Mobile toolbox (MTB) remote measures of executive function and processing speed: development and validation.

OBJECTIVE: The ability to remotely monitor cognitive skills is increasing with the ubiquity of smartphones. The Mobile Toolbox (MTB) is a new measurement system that includes measures assessing Executive Functioning (EF) and Processing Speed (PS): Arrow Matching, Shape-Color Sorting, and Number-Symbol Match. The purpose of this study was to assess their psychometric properties. METHOD: MTB measures were developed for smartphone administration based on constructs measured in the NIH Toolbox® (NIHTB). Psychometric properties of the resulting measures were evaluated in three studies with participants ages 18 to 90. In Study 1 (N = 92), participants completed MTB measures in the lab and were administered both equivalent NIH TB measures and other external measures of similar cognitive constructs. In Study 2 (N = 1,021), participants completed the equivalent NIHTB measures in the lab and then took the MTB measures on their own, remotely. In Study 3 (N = 168), participants completed MTB measures twice remotely, two weeks apart. RESULTS: All three measures exhibited very high internal consistency and strong test-retest reliability, as well as moderately high correlations with comparable NIHTB tests and moderate correlations with external measures of similar constructs. Phone operating system (iOS vs. Android) had a significant impact on performance for Arrow Matching and Shape-Color Sorting, but no impact on either validity or reliability. CONCLUSIONS: Results support the reliability and convergent validity of MTB EF and PS measures for use across the adult lifespan in remote, self-administered designs.

Alignment of Consumers' Expected Brain Benefits from Food and Supplements with Measurable Cognitive Performance Tests.

Consumers often cite cognitive improvements as reasons for making dietary changes or using dietary supplements, a motivation that if leveraged could greatly enhance public health. However, rarely is it considered whether standardized cognitive tests that are used in nutrition research are aligned to outcomes of interest to the consumer. This knowledge gap presents a challenge to the scientific substantiation of nutrition-based cognitive health benefits. Here we combined focus group transcript review using reflexive thematic analysis and a multidisciplinary expert panel exercise to evaluate the applicability of cognitive performance tools/tasks for substantiating the specific cognitive benefits articulated by consumers with the objectives to (1) understand how consumers comprehend the potential benefits of nutrition for brain health, and (2) determine the alignment between consumers desired brain benefits and validated tests and tools. We derived a 'Consumer Taxonomy of Cognitive and Affective Health in Nutrition Research' which describes the cognitive and affective structure from the consumers perspective. Experts agreed that validated tests exist for some consumer benefits including focused attention, sustained attention, episodic memory, energy levels, and anxiety. Prospective memory, flow, and presence represented novel benefits that require the development and validation of new tests and tools. Closing the gap between science and consumers and fostering co-creative approaches to nutrition research are critical to the development of products and dietary recommendations that support realizable cognitive benefits that benefit public health.

Exploring symptom clusters in mild cognitive impairment and dementia with the NIH Toolbox.

OBJECTIVE: Symptom clustering research provides a unique opportunity for understanding complex medical conditions. The objective of this study was to apply a variable-centered analytic approach to understand how symptoms may cluster together, within and across domains of functioning in mild cognitive impairment (MCI) and dementia, to better understand these conditions and potential etiological, prevention, and intervention considerations. METHOD: Cognitive, motor, sensory, emotional, and social measures from the NIH Toolbox were analyzed using exploratory factor analysis (EFA) from a dataset of 165 individuals with a research diagnosis of either amnestic MCI or dementia of the Alzheimer's type. RESULTS: The six-factor EFA solution described here primarily replicated the intended structure of the NIH Toolbox with a few deviations, notably sensory and motor scores loading onto factors with measures of cognition, emotional, and social health. These findings suggest the presence of cross-domain symptom clusters in these populations. In particular, negative affect, stress, loneliness, and pain formed one unique symptom cluster that bridged the NIH Toolbox domains of physical, social, and emotional health. Olfaction and dexterity formed a second unique cluster with measures of executive functioning, working memory, episodic memory, and processing speed. A third novel cluster was detected for mobility, strength, and vision, which was considered to reflect a physical functioning factor. Somewhat unexpectedly, the hearing test included did not load strongly onto any factor. CONCLUSION: This research presents a preliminary effort to detect symptom clusters in amnestic MCI and dementia using an existing dataset of outcome measures from the NIH Toolbox.

