Table 3.
Defining characteristics of phases of surgical and interventional innovations (adapted from http://www.ideal-collaboration.net/about-ideal/ideal-summary-tables/)
1. Idea | 2a. Development | 2b. Exploration | 3. Assessment | 4. Long-term monitoring | |
---|---|---|---|---|---|
Purpose | Proof of concept | Development | Learning | Assessment | Surveillance |
Number and types of patients | Single digit; highly selected | Few; selected | Many; may expand indications | Many; expanded indications | All eligible |
Number and types of surgeons | Very few | Few; innovators and some early adopters | Many; innovators, early adopters, early majority | Many; early majority | All eligible |
Study types | Structured case reports | Prospective development studies | Research databases; feasibility RCT | Surgical randomised controlled studies | Prospective registries |