disease or ulcerative colitis. Research groups at the university clinics of Kiel, Berlin, Regensburg and Tübingen, together with over 100 hospitals and research institutes, and the national patient organization, are working to integrate new methods in healthcare practice. With access to numerous specimen banks for serum, tissue samples and genetic material, and significant groups of patients, the competence network’s project groups have been able to formulate and answer questions related to molecular epidemiology, disease models, clinical studies, and the social and economic consequences of disease.

Take a look inside – Charting Crohn’s disease using ”capsule endoscopy” A worldwide, multi-center clinical trial started recently, focussing on the assessment and clinical significance of Crohn’s disease lesions detected by capsule endoscopy. This study will address the difficult task of predicting the course of the complicated, relapsing disorder. It is organized and led by clinicians from the German Network on Inflammatory Bowel Diseases. Crohn’s disease is a chronic relapsing disorder in which cycles of remission alternate with clinical activity. Lesions can occur in any region of the gastrointestinal tract. Until recently the only way for physicians to ”take a look inside” the intestine was through the use of upper or lower endoscopy. The ingestible endoscopic capsule is the first method yielding pictures throughout the whole small bowel.

hospitals, involved in the Network on Inflammatory Bowel Diseases, are among the pioneers using capsule endoscopy in Germany. Maintenance of remission in Crohn’s disease can require the use of drugs that have considerable side effects. Presently, the intensity of therapy is increased if disease activity returns. If it were possible to predict relapses, therapy could be intensified as a preventative measure. Until now only experimental immunological parameters – impracticable for wide-spread use – can be used for the prediction of relapses. The objective of the new study is to screen patients with Crohn’s disease in medically induced remission for the presence of small bowel lesions. It is hypothesized that these may identify patients

The labyrinth represents the complexity of the gastrointestinal tract – and of the scientific challenge

An ingestible camera measuring 11 x 26 mm and weighing less than 4 grams

Pioneers in capsule endoscopy

NETWORK COORDINATOR Speaker: Prof. Dr. U.R. Fölsch Scientific secretary: Prof. Dr. S. Schreiber Clinic for General Internal Medicine of the University Hospital Schleswig-Holstein Campus Kiel Schittenhelmstrasse 12 D-24105 Kiel E-Mail: [email protected] 18

The patient prepares for capsule endoscopy with a ten-hour fast. The single-use capsule has to be activated, is then swallowed and transported by peristalsis. Twice every second LEDs flash and a wide-angle magnified picture is taken. Each frame is immediately transmitted to a small data recorder connected with a set of sensors on a belt around the waist. This out-patient procedure takes about 8 hours. Data from the recorder are transferred to a computer workstation for analysis by a physician. The university

with unstable remission who are threatened by a return of disease activity in the near future. Patients in the study will be observed over 24-month period. A wish come true Patients would certainly welcome it if non-invasive procedures like capsule endoscopy could eventually replace unpleasant and often painful investigations. This study may be a first step in this direction. The industrial partner in this study is Given Imaging Ltd, Yoqneam, Israel.

www.kompetenznetze.de > Fields of Innovation > Medicine

Malignant Lymphomas

All lymphoma patients are entitled to the best possible treatment Helping to choose the right therapy

The Web as information resource

In view of the vast number of published research papers, systematic reviews significantly aid the decision-making process for doctors and patients when determining the best possible treatment. One research group supported by the network, the Cochrane Hematological Malignancies Group (CHMG), has published 4 such reviews to date, with a further 24 in preparation. As part of the CHMG’s ”consumer network”, patients also contribute to the reviewing process.

The Malignant Lymphomas competence network website www.lymphome.de was relaunched in September 2003. It provides patients and doctors with a reliable source of the latest scientific information on malignant lymphomas, including reports on current research projects. Contributions from other European lymphoma study groups will also be available soon. In order to extend its reach, the site’s English-language content is currently being augmented.

Benchmark data from private practices Over 80 practicing hemato-oncologists have joined forces in the competence network. In order to evaluate and compare malignant lymphoma patient data and treatment, while preserving the patients’ anonymity, a special software program (MLData) has been developed which extracts relevant information from practice records and enters it in an electronic spreadsheet. This software was used to evaluate data from more than 2,000 patients in 8 practices in 2002. The analysis of patient data from 12 private practices is now in progress for the year 2003.