Using the Mobile Toolbox in child and adolescent samples: A feasibility study.

Cognitive research with developmental samples requires improved methods that support large-scale, diverse, and open science. This paper offers initial evidence to support the Mobile Toolbox (MTB), a self-administered remote smartphone-based cognitive battery, in youth populations, from a pilot sample of 99 children (Mage = 11.79 years; 36% female; 53% White, 33% Black or African American, 9% Asian, and 15% Hispanic). Completion rates (95%-99%), practice performance (96%-100%), internal consistency (0.60-0.98), and correlations with similar NIHTB measures (0.55-0.77) provide the first evidence to support the MTB in a youth sample, although there were some inconsistencies across measures. Preliminary findings provide promising evidence of the MTB in developmental populations, and further studies are encouraged.

Evaluation of the NIH Toolbox Odor Identification Test across normal cognition, amnestic mild cognitive impairment, and dementia due to Alzheimer's disease.

INTRODUCTION: Olfactory decline is associated with cognitive decline in aging, amnestic mild cognitive impairment (aMCI), and amnestic dementia associated with Alzheimer's disease neuropathology (ADd). The National Institutes of Health Toolbox Odor Identification Test (NIHTB-OIT) may distinguish between these clinical categories. METHODS: We compared NIHTB-OIT scores across normal cognition (NC), aMCI, and ADd participants (N = 389, ≥65 years) and between participants positive versus negative for AD biomarkers and the APOE ε4 allele. RESULTS: NIHTB-OIT scores decreased with age (p < 0.001) and were lower for aMCI (p < 0.001) and ADd (p < 0.001) compared to NC participants, correcting for age and sex. The NIHTB-OIT detects aMCI (ADd) versus NC participants with 49.4% (56.5%) sensitivity and 88.8% (89.5%) specificity. NIHTB-OIT scores were lower for participants with positive AD biomarkers (p < 0.005), but did not differ based on the APOE ε4 allele (p > 0.05). DISCUSSION: The NIHTB-OIT distinguishes clinically aMCI and ADd participants from NC participants. HIGHLIGHTS: National Institutes of Health Toolbox Odor Identification Test (NIHTB-OIT) discriminated normal controls from mild cognitive impairment. NIHTB-OIT discriminated normal controls from Alzheimer's disease dementia. Rate of olfactory decline with age was similar across all diagnostic categories. NIHTB-OIT scores were lower in participants with positive Alzheimer's biomarker tests. NIHTB-OIT scores did not differ based on APOE genotype.

Automated procedure for demographic adjustments on cognitive test scores.

Performances of normal people on cognitive tests are known to vary by demographic characteristics, such as age, education, and sex. Thus, cognitive test scores should be corrected for demographic influences when they are used to detect below-expected results due to disease or injury involving the central nervous system (CNS). Normative corrections, if estimated from a large, diverse, and well-characterized cohort of controls, help to remove expected differences in cognitive performance associated with normal demographic characteristics and associated socio-economic disadvantages. In this paper, we (1) describe in detail the process of generating regression-based normative standards, and its advantages and limitations, (2) provide recommendations for applying these normative standards to data from individuals and populations at risk for CNS dysfunction, and (3) introduce an R package, test2norm, that contains functions for producing and applying normative formulas to generate demographically corrected scores for measuring deviations from expected, normal cognitive performances.

