A case study of ascertainment bias for the primary outcome in the Strategies to Reduce Injuries and Develop Confidence in Elders (STRIDE) trial.

Denise A EssermanThomas M GillMichael E MillerErich J GreeneJames D DziuraThomas G TravisonCan MengPeter N Peduzzi

Published in: Clinical trials (London, England) (2021)

There was evidence of ascertainment bias in the Strategies to Reduce Injuries and Develop Confidence in Elders trial. The decision to adapt the primary outcome definition reduced the likelihood of this bias while preserving the intervention effect and study power.

Keyphrases

study protocol
phase iii
phase ii
randomized controlled trial
clinical trial
community dwelling
open label
decision making