Rosen Laura J, Manor Orly, Brody David L, Engelhard Dan, Shtarkshall Rony A, Zucker David
Department of Health Promotion, School of Public Health, Tel Aviv University, Ramat Aviv, Israel.
Prev Med. 2009 Aug;49(1):12-8. doi: 10.1016/j.ypmed.2009.03.010. Epub 2009 Mar 13.
To propose a scheme for comprehensive development and evaluation of lifestyle interventions.
We adapted the four-phase system used in drug development, the engine of progress in medicine for decades, to construct a system for developing lifestyle intervention programs.
Phase I: The intervention is constructed and tested with a small number of individuals. Acceptability and feasibility are assessed. Evaluation is primarily qualitative. Phase II: Effectiveness on intermediate endpoints (e.g. behavior) is tested in a real field setting, with a limited number of individuals, using a before-and-after design. An iterative process of testing and refinement may be necessary. Phase III: The effectiveness of the intervention on health-related outcomes is tested, using, where possible, a randomized design. Phase IV: Large-scale implementation and penetration are assessed in other populations. Process variables and local and national health indicators are studied. The development and evaluation of our hygiene intervention, which took place in Jerusalem from 1999 to 2001, is presented as a case study.
Adaptation of the phased system of drug development to lifestyle interventions is a conceptually simple approach to building effective, sustainable programs for community-based public health.
提出一种生活方式干预综合开发与评估方案。
我们采用了药物开发中使用的四阶段系统（数十年来医学进步的引擎）来构建生活方式干预项目开发系统。
第一阶段：干预措施在少数个体中构建并测试。评估可接受性和可行性。评估主要是定性的。第二阶段：在实际现场环境中，对有限数量的个体，采用前后设计测试对中间终点（如行为）的有效性。可能需要进行测试和改进的迭代过程。第三阶段：尽可能采用随机设计，测试干预对健康相关结局的有效性。第四阶段：在其他人群中评估大规模实施和推广情况。研究过程变量以及地方和国家健康指标。我们于1999年至2001年在耶路撒冷开展的卫生干预的开发与评估作为案例研究呈现。
将药物开发的分阶段系统应用于生活方式干预是一种概念上简单的方法，可用于构建有效的、可持续的社区公共卫生项目。
