OPtical Diagnosis Training to Improve Dysplasia Characterisation in IBD
Condition: Inflammatory Bowel Diseases; Dysplasia Colon; Dysplasia, Crohn Disease-Associated; Polyp of Colon; Ulcerative Colitis; Crohn Colitis; Crohn Disease
MeSH terms: Crohn Disease; Colitis; Intestinal Diseases; Inflammatory Bowel Diseases; Hyperplasia; Colonic Polyps
Study type: Interventional

Summary: 
      People with inflammatory bowel diseases (IBD) can be at higher risk of developing abnormal
      areas in their bowel. These abnormal areas can be due to active inflammation, healed
      inflammation, polyps or pre-cancerous changes ("dysplasia"). It is for this reason that
      people with IBD are offered periodic surveillance colonoscopy procedures to identify,
      characterize and where necessary remove abnormal areas or lesions from the bowel. These can
      be difficult to characterize correctly, which is important to make the correct endoscopic
      diagnosis and management plan. Technical advancements in endoscopy mean that more tools are
      available to identify and characterize these lesions in real time during colonoscopy.
      Specialists regularly performing gastrointestinal endoscopy and colonoscopy ("endoscopists")
      will often receive special training, both during their initial postgraduate training and
      through continuous professional development programs.

      This study aims to evaluate whether an online training platform can improve the ability of
      endoscopists to characterize dysplasia in IBD. The goal is to support improved
      decision-making during IBD surveillance, reporting of dysplastic lesions, and ultimately the
      care and outcomes of people with IBD.
    

Detailed description: 
      This study aims to evaluate whether an online training platform can improve the ability of
      endoscopists to characterise dysplasia in inflammatory bowel disease (IBD), to ultimately
      improve decision-making, reporting of dysplastic lesions and management during IBD
      surveillance.

      Colonoscopy (endoscopic examination of the lower bowel) is a well-established screening tool
      to identify lesions within the bowel and objectively assess the degree of inflammation
      present. Patients with IBD, both Ulcerative colitis (UC) and Crohn's disease (CD), have a
      higher risk of developing cancers of the bowel and it is for this reason that they undergo
      regular surveillance procedures. Guidelines recommend surveillance procedures using high
      definition white light endoscopy alongside either Dye-Based Chromoendoscopy (DCE) or Virtual
      Chromoendoscopy (VCE), with targeted biopsies. However, the real world adoption of DCE and
      VCE is still modest. Due to technological advances there are alternative endoscopic imaging
      techniques that selectively enhance certain mucosal and vascular features, including
      narrow-band imaging (NBI), i-Scan optical enhancement (i-Scan-OE) and blue laser imaging
      (BLI).

      These technologies have been demonstrated to be more effective than standard white light
      endoscopy. Despite these advances in technology, detecting dysplasia within areas of
      inflammation due to IBD is challenging. An endoscopic classification was recently developed
      by Iacucci M et al called "FACILE" to characterise in detail the mucosal and vascular pattern
      to predict histological colonic lesions in IBD. Since traditional lesion assessment systems
      such as (unmodified) Kudo pit pattern are less reliable in IBD, there is a need for a robust
      scoring system to assist clinicians in detecting and characterising lesions in IBD.

      This project is to validate a training module on surveillance and colonic lesion
      characterisation in IBD. We aim to compare polyp detection in IBD surveillance procedures
      before and after training and evaluate the impact. As a sub-study, an additional
      randomisation process will take place whereby one group will receive additional focused
      top-up training and the other group will not. We will seek to compare the impact of feedback
      on knowledge retention.

      Study stages:

        -  Stage 1. Potential participants are provided an electronic PIS outlining the study.

        -  Stage 2. Participants consent to the study and complete the pre-training assessment on
           REDCap (1 hour).

        -  Stage 3. Participants are provided with login details for online training.

        -  Stage 4. Participants complete the online training in their own time (1 hour).

        -  Stage 5. Participants complete the same assessment (as pre-training) and are given 1-2
           weeks to complete this after training.

        -  Sub-study: Participants are randomised 1:1 to either receive or not receive a short
           refresher training module (15 min).

        -  Stage 6. After 8-12 weeks post-training participants are invited to complete the same
           assessment process (as pre-training).

      All participants will receive computer-based training. Training will take place via an online
      computer- based self-learning platform. The training will include reviewing short videos of
      colorectal polyps in patients with IBD and videos of inflammation in IBD (quiescent, mild,
      moderate and severe) using NBI, i-Scan-OE and BLI. Patients were consented for the use of the
      use of videos for educational purposes. Videos used have been fully anonymised.

      All Participants are given access to the secure REDCap platform hosted at the University of
      Birmingham. Participants will be required to register using a general survey to include their
      email address, anonymised demographic data, procedural experience and familiarity with
      optical endoscopic diagnosis platforms.

      Participants comprise three categories: novice, training endoscopist and experienced
      endoscopist. The latter two are the key categories for evaluation.

        -  Novice will include medical students and junior doctors/residents who have previously
           had no or little endoscopic experience.

        -  Training endoscopists will be gastroenterology and general surgery
           trainees/residents/fellows.

        -  Experienced endoscopists will be fully qualified endoscopists such as GI and general
           surgery staff, consultants and nurse endoscopists.

      Participants will then complete pre-training assessment prior to e-learning training. There
      are 26 video clips representative of different types of colonic lesions in IBD. Each video
      clip is typically 20-30 seconds. The overall duration of the assessment is around one hour.

      Participants will then be given a login for the online training material and will complete
      this in their own time. Participants will be taught on endoscopic surveillance in IBD and how
      to characterise polyps accurately. The duration of the training module is 1 hour. It is
      interactive with optional components for tailored self-directed learning.

      A post-training assessment will be completed in the next 1-2 weeks, using the same video
      clips, allowing us to compare the performance of participants before and after training. The
      assessment will be repeated after 8-12 weeks to assess the retention of skills.

      An additional randomisation process on a 1:1 basis will take place, whereby one group will
      receive additional short refresher training following their responses to assessment questions
      and the other group will not. We will seek to compare the impact of feedback on
      sustainability of knowledge retention.
    

Intervention name(s): Online self-learning training module; Refresher training
Intervention type(s): Other; Other
Intervention description(s): Training module in optical diagnosis of IBD-associated dysplastic lesions during gastrointestinal endoscopy; Brief refresher training in optical diagnosis of IBD-associated dysplastic lesions during gastrointestinal endoscopy
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: All enrolled participants are allocated to the same intervention, with pre-course and post-course assessments.
Participants will then be randomized 1:1 to one of two arms: (1) to receive short refresher training on optical diagnosis, or (2) no additional intervention.
All participants will complete a final late post-course assessment to test knowledge retention from the training module and the impact of refresher training.
Masking: None (Open Label)
Primary purpose: Other
Keywords: Endoscopy; Optical diagnosis; Dysplasia surveillance; Inflammatory bowel disease