Development of the PROMIS pediatric stigma and extension to the PROMIS pediatric stigma: skin item banks.

PURPOSE: To develop the PROMIS Pediatric Stigma (PPS) and Skin (PPS-Skin) by constructing a common metric for measuring stigma in children with various conditions, while capturing the unique features of each condition. METHODS: Data from 860 children, ages 8-17, with a diagnosis of epilepsy, pNF (neurofibromatosis type 1 associated neurofibroma plexform), MD (muscular dystrophy), cancer, or skin conditions recruited from three projects were analyzed. Children with epilepsy, pNF and MD (sample-1) completed the original 18-item Neuro-QoL Stigma, while children with cancer and skin conditions (e.g., atopic dermatitis, psoriasis, and genetic skin disorders; sample-2) completed a 16-item version and 6 additional skin related items. Exploratory factor analysis (EFA) and confirmatory analysis (CFA) were used to evaluate unidimensionality of 24 stigma items. Differential item functioning (DIF) was used to evaluate measurement equivalence on group, gender, age, and conditions. Item response theory model (IRT) was used to construct the final measure. RESULTS: Sufficient unidimensionality was supported by both EFA and CFA. No items showed significant DIF indicating stable measurement properties across groups of comparison. All items fit the IRT model and were able to be calibrated together to form the PPS which consists of 18 core items. The PPS-Skin (18 cores items + 6 skin items) was developed by calibrating 6 skin items onto the common metric as the PPS. CONCLUSIONS: We used IRT techniques to successfully develop the PPS and the PPS-Skin, which share a common metric and account for unique and common concerns related to chronic conditions.

Baseline characterization of the ARMADA (Assessing Reliable Measurement in Alzheimer's Disease) study cohorts.

INTRODUCTION: The National Institutes of Health (NIH) Toolbox (NIHTB) provides computerized measures of cognition, emotion, sensation, and motor abilities across the lifespan. The ARMADA (Assessing Reliable Measurement in Alzheimer's Disease and Cognitive Aging) study validated the NIHTB in individuals across the cognitive aging spectrum. This article reports the characteristics of our sample of participants. METHODS: Participants were recruited across nine sites and classified clinically as cognitively normal (NC), with mild cognitive impairment (MCI), or with dementia of the Alzheimer's type (DAT.) They completed the NIHTB at multiple time points and many had at least one Alzheimer's biomarker previously obtained. RESULTS: Groups differed with respect to dementia severity levels, as anticipated, but were well-matched across many demographic characteristics. DISCUSSION: The ARMADA study demographics and baseline characteristics provide a suitable sample for validating the NIHTB across the cognitive aging spectrum. Other enriched samples (African American participants, Spanish NIHTB, 85+ years of age) will be reported elsewhere. HIGHLIGHTS: There is a need for assessments that can detect the early stages of cognitive decline in older adults. The ARMADA (Assessing Reliable Measurement in Alzheimer's Disease and Cognitive Aging) study will validate the National Institutes of Health (NIH) Toolbox across the aging spectrum, including mild cognitive impairment (MCI) and dementia of the Alzheimer's type (DAT). Here we report the characteristics of participants. Groups were well-matched across most demographic characteristics, and clinical characteristics differed as expected. ARMADA study cohorts reflect their respective clinical syndromes for validating the NIH Toolbox.

The use of proxies and proxy-reported measures: a report of the international society for quality of life research (ISOQOL) proxy task force.

AIMS: Proxy reports are often used when patients are unable to self-report. It is unclear how proxy measures are currently in use in adult health care and research settings. We aimed to describe how proxy reports are used in these settings, including the use of measures developed specifically for proxy reporting in adult health populations. METHODS: We systematically searched Medline, PsycINFO, PsycTESTS, CINAHL and EMBASE from database inception to February 2018. Search terms included a combination of terms for quality of life and health outcomes, proxy-reporters, and health condition terms. The data extracted included clinical context, the name of the proxy measure(s) used and other descriptive data. We determined whether the measures were developed specifically for proxy use or were existing measures adapted for proxy use. RESULTS: The database search identified 17,677 possible articles, from which 14,098 abstracts were reviewed. Of these, 11,763 were excluded and 2335 articles were reviewed in full, with 880 included for data extraction. The most common clinical settings were dementia (30%), geriatrics (15%) and cancer (13%). A majority of articles (51%) were paired studies with proxy and patient responses for the same person on the same measure. Most paired studies (77%) were concordance studies comparing patient and proxy responses on these measures. DISCUSSION: Most published research using proxies has focused on proxy-patient concordance. Relatively few measures used in research with proxies were specifically developed for proxy use. Future work is needed to examine the performance of measures specifically developed for proxies. SYSTEMATIC REVIEW REGISTRATION: PROSPERO No. CRD42018103179.

