Takeaways
- First-born children, older maternal age, residence in Sweden, and high maternal satisfaction predict better compliance in a longitudinal study on pediatric subjects at risk for type 1 diabetes (T1D).
- Paternal participation is associated with improved study visit compliance.
- Predictors of substandard compliance include maternal smoking, post-partum depression, and anxiety about the child's diabetes risk.
- Ethnic-minority children are more likely to exhibit poor visit compliance.
- The findings offer valuable insights for future strategies to enhance study visit compliance in longitudinal pediatric studies, especially those focused on T1D risk.
Maternal characteristics, such as older age and study satisfaction, sociodemographic variables, and the father’s participation within the first year of a longitudinal study were associated with better visit compliance in a cohort of pediatric subjects genetically at risk for type 1 diabetes (T1D), according to a study published in European Journal of Medical Research.1
The islet autoantibodies and genetic profile associated with an increased risk of developing T1D, one of the most common autoimmune diseases in children, has been established. Although most at-risk children do not develop the condition, nearly all children who develop multiple islet autoantibodies will go on to be diagnosed with T1D.2
“To our knowledge this is the most comprehensive attempt to identify factors measured in year 1 of a longitudinal pediatric study that predict study visit compliance in the subsequent 3 years,” wrote Jessica Melin, PhD, associated with the Department of Clinical Science, Lund University, Sweden, and colleagues.
The Environmental Determinants of Diabetes in the Young (TEDDY) study is a longitudinal, multinational assessment of children at risk for T1D designed to identify the environmental triggers of islet autoimmunity and T1D. This analysis focused on sociodemographic variables, such as age, sex, birth status, maternal age, and family history of T1D, maternal reactions to the child’s risk of developing diabetes, as well as maternal lifestyle behaviors, including smoking and post-partum depression, in year 1 of the TEDDY study to predict study visit compliance in the subsequent 3 years. The link between these variables and study visit compliance was determined using multiple linear regression.
Visits consisted of 4 appointments per year until 4 years of age, followed by 2 per year until 15 years of age, and included interviews, food records, questionnaires, and blood and other samples. Blood samples tested for 3 islet autoantibodies: insulin, insulinoma-associated protein 2, and glutamic acid decarboxylase.
Eligible participants were still enrolled and active at child-age 48 months and excluded children who developed T1D-related autoantibodies before the age of 4. The analysis included 4600 families with children aged 3.5 months to 48 months, of which 60.5% (n = 2784) completed all 11 visits.
According to univariate analysis, the sex of the child and whether the mother was working outside of the home, was a single parent, or believed the child’s risk could be reduced were unrelated to missed visits.
The multivariate model revealed study visit compliance was the highest in first born children (P >.001), those whose mothers were older (P >.001), those who resided in Sweden (P >.001), and for those whose mothers were more satisfied with the initial 1-year TEDDY study (P >.001). Sixty-five percent of mothers with the highest study satisfaction (scores of 5 or 6) completed all study visits compared with 48% of least satisfied mothers (scores of 0 – 2). Paternal participation was also linked to better compliance (P >.001). Although the father’s study satisfaction also predicted study visit compliance (P = .029), it was not deemed statistically significant in models including maternal satisfaction.
Predictors of substandard compliance included mothers who smoke (P >.001), experienced post-partum depression (P = .034), and reported anxiety about their child’s risk of developing diabetes (P = .002). Ethnic-minority children were also more likely to have poor visit compliance (P = .049).
Investigators noted the study was limited by including only children up to 4 years of age. Additionally, findings may be less applicable to studies with less demanding research protocols.
“This information can contribute to future strategies designed to improve study visit compliance in longitudinal pediatric studies,” investigators concluded.
References:
- Melin J, Lynch KF, Lundgren M, Aronsson CA, Larsson HE, Johnson SB. Factors assessed in the first year of a longitudinal study predict subsequent study visit compliance: the TEDDY study. Eur J Med Res. 2023;28(1):592. Published 2023 Dec 15. doi:10.1186/s40001-023-01563-z
- Besser REJ, Bell KJ, Couper JJ, Ziegler AG, Wherrett DK, Knip M, et al. ISPAD clinical practice consensus guidelines 2022: stages of type 1 diabetes in children and adolescents. Pediatr Diabetes. 2022. https://doi.org/10.1111/pedi.13410.
This article was initially published by our sister publication, HCP Live.
