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Epi-Bio Core

The Epidemiology-Biostatistics Research Support Core fosters excellence in research by providing epidemiologic and biostatistical expertise and education to the academic health center.

• The services are available to all EVMS faculty, staff, residents, and students.

• Biomedical research requires rigorous methodological rationale combined with strong quantitative analyses.

• In clinical studies, where the number of patients studied is often small, even minor errors in study design can lead to serious misinterpretation of the data.

• Epidemiological and biostatistical approaches are integral parts of the development, implementation, and analysis of clinical research programs.

• Combined with ongoing instructional needs in statistics and research methods, EVMS established Epidemiology-Biostatistics Research Support within the School of Health Professions in 2003.

Faculty

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Research and Teaching Services

• Study Design: protocol and methods development, drafting of research plans, timeline creation, sample size calculations.
• Data Analysis and Interpretation: writing analysis plans, conducting statistical analysis, creating data presentations, writing results sections.
• Database Design and Management: creation of relational and flat file databases for data collection, using techniques to maximize data quality and built-in data quality checks.
• Survey Design: survey creation, survey review and consultation, validation/pilot testing.
• Publications and Presentations: review and serve as co-authors on papers for professional publications, and prepare poster presentations using PowerPoint.
• Grant Preparation: provide technical assistance and collaborate with the EVMS Office of Research to assist faculty with grant writing.
• Protocol Development: assist investigators in preparing protocols for observational studies or large multi-center trials.

Study Design

EpiBioCore Support faculty have extensive experience in diverse study designs including clinical trials, cohort studies, case-control studies and cross-sectional studies. Be prepared to discuss focused, reliable, measurable outcomes, and affiliated variables, as well as details of possible interventions.

Data and Interpretation

Data analysis usually follows data management, which helps to ensure data integrity. In addition, IRB approval must be obtained before any data will be analyzed. Any prior analysis protocols should be given to the analyst at the first meeting and any corporate affiliations declared.

Authorship is expected for any results cited.

The request for data analysis must specify which variables in the dataset should be used to answer the questions. Be prepared to explain how data were collected, as this may influence the interpretation of results. No general data mining will be done without the express consent of the EpiBioCore Support Director.

Upon completion of the data analysis, the requestor will receive a completed statistical methods section and formatted results with tables/graphs as appropriate, unless specifically requested otherwise. A follow-up meeting will be scheduled to discuss the interpretation of results.

Design and Management

Databases are constructed using Microsoft Access. The database is constructed so that a friendly data interface is used for actual data collection, and extensive data experience is not necessary to achieve the highest data quality and integrity. Clients using older versions of Microsoft Access need to highlight this on their Request for Service Form, and there may be some delay associated with conversion of the file.

Data management encompasses data cleaning, quality checks, formatting, and transference into alternative data programs, including SAS, SPSS, Excel, Access, and others. Prior to any data management, the current database must be in an electronic format (no paper databases will be accepted) and accompanied by a complete codebook. A codebook describes each variable name, description, variable type, data ranges and codes.

Design

Our faculty can assist in designing survey instruments that minimize respondent bias and burden, in multiple formats including mail, telephone and personal interviews, and identify sampling frames that provide the best possible coverage of any target population. Assistance with the overall survey process can also be obtained from members of the core offering advice on the number of call-back attempts for telephone surveys, the type of mailed questionnaires that are most useful, or the assignment of respondents to personal interviewers, for example. Consultation can be given regarding the use of focus groups for creating and/or validating survey instruments.

Presentations

Abstract and manuscript preparation assistance is available, but usually follows study design assistance and/or data analysis. The requestor is responsible for a thorough literature review and disclosure of all results. Data should be available to confirm results cited. Please include meeting or journal formatting requirements.

Authorship is expected for significant contributions.

Oral and poster presentation assistance is available. Presentations are generated using Microsoft PowerPoint, but can be converted to slides if needed. Requests of this nature should be accompanied by either an abstract with further supporting results or a completed manuscript. Please include meeting requirements for length and formatting specifications.

