Publications by authors named "T J Coffman"

Background: The interactive media-based approach to community consultation and public disclosure (CC/PD), a key step when conducting exception from informed consent (EFIC) clinical trials, is intended to be completed in 4 months. This analysis characterizes the process, from initiation of CC/PD activities to institutional review board approval, to better understand the barriers and how these can be mitigated.

Methods: This is a retrospective post hoc analysis of data collected as part of the CC/PD campaigns conducted for a large trial involving up to 90 trauma centers in the United States.

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Patients with gastric cancer experience symptoms that impact adequate nutritional intake. Delayed diagnosis may result in advanced disease. Surgery, chemotherapy, biologic therapy, and radiotherapy comprise interventions.

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Article Synopsis
  • The study investigates how plasma metabolites are linked to the progression of chronic kidney disease in individuals with type 2 diabetes, focusing on kidney function decline measured by eGFR slope.
  • Researchers analyzed data from over 5,000 people, identifying specific elevated levels of lipids and amino acids that influence kidney function, both positively and negatively.
  • The findings suggest that metabolite abnormalities, particularly related to fatty acids, may indicate issues with fat breakdown and are connected to the risk of worsening kidney health in diabetic patients.
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Aim: Among multi-ethnic Asians, type 2 diabetes (T2D) clustered in three subtypes; mild obesity-related diabetes (MOD), mild age-related diabetes with insulin insufficiency (MARD-II) and severe insulin-resistant diabetes with relative insulin insufficiency (SIRD-RII) had differential cardio-renal complication risk. We assessed the proteomic profiles to identify subtype specific biomarkers and its association with diabetes complications.

Methods: 1448 plasma proteins at baseline were measured and compared across the T2D subtypes.

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Importance: Exception From Informed Consent (EFIC) research requires community consultation (CC) and public disclosure (PD). Traditional methods of conducting CC and PD are slow, expensive, and labor intensive.

Objective: To describe the feasibility and reach of a novel interactive, media-based approach to CC and PD and to identify the similarities and differences between trial sites in website views, survey responses, online community forum attendance, and opt-out requests.

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