Box 1Using the hypothetical randomized controlled trial (RCT) to guide test evaluation

  • State the major claims for the new test to improve patient outcomes.
  • Describe whether it will be used as a replacement, add-on, or triage test to achieve these claims.
  • Design a hypothetical RCT of the test-and-treatment strategy to investigate these claims. Construct a flow diagram to show its key elements, including target population, prior tests, and the pathway linking testing to patient outcomes.
  • Label on the flow diagram all differences between the new and existing test strategy that can be linked to patient outcomes.
  • Specify the type of comparative evidence needed to measure these differences.
  • Outline what assumptions need to be made if comparative accuracy and other observational studies of elements of the flow diagram will be used instead an RCT
  • Judge whether these assumptions are reasonable.

From: Using the Principles of Randomized Controlled Trial Design To Guide Test Evaluation

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