Development and Validation of an Instrument to Assess Cognitive Function Regulati

描述（由申请人提供）：认知障碍是一个严重的公共问题，影响超过三分之一的71岁及以上的美国人。认知功能受损会损害与牙齿相关的功能（例如，做出治疗决定、进行口腔卫生护理和遵循家庭护理指示），显著增加患龋齿、牙周病和其他口腔健康问题的风险。口腔健康状况不佳与糖尿病有关，并增加心血管疾病和复发性呼吸道感染的风险，这是特殊需要患者死亡的主要原因。目前，由于缺乏可靠和实用的方法，DRF评估不是牙科评估和治疗计划的标准部分。这一事实可能会影响护理质量，并增加可避免并发症的风险。针对这一未被满足的需求，陈曦博士（PI）提出了一项职业发展计划，以开发一种评估认知受损患者DRF的工具。陈医生是为数不多的接受过奖学金培训的老年牙医之一，拥有丰富的研究基础。他在明尼苏达大学完成了老年牙科奖学金和健康信息学博士培训，并于2008年在北卡罗来纳大学教堂山分校（UNC-CH）担任助理教授，开始了他的职业生涯。他在老年牙科，老年学和临床研究方面的独特背景，以及对推进老年牙科领域的强烈热情和职业责任感，使他成为该奖项的杰出候选人。在过去的三年中，UNC-CH为陈博士提供了启动资金，保护时间等优秀的支持，使他能够组建多学科的指导团队，并完成了多项初步研究，对拟研究的假设进行概念化和检验。一个原型仪器也已经开发出来，现在准备进行进一步的测试。所有这些因素都使陈医生成为老年牙科研究的独立调查员。拟议的职业发展计划包括监督学习和指导研究，这将增加Dr. Chen以前的培训，补充他拟议的研究，并发展所需的专业知识，以促进他过渡到一个独立的老年牙科研究员。拟议的培训计划包括教学（例如认知神经科学、认知功能评估和测量设计、流行病学和统计）、临床和研究研讨会，以及北卡大学神经病学诊所有监督的临床轮转。在此期间，陈博士将每隔一周与他的导师会面一次，讨论拟议的研究，培训和其他职业发展问题。这些培训活动旨在帮助陈医生：A)为认知障碍患者发展认知和功能评估方面的专业知识；B)发展健康测量量表开发和验证方面的专门知识；C)提高临床研究技能。作为培训计划的补充，指导研究计划旨在提高陈医生的临床研究技能，并提供以患者为导向的牙科研究经验，所有这些都是实现他的长期目标——为痴呆症患者开发一种新的循证牙科护理模式所必需的。提出的研究计划是他实现长期目标的重要一步，可以分为两个阶段。第一阶段是完善拟议的牙齿相关功能测试（DRF-Test）（具体目标1）。通过文献回顾和焦点小组讨论，PI开发了包含17个项目的drf测试原型。进行两项内容效度测试，一项由老年牙科执业专家进行，另一项由老年认知/功能评估专家进行，并进行实地测试。这些结果将用于进一步完善原型仪器。drf测试的心理测量特性将在第二阶段进行评估（具体目标2）。将对200名轻度认知障碍或痴呆患者进行drf测试和标准认知/功能评估。将进行因子分析以检查drf测试的结构，并消除冗余或执行不佳的项目。drf测试的信度和效度将采用经典测试理论进行评估。作为验证研究的一部分，将随机选择一部分研究样本（N=125）接受口腔健康评估，重点是口腔卫生状况、假牙卫生（如果适用）、牙龈炎症和龋齿患病率。口腔健康措施与认知受损患者DRF之间的关系将被检查，以便在未来的研究中为认知受损患者开发基于证据的干预措施提供所需的数据。拟议的研究和培训计划预计将为陈医生提供必要的技能和经验，以发展成为一名以患者为导向的老年牙科研究员。该建议还将产生一种测量DRF的实用方法，从而产生将这些结果纳入临床评估和治疗计划的方法。基于本研究的结果，未来将根据患者的口腔健康需求、DRF和照顾者支持水平，制定基于证据的个性化口腔健康干预方案，并在轻度认知损伤或痴呆患者中进行测试。在此之后，将进行一项随机对照研究，以评估drf测试和基于证据的方案如何为临床医生的决策提供信息，并改善认知障碍患者的临床实践。所有这些都是实现我开发一种新的基于证据的痴呆症牙科护理模式的长期目标所必需的。

DESCRIPTION (provided by applicant): Cognitive impairment is a serious public issue affecting more than one-third of Americans aged 71 and older. Impaired cognitive function compromises dentally-related function (DRF) (e.g, making treatment decisions, performing oral hygiene care, and following homecare instructions), remarkably increasing risk of dental caries, periodontal disease and other oral health issues. Poor oral health is associated with diabetes and increases risk of cardiovascular disease and recurrent respiratory infection, the leading causes of death in special-needs patients. Currently, due to the lack of a reliable and practical methodology, DRF assessment is not a standard part of dental assessment and treatment planning. This fact likely affects quality of care and increases the risk of avoidable complications. In response to this unmet need, Dr. Xi Chen (PI) proposes a career development plan to develop an instrument to assess DRF in cognitively-impaired patients. Dr. Chen is one of the few fellowship-trained geriatric dentists with a substantial grounding in research. He completed his geriatric dentistry fellowship and PhD training in Health Informatics at the University of Minnesota and started his career as an assistant professor at the University of North Carolina at Chapel Hill (UNC-CH) in 2008. His unique background in geriatric dentistry, gerontology and clinical research, together with a strong passion and sense of professional responsibility to advance the field of geriatric dentistry, make him an outstanding candidate for this award. In the past three years, UNC-CH has provided start-up funds, protected time and other excellent support for Dr. Chen, which enabled him to formulate a multidisciplinary mentoring team and complete a number of preliminary studies to conceptualize and test the hypotheses of the proposed studies. A prototype instrument has also been developed and is now ready for further testing. All of these elements have prepared Dr. Chen to become