How much is heart failure adversely affecting this patient’s life?
FDA Approved Medical Device Development Tool
The FDA has approved the Minnesota Living with Heart Failure Questionnaire as a Medical Device Development Tool (MDDT) for use in controlled clinical trials designed to test superiority or non-inferiority of medical devices in support of regulatory submissions. The patient-reported outcomes can be used to determine whether a treatment for heart failure is effective for improving patients’ quality of life by reducing the adverse impact of heart failure.
Quality of Life Questionnaire
The Minnesota Living with Heart Failure Questionnaire is a reliable and valid patient-oriented measure of the adverse effects of heart failure on their lives.
The questionnaire is comprised of 21 important physical, emotional and socioeconomic ways heart failure can adversely affect a patient’s life. After receiving brief standardized instructions, the patient marks a 0 (zero) to 5 scale to indicate how much each itemized adverse of heart failure has prevented the patient from living as he or she wanted to live during the past 4 weeks. The questionnaire is simply scored by summation of all 21 responses.
The instrument can be used as a key outcome measure in studies and evaluations of outpatients with symptomatic (NYHA class II to IV) heart failure with a reduced or preserved ejection fraction. This patient-reported outcome can be used to determine whether a treatment for heart failure is effective for improving patients’ quality of life by reducing the adverse impact of heart failure.
MLHFQ Detailed Information
More detailed information about the Minnesota Living with Heart Failure Questionnaire is available in the FDA MDDT Qualification Package. A license from the University of Minnesota is required before using the Questionnaire.
The University of Minnesota only provides the Questionnaire in English but the Minnesota Living with Heart Failure Questionnaire license allows you to translate the Questionnaire without any further licensing from the University of Minnesota as long as all translations are used for the same study or protocol. The MAPI Research Institute provides validated translations of the Questionnaire.