Moser V C, Becking G C, Cuomo V, Frantík E, Kulig B M, MacPhail R C, Tilson H A, Winneke G, Brightwell W S, De Salvia M A, Gill M W, Haggerty G C, Hornychová M, Lammers J, Larsen J J, McDaniel K L, Nelson B K, Ostergaard G
Neurotoxicology Division, U.S. Environmental Protection Agency, Research Triangle Park, North Carolina 27711, USA.
Neurotoxicology. 1997;18(4):947-67.
The goal of the International Programme on Chemical Safety (IPCS) Collaborative Study on Neurobehavioral Screening Methods was to determine the intra- and inter-laboratory reliability of a functional observational battery (FOB) and an automated assessment of motor activity in eight laboratories worldwide. The control data were crucial to the outcome of the studies in terms of sensitivity and reliability of the test measures, which in turn impact on the between-laboratory comparisons of chemical effects. In addition, analyses of control data can aid in determining endpoints that may require modification to improve their sensitivity and reliability. The control data from the eight laboratories were examined in terms of the following parameters: 1) control variability within studies for each laboratory; 2) within-laboratory replicability of control values across studies; 3) within-laboratory stability of control values over the course of testing for a given study; and 4) between-laboratory comparisons of parameters (1), (2), and (3). The analyses indicated considerable differences across endpoints, wherein some measures showed high variability and little replicability, while others were extremely reproducible. Generally, there were similar ranges of variability and replicability of control data across laboratories, although in some cases one or two laboratories were markedly different from the others. The physiological (weight, body temperature) and neuromuscular (grip strength, landing foot splay) endpoints exhibited the least variability, whereas the subjective assessments of reactivity varied the most. These data indicate a reasonable degree of comparability in the data generated in the participating laboratories.
国际化学品安全规划署(IPCS)神经行为筛查方法合作研究的目标是确定全球八个实验室中功能性观察组合(FOB)和运动活动自动评估的实验室内和实验室间可靠性。对照数据对于研究结果在测试指标的敏感性和可靠性方面至关重要,而这反过来又会影响化学效应的实验室间比较。此外,对照数据分析有助于确定可能需要修改以提高其敏感性和可靠性的终点。从以下参数方面对八个实验室的对照数据进行了检查:1)每个实验室研究内的对照变异性;2)各研究中对照值的实验室内可重复性;3)给定研究测试过程中对照值的实验室内稳定性;以及4)参数(1)、(2)和(3)的实验室间比较。分析表明各终点之间存在显著差异,其中一些指标显示出高变异性和低可重复性,而另一些则具有极高的可重复性。一般来说,各实验室对照数据的变异性和可重复性范围相似,尽管在某些情况下,有一两个实验室与其他实验室明显不同。生理指标(体重、体温)和神经肌肉指标(握力、落地脚展)的终点变异性最小,而反应性的主观评估变化最大。这些数据表明参与研究的实验室所产生的数据具有合理程度的可比性。