Intention to treat analysis is often inadequate

Many authors reporting intention to treat analyses have incorrectly dealt with deviations from randomisation and missing data. Intention to treat is commonly used in analysis of randomised controlled trials to estimate the benefit of a change in treatment policy rather than the potential benefit in patients who receive the planned treatment. Hollis and Campbell (p 670) surveyed reports of randomised controlled trials in four major medical journals in 1997. About half had used intention to treat analysis, but many had incorrectly excluded patients who had not received the randomised treatment or had missing outcome data. The authors make recommendations for design, conduct, analysis, and reporting of studies using intention to treat analysis.

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Relevant Article

What is meant by intention to treat analysis? Survey of published randomised controlled trials

Sally Hollis and Fiona Campbell
BMJ 1999 319: 670-674. [Abstract] [Full Text] [PDF]