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.

ARMADA: Assessing reliable measurement in Alzheimer's disease and cognitive aging project methods.

INTRODUCTION: Early detection of cognitive decline in older adults is a public health priority. Advancing Reliable Measurement in Alzheimer's Disease and Cognitive Aging (ARMADA), a multisite study, is validating cognition, emotion, motor, and sensory modules of the National Institutes of Health Toolbox for Assessment of Neurological and Behavioral Function (NIHTB) in the aging spectrum from cognitively normal to dementia of the Alzheimer's type (DAT). METHODS: Participants 65 to 85 years old, in demographic groups racially proportional to the general US population, are recruited in one of three groups to validate the NIHTB: cognitively normal, amnestic mild cognitive impairment (aMCI), or mild DAT. Additional special emphasis cohorts include (1) Blacks in the three clinical groups; (2) Spanish-speakers in the three clinical groups; (3) cognitively normal, population-proportional, over age 85. DISCUSSION: Longitudinal study will determine whether NIHTB can predict cognitive decline and is associated with Alzheimer's disease biomarkers. Here, we detail the methods for the ARMADA study.

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.

PROMIS® Pediatric Depressive Symptoms as a Harmonized Score Metric.

OBJECTIVE: To conduct an evidence-based review of adolescent self-report depression measures and to demonstrate how various measures can be rescored onto a harmonized metric. METHOD: Six widely used person-reported outcome measures (PROMs) were reviewed. Psychometric properties were evaluated using previously published guidance for PROMs. Next, two secondary data sources (from an outpatient behavioral health clinic and from the general population) were evaluated to harmonize scores across three of the measures. Both item response theory and equipercentile linking methods were used and compared. RESULTS: All six PROMs demonstrated a high evidence base for widespread use depending on the purpose of the assessments. Adolescent involvement when developing the PROM for content validity and floor or ceiling effects were the least frequent available evidence. Three of the PROMs were linked to the PROMIS® Pediatric Depressive Symptoms v2.0 (PROMIS-PedDepSx) metric. The scales were highly correlated and essentially unidimensional when aggregated. All linking methods were broadly comparable. Group-level score conversions are recommended to minimize linking bias. CONCLUSIONS: There are a number of strong, widely used PROMs for the evidence-based assessment (EBD) of adolescent depression. However, score comparability is a concern whenever there is a proliferation of measures. Harmonized score metrics support data aggregation and re-analysis. Using four PROMs, one of which served as the scoring metric, we demonstrated the possibility of harmonized depression scores. Future directions for EBD should evaluate whether harmonized PROMs for other pediatric health domains would be useful.

Parent-reported cognitive function is associated with leukoencephalopathy in children with brain tumors.

PURPOSE: Cognitive dysfunction is a major concern for children with brain tumors. A valid, user-friendly screening tool could facilitate prompt referral for comprehensive neuropsychological assessments and therefore early intervention. Applications of the pediatric perceived cognitive function item bank (pedsPCF) such as computerized adaptive testing can potentially serve as such a tool given its brevity and user-friendly nature. This study aimed to evaluate whether pedsPCF was a valid indicator of cerebral compromise using the criterion of structural brain changes indicated by leukoencephalopathy grades. METHODS: Data from 99 children (mean age = 12.6 years) with brain tumors and their parents were analyzed. Average time since diagnosis was 5.8 years; time since last treatment was 4.3 years. Leukoencephalopathy grade (range 0-4) was based on white matter damage and degree of deep white matter volume loss shown on MRI. Parents of patients completed the pedsPCF. Scores were based on the US general population-based T-score metric (mean = 50; SD = 10). Higher scores reflect better function. RESULTS: Leukoencephalopathy grade distributions were as follows: 36 grade 0, 27 grade 1, 22 grade 2, 13 grade 3, and 1 grade 4. The mean pedsPCF T-score was 48.3 (SD = 8.3; range 30.5-63.7). The pedsPCF scores significantly discriminated patients with different leukoencephalopathy grades, F = 4.14, p = 0.0084. Effect sizes ranged from 0.09 (grade 0 vs. 1) to 1.22 (grade 0 vs. 3/4). CONCLUSION: This study demonstrates that the pedsPCF is a valid indicator of leukoencephalopathy and provides support for its use as a screening tool for more comprehensive neurocognitive testing.

