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Endoscopic scoring systems are vital for the objective assessment of disease activity being used in both clinical trials and daily clinical practice. These standardized scoring systems are essential for diagnosing, evaluating endoscopic healing, monitoring treatment response, and predicting clinical outcomes.
One of the primary challenges in implementing these scoring systems is inter-observer variability, as highlighted by significant discrepancies between scores assigned by local and central reviewers. However, the performance of these systems among experts has been shown to be excellent, suggesting that achieving consistent and accurate scoring requires a high level of exposure and proficiency.
Inconsistent scoring, especially among less experienced clinicians, poses a challenge to the reliability of these scoring systems.
The primary objective of this study is to evaluate the improvement of scoring accuracy after training with structured educational videos with a specific focus on the learning curve and the practical application of endoscopic scoring systems.
Endoscopy is a cornerstone in diagnosis, management and monitoring of patients with inflammatory bowel disease (IBD), comprising Crohn's disease (CD) and ulcerative colitis (UC). Endoscopy in combination with histological assessment plays a crucial role in diagnosis of IBD, distinguishing between UC and CD and ruling out other diseases with similar clinical presentations. The STRIDE-II consensus, developed by the International Organization for the Study of IBD (IOIBD), highlights endoscopic healing as the primary long-term therapeutic goal. Achieving endoscopic healing is associated with improved patient outcomes, including steroid-free remission, a reduced risk of clinical relapse, hospitalization, colectomy, and dysplasia or colorectal cancer.
Endoscopic scoring systems are vital for the objective assessment of disease activity being used in both clinical trials and daily clinical practice. These standardized scoring systems are essential for diagnosing, evaluating endoscopic healing, monitoring treatment response, and predicting clinical outcomes.
The most widely adapted scoring systems in IBD include:
One of the primary challenges in implementing these scoring systems is inter-observer variability, as highlighted by significant discrepancies between scores assigned by local and central reviewers. However, the performance of these systems among experts has been shown to be excellent, suggesting that achieving consistent and accurate scoring requires a high level of exposure and proficiency.
Inconsistent scoring, especially among less experienced clinicians, poses a challenge to the reliability of these scoring systems. Daperno et al. demonstrated in their study that a structured educational training program significantly enhanced inter-observer agreement. The study, including 237 gastroenterologists with at least three years of post-certification experience, showed substantial improvements in scoring consistency across multiple IBD scoring systems (SES-CD, Mayo Endoscopic Subscore, and Rutgeerts Score) following the training. These findings emphasize the importance of comprehensive training to ensure reliable and consistent endoscopic evaluations. Intensive education programs are crucial for improving scoring accuracy, enabling effective disease monitoring and management in IBD.
New scoring systems for assessing disease activity are developing, however, they are relatively unknown among gastroenterologists and are not yet widely used in clinical practice.
In the CONCORDIA study, the investigators will evaluate gastroenterology fellows' familiarity with these new scoring systems and assess whether structured endoscopic video assisted training improves scoring accuracy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A (Early training) | Active Comparator | Following the first video assessment only participants in Group A will attend the structured training module. During Time Period 2 (approximately one month), all participants will score the same 15 + 15 videos. However, only participant in Group A will have access to the explanatory videos used in the online training module. |
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| Group B (Late training) | No Intervention | After the second video assessment participants in Group B will receive the structured training module. During Time Period 3 (approximately one month), participants in Group B will score the 15 + 15 videos again while having access to the explanatory videos used in the online training module. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Training | Other | A structured teaching module for fellows in training will be prepared and conducted at three university centres, namely University Hospitals Leuven, Ljubljana University Medical Centre, and CHU de Bordeaux. The training module will include short endoscopic videos (different from the pre- and post-training set), which participants will score in real-time using a polling application. This will be followed by a step-by-step demonstration of each scoring principle with explanations of the reasoning behind specific scores. Each scoring system will be reviewed in a short training video that provides a structured demonstration, highlights common pitfalls, and showcases typical IBD-associated endoscopic features. After the video training, participants will have the opportunity to ask questions to the experts. |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement of Updated Rutgeerts scoring accuracy after training with structured educational videos | In substudy A, the investigators will focus on the updated Rutgeerts score for patients with Crohn's disease that previously underwent an ileocolonic resection with ileocolonic anastomosis. | 3 months |
| Improvement of ePDAI scoring accuracy after training with structured educational videos | In substudy B, the investigators will focus on the Endoscopic element of the Pouchitis Disease Activity Index (ePDAI) for patients with ulcerative colitis that previously underwent a proctocolectomy with ileal pouch-anal anastomosis (IPAA). ePDAI consists of six features describing mucosal changes: oedema, granularity, friability, loss of vascular pattern, mucous exudate and ulceration. | 3 months |
| IImprovement of SES-pouchitis scoring accuracy after training with structured educational videos | In substudy B, the investigators will focus on the Simple Endoscopic Score (SES)-pouchitis for patients with ulcerative colitis that previously underwent a proctocolectomy with ileal pouch-anal anastomosis (IPAA). SES-pouchitis evaluates four key parameters, ulcer size, ulcerated surface, affected surface area, and luminal narrowing, in the ileal pouch. | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marc Ferrante | Contact | +3216344225 | +32 | marc.ferrante@uzleuven.be |
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The primary objective of this study is to set-up a training for gastroenterology fellows
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| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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The CONCORDIA study will be conducted in three sequential time periods. During Time Period 1 (two months), all participants will independently score 15 endoscopic videos using the updated Rutgeerts score and 15 videos with ePDAI and SES-pouch, supplemented with a general Visual Analogue Scale (VAS) score (0=no inflammation, 10=most severe inflammation). No specific guidance will be provided during that phase.
Following the first video assessment only participants in Group A will attend the structured training module.
During Time Period 2 (one month), all participants will score the same 15 + 15 videos. However, only participant in Group A will have access to the explanatory videos used in the online training module.
After the second video assessment participants in Group B will receive the structured training module.
During Time Period 3 (one months), participants in Group B will score the 15 + 15 videos again while having access to the explanatory videos used in the online training.
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