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The Malignant Lymphomas competence network brings together the most recent scientific findings and knowledge in this field and improves the cross-disciplinary flow of information, with the aim of ensuring the best possible treatment, care and information for all lymphoma patients.

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Through the Malignant Lymphoma competence network, leading lymphoma research groups and healthcare organizations have combined their expertise in order to improve communication between scientists, physicians and patients, and ensure that recent scientific developments are implemented as quickly as possible in primary healthcare practice. Specialists in hemato-oncology, pathology and radiology, together with scientists, statisticians and computer scientists work towards this goal alongside the research groups. Patients and self-help groups are also involved, thereby ensuring that their views and requirements are considered when determining the objectives of the research projects.

Lymphoma entities in eight practices

www.lymphome.de offers patients and doctors accurate and up-to-date information about malignant lymphomas.

NETWORK COORDINATOR Prof. Dr. Volker Diehl (network spokesman) Central Office of the Competence Network Malignant Lymphomas University Hospital Cologne Joseph-Stelzmann-Str. 9 D-50924 Cologne Phone: +49 (0) 2 21 / 4 78 74 00 Fax: +49 (0) 2 21 / 4 78 74 06 E-Mail: [email protected] www.lymphome.de

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www.kompetenznetze.de > Fields of Innovation > Medicine

Parkinson's Disease

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The Parkinson’s Competence Network seeks to create links between research, diagnosis and therapy in an attempt to optimize care for patients, and to allow research into Parkinson’s disease in Germany to play a more significant role at an international level.

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The patient is of central importance The main aims of the Parkinson’s Competence Network are to make Parkinson’s research more goal-directed and effective, and to speed up the transfer of basic and clinical research results into healthcare practice. Patients stand to benefit considerably from the improved communication between researchers, doctors, clinics, insurance and medical companies, and self-help groups. Three databases have been created; a central patient register, a gene bank and (in cooperation with Brain-Net) a brain bank. Other projects focus on early and differential diagnosis, multicenter pharmacological and deep brain stimulation studies and economic analysis of the cost of care.

When movement is restricted … Parkinson’s disease was first described (as ”shaking palsy”) in 1817, by the English physician whose name it now bears. The chronic, progressive illness is largely but not exclusively a disease of old age, afflicting 1 in a hundred persons over 60. The chief symptoms are slowed movements, occasional tremors, muscular stiffness, and trouble with balance and coordination. … communication becomes all the more important Collaboration and communication are the bywords of the Parkinson’s Competence Network. The first step in its development was therefore to set up a secure Web-based data entry and communication system, for the analysis of data from different projects. Access to patient data is restricted to authorized physicians, and all possible security mechanisms are implemented to ensure data privacy (including the pseudonymization of patient data). Multi-center studies

Movements have no real momentum, as if obstructed by an inner wall.

NETWORK COORDINATOR Professor Wolfgang H. Oertel (Spokesman for the Parkinson Competence Network) Dr. Karla Eggert (Coordinator for the Parkinson Competence Network) Scheppe Gewissegasse 8 D-35039 Marburg Phone: +49 (0) 64 21 / 2 86 52 72 Fax: +49 (0) 64 21 / 2 86 53 08 E-Mail: [email protected] www.kompetenznetz-parkinson.de 20

guidelines were published in book form by the Thieme-Verlag in 2003, and are also available on the publisher’s website, or through the authors’ (KNP and DGN) websites.

The participating members of the Parkinson’s Competence Network, with their vast experience in this field, formed the German Parkinson’s Study Group in 2003. This group will carry out nationaland international-scale studies on behalf of the pharmaceutical industry as well as investigator-initiated studies. The national database (3800 entries as of end 2003) makes it possible to quickly recruit patients with specific symptoms or disorders for participation in clinical studies. Therapy guidelines A set of guidelines for the treatment of Parkinson’s disease have been drawn up by the Parkinson’s Competence Network (KNP) and the German Neurological Society (DGN), in consultation with the German Parkinson‘s Society (DPG) and numerous other respected organizations representing Germany’s medical and neurological practitioners, as well as a national patients’ self-help group. These

With early diagnosis and the latest treatment, the wall can be broken down.