Neuro-QoL health-related quality of life measurement system: Validation in Parkinson's disease.

INTRODUCTION: Neuro-QoL is a multidimensional patient-reported outcome measurement system assessing aspects of physical, mental, and social health identified by neurology patients and caregivers as important. One of the first neurology-specific patient-reported outcome measure systems created using modern test development methods, Neuro-Qol enables brief, yet precise, assessment and the ability to conduct both PD-specific and cross-disease comparisons. We present results of Neuro-QoL clinical validation using a sample of PD patients. METHODS: A total of 120 PD patients recruited from academic medical centers were assessed at baseline, 1 week, and 6 months. Assessments included Neuro-QoL and general and PD-specific validity measures. RESULTS: Participants were 62% male and 95% white (average age = 66); H & Y stages were 1 (16%), 2 (61%), 3 (18%), and 4 (5%). Internal consistency and test-retest reliability of Neuro-QoL ranged from Cronbach's alphas = 0.81 to 0.94 with intraclass correlation coefficients = 0.66 to 0.80. Pearson's correlations between Neuro-QoL and legacy measures were generally moderate and in expected directions. UPDRS Part 2 was moderately correlated with Neuro-QoL Upper Extremity and Mobility, respectively (r's = -0.44; -0.59). Parkinson's Disease Questionnaire-39 and Neuro-QoL measures of similar constructs showed strong-to-moderate correlations (r's = 0.70-0.44). Neuro-QoL measures of fatigue, mobility, positive emotion, and emotional/behavioral control showed responsiveness to self-reported change. CONCLUSIONS: Neuro-QoL is valid for use in PD clinical research. Reliability for all but two measures is sufficient for group comparisons, with some evidence supporting responsiveness to change. Neuro-QoL possesses characteristics, such as brevity, flexibility in administration, and suitability, for cross-disease comparisons that may be advantageous to users in a variety of settings. © 2016 Movement Disorder Society.

Validating Neuro-QoL short forms and targeted scales with people who have multiple sclerosis.

BACKGROUND: Multiple sclerosis (MS) is a chronic, progressive, and disabling disease of the central nervous system with dramatic variations in the combination and severity of symptoms it can produce. The lack of reliable disease-specific health-related quality of life (HRQL) measures for use in clinical trials prompted the development of the Neurology Quality of Life (Neuro-QOL) instrument, which includes 13 scales that assess physical, emotional, cognitive, and social domains, for use in a variety of neurological illnesses. OBJECTIVE: The objective of this research paper is to conduct an initial assessment of the reliability and validation of the Neuro-QOL short forms (SFs) in MS. METHODS: We assessed reliability, concurrent validity, known groups validity, and responsiveness between cross-sectional and longitudinal data in 161 recruited MS patients. RESULTS: Internal consistency was high for all measures (α = 0.81-0.95) and ICCs were within the acceptable range (0.76-0.91); concurrent and known groups validity were highest with the Global HRQL question. Longitudinal assessment was limited by the lack of disease progression in the group. CONCLUSIONS: The Neuro-QOL SFs demonstrate good internal consistency, test-re-test reliability, and concurrent and known groups validity in this MS population, supporting the validity of Neuro-QOL in adults with MS.

A PROMIS Measure of Neuropathic Pain Quality.

