Evidence Challenges
- Availability of evidence
- Needs for evidence are increasing
- Large gaps in the existing literature
- Limited generalizability of trials data to real-world practice
- Unique challenges of devices
- Distinguishing operator vs. product effects
- Short product life-cycles
- Feasibility of RCTs
- Conclusions from the evidence
- Reconciling "average" population effects with individual effects
- "Shelf-life" of evidence
- Practical use of evidence
- Application of evidence to real-world medical decisions
- Provider "accountability" for using evidence
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