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Presentation template of the Competence Network (English)
Presentation template of the Competence Network (English)
Presentation template of the Competence Network (English)
Presentation template of the Competence Network (English)
Presentation template of the Competence Network (English)
Presentation template of the Competence Network (English)
Presentation template of the Competence Network (English)
Presentation template of the Competence Network (English)
Presentation template of the Competence Network (English)
Presentation template of the Competence Network (English)
Presentation template of the Competence Network (English)
Presentation template of the Competence Network (English)
Presentation template of the Competence Network (English)
Presentation template of the Competence Network (English)
Presentation template of the Competence Network (English)
Presentation template of the Competence Network (English)
Presentation template of the Competence Network (English)
Presentation template of the Competence Network (English)
Presentation template of the Competence Network (English)
Presentation template of the Competence Network (English)
Presentation template of the Competence Network (English)
Presentation template of the Competence Network (English)
Presentation template of the Competence Network (English)
Presentation template of the Competence Network (English)
Presentation template of the Competence Network (English)
Presentation template of the Competence Network (English)
Presentation template of the Competence Network (English)
Presentation template of the Competence Network (English)
Presentation template of the Competence Network (English)
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Presentation template of the Competence Network (English)

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  • As each individual research center in Germany treats only small numbers of patients, no comprehensive data are available concerning the epidemiology and long-term course of CHDs. Multicenter studies have so far been rare. We started with multicenter studies investigating problems of the pulmonary system and right heart failure. There are 5 main projects and 4 cross-sectional projects. The purpose of the multicenter clinical studies is manifold: - to indicate and promote the spirit of cooperation, - to create a study design that allows multiple use of the same data set, - to develop standards for the most commonly used non-invasive methods, - to develop a methodology for quantification of size and function of the right ventricle, - to acquire basic knowledge of the ventricular response to different types of overload, - to establish standardized “normal reference values” for the most common methods used in the clinical routine and - to set the stage for long-term clinical studies.
  • All main projects use the same basic data set and every study has own specific parameters. All data are transferred to a central database. Thus, we can perform very different analyses with the results. Clinical long-term studies are the final goal of the Competence Network for CHDs. As a first step towards that goal, two identical standardized data sets shall be acquired of each studied patient during the first and second funding period. This means that about 2,000 high quality data sets will be available for comparative long-term evaluation of the same patients beyond the funding periods. Using the same standardized diagnostic tools, further long-term studies shall be initiated on the basis of the results of the present studies. The focus will be on the question of what impact the initial operation or intervention has on the long-term outcome and how the initial treatment can be altered to improve life expectancy and quality of life.
  • What about the fitness and constitution?
  • What about the fitness and constitution?
  • Due to fundamental progress made in the fields of pediatric cardiology, cardiac surgery and anesthesia in the past few decades, today, approximately 90 % of the patients will reach adulthood.
  • As I already mentioned, we estimate that every year 6000 children are born with CHDs. And we know that 90 % reach adulthood. As the calculation shows, the clinical relevance of CHD will increase significantly in the coming years. Accordingly, the number of adult patients with CHDs is rising steadily and these patients require specialized treatment and health care structures.
  • You know that CHD are the most frequent congenital illness. Each year, about 6000 children are born with such a defect in Germany. Most of them, 70 percent to be precise, will be chronically ill throughout their lifetimes. This generally means considerable suffering for the person concerned and for the whole family.
  • After the first registration, we send a questionnaire asking the patients: What is the diagnosis? What kind of operation and/or intervention did you have? How do you assess your own state of health? Are there other family members of the patient who have a CHD?
  • The National Register for CHDs is recognized as an uncommercial scientific association and was founded by the German specialized societies for pediatric cardiology, cardiology and heart surgery. Thus, both the Competence Network itself and the register as its core project are closely connected to and supported by the relevant medical societies.
  • This year, we will also start Europe-wide clinical projects.
  • We receive active support by the self-help groups and parent organizations. They encourage those affected to participate in the studies and to enrol in the registry. We closely cooperate with the self-help groups to achieve a swift transfer of knowledge between research and practice. Thus, on the one hand, research benefits from information about problems patients face in everyday life; on the other hand, the patients and their attending physicians can be currently provided with the most recent research findings.
  • We receive active support by the self-help groups and parent organizations. They encourage those affected to participate in the studies and to enrol in the registry. We closely cooperate with the self-help groups to achieve a swift transfer of knowledge between research and practice. Thus, on the one hand, research benefits from information about problems patients face in everyday life; on the other hand, the patients and their attending physicians can be currently provided with the most recent research findings.
