Table 2

Summary of suggested changes and improvements in the conduct of clinical trial endoscopy

Suggested improvement or change (in order of presentation in the paper)ImportanceEase of implementation
Colonoscopy only for UC trials.++++
Require split dosing for colonoscopy preps.++++++
Avoid early morning colonoscopy for trial participants.++++
Standardise bowel prep to polyethylene glycol 3350.++++++
Require vendors to present videos to central readers at the same resolution as recorded (no downsampling).++++++
Capture metrics for colonoscopy acquisition times (site reader) and viewing times (central reader) and set minimum standards.++++
Involve site endoscopists as readers.+++
Central reading training programmes by GI societies.++++
Better training and collaborative use of ancillary personnel.++++
Design new scoring systems (endoscopic outcome instruments), especially for UC, that better reflect inflammatory burden and are validated for their context of use, possibly using machine learning.+++++
Harmonise central reader qualification processes with clinical credentialing requirements.++++
Insist on more transparency regarding vendor central reader training programmes and harmonisation (see also above ‘Central reading training programmes by GI societies’).+++++
Embrace ML to inform development of new scoring systems.++++
Read algorithms (aggregation of the input of more than one reader per video into the final score): choose statistical over non-statistical data aggregation methods.+++++++
Create prespecified thresholds for acceptable versus unacceptable bowel preps, possible implementation with ML algorithms prior to presentation to central readers.+++++
  • GI, gastrointestinal; ML, machine learning; UC, ulcerative colitis.