Cardiovascular research has traditionally focused on hard clinical endpoints such as markers of disease progression, adverse events and death. But now researchers are calling for more studies that incorporate the viewpoints of patients and caregivers, both in trial design and execution and in measuring outcomes like quality of life, time off work, out-of-pocket expense and caregiver burden.

Sean P. Collins, MD, MSc, from Vanderbilt University Medical Center, and colleagues analyzed this topic in a special communication published online Oct. 11 in JAMA Cardiology. Engaging patients, caregivers and other stakeholders in the medical community can be a daunting task, the authors acknowledged, but it’s one worth pursuing.

“Clinical trial end point selection has traditionally focused on surrogate or direct markers of disease improvement without emphasis on patient-centered outcomes,” Collins et al. wrote. “When such measures are included, they have focused largely on symptoms and quality of life as determined by clinicians. This approach may not necessarily reflect what matters most to patients, caregivers, or the broader health care community; the benefits derived from such research may not be relevant, applicable, or understandable to those it was intended to help.”

The Patient-Centered Outcomes Research Institute (PCORI) was authorized by the U.S. Congress in 2010 and generates most federally funded patient and caregiver research. It has also brought greater attention to the value of patient-centered trials, according to Collins and co-authors.

While patient-centered clinical trials require a complete rethink, Collins et al. provided specific examples of how patient feedback changed the design of studies. These suggestions came as the result of social media interaction, community engagement sessions and focus groups.

“A key aspect of collaboration is ensuring an understanding of the underlying scientific considerations guiding the choice of study design and the feasibility of certain outcomes being considered for the study,” the researchers wrote.

In addition, stakeholders should “be involved in interpretation and delivery of results to their local-, social- and disease-based communities, serving to bridge the divide between data-heavy research findings and their practical implications. Understandably, some level of stakeholder education and training may be needed to prepare them for such roles and to foster success.”

Investigators in the medical field, as well, will need to be educated on local, regional and national resources and new techniques that engender useful feedback from patients and caregivers.

“Patient and caregiver involvement in cardiovascular clinical trial design was once an exploratory activity of brave pioneers,” wrote Bray Patrick-Lake, MFS, and Adrian F. Hernandez, MD, MHS, both with Duke University, in an invited commentary. “However, evidence of timing, practices, and valuable contribution has amassed to the point of pushing the field past the tipping point of certainty when answering the question, when should I be involving patients and caregivers in my work? The answer from here forth is always, early, and often.”