Confirmatory factor analysis was used the evaluate the dimensional structure underlying the NIH Toolbox Cognition Battery (CB) and the measures chosen to serve as concurrent validity criteria for the NIH Toolbox CB. These results were used to evaluate the convergent and discriminant validity of the CB in children ranging from 3 to 15 years of age. Results were evaluated separately for a 3- to 6-year-old group and a 8- to 15-year-old group because different validation measures were used in these age groups. Three distinct dimensions were found for the 3- to 6-year-old group: Vocabulary, Reading, and Fluid Abilities. Five dimensions were found for 8-15 year olds: Vocabulary, Reading, Episodic Memory, Working Memory, and Executive Function/Processing Speed. CB measures and their validation analogues consistently defined common factors in a pattern that broadly supported the convergent and discriminant validity of the CB, but results showed higher intercorrelation and less differentiation of cognitive dimensions in younger than in older children and in older children compared with adults. Age was strongly related to the cognitive dimensions underlying test performance in both groups of children and results are consistent with broader literature showing increasing differentiation of cognitive abilities associated with the rapid brain development that occurs from early childhood into adulthood.

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.

Language facilitates communication and efficient encoding of thought and experience. Because of its essential role in early childhood development, in educational achievement and in subsequent life adaptation, language was included as one of the subdomains in the NIH Toolbox for the Assessment of Neurological and Behavioral Function Cognition Battery (NIHTB-CB). There are many different components of language functioning, including syntactic processing (i.e., morphology and grammar) and lexical semantics. For purposes of the NIHTB-CB, two tests of language--a picture vocabulary test and a reading recognition test--were selected by consensus based on literature reviews, iterative expert input, and a desire to assess in English and Spanish. NIHTB-CB's picture vocabulary and reading recognition tests are administered using computer adaptive testing and scored using item response theory. Data are presented from the validation of the English versions in a sample of adults ages 20-85 years (Spanish results will be presented in a future publication). Both tests demonstrated high test-retest reliability and good construct validity compared to corresponding gold-standard measures. Scores on the NIH Toolbox measures were consistent with age-related expectations, namely, growth in language during early development, with relative stabilization into late adulthood.

Pre-Conference Workshop in conjunction with the Annual Meeting of the Geriatrics Society of America San Diego Convention Center, San Diego, CA, USA, 14 November 2012 In 2004, the NIH awarded contracts to initiate the development of high-quality psychological and neuropsychological outcome measures for the improved assessment of health-related outcomes. The workshop introduced these measurement development initiatives, the measures created and the NIH-supported resource (Assessment Center) for internet or tablet-based test administration and scoring. Presentations covered item response theory and assessment of test bias, construction of item banks and computerized adaptive testing, and the different ways in which qualitative analyses contribute to the definition of construct domains and the refinement of outcome constructs. The panel discussion included questions about representativeness of samples and the assessment of cultural bias.

The NIH Toolbox Cognition Battery (CB) includes 7 tests covering 6 cognitive abilities. This chapter describes the psychometric characteristics in children ages 3-15 years of a total summary score and composite scores reflecting two major types of cognition: "crystallized" (more dependent upon past learning experiences) and "fluid" (capacity for new learning and information processing in novel situations). Both types of cognition are considered important in everyday functioning, but are thought to be differently affected by brain health status throughout life, from early childhood through older adulthood. All three Toolbox composite scores showed excellent test-retest reliability, robust developmental effects across the childhood age range considered here, and strong correlations with established measures of similar abilities. Additional preliminary evidence of validity includes significant associations between all three Toolbox composite scores and maternal reports of children's health status and school performance.

Background

Recent advances in understanding molecular and synaptic mechanisms of intellectual disabilities (ID) in fragile X syndrome (FXS) and Down syndrome (DS) through animal models have led to targeted controlled trials with pharmacological agents designed to normalize these underlying mechanisms and improve clinical outcomes. However, several human clinical trials have failed to demonstrate efficacy of these targeted treatments to improve surrogate behavioral endpoints. Because the ultimate index of disease modification in these disorders is amelioration of ID, the validation of cognitive measures for tracking treatment response is essential. Here, we present preliminary research to validate the National Institutes of Health Toolbox Cognitive Battery (NIH-TCB) for ID.

