Biostatistics Data Collection & Management Core
The purpose of this core is to provide expertise to cancer researchers in the following areas:
- Biostatistical analysis
- Epidemiological and clinical research methodology
- Henry Ford Health System databases
- Computer programming and data management
- Data collection
- Molecular epidemiology research laboratory
The Biostatistical Analysis Core includes access to a team of masters and doctoral-trained biostatisticians experienced in the areas of applied and theoretical statistics. Together, the staff participates in many aspects of cancer research:
- Study Design: In this phase of research, the staff collaborates on designing the experiment, addressing sample size requirements and developing data collection methods.
- Data Analysis: This is the primary activity, with emphasis on proper methodology and communication of the results to the investigator in an understandable form. Selected staff members are proficient in the analysis of "omics" data.
- Clinical Trials: The staff has expertise in designing clinical trials, monitoring their progress, and managing and analyzing data collected from multiple sites. As members of a study group, staff serve on steering committees, participate on subcommittees, conduct data safety monitoring, statistical analysis, and collaborate on study publications.
- Grant Preparation: The staff also has extensive experience with proposal development and the preparation of National Institutes of Health (NIH) and other grants. They also may assist with study design and protocol development, selection and piloting of questions and other data acquisition tools.
Edward Peterson, Ph.D.
The masters- and doctoral-trained staff members have expertise in epidemiologic methods, including genetics, and the epidemiology of various cancers. Their areas of expertise include:
- Study Design: The Research Epidemiology Division collaborates with investigators in study design and development of study protocols, particularly for observational studies. They are trained to design studies that take into account the potential biases that can occur in a non-randomized study. They also assist with the design of the forms and questionnaires, which will be used to record information in the study.
- HFHS Database Analyses: Staff members are proficient in the manipulation of managed care databases and the databases included in Henry Ford Health System's Corporate Data Store (CDS), as well as the Henry Ford Cancer Institute tumor registry. They are experienced in identifying patient populations of interest, profiling practice patterns and providing descriptive information related to specified study interests.
- Pharmaco-epidemiology: A team of epidemiologists, health services researchers, programmers, data managers, and medical record abstractors with a focus on the conduct of pharmaco-epidemiological studies related to the use of medications, including the evaluation of short and long term effects of medications, the usage of medications, including appropriateness and safety, and medication adherence.
Lois Lamerato, Ph.D.
The programming and data management staff have expertise in the following areas:
- The design, testing, and maintenance of research databases
- The design, testing, and maintenance of data collection instruments
- Development of consistency checks and quality control procedures
- Generation of schedules and ad hoc reports
The Data Collection Core's activities also include:
- Medical Record Abstraction: Credentialed medical abstracting staff members, including a number who are certified tumor registrars, provide support for research studies. These abstractors identify, collect and interpret specified data by reviewing documents in the medical record, including physician notes, health histories, operative notes, pathology reports, lab reports, discharge summaries, consults and inpatient stays. Abstractors also provide expertise in abstract development, including form design and layout, piloting of new abstracts, and development of abstractor guidelines and definitions.
- Interviews: Staff members conduct face to face and telephone interviews for research data collection. Core research interviewers pilot and assist in the design and flow of the interview. Duties include scheduling, interviewing, tracking, coding, and editing of the data.
- Data Entry: Staff members are also primarily responsible for the input of data into computerized files. To assure accuracy, they provide double-entry verification as required.
The molecular epidemiology research laboratory supports investigator-initiated epidemiologic studies with a basic science or biomarker component. The laboratory is located in the Henry Ford Health System research facilities and offers the following areas of expertise and capabilities:
- Sample recording, tracking, processing and storage, integrated into BRE databases
- Nucleic Acid (DNA, RNA) isolation
- Genomic analyses: SNP, STR, RFLP, sequencing, DNA methylation
- Expression analyses: Reverse transcription/PCR
- Flow cytometry for cellular markers
- Access to additional analytical equipment at the Wayne State University Environmental Health Resources Center, where the laboratory director is a member
Kim Woodcroft, Ph.D.