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

摘要 美国国立卫生研究院(NIH)患者报告结果测量信息系统 (PROMIS®)措施被开发，以提供患者报告的高度精确和有效的测量 结果，建立一个跨慢性健康状况的通用指标，并实现计算机化的自适应 测试。PROMIS措施还没有在老年人中得到广泛测试，特别是那些 80岁及以上，也不在轻度认知障碍(MCI)和阿尔茨海默病及相关人群中 痴呆(ADRD)。MCI和ADRD问卷调查结果的信度和效度 PROMIS测量是未知的，认知筛查测试的门槛也是未知的，在认知筛查测试中，自我报告结果 数据不再代表潜在的健康状况。总体研究的具体目标是验证 Promis个人资料测量老年人，并确定认知障碍的阈值 使这些措施无效。我们将测试PROMIS个人资料测量(29项、43项和57项)的效用 版本)在有不同程度认知障碍的老年人中寻找阈值(分界点) 患者报告的数据不再能够可靠或有效地获得。认知水平将用 蒙特利尔认知评估(MoCA)和简易精神状态检查(MMSE)。总共438个 受试者将从门诊登记，确保受试者的数量相等，年龄在65-79岁和80岁以上 以及从正常认知到MCI再到ADRD的一系列认知功能。质的认知 对38名老年人的访谈检查了患者对个别项目的理解和提供有效信息的能力 信息。认知阈值的定量调查将使用PROMIS档案进行评估 在另外400名老年人样本中进行测量，以确定认知阈值， 变得不一致、不可靠和无效。第一个行政副刊扩大了简短的认识 评估(MMSE，MoCA)，包括a)更敏感的NIH工具箱认知电池，b)读数 理解量表；c)促进应用认知能力和关注度的测评 元认知(认知缺陷意识)。这第二份行政副刊将提供 额外的资源，以收集更多关于80岁以上的人和有更大认知障碍的人的数据。 在新冠肺炎大流行期间，由于更大的困难，这些团体的注册非常困难 停摆期间的远程医疗，以及当面访问时前往办公室的更大障碍 已重新启动。它还将使我们的招聘扩大到更多的诊所，以招聘更多的非洲人 美国人，以及那些与更多样化的医疗条件有关的认知障碍的人。这项研究将 产生实用数据，以便立即转化为临床实践，并用于进一步研究 具有不同程度认知障碍的老年人，以提供对残疾测量的准确反应 和心理上的痛苦。

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.