Assessment Tools for Contextual Factors in Interactions in CAM

描述(由申请人提供)：这项提案涉及与补充和替代医学(CAM)治疗相关的一个基本主题：我们如何衡量遭遇的背景？相遇被定义为患者从到达CAM实习点到离开时所经历的事情。这种遭遇可以分为两个部分：(A)主要治疗干预的经历(干预)和(B)干预本身之前、期间和之后的所有其他经历(背景)。情境效应在评估CAM干预措施的有效性和有效性方面发挥着两个关键作用。首先，语境效应可能会调节治疗效果的好坏(语境起到中介作用)。第二，背景效应实际上可能直接影响结果(背景即干预)。在经典的随机对照试验中，研究人员通常希望控制背景作为中介的影响，并测量背景作为干预的影响，以理清结果的哪一部分是由于干预，什么是由于背景。在CER中，研究人员不太关心控制语境作为调解人的影响，但他们想了解遭遇的哪些部分解释了任何积极的结果。无论是哪种情况，调查人员都必须知道如何衡量背景。如果没有这样的措施，就不可能评估这两种类型的背景影响。这项建议有3个具体目标：1.了解患者在与CAM接触期间接触到哪些背景因素？2.确定如何通过观察和/或患者和提供者回忆来可靠地测量这些背景因素；以及3.评估情境因素在(A)CAM模式(即，脊椎疗法与骨科疗法)；(B)实习地点、(C)提供者和(D)个别患者遇到的情况下可能存在的差异程度。本研究将以脊椎按摩接触作为CAM的范例，并开发一种快速的人种学观察方法来研究接触的背景。这个项目的目标是开发一种可靠、有效和严格的方法来收集有关背景的数据。拟议的研究解决了健康领域所有结果研究的一个基本问题：如何衡量背景对健康结果的影响。

DESCRIPTION (provided by applicant): This proposal addresses a fundamental topic relative to Complementary and Alternative Medicine (CAM) treatments: How do we measure the context of an encounter? Encounters are defined as what patients experience between when they arrive at a CAM practice site and when they leave. The encounter can be divided into two parts: (a) the experience of the main treatment intervention (the intervention) and (b) all other experiences before, during, and after the intervention itself (the context). Contextual effects play two critical roles in assessing the efficacy and effectiveness of CAM interventions. First, contextual effects may mediate how well a treatment works (context as mediator). Second, context effects may actually contribute to outcomes directly (context-as-intervention). In a classic RCT, investigators typically want to control for context-as-mediator effects and measure context-as-intervention effects to disentangle what portion of the results are due to the intervention and what are due to the context. In CER, investigators are less concerned about controlling for context-as-mediator effects, but they would like to understand what part of the encounter accounts for any positive results. In either case, investigators MUST know how to measure the context. Without such measures, it is impossible to assess either type of context effect. This proposal has 3 specific aims: 1. to understand what kinds of contextual factors patients are exposed to during CAM encounters? 2. To determine how to measure such contextual factors reliably via observation and/or patient and provider recall; and 3. To assess the degree to which contextual factors might vary within and across (a) CAM modalities (i.e., chiropractic versus osteopath); (b) practice sites, (c) providers, and (d) individual patient encounters This study will use the chiropractic encounter as an exemplar for CAM and develop a rapid ethnographic observation method to study the context of the encounter. The objective of this project is to develop a reliable, valid, and rigorous methodology for collecting data about the context. The proposed study addresses a fundamental issue of all outcome studies in health: how to measure the effect of the context on the health outcomes.