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1.  Characteristics associated with informed consent for genetic studies in the ACCORD trial 
Contemporary clinical trials  2013;37(1):155-164.
Prior studies found some groups have lower genetic consent rates than others. Participant consent for genetic studies enables randomized trials to examine effects of interventions compared to control in participants with different genotypes.
Unadjusted and multivariate associations between genetic consent rates and participant, study, and consent characteristics in 9,573 participants approached for genetics consent in the multicenter Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial, which used a layered genetics consent.
Eighty-nine percent of eligible participants consented to genetic studies (“Any Consent”) and 64.7% consented to studies of any genes by any investigator (“Full Consent”), with similar rates in randomized groups. Controlling for multiple characteristics, African-Americans had lower consent rates than others (Any Consent Odds Ratio, OR = 0.62, p=0.0004; Full Consent OR = 0.67, p<0.0001). Those with high school or higher education had higher rates than less than high school graduation (Full Consent ORs 1.41-1.69, p-values <0.0001). Consent rates were lower when genetics consent was separate from the main trial consent on the same day (Any Consent OR 0.30; Full Consent OR 0.52, p values <0.0001) or on a subsequent day (Any Consent OR 0.70, p=0.0022; Full Consent OR 0.76, p=0.0002).
High rates of consent for genetic studies can be obtained in complex randomized trials, with lower consent rates in African-Americans, in participants with less than high-school education, and for sharing samples with other investigators. A genetics consent separated from the main trial consent was associated with lower consent rates.
PMCID: PMC3918951  PMID: 24355197
genetics; informed consent; recruitment
2.  Effect of Intensive Compared With Standard Glycemia Treatment Strategies on Mortality by Baseline Subgroup Characteristics 
Diabetes Care  2010;33(4):721-727.
To determine if baseline subgroups in the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial can be identified for whom intensive compared with standard glycemia treatment had different effects on all-cause mortality.
Exploratory post hoc intention-to-treat comparisons were made between intensive and standard glycemia groups on all-cause mortality by subgroups defined by baseline characteristics.
There were few significant interactions between baseline characteristics and effects of intensive versus standard glycemia treatment on mortality: self-reported history of neuropathy (hazard ratio [HR] 1.95, 95% CI 1.41–2.69) versus no history of neuropathy (0.99, 0.79–1.26; P value for interaction 0.0008), higher A1C (A1C >8.5%: HR 1.64, 95% CI 1.22–2.22; A1C 7.5–8.4%: 1.00, 0.75–1.34; A1C <7.5%: 1.00, 0.67–1.50; P value for interaction 0.04), and aspirin use (HR 1.45, 95% CI 1.13–1.85, compared with 0.96, 0.72–1.27, in nonusers; P value for interaction 0.03).
We found a remarkable similarity of effect from intensive compared with standard glycemia treatment on mortality across most baseline subgroups. No differential effect was found in subgroups defined by variables anticipated to have an interaction: age, duration of diabetes, and previous history of cardiovascular disease. The three baseline characteristics that defined subgroups for which there was a differential effect on mortality may help identify patients with type 2 diabetes at higher risk of mortality from intensive regimens for glycemic control. Further research is warranted.
PMCID: PMC2845012  PMID: 20103550
3.  The Scientific Foundation for Personal Genomics: Recommendations from a National Institutes of Health–Centers for Disease Control and Prevention Multidisciplinary Workshop 
The increasing availability of personal genomic tests has led to discussions about the validity and utility of such tests and the balance of benefits and harms. A multidisciplinary workshop was convened by the National Institutes of Health and the Centers for Disease Control and Prevention to review the scientific foundation for using personal genomics in risk assessment and disease prevention and to develop recommendations for targeted research. The clinical validity and utility of personal genomics is a moving target with rapidly developing discoveries but little translation research to close the gap between discoveries and health impact. Workshop participants made recommendations in five domains: (1) developing and applying scientific standards for assessing personal genomic tests; (2) developing and applying a multidisciplinary research agenda, including observational studies and clinical trials to fill knowledge gaps in clinical validity and utility; (3) enhancing credible knowledge synthesis and information dissemination to clinicians and consumers; (4) linking scientific findings to evidence-based recommendations for use of personal genomics; and (5) assessing how the concept of personal utility can affect health benefits, costs, and risks by developing appropriate metrics for evaluation. To fulfill the promise of personal genomics, a rigorous multidisciplinary research agenda is needed.
PMCID: PMC2936269  PMID: 19617843
behavioral sciences; epidemiologic methods; evidence-based medicine; genetics; genetic testing; genomics; medicine; public health
4.  Design of the Trial of Activity in Adolescent Girls (TAAG) 
Contemporary clinical trials  2005;26(2):223-233.
The primary aim of the Trial of Activity in Adolescent Girls (TAAG) is to test an intervention to reduce by half the age-related decline in moderate to vigorous physical activity (MVPA) in middle school girls. The intervention will be evaluated using a group-randomized trial involving 36 middle schools. The primary endpoint is the mean difference in intensity-weighted minutes (i.e., MET-minutes) of MVPA between intervention and comparison schools assessed using accelerometry.
The TAAG study design calls for two cross-sectional samples, one drawn from 6th graders at the beginning of the study and the second drawn from 8th graders at the end of the study following the 2-year implementation of the intervention. An important strength of this design over a cohort design is the consistency with the goals of TAAG, which focus on environmental-level rather than individual-level interventions to produce change. The study design specifies a recruitment rate of 80% and a smaller sample of girls at baseline (n=48 per school) than at follow-up (n=96 per school).
A two-stage model will be used to test the primary hypothesis. In the first stage, MET-weighted minutes of MVPA will be regressed on school, time (baseline or follow-up), their interaction, ethnicity and week of data collection. The second stage analysis will be conducted on the 72 adjusted means from the first stage. In the main-effects model, we will regress the follow-up school mean MET-weighted minutes of MVPA on study condition, adjusting for the baseline school mean.
The TAAG study addresses an important health behavior, and also advances the field of group-randomized trials through the use of a study design and analysis plan tailored to serve the main study hypothesis.
PMCID: PMC1430598  PMID: 15837442
Accelerometry; Cross-sectional design; Intervention; Middle School; Group-randomized trial; Physical activity

Results 1-4 (4)