Veterans Aging Cohort Study Site Evaluations Overview of 2005-2006 Site Visits & Future Evaluation Criteria Deborah. V. Gibson, MA Kristin Mattocks, PhD, MPH

General Overview of Site Visit The intent was to: Evaluate progress made to date Highlight areas that are working well Identify areas that could be improved and add to the continued success of the site.

General Overview of Site Visit Areas of evaluation: Proper storage of patient data (to ensure confidentiality): Assessment of management, documentation, and storage of consents, surveys, and payment receipts Interaction with the site over the past year, including: Participation in conference calls Timeliness of information submitted to the CC Site performance in FU Surveys, DNA/Blood Study, regulatory matters (IRB) & other substantive areas

Confidentiality of Patient Data

Analysis of 10 Randomly Selected Files

Site Participation & Communication (ID & GM included separately where needed)

Follow Up #3 Survey Performance

DNA / Blood Study Performance

Regulatory Performance

Summary of Findings Most sites performing very well with regard to enrollment, retention, shipment of paperwork to CC & Palo Alto, and regulatory (IRB) matters. Improvement in attention to details on Follow Up & DNA/Blood study paperwork would help reduce Coordinator & CC workload.

Future Evaluation Criteria Some evaluation metrics will remain the same, others will evolve as study evolves: Proper storage of patient documents Adherence to blood/DNA study protocols (including enrollment and documentation regarding refusal to participate in blood/DNA substudy) Enrollment protocols/standards (Fall 2007) Proper use of Cause of Death and HAART Naïve documentation Adherence to VA electronic security standards

Acknowledgements PI and Co-PI: AC Justice, DA Fiellin Participating VA Medical Centers: Atlanta (D. Rimland, C Jones-Taylor), Baltimore (KA Oursler, R Titanji), Bronx (S Brown, S Garrison), Houston (M Rodriguez-Barradas, N Masozera), Los Angeles (M Goetz, D Leaf), Manhattan-Brooklyn (M Simberkoff, D Blumenthal, J Leung), Pittsburgh (A Butt, E Hoffman), and Washington DC (C Gibert, R Peck) Core Faculty: S Braithwaite, C Brandt, K Bryant, R Cook, J Conigliaro, K Crothers, J Chang, S Crystal, N Day, J Erdos, M Freiberg, M Kozal, M Gaziano, M Gerschenson, B Good, A Gordon, J Goulet, M Hernan, K Kraemer, J Lim, S Maisto, K Mattocks, P Miller, L Mole, P O’Connor, R Papas, H Paek, J Robins, C Rinaldo, M Roberts, J Samet, B Tierney, J Whittle Staff: D Cohen, A Consorte, D Gibson, K Gordon, F Kidwai, F Levin, K McGinnis, M Rambo, J Rogers, M Skanderson, F Whitsett Major Collaborators: Immunology Case Registry, Pharmacy Benefits Management, Framingham Heart Study, Women’s Interagency HIV Study, Massachusetts Veterans Epidemiology Research and Information Center (MAVERIC), Health Economics Research Center (HERC), Center for Health Equity Research and Promotion (CHERP) Funded by: National Institute on Alcohol Abuse and Alcoholism (2U10 AA 13566); National Institute on Aging (K23 G00826); Robert Wood Johnson Generalist Faculty Scholar Award; an Inter-Agency Agreement between National Institute on Aging, National Institute of Mental Health, and the Veterans Health Administration; the VHA Office of Research and Development; and, VHA Public Health Strategic Health Care Group.