Economic analysis and benchmarking Several studies are currently under way to evaluate the medical and non-medical costs of treating patients with Parkinson’s disease. Various factors are taken into consideration, including the stage of the disease and the extent of motor complications. Certain results of these studies have already been published. Meanwhile, the Parkinson’s Competence Network continues to work on disease management concepts in collaboration with the German neurologists’ professional association (BVDN), to encourage the use of standard recording practices for patient data.

www.kompetenznetze.de > Fields of Innovation > Medicine

Pediatric Oncology and Hematology

New method can detect one leukemia cell among a million normal cells To discover that your child has cancer is one of the cruelest blows of fate that could befall a family. So it is all the more encouraging to know that medical progress has significantly improved survival rates over the last twenty years. A project launched by the Competence Network Pediatric Oncology and Hematology (KPOH) and led by Professor Jochen Harbott is devoted to Minimal Residual Disease (MRD) in leukemia and lymphomas. By employing innovative methods of detecting cancer cells that otherwise seem to have ”disappeared”, it has led to the more accurate identification of malignant cells in patients suffering from leukemia or non-Hodgkin’s lymphoma, which together account for half of all cases of childhood cancer. With the combined help of molecular genetics and immunology, it is now possible to pick out one leukemia cell among a mil-

lion normal cells. The technique is being used to define personalized treatment plans with a greater chance of success. Such methods will soon enable leukemiaspecific indicators to be defined for each patient, allowing therapeutic progress to be monitored more closely. Unique tumor tissue bank In 2001, the network set up a tumor tissue bank containing a unique collection of high-quality samples for research, taken from patients with rare tumors. They include representative samples of the majority of malignant tumors found in children. It is hoped that this will lead to new biological, immunological and molecular-genetic findings that will help to improve diagnosis and treatment.

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A more coordinated approach to improving diagnosis and treatment

The Competence Network Pediatric Oncology and Hematology (KPOH) is an alliance of scientists, medical practitioners, hospitals, special cancer units, and patients, with a common interest in improving pediatric oncology. It was founded in 1999 as a means of coordinating the activities of all those who have to deal with these relatively rare but life-threatening diseases. The network aims to develop a more coordinated approach to improving the diagnosis and treatment of cancer in children, including appropriate quality standards. Today, over 90% of young cancer patients in Germany receive medical care on the basis of standardized treatment plans. The network currently hosts ten collaborative projects spread over 3 major areas: infrastructure, basic research and clinical research. An extensive library of useful information for patients, their families, healthcare professionals, and researchers can be consulted on our Web portal at http://www.kinderkrebsinfo.de.

NETWORK COORDINATOR Prof. Dr. med. Dr. h. c. Günter Henze Koordinationszentrale Kompetenznetz Pädiatrische Onkologie und Hämatologie Charité - Universitätsmedizin Berlin Campus Virchow-Klinikum Augustenburger Platz 1 D-13353 Berlin Phone: +49 (0) 30 / 450-566834 Fax: +49 (0) 30 / 450-566906 E-Mail: [email protected] www.kinderkrebsinfo.de 21

www.kompetenznetze.de > Fields of Innovation > Medicine

Rheumatology

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People with systemic inflammatory rheumatic diseases now have more hope than ever. As a result of more accurate diagnosis and new, more effective therapies, it is now possible to slow down the destructive processes which occur in the joints and internal organs of sufferers.

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Clinical scientists in rheumatology clinics at 6 universities (Berlin, Düsseldorf, Erlangen, Freiburg, Hanover and Lübeck/Bad Bramstedt), research scientists from the German Rheumatism Research Center in Berlin, doctors from 27 of the regional Arthritis Centers and practicing rheumatologists are successfully collaborating through the Rheumatology Competence Network. Their aim is to discover the causes of rheumatic diseases, to facilitate and improve diagnosis and to develop more effective therapies. The main areas of work are rheumatoid arthritis, spondyloarthropathies and immune vasculitides. Basic research is conducted to investigate the molecularbiological causes of the inappropriate immune response. The network also carries out assessments of healthcare services, on the basis of a unique patient database storing records of 31,000 adults and 3,500 children annually, as a means of identifying possible target areas for improvement.

