Clinical and Outcomes Based Research for Students

Course Faculty

Dr. Saleem Islam, MD, MPH

Dr. Matt Gurka, Ph.D

Dr. Robin Petroze, MD, MPH

Student Limit of 70

Purpose

Outcomes research is a genre of clinical investigation emphasizing measurement of patient (and in some cases population) health outcomes. There has been an explosion of interest in this form of scholarly pursuit in the past two decades as the field of Health Services research has moved into the mainstream. As a result, it has become critical that individuals involved in health care delivery should be facile with the methodology and principles, as well as being able to understand the clinical outcomes literature. The field has grown importance due to the increasing concern with the overall cost of healthcare in the United States and the world. It evolved from looking at geographic variations in costs and outcomes, to a wide array of factors that have an impact on patient and population well-being.

The very definition of ‘outcomes’ continues to broaden as issues important to patients, physicians, hospitals, policy makers, and even insurance agencies dictate what is measured. These can be as varied as – specific patient symptoms or survival, functional status, overall satisfaction, quality of life, costs, complications, utilization, opportunity costs, or other measures. It is important for medical students to understand both the importance of these different measures and how it ties into ‘outcomes’, as well as how to read articles with these data and apply the results to their patients.

In this track, the students will gain an understanding of the various building blocks involved in outcomes research, including basic statistical analyses, interpretation of the literature, clinical research design, resources critical for research (e.g. REDCap), and presentation of scientific data.

Goals and Objectives

  • Understand what ‘outcomes’ (and surrogate measures) mean and the relevance to practice as well as policy
  • Learn about the tools required to conduct clinical outcomes research and where to find them
  • Know the different funding agencies and grants that support Clinical Outcomes research (e.g. PCORI)
  • Be able to select and perform appropriate univariate statistical analyses
  • Understand the basic principles behind clinical research project design
  • Reinforce understanding of EBM and how to best interpret a clinical outcomes paper and describe applicability to their population(s)
  • Understand and be able to implement the process of presentation of scientific clinical outcomes data. This would involve being able to:
    • Create an effective abstract (meeting and manuscript)
    • Making an impactful poster
    • How to best present your data at the podium
    • Manuscript writing 101
  • Be able to implement the above in a clinical outcomes research project that can become a capstone project

Requirements

  • Attendance at all lectures and seminars
  • Completion of all assignments (e.g. assessment of a published study, assessment of statistical tests to perform on a dataset) and quizzes on time
  • Participation in group discussions during the course
  • Certificate of Distinction will be considered for students who complete above requirements and complete a clinical outcomes research project with presentation at a national meeting or published manuscript as a capstone

Timeline

  • Choose pathway (and project) in MS1 year and start the didactics
  • Complete the project in the MSRP portion of pathway
  • Continue didactics and seminars in MS2 year
  • Present project in MS2 and MS3 year
  • Complete Capstone and apply for Distinction (MS4)

Assessment

  • Participation in interactive lectures, seminars, and group sessions
  • Performance on quizzes
  • Evaluation of a published study for statistical analysis and design flaws (review of the published study)
  • Capstone project (if certificate of distinction desired)

Lecture Series

The students will be expected to attend the summer lecture series that will be available through the existing T-35 didactics. The following talks would be mandated for this track:

  1. Orientation and writing IRB/IACUC proposals
  2. Responsible conduct of clinical research
  3. Rigor and Reproducibility
  4. Research Career Roundtable discussion
  5. Writing an abstract and manuscript
  6. Presenting a Poster and an Oral talk

In addition to the above, there will be lectures and didactic reading materials on the following topics:

  1. Statistics for Clinical Outcomes Research – the Basics
  2. Clinical Research – Designing studies – What’s in a Name?
  3. Sources for Clinical Research Data
  4. Big Data – What is it and what do (or can) we do with it?
  5. Ethics of Clinical Research