SHRINE: Clinical & population research by the numbers

Clinical research is all about numbers. A new informatics network called SHRINE could help make it easier to get find out if the numbers of patients are there to answer complex questions. (victoriapeckham/Flickr)
Ed. note: This morning at 8:15 EDT, Isaac Kohane, MD, PhD, will tell the audience at TEDMED 2013 about his goal of using every clinical visit to advance medical science. 

To preview his talk, we’ve updated a past Vector story about SHRINE, a system Kohane helped develop to allow scientists to use clinical data from multiple hospitals for research.

Clinical research really comes down to a numbers game. And those numbers can be the bane of the clinical researcher. If there aren’t enough patients in a study, its results could be statistically meaningless. But getting enough patients for a study, particularly for rare diseases, can be a daunting challenge.

The Shared Research Information Network (or SHRINE) could help solve this vexing problem. Developed through Harvard Catalyst by a team led by Isaac “Zak” Kohane, MD, PhD, director of Boston Children’s Hospital’s Informatics Program, SHRINE links the clinical databases of participating Harvard-affiliated hospitals—currently Boston Children’s Hospital, Beth Israel Deaconess Medical Center, Brigham and Women’s Hospital, Dana-Farber Cancer Institute and Massachusetts General Hospital—letting researchers at those hospitals see how many patients from those hospitals meet selected criteria.

Why is this important? Essentially, SHRINE turns clinical data into population data. With numbers of patients in hand, a researcher can see if observations they’ve made in the clinic from just two or three patients are part of a larger trend meriting study, or get an initial sense of whether, among the five hospitals currently in the system, there may be enough patients to conduct a trial aimed at answering a particular question.

So, for example, a diabetes researcher could see if there really is a rising trend in the number of boys with type 1 diabetes under the age of 10 coming to the hospital complaining of headaches after taking a new medication. Or a dermatologist could find out how many young adults using a topical treatment for eczema are experiencing allergic reactions.

“We can answer questions in seconds that would otherwise take years,” Kohane said in an interview with Harvard Medical School.. “Or that you could never even ask.” He illustrates this point with a multi-center study that looked at links between diabetes and a certain combination of statins and antidepressants, which brought together researchers from three different medical centers from across the U.S. “That took months and a big Rolodex,” he notes. “SHRINE takes seconds and a good idea.”

“We can answer questions in seconds that would otherwise take years,” Kohane says. “Or that you could never even ask.”

SHRINE’s power lies in the numbers. With every query, the system sifts through millions of patient records, searching demographics, diagnoses, medications and lab test results, presenting the researcher with the aggregate number of patient records as well as the number per institution.

“Wait!” you shout. “What about patient privacy? What about HIPAA?” SHRINE addresses privacy concerns by scrubbing away any identifiable information and providing only aggregate numbers. Also, SHRINE is a federated system; each participating hospital maintains complete control over the information in the databases that SHRINE peeks into. No actual data are ever transferred past the hospitals’ respective firewalls, only counts.

At the heart of SHRINE is a technology called Informatics for Integrating Biology and the Bedside (i2b2). This NIH-funded informatics framework—developed under Kohane’s watch—provides a common language and standards for securely exchanging clinical information across hospitals, universities and other institutions specifically for research, chiefly of the genomic variety. It can also help bridge between clinical and research information systems within an individual hospital.

But back to the numbers. Say you run a query and the results are inconclusive: there are some patients who have been seen at the five Harvard hospitals who meet the criteria of your search, but the number of patients is too small to confirm a trend or justify next steps.

The answer is to get more hospitals on board. The SHRINE team is piloting an expanded version of the network that adds six more medical and clinical research centers in California, Michigan, North Carolina, Ohio, Texas and Washington state. The expanded network—described in a recent paper in Public Library of Science One—has access to millions more patient records, giving population research on nearly any research question imaginable an even bigger boost…and helping improve patient care in the process.