Clinical Outcomes Core
Director:
Ned Sacktor, MD
Associate Professor of Neurology
Co-Directors:
Ola Selnes, PhD
Professor of Neurology, Cognitive Neuroscience Division
John McGready, PhD
Associate Scientist, Department of Biostatistics
The Johns Hopkins Bloomberg School of Public Health
Co-Investigators:
Richard Skolasky, MA, ScD
Assistant Professor of Orthopedics
Richard Moore MD, MHSc
Professor of Medicine
Kelly Gebo MD, MPH
Assistant Professor of Medicine.

Goals and Objectives
The Clinical Outcomes Core will serve the following functions:

1. Pprovide the resources necessary to validate new, robust, and biologically valid outcome measures for epidemiological research and treatment trials in HIV-associated cognitive disorders.
2. Develop new instruments that will integrate measurements of medication adherence and cognition.
3. Provide validated test batteries critical for rapid development of clinical trials of novel therapeutic agents for the treatment of HIV dementia.
4. Develop a logical data infrastructure across multicenter modalities to allow efficient querying of clinical and laboratory data.
5. Develop and apply appropriate statistical and epidemiological methods to support studies involving the Center Grant resources.
6. Provide a resource for and linkage with ongoing Neuro-AIDS trial consortia including the Neurological AIDS Research Consortium (NARC, PI-Dr. David Clifford), and the AIDS Clinical Trials Group (ACTG, Neurology Subcommittee Chairman-Dr. Bruce Cohen through 2005, Dr. Ned Sacktor from 2006 through 2007).

Core Overview
The Clinical Outcomes Core plays a central role in the proposed center, and will interact with several of the Cores (see Figure 1). The Core is justified by the recognized need to develop new outcome measures for HIV-associated cognitive disorders in the era of highly active antiretroviral therapy (HAART) that are not only robust and well validated, but also sensitive to changes that are expected earlier in the development of HIV-associated cognitive impairment. Also, the statistical power of recent trials for HIV dementia has been limited by excessive variance in the scores of standard neuropsychological test batteries (1). There is currently no funding venue for the kind of outcome measure development proposed in this Core.  The individual responsibilities of key personnel are detailed in the Budget Justification. In brief, Dr. Ned Sacktor will direct this Core and oversee the collection of clinical data including neurological assessments. Dr. Ola Selnes will oversee the collection of neuropsychological data and assist Dr. Sacktor in subject characterization. Dr. Scott Zeger, Richard Skolasky, and Dr. Kelly Gebo will collaborate with them on the design, data collection and management, statistical analyses, and interpretation of the performance characteristics of the instruments. Dr. Richard Moore, a recognized expert in the development of touch-screen testing devices will supervise these aspects of the Core.