Randomized controlled trials (RCTs) are typically designed to evaluate whether one intervention is superior to another. Noninferiority RCTs aim to demonstrate that a new therapy, which may be less burdensome or costly, is not appreciably worse than a comparator. In this chapter we discuss features of noninferiority design and provide a framework for critical appraisal of such trials.

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Assessing Noninferiority Randomized Controlled Surgical Trials

  • Alla Bengizi,
  • Mansi Patel,
  • Sandra Ofori,
  • Yaadwinder Shergill,
  • Jason W. Busse

摘要

Randomized controlled trials (RCTs) are typically designed to evaluate whether one intervention is superior to another. Noninferiority RCTs aim to demonstrate that a new therapy, which may be less burdensome or costly, is not appreciably worse than a comparator. In this chapter we discuss features of noninferiority design and provide a framework for critical appraisal of such trials.