Enrollment experiences in a pediatric longitudinal observational study: The Environmental Determinants of Diabetes in the Young (TEDDY) study.
Enrollment experiences in a pediatric longitudinal observational study: The Environmental Determinants of Diabetes in the Young (TEDDY) study.
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DOI：
10.1016/j.cct.2011.03.009
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发表时间：
2011-07
影响因子：
2.2
通讯作者：
Simell T
中科院分区：
文献类型：
--
作者：
Lernmark B;Johnson SB;Vehik K;Smith L;Ballard L;Baxter J;McLeod W;Roth R;Simell T
我们的目的是确定参加、拒绝参加或被排除在年轻人糖尿病环境决定因素（TEDDY）研究之外的婴儿及其家庭的特征。16，435名婴儿在出生时接受筛查，并被确定为1型糖尿病（T1 DM）遗传风险增加，被分为三类：入选，排除或拒绝入选。比较了不同国家和一般人群（GP）婴儿与一级T1 DM亲属（FDR）婴儿的入组率、排除率和拒绝率。多变量logistic模型用于确定与TEDDY入组相关的因素。TEDDY入组、排除和拒绝率因国家和GP/FDR状态而异，但拒绝入组的原因在国家和GP/FDR人群中相似。瑞典的入学率最高，美国的排斥率最高，芬兰的拒绝率最高。FDR婴儿比GP婴儿更有可能入组。无法与家人重新联系是被排除在外的最常见原因。拒绝入组的主要原因包括方案因素（例如抽血）或家庭因素（例如，太忙碌）。研究入组与FDR状态、欧洲原籍国、高龄产妇年龄、单胎分娩和在TEDDY中有另一个孩子相关。研究结果强调了在纵向儿科研究中对招募目标进行国家特定估计的重要性，并建议当研究涉及一般人群、痛苦的程序或对家庭提出多种要求时，应降低招募估计。
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. 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. 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. 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.
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