Creation of the Novel Interventions Caution (NIC) Measure to Assess Patient Behavior Towards Unregulated Stem Cell Interventions

项目概要/摘要 美国有超过1,200家诊所在销售未经科学证实的干细胞干预（SCI）。 不受联邦监管不受监管的SCI对患者的一个主要风险是 错误的消息这导致成千上万的患者服用不受管制的SCI， 经济和情感上的伤害我们的老龄人口与慢性疾病是干细胞的主要目标 是一个独特的健康消费者群体，他们积极地在互联网上寻找信息， 不受监管的SCI，经常发布错误信息。我们的探索性，NIH支持的 研究旨在评估患者对不受监管的SCI的信念和行为，以及 影响他们对信息可信度的看法，以创建试点卫生传播干预措施。到 迄今为止，还没有研究构建出有理论依据且经验可靠的健康传播干预措施 通过对风险注入适当的谨慎意识来纠正错误信息并增强自主性 新的健康干预措施，特别是那些在临床试验之外给予的干预措施。该提案的总体目标是 创建并确认新的患者报告的新型干预注意（NIC）措施，以评估 心理社会和行为决定因素（例如，感知风险/收益、预期结果、行为 参与新干预措施的意图，包括SCI。这一关键的测量步骤将定位 我们将测试未来健康传播干预措施的有效性， 反对）关于不受监管的SCI的错误信息。我们的两个具体目标是（1）发展概念 定义影响参与不受监管的SCI的结构之间关系的框架， 生成NIC测量项目，并使用专家通过德尔菲方法评估内容效度 小组和患者认知访谈;（2）评估NIC测量的心理测量学特性 检查维度，内部一致性信度和收敛效度。该措施将被发送到 参与者使用两个国家数据库，其中一个我们以前已经描述并能够 成功招募患者。我们的工作将是第一个描绘心理社会和行为 影响老年慢性病患者对不受监管的SCI决策的决定因素。本研究是 特别创新，因为它将最先进的调查方法应用于一个新的主题领域-小说 包括SCI在内的干预措施。在完成这项建议后，我们将获得所需的先决条件数据， 结果衡量分配和必要的部分，为试点前后评价，将最终在一个 大型前瞻性随机试验R 01应用。精心制作可信的、突出的信息， 反驳关于不受监管的SCI的错误信息，并对风险干预提出警告， 解决日益老龄化、共病的医疗保健消费者群体的未满足需求。

Project Summary/Abstract There are over 1,200 clinics in the U.S. marketing scientifically unsubstantiated stem cell interventions (SCIs) outside federal regulation and oversight. One major risk to patients from unregulated SCIs is the harm of being misinformed. This has led tens of thousands of patients to take an unregulated SCI resulting in physical, financial, and emotional harm. Our aging population with chronic diseases is the main target of stem cell commercials and are a unique group of health consumers who actively seek information on the internet for unregulated SCIs, for which misinformation is frequently promulgated. Our exploratory, NIH-supported research aims to evaluate patient beliefs and behaviors towards unregulated SCIs and the factors that influence their views on the credibility of information to create pilot health communication interventions. To date, no research has constructed theory-informed and empirically-robust health communication interventions that correct misinformation and enhance autonomy by infusing an appropriate sense of caution toward risky novel health interventions, particularly those given outside of a clinical trial. The overall goal this proposal is to create and validate a new patient-reported Novel Interventions Caution (NIC) measure to assess the psychosocial and behavioral determinants (e.g., perceived risks/benefits, expected outcomes, behavioral intent) of participation toward novel interventions, including SCIs. This crucial measurement step will position us to test the effectiveness of future health communication interventions aimed at correcting (or inoculating against) misinformation about unregulated SCIs. Our two specific aims are (1) to develop the conceptual framework to define the relationship among constructs that influence participation in unregulated SCIs, generate items for the NIC measure, and assess content validity through a Delphi approach using an expert panel and patient cognitive interviews; and (2) to assess the psychometric properties of the NIC measure examining dimensionality, internal consistency reliability, and convergent validity. The measure will be sent to participants using two national databases, including one we have previously characterized and been able to successfully recruit patients. Our work will be the first to delineate the psychosocial and behavioral determinants that influence older, chronic disease patient decisions about unregulated SCIs. This research is particularly innovative because it applies state-of-the-art survey methodology to a new topic area – novel interventions including SCIs. Upon completion of this proposal, we will have the required prerequisite data on outcome measure distributions and necessary pieces for a pilot pre-post evaluation that will culminate in a larger, prospective randomized trial R01 application. Crafting credible, salient messages that effectively counter misinformation about unregulated SCIs and elicit caution towards risky interventions will serve to address the unmet needs of a growing aging, comorbid group of health care consumers.