Measuring antiepileptic therapies: the patient vs the physician viewpoint.

In clinical practice, clinicians use patients' views of treatment when making decisions about management. In clinical trials, however, the patient's perspective is largely ignored, and there has been a preference for "objective" measurements. It is important that clinical trials reflect clinical practice and are clinically relevant; thus, there is a need to include broader-based patient-assessed outcomes in clinical trials. Quality-of-life assessment has been widely applied and accepted in other chronic illnesses; however, standard health and quality-of-life measures might be insensitive to the unusual disabilities produced by epilepsy. A quality-of-life model has been used in order to develop novel measures of seizure severity, impact of epilepsy, and life fulfillment. These scales might add to the sensitivity of clinical trials of new antiepileptic drugs. This approach has been used in a study of lamotrigine and indicates that the drug has some positive effects on seizure severity, in addition to improving quality of life.