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
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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. / Burisch, Johan; Gisbert, Javier P; Siegmund, Britta; Bettenworth, Dominik; Thomsen, Sandra Bohn; Cleynen, Isabelle; Cremer, Anneline; Ding, Nik John Sheng; Furfaro, Federica; Galanopoulos, Michail; Grunert, Philip Christian; Hanzel, Jurij; Ivanovski, Tamara Knezevic; Krustins, Eduards; Noor, Nurulamin; O'Morain, Neil; Rodríguez-Lago, Iago; Scharl, Michael; Tua, Julia; Uzzan, Mathieu; Ali Yassin, Nuha; Baert, Filip; Langholz, Ebbe.
In: Journal of Crohn's and Colitis, Vol. 12, No. 5, 2018, p. 532-537.Research output: Contribution to journal › Journal article › Research › peer-review
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TY - JOUR
T1 - 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
AU - Burisch, Johan
AU - Gisbert, Javier P
AU - Siegmund, Britta
AU - Bettenworth, Dominik
AU - Thomsen, Sandra Bohn
AU - Cleynen, Isabelle
AU - Cremer, Anneline
AU - Ding, Nik John Sheng
AU - Furfaro, Federica
AU - Galanopoulos, Michail
AU - Grunert, Philip Christian
AU - Hanzel, Jurij
AU - Ivanovski, Tamara Knezevic
AU - Krustins, Eduards
AU - Noor, Nurulamin
AU - O'Morain, Neil
AU - Rodríguez-Lago, Iago
AU - Scharl, Michael
AU - Tua, Julia
AU - Uzzan, Mathieu
AU - Ali Yassin, Nuha
AU - Baert, Filip
AU - Langholz, Ebbe
PY - 2018
Y1 - 2018
N2 - 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.
AB - 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.
KW - Adult
KW - Biomedical Research
KW - Data Accuracy
KW - Europe
KW - Female
KW - Humans
KW - Inflammatory Bowel Diseases/therapy
KW - Internet
KW - Male
KW - Observer Variation
KW - Registries/standards
KW - Reproducibility of Results
U2 - 10.1093/ecco-jcc/jjy015
DO - 10.1093/ecco-jcc/jjy015
M3 - Journal article
C2 - 29415255
VL - 12
SP - 532
EP - 537
JO - Journal of Crohn's and Colitis
JF - Journal of Crohn's and Colitis
SN - 1873-9946
IS - 5
ER -
ID: 215369375