To achieve ‘Personalized Medicine’, identifying genetic associations with outcomes is essential. However, not all patients invited to participate in such studies agree. While existing data suggests race, gender, and education may influence this decision, correlates of patient willingness to participate in genetic studies remain incompletely understood. We assessed correlates of patient participation in the genetic substudy of TRIUMPH, a prospective myocardial infarction registry ongoing at 26 US hospitals. Patients enrolled in the first wave (4/05–12/06, N=1854) were analyzed. Factors examined included sociodemographics, financial status, social support, medical literacy, health status, depressive symptoms (PHQ-9, higher scores indicate greater depression) and 26 clinical variables. Predictors of participation were identified using hierarchical logistic regression adjusting for hospital. Variation in consent rates across hospitals was quantified by the median odds ratio (MOR), which compares the odds of consent between two randomly selected patients with identical covariates chosen from different hospitals. Most subjects consented to donation and storage of their genetic material (1,513, 81.6%). Participation rates varied greatly by site, ranging from 50% to 100%. After adjustment for possible confounding by patient factors, the MOR for hospitals was 4.5. Clinical characteristics were not associated with participation in univariate analysis (all p>0.1). In multivariable analysis adjusted for hospital, the only significant predictors of consent were greater depressive symptoms (OR 1.41 per +5 PHQ points, 95% CI 1.19–1.67, p<0.0001), and gender (OR 1.54 for males, 95% CI 1.16–2.04, p=0.0027). Roughly 80% of subjects enrolled in our study consented to genetic analysis. The strongest overall factor associated with participation was hospital. While we cannot rule out confounding by unmeasured characteristics, this suggests that variation in the way information is presented, or other site-specific factors, strongly influence patient participation in genetic studies.
This research has received full or partial funding support from the American Heart Association, AHA Midwest Affiliate (Illinois, Indiana, Iowa, Kansas, Michigan, Minnesota, Missouri, Nebraska, North Dakota, South Dakota & Wisconsin).
Factors influencing patient willingness to participate in genetic research after a myocardial infarction
