Subteam 2 Patient involvement in the design implementation

Sub-team 2: Patient involvement in the design, implementation and evaluation of additional risk minimization measures Stella Blackburn, Mary O’Hare, Leo Russo, Panos Tsintis, Judy Zander, Stephen Heaton

Scope • Describe how patients can directly and indirectly provide input for the design of risk minimisation tools, and • Describe how modification of risk through use of risk minimisation tools can change patient perspective and/or preference in benefit risk acceptability

Thethe risks The Benefit Risk Balance

Key words • • Benefit risk acceptability Burden Patient perspective Patient preference Risk minimisation

Initial Thoughts from 1 st Meeting • • • How can patient participation enable which risks to mitigate/minimize? What are the attributes that matter to patients? Risk tolerance? What side effects are important to patients? How can prioritizing of risks (severity vs seriousness) be impacted by patient input? What is the impact or burden of RMin* on patients’ drug use? Does it affect adherence? What are methodologies can be considered? – Human factor analysis, used to identify root cause – Failure mode analysis, where do patients anticipate problems? – Patient preference and perspective as applied to different RMin tools especially in view of benefit risk accepatability – Readability of information materials – User testing – Defining the proper population