  • Patients, parent organizations and self-help groups are showing their support for the Register by their active participation. They are vitally interested in the questions of long-term experience with heart defects and the quality of life to be expected. The willingness of patients to give the Register their full data and to participate in studies is very high.
  • The structure of the IT network is very complex (as you can see). The areas of the clinical studies are connected to those of the National Register. A GCP conform study database is used fort he clinical studies. The personal data are entered into a special data base system, where a unique person identifier (PID) is generated, which prevents patients from being registered twice. The PID is then assigned to the medical or epidemiological data that are entered into the study data base. After the studies have been completed, the person identifier is coded once more, which means the data are pseudonymized. After that the data can be analyzed with respect to different questions by different scientists.
  • The structure of the IT network is very complex (as you can see). The areas of the clinical studies are connected to those of the National Register. A GCP conform study database is used fort he clinical studies. The personal data are entered into a special data base system, where a unique person identifier (PID) is generated, which prevents patients from being registered twice. The PID is then assigned to the medical or epidemiological data that are entered into the study data base. After the studies have been completed, the person identifier is coded once more, which means the data are pseudonymized. After that the data can be analyzed with respect to different questions by different scientists.
  • Transcript

    • 1. Research for People Title
    • 2. Structure of the Network RESEARCH PROJECTS NATIONAL REGISTER ADVISORY BOARD SELF-HELP GROUPS + PARENT ORGANIZATIONS REHABILITATION CENTERS GENERAL PRACTITIONERS NETWORK OFFICE RESEARCH INSTITUTIONS HEART SURGEONS CARDIOLOGISTS PATIENTS PUBLIC RELATIONS HORIZONTAL RESEARCH NETWORK VERTICAL RESEARCH AND HEALTH CARE NETWORK PEDIATRIC CARDIOLOGISTS UNIVERSITY HOSPITALS/ HEART INSTITUTES
    • 3. Network Research GENDER EPIDEMIOLOGY HEALTH CARE RESEARCH NON-INVASIVE RV IMAGING SUBJECTIVE EXERCISE TOLERANCE OBJECTIVE EXERCISE TOLERANCE NEW PROJECTS STANDARDIZATION GUIDELINES EDUCATION PUBLIC RELATIONS MYOCARDIUM RV- HEART FAILURE CENTRAL DATABASE + REGISTER AFTER-LOAD PULMONARY ARTERIOPATHY COMBINED-LOAD FALLOT-TETRALOGY AFTER-LOAD THERAPY PULMONARY ARTERIOLOPATHY AFTER-LOAD PULMONARY ARTERIOPATHY
    • 4. Standardised Study Schedule Patients with Basic data base Basic data base
        • Tetralogy of Fallot
        • Peripheral pulmonary stenosis
        • Pulmonary hypertension
        • Right ventricular failure
      Clinical examination MRI Echocardiography Objective exercise tolerance Subjective exercise tolerance Gender-specific aspects Specific parameters Specific parameters Time in months Central data base 0 12 Clinical examination MRI Echocardiography Objective exercise tolerance Subjective exercise tolerance Gender-specific aspects
    • 5. Research for Health
    • 6. Research for Health
    • 7. Survival Rate of Children with CHD survival rate (%) year
    • 8. Estimated Clinical Relevance of CHD in the next Years years patients (n) Live births with CHD (0,8 % of all live births) Children with CHD (90 % of live births with CHD) 18-year-olds with CHD (80 % of children with CHD) Adults with CHD
    • 9. Congenital Heart Defects
      • Most common malformation in humans
      • 0,7 - 1 % of all life births
      • Variety of malformations of the heart and the great arteries
      • 30 % mild, 45 % moderate, 25 % severe defects
      • Great suffering for those affected and the whole family
    • 10. The Minimal Data Set Diagnosis Operation/s (kind, date, location) Intervention/s (kind, date, location) Self assessment Family history
    • 11. National Register for CHD Founded by German associations
    • 12. Next Steps Studies with
    • 13. Support of the Competence Network for Congenital Heart Defects By Patients and Self-help Groups Bundesverband Herzkranke Kinder e. V.
    • 14. Support of the Competence Network for Congenital Heart Defects Herzkind e. V. Interessengemeinschaft Das herzkranke Kind e. V. (IDHK) Bundesvereinigung JEMAH e. V. By Patients and Self-help Groups
    • 15. Consent of Parents/Patients to participate in Studies [National Register for Congenital Heart Defects, 03/2007, n = 24,076] yes 97 % no 3 %
    • 16. IT-Infrastructure
    • 17. Data Protection Remote data entry PID-Generator Patientlist Pseudonym generating service Research database Study database
    • 18. Internal Executive Committee Prof. Dr. med. Peter E. Lange (Speaker) Dr. med. Ulrike Bauer (Managing Director) Prof. Dr. med. Matthias Gutberlet Prof. Dr. med. Hans-Werner Hense PD Dr. Siegfried Kropf PD Dr. med. Brigitte Stiller
    • 19.
