• Study designs needed to address the questions raised by this PIVI
• Training: The benefit of using simulators for training can only be validated in an adequately powered, controlled trial that demonstrates that the incorporation of simulators in a training program leads to acquisition of technical and cognitive competency with fewer clinical endoscopic procedures than required by traditional supervised endoscopic instruction without access to the simulator.
• Assessment: A simulator that is able to assess the actual clinical skills (technical and cognitive) of a clinician performing endoscopy may be a useful tool for credentialing (or recredentialing). A prerequisite for any validation of such a tool would be a previous consensus on how to measure competency for a particular procedure in real patients.
• Suggested areas for future development
• The road to reaching the target for simulator-based skills assessments will require both improvement in the way in which actual clinical procedure performance is assessed and advances in the simulators themselves. Specifically, this will require the following:
• Development of accurate, reliable, and validated clinical patient-based assessment tools for all endoscopic procedures to establish learning curves and benchmark clinical performance abilities.
• Development of simulated cases of increased difficulty to allow discrimination of differing grades of ability (not just novice/expert).
• Development of clinically relevant, accurate, and reliable simulator assessment metrics that effectively distinguish the different grades of ability and correlate with clinical performance benchmarks in prospective validation studies.
As professional societies work to better define the constituents and benchmarks for competency in various procedures, investigators and providers of simulators will need to focus their efforts on addressing current unmet needs, determining which trainees get the most benefit from which tools, and reducing the cost of simulation to improve access and use.
The PIVI committee (consisting of a committee of ASGE physician experts) in preparing the document, employed evidence-based methodology, using a MEDLINE and PubMed literature search to identify pertinent clinical studies on the topic. The PIVI is provided solely for educational and informational purposes and to support incorporating these endoscopic technologies into clinical practice. It should not be construed as establishing a legal standard of care. To read the full PIVI document, log on to ASGE’s website at www.asge.org.