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Implementation of genome-scale sequencing in clinical care has significant challenges: the technology is highly dimensional with many kinds of potential results, results interpretation and delivery require expertise and coordination across multiple medical specialties, clinical utility may be uncertain, and there may be broader familial or societal implications beyond the individual participant. Transdisciplinary consortia and collaborative team science are well poised to address these challenges. However, understanding the complex web of organizational, institutional, physical, environmental, technologic, and other political and societal factors that influence the effectiveness of consortia is understudied. We describe our experience working in the Clinical Sequencing Evidence-Generating Research (CSER) consortium, a multi-institutional translational genomics consortium.
A key aspect of the CSER consortium was the juxtaposition of site-specific measures with the need to identify consensus measures related to clinical utility and to create a core set of harmonized measures. During this harmonization process, we sought to minimize participant burden, accommodate project-specific choices, and use validated measures that allow data sharing.
Identifying platforms to ensure swift communication between teams and management of materials and data were essential to our harmonization efforts. Funding agencies can help consortia by clarifying key study design elements across projects during the proposal preparation phase and by providing a framework for data sharing data across participating projects.
In summary, time and resources must be devoted to developing and implementing collaborative practices as preparatory work at the beginning of project timelines to improve the effectiveness of research consortia.
Objectives: Good glycemic control is an important goal of diabetes management. Late adolescents with type 1 diabetes (T1D) are at risk for poor glycemic control as they move into young adulthood. For a subset of these patients, this dysregulation is extreme, placing them at risk for life-threatening health complications and permanent cognitive declines. The present study examined whether deficiency in emotional decision making (as measured by the Iowa Gambling Task; IGT) among teens with T1D may represent a neurocognitive risk factor for subsequent glycemic dysregulation. Methods: As part of a larger longitudinal study, a total of 241 high-school seniors (147 females, 94 males) diagnosed with T1D underwent baseline assessment that included the IGT. Glycated hemoglobin (HbA1c), which reflects glycemic control over the course of the past 2 to 3 months, was also assessed at baseline. Of the 241,189 (127 females, 62 males, mean age=17.76, mean HbA1c=8.11) completed HbA1c measurement 1 year later. Results: Baseline IGT performance in the impaired range (per norms) was associated with greater dysregulation in glycemic control 1 year later, as evidenced by an average increase in HbA1c of 2%. Those with normal IGT scores (per norms) exhibited a more moderate increase in glycemic control, with an HbA1c increase of 0.7%. Several IGT scoring approaches were compared, showing that the total scores collapsed across all trials was most sensitive to change in glycemic control. Conclusions: IGT assessment offers promise as a tool for identifying late adolescents at increased risk for glycemic dysregulation. (JINS, 2017, 23, 204–213)
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