Henry Ford Hospital, Heart and Vascular Institute, Detroit, Michigan, 48202, USA.
Genome Med. 2011 Jun 15;3(6):39. doi: 10.1186/gm255.
Achieving 'personalized medicine' requires enrolling representative cohorts into genetic studies, but patient self-selection may introduce bias. We sought to identify characteristics associated with genetic consent in a myocardial infarction (MI) registry.
We assessed correlates of participation in the genetic sub-study of TRIUMPH, a prospective MI registry (n = 4,340) from 24 US hospitals between April 2005 and December 2008. Factors examined included extensive socio-demographics factors, clinical variables, and study site. Predictors of consent were identified using hierarchical modified Poisson regression, adjusting for study site. Variation in consent rates across hospitals were quantified by the median rate ratio (MRR).
Most subjects consented to donation of their genetic material (n = 3,484; 80%). Participation rates varied greatly between sites, from 40% to 100%. After adjustment for confounding factors, the MRR for hospital was 1.22 (95% confidence interval (CI) 1.11 to 1.29). The only patient-level factors associated with consent were race (RR 0.93 for African Americans versus whites, 95% CI 0.88 to 0.99) and body mass index (RR 1.03 for BMI ≥ 25, 95% CI 1.01 to 1.06).
Among patients with an MI there were notable differences in genetic consent by study site, but little association with patient-level factors. This suggests that variation in the way information is presented during recruitment, or other site factors, strongly influence patients' decision to participate in genetic studies.
实现“个性化医疗”需要将有代表性的队列纳入遗传研究，但患者的自我选择可能会引入偏差。我们试图确定与心肌梗死（MI）注册研究中的遗传同意相关的特征。
我们评估了 2005 年 4 月至 2008 年 12 月期间，来自美国 24 家医院的 TRIUMPH 前瞻性 MI 注册研究（n = 4340）中遗传子研究的参与者的相关性。检查的因素包括广泛的社会人口统计学因素、临床变量和研究地点。使用分层修正泊松回归来确定同意的预测因素，并调整研究地点。通过中位数率比（MRR）量化医院之间同意率的差异。
大多数受试者同意捐赠他们的遗传物质（n = 3484；80%）。参与率在各医院之间差异很大，从 40%到 100%。在调整混杂因素后，医院的 MRR 为 1.22（95%置信区间（CI）1.11 至 1.29）。与同意相关的唯一患者层面因素是种族（非裔美国人的 RR 为 0.93，白人的 RR 为 0.93，95%CI 为 0.88 至 0.99）和体重指数（RR 为 1.03，BMI≥25 的 RR 为 1.03，95%CI 为 1.01 至 1.06）。
在 MI 患者中，研究地点之间在遗传同意方面存在显著差异，但与患者层面的因素关联不大。这表明，在招募过程中信息呈现方式的差异或其他地点因素强烈影响患者参与遗传研究的决策。
