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

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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.