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- Burisch, Johan, et al.
(author)
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Construction and validation of a web-based epidemiological database for inflammatory bowel diseases in Europe An EpiCom study
- 2011
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In: JOURNAL OF CROHNS and COLITIS. - : Elsevier Science B.v; Amsterdam. - 1873-9946 .- 1876-4479. ; 5:4, s. 342-349
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Journal article (peer-reviewed)abstract
- Background: The EpiCom-study investigates a possible East-West-gradient in Europe in the incidence of IBD and the association with environmental factors. A secured web-based database is used to facilitate and centralize data registration. Aim: To construct and validate a web-based inception cohort database available in both English and Russian language. Method: The EpiCom database has been constructed in collaboration with all 34 participating centers. The database was translated into Russian using forward translation, patient questionnaires were translated by simplified forward-backward translation. Data insertion implies fulfillment of international diagnostic criteria, disease activity, medical therapy, quality of life, work productivity and activity impairment, outcome of pregnancy, surgery, cancer and death. Data is secured by the WinLog3 System, developed in cooperation with the Danish Data Protection Agency. Validation of the database has been performed in two consecutive rounds, each followed by corrections in accordance with comments. Results: The EpiCom database fulfills the requirements of the participating countries local data security agencies by being stored at a single location. The database was found overall to be "good" or "very good" by 81% of the participants after the second validation round and the general applicability of the database was evaluated as "good" or "very good" by 77%. In the inclusion period January 1st -December 31st 2010 1336 IBD patients have been included in the database. Conclusion: A user-friendly, tailor-made and secure web-based inception cohort database has been successfully constructed, facilitating remote data input. The incidence of IBD in 23 European countries can be found at www.epicom-ecco.eu. (C) 2011 European Crohns and Colitis Organisation. Published by Elsevier B.V. All rights reserved.
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| 2. |
- Burisch, Johan, et al.
(author)
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Initial Disease Course and Treatment in an Inflammatory Bowel Disease Inception Cohort in Europe : The ECCO-EpiCom Cohort
- 2014
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In: Inflammatory Bowel Diseases. - : Lippincott Williams & Wilkins. - 1078-0998 .- 1536-4844. ; 20:1, s. 36-46
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Journal article (peer-reviewed)abstract
- Background:The EpiCom cohort is a prospective, population-based, inception cohort of inflammatory bowel disease (IBD) patients from 31 European centers covering a background population of 10.1 million. The aim of this study was to assess the 1-year outcome in the EpiCom cohort.Methods:Patients were followed-up every third month during the first 12 (3) months, and clinical data, demographics, disease activity, medical therapy, surgery, cancers, and deaths were collected and entered in a Web-based database (www.epicom-ecco.eu).Results:In total, 1367 patients were included in the 1-year follow-up. In western Europe, 65 Crohn's disease (CD) (16%), 20 ulcerative colitis (UC) (4%), and 4 IBD unclassified (4%) patients underwent surgery, and in eastern Europe, 12 CD (12%) and 2 UC (1%) patients underwent surgery. Eighty-one CD (20%), 80 UC (14%), and 13 (9%) IBD unclassified patients were hospitalized in western Europe compared with 17 CD (16%) and 12 UC (8%) patients in eastern Europe. The cumulative probability of receiving immunomodulators was 57% for CD in western (median time to treatment 2 months) and 44% (1 month) in eastern Europe, and 21% (5 months) and 5% (6 months) for biological therapy, respectively. For UC patients, the cumulative probability was 22% (4 months) and 15% (3 months) for immunomodulators and 6% (3 months) and 1% (12 months) for biological therapy, respectively in the western and eastern Europe.Discussion:In this cohort, immunological therapy was initiated within the first months of disease. Surgery and hospitalization rates did not differ between patients from eastern and western Europe, although more western European patients received biological agents and were comparable to previous population-based inception cohorts.
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| 5. |
- Borg, Sixten, et al.
(author)
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A maximum likelihood estimator of a Markov model for disease activity in Crohn's disease and ulcerative colitis for annually aggregated partial observations.
- 2010
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In: Medical Decision Making. - 1552-681X. ; 30:1, s. 42-132
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Journal article (peer-reviewed)abstract
- Crohn's disease (CD) and ulcerative colitis (UC) are chronic inflammatory bowel diseases that have a remitting, relapsing nature. During relapse, they are treated with drugs and surgery. The present study was based on individual data from patients diagnosed with CD or UC at Herlev University Hospital, Copenhagen, Denmark, during 1991 to 1993. The data were aggregated over calendar years; for each year, the number of relapses and the number of surgical operations were recorded. Our aim was to estimate Markov models for disease activity in CD and UC, in terms of relapse and remission, with a cycle length of 1 month. The purpose of these models was to enable evaluation of interventions that would shorten relapses or postpone future relapses. An exact maximum likelihood estimator was developed that disaggregates the yearly observations into monthly transition probabilities between remission and relapse. These probabilities were allowed to be dependent on the time since start of relapse and on the time since start of remission, respectively. The estimator, initially slow, was successfully optimized to shorten the execution time. The estimated disease activity model for CD fits well to observed data and has good face validity. The disease activity model is less suitable for UC due to its transient nature through the presence of curative surgery.
