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Participant Experiences in the Environmental Determinants of Diabetes in the Young Study: Common Reasons for Withdrawing.

Lernmark, Barbro LU ; Lynch, Kristian; Baxter, Judith; Roth, Roswith; Simell, Tuula; Smith, Laura; Swartling, Ulrica LU ; Johnson, Suzanne Bennett and Teddy Study Group, NN (2016) In Journal of Diabetes Research 2016.
Abstract
Background. To characterize participant reasons for withdrawing from a diabetes focused longitudinal clinical observational trial (TEDDY) during the first three study years. Methods. 8677 children were recruited into the TEDDY study. At participant withdrawal staff recorded any reason parents provided for withdrawal. Reasons were categorized into (1) family characteristics and (2) protocol reasons. Families who informed staff of their withdrawal were classified as active withdrawals (AW); families without a final contact were considered passive withdrawals (PW). Results. Withdrawal was highest during the first study year (n = 1220). Most families were AW (n = 1549; 73.4%). PW was more common in the United States (n = 1001; 37.8%) and among... (More)
Background. To characterize participant reasons for withdrawing from a diabetes focused longitudinal clinical observational trial (TEDDY) during the first three study years. Methods. 8677 children were recruited into the TEDDY study. At participant withdrawal staff recorded any reason parents provided for withdrawal. Reasons were categorized into (1) family characteristics and (2) protocol reasons. Families who informed staff of their withdrawal were classified as active withdrawals (AW); families without a final contact were considered passive withdrawals (PW). Results. Withdrawal was highest during the first study year (n = 1220). Most families were AW (n = 1549; 73.4%). PW was more common in the United States (n = 1001; 37.8%) and among young mothers (p = 0.001). The most frequent protocol characteristic was blood draw (55%) and the most common family reason was not having enough time (66%). The blood draw was more common among female participants; being too busy was more common among males. Both reasons were associated with study satisfaction. Conclusions. Results suggest that, for families of children genetically at risk for diabetes, procedures that can be painful/frightening should be used with caution. Study procedures must also be considered for the demands placed on participants. Study satisfaction should be regularly assessed as an indicator of risk for withdrawal. (Less)
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author
organization
publishing date
type
Contribution to journal
publication status
published
subject
in
Journal of Diabetes Research
volume
2016
publisher
Hindawi Publishing Corporation
external identifiers
  • pmid:26682228
  • scopus:84949255927
  • wos:000370250700001
ISSN
2314-6753
DOI
10.1155/2016/2720650
language
English
LU publication?
yes
id
e49577af-0b78-4114-abcb-3f70a180cfb8 (old id 8504312)
alternative location
http://www.ncbi.nlm.nih.gov/pubmed/26682228?dopt=Abstract
date added to LUP
2016-01-12 12:32:55
date last changed
2017-07-02 04:33:02
@article{e49577af-0b78-4114-abcb-3f70a180cfb8,
  abstract     = {Background. To characterize participant reasons for withdrawing from a diabetes focused longitudinal clinical observational trial (TEDDY) during the first three study years. Methods. 8677 children were recruited into the TEDDY study. At participant withdrawal staff recorded any reason parents provided for withdrawal. Reasons were categorized into (1) family characteristics and (2) protocol reasons. Families who informed staff of their withdrawal were classified as active withdrawals (AW); families without a final contact were considered passive withdrawals (PW). Results. Withdrawal was highest during the first study year (n = 1220). Most families were AW (n = 1549; 73.4%). PW was more common in the United States (n = 1001; 37.8%) and among young mothers (p = 0.001). The most frequent protocol characteristic was blood draw (55%) and the most common family reason was not having enough time (66%). The blood draw was more common among female participants; being too busy was more common among males. Both reasons were associated with study satisfaction. Conclusions. Results suggest that, for families of children genetically at risk for diabetes, procedures that can be painful/frightening should be used with caution. Study procedures must also be considered for the demands placed on participants. Study satisfaction should be regularly assessed as an indicator of risk for withdrawal.},
  articleno    = {2720650},
  author       = {Lernmark, Barbro and Lynch, Kristian and Baxter, Judith and Roth, Roswith and Simell, Tuula and Smith, Laura and Swartling, Ulrica and Johnson, Suzanne Bennett and Teddy Study Group, NN},
  issn         = {2314-6753},
  language     = {eng},
  publisher    = {Hindawi Publishing Corporation},
  series       = {Journal of Diabetes Research},
  title        = {Participant Experiences in the Environmental Determinants of Diabetes in the Young Study: Common Reasons for Withdrawing.},
  url          = {http://dx.doi.org/10.1155/2016/2720650},
  volume       = {2016},
  year         = {2016},
}