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特邀评论:对于行为修正试验(例如饮食或运动干预),能否采用硬性终点?

Invited Commentary: Can You Do Trials of Behavioral Modification, Such as Diet or Exercise Intervention, With Hard Endpoints?

出版信息

Am J Epidemiol. 2020 Jun 1;189(6):499-502. doi: 10.1093/aje/kwz256.

DOI:10.1093/aje/kwz256
PMID:31712818
Abstract

Blackburn (Am J Epidemiol. 2020;189(6):491-498) describes the evolution from the Makarska Conference in 1968 to the planning of the JUMBO trial and the decision by the National Institutes of Health (NIH) to do the Multiple Risk Factor Intervention Trial. He attributes the failure of the Multiple Risk Factor Intervention Trial to show a significant reduction in coronary heart disease or total mortality to the design of the trial, the multiple centers involved, and continued bureaucracy. The paper is important in raising 3 issues of continued relevance: 1) What is the relationship of the NIH staff in both development and monitoring of large cooperative studies, especially clinical trials, outside of the walls of the NIH? 2) Can clinical trials that utilize individual randomization to intervention and comparison be successful in evaluating a common-source epidemic, such as diet and coronary heart disease, especially in populations with readily available foods and competing advertising, etc.? 3) How much information obtained from, e.g., observational studies, animal models, and genetic studies, is necessary given limits of human population clinical trials of behavioral intervention to develop recommendations for strong public health programs to reduce morbidity and mortality, and what is the measure of successful intervention?

摘要

布莱克本(美国流行病学杂志。2020;189(6):491-498)描述了从 1968 年的马卡尔斯卡会议到 JUMBO 试验的规划以及美国国立卫生研究院(NIH)决定进行多项危险因素干预试验的演变。他将多项危险因素干预试验未能显示冠心病或总死亡率有显著降低归因于试验设计、涉及的多个中心以及持续的官僚主义。这篇论文提出了三个仍然相关的问题:1)NIH 工作人员在 NIH 墙外参与大型合作研究(特别是临床试验)的发展和监测方面的关系是什么?2)利用个体随机化进行干预和比较的临床试验,能否成功评估饮食与冠心病等常见来源的流行病,特别是在可获得现成食物和竞争广告等的人群中?3)考虑到人群临床试验中行为干预的人类人口限制,从观察性研究、动物模型和遗传研究中获得的信息量是多少,以及减少发病率和死亡率的强有力公共卫生计划的建议的成功干预措施是什么?

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