In a randomized controlled trial of a new oral hypoglycaemic agent, 15 percent of patients assigned to the drug stopped taking it because of side effects. At final analysis, their outcomes were analysed within the drug arm. This analytical approach is called:

• A Per-protocol analysis
• B Sensitivity analysis
• C As-treated analysis
• D Intention-to-treat analysis ✓

Explanation

Intention-to-treat analysis keeps every randomized participant in the arm to which they were allocated, regardless of adherence, preserving the prognostic balance created by randomization. It reflects real-world effectiveness where patients discontinue treatment. Per-protocol analysis includes only those who completed treatment as planned and can exaggerate benefit if non-adherent patients differ systematically. As-treated analysis regroups patients by the treatment actually received, destroying randomization.

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

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