NETWORK COORDINATOR Rheumatology Competence Network Central Business Office c/o German Rheumatism Research Center Spokesman: Prof. Dr. Andreas Radbruch Coordinator: Dr. Cornelia Rufenach Schumannstrasse 21 / 22 D-10117 Berlin Phone: +49 (0) 30 / 4 50 51 33 72 Fax: +49 (0) 30 / 4 50 51 39 88 E-Mail: [email protected] www.rheumanet.org 22

Spine of a patient suffering from Bechterev's disease: As the MRI images show, the new anti-TNF-alpha therapy stops the harmful inflammation (red) caused by the disease. From left to right: Initial stage; after 12 weeks therapy; after 54 weeks therapy.

Reliable diagnosis and more effective therapies ”I’m very sorry, you have rheumatoid arthritis. I’m afraid there’s nothing we can do about it.” Many patients have heard this sobering statement from their doctors, who until recently were unable to alleviate their patient’s suffering or to slow progress of the disease, due to the lack of effective treatments. But today things are different. No other branch of medicine has made such rapid progress in recent years. This is largely due to collaboration between clinical rheumatologists and research scientists, as exemplified by the Rheumatology Competence Network. Significant advances have been made, which are now being transferred to patient care and treatment: New treatment for Bechterev’s disease Clinical scientists in the network have recently shown that a genetically engineered antibody against the proinflammatory cytokine tumor necrosis factor alpha (TNF-) can be successfully used to treat patients suffering from Bechterev’s disease (ankylosing spondylitis). More than 80% of patients who received therapy over a three-month period experienced a significant improvement in their clinical symptoms. In 50% of these cases, the new drug infliximab reduced disease activity by more than half. Improved diagnosis of rheumatoid arthritis Is it rheumatoid arthritis or not? This question is difficult to answer in the early stages of the disease. A network project has however established that certain

molecular structures present in a patient’s cartilage tissue act as auto-antigens. As a result, a routine diagnostic procedure should soon be available that facilitates identification of the disease in its early stages. Diagnosis of nonspecific arthritis Using the Rheumatology Competence Network reference laboratory, specialists and doctors will soon be able to diagnose nonspecific forms of arthritis. Accordingly, analysis of joint tissue or synovial fluid for Chlamydia is already available and one for Borrelia is anticipated. Specialist attention pays dividends Only around 20% of all rheumatoid arthritis patients are seen by specialists, according to an analysis of patient records. However, it has been established that when patients are treated by specialists their prognosis significantly improves. Stem cell transplantation for auto-immune diseases Research scientists working in the network have recently developed a novel stem cell treatment for patients suffering from systemic lupus erythematosus (SLE). The patient’s immune system is destroyed by high-dose chemotherapy. Patients then receive some of their own blood stem cells (previously withdrawn), which facilitate the rebuilding of the immune system. Although the procedure is still being tested and refined, several successful trials have been carried out. The study strongly suggests – for the first time – that a rheumatic disease can possibly be completely cured.

www.kompetenznetze.de > Fields of Innovation > Medicine

Schizophrenia

Constant progress in all aspects of care A targeted choice of the appropriate pharmacological and psychotherapeutic treatments for schizophrenia, backed by specialized psychosocial care, makes it possible to reduce the severity of symptoms and prevent relapses in 70% of cases. But treatment is often not sought or commenced until several years after the onset of the disease, and is not always carried out according to recommended guidelines. Nor is treatment always adapted to the specific needs of first-episode patients. This is where the research network hopes to bring about improvements. A checklist of common early symptoms The network has set up the first four national early-detection centers, to allow suspected cases of schizophrenia to be correctly diagnosed at the earliest possible stage, and treatment started where necessary. A checklist of common early symptoms has been distributed to local networks of schools, general practitioners and advice centers, to help identify persons at risk. A special psychotherapy manual has been compiled for the treatment of firstepisode patients. A comparative pharmacological study has demonstrated that low doses of drugs with fewer side effects can significantly relieve many symptoms.

vance of guidelines) are capable of significantly ameliorating outcome. The network has developed special guidelinebased documentation software for use in outpatient work. Content is being contributed by professional associations of neurologists, psychiatrists and other specialized competence networks, enabling the software to be further developed and integrated in routine care programs. New strategies New rehabilitation strategies have been developed and positively evaluated to remediate impairments in emotional perception. Since impairments significantly contribute to the schizophrenia patients' poor ability to function in a social context, such new treatment strategies aim to facilitate patients' social integration. To gain a better understanding of the underlying causes of the disease and biological factors that modulate its progression, a gene bank is being set up to study fundamental neurobiological aspects in more detail.

