University of Colorado Denver, The Barbara Davis Center for Childhood Diabetes 1775 Aurora Court, Campus Box F-527, Aurora, CO 80045, United States.
Contemp Clin Trials. 2012 Mar;33(2):273-8. doi: 10.1016/j.cct.2011.11.010. Epub 2011 Nov 12.
The Environmental Determinants of Diabetes in the Young (TEDDY), a multinational epidemiological study, is designed to identify environmental exposures triggering autoimmunity and type 1 diabetes (T1D) in children at increased genetic risk. The objective of this analysis was to evaluate the use of an informational video in the enrollment and retention of eligible participants at the Colorado TEDDY clinical center.
Eligible participants were divided into two groups based on the inclusion of the video in the enrollment materials: the No-Video Group (n=449) did not receive the video and were contacted between 7/1/07 and 6/30/08. The Video Group (n=494) received the video and were contacted between 7/1/08 and 6/30/09. Multiple logistic regression compared the enrollment rates (percent of eligible subjects deciding to enroll) of those who received the video compared to those who did not. Kaplan-Meier survival analysis and a multivariate Cox proportional hazards model compared the differences in study retention, as defined by active participation fifteen months after the baseline visit at three months of age.
Both groups were demographically similar. The enrollment rate was significantly higher for the Video Group (56.9%) compared to the No-Video Group (49.9%). Differences remained significant with adjustment for other known factors. A difference in retention between the two groups was not observed.
Methods and materials increasing understanding and more accurately informing participants of what is involved in participation may increase enrollment in a prospective observational study.
儿童糖尿病环境决定因素（TEDDY）是一项多国流行病学研究，旨在确定增加遗传风险的儿童中引发自身免疫和 1 型糖尿病（T1D）的环境暴露。本分析的目的是评估在科罗拉多 TEDDY 临床中心，使用信息视频招募和保留合格参与者的效果。
根据纳入视频的情况，将合格参与者分为两组：无视频组（n=449）未收到视频，联系时间为 2007 年 7 月 1 日至 2008 年 6 月 30 日。视频组（n=494）收到视频，并于 2008 年 7 月 1 日至 2009 年 6 月 30 日期间联系。多因素逻辑回归比较了收到视频与未收到视频的参与者的入组率（决定入组的合格受试者百分比）。Kaplan-Meier 生存分析和多变量 Cox 比例风险模型比较了两组在三个月大时的基线访问后十五个月的研究保留率差异，定义为积极参与。
两组在人口统计学上相似。视频组的入组率（56.9%）明显高于无视频组（49.9%）。在调整其他已知因素后，差异仍然显著。两组之间的保留率差异无统计学意义。
增加对参与者的理解并更准确地告知他们参与的情况的方法和材料可能会增加前瞻性观察性研究的入组率。
