In a randomized controlled trial, the intervention and control groups differ at baseline in age despite randomization. The most appropriate method to handle this imbalance is:

• A Repeat the randomization
• B Exclude elderly participants and re-randomize
• C Use stratified randomization in all future trials
• D Adjust for age using ANCOVA or multivariable regression in the analysis ✓

Explanation

Despite randomization, chance imbalance in baseline variables can occur, particularly in smaller trials. The appropriate response is to adjust for the prognostic covariate (age) using ANCOVA or multivariable regression at the analysis stage, not to re-randomize. Exclusion would introduce selection bias. The CONSORT guidance recommends pre-specified adjustment for known prognostic variables. Stratified randomization prevents the imbalance but cannot correct it post hoc.

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

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