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

创建新型干预警告 (NIC) 措施来评估患者对不受监管的干细胞干预的行为

• 批准号: 10507963
• 负责人: Zubin Master
• 金额: $ 7.95万
• 依托单位: MAYO CLINIC ROCHESTER
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-01 至 2024-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10507963
• 关键词: Address; Advertisements; Age-Years; Aging; Alzheimer' s Disease; American; Area; Attitude; Behavior; Behavioral; Belief; Benefits and Risks; Cause of Death; Cessation of life; Chronic Disease; Clinic; Clinical Trials; Communication Tools; Consensus; Data; Databases; Degenerative polyarthritis; Dementia; Dimensions; Economics; Effectiveness; Elderly; Emotional; Ensure; Environment; Epidemic; Evaluation; Factor Analysis; Future; Generations; Goals; Health; Healthcare; Heart Diseases; Hypertension; Injury; Institution; International; Internet; Intervention; Knowledge; Lead; Lung diseases; Marketing; Measurement; Measures; Medical; Medicine; Misinformation; Morbidity - disease rate; Obesity; Outcome; Outcome Measure; Participant; Patient Participation; Patient Recruitments; Patients; Positioning Attribute; Procedures; Property; Psychometrics; Regulation; Reporting; Research; Research Support; Resistance; Risk; Safety; Science; Source; Stroke; Survey Methodology; Translations; Trust; United States National Institutes of Health; Work; aging population; burden of illness; cognitive interview; comorbidity; cost; data format; effectiveness evaluation; effectiveness testing; exhaust; health communication; innovation; interest; novel; older patient; prospective; psychosocial; randomized trial; stem cells; theories; web site

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.

项目概要/摘要 美国有超过 1,200 家诊所在营销未经科学证实的干细胞干预 (SCI) 不受监管的 SCI 给患者带来的一大风险是受到联邦监管和监督之外的伤害。 这导致数以万计的患者接受了不受监管的 SCI，导致身体、 患有慢性疾病的老龄化人口是干细胞的主要目标。 广告，是一个独特的健康消费者群体，他们积极在互联网上寻找信息以获取健康信息 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。 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其发生的因素 影响他们对信息可信度的看法，以制定试点健康传播干预措施。 迄今为止，还没有研究构建基于理论和实证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权 新颖的健康干预措施，特别是在临床试验之外进行的干预措施，该提案的总体目标是。 创建并验证新的患者报告的新型干预措施（NIC）来评估 社会心理和行为决定因素（例如，感知的风险/收益、预期结果、行为 参与新干预措施（包括 SCI）的这一关键衡量步骤将定位。 我们测试未来旨在纠正（或预防）健康传播干预措施的有效性 反对）有关不受监管的 SCI 的错误信息。我们的两个具体目标是 (1) 发展概念。 框架来定义影响不受监管的 SCI 参与的结构之间的关系， 生成 NIC 衡量项目，并由专家通过 Delphi 方法评估内容有效性 小组和患者认知访谈；(2) 评估 NIC 测量的心理测量特性 检查维度、内部一致性可靠性和收敛有效性。 参与者使用两个国家数据库，其中一个我们之前已经描述过并能够 我们的工作将首先描述患者的心理社会和行为。 影响老年慢性病患者对不受监管的 SCI 做出决定的决定因素。 特别创新，因为它将最先进的调查方法应用于新的主题领域——新颖 包括 SCI 在内的干预措施完成后，我们将获得所需的先决数据。 结果衡量分布和试点事前评价的必要部分，最终将产生 更大规模的前瞻性随机试验 R01 应用程序 有效地制作可信的、显着的信息。 反驳有关不受监管的 SCI 的错误信息，并引起对危险干预措施的警惕，将有助于 解决日益增长的老龄化、共病医疗保健消费者群体未得到满足的需求。