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Duke Seed Funding Helps Shape a National Research Framework

Just a year into seed funding from the Office of the Provost, researchers from Duke’s ORBIT Hub published a scientific statement endorsed by the American Heart Association.

The statement represents an early national-level outcome for ORBIT, which grew out of interdisciplinary collaborations that began through Bass Connections and Data+ projects. With support from an Interdisciplinary Hubs grant, the group expanded its work to advance the use of real-world health data in research. Those collaborations helped set the intellectual foundation for the statement.

Associate Professor of Neurology Brian Mac Grory is the lead author of “Observational Comparative Research in Cardiovascular and Brain Health and Disease.” We asked him to explain the importance of this work.

Q&A

What is observational comparative research?

Observational comparative research is a way of studying health care by looking carefully at what happens in the real world, rather than assigning patients to treatments as part of a randomized clinical trial.

In observational research, the treatment decisions have already happened as part of routine care. Researchers then use existing data — for example, from electronic health records, insurance claims, clinical registries or hospital databases — to compare outcomes among patients.

A simple example would be comparing two commonly used treatments for stroke prevention. If some patients receive Treatment A and others receive Treatment B in routine practice, observational comparative research asks: After accounting as carefully as possible for differences between those patients, which treatment appears to be associated with better outcomes, fewer complications or lower risk?

The key phrase is “as carefully as possible.” Because patients are not randomly assigned, the groups may differ in important ways. Patients who receive one treatment may be older, sicker, more likely to have certain risk factors, or treated at different hospitals. The goal of high-quality observational comparative research is to design the study and analyze the data in a way that makes those comparisons as fair, transparent, and clinically meaningful as possible.

Why is this scientific statement significant?

A scientific statement is a professional document that is one tier below a full guideline. In this form of publication, a group of authors establish a consensus around a given topic, identify gaps and opportunities in the literature, and offer considerations for best practice. In the process, these types of publications tend to set the standard for a given disease or condition for many years.

This statement is unique because it concerns an entire philosophy of research as opposed to an individual condition. It will set the tone for how this critical form of research is done in the U.S. for many years to come.

How did you and your colleagues go about this work?

The work was essentially a structured, multidisciplinary effort to ask: When investigators use real-world health data to compare treatments or strategies, what principles should guide them so that the results are reliable and useful?

That required bringing together perspectives from clinical medicine, epidemiology, biostatistics, causal inference, data science, health services research and evidence generation.

What’s next for ORBIT?

The next step is to move from articulating best practices to putting them into action.

The scientific statement helps define what rigorous observational comparative research should look like. The ORBIT Hub can build on that by developing practical tools, applied research projects, training opportunities and collaborative infrastructure that help investigators use real-world data responsibly.

The Hub’s work will focus on helping teams turn routinely collected health data into credible evidence.

Connect With ORBIT

Visit the Hub’s website
Sign up for its mailing list.
See this year’s Bass Connections project, Data Science for Cardiovascular and Brain Health Research.