Roy-Byrne Peter P, Sherbourne Cathy D, Craske Michelle G, Stein Murray B, Katon Wayne, Sullivan Greer, Means-Christensen Adrienne, Bystritsky Alexander
Department of Psychiatry and Behavioral Sciences, University of Washington at Harborview Medical Center, Seattle 98014, USA.
Psychiatr Serv. 2003 Mar;54(3):327-32. doi: 10.1176/appi.ps.54.3.327.
Recently the National Institutes of Health has been emphasizing research that takes findings generated by clinical research and translates them into treatments for patients who are seen in day-to-day nonresearch settings. This translational process requires a series of steps in which elements of both efficacy and effectiveness research are combined into successively more complex designs. However, there has been little discussion of exactly how to develop and operationalize these designs. This article describes an approach to the development of these hybrid designs. Their operationalization is illustrated by using the design of an ongoing effectiveness treatment study of panic disorder in primary care. Experts in both efficacy and effectiveness research collaborated to address the methodologic and data collection issues that need to be considered in designing a first-generation effectiveness study. Elements of the overall study design, setting or service delivery context, inclusion and exclusion criteria, recruitment and screening, assessment tools, and intervention modification are discussed to illustrate the thinking behind and rationale for decisions about these different design components. Although the series of decisions for this study were partly influenced by considerations specific to the diagnosis of panic disorder and the context of the primary care setting, the general stepwise approach to designing treatment interventions using an effectiveness model is relevant for the development of similar designs for other mental disorders and other settings.
最近，美国国立卫生研究院一直强调开展这样的研究：将临床研究产生的结果转化为针对日常非研究环境中患者的治疗方法。这个转化过程需要一系列步骤，在这些步骤中，疗效研究和效果研究的要素被整合到越来越复杂的设计中。然而，对于如何确切地开发和实施这些设计，几乎没有进行过讨论。本文描述了一种开发这些混合设计的方法。通过一项正在进行的初级保健中惊恐障碍有效性治疗研究的设计，来说明它们的实施过程。疗效研究和效果研究方面的专家共同协作，以解决在设计第一代效果研究时需要考虑的方法学和数据收集问题。讨论了总体研究设计、设置或服务提供背景、纳入和排除标准、招募和筛选、评估工具以及干预调整等要素，以说明关于这些不同设计组成部分的决策背后的思路和理由。尽管这项研究的一系列决策部分受到惊恐障碍诊断的特定考虑因素以及初级保健环境背景的影响，但使用效果模型设计治疗干预措施的一般逐步方法与为其他精神障碍和其他环境开发类似设计相关。
