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Clinical Investigation
4th term
3 credits
Academic Year:
2012 - 2013
East Baltimore
Class Times:
  • Tuesday,  5:30 - 8:30pm

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Auditors Allowed:
Yes, with instructor consent
Grading Restriction:
Letter Grade or Pass/Fail
Cristina DeNardo
Course Instructor:

Introductory biostatistics course sequence (e.g., 140.611-612 or 140.621-623), SOCI student, or consent of instructor.


Provides an overview of outcomes and effectiveness research. Emphasizes conceptual, design, and analytical aspects of research, rather than particular findings or policy implications. Covers both experimental (randomized) and observational designs, with greater emphasis on the latter. Examines alternative approaches to addressing confounding in controlled observational studies. Explores methods for evaluating the effectiveness of patient-level interventions (e.g., treatments and procedures), as well as methods for evaluating the effectiveness of providers and provider-level interventions (including by application of multilevel models). Considers a wide range of outcomes, including time to event outcomes (survival analysis), cost of care (cost-effectiveness analysis), and patient-reported outcomes.

Learning Objectives:

Upon successfully completing this course, students will be able to:

  1. Develop skills needed to critically evaluate outcomes and effectiveness research
  2. Craft a preliminary design for an outcomes or effectiveness study
  3. Describe the strengths and weaknesses of various experimental and observational study designs
  4. Recognize how various statistical approaches reflect and illuminate study aims
  5. Describe a wide variety of approaches to outcomes and effectiveness investigation
Methods of Assessment:

Based on a final project consisting of a preliminary research proposal.

Instructor Consent:

No consent required

Special Comments:

Fifth in a five-course series in the science of clinical investigation.