      • Executive Board 2003 - 2006
      National Register for CHD Prof. Dr. med. Günter Breithardt (Vice Chairman) Prof. Dr. med. Sabine Däbritz Dr. med. Fokko de Haan Prof. Dr. med. Dr. h.c. mult. Roland Hetzer Prof. Dr. med. Marie-Christin Seghaye Dr. med. Karl Robert Schirmer Prof. Dr. med. Achim A. Schmaltz (Chairman) DGK DGTHG DGK/BNK DGTHG DGPK DGPK/ANKK DGPK
    • 20. National Register for CHD
      • Executive Board 2007 - 2009
      Prof. Dr. med. Günter Breithardt (Chairman) Prof. Dr. med. Sabine Däbritz Dr. med. Fokko de Haan Prof. Dr. med. Roland Hetzer (Vice Chairman) Prof. Dr. med. Deniz Kececioglu Dr. med. Karl Robert Schirmer Prof. Dr. med. Achim A. Schmaltz DGK DGTHG DGK/BNK DGTHG DGPK DGPK/ANKK DGPK
    • 21.
      • Appointed by the Federal Ministry of Education and Research/German Aerospace Center
      • Prof. Dr. med. Frank A. Flachskampf (Echocardiography)
      • Prof. Dr. med. Johannes Haerting (Epidemiology and Biometrics) – Vice Chairman
      • Prof. Dr. med. Martin Otto Hess (Cardiology)
      • Prof. Dr. med. Hans Carlo Kallfelz (Pediatric Cardiology) – Chairman
      • Prof. Dr. med. Rüdiger Klar (Biometrics und Informatics)
      • Prof. Dr. med. Ingrid Oberhaensli-Weiss (Pediatric Cardiology)
      • Prof. Dr. med. Erwin Notker Oechslin (Cardiology)
      • Prof. Dr. med. Ursula Ravens (Pharmacology)
      • Prof. Dr. med. Rainer Rienmüller (Radiology)
      • Prof. Dr. med. Berthold Schneider (Biometrics und Informatics)
      • Prof. Dr. med. Götz von Bernuth (Pediatric Cardiology)
      Advisory Board
    • 22. National Register for CHD Purpose according to charter Collection of data of patient with CHD
      • for epidemiological studies
      • as starting base for clinical studies
    • 23. Data Protection Requirements
      • Economical responsible for long-time projects
      • Patient information/-consent
      • Protection of person-related data
      • Definition of the objectives of the Register
    • 24. National Register for CHD
      • This Register is to function as a link between pediatric cardiologists, heart surgeons, epidemiologists and social physicians to form a basis for efficient research.
      • Valid data from the Register can be an essential contribution to health research concerning a patient group with a chronic illness that has an major impact on each individuals's life.
    • 25. Funded Projects 2 nd Period Epidemiological projects EP 1.0 EP 1.1 EP 1.2 EP 1.3 EP 1.4 EP 1.5 EP 2.0 National Register for congenital heart defects (registered association) Family-based investigation of the genetic causes Integrated Project – Heart Failure and Cardiac Repair (HeartRepair) Sense of coherence as mediator of health-related quality of life in adolescents with congenital heart disease (CoalaH) Quality of life and social situation of adult patients (LESSIE) Living with congenital heart defects – creating patient empowerment by new ways of communication Prevalence of congenital heart defects in newborns in Germany (PAN)
    • 26. Funded Projects 2 nd Period Clinical Studies HP 3.1 HP 3.3 HP 4.2 HP 4.3 NP 4 Therapy of the pulmonary artery hypertension with Sildenafil in Eisenmenger patients Bosentan for decrease of pulmonary artery resistance after Fontan operation Early reintervention in children after repair of tetralogy of Fallot: Prospective analysis of „timing“ and efficacy using cardia MRI and tissue Doppler indices Multicentric prospective analysis of factors influencing the results of corrective operation in tetralogy of Fallot Cardial resynchronisation therapy for treatment of patients with cardiac insufficiency and congenital heart defects – new therapeutical approaches
    • 27. Research for People www.kompetenznetz-ahf.de
    • 28. www.kompetenznetz-ahf.de
    • 29. www.kompetenznetz-ahf.de

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