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A network for people

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Schizophrenia is a severe psychotic disorder that affects approximately 1% of the world’s population at least once during their lives. The illness has a tendency to become chronic, and causes a great deal of suffering to affected individuals and their families. The direct and indirect costs of schizophrenia in Germany are estimated at about 3.5 billion euros per year. The aims of the research network are to: • detect symptoms and commence treatment at an early stage, • apply existing therapeutic treatments and improve them, • prevent the illness from taking a chronic course, • optimize care and treatment through quality management and knowledge transfer, • reduce stigmatization and discrimination, and to improve the research infrastructure, for instance by building up databases.

Although schizophrenia patients are still often subject to social discrimination, the international campaign ”open the doors” is beginning to have an effect, proving that prejudices can be overcome by promoting awareness and social contact (e.g. public lectures and discussions).

Guideline-based documentation software Quality management programs in the outpatient and inpatient care of schizophrenia patients show that quality assurance strategies (benchmarking, obser-

Typical progression charts of schizophrenia psychoses

NETWORK COORDINATOR Prof. Dr. Wolfgang Gaebel (spokesman) Head Office: Department of Psychiatry, University Dusseldorf Rhineland State Clinics Dusseldorf Bergische Landstrasse 2 D-40629 Düsseldorf Phone: +49 (0) 2 11 / 9 22 - 27 70 Fax: +49 (0) 2 11 / 9 22 - 27 80 E-Mail: [email protected] www.kompetenznetz-schizophrenie.de www.psychosenetz.de 23

www.kompetenznetze.de > Fields of Innovation > Medicine

SepNet – Sepsis

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Sepsis is a major challenge for medicine and the health care system

SepNet is the world’s largest independent research network devoted to sepsis, representing 15 regional centers in Germany and 8 affiliated hospitals, who treat 30,000 critically ill patients each year. SepNet aims to reduce the present high mortality rate by: • creating efficient structures for advanced clinical trials in sepsis research, • launching and conducting innovative, internationally competitive studies under professional management, • introducing the concept of evidence-based knowledge into clinical practice in Germany.

The ‘backbone’ of SepNet: regional centers and associated hospitals.

SepNet – Research platform for multi-center studies in Germany In the USA, around 263,000 deaths are caused by sepsis each year, which is more than the number of deaths attributable to acute myocardial infarction. This represents an annual incidence of 300 cases per 100,000 population. The comparable figures for new cases of colorectal cancer and breast cancer are 50 and 110 respectively. The annual toll of sepsis cases in Germany lies between 44,000 and 95,000, resulting in estimated direct medical costs of around 2.45 billion euros.

(475 critical-care units) throughout Germany. Over 4,000 patients have been screened, and the first results are expected in mid-2004.

BMBF funding has been secured for the initial phase of setting up a sepsis competence network (for 3 years from February 2002), and a further total of 1.6 million euros has been contributed by industrial research sponsors, for the conduct of studies.

Whereas present-day sepsis research focuses mainly on adjunctive therapeutic approaches, the value of individual, supportive, usually lower-cost treatment strategies has never been investigated. The VISEP study is the world’s first to study the question of which volume replacement approach or which type of insulin therapy should be used for sepsis patients in future. So far, 200 out of a planned 600 patients have been recruited for the study.

Current projects: • Prevalence study • VISEP study • Central Specimen Bank NETWORK COORDINATOR Prof. Dr. med. Konrad Reinhart Klinikum der FSU Jena Klinik für Anästhesiologie und Intensivtherapie Phone: +49 (0) 36 41 / 932 3381 Fax: +49 (0) 36 41 / 934 795 E-Mail: [email protected]

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”Prevalence of severe sepsis and septic shock in German critical-care units (Prevalence study)” This prospective, interdisciplinary, epidemiological multi-center observation study is the first in Germany to gather valid, representative data on the frequency, morbidity and mortality of sepsis, the healthcare structure, diagnostic and therapeutic methods, and related costs. The survey was carried out on the basis of a representative sample of hospitals

”Prospective, randomized, multi-center study on the effect of colloid vs. crystalloid volume replacement therapy and of intensive vs. conventional insulin therapy on organ functions and survival in patients with severe sepsis and septic shock (VISEP study)”

Central Specimen Bank The third SepNet project is to set up large-scale specimen banks for the investigation of genomic, proteomic and molecular-biological factors. The mediumterm aim is to enable fast, reliable diagnosis and to identify new therapeutic avenues (risk assessment, target identification).

www.kompetenznetze.de > Fields of Innovation > Medicine

Stroke

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Almost 200,000 people suffer a stroke in Germany every year. The Stroke competence network aims to assist such people in a realistic, practical way by making the latest, practice-oriented research findings available.

