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Slide Presentation of the 2007 Annual Meeting of AHRQ

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Advantages of Observational Studies

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  • RCT's rarely powered for ADE's.
  • RCT's have poor external validity.
    • May not generalize to the patient population for whom the intervention may be applied.
      • Women, children, minorities, very elderly are under-represented.
      • Multiple drug choices and alternatives.
      • Co-morbid conditions.
      • RCT setting, health care providers is "artificial".
  • Longer term follow-up is usually achievable.
  • Facilitates risk management and risk minimization.
  • Enables better translation.
    • Interventions that are efficacious under a highly specific set of circumstances often fail to replicate across a wide variety of settings, conditions, patients.

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