Modeling the normal:abnormal spectrum of early childhood internalizing behaviors: A clinical-developmental approach for the Multidimensional Assessment Profiles Internalizing Dimensions.

BACKGROUND: We expanded the Multidimensional Assessment Profiles (MAPS) Scales developmental specification model to characterize the normal:abnormal spectrum of internalizing (anxious and depressive) behaviors in early childhood via the MAPS-Internalizing (MAPS-INT) scale. METHODS: The MAPS-INT item pool was generated based on clinical expertise and prior research. Analyses were conducted on a sub-sample of families (n = 183) from the diverse When to Worry early childhood sample. RESULTS: Normal:abnormal descriptive patterns for both anxious and depressive behaviors were consistent with prior work: (1) extremes of normative variation are abnormal when very frequent; and (2) pathognomonic indicators that most children do not engage in and are abnormal, even if infrequent. Factor analysis revealed a two-factor MAPS-INT Anxious Behaviors structure (Fearful-Worried and Separation Distress) and a unidimensional MAPS-INT Depressive Behaviors factor with good fit and good-to-excellent test-retest reliability and validity. CONCLUSIONS: We characterized the normal:abnormal spectrum of internalizing behaviors in early childhood via the MAPS-INT. Future research in larger representative samples can replicate and extend findings, including clinical thresholds and predictive utility. The MAPS-INT helps lay the groundwork for dimensional characterization of the internalizing spectrum to advance neurodevelopmental approaches to emergent psychopathology and its earlier identification.

Pilot Testing of the MyCog Assessment: Rapid Detection of Cognitive Impairment in Everyday Clinical Settings.

Cognitive impairment (CI) and dementia can have profound social and emotional effects on older adults. Early detection of CI is imperative both to the identification of potentially treatable conditions and to provide services to minimize the effects of CI in cases of dementia. While primary care settings are ideal for identifying CI, it frequently goes undetected. We tailored a brief, iPad-based, cognitive assessment (MyCog) for primary care settings and piloted it in a sample of older adults. Eighty participants were recruited from an existing cohort study and completed a brief, in-person interview. CI was determined based on a diagnosis of dementia or CI in their medical record or based on a comprehensive cognitive battery performed within the past 18 months. MyCog had a sensitivity of 79% and specificity of 82%, offering a practical, scalable, primary care assessment for the routine case finding of cognitive impairment and dementia.

Remote Cognitive Screening Of Healthy Older Adults for Primary Care With the MyCog Mobile App: Iterative Design and Usability Evaluation.

BACKGROUND: Annual cognitive screening in adults aged >65 years can improve early detection of cognitive impairment, yet less than half of all cases are identified in primary care. Time constraints in primary care settings present a major barrier to routine screening. A remote cognitive screener completed on a patient's own smartphone before a visit has the potential to save primary care clinics time, encourage broader screening practices, and increase early detection of cognitive decline. OBJECTIVE: We described the iterative design and proposed the implementation of a remote cognitive screening app, MyCog Mobile, to be completed on a patient's smartphone before an annual wellness visit. The research questions were as follows: What would motivate primary care clinicians and clinic administrators to implement a remote cognitive screening process? How might we design a remote cognitive screener to fit well with existing primary care workflows? What would motivate an older adult patient to complete a cognitive screener on a smartphone before a primary care visit? How might we optimize the user experience of completing a remote cognitive screener on a smartphone for older adults? METHODS: To address research questions 1 and 2, we conducted individual interviews with clinicians (n=5) and clinic administrators (n=3). We also collaborated with clinic administrators to create user journey maps of their existing and proposed MyCog Mobile workflows. To address research questions 3 and 4, we conducted individual semistructured interviews with cognitively healthy older adults (n=5) and solicited feedback from a community stakeholder panel (n=11). We also tested and refined high-fidelity prototypes of the MyCog Mobile app with the older adult interview participants, who rated the usability on the Simplified System Usability Scale and After-Scenario Questionnaire. RESULTS: Clinicians and clinic administrators were motivated to adopt a remote cognitive screening process if it saved time in their workflows. Findings from interviews and user journey mapping informed the proposed implementation and core functionality of MyCog Mobile. Older adult participants were motivated to complete cognitive screeners to ensure that they were cognitively healthy and saw additional benefits to remote screening, such as saving time during their visit and privacy. Older adults also identified potential challenges to remote smartphone screening, which informed the user experience design of the MyCog Mobile app. The average rating across prototype versions was 91 (SD 5.18) on the Simplified System Usability Scale and 6.13 (SD 8.40) on the After-Scenario Questionnaire, indicating above-average usability. CONCLUSIONS: Through an iterative, human-centered design process, we developed a viable remote cognitive screening app and proposed an implementation strategy for primary care settings that was optimized for multiple stakeholders. The next steps include validating the cognitive screener in clinical and healthy populations and piloting the finalized app in a community primary care clinic.

