Dr Donna Fitzsimons: Hard Endpoints in Cardiovascular Therapy Trials Aren’t the Most Important to Patients

Donna Fitzsimons, PhD, FESC, professor of nursing at the School of Nursing and Midwifery, Queen’s University Belfast, highlights the importance of patient-reported outcomes (PROs) in patient-centered cardiology care.

Transcript

Can you tell our audience what you discussed during your session on patient-centered care delivery?

We had a really interesting session today at the ESC Congress on patient-centered care. We had presentations from Jeroen Hendricks who really looked at atrial fibrillation, and then we had Femke [Piersma] who is a nurse practitioner in arrhythmia management, and then—as well as myself—we also had Gerhard Hindricks who is a leading trialist in the area of atrial fibrillation. So the focus was very much about how we can remodel our care pathway to make it more patient-centered.

What are some key factors contributing to the growing adoption of PROs in cardiology?

For many years, cardiology in particular and cardiovascular care more generally has focused on hard endpoints like mortality and hospital admission to predict outcomes and to evaluate the success of therapies. What we’re finding is that those trials are really difficult to do because you need much larger numbers and a much longer time to observe those outcomes. In actual fact, those aren’t the things that matter most to patients. Patients are really interested in softer endpoints like quality of life and issues such as their psychological and their social well-being on therapies as they live with and adjust to their cardiovascular condition. So, I would say a little bit slower than other disease entities such as cancer, for instance, the cardiovascular world is catching up and realizing that for us to be really hitting the mark and achieving what matters to patients, we need to look at a wider range of factors and include those whenever we’re evaluating the success of our therapies.

What is the process of creating and validating disease-specific and domain-specific PROs in cardiology, and how they differ from more generic PROs?

It’s really important that we are able to have generic patient-reported outcomes so that we can evaluate the impact of cardiovascular disease in comparison to other conditions. But, specifically, whenever we look at it, we obviously realize that cardiovascular disease is a chronic condition and that we need to monitor patients over a protracted period of time. So we need good tools that are sensitive to the changes in those very important but what we would term “softer” outcomes, such as quality of life, such as anxiety, depression, and other psychosocial issues.