QUALITY-OF-LIFE AT BASE-LINE - IS ASSESSMENT AFTER RANDOMIZATION VALID

OBJECTIVES. The purpose of this report is to examine whether differenc es existed between patients who completed a baseline quality of life ( QoL) form before being informed about their randomized assignments ver sus those who completed it after knowing their randomization assignmen ts. METHODS. in the pilot phase of the Antiarrhythmics Versus Implanta ble Defibrillators (AVID) study (n = 200), 113 patients completed a ba seline QoL battery prior to randomization (drug versus defibrillator), 19 additional patients completed this battery after randomization, an d 38 patients did not complete this battery. Baseline demographic, cli nical and QoL data were compared for these groups. RESULTS. Although t he two groups with QoL data were not significantly different regarding various clinical and demographic characteristics, they did have signi ficantly different QoL profiles. Patients with QoL collected before ra ndomization had better overall QoL scores and mental health scores. CO NCLUSIONS. These data suggest that patients with worse QoL may be less willing to complete a baseline QoL form in a timely manner or that kn owledge of the randomization assignment may have an effect on QoL.