IBDIS.Interobserver agreement synopsis
| Introduction | IBDIS is a web-based documentation standard for patients with inflammatory bowel diseases. The potential applicability of IBDIS is manifold and designed to support several potential applications. From a ready-to-use tool for scientific analysis to an electronic patient record with integration into the clinical routine, or an electronic case report form, as applied in clinical trials, registries, biobanks or health economic studies. |
| Aims | The study is designed to validate each of the disease relevant parameters captured by IBDIS by a pan-European interobserver study. |
| Documentation and Data | ECCO members from 14 European countries provided patient files which are made available as PDF-files in the members area of the IBDIS homepage (documentation.ibdis.net). 20 observers, at best 10 members of Young ECCO (YECCO) and 10 national representatives will be asked to capture the data from the provided patient files by means of web-based IBDIS. To investigate intraobserver agreement (retest reliability) one third (n =7) of the observers reevaluate 7 medical records after another 12 weeks. Both observers and charts will be selected randomly. |
| Statistics | Interobserver agreement (IOA) analysis is an accuracy analysis that calculates the percentage (standard deviation, SD, or the 95% confidence interval, CI) of observer agreement with a predetermined reference observer. The agreement between the mode (the most frequently assessed value) and the reference observer is expressed as a percentage. Statistical characterization of the strength of interobserver agreement will be determined using Cohens kappa (k). In the study each patient file will be considered as an independent observation. The intra-observer agreement analysis (retest reliability) is an accuracy analysis calculating the percentage of agreement between first and second observation of the 7 selected observers. |
| Organisational issues | The IBDIS staff will support each observer. The applicants of this project proposal and all observers who agree to perform the second evaluation as part of the intra-observer agreement analysis will co-author the manuscript. Each observer and each provider of a patient file will be named in the acknowledgement of the publication. Manuscripts deriving from the study will name ECCO as sponsor and ought to be submitted to the Journal of Crohns and Colitis (JCC) as original contribution. |
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