FDA Names U Heart Patient Survey a Go-To for Device Makers
A University of Minnesota patient questionnaire developed to improve treatments for heart failure was one of the first tools accepted into a new Food and Drug Administration program designed to help medical device makers develop and evaluate new medical devices.
The Minnesota Living with Heart Failure Questionnaire, a 21-question survey that determines how treatment for heart failure is affecting an individual patient’s life, received FDA Medical Device Development Tools (MDDT) status in March. This qualification means the FDA has reviewed and affirmed evidence that the questionnaire is a reliable resource for device makers to use in gauging how new heart failure treatments affect patients’ quality of life.
Heart failure is a condition where the heart doesn’t pump blood as well as it should, causing symptoms such as shortness of breath, fatigue, swelling in the legs and feet, and difficulty concentrating. More than 6.5 million adults in the US are living with the disease, according to the American Heart Association. It’s a separate condition from a heart attack, where blocked arteries cut off blood flow, but the two are related—a heart attack can cause damage that leads to heart failure.
While the MDDT qualification is new, the Minnesota Living with Heart Failure Questionnaire itself has a long history of use. It was first designed in 1984 by the late Thomas Rector, Ph.D., formerly an adjunct associate professor in the U’s College of Pharmacy, and Jay Cohn, M.D., professor of medicine in the Medical School’s Cardiovascular Division.
At the time of development, many treatments took symptoms into account when measuring treatment effectiveness, Cohn said, but this questionnaire was the first to focus on quality of life.
“I came to the realization that we could not allow mortality or survival to be the only criteria for success in treating heart failure,” he said. “We had to consider the net effect on the patient’s quality of life.”
The questionnaire asks patients living with heart failure to rate the physical, social, and emotional limitations they face, with questions ranging from their ability to do household chores and climb stairs, to whether they can still enjoy time with family and friends, to whether they feel worried or depressed.
The tool helps to weigh the benefits of a treatment against any burdens that may accompany it. For example, one treatment might require surgically implanting a device in the patient’s heart that is powered through a battery pack worn outside the body. While such a treatment could help lessen their symptoms, the patient might have to make lifestyle changes to deal with the possibility of surgical complications or to accommodate wearing a battery pack at all times.
In 1993, the University began licensing the survey for commercial evaluation, nonprofit research, patient care, and educational purposes. Nearly 35 years later, more than 2,000 companies, hospitals, and universities worldwide have licensed the questionnaire. The tool was described as a “valid and reliable indicator of quality of life in heart failure patients” in a 2017 Journal of Nursing Scholarship validation study.
Despite his excitement for the questionnaire’s MDDT status, Cohn expressed sympathy that Rector—who had worked hard not only during the development of the questionnaire, but also to submit it for the MDDT program—passed away before he could see the qualification come through.
“This is an important milestone for the U,” Cohn said. “It’s a reassuring affirmation of the rationale behind the original development of the tool.”