Sensitivity of the NIH Toolbox to Detect Cognitive Change in Individuals With Intellectual and Developmental Disability.

BACKGROUND AND OBJECTIVE: Individuals with intellectual disability (ID) experience protracted cognitive development compared with typical youth. Sensitive measurement of cognitive change in this population is a critical need for clinical trials and other intervention studies, but well-validated outcome measures are scarce. This study's aim was to evaluate the sensitivity of the NIH Toolbox Cognition Battery (NIHTB-CB) to detect developmental changes in groups with ID-fragile X syndrome (FXS), Down syndrome (DS), and other ID (OID)-and to provide further support for its use as an outcome measure for treatment trials. METHODS: We administered the NIHTB-CB and a reference standard cross-validation measure (Stanford-Binet Intelligence Scales, Fifth Edition [SB5]) to 256 individuals with FXS, DS, and OID (ages 6-27 years). After 2 years of development, we retested 197 individuals. Group developmental changes in each cognitive domain of the NIHTB-CB and SB5 were assessed using latent change score models, and 2-year growth was evaluated at 3 age points (10, 16, and 22 years). RESULTS: Overall, effect sizes of growth measured by the NIHTB-CB tests were comparable with or exceeded those of the SB5. The NIHTB-CB showed significant gains in almost all domains in OID at younger ages (10 years), with continued gains at 16 years and stability in early adulthood (22 years). The FXS group showed delayed gains in attention and inhibitory control compared with OID. The DS group had delayed gains in receptive vocabulary compared with OID. Unlike the other groups, DS had significant growth in early adulthood in 2 domains (working memory and attention/inhibitory control). Notably, each group's pattern of NIHTB-CB growth across development corresponded to their respective pattern of SB5 growth. DISCUSSION: The NIHTB-CB is sensitive to developmental changes in individuals with ID. Comparison with levels and timing of growth on the cross-validation measure shows that the NIHTB-CB has potential to identify meaningful trajectories across cognitive domains and ID etiologies. Sensitivity to change within the context of treatment studies and delineation of clinically meaningful changes in NIHTB-CB scores, linked to daily functioning, must be established in future research to evaluate the battery more completely as a key outcome measure.

Uses of the NIH Toolbox® in Clinical Samples: A Scoping Review.

