posted by David H. Ledbetter, Geisinger
on October 12, 2016
When Geisinger Health System made the then-controversial decision to inform research participants in our MyCode Community Health Initiative of clinically actionable results that indicate an increased risk for cancer or heart disease, two things immediately changed: First, what was purely a research program suddenly became an embryonic precision medicine program as we began to inform research “subjects” that they had genetic mutations where management and treatment might be beneficial. And, second, from that point forward, what were research subjects became instead research partners.
Approaching 125,000 research partners later – and with a more than 85 percent voluntary consent rate – we must be doing something right and a lot of people ask us what it is.
We are fortunate to have a long tradition of health care service in our communities, dating back 100 years. Because of a highly stable population in our core service areas, generations of the same families have been Geisinger patients and have long known us for delivering quality care. We are not some faraway, distant and faceless research institution. We are in the community. Every day. This has enabled us to become a trusted gatekeeper – people trust us to keep their private health information safe and we take that trust very seriously.
Together with that track record, it is our willingness to consult with our patient-partners to shape the administration of the program and communicate with them throughout that has helped transform the MyCode Community Health Initiative from an idea into one of the nation’s first research/clinical precision medicine programs.
There was no intention originally to return clinical results to patients from this research program.
It was only after consultation with Geisinger patients, and substantial internal discussion, that the health system switched gears to include the return of clinically actionable results.
It was a questionable decision at the time in 2013 as there was not then — and still is not— any industry consensus on the return of clinically actionable genomic results to individual participants in a research program.
Three things conspired to make that complex decision become a moral imperative for Geisinger: in the first place, the fact that these research “subjects” are our patients first; secondly, the simple nature of genomic knowledge as a potential predictor of future health or disease; and, third, the clear desires of the research participants themselves when we asked them.
Six focus groups and other fora were held in 2012 and patients told us by large majorities that they wanted to know all their results. They wanted their doctors or other providers to know their results. And they wanted Geisinger to develop educational materials and expert support systems to help communicate those results.
Patient engagement is known to lead to better health outcomes and what we found at Geisinger with MyCode was that engaging patients as research partners paves the way to engaging them as partners in their own health care too. These are exactly the principles behind the national Precision Medicine Initiative.
The final post in this series will highlight several stories of health improving and even life-saving experiences from the program to date.
David H. Ledbetter is Executive Vice President & Chief Scientific Officer at Geisinger Health System.