Table 1

The datasets for a hypothetical diagnostic study, a hypothetical RCT and the example RCT (left to right respectively)

Hypothetical diagnostic test dataHypothetical RCT dataData from the Teprotumumab trial
Gold standardOutcome statusProptosis response
TestTnTTotalTreatment+ve−veTotalTeprotumumab+ve−veTotal
+ve8060140T8020100T34741
−ve204060nT6040100nT43842
Total100100200Total14060200Total384583
  • Note that the hypothetical diagnostic study and the hypothetical RCT data are the same but just interpreted differently in the two designs

  • nT, not treated; RCT, randomised controlled trial; T, treated; +ve, positive test status in diagnostic study or reached defined outcome in RCT; -ve, negative test status in diagnostic study or did not reach defined outcome in RCT.