The Biostatistics Core provides protocol development, along with analytic and technical writing services for specific research projects.

The Biostatistics Core is headed by Dr. Paul Kolm at the Christiana Care Center for Outcomes Research, a multidisciplinary research group with expertise in clinical medicine, epidemiology, biostatistics, informatics and health economics.

It is run as a fee-for-service core.

Here are some of the services offered by the core:

Research design. Biostatistics Core personnel can assist investigators in the development of a research protocol with respect to specific aims, hypotheses and study design. Core personnel have expertise and experience in all types of epidemiologic designs, observational and retrospective, as well as randomized clinical trials.

Development of analytic data sets. This includes consultation / assistance in development of data collection strategies, variable descriptions and codebooks, database structure and transfer of data files for analysis by biostatisticians.

Statistical analysis. Core biostatisticians can provide a comprehensive approach to the statistical analysis of research projects.  This includes writing a statistical analysis plan for the proposal, power and sample size calculations, running the statistical analyses, and writing reports of the results including appropriate tables and graphs. Core biostatisticians will also provide consulting services related to sample size calculations, advice on appropriate statistical methods and optimal strategies for presentation of results.

Core personnel have expertise and experience in a wide variety of statistical methods including standard descriptive and inferential statistics, multiple imputation of missing data, general and generalized linear models, cluster analysis, linear mixed models, structural equation modeling, nonlinear regression, latent growth curve modeling, survival analysis for single and multiple events, cost-effectiveness analysis, multilevel modeling, meta-analysis, multivariate analysis, time series analysis, classification and tree regression, power and sample size calculation, propensity score methods, inverse probability-weighting, instrumental variable analysis, Monte Carlo Markov Chain methods, bootstrap methods and Bayesian sensitivity analysis.

Manuscript preparation. Biostatistics Core personnel can assist in writing methods and results sections of manuscripts to be submitted for publication, or respond to reviewer comments related to design and statistics.  In addition, Core personnel can assist with analyses and preparation of abstracts to be submitted for presentation at national / international scientific meetings.

Core method:

Initially, contact with the Biostatistical Core can be made by contacting the Core personnel named below.  Required information from investigators includes a copy of the proposal (if only a draft) with objectives / specific aims / hypotheses and methods, clear definition of the research population, and a data dictionary listing outcome and other variables obtained in the study.  Eventually a template for requests will be made available on the BADER website.  Ideally datasets could be transferred through the website.  Another solution is to set up FTP transfers.

Paul Kolm, Ph.D., is the director of biostatistics for Christiana Care Health System and the Christiana Care Center for Outcomes Research.

Dr. Kolm leads a team of one senior-level and two master’s- level biostatisticians. They provide statistical analysis for a wide range of studies, including randomized trials of the effectiveness and efficiency of medical technologies and treatments, comparative effectiveness from observational studies and registry data, and economic analyses. He is also co-investigator and lead biostatistician for several research projects funded by the National Institutes of Health and health care industry.

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