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

Lernmark, Barbro LU ; Johnson, Suzanne Bennett; Vehik, Kendra; Smith, Laura; Ballard, Lori; Baxter, Judy; McLeod, Wendy; Roth, Roswith and Simell, Tuula (2011) In Contemporary Clinical Trials 32. p.517-523
Abstract
OBJECTIVE: Our objective was to identify characteristics of infants and their families who were enrolled, refused to enroll, or were excluded from The Environmental Determinants of Diabetes in the Young (TEDDY) study. METHOD: 16,435 infants screened at birth and identified as at increased genetic risk for type 1 diabetes (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 infants from the general population (GP) and infants 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... (More)
OBJECTIVE: Our objective was to identify characteristics of infants and their families who were enrolled, refused to enroll, or were excluded from The Environmental Determinants of Diabetes in the Young (TEDDY) study. METHOD: 16,435 infants screened at birth and identified as at increased genetic risk for type 1 diabetes (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 infants from the general population (GP) and infants 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 infants were more likely to enroll than GP infants. 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 child 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. (Less)
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author
organization
publishing date
type
Contribution to journal
publication status
published
subject
in
Contemporary Clinical Trials
volume
32
pages
517 - 523
publisher
Elsevier
external identifiers
  • wos:000292226500009
  • pmid:21419878
  • scopus:79957478870
ISSN
1551-7144
DOI
10.1016/j.cct.2011.03.009
language
English
LU publication?
yes
id
00142689-6e57-401e-92aa-d322e13b67fc (old id 1883705)
alternative location
http://www.ncbi.nlm.nih.gov/pubmed/21419878?dopt=Abstract
date added to LUP
2011-04-01 17:09:19
date last changed
2017-10-01 04:58:45
@article{00142689-6e57-401e-92aa-d322e13b67fc,
  abstract     = {OBJECTIVE: Our objective was to identify characteristics of infants and their families who were enrolled, refused to enroll, or were excluded from The Environmental Determinants of Diabetes in the Young (TEDDY) study. METHOD: 16,435 infants screened at birth and identified as at increased genetic risk for type 1 diabetes (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 infants from the general population (GP) and infants 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 infants were more likely to enroll than GP infants. 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 child 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.},
  author       = {Lernmark, Barbro and Johnson, Suzanne Bennett and Vehik, Kendra and Smith, Laura and Ballard, Lori and Baxter, Judy and McLeod, Wendy and Roth, Roswith and Simell, Tuula},
  issn         = {1551-7144},
  language     = {eng},
  pages        = {517--523},
  publisher    = {Elsevier},
  series       = {Contemporary Clinical Trials},
  title        = {Enrollment experiences in a pediatric longitudinal observational study: The Environmental Determinants of Diabetes in the Young (TEDDY) study.},
  url          = {http://dx.doi.org/10.1016/j.cct.2011.03.009},
  volume       = {32},
  year         = {2011},
}