an independent investigator in geriatric dental research. The proposed career development plan includes supervised study and mentored research that will augment Dr. Chen's previous training, complement his proposed research, and develop the expertise needed to foster his transition to being an independent geriatric dental researcher. The proposed training plan consists of didactics (e.g. cognitive neuroscience, cognitive function assessment and measurement design, epidemiology and statistics), clinical and research seminars, and supervised clinical rotation in the UNC neurology clinic. During this award Dr. Chen will meet with his mentors once every other week to discuss the proposed research, training and other career development issues. These training activities aim to help Dr. Chen: A) develop expertise in cognitive and functional assessment for cognitively-impaired patients; B) develop expertise in health measurement scale development and validation; and C) improve clinical research skills. Complementary to the training plan, the mentored research plan aims to enhance Dr. Chen's clinical study skills and provide experience in patient-oriented dental research, all of which is essential to achieving his long- term goal -- development of a new evidence-based dental care model for dementia patients. The proposed research plan is an essential step toward his long-term goal and can be divided into two phases. Phase I is to refine the proposed Dentally-related Function Test (DRF-Test) (Specific Aim 1). A prototype DRF-Test including 17 items has been developed by the PI through literature review and focus group discussions. Two content validity tests, one with practicing geriatric dental experts and one with geriatric experts on cognitive/functional assessment, and a field testing will be conducted. These results will be used to further refine the prototype instrument. The psychometric properties of the DRF-Test will be evaluated during Phase II (Specific Aim 2). The DRF-Test and standard cognitive/functional assessments will be administered to 200 participants with MCI or dementia. Factor analysis will be performed to examine the structure of the DRF-Test and eliminate redundant or poorly-performed items. The reliability and validity of the DRF-Test will be evaluated using the Classical Test Theory. As a part of the validation studies, a subset of the study sample (N=125) will be randomly selected to receive oral health assessment focusing on oral hygiene status, denture hygiene (if applicable), gum inflammation and dental caries prevalence. The association between oral health measures and DRF in cognitively-impaired patients will be examined to provide data required to develop evidence-based interventions for cognitively-impaired patients in a future study. The proposed study and training plans are expected to provide Dr. Chen with the skills and experience essential to developing as a patient oriented researcher in geriatric dentistry. This proposal will also result in a practical method to measure DRF, leading to methods for incorporating these results into clinical assessment and treatment planning. Based on the results of this study, a future evidence-based, individualized oral health intervention protocol corresponding to patients' oral health needs, DRF and level of caregiver support will be developed and tested in patients with MCI or dementia. After that, a randomized control study will be conducted to evaluate how DRF-test and this evidence-based protocol may inform clinician's decision and improve clinical practice for cognitively-impaired patients. All of these are essential to achieving my long-term goal of developing a new evidence-based model of dementia dental care.