Patients' Benefit-Risk Tradeoff Preference for Weight Reduction Devices in Obese Population

• Activity Number: 473
• Type: Topic Contributed
• Date/Time: Wednesday, August 7, 2013 : 8:30 AM to 10:20 AM
• Sponsor: Section on Bayesian Statistical Science
• Author(s): Martin P. Ho*+
• Companies: FDA/CDRH
• Keywords: Patient Preference ; Decision Analysis ; Survey ; Obesity ; CDRH ; FDA

Abstract

FDA has received anecdotal information from public testimonies, patient advocacy groups, and consumers about medical products during Advisory Panel Meetings. In 2011, the Center for Devices and Radiological Health at the FDA decided to explore a different approach and sponsored the Agency's first ever patient preference survey to collecting patient inputs through a scientifically validated stated-preference method. Weight-reduction devices were chosen to be the case study to evaluate this approach for obesity's significant impact on public health in the US. The purpose of this survey is to elicit the maximum risk tolerance of obese population in exchange for specific level of weight reduction for devices with combinations of product attributes, such as the safety profiles and diet restrictions. The survey was closed in November 2012 and data from over 600 representative respondents were collected. After providing the background of the survey and explaining the statistical methodology behind the survey, I will present the survey findings and discuss their potential influence on CDRH's regulatory process.