Elsevier

Mayo Clinic Proceedings

Volume 86, Issue 10, October 2011, Pages 933-940
Mayo Clinic Proceedings

ORIGINAL ARTICLE
Impact of Direct-to-Consumer Predictive Genomic Testing on Risk Perception and Worry Among Patients Receiving Routine Care in a Preventive Health Clinic

https://doi.org/10.4065/mcp.2011.0190Get rights and content

Abstract

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.

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

REFERENCES (36)

  • NR Wray et al.

    Prediction of individual genetic risk to disease from genome-wide association studies

    Genome Res

    (2007)
  • J Lenzer et al.

    Knowing me, knowing you

    BMJ

    (2008)
  • MW Foster et al.

    Out of sequence: how consumer genomics could displace clinical genetics

    Nat Rev Genet

    (2008)
  • B Toner

    Though wary of DTC testing, some clinical geneticists see opportunity for education. GenomeWeb Daily News Web site. Published March 17, 2009

  • DJ Hunter et al.

    Letting the genome out of the bottle—will we get our wish?

    N Engl J Med

    (2008)
  • AL McGuire et al.

    An unwelcome side effect of direct-to-consumer personal genome testing: raiding the medical commons

    JAMA

    (2008)
  • US Government Accountability Office

    Testimony Before the Subcommittee on Oversight and Investigations, Committee on Energy and Commerce, House of Representatives. Direct-to-consumer genetic tests: misleading test results are further complicated by deceptive marketing and other questionable practices

  • T Zwillich

    FDA panel urges caution on genetic test kits. WebMD Web site. Published March 9, 2011

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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.

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    Copyright © 2011 Mayo Foundation for Medical Education and Research. Published by Elsevier Inc. All rights reserved.