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BIOSTATISTICS
Year : 2011  |  Volume : 2  |  Issue : 3  |  Page : 109-112

Intention-to-treat concept: A review


Clinical Pharmacologist, Gurgaon, India

Correspondence Address:
Sandeep K Gupta
J-1044, First Floor, Palam Vihar, Gurgaon - 122 001, Haryana
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/2229-3485.83221

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Randomized controlled trials often suffer from two major complications, i.e., noncompliance and missing outcomes. One potential solution to this problem is a statistical concept called intention-to-treat (ITT) analysis. ITT analysis includes every subject who is randomized according to randomized treatment assignment. It ignores noncompliance, protocol deviations, withdrawal, and anything that happens after randomization. ITT analysis maintains prognostic balance generated from the original random treatment allocation. In ITT analysis, estimate of treatment effect is generally conservative. A better application of the ITT approach is possible if complete outcome data are available for all randomized subjects. Per-protocol population is defined as a subset of the ITT population who completed the study without any major protocol violations.


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