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国际化学品安全规划署神经行为筛查方法合作研究:六、数据的一致性和可靠性

The IPCS Collaborative Study on Neurobehavioral Screening Methods: VI. Agreement and reliability of the data.

作者信息

Catalano P J, McDaniel K L, Moser V C

机构信息

Dana-Farber Cancer Institute, Boston, Massachusetts, USA.

出版信息

Neurotoxicology. 1997;18(4):1057-64.

PMID:9457734
Abstract

The IPCS Collaborative Study on Neurobehavioral Screening Methods was undertaken to determine the intra- and inter-laboratory reliability of a functional observational battery (FOB) and an automated assessment of motor activity in eight laboratories world-wide. The effects of seven chemicals (acrylamide, bis-acrylamide, p,p'-DDT, lead acetate, parathion, toluene, and triethyl tin) were studied during two dosing regimens: single-dose and four-week repeated dosing. All participating laboratories generally could detect and characterize the effects of known neurotoxicants, even though there were some differences in outcome on specific endpoints. The results were further evaluated to assess the agreement across laboratories in the dose-response data at the expected times of maximal effect (time of peak effect for the single-dose studies, and during or at the end of dosing for repeated-exposure studies). Percent agreement was calculated as the percentage of laboratories agreeing on an outcome (whether it be a significant dose effect or not). As an alternative approach, slopes of the dose-response functions were calculated, and reliability of those slope estimates across laboratories and chemicals was determined. Reliability was defined as the degree of agreement across laboratories (intraclass correlation coefficient) of the dose-response slopes within and between chemicals. These reliability estimates were calculated for each domain and for each endpoint. Relative reliability of the endpoints was evaluated, and hypotheses concerning the influence of outlying data were tested. The data clearly showed that reliability was not influenced by the objectivity or subjectivity of the test measure. Thus these data provide additional information regarding the reliability and robustness of the tests across the participating laboratories.

摘要

国际化学品安全规划署(IPCS)开展了神经行为筛查方法合作研究,以确定在全球八个实验室中,功能性观察组合测试(FOB)和运动活动自动评估的实验室内和实验室间可靠性。研究了七种化学品(丙烯酰胺、双丙烯酰胺、p,p'-滴滴涕、醋酸铅、对硫磷、甲苯和三乙基锡)在两种给药方案下的影响:单剂量给药和四周重复给药。尽管在特定终点的结果存在一些差异,但所有参与研究的实验室总体上都能检测到并描述已知神经毒物的影响。进一步评估结果,以评估各实验室在预期最大效应时间(单剂量研究的峰值效应时间,以及重复暴露研究给药期间或结束时)的剂量反应数据的一致性。一致性百分比计算为就某一结果达成一致的实验室百分比(无论该结果是否为显著剂量效应)。作为另一种方法,计算了剂量反应函数的斜率,并确定了这些斜率估计值在不同实验室和化学品之间的可靠性。可靠性定义为不同实验室之间(组内相关系数)化学品内部和之间剂量反应斜率的一致程度。针对每个领域和每个终点计算了这些可靠性估计值。评估了终点的相对可靠性,并检验了有关异常值数据影响的假设。数据清楚地表明,可靠性不受测试方法客观性或主观性的影响。因此,这些数据提供了有关参与研究的各实验室测试可靠性和稳健性的更多信息。

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