Background and Objectives: The NIH Toolbox® for the Assessment of Neurologic and Behavioral Function is a compilation of computerized measures designed to assess sensory, motor, emotional, and cognitive functioning of individuals across the life span. The NIH Toolbox was initially developed for use with the general population and was not originally validated in clinical populations. The objective of this scoping review was to assess the extent to which the NIH Toolbox has been used with clinical populations. Methods: Guided by the Joanna Briggs Methods Manual for Scoping Reviews, records were identified through searches of PubMed MEDLINE, PsycINFO, ClinicalTrials.gov, EMBASE, and ProQuest Dissertations and Theses Global (2008-2020). Database searches yielded 5,693 unique titles of original research that used at least one NIH Toolbox assessment in a sample characterized by any clinical diagnosis. Two reviewers screened titles, abstracts, and full texts for inclusion in duplicate. Conflicts at each stage of the review process were resolved by a group discussion. Results: Ultimately, 281 publication records were included in this scoping review (nJournal Articles = 104, nConference Abstracts = 84, nClinical Trial Registrations = 86, and nTheses/Dissertations = 7). The NIH Toolbox Cognition Battery was by far the most used of the 4 batteries in the measurement system (nCognition = 225, nEmotion = 49, nMotor = 29, and nSensation = 16). The most represented clinical category was neurologic disorders (n = 111), followed by psychological disorders (n = 39) and cancer (n = 31). Most (96.8%) of the journal articles and conference abstracts reporting the use of NIH Toolbox measures with clinical samples were published in 2015 or later. As of May 2021, these records had been cited a total of nearly 1,000 times. Discussion: The NIH Toolbox measures have been widely used among individuals with various clinical conditions across the life span. Our results lay the groundwork to support the feasibility and utility of administering the NIH Toolbox measures in research conducted with clinical populations and further suggest that these measures may be of value for implementation in fast-paced clinical settings as part of routine practice.

Challenges in Participant Engagement and Retention Using Mobile Health Apps: Literature Review.

BACKGROUND: Mobile health (mHealth) apps are revolutionizing the way clinicians and researchers monitor and manage the health of their participants. However, many studies using mHealth apps are hampered by substantial participant dropout or attrition, which may impact the representativeness of the sample and the effectiveness of the study. Therefore, it is imperative for researchers to understand what makes participants stay with mHealth apps or studies using mHealth apps. OBJECTIVE: This study aimed to review the current peer-reviewed research literature to identify the notable factors and strategies used in adult participant engagement and retention. METHODS: We conducted a systematic search of PubMed, MEDLINE, and PsycINFO databases for mHealth studies that evaluated and assessed issues or strategies to improve the engagement and retention of adults from 2015 to 2020. We followed the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. Notable themes were identified and narratively compared among different studies. A binomial regression model was generated to examine the factors affecting retention. RESULTS: Of the 389 identified studies, 62 (15.9%) were included in this review. Overall, most studies were partially successful in maintaining participant engagement. Factors related to particular elements of the app (eg, feedback, appropriate reminders, and in-app support from peers or coaches) and research strategies (eg, compensation and niche samples) that promote retention were identified. Factors that obstructed retention were also identified (eg, lack of support features, technical difficulties, and usefulness of the app). The regression model results showed that a participant is more likely to drop out than to be retained. CONCLUSIONS: Retaining participants is an omnipresent challenge in mHealth studies. The insights from this review can help inform future studies about the factors and strategies to improve participant retention.

New complementary perspectives for inpatient physical function assessment: matched clinician-report and patient-report short form measures from the PROMIS adult physical function item bank.

PURPOSE: To develop two item content-matched, precise, score-level targeted inpatient physical function (PF) short form (SF) measures: one clinician-reported, one patient-reported. Items were derived from PROMIS PF bank content; scores are reported on the PROMIS PF T-score metric. METHODS: The PROMIS PF item bank was reviewed for content measuring lower-level PF status (T-scores 10-50) with high item set score-level reliability (≥ 0.90). Selected patient-reported (PR) items were also edited to function as clinician-reported (CR) items. Items were reviewed by clinicians and field tested; responses were assessed for meeting PROMIS measure development standards. New CR and PR items were calibrated using patient responses to the original PROMIS PF items as anchoring data. SFs were constructed, based on content and precision. RESULTS: Nine PROMIS PF items were candidates for CR and PR inpatient PF assessment; three new items were written to extend content coverage. An inpatient sample (N = 515; 55.1% female; mean age = 66.2 years) completed 12 PR items and was assessed by physical therapists (using 12 CR items). Analyses indicated item sets met expected measure development standards. Twelve new CR and three new PR items were linked to the PROMIS PF metric (raw score r = 0.73 and 0.90, respectively). A 5-item CR SF measure was constructed; score-level reliabilities were ≥ 0.90 for T-scores 13-45. A 5-item PR SF measure was assembled, mirroring CR SF content. CONCLUSIONS: Two item content-matched SFs have been developed for clinician and patient reporting and are an effective, efficient means of assessing inpatient PF and offer complementary perspectives.

