PROMIS Profile Measures in Older Adults - Identifying Cognitive Thresholds for Reliable and Valid Responses

总结 美国国立卫生研究院（NIH）患者报告结局测量信息系统 （PROMIS®）的措施，以提供高度精确和有效的措施，病人报告 结果，建立慢性健康状况的共同指标，并使计算机化的自适应 试验. PROMIS措施尚未在老年人中进行广泛测试，特别是那些 80岁及以上的老年人，也没有轻度认知障碍（MCI），阿尔茨海默氏症和相关 痴呆症（ADRD）。MCI和ADRD患者提供的关于 PROMIS指标未知，认知筛查测试的阈值也未知， 数据不再代表基本的健康状况。整个研究的具体目的是验证 PROMIS概况测量老年人，并确定认知障碍的阈值， 使这些措施无效。我们将测试PROMIS Profile测量（29项、43项和57项）的实用性 版本）中的老年人不同程度的认知障碍，以找到阈值（临界点）， 患者报告的数据不再能够可靠或有效地获得。认知水平将通过 蒙特利尔认知评估（莫卡）和简易精神状态检查（MMSE）。共有438 受试者将从门诊诊所入组，确保受试者数量相同，年龄为65-79岁和80岁以上 年，以及从正常认知到MCI到ADRD的认知功能谱。质的认知 对38名老年人的访谈检查了患者对单个项目的理解和提供有效信息的能力， 信息.将使用PROMIS特征评估认知阈值的定量研究 在400名老年人的额外样本中进行测量，以确定响应的认知阈值。 变得不一致、不可靠和无效。第一次行政补充扩大了对行政法的简要认识， 评估（MMSE，莫卡），a）更敏感的NIH认知测验，B）a阅读 理解措施，和c）PROMIS应用认知能力和关注措施，以评估 元认知（认知缺陷的意识）。第二次行政补充将提供 增加资源，收集更多关于80岁以上和认知障碍严重者的数据。 在2019冠状病毒病大流行期间，这些群体的入学非常具有挑战性，原因是 关闭期间的远程医疗，以及亲自访问时前往办公室的更大障碍 重启这也将使我们的招聘扩大到更多的诊所设置，以招募更多的非洲人， 美国人，以及那些与更多样化的医疗条件相关的认知障碍患者。本研究将 产生实用的数据，立即转化为临床实践，并进一步研究的能力， 具有不同程度认知障碍的老年人，以提供有关残疾程度的准确回答 和心理困扰

Summary The National Institutes of Health (NIH) Patient-Reported Outcomes Measurement Information System (PROMIS®) measures were developed to provide highly precise and valid measures of patient-reported outcomes, establish a common metric across chronic health conditions, and enable computerized adaptive testing. The PROMIS measures have not been widely tested in the older adult population, especially those aged 80 and older nor among those with Mild Cognitive Impairment (MCI), and Alzheimer’s and Related Dementias (ADRD). The reliability and validity of responses provided by those with MCI and ADRD on PROMIS measures is unknown, as is the threshold on cognitive screening tests where self-reported outcomes data is no longer representative of underlying health status. The Specific Aim of the overall study is to validate the PROMIS Profile measures in older adults and to identify the threshold where cognitive impairment invalidates these measures. We will test the utility of the PROMIS Profile measures (29-, 43-, and 57-item versions) among older adults with varying levels of cognitive impairment to find thresholds (cut-points) where patient-reported data can no longer be reliably or validly attained. Cognitive levels will be assessed with the Montreal Cognitive Assessment (MoCA) and the Mini-Mental State Examination (MMSE). A total of 438 subjects will be enrolled from outpatient practices ensuring equal numbers of subjects, ages 65-79 and 80+ years, as well as a spectrum of cognitive function from normal cognition to MCI to ADRD. Qualitative cognitive interviews in 38 older adults examined patient understanding of individual items and capacity to provide valid information. Quantitative investigation of thresholds of cognition will be assessed using the PROMIS profile measures in an additional sample of 400 older adults to identify the cognitive threshold where responses become inconsistent, unreliable, and invalid. The first administrative supplement expanded the brief cognitive assessments (MMSE, MoCA) with a) the more sensitive NIH Toolbox Cognition Battery, b) a reading comprehension measure, and c) the PROMIS Applied Cognition Abilities and Concerns measure to assess metacognition (awareness of cognitive deficits). This second administrative supplement will provide additional resources to collect more data on people over age 80 and those with greater cognitive impairment. These groups were very challenging to enroll during the COVID-19 pandemic due to greater difficulty with telemedicine during the shutdown, and greater barriers in travelling to the office when in-person visits restarted. It will also enable expansion of our recruitment to additional clinic settings to recruit more African Americans, and those with cognitive impairment related to more diverse medical conditions. This study will result in practical data for immediate translation to clinical practice and for further research on the capacity of older adults with varying levels of cognitive impairment to provide accurate responses on measures of disability and psychological distress.