{"id":203,"date":"2023-03-29T14:08:46","date_gmt":"2023-03-29T12:08:46","guid":{"rendered":"https:\/\/immunoregister.de\/cedur\/"},"modified":"2023-05-02T14:10:12","modified_gmt":"2023-05-02T12:10:12","slug":"cedur","status":"publish","type":"page","link":"https:\/\/immunoregister.de\/en\/cedur\/","title":{"rendered":"CEDUR"},"content":{"rendered":"
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In Germany, about 350,000 patients suffer from inflammatory bowel disease (unofficial estimates of health insurance companies rather assume 440,000 affected persons (BARMER Report “Gesundheitswesen aktuell”, A. Stallmach et al. 2012)). Exact data on prevalence and incidence are not available in Germany. However, the incidence and prevalence of IBD are increasing worldwide, demonstrating the growing relevance of these diseases, also in terms of health economics.<\/p>\n

(Molodecky, N.A.et al, ,,Increasing incidence and prevalence of the inflammatory bowel disease with time, based on systemic review” Gastroenterology 2012; 142 ( 1)).
\nIn principle, inflammatory bowel diseases are excellent treatable with appropriate drugs, depending on activity and disease progression. In recent years, new, innovative and highly effective therapies (biologics \/ small molecules) have been introduced to the healthcare market. These new therapies require highly qualified medical expertise and a considerable amount of time for treatment.
\nRecent data show that especially the young patient group in the early or mid-life stages receives suboptimal treatment. On average, it still takes about two years from the onset of the first symptoms to the correct diagnosis. This can already lead to irreversible damage to the gastrointestinal tract.
\nDespite excellent data, a significant proportion of affected patients are still treated with steroids over a long period of time, immunosuppressive drugs are rarely used, as well as biologics. (Blumenstein, I. et al. “Health Care and Cost of Medication for Inflammatory Bowel Disease in the Rhein-Main Region, Germany: A Multicenter Prospective, Internet-based Study.” InflammBowel Dis 2008; 14(2)).<\/p>\n

By early and consistent implementation of current treatment guidelines, patients could achieve a high level of well-being and possible long-term sequelae could be prevented. In addition, unnecessary costs for therapies, hospitalizations, and surgeries could be avoided. Finally, fewer incapacities to work and early retirements would relieve the national economy.
\nTo achieve this, it is a prerequisite to establish and record standardized and practicable ways to improve patient care.<\/p>\n

For this reason, the first independent, national IBD registry “CEDUR” (“Chronic Inflammatory Bowel Disease, an Independent Registry”) was established to enable improved health care research, e.g. by methodically collecting data on therapy effects, real treatment courses including costs, pharmacoeconomic costs and incidence \/ prevalence of IBD in Germany.<\/p>\n<\/div><\/div><\/div><\/div><\/div>

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Objectives:<\/strong><\/p>\n

    \n
  • To evaluate and improve the quality of care for patients with IBD<\/li>\n
  • Description of long-term efficacy of CED therapies, e.g. patient journey, efficacy\/side effects of treatment combinations, disease activity<\/li>\n
  • Description and visualization of treatment pathways and disease trajectories.<\/li>\n
  • Application of national CED guidelines<\/li>\n
  • Assessment of incidence and prevalence of IBD<\/li>\n
  • Real treatment costs \/ pharmaceutical economic costs<\/li>\n
  • Long-term effectiveness of treatments based on established outcome measures<\/li>\n
  • Comparison of treatment strategies based on established endpoint measures<\/li>\n
  • Improved and time-saving documentation in medical records (individual practice\/hospital management software, e.g., AIS via GDT interface).<\/li>\n
  • Improved and time-saving reporting process of SAW (“serious adverse drug events”) and AESI (AE of special interest).<\/li>\n
  • The registry will collect safety data on all available therapies for CED.<\/li>\n
  • In addition, CEDUR will collect adverse events of special interest and SAW to assess the overall safety profile:<\/li>\n
  • A baseline and follow-up data set will be collected to summarize the course and outcome of pregnancies on medication.<\/li>\n<\/ul>\n<\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/section>

    Inclusion criteria:<\/strong><\/p>\n

      \n
    • Diagnosis of Crohn’s disease, ulcerative colitis, or indeterminate colitis.<\/li>\n
    • Age \u226518 years<\/li>\n<\/ul>\n

      Exclusion criteria:<\/strong><\/p>\n

        \n
      • Gastrointestinal disease other than Crohn’s disease, ulcerative colitis, indeterminate colitis<\/li>\n
      • Age <18 years<\/li>\n<\/ul>\n

        Methods:<\/strong>
        \nCEDUR is a web-based, descriptive, multicenter registry.
        \nPhysicians wishing to participate in CEDUR must sign a contract with ImmunoRegister gemeinn\u00fctzige UG. The goal is to follow each patient for at least five years, and ten years or more if possible.
        \nPatients fill out questionnaires once a quarter. This can either be done in the respective CEDUR site or the patient fills in the data from home on an internet-enabled device.
        \nThe physician \/ CED nurse then completes a few details. With the appropriate software, it is possible to transfer the data of the respective patients into the physician information system of the center. In this way, important data such as stool frequency, abdominal pain, current medication, etc. are available in real time even before the patient consultation. This means that important data, such as stool frequency, abdominal pain, current medication, etc., is available in real time before the patient consultation and no longer has to be documented separately in the patient’s file by the physician. This provides a relevant time saving for the physician.
        \nThe coordinating investigator, the scientific advisory board or the pharmaceutical companies sponsoring the registry have no influence on treatment decisions.
        \nThe type of treatment administered and the delivery of individual therapy, including dosage, will be determined solely by the treating physician.<\/p>\n

        Ethics & Privacy:
        \n<\/strong>The CEDUR registry has received data protection advice from the Hamburg data protection officer and has received the approving ethics vote from the ethics committee of the Hamburg Ethics Committee.<\/p>\n

        Recruitment status:<\/strong>
        \nCurrent status of enrolled patients: 3,520 (as of April 2023).<\/p>\n<\/div><\/div><\/div><\/div><\/div>

        <\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/section>\n","protected":false},"excerpt":{"rendered":"[vc_custom_heading text=\"CEDUR\" font_container=\"tag:h1|text_align:center\" use_theme_fonts=\"yes\"][vc_custom_heading text=\"Background\" use_theme_fonts=\"yes\"]In Germany, about 350,000 patients suffer from inflammatory bowel disease (unofficial estimates of health insurance companies rather assume 440,000 affected persons (BARMER Report “Gesundheitswesen aktuell”, A. Stallmach et al. 2012)). Exact data on prevalence and incidence are not available in Germany. However, the incidence and prevalence of IBD are increasing...","protected":false},"author":4,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-203","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/immunoregister.de\/en\/wp-json\/wp\/v2\/pages\/203","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/immunoregister.de\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/immunoregister.de\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/immunoregister.de\/en\/wp-json\/wp\/v2\/users\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/immunoregister.de\/en\/wp-json\/wp\/v2\/comments?post=203"}],"version-history":[{"count":5,"href":"https:\/\/immunoregister.de\/en\/wp-json\/wp\/v2\/pages\/203\/revisions"}],"predecessor-version":[{"id":348,"href":"https:\/\/immunoregister.de\/en\/wp-json\/wp\/v2\/pages\/203\/revisions\/348"}],"wp:attachment":[{"href":"https:\/\/immunoregister.de\/en\/wp-json\/wp\/v2\/media?parent=203"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}