title: Genetic and environmental risk assessment and colorectal cancer screening in an average-risk population: a randomized trial.
abstract: BACKGROUND
  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.
  
  
  OBJECTIVE
  To determine whether individualized genetic and environmental risk assessment (GERA) of CRC susceptibility improves adherence to screening in average-risk persons.
  
  
  METHODS
  2-group, randomized, controlled trial. (ClinicalTrials.gov: NCT0087360).
  
  
  METHODS
  4 medical school-affiliated primary care practices.
  
  
  METHODS
  783 participants at average risk for CRC who were not adherent to screening at study entry.
  
  
  METHODS
  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.
  
  
  METHODS
  The primary outcome was CRC screening within 6 months of study entry.
  
  
  RESULTS
  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]).
  
  
  CONCLUSIONS
  Only 1 personalized genetic and environmental interaction and 1 health behavior (CRC screening) were assessed.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  National Institutes of Health.
authors.forename: David S
authors.initials: DS
authors.lastname: Weinberg
authors.forename: Ronald E
authors.initials: RE
authors.lastname: Myers
authors.forename: Eileen
authors.initials: E
authors.lastname: Keenan
authors.forename: Karen
authors.initials: K
authors.lastname: Ruth
authors.forename: Randa
authors.initials: R
authors.lastname: Sifri
authors.forename: Barry
authors.initials: B
authors.lastname: Ziring
authors.forename: Eric
authors.initials: E
authors.lastname: Ross
authors.forename: Sharon L
authors.initials: SL
authors.lastname: Manne
mesh_terms: D000368:Aged; D015179:Colorectal Neoplasms / Q000175:diagnosis / Q000235:genetics*; D055088:Early Detection of Cancer / Q000706:statistics & numerical data*; D005260:Female; D005492:Folic Acid / Q000097:blood; D020022:Genetic Predisposition to Disease; D005820:Genetic Testing; D006801:Humans; D008297:Male; D042965:Methylenetetrahydrofolate Reductase (NADPH2) / Q000235:genetics; D008875:Middle Aged; D010349:Patient Compliance; D011110:Polymorphism, Genetic; D057285:Precision Medicine; D012306:Risk; D018570:Risk Assessment
chemical_list: D005492:Folic Acid; D042965:Methylenetetrahydrofolate Reductase (NADPH2)