Quality‐of‐Life and Behavioral Outcome Measures in Randomized Controlled Trials of Antiepileptic Drugs: A Systematic Review of Methodology and Reporting Standards

Abstract

Summary: Purpose:To review the methodology and use of quality-of-life and behavioral measures used in randomized controlled trials (RCTs) of antiepileptic drugs in patients with epilepsy.Methods: Trial reports were found by searching a previously developed comprehensive database of epilepsy RCTs and searching through journals by hand. Inclusion and exclusion criteria were applied, and methodological and quality-of-life and behavioral measure data were extracted.Results: There were 52 different measures used in 46 trials, with the Profile of Mood States, the Minnesota Multiphasic Personality Inventory, and the Washington Psychosocial Seizure Inventory being applied the most frequently. Overall, evidence of the reliability, validity, and sensitivity of measures used in populations of people with epilepsy was sparse. There was also little information on the clinical interpretation of the results.Conclusion: Our results highlight a consistent failure to apply quality-of-life and behavioral measures in RCTs in a systematic way. We found repeated evidence of researchers' failure to review the use of previous measures and selection of measures without evidence of their appropriateness for use in a population with epilepsy. We recommend the use of qualityof-life and behavioral measures in RCTs with proven psychometric properties in a population with epilepsy. Key Words: Behavioral outcomes-Clinical trials-PsychologicalSystematic review.The ultimate goal in the management of epilepsy is not only cessation of seizures with minimal side effects but also an improvement in the patient's overall quality of life. However, only recently have quality-of-life and behavioral measures become recognized as relevant measures of the efficacy of particular treatment regimens (1).The evolution of behavioral and quality-of-life outcome measures in epilepsy, according to Hermann (Z), can be traced through three distinct phases. Phase one emphasized the importance of measuring intellectual functioning and the behavioral and emotional correlates of epilepsy; phase two focused on the development of epilepsy-specific psychological measures; and phase three was characterized by the development of diseasespecific instruments (1).In randomized clinical trials of novel antiepileptic drugs (AEDs), historically, the standard assessment of outcome has been the reduction in the frequency and Accepted June 19, 2000. Address correspondence and reprint requests to Dr. Gus A B k e r , Department of Neurological Science, Walton Centre for Neurology and Neurosurgery, Lower Lane, Liverpool L9 7LJ, United Kingdom. E-mail: baker-g@wcnn-tr.nwest.nhs.uk severity of seizures, although recently patient-based measures of behavior or quality of life have been specifically developed to assess the wider benefits of a particular treatment (3).These developments are welcome, given that one of the first trials to evaluate the behavioral effects of a randomized controlled trial (RCT) of a novel AED reported elevated mood effects and less fatigue using measures developed ...

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