FIGURE 2-1 The translational process.

SOURCE: Teutsch, 2009.

in developing guidelines, Teutsch said, is how high the evidence bar should be. By employing a lower threshold, technologies can move more rapidly from research into practice. The consequences are that less information is available on the clinical validity of the technology, and almost no information is available about the clinical use. This lack of information can lead to negative insurance coverage decisions. There is the potential for increased harms because less is known about the technology, but also the potential for increased benefits by providing the technology sooner to those who may need it. Requiring a lower evidentiary bar means a greater dependence on models and expert opinion. Because technologies can enter practice more easily, a lower bar might stimulate innovation, thereby making more technologies available.

If the evidentiary bar is high, more will be known about the validity and utility of the technology, and payers can make better decisions about reimbursement. On the other hand, a higher threshold for evidence makes moving technologies into practice more difficult, which can potentially lower the incentive for innovation. More is known about the technology, resulting in a diminished potential for harms, but it will take a longer time to bring the product to those who can benefit from it.

When making an evidence-based decision, several questions must be answered:

• What decision must be made?

• How does the nature of that decision affect the evidentiary standards that should be applied?

• What are the relevant contextual issues?