ORIGINAL ARTICLEImpact of Direct-to-Consumer Predictive Genomic Testing on Risk Perception and Worry Among Patients Receiving Routine Care in a Preventive Health Clinic
Section snippets
PATIENTS AND METHODS
This study was conducted using a sequential mixed methods design, in which an initial phase of qualitative data collection and analysis provided the basis for a subsequent study in which quantitative data were collected and analyzed. After initial approval from the Mayo Clinic Institutional Review Board, we piloted the delivery of genomic risk results from a DTC product with 20 patients and their physicians to assist in the design of a larger trial (reported here) and to ensure the safety and
RESULTS
Of the 345 patient participants we approached, 64 (19%) refused, 131 (38%) did not respond after 2 follow-up telephone calls, and 150 (43%) agreed to participate. These 150 individuals were randomly assigned to either the intervention (n=74) or the control (n=76) group. Of the 74 patients in the intervention group, 61 (82%) completed the 1-week follow-up online survey; 54 (73%) completed the 1-year follow-up survey. Of the 76 patients randomly assigned to the control group, 57 (75%) completed
DISCUSSION
The results of the current study suggest that receiving predictive genomic risk information influences patients' perceptions of risk and levels of worry for developing a variety of conditions, but does so in different ways and to varying degrees for different conditions. Compared with participants who received usual care, patients who received genomic information had higher initial ratings of perceived risk and levels of worry for more than half of the conditions for which they received
CONCLUSION
To our knowledge, this is the first clinical trial to assess the use of predictive genomic risk assessment in a real-world preventive care setting. We found little evidence to suggest that predictive genomic risk information consistently influences risk perception or worry in the manner or degree that has been posited by some scientific critics and commentators, although our findings do suggest a possible transient effect in less common diseases. Because patients and physicians are most likely
Supporting Online Material
www.mayoclinicproceedings.com/content/86/10/933/suppl/DC1 Appendix A
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This study was funded jointly by Navigenics, Inc, and Mayo Clinic. Navigenics had no role in the design of the study or in data analysis. The views expressed In this study are those of the authors; Navigenics did not review the manuscript before submission.