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

项目摘要/摘要 美国有1200多家诊所在营销科学上未经证实的干细胞干预(SCI) 不受联邦监管和监督。不受监管的SCI对患者的一个主要风险是 被误导了。这导致数以万计的患者服用无规则的脊髓损伤，导致身体， 经济和情感上的伤害。我们患有慢性病的老龄化人口是干细胞的主要靶点 商业广告是一群独特的健康消费者，他们积极地在互联网上寻找信息 不受监管的情报来源，其错误信息经常被传播。我们的探索性项目，由NIH支持 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。至 到目前为止，还没有研究构建理论上知情的和经验上可靠的健康沟通干预措施 纠正错误信息并通过灌输对风险的适当警戒感来增强自主性 新的卫生干预措施，特别是那些在临床试验之外给予的干预措施。这项提议的总体目标是 创建并验证新的患者报告的新干预措施注意事项(NIC)措施，以评估 心理社会和行为决定因素(例如，感知的风险/收益、预期结果、行为 意图)参与新的干预措施，包括SCI。这一关键的衡量步骤将使 美国将测试未来旨在纠正(或接种)的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)发展概念性的 框架，以定义影响参与不受监管的SCI的结构之间的关系， 为NIC测量生成项目，并使用专家通过Delphi方法评估内容有效性 小组和患者的认知访谈；以及(2)评估NIC测量的心理测量学特性 检验维度、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，其中一个是我们以前已经确定并能够 成功招收病人。我们的工作将是第一次描绘出心理社会和行为 影响老年慢性病患者对不受监管的SCI的决定的决定因素。这项研究是 特别具有创新性，因为它将最先进的调查方法应用到一个新的主题领域--小说 干预措施，包括SCI。在完成这项建议后，我们将拥有所需的先决条件数据 结果衡量标准分布和试点后评估的必要部分，最终将在 更大规模的前瞻性随机试验R01应用。精心制作可信、突出的信息，有效地 反击有关不受监管的SCI的错误信息并引发对高风险干预的谨慎将有助于 解决日益老龄化的医疗保健消费者群体的未得到满足的需求。

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.