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Coriell, OSU Studying Whether Genomic Risk Data and Counseling Changes Patient, Doctor Behavior

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Originally published Feb. 8.

The Coriell Institute for Medical Research and Ohio State University Medical Center will incorporate genetic risk data into the electronic medical records of patients with heart conditions in order to study how this information impacts care.

The aim of the effort is to figure out whether genomic risk data, in combination with genetic counseling, leads to changes in patient behavior. The investigators will determine whether physicians use this information when it is made available to them via EMRs. OSU and Coreill also plan to look at whether genomic data in EMRs can be used to "develop best practices for the field."

The collaboration will involve between 30 to 35 cardiologists and primary care physicians at OSU, as well as 1,800 of their patients who have been diagnosed with congestive heart failure or hypertension. OSU will enter genomic data linked to disease predisposition and drug response into patient EMRs, as well as observations about how patients use their personal genomic profile to make healthcare choices.

The effort is part of the Coriell Personalized Medicine Collaborative, which was launched in 2007 and aims to enroll 10,000 participants to study whether genomic data impacts behavior. Currently the project provides participants with information about their genetic predisposition for coronary artery disease, lupus, melanoma, age-related macular degeneration, prostate cancer, iron overload, and type 1 and type 2 diabetes. In the future, CPMC plan to inform participants of gene mutations that can impact their response to therapies, such as the anti-platelet drug Plavix.

To recruit study participants, Coreill has partnered with several hospitals and healthcare providers, including Cooper University Hospital, Fox Chase Cancer Center, Virtua Health, Helix Health of Connecticut, as well as the Ohio State University Medical Center.

“By providing personal genetic risk data directly to both physicians and their patients, we have a unique opportunity to examine how personalized medicine can be used in the clinic,” Michael Christman, president and CEO of Coriell, said in a statement “This is an important step toward effectively integrating genome information into routine medical care.”

Congestive heart failure and hypertension are chronic conditions that have a high mortality rate in the US. Coriell estimates that 5.7 million people in the US will have congestive heart failure this year, causing as many as 300,000 deaths. As much as 25 percent of adults in the US have hypertension. "As chronic heart disease patients are often treated with multiple medications, personalized medicine can help physicians make the best prescribing decisions and also identify disease risks, resulting in safer and more accurate care for patients," Coriell said.

Coriell will ask participants to complete surveys and will offer genetic counseling to all participants at no cost via phone and e-mail, to ensure they understand the information presented to them and what it might mean for their health.

Some study participants will be asked by the Coriell/OSU Medical Center to come in for an in-person genetic counseling session. Differences between the participants who received counseling through phone and e-mail and those who received in-person counseling "will provide insight into the role genetic counselors play as educators in personalized medicine," Coriell said.

Several other groups are currently investigating the use of genomic information by doctors and consumers.

The results of a study conducted by Scripps Translational Science Institute and published last month in the New England Journal of Medicine showed that information about people's genetic predisposition to various diseases had little impact on their anxiety levels. The interim results of the study also showed that genetic information did not change diet, exercise behavior, or the use of screening tests in the overall study population. However, the data do suggest that 25 percent of study participants who discussed their DNA data with their doctors did change their lifestyle and diet (PGx Reporter 1/26/11, 1/12/11).

Another study conducted by Medco and presented at the American Society for Human Genetics in November showed that Medco's personalized medicine program has been successful at driving physician and patient adoption of PGx testing to dose the anticoagulant warfarin and to guide the cancer treatment tamoxifen to best responders (PGx Reporter 11/10/10).

At the beginning of the two-year study, Medco gauged that only 1.7 percent of patients received genetic testing for warfarin and 2.3 percent of those on tamoxifen received genetic testing as part of clinical care. However, Medco found that when pharmacists could educate doctors and their patients about PGx testing, they were able to convince more than 4,000 doctors to consider whether genetic testing to dose warfarin was appropriate for their patients. Through this same process, around 1,500 physicians, 63 percent of them oncologists, agreed to consider their patients for genetic testing ahead of tamoxifen treatment. There was no cost for patients or physicians for agreeing to PGx testing in the study.

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