Project: Heart Failure Patient Preference Information Study

MDIC catalyzed a multi-stakeholder effort, including six different heart failure device companies, to generate and analyze patient preference information from cohorts of heart failure patients. This information was assessed to better understand patients’ willingness to accept potential risks associated with use of a device in exchange for potential benefits in the form of functional status and extended survival.

Full Summary

This project represents the second disease-specific patient preference study effort undertaken by MDIC. The aim of this study was to understand the preferences of patients living with heart failure to help advance the science of patient preference regulatory assessment and to inform clinical trial designs for heart failure devices. A unique aspect of this project was the engagement of six medical device sponsor companies, which all participated collaboratively in the effort based on a shared recognition of the importance of advancing a patient preference study in this disease space. In addition to the companies, patients, patient advocates, health care providers, FDA officials and patient preference information study experts were all engaged in developing and conducting a study to develop heart failure patient preference information.

Objectives of the study included applying best-practice stated-preference methods to quantify patients’ willingness to accept therapeutic risks in exchange for improved effectiveness. Additionally, the study aimed to engage patients, providers, device industry representatives, and preference research experts in a collaborative effort focused on a disease state rather than a specific device or development program. Results from the study included important findings about patients’ willingness to accept the risk of mortality in exchange for the possibility of extended survival with a certain level of functional status. Results from this effort have been incorporated into manuscripts and presented via webinar through MDIC. Published manuscripts will be posted to this Resource Library as they become available. Additionally, this initiative has been leveraged to provide learnings for MDIC efforts to advance use of patient preference information within clinical trial design.

Articles in the

Heart Failure Patient Preference Information Study