There was quite a lot of discussion around patient-centered outcomes at the recent annual meeting of the American College of Cardiology. A fine development! Colleagues of mine have been in the wilderness for years on this topic but maybe, in a post-COURAGE world, with more limited resources, we are finally starting to get it.
What are patient-centered outcomes? It’s actually a complicated concept, and there are numerous related terms, like "patient focused" and "patient related." In general terms, they are outcomes that are reported directly by patients themselves and not interpreted by an observer, and may include patient assessments of health status, quality-of-life, or satisfaction with care or symptoms.
In heart failure, we know that dyspnea is the most common presenting symptom during acute decompensation (Eur. Heart J. 2003;24:442-63) and that relief of dyspnea is important to patients (J. Am. Coll. Cardiol. 2008;52:1702-8). On the other hand, while dyspnea is a therapeutic target for drugs and devices, it is not at all clear that the Food and Drug Administration would agree to approve a safe intervention that relieves only this one symptom. In addition, a strong argument can be made that we don’t even really know how to measure dyspnea in a way that is valid, reproducible, and clinically meaningful. For example, if an intervention changes the average dyspnea score on a 7-point Likert scale from 1 ("slightly improved") to 2 ("moderately improved") when measured at 48 hours following an admission for heart failure, is that enough to warrant approval?
Clearly, to deliver patient-centered care, we have to measure the correct outcomes. But beyond that, we have to find a way to align the interests of disparate parties looking in at the doctor-physician interaction: the funding agencies (National Institutes of Health, Patient-Centered Outcomes Research Institute, Agency for Healthcare Research and Quality, and others), the regulatory bodies (Food and Drug Administration, Centers for Medicare and Medicaid Services) and third-party payers.
Patient-centeredness: Great concept, uncertain delivery.