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The Outcomes and Biostatistics Core participates in a wide variety of activities, including consultation on design and analysis for small pilot projects, development of study design for major projects (e.g. R01 proposals), assistance and advice on database construction and management, collaboration on large projects where outcomes measurement and statistical analysis considerations are nontrivial, development of new statistical methodology, and mentorship for junior investigators and fellows. Core activities can be divided into three broad categories
Research, Training and Service Activities
Outcomes
We assist investigators in the selection and use of patient reported outcomes of all kinds. In some cases this involves selection among previously existing survey instruments, and in other cases that involves the development and testing of new instruments. Specific services include:
- Assistance with the development and testing of new outcomes measurement tools
- Facilitation of the choice of outcomes measures for new and proposed projects
- Assistance with statistical modeling of outcomes measures, including psychometric analysis
Study Design and Data Analysis
The core provides services in the form of consultation and collaboration related to study design and data analysis, which include:
• Database construction, including web-based entry
• Consultation on design, implementation, and interpretation of analyses for scientific publications
• Advice and consultation on use of statistical software packages and numerical computing routines
• Development and design and analysis sections for new grant proposals, ranging from basic power and sample size calculations to specialized analysis plans
• Development of new statistical methodologies that can be used to address difficult data analytic problems or that can be used to open up a new line of scientific investigation
Decision Analysis and Cost Effectiveness Analysis
The Core provides advice, consultation and collaboration in decision analysis and cost-effectiveness analysis including:
- Decision modeling
- Cost and cost-effectiveness analysis
- Micro simulation methods
Provide Mentorship to Junior Investigators
- Advise on study design and data analysis for junior faculty and fellows preparing developmental grants and applications for K award support
- Provide ongoing mentorship and statistical support for recipients of those grants
- Serve in mentorship roles for graduate students pursuing thesis research in HIV/AIDS
Additional Services
• Survey development – exploratory and qualitative research; cognitive testing; pilot testing
• Quality of HIV Care – measurement of physician-patient relationship quality; chart review methods; audiotape analysis
• Methods for measuring and analyzing medication adherence – self-report; electronic measurement methods; pharmacy database methods
• Analysis of HIV viral sequence data – Development of new self-contained software for evaluating quality of HIV sequences; development of software for converting nucleic acid sequences of the HIV RT genome into amino acids; design and analysis of studies examining long-term resistance profiles among different HIV subtypes prevalent in east Africa, southeast Asia and India.
• Design of experiments using high-throughput screening – specialized design of assay and experimental protocol for new experiments that screen hundreds or thousands of agents; development of new portable software routine for large-scale screening and significance testing in high throughput experiments.
• Analysis of intensive longitudinal data – development of new statistical tools for data collected from continuous monitoring devices such as MEMS caps in adherence studies.
Consultation and collaboration on projects related to Neuro-AIDS – Design and analysis for studies relating cognitive function to image-based measures of brain morphology; formation of research interest group from Computer Science, neuroscience, and psychiatry relating to diffusion tensor imaging technology (DTI) to assess white matter injury in HIV.
CFAR Core Services Evaluation
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