Schölzel-Dorenbos Carla J M, van der Steen Mariëlle J M M, Engels Lotte K, Olde Rikkert Marcel G M
Memory Clinic Slingeland Hospital, Alzheimer Centre Nijmegen, University Medical Centre Nijmegen, the Netherlands.
Alzheimer Dis Assoc Disord. 2007 Apr-Jun;21(2):172-8. doi: 10.1097/WAD.0b013e318047df4c.
We conducted a systematic review of the use of quality of life (QoL) measures as outcome in pharmacological and nonpharmacologic intervention trials in patients with Mild Cognitive Impairment or dementia, and their proxies. Randomized controlled trials (RCTs) were identified from a search of the Specialized Register of the Cochrane Dementia and Cognitive Improvement Group in April 2006. We also checked references and systematic reviews. Primary and secondary end points were screened for QoL-scales, and it was registered whether information on responsiveness was provided. We found 117 pharmacologic and 108 nonpharmacologic RCTs. One of the pharmacologic and 4 of the nonpharmacologic studies used QoL as primary outcome, and 2 and 3, respectively, as secondary end point. Altogether QoL was assessed in only 10 (4.4%) of these RCTs, of which 2 reported on responsiveness of QoL. This review provides evidence that QoL-instruments are seldom used as outcome measures in RCTs in dementia and Mild Cognitive Impairment, and that information on responsiveness is scarce. QoL-measures should be applied more often in clinical trials, as currently no disease modifying drugs are available, although there are valid and reliable QoL-measures for dementia that reflect the aims of palliative care and provide transparent information about patient's and caregiver's treatment benefits. We recommend further research efforts aimed at the determination of the minimal important difference in QoL-scales and the responsiveness of QoL-scales. Subsequently, QoL should be measured as relevant end point, both in patients and their proxies, in all clinical trials in dementia.
我们对生活质量（QoL）测量作为轻度认知障碍或痴呆患者及其替代者的药物和非药物干预试验结果的应用进行了系统评价。通过检索2006年4月Cochrane痴呆与认知改善小组的专业注册库，确定了随机对照试验（RCT）。我们还查阅了参考文献和系统评价。对主要和次要终点进行了QoL量表筛查，并记录是否提供了有关反应性的信息。我们发现了117项药物RCT和108项非药物RCT。其中1项药物研究和4项非药物研究将QoL作为主要结局，分别有2项和3项将其作为次要终点。在这些RCT中，总共只有10项（4.4%）评估了QoL，其中2项报告了QoL的反应性。本评价提供的证据表明，在痴呆和轻度认知障碍的RCT中，QoL工具很少用作结局指标，且有关反应性的信息匮乏。由于目前尚无疾病修饰药物，而有有效且可靠的痴呆QoL测量方法可反映姑息治疗的目标并提供有关患者和护理人员治疗益处的透明信息，因此QoL测量应更频繁地应用于临床试验。我们建议进一步开展研究，以确定QoL量表的最小重要差异和QoL量表的反应性。随后，在所有痴呆临床试验中，应将QoL作为患者及其替代者的相关终点进行测量。
