Quality of life at baseline - Is assessment after randomization valid?
Quality of life at baseline - Is assessment after randomization valid?
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DOI：
10.1097/00005650-199810000-00009
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发表时间：
1998-10-01
期刊：
影响因子：
3
通讯作者：
Paeth, DS
中科院分区：
文献类型：
--
作者：
Brooks, MM;Jenkins, LS;Paeth, DS
目标。本报告的目的是检查在被告知随机分配之前完成基线生活质量（QoL）表格的患者与在知道随机分配后完成基线生活质量表格的患者之间是否存在差异。在抗心律失常与植入式除颤器（AVID）研究的试点阶段（n = 200）， 113名患者在随机化之前完成了基线生活质量电池（药物与除颤器），另外19名患者在随机化后完成了该电池，38名患者未完成该电池。比较两组的基线人口学、临床和生活质量数据。虽然两组的生活质量数据在各种临床和人口学特征方面没有显著差异，但他们的生活质量概况确实存在显著差异。随机化前收集的生活质量患者总体生活质量评分和心理健康评分较高。这些数据表明，生活质量较差的患者可能不太愿意及时完成基线生活质量表，或者了解随机分配可能对生活质量有影响。
OBJECTIVES. The purpose of this report is to examine whether differences existed between patients who completed a baseline quality of life (QoL) form before being informed about their randomized assignments versus those who completed it after knowing their randomization assignments.METHODS. in the pilot phase of the Antiarrhythmics Versus Implantable Defibrillators (AVID) study (n = 200), 113 patients completed a baseline QoL battery prior to randomization (drug versus defibrillator), 19 additional patients completed this battery after randomization, 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 regarding various clinical and demographic characteristics, they did have significantly different QoL profiles. Patients with QoL collected before randomization had better overall QoL scores and mental health scores.CONCLUSIONS. These data suggest that patients with worse QoL may be less willing to complete a baseline QoL form in a timely manner or that knowledge of the randomization assignment may have an effect on QoL.