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评估随机试验中干预效果的替代方法:在结直肠癌筛查研究中的应用。

Alternative approaches to assessing intervention effectiveness in randomized trials: application in a colorectal cancer screening study.

机构信息

School of Public Health and Jonsson Comprehensive Cancer Center, University of California, Los Angeles, 650 Charles Young Dr. South, A2-125 CHS, Box 956900, Los Angeles, CA 90095-6900, USA.

出版信息

Cancer Causes Control. 2011 Sep;22(9):1233-41. doi: 10.1007/s10552-011-9793-9. Epub 2011 Jun 16.

Abstract

BACKGROUND

Previous analysis of a randomized community-based trial of a multi-component intervention to increase colorectal cancer (CRC) screening among Filipino Americans (n = 548) found significantly higher screening rates in the two intervention groups compared to the control group, when using intent-to-treat analysis and self-reported screening as the outcome. This report describes more nuanced findings obtained from alternative approaches to assessing intervention effectiveness to inform future intervention implementation.

METHODS

The effect of the intervention on CRC screening receipt during follow-up was estimated using methods that adjusted for biases due to missing data and self-report and for different combinations of intervention components. Adjustment for self-report used data from a validation substudy. Effectiveness within demographic subgroups was also examined.

RESULTS

Analyses accounting for self-report bias and missing data supported the effectiveness of the intervention. The intervention was also broadly effective across the demographic characteristics of the sample. Estimates of the intervention effect were highest among participants whose providers received a letter as part of the intervention.

CONCLUSIONS

The findings increase confidence that the intervention could be broadly effective at increasing CRC screening in this population. Subgroup analyses and attempts to deconstruct multi-component interventions can provide important information for future intervention development, implementation, and dissemination.

摘要

背景

先前对一项多组分干预措施的随机社区试验的分析显示,在菲律宾裔美国人(n=548)中,与对照组相比,两种干预组的结直肠癌(CRC)筛查率显著更高,该分析采用意向治疗分析和自我报告的筛查作为结果。本报告描述了从评估干预效果的替代方法中获得的更细微的发现,以提供未来干预实施的信息。

方法

使用调整因数据缺失和自我报告以及干预成分不同组合而产生的偏差的方法,估计干预对随访期间 CRC 筛查结果的影响。对自我报告的调整使用了验证子研究的数据。还检查了在人口统计学亚组内的有效性。

结果

考虑到自我报告偏差和缺失数据的分析支持了干预的有效性。该干预在样本的人口统计学特征方面也具有广泛的有效性。在作为干预一部分收到信件的提供者的参与者中,干预效果的估计值最高。

结论

这些发现增加了对该干预措施在该人群中广泛提高 CRC 筛查率的信心。亚组分析和尝试解构多组分干预措施可以为未来的干预措施的开发、实施和传播提供重要信息。

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