Rotem Ann, Danieli Yaron, Ben-Sheetrit Joseph, Bashari Amit, Golubchik Pavel, Ben-Hayun Rachel, Weizman Abraham, Manor Iris
Geha Mental Health Center, 1 Helsinki St, P.O. Box 102, 4910002, Petah Tikva, Israel.
Yissum Research Development Company, The Hebrew University of Jerusalem, Jerusalem, Israel.
Atten Defic Hyperact Disord. 2019 Mar;11(1):73-81. doi: 10.1007/s12402-018-0278-5. Epub 2019 Mar 29.
The test of variables of attention (TOVA) is a continuous performance test commonly used as an aid for diagnosis of ADHD and assessment of treatment response. It has been studied and standardized in both children and adults. As a repetitive measurement of treatment efficacy, used both in research and in the clinic, it's important to disprove a practice effect. A retrospective cohort analysis was done, using only the placebo-arm participants from two different randomized, multicenter, double-blind clinical trials on the efficacy of a non-stimulant (metadoxine-XR). In order to reveal the practice effects, only the participants that showed no placebo effect (< 25% improvement), in the Conners' Adult ADHD Rating Scale-investigator rated (CAARS-Inv), the gold standard, were included. Demographic data, CAARS-Inv baseline and TOVA results during each visit were recorded and analyzed. Ninety-one participants from two studies were pooled (2014 n = 24, 2016 n = 67). They did not differ significantly in any demographic parameter, most side effect frequencies, and CAARS-Inv baseline scores. The baseline TOVA performances demonstrated similarity in the degree of inattention, variability, impulsivity, and response time. The TOVA scores were not altered significantly between visits, as assessed by repeated-measures analysis of variance. No significant differences were detected between the TOVA baseline-to-endpoint scores as assessed by paired t test. No practice effects were detected, in both clinical trials, suggesting that the results of the TOVA are likely to represent genuine changes in attentional performance. Further studies are needed to replicate these findings.
注意力变量测试(TOVA)是一种连续操作测试,常用于辅助多动症的诊断和治疗反应评估。它已在儿童和成人中进行了研究并实现标准化。作为一种在研究和临床中都用于重复测量治疗效果的方法,反驳练习效应很重要。我们进行了一项回顾性队列分析,仅使用来自两项关于非兴奋剂(美他多辛缓释片)疗效的不同随机、多中心、双盲临床试验的安慰剂组参与者。为了揭示练习效应,仅纳入在康纳斯成人多动症评定量表-研究者评定版(CAARS-Inv)(金标准)中未显示安慰剂效应(改善<25%)的参与者。记录并分析了人口统计学数据、每次访视时的CAARS-Inv基线和TOVA结果。汇总了两项研究中的91名参与者(2014年n = 24,2016年n = 67)。他们在任何人口统计学参数、大多数副作用发生率和CAARS-Inv基线评分方面均无显著差异。基线TOVA表现显示在注意力不集中程度、变异性、冲动性和反应时间方面具有相似性。通过重复测量方差分析评估,访视之间TOVA分数没有显著变化。通过配对t检验评估,TOVA基线至终点分数之间未检测到显著差异。在两项临床试验中均未检测到练习效应,这表明TOVA的结果可能代表了注意力表现的真实变化。需要进一步的研究来重复这些发现。