David S. Weinberg, MD, MSc; Ronald E. Myers, PhD; Eileen Keenan, MA; Karen Ruth, MS; Randa Sifri, MD; Barry Ziring, MD; Eric Ross, ScM, PhD; Sharon L. Manne, PhD
Acknowledgment: The authors thank James Cocroft, Anett Petrich, Heidi Kelly, Thomas Wolf, and the members of the Fox Chase Cancer Center Cancer Genomics Facility.
Grant Support: By grants R01CA112230 (Dr. Weinberg) and P30 CA006927 from the National Institutes of Health.
Disclosures: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M14-0765.
Reproducible Research Statement:Study protocol: Available from Dr. Weinberg (e-mail, email@example.com). Statistical code and data set: Available from Dr. Ross (e-mail, firstname.lastname@example.org).
Requests for Single Reprints: David S. Weinberg, MD, MSc, Fox Chase Cancer Center, 333 Cottman Avenue, Philadelphia, PA 19111; e-mail, email@example.com.
Current Author Addresses: Drs. Weinberg and Ross, Ms. Keenan, and Ms. Ruth: Fox Chase Cancer Center, 333 Cottman Avenue, Philadelphia, PA 19111.
Dr. Myers: Department of Medical Oncology, Division of Population Science, Thomas Jefferson University, 834 Chestnut Street, Suite 314, Philadelphia, PA 19107.
Dr. Sifri: Department of Family and Community Medicine, Thomas Jefferson University, 1015 Walnut Street, Suite 401, Philadelphia, PA 19107.
Dr. Ziring: Department of Internal Medicine, Thomas Jefferson University, 833 Chestnut Street, Suite 701, Philadelphia, PA 19107.
Dr. Manne: 10 Park Avenue, Apartment 16JH, New York, NY 10016.
Author Contributions: Conception and design: D.S. Weinberg, R.E. Myers, R. Sifri, E. Ross, S.L. Manne.
Analysis and interpretation of the data: D.S. Weinberg, R.E. Myers, K. Ruth, R. Sifri, E. Ross, S.L. Manne.
Drafting of the article: D.S. Weinberg, R.E. Myers, K. Ruth, R. Sifri, B. Ziring, E. Ross, S.L. Manne.
Critical revision of the article for important intellectual content: D.S. Weinberg, R.E. Myers, R. Sifri, S.L. Manne.
Final approval of the article: D.S. Weinberg, R.E. Myers, K. Ruth, R. Sifri, B. Ziring, E. Ross, S.L. Manne.
Provision of study materials or patients: R.E. Myers, R. Sifri, B. Ziring.
Statistical expertise: K. Ruth, E. Ross.
Obtaining of funding: D.S. Weinberg, E. Ross, S.L. Manne.
Administrative, technical, or logistic support: D.S. Weinberg, R.E. Myers, E. Keenan, R. Sifri, B. Ziring, E. Ross.
Collection and assembly of data: D.S. Weinberg, R.E. Myers, E. Keenan, R. Sifri.
Weinberg DS, Myers RE, Keenan E, Ruth K, Sifri R, Ziring B, et al. Genetic and Environmental Risk Assessment and Colorectal Cancer Screening in an Average-Risk Population: A Randomized Trial. Ann Intern Med. 2014;161:537-545. doi: 10.7326/M14-0765
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Published: Ann Intern Med. 2014;161(8):537-545.
New methods are needed to improve health behaviors, such as adherence to colorectal cancer (CRC) screening. Personalized genetic information to guide medical decisions is increasingly available. Whether such information motivates behavioral change is unknown.
To determine whether individualized genetic and environmental risk assessment (GERA) of CRC susceptibility improves adherence to screening in average-risk persons.
2-group, randomized, controlled trial. (ClinicalTrials.gov: NCT0087360)
4 medical school–affiliated primary care practices.
783 participants at average risk for CRC who were not adherent to screening at study entry.
Participants were randomly assigned to usual care or GERA, which evaluated methylenetetrahydrofolate reductase polymorphisms and serum folate levels. On the basis of prespecified combinations of polymorphisms and serum folate levels, GERA recipients were told that they were at elevated or average risk for CRC.
The primary outcome was CRC screening within 6 months of study entry.
Overall screening rates for CRC did not statistically significant differ between the usual care (35.7%) and GERA (33.1%) groups. After adjustment for baseline participant factors, the odds ratio for screening completion for GERA versus usual care was 0.88 (95% CI, 0.64 to 1.22). Within the GERA group, screening rates did not significantly differ between average-risk (38.1%) and elevated-risk (26.9%) participants. Odds ratios for elevated- versus average-risk participants remained nonsignificant after adjustment for covariates (odds ratio, 0.75 [CI, 0.39 to 1.42]).
Only 1 personalized genetic and environmental interaction and 1 health behavior (CRC screening) were assessed.
In average-risk persons, CRC screening uptake was not positively associated with feedback from a single personalized GERA. Additional studies will be required to evaluate whether other approaches to providing GERA affect screening utilization differently. These findings raise concern about the effectiveness of moderately predictive assessment of genetic risk to promote favorable health care behavior.
National Institutes of Health.
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Gastroenterology/Hepatology, Hematology/Oncology, Cancer Screening/Prevention, Gastrointestinal Cancer, Colorectal Cancer.
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