Differences in recruitment and early retention among ethnic minority participants in a large pediatric cohort: the TEDDY Study

Contemp Clin Trials. 2012 Jul;33(4):633-40. doi: 10.1016/j.cct.2012.03.009. Epub 2012 Mar 29.

Abstract

Objective: The TEDDY Study is an international, multi-center prospective study designed to identify the environmental triggers of type 1 diabetes (T1D) in genetically at-risk children. This report investigates ethnic minority (EM) differences in patterns of enrollment and retention in the US centers.

Methods: As of June 2009, 267,739 newborns had been screened at birth for high risk T1D genotypes. Data collected at the time of screening, enrollment and at the baseline visit were used. Descriptive and multiple-logistic regression analyses assessed differences between EM groups regarding exclusion, enrollment and early withdrawal.

Results: Of the 10,975 eligible subjects, 6,912 (67%) were invited to participate. EM subjects were more likely to be excluded because of an inability to contact. Of those invited 3,265 (47%) enrolled by the age of 4.5 months. Adjusted analyses showed that except for those classified as other EM, the odds of enrolling were similar across groups. EM subjects had elevated early withdrawal rates. Adjusted models demonstrated that this was significantly more likely among Hispanic subjects.

Conclusion: Understanding patterns associated with EM participation in research extends our ability to make more accurate inferences and permits assessment of strategies that promote inclusion of EM to better address health disparities.

Publication types

  • Multicenter Study
  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Cohort Studies
  • Diabetes Mellitus, Type 1 / diagnosis
  • Diabetes Mellitus, Type 1 / ethnology
  • Diabetes Mellitus, Type 1 / etiology*
  • Female
  • Health Status Disparities
  • Humans
  • Infant
  • Infant, Newborn
  • Logistic Models
  • Lost to Follow-Up
  • Male
  • Minority Groups / statistics & numerical data*
  • Neonatal Screening
  • Patient Dropouts / statistics & numerical data*
  • Patient Selection*
  • Prospective Studies
  • United States