Section outline

    • This module addresses common errors in the interpretation of the cause-effect relationship in clinical studies. The concepts of random chance, bias, and confounding as they relate to the design and interpretation of clinical studies are introduced. Strategies are presented to reduce errors and strengthen study conclusions regarding the cause-effect relationship. 

    • objective Objectives

    • After completing this module, students should be able to:

      • Describe cause-effect relationships and enumerate the four rival explanations.
      • Identify ways to minimize the likelihood of a spurious association due to chance.
      • Discuss bias and identify strategies for avoiding bias in clinical research.
      • Identify ways to make confounding less likely in observational research.
      • Offer several suggestions or strategies for incorporating opportunistic observational designs.
      • Explain how causal inference can be enhanced by positive evidence.

    • Readings Reading

    • In Designing Clinical Research, 4th Edition, by Hulley et al.

      • Chapter 9: Enhancing Causal Inference in Observational Studies
      • Chapter 11, Alternative Clinical Trial Designs and Implementation Issues

    • Lecture Lecture

    • Causal Inference or Truth in the Universe Slides File

    • Small Group Sections

    • Small group sections for this module take place on Monday during the fourth week (see section roster for your assigned time and Zoom link):

    • Assignments Assignments

    • Rather than emailing this assignment to your section leader, please incorporate it into your final research protocol before uploading your protocol onto the course website. See the next section on Final Protocol Submission and Review for the upload link and instructions.


    • ENHANCING CAUSAL INFERENCE ASSIGNMENT - incorporate this into the final protocol you upload at the end of the week Forum
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    • Exercises Optional Exercises

    • Optional Exercises -- Enhancing Causal Inference Quiz
      Not available unless: You belong to Registered Student Only