This session will highlight the importance of interpretation of the benefits versus the risks of harm when assessing responsiveness to a therapeutic agent and how different stakeholder groups interpret these results. Discussions will include calculations of number needed to treat for benefit and number needed to treat for placing patients at risk of harm. They will also address how patient-reported outcomes may impact these data and what this can tell stakeholders about the usefulness of a therapy. This session is hosted by Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT).

Learning Objectives:
Describe how best to calculate number needed to treat versus at risk of harm
Examine the benefits and potential risks of analyses, and how various stakeholder groups may interpret results
Demonstrate the utility of patient-reported outcomes in expression of potential benefits and harms of therapies.