Research Methodology
A pharmaceutical company sponsors a multicentre trial evaluating a new bisphosphonate for osteoporotic fracture prevention. Postmenopausal women with T-scores less than -2.5 are randomly assigned to receive either the new drug or placebo for 3 years. The primary outcome is incident vertebral fractures confirmed by radiography. Neither participants nor outcome assessors know group allocation. Regarding randomized controlled trial (RCT) methodology:
Mark each as TRUE or FALSE
Randomization reduces selection bias by ensuring that known and unknown confounders are equally dist...
Double-blinding (participant and assessor blinding) minimizes performance and detection bias; when b...
RCTs provide Level III evidence according to NHMRC and Oxford criteria; cohort studies provide highe...
Intention-to-treat analysis includes all participants as randomized regardless of compliance or cros...
Sample size calculation requires specification of expected effect size, acceptable Type I error (alp...
Answer the questions to see explanations
Click T (True) or F (False) for each option