Can Consumers and Audiologists Detect Ear Disease Prior to Hearing Aid Use?

消费者和听力学家可以在使用助听器之前检测耳部疾病吗？

• 批准号: 9341926
• 负责人: Sumitrajit Dhar
• 金额: $ 57.04万
• 依托单位: NORTHWESTERN UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-09-17 至 2020-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9341926
• 关键词: Address; Adult; Audiology; Audiometry; Biometry; Clinic; Clinical; Conflict (Psychology); Data; Data Analyses; Data Analytics; Decision Making; Detection; Development; Diagnosis; Disease; Disease model; Ear; Ear Diseases; Ensure; Epidemiology; Equilibrium; Evaluation; Exercise; Funding; Health Personnel; Health Policy; Healthcare; Hearing; Hearing Aids; Institution; Judgment; Measures; Medical; Methods; National Institute on Deafness and Other Communication Disorders; Outcome; Patients; Phase; Physicians; Policies; Population; Predictive Value; Prevalence; Provider; Public Health; Questionnaire Designs; Questionnaires; Receiver Operating Characteristics; Regulation; Relative Risks; Risk; Risk Assessment; Risk Factors; Safety; Seeds; Sensitivity and Specificity; Signs and Symptoms; Site; Specialist; Structure; Sum; Surveillance Methods; Symptoms; Testing; Training; Translating; United States; United States Food and Drug Administration; Walkers; Work; analytical tool; base; cost; cost effective; design; disorder risk; experience; falls; field study; health care service; innovation; multidisciplinary; performance tests; prospective; prototype; public health relevance; screening; tool; waiver

DESCRIPTION (provided by applicant): Current United States Food and Drug Administration (FDA) policies for adults seeking to purchase hearing aids balance two potentially conflicting healthcare objectives: (1) ensure public safety by detecting sinister ear disease prior to hearing aid purchase, and (2) make hearing aids and other hearing healthcare services more affordable and available. Two disease surveillance policies have evolved, reflecting this dichotomy. The FDA preferred surveillance method requires that consumers obtain a pre-hearing aid purchase medical evaluation. This is assumed to provide optimal disease detection - at the potential cost of decreased affordability and availability of hearing healthcare services. Although formally discouraged, consumers can waive the medical evaluation, thereby potentially increasing accessibility of hearing healthcare services - at the potential cost of missing sinister ear diseas. The two FDA provisions are contradictory and there is little empirical evidence to support either as an effective public health policy or to inform alternative disease surveillance approaches. When the medical waiver option is exercised, the burden of detecting ear disease falls upon the consumer and the non-physician hearing healthcare provider (e.g. audiologist or hearing aid specialist) who provides the hearing aids. How well can audiologists detect ear disease? How well can consumers assess their own risk for ear disease? These two key questions must be addressed to answer the broader query posed by NIDCD: "Do the existing FDA requirements for medical evaluation and clearance prior to hearing aid procurement provide significant protection to patients or create a significant barrier to access?" We propose to empirically evaluate how well non-physicians (consumers and, in this case, audiologists) can evaluate ear disease risk, by developing and testing the performance of two questionnaire-based tools - one consumer focused (Consumer Ear Disease Risk Assessment or CEDRA) and one provider focused (Provider Ear Disease Risk Assessment or PEDRA). They are designed to be easy to complete, sensitive to ear disease risk factors, and result in a score that can be translated into statistical estimate of ear disease likelihood. CEDRA will consist of questions that focus on recognition of ear disease symptoms. PEDRA will include similar questions, and will also include innovative data analysis tools, developed at the Mayo Clinic, which enhance recognition of otologic disease risk factors in standard audiometric test data. The accuracy of CEDRA and PEDRA based disease screening will be evaluated against the judgments of otologists and neurotologists in a prospective, multisite study involving academic medical facilities across the United States. If CEDRA and PEDRA are found to accurately screen for ear disease, these tools might become useful to safely guide a consumer's decision to use the medical waiver - making hearing aids more affordable and accessible when disease risk is low. If ear disease cannot be detected using these tools under the optimal conditions of this study, the safety of the medical waiver option would have to be challenged.

描述（由申请人提供）：美国食品和药物管理局 (FDA) 针对寻求购买助听器的成年人的现行政策平衡了两个可能相互冲突的医疗保健目标：(1) 在购买助听器之前通过检测险恶的耳部疾病来确保公共安全，以及 (2) 使助听器和其他听力保健服务变得更加实惠和可用。两种疾病监测政策的发展反映了这种二分法。 FDA 首选的监测方法要求消费者在购买助听器前获得医疗评估。假设这可以提供最佳的疾病检测——但潜在的代价是听力保健服务的负担能力和可用性下降。尽管形式上不鼓励，但消费者可以放弃医疗评估，从而有可能增加听力保健服务的可及性——但代价是错过险恶的耳部疾病。 FDA 的两项规定是相互矛盾的，并且几乎没有经验证据支持作为有效的公共卫生政策或为替代疾病监测方法提供信息。当行使医疗豁免选项时，检测耳部疾病的负担就落在消费者和提供助听器的非医生听力保健提供者（例如听力学家或助听器专家）身上。听力学家能否很好地发现耳部疾病？消费者如何评估自己患耳病的风险？必须解决这两个关键问题，才能回答 NIDCD 提出的更广泛的问题：“FDA 在助听器采购之前对医疗评估和审批的现有要求是否为患者提供了重要的保护，还是对获取助听器造成了重大障碍？”我们建议通过开发和测试两种基于问卷的工具的性能来实证评估非医生（消费者，在本例中为听力学家）评估耳病风险的能力——一种以消费者为中心（消费者耳病风险评估或 CEDRA），一种以提供商为中心（提供商耳病风险评估或 PEDRA）。它们的设计易于完成，对耳病危险因素敏感，并产生可转化为耳病可能性统计估计的分数。 CEDRA 将包含侧重于识别耳部疾病症状的问题。 PEDRA 将包括类似的问题，还将包括梅奥诊所开发的创新数据分析工具，该工具可增强对标准听力测试数据中耳科疾病风险因素的识别。基于 CEDRA 和 PEDRA 的疾病筛查的准确性将根据耳科医生和神经科医生在一项涉及美国各地学术医疗机构的前瞻性多地点研究中的判断进行评估。如果发现 CEDRA 和 PEDRA 能够准确筛查耳部疾病，这些工具可能会有助于安全地指导消费者做出使用医疗豁免的决定，从而在疾病风险较低时使助听器变得更加实惠和容易获得。如果在本研究的最佳条件下使用这些工具无法检测到耳部疾病，则医疗豁免选项的安全性将不得不受到挑战。