title: Participant Experiences in the Environmental Determinants of Diabetes in the Young Study: Common Reasons for Withdrawing.
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.
authors.affiliation: Department of Clinical Sciences, Lund University, CRC, Jan Waldenströms Gata 35, Skåne University Hospital (SUS), 20502 Malmö, Sweden.
authors.forename: Barbro
authors.initials: B
authors.lastname: Lernmark
authors.affiliation: Health Informatics Institute, University of South Florida, 3650 Spectrum Boulevard, Suite 100, Tampa, FL 33612, USA.
authors.forename: Kristian
authors.initials: K
authors.lastname: Lynch
authors.affiliation: Barbara Davis Center for Childhood Diabetes, School of Medicine, University of Colorado Denver-AMC, 1775 Aurora Court, Aurora, CO 80045, USA ; Colorado School of Public Health, Department of Community and Behavioral Health, University of Colorado Denver-AMC, 13001 E. 17th Place, Aurora, CO 80045, USA.
authors.forename: Judith
authors.initials: J
authors.lastname: Baxter
authors.affiliation: Institute of Diabetes Research, Helmholtz Center Munich and Clinic on the right of Isar, Technical University Munich, Research Group Diabetes e.V., Ingolstaedter Landstrasse 1, 85764 Neuherberg, Germany.
authors.forename: Roswith
authors.initials: R
authors.lastname: Roth
authors.affiliation: Department of Pediatrics, University of Turku, Kiinamyllynkatu 4-8, 20100 Turku, Finland.
authors.forename: Tuula
authors.initials: T
authors.lastname: Simell
authors.affiliation: Health Informatics Institute, University of South Florida, 3650 Spectrum Boulevard, Suite 100, Tampa, FL 33612, USA.
authors.forename: Laura
authors.initials: L
authors.lastname: Smith
authors.affiliation: Department of Clinical Sciences, Lund University, CRC, Jan Waldenströms Gata 35, Skåne University Hospital (SUS), 20502 Malmö, Sweden.
authors.forename: Ulrica
authors.initials: U
authors.lastname: Swartling
authors.affiliation: Department of Medical Humanities and Social Sciences, Florida State University College of Medicine, 1115 West Call Street, Tallahassee, FL 32306, USA.
authors.forename: Suzanne Bennett
authors.initials: SB
authors.lastname: Johnson
authors.affiliation: Department of Clinical Sciences, Lund University, CRC, Jan Waldenströms Gata 35, Skåne University Hospital (SUS), 20502 Malmö, Sweden ; Health Informatics Institute, University of South Florida, 3650 Spectrum Boulevard, Suite 100, Tampa, FL 33612, USA ; Barbara Davis Center for Childhood Diabetes, School of Medicine, University of Colorado Denver-AMC, 1775 Aurora Court, Aurora, CO 80045, USA ; Institute of Diabetes Research, Helmholtz Center Munich and Clinic on the right of Isar, Technical University Munich, Research Group Diabetes e.V., Ingolstaedter Landstrasse 1, 85764 Neuherberg, Germany ; Department of Pediatrics, University of Turku, Kiinamyllynkatu 4-8, 20100 Turku, Finland ; Pacific Northwest Diabetes Research Institute, 720 Broadway, Seattle, WA 98122, USA ; Center for Biotechnology and Genomic Medicine, Medical College of Georgia, Georgia Regents University, 1120 15th Street, CA-4123, Augusta, GA 30912, USA.
mesh_terms: D001800:Blood Specimen Collection / Q000523:psychology*; D002675:Child, Preschool; D003922:Diabetes Mellitus, Type 1 / Q000097:blood / Q000209:etiology*; D018450:Disease Progression; D005260:Female; D006801:Humans; D007223:Infant; D008297:Male; D010352:Patient Dropouts / Q000523:psychology*; D012737:Sex Factors