Outcomes Research: What It Is, What It's Not, and Why It's Important For FITs

February 15, 2017 | Dhaval Kolte, MD, PhD

The term "outcomes research" was first introduced in 1998 by Clancy and Eisenberg in their article in Science, which stated that "outcomes research – the study of the end results of health services that takes patients' experiences, preferences, and values into account – is intended to provide scientific evidence relating to decisions made by all who participate in health care." Realizing the importance and need for outcomes research in cardiovascular diseases, the National Heart, Lung, and Blood Institute of the National Institutes of Health convened a working group on 'Outcomes Research in CVD' in 2004. The working group defined outcomes research as "applied clinical research that generates knowledge to improve clinical decision-making and health care delivery to optimize patient outcomes. It is the study of the delivery and consequences of health care on outcomes from the perspective of patients, providers, and the health care system."

While these two definitions elegantly capture the essence of what outcomes research is, there are still some common misunderstandings and misconceptions about this field. These have been previously addressed in much detail by Harlan M. Krumholz, MD, SM, FACC, in his article in Circulation: Cardiovascular Quality and Outcomes. I will briefly highlight two of these, which in my experience, are still the most common misconceptions about outcomes research among residents and FITs. First, outcomes research is not defined by its use of observational methodology and existing databases. Rather, it is defined by its objective or the very nature of the question it seeks to answer. Thus, outcomes research can utilize methodology of observational studies (retrospective or prospective), randomized trials, cost-effectiveness/economic analysis, surveys, or meta-analysis, whichever is most suited to the specific research question. Second, outcomes research is not a fad, but is now a well-established field that has grown exponentially over the past decade and a half. This is evident from the increasing number of centers for cardiovascular outcomes research across the country as well as internationally, some of which now even offer formal training programs in outcomes research.

So, why is it important for FITs to engage in cardiovascular outcomes research? As FITs and cardiologists we are trained to practice evidence-based medicine. However, despite our extensive knowledge of randomized controlled trials and best practices, we often lack basic information about contemporary patterns of care, the effectiveness of different clinical strategies in actual clinical practice (at the community, state, national and international level), and the barriers to delivering the best available care and achieving the maximal potential of various interventions. We need information about how to engage patients in decision making, the cost-effectiveness of treatments, and the impact of health care policy decisions on various patient outcomes.

Outcomes research can provide answers to most if not all of these questions. Outcomes research is not a single field, but rather allows you to work with experts across disciplines including basic/translational scientists, clinicians, epidemiologists and biostatisticians. It increases your knowledge and understanding of various research methodologies as mentioned before. Finally, at the individual or personal level, engaging in outcomes research also enables you to collaborate and share ideas with peers, and most importantly, seek mentors both at and outside your institution with whom you can develop life-long relationships. As someone once said, "If you want to be incrementally better: be competitive. If you want to be exponentially better: be cooperative."

This article was authored by Dhaval Kolte, MD, PhD, a Fellow in Training (FIT) at Brown University in Providence, RI, and the FIT Member of the ACC/AHA Task Force on Performance Measures.

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