Intention-to-treat (ITT) analysis in a randomised controlled trial is preferred over per-protocol analysis because ITT:

• A Only analyses patients who completed the full treatment course
• B Preserves the prognostic balance of randomisation and reflects real-world effectiveness ✓
• C Excludes non-compliant patients to show the maximum possible efficacy
• D Eliminates selection bias by removing protocol violators

Explanation

ITT analysis includes all randomised patients in the group to which they were allocated, regardless of whether they completed treatment or crossed over. This preserves the prognostic equivalence created by randomisation and provides an estimate of real-world effectiveness (including non-compliance). Per-protocol analysis, by excluding dropouts and non-compliers, introduces selection bias and may overestimate efficacy. ITT analysis is the conservative, intention-to-treat gold standard for RCTs.

Reference: Park's Textbook of Preventive and Social Medicine, 27th ed.

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Written and medically reviewed by the StethoPrep medical team.