Design, Methods, Biostatistics, and Economic Analysis Core

The Design, Methods, Biostatistics, and Economic Analysis Core will provide advice, training, and assistance to CEBP project investigators and other CUMC self-management investigators. Service requests and fulfillment of service requests will be tracked through the CTSA WorkWeb as described in the Evaluation Plan. The timeline for development and evaluation of services is also included in the Evaluation Plan. Core experts will advise self-management investigators on various aspects of the research process including: selection of a research design, matching aims and research design, creating an appropriate control group for a self-management intervention, outreach strategies to maximize participation from underserved populations, and selecting analytic strategy. In addition, they will advise CEBP project investigators (Aboelela, Capili, Currie, Smaldone) on how to maximize what is learned from their projects as preliminary studies for future R01 submissions. The primary approaches for training will be: 1) the Interdisciplinary Methods for Self-Management Research Seminar;2) referrals to existing educational offerings at Columbia;and 3) economic evaluation workshops. The Interdisciplinary Methods for Self-management Research Seminar comprises 20 one hour sessions per year to be divided among Cores. Five sessions each year will be devoted to topics related to the Design, Methods, Biostatistics, and Economic Analysis Core. Dr. Jia will provide a series of lectures on selected statistical topics such as power analysis, sampling techniques, and temporal analyses. Dr. Anastasi will address the topics of outreach for research participants from underserved populations and considerations in designing an appropriate control group for self-management intervention trials. In addition, Dr. Anastasi and Dr. Jia will refer project investigators and other self-management investigators to relevant training on the Columbia campus including the course that Dr. Jia teaches in the Department of Biostatistics. As noted in the RFA for this submission, research is needed on the economic effects of self-management for the individual, for those around them, and for society at large. Consequently, our submission includes an aim explicitly designed to meet this need. A key component for achieving this aim is familiarizing a cadre of selfmanagement investigators with economic evaluations. Dr. Stone in consultation with External Advisory Board member Kevin Frick, PhD will develop a series of workshops to provide CEBP project investigators and other CUMC self-management investigators on a space-available basis with knowledge and skills in economic evaluation. Because high quality rigorous economic evaluations can be complex and it takes time to gain mastery, the goal will not be to develop the investigators to become independent economic researchers, but rather to familiarize the new self-management investigators with the economic terminology, types of economic analyses and the resources available to them so they may effectively: 1) develop appropriate specific aims regarding resource utilization, quality of life and/or cost-effectiveness and 2) engage other appropriate interdisciplinary experts as collaborators. Resources and experts internal to the University as well as national expertise will be used. All CEBP project investigators will participate in the economic analysis workshops. In Year 1, four 2-hour workshops will be held on the following topics: 1) overview of economic evaluations (2 sessions);2) resources for economic evaluations;and 3) critiquing economic evaluations. In Year 2, the project investigators will develop an economic aim of relevance to their particular project, select the appropriate economic method to achieve the aim and under Dr. Stone's direction, and construct an analytic plan in consultation with an interdisciplinary expert. We will repeat this series in Years 3 and 4. Investigators wishing additional training in economic analysis will be referred to workshops and courses on the Columbia campus such as P8541: Advanced Economics: Technology Assessment and Economic Evaluation. They may register for such offerings tuition-free as a faculty benefit. In addition to advising and training activities, Core experts and other CEBP personnel will assist CEBP project investigators and other self-management investigators with tasks such as design of analytic plans, power analysis, selection of appropriate statistical software, data management strategies, and code book development and data entry (Graduate Research Assistant funded in Administrative Core).