A randomized controlled trial evaluating a new antihypertensive medication requires all participants to complete a 2-week placebo run-in phase before randomization. Patients presenting with baseline BP 168/104 mmHg, HR 92/min, and no prior antihypertensive use are enrolled. Those who miss >20% of placebo doses or withdraw during run-in are excluded before assignment to treatment arms. Serum creatinine remains normal throughout. Which of the following best describes the primary purpose of this run-in design feature?
- A)Eliminate confounding by age
- B)Prevent lead time bias
- C)Measure incidence density
- D)Increase blinding of outcome assessors
- E)Identify likely nonadherent participants before randomizationGABARITO
Explicação
A run in period allows investigators to identify participants who are unlikely to adhere or tolerate study procedures before randomization. This can improve internal validity and reduce postrandomization dropout. However, it may also decrease generalizability ... Ver explicação completa e trilha adaptativa →