OBJECTIVES: Neuropathic pain (NP) is a consequence of many chronic conditions. This study aimed to develop an unidimensional NP scale with scores that represent levels of NP and distinguish between individuals with NP and non-NP conditions. METHODS: A candidate item pool of 42 pain quality descriptors was administered to participants with osteoarthritis, rheumatoid arthritis, diabetic neuropathy, and cancer chemotherapy-induced peripheral neuropathy. A subset of pain quality descriptors (items) that best distinguished between participants with and those without NP conditions were identified. Dimensionality of pain descriptors was evaluated in a development sample and cross-validated in a holdout sample. Item responses were calibrated using an item response theory model, and scores were generated on a T-score metric. NP scale scores were evaluated in terms of the reliability, validity, and ability to distinguish between participants with and without conditions typically associated with NP. RESULTS: Of the 42 initial items, 5 were identified for the Patient-Reported Outcome Measurement Information System (PROMIS) Neuropathic Pain Quality Scale. T scores exhibited good discriminatory ability on the basis of receiver-operator characteristic analysis. Score thresholds that optimize sensitivity and specificity were identified. Construct, criterion, and discriminant validity, and reliability of scale scores were supported. CONCLUSIONS: The five-item Patient-Reported Outcome Measurement Information System (PROMIS PQ-Neuro) Neuropathic Pain Quality Scale is a short and practical measure that can be used to identify patients more likely to have NP and to distinguish levels of NP. The data collected will support future research that targets other unidimensional pain quality domains (e.g., nociceptive pain).

Self-Efficacy Buffers the Relationship between Educational Disadvantage and Executive Functioning.

Previous studies showed that control beliefs are more strongly related to global cognition and mortality among adults with low education, providing preliminary evidence that self-efficacy buffers against the negative impact of educational disadvantage on physical and cognitive health. The current study extends these findings to a nationally representative sample of men and women aged 30 to 85 and explores which cognitive domains are most strongly associated with self-efficacy, educational attainment, and their interaction. Data were obtained from 1032 adult (30-85) participants in the United States norming study for the NIH Toolbox. Self-efficacy, executive functioning, working memory, processing speed, episodic memory, and vocabulary were assessed with the NIH Toolbox. Multivariate analysis of covariance and follow-up regressions tested the hypothesis that self-efficacy would be more strongly related to cognitive performance among individuals with lower education, controlling for age, sex, race, ethnicity, education, reading level, testing language, and depressive symptoms. Higher education was associated with higher self-efficacy and better performance on all cognitive tests. Higher self-efficacy was associated with better set-switching and attention/inhibition. Significant self-efficacy by education interactions indicated that associations between self-efficacy and executive abilities were stronger for individuals with lower education. Specifically, individuals with low education but high self-efficacy performed similarly to individuals with high education. This study provides evidence that self-efficacy beliefs buffer against the negative effects of low educational attainment on executive functioning. These results have implications for future policy and/or intervention work aimed at reducing the deleterious effects of educational disadvantage on later cognitive health.

Validation of the Neuro-QoL measurement system in children with epilepsy.

OBJECTIVE: Children with epilepsy often face complex psychosocial consequences that are not fully captured by existing patient-reported outcome (PRO) measures. The Neurology Quality of Life Measurement System "Neuro-QoL" was developed to provide a set of common PRO measures that address issues important to people with neurologic disorders. This paper reports Neuro-QoL (anxiety, depression, interaction with peers, fatigue, pain, cognitive function, stigma, and upper and lower extremity functions) validation in children with epilepsy. METHOD: Patients (aged 10-18years) diagnosed with epilepsy completed Neuro-QoL and legacy measures at time 1 (initial study visit) and 6-month follow-up. Internal consistency reliability was also evaluated. Concurrent validity was assessed by comparing Neuro-QoL measures with more established "legacy" measures of the same concepts. Clinical validity was evaluated by comparing mean Neuro-QoL scores of patients grouped by clinical anchors such as disease severity. Responsiveness of the Neuro-QoL from time 1 (initial study visit) to 6months was evaluated using self-reported change as the primary anchor. RESULTS: Sixty-one patients (mean age=13.4years; 62.3% male, 75.9% white) participated. Most patients (64.2%) had been seizure-free in the 3months prior to participation, and seizure frequency was otherwise described as follows: 17.8% daily, 13.3% weekly, 35.6% monthly, and 33.3% yearly. All patients were taking antiepileptic drugs. Patients reported better function/less symptoms compared to the reference groups. Internal consistency (alpha) coefficients ranged from 0.76 to 0.87. Patients with different seizure frequencies differed on anxiety (p<.01) and cognitive function (p<.05). Compared to patients on polytherapy, those on monotherapy had better upper extremity scores (p<.05). Compared to those with localized seizures, those experiencing generalized seizures reported worse stigma (p<.05). Depression, anxiety, lower extremity, fatigue, pain, interaction with peers, and stigma also significantly discriminated patients with different levels of quality of life (p≤.05). All Neuro-QoL measures were significantly correlated with other measures assessing similar domains. Stigma was related to self-reported change in several areas of functioning but in sometimes unexpected directions. SIGNIFICANCE: The Neurology Quality of Life Measurement System is a valid and reliable assessment tool for children with epilepsy and can be used in research and clinical settings.

