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Updated: Dec 29 2021

Interventional Studies

  • 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 reactionscompare 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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