Objectives
To evaluate the reliability and cluster structure of the Pediatric Quality of Life Inventory Type 1 Diabetes Module 3.0 (PedsQL-T1DM) and associated subscales and to explore the associations between PedsQL-T1DM total score and demographic and clinical characteristics and clinical indicators among a large racially/ethnically diverse cohort of youth with type 1 diabetes.
Study design
Principal components analysis was conducted on responses from the PedsQL-T1DM child self-report forms completed by SEARCH for Diabetes in Youth study participants aged ≥5 years. Multivariate linear regression models were fit to examine the associations among PedsQL-T1DM total score, demographic and clinical characteristics, and clinical indicators.
Results
The sample comprised 2602 youth with a mean age of 13.6 ± 4.1 years and a mean T1DM duration of 62.1 ± 47.0 months. Principal components analysis did not support the 5 existing PedsQL-T1DM subscales. In multivariate analyses, the PedsQL-T1DM total score was negatively and significantly associated with younger age (5–7 years), female sex, receiving insulin by injection (vs pump), having parents without a college degree, Medic-aid/Medicare insurance, and having a comorbid medical condition. Youth with poor glycemic control based on their age-specific hemoglobin A1c target values and those with depressive symptoms had significantly lower PedsQL-T1DM scores than their counterparts with good control and no or limited depressive symptoms.
Conclusion
This study has identified sociodemographic and clinical characteristics of youth with T1DM more likely to experience poor diabetes-specific quality of life. The association of lower PedsQL-T1DM scores with depressive symptoms and poor glycemic control is especially concerning and may be the focus of future interventions and studies.
Recent attention to reducing health disparities among population groups has focused on the need to include in clinical studies, especially clinical trials, participants who represent the diversity of the populations to which study results will be applied. While scientists generally applaud the goal of broadening the characteristics of participants in clinical trials, they are faced with multiple challenges as they seek to include historically underrepresented populations in their research. This article examines the historical and sociocultural context of participation by underrepresented groups, especially women and minorities, in clinical trials, identifies major barriers and challenges facing researchers, and suggests strategies for meeting these challenges. The article draws upon the experiences of the investigators affiliated with the National Centers of Excellence of Women's Health (CoEs).
Background: We sought to determine if type 2 diabetes mellitus (T2DM) was associated with accelerated decline in domain-specific measures of cognitive function and fine motor speed. Methods: Women aged 65-80 years who were enrolled in a clinical trial of postmenopausal hormone therapy were grouped as having T2DM (n = 179) or not (n = 1984) and followed for an average of 5 years with annual standardized assessments of domain-specific cognitive function. Mean patterns of cognitive measures over time were contrasted between groups using general linear models and Wald tests, with varying levels of covariate adjustment. The influences of age at onset, use of oral medications, and use of insulin were also examined. Results: T2DM was associated with mean deficits of 0.2-0.4 standard deviations (SD) across follow-up in most cognitive domains. Consistent evidence that rates of decline were accelerated among women with T2DM was evident only for verbal knowledge and verbal memory ( p < 0.05). Decrements in fine motor speed, but no measure of cognitive function, were greater for women with earlier onset T2DM. Use of oral diabetes medications was associated with better relative cognitive function. Conclusions: In these women, T2DM was associated with cognitive deficits in most domains. Relative deficits in verbal knowledge and verbal memory may continue to increase after deficits in other domains have stabilized. Relative deficits in fine motor speed may be greater among women with earlier onsets of T2DM. Use of insulin, which may reflect greater T2DM severity, was associated with relatively greater cognitive deficits.
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