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: 10684297
• 负责人: Minji K Lee
• 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 2025-04-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10684297
• 关键词: Address; Advertisements; Advertising; 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; 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; Psychosocial Assessment and Care; 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; effectiveness evaluation; effectiveness testing; exhaust; health communication; innovation; interest; novel; older patient; permissiveness; prospective; psychosocial; randomized trial; stem cells; theories; web site; Address; Advertisements; Advertising; 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; 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; Psychosocial Assessment and Care; 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; effectiveness evaluation; effectiveness testing; exhaust; health communication; innovation; interest; novel; older patient; permissiveness; 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.

项目摘要/摘要 美国市场营销上有超过1,200个诊所，从科学上讲，干细胞干预措施（SCIS） 在联邦法规和监督之外。不受管制的SCI的患者的一个主要风险是危害 误导了。这导致成千上万的患者服用不受管制的SCI，导致身体 财务和情感伤害。我们患有慢性疾病的人口老龄化是干细胞的主要目标 广告，是一群独特的健康消费者，他们积极在互联网上寻求信息 不受管制的SCI，经常为此颁布了未经管辖权。我们的探索性NIH支持 研究旨在评估患者对不受管制的SCI的信念和行为以及这些因素 影响他们对信息的信誉的看法，以创建飞行员健康交流干预措施。到 日期，没有研究构建理论知觉且经验上的健康交流干预措施 通过对风险的适当谨慎感，正确的错觉并增强了自主权 新颖的健康干预措施，尤其是在临床试验之外进行的新干预措施。该提议的总体目标是 创建并验证新的患者报告的新型干预措施（NIC），以评估 社会心理和行为决定者（例如，感知的风险/收益，预期结果，行为 参与新干预措施的意图，包括SCIS。这个关键的测量步骤将定位 我们要测试旨在纠正（或接种）的未来健康交流干预措施的有效性 反对）对不受管制的SCI的错误信息。我们的两个具体目标是（1）发展概念 定义影响参与不管制的SCI的构造之间的关系的框架， 生成NIC测量的项目，并使用专家通过Delphi方法评估内容有效性 面板和患者认知访谈； （2）评估NIC测量的心理测量特性 检查维数，内部一致性可靠性和收敛性。测量将发送到 参与者使用两个国家数据库，其中包括我们以前已经表征的一个数据库，并且能够 成功招募患者。我们的工作将是第一个描绘社会心理和行为的工作 确定影响较老的慢性病患者对不受管制的SCI的决定。这项研究是 特别是创新的，因为它将最先进的调查方法应用于新主题领域 - 新型 包括SCIS在内的干预措施。该提案完成后，我们将获得有关的必需品数据 结果度量分布和试点前评估的必要片段，该评估将在 较大的前瞻性随机试验R01应用。制作可信，显着的消息，有效 关于不受管制的SCI的反对事实并引起对危险干预措施的谨慎将有助于 满足不断增长的衰老，合并症的卫生保健消费者的需求。