Updated: 10/13/2020

Interventional Studies

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Overview
  • Interventional studies are prospective studies designed to evaluate the direct impact of therapies or preventative measures by assigning subjects to intervention groups
  • 2 types of interventional studies
    • clinical trials
      • individuals assigned to competing intervention groups
    • community interventions
      • assigment at the group level (e.g., one community receives fluoridinated water and one does not)
  • Highest quality if
    • randomized 
    • controlled
    • double-blinded
Clinical Drug Trials
  • 4 phases for clinical trials evaluating new drugs
    • phase I 
      • small number of healthy subjects (<100)
      • purpose
        • safety and dosage
    • phase II 
      • small number of diseased patients (100-300)
      • purpose
        • efficacy and side effects
    • phase III
      • large number of diseased patients (>1,000)
      • purpose
        • effectiveness and monitoring of adverse reactions
      • compare to standard of care
    • phase IV 
      • post-marketing surveillance
      • purpose
        • detects rare or long-term adverse effects
Factorial Design
  • Randomizes patients into different interventions with 2 or more variables being studied in each intervention 
    • allows researchers to study the effects of multiple independent variables independently and mutually on a dependent variable
      • e.g., group 1 studies effect of treatments A+B on variable X, group 2 studies effects of A alone, group 3 studies effect of B alone, and group 4 is the control group receiving no treatment
Crossover Design
  • Participants alternate receiving intervention and placebo
  • Participants act as own controls 
    • improves power and precision of study
    • need washout period between interventions
    • all patients receive intervention
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