OBJECTIVE: Our objective was to identify characteristics of @entity1 and their families who were enrolled, refused to enroll, or were excluded from The Environmental Determinants of @entity6 in the Young (TEDDY) study. METHOD: 16,435 @entity1 screened at birth and identified as at increased genetic risk for type 1 @entity6 (T1DM) were placed into one of three categories: enrolled, excluded, or refused to enroll. Enrollment, exclusion and refusal rates were compared across countries and between @entity1 from the general population (GP) and @entity1 with a first degree T1DM relative (FDR). A multivariate logistic model was used to identify factors associated with TEDDY enrollment. RESULTS: TEDDY enrollment, exclusion, and refusal rates differed by country and by GP/FDR status but reasons for refusal to enroll were similar across countries and GP/FDR populations. Sweden had the highest enrollment rate, US had the highest exclusion rate, and Finland had the highest refusal rate. FDR @entity1 were more likely to enroll than GP @entity1 . Inability to re-contact the family was the most common reason for exclusion. Primary reasons for refusal to enroll included protocol factors (e.g. blood draws) or family factors (e.g., too busy). Study enrollment was associated with FDR status, European country of origin, older maternal age, a singleton birth, and having another @entity1 in TEDDY. CONCLUSIONS: Findings highlight the importance of country specific estimates for enrollment targets in longitudinal pediatric studies and suggest that enrollment estimates should be lowered when the study involves the general population, painful procedures, or makes multiple demands on families.

Enrollment experiences in a pediatric longitudinal observational study: The Environmental Determinants of XXXX in the Young (TEDDY) study.

@entity1 :: ('9606', 'Species') :: ['child', 'infants'] @entity6 :: ('MESH:D003920', 'Disease') :: ['Diabetes', 'diabetes']
@entity6 :: (MESH:D003920,Disease) :: ['Diabetes']
