In an intention-to-treat (ITT) analysis, participants are analyzed according to:
- A The group they were randomized to, regardless of compliance or withdrawal ✓
- B Their actual treatment received regardless of randomization
- C Completers only who followed the protocol
- D The group determined by an independent data safety monitoring board
Correct answer: A. The group they were randomized to, regardless of compliance or withdrawal
Explanation
Intention-to-treat (ITT) analysis includes all randomized participants in the groups to which they were originally allocated, regardless of treatment compliance, withdrawals, or protocol deviations. ITT preserves the benefits of randomization (balance of known and unknown confounders) and provides a conservative estimate of treatment efficacy reflecting real-world effectiveness. Per-protocol analysis includes only compliant participants and is susceptible to selection bias.
Reference: Park's Textbook of Preventive and Social Medicine, 27th ed.
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Written and medically reviewed by the StethoPrep medical team.