IDEAL Stage 2b is Exploration.
What is the primary goal of this stage?
The goal of the exploration stage is to build upon the technique established in the development stage (thus the delineation of 2a and 2b for development and exploration, respectively) expand the patient base to the 100s.
What are the secondary goals of this stage?
Researchers should start capturing data systematically, if they have not being doing so already.
How should procedures in the Exploration stage be reported?
All studies should be prospective and, where possible, controlled. One way to look at this stage is as a precursor to the randomised controlled trial. Study designs may include: prospective uncontrolled studies, feasibility RCTs, and explanatory RCTs. Prospective collaborative studies should work towards a cooperative RCT (a.k.a. Phase IIS study) in the next stage, Assessment.
What are some examples of procedures in this stage?
- Single-incision laparoscopy for cholecystectomy
- Single-incision laparoscopy for appendectomy
- Percutaneous mitral valve repair