The impact of symptom burden on patient quality of life in chronic myeloid leukemia.

Patients with chronic myeloid leukemia (CML) in chronic phase are living longer on BCR-ABL1 tyrosine kinase inhibitor (TKI) therapy, placing emphasis on issues related to symptom burden and quality of life (QoL). Furthermore, the potential for adverse events with longer-term therapy may result in dose adjustments, treatment discontinuation, or nonadherence, all of which may negatively affect treatment efficacy and QoL. However, instruments to specifically measure the impact of symptom burden and treatment on health-related QoL in patients with CML have not been widely available until recently. The FACT-Leu is a validated tool that measures leukemia-specific and more general QoL concerns. Other tools specific to CML, including the MDASI-CML and the EORTC QLQ-CML24, are undergoing validation. Here, we describe TKI therapy-related symptom burden and its effect on adherence and treatment response, outline instruments to measure symptom burden and QoL in CML, and summarize the available clinical data on QoL of patients on TKI therapy. QoL is an aspect of CML disease management that will continue to gain prominence in the coming years. We believe that the instruments developed now will have a role in informing treatment decisions in routine practice and allowing clinicians to proactively address issues related to symptom burden and QoL.

Which psychosocial factors best predict cognitive performance in older adults?

Negative affect (e.g., depression) is associated with accelerated age-related cognitive decline and heightened dementia risk. Fewer studies examine positive psychosocial factors (e.g., emotional support, self-efficacy) in cognitive aging. Preliminary reports suggest that these variables predict slower cognitive decline independent of negative affect. No reports have examined these factors in a single model to determine which best relate to cognition. Data from 482 individuals 55 and older came from the normative sample for the NIH Toolbox for the Assessment of Neurological and Behavioral Function. Negative and positive psychosocial factors, executive functioning, working memory, processing speed, and episodic memory were measured with the NIH Toolbox Emotion and Cognition modules. Confirmatory factor analysis and structural equation modeling characterized independent relations between psychosocial factors and cognition. Psychosocial variables loaded onto negative and positive factors. Independent of education, negative affect and health status, greater emotional support was associated with better task-switching and processing speed. Greater self-efficacy was associated with better working memory. Negative affect was not independently associated with any cognitive variables. Findings support the conceptual distinctness of negative and positive psychosocial factors in older adults. Emotional support and self-efficacy may be more closely tied to cognition than other psychosocial variables.

The cognition battery of the NIH toolbox for assessment of neurological and behavioral function: validation in an adult sample.

This study introduces a special series on validity studies of the Cognition Battery (CB) from the U.S. National Institutes of Health Toolbox for the Assessment of Neurological and Behavioral Function (NIHTB) (Gershon, Wagster et al., 2013) in an adult sample. This first study in the series describes the sample, each of the seven instruments in the NIHTB-CB briefly, and the general approach to data analysis. Data are provided on test-retest reliability and practice effects, and raw scores (mean, standard deviation, range) are presented for each instrument and the gold standard instruments used to measure construct validity. Accompanying papers provide details on each instrument, including information about instrument development, psychometric properties, age and education effects on performance, and convergent and discriminant construct validity. One study in the series is devoted to a factor analysis of the NIHTB-CB in adults and another describes the psychometric properties of three composite scores derived from the individual measures representing fluid and crystallized abilities and their combination. The NIHTB-CB is designed to provide a brief, comprehensive, common set of measures to allow comparisons among disparate studies and to improve scientific communication.

Validity of the Neurology Quality-of-Life (Neuro-QoL) measurement system in adult epilepsy.

