Community Medicine (PSM) · Epidemiology (Study Designs, Bias, Systematic Review, Measures of Association)

In a randomized controlled trial comparing two antihypertensive drugs, analysis is done only on patients who completed the full 12-month follow-up, excluding dropouts. This analytical approach is termed:

  • A Per-protocol analysis
  • B Intention-to-treat analysis
  • C Modified intention-to-treat analysis
  • D Sensitivity analysis
Correct answer: A. Per-protocol analysis

Explanation

Per-protocol analysis restricts the analysis to participants who adhered to the assigned protocol and completed follow-up, which can introduce selection bias. Intention-to-treat analysis includes all randomized participants regardless of adherence, preserving prognostic balance from randomization. Modified ITT excludes participants who never received any treatment. Sensitivity analysis tests robustness under different assumptions.

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

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