Methods

We completed three pilot studies of patients with FXS (total n = 63; mean age 19.3 ± 8.3 years, mean mental age 5.3 ± 1.6 years), DS (n = 47; mean age 16.1 ± 6.2, mean mental age 5.4 ± 2.0), and idiopathic ID (IID; n = 16; mean age 16.1 ± 5.0, mean mental age 6.6 ± 2.3) measuring processing speed, executive function, episodic memory, word/letter reading, receptive vocabulary, and working memory using the web-based NIH-TB-CB, addressing feasibility, test-retest reliability, construct validity, ecological validity, and syndrome differences and profiles.

Results

Feasibility was good to excellent (≥80 % of participants with valid scores) for above mental age 4 years for all tests except list sorting (working memory). Test-retest stability was good to excellent, and convergent validity was similar to or better than results obtained from typically developing children in the normal sample for executive function and language measures. Examination of ecological validity revealed moderate to very strong correlations between the NIH-TCB composite and adaptive behavior and full-scale IQ measures. Syndrome/group comparisons demonstrated significant deficits for the FXS and DS groups relative to IID on attention and inhibitory control, a significant reading weakness for FXS, and a receptive vocabulary weakness for DS.

Conclusions

The NIH-TCB has potential for assessing important dimensions of cognition in persons with ID, and several tests may be useful for tracking response to intervention. However, more extensive psychometric studies, evaluation of the NIH-TCB's sensitivity to change, both developmentally and in the context of treatment, and perhaps establishing links to brain function in these populations, are required to determine the true utility of the battery as a set of outcome measures.

Objective

This study examined the influence of Hispanic ethnicity and language/cultural background on performance on the NIH Toolbox Cognition Battery (NIHTB-CB).

Method

Participants included healthy, primarily English-speaking Hispanic (n = 93; Hispanic-English), primarily Spanish-speaking Hispanic (n = 93; Hispanic-Spanish), and English speaking Non-Hispanic white (n = 93; NH white) adults matched on age, sex, and education levels. All participants were in the NIH Toolbox national norming project and completed the Fluid and Crystallized components of the NIHTB-CB. T-scores (demographically-unadjusted) were developed based on the current sample and were used in analyses.

Results

Spanish-speaking Hispanics performed worse than English-speaking Hispanics and NH whites on demographically unadjusted NIHTB-CB Fluid Composite scores (ps < .01). Results on individual measures comprising the Fluid Composite showed significant group differences on tests of executive inhibitory control (p = .001), processing speed (p = .003), and working memory (p < .001), but not on tests of cognitive flexibility or episodic memory. Test performances were associated with language/cultural backgrounds in the Hispanic-Spanish group: better vocabularies and reading were predicted by being born outside the U.S., having Spanish as a first language, attending school outside the U.S., and speaking more Spanish at home. However, many of these same background factors were associated with worse Fluid Composites within the Hispanic-Spanish group.

Conclusions

On tests of Fluid cognition, the Hispanic-Spanish group performed the poorest of all groups. Socio-demographic and linguistic factors were associated with those differences. These findings highlight the importance of considering language/cultural backgrounds when interpreting neuropsychological test performances. Importantly, after applying previously published NIHTB-CB norms with demographic corrections, these language/ethnic group differences are eliminated.

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.

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.

Background

There is a need for valid self-report measures of core health-related quality of life (HRQoL) domains.

Objective

To derive brief, reliable and valid health profile measures from the Patient Reported Outcomes Measurement Information System^® (PROMIS^®) item banks.

Methods

Literature review, investigator consensus process, item response theory (IRT) analysis, and expert review of scaling results from multiple PROMIS data sets. We developed 3 profile measures ranging in length from 29 to 57 questions. These profiles assess important HRQoL domains with highly informative subsets of items from respective item banks and yield reliable information across mild-to-severe levels of HRQoL experiences. Each instrument assesses the domains of pain interference, fatigue, depression, anxiety, sleep disturbance, physical function, and social function using 4-, 6-, and 8-item short forms for each domain, and an average pain intensity domain score, using a 0-10 numeric rating scale.

Results

With few exceptions, all domain short forms within the profile measures were highly reliable across at least 3 standard deviation (30 T-score) units and were strongly correlated with the full bank scores. Construct validity with ratings of general health and quality of life was demonstrated. Information to inform statistical power for clinical and general population samples is also provided.

Conclusions

Although these profile measures have been used widely, with summary scoring routines published, description of their development, reliability, and initial validity has not been published until this article. Further evaluation of these measures and clinical applications are encouraged.