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Scripps Team Finds Dearth of Behavioral, Psychological Consequences for DTC Test Takers

By Andrea Anderson

NEW YORK (GenomeWeb News) – Direct-to-consumer genetic testing does not lead to significant changes in behavior or anxiety, according to a study published online in the New England Journal of Medicine last night.

Researchers from the Scripps Research Institute used online questionnaires to gauge the behavioral and psychological consequences of DTC genetic testing for thousands of Navigenics Health Compass test consumers. Their findings suggest that the DTC test takers did not experience changes in anxiety, screening frequency, or other measured behaviors in the first few months after receiving their test results.

"This study is really one of the first of its kind, because it's the first to look at returning risk results for many conditions at once," lead author Cinnamon Bloss, a researcher affiliated with Scripps Genomic Medicine, Scripps Health, and the Scripps Translational Science Institute, told GenomeWeb Daily News.

Last fall, Bloss and her co-workers published a study in Genetics in Medicine in which they looked at the sort of information that DTC genetic test consumers were interested in learning. For the current study, they turned their attention to looking at how these consumers react to information provided by the tests.

"Proponents argue that providing this type of information directly to consumers may result in improved compliance with health-screening practices and more healthful lifestyle choices," they wrote. "Skeptics assert that such testing has the potential to cause harm, including anxiety and increased use of unnecessary and expensive screening and medical procedures."

To address such questions, Bloss and her co-workers initially enrolled 3,639 individuals who had gotten the Navigenics Health Compass test at a subsidized cost.

The participants included Scripps Health employees and their family members, patients, and individuals from health and technology companies in southern California and beyond. As such, Bloss emphasized, the study group does not represent the general population. Even so, she explained, it does seem to be fairly representative of early adopters who are currently using such tests.

Risk information was provided to participants based on their estimated lifetime risk of particular conditions as well as color-coded risk, the team explained, and participants had the opportunity to discuss their results with Navigenics' genetic counselors if they chose.

Prior to taking the test, participants received web-based questionnaires evaluating everything from their health and family history to their diet, exercise, and anxiety patterns.

Three months later, 2,037 of the participants were asked to complete follow-up questionnaires looking at post-test anxiety, use of screening tests, diet, exercise, and so on. The researchers also plan to do additional follow-up after a year.

"The evaluation of clinical effects … is particularly relevant, given the concern that direct-to-consumer testing may result in over-utilization of medical testing and resources," Bloss and her co-authors noted.

In general, the researchers did not detect any significant changes in the DTC genetic test takers' anxiety levels, diet, or exercise — results that are roughly consistent with those reported in studies of single-gene or single-disease test effects, Bloss noted.

Neither did they see an increase in the actual use of screening tests, though there was a significant increase in the number of medical screening tests that participants said they plan to have done in the future.

"People basically were reporting that, yes, they intended to get specific screening tests with greater frequency now that they knew their results," Bloss said, noting that the type of screening participants planned to get was related to their own specific risk information.

"To my mind, what that indicates is that the testing raised people's awareness about their health," she added, "and about the potential opportunities for proactive monitoring."

And while some individuals who appeared to be at higher risk of disease reported a slight uptick in test-related distress, the researchers noted, 90.3 percent of all participants did not. "According to the measure we used, the vast majority of participants in our study failed to report any test-related distress," Bloss said.

Those involved in the study emphasized that more research is needed to explore the long-term consequences of such DTC testing in a broader population. And, they say, the findings do not address whether such tests are clinically valid or useful.

Even so, because more than a quarter of test takers said they had discussed their test results with a physician, those involved in the study say the results point to a need for improved physician training and education related to DTC and other genomic tests.

"It really highlights the need for more education for physicians and more education for other types of healthcare professionals as well," Bloss said.

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