A FRAMEWORK FOR THE DESIGN, CONDUCT AND INTERPRETATION OF RANDOMISED CONTROLLED TRIALS IN THE PRESENCE OF TREATMENT CHANGES

A framework for the design, conduct and interpretation of randomised controlled trials in the presence of treatment changes

Abstract Background When a randomised trial is subject to deviations from randomised treatment, analysis according to intention-to-treat does not estimate two important quantities: relative treatment efficacy and effectiveness in a setting different from that in the trial.Even in trials of a predominantly pragmatic nature, there may be numerous rea

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