Recommendations for Assessment of Social, Emotional, and Behavioral Health for the National Children's Study.

The Social Emotional Behavioral (SEB) Team of the National Children's Study (NCS) was tasked with making recommendations for assessment of important aspects of social-emotional health and function in children. This paper describes the constructs recommended for assessment along with the rationale for their assessment. These constructs, representing aspects of Social Relationships, Social Capital, Temperament, Negative Affect, Externalizing Behavior, Social Competence, Self-efficacy, Self-image, Psychological well-being, Ethnic/racial Socialization, Perceived Discrimination, Sexual Orientation, Religiosity, and Perceived Stress and Resilience were identified as being critical to the understanding of children's health and development from birth to age 21.

Reliability and Validity of the Spanish-Language Version of the NIH Toolbox.

The psychometric properties of the English-language NIH Toolbox for Assessment of Neurological and Behavioral Function (NIH Toolbox) have been examined in numerous populations. This study evaluated the reliability and validity of the Spanish-language NIH Toolbox. Participants were children aged 3 to 7 years and adults aged 18 to 85 years who took part in the NIH Toolbox norming study in Spanish. Results supported the internal consistency reliability of included measures. Test-retest reliability was strong for most tests, though it was weaker for the test of olfaction among children and the test of locomotion among adults. Spearman's correlations and general linear models showed Spanish tests were often associated with age, sex, and education. Convergent validity for the two language measures that underwent more intensive development, evaluated via Spearman's correlations with legacy measures, was strong. Results support using the Spanish-language NIH Toolbox to measure neurological and behavioral functioning among Spanish-speaking individuals in the United States.

Associations between NIH Toolbox Cognition Battery and in vivo brain amyloid and tau pathology in non-demented older adults.

INTRODUCTION: The National Institutes of Health (NIH) Toolbox Cognition Battery (NIHTB-CB) was developed to be a common assessment metric across a broad array of research studies. We investigated associations between NIHTB-CB and brain amyloid and tau deposition in cognitively unimpaired older adults. METHODS: One hundred eighteen community-based volunteers completed magnetic resonance imaging (MRI), Pittsburgh compound B (PiB)-PET (positron emission tomography) and AV-1451-PET neuroimaging, a neuropsychological evaluation, NIHTB-CB, and the Clinical Dementia Rating (CDR) scale. Demographically adjusted regression models evaluated cognition-biomarker associations; standardized effect sizes allowed comparison of association strength across measures. RESULTS: No NIHTB-CB measures were associated with amyloid deposition. NIHTB-CB measures of fluid cognition, including Pattern Comparison Processing Speed, Dimensional Change Card Sort, and Fluid Cognition Composite, were associated with tau deposition in higher Braak regions. Pattern Comparison Processing Speed was the most robust association with sensitivity analyses. DISCUSSION: NIHTB-CB tasks of processing speed and executive functions may be sensitive to pathologic tau deposition on imaging in normal aging.

The NIH Toolbox: Overview of Development for Use with Hispanic Populations.

