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Comparative Effectiveness Research Study Design

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Notes

Recorded at the Comparative Effectiveness Research with Population-Based Data Conference, Baker Institute at Rice University, 2012. Presented by Matt Maciejewski, PhD, Professor in the Department of Population Health Sciences. 

 

Learning Module Notes Modules

  • Rigorous Quasi-Experimental Comparative Effectiveness Research Study Design

    1. Introduction (0:00-8:20)
    2. Mary Beth Landrum’s presentation: Use of Geographic Variation to Estimate Effectiveness With Nonrandomized Data (8:20-1:11:36)
    3. Principles around study design (1:13:30-1:16:54)
      • Objectives
      • Limitations to internal validity
      • Strengths of external validity in quasi-experiments 
    4. Experimental studies/RTCs enable causality statements (1:16:54-1:18:31)
      • RCT is considered the gold standard
      • Not the case in quasi-experiments – conditions for causality in the absence of randomization
    5. Value & Motivation of Quasi-Experimental Studies (1:18:31-1:26:11)
      • What makes an ideal Quasi-Experimental Study
      • Internal validity: Refers to the ability to make casual inferences
      • The controversy between experimental and quasi-experimental research
      • Overall point of lecture: What are the design choices that must be considered to ensure a well-designed quasi-experiment in CER?
    6. 4 Design Choices for Rigorous Quasi-Experiments: (1:26:11-1:27:10)
      • In absence of randomization: incident or prevalent users, control group, pre-period measurement, post-period measurement 
    7. Incident & Prevalent User Designs: (1:27:10-1:30:32)
      • 3 Cohort Choices: Incident (new) users, prevalent users, both
      • Tradeoffs of incident user design
      • Defining pre-period for incident cohort designs 
    8. Example: Incident Cohort Study (1:30:32-1:32:47)
    9. Considerations before using Prevalent User Cohort: (1:32:47-1:40:55)
      • Tradeoffs in prevalent user design
      • Defining pre-period for prevalent cohort designs
      • Choice of inclusion criteria can impact adherence estimates
      • Incident vs Prevalent Examples
    10. The Role of Counterfactuals for Internal Validity (1:40:55-1:53:12)
      • Importance of a control group
      • What is a counterfactual? Ways of estimating.
      • Counterfactuals in quasi-experiments
      • Assuming you have non-equivalent controls
      • Selection of control group
      • Take-aways of user cohorts
    11. Threats to Internal Validity (1:53:12-2:00:47)
      • Selection, ambiguous temporal precedence
      • Example
      • History & maturation; threats to internal validity 
    12. Measurement Issues for Internal Validity (2:00:47-2:04:25)
      • Pretests, posttests, non-equivalent dependent variables
      • External validity
      • CER/Translation research
    13. Bottom line for quasi-experimental study designs & Conclusions (2:04:25-2:05:11)
    14. Q&A (2:05:11-2:17:33)
  Learning Modules