Henry David, Tolan Patrick, Gorman-Smith Deborah, Schoeny Michael
University of Illinois at Chicago, Chicago, IL, USA.
University of Virginia, Charlottesville, VA, USA.
Prev Sci. 2017 Aug;18(6):671-680. doi: 10.1007/s11121-016-0706-8.
Multiple factors may complicate evaluation of preventive interventions, particularly in situations where the randomized controlled trial (RCT) is impractical, culturally unacceptable, or ethically questionable, as can occur with community-based efforts focused on inner-city neighborhoods or rural American Indian/Alaska Native communities. This paper is based in the premise that all research designs, including RCTs, are constrained by the extent to which they can refute the counterfactual and by which they can meet the challenge of proving the absence of effects due to the intervention-that is, showing what is prevented. Yet, these requirements also provide benchmarks for valuing alternatives to RCTs, those that have shown abilities to estimate preventive effects and refute the counterfactual with limited bias acting in congruence with community values about implementation. In this paper, we describe a number of research designs with attending examples, including regression discontinuity, interrupted time series designs, and roll-out randomization designs. We also set forth procedures and practices that can enhance their utility. Alternative designs, when combined with such design strengths, can provide valid evaluations of community-based interventions as viable alternatives to the RCT.
多种因素可能会使预防性干预措施的评估变得复杂，尤其是在随机对照试验（RCT）不切实际、在文化上不可接受或在伦理上存在问题的情况下，就像针对美国内陆城市社区或美国印第安/阿拉斯加原住民农村社区开展的社区工作中可能出现的那样。本文基于这样一个前提，即所有研究设计，包括随机对照试验，都受到它们反驳反事实情况的程度以及应对证明干预措施不存在效果这一挑战（即表明预防了什么）的能力的限制。然而，这些要求也为评估随机对照试验的替代方案提供了基准，这些替代方案已显示出有能力估计预防效果，并以与社区实施价值观一致的有限偏差反驳反事实情况。在本文中，我们描述了一些研究设计并附上示例，包括回归间断设计、中断时间序列设计和推广随机化设计。我们还阐述了可以提高其效用的程序和做法。替代设计与这些设计优势相结合时，可以为基于社区的干预措施提供有效的评估，作为随机对照试验的可行替代方案。