Epilepsy is a chronic neurological disorder that results in recurring seizures and can have a significant adverse effect on health-related quality of life (HRQL). The Neuro-QoL measurement initiative is an NINDS-funded system of patient-reported outcome measures for neurology clinical research, which was designed to provide a precise and standardized way to measure HRQL in epilepsy and other neurological disorders. Using mixed-method and item response theory-based approaches, we developed generic item banks and targeted scales for adults and children with major neurological disorders. This paper provides empirical results from a clinical validation study with a sample of adults diagnosed with epilepsy. One hundred twenty-one people diagnosed with epilepsy participated, the majority of which were male (62%) and Caucasian (95%), with a mean age of 47.3 (SD=16.9). Baseline assessments included Neuro-QoL short forms and general and external validity measures. The Neuro-QoL short forms that are not typically found in other epilepsy-specific HRQL instruments include Stigma, Sleep Disturbance, Emotional and Behavioral Dyscontrol, and Positive Affect and Well-Being. Neurology Quality-of-Life short forms demonstrated adequate reliability (internal consistency range=.86-.96; test-retest range=.57-.89). Pearson correlations (p<.01) between Neuro-QoL forms of emotional distress (anxiety, depression, stigma) and the QOLIE-31 Emotional Well-Being subscale were in the moderate-to-strong range (r's=.66, .71 and .53, respectively), as were relations with the PROMIS Global Mental Health subscale (r's=.59, .74 and .52, respectively). Moderate correlations were observed between Neuro-QoL Social Role Performance and Satisfaction and the QOLIE-31 Social Function (r's=.58 and .52, respectively). In measuring aspects of physical function, the Neuro-QoL Mobility and Upper Extremity forms demonstrated moderate associations with the PROMIS Global Physical Function subscale (r's=.60 and .61, respectively). Neuro-QoL measures of perceived cognitive function (executive function and general concerns) produced moderate-to-strong correlations with the QOLIE-31 Cognition subscale (r's=.65 and .75, respectively) and moderate relations with the Liverpool Adverse Events Profile (r's=.51 and .69, respectively). Finally, the Neuro-QoL Fatigue measure demonstrated moderate associations with the QOLIE-31 Energy/Fatigue subscale (r=-.65), Liverpool Adverse Events Profile (r=.69), and the Liverpool Seizure Severity Scale (r=.50). Five Neuro-QoL short forms demonstrated statistically significant responsiveness to change at 5-7months, including Fatigue, Sleep Disturbance, Depression, Positive Affect and Well-Being, and Emotional and Behavioral Dyscontrol. Overall, Neuro-QoL instruments showed good evidence for internal consistency, test-retest reliability, convergent validity, and responsiveness to change over several months. These results support the validity of Neuro-QoL to measure HRQL in adults with epilepsy.

Parent-reported cognition of children with cancer and its potential clinical usefulness.

PURPOSE: Cognitive dysfunction is a common concern for children with brain tumors (BTs) or those receiving central nervous system (CNS) toxic cancer treatments. Perceived cognitive function (PCF) is an economical screening that may be used to trigger full, formal cognitive testing. We assessed the potential clinical utility of PCF by comparing parent-reported scores for children with cancer with scores from the general US population. METHODS: Children (n = 515; mean age = 13.5 years; 57.0 % male) and one of their parents were recruited from pediatric oncology clinics. Most children (53.3 %) had a diagnosis of CNS tumor with an average time since diagnosis of 5.6 years. PCF was evaluated using the pediatric PCF item bank (pedsPCF), which was developed and normed on a sample drawn from the US general pediatric population. Children also completed computer-based neuropsychological tests. We tested relationships between PCF and clinical variables. Differential item functioning (DIF) was used to evaluate measurement bias between the samples. RESULTS: No item showed DIF, supporting the use of pedsPCF in the cancer sample. PedsPCF differentiated children with (vs. without) a BT, p < 0.01, and groups defined by years since diagnosis, p < 0.01. It significantly (p < 0.05) correlated with computerized neuropsychological tests in 40 of 60 comparisons. Children with BTs were rated as having worse pedsPCF scores than the norm, regardless of years since diagnosis. CONCLUSIONS: PCF significantly differentiated cancer survivors with various clinical characteristics. It is brief and easy to implement. PCF should be considered for routine care of pediatric cancer survivors.

