Objective This study evaluated the distinctive clinical and biological manifestations of depressive symptom subtypes (i.e., cognitive–affective and somatic) in Veterans with hepatitis C viral infection (HCV) before and during interferon-alpha (IFN) based antiviral therapy. Methods Thirty-two Veterans with HCV and no prior history of IFN therapy were followed prospectively during the first 16 weeks of therapy to evaluate depressive symptoms and to determine if baseline cytokine and serotonin levels predicted subsequent changes in depressive scores. Results IFN therapy resulted in a significant increase in total depressive symptoms from baseline (week 0) to week 16, with neurovegetative and somatic symptoms of depression including loss of appetite, fatigue and irritability increasing within the first two weeks of therapy and continuing to increase throughout IFN therapy. When depressive symptoms were evaluated using a two-factor (i.e., Cognitive–Affective and Somatic) model, the Cognitive–Affective factor score did not change significantly following IFN therapy initiation, while the Somatic factor score showed a significant increase from week 0 to week 16. Veterans with the largest increases in somatic symptoms from week 0 to week 2 had significantly higher levels of tumor necrosis factor-alpha (TNF-α) and lower levels of serotonin at baseline, as compared to Veterans with minimal or no increase in somatic symptoms. Conclusion Somatic symptoms of depression can be significantly exacerbated during IFN therapy and may be predicted by higher TNF-α levels and lower serotonin levels at baseline.

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BackgroundRecruitment into clinical trials remains a key determinant to study completion and success. While various strategies have been proposed, it is unclear how they apply across different populations, diseases, and/or study goals. The ability to effectively overcome challenges may require different approaches that more broadly focus on addressing obstacles among sites that cannot be overcome by individual studies.MethodsThe Department of Veterans Affairs (VA) Cooperative Studies Program (CSP) established the Network of Dedicated Enrollment Sites (NODES) as a consortium of sites to generate systematic site-level solutions to more efficiently recruit in CSP studies. Initial activities identified priorities and developed approaches through team-based efforts. Metrics were also developed to assess overall network performance.ResultsNetwork efforts produced several new strategies and best practices for common problems in CSP research. Recruitment strategies included bringing studies to patients and developing data programs using algorithms for finding eligible patients. Efficiency efforts focused on cross-training and standardizing performance reports.ConclusionNODES addressed site challenges in clinical trial recruitment and management by taking an overall approach that looked at the system rather than individual studies. Practices and operational changes were implemented for CSP research related to recruitment, staff training and research methodology. The network activities suggest that team-based development of tools and insights may help better identify targets and increase efficiencies for clinical trials recruitment.

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