The latest MRI techniques improve diagnosis following a stroke.

Stroke patients need efficient help During a stroke the blood supply to a part of the brain is lost and the brain tissue in that area may cease to function. The most common cause is a blood clot or, less frequently, rupture of a blood vessel supplying blood to the brain. In Germany, a stroke is the third most common cause of death and the most common cause of acquired disability in adults. Many stroke patients suffer paralysis, sight or speech defects and are therefore completely reliant on daily care. Breakthrough in acute therapy The higher resolution of the latest MRI techniques now makes it easier to differentiate between non-functional and functional brain tissue in stroke patients. This in turn facilitates the administration of a drug treatment called lysis therapy, which dissolves blood clots in the brain. The improved diagnostic procedure, now available in many German clinics, gives medical staff more time to apply treatment in the critical three hours following the onset of symptoms, and thus in many cases prevent severe disability. Expanding knowledge through shared databases The competence network has helped to create the first nationwide research groups devoted to stroke prevention, acute therapy, rehabilitation and healthcare. To share their knowledge of imaging techniques and epidemiological or genetic data, collaborating teams of scientists and clinicians have set up spe-

cialized stroke databases, based on newly developed common standards. They now possess one of the largest databases being used to study genetic factors influencing susceptibility to stroke. Mutations associated with a high stroke risk have been identified in four genes. Such findings will eventually be used to identify high-risk individuals and devise more personalized treatment. Another research group collates and evaluates data from nearly 40,000 stroke patients each year, providing a solid basis for comparing the effectiveness of different treatments on a national scale – another example of expanding knowledge through sharing.

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Healthcare organizations have been working together with clinical and research scientists in this BMBFsupported, nationwide competence network since 1999. The aim is to pool the expertise of the leading research groups participating in the network, in addition to improving the flow of information between scientists, physicians and patients. Consequently, more rapid progress in this research field should be made and the implementation of research findings in healthcare practice should be more effective. The network’s 29 interdisciplinary projects seek to optimize identification of high-risk individuals, preventative measures, diagnosis and acute therapy, patient rehabilitation and aftercare. A stroke results in a sudden loss of function of certain areas in the brain.

Improving healthcare ‘Every minute counts’ after a stroke, as brain cells begin to die almost immediately. Nevertheless, many stroke patients seek medical attention too late. A study group is looking into the question of why this is so, and how to avoid this unnecessary suffering. Their results indicate a curious discrepancy between theory and practice: Many previous stroke victims fail to learn from experience and, although they recognize the symptoms, seek medical attention even later when they recur.

NETWORK COORDINATOR www.kompetenznetz-schlaganfall.de Network coordinator: Prof. Dr. A. Villringer Neurologische Klinik, Charité, Schumannstrasse 20/21 D-10117 Berlin Phone: +49 (0) 30 / 4 50 56 00 34 Fax: +49 (0) 30 / 4 50 56 09 52 E-Mail: [email protected] Contact: Dipl.-Biol. L. Clevert, Phone: +49 (0) 30 / 4 50 56 01 45 E-Mail: [email protected] 25

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www.kompetenznetz-medizin.de www.kompetenznetz-ahf.de www.brain-net.net www.capnetz.de www.kompetenznetz-ced.de www.kompetenznetz-demenzen.de www.kompetenznetz-depression.de www.kompetenznetz-hepatitis.de www.kompetenznetz-herzinsuffizienz.de www.kompetenznetz-hiv.de www.kompetenznetz-leukaemie.de www.lymphome.de www.kinderkrebsinfo.de www.kompetenznetz-parkinson.de www.rheumanet.org www.kompetenznetz-schizophrenie.de www.kompetenznetz-schlaganfall.de www.sepnet.de www.kompetenznetz - vorhofflimmern . de

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