Abstract
INTRODUCTION: The patient's voice in shared decision-making has progressed from physician's office to regulatory decision-making for medical devices with FDA's Patient Preference Initiative. A discrete-choice preference measure for upper limb prosthetic devices was developed to investigate patient's risk/benefit preference choices for regulatory decision making. METHODS: Rapid ethnographic procedures were used to design a discrete-choice measure describing risk and benefits of osseointegration with myoelectric control and test in a pilot preference study in adults with upper limb loss. Primary outcome is utility of each choice based conjoint (CBC) attribute using mixed-effects regression. Utilities with and without video, and between genders were compared. RESULTS: Strongest negative preference was for avoiding infection risk (B = -1.77, p < 0.001) and chance of daily pain (B = -1.22, p, 0.001). Strongest positive preference was for attaining complete independence when cooking dinner (B = 1.62, p < 0.001) and smooth grip patterns at all levels (B = 1.62, B = 1.28, B = 1.26, p < 0.001). Trade-offs showed a 1% increase in risk of serious/treatable infection resulted in a 1.77 decrease in relative preference. There were gender differences, and where video was used, preferences were stronger. CONCLUSIONS: Strongest preferences were for attributes of functionality and independence versus connectedness and sensation but showed willingness to make risk-benefit trade-offs. Findings provide valuable information for regulatory benefit-risk decisions for prosthetic device innovations. TRIAL REGISTRATION: This study is not a clinical trial reporting results of a health care intervention so is not registered.