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| 6. |
- Halfvarson, Jonas, 1970-, et al.
(author)
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Biologics forever
- 2010
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In: Scandinavian Journal of Gastroenterology. - 0036-5521 .- 1502-7708. ; 45, s. 90-90
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Journal article (other academic/artistic)abstract
- Introduction: The introduction of biologics has changed the concept of treating IBD and especially CD. TNF-inhibitors have been shown to reduce hospitalization and the need of surgery. Furthermore, the benefi t of TNF-inhibitors seem to be more pronounced in fairly newly diagnosed patients, than in patients that have suffered from CD for many years. However, it is still unknown whether early ”aggressive” treatment with biologics can change the natural course of IBD, including achieving a deep long-term remission and in CD avoiding progression to complicated disease behaviour. The aims of the talk are to discuss different potential treatment strategies with respect to biologics and to examine the evidence for continuing or stopping treatment with biologics.Methods: Literature search of the topic was performed using Medline/Pubmed and the Cochrane database.Results: Recent studies suggest that mucosal healing is associated with longstanding remission also in CD. Evidence comes from both epidemiological studies and randomized control trials. In the population based IBSEN study, patients diagnosed with IBD 1990-1994, before the introduction of biologics, were included. Patients with CD achieving mucosal healing after one year, had less infl ammation and need of steroids at follow up. In the follow up of the ”Step-up and Top-down” trial, complete mucosal healing after 2 years of therapy predicted sustained, steroid-free remission through out the 2 years follow up, independently of initial treatment. Preliminary data from the GETAID study, suggest that approximately 40% of patients in remission for at least 6 months on combination therapy with immunomodulator and infl iximab, relapse within 1 year after stopping infl iximab. However, patients in ”deep remission”, i.e. clinical remission in combination with endoscopic remission and normal f-Calprotectin had a much lower risk of relapse.Conclusion: Studies analyzing if early introduction of biologics can decrease bowel damage and change the disease course are warranted. The question when biologics can be stopped or interrupted with sustained remission is of utmostimportance and needs to be addressed.
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| 7. |
- Stjernman, Henrik
(author)
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Crohn’s Disease in Sickness and in Health : Studies of Health Assessment Strategies and Impact on Health-Related Quality of Life
- 2011
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Doctoral thesis (other academic/artistic)abstract
- Background and aims. Crohn’s disease (CD) is a chronic inflammatory bowel disease (IBD) with potentially deleterious effects on well-being and daily-life functioning. A complete picture of health status in CD therefore comprises both disease activity (DA) and health-related quality of life (HRQL). Several measures of DA and HRQL in CD have been developed. Some have gained prominence as standard endpoints in clinical trials, but none has been validated in Swedish CD patients and their use in clinical practice has been limited. A conceptual health status model of five dimensions (Biological variables, Symptoms, Function, Worries, and Well-being) has been proposed for IBD health assessment, enabling the construction of the Short Health Scale (SHS), a four-item questionnaire intended to facilitate assessment and interpretation of HRQL in IBD.The aims of this thesis were: (1) to evaluate the Swedish versions of the Inflammatory Bowel Disease Questionnaire (IBDQ) and the Rating Form of IBD Patient Concerns (RFIPC); (2) to evaluate the Short Health Scale; (3) to study the relationship between DA and HRQL variables by identifying determinants of DA outcome and by validating the SHS health status model; (4) to describe the spectrum of disease-related worries and repercussions on general HRQL in a context of social variables, sickness, and disability.Methods. The thesis is based on clinical variables and HRQL data measured in a population-based cohort of 505 CD patients, consecutively included in conjunction with their regular outpatient visits at three hospitals (Jönköping, Örebro, Linköping). The HRQL questionnaires were evaluated regarding construct validity, reliability, and responsiveness. Multivariate analyses were used to investigate the relationship between Crohn’s Disease Activity Index (CDAI) and physician-assessed DA. The SHS health status model was validated with structural equation modelling (SEM). Disease-related worries and concerns, general HRQL, social variables, sickness, and work disability were compared with data from background population or patients with ulcerative colitis (UC).Results. The IBDQ had good validity, reliability, and responsiveness, but the original dimensional structure was not supported. The RFIPC was valid, and reliable, but less sensitive to change in disease activity. The SHS had the highest completion rate and proved adequate psychometric properties. The CDAI correlated weakly with the physician’s appraisal of disease activity, being more influenced by subjective health perception than objective disease activity. SEM showed that the SHS model had a good fit to measured data, explaining >98% of the covariance of the variables. Worries and general HRQL impairment were greater in CD than in UC, especially for women. Disease complications and impaired life achievements elicited most worries. CD patients had lower educational level. Female patients were more often living single. The rates of long-term sickness and disability were doubled compared with background population, with worse outcome for women.Conclusions. The IBDQ, the RFIPC, and the SHS all demonstrated adequate psychometric properties. The SHS was easier to administer and provided a more comprehensive picture of subjective health status. The weak correlation between CDAI and physician-assessed DA was explained by a strong influence of subjective variables on CDAI, stressing the importance of assessing DA and HRQL separately. The SHS health status model was further supported by SEM. CD has tangible effects on subjective health perception, worries and work capacity, especially for women.
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