Department of Medical Humanities and Social Sciences, Florida State University College of Medicine, Tallahassee, FL 32306-4300, USA.
Pediatr Diabetes. 2011 May;12(3 Pt 1):165-71. doi: 10.1111/j.1399-5448.2010.00686.x. Epub 2010 Oct 28.
The Environmental Determinants of Diabetes in the Young (TEDDY) study seeks to identify environmental triggers of autoimmunity and type 1 diabetes mellitus (T1DM) in children at increased human-leukocyte-antigen conferred genetic risk for this disease. The objective of this study was to identify predictors of early withdrawal from TEDDY among families with no immediate family history of T1DM.
Logistic multiple regression was used to discriminate 2994 (83%) families currently active in the TEDDY study for ≥1 yr from 763 (17%) families who withdrew in the first year. Data collected on the screening form at the time of the child's birth and from interview and questionnaire data obtained at the baby's first study visit (at ≤4.5 months of age) were used.
Significant and independent predictors of early withdrawal included country of residence, young maternal age, no father participation, and female gender of the study participant. Mothers of children who withdrew were more likely to report smoking during pregnancy, abstaining from alcohol, and reducing their work hours or not working at all during pregnancy. Mothers who withdrew were also more likely to underestimate their child's risk for T1DM and fail to respond to multiple items on the enrollment questionnaires or interview. Among mothers with accurate risk perceptions, those experiencing high anxiety about their child's risk were more likely to be early withdrawals.
Identifying families at high risk for study withdrawal at the time of enrollment allows for targeting these families with individually tailored plans to help maintain their participation in the study.
儿童期糖尿病的环境决定因素(TEDDY)研究旨在确定在具有这种疾病高遗传风险的人类白细胞抗原(HLA)的儿童中,环境触发自身免疫和 1 型糖尿病(T1DM)的因素。本研究的目的是确定在没有 T1DM 家族史的家庭中,TEDDY 研究中早期退出的预测因素。
使用逻辑多元回归分析来区分目前在 TEDDY 研究中活跃≥1 年的 2994 个(83%)家庭和在第一年退出的 763 个(17%)家庭。在孩子出生时的筛查表上收集的数据,以及在孩子第一次研究访问时(≤4.5 个月大)获得的访谈和问卷调查数据,都被用于分析。
早期退出的显著且独立预测因素包括居住国家、母亲年龄较小、父亲不参与、以及研究参与者的女性性别。退出的孩子的母亲更有可能在怀孕期间吸烟、不饮酒、减少工作时间或完全不工作。退出的母亲也更有可能低估其孩子患 T1DM 的风险,并且无法对登记问卷或访谈中的多个项目做出回应。在风险认知准确的母亲中,那些对孩子的风险感到高度焦虑的母亲更有可能是早期退出者。
在登记时识别出有研究退出高风险的家庭,可以针对这些家庭制定个性化的计划,以帮助他们继续参与研究。