Quality of Life at Baseline: Is Assessment after Randomization Valid?

　

　　Author(s): Maria Mori Brooks, Louise S. Jenkins, Eleanor B. Schron, Jonathan S. Steinberg,Jean A. Cross and David S. Paeth

　　Source: Medical Care, Vol. 36, No. 10 (Oct., 1998), pp. 1515-1519

　　OBJECTIVES. The purpose of this report is to examine whether differences existed be-tween patients who completed a baseline quality of life (QoL) form before being in-formed about their randomized assignments versus those who completed it after knowing their randomization assignments. METHODS. In the pilot phase of the Antiar-rhythmics Versus Implantable Defibrillators (AVID) study (n = 200), 113 patients completed a baseline QoL battery prior to randomization (drug versus defibrillator), 49 additional pa-tients completed this battery after randomiza-tion, and 38 patients did not complete this battery. Baseline demographic, clinical and QoL data were compared for these groups. RESULTS. Although the two groups with QoL data were not significantly different re-garding various clinical and demographic characteristics, they did have significantly different QoL profiles. Patients with QoL col-lected before randomization had better over-all QoL scores and mental health scores. CONCLUSIONS. These data suggest that pa-tients with worse QoL may be less willing to complete a baseline QoL form in a timely manner or that knowledge of the randomi-zation assignment may have an effect on QoL.

　　Key words: quality of life; baseline data; pos-trandomization data.

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