Análisis
Published on 6 de marzo de 2025 | http://doi.org/10.5867/medwave.2025.02.3044
Innovation and bioethics in surgery: Redefining boundaries for a safe and human-centered future
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IDEAL framework stages: Purposes and research methods.
| Pre-IDEAL | Feasibility and definition of the new procedure | Various: simulator, cadaver, animals, modeling, cost-effectiveness studies |
| 1: Idea | Concept testing | Structured case reports |
| 2a: Development | Procedure development | Prospective development studies |
| 2b: Exploration | Consensus reached among surgeons and centers | Multicenter exploratory cohort study (based on disease or treatment) |
| 3: Assessment or Evaluation | Comparative effectiveness testing | RCT with or without additions/modifications; alternative designs (cluster, preference RCTs, stepped wedge, adaptive designs) |
| 4: Long-term Monitoring | Surveillance | Registry, routine database, rare case reporting |
RCT: Randomized Controlled Trial.
Source: Translated from the IDEAL Collaboration website: https://www.ideal-collaboration.net/wp-content/uploads/2021/04/IDEAL-Update-Table2_AnnalsSurg2019.pdf.