Validation of the 'United Registries for Clinical Assessment and Research' (UR-CARE), a European online registry for clinical care and research in Inflammatory Bowel Disease
| Autor: | Ebbe Langholz, Julia Tua, Philip Grunert, Nik S. Ding, Nuha A. Yassin, Mathieu Uzzan, Javier P. Gisbert, Johan Burisch, Iago Rodríguez-Lago, Federica Furfaro, Sandra Bohn Thomsen, Nurulamin M Noor, A Cremer, Tamara Knezevic Ivanovski, Filip Baert, Eduards Krustins, Isabelle Cleynen, Britta Siegmund, Jurij Hanzel, Michael Scharl, Michail Galanopoulos, Neil O'Morain, Dominik Bettenworth |
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| Přispěvatelé: | University of Zurich, Burisch, Johan |
| Jazyk: | angličtina |
| Rok vydání: | 2018 |
| Předmět: |
Adult
Male Pediatrics medicine.medical_specialty Biomedical Research MEDLINE 610 Medicine & health Inflammatory bowel disease 03 medical and health sciences 0302 clinical medicine McNemar's test medicine Humans 2715 Gastroenterology Registries 030212 general & internal medicine Observer Variation Internet Crohn's disease business.industry Gastroenterology Reproducibility of Results General Medicine Inflammatory Bowel Diseases medicine.disease Ulcerative colitis Confidence interval digestive system diseases Data Accuracy Europe 10219 Clinic for Gastroenterology and Hepatology Clinical research Cohort Female 030211 gastroenterology & hepatology business |
| Popis: | Background The 'United Registries for Clinical Assessment and Research' [UR-CARE] database is an initiative of the European Crohn's and Colitis Organisation [ECCO] to facilitate daily patient care and research studies in inflammatory bowel disease [IBD]. Herein, we sought to validate the database by using fictional case histories of patients with IBD that were to be entered by observers of varying experience in IBD. Methods Nineteen observers entered five patient case histories into the database. After 6 weeks, all observers entered the same case histories again. For each case history, 20 key variables were selected to calculate the accuracy for each observer. We assumed that the database was such that ≥ 90% of the entered data would be correct. The overall proportion of correctly entered data was calculated using a beta-binomial regression model to account for inter-observer variation and compared to the expected level of validity. Re-test reliability was assessed using McNemar's test. Results For all case histories, the overall proportion of correctly entered items and their confidence intervals included the target of 90% (Case 1: 92% [88-94%]; Case 2: 87% [83-91%]; Case 3: 93% [90-95%]; Case 4: 97% [94-99%]; Case 5: 91% [87-93%]). These numbers did not differ significantly from those found 6 weeks later [NcNemar's test p > 0.05]. Conclusion The UR-CARE database appears to be feasible, valid and reliable as a tool and easy to use regardless of prior user experience and level of clinical IBD experience. UR-CARE has the potential to enhance future European collaborations regarding clinical research in IBD. |
| Databáze: | OpenAIRE |
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