Compliance in the Study of Recent Recurrent Presumed Cerebral Emboli

Abstract

<p>The measurement of compliance is essential in clinical trials to assess the efficacy and side effects of treatment. Multiple methods of measuring compliance and several predictors of it are recognized. However, noncompliance has been defined using arbitrary "cutting" points on scales measuring compliance. Such cutting points should be validated against an external measurement.</p> <p>In the Study of Recent Recurrent Presumed Cerebral Emboli, multiple measurements affected by the drugs (which are meant to prevent such events) are available on multiple occasions in the same subjects. This thesis explores ways in which one can assess the extent to which these measurements agree as indices of the intake of those drugs. Furthermore, it explores how such measurements can be validated against an external measurement, the outcome desired (i.e. the control of cerebral emboli) in order to choose a valid "cutting point" to define compliance and non-compliance. Finally, it suggests methodologies to predict whether a subject will be compliant or non-compliant and to study whether compliance is a constant characteristic of certain subjects or (varies through time, being affected by time or various events in the course of therapy. Thus, this thesis proposes a methodology to obtain a valid index of compliance which will predict outcomes and a methodology to study the factors which predict such compliance.</p>