Effects of genetic and environmental risk assessment feedback on colorectal cancer screening adherence.

Little is known about the impact of genetic and environmental risk assessment (GERA) feedback on colorectal cancer (CRC) screening. In a recently completed randomized trial, primary care patients received GERA feedback based on a blood test for genetic polymorphisms and serum folate level (GERA Group) versus usual care (Control Group). Subsequently, participants were offered CRC screening. Among participants who received GERA feedback, being at elevated risk was negatively associated with prospective CRC screening adherence. Secondary analyses of data from this study were performed to identify independent predictors of adherence among participants who received GERA feedback. We obtained baseline survey, follow-up survey, and endpoint medical records data on sociodemographic background, knowledge, psychosocial characteristics, risk status, and adherence for 285 GERA Group participants. Univariate and multivariable analyses were performed to identify predictors of CRC screening adherence. Following a 6-month outcomes observation period, we also conducted two focus groups with GERA Group participants to assess their perceptions of GERA risk feedback and screening. Content analyses of focus group data were evaluated to gain insights into participant response to risk feedback. Overall, half of GERA Group participants adhered to screening within 6 months after randomization. Multivariable analyses showed a statistically significant interaction between race and GERA feedback status relative to screening adherence (p = 0.043). Among participants who received average risk feedback, adherence was comparable among whites (49.7 %) and nonwhites (54.1 %); however, among those at elevated risk, adherence was substantially higher among whites (66.7 %) compared to nonwhites (33.3 %). Focus group findings suggest that whites were more likely than nonwhites to view elevated risk feedback as a prompt to screen. In response to receiving elevated risk feedback, nonwhites were more likely than whites to report feeling anxiety about the likelihood of being diagnosed with CRC. Further research is needed to explore race-related CRC screening differences in response to GERA feedback.

Genetic and environmental risk assessment and colorectal cancer screening in an average-risk population: a randomized trial.

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. DESIGN: 2-group, randomized, controlled trial. (ClinicalTrials.gov: NCT0087360). SETTING: 4 medical school-affiliated primary care practices. PARTICIPANTS: 783 participants at average risk for CRC who were not adherent to screening at study entry. INTERVENTION: 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. MEASUREMENTS: 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]). LIMITATION: Only 1 personalized genetic and environmental interaction and 1 health behavior (CRC screening) were assessed. CONCLUSION: 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. PRIMARY FUNDING SOURCE: National Institutes of Health.

Text Messaging in the Patient-Centered Medical Home to Improve Glucose Control and Retinopathy Screening.

Purpose: To evaluate the effectiveness of a text messaging program (TMP) to improve glucose control, retinopathy screening (RS) rates, and self-care behaviors in patients with uncontrolled type 2 diabetes. Methods: A single-group design with a quasi-systematic random sample (n=20) received educational/exhortational text messages on their cellular phones for 3 months. Subjects, 12 of whom identified as a minority ethnicity, were mostly male, aged 27-73 years. Results: Glucose control and RS rates improved significantly. Subjects (>70%) reported changes in self-care behaviors. Conclusion: Leveraging ubiquitous technology, a TMP for patients with limited access to healthcare education, holds promise.

Advantages of extended-release metformin in patients with type 2 diabetes mellitus.

Metformin is a first-line pharmacological treatment for patients with type 2 diabetes mellitus because of its favorable overall profile, including its glucose-lowering ability, weight-neutral effects, and low risk of hypoglycemia; however, gastrointestinal (GI) intolerance may limit use in some patients. Extended-release metformin improves GI tolerability, allows once-daily dosing, and is currently available in multiple branded and generic formulations; however, it is more expensive than immediate-release metformin. Maximum plasma metformin concentrations are reached more slowly with the extended-release formulation compared with conventional immediate-release metformin, although both provide similar exposure at a given total daily dose. Extended-release metformin is as effective as immediate-release metformin in patients newly started on metformin and those switched from the immediate-release formulation, with similar weight-neutral effects. Tolerability is generally comparable, although patients switched from the immediate-release formulation--even those switched due to GI intolerance--are often better able to tolerate the extended-release formulation. Based on studies of extended-release formulations in other disease states, metformin extended-release formulation has the potential to improve patient adherence with a simpler dosing regimen and increased tolerability. Increased adherence may result in greater glycemic control, and in turn, improve outcomes and lower health care usage and costs. Extended-release metformin provides an appropriate option for patients with type 2 diabetes mellitus who require several medications to achieve glycemic control or manage comorbid conditions, and for those who have GI intolerance with the immediate-release formulation.

A randomized trial of genetic and environmental risk assessment (GERA) for colorectal cancer risk in primary care: trial design and baseline findings.

PURPOSE: This paper describes an ongoing randomized controlled trial designed to assess the impact of genetic and environmental risk assessment (GERA) on colorectal cancer (CRC) screening. METHODS: The trial includes asymptomatic patients who are 50-79years and are not up-to-date with CRC screening guidelines. Patients who responded to a baseline telephone survey are randomized to a GERA or Control group. GERA group participants meet with a nurse, decide whether to have a GERA blood test (a combination of genetic polymorphism and folate), and, if tested, receive GERA feedback. Follow-up telephone surveys are conducted at 1 and 6months. A chart audit is performed at 6months. RESULTS: Of 2,223 eligible patients, 562 (25%) have enrolled. Patients who enrolled in the study were significantly younger than those who did not (p<0.001). Participants tended to be 50-59years (64%), female (58%), white (52%), married (51%), and have more than a high school education (67%). At baseline, most participants had some knowledge of CRC screening and GERA, viewed CRC screening favorably, and reported that they had decided to do screening. Almost half had worries and concerns about CRC. CONCLUSIONS: One in four eligible primary care patients enrolled in the study. Age was negatively associated with enrollment. Prospective analyses using data for all participants will provide more definitive information on GERA uptake and the impact of GERA feedback.