Last week, Modus Outcomes’ own Stefan Cano (https://modusoutcomes.com/stefan-cano/), together with Professors Anne Klassen (McMaster University; https://fhs.mcmaster.ca/ceb/faculty_member_klassen.htm) and Andrea Pusic (Memorial Sloan Kettering Cancer Center; https://www.mskcc.org/cancer-care/doctors/andrea-pusic), visited the Center for Devices and Radiological Health (CDRH) at the US Food and Drug Administration. This is the third time the trio has been invited by FDA to present on Q-PORTFOLIO instruments (e.g., BREAST-Q http://qportfolio.org/breastq/, FACE-Q http://qportfolio.org/faceq/).
During the two-hour open meeting, with more than 50 FDA staff in attendance: Andrea spoke about the background and widespread use of the measures in clinical practice; Anne presented a detailed description of content development; and Stefan described how to maximize clinical interpretability and best practice guidelines for constructing PRO instruments. FDA feedback was very positive, including: high praise for the quality of the research; strong encouragement to qualify the Q-PORTFOLIO instruments; and a request for further training in concept-driven measurement, which is the cornerstone of Modus Outcomes’ methodology for evaluating existing, and developing new PRO instruments. Andrea, Anne and Stefan look forward to further interactions with FDA, with Modus Outcomes’ scientific team supporting teaching and training requirements.
If you are interested in learning more about what the FDA is raving about, please contact Andrea Murison (email@example.com) to schedule a training session with our experts.