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

被引:30
作者
Lernmark, Barbro [1 ]
Johnson, Suzanne Bennett [2 ]
Vehik, Kendra [3 ]
Smith, Laura [4 ]
Ballard, Lori [3 ]
Baxter, Judy [5 ]
McLeod, Wendy [3 ]
Roth, Roswith [6 ]
Simell, Tuula [7 ]
机构
[1] Lund Univ, Dept Clin Sci, CRC 72 60 11, Skane Univ Hosp, S-20502 Malmo, Sweden
[2] Florida State Univ, Coll Med, Dept Med Humanities & Social Sci, Tallahassee, FL 32306 USA
[3] Univ S Florida, Pediat Epidemiol Ctr, Tampa, FL 33612 USA
[4] Univ S Florida, Dept Pediat, Tampa, FL 33612 USA
[5] Univ Colorado Denver AMC, Sch Med, Barbara Davis Ctr Childhood Diabet, Aurora, CO 80045 USA
[6] Graz Univ, Inst Psychol, A-8010 Graz, Austria
[7] Univ Turku, Dept Pediat, FIN-20520 Turku, Finland
关键词
Enrollment; Recruitment; Natural history; Diabetes mellitus; Type; 1; diabetes;
D O I
10.1016/j.cct.2011.03.009
中图分类号
R-3 [医学研究方法]; R3 [基础医学];
学科分类号
1001 ;
摘要
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 recontact 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. (C) 2011 Elsevier Inc. All rights reserved.
引用
收藏
页码:517 / 523
页数:7
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