Medical Student Research Fellowship for Summer 2007

Mentor: T. Michael Kashner, PhD JD MPH
Department: Clinical Sciences & Psychiatry
Room number: FL8.813 (Exchange Park)
Mail Code: 9086
Phone number: (214) 648-4608
E-mail: michael.kashner@va.gov; michael.kashner@utsouthwestern.edu
Project title: Assessing Cost and Outcomes for the Sequenced Treatment Alternative for Resistent Depression (STAR*D).

Human subjects IRB approved project number: 0900-454

Animal subjects IRB approved project number (where applicable):

Project Type (patient-based research, animal-based research, or basic research; this characterization is only to permit a general classification for grouping similar types of projects)

Brief Description of Project:

This study will apply advanced statistical modeling to analyze cost, use of care, and health outcomes data to compute cost outcome ratios for selected treatments using data from the Sequenced Treatment Alternative to Relieve Depression (STAR*D) trial, a $28m National Institute of Mental Health funded, randomized trial of 4,020 outpatients with major depression receiving medication treatments at 41 clinical sites. The purpose of this study is to assess cost-effectiveness of sequenced medication algorithm in actual clinical care settings.

The goal of this summer project is the submission of the published manuscript for review in a scientific publication. The fellow will be listed as an author to the paper. The fellow will have an opportunity to explore advanced analytic methods to estimate and test cost-effectiveness ratios in assessing clinical outcomes and costs of treatments for patients with major depression. The fellow will also be involved in the preparation of a scientific manuscript that will be submitted to a peer-reviewed scientific journal. The experience will also help the fellow understand how data from large clinical trials are analyzed to measure cost-outcome ratios, and interpreting this information in assessing clinical care in actual practice settings. Included in this work will be an improved understanding of the conceptual definition of costs, how it can be measured, and how treatments and their costs are associated with clinical outcomes to measure cost-outcome ratios.

STAR*D data for this study have been collected under an IRB approved protocol (listed above). The data consist of 1-2 years of outcomes and use of care information on 4,100 patients with depression at 41 clinical sites across the US. Data are prepared in a research ready file format for direct analyses using advanced statistical methods. Analyses will be done by study investigators, with parts completed by the fellow under the direct supervision of the mentor (Kashner) and technical assistants, per the terms of the approved IRB protocol. To accomplish this, the medical fellow will review clinical, evaluative, and health service literature to enhance his understanding of standard analytic methods, theory generation, and hypothesis testing for such longitudinal outcomes and cost data. The fellow will be guided to develop the analytic plan to test selected hypotheses and ultimately to compute cost-outcome ratios for selected clinical strategies evaluated in STAR*D. With this knowledge, the fellow will prepare analytic files for analyses, conduct the analyses, and interpret findings, help in the preparation of the scientific manuscript for publication, and prepare a submission for presentation at a national meeting.

Previous Research Activities or Publications with Medical Students:

None.