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Lernmark, B.* ; Lynch, K.* ; Baxter, J.* ; Roth, R. ; Simell, T.* ; Smith, L.* ; Swartling, U.* ; Johnson, S.B.* ; TEDDY Study Group (Ziegler, A.-G. ; Beyerlein, A. ; Bonifacio, E. ; Hummel, M. ; Hummel, S. ; Knopff, A. ; Peplow, C. ; Stock, J. ; Strauss, E. ; Warncke, K. ; Winkler, C.)

Participant experiences in The Environmental Determinants of Diabetes in the Young study: Common reasons for withdrawing.

J. Diabetes Res. 2016:2720650 (2016)
Publ. Version/Full Text DOI PMC
Open Access Gold
Creative Commons Lizenzvertrag
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.
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Publication type Article: Journal article
Document type Scientific Article
Corresponding Author
Keywords Intervention; Predictors; Teddy; Completion; Attrition; Children; Program; Trial; Risk; Pain
ISSN (print) / ISBN 2314-6753
e-ISSN 2314-6745
Journal Journal of Diabetes Research
Quellenangaben Volume: 2016, Issue: , Pages: , Article Number: 2720650 Supplement: ,
Publisher Hindawi
Publishing Place New York, NY [u.a.]
Non-patent literature Publications
Reviewing status Peer reviewed
Institute(s) Institute of Diabetes Research Type 1 (IDF)