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

Johan Burisch; Javier P Gisbert; Britta Siegmund; Dominik Bettenworth; Sandra Bohn Thomsen; Isabelle Cleynen; Anneline Cremer; Nik John Sheng Ding; Federica Furfaro; Michail Galanopoulos; Philip Christian Grunert; Jurij Hanzel; Tamara Knezevic Ivanovski; Eduards Krustins; Nurulamin Noor; Neil O'Morain; Iago Rodríguez-Lago; Michael Scharl; Julia Tua; Mathieu Uzzan; Nuha Ali Yassin; Filip Baert; Ebbe Langholz

doi:10.1093/ecco-jcc/jjy015

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

Johan Burisch, Javier P Gisbert, Britta Siegmund, Dominik Bettenworth, Sandra Bohn Thomsen, Isabelle Cleynen, Anneline Cremer, Nik John Sheng Ding, Federica Furfaro, Michail Galanopoulos, Philip Christian Grunert, Jurij Hanzel, Tamara Knezevic Ivanovski, Eduards Krustins, Nurulamin Noor, Neil O'Morain, Iago Rodríguez-Lago, Michael Scharl, Julia Tua, Mathieu UzzanNuha Ali Yassin, Filip Baert, Ebbe Langholz

Institut for Klinisk Medicin

4 Citationer (Scopus)

Abstract

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.

Originalsprog	Engelsk
Tidsskrift	Journal of Crohn's and Colitis
Vol/bind	12
Udgave nummer	5
Sider (fra-til)	532-537
ISSN	1873-9946
DOI	https://doi.org/10.1093/ecco-jcc/jjy015
Status	Udgivet - 27 apr. 2018

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10.1093/ecco-jcc/jjy015

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Burisch, J., Gisbert, J. P., Siegmund, B., Bettenworth, D., Thomsen, S. B., Cleynen, I., Cremer, A., Ding, N. J. S., Furfaro, F., Galanopoulos, M., Grunert, P. C., Hanzel, J., Ivanovski, T. K., Krustins, E., Noor, N., O'Morain, N., Rodríguez-Lago, I., Scharl, M., Tua, J., ... Langholz, E. (2018). 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. Journal of Crohn's and Colitis, 12(5), 532-537. https://doi.org/10.1093/ecco-jcc/jjy015

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 et al.

I: Journal of Crohn's and Colitis, Bind 12, Nr. 5, 27.04.2018, s. 532-537.

Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › peer review

Burisch, J, Gisbert, JP, Siegmund, B, Bettenworth, D, Thomsen, SB, Cleynen, I, Cremer, A, Ding, NJS, Furfaro, F, Galanopoulos, M, Grunert, PC, Hanzel, J, Ivanovski, TK, Krustins, E, Noor, N, O'Morain, N, Rodríguez-Lago, I, Scharl, M, Tua, J, Uzzan, M, Ali Yassin, N, Baert, F & Langholz, E 2018, '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', Journal of Crohn's and Colitis, bind 12, nr. 5, s. 532-537. https://doi.org/10.1093/ecco-jcc/jjy015

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title = "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",

abstract = "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.",

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author = "Johan Burisch and Gisbert, {Javier P} and Britta Siegmund and Dominik Bettenworth and Thomsen, {Sandra Bohn} and Isabelle Cleynen and Anneline Cremer and Ding, {Nik John Sheng} and Federica Furfaro and Michail Galanopoulos and Grunert, {Philip Christian} and Jurij Hanzel and Ivanovski, {Tamara Knezevic} and Eduards Krustins and Nurulamin Noor and Neil O'Morain and Iago Rodr{\'i}guez-Lago and Michael Scharl and Julia Tua and Mathieu Uzzan and {Ali Yassin}, Nuha and Filip Baert and Ebbe Langholz",

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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 - 2018/4/27

Y1 - 2018/4/27

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

SN - 1873-9946

VL - 12

SP - 532

EP - 537

JO - Journal of Crohn's and Colitis

JF - Journal of Crohn's and Colitis

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ER -

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

Abstract

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