Objective: To assess the impact of direct-to-consumer (DTC) predictive genomic risk information on perceived risk and worry in the context of routine clinical care.
Patients and methods: Patients attending a preventive medicine clinic between June 1 and December 18, 2009, were randomly assigned to receive either genomic risk information from a DTC product plus usual care (n=74) or usual care alone (n=76). At intervals of 1 week and 1 year after their clinic visit, participants completed surveys containing validated measures of risk perception and levels of worry associated with the 12 conditions assessed by the DTC product.
Results: Of 345 patients approached, 150 (43%) agreed to participate, 64 (19%) refused, and 131 (38%) did not respond. Compared with those receiving usual care, participants who received genomic risk information initially rated their risk as higher for 4 conditions (abdominal aneurysm [P=.001], Graves disease [P=.04], obesity [P=.01], and osteoarthritis [P=.04]) and lower for one (prostate cancer [P=.02]). Although differences were not significant, they also reported higher levels of worry for 7 conditions and lower levels for 5 others. At 1 year, there were no significant differences between groups.
Conclusion: Predictive genomic risk information modestly influences risk perception and worry. The extent and direction of this influence may depend on the condition being tested and its baseline prominence in preventive health care and may attenuate with time.
Trial registration: ClinicalTrials.gov NCT00782366.