The Research Methods and Biostatistics Core serves as a centralized resource for qualitative data support, statistical expertise and data management services for Center investigators. Core members have broad expertise and experience with data management, research design, qualitative data analysis and statistical applications. The Core also supervises quality assurance activities and the Data Safety and Monitoring Board. The Core leadership also actively pursues new research opportunities. These tasks are accomplished via two highly integrated modules: Formative Research and Biostatistics and Data Management.

The Formative Research Module serves the needs of Center investigators related to the design, implementation, analysis, and interpretation of qualitative and formative research activities. Core members provide expert consultation to investigators utilizing qualitative methods including study design, training, quality assurance monitoring, and data analysis. The module also provides training opportunities related to qualitative methodologies with particular emphasis on their relevance to health marketing.

The goal of the Biostatistics and Data Management Module is to provide a multi-disciplinary environment that supports success in health marketing and communication quantitative research. This module is responsible for developing and implementing systems of data entry, data management, computerization and data quality control.

The two modules work closely together to provide training for investigators in the latest data analysis and management techniques, to generate new collaborative health marketing and communication studies, and to supervise quality assurance and manage the Center’s Data Safety and Management Board. The two modules also work together to develop new methodologies for integrating qualitative and quantitative research. Through these Modules, the Core meets the needs of the Center and its investigators as well as making important methodological contributions to the study of Health Marketing and Communication.

OBJECTIVES

A. Specific Aims

It is the mission of the Core to coordinate method and statistics activities in the Center. The Core also assumes leadership over the Data Safety and Monitoring Board and supervises quality control management. Finally, core leadership will actively pursue new research opportunities. The core will accomplish these tasks through two highly integrated modules: Formative Research and Biostatistics and Data Management. The overall aims are to:

1. Organize quarterly seminars presenting center findings
2. Organize annual seminars on new qualitative and quantitative data analysis techniques.
3. Implement a system of data entry, management, and quality control across the Center.
4. Develop new methodologies for integrating qualitative and quantitative research methods.
5. Provide on-going support of qualitative data collection and analysis
6. Provide expertise in statistical consulting on project design including research proposal development, study endpoints, sample size determination, data collection form design, data management and plans for statistical reports and analyses.
7. Provide a liaison to the Lay Steering Committee
8. Direct and Supervise the Center’s Data Safety and Monitoring Board
9. Supervise quality control management.

The integration of these skills and resources into one Core has led to a synergistic interaction of disciplines to identify and develop specific technical methods and products that enhance the research productivity of the Center and support new and innovative research.

B. Background

Formative research is an essential aspect of the Center’s production of tools to reduce health disparities among socio-economic levels. The Formative Module (Module A) will gather information concerning the quality, effectiveness and acceptability of qualitative tools. It is the primary goal of the Center to focus on understanding how low income (mostly minority) consumers seek and process risk information and make health decisions. The faculty members to be affiliated with Module A have diverse research experiences and interests yet share a common interest in making health information readily accessible to racial/ethnic groups historically marginalized from public discourse about various health issues and concerns. Thus, it is imperative that diverse methodologies be employed in order to accurately represent the views, beliefs, and understandings of the target population.

The Biostatistics and Data Management Module will provide a multi-disciplinary environment to support success in health marketing and communication research. The module brings the methods and statistical expertise and resources needed for success. Core members support investigators in p lanning and study design, d ata analysis, database management, statistical methods, research, and development. In addition, the Core serves as a liaison to improve communication and coordination between investigators and statisticians who are potential collaborators. The Biostatistics and Data Management Module seeks to ensure that every project has the benefit of an interactive relationship between a biostatistician and principal investigator (P.I.) --beginning in the earliest stages of planning and design and continuing through to the publication of reports. Sound scientific design is a critical element of an ethical protocol that seeks to minimize the subjects’ risks while maximizing the likelihood of research success. All protocols submitted to the Center undergo review by the biostatistics core and must receive approval from this core. A second goal of the Biostatistics and Data Management Module is to provide on-going training to Center members on the latest data analysis and management techniques.