Preparation

We have experience in assisting with successful grant submissions with several agencies, including NIH, AAP and others. Grant submissions usually involve study design and statistical consulting and, whenever possible, the EpiBioCore Support faculty should be involved in subsequent analysis plans and be included in the grant budget. This is considered a highly interactive process that requires a large time commitment from the requestor and top quality input from core faculty, so please be prepared with all grant content and formatting requirements.

Development

EpiBioCore Support faculty have written several detailed protocols for small observational studies as well as large multi-center trials. This request generally follows grant acceptance, and samples can be produced. Staff are also available to serve on data monitoring boards.

Authorship and Acknowledgments

If faculty of the Epidemiology-Biostatistics Research Support contribute to the design or analysis of a study, or help develop presentations or publications for the study, they are to be included as authors.

The faculty contributing these services will review the final version of the presentation or publication prior to submission. Guidelines for Authorship and Acknowledgments are set forth in the New England Journal of Medicine, and we request that persons requesting services from EpiBioCore Support faculty or staff review these guidelines.

Teaching Services

There is considerable expertise in the biostatistical and epidemiological sciences among the EpiBioCore Support faculty. In addition to ongoing teaching responsibilities for medical and health professions students, faculty may be available on a limited basis to provide individual lectures and seminars. Persons seeking such services should complete the Request for Service Form and email to This e-mail address is being protected from spambots. You need JavaScript enabled to view it . Faculty may also be available to develop and instruct full courses in different aspects of biostatistics or epidemiology. To request these services, a brief proposal should be attached to the form referenced above describing the need for the course and the general content, the department or organization sponsoring the course, the estimated number of students, the start and end dates of the course, and the funding source for the course. As a general rule, requests for new courses should be submitted at least three months in advance.

Resources

EpiBioCore Support offices are located on the 4th floor of the Educational and Research Building of the Eastern Virginia Medical School campus. As shown below, the EpiBioCore Support uses a variety of resources for statistical computation and simulation, as well as creation and management of datasets suitable for use in statistical analysis:

• • SAS
  • SPSS
  • JMP
  • STATA
  • R

FAQ - Frequently Asked Questions

Who can use the Epidemiology-Biostatistics Research Support?

The services are primarily intended for EVMS faculty, staff, residents and students.

At what stage of research is it best to seek advice about research design, methodology and statistical analysis?

The earlier in the process, the better. Nothing is more frustrating than learning after the fact that your data are inadequate for valid statistical inference, or that your time and resources were wasted from gathering more data than was necessary. We recommend that you see us during the pre-proposal phase of your research.

How do I schedule an appointment?

Please e-mail This e-mail address is being protected from spambots. You need JavaScript enabled to view it and attach a completed Request for Service Form, identifying the type of service needed. This form is used to prioritize requests and identify the appropriate faculty or staff to provide consultant services, who will then contact the requestor to schedule an initial appointment.

How will requests for services be prioritized?

Each request will be assigned a priority score based on the type of service, potential for or availability of funding, project deadline, and other variables such as IRB approval. Collaborative and funded projects will receive higher priority, if timelines are short. The requestor will be told an expected time of completion at the first consultation.

What should I bring to the first consultation?

Please bring the latest version of your proposal, including the hypotheses and/or the specific aims. Also, bring copies of articles or earlier work on similar topics in your discipline. It will help if you are prepared to discuss focused, reliable, and measurable outcomes and affiliated variables, as well as details of possible interventions. For advice on data analyses or report writing after the fact, please bring a copy of the IRB Approval notice (if required), the data gathering/analysis protocol, the current database in an electronic format (accompanied by a complete codebook), and the results of analyses already performed. Please prepare well-defined outcomes and research questions to be answered. If the assigned consultant cannot answer all of your questions in one session, they will (a) schedule a follow-up appointment, and (b) find the information you need, either by delving into the relevant epidemiological or biostatistical literature, or by consulting with a colleague who has the expertise required.

How are Epi-Bio Research Support Services paid for?

Generally there are three ways to pay for services. First, by direct support of named individuals on grants, provided that prior approval has been obtained from that individual and the EpiBioCore Research Support Director. Second, through institutional Core support, provided that such expenditures have been approved by the appropriate officials.

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