The Environmental Determinants of Diabetes in the Young (TEDDY) Study: predictors of early study withdrawal among participants with no family history of type 1 diabetes

Abstract

Objective-The Environmental Determinants of Diabetes in the Young (TEDDY) study seeks to identify environmental triggers of autoimmunity and type 1 diabetes (T1DM) in children at increased HLA-conferred genetic risk for this disease. This study's objective was to identify predictors of early withdrawal from TEDDY among families with no immediate family history of T1DM.Method-Logistic multiple regression was used to discriminate 2994 (83%) families currently active in the TEDDY study for ≥ 1 year from 763 (17%) 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.Results-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. Study demands on TEDDY families are considerable and include blood draws, stool sample collections, diet records, interviews, and questionnaires. The participating infants are examined every three months until four years of age and every six months thereafter. Since TEDDY participation is both time-consuming and expensive for the families, the investigators and the funders, any loss of these valuable participants diminishes the power of the study to meet its objectivesIn this report, we describe family characteristics identified at study inception that predicted study withdrawal among general population families during the first year of the TEDDY study. This information may guide future efforts to retain families in studies like TEDDY and should prove useful in the design of future natural history epidemiological studies with pediatric populations. MethodsThe TEDDY study TEDDY is a natural history study that seeks to identify the environmental triggers of autoimmunity and T1DM onset in genetically at-risk children identified at three centers in the United States (Colorado, Washington, and Georgia/Florida) and three centers in Europe (Finland, Germany, and Sweden). Infants from the general population, as well as infants who have first degree relatives (FDR) with T1DM, are screened for genetic risk at birth using HLA genotyping. Parents with infants at increased genetic risk for T1DM are invited to participate in TEDDY. Parents are fully informed of the child's increased genetic risk and the protocol requirements of the TEDDY study, including the requirement that eligible infants must join TEDDY before the infant...

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“…More educated mothers with accurate perceptions of their child's T1DM risk, who had been in the TEDDY study longer and who rarely -if ever -missed a TEDDY visit, were more likely to return the questionnaire. We previously reported that mothers who accurately estimate their child's risk for TIDM are more likely to stay in the TEDDY study during the first year [10], a finding that is consistent with the current study's finding that mothers with accurate TDIM risk perceptions were more likely to return the questionnaire. Because more committed families were more likely to return the survey, the results are likely biased and represent the opinions of those most involved in the TEDDY study.…”

Respiratory infections are temporally associated with initiation of type 1 diabetes autoimmunity: the TEDDY study

“…Selection bias is likely as age of mother, country, education and other factors were associated with dropout rate in the TEDDY study [34, 35]. Misclassification of infections, as discussed for enterovirus infections, was an important limitation.…”

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