Table 2.
The IDEAL framework.
Adapted from Lee [39]
| IDEAL stage | Stage 1 (idea) | Stage 2a (development) | Stage 2b (exploration) | Stage 3 (assessment) | Stage 4 (long term study) |
|---|---|---|---|---|---|
| Number of surgeons | Very few | Few | Many | Many | All eligible |
| Number of patients | Single to few | 10s | 100s | 100s + | 100s + |
| Ethical oversight | Informed consent only | Register protocols, local ethical approvals | Standard research ethics approvals | Standard research ethics approvals | Informed consent only |
| Outcome measurement | Case reports | Prospective development studies | Feasibility randomised control trial | Randomised control trial or alternative designs | Registry, audit |