Document Detail


Enrollment experiences in a pediatric longitudinal observational study: The Environmental Determinants of Diabetes in the Young (TEDDY) study.
MedLine Citation:
PMID:  21419878     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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.
Authors:
Barbro Lernmark; Suzanne Bennett Johnson; Kendra Vehik; Laura Smith; Lori Ballard; Judy Baxter; Wendy McLeod; Roswith Roth; Tuula Simell
Related Documents :
21402638 - Increased odds of necrotizing enterocolitis after transfusion of red blood cells in pre...
16927878 - Effect of commiphora molmol on bithynia connollyi with special reference to their morph...
9215328 - Deaths caused by bedrails.
23889768 - Cpap titration in infants with severe upper airway obstruction or bronchopulmonary dysp...
539408 - A prospective study of cow's milk protein intolerance in swedish infants.
19196208 - Statistical model predicting a short duration to birth in women with preterm labor at 2...
Publication Detail:
Type:  Journal Article; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't; Research Support, U.S. Gov't, P.H.S.     Date:  2011-03-17
Journal Detail:
Title:  Contemporary clinical trials     Volume:  32     ISSN:  1559-2030     ISO Abbreviation:  Contemp Clin Trials     Publication Date:  2011 Jul 
Date Detail:
Created Date:  2011-05-30     Completed Date:  2011-11-08     Revised Date:  2014-06-02    
Medline Journal Info:
Nlm Unique ID:  101242342     Medline TA:  Contemp Clin Trials     Country:  United States    
Other Details:
Languages:  eng     Pagination:  517-23     Citation Subset:  IM    
Copyright Information:
Copyright © 2011 Elsevier Inc. All rights reserved.
Export Citation:
APA/MLA Format     Download EndNote     Download BibTex
MeSH Terms
Descriptor/Qualifier:
Diabetes Mellitus, Type 1 / etiology*
Environment
Europe
Female
Humans
Infant, Newborn
Logistic Models
Longitudinal Studies
Male
Multivariate Analysis
Neonatal Screening
Observation
Patient Selection*
Refusal to Participate / statistics & numerical data*
United States
Grant Support
ID/Acronym/Agency:
63790//PHS HHS; 63821//PHS HHS; 63829//PHS HHS; 63836//PHS HHS; 63861//PHS HHS; 63863//PHS HHS; 63865//PHS HHS; U01 DK063861-09/DK/NIDDK NIH HHS; UC4 DK063861/DK/NIDDK NIH HHS
Comments/Corrections

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


Previous Document:  Upconversion nanoparticles: synthesis, surface modification and biological applications.
Next Document:  Resolving the question of trypanosome monophyly: a comparative genomics approach using whole genome ...