Patient Preference Information (PPI) is one type of patient feedback that provides assessments of the desirability or acceptability of different treatment alternatives. This information shows the value attributed to different aspects of each alternative and it can be used to add a patient perspective to the treatment’s risk/benefit assessment. CDRH uses patient preference information on medical devices to:
- Identify the most important benefits and risks of a technology from a patient’s perspective;
- Assess the importance of clinical study outcomes to patients;
- Determine a meaningful change in study outcomes;
- Clarify how patients think about the tradeoffs of these benefits and risks for a given technology; and
- Show how patient preferences vary across a population, regarding benefits and risks of various treatment options.
The division provides guidance and other information on the use of PPI at the Patient Preference Information website. There has been considerable activity to define the areas for which patient preference information (called patient preference-sensitive areas) would be valuable in a regulatory sense. In early May 2019, the agency requested public feedback on these patient preference-sensitive areas. A web page listing the areas is also available. I can see how many of these areas would affect the patient experience and lead them to choose one device over another without considering the potential outcome, risks, and benefits. I believe the conversation would be aided by studies showing the impact of various preferences on treatment compliance, safety or efficacy.
Text Copyright © 2019 Katrina Rogers