Including the patient’s voice in measuring risks and benefits was the topic of the plenary presentation by Dr. Ware and others at the 29th International Conference on Pharmacoepidemiology and Therapeutic Risk Management, Montreal Convention Center, Montreal, Canada on August 25th, 2013. The goal of the presentations was to present new initiatives to better understand the patient’s voice regarding the safety and effectiveness of pharmaceutical products in real world use. Dr. Ware opened the session with a presentation entitled “Improving Disease-specific and Generic Patient-reported Outcome (PRO) Measures to Better Capture the Beneficial and Adverse Effects of Pharmaceutical Therapies” in which a comprehensive endpoint model was applied to both validating PROs and evaluating treatment PRO benefits. Included was an example of the construct (convergent-discriminant) validation of the Quality of Life Disease Impact Scale (QDIS®), a new approach to standardizing both the content and scoring of the QOL impact attributed to specific conditions. More information can be found here.