Operational design and quality control in the CATCH multicenter trial
Operational design and quality control in the CATCH multicenter trial
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DOI：
10.1006/pmed.1996.0071
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发表时间：
1996-07-01
影响因子：
5.1
通讯作者：
Elder, JP
中科院分区：
文献类型：
--
作者：
Stone, EJ;Osganian, SK;Elder, JP
背景资料。儿童和青少年心血管健康试验(CATCH)是第一个采用临床试验基本原理的多中心校本研究，包括标准化的操作规程和手册、研究管理的指导委员会、分布式数据系统、广泛的质量控制系统以及数据和安全监测委员会。CATCH测试了学校午餐、体育课、吸烟政策、课程和家庭活动变化的有效性。四个州的96所小学被随机分配到干预或控制条件下。基线队列包括5106名不同种族的三年级学生，一直跟踪到五年级。与对照组相比，干预学校午餐中来自脂肪和饱和脂肪的卡路里百分比显著降低。现有体育课的中等到剧烈的活动水平也有了显着的提高。自我报告的饮食、体力活动和心理社会措施的变化是显著的。生理指标无显著差异。除皮褶外，所有生理指标的测量误差普遍较低，表明可靠性水平很高。在所有地点，血脂、身高和体重的变异系数不到3%，而皮褶的变异系数则相当高，从6%到8%不等。血脂研究的组内相关性也一致很高，为0.99。在观察到的11项活动中，有9项观察者之间的一致性得分大于90%。数据录入错误率很低，所有表格每千个字段中的错误数不到5个。人口普查结果提供了更多的科学证据，证明学校在促进健康的人口方法中的重要性。在这项复杂的多中心试验中，在设计和分析、测量、培训、数据管理和质量控制方案方面使用的许多策略可能适用于其他研究。(C)1996年学术出版社。
Background. The Child and Adolescent Trial for Cardiovascular Health (CATCH) was the first multicenter school-based research study to employ the fundamentals of clinical trials including the standardized protocol and Manuals of Operation, a steering committee for study governance, a distributed data system, an extensive quality control system, and a Data and Safety Monitoring Board.Method. CATCH tested the effectiveness of changes in school lunches, physical education, smoking policy, curricula, and family activities. Ninety-six elementary schools in four states were randomized to intervention or control conditions. The baseline cohort comprised 5,106 ethnically diverse third graders followed through fifth grade.Results. The percentages of calories from fat and saturated fat were reduced significantly more in the intervention school lunches than among the controls. Significant increases in moderate to vigorous activity levels in existing physical education classes mere made as well. Changes in self-reported dietary, physical activity, and psychosocial measures were significant. There were no significant differences in the physiological measures. Measurement error was generally low for all physiologic measures except skinfolds, indicating a high level of reliability. Across all sites, the coefficients of variation for lipids, height, and weight were less than 3%, whereas for skinfolds, they were considerably higher, ranging from 6 to 8%. Intraclass correlations for Lipid studies were also uniformly high at 0.99. Interobserver agreement scores for SOFIT were greater than 90% for 9 of the 11 activities observed. Data entry error rates were low with less than five errors per 1,000 fields for all forms.Conclusions. The CATCH results provided more scientific evidence on the importance of schools in the population approach to health promotion. Many of the strategies used in this complex multicenter trial in the areas of design and analysis, measurement, training, data management, and quality control protocols might be appropriate for adoption in other studies. (C) 1996 Academic Press, Inc.