Quality-of-life and behavioral outcome measures in randomized controlled trials of antiepileptic drugs: A systematic review of methodology and reporting standards

Purpose: To review the methodology and use of quality-of-life and behaviora l measures used in randomized controlled trials (RCTs) of antiepileptic dru gs in patients with epilepsy. Methods: Trial reports were found by searching a previously developed compr ehensive database of epilepsy RCTs and searching through journals by hand. inclusion and exclusion criteria were applied, and methodological and quali ty-of-life and behavioral measure data were extracted. Results: There were 52 different measures used in 46 trials, with the profi le of Mood States, the Minnesota Multiphasic Personality Inventory, and the Washington Psychosocial Seizure Inventory being applied the most frequentl y. Overall, evidence of the reliability, validity, and sensitivity of measu res 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 an d selection of measures without evidence of their appropriateness for use i n a population with epilepsy. We recommend the use of quality of-life and b ehavioral measures in RCTs with proven psychometric properties in a populat ion with epilepsy.