OBJECTIVE: Hispanics/Latinos are the largest and fastest-growing minority population in the United States. To facilitate appropriate outcome assessment of this expanding population, the NIH Toolbox for Assessment of Neurological and Behavioral Function® (NIH Toolbox®) was developed with particular attention paid to the cultural and linguistic needs of English- and Spanish-speaking Hispanics/Latinos. METHODS: A Cultural Working Group ensured that all included measures were appropriate for use with Hispanics/Latinos in both English and Spanish. In addition, a Spanish Language Working Group assessed all English-language NIH Toolbox measures for translatability. RESULTS: Measures were translated following the Functional Assessment of Chronic Illness Therapy (FACIT) translation methodology for instances where language interpretation could impact scores, or a modified version thereof for more simplified translations. The Spanish versions of the NIH Toolbox Cognition Battery language measures (i.e., Picture Vocabulary Test, Oral Reading Recognition Test) were developed independently of their English counterparts. CONCLUSIONS: The Spanish-language version of the NIH Toolbox provides a much-needed set of tools that can be selected as appropriate to complement existing protocols being conducted with the growing Hispanic/Latino population in the United States.

Validation of the NIH Toolbox Cognitive Battery in intellectual disability.

OBJECTIVE: To advance the science of cognitive outcome measurement for individuals with intellectual disability (ID), we established administration guidelines and evaluated the psychometric properties of the NIH-Toolbox Cognitive Battery (NIHTB-CB) for use in clinical research. METHODS: We assessed feasibility, test-retest reliability, and convergent validity of the NIHTB-CB (measuring executive function, processing speed, memory, and language) by assessing 242 individuals with fragile X syndrome (FXS), Down syndrome (DS), and other ID, ages 6 through 25 years, with retesting completed after 1 month. To facilitate accessibility and measurement accuracy, we developed accommodations and standard assessment guidelines, documented in an e-manual. Finally, we assessed the sensitivity of the battery to expected syndrome-specific cognitive phenotypes. RESULTS: Above a mental age of 5.0 years, all tests had excellent feasibility. More varied feasibility across tests was seen between mental ages of 3 and 4 years. Reliability and convergent validity ranged from moderate to strong. Each test and the Crystallized and Fluid Composite scores correlated moderately to strongly with IQ, and the Crystallized Composite had modest correlations with adaptive behavior. The NIHTB-CB showed known-groups validity by detecting expected executive function deficits in FXS and a receptive language deficit in DS. CONCLUSION: The NIHTB-CB is a reliable and valid test battery for children and young adults with ID with a mental age of ≈5 years and above. Adaptations for very low-functioning or younger children with ID are needed for some subtests to expand the developmental range of the battery. Studies examining sensitivity to developmental and treatment changes are now warranted.

The expansion and validation of a new upper extremity item bank for the Patient-Reported Outcomes Measurement Information System® (PROMIS).

BACKGROUND: The Patient-Reported Outcomes Measurement Information System® (PROMIS) includes a Physical Function (PF) item bank and an Upper Extremity (UE) item bank, which is composed of a subset of items from the PF bank. The UE item bank has few items and known ceiling effects. Therefore, this study aimed to expand the item bank to assess a wider range of functioning. With the additional content, other psychometric properties-improved content validity, item bank depth, range of measurement, and score reliability-were also evaluated. We convened an expert panel to review potential items, and then conducted psychometric analyses on both extant and newly-collected data. RESULTS: Expert focus groups reviewed the PF item bank for items that were "sufficiently" related to upper extremity functioning for inclusion in the expanded UE item bank. The candidate item bank was quantitatively evaluated in a new sample of 600 people. The final items were calibrated in an aggregated dataset (n = 11,635) from two existing datasets, and the newly collected sample. The original UE item bank included 15 items. After expert review and quantitative evaluation, 31 items were added. The combined 46 items were calibrated using item response theory (IRT). Then computer adaptive tests (CATs) were simulated based off of the psychometric results. These indicated that the new UE item bank has an extended measurement range compared to the original version. CONCLUSIONS: The expanded PROMIS UE item bank assesses a wider range of upper extremity functioning compared to the initial UE item bank. However, ceiling effects remain a concern for unimpaired groups. The new UE item bank is recommended for individuals with known or suspected upper extremity limitations.