Remote Self-Administration of Cognitive Screeners for Older Adults Prior to a Primary Care Visit: Pilot Cross-Sectional Study of the Reliability and Usability of the MyCog Mobile Screening App.

BACKGROUND: Routine cognitive screening is essential in the early detection of dementia, but time constraints in primary care settings often limit clinicians' ability to conduct screenings. MyCog Mobile is a newly developed cognitive screening system that patients can self-administer on their smartphones before a primary care visit, which can help save clinics' time, encourage broader screening practices, and increase early detection of cognitive decline. OBJECTIVE: The goal of this pilot study was to examine the feasibility, acceptability, and initial psychometric properties of MyCog Mobile. Research questions included (1) Can older adults complete MyCog Mobile remotely without staff support? (2) Are the internal consistency and test-retest reliability of the measures acceptable? and (3) How do participants rate the user experience of MyCog Mobile? METHODS: A sample of adults aged 65 years and older (N=51) self-administered the MyCog Mobile measures remotely on their smartphones twice within a 2- to 3-week interval. The pilot version of MyCog Mobile includes 4 activities: MyFaces measures facial memory, MySorting measures executive functioning, MySequences measures working memory, and MyPictures measures episodic memory. After their first administration, participants also completed a modified version of the Simplified System Usability Scale (S-SUS) and 2 custom survey items. RESULTS: All participants in the sample passed the practice items and completed each measure. Findings indicate that the Mobile Toolbox assessments measure the constructs well (internal consistency 0.73 to 0.91) and are stable over an approximately 2-week delay (test-retest reliability 0.61 to 0.71). Participants' rating of the user experience (mean S-SUS score 73.17, SD 19.27) indicated that older adults found the usability of MyCog Mobile to be above average. On free-response feedback items, most participants provided positive feedback or no feedback at all, but some indicated a need for clarity in certain task instructions, concerns about participants' abilities, desire to be able to contact a support person or use in-app technical support, and desire for additional practice items. CONCLUSIONS: Pilot evidence suggests that the MyCog Mobile cognitive screener can be reliably self-administered by older adults on their smartphones. Participants in our study generally provided positive feedback about the MyCog Mobile experience and rated the usability of the app highly. Based on participant feedback, we will conduct further usability research to improve support functionality, optimize task instructions and practice opportunities, and ensure that patients feel comfortable using MyCog Mobile. The next steps include a clinical validation study that compares MyCog Mobile to gold-standard assessments and tests the sensitivity and specificity of the measures for identifying dementia.

Protocol for a construct and clinical validation study of MyCog Mobile: a remote smartphone-based cognitive screener for older adults.

INTRODUCTION: Annual cognitive screening in older adults is essential for early detection of cognitive impairment, yet primary care settings face time constraints that present barriers to routine screening. A remote cognitive screener completed on a patient's personal smartphone before a visit has the potential to save primary care clinics time, encourage broader screening practices and increase early detection of cognitive decline. MyCog Mobile is a promising new remote smartphone-based cognitive screening app for primary care settings. We propose a combined construct and clinical validation study of MyCog Mobile. METHODS AND ANALYSIS: We will recruit a total sample of 300 adult participants aged 65 years and older. A subsample of 200 healthy adult participants and a subsample of 100 adults with a cognitive impairment diagnosis (ie, dementia, mild cognitive impairment, cognitive deficits or other memory loss) will be recruited from the general population and specialty memory care centres, respectively. To evaluate the construct validity of MyCog Mobile, the healthy control sample will self-administer MyCog Mobile on study-provided smartphones and be administered a battery of gold-standard neuropsychological assessments. We will compare correlations between performance on MyCog Mobile and measures of similar and dissimilar constructs to evaluate convergent and discriminant validity. To assess clinical validity, participants in the clinical sample will self-administer MyCog Mobile on a smartphone and be administered a Mini-Cog screener and these data will be combined with the healthy control sample. We will then apply several supervised model types to determine the best predictors of cognitive impairment within the sample. Area under the receiver operating characteristic curve, accuracy, sensitivity and specificity will be the primary performance metrics for clinical validity. ETHICS AND DISSEMINATION: The Institutional Review Board at Northwestern University (STU00214921) approved this study protocol. Results will be published in peer